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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the Quarterly Period Ended September 30, 2024

 

or

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the Transition Period from _________ to _________

 

Commission file number: 000-21990

 

Oncotelic Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   13-3679168
(State or other jurisdiction   (I.R.S. Employer
of incorporation or organization)   Identification No.)

 

29397 Agoura Road Suite 107    
Agoura Hills, CA   91301
(Address of principal executive offices)   (Zip Code)

 

(650) 635-7000

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of exchange on which registered
None   OTLC   N/A

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a small reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” a “smaller reporting company” and an “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer   Accelerated filer
         
Non-accelerated filer   Smaller reporting company
         
      Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act: ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No

 

As of November 18, 2024, there were 407,289,618 shares of the registrant’s common stock outstanding.

 

 

 

 

 

 

ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES

FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2024

 

TABLE OF CONTENTS

 

    Page
     
PART I. FINANCIAL INFORMATION 3
     
ITEM 1. Financial Statements (unaudited) 3
     
  Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023 3
     
  Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2024 and 2023 4
     
  Consolidated Statements of Changes in Stockholders’ Equity for the Three Months and Nine Months Ended September 30, 2024 and 2023 5
     
  Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023 7
     
  Notes to Consolidated Financial Statements 8
     
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 37
     
ITEM 3. Quantitative and Qualitative Disclosures about Market Risk 50
     
ITEM 4. Controls and Procedures 50
     
PART II. OTHER INFORMATION 52
     
ITEM 1. Legal Proceedings 52
     
ITEM 1A. Risk Factors 52
     
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 52
     
ITEM 3. Defaults Upon Senior Securities 52
   
ITEM 4. Mine Safety Disclosures 52
     
ITEM 5. Other Information 52
     
ITEM 6. Exhibits, Financial Statement Schedules 53
     
SIGNATURES 55

 

2

 

 

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

   September 30,   December 31, 
   2024   2023 
         
ASSETS          
Current assets:          
Cash  $149,018   $170,405 
Restricted cash   20,000   $20,000 
Accounts receivable   18,976    18,976 
Prepaid & other current assets   51,036    62,356 
           
Total current assets   239,030    271,737 
           
In process R&D   1,101,760    1,101,760 
Goodwill, net of impairment   2,788,230    5,988,230 
Investment in GMP Bio at fair value   22,653,225    22,653,225 
Total assets  $26,782,245   $30,014,952 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable and accrued liabilities  $2,462,123   $2,437,321 
Accounts payable - related party   345,543    344,099 
Contingent consideration   2,625,000    2,625,000 
Derivative liability on notes   282,386    423,214 
Convertible and short-term debt, net of costs   7,743,936    8,066,957 
Convertible debt and short-term debt - related party, net of costs   2,898,392    2,608,356 
           
Total current liabilities   16,357,380    16,504,947 
           
Convertible long-term debt, net of costs   2,167,893    1,898,468 
Convertible long-term debt, related party   125,000    - 
Total noncurrent liabilities   2,292,893    1,898,468 
Total liabilities   18,650,273     18,403,415  
Commitments and contingencies (Note 14)   -     -  
           
Stockholders’ equity:          
Common stock, $.01 par value; 750,000,000 shares authorized; 407,289,618 and 399,184,128 issued and outstanding, respectively   4,072,899    3,991,839 
Additional paid-in capital   42,219,400    41,655,026 
Accumulated deficit   (37,439,735)   (33,516,736)
           
Total Oncotelic Therapeutics, Inc. stockholders’ equity   8,852,564    12,130,129 
Non-controlling interests   (720,592)   (518,592)
           
Total stockholders’ equity   8,131,972    11,611,537 
Total liabilities and stockholders’ equity  $26,782,245   $30,014,952 

 

The accompanying footnotes are an integral part of these unaudited consolidated financial statements.

 

3

 

 

ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

For the Three MONTHS AND NINE MONTHS ended SEPTEMBER 30, 2024 and 2023

(Unaudited)

 

   2024   2023   2024   2023 
  

For the Three Months Ended

September 30,

  

For the Nine Months Ended

September 30,

 
   2024   2023   2024   2023 
                 
Service Revenue  $-   $70,000   $-   $70,000 
Total Revenue   -    70,000    -    70,000 
                     
Operating expenses:                    
Research and development  $480   $21,221   $1,212   $50,148 
General and administrative   80,277    34,301    343,347    471,258 
Goodwill impairment (See note 2 and 3)   3,200,000    -    3,200,000    6,083,146 
Total operating expenses   3,280,757    55,522    3,544,559    6,604,552 
                     
Income/(Loss) from operations   (3,280,757)   14,478    (3,544,559)   (6,534,552)
Other income (expense):                    
Interest expense, net   (205,616)   (185,424)   (655,946)   (837,100)
Reimbursement for expenses - related party   -    -    22,937    72,246 
Change in fair value of derivative on debt   114,722    306,836    140,828    (20,758)
Loss on debt conversion   -    (94,829)   (88,258)   (94,829)
Total other income (expense)   (90,894)   26,583    (580,439)   (880,441)
Net income (loss) before non-controlling interests   (3,371,651)   41,061    (4,124,998)   (7,414,993)
Net loss attributable to non-controlling interests   (67,165)   (74,248)   (202,000)   (247,883)
Net income (loss) attributable to Oncotelic Therapeutics, Inc.  $(3,304,486)  $115,309   $(3,922,998)  $(7,167,110)
                     
Basic net loss per share attributable to common stock  $(0.01)  $0.00   $(0.01)  $(0.02)
Basic weighted average common stock outstanding   407,289,888    397,777,882    403,428,494    395,237,893 
                     
Diluted net loss per share attributable to common stock  $(0.01)  $0.00   $(0.01)  $(0.02)
Diluted weighted average common stock outstanding   407,289,888    397,777,882    403,428,494    395,237,893 

 

The accompanying footnotes are an integral part of these unaudited consolidated financial statements.

 

4

 

 

ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES

Consolidated STATEMENT of STOCKHOLDERS’ EQUITY

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2024

(Unaudited)

 

                   Additional             
   Preferred Stock   Common Stock   Paid-in   Accumulated   Non-controlling   Stockholders’ 
   Shares   Amount   Shares   Amount   Capital   Deficit   Interests   Equity 
                                 
Balance at January 1, 2024   -   $-    399,184,128   $3,991,839   $41,655,026   $(33,516,736)  $(518,592)  $11,611,537 
Common shares issued upon partial conversion of debt   -    -    500,000    5,000    108,029         -   113,029 
Net Loss                          (408,676)   (66,499)  (475,175)
Balance at March 31, 2024   -                  -    399,684,128    3,996,839    41,763,055    (33,925,412)   (585,091)  11,249,391 
                                         
Common shares issued upon partial conversion of debt             7,605,760    76,060    456,345             532,405 
Net loss   -    -                   (209,837)   (68,336)  (278,173)
Balance at June 30, 2024   -   -    407,289,888   $4,072,899   $42,219,400   $(34,135,249)  $(653,427)  11,503,623 
                                         
Net loss   -    -        -     -     (3,304,486)   (67,165)  (3,371,651)
Balance at September 30, 2024   -   $-    407,289,888    4,072,899    42,219,400    (37,439,735)   (720,592)  $8,131,972 

 

The accompanying footnotes are an integral part of these unaudited consolidated financial statements.

 

5

 

 

ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES

Consolidated STATEMENT of STOCKHOLDERS’ EQUITY

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2023

(Unaudited)

 

                   Additional       Non     
   Preferred Stock   Common Stock   Paid-in   Accumulated   controlling   Stockholders’ 
   Shares   Amount   Shares   Amount   Capital   Deficit   Interests   Equity 
                                 
Balance at January 1, 2023   -   $-    391,846,880   $3,918,469   $     41,416,632   $     (25,926,069)  $       (215,620)  $        19,193,412 
Adpotion of ASU 2020-06   -         -         (521,749)   312,426        (209,323)
Common shares issued upon partial conversion of debt             1,025,000    10,250    61,499    -    -    71,749 
Net loss   -    -    -              (525,419)   (80,625)   (606,044)
Balance at March 31, 2023   -    -    392,871,880    3,928,719    40,956,382    (26,139,062)   (296,245)   18,449,794 
                                         
Common shares issued in connection with debt conversion   -    -    4,659,710    46,597    279,566    -    -    326,163 
Net income/(loss)   -    -    -    -    -    (6,757,000)   (93,010)   (6,850,010)
 Balance as of June 30, 2023   -   $-    397,531,590   $3,975,316   $41,235,948   $(32,896,062)  $(389,255)  $11,925,947 
                                         
Common shares issued in connection with debt conversion   -    -    627,538    6,273    28,994    -         35,267 
Loss on extinguishment of PPM debt                       98,429              98,429 
Allocation of cost of warrants for PPM Debt                       (15,158)             (15,158)
In connection with debt debt conversion   -    -         -         -         - 
Net income(loss)   -    -    -    -    -    115,309    (74,248)   41,061 
 Balance as of September 30, 2023   -   $-    398,159,128    3,981,589    41,348,213    (32,780,753)   (463,503)  $12,085,546 

 

The accompanying footnotes are an integral part of these unaudited consolidated financial statements.

 

6

 

 

ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES

Consolidated STATEMENTS OF CASH FLOWS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023

(Unaudited)

 

   2024   2023 
   For the Nine Months Ended September 30, 
   2024   2023 
Cash flows from operating activities:          
Net income (loss)  $(4,124,998)  $(7,414,993)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:          
Goodwill impairment   3,200,000   6,083,146 
Amortization of debt discount and deferred finance costs   117,132    - 
Change in fair value of derivative   (140,828)   20,758 
Loss on debt conversion   88,258    94,829 
Changes in operating assets and liabilities:          
Prepaid expenses and other current assets   11,320    (39,768)
Accounts payable and accrued expenses   211,285    367,348 
Accounts payable to related party   1,444    (59,750)
Net cash used in operating activities   (636,387)   (948,430)
           
Cash flows from financing activities:          
Proceeds from / (repayment to) private placement   -    (100,000)
Proceeds from convertible notes and short term loans, others   615,000    1,110,000 
Repaid to others   -    (35,000)
Net cash provided by financing activities   615,000    975,000 
           
Net increase (decrease) in cash   (21,387)   26,570 
           
Cash and restricted cash - beginning of period   190,405    261,452 
           
Cash and restricted cash - end of period  $169,018   $288,022 
           
Supplemental cash flow information:          
Cash paid for:          
Interest paid  $281,260   $296,186 
Non-cash investing and financing activities:          
Warrants issued in connection with private placement  $-   $83,271 
Common shares issued upon partial conversion of debt  $645,434   $433,179 
Beneficial Conversion Feature on convertible debt and restricted common shares  $-   $(209,323)

 

The accompanying footnotes are an integral part of these unaudited condensed consolidated financial statements.

 

7

 

 

ONCOTELIC THERAPEUTICS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

NOTE 1 – DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION

 

Description of Business

 

Oncotelic Therapeutics, Inc. (“Oncotelic”), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic conducts business activities through Oncotelic and its wholly owned subsidiaries, Oncotelic, Inc., a Delaware corporation, PointR Data, Inc. (“PointR”), a Delaware corporation; Pet2DAO, Inc (“Pet2DAO”) and EdgePoint AI, Inc. (“Edgepoint”), a Delaware Corporation for which there are non-controlling interests, (Oncotelic, Oncotelic Inc., PointR, Pet2DAO and Edgepoint are collectively called the “Company” or “We”). The Company completed a reverse merger with Oncotelic Inc in April 2019, a merger with PointR in November 2019 and formed a subsidiary Edgepoint in February 2020. For more information on these mergers, refer to our 2022 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

The Company is currently developing OT-101, through its joint venture (“JV”) with Dragon Overseas Capital Limited (“Dragon”) and GMP Biotechnology Limited (“GMP Bio”), both affiliates of Golden Mountain Partners (“GMP”), for various cancers and COVID-19, Artemisinin for COVID-19 and AI technologies for clinical development and manufacturing. The Company is also independently planning to develop OT-101 for certain animal health indications and contemplating using crypto currencies for that platform. The Company acquired apomorphine for Parkinson’s Disease, erectile dysfunction and female sexual dysfunction. In addition, the Company is evaluating the further development of its product candidates OXi4503, as a treatment for acute myeloid leukemia and myelodysplastic syndromes, and CA4P, in combination with a checkpoint inhibitor for the treatment of advanced metastatic melanoma.

 

The Company is primarily a cancer immunotherapy company dedicated to the development of first in class self-immunization protocol (“SIP™”) candidates for difficult to treat cancers. The Company’s proprietary SIP™ candidates are expected to offer advantages over other immunotherapies because they do not require extraction of the tumor or isolation of the antigens, and they have the potential for broad-spectrum applicability for multiple cancer types. The Company’s proprietary product candidates have shown promising clinical activity in phase 2 trials for the treatment of gliomas and pancreatic cancers. The Company aims to translate its unique insights, which span more than three decades of original work using RNA therapeutics, into the deployment of antisense as a RNA therapeutic for diseases which are caused by TGF-β overexpression, starting with cancer and expanding to Duchenne Muscular Dystrophy (“DMD”) and others. OT-101, is being developed as a broad-spectrum anti-cancer drug that can also be used in combination with other standard cancer therapies to establish an effective multi-modality treatment strategy for difficult-to-treat cancers. The JV plans to initiate phase 2 and 3 clinical trials for OT-101 in both high-grade glioma and pancreatic cancer, and any other indications that may evolve, for human pharmaceutical needs. The JV may also be sponsoring investigator-initiated studies for OT-101 for other oncology indications. The Company is evaluating the further development of its product candidates OXi4503, as a treatment for acute myeloid leukemia and myelodysplastic syndromes, and CA4P, in combination with a checkpoint inhibitor for the treatment of advanced metastatic melanoma. The JV is also developing OT-101 for the various epidemics and pandemics, similar to the corona virus (“COVID-19”) pandemic. In this connection, the Company entered into an agreement and supplemental agreement with GMP for a total of $1.2 million to render services and was paid for the development of OT-101. The Company was working with the Biomedical Advanced Research and Development Authority (“BARDA”) to conduct an observational study to evaluate the effects of long COVID-19 and had been provided a grant of up to $0.75 million for the study; however, BARDA discontinued that program with the Company. In 2020 and 2021, the Company was developing Artemisinin as a potential therapy for COVID-19. Artemisinin, purified from a plant Artemisia annua. For more information on GMP and Artemisinin, refer to our 2023 Annual report on Form 10- K filed with the SEC on April 12, 2024.

 

8

 

 

Fundraising

 

Private Placement 2 & JH Darbie Financing

 

Between July 2023 and September 2023, the Company entered into a series of subscription agreements with 15 accredited investors which resulted in a conversion of a gross amount of $1.0 million, consisting of 40 notes, under the prior JH Darbie Financing into new debt to the Company. JH Darbie and the Company are parties to a March 2023 placement agent agreement (“Agreement”) pursuant to which JH Darbie has the right to sell/convert a minimum of 10 Units and a maximum of 200 Units on a best-efforts basis. Further, in October 2023, the Company entered into a series of subscription agreements with 27 accredited investors which resulted in a conversion of a gross amount of $1.05 million, consisting of 42 notes, under the prior JH Darbie Financing into new debt to the Company. Additionally, in January 2024, Company entered into a series of subscription agreements with 4 accredited investors which resulted in a conversion of a gross amount of $0.3 million, consisting of 12 notes. The July 2023, October 2023 and January 2024 conversions fully converted JH Darbie PPM-1 notes into PPM-2 notes. For more information on the new JH Darbie Financing, refer to Note 8 of these Notes to the Consolidated Financial Statements.

 

J.H. Darbie Financing Notes & Issuance of Oncotelic Warrants

 

In February 2022, the Company and 99 out of 100 of the Investors agreed to extend the maturity date of the notes connected to the Units from March 31, 2022 to March 31, 2023. In addition, the Company issued approximately 33 million warrants to purchase $50,000 of shares of common stock of the Company (“Common Stock’) in connection with agreeing to extend the maturity date by one year. The issuance of the additional warrants resulted in the Company recording an expense of approximately $2.9 million in the Company’s statement of operations during the year ended December 31, 2022. The approximately 33 million warrants to purchase shares of our Common Stock expired on March 31, 2024. For more information on the JD Darbie financing, refer to Note 7 of these unaudited Notes to the Consolidated Financial Statements.

 

Equity Purchase Agreement

 

In May 2021, the Company entered into an Equity Purchase Agreement (the “EPL”) and Registration Rights Agreement (the “Registration Rights Agreement”) with Peak One Opportunity Fund, L.P. (“Peak One”), pursuant to which the Company shall have the right, but not the obligation, to direct Peak One to purchase up to $10.0 million (the “Maximum Commitment Amount”) in shares of the common stock, par value $0.01 per share (“Common Stock”) in multiple tranches. The Company filed a post-effective amendment for the EPL on April 12, 2024 with the SEC and the SEC has made the post-effective amendment effective on April 22, 2024. The Company filed a prospectus under rule 424b3 with the SEC on April 26, 2024. For more information on the EPL, refer to Note 10 of the Notes to the Unaudited Consolidated Financial Statements.

 

9

 

 

August 2021 Notes

 

In August 2021, the Company issued Note Purchase Agreements with Autotelic Inc., the Company’s Chief Financial Officer (“CFO”), and certain other accredited investors. Under the terms of the Note Purchase Agreements, the Company issued an aggregate of $698,500 (the “Principal Amount”) in debt in the form of unsecured convertible promissory notes (collectively, the “Notes”). The Notes are unsecured, and provide for interest at the rate of 5% per annum. For more information on the debt financing of the Company, refer to Note 5 of the Notes to the Consolidated Financial Statements.

 

November-December 2021 and March 2022 Notes

 

In November / December 2021, the Company entered into various Securities Purchase Agreements with Talos Victory Fund, LLC (the (“Talos”), Mast Hill Fund, LP (“Mast”), FirstFire Global Opportunities Fund, LLC (“FirstFire”), Blue Lake Partners, LLC (“Blue Lake”) and Fourth Man, LLC (“Fourth Man”), pursuant to which the Company issued convertible promissory notes in the aggregate principal amount of $0.25 million each, aggregating gross $1.25 million (the “Notes”), and which Notes were convertible into shares of the Company’s common stock, par value $0.01 per share (“Common Stock”). In June 2022, Mast fully converted their November 2021 Note, for which the company issued 4,025,000 shares of Common Stock. Further, during the year ended December 31, 2023, the Company fully converted the balance of Fourth Man convertible note of approximately $127,000 into 1,820,395 shares of the Company’s common stock, which fully retired the convertible note as of September 30, 2024.

 

In March 2022, the Company entered into a Securities Purchase Agreement with Fourth Man, pursuant to which the Company issued convertible promissory note in the aggregate principal amount of $0.25 million, which Note is convertible into shares of the Company’s Common Stock. As of June 30, 2024, this note was in default and available for conversion into the Company’s Common Stock due to cross default provision contained in November / December 2021 Notes. During the nine months ended September 30, 2024, Fourth Man converted a portion of the March 2022 debt, including interest, and conversion fee, of approximately $35,000 for 500,000 shares of the Company’s Common Stock.

 

For more information on the debt financing of the Company, refer to Note 5 of the Notes to the Consolidated Financial Statements.

 

May 2022 Note

 

In May 2022, the Company entered into a Securities Purchase Agreement with Mast, pursuant to which the Company issued convertible promissory notes in the aggregate principal amount of $0.6 million, which note is convertible into shares of the Company’s Common Stock. In May 2024, the May 2022 Note was extended till May 27, 2025, at a cost of 10% of the outstanding Note amount, including interest and penalty. For more information on the debt financing of the Company, refer to Note 5 of the Notes to the Consolidated Financial Statements.

 

June 2022 Note

 

In June 2022, the Company entered into a Securities Purchase Agreement with Blue Lake, pursuant to which the Company issued convertible promissory notes in the aggregate principal amount of $0.34 million, which note was convertible into shares of the Company’s Common Stock. During the nine months ended September 30, 2024, Blue Lake converted the balance of their debt, including accrued interest and penalty, of approximately $531,000 for approximately 7.6 million shares of the Company’s Common Stock.

 

For more information on the debt financing of the Company, refer to Note 5 of the Notes to the Consolidated Financial Statements.

 

10

 

 

Forever Prosperity (previously GMP) Note purchase agreements and unsecured notes

 

Between June 2020 and January 2022, the Company entered into various purchase agreements and promissory notes with GMP, cumulatively totaling $4.5 million. Such notes were assigned to Forever Prosperity, LLC, an affiliated entity of GMP.

 

For more information on the GMP debt financing, refer to Note 5 of the Notes to the Consolidated Financial Statements.

 

Joint Venture with GMP Bio

 

In March 2022, the Company formalized a joint venture (“JV”) with Dragon Overseas Capital Limited (“Dragon”) and GMP Biotechnology Limited (“GMP Bio”), both affiliates of GMP. Although no assurances can be given, the Company and GMP currently intend to conduct an initial public offering of the JV, at a future date, on either the Hong Kong Exchange or other stock exchange.

 

For more information on the JV, refer to Note 6 of the unaudited Notes to the Consolidated Financial Statements.

 

Pet2DAO

 

In November 2022, the Company formed a Decentralized autonomous organization (“DAO”) entity, Pet2DAO LLC (“Pet2DAO”), as a wholly owned subsidiary.

 

For more information on Pet2DAO, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

Mosaic ImmunoEngineering, Inc. Term Sheet

 

In April 2024, the Company entered into a binding term sheet (the “Term Sheet”) with Mosaic ImmunoEngineering, Inc. (“Mosaic”). For more information on the Term Sheet, refer to the Current Report on Form 8-K filed with the SEC on April 29, 2024. In August 2024, Mosaic and the Company mutually agreed to extend the date of the Term Sheet to expire at the earlier of (1) the signing of definitive agreements or (2) December 31, 2024. This was to allow for both Companies to complete due diligence as well as agree and finalize the definitive agreements.

 

Licensing Agreement with Autotelic Inc.

 

In September 2021, the Company entered into an exclusive License Agreement (the “Agreement”) with Autotelic, Inc. (“Autotelic”). For more information on the Agreement, refer to our 2023 10-K filed with the SEC on April 12, 2024.

 

Principles of Consolidation

 

The consolidated financial statements include the accounts of Oncotelic, its wholly owned subsidiaries, Oncotelic Inc. and PointR, and Edgepoint our non-controlled interest entity. Intercompany accounts and transactions have been eliminated in consolidation.

 

Basis of Presentation

 

The accompanying consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission including Form 10-K and Regulation S-X.

 

11

 

 

Liquidity and Going Concern

 

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The Company has incurred net accumulated losses of approximately $37.4 million since inception of Oncotelic Inc., as the Company’s historical financial statements before the Merger have been replaced with the historical financial statements of Oncotelic Inc. The Company also has a negative working capital of approximately $16.1 million at September 30, 2024, of which approximately $2.6 million contingent liability of issuance of common shares of the Company to PointR shareholders upon achievement of certain milestones in accordance with the PointR Merger Agreement. The Company has negative cash flows from operations for the nine months ended September 30, 2024 of approximately $0.6 million. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the date of this filing Management expects to incur significantly lower costs and losses in the foreseeable future, as a majority of the costs related with the development of OT-101 will be incurred by the JV, but the Company also recognizes the need to raise capital to remain viable. The accompanying consolidated financial statements do not include any adjustments that might be necessary should the Company be unable to continue as a going concern.

 

The Company’s long-term plans include continued development of its current pipeline of products, in addition to continue the development of OT-101 which is exclusively out-licensed to the JV and the JV will be responsible for the funding required to support the development in entirety, to generate sufficient revenues, through either technology transfer or product sales, or raise additional financing to cover its anticipated expenses. Until the Company is able to generate sufficient revenues from its current pipeline, the Company plans on funding its operations through the sale of equity and/or the issuance of debt, combined with or without warrants or other equity instruments.

 

The Company obtained short terms loans of approximately $0.6 million from Autotelic Inc., a related party, during the nine months ended September 30, 2024. In addition, the Company obtained a short-term loan of $15 thousand from Amit Shah, it’s CFO during the nine months ended September 30, 2024.

 

Although no assurances can be given as to the Company’s ability to deliver on its revenue plans, or that unforeseen expenses may arise, management believes that the potential equity and debt financing or other potential financing will provide the necessary funding for the Company to continue as a going concern. Also, management cannot guarantee any potential debt or equity financing will be available on favorable terms or at all. As such, management does not believe the Company has sufficient cash for 12 months from the date of this report. If adequate funds are not available on acceptable terms, or at all, the Company will need to curtail operations, or cease operations completely.

 

NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Use of Estimates

 

The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, equity-based transactions and disclosure of contingent liabilities at the date of the financial statements and revenues and expense during the reporting period. Actual results could materially differ from those estimates.

 

The Company believes the following critical accounting policies affect its more significant judgments and estimates used in the preparation of the financial statements. Significant estimates include the valuation of goodwill and intangible assets for impairment, deferred tax asset and valuation allowance, and fair value of financial instruments.

 

Cash

 

As of September 30, 2024, and December 31, 2023 the Company held all its cash in banks. The Company considers investments in highly liquid instruments with a maturity of three months or less to be cash equivalents. The Company did not have any cash equivalents as of September 30, 2024 and December 31, 2023, respectively. Restricted cash consists of certificates of deposits held at banks as collateral.

 

12

 

 

Debt issuance Costs and Debt discount

 

Issuance costs are specific incremental costs that are (1) paid to third parties and (2) directly attributable to the issuance of a debt or equity instrument. The issuance costs attributable to the initial sale of the instrument are offset against the associated proceeds in the determination of the instrument’s initial net carrying amount.

 

Debt issuance costs and debt discounts are being amortized over the lives of the related financings on a basis that approximates the effective interest method. Costs and discounts are presented as a reduction of the related debt in the accompanying balance sheets if related to the issuance of debt or presented as a reduction of additional paid in capital if related to the issuance of an equity instrument. The Company applies the relative fair value to allocate the issuance costs among freestanding instruments that form part of the same transaction.

 

If the Company amends the terms of its convertible notes, the Company reviews and applies the guidance per ASC 470-60 Troubled debt restructurings and ASC 470-50 Debt-Modifications and Extinguishments, evaluates and concludes whether the terms of the agreements were or were not substantially different as of a particular reporting date and accounts the transaction as a debt modification or a troubled debt restructuring.

 

Fair Value of Financial Instruments

 

The carrying value of cash, accounts payable and accrued expense approximate their fair values based on the short-term maturity of these instruments. As defined in ASC 820, “Fair Value Measurements and Disclosures,” fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company utilizes market data or assumptions that market participants would use in pricing the asset or liability, including assumptions about risk and the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market corroborated, or generally unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurement) and the lowest priority to unobservable inputs (level 3 measurement). This fair value measurement framework applies at both initial and subsequent measurement.

 

The three levels of the fair value hierarchy defined by ASC 820 are as follows:

 

Level 1 – Quoted prices are available in active markets for identical assets or liabilities as of the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis. Level 1 primarily consists of financial instruments such as exchange-traded derivatives, marketable securities and listed equities.
   
Level 2 – Pricing inputs are other than quoted prices in active markets included in Level 1, which are either directly or indirectly observable as of the reported date. Level 2 includes those financial instruments that are valued using models or other valuation methodologies. These models are primarily industry-standard models that consider various assumptions, including quoted forward prices for commodities, time value, volatility factors and current market and contractual prices for the underlying instruments, as well as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace throughout the full term of the instrument, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. Instruments in this category generally include non-exchange-traded derivatives such as commodity swaps, interest rate swaps, options and collars.
   
Level 3 – Pricing inputs include significant inputs that are generally less observable from objective sources. These inputs may be used with internally developed methodologies that result in management’s best estimate of fair value.

 

The Company did not have any Level 1 or Level 2 assets and liabilities at September 30, 2024 and December 31, 2023.

 

13

 

 

Investment in equity securities

 

The following table summarizes the cumulative gross unrealized gains and losses and fair values for long-term investments accounted for at fair value under the fair value option, with the unrealized gains and losses reported within earnings on the Condensed Consolidated Statements of Operation as of September 30, 2024 and December 31, 2023:

 

   Initial Book Value  

Cumulative Gross

Unrealized Gains

  

Cumulative Gross

Unrealized Losses

   Fair Value 
September 30, 2024                    
Investment in GMP Bio (equity securities)  $22,653,225   $                  -   $                       -   $22,653,225 
Total  $22,653,225   $-   $-   $22,653,225 

 

   Initial Book Value  

Cumulative Gross

Unrealized Gains

  

Cumulative Gross

Unrealized Losses

   Fair Value 
December 31, 2023                    
Investment in GMP Bio (equity securities)  $22,640,521   $12,704   $                       -   $22,653,225 
Total  $22,640,521   $12,704   $-   $22,653,225 

 

The table above sets forth a summary of the recording of the initial value of the long-term value of investment in equity securities of GMP Bio, based on a third-party valuation report, and changes in the fair value of such equity securities, if such change occurs, as a Level 3 fair value as of September 30, 2024 and December 31, 2023. During the nine months ended September 30, 2024, there have been no changes in the long-term value of the investment in equity securities of GMP Bio.

 

Derivative Liability

 

The Company has certain derivative liabilities associated with its 2019 bridge financing Convertible Notes (see Note 5), which consisted of conversion feature derivatives at September 30, 2024 and December 31, 2023, are Level 3 fair value measurements.

 

The table below sets forth a summary of the changes in the fair value of the Company’s derivative liabilities classified as Level 3 as of September 30, 2024 and December 31, 2023:

 

  

September 30, 2024

Conversion Feature

  

December 31, 2023

Conversion Feature

 
Balance at January 1, 2024 and 2023  $423,214   $198,140 
New derivative liability   -    - 
Reclassification to additional paid in capital from conversion of debt to common stock   -    - 
Change in fair value   (140,828)   225,074 
           
Balance at September 30, 2024 and December 31, 2023  $282,386   $423,214 

 

14

 

 

As of September 30, 2024, and December 31, 2023, the Company estimated the fair value of the conversion feature derivatives embedded in the convertible debentures based on assumptions used in the Black-Scholes valuation model. The key valuation assumptions used consists, in part, of the price of the Company’s Common Stock, a risk-free interest rate based on the yield of a Treasury note and expected volatility of the Company’s Common Stock all as of the measurement dates. The Company used the following assumptions to estimate fair value of the derivatives as of September 30, 2024 and December 31, 2023, respectively:

 

   September 30, 2024   December 31, 2023 
   Key   Key 
   Assumptions   Assumptions 
   for fair value   for fair value 
   of conversions   of conversions 
Risk free interest   3.98% - 5.09 %   4.64% - 5.40%
Market price of share  $0.02 - 0.04   $0.03 - 0.05 
Life of instrument in years   0.01    0.01 
Volatility   161.5% - 226.9%   142.45%-236.86%
Dividend yield   0%   0%

 

When the Company changes its valuation inputs for measuring financial liabilities at fair value, either due to changes in current market conditions or other factors, it may need to transfer those liabilities to another level in the hierarchy based on the new inputs used. The Company recognizes these transfers at the end of the reporting period that the transfers occur. For the periods ended September 30, 2024 and 2023, respectively, there were no transfers of financial assets or financial liabilities between the hierarchy levels.

 

The $2,625,000 of contingent consideration, of shares issuable to PointR shareholders which was recorded and associated with the PointR Merger, is also classified as Level 3 fair value measurements. The Company initially recorded the contingency based on a valuation conducted by a third-party valuation expert. The valuation was based on a probability of the completion of certain milestones by PointR for the shareholders to earn additional shares. The Company evaluated the probability of the earning of the milestones and concluded that the probability of achievement of the milestones had not changed, primarily due to the shifting of focus by the Company to develop AI technologies for the COVID-19 pandemic as well as other AI technologies. As such, the Company did not record any change to the valuation during the nine months ended September 30, 2024 or 2023, respectively.

 

Net Income (Loss) Per Share

 

Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share includes the effect of Common Stock equivalents (notes convertible into Common Stock, stock options and warrants) when, under either the treasury or if-converted method, such inclusion in the computation would be dilutive. For the three and nine months ended September 30, 2024 and 2023, no equivalent shares of the Common Stock were excluded as the company has a loss and addition of such stock equivalents in the computation would have been anti-dilutive.

 

Stock-Based Compensation

 

The Company applies the provisions of ASC 718, Compensation—Stock Compensation (“ASC 718”), which requires the measurement and recognition of compensation expense for all stock-based awards made to employees, including employee stock options, in the statements of operations.

 

For stock options issued to employees and members of the Board of Directors (the “Board”) for their services, the Company estimates the grant date fair value of each option using the Black-Scholes option pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock. For awards subject to service-based vesting conditions, including those with a graded vesting schedule, the Company recognizes stock-based compensation expense equal to the grant date fair value of stock options on a straight-line basis over the requisite service period, which is generally the vesting term. Forfeitures are recorded as they are incurred as opposed to being estimated at the time of grant and revised.

 

15

 

 

For warrants issued in connection with fund raising activities, the Company estimates the grant date fair value of each warrant using the Black-Scholes pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the warrant, the expected volatility of the Common Stock consistent with the expected life of the warrant, risk-free interest rates and expected dividend yields of the Common Stock. If the warrants are issued upon termination or cancellation of prior issued warrants, then the Company estimates the grant date fair value of the new warrants using the Black-Scholes pricing model and evaluates whether the new warrants are deemed as equity instruments or liability instruments. If the warrants are deemed to be equity instruments, the Company records stock compensation expense and an addition to additional paid in capital. If, however, the warrants are deemed to be liability instruments, then the fair value is treated as a deemed dividend and credited to additional paid in capital.

 

Impairment of Long-Lived Assets

 

The Company reviews long-lived assets, including definite-lived intangible assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of these assets is determined by comparing the forecasted undiscounted net cash flows of the operation to which the assets relate to the carrying amount. If the operation is determined to be unable to recover the carrying amount of its assets, then these assets are written down first, followed by other long-lived assets of the operation to fair value. Fair value is determined based on discounted cash flows or appraised values, depending on the nature of the assets. For the three and nine months ended September 30, 2024 and 2023, respectively, there were no impairment losses recognized for long-lived assets.

 

Intangible Assets

 

The Company records its intangible assets at cost in accordance with ASC 350, Intangibles – Goodwill and Other. The Company reviews the intangible assets for impairment on an annual basis or if events or changes in circumstances indicate it is more likely than not that they are impaired. These events could include a significant change in the business climate, legal factors, a decline in operating performance, competition, sale or disposition of a significant portion of the business, or other factors. If the review indicates the impairment, an impairment loss would be recorded for the difference of the value recorded and the new value. For the nine months ended September 30, 2024 and September 30, 2023, there were no impairment losses recognized for intangible assets. When we sell or contribute properties to unconsolidated arrangements and retain a non-controlling ownership interest in such assets, we recognize the difference between the consideration received and the carrying amount of the asset sold or contributed.

 

Goodwill

 

Goodwill represents the excess of the purchase price of acquired business over the estimated fair value of the identifiable net assets acquired. Goodwill is not amortized but is tested for impairment at least once annually, at the reporting unit level or more frequently if events or changes in circumstances indicate that the asset might be impaired. The goodwill impairment test is applied by performing a qualitative assessment before calculating the fair value of the reporting unit. If, on the basis of qualitative factors, it is considered not more likely than not that the fair value of the reporting unit is less than the carrying amount, further testing of goodwill for impairment would not be required. Otherwise, goodwill impairment is tested using a two-step approach.

 

The first step involves comparing the fair value of the reporting unit to its carrying amount. If the fair value of the reporting unit is determined to be greater than its carrying amount, there is no impairment. If the reporting unit’s carrying amount is determined to be greater than the fair value, the second step must be completed to measure the amount of impairment, if any. The second step involves calculating the implied fair value of goodwill by deducting the fair value of all tangible and intangible assets, excluding goodwill, of the reporting unit from the fair value of the reporting unit as determined in step one. The implied fair value of the goodwill in this step is compared to the carrying value of goodwill. If the implied fair value of the goodwill is less than the carrying value of the goodwill, an impairment loss equivalent to the difference is recorded. For the three and nine months ended September 30, 2024, we recorded an impairment loss of approximately $3 million on our goodwill. For the three and nine months ended September 30, 2023, we recorded an impairment loss of approximately $0 and $6.1 million, respectively, based on the difference between the carrying value of our goodwill as against the market capitalization of the Company. For more information on goodwill and impairment, refer to Note 3 to these Notes to the Consolidated Financial Statements.

 

16

 

 

Derivative Financial Instruments Indexed to the Company’s Common Stock

 

We have generally issued derivative financial instruments, such as warrants, in connection with our equity offerings. We evaluate the terms of these derivative financial instruments in order to determine their accounting treatment in our financial statements. Key considerations include whether the financial instruments are freestanding and whether they contain conditional obligations. If the warrants are freestanding, do not contain conditional obligations and meet other classification criteria, we account for the warrants as an equity instrument. However, if the warrants contain conditional obligations, then we account for the warrants as a liability until the conditional obligations are met or are no longer relevant. Because no established market prices exist for the warrants that we issue in connection with our equity offerings, we must estimate the fair value of the warrants based on the price of our Common Stock as of December 31 each year, which is as inherently subjective as it is for stock options, and for similar reasons as noted in the stock-based compensation section above. For financial instruments which are accounted for as a liability, we report any changes in their estimated fair values as gains or losses in our Consolidated Statement of Income.

 

Convertible Instruments

 

The Company evaluates and accounts for conversion options embedded in its convertible instruments in accordance with ASC 815 “Derivatives and Hedging”.

 

ASC 815 generally provides three criteria that, if met, require companies to bifurcate conversion options from their host instruments and account for them as free-standing derivative financial instruments. These three criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur, and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. Professional standards also provide an exception to this rule when the host instrument is deemed to be conventional as defined under professional standards as “The Meaning of Conventional Convertible Debt Instrument.”

 

The Company accounts for convertible instruments (when it has determined that the embedded conversion options should not be bifurcated from their host instruments) in accordance with ASC 470-20 “Debt – Debt with Conversion and Other Options.” Accordingly, the Company records, when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments based upon the differences between the fair value of the underlying Common Stock at the commitment date of the note transaction and the effective conversion price embedded in the note. Original issue discounts (“OID”) under these arrangements are amortized over the term of the related debt to their earliest date of redemption. The Company also records when necessary deemed dividends for the intrinsic value of conversion options embedded in preferred shares based upon the differences between the fair value of the underlying Common Stock at the commitment date of the note transaction and the effective conversion price embedded in the note.

 

ASC 815-40 “Derivatives and Hedging – Contracts in Entity’s Own Equity” provides that, among other things, generally, if an event is not within the entity’s control could or require net cash settlement, then the contract shall be classified as an asset or a liability.

 

17

 

 

Variable Interest Entity (VIE) Accounting

 

The Company evaluates its ownership, contractual relationships and other interests in entities to determine the nature and extent of the interests, whether such interests are variable interests and whether the entities are VIEs in accordance with ASC 810, Consolidations. These evaluations can be complex and involve Management judgment as well as the use of estimates and assumptions based on available historical information, among other factors. Based on these evaluations, if the Company determines that it is the primary beneficiary of a VIE, the entity is consolidated into the financial statements. At September 30, 2024 and September 30, 2023, the Company identified EdgePoint to be the Company’s sole VIE. At September 30, 2024 and September 30, 2023, the Company’s ownership percentage of EdgePoint was 29% and 29%, respectively. The VIE’s net assets were less than $0.1 million at September 30, 2024 and December 31, 2023, respectively.

 

Investments - Equity Method

 

The Company accounts for equity method investments at cost, adjusted for the Company’s share of the investee’s earnings or losses, which are reflected in the consolidated statements of operations. The Company periodically reviews the investments for other than temporary declines in fair value below cost and more frequently when events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. The Investment in GMP Bio represents the investment into equity securities for which the Company elected the fair value option pursuant to ASC 825-10-15 and subsequent fair value changes in the GMP Bio shares shall be included in the result from other income. Refer to Note 6 to these Notes to the Consolidated Financial Statements.

 

Joint Venture agreement

 

We have equity interest in unconsolidated arrangement that is primarily engaged in the business of drug discovery, development, and commercialization, including but not limited to development and commercialization of TGF-beta therapeutics as well as establishing and operating contract development and manufacturing organization (“CDMO”) facilities and capabilities. The Company first reviews the arrangement to determine if it meets the definition of an accounting joint venture pursuant to ASC 323-10-20. In order to meet the definition of a joint venture, the arrangement must have all of the following characteristics, (i) the arrangement is organized within a separate legal entity, (ii) the entity is under the joint control of the venturers, (iii) the venturers must be able to exercise joint control through their equity investments, (iv) the qualitative characteristics of the entity, including its purpose and design must be consistent with the definition of a joint venture.

 

We consolidate arrangements that are considered to be VIEs where we are the primary beneficiary. We analyze our investments in joint ventures to determine if the joint venture is considered a VIE and would require consolidation. We (i) evaluate the sufficiency of the total equity investment at risk, (ii) review the voting rights and decision-making authority of the equity investment holders as a group and whether there are limited partners (or similar owning entities) that lack substantive participating or kick out rights, guaranteed returns, protection against losses, or capping of residual returns within the group and (iii) establish whether activities within the venture are on behalf of an investor with disproportionately few voting rights in making this VIE determination.

