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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒ |
QUARTERLY REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the Quarterly Period Ended September 30, 2023
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: 001-36019
TONIX
PHARMACEUTICALS HOLDING CORP.
(Exact
name of registrant as specified in its charter)
Nevada |
|
26-1434750 |
(State or other jurisdiction
of incorporation or organization) |
|
(I.R.S. Employer
Identification No.) |
|
|
|
26 Main Street,
Suite 101 |
|
|
Chatham,
New Jersey |
|
07928 |
(Address of Principal
Executive Offices) |
|
(Zip Code) |
|
|
|
(862)
799-9155
(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 each exchange on which registered |
Common
Stock |
TNXP |
The
NASDAQ Global Market |
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, smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated
filer,” “smaller reporting company” and “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 9, 2023, there were 23,849,341 shares of registrant’s common stock outstanding.
TONIX
PHARMACEUTICALS HOLDING CORP.
INDEX
PART
I – FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Par Value and Share Amounts)
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
(unaudited) | | |
| | |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 6,914 | | |
$ | 120,229 | |
Inventory | |
| 13,317 | | |
| — | |
Receivables, net | |
| 1,562 | | |
| — | |
Prepaid expenses and other | |
| 9,544 | | |
| 10,548 | |
Total current assets | |
| 31,337 | | |
| 130,777 | |
| |
| | | |
| | |
Property and equipment, net | |
| 94,866 | | |
| 93,814 | |
| |
| | | |
| | |
Intangible assets, net | |
| 9,982 | | |
| 120 | |
Goodwill | |
| 965 | | |
| — | |
Operating lease right-to-use assets | |
| 1,081 | | |
| 715 | |
Other non-current assets | |
| 1,051 | | |
| 264 | |
| |
| | | |
| | |
Total assets | |
$ | 139,282 | | |
$ | 225,690 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 7,799 | | |
$ | 8,068 | |
Accrued expenses and other current liabilities | |
| 9,500 | | |
| 9,680 | |
Lease liability, short term | |
| 434 | | |
| 432 | |
Total current liabilities | |
| 17,733 | | |
| 18,180 | |
| |
| | | |
| | |
Lease liability, long term | |
| 716 | | |
| 328 | |
| |
| | | |
| | |
Total liabilities | |
| 18,449 | | |
| 18,508 | |
| |
| | | |
| | |
Commitments (See Note 19) | |
| | | |
| | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
| |
| | | |
| | |
Preferred stock, $0.001 par value; 5,000,000 shares authorized | |
| | | |
| | |
Series B Convertible Preferred stock, 0 shares designated as of both September 30, 2023 and December 31, 2022; issued and outstanding - none | |
| — | | |
| — | |
Series A Convertible Preferred stock, 0 shares designated as of both September 30, 2023 and December 31, 2022; issued and outstanding - none | |
| — | | |
| — | |
| |
| | | |
| | |
Common stock, $0.001 par value; 160,000,000 shares authorized; 17,762,341 and 12,368,620 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively and 14,999 shares to be issued as of December 31, 2022 | |
| 18 | | |
| 12 | |
Additional paid in capital | |
| 694,371 | | |
| 677,375 | |
Accumulated deficit | |
| (573,336 | ) | |
| (470,038 | ) |
Accumulated other comprehensive loss | |
| (220 | ) | |
| (167 | ) |
| |
| | | |
| | |
Total stockholders’ equity | |
| 120,833 | | |
| 207,182 | |
| |
| | | |
| | |
Total liabilities and stockholders’ equity | |
$ | 139,282 | | |
$ | 225,690 | |
See
the accompanying notes to the condensed consolidated financial statements
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(In Thousands, Except Share and Per Share Amounts)
(unaudited)
| |
| | |
| | |
| | |
| |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
REVENUE: | |
| | |
| | |
| | |
| |
Product revenue, net | |
$ | 3,989 | | |
$ | — | | |
$ | 3,989 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
COSTS AND EXPENSES: | |
| | | |
| | | |
| | | |
| | |
Cost of revenue | |
$ | 2,374 | | |
$ | — | | |
$ | 2,374 | | |
$ | — | |
Research and development | |
| 21,050 | | |
| 22,201 | | |
| 69,535 | | |
| 57,202 | |
Selling, general and administrative | |
| 8,712 | | |
| 7,390 | | |
| 23,131 | | |
| 22,161 | |
Costs and Expenses | |
| 32,136 | | |
| 29,591 | | |
| 95,040 | | |
| 79,363 | |
| |
| | | |
| | | |
| | | |
| | |
Operating loss | |
| (28,147 | ) | |
| (29,591 | ) | |
| (91,051 | ) | |
| (79,363 | ) |
| |
| | | |
| | | |
| | | |
| | |
Interest income, net | |
| 172 | | |
| 610 | | |
| 1,715 | | |
| 825 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
| (27,975 | ) | |
| (28,981 | ) | |
| (89,336 | ) | |
| (78,538 | ) |
| |
| | | |
| | | |
| | | |
| | |
Preferred stock deemed dividend | |
| — | | |
| — | | |
| — | | |
| 4,255 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss available to common stockholders | |
$ | (27,975 | ) | |
$ | (28,981 | ) | |
$ | (89,336 | ) | |
$ | (82,793 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share, basic and diluted | |
$ | (1.83 | ) | |
$ | (4.24 | ) | |
$ | (7.40 | ) | |
$ | (18.58 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding, basic and diluted | |
| 15,327,558 | | |
| 6,843,099 | | |
| 12,079,583 | | |
| 4,455,943 | |
See
the accompanying notes to the condensed consolidated financial statements
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS
(In Thousands)
(unaudited)
| |
| | |
| | |
| | |
| |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net loss | |
$ | (27,975 | ) | |
$ | (28,981 | ) | |
$ | (89,336 | ) | |
$ | (78,538 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive loss: | |
| | | |
| | | |
| | | |
| | |
Foreign currency translation loss | |
| (8 | ) | |
| (17 | ) | |
| (53 | ) | |
| (68 | ) |
| |
| | | |
| | | |
| | | |
| | |
Comprehensive loss | |
$ | (27,983 | ) | |
$ | (28,998 | ) | |
$ | (89,389 | ) | |
$ | (78,606 | ) |
See
the accompanying notes to the condensed consolidated financial statements
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
NINE
MONTHS ENDED SEPTEMBER 30, 2023
(In
Thousands, Except Share and Per Share Amounts)
(unaudited)
| |
| | |
| | |
| | |
Accumulated | | |
| | |
| |
| |
| | |
| | |
Additional | | |
Other | | |
| | |
| |
| |
Common stock | | |
Paid in | | |
Comprehensive | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Capital | | |
Gain (loss) | | |
Deficit | | |
Total | |
Balance, December 31, 2022 | |
| 12,368,620 | | |
$ | 12 | | |
$ | 677,375 | | |
$ | (167 | ) | |
$ | (470,038 | ) | |
$ | 207,182 | |
Repurchase of common stock under Share Repurchase Program | |
| (2,672,044 | ) | |
| (3 | ) | |
| — | | |
| — | | |
| (13,962 | ) | |
| (13,965 | ) |
Issuance of common stock under 2022 Purchase agreement | |
| 96,000 | | |
| — | | |
| 441 | | |
| — | | |
| — | | |
| 441 | |
Issuance of common stock under At-the-market offering, net of transactional expenses of $101 | |
| 514,502 | | |
| 1 | | |
| 1,994 | | |
| — | | |
| — | | |
| 1,995 | |
Employee stock purchase plan | |
| 14,999 | | |
| — | | |
| 29 | | |
| — | | |
| — | | |
| 29 | |
Stock-based compensation | |
| — | | |
| — | | |
| 2,794 | | |
| — | | |
| — | | |
| 2,794 | |
Foreign currency transaction gain | |
| — | | |
| — | | |
| — | | |
| (44 | ) | |
| — | | |
| (44 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| (33,005 | ) | |
| (33,005 | ) |
Balance, March 31, 2023 | |
| 10,322,077 | | |
$ | 10 | | |
$ | 682,633 | | |
$ | (211 | ) | |
$ | (517,005 | ) | |
$ | 165,427 | |
Issuance of common stock under At-the-market offering, net of transactional expenses of $36 | |
| 440,264 | | |
| 1 | | |
| 1,028 | | |
| — | | |
| — | | |
| 1,029 | |
Stock-based compensation | |
| — | | |
| — | | |
| 2,364 | | |
| — | | |
| — | | |
| 2,364 | |
Foreign currency transaction gain | |
| — | | |
| — | | |
| — | | |
| (1 | ) | |
| — | | |
| (1 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| (28,356 | ) | |
| (28,356 | ) |
Balance, June 30, 2023 | |
| 10,762,341 | | |
$ | 11 | | |
$ | 686,025 | | |
$ | (212 | ) | |
$ | (545,361 | ) | |
$ | 140,463 | |
Issuance of common stock under AGP Financing, net of transactional expenses of $726 | |
| 2,530,000 | | |
| 3 | | |
| 6,271 | | |
| — | | |
| — | | |
| 6,274 | |
Issuance of common stock upon exercise of prefunded warrants under AGP Financing | |
| 4,470,000 | | |
| 4 | | |
| (4 | ) | |
| — | | |
| — | | |
| — | |
Stock-based compensation | |
| — | | |
| — | | |
| 2,079 | | |
| — | | |
| — | | |
| 2,079 | |
Foreign currency transaction gain | |
| — | | |
| — | | |
| — | | |
| (8 | ) | |
| — | | |
| (8 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| (27,975 | ) | |
| (27,975 | ) |
Balance, September 30, 2023 | |
| 17,762,341 | | |
$ | 18 | | |
$ | 694,371 | | |
$ | (220 | ) | |
$ | (573,336 | ) | |
$ | 120,833 | |
See
the accompanying notes to the condensed consolidated financial statements
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
NINE
MONTHS ENDED SEPTEMBER 30, 2022
(In
Thousands, Except Share and Per Share Amounts)
(unaudited)
| |
| | |
| | |
| | |
Accumulated | | |
| | |
| |
| |
| | |
| | |
Additional | | |
Other | | |
| | |
| |
| |
Common stock | | |
Paid in | | |
Comprehensive | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Capital | | |
Gain (loss) | | |
Deficit | | |
Total | |
Balance, December 31, 2021 | |
| 2,634,110 | | |
$ | 3 | | |
$ | 578,626 | | |
$ | (92 | ) | |
$ | (359,820 | ) | |
$ | 218,717 | |
Issuance of common stock in January and March 2022 under At-the-market offering, net of transactional expenses of $507 | |
| 172,276 | | |
| — | | |
| 8,488 | | |
| — | | |
| — | | |
| 8,488 | |
Issuance of common stock under 2021 Purchase agreement | |
| 110,000 | | |
| — | | |
| 4,535 | | |
| — | | |
| — | | |
| 4,535 | |
Employee stock purchase plan | |
| 646 | | |
| — | | |
| 40 | | |
| — | | |
| — | | |
| 40 | |
Stock-based compensation | |
| — | | |
| — | | |
| 2,620 | | |
| — | | |
| — | | |
| 2,620 | |
Foreign currency transaction gain | |
| — | | |
| — | | |
| — | | |
| (26 | ) | |
| — | | |
| (26 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| (26,417 | ) | |
| (26,417 | ) |
Balance, March 31, 2022 | |
| 2,917,032 | | |
| 3 | | |
| 594,309 | | |
| (118 | ) | |
| (386,237 | ) | |
| 207,957 | |
Issuance of common stock in April, May and June 2022 under At-the-market offering, net of transaction expenses of $1,426 | |
| 2,220,699 | | |
| 2 | | |
| 42,966 | | |
| — | | |
| — | | |
| 42,968 | |
Issuance of common stock under 2021 Purchase agreement | |
| 65,000 | | |
| — | | |
| 1,964 | | |
| — | | |
| — | | |
| 1,964 | |
Preferred stock dividend | |
| — | | |
| — | | |
| (4,255 | ) | |
| — | | |
| — | | |
| (4,255 | ) |
Stock-based compensation | |
| — | | |
| — | | |
| 2,813 | | |
| — | | |
| — | | |
| 2,813 | |
Foreign currency transaction gain | |
| — | | |
| — | | |
| — | | |
| (25 | ) | |
| — | | |
| (25 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| (23,140 | ) | |
| (23,140 | ) |
Balance, June 30, 2022 | |
| 5,202,731 | | |
| 5 | | |
| 637,797 | | |
| (143 | ) | |
| (409,377 | ) | |
| 228,282 | |
Issuance of common stock in July, August and September 2022 under At-the-market offering, net of transactional expenses of $805 | |
| 3,079,176 | | |
| 3 | | |
| 24,689 | | |
| — | | |
| — | | |
| 24,692 | |
Issuance of common stock under the 2021 Purchase agreement | |
| 281,557 | | |
| 1 | | |
| 2,182 | | |
| — | | |
| — | | |
| 2,183 | |
Issuance of commitment shares under 2022 Purchase Agreement | |
| 100,000 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
Stock-based compensation | |
| — | | |
| — | | |
| 2,765 | | |
| — | | |
| — | | |
| 2,765 | |
Foreign currency transaction gain | |
| — | | |
| — | | |
| — | | |
| (17 | ) | |
| — | | |
| (17 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| (28,981 | ) | |
| (28,981 | ) |
Balance, September 30, 2022 | |
| 8,663,464 | | |
$ | 9 | | |
$ | 667,433 | | |
$ | (160 | ) | |
$ | (438,358 | ) | |
$ | 228,924 | |
See
the accompanying notes to the condensed consolidated financial statements
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
Thousands)
(unaudited)
| |
| | |
| |
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | | |
| | |
Net loss | |
$ | (89,336 | ) | |
$ | (78,538 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 3,030 | | |
| 417 | |
Gain on disposal of property and equipment | |
| (196 | ) | |
| — | |
Stock-based compensation | |
| 7,237 | | |
| 8,198 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Receivables, net | |
| (1,562 | ) | |
| — | |
Prepaid expenses and other | |
| 3,334 | | |
| (753 | ) |
Accounts payable | |
| 446 | | |
| (4,079 | ) |
Operating lease liabilities and ROU asset, net | |
| 24 | | |
| 5 | |
Accrued expenses and other current liabilities | |
| (2,640 | ) | |
| (1,002 | ) |
Net cash used in operating activities | |
| (79,663 | ) | |
| (75,752 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |
| | | |
| | |
Purchase of a business | |
| (22,174 | ) | |
| — | |
Disposal of property and equipment | |
| 992 | | |
| — | |
Purchase of property and equipment | |
| (7,457 | ) | |
| (43,476 | ) |
Net cash used in investing activities | |
| (28,639 | ) | |
| (43,476 | ) |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Proceeds from ESPP | |
| 29 | | |
| 40 | |
Proceeds, net of $0 and $4,255 expenses, from sale of convertible redeemable preferred stock | |
| — | | |
| 27,245 | |
Redemption of convertible redeemable preferred stock | |
| — | | |
| (31,500 | ) |
Repurchase of common stock | |
| (13,965 | ) | |
| — | |
Proceeds, net of $863 and $2,738 expenses, from sale of common stock | |
| 9,739 | | |
| 84,830 | |
Net cash (used in) provided by financing activities | |
| (4,197 | ) | |
| 80,615 | |
| |
| | | |
| | |
Effect of currency rate change on cash | |
| (55 | ) | |
| (69 | ) |
| |
| | | |
| | |
Net decrease in cash, cash equivalents and restricted cash | |
| (112,554 | ) | |
| (38,682 | ) |
Cash, cash equivalents and restricted cash beginning of the period | |
| 120,470 | | |
| 178,900 | |
| |
| | | |
| | |
Cash, cash equivalents and restricted cash end of period | |
$ | 7,916 | | |
$ | 140,218 | |
| |
| | | |
| | |
Supplemental disclosures of cash flow information: | |
| | | |
| | |
Non-cash financing and investing activities: | |
| | | |
| | |
Purchases of property and equipment included in accounts payable and accrued liabilities | |
$ | 275 | | |
$ | (3,310 | ) |
Preferred stock deemed dividend | |
$ | — | | |
$ | 4,255 | |
See
the accompanying notes to the condensed consolidated financial statements
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
SEPTEMBER
30, 2023 AND 2022 (UNAUDITED)
NOTE 1 – BUSINESS
Tonix Pharmaceuticals
Holding Corp., through its wholly owned subsidiary Tonix Pharmaceuticals, Inc. (“Tonix Sub”), is a biopharmaceutical
company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate
suffering. The therapeutics under development include both small molecules and biologics. Tonix, through its recent acquisition,
markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace®
SymTouch® and Tosymra®, which were acquired as of June 30, 2023 (See Note 10), are each indicated for the treatment of
acute migraine with or without aura in adults. All other drug product and vaccine candidates are still in development, and are
not approved or marketed.
The condensed consolidated
financial statements include the accounts of Tonix Pharmaceuticals Holding Corp. and its wholly owned subsidiaries, Tonix Sub,
Krele LLC, Tonix Pharmaceuticals (Canada), Inc., Tonix Medicines, Inc., Jenner LLC, Tonix R&D Center LLC, Tonix Pharma Holdings
Limited and Tonix Pharma Limited (collectively hereafter referred to as the “Company” or “Tonix”). All
intercompany balances and transactions have been eliminated in consolidation.
Going Concern
The accompanying financial
statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates
the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company has suffered
recurring losses from operations and negative cash flows from operating activities. At September 30, 2023, the Company had working
capital of approximately $13.6 million. At September 30, 2023, the Company had an accumulated deficit of approximately $573.3 million.
The Company held cash and cash equivalents of approximately $6.9 million as of September 30, 2023.
The
Company believes that its cash resources at September 30, 2023 and the proceeds that it raised from equity offerings in the fourth
quarter of 2023 (See Note 20), will not meet its operating and capital expenditure requirements through the fourth quarter of 2023.
These factors raise substantial doubt about the Company’s ability
to continue as a going concern. The Company continues to face significant challenges and uncertainties and must obtain additional funding
through public and private financing and collaborative arrangements with strategic partners to increase the funds available to fund operations.
However, the Company may not be able to raise capital on terms acceptable to the Company, or at all. Without additional funds, it may
be forced to delay, scale back or eliminate some of its research and development activities, or other operations and potentially delay
product development in an effort to provide sufficient funds to continue operations. If any of these events occurs, its ability to achieve
our development and commercialization goals would be adversely affected and the Company may be forced to cease operations. The financial
statements do not include any adjustments that might result from the outcome of this uncertainty.
NOTE 2 – SIGNIFICANT ACCOUNTING
POLICIES
Interim financial statements
The unaudited condensed
consolidated interim financial statements of the Company have been prepared in accordance with accounting principles generally
accepted in the United States (“GAAP”) for interim financial information and the instructions to Form 10-Q and Article
8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial
statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a
fair presentation have been included.
The condensed consolidated
balance sheet as of December 31, 2022 contained herein has been derived from audited financial statements.
Operating results for
the three and nine months ended September 30, 2023 are not necessarily indicative of results that may be expected for the year
ending December 31, 2023. These condensed consolidated financial statements should be read in conjunction with the audited consolidated
financial statements and notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form
10-K, filed with the Securities and Exchange Commission (“SEC”) on March 13, 2023.
Reverse Stock Split
On May 9, 2023, the
Company filed a Certificate of Change with the Nevada Secretary of State, effective May 10, 2023. Pursuant to the Certificate of
Change, the Company effected a 1-for-6.25 reverse stock split of its issued and outstanding shares of common stock. The Company
accounted for the reverse stock split on a retrospective basis pursuant to ASC 260, Earnings Per Share. All authorized, issued
and outstanding common stock, common stock warrants, stock option awards, exercise prices and per share data have been adjusted
in these condensed consolidated financial statements, on a retrospective basis, to reflect the reverse stock split for all periods
presented. Authorized preferred stock was not adjusted because of the reverse stock split.
Risks and uncertainties
The Company’s primary efforts are devoted to conducting research
and development of innovative pharmaceutical and biological products to address public health challenges. The Company has experienced
net losses and negative cash flows from operations since inception and expects these conditions to continue for the foreseeable future.
Further, the Company now has commercial products available for sale, and generates revenue from the sale of its Zembrace® SymTouch®
and Tosymra® products, with no assurance that the Company will be able to generate sufficient cash flow to fund operations from its
commercial products or products in development if and when approved. In addition, there can be no assurance that the Company’s research
and development will be successfully completed or that any product will be approved or commercially viable.
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2023 AND 2022 (UNAUDITED)
Use of estimates
The preparation of financial
statements in accordance with Generally Accepted Accounting Principles (“GAAP”) requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities
at the date of the financial statements, and the reported amounts of expenses during the reporting period. Actual results could
differ from those estimates. Significant estimates include, but are not limited to, provisions for product returns, coupons, rebates,
chargebacks, discounts, allowances, inventory realization, the assumptions used in the fair value of stock-based compensation and
other equity instruments, the percent of completion of research and development contracts, fair value estimates for assets acquired
in business combinations, and assessment of useful lives of acquired intangible assets.
Business Combinations
The Company accounts
for business combinations in accordance with the provisions of ASC 805, Business Combinations and ASU No. 2017-01, Business Combinations
(Topic 805): Clarifying the Definition of a Business. Business combinations are accounted for using the acquisition method, whereby
the consideration transferred is allocated to the net assets acquired based on their respective fair values measured on the acquisition
date. The difference between the fair value of these assets and the purchase price is recorded as goodwill. Transaction costs other
than those associated with the issue of debt or equity securities, and other direct costs of a business combination are not considered
part of the business acquisition transaction and are expensed as incurred.
Segment Information and Concentrations
Operating segments are
defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating
decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views
its operations and manages its business in one segment.
The Company has two
products that each accounted for more than 10% of total revenues during the three and nine months ended September 30, 2023. These
products collectively accounted for 100% of revenues during the three and nine months ended September 30, 2023.
As
of September 30, 2023, accounts receivable from four customers accounted for 25%, 23%, 19%
and 15%
of total accounts receivable. For the three and nine months ended September 30, 2023, revenues from four customers accounted
for 25%, 21%, 18%
and 14%
of net product revenues, respectively. As of September 30, 2022, and for the three and nine months ended September 30, 2022,
the Company had no commercialized products and therefore had no accounts receivables or revenues.
Cash, Cash Equivalents and Restricted Cash
The Company considers
cash equivalents to be those investments which are highly liquid, readily convertible to cash and have an original maturity of
three months or less when purchased. At September 30, 2023 and December 31, 2022, cash equivalents, which consisted of money market
funds, amounted to $3.7 million and $116.3 million, respectively. Restricted cash, which is included in Other non-current assets
on the condensed consolidated balance sheet, at both September 30, 2023, and December 31, 2022, of approximately $244,000 and $241,000,
respectively, collateralizes a letter of credit issued in connection with the lease of office space in Chatham, New Jersey and
New York, New York (see Note 18). In addition, the Company has $758,000 of restricted cash held by vendors in escrow accounts for patient support services as of September 30, 2023.
The following table
provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets
that sum to the total of the same amounts shown in the condensed consolidated statement of cash flows:
|
|
September 30,
2023 |
|
|
September 30,
2022 |
|
|
|
(in thousands) |
|
Cash and cash equivalents |
|
$ |
6,914 |
|
|
$ |
139,978 |
|
Restricted cash |
|
|
1,002 |
|
|
|
240 |
|
Total |
|
$ |
7,916 |
|
|
$ |
140,218 |
|
Accounts Receivable, net
Accounts receivable consists of amounts due from our wholesale and other third-party distributors and pharmacies and have standard
payment terms that generally require payment within 30 to 90 days. For certain customers, the accounts receivable for the customer
is net of prompt payment or specialty pharmacy discounts. We do not adjust our receivables for the effects of a significant financing
component at contract inception if we expect to collect the receivables in one year or less from the time of sale. We provide reserves
against accounts receivable for estimated losses that may result from a customer’s inability to pay. Amounts determined to
be uncollectible are charged or written-off against the reserve. However, during the period covered by the Transition Services
Agreement, the Seller has agreed to collect the accounts receivable on behalf of the Company and net settle within 45 days from
each month-end. See note 10 for further details. The Company had no accounts receivable as of any prior period presented other than as of September 30, 2023.
As of September
30, 2023, the Company did not have an allowance for doubtful accounts. An allowance for doubtful accounts is determined based on
the financial condition and creditworthiness of customers and the Company considers economic factors and events or trends expected to
affect future collections experience. Any allowance would reduce the net receivables to the amount that is expected to be collected. The
payment history of the Company’s customers will be considered in future assessments of collectability as these patterns are established
over a longer period.
Concentration of Credit Risk
Financial instruments
that potentially subject us to concentrations of credit risk include cash and cash equivalents, and accounts receivable. We attempt
to minimize the risks related to cash and cash equivalents by investing in a broad and diverse range of financial instruments,
and we have established guidelines related to credit ratings and maturities intended to safeguard principal balances and maintain
liquidity. Concentrations of credit risk with respect to receivables, which are typically unsecured, are somewhat mitigated due
to the wide variety of customers using our products, as well as their dispersion across different geographic areas.
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2023 AND 2022 (UNAUDITED)
We monitor the financial
performance and creditworthiness of our customers so that we can properly assess and respond to changes in their credit profile.
We continue to monitor these conditions and assess their possible impact on our business.
Inventories
Inventories are recorded
at the lower of cost or net realizable value, with cost determined by the weighted average cost method. The Company periodically
reviews the composition of inventory in order to identify excess, obsolete, slow-moving or otherwise non-saleable items taking
into account anticipated future sales compared with quantities on hand, and the remaining shelf life of goods on hand. If non-saleable
items are observed and there are no alternate uses for the inventory, the Company records a write-down to net realizable value
in the period that the decline in value is first recognized. Although the Company makes every effort to ensure the accuracy of
forecasts of future product demand, any significant unanticipated decreases in demand could have a material impact on the carrying
value of inventories and reported operating results. The Company’s reserves were approximately $21,000 as of September 30,
2023. The Company did not have inventory on hand prior to the acquisition of Zembrace and Tosymra on June 30, 2023.
Property and equipment
Property and equipment
are stated at cost, less accumulated depreciation. Depreciation is calculated using the straight-line method over the asset’s
estimated useful life, which ranges from 20 to 40 years for buildings, 15 years for land improvements and laboratory equipment,
three years for computer assets, five years for furniture and all other equipment and the shorter of the useful life or term of
lease for leasehold improvements. Depreciation on assets begins when the asset is placed in service. Depreciation and amortization
expense for the three and nine months ended September 30, 2023, was $978,000 and $2.8 million, respectively, and $252,000
and $417,000, respectively, for the three and nine months ended September 30, 2022. All property and equipment are located in the
United States.
Intangible assets, net
Intangible assets deemed
to have finite lives are carried at acquisition-date fair value less accumulated amortization and impairment, if any. Finite-lived
intangible assets consist of developed technology intangible assets acquired in connection with the acquisition of certain products
from Upsher Smith Laboratories, LLS (“USL Acquisition”) consummated on June 30, 2023 (See Note 8). The acquired intangible
assets are amortized using the straight-line method over the estimated useful lives of the respective assets. Amortization expense
for the three months ended September 30, 2023, was $238,000. The annual impairment assessment date will be June 30. No triggering events were identified during the nine months ended September 30, 2023.
During the year ended
December 31, 2015, the Company purchased certain internet domain rights, which were determined to have an indefinite life. Identifiable
intangibles with indefinite lives, which are included in Intangible assets, net on the condensed consolidated balance sheet, are
not amortized but are tested for impairment annually or whenever events or changes in circumstances indicate that their carrying
amount may be less than fair value. As of September 30, 2023, the Company believed that no impairment existed.
Goodwill
Goodwill represents
the excess of the aggregate purchase price over the fair value of the net tangible and intangible assets acquired in a business
combination. Goodwill is reviewed for impairment on an annual basis, or more frequently if events or changes in circumstances indicate
that the carrying amount of goodwill may be impaired. As of September 30, 2023, the Company has recognized goodwill in connection with
the USL Acquisition consummated on June 30, 2023 (See Note 8).
Leases
The Company determines
if an arrangement is, or contains, a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”)
assets, operating lease liabilities, current and operating lease liabilities, noncurrent in the Company’s condensed consolidated
balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities
represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized
at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide
an implicit rate, the Company uses an incremental borrowing rate based on the information available at the transition date and
subsequent lease commencement dates in determining the present value of lease payments. This is the rate the Company would have
to pay if borrowing on a collateralized basis over a similar term to each lease. The operating lease ROU asset excludes lease incentives.
The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company
will exercise that option. Lease expense for lease payments made under operating leases is recognized on a straight-line basis
over the lease term.
Convertible Preferred Stock
Preferred shares subject
to mandatory redemption are classified as liability instruments and are measured at fair value. The Company classifies conditionally
redeemable preferred shares, which includes preferred shares that feature redemption rights that are either within the control
of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control, as
temporary equity (“mezzanine”) until such time as the conditions are removed or lapse.
Revenue Recognition
The
Company records and recognizes revenue in a manner that depicts the transfer of promised goods or services to customers in an
amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services.
The Company’s revenues primarily result from contracts with customers, which are generally short-term and have a single
performance obligation - the delivery of product. The Company’s performance obligation to deliver products is satisfied
at the point in time that the goods are received by the customer, which is when the customer obtains title to and has the
risks and rewards of ownership of the products, which is generally upon shipment or delivery to the customer as stipulated by
the terms of the sale agreements. The transaction price is the amount of consideration to
which the Company expects to be entitled in exchange for transferring promised goods to a customer. The consideration promised
in a contract with a customer may include fixed amounts, variable amounts, or both. Our contractual payment terms are typically 30 to 90 days.
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER
30, 2023 AND 2022 (UNAUDITED)
Revenues from product
sales, net of gross-to-net deductions, are recorded only to the extent a significant reversal in the amount of cumulative revenue
recognized is not probable of occurring and when the uncertainty associated with gross-to-net deductions is subsequently resolved.
Taxes assessed by governmental authorities and collected from customers are excluded from product sales. Shipping and handling
activities are considered to be fulfillment activities and not a separate performance obligation.
Many of the Company’s
products sold are subject to a variety of deductions. Revenues are recognized net of estimated rebates and chargebacks, cash discounts,
distributor fees, sales return provisions and other related deductions. Deductions to product sales are referred to as gross-to-net
deductions and are estimated and recorded in the period in which the related product sales occur. Accruals for these provisions
are presented in the consolidated financial statements as reductions to gross sales in determining net sales, and as a contra asset
within accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash). Amounts recorded for revenue
deductions can result from a complex series of judgements about future events and uncertainties and can rely heavily on estimates
and assumptions. The following section briefly describes the nature of the Company’s provisions for variable consideration
and how such provisions are estimated:
Chargebacks -
The Company sells a portion of its products indirectly through wholesaler distributors, and enters into specific agreements with
these indirect customers to establish pricing for the Company’s products, and in-turn, the indirect customers and entities
independently purchase these products. Because the price paid by the indirect customers and/or entities is lower than the price
paid by the wholesaler, the Company provides a credit, called a chargeback, to the wholesaler for the difference between the contractual
price with the indirect customers and the wholesale customer’s purchase price. The Company’s provision for chargebacks
is based on expected sell-through levels by the Company’s wholesale customers to the indirect customers and estimated wholesaler
inventory levels as well as historical chargeback rates. The Company continually monitors its reserve for chargebacks and adjusts
the reserve accordingly when expected chargebacks differ from actual experience.
Rebates - The
Company participates in certain government and specific sales rebate programs which provides discounted prescription drugs to qualified
recipients, and primarily relate to Medicaid and managed care rebates in the U.S., pharmacy rebates, Tri-Care rebates and discounts,
specialty pharmacy program fees and other governmental rebates or applicable allowances.
| ● | Managed Care Rebates are processed in the quarter following the quarter in which they are earned.
The managed care reporting entity submits utilization data after the end of the quarter and the Company processes the payment in
accordance with contract terms. All rebates earned but not paid are estimated by the Company according to historical payments trended
for market growth assumptions. |
| ● | Medicaid and State Agency rebates are based upon historical experience of claims submitted by various
states. The Company monitors Medicaid legislative changes to determine what impact such legislation may have on the provision for
Medicaid rebates. The accrual of State Agency reserves is based on historical payment rates. There is an approximate three-month
lag from the time of product sale until the rebate is paid. |
| ● | Tri-Care represents a regionally managed health care program for active duty and retired members,
dependents and survivors of the US military. The Tri-Care program supplements health care resources of the US military with civilian
health care professionals for greater access and quality healthcare coverage. Through the Tri-Care program, the Company provides
pharmaceuticals on a direct customer basis. Prices of pharmaceuticals sold under the Tri-Care program are pre-negotiated and a
reserve amount is established to represent the proportionate rebate amount associated with product sales. |
| ● | Coverage Gap refers to the Medicare prescription drug program and represents specifically the period
between the initial Medicare Part D prescription drug program coverage limit and the catastrophic coverage threshold. Applicable
pharmaceutical products sold during this coverage gap timeframe are discounted by the Company. Since the nature of the program
is that coverage limits are reset at the beginning of the calendar year; the payments escalate each quarter as the participants
reach the coverage limit before reaching the catastrophic coverage threshold. The Company has determined that the cost of this
reserve will be viewed as an annual cost. Therefore, the accrual will be incurred evenly during the year with quarterly review
of the liability based on payment trends and any revision to the projected annual cost. |
Prompt-Pay and other
Sales Discounts - The Company provides for prompt pay discounts, which early payments are recorded as a reduction of revenue
and as a reduction in the accounts receivable at the time of sale based on the customer’s contracted discount rate. Consumer
sales discounts represent programs the Company has in place to reduce costs to the patient. This includes copay buy down and eVoucher
programs.
Product Returns
- Consistent with industry practice, the Company offers customers a right to return any unused product. The customer’s right
of return commences typically six months prior to product expiration date and ends one year after product expiration date. Products returned
for expiration are reimbursed at current wholesale acquisition cost or indirect contract price. The Company estimates the amount
of its product sales that may be returned by the Company’s customers and accrues this estimate as a reduction of revenue
in the period the related product revenue is recognized. The Company estimates products returns as a percentage of sales to its
customers. The rate is estimated by using historical sales information, including its visibility and estimates into the inventory
remaining in the distribution channel. Adjustments are made to the current provision for returns when data suggests product returns
may differ from original estimates.
Research and Development Costs
The Company outsources
certain of its research and development efforts and expenses these costs as incurred, including the cost of manufacturing products
for testing, as well as licensing fees and costs associated with planning and conducting clinical trials. The value ascribed to
patents and other intellectual property acquired has been expensed as research and development costs, as such property is related
to particular research and development projects and had no alternative future uses.
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER
30, 2023 AND 2022 (UNAUDITED)
The Company estimates
its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under
clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations,
which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services
are provided under such contracts. The Company accounts for trial expenses according to the timing of various aspects of the trial.
The Company determines accrual estimates taking into account discussion with applicable personnel and outside service providers
as to the progress or state of consummation of trials, or the services completed.
During the course of
a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company
makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that
time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations
and other third-party vendors.
Government Grants
From time to time, the
Company may enter into arrangements with governmental entities for the purpose of obtaining funding for research and development
activities. The Company is reimbursed for costs incurred that are associated with specified research and development activities
included in the grant application approved by the government authority. The Company classifies government grants received under
these arrangements as a reduction to the related research and development expense in the same period as the relevant expenses are
incurred. In August 2022, the Company announced that it received a Cooperative Agreement grant from the National Institute on Drug
Abuse (“NIDA”), part of the National Institutes of Health, to support the development of its TNX-1300 product candidate
for the treatment of cocaine intoxication. During the three and nine months ended September 30, 2023, we received $0.4 and $2.3
million, respectively, for the three and nine months ended September 30, 2023, in funding as a reduction of related research and
development expense.
Stock-based compensation
All stock-based payments
to employees and to nonemployees for their services, including grants of restricted stock units (“RSUs”), and stock
options, are measured at fair value on the grant date and recognized in the condensed consolidated statements of operations as
compensation or other expense over the requisite service period. The Company accounts for share-based awards in accordance with
the provisions of the Accounting Standards Codification (“ASC”) 718, Compensation – Stock Compensation.
