AIM ImmunoTech Inc.
For the period ended Dec 31, 2024. Filed Mar 27, 2025.
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FY2024 · Filed Mar 27, 2025
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Notes to Consolidated Financial Statements
(1) **Description of Business and Basis of Presentation **
AIM ImmunoTech Inc. and its subsidiaries (collectively, “AIM”, “Company”, “we” or “us”) are an immuno-pharma company headquartered in Ocala, Florida, focused on the research and development of therapeutics to treat multiple types of cancers, viral diseases and immune-deficiency disorders. We have established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body, and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.
AIM’s flagship products are Ampligen (rintatolimod) and Alferon N Injection (Interferon alfa). Ampligen is a double-stranded RNA (“dsRNA”) molecule being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen has not been approved by the FDA or marketed in the United States but is approved for commercial sale in the Argentine Republic for the treatment of severe Chronic Fatigue Syndrome (“CFS”).
The Company is currently proceeding primarily in four areas:
| ● | Conducting clinical trials to evaluate the efficacy and safety of Ampligen for the treatment of pancreatic cancer. |
| ● | Evaluating Ampligen across multiple cancers as a potential therapy that modifies the tumor microenvironment with the goal of increasing anti-tumor responses to checkpoint inhibitors. |
| ● | Exploring Ampligen’s antiviral activities and potential use as a prophylactic or treatment for existing viruses, new viruses and mutated viruses thereof. |
| ● | Evaluating Ampligen as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”) and fatigue and/or the Post-COVID condition of fatigue. |
| ● | Evaluating Ampligen as a vaccine adjuvant in the combination of Ampligen and AstraZeneca’s FluMist as an intranasal vaccine for influenza, including avian influenza. |
The Company is prioritizing activities in an order related to the stage of development, with those clinical activities such as pancreatic cancer, ME/CFS and Post-COVID conditions having priority over antiviral experimentation. The Company intends that priority clinical work be conducted in trials authorized by the FDA or European Medicines Agency (“EMA”), which trials support a potential future NDA. However, AIM’s antiviral experimentation is designed to accumulate additional preliminary data supporting their hypothesis that Ampligen is a powerful, broad-spectrum prophylaxis and early-onset therapeutic that may confer enhanced immunity and cross-protection. Accordingly, AIM will conduct antiviral programs in those venues most readily available and able to generate valid proof-of-concept data, including foreign venues.
We have recently announced that we have engaged Amarex Clinical Research (“Amarex”), our Clinical Research Organization, with the application and eventual management of a follow-up Investigational New Drug (“IND”) application for the study of a potential avian influenza combination therapy of our Ampligen and AstraZeneca’s FluMist, a nasal spray vaccine that helps prevent seasonal influenza. We are seeking collaborative grants from government and industry to defray the cost of the study. In addition, we recently announced that the Erasmus Medical Center Safety Committee grants approval to proceed with a Phase 2 Study of Ampligen and Imfinzi as a potential combination therapy for late-stage pancreatic cancer.
AIM’s business plan requires one or more Contract Manufacturing Organizations (“CMO”) to produce Ampligen and its Active Pharmaceutical Ingredients (APIs). This includes utilizing Jubilant HollisterStier and Sterling for the manufacture of Ampligen and our Poly I and Poly C12U polynucleotides, respectively.
In the opinion of management, all adjustments necessary for a fair presentation of its consolidated financial statements have been included. Such adjustments consist of normal recurring items. Interim results are not necessarily indicative of results for a full year.
Basis of Preparation and Consolidation
The accompanying consolidated financial statements include the accounts of AIM ImmunoTech and all entities in which a controlling interest is held by the Company. All significant intercompany balances and transactions have been eliminated in consolidation. The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”).
Liquidity and Going Concern
The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. The going concern basis of presentation assumes that the Company will continue in operation one year after the date these financial statements are issued and will be able to realize its assets and discharge its liabilities and commitments in the normal course of business.
Pursuant to the requirements of the Financial Accounting Standards Board’s (the “FASB”) Accounting Standards Codification (“ASC”) Topic 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for one year from the date these financial statements are issued. This evaluation does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented or are not within control of the Company as of the date the financial statements are issued. When substantial doubt about the Company’s ability to continue as a going concern exists, management evaluates whether the mitigating effect of its plans sufficiently alleviates the substantial doubt. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. .
The Company’s principal source of liquidity is its cash and cash equivalents, marketable securities, and proceeds from financing activities to provide the necessary funding to meet our obligations as they become due. The Company has suffered losses from operations and net cash used on operating activities for the year ended December 31, 2024, and has a working capital deficit as of December 31, 2024. Additionally, the Company’s stockholders’ equity was below the minimum requirements for continued listing on the New York Stock Exchange American (“NYSE American”). These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of at least one year from the date of issuance of these consolidated financial statements. Management evaluated the conditions, and the significance of these conditions related to the Company’s ability to meet its obligations. If the Company is unable to implement sufficient mitigation efforts, the Company may be forced to limit its business activities or be unable to continue as a going concern, which would have a material adverse effect on its results of operations and financial condition.
(2) Summary of Significant Accounting Policies
(a)Cash and Cash Equivalents
Cash includes bank deposits maintained at several financial institutions. The Company considers highly liquid instruments with an original maturity of three months or less to be cash equivalents. At various times throughout the year ended December 31, 2024, some accounts held at financial institutions were in excess of the federally insured limit of $250,000. The Company has not experienced any losses on these accounts and believes credit risk to be minimal.
(b)Marketable Securities
The Company’s marketable investments consist solely of mutual funds. We determine realized gains and losses for marketable investments using the specific identification method and measure the fair value of our marketable investments using a market approach where identical or comparable prices are available. If quoted market prices are not available, fair values of investments are determined using prices from a pricing service, pricing models, quoted prices of investments with similar characteristics or discounted cash flow models.
(c)Property and Equipment, net
| (in thousands) December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Furniture, fixture and equipment | $1,466 | $1,448 |
| Less: accumulated depreciation | (1,358) | (1,321) |
| Property and equipment, net | $108 | $127 |
Property and equipment are recorded at cost. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the respective assets, ranging from three toten years. Depreciation expense for the year ended December 31, 2024 and December 31, 2023 was $37,000 and $39,000, respectively.
(d)Patent and Trademark Rights, net
Patents and trademarks are stated at cost (primarily legal fees) and are amortized using the straight-line method over the established useful life of 17 years. The Company reviews its patents and trademark rights periodically to determine whether they have continuing value, or their value has become impaired. Such review includes an analysis of the patent and trademark’s ultimate revenue and profitability potential. Management’s review addresses whether each patent continues to fit into the Company’s strategic business plans.
(e)Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure (“GAAP”) of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the reporting period. Actual results could differ from those estimates, and those differences may be material. Accounts requiring the use of significant estimates include determination of other-than-temporary impairment on securities, valuation of deferred taxes, patent and trademark valuations, stock-based compensation calculations, fair value of warrants, and contingency accruals.
(f)Revenue
The Company accounts for revenue in accordance with Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers (“Topic 606”). Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Revenue from the sale of Ampligen under cost recovery clinical treatment protocols approved by the FDA is recognized when the product is shipped. The Company has no other obligation associated with its products once shipment has been accepted by the customer.
Revenue from the sale Ampligen under the EAP is recognized as the product is distributed and administered to patients involved in the cost recovery program.
(g)Accounting for Income Taxes
Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted.
The Company applies the provisions of FASB ASC 740-10 Uncertainty in Income Taxes. As a result of the implementation, there has been no material change to the Company’s tax positions as they have not paid any corporate income taxes due to operating losses. With the exception of net operating losses generated in New Jersey, all tax benefits will likely not be recognized due to the substantial net operating loss carryforwards which will most likely not be realized prior to expiration. With no tax due for the foreseeable future, the Company has determined that a policy to determine the accounting for interest or penalties related to the payment of tax is not necessary at this time.
(h)Recent Accounting Standards and Pronouncements
The Financial Accounting Standards Board (“FASB”) issues Accounting Standards Updates (“ASUs”) to improve U.S. General Accounting Principles (“U.S. GAAP”). The Company has reviewed the recently issued ASUs and their applicability to its operations.
During the fiscal year ended December 31, 2024, the Company adopted the following ASUs:
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting—Improvements to Reportable Segment Disclosures, which improves segment disclosure requirements, primarily through enhanced disclosure requirements for significant segment expenses. The improved disclosure requirements apply to all public entities that are required to report segment information, including those with only one reportable segment. The Company adopted the guidance in the fiscal year beginning January 1, 2024 and there was no impact on the Company’s reportable segments identified. Refer to additional required disclosures in Note 17.
In March 2024, the FASB issued ASU 2024-01,*Compensation – Stock Compensation.*This update clarifies the scope of share-based compensation guidance in ASC 718 regarding profits interest awards. The adoption of this standard did not have a material impact on the Company’s financial position or results of operations.
In March 2024, the FASB issued ASU 2024-02,*Codification Improvements-Amendments to Remove References to the Concepts Standards.*This update removes outdated references to the FASB’s Conceptual Framework across multiple topics. The adoption of this standard did not impact the Company’s financial statements.
Other recent accounting pronouncements issued by the FASB did not or are not believed by management to have a material impact on the Company’s present or future financial statements.
