Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Mar. 15, 2024 | Jun. 30, 2023 | |
Document Information [Line Items] | ||||
Entity Central Index Key | 0001488039 | |||
Entity Registrant Name | ATOSSA THERAPEUTICS, INC. | |||
Amendment Flag | false | |||
Current Fiscal Year End Date | --12-31 | |||
Document Fiscal Period Focus | FY | |||
Document Fiscal Year Focus | 2023 | |||
Document Type | 10-K | |||
Document Annual Report | true | |||
Document Period End Date | Dec. 31, 2023 | |||
Document Transition Report | false | |||
Entity File Number | 001-35610 | |||
Entity Incorporation, State or Country Code | DE | |||
Entity Tax Identification Number | 26-4753208 | |||
Entity Address, Address Line One | 107 Spring Street | |||
Entity Address, City or Town | Seattle | |||
Entity Address, State or Province | WA | |||
Entity Address, Postal Zip Code | 98104 | |||
City Area Code | 206 | |||
Local Phone Number | 588-0256 | |||
Title of 12(b) Security | Common Stock, $0.18 par value | |||
Trading Symbol | ATOS | |||
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 | |||
ICFR Auditor Attestation Flag | false | |||
Entity Shell Company | false | |||
Entity Public Float | $ 159,504,497 | |||
Entity Common Stock, Shares Outstanding | 125,304,064 | |||
Auditor Firm ID | 42 | 243 | ||
Auditor Name | EY | BDO USA, LLP | ||
Auditor Location | Seattle, Washington | Seattle, Washington | ||
Document Financial Statement Error Correction [Flag] | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 88,460 | $ 110,890 |
Restricted cash | 110 | 110 |
Prepaid materials | 1,487 | 5,247 |
Prepaid expenses and other current assets | 2,162 | 1,207 |
Research and development tax rebate receivable | 0 | 743 |
Total current assets | 92,219 | 118,197 |
Investment in equity securities | 1,710 | 4,700 |
Other assets | 2,323 | 635 |
Total Assets | 96,252 | 123,532 |
Current liabilities | ||
Accounts payable | 806 | 2,965 |
Accrued expenses | 973 | 1,059 |
Payroll liabilities | 1,654 | 1,525 |
Other current liabilities | 1,803 | 19 |
Total current liabilities | 5,236 | 5,568 |
Total Liabilities | 5,236 | 5,568 |
Commitments and contingencies (Note 13) | ||
Stockholders' equity | ||
Convertible preferred stock - $0.001 par value; 10,000,000 shares authorized; 582 shares issued and outstanding as of December 31, 2023 and 2022 | 0 | 0 |
Common stock - $0.18 par value; 175,000,000 shares authorized; 125,304,064 and 126,624,110 shares issued and outstanding as of December 31, 2023 and 2022, respectively | 22,792 | 22,792 |
Additional paid-in capital | 255,987 | 251,366 |
Treasury stock, at cost; 1,320,046 and 0 shares of common stock at December 31, 2023 and 2022, respectively | (1,475) | 0 |
Accumulated deficit | (186,288) | (156,194) |
Total Stockholders' Equity | 91,016 | 117,964 |
Total Liabilities and Stockholders' Equity | $ 96,252 | $ 123,532 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, issued (in shares) | 582 | 582 |
Preferred stock, outstanding (in shares) | 582 | 582 |
Common stock, par value (in dollars per share) | $ 0.18 | $ 0.18 |
Common stock, authorized (in shares) | 175,000,000 | 175,000,000 |
Common stock, issued (in shares) | 125,304,064 | 126,624,110 |
Common stock, outstanding (in shares) | 125,304,064 | 126,624,110 |
Treasury stock, shares (in shares) | 1,320,046 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating expenses | ||
Research and development | $ 17,334,000 | $ 15,083,000 |
General and administrative | 14,043,000 | 12,608,000 |
Total operating expenses | 31,377,000 | 27,691,000 |
Operating loss | (31,377,000) | (27,691,000) |
Impairment charge on investment in equity securities | (2,990,000) | 0 |
Interest income | 4,343,000 | 877,000 |
Other expense, net | (70,000) | (146,000) |
Loss before income taxes | (30,094,000) | (26,960,000) |
Income taxes benefit | 0 | 0 |
Net loss | $ (30,094,000) | $ (26,960,000) |
Net loss per share of common stock - basic (in dollars per share) | $ (0.24) | $ (0.21) |
Net loss per share of common stock - diluted (in dollars per share) | $ (0.24) | $ (0.21) |
Weighted average shares outstanding used to compute net loss per share- basic (in shares) | 126,081,602 | 126,624,110 |
Weighted average shares outstanding used to compute net loss per share - diluted (in shares) | 126,081,602 | 126,624,110 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Preferred Stock [Member] Convertible Preferred Stock | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Treasury Stock, Common [Member] |
Balance (in shares) at Dec. 31, 2021 | 126,624,110 | 582 | ||||
Balance at Dec. 31, 2021 | $ 138,136 | $ 22,792 | $ 0 | $ 244,578 | $ (129,234) | $ 0 |
Stock-based compensation | 6,788 | 0 | 0 | 6,788 | 0 | 0 |
Net loss | (26,960) | $ 0 | $ 0 | 0 | (26,960) | 0 |
Balance (in shares) at Dec. 31, 2022 | 126,624,110 | 582 | ||||
Balance at Dec. 31, 2022 | 117,964 | $ 22,792 | $ 0 | 251,366 | (156,194) | 0 |
Stock-based compensation | 4,621 | 0 | 0 | 4,621 | 0 | 0 |
Common stock repurchased | (1,475) | $ 0 | 0 | 0 | 0 | (1,475) |
Common stock repurchased, shares | (1,320,046) | |||||
Net loss | (30,094) | $ 0 | $ 0 | 0 | (30,094) | 0 |
Balance (in shares) at Dec. 31, 2023 | 125,304,064 | 582 | ||||
Balance at Dec. 31, 2023 | $ 91,016 | $ 22,792 | $ 0 | $ 255,987 | $ (186,288) | $ (1,475) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (30,094,000) | $ (26,960,000) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Stock-based compensation | 4,621,000 | 6,788,000 |
Impairment charge on investment in equity securities | 2,990,000 | 0 |
Depreciation | 23,000 | 8,000 |
Disposal of assets | 0 | 3,000 |
Changes in operating assets and liabilities: | ||
Prepaid materials | 2,544,000 | (2,953,000) |
Research and development tax rebate receivable | 743,000 | 329,000 |
Prepaid expenses and other current assets | 261,000 | 180,000 |
Other assets | (1,697,000) | (597,000) |
Accounts payable | (2,159,000) | 1,248,000 |
Accrued expenses | (86,000) | 855,000 |
Payroll liabilities | 129,000 | 341,000 |
Other current liabilities | 1,784,000 | (2,000) |
Net cash used in operating activities | (20,941,000) | (20,760,000) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchase of investment in equity securities | 0 | (4,700,000) |
Purchase of property and equipment | (14,000) | (27,000) |
Net cash used in investing activities | (14,000) | (4,727,000) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Common stock repurchased | (1,475,000) | 0 |
Net cash used in financing activities | (1,475,000) | 0 |
NET DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (22,430,000) | (25,487,000) |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING BALANCE | 111,000,000 | 136,487,000 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, ENDING BALANCE | 88,570,000 | 111,000,000 |
RECONCILIATION OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | ||
Cash and cash equivalents | 88,460,000 | 110,890,000 |
Restricted cash | 110,000 | 110,000 |
Total cash, cash equivalents and restricted cash | $ 88,570,000 | $ 111,000,000 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (30,094) | $ (26,960) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Nature of Operations
Nature of Operations | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations | NOTE 1: NATURE OF OPERATIONS Atossa Therapeutics, Inc. (the Company) was incorporated on April 30, 2009, in the State of Delaware to develop and market medical devices, laboratory tests and therapeutics to address breast health conditions. The Company is focused on developing proprietary innovative medicines in areas of significant unmet medical need in oncology, with a focus on breast cancer and other breast conditions. |
Liquidity and Capital Resources
Liquidity and Capital Resources | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Liquidity and Capital Resources | NOTE 2: LIQUIDITY AND CAPITAL RESOURCES The Company has incurred net losses and negative operating cash flows since inception. For the year ended December 31, 2023, the Company recorded a net loss of $ 30.1 million and used $ 20.9 million of cash in operating activities. As of December 31, 2023, the Company had $ 88.5 million in unrestricted cash and cash equivalents and working capital of $ 87.0 million. The Company has not yet established an ongoing source of revenue sufficient to cover its operating costs, and it believes it will need to continue to raise substantial additional capital to accomplish its business plan over the next several years. Management believes its currently available cash and cash equivalents will be sufficient to finance the Company’s operations for at least one year from the date these Consolidated Financial Statements are issued. The Company plans to continue to fund its losses from operations and capital funding needs through a combination of public or private equity offerings, debt financings or other sources, including potential corporate collaborations, licenses and other similar arrangements. There can be no assurance as to the availability or terms upon which such financing and capital might be available in the future. If the Company is unable to secure additional funding, it may be forced to curtail or suspend its business plans. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | NOTE 3: SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation These Consolidated Financial Statements have been prepared pursuant to the rules of the Securities and Exchange Commission (SEC) and in accordance with the accounting principles generally accepted in the U.S. (GAAP). The accompanying Consolidated Financial Statements include the financial statements of Atossa Therapeutics, Inc. and its wholly-owned subsidiaries. All significant intercompany transactions and balances have been eliminated in consolidation. Reclassification Certain reclassifications have been made to prior period financial information to conform to the current year presentation. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these financial statements include the valuation of the investment in non-marketable equity securities, stock-based compensation expense, and prepaid or accrued clinical trial balances at the end of any reporting period. Actual results could differ materially from the Company’s estimates. Segments The Company operates as a single segment. Operating segments are identified as the components of an enterprise of which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and in assessing performance. To date, the Company's chief operating decision maker has made such decisions and assessed performance at the Company-level as a single segment. Cash and Cash Equivalents Cash and cash equivalents include unrestricted cash and all highly liquid instruments with original maturities of three months or less at the date of purchase. Cash equivalents consist primarily of amounts invested in money market accounts. Restricted Cash The Company’s restricted cash balance as of December 31, 2023 and 2022, consisted entirely of cash pledged as security for the Company’s issued commercial credit cards. Concentration of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of deposits of cash and cash equivalents, including those deposited in money market deposit accounts. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any material losses in such accounts and believes it is not exposed to significant risk. The Company has invested its excess cash primarily in money market funds. Prepaid Materials We capitalize the purchase of certain raw materials, active pharmaceutical ingredient and related supplies for use in the manufacturing of drug products for use in our preclinical and clinical development programs, as we have determined that these materials have alternative future use. We can use these raw materials and related supplies in multiple clinical drug products, and therefore have future use independent of the development status of any particular drug program until it is utilized in the manufacturing process. We expense the cost of materials when used. We periodically review these capitalized materials for continued alternative future use and write down the asset to its net realizable value in the period in which an impairment is identified. Prepaid materials not expected to be used within 12 months of the balance sheet date are presented in Other assets on the Consolidated Balance Sheets. Research and Development Tax Rebate Receivable The Company uses the grant accounting model by analogy to International Accounting Standards (IAS) 20 Accounting for Government Grants and Disclosure of Government Assistance to account for the cash rebates received from the Australian government. The Company records the research and development rebate credit in the period when it incurs the associated research and development costs as a reduction to the research and development expenses in the Consolidated Statements of Operations. Variable Interest Entities The Company reviews agreements it enters into with third-party entities, pursuant to which the Company may have a variable interest in the entity, in order to determine if the entity is a variable interest entity (VIE). If the entity is a VIE, the Company assesses whether or not it is the primary beneficiary of that entity. In determining whether the Company is the primary beneficiary of an entity, the Company applies a qualitative approach that determines whether it has both (i) the power to direct the economically significant activities of the entity and (ii) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. If the Company determines it is the primary beneficiary of a VIE, it consolidates that VIE into the Company’s consolidated financial statements. The Company’s determination about whether it should consolidate such VIEs is made continuously as changes to existing relationships or future transactions may result in a consolidation or deconsolidation event. The Company currently does not consolidate any VIEs. Investments in Equity Securities The Company has one investment in non-marketable equity securities. This investment does not have a readily determinable fair value, so the Company has elected to measure the investment at cost less any impairment, adjusted to fair value if there are observable price changes in orderly transactions for an identical or similar investment of the same issuer, in accordance with Accounting Standards Codification (ASC) 321, Investments – Equity Securities . At each reporting period, the Company performs an assessment to determine if it still qualifies for this measurement alternative. At each reporting period, the Company makes a qualitative assessment considering impairment indicators to evaluate whether the investment is impaired. If a qualitative assessment indicates the investment is impaired, the Company estimates the investment's fair value. If the fair value is less than the investment's carrying value, an impairment charge is recorded in the Consolidated Statements of Operations equal to the difference between the carrying value and fair value and a new basis in the investment is established. Refer to Note 4. Other Assets Other assets consist of property and equipment, prepaid materials and clinical deposits. Fair Value Measurements The Company has certain financial assets and liabilities recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements. The fair value hierarchy is broken down into the three input levels summarized below : • Level 1: Quoted market prices in active markets for identical assets or liabilities; • Level 2: Other observable market-based inputs or unobservable inputs that are corroborated by market data; and • Level 3: Unobservable inputs that cannot be corroborated by market data that reflects the reporting entity's own assumptions. The carrying amounts reflected in the accompanying Consolidated Balance Sheets for cash and cash equivalents, restricted cash, research and development tax rebate receivable, and accounts payable approximate their fair values due to their short-term nature. Refer to Note 9. Research and Development Research and development (R&D) costs are generally expensed as incurred. R&D expenses include, for example, manufacturing expenses for the Company's drugs under development, expenses associated with preclinical studies, clinical trials and associated salaries, bonuses, stock-based compensation and benefits. The Company has entered into various research and development contracts with research institutions, clinical research organizations (CROs), clinical manufacturing organizations (CMOs) and other third parties. Payments for these activities are based on the terms of the individual agreements, which may differ from the timing of costs incurred. The Company records accruals for estimated costs incurred for ongoing research and development activities as reflected in the consolidated balance sheets as accrued expenses. Payments made in advance of incurring costs are reflected in the Consolidated Balance Sheets as prepaid expenses. When evaluating the adequacy of the accrued expenses and prepaid expenses, the Company analyzes progress of the services, including the phase or completion of events, invoices received and contracted costs. R&D expenses also include an allocation of the CEO's salary and related benefits, including bonus and non-cash stock-based compensation expense, based on an estimate of his total hours spent on R&D activities. The Company's CEO is involved in the development of the Company's drug candidates and oversight of the related clinical trial activities and also acts as the Company's chief medical officer. Stock-based Compensation The Company measures and recognizes compensation expense for all stock-based awards made to employees, officers, non-employee directors, and other key persons providing services to the Company, currently limited to stock options. Stock-based compensation is measured using the estimated grant date fair value and is recognized as an expense over the requisite service period, generally the vesting period. The Company has made a policy election to recognize forfeitures when they occur. The fair value of each stock option grant is estimated using the Black-Scholes option-pricing model, which requires assumptions regarding the expected volatility of the price of the Company's common stock, the expected life of the options, an expectation regarding future dividends on the Company’s common stock, and a risk-free interest rate. The Company’s expected common stock price volatility assumption is based upon the historical volatility of its stock price. The Company has elected the simplified method for the expected life assumption for stock option grants, which averages the contractual term of the options of 10 years with the vesting term, typically one to four years , as the Company does not have sufficient option exercise experience. The dividend yield assumption of zero is based upon the fact that the Company has never paid cash dividends and presently has no intention of paying cash dividends in the future. The risk-free interest rate assumption is based upon prevailing short-term interest rates over the expected life of the options as of the grant date. Income Taxes The Company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to be recovered or settled. Realization of deferred tax assets is dependent upon future taxable income. A valuation allowance is recognized if it is more likely than not that some portion or all of a deferred tax asset will not be realized based on the weight of available evidence, including expected future earnings. The Company recognizes an uncertain tax position in its financial statements when it concludes that a tax position is more likely than not to be sustained upon examination based solely on its technical merits. Only after a tax position passes the first step of recognition will measurement be required. Under the measurement step, the tax benefit is measured as the largest amount of benefit that is more likely than not to be realized upon effective settlement. This is determined on a cumulative probability basis. The full impact of any change in recognition or measurement is reflected in the period in which such change occurs. The Company records any interest or penalties related to income taxes in income tax benefit in the Consolidated Statements of Operations. Recently Issued Accounting Pronouncements In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures . This standard requires disclosure of significant segment expenses and other segment items by reportable segment. This ASU becomes effective for annual periods beginning in 2024 and interim periods in 2025. The Company is assessing the potential impact of this ASU. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This standard enhances disclosures related to income taxes, including the rate reconciliation and information on income taxes paid. This ASU becomes effective on January 1, 2025. The Company is currently assessing the potential impact of this ASU. The Company does not expect adoption of any other recently issued accounting pronouncements to have a material impact on its financial statements. |