Foreign Currency Translation
Operations of the Company’s
Canadian subsidiary, Tonix Pharmaceuticals (Canada), Inc., are conducted in local currency, which represents its functional currency.
The U.S. dollar is the functional currency of the other foreign subsidiaries. Balance sheet accounts of the Canadian subsidiary
were translated from foreign currency into U.S. dollars at the exchange rate in effect at the balance sheet date and income statement
accounts were translated at the average rate of exchange prevailing during the period. Translation adjustments resulting from this
process were included in accumulated other comprehensive loss on the consolidated condensed balance sheets.
Comprehensive Income (Loss)
Comprehensive income
(loss) is defined as the change in equity of a business during a period from transactions and other events and circumstances from
non-owners sources. It includes all changes in equity during a period except those resulting from investments by owners and distributions
to owners. Other comprehensive income (loss) represents foreign currency translation adjustments.
Income Taxes
Deferred income tax
assets and liabilities are determined based on the estimated future tax effects of net operating loss and credit carryforwards
and temporary differences between the tax basis of assets and liabilities and their respective financial reporting amounts measured
at the current enacted tax rates. The Company records a valuation allowance on its deferred income tax assets if it is not more
likely than not that these deferred income tax assets will be realized.
The Company recognizes
a tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination
by taxing authorities, based on the technical merits of the position. The tax benefits recognized in the condensed consolidated
financial statements from such a position are measured based on the largest benefit that has a greater than 50% likelihood of being
realized upon ultimate settlement. As of September 30, 2023, the Company has not recorded any unrecognized tax benefits. The Company’s
policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.
Per Share Data
The computation of basic
and diluted loss per share for the quarters ended September 30, 2023 and 2022 excludes potentially dilutive securities when their
inclusion would be anti-dilutive, or if their exercise prices were greater than the average market price of the common stock during
the period.
All warrants and preferred
stock issued participate on a one-for-one basis with common stock in the distribution of dividends, if and when declared by the
Board of Directors, on the Company’s common stock. For purposes of computing EPS, these warrants and preferred stock are
considered to participate with common stock in earnings of the Company. Therefore, the Company calculates basic and diluted EPS
using the two-class method. Under the two-class method, net income for the period is allocated between common stockholders and
participating securities according to dividends declared and participation rights in undistributed earnings. No income was allocated
to the warrants and preferred stock for the three and nine months ended September 30, 2023, and 2022, as results of operations
were a loss for the periods.
Potentially dilutive
securities excluded from the computation of basic and diluted net loss per share, as of September 30, 2023 and 2022, are as follows:
|
|
2023 |
|
|
2022 |
|
Warrants to purchase common stock |
|
|
7,003,196 |
|
|
|
3,196 |
|
Options to purchase common stock |
|
|
1,384,264 |
|
|
|
392,643 |
|
Totals |
|
|
8,387,460 |
|
|
|
395,839 |
|
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER
30, 2023 AND 2022 (UNAUDITED)
Recently Adopted Accounting Pronouncements
In August 2020, the
FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts
in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity,
which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU
also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative scope exception,
and it also simplifies the diluted earnings per share calculation in certain areas. The Company adopted ASU 2020-06 on January
1, 2023, under the modified retrospective method of transition. The adoption of ASU 2020-06 did not impact the Company’s
financial position, results of operations or cash flows.
In June 2016, the FASB
issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments. The main objective of ASU 2016-13 is to provide financial
statement users with more decision-useful information about an entity’s expected credit losses on financial instruments and
other commitments to extend credit at each reporting date. To achieve this objective, the amendments in this update replace the
incurred loss impairment methodology currently used today with a methodology that reflects expected credit losses and requires
consideration of a broader range of reasonable and supportable information to develop credit loss estimates. ASU 2016-13 will be
effective for the Company for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years,
using a modified retrospective approach. Early adoption is permitted. The Company adopted ASU 2016-13 and related updates as of
January 1, 2023. The adoption of ASU 2016-13 did not impact the Company’s financial position, results of operations or cash
flows.
NOTE 3 – INVENTORY
The components of inventory
consisted of the following as of September 30, 2023:
|
|
September
30,
2023 |
|
|
December
31,
2022 |
|
|
|
(in
thousands) |
|
Raw Materials |
|
$ |
3,064 |
|
|
$ |
— |
|
Work-in-process |
|
|
1,565 |
|
|
|
— |
|
Finished Goods |
|
|
8,709 |
|
|
|
— |
|
|
|
|
13,338 |
|
|
$ |
— |
|
Less: Inventory reserves |
|
|
(21 |
) |
|
|
— |
|
Total Inventory |
|
$ |
13,317 |
|
|
$ |
— |
|
NOTE 4 – PROPERTY AND EQUIPMENT,
NET
Property and equipment,
net consisted of the following (in thousands):
|
|
September 30,
2023 |
|
|
December 31,
2022 |
|
|
|
(in thousands) |
|
Property and equipment, net: |
|
|
|
|
|
|
|
|
Land |
|
$ |
8,011 |
|
|
$ |
8,011 |
|
Land improvements |
|
|
326 |
|
|
|
79 |
|
Buildings |
|
|
65,825 |
|
|
|
65,644 |
|
Office furniture and equipment |
|
|
2,355 |
|
|
|
1,893 |
|
Laboratory equipment |
|
|
21,506 |
|
|
|
18,440 |
|
Leasehold improvements |
|
|
34 |
|
|
|
34 |
|
Construction in progress |
|
|
1,204 |
|
|
|
1,366 |
|
|
|
|
99,261 |
|
|
|
95,467 |
|
Less: Accumulated depreciation and amortization |
|
|
(4,395 |
) |
|
|
(1,653 |
) |
|
|
$ |
94,866 |
|
|
$ |
93,814 |
|
On October 1, 2021,
the Company completed the acquisition of its approximately 45,000 square foot research and development facility in Frederick, Maryland
totaling $17.5 million, to process development activities. Of the total purchase price, $2.1 million was allocated to the value
of land acquired, and $13.9 million was allocated to buildings, and approximately $1.5 million was allocated to office furniture
and equipment and laboratory equipment. During 2022, the assets became ready for the intended use and were placed in service.
On September 28, 2020,
the Company completed the purchase of its approximately 45,000 square foot facility in Dartmouth, Massachusetts for $4.0 million,
to house its new Advanced Development Center for the development and manufacturing of vaccines. Of the total purchase price, $1.2
million was allocated to the value of land acquired, and $2.8 million was allocated to buildings. Additionally, the Company incurred
approximately $38.8 million of costs during the year ended December 31, 2022, bringing total costs incurred-to-date to $61.6 million,
of which the majority related to the build-out of the facility. During 2022, the assets became ready for the intended use and were
placed in service.
On December 23, 2020,
the Company completed the purchase of its approximately 44-acre site in Hamilton, Montana for $4.5 million, for the construction
of a vaccine development and commercial scale manufacturing facility. As of September 30, 2023, the asset was not ready for its
intended use.
During the quarter ended
September 30, 2023, property and equipment with a net book value of approximately $0.8 million were sold for net proceeds of approximately
$1.0 million.
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER
30, 2023 AND 2022 (UNAUDITED)
NOTE 5 – GOODWILL AND INTANGIBLE ASSETS
The following table
provides the gross carrying value of goodwill as follows:
|
|
Amounts |
|
|
|
(in thousands) |
Balance at December 31, 2022 |
|
$ |
— |
|
Acquired during the period (see Note 8) |
|
|
965 |
|
Balance at September 30, 2023 |
|
$ |
965 |
|
The following table
provides the gross carrying amount and accumulated amortization for each major class of intangible asset:
|
|
September 30,
2023 |
|
|
December 31,
2022 |
|
|
|
(in thousands) |
|
Intangible assets subject to amortization |
|
|
|
|
|
|
|
|
Developed technology |
|
$ |
10,100 |
|
|
$ |
— |
|
Less: Accumulated amortization |
|
|
238 |
|
|
|
— |
|
Total |
|
$ |
9,862 |
|
|
$ |
— |
|
Intangible assets not subject to amortization |
|
|
|
|
|
|
|
|
Internet domain rights |
|
$ |
120 |
|
|
$ |
120 |
|
Total intangible assets, net |
|
$ |
9,982 |
|
|
$ |
120 |
|
During the three months ended September 30,
2023, the Company recorded amortization of $238,000.
At September 30, 2023,
the related amortization for each of the next five years ended December 31 is as follows (in thousands):
Year Ending December 31, |
|
|
|
|
Remainder of 2023 |
|
|
$ |
238 |
|
2024 |
|
|
|
953 |
|
2025 |
|
|
|
953 |
|
2026 |
|
|
|
953 |
|
2027 and beyond |
|
|
|
6,765 |
|
|
|
|
$ |
9,862 |
|
NOTE 6 – FAIR VALUE MEASUREMENTS
Fair
value measurements affect the Company’s accounting for certain of its financial assets. Fair value is defined as 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 and is measured according to a hierarchy that includes:
|
Level
1: |
Observable
inputs, such as quoted prices in active markets. |
|
Level
2: |
Inputs,
other than quoted prices in active markets, that are observable either directly or indirectly. Level 2 assets and liabilities
include debt securities with quoted market prices that are traded less frequently than exchange-traded instruments. This category
includes U.S. government agency-backed debt securities and corporate-debt securities. |
|
Level 3: |
Unobservable
inputs in which there is little or no market data. |
As of September 30,
2023, and December 31, 2022, the Company used Level 1 quoted prices in active markets to value cash equivalents of $3.7 million
and $116.3 million, respectively. The Company did not have any Level 2 or Level 3 assets or liabilities as of both September 30,
2023 and December 31, 2022.
NOTE 7 – STOCKHOLDERS’ EQUITY
On May 9, 2023, the
Company filed a Certificate of Change with the Nevada Secretary of State, effective May 10, 2023. Pursuant to the Certificate of
Change, the Company effected a 1-for-6.25 reverse stock split of its issued and outstanding shares of common stock, whereby 64,627,246
outstanding shares of the Company’s common stock were exchanged for 10,340,506 shares of the Company’s common stock.
In connection with the reverse stock split, the Company issued an additional 131,902 shares of the Company’s common stock
due to fractional shares. Furthermore, pursuant to the Certificate of Change, the number of authorized shares of common stock was
reduced from 1,000,000,000 to 160,000,000. All per share amounts and number of shares in the condensed consolidated financial statements
and related notes have been retroactively restated to reflect the reverse stock split.
On October 17, 2023,
the Company received a letter from the Listing Qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”)
indicating that, based upon the closing bid price of the Company’s common stock for the last 30 consecutive business days,
the Company no longer meets the requirement to maintain a minimum bid price of $1 per share, as set forth in Nasdaq Listing Rule
55450(a)(1) (the “Minimum Bid Price Requirement”).
TONIX PHARMACEUTICALS HOLDING CORP.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2023 AND 2022 (UNAUDITED)
The
Company was initially provided with a 180
calendar day period, or until April 15, 2024, in which to regain compliance. In the event that the Company does not regain compliance
within this 180-day
period, the Company may be eligible to seek an additional 180
day compliance period if it meets the continued listing requirement for market value of publicly held shares and all other initial listing
standards for the Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and provides written notice to Nasdaq
of its intent to cure the deficiency during this second compliance period, by effecting a reverse stock split, if necessary.
NOTE 8 – TEMPORARY EQUITY
On October 26, 2022,
the Company closed on an offering (“the October offering”) with certain institutional investors (the “Investors”),
pursuant to which the Company issued and sold, in a private placement, 1,400,000 shares of the Company’s Series A Convertible
Redeemable Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”), and 100,000 shares of the
Company’s Series B Convertible Redeemable Preferred Stock, par value $0.001 per share (the “Series B Preferred Stock,”
and together with the Series A Preferred Stock, the “Preferred Stock”), at an offering price of $9.50 per share, representing
a 5% original issue discount (“OID) to the stated value of $10.00 per share, for gross proceeds of $14.3 million in the aggregate
for the October offering, before the deduction of fees and offering expenses. The shares of Preferred Stock were convertible, at
a conversion price of $6.25 per share (subject in certain circumstances to adjustments), into shares of the Company’s common
stock, at the option of the holders and, in certain circumstances, by the Company.
On December 13, 2022,
an amendment (the “December Amendment”) to the Company’s Articles of Incorporation, as amended, to increase the
Company’s authorized shares of common stock from 24,000,000 to 160,000,000, as adjusted for the reverse split, was approved
at a special meeting of shareholders. The Series A Preferred Stock had the right to vote on such December Amendment on an as-converted
to common stock basis. The shares of the Series B Preferred Stock were automatically voted in a manner that “mirrored”
the proportions on which the shares of common stock (excluding any shares of common stock that were not voted) and Series A Preferred
Stock were voted to increase the Authorized Shares. The December Amendment required the approval of the majority of the votes associated
with the Company’s outstanding stock entitled to vote on the proposal. Because the Series B Preferred Stock were automatically
and without further action of the purchaser voted in a manner that “mirrored” the proportions on which the shares of
common stock (excluding any shares of common stock that were not voted) and Series A Preferred Stock were voted on the December
Amendment, abstentions by common stockholders did not have any effect on the votes cast by the holders of the Series B Preferred
Stock. The Certificates of Designation for the Preferred Stock provides that the Preferred Stock have no voting rights other than
the right to vote on the December Amendment and as a class on certain other specified matters, and, with respect to the Series
B Certificate of Designation, the right to cast 2,500 votes per share of Series B Preferred Stock on the December Amendment.
The holders of Preferred
Stock were entitled to dividends, on an as-if converted basis, equal to dividends actually paid, if any, on shares of common stock.
The Preferred Stock was convertible, at the option of the holders and, in certain circumstances, by the Company, into shares of
common stock at a conversion price of $6.25 per share. The holders of the Preferred Stock had the right to require the Company
to redeem their shares of preferred stock for cash at 105% of the stated value of such shares through January 23, 2023. The Company
had the option to redeem the Preferred Stock for cash at 105% of the stated value, subject to the holders’ rights to convert
the shares prior to such redemption.
The $14.3 million in
gross proceeds of the October offering was held in an escrow account, along with an additional $1.5 million deposited by the Company
to cover the aggregate OID as well as the additional amount that would be necessary to fund the 105% redemption price until the
expiration of the redemption period for the Preferred Stock, as applicable, subject to the earlier payment to redeeming holders.
Upon expiration of the redemption period, any proceeds remaining in the escrow account would be disbursed to the Company.
Since the Preferred
Stock had a redemption feature at the option of the holder, it was classified as temporary equity. The Series A Preferred Stock
and Series B Preferred Stock was recorded at redemption value of approximately $14.7 million and $1.1 million, respectively, as
calculated in the following table (in thousands):
|
|
Series A Preferred Stock |
|
|
Series B Preferred Stock |
|
Gross Proceeds |
|
$ |
13,300 |
|
|
$ |
950 |
|
Less: |
|
|
|
|
|
|
|
|
Preferred stock issuance costs |
|
|
(844 |
) |
|
|
(60 |
) |
Plus: |
|
|
|
|
|
|
|
|
Accretion of carrying value to redemption value |
|
|
2,244 |
|
|
|
160 |
|
Preferred stock subject to possible redemption |
|
$ |
14,700 |
|
|
$ |
1,050 |
|
During December 2022,
the Company received redemption notices for all outstanding shares of Preferred Stock. The Preferred Stock was redeemed during
December 2022 at 105% of the $10.00 stated value of the Preferred Stock, or $15.8 million in the aggregate.
On June 24, 2022, the
Company closed on an offering (“the Offering”) with certain institutional investors (the “Investors”),
pursuant to which the Company issued and sold, in a private placement, 2,500,000 shares of the Company’s Series A Convertible
Redeemable Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”), and 500,000 shares of the
Company’s Series B Convertible Redeemable Preferred Stock, par value $0.001 per share (the “Series B Preferred Stock,”
and together with the Series A Preferred Stock, the “Preferred Stock”), at an offering price of $9.50 per share, representing
a 5% OID to the stated value of $10.00 per share, for gross proceeds of $28.5 million in the aggregate for the Offering, before
the deduction of fees and offering expenses. The shares of Preferred Stock were convertible, at a conversion price of $25.00 per
share (subject in certain circumstances to adjustments), into shares of the Company’s common stock, at the option of the
holders and, in certain circumstances, by the Company.
On August 5, 2022, an
amendment (the “Amendment”) to the Company’s Articles of Incorporation, as amended, to increase the Company’s
authorized shares of common stock from 8,000,000 to 24,000,000, as adjusted for the reverse split, was approved at a special meeting
of shareholders. The Series A Preferred Stock had the right to vote on such Amendment on an as-converted to common stock basis.
The shares of the Series B Preferred Stock were automatically voted in a manner that “mirrored” the proportions on
which the shares of common stock (excluding any shares of common stock that were not voted) and Series A Preferred Stock were voted
to increase the Authorized Shares. The Amendment required the approval of the majority of the votes associated with the Company’s
outstanding stock entitled to vote on the proposal. Because the Series B Preferred Stock were automatically and without further
action of the purchaser voted in a manner that “mirrored” the proportions on which the shares of common stock (excluding
any shares of common stock that were not voted) and Series A Preferred Stock were voted on the Amendment, abstentions by common
stockholders did not have any effect on the votes cast by the holders of the Series B Preferred Stock. The Certificates of Designation
for the Preferred Stock provides that the Preferred Stock have no voting rights other than the right to vote on the Amendment and
as a class on certain other specified matters, and, with respect to the Series B Certificate of Designation, the right to cast
2,500 votes per share of Series B Preferred Stock on the Amendment.
The holders of Preferred
Stock were entitled to dividends, on an as-if converted basis, equal to dividends actually paid, if any, on shares of common stock.
The Preferred Stock was convertible, at the option of the holders and, in certain circumstances, by the Company, into shares of
common stock at a conversion price of $25.00 per share. The holders of the Preferred Stock had the right to require the Company
to redeem their shares of preferred stock for cash at 105% of the stated value of such shares through September 22, 2022. The Company
had the option to redeem the Preferred Stock for cash at 105% of the stated value, subject to the holders’ rights to convert
the shares prior to such redemption.
The $28.5 million in
gross proceeds of the Offering was held in an escrow account, along with an additional $3.0 million deposited by the Company to
cover the aggregate OID as well as the additional amount that would be necessary to fund the 105% redemption price until the expiration
of the redemption period for the Preferred Stock, as applicable, subject to the earlier payment to redeeming holders. Upon expiration
of the redemption period, any proceeds remaining in the escrow account would be disbursed to the Company.
Since the Preferred
Stock had a redemption feature at the option of the holder, it was classified as temporary equity. The Series A Preferred Stock
and Series B Preferred Stock was recorded at redemption value of approximately $26.3 million and $5.2 million, respectively, as
calculated in the following table (in thousands):
|
|
Series A Preferred Stock |
|
|
Series B Preferred Stock |
|
Gross Proceeds |
|
$ |
23,750 |
|
|
$ |
4,750 |
|
Less: |
|
|
|
|
|
|
|
|
Preferred stock issuance costs |
|
|
(1,046 |
) |
|
|
(209 |
) |
Plus: |
|
|
|
|
|
|
|
|
Accretion of carrying value to redemption value |
|
|
3,546 |
|
|
|
709 |
|
Preferred stock subject to possible redemption |
|
$ |
26,250 |
|
|
$ |
5,250 |
|
During August 2022,
the Company received redemption notices for all outstanding shares of Preferred Stock. The Preferred Stock was redeemed during
August 2022 at 105% of the $10.00 stated value of the Preferred Stock, or $31.5 million in the aggregate.
NOTE 9 – REVENUES
Disaggregation of Net Revenues
The Company’s net product revenues
are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months Ended September 30, |
|
|
Nine
Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Zembrace® Symtouch® |
|
$ |
3,292 |
|
|
$ |
— |
|
|
$ |
3,292 |
|
|
$ |
— |
|
Tosymra® |
|
|
697 |
|
|
$ |
— |
|
|
$ |
697 |
|
|
$ |
— |
|
Total product revenues |
|
$ |
3,989 |
|
|
$ |
— |
|
|
$ |
3,989 |
|
|
$ |
— |
|
Gross-to-Net Sales Accruals
We record gross-to-net
sales accruals for chargebacks, rebates, sales and other discounts, and product returns, which are all customary to the pharmaceutical
industry.
Our provision for gross-to-net allowances
was $2.5 million at September 30, 2023, $0.7 million of which was recorded as a reduction to accounts receivable and $1.8 million
recorded as a component of accrued expenses.
NOTE 10 – ASSET PURCHASE AGREEMENT WITH UPSHER-SMITH
On June 30, 2023, the Company completed the acquisition of certain assets from Upsher-Smith Laboratories LLC ("USL") related to Zembrace® SymTouch® (sumatriptan
injection) 3 mg (“Zembrace”) and Tosymra® (sumatriptan nasal spray) 10 mg (“Tosymra”) products (such
businesses collectively, the “Business”) and certain inventory related to the Business for an aggregate purchase price
of approximately $26.5 million, including certain deferred payments and subject to customary adjustments (such transaction, the
“USL Acquisition”).
On June 30, 2023, in
connection with the USL Acquisition, the Company and USL entered into a Transition Services Agreement (the “Transition Services
Agreement”), pursuant to which USL will provide certain transition services to the Company for base fees equal to $100,000
per month for the first six months, and $150,000 per months for the seventh through ninth months, plus additional monthly fees
for each service category totaling up to $150,000 per month.
The Company
has assumed certain obligations of Seller, including the payment of quarterly earn-out payments on annual net sales from the Business
in the U.S. as follows: for Tosymra, 4% for net sales of $0 to $30 million, 7% of net sales of $30 to $75 million; 9% for net sales of
$75 to $100 million; 12% for net sales of $100 to $150 million; and 15% for net sales greater than $150 million. Earn-out payments with
respect to Tosymra are payable until the expiration or termination of the product’s Orange Book listed patent(s) with respect to
the United States or, outside the United States, the expiration of the last valid claim covering the product in the relevant country of
the territory. For Zembrace, earn-out payments on annual net sales in the U.S. are 3% for net sales of $0 to $30 million, 6% of net sales
of $30 to $75 million; 12% for net sales of $75 to $100 million; 16% for net sales of greater than $100 million. Such earn-out payments
are payable until July 19, 2025. Upon the entry of a generic version of the relevant product, the applicable earn-out rates shall be reduced
by 90% percent with respect to Zembrace, and by 66.7% percent for Tosymra. Prior to Purchaser or a licensee filing an application for
marketing authorization for either of the products in a permitted country outside the U.S., the parties will negotiate in good faith the
earn-out payment rates annual net sales tiers that will apply for such country, based on the market opportunity for the product in such
country. If the parties fail to agree, then the earn-out payment rates and annual net sales tiers described above will apply.
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
SEPTEMBER
30, 2023 AND 2022 (UNAUDITED)
In addition,
the Company has assumed the obligation to pay an additional 3% royalty on net sales of Tosymra, plus an additional 3% if a patent containing
certain claims related to Tosymra issues in the U.S., for 15 years from the first commercial sale of Tosymra in the applicable country
or for as long as the manufacture, use or sale of Tosymra in such country is covered by a valid claim of a licensed patent, and up to
$15 million per Tosymra product on the achievement of sales milestones.
As
consideration for acquisition of the Business and certain product-related inventories, the Company paid approximately $23.5
million in cash upfront. On the earlier of March
2024 and the completion of the transition services to be provided by USL, as described above, the Company agreed to pay an additional
deferred payment of $3.0
million in cash, which is included in Accrued expenses and other current liabilities on
the accompanying balance sheet. The following table summarizes the components of the purchase consideration (in thousands):
Preliminary purchase consideration |
|
Amount |
|
Closing cash consideration |
|
$ |
22,174 |
|
Inventory adjustment payment liability |
|
|
1,348 |
|
Deferred payment liability |
|
|
3,000 |
|
Purchase price to be allocated |
|
$ |
26,522 |
|
The USL Acquisition
was accounted for as a business combination using the acquisition method, in accordance with the provisions of ASC 805, Business
Combinations and ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. The tangible
and intangible assets acquired were recorded at their estimated fair values on the acquisition date, and the difference between
the fair value of these assets and the purchase price has been recorded as goodwill. The purchase price allocation is based upon
preliminary valuations and estimates and assumptions which are subject to change. As the Company receives additional information
about facts and circumstances that existed at the acquisition date, the fair values of the acquired inventory and intangible assets
may be adjusted, with the offset recorded to goodwill. The acquisition-date fair value analyses will be finalized as soon as practicable,
but in no event later than one year after the acquisition date.
The following table
represents the preliminary allocation of the purchase price to the assets acquired by the Company in the USL Acquisition recognized
in the Company’s consolidated balance sheets (in thousands):
Preliminary purchase price allocation |
|
Amount |
|
Inventory |
|
$ |
13,700 |
|
Prepaid expenses and other |
|
|
1,757 |
|
Intangible assets, net |
|
|
10,100 |
|
Goodwill |
|
|
965 |
|
Fair value of assets acquired |
|
$ |
26,522 |
|
The acquired inventory
consists of USL’s raw materials, semi-finished goods, and finished goods inventory as of the Closing date. The fair value
was determined based on the estimated selling price of the inventory, less the estimated total costs to complete, disposal effort
and holding costs.
The $1.0 million of
goodwill arising from the USL Acquisition represents expected synergies from combining operations, intangible assets that do not
qualify for separate recognition, and other factors, of which all is expected to be deductible for tax purposes, subject to any
limitations.
Intangible assets eligible
for recognition separate from goodwill were those that satisfied either the contractual or legal criterion or the separability
criterion in the accounting guidance. The identifiable intangible assets acquired and their estimated useful lives for amortization
are as follows (in thousands):
|
|
Fair Value |
|
|
Useful Life
(years) |
|
Developed technology - Tosymra |
|
$ |
3,400 |
|
|
|
9 |
|
Developed technology - Zembrace |
|
|
6,700 |
|
|
|
14 |
|
Total |
|
$ |
10,100 |
|
|
|
|
|
The developed technology
intangible assets related to Zembrace and Tosymra includes the value associated with the acquired patents, customer relationships,
and trademarks and trade names associated with the technology. The developed technology intangible assets were valued as composite
assets under the premise that each asset is reliant on one another to generate cash flow, is not considered separable from the
technology, and are assumed to have similar useful lives. The composite intangible assets were valued using a multi-period excess
earnings method and are being amortized over their estimated useful lives using the straight-line method of amortization. The key
assumptions used in estimating the fair values of intangible assets include forecasted financial information, the weighted average
cost of capital, customer retention rates, and certain other assumptions.
The fair values assigned
to the assets acquired are based on reasonable assumptions and estimates that market participants would use. Actual results may
differ from these estimates and assumptions.
Supplemental Pro Forma Information
The following unaudited
pro forma consolidated financial information reflects the results of operations of the Company for the three and nine months ended
September 30, 2023 and 2022 as if the USL Acquisition had occurred as of January 1, 2022 and gives effect to transactions that
are directly attributable to the acquisition. These amounts are based on financial information of the acquired business and are
not necessarily indicative of what the Company’s operating results would have been had the acquisition taken place on the
date presented, nor is it indicative of the Company’s future operating results.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Net Product Sales |
|
$ |
3,989 |
|
|
$ |
3,635 |
|
|
$ |
11,610 |
|
|
$ |
7,612 |
|
Net Loss |
|
$ |
(27,072 |
) |
|
$ |
(33,698 |
) |
|
$ |
(91,252 |
) |
|
$ |
(95,073 |
) |
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
SEPTEMBER
30, 2023 AND 2022 (UNAUDITED)
The pro forma information
for all periods presented include additional amortization expense related to the fair value of the acquired intangible assets as
if such assets were acquired on January 1, 2022. The pro forma financial information for the three and nine months ended September
30, 2022 also reflects an increase in Cost of Sales related to the preliminary acquisition-date fair value adjustment to inventory.
This adjustment is not reflected in the three and nine months ended September 30, 2023 as the acquired inventory is expected to
be sold within one year from the acquisition date.
As described above,
in connection with the USL Acquisition, the Company and USL entered into a Transition Services Agreement with the Seller related
to providing ongoing services associated with the assets acquired, such as procuring and selling migraine therapy products, providing
accounting and billing services and collecting accounts receivable and paying trade payables. The Seller collected and will continue
to collect cash on behalf of Tonix for revenue generated by sales of the assets acquired from June 30, 2023 through the transition
period and the Seller is obligated to transfer cash generated by such sales to the Buyer.
The
amount due to USL for reimbursement of services performed under the transition services agreement was $498,000
as of September 30, 2023. The transition service fees were netted against the receivables collected of $4,784,000
and liabilities paid of $2,724,000
on behalf of the Company with the net amount due to the Company of $1,562,000
recorded within receivables, net on the condensed consolidated balance sheet as of September 30, 2023.
NOTE 11 – ASSET PURCHASE AGREEMENT
WITH HEALION
On
February 2, 2023, the Company entered into an asset purchase agreement (the “Healion Asset Purchase Agreement”) with Healion
Bio Inc., (“Healion”) pursuant to which the Company acquired all the pre-clinical infectious disease assets of Healion, including
its portfolio of next-generation antiviral technology assets. Healion’s drug portfolio includes a class of broad-spectrum small
molecule oral antiviral drug candidates with a novel host-directed mechanism of action, including TNX-3900, formerly known as HB-121.
As consideration for entering into the Healion Asset Purchase Agreement, the Company paid $1.2
million to Healion. Because the Healion intellectual property was acquired prior to U.S. Food and Drug Administration (FDA) approval,
the cash consideration totaling $1.2
million, was expensed as research and development costs since there is no alternative future use and the acquired intellectual
property does not constitute a business.
NOTE 12 – LICENSE AGREEMENT WITH CURIA
On December 12, 2022,
the Company entered into an exclusive license agreement with Curia for the development of three humanized murine mAbs for the treatment
or prophylaxis of SARS-CoV-2 infection. We believe that the licensing of these mAbs strengthens our pipeline of next-generation
therapeutics to treat COVID-19, which is caused by SARS-CoV-2. As consideration for entering into the License Agreement, we paid
a license fee of approximately $0.4 million to Curia. The License Agreement also provides for single-digit royalties and contingent
milestone payments. As of September 30, 2023, other than the upfront fee, no payments have been accrued or paid in relation to
this agreement.
NOTE 13 – LICENSE AGREEMENT WITH UNIVERSITY OF ALBERTA
On May 18, 2022, the Company entered into an exclusive License Agreement with the University of Alberta focused on identifying and testing broad-spectrum antiviral drugs against future variants of SARS-CoV-2 and other emerging viruses. As consideration for entering into the License Agreement, Tonix paid a low-five digit license fee to University of Alberta. The License Agreement also provides for single-digit royalties and contingent milestone payments. As of September 30, 2023, other than the upfront fee, no milestone payments have been accrued or paid in relation to this agreement.
NOTE
14 – LICENSE AGREEMENTS WITH COLUMBIA UNIVERSITY
On February 13, 2023,
Tonix exercised an option to obtain an exclusive license from Columbia for the development of a portfolio of both fully human and
murine mAbs for the treatment or prophylaxis of SARS-CoV-2 infection, including our TNX-3600 and TNX-4100 product candidates, respectively.
The licensed mAbs were developed as part of a research collaboration and option agreement between Tonix and Columbia.
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
SEPTEMBER
30, 2023 AND 2022 (UNAUDITED)
NOTE 15 – SALE OF COMMON STOCK
July 2023 Financing
On July 27, 2023, the
Company sold 2,530,000 shares of common stock; pre-funded warrants
to purchase up to 4,470,000 shares of common stock, and accompanying common warrants to purchase up to 7,000,000 shares of common
stock with an exercise price of $1.00 per share in a public offering that closed on August 1, 2023. The offering price per share of common stock and accompanying common warrant was
$1.00, and the offering price per share of pre-funded warrant and accompanying common warrant was $0.9999.
The Company incurred offering expenses of approximately $0.7 million, including placement agent fees of approximately
$0.5 million. The Company received net proceeds of approximately $6.3 million, after deducting the underwriting discount and other
offering expenses.
2022 Lincoln Park Transaction
On August 16, 2022, the Company
entered into an equity line of credit with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park
agreed to purchase up to $50,000,000 of the Company’s common stock (subject to certain limitations) from time to time. The Company
filed with the SEC a registration statement to register for resale under the Securities Act the shares that have been or may be issued
to Lincoln Park under the 2022 Purchase Agreement. The Company issued 100,000 shares of common stock to Lincoln Park as consideration
for its commitment to purchase shares of the Company’s common stock. The commitment shares were valued at $1,000,000 and recorded
as an addition to equity for the issuance of the common stock and treated as a reduction to equity as a cost of capital to be raised under
the equity line of credit.
During the three and nine
months ended September 30, 2023, the Company sold 0 and 0.1 million shares, respectively, of common stock under the equity line of credit
with Lincoln Park, for net proceeds of approximately $0 and $0.4 million, respectively.
During the nine months ended
September 30, 2022, no shares of common stock were sold under the equity line of credit.
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
SEPTEMBER
30, 2023 AND 2022 (UNAUDITED)
Purchase Agreement with Lincoln Park
On December 3, 2021,
the Company entered into a purchase agreement (the “Purchase Agreement with Lincoln Park”) and a registration rights
agreement (the “Lincoln Park Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”).
Pursuant to the terms of the Purchase Agreement with Lincoln Park, Lincoln Park agreed to purchase from the Company up to $80,000,000
of the Company’s common stock (subject to certain limitations) from time to time during the term of the Purchase Agreement
with Lincoln Park. Pursuant to the terms of the Lincoln Park Registration Rights Agreement, the Company filed with the SEC a registration
statement to register for resale under the Securities Act the shares that have been or may be issued to Lincoln Park under the
Purchase Agreement with Lincoln Park.
Pursuant to the terms
of the Purchase Agreement with Lincoln Park, at the time the Company signed the Purchase Agreement with Lincoln Park and the Lincoln
Park Registration Rights Agreement, the Company issued 14,546 shares of common stock to Lincoln Park as consideration for its commitment
to purchase shares of our common stock under the Purchase Agreement with Lincoln Park. The commitment shares were valued at $1.6
million and recorded as an addition to equity for the issuance of the common stock and treated as a reduction to equity as a cost
of capital to be raised under the Purchase Agreement with Lincoln Park.
During the nine months
ended September 30, 2022, the Company sold 0.5 million shares of common stock under the Purchase Agreement with Lincoln Park, for
net proceeds of approximately $8.7 million. No sales occurred in 2023.
Under applicable rules
of the NASDAQ Global Market, the Company could not issue or sell more than 19.99% of the shares of its common stock outstanding
immediately prior to the execution of the Purchase Agreement with Lincoln Park (approximately 0.5 million shares) to Lincoln Park
under the Purchase Agreement with Lincoln Park without stockholder approval, unless the average price of all applicable sales of
its common stock to Lincoln Park under the Purchase Agreement with Lincoln Park equals or exceeds a threshold amount. As the Company
has issued approximately 0.4 million shares to Lincoln Park, by September 30, 2022, under the Purchase Agreement with Lincoln Park
at less than the threshold amount, the Company will not sell any additional shares under the Purchase Agreement with Lincoln Park
without shareholder approval.
At-the-Market Offerings
On April 8, 2020, the Company entered into a sales agreement
with AGP pursuant to which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $320.0
million in at-the-market offerings (“ATM”) sales at prevailing market prices at the time of the sale, and, as a result, prices
will vary. AGP receives a 3% commission on each ATM sale under the Sales Agreement.
During
the three and nine months ended September 30, 2023, the Company sold approximately 0 and 1.0 million shares, respectively, of
common stock under the Sales Agreement, for net proceeds of approximately $0 million and $3.0 million, respectively. During the
nine months ended September 30, 2022, the Company sold approximately 5.5 million shares of common stock under the Sales Agreement,
for net proceeds of approximately $76.2 million.
Stock Repurchases
During the first quarter
of 2023, the Company has repurchased 2,512,044 of its shares of common stock outstanding under the 2022 share repurchase program
for up to $12.5 million at prices ranging from $2.75 to $8.61 per share for a gross aggregate cost of approximately $12.5 million.
In addition, the Company incurred expenses of $0.3 million.
