ATOSSA THERAPEUTICS, INC.
For the period ended Dec 31, 2024. Filed Mar 25, 2025.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 25, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to Consolidated Financial Statements
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.
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, 2024, the Company recorded a net loss of $25.5 million and used $21.0 million of cash in operating activities. As of December 31, 2024, the Company had $71.1 million in unrestricted cash and cash equivalents and working capital of $69.5 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.
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 (the 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.
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, 2024 and 2023, 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 and a prime money market fund accounts. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced anymaterial losses in such accounts and believes it is not exposed to significant risk. The Company invests its excess cash in a highly rated prime money market fund that management believes protects the Company from risk of default and impairment.
Clinical Trial and Preclinical Study Accruals
The Company makes estimates of its accrued expenses for clinical trial and preclinical study activities as of each balance sheet date in its financial statements based on the facts and circumstances known to the Company at that time. These accruals are based upon estimates of costs incurred and fees that may be associated with services provided by clinical trial investigational sites and Contract Research Organizations (CROs), and for other clinical trial-related activities. Payments under certain contracts with such parties depend on factors such as successful enrollment of patients, site initiation and progression through the various stages of the Company's clinical trials. In accruing for these services, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If possible, the Company obtains information regarding unbilled services directly from these service providers. However, the Company may be required to estimate these services based on other information available to it. If the Company underestimates or overestimates the activities or fees associated with a study or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, the Company's estimated accrued liabilities have approximated actual expense incurred. Subsequent changes in estimates may result in a material change in the Company's accruals.
Prepaid Materials
The Company capitalizes the purchase of certain raw materials, active pharmaceutical ingredients and related supplies for use in the manufacturing of drug products for use in its preclinical and clinical development programs, as it has determined that these materials have alternative future use. The Company can use these raw materials and related supplies in multiple clinical drug products, and therefore has future use independent of the development status of any particular drug program until it is utilized in the manufacturing process. The Company expenses the cost of materials when used. The Company periodically reviews 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.
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 had one investment in non-marketable equity securities. This investment did not have a readily determinable fair value, so the Company elected to measure the investment at cost less any impairment, adjusted to fair value if there were 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 performed an assessment to determine if it qualified for this measurement alternative.
At each reporting period, the Company made a qualitative assessment considering impairment indicators to evaluate whether the investment was impaired. If a qualitative assessment indicated the investment was impaired, the Company estimated the investment's fair value. If the fair value was less than the investment's carrying value, an impairment charge was 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 was established. Refer to Note 4 to these Consolidated Financial Statements.
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, and accounts payable approximate their fair values due to their short-term nature. Refer to Note 9 to these Consolidated Financial Statements.
Research and Development
Research and development (R&D) costs are expensed as incurred and consist of costs associated with research activities. 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.
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, typicallyone tofour years, as the Company does not have sufficient option exercise experience. The dividend yield assumption ofzero 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 Adopted Accounting Pronouncements
For the year ended December 31, 2024, the Company adopted Accounting Standards Update, or ASU, No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This standard requires disclosure of significant segment expensesand other segment items by reportable segment. The adoption of this guidance didnot have a material financial impact on the Company's Consolidated Financial Statements, see Note 16 to these Consolidated Financial Statements.
Recently Issued Accounting Pronouncements
In November 2024, the Financial Accounting Standards Board (FASB) issued ASU No. 2024-03, Disaggregation of Income Statement Expenses (Topic 220-40). This standard requires business entities to disclose in a tabular format, on an annual and interim basis, purchases of inventory, employee compensation, depreciation, intangible asset amortization and depletion for each income statement line item that contains those expenses. The guidance is effective for fiscal years beginning after December 15, 2025, and interim periods within fiscal years beginning after December 15, 2027. Entities may apply the guidance prospectively or retrospectively. The Company is currently assessing the potential impact of this ASU.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes: Improvements to Income Tax Disclosures (Topic 740). This standard enhances disclosures related to income taxes, including the rate reconciliation and information on income taxes paid. This ASU became effective on January 1, 2025. The Company is currently assessing the 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.
