Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 13, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2022 | ||
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 | 799-8599 | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Trading Symbol | TNXP | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity public float | $ 50,022,154 | ||
Entity common stock, shares outstanding | 62,539,497 | ||
Auditor Name | EisnerAmper LLP | ||
Auditor Location | Iselin, New Jersey | ||
Auditor Firm ID | 274 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 120,229 | $ 178,660 |
Prepaid expenses and other | 10,548 | 10,389 |
Total current assets | 130,777 | 189,049 |
Property and equipment, net | 93,814 | 50,558 |
Operating lease right-to-use assets | 715 | 914 |
Other non-current assets | 384 | 379 |
Total assets | 225,690 | 240,900 |
Current liabilities: | ||
Accounts payable | 8,068 | 13,282 |
Accrued expenses and other current liabilities | 9,680 | 7,945 |
Lease liability, short term | 432 | 489 |
Total current liabilities | 18,180 | 21,716 |
Lease liability, long term | 328 | 467 |
Total liabilities | 18,508 | 22,183 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized Series B Convertible Preferred stock, 0 shares designated as of both December 31, 2022 and 2021; issued and outstanding - None Series A Convertible Preferred stock, 0 shares designated as of both December 31, 2022 and 2021; issued and outstanding - None | ||
Common stock, $0.001 par value; 1,000,000,000 and 25,000,000 shares authorized as of December 31, 2022 and 2021, respectively; 76,478,656 and 15,638,274 shares issued and outstanding as of December 31, 2022 and 2021, respectively and 93,741 and 4,033 shares to be issued as of December 31, 2022 and December 31, 2021, respectively | 76 | 16 |
Additional paid in capital | 677,311 | 578,613 |
Accumulated deficit | (470,038) | (359,820) |
Accumulated other comprehensive loss | (167) | (92) |
Total stockholders’ equity | 207,182 | 218,717 |
Total liabilities and stockholders’ equity | $ 225,690 | $ 240,900 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
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 | 1,000,000,000 | 25,000,000 |
Common stock, issued | 76,478,656 | 15,638,274 |
Common stock, outstanding | 76,478,656 | 15,638,274 |
Common stock, to be issued | 93,741 | 4,033 |
Series B Preferred Stock [Member] | ||
Preferred stock, designated | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Preferred stock, issued | 0 | 0 |
Series A Preferred Stock [Member] | ||
Preferred stock, designated | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Preferred stock, issued | 0 | 0 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
COSTS AND EXPENSES: | ||
Research and development | $ 81,876 | $ 68,838 |
General and administrative | 30,215 | 23,474 |
112,091 | 92,312 | |
Operating loss | (112,091) | (92,312) |
Interest income | 1,873 | 25 |
Net loss | (110,218) | (92,287) |
Preferred stock deemed dividend | 6,659 | |
Net loss available to common stockholders | $ (116,877) | $ (92,287) |
Net loss per common share, basic | $ (3.27) | $ (8.10) |
Net loss per common share, diluted | $ (3.27) | $ (8.10) |
Weighted average common shares outstanding, basic | 35,739,057 | 11,387,308 |
Weighted average common shares outstanding, diluted | 35,739,057 | 11,387,308 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | ||
Net loss | $ (110,218) | $ (92,287) |
Other comprehensive loss: | ||
Foreign currency translation loss | (75) | (30) |
Comprehensive loss | $ (110,293) | $ (92,317) |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - 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, 2020 | $ 6 | $ 355,237 | $ (62) | $ (267,533) | $ 87,648 |
Balance, at beginning (in shares) at Dec. 31, 2020 | 6,568,335 | ||||
Issuance of common stock in January 2021 ($25.60 per share), net of transactional expenses of $3,096 | $ 2 | 36,902 | 36,904 | ||
Issuance of common stock in January 2021 ($25.60 per share), net of transactional expenses of $3,096 (in shares) | 1,562,500 | ||||
Issuance of common stock in exchange for exercise of warrants in March 2021 ($18.24 per share) | 2 | 2 | |||
Issuance of common stock in exchange for exercise of warrants in March 2021 ($18.24 per share) (in shares) | 107 | ||||
Issuance of common stock in February 2021 ($38.40 per share), net of transactional expenses of $5,002 | $ 2 | 64,995 | 64,997 | ||
Issuance of common stock in February 2021 ($38.40 per share), net of transactional expenses of $5,002 (in shares) | 1,822,917 | ||||
Issuance of common stock under At-the-market offering, net of transactional expenses of $2,332 | $ 4 | 69,288 | 69,292 | ||
Issuance of common stock under At-the-market offering, net of transactional expenses of $2,332 (in shares) | 3,445,297 | ||||
Issuance of common stock under 2021 Purchase Agreement, net of transactional expenses of $75 | $ 2 | 41,194 | 41,196 | ||
Issuance of common stock under 2021 Purchase Agreement, net of transactional expenses of $75 (in shares) | 2,016,855 | ||||
Issuance of commitment shares under 2021 Purchase agreement | |||||
Issuance of commitment shares under 2021 Purchase agreement (in shares) | 40,000 | ||||
Issuance of common stock in the acquisition of the OyaGen license | 3,000 | 3,000 | |||
Issuance of common stock in the acquisition of the OyaGen license (in shares) | 86,010 | ||||
Issuance of commitment shares under Lincoln park Purchase agreement | |||||
Issuance of commitment shares under Lincoln park Purchase agreement (in shares) | 90,909 | ||||
Employee stock purchase plan | 96 | 96 | |||
Employee stock purchase plan (in shares) | 5,344 | ||||
Stock-based compensation | 7,899 | 7,899 | |||
Foreign currency transaction loss | (30) | (30) | |||
Net loss | (92,287) | (92,287) | |||
Ending balance, value at Dec. 31, 2021 | $ 16 | 578,613 | (92) | (359,820) | 218,717 |
Balance, at end (in shares) at Dec. 31, 2021 | 15,638,274 | ||||
Issuance of common stock under At-the-market offering, net of transactional expenses of $3,078 | $ 56 | 85,237 | 85,293 | ||
Issuance of common stock under At-the-market offering, net of transactional expenses of $3,078 (in shares) | 56,357,869 | ||||
Issuance of common stock under 2022 Purchase Agreement | $ 1 | 487 | 488 | ||
Issuance of common stock under 2022 Purchase Agreement (in shares) | 1,000,000 | ||||
Issuance of common stock under 2021 Purchase Agreement | $ 3 | 8,679 | 8,682 | ||
Issuance of common stock under 2021 Purchase Agreement (in shares) | 2,853,480 | ||||
Issuance of commitment shares under 2022 Purchase agreement | |||||
Issuance of commitment shares under 2022 Purchase agreement (in shares) | 625,000 | ||||
Preferred stock deemed dividend | (6,659) | (6,659) | |||
Employee stock purchase plan | 40 | 40 | |||
Employee stock purchase plan (in shares) | 4,033 | ||||
Stock-based compensation | 10,914 | 10,914 | |||
Foreign currency transaction loss | (75) | (75) | |||
Net loss | (110,218) | (110,218) | |||
Ending balance, value at Dec. 31, 2022 | $ 76 | $ 677,311 | $ (167) | $ (470,038) | $ 207,182 |
Balance, at end (in shares) at Dec. 31, 2022 | 76,478,656 |
CONSOLIDATED STATEMENTS OF ST_2
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Subsidiary, Sale of Stock [Line Items] | ||
Warrants exercise price (in dollars per share) | $ 18.24 | |
Issuance of common stock under At-the-market offering [Member] | ||
Subsidiary, Sale of Stock [Line Items] | ||
Transactional expenses | $ 3,078 | $ 2,332 |
Issuance of common stock in January 2021 [Member] | ||
Subsidiary, Sale of Stock [Line Items] | ||
Transactional expenses | $ 3,096 | |
Price per share | $ 25.60 | |
Issuance of common stock in February 2021 [Member] | ||
Subsidiary, Sale of Stock [Line Items] | ||
Transactional expenses | $ 5,002 | |
Price per share | $ 38.40 | |
Issuance of common stock under 2021 Purchase Agreement [Member] | ||
Subsidiary, Sale of Stock [Line Items] | ||
Transactional expenses | $ 75 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (110,218) | $ (92,287) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,253 | 50 |
Common stock issued to acquire in-process research and development | 3,000 | |
Stock-based compensation | 10,914 | 7,899 |
Changes in operating assets and liabilities: | ||
Prepaid expenses | (164) | 518 |
Accounts payable | (1,045) | 3,526 |
Lease liabilities and ROU asset, net | 2 | (11) |
Accrued expenses and other current liabilities | 1,205 | 1,748 |
Net cash used in operating activities | (98,053) | (75,557) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (48,147) | (35,307) |
Net cash used in investing activities | (48,147) | (35,307) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from exercise of warrants | 2 | |
Proceeds from ESPP | 40 | 96 |
Proceeds, net of $6,659 expenses, from sale of convertible redeemable preferred stock | 40,591 | |
Redemption of convertible redeemable preferred stock | (47,250) | |
Proceeds, net of $3,078 and $10,505 expenses, from sale of common stock and warrants | 94,463 | 212,389 |
Net cash provided by financing activities | 87,844 | 212,487 |
Effect of currency rate change on cash | (74) | (31) |
Net (decrease) increase in cash, cash equivalents and restricted cash | (58,430) | 101,592 |
Cash, cash equivalents and restricted cash beginning of the period | 178,900 | 77,308 |
Cash, cash equivalents and restricted cash end of period | 120,470 | 178,900 |
Supplemental disclosures of cash flow information: | ||
Purchases of property and equipment included in accounts payable and accrued liabilities | 3,092 | 6,730 |
Preferred stock deemed dividend | $ 6,659 |
CONSOLIDATED STATEMENTS OF CA_2
CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Common Stock [Member] | ||
Expenses from sale of common stock and warrants | $ 3,078 | $ 10,505 |
Redeemable Convertible Preferred Stock [Member] | ||
Expenses from sale of common stock and warrants | $ 6,659 |
BUSINESS
BUSINESS | 12 Months Ended |
Dec. 31, 2022 | |