In
January 2023, the Board of Directors approved a new 2023 share repurchase program pursuant to which the Company
may repurchase up to an additional $12.5
million in value of its outstanding common stock from time to time on the open market and in privately negotiated transactions
subject to market conditions, share price and other factors. During the first quarter of 2023, the Company has repurchased 160,000
of our shares of common stock outstanding under the new 2023 share repurchase program at $7.12
per share for a gross aggregate cost of $1.1
million. No additional repurchases have occurred since the first quarter of 2023.
The timing and amount
of any shares repurchased will be determined based on the Company’s evaluation of market conditions and other factors
and the New Share Repurchase Program may be discontinued or suspended at any time. Repurchases will be made
in accordance with the rules and regulations promulgated by the Securities and Exchange Commission and certain other legal requirements
to which the Company may be subject. Repurchases may be made, in part, under a Rule 10b5-1 plan, which allows stock repurchases when
the Company might otherwise be precluded from doing so.
NOTE
16 – STOCK-BASED COMPENSATION
On May 1, 2020, the
Company’s stockholders approved the Tonix Pharmaceuticals Holding Corp. Amended and Restated 2020 Stock Incentive Plan (“Amended
and Restated 2020 Plan”).
Under the terms of the
Amended and Restated 2020 Plan, the Company may issue (1) stock options (incentive and nonstatutory), (2) restricted stock, (3)
stock appreciation rights (“SARs”), (4) RSUs, (5) other stock-based awards, and (6) cash-based awards. The Amended
and Restated 2020 Plan initially provided for the issuance of up to 50,000 shares of common stock, which amount will be increased
to the extent that awards granted under the Plans are forfeited, expire or are settled for cash (except as otherwise provided in
the Amended and Restated 2020 Plan). In addition, the Amended and Restated 2020 Plan contains an “evergreen provision”
providing for an annual increase in the number of shares of our common stock available for issuance under the Amended and Restated
2020 Plan on January 1 of each year for a period of ten years, commencing on January 1, 2021 and ending on (and including) January
1, 2030, in an amount equal to the difference between (x) twenty percent (20%) of the total number of shares of common stock outstanding
on December 31st of the preceding calendar year, and (y) the total number of shares of common stock reserved under the Amended
and Restated 2020 Plan on December 31st of such preceding calendar year (including shares subject to outstanding awards,
issued pursuant to awards or available for future awards). The Board of Directors determines the exercise price, vesting and expiration
period of the grants under the Amended and Restated 2020 Plan. However, the exercise price of an incentive stock option may not
be less than 110% of fair value of the common stock at the date of the grant for a 10% or more shareholder and 100% of fair value
for a grantee who is not a 10% shareholder. The fair value of the common stock is determined based on quoted market price or in
absence of such quoted market price, by the Board of Directors in good faith. Additionally, the expiration period of grants under
the Amended and Restated 2020 Plan may not be more than ten years. As of September 30, 2023, 1,062,874 options were available for
future grants under the Amended and Restated 2020 Plan.
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
SEPTEMBER
30, 2023 AND 2022 (UNAUDITED)
General
A summary of the stock
option activity and related information for the Plans for the nine months ended September 30, 2023 is as follows:
|
|
Shares |
|
|
Weighted-
Average Exercise Price |
|
|
Weighted-
Average Remaining Contractual
Term |
|
|
Aggregate
Intrinsic
Value |
|
Outstanding at December 31, 2022 |
|
|
392,643 |
|
|
$ |
334.08 |
|
|
|
8.70 |
|
|
$ |
— |
|
Grants |
|
|
1,019,130 |
|
|
|
4.64 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
Forfeitures or expirations |
|
|
(27,509 |
) |
|
|
453.81 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2023 |
|
|
1,384,264 |
|
|
$ |
89.09 |
|
|
|
9.01 |
|
|
$ |
— |
|
Exercisable at September 30, 2023 |
|
|
248,656 |
|
|
$ |
392.48 |
|
|
|
7.78 |
|
|
$ |
|
|
The weighted average
fair value of options granted during the three and nine months ended September 2023 was $0.84 per share and $3.99 per share, respectively.
The weighted average fair value of options granted during the three and nine months ended September 2022 was $0 per share and $32.81
per share, respectively.
The Company measures
the fair value of stock options on the date of grant, based on the Black Scholes option pricing model using certain assumptions
discussed below, and the closing market price of the Company’s common stock on the date of the grant. The fair value of the
award is measured on the grant date. One-third of most stock options granted pursuant to the Plans vest 12 months from the date
of grant and 1/36th each month thereafter for 24 months and expire ten years from the date of grant. In addition, the Company issues
options to directors which vest over a period. The Company also issues premium options to executive officers which have
an exercise price greater than the grant date fair value and has issued performance-based options which vest when target parameters
are met or probable of being met, subject in each case to a one year minimum service period prior to vesting. Stock-based compensation
expense related to awards is amortized over the applicable service period using the straight-line method.
The assumptions used
in the valuation of stock options granted during the nine months ended September 30, 2023 and 2022 were as follows:
|
|
Nine Months Ended
September 30, 2023 |
|
|
Nine Months Ended
September 30, 2022 |
|
Risk-free interest rate |
|
|
3.42% to 4.35 |
% |
|
|
1.67% to 3.05 |
% |
Expected term of option |
|
|
5.0 to 10 years |
|
|
|
5.5 to 10 years |
|
Expected stock price volatility |
|
|
122.19% - 142.72 |
% |
|
|
120.32% - 133.22 |
% |
Expected dividend yield |
|
|
0.0 |
|
|
|
0.0 |
|
The risk-free interest
rate is based on the yield of Daily U.S. Treasury Yield Curve Rates with terms equal to the expected term of the options as of
the grant date. The expected term of options is determined using the simplified method, as provided in an SEC Staff Accounting
Bulletin, and the expected stock price volatility is based on the Company’ historical stock price volatility.
Stock-based compensation
expense relating to options granted of $2.1 million, of which $1.4 million and $0.7 million, related to General and Administration
and Research and Development, respectively was recognized for the quarter ended September 30, 2023. Stock-based compensation
expense relating to options granted of $2.7 million, of which $2.0 million and $0.7 million, related to General and Administration
and Research and Development, respectively was recognized for the quarter ended September 30, 2022.
Stock-based compensation
expense relating to options granted of $7.2 million, of which $5.0 million and $2.2 million, related to General and Administration
and Research and Development, respectively was recognized for the nine-month period ended September 30, 2023. Stock-based compensation
expense relating to options granted of $8.1 million, of which $5.9 million and $2.2 million, related to General and Administration
and Research and Development, respectively was recognized for the nine-month period ended September 30, 2022.
As of September 30,
2023, the Company had approximately $8.2 million of total unrecognized compensation cost related to non-vested awards granted under
the Plans, which the Company expects to recognize over a weighted average period of 1.74 years.
Employee Stock Purchase Plans
On May 6, 2022, the
Company’s stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2022 Employee Stock Purchase Plan. (the "2022 ESPP"), which was replaced by the Tonix Pharmaceuticals Holdings Corp. 2023 Employee Stock Purchase
Plan (the “2023 ESPP”, and together with the 2022 ESPP, the “ESPP Plans”), which was approved by the Company's stockholders on May 5, 2023.
The 2023 ESPP allows
eligible employees to purchase up to an aggregate of 800,000 shares of the Company’s common stock. Under the 2023
ESPP, on the first day of each offering period, each eligible employee for that offering period has the option to enroll for that
offering period, which allows the eligible employees to purchase shares of the Company’s common stock at the end of the offering
period. Each offering period under the 2023 ESPP is for six months, which can be modified from time-to-time. Subject to limitations,
each participant will be permitted to purchase a number of shares determined by dividing the employee’s accumulated
payroll deductions for the offering period by the applicable purchase price, which is equal to 85 percent of the fair
market value of our common stock at the beginning or end of each offering period, whichever is less. A participant must designate
in his or her enrollment package the percentage (if any) of compensation to be deducted during that offering period for the purchase
of stock under the 2023 ESPP, subject to the statutory limit under the Code. As of September 30, 2023, 800,000 shares were available
for future sales under the 2023 ESPP.
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
SEPTEMBER
30, 2023 AND 2022 (UNAUDITED)
The
ESPP Plans are considered compensatory plans with the related compensation cost expensed over the six-month offering period. For the
three months ended September 30, 2023 and 2022, $34,000
and $46,000,
respectively, was expensed. For the nine months ended September 30, 2023 and 2022, $34,000
and $46,000,
respectively were expensed. In January 2022, 646
shares that were purchased as of December 31, 2021, under the 2020 ESPP, were issued. Accordingly, during the first quarter of 2022,
approximately $40,000
of employee payroll deductions accumulated at December 31, 2021, related to acquiring such shares, was transferred from accrued
expenses to additional paid in capital. The remaining $30,000
was returned to the employees. In January 2023, 14,999
shares that were purchased as of December 31, 2022, under the 2022 ESPP, were issued. Accordingly, during the first quarter of 2023,
approximately $29,000
of employee payroll deductions accumulated at December 31, 2022, related to acquiring such shares, was transferred from accrued
expenses to additional paid in capital. The remaining $14,000
was returned to the employees. As of September 30, 2023, approximately $32,000
of employee payroll deductions have accumulated and have been recorded in accrued expenses.
NOTE 17 – STOCK WARRANTS
The following table
summarizes information with respect to outstanding warrants to purchase common stock of the Company at September 30, 2023:
Exercise |
|
|
Number |
|
|
Expiration |
Price |
|
|
Outstanding |
|
|
Date |
$ |
1.00 |
|
|
|
7,000,000 |
|
|
August 2028 |
$ |
100.00 |
|
|
|
125 |
|
|
November 2024 |
$ |
114.00 |
|
|
|
618 |
|
|
February 2025 |
$ |
7,000.00 |
|
|
|
2,453 |
|
|
December 2023 |
|
|
|
|
|
7,003,196 |
|
|
|
In connection with the
July 2023 Financing, the Company issued 4,470,000 prefunded warrants with an exercise price of $0.0001. All prefunded warrants were exercised during the quarter ended September 30, 2023. Additionally, the Company issued warrants to purchase up to an aggregate of 7,000,000 shares of the Company's common
stock. The warrants are exercisable at $1.00 per share, expire five years from the date of issuance.
No warrants were exercised
during either of the nine months ended September 30, 2023, and 2022.
NOTE 18 – LEASES
The Company has various
operating lease agreements, which are primarily for office space. These agreements frequently include one or more renewal options
and require the Company to pay for utilities, taxes, insurance and maintenance expense. No lease agreement imposes a restriction
on the Company’s ability to engage in financing transactions or enter into further lease agreements. At September 30, 2023,
the Company has right-of-use assets of $1.1 million and a total lease liability for operating leases of $1.1 million of which $0.7
million is included in long-term lease liabilities and $0.4 million is included in current lease liabilities.
At September 30, 2023,
future minimum lease payments for operating leases with non-cancelable terms of more than one year were as follows (in thousands):
Year Ending December 31, |
|
|
|
|
|
2023 |
|
|
$ |
107 |
|
2024 |
|
|
|
460 |
|
2025 |
|
|
|
299 |
|
2026 |
|
|
|
142 |
|
2027 and beyond |
|
|
|
246 |
|
|
|
|
|
1,254 |
|
Included interest |
|
|
|
(104 |
) |
|
|
|
$ |
1,150 |
|
During the nine months
ended September 30, 2023, the Company entered into new operating leases and lease amendments, resulting in the Company recognizing
an additional operating lease liability of approximately $898,000 based on the present value of the minimum rental payments. The
Company also recognized a corresponding increase to ROU assets of approximately $898,000, which represents a non-cash operating activity.
During the nine months
ended September 30, 2022, the Company entered into new operating leases and lease amendments, resulting in the Company recognizing
an additional operating lease liability of approximately $386,000 based on the present value of the minimum rental payments. The
Company also recognized a corresponding increase to ROU assets of approximately $386,000, which represents a non-cash operating activity.
Other information related to leases is as follows:
Operating lease expense
was $0.1 million for both three months ended September 30, 2023 and 2022.
Operating lease expense
was $0.4 million for both the nine-months ended September 30, 2023 and 2022.
Other information related to leases is as follows:
Cash paid for amounts included in the measurement of lease liabilities: |
|
Nine
Months Ended
September 30, 2023 |
|
|
Nine
Months Ended
September 30, 2022 |
|
Operating cash flow from operating leases (in thousands) |
|
$ |
434 |
|
|
$ |
447 |
|
|
|
|
|
|
|
|
|
|
Weighted Average Remaining Lease Term |
|
|
|
|
|
|
|
|
Operating leases |
|
|
3.50 years |
|
|
|
2.33 years |
|
|
|
|
|
|
|
|
|
|
Weighted Average Discount Rate |
|
|
|
|
|
|
|
|
Operating leases |
|
|
4.63 |
% |
|
|
2.26 |
% |
TONIX
PHARMACEUTICALS HOLDING CORP.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
SEPTEMBER
30, 2023 AND 2022 (UNAUDITED)
NOTE 19 – COMMITMENTS
Contractual agreements
The Company has entered
into contracts with various contract research organizations with outstanding commitments aggregating approximately $33.4 million
at September 30, 2023 for future work to be performed.
Defined contribution plan
The Company has a qualified
defined contribution plan (the “401(k) Plan”) pursuant to Section 401(k) of the Code, whereby all eligible employees
may participate. Participants may elect to defer a percentage of their annual pretax compensation to the 401(k) Plan, subject
to defined limitations. The Company is required to make contributions to the 401(k) Plan equal to 100 percent of each participant’s
pretax contributions of up to six percent of his or her eligible compensation, and the Company is also required to make a contribution
equal to three percent of each participant’s salary, on an annual basis, subject to limitations under the Code. The Company
charged operations $200,000 and $700,000 for the three and nine months ended September 30, 2023, respectively, and $122,000 and
$428,000 for the three and nine months ended September 30, 2022, respectively, for contributions under the 401(k) Plan.
NOTE 20 – SUBSEQUENT EVENTS
On
September 28, 2023, the Company sold 4,050,000
shares of common stock; pre-funded warrants to purchase up to 4,950,000
shares of common stock, and accompanying Series A warrants to purchase up to 9,000,000
shares of common stock with an exercise price of $0.50
per share and expiring five
years from date of issuance, and Series B warrants to purchase up to 9,000,000
shares of common stock with an exercise price of $0.50
per share and expiring one
year from date of issuance in a public offering, which closed on October 3, 2023. The offering price per share of common
stock and accompanying warrants was $0.50,
and the offering price per share of pre-funded warrant and accompanying warrants was $0.4999.
The Company incurred offering expenses of approximately $0.5 million, including placement agent fees of approximately
$0.3 million. The Company received net proceeds of approximately $4.0 million, after deducting the underwriting discount and other
offering expenses.
On
October 17, 2023, the Company received a letter from the Listing Qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”)
indicating that, the Company no longer met the requirement to maintain a minimum bid price of $1
per share, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).
In
accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided a period of 180
calendar days, or until April 14, 2024, in which to regain compliance with the Minimum Bid Price Requirement. In the event that the Company does not regain compliance
within this 180-day
period, the Company may be eligible to seek an additional compliance period of 180
calendar days if it meets the continued listing requirement for market value of publicly held shares and all other initial listing
standards for the Nasdaq Global Market, with the exception of the Minimum Bid Price Requirement, and provides written notice to Nasdaq
of its intent to cure the deficiency during this second compliance period, by effecting a reverse stock split, if necessary. However,
if it appears to the Nasdaq Staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible,
Nasdaq will provide notice to the Company that its common stock will be subject to delisting.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This
Management’s Discussion and Analysis of Financial Condition and Results of Operations includes a number of forward-looking statements
that reflect Management’s current views with respect to future events and financial performance. You can identify these statements
by forward-looking words such as “may” “will,” “expect,” “anticipate,” “believe,”
“estimate” “continue,” or similar words. Those statements include statements regarding the intent, belief
or current expectations of us and members of its management team as well as the assumptions on which such statements are based. Prospective
investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risk and uncertainties,
and that actual results may differ materially from those contemplated by such forward-looking statements.
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 Securities
and Exchange Commission. Important factors known to us could cause actual results to differ materially from those
in forward-looking statements. 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. We believe that its 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 its assumptions. Factors that could cause
differences include, but are not limited to: risks related to our ability to successfully commercialize our products, failure to
obtain clearances or approvals from the United States Food and Drug Administration, or FDA, and noncompliance with FDA regulations;
our need for additional financing; substantial competition; uncertainties of patent protection and litigation; uncertainties of
government or third party payor reimbursement; limited research and development efforts and dependence upon third parties and those
discussed in the section titled “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended
December 31, 2022 and in our other SEC filings, as may be amended, supplemented or superseded from time to time by other reports
we file with the SEC.
Business
Overview
Tonix
is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent
human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets
Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a
transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace
SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s
development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product
candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic,
psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual
tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory
Phase 3 study in the third quarter of 2023, with topline data expected in late December 2023. TNX-102 SL is also being developed to
treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results were reported in the third quarter
of 2023. TNX-1900 (intranasal potentiated oxytocin), is in development as a
preventive treatment in chronic migraine, and the clinical phase of a Phase 2 proof-of-concept study is now completed with topline
data expected in early December 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety
disorder by academic collaborators under investigator-initiated INDs. TNX-1300 (cocaine esterase) is a biologic designed to treat
cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be
initiated in the fourth quarter of 2023. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated
oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s
immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including
TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of
allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of
2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801
also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including
TNX-1800, in development as a vaccine to protect against COVID-19. In the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes
TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.
*Tonix’s
product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Results
of Operations
We
anticipate that our results of operations will fluctuate for the foreseeable future due to several factors, such as the progress of our
research and development efforts and the timing and outcome of regulatory submissions. Due to these uncertainties, accurate predictions
of future operations are difficult or impossible to make.
Three
Months Ended September 30, 2023 Compared to Three Months Ended September 30, 2022
Revenues. The
Company recognized revenue from customers beginning in the three months period ended September 30, 2023 as a result of the Upsher
Smith acquisition. See discussion at Note 10 to our interim condensed financial statements appearing in this Quarterly Report on
Form 10-Q. Revenue recognized for the three months ended September 30, 2023 was $4.0 million.
The
Company’s net product revenues are summarized below:
| |
Three Months Ended September 30, |
| |
2023 | | |
2022 |
Zembrace® Symtouch® | |
$ | 3,292 | | |
$ | — |
Tosymra® | |
| 697 | | |
$ | — |
Total product revenues | |
$ | 3,989 | | |
$ | — |
Cost of Sales. The
Company recognized cost of sales beginning in the three months period ended September 30, 2023 as a result of the Upsher Smith
acquisition. See discussion at Note 10 to our interim condensed financial statements appearing in this Quarterly Report on Form
10-Q. Cost of sales recognized for the three months ended September 30, 2023 was $2.4 million.
Research
and Development Expenses. Research and development expenses for the three months ended September 30, 2023 were $21.1 million,
a decrease of $1.1 million, or 5%, from $22.2 million for the three months ended September 30, 2022. This decrease is predominately due
to decreased non-clinical expenses of $1.6 million, manufacturing expenses of $2.9 million, offset by an increase in clinical expenses
of $1.5 million, an increase in employee-related expenses and professional fees of $1.0 million, office-related expenses of $0.7 million
and lab supplies of $0.2 million.
The
table below summarizes our direct research and development expenses for our product candidates and development platform for the three
months ended September 30, 2023, and 2022.
| |
Three months ended September 30, |
| |
(in thousands) |
| |
2023 | |
2022 | |
Change |
Research and development expenses: | |
| |
| |
|
Direct expenses – TNX - 102 SL | |
$ | 3,365 | | |
$ | 4,258 | | |
$ | (893 | ) |
Direct expenses – TNX - 601 ER | |
| 2,901 | | |
| 207 | | |
| 2,694 | |
Direct expenses – TNX - 801 | |
| 551 | | |
| 1,281 | | |
| (730 | ) |
Direct expenses – TNX - 1500 | |
| 2,420 | | |
| 4,219 | | |
| (1,799 | ) |
Direct expenses – TNX - 1900 | |
| 627 | | |
| 1,116 | | |
| (489 | ) |
Direct expenses – Other programs | |
| 6,127 | | |
| 3,279 | | |
| 2,848 | |
Internal staffing, overhead and other | |
| 5,059 | | |
| 7,841 | | |
| (2,782 | ) |
Total research & development | |
$ | 21,050 | | |
$ | 22,201 | | |
$ | (1,151 | ) |
Our direct research
and development expenses consist principally of external costs for clinical, nonclinical and manufacturing, such as fees paid to
contractors, consultants and contract research organizations in connection with our development work. Included in “Internal
Staffing, Overhead and Other” is overhead, supplies, research and development employee costs (including stock option expenses),
travel, regulatory and legal.
General
and Administrative Expenses. General and administrative expenses for the three months ended September 30, 2023 were
$8.7 million, an increase of $1.3 million, or 18%, from $7.4 million incurred in the three months ended September 30, 2022. The
increase is primarily due to sales and marketing of $1.3 million, transition services agreement fees payable to Upsher-Smith Laboratories,
LLC (“USL”) of $0.7 million, an increase in amortization expenses of $0.2 million, offset by a decrease in financial
reporting expenses of $0.6 million and payroll-related expenses of $0.4 million.
Net
Loss. As a result of the foregoing, the net loss for the three months ended September 30, 2023 was $28.0 million, compared to
a net loss of $29.0 million for the three months ended September 30, 2022.
Nine
Months Ended September 30, 2023 Compared to Nine Months Ended September 30, 2022
Revenues. The
Company recognized revenue from Customers beginning in the nine months period ended September 30, 2023 as a result of the Upsher
Smith acquisition. See discussion at Note 10 to our interim condensed financial statements appearing in this Quarterly Report on
Form 10-Q. Revenue recognized for the nine months ended September 30, 2023 was $4.0 million.
The Company’s net product revenues are summarized below:
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Zembrace® Symtouch® | |
$ | 3,292 | | |
$ | — | |
Tosymra® | |
| 697 | | |
$ | — | |
Total product revenues | |
$ | 3,989 | | |
$ | — | |
Cost of Sales. The
Company recognized cost of sales beginning in the nine months period ended September 30, 2023 as a result of the Upsher Smith acquisition.
See discussion at Note 10 to our interim condensed financial statements appearing in this Quarterly Report on Form 10-Q. Cost of
sales recognized for the nine months ended September 30, 2023 was $2.4 million
Research
and Development Expenses. Research and development expenses for the nine months ended September 30, 2023 were $69.5 million,
an increase of $12.3 million, or 22%, from $57.2 million for the nine months ended September 30, 2022. This increase is predominately
due to increased clinical expenses of $6.9 million, employee-related expenses of $3.7 million, office-related expenses of $3.5 million
and lab supplies of $2.7 million, offset by a decrease in manufacturing costs of $6.1 million and non-clinical expenses of $0.2 million.
The
table below summarizes our direct research and development expenses for our product candidates and development platform for the nine
months ended September 30, 2023, and 2022.
| |
Nine months ended September 30, (in thousands) |
| |
2023 | |
2022 | |
Change |
Research and development expenses: | |
| |
| |
|
Direct expenses – TNX - 102 SL | |
$ | 10,342 | | |
$ | 10,388 | | |
$ | (46 | ) |
Direct expenses – TNX - 601 ER | |
| 7,431 | | |
| 854 | | |
| 6,577 | |
Direct expenses – TNX - 801 | |
| 2,261 | | |
| 1,478 | | |
| 783 | |
Direct expenses – TNX - 1800 | |
| 1,576 | | |
| 3,503 | | |
| (1,927 | ) |
Direct expenses – TNX - 1500 | |
| 6,010 | | |
| 7,731 | | |
| (1,721 | ) |
Direct expenses – TNX - 1900 | |
| 4,168 | | |
| 2,669 | | |
| 1,499 | |
Direct expenses – Other programs | |
| 10,696 | | |
| 10,650 | | |
| 46 | |
Internal staffing, overhead and other | |
| 27,051 | | |
| 19,929 | | |
| 7,122 | |
Total research & development | |
$ | 69,535 | | |
$ | 57,202 | | |
$ | 12,333 | |
Our
direct research and development expenses consist principally of external costs for clinical, nonclinical and manufacturing, such as fees
paid to contractors, consultants and CROs in connection with our development work. Included in “Internal Staffing, Overhead and
Other” is overhead, supplies, research and development employee costs (including stock option expenses), travel, regulatory and
legal.
General
and Administrative Expenses. General and administrative expenses for the nine months ended September 30, 2023 were $23.1
million, an increase of $0.9 million, or 4%, from $22.2 million incurred in the nine months ended September 30, 2022. The increase is
primarily due to sales and marketing of $1.3 million, and transition services agreement fees payable to USL of $0.7 million, depreciation
expenses of $0.3 million and accounting-related expenses of $0.3 million, offset by a decrease in financial reporting expenses of $1.8
million and compensation-related expenses of $0.2 million.
Net
Loss. As a result of the foregoing, the net loss for the nine months ended September 30, 2023 was $89.3 million, compared to
a net loss of $78.5 million for the nine months ended September 30, 2022.
License
Agreements
On February 13, 2023,
we exercised an option to obtain an exclusive license from Columbia for the development of a portfolio of fully human and murine
mAbs for the treatment or prophylaxis of SARS-CoV-2 infection, including our TNX-3600 and TNX-4100 product candidates, respectively.
The licensed mAbs were developed as part of a research collaboration and option agreement between us and Columbia.
On December 12, 2022,
we entered into an exclusive license agreement with Curia for the development of three humanized murine mAbs for the treatment
or prophylaxis of SARS-CoV-2 infection. As consideration for entering into the License Agreement, we paid a license fee of approximately
$0.4 million to Curia. The license agreement also provides for single-digit royalties and contingent milestone payments. As of
September 30, 2023, other than the upfront fee, no payments have been accrued or paid in relation to this agreement.
On May 18, 2022, we
entered into an exclusive license agreement with the University of Alberta focused on identifying and testing broad-spectrum antiviral
drugs against future variants of SARS-CoV-2 and other emerging viruses. As consideration for entering into the license agreement,
we paid a low-five digit license fee to University of Alberta. The license agreement also provides for single-digit royalties and
contingent milestone payments. As of September 30, 2023, other than the upfront fee, no payments have been accrued or paid in relation
to this agreement.
Asset
Purchase Agreements
On June 23, 2023, we
entered into an asset purchase agreement with USL for the acquisition of certain assets related to Zembrace® SymTouch®
(sumatriptan injection) 3 mg (“Zembrace”) and Tosymra® (sumatriptan nasal spray) 10 mg (“Tosymra”)
products (such businesses collectively, the “Business”) and certain inventory related to the Business for an aggregate
purchase price of approximately $26.5 million, including certain deferred payments (such transaction, the “USL Acquisition”).
The transaction closed on June 30, 2023.
Additionally, in connection
with the USL Acquisition, we and USL entered into a transition services agreement pursuant to which USL will provide certain transition
services to us for base fees equal to $100,000 per month for the first six months, and $150,000 per month for the seventh through
ninth months, plus additional monthly fees for each service category totaling up to $150,000 per month.
As the assets acquired
met the definition of a business under the current accounting guidance, the total purchase price was allocated to the acquired
inventory and other tangible assets, and the developed technology intangible assets related to Zembrace and Tosymra based on their
estimated fair values on the acquisition date. The excess of the purchase price over the fair value of the acquired assets was
recorded as goodwill.
We
have assumed certain obligations of USL, including the payment of quarterly earn-out payments on annual net sales from the Business
in the U.S. as follows: for Tosymra, 4% for net sales of $0 to $30 million, 7% of net sales of $30 to $75 million; 9% for net sales
of $75 to $100 million; 12% for net sales of $100 to $150 million; and 15% for net sales greater than $150 million. Earn-out payments
with respect to Tosymra are payable until the expiration or termination of the product’s Orange Book listed patent(s) with
respect to the United States or, outside the United States, the expiration of the last valid claim covering the product in the
relevant country of the territory. For Zembrace, earn-out payments on annual net sales in the U.S. are 3% for net sales of $0 to
$30 million, 6% of net sales of $30 to $75 million; 12% for net sales of $75 to $100 million; 16% for net sales of greater than
$100 million. Such earn-out payments are payable until July 19, 2025. Upon the entry of a generic version of the relevant product,
the applicable earn-out rates shall be reduced by 90% percent with respect to Zembrace, and by 66.7% percent for Tosymra.
In
addition, we have assumed the obligation to pay an additional 3% royalty on net sales of Tosymra, plus an additional 3% if a patent
containing certain claims related to Tosymra issues in the U.S., for 15 years from the first commercial sale of Tosymra in the
applicable country or for as long as the manufacture, use or sale of Tosymra in such country is covered by a valid claim of a licensed
patent, and up to $15 million per Tosymra product on the achievement of sales milestones.
On
February 2, 2023, we entered into an asset purchase agreement (the “Healion Purchase Agreement”) with Healion
Bio Inc., pursuant to which we acquired all the pre-clinical infectious disease assets of
Healion. As consideration for entering into the Healion Purchase Agreement, we paid $1.2 million to Healion. Because the
Healion intellectual property was acquired prior to FDA approval, the cash consideration totaling $1.2 million, was expensed as
research and development costs since there is no alternative future use and the acquired intellectual property does not constitute
a business.
Liquidity
and Capital Resources
As
of September 30, 2023, we had working capital of $13.6 million, comprised primarily of cash and cash equivalents of $6.9 million, inventory
of $13.3 million, receivables, net of $1.6 million and prepaid expenses and other of $9.5 million, offset by $7.8 million of accounts payable, $9.5 million of accrued
expenses and current lease liabilities of $0.4 million. A significant portion of the accounts payable and accrued expenses are due to
work performed in relation to our clinical programs, and the USL Acquisition.
The
following table provides a summary of operating, investing and financing cash flows for the nine months ended September 30, 2023, and
2022, respectively (in thousands):
| |
September 30, | |
| |
2023 | | |
2022 | |
Net cash used in operating activities | |
$ | (79,663 | ) | |
$ | (75,752 | ) |
Net cash used in investing activities | |
| (28,639 | ) | |
| (43,476 | ) |
Net cash (used in) provided by financing activities | |
| (4,198 | ) | |
| 80,615 | |
For
the nine months ended September 2023 and 2022, we used approximately $79.7 million and $75.8 million of cash in operating activities,
respectively, which represents cash outlays for research and development and general and administrative expenses in such periods. The
increase in cash outlays principally resulted from an increase in both research and development and general and administrative activities.
For the nine months ended September 30, 2023, net cash used from financing activities was $4.2 million predominately from the repurchase
of common stock. For the nine months ended September 30, 2022, net proceeds in financing activities was $80.6 million, predominately
from the sale of our common and preferred stock. Cash used in investing activities for the nine months ended September 30, 2023 was $28.6
related to the purchase of the USL assets and property and equipment, and $43.5 million for the nine months ended September 30, 2022
related to the purchase of property and equipment.
We
believe that our cash resources at September 30, 2023, and the proceeds that we raised from equity offerings subsequent to the end
of the third quarter of 2023 will not meet our operating and capital expenditure requirements through the fourth quarter of 2023.
We continue to face significant challenges and uncertainties and, as a
result, our available capital resources may be consumed more rapidly than currently expected due to changes we may make in our research
and development spending plans. These factors raise substantial doubt about our ability to continue as a going concern for the one year
period from the date of filing of this Form 10-Q. We must obtain additional funding through public or private financing or collaborative
arrangements with strategic partners to increase the funds available to fund operations. Without additional funds, we may be forced to
delay, scale back or eliminate some of our research and development activities, or other operations and potentially delay product development
in an effort to provide sufficient funds to continue our operations. If any of these events occurs, our ability to achieve our development
and commercialization goals would be adversely affected and we may be forced to cease operations.
Future
Liquidity Requirements
We
expect to incur losses from operations for the near future. We expect to incur increasing research and development expenses, including
expenses related to additional clinical trials and the buildout of our research and development operations and manufacturing. We will
not have enough resources to meet our operating requirements for the one-year period from filing date of this report.
Our
future capital requirements will depend on a number of factors, including the progress of our research and development of product candidates,
the timing and outcome of regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing
patent claims and other intellectual property rights, the status of competitive products, the availability of financing and our success
in developing markets for our product candidates.
We
will need to obtain additional capital in order to fund future research and development activities and future capital expenditures. Future
financing may include the issuance of equity or debt securities, obtaining credit facilities, or other financing mechanisms. Even if
we are able to raise the funds required, it is possible that we could incur unexpected costs and expenses, fail to collect significant
amounts owed to us, or experience unexpected cash requirements that would force us to seek alternative financing. Furthermore, if we
issue additional equity or debt securities, shareholders may experience additional dilution or the new equity securities may have rights,
preferences or privileges senior to those of existing holders of our common stock.
If
additional financing is not available or is not available on acceptable terms, we may be required to delay, reduce the scope of or eliminate
our research and development programs, reduce our commercialization efforts or obtain funds through arrangements with collaborative partners
or others that may require us to relinquish rights to certain product candidates that we might otherwise seek to develop or commercialize
independently.
Share
Repurchase Program
During the first quarter of 2023,
we repurchased 2,512,044 of our shares of common stock outstanding under the 2022 share repurchase program for up to $12.5 million at
prices ranging from $2.75 to $8.61 per share for a gross aggregate cost of approximately $12.5 million. In addition, we incurred
expenses of $0.3 million.
In
January 2023, the Board of Directors approved a new 2023 share repurchase program pursuant
to which we may repurchase up to an additional $12.5 million in value of our outstanding common stock from time to time on
the open market and in privately negotiated transactions subject to market conditions, share price and other factors. During
the first quarter of 2023, we repurchased 160,000 of our shares of common stock outstanding
under the new 2023 share repurchase program at $7.12 per share for a gross aggregate cost of $1.1 million. No share repurchases occurred in the third quarter of 2023.
Convertible
Redeemable Preferred stock
On
October 26, 2022, we issued 1,400,000 shares of Series A Preferred Stock and 100,000 shares of Series B Preferred Stock to certain
institutional investors in a private placement. The Preferred Stock had an aggregate stated value of $15,000,000. Each share of
the Preferred Stock had a purchase price of $9.50, representing an OID of 5% of the stated value. The shares of the preferred stock
were convertible into shares of our common stock, upon the occurrence of certain events, at a conversion price of $6.25 per share.
All
outstanding shares of the Series A Convertible Redeemable Preferred Stock and Series B Convertible Redeemable Preferred Stock were redeemed
in December 2022 at 105% of the $10.00 stated value of the Preferred Stock, or $15.8 million in the aggregate.
On
June 24, 2022, we issued 2,500,000 shares of Series A Preferred Stock and 500,000 shares of Series B Preferred Stock to certain
institutional investors in a private placement. The Preferred Stock had an aggregate stated value of $30,000,000. Each share of
the Preferred Stock had a purchase price of $9.50, representing an OID of 5% of the stated value. The shares of the preferred stock
were convertible into shares of our common stock, upon the occurrence of certain events, at a conversion price of $25.00 per share.
All
outstanding shares of the Series A Convertible Redeemable Preferred Stock and Series B Convertible Redeemable Preferred Stock were redeemed
in August 2022 at 105% of the $10.00 stated value of the Preferred Stock, or $31.5 million in the aggregate.
September
2023 Financing
On
September 28, 2023, we sold 4,050,000 shares of common stock; pre-funded warrants
to purchase up to 4,950,000 shares of common stock, and accompanying common warrants to purchase up to 9,000,000 shares of common stock
with an exercise price of $0.50 per share and expiring one year from date of issuance, and common warrants to purchase up to 9,000,000
shares of common stock with an exercise price of $0.50 per share and expiring five years from date of issuance in a public offering which closed on October 3, 2023. The offering price per
share of common stock and accompanying common warrant was $0.50, and the offering price per share of pre-funded warrant and accompanying
common warrant was $0.4999.
We incurred other offering expenses of approximately $0.5 million, which included a placement agent discount. We received net proceeds
of approximately $4.0 million, after deducting the underwriting discount and other offering expenses.