(i)Stock-Based Compensation
The Company accounts for its stock-based compensation awards in accordance with FASB ASC Topic 718, “Compensation – Stock Compensation”, which requires recognition of compensation expense related to stock-based compensation awards over the period during which an employee is required to provide service for the award. Compensation expense is equal to the fair value of the award at the date of grant, net of estimated forfeitures.
(j)Common Stock Per Share Calculation
Basic and diluted net loss per share is computed using the weighted average number of shares of Common Stock outstanding during the period. Equivalent Common shares, consisting of 20,587,988 and 3,523,949 of stock options and warrants, are excluded from the calculation of diluted net loss per share for the years ended December 31, 2024 and 2023, respectively, since their effect is antidilutive due to the net loss of the Company.
(k)Long-Lived Assets
The Company assesses long-lived assets for impairment when events or changes in circumstances indicate that the carrying value of the assets or the asset grouping may not be recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant decreases in the market price of a long-lived asset or group, a significant adverse change in the extent or manner in which a long-lived asset (asset group) is being used or its physical condition, a significant adverse change in legal factors or in the business climate that could affect the value of a long-lived asset (asset group), including an adverse action or assessment by a regulator, an accumulation of costs significantly in excess of the amount originally expected for the acquisition or construction of a long-lived asset (asset group), a current period operating or cash flow loss combined with a history of operating or cash flow losses or projection or forecast that demonstrates continuing losses associated with the use of a long-lived asset (asset group) or a current expectation that, more likely than not, a long-lived asset (asset group) will be sold or otherwise disposed of significantly before the end of its previously estimated useful life.
When assessing for impairment, the Company measures the recoverability of assets that it will continue to use in its operations by comparing the carrying value of the asset grouping to our estimate of the related total future undiscounted net cash flows. If an asset grouping’s carrying value is not recoverable through the related undiscounted cash flows, the asset grouping is considered to be impaired.
The Company measures the impairment by comparing the difference between the asset grouping’s carrying value and its fair value. Long-lived assets are considered a non-financial asset and are recorded at fair value only if an impairment charge is recognized. Impairments are determined for groups of assets related to the lowest level of identifiable independent cash flows. The Company makes subjective judgments in determining the independent cash flows that can be related to specific asset groupings. In addition, as the Company reviews its manufacturing process and other manufacturing planning decisions, if the useful lives of assets are shorter than the Company had originally estimated, it accelerates the rate of depreciation over the assets’ new, shorter useful lives.
(l)Lease accounting
The Company is a party to leases for office space, lab facilities and other equipment. The Company determines if a contract contains a lease arrangement at the inception of the contract. For leases in which the Company is the lessee, leases are classified as either finance or operating, with classification affecting the pattern of expense recognition. The Company records right of use assets and operating lease liabilities for its operating leases, which are initially recognized at the present value of future lease payments over the lease term. For leases that do not provide an implicit rate, the Company utilizes an estimated incremental borrowing rate based on market observations existing at lease inception to calculate the present value of future payments. The Company amortizes its right of use assets on a straight-line basis over the associated lease term.
The lease term is defined as the non-cancelable period of the lease, plus any options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option. The Company has elected to include both lease and non-lease components in the determination of lease payments. Payments made to a lessor for items such as taxes, insurance, common area maintenance, or other costs commonly referred to as executory costs, are also included in lease payments if they are fixed. The fixed portion of these payments are included in the calculation of the lease liability, while any variable portion is recognized as variable lease expenses as incurred.
The Company has elected not to recognize right of use assets and lease obligations for its short term leases, which are defined as leases with an initial term of 12 months or less. Lease payments for short term leases are recognized on a straight-line basis over the lease term.
(m)Segment Reporting
The Company manages the business activities on a consolidated basis and operates in one reportable segment, which is the research and development of potential therapeutics for cancers, viruses and autoimmune disorders. As the Company has one reportable segment, research and development, and general and administrative expenses are equal to consolidated results. Financial results for the Company’s reportable segment have been prepared using a management approach, which is consistent with the basis and manner in which financial information is evaluated by the Company’s Chief Operating Decision Maker (“CODM”) in allocating resources and in assessing performance. The Company’s CODM is the Chief Executive Officer. Actual financial results used by the CODM to assess performance and allocate resources, as well as strategic decisions related to headcount and other expenditures, are reviewed on a consolidated basis.
(3) Marketable Securities
Marketable securities consist of mutual funds. At December 31, 2024 and December 31, 2023, it was determined that none of the marketable securities had an other-than-temporary impairment. At December 31, 2024 and December 31, 2023, all securities were measured as Level 1 instruments of the fair value measurements standard (See Note 15: Fair Value ). At December 31, 2024, and December 31, 2023 the Company held $2,276,000 and $7,631,000 respectively, in mutual funds.
Mutual Funds classified as available for sale consisted of $2,276,000 at December 31, 2024. The net loss recognized for the year ended December 31, 2024 on equity securities was ($93,000). The net losses recognized for the year ended December 31, 2024 on equity securities sold during the period were ($663,000). The unrealized gains recognized for the year ended December 31, 2024 on equity securities still held was $570,000.
Mutual Funds classified as available for sale consisted of $7,631,000 at December 31, 2023. The net gain recognized for the year ended December 31, 2023 on equity securities was $200,000. The net losses recognized for the year ended December 31, 2023 on equity securities sold during the period were ($176,000). The unrealized gain recognized during the year ended December 31, 2023 on equity securities still held was $376,000.
(4) Patents and Trademark Rights, Net
Patent and trademark rights consist of the following (in thousands):
| December 31, 2024 | December 31, 2023 | |||||
|---|---|---|---|---|---|---|
| Gross Carrying Value | Accumulated Amortization | Net Carrying Value | Gross Carrying Value | Accumulated Amortization | Net Carrying Value | |
| Patents | $3,434 | $(939) | $2,495 | $2,947 | $(750) | $2,197 |
| Trademarks | 232 | (133) | 99 | 229 | (113) | 116 |
| Net amortizable patents and trademarks rights | $3,666 | $(1,072) | $2,594 | $3,176 | $(863) | $2,313 |
Patent and trademark rights acquisitions, abandonments and amortization:
| December 31, 2023 | $2,313 |
|---|---|
| Acquisitions | 538 |
| Abandonments and expirations | (48) |
| Amortization | (209) |
| December 31, 2024 | $2,594 |
Patents and trademarks are stated at cost (primarily legal fees) and are amortized using the straight-line method over an estimated useful life of 17 years for patents and 10 years for trademarks. The weighted remaining average amortization period is approximately 12 years for patents and 6 years for trademarks, respectively. The company expenses annuity costs related to its trademarks and patents.
Amortization of patents and trademarks for each of the next five years and thereafter is as follows (in thousands):
| Year Ending December 31, | |
|---|---|
| 2025 | $283 |
| 2026 | 278 |
| 2027 | 249 |
| 2028 | 229 |
| 2029 | 211 |
| Thereafter | 1,344 |
| Total | $2,594 |
(5) Accrued Expenses
Accrued expenses at December 31, 2024 and 2023 consist of the following:
| (in thousands) December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Compensation | $1 | $414 |
| Professional fees | 416 | 1,352 |
| Clinical trial expenses | 145 | 184 |
| Interest | 11 | — |
| Other expenses | 33 | 36 |
| Total | $606 | $1,986 |
(6) Unsecured Promissory Note
On February 16, 2024, the Company (“Borrower”) entered into a Note Purchase Agreement with Streeterville Capital LLC (“Streeterville” or the “Lender”). Under the terms of the agreement, Streeterville paid the Company $2,500,000 in exchange for an unsecured promissory Note with an Original Issue Discount of $781,250. The Company will pay $3,301,250 consisting of the principal amount of the Note, together with the original issue discount and $20,000 of lender transaction fees, no later than February 16, 2026. The stated interest rate of the note is 10%. There wasno debt at December 31, 2023.
| Debt schedule at December 31, 2024 (in thousands) | |
|---|---|
| Long-term debt | $2,807 |
| Unamortized Original issue discount | (489) |
| Unamortized Financing fees | (11) |
| Unamortized discount and debt issuance costs | 2,307 |
| Less current portion of long-term debt, net | (2,307) |
| Long-term debt, net | $— |
Future maturities for long-term debt as of December 31, 2024 were as follows:
(in thousands)
| Fiscal years ending December 31: | |
|---|---|
| 2025 | $2,807 |
| Total | $2,807 |
Interest expense related to long-term debt was $292,000 at December 31, 2024. Amortization expenses related to long-term debt was $302,000 at December 31, 2024. This consisted of $293,000 in original issue discount and $9,000 for loan fee amortization. Future maturities of long-term debt at December 31, 2024 were $2,807,000 for fiscal years ending December 31, 2025.
Current portion of long-term debt of approximately $2,807,000 is net of the current portion of debt discount of approximately $489,000 and the current portion of debt origination costs of approximately $11,000 as of December 31, 2024.
The agreement allows the Lender to redeem up to $250,000 per calendar month beginning in August 2024, upon providing written notice to Borrower. The Note further contains triggering events which can be remedied by the Lender requiring the Borrower to correct the triggering event, increasing the outstanding balance by applying the triggering effect, or making the Note immediately due and payable.