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 clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and vaccines to treat and prevent human disease and alleviate suffering. The therapeutics include both small molecules and biologics. All drug product and vaccine candidates are still in development and none are approved or marketed. The 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 December 31, 2022, the Company had working capital of approximately $ 112.6 470.0 million 120.2 million The Company believes that its cash resources at December 31, 2022 and the proceeds that it raised from equity offerings in the first quarter of 2023, net of amounts paid to repurchase shares in the first quarter of 2023 (See Note 22), will meet its operating and capital expenditure requirements into the fourth quarter of 2023, but not beyond. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The Company faces significant challenges and uncertainties and, as a result, its available capital resources may be consumed more rapidly than currently expected due to changes it may make in its research and development spending plans. The Company believes that it has the ability to 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. 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, the Company’s ability to achieve its development and commercialization goals would be adversely affected. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES Reverse Stock Split On May 16, 2022, the Company filed a Certificate of Change with the Nevada Secretary of State, effective May 17, 2022. Pursuant to the Certificate of Change, the Company effected a 1-for-32 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 does not have any commercial products available for sale and has not generated revenues, and there is no assurance that if its products are approved for sale, that the Company will be able to generate cash flow to fund operations. 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. Moreover, the extent to which COVID-19 impacts the Company’s operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence at this time. 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 the assumptions used in the fair value of stock-based compensation and other equity instruments, and the percent of completion of research and development contracts. 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 December 31, 2022 and December 31, 2021, cash equivalents, which consisted of money market funds, amounted to $ 116.3 120.4 241,000 240,000 The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statement of cash flows: December 31, 2022 December 31, 2021 (in thousands) Cash and cash equivalents $ 120,229 $ 178,660 Restricted cash 241 240 Total $ 120,470 $ 178,900 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 30 15 three years five years 1,253,000 50,000 Intangible assets with indefinite lives 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 Other non-current assets on the 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 December 31, 2022, and 2021, the Company believed that no impairment existed. 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, lease liability, short term and lease liability, long term in the Company’s 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. 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. No funding was received during 2022. 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 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 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 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 December 31, 2022, 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 years ended December 31, 2022 and 2021 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 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 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 for the years ended December 31, 2022 and 2021, as results of operations were a loss for the period. Potentially dilutive securities excluded from the computation of basic and diluted net loss per share, as of December 31, 2022 and 2021, are as follows: 2022 2021 Warrants to purchase common stock 19,970 19,970 Options to purchase common stock 2,453,031 805,762 Totals 2,473,001 825,732 Recently Issued 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 |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT, NET | NOTE 3 – PROPERTY AND EQUIPMENT, NET Property and equipment, net consisted of the following (in thousands): December 31 December 31 2022 2021 (in thousands) Property and equipment, net: Land $ 8,011 $ 7,911 Land improvements 79 — Buildings 65,644 — Office furniture and equipment 1,893 756 Laboratory equipment 18,440 347 Leasehold improvements 34 23 Construction in progress 1,366 41,921 95,467 50,958 Less: Accumulated depreciation and amortization (1,653 ) (400 ) $ 93,814 $ 50,558 On October 1, 2021, the Company completed the acquisition of its approximately 45,000 17.5 2.1 13.9 1.5 On September 28, 2020, the Company completed the purchase of its approximately 45,000 4 1.2 2.8 38.8 61.6 On December 23, 2020, the Company completed the purchase of its approximately 44 4.5 |
OTHER BALANCE SHEET INFORMATION
OTHER BALANCE SHEET INFORMATION | 12 Months Ended |
Dec. 31, 2022 | |
Other Balance Sheet Information | |
OTHER BALANCE SHEET INFORMATION | NOTE 4 – OTHER BALANCE SHEET INFORMATION Components of selected captions in the consolidated balance sheets consist of: December 31, 2022 2021 (in thousands) Prepaid expenses and other: Contract-related $ 8,043 $ 7,726 Insurance 1,275 1,482 Other 1,230 1,181 $ 10,548 $ 10,389 Accrued expenses and other current liabilities: Contract-related $ 3,273 $ 2,832 Compensation and compensation-related 3,645 2,868 Construction in progress 2,103 1,572 Professional fees and other 659 673 $ 9,680 $ 7,945 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 5 – 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 December 31, 2022, and December 31, 2021, the Company used Level 1 quoted prices in active markets to value cash equivalents of $ 116.3 120.4 |
STOCKHOLDERS_ EQUITY
STOCKHOLDERS’ EQUITY | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY | NOTE 6 – STOCKHOLDERS’ EQUITY On May 16, 2022, the Company filed a Certificate of Change with the Nevada Secretary of State, effective May 17, 2022. Pursuant to the Certificate of Change, the Company effected a 1-for-32 599,679,596 18,740,141 130,462 800 50 On August 5, 2022, the Company filed an amendment to its articles of incorporation, as amended, to increase the number of shares of common stock authorized from 50,000,000 150,000,000 On December 13, 2022, the Company filed an amendment to its articles of incorporation, as amended, to increase the number of shares of common stock authorized from 150,000,000 1,000,000,000 |
TEMPORARY EQUITY
TEMPORARY EQUITY | 12 Months Ended |
Dec. 31, 2022 | |
Temporary Equity | |
TEMPORARY EQUITY | NOTE 7 – 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 0.001 100,000 0.001 9.50 5% 10.00 14.3 1.00 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 150,000,000 1,000,000,000 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 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 $ 1.00 105% 105% The $ 14.3 1.5 105% 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 14.7 1.1 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% 10.00 15.8 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 0.001 500,000 0.001 9.50 5% 10.00 28.5 4.00 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 50,000,000 150,000,000 Preferred Stock have no voting rights other than the right to vote on the Amendment and as a class on certain other specified matters 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 $ 4.00 105% 105% The $ 28.5 3 105% 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 5.2 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% 10.00 31.5 |
ASSET PURCHASE AGREEMENT WITH K
ASSET PURCHASE AGREEMENT WITH KATANA | 12 Months Ended |
Dec. 31, 2022 | |
Asset Purchase Agreement With Katana | |
ASSET PURCHASE AGREEMENT WITH KATANA | NOTE 8 – ASSET PURCHASE AGREEMENT WITH KATANA On December 22, 2020, the Company entered into an asset purchase agreement (the “Katana Asset Purchase Agreement”) with Katana Pharmaceuticals, Inc. (“Katana”) pursuant to which Tonix acquired Katana assets related to insulin resistance and related syndromes, including obesity (the “Katana Assets”). In connection with the acquisition of the Katana Assets, Tonix assumed Katana’s rights and obligations under that certain Exclusive License Agreement by and between Katana and The University of Geneva (“Geneva”) (the “Geneva License “Agreement”) pursuant to an Assignment and Assumption Agreement with Geneva (“Geneva Assignment and Assumption Agreement”), dated December 22, 2020. As consideration for entering into the Katana Asset Purchase Agreement, Tonix paid $ 0.7 0.7 Pursuant to the terms of the Geneva Assignment and Assumption Agreement, Geneva has granted to Tonix an exclusive license, with the right to sublicense, certain patents related to the Katana Assets. Tonix is obligated to use commercially reasonable efforts to diligently develop, manufacture, and sell products claimed or covered by the patent and will use commercially reasonable efforts to diligently develop markets for such products. The Geneva License Agreement specifies developmental milestones and the period of time during which such milestones must be completed and provides for an annual maintenance fee payable to Geneva. As of December 31, 2022, no milestone payments have been accrued or paid in relation to this agreement. |
ASSET PURCHASE AGREEMENT WITH T
ASSET PURCHASE AGREEMENT WITH TRIGEMINA | 12 Months Ended |
Dec. 31, 2022 | |
Asset Purchase Agreement With Trigemina | |