Investment in Equity Securities
Investment in Equity Securities | 12 Months Ended |
Dec. 31, 2023 | |
Equity Method Investments and Joint Ventures [Abstract] | |
Investment in Equity Securities | NOTE 4: INVESTMENT IN EQUITY SECURITIES On December 23, 2022, the Company completed its investment in Dynamic Cell Therapies, Inc. (DCT), a U.S. private company that is in the pre-clinical stage of developing novel Chimeric Antigen Receptor (CAR) T-cell therapies based on technology licensed from a leading U.S. cancer treatment and research institution. The Company’s determined that DCT is a variable interest entity. The Company does not consolidate DCT because it does not have the power to direct economically significant activities. The Company has no obligation to provide any future funding to DCT and its maximum exposure to loss is its investment value. In total, the Company paid $ 4.7 million during the year ended December 31, 2022 to DCT in exchange for Series Seed Preferred Shares representing approximately 19 % of the post-investment outstanding shares of DCT as of December 31, 2022. During 2023, the Company considered the additional adverse changes in the general market condition of the industry in which DCT operates and continued concerns about the investee’s ability to continue as a going concern, due to negative cash flows from operations. Based on these impairment indicators, the Company performed a quantitative fair value measurement in the second quarter of 2023. The assumptions and estimates used to estimate the fair value of the investment include the following information from DCT: • Unaudited financial statements; • Projected technological developments of DCT; • Then-current fundraising transactions; • The-current ability of DCT to raise additional financing when needed; • Changes in the economic environment which may have a material impact on the operating results of DCT; and • Timing of a deemed liquidation event occurring. The impairment of the Company's investment in equity securities required the estimation of fair value using unobservable inputs (a Level 3 fair value measurement). The Company used the dynamic options approach, which requires assumptions regarding the expected average volatility of comparable companies, the expected term of the investment, and the risk-free interest rate over the expected term of the investment. The expected stock price volatility assumption is based upon the average historic volatility of comparable public clinical stage immunotherapy or CAR-T companies. The expected term of the Company's investment is 3.5 years and the risk-free interest rate used is based upon prevailing short-term interest rates over the expected term of the investment. The dynamic options approach was weighted at a 50 % outcome probability. An adjusted book value approach was also considered and also weighted at a 50 % probability due to DCT's limited cash on hand, status of current fundraising efforts and the estimated timing of a deemed liquidation event occurring. The Company recorded an impairment charge of $ 3.0 million for the year ended December 31, 2023. No impairment was recorded during the year ended December 31, 2022 as a result of the Company's qualitative impairment analysis. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Prepaid Expenses and Other Current Assets | NOTE 5: PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets consisted of the following (in thousands): As of December 31, As of December 31, 2023 2022 Prepaid clinical trial deposits $ 805 $ 611 Prepaid insurance 794 387 Prepaid professional services 501 130 Other 62 79 Total prepaid expenses and other current assets $ 2,162 $ 1,207 |
Research and Development Tax Re
Research and Development Tax Rebate Receivable | 12 Months Ended |
Dec. 31, 2023 | |
Research and Development [Abstract] | |
Research and Development Tax Rebate Receivable | NOTE 6: RESEARCH AND DEVELOPMENT TAX REBATE RECEIVABLE On May 23, 2017, the Company formed a wholly owned subsidiary in Australia called Atossa Genetics AUS Pty Ltd. The purpose of this subsidiary is to perform R&D activities, including some of the Company's clinical trials. Australia offers R&D cash rebates on qualified R&D activities incurred in the country. During the years ended December 31, 2023 and 2022, the Company collected R&D cash rebates of $ 0.7 million and $ 1.0 million, respectively. The Company did no t recognize any rebates during the year ended December 31, 2023 and recognized rebates of $ 0.7 million for the year ended December 31, 2022. The Australian R&D tax incentive program is a self-assessment program, and as such, the Australian Taxation Office (ATO) has the right to review the Company’s program and related expenditures for a period of four years following the tax return filing date. If a review were to occur, a qualified program and related expenditures could be disqualified by the ATO with interest and penalties. Based on the Company's evaluation of the ATO's taxpayer alert in December 2023, the Company believes that it is no longer reasonably assured that the full tax position would be sustained under audit. Accordingly, a change in estimate was recorded during the three-month period ended December 31, 2023 that represents the Company's estimate of the amount plus penalties that no longer meets the reasonably assured threshold. The Company accrued a liability of $ 1.8 million, which is included in other current liabilities in the Consolidated Balance Sheet for the year ended December 31, 2023. The change in estimate also increased the Company's R&D expenses by $ 1.4 million and G&A expenses by $ 0.4 million, for the year ended December 31, 2023. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | NOTE 7: ACCRUED EXPENSES Accrued expenses consisted of the following (in thousands): As of December 31, As of December 31, 2023 2022 Accrued clinical trial costs $ 608 $ 1,038 Accrued professional services and other 365 21 Total accrued expenses $ 973 $ 1,059 |
Payroll Liabilities
Payroll Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Payroll Liabilities | NOTE 8: PAYROLL LIABILITIES Payroll liabilities consisted of the following (in thousands): As of December 31, As of December 31, 2023 2022 Accrued bonuses $ 1,134 $ 1,060 Accrued vacation 236 224 Accrued payroll and benefits 284 241 Total payroll liabilities $ 1,654 $ 1,525 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | NOTE 9: FAIR VALUE OF FINANCIAL INSTRUMENTS The following tables present the Company’s fair value hierarchy for all its financial assets and liabilities, by major security type, measured at fair value on a recurring basis (in thousands): December 31, 2023 Estimated Fair Value Level 1 Level 2 Level 3 Assets: Money market fund $ 88,029 $ 88,029 $ — $ — December 31, 2022 Estimated Fair Value Level 1 Level 2 Level 3 Assets: Money market fund $ 102,681 $ 102,681 $ — $ — |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | NOTE 10: STOCKHOLDERS’ EQUITY Common Stock The Company is authorized to issue a total of 185,000,000 shares of stock, consisting of 175,000,000 shares of common stock, par value $ 0.18 per share, and 10,000,000 shares of preferred stock, par value $ 0.001 per share. On May 19, 2014, the Company adopted a stockholder rights agreement, pursuant to which all stockholders of record on May 26, 2014 received a non-taxable distribution of one preferred stock purchase right for each share of the Company’s common stock held by such stockholder. Each right is attached to and trades with the associated share of common stock. The rights will become exercisable only if one of the following occurs: (1) a person becomes an “Acquiring Person” by acquiring beneficial ownership of 15 % or more of the Company’s common stock (or, in the case of a person who beneficially owned 15 % or more of the Company’s common stock on the date the stockholder rights agreement was executed, by acquiring beneficial ownership of additional shares representing 2.0 % of the Company’s common stock then outstanding (excluding compensatory arrangements)), or (2) a person commences a tender offer that, if consummated, would result in such person becoming an Acquiring Person. If a person becomes an Acquiring Person, each right will entitle the holder, other than the Acquiring Person and certain related parties, to purchase a number of shares of the Company’s common stock with a market value that equals twice the exercise price of the right. The initial exercise price of each right is $ 15.00 , so each holder (other than the Acquiring Person and certain related parties) exercising a right would be entitled to receive $ 30.00 worth of the Company’s common stock. If the Company is acquired in a merger or similar business combination transaction at any time after a person has become an Acquiring Person, each holder of a right (other than the Acquiring Person and certain related parties) will be entitled to purchase a similar amount of stock of the acquiring entity. Share Repurchases On June 27, 2023, the Board of Directors (the Board) authorized a program to repurchase common stock, par value $ 0.18 per share, up to an aggregate market value of $ 10.0 million. During the year ended December 31, 2023, 1,320,046 shares were repurchased pursuant to the program for a total cost of $ 1.5 million. The share repurchase program was originally set to expire on December 31, 2023, however, on December 18, 2023 the Board authorized an extension through December 31, 2024. The Board may suspend, modify, or terminate the share repurchase program at any time. Series Convertible Preferred Stock The Company has designated 750,000 shares of Series A junior participating preferred stock, par value $ 0.001 per share, 4,000 shares of Series A convertible preferred stock, par value $ 0.001 per share, 25,000 shares of Series B convertible preferred stock, par value $ 0.001 per share, and 20,000 shares of Series C convertible preferred stock, par value $ 0.001 per share, through