(7) Stockholders’ Equity
(a) Preferred Stock
The Company is authorized to issue 5,000,000 shares of $0.01 par value preferred stock with such designations, rights and preferences as may be determined by the Board. Of our authorized preferred stock,4,000,000 shares have been designated as Series A Junior Participating Preferred Stock and 10,000 shares have been designated as Series B Convertible Preferred Stock.
Series A Junior Participating Preferred Stock
On May 10, 2023, the Company filed a Certificate of Increase in Delaware, increasing the number of preferred stock designated as Series A Junior Participating Preferred Stock to 4,000,000 from 250,000 shares. As of December 31, 2024, there were no Series A Junior Participating Preferred Stock outstanding.
Series B Convertible Preferred Stock
The Company has designated 10,000 shares of its preferred stock as Series B Convertible Preferred Stock (the “Preferred Stock”). Each share of Preferred Stock has a par value of $0.01 per share and a stated value equal to $1,000 (the “Stated Value”). The shares of Preferred Stock shall initially be issued and maintained in the form of securities held in book-entry form and the Depository Trust Company or its nominee (“DTC”) shall initially be the sole registered holder of the shares of Preferred Stock.
Each share of Preferred Stock shall be convertible, at any time and from time to time from and after the Original Issue Date at the option of the Holder thereof or at any time and from time to time on or after the second anniversary of the Original Issue Date at the option of the Corporation, into that number of shares of common stock (subject in each case to the limitations determined by dividing the Stated Value of such share of Preferred Stock by the Conversion Price). The conversion price for the Preferred Stock shall be equal to $0.20, subject to adjustment herein (the “Conversion Price”).
Pursuant to a registration statement relating to a rights offering (the “Rights Offering”) declared effective by the SEC on February 14, 2019, AIM distributed to its holders of common stock and to holders of certain options and redeemable warrants as of February 14, 2019, at no charge, one non-transferable subscription right for each share of common stock held or deemed held on the record date. Each right entitled the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of Series B Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into common stock at an assumed conversion price of $8.80) and 114 warrants with an assumed exercise price of $8.80. The redeemable warrants are exercisable for five years after the date of issuance. The net proceeds realized from the rights offering were approximately $4,700,000. As of December 31, 2024,689 shares of Series B Convertible Preferred Stock had expired, and none were converted prior to expiration.
(b) Common Stock and Equity Finances
The Company has authorized shares of 350,000,000 with specific limitations and restrictions on the usage of 8,000,000 of the 350,000,000 authorized shares. As of December 31, 2024, and December 31, 2023, there were 65,526,320 and 49,102,484 shares of common stock issued and outstanding, respectively.
Employee Stock Purchase Plan (Not equity compensation)
On July 7, 2020, the Board approved a plan pursuant to which all directors, officers, and employees could purchase from the Company up to an aggregate of $500,000 worth of shares at the market price (including subsequent plans, the “Employee Stock Purchase Plan”). Pursuant to NYSE American rules, this plan was effective for a sixty-day period commencing upon the date that the NYSE American approved the Company’s Supplemental Listing Application. The Company created successive new plans following the expiration of the July 7, 2020 plan. The latest plan was approved by the Board on March 6, 2025 and expires in May 2025.
During the year ended December 31, 2024, the Company issued a total of 395,713 shares of its common stock at a price ranging from $0.18 to $0.41 for total proceeds of approximately $131,000 as part of the employee stock purchase plan.
During the year ended December 31, 2023, the Company issued a total of 419,285 shares of its common stock at a price ranging from $0.31 to $0.67 for total proceeds of approximately $150,500 as part of the employee stock purchase plan.
Rights Plan
On May 12, 2023, the Company amended and restated its November 14, 2017 Rights Plan with American Stock Transfer & Trust Company as Rights Agent (the “Rights Plan”).
Warrants (Rights offering)
On September 27, 2019, the Company closed a public offering underwritten by A.G.P./Alliance Global Partners, LLC (the “Offering”) of (i)1,740,550 shares of common stock; (ii) pre-funded warrants exercisable for 7,148,310 shares of common stock (the “Pre-funded Warrants”), and (iii) warrants to purchase up to an aggregate of 8,888,860 shares of common stock (the “Warrants”). In conjunction with the Offering, we issueda Representative’s Warrant to purchase up to an aggregate of 266,665 shares of common stock (the “Representative’s Warrant”). The shares of common stock and Warrants were sold at a combined Offering price of $0.90, less underwriting discounts and commissions. Each Warrant sold with the shares of common stock represents the right to purchase one share of common stock at an exercise price of $0.99 per share. The Pre-Funded Warrants and Warrants were sold at a combined Offering price of $0.899, less underwriting discounts and commissions. The Pre-Funded Warrants were sold to purchasers whose purchase of shares of common stock in the Offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% of the Company’s outstanding common stock immediately following the consummation of the Offering, in lieu of shares of common stock. Each Pre-Funded Warrant represents the right to purchase one share of common stock at an exercise price of $0.001 per share. The Pre-Funded Warrants are exercisable immediately and may be exercised at any time until the Pre-Funded Warrants are exercised in full. A registration statement on Form S-1, relating to the Offering was filed with the SEC and was declared effective on September 25, 2019, the net proceeds were approximately $7,200,000. During the year ended December 31, 2020,1,870,000 of the Pre-funded Warrants were exercised and 8,873,960 Warrants were exercised. In addition, on March 25, 2020, the Representative’s Warrant was amended to permit exercise of such warrant to commence on March 30, 2020. These warrants were exercised on March 31, 2020, and an aggregate of 266,665 shares were issued upon exercise of this warrant for gross proceeds of approximately $264,000 and a $46,000 expense for the warrant modification.
During the year ended December 31, 2024,205,000 warrants were exercised, and 5,830,028 warrants expired unexercised. No warrants were exercised during the year ended December 31, 2023. At December 31, 2024 there wereno warrants outstanding and December 31, 2023 there were 15,000 warrants outstanding.
Equity Distribution Agreement
On April 19, 2023, we entered into an Equity Distribution Agreement (the “EDA”), with Maxim, pursuant to which we may sell from time to time, shares of our common stock having an aggregate offering price of up to $8.5 million through Maxim, as agent. The amount was subsequently reduced from $8.5 million to $3.1 million. Sales under the EDA were registered under the S-3 Shelf Registration Statement. Under the terms of the Distribution Agreement, Maxim is entitled to a transaction fee at a fixed rate of 3.0% of the gross sales price of shares sold under the EDA. For the year ended December 31, 2024, we sold 1,395,612 shares under the EDA for total gross proceeds of approximately $649,916, which includes a 3.0% fee to Maxim of $19,497. During the year ended December 31, 2023, we sold 598,114 shares under the EDA for total gross proceeds of approximately $344,000, which includes a 3.0% fee to Maxim of $10,326. Subsequent to December 31, 2024, the Company has sold 1,119,106 shares under the EDA for total gross proceeds of approximately $259,800, which includes a 3.0% fee to Maxim of approximately $7,800.
Equity Purchase Agreement
On March 28, 2024, the Company entered into a purchase agreement and a registration rights agreement with Atlas Sciences, LLC (“Atlas”), pursuant to which Atlas committed to purchase up to $15,000,000 of common stock of the Company for a period of 24 months from the date of the purchase agreement. No assurance can be given as to the actual amount that will be raised pursuant to the purchase agreement.
Under the terms of the purchase agreement, the Company, at its sole discretion, shall have the right to issue Put shares to the Investor at 95% of the Market Price of the shares on the day of trade. Sales under the purchase agreement are limited to a daily maximum of the lessor of: $500,000, the Median Daily Trading volume, and a beneficial ownership limitation of 4.99% and a maximum of 19.99% of the outstanding shares at the time of the purchase agreement. In April 2024, the Company filed a registration statement with the SEC on Form S-1 registering a total of 9,975,000 shares for resale pursuant to the Atlas Agreements, consisting of 9,636,400 shares that can be sold by the Company to Atlas and 338,600 shares that were issued to Atlas as Commitment Shares. The registration statement was declared effective on May 1, 2024. As of December 31, 2024, a total of 759,685 shares have been issued pursuant to the purchase agreement for a total of approximately $128,000 after clearing costs. Subsequent to December 31, 2024, a total of 3,082,961 shares have been issued pursuant to the purchase agreement for a total of approximately $398,000 after clearing costs.
Securities Purchase Agreement
On May 31, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) to complete an offering (the “Transactions”) with a single accredited investor (the “Purchaser”), pursuant to which, on June 3, 2024, the Company issued to the Purchaser, (i) in a registered direct offering,5,640,958 shares of the Company’s common stock (the “Shares”), par value $0.001 per share (“common stock”) and (ii) in a concurrent private placement, the Company issued to the Purchaser Class A common warrants to purchase an aggregate of up to 5,640,958 shares of its common stock (the “A Warrants”) at an exercise price of $0.363 per share and Class B common warrants to purchase an aggregate of up to 5,640,958 shares of its common stock (the “B “Warrants” and, along with the A Warrants, the “Common Warrants”) at an exercise price of $0.363 per share. The A Warrants and B Warrants are not exercisable for six months after the issuance date and expire, respectively, 24 months and five years and six months after the issuance date. The Common Warrants and the shares of common stock issuable upon the exercise of such warrants are offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.
