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UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13
or 15(d)
of the Securities Exchange
Act of 1934
Date of Report (Date
of earliest event reported): August 9, 2023
CYCLACEL
PHARMACEUTICALS, INC.
(Exact name of registrant
as specified in its charter)
Delaware |
|
0-50626 |
|
91-1707622 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
200
Connell Drive, Suite 1500
Berkeley
Heights, NJ 07922
(Address of principal
executive offices and zip code)
Registrant’s telephone
number, including area code: (908) 517-7330
(Former Name or Former
Address, if Changed Since Last Report)
Check the appropriate
box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
| ¨ | Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered
|
Common
Stock, par value $0.001 per share |
CYCC |
The Nasdaq
Capital Market LLC |
Preferred
Stock, $0.001 par value |
CYCCP |
The Nasdaq
Capital Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ¨
Item 2.02 |
Results of Operations and Financial Condition. |
The information set forth
under this “Item 2.02. Results of Operations and Financial Condition,” including the exhibit attached hereto, shall not be
deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated
by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference
in such filing.
Attached as Exhibit 99.1 is
a copy of a press release of Cyclacel Pharmaceuticals, Inc. (the “Company”), dated August 9, 2023, announcing certain
financial results for the second quarter ended June 30, 2023.
The Company will conduct a
conference call to review its financial results on August 9, 2023, at 4:30 p.m., Eastern Time.
Item 9.01 |
Financial Statements and Exhibits. |
SIGNATURES
Pursuant to the requirements
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.
CYCLACEL PHARMACEUTICALS, INC. |
|
|
|
|
By: |
/s/ Paul McBarron |
|
Name: |
Paul McBarron |
|
Title: |
Executive Vice President-Finance, |
|
|
Chief Financial Officer and Chief Operating Officer |
|
Date: August 9, 2023
Exhibit 99.1
|
Cyclacel Pharmaceuticals, Inc. |
Cyclacel
Pharmaceuticals Reports SECOND quarter financial results
and
provides business update
-
Key Catalysts ahead with Multiple Value Generating Readouts-
-
Expects to Release Phase 1/2 Data with Oral Fadraciclib -
-
Signals of Single-agent Efficacy with Oral Plogosertib -
- Management to Host Conference Call at 4:30
pm EDT Today-
BERKELEY HEIGHTS, NJ, August 9, 2023 - Cyclacel Pharmaceuticals, Inc.
(NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical leader in cell cycle checkpoint control
developing innovative medicines based on cancer cell biology, announced today second quarter financial results and provided a business
update.
“Both clinical programs with fadraciclib and plogosertib are
progressing well, and we are on track to report on important readouts this year,” said Spiro Rombotis, President and Chief Executive
Officer. “Based on data collected to date we believe that fadraciclib’s
next generation CDK inhibitor profile is differentiated from other molecules in its class. Similarly plogosertib could emerge as a PLK1
inhibitor with novel epigenetic activity. We look forward to presenting data from these two programs in the coming months.”
“We are completing dose escalation level 6A with six patients
in the 065-101 study of fadraciclib as a single agent and expect to select the recommended Phase 2 dosing schedule shortly. A patient
with endometrial cancer in dose level 6A has documented tumor shrinkage after one cycle,” said Mark Kirschbaum, M.D., Chief Medical
Officer. “In the 140-101 study of plogosertib as a single agent we are recruiting patients at dose level 5. Anticancer activity
has been observed thus far in four out of twelve patients, with adenoid cystic carcinoma, biliary, non-small cell lung, and ovarian cancer
respectively, who stayed on treatment for three to eight cycles. The activity at low level, continuous exposure may be due to the effects
of plogosertib operating through a novel epigenetic mechanism which we are continuing to investigate. If confirmed, we will design clinical
studies that could exploit these findings.“
Key Upcoming Milestones
| • | Report final data from dose escalation stage and RP2D determination from the 065-101 study of oral fadraciclib in patients with advanced
solid tumors and lymphoma |
| • | First patient dosed with oral fadraciclib in Phase 2 proof-of-concept stage of 065-101 study in patients with advanced solid tumors
and lymphoma |
| • | Report Phase 1 data from 140-101 study of oral plogosertib in patients with advanced solid tumors and lymphoma |
| • | Elaborate novel mechanism of action of plogosertib |
Financial Highlights
As
of June 30, 2023, cash equivalents totaled $10.2 million, compared to $18.3 million as of December 31, 2022. Net cash used in
operating activities was $8.2 million for the six months ended June 30, 2023 compared to $8.7 million for the same period of 2022.
The Company estimates that its available cash will fund currently planned programs through the end
of 2023. The operating plan includes discretionary expenditures, which if not incurred could extend liquidity requirements into
the second quarter of 2024.
Research and development (R&D) expenses
were $4.7 million for the three months ended June 30, 2023, as compared to $4.2 million for the same period in 2022. R&D expenses
relating to fadraciclib were $3.0 million for the three months ended June 30, 2023, as compared to $2.6 million for the same period
in 2022 due to increased non-clinical expenditures. R&D expenses related to plogosertib were $1.4 million for the three months ended
June 30, 2023, as compared to $1.5 million for the same period in 2022 due to clinical trial costs associated with the progression
of the Phase 1/2 study.