ASSET PURCHASE AGREEMENT WITH TRIGEMINA | NOTE 9 – ASSET PURCHASE AGREEMENT WITH TRIGEMINA On June 11, 2020, the Company entered into an asset purchase agreement (the “Trigemina Asset Purchase Agreement”) with Trigemina, Inc. (“Trigemina”) and certain shareholders named therein (the “Executive Shareholders”) pursuant to which Tonix acquired Trigemina assets related to migraine and pain treatment technologies (the “Trigemina Assets”). In connection with the acquisition of the Trigemina Assets, Tonix assumed Trigemina’s rights and obligations under that certain Amended and Restated Exclusive License Agreement, dated November 30, 2007, as amended, by and between Trigemina and The Board of Trustees of the Leland Stanford Junior University (“Stanford”) (the “Stanford License “Agreement”) pursuant to an Assignment and Assumption Agreement with Stanford (“Assignment and Assumption Agreement”), dated June 11, 2020. As consideration for entering into the Asset Purchase Agreement, Tonix paid $ 824,759 62,500 21.76 250,241 2.4 Pursuant to the terms of the Assignment and Assumption Agreement, Stanford has granted to Tonix an exclusive license, with the right to sublicense, certain patents related to the Trigemina Assets. Stanford has reserved for itself the right to practice under the patents for academic research and educational purposes. Tonix is obligated to use commercially reasonable efforts to diligently develop, manufacture, and sell products claimed or covered by the patent and will use commercially reasonable efforts to diligently develop markets for such products. The Trigemina License Agreement specifies developmental milestones and the period of time during which such milestones must be completed and provides for an annual maintenance fee payable to Stanford. As of December 31, 2022, other than the annual maintenance fee, no milestone payments have been accrued or paid in relation to this agreement. |
ASSET PURCHASE AGREEMENT WITH_2
ASSET PURCHASE AGREEMENT WITH TRIMARAN | 12 Months Ended |
Dec. 31, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
ASSET PURCHASE AGREEMENT WITH TRIMARAN | NOTE 10 – ASSET PURCHASE AGREEMENT WITH TRIMARAN On August 19, 2019, the Company entered into an asset purchase agreement (the “Asset Purchase Agreement”) with TRImaran Pharma, Inc. (“TRImaran”) and the selling shareholders named therein (the “Selling Shareholders”) pursuant to which Tonix acquired TRImaran’s assets related to certain pyran-based compounds (the “Assets”). In connection with the acquisition of the Assets, Tonix entered into a First Amended and Restated Exclusive License Agreement (the “WSU License Agreement”) with Wayne State University (“WSU”) on August 19, 2019, as subsequently amended. As consideration for entering into the Asset Purchase Agreement, Tonix paid $ 100,000 68,500 168,500 3.4 Pursuant to the terms of the WSU License Agreement, WSU has granted to Tonix an exclusive license, with the right to sublicense, certain patents, technical information and material (collectively, the “Technology”) related to the Assets. WSU has reserved for itself the right to practice the Technology for academic research and educational purposes. Tonix is obligated to use commercially reasonable efforts to obtain regulatory approval for one or more products utilizing the Technology (“WSU Products”) and to use commercially reasonable marketing efforts throughout the term of the WSU License Agreement. The WSU License Agreement specifies developmental milestones and the period of time during which such milestones must be completed and provides for an annual maintenance fee payable to WSU. Tonix is obligated to substantially manufacture WSU Products in the United States if WSU Products will be sold in the United States. Pursuant to the WSU License Agreement, Tonix paid $ 75,000 3.4 50 50 |
LICENSE AGREEMENT WITH CURIA
LICENSE AGREEMENT WITH CURIA | 12 Months Ended |
Dec. 31, 2022 | |
License Agreement With Curia | |
LICENSE AGREEMENT WITH CURIA | NOTE 11 – 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 |
LICENSE AGREEMENT WITH UNIVERSI
LICENSE AGREEMENT WITH UNIVERSITY OF ALBERTA | 12 Months Ended |
Dec. 31, 2022 | |
License Agreement With University Of Alberta | |
LICENSE AGREEMENT WITH UNIVERSITY OF ALBERTA | NOTE 12 – 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 December 31, 2022, other than the upfront fee, no milestone payments have been accrued or paid in relation to this agreement. |
LICENSE AGREEMENT WITH OYAGEN
LICENSE AGREEMENT WITH OYAGEN | 12 Months Ended |
Dec. 31, 2022 | |
License Agreement With Oyagen | |
LICENSE AGREEMENT WITH OYAGEN | NOTE 13 – LICENSE AGREEMENT WITH OYAGEN On April 14, 2021, the Company and OyaGen, Inc. (“OyaGen”) entered into an exclusive License Agreement (the “OyaGen License Agreement”) pursuant to which OyaGen granted to Tonix an exclusive license to certain patents and technical information related to an antiviral inhibitor of SARS-CoV-2, sangivamycin, and to develop and commercialize products thereunder, and to acquire rights to any technology based thereon for the prevention or treatment of COVID-19 developed by OyaGen during the term of the License Agreement. As consideration for entering into the License Agreement, Tonix paid a low-seven digit license fee to OyaGen, and issued to OyaGen and an affiliated entity an aggregate of 86,010 3 |
LICENSE AGREEMENT WITH INSERM
LICENSE AGREEMENT WITH INSERM | 12 Months Ended |
Dec. 31, 2022 | |
License Agreement With Inserm | |
LICENSE AGREEMENT WITH INSERM | NOTE 14 – LICENSE AGREEMENT WITH INSERM On February 11, 2021, the Company entered into a license agreement (the “Inserm License Agreement”) pursuant to which it licensed technology using oxytocin-based therapeutics for the treatment of Prader-Willi syndrome and non-organic failure to thrive disease from Inserm (the French National Institute of Health and Medical Research), Aix-Marseille Université and Centre Hospitalier Universitaire of Toulouse. The Inserm License Agreement provides for the payment of annual fees and milestone payments upon the occurrence of specified sales milestones totaling approximately $ 0.4 |
LICENSE AGREEMENTS WITH COLUMBI
LICENSE AGREEMENTS WITH COLUMBIA UNIVERSITY | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
LICENSE AGREEMENTS WITH COLUMBIA UNIVERSITY | NOTE 15 – LICENSE AGREEMENTS WITH COLUMBIA UNIVERSITY On September 16, 2019, the Company entered into an exclusive License Agreement (the “Columbia License Agreement”) with the Trustees of Columbia University in the City of New York (“Columbia”), as subsequently amended, pursuant to which Columbia granted to Tonix an exclusive license, with the right to sublicense, certain patents and technical information (collectively, the “TFF2 Technology”) related to a recombinant Trefoil Family Factor 2 (TFF2), and to develop and commercialize products thereunder (each, a “TFF2 Product”). Pursuant to the terms of the Columbia License Agreement, Columbia reserved for itself the right to practice the TFF2 Technology for academic research and educational purposes. The Company paid a five-digit license fee to Columbia as consideration for entering into the Columbia License Agreement, which was recorded to research and development expenses in the statement of operations for the year ended December 31, 2019. The Company is obligated to use Commercially Reasonable Efforts, as defined in the Columbia License Agreement, to develop and commercialize the TFF2 Product, and to achieve specified developmental milestones. The Company is obligated to pay Columbia single-digit royalties on net sales of (i) TFF2 Products sold by Tonix or a sublicensee and (ii) any other products that involve material or technical information related to the TFF2 Product and transferred to Tonix pursuant to the Columbia License Agreement (“Other Products”) sold by Tonix or a sublicensee. Royalties on each particular TFF2 Product are payable on a country-by-country and Product-by-Product basis until the latest of (i) the date of expiration of the last valid claim in the last to expire of the issued patents covered by the Columbia License Agreement, and (ii) a specified period of time after the first commercial sale of a TFF2 Product in the country in question. Royalties on each particular Other Product are payable on a country-by-country and product-by-product basis until a specified period of time after the first commercial sale of such particular Other Product in such country. Royalties payable on net sales of the TFF2 Product and Other Products may be reduced by 50 50 The Company is also obligated to make contingent milestone payments to Columbia totaling $ 4.1 5 On May 20, 2019, the Company entered into an exclusive License Agreement (the “License Agreement”) with Columbia pursuant to which Columbia, for itself and on behalf of the University of Kentucky and the University of Michigan (collectively, the “Institutions”) granted to the Company an exclusive license, with the right to sublicense, certain patents, technical information and material (collectively, the “Technology”) related to a double-mutant cocaine esterase, and to develop and commercialize products thereunder (each, a “Product”). Pursuant to the terms of the License Agreement, Columbia has reserved for itself and the Institutions the right to practice the Technology for academic research and educational purposes. The Company paid a six-digit license fee to Columbia as consideration for entering into the License Agreement. The Company is obligated to use Commercially Reasonable Efforts, as defined in the License Agreement, to develop and commercialize the Product, and to achieve specified developmental milestones. The Company agreed to pay Columbia single-digit royalties on net sales of (i) Products sold by the Company or a sublicensee and (ii) any other products that involve material or technical information related to the Product and transferred to the Company pursuant to the License Agreement (“Other Products”) sold by the Company or a sublicensee. Royalties on each particular Product are payable on a country-by-country and Product-by-Product basis until the latest of (i) the date of expiration of the last valid claim in the last to expire of the issued patents covered by the License Agreement, (ii) a specified period of time after the first commercial sale of a Product in the country in question, or (iii) expiration of any market exclusivity period granted by a regulatory agency. Royalties on each particular Other Product are payable on a country-by-country and product-by-product basis until the later of (i) a specified period of time after the first commercial sale of such particular Other Product in such country or (ii) expiration of any market exclusivity period granted by a regulatory agency. Royalties payable on net sales of the Product and Other Products may be reduced by 50 50 The Company is also obligated to make contingent milestone payments to Columbia totaling $ 3 5 |