The Shares were offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-262280), which was declared effective on February 4, 2022 (as amended from time to time, the “Registration Statement”).
Pursuant to the terms of the Purchase Agreement, subject to certain exceptions, the Company could not issue any equity securities for 60 days following the issuance date, provided that the Company was able to utilize its at-the-market offering program with the Placement Agent after 30 days. Additionally, the Company cannot enter into a variable rate transaction (other than the ATM program with the Placement Agent) for 120 days after the issuance date. In addition, the Company’s executive officers and each of the Company’s directors have entered into lock-up agreements with the Company pursuant to which each of them has agreed not to, for a period of 90 days from the closing of the Transactions, offer, sell, transfer or otherwise dispose of the Company’s securities, subject to certain exceptions.
The exercise price of the Common Warrants, and the number of Common Warrant Shares, are subject to adjustment in the event of any stock dividend or split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Common Warrants. If a Fundamental Transaction (as defined in the Common Warrants) occurs, then the successor entity will succeed to, and be substituted for the Company, and may exercise every right and power that the Company may exercise and will assume all of its obligations under the Common Warrants with the same effect as if such successor entity had been named in the warrant itself. Common Warrant Holders will have additional rights defined in the Common Warrants. The Common Warrants are exercisable on a “cashless” basis only if there is not a current registration statement permitting public resale. In this regard, the Company filed a registration statement to register the resale of the Common Warrant Shares providing for the resale of the Shares issued and issuable upon exercise of the Common Warrants. That registration statement was declared effective by the SEC on July 11, 2024. The Company has agreed to use commercially reasonable efforts to cause such registration statement to keep such registration statement effective at all times until no Purchaser owns any Warrants or Warrant Shares issuable upon exercise thereof.
Maxim Group LLC acted as the placement agent (the “Placement Agent”) on a “commercially reasonable best efforts” basis, in connection with the Transactions pursuant to the Placement Agency Agreement, dated May 31, 2024 (the “Placement Agency Agreement”), by and between the Company and the Placement Agent. Pursuant to the Placement Agency Agreement, the Placement Agent was paid a cash fee of 8% of the aggregate gross proceeds paid to the Company for the securities sold in the Transactions and reimbursement of certain out-of-pocket expenses.
The Company evaluated the Common Warrants under the guidance of ASC 480 – Distinguishing Liabilities from Equity and determined that they were in scope under the guidance as freestanding financial instruments but did not meet the criteria for liability classification and are classified as equity within the consolidated financial statements. Proceeds allocated to such warrants totaled approximately $2.5 million. For the year ended December 31,2024, no Common Warrants were exercised, and all remain outstanding on December 31, 2024 related to this agreement.
On September 30, 2024, the Company entered into a Purchase Agreement with the Selling Stockholder as Purchaser, pursuant to which we issued to the Selling Stockholder, (i) in a registered direct offering,4,653,036 shares of our Common Stock (“Shares”) and (ii) in the concurrent Private Placement, Class C and Class D Warrants, each to purchase an aggregate of up to 4,653,036 Shares (the “Common Warrant Shares”) each with an exercise price of $0.28. The Class C and Class D Warrants together, hereinafter the “Common Warrants”. The purchase price for Shares in the registered direct offering was $0.27 per Share.
The Company received aggregate gross proceeds from the Transactions of approximately $1.26 million, before deducting fees to the Placement Agent and other estimated offering expenses payable by us. The Shares were offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-262280), which was declared effective on February 4, 2022. The Common Warrants and the Common Warrant Shares issued in the Private Placement were not registered under the Securities Act. Rather the Common Warrants and the Common Warrant Shares were issued pursuant to the exemption from registration provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder. The Class C Warrants and the Class D Warrants are not exercisable until December 3, 2024, and will expire, respectively, 24 months and five years and six months after that date.
(c) Common Stock Options and Warrants
(i) Stock Options
The 2018 Equity Incentive Plan, effective September 12, 2018, authorizes the grant of (i) Incentive Stock Options, (ii) Nonstatutory Stock Options, (iii) Stock Appreciation Rights, (iv) Restricted Stock Awards, (v) Restricted Stock Unit Awards, (vi) Performance Stock Awards, (vii) Performance Cash Awards, and (viii) Other Stock Awards. Initially, a maximum of 7,000,000 shares of common stock is reserved for potential issuance pursuant to awards under the 2018 Equity Incentive Plan. Unless sooner terminated, the 2018 Equity Incentive Plan will continue in effect for a period of 10 years from its effective date.
The Equity Incentive Plans of 2018 are administered by the Board of Directors. The Plans provide for awards to be made to such Officers, other key employees, non-employee Directors, consultants and advisors of the Company and its subsidiaries as the Board may select.
Stock options awarded under the Plans may be exercisable at such times (not later than 10 years after the date of grant) and at such exercise prices (not less than fair market value at the date of grant) as the Board may determine. The Board may provide for options to become immediately exercisable upon a “change in control”, which is defined in the Plans to occur upon any of the following events: (a) the acquisition by any person or group, as beneficial owner, of 20% or more of the outstanding shares or the voting power of the outstanding securities of the Company; (b) either a majority of the Directors of the Company at the annual stockholders meeting has been nominated other than by or at the direction of the incumbent Directors of the Board, or the incumbent Directors cease to constitute a majority of the Company’s Board; (c) the Company’s stockholders approve a merger or other business combination pursuant to which the outstanding common stock of the Company no longer represents more than 50% of the combined entity after the transaction; (d) the Company’s stockholders approve a plan of complete liquidation or an agreement for the sale or disposition of all or substantially all of the Company’s assets; or (e) any other event or circumstance determined by the Company’s Board to affect control of the Company and designated by resolution of the Board as a change in control.
The fair value of each option award is estimated on the date of grant using a Black-Scholes-Merton pricing option valuation model. Expected volatility is based on the historical volatility of the price of the Company’s stock. The risk-free interest rate is based on U.S. Treasury issues with a term equal to the expected life of the option and equity warrant. The Company uses historical data to estimate expected dividend yield, life and forfeiture rates. The expected life of the options and equity warrants was estimated based on historical option and equity warrant holders’ behavior and represents the period of time that options and equity warrants are expected to be outstanding. The fair values of the options granted were estimated based on the following weighted average assumptions:
During the year ended December 31, 2023, we issued a total of 400,000 options under the 2018 Equity Incentive Plan, effective September 12, 2018, which will continue in effect for a period of 10 years from its effective date.
During the year ended December 31, 2024, we did not issue any options under the 2018 Equity Incentive Plan, However, pursuant to employment agreements for certain executives,400,000 options were deferred to assure that a sufficient number of shares are available under the 2018 Equity Incentive Plan should they be needed, in the Company opinion, to focus on the Company’s financial resources to further its Ampligen R&D Activities, This deferral is in effect until the Company no longer needs the shares underlying the options reserved from the shares available for issuance under the Plan, or the Company agrees otherwise. During this deferral, the shares underlying the options are still deemed reserved under the Plan.
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Risk-free interest rate | — | 4.37% |
| Expected dividend yield | — | — |
| Expected life | — | 10 years |
| Expected volatility | — | 99.91% |
| Weighted average grant date fair value for options issued | — | $0.43 per option for 400,000 options |
The exercise price of all stock options and equity warrants granted was equal to or greater than the fair market value of the underlying common stock on the date of the grant.
Information regarding the options approved by the Board of Directors under the Equity Plan of 2009 is summarized below. The plan expired on June 24, 2019:
| 2024 | 2023 | |||||
|---|---|---|---|---|---|---|
| Shares | Option Price | Weighted Average Exercise Price | Shares | Option Price | Weighted Average Exercise Price | |
| Outstanding, beginning of year | 119,352 | $13.20-2,127.84 | $20.72 | 124,399 | $13.20 – 1,003.20 | $22.23 |
| Granted | — | — | — | — | — | — |
| Forfeited | — | — | — | (5,047) | 9.68-327.36 | 57.79 |
| Expired | (901) | 190 | $356.36 | — | — | — |
| Outstanding, end of year | 118,451 | $13.20-2,127.84 | $18.17 | 119,352 | $13.20-2,127.84 | $20.72 |
| Exercisable, end of year | 118,451 | $13.20-2,127.84 | $18.17 | 119,352 | $13.20-2,127.84 | |
| Weighted average remaining contractual life (years) | 3.08 years | 4.06 years | ||||
Information regarding the options approved by the Board of Directors under the Equity Plan of 2018 is summarized below:
| 2024 | 2023 | |||||
|---|---|---|---|---|---|---|
| Shares | Option Price | Weighted Average Exercise Price | Shares | Option Price | Weighted Average Exercise Price | |
| Outstanding, beginning of year | 2,814,142 | $0.31-9.68 | $1.54 | 2,474,971 | $0.31-9.68 | $1.72 |
| Granted | — | — | — | 400,000 | 0.47-0.47 | 0.47 |
| Forfeited | — | — | — | (60,829) | 0.31-9.68 | 1.98 |
| Outstanding, end of year | 2,814,142 | $0.31-9.68 | $1.54 | 2,814,142 | $0.31-9.68 | $1.54 |
| Exercisable, end of year | 2,814,142 | $0.31-9.68 | $1.54 | 2,397,474 | $0.31-327.36 | 4.71 |
| Weighted average remaining contractual life (years) | 6.96 years | 7.96 years | ||||
| Available for future grants | 487,050 | 1,210,286 | ||||
Stock option activity during the years ended December 31, 2024 and 2023 is as follows:
Vested stock option activity for employees:
| Number of Options | Weighted Average Exercise Price | Weighted Average Remaining Contracted Term (Years) | Aggregate Intrinsic Value | |
|---|---|---|---|---|
| Outstanding December 31, 2022 | 2,020,214 | $3.01 | 8.86 | — |
| Granted | 400,000 | 0.47 | 10.17 | — |
| Forfeited | (7,601) | 9.68 | — | — |
| Expired | (4,175) | 41.61 | — | — |
| Outstanding December 31, 2023 | 2,408,438 | $2.50 | 8.70 | — |
| Granted | — | — | — | — |
| Forfeited | — | — | — | |
| Expired | (806) | — | — | — |
| Outstanding December 31, 2024 | 2,407,632 | $2.42 | 8.70 | — |
| Vested and expected to vest at December 31, 2024 | 2,407,632 | $2.42 | 8.70 | — |
| Exercisable at December 31, 2024 | 2,407,632 | $1.61 | 7.26 | — |
The weighted-average grant-date fair value of employee options vested during the year ended December 31, 2024 was approximately $172,000 for 366,667 options at $0.47 per option and during year ended December 31, 2023 was approximately $184,000 for 424,999 options at $0.43 per option.