July
2023 Financing
On
July 27, 2023, we sold securities consisting of 2,530,000 shares of common stock; pre-funded warrants to purchase up to 4,470,000 shares of common stock
and common warrants to purchase up to 7,000,000 shares of common stock in a public offering that closed on August 1, 2023. The offering price per Share and accompanying Common Warrant
is $1.00, and the offering price per Pre-Funded Warrant and accompanying Common Warrant is $0.9999.
We incurred other offering expenses of approximately $0.7 million, which included a placement agent discount. We received
net proceeds of approximately $6.3 million, after deducting the underwriting discount and other offering expenses.
2022
Lincoln Park Transaction
On August 16, 2022,
we entered into a purchase agreement (the “2022 Purchase Agreement”) and a registration rights agreement with Lincoln
Park, pursuant to which Lincoln Park agreed to purchase from us up to $50,000,000 of our common stock (subject to certain limitations)
from time to time. We filed a registration statement to register for resale the shares that have been or may be issued to Lincoln
Park under the 2022 Purchase Agreement.
We issued 100,000 shares
of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock under the 2022 Purchase
Agreement. The commitment shares were valued at $1,000,000 and recorded as an addition to equity for the issuance of the common
stock and treated as a reduction to equity as a cost of capital to be raised under the 2022 Purchase Agreement.
During
the three and nine months ended September 30, 2023, we sold 0 and 0.1 million shares, respectively, of common stock under the 2022 Purchase
Agreement, for net proceeds of approximately $0 and $0.4 million, respectively. During the nine months ended September 30, 2022,
no shares of common stock were sold under the 2022 Purchase Agreement.
2021 Lincoln Park Transaction
On December 3, 2021,
we entered into a purchase agreement (the “2021 Purchase Agreement”) and a registration rights agreement with Lincoln
Park, pursuant to which Lincoln Park has agreed to purchase from us up to $80,000,000 of our common stock (subject to certain limitations)
from time to time. We filed a registration statement to register for resale the shares that have been or may be issued to Lincoln
Park under the 2021 Purchase Agreement.
We issued 14,546 shares
of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock under the 2021 Purchase
Agreement with Lincoln Park. The commitment shares were valued at $1.6 million and recorded as an addition to equity for the issuance
of the common stock and treated as a reduction to equity as a cost of capital to be raised under the Purchase Agreement with Lincoln
Park.
During the nine months
ended September 30, 2022, we sold 0.5 million shares of common stock under the 2021 Purchase Agreement with Lincoln Park, for net
proceeds of approximately $8.7 million. No sales occurred in 2023, and we may not sell any additional shares under the 2021 Purchase
Agreement.
At-the-Market
Offerings
On
April 8, 2020, we entered into a sales agreement (the “Sales Agreement”) with AGP pursuant to which we may issue and sell,
from time to time, shares of our common stock having an aggregate offering price of up to $320.0 million in at-the-market offerings (“ATM”)
sales. AGP will act as sales agent and will be paid a 3% commission on each sale under the Sales Agreement. Our common stock will be
sold at prevailing market prices at the time of the sale, and, as a result, prices will vary. During the three and nine months ended
September 30, 2023, we sold approximately 0 million and 1.0 million shares, respectively, of common stock under the Sales Agreement,
for net proceeds of approximately $0 million and $3.0 million, respectively. During the three and nine months ended September 30, 2022,
we sold approximately 3.1 million and 5.5 million shares, respectively, of common stock under the Sales Agreement, for net proceeds of
approximately $43.0 million and $76.2 million, respectively.
Stock
Compensation
On
May 1, 2020, our stockholders approved the Tonix Pharmaceuticals Holding Corp. Amended and Restated 2020 Stock Incentive Plan (“Amended
and Restated 2020 Plan”).
Under the terms of
the Amended and Restated 2020 Plan, we may issue (1) stock options (incentive and nonstatutory), (2) restricted stock, (3) stock
appreciation rights (“SARs”), (4) restricted stock units, (5) other stock-based awards, and (6) cash-based awards.
The Amended and Restated 2020 Plan initially provided for the issuance of up to 50,000 shares of common stock, which amount will
be increased to the extent that awards granted under the Plans are forfeited, expire or are settled for cash (except as otherwise
provided in the Amended and Restated 2020 Plan). In addition, the Amended and Restated 2020 Plan contains an “evergreen provision”
providing for an annual increase in the number of shares of our common stock available for issuance under the Amended and Restated
2020 Plan on January 1 of each year for a period of ten years, commencing on January 1, 2021 and ending on (and including) January
1, 2030, in an amount equal to the difference between (x) twenty percent (20%) of the total number of shares of common stock outstanding
on December 31st of the preceding calendar year, and (y) the total number of shares of common stock reserved under the
Amended and Restated 2020 Plan on December 31st of such preceding calendar year (including shares subject to outstanding
awards, issued pursuant to awards or available for future awards). The Board of Directors determines the exercise price, vesting
and expiration period of the grants under the Amended and Restated 2020 Plan. However, the exercise price of an incentive stock
option may not be less than 110% of fair value of the common stock at the date of the grant for a 10% or more shareholder and 100%
of fair value for a grantee who is not a 10% shareholder. The fair value of the common stock is determined based on quoted market
price or in absence of such quoted market price, by the Board of Directors in good faith. Additionally, the expiration period of
grants under the Amended and Restated 2020 Plan may not be more than ten years. As of September 30, 2023, 1,062,874 options were
available for future grants under the Amended and Restated 2020 Plan.
We
measure the fair value of stock options on the date of grant, based on the Black Scholes option pricing model using certain assumptions
discussed below, and the closing market price of the Company’s common stock on the date of the grant. The fair value of the award
is measured on the grant date. One-third of most stock options granted pursuant to the Plans vest 12 months from the date of grant and
1/36th each month thereafter for 24 months and expire ten years from the date of grant. In addition, the Company issues options
to directors which vest over a one-year period. The Company also issues premium options to executive officers which have an exercise
price greater than the grant date fair value and has issued performance-based options which vest when target parameters are met or probable
of being met, subject in each case to a one year minimum service period prior to vesting. Stock-based compensation expense related to
awards is amortized over the applicable service period using the straight-line method.
The
risk-free interest rate is based on the yield of Daily U.S. Treasury Yield Curve Rates with terms equal to the expected term of the options
as of the grant date. The expected term of options is determined using the simplified method, as provided in an SEC Staff Accounting
Bulletin, and the expected stock price volatility is based on the Company’ historical stock price volatility.
The
weighted average fair value of options granted during the three and nine months ended September 30, 2023 was $0.84 per share and $3.99
per share, respectively. The weighted average fair value of options granted during the three and nine months ended September 30, 2022
was $0 per share and $32.81 per share, respectively.
Stock-based
compensation expense relating to options granted of $2.1 million, of which $1.4 million and $0.7 million, related to General and Administration
and Research and Development, respectively was recognized for the quarter ended September 30, 2023. Stock-based compensation expense
relating to options granted of $2.7 million, of which $2.0 million and $0.7 million, related to General and Administration and Research
and Development, respectively was recognized for the quarter ended September 30, 2022.
Stock-based
compensation expense relating to options granted of $7.2 million, of which $5.0 million and $2.2 million, related to General and Administration
and Research and Development, respectively was recognized for the nine-month period ended September 30, 2023. Stock-based compensation
expense relating to options granted of $8.1 million, of which $5.9 million and $2.2 million, related to General and Administration and
Research and Development, respectively was recognized for the nine-month period ended September 30, 2022.
As
of September 30, 2023, the Company had approximately $8.2 million of total unrecognized compensation cost related to non-vested awards
granted under the Plans, which the Company expects to recognize over a weighted average period of 1.74 years.
Employee
Stock Purchase Plan
On May 6, 2022, our stockholders approved
the Tonix Pharmaceuticals Holdings Corp. 2022 Employee Stock Purchase Plan (the “2022 ESPP”), which was replaced by the Tonix
Pharmaceuticals Holdings Corp. 2023 Employee Stock Purchase Plan (the “2023 ESPP”, and together with the 2022 ESPP, the “ESPP
Plans”), which was approved by the Company’s stockholders on May 5, 2023.
The
2023 ESPP allows eligible employees to purchase up to an aggregate of 800,000 shares of the Company’s common stock. Under
the 2023 ESPP, on the first day of each offering period, each eligible employee for that offering period has the option to enroll for
that offering period, which allows the eligible employees to purchase shares of the Company’s common stock at the end of the offering
period. Each offering period under the 2023 ESPP is for six months, which can be modified from time-to-time. Subject to limitations,
each participant will be permitted to purchase a number of shares determined by dividing the employee’s accumulated payroll
deductions for the offering period by the applicable purchase price, which is equal to 85 percent of the fair market value
of our common stock at the beginning or end of each offering period, whichever is less. A participant must designate in his or her enrollment
package the percentage (if any) of compensation to be deducted during that offering period for the purchase of stock under the 2023 ESPP,
subject to the statutory limit under the Code. As of September 30, 2023, 800,000 shares were available for future sales under the 2023
ESPP.
The
ESPP Plans are considered compensatory plans with the related compensation cost expensed over the six-month offering period.
For the three months ended September 30, 2023 and 2022, $34,000 and $46,000, respectively, was expensed. For the nine months ended September
30, 2023 and 2022, $34,000 and $46,000, respectively were expensed. In January 2022, 646 shares that were purchased as of December 31,
2021, under the 2020 ESPP, were issued. Accordingly, during the first quarter of 2022, approximately $40,000 of employee payroll deductions
accumulated at December 31, 2021, related to acquiring such shares, was transferred from accrued expenses to additional paid in capital.
The remaining $30,000 was returned to the employees. In January 2023, 14,999 shares that were purchased as of December 31, 2022, under
the 2022 ESPP, were issued. Accordingly, during the first quarter of 2023, approximately $29,000 of employee payroll deductions accumulated
at December 31, 2022, related to acquiring such shares, was transferred from accrued expenses to additional paid in capital. The remaining
$14,000 was returned to the employees. As of September 30, 2023, approximately $32,000 of employee payroll deductions have accumulated
and have been recorded in accrued expenses.
Commitments
Research
and Development Contracts
We
have entered into contracts with various contract research organizations with outstanding commitments aggregating approximately $33.4
million at September 30, 2023 for future work to be performed.
Operating
leases
As
of September 30, 2023, future minimum lease payments are as follows (in thousands):
Year Ending
December 31, |
|
|
|
|
2023 |
|
|
$ |
107 |
|
2024 |
|
|
|
460 |
|
2025 |
|
|
|
299 |
|
2026 |
|
|
|
142 |
|
2027 and beyond |
|
|
|
246 |
|
Included interest |
|
|
|
(104 |
) |
|
|
|
$ |
1,150 |
|
Critical
Accounting Policies and Estimates
Our
discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements,
which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial
statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. We evaluate
our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on assumptions that we believe to
be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and
liabilities that are not readily apparent from other sources. Actual results may differ from these estimates.
We
believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our
condensed consolidated financial statements.
Business
Combinations. We apply the acquisition method of accounting for business combinations. Under the acquisition method, the acquiring entity
recognizes all of the identifiable assets acquired and liabilities assumed at their acquisition date fair values. We use our best estimates
and assumptions to estimate the fair values of these tangible and intangible assets. Any excess of the purchase price over amounts allocated
to the assets acquired is recorded as goodwill. The acquired intangible assets are amortized using the straight-line method over the
estimated useful lives of the respective assets. Goodwill is reviewed for impairment on an annual basis, or more frequently if events
or changes in circumstances indicate that the carrying amount of goodwill may be impaired.
Revenue
Recognition. Our gross product revenues are subject to a variety of deductions, which generally are estimated and recorded in the same
period that the revenues are recognized. Such variable consideration represents chargebacks, rebates, prompt pay and other sales discounts,
and product returns. These deductions represent estimates of the related obligations and, as such, knowledge and judgment are required
when estimating the impact of these revenue deductions on gross sales for a reporting period. We began recognizing revenue following
the completion of the USL Acquisition, beginning in the period ended September 30, 2023, and required variable consideration estimates
are currently primarily based on the acquired products historical results. Adjustments to these estimates to reflect actual results or
updated expectations will be assessed each period. If any of our ratios, factors, assessments, experiences, or judgments are not indicative
or accurate estimates of our future experience, our results could be materially affected. The potential of our estimates to vary differs
by program, product, type of customer and geographic location. In addition, estimates associated with U.S. Medicare and Medicaid governmental
rebate programs are at risk for material adjustment because of the extensive time delay.
Research
and Development. We outsource certain of our research and development efforts and expense the related costs as incurred, including the
cost of manufacturing product for testing, licensing fees and costs associated with planning and conducting clinical trials. The value
ascribed to patents and other intellectual property acquired was expensed as research and development costs, as it related to particular
research and development projects and had no alternative future uses.
We
estimate our accrued expenses. Our clinical trial accrual process is designed to account for expenses resulting from our obligations
under contracts with vendors, consultants and clinical research organizations and clinical site agreements in connection with conducting
clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result
in payment flows that do not match the periods over which materials or services are provided to us under such contracts. We account for
trial expenses according to the progress of the trial as measured by participant progression and the timing of various aspects of the
trial. We determine accrual estimates that take into account discussions with applicable personnel and outside service providers as to
the progress or state of completion of trials, or the services completed. During the course of a clinical trial, we adjust our clinical
expense recognition if actual results differ from our estimates. We make estimates of our accrued expenses as of each balance sheet date
based on the facts and circumstances known to us at that time. Our clinical trial accruals and prepaid assets are dependent upon the
timely and accurate reporting of contract research organizations and other third-party vendors.
Stock-Based
Compensation. All stock-based payments to employees and to nonemployee directors for their services as directors consisted of grants
of restricted stock and stock options, which are measured at fair value on the grant date and recognized in the consolidated statements
of operations as compensation expense over the relevant vesting period. In addition, for awards that vest immediately and are nonforfeitable,
the measurement date is the date the award is issued.
Redeemable
Convertible Preferred Stock. Preferred shares subject to mandatory redemption are classified as liability instruments and are measured
at fair value. The Company classifies conditionally redeemable preferred shares, which includes preferred shares that feature redemption
rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within
the Company’s control, as temporary equity (“mezzanine”) until such time as the conditions are removed or lapse.
Other
than contractual obligations incurred in the normal course of business, we do not have any off-balance sheet financing arrangements or
liabilities, guarantee contracts, retain or contingent interests in transferred assets or any obligation arising out of a material variable
interest in an unconsolidated entity.
Recently
Adopted Accounting Pronouncements
In
August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives
and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an
Entity’s Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under
current GAAP. The ASU also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative
scope exception, and it also simplifies the diluted earnings per share calculation in certain areas. We adopted ASU 2020-06 on January
1, 2023, under the modified retrospective method of transition. The adoption of ASU 2020-06 did not impact the Company’s financial
position, results of operations or cash flows.
In
June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments. The main objective of ASU 2016-13
is to provide financial statement users with more decision-useful information about an entity's expected credit losses on financial instruments
and other commitments to extend credit at each reporting date. To achieve this objective, the amendments in this update replace the incurred
loss impairment methodology currently used today with a methodology that reflects expected credit losses and requires consideration of
a broader range of reasonable and supportable information to develop credit loss estimates. ASU 2016-13 will be effective for
us for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years, using a modified retrospective
approach. Early adoption is permitted. We adopted ASU 2016-13 and related updates as of January 1, 2023. The adoption
of ASU 2016-13 did not impact the Company’s financial position, results of operations or cash flows.
ITEM
3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
applicable.
ITEM
4 – CONTROLS AND PROCEDURES
Evaluation
of disclosure controls and procedures.
Our
management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure
controls and procedures pursuant to Rule 13a-15 under the Securities Exchange Act of 1934 as of the end of the period covered by this
Quarterly Report on Form 10-Q. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls
and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives.
In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management
is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Based
on our evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of September 30, 2023, our disclosure controls
and procedures are designed at a reasonable assurance level and are effective to provide reasonable assurance that information we are
required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within
the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including
our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes
in internal control over financial reporting.
The acquisition of marketed products from USL has had a material impact
on the Company’s internal control over financial reporting as we are now required and have implemented controls related to revenue
and inventory management. Management established controls to mitigate the risk over financial reporting as it relates to the services
provided by USL under the transition services agreement.
Except as otherwise described above, there was no change in our internal
control over financial reporting that occurred during the third quarter of 2023 that has materially affected, or is reasonably likely
to materially affect, our internal control over financial reporting.
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings
We
are currently not a party to any material legal proceedings or claims.
Item
1A. Risk Factors
Except as set forth
below, there were no material changes from the risk factors set forth under Part I, Item 1A., “Risk Factors” in our
Annual Report on Form 10-K for the fiscal year ended December 31, 2022. You should carefully consider the risk factors set forth
in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as well as other reports and statements that we
file and have filed with the SEC, in addition to the other information set forth in this report which could materially affect our
business, financial condition or future results. The risks and uncertainties described in this report and in our Annual Report
on Form 10-K for the year ended December 31, 2022, as well as other reports and statements that we file with the SEC, are not the
only risks and uncertainties facing us. Additional risks and uncertainties not currently known to us or that we currently deem
to be immaterial may also have a material adverse effect on our financial position, results of operations or cash flows.
We could
be delisted from Nasdaq, which could seriously harm the liquidity of our stock and our ability to raise capital.
We
have had in the past, and may in the future, have difficulty satisfying Nasdaq listing requirements for our common stock. We are
currently not in compliance with Nasdaq listing requirements, specifically the minimum bid price requirement, and must regain compliance
prior to April 15, 2024. If we are unable to regain such compliance, we will cease to be eligible to trade on Nasdaq. In such event:
| ● | We may have to pursue trading on a less recognized or accepted market, such as the OTC Bulletin
Board or the “pink sheets.” |
| ● | Shares of our common stock could be less liquid and marketable, thereby reducing the ability of
stockholders to purchase or sell our shares as quickly and as inexpensively as they have done historically. If our stock is traded
as a “penny stock,” transactions in our stock would be more difficult and cumbersome. |
| ● | We may be unable to access capital on favorable terms or at all, as companies trading on alternative
markets may be viewed as less attractive investments with higher associated risks, such that existing or prospective institutional
investors may be less interested in, or prohibited from, investing in our common stock. This may also cause the market price of
our common stock to decline. |
Item 2. Unregistered Sales of Equity
Securities, Use of Proceeds, and Issuer Purchases of Equity Securities
None.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
None.
Item
5. Other Information
None.
Item
6. Exhibits
1.01
|
Placement Agent Agreement, dated September 28, 2023, among Tonix Pharmaceuticals Holding Corp., A.G.P./Alliance
Global Partners and Brookline Capital Markets, a division of Arcadia Securities, LLC, filed as an exhibit to the Current Report
on Form 8-K, filed with the Securities and Exchange Commission (the “Commission”) on September 29, 2023 and incorporated
herein by reference |
|
|
2.01 |
Articles of
Merger between Tamandare Explorations Inc. and Tonix Pharmaceuticals Holding Corp., effective October 11, 2011, filed as an exhibit
to the Current Report on Form 8-K, filed with the Commission on October 17, 2011 and incorporated herein by reference. |
|
|
|
|
3.01 |
Articles of Incorporation, filed as an exhibit to the Registration Statement on Form S-1, filed with the
Commission on April 9, 2008 and incorporated herein by reference. |
|
|
|
|
3.02 |
Third
Amended and Restated Bylaws, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on June 3, 2016 and incorporated
herein by reference. |
|
|
3.03 |
Certificate of Change of
Tonix Pharmaceuticals Holding Corp., dated March 13, 2017 and effective March 17, 2017, filed as an exhibit to the Current Report
on Form 8-K, filed with the Commission on March 16, 2017 and incorporated herein by reference. |
|
|
|
|
3.04 |
Certificate of Amendment to Tonix Pharmaceuticals Holding Corp.’s Articles of Incorporation, effective
June 16, 2017, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on June 16, 2017 and incorporated
herein by reference. |
|
|
|
|
3.05 |
Specimen Common Stock Certificate,
filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on May 24, 2018 and incorporated herein by reference. |
|
|
|
|
3.06 |
Certificate of Amendment to Tonix Pharmaceuticals Holding Corp.’s Articles of Incorporation, effective
February 10, 2022, filed as an exhibit to the Current Report on Form 8-K filed with the Commission on February 10, 2022 and incorporated
herein by reference. |
|
|
|
|
3.07 |
Certificate of Amendment to Tonix Pharmaceuticals Holding Corp.’s Articles of Incorporation, as
amended, May 17, 2022, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on May 16, 2022 and incorporated
herein by reference. |
|
|
3.08 |
Certificate of Amendment to Tonix Pharmaceuticals Holding Corp.’s Articles of Incorporation, effective
December 13, 2022, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on December 13, 2022 and incorporated
herein by reference. |
|
|
|
|
3.09 |
Certificate of Amendment to Tonix Pharmaceuticals Holding Corp.’s Articles of Incorporation, as
amended, filed with the Commission on May 9, 2023 and incorporated herein by reference. |
|
|
|
|
4.01 |
Specimen Common Stock Certificate
of the Registrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on May 24, 2018 and incorporated
herein by reference. |
|
|
|
|
4.02 |
Description of Registrant’s
Securities, filed as an exhibit to the Annual Report on Form 10-K, filed with the Commission on March 14, 2022 and incorporated herein
by reference. |
|
|
4.03 |
Form of Common Warrant, filed as an exhibit
to the Current Report on Form 8-K, filed with the Commission on July 28, 2023 and incorporated herein by reference. |
|
|
4.04 |
Form of Pre-Funded Warrant, filed as an
exhibit to the Current Report on Form 8-K, filed with the Commission on July 28, 2023 and incorporated herein by reference.
|
|
|
4.05 |
Form of Pre-Funded Warrant, filed
as an exhibit to the Current Report on Form 8-K, filed with the Commission on September 29, 2023 and incorporated herein by reference. |
|
|
4.06 |
Form of Series A Warrant, filed as an exhibit to the Current
Report on Form 8-K, filed with the Commission on September 29, 2023 and incorporated herein by reference. |
|
|
4.07 |
Form of Series B Warrant, filed
as an exhibit to the Current Report on Form 8-K, filed with the Commission on September 29, 2023 and incorporated herein by reference. |
|
|
10.01 |
Form of Securities Purchase
Agreement, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on July 28, 2023 and incorporated
herein by reference. |
|
|
|
|
10.02 |
Form of Securities Purchase Agreement, dated September 28, 2023, among Tonix Pharmaceuticals Holding Corp. and the purchasers named therein, , filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on September 29, 2023 and incorporated herein by reference. |
|
|
31.01 |
Certification of Chief
Executive Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.* |
|
|
31.02 |
Certification of Chief
Financial Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.* |
|
|
32.01 |
Certification of Chief
Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.** |
|
|
|
|
|
|
101 INS |
XBRL Instance Document* |
|
|
|
|
101 SCH |
XBRL Taxonomy Extension
Schema Document* |
101 CAL |
XBRL Taxonomy Calculation Linkbase
Document* |
|
|
|
|
101 LAB |
XBRL Taxonomy Labels Linkbase Document* |
|
|
|
|
101 PRE |
XBRL Taxonomy Presentation Linkbase Document* |
|
|
|
|
104 |
Cover Page Interactive Data File (formatted as inline
XBRL and contained in Exhibit 101)* |
* Filed herewith.
** Furnished, not filed.
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.
|
TONIX PHARMACEUTICALS HOLDING CORP. |
|
|
Date: November 9, 2023 |
By: |
/s/ SETH
LEDERMAN |
|
|
Seth Lederman |
|
|
Chief Executive Officer (Principal Executive Officer) |
|
|
|
Date: November 9, 2023 |
By: |
/s/ BRADLEY
SAENGER |
|
|
Bradley Saenger |
|
|
Chief Financial Officer (Principal Financial Officer
and Principal Accounting Officer) |
Tonix Pharmaceuticals Holding Corp. 10-Q
Exhibit 31.01
CERTIFICATION
I, Seth Lederman, certify that:
|
1. |
I have reviewed this quarterly report on Form 10-Q of Tonix Pharmaceuticals Holding Corp.; |
|
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 (the registrant’s fourth fiscal quarter in the case of an annual report) 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. |
Date: November 9, 2023 |
|
/s/ SETH LEDERMAN |
|
Seth Lederman |
Chief Executive Officer |
Tonix Pharmaceuticals Holding Corp. 10-Q
Exhibit 31.02
CERTIFICATION
I, Bradley Saenger, certify that:
|
1. |
I have reviewed this quarterly report on Form 10-Q of Tonix Pharmaceuticals Holding Corp.; |
|
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 (the registrant’s fourth fiscal quarter in the case of an annual report) 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. |
Date: November 9, 2023 |
|
/s/ BRADLEY SAENGER |
|
Bradley Saenger |
Chief Financial Officer |
Tonix Pharmaceuticals Holding Corp. 10-Q
Exhibit 32.01
CERTIFICATIONS OF CHIEF EXECUTIVE OFFICER AND CHIEF
FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED
PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
I, Seth Lederman, certify, pursuant
to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report of Tonix Pharmaceuticals
Holding Corp. on Form 10-Q for the fiscal quarter ended September 30, 2023 fully complies with the requirements of Section 13(a) or 15(d)
of the Securities Exchange Act of 1934 and that information contained in this Quarterly Report on Form 10-Q fairly presents in all material
respects the financial condition and results of operations of Tonix Pharmaceuticals Holding Corp.
|
By: |
/s/ SETH LEDERMAN |
Date: November 9, 2023 |
Name: |
Seth Lederman |
|
Title: |
Chief Executive Officer |
I, Bradley Saenger, certify,
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report of
Tonix Pharmaceuticals Holding Corp. on Form 10-Q for the fiscal quarter ended September 30, 2023 fully complies with the requirements
of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that information contained in this Quarterly Report on Form 10-Q
fairly presents in all material respects the financial condition and results of operations of Tonix Pharmaceuticals Holding Corp.
|
By: |
/s/ BRADLEY SAENGER |
Date: November 9, 2023 |
Name: |
Bradley Saenger |
|
Title: |
Chief Financial Officer |
v3.23.3
Cover - shares
|
9 Months Ended |
|
Sep. 30, 2023 |
Nov. 09, 2023 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
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true
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false
|
|
Document Period End Date |
Sep. 30, 2023
|
|
Document Fiscal Period Focus |
Q3
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-36019
|
|
Entity Registrant Name |
TONIX
PHARMACEUTICALS HOLDING CORP.
|
|
Entity Central Index Key |
0001430306
|
|
Entity Tax Identification Number |
26-1434750
|
|
Entity Incorporation, State or Country Code |
NV
|
|
Entity Address, Address Line One |
26 Main Street
|
|
Entity Address, Address Line Two |
Suite 101
|
|
Entity Address, City or Town |
Chatham
|
|
Entity Address, State or Province |
NJ
|
|
Entity Address, Postal Zip Code |
07928
|
|
City Area Code |
(862)
|
|
Local Phone Number |
799-9155
|
|
Title of 12(b) Security |
Common
Stock
|
|
Trading Symbol |
TNXP
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
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Yes
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Non-accelerated Filer
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Entity Small Business |
true
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v3.23.3
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 6,914
|
$ 120,229
|
Inventory |
13,317
|
|
Receivables, net |
1,562
|
|
Prepaid expenses and other |
9,544
|
10,548
|
Total current assets |
31,337
|
130,777
|
Property and equipment, net |
94,866
|
93,814
|
Intangible assets, net |
9,982
|
120
|
Goodwill |
965
|
|
Operating lease right-to-use assets |
1,081
|
715
|
Other non-current assets |
1,051
|
264
|
Total assets |
139,282
|
225,690
|
Current liabilities: |
|
|
Accounts payable |
7,799
|
8,068
|
Accrued expenses and other current liabilities |
9,500
|
9,680
|
Lease liability, short term |
434
|
432
|
Total current liabilities |
17,733
|
18,180
|
Lease liability, long term |
716
|
328
|
Total liabilities |
18,449
|
18,508
|
Stockholders’ equity: |
|
|
Preferred stock, $0.001 par value; 5,000,000 shares authorized Series B Convertible Preferred stock, 0 shares designated as of both September 30, 2023 and December 31, 2022; issued and outstanding - none Series A Convertible Preferred stock, 0 shares designated as of both September 30, 2023 and December 31, 2022; issued and outstanding - none |
|
|
Common stock, $0.001 par value; 160,000,000 shares authorized; 17,762,341 and 12,368,620 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively and 14,999 shares to be issued as of December 31, 2022 |
18
|
12
|
Additional paid in capital |
694,371
|
677,375
|
Accumulated deficit |
(573,336)
|
(470,038)
|
Accumulated other comprehensive loss |
(220)
|
(167)
|
Total stockholders’ equity |
120,833
|
207,182
|
Total liabilities and stockholders’ equity |
$ 139,282
|
$ 225,690
|
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v3.23.3
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (Parenthetical) - $ / shares
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Preferred stock, par value (in dollars per share) |
$ 0.001
|
$ 0.001
|
Preferred stock, authorized |
5,000,000
|
5,000,000
|
Common stock, par value (in dollars per share) |
$ 0.001
|
$ 0.001
|
Common stock, authorized |
160,000,000
|
160,000,000
|
Common stock, issued |
17,762,341
|
12,368,620
|
Common stock, outstanding |
17,762,341
|
12,368,620
|
Common stock, to be issued |
|
14,999
|
Series B Preferred Stock [Member] |
|
|
Preferred stock, designated |
0
|
0
|
Preferred stock, issued |
0
|
0
|
Preferred stock, outstanding |
0
|
0
|
Series A Preferred Stock [Member] |
|
|
Preferred stock, designated |
0
|
0
|
Preferred stock, issued |
0
|
0
|
Preferred stock, outstanding |
0
|
0
|
X |
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v3.23.3
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
REVENUE: |
|
|
|
|
Product revenue, net |
$ 3,989
|
|
$ 3,989
|
|
COSTS AND EXPENSES: |
|
|
|
|
Cost of revenue |
2,374
|
|
2,374
|
|
Research and development |
21,050
|
22,201
|
69,535
|
57,202
|
Selling, general and administrative |
8,712
|
7,390
|
23,131
|
22,161
|
Costs and Expenses |
32,136
|
29,591
|
95,040
|
79,363
|
Operating loss |
(28,147)
|
(29,591)
|
(91,051)
|
(79,363)
|
Interest income, net |
172
|
610
|
1,715
|
825
|
Net loss |
(27,975)
|
(28,981)
|
(89,336)
|
(78,538)
|
Preferred stock deemed dividend |
|
|
|
4,255
|
Net loss available to common stockholders |
$ (27,975)
|
$ (28,981)
|
$ (89,336)
|
$ (82,793)
|
Net loss per common share, basic |
$ (1.83)
|
$ (4.24)
|
$ (7.40)
|
$ (18.58)
|
Net loss per common share, diluted |
$ (1.83)
|
$ (4.24)
|
$ (7.40)
|
$ (18.58)
|
Weighted average common shares outstanding, basic |
15,327,558
|
6,843,099
|
12,079,583
|
4,455,943
|
Weighted average common shares outstanding, diluted |
15,327,558
|
6,843,099
|
12,079,583
|
4,455,943
|
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- DefinitionThe aggregate cost of goods produced and sold and services rendered during the reporting period.
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v3.23.3
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (unaudited) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Net loss |
$ (27,975)
|
$ (28,981)
|
$ (89,336)
|
$ (78,538)
|
Other comprehensive loss: |
|
|
|
|
Foreign currency translation loss |
(8)
|
(17)
|
(53)
|
(68)
|
Comprehensive loss |
$ (27,983)
|
$ (28,998)
|
$ (89,389)
|
$ (78,606)
|
X |
- DefinitionAmount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.