NOTE 4: INVESTMENT IN EQUITY SECURITIES
The Company held an investment in Dynamic Cell Therapies, Inc. (DCT), a U.S. private company that was 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 determined that DCT was a VIE however, the Company did not consolidate DCT because it did not have the power to direct economically significant activities. The Company had no obligation to provide any future funding to DCT and its maximum exposure to loss was its investment value, which was recorded in the Consolidated Balance Sheets as an Investment in equity securities.
The Company considered qualitative and quantitative impairment factors in determining if there were indicators of impairment of this investment as of September 30, 2024. Specifically, the Company considered concerns about the investee's ability to continue as a going concern due to negative cash flows from operations and its inability to raise additional funding during the three and nine months ended September 30, 2024. Based on these impairment indicators, the Company performed a quantitative fair value measurement as of September 30, 2024. 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 required the assumptions regarding the expected average volatility of comparable companies, the expected term of the Company's investment, and an estimation of an appropriate risk-free interest rate over the term of the Company's investment. The expected stock price volatility assumption was based upon the average historic volatility of comparable public clinical stage immunotherapy or CAR-T companies. The expected term of the Company's investment was 3.0 years and the risk-free interest rate used was based upon prevailing short term interest rates over the expected term of the investment. The dynamic options approach was weighted at a 5% outcome probability. An adjusted book value approach was also considered and weighted at a 95% probability due to DCT's limited cash on hand, status of current fundraising efforts and the subsequent decision by DCT to lay off all employees and wind down operations. Based on the valuation, the Company concluded that the investment was impaired, and accordingly, an impairment charge of $1.7 million was recorded in the Consolidated Statements of Operations for the year ended December 31, 2024.
On June 30, 2023, the Company considered adverse changes in the general market condition of the industry in which DCT operates and concerns about DCT's ability to continue as a going concern. Based on these impairment indicators, the Company performed a quantitative fair value measurement in the second quarter of 2023. 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 required assumptions regarding the expected average volatility of comparable companies, the expected term of the Company's investment, and an estimation of an appropriate risk-free interest rate over the term of the Company's investment. The expected stock price volatility assumption was based upon the average historic volatility of comparable public clinical stage immunotherapy or CAR-T companies. The expected term of the Company's investment as of June 30, 2023 was 3.5 years and the risk-free interest rate used was 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 then-current fundraising efforts and the estimated timing of a deemed liquidation event occurring as of June 30, 2023. The Company recorded an impairment charge of $3.0 million for the year ended December 31, 2023.
The following table summarizes the changes in the Company's fair value estimate of its Investment in equity securities (in thousands):
| Balance as of January 1, 2023 of Investment in equity securities | $4,700 | |
|---|---|---|
| Impairment charge on Investment in equity securities | (2,990) | |
| Balance as of December 31, 2023 Investment in equity securities | 1,710 | |
| Impairment charge on Investment in equity securities | (1,710) | |
| Balance as of December 31, 2024 Investment in equity securities | $ | - |
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, | |
|---|---|---|
| 2024 | 2023 | |
| Prepaid pre-clinical and clinical trial deposits | $350 | $805 |
| Prepaid insurance | 628 | 794 |
| Prepaid professional services | 68 | 501 |
| Other | 119 | 62 |
| Total prepaid expenses and other current assets | $1,165 | $2,162 |
NOTE 6: ACCRUED EXPENSES
Accrued expenses consisted of the following (in thousands):
| As of December 31, | As of December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Accrued pre-clinical and clinical trial costs | $700 | $608 |
| Accrued professional services and other | 219 | 365 |
| Total accrued expenses | $919 | $973 |
NOTE 7: PAYROLL LIABILITIES
Payroll liabilities consisted of the following (in thousands):
| As of December 31, | As of December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Accrued bonuses | $1,305 | $1,134 |
| Accrued vacation | 226 | 236 |
| Accrued payroll and benefits | 331 | 284 |
| Total payroll liabilities | $1,862 | $1,654 |
NOTE 8: RESEARCH AND DEVELOPMENT TAX REBATE LIABILITY
In 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. 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 not reasonably assured that the full tax position would be sustained under audit. Accordingly, as of December 31, 2024 and 2023, a liability of $1.5 million and $1.8 million, respectively, was included in Other current liabilities in the Consolidated Balance Sheets.