SALE OF COMMON STOCK
SALE OF COMMON STOCK | 12 Months Ended |
Dec. 31, 2022 | |
Sale Of Common Stock | |
SALE OF COMMON STOCK | NOTE 16 – SALE OF COMMON STOCK 2022 Lincoln Park Transaction On August 16, 2022, the Company entered into a purchase agreement (the “2022 Purchase Agreement”) and a registration rights agreement (the “2022 Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Pursuant to the terms of the 2022 Purchase Agreement, Lincoln Park has agreed to purchase from the Company up to $ 50,000,000 Pursuant to the terms of the 2022 Purchase Agreement, at the time the Company signed the 2022 Purchase Agreement and the 2022 Registration Rights Agreement, the Company issued 625,000 1,000,000 During the year ended December 31, 2022, the Company sold 1 0.5 Subsequent to December 31, 2022, the Company sold 0.6 0.4 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 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 90,910 1.6 During the year ended December 31, 2022, the Company sold 2.9 8.7 Under applicable rules of the NASDAQ Global Market, the Company could not issue or sell more than 19.99 2.9 million 2.9 2021 Lincoln Park Transaction On May 14, 2021, the Company entered into a purchase agreement (the “2021 Purchase Agreement”) and a registration rights agreement (the “2021 Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Pursuant to the terms of the 2021 Purchase Agreement, Lincoln Park agreed to purchase from the Company up to $ 80,000,000 Pursuant to the terms of the 2021 Purchase Agreement, at the time the Company signed the 2021 Purchase Agreement and the 2021 Registration Rights Agreement, the Company issued 40,000 1.6 During the year ended December 31, 2021, the Company sold an aggregate of approximately 2 41.3 Under applicable rules of the NASDAQ Global Market, the Company could not issue or sell more than 19.99 2 2 February 2021 Financing On February 8, 2021, the Company entered into a securities purchase agreement with certain institutional investors relating to the issuance and sale of 1.8 38.40 7 4.9 0.1 65 January 2021 Financing On January 11, 2021, the Company entered into a securities purchase agreement with certain institutional investors relating to the issuance and sale of 1.6 25.60 7 2.8 0.3 36.9 At-the-Market Offerings On April 8, 2020, the Company entered into a sales agreement (the “Sales Agreement”) with AGP pursuant to which the Company may issue and sell, from time to time, shares of the Company’s common stock having an aggregate offering price of up to $ 320 3 56.4 85.3 3.5 69.3 2.1 1.4 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | NOTE 17 – STOCK-BASED COMPENSATION Stock Incentive Plans On May 3, 2019, the Company’s stockholders approved the Tonix Pharmaceuticals Holding Corp. 2019 Stock Incentive Plan (the “2019 Plan”). The 2019 Plan provided for the issuance of up to 4,375 18,750 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”), and together with the 2020 Plan and the 2019 Plan, the “Plans”). 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 312,500 20 st 110 100 ten years 627,744 A summary of the stock option activity and related information for the Plans for the years ended December 31, 2022, and 2021 is as follows: Shares Weighted- Average Exercise Price Weighted-Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at December 31, 2020 319,179 $ 2.93 9.26 $ 131,558 Grants 486,639 $ 40.85 — — Exercised — — Forfeitures or expirations (56) 149,713.14 Outstanding at December 31, 2021 805,762 $ 78.02 8.83 $ — Grants 1,695,608 $ 12.06 — $ — Exercised — — Forfeitures or expirations (48,339 ) $ 255.40 Outstanding at December 31, 2022 2,453,031 $ 28.93 8.70 $ — Exercisable at December 31, 2022 590,582 $ 70.82 7.64 $ — The aggregate intrinsic value in the preceding table represents the total pretax intrinsic value, based on options with an exercise price less than the Company’s closing stock price at the respective dates. The weighted average grant date fair value of options granted during the years ended December 31, 2022 and 2021, was $ 5.25 33.78 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 1/36 th ten years one-year one year The assumptions used in the valuation of stock options granted during the year ended December 31, 2022 and 2021 were as follows: 2022 2021 Risk-free interest rate 1.67 3.05 0.79 1.63 Expected term of option 5.5 10 5.5 6 Expected stock price volatility 120.32 133.22 124.37 137.73 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 $ 10.9 7.9 3 7.9 5.5 2.4 As of December 31, 2022, the Company had approximately $ 11.6 1.73 Employee Stock Purchase Plans On May 3, 2019, the Company’s stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2019 Employee Stock Purchase Plan (the “2019 ESPP”). As a result of adoption of the 2020 ESPP, as defined below, by the stockholders, no further grants may be made under the 2019 ESPP Plan. On May 1, 2020, the Company’s stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2020 Employee Stock Purchase Plan (the “2020 ESPP”). No further grants may be made under the 2020 ESPP Plan. On May 6, 2022, the Company’s stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2022 Employee Stock Purchase Plan (the “2022 ESPP”, and together with the 2019 ESPP and the 2020 ESPP, the “ESPP Plans”)). The 2022 ESPP allows eligible employees to purchase up to an aggregate of 93,750 85 9 The 2022 and 2020 ESPP are considered compensatory plans with the related compensation cost expensed over the six-month offering period. For the year ended December 31, 2022 and 2021, $ 46,000 89,000 1,703 28,000 4,000 4,033 40,000 30,000 43,000 93,741 29,000 14,000 |
WARRANTS TO PURCHASE COMMON STO
WARRANTS TO PURCHASE COMMON STOCK | 12 Months Ended |
Dec. 31, 2022 | |
Warrants To Purchase Common Stock | |
WARRANTS TO PURCHASE COMMON STOCK | NOTE 18 – WARRANTS TO PURCHASE COMMON STOCK The following table summarizes information with respect to outstanding warrants to purchase common stock of the Company at December 31, 2022: Exercise Number Expiration Price Outstanding Date $ 16.00 779 November 2024 $ 18.24 3,860 February 2025 $ 1,120.00 15,331 December 2023 19,970 No warrants were exercised during the year ended December 31, 2022. During the year ended December 31, 2021, 107 18.24 2,000 During the year ended December 31, 2021, 5,441 474 630.00 687.50 |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2022 | |
Leases | |
LEASES | NOTE 19 – 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 December 31, 2022, the Company has right-of-use assets of $ 0.7 million 0.7 million 0.3 million 0.4 million At December 31, 2022, 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 $ 441 2024 164 2025 159 2026 9 2027 2 775 Included interest (15 ) $ 760 During the year ended December 31, 2022, the Company entered into new operating leases and lease amendments, resulting in the Company recognizing an additional operating lease liability of approximately $ 386,000 386,000 During the year ended December 31, 2021, the Company entered into lease amendments, resulting in the Company recognizing an operating lease liability of approximately $ 467,000 467,000 Operating lease expense was $ 0.6 Other information related to leases was as follows: Cash paid for amounts included in the measurement of lease liabilities: December 31, 2022 December 31, 2021 Operating cash flow from operating leases (in thousands) $ 598 $ 632 Weighted Average Remaining Lease Term Operating leases 2.20 2.71 Weighted Average Discount Rate Operating leases 2.19 % 1.34 % |
COMMITMENTS
COMMITMENTS | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS | NOTE 20 – COMMITMENTS Contractual agreements The Company has entered into contracts with various contract research organizations with outstanding commitments aggregating approximately $ 58.6 The Company entered into a construction contract with outstanding commitments aggregating approximately $ 2 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 six three 0.9 0.4 |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 21 – INCOME TAXES Components of the net loss consist of the following (in thousands): Year ended December 31, 2022 2021 Foreign $ (88,478 ) $ (73,689 ) Domestic (21,740 ) (18,598 ) Total $ (110,218 ) $ (92,287 ) In 2022, the foreign losses are primarily comprised of $ 86.7 1.5 71.9 A reconciliation of the effect of applying the federal statutory rate to the net loss and the effective income tax rate used to calculate the Company’s income tax provision is as follows: Year Ended December 31, 2022 2021 Statutory federal income tax (21.0 )% (21.0 )% Change in valuation allowance 9.6 % 15.0 % Foreign loss not subject to income tax 7.0 % 7.0 % Attribute reduction from control change 4.0 % (1.2 )% Other 0.4 % 0.2 % Income Tax Provision 0.0 % 0.0 % Deferred tax assets (liabilities) and related valuation allowance as of December 31, 2022 and 2021 were as follows (in thousands): December 31, 2022 2021 Deferred tax assets/(liabilities): Net operating loss carryforward $ 21,642 $ 13,297 Stock-based compensation 7,353 5,832 Other 1,997 2,285 Total deferred assets 30,992 21,414 Valuation allowance (30,992 ) (21,414 ) Net deferred tax assets $ — $ — The Company has incurred research and development (“R&D”) expenses, a portion of which qualifies for tax credits. The Company conducted an R&D credit study to quantify the amount of credits and has claimed an R&D credit on its 2014-2017 tax returns. A portion of these R&D credit carryforwards are subject to annual limitations in their use in accordance with Internal Revenue Service Code (“IRC”) section 383. The R&D credit carryforwards at December 31, 2022 have been reduced to $ 0 At December 31, 2022, the Company has $ 165.5 3.6 80% 2.3 0.3 expire in 20 years Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use the existing deferred tax assets. A significant piece of objective negative evidence evaluated was the cumulative loss incurred over the three-year period ended December 31, 2022. Such objective evidence limits the ability to consider other subjective evidence such as our projections for future growth. As such, the Company has determined that it is not more likely than not that the deferred tax assets will be realized and accordingly, has provided a full valuation allowance against its gross deferred tax assets. The increase in the valuation allowance for the years ended December 31, 2022 and 2021 were $ 9.5 15.3 The Company recognizes interest accrued related to unrecognized tax benefits and penalties as income tax expense. However, as of December 31, 2022 there are no unrecognized tax benefits recorded. The Company is subject to taxation in the United States and various states and foreign jurisdictions. As of December 31, 2022, the Company’s tax returns remain open and subject to examination by the tax authorities for the tax years 2019 and after. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 22 – SUBSEQUENT EVENTS Since January 1, 2023, the Company has repurchased 15,700,269 of its shares of common stock outstanding under its $ 12.5 0.44 1.38 per share for a gross aggregate cost of approximately $ 12.5 In January 2023, the Board of Directors approved 12.5 Since January 1, 2023, the Company has repurchased 1,000,000 of its shares of common stock outstanding under the new share repurchase program at $ 1.14 1.1 The timing and amount of any shares will be determined based on the Company’s evaluation of market conditions and other factors and the may be discontinued or suspended at any time. 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. may be made, in part, under a Rule 10b5-1 plan, which allows stock when the Company might otherwise be precluded from doing so. Subsequent to December 31, 2022, the Company regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market because the Company’s shares had a closing bid price at or above $ 1.00 10 On February 2, 2023, the Company entered into an asset purchase agreement 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. 1.2 1.2 On February 13, 2023, the Company announced that it 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 the Company’s TNX-3600 and TNX-4100 product candidates, respectively. The licensed mAbs were developed as part of a research collaboration and option agreement between the Company and Columbia. On February 23, 2023, the Company granted options to purchase an aggregate of 4,394,303 0.73 ten years 1/3 1/36 th 1,327,500 0.91 ten years 1/3 1/36 th Subsequent to December 31, 2022, the Company sold 2.1 1.4 Subsequent to December 31, 2022, the Company sold 0.6 0.4 |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Reverse Stock Split | Reverse Stock Split On May 16, 2022, the Company filed a Certificate of Change with the Nevada Secretary of State, effective May 17, 2022. Pursuant to the Certificate of Change, the Company effected a 1-for-32 |
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 does not have any commercial products available for sale and has not generated revenues, and there is no assurance that if its products are approved for sale, that the Company will be able to generate cash flow to fund operations. 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. Moreover, the extent to which COVID-19 impacts the Company’s operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence at this time. |
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 the assumptions used in the fair value of stock-based compensation and other equity instruments, and the percent of completion of research and development contracts. |
Cash Equivalents and Restricted 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 December 31, 2022 and December 31, 2021, cash equivalents, which consisted of money market funds, amounted to $ 116.3 120.4 241,000 240,000 The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statement of cash flows: December 31, 2022 December 31, 2021 (in thousands) Cash and cash equivalents $ 120,229 $ 178,660 Restricted cash 241 240 Total $ 120,470 $ 178,900 |
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 30 15 three years five years 1,253,000 50,000 |
Intangible assets with indefinite lives | Intangible assets with indefinite lives 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 Other non-current assets on the 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 December 31, 2022, and 2021, the Company believed that no impairment existed. |
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, lease liability, short term and lease liability, long term in the Company’s 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. |
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. No funding was received during 2022. |
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 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 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 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 December 31, 2022, 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 years ended December 31, 2022 and 2021 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 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 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 for the years ended December 31, 2022 and 2021, as results of operations were a loss for the period. Potentially dilutive securities excluded from the computation of basic and diluted net loss per share, as of December 31, 2022 and 2021, are as follows: 2022 2021 Warrants to purchase common stock 19,970 19,970 Options to purchase common stock 2,453,031 805,762 Totals 2,473,001 825,732 |
Recently Issued Accounting Pronouncements | Recently Issued 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 |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statement of cash flows: | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statement of cash flows: December 31, 2022 December 31, 2021 (in thousands) Cash and cash equivalents $ 120,229 $ 178,660 Restricted cash 241 240 Total $ 120,470 $ 178,900 |
Potentially dilutive securities excluded from the computation of basic and diluted net loss per share, as of December 31, 2022 and 2021, are as follows: | Potentially dilutive securities excluded from the computation of basic and diluted net loss per share, as of December 31, 2022 and 2021, are as follows: 2022 2021 Warrants to purchase common stock 19,970 19,970 Options to purchase common stock 2,453,031 805,762 Totals 2,473,001 825,732 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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): December 31 December 31 2022 2021 (in thousands) Property and equipment, net: Land $ 8,011 $ 7,911 Land improvements 79 — Buildings 65,644 — Office furniture and equipment 1,893 756 Laboratory equipment 18,440 347 Leasehold improvements 34 23 Construction in progress 1,366 41,921 95,467 50,958 Less: Accumulated depreciation and amortization (1,653 ) (400 ) $ 93,814 $ 50,558 |
OTHER BALANCE SHEET INFORMATI_2
OTHER BALANCE SHEET INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Other Balance Sheet Information | |
Components of selected captions in the consolidated balance sheets consist of: | Components of selected captions in the consolidated balance sheets consist of: December 31, 2022 2021 (in thousands) Prepaid expenses and other: Contract-related $ 8,043 $ 7,726 Insurance 1,275 1,482 Other 1,230 1,181 $ 10,548 $ 10,389 Accrued expenses and other current liabilities: Contract-related $ 3,273 $ 2,832 Compensation and compensation-related 3,645 2,868 Construction in progress 2,103 1,572 Professional fees and other 659 673 $ 9,680 $ 7,945 |
TEMPORARY EQUITY (Tables)
TEMPORARY EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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 14.7 1.1 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 5.2 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 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
A summary of the stock option activity and related information for the Plans for the years ended December 31, 2022, and 2021 is as follows: | A summary of the stock option activity and related information for the Plans for the years ended December 31, 2022, and 2021 is as follows: Shares Weighted- Average Exercise Price Weighted-Average Remaining Contractual Term Aggregate Intrinsic Value Outstanding at December 31, 2020 319,179 $ 2.93 9.26 $ 131,558 Grants 486,639 $ 40.85 — — Exercised — — Forfeitures or expirations (56) 149,713.14 Outstanding at December 31, 2021 805,762 $ 78.02 8.83 $ — Grants 1,695,608 $ 12.06 — $ — Exercised — — Forfeitures or expirations (48,339 ) $ 255.40 Outstanding at December 31, 2022 2,453,031 $ 28.93 8.70 $ — Exercisable at December 31, 2022 590,582 $ 70.82 7.64 $ — |
The assumptions used in the valuation of stock options granted during the year ended December 31, 2022 and 2021 were as follows: | The assumptions used in the valuation of stock options granted during the year ended December 31, 2022 and 2021 were as follows: 2022 2021 Risk-free interest rate 1.67 3.05 0.79 1.63 Expected term of option 5.5 10 5.5 6 Expected stock price volatility 120.32 133.22 124.37 137.73 Expected dividend yield 0.0 0.0 |
WARRANTS TO PURCHASE COMMON S_2
WARRANTS TO PURCHASE COMMON STOCK (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Warrants To Purchase Common Stock | |
The following table summarizes information with respect to outstanding warrants to purchase common stock of the Company at December 31, 2022: | The following table summarizes information with respect to outstanding warrants to purchase common stock of the Company at December 31, 2022: Exercise Number Expiration Price Outstanding Date $ 16.00 779 November 2024 $ 18.24 3,860 February 2025 $ 1,120.00 15,331 December 2023 19,970 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases | |