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v3.23.3
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (unaudited) - USD ($) $ in Thousands |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
AOCI Attributable to Parent [Member] |
Retained Earnings [Member] |
Total |
Beginning balance, value at Dec. 31, 2021 |
$ 3
|
$ 578,626
|
$ (92)
|
$ (359,820)
|
$ 218,717
|
Balance, at beginning (in shares) at Dec. 31, 2021 |
2,634,110
|
|
|
|
|
Issuance of common stock in January and March 2022 under At-the-market offering, net of transactional expenses of $507 |
|
8,488
|
|
|
8,488
|
Issuance of common stock in January and March 2022 under At-the-market offering, net of transactional expenses of $507 (in shares) |
172,276
|
|
|
|
|
Issuance of common stock under the 2021 Purchase agreement |
|
4,535
|
|
|
4,535
|
Issuance of common stock under the 2021 Purchase agreement (in shares) |
110,000
|
|
|
|
|
Employee stock purchase plan |
|
40
|
|
|
40
|
Employee stock purchase plan (in shares) |
646
|
|
|
|
|
Stock-based compensation |
|
2,620
|
|
|
2,620
|
Foreign currency transaction gain |
|
|
(26)
|
|
(26)
|
Net loss |
|
|
|
(26,417)
|
(26,417)
|
Ending balance, value at Mar. 31, 2022 |
$ 3
|
594,309
|
(118)
|
(386,237)
|
207,957
|
Balance, at end (in shares) at Mar. 31, 2022 |
2,917,032
|
|
|
|
|
Beginning balance, value at Dec. 31, 2021 |
$ 3
|
578,626
|
(92)
|
(359,820)
|
218,717
|
Balance, at beginning (in shares) at Dec. 31, 2021 |
2,634,110
|
|
|
|
|
Foreign currency transaction gain |
|
|
|
|
(68)
|
Net loss |
|
|
|
|
(78,538)
|
Ending balance, value at Sep. 30, 2022 |
$ 9
|
667,433
|
(160)
|
(438,358)
|
228,924
|
Balance, at end (in shares) at Sep. 30, 2022 |
8,663,464
|
|
|
|
|
Beginning balance, value at Mar. 31, 2022 |
$ 3
|
594,309
|
(118)
|
(386,237)
|
207,957
|
Balance, at beginning (in shares) at Mar. 31, 2022 |
2,917,032
|
|
|
|
|
Issuance of common stock in April, May and June 2022 under At-the-market offering, net of transaction expenses of $1,426 |
$ 2
|
42,966
|
|
|
42,968
|
Issuance of common stock in April, May and June 2022 under At-the-market offering, net of transaction expenses of $1,426 (in shares) |
2,220,699
|
|
|
|
|
Issuance of common stock under the 2021 Purchase agreement |
|
1,964
|
|
|
1,964
|
Issuance of common stock under the 2021 Purchase agreement (in shares) |
65,000
|
|
|
|
|
Preferred stock dividend |
|
(4,255)
|
|
|
(4,255)
|
Stock-based compensation |
|
2,813
|
|
|
2,813
|
Foreign currency transaction gain |
|
|
(25)
|
|
(25)
|
Net loss |
|
|
|
(23,140)
|
(23,140)
|
Ending balance, value at Jun. 30, 2022 |
$ 5
|
637,797
|
(143)
|
(409,377)
|
228,282
|
Balance, at end (in shares) at Jun. 30, 2022 |
5,202,731
|
|
|
|
|
Issuance of common stock in July, August and September 2022 under At-the-market offering, net of transactional expenses of $805 |
$ 3
|
24,689
|
|
|
24,692
|
Issuance of common stock in July, August and September 2022 under At-the-market offering, net of transactional expenses of $805 (in shares) |
3,079,176
|
|
|
|
|
Issuance of common stock under the 2021 Purchase agreement |
$ 1
|
2,182
|
|
|
2,183
|
Issuance of common stock under the 2021 Purchase agreement (in shares) |
281,557
|
|
|
|
|
Issuance of commitment shares under 2022 Purchase Agreement |
|
|
|
|
|
Issuance of commitment shares under 2022 Purchase Agreement (in shares) |
100,000
|
|
|
|
|
Stock-based compensation |
|
2,765
|
|
|
2,765
|
Foreign currency transaction gain |
|
|
(17)
|
|
(17)
|
Net loss |
|
|
|
(28,981)
|
(28,981)
|
Ending balance, value at Sep. 30, 2022 |
$ 9
|
667,433
|
(160)
|
(438,358)
|
228,924
|
Balance, at end (in shares) at Sep. 30, 2022 |
8,663,464
|
|
|
|
|
Beginning balance, value at Dec. 31, 2022 |
$ 12
|
677,375
|
(167)
|
(470,038)
|
207,182
|
Balance, at beginning (in shares) at Dec. 31, 2022 |
12,368,620
|
|
|
|
|
Repurchase of common stock under Share Repurchase Program |
$ (3)
|
|
|
(13,962)
|
(13,965)
|
Repurchase of common stock under Share Repurchase Program (in shares) |
(2,672,044)
|
|
|
|
|
Issuance of common stock under 2022 Purchase agreement |
|
441
|
|
|
441
|
Issuance of common stock under 2022 Purchase agreement with Lincoln Park (in shares) |
96,000
|
|
|
|
|
Issuance of common stock under At-the-market offering, net of transactional expenses of $101 |
$ 1
|
1,994
|
|
|
1,995
|
Issuance of common stock under At-the-market offering, net of transactional expenses of $101 (in shares) |
514,502
|
|
|
|
|
Employee stock purchase plan |
|
29
|
|
|
29
|
Employee stock purchase plan (in shares) |
14,999
|
|
|
|
|
Stock-based compensation |
|
2,794
|
|
|
2,794
|
Foreign currency transaction gain |
|
|
(44)
|
|
(44)
|
Net loss |
|
|
|
(33,005)
|
(33,005)
|
Ending balance, value at Mar. 31, 2023 |
$ 10
|
682,633
|
(211)
|
(517,005)
|
165,427
|
Balance, at end (in shares) at Mar. 31, 2023 |
10,322,077
|
|
|
|
|
Beginning balance, value at Dec. 31, 2022 |
$ 12
|
677,375
|
(167)
|
(470,038)
|
207,182
|
Balance, at beginning (in shares) at Dec. 31, 2022 |
12,368,620
|
|
|
|
|
Foreign currency transaction gain |
|
|
|
|
(53)
|
Net loss |
|
|
|
|
(89,336)
|
Ending balance, value at Sep. 30, 2023 |
$ 18
|
694,371
|
(220)
|
(573,336)
|
120,833
|
Balance, at end (in shares) at Sep. 30, 2023 |
17,762,341
|
|
|
|
|
Beginning balance, value at Mar. 31, 2023 |
$ 10
|
682,633
|
(211)
|
(517,005)
|
165,427
|
Balance, at beginning (in shares) at Mar. 31, 2023 |
10,322,077
|
|
|
|
|
Issuance of common stock under At-the-market offering, net of transactional expenses of $36 |
$ 1
|
1,028
|
|
|
1,029
|
Issuance of common stock under At-the-market offering, net of transactional expenses of $36 (in shares) |
440,264
|
|
|
|
|
Stock-based compensation |
|
2,364
|
|
|
2,364
|
Foreign currency transaction gain |
|
|
(1)
|
|
(1)
|
Net loss |
|
|
|
(28,356)
|
(28,356)
|
Ending balance, value at Jun. 30, 2023 |
$ 11
|
686,025
|
(212)
|
(545,361)
|
140,463
|
Balance, at end (in shares) at Jun. 30, 2023 |
10,762,341
|
|
|
|
|
Issuance of common stock under AGP Financing, net of transactional expenses of $726 |
$ 3
|
6,271
|
|
|
6,274
|
Issuance of common stock under AGP Financing, net of transactional expenses of $726 (in shares) |
2,530,000
|
|
|
|
|
Issuance of common stock upon exercise of prefunded warrants under AGP Financing |
$ 4
|
(4)
|
|
|
|
Issuance of common stock upon exercise of prefunded warrants under AGP Financing (in shares) |
4,470,000
|
|
|
|
|
Stock-based compensation |
|
2,079
|
|
|
2,079
|
Foreign currency transaction gain |
|
|
(8)
|
|
(8)
|
Net loss |
|
|
|
(27,975)
|
(27,975)
|
Ending balance, value at Sep. 30, 2023 |
$ 18
|
$ 694,371
|
$ (220)
|
$ (573,336)
|
$ 120,833
|
Balance, at end (in shares) at Sep. 30, 2023 |
17,762,341
|
|
|
|
|
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v3.23.3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) - USD ($) $ in Thousands |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
Net loss |
$ (89,336)
|
$ (78,538)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
3,030
|
417
|
Gain on disposal of property and equipment |
(196)
|
|
Stock-based compensation |
7,237
|
8,198
|
Changes in operating assets and liabilities: |
|
|
Receivables, net |
(1,562)
|
|
Prepaid expenses and other |
3,334
|
(753)
|
Accounts payable |
446
|
(4,079)
|
Operating lease liabilities and ROU asset, net |
24
|
5
|
Accrued expenses and other current liabilities |
(2,640)
|
(1,002)
|
Net cash used in operating activities |
(79,663)
|
(75,752)
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
Purchase of a business |
(22,174)
|
|
Disposal of property and equipment |
992
|
|
Purchase of property and equipment |
(7,457)
|
(43,476)
|
Net cash used in investing activities |
(28,639)
|
(43,476)
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
Proceeds from ESPP |
29
|
40
|
Proceeds, net of $0 and $4,255 expenses, from sale of convertible redeemable preferred stock |
|
27,245
|
Redemption of convertible redeemable preferred stock |
|
(31,500)
|
Repurchase of common stock |
(13,965)
|
|
Proceeds, net of $863 and $2,738 expenses, from sale of common stock |
9,739
|
84,830
|
Net cash (used in) provided by financing activities |
(4,197)
|
80,615
|
Effect of currency rate change on cash |
(55)
|
(69)
|
Net decrease in cash, cash equivalents and restricted cash |
(112,554)
|
(38,682)
|
Cash, cash equivalents and restricted cash beginning of the period |
120,470
|
178,900
|
Cash, cash equivalents and restricted cash end of period |
7,916
|
140,218
|
Non-cash financing and investing activities: |
|
|
Purchases of property and equipment included in accounts payable and accrued liabilities |
275
|
(3,310)
|
Preferred stock deemed dividend |
|
$ 4,255
|
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v3.23.3
BUSINESS
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
BUSINESS |
NOTE 1 – BUSINESS
Tonix Pharmaceuticals
Holding Corp., through its wholly owned subsidiary Tonix Pharmaceuticals, Inc. (“Tonix Sub”), is a biopharmaceutical
company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate
suffering. The therapeutics under development include both small molecules and biologics. Tonix, through its recent acquisition,
markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace®
SymTouch® and Tosymra®, which were acquired as of June 30, 2023 (See Note 10), are each indicated for the treatment of
acute migraine with or without aura in adults. All other drug product and vaccine candidates are still in development, and are
not approved or marketed.
The condensed consolidated
financial statements include the accounts of Tonix Pharmaceuticals Holding Corp. and its wholly owned subsidiaries, Tonix Sub,
Krele LLC, Tonix Pharmaceuticals (Canada), Inc., Tonix Medicines, Inc., Jenner LLC, Tonix R&D Center LLC, Tonix Pharma Holdings
Limited and Tonix Pharma Limited (collectively hereafter referred to as the “Company” or “Tonix”). All
intercompany balances and transactions have been eliminated in consolidation.
Going Concern
The accompanying financial
statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates
the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company has suffered
recurring losses from operations and negative cash flows from operating activities. At September 30, 2023, the Company had working
capital of approximately $13.6 million. At September 30, 2023, the Company had an accumulated deficit of approximately $573.3 million.
The Company held cash and cash equivalents of approximately $6.9 million as of September 30, 2023.
The
Company believes that its cash resources at September 30, 2023 and the proceeds that it raised from equity offerings in the fourth
quarter of 2023 (See Note 20), will not meet its operating and capital expenditure requirements through the fourth quarter of 2023.
These factors raise substantial doubt about the Company’s ability
to continue as a going concern. The Company continues to face significant challenges and uncertainties and must obtain additional funding
through public and private financing and collaborative arrangements with strategic partners to increase the funds available to fund operations.
However, the Company may not be able to raise capital on terms acceptable to the Company, or at all. Without additional funds, it may
be forced to delay, scale back or eliminate some of its research and development activities, or other operations and potentially delay
product development in an effort to provide sufficient funds to continue operations. If any of these events occurs, its ability to achieve
our development and commercialization goals would be adversely affected and the Company may be forced to cease operations. The financial
statements do not include any adjustments that might result from the outcome of this uncertainty.
|
X |
- DefinitionThe entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward.
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v3.23.3
SIGNIFICANT ACCOUNTING POLICIES
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
SIGNIFICANT ACCOUNTING POLICIES |
NOTE 2 – SIGNIFICANT ACCOUNTING
POLICIES
Interim financial statements
The unaudited condensed
consolidated interim financial statements of the Company have been prepared in accordance with accounting principles generally
accepted in the United States (“GAAP”) for interim financial information and the instructions to Form 10-Q and Article
8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial
statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a
fair presentation have been included.
The condensed consolidated
balance sheet as of December 31, 2022 contained herein has been derived from audited financial statements.
Operating results for
the three and nine months ended September 30, 2023 are not necessarily indicative of results that may be expected for the year
ending December 31, 2023. These condensed consolidated financial statements should be read in conjunction with the audited consolidated
financial statements and notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form
10-K, filed with the Securities and Exchange Commission (“SEC”) on March 13, 2023.
Reverse Stock Split
On May 9, 2023, the
Company filed a Certificate of Change with the Nevada Secretary of State, effective May 10, 2023. Pursuant to the Certificate of
Change, the Company effected a 1-for-6.25 reverse stock split of its issued and outstanding shares of common stock. The Company
accounted for the reverse stock split on a retrospective basis pursuant to ASC 260, Earnings Per Share. All authorized, issued
and outstanding common stock, common stock warrants, stock option awards, exercise prices and per share data have been adjusted
in these condensed consolidated financial statements, on a retrospective basis, to reflect the reverse stock split for all periods
presented. Authorized preferred stock was not adjusted because of the reverse stock split.
Risks and uncertainties
The Company’s primary efforts are devoted to conducting research
and development of innovative pharmaceutical and biological products to address public health challenges. The Company has experienced
net losses and negative cash flows from operations since inception and expects these conditions to continue for the foreseeable future.
Further, the Company now has commercial products available for sale, and generates revenue from the sale of its Zembrace® SymTouch®
and Tosymra® products, with no assurance that the Company will be able to generate sufficient cash flow to fund operations from its
commercial products or products in development if and when approved. In addition, there can be no assurance that the Company’s research
and development will be successfully completed or that any product will be approved or commercially viable.
Use of estimates
The preparation of financial
statements in accordance with Generally Accepted Accounting Principles (“GAAP”) requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities
at the date of the financial statements, and the reported amounts of expenses during the reporting period. Actual results could
differ from those estimates. Significant estimates include, but are not limited to, provisions for product returns, coupons, rebates,
chargebacks, discounts, allowances, inventory realization, the assumptions used in the fair value of stock-based compensation and
other equity instruments, the percent of completion of research and development contracts, fair value estimates for assets acquired
in business combinations, and assessment of useful lives of acquired intangible assets.
Business Combinations
The Company accounts
for business combinations in accordance with the provisions of ASC 805, Business Combinations and ASU No. 2017-01, Business Combinations
(Topic 805): Clarifying the Definition of a Business. Business combinations are accounted for using the acquisition method, whereby
the consideration transferred is allocated to the net assets acquired based on their respective fair values measured on the acquisition
date. The difference between the fair value of these assets and the purchase price is recorded as goodwill. Transaction costs other
than those associated with the issue of debt or equity securities, and other direct costs of a business combination are not considered
part of the business acquisition transaction and are expensed as incurred.
Segment Information and Concentrations
Operating segments are
defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating
decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views
its operations and manages its business in one segment.
The Company has two
products that each accounted for more than 10% of total revenues during the three and nine months ended September 30, 2023. These
products collectively accounted for 100% of revenues during the three and nine months ended September 30, 2023.
As
of September 30, 2023, accounts receivable from four customers accounted for 25%, 23%, 19%
and 15%
of total accounts receivable. For the three and nine months ended September 30, 2023, revenues from four customers accounted
for 25%, 21%, 18%
and 14%
of net product revenues, respectively. As of September 30, 2022, and for the three and nine months ended September 30, 2022,
the Company had no commercialized products and therefore had no accounts receivables or revenues.
Cash, Cash Equivalents and Restricted Cash
The Company considers
cash equivalents to be those investments which are highly liquid, readily convertible to cash and have an original maturity of
three months or less when purchased. At September 30, 2023 and December 31, 2022, cash equivalents, which consisted of money market
funds, amounted to $3.7 million and $116.3 million, respectively. Restricted cash, which is included in Other non-current assets
on the condensed consolidated balance sheet, at both September 30, 2023, and December 31, 2022, of approximately $244,000 and $241,000,
respectively, collateralizes a letter of credit issued in connection with the lease of office space in Chatham, New Jersey and
New York, New York (see Note 18). In addition, the Company has $758,000 of restricted cash held by vendors in escrow accounts for patient support services as of September 30, 2023.
The following table
provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets
that sum to the total of the same amounts shown in the condensed consolidated statement of cash flows:
|
|
September 30,
2023 |
|
|
September 30,
2022 |
|
|
|
(in thousands) |
|
Cash and cash equivalents |
|
$ |
6,914 |
|
|
$ |
139,978 |
|
Restricted cash |
|
|
1,002 |
|
|
|
240 |
|
Total |
|
$ |
7,916 |
|
|
$ |
140,218 |
|
Accounts Receivable, net
Accounts receivable consists of amounts due from our wholesale and other third-party distributors and pharmacies and have standard
payment terms that generally require payment within 30 to 90 days. For certain customers, the accounts receivable for the customer
is net of prompt payment or specialty pharmacy discounts. We do not adjust our receivables for the effects of a significant financing
component at contract inception if we expect to collect the receivables in one year or less from the time of sale. We provide reserves
against accounts receivable for estimated losses that may result from a customer’s inability to pay. Amounts determined to
be uncollectible are charged or written-off against the reserve. However, during the period covered by the Transition Services
Agreement, the Seller has agreed to collect the accounts receivable on behalf of the Company and net settle within 45 days from
each month-end. See note 10 for further details. The Company had no accounts receivable as of any prior period presented other than as of September 30, 2023.
As of September
30, 2023, the Company did not have an allowance for doubtful accounts. An allowance for doubtful accounts is determined based on
the financial condition and creditworthiness of customers and the Company considers economic factors and events or trends expected to
affect future collections experience. Any allowance would reduce the net receivables to the amount that is expected to be collected. The
payment history of the Company’s customers will be considered in future assessments of collectability as these patterns are established
over a longer period.
Concentration of Credit Risk
Financial instruments
that potentially subject us to concentrations of credit risk include cash and cash equivalents, and accounts receivable. We attempt
to minimize the risks related to cash and cash equivalents by investing in a broad and diverse range of financial instruments,
and we have established guidelines related to credit ratings and maturities intended to safeguard principal balances and maintain
liquidity. Concentrations of credit risk with respect to receivables, which are typically unsecured, are somewhat mitigated due
to the wide variety of customers using our products, as well as their dispersion across different geographic areas.
We monitor the financial
performance and creditworthiness of our customers so that we can properly assess and respond to changes in their credit profile.
We continue to monitor these conditions and assess their possible impact on our business.
Inventories
Inventories are recorded
at the lower of cost or net realizable value, with cost determined by the weighted average cost method. The Company periodically
reviews the composition of inventory in order to identify excess, obsolete, slow-moving or otherwise non-saleable items taking
into account anticipated future sales compared with quantities on hand, and the remaining shelf life of goods on hand. If non-saleable
items are observed and there are no alternate uses for the inventory, the Company records a write-down to net realizable value
in the period that the decline in value is first recognized. Although the Company makes every effort to ensure the accuracy of
forecasts of future product demand, any significant unanticipated decreases in demand could have a material impact on the carrying
value of inventories and reported operating results. The Company’s reserves were approximately $21,000 as of September 30,
2023. The Company did not have inventory on hand prior to the acquisition of Zembrace and Tosymra on June 30, 2023.
Property and equipment
Property and equipment
are stated at cost, less accumulated depreciation. Depreciation is calculated using the straight-line method over the asset’s
estimated useful life, which ranges from 20 to 40 years for buildings, 15 years for land improvements and laboratory equipment,
three years for computer assets, five years for furniture and all other equipment and the shorter of the useful life or term of
lease for leasehold improvements. Depreciation on assets begins when the asset is placed in service. Depreciation and amortization
expense for the three and nine months ended September 30, 2023, was $978,000 and $2.8 million, respectively, and $252,000
and $417,000, respectively, for the three and nine months ended September 30, 2022. All property and equipment are located in the
United States.
Intangible assets, net
Intangible assets deemed
to have finite lives are carried at acquisition-date fair value less accumulated amortization and impairment, if any. Finite-lived
intangible assets consist of developed technology intangible assets acquired in connection with the acquisition of certain products
from Upsher Smith Laboratories, LLS (“USL Acquisition”) consummated on June 30, 2023 (See Note 8). The acquired intangible
assets are amortized using the straight-line method over the estimated useful lives of the respective assets. Amortization expense
for the three months ended September 30, 2023, was $238,000. The annual impairment assessment date will be June 30. No triggering events were identified during the nine months ended September 30, 2023.
During the year ended
December 31, 2015, the Company purchased certain internet domain rights, which were determined to have an indefinite life. Identifiable
intangibles with indefinite lives, which are included in Intangible assets, net on the condensed consolidated balance sheet, are
not amortized but are tested for impairment annually or whenever events or changes in circumstances indicate that their carrying
amount may be less than fair value. As of September 30, 2023, the Company believed that no impairment existed.
Goodwill
Goodwill represents
the excess of the aggregate purchase price over the fair value of the net tangible and intangible assets acquired in a business
combination. Goodwill is reviewed for impairment on an annual basis, or more frequently if events or changes in circumstances indicate
that the carrying amount of goodwill may be impaired. As of September 30, 2023, the Company has recognized goodwill in connection with
the USL Acquisition consummated on June 30, 2023 (See Note 8).
Leases
The Company determines
if an arrangement is, or contains, a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”)
assets, operating lease liabilities, current and operating lease liabilities, noncurrent in the Company’s condensed consolidated
balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities
represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized
at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide
an implicit rate, the Company uses an incremental borrowing rate based on the information available at the transition date and
subsequent lease commencement dates in determining the present value of lease payments. This is the rate the Company would have
to pay if borrowing on a collateralized basis over a similar term to each lease. The operating lease ROU asset excludes lease incentives.
The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company
will exercise that option. Lease expense for lease payments made under operating leases is recognized on a straight-line basis
over the lease term.
Convertible Preferred Stock
Preferred shares subject
to mandatory redemption are classified as liability instruments and are measured at fair value. The Company classifies conditionally
redeemable preferred shares, which includes preferred shares that feature redemption rights that are either within the control
of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control, as
temporary equity (“mezzanine”) until such time as the conditions are removed or lapse.
Revenue Recognition
The
Company records and recognizes revenue in a manner that depicts the transfer of promised goods or services to customers in an
amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services.
The Company’s revenues primarily result from contracts with customers, which are generally short-term and have a single
performance obligation - the delivery of product. The Company’s performance obligation to deliver products is satisfied
at the point in time that the goods are received by the customer, which is when the customer obtains title to and has the
risks and rewards of ownership of the products, which is generally upon shipment or delivery to the customer as stipulated by
the terms of the sale agreements. The transaction price is the amount of consideration to
which the Company expects to be entitled in exchange for transferring promised goods to a customer. The consideration promised
in a contract with a customer may include fixed amounts, variable amounts, or both. Our contractual payment terms are typically 30 to 90 days.
Revenues from product
sales, net of gross-to-net deductions, are recorded only to the extent a significant reversal in the amount of cumulative revenue
recognized is not probable of occurring and when the uncertainty associated with gross-to-net deductions is subsequently resolved.
Taxes assessed by governmental authorities and collected from customers are excluded from product sales. Shipping and handling
activities are considered to be fulfillment activities and not a separate performance obligation.
Many of the Company’s
products sold are subject to a variety of deductions. Revenues are recognized net of estimated rebates and chargebacks, cash discounts,
distributor fees, sales return provisions and other related deductions. Deductions to product sales are referred to as gross-to-net
deductions and are estimated and recorded in the period in which the related product sales occur. Accruals for these provisions
are presented in the consolidated financial statements as reductions to gross sales in determining net sales, and as a contra asset
within accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash). Amounts recorded for revenue
deductions can result from a complex series of judgements about future events and uncertainties and can rely heavily on estimates
and assumptions. The following section briefly describes the nature of the Company’s provisions for variable consideration
and how such provisions are estimated:
Chargebacks -
The Company sells a portion of its products indirectly through wholesaler distributors, and enters into specific agreements with
these indirect customers to establish pricing for the Company’s products, and in-turn, the indirect customers and entities
independently purchase these products. Because the price paid by the indirect customers and/or entities is lower than the price
paid by the wholesaler, the Company provides a credit, called a chargeback, to the wholesaler for the difference between the contractual
price with the indirect customers and the wholesale customer’s purchase price. The Company’s provision for chargebacks
is based on expected sell-through levels by the Company’s wholesale customers to the indirect customers and estimated wholesaler
inventory levels as well as historical chargeback rates. The Company continually monitors its reserve for chargebacks and adjusts
the reserve accordingly when expected chargebacks differ from actual experience.
Rebates - The
Company participates in certain government and specific sales rebate programs which provides discounted prescription drugs to qualified
recipients, and primarily relate to Medicaid and managed care rebates in the U.S., pharmacy rebates, Tri-Care rebates and discounts,
specialty pharmacy program fees and other governmental rebates or applicable allowances.
| ● | Managed Care Rebates are processed in the quarter following the quarter in which they are earned.
The managed care reporting entity submits utilization data after the end of the quarter and the Company processes the payment in
accordance with contract terms. All rebates earned but not paid are estimated by the Company according to historical payments trended
for market growth assumptions. |
| ● | Medicaid and State Agency rebates are based upon historical experience of claims submitted by various
states. The Company monitors Medicaid legislative changes to determine what impact such legislation may have on the provision for
Medicaid rebates. The accrual of State Agency reserves is based on historical payment rates. There is an approximate three-month
lag from the time of product sale until the rebate is paid. |
| ● | Tri-Care represents a regionally managed health care program for active duty and retired members,
dependents and survivors of the US military. The Tri-Care program supplements health care resources of the US military with civilian
health care professionals for greater access and quality healthcare coverage. Through the Tri-Care program, the Company provides
pharmaceuticals on a direct customer basis. Prices of pharmaceuticals sold under the Tri-Care program are pre-negotiated and a
reserve amount is established to represent the proportionate rebate amount associated with product sales. |
| ● | Coverage Gap refers to the Medicare prescription drug program and represents specifically the period
between the initial Medicare Part D prescription drug program coverage limit and the catastrophic coverage threshold. Applicable
pharmaceutical products sold during this coverage gap timeframe are discounted by the Company. Since the nature of the program
is that coverage limits are reset at the beginning of the calendar year; the payments escalate each quarter as the participants
reach the coverage limit before reaching the catastrophic coverage threshold. The Company has determined that the cost of this
reserve will be viewed as an annual cost. Therefore, the accrual will be incurred evenly during the year with quarterly review
of the liability based on payment trends and any revision to the projected annual cost. |
Prompt-Pay and other
Sales Discounts - The Company provides for prompt pay discounts, which early payments are recorded as a reduction of revenue
and as a reduction in the accounts receivable at the time of sale based on the customer’s contracted discount rate. Consumer
sales discounts represent programs the Company has in place to reduce costs to the patient. This includes copay buy down and eVoucher
programs.
Product Returns
- Consistent with industry practice, the Company offers customers a right to return any unused product. The customer’s right
of return commences typically six months prior to product expiration date and ends one year after product expiration date. Products returned
for expiration are reimbursed at current wholesale acquisition cost or indirect contract price. The Company estimates the amount
of its product sales that may be returned by the Company’s customers and accrues this estimate as a reduction of revenue
in the period the related product revenue is recognized. The Company estimates products returns as a percentage of sales to its
customers. The rate is estimated by using historical sales information, including its visibility and estimates into the inventory
remaining in the distribution channel. Adjustments are made to the current provision for returns when data suggests product returns
may differ from original estimates.
Research and Development Costs
The Company outsources
certain of its research and development efforts and expenses these costs as incurred, including the cost of manufacturing products
for testing, as well as licensing fees and costs associated with planning and conducting clinical trials. The value ascribed to
patents and other intellectual property acquired has been expensed as research and development costs, as such property is related
to particular research and development projects and had no alternative future uses.
The Company estimates
its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under
clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations,
which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services
are provided under such contracts. The Company accounts for trial expenses according to the timing of various aspects of the trial.
The Company determines accrual estimates taking into account discussion with applicable personnel and outside service providers
as to the progress or state of consummation of trials, or the services completed.
During the course of
a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company
makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that
time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations
and other third-party vendors.
Government Grants
From time to time, the
Company may enter into arrangements with governmental entities for the purpose of obtaining funding for research and development
activities. The Company is reimbursed for costs incurred that are associated with specified research and development activities
included in the grant application approved by the government authority. The Company classifies government grants received under
these arrangements as a reduction to the related research and development expense in the same period as the relevant expenses are
incurred. In August 2022, the Company announced that it received a Cooperative Agreement grant from the National Institute on Drug
Abuse (“NIDA”), part of the National Institutes of Health, to support the development of its TNX-1300 product candidate
for the treatment of cocaine intoxication. During the three and nine months ended September 30, 2023, we received $0.4 and $2.3
million, respectively, for the three and nine months ended September 30, 2023, in funding as a reduction of related research and
development expense.
Stock-based compensation
All stock-based payments
to employees and to nonemployees for their services, including grants of restricted stock units (“RSUs”), and stock
options, are measured at fair value on the grant date and recognized in the condensed consolidated statements of operations as
compensation or other expense over the requisite service period. The Company accounts for share-based awards in accordance with
the provisions of the Accounting Standards Codification (“ASC”) 718, Compensation – Stock Compensation.
Foreign Currency Translation
Operations of the Company’s
Canadian subsidiary, Tonix Pharmaceuticals (Canada), Inc., are conducted in local currency, which represents its functional currency.
The U.S. dollar is the functional currency of the other foreign subsidiaries. Balance sheet accounts of the Canadian subsidiary
were translated from foreign currency into U.S. dollars at the exchange rate in effect at the balance sheet date and income statement
accounts were translated at the average rate of exchange prevailing during the period. Translation adjustments resulting from this
process were included in accumulated other comprehensive loss on the consolidated condensed balance sheets.
Comprehensive Income (Loss)
Comprehensive income
(loss) is defined as the change in equity of a business during a period from transactions and other events and circumstances from
non-owners sources. It includes all changes in equity during a period except those resulting from investments by owners and distributions
to owners. Other comprehensive income (loss) represents foreign currency translation adjustments.
Income Taxes
Deferred income tax
assets and liabilities are determined based on the estimated future tax effects of net operating loss and credit carryforwards
and temporary differences between the tax basis of assets and liabilities and their respective financial reporting amounts measured
at the current enacted tax rates. The Company records a valuation allowance on its deferred income tax assets if it is not more
likely than not that these deferred income tax assets will be realized.
The Company recognizes
a tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination
by taxing authorities, based on the technical merits of the position. The tax benefits recognized in the condensed consolidated
financial statements from such a position are measured based on the largest benefit that has a greater than 50% likelihood of being
realized upon ultimate settlement. As of September 30, 2023, the Company has not recorded any unrecognized tax benefits. The Company’s
policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.
Per Share Data
The computation of basic
and diluted loss per share for the quarters ended September 30, 2023 and 2022 excludes potentially dilutive securities when their
inclusion would be anti-dilutive, or if their exercise prices were greater than the average market price of the common stock during
the period.
All warrants and preferred
stock issued participate on a one-for-one basis with common stock in the distribution of dividends, if and when declared by the
Board of Directors, on the Company’s common stock. For purposes of computing EPS, these warrants and preferred stock are
considered to participate with common stock in earnings of the Company. Therefore, the Company calculates basic and diluted EPS
using the two-class method. Under the two-class method, net income for the period is allocated between common stockholders and
participating securities according to dividends declared and participation rights in undistributed earnings. No income was allocated
to the warrants and preferred stock for the three and nine months ended September 30, 2023, and 2022, as results of operations
were a loss for the periods.
Potentially dilutive
securities excluded from the computation of basic and diluted net loss per share, as of September 30, 2023 and 2022, are as follows:
|
|
2023 |
|
|
2022 |
|
Warrants to purchase common stock |
|
|
7,003,196 |
|
|
|
3,196 |
|
Options to purchase common stock |
|
|
1,384,264 |
|
|
|
392,643 |
|
Totals |
|
|
8,387,460 |
|
|
|
395,839 |
|
Recently Adopted Accounting Pronouncements
In August 2020, the
FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts
in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity,
which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU
also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative scope exception,
and it also simplifies the diluted earnings per share calculation in certain areas. The Company adopted ASU 2020-06 on January
1, 2023, under the modified retrospective method of transition. The adoption of ASU 2020-06 did not impact the Company’s
financial position, results of operations or cash flows.
In June 2016, the FASB
issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments. The main objective of ASU 2016-13 is to provide financial
statement users with more decision-useful information about an entity’s expected credit losses on financial instruments and
other commitments to extend credit at each reporting date. To achieve this objective, the amendments in this update replace the
incurred loss impairment methodology currently used today with a methodology that reflects expected credit losses and requires
consideration of a broader range of reasonable and supportable information to develop credit loss estimates. ASU 2016-13 will be
effective for the Company for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years,
using a modified retrospective approach. Early adoption is permitted. The Company adopted ASU 2016-13 and related updates as of
January 1, 2023. The adoption of ASU 2016-13 did not impact the Company’s financial position, results of operations or cash
flows.
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v3.23.3
INVENTORY
|
9 Months Ended |
Sep. 30, 2023 |
Inventory Disclosure [Abstract] |
|
INVENTORY |
NOTE 3 – INVENTORY
The components of inventory
consisted of the following as of September 30, 2023:
|
|
September
30,
2023 |
|
|
December
31,
2022 |
|
|
|
(in
thousands) |
|
Raw Materials |
|
$ |
3,064 |
|
|
$ |
— |
|
Work-in-process |
|
|
1,565 |
|
|
|
— |
|
Finished Goods |
|
|
8,709 |
|
|
|
— |
|
|
|
|
13,338 |
|
|
$ |
— |
|
Less: Inventory reserves |
|
|
(21 |
) |
|
|
— |
|
Total Inventory |
|
$ |
13,317 |
|
|
$ |
— |
|
|
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v3.23.3
PROPERTY AND EQUIPMENT, NET
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
PROPERTY AND EQUIPMENT, NET |
NOTE 4 – PROPERTY AND EQUIPMENT,
NET
Property and equipment,
net consisted of the following (in thousands):
|
|
September 30,
2023 |
|
|
December 31,
2022 |
|
|
|
(in thousands) |
|
Property and equipment, net: |
|
|
|
|
|
|
|
|
Land |
|
$ |
8,011 |
|
|
$ |
8,011 |
|
Land improvements |
|
|
326 |
|
|
|
79 |
|
Buildings |
|
|
65,825 |
|
|
|
65,644 |
|
Office furniture and equipment |
|
|
2,355 |
|
|
|
1,893 |
|
Laboratory equipment |
|
|
21,506 |
|
|
|
18,440 |
|
Leasehold improvements |
|
|
34 |
|
|
|
34 |
|
Construction in progress |
|
|
1,204 |
|
|
|
1,366 |
|
|
|
|
99,261 |
|
|
|
95,467 |
|
Less: Accumulated depreciation and amortization |
|
|
(4,395 |
) |
|
|
(1,653 |
) |
|
|
$ |
94,866 |
|
|
$ |
93,814 |
|
On October 1, 2021,
the Company completed the acquisition of its approximately 45,000 square foot research and development facility in Frederick, Maryland
totaling $17.5 million, to process development activities. Of the total purchase price, $2.1 million was allocated to the value
of land acquired, and $13.9 million was allocated to buildings, and approximately $1.5 million was allocated to office furniture
and equipment and laboratory equipment. During 2022, the assets became ready for the intended use and were placed in service.
On September 28, 2020,
the Company completed the purchase of its approximately 45,000 square foot facility in Dartmouth, Massachusetts for $4.0 million,
to house its new Advanced Development Center for the development and manufacturing of vaccines. Of the total purchase price, $1.2
million was allocated to the value of land acquired, and $2.8 million was allocated to buildings. Additionally, the Company incurred
approximately $38.8 million of costs during the year ended December 31, 2022, bringing total costs incurred-to-date to $61.6 million,
of which the majority related to the build-out of the facility. During 2022, the assets became ready for the intended use and were
placed in service.
On December 23, 2020,
the Company completed the purchase of its approximately 44-acre site in Hamilton, Montana for $4.5 million, for the construction
of a vaccine development and commercial scale manufacturing facility. As of September 30, 2023, the asset was not ready for its
intended use.
During the quarter ended
September 30, 2023, property and equipment with a net book value of approximately $0.8 million were sold for net proceeds of approximately
$1.0 million.
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v3.23.3
GOODWILL AND INTANGIBLE ASSETS
|
9 Months Ended |
Sep. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
GOODWILL AND INTANGIBLE ASSETS |
NOTE 5 – GOODWILL AND INTANGIBLE ASSETS
The following table
provides the gross carrying value of goodwill as follows:
|
|
Amounts |
|
|
|
(in thousands) |
Balance at December 31, 2022 |
|
$ |
— |
|
Acquired during the period (see Note 8) |
|
|
965 |
|
Balance at September 30, 2023 |
|
$ |
965 |
|
The following table
provides the gross carrying amount and accumulated amortization for each major class of intangible asset:
|
|
September 30,
2023 |
|
|
December 31,
2022 |
|
|
|
(in thousands) |
|
Intangible assets subject to amortization |
|
|
|
|
|
|
|
|
Developed technology |
|
$ |
10,100 |
|
|
$ |
— |
|
Less: Accumulated amortization |
|
|
238 |
|
|
|
— |
|
Total |
|
$ |
9,862 |
|
|
$ |
— |
|
Intangible assets not subject to amortization |
|
|
|
|
|
|
|
|
Internet domain rights |
|
$ |
120 |
|
|
$ |
120 |
|
Total intangible assets, net |
|
$ |
9,982 |
|
|
$ |
120 |
|
During the three months ended September 30,
2023, the Company recorded amortization of $238,000.
At September 30, 2023,
the related amortization for each of the next five years ended December 31 is as follows (in thousands):
Year Ending December 31, |
|
|
|
|
Remainder of 2023 |
|
|
$ |
238 |
|
2024 |
|
|
|
953 |
|
2025 |
|
|
|
953 |
|
2026 |
|
|
|
953 |
|
2027 and beyond |
|
|
|
6,765 |
|
|
|
|
$ |
9,862 |
|
|
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v3.23.3
FAIR VALUE MEASUREMENTS
|
9 Months Ended |
Sep. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
FAIR VALUE MEASUREMENTS |
NOTE 6 – FAIR VALUE MEASUREMENTS
Fair
value measurements affect the Company’s accounting for certain of its financial assets. Fair value is defined as 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 and is measured according to a hierarchy that includes:
|
Level
1: |
Observable
inputs, such as quoted prices in active markets. |
|
Level
2: |
Inputs,
other than quoted prices in active markets, that are observable either directly or indirectly. Level 2 assets and liabilities
include debt securities with quoted market prices that are traded less frequently than exchange-traded instruments. This category
includes U.S. government agency-backed debt securities and corporate-debt securities. |
|
Level 3: |
Unobservable
inputs in which there is little or no market data. |
As of September 30,
2023, and December 31, 2022, the Company used Level 1 quoted prices in active markets to value cash equivalents of $3.7 million
and $116.3 million, respectively. The Company did not have any Level 2 or Level 3 assets or liabilities as of both September 30,
2023 and December 31, 2022.
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v3.23.3
STOCKHOLDERS’ EQUITY
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
STOCKHOLDERS’ EQUITY |
NOTE 7 – STOCKHOLDERS’ EQUITY
On May 9, 2023, the
Company filed a Certificate of Change with the Nevada Secretary of State, effective May 10, 2023. Pursuant to the Certificate of
Change, the Company effected a 1-for-6.25 reverse stock split of its issued and outstanding shares of common stock, whereby 64,627,246
outstanding shares of the Company’s common stock were exchanged for 10,340,506 shares of the Company’s common stock.