 

To the extent that we own interests in a VIE and we (i) have the power to direct the activities that most significantly impact the economic performance of the VIE and (ii) have the obligation or rights to absorb losses or receive benefits that could potentially be significant to the VIE, then we would be determined to be the primary beneficiary and would consolidate the VIE. To the extent that we own interests in a VIE, then at each reporting period, we re-assess our conclusions as to which, if any, party within the VIE is considered the primary beneficiary.

 

To the extent that our arrangements do not qualify as VIEs, they are consolidated if we control them through majority ownership interests or if we are the managing entity (general partner or managing member) and our partner does not have substantive participating rights. Control is further demonstrated by our ability to unilaterally make significant operating decisions, refinance debt, and sell the assets of the joint venture without the consent of the non-managing entity and the inability of the non-managing entity to remove us from our role as the managing entity.

 

We use the equity method of accounting for those arrangements where we exercise significant influence but do not have control. Under the equity method of accounting, our investment in each arrangement is included on our consolidated balance sheet; however, the assets and liabilities of the joint ventures for which we use the equity method are not included on our consolidated balance sheet.

 

18

 

 

When we sell or contribute properties to unconsolidated arrangements and retain a non-controlling ownership interest in such assets, we recognize the difference between the consideration received and the carrying amount of the asset sold or contributed when its derecognition criteria are met. The equity method investment we retain in such partial sale transactions is noncash consideration and is measured at fair value. As a result, the accounting for a partial sale will result in the recognition of a full gain or loss.

 

When circumstances indicate there may have been a reduction in the value of an equity investment, we evaluate whether the loss in value is other than temporary. If we conclude it is other than temporary, we recognize an impairment charge to reflect the equity investment at fair value.

 

The Company elected the fair value option under the fair value option Subsection of Section 825-10-15 to account for its equity-method investment as the Company believes that the fair value option is most appropriate for a company in the biotechnology industry, The fair value option is more appropriate for companies that are involved in extensive and usually very expensive research and development efforts, which are not appropriately reflected in the market value or reflective of the true value of the development activities of the company.

 

Embedded debt costs in convertible debt instruments

 

In August 2020, the FASB issued “ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40)” (“ASU 2020-06”) which simplifies the accounting for convertible instruments. The guidance removes certain accounting models which separate the embedded conversion features from the host contract for convertible instruments. Either a modified retrospective method of transition or a fully retrospective method of transition was permissible for the adoption of this standard. Update No. 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption was permitted no earlier than the fiscal year beginning after December 15, 2020. The Company adopted ASU 2020-06 effective January 1, 2023 and has removed the effects of any embedded conversion features from certain of our convertible instruments as of that date.

 

Revenue Recognition

 

The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers (Topic 606).

 

Under Topic 606, the Company recognizes revenue when its customers obtain control of the promised good or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. The Company applies the following five-step: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation.

 

At contract inception, once the contract is determined to be within the scope of Topic 606, the Company identifies the performance obligation(s) in the contract by assessing whether the goods or services promised within each contract are distinct. The Company then recognizes revenue for the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

 

The Company anticipates generating revenues from rendering services to other third-party customers for the development of certain drug products and/or in connection with certain out-licensing agreements. In the case of services rendered for development of the drugs, revenue is recognized upon the achievement of the performance obligations or over time on a straight-line basis over the extended service period. In the case of out-licensing contracts, the Company records revenues either upon achievement of certain pre-defined milestones, when there is no obligation of the Company achieve any performance obligations in connection with the said pre-defined milestones, or upon achievement of the performance obligations if the milestones require the Company to provide the performance obligations.

 

The Company occasionally collects advance payments from customers toward commitments to provide services or performance obligations, in which case the advance payment is recorded as a liability until the obligations are fulfilled and revenue is recognized.

 

19

 

 

Research & Development Costs

 

In accordance with ASC 730-10-25 “Research and Development”, research and development costs are charged to expense as and when incurred.

 

Recent Accounting Pronouncements

 

In August 2020, the FASB issued “ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40)” (“ASU 2020-06”) which simplifies the accounting for convertible instruments. The guidance removes certain accounting models which separate the embedded conversion features from the host contract for convertible instruments. Either a modified retrospective method of transition or a fully retrospective method of transition was permissible for the adoption of this standard. Update No. 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption was permitted no earlier than the fiscal year beginning after December 15, 2020. The Company adopted ASU 2020-06 effective January 1, 2023 and recorded approximately $0.5 million as a reduction to the additional paid in capital and added approximately $0.3 million to the opening retained earnings in accordance with the authoritative guidance under ASU 2020-06.

 

All other newly issued but not yet effective accounting pronouncements have been deemed to be not applicable or immaterial to the Company.

 

NOTE 3 - INTANGIBLE ASSETS AND GOODWILL

 

Goodwill from 2019 Reverse Merger with Oncotelic and PointR

 

The Company completed the reverse merger with Oncotelic Inc. (“Merger”) in April 2019. The Company completed the merger with PointR Data Inc (“PointR Merger”) in November 2019. For more details on the two mergers, refer to our 2020 Annual Report on Form 10-K for the year ended December 31, 2020 filed by the Company on April 15, 2021.

 

The Oncotelic merger gave rise to Goodwill of approximately $4.9 million. Upon the non-financial sale of our asset as contribution to our equity method investment, we derecognized the balance of the carrying value of our goodwill of approximately $4.9 million from the Oncotelic Merger in accordance with our policy and authoritative accounting guidance.

 

Further, we added goodwill of $16,182,456 upon the completion of the Merger with PointR.

 

We have one operating segment and reporting unit. Accordingly, our review of goodwill impairment indicators was performed at the entity-wide level. In performing our annual impairment assessment, we determined if we should qualitatively assess whether it was more likely than not the fair value of goodwill was less than its carrying amount (the qualitative impairment test). The factors we considered in the assessment included our market capitalization, general macroeconomic conditions, conditions specific to the industry and market and whether there had been sustained declines in our share price. If we concluded, it was more likely than not, the fair value of the reporting unit was less than its carrying amount, or elected not to use the qualitative impairment test, a quantitative impairment test would be performed.

 

We used our market capitalization as an indicator of fair value. While we believe the fair value measurement need not be based solely on the quoted market price of an individual share of our Common Stock, and that we also could consider the impact of a control premium in measuring the fair value of its reporting unit. In the absence of any other valuation metrics, the Company believed using a control premium utilized would not be appropriate under the current circumstances. We also considered some other market comparables’ trends in our stock price as well as the industry over a period of two successive quarters and prospective quarter to evaluate whether the fair value of our reporting unit was greater than our carrying amount. As such, we performed a quantitative impairment assessment of goodwill for our single reporting unit at the end of 2023, due to a sustained decline in our market capitalization and an increase in negative economic outlook for biotech markets We estimated and reconciled the fair value of our reporting unit utilizing our market capitalization based on the stock price of our Common Stock as of December 31, 2023. Before completing our goodwill impairment test, we first tested our indefinite-lived intangible asset then our remaining long-lived assets for impairment. We concluded our indefinite-lived intangible assets were not impaired. Based on the market capitalization, we further concluded the fair value of our single reporting unit was less than its carrying value and therefore recognized an impairment charge of $6.1 million during the year ended December 31, 2023. The calculation of the impairment charge included substantial fact-based determinations and estimates. The Company evaluated if it needed to record any additional goodwill impairment as of September 30, 2024, based solely on the market capitalization of the Company and concluded that an additional impairment of approximately $3.2 million was required to be recorded for the nine months ended September 30, 2024.

 

20

 

 

A summary of our goodwill as of September 30, 2024 and December 31, 2023 is shown below:

 

  

September 30,

2024

  

December 31,

2023

 
Balance at January 1, 2024 and 2023  $5,988,230   $12,071,376 
Less: Goodwill impairment due to market capitalization   (3,200,000)   (6,083,146)
           
Balance at September 30, 2024 and December 31, 2023  $2,788,230   $5,988,230 

 

In general, the goodwill is tested on an annual impairment date of December 31, unless we observe any further deterioration in our market capitalization in any interim periods, in which case we may, depending on the materiality of the impairment, record an impairment at the end of other reporting periods, as we did during the course of the year ended December 31, 2023.

 

In-Process Research & Development (“IPR&D”) Summary

 

The IPR&D assets were acquired in the PointR Merger during the year ended December 31, 2019. Since January 2021, the Company has determined that the IPR&D should be reported as an indefinitely lived asset and therefore will evaluate, on an annual basis, for any impairment on the IPR&D and will record an impairment if identified. The balance of IPR&D as of September 31, 2024 and December 31, 2023, respectively, was $1,101,760. For more information on the IPR&D, please refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

NOTE 4 – ACCOUNTS PAYABLE AND ACCRUED EXPENSES

 

Accounts payable and accrued expense consists of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
         
Accounts payable  $1,692,263   $1,656,613 
Accrued expense   769,860    780,708 
Accounts payable and accrued liabilities  $2,462,123   $2,437,321 

 

  

September 30,

2024

  

December 31,

2023

 
           
Accounts payable – related party  $345,543   $344,099 

 

21

 

 

NOTE 5 – CONVERTIBLE DEBENTURES, NOTES AND OTHER DEBT

 

As of September 30, 2024 and December 31, 2023, special purchase agreements (SPAs) with convertible debentures and notes, net of debt discount and including accrued interest, if any, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
Current Debt          
Convertible debentures          
10% Convertible note payable – Bridge Investor  $35,556   $35,556 
10% Convertible note payable – Related Party   164,444    164,444 
10% Convertible note payable – Bridge Investor   200,000    200,000 
Convertible note payable   400,000    400,000 
Fall 2019 Notes          
5% Convertible note payable – Stephen Boesch   132,708    128,958 
5% Convertible note payable – Related Party   310,608    301,233 
5% Convertible note payable – Dr. Sanjay Jha (Through his family trust)   310,128    300,753 
5% Convertible note payable – CEO & CFO – Related Parties   101,634    98,559 
5% Convertible note payable – Bridge Investors   208,222    201,922 
Convertible note payable   1,063,300    1,031,425 
August 2021 Convertible Notes          
5% Convertible note – Autotelic Inc– Related Party   289,427    280,052 
5% Convertible note – Bridge investors   432,406    418,399 
5% Convertible note – CFO – Related Party   86,832    84,018 
 Convertible note payable    808,665    782,469 
JH Darbie PPM Debt          
16% Convertible Notes – Non-related parties   -    311,693 
16% Convertible Notes – CEO – Related Party   -    - 
Convertible note payable   -    311,693 
           
November/December 2021 & March 2022 Notes          
16% Convertible Notes – Accredited Investors   225,296    233,393 
           
Debt for Clinical Trials – Forever Prosperity ( Formerly GMP)          
2% Convertible Notes – Forever Prosperity   4,817,562    4,750,000 
           
May 2022 Note          
16% Convertible Notes – Accredited Investors   972,500    1,401,283 
           
Other Debt          
Short term debt – Bridge investors   210,000    210,000 
Short term debt from CFO – Related Party   50,050    35,050 
Short term debt – Autotelic Inc. – Related Party   2,070,000    1,470,000 
Short Term Debt from CEO – Related Party   50,000    50,000 
 Short term debt    2,380,050    1,765,050 
Total of short term convertible debentures & notes and other debt  $10,667,373    10,675,313 

 

  

September 30,

2024

  

December 31,

2023

 
Long Term Debt          
JH Darbie PPM 2 Debt          
16% Convertible Notes - Non-related parties   2,142,849    1,773,468 
16% Convertible Notes – CEO – Related Party   125,000    125,000 
 Convertible note payable    2,267,849    1,898,468 

 

22

 

 

Convertible Debentures

 

As of September 30, 2024, the Company had a derivative liability of approximately $282,000 and recorded a change in fair value of approximately $140,000 on the Convertible Debentures issued in 2019 to our CEO and a bridge investor.

 

Bridge Financing

 

Notes with Officer and Bridge Investor

 

In April 2019, the Company entered into a Securities Purchase Agreement (the “Bridge SPA”) with our CEO (the “Trieu Note”) and a Bridge Investor with a commitment to purchase convertible notes in the aggregate of $400,000. For more information on the Bridge SPA, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

The issuance of the Trieu Note resulted in a discount from the beneficial conversion feature totaling $131,555 related to the conversion feature. Total amortization of the OID and the discount totaled approximately $0 for the nine months ended September 30, 2024 and 2023, respectively. Total unamortized discount on this note was approximately $0 as of September 30, 2024, and December 31, 2023, respectively.

 

In April 2019, pursuant to the Bridge SPA the Company entered into Convertible Note Tranche #1 (“Tranche #1”) with the Bridge Investor. For more information on Tranche #1, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

The issuance of the note resulted in a discount from the beneficial conversion feature totaling $28,445. Total amortization of the OID and discount totaled approximately $0 for the nine months ended September 30, 2024, and 2023, respectively. Total unamortized discount on this note was approximately $0 as of September 30, 2024, and December 31, 2023.

 

In August 2019, pursuant to the Bridge SPA the Company entered into Convertible Note Tranche #2 (“Tranche #2”) with the Bridge Investor. For more information on Tranche #2, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

The issuance of the note resulted in a discount from the beneficial conversion feature totaling $175,000. Total amortization of the OID and discount totaled approximately $0 for the nine months ended September 30, 2024, and 2023, respectively. Total unamortized discount on this note was $0 as of September 30, 2024, and December 31, 2023.

 

Fall 2019 Debt Financing

 

Between November and December 2019, the Company closed its Fall 2019 Debt Financing and entered into certain Note Purchase Agreements (the “Fall 2019 Note Purchase Agreements”) with certain accredited investors and the officers of the Company for the sale of convertible promissory notes (the “Fall 2019 Notes”). The Company issued Fall 2019 Notes in the principal amount of $250,000 to each of Dr. Vuong Trieu, the Company’s Chief Executive Officer, and Stephen Boesch, in exchange for gross proceeds of $500,000. Further, the Company issued Fall 2019 Notes to additional investors including $250,000 to Dr. Sanjay Jha, through his family trust, the former CEO of Motorola and COO/President of Qualcomm. The Company also offset certain amounts due to Dr. Vuong Trieu, the Company’s Chief Executive Officer, Chulho Park, the Company’s then Chief Technology Officer, and Amit Shah, the Company’s Chief Financial Officer, all related parties as Officers of the Company, and converted such amounts due into the Fall 2019 Notes. $35,000 due to Dr. Vuong Trieu, $27,000 due to Chulho Park and $20,000 due to Amit Shah were converted into convertible debt under the Fall 2019 Notes. The Company also issued the Fall 2019 Notes of $168,000 to two accredited investors.

 

All the Fall 2019 Notes provided for interest at the rate of 5% per annum and are unsecured. For more information on the Fall 2019 Debt Financing, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

23

 

 

There was no activity during the nine months ended September 30, 2024 and 2023. The total unamortized principal amount of the Fall 2019 Notes was $850,000 as of September 30, 2024, and December 31, 2023.

 

Further, the Company recorded interest expense of $10,600 and $32,000 on these Fall 2019 Notes for the three and nine months ended September 30, 2024 and September 30, 2023, respectively. The total amount outstanding under the Fall 2019 Notes, net of discounts and including accrued interest thereon, as of September 30, 2024 and December 31, 2023, was $1,063,300 and $1,031,425, respectively.

 

GMP Notes

 

In June 2020, the Company secured $2 million in debt financing, evidenced by a one-year convertible note (the “GMP Note”) from GMP, to conduct a clinical trial evaluating OT-101 against COVID-19 bearing 2% annual interest, and is personally guaranteed by Dr. Vuong Trieu, the Chief Executive Officer of the Company. The GMP Note is convertible into the Company’s Common Stock upon the GMP Note’s maturity of the GMP Note, at the Company’s Common Stock price on the date of conversion with no discount. GMP has waived the default in the maturity of the GMP Note and as such there is no event of default and also agreed to extend the date of maturity of the GMP Note to December 31, 2024. GMP does not have the option to convert prior to the GMP Note’s maturity. Such financing will be utilized solely to fund the clinical trial. The Company’s liability under GMP Note commenced to accrue when GMP first began to pay for services related to the clinical trial to our third-party clinical research organization, up to a maximum of $2 million. GMP has been invoiced by the clinical research organization for the full $2 million as of September 30, 2024, and as such the Company has recognized the liability as a convertible debt.

 

In September 2021, the Company secured a further $1.5 million in debt financing, evidenced by a one-year convertible note (the “GMP Note 2”) from GMP, to fund the same clinical trial evaluating OT-101 against COVID-19 bearing 2% annual interest. The GMP Note is convertible into the Company’s Common Stock upon the GMP Note 2’s maturity one year from the date of the GMP Note 2, at the Company’s Common Stock price on the date of conversion with no discount. GMP has waived the default in the maturity of the GMP Note and as such there is no event of default and also agreed to extend the date of maturity of the GMP Note to December 31, 2024. GMP does not have the option to convert prior to the GMP Note 2’s maturity at the end of one year. Such financing was to be utilized solely to fund the clinical trial. As of September 30, 2024, GMP was invoiced by the clinical research organization for $1.5 million. Till date, GMP paid the clinical trial organization the $1.0 million.

 

In October 2021, the Company entered into an Unsecured Convertible Note Purchase Agreement (the “October Purchase Agreement”) with GMP, pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of $0.5 million (the “October 2021 Note”), which October 2021 Note is convertible into shares of the Company’s Common Stock. GMP has waived the default in the maturity of the GMP Note and as such there is no event of default and also agreed to extend the date of maturity of the GMP Note to December 31, 2024.

 

In January 2022, the Company entered into an Unsecured Convertible Note Purchase Agreement (the “January Purchase Agreement”) with GMP, pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of $0.5 million (the “January 2022 Note”), which January 2022 Note is convertible into shares of the Company’s Common Stock. GMP agreed to extend the date of maturity of the January 2022 Note to December 31, 2024.

 

Cumulatively, the GMP Note, GMP Note 2, October 2021 Note and the January 2022 Notes are referred to as the “GMP Notes”. The GMP Notes carry an interest rate of 2% per annum and mature on the earlier of (a) the one- year anniversary of the date of the Purchase Agreement, or (b) the acceleration of the maturity by GMP upon occurrence of an Event of Default (as defined below). All Notes contain a voluntary conversion mechanism whereby GMP may convert the outstanding principal and accrued interest under the terms of all the GMP Notes into shares of Common Stock (the “Conversion Shares”), at the consolidated closing bid price of the Company’s Common Stock on the applicable OTC Market as of the date the Company receives a Notice of Conversion from GMP. Prepayment of the GMP Notes may be made at any time by payment of the outstanding principal amount plus accrued and unpaid interest. The October Note contains customary events of default (each an “Event of Default”). If an Event of Default occurs, at GMP’s election, the outstanding principal amount of the GMP Notes, plus accrued but unpaid interest, will become immediately due and payable in cash. The October Purchase Agreement requires the Company to use of the proceeds received under the October 2021 Note to support the clinical development of OT-101, including payroll and has been made in continuation of the relationship between the Company and GMP. All the GMP notes were assigned to Forever Prosperity, LLC, an affiliated entity of GMP. The total principal outstanding on all the GMP notes, inclusive of accrued interest, was approximately $4.81 million and $4.75 million, both as of September 30, 2024 and December 31, 2023, respectively. During the three and nine months ended September 30, 2024, and 2023, the Company incurred approximately $22,700 and $67,500 of interest expense, respectively.

 

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August 2021 Notes

 

In August 2021, the Company entered into Note Purchase Agreements with Autotelic - a related party, our CFO – a related party, and certain accredited investors (the “August 2021 investors”), whereby the Company issued four convertible notes in the aggregate principal amount of $698,500 convertible into shares of common stock of the Company for net proceeds of approximately $691,000. The convertible notes carry a five (5%) percent coupon and mature one year from issuance. The majority of the August 2021 investors have the right, but not the obligation, not more than five days following the maturity date, to convert all, but not less than all, the outstanding and unpaid principal plus accrued interest into the Company’s common stock, at a conversion price of $0.18. The August 2021 Note Holders has waived the default in the maturity of the August 2021 Notes and as such there is no event of default and also agreed to extend the date of maturity of the August 2021 Notes to December 31, 2024. The Company determined that the economic characteristics and risks of the embedded conversion option are not clearly and closely related to the economic characteristics and risks of the debt host instrument. Further, the Company determined that the embedded conversion feature meets the definition of a derivative but met the scope exception to the derivative accounting required under ASC 815 for certain contracts involving a reporting entity’s own equity.

 

As of September 30, 2024, and December 31, 2023, the August 2021 convertible notes, inclusive of accrued interest, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
Autotelic Related party convertible note, 5% coupon December 2023  $289,427   $280,052 
Accredited investors convertible note, 5% coupon December 2023   432,406    418,399 
CFO Related party convertible note, 5% coupon December 2023   86,832    84,018 
Convertible notes  $808,665   $782,469 

 

During the three and nine months ended September 30, 2024, the Company recognized approximately $8,730 and $26,200 of interest expense on the August 2021 Investors notes of which approximately $4,060 and $12,190 are attributable to related parties.

 

At September 30, 2024 and December 31, 2023, accrued interests on these convertible notes totaled approximately $110,000 and $84,000, respectively.

 

November – December 2021 and March 2022 Financing

 

In November / December 2021, the Company entered into securities purchase agreement with five institutional investors, whereby the Company issued five convertible notes in the aggregate principal amount of $1,250,000 convertible into shares of common stock of the Company. The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from issuance or upon event of default. Investors has the right at any time following issuance date to convert all or any part of the outstanding and unpaid amount of the note into the Company’s common stock at a conversion price established at a fixed rate of $0.07. The Company granted a total number of 9,615,385 warrants convertible into an equivalent number of the Company Common Stock at a strike price of $0.13 up to five years after issuance. The Placement agent was also granted a total of 961,540 warrants convertible into an equivalent number of the Company Common Stock at a strike price of $0.13 up to five years after issuance, as part of a finder’s fee agreement.

 

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Further, in March 2022, the Company entered into a Securities Purchase Agreement with Fourth Man, pursuant to which the Company issued convertible promissory note in the aggregate principal amount of $0.25 million, convertible into shares of common stock of the Company. The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from issuance or upon event of default. As of December 31, 2022, this note is in Investors have the right at any time following issuance date to convert all or any part of the outstanding and unpaid amount of the note into the Company’s Common Stock at a conversion price established at a fixed rate of $0.10. The Company granted a total number of 1,250,000 warrants convertible into an equivalent number of the Company common shares at a strike price of $0.20 up to five years after issuance. The Placement agent was also granted a total of 125,000 warrants convertible into an equivalent number of the Company Common Stock at a strike price of $0.20 up to five years after issuance, as part of a finder’s fee agreement.

 

As of September 30, 2024, all of the November- December 2021 notes and any accrued interest, are fully converted.

 

As of September 30, 2024, and December 31, 2023, the March 2022 Fourth Man convertible note, including accrued interest and net of debt discount, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
         
Fourth Man Convertible note, 16% coupon March 2023 inclusive of accrued interest and default provision  $225,296   $233,393 
Unamortized debt discount   -    - 
Convertible notes, net  $225,296    233,393 

 

In February 2024, the Company converted approximately $35,000 in principal, accrued interest and legal fees into 500,000 shares of common stock. The note includes a default amount calculated at 125% of the unpaid principal and accrued interest. The Company recognized approximately $8,400 and $25,500 of interest during the three and nine months ended September 30, 2024. Similarly, the Company recognized approximately $8,400 and $23,000 of interest during the three and nine months ended September 30, 2023. As of September 30, 2024, the Fourth Man note was in technical default as the Company failed to repay the principal at the maturity date. However, the Company has not received notification of default from the lender. The default provision requires the accrual of a default penalty of 25% of the outstanding principal plus accrued interest. The Company has recorded an estimated default penalty of approximately $70,000. As of September 30, 2024 and December 31, 2023, the balance of the unamortized debt discount was $0. The Company adopted ASU 2020-06 on January 1, 2023, which resulted in the reversal of the original BCF amount to additional paid in capital for $109,349, reversal of the unamortized debt discount related to the BCF for $25,489 with the balance being recorded through retained earnings for $78,460.

 

May 2022 Mast Financing

 

In May 2022, the Company entered into a securities purchase agreement with one institutional investor, whereby the Company issued one convertible note in the aggregate principal amount of $605,000 convertible into shares of common stock of the Company (“May 2022 Mast Note”). The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from issuance or upon event of default. Investor has the right at any time following issuance date to convert all or any part of the outstanding and unpaid amount of the note into the Company’s common stock at a conversion price established at a fixed rate of $0.10. The Company granted a total number of 3,025,000 warrants convertible into an equivalent number of the Company common shares at a strike price of $0.20 up to five years after issuance. The Placement agent was also granted a total amount of 302,500 as part of a finder’s fee agreement. Portion of the proceeds were be used to retire some of the November/December 2021 notes.

 

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As of September 30, 2024, and December 31, 2023, the May 2022 Mast Financing, net of debt discount, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
Mast Hill Convertible note, 12% coupon May 2023, inclusive of accrued interest and penalty  $972,500   $905,484 
Convertible notes, net  $972,500   $905,484 

 

Accrued interest was approximately $198,000 and $131,000 as of September 30, 2024 and December 31, 2023. The May 2022 Mast Note was extended through May 27, 2025 at a cost of approximately $82,000, and which is included in the amount outstanding and payable to Mast as of September 30, 2024. Accrued interest was approximately $89,000 as of September 30, 2023.

 

The Company recognized approximately $0 of interest expense attributable to the amortization of the debt discount from the original debt discount, deferred financing costs, fair value allocated to the warrants during the three and nine months ended September 30, 2024 compared to $0 and approximately $146,000 during the three and nine months ended September 30, 2023, respectively.

 

Effective January 1, 2023, the Company adopted ASU 2020-06, which resulted in the reversal of the original BCF amount to additional paid in capital for approximately $0.2 million, a reversal of the unamortized debt discount related to the BCF for approximately $0.1 million, with the balance of approximately $0.1 million being recorded through retained earnings.

 

June 2022 Blue Lake Financing

 

In June 2022, the Company entered into a securities purchase agreement with one institutional investor, whereby the Company issued one convertible note in the aggregate principal amount of $335,000 convertible into shares of common stock of the Company (“June 2022 Blue Lake Note”). The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from issuance or upon event of default. Investor has the right at any time following issuance date to convert all or any part of the outstanding and unpaid amount of the note into the Company’s common stock at a conversion price established at a fixed rate of $0.10. The Company granted a total number of 837,500 warrants convertible into an equivalent number of the Company common shares at a strike price of $0.20 up to five years after issuance. The Placement agent was also granted a total amount of 83,750 warrants as part of a finder’s fee agreement. Portion of the proceeds will be used to retire some of the November/December 2021 notes.

 

In May 2024, Blue Lake converted the balance of their note of approximately $531,000 including principal, accrued interest and default penalty, into 7,605,760 common shares of the Company.

 

As of September 30, 2024, and December 31, 2023, convertible note under the June 2022 Blue Lake Financing, net of debt discount, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
Blue Lake Convertible note, 16% coupon June 2023, inclusive of accrued interest and penalty  $-   $495,800 
Convertible notes, net  $-   $495,800 

 

The Company recognized approximately $8,500 and $35,000 of interest expense attributable to the amortization of the debt discount from the original debt discount, deferred financing costs, fair value allocated to the warrants during the three and nine months ended September 30, 2024, respectively. The Company recognized approximately $0 and approximately $62,000 of interest expense attributable to the amortization of the debt discount from the original debt discount, deferred financing costs, fair value allocated to the warrants and BCF during the three and nine months ended September 30, 2023.

 

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The Company adopted ASU 2020-06 effective January 1, 2023, which resulted in the reversal of the original BCF amount to additional paid in capital of approximately $0.2 million, reversal of the unamortized debt discount of approximately $0.1 million related to the BCF and the balance of $0.1 million being recorded through retained earnings.

 

Other short-term advances

 

As of September 30, 2024 compared to December 31, 2023, other short-term advances consist of the following amounts obtained from various employees and related parties:

 

Other Advances 

September 30,

2024

  

December 31,

2023

 
Short term advance from CFO – Related Party  $50,050   $35,050 
Short term advance from CEO – Related Party   50,000    50,000 
Short term advances – bridge investors & others   210,000    210,000 
Short term advances – Autotelic Inc. – Related Party   2,070,000    1,470,000 
Short term advance  $2,380,050   $1,765,050 

 

During the year ended December 31, 2023, Autotelic provided $1.4 million in various short-term loans to the Company. During the nine months ended September 30, 2024 Autotelic Inc. provided additional short-term funding of $600,000 to the Company. As such, approximately $2.01 million was outstanding and payable to Autotelic at September 30, 2024.

 

The Company’s CFO was owed approximately $25 thousand at December 31, 2022. During the year ended December 31, 2023, the company’s CFO provided additional short-term advance of $10 thousand. During the nine months ended September 30, 2024, the CFO provided additional short-term funding of $15 thousand. As such, approximately $50 thousand was outstanding from the Company’s CFO at September 30, 2024.

 

In December 2023, the Company received $50 thousand from the company’s CEO. As such, $50 thousand was outstanding to the Company’s CEO at September 30, 2024.

 

As of September 30, 2024 and December 31, 2023, respectively, approximately $210,000 was outstanding as short-term advances from certain bridge investors.

 

NOTE 6 - JOINT VENTURE WITH GMP BIO AND AFFILIATES, EQUITY METHOD INVESTMENT

 

On March 31, 2022, the Company entered into (i) a joint venture (the “JV”) agreement with Dragon and GMP Bio, both affiliates of GMP, (and the Company, Dragon and GMP Bio are collectively called the “Parties”) (the “JVA”), (ii) a license agreement for rights to OT-101 (the “US License Agreement”) for the territory within the United States of America (the “US”) with Sapu Holdings, LLC, a subsidiary of GMP Bio and (iii) a license agreement for rights to OT-101 for the rest of the world with GMP Bio (the “Ex-US Rights Agreement”, and the US License Agreement and the Ex-US License Agreement are collectively called the “Agreements”). Further, GMP Bio has been developing a new nanomedicine portfolio. The development of this platform is expected to move through filings with the US FDA, and other regulatory bodies outside of the United States, moving into clinical programs with the ultimate goal of commercializing the products, assuming a successful outcome for the products. For more information on the JV, JVA, and Agreements, refer to our 2022 Annual Report on Form 10-K/A filed with the SEC on April 19, 2023.

 

As of the effective date of the formation of the JV, the combined enterprise value of GMP Bio was approximately $50.4 million, comprising of the fair value of the Company’s investment in GMP Bio of approximately $22.7 million and the total original capital contributions by Dragon Overseas of approximately $27.7 million. As of September 30, 2024, the JV had approximately $32.8 million in assets, not including GMP Bio’s capital subscriptions of approximately $8.8 million; recorded approximately $1.0 million in liabilities and incurred approximately $4.8 million and approximately $4.5 million in operational expenses for the nine months ended September 30, 2024 and 2023, respectively. While GMP’s fiscal year commences on April 1 and ends on March 31, the Company has reported the operational expenses for the same fiscal period as the Company. The Company elected the fair value option under subsection of Section 825-10-15 to account for its equity-method investment as the Company believes that it the most appropriate method to properly value the Company and record a change in value when and upon conducting a fair value assessment. GMP Bio conducted a fair value valuation study of the entity. Based on the results of the valuation study and the 45% ownership of the Company in GMP Bio, the Company reported a change in fair value of the Company. As such, the Company reported a change in fair value of the investment in GMP Bio of approximately $13 thousand at December 31, 2023. No change has been assessed to the fair value of the company during the nine months ended September 30, 2024.

 

28

 

 

A summary of the change in fair value of our investment in GMP Bio, as of September 30, 2024 and December 31, 2023 is shown below:

 

  

September 30,

2024

  

December 31,

2023

 
Balance at January 1, 2024 and 2023  $22,653,225   $22,640,521 
Add: change in fair value of investment in GMP Bio   -    12,704 
           
Balance at December 31, 2024 and 2023  $22,653,225   $22,653,225 

 

For information on the various notes from GMP, refer to Note 5 – GMP Notes of the Notes to the Consolidated Financial Statements above.

 

NOTE 7 - PRIVATE PLACEMENT AND JH DARBIE FINANCING

 

During the period from July 2020 to March 31, 2021, the Company entered into various subscription agreements with certain accredited investors, including the CEO, pursuant to the JH Darbie Financing, whereby the Company issued and sold a total of 100 Units, for total gross proceeds of approximately $5 million, pursuant to the JH Darbie Placement Agreement, with each Unit consisting of:

 

  25,000 shares of Edge Point Common stock for a price of $1.00 per share of Edge Point Common stock.
     
  One convertible promissory note, convertible up to 25,000 shares of Edge Point Common stock, at a conversion price of $1.00 per share or up to 138,889 shares of the Company’s common stock, at a conversion price of $0.18 per share.
     
  50,000 warrants to purchase an equivalent number of shares of Edge Point Common stock at $1.00 per share and an equivalent number of shares of the Company’s common stock at $0.20 per share with a three-year expiration date.

 

During the period between July 2023 and January 2024, the Company converted the debt of forty six accredited investors from the JH Darbie Financing (now referred to as “PPM-1”) into the new subscription agreements under the new financing (“PPM-2”- See Note 8 below), which resulted in conversion of $2.35 million of old debt into new debt to the Company.

 

As September 30, 2024 and December 31, 2023 funds received under the JH Darbie Financing, net of debt discount, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
Convertible promissory notes          
Subscription agreements - accredited investors  $-   $311,693 
Subscription agreements – related party   -    - 
Total convertible promissory notes  $-   $311,693 

 

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The Company incurred approximately $0.64 million of issuance costs, including legal costs of approximately $39,000, that are incremental costs directly related to the issuance of the various instruments bundled in the offering.

 

Concurrently with the sale of the Units, JH Darbie was granted a warrant, exercisable over a five-year period, to purchase 10% of the number of Units sold in the JH Darbie Financing. As such, the Company granted 10 Units to JH Darbie pursuant to the JH Darbie Placement Agreement.

 

The terms of convertible notes are summarized as follows:

 

  Term: Through March 31, 2022, extended further to March 31, 2023
  Coupon: 16%.
  Convertible at the option of the holder at any time in the Company’s Common Stock or Edgepoint Common Stock.
  The conversion price is initially set at $0.18 per share for the Company’s Common Stock or $1.00 for Edgepoint Common Stock, subject to adjustment.

 

In February 2022, the Company and all except one of the Investors agreed to extend the maturity date of the Notes from March 31, 2022, to March 31, 2023. In consideration for the extension of the Notes, the Company issued to the Investors an aggregate of 33,000,066 Oncotelic Warrants at a price of $0.15 per share of Company’s Common Stock. Each Investor were entitled to receive 333,334 Oncotelic Warrants for each Unit purchased. Upon the amendment of the terms of the convertible notes under the private placement memorandum. As incentive to extend the maturity date, approximately 33 million warrants were issued to the Unit Holders who participated in the amendment. The approximately 33 million warrants to purchase shares of our Common Stock expired on March 31, 2024. The Company repaid the 1-unit holder who did not participate in the amendment shortly after March 31, 2022. Further, during the year ended December 31, 2023, the Company repaid two of the unit holders, who held 5 units and opted not to participate in the new JH Darbie financing. While the Company had been in default under the PPM-1 since April 2023, as of the date of this Quarterly Report, with the conversion of the rest of the Note Holders under the PPM-1, the event of default has been addressed.

 

The Company recognized amortization expense related to the debt discount and debt issuance costs of approximately $0 and $8,400 for the nine months ended September 30, 2024 and, 2023 respectively, which is included in interest expense in the statements of operations.

 

NOTE 8 – PRIVATE PLACEMENT -2 (PPM-2) AND JH DARBIE FUNDING

 

During the period between July 2023 to January 2024, the Company entered into a series of subscription agreements with forty six accredited investors (the “Financing”) whereby the Company issued and converted a total of 94 Units from the previous PPM (“PPM -1”- See Note 7 above) into the current subscription agreements under the PPM-2, which resulted in conversion of $2.35 million of old debt into new debt to the Company; and the Company did not receive any cash proceeds through the July 2023 through January 2024 conversions., with each Unit consisting of:

 

  One 16% convertible unsecured promissory note (the “Note”) of $25,000, convertible into up to 250,000 shares of the Company’s common stock (par value of $0.01) based on a conversion price of $0.10 per share.
     
  250,000 warrants to purchase an equivalent number of shares of the Company’s common stock at a strike price of $0.12 per share (“Oncotelic warrant”).

 

JH Darbie and the Company are parties to a March 2023 placement agent agreement (“Agreement”) pursuant to which DH Darbie had the right to sell a minimum of 10 Units and a maximum of 200 Units on a best-efforts basis. For the 4 tranches of conversion related to PPM 2, placement agent fees of $377,500 were paid to JH Darbie. Based on the placement agent agreement, JH Darbie was entitled to a non-refundable $25,000 fee to start the due diligence process and 2% due diligence fees and 13% commissions on all subsequent conversions or new funding. In addition, the Company provided warrant coverage equal to 13 % of all of the units sold to JH Darbie. As the Company converted an aggregate of 94 units, JH Darbie was entitled to earn a total of 3,055,000 warrants. A total of 5 unit holders under the PPM-1 opted not to participate in the PPM-2.

 

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In connection with the consummation of Tranche 1, 2 and 3 and 4 of the July 2023 PPM, the Company entered into a Registration Rights Agreement granting certain registration rights with respect to the shares of the Company’s Common Stock issued in connection with the financing, as well as the shares of the Company’s Common Stock issuable upon exercise of the Warrants. The issuance of the Units is exempt from the registration requirements of the Securities Act of 1933, as amended (“Securities Act”), in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as provided in Rule 506 of Regulation D promulgated thereunder. The shares of common stock and warrants and any shares of common stock issuable upon exercise of the warrants, have not been registered under the Securities Act or any other applicable securities laws, and unless so registered, may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act.

 

As of September 30, 2024 and December 31, 2023, the PPM2 - JH Darbie Financing, net of debt discounts, consisted of the following amounts:

 

  

September 30,

2024

   December 31,
2023
 
Convertible promissory notes          
PPM-2 Darbie Financing, inclusive of accrued interest, including related parties  $2,267,849   $1,898,468 
Total PPM-2 Darbie Financing, net of discounts  $2,267,849   $1,898,468 

 

The Company incurred approximately $0.4 million of issuance costs under the PPM-2 and are incremental costs directly related to the issuance of the various instruments bundled in the offering. Concurrently with the sale of the Units, JH Darbie was granted a total of 3,055,000 stock warrants, exercisable over a two-year period.

 

The terms of convertible notes are summarized as follows:

 

  Term: through January 31, 2026
  Coupon: 16%
  Convertible at the option of the holder at any time into the Company’s common stock
  Conversion price is set at $0.10 per share subject to standard anti-dilution provision.

 

Management reviewed the guidance per ASC 470-60 Troubled debt restructurings and ASC 470-50 Debt-Modifications and Extinguishments and concluded that the terms of the agreements were substantially different and, accounted for the transaction as a debt extinguishment. The transaction related to T4 resulted in a loss from debt extinguishment of approximately $88,000, which is presented in other expense in the consolidated statements of operations for the year ended March 31, 2024. The estimated volume weighted grant date fair value of approximately $0.026 per share associated with the warrants to purchase up to 3,390,000 shares of common stock issued in this offering, or a total of approximately $88,000 was recorded to additional paid-in capital. All warrants sold in this offering have an exercise price of $0.12 per share of the Company stock, subject to adjustment, are exercisable immediately and expire two years from the date of issuance. The fair value of the warrants was estimated using a Black Scholes valuation models using the following input values:

  

Expected Term   2 years 
Expected volatility   173%
Risk-free interest rate   4.29%
Dividend   0.00%

 

The Company recorded approximately $318,000 as an initial debt discount related to the four tranches of PPM 2. The Company recognized amortization expense related to the debt discount and debt issuance costs of approximately $39,800 and $117,000 for the three and nine months ended September 30, 2024. Similarly, The Company recognized amortization expense related to the debt discount and debt issuance costs of approximately $18,600 for the three and nine months ended September 30, 2023.

 

During the nine months ended September 30, 2024, and 2023, the Company incurred approximately $270,000 and $37,000 of interest expense related to the convertible notes, respectively.

 

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NOTE 9 - RELATED PARTY TRANSACTIONS

 

Master Service Agreement with Autotelic Inc.

 

In October 2015, Oncotelic entered into a Master Service Agreement (the “MSA”) with Autotelic Inc., a related party that is partly-owned by the Company’s CEO Vuong Trieu, Ph.D. Dr. Trieu, a related party, is a control person in Autotelic Inc. Autotelic Inc. currently owns less than 10% of the Company. The MSA stated that Autotelic Inc. would provide business functions and services to the Company and allowed Autotelic Inc. to charge the Company for these expenses paid on its behalf. The MSA includes personnel costs allocated based on amount of time incurred and other services such as consultant fees, clinical studies, conferences and other operating expenses incurred on behalf of the Company. The Company had minimally used the services under the MSA since the formation of the JV with Dragon. The MSA requires a 90-day written termination notice in the event either party requires to terminate such services.