At December 31, 2022, future minimum lease payments for operating leases with non-cancelable terms of more than one year were as follows (in thousands): | At December 31, 2022, 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 $ 441 2024 164 2025 159 2026 9 2027 2 775 Included interest (15 ) $ 760 |
Other information related to leases was as follows: | Other information related to leases was as follows: Cash paid for amounts included in the measurement of lease liabilities: December 31, 2022 December 31, 2021 Operating cash flow from operating leases (in thousands) $ 598 $ 632 Weighted Average Remaining Lease Term Operating leases 2.20 2.71 Weighted Average Discount Rate Operating leases 2.19 % 1.34 % |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Components of the net loss consist of the following (in thousands): | Components of the net loss consist of the following (in thousands): Year ended December 31, 2022 2021 Foreign $ (88,478 ) $ (73,689 ) Domestic (21,740 ) (18,598 ) Total $ (110,218 ) $ (92,287 ) |
A reconciliation of the effect of applying the federal statutory rate to the net loss and the effective income tax rate used to calculate the Company’s income tax provision is as follows: | A reconciliation of the effect of applying the federal statutory rate to the net loss and the effective income tax rate used to calculate the Company’s income tax provision is as follows: Year Ended December 31, 2022 2021 Statutory federal income tax (21.0 )% (21.0 )% Change in valuation allowance 9.6 % 15.0 % Foreign loss not subject to income tax 7.0 % 7.0 % Attribute reduction from control change 4.0 % (1.2 )% Other 0.4 % 0.2 % Income Tax Provision 0.0 % 0.0 % |
Deferred tax assets (liabilities) and related valuation allowance as of December 31, 2022 and 2021 were as follows (in thousands): | Deferred tax assets (liabilities) and related valuation allowance as of December 31, 2022 and 2021 were as follows (in thousands): December 31, 2022 2021 Deferred tax assets/(liabilities): Net operating loss carryforward $ 21,642 $ 13,297 Stock-based compensation 7,353 5,832 Other 1,997 2,285 Total deferred assets 30,992 21,414 Valuation allowance (30,992 ) (21,414 ) Net deferred tax assets $ — $ — |
BUSINESS (Details Narrative)
BUSINESS (Details Narrative) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Working capital | $ 112,600 | |
Accumulated deficit | (470,038) | $ (359,820) |
Cash and cash equivalents | $ 120,229 | $ 178,660 |
The following table provides a
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same amounts shown in the consolidated statement of cash flows: (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 120,229 | $ 178,660 | |
Restricted cash | 241 | 240 | |
Total | $ 120,470 | $ 178,900 | $ 77,308 |
Potentially dilutive securities
Potentially dilutive securities excluded from the computation of basic and diluted net loss per share, as of December 31, 2022 and 2021, are as follows: (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of basic and diluted net loss per share | 2,473,001 | 825,732 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of basic and diluted net loss per share | 19,970 | 19,970 |
Equity Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of basic and diluted net loss per share | 2,453,031 | 805,762 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 12 Months Ended | ||
May 16, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | |||
Reverse stock split | 1-for-32 | ||
Money market funds | $ 116,300,000 | $ 120,400,000 | |
Restricted Cash | 241,000 | 240,000 | |
Depreciation and amortization expense | $ 1,253,000 | $ 50,000 | |
Building [Member] | Minimum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful life of property and equipment | 20 years | ||
Building [Member] | Maximum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful life of property and equipment | 30 years | ||
Land Improvements and Lab Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful life of property and equipment | 15 years | ||
Computer Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful life of property and equipment | 3 years | ||
Furniture and All Other Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful life of property and equipment | 5 years |
Property and equipment, net con
Property and equipment, net consisted of the following (in thousands): (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | $ 95,467 | $ 50,958 |
Less: Accumulated depreciation and amortization | (1,653) | (400) |
Property and equipment, net | 93,814 | 50,558 |
Land [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | 8,011 | 7,911 |
Land Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | 79 | |
Building [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | 65,644 | |
Furniture and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | 1,893 | 756 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | 18,440 | 347 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | 34 | 23 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | $ 1,366 | $ 41,921 |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details Narrative) | 12 Months Ended | 27 Months Ended | |||
Oct. 01, 2021 USD ($) ft² | Dec. 23, 2020 USD ($) a | Sep. 28, 2020 USD ($) ft² | Dec. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Land [Member] | |||||
Property, Plant and Equipment [Line Items] | |||||
Facility purchase | $ 2,100,000 | ||||
MARYLAND | |||||
Property, Plant and Equipment [Line Items] | |||||
Area of facility | ft² | 45,000 | ||||
Facility purchase | $ 17,500,000 | ||||
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 |
Components of selected captions
Components of selected captions in the consolidated balance sheets consist of: (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid expenses and other: | ||
Contract-related | $ 8,043 | $ 7,726 |
Insurance | 1,275 | 1,482 |
Other | 1,230 | 1,181 |
10,548 | 10,389 | |
Accrued expenses and other current liabilities: | ||
Contract-related | 3,273 | 2,832 |
Compensation and compensation-related | 3,645 | 2,868 |
Construction in progress | 2,103 | 1,572 |
Professional fees and other | 659 | 673 |
$ 9,680 | $ 7,945 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details Narrative) - USD ($) $ in Millions | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents - fair value | $ 116.3 | $ 120.4 |
STOCKHOLDERS_ EQUITY (Details N
STOCKHOLDERS’ EQUITY (Details Narrative) - shares | May 16, 2022 | Dec. 31, 2022 | Dec. 13, 2022 | Dec. 11, 2022 | Aug. 05, 2022 | Aug. 03, 2022 | May 14, 2022 | Dec. 31, 2021 |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Stockholders' Equity, Reverse Stock Split | 1-for-32 | |||||||
Common Stock, Shares Authorized | 50,000,000 | 1,000,000,000 | 1,000,000,000 | 150,000,000 | 150,000,000 | 50,000,000 | 800,000,000 | 25,000,000 |
Common Stock [Member] | ||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||
Stockholders' Equity, Reverse Stock Split | 1-for-32 | |||||||
Conversion of Stock, Shares Converted | 599,679,596 | |||||||
Conversion of Stock, Shares Issued | 18,740,141 | |||||||
Stock Issued During Period, Shares, Reverse Stock Splits | 130,462 |
The Series A Preferred Stock an
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 |
TEMPORARY EQUITY (Details Narra
TEMPORARY EQUITY (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||||||
Dec. 13, 2022 | Oct. 26, 2022 | Aug. 05, 2022 | Jun. 24, 2022 | Dec. 31, 2022 | Aug. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 11, 2022 | Aug. 03, 2022 | May 16, 2022 | May 14, 2022 | |
Common stock, authorized | 1,000,000,000 | 150,000,000 | 1,000,000,000 | 1,000,000,000 | 25,000,000 | 150,000,000 | 50,000,000 | 50,000,000 | 800,000,000 | |||
Redemption amount | $ 47,250,000 | |||||||||||
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 | ||||||||||
Temporary equity | $ 14,700,000 | $ 26,250,000 | ||||||||||
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 | ||||||||||
Temporary equity | $ 1,050,000 | $ 5,250,000 | ||||||||||
Redeemable Convertible Preferred Stock [Member] | ||||||||||||
Price per share | $ 9.50 | $ 9.50 | ||||||||||
Percentage of issue discount | 5% | 5% | ||||||||||
Stated value per share | $ 10 | $ 10 | $ 10 | $ 10 | $ 10 | |||||||
Proceeds from Issuance of Convertible Preferred Stock | $ 14,300,000 | $ 28,500,000 | ||||||||||
Preferred Stock, Convertible, Conversion Price | $ 1 | $ 4 | ||||||||||
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% | 105% | 105% | 105% | ||||||||
Escrow Deposit | $ 14,300,000 | $ 28,500,000 | ||||||||||
Escrow Deposit for Original Issue Discount | $ 1,500,000 | $ 3,000,000 | ||||||||||
Redemption amount | $ 15,800,000 | $ 31,500,000 |
ASSET PURCHASE AGREEMENT WITH_3
ASSET PURCHASE AGREEMENT WITH KATANA (Details Narrative) - Asset Purchase Agreement [Member] - Katana Pharmaceuticals, Inc [Member] $ in Millions | Dec. 22, 2020 USD ($) |
Asset Acquisition [Line Items] | |
Consideration paid | $ 0.7 |
Research and development costs | $ 0.7 |
ASSET PURCHASE AGREEMENT WITH_4
ASSET PURCHASE AGREEMENT WITH TRIGEMINA (Details Narrative) | Jun. 11, 2020 USD ($) $ / shares shares |
Asset Purchase Agreement [Member] | Trigemina, Inc.[Member] | |
Asset Acquisition [Line Items] | |
Payment for purchase of assets | $ 824,759 |
Number of shares issued (in shares) | shares | 62,500 |
Common stock value (per share) | $ / shares | $ 21.76 |
Research and development costs | $ 2,400,000 |
Assignment and Assumption Agreement [Member] | |
Asset Acquisition [Line Items] | |
Payment for purchase of assets | $ 250,241 |
ASSET PURCHASE AGREEMENT WITH_5
ASSET PURCHASE AGREEMENT WITH TRIMARAN (Details Narrative) | Aug. 19, 2019 USD ($) |
Asset Purchase Agreement [Member] | TRImaran Pharma Inc [Member] | |
Asset Acquisition [Line Items] | |
Payment for purchase of assets | $ 100,000 |
Liabilities assumed | 68,500 |
Research and development costs | 168,500 |
Contingent milestone payment obligation | 3,400,000 |