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, 2024 | Estimated Fair Value | Level 1 | Level 2 | Level 3 |
|---|---|---|---|---|
| Assets: | ||||
| Money market fund | $68,543 | $68,543 | $— | $— |
| December 31, 2023 | Estimated Fair Value | Level 1 | Level 2 | Level 3 |
|---|---|---|---|---|
| Assets: | ||||
| Money market fund | $88,029 | $88,029 | $— | $— |
NOTE 10: STOCKHOLDERS’ EQUITY
Common Stock
On June 27, 2024, the Company's stockholders approved an amendment of the Company's Amended and Restated Certificate of Incorporation to increase the number of authorized shares of the Company's common stock, par value $0.18 per share, from 175,000,000 to 350,000,000. As of December 31, 2024, the Company was authorized to issue 350,000,000 shares of common stock, par value $0.18 per share.
Share Repurchases
On June 27, 2023, the Board of Directors (the Board) authorized a program to repurchase the Company's 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. No shares were repurchased during the year ended December 31, 2024 and the program expired on December 31, 2024.
Preferred Stock
The Company is authorized to issue a total of 10,000,000 shares of preferred stock, par value $0.001 per share. 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, 2024 and 2023.
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 the Company's common stock outstanding immediately after giving effect to its conversion.
During the years ended December 31, 2024 and 2023, 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 purchaseone 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 entitle 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, 2024, the following warrants to purchase shares of the Company's common stock were outstanding:
| OutstandingWarrants toPurchase Shares | Exercise Price Per Warrant | Expiration Date | |
|---|---|---|---|
| December 2020 warrants | 2,812,500 | $1.00 | 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 |
Warrant Activity
During the year ended December 31, 2024, the Company received $3.7 million from the exercises of warrants resulting in the issuance of 3,672,500 shares of common stock. There wereno warrant exercises during the year ended December 31, 2023.
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, | ||
|---|---|---|
| 2024 | 2023 | |
| Options to purchase common stock | 18,787,743 | 17,547,573 |
| Series B convertible preferred stock | 165,338 | 165,338 |
| Warrants to purchase common stock | 21,081,655 | 21,514,500 |
| 40,034,736 | 39,227,411 | |
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, | ||
|---|---|---|
| 2024 | 2023 | |
| Expected federal income tax benefit at statutory rate | $(5,356) | $(6,320) |
| Disallowed R&D expenses | 3 | 9 |
| Non-taxable R&D rebate | — | (7) |
| Other permanent items | 235 | 738 |
| Return to provision | 57 | 47 |
| Stock-based compensation | 246 | 682 |
| Foreign rate differential | (76) | (453) |
| Other | 21 | (2) |
| Effect of change in valuation allowance | 4,870 | 5,306 |
| 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, | ||
|---|---|---|
| 2024 | 2023 | |
| Deferred tax assets | ||
| Accrued bonus | $274 | $238 |
| Accrued vacation | 47 | 50 |
| Stock-based compensation | 4,265 | 4,203 |
| Capitalized R&D expenses | 7,825 | 5,788 |
| Rebate reserve | 220 | 303 |
| Intangible assets, net | 181 | 248 |
| Investment in equity securities | 987 | 628 |
| Net operating loss carryforwards | 15,716 | 13,276 |
| Other | 48 | 6 |
| Total gross deferred tax asset | 29,563 | 24,740 |
| Valuation allowance | (29,516) | (24,646) |
| Net deferred tax assets | 47 | 94 |
| Deferred tax liabilities | ||
| Section 481(a) adjustment - bonus compensation | (47) | (94) |
| Net deferred tax assets | $— | $— |
As of December 31, 2024 and 2023, 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, 2024 and 2023. The total valuation allowance increased by $4.9 million for the year ended December 31, 2024 as a result of an increase in net operating loss carryforwards.
The Company has incurred net operating losses since inception. At December 31, 2024, the Company had domestic federal net operating loss carryforwards of $118.4 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, 2024.
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, 2024, the gross net operating loss carryforward is limited to $72.5 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 2018 and beyond for the U.S. operations and 2020 and beyond for Australia operations.
The Company hasno unrecognized tax positions as of December 31, 2024 or 2023 and does not believe there will be any material changes in its unrecognized tax positions over the next 12 months. The Company hasnot incurred any interest or penalties related to unrecognized tax positions for the years ended December 31, 2024 or 2023.