 

Expenses related to the MSA were approximately $500 and $1,500 and for the three and nine months ended September 30, 2024 as compared to approximately $500 and $11,000 for the same period of 2023.

 

License Agreement with Autotelic Inc.

 

In September 2021, the Company entered into an exclusive License Agreement with Autotelic. For more information on the exclusive license Agreement with Autotelic, refer to our 2023 Annual Report on Form 10-K filed with SEC on April 15, 2024.

 

Note Payable and Short-Term Loan – Related Parties

 

In April 2019, the Company issued a convertible note to Dr. Trieu totaling $164,444, including OID of $16,444, receiving net proceeds of $148,000, which was used by the Company for working capital and general corporate purposes. The Company issued a Fall 2019 Note to Dr. Trieu in the principal amount of $250,000. Dr. Trieu also offset certain amounts due to him in the amount of $35,000 and was converted into the Fall 2019 debt. During the year ended December 31, 2020, Dr. Trieu purchased a total of 5 Units under the private placement for a gross total of $250,000. During the year ended December 31, 2023, Dr Trieu provided short term loan of $50 thousand to the Company.

 

In May 2021, Autotelic provided an additional short-term funding of $250,000 to the Company, which was converted into the August 2021 Notes. Autotelic provided an additional $120,000 short-term loan to the Company during the year ended December 31, 2022. During the year ended December 31, 2023, Autotelic provided $1.4 million in short term advances to the Company. In addition, Autotelic provided a short term advance of $600,000 during the nine months ended September 30, 2024 and as such, approximately $2.01 million was outstanding and payable to Autotelic at September 30, 2024.

 

Artius Consulting Agreement

 

On March 9, 2020, the Company and Artius Bioconsulting, LLC (“Artius”), for which Mr. King is the Managing Member, entered into an amendment to the Consulting Agreement dated December 1, 2018, under which Artius agreed to serve as a consultant to the Company for services related to the Company’s business from time to time, effective December 1, 2019 (the “Effective Date”) (the “Artius Agreement”). For more information on this Agreement, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

No expense was recorded during the nine months ended September 30, 2024 and 2023, respectively, related to this Agreement.

 

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Maida Consulting Agreement

 

Effective May 5, 2020, the Company and Dr. Maida entered into an independent consulting agreement, commencing April 1, 2020 (the “Maida Agreement”), under which Dr. Maida will assist the Company in providing medical expertise and advice from time to time in the design, conduct and oversight of the Company’s existing and future clinical trials. For more information on this Agreement, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 15, 2024.

 

The Company recorded an expense of $0 during the nine months ended September 30, 2024 and 2023 related to this Agreement. Effective April 1, 2022, Dr Maida’s compensation shall be borne by the JVA with GMP Bio.

 

NOTE 10 - EQUITY PURCHASE AGREEMENT AND REGISTRATION RIGHTS AGREEMENT

 

On May 3, 2021, the Company entered into an Equity Purchase Agreement (“EPL”) and Registration Rights Agreement with Peak One Opportunity Fund LP (“Peak One” or the “Investor”). For further information on EPL, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024. The Company also filed a post-effective amendment Registration Statement on Form S-1 with the Commission on April 12, 2024, and the Form S-1 was declared effective on April 22, 2024. The Company filed the prospectus under rule 424b3 with the SEC on April 26, 2024.

 

During the nine months ended September 30, 2024 and 2023, the Company did not sell any shares of Common Stock under the EPL.

 

NOTE 11 - STOCKHOLDERS’ EQUITY

 

The following transactions affected the Company’s Stockholders’ Equity:

 

Issuance of Common Stock during the nine months ended September 30, 2024

 

In February 2024, Fourth Man partially converted $35,000 of their debt. In connection with the partial Note conversion, the Company issued 500,000 shares of Common Stock to Fourth Man.

 

In May 2024, Blue Lake converted the balance of their $531,000 debt, inclusive of accrued interest and penalty, into 7,605,760 shares of Common Stock of the Company.

 

Issuance of Common Stock during the nine months ended September 30, 2023

 

In February 2023, Blue Lake partially converted $71,750 of their debt. In connection with the partial Note conversion, the Company issued 1,025,000 shares of Common Stock to Blue Lake.

 

In June 2023, Blue Lake converted the full remainder of their $181,750 debt, accrued interest and penalty. In connection with this Note conversion, the Company issued 3,466,853 shares of Common Stock to Blue Lake.

 

In May and June 2023, Fourth Man converted $50,000 in principal and $30,000 in accrued interest into 1,192,857 shares of common stock.

 

In July 2023, Fourth Man converted approximately $43,000 balance in principal and accrued interest into 627,538 shares of Common Stock.

 

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NOTE 12– STOCK-BASED COMPENSATION

 

Options

 

Pursuant to the Merger, the Company’s Common Stock and corresponding outstanding options survived. The below information details the Company’s associated option activity.

 

As of September 30, 2024, the Company had options to purchase Common Stock that were outstanding under three stock option plans – the 2017 Equity Incentive Plan (the “2017 Plan”), the 2015 Equity Incentive Plan (the “2015 Plan”) and the 2005 Stock Plan (the “2005 Plan”). Under the 2017 Plan, up to 2,000,000 shares of the Company’s Common Stock may be issued pursuant to awards granted in the form of nonqualified stock options, restricted and unrestricted stock awards, and other stock-based awards. Under the 2015 and 2005 Plans, taken together, up to 27,250,000 shares of the Company’s Common Stock may be issued pursuant to awards granted in the form of incentive stock options, nonqualified stock options, restricted and unrestricted stock awards, and other stock-based awards

 

Employees, consultants, and directors are eligible for awards granted under the 2017 and 2015 Plans. Since the adoption of the 2015 Plan, no further awards may be granted under the 2005 Plan, although options previously granted remain outstanding in accordance with their terms.

 

Compensation based stock option activity for qualified and unqualified stock options are summarized as follows:

 

       Weighted 
       Average 
For the nine months ended September 30, 2024  Shares   Exercise Price 
Outstanding at January 1, 2024   24,177,761   $0.21 
Expired or cancelled   -    - 
Outstanding at September 30, 2024   24,177,761    0.21 
Options exercisable at September 30, 2024   13,985,261    0.10 

 

       Weighted 
       Average 
For the nine months ended September 30, 2023  Shares   Exercise Price 
Outstanding at January 1, 2023   25,690,261   $0.23 
Expired or cancelled   (1,512,500)   0.46 
           
Outstanding at September 30, 2023   24,177,761    0.21 

 

Information on compensation-based stock option activity for qualified and unqualified stock options for the year ended December 31, 2023 can be found in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on April 12, 2024.

 

The following table summarizes information about options to purchase shares of the Company’s Common Stock outstanding and exercisable at September 30, 2024:

  

Exercise prices  

Outstanding

Options

  

Weighted-

Average

Remaining Life

In Years

  

Weighted-

Average

Exercise

Price

  

Number

Exercisable

 
                  
$0.1 to $0.15     16,250,000    7.5   $0.12    6,057,500 
 0.16 to $0.21     5,502,761    6.8    0.16    5,502,761 
 0.22 to $0.37     1,550,000    3.3    0.28    1,550,000 
 0.38 to $0.72     500,000    1.5    0.72    500,000 
 0.73 to $15.0     375,000    0.7    4.14    375,000 
      24,177,761    6.8   $0.21    13,985,261 

 

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The compensation expense attributed to the issuance of the options is recognized as they are vested. The employee stock option plan stock options are generally exercisable for ten years from the grant date and vest over various terms from the grant date to three years.

 

As of September 30, 2024, there was no unamortized stock compensation cost related to the stock options granted during the year as the stock options granted during the year ended December 31, 2023 are considered vested. Of the approximately 14 million unvested stock options, the vesting criteria for 7.3 million options is still being evaluated as on the date of this Report, as those options are subject to individual milestone achievements. For more information on the stock options, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

The Company amortized $0 stock compensation expense during the nine months ended September 30, 2024 and 2023 on the 2021 and 2022 grants.

 

Warrants

 

The Company has issued warrants in connection with the various financings conducted by the Company. For more information on the warrant issuances, refer to our 2022 Annual Report on Form 10-K/A filed with the SEC on April 17, 2023. The Company issued 10,576,924 warrants related to the November/December 2021 Notes (See Note 6). The fair value of these warrants on issue date amounted to $1,172,753 as calculated using a Black Scholes valuation model.

 

The issuance of warrants to purchase shares of the Company’s Common Stock, including those attributed to debt issuances, as of September 30, 2024 and 2023 are summarized as follows:

 

       Average 
For the nine months ended September 30, 2024  Shares   Exercise Price 
Outstanding at January 1, 2024   61,500,355   $0.15 
Issued during the nine months ended September 30, 2024   3,390,000    0.12 
Exercised / cancelled during the nine months ended September 30, 2024   (33,000,066)   0.15 
Outstanding at September 30, 2024   31,890,289   $0.13 

 

       Average 
For the nine months ended September 30, 2023  Shares   Exercise Price 
Outstanding at January 1, 2023   81,072,855   $0.18 
Issued during the nine months ended September 30, 2023   11,300,000    0.12 
Exercised / cancelled during the nine months ended September 30, 2023   (42,737,500)   0.20 
Outstanding at September 30, 2023   49,635,355   $0.15 

 

The following table summarizes information about warrants outstanding and exercisable at September 30, 2024:

  

    Outstanding and exercisable 
        Weighted-   Weighted-     
        Average   Average     
    Number   Remaining Life   Exercise   Number 
Exercise Price   Outstanding   in Years   Price   Exercisable 
$0.13    961,539    2.15    0.13    961,539 
 0.20    4,373,750    2.49-2.73    0.20    4,373,750 
 0.12    26,555,000    0.77-1.33    0.12    26,555,000 
                       
      31,890,289    1.24   $0.13    31,890,289 

 

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NOTE 13 – INCOME TAXES

 

The Company had gross deferred tax assets, which primarily relate to net operating loss carryforwards. As of December 31, 2023, the Company had gross federal and state net operating loss carryforwards, which are available to offset future taxable income, if any. The Company recorded a valuation allowance in the full amount of its net deferred tax assets since realization of such tax benefits has been determined by our management to be less likely than not. Information on our deferred tax assets and liabilities can be found in our 2023 Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on April 12, 2024.

 

Portions of these carryforwards will expire through 2038, if not otherwise utilized. The Company’s utilization of net operating loss carryforwards could be subject to an annual limitation. as a result of certain past or future events, such as stock sales or other equity events constituting a “change in ownership” under the provisions of Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, and similar state provisions. The annual limitations could result in the expiration of net operating loss carryforwards and tax credits before they can be utilized. We have not performed a formal analysis, but we believe our ability to use such net operating losses and tax credit carryforwards will be subject to annual limitations, due to change of ownership control provisions under Section 382 and 383 of the Internal Revenue Code, which would significantly impact our ability to realize these deferred tax assets.

 

NOTE 14 – COMMITMENTS AND CONTINGENCIES

 

Leases

 

Currently, the Company is leasing the office located at 29397 Agoura Road, Suite 107, Agoura Hills, CA 91301 on a month-to-month basis until such time a new office is identified. The Company believes the office is sufficient for its current operations.

 

PointR Merger Contingent Consideration

 

The total purchase price in the PointR Merger of $17,831,427 represented the consideration transferred from the Company and was calculated based on the number of shares of Common Stock plus the preferred shares outstanding but convertible into Common Stock outstanding at the date of the PointR Merger and included $2,625,000 of contingent consideration of shares issuable to PointR shareholders, which could increase to $15 million of contingent consideration, upon achievement of certain milestones. For more information on the PointR Merger Contingent Consideration, 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

Third Party Service Provider Claim

 

The Company had disputed a judgement of $20,000 for a non-payment to a third service provider. The Company considered the claim to be immaterial to the financial position of the Company. The Company had filed a counter claim on the third-party service provider as the Company believed the claim to be false and malicious to the interests of the Company. The Honorable Court overruled the previous judgement and the Company had sued the third-party service provider. In March 2024, the Honorable Court’s decision was in favor of the Company due to the reasons described above and the matter has been dismissed. The third party service provider had filed an appeal with the Honorable Court, and the Honorable Court dismissed their appeal.

 

Other claims

 

From time to time, the Company may become involved in certain claims arising in the ordinary course of business. One of the Company’s ex-employees has made a claim against the Company. The Company is evaluating the validity of the claim, as the Company believes that such claim has limited merits and is hopeful to attain a positive outcome for such claim. Since the Company is still evaluating the claim, we are unable to quantify the amount such claim would be settled at, if at all settled.

 

NOTE 15 – SUBSEQUENT EVENTS

 

The Company performed an evaluation of subsequent events through November 19, 2024, the date on which the consolidated financial statements were available to be issued. The Company did not identify any material events requiring adjustment to or disclosure in the accompanying consolidated financial statements.

 

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ITEM 2: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Note Regarding Forward-Looking Statements

 

This Quarterly Report on Form 10-Q (the “Quarterly Report” or “Report”) includes a number of forward-looking statements that reflect management’s current views with respect to future events and financial performance. Forward-looking statements are projections in respect of future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Those statements include statements regarding the intent, belief or current expectations of us and members of our management team, as well as the assumptions on which such statements are based.

 

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, or performance, especially the forward-looking statements enumerated below. These statements are only predictions and involve known and unknown risks, uncertainties and other factors. Some of these risks are included in the section entitled “Risk Factors” set forth in this Quarterly Report and in other reports that we file with the SEC. The occurrence of any of these risks, or others of which we are currently unaware, may cause our company’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. These risks include, by way of example and without limitation:

 

  our ability to successfully commercialize our products and services on a large enough scale to generate profitable operations;
     
  our ability to maintain and develop relationships with customers and suppliers;
     
  our ability to successfully integrate acquired businesses or new products, or to realize anticipated synergies in connection with acquisitions of businesses or products;
     
  expectations concerning our ability to raise additional funding and to continue as a going concern;
     
  our ability to successfully implement our business plan;
     
  our ability to successfully operate GMP Biotechnology Limited (“GMP Bio”), our joint venture with Dragon Overseas Limited (“Dragon”), to develop the existing product portfolio, or to have a successful IPO for GMP Bio as planned, or GMP Bio’s success with the development of its new product portfolio being developed within GMP Bio, including the success of that in conjunction with the ultimate commercialization of the new product portfolio;
     
  our ability to avoid, or to adequately address any intellectual property claims brought by third parties; and
     
  the anticipated impact of any changes in industry regulation.
     
  building and the success of our nanoparticle platform and the related success of launching the platform
     
  the success of the launch of a company with a DAO infrastructure, the success of the entity and the plans surrounding the pet and animal health, the ability for the Company to register the tokens of Pet2Dao, the actual filing of a registration statement and approval of the tokens as registrable securities with the SEC through a registration statement, the ability of the tokens to be tradable or any value such tokens may have if they become tradable.

 

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Readers are urged to carefully review and consider the various disclosures made by us in this report and in our other reports filed with the SEC. We undertake no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes in the future operating results over time except as required by law. We believe that our assumptions are based upon reasonable data derived from and known about our business and operations. No assurances are made that actual results of operations or the results of our future activities will not differ materially from our assumptions.

 

Corporate History

 

Oncotelic Therapeutics, Inc. (“Oncotelic”), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic conducts business activities through Oncotelic and its wholly-owned subsidiaries, Oncotelic, Inc., a Delaware corporation, PointR Data, Inc. (“PointR”), a Delaware corporation, Pet2DAO Inc., a Delaware corporation and EdgePoint AI, Inc. (“Edgepoint”), a Delaware Corporation for which there are non-controlling interests, (Oncotelic, Oncotelic Inc., PointR, Pet2DAO and Edgepoint are collectively called the “Company” or “We”). The Company completed a reverse merger with Oncotelic Inc in April 2019, a merger with PointR in November 2019 and formed a subsidiary Edgepoint in February 2020. For more information on these mergers, 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

Company Overview

 

We are a clinical stage biopharmaceutical company developing drugs for the treatment of cancer. Our goal is to advance our drug candidates into late-stage pivotal clinical trials and either sell marketing rights to a larger pharmaceutical company or seek FDA approval ourselves.

 

The Company is currently developing OT-101, through its joint venture (“JV”) with Dragon Overseas Capital Limited (“Dragon”) and GMP Biotechnology Limited (“GMP Bio”), both affiliates of Golden Mountain Partners (“GMP”), for various cancers and COVID-19, Artemisinin for COVID-19 and AI technologies for manufacturing, COVID-19 and other AI technologies. The Company is also independently planning to develop OT-101 for certain animal health indications and contemplating using crypto currencies for that platform. The Company has acquired apomorphine for Parkinson’s Disease, erectile dysfunction and female sexual dysfunction. In addition, the Company is evaluating the further development of its product candidates OXi4503 as a treatment for acute myeloid leukemia and myelodysplastic syndromes and CA4P in combination with a checkpoint inhibitor for the treatment of advanced metastatic melanoma.

 

In 2020, the Company had entered into an agreement and supplemental agreement with GMP for a total of $1.2 million to render services for the development of OT-101 for COVID-19 and such amount was recorded as revenue upon completion of all performance obligations under the agreement. The Company secured various financings from GMP between 2020 and early 2022. For information on the GMP financings, please refer to GMP Note purchase agreements and unsecured notes below.

 

For more information on the GMP debt financing and the JV, refer to Notes 5 and 6 of the unaudited Notes to the Consolidated Financial Statements.

 

In November 2022, the Company formed a Decentralized autonomous organization (“DAO”) entity, Pet2DAO, Inc. (“Pet2DAO”), as a wholly owned subsidiary. For more information on Pet2DAO, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

Since April 2019, we have been operating under significant capital constraints, which has curtailed our ability to achieve meaningful progress in either of the Company’s two clinical programs – one of which is developing OXi4503 as a treatment for acute myeloid leukemia and myelodysplastic syndromes and the other of which is developing CA4P in combination with a checkpoint inhibitor for the treatment of advanced metastatic melanoma. We believe that the merger of Oncotelic and Oncotelic Inc. creates a combined company that has potential to generate shareholder value through a promising pipeline of next generation immunotherapies targeting several significant cancer markets where there is a lack of therapeutic options and lack of an effective immunotherapy protocol.

 

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Forever Prosperity (previously GMP) Note purchase agreements and unsecured notes

 

Between June 2020 and January 2022, the Company entered into various purchase agreements and promissory notes with GMP, cumulatively totaling $4.5 million. Such notes were assigned to Forever Prosperity, LLC, an affiliated entity of GMP.

 

For more information on the GMP debt financing, refer to Note 5 of the Notes to the Consolidated Financial Statements.

 

Joint Venture

 

In March 2022, the Company entered into (i) a joint venture (the “JV”) agreement with Dragon and GMP Bio, both affiliates of GMP, (and the Company, Dragon and GMP Bio are collectively called the “Parties”) (the “JVA”), (ii) a license agreement for rights to OT-101 (the “US License Agreement”) for the territory within the United States of America (the “US”) with Sapu Holdings, LLC, a subsidiary of GMP Bio and (iii) a license agreement for rights to OT-101 for the rest of the world with GMP Bio (the “Ex-US Rights Agreement”, and the US License Agreement and the Ex-US License Agreement are collectively called the “Agreements”). For more information on the JV, JVA, and Agreements, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

In addition to the development of OT-101, GMP Bio has been developing a new nanomedicine portfolio. The development of this platform is expected to move through filings with the US FDA, and other regulatory bodies outside of the United States, moving into clinical programs with the ultimate goal of commercializing the products, assuming a successful outcome for the products. While the Company believes that its expectations are reasonable and that the product development for the nanomedicine platform by GMP Bio will be successful, the Company cannot guarantee future results, levels of activity, success of the development or clinical trials, future performance or the ultimate success of GMP Bio’ endeavors related to the success of its efforts ultimately, resulting in any change in valuation for the Company on account of its ownership in GMP Bio.

 

New Private Placement with JH Darbie

 

In July 2023, the Company entered into a series of subscription agreements with 15 accredited investors which resulted in a conversion of a gross amount of $1.0 million, consisting of 40 notes, under the prior JH Darbie Financing into new debt to the Company. JH Darbie and the Company are parties to a March 2023 placement agent agreement (“Agreement”) pursuant to which JH Darbie has the right to sell/convert a minimum of 10 Units and a maximum of 200 Units on a best-efforts basis. Further, in October 2023, the Company entered into a series of subscription agreements with 27 accredited investors which resulted in a conversion of a gross amount of $1.05 million, consisting of 42 notes, under the prior JH Darbie Financing into new debt to the Company. Additionally, in January 2024, Company entered into a series of subscription agreements with 4 accredited investors which resulted in a conversion of a gross amount of $0.3 million, consisting of 12 notes. The July 2023, October 2023 and January 2024 conversions fully converted JH Darbie PPM-1 notes into PPM-2 notes. For more information on the new JH Darbie Financing, refer to Note 8 of these Notes to the Consolidated Financial Statements.

 

In January 2024, Company entered into a series of subscription agreements with 4 accredited investors which resulted in a conversion of a gross amount of $0.3 million, consisting of 12 notes. The July 2023, October 2023 and January 2024 conversions fully converted JH Darbie PPM-1 notes into PPM-2 notes. For more information on the new JH Darbie Financing, refer to Note 8 of these Notes to the Consolidated Financial Statements.

 

March 2022 Financing

 

In March 2022, the Company entered into a Securities Purchase Agreement with Fourth Man, pursuant to which the Company issued convertible promissory note in the aggregate principal amount of $0.25 million, convertible into shares of common stock of the Company. The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from issuance or upon event of default. As of December 31, 2022, this note is in Investors have the right at any time following issuance date to convert all or any part of the outstanding and unpaid amount of the note into the Company’s Common Stock at a conversion price established at a fixed rate of $0.10. The Company granted a total number of 1,250,000 warrants convertible into an equivalent number of the Company common shares at a strike price of $0.20 up to five years after issuance. The Placement agent was also granted a total of 125,000 warrants convertible into an equivalent number of the Company Common Stock at a strike price of $0.20 up to five years after issuance, as part of a finder’s fee agreement. In February 2024, the Company converted $35,000 in principal, legal fees and accrued interest of the Fourth Man March 2022 note, into 500,000 shares of common stock.

 

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May 2022 Note

 

In May 2022, the Company entered into a securities purchase agreement with one institutional investor, whereby the Company issued one convertible note in the aggregate principal amount of $605,000 convertible into shares of common stock of the Company (“May 2022 Mast Note”). The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from issuance or upon event of default. Investor has the right at any time following issuance date to convert all or any part of the outstanding and unpaid amount of the note into the Company’s common stock at a conversion price established at a fixed rate of $0.10. The Company granted a total number of 3,025,000 warrants convertible into an equivalent number of the Company common shares at a strike price of $0.20 up to five years after issuance. The Placement agent was also granted a total amount of 302,500 as part of a finder’s fee agreement. Portion of the proceeds were be used to retire some of the November/December 2021 notes. In May 2024, the May 2022 Note was extended till May 27, 2025, at a cost of 10% of the outstanding Note amount, including interest and penalty.

 

For more information on the May 2022 Financing, refer to Note 5 of current Notes to the Consolidated Financial Statements.

 

June 2022 Financing

 

In June 2022, the Company entered into a securities purchase agreement with one institutional investor, whereby the Company issued one convertible note in the aggregate principal amount of $335,000 convertible into shares of common stock of the Company (“June 2022 Blue Lake Note”). The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from issuance or upon event of default. The investor has the right at any time following issuance date to convert all or any part of the outstanding and unpaid amount of the note into the Company’s common stock at a conversion price established at a fixed rate of $0.10. The Company granted a total number of 837,500 warrants convertible into an equivalent number of the Company common shares at a strike price of $0.20 up to five years after issuance. The Placement agent was also granted a total of 83,750 warrants convertible into an equivalent number of the Company Common Stock at a strike price of $0.20 up to five years after issuance, as part of a finder’s fee agreement. A portion of the proceeds were used to retire some of the November/December 2021 notes. In May 2024, Blue Lake converted remainder of their debt balance, including accrued interest and penalty, of approximately $531,000 into 7,605,760 shares of the Company’s Common Stock.

 

For more information on the June 2022 Financing, refer to Note 5 of current Notes to the Consolidated Financial Statements.

 

Short-term loans

 

In May 2021, Autotelic provided an additional short-term funding of approximately $0.3 million to the Company, which was converted into the August 2021 Notes. Autotelic provided an additional $0.1 million short term loan to the Company during the year ended December 31, 2022. During the year ended December 31, 2023, Autotelic provided $1.4 million in various short-term loans to the Company. In the nine months ended September 30, 2024 Autotelic Inc. provided additional short-term funding of $600,000 to the Company. As such, approximately $2.01 million was outstanding and payable to Autotelic at September 30, 2024.

 

The Company’s CFO was owed approximately $25,000 at December 31, 2022. During the year ended December 31, 2023, the company’s CFO provided an additional short-term advance of $10,000. During the nine months ended September 30, 2024, the CFO provided additional short-term funding of $15,000. As such, approximately $50,000 was outstanding from the Company’s CFO at September 30, 2024.

 

In December 2023, the Company received $50,000 from the company’s CEO. As such, $50,000 was outstanding to the Company’s CEO at September 30, 2024.

 

Equity Purchase Agreement

 

In May 2021, the Company entered into an Equity Purchase Agreement (the “EPL”) and Registration Rights Agreement (the “Registration Rights Agreement”) with Peak One Opportunity Fund, L.P. (“Peak One”), pursuant to which the Company shall have the right, but not the obligation, to direct Peak One to purchase up to $10.0 million (the “Maximum Commitment Amount”) in shares of the common stock, par value $0.01 per share (“Common Stock”) in multiple tranches. The Company filed a post-effective amendment for the EPL on April 12, 2024 with the SEC and the SEC has made the post-effective amendment effective on April 22, 2024. The Company filed a prospectus under rule 424b3 with the SEC on April 26, 2024. For more information on the EPL, refer to Note 10 of the Notes to the Unaudited Consolidated Financial Statements.

 

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Mosaic ImmunoEngineering, Inc. Term Sheet

 

In April 2024, the Company entered into a binding term sheet (the “Term Sheet”) with Mosaic ImmunoEngineering, Inc. (“Mosaic”). For more information on the Term Sheet, refer to the Current Report on Form 8-K filed with the SEC on April 29, 2024. In August 2024, Mosaic and the Company mutually agreed to extend the date of the Term Sheet to expire at the earlier of (1) the signing of definitive agreements or (2) December 31, 2024. This was to allow for both Companies to complete due diligence as well as agree and finalize the definitive agreements.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

The preparation of financial statements in accordance with U.S. generally accepted accounting principles requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expense during the reporting periods. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances at the time we make such estimates. Actual results and outcomes may differ materially from our estimates, judgments and assumptions. We periodically review our estimates in light of changes in circumstances, facts and experience. The effects of material revisions in estimates are reflected in the financial statements prospectively from the date of the change in estimate. Our significant accounting policies are more fully described in Note 2 to our Unaudited Consolidated Financial Statements included elsewhere in this Quarterly Report.

 

We define our critical accounting policies as those accounting principles that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. We believe the critical accounting policies used in the preparation of our financial statements that require significant estimates and judgments are the following:

 

Impairment of Long-Lived Assets

 

The Company reviews long-lived assets, including definite-lived intangible assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. The recoverability of these assets is determined by comparing the forecasted undiscounted net cash flows of the operation to which the assets relate to the carrying amount. If the operation is determined to be unable to recover the carrying amount of its assets, then these assets are written down first, followed by other long-lived assets of the operation to fair value. Fair value is determined based on discounted cash flows or appraised values, depending on the nature of the assets.

 

Intangible Assets

 

The Company records its intangible assets at cost in accordance with ASC 350, Intangibles – Goodwill and Other. The Company reviews the intangible assets for impairment on an annual basis or if events or changes in circumstances indicate it is more likely than not that they are impaired. These events could include a significant change in the business climate, legal factors, a decline in operating performance, competition, sale or disposition of a significant portion of the business, or other factors.

 

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Goodwill

 

Goodwill represents the excess of the purchase price of acquired business over the estimated fair value of the identifiable net assets acquired. Goodwill is not amortized but is tested for impairment at least once annually, at the reporting unit level or more frequently if events or changes in circumstances indicate that the asset might be impaired. The goodwill impairment test is applied by performing a qualitative assessment before calculating the fair value of the reporting unit. If, on the basis of qualitative factors, it is considered not more likely than not that the fair value of the reporting unit is less than the carrying amount, further testing of goodwill for impairment would not be required. Otherwise, goodwill impairment is tested using a two-step approach.

 

The first step involves comparing the fair value of the reporting unit to its carrying amount. If the fair value of the reporting unit is determined to be greater than its carrying amount, there is no impairment. If the reporting unit’s carrying amount is determined to be greater than the fair value, the second step must be completed to measure the amount of impairment, if any. The second step involves calculating the implied fair value of goodwill by deducting the fair value of all tangible and intangible assets, excluding goodwill, of the reporting unit from the fair value of the reporting unit as determined in step one. The implied fair value of the goodwill in this step is compared to the carrying value of goodwill. If the implied fair value of the goodwill is less than the carrying value of the goodwill, an impairment loss equivalent to the difference is recorded.

 

Convertible Instruments

 

The Company evaluates and accounts for conversion options embedded in its convertible instruments in accordance with ASC 815 “Derivatives and Hedging”.

 

ASC 815 generally provides three criteria that, if met, require companies to bifurcate conversion options from their host instruments and account for them as free-standing derivative financial instruments. These three criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur, and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. Professional standards also provide an exception to this rule when the host instrument is deemed to be conventional as defined under professional standards.

 

The Company accounts for convertible instruments (when it has determined that the embedded conversion options should not be bifurcated from their host instruments) in accordance with ASC 470-20 “Debt – Debt with Conversion and Other Options.” Accordingly, the Company records, when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments based upon the differences between the fair value of the underlying common stock at the commitment date of the note transaction and the effective conversion price embedded in the note. Original issue discounts under these arrangements are amortized over the term of the related debt to their earliest date of redemption. The Company also records when necessary deemed dividends for the intrinsic value of conversion options embedded in preferred shares based upon the differences between the fair value of the underlying common stock at the commitment date of the note transaction and the effective conversion price embedded in the note.

 

ASC 815-40 “Derivatives and Hedging – Contracts in Entity’s Own Equity” provides that, among other things, generally, if an event is not within the entity’s control could or require net cash settlement, then the contract shall be classified as an asset or a liability.

 

Derivative Financial Instruments Indexed to the Company’s Common Stock

 

We have generally issued derivative financial instruments, such as warrants, in connection with our equity offerings. We evaluate the terms of these derivative financial instruments in order to determine their accounting treatment in our financial statements. Key considerations include whether the financial instruments are freestanding and whether they contain conditional obligations. If the warrants are freestanding, do not contain conditional obligations and meet other classification criteria, we account for the warrants as an equity instrument. However, if the warrants contain conditional obligations, then we account for the warrants as a liability until the conditional obligations are met or are no longer relevant. Because no established market prices exist for the warrants that we issue in connection with our equity offerings, we must estimate the fair value of the warrants, which is as inherently subjective as it is for stock options, and for similar reasons as noted in the stock-based compensation section above. For financial instruments which are accounted for as a liability, we report any changes in their estimated fair values as gains or losses in our Consolidated Statement of Income.

 

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Variable Interest Entity (VIE) Accounting

 

We evaluate our ownership, contractual relationships and other interests in entities to determine the nature and extent of the interests, whether such interests are variable interests and whether the entities are VIEs in accordance with ASC 810, Consolidations. These evaluations can be complex and involve Management judgment as well as the use of estimates and assumptions based on available historical information, among other factors. Based on these evaluations, if the Company determines that it is the primary beneficiary of a VIE, the entity is consolidated into the financial statements.

 

Investments - Equity Method

 

The Company accounts for equity method investments at cost, adjusted for the Company’s share of the investee’s earnings or losses, which are reflected in the consolidated statements of operations. The Company periodically reviews the investments for other than temporary declines in fair value below cost and more frequently when events or changes in circumstances indicate that the carrying value of an asset may not be recoverable.

 

The Investment in GMP Bio represents the investment into equity securities for which the Company elected the fair value option pursuant to ASC 825-10-15 and subsequent fair value changes in the GMP Bio shares are included in the result from continuing operations. Refer to Note 6 to these Notes to the Consolidated Financial Statements.

 

Joint Venture agreement

 

We have equity interest in unconsolidated arrangement that is primarily engaged in the business of drug discovery, development, and commercialization, including but not limited to development and commercialization of TGF-beta therapeutics as well as establishing and operating contract development and manufacturing organization (CDMO) facilities and capabilities. The Company first review the arrangement to determine if it meets the definition of an accounting joint venture pursuant to ASC 323-10-20. In order to meet the definition of a joint venture, the arrangement must have all of the following characteristics, (i) the arrangement is organized within a separate legal entity, (ii) the entity is under the joint control of the venturers, (iii) the venturers must be able to exercise joint control through their equity investments, (iv) the qualitative characteristics of the entity, including its purpose and design must be consistent with the definition of a joint venture

 

We consolidate arrangements that are considered to be VIEs where we are the primary beneficiary. We analyze our investments in joint ventures to determine if the joint venture is considered a VIE and would require consolidation. We (i) evaluate the sufficiency of the total equity investment at risk, (ii) review the voting rights and decision-making authority of the equity investment holders as a group and whether there are limited partners (or similar owning entities) that lack substantive participating or kick out rights, guaranteed returns, protection against losses, or capping of residual returns within the group and (iii) establish whether activities within the venture are on behalf of an investor with disproportionately few voting rights in making this VIE determination.

 

To the extent that we own interests in a VIE and we (i) have the power to direct the activities that most significantly impact the economic performance of the VIE and (ii) have the obligation or rights to absorb losses or receive benefits that could potentially be significant to the VIE, then we would be determined to be the primary beneficiary and would consolidate the VIE. To the extent that we own interests in a VIE, then at each reporting period, we re-assess our conclusions as to which, if any, party within the VIE is considered the primary beneficiary.

 

To the extent that our arrangements do not qualify as VIEs, they are consolidated if we control them through majority ownership interests or if we are the managing entity (general partner or managing member) and our partner does not have substantive participating rights. Control is further demonstrated by our ability to unilaterally make significant operating decisions, refinance debt, and sell the assets of the joint venture without the consent of the non-managing entity and the inability of the non-managing entity to remove us from our role as the managing entity.

 

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We use the equity method of accounting for those arrangements where we exercise significant influence but do not have control. Under the equity method of accounting, our investment in each arrangement is included on our consolidated balance sheet; however, the assets and liabilities of the joint ventures for which we use the equity method are not included on our consolidated balance sheet.

 

When we sell or contribute properties to unconsolidated arrangements and retain a non-controlling ownership interest in such assets, we recognize the difference between the consideration received and the carrying amount of the asset sold or contributed when its derecognition criteria are met. The equity method investment we retain in such partial sale transactions is noncash consideration and is measured at fair value. As a result, the accounting for a partial sale will result in the recognition of a full gain or loss.

 

When circumstances indicate there may have been a reduction in the value of an equity investment, we evaluate whether the loss in value is other than temporary. If we conclude it is other than temporary, we recognize an impairment charge to reflect the equity investment at fair value.

 

The Company elected the fair value option under the fair value option Subsection of Section 825-10-15 to account for its equity-method investment.

 

Research and Development Expense

 

Research and development expense consist of costs we incur for the development of our investigational drugs and, to a lesser extent, for preclinical research activities. Research and development costs are expensed as incurred. Research and development expense include clinical trial costs, salaries and benefits of employees, including associated stock-based compensation, payments to clinical investigators, drug manufacturing costs, laboratory supplies and facility costs. Clinical trial costs are a significant component of our research and development expense, and these can be difficult to accurately estimate. Included in clinical trial costs are fees paid to other entities that conduct certain research and development activities on our behalf, such as clinical research organizations, or CROs. We estimate clinical trial expense based on the services performed pursuant to contracts with research institutions such as CROs and the actual clinical investigators. These estimates are based on actual time and expenses incurred by the CRO and the clinical investigators. Also included in clinical trial expense are costs based on the level of patient enrollment into the clinical trial and the actual services performed under the related clinical trial agreement. Changes in clinical trial assumptions, such as the length of time estimated to enroll all patients, rate of screening failures, patient drop-out rates, number and nature of adverse event reports and the total number of patients enrolled can impact the average and expected cost per patient and the overall cost of the clinical trial. Based on patient enrollment reports and services provided, we may periodically adjust estimates for the clinical trial costs. If we do not identify costs that we have begun to incur or if we underestimate or overestimate the level of services performed, the length of time for these services or the costs of these services, our actual expenses could differ from our estimates.

 

Share-Based Compensation

 

We record the estimated fair value of all share-based payments issued to employees and other service providers. Our share-based payments consist primarily of stock options. The valuation of stock options is an inherently subjective process, since market values are not available for any stock options in our equity securities. Market values are also not available on long-term, non-transferable stock options in other equity securities. With no market values on options to trade in our common stock and no comparable market values on any long-term non-transferable stock options, the process of valuing our stock options is even more uncertain and subjective. Accordingly, we use a Black-Scholes option pricing model to derive an estimated fair value of the stock options which we issue. The Black-Scholes option pricing model requires certain input assumptions, including the expected term of the options and the expected volatility of our common stock. Changes in these assumptions could have a material impact on the estimated fair value that we record for share-based payments that we issue. We determine the term of the options based on the simplified method, which averages the vesting period and the contractual life of the stock option. We determine the expected volatility based on the historical volatility of our common stock over a period commensurate with the option’s expected term. The Black-Scholes option pricing model also requires assumptions for risk-free interest rates and the expected dividend yield of our common stock, but we feel that these values are more objective and note that changes in these values do not have a significant impact on the estimated value of the options when compared to the volatility and term assumptions.

 

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We are also required to estimate the level of award forfeitures expected to occur and record compensation expense only for those awards that are ultimately expected to vest. Accordingly, we perform a historical analysis of option awards that are forfeited prior to vesting, and record total stock option expense that reflects this estimated forfeiture rate.

 

Results of Operations

 

Comparison of the Results of Operations for the three Months Ended September 30, 2024 to the three Months Ended September, 2023

 

A comparison of the Company’s operating results for the three months ended September 30, 2024 and 2023, respectively, is as follows.

 

   September 30,
2024
   September 30,
2023
   Variance 
Service Revenue  $-   $70,000   $(70,000)
Total Revenue   -    70,000    (70,000)
Operating expense:               
Research and development   480    21,221    (20,741)
General and administrative   80,277    34,301    45,976 
Goodwill impairment   3,200,000    -    3,200,000 
Total operating expense   3,280,757    55,522    3,225,235 
Loss from operations   (3,280,757)   14,478    (3,295,235)
Interest expense, net   (205,616)   (185,424)   (20,192)
Reimbursement for expenses – related party   -    -    - 
Change in the value of derivatives on debt   114,722    306,836    (192,114)
Loss on debt conversion   -    (94,829)   94,829 
Net income (loss) before controlling interests  $(3,371,651)  $41,061   $(3,412,712)

 

Net Income (Loss)

 

We recorded a net loss of approximately $3.4 million for the three months ended September 30, 2024, as compared to net loss of approximately $41 thousand for the three months ended September 30, 2023. The primary difference in net loss, of approximately $3.4 million, between the three months ended September 30, 2024 as compared to the same period of 2023 was primarily due to higher goodwill impairment of approximately $3.2 million, higher other operating expenses of approximately $30 thousand, higher change in value of derivatives on debt of approximately $0.2 million, and offset by lower loss on debt conversion of approximately $0.1 million, for the three months ended September 30, 2024.

 

Research and Development Expenses

 

Research and development (“R&D”) expenses for the three months ended September 30, 2024 compared to the same period in 2023 were lower by approximately $21 thousand, primarily due to other operational expenses related to OT-101 being borne by the JV.

 

As previously disclosed, and as a result of our JV, we expect our R&D expense to decrease for the remainder of the year 2024, specifically for activities related to OT-101, including the initiation of new clinical trials. Any other development expenses will be subject to our continuing ability to secure sufficient funding to continue planned operations.

 

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General and Administrative Expenses

 

General and administrative (“G&A”) expenses increased by approximately $46 thousand for the three months ended September 30, 2024 compared to the three months ended September 30, 2023, primarily due to higher legal and professional expenses of approximately $140 thousand, offset by lower other expenses by approximately $94 thousand.

 

As previously disclosed and as a result of our JV, we expect our G&A activities to remain steady or marginally increase for the remainder of 2024. Any other G&A expenses will be subject to our continuing ability to secure sufficient funding to continue planned operations.

 

Goodwill Impairment

 

We recorded goodwill impairment of $3.2 million, on the approximately $12.0 million goodwill which we recorded upon our acquisition of PointR, for the three months ended September 30, 2024, compared to no impairment during the three months ended September 30, 2023.