WSU License Agreement [Member] | |
Asset Acquisition [Line Items] | |
Reimbursement of patent expenses | 75,000 |
Contingent milestone payment obligation | $ 3,400,000 |
Percentage of royalties payable to any third party for intellectual property rights | 50% |
Maximum percentage reduction of royalties payable | 50% |
LICENSE AGREEMENT WITH CURIA (D
LICENSE AGREEMENT WITH CURIA (Details Narrative) $ in Millions | Dec. 22, 2020 USD ($) |
License Agreement [Member] | Curia [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Payment for purchase of assets | $ 0.4 |
LICENSE AGREEMENT WITH OYAGEN (
LICENSE AGREEMENT WITH OYAGEN (Details Narrative) - License Agreement [Member] - Oya Gen Inc [Member] $ in Millions | Apr. 14, 2021 USD ($) shares |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Number of shares issued (in shares) | shares | 86,010 |
Value of shares issued | $ | $ 3 |
LICENSE AGREEMENT WITH INSERM (
LICENSE AGREEMENT WITH INSERM (Details Narrative) $ in Millions | Feb. 11, 2021 USD ($) |
License Agreement [Member] | Inserm [Member] | Oxytocin-based Therapeutics [Member] | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Sale MIlestones | $ 0.4 |
LICENSE AGREEMENTS WITH COLUM_2
LICENSE AGREEMENTS WITH COLUMBIA UNIVERSITY (Details Narrative) - License Agreement [Member] - Trustees Of Columbia University [Member] - USD ($) $ in Millions | Sep. 16, 2019 | May 20, 2019 |
TFF2 Product [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Percentage of third party royalties payable for reduction in royalties payable | 50% | |
Maximum percentage reduction of royalties payable | 50% | |
Contingent milestone payment obligation | $ 4.1 | |
Percentage of pay for consideration | 5% | |
Product [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Percentage of third party royalties payable for reduction in royalties payable | 50% | |
Maximum percentage reduction of royalties payable | 50% | |
Contingent milestone payment obligation | $ 3 | |
Percentage of pay for consideration | 5% |
SALE OF COMMON STOCK (Details N
SALE OF COMMON STOCK (Details Narrative) - USD ($) | 2 Months Ended | 12 Months Ended | ||||||||
Aug. 16, 2022 | Dec. 03, 2021 | May 14, 2021 | Feb. 09, 2021 | Feb. 08, 2021 | Jan. 11, 2021 | Apr. 08, 2020 | Mar. 13, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Purchase Agreement with Lincoln Park 2022 [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued (in shares) | 1,000,000 | |||||||||
Proceeds from equity offerings | $ 500,000 | |||||||||
Purchase Agreement with Lincoln Park 2022 [Member] | Subsequent Event [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued (in shares) | 600,000 | |||||||||
Proceeds from equity offerings | $ 400,000 | |||||||||
Purchase Agreement with Lincoln Park 2022 [Member] | Lincoln Park Capital Fund, LLC [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Commitment to purchase shares under agreement | $ 50,000,000 | |||||||||
Number of shares issued (in shares) | 625,000 | |||||||||
Number of shares issued, value | $ 1,000,000 | |||||||||
Purchase Agreement With Lincoln Park [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued (in shares) | 2,900,000 | |||||||||
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 | 2,900,000 | |||||||||
Purchase Agreement With Lincoln Park [Member] | Lincoln Park Capital Fund, LLC [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Commitment to purchase shares under agreement | $ 80,000,000 | |||||||||
Number of shares issued (in shares) | 90,910 | |||||||||
Number of shares issued, value | $ 1,600,000 | |||||||||
Purchase Agreement with Lincoln Park 2021 [Member] | Lincoln Park Capital Fund, LLC [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Commitment to purchase shares under agreement | $ 80,000,000 | |||||||||
Number of shares issued (in shares) | 40,000 | |||||||||
Number of shares issued, value | $ 1,600,000 | |||||||||
Purchase Agreement 2021 [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued (in shares) | 2,000,000 | |||||||||
Proceeds from equity offerings | $ 41,300,000 | |||||||||
Percentage of issuance by issuer of common stock | 19.99% | |||||||||
Underwriting Agreement [Member] | Alliance Global Partners [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued (in shares) | 1,800,000 | 1,600,000 | ||||||||
Proceeds from equity offerings | $ 65,000,000 | $ 36,900,000 | ||||||||
Sale of stock, price (in dollars per share) | $ 38.40 | $ 25.60 | ||||||||
Cash fee | 7% | 7% | ||||||||
Underwriting discount | $ 4,900,000 | $ 2,800,000 | ||||||||
Expenses from sale of stock | $ 100,000 | $ 300,000 | ||||||||
Sales Agreement [Member] | Alliance Global Partners [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Offering price per agreement | $ 320,000,000 | |||||||||
Commission to agent | 3% | |||||||||
Sales Agreement [Member] | Alliance Global Partners [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued (in shares) | 56,400,000 | 3,500,000 | ||||||||
Proceeds from equity offerings | $ 85,300,000 | $ 69,300,000 | ||||||||
Sales Agreement [Member] | Alliance Global Partners [Member] | Subsequent Event [Member] | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of shares issued (in shares) | 2,100,000 | |||||||||
Proceeds from equity offerings | $ 1,400,000 |
A summary of the stock option a
A summary of the stock option activity and related information for the Plans for the years ended December 31, 2022, and 2021 is as follows: (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-Based Payment Arrangement [Abstract] | |||
Outstanding at beginning | 805,762 | 319,179 | |
Outstanding at beginning | $ 78.02 | $ 2.93 | |
Weighted average remaining contractual term | 8 years 8 months 12 days | 8 years 9 months 29 days | 9 years 3 months 3 days |
Beginning, Aggregate Intrinsic Value | $ 131,558 | ||
Grants | 1,695,608 | 486,639 | |
Grants | $ 12.06 | $ 40.85 | |
Forfeitures or expirations | (48,339) | (56) | |
Forfeitures or expirations | $ 255.40 | $ 149,713.14 | |
Outstanding at end | 2,453,031 | 805,762 | 319,179 |
Outstanding at end | $ 28.93 | $ 78.02 | $ 2.93 |
Exercisable at end | 590,582 | ||
Exercisable at end | $ 70.82 | ||
Exercisable at end | 7 years 7 months 20 days |
The assumptions used in the val
The assumptions used in the valuation of stock options granted during the year ended December 31, 2022 and 2021 were as follows: (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Risk-free interest rate - Minimum | 1.67% | 0.79% |
Risk-free interest rate - Maximum | 3.05% | 1.63% |
Expected stock price volatility - minimum | 120.32% | 124.37% |
Expected stock price volatility - maximum | 133.22% | 137.73% |
Expected dividend yield | 0% | 0% |
Minimum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected term of option | 5 years 6 months | 5 years 6 months |
Maximum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected term of option | 10 years | 6 years |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||
Feb. 23, 2023 | May 03, 2019 | Jan. 31, 2023 | Jan. 31, 2022 | Jan. 31, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | May 01, 2020 | Jan. 16, 2020 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Weighted average grant date fair value of options (in dollars per share) | $ 5.25 | $ 33.78 | ||||||||||
General and administrative | $ 30,215,000 | $ 23,474,000 | ||||||||||
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 | $ 10,900,000 | 7,900,000 | ||||||||||
General and administrative | 7,900,000 | 5,500,000 | ||||||||||
Research and development costs | 3,000,000 | 2,400,000 | ||||||||||
Unrecognized compensation cost | $ 11,600,000 | |||||||||||
Unrecognized compensation cost, recognition period | 1 year 8 months 23 days | |||||||||||
Share-Based Payment Arrangement, Option [Member] | Subsequent Event [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Expiration period | 10 years | |||||||||||
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 One [Member] | Subsequent Event [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% | |||||||||||
Share-Based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Tranche Two [Member] | Subsequent Event [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Vesting percentage | 2.78% | |||||||||||
2019 Incentive Stock Option Plan [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Number of shares authorized | 4,375 | |||||||||||
2020 Stock Incentive Plan [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Number of shares authorized | 18,750 | |||||||||||
Amended and Restated 2020 Plan [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Number of shares authorized | 312,500 | |||||||||||
Percentage of additional shares authorized | 20% | |||||||||||
Percent of fair value of common stock at grant date | 100% | |||||||||||
Expiration period | 10 years | |||||||||||
Number of shares available for future grants | 627,744 | |||||||||||
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% | |||||||||||
Employee Stock Purchase Plan 2022 [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Number of shares authorized | 93,750 | |||||||||||
Percent of fair value of common stock at grant date | 85% | |||||||||||
Number of shares available for future grants | 9 | |||||||||||
Employee Stock Purchase Plan 2022 [Member] | Subsequent Event [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Employee stock purchase plan (in shares) | 93,741 | |||||||||||
Transfer to additional paid in capital | $ 29,000 | |||||||||||
ESPP withholdings returned to employees | $ 14,000 | |||||||||||
Employee Stock Purchase Plans [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Stock-based compensation expense | $ 46,000 | $ 89,000 | ||||||||||
Accumulated Employee Payroll Deductions | $ 43,000 | |||||||||||
2020 Employee Stock Purchase Plan [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Employee stock purchase plan (in shares) | 4,033 | 1,703 | ||||||||||
Transfer to additional paid in capital | $ 40,000 | $ 28,000 | ||||||||||
ESPP withholdings returned to employees | $ 30,000 | $ 4,000 |
The following table summarizes