Unvested stock option activity for employees:
| Number of Options | Weighted Average Exercise Price | Average Remaining Contracted Term (Years) | Aggregate Intrinsic Value | |
|---|---|---|---|---|
| Unvested December 31, 2022 | 392,326 | $0.80 | 8.86 | — |
| Granted | 400,000 | 0.47 | 10.17 | — |
| Vested | (413,884) | 1.90 | 6.73 | — |
| Forfeited | (7,601) | 9.68 | — | — |
| Expired | (4,175) | 41.61 | — | — |
| Unvested December 31, 2023 | 366,666 | $2.13 | 12.44 | — |
| Granted | — | — | — | — |
| Vested | (365,860) | 0.47 | 7.26 | — |
| Forfeited | — | — | — | — |
| Expired | (806) | — | — | — |
| Unvested December 31, 2024 | — | $— | — | — |
Vested stock option activity for non-employees:
| Number of Options | Weighted Average Exercise Price | Weighted Average Remaining Contracted Term (Years) | Aggregate Intrinsic Value | |
|---|---|---|---|---|
| Outstanding December 31, 2022 | 579,155 | $3.09 | 8.36 | — |
| Granted | 360,000 | 0.46 | 10.04 | — |
| Expired | (653) | 145.24 | — | — |
| Forfeited | (53,447) | 1.31 | — | — |
| Outstanding December 31, 2023 | 885,055 | $2.02 | 9.23 | — |
| Granted | — | — | — | — |
| Exercised | — | — | — | — |
| Expired | (95) | — | — | — |
| Forfeited | — | — | — | — |
| Outstanding December 31, 2024 | 884,960 | $1.88 | 9.23 | — |
| Vested and expected to vest at December 31, 2024 | 884,960 | $1.88 | 9.23 | — |
| Exercisable at December 31, 2024 | 884,960 | $1.62 | 9.51 | — |
The weighted-average grant-date fair value of non-employee options vested during year 2024 was approximately $131,000 for 285,000 options at $0.46 per option and during the year 2023 was approximately $90,000 for 191,666 options at $0.47 per option.
Unvested stock option activity for non-employees:
| Number of Options | Weighted Average Exercise Price | Weighted Average Remaining Contracted Term (Years) | Aggregate Intrinsic Value | |
|---|---|---|---|---|
| Unvested December 31, 2022 | 166,789 | $4.05 | 9.49 | — |
| Granted | 360,000 | 0.46 | 10.18 | — |
| Vested | (137,565) | 0.47 | 9.47 | — |
| Expired | (776) | 145.24 | — | — |
| Forfeited | (53,447) | 1.31 | — | — |
| Unvested December 31, 2023 | 335,001 | $1.83 | 10.70 | — |
| Granted | — | — | — | — |
| Vested | (334,906) | 0.46 | 10.18 | — |
| Expired | (95) | — | — | — |
| Forfeited | — | — | — | — |
| Unvested December 31, 2024 | — | — | — | — |
Stock-based compensation expense was approximately $686,000 and $243,000 for the years ended December 31, 2024 and 2023.
As of December 31, 2024 all stock-based compensation cost related to options granted under the Equity Incentive Plans had been recognized. As of December 31, 2023, there was $294,000 of unrecognized stock-based compensation cost related to options granted under the Equity Incentive Plans. Stock-based compensation related to options granted under the Equity Incentive Plans is recorded over the vesting period, which is typically one year or upon reaching the agreed upon Company and/or individual performance milestones being met which is indefinite.
(ii) Stock Warrants
Stock warrants are issued as needed by the Board of Directors and have no formal plan.
The fair value of each warrant award is estimated on the date of grant using a Black-Scholes-Merton pricing option valuation model. Expected volatility is based on the historical volatility of the price of the Company’s stock. The risk-free interest rate is based on U.S. Treasury issues with a term equal to the expected life of the warrant. The Company uses historical data to estimate expected dividend yield, life and forfeiture rates. The expected life of the warrants was estimated based on historical option holder’s behavior and represents the period of time that options are expected to be outstanding. No warrants were granted in 2023.
Information regarding warrants outstanding and exercisable into shares of common stock is summarized below:
| 2024 | 2023 | |||||
|---|---|---|---|---|---|---|
| Shares | Warrant Price | Weighted Average Exercise Price | Shares | Warrant Price | Weighted Average Exercise Price | |
| Outstanding, beginning of year | 152,160 | $0.99-8.80 | $8.03 | 226,610 | $0.99-132.00 | $9.10 |
| Granted | 20,587,988 | 0.28-0.363 | 0.33 | — | — | — |
| Expired | (147,501) | 0.99-8.80 | 8.03 | (74,450) | 17.05 | 17.05 |
| Exercised | (4,659) | 8.80 | 8.80 | — | — | — |
| Outstanding, end of year | 20,587,988 | $0.28-0.363 | $0.33 | 152,160 | $ 0.99-8.80 | $8.03 |
| Exercisable | 11,281,916 | $0.363 | $0.363 | 152,160 | $ 0.99-8.80 | $8.03 |
| Weighted average remaining contractual life | 3.75 years | .75 years | ||||
| Years exercisable | 2025 | 2024 | ||||
Stock warrants are issued at the discretion of the Board. During the year ended December 31, 2024, there were 20,587,988 warrants issued,4,659 warrants were exercised and 147,501 warrants expired. During the year ended December 31, 2023, there were no warrants issued or exercised.
(8) Research, Consulting and Supply Agreements
The Company has entered into research, consulting and supply agreements with third party service providers to perform research and development activities on therapeutics, including clinical trials. The identification of research and development costs involves reviewing open contracts and purchase orders, communicating with applicable company and third-party personnel to identify services that have been performed, and corroborating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of actual expenses. The Company expenses these research and development costs when incurred.
During the year ended December 31, 2024, research and development expenses were comprised of: clinical studies ($2,627,000), manufacturing and engineering ($1,116,000), quality control ($1,721,000) and regulatory ($733,000).
During the year ended December 31, 2023, research and development expenses were comprised of: clinical studies ($6,014,000), manufacturing and engineering ($3,220,000), quality control ($1,271,000) and regulatory ($434,000).
The following summarizes the most substantial of our contracts relating to research, consulting, and supply costs for AIM as they related to research and development costs for the year ended December 31, 2024.
Amarex Clinical Research LLC
Amarex is the principal administrator of several of AIM’s largest clinical studies. AIM has multiple contracts with Amarex Clinical Research LLC (“Amarex”). During the years ended December 31, 2024 and 2023, the Company incurred approximately $1,047,800 and $4,290,000, respectively, related to these ongoing agreements:
| ● | Pancreatic Cancer - In April 2022, AIM executed a work order with Amarex pursuant to which Amarex is managing a Phase 2 clinical trial in locally advanced pancreatic cancer patients designated AMP-270. Per the work order, AIM anticipates that Amarex’s management of the study will cost approximately $8,400,000. This estimate includes pass-through costs of approximately $1,000,000 and excludes certain third-party and investigator costs and escalations necessary for study completion. AIM anticipates that the study will take approximately 4.6 years to complete. |
| ○ | During the year ended December 31, 2024, the Company incurred approximately $458,800 related to this agreement. |
| ○ | During the year ended December 31, 2023, the Company incurred approximately $600,000 related to this agreement. |
| ● | Post-COVID Conditions - In September 2022, AIM executed a work order with Amarex, pursuant to which Amarex is managing a Phase 2 trial in patients with Post-COVID Conditions. AIM is sponsoring the study. AIM anticipates that the study will cost approximately $6,400,000, which includes pass-through costs of approximately $125,000, investigator costs estimated at about $4,400,000 and excludes certain other third-party costs and escalations. During 2023, the original work order increased to approximately $6,600,000 for the addition of patient reported outcome (PRO) electronic questionnaires (devices/tablets for patients to complete); services associated with the ePRO system and additional safety monitoring services as well as changes to study documentation (such as protocol amendments) which resulted in additional IND submissions to FDA. This study was completed in 2023, although certain activities are still ongoing. |
| ○ | During the year ended December 31, 2024, the Company incurred approximately $455,000 related to this agreement. |
| ○ | During the year ended December 31, 2023, the Company incurred approximately $3,690,000 related to this agreement. |
Jubilant HollisterStier
Jubilant HollisterStier (“Jubilant”) is AIM’s authorized CMO for Ampligen for the approval in Argentina. In 2017, the Company entered into an agreement with Jubilant pursuant to which Jubilant will manufacture batches of Ampligen® for the Company. Since the 2017 engagement of Jubilant, two lots of Ampligen consisting of more than 16,000 units were manufactured and released in the year 2018. The first lot was designated for human use in the United States in the cost recovery CFS program and for expanded oncology clinical trials. The second lot has been designated for these programs in addition to commercial distribution in Argentina for the treatment of CFS. Jubilant manufactured additional two lots of Ampligen in December 2019 and January 2020. In December 2023, Jubilant completed manufacturing of 9,042 vials of Ampligen for clinical use.
