AIM ImmunoTech Inc. 10-Q

ITEM 1 : Financial Statements AIM IMMUNOTECH INC. AND SUBSIDIARIES Condensed Consolidated Balance Sheets (in thousands, except for share and per share amounts) (Unaudited September 30, 2024 and Audited December 31, 2023) September 30, 2024 December 31, 2023 ASSETS Current assets: Cash and cash equivalents $ 915 $ 5,439 Marketable securities 6,287 7,631 Funds receivable from New Jersey net operating loss — 1,184 Prepaid expenses and other current assets 368 302 Total current assets 7,570 14,556 Property and equipment, net 117 127 Right of use asset, net 653 697 Patent and trademark rights, net 2,532 2,313 Other assets 2,716 1,688 Total assets $ 13,588 $ 19,381 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 6,264 $ 6,443 Accrued expenses 1,011 1,986 Current portion of operating lease liability 232 223 Current portion of note payable, net 2,593 — Total current liabilities 10,100 8,652 Long-term liabilities: Operating lease liability 437 495 Note payable, net 139 — Total liabilities 10,676 9,147 Commitments and contingencies (Notes 13 and 14) - Stockholders’ equity: Series A Junior Participating Preferred Stock, $ 0.001 par value, 4,000,000 and 250,000 shares authorized as of September 30, 2024, and December 31, 2023, respectively: issued and outstanding – none — — Series B Convertible Preferred Stock, stated value $ 1,000 per share, 10,000 shares authorized; no issued and outstanding as of September 30, 2024 and 689 issued and outstanding as December 31, 2023 — 689 Convertible preferred stock, value — 689 Common Stock, $ 0.001 par value, authorized shares - 350,000,000 ; issued and outstanding shares 58,668,647 and 49,102,484 as of September 30, 2024 and December 31, 2023, respectively 59 49 Additional paid-in capital 423,714 419,004 Accumulated deficit ( 420,861 ) ( 409,508 ) Total stockholders’ equity 2,912 10,234 Total liabilities and stockholders’ equity $ 13,588 $ 19,381 See accompanying notes to consolidated financial statements. 2 AIM IMMUNOTECH INC. AND SUBSIDIARIES Consolidated Statements of Comprehensive Loss (in thousands, except share and per share data) (Unaudited) Three months ended September 30, Nine months ended September 30, 2024 2023 2024 2023 Revenues: Clinical treatment programs - US $ 35 $ 46 $ 125 $ 137 Total Revenues 35 46 125 137 Costs and Expenses: Production costs 8 30 24 30 Research and development 1,437 2,734 4,533 7,739 General and administrative 3,079 5,439 9,485 10,280 Total Costs and Expenses 4,524 8,203 14,042 18,049 Operating loss ( 4,489 ) ( 8,157 ) ( 13,917 ) ( 17,912 ) Gain (loss) on investments 273 ( 310 ) 96 ( 201 ) Interest and other income 718 294 3,379 811 Interest expense and other finance costs ( 202 ) — ( 453 ) — Gain on sale of fixed assets — 39 — 16 (Loss) on warrant issuance — — ( 458 ) — Gain from sale of income tax operating losses — 318 — 900 Net Loss $ ( 3,700 ) $ ( 7,816 ) $ ( 11,353 ) $ ( 16,386 ) Basic and diluted loss per share $ ( 0.06 ) $ ( 0.16 ) $ ( 0.21 ) $ ( 0.34 ) Weighted average shares outstanding basic and diluted 57,677,016 48,635,165 53,351,467 48,483,802 See accompanying notes to consolidated financial statements. 3 AIM IMMUNOTECH INC. AND SUBSIDIARIES Consolidated Statements of Changes in Stockholders’ Equity For the Nine Months Ended September 30, 2024 and 2023 (in thousands except share data) (Unaudited) Series B Preferred Shares Common Stock Shares Common Stock .001 Par Value Additional Paid-in Capital Accumulated other Comprehensive Income (Loss) Accumulated Deficit Total Stockholders’ Equity Balance December 31, 2023 $ 689 49,102,484 $ 49 $ 419,004 $ — $ ( 409,508 ) $ 10,234 Common stock issuance, net of costs — 807,577 1 328 — — 329 Cashless exercise of warrants — 3,272 — — — — — Equity-based compensation — — — 80 — — 80 Committed shares — 338,600 — — — — — Net comprehensive loss — — — — — ( 5,817 ) ( 5,817 ) Balance March 31, 2024 $ 689 50,251,933 $ 50 $ 419,412 $ — $ ( 415,325 ) $ 4,826 Common