 

During the third quarter of 2024, we observed a decline of our stock price, the market capitalization of our Company, and the general economic conditions, which adversely impacted the majority of the pharmaceutical and biotechnology industry. These were indicative of a potential impairment of our goodwill. While we evaluated and concluded that the AI technologies related to the PointR acquisition are not adversely impacted as the Company continues to develop other AI technologies, the significant reduction of our market capitalization required us to record an impairment on the goodwill to the extent of the difference between the net assets of the Company over the fair value, solely based on the market capitalization, and consistently with the methodology we used during the prior periods.

 

Interest Expense, Net

 

We recorded interest expense, including amortization of debt costs, of approximately $0.2 million for the three months ended September 30, 2024, compared to similar expense for the three months ended September 30, 2023, primarily in connection with debt raised from convertible notes and the JH Darbie Financing, March 2022 and May/June 202 financing. For more information on debt raised from convertible notes and the JH Darbie Financing, see Note 5 and Note 7 of the Unaudited Consolidated Financial Statements of this Quarterly Report.

 

Change in Value of Derivatives

 

During the three months ended September, 2024, we recorded approximately $0.1 million change in value upon conversion of certain debt owed on the convertible promissory notes issued to our CEO and a bridge investor (collectively, the “Convertible Notes”). The Company recorded approximately $0.3 million change during the same period in 2023. The Convertible Notes became convertible 180 days after issuance, and as such the CEO and the bridge investor had the ability to convert that debt into equity at a variable conversion price, giving rise to a derivative feature within the debt instrument resulting in the recording of a derivative liability and change in value of the derivative. For more information on value of derivatives, refer to the Note 5 of the Unaudited Consolidated Financial Statements of this Quarterly Report.

 

Comparison of the Results of Operations for the Nine Months Ended September 30, 2024 to the Nine Months Ended September 30, 2023

 

A comparison of the Company’s operating results for the six months ended September 30, 2024 and 2023, respectively, is as follows.

 

   September 30,
2024
   September 30,
2023
   Variance 
Service Revenue  $-   $70,000   $(70,000)
Total Revenue               
Operating expense:               
Research and development   1,212    50,148    (48,936)
General and administrative   343,347    471,258    (127,911)
Goodwill impairment   3,200,000    6,083,146    (2,883,146)
Total operating expense   3,544,559    6,604,552    (3,059,993)
Loss from operations   (3,544,559)   (6,534,552)   2,989,993 
Interest expense, net   (655,946)   (837,100)   181,154 
Reimbursement for expenses – related party   22,937    72,246    (49,309)
Change in the value of derivatives on debt   140,828    (20,758)   161,586 
Loss on conversion of debt   (88,258)   (94,829)   6,571 
                
Net income (loss) before controlling interests  $(4,124,998)  $(7,414,993)  $3,289,995 

 

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Net Income

 

We recorded a net loss of approximately $4.1 million for the nine months ended September 30, 2024 as compared to a net loss of approximately $7.4 million for the same period ended September 30, 2023. The difference in net loss, of approximately $3.3 million, for the nine months ended September 30, 2024 as compared to the same period of 2023, was primarily due to lower goodwill impairment of approximately $2.8 million, lower operating expense of approximately $0.2 million, lower interest cost of approximately $0.2 million, lower change in value of derivatives on debt of approximately $0.2 million, offset by lower reimbursement of expenses by a related party of approximately $50 thousand and lower service revenue of approximately $70 thousand, compared to the same period in 2024.

 

Research and Development Expenses

 

Research and development (“R&D”) expenses decreased by approximately $48 thousand for the nine months ended September 30, 2024 compared to the same period in 2023, primarily due to reduced operational costs. As a result of our JV with Dragon and GMP Bio, the JV absorbed most of the compensation costs as well as some of the operational costs.

 

As a result of our JV, we expect our R&D expense to decrease for the remainder of the year 2024, specifically for activities related to OT-101, including the initiation of new clinical trials. Any other development expenses will be subject to our continuing ability to secure sufficient funding to continue planned operations.

 

General and Administrative Expenses

 

General and administrative (“G&A”) expenses decreased by approximately $0.1 million for the nine months ended September 30, 2024 compared to the same period ended September 30, 2023, primarily due to lower operational costs.

 

As a result of our JV, we expect our G&A activities to remain steady or marginally increase for the remainder of 2024. Any other G&A expenses will be subject to our continuing ability to secure sufficient funding to continue planned operations.

 

Goodwill Impairment

 

We recorded goodwill impairment of $3.2 million, for the nine months ended September 30, 2024, compared to goodwill impairment of approximately $6.1 million for the nine months ended September 30, 2023, on the approximately $12.0 million goodwill which we recorded upon our acquisition of PointR.

 

During the third quarter of 2024, we observed a further decline of our stock price, the market capitalization of our Company, and the general economic conditions, which adversely impacted the majority of the pharmaceutical and biotechnology industry. These were indicative of a potential impairment of our goodwill. While we evaluated and concluded that the AI technologies related to the PointR acquisition are not adversely impacted as the Company continues to develop other AI technologies, the significant reduction of our market capitalization required us to record an impairment on the goodwill to the extent of the difference between the net assets of the Company over the fair value, solely based on the market capitalization, and consistently with the methodology we used during the prior periods.

 

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Interest Expense, Net

 

We recorded interest expense, including amortization of debt costs, of approximately $0.7 million for the nine months ended September 30, 2024 as compared to $0.8 million for the nine months ended September 30, 2023 primarily in connection with debt raised from convertible notes, JH Darbie Financing, March 2022 and May/June 2022 Financing. Interest expense was lower for the nine months ended September 30, 2024 as compared to the same period of 2023 due to some of the outstanding loans being partially or fully retired. For more information on debt raised from convertible notes and the JH Darbie Financing, see Note 5 and Note 7 of the Unaudited Consolidated Financial Statements of this Quarterly Report.

 

Reimbursement of expenses

 

The Company was reimbursed $23 thousand during the nine months ended September 30, 2024 as compared to approximately $72 thousand, by Autotelic Inc. a related party, on behalf of our JV.

 

Change in Value of Derivatives

 

During the nine months ended September 30, 2023, we recorded approximately $0.1 million gain in value upon conversion of the debt to liabilities as a derivative as well as new debt converting to liabilities on the Convertible Notes as compared to approximately $0.3 million gain during the same period of 2023. The Convertible Notes became convertible 180 days after issuance, and as such Peak One, TFK, the CEO and the bridge investor had the ability to convert that debt into equity at: (i) the variable conversion price of 65% of the Company’s lowest traded price after the first 180 days, or (ii) at the lower of $0.10 per share or 55% of the Company’s traded stock price under certain circumstances. This gave rise to a derivative feature within the debt instrument which resulted in the recording of a derivative liability and change in value of the derivative.

 

Loss on Conversion of Debt

 

During the nine months ended September 30, 2024, we recorded a loss of $0.1 million on conversion of debt. related to the difference in fair value to the price at which the debt was converted, compared to a $0.1 million loss on conversion of debt during the nine months ended September 30, 2023.

 

Liquidity, Financial Condition and Capital Resources ($s in ‘000’s)

 

   September 30, 2024   December 31, 2023 
Cash, including restricted cash of $20  $169   $190 
Working capital   (16,118)   (16,233)
Stockholders’ Equity   8,131    11,611 

 

The Company has experienced net losses every year since inception and as of September 30, 2024 had an accumulated deficit of approximately $37.4 million. As of September 30, 2024, the Company had approximately $0.2 million in cash, and current liabilities of approximately $16.1 million. Of the approximately $16.1 million in current liabilities, of which approximately $1.3 million are net assumed liabilities of the Company as part of the Oncotelic Inc. reverse merger, $4.7 million was debt for conducting clinical trials for OT-101 from GMP and $2.6 million related to contingent liability to issue Common Stock of the Company to PointR shareholders upon achievement of certain milestones. The Company does not expect to generate any meaningful revenue from product sales or licensing in the near future and expects to incur additional operating losses over the next several years, primarily as a result of the Company’s plans to continue clinical trials for its investigational drugs. Since the Company successfully formed the joint venture with Dragon Overseas and GMP Bio, all costs associated with developing the assets licensed to the JV and a substantial portion of the G&A expenses will shift over to the JV and hence the Company may be able to reduce its expenses. The Company’s limited capital resources, history of recurring losses and uncertainties as to whether the Company’s operations will become profitable raise substantial doubt about its ability to continue as a going concern. The financial statements contained in this report do not include any adjustments related to the recoverability of assets or classifications of liabilities that might be necessary should the Company be unable to continue as a going concern.

 

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The principal source of the Company’s working capital deficit to date has been the issuance of convertible notes, a substantial part of which has been provided by officers and certain insiders, and sale of equity under the EPA with Peak One. The Company will need to raise additional capital in order to fund its operations and continue development of product candidates. The Company is evaluating the options to further the development of the Company’s product candidates, AL-101, Artemisinin for COVID-19, developing AI technologies to support the COVID-19 therapies; in addition to evaluating the development pathway of its product candidates; OXi4503 and/or CA4P. The Company is also independently planning to develop OT-101 for certain animal health indications and contemplating using crypto currencies for that platform.

 

The Company anticipates raising substantial additional capital through the sale of equity securities and/or debt, but no other financing arrangements are in place at this time.

 

If the Company is unable to access additional funds when needed, it may not be able to continue the development of these investigational drugs and the Company could be required to delay, scale back or eliminate some or all of its development programs and operations. Any additional equity financing, if available, would be dilutive to the current stockholders and may not be available on favorable terms. Additional debt financing, if available, may involve restrictive covenants and could also be dilutive. The Company’s ability to access capital is not assured and, if access is not achieved on a timely basis, would materially harm the Company’s financial condition, the value of its Common Stock and its business prospects.

 

Cash Flows ($ in ‘000’s) (Pending finalization of SCF)

 

   Nine month ended September 30, 
   2024   2023 
Net cash used in operating activities  $(636)  $(948)
Net cash provided by financing activities   615    975 
Increase (decrease) in cash  $(21)  $27 

 

Operating Activities

 

Net cash used in operating activities was approximately $0.6 million for the nine months ended September 30, 2024. This was due to the net loss of approximately $4.1 million, and primarily offset by approximately $3.2 million of amortization of goodwill, approximately $88 thousand from loss on conversion of debt, approximately $0.1 million of change in fair value of derivative, approximately $0.1 million due to amortization of debt discounts and deferred financing costs and changes in operating assets and liabilities of approximately $0.2 million.

 

Net cash used in operating activities was approximately $0.9 million for the nine months ended September 30, 2023. This was due to the net loss of approximately $7.4 million, primarily offset by non-cash goodwill impairment of approximately $6.1 million, non-cash loss on debt conversion of approximately $0.1 million, change in pair value of derivatives of approximately $21,000 and changes in operating assets and liabilities of approximately $0.3 million.

 

Financing Activities

 

For the nine months ended September 30,2024, net cash provided by financing activities was approximately $0.6 million, primarily due to receipt of a short term loan from a related party.

 

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For the nine months ended September 30,2023, net cash provided by financing activities was approximately $1.0 million, primarily due to short term loans and convertible debt of approximately $1.1 million, offset by repayments to one PPM debt holder and short term loans of approximately $0.1 million

 

Off-Balance Sheet Arrangements

 

We have no off-balance sheet arrangements.

 

Effects of Inflation

 

We do not believe that inflation has had a material impact on our business, revenues or operating results during the periods presented.

 

Contractual Obligations

 

Our current drug development programs are based on a series of compounds called combretastatins, which we have exclusively licensed from Arizona State University, or ASU. If our current drug candidates are approved, we will be required to pay low to mid-single-digit royalties on future net sales of products associated with the ASU patent rights until these patent rights expire.

 

We also have an exclusive license from Bristol-Myers Squibb, or BMS, for certain patent rights to particular combretastatins, including CA4P. If CA4P is approved, we will be required to pay low-single-digit royalties on future net sales of products associated with the BMS patent rights until these patent rights expire.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

Our cash is maintained in U.S. dollar accounts. We have adopted a policy for the cash that we hold, and also for any cash equivalents and investments that we may hold, the primary objective of which is to preserve principal, while also maintaining liquidity to meet our operating needs and maximize yields to the extent possible. Although our investments can be subject to credit risk, we follow procedures to limit the amount of credit exposure in any single issue, issuer or type of investment. Our investments are also subject to interest rate risk and would be likely to decrease in value if market interest rates increase. However, due to the generally conservative nature of our investments and relatively short duration, we believe that interest rate risk is mitigated.

 

Although we may from time-to-time manufacture drugs and conduct preclinical or clinical trials outside of the United States, we believe our exposure to foreign currency risk to be immaterial.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosures. In designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance of achieving the desired control objectives.

 

50

 

 

As required by Rule 13a-15(b) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) our Chief Executive Officer (“CEO”) and our Chief Financial Officer (“CFO”) conducted an evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q, of the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on that evaluation, our CEO and our CFO each concluded that our disclosure controls and procedures are not effective to provide reasonable assurance that information required to be disclosed in the reports that we file or submit under the Exchange Act, (i) is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and (ii) is accumulated and communicated to our management, including our CEO and our CFO, as appropriate to allow timely decisions regarding required disclosure.

 

Material Weaknesses in Internal Control over Financial Reporting

 

Management conducted an assessment of the effectiveness of our internal control over financial reporting as of September 30, 2024 based on the framework established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, management has determined that the Registrant’s internal control over financial reporting as of June 30, 2023 was not effective as a result of certain material weaknesses.

 

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.

 

The ineffectiveness of our internal control over financial reporting was due to the following material weaknesses which are observed in many small companies with a small number of accounting and financial reporting staff:

 

Lack of formal policies and procedures;
Lack of a functioning audit committee and independent directors on the Company’s board of directors to oversee financial reporting responsibilities;
Inadequate or lack of segregation of duties;
Lack of dedicated resources and experienced personnel to design and implement internal control procedures to support financial reporting objectives;
Lack of qualified accounting personnel to prepare and report financial information in accordance with GAAP; and
Lack of risk assessment procedures on internal controls to detect financial reporting risks on a timely manner.

 

Management’s Plan to Remediate the Material Weaknesses

 

Management has been implementing and continues to implement measures designed to ensure that control deficiencies contributing to the material weakness are remediated, such that these controls are designed, implemented, and operating effectively. The remediation actions planned include:

 

Continue to search for, evaluate and recruit qualified independent outside directors;
Hire qualified accounting personnel to prepare and report financial information in accordance with GAAP;
Identify gaps in our skills base and the expertise of our staff required to meet the financial reporting requirements of a public company; and
Continue to develop policies and procedures on internal control over financial reporting and monitor the effectiveness of operations on existing controls and procedures.

 

Changes in Internal Control over Financial Reporting

 

During the nine months ended September 30, 2024, we continued to execute upon our planned remediation actions which are all intended to strengthen our overall control environment. While we have made progress in our planned remediation efforts and we expect the Company to complete its planned execution of internal controls over financial reporting during the year ended December 31, 2023, however, our ability to do so would greatly depend on our ability to obtain financial and other resources to complete the remediation.

 

We are committed to maintaining a strong internal control environment and believe that these remediation efforts will represent significant improvements in our control environment. Our management will continue to monitor and evaluate the relevance of our risk-based approach and the effectiveness of our internal controls and procedures over financial reporting on an ongoing basis and is committed to taking further action and implementing additional enhancements or improvements, as necessary and as funds allow.

 

51

 

 

PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings

 

The Company had disputed a judgement of $20,000 for a non-payment to a third service provider. The Company considered the claim to be immaterial to the financial position of the Company. The Company had filed a counter claim on the third-party service provider as the Company believed the claim to be false and malicious to the interests of the Company. The Honorable Court overruled the previous judgement and the Company had sued the third-party service provider. In March 2024, the Honorable Court’s decision was in favor of the Company due to the reasons described above and the matter has been dismissed. The third party service provider had filed an appeal with the Honorable Court, and the Honorable Court dismissed their appeal.

 

Other claims

 

One of the Company’s ex-employees has made a breach of employment contract claim against the Company. The Company and its legal counsel are evaluating the validity of the claim, as the Company believes that such claim has limited merits and is hopeful to attain a positive outcome for such claim. Since the Company and its legal counsel are still evaluating the claim, we are unable to quantify the amount such claim would be settled at, if at all settled.

 

Item 1A. Risk Factors

 

Please see the risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on April 12, 2024 and other SEC filings. The risks described below and in our 2023 Annual Report on Form 10-K are not the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.

 

Item 2. Unregistered Sales of Equity Securities and Use Of Proceeds

 

In February 2024, Blue Lake partially converted $35,000 of their debt, legal fees and accrued interest. In connection with the partial Note conversion, the Company issued 500,000 shares of Common Stock to Blue Lake.

 

In May 2024, Blue Lake converted the balance of their $531,000 debt (June 2022 note) , inclusive of accrued interest and penalty, into 7,605,760 shares of Common Stock of the Company.

 

Item 3. Defaults upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

Not Applicable.

 

Item 5. Other Information

 

None.

 

52

 

 

ITEM 6. EXHIBITS, FINANCIAL STATEMENT SCHEDULES

 

In reviewing the agreements included as exhibits to this Quarterly Report, please remember that they are included to provide you with information regarding their terms and are not intended to provide any other factual or disclosure information about the Company or the other parties to the agreements. The agreements may contain representations and warranties by each of the parties to the applicable agreement. These representations and warranties have been made solely for the benefit of the parties to the applicable agreement and:

 

  should not in all instances be treated as categorical statements of fact, but rather as a way of allocating the risk to one of the parties if those statements prove to be inaccurate;
     
  have been qualified by disclosures that were made to the other party in connection with the negotiation of the applicable agreement, which disclosures are not necessarily reflected in the agreement;
     
  may apply standards of materiality in a way that is different from what may be viewed as material to you or other investors; and
     
  were made only as of the date of the applicable agreement or such other date or dates as may be specified in the agreement and are subject to more recent developments.

 

Accordingly, these representations and warranties may not describe the actual state of affairs as of the date they were made or at any other time. Additional information about the Company may be found elsewhere in this Quarterly Report and the Company’s other public filings, which are available without charge through the SEC’s website at http://www.sec.gov.

 

The following exhibits are included as part of this Quarterly Report and is not a complete list of all relevant and material agreements. A more complete list of previously filed Exhibits can be found with our 2023Annual Report on Form 10K filed with the SEC on April 12, 2024:

 

        Incorporated by Reference  
Exhibit
Number
  Description   Form   Filing Date   Exhibit Number   Filed Herewith
                     
10.1   Amendment to the Oncotelic Therapeutics, Inc. 2015 Equity Incentive Plan   S-8   4/19/2021   10.1    
                     
10.2   Equity Purchase Agreement by and between Oncotelic Therapeutics, Inc., and Peak One Opportunity Fund, L.P., dated May 3, 2021   8-K   5/7/2021   10.1    
                     
10.3   Registration Rights Agreement, by and between Oncotelic Therapeutics, Inc., and Peak One Opportunity Fund, L.P., dated May 3, 2020   8-K   5/7/2021   10.2    
                     
10.4   Joint Venture Agreement relating to GMP Biotechnology Limited between Dragon Overseas Capital Limited, Oncotelic Therapeutics, Inc. and GMP Biotechnology Limited dated March 31, 2022   8-K   4/6/2022   10.1    

 

53

 

 

10.5   License Agreement between Oncotelic Therapeutics, Inc. and GMP Biotechnology Limited dated March 31, 2022   8-K   4/6/2022   10.2    
                     
10.6   License Agreement between Oncotelic Therapeutics, Inc. and Sapu Holdings, LLC dated March 31, 2022   8-K   4/6/2022   10.3    
                     
10.7   Independent consulting agreement between Oncotelic Therapeutics, Inc. and Fatih Uckun, MD, Ph.D. dated May 1, 2022   8-K   5/6/2022   10.1    
                     
10.8   Independent consulting agreement between Oncotelic Therapeutics, Inc. and Seymour Fein, MD dated May 1, 2022   8-K   5/6/2022   10.2    
                     
10.9   Securities Purchase Agreement between Oncotelic Therapeutics Inc. and certain accredited investors dated May 27, 2022   8-K   6/3/2022   10.1    
                     
10.10   Securities Purchase Agreement between Oncotelic Therapeutics Inc. and certain accredited investors dated June 22, 2022   8-K   6/27/2022   10.1    
                     
10.11   Amended and Restated By-Laws   8-K   05/19/2023   3.2    
                     
10.12   Form of Subscription Agreement   8-K   07/13/2023   10.1    
                     
10.13   Form of warrant   8-K   07/13/2023   10.3    
                     
10.14   Form of note   8-K   07/13/2023   10.4    
                     
10.15   Form of Subscription Agreement   8-K   02/02/2024   10.1    
                     
31.1   Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a).               x
                     
31.2   Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a).               x
                     
32.1   Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.               x
                     
32.2   Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.               x
                     
101.1   Interactive Data Files for the Three and Six months ended June 20, 2024 and June 30, 2023               x
                     
101.INS   Inline XBRL Instance Document               x
                     
101.SCH   Inline XBRL Taxonomy Extension Schema               x
                     
101.CAL   Inline XBRL Taxonomy Extension Calculation Linkbase               x
                     
101.DEF   Inline XBRL Taxonomy Extension Definition Linkbase               x
                     
101.LAB   Inline XBRL Taxonomy Extension Label Linkbase               x
                     
101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase               x
                     
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)               x

 

* Confidential treatment has been granted for portions of this Exhibit. Redacted portions filed separately with the Securities and Exchange Commission.
   
+ Management contract or compensatory plan or arrangement.

 

54

 

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

ONCOTELIC THERPAEUTICS INC.

 

By: /s/ Vuong Trieu  
  Vuong Trieu, Ph.D.  
  Chief Executive Officer and Director (Principal Executive Officer)  
     
Date: November 19, 2024  
     
By: /s/ Amit Shah  
  Amit Shah  
 

Chief Financial Officer

(Principal Financial and Accounting Officer)

 
     
Date: November 19, 2024  

 

55

 

 

Exhibit 31.1

 

ONCOTELIC THERAPEUTICS, INC.

CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Vuong Trieu, Ph.D., certify that:

 

  1. I have reviewed this Quarterly Report on Form 10-Q of Oncotelic Therapeutics, Inc. for the period ended September 30, 2024;
     
  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
     
  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
     
  4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a–15(e) and 15d–15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have:

 

  (a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     
  (b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     
  (c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
  (d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

  5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     
  (b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

By: /s/ Vuong Trieu  
  Vuong Trieu, Ph.D.  
  Chief Executive Officer (Principal Executive Officer)  
     
Date: November 19, 2024  

 

 

 

Exhibit 31.2

 

ONCOTELIC THERAPEUTICS, INC.

CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Amit Shah, certify that:

 

  1. I have reviewed this Quarterly Report on Form 10-Q of Oncotelic Therapeutics, Inc. for the period ended September 30, 2024;
     
  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
     
  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
     
  4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a–15(e) and 15d–15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have:

 

  (a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     
  (b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     
  (c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
  (d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

  5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     
  (b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

By: /s/ Amit Shah  
  Amit Shah  
  Chief Financial Officer (Principal Financial and Accounting Officer)  
     
Date: November 19, 2024  

 

 

 

Exhibit 32.1

 

ONCOTELIC THERAPEUTICS, INC.

CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with this Quarterly Report on Form 10-Q for the period ended September 30, 2024 of Oncotelic Therapeutics, Inc. (the “Company”) as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, in the capacity and on the date indicated below, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:

 

1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operation of the Company.

 

By: /s/ Vuong Trieu  
  Vuong Trieu, Ph.D.  
  Chief Executive Officer (Principal Executive Officer)  
     
Date: November 19, 2024  

 

 

 

Exhibit 32.2

 

ONCOTELIC THERAPEUTICS, INC.

CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with this Quarterly Report on Form 10-Q for the period ended September 30, 2024 of Oncotelic Therapeutics, Inc. (the “Company”) as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, in the capacity and on the date indicated below, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:

 

1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operation of the Company.

 

By: /s/ Amit Shah  
  Amit Shah  
  Chief Financial Officer (Principal Financial and Accounting Officer)  
     
Date: November 19, 2024  

 

 
v3.24.3
Cover - shares
9 Months Ended
Sep. 30, 2024
Nov. 18, 2024
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Quarterly Report true  
Document Transition Report false  
Document Period End Date Sep. 30, 2024  
Document Fiscal Period Focus Q3  
Document Fiscal Year Focus 2024  
Current Fiscal Year End Date --12-31  
Entity File Number 000-21990  
Entity Registrant Name Oncotelic Therapeutics, Inc.  
Entity Central Index Key 0000908259  
Entity Tax Identification Number 13-3679168  
Entity Incorporation, State or Country Code DE  
Entity Address, Address Line One 29397 Agoura Road Suite 107  
Entity Address, City or Town Agoura Hills  
Entity Address, State or Province CA  
Entity Address, Postal Zip Code 91301  
City Area Code (650)  
Local Phone Number 635-7000  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   407,289,618
v3.24.3
Consolidated Balance Sheets (Unaudited) - USD ($)
Sep. 30, 2024
Dec. 31, 2023
Current assets:    
Cash $ 149,018 $ 170,405
Restricted cash 20,000 20,000
Accounts receivable 18,976 18,976
Prepaid & other current assets 51,036 62,356
Total current assets 239,030 271,737
In process R&D 1,101,760 1,101,760
Goodwill, net of impairment 2,788,230 5,988,230
Investment in GMP Bio at fair value 22,653,225 22,653,225
Total assets 26,782,245 30,014,952
Current liabilities:    
Accounts payable and accrued liabilities 2,462,123 2,437,321
Contingent consideration 2,625,000 2,625,000
Derivative liability on notes 282,386 423,214
Total current liabilities 16,357,380 16,504,947
Total noncurrent liabilities 2,292,893 1,898,468
Total liabilities 18,650,273 18,403,415
Commitments and contingencies (Note 14)
Stockholders’ equity:    
Common stock, $.01 par value; 750,000,000 shares authorized; 407,289,618 and 399,184,128 issued and outstanding, respectively 4,072,899 3,991,839
Additional paid-in capital 42,219,400 41,655,026
Accumulated deficit (37,439,735) (33,516,736)
Total Oncotelic Therapeutics, Inc. stockholders’ equity 8,852,564 12,130,129
Non-controlling interests (720,592) (518,592)
Total stockholders’ equity 8,131,972 11,611,537
Total liabilities and stockholders’ equity 26,782,245 30,014,952
Related Party [Member]    
Current liabilities:    
Accounts payable - related party 345,543 344,099
Convertible debt and short-term debt, net of costs 2,898,392 2,608,356
Convertible long-term debt, net of costs 125,000
Nonrelated Party [Member]    
Current liabilities:    
Convertible debt and short-term debt, net of costs 7,743,936 8,066,957
Convertible long-term debt, net of costs $ 2,167,893 $ 1,898,468
v3.24.3
Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
Sep. 30, 2024
Dec. 31, 2023
Statement of Financial Position [Abstract]    
Common stock, par value $ 0.01 $ 0.01
Common stock, shares authorized 750,000,000 750,000,000
Common stock, shares issued 407,289,618 399,184,128
Common stock, shares outstanding 407,289,618 399,184,128
v3.24.3
Consolidated Statements of Operations (Unaudited) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Total Revenue $ 70,000 $ 70,000
Operating expenses:        
Research and development 480 21,221 1,212 50,148
General and administrative 80,277 34,301 343,347 471,258
Goodwill impairment (See note 2 and 3) 3,200,000 3,200,000 6,083,146
Total operating expenses 3,280,757 55,522 3,544,559 6,604,552
Income/(Loss) from operations (3,280,757) 14,478 (3,544,559) (6,534,552)
Other income (expense):        
Interest expense, net (205,616) (185,424) (655,946) (837,100)
Reimbursement for expenses - related party 22,937 72,246
Change in fair value of derivative on debt 114,722 306,836 140,828 (20,758)
Loss on debt conversion (94,829) (88,258) (94,829)
Total other income (expense) (90,894) 26,583 (580,439) (880,441)
Net income (loss) before non-controlling interests (3,371,651) 41,061 (4,124,998) (7,414,993)
Net loss attributable to non-controlling interests (67,165) (74,248) (202,000) (247,883)
Net income (loss) attributable to Oncotelic Therapeutics, Inc. $ (3,304,486) $ 115,309 $ (3,922,998) $ (7,167,110)
Basic net loss per share attributable to common stock $ (0.01) $ 0.00 $ (0.01) $ (0.02)
Basic weighted average common stock outstanding 407,289,888 397,777,882 403,428,494 395,237,893
Diluted net loss per share attributable to common stock $ (0.01) $ 0.00 $ (0.01) $ (0.02)
Diluted weighted average common stock outstanding 407,289,888 397,777,882 403,428,494 395,237,893
Service [Member]        
Total Revenue $ 70,000 $ 70,000
v3.24.3
Consolidated Statement of Stockholders' Equity (Unaudited) - USD ($)
Preferred Stock [Member]
Common Stock [Member]
Additional Paid-in Capital [Member]
Retained Earnings [Member]
Noncontrolling Interest [Member]
Total
Balance at Dec. 31, 2022 $ 3,918,469 $ 41,416,632 $ (25,926,069) $ (215,620) $ 19,193,412
Balance, shares at Dec. 31, 2022 391,846,880        
Common shares issued in connection with debt conversion   $ 10,250 61,499 71,749
Common shares issued in connection with debt conversion, shares   1,025,000        
Net income (loss)     (525,419) (80,625) (606,044)
Adpotion of ASU 2020-06     (521,749) 312,426   (209,323)
Balance at Mar. 31, 2023 $ 3,928,719 40,956,382 (26,139,062) (296,245) 18,449,794
Balance, shares at Mar. 31, 2023 392,871,880        
Balance at Dec. 31, 2022 $ 3,918,469 41,416,632 (25,926,069) (215,620) 19,193,412
Balance, shares at Dec. 31, 2022 391,846,880        
Net income (loss)           (7,414,993)
Balance at Sep. 30, 2023 $ 3,981,589 41,348,213 (32,780,753) (463,503) 12,085,546
Balance, shares at Sep. 30, 2023 398,159,128        
Balance at Mar. 31, 2023 $ 3,928,719 40,956,382 (26,139,062) (296,245) 18,449,794
Balance, shares at Mar. 31, 2023 392,871,880        
Common shares issued in connection with debt conversion $ 46,597 279,566 326,163
Common shares issued in connection with debt conversion, shares   4,659,710        
Net income (loss) (6,757,000) (93,010) (6,850,010)
Balance at Jun. 30, 2023 $ 3,975,316 41,235,948 (32,896,062) (389,255) 11,925,947
Balance, shares at Jun. 30, 2023 397,531,590        
Common shares issued in connection with debt conversion $ 6,273 28,994   35,267
Common shares issued in connection with debt conversion, shares   627,538        
Net income (loss) 115,309 (74,248) 41,061
Loss on extinguishment of PPM debt     98,429     98,429
Allocation of cost of warrants for PPM Debt     (15,158)     (15,158)
In connection with debt debt conversion    
Balance at Sep. 30, 2023 $ 3,981,589 41,348,213 (32,780,753) (463,503) 12,085,546
Balance, shares at Sep. 30, 2023 398,159,128        
Balance at Dec. 31, 2023 $ 3,991,839 41,655,026 (33,516,736) (518,592) 11,611,537
Balance, shares at Dec. 31, 2023 399,184,128        
Common shares issued in connection with debt conversion $ 5,000 108,029   113,029
Common shares issued in connection with debt conversion, shares   500,000        
Net income (loss)       (408,676) (66,499) (475,175)
Balance at Mar. 31, 2024 $ 3,996,839 41,763,055 (33,925,412) (585,091) 11,249,391
Balance, shares at Mar. 31, 2024 399,684,128        
Balance at Dec. 31, 2023 $ 3,991,839 41,655,026 (33,516,736) (518,592) 11,611,537
Balance, shares at Dec. 31, 2023 399,184,128        
Net income (loss)           (4,124,998)
Balance at Sep. 30, 2024 $ 4,072,899 42,219,400 (37,439,735) (720,592) 8,131,972
Balance, shares at Sep. 30, 2024 407,289,888        
Balance at Mar. 31, 2024 $ 3,996,839 41,763,055 (33,925,412) (585,091) 11,249,391
Balance, shares at Mar. 31, 2024 399,684,128        
Common shares issued in connection with debt conversion   $ 76,060 456,345     532,405
Common shares issued in connection with debt conversion, shares   7,605,760        
Net income (loss)     (209,837) (68,336) (278,173)
Balance at Jun. 30, 2024 $ 4,072,899 42,219,400 (34,135,249) (653,427) 11,503,623
Balance, shares at Jun. 30, 2024 407,289,888        
Net income (loss) (3,304,486) (67,165) (3,371,651)
Balance at Sep. 30, 2024 $ 4,072,899 $ 42,219,400 $ (37,439,735) $ (720,592) $ 8,131,972
Balance, shares at Sep. 30, 2024 407,289,888        
v3.24.3
Consolidated Statements of Cash Flows (Unaudited) - USD ($)
3 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2024
Mar. 31, 2024
Sep. 30, 2023
Mar. 31, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Cash flows from operating activities:              
Net income (loss) $ (3,371,651) $ (475,175) $ 41,061 $ (606,044) $ (4,124,998) $ (7,414,993)  
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:              
Goodwill impairment 3,200,000     3,200,000 6,083,146 $ 6,083,146
Amortization of debt discount and deferred finance costs         117,132  
Change in fair value of derivative (114,722)   (306,836)   (140,828) 20,758  
Loss on debt conversion   94,829   88,258 94,829  
Changes in operating assets and liabilities:              
Prepaid expenses and other current assets         11,320 (39,768)  
Accounts payable and accrued expenses         211,285 367,348  
Accounts payable to related party         1,444 (59,750)  
Net cash used in operating activities         (636,387) (948,430)  
Cash flows from financing activities:              
Proceeds from / (repayment to) private placement         (100,000)  
Proceeds from convertible notes and short term loans, others         615,000 1,110,000  
Repaid to others         (35,000)  
Net cash provided by financing activities         615,000 975,000  
Net increase (decrease) in cash         (21,387) 26,570  
Cash and restricted cash - beginning of period   $ 190,405   $ 261,452 190,405 261,452 261,452
Cash and restricted cash - end of period $ 169,018   $ 288,022   169,018 288,022 $ 190,405
Supplemental cash flow information:              
Interest paid         281,260 296,186  
Non-cash investing and financing activities:              
Warrants issued in connection with private placement         83,271  
Common shares issued upon partial conversion of debt         645,434 433,179  
Beneficial Conversion Feature on convertible debt and restricted common shares         $ (209,323)  
v3.24.3
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION

NOTE 1 – DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION

 

Description of Business

 

Oncotelic Therapeutics, Inc. (“Oncotelic”), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic conducts business activities through Oncotelic and its wholly owned subsidiaries, Oncotelic, Inc., a Delaware corporation, PointR Data, Inc. (“PointR”), a Delaware corporation; Pet2DAO, Inc (“Pet2DAO”) and EdgePoint AI, Inc. (“Edgepoint”), a Delaware Corporation for which there are non-controlling interests, (Oncotelic, Oncotelic Inc., PointR, Pet2DAO and Edgepoint are collectively called the “Company” or “We”). The Company completed a reverse merger with Oncotelic Inc in April 2019, a merger with PointR in November 2019 and formed a subsidiary Edgepoint in February 2020. For more information on these mergers, refer to our 2022 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

The Company is currently developing OT-101, through its joint venture (“JV”) with Dragon Overseas Capital Limited (“Dragon”) and GMP Biotechnology Limited (“GMP Bio”), both affiliates of Golden Mountain Partners (“GMP”), for various cancers and COVID-19, Artemisinin for COVID-19 and AI technologies for clinical development and manufacturing. The Company is also independently planning to develop OT-101 for certain animal health indications and contemplating using crypto currencies for that platform. The Company acquired apomorphine for Parkinson’s Disease, erectile dysfunction and female sexual dysfunction. In addition, the Company is evaluating the further development of its product candidates OXi4503, as a treatment for acute myeloid leukemia and myelodysplastic syndromes, and CA4P, in combination with a checkpoint inhibitor for the treatment of advanced metastatic melanoma.

 

The Company is primarily a cancer immunotherapy company dedicated to the development of first in class self-immunization protocol (“SIP™”) candidates for difficult to treat cancers. The Company’s proprietary SIP™ candidates are expected to offer advantages over other immunotherapies because they do not require extraction of the tumor or isolation of the antigens, and they have the potential for broad-spectrum applicability for multiple cancer types. The Company’s proprietary product candidates have shown promising clinical activity in phase 2 trials for the treatment of gliomas and pancreatic cancers. The Company aims to translate its unique insights, which span more than three decades of original work using RNA therapeutics, into the deployment of antisense as a RNA therapeutic for diseases which are caused by TGF-β overexpression, starting with cancer and expanding to Duchenne Muscular Dystrophy (“DMD”) and others. OT-101, is being developed as a broad-spectrum anti-cancer drug that can also be used in combination with other standard cancer therapies to establish an effective multi-modality treatment strategy for difficult-to-treat cancers. The JV plans to initiate phase 2 and 3 clinical trials for OT-101 in both high-grade glioma and pancreatic cancer, and any other indications that may evolve, for human pharmaceutical needs. The JV may also be sponsoring investigator-initiated studies for OT-101 for other oncology indications. The Company is evaluating the further development of its product candidates OXi4503, as a treatment for acute myeloid leukemia and myelodysplastic syndromes, and CA4P, in combination with a checkpoint inhibitor for the treatment of advanced metastatic melanoma. The JV is also developing OT-101 for the various epidemics and pandemics, similar to the corona virus (“COVID-19”) pandemic. In this connection, the Company entered into an agreement and supplemental agreement with GMP for a total of $1.2 million to render services and was paid for the development of OT-101. The Company was working with the Biomedical Advanced Research and Development Authority (“BARDA”) to conduct an observational study to evaluate the effects of long COVID-19 and had been provided a grant of up to $0.75 million for the study; however, BARDA discontinued that program with the Company. In 2020 and 2021, the Company was developing Artemisinin as a potential therapy for COVID-19. Artemisinin, purified from a plant Artemisia annua. For more information on GMP and Artemisinin, refer to our 2023 Annual report on Form 10- K filed with the SEC on April 12, 2024.

 

 

Fundraising

 

Private Placement 2 & JH Darbie Financing

 

Between July 2023 and September 2023, the Company entered into a series of subscription agreements with 15 accredited investors which resulted in a conversion of a gross amount of $1.0 million, consisting of 40 notes, under the prior JH Darbie Financing into new debt to the Company. JH Darbie and the Company are parties to a March 2023 placement agent agreement (“Agreement”) pursuant to which JH Darbie has the right to sell/convert a minimum of 10 Units and a maximum of 200 Units on a best-efforts basis. Further, in October 2023, the Company entered into a series of subscription agreements with 27 accredited investors which resulted in a conversion of a gross amount of $1.05 million, consisting of 42 notes, under the prior JH Darbie Financing into new debt to the Company. Additionally, in January 2024, Company entered into a series of subscription agreements with 4 accredited investors which resulted in a conversion of a gross amount of $0.3 million, consisting of 12 notes. The July 2023, October 2023 and January 2024 conversions fully converted JH Darbie PPM-1 notes into PPM-2 notes. For more information on the new JH Darbie Financing, refer to Note 8 of these Notes to the Consolidated Financial Statements.

 

J.H. Darbie Financing Notes & Issuance of Oncotelic Warrants

 

In February 2022, the Company and 99 out of 100 of the Investors agreed to extend the maturity date of the notes connected to the Units from March 31, 2022 to March 31, 2023. In addition, the Company issued approximately 33 million warrants to purchase $50,000 of shares of common stock of the Company (“Common Stock’) in connection with agreeing to extend the maturity date by one year. The issuance of the additional warrants resulted in the Company recording an expense of approximately $2.9 million in the Company’s statement of operations during the year ended December 31, 2022. The approximately 33 million warrants to purchase shares of our Common Stock expired on March 31, 2024. For more information on the JD Darbie financing, refer to Note 7 of these unaudited Notes to the Consolidated Financial Statements.

 

Equity Purchase Agreement

 

In May 2021, the Company entered into an Equity Purchase Agreement (the “EPL”) and Registration Rights Agreement (the “Registration Rights Agreement”) with Peak One Opportunity Fund, L.P. (“Peak One”), pursuant to which the Company shall have the right, but not the obligation, to direct Peak One to purchase up to $10.0 million (the “Maximum Commitment Amount”) in shares of the common stock, par value $0.01 per share (“Common Stock”) in multiple tranches. The Company filed a post-effective amendment for the EPL on April 12, 2024 with the SEC and the SEC has made the post-effective amendment effective on April 22, 2024. The Company filed a prospectus under rule 424b3 with the SEC on April 26, 2024. For more information on the EPL, refer to Note 10 of the Notes to the Unaudited Consolidated Financial Statements.

 

 

August 2021 Notes

 

In August 2021, the Company issued Note Purchase Agreements with Autotelic Inc., the Company’s Chief Financial Officer (“CFO”), and certain other accredited investors. Under the terms of the Note Purchase Agreements, the Company issued an aggregate of $698,500 (the “Principal Amount”) in debt in the form of unsecured convertible promissory notes (collectively, the “Notes”). The Notes are unsecured, and provide for interest at the rate of 5% per annum. For more information on the debt financing of the Company, refer to Note 5 of the Notes to the Consolidated Financial Statements.