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 Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office, the (PGR Petition), seeking to invalidate all claims related to 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 matter is captioned Intas Pharmaceuticals Ltd. v. Atossa Therapeutics, Inc., PGR 2023-00043.
On January 29, 2025, the PTAB issued a Final Written Decision (the PTAB Decision) finding all challenged claims under the Patent unpatentable. While the Company disagrees with the decision and believes there are appealable issues, the Company will not be pursuing an appeal from the PTAB decision, given the cost and time involved. As of December 31, 2024, there was no material impact to the consolidated financial statements related to this decision.
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 one 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, 2024, the Company's estimated non-cancellable commitment was $10.2 million.
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. 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. On June 27, 2024, the stockholders of the Company approved an amendment and restatement of the 2020 Plan which increased the shares available for issuance by 12,000,000 shares, to a total of 30,000,000 shares available for grant. The 2020 Plan was also extended through June 27, 2034. As of December 31, 2024,12,991,925 shares were available for future grants under the 2020 Plan.
The Company granted 4,701,334 and 6,828,600 options to purchase shares of common stock to employees and directors during the years ended December 31, 2024 and 2023, respectively. The weighted average grant date fair value of options granted during the years ended December 31, 2024 and 2023 was $0.88 and $0.69, respectively. There were 343,998 options exercised during the year ended December 31, 2024. No options were exercised during the year ended December 31, 2023.
The fair values of stock options granted were calculated using the Black-Scholes option-pricing model applying the following assumptions:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Risk-free interest rate | 4.01% - 4.24% | 3.27% - 4.48% |
| Expected term (in years) | 5.31 - 6.11 | 5.31 - 6.16 |
| Dividend yield | — | — |
| Expected volatility | 97% - 120% | 103% - 129% |
The Company recognized stock-based compensation expense in the Consolidated Statements of Operations as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| General and administrative | $1,647 | $3,038 |
| Research and development | 645 | 1,583 |
| Total stock-based compensation expense | $2,292 | $4,621 |
The following table shows a summary of all stock option activity for the year ended December 31, 2024:
| Number ofUnderlyingShares | Weighted-AverageExercise PricePer Share | Weighted-AverageContractualLifeRemainingin Years | AggregateIntrinsic Value | |
|---|---|---|---|---|
| Outstanding as of January 1, 2024 | 17,506,345 | $1.79 | ||
| Granted | 4,701,334 | 1.11 | ||
| Forfeited | (1,167,504) | 1.60 | ||
| Exercised | (343,998) | 0.79 | ||
| Expired | (4,606) | 258.08 | ||
| Outstanding as of December 31, 2024 | 20,691,571 | $1.60 | 6.95 | $657,814 |
| Exercisable as of December 31, 2024 | 16,978,976 | $1.71 | 6.42 | $594,188 |
| Vested and expected to vest | 20,691,571 | $1.60 | 6.95 | $657,814 |
As of December 31, 2024, there were 3,712,595 unvested options outstanding, and the related unrecognized total compensation cost associated with these options was $3.0 million. This expense is expected to be recognized over a weighted-average period of 1.83 years.
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, 2024 and 2023 were $0.3 million and $0.3 million, respectively.
NOTE 16: SEGMENTS
The Company operates as asingle 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 (the CODM) in making decisions regarding resource allocation and in assessing performance. To date, the Company's CODM has made such decisions and assessed performance at the Company-level as a single segment using information at the consolidated financial statement level.
The CODM is Steven C. Quay, M.D., Ph D. Chairman, President and CEO. The CODM utilizes Net Loss from the Consolidated Statement of Operations for the measure of segment profit or loss.