| ○ | During the year ended December 31, 2024, the Company incurred approximately $1,200 related to this agreement. |
| ○ | During the year ended December 31, 2023, the Company incurred approximately $1,432,000 related to this agreement. |
Sterling Pharma Solutions
In 2022, the Company entered into a Master Service Agreement and a Quality Agreement with Sterling Pharma Solutions (“Sterling”) for the manufacture of the Company’s Poly I and Poly C12U polynucleotides and transfer of associated test methods at Sterling’s Dudley, UK location to produce the polymer precursors to manufacture the drug Ampligen.
| ○ | During the year ended December 31, 2024, the Company incurred approximately $498,300 related to this agreement. |
| ○ | During the year ended December 31, 2023, the Company incurred approximately $363,000 related to this agreement. |
Erasmus
In December 2022, the Company entered into a joint clinical study agreement with Erasmus University Medical Center Rotterdam to conduct a Phase II study: Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy efficacy. This is a study in collaboration with AstraZeneca. AIM’s limited responsibilities are limited to providing Ampligen. Additionally, in April 2023 AIM agreed to provide to Erasmus MC an unrestricted grant of $200,000 for immune monitoring in pancreatic cancer patients.
| ○ | During the year ended December 31, 2024, the Company incurred approximately $104,300 related to this agreement. |
| ○ | During the year ended December 31, 2023, the Company incurred approximately $100,000 related to this agreement. |
Azenova Sales International
In October 2023, the Company entered into a consulting agreement with Azenova, LLC whereas Azenova will provide business development services for AIM’s Ampligen product for solid tumors for a 12-month term that is extendable upon the agreement of the parties. In exchange for its services, Azenova will receive a fixed monthly retainer of $30,000 per month in addition to 360,000 stock options that vest monthly. In August 2024, an agreement was made to reduce the fixed monthly retainer fee to $10,000. This agreement was further adjusted to solely include specific services performed.
On December 6, 2023, the Company issued to Azenova, LLC, an option to purchase up to three hundred and sixty thousand (360,000) shares of our “Common Stock” at a price equal to $0.46 per share. This Option was awarded pursuant to the Consulting Agreement dated October 16, 2023 between the Company and Azenova, LLC. On December 6, 2023,180,000 options were transferred to Jeffrey Southerton and 180,000 options were transferred to Stacy J. Evans; both transfers with an exercise price of $0.46.
The offers, sales and issuances of securities described above was deemed to be exempt from registration under the Securities Act in reliance on either Section 4(a)(2) in that the issuance of securities to the accredited investors did not involve a public offering, or Rule 701 in that the transactions were under compensatory benefit plans and contracts relating to compensation as provided under Rule 701.
| ○ | During the year ended December 31, 2024, the Company incurred approximately $255,000 related to this agreement. |
| ○ | During the year ended December 31, 2023, the Company incurred approximately $75,500 related to this agreement. |
Alcami
In September 2023, the Company entered into an agreement with Alcami Corporation to perform an extractables study for a primary packaging component. The agreement called for fixed costs of approximately $30,000 upon completion of the study and issue of the final report, along with solvent costs, and pass through items to be billed on a per activity basis. The final bill for the initial study was received in December 2023.
| ○ | During the year ended December 31, 2024, the Company incurred approximately $14,000 of lab services from Alcami. |
| ○ | During the year ended December 31, 2023, the Company incurred approximately $64,500 of lab services from Alcami. |
(9) 401(k) Plan
AIM has a defined contribution plan, entitled the AIM ImmunoTech Employees 401(k) Plan and Trust Agreement (the “401(k) Plan”). AIM’s full-time employees are eligible to participate in the 401(k) Plan following 61 days of employment. Subject to certain limitations imposed by federal tax laws, participants are eligible to contribute up to 15% of their salary (including bonuses and/or commissions) per annum. Participants’ contributions to the 401(k) Plan may be matched by us at a rate determined annually by the Board.
Each participant immediately vests in his or her deferred salary contributions as well as the Company’s safe harbor contributions. A 6% safe harbor matching contribution by us was reinstated effective January 1, 2021. For the year ended December 31, 2024 and 2023, the Company’s matching contributions were approximately $167,000 and $162,000, respectively
(10) Employment/Consulting Agreements
The Company had contractual agreements with certain Named Executive Officers (“NEO”) in 2024 and 2023. The aggregate annual base compensation which includes bonuses and stock issuances for these NEO under their respective contractual agreements for 2024 (which takes into account amendments to these agreements effected in September 2024), and 2023 was $1,491,215 and $1,839,484, respectively. As part of the Company’s cash conservation strategy, certain NEOs were issued common stock in 2024 as a substitute for cash salaries. For the year ended December 31, 2024, stock issued as payroll totaled $250,000, which is included in the overall equity-based compensation expense. There was no stock issued as payroll for the year ended December 31, 2023. In addition, certain Officers were entitled to receive performance bonuses of up to 25% or 20% of their respective annual base salary, at the sole discretion of the Compensation Committee of the Board of Directors. For the years December 31, 2024 and 2023, there were no performance bonuses paid out. For the year ended December 31, 2023, Officers’ bonuses were $450,000 and were deferred and paid in 2024. An additional $50,000 was awarded retroactively in 2024 for 2023. For the year ended December 31, 2024, Officers’ bonuses were electively waived by the Officers.
In 2024, the Company reserved equity compensation for later issuance to these Officers.
| a. | The Company reserved 300,000 ten-year options to be issued at a later date for Thomas K. Equels, Chief Executive Officer. |
|---|
| b. | The Company reserved 100,000 ten-year options to be issued at a later date for Peter Rodino, Chief Operating Officer and General Counsel. |
|---|
The Company recorded stock compensation expense of approximately $156,600 during the year ended December 31, 2024 with regard to the 2023 issuances to Officers Equels and Rodino. The Company did not record stock compensation expense for the 2024 reserved options.
In 2023, equity was granted as a form of compensation to these Officers.
| c. | The Company granted 300,000 ten-year options to purchase common stock with an exercise price of $0.47 per share to vest in one year to Thomas K. Equels, Chief Executive Officer. |
|---|
| d. | The Company granted 100,000 ten-year options to purchase common stock with an exercise price of $0.47 per share which vest in one year to Peter Rodino, Chief Operating Officer and General Counsel. |
|---|
The Company recorded stock compensation expense of approximately $14,000 during the year ended December 31, 2023 with regard to these issuances to Officers Equels and Rodino.
(11)Leases
The Company leases office and lab facilities and other equipment under non-cancellable operating leases with initial terms typically ranging from 1 to 5 years, expiring at various dates during 2025 through 2027, and requiring monthly payments ranging from less than $1,000 to $17,000. Certain leases include additional renewal options ranging from 1 to 5 years. AIM has classified all of its leases as operating leases.
At December 31, 2024 and December 31, 2023, the balance of the right of use assets was $618,000 and $697,000, respectively, and the corresponding operating lease liability balance was $634,000 and $718,000, respectively. Right of use assets are recorded net of accumulated amortization of $428,000 and $363,000 as of December 31, 2024 and December 31, 2023, respectively.
AIM recognized rent expense associated with these leases are follows:
| Year ended December 31, | ||
|---|---|---|
| (in thousands) | ||
| 2024 | 2023 | |
| Lease costs: | ||
| Operating lease costs | $304 | $288 |
| Short-term and variable lease costs | 283 | 335 |
| Total lease costs | $587 | $623 |
| Classification of lease costs | ||
| Research & development | $446 | $498 |
| General and administrative | 141 | 125 |
| Total lease costs | $587 | $623 |
The Company’s leases have remaining lease terms between 3 and 31 months. At December 31, 2024, the weighted-average remaining term was 29 months. At December 31, 2023, the weighted-average remaining term was 41 months. The Company’s weighted average incremental borrowing rate for its leases was 10.3% at December 31, 2024 and 10% at December 31, 2023.