 

November-December 2021 and March 2022 Notes

 

In November / December 2021, the Company entered into various Securities Purchase Agreements with Talos Victory Fund, LLC (the (“Talos”), Mast Hill Fund, LP (“Mast”), FirstFire Global Opportunities Fund, LLC (“FirstFire”), Blue Lake Partners, LLC (“Blue Lake”) and Fourth Man, LLC (“Fourth Man”), pursuant to which the Company issued convertible promissory notes in the aggregate principal amount of $0.25 million each, aggregating gross $1.25 million (the “Notes”), and which Notes were convertible into shares of the Company’s common stock, par value $0.01 per share (“Common Stock”). In June 2022, Mast fully converted their November 2021 Note, for which the company issued 4,025,000 shares of Common Stock. Further, during the year ended December 31, 2023, the Company fully converted the balance of Fourth Man convertible note of approximately $127,000 into 1,820,395 shares of the Company’s common stock, which fully retired the convertible note as of September 30, 2024.

 

In March 2022, the Company entered into a Securities Purchase Agreement with Fourth Man, pursuant to which the Company issued convertible promissory note in the aggregate principal amount of $0.25 million, which Note is convertible into shares of the Company’s Common Stock. As of June 30, 2024, this note was in default and available for conversion into the Company’s Common Stock due to cross default provision contained in November / December 2021 Notes. During the nine months ended September 30, 2024, Fourth Man converted a portion of the March 2022 debt, including interest, and conversion fee, of approximately $35,000 for 500,000 shares of the Company’s Common Stock.

 

For more information on the debt financing of the Company, refer to Note 5 of the Notes to the Consolidated Financial Statements.

 

May 2022 Note

 

In May 2022, the Company entered into a Securities Purchase Agreement with Mast, pursuant to which the Company issued convertible promissory notes in the aggregate principal amount of $0.6 million, which note is convertible into shares of the Company’s Common Stock. In May 2024, the May 2022 Note was extended till May 27, 2025, at a cost of 10% of the outstanding Note amount, including interest and penalty. For more information on the debt financing of the Company, refer to Note 5 of the Notes to the Consolidated Financial Statements.

 

June 2022 Note

 

In June 2022, the Company entered into a Securities Purchase Agreement with Blue Lake, pursuant to which the Company issued convertible promissory notes in the aggregate principal amount of $0.34 million, which note was convertible into shares of the Company’s Common Stock. During the nine months ended September 30, 2024, Blue Lake converted the balance of their debt, including accrued interest and penalty, of approximately $531,000 for approximately 7.6 million shares of the Company’s Common Stock.

 

For more information on the debt financing of the Company, refer to Note 5 of the Notes to the Consolidated Financial Statements.

 

 

Forever Prosperity (previously GMP) Note purchase agreements and unsecured notes

 

Between June 2020 and January 2022, the Company entered into various purchase agreements and promissory notes with GMP, cumulatively totaling $4.5 million. Such notes were assigned to Forever Prosperity, LLC, an affiliated entity of GMP.

 

For more information on the GMP debt financing, refer to Note 5 of the Notes to the Consolidated Financial Statements.

 

Joint Venture with GMP Bio

 

In March 2022, the Company formalized a joint venture (“JV”) with Dragon Overseas Capital Limited (“Dragon”) and GMP Biotechnology Limited (“GMP Bio”), both affiliates of GMP. Although no assurances can be given, the Company and GMP currently intend to conduct an initial public offering of the JV, at a future date, on either the Hong Kong Exchange or other stock exchange.

 

For more information on the JV, refer to Note 6 of the unaudited Notes to the Consolidated Financial Statements.

 

Pet2DAO

 

In November 2022, the Company formed a Decentralized autonomous organization (“DAO”) entity, Pet2DAO LLC (“Pet2DAO”), as a wholly owned subsidiary.

 

For more information on Pet2DAO, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

Mosaic ImmunoEngineering, Inc. Term Sheet

 

In April 2024, the Company entered into a binding term sheet (the “Term Sheet”) with Mosaic ImmunoEngineering, Inc. (“Mosaic”). For more information on the Term Sheet, refer to the Current Report on Form 8-K filed with the SEC on April 29, 2024. In August 2024, Mosaic and the Company mutually agreed to extend the date of the Term Sheet to expire at the earlier of (1) the signing of definitive agreements or (2) December 31, 2024. This was to allow for both Companies to complete due diligence as well as agree and finalize the definitive agreements.

 

Licensing Agreement with Autotelic Inc.

 

In September 2021, the Company entered into an exclusive License Agreement (the “Agreement”) with Autotelic, Inc. (“Autotelic”). For more information on the Agreement, refer to our 2023 10-K filed with the SEC on April 12, 2024.

 

Principles of Consolidation

 

The consolidated financial statements include the accounts of Oncotelic, its wholly owned subsidiaries, Oncotelic Inc. and PointR, and Edgepoint our non-controlled interest entity. Intercompany accounts and transactions have been eliminated in consolidation.

 

Basis of Presentation

 

The accompanying consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission including Form 10-K and Regulation S-X.

 

 

Liquidity and Going Concern

 

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The Company has incurred net accumulated losses of approximately $37.4 million since inception of Oncotelic Inc., as the Company’s historical financial statements before the Merger have been replaced with the historical financial statements of Oncotelic Inc. The Company also has a negative working capital of approximately $16.1 million at September 30, 2024, of which approximately $2.6 million contingent liability of issuance of common shares of the Company to PointR shareholders upon achievement of certain milestones in accordance with the PointR Merger Agreement. The Company has negative cash flows from operations for the nine months ended September 30, 2024 of approximately $0.6 million. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the date of this filing Management expects to incur significantly lower costs and losses in the foreseeable future, as a majority of the costs related with the development of OT-101 will be incurred by the JV, but the Company also recognizes the need to raise capital to remain viable. The accompanying consolidated financial statements do not include any adjustments that might be necessary should the Company be unable to continue as a going concern.

 

The Company’s long-term plans include continued development of its current pipeline of products, in addition to continue the development of OT-101 which is exclusively out-licensed to the JV and the JV will be responsible for the funding required to support the development in entirety, to generate sufficient revenues, through either technology transfer or product sales, or raise additional financing to cover its anticipated expenses. Until the Company is able to generate sufficient revenues from its current pipeline, the Company plans on funding its operations through the sale of equity and/or the issuance of debt, combined with or without warrants or other equity instruments.

 

The Company obtained short terms loans of approximately $0.6 million from Autotelic Inc., a related party, during the nine months ended September 30, 2024. In addition, the Company obtained a short-term loan of $15 thousand from Amit Shah, it’s CFO during the nine months ended September 30, 2024.

 

Although no assurances can be given as to the Company’s ability to deliver on its revenue plans, or that unforeseen expenses may arise, management believes that the potential equity and debt financing or other potential financing will provide the necessary funding for the Company to continue as a going concern. Also, management cannot guarantee any potential debt or equity financing will be available on favorable terms or at all. As such, management does not believe the Company has sufficient cash for 12 months from the date of this report. If adequate funds are not available on acceptable terms, or at all, the Company will need to curtail operations, or cease operations completely.

 

v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Use of Estimates

 

The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, equity-based transactions and disclosure of contingent liabilities at the date of the financial statements and revenues and expense during the reporting period. Actual results could materially differ from those estimates.

 

The Company believes the following critical accounting policies affect its more significant judgments and estimates used in the preparation of the financial statements. Significant estimates include the valuation of goodwill and intangible assets for impairment, deferred tax asset and valuation allowance, and fair value of financial instruments.

 

Cash

 

As of September 30, 2024, and December 31, 2023 the Company held all its cash in banks. The Company considers investments in highly liquid instruments with a maturity of three months or less to be cash equivalents. The Company did not have any cash equivalents as of September 30, 2024 and December 31, 2023, respectively. Restricted cash consists of certificates of deposits held at banks as collateral.

 

 

Debt issuance Costs and Debt discount

 

Issuance costs are specific incremental costs that are (1) paid to third parties and (2) directly attributable to the issuance of a debt or equity instrument. The issuance costs attributable to the initial sale of the instrument are offset against the associated proceeds in the determination of the instrument’s initial net carrying amount.

 

Debt issuance costs and debt discounts are being amortized over the lives of the related financings on a basis that approximates the effective interest method. Costs and discounts are presented as a reduction of the related debt in the accompanying balance sheets if related to the issuance of debt or presented as a reduction of additional paid in capital if related to the issuance of an equity instrument. The Company applies the relative fair value to allocate the issuance costs among freestanding instruments that form part of the same transaction.

 

If the Company amends the terms of its convertible notes, the Company reviews and applies the guidance per ASC 470-60 Troubled debt restructurings and ASC 470-50 Debt-Modifications and Extinguishments, evaluates and concludes whether the terms of the agreements were or were not substantially different as of a particular reporting date and accounts the transaction as a debt modification or a troubled debt restructuring.

 

Fair Value of Financial Instruments

 

The carrying value of cash, accounts payable and accrued expense approximate their fair values based on the short-term maturity of these instruments. As defined in ASC 820, “Fair Value Measurements and Disclosures,” fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company utilizes market data or assumptions that market participants would use in pricing the asset or liability, including assumptions about risk and the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market corroborated, or generally unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurement) and the lowest priority to unobservable inputs (level 3 measurement). This fair value measurement framework applies at both initial and subsequent measurement.

 

The three levels of the fair value hierarchy defined by ASC 820 are as follows:

 

Level 1 – Quoted prices are available in active markets for identical assets or liabilities as of the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis. Level 1 primarily consists of financial instruments such as exchange-traded derivatives, marketable securities and listed equities.
   
Level 2 – Pricing inputs are other than quoted prices in active markets included in Level 1, which are either directly or indirectly observable as of the reported date. Level 2 includes those financial instruments that are valued using models or other valuation methodologies. These models are primarily industry-standard models that consider various assumptions, including quoted forward prices for commodities, time value, volatility factors and current market and contractual prices for the underlying instruments, as well as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace throughout the full term of the instrument, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. Instruments in this category generally include non-exchange-traded derivatives such as commodity swaps, interest rate swaps, options and collars.
   
Level 3 – Pricing inputs include significant inputs that are generally less observable from objective sources. These inputs may be used with internally developed methodologies that result in management’s best estimate of fair value.

 

The Company did not have any Level 1 or Level 2 assets and liabilities at September 30, 2024 and December 31, 2023.

 

 

Investment in equity securities

 

The following table summarizes the cumulative gross unrealized gains and losses and fair values for long-term investments accounted for at fair value under the fair value option, with the unrealized gains and losses reported within earnings on the Condensed Consolidated Statements of Operation as of September 30, 2024 and December 31, 2023:

 

   Initial Book Value  

Cumulative Gross

Unrealized Gains

  

Cumulative Gross

Unrealized Losses

   Fair Value 
September 30, 2024                    
Investment in GMP Bio (equity securities)  $22,653,225   $                  -   $                       -   $22,653,225 
Total  $22,653,225   $-   $-   $22,653,225 

 

   Initial Book Value  

Cumulative Gross

Unrealized Gains

  

Cumulative Gross

Unrealized Losses

   Fair Value 
December 31, 2023                    
Investment in GMP Bio (equity securities)  $22,640,521   $12,704   $                       -   $22,653,225 
Total  $22,640,521   $12,704   $-   $22,653,225 

 

The table above sets forth a summary of the recording of the initial value of the long-term value of investment in equity securities of GMP Bio, based on a third-party valuation report, and changes in the fair value of such equity securities, if such change occurs, as a Level 3 fair value as of September 30, 2024 and December 31, 2023. During the nine months ended September 30, 2024, there have been no changes in the long-term value of the investment in equity securities of GMP Bio.

 

Derivative Liability

 

The Company has certain derivative liabilities associated with its 2019 bridge financing Convertible Notes (see Note 5), which consisted of conversion feature derivatives at September 30, 2024 and December 31, 2023, are Level 3 fair value measurements.

 

The table below sets forth a summary of the changes in the fair value of the Company’s derivative liabilities classified as Level 3 as of September 30, 2024 and December 31, 2023:

 

  

September 30, 2024

Conversion Feature

  

December 31, 2023

Conversion Feature

 
Balance at January 1, 2024 and 2023  $423,214   $198,140 
New derivative liability   -    - 
Reclassification to additional paid in capital from conversion of debt to common stock   -    - 
Change in fair value   (140,828)   225,074 
           
Balance at September 30, 2024 and December 31, 2023  $282,386   $423,214 

 

 

As of September 30, 2024, and December 31, 2023, the Company estimated the fair value of the conversion feature derivatives embedded in the convertible debentures based on assumptions used in the Black-Scholes valuation model. The key valuation assumptions used consists, in part, of the price of the Company’s Common Stock, a risk-free interest rate based on the yield of a Treasury note and expected volatility of the Company’s Common Stock all as of the measurement dates. The Company used the following assumptions to estimate fair value of the derivatives as of September 30, 2024 and December 31, 2023, respectively:

 

   September 30, 2024   December 31, 2023 
   Key   Key 
   Assumptions   Assumptions 
   for fair value   for fair value 
   of conversions   of conversions 
Risk free interest   3.98% - 5.09 %   4.64% - 5.40%
Market price of share  $0.02 - 0.04   $0.03 - 0.05 
Life of instrument in years   0.01    0.01 
Volatility   161.5% - 226.9%   142.45%-236.86%
Dividend yield   0%   0%

 

When the Company changes its valuation inputs for measuring financial liabilities at fair value, either due to changes in current market conditions or other factors, it may need to transfer those liabilities to another level in the hierarchy based on the new inputs used. The Company recognizes these transfers at the end of the reporting period that the transfers occur. For the periods ended September 30, 2024 and 2023, respectively, there were no transfers of financial assets or financial liabilities between the hierarchy levels.

 

The $2,625,000 of contingent consideration, of shares issuable to PointR shareholders which was recorded and associated with the PointR Merger, is also classified as Level 3 fair value measurements. The Company initially recorded the contingency based on a valuation conducted by a third-party valuation expert. The valuation was based on a probability of the completion of certain milestones by PointR for the shareholders to earn additional shares. The Company evaluated the probability of the earning of the milestones and concluded that the probability of achievement of the milestones had not changed, primarily due to the shifting of focus by the Company to develop AI technologies for the COVID-19 pandemic as well as other AI technologies. As such, the Company did not record any change to the valuation during the nine months ended September 30, 2024 or 2023, respectively.

 

Net Income (Loss) Per Share

 

Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share includes the effect of Common Stock equivalents (notes convertible into Common Stock, stock options and warrants) when, under either the treasury or if-converted method, such inclusion in the computation would be dilutive. For the three and nine months ended September 30, 2024 and 2023, no equivalent shares of the Common Stock were excluded as the company has a loss and addition of such stock equivalents in the computation would have been anti-dilutive.

 

Stock-Based Compensation

 

The Company applies the provisions of ASC 718, Compensation—Stock Compensation (“ASC 718”), which requires the measurement and recognition of compensation expense for all stock-based awards made to employees, including employee stock options, in the statements of operations.

 

For stock options issued to employees and members of the Board of Directors (the “Board”) for their services, the Company estimates the grant date fair value of each option using the Black-Scholes option pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock. For awards subject to service-based vesting conditions, including those with a graded vesting schedule, the Company recognizes stock-based compensation expense equal to the grant date fair value of stock options on a straight-line basis over the requisite service period, which is generally the vesting term. Forfeitures are recorded as they are incurred as opposed to being estimated at the time of grant and revised.

 

 

For warrants issued in connection with fund raising activities, the Company estimates the grant date fair value of each warrant using the Black-Scholes pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the warrant, the expected volatility of the Common Stock consistent with the expected life of the warrant, risk-free interest rates and expected dividend yields of the Common Stock. If the warrants are issued upon termination or cancellation of prior issued warrants, then the Company estimates the grant date fair value of the new warrants using the Black-Scholes pricing model and evaluates whether the new warrants are deemed as equity instruments or liability instruments. If the warrants are deemed to be equity instruments, the Company records stock compensation expense and an addition to additional paid in capital. If, however, the warrants are deemed to be liability instruments, then the fair value is treated as a deemed dividend and credited to additional paid in capital.

 

Impairment of Long-Lived Assets

 

The Company reviews long-lived assets, including definite-lived intangible assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of these assets is determined by comparing the forecasted undiscounted net cash flows of the operation to which the assets relate to the carrying amount. If the operation is determined to be unable to recover the carrying amount of its assets, then these assets are written down first, followed by other long-lived assets of the operation to fair value. Fair value is determined based on discounted cash flows or appraised values, depending on the nature of the assets. For the three and nine months ended September 30, 2024 and 2023, respectively, there were no impairment losses recognized for long-lived assets.

 

Intangible Assets

 

The Company records its intangible assets at cost in accordance with ASC 350, Intangibles – Goodwill and Other. The Company reviews the intangible assets for impairment on an annual basis or if events or changes in circumstances indicate it is more likely than not that they are impaired. These events could include a significant change in the business climate, legal factors, a decline in operating performance, competition, sale or disposition of a significant portion of the business, or other factors. If the review indicates the impairment, an impairment loss would be recorded for the difference of the value recorded and the new value. For the nine months ended September 30, 2024 and September 30, 2023, there were no impairment losses recognized for intangible assets. When we sell or contribute properties to unconsolidated arrangements and retain a non-controlling ownership interest in such assets, we recognize the difference between the consideration received and the carrying amount of the asset sold or contributed.

 

Goodwill

 

Goodwill represents the excess of the purchase price of acquired business over the estimated fair value of the identifiable net assets acquired. Goodwill is not amortized but is tested for impairment at least once annually, at the reporting unit level or more frequently if events or changes in circumstances indicate that the asset might be impaired. The goodwill impairment test is applied by performing a qualitative assessment before calculating the fair value of the reporting unit. If, on the basis of qualitative factors, it is considered not more likely than not that the fair value of the reporting unit is less than the carrying amount, further testing of goodwill for impairment would not be required. Otherwise, goodwill impairment is tested using a two-step approach.

 

The first step involves comparing the fair value of the reporting unit to its carrying amount. If the fair value of the reporting unit is determined to be greater than its carrying amount, there is no impairment. If the reporting unit’s carrying amount is determined to be greater than the fair value, the second step must be completed to measure the amount of impairment, if any. The second step involves calculating the implied fair value of goodwill by deducting the fair value of all tangible and intangible assets, excluding goodwill, of the reporting unit from the fair value of the reporting unit as determined in step one. The implied fair value of the goodwill in this step is compared to the carrying value of goodwill. If the implied fair value of the goodwill is less than the carrying value of the goodwill, an impairment loss equivalent to the difference is recorded. For the three and nine months ended September 30, 2024, we recorded an impairment loss of approximately $3 million on our goodwill. For the three and nine months ended September 30, 2023, we recorded an impairment loss of approximately $0 and $6.1 million, respectively, based on the difference between the carrying value of our goodwill as against the market capitalization of the Company. For more information on goodwill and impairment, refer to Note 3 to these Notes to the Consolidated Financial Statements.

 

 

Derivative Financial Instruments Indexed to the Company’s Common Stock

 

We have generally issued derivative financial instruments, such as warrants, in connection with our equity offerings. We evaluate the terms of these derivative financial instruments in order to determine their accounting treatment in our financial statements. Key considerations include whether the financial instruments are freestanding and whether they contain conditional obligations. If the warrants are freestanding, do not contain conditional obligations and meet other classification criteria, we account for the warrants as an equity instrument. However, if the warrants contain conditional obligations, then we account for the warrants as a liability until the conditional obligations are met or are no longer relevant. Because no established market prices exist for the warrants that we issue in connection with our equity offerings, we must estimate the fair value of the warrants based on the price of our Common Stock as of December 31 each year, which is as inherently subjective as it is for stock options, and for similar reasons as noted in the stock-based compensation section above. For financial instruments which are accounted for as a liability, we report any changes in their estimated fair values as gains or losses in our Consolidated Statement of Income.

 

Convertible Instruments

 

The Company evaluates and accounts for conversion options embedded in its convertible instruments in accordance with ASC 815 “Derivatives and Hedging”.

 

ASC 815 generally provides three criteria that, if met, require companies to bifurcate conversion options from their host instruments and account for them as free-standing derivative financial instruments. These three criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur, and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. Professional standards also provide an exception to this rule when the host instrument is deemed to be conventional as defined under professional standards as “The Meaning of Conventional Convertible Debt Instrument.”

 

The Company accounts for convertible instruments (when it has determined that the embedded conversion options should not be bifurcated from their host instruments) in accordance with ASC 470-20 “Debt – Debt with Conversion and Other Options.” Accordingly, the Company records, when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments based upon the differences between the fair value of the underlying Common Stock at the commitment date of the note transaction and the effective conversion price embedded in the note. Original issue discounts (“OID”) under these arrangements are amortized over the term of the related debt to their earliest date of redemption. The Company also records when necessary deemed dividends for the intrinsic value of conversion options embedded in preferred shares based upon the differences between the fair value of the underlying Common Stock at the commitment date of the note transaction and the effective conversion price embedded in the note.

 

ASC 815-40 “Derivatives and Hedging – Contracts in Entity’s Own Equity” provides that, among other things, generally, if an event is not within the entity’s control could or require net cash settlement, then the contract shall be classified as an asset or a liability.

 

 

Variable Interest Entity (VIE) Accounting

 

The Company evaluates its ownership, contractual relationships and other interests in entities to determine the nature and extent of the interests, whether such interests are variable interests and whether the entities are VIEs in accordance with ASC 810, Consolidations. These evaluations can be complex and involve Management judgment as well as the use of estimates and assumptions based on available historical information, among other factors. Based on these evaluations, if the Company determines that it is the primary beneficiary of a VIE, the entity is consolidated into the financial statements. At September 30, 2024 and September 30, 2023, the Company identified EdgePoint to be the Company’s sole VIE. At September 30, 2024 and September 30, 2023, the Company’s ownership percentage of EdgePoint was 29% and 29%, respectively. The VIE’s net assets were less than $0.1 million at September 30, 2024 and December 31, 2023, respectively.

 

Investments - Equity Method

 

The Company accounts for equity method investments at cost, adjusted for the Company’s share of the investee’s earnings or losses, which are reflected in the consolidated statements of operations. The Company periodically reviews the investments for other than temporary declines in fair value below cost and more frequently when events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. The Investment in GMP Bio represents the investment into equity securities for which the Company elected the fair value option pursuant to ASC 825-10-15 and subsequent fair value changes in the GMP Bio shares shall be included in the result from other income. Refer to Note 6 to these Notes to the Consolidated Financial Statements.

 

Joint Venture agreement

 

We have equity interest in unconsolidated arrangement that is primarily engaged in the business of drug discovery, development, and commercialization, including but not limited to development and commercialization of TGF-beta therapeutics as well as establishing and operating contract development and manufacturing organization (“CDMO”) facilities and capabilities. The Company first reviews the arrangement to determine if it meets the definition of an accounting joint venture pursuant to ASC 323-10-20. In order to meet the definition of a joint venture, the arrangement must have all of the following characteristics, (i) the arrangement is organized within a separate legal entity, (ii) the entity is under the joint control of the venturers, (iii) the venturers must be able to exercise joint control through their equity investments, (iv) the qualitative characteristics of the entity, including its purpose and design must be consistent with the definition of a joint venture.

 

We consolidate arrangements that are considered to be VIEs where we are the primary beneficiary. We analyze our investments in joint ventures to determine if the joint venture is considered a VIE and would require consolidation. We (i) evaluate the sufficiency of the total equity investment at risk, (ii) review the voting rights and decision-making authority of the equity investment holders as a group and whether there are limited partners (or similar owning entities) that lack substantive participating or kick out rights, guaranteed returns, protection against losses, or capping of residual returns within the group and (iii) establish whether activities within the venture are on behalf of an investor with disproportionately few voting rights in making this VIE determination.

 

To the extent that we own interests in a VIE and we (i) have the power to direct the activities that most significantly impact the economic performance of the VIE and (ii) have the obligation or rights to absorb losses or receive benefits that could potentially be significant to the VIE, then we would be determined to be the primary beneficiary and would consolidate the VIE. To the extent that we own interests in a VIE, then at each reporting period, we re-assess our conclusions as to which, if any, party within the VIE is considered the primary beneficiary.

 

To the extent that our arrangements do not qualify as VIEs, they are consolidated if we control them through majority ownership interests or if we are the managing entity (general partner or managing member) and our partner does not have substantive participating rights. Control is further demonstrated by our ability to unilaterally make significant operating decisions, refinance debt, and sell the assets of the joint venture without the consent of the non-managing entity and the inability of the non-managing entity to remove us from our role as the managing entity.

 

We use the equity method of accounting for those arrangements where we exercise significant influence but do not have control. Under the equity method of accounting, our investment in each arrangement is included on our consolidated balance sheet; however, the assets and liabilities of the joint ventures for which we use the equity method are not included on our consolidated balance sheet.

 

 

When we sell or contribute properties to unconsolidated arrangements and retain a non-controlling ownership interest in such assets, we recognize the difference between the consideration received and the carrying amount of the asset sold or contributed when its derecognition criteria are met. The equity method investment we retain in such partial sale transactions is noncash consideration and is measured at fair value. As a result, the accounting for a partial sale will result in the recognition of a full gain or loss.

 

When circumstances indicate there may have been a reduction in the value of an equity investment, we evaluate whether the loss in value is other than temporary. If we conclude it is other than temporary, we recognize an impairment charge to reflect the equity investment at fair value.

 

The Company elected the fair value option under the fair value option Subsection of Section 825-10-15 to account for its equity-method investment as the Company believes that the fair value option is most appropriate for a company in the biotechnology industry, The fair value option is more appropriate for companies that are involved in extensive and usually very expensive research and development efforts, which are not appropriately reflected in the market value or reflective of the true value of the development activities of the company.

 

Embedded debt costs in convertible debt instruments

 

In August 2020, the FASB issued “ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40)” (“ASU 2020-06”) which simplifies the accounting for convertible instruments. The guidance removes certain accounting models which separate the embedded conversion features from the host contract for convertible instruments. Either a modified retrospective method of transition or a fully retrospective method of transition was permissible for the adoption of this standard. Update No. 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption was permitted no earlier than the fiscal year beginning after December 15, 2020. The Company adopted ASU 2020-06 effective January 1, 2023 and has removed the effects of any embedded conversion features from certain of our convertible instruments as of that date.

 

Revenue Recognition

 

The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers (Topic 606).

 

Under Topic 606, the Company recognizes revenue when its customers obtain control of the promised good or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. The Company applies the following five-step: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation.

 

At contract inception, once the contract is determined to be within the scope of Topic 606, the Company identifies the performance obligation(s) in the contract by assessing whether the goods or services promised within each contract are distinct. The Company then recognizes revenue for the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

 

The Company anticipates generating revenues from rendering services to other third-party customers for the development of certain drug products and/or in connection with certain out-licensing agreements. In the case of services rendered for development of the drugs, revenue is recognized upon the achievement of the performance obligations or over time on a straight-line basis over the extended service period. In the case of out-licensing contracts, the Company records revenues either upon achievement of certain pre-defined milestones, when there is no obligation of the Company achieve any performance obligations in connection with the said pre-defined milestones, or upon achievement of the performance obligations if the milestones require the Company to provide the performance obligations.

 

The Company occasionally collects advance payments from customers toward commitments to provide services or performance obligations, in which case the advance payment is recorded as a liability until the obligations are fulfilled and revenue is recognized.

 

 

Research & Development Costs

 

In accordance with ASC 730-10-25 “Research and Development”, research and development costs are charged to expense as and when incurred.

 

Recent Accounting Pronouncements

 

In August 2020, the FASB issued “ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40)” (“ASU 2020-06”) which simplifies the accounting for convertible instruments. The guidance removes certain accounting models which separate the embedded conversion features from the host contract for convertible instruments. Either a modified retrospective method of transition or a fully retrospective method of transition was permissible for the adoption of this standard. Update No. 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption was permitted no earlier than the fiscal year beginning after December 15, 2020. The Company adopted ASU 2020-06 effective January 1, 2023 and recorded approximately $0.5 million as a reduction to the additional paid in capital and added approximately $0.3 million to the opening retained earnings in accordance with the authoritative guidance under ASU 2020-06.

 

All other newly issued but not yet effective accounting pronouncements have been deemed to be not applicable or immaterial to the Company.

 

v3.24.3
INTANGIBLE ASSETS AND GOODWILL
9 Months Ended
Sep. 30, 2024
Intangible Assets And Goodwill  
INTANGIBLE ASSETS AND GOODWILL

NOTE 3 - INTANGIBLE ASSETS AND GOODWILL

 

Goodwill from 2019 Reverse Merger with Oncotelic and PointR

 

The Company completed the reverse merger with Oncotelic Inc. (“Merger”) in April 2019. The Company completed the merger with PointR Data Inc (“PointR Merger”) in November 2019. For more details on the two mergers, refer to our 2020 Annual Report on Form 10-K for the year ended December 31, 2020 filed by the Company on April 15, 2021.

 

The Oncotelic merger gave rise to Goodwill of approximately $4.9 million. Upon the non-financial sale of our asset as contribution to our equity method investment, we derecognized the balance of the carrying value of our goodwill of approximately $4.9 million from the Oncotelic Merger in accordance with our policy and authoritative accounting guidance.

 

Further, we added goodwill of $16,182,456 upon the completion of the Merger with PointR.

 

We have one operating segment and reporting unit. Accordingly, our review of goodwill impairment indicators was performed at the entity-wide level. In performing our annual impairment assessment, we determined if we should qualitatively assess whether it was more likely than not the fair value of goodwill was less than its carrying amount (the qualitative impairment test). The factors we considered in the assessment included our market capitalization, general macroeconomic conditions, conditions specific to the industry and market and whether there had been sustained declines in our share price. If we concluded, it was more likely than not, the fair value of the reporting unit was less than its carrying amount, or elected not to use the qualitative impairment test, a quantitative impairment test would be performed.

 

We used our market capitalization as an indicator of fair value. While we believe the fair value measurement need not be based solely on the quoted market price of an individual share of our Common Stock, and that we also could consider the impact of a control premium in measuring the fair value of its reporting unit. In the absence of any other valuation metrics, the Company believed using a control premium utilized would not be appropriate under the current circumstances. We also considered some other market comparables’ trends in our stock price as well as the industry over a period of two successive quarters and prospective quarter to evaluate whether the fair value of our reporting unit was greater than our carrying amount. As such, we performed a quantitative impairment assessment of goodwill for our single reporting unit at the end of 2023, due to a sustained decline in our market capitalization and an increase in negative economic outlook for biotech markets We estimated and reconciled the fair value of our reporting unit utilizing our market capitalization based on the stock price of our Common Stock as of December 31, 2023. Before completing our goodwill impairment test, we first tested our indefinite-lived intangible asset then our remaining long-lived assets for impairment. We concluded our indefinite-lived intangible assets were not impaired. Based on the market capitalization, we further concluded the fair value of our single reporting unit was less than its carrying value and therefore recognized an impairment charge of $6.1 million during the year ended December 31, 2023. The calculation of the impairment charge included substantial fact-based determinations and estimates. The Company evaluated if it needed to record any additional goodwill impairment as of September 30, 2024, based solely on the market capitalization of the Company and concluded that an additional impairment of approximately $3.2 million was required to be recorded for the nine months ended September 30, 2024.

 

 

A summary of our goodwill as of September 30, 2024 and December 31, 2023 is shown below:

 

  

September 30,

2024

  

December 31,

2023

 
Balance at January 1, 2024 and 2023  $5,988,230   $12,071,376 
Less: Goodwill impairment due to market capitalization   (3,200,000)   (6,083,146)
           
Balance at September 30, 2024 and December 31, 2023  $2,788,230   $5,988,230 

 

In general, the goodwill is tested on an annual impairment date of December 31, unless we observe any further deterioration in our market capitalization in any interim periods, in which case we may, depending on the materiality of the impairment, record an impairment at the end of other reporting periods, as we did during the course of the year ended December 31, 2023.

 

In-Process Research & Development (“IPR&D”) Summary

 

The IPR&D assets were acquired in the PointR Merger during the year ended December 31, 2019. Since January 2021, the Company has determined that the IPR&D should be reported as an indefinitely lived asset and therefore will evaluate, on an annual basis, for any impairment on the IPR&D and will record an impairment if identified. The balance of IPR&D as of September 31, 2024 and December 31, 2023, respectively, was $1,101,760. For more information on the IPR&D, please refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

v3.24.3
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
9 Months Ended
Sep. 30, 2024
Payables and Accruals [Abstract]  
ACCOUNTS PAYABLE AND ACCRUED EXPENSES

NOTE 4 – ACCOUNTS PAYABLE AND ACCRUED EXPENSES

 

Accounts payable and accrued expense consists of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
         
Accounts payable  $1,692,263   $1,656,613 
Accrued expense   769,860    780,708 
Accounts payable and accrued liabilities  $2,462,123   $2,437,321 

 

  

September 30,

2024

  

December 31,

2023

 
           
Accounts payable – related party  $345,543   $344,099 

 

 

v3.24.3
CONVERTIBLE DEBENTURES, NOTES AND OTHER DEBT
9 Months Ended
Sep. 30, 2024
Debt Disclosure [Abstract]  
CONVERTIBLE DEBENTURES, NOTES AND OTHER DEBT

NOTE 5 – CONVERTIBLE DEBENTURES, NOTES AND OTHER DEBT

 

As of September 30, 2024 and December 31, 2023, special purchase agreements (SPAs) with convertible debentures and notes, net of debt discount and including accrued interest, if any, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
Current Debt          
Convertible debentures          
10% Convertible note payable – Bridge Investor  $35,556   $35,556 
10% Convertible note payable – Related Party   164,444    164,444 
10% Convertible note payable – Bridge Investor   200,000    200,000 
Convertible note payable   400,000    400,000 
Fall 2019 Notes          
5% Convertible note payable – Stephen Boesch   132,708    128,958 
5% Convertible note payable – Related Party   310,608    301,233 
5% Convertible note payable – Dr. Sanjay Jha (Through his family trust)   310,128    300,753 
5% Convertible note payable – CEO & CFO – Related Parties   101,634    98,559 
5% Convertible note payable – Bridge Investors   208,222    201,922 
Convertible note payable   1,063,300    1,031,425 
August 2021 Convertible Notes          
5% Convertible note – Autotelic Inc– Related Party   289,427    280,052 
5% Convertible note – Bridge investors   432,406    418,399 
5% Convertible note – CFO – Related Party   86,832    84,018 
 Convertible note payable    808,665    782,469 
JH Darbie PPM Debt          
16% Convertible Notes – Non-related parties   -    311,693 
16% Convertible Notes – CEO – Related Party   -    - 
Convertible note payable   -    311,693 
           
November/December 2021 & March 2022 Notes          
16% Convertible Notes – Accredited Investors   225,296    233,393 
           
Debt for Clinical Trials – Forever Prosperity ( Formerly GMP)          
2% Convertible Notes – Forever Prosperity   4,817,562    4,750,000 
           
May 2022 Note          
16% Convertible Notes – Accredited Investors   972,500    1,401,283 
           
Other Debt          
Short term debt – Bridge investors   210,000    210,000 
Short term debt from CFO – Related Party   50,050    35,050 
Short term debt – Autotelic Inc. – Related Party   2,070,000    1,470,000 
Short Term Debt from CEO – Related Party   50,000    50,000 
 Short term debt    2,380,050    1,765,050 
Total of short term convertible debentures & notes and other debt  $10,667,373    10,675,313 

 

  

September 30,

2024

  

December 31,

2023

 
Long Term Debt          
JH Darbie PPM 2 Debt          
16% Convertible Notes - Non-related parties   2,142,849    1,773,468 
16% Convertible Notes – CEO – Related Party   125,000    125,000 
 Convertible note payable    2,267,849    1,898,468 

 

 

Convertible Debentures

 

As of September 30, 2024, the Company had a derivative liability of approximately $282,000 and recorded a change in fair value of approximately $140,000 on the Convertible Debentures issued in 2019 to our CEO and a bridge investor.

 

Bridge Financing

 

Notes with Officer and Bridge Investor

 

In April 2019, the Company entered into a Securities Purchase Agreement (the “Bridge SPA”) with our CEO (the “Trieu Note”) and a Bridge Investor with a commitment to purchase convertible notes in the aggregate of $400,000. For more information on the Bridge SPA, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

The issuance of the Trieu Note resulted in a discount from the beneficial conversion feature totaling $131,555 related to the conversion feature. Total amortization of the OID and the discount totaled approximately $0 for the nine months ended September 30, 2024 and 2023, respectively. Total unamortized discount on this note was approximately $0 as of September 30, 2024, and December 31, 2023, respectively.

 

In April 2019, pursuant to the Bridge SPA the Company entered into Convertible Note Tranche #1 (“Tranche #1”) with the Bridge Investor. For more information on Tranche #1, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

The issuance of the note resulted in a discount from the beneficial conversion feature totaling $28,445. Total amortization of the OID and discount totaled approximately $0 for the nine months ended September 30, 2024, and 2023, respectively. Total unamortized discount on this note was approximately $0 as of September 30, 2024, and December 31, 2023.

 

In August 2019, pursuant to the Bridge SPA the Company entered into Convertible Note Tranche #2 (“Tranche #2”) with the Bridge Investor. For more information on Tranche #2, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

The issuance of the note resulted in a discount from the beneficial conversion feature totaling $175,000. Total amortization of the OID and discount totaled approximately $0 for the nine months ended September 30, 2024, and 2023, respectively. Total unamortized discount on this note was $0 as of September 30, 2024, and December 31, 2023.

 

Fall 2019 Debt Financing

 

Between November and December 2019, the Company closed its Fall 2019 Debt Financing and entered into certain Note Purchase Agreements (the “Fall 2019 Note Purchase Agreements”) with certain accredited investors and the officers of the Company for the sale of convertible promissory notes (the “Fall 2019 Notes”). The Company issued Fall 2019 Notes in the principal amount of $250,000 to each of Dr. Vuong Trieu, the Company’s Chief Executive Officer, and Stephen Boesch, in exchange for gross proceeds of $500,000. Further, the Company issued Fall 2019 Notes to additional investors including $250,000 to Dr. Sanjay Jha, through his family trust, the former CEO of Motorola and COO/President of Qualcomm. The Company also offset certain amounts due to Dr. Vuong Trieu, the Company’s Chief Executive Officer, Chulho Park, the Company’s then Chief Technology Officer, and Amit Shah, the Company’s Chief Financial Officer, all related parties as Officers of the Company, and converted such amounts due into the Fall 2019 Notes. $35,000 due to Dr. Vuong Trieu, $27,000 due to Chulho Park and $20,000 due to Amit Shah were converted into convertible debt under the Fall 2019 Notes. The Company also issued the Fall 2019 Notes of $168,000 to two accredited investors.

 

All the Fall 2019 Notes provided for interest at the rate of 5% per annum and are unsecured. For more information on the Fall 2019 Debt Financing, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

 

There was no activity during the nine months ended September 30, 2024 and 2023. The total unamortized principal amount of the Fall 2019 Notes was $850,000 as of September 30, 2024, and December 31, 2023.

 

Further, the Company recorded interest expense of $10,600 and $32,000 on these Fall 2019 Notes for the three and nine months ended September 30, 2024 and September 30, 2023, respectively. The total amount outstanding under the Fall 2019 Notes, net of discounts and including accrued interest thereon, as of September 30, 2024 and December 31, 2023, was $1,063,300 and $1,031,425, respectively.

 

GMP Notes

 

In June 2020, the Company secured $2 million in debt financing, evidenced by a one-year convertible note (the “GMP Note”) from GMP, to conduct a clinical trial evaluating OT-101 against COVID-19 bearing 2% annual interest, and is personally guaranteed by Dr. Vuong Trieu, the Chief Executive Officer of the Company. The GMP Note is convertible into the Company’s Common Stock upon the GMP Note’s maturity of the GMP Note, at the Company’s Common Stock price on the date of conversion with no discount. GMP has waived the default in the maturity of the GMP Note and as such there is no event of default and also agreed to extend the date of maturity of the GMP Note to December 31, 2024. GMP does not have the option to convert prior to the GMP Note’s maturity. Such financing will be utilized solely to fund the clinical trial. The Company’s liability under GMP Note commenced to accrue when GMP first began to pay for services related to the clinical trial to our third-party clinical research organization, up to a maximum of $2 million. GMP has been invoiced by the clinical research organization for the full $2 million as of September 30, 2024, and as such the Company has recognized the liability as a convertible debt.

 

In September 2021, the Company secured a further $1.5 million in debt financing, evidenced by a one-year convertible note (the “GMP Note 2”) from GMP, to fund the same clinical trial evaluating OT-101 against COVID-19 bearing 2% annual interest. The GMP Note is convertible into the Company’s Common Stock upon the GMP Note 2’s maturity one year from the date of the GMP Note 2, at the Company’s Common Stock price on the date of conversion with no discount. GMP has waived the default in the maturity of the GMP Note and as such there is no event of default and also agreed to extend the date of maturity of the GMP Note to December 31, 2024. GMP does not have the option to convert prior to the GMP Note 2’s maturity at the end of one year. Such financing was to be utilized solely to fund the clinical trial. As of September 30, 2024, GMP was invoiced by the clinical research organization for $1.5 million. Till date, GMP paid the clinical trial organization the $1.0 million.