the filings of certificates of designation with the Delaware Secretary of State. No shares of Series A junior participating preferred stock, Series A convertible preferred stock, or Series C convertible preferred stock, were outstanding as of December 31, 2023 or 2022. Series B Convertible Preferred Stock Conversion. Each share of Series B convertible preferred stock is convertible at the Company's option at any time, or at the option of the holder at any time, into the number of shares of the Company's common stock determined by dividing the $ 1,000 stated value per share of the Series B convertible preferred stock by a conversion price of $ 3.52 per share. In addition, the conversion price per share is subject to adjustment for stock dividends, distributions, subdivisions, combinations, or reclassifications. Subject to limited exceptions, a holder of the Series B convertible preferred stock will not have the right to convert any portion of the Series B convertible preferred stock to the extent that, after giving effect to the conversion, the holder, together with its affiliates, would beneficially own in excess of 9.99 % of the number of shares of our common stock outstanding immediately after giving effect to its conversion. During the years ended December 31, 2023 and 2022, there were no conversions of Series B convertible preferred stock . Fundamental Transactions. In the event the Company effects certain mergers, consolidations, sales of substantially all of its assets, tender or exchange offers, reclassifications, or share exchanges in which its common stock is effectively converted into or exchanged for other securities, cash or property, the Company consummates a business combination in which another person acquires 50 % of the outstanding shares of its common stock, or any person or group becomes the beneficial owner of 50 % of the aggregate ordinary voting power represented by its issued and outstanding common stock, then, upon any subsequent conversion of the Series B convertible preferred stock, the holders of the Series B convertible preferred stock will have the right to receive any shares of the acquiring corporation or other consideration it would have been entitled to receive if it had been a holder of the number of shares of common stock then issuable upon conversion in full of the Series B convertible preferred stock. Dividends. Holders of Series B convertible preferred stock shall be entitled to receive dividends (on an as-if-converted-to-common-stock basis) in the same form as dividends actually paid on shares of the common stock when, as and if such dividends are paid on shares of common stock. The Company's preferred stock contractually entitles the holders of such securities to participate in dividends but do not contractually require the holders of such securities to participate in losses of the Company. Voting Rights. Except as otherwise provided in the certificate of designation or as otherwise required by law, the Series B convertible preferred stock has no voting rights. Liquidation Preference . Upon the Company's liquidation, dissolution or winding-up, whether voluntary or involuntary, holders of Series B convertible preferred stock will be entitled to receive out of the Company's assets, whether capital or surplus, the same amount that a holder of common stock would receive if the Series B convertible preferred stock were fully converted (disregarding for such purpose any conversion limitations under the certificate of designation) to common stock, which amounts shall be paid pari passu with all holders of common stock. Redemption Rights. The Company is not obligated to redeem or repurchase any shares of Series B convertible preferred stock. Shares of Series B convertible preferred stock are not otherwise entitled to any redemption rights, or mandatory sinking fund or analogous provisions. 2021 and 2020 Warrants The warrants were issued to institutional and accredited investors as a part of the financing transactions, which closed on December 11, 2020, December 21, 2020, December 28, 2020, January 8, 2021, and March 23, 2021. The terms and conditions of the warrants are as follows: Exercisability . Each warrant is exercisable at any time and will expire between 4 and 4.5 years from the date of issuance. The warrants are exercisable, at the option of each holder, in whole or in part by delivering to the Company a duly executed exercise notice and payment in full for the number of shares of the Company's common stock purchased upon such exercise, except in the case of a cashless exercise as discussed below. The number of shares of common stock issuable upon exercise of the warrants is subject to adjustment in certain circumstances, including a stock split or, stock dividend on, or a subdivision, combination or recapitalization of the common stock. Upon the merger, consolidation, sale of substantially all of the Company's assets, or other similar transaction, the holders of warrants shall, at the option of the Company, be required to exercise the warrants immediately prior to the closing of the transaction, or such warrants shall automatically expire. Upon such exercise, the holders of warrants shall participate on the same basis as the holders of common stock in connection with the transaction. Cashless Exercise . If at any time there is no effective registration statement registering, or the prospectus contained therein is not available for issuance of, the shares issuable upon exercise of the warrant, the holder may exercise the warrant on a cashless basis. When exercised on a cashless basis, a portion of the warrant is cancelled in payment of the purchase price payable in respect of the number of shares of the Company's common stock purchasable upon such exercise. Exercise Price . Each warrant represents the right to purchase one share of common stock. In addition, the exercise price per share is subject to adjustment for stock dividends, distributions, subdivisions, combinations or reclassifications, and for certain dilutive issuances. Subject to limited exceptions, a holder of warrants will not have the right to exercise any portion of the warrant to the extent that, after giving effect to the exercise, the holder, together with its affiliates, and any other person acting as a group together with the holder or any of its affiliates, would beneficially own in excess of 4.99 % of the number of shares of the Company's common stock outstanding immediately after giving effect to its exercise. The holder, upon notice to the Company, may increase or decrease the beneficial ownership limitation provisions of the warrant, provided that in no event shall the limitation exceed 9.99 % of the number of shares of the Company's common stock outstanding immediately after giving effect to the exercise of the warrant. Transferability . Subject to applicable laws and restrictions, a holder may transfer a warrant upon surrender of the warrant to us with a completed and signed assignment in the form attached to the warrant. The transferring holder will be responsible for any tax liability that may arise as a result of the transfer. Exchange Listing . The Company does not intend to apply to list the warrants on any securities exchange or recognized trading system. Rights as Stockholder . Except as set forth in the warrant, the holder of a warrant, solely in such holder’s capacity as a holder of a warrant, will not be entitled to vote, to receive dividends or to any of the other rights of the Company's stockholders. The Company's warrants contractually entitles the holders of such securities to participate in dividends but do not contractually require the holders of such securities to participate in losses of the Company. Warrants Outstanding As of December 31, 2023, the following warrants to purchase shares of common stock were outstanding: Outstanding Exercise Price Per Warrant Expiration Date December 2020 warrants 6,489,500 $ 1.00 December 11, 2024-June 21, 2025 January 2021 warrants 4,500,000 $ 1.055 July 8, 2025 March 2021 warrants 10,525,000 $ 2.88 September 22, 2025 21,514,500 Warrant Activity There were no warrant exercises during the years ended December 31, 2023 or 2022. On May 30, 2022, all 762,000 of the warrants issued in May 2018 expired, unexercised, with an exercise price of $ 4.05 per share. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | NOTE 11: NET LOSS PER SHARE Basic net loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding. Diluted net loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock that would have been outstanding during the period assuming the issuance of shares of common stock for all potentially dilutive shares of common stock outstanding. Potentially dilutive shares of common stock consist of future exercises of outstanding stock options, convertible preferred stock and common stock warrants. Because the inclusion of potential shares of common stock would be anti-dilutive for all periods presented, they have been excluded from the calculation. The following table sets forth the weighted average number of common shares excluded from the calculation of diluted net loss per share, because including them would be anti-dilutive: Year Ended December 31, 2023 2022 Options to purchase common stock 17,547,573 12,989,635 Series B convertible preferred stock 165,338 165,338 Warrants to purchase common stock 21,514,500 21,825,703 39,227,411 34,980,676 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Tax Disclosure [Text Block] | NOTE 12: INCOME TAXES A reconciliation of the income tax benefit calculated at the federal statutory rate to total income tax provision is as follows (in thousands): Year Ended December 31, 2023 2022 Expected federal income tax benefit $ ( 6,320 ) $ ( 5,662 ) Disallowed R&D expenses 9 351 Non-taxable R&D rebate ( 7 ) ( 156 ) Other permanent items 738 214 Return to provision 47 862 Stock-based compensation 682 213 Foreign rate differential ( 453 ) ( 270 ) Other ( 2 ) 27 Effect of change in valuation allowance 5,306 4,421 Income tax benefit $ — $ — The following table summarizes the significant components of the Company's deferred tax assets and liabilities (in thousands): As of December 31, 2023 2022 Deferred tax assets Accrued bonus $ 238 $ 222 Accrued vacation 50 47 Stock-based compensation 4,203 4,067 Capitalized R&D expenses 5,788 3,155 Rebate reserve 303 — Intangible assets, net 248 315 Investment in equity securities 628 — Net operating loss carryforwards 13,276 11,522 Other 6 — Total gross deferred tax asset 24,740 19,328 Valuation allowance ( 24,646 ) ( 19,327 ) Net deferred tax assets 94 1 Deferred tax liabilities Section 481(a) adjustment - bonus compensation ( 94 ) — Fixed assets — ( 1 ) Net deferred tax assets $ — $ — As of December 31, 2023 and 2022, a valuation allowance was established against the Company's net deferred tax assets due to the uncertainty regarding the realization of such assets and evidenced by the cumulative losses from operations through December 31, 2023 and 2022. The total valuation allowance increased by $ 5.4 million for the year ended December 31, 2023. The Company has incurred net operating losses since inception. At December 31, 2023, the Company had domestic federal net operating loss carryforwards of $ 106.7 million and foreign net operating loss carryforwards of $ 1.6 million. Federal net operating loss carryforwards generated through December 31, 2017 expire at various dates beginning 2029 through 2038 , while Federal net operating loss carryforwards generated during or after 2018 do not expire. Foreign net operating losses do not expire. The future utilization of the Federal net operating loss carryforwards to offset future taxable income, may be subject to an annual limitation as a result of ownership changes that may have occurred previously or may occur in the future. The Tax Reform Act of 1986 (the Act) limits a Company's ability to utilize certain net operating loss carry forwards in the event of a cumulative change in ownership in excess of 50% (by value) defined in the act. The Company has not completed a study to assess whether an ownership change, as defined by the Act, had occurred from the Company's formation through December 31, 2023. In previous years, the Company completed public offerings, which it believes triggered ownership changes under Section 382 of the Act. The Company believes that as of December 31, 2023, the gross net operating loss carryforward is limited to $ 60.9 million, which are available to reduce future taxable income. The Company files income tax returns in the U.S. and Australia. The Company has not been audited for any open taxation years. The Company is subject to federal tax examinations for 2017 and beyond for the U.S. operations and 2019 and beyond for Australia operations. The Company has no unrecognized tax positions as of December 31, 2023 or 2022 and does not believe there will be any material changes in its unrecognized tax positions over the next 12 months. The Company has no t incurred any interest or penalties related to unrecognized tax positions for the years ended December 31, 2023 or 2022. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | NOTE 13: COMMITMENTS AND CONTINGENCIES Litigation and Contingencies On August 18, 2023, Intas Pharmaceuticals LTD. filed a Petition for Post Grant Review (PGR) with the U.S. Patent and Trademark Office (the PGR Petition), seeking to invalidate one of the Company's issued patents (U.S. Patent No. 11,572,334) titled “Methods for Making and Using Endoxifen” (the Patent) on the grounds of anticipation and obviousness. The Company is actively contesting the PGR Petition and believes that the Patent was properly granted and is valid and enforceable. However, there can be no assurance that the Company will prevail in contesting the PGR Petition. The Company is subject to other legal proceedings and claims that arise in the ordinary course of its business. The Company believes that these matters do not have a material effect, individually or in the aggregate, on its financial position, results of operations or cash flows. Contractual Obligations Contractual obligations represent the Company's future cash commitments and liabilities under agreements with third party clinical trial service providers. Apart from contracts with a third party clinical trial service provider, such agreements are cancellable upon written notice by the Company. The non-cancellable contracts expire upon completion of the clinical trial and release of the final report, or the contracts may be terminated by the clinical trial service provider, by the FDA or another governmental agency. As of December 31, 2023, the Company's estimated non-cancellable commitment was $ 6.1 million. |
Stock Based Compensation
Stock Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Payment Arrangement [Text Block] | NOTE 14: STOCK BASED COMPENSATION On May 15, 2020, the stockholders of the Company approved the 2020 Stock Incentive Plan (the 2020 Plan) to provide for the grants of equity-based awards to employees, officers, non-employee directors and other key persons providing services to the Company. No awards may be granted under the 2020 Plan after May 15, 2030. An aggregate of 3,000,000 shares of common stock was initially reserved for issuance in connection with awards granted under the 2020 Plan. On May 14, 2021, the stockholders approved an additional 15,000,000 shares available for issuance under the 2020 Plan. As of December 31, 2023, 4,646,686 shares were available for future grants under the 2020 Plan. The Company granted 6,828,600 and 4,079,667 options to purchase shares of common stock to employees and directors during the years ended December 31, 2023 and 2022, respectively. The weighted average grant date fair value of options granted during 2023 and 2022 was $ 0.69 and $ 0.96 , respectively. No options were exercised during the years ended December 31, 2023 or 2022. The fair values of stock options granted were calculated using the Black-Scholes option-pricing model applying the following assumptions: Year Ended December 31, 2023 2022 Risk-free interest rate 3.27 % - 4.48 % 1.86 % - 3.56 % Expected term (in years) 5.31 - 6.16 5.19 - 6.11 Dividend yield — — Expected volatility 103 % - 129 % 103 % - 128 % The Company recognized stock-based compensation expense in the Consolidated Statements of Operations as follows (in thousands): Year Ended December 31, 2023 2022 General and administrative $ 3,038 $ 4,395 Research and development 1,583 2,393 Total stock-based compensation expense $ 4,621 $ 6,788 The following table shows a summary of all stock option activity for the year ended December 31, 2023: Number of Weighted- Weighted- Aggregate Outstanding as of January 1, 2023 13,906,358 $ 2.35 — Granted 6,828,600 0.82 Forfeited ( 3,223,874 ) 0.92 Exercised — — Expired ( 4,739 ) 836.63 Outstanding as of December 31, 2023 17,506,345 $ 1.79 7.34 $ 554,525 Exercisable as of December 31, 2023 14,568,342 $ 1.97 6.99 $ 233,076 Vested and expected to vest 17,506,345 $ 1.79 7.34 $ 554,525 As of December 31, 2023, there were 2,938,003 unvested options outstanding, and the related unrecognized total compensation cost associated with these options was $ 1.7 million. This expense is expected to be recognized over a weighted-average period of 1.21 years. |
Defined Contribution Plan
Defined Contribution Plan | 12 Months Ended |
Dec. 31, 2023 | |
Defined Contribution Plan [Abstract] | |
Defined Contribution Plan | NOTE 15: DEFINED CONTRIBUTION PLAN The Company has a defined contribution plan to which employees of the Company may defer contributions for income tax purposes. Participants are eligible to receive employer matching contributions up to 6 % of deferrals. Employees may also be eligible for a discretionary match over 6 %. Defined contribution plan employer matching contributions for the years ended December 31, 2023 and 2022 were $ 0.3 million and $ 0.2 million, respectively. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation These Consolidated Financial Statements have been prepared pursuant to the rules of the Securities and Exchange Commission (SEC) and in accordance with the accounting principles generally accepted in the U.S. (GAAP). The accompanying Consolidated Financial Statements include the financial statements of Atossa Therapeutics, Inc. and its wholly-owned subsidiaries. All significant intercompany transactions and balances have been eliminated in consolidation. |
Reclassification | Reclassification Certain reclassifications have been made to prior period financial information to conform to the current year presentation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these financial statements include the valuation of the investment in non-marketable equity securities, stock-based compensation expense, and prepaid or accrued clinical trial balances at the end of any reporting period. Actual results could differ materially from the Company’s estimates. |
Segments | Segments The Company operates as a single segment. Operating segments are identified as the components of an enterprise of which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and in assessing performance. To date, the Company's chief operating decision maker has made such decisions and assessed performance at the Company-level as a single segment. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents include unrestricted cash and all highly liquid instruments with original maturities of three months or less at the date of purchase. Cash equivalents consist primarily of amounts invested in money market accounts. |
Restricted Cash | Restricted Cash The Company’s restricted cash balance as of December 31, 2023 and 2022, consisted entirely of cash pledged as security for the Company’s issued commercial credit cards. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of deposits of cash and cash equivalents, including those deposited in money market deposit accounts. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any material losses in such accounts and believes it is not exposed to significant risk. The Company has invested its excess cash primarily in money market funds. |
Prepaid Materials | Prepaid Materials We capitalize the purchase of certain raw materials, active pharmaceutical ingredient and related supplies for use in the manufacturing of drug products for use in our preclinical and clinical development programs, as we have determined that these materials have alternative future use. We can use these raw materials and related supplies in multiple clinical drug products, and therefore have future use independent of the development status of any particular drug program until it is utilized in the manufacturing process. We expense the cost of materials when used. We periodically review these capitalized materials for continued alternative future use and write down the asset to its net realizable value in the period in which an impairment is identified. Prepaid materials not expected to be used within 12 months of the balance sheet date are presented in Other assets on the Consolidated Balance Sheets. |