The following table summarizes information with respect to outstanding warrants to purchase common stock of the Company at December 31, 2022: (Details) | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Class of Warrant or Right [Line Items] | |
Number Outstanding | 19,970 |
Warrant One [Member] | |
Class of Warrant or Right [Line Items] | |
Exercise price (in dollars per share) | $ / shares | $ 16 |
Number Outstanding | 779 |
Expiration Date | 2024-11 |
Warrant Two [Member] | |
Class of Warrant or Right [Line Items] | |
Exercise price (in dollars per share) | $ / shares | $ 18.24 |
Number Outstanding | 3,860 |
Expiration Date | 2025-02 |
Warrant Three [Member] | |
Class of Warrant or Right [Line Items] | |
Exercise price (in dollars per share) | $ / shares | $ 1,120 |
Number Outstanding | 15,331 |
Expiration Date | 2023-12 |
WARRANTS TO PURCHASE COMMON S_3
WARRANTS TO PURCHASE COMMON STOCK (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Class of Warrant or Right [Line Items] | ||
Proceeds from exercise of warrants | $ 2,000 | |
Warrant [Member] | ||
Class of Warrant or Right [Line Items] | ||
Number of warrants expired | 5,441 | |
Exercise price of warrants expired (in dollars per share) | $ 630 | |
Warrant One [Member] | ||
Class of Warrant or Right [Line Items] | ||
Number of warrants expired | 474 | |
Exercise price of warrants expired (in dollars per share) | $ 687.50 | |
Warrants from Feb 2020 Financing [Member] | ||
Class of Warrant or Right [Line Items] | ||
Number of exercised warrants | 107 | |
Exercise price (in dollars per share) | $ 18.24 | |
Proceeds from exercise of warrants | $ 2,000 |
At December 31, 2022, future mi
At December 31, 2022, future minimum lease payments for operating leases with non-cancelable terms of more than one year were as follows (in thousands): (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Leases | |
2023 | $ 441 |
2024 | 164 |
2025 | 159 |
2026 | 9 |
2027 | 2 |
775 | |
Included interest | (15) |
$ 760 |
Other information related to le
Other information related to leases was as follows: (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Leases | ||
Operating cash flow from operating leases | $ 598 | $ 632 |
Weighted average remaining lease term operating leases | 2 years 2 months 12 days | 2 years 8 months 15 days |
Weighted average discount rate operating leases | 2.19% | 1.34% |
LEASES (Details Narrative)
LEASES (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Other Commitments [Line Items] | ||
Right-of-use assets, net | $ 715,000 | $ 914,000 |
Total lease liability | 760,000 | |
Lease liability, net of current portion | 328,000 | 467,000 |
Lease liability, current | 432,000 | 489,000 |
Operating lease expense | 600,000 | 600,000 |
New Operating Lease [Member] | ||
Other Commitments [Line Items] | ||
Right-of-use assets, net | 386,000 | 467,000 |
Total lease liability | $ 386,000 | $ 467,000 |
COMMITMENTS (Details Narrative)
COMMITMENTS (Details Narrative) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Qualified Defined Contribution Plan [Member] | ||
Other Commitments [Line Items] | ||
Employer matching contribution | 100% | |
Maximum annual contributions per employee | 6% | |
Maximum annual contributions per employer | 3% | |
Administrative expenses | $ 0.9 | $ 0.4 |
Research Organizations [Member] | ||
Other Commitments [Line Items] | ||
Outstanding commitments | 58.6 | |
Construction Contract [Member] | ||
Other Commitments [Line Items] | ||
Outstanding commitments | $ 2 |
Components of the net loss cons
Components of the net loss consist of the following (in thousands): (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Foreign | $ (88,478) | $ (73,689) |
Domestic | (21,740) | (18,598) |
Total | $ (110,218) | $ (92,287) |
A reconciliation of the effect
A reconciliation of the effect of applying the federal statutory rate to the net loss and the effective income tax rate used to calculate the Company’s income tax provision is as follows: (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Statutory federal income tax | (21.00%) | (21.00%) |
Change in valuation allowance | 9.60% | 15% |
Foreign loss not subject to income tax | 7% | 7% |
Attribute reduction from control change | 4% | (1.20%) |
Other | 0.40% | 0.20% |
Income Tax Provision | 0% | 0% |
Deferred tax assets (liabilitie
Deferred tax assets (liabilities) and related valuation allowance as of December 31, 2022 and 2021 were as follows (in thousands): (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets/(liabilities): | ||
Net operating loss carryforward | $ 21,642 | $ 13,297 |
Stock-based compensation | 7,353 | 5,832 |
Other | 1,997 | 2,285 |
Total deferred assets | 30,992 | 21,414 |
Valuation allowance | (30,992) | (21,414) |
Net deferred tax assets |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | ||
Foreign losses | $ 88,478,000 | $ 73,689,000 |
Increase in valuation allowance | 9,500,000 | 15,300,000 |
Research Tax Credit Carryforward [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Credit carryforwards | 0 | |
Foreign Tax Authority [Member] | IRELAND | ||
Operating Loss Carryforwards [Line Items] | ||
Foreign losses | 86,700,000 | |
Operating loss carryforwards | 165,500,000 | |
Foreign Tax Authority [Member] | BERMUDA | ||
Operating Loss Carryforwards [Line Items] | ||
Foreign losses | 1,500,000 | $ 71,900,000 |
Domestic Tax Authority [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 3,600,000 | |
Utilization NOL (percent) | 80% | |
State and Local Jurisdiction [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards expiration | expire in 20 years | |
State and Local Jurisdiction [Member] | NEW JERSEY | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 2,300,000 | |
State and Local Jurisdiction [Member] | MASSACHUSETTS | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 300,000 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - USD ($) | 2 Months Ended | 12 Months Ended | ||||
Feb. 23, 2023 | Feb. 02, 2023 | Jan. 02, 2023 | Mar. 13, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Subsequent Event [Line Items] | ||||||
Number of options granted (in shares) | 1,695,608 | 486,639 | ||||
Exercise price of options granted (in dollars per share) | $ 12.06 | $ 40.85 | ||||
Share-Based Payment Arrangement, Option [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Research and development costs | $ 3,000,000 | $ 2,400,000 | ||||
Options term | 10 years | |||||
Share-Based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Tranche One [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Vesting percentage | 33.33% | |||||
Share-Based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Tranche Two [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Vesting percentage | 2.78% | |||||
Purchase Agreement with Lincoln Park 2022 [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares issued (in shares) | 1,000,000 | |||||
Number of shares issued, value | $ 500,000 | |||||
Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Minimum bid price requirements NASDAQ | $ 1 | |||||
Consecutive business days for minimum bid price | 10 days | |||||
Subsequent Event [Member] | Share-Based Payment Arrangement, Option [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of options granted (in shares) | 4,394,303 | |||||
Exercise price of options granted (in dollars per share) | $ 0.73 | |||||
Options term | 10 years | |||||
Subsequent Event [Member] | Share-Based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Tranche One [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Vesting percentage | 33.33% | |||||
Subsequent Event [Member] | Share-Based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Tranche Two [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Vesting percentage | 2.78% | |||||
Subsequent Event [Member] | Share-based Payment Arrangement, Option [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of options granted (in shares) | 1,327,500 | |||||
Exercise price of options granted (in dollars per share) | $ 0.91 | |||||
Options term | 10 years | |||||
Subsequent Event [Member] | Share-based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Tranche One [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Vesting percentage | 33.33% | |||||
Subsequent Event [Member] | Share-based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Tranche Two [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Vesting percentage | 2.78% | |||||
Subsequent Event [Member] | Asset Purchase Agreement [Member] | Healion Bio Inc. [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Consideration paid | $ 1,200,000 | |||||
Research and development costs | $ 1,200,000 | |||||
Subsequent Event [Member] | Sales Agreement with AGP [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares issued (in shares) | 2,100,000 | |||||
Number of shares issued, value | $ 1,400,000 | |||||
Subsequent Event [Member] | Purchase Agreement with Lincoln Park 2022 [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares issued (in shares) | 600,000 | |||||
Number of shares issued, value | $ 400,000 | |||||
Subsequent Event [Member] | Existing Share Repurchase Program [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares repurchased (in shares) | 15,700,269 | |||||
Repurchase program amount | $ 12,500,000 | |||||
Value of shares repurchased | $ 12,500,000 | |||||
Subsequent Event [Member] | Existing Share Repurchase Program [Member] | Minimum [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Price of shares repurchased (in dollars per share) | $ 0.44 | |||||
Subsequent Event [Member] | Existing Share Repurchase Program [Member] | Maximum [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Price of shares repurchased (in dollars per share) | $ 1.38 | |||||
Subsequent Event [Member] | New Share Repurchase Program [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares repurchased (in shares) | 1,000,000 | |||||
Repurchase program amount | $ 12,500,000 | |||||
Price of shares repurchased (in dollars per share) | $ 1.14 | |||||
Value of shares repurchased | $ 1,100,000 |