 

In October 2021, the Company entered into an Unsecured Convertible Note Purchase Agreement (the “October Purchase Agreement”) with GMP, pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of $0.5 million (the “October 2021 Note”), which October 2021 Note is convertible into shares of the Company’s Common Stock. GMP has waived the default in the maturity of the GMP Note and as such there is no event of default and also agreed to extend the date of maturity of the GMP Note to December 31, 2024.

 

In January 2022, the Company entered into an Unsecured Convertible Note Purchase Agreement (the “January Purchase Agreement”) with GMP, pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of $0.5 million (the “January 2022 Note”), which January 2022 Note is convertible into shares of the Company’s Common Stock. GMP agreed to extend the date of maturity of the January 2022 Note to December 31, 2024.

 

Cumulatively, the GMP Note, GMP Note 2, October 2021 Note and the January 2022 Notes are referred to as the “GMP Notes”. The GMP Notes carry an interest rate of 2% per annum and mature on the earlier of (a) the one- year anniversary of the date of the Purchase Agreement, or (b) the acceleration of the maturity by GMP upon occurrence of an Event of Default (as defined below). All Notes contain a voluntary conversion mechanism whereby GMP may convert the outstanding principal and accrued interest under the terms of all the GMP Notes into shares of Common Stock (the “Conversion Shares”), at the consolidated closing bid price of the Company’s Common Stock on the applicable OTC Market as of the date the Company receives a Notice of Conversion from GMP. Prepayment of the GMP Notes may be made at any time by payment of the outstanding principal amount plus accrued and unpaid interest. The October Note contains customary events of default (each an “Event of Default”). If an Event of Default occurs, at GMP’s election, the outstanding principal amount of the GMP Notes, plus accrued but unpaid interest, will become immediately due and payable in cash. The October Purchase Agreement requires the Company to use of the proceeds received under the October 2021 Note to support the clinical development of OT-101, including payroll and has been made in continuation of the relationship between the Company and GMP. All the GMP notes were assigned to Forever Prosperity, LLC, an affiliated entity of GMP. The total principal outstanding on all the GMP notes, inclusive of accrued interest, was approximately $4.81 million and $4.75 million, both as of September 30, 2024 and December 31, 2023, respectively. During the three and nine months ended September 30, 2024, and 2023, the Company incurred approximately $22,700 and $67,500 of interest expense, respectively.

 

 

August 2021 Notes

 

In August 2021, the Company entered into Note Purchase Agreements with Autotelic - a related party, our CFO – a related party, and certain accredited investors (the “August 2021 investors”), whereby the Company issued four convertible notes in the aggregate principal amount of $698,500 convertible into shares of common stock of the Company for net proceeds of approximately $691,000. The convertible notes carry a five (5%) percent coupon and mature one year from issuance. The majority of the August 2021 investors have the right, but not the obligation, not more than five days following the maturity date, to convert all, but not less than all, the outstanding and unpaid principal plus accrued interest into the Company’s common stock, at a conversion price of $0.18. The August 2021 Note Holders has waived the default in the maturity of the August 2021 Notes and as such there is no event of default and also agreed to extend the date of maturity of the August 2021 Notes to December 31, 2024. The Company determined that the economic characteristics and risks of the embedded conversion option are not clearly and closely related to the economic characteristics and risks of the debt host instrument. Further, the Company determined that the embedded conversion feature meets the definition of a derivative but met the scope exception to the derivative accounting required under ASC 815 for certain contracts involving a reporting entity’s own equity.

 

As of September 30, 2024, and December 31, 2023, the August 2021 convertible notes, inclusive of accrued interest, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
Autotelic Related party convertible note, 5% coupon December 2023  $289,427   $280,052 
Accredited investors convertible note, 5% coupon December 2023   432,406    418,399 
CFO Related party convertible note, 5% coupon December 2023   86,832    84,018 
Convertible notes  $808,665   $782,469 

 

During the three and nine months ended September 30, 2024, the Company recognized approximately $8,730 and $26,200 of interest expense on the August 2021 Investors notes of which approximately $4,060 and $12,190 are attributable to related parties.

 

At September 30, 2024 and December 31, 2023, accrued interests on these convertible notes totaled approximately $110,000 and $84,000, respectively.

 

November – December 2021 and March 2022 Financing

 

In November / December 2021, the Company entered into securities purchase agreement with five institutional investors, whereby the Company issued five convertible notes in the aggregate principal amount of $1,250,000 convertible into shares of common stock of the Company. The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from issuance or upon event of default. Investors has the right at any time following issuance date to convert all or any part of the outstanding and unpaid amount of the note into the Company’s common stock at a conversion price established at a fixed rate of $0.07. The Company granted a total number of 9,615,385 warrants convertible into an equivalent number of the Company Common Stock at a strike price of $0.13 up to five years after issuance. The Placement agent was also granted a total of 961,540 warrants convertible into an equivalent number of the Company Common Stock at a strike price of $0.13 up to five years after issuance, as part of a finder’s fee agreement.

 

 

Further, in March 2022, the Company entered into a Securities Purchase Agreement with Fourth Man, pursuant to which the Company issued convertible promissory note in the aggregate principal amount of $0.25 million, convertible into shares of common stock of the Company. The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from issuance or upon event of default. As of December 31, 2022, this note is in Investors have the right at any time following issuance date to convert all or any part of the outstanding and unpaid amount of the note into the Company’s Common Stock at a conversion price established at a fixed rate of $0.10. The Company granted a total number of 1,250,000 warrants convertible into an equivalent number of the Company common shares at a strike price of $0.20 up to five years after issuance. The Placement agent was also granted a total of 125,000 warrants convertible into an equivalent number of the Company Common Stock at a strike price of $0.20 up to five years after issuance, as part of a finder’s fee agreement.

 

As of September 30, 2024, all of the November- December 2021 notes and any accrued interest, are fully converted.

 

As of September 30, 2024, and December 31, 2023, the March 2022 Fourth Man convertible note, including accrued interest and net of debt discount, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
         
Fourth Man Convertible note, 16% coupon March 2023 inclusive of accrued interest and default provision  $225,296   $233,393 
Unamortized debt discount   -    - 
Convertible notes, net  $225,296    233,393 

 

In February 2024, the Company converted approximately $35,000 in principal, accrued interest and legal fees into 500,000 shares of common stock. The note includes a default amount calculated at 125% of the unpaid principal and accrued interest. The Company recognized approximately $8,400 and $25,500 of interest during the three and nine months ended September 30, 2024. Similarly, the Company recognized approximately $8,400 and $23,000 of interest during the three and nine months ended September 30, 2023. As of September 30, 2024, the Fourth Man note was in technical default as the Company failed to repay the principal at the maturity date. However, the Company has not received notification of default from the lender. The default provision requires the accrual of a default penalty of 25% of the outstanding principal plus accrued interest. The Company has recorded an estimated default penalty of approximately $70,000. As of September 30, 2024 and December 31, 2023, the balance of the unamortized debt discount was $0. The Company adopted ASU 2020-06 on January 1, 2023, which resulted in the reversal of the original BCF amount to additional paid in capital for $109,349, reversal of the unamortized debt discount related to the BCF for $25,489 with the balance being recorded through retained earnings for $78,460.

 

May 2022 Mast Financing

 

In May 2022, the Company entered into a securities purchase agreement with one institutional investor, whereby the Company issued one convertible note in the aggregate principal amount of $605,000 convertible into shares of common stock of the Company (“May 2022 Mast Note”). The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from issuance or upon event of default. Investor has the right at any time following issuance date to convert all or any part of the outstanding and unpaid amount of the note into the Company’s common stock at a conversion price established at a fixed rate of $0.10. The Company granted a total number of 3,025,000 warrants convertible into an equivalent number of the Company common shares at a strike price of $0.20 up to five years after issuance. The Placement agent was also granted a total amount of 302,500 as part of a finder’s fee agreement. Portion of the proceeds were be used to retire some of the November/December 2021 notes.

 

 

As of September 30, 2024, and December 31, 2023, the May 2022 Mast Financing, net of debt discount, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
Mast Hill Convertible note, 12% coupon May 2023, inclusive of accrued interest and penalty  $972,500   $905,484 
Convertible notes, net  $972,500   $905,484 

 

Accrued interest was approximately $198,000 and $131,000 as of September 30, 2024 and December 31, 2023. The May 2022 Mast Note was extended through May 27, 2025 at a cost of approximately $82,000, and which is included in the amount outstanding and payable to Mast as of September 30, 2024. Accrued interest was approximately $89,000 as of September 30, 2023.

 

The Company recognized approximately $0 of interest expense attributable to the amortization of the debt discount from the original debt discount, deferred financing costs, fair value allocated to the warrants during the three and nine months ended September 30, 2024 compared to $0 and approximately $146,000 during the three and nine months ended September 30, 2023, respectively.

 

Effective January 1, 2023, the Company adopted ASU 2020-06, which resulted in the reversal of the original BCF amount to additional paid in capital for approximately $0.2 million, a reversal of the unamortized debt discount related to the BCF for approximately $0.1 million, with the balance of approximately $0.1 million being recorded through retained earnings.

 

June 2022 Blue Lake Financing

 

In June 2022, the Company entered into a securities purchase agreement with one institutional investor, whereby the Company issued one convertible note in the aggregate principal amount of $335,000 convertible into shares of common stock of the Company (“June 2022 Blue Lake Note”). The convertible notes carry a twelve (12%) percent coupon and a default coupon of 16% and mature at the earliest of one year from issuance or upon event of default. Investor has the right at any time following issuance date to convert all or any part of the outstanding and unpaid amount of the note into the Company’s common stock at a conversion price established at a fixed rate of $0.10. The Company granted a total number of 837,500 warrants convertible into an equivalent number of the Company common shares at a strike price of $0.20 up to five years after issuance. The Placement agent was also granted a total amount of 83,750 warrants as part of a finder’s fee agreement. Portion of the proceeds will be used to retire some of the November/December 2021 notes.

 

In May 2024, Blue Lake converted the balance of their note of approximately $531,000 including principal, accrued interest and default penalty, into 7,605,760 common shares of the Company.

 

As of September 30, 2024, and December 31, 2023, convertible note under the June 2022 Blue Lake Financing, net of debt discount, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
Blue Lake Convertible note, 16% coupon June 2023, inclusive of accrued interest and penalty  $-   $495,800 
Convertible notes, net  $-   $495,800 

 

The Company recognized approximately $8,500 and $35,000 of interest expense attributable to the amortization of the debt discount from the original debt discount, deferred financing costs, fair value allocated to the warrants during the three and nine months ended September 30, 2024, respectively. The Company recognized approximately $0 and approximately $62,000 of interest expense attributable to the amortization of the debt discount from the original debt discount, deferred financing costs, fair value allocated to the warrants and BCF during the three and nine months ended September 30, 2023.

 

 

The Company adopted ASU 2020-06 effective January 1, 2023, which resulted in the reversal of the original BCF amount to additional paid in capital of approximately $0.2 million, reversal of the unamortized debt discount of approximately $0.1 million related to the BCF and the balance of $0.1 million being recorded through retained earnings.

 

Other short-term advances

 

As of September 30, 2024 compared to December 31, 2023, other short-term advances consist of the following amounts obtained from various employees and related parties:

 

Other Advances 

September 30,

2024

  

December 31,

2023

 
Short term advance from CFO – Related Party  $50,050   $35,050 
Short term advance from CEO – Related Party   50,000    50,000 
Short term advances – bridge investors & others   210,000    210,000 
Short term advances – Autotelic Inc. – Related Party   2,070,000    1,470,000 
Short term advance  $2,380,050   $1,765,050 

 

During the year ended December 31, 2023, Autotelic provided $1.4 million in various short-term loans to the Company. During the nine months ended September 30, 2024 Autotelic Inc. provided additional short-term funding of $600,000 to the Company. As such, approximately $2.01 million was outstanding and payable to Autotelic at September 30, 2024.

 

The Company’s CFO was owed approximately $25 thousand at December 31, 2022. During the year ended December 31, 2023, the company’s CFO provided additional short-term advance of $10 thousand. During the nine months ended September 30, 2024, the CFO provided additional short-term funding of $15 thousand. As such, approximately $50 thousand was outstanding from the Company’s CFO at September 30, 2024.

 

In December 2023, the Company received $50 thousand from the company’s CEO. As such, $50 thousand was outstanding to the Company’s CEO at September 30, 2024.

 

As of September 30, 2024 and December 31, 2023, respectively, approximately $210,000 was outstanding as short-term advances from certain bridge investors.

 

v3.24.3
JOINT VENTURE WITH GMP BIO AND AFFILIATES, EQUITY METHOD INVESTMENT
9 Months Ended
Sep. 30, 2024
Equity Method Investments and Joint Ventures [Abstract]  
JOINT VENTURE WITH GMP BIO AND AFFILIATES, EQUITY METHOD INVESTMENT

NOTE 6 - JOINT VENTURE WITH GMP BIO AND AFFILIATES, EQUITY METHOD INVESTMENT

 

On March 31, 2022, the Company entered into (i) a joint venture (the “JV”) agreement with Dragon and GMP Bio, both affiliates of GMP, (and the Company, Dragon and GMP Bio are collectively called the “Parties”) (the “JVA”), (ii) a license agreement for rights to OT-101 (the “US License Agreement”) for the territory within the United States of America (the “US”) with Sapu Holdings, LLC, a subsidiary of GMP Bio and (iii) a license agreement for rights to OT-101 for the rest of the world with GMP Bio (the “Ex-US Rights Agreement”, and the US License Agreement and the Ex-US License Agreement are collectively called the “Agreements”). Further, GMP Bio has been developing a new nanomedicine portfolio. The development of this platform is expected to move through filings with the US FDA, and other regulatory bodies outside of the United States, moving into clinical programs with the ultimate goal of commercializing the products, assuming a successful outcome for the products. For more information on the JV, JVA, and Agreements, refer to our 2022 Annual Report on Form 10-K/A filed with the SEC on April 19, 2023.

 

As of the effective date of the formation of the JV, the combined enterprise value of GMP Bio was approximately $50.4 million, comprising of the fair value of the Company’s investment in GMP Bio of approximately $22.7 million and the total original capital contributions by Dragon Overseas of approximately $27.7 million. As of September 30, 2024, the JV had approximately $32.8 million in assets, not including GMP Bio’s capital subscriptions of approximately $8.8 million; recorded approximately $1.0 million in liabilities and incurred approximately $4.8 million and approximately $4.5 million in operational expenses for the nine months ended September 30, 2024 and 2023, respectively. While GMP’s fiscal year commences on April 1 and ends on March 31, the Company has reported the operational expenses for the same fiscal period as the Company. The Company elected the fair value option under subsection of Section 825-10-15 to account for its equity-method investment as the Company believes that it the most appropriate method to properly value the Company and record a change in value when and upon conducting a fair value assessment. GMP Bio conducted a fair value valuation study of the entity. Based on the results of the valuation study and the 45% ownership of the Company in GMP Bio, the Company reported a change in fair value of the Company. As such, the Company reported a change in fair value of the investment in GMP Bio of approximately $13 thousand at December 31, 2023. No change has been assessed to the fair value of the company during the nine months ended September 30, 2024.

 

 

A summary of the change in fair value of our investment in GMP Bio, as of September 30, 2024 and December 31, 2023 is shown below:

 

  

September 30,

2024

  

December 31,

2023

 
Balance at January 1, 2024 and 2023  $22,653,225   $22,640,521 
Add: change in fair value of investment in GMP Bio   -    12,704 
           
Balance at December 31, 2024 and 2023  $22,653,225   $22,653,225 

 

For information on the various notes from GMP, refer to Note 5 – GMP Notes of the Notes to the Consolidated Financial Statements above.

 

v3.24.3
PRIVATE PLACEMENT AND JH DARBIE FINANCING
9 Months Ended
Sep. 30, 2024
Private Placement And Jh Darbie Financing  
PRIVATE PLACEMENT AND JH DARBIE FINANCING

NOTE 7 - PRIVATE PLACEMENT AND JH DARBIE FINANCING

 

During the period from July 2020 to March 31, 2021, the Company entered into various subscription agreements with certain accredited investors, including the CEO, pursuant to the JH Darbie Financing, whereby the Company issued and sold a total of 100 Units, for total gross proceeds of approximately $5 million, pursuant to the JH Darbie Placement Agreement, with each Unit consisting of:

 

  25,000 shares of Edge Point Common stock for a price of $1.00 per share of Edge Point Common stock.
     
  One convertible promissory note, convertible up to 25,000 shares of Edge Point Common stock, at a conversion price of $1.00 per share or up to 138,889 shares of the Company’s common stock, at a conversion price of $0.18 per share.
     
  50,000 warrants to purchase an equivalent number of shares of Edge Point Common stock at $1.00 per share and an equivalent number of shares of the Company’s common stock at $0.20 per share with a three-year expiration date.

 

During the period between July 2023 and January 2024, the Company converted the debt of forty six accredited investors from the JH Darbie Financing (now referred to as “PPM-1”) into the new subscription agreements under the new financing (“PPM-2”- See Note 8 below), which resulted in conversion of $2.35 million of old debt into new debt to the Company.

 

As September 30, 2024 and December 31, 2023 funds received under the JH Darbie Financing, net of debt discount, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
Convertible promissory notes          
Subscription agreements - accredited investors  $-   $311,693 
Subscription agreements – related party   -    - 
Total convertible promissory notes  $-   $311,693 

 

 

The Company incurred approximately $0.64 million of issuance costs, including legal costs of approximately $39,000, that are incremental costs directly related to the issuance of the various instruments bundled in the offering.

 

Concurrently with the sale of the Units, JH Darbie was granted a warrant, exercisable over a five-year period, to purchase 10% of the number of Units sold in the JH Darbie Financing. As such, the Company granted 10 Units to JH Darbie pursuant to the JH Darbie Placement Agreement.

 

The terms of convertible notes are summarized as follows:

 

  Term: Through March 31, 2022, extended further to March 31, 2023
  Coupon: 16%.
  Convertible at the option of the holder at any time in the Company’s Common Stock or Edgepoint Common Stock.
  The conversion price is initially set at $0.18 per share for the Company’s Common Stock or $1.00 for Edgepoint Common Stock, subject to adjustment.

 

In February 2022, the Company and all except one of the Investors agreed to extend the maturity date of the Notes from March 31, 2022, to March 31, 2023. In consideration for the extension of the Notes, the Company issued to the Investors an aggregate of 33,000,066 Oncotelic Warrants at a price of $0.15 per share of Company’s Common Stock. Each Investor were entitled to receive 333,334 Oncotelic Warrants for each Unit purchased. Upon the amendment of the terms of the convertible notes under the private placement memorandum. As incentive to extend the maturity date, approximately 33 million warrants were issued to the Unit Holders who participated in the amendment. The approximately 33 million warrants to purchase shares of our Common Stock expired on March 31, 2024. The Company repaid the 1-unit holder who did not participate in the amendment shortly after March 31, 2022. Further, during the year ended December 31, 2023, the Company repaid two of the unit holders, who held 5 units and opted not to participate in the new JH Darbie financing. While the Company had been in default under the PPM-1 since April 2023, as of the date of this Quarterly Report, with the conversion of the rest of the Note Holders under the PPM-1, the event of default has been addressed.

 

The Company recognized amortization expense related to the debt discount and debt issuance costs of approximately $0 and $8,400 for the nine months ended September 30, 2024 and, 2023 respectively, which is included in interest expense in the statements of operations.

 

v3.24.3
PRIVATE PLACEMENT -2 (PPM-2) AND JH DARBIE FUNDING
9 Months Ended
Sep. 30, 2024
Private Placement -2 Ppm-2 And Jh Darbie Funding  
PRIVATE PLACEMENT -2 (PPM-2) AND JH DARBIE FUNDING

NOTE 8 – PRIVATE PLACEMENT -2 (PPM-2) AND JH DARBIE FUNDING

 

During the period between July 2023 to January 2024, the Company entered into a series of subscription agreements with forty six accredited investors (the “Financing”) whereby the Company issued and converted a total of 94 Units from the previous PPM (“PPM -1”- See Note 7 above) into the current subscription agreements under the PPM-2, which resulted in conversion of $2.35 million of old debt into new debt to the Company; and the Company did not receive any cash proceeds through the July 2023 through January 2024 conversions., with each Unit consisting of:

 

  One 16% convertible unsecured promissory note (the “Note”) of $25,000, convertible into up to 250,000 shares of the Company’s common stock (par value of $0.01) based on a conversion price of $0.10 per share.
     
  250,000 warrants to purchase an equivalent number of shares of the Company’s common stock at a strike price of $0.12 per share (“Oncotelic warrant”).

 

JH Darbie and the Company are parties to a March 2023 placement agent agreement (“Agreement”) pursuant to which DH Darbie had the right to sell a minimum of 10 Units and a maximum of 200 Units on a best-efforts basis. For the 4 tranches of conversion related to PPM 2, placement agent fees of $377,500 were paid to JH Darbie. Based on the placement agent agreement, JH Darbie was entitled to a non-refundable $25,000 fee to start the due diligence process and 2% due diligence fees and 13% commissions on all subsequent conversions or new funding. In addition, the Company provided warrant coverage equal to 13 % of all of the units sold to JH Darbie. As the Company converted an aggregate of 94 units, JH Darbie was entitled to earn a total of 3,055,000 warrants. A total of 5 unit holders under the PPM-1 opted not to participate in the PPM-2.

 

 

In connection with the consummation of Tranche 1, 2 and 3 and 4 of the July 2023 PPM, the Company entered into a Registration Rights Agreement granting certain registration rights with respect to the shares of the Company’s Common Stock issued in connection with the financing, as well as the shares of the Company’s Common Stock issuable upon exercise of the Warrants. The issuance of the Units is exempt from the registration requirements of the Securities Act of 1933, as amended (“Securities Act”), in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as provided in Rule 506 of Regulation D promulgated thereunder. The shares of common stock and warrants and any shares of common stock issuable upon exercise of the warrants, have not been registered under the Securities Act or any other applicable securities laws, and unless so registered, may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act.

 

As of September 30, 2024 and December 31, 2023, the PPM2 - JH Darbie Financing, net of debt discounts, consisted of the following amounts:

 

  

September 30,

2024

   December 31,
2023
 
Convertible promissory notes          
PPM-2 Darbie Financing, inclusive of accrued interest, including related parties  $2,267,849   $1,898,468 
Total PPM-2 Darbie Financing, net of discounts  $2,267,849   $1,898,468 

 

The Company incurred approximately $0.4 million of issuance costs under the PPM-2 and are incremental costs directly related to the issuance of the various instruments bundled in the offering. Concurrently with the sale of the Units, JH Darbie was granted a total of 3,055,000 stock warrants, exercisable over a two-year period.

 

The terms of convertible notes are summarized as follows:

 

  Term: through January 31, 2026
  Coupon: 16%
  Convertible at the option of the holder at any time into the Company’s common stock
  Conversion price is set at $0.10 per share subject to standard anti-dilution provision.

 

Management reviewed the guidance per ASC 470-60 Troubled debt restructurings and ASC 470-50 Debt-Modifications and Extinguishments and concluded that the terms of the agreements were substantially different and, accounted for the transaction as a debt extinguishment. The transaction related to T4 resulted in a loss from debt extinguishment of approximately $88,000, which is presented in other expense in the consolidated statements of operations for the year ended March 31, 2024. The estimated volume weighted grant date fair value of approximately $0.026 per share associated with the warrants to purchase up to 3,390,000 shares of common stock issued in this offering, or a total of approximately $88,000 was recorded to additional paid-in capital. All warrants sold in this offering have an exercise price of $0.12 per share of the Company stock, subject to adjustment, are exercisable immediately and expire two years from the date of issuance. The fair value of the warrants was estimated using a Black Scholes valuation models using the following input values:

  

Expected Term   2 years 
Expected volatility   173%
Risk-free interest rate   4.29%
Dividend   0.00%

 

The Company recorded approximately $318,000 as an initial debt discount related to the four tranches of PPM 2. The Company recognized amortization expense related to the debt discount and debt issuance costs of approximately $39,800 and $117,000 for the three and nine months ended September 30, 2024. Similarly, The Company recognized amortization expense related to the debt discount and debt issuance costs of approximately $18,600 for the three and nine months ended September 30, 2023.

 

During the nine months ended September 30, 2024, and 2023, the Company incurred approximately $270,000 and $37,000 of interest expense related to the convertible notes, respectively.

 

 

v3.24.3
RELATED PARTY TRANSACTIONS
9 Months Ended
Sep. 30, 2024
Related Party Transactions [Abstract]  
RELATED PARTY TRANSACTIONS

NOTE 9 - RELATED PARTY TRANSACTIONS

 

Master Service Agreement with Autotelic Inc.

 

In October 2015, Oncotelic entered into a Master Service Agreement (the “MSA”) with Autotelic Inc., a related party that is partly-owned by the Company’s CEO Vuong Trieu, Ph.D. Dr. Trieu, a related party, is a control person in Autotelic Inc. Autotelic Inc. currently owns less than 10% of the Company. The MSA stated that Autotelic Inc. would provide business functions and services to the Company and allowed Autotelic Inc. to charge the Company for these expenses paid on its behalf. The MSA includes personnel costs allocated based on amount of time incurred and other services such as consultant fees, clinical studies, conferences and other operating expenses incurred on behalf of the Company. The Company had minimally used the services under the MSA since the formation of the JV with Dragon. The MSA requires a 90-day written termination notice in the event either party requires to terminate such services.

 

Expenses related to the MSA were approximately $500 and $1,500 and for the three and nine months ended September 30, 2024 as compared to approximately $500 and $11,000 for the same period of 2023.

 

License Agreement with Autotelic Inc.

 

In September 2021, the Company entered into an exclusive License Agreement with Autotelic. For more information on the exclusive license Agreement with Autotelic, refer to our 2023 Annual Report on Form 10-K filed with SEC on April 15, 2024.

 

Note Payable and Short-Term Loan – Related Parties

 

In April 2019, the Company issued a convertible note to Dr. Trieu totaling $164,444, including OID of $16,444, receiving net proceeds of $148,000, which was used by the Company for working capital and general corporate purposes. The Company issued a Fall 2019 Note to Dr. Trieu in the principal amount of $250,000. Dr. Trieu also offset certain amounts due to him in the amount of $35,000 and was converted into the Fall 2019 debt. During the year ended December 31, 2020, Dr. Trieu purchased a total of 5 Units under the private placement for a gross total of $250,000. During the year ended December 31, 2023, Dr Trieu provided short term loan of $50 thousand to the Company.

 

In May 2021, Autotelic provided an additional short-term funding of $250,000 to the Company, which was converted into the August 2021 Notes. Autotelic provided an additional $120,000 short-term loan to the Company during the year ended December 31, 2022. During the year ended December 31, 2023, Autotelic provided $1.4 million in short term advances to the Company. In addition, Autotelic provided a short term advance of $600,000 during the nine months ended September 30, 2024 and as such, approximately $2.01 million was outstanding and payable to Autotelic at September 30, 2024.

 

Artius Consulting Agreement

 

On March 9, 2020, the Company and Artius Bioconsulting, LLC (“Artius”), for which Mr. King is the Managing Member, entered into an amendment to the Consulting Agreement dated December 1, 2018, under which Artius agreed to serve as a consultant to the Company for services related to the Company’s business from time to time, effective December 1, 2019 (the “Effective Date”) (the “Artius Agreement”). For more information on this Agreement, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

No expense was recorded during the nine months ended September 30, 2024 and 2023, respectively, related to this Agreement.

 

 

Maida Consulting Agreement

 

Effective May 5, 2020, the Company and Dr. Maida entered into an independent consulting agreement, commencing April 1, 2020 (the “Maida Agreement”), under which Dr. Maida will assist the Company in providing medical expertise and advice from time to time in the design, conduct and oversight of the Company’s existing and future clinical trials. For more information on this Agreement, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 15, 2024.

 

The Company recorded an expense of $0 during the nine months ended September 30, 2024 and 2023 related to this Agreement. Effective April 1, 2022, Dr Maida’s compensation shall be borne by the JVA with GMP Bio.

 

v3.24.3
EQUITY PURCHASE AGREEMENT AND REGISTRATION RIGHTS AGREEMENT
9 Months Ended
Sep. 30, 2024
Equity Purchase Agreement And Registration Rights Agreement  
EQUITY PURCHASE AGREEMENT AND REGISTRATION RIGHTS AGREEMENT

NOTE 10 - EQUITY PURCHASE AGREEMENT AND REGISTRATION RIGHTS AGREEMENT

 

On May 3, 2021, the Company entered into an Equity Purchase Agreement (“EPL”) and Registration Rights Agreement with Peak One Opportunity Fund LP (“Peak One” or the “Investor”). For further information on EPL, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024. The Company also filed a post-effective amendment Registration Statement on Form S-1 with the Commission on April 12, 2024, and the Form S-1 was declared effective on April 22, 2024. The Company filed the prospectus under rule 424b3 with the SEC on April 26, 2024.

 

During the nine months ended September 30, 2024 and 2023, the Company did not sell any shares of Common Stock under the EPL.

 

v3.24.3
STOCKHOLDERS’ EQUITY
9 Months Ended
Sep. 30, 2024
Equity [Abstract]  
STOCKHOLDERS’ EQUITY

NOTE 11 - STOCKHOLDERS’ EQUITY

 

The following transactions affected the Company’s Stockholders’ Equity:

 

Issuance of Common Stock during the nine months ended September 30, 2024

 

In February 2024, Fourth Man partially converted $35,000 of their debt. In connection with the partial Note conversion, the Company issued 500,000 shares of Common Stock to Fourth Man.

 

In May 2024, Blue Lake converted the balance of their $531,000 debt, inclusive of accrued interest and penalty, into 7,605,760 shares of Common Stock of the Company.

 

Issuance of Common Stock during the nine months ended September 30, 2023

 

In February 2023, Blue Lake partially converted $71,750 of their debt. In connection with the partial Note conversion, the Company issued 1,025,000 shares of Common Stock to Blue Lake.

 

In June 2023, Blue Lake converted the full remainder of their $181,750 debt, accrued interest and penalty. In connection with this Note conversion, the Company issued 3,466,853 shares of Common Stock to Blue Lake.

 

In May and June 2023, Fourth Man converted $50,000 in principal and $30,000 in accrued interest into 1,192,857 shares of common stock.

 

In July 2023, Fourth Man converted approximately $43,000 balance in principal and accrued interest into 627,538 shares of Common Stock.

 

 

v3.24.3
STOCK-BASED COMPENSATION
9 Months Ended
Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]  
STOCK-BASED COMPENSATION

NOTE 12– STOCK-BASED COMPENSATION

 

Options

 

Pursuant to the Merger, the Company’s Common Stock and corresponding outstanding options survived. The below information details the Company’s associated option activity.

 

As of September 30, 2024, the Company had options to purchase Common Stock that were outstanding under three stock option plans – the 2017 Equity Incentive Plan (the “2017 Plan”), the 2015 Equity Incentive Plan (the “2015 Plan”) and the 2005 Stock Plan (the “2005 Plan”). Under the 2017 Plan, up to 2,000,000 shares of the Company’s Common Stock may be issued pursuant to awards granted in the form of nonqualified stock options, restricted and unrestricted stock awards, and other stock-based awards. Under the 2015 and 2005 Plans, taken together, up to 27,250,000 shares of the Company’s Common Stock may be issued pursuant to awards granted in the form of incentive stock options, nonqualified stock options, restricted and unrestricted stock awards, and other stock-based awards

 

Employees, consultants, and directors are eligible for awards granted under the 2017 and 2015 Plans. Since the adoption of the 2015 Plan, no further awards may be granted under the 2005 Plan, although options previously granted remain outstanding in accordance with their terms.

 

Compensation based stock option activity for qualified and unqualified stock options are summarized as follows:

 

       Weighted 
       Average 
For the nine months ended September 30, 2024  Shares   Exercise Price 
Outstanding at January 1, 2024   24,177,761   $0.21 
Expired or cancelled   -    - 
Outstanding at September 30, 2024   24,177,761    0.21 
Options exercisable at September 30, 2024   13,985,261    0.10 

 

       Weighted 
       Average 
For the nine months ended September 30, 2023  Shares   Exercise Price 
Outstanding at January 1, 2023   25,690,261   $0.23 
Expired or cancelled   (1,512,500)   0.46 
           
Outstanding at September 30, 2023   24,177,761    0.21 

 

Information on compensation-based stock option activity for qualified and unqualified stock options for the year ended December 31, 2023 can be found in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on April 12, 2024.

 

The following table summarizes information about options to purchase shares of the Company’s Common Stock outstanding and exercisable at September 30, 2024:

  

Exercise prices  

Outstanding

Options

  

Weighted-

Average

Remaining Life

In Years

  

Weighted-

Average

Exercise

Price

  

Number

Exercisable

 
                  
$0.1 to $0.15     16,250,000    7.5   $0.12    6,057,500 
 0.16 to $0.21     5,502,761    6.8    0.16    5,502,761 
 0.22 to $0.37     1,550,000    3.3    0.28    1,550,000 
 0.38 to $0.72     500,000    1.5    0.72    500,000 
 0.73 to $15.0     375,000    0.7    4.14    375,000 
      24,177,761    6.8   $0.21    13,985,261 

 

 

The compensation expense attributed to the issuance of the options is recognized as they are vested. The employee stock option plan stock options are generally exercisable for ten years from the grant date and vest over various terms from the grant date to three years.

 

As of September 30, 2024, there was no unamortized stock compensation cost related to the stock options granted during the year as the stock options granted during the year ended December 31, 2023 are considered vested. Of the approximately 14 million unvested stock options, the vesting criteria for 7.3 million options is still being evaluated as on the date of this Report, as those options are subject to individual milestone achievements. For more information on the stock options, refer to our 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

The Company amortized $0 stock compensation expense during the nine months ended September 30, 2024 and 2023 on the 2021 and 2022 grants.

 

Warrants

 

The Company has issued warrants in connection with the various financings conducted by the Company. For more information on the warrant issuances, refer to our 2022 Annual Report on Form 10-K/A filed with the SEC on April 17, 2023. The Company issued 10,576,924 warrants related to the November/December 2021 Notes (See Note 6). The fair value of these warrants on issue date amounted to $1,172,753 as calculated using a Black Scholes valuation model.

 

The issuance of warrants to purchase shares of the Company’s Common Stock, including those attributed to debt issuances, as of September 30, 2024 and 2023 are summarized as follows:

 

       Average 
For the nine months ended September 30, 2024  Shares   Exercise Price 
Outstanding at January 1, 2024   61,500,355   $0.15 
Issued during the nine months ended September 30, 2024   3,390,000    0.12 
Exercised / cancelled during the nine months ended September 30, 2024   (33,000,066)   0.15 
Outstanding at September 30, 2024   31,890,289   $0.13 

 

       Average 
For the nine months ended September 30, 2023  Shares   Exercise Price 
Outstanding at January 1, 2023   81,072,855   $0.18 
Issued during the nine months ended September 30, 2023   11,300,000    0.12 
Exercised / cancelled during the nine months ended September 30, 2023   (42,737,500)   0.20 
Outstanding at September 30, 2023   49,635,355   $0.15 

 

The following table summarizes information about warrants outstanding and exercisable at September 30, 2024:

  

    Outstanding and exercisable 
        Weighted-   Weighted-     
        Average   Average     
    Number   Remaining Life   Exercise   Number 
Exercise Price   Outstanding   in Years   Price   Exercisable 
$0.13    961,539    2.15    0.13    961,539 
 0.20    4,373,750    2.49-2.73    0.20    4,373,750 
 0.12    26,555,000    0.77-1.33    0.12    26,555,000 
                       
      31,890,289    1.24   $0.13    31,890,289 

 

 

v3.24.3
INCOME TAXES
9 Months Ended
Sep. 30, 2024
Income Tax Disclosure [Abstract]  
INCOME TAXES

NOTE 13 – INCOME TAXES

 

The Company had gross deferred tax assets, which primarily relate to net operating loss carryforwards. As of December 31, 2023, the Company had gross federal and state net operating loss carryforwards, which are available to offset future taxable income, if any. The Company recorded a valuation allowance in the full amount of its net deferred tax assets since realization of such tax benefits has been determined by our management to be less likely than not. Information on our deferred tax assets and liabilities can be found in our 2023 Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on April 12, 2024.

 

Portions of these carryforwards will expire through 2038, if not otherwise utilized. The Company’s utilization of net operating loss carryforwards could be subject to an annual limitation. as a result of certain past or future events, such as stock sales or other equity events constituting a “change in ownership” under the provisions of Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, and similar state provisions. The annual limitations could result in the expiration of net operating loss carryforwards and tax credits before they can be utilized. We have not performed a formal analysis, but we believe our ability to use such net operating losses and tax credit carryforwards will be subject to annual limitations, due to change of ownership control provisions under Section 382 and 383 of the Internal Revenue Code, which would significantly impact our ability to realize these deferred tax assets.

 

v3.24.3
COMMITMENTS AND CONTINGENCIES
9 Months Ended
Sep. 30, 2024
Commitments and Contingencies Disclosure [Abstract]  
COMMITMENTS AND CONTINGENCIES

NOTE 14 – COMMITMENTS AND CONTINGENCIES

 

Leases

 

Currently, the Company is leasing the office located at 29397 Agoura Road, Suite 107, Agoura Hills, CA 91301 on a month-to-month basis until such time a new office is identified. The Company believes the office is sufficient for its current operations.

 

PointR Merger Contingent Consideration

 

The total purchase price in the PointR Merger of $17,831,427 represented the consideration transferred from the Company and was calculated based on the number of shares of Common Stock plus the preferred shares outstanding but convertible into Common Stock outstanding at the date of the PointR Merger and included $2,625,000 of contingent consideration of shares issuable to PointR shareholders, which could increase to $15 million of contingent consideration, upon achievement of certain milestones. For more information on the PointR Merger Contingent Consideration, 2023 Annual Report on Form 10-K filed with the SEC on April 12, 2024.

 

Third Party Service Provider Claim

 

The Company had disputed a judgement of $20,000 for a non-payment to a third service provider. The Company considered the claim to be immaterial to the financial position of the Company. The Company had filed a counter claim on the third-party service provider as the Company believed the claim to be false and malicious to the interests of the Company. The Honorable Court overruled the previous judgement and the Company had sued the third-party service provider. In March 2024, the Honorable Court’s decision was in favor of the Company due to the reasons described above and the matter has been dismissed. The third party service provider had filed an appeal with the Honorable Court, and the Honorable Court dismissed their appeal.

 

Other claims

 

From time to time, the Company may become involved in certain claims arising in the ordinary course of business. One of the Company’s ex-employees has made a claim against the Company. The Company is evaluating the validity of the claim, as the Company believes that such claim has limited merits and is hopeful to attain a positive outcome for such claim. Since the Company is still evaluating the claim, we are unable to quantify the amount such claim would be settled at, if at all settled.

 

v3.24.3
SUBSEQUENT EVENTS
9 Months Ended
Sep. 30, 2024
Subsequent Events [Abstract]  
SUBSEQUENT EVENTS

NOTE 15 – SUBSEQUENT EVENTS

 

The Company performed an evaluation of subsequent events through November 19, 2024, the date on which the consolidated financial statements were available to be issued. The Company did not identify any material events requiring adjustment to or disclosure in the accompanying consolidated financial statements.

v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
Use of Estimates

Use of Estimates

 

The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, equity-based transactions and disclosure of contingent liabilities at the date of the financial statements and revenues and expense during the reporting period. Actual results could materially differ from those estimates.

 

The Company believes the following critical accounting policies affect its more significant judgments and estimates used in the preparation of the financial statements. Significant estimates include the valuation of goodwill and intangible assets for impairment, deferred tax asset and valuation allowance, and fair value of financial instruments.

 

Cash

Cash

 

As of September 30, 2024, and December 31, 2023 the Company held all its cash in banks. The Company considers investments in highly liquid instruments with a maturity of three months or less to be cash equivalents. The Company did not have any cash equivalents as of September 30, 2024 and December 31, 2023, respectively. Restricted cash consists of certificates of deposits held at banks as collateral.

 

 

Debt issuance Costs and Debt discount

Debt issuance Costs and Debt discount

 

Issuance costs are specific incremental costs that are (1) paid to third parties and (2) directly attributable to the issuance of a debt or equity instrument. The issuance costs attributable to the initial sale of the instrument are offset against the associated proceeds in the determination of the instrument’s initial net carrying amount.

 

Debt issuance costs and debt discounts are being amortized over the lives of the related financings on a basis that approximates the effective interest method. Costs and discounts are presented as a reduction of the related debt in the accompanying balance sheets if related to the issuance of debt or presented as a reduction of additional paid in capital if related to the issuance of an equity instrument. The Company applies the relative fair value to allocate the issuance costs among freestanding instruments that form part of the same transaction.