Research and Development Tax Rebate Receivable | Research and Development Tax Rebate Receivable The Company uses the grant accounting model by analogy to International Accounting Standards (IAS) 20 Accounting for Government Grants and Disclosure of Government Assistance to account for the cash rebates received from the Australian government. The Company records the research and development rebate credit in the period when it incurs the associated research and development costs as a reduction to the research and development expenses in the Consolidated Statements of Operations. |
Valuation of Other Investments | Entities The Company reviews agreements it enters into with third-party entities, pursuant to which the Company may have a variable interest in the entity, in order to determine if the entity is a variable interest entity (VIE). If the entity is a VIE, the Company assesses whether or not it is the primary beneficiary of that entity. In determining whether the Company is the primary beneficiary of an entity, the Company applies a qualitative approach that determines whether it has both (i) the power to direct the economically significant activities of the entity and (ii) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. If the Company determines it is the primary beneficiary of a VIE, it consolidates that VIE into the Company’s consolidated financial statements. The Company’s determination about whether it should consolidate such VIEs is made continuously as changes to existing relationships or future transactions may result in a consolidation or deconsolidation event. The Company currently does not consolidate any VIEs. |
Investments in Equity Securities | Investments in Equity Securities The Company has one investment in non-marketable equity securities. This investment does not have a readily determinable fair value, so the Company has elected to measure the investment at cost less any impairment, adjusted to fair value if there are observable price changes in orderly transactions for an identical or similar investment of the same issuer, in accordance with Accounting Standards Codification (ASC) 321, Investments – Equity Securities . At each reporting period, the Company performs an assessment to determine if it still qualifies for this measurement alternative. At each reporting period, the Company makes a qualitative assessment considering impairment indicators to evaluate whether the investment is impaired. If a qualitative assessment indicates the investment is impaired, the Company estimates the investment's fair value. If the fair value is less than the investment's carrying value, an impairment charge is recorded in the Consolidated Statements of Operations equal to the difference between the carrying value and fair value and a new basis in the investment is established. Refer to Note 4. |
Other Assets | Other Assets Other assets consist of property and equipment, prepaid materials and clinical deposits. |
Fair Value Measurements | Fair Value Measurements The Company has certain financial assets and liabilities recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements. The fair value hierarchy is broken down into the three input levels summarized below : • Level 1: Quoted market prices in active markets for identical assets or liabilities; • Level 2: Other observable market-based inputs or unobservable inputs that are corroborated by market data; and • Level 3: Unobservable inputs that cannot be corroborated by market data that reflects the reporting entity's own assumptions. The carrying amounts reflected in the accompanying Consolidated Balance Sheets for cash and cash equivalents, restricted cash, research and development tax rebate receivable, and accounts payable approximate their fair values due to their short-term nature. Refer to Note 9. |
Research and Development | Research and Development Research and development (R&D) costs are generally expensed as incurred. R&D expenses include, for example, manufacturing expenses for the Company's drugs under development, expenses associated with preclinical studies, clinical trials and associated salaries, bonuses, stock-based compensation and benefits. The Company has entered into various research and development contracts with research institutions, clinical research organizations (CROs), clinical manufacturing organizations (CMOs) and other third parties. Payments for these activities are based on the terms of the individual agreements, which may differ from the timing of costs incurred. The Company records accruals for estimated costs incurred for ongoing research and development activities as reflected in the consolidated balance sheets as accrued expenses. Payments made in advance of incurring costs are reflected in the Consolidated Balance Sheets as prepaid expenses. When evaluating the adequacy of the accrued expenses and prepaid expenses, the Company analyzes progress of the services, including the phase or completion of events, invoices received and contracted costs. R&D expenses also include an allocation of the CEO's salary and related benefits, including bonus and non-cash stock-based compensation expense, based on an estimate of his total hours spent on R&D activities. The Company's CEO is involved in the development of the Company's drug candidates and oversight of the related clinical trial activities and also acts as the Company's chief medical officer. |
Stock-based Compensation | Stock-based Compensation The Company measures and recognizes compensation expense for all stock-based awards made to employees, officers, non-employee directors, and other key persons providing services to the Company, currently limited to stock options. Stock-based compensation is measured using the estimated grant date fair value and is recognized as an expense over the requisite service period, generally the vesting period. The Company has made a policy election to recognize forfeitures when they occur. The fair value of each stock option grant is estimated using the Black-Scholes option-pricing model, which requires assumptions regarding the expected volatility of the price of the Company's common stock, the expected life of the options, an expectation regarding future dividends on the Company’s common stock, and a risk-free interest rate. The Company’s expected common stock price volatility assumption is based upon the historical volatility of its stock price. The Company has elected the simplified method for the expected life assumption for stock option grants, which averages the contractual term of the options of 10 years with the vesting term, typically one to four years , as the Company does not have sufficient option exercise experience. The dividend yield assumption of zero is based upon the fact that the Company has never paid cash dividends and presently has no intention of paying cash dividends in the future. The risk-free interest rate assumption is based upon prevailing short-term interest rates over the expected life of the options as of the grant date. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to be recovered or settled. Realization of deferred tax assets is dependent upon future taxable income. A valuation allowance is recognized if it is more likely than not that some portion or all of a deferred tax asset will not be realized based on the weight of available evidence, including expected future earnings. The Company recognizes an uncertain tax position in its financial statements when it concludes that a tax position is more likely than not to be sustained upon examination based solely on its technical merits. Only after a tax position passes the first step of recognition will measurement be required. Under the measurement step, the tax benefit is measured as the largest amount of benefit that is more likely than not to be realized upon effective settlement. This is determined on a cumulative probability basis. The full impact of any change in recognition or measurement is reflected in the period in which such change occurs. The Company records any interest or penalties related to income taxes in income tax benefit in the Consolidated Statements of Operations. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures . This standard requires disclosure of significant segment expenses and other segment items by reportable segment. This ASU becomes effective for annual periods beginning in 2024 and interim periods in 2025. The Company is assessing the potential impact of this ASU. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This standard enhances disclosures related to income taxes, including the rate reconciliation and information on income taxes paid. This ASU becomes effective on January 1, 2025. The Company is currently assessing the potential impact of this ASU. The Company does not expect adoption of any other recently issued accounting pronouncements to have a material impact on its financial statements. |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Table Text Block] | Prepaid expenses and other current assets consisted of the following (in thousands): As of December 31, As of December 31, 2023 2022 Prepaid clinical trial deposits $ 805 $ 611 Prepaid insurance 794 387 Prepaid professional services 501 130 Other 62 79 Total prepaid expenses and other current assets $ 2,162 $ 1,207 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses | Accrued expenses consisted of the following (in thousands): As of December 31, As of December 31, 2023 2022 Accrued clinical trial costs $ 608 $ 1,038 Accrued professional services and other 365 21 Total accrued expenses $ 973 $ 1,059 |
Payroll Liabilities (Tables)