Future minimum payments as of December 31, 2024, are as follows:
| Year Ending December 31, (in thousands) | |
|---|---|
| 2025 | $293 |
| 2026 | 254 |
| 2027 | 159 |
| 2028 | — |
| Thereafter | — |
| Less imputed interest | (72) |
| Total | $634 |
(12) Income Taxes
The Company applies the provisions of FASB ASC 740-10 Uncertainty in Income Taxes. As a result of the implementation, there has been no material change to the Company’s tax positions as they have not paid any corporate income taxes due to operating losses. With the exception of net operating losses and research and development credits generated in New Jersey, all tax benefits will likely not be recognized due to the substantial net operating loss carryforwards which will most likely not be realized prior to expiration.
As of December 31, 2024, and December 31, 2023, respectively, the Company has approximately $117,194,000 of Federal net operating loss carryforwards (expiring in the years 2024 through 2038), and $103,300,000 of Federal net operating loss carryforwards with no expiration date, both of which have been limited by Internal Revenue Code Section 382, available to offset future federal taxable income. The Company has approximately $41,700,000 of New Jersey state net operating loss carryforwards (expiring in 2044). The Company has approximately $96,365,000 of Florida state net operating loss carryforwards with no expiration date to offset future Florida taxable income. The Company has approximately $3,600,000 of Belgium net operating loss carryforwards with no expiration date to offset future taxable income In December 2023, the Company effectively sold $14,156,000 of its New Jersey state net operating loss carryforward and $38,600 in R&D credits for the year 2022 for approximately $1,313,000. The company has fully utilized the maximum $20,000,000 allowance in proceeds received for the sale of New Jersey net operating loss carryforwards and R&D credits as of December 31, 2023. The utilization of certain state net operating loss carryforwards may be subject to annual limitations. With no tax due for the foreseeable future, the Company has determined that a policy to determine the accounting for interest or penalties related to the payment of tax is not necessary at this time.
Under the Tax Reform Act of 1986, the utilization of a corporation’s net operating loss carryforward is limited following a greater than 50% change in ownership. As noted above, due to the Company’s prior and current equity transactions, some of the Company’s net operating loss carryforwards are subject to an annual limitation generally determined by multiplying the value of the Company on the date of the ownership change by the federal long-term tax-exempt rate. Any unused annual limitation may be carried forward to future years for the balance of the net operating loss carryforward period. As of December 31, 2024, the tax years after 2020 remain subject to examination by major tax jurisdictions.
Deferred income taxes reflect the net tax effects of temporary differences between carrying amounts of assets and liabilities for financial reporting purposes and the carrying amounts used for income tax purposes. In assessing the realizability of deferred tax assets, Management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which temporary differences representing net future deductible amounts become deductible. With the exception of net operating losses generated in New Jersey which can be surrendered for 80% of their value, due to the uncertainty of the Company’s ability to realize the benefit of the deferred tax asset, the remainder of our deferred tax assets are fully offset by a valuation allowance at December 31, 2024 and 2023.
The components of the net deferred tax assets and liabilities as of December 31, 2024 and 2023, consist of the following:
| (in thousands) | ||
|---|---|---|
| Deferred tax assets: | December 31, | |
| 2024 | 2023 | |
| Net operating losses | $29,001 | $25,114 |
| Research and Development costs | 3,914 | 3,517 |
| Stock Compensation | 1,515 | 1,479 |
| R&D credits | 2,829 | 1,376 |
| Other | 41 | 137 |
| Amortization & Depreciation | 5,575 | 6,791 |
| Right of use asset | 4 | 6 |
| Total deferred tax assets | 42,879 | 38,420 |
| Less: Valuation allowance | (42,879) | (36,816) |
| Deferred tax assets, net | $— | $1,604 |
Deferred tax assets are included within other assets in the accompanying Consolidated Balance Sheets. The benefits of deferred tax assets are included within the gain from sale of income tax operating losses in the accompanying Consolidated Statements of Operations and Comprehensive Loss. The Company’s 2023 net deferred tax asset estimates the projected sale of 2023 New Jersey state operating losses to be sold in the subsequent year. After further analysis, it was determined that the New Jersey state operating loss sales proceeds reached the maximum $20 million allowed after the 2022 sale and a full valuation allowance was recorded in 2024 against all deferred tax assets.
Reconciliation between the effective tax rate on income from continuing operations and the statutory tax rate is as follows (in thousands):
| Pre Tax Book Loss | $(17,320) | |
| Federal Rate | (3,637) | 21.0% |
| State Taxes | (1,321) | 7.63% |
| Other Perms | 1 | -0.01% |
| RTP | 396 | -2.29% |
| Income Tax Income | 459 | -2.65% |
| State Rate Change | 149 | -0.86% |
| 162(m) | 126 | -0.73% |
| R&D credits | (969) | 5.59% |
| Mark to Market | (163) | 0.94% |
| R&D credit addback | 261 | -1.51% |
| Loss on Fair Value Warrants | 131 | -0.76% |
| Other | 108 | -0.62% |
| Valuation Allowance | 4,459 | -25.75% |
| Total | $— | -0.0% |
The Company files tax returns in the U.S., Florida and New Jersey. As of December 31, 2024, tax years for 2023, 2022, and 2021 are still subject to examination by the tax authorities. The Company is no longer subject to U.S. federal or state examinations by tax authorities for years before 2021.
(13) Certain Relationships and Related Transactions
The Company has an employment agreement with its NEOs and has granted its NEOs and directors options to purchase its common stock. Please see details of these Employment Agreements in Note 10 Employment/Consulting Agreements.
(14) Concentrations of Risk
Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash, cash equivalents and investments. The Company places its cash with high-quality financial institutions and, at times, such amounts in non-interest-bearing accounts may be in excess of Federal Deposit Insurance Corporation insurance limits. There were no credit-based sales for 2024 and 2023.
There are a limited number of suppliers in the United States and abroad available to provide the raw and packaging materials/reagents for use in manufacturing Ampligen and Alferon N Injection. At present, the Company does not have any agreements with third parties for the supply of any of these materials or it is relying on a limited source of reagent suppliers necessary for the manufacture of Alferon N Injection. Jubilant HollisterStier LLC has manufactured batches of Ampligen for us pursuant to purchase orders. The Company anticipates that additional orders will be placed upon approved quotes and purchase orders provided by us to Jubilant. On December 22, 2020, it added Pharmaceutics International Inc. (“Pii”) as a “Fill & Finish” provider to enhance our capacity to produce the drug Ampligen. This addition amplifies our manufacturing capability by providing redundancy and cost savings. The contracts augment the Company’s existing fill and finish capacity. If the Company is unable to place adequate acceptable purchase orders with Jubilant or Pii in the future at acceptable prices upon acceptable terms, it will need to find another manufacturer. The costs and availability of products and materials the Company would need for the production of Ampligen are subject to fluctuation depending on a variety of factors beyond our control, including competitive factors, changes in technology, ownership of intellectual property, FDA and other governmental regulations. There can be no assurance that the Company will be able to obtain such products and materials on terms acceptable to it or at all.
Currently, the Alferon N Injection manufacturing process is on hold and there is no definitive timetable to restart production. If the Company is unable to acquire FDA approvals related to the manufacturing process and/or final product of new Alferon N Injection inventory or contract with a CMO, its operations most likely will be materially and/or adversely affected. In light of these contingencies, there can be no assurances that the approved Alferon N Injection product will be returned to production on a timely basis, if at all, or that if and when it is again made commercially available, it will return to prior sales levels.
(15) Fair Value
The Company complies with the provisions of FASB ASC 820 “Fair Value Measurements” for its financial and non-financial assets and liabilities. ASC 820 defines fair value, establishes a framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis.
The fair values of cash and cash equivalents, other assets, accounts payable and accrued expenses approximate their carrying values due to the short-term maturities of these items and are considered a Level 1 instrument of the fair value measurements standard. The Company also has certain warrants with a cash settlement feature in the occurrence of a Fundamental Transaction. The fair value of the Class A and Class B warrants (“June 2024 Warrants”) related to the Company’s June 2024 common stock and warrant issuance, are calculated using a Monte Carlo Simulation. The fair value of the Class C and Class D warrants (“October 2024 Warrants”) related to the Company’s October 2024 common stock and warrant issuance, are calculated using a Monte Carlo Simulation.
The Company also had certain redeemable warrants in the Rights Offering with a cash settlement feature in the occurrence of a Fundamental Transaction. No Fundamental Transaction occurred. In March 2024,205,000 of these warrants converted on a cashless basis and 5,830,028 expired.
The Company estimated the fair value of the June 2024 Warrants using the Black-Scholes Model, which uses multiple inputs including the Company’s stock price, the exercise price of the warrant, volatility of the Company’s stock price, the risk-free interest rate and the expected term of the warrants.