EXHIBIT INDEX
| Incorporated by Reference Herein or Filed or Furnished Herewith | |||
| ExhibitNo. | Description | Form | Date |
| 3.1 | Amended and Restated Certificate of Incorporation | Amendment No. 3 to Registration Statement on Form S-1, as Exhibit 3.2 | June 11, 2012 |
| 3.2 | Certificate of Amendment to Amended and Restated Certificate of Incorporation | Current Report on Form 8-K, as Exhibit 4.1 | August 26, 2016 |
| 3.3 | Certificate of Amendment to Amended and Restated Certificate of Incorporation | Current Report on Form 8-K, as Exhibit 4.1 | April 23, 2018 |
| 3.4 | Certificate of Amendment to Amended and Restated Certificate of Incorporation | Current Report on Form 8-K, as Exhibit 3.1 | January 7, 2020 |
| 3.5 | Certificate of Amendment to Amended and Restated Certificate of Incorporation | Current Report on Form 8-K, as Exhibit 3.1 | July 2, 2024 |
| 3.6 | Amended and Restated Bylaws | Current Report on Form 8-K, as Exhibit 3.2 | April 26, 2023 |
| 3.7 | Certificate of Designation Preferences, and Rights of Series A Junior Participating Preferred Stock | Current Report on Form 8-K, as Exhibit 3.1 | May 22, 2014 |
| 3.8 | Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock | Quarterly Report on Form 10-Q, as Exhibit 3.1 | May 11, 2017 |
| 3.9 | Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock | Current Report on Form 8-K, as Exhibit 3.1 | May 31, 2018 |
| 3.10 | Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock | Current Report on Form 8-K, as Exhibit 3.1 | December 14, 2020 |
| 4.1 | Specimen Common Stock Certificate | Amendment No. 2 to Registration Statement on Form S-1, as Exhibit 4.1 | May 21, 2012 |
| 4.2 | Form of Warrant | Current Report on Form 8-K, as Exhibit 4.1 | January 8, 2021 |
| 4.3 | Form of Warrant | Current Report on Form 8-K, as Exhibit 4.1 | March 23, 2021 |
| 4.4 | Form of Senior Indenture | Registration Statement on Form S-3, as Exhibit 4.1 | September 2, 2020 |
| 4.5 | Form of Senior Indenture | Registration Statement on Form S-3, as Exhibit 4.1 | May 13, 2024 |
| 4.6 | Description of Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934. | Filed herewith | |
| 10.1# | Restated and Amended Employment Agreement with Steven Quay dated September 27, 2010 | Registration Statement on Form S-1, as Exhibit 10.3 | February 14, 2012 |
| 10.3# | 2010 Stock Option and Incentive Plan, as Amended | Current Report on Form 8-K, as Exhibit 4.2 | January 15, 2019 |
| 10.4# | Form of Non-Qualified Stock Option Agreement for Employees | Amendment No. 3 to Registration Statement on Form S-1, as Exhibit 10.8 | June 11, 2012 |
| 10.5# | Form of Non-Qualified Stock Option Agreement for Non-Employee Directors | Amendment No. 3 to Registration Statement on Form S-1, as Exhibit 10.9 | June 11, 2012 |
| 10.6# | Form of Restricted Stock Award Agreement | Amendment No. 3 Registration Statement on Form S-1, as Exhibit 10.13 | June 11, 2012 |
| 10.7# | Form of 2019 Option Award Agreement | Current Report on Form 8-K, as Exhibit 4.1 | January 15, 2019 |
| 10.8# | 2020 Stock Incentive Plan, as Amended | Current Report on Form 8-K, as Exhibit 10.1 | July 2, 2024 |
| 10.9# | Form of ISO Option Award Agreement | Quarterly Report on Form 10-Q, as Exhibit 4.1 | May 13, 2020 |
| 10.10# | Form of Option Award Agreement | Current Report on Form 8-K, as Exhibit 4.1 | April 13, 2020 |
| 10.11# | Employment Agreement with Heather Rees Dated July 1, 2024 | Quarterly Report on Form 10-Q, As Exhibit 10.2 | August 12, 2024 |
| 10.12 | Open Market Sale Agreement SM, dated November 19, 2024, by and between Atossa Therapeutics, Inc. and Jefferies LLC | Current Report onForm 8-K, as Exhibit | November 19, 2024 |
| 19.1 | Insider Trading Policy | Filed herewith |
| 21.1 | List of Subsidiaries | Filed herewith |
| 23.1 | Consent of Ernst & Young, LLP | Filed herewith |
| 31.1 | Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act | Filed herewith |
| 31.2 | Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act | Filed herewith |
| 32.1 (1) | Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act | Furnished herewith |
| 32.2 (1) | Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act | Furnished herewith |
| 101.INS | Inline XBRL Instance Document | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document With Embedded Linkbase Documents | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL and contained in Exhibit 101) |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.