Payroll Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Payroll Liabilities | Payroll liabilities consisted of the following (in thousands): As of December 31, As of December 31, 2023 2022 Accrued bonuses $ 1,134 $ 1,060 Accrued vacation 236 224 Accrued payroll and benefits 284 241 Total payroll liabilities $ 1,654 $ 1,525 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Measured on Recurring Basis | The following tables present the Company’s fair value hierarchy for all its financial assets and liabilities, by major security type, measured at fair value on a recurring basis (in thousands): December 31, 2023 Estimated Fair Value Level 1 Level 2 Level 3 Assets: Money market fund $ 88,029 $ 88,029 $ — $ — December 31, 2022 Estimated Fair Value Level 1 Level 2 Level 3 Assets: Money market fund $ 102,681 $ 102,681 $ — $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Schedule of Stockholders' Equity Note, Warrants or Rights | As of December 31, 2023, the following warrants to purchase shares of common stock were outstanding: Outstanding Exercise Price Per Warrant Expiration Date December 2020 warrants 6,489,500 $ 1.00 December 11, 2024-June 21, 2025 January 2021 warrants 4,500,000 $ 1.055 July 8, 2025 March 2021 warrants 10,525,000 $ 2.88 September 22, 2025 21,514,500 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Securities | The following table sets forth the weighted average number of common shares excluded from the calculation of diluted net loss per share, because including them would be anti-dilutive: Year Ended December 31, 2023 2022 Options to purchase common stock 17,547,573 12,989,635 Series B convertible preferred stock 165,338 165,338 Warrants to purchase common stock 21,514,500 21,825,703 39,227,411 34,980,676 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Effective Income Tax Rate Reconciliation | A reconciliation of the income tax benefit calculated at the federal statutory rate to total income tax provision is as follows (in thousands): Year Ended December 31, 2023 2022 Expected federal income tax benefit $ ( 6,320 ) $ ( 5,662 ) Disallowed R&D expenses 9 351 Non-taxable R&D rebate ( 7 ) ( 156 ) Other permanent items 738 214 Return to provision 47 862 Stock-based compensation 682 213 Foreign rate differential ( 453 ) ( 270 ) Other ( 2 ) 27 Effect of change in valuation allowance 5,306 4,421 Income tax benefit $ — $ — |
Schedule of Deferred Tax Assets and Liabilities | The following table summarizes the significant components of the Company's deferred tax assets and liabilities (in thousands): As of December 31, 2023 2022 Deferred tax assets Accrued bonus $ 238 $ 222 Accrued vacation 50 47 Stock-based compensation 4,203 4,067 Capitalized R&D expenses 5,788 3,155 Rebate reserve 303 — Intangible assets, net 248 315 Investment in equity securities 628 — Net operating loss carryforwards 13,276 11,522 Other 6 — Total gross deferred tax asset 24,740 19,328 Valuation allowance ( 24,646 ) ( 19,327 ) Net deferred tax assets 94 1 Deferred tax liabilities Section 481(a) adjustment - bonus compensation ( 94 ) — Fixed assets — ( 1 ) Net deferred tax assets $ — $ — |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Fair Values of Stock Options Granted Using Black-Scholes Option-Pricing Model | The fair values of stock options granted were calculated using the Black-Scholes option-pricing model applying the following assumptions: Year Ended December 31, 2023 2022 Risk-free interest rate 3.27 % - 4.48 % 1.86 % - 3.56 % Expected term (in years) 5.31 - 6.16 5.19 - 6.11 Dividend yield — — Expected volatility 103 % - 129 % 103 % - 128 % |
Schedule of Share-Based Compensation Expense | The Company recognized stock-based compensation expense in the Consolidated Statements of Operations as follows (in thousands): Year Ended December 31, 2023 2022 General and administrative $ 3,038 $ 4,395 Research and development 1,583 2,393 Total stock-based compensation expense $ 4,621 $ 6,788 |
Schedule of Option Activity for Share-Based Payment Arrangement | The following table shows a summary of all stock option activity for the year ended December 31, 2023: Number of Weighted- Weighted- Aggregate Outstanding as of January 1, 2023 13,906,358 $ 2.35 — Granted 6,828,600 0.82 Forfeited ( 3,223,874 ) 0.92 Exercised — — Expired ( 4,739 ) 836.63 Outstanding as of December 31, 2023 17,506,345 $ 1.79 7.34 $ 554,525 Exercisable as of December 31, 2023 14,568,342 $ 1.97 6.99 $ 233,076 Vested and expected to vest 17,506,345 $ 1.79 7.34 $ 554,525 |
Liquidity and Capital Resourc_2
Liquidity and Capital Resources - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Net loss | $ (30,094) | $ (26,960) |
Cash in operating activities | (20,941) | (20,760) |
Cash and cash equivalents | 88,460 | $ 110,890 |
Working capital | $ 87,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2023 Unit | |
Summary of Accounting Policies [Line Items] | |
Number of operating segments | 1 |
Assumption of dividend yield | 0% |
Maximum [Member] | |
Summary of Accounting Policies [Line Items] | |
Contractual term | 10 years |
Vesting term | 4 years |
Minimum [Member] | |
Summary of Accounting Policies [Line Items] | |
Vesting term | 1 year |
Investment in Equity Securiti_2
Investment in Equity Securities - Additional Information (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Schedule of Equity Method Investments [Line Items] | |||
Payments to acquire equity securities without readily determinable fair value | $ 0 | $ 4,700,000 | |
Equity securities without readily determinable fair Value, impairment loss, annual amount | $ 2,990,000 | 0 | |
Measurement Input Probability [Member] | Valuation Dynamic Options Approach [Member] | |||
Schedule of Equity Method Investments [Line Items] | |||
Equity securities without readily determinable fair value, measurement input | 0.50 | ||
Measurement Input Probability [Member] | Valuation, Cost Approach [Member] | |||
Schedule of Equity Method Investments [Line Items] | |||
Equity securities without readily determinable fair value, measurement input | 0.50 | ||
Measurement Input, Expected Term [Member] | |||
Schedule of Equity Method Investments [Line Items] | |||
Equity securities without readily determinable fair value, measurement input | 3.5 | ||
Dynamic Cell Therapies, Inc. [Member] | |||
Schedule of Equity Method Investments [Line Items] | |||
Payments to acquire equity securities without readily determinable fair value | $ 4,700,000 | ||
Variable interest entity, qualitative or quantitative information, ownership percentage | 19% |
Restricted Cash - Additional In
Restricted Cash - Additional Information (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Restricted Cash and Cash Equivalents [Abstract] | ||
Restricted Cash and Cash Equivalents, Total | $ 110 | $ 110 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Prepaid clinical trial deposits | $ 805 | $ 611 |
Prepaid insurance | 794 | 387 |
Professional services | 501 | 130 |
Other | 62 | 79 |
Total prepaid expenses | $ 2,162 | $ 1,207 |
Research and Development Tax _2
Research and Development Tax Rebate Receivable - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Research And Development Tax Rebate Receivable [Line Items] | ||
Research and development expense, total | $ 17,334,000 | $ 15,083,000 |
General and administrative expenses | 14,043,000 | 12,608,000 |
Atossa Genetics AUS Pty Ltd [Member] | ||
Research And Development Tax Rebate Receivable [Line Items] | ||
Research and development expense, total | 1,400,000 | |
General and administrative expenses | 400,000 | |
Research and development cash rebate | 700,000 | 1,000,000 |
Research and development tax rebate collected | 0 | $ 700,000 |
Atossa Genetics AUS Pty Ltd [Member] | Other Current Liabilities [Member] | ||
Research And Development Tax Rebate Receivable [Line Items] | ||
Estimated accrued liability | $ 1,800,000 |
Accrued Expenses - Summary of A
Accrued Expenses - Summary of Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued clinical trial costs | $ 608 | $ 1,038 |
Accrued professional services and other | 365 | 21 |
Total accrued expenses | $ 973 | $ 1,059 |
Payroll Liabilities - Schedule
Payroll Liabilities - Schedule of Payroll Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued bonuses | $ 1,134 | $ 1,060 |
Accrued vacation | 236 | 224 |
Accrued payroll and benefits | 284 | 241 |
Total payroll liabilities | $ 1,654 | $ 1,525 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Additional Information (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |||
Stockholders' Equity Attributable to Parent, Ending Balance | $ 91,016 | $ 117,964 | $ 138,136 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Schedule of Assets and Liabilities Measured on Recurring Basis (Details) - Fair Value, Recurring [Member] - Money Market Funds [Member] - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market account | $ 88,029 | $ 102,681 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market account | 88,029 | 102,681 |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market account | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market account | $ 0 | $ 0 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | 12 Months Ended | ||||
May 30, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Jun. 27, 2023 | May 19, 2014 | |
Stockholders' Equity [Line Items] | |||||
Number of shares authorized to issue | 185,000,000 | ||||
Common stock, shares authorized | 175,000,000 | 175,000,000 | |||
Common stock, par or stated value per share | $ 0.18 | $ 0.18 | |||
Common stock repurchased | $ 1,475,000 | ||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |||
Preferred stock, par or stated value per share | $ 0.001 | $ 0.001 | |||
Preferred stock, shares issued | 582 | 582 | |||
Stockholder rights agreement, number of preferred stock right distributed for each share of common stock | 1 | ||||
Stockholder rights agreement, acquiring person, percentage of ownership | 15% | ||||
Stockholder rights agreement, acquiring person, additional percentage of ownership | 2% | ||||
Stockholder rights agreement, initial exercise price of each right | $ 15 | ||||
Stockholder rights agreement, share price | $ 30 | ||||
Consummate a business combination, percentage of acquired outstanding shares | 50% | ||||
Consummate a business combination, percentage of aggregate ordinary voting power | 50% | ||||
Class of warrant or right, outstanding | 21,514,500 | ||||
Class of warrant or right, exercised during period | 0 | 0 | |||
Share Repurchases [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Common stock, par or stated value per share | $ 0.18 | ||||
Stock repurchase program, authorized amount | $ 10,000,000 | ||||
Common stock repurchased, shares | 1,320,046 | ||||