In connection with the reverse stock split, the Company issued an additional 131,902 shares of the Company’s common stock
due to fractional shares. Furthermore, pursuant to the Certificate of Change, the number of authorized shares of common stock was
reduced from 1,000,000,000 to 160,000,000. All per share amounts and number of shares in the condensed consolidated financial statements
and related notes have been retroactively restated to reflect the reverse stock split.
On October 17, 2023,
the Company received a letter from the Listing Qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”)
indicating that, based upon the closing bid price of the Company’s common stock for the last 30 consecutive business days,
the Company no longer meets the requirement to maintain a minimum bid price of $1 per share, as set forth in Nasdaq Listing Rule
55450(a)(1) (the “Minimum Bid Price Requirement”).
The
Company was initially provided with a 180
calendar day period, or until April 15, 2024, in which to regain compliance. In the event that the Company does not regain compliance
within this 180-day
period, the Company may be eligible to seek an additional 180
day compliance period if it meets the continued listing requirement for market value of publicly held shares and all other initial listing
standards for the Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and provides written notice to Nasdaq
of its intent to cure the deficiency during this second compliance period, by effecting a reverse stock split, if necessary.
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v3.23.3
TEMPORARY EQUITY
|
9 Months Ended |
Sep. 30, 2023 |
Temporary Equity |
|
TEMPORARY EQUITY |
NOTE 8 – TEMPORARY EQUITY
On October 26, 2022,
the Company closed on an offering (“the October offering”) with certain institutional investors (the “Investors”),
pursuant to which the Company issued and sold, in a private placement, 1,400,000 shares of the Company’s Series A Convertible
Redeemable Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”), and 100,000 shares of the
Company’s Series B Convertible Redeemable Preferred Stock, par value $0.001 per share (the “Series B Preferred Stock,”
and together with the Series A Preferred Stock, the “Preferred Stock”), at an offering price of $9.50 per share, representing
a 5% original issue discount (“OID) to the stated value of $10.00 per share, for gross proceeds of $14.3 million in the aggregate
for the October offering, before the deduction of fees and offering expenses. The shares of Preferred Stock were convertible, at
a conversion price of $6.25 per share (subject in certain circumstances to adjustments), into shares of the Company’s common
stock, at the option of the holders and, in certain circumstances, by the Company.
On December 13, 2022,
an amendment (the “December Amendment”) to the Company’s Articles of Incorporation, as amended, to increase the
Company’s authorized shares of common stock from 24,000,000 to 160,000,000, as adjusted for the reverse split, was approved
at a special meeting of shareholders. The Series A Preferred Stock had the right to vote on such December Amendment on an as-converted
to common stock basis. The shares of the Series B Preferred Stock were automatically voted in a manner that “mirrored”
the proportions on which the shares of common stock (excluding any shares of common stock that were not voted) and Series A Preferred
Stock were voted to increase the Authorized Shares. The December Amendment required the approval of the majority of the votes associated
with the Company’s outstanding stock entitled to vote on the proposal. Because the Series B Preferred Stock were automatically
and without further action of the purchaser voted in a manner that “mirrored” the proportions on which the shares of
common stock (excluding any shares of common stock that were not voted) and Series A Preferred Stock were voted on the December
Amendment, abstentions by common stockholders did not have any effect on the votes cast by the holders of the Series B Preferred
Stock. The Certificates of Designation for the Preferred Stock provides that the Preferred Stock have no voting rights other than
the right to vote on the December Amendment and as a class on certain other specified matters, and, with respect to the Series
B Certificate of Designation, the right to cast 2,500 votes per share of Series B Preferred Stock on the December Amendment.
The holders of Preferred
Stock were entitled to dividends, on an as-if converted basis, equal to dividends actually paid, if any, on shares of common stock.
The Preferred Stock was convertible, at the option of the holders and, in certain circumstances, by the Company, into shares of
common stock at a conversion price of $6.25 per share. The holders of the Preferred Stock had the right to require the Company
to redeem their shares of preferred stock for cash at 105% of the stated value of such shares through January 23, 2023. The Company
had the option to redeem the Preferred Stock for cash at 105% of the stated value, subject to the holders’ rights to convert
the shares prior to such redemption.
The $14.3 million in
gross proceeds of the October offering was held in an escrow account, along with an additional $1.5 million deposited by the Company
to cover the aggregate OID as well as the additional amount that would be necessary to fund the 105% redemption price until the
expiration of the redemption period for the Preferred Stock, as applicable, subject to the earlier payment to redeeming holders.
Upon expiration of the redemption period, any proceeds remaining in the escrow account would be disbursed to the Company.
Since the Preferred
Stock had a redemption feature at the option of the holder, it was classified as temporary equity. The Series A Preferred Stock
and Series B Preferred Stock was recorded at redemption value of approximately $14.7 million and $1.1 million, respectively, as
calculated in the following table (in thousands):
|
|
Series A Preferred Stock |
|
|
Series B Preferred Stock |
|
Gross Proceeds |
|
$ |
13,300 |
|
|
$ |
950 |
|
Less: |
|
|
|
|
|
|
|
|
Preferred stock issuance costs |
|
|
(844 |
) |
|
|
(60 |
) |
Plus: |
|
|
|
|
|
|
|
|
Accretion of carrying value to redemption value |
|
|
2,244 |
|
|
|
160 |
|
Preferred stock subject to possible redemption |
|
$ |
14,700 |
|
|
$ |
1,050 |
|
During December 2022,
the Company received redemption notices for all outstanding shares of Preferred Stock. The Preferred Stock was redeemed during
December 2022 at 105% of the $10.00 stated value of the Preferred Stock, or $15.8 million in the aggregate.
On June 24, 2022, the
Company closed on an offering (“the Offering”) with certain institutional investors (the “Investors”),
pursuant to which the Company issued and sold, in a private placement, 2,500,000 shares of the Company’s Series A Convertible
Redeemable Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”), and 500,000 shares of the
Company’s Series B Convertible Redeemable Preferred Stock, par value $0.001 per share (the “Series B Preferred Stock,”
and together with the Series A Preferred Stock, the “Preferred Stock”), at an offering price of $9.50 per share, representing
a 5% OID to the stated value of $10.00 per share, for gross proceeds of $28.5 million in the aggregate for the Offering, before
the deduction of fees and offering expenses. The shares of Preferred Stock were convertible, at a conversion price of $25.00 per
share (subject in certain circumstances to adjustments), into shares of the Company’s common stock, at the option of the
holders and, in certain circumstances, by the Company.
On August 5, 2022, an
amendment (the “Amendment”) to the Company’s Articles of Incorporation, as amended, to increase the Company’s
authorized shares of common stock from 8,000,000 to 24,000,000, as adjusted for the reverse split, was approved at a special meeting
of shareholders. The Series A Preferred Stock had the right to vote on such Amendment on an as-converted to common stock basis.
The shares of the Series B Preferred Stock were automatically voted in a manner that “mirrored” the proportions on
which the shares of common stock (excluding any shares of common stock that were not voted) and Series A Preferred Stock were voted
to increase the Authorized Shares. The Amendment required the approval of the majority of the votes associated with the Company’s
outstanding stock entitled to vote on the proposal. Because the Series B Preferred Stock were automatically and without further
action of the purchaser voted in a manner that “mirrored” the proportions on which the shares of common stock (excluding
any shares of common stock that were not voted) and Series A Preferred Stock were voted on the Amendment, abstentions by common
stockholders did not have any effect on the votes cast by the holders of the Series B Preferred Stock. The Certificates of Designation
for the Preferred Stock provides that the Preferred Stock have no voting rights other than the right to vote on the Amendment and
as a class on certain other specified matters, and, with respect to the Series B Certificate of Designation, the right to cast
2,500 votes per share of Series B Preferred Stock on the Amendment.
The holders of Preferred
Stock were entitled to dividends, on an as-if converted basis, equal to dividends actually paid, if any, on shares of common stock.
The Preferred Stock was convertible, at the option of the holders and, in certain circumstances, by the Company, into shares of
common stock at a conversion price of $25.00 per share. The holders of the Preferred Stock had the right to require the Company
to redeem their shares of preferred stock for cash at 105% of the stated value of such shares through September 22, 2022. The Company
had the option to redeem the Preferred Stock for cash at 105% of the stated value, subject to the holders’ rights to convert
the shares prior to such redemption.
The $28.5 million in
gross proceeds of the Offering was held in an escrow account, along with an additional $3.0 million deposited by the Company to
cover the aggregate OID as well as the additional amount that would be necessary to fund the 105% redemption price until the expiration
of the redemption period for the Preferred Stock, as applicable, subject to the earlier payment to redeeming holders. Upon expiration
of the redemption period, any proceeds remaining in the escrow account would be disbursed to the Company.
Since the Preferred
Stock had a redemption feature at the option of the holder, it was classified as temporary equity. The Series A Preferred Stock
and Series B Preferred Stock was recorded at redemption value of approximately $26.3 million and $5.2 million, respectively, as
calculated in the following table (in thousands):
|
|
Series A Preferred Stock |
|
|
Series B Preferred Stock |
|
Gross Proceeds |
|
$ |
23,750 |
|
|
$ |
4,750 |
|
Less: |
|
|
|
|
|
|
|
|
Preferred stock issuance costs |
|
|
(1,046 |
) |
|
|
(209 |
) |
Plus: |
|
|
|
|
|
|
|
|
Accretion of carrying value to redemption value |
|
|
3,546 |
|
|
|
709 |
|
Preferred stock subject to possible redemption |
|
$ |
26,250 |
|
|
$ |
5,250 |
|
During August 2022,
the Company received redemption notices for all outstanding shares of Preferred Stock. The Preferred Stock was redeemed during
August 2022 at 105% of the $10.00 stated value of the Preferred Stock, or $31.5 million in the aggregate.
|
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v3.23.3
REVENUES
|
9 Months Ended |
Sep. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
REVENUES |
NOTE 9 – REVENUES
Disaggregation of Net Revenues
The Company’s net product revenues
are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months Ended September 30, |
|
|
Nine
Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Zembrace® Symtouch® |
|
$ |
3,292 |
|
|
$ |
— |
|
|
$ |
3,292 |
|
|
$ |
— |
|
Tosymra® |
|
|
697 |
|
|
$ |
— |
|
|
$ |
697 |
|
|
$ |
— |
|
Total product revenues |
|
$ |
3,989 |
|
|
$ |
— |
|
|
$ |
3,989 |
|
|
$ |
— |
|
Gross-to-Net Sales Accruals
We record gross-to-net
sales accruals for chargebacks, rebates, sales and other discounts, and product returns, which are all customary to the pharmaceutical
industry.
Our provision for gross-to-net allowances
was $2.5 million at September 30, 2023, $0.7 million of which was recorded as a reduction to accounts receivable and $1.8 million
recorded as a component of accrued expenses.
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v3.23.3
ASSET PURCHASE AGREEMENT WITH UPSHER-SMITH
|
9 Months Ended |
Sep. 30, 2023 |
Business Combination and Asset Acquisition [Abstract] |
|
ASSET PURCHASE AGREEMENT WITH UPSHER-SMITH |
NOTE 10 – ASSET PURCHASE AGREEMENT WITH UPSHER-SMITH
On June 30, 2023, the Company completed the acquisition of certain assets from Upsher-Smith Laboratories LLC ("USL") related to Zembrace® SymTouch® (sumatriptan
injection) 3 mg (“Zembrace”) and Tosymra® (sumatriptan nasal spray) 10 mg (“Tosymra”) products (such
businesses collectively, the “Business”) and certain inventory related to the Business for an aggregate purchase price
of approximately $26.5 million, including certain deferred payments and subject to customary adjustments (such transaction, the
“USL Acquisition”).
On June 30, 2023, in
connection with the USL Acquisition, the Company and USL entered into a Transition Services Agreement (the “Transition Services
Agreement”), pursuant to which USL will provide certain transition services to the Company for base fees equal to $100,000
per month for the first six months, and $150,000 per months for the seventh through ninth months, plus additional monthly fees
for each service category totaling up to $150,000 per month.
The Company
has assumed certain obligations of Seller, including the payment of quarterly earn-out payments on annual net sales from the Business
in the U.S. as follows: for Tosymra, 4% for net sales of $0 to $30 million, 7% of net sales of $30 to $75 million; 9% for net sales of
$75 to $100 million; 12% for net sales of $100 to $150 million; and 15% for net sales greater than $150 million. Earn-out payments with
respect to Tosymra are payable until the expiration or termination of the product’s Orange Book listed patent(s) with respect to
the United States or, outside the United States, the expiration of the last valid claim covering the product in the relevant country of
the territory. For Zembrace, earn-out payments on annual net sales in the U.S. are 3% for net sales of $0 to $30 million, 6% of net sales
of $30 to $75 million; 12% for net sales of $75 to $100 million; 16% for net sales of greater than $100 million. Such earn-out payments
are payable until July 19, 2025. Upon the entry of a generic version of the relevant product, the applicable earn-out rates shall be reduced
by 90% percent with respect to Zembrace, and by 66.7% percent for Tosymra. Prior to Purchaser or a licensee filing an application for
marketing authorization for either of the products in a permitted country outside the U.S., the parties will negotiate in good faith the
earn-out payment rates annual net sales tiers that will apply for such country, based on the market opportunity for the product in such
country. If the parties fail to agree, then the earn-out payment rates and annual net sales tiers described above will apply.
In addition,
the Company has assumed the obligation to pay an additional 3% royalty on net sales of Tosymra, plus an additional 3% if a patent containing
certain claims related to Tosymra issues in the U.S., for 15 years from the first commercial sale of Tosymra in the applicable country
or for as long as the manufacture, use or sale of Tosymra in such country is covered by a valid claim of a licensed patent, and up to
$15 million per Tosymra product on the achievement of sales milestones.
As
consideration for acquisition of the Business and certain product-related inventories, the Company paid approximately $23.5
million in cash upfront. On the earlier of March
2024 and the completion of the transition services to be provided by USL, as described above, the Company agreed to pay an additional
deferred payment of $3.0
million in cash, which is included in Accrued expenses and other current liabilities on
the accompanying balance sheet. The following table summarizes the components of the purchase consideration (in thousands):
Preliminary purchase consideration |
|
Amount |
|
Closing cash consideration |
|
$ |
22,174 |
|
Inventory adjustment payment liability |
|
|
1,348 |
|
Deferred payment liability |
|
|
3,000 |
|
Purchase price to be allocated |
|
$ |
26,522 |
|
The USL Acquisition
was accounted for as a business combination using the acquisition method, in accordance with the provisions of ASC 805, Business
Combinations and ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. The tangible
and intangible assets acquired were recorded at their estimated fair values on the acquisition date, and the difference between
the fair value of these assets and the purchase price has been recorded as goodwill. The purchase price allocation is based upon
preliminary valuations and estimates and assumptions which are subject to change. As the Company receives additional information
about facts and circumstances that existed at the acquisition date, the fair values of the acquired inventory and intangible assets
may be adjusted, with the offset recorded to goodwill. The acquisition-date fair value analyses will be finalized as soon as practicable,
but in no event later than one year after the acquisition date.
The following table
represents the preliminary allocation of the purchase price to the assets acquired by the Company in the USL Acquisition recognized
in the Company’s consolidated balance sheets (in thousands):
Preliminary purchase price allocation |
|
Amount |
|
Inventory |
|
$ |
13,700 |
|
Prepaid expenses and other |
|
|
1,757 |
|
Intangible assets, net |
|
|
10,100 |
|
Goodwill |
|
|
965 |
|
Fair value of assets acquired |
|
$ |
26,522 |
|
The acquired inventory
consists of USL’s raw materials, semi-finished goods, and finished goods inventory as of the Closing date. The fair value
was determined based on the estimated selling price of the inventory, less the estimated total costs to complete, disposal effort
and holding costs.
The $1.0 million of
goodwill arising from the USL Acquisition represents expected synergies from combining operations, intangible assets that do not
qualify for separate recognition, and other factors, of which all is expected to be deductible for tax purposes, subject to any
limitations.
Intangible assets eligible
for recognition separate from goodwill were those that satisfied either the contractual or legal criterion or the separability
criterion in the accounting guidance. The identifiable intangible assets acquired and their estimated useful lives for amortization
are as follows (in thousands):
|
|
Fair Value |
|
|
Useful Life
(years) |
|
Developed technology - Tosymra |
|
$ |
3,400 |
|
|
|
9 |
|
Developed technology - Zembrace |
|
|
6,700 |
|
|
|
14 |
|
Total |
|
$ |
10,100 |
|
|
|
|
|
The developed technology
intangible assets related to Zembrace and Tosymra includes the value associated with the acquired patents, customer relationships,
and trademarks and trade names associated with the technology. The developed technology intangible assets were valued as composite
assets under the premise that each asset is reliant on one another to generate cash flow, is not considered separable from the
technology, and are assumed to have similar useful lives. The composite intangible assets were valued using a multi-period excess
earnings method and are being amortized over their estimated useful lives using the straight-line method of amortization. The key
assumptions used in estimating the fair values of intangible assets include forecasted financial information, the weighted average
cost of capital, customer retention rates, and certain other assumptions.
The fair values assigned
to the assets acquired are based on reasonable assumptions and estimates that market participants would use. Actual results may
differ from these estimates and assumptions.
Supplemental Pro Forma Information
The following unaudited
pro forma consolidated financial information reflects the results of operations of the Company for the three and nine months ended
September 30, 2023 and 2022 as if the USL Acquisition had occurred as of January 1, 2022 and gives effect to transactions that
are directly attributable to the acquisition. These amounts are based on financial information of the acquired business and are
not necessarily indicative of what the Company’s operating results would have been had the acquisition taken place on the
date presented, nor is it indicative of the Company’s future operating results.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Net Product Sales |
|
$ |
3,989 |
|
|
$ |
3,635 |
|
|
$ |
11,610 |
|
|
$ |
7,612 |
|
Net Loss |
|
$ |
(27,072 |
) |
|
$ |
(33,698 |
) |
|
$ |
(91,252 |
) |
|
$ |
(95,073 |
) |
The pro forma information
for all periods presented include additional amortization expense related to the fair value of the acquired intangible assets as
if such assets were acquired on January 1, 2022. The pro forma financial information for the three and nine months ended September
30, 2022 also reflects an increase in Cost of Sales related to the preliminary acquisition-date fair value adjustment to inventory.
This adjustment is not reflected in the three and nine months ended September 30, 2023 as the acquired inventory is expected to
be sold within one year from the acquisition date.
As described above,
in connection with the USL Acquisition, the Company and USL entered into a Transition Services Agreement with the Seller related
to providing ongoing services associated with the assets acquired, such as procuring and selling migraine therapy products, providing
accounting and billing services and collecting accounts receivable and paying trade payables. The Seller collected and will continue
to collect cash on behalf of Tonix for revenue generated by sales of the assets acquired from June 30, 2023 through the transition
period and the Seller is obligated to transfer cash generated by such sales to the Buyer.
The
amount due to USL for reimbursement of services performed under the transition services agreement was $498,000
as of September 30, 2023. The transition service fees were netted against the receivables collected of $4,784,000
and liabilities paid of $2,724,000
on behalf of the Company with the net amount due to the Company of $1,562,000
recorded within receivables, net on the condensed consolidated balance sheet as of September 30, 2023.
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v3.23.3
ASSET PURCHASE AGREEMENT WITH HEALION
|
9 Months Ended |
Sep. 30, 2023 |
Asset Purchase Agreement With Healion |
|
ASSET PURCHASE AGREEMENT WITH HEALION |
NOTE 11 – ASSET PURCHASE AGREEMENT
WITH HEALION
On
February 2, 2023, the Company entered into an asset purchase agreement (the “Healion Asset Purchase Agreement”) with Healion
Bio Inc., (“Healion”) pursuant to which the Company acquired all the pre-clinical infectious disease assets of Healion, including
its portfolio of next-generation antiviral technology assets. Healion’s drug portfolio includes a class of broad-spectrum small
molecule oral antiviral drug candidates with a novel host-directed mechanism of action, including TNX-3900, formerly known as HB-121.
As consideration for entering into the Healion Asset Purchase Agreement, the Company paid $1.2
million to Healion. Because the Healion intellectual property was acquired prior to U.S. Food and Drug Administration (FDA) approval,
the cash consideration totaling $1.2
million, was expensed as research and development costs since there is no alternative future use and the acquired intellectual
property does not constitute a business.
|
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v3.23.3
LICENSE AGREEMENT WITH CURIA
|
9 Months Ended |
Sep. 30, 2023 |
License Agreement With Curia |
|
LICENSE AGREEMENT WITH CURIA |
NOTE 12 – LICENSE AGREEMENT WITH CURIA
On December 12, 2022,
the Company entered into an exclusive license agreement with Curia for the development of three humanized murine mAbs for the treatment
or prophylaxis of SARS-CoV-2 infection. We believe that the licensing of these mAbs strengthens our pipeline of next-generation
therapeutics to treat COVID-19, which is caused by SARS-CoV-2. As consideration for entering into the License Agreement, we paid
a license fee of approximately $0.4 million to Curia. The License Agreement also provides for single-digit royalties and contingent
milestone payments. As of September 30, 2023, other than the upfront fee, no payments have been accrued or paid in relation to
this agreement.
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v3.23.3
LICENSE AGREEMENT WITH UNIVERSITY OF ALBERTA
|
9 Months Ended |
Sep. 30, 2023 |
License Agreement With University Of Alberta |
|
LICENSE AGREEMENT WITH UNIVERSITY OF ALBERTA |
NOTE 13 – LICENSE AGREEMENT WITH UNIVERSITY OF ALBERTA
On May 18, 2022, the Company entered into an exclusive License Agreement with the University of Alberta focused on identifying and testing broad-spectrum antiviral drugs against future variants of SARS-CoV-2 and other emerging viruses. As consideration for entering into the License Agreement, Tonix paid a low-five digit license fee to University of Alberta. The License Agreement also provides for single-digit royalties and contingent milestone payments. As of September 30, 2023, other than the upfront fee, no milestone payments have been accrued or paid in relation to this agreement.
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v3.23.3
LICENSE AGREEMENTS WITH COLUMBIA UNIVERSITY
|
9 Months Ended |
Sep. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
LICENSE AGREEMENTS WITH COLUMBIA UNIVERSITY |
NOTE
14 – LICENSE AGREEMENTS WITH COLUMBIA UNIVERSITY
On February 13, 2023,
Tonix exercised an option to obtain an exclusive license from Columbia for the development of a portfolio of both fully human and
murine mAbs for the treatment or prophylaxis of SARS-CoV-2 infection, including our TNX-3600 and TNX-4100 product candidates, respectively.
The licensed mAbs were developed as part of a research collaboration and option agreement between Tonix and Columbia.
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v3.23.3
SALE OF COMMON STOCK
|
9 Months Ended |
Sep. 30, 2023 |
Sale Of Common Stock |
|
SALE OF COMMON STOCK |
NOTE 15 – SALE OF COMMON STOCK
July 2023 Financing
On July 27, 2023, the
Company sold 2,530,000 shares of common stock; pre-funded warrants
to purchase up to 4,470,000 shares of common stock, and accompanying common warrants to purchase up to 7,000,000 shares of common
stock with an exercise price of $1.00 per share in a public offering that closed on August 1, 2023. The offering price per share of common stock and accompanying common warrant was
$1.00, and the offering price per share of pre-funded warrant and accompanying common warrant was $0.9999.
The Company incurred offering expenses of approximately $0.7 million, including placement agent fees of approximately
$0.5 million. The Company received net proceeds of approximately $6.3 million, after deducting the underwriting discount and other
offering expenses.
2022 Lincoln Park Transaction
On August 16, 2022, the Company
entered into an equity line of credit with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park
agreed to purchase up to $50,000,000 of the Company’s common stock (subject to certain limitations) from time to time. The Company
filed with the SEC a registration statement to register for resale under the Securities Act the shares that have been or may be issued
to Lincoln Park under the 2022 Purchase Agreement. The Company issued 100,000 shares of common stock to Lincoln Park as consideration
for its commitment to purchase shares of the Company’s common stock. The commitment shares were valued at $1,000,000 and recorded
as an addition to equity for the issuance of the common stock and treated as a reduction to equity as a cost of capital to be raised under
the equity line of credit.
During the three and nine
months ended September 30, 2023, the Company sold 0 and 0.1 million shares, respectively, of common stock under the equity line of credit
with Lincoln Park, for net proceeds of approximately $0 and $0.4 million, respectively.
During the nine months ended
September 30, 2022, no shares of common stock were sold under the equity line of credit.
Purchase Agreement with Lincoln Park
On December 3, 2021,
the Company entered into a purchase agreement (the “Purchase Agreement with Lincoln Park”) and a registration rights
agreement (the “Lincoln Park Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”).
Pursuant to the terms of the Purchase Agreement with Lincoln Park, Lincoln Park agreed to purchase from the Company up to $80,000,000
of the Company’s common stock (subject to certain limitations) from time to time during the term of the Purchase Agreement
with Lincoln Park. Pursuant to the terms of the Lincoln Park Registration Rights Agreement, the Company filed with the SEC a registration
statement to register for resale under the Securities Act the shares that have been or may be issued to Lincoln Park under the
Purchase Agreement with Lincoln Park.
Pursuant to the terms
of the Purchase Agreement with Lincoln Park, at the time the Company signed the Purchase Agreement with Lincoln Park and the Lincoln
Park Registration Rights Agreement, the Company issued 14,546 shares of common stock to Lincoln Park as consideration for its commitment
to purchase shares of our common stock under the Purchase Agreement with Lincoln Park. The commitment shares were valued at $1.6
million and recorded as an addition to equity for the issuance of the common stock and treated as a reduction to equity as a cost
of capital to be raised under the Purchase Agreement with Lincoln Park.
During the nine months
ended September 30, 2022, the Company sold 0.5 million shares of common stock under the Purchase Agreement with Lincoln Park, for
net proceeds of approximately $8.7 million. No sales occurred in 2023.
Under applicable rules
of the NASDAQ Global Market, the Company could not issue or sell more than 19.99% of the shares of its common stock outstanding
immediately prior to the execution of the Purchase Agreement with Lincoln Park (approximately 0.5 million shares) to Lincoln Park
under the Purchase Agreement with Lincoln Park without stockholder approval, unless the average price of all applicable sales of
its common stock to Lincoln Park under the Purchase Agreement with Lincoln Park equals or exceeds a threshold amount. As the Company
has issued approximately 0.4 million shares to Lincoln Park, by September 30, 2022, under the Purchase Agreement with Lincoln Park
at less than the threshold amount, the Company will not sell any additional shares under the Purchase Agreement with Lincoln Park
without shareholder approval.
At-the-Market Offerings
On April 8, 2020, the Company entered into a sales agreement
with AGP pursuant to which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $320.0
million in at-the-market offerings (“ATM”) sales at prevailing market prices at the time of the sale, and, as a result, prices
will vary. AGP receives a 3% commission on each ATM sale under the Sales Agreement.
During
the three and nine months ended September 30, 2023, the Company sold approximately 0 and 1.0 million shares, respectively, of
common stock under the Sales Agreement, for net proceeds of approximately $0 million and $3.0 million, respectively. During the
nine months ended September 30, 2022, the Company sold approximately 5.5 million shares of common stock under the Sales Agreement,
for net proceeds of approximately $76.2 million.
Stock Repurchases
During the first quarter
of 2023, the Company has repurchased 2,512,044 of its shares of common stock outstanding under the 2022 share repurchase program
for up to $12.5 million at prices ranging from $2.75 to $8.61 per share for a gross aggregate cost of approximately $12.5 million.
In addition, the Company incurred expenses of $0.3 million.
In
January 2023, the Board of Directors approved a new 2023 share repurchase program pursuant to which the Company
may repurchase up to an additional $12.5
million in value of its outstanding common stock from time to time on the open market and in privately negotiated transactions
subject to market conditions, share price and other factors. During the first quarter of 2023, the Company has repurchased 160,000
of our shares of common stock outstanding under the new 2023 share repurchase program at $7.12
per share for a gross aggregate cost of $1.1
million. No additional repurchases have occurred since the first quarter of 2023.
The timing and amount
of any shares repurchased will be determined based on the Company’s evaluation of market conditions and other factors
and the New Share Repurchase Program may be discontinued or suspended at any time. Repurchases will be made
in accordance with the rules and regulations promulgated by the Securities and Exchange Commission and certain other legal requirements
to which the Company may be subject. Repurchases may be made, in part, under a Rule 10b5-1 plan, which allows stock repurchases when
the Company might otherwise be precluded from doing so.
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v3.23.3
STOCK-BASED COMPENSATION
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
STOCK-BASED COMPENSATION |
NOTE
16 – STOCK-BASED COMPENSATION
On May 1, 2020, the
Company’s stockholders approved the Tonix Pharmaceuticals Holding Corp. Amended and Restated 2020 Stock Incentive Plan (“Amended
and Restated 2020 Plan”).
Under the terms of the
Amended and Restated 2020 Plan, the Company may issue (1) stock options (incentive and nonstatutory), (2) restricted stock, (3)
stock appreciation rights (“SARs”), (4) RSUs, (5) other stock-based awards, and (6) cash-based awards. The Amended
and Restated 2020 Plan initially provided for the issuance of up to 50,000 shares of common stock, which amount will be increased
to the extent that awards granted under the Plans are forfeited, expire or are settled for cash (except as otherwise provided in
the Amended and Restated 2020 Plan). In addition, the Amended and Restated 2020 Plan contains an “evergreen provision”
providing for an annual increase in the number of shares of our common stock available for issuance under the Amended and Restated
2020 Plan on January 1 of each year for a period of ten years, commencing on January 1, 2021 and ending on (and including) January
1, 2030, in an amount equal to the difference between (x) twenty percent (20%) of the total number of shares of common stock outstanding
on December 31st of the preceding calendar year, and (y) the total number of shares of common stock reserved under the Amended
and Restated 2020 Plan on December 31st of such preceding calendar year (including shares subject to outstanding awards,
issued pursuant to awards or available for future awards). The Board of Directors determines the exercise price, vesting and expiration
period of the grants under the Amended and Restated 2020 Plan. However, the exercise price of an incentive stock option may not
be less than 110% of fair value of the common stock at the date of the grant for a 10% or more shareholder and 100% of fair value
for a grantee who is not a 10% shareholder. The fair value of the common stock is determined based on quoted market price or in
absence of such quoted market price, by the Board of Directors in good faith. Additionally, the expiration period of grants under
the Amended and Restated 2020 Plan may not be more than ten years. As of September 30, 2023, 1,062,874 options were available for
future grants under the Amended and Restated 2020 Plan.
General
A summary of the stock
option activity and related information for the Plans for the nine months ended September 30, 2023 is as follows:
|
|
Shares |
|
|
Weighted-
Average Exercise Price |
|
|
Weighted-
Average Remaining Contractual
Term |
|
|
Aggregate
Intrinsic
Value |
|
Outstanding at December 31, 2022 |
|
|
392,643 |
|
|
$ |
334.08 |
|
|
|
8.70 |
|
|
$ |
— |
|
Grants |
|
|
1,019,130 |
|
|
|
4.64 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
Forfeitures or expirations |
|
|
(27,509 |
) |
|
|
453.81 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2023 |
|
|
1,384,264 |
|
|
$ |
89.09 |
|
|
|
9.01 |
|
|
$ |
— |
|
Exercisable at September 30, 2023 |
|
|
248,656 |
|
|
$ |
392.48 |
|
|
|
7.78 |
|
|
$ |
|
|
The weighted average
fair value of options granted during the three and nine months ended September 2023 was $0.84 per share and $3.99 per share, respectively.
The weighted average fair value of options granted during the three and nine months ended September 2022 was $0 per share and $32.81
per share, respectively.
The Company measures
the fair value of stock options on the date of grant, based on the Black Scholes option pricing model using certain assumptions
discussed below, and the closing market price of the Company’s common stock on the date of the grant. The fair value of the
award is measured on the grant date. One-third of most stock options granted pursuant to the Plans vest 12 months from the date
of grant and 1/36th each month thereafter for 24 months and expire ten years from the date of grant. In addition, the Company issues
options to directors which vest over a period. The Company also issues premium options to executive officers which have
an exercise price greater than the grant date fair value and has issued performance-based options which vest when target parameters
are met or probable of being met, subject in each case to a one year minimum service period prior to vesting. Stock-based compensation
expense related to awards is amortized over the applicable service period using the straight-line method.
The assumptions used
in the valuation of stock options granted during the nine months ended September 30, 2023 and 2022 were as follows:
|
|
Nine Months Ended
September 30, 2023 |
|
|
Nine Months Ended
September 30, 2022 |
|
Risk-free interest rate |
|
|
3.42% to 4.35 |
% |
|
|
1.67% to 3.05 |
% |
Expected term of option |
|
|
5.0 to 10 years |
|
|
|
5.5 to 10 years |
|
Expected stock price volatility |
|
|
122.19% - 142.72 |
% |
|
|
120.32% - 133.22 |
% |
Expected dividend yield |
|
|
0.0 |
|
|
|
0.0 |
|
The risk-free interest
rate is based on the yield of Daily U.S. Treasury Yield Curve Rates with terms equal to the expected term of the options as of
the grant date. The expected term of options is determined using the simplified method, as provided in an SEC Staff Accounting
Bulletin, and the expected stock price volatility is based on the Company’ historical stock price volatility.
Stock-based compensation
expense relating to options granted of $2.1 million, of which $1.4 million and $0.7 million, related to General and Administration
and Research and Development, respectively was recognized for the quarter ended September 30, 2023. Stock-based compensation
expense relating to options granted of $2.7 million, of which $2.0 million and $0.7 million, related to General and Administration
and Research and Development, respectively was recognized for the quarter ended September 30, 2022.
Stock-based compensation
expense relating to options granted of $7.2 million, of which $5.0 million and $2.2 million, related to General and Administration
and Research and Development, respectively was recognized for the nine-month period ended September 30, 2023. Stock-based compensation
expense relating to options granted of $8.1 million, of which $5.9 million and $2.2 million, related to General and Administration
and Research and Development, respectively was recognized for the nine-month period ended September 30, 2022.
As of September 30,
2023, the Company had approximately $8.2 million of total unrecognized compensation cost related to non-vested awards granted under
the Plans, which the Company expects to recognize over a weighted average period of 1.74 years.
Employee Stock Purchase Plans
On May 6, 2022, the
Company’s stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2022 Employee Stock Purchase Plan. (the "2022 ESPP"), which was replaced by the Tonix Pharmaceuticals Holdings Corp. 2023 Employee Stock Purchase
Plan (the “2023 ESPP”, and together with the 2022 ESPP, the “ESPP Plans”), which was approved by the Company's stockholders on May 5, 2023.
The 2023 ESPP allows
eligible employees to purchase up to an aggregate of 800,000 shares of the Company’s common stock. Under the 2023
ESPP, on the first day of each offering period, each eligible employee for that offering period has the option to enroll for that
offering period, which allows the eligible employees to purchase shares of the Company’s common stock at the end of the offering
period. Each offering period under the 2023 ESPP is for six months, which can be modified from time-to-time. Subject to limitations,
each participant will be permitted to purchase a number of shares determined by dividing the employee’s accumulated
payroll deductions for the offering period by the applicable purchase price, which is equal to 85 percent of the fair
market value of our common stock at the beginning or end of each offering period, whichever is less. A participant must designate
in his or her enrollment package the percentage (if any) of compensation to be deducted during that offering period for the purchase
of stock under the 2023 ESPP, subject to the statutory limit under the Code. As of September 30, 2023, 800,000 shares were available
for future sales under the 2023 ESPP.