The Company utilized the following assumptions to estimate the fair value of the Class A Warrants:
| December 31, | |
|---|---|
| Underlying price per share | $0.350 |
| Exercise price per share | $0.363 |
| Risk-free interest rate | 4.42% |
| Expected holding period | 5.5 years |
| Expected volatility | 110% |
| Expected dividend yield | — |
The Company utilized the following assumptions to estimate the fair value of the Class B Warrants:
| December 31, | |
|---|---|
| Underlying price per share | $0.350 |
| Exercise price per share | $0.363 |
| Risk-free interest rate | 4.82% |
| Expected holding period | 2 years |
| Expected volatility | 89% |
| Expected dividend yield | — |
The Company utilized the following assumptions to estimate the fair value of the Class C Warrants:
| December 31, | |
|---|---|
| Underlying price per share | $0.26 |
| Exercise price per share | $0.28 |
| Risk-free interest rate | 3.6% |
| Expected holding period | 2 years |
| Expected volatility | 82% |
| Expected dividend yield | — |
The Company utilized the following assumptions to estimate the fair value of the Class D Warrants:
| December 31, | |
|---|---|
| Underlying price per share | $0.26 |
| Exercise price per share | $0.28 |
| Risk-free interest rate | 3.5% |
| Expected holding period | 5.5 years |
| Expected volatility | 91% |
| Expected dividend yield | — |
The significant assumptions using the Monte Carlo Simulation approach for valuation of the Warrants are:
| (i) | Risk-Free Interest Rate. The risk-free interest rates for the Warrants are based on U.S. Treasury constant maturities for periods commensurate with the remaining expected holding periods of the warrants. |
| (ii) | Expected Holding Period. The expected holding period represents the period of time that the Warrants are expected to be outstanding until they are exercised. The Company utilizes the remaining contractual term of the Warrants at each valuation date as the expected holding period. |
| (iii) | Expected Volatility. Expected stock volatility is based on daily observations of the Company’s historical stock values for a period commensurate with the remaining expected holding period on the last day of the period for which the computation is made. |
| (iv) | Expected Dividend Yield. The expected dividend yield is based on the Company’s anticipated dividend payments over the remaining expected holding period. As the Company has never issued dividends, the expected dividend yield is 0% and this assumption will be continued in future calculations unless the Company changes its dividend policy. |
| (v) | Expected Probability of a Fundamental Transaction. Put rights arise if a Fundamental Transaction 1) is an all cash transaction; (2) results in the Company going private; or (3) is a transaction involving a person or entity not traded on a national securities exchange. The Company believes such an occurrence is unlikely because: |
| 1. | The Company only has one product that is FDA approved but is currently not available for commercial sales. |
| 2. | The Company will have to perform additional clinical trials for FDA approval of its flagship product. |
| 3. | Industry and market conditions continue to include uncertainty, adding risk to any transaction. |
| 4. | The nature of a life sciences company is heavily dependent on future funding and high fixed costs, including Research & Development. |
| 5. | The Company has minimal revenues streams which are insufficient to meet the funding needs for the cost of operations or construction at their manufacturing facility; and |
| 6. | The Company’s Rights Agreement and Executive Agreements make it less attractive to a potential buyer. |
With the above factors utilized in analysis of the likelihood of the Put’s potential Liability, the Company estimated the range of probabilities related to a Put right being triggered as:
| Range of Probability | Probability |
|---|---|
| Low | 0.5% |
| Medium | 1.0% |
| High | 5.0% |
The Monte Carlo Simulation has incorporated a 5.0% probability of a Fundamental Transaction to date for the life of the securities.
| (vi) | Expected Timing of Announcement of a Fundamental Transaction. As the Company has no specific expectation of a Fundamental Transaction, for reasons elucidated above, the Company utilized a discrete uniform probability distribution over the Expected Holding Period to model in the potential announcement of a Fundamental Transaction occurring during the Expected Holding Period. |
| (vii) | Expected 100 Day Volatility at Announcement of a Fundamental Transaction. An estimate of future volatility is necessary as there is no mechanism for directly measuring future stock price movements. Daily observations of the Company’s historical stock values for the 100 days immediately prior to the Warrants’ grant dates, with a floor of 100%, were utilized as a proxy for future volatility estimates. |
| (viii) | Expected Risk-Free Interest Rate at Announcement of a Fundamental Transaction. The Company utilized a risk-free interest rate corresponding to the forward U.S. Treasury rate for the period equal to the time between the date forecast for the public announcement of a Fundamental Transaction and the Warrant expiration date for each simulation. |
| (ix) | Expected Time Between Announcement and Consummation of a Fundamental Transaction. The expected time between the announcement and the consummation of a Fundamental Transaction is based on the Company’s experience with the due diligence process performed by acquirers and is estimated to be six months. The Monte Carlo Simulation approach incorporates this additional period to reflect the delay Warrant Holders would experience in receiving the proceeds of the Put. |
While the assumptions remain consistent from period to period (e.g., utilizing historical stock prices), the actual historical prices input for the relevant period input change.
The Company accounts for certain assets and liabilities at fair value. The hierarchy below lists three levels of fair value based on the extent to which inputs used in measuring fair value are observable in the market. AIM categorizes each of its fair value measurements in one of these three levels based on the lowest level input that is significant to the fair value measurement in its entirety. These levels are:
| 1. | Level 1 – Quoted prices are available in active markets for identical assets or liabilities at the reporting date. Generally, this includes debt and equity securities that are traded in an active market. |
| 2. | Level 2 – Observable inputs other than Level 1 prices such as quote prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Generally, this includes debt and equity securities that are not traded in an active market. |
| 3. | Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Level 3 assets and liabilities include financial instruments whose value is determined using pricing models, discounted cash flow methodologies, or other valuation techniques, as well as instruments for which the determination of fair value requires significant management judgment or estimation. As of December 31, 2024, the Company has classified the warrants with cash settlement features as Level 3. Management evaluates a variety of inputs and then estimates fair value based on those inputs. As discussed above, the Company utilized the Monte Carlo Simulation Model in valuing the warrants. |
The table below presents the balances of assets and liabilities measured at fair value on a recurring basis by level within the hierarchy as (in thousands):
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| Assets: | ||||
| Cash equivalents | $51 | $51 | $— | $— |
| Marketable securities | $2,276 | $2,276 | $— | $— |
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| Assets: | ||||
| Cash equivalents | $4,805 | $4,805 | $— | $— |
| Marketable securities | $7,631 | $7,631 | $— | $— |
(16) Contingencies
Because litigation is inherently unpredictable, assessing contingencies related to litigation is a complex process involving highly subjective judgment about potential outcomes of future events. When evaluating litigation contingencies, the Company may be unable to provide a meaningful estimate due to a number of factors, including the procedural status of the matter in question, the availability of appellate remedies, insurance coverage related to the claim or claims in question, the presence of complex or novel legal theories, and the ongoing discovery and development of information important to the matter. In addition, damage amounts claimed in litigation against the Company may be unsupported, exaggerated, or unrelated to possible outcomes, and as such are not meaningful indicators of the Company’s potential liability or financial exposure. Accordingly, the Company reviews the adequacy of accruals and disclosures each quarter in consultation with legal counsel, and it assesses the probability and range of possible losses associated with contingencies for potential accrual in the consolidated financial statements. However, the ultimate resolution of litigated claims may differ from the Company current estimates.
In the normal course of business, there are various claims in process, matters in litigation, and other contingencies, certain of which are covered by insurance policies. When a loss is probable, we record an accrual based on the reasonably estimable loss or range of loss. We do not record liabilities for reasonably possible loss contingencies but do disclose a range of reasonably possible losses if they are material and we are able to estimate such a range. If we cannot provide a range of reasonably possible losses, we explain the factors that prevent us from determining such a range. Historically, adjustments to our estimates have not been material. While it is not possible to predict the outcome of these suits, legal proceedings, and claims with certainty, management is of the opinion that adequate provision for potential losses associated with these matters has been made in the financial statements and that the ultimate resolution of any one of these matters will not have a material adverse effect on the Company’s financial position and results of operations. A significant increase in the number of these claims, or one or more successful claims resulting in greater liabilities than the Company currently anticipates, could materially and adversely affect the Company’s business, financial condition, results of operations, and cash flows.
(17) Segment and Related Information
The Company follows ASC 280,*Segment Reporting,*which establishes standards for the way public enterprises report information about operating segments in annual financial statements and requires that those enterprises report selected information about operating segments in financial statements issued to shareholders. The Company’s Chief Operating Decision Maker (“CODM”), its CEO, assesses performance and allocates resources based on company-wide financial information. The Company has determined that it operates in a single reportable segment and the strategic purpose of all operating activities is to support that one segment. The CODM does not generally evaluate the Company’s performance using asset or historical cash flow information. The measure of performance used by the CODM to evaluate the Company’s performance is consolidated net loss. Since the Company operates in one operating segment, which performs research and development activities related to Ampligen and other drugs under development, all required financial segment information can be found in the financial statements. Significant expenses that are used to evaluate performance are each separately presented in the statements of income. The Company does not distinguish between markets or segments for the purpose of internal reporting.
The Company’s revenues for the two-year period ended December 31, 2024, were earned in the United States. All assets are maintained in the United States of America.
(18) Subsequent Events
On February 26, 2025, the NYSE American accepted the Company’s plan to regain compliance with the minimum stockholders’ equity requirements of Sections 1003(a)(ii) and 1003(a)(iii) of the American Company Guide. AIM has until June 11, 2026 to regain compliance with the NYSE’s Continued Listings Standards. The plan includes a number of ways to raise capital. As Part of the Plan, the Company will be holding a special meeting of stockholders solely for the purpose of authorizing a reverse split of our outstanding shares. The proxy statement for that meeting has been filed with the SEC and is available on the SEC’s website. The Company believes that effecting a reverse split will assist it with raising capital it needs to continue its business and avoiding an automatic delisting if the stock price drops to $0.10 per share.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.