Common stock repurchased | $ 1,500,000 | ||||
The 2020 Liability Warrants [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Warrants and rights outstanding, term | 4 years | ||||
Warrants Associated with 2020 Offering Consisting of Common Stock and Warrants [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Warrants and rights outstanding, term | 4 years 6 months | ||||
The 2020 Warrants [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Class of warrant or right, number of securities called by each warrant or right | 1 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 1.055 | ||||
Warrants exercisable, ownership percentage of shares allowed | 4.99% | ||||
Common stock, convertible, ownership percentage of shares allowed | 9.99% | ||||
Class of warrant or right, outstanding | 4,500,000 | ||||
The 2018 Warrants [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 1 | ||||
Class of warrant or right, outstanding | 6,489,500 | ||||
Class of warrant or right, warrants expired | 762,000 | ||||
Class of warrant or right, expirations in period, exercise price | $ 4.05 | ||||
Series A Junior Participating Preferred Stock [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Preferred stock, shares authorized | 750,000 | ||||
Preferred stock, par or stated value per share | $ 0.001 | ||||
Preferred stock, shares issued | 0 | 0 | |||
Series A Convertible Preferred Stock [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Preferred stock, shares authorized | 4,000 | ||||
Preferred stock, par or stated value per share | $ 0.001 | ||||
Preferred stock, shares issued | 0 | 0 | |||
Series B Convertible Preferred Stock [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Preferred stock, shares authorized | 25,000 | ||||
Preferred stock, par or stated value per share | $ 0.001 | ||||
Stated value per share | $ 1,000 | ||||
Preferred stock, convertible, conversion price | $ 3.52 | ||||
Series C Convertible Preferred Stock [Member] | |||||
Stockholders' Equity [Line Items] | |||||
Preferred stock, shares authorized | 20,000 | ||||
Preferred stock, par or stated value per share | $ 0.001 | ||||
Preferred stock, shares issued | 0 | 0 | |||
Preferred stock, convertible, ownership percentage of shares allowed | 9.99% |
Stockholders' Equity - Outstand
Stockholders' Equity - Outstanding Warrants (Details) | Dec. 31, 2023 $ / shares shares |
Stockholders' Equity [Line Items] | |
Outstanding Warrants to Purchase Shares | 21,514,500 |
The 2018 Warrants [Member] | |
Stockholders' Equity [Line Items] | |
Outstanding Warrants to Purchase Shares | 6,489,500 |
Exercise Price Per Warrant | $ / shares | $ 1 |
The 2020 Warrants [Member] | |
Stockholders' Equity [Line Items] | |
Outstanding Warrants to Purchase Shares | 4,500,000 |
Exercise Price Per Warrant | $ / shares | $ 1.055 |
The January 2021 Warrants [Member] | |
Stockholders' Equity [Line Items] | |
Outstanding Warrants to Purchase Shares | 10,525,000 |
Exercise Price Per Warrant | $ / shares | $ 2.88 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Antidilutive Securities (Details) - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Number of potential common shares excluded (in shares) | 39,227,411 | 34,980,676 |
Options to Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Number of potential common shares excluded (in shares) | 17,547,573 | 12,989,635 |
Series B Convertible Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Number of potential common shares excluded (in shares) | 165,338 | 165,338 |
Warrants to Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Number of potential common shares excluded (in shares) | 21,514,500 | 21,825,703 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | ||
Income tax expense (benefit), total | $ 0 | $ 0 |
Gross net operating loss carryforwards | 60,900,000 | |
Deferred tax assets, valuation allowance | 24,646,000 | 19,327,000 |
Valuation allowance, deferred tax asset, increase (decrease), amount | 5,400,000 | |
Unrecognized tax benefits, ending balance | 0 | 0 |
Unrecognized tax benefits, income tax penalties and interest accrued, total | 0 | $ 0 |
Domestic Tax Authority [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 106,700,000 | |
Domestic Tax Authority [Member] | Earliest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards, expiration year | 2029 | |
Domestic Tax Authority [Member] | Latest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards, expiration year | 2038 | |
Foreign Tax Authority [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 1,600,000 |
Income Taxes - Effective Income
Income Taxes - Effective Income Tax Rate Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Expected federal income tax benefit | $ (6,320) | $ (5,662) |
Disallowed R&D expenses | 9 | 351 |
Non-taxable R&D rebate | (7) | (156) |
Other permanent items | 738 | 214 |
Return to provision | 47 | 862 |
Stock-based compensation | 682 | 213 |
Foreign rate differential | (453) | (270) |
Other | (2) | 27 |
Effect of change in valuation allowance | 5,306 | 4,421 |
Income tax benefit | $ 0 | $ 0 |
Income Taxes - Components of Ne
Income Taxes - Components of Net Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets | ||
Accrued bonus | $ 238 | $ 222 |
Deferred tax assets, accrued vacation | 50 | 47 |
Stock-based compensation | 4,203 | 4,067 |
Capitalized R&D expenses | 5,788 | 3,155 |
Rebate reserve | 303 | 0 |
Intangible assets, net | 248 | 315 |
Investment in equity securities | 628 | 0 |
Net operating loss carryforwards | 13,276 | 11,522 |
Other | 6 | 0 |
Total gross deferred tax asset | 24,740 | 19,328 |
Valuation allowance | (24,646) | (19,327) |
Net deferred tax assets | 94 | 1 |
Deferred tax liabilities | ||
Section 481(a) adjustment - bonus compensation | (94) | 0 |
Fixed assets | 0 | (1) |
Net deferred tax asset | $ 0 | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Millions | Dec. 31, 2023 USD ($) |
Research and Development Arrangement [Member] | |
Unrecorded Unconditional Purchase Obligation [Line Items] | |
Estimated non-cancellable commitment | $ 6.1 |
Stock Based Compensation - Addi
Stock Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |||
May 14, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Mar. 24, 2020 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares) | 6,828,600 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Nonvested, Number of Shares, Ending Balance (in shares) | 2,938,003 | |||
Employee Stock Option [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Share-Based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount | $ 1.7 | |||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 1 year 2 months 15 days | |||
The 2020 Stock Incentive Plan [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares) | 15,000,000 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares) | 3,000,000 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares) | 6,828,600 | 4,079,667 | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 0.69 | $ 0.96 | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period (in shares) | 0 | 0 | ||
The 2020 Stock Incentive Plan [Member] | Employee Stock Option [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares) | 4,646,686 |
Stock Based Compensation - Sche
Stock Based Compensation - Schedule of Fair Values of Stock Options Granted Using Black-Scholes Option-Pricing Model (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Risk-free interest rate, Minimum | 3.27% | 1.86% |
Risk-free interest rate, Maximum | 4.48% | 3.56% |
Expected volatility, Minimum | 103% | 103% |
Expected volatility, Maximum | 129% | 128% |
Maximum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 1 month 28 days | 6 years 1 month 9 days |
Minimum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected term (in years) | 5 years 3 months 21 days | 5 years 2 months 8 days |
Stock Based Compensation - Sc_2
Stock Based Compensation - Schedule of Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Stock compensation expense | $ 4,621 | $ 6,788 |
General and administrative | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Stock compensation expense | 3,038 | 4,395 |
Research and development | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Stock compensation expense | $ 1,583 | $ 2,393 |
Stock Based Compensation - Sc_3
Stock Based Compensation - Schedule of Option Activity for Share-Based Payment Arrangement (Details) | 12 Months Ended |
Dec. 31, 2023 USD ($) $ / shares shares | |
Share-Based Payment Arrangement [Abstract] | |
Outstanding, shares (in shares) | shares | 13,906,358 |
Outstanding, weighted average exercise price per share (in dollars per share) | $ / shares | $ 2.35 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross | shares | 6,828,600 |
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ / shares | $ 0.82 |
Forfeited (in shares) | shares | (3,223,874) |
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Forfeitures in Period, Weighted Average Exercise Price | $ / shares | $ 0.92 |
Expired (in shares) | shares | (4,739) |
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Expirations in Period, Weighted Average Exercise Price | $ / shares | $ 836.63 |
Outstanding, shares (in shares) | shares | 17,506,345 |
Outstanding, weighted average exercise price per share (in dollars per share) | $ / shares | $ 1.79 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 7 years 4 months 2 days |
Outstanding, aggregate intrinsic value | $ | $ 554,525 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Number | shares | 14,568,342 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Weighted Average Exercise Price | $ / shares | $ 1.97 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 6 years 11 months 26 days |
Exercisable, aggregate intrinsic value | $ | $ 233,076 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number | shares | 17,506,345 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Exercise Price | $ / shares | $ 1.79 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Remaining Contractual Term | 7 years 4 months 2 days |
Vested and expected to vest, aggregate intrinsic value | $ | $ 554,525 |
Defined Contribution Plan - Add
Defined Contribution Plan - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Defined Contribution Plan [Abstract] | ||
Defined contribution plan, employer matching contribution, percent of match | 6% | |
Defined contribution plan, cost | $ 0.3 | $ 0.2 |