The
ESPP Plans are considered compensatory plans with the related compensation cost expensed over the six-month offering period. For the
three months ended September 30, 2023 and 2022, $34,000
and $46,000,
respectively, was expensed. For the nine months ended September 30, 2023 and 2022, $34,000
and $46,000,
respectively were expensed. In January 2022, 646
shares that were purchased as of December 31, 2021, under the 2020 ESPP, were issued. Accordingly, during the first quarter of 2022,
approximately $40,000
of employee payroll deductions accumulated at December 31, 2021, related to acquiring such shares, was transferred from accrued
expenses to additional paid in capital. The remaining $30,000
was returned to the employees. In January 2023, 14,999
shares that were purchased as of December 31, 2022, under the 2022 ESPP, were issued. Accordingly, during the first quarter of 2023,
approximately $29,000
of employee payroll deductions accumulated at December 31, 2022, related to acquiring such shares, was transferred from accrued
expenses to additional paid in capital. The remaining $14,000
was returned to the employees. As of September 30, 2023, approximately $32,000
of employee payroll deductions have accumulated and have been recorded in accrued expenses.
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v3.23.3
STOCK WARRANTS
|
9 Months Ended |
Sep. 30, 2023 |
Stock Warrants |
|
STOCK WARRANTS |
NOTE 17 – STOCK WARRANTS
The following table
summarizes information with respect to outstanding warrants to purchase common stock of the Company at September 30, 2023:
Exercise |
|
|
Number |
|
|
Expiration |
Price |
|
|
Outstanding |
|
|
Date |
$ |
1.00 |
|
|
|
7,000,000 |
|
|
August 2028 |
$ |
100.00 |
|
|
|
125 |
|
|
November 2024 |
$ |
114.00 |
|
|
|
618 |
|
|
February 2025 |
$ |
7,000.00 |
|
|
|
2,453 |
|
|
December 2023 |
|
|
|
|
|
7,003,196 |
|
|
|
In connection with the
July 2023 Financing, the Company issued 4,470,000 prefunded warrants with an exercise price of $0.0001. All prefunded warrants were exercised during the quarter ended September 30, 2023. Additionally, the Company issued warrants to purchase up to an aggregate of 7,000,000 shares of the Company's common
stock. The warrants are exercisable at $1.00 per share, expire five years from the date of issuance.
No warrants were exercised
during either of the nine months ended September 30, 2023, and 2022.
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v3.23.3
LEASES
|
9 Months Ended |
Sep. 30, 2023 |
Leases |
|
LEASES |
NOTE 18 – LEASES
The Company has various
operating lease agreements, which are primarily for office space. These agreements frequently include one or more renewal options
and require the Company to pay for utilities, taxes, insurance and maintenance expense. No lease agreement imposes a restriction
on the Company’s ability to engage in financing transactions or enter into further lease agreements. At September 30, 2023,
the Company has right-of-use assets of $1.1 million and a total lease liability for operating leases of $1.1 million of which $0.7
million is included in long-term lease liabilities and $0.4 million is included in current lease liabilities.
At September 30, 2023,
future minimum lease payments for operating leases with non-cancelable terms of more than one year were as follows (in thousands):
Year Ending December 31, |
|
|
|
|
|
2023 |
|
|
$ |
107 |
|
2024 |
|
|
|
460 |
|
2025 |
|
|
|
299 |
|
2026 |
|
|
|
142 |
|
2027 and beyond |
|
|
|
246 |
|
|
|
|
|
1,254 |
|
Included interest |
|
|
|
(104 |
) |
|
|
|
$ |
1,150 |
|
During the nine months
ended September 30, 2023, the Company entered into new operating leases and lease amendments, resulting in the Company recognizing
an additional operating lease liability of approximately $898,000 based on the present value of the minimum rental payments. The
Company also recognized a corresponding increase to ROU assets of approximately $898,000, which represents a non-cash operating activity.
During the nine months
ended September 30, 2022, the Company entered into new operating leases and lease amendments, resulting in the Company recognizing
an additional operating lease liability of approximately $386,000 based on the present value of the minimum rental payments. The
Company also recognized a corresponding increase to ROU assets of approximately $386,000, which represents a non-cash operating activity.
Other information related to leases is as follows:
Operating lease expense
was $0.1 million for both three months ended September 30, 2023 and 2022.
Operating lease expense
was $0.4 million for both the nine-months ended September 30, 2023 and 2022.
Other information related to leases is as follows:
Cash paid for amounts included in the measurement of lease liabilities: |
|
Nine
Months Ended
September 30, 2023 |
|
|
Nine
Months Ended
September 30, 2022 |
|
Operating cash flow from operating leases (in thousands) |
|
$ |
434 |
|
|
$ |
447 |
|
|
|
|
|
|
|
|
|
|
Weighted Average Remaining Lease Term |
|
|
|
|
|
|
|
|
Operating leases |
|
|
3.50 years |
|
|
|
2.33 years |
|
|
|
|
|
|
|
|
|
|
Weighted Average Discount Rate |
|
|
|
|
|
|
|
|
Operating leases |
|
|
4.63 |
% |
|
|
2.26 |
% |
|
X |
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v3.23.3
COMMITMENTS
|
9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS |
NOTE 19 – COMMITMENTS
Contractual agreements
The Company has entered
into contracts with various contract research organizations with outstanding commitments aggregating approximately $33.4 million
at September 30, 2023 for future work to be performed.
Defined contribution plan
The Company has a qualified
defined contribution plan (the “401(k) Plan”) pursuant to Section 401(k) of the Code, whereby all eligible employees
may participate. Participants may elect to defer a percentage of their annual pretax compensation to the 401(k) Plan, subject
to defined limitations. The Company is required to make contributions to the 401(k) Plan equal to 100 percent of each participant’s
pretax contributions of up to six percent of his or her eligible compensation, and the Company is also required to make a contribution
equal to three percent of each participant’s salary, on an annual basis, subject to limitations under the Code. The Company
charged operations $200,000 and $700,000 for the three and nine months ended September 30, 2023, respectively, and $122,000 and
$428,000 for the three and nine months ended September 30, 2022, respectively, for contributions under the 401(k) Plan.
|
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v3.23.3
SUBSEQUENT EVENTS
|
9 Months Ended |
Sep. 30, 2023 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE 20 – SUBSEQUENT EVENTS
On
September 28, 2023, the Company sold 4,050,000
shares of common stock; pre-funded warrants to purchase up to 4,950,000
shares of common stock, and accompanying Series A warrants to purchase up to 9,000,000
shares of common stock with an exercise price of $0.50
per share and expiring five
years from date of issuance, and Series B warrants to purchase up to 9,000,000
shares of common stock with an exercise price of $0.50
per share and expiring one
year from date of issuance in a public offering, which closed on October 3, 2023. The offering price per share of common
stock and accompanying warrants was $0.50,
and the offering price per share of pre-funded warrant and accompanying warrants was $0.4999.
The Company incurred offering expenses of approximately $0.5 million, including placement agent fees of approximately
$0.3 million. The Company received net proceeds of approximately $4.0 million, after deducting the underwriting discount and other
offering expenses.
On
October 17, 2023, the Company received a letter from the Listing Qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”)
indicating that, the Company no longer met the requirement to maintain a minimum bid price of $1
per share, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).
In
accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided a period of 180
calendar days, or until April 14, 2024, in which to regain compliance with the Minimum Bid Price Requirement. In the event that the Company does not regain compliance
within this 180-day
period, the Company may be eligible to seek an additional compliance period of 180
calendar days if it meets the continued listing requirement for market value of publicly held shares and all other initial listing
standards for the Nasdaq Global Market, with the exception of the Minimum Bid Price Requirement, and provides written notice to Nasdaq
of its intent to cure the deficiency during this second compliance period, by effecting a reverse stock split, if necessary. However,
if it appears to the Nasdaq Staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible,
Nasdaq will provide notice to the Company that its common stock will be subject to delisting.
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v3.23.3
SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Interim financial statements |
Interim financial statements
The unaudited condensed
consolidated interim financial statements of the Company have been prepared in accordance with accounting principles generally
accepted in the United States (“GAAP”) for interim financial information and the instructions to Form 10-Q and Article
8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial
statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a
fair presentation have been included.
The condensed consolidated
balance sheet as of December 31, 2022 contained herein has been derived from audited financial statements.
Operating results for
the three and nine months ended September 30, 2023 are not necessarily indicative of results that may be expected for the year
ending December 31, 2023. These condensed consolidated financial statements should be read in conjunction with the audited consolidated
financial statements and notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form
10-K, filed with the Securities and Exchange Commission (“SEC”) on March 13, 2023.
|
Reverse Stock Split |
Reverse Stock Split
On May 9, 2023, the
Company filed a Certificate of Change with the Nevada Secretary of State, effective May 10, 2023. Pursuant to the Certificate of
Change, the Company effected a 1-for-6.25 reverse stock split of its issued and outstanding shares of common stock. The Company
accounted for the reverse stock split on a retrospective basis pursuant to ASC 260, Earnings Per Share. All authorized, issued
and outstanding common stock, common stock warrants, stock option awards, exercise prices and per share data have been adjusted
in these condensed consolidated financial statements, on a retrospective basis, to reflect the reverse stock split for all periods
presented. Authorized preferred stock was not adjusted because of the reverse stock split.
|
Risks and uncertainties |
Risks and uncertainties
The Company’s primary efforts are devoted to conducting research
and development of innovative pharmaceutical and biological products to address public health challenges. The Company has experienced
net losses and negative cash flows from operations since inception and expects these conditions to continue for the foreseeable future.
Further, the Company now has commercial products available for sale, and generates revenue from the sale of its Zembrace® SymTouch®
and Tosymra® products, with no assurance that the Company will be able to generate sufficient cash flow to fund operations from its
commercial products or products in development if and when approved. In addition, there can be no assurance that the Company’s research
and development will be successfully completed or that any product will be approved or commercially viable.
|
Use of estimates |
Use of estimates
The preparation of financial
statements in accordance with Generally Accepted Accounting Principles (“GAAP”) requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities
at the date of the financial statements, and the reported amounts of expenses during the reporting period. Actual results could
differ from those estimates. Significant estimates include, but are not limited to, provisions for product returns, coupons, rebates,
chargebacks, discounts, allowances, inventory realization, the assumptions used in the fair value of stock-based compensation and
other equity instruments, the percent of completion of research and development contracts, fair value estimates for assets acquired
in business combinations, and assessment of useful lives of acquired intangible assets.
|
Business Combinations |
Business Combinations
The Company accounts
for business combinations in accordance with the provisions of ASC 805, Business Combinations and ASU No. 2017-01, Business Combinations
(Topic 805): Clarifying the Definition of a Business. Business combinations are accounted for using the acquisition method, whereby
the consideration transferred is allocated to the net assets acquired based on their respective fair values measured on the acquisition
date. The difference between the fair value of these assets and the purchase price is recorded as goodwill. Transaction costs other
than those associated with the issue of debt or equity securities, and other direct costs of a business combination are not considered
part of the business acquisition transaction and are expensed as incurred.
|
Segment Information and Concentrations |
Segment Information and Concentrations
Operating segments are
defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating
decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views
its operations and manages its business in one segment.
The Company has two
products that each accounted for more than 10% of total revenues during the three and nine months ended September 30, 2023. These
products collectively accounted for 100% of revenues during the three and nine months ended September 30, 2023.
As
of September 30, 2023, accounts receivable from four customers accounted for 25%, 23%, 19%
and 15%
of total accounts receivable. For the three and nine months ended September 30, 2023, revenues from four customers accounted
for 25%, 21%, 18%
and 14%
of net product revenues, respectively. As of September 30, 2022, and for the three and nine months ended September 30, 2022,
the Company had no commercialized products and therefore had no accounts receivables or revenues.
|
Cash, Cash Equivalents and Restricted Cash |
Cash, Cash Equivalents and Restricted Cash
The Company considers
cash equivalents to be those investments which are highly liquid, readily convertible to cash and have an original maturity of
three months or less when purchased. At September 30, 2023 and December 31, 2022, cash equivalents, which consisted of money market
funds, amounted to $3.7 million and $116.3 million, respectively. Restricted cash, which is included in Other non-current assets
on the condensed consolidated balance sheet, at both September 30, 2023, and December 31, 2022, of approximately $244,000 and $241,000,
respectively, collateralizes a letter of credit issued in connection with the lease of office space in Chatham, New Jersey and
New York, New York (see Note 18). In addition, the Company has $758,000 of restricted cash held by vendors in escrow accounts for patient support services as of September 30, 2023.
The following table
provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets
that sum to the total of the same amounts shown in the condensed consolidated statement of cash flows:
|
|
September 30,
2023 |
|
|
September 30,
2022 |
|
|
|
(in thousands) |
|
Cash and cash equivalents |
|
$ |
6,914 |
|
|
$ |
139,978 |
|
Restricted cash |
|
|
1,002 |
|
|
|
240 |
|
Total |
|
$ |
7,916 |
|
|
$ |
140,218 |
|
|
Accounts Receivable, net |
Accounts Receivable, net
Accounts receivable consists of amounts due from our wholesale and other third-party distributors and pharmacies and have standard
payment terms that generally require payment within 30 to 90 days. For certain customers, the accounts receivable for the customer
is net of prompt payment or specialty pharmacy discounts. We do not adjust our receivables for the effects of a significant financing
component at contract inception if we expect to collect the receivables in one year or less from the time of sale. We provide reserves
against accounts receivable for estimated losses that may result from a customer’s inability to pay. Amounts determined to
be uncollectible are charged or written-off against the reserve. However, during the period covered by the Transition Services
Agreement, the Seller has agreed to collect the accounts receivable on behalf of the Company and net settle within 45 days from
each month-end. See note 10 for further details. The Company had no accounts receivable as of any prior period presented other than as of September 30, 2023.
As of September
30, 2023, the Company did not have an allowance for doubtful accounts. An allowance for doubtful accounts is determined based on
the financial condition and creditworthiness of customers and the Company considers economic factors and events or trends expected to
affect future collections experience. Any allowance would reduce the net receivables to the amount that is expected to be collected. The
payment history of the Company’s customers will be considered in future assessments of collectability as these patterns are established
over a longer period.
|
Concentration of Credit Risk |
Concentration of Credit Risk
Financial instruments
that potentially subject us to concentrations of credit risk include cash and cash equivalents, and accounts receivable. We attempt
to minimize the risks related to cash and cash equivalents by investing in a broad and diverse range of financial instruments,
and we have established guidelines related to credit ratings and maturities intended to safeguard principal balances and maintain
liquidity. Concentrations of credit risk with respect to receivables, which are typically unsecured, are somewhat mitigated due
to the wide variety of customers using our products, as well as their dispersion across different geographic areas.
We monitor the financial
performance and creditworthiness of our customers so that we can properly assess and respond to changes in their credit profile.
We continue to monitor these conditions and assess their possible impact on our business.
|
Inventories |
Inventories
Inventories are recorded
at the lower of cost or net realizable value, with cost determined by the weighted average cost method. The Company periodically
reviews the composition of inventory in order to identify excess, obsolete, slow-moving or otherwise non-saleable items taking
into account anticipated future sales compared with quantities on hand, and the remaining shelf life of goods on hand. If non-saleable
items are observed and there are no alternate uses for the inventory, the Company records a write-down to net realizable value
in the period that the decline in value is first recognized. Although the Company makes every effort to ensure the accuracy of
forecasts of future product demand, any significant unanticipated decreases in demand could have a material impact on the carrying
value of inventories and reported operating results. The Company’s reserves were approximately $21,000 as of September 30,
2023. The Company did not have inventory on hand prior to the acquisition of Zembrace and Tosymra on June 30, 2023.
|
Property and equipment |
Property and equipment
Property and equipment
are stated at cost, less accumulated depreciation. Depreciation is calculated using the straight-line method over the asset’s
estimated useful life, which ranges from 20 to 40 years for buildings, 15 years for land improvements and laboratory equipment,
three years for computer assets, five years for furniture and all other equipment and the shorter of the useful life or term of
lease for leasehold improvements. Depreciation on assets begins when the asset is placed in service. Depreciation and amortization
expense for the three and nine months ended September 30, 2023, was $978,000 and $2.8 million, respectively, and $252,000
and $417,000, respectively, for the three and nine months ended September 30, 2022. All property and equipment are located in the
United States.
|
Intangible assets, net |
Intangible assets, net
Intangible assets deemed
to have finite lives are carried at acquisition-date fair value less accumulated amortization and impairment, if any. Finite-lived
intangible assets consist of developed technology intangible assets acquired in connection with the acquisition of certain products
from Upsher Smith Laboratories, LLS (“USL Acquisition”) consummated on June 30, 2023 (See Note 8). The acquired intangible
assets are amortized using the straight-line method over the estimated useful lives of the respective assets. Amortization expense
for the three months ended September 30, 2023, was $238,000. The annual impairment assessment date will be June 30. No triggering events were identified during the nine months ended September 30, 2023.
During the year ended
December 31, 2015, the Company purchased certain internet domain rights, which were determined to have an indefinite life. Identifiable
intangibles with indefinite lives, which are included in Intangible assets, net on the condensed consolidated balance sheet, are
not amortized but are tested for impairment annually or whenever events or changes in circumstances indicate that their carrying
amount may be less than fair value. As of September 30, 2023, the Company believed that no impairment existed.
|
Goodwill |
Goodwill
Goodwill represents
the excess of the aggregate purchase price over the fair value of the net tangible and intangible assets acquired in a business
combination. Goodwill is reviewed for impairment on an annual basis, or more frequently if events or changes in circumstances indicate
that the carrying amount of goodwill may be impaired. As of September 30, 2023, the Company has recognized goodwill in connection with
the USL Acquisition consummated on June 30, 2023 (See Note 8).
|
Leases |
Leases
The Company determines
if an arrangement is, or contains, a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”)
assets, operating lease liabilities, current and operating lease liabilities, noncurrent in the Company’s condensed consolidated
balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities
represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized
at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide
an implicit rate, the Company uses an incremental borrowing rate based on the information available at the transition date and
subsequent lease commencement dates in determining the present value of lease payments. This is the rate the Company would have
to pay if borrowing on a collateralized basis over a similar term to each lease. The operating lease ROU asset excludes lease incentives.
The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company
will exercise that option. Lease expense for lease payments made under operating leases is recognized on a straight-line basis
over the lease term.
|
Convertible Preferred Stock |
Convertible Preferred Stock
Preferred shares subject
to mandatory redemption are classified as liability instruments and are measured at fair value. The Company classifies conditionally
redeemable preferred shares, which includes preferred shares that feature redemption rights that are either within the control
of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control, as
temporary equity (“mezzanine”) until such time as the conditions are removed or lapse.
|
Revenue Recognition |
Revenue Recognition
The
Company records and recognizes revenue in a manner that depicts the transfer of promised goods or services to customers in an
amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services.
The Company’s revenues primarily result from contracts with customers, which are generally short-term and have a single
performance obligation - the delivery of product. The Company’s performance obligation to deliver products is satisfied
at the point in time that the goods are received by the customer, which is when the customer obtains title to and has the
risks and rewards of ownership of the products, which is generally upon shipment or delivery to the customer as stipulated by
the terms of the sale agreements. The transaction price is the amount of consideration to
which the Company expects to be entitled in exchange for transferring promised goods to a customer. The consideration promised
in a contract with a customer may include fixed amounts, variable amounts, or both. Our contractual payment terms are typically 30 to 90 days.
Revenues from product
sales, net of gross-to-net deductions, are recorded only to the extent a significant reversal in the amount of cumulative revenue
recognized is not probable of occurring and when the uncertainty associated with gross-to-net deductions is subsequently resolved.
Taxes assessed by governmental authorities and collected from customers are excluded from product sales. Shipping and handling
activities are considered to be fulfillment activities and not a separate performance obligation.
Many of the Company’s
products sold are subject to a variety of deductions. Revenues are recognized net of estimated rebates and chargebacks, cash discounts,
distributor fees, sales return provisions and other related deductions. Deductions to product sales are referred to as gross-to-net
deductions and are estimated and recorded in the period in which the related product sales occur. Accruals for these provisions
are presented in the consolidated financial statements as reductions to gross sales in determining net sales, and as a contra asset
within accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash). Amounts recorded for revenue
deductions can result from a complex series of judgements about future events and uncertainties and can rely heavily on estimates
and assumptions. The following section briefly describes the nature of the Company’s provisions for variable consideration
and how such provisions are estimated:
Chargebacks -
The Company sells a portion of its products indirectly through wholesaler distributors, and enters into specific agreements with
these indirect customers to establish pricing for the Company’s products, and in-turn, the indirect customers and entities
independently purchase these products. Because the price paid by the indirect customers and/or entities is lower than the price
paid by the wholesaler, the Company provides a credit, called a chargeback, to the wholesaler for the difference between the contractual
price with the indirect customers and the wholesale customer’s purchase price. The Company’s provision for chargebacks
is based on expected sell-through levels by the Company’s wholesale customers to the indirect customers and estimated wholesaler
inventory levels as well as historical chargeback rates. The Company continually monitors its reserve for chargebacks and adjusts
the reserve accordingly when expected chargebacks differ from actual experience.
Rebates - The
Company participates in certain government and specific sales rebate programs which provides discounted prescription drugs to qualified
recipients, and primarily relate to Medicaid and managed care rebates in the U.S., pharmacy rebates, Tri-Care rebates and discounts,
specialty pharmacy program fees and other governmental rebates or applicable allowances.
| ● | Managed Care Rebates are processed in the quarter following the quarter in which they are earned.
The managed care reporting entity submits utilization data after the end of the quarter and the Company processes the payment in
accordance with contract terms. All rebates earned but not paid are estimated by the Company according to historical payments trended
for market growth assumptions. |
| ● | Medicaid and State Agency rebates are based upon historical experience of claims submitted by various
states. The Company monitors Medicaid legislative changes to determine what impact such legislation may have on the provision for
Medicaid rebates. The accrual of State Agency reserves is based on historical payment rates. There is an approximate three-month
lag from the time of product sale until the rebate is paid. |
| ● | Tri-Care represents a regionally managed health care program for active duty and retired members,
dependents and survivors of the US military. The Tri-Care program supplements health care resources of the US military with civilian
health care professionals for greater access and quality healthcare coverage. Through the Tri-Care program, the Company provides
pharmaceuticals on a direct customer basis. Prices of pharmaceuticals sold under the Tri-Care program are pre-negotiated and a
reserve amount is established to represent the proportionate rebate amount associated with product sales. |
| ● | Coverage Gap refers to the Medicare prescription drug program and represents specifically the period
between the initial Medicare Part D prescription drug program coverage limit and the catastrophic coverage threshold. Applicable
pharmaceutical products sold during this coverage gap timeframe are discounted by the Company. Since the nature of the program
is that coverage limits are reset at the beginning of the calendar year; the payments escalate each quarter as the participants
reach the coverage limit before reaching the catastrophic coverage threshold. The Company has determined that the cost of this
reserve will be viewed as an annual cost. Therefore, the accrual will be incurred evenly during the year with quarterly review
of the liability based on payment trends and any revision to the projected annual cost. |
Prompt-Pay and other
Sales Discounts - The Company provides for prompt pay discounts, which early payments are recorded as a reduction of revenue
and as a reduction in the accounts receivable at the time of sale based on the customer’s contracted discount rate. Consumer
sales discounts represent programs the Company has in place to reduce costs to the patient. This includes copay buy down and eVoucher
programs.
Product Returns
- Consistent with industry practice, the Company offers customers a right to return any unused product. The customer’s right
of return commences typically six months prior to product expiration date and ends one year after product expiration date. Products returned
for expiration are reimbursed at current wholesale acquisition cost or indirect contract price. The Company estimates the amount
of its product sales that may be returned by the Company’s customers and accrues this estimate as a reduction of revenue
in the period the related product revenue is recognized. The Company estimates products returns as a percentage of sales to its
customers. The rate is estimated by using historical sales information, including its visibility and estimates into the inventory
remaining in the distribution channel. Adjustments are made to the current provision for returns when data suggests product returns
may differ from original estimates.
|
Research and Development Costs |
Research and Development Costs
The Company outsources
certain of its research and development efforts and expenses these costs as incurred, including the cost of manufacturing products
for testing, as well as licensing fees and costs associated with planning and conducting clinical trials. The value ascribed to
patents and other intellectual property acquired has been expensed as research and development costs, as such property is related
to particular research and development projects and had no alternative future uses.
The Company estimates
its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under
clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations,
which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services
are provided under such contracts. The Company accounts for trial expenses according to the timing of various aspects of the trial.
The Company determines accrual estimates taking into account discussion with applicable personnel and outside service providers
as to the progress or state of consummation of trials, or the services completed.
During the course of
a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company
makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that
time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations
and other third-party vendors.
|
Government Grants |
Government Grants
From time to time, the
Company may enter into arrangements with governmental entities for the purpose of obtaining funding for research and development
activities. The Company is reimbursed for costs incurred that are associated with specified research and development activities
included in the grant application approved by the government authority. The Company classifies government grants received under
these arrangements as a reduction to the related research and development expense in the same period as the relevant expenses are
incurred. In August 2022, the Company announced that it received a Cooperative Agreement grant from the National Institute on Drug
Abuse (“NIDA”), part of the National Institutes of Health, to support the development of its TNX-1300 product candidate
for the treatment of cocaine intoxication. During the three and nine months ended September 30, 2023, we received $0.4 and $2.3
million, respectively, for the three and nine months ended September 30, 2023, in funding as a reduction of related research and
development expense.
|
Stock-based compensation |
Stock-based compensation
All stock-based payments
to employees and to nonemployees for their services, including grants of restricted stock units (“RSUs”), and stock
options, are measured at fair value on the grant date and recognized in the condensed consolidated statements of operations as
compensation or other expense over the requisite service period. The Company accounts for share-based awards in accordance with
the provisions of the Accounting Standards Codification (“ASC”) 718, Compensation – Stock Compensation.
|
Foreign Currency Translation |
Foreign Currency Translation
Operations of the Company’s
Canadian subsidiary, Tonix Pharmaceuticals (Canada), Inc., are conducted in local currency, which represents its functional currency.
The U.S. dollar is the functional currency of the other foreign subsidiaries. Balance sheet accounts of the Canadian subsidiary
were translated from foreign currency into U.S. dollars at the exchange rate in effect at the balance sheet date and income statement
accounts were translated at the average rate of exchange prevailing during the period. Translation adjustments resulting from this
process were included in accumulated other comprehensive loss on the consolidated condensed balance sheets.
|
Comprehensive Income (Loss) |
Comprehensive Income (Loss)
Comprehensive income
(loss) is defined as the change in equity of a business during a period from transactions and other events and circumstances from
non-owners sources. It includes all changes in equity during a period except those resulting from investments by owners and distributions
to owners. Other comprehensive income (loss) represents foreign currency translation adjustments.
|
Income Taxes |
Income Taxes
Deferred income tax
assets and liabilities are determined based on the estimated future tax effects of net operating loss and credit carryforwards
and temporary differences between the tax basis of assets and liabilities and their respective financial reporting amounts measured
at the current enacted tax rates. The Company records a valuation allowance on its deferred income tax assets if it is not more
likely than not that these deferred income tax assets will be realized.
The Company recognizes
a tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination
by taxing authorities, based on the technical merits of the position. The tax benefits recognized in the condensed consolidated
financial statements from such a position are measured based on the largest benefit that has a greater than 50% likelihood of being
realized upon ultimate settlement. As of September 30, 2023, the Company has not recorded any unrecognized tax benefits. The Company’s
policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.
|
Per Share Data |
Per Share Data
The computation of basic
and diluted loss per share for the quarters ended September 30, 2023 and 2022 excludes potentially dilutive securities when their
inclusion would be anti-dilutive, or if their exercise prices were greater than the average market price of the common stock during
the period.
All warrants and preferred
stock issued participate on a one-for-one basis with common stock in the distribution of dividends, if and when declared by the
Board of Directors, on the Company’s common stock. For purposes of computing EPS, these warrants and preferred stock are
considered to participate with common stock in earnings of the Company. Therefore, the Company calculates basic and diluted EPS
using the two-class method. Under the two-class method, net income for the period is allocated between common stockholders and
participating securities according to dividends declared and participation rights in undistributed earnings. No income was allocated
to the warrants and preferred stock for the three and nine months ended September 30, 2023, and 2022, as results of operations
were a loss for the periods.
Potentially dilutive
securities excluded from the computation of basic and diluted net loss per share, as of September 30, 2023 and 2022, are as follows:
|
|
2023 |
|
|
2022 |
|
Warrants to purchase common stock |
|
|
7,003,196 |
|
|
|
3,196 |
|
Options to purchase common stock |
|
|
1,384,264 |
|
|
|
392,643 |
|
Totals |
|
|
8,387,460 |
|
|
|
395,839 |
|
|
Recently Adopted Accounting Pronouncements |
Recently Adopted Accounting Pronouncements
In August 2020, the
FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts
in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity,
which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU
also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative scope exception,
and it also simplifies the diluted earnings per share calculation in certain areas. The Company adopted ASU 2020-06 on January
1, 2023, under the modified retrospective method of transition. The adoption of ASU 2020-06 did not impact the Company’s
financial position, results of operations or cash flows.
In June 2016, the FASB
issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments. The main objective of ASU 2016-13 is to provide financial
statement users with more decision-useful information about an entity’s expected credit losses on financial instruments and
other commitments to extend credit at each reporting date. To achieve this objective, the amendments in this update replace the
incurred loss impairment methodology currently used today with a methodology that reflects expected credit losses and requires
consideration of a broader range of reasonable and supportable information to develop credit loss estimates. ASU 2016-13 will be
effective for the Company for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years,
using a modified retrospective approach. Early adoption is permitted. The Company adopted ASU 2016-13 and related updates as of
January 1, 2023. The adoption of ASU 2016-13 did not impact the Company’s financial position, results of operations or cash
flows.
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v3.23.3
SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statement of cash flows: |
The following table
provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets
that sum to the total of the same amounts shown in the condensed consolidated statement of cash flows:
|
|
September 30,
2023 |
|
|
September 30,
2022 |
|
|
|
(in thousands) |
|
Cash and cash equivalents |
|
$ |
6,914 |
|
|
$ |
139,978 |
|
Restricted cash |
|
|
1,002 |
|
|
|
240 |
|
Total |
|
$ |
7,916 |
|
|
$ |
140,218 |
|
|
Potentially dilutive securities excluded from the computation of basic and diluted net loss per share, as of September 30, 2023 and 2022, are as follows: |
Potentially dilutive
securities excluded from the computation of basic and diluted net loss per share, as of September 30, 2023 and 2022, are as follows:
|
|
2023 |
|
|
2022 |
|
Warrants to purchase common stock |
|
|
7,003,196 |
|
|
|
3,196 |
|
Options to purchase common stock |
|
|
1,384,264 |
|
|
|
392,643 |
|
Totals |
|
|
8,387,460 |
|
|
|
395,839 |
|
|
X |
- References
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v3.23.3
INVENTORY (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Inventory Disclosure [Abstract] |
|
The components of inventory consisted of the following as of September 30, 2023: |
The components of inventory
consisted of the following as of September 30, 2023:
|
|
September
30,
2023 |
|
|
December
31,
2022 |
|
|
|
(in
thousands) |
|
Raw Materials |
|
$ |
3,064 |
|
|
$ |
— |
|
Work-in-process |
|
|
1,565 |
|
|
|
— |
|
Finished Goods |
|
|
8,709 |
|
|
|
— |
|
|
|
|
13,338 |
|
|
$ |
— |
|
Less: Inventory reserves |
|
|
(21 |
) |
|
|
— |
|
Total Inventory |
|
$ |
13,317 |
|
|
$ |
— |
|
|
X |
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v3.23.3
PROPERTY AND EQUIPMENT, NET (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Property and equipment, net consisted of the following (in thousands): |
Property and equipment,
net consisted of the following (in thousands):
|
|
September 30,
2023 |
|
|
December 31,
2022 |
|
|
|
(in thousands) |
|
Property and equipment, net: |
|
|
|
|
|
|
|
|
Land |
|
$ |
8,011 |
|
|
$ |
8,011 |
|
Land improvements |
|
|
326 |
|
|
|
79 |
|
Buildings |
|
|
65,825 |
|
|
|
65,644 |
|
Office furniture and equipment |
|
|
2,355 |
|
|
|
1,893 |
|
Laboratory equipment |
|
|
21,506 |
|
|
|
18,440 |
|
Leasehold improvements |
|
|
34 |
|
|
|
34 |
|
Construction in progress |
|
|
1,204 |
|
|
|
1,366 |
|
|
|
|
99,261 |
|
|
|
95,467 |
|
Less: Accumulated depreciation and amortization |
|
|
(4,395 |
) |
|
|
(1,653 |
) |
|
|
$ |
94,866 |
|
|
$ |
93,814 |
|
|
X |
- References
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v3.23.3
GOODWILL AND INTANGIBLE ASSETS (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
The following table provides the gross carrying value of goodwill as follows: |
The following table
provides the gross carrying value of goodwill as follows:
|
|
Amounts |
|
|
|
(in thousands) |
Balance at December 31, 2022 |
|
$ |
— |
|
Acquired during the period (see Note 8) |
|
|
965 |
|
Balance at September 30, 2023 |
|
$ |
965 |
|
|
The following table provides the gross carrying amount and accumulated amortization for each major class of intangible asset: |
The following table
provides the gross carrying amount and accumulated amortization for each major class of intangible asset:
|
|
September 30,
2023 |
|
|
December 31,
2022 |
|
|
|
(in thousands) |
|
Intangible assets subject to amortization |
|
|
|
|
|
|
|
|
Developed technology |
|
$ |
10,100 |
|
|
$ |
— |
|
Less: Accumulated amortization |
|
|
238 |
|
|
|
— |
|
Total |
|
$ |
9,862 |
|
|
$ |
— |
|
Intangible assets not subject to amortization |
|
|
|
|
|
|
|
|
Internet domain rights |
|
$ |
120 |
|
|
$ |
120 |
|
Total intangible assets, net |
|
$ |
9,982 |
|
|
$ |
120 |
|
|
At September 30, 2023, the related amortization for each of the next five years ended December 31 is as follows (in thousands): |
At September 30, 2023,
the related amortization for each of the next five years ended December 31 is as follows (in thousands):
Year Ending December 31, |
|
|
|
|
Remainder of 2023 |
|
|
$ |
238 |
|
2024 |
|
|
|
953 |
|
2025 |
|
|
|
953 |
|
2026 |
|
|
|
953 |
|
2027 and beyond |
|
|
|
6,765 |
|
|
|
|
$ |
9,862 |
|
|
X |
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v3.23.3
TEMPORARY EQUITY (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Temporary Equity |
|
The Series A Preferred Stock and Series B Preferred Stock was recorded at redemption value |
Since the Preferred
Stock had a redemption feature at the option of the holder, it was classified as temporary equity. The Series A Preferred Stock
and Series B Preferred Stock was recorded at redemption value of approximately $14.7 million and $1.1 million, respectively, as
calculated in the following table (in thousands):
|
|
Series A Preferred Stock |
|
|
Series B Preferred Stock |
|
Gross Proceeds |
|
$ |
13,300 |
|
|
$ |
950 |
|
Less: |
|
|
|
|
|
|
|
|
Preferred stock issuance costs |
|
|
(844 |
) |
|
|
(60 |
) |
Plus: |
|
|
|
|
|
|
|
|
Accretion of carrying value to redemption value |
|
|
2,244 |
|
|
|
160 |
|
Preferred stock subject to possible redemption |
|
$ |
14,700 |
|
|
$ |
1,050 |
|
Since the Preferred
Stock had a redemption feature at the option of the holder, it was classified as temporary equity. The Series A Preferred Stock
and Series B Preferred Stock was recorded at redemption value of approximately $26.3 million and $5.2 million, respectively, as
calculated in the following table (in thousands):
|
|
Series A Preferred Stock |
|
|
Series B Preferred Stock |
|
Gross Proceeds |
|
$ |
23,750 |
|
|
$ |
4,750 |
|
Less: |
|
|
|
|
|
|
|
|
Preferred stock issuance costs |
|
|
(1,046 |
) |
|
|
(209 |
) |
Plus: |
|
|
|
|
|
|
|
|
Accretion of carrying value to redemption value |
|
|
3,546 |
|
|
|
709 |
|
Preferred stock subject to possible redemption |
|
$ |
26,250 |
|
|
$ |
5,250 |
|
|
X |
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X |
- DefinitionTabular disclosure of disaggregation of revenue into categories depicting how nature, amount, timing, and uncertainty of revenue and cash flows are affected by economic factor.