stock issuance, net of costs — 6,884,747 7 525 — — 532 Issuance of warrants — — — 2,500 — — 2,500 Equity-based compensation — — — 80 — — 80 Series B preferred shares expired ( 689 ) — — 689 — — — Net comprehensive loss — — — — — ( 1,836 ) ( 1,836 ) Balance June 30, 2024 $ — 57,136,680 $ 57 $ 423,206 $ — $ ( 417,161 ) $ 6,102 Common stock issuance, net of costs — 653,430 1 179 — — 180 Issuance of warrants — — — — — — — Equity-based compensation — 878,537 1 329 — — 330 Series B preferred shares expired — — — — — — — Net comprehensive loss — — — — — ( 3,700 ) ( 3,700 ) Balance September 30, 2024 $ — 58,668,647 $ 59 $ 423,714 $ — $ ( 420,861 ) $ 2,912 Series B Preferred Shares Common Stock Shares Common Stock .001 Par Value Additional Paid-in Capital Accumulated other Comprehensive Income (Loss) Accumulated Deficit Total Stockholders’ Equity Balance December 31, 2022 $ 696 48,084,287 $ 48 $ 418,270 $ — $ ( 380,546 ) $ 38,468 Common stock issuance, net of costs — 322,583 — 100 — — 100 Equity-based compensation — — — 82 — — 82 Series B preferred shares converted to common shares ( 4 ) 456 — 4 — — — Net comprehensive loss — — — — — ( 3,661 ) ( 3,661 ) Balance March 31, 2023 $ 692 48,407,326 $ 48 $ 418,456 — $ ( 384,207 ) $ 34,989 Common stock issuance, net of costs — 11,937 — 5 — — 5 Equity-based compensation — — — 50 — — 50 Series B preferred shares converted to common shares ( 2 ) 228 — 2 — — — Net Comprehensive loss — — — — — ( 4,909 ) ( 4,909 ) Balance June 30, 2023 $ 690 48,419,491 $ 48 $ 418,513 $ — $ ( 389,116 ) $ 30,135 Balance $ 690 48,419,491 $ 48 $ 418,513 $ — $ ( 389,116 ) $ 30,135 Common stock issuance, net of costs — 377,959 — 233 — — 233 Equity-based compensation — — — 50 — — 50 Series B preferred shares converted to common shares — — — — — — — Net Comprehensive loss — — — — — ( 7,816 ) ( 7,816 ) Balance September 30, 2023 $ 690 48,797,450 $ 48 $ 418,796 $ — $ ( 396,932 ) $ 22,602 Balance $ 690 48,797,450 $ 48 $ 418,796 $ — $ ( 396,932 ) $ 22,602 See accompanying notes to consolidated financial statements. 4 AIM IMMUNOTECH INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows For the Nine Months Ended September 30, 2024 and 2023 (in thousands) (Unaudited) 2024 2023 Cash flows from operating activities: Net loss $ ( 11,353 ) $ ( 16,386 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation of property and equipment 28 30 Abandonment of patent and trademark rights 46 14 Amortization of patent, trademark rights 154 150 Changes in right of use assets 226 151 Gain from sale of income tax operating losses — ( 900 ) Equity-based compensation 490 182 (Gain) loss on sale of marketable securities ( 95 ) 201 Loss on issuance of warrants 458 — Amortization of financial obligation 232 — Change in assets and liabilities: Other receivables — ( 9 ) Funds receivable from New Jersey net operating loss 1,181 1,676 Prepaid expenses and other current assets and other non-current assets ( 63 ) 192 Lease liability ( 231 ) ( 136 ) Other assets ( 1,028 ) — Accounts payable ( 179 ) 2,411 Accrued expenses ( 799 ) 915 Net cash used in operating activities ( 10,933 ) ( 11,509 ) Cash flows from investing activities: Proceeds from sale of marketable securities 1,597 924 Purchase of marketable securities ( 158 ) ( 1,155 ) (Purchase of) property and equipment ( 18 ) ( 10 ) Purchase of patent and trademark rights ( 419 ) ( 377 ) Net cash provided by (used in) investing activities 1,002 ( 618 ) Cash flows from financing activities: Proceeds from sale of stock, net of issuance costs 860 338 Proceeds from note payable, net of issuance costs 2,500 — Proceeds from issuance of equity warrants 2,047 — Net cash provided by financing activities 5,407 338 Net decrease in cash and cash equivalents ( 4,524 ) ( 11,789 ) Cash and cash equivalents at beginning of period 5,439 27,053 Cash and cash equivalents at end of period $ 915 $ 15,264 Supplemental disclosures of non-cash investing and financing cash flow information: Operating lease-Right of Use Assets $ ( 3 ) $ 49 Unrealized gain (loss) on marketable securities $ 373 $ ( 71 ) Conversion of Series B preferred $ — $ 6 Conversion of note payable interest into shares $ 175 $ — See accompanying notes to consolidated financial statements. 