 

If the Company amends the terms of its convertible notes, the Company reviews and applies the guidance per ASC 470-60 Troubled debt restructurings and ASC 470-50 Debt-Modifications and Extinguishments, evaluates and concludes whether the terms of the agreements were or were not substantially different as of a particular reporting date and accounts the transaction as a debt modification or a troubled debt restructuring.

 

Fair Value of Financial Instruments

Fair Value of Financial Instruments

 

The carrying value of cash, accounts payable and accrued expense approximate their fair values based on the short-term maturity of these instruments. As defined in ASC 820, “Fair Value Measurements and Disclosures,” fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company utilizes market data or assumptions that market participants would use in pricing the asset or liability, including assumptions about risk and the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market corroborated, or generally unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurement) and the lowest priority to unobservable inputs (level 3 measurement). This fair value measurement framework applies at both initial and subsequent measurement.

 

The three levels of the fair value hierarchy defined by ASC 820 are as follows:

 

Level 1 – Quoted prices are available in active markets for identical assets or liabilities as of the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis. Level 1 primarily consists of financial instruments such as exchange-traded derivatives, marketable securities and listed equities.
   
Level 2 – Pricing inputs are other than quoted prices in active markets included in Level 1, which are either directly or indirectly observable as of the reported date. Level 2 includes those financial instruments that are valued using models or other valuation methodologies. These models are primarily industry-standard models that consider various assumptions, including quoted forward prices for commodities, time value, volatility factors and current market and contractual prices for the underlying instruments, as well as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace throughout the full term of the instrument, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. Instruments in this category generally include non-exchange-traded derivatives such as commodity swaps, interest rate swaps, options and collars.
   
Level 3 – Pricing inputs include significant inputs that are generally less observable from objective sources. These inputs may be used with internally developed methodologies that result in management’s best estimate of fair value.

 

The Company did not have any Level 1 or Level 2 assets and liabilities at September 30, 2024 and December 31, 2023.

 

 

Investment in equity securities

Investment in equity securities

 

The following table summarizes the cumulative gross unrealized gains and losses and fair values for long-term investments accounted for at fair value under the fair value option, with the unrealized gains and losses reported within earnings on the Condensed Consolidated Statements of Operation as of September 30, 2024 and December 31, 2023:

 

   Initial Book Value  

Cumulative Gross

Unrealized Gains

  

Cumulative Gross

Unrealized Losses

   Fair Value 
September 30, 2024                    
Investment in GMP Bio (equity securities)  $22,653,225   $                  -   $                       -   $22,653,225 
Total  $22,653,225   $-   $-   $22,653,225 

 

   Initial Book Value  

Cumulative Gross

Unrealized Gains

  

Cumulative Gross

Unrealized Losses

   Fair Value 
December 31, 2023                    
Investment in GMP Bio (equity securities)  $22,640,521   $12,704   $                       -   $22,653,225 
Total  $22,640,521   $12,704   $-   $22,653,225 

 

The table above sets forth a summary of the recording of the initial value of the long-term value of investment in equity securities of GMP Bio, based on a third-party valuation report, and changes in the fair value of such equity securities, if such change occurs, as a Level 3 fair value as of September 30, 2024 and December 31, 2023. During the nine months ended September 30, 2024, there have been no changes in the long-term value of the investment in equity securities of GMP Bio.

 

Derivative Liability

Derivative Liability

 

The Company has certain derivative liabilities associated with its 2019 bridge financing Convertible Notes (see Note 5), which consisted of conversion feature derivatives at September 30, 2024 and December 31, 2023, are Level 3 fair value measurements.

 

The table below sets forth a summary of the changes in the fair value of the Company’s derivative liabilities classified as Level 3 as of September 30, 2024 and December 31, 2023:

 

  

September 30, 2024

Conversion Feature

  

December 31, 2023

Conversion Feature

 
Balance at January 1, 2024 and 2023  $423,214   $198,140 
New derivative liability   -    - 
Reclassification to additional paid in capital from conversion of debt to common stock   -    - 
Change in fair value   (140,828)   225,074 
           
Balance at September 30, 2024 and December 31, 2023  $282,386   $423,214 

 

 

As of September 30, 2024, and December 31, 2023, the Company estimated the fair value of the conversion feature derivatives embedded in the convertible debentures based on assumptions used in the Black-Scholes valuation model. The key valuation assumptions used consists, in part, of the price of the Company’s Common Stock, a risk-free interest rate based on the yield of a Treasury note and expected volatility of the Company’s Common Stock all as of the measurement dates. The Company used the following assumptions to estimate fair value of the derivatives as of September 30, 2024 and December 31, 2023, respectively:

 

   September 30, 2024   December 31, 2023 
   Key   Key 
   Assumptions   Assumptions 
   for fair value   for fair value 
   of conversions   of conversions 
Risk free interest   3.98% - 5.09 %   4.64% - 5.40%
Market price of share  $0.02 - 0.04   $0.03 - 0.05 
Life of instrument in years   0.01    0.01 
Volatility   161.5% - 226.9%   142.45%-236.86%
Dividend yield   0%   0%

 

When the Company changes its valuation inputs for measuring financial liabilities at fair value, either due to changes in current market conditions or other factors, it may need to transfer those liabilities to another level in the hierarchy based on the new inputs used. The Company recognizes these transfers at the end of the reporting period that the transfers occur. For the periods ended September 30, 2024 and 2023, respectively, there were no transfers of financial assets or financial liabilities between the hierarchy levels.

 

The $2,625,000 of contingent consideration, of shares issuable to PointR shareholders which was recorded and associated with the PointR Merger, is also classified as Level 3 fair value measurements. The Company initially recorded the contingency based on a valuation conducted by a third-party valuation expert. The valuation was based on a probability of the completion of certain milestones by PointR for the shareholders to earn additional shares. The Company evaluated the probability of the earning of the milestones and concluded that the probability of achievement of the milestones had not changed, primarily due to the shifting of focus by the Company to develop AI technologies for the COVID-19 pandemic as well as other AI technologies. As such, the Company did not record any change to the valuation during the nine months ended September 30, 2024 or 2023, respectively.

 

Net Income (Loss) Per Share

Net Income (Loss) Per Share

 

Basic net income (loss) per common share is computed by dividing the net income (loss) by the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share includes the effect of Common Stock equivalents (notes convertible into Common Stock, stock options and warrants) when, under either the treasury or if-converted method, such inclusion in the computation would be dilutive. For the three and nine months ended September 30, 2024 and 2023, no equivalent shares of the Common Stock were excluded as the company has a loss and addition of such stock equivalents in the computation would have been anti-dilutive.

 

Stock-Based Compensation

Stock-Based Compensation

 

The Company applies the provisions of ASC 718, Compensation—Stock Compensation (“ASC 718”), which requires the measurement and recognition of compensation expense for all stock-based awards made to employees, including employee stock options, in the statements of operations.

 

For stock options issued to employees and members of the Board of Directors (the “Board”) for their services, the Company estimates the grant date fair value of each option using the Black-Scholes option pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock. For awards subject to service-based vesting conditions, including those with a graded vesting schedule, the Company recognizes stock-based compensation expense equal to the grant date fair value of stock options on a straight-line basis over the requisite service period, which is generally the vesting term. Forfeitures are recorded as they are incurred as opposed to being estimated at the time of grant and revised.

 

 

For warrants issued in connection with fund raising activities, the Company estimates the grant date fair value of each warrant using the Black-Scholes pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the warrant, the expected volatility of the Common Stock consistent with the expected life of the warrant, risk-free interest rates and expected dividend yields of the Common Stock. If the warrants are issued upon termination or cancellation of prior issued warrants, then the Company estimates the grant date fair value of the new warrants using the Black-Scholes pricing model and evaluates whether the new warrants are deemed as equity instruments or liability instruments. If the warrants are deemed to be equity instruments, the Company records stock compensation expense and an addition to additional paid in capital. If, however, the warrants are deemed to be liability instruments, then the fair value is treated as a deemed dividend and credited to additional paid in capital.

 

Impairment of Long-Lived Assets

Impairment of Long-Lived Assets

 

The Company reviews long-lived assets, including definite-lived intangible assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of these assets is determined by comparing the forecasted undiscounted net cash flows of the operation to which the assets relate to the carrying amount. If the operation is determined to be unable to recover the carrying amount of its assets, then these assets are written down first, followed by other long-lived assets of the operation to fair value. Fair value is determined based on discounted cash flows or appraised values, depending on the nature of the assets. For the three and nine months ended September 30, 2024 and 2023, respectively, there were no impairment losses recognized for long-lived assets.

 

Intangible Assets

Intangible Assets

 

The Company records its intangible assets at cost in accordance with ASC 350, Intangibles – Goodwill and Other. The Company reviews the intangible assets for impairment on an annual basis or if events or changes in circumstances indicate it is more likely than not that they are impaired. These events could include a significant change in the business climate, legal factors, a decline in operating performance, competition, sale or disposition of a significant portion of the business, or other factors. If the review indicates the impairment, an impairment loss would be recorded for the difference of the value recorded and the new value. For the nine months ended September 30, 2024 and September 30, 2023, there were no impairment losses recognized for intangible assets. When we sell or contribute properties to unconsolidated arrangements and retain a non-controlling ownership interest in such assets, we recognize the difference between the consideration received and the carrying amount of the asset sold or contributed.

 

Goodwill

Goodwill

 

Goodwill represents the excess of the purchase price of acquired business over the estimated fair value of the identifiable net assets acquired. Goodwill is not amortized but is tested for impairment at least once annually, at the reporting unit level or more frequently if events or changes in circumstances indicate that the asset might be impaired. The goodwill impairment test is applied by performing a qualitative assessment before calculating the fair value of the reporting unit. If, on the basis of qualitative factors, it is considered not more likely than not that the fair value of the reporting unit is less than the carrying amount, further testing of goodwill for impairment would not be required. Otherwise, goodwill impairment is tested using a two-step approach.

 

The first step involves comparing the fair value of the reporting unit to its carrying amount. If the fair value of the reporting unit is determined to be greater than its carrying amount, there is no impairment. If the reporting unit’s carrying amount is determined to be greater than the fair value, the second step must be completed to measure the amount of impairment, if any. The second step involves calculating the implied fair value of goodwill by deducting the fair value of all tangible and intangible assets, excluding goodwill, of the reporting unit from the fair value of the reporting unit as determined in step one. The implied fair value of the goodwill in this step is compared to the carrying value of goodwill. If the implied fair value of the goodwill is less than the carrying value of the goodwill, an impairment loss equivalent to the difference is recorded. For the three and nine months ended September 30, 2024, we recorded an impairment loss of approximately $3 million on our goodwill. For the three and nine months ended September 30, 2023, we recorded an impairment loss of approximately $0 and $6.1 million, respectively, based on the difference between the carrying value of our goodwill as against the market capitalization of the Company. For more information on goodwill and impairment, refer to Note 3 to these Notes to the Consolidated Financial Statements.

 

 

Derivative Financial Instruments Indexed to the Company’s Common Stock

Derivative Financial Instruments Indexed to the Company’s Common Stock

 

We have generally issued derivative financial instruments, such as warrants, in connection with our equity offerings. We evaluate the terms of these derivative financial instruments in order to determine their accounting treatment in our financial statements. Key considerations include whether the financial instruments are freestanding and whether they contain conditional obligations. If the warrants are freestanding, do not contain conditional obligations and meet other classification criteria, we account for the warrants as an equity instrument. However, if the warrants contain conditional obligations, then we account for the warrants as a liability until the conditional obligations are met or are no longer relevant. Because no established market prices exist for the warrants that we issue in connection with our equity offerings, we must estimate the fair value of the warrants based on the price of our Common Stock as of December 31 each year, which is as inherently subjective as it is for stock options, and for similar reasons as noted in the stock-based compensation section above. For financial instruments which are accounted for as a liability, we report any changes in their estimated fair values as gains or losses in our Consolidated Statement of Income.

 

Convertible Instruments

Convertible Instruments

 

The Company evaluates and accounts for conversion options embedded in its convertible instruments in accordance with ASC 815 “Derivatives and Hedging”.

 

ASC 815 generally provides three criteria that, if met, require companies to bifurcate conversion options from their host instruments and account for them as free-standing derivative financial instruments. These three criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur, and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. Professional standards also provide an exception to this rule when the host instrument is deemed to be conventional as defined under professional standards as “The Meaning of Conventional Convertible Debt Instrument.”

 

The Company accounts for convertible instruments (when it has determined that the embedded conversion options should not be bifurcated from their host instruments) in accordance with ASC 470-20 “Debt – Debt with Conversion and Other Options.” Accordingly, the Company records, when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments based upon the differences between the fair value of the underlying Common Stock at the commitment date of the note transaction and the effective conversion price embedded in the note. Original issue discounts (“OID”) under these arrangements are amortized over the term of the related debt to their earliest date of redemption. The Company also records when necessary deemed dividends for the intrinsic value of conversion options embedded in preferred shares based upon the differences between the fair value of the underlying Common Stock at the commitment date of the note transaction and the effective conversion price embedded in the note.

 

ASC 815-40 “Derivatives and Hedging – Contracts in Entity’s Own Equity” provides that, among other things, generally, if an event is not within the entity’s control could or require net cash settlement, then the contract shall be classified as an asset or a liability.

 

 

Variable Interest Entity (VIE) Accounting

Variable Interest Entity (VIE) Accounting

 

The Company evaluates its ownership, contractual relationships and other interests in entities to determine the nature and extent of the interests, whether such interests are variable interests and whether the entities are VIEs in accordance with ASC 810, Consolidations. These evaluations can be complex and involve Management judgment as well as the use of estimates and assumptions based on available historical information, among other factors. Based on these evaluations, if the Company determines that it is the primary beneficiary of a VIE, the entity is consolidated into the financial statements. At September 30, 2024 and September 30, 2023, the Company identified EdgePoint to be the Company’s sole VIE. At September 30, 2024 and September 30, 2023, the Company’s ownership percentage of EdgePoint was 29% and 29%, respectively. The VIE’s net assets were less than $0.1 million at September 30, 2024 and December 31, 2023, respectively.

 

Investments - Equity Method

Investments - Equity Method

 

The Company accounts for equity method investments at cost, adjusted for the Company’s share of the investee’s earnings or losses, which are reflected in the consolidated statements of operations. The Company periodically reviews the investments for other than temporary declines in fair value below cost and more frequently when events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. The Investment in GMP Bio represents the investment into equity securities for which the Company elected the fair value option pursuant to ASC 825-10-15 and subsequent fair value changes in the GMP Bio shares shall be included in the result from other income. Refer to Note 6 to these Notes to the Consolidated Financial Statements.

 

Joint Venture agreement

Joint Venture agreement

 

We have equity interest in unconsolidated arrangement that is primarily engaged in the business of drug discovery, development, and commercialization, including but not limited to development and commercialization of TGF-beta therapeutics as well as establishing and operating contract development and manufacturing organization (“CDMO”) facilities and capabilities. The Company first reviews the arrangement to determine if it meets the definition of an accounting joint venture pursuant to ASC 323-10-20. In order to meet the definition of a joint venture, the arrangement must have all of the following characteristics, (i) the arrangement is organized within a separate legal entity, (ii) the entity is under the joint control of the venturers, (iii) the venturers must be able to exercise joint control through their equity investments, (iv) the qualitative characteristics of the entity, including its purpose and design must be consistent with the definition of a joint venture.

 

We consolidate arrangements that are considered to be VIEs where we are the primary beneficiary. We analyze our investments in joint ventures to determine if the joint venture is considered a VIE and would require consolidation. We (i) evaluate the sufficiency of the total equity investment at risk, (ii) review the voting rights and decision-making authority of the equity investment holders as a group and whether there are limited partners (or similar owning entities) that lack substantive participating or kick out rights, guaranteed returns, protection against losses, or capping of residual returns within the group and (iii) establish whether activities within the venture are on behalf of an investor with disproportionately few voting rights in making this VIE determination.

 

To the extent that we own interests in a VIE and we (i) have the power to direct the activities that most significantly impact the economic performance of the VIE and (ii) have the obligation or rights to absorb losses or receive benefits that could potentially be significant to the VIE, then we would be determined to be the primary beneficiary and would consolidate the VIE. To the extent that we own interests in a VIE, then at each reporting period, we re-assess our conclusions as to which, if any, party within the VIE is considered the primary beneficiary.

 

To the extent that our arrangements do not qualify as VIEs, they are consolidated if we control them through majority ownership interests or if we are the managing entity (general partner or managing member) and our partner does not have substantive participating rights. Control is further demonstrated by our ability to unilaterally make significant operating decisions, refinance debt, and sell the assets of the joint venture without the consent of the non-managing entity and the inability of the non-managing entity to remove us from our role as the managing entity.

 

We use the equity method of accounting for those arrangements where we exercise significant influence but do not have control. Under the equity method of accounting, our investment in each arrangement is included on our consolidated balance sheet; however, the assets and liabilities of the joint ventures for which we use the equity method are not included on our consolidated balance sheet.

 

 

When we sell or contribute properties to unconsolidated arrangements and retain a non-controlling ownership interest in such assets, we recognize the difference between the consideration received and the carrying amount of the asset sold or contributed when its derecognition criteria are met. The equity method investment we retain in such partial sale transactions is noncash consideration and is measured at fair value. As a result, the accounting for a partial sale will result in the recognition of a full gain or loss.

 

When circumstances indicate there may have been a reduction in the value of an equity investment, we evaluate whether the loss in value is other than temporary. If we conclude it is other than temporary, we recognize an impairment charge to reflect the equity investment at fair value.

 

The Company elected the fair value option under the fair value option Subsection of Section 825-10-15 to account for its equity-method investment as the Company believes that the fair value option is most appropriate for a company in the biotechnology industry, The fair value option is more appropriate for companies that are involved in extensive and usually very expensive research and development efforts, which are not appropriately reflected in the market value or reflective of the true value of the development activities of the company.

 

Embedded debt costs in convertible debt instruments

Embedded debt costs in convertible debt instruments

 

In August 2020, the FASB issued “ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40)” (“ASU 2020-06”) which simplifies the accounting for convertible instruments. The guidance removes certain accounting models which separate the embedded conversion features from the host contract for convertible instruments. Either a modified retrospective method of transition or a fully retrospective method of transition was permissible for the adoption of this standard. Update No. 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption was permitted no earlier than the fiscal year beginning after December 15, 2020. The Company adopted ASU 2020-06 effective January 1, 2023 and has removed the effects of any embedded conversion features from certain of our convertible instruments as of that date.

 

Revenue Recognition

Revenue Recognition

 

The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers (Topic 606).

 

Under Topic 606, the Company recognizes revenue when its customers obtain control of the promised good or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. The Company applies the following five-step: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation.

 

At contract inception, once the contract is determined to be within the scope of Topic 606, the Company identifies the performance obligation(s) in the contract by assessing whether the goods or services promised within each contract are distinct. The Company then recognizes revenue for the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

 

The Company anticipates generating revenues from rendering services to other third-party customers for the development of certain drug products and/or in connection with certain out-licensing agreements. In the case of services rendered for development of the drugs, revenue is recognized upon the achievement of the performance obligations or over time on a straight-line basis over the extended service period. In the case of out-licensing contracts, the Company records revenues either upon achievement of certain pre-defined milestones, when there is no obligation of the Company achieve any performance obligations in connection with the said pre-defined milestones, or upon achievement of the performance obligations if the milestones require the Company to provide the performance obligations.

 

The Company occasionally collects advance payments from customers toward commitments to provide services or performance obligations, in which case the advance payment is recorded as a liability until the obligations are fulfilled and revenue is recognized.

 

 

Research & Development Costs

Research & Development Costs

 

In accordance with ASC 730-10-25 “Research and Development”, research and development costs are charged to expense as and when incurred.

 

Recent Accounting Pronouncements

Recent Accounting Pronouncements

 

In August 2020, the FASB issued “ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40)” (“ASU 2020-06”) which simplifies the accounting for convertible instruments. The guidance removes certain accounting models which separate the embedded conversion features from the host contract for convertible instruments. Either a modified retrospective method of transition or a fully retrospective method of transition was permissible for the adoption of this standard. Update No. 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption was permitted no earlier than the fiscal year beginning after December 15, 2020. The Company adopted ASU 2020-06 effective January 1, 2023 and recorded approximately $0.5 million as a reduction to the additional paid in capital and added approximately $0.3 million to the opening retained earnings in accordance with the authoritative guidance under ASU 2020-06.

 

All other newly issued but not yet effective accounting pronouncements have been deemed to be not applicable or immaterial to the Company.

v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
SCHEDULE OF UNREALIZED GAINS AND LOSSES

 

   Initial Book Value  

Cumulative Gross

Unrealized Gains

  

Cumulative Gross

Unrealized Losses

   Fair Value 
September 30, 2024                    
Investment in GMP Bio (equity securities)  $22,653,225   $                  -   $                       -   $22,653,225 
Total  $22,653,225   $-   $-   $22,653,225 

 

   Initial Book Value  

Cumulative Gross

Unrealized Gains

  

Cumulative Gross

Unrealized Losses

   Fair Value 
December 31, 2023                    
Investment in GMP Bio (equity securities)  $22,640,521   $12,704   $                       -   $22,653,225 
Total  $22,640,521   $12,704   $-   $22,653,225 
SUMMARY OF CHANGES IN FAIR VALUE OF DERIVATIVE LIABILITIES

The table below sets forth a summary of the changes in the fair value of the Company’s derivative liabilities classified as Level 3 as of September 30, 2024 and December 31, 2023:

 

  

September 30, 2024

Conversion Feature

  

December 31, 2023

Conversion Feature

 
Balance at January 1, 2024 and 2023  $423,214   $198,140 
New derivative liability   -    - 
Reclassification to additional paid in capital from conversion of debt to common stock   -    - 
Change in fair value   (140,828)   225,074 
           
Balance at September 30, 2024 and December 31, 2023  $282,386   $423,214 
SUMMARY OF ESTIMATE FAIR VALUE OF DERIVATIVE LIABILITIES

 

   September 30, 2024   December 31, 2023 
   Key   Key 
   Assumptions   Assumptions 
   for fair value   for fair value 
   of conversions   of conversions 
Risk free interest   3.98% - 5.09 %   4.64% - 5.40%
Market price of share  $0.02 - 0.04   $0.03 - 0.05 
Life of instrument in years   0.01    0.01 
Volatility   161.5% - 226.9%   142.45%-236.86%
Dividend yield   0%   0%
v3.24.3
INTANGIBLE ASSETS AND GOODWILL (Tables)
9 Months Ended
Sep. 30, 2024
Intangible Assets And Goodwill  
SUMMARY OF GOODWILL

A summary of our goodwill as of September 30, 2024 and December 31, 2023 is shown below:

 

  

September 30,

2024

  

December 31,

2023

 
Balance at January 1, 2024 and 2023  $5,988,230   $12,071,376 
Less: Goodwill impairment due to market capitalization   (3,200,000)   (6,083,146)
           
Balance at September 30, 2024 and December 31, 2023  $2,788,230   $5,988,230 
v3.24.3
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables)
9 Months Ended
Sep. 30, 2024
Payables and Accruals [Abstract]  
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES

Accounts payable and accrued expense consists of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
         
Accounts payable  $1,692,263   $1,656,613 
Accrued expense   769,860    780,708 
Accounts payable and accrued liabilities  $2,462,123   $2,437,321 

 

  

September 30,

2024

  

December 31,

2023

 
           
Accounts payable – related party  $345,543   $344,099 
v3.24.3
CONVERTIBLE DEBENTURES, NOTES AND OTHER DEBT (Tables)
9 Months Ended
Sep. 30, 2024
Debt Disclosure [Abstract]  
SCHEDULE OF CONVERTIBLE DEBENTURES AND NOTES, NET OF DISCOUNT

As of September 30, 2024 and December 31, 2023, special purchase agreements (SPAs) with convertible debentures and notes, net of debt discount and including accrued interest, if any, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
Current Debt          
Convertible debentures          
10% Convertible note payable – Bridge Investor  $35,556   $35,556 
10% Convertible note payable – Related Party   164,444    164,444 
10% Convertible note payable – Bridge Investor   200,000    200,000 
Convertible note payable   400,000    400,000 
Fall 2019 Notes          
5% Convertible note payable – Stephen Boesch   132,708    128,958 
5% Convertible note payable – Related Party   310,608    301,233 
5% Convertible note payable – Dr. Sanjay Jha (Through his family trust)   310,128    300,753 
5% Convertible note payable – CEO & CFO – Related Parties   101,634    98,559 
5% Convertible note payable – Bridge Investors   208,222    201,922 
Convertible note payable   1,063,300    1,031,425 
August 2021 Convertible Notes          
5% Convertible note – Autotelic Inc– Related Party   289,427    280,052 
5% Convertible note – Bridge investors   432,406    418,399 
5% Convertible note – CFO – Related Party   86,832    84,018 
 Convertible note payable    808,665    782,469 
JH Darbie PPM Debt          
16% Convertible Notes – Non-related parties   -    311,693 
16% Convertible Notes – CEO – Related Party   -    - 
Convertible note payable   -    311,693 
           
November/December 2021 & March 2022 Notes          
16% Convertible Notes – Accredited Investors   225,296    233,393 
           
Debt for Clinical Trials – Forever Prosperity ( Formerly GMP)          
2% Convertible Notes – Forever Prosperity   4,817,562    4,750,000 
           
May 2022 Note          
16% Convertible Notes – Accredited Investors   972,500    1,401,283 
           
Other Debt          
Short term debt – Bridge investors   210,000    210,000 
Short term debt from CFO – Related Party   50,050    35,050 
Short term debt – Autotelic Inc. – Related Party   2,070,000    1,470,000 
Short Term Debt from CEO – Related Party   50,000    50,000 
 Short term debt    2,380,050    1,765,050 
Total of short term convertible debentures & notes and other debt  $10,667,373    10,675,313 

 

  

September 30,

2024

  

December 31,

2023

 
Long Term Debt          
JH Darbie PPM 2 Debt          
16% Convertible Notes - Non-related parties   2,142,849    1,773,468 
16% Convertible Notes – CEO – Related Party   125,000    125,000 
 Convertible note payable    2,267,849    1,898,468 
SCHEDULE OF CONVERTIBLE NOTES, NET OF DISCOUNT

As of September 30, 2024, and December 31, 2023, the August 2021 convertible notes, inclusive of accrued interest, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
Autotelic Related party convertible note, 5% coupon December 2023  $289,427   $280,052 
Accredited investors convertible note, 5% coupon December 2023   432,406    418,399 
CFO Related party convertible note, 5% coupon December 2023   86,832    84,018 
Convertible notes  $808,665   $782,469 
 

As of September 30, 2024, and December 31, 2023, the March 2022 Fourth Man convertible note, including accrued interest and net of debt discount, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
         
Fourth Man Convertible note, 16% coupon March 2023 inclusive of accrued interest and default provision  $225,296   $233,393 
Unamortized debt discount   -    - 
Convertible notes, net  $225,296    233,393 
  

As of September 30, 2024, and December 31, 2023, the May 2022 Mast Financing, net of debt discount, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
Mast Hill Convertible note, 12% coupon May 2023, inclusive of accrued interest and penalty  $972,500   $905,484 
Convertible notes, net  $972,500   $905,484 
  

As of September 30, 2024, and December 31, 2023, convertible note under the June 2022 Blue Lake Financing, net of debt discount, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
Blue Lake Convertible note, 16% coupon June 2023, inclusive of accrued interest and penalty  $-   $495,800 
Convertible notes, net  $-   $495,800 
 
SCHEDULE OF SHORT-TERM LOANS

As of September 30, 2024 compared to December 31, 2023, other short-term advances consist of the following amounts obtained from various employees and related parties:

 

Other Advances 

September 30,

2024

  

December 31,

2023

 
Short term advance from CFO – Related Party  $50,050   $35,050 
Short term advance from CEO – Related Party   50,000    50,000 
Short term advances – bridge investors & others   210,000    210,000 
Short term advances – Autotelic Inc. – Related Party   2,070,000    1,470,000 
Short term advance  $2,380,050   $1,765,050 
v3.24.3
JOINT VENTURE WITH GMP BIO AND AFFILIATES, EQUITY METHOD INVESTMENT (Tables)
9 Months Ended
Sep. 30, 2024
Equity Method Investments and Joint Ventures [Abstract]  
SCHEDULE OF CHANGE IN FAIR VALUE OF OUR INVESTMENT

A summary of the change in fair value of our investment in GMP Bio, as of September 30, 2024 and December 31, 2023 is shown below:

 

  

September 30,

2024

  

December 31,

2023

 
Balance at January 1, 2024 and 2023  $22,653,225   $22,640,521 
Add: change in fair value of investment in GMP Bio   -    12,704 
           
Balance at December 31, 2024 and 2023  $22,653,225   $22,653,225 
v3.24.3
PRIVATE PLACEMENT AND JH DARBIE FINANCING (Tables)
9 Months Ended
Sep. 30, 2024
Private Placement And Jh Darbie Financing  
SCHEDULE OF FUNDS RECEIVED UNDER THE SUBSCRIPTION AGREEMENT

As September 30, 2024 and December 31, 2023 funds received under the JH Darbie Financing, net of debt discount, consist of the following amounts:

 

  

September 30,

2024

  

December 31,

2023

 
Convertible promissory notes          
Subscription agreements - accredited investors  $-   $311,693 
Subscription agreements – related party   -    - 
Total convertible promissory notes  $-   $311,693 
v3.24.3
PRIVATE PLACEMENT -2 (PPM-2) AND JH DARBIE FUNDING (Tables)
9 Months Ended
Sep. 30, 2024
Private Placement -2 Ppm-2 And Jh Darbie Funding  
SCHEDULE OF FUNDS RECEIVED UNDER THE SUBSCRIPTION AGREEMENT

As of September 30, 2024 and December 31, 2023, the PPM2 - JH Darbie Financing, net of debt discounts, consisted of the following amounts:

 

  

September 30,

2024

   December 31,
2023
 
Convertible promissory notes          
PPM-2 Darbie Financing, inclusive of accrued interest, including related parties  $2,267,849   $1,898,468 
Total PPM-2 Darbie Financing, net of discounts  $2,267,849   $1,898,468 
SCHEDULE OF FAIR VALUE WARRANTS

  

Expected Term   2 years 
Expected volatility   173%
Risk-free interest rate   4.29%
Dividend   0.00%
v3.24.3
STOCK-BASED COMPENSATION (Tables)
9 Months Ended
Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]  
SCHEDULE OF COMPENSATION BASED STOCK OPTION ACTIVITY

Compensation based stock option activity for qualified and unqualified stock options are summarized as follows:

 

       Weighted 
       Average 
For the nine months ended September 30, 2024  Shares   Exercise Price 
Outstanding at January 1, 2024   24,177,761   $0.21 
Expired or cancelled   -    - 
Outstanding at September 30, 2024   24,177,761    0.21 
Options exercisable at September 30, 2024   13,985,261    0.10 

 

       Weighted 
       Average 
For the nine months ended September 30, 2023  Shares   Exercise Price 
Outstanding at January 1, 2023   25,690,261   $0.23 
Expired or cancelled   (1,512,500)   0.46 
           
Outstanding at September 30, 2023   24,177,761    0.21 
SCHEDULE OF OPTIONS TO PURCHASE SHARES OF COMMON STOCK OUTSTANDING AND EXERCISABLE

The following table summarizes information about options to purchase shares of the Company’s Common Stock outstanding and exercisable at September 30, 2024:

  

Exercise prices  

Outstanding

Options

  

Weighted-

Average

Remaining Life

In Years

  

Weighted-

Average

Exercise

Price

  

Number

Exercisable

 
                  
$0.1 to $0.15     16,250,000    7.5   $0.12    6,057,500 
 0.16 to $0.21     5,502,761    6.8    0.16    5,502,761 
 0.22 to $0.37     1,550,000    3.3    0.28    1,550,000 
 0.38 to $0.72     500,000    1.5    0.72    500,000 
 0.73 to $15.0     375,000    0.7    4.14    375,000 
      24,177,761    6.8   $0.21    13,985,261 
SCHEDULE OF WARRANTS ACTIVITY

The issuance of warrants to purchase shares of the Company’s Common Stock, including those attributed to debt issuances, as of September 30, 2024 and 2023 are summarized as follows:

 

       Average 
For the nine months ended September 30, 2024  Shares   Exercise Price 
Outstanding at January 1, 2024   61,500,355   $0.15 
Issued during the nine months ended September 30, 2024   3,390,000    0.12 
Exercised / cancelled during the nine months ended September 30, 2024   (33,000,066)   0.15 
Outstanding at September 30, 2024   31,890,289   $0.13 

 

       Average 
For the nine months ended September 30, 2023  Shares   Exercise Price 
Outstanding at January 1, 2023   81,072,855   $0.18 
Issued during the nine months ended September 30, 2023   11,300,000    0.12 
Exercised / cancelled during the nine months ended September 30, 2023   (42,737,500)   0.20 
Outstanding at September 30, 2023   49,635,355   $0.15 
SCHEDULE OF WARRANTS OUTSTANDING AND EXERCISABLE

The following table summarizes information about warrants outstanding and exercisable at September 30, 2024:

  

    Outstanding and exercisable 
        Weighted-   Weighted-     
        Average   Average     
    Number   Remaining Life   Exercise   Number 
Exercise Price   Outstanding   in Years   Price   Exercisable 
$0.13    961,539    2.15    0.13    961,539 
 0.20    4,373,750    2.49-2.73    0.20    4,373,750 
 0.12    26,555,000    0.77-1.33    0.12    26,555,000 
                       