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v3.23.3
ASSET PURCHASE AGREEMENT WITH UPSHER-SMITH (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Business Combination and Asset Acquisition [Abstract] |
|
The following table summarizes the components of the purchase consideration (in thousands): |
As
consideration for acquisition of the Business and certain product-related inventories, the Company paid approximately $23.5
million in cash upfront. On the earlier of March
2024 and the completion of the transition services to be provided by USL, as described above, the Company agreed to pay an additional
deferred payment of $3.0
million in cash, which is included in Accrued expenses and other current liabilities on
the accompanying balance sheet. The following table summarizes the components of the purchase consideration (in thousands):
Preliminary purchase consideration |
|
Amount |
|
Closing cash consideration |
|
$ |
22,174 |
|
Inventory adjustment payment liability |
|
|
1,348 |
|
Deferred payment liability |
|
|
3,000 |
|
Purchase price to be allocated |
|
$ |
26,522 |
|
|
The following table represents the preliminary allocation of the purchase price to the assets acquired by the Company in the USL Acquisition recognized in the Company’s consolidated balance sheets (in thousands): |
The following table
represents the preliminary allocation of the purchase price to the assets acquired by the Company in the USL Acquisition recognized
in the Company’s consolidated balance sheets (in thousands):
Preliminary purchase price allocation |
|
Amount |
|
Inventory |
|
$ |
13,700 |
|
Prepaid expenses and other |
|
|
1,757 |
|
Intangible assets, net |
|
|
10,100 |
|
Goodwill |
|
|
965 |
|
Fair value of assets acquired |
|
$ |
26,522 |
|
|
The identifiable intangible assets acquired and their estimated useful lives for amortization are as follows (in thousands): |
Intangible assets eligible
for recognition separate from goodwill were those that satisfied either the contractual or legal criterion or the separability
criterion in the accounting guidance. The identifiable intangible assets acquired and their estimated useful lives for amortization
are as follows (in thousands):
|
|
Fair Value |
|
|
Useful Life
(years) |
|
Developed technology - Tosymra |
|
$ |
3,400 |
|
|
|
9 |
|
Developed technology - Zembrace |
|
|
6,700 |
|
|
|
14 |
|
Total |
|
$ |
10,100 |
|
|
|
|
|
|
The following unaudited pro forma consolidated financial information reflects the results of operations of the Company for the three and nine months ended September 30, 2023 and 2022 as if the USL Acquisition had occurred as of January 1, 2022 and gives effect to transactions that are directly attributable to the acquisition. |
The following unaudited
pro forma consolidated financial information reflects the results of operations of the Company for the three and nine months ended
September 30, 2023 and 2022 as if the USL Acquisition had occurred as of January 1, 2022 and gives effect to transactions that
are directly attributable to the acquisition. These amounts are based on financial information of the acquired business and are
not necessarily indicative of what the Company’s operating results would have been had the acquisition taken place on the
date presented, nor is it indicative of the Company’s future operating results.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Net Product Sales |
|
$ |
3,989 |
|
|
$ |
3,635 |
|
|
$ |
11,610 |
|
|
$ |
7,612 |
|
Net Loss |
|
$ |
(27,072 |
) |
|
$ |
(33,698 |
) |
|
$ |
(91,252 |
) |
|
$ |
(95,073 |
) |
|
X |
- DefinitionTabular disclosure of asset acquisition.
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v3.23.3
STOCK-BASED COMPENSATION (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
A summary of the stock option activity and related information for the Plans for the nine months ended September 30, 2023 is as follows: |
A summary of the stock
option activity and related information for the Plans for the nine months ended September 30, 2023 is as follows:
|
|
Shares |
|
|
Weighted-
Average Exercise Price |
|
|
Weighted-
Average Remaining Contractual
Term |
|
|
Aggregate
Intrinsic
Value |
|
Outstanding at December 31, 2022 |
|
|
392,643 |
|
|
$ |
334.08 |
|
|
|
8.70 |
|
|
$ |
— |
|
Grants |
|
|
1,019,130 |
|
|
|
4.64 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
Forfeitures or expirations |
|
|
(27,509 |
) |
|
|
453.81 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2023 |
|
|
1,384,264 |
|
|
$ |
89.09 |
|
|
|
9.01 |
|
|
$ |
— |
|
Exercisable at September 30, 2023 |
|
|
248,656 |
|
|
$ |
392.48 |
|
|
|
7.78 |
|
|
$ |
|
|
|
The assumptions used in the valuation of stock options granted during the nine months ended September 30, 2023 and 2022 were as follows: |
The assumptions used
in the valuation of stock options granted during the nine months ended September 30, 2023 and 2022 were as follows:
|
|
Nine Months Ended
September 30, 2023 |
|
|
Nine Months Ended
September 30, 2022 |
|
Risk-free interest rate |
|
|
3.42% to 4.35 |
% |
|
|
1.67% to 3.05 |
% |
Expected term of option |
|
|
5.0 to 10 years |
|
|
|
5.5 to 10 years |
|
Expected stock price volatility |
|
|
122.19% - 142.72 |
% |
|
|
120.32% - 133.22 |
% |
Expected dividend yield |
|
|
0.0 |
|
|
|
0.0 |
|
|
X |
- DefinitionTabular disclosure for stock option plans. Includes, but is not limited to, outstanding awards at beginning and end of year, grants, exercises, forfeitures, and weighted-average grant date fair value.
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v3.23.3
LEASES (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Leases |
|
At September 30, 2023, future minimum lease payments for operating leases with non-cancelable terms of more than one year were as follows (in thousands): |
At September 30, 2023,
future minimum lease payments for operating leases with non-cancelable terms of more than one year were as follows (in thousands):
Year Ending December 31, |
|
|
|
|
|
2023 |
|
|
$ |
107 |
|
2024 |
|
|
|
460 |
|
2025 |
|
|
|
299 |
|
2026 |
|
|
|
142 |
|
2027 and beyond |
|
|
|
246 |
|
|
|
|
|
1,254 |
|
Included interest |
|
|
|
(104 |
) |
|
|
|
$ |
1,150 |
|
|
Other information related to leases is as follows: |
Other information related to leases is as follows:
Cash paid for amounts included in the measurement of lease liabilities: |
|
Nine
Months Ended
September 30, 2023 |
|
|
Nine
Months Ended
September 30, 2022 |
|
Operating cash flow from operating leases (in thousands) |
|
$ |
434 |
|
|
$ |
447 |
|
|
|
|
|
|
|
|
|
|
Weighted Average Remaining Lease Term |
|
|
|
|
|
|
|
|
Operating leases |
|
|
3.50 years |
|
|
|
2.33 years |
|
|
|
|
|
|
|
|
|
|
Weighted Average Discount Rate |
|
|
|
|
|
|
|
|
Operating leases |
|
|
4.63 |
% |
|
|
2.26 |
% |
|
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v3.23.3
BUSINESS (Details Narrative) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Sep. 30, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
|
Working capital |
$ 13,600
|
|
|
Accumulated deficit |
(573,336)
|
$ (470,038)
|
|
Cash and cash equivalents |
$ 6,914
|
$ 120,229
|
$ 139,978
|
X |
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v3.23.3
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same amounts shown in the condensed consolidated statement of cash flows: (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Sep. 30, 2022 |
Dec. 31, 2021 |
Accounting Policies [Abstract] |
|
|
|
|
Cash and cash equivalents |
$ 6,914
|
$ 120,229
|
$ 139,978
|
|
Restricted cash |
1,002
|
|
240
|
|
Total |
$ 7,916
|
$ 120,470
|
$ 140,218
|
$ 178,900
|
X |
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v3.23.3
Potentially dilutive securities excluded from the computation of basic and diluted net loss per share, as of September 30, 2023 and 2022, are as follows: (Details) - shares
|
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Totals |
8,387,460
|
395,839
|
Warrant [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Totals |
7,003,196
|
3,196
|
Share-Based Payment Arrangement, Option [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Totals |
1,384,264
|
392,643
|
X |
- DefinitionSecurities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) or earnings per unit (EPU) in the future that were not included in the computation of diluted EPS or EPU because to do so would increase EPS or EPU amounts or decrease loss per share or unit amounts for the period presented.
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v3.23.3
SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) $ in Thousands |
|
|
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2023
USD ($)
|
May 09, 2023 |
Sep. 30, 2023
USD ($)
|
Sep. 30, 2022
USD ($)
|
Sep. 30, 2023
USD ($)
Segment
|
Sep. 30, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Number of Operating Segments | Segment |
|
|
|
|
1
|
|
|
Money market funds |
$ 3,700
|
|
$ 3,700
|
|
$ 3,700
|
|
$ 116,300
|
Restricted cash |
244
|
|
244
|
|
244
|
|
241
|
Restricted cash held by vendors in escrow accounts |
758
|
|
758
|
|
758
|
|
|
Inventory reserves |
$ 21
|
|
21
|
|
21
|
|
|
Depreciation and amortization expense |
|
|
978
|
$ 252
|
$ 2,800
|
$ 417
|
|
Amortization of Intangible Assets |
|
|
238
|
|
|
|
|
Contractual payment terms |
|
|
|
|
30 to 90 days
|
|
|
Government grants |
|
|
$ 400
|
|
$ 2,300
|
|
|
Land Improvements and Lab Equipment [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Estimated useful life of property and equipment |
15 years
|
|
15 years
|
|
15 years
|
|
|
Computer Equipment [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Estimated useful life of property and equipment |
3 years
|
|
3 years
|
|
3 years
|
|
|
Furniture and All Other Equipment [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Estimated useful life of property and equipment |
5 years
|
|
5 years
|
|
5 years
|
|
|
Leasehold Improvements [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Property, Plant, and Equipment, Useful Life, Term, Description [Extensible Enumeration] |
Useful Life, Shorter of Lease Term or Asset Utility [Member]
|
|
Useful Life, Shorter of Lease Term or Asset Utility [Member]
|
|
Useful Life, Shorter of Lease Term or Asset Utility [Member]
|
|
|
Minimum [Member] | Building [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Estimated useful life of property and equipment |
20 years
|
|
20 years
|
|
20 years
|
|
|
Maximum [Member] | Building [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Estimated useful life of property and equipment |
40 years
|
|
40 years
|
|
40 years
|
|
|
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Customer 1 [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Concentration Risk, Percentage |
|
|
25.00%
|
|
25.00%
|
|
|
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Customer 2 [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Concentration Risk, Percentage |
|
|
21.00%
|
|
21.00%
|
|
|
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Customer 3 [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Concentration Risk, Percentage |
|
|
18.00%
|
|
18.00%
|
|
|
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Customer 4 [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Concentration Risk, Percentage |
|
|
14.00%
|
|
14.00%
|
|
|
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer 1 [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Concentration Risk, Percentage |
25.00%
|
|
|
|
|
|
|
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer 2 [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Concentration Risk, Percentage |
23.00%
|
|
|
|
|
|
|
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer 3 [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Concentration Risk, Percentage |
19.00%
|
|
|
|
|
|
|
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer 4 [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Concentration Risk, Percentage |
15.00%
|
|
|
|
|
|
|
Product 1 [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] | Minimum [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Concentration Risk, Percentage |
|
|
10.00%
|
|
10.00%
|
|
|
Product 2 [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] | Minimum [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Concentration Risk, Percentage |
|
|
10.00%
|
|
10.00%
|
|
|
Products 1 and 2 [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Concentration Risk, Percentage |
|
|
100.00%
|
|
100.00%
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Reverse stock split |
|
1-for-6.25
|
|
|
|
|
|
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Property and equipment, net consisted of the following (in thousands): (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment gross |
$ 99,261
|
$ 95,467
|
Less: Accumulated depreciation and amortization |
(4,395)
|
(1,653)
|
Property and equipment, net |
94,866
|
93,814
|
Land [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment gross |
8,011
|
8,011
|
Land Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment gross |
326
|
79
|
Building [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment gross |
65,825
|
65,644
|
Office Furniture And Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment gross |
2,355
|
1,893
|
Laboratory Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment gross |
21,506
|
18,440
|
Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment gross |
34
|
34
|
Construction in Progress [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment gross |
$ 1,204
|
$ 1,366
|
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v3.23.3
PROPERTY AND EQUIPMENT, NET (Details Narrative)
|
|
|
|
3 Months Ended |
9 Months Ended |
12 Months Ended |
27 Months Ended |
Oct. 01, 2021
USD ($)
ft²
|
Dec. 23, 2020
USD ($)
a
|
Sep. 28, 2020
USD ($)
ft²
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
|
Property and equipment |
|
|
|
$ 94,866,000
|
$ 94,866,000
|
|
$ 93,814,000
|
$ 93,814,000
|
Proceeds from sale of property and equipment |
|
|
|
|
992,000
|
|
|
|
Sold Property and Equipment [Member] |
|
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
|
Property and equipment |
|
|
|
800,000
|
$ 800,000
|
|
|
|
Proceeds from sale of property and equipment |
|
|
|
$ 1,000,000
|
|
|
|
|
MARYLAND |
|
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
|
Area of facility | ft² |
45,000
|
|
|
|
|
|
|
|
Facility purchase |
$ 17,500,000
|
|
|
|
|
|
|
|
MARYLAND | Land [Member] |
|
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
|
Facility purchase |
2,100,000
|
|
|
|
|
|
|
|
MARYLAND | Building [Member] |
|
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
|
Facility purchase |
13,900,000
|
|
|
|
|
|
|
|
MARYLAND | Office Furniture and Equipment and Laboratory Equipment [Member] |
|
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
|
Facility purchase |
$ 1,500,000
|
|
|
|
|
|
|
|
MASSACHUSETTS |
|
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
|
Area of facility | ft² |
|
|
45,000
|
|
|
|
|
|
Facility purchase |
|
|
$ 4,000,000
|
|
|
|
|
|
Costs incurred |
|
|
|
|
|
|
$ 38,800,000
|
|
Total costs incurred |
|
|
|
|
|
|
|
$ 61,600,000
|
MASSACHUSETTS | Land [Member] |
|
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
|
Facility purchase |
|
|
1,200,000
|
|
|
|
|
|
MASSACHUSETTS | Building [Member] |
|
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
|
Facility purchase |
|
|
$ 2,800,000
|
|
|
|
|
|
MONTANA |
|
|
|
|
|
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
|
|
|
Area of facility | a |
|
44
|
|
|
|
|
|
|
Facility purchase |
|
$ 4,500,000
|
|
|
|
|
|
|
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v3.23.3
STOCKHOLDERS’ EQUITY (Details Narrative) - $ / shares
|
Oct. 17, 2023 |
May 09, 2023 |
Sep. 30, 2023 |
May 07, 2023 |
Dec. 31, 2022 |
Dec. 13, 2022 |
Dec. 11, 2022 |
Aug. 05, 2022 |
Aug. 03, 2022 |
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
Common stock shares authorized |
|
160,000,000
|
160,000,000
|
1,000,000,000
|
160,000,000
|
160,000,000
|
24,000,000
|
24,000,000
|
8,000,000
|
Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
Period of business days of non-compliance with minimum bid requirement |
30 days
|
|
|
|
|
|
|
|
|
Nasdaq minimum bid requirement |
$ 1
|
|
|
|
|
|
|
|
|
Period to regain compiance with minimum bid requirement |
180 days
|
|
|
|
|
|
|
|
|
Additional period to regain compiance with minimum bid requirement |
180 days
|
|
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
Stockholders equity, reverse stock split |
|
1-for-6.25
|
|
|
|
|
|
|
|
Conversion of stock, shares converted |
|
64,627,246
|
|
|
|
|
|
|
|
Common stock exchanged |
|
10,340,506
|
|
|
|
|
|
|
|
Additional shares issue |
|
131,902
|
|
|
|
|
|
|
|
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- DefinitionAdditional period of calendar days to regain compiance with minimum bid requirement.
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v3.23.3
The Series A Preferred Stock and Series B Preferred Stock was recorded at redemption value (Details) - USD ($) $ in Thousands |
Oct. 26, 2022 |
Jun. 24, 2022 |
Series A Preferred Stock [Member] |
|
|
Gross Proceeds |
$ 13,300
|
$ 23,750
|
Preferred stock issuance costs |
(844)
|
(1,046)
|
Accretion of carrying value to redemption value |
2,244
|
3,546
|
Preferred stock subject to possible redemption |
14,700
|
26,250
|
Series B Preferred Stock [Member] |
|
|
Gross Proceeds |
950
|
4,750
|
Preferred stock issuance costs |
(60)
|
(209)
|
Accretion of carrying value to redemption value |
160
|
709
|
Preferred stock subject to possible redemption |
$ 1,050
|
$ 5,250
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v3.23.3
TEMPORARY EQUITY (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
|
|
|
|
1 Months Ended |
9 Months Ended |
|
|
|
|
Dec. 13, 2022 |
Oct. 26, 2022 |
Aug. 05, 2022 |
Jun. 24, 2022 |
Dec. 31, 2022 |
Aug. 31, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
May 09, 2023 |
May 07, 2023 |
Dec. 11, 2022 |
Aug. 03, 2022 |
Common stock, authorized |
160,000,000
|
|
24,000,000
|
|
160,000,000
|
|
160,000,000
|
|
160,000,000
|
1,000,000,000
|
24,000,000
|
8,000,000
|
Escrow deposit |
|
|
|
|
|
|
$ 758
|
|
|
|
|
|
Redemption amount |
|
|
|
|
|
|
|
$ 31,500
|
|
|
|
|
Series A Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
1,400,000
|
|
2,500,000
|
|
|
|
|
|
|
|
|
Preferred stock, par value (in dollars per share) |
|
$ 0.001
|
|
$ 0.001
|
|
|
|
|
|
|
|
|
Preferred stock subject to possible redemption |
|
$ 14,700
|
|
$ 26,250
|
|
|
|
|
|
|
|
|
Series B Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
100,000
|
|
500,000
|
|
|
|
|
|
|
|
|
Preferred stock, par value (in dollars per share) |
|
$ 0.001
|
|
$ 0.001
|
|
|
|
|
|
|
|
|
Preferred stock voting rights |
the right to cast 2,500 votes per share of Series B Preferred Stock on the December Amendment
|
|
the right to cast
2,500 votes per share of Series B Preferred Stock on the Amendment
|
|
|
|
|
|
|
|
|
|
Preferred stock subject to possible redemption |
|
$ 1,050
|
|
$ 5,250
|
|
|
|
|
|
|
|
|
Redeemable Convertible Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Price per share |
|
$ 9.50
|
|
$ 9.50
|
|
|
|
|
|
|
|
|
Percentage of issue discount |
|
5.00%
|
|
5.00%
|
|
|
|
|
|
|
|
|
Stated value per share |
|
$ 10.00
|
|
$ 10.00
|
$ 10.00
|
$ 10.00
|
|
|
|
|
|
|
Proceeds from issuance of convertible preferred stock |
|
$ 14,300
|
|
$ 28,500
|
|
|
|
|
|
|
|
|
Conversion price |
|
$ 6.25
|
|
$ 25.00
|
|
|
|
|
|
|
|
|
Preferred stock voting rights |
Preferred Stock have no voting rights other than
the right to vote on the December Amendment and as a class on certain other specified matters
|
|
Preferred Stock have no voting rights other than the right to vote on the Amendment and
as a class on certain other specified matters
|
|
|
|
|
|
|
|
|
|
Temporary equity redemption price percentage |
|
105.00%
|
|
105.00%
|
105.00%
|
105.00%
|
|
|
|
|
|
|
Escrow deposit |
|
$ 14,300
|
|
$ 28,500
|
|
|
|
|
|
|
|
|
Escrow deposit for original Issue discount |
|
$ 1,500
|
|
$ 3,000
|
|
|
|
|
|
|
|
|
Redemption amount |
|
|
|
|
$ 15,800
|
$ 31,500
|
|
|
|
|
|
|
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v3.23.3
The following unaudited pro forma consolidated financial information reflects the results of operations of the Company for the three and nine months ended September 30, 2023 and 2022 as if the USL Acquisition had occurred as of January 1, 2022 and gives e (Details) - Upsher-Smith Laboratories, LLC [Member] - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Business Acquisition [Line Items] |
|
|
|
|
Net Product Sales |
$ 3,989
|
$ 3,635
|
$ 11,610
|
$ 7,612
|
Net Loss |
$ (27,072)
|
$ (33,698)
|
$ (91,252)
|
$ (95,073)
|
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v3.23.3
ASSET PURCHASE AGREEMENT WITH UPSHER-SMITH (Details Narrative) - USD ($)
|
Jun. 30, 2023 |
Sep. 30, 2023 |
Dec. 31, 2022 |
Business Acquisition [Line Items] |
|
|
|
Goodwill |
|
$ 965,000
|
|
Upsher-Smith Laboratories, LLC [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Purchase price to be allocated |
$ 26,522,000
|
|
|
Transition services monthly base fees, first six months |
100,000
|
|
|
Transition services monthly base fees, months seven through nine |
150,000
|
|
|
Transition services additional monthly fees |
150,000
|
|
|
Closing cash consideration |
23,500,000
|
|
|
Deferred payment liability |
3,000,000
|
|
|
Goodwill |
965,000
|
|
|
Rceivables collected |
4,784,000
|
|
|
Liabilities paid |
2,724,000
|
|
|
Net amount receivable |
1,562,000
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Transition Services [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Amount due for transition services agreement |
$ 498,000
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Tosymra [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out payment percentage reduction upon entry of generic product |
66.70%
|
|
|
Additional royalty percentage |
3.00%
|
|
|
Additional royalty percentage for U.S. patent |
3.00%
|
|
|
Additional royalty payment period |
15 years
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Tosymra [Member] | Earn-Out Range 1 [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out payment percentage |
4.00%
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Tosymra [Member] | Earn-Out Range 1 [Member] | Minimum [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out net sales |
$ 0
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Tosymra [Member] | Earn-Out Range 1 [Member] | Maximum [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out net sales |
$ 30,000,000
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Tosymra [Member] | Earn-Out Range 2 [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out payment percentage |
7.00%
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Tosymra [Member] | Earn-Out Range 2 [Member] | Minimum [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out net sales |
$ 30,000,000
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Tosymra [Member] | Earn-Out Range 2 [Member] | Maximum [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out net sales |
$ 75,000,000
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Tosymra [Member] | Earn-Out Range 3 [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out payment percentage |
9.00%
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Tosymra [Member] | Earn-Out Range 3 [Member] | Minimum [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out net sales |
$ 75,000,000
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Tosymra [Member] | Earn-Out Range 3 [Member] | Maximum [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out net sales |
$ 100,000,000
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Tosymra [Member] | Earn-Out Range 4 [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out payment percentage |
12.00%
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Tosymra [Member] | Earn-Out Range 4 [Member] | Minimum [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out net sales |
$ 100,000,000
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Tosymra [Member] | Earn-Out Range 4 [Member] | Maximum [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out net sales |
$ 150,000,000
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Tosymra [Member] | Earn-Out Range 5 [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out payment percentage |
15.00%
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Tosymra [Member] | Earn-Out Range 5 [Member] | Minimum [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out net sales |
$ 150,000,000
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Tosymra [Member] | Sales Milestones [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Maximum payment for sales milestones |
$ 15,000,000
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Zembrace Symtouch [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out payment percentage reduction upon entry of generic product |
90.00%
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Zembrace Symtouch [Member] | Earn-Out Range 1 [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out payment percentage |
3.00%
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Zembrace Symtouch [Member] | Earn-Out Range 1 [Member] | Minimum [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out net sales |
$ 0
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Zembrace Symtouch [Member] | Earn-Out Range 1 [Member] | Maximum [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out net sales |
$ 30,000,000
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Zembrace Symtouch [Member] | Earn-Out Range 2 [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out payment percentage |
6.00%
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Zembrace Symtouch [Member] | Earn-Out Range 2 [Member] | Minimum [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out net sales |
$ 30,000,000
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Zembrace Symtouch [Member] | Earn-Out Range 2 [Member] | Maximum [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out net sales |
$ 75,000,000
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Zembrace Symtouch [Member] | Earn-Out Range 3 [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out payment percentage |
12.00%
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Zembrace Symtouch [Member] | Earn-Out Range 3 [Member] | Minimum [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out net sales |
$ 75,000,000
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Zembrace Symtouch [Member] | Earn-Out Range 3 [Member] | Maximum [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out net sales |
$ 100,000,000
|
|
|
Upsher-Smith Laboratories, LLC [Member] | Zembrace Symtouch [Member] | Earn-Out Range 4 [Member] |
|
|
|
Business Acquisition [Line Items] |
|
|
|
Earm-out payment percentage |
16.00%
|
|
|
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v3.23.3
SALE OF COMMON STOCK (Details Narrative) - USD ($)
|
|
|
|
|
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
Aug. 01, 2023 |
Jul. 27, 2023 |
Aug. 16, 2022 |
Dec. 03, 2021 |
Apr. 08, 2020 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued, value |
|
|
|
|
|
|
|
$ 1,029,000
|
|
|
|
Repurchase of common stock |
|
|
|
|
|
|
|
|
|
$ 13,965,000
|
|
2022 Share Repurchase Program [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Shares repurchased |
|
|
|
|
|
|
|
|
2,512,044
|
|
|
Share repurchase authorized amount |
|
|
|
|
|
|
|
|
$ 12,500,000
|
|
|
Repurchase of common stock |
|
|
|
|
|
|
|
|
12,500,000
|
|
|
Stock repurchase agreement expense |
|
|
|
|
|
|
|
|
$ 300,000
|
|
|
2022 Share Repurchase Program [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Price per share |
|
|
|
|
|
|
|
|
$ 2.75
|
|
|
2022 Share Repurchase Program [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Price per share |
|
|
|
|
|
|
|
|
$ 8.61
|
|
|
2023 Share Repurchase Program [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Shares repurchased |
|
|
|
|
|
|
|
|
160,000
|
|
|
Share repurchase authorized amount |
|
|
|
|
|
|
|
|
$ 12,500,000
|
|
|
Price per share |
|
|
|
|
|
|
|
|
$ 7.12
|
|
|
Repurchase of common stock |
|
|
|
|
|
|
|
|
$ 1,100,000
|
|
|
Sales Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
2,530,000
|
|
|
|
|
|
|
|
|
|
Stock offering expenses |
$ 700,000
|
|
|
|
|
|
|
|
|
|
|
Placement agent fees |
500,000
|
|
|
|
|
|
|
|
|
|
|
Proceeds from equity offerings |
$ 6,300,000
|
|
|
|
|
|
|
|
|
|
|
Sales Agreement [Member] | Alliance Global Partners [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
|
|
|
0
|
|
|
1,000,000
|
5,500,000
|
Proceeds from equity offerings |
|
|
|
|
|
|
$ 0
|
|
|
$ 3,000,000
|
$ 76,200,000
|
Offering price per agreement |
|
|
|
|
$ 320,000,000
|
|
|
|
|
|
|
Commission to agent |
|
|
|
|
3.00%
|
|
|
|
|
|
|
Sales Agreement [Member] | Pre-Funded Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of shares for common warramts |
|
4,470,000
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
$ 0.0001
|
|
|
|
|
|
|
|
|
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Price per share |
|
$ 0.9999
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|
|
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|
|
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|
|
Sales Agreement [Member] | Common Warrants [Member] |
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|
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Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of shares for common warramts |
|
7,000,000
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
$ 1.00
|
|
|
|
|
|
|
|
|
|
Price per share |
|
$ 1.00
|
|
|
|
|
|
|
|
|
|
Purchase Agreement with Lincoln Park 2022 [Member] |
|
|
|
|
|
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|
|
|
|
|
Class of Stock [Line Items] |
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|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
|
|
|
0
|
|
|
100,000
|
0
|
Proceeds from equity offerings |
|
|
|
|
|
|
$ 0
|
|
|
$ 400,000
|
|
Purchase Agreement with Lincoln Park 2022 [Member] | Lincoln Park Capital Fund, LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
100,000
|
|
|
|
|
|
|
|
|
Commitment to purchase shares under agreement |
|
|
$ 50,000,000
|
|
|
|
|
|
|
|
|
Number of shares issued, value |
|
|
$ 1,000,000
|
|
|
|
|
|
|
|
|
Purchase Agreement with Lincoln Park [Member] |
|
|
|
|
|
|
|
|
|
|
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Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
|
|
400,000
|
|
|
|
|
500,000
|
Proceeds from equity offerings |
|
|
|
|
|
|
|
|
|
|
$ 8,700,000
|
Percentage of issuance by issuer of common stock |
|
|
|
|
|
|
|
|
|
19.99%
|
|
Maximum number of shares issued wIthout shareholder approval |
|
|
|
|
|
|
|
|
|
500,000
|
|
Purchase Agreement with Lincoln Park [Member] | Lincoln Park Capital Fund, LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
14,546
|
|
|
|
|
|
|
|
Commitment to purchase shares under agreement |
|
|
|
$ 80,000,000
|
|
|
|
|
|
|
|
Number of shares issued, value |
|
|
|
$ 1,600,000
|
|
|
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|
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v3.23.3
STOCK-BASED COMPENSATION (Details Narrative) - USD ($)
|
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
May 03, 2019 |
Jan. 31, 2023 |
Jan. 31, 2022 |
Sep. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2022 |
Mar. 31, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
May 01, 2020 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
Weighted average grant date fair value of options (in dollars per share) |
|
|
|
$ 0.84
|
|
$ 0
|
|
$ 3.99
|
$ 32.81
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
Expiration period |
|
|
|
|
|
|
|
10 years
|
|
|
Stock-based compensation expense |
|
|
|
$ 2,100,000
|
|
$ 2,700,000
|
|
$ 7,200,000
|
$ 8,100,000
|
|
Unrecognized compensation cost |
|
|
|
8,200,000
|
|
|
|
$ 8,200,000
|
|
|
Unrecognized compensation cost, recognition period |
|
|
|
|
|
|
|
1 year 8 months 26 days
|
|
|
Share-Based Payment Arrangement, Option [Member] | General and Administrative Expense [Member] |
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
|
|
1,400,000
|
|
2,000,000
|
|
$ 5,000,000
|
5,900,000
|
|
Share-Based Payment Arrangement, Option [Member] | Research and Development Expense [Member] |
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
|
|
$ 700,000
|
|
700,000
|
|
$ 2,200,000
|
2,200,000
|
|
Share-Based Payment Arrangement, Option [Member] | Director [Member] |
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
Vesting period |
|
|
|
|
|
|
|
1 year
|
|
|
Share-Based Payment Arrangement, Option [Member] | Executive Officer [Member] |
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
Service period |
|
|
|
|
|
|
|
1 year
|
|
|
Share-Based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Tranche One [Member] |
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
Vesting percentage |
|
|
|
|
|
|
|
33.33%
|
|
|
Share-Based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Tranche Two [Member] |
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
Vesting percentage |
|
|
|
|
|
|
|
2.78%
|
|
|
Amended and Restated 2020 Plan [Member] |
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
Number of shares authorized |
|
|
|
|
|
|
|
|
|
50,000
|
Percentage of additional shares authorized |
|
|
|
|
|
|
|
20.00%
|
|
|
Percent of fair value of common stock at grant date |
|
|
|
|
|
|
|
100.00%
|
|
|
Expiration period |
|
|
|
|
|
|
|
10 years
|
|
|
Number of shares available for future grants |
|
|
|
1,062,874
|
|
|
|
1,062,874
|
|
|
Amended and Restated 2020 Plan [Member] | 10% or more Shareholder [Member] |
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
Percent of fair value of common stock at grant date |
|
|
|
|
|
|
|
110.00%
|
|
|
2023 Employee Stock Purchase Plan [Member] |
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
Number of shares authorized |
800,000
|
|
|
|
|
|
|
|
|
|
Percent of fair value of common stock at grant date |
85.00%
|
|
|
|
|
|
|
|
|
|
Number of shares available for future grants |
|
|
|
800,000
|
|
|
|
800,000
|
|
|
Accrued expenses |
|
|
|
$ 32,000
|
|
|
|
$ 32,000
|
|
|
Employee Stock Purchase Plan [Member] |
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
|
|
$ 34,000
|
|
$ 46,000
|
|
$ 34,000
|
$ 46,000
|
|
2020 Employee Stock Purchase Plan [Member] |
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
Employee stock purchase plan (in shares) |
|
|
646
|
|
|
|
|
|
|
|
Transfer to additional paid in capital |
|
|
|
|
|
|
$ 40,000
|
|
|
|
ESPP withholdings returned to employees |
|
|
|
|
|
|
$ 30,000
|
|
|
|
2022 Employee Stock Purchase Plan [Member] |
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
Employee stock purchase plan (in shares) |
|
14,999
|
|
|
|
|
|
|
|
|
Transfer to additional paid in capital |
|
|
|
|
$ 29,000
|
|
|
|
|
|
ESPP withholdings returned to employees |
|
|
|
|
$ 14,000
|
|
|
|
|
|
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v3.23.3
At September 30, 2023, future minimum lease payments for operating leases with non-cancelable terms of more than one year were as follows (in thousands): (Details) $ in Thousands |
Sep. 30, 2023
USD ($)
|
Leases |
|
2023 |
$ 107
|
2024 |
460
|
2025 |
299
|
2026 |
142
|
2027 and beyond |
246
|
|
1,254
|
Included interest |
(104)
|
|
$ 1,150
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v3.23.3
LEASES (Details Narrative) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Other Commitments [Line Items] |
|
|
|
|
|
Right-of-use assets, net |
$ 1,081
|
|
$ 1,081
|
|
$ 715
|
Total lease liability |
1,150
|
|
1,150
|
|
|
Lease liability, net of current portion |
716
|
|
716
|
|
328
|
Lease liability, current |
434
|
|
434
|
|
$ 432
|
Operating lease expense |
100
|
$ 100
|
400
|
$ 400
|
|
New Operating Lease [Member] |
|
|
|
|
|
Other Commitments [Line Items] |
|
|
|
|
|
Right-of-use assets, net |
898
|
386
|
898
|
386
|
|
Total lease liability |
$ 898
|
$ 386
|
$ 898
|
$ 386
|
|
X |
- DefinitionAmount of operating lease expense. Excludes sublease income.
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v3.23.3
SUBSEQUENT EVENTS (Details Narrative) - USD ($) $ / shares in Units, $ in Millions |
Oct. 17, 2023 |
Oct. 03, 2023 |
Aug. 01, 2023 |
Jul. 27, 2023 |
Sales Agreement [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Number of shares issued |
|
|
|
2,530,000
|
Stock offering expenses |
|
|
$ 0.7
|
|
Placement agent fees |
|
|
0.5
|
|
Proceeds from equity offerings |
|
|
$ 6.3
|
|
Sales Agreement [Member] | Pre-Funded Warrants [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Number of shares for common warramts |
|
|
|
4,470,000
|
Exercise price |
|
|
|
$ 0.0001
|
Price per share |
|
|
|
$ 0.9999
|
Subsequent Event [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Nasdaq minimum bid requirement |
$ 1
|
|
|
|
Period to regain compiance with minimum bid requirement |
180 days
|
|
|
|
Additional period to regain compiance with minimum bid requirement |
180 days
|
|
|
|
Subsequent Event [Member] | Sales Agreement [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Number of shares issued |
|
4,050,000
|
|
|
Stock offering expenses |
|
$ 0.5
|
|
|
Placement agent fees |
|
0.3
|
|
|
Proceeds from equity offerings |
|
$ 4.0
|
|
|
Subsequent Event [Member] | Sales Agreement [Member] | Pre-Funded Warrants [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Number of shares for common warramts |
|
4,950,000
|
|
|
Price per share |
|
$ 0.4999
|
|
|
Subsequent Event [Member] | Sales Agreement [Member] | Common Warrants Series A [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Number of shares for common warramts |
|
9,000,000
|
|
|
Exercise price |
|
$ 0.50
|
|
|
Warrants term |
|
5 years
|
|
|
Price per share |
|
$ 0.4999
|
|
|
Subsequent Event [Member] | Sales Agreement [Member] | Common Warrants Series B [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Number of shares for common warramts |
|
9,000,000
|
|
|
Exercise price |
|
$ 0.50
|
|
|
Warrants term |
|
1 year
|
|
|
Price per share |
|
$ 0.50
|
|
|
X |
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Tonix Pharmaceuticals (NASDAQ:TNXP)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024
Tonix Pharmaceuticals (NASDAQ:TNXP)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024