5 AIM IMMUNOTECH INC. AND SUBSIDIARIES NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS Note 1: 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. 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. 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. The interim consolidated financial statements and notes thereto are presented as permitted by the Securities and Exchange Commission (“SEC”), and do not contain certain information which will be included in the Company’s annual consolidated financial statements and notes thereto. These consolidated financial statements should be read in conjunction with the Company’s consolidated financial statements for the years ended December 31, 2023, and 2022, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on April 1, 2024. 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. 6 Liquidity and Going Concern The accompanying unaudited condensed 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 nine-month period ended September 30, 2024, and has a working capital deficit as of September 30, 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 unaudited condensed consolidated financial statements. Management evaluated the conditions, and the significance of these conditions related to the Company’s ability to meet its obligations and determined that the primary cause of the deficit was related to certain accounts payable which the Company is currently in negotiations with the vendor. These negotiations are ongoing and could result in significant amounts which could partially alleviate the negative working capital. There is no assurance as to the timing or outcome of these efforts. 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. Note 2 : 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 nine months ended September 30, 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. Note 3: Marketable Securities Marketable securities consist of mutual funds. At September 30, 2024 and December 31, 2023, it was determined that none of the marketable securities had an other-than-temporary impairment. At September 30, 2024 and December 31, 2023, all securities were measured as Level 1 instruments of the fair value measurements standard (See Note 12: Fair Value). At September 30, 2024, and December 31, 2023 the Company held $ 6,287,000 and $ 7,631,000 respectively, in mutual funds. Mutual Funds classified as available for sale consisted of $ 6,287,000 at September 30, 2024. The net gain recognized for the three-month period ended September 30, 2024 on equity securities was $273,000. The net losses recognized for the three-month period ended September 30, 2024 on equity securities sold during the period were ($59,000). The unrealized gains recognized for the three-month period ended September 30, 2024 on equity securities still held was $332,000. The net gain recognized for the nine-month period ended September 30, 2024 on equity securities was $96,000. The net losses recognized for the nine-month period ended September 30, 2024 on equity securities sold during the period were ($277,000). The unrealized gains recognized for the nine-month period ended September 30, 2024 on equity securities still held was $373,000. Mutual Funds classified as available for sale consisted of $ 7,631,000 at December 31, 2023. The net loss recognized for the three-month period ended September 30, 2023 on equity securities was ($309,000). The net losses recognized for the three-month period ended September 30, 2023 on equity securities sold during the period were ($42,000). The unrealized losses recognized during the three-month period ended September 30, 2023 on equity securities still held was ($267,000). The net losses recognized for the nine-month period ended September 30, 2023 on equity securities was ($201,000). The net losses recognized for the nine-month period ended September 30, 2023 on equity securities sold during the period were ($130,000). The unrealized losses recognized during the nine-month period ended September 30, 2023 on equity securities still held was ($71,000). 