General and administrative expenses for the
three months ended June 30, 2023 and 2022, remained relatively flat at $1.6 million.
Total other expense, net, for the three months
ended June 30, 2023, was $0.1 million compared to an income of $0.2 million for the same period of the previous year.
United Kingdom research & development
tax credits for the three months ended June 30, 2023 were $0.6 million compared to $1.0 million for the same period of the previous
year due to taxation legislative changes that took effect in April 2023. Research & development tax credits are directly
correlated to qualifying research and development expenditure.
Net loss for the three months ended June 30,
2023, was $5.4 million, compared to $4.6 million for the same period in 2022.
Conference call information:
Call: (800) 225-9448 / international call:
(203) 518-9708
Archive: (800) 839-6136 / international archive:
(402) 220-2572
Code for live and archived conference call
is CYCCQ223. Webcast link
For the live and archived webcast, please
visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for
90 days and the audio replay for 7 days.
About Cyclacel Pharmaceuticals, Inc.
Cyclacel is a clinical-stage, biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional
regulation, epigenetics and mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, and
the epigenetic/anti-mitotic program plogosertib, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies. Cyclacel's strategy
is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology
indications. For additional information, please visit www.cyclacel.com.
Forward-looking Statements
This news release contains certain forward-looking
statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or
from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding,
among other things, the efficacy, safety and intended utilization of Cyclacel’s product candidates, the conduct and results of
future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities.
Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early
research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty
enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside
financing to meet capital requirements, the potential effects of the COVID-19 pandemic, and the risks associated with reliance on collaborative
partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that
include the words "may," "will," "would," "could," "should," "believes,"
"estimates," "projects," "potential," "expects," "plans," "anticipates,"
"intends," "continues," "forecast," "designed," "goal," or the negative of those words
or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the
Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the Securities
and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they
are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events
or otherwise.
Contacts
Company: |
Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com |
Investor Relations: |
Grace Kim, IR@cyclacel.com |
© Copyright 2023 Cyclacel Pharmaceuticals, Inc. All Rights
Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.
SOURCE: Cyclacel Pharmaceuticals, Inc.
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS)
(In $000s, except share and per share amounts)
| |
Three Months Ended | |
| |
June 30, | |
| |
2023 | | |
2022 | |
Revenues | |
$ | 373 | | |
$ | - | |
| |
| | | |
| | |
Operating expenses: | |
| | | |
| | |
Research and development | |
| 4,727 | | |
| 4,205 | |
General and administrative | |
| 1,575 | | |
| 1,580 | |
Total operating expenses | |
| 6,302 | | |
| 5,785 | |
Operating loss | |
| (5,929 | ) | |
| (5,785 | ) |
Other income (expense): | |
| | | |
| | |
Foreign exchange gains (losses) | |
| (76 | ) | |
| 209 | |
Interest income | |
| 77 | | |
| 17 | |
Other income, net | |
| (106 | ) | |
| - | |
Total other income (expense), net | |
| (105 | ) | |
| 226 | |
Loss before taxes | |
| (6,034 | ) | |
| (5,559 | ) |
Income tax benefit | |
| 586 | | |
| 984 | |
Net loss | |
| (5,448 | ) | |
| (4,575 | ) |
Dividend on convertible exchangeable preferred shares | |
| (50 | ) | |
| (50 | ) |
Net loss applicable to common shareholders | |
$ | (5,498 | ) | |
$ | (4,625 | ) |
Basic and diluted earnings per common share: | |
| | | |
| | |
Net loss per share – basic and diluted | |
$ | (0.44 | ) | |
$ | (0.46 | ) |
Weighted average common shares outstanding | |
| 12,551,794 | | |
| 10,136,089 | |
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEET
(In $000s, except share, per share, and liquidation
preference amounts)
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 10,164 | | |
$ | 18,345 | |
Prepaid expenses and other current assets | |
| 5,130 | | |
| 6,066 | |
Total current assets | |
| 15,294 | | |
| 24,411 | |
| |
| | | |
| | |
Property and equipment, net | |
| 24 | | |
| 32 | |
Right-of-use lease asset | |
| 124 | | |
| 142 | |
Non-current deposits | |
| 1,000 | | |
| 2,916 | |
Total assets | |
$ | 16,442 | | |
$ | 27,501 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 2,169 | | |
$ | 2,561 | |
Accrued and other current liabilities | |
| 4,577 | | |
| 4,831 | |
Total current liabilities | |
| 6,746 | | |
| 7,392 | |
Lease liability | |
| 66 | | |
| 106 | |
Total liabilities | |
| 6,812 | | |
| 7,498 | |
| |
| | | |
| | |
Redeemable common stock | |
| 4,494 | | |
| 4,494 | |
| |
| | | |
| | |
Stockholders’ equity | |
| 5,136 | | |
| 15,509 | |
Total liabilities and stockholders’ equity | |
$ | 16,442 | | |
$ | 27,501 | |
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