      31,890,289    1.24   $0.13    31,890,289 
v3.24.3
SCHEDULE OF UNREALIZED GAINS AND LOSSES (Details) - USD ($)
9 Months Ended 12 Months Ended
Sep. 30, 2024
Dec. 31, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Investment in equity securities, initial book value $ 22,653,225 $ 22,640,521
Investment in equity securities, unrealized gains 12,704
Investment in equity securities, unrealized losses
Investment in equity securities, fair value 22,653,225 22,653,225
GMP Bio [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Investment in equity securities, initial book value 22,653,225 22,640,521
Investment in equity securities, unrealized gains 12,704
Investment in equity securities, unrealized losses
Investment in equity securities, fair value $ 22,653,225 $ 22,653,225
v3.24.3
SUMMARY OF CHANGES IN FAIR VALUE OF DERIVATIVE LIABILITIES (Details) - USD ($)
9 Months Ended 12 Months Ended
Sep. 30, 2024
Dec. 31, 2023
Accounting Policies [Abstract]    
Balance at January 1, 2024 and 2023 $ 423,214 $ 198,140
New derivative liability
Reclassification to additional paid in capital from conversion of debt to common stock
Change in fair value (140,828) 225,074
Balance at September 30, 2024 and December 31, 2023 $ 282,386 $ 423,214
v3.24.3
SUMMARY OF ESTIMATE FAIR VALUE OF DERIVATIVE LIABILITIES (Details)
9 Months Ended 12 Months Ended
Sep. 30, 2024
$ / shares
Dec. 31, 2023
$ / shares
Measurement Input, Risk Free Interest Rate [Member] | Minimum [Member]    
Property, Plant and Equipment [Line Items]    
Dividend yield 3.98 4.64
Measurement Input, Risk Free Interest Rate [Member] | Maximum [Member]    
Property, Plant and Equipment [Line Items]    
Dividend yield 5.09 5.40
Measurement Input, Share Price [Member] | Minimum [Member]    
Property, Plant and Equipment [Line Items]    
Dividend yield 0.02 0.03
Measurement Input, Share Price [Member] | Maximum [Member]    
Property, Plant and Equipment [Line Items]    
Dividend yield 0.04 0.05
Measurement Input, Expected Term [Member]    
Property, Plant and Equipment [Line Items]    
Life of instrument in years 3 days 3 days
Measurement Input, Price Volatility [Member] | Minimum [Member]    
Property, Plant and Equipment [Line Items]    
Dividend yield 161.5 142.45
Measurement Input, Price Volatility [Member] | Maximum [Member]    
Property, Plant and Equipment [Line Items]    
Dividend yield 226.9 236.86
Measurement Input, Expected Dividend Rate [Member]    
Property, Plant and Equipment [Line Items]    
Dividend yield 0 0
v3.24.3
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended 7 Months Ended 9 Months Ended 12 Months Ended
Jun. 30, 2022
Feb. 29, 2024
Jan. 31, 2024
Oct. 31, 2023
Sep. 30, 2023
Jul. 31, 2023
Jun. 30, 2022
Dec. 31, 2021
Nov. 30, 2021
May 31, 2021
Sep. 30, 2024
Sep. 30, 2023
Jan. 31, 2024
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Dec. 31, 2022
Mar. 31, 2024
May 31, 2022
Mar. 31, 2022
Feb. 28, 2022
Jan. 31, 2022
Aug. 31, 2021
Jun. 30, 2020
Conversion fee, values   $ 35,000                                            
Warrants issued to purchase shares                     10,576,924     10,576,924                    
Warrants issuance cost                                 $ 2,900,000              
Purchase of warrants                     31,890,289     31,890,289                    
Common stock, par value                     $ 0.01     $ 0.01   $ 0.01                
Debt instrumental interest rate   125.00%                                            
Conversion fee, shares   500,000                                            
Debt instrument amount                           $ 1,063,300   $ 1,031,425                
Net accumulated losses                     $ (3,304,486) $ 115,309   (3,922,998) $ (7,167,110)                  
Working capital deficit                     16,100,000     16,100,000                    
Net cash used in operating activities                           600,000                    
Autotelic Inc [Member]                                                
Proceeds from related party debt                           600,000                    
Vyoung Trieu [Member]                                                
Proceeds from related party debt                           15,000                    
Oncotelic Warrant [Member]                                                
Warrants issued to purchase shares                                         33,000,000      
Purchase of common stock, value                                         $ 50,000      
Warrant [Member]                                                
Purchase of warrants                                   33,000,000            
Common Stock [Member]                                                
Conversion fee, values                           $ 35,000                    
Conversion fee, shares                           500,000                    
Biomedical Advanced Research and Development Authority [Member]                                                
Investment company, general partner advisory service                           $ 750,000                    
Supplemental Agreement [Member] | Golden Mountain Partners LLC [Member]                                                
Investment company, grant amount                           $ 1,200,000                    
JH Darbie Placement Agreement [Member]                                                
Debt conversion description                         Based on the placement agent agreement, JH Darbie was entitled to a non-refundable $25,000 fee to start the due diligence process and 2% due diligence fees and 13% commissions on all subsequent conversions or new funding. In addition, the Company provided warrant coverage equal to 13 % of all of the units sold to JH Darbie. As the Company converted an aggregate of 94 units, JH Darbie was entitled to earn a total of 3,055,000 warrants. A total of 5 unit holders under the PPM-1 opted not to participate in the PPM-2                      
JH Darbie Placement Agreement [Member] | Warrant [Member]                                                
Common stock new share issued                         250,000                      
JH Darbie Placement Agreement [Member] | Accredited Investors [Member]                                                
Conversion fee, values       $ 1,050,000.00 $ 1,000,000.0 $ 1,000,000.0                                    
Debt conversion description         JH Darbie has the right to sell/convert a minimum of 10 Units and a maximum of 200 Units on a best-efforts basis JH Darbie has the right to sell/convert a minimum of 10 Units and a maximum of 200 Units on a best-efforts basis                                    
JH Darbie Placement Agreement [Member] | Additionally Accredited Investors [Member]                                                
Conversion fee, values     $ 300,000                                          
Equity Purchase Agreement [Member] | Peak One Opportunity Fund, L.P [Member]                                                
Common shares issued for cash                   $ 10,000,000.0                            
Common stock, par value                   $ 0.01                            
Note Purchase Agreements [Member] | Autotelic Inc [Member]                                                
Debt instrument face amount                                             $ 698,500  
Debt instrumental interest rate                                             5.00%  
Securities Purchase Agreements [Member]                                                
Common stock, par value               $ 0.01 $ 0.01                              
Debt instrument face amount               $ 250,000 $ 250,000                   $ 600,000 $ 250,000        
Proceeds from convertible debt               $ 1,250,000 $ 1,250,000                              
Common stock new share issued             4,025,000                                  
Securities Purchase Agreement [Member]                                                
Debt instrument face amount $ 340,000           $ 340,000                                  
Common stock new share issued                           7.6                    
Debt instrument amount $ 531,000                                              
Securities Purchase Agreement [Member] | Fourth Man LLC [Member]                                                
Convertible debt                               127,000                
Conversion fee, shares                           1,820,395                    
Securities Purchase Agreement and Purchase Agreement [Member] | Golden Mountain Partners [Member]                                                
Debt instrument face amount                                           $ 4,500,000   $ 4,500,000
Since Inception Date [Member]                                                
Net accumulated losses                               $ 37,400,000                
Point R merger agreement [Member]                                                
Working capital deficit                     $ 2,600,000     $ 2,600,000                    
v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)
3 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Jan. 01, 2023
Impairment of intangible assets     $ 0 $ 0    
Goodwill impairment loss $ 3,200,000 $ 3,200,000 $ 6,083,146 $ 6,083,146  
Variable interest entity percentage     29.00% 29.00%    
Net assets 26,782,245   $ 26,782,245   30,014,952  
Additional paid in capital 42,219,400   42,219,400   41,655,026  
Opening retained earnings (37,439,735)   (37,439,735)   (33,516,736)  
Accounting Standards Update 2020-06 [Member]            
Additional paid in capital   500,000   $ 500,000   $ 109,349
Opening retained earnings   $ 300,000   $ 300,000   $ 78,460
Consolidated Entity, Excluding Consolidated VIE [Member]            
Net assets $ 100,000   100,000   $ 100,000  
Fair Value, Inputs, Level 3 [Member] | PointR [Member]            
Contigent consideration     $ 2,625,000      
v3.24.3
SUMMARY OF GOODWILL (Details) - USD ($)
3 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Intangible Assets And Goodwill          
Balance at January 1, 2024 and 2023     $ 5,988,230 $ 12,071,376 $ 12,071,376
Less: Goodwill impairment due to market capitalization $ (3,200,000) (3,200,000) $ (6,083,146) (6,083,146)
Balance at September 30, 2024 and December 31, 2023 $ 2,788,230   $ 2,788,230   $ 5,988,230
v3.24.3
INTANGIBLE ASSETS AND GOODWILL (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended 12 Months Ended
Apr. 30, 2019
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Dec. 31, 2022
Nov. 30, 2019
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]                
Goodwill   $ 2,788,230   $ 2,788,230   $ 5,988,230 $ 12,071,376  
Goodwill impairment (See note 2 and 3)   3,200,000 3,200,000 $ 6,083,146 6,083,146    
In Process Research and Development [Member]                
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]                
Intangible asset, net   $ 1,101,760   $ 1,101,760   $ 1,101,760    
Merger Agreement [Member]                
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]                
Goodwill $ 4,900,000              
Derecognized goodwill $ 4,900,000              
Merger Agreement [Member] | PointR [Member]                
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]                
Goodwill               $ 16,182,456
v3.24.3
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) - USD ($)
Sep. 30, 2024
Dec. 31, 2023
Defined Benefit Plan Disclosure [Line Items]    
Accounts payable $ 1,692,263 $ 1,656,613
Accrued expense 769,860 780,708
Accounts payable and accrued liabilities 2,462,123 2,437,321
Related Party [Member]    
Defined Benefit Plan Disclosure [Line Items]    
Accounts payable – related party $ 345,543 $ 344,099
v3.24.3
SCHEDULE OF CONVERTIBLE DEBENTURES AND NOTES, NET OF DISCOUNT (Details) - USD ($)
Sep. 30, 2024
Dec. 31, 2023
Short-Term Debt [Line Items]    
 Short term debt $ 2,380,050 $ 1,765,050
Total of short term convertible debentures & notes and other debt 10,667,373 10,675,313
Convertible Debentures [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 400,000 400,000
Fall 2019 Notes [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 1,063,300 1,031,425
August 2021 Convertible Notes [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 808,665 782,469
JH Darbie PPM Debt [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 311,693
JH Darbie PPM 2 Debt [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 2,267,849 1,898,468
10% Convertible note payable – Bridge Investor [Member] | Convertible Debentures [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 35,556 35,556
10% Convertible note payable – Related Party [Member] | Convertible Debentures [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 164,444 164,444
10% Convertible note payable – Bridge Investor [Member] | Convertible Debentures [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 200,000 200,000
5% Convertible note payable – Stephen Boesch [Member] | Fall 2019 Notes [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 132,708 128,958
5% Convertible note payable – Related Party [Member] | Fall 2019 Notes [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 310,608 301,233
5% Convertible note payable – Dr. Sanjay Jha (Through his family trust) [Member] | Fall 2019 Notes [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 310,128 300,753
5% Convertible note payable – CEO & CFO – Related Parties [Member] | Fall 2019 Notes [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 101,634 98,559
5% Convertible note payable – Bridge Investors [Member] | Fall 2019 Notes [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 208,222 201,922
5% Convertible note – Autotelic Inc– Related Party [Member] | August 2021 Convertible Notes [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 289,427 280,052
5% Convertible note – Bridge investors [Member] | August 2021 Convertible Notes [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 432,406 418,399
5% Convertible note – CFO – Related Party [Member] | August 2021 Convertible Notes [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 86,832 84,018
16% Convertible Notes – Non-related parties [Member] | JH Darbie PPM Debt [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 311,693
16% Convertible Notes – Non-related parties [Member] | JH Darbie PPM 2 Debt [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 2,142,849 1,773,468
16% Convertible Notes – CEO – Related Party [Member] | JH Darbie PPM Debt [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable
16% Convertible Notes – CEO – Related Party [Member] | JH Darbie PPM 2 Debt [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 125,000 125,000
16% Convertible Notes – Accredited Investors [Member] | November/December 2021 & March 2022 Notes [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 225,296 233,393
16% Convertible Notes – Accredited Investors [Member] | May and June 2022 Note [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 972,500 1,401,283
2% Convertible Notes – Forever Prosperity [Member] | Debt for Clinical Trials – Forever Prosperity (Formerly GMP) [Member]    
Short-Term Debt [Line Items]    
 Convertible note payable 4,817,562 4,750,000
Short term debt – Bridge investors [Member] | Other Debt [Member]    
Short-Term Debt [Line Items]    
 Short term debt 210,000 210,000
Short term debt from CFO – Related Party [Member] | Other Debt [Member]    
Short-Term Debt [Line Items]    
 Short term debt 50,050 35,050
Short term debt – Autotelic Inc. – Related Party [Member] | Other Debt [Member]    
Short-Term Debt [Line Items]    
 Short term debt 2,070,000 1,470,000
Short Term Debt from CEO – Related Party [Member] | Other Debt [Member]    
Short-Term Debt [Line Items]    
 Short term debt $ 50,000 $ 50,000
v3.24.3
SCHEDULE OF CONVERTIBLE NOTES, NET OF DISCOUNT (Details) - USD ($)
Sep. 30, 2024
Dec. 31, 2023
August 2021 [Member]    
Short-Term Debt [Line Items]    
Convertible notes, net $ 808,665 $ 782,469
August 2021 [Member] | Related Party Convertible Note, 5% Coupon December 2023 [Member]    
Short-Term Debt [Line Items]    
Convertible notes, net 289,427 280,052
August 2021 [Member] | Accredited Investors Convertible Note, 5% Coupon December 2023 [Member]    
Short-Term Debt [Line Items]    
Convertible notes, net 432,406 418,399
August 2021 [Member] | CFO Related Party Convertible Note, 5% Coupon December 2023 [Member]    
Short-Term Debt [Line Items]    
Convertible notes, net 86,832 84,018
March Two Thousand Twenty Two [Member]    
Short-Term Debt [Line Items]    
Convertible notes, net 225,296 233,393
Unamortized debt discount
March Two Thousand Twenty Two [Member] | 16% Coupon March 2023 [Member]    
Short-Term Debt [Line Items]    
Convertible notes, net 225,296 233,393
May 2022 [Member]    
Short-Term Debt [Line Items]    
Convertible notes, net 972,500 905,484
May 2022 [Member] | Mast Hill [Member]    
Short-Term Debt [Line Items]    
Blue Lake Convertible note, 16% coupon June 2023, inclusive of accrued interest and penalty 972,500 905,484
June 2023 [Member]    
Short-Term Debt [Line Items]    
Convertible notes, net  
June 2023 [Member] | Blue Lake Partners LLC [Member]    
Short-Term Debt [Line Items]    
Blue Lake Convertible note, 16% coupon June 2023, inclusive of accrued interest and penalty  
June Two Thousand And Twenty Two [Member]    
Short-Term Debt [Line Items]    
Convertible notes, net   495,800
June Two Thousand And Twenty Two [Member] | Blue Lake Partners LLC [Member]    
Short-Term Debt [Line Items]    
Blue Lake Convertible note, 16% coupon June 2023, inclusive of accrued interest and penalty   $ 495,800
v3.24.3
SCHEDULE OF SHORT-TERM LOANS (Details) - USD ($)
Sep. 30, 2024
Dec. 31, 2023
Short term advance $ 2,380,050 $ 1,765,050
Chief Financial Officer [Member]    
Short term advance 50,050 35,050
Chief Executive Officer [Member]    
Short term advance 50,000 50,000
Bridge Investor [Member]    
Short term advance 210,000 210,000
Autotelic [Member]    
Short term advance $ 2,070,000 $ 1,470,000
v3.24.3
CONVERTIBLE DEBENTURES, NOTES AND OTHER DEBT (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended 12 Months Ended
May 31, 2024
Jun. 30, 2022
Aug. 06, 2019
Apr. 01, 2019
Feb. 29, 2024
Jul. 31, 2023
Jun. 30, 2023
May 31, 2023
Jun. 30, 2022
May 31, 2022
Dec. 31, 2021
Aug. 31, 2021
Dec. 31, 2019
Nov. 30, 2019
Apr. 30, 2019
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Dec. 31, 2022
Jan. 01, 2023
Mar. 31, 2022
Jan. 31, 2022
Oct. 31, 2021
Sep. 30, 2021
Jun. 30, 2020
Short-Term Debt [Line Items]                                                      
Derivative liability                               $ 282,386   $ 282,386   $ 423,214              
Amortization of debt issuance costs and discounts                                   117,132                
Debt interest rate         125.00%                                            
Accrued interest                                   $ 1,063,300   1,031,425              
Granted total number of warrants                               10,576,924   10,576,924                  
Debt conversion amount         $ 35,000                                            
Debt converted shares         500,000                                            
Interest expense, debt, excluding amortization                               $ 8,400 $ 8,400 $ 25,500 23,000                
Additional paid in capital                               42,219,400   42,219,400   41,655,026              
Retained earnings                               (37,439,735)   (37,439,735)   (33,516,736)              
Accounts Payable                               1,692,263   1,692,263   1,656,613              
Accounting Standards Update 2020-06 [Member]                                                      
Short-Term Debt [Line Items]                                                      
Additional paid in capital                                 500,000   500,000     $ 109,349          
Unamortized debt discount                                           25,489          
Retained earnings                                 300,000   300,000     78,460          
Golden Mountain Partners LLC [Member]                                                      
Short-Term Debt [Line Items]                                                      
Interest expense                               22,700 67,500 22,700 67,500                
Accrued interest                               4,810,000   4,810,000   4,750,000              
Autotelic [Member]                                                      
Short-Term Debt [Line Items]                                                      
Accounts Payable                                       1,400,000              
Related party debt                                   2,010,000.00                  
Bridge Investor [Member]                                                      
Short-Term Debt [Line Items]                                                      
Outstanding debt amount                                   210,000   210,000              
Debt Financing [Member] | Golden Mountain Partners LLC [Member]                                                      
Short-Term Debt [Line Items]                                                      
Proceeds from lines of credit                                   1,500,000                  
Research organization developments                                   1,000,000.0                  
Fall 2019 Notes [Member]                                                      
Short-Term Debt [Line Items]                                                      
Debt unamortized principal amount                               850,000   850,000   850,000              
Convertible notes, net                               1,063,300   1,063,300   1,031,425              
GMP Note [Member]                                                      
Short-Term Debt [Line Items]                                                      
Debt interest rate                                                     2.00%
Debt financing                                                     $ 2,000,000
GMP Note 2 [Member]                                                      
Short-Term Debt [Line Items]                                                      
Debt interest rate                                                   2.00%  
Debt financing                                                   $ 1,500,000  
August 2021 Investors Notes [Member]                                                      
Short-Term Debt [Line Items]                                                      
Interest expense, debt, excluding amortization                                   26,200                  
August 2021 Investors Notes [Member] | Related Party [Member]                                                      
Short-Term Debt [Line Items]                                                      
Interest expense, debt, excluding amortization                               $ 4,060   $ 12,190                  
Securities Purchase Agreement [Member]                                                      
Short-Term Debt [Line Items]                                                      
Principal amount   $ 340,000             $ 340,000                                    
Accrued interest   531,000                                                  
Note Purchase Agreements [Member]                                                      
Short-Term Debt [Line Items]                                                      
Convertible notes, net                       $ 698,500                              
Debt instrument, description                       The convertible notes carry a five (5%) percent coupon and mature one year from issuance. The majority of the August 2021 investors have the right, but not the obligation, not more than five days following the maturity date, to convert all, but not less than all, the outstanding and unpaid principal plus accrued interest into the Company’s common stock, at a conversion price of $0.18                              
Note Purchase Agreements [Member] | Fall 2019 Notes [Member]                                                      
Short-Term Debt [Line Items]                                                      
Debt interest rate                               5.00%   5.00%                  
Interest expense                               $ 10,600   $ 32,000                  
October Purchase Agreement [Member] | Convertible Promissory Note [Member]                                                      
Short-Term Debt [Line Items]                                                      
Debt interest rate                                                 2.00%    
Amount outstanding and payable                                                 $ 500,000    
January Purchase Agreement [Member] | Convertible Promissory Note [Member]                                                      
Short-Term Debt [Line Items]                                                      
Debt interest rate                                               2.00%      
Amount outstanding and payable                                               $ 500,000      
Note Purchase Agreement [Member]                                                      
Short-Term Debt [Line Items]                                                      
Accrued interest                               110,000   110,000   84,000              
Net proceeds                       $ 691,000                              
Conversion price                       $ 0.18                              
Interest expense, debt, excluding amortization                               8,730                      
Bridge Investor [Member]                                                      
Short-Term Debt [Line Items]                                                      
Credit risk derivative liabilities, at fair value                               140,000   140,000                  
Fourth Man Convertible Note [Member]                                                      
Short-Term Debt [Line Items]                                                      
Unamortized debt discount                               0   0   0              
May 2022 [Member]                                                      
Short-Term Debt [Line Items]                                                      
Accrued interest                               198,000   198,000   131,000              
Interest expense, debt, excluding amortization                               0 0 0 146,000                
May 2022 [Member] | Convertible Debt [Member]                                                      
Short-Term Debt [Line Items]                                                      
Amount outstanding and payable                               82,000   82,000                  
May 2023 [Member] | Accounting Standards Update 2020-06 [Member]                                                      
Short-Term Debt [Line Items]                                                      
Additional paid in capital                                           200,000          
Unamortized debt discount                                           100,000          
Retained earnings                                           100,000          
May 2023 [Member] | Mast Hill Fund, LP [Member]                                                      
Short-Term Debt [Line Items]                                                      
Accrued interest                                 89,000   89,000                
June 2023 [Member]                                                      
Short-Term Debt [Line Items]                                                      
Interest expense, debt, excluding amortization                                 0                    
Interest expense, debt, excluding amortization                               8,500 $ 62,000 35,000 62,000                
June 2023 [Member] | Accounting Standards Update 2020-06 [Member]                                                      
Short-Term Debt [Line Items]                                                      
Additional paid in capital                                           200,000          
Unamortized debt discount                                           100,000          
Retained earnings                                           $ 100,000          
Bridge Investor [Member] | Convertible Debentures [Member]                                                      
Short-Term Debt [Line Items]                                                      
Derivative liability                               282,000   282,000                  
Bridge Investor [Member] | Convertible Debt [Member] | Share-Based Payment Arrangement, Tranche One [Member]                                                      
Short-Term Debt [Line Items]                                                      
Beneficial conversion feature                             $ 28,445                        
Amortization of debt issuance costs and discounts                                   0 0                
Unamortized debt discount                               0   0   0              
Bridge Investor [Member] | Convertible Debt [Member] | Share-Based Payment Arrangement, Tranche Two [Member]                                                      
Short-Term Debt [Line Items]                                                      
Beneficial conversion feature     $ 175,000                                                
Amortization of debt issuance costs and discounts                                   0 0                
Unamortized debt discount                               0   0   0              
Bridge Investor [Member] | Convertible Debt [Member] | Securities Purchase Agreement [Member]                                                      
Short-Term Debt [Line Items]                                                      
Principal amount                             400,000                        
Vyoung Trieu [Member] | Securities Purchase Agreement [Member]                                                      
Short-Term Debt [Line Items]                                                      
Unamortized debt discount                             16,444                        
Vyoung Trieu [Member] | Convertible Debt [Member]                                                      
Short-Term Debt [Line Items]                                                      
Principal amount                             250,000                        
Beneficial conversion feature       $ 131,555                                              
Amortization of debt issuance costs and discounts                                   0 $ 0                
Unamortized debt discount                               0   0   0              
Vyoung Trieu [Member] | Convertible Debt [Member] | Securities Purchase Agreement [Member]                                                      
Short-Term Debt [Line Items]                                                      
Principal amount                             $ 164,444                        
Dr. Vuong Trieu [Member] | Note Purchase Agreements [Member] | Fall 2019 Notes [Member]                                                      
Short-Term Debt [Line Items]                                                      
Principal amount                         $ 250,000 $ 250,000                          
Gross proceeds                         500,000 500,000                          
Dr. Vuong Trieu [Member] | Note Purchase Agreements [Member] | Fall 2019 Notes [Member] | Related Party [Member]                                                      
Short-Term Debt [Line Items]                                                      
Additional funding to related party                         35,000 35,000                          
Dr Sanjay Jha [Member] | Note Purchase Agreements [Member] | Fall 2019 Notes [Member]                                                      
Short-Term Debt [Line Items]                                                      
Principal amount                         250,000 250,000                          
Chulho Park [Member] | Note Purchase Agreements [Member] | Fall 2019 Notes [Member] | Related Party [Member]                                                      
Short-Term Debt [Line Items]                                                      
Additional funding to related party                         27,000 27,000                          
Amit Shah [Member] | Note Purchase Agreements [Member] | Fall 2019 Notes [Member] | Related Party [Member]                                                      
Short-Term Debt [Line Items]                                                      
Additional funding to related party                         20,000 20,000                          
Two Accredited Investors [Member] | Note Purchase Agreements [Member] | Fall 2019 Notes [Member]                                                      
Short-Term Debt [Line Items]                                                      
Principal amount                         $ 168,000 $ 168,000                          
Third Party [Member] | GMP Note [Member]                                                      
Short-Term Debt [Line Items]                                                      
Debt financing                               2,000,000   2,000,000                  
Third Party [Member] | GMP Note [Member] | Maximum [Member]                                                      
Short-Term Debt [Line Items]                                                      
Debt financing                               $ 2,000,000   $ 2,000,000                  
Five Institutional Investors [Member] | Securities Purchase Agreement [Member]                                                      
Short-Term Debt [Line Items]                                                      
Principal amount                     $ 1,250,000                                
Debt interest rate                     12.00%                       12.00%        
Conversion price                     $ 0.07                                
Debt instrument interest rate effective percentage                     16.00%                       16.00%        
Granted total number of warrants                     9,615,385                                
Common shares strike price                     $ 0.13                                
Placement Agent [Member] | Securities Purchase Agreement [Member]                                                      
Short-Term Debt [Line Items]                                                      
Conversion price                     $ 0.13                                
Granted share warrants                 83,750 302,500 961,540             125,000                  
Fourth Man LLC [Member]                                                      
Short-Term Debt [Line Items]                                                      
Debt conversion amount         $ 35,000 $ 43,000 $ 50,000 $ 50,000                                      
Debt converted shares         500,000 627,538 1,192,857 1,192,857                                      
Fourth Man LLC [Member] | Securities Purchase Agreement [Member]                                                      
Short-Term Debt [Line Items]                                                      
Principal amount                                             $ 250,000        
Conversion price                               $ 0.20   $ 0.20     $ 0.10            
Granted total number of warrants                               1,250,000   1,250,000                  
Common shares strike price                               $ 0.20   $ 0.20                  
Fourth Man Note [Member] | Securities Purchase Agreement [Member]                                                      
Short-Term Debt [Line Items]                                                      
Debt interest rate                               25.00%   25.00%                  
Estimated default penalty                               $ 70,000   $ 70,000                  
One Institutional Investors [Member] | Securities Purchase Agreement [Member]                                                      
Short-Term Debt [Line Items]                                                      
Principal amount $ 531,000 $ 335,000             $ 335,000 $ 605,000                                  
Debt interest rate   12.00%             12.00% 12.00%                                  
Conversion price   $ 0.10             $ 0.10 $ 0.10                                  
Debt instrument interest rate effective percentage   16.00%             16.00% 16.00%                                  
Granted total number of warrants   837,500             837,500 3,025,000                                  
Common shares strike price   $ 0.20             $ 0.20 $ 0.20                                  
Common shares 7,605,760                                                    
Chief Executive Officer [Member]                                                      
Short-Term Debt [Line Items]                                                      
Amount received                                   50,000   50,000              
Chief Executive Officer [Member] | Related Party [Member]                                                      
Short-Term Debt [Line Items]                                                      
Additional funding to related party                               $ 600,000   600,000                  
CFO [Member]                                                      
Short-Term Debt [Line Items]                                                      
Repayment of short term debt                                   15,000   $ 10,000 $ 25,000            
Outstanding debt amount                                   $ 50,000                  
v3.24.3
SCHEDULE OF CHANGE IN FAIR VALUE OF OUR INVESTMENT (Details) - USD ($)
9 Months Ended 12 Months Ended
Sep. 30, 2024
Dec. 31, 2023
Equity Method Investments and Joint Ventures [Abstract]    
Begining, investment $ 22,653,225 $ 22,640,521
Change in fair value of investment 12,704
Ending, investment $ 22,653,225 $ 22,653,225
v3.24.3
JOINT VENTURE WITH GMP BIO AND AFFILIATES, EQUITY METHOD INVESTMENT (Details Narrative) - USD ($)
3 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Schedule of Equity Method Investments [Line Items]          
Assets $ 26,782,245   $ 26,782,245   $ 30,014,952
Liabilities 18,650,273   18,650,273   18,403,415
Operational expenses $ 3,280,757 $ 55,522 3,544,559 $ 6,604,552  
Change in fair value of the investment       12,704
GMP Bio [Member]          
Schedule of Equity Method Investments [Line Items]          
Ownership percentage 45.00%   45.00%    
JV [Member]          
Schedule of Equity Method Investments [Line Items]          
Intangible assets net excluding goodwill $ 50,400,000   $ 50,400,000    
Assets 32,800,000   32,800,000    
Liabilities 1,000,000.0   1,000,000.0    
GMP Bio [Member]          
Schedule of Equity Method Investments [Line Items]          
Intangible assets net excluding goodwill 22,700,000   22,700,000    
Assets 8,800,000   8,800,000    
Liabilities 4,800,000   4,800,000    
Operational expenses     4,500,000 $ 4,500,000  
Change in fair value of the investment         $ 13,000
Dragon Overseas [Member]          
Schedule of Equity Method Investments [Line Items]          
Intangible assets net excluding goodwill $ 27,700,000   $ 27,700,000    
v3.24.3
SCHEDULE OF FUNDS RECEIVED UNDER THE SUBSCRIPTION AGREEMENT (Details) - Subscription Agreements [Member] - USD ($)
Sep. 30, 2024
Dec. 31, 2023
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Total PPM-2 Darbie Financing, net of discounts $ 311,693
Accredited Investors [Member]    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Total PPM-2 Darbie Financing, net of discounts 311,693
Related Party [Member]    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Total PPM-2 Darbie Financing, net of discounts
Total PPM-2 Darbie Financing, net of discounts 2,267,849 1,898,468
Accredited Investors [Member]    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Total PPM-2 Darbie Financing, net of discounts $ 2,267,849 $ 1,898,468
v3.24.3
PRIVATE PLACEMENT AND JH DARBIE FINANCING (Details Narrative) - USD ($)
1 Months Ended 7 Months Ended 9 Months Ended
Feb. 29, 2024
Feb. 28, 2022
Jan. 31, 2024
Sep. 30, 2024
Sep. 30, 2023
Mar. 31, 2021
Mar. 31, 2024
Dec. 31, 2023
Jul. 31, 2023
Number of convertible promissory note converted shares 500,000                
Number of warrants for each warrant purchased       31,890,289          
Short term debt       $ 2,380,050       $ 1,765,050  
Number of warrant issued       10,576,924          
Amortization of debt discount and debt issuance costs       $ 318,000          
Interest Expense [Member]                  
Amortization of debt discount and debt issuance costs       0 $ 8,400        
IPO [Member]                  
Issuance cost       640,000          
Legal costs       $ 39,000          
Warrant [Member]                  
Number of warrants for each warrant purchased             33,000,000    
Accredited Investors [Member] | Warrant [Member]                  
Short term debt     $ 2,350,000            
Investor [Member]                  
Number of warrants for each warrant purchased   333,334              
Warrants exercise price   $ 0.15              
Number of warrant issued   33,000,066              
Warrants to purchase common stock, description   Upon the amendment of the terms of the convertible notes under the private placement memorandum. As incentive to extend the maturity date, approximately 33 million warrants were issued to the Unit Holders who participated in the amendment. The approximately 33 million warrants to purchase shares of our Common Stock expired on March 31, 2024. The Company repaid the 1-unit holder who did not participate in the amendment shortly after March 31, 2022. Further, during the year ended December 31, 2023, the Company repaid two of the unit holders, who held 5 units and opted not to participate in the new JH Darbie financing.              
JH Darbie Placement Agreement [Member]                  
Percentage of units granted       10.00%          
Issued in transaction       10          
Interest rate           16.00%      
JH Darbie Placement Agreement [Member] | Warrant [Member]                  
Number of common stock issued     250,000            
Shares issued price per share     $ 0.12            
JH Darbie Placement Agreement [Member] | Maximum [Member]                  
Issued in transaction     200            
JH Darbie Placement Agreement [Member] | Edgepoint AI, Inc [Member]                  
Number of common stock issued           25,000      
Shares issued price per share           $ 1.00      
Conversion price           1.00      
JH Darbie Placement Agreement [Member] | Edgepoint AI, Inc [Member] | Warrant [Member]                  
Shares issued price per share           $ 0.20      
Number of warrants for each warrant purchased           50,000      
Warrants exercise price           $ 1.00      
JH Darbie Placement Agreement [Member] | Edgepoint AI, Inc [Member] | Maximum [Member]                  
Conversion price           $ 0.18      
JH Darbie Placement Agreement [Member] | Edgepoint AI, Inc [Member] | One Convertible Promissory Note [Member]                  
Number of convertible promissory note converted shares           25,000      
Conversion price           $ 1.00      
JH Darbie Placement Agreement [Member] | Edgepoint AI, Inc [Member] | One Convertible Promissory Note [Member] | Maximum [Member]                  
Number of convertible promissory note converted shares           138,889      
Conversion price           $ 0.18      
JH Darbie Placement Agreement [Member] | Accredited Investors [Member]                  
Proceeds from private placement           $ 5,000,000      
Issued in transaction     94            
JH Darbie Placement Agreement [Member] | Accredited Investors [Member] | Warrant [Member]                  
Short term debt     $ 2,350,000           $ 2,350,000
v3.24.3
SCHEDULE OF FAIR VALUE WARRANTS (Details)
Sep. 30, 2024
Fair Value Measurement Inputs and Valuation Techniques [Line Items]  
Warrant expected term 1 year 2 months 26 days
Measurement Input, Expected Term [Member]  
Fair Value Measurement Inputs and Valuation Techniques [Line Items]  
Warrant expected term 2 years
Measurement Input, Price Volatility [Member]  
Fair Value Measurement Inputs and Valuation Techniques [Line Items]  
Warrants measurement input 173
Measurement Input, Risk Free Interest Rate [Member]  
Fair Value Measurement Inputs and Valuation Techniques [Line Items]  
Warrants measurement input 4.29
Measurement Input, Expected Dividend Rate [Member]  
Fair Value Measurement Inputs and Valuation Techniques [Line Items]  
Warrants measurement input 0.00
v3.24.3
PRIVATE PLACEMENT -2 (PPM-2) AND JH DARBIE FUNDING (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended 7 Months Ended 9 Months Ended
Sep. 30, 2023
Jul. 31, 2023
Sep. 30, 2024
Mar. 31, 2024
Sep. 30, 2023
Jan. 31, 2024
Sep. 30, 2024
Sep. 30, 2023
Mar. 31, 2021
Feb. 29, 2024
Dec. 31, 2023
Short term debt     $ 2,380,050       $ 2,380,050       $ 1,765,050
Common stock, par value     $ 0.01       $ 0.01       $ 0.01
Interest rate                   125.00%  
Extinguishment of debt amount       $ (94,829)   $ (88,258) $ (94,829)      
Share based compensation arrangements, grants             3,390,000 11,300,000      
Additional paid in capital     $ 42,219,400       $ 42,219,400       $ 41,655,026
Amortization of debt discount (premium)             $ 318,000        
Accredited Investors [Member] | Warrant [Member]                      
Short term debt           $ 2,350,000          
JH Darbie Placement Agreement [Member]                      
Sale of transaction shares             10        
Interest rate                 16.00%    
Agent fees           $ 377,500          
Debt conversion description           Based on the placement agent agreement, JH Darbie was entitled to a non-refundable $25,000 fee to start the due diligence process and 2% due diligence fees and 13% commissions on all subsequent conversions or new funding. In addition, the Company provided warrant coverage equal to 13 % of all of the units sold to JH Darbie. As the Company converted an aggregate of 94 units, JH Darbie was entitled to earn a total of 3,055,000 warrants. A total of 5 unit holders under the PPM-1 opted not to participate in the PPM-2          
JH Darbie Placement Agreement [Member] | Minimum [Member]                      
Sale of transaction shares           10          
JH Darbie Placement Agreement [Member] | Maximum [Member]                      
Sale of transaction shares           200          
JH Darbie Placement Agreement [Member] | Warrant [Member]                      
Number of common stock issued           250,000          
Shares issued price per share           $ 0.12          
JH Darbie Placement Agreement [Member] | Accredited Investors [Member]                      
Sale of transaction shares           94          
Debt conversion description JH Darbie has the right to sell/convert a minimum of 10 Units and a maximum of 200 Units on a best-efforts basis JH Darbie has the right to sell/convert a minimum of 10 Units and a maximum of 200 Units on a best-efforts basis                  
JH Darbie Placement Agreement [Member] | Accredited Investors [Member] | Warrant [Member]                      
Short term debt   $ 2,350,000       $ 2,350,000          
JH Darbie Placement Agreement Two [Member]                      
Conversion price     $ 0.10       $ 0.10        
Issuance cost     $ 400,000       $ 400,000        
Stock issued during the period warrant grant             3,055,000        
Interest rate     16.00%       16.00%        
Amortization of debt discount (premium)     $ 39,800   $ 18,600   $ 117,000 $ 18,600      
JH Darbie Placement Agreement Two [Member] | Convertible Debt [Member]                      
Interest expense             $ 270,000 $ 37,000      
JH Darbie Placement Agreement Two [Member] | One Convertible Promissory Note [Member]                      
Interest rate           16.00%          
Number of common stock value           $ 25,000          
Number of common stock issued           250,000          
Common stock, par value           $ 0.01          
Conversion price           $ 0.10          
JH Darbie Placement Agreement Two [Member] | Common Stock [Member]                      
Conversion price     $ 0.026       $ 0.026        
Extinguishment of debt amount       $ 88,000              
Share based compensation arrangements, grants             3,390,000        
Additional paid in capital     $ 88,000       $ 88,000        
Share price     $ 0.12       $ 0.12        
v3.24.3
RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended 12 Months Ended
May 01, 2021
Feb. 29, 2024
Apr. 30, 2019
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2020
Dec. 31, 2023
Dec. 12, 2022
Jun. 30, 2022
Related Party Transaction [Line Items]                      
Additional short term fund   $ 35,000                  
Other short-term borrowings       $ 2,380,050   $ 2,380,050     $ 1,765,050    
Short term loan       2,380,050   2,380,050     1,765,050    
Vyoung Trieu [Member]                      
Related Party Transaction [Line Items]                      
Stock issued during period, shares, new issues               5      
Number of shares issued, value               $ 250,000      
Other short-term borrowings                 50,000    
Vyoung Trieu [Member] | Fall 2019 Note [Member]                      
Related Party Transaction [Line Items]                      
Additional short term fund     $ 35,000                
Vyoung Trieu [Member] | Convertible Debt [Member]                      
Related Party Transaction [Line Items]                      
Debt instrument, face amount     250,000                
Debt instrument, unamortized discount       0   0     0    
Proceeds from convertible debt     148,000                
Autotelic Inc [Member]                      
Related Party Transaction [Line Items]                      
Short term loan       600,000   600,000     $ 1,400,000    
Autotelic Inc [Member] | August 2021 Note [Member]                      
Related Party Transaction [Line Items]                      
Additional short term fund $ 250,000                    
Short term loan       2,010,000.00   2,010,000.00       $ 120,000  
Master Service Agreement [Member] | Autotelic Inc [Member] | Related Party [Member]                      
Related Party Transaction [Line Items]                      
Related party expenses       $ 500 $ 500 $ 1,500 $ 11,000        
Securities Purchase Agreement [Member]                      
Related Party Transaction [Line Items]                      
Debt instrument, face amount                     $ 340,000
Stock issued during period, shares, new issues           7.6          
Securities Purchase Agreement [Member] | Vyoung Trieu [Member]                      
Related Party Transaction [Line Items]                      
Debt instrument, unamortized discount     16,444                
Securities Purchase Agreement [Member] | Vyoung Trieu [Member] | Convertible Debt [Member]                      
Related Party Transaction [Line Items]                      
Debt instrument, face amount     $ 164,444                
Artius Consulting Agreement [Member] | Related Party [Member]                      
Related Party Transaction [Line Items]                      
Related party expenses           $ 0 0        
Maida Consulting Agreement [Member] | Related Party [Member] | Dr. Maida [Member]                      
Related Party Transaction [Line Items]                      
Related party expenses           $ 0 $ 0        
v3.24.3
STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($)
1 Months Ended
May 31, 2024
Feb. 29, 2024
Jul. 31, 2023
Jun. 30, 2023
May 31, 2023
Feb. 28, 2023
Conversion fee, values   $ 35,000        
Conversion fee, shares   500,000        
Blue Lake [Member]            
Conversion fee, values $ 531,000     $ 181,750   $ 71,750
Conversion fee, shares 7,605,760     3,466,853   1,025,000
Fourth Man LLC [Member]            
Conversion fee, values   $ 35,000 $ 43,000 $ 50,000 $ 50,000  
Conversion fee, shares   500,000 627,538 1,192,857 1,192,857  
Debt conversion amount       $ 30,000 $ 30,000  
v3.24.3
SCHEDULE OF COMPENSATION BASED STOCK OPTION ACTIVITY (Details) - $ / shares
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Share-Based Payment Arrangement [Abstract]    
Options outstanding, Balance 24,177,761 25,690,261
Weighted average exercise price outstanding, Balance $ 0.21 $ 0.23
Options outstanding, Expired or Cancelled (1,512,500)
Weighted average exercise price outstanding, Expired or Cancelled $ 0.46
Options outstanding, Balance 24,177,761 24,177,761
Weighted average exercise price outstanding, Balance $ 0.21 $ 0.21
Options exercisable, Balance 13,985,261  
Weighted average exercise price outstanding, Exercisable $ 0.10  
v3.24.3
SCHEDULE OF OPTIONS TO PURCHASE SHARES OF COMMON STOCK OUTSTANDING AND EXERCISABLE (Details)
9 Months Ended
Sep. 30, 2024
$ / shares
shares
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]  
Number of Outstanding Options | shares 24,177,761
Weighted Average Remaining Life In Years 6 years 9 months 18 days
Weighted-Average Exercise Price $ 0.21
Number Exercisable | shares 13,985,261
Exercise Price 1 [Member]  
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]  
Exercise prices, Lower limit $ 0.1
Exercise prices, Upper limit $ 0.15
Number of Outstanding Options | shares 16,250,000
Weighted Average Remaining Life In Years 7 years 6 months
Weighted-Average Exercise Price $ 0.12
Number Exercisable | shares 6,057,500
Exercise Price 2 [Member]  
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]  
Exercise prices, Lower limit $ 0.16
Exercise prices, Upper limit $ 0.21
Number of Outstanding Options | shares 5,502,761
Weighted Average Remaining Life In Years 6 years 9 months 18 days
Weighted-Average Exercise Price $ 0.16
Number Exercisable | shares 5,502,761
Exercise Price 3 [Member]  
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]  
Exercise prices, Lower limit $ 0.22
Exercise prices, Upper limit $ 0.37
Number of Outstanding Options | shares 1,550,000
Weighted Average Remaining Life In Years 3 years 3 months 18 days
Weighted-Average Exercise Price $ 0.28
Number Exercisable | shares 1,550,000
Exercise Price 4 [Member]  
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]  
Exercise prices, Lower limit $ 0.38
Exercise prices, Upper limit $ 0.72
Number of Outstanding Options | shares 500,000
Weighted Average Remaining Life In Years 1 year 6 months
Weighted-Average Exercise Price $ 0.72
Number Exercisable | shares 500,000
Exercise Price 5 [Member]  
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]  
Exercise prices, Lower limit $ 0.73
Exercise prices, Upper limit $ 15.0
Number of Outstanding Options | shares 375,000
Weighted Average Remaining Life In Years 8 months 12 days
Weighted-Average Exercise Price $ 4.14
Number Exercisable | shares 375,000
v3.24.3
SCHEDULE OF WARRANTS ACTIVITY (Details) - $ / shares
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Share-Based Payment Arrangement [Abstract]    
Number of Stock Options Outstanding, Balance 61,500,355 81,072,855
Weighted-Average Exercise Price, Outstanding, Balance $ 0.15 $ 0.18
Number of Stock Options, Issued 3,390,000 11,300,000
Weighted-Average Exercise Price, Issued $ 0.12 $ 0.12
Number of Stock Options, Expired / cancelled (33,000,066) (42,737,500)
Weighted-Average Exercise Price, Expired / cancelled $ 0.15 $ 0.20
Number of Stock Options Outstanding, Balance 31,890,289 49,635,355
Weighted-average exercise price, outstanding, Balance $ 0.13 $ 0.15
v3.24.3
SCHEDULE OF WARRANTS OUTSTANDING AND EXERCISABLE (Details) - $ / shares
Sep. 30, 2024
Mar. 31, 2024
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]    
Warrants Outstanding, Number of Warrants 31,890,289  
Weighted Average Remaining Life in Years 1 year 2 months 26 days  
Warrants Weighted Average Exercise Price $ 0.13  
Warrants Outstanding, Number of Exercisable 31,890,289  
Warrant [Member]    
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]    
Warrants Outstanding, Number of Exercisable   33,000,000
Exercise Price 1 [Member] | Warrant [Member]    
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]    
Warrants Outstanding, Exercise Price $ 0.13  
Warrants Outstanding, Number of Warrants 961,539  
Weighted Average Remaining Life in Years 2 years 1 month 24 days  
Warrants Weighted Average Exercise Price $ 0.13  
Warrants Outstanding, Number of Exercisable 961,539  
Exercise Price 2 [Member] | Warrant [Member]    
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]    
Warrants Outstanding, Exercise Price $ 0.20  
Warrants Outstanding, Number of Warrants 4,373,750  
Warrants Weighted Average Exercise Price $ 0.20  
Warrants Outstanding, Number of Exercisable 4,373,750  
Exercise Price 2 [Member] | Warrant [Member] | Minimum [Member]    
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]    
Weighted Average Remaining Life in Years 2 years 5 months 26 days  
Exercise Price 2 [Member] | Warrant [Member] | Maximum [Member]    
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]    
Weighted Average Remaining Life in Years 2 years 8 months 23 days  
Exercise Price 3 [Member] | Warrant [Member]    
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]    
Warrants Outstanding, Exercise Price $ 0.12  
Warrants Outstanding, Number of Warrants 26,555,000  
Warrants Weighted Average Exercise Price $ 0.12  
Warrants Outstanding, Number of Exercisable 26,555,000  
Exercise Price 3 [Member] | Warrant [Member] | Minimum [Member]    
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]    
Weighted Average Remaining Life in Years 9 months 7 days  
Exercise Price 3 [Member] | Warrant [Member] | Maximum [Member]    
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]    
Weighted Average Remaining Life in Years 1 year 3 months 29 days  
v3.24.3
STOCK-BASED COMPENSATION (Details Narrative) - USD ($)
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Options exercisable period 10 years  
Vesting period 3 years  
Unamortized stock compensation $ 0  
Stock options description Of the approximately 14 million unvested stock options, the vesting criteria for 7.3 million options is still being evaluated as on the date of this Report, as those options are subject to individual milestone achievements  
Share based compensation $ 0 $ 0
Warrants issued to purchase shares 10,576,924  
Warrant rights outstanding $ 1,172,753  
2017 Equity Incentive Plan [Member] | Maximum [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of common stock issued to awards 2,000,000  
2015 and 2005 Equity Incentive Plan [Member] | Maximum [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of common stock issued to awards 27,250,000  
v3.24.3
INCOME TAXES (Details Narrative)
9 Months Ended
Sep. 30, 2024
Income Tax Disclosure [Abstract]  
Operating loss carry forwards Portions of these carryforwards will expire through 2038, if not otherwise utilized
v3.24.3
COMMITMENTS AND CONTINGENCIES (Details Narrative)
9 Months Ended
Sep. 30, 2024
USD ($)
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]  
Non payment of amount $ 20,000
Merger Agreement [Member] | Point R Merger [Member]  
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]  
Payments to acquire businesses, gross 17,831,427
Business combination, contingent consideration, liability 2,625,000
Business combination, consideration transferred, equity interests issued and issuable $ 15,000,000

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