7 Note 4: Property and Equipment, net Schedule of Property and Equipment (in thousands) September 30, 2024 December 31, 2023 Furniture, fixtures, and equipment 1,466 1,448 Less: accumulated depreciation ( 1,349 ) ( 1,321 ) Property and equipment, net $ 117 $ 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 to ten years . Depreciation expense for the nine months ending September 30, 2024 and September 30, 2023 was $ 28,000 and $ 30,000 , respectively. Note 5: Patents, and Trademark Rights, Net Patent and trademark rights consist of the following (in thousands): Schedule of Patent and Trademark Rights September 30, 2024 December 31, 2023 Gross Carrying Value Accumulated Amortization Net Carrying Value Gross Carrying Value Accumulated Amortization Net Carrying Value Patents $ 3,315 $ ( 887 ) $ 2,428 $ 2,947 $ ( 750 ) $ 2,197 Trademarks 232 ( 128 ) 104 229 ( 113 ) 116 Net amortizable patents and trademarks rights $ 3,547 $ ( 1,015 ) $ 2,532 $ 3,176 $ ( 863 ) $ 2,313 Patent and trademark rights acquisitions, abandonments and amortization: Schedule of Changes in Patents, Trademark Rights December 31, 2023 $ 2,313 Acquisitions 419 Abandonments and expirations ( 46 ) Amortization ( 154 ) September 30, 2024 $ 2,532 8 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): Schedule of Amortization of Patents and Trademarks Year Ending December 31, 2024 $ 72 2025 268 2026 265 2027 239 2028 219 Thereafter 1,469 Total $ 2,532 Note 6: Accrued Expenses Accrued expenses consist of the following: Schedule of Accrued Expenses (in thousands) September 30, 2024 December 31, 2023 Compensation $ 1 $ 414 Professional fees 790 1,352 Clinical trial expenses 132 184 Interest 51 — Other expenses 37 36 Total $ 1,011 $ 1,986 Note 7: 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 was no debt at December 31, 2023. Schedule of Long Term Debt Debt schedule at September 30, 2024 (in thousands) Long-term debt $ 3,301 Unamortized Original issue discount ( 555 ) Unamortized Financing fees ( 14 ) Unamortized discount and debt issuance costs 2,732 Less current portion of long-term debt, net ( 2,593 ) Long-term debt, net $ 139 Interest expense related to long-term debt was $ 226,000 at September 30, 2024. Amortization expenses related to long-term debt was $ 232,000 at September 30, 2024. This consisted of $ 226,000 in original issue discount and $ 6,000 for loan fee amortization. Future maturities of long-term debt at September 30, 2024 were $ 750,000 for fiscal years ending December 31, 2024 and $ 2,551,000 for fiscal years ending December 31, 2025. (1) Current portion of long-term debt of approximately $3,000,000 is net of the current portion of debt discount of approximately $397,000 and the current portion of debt origination costs of approximately $10,000 as of September 30, 2024. (2) Long-term portion of debt of approximately $301,000 is net of the long-term portion of debt discount of approximately $159,000 and the unamortized debt origination costs of approximately $3,000 as of September 30, 2024. 9 Current portion of long-term debt of approximately $ 3,000,000 is net of the current portion of debt discount of approximately $ 397,000 and the current portion of debt origination costs of approximately $ 10,000 as of September 30, 2024. Long-term portion of debt of approximately $ 301,000 is net of the long-term portion of debt discount of approximately $ 159,000 and the unamortized debt origination costs of approximately $ 3,000 as of September 30, 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. Note 8: Equity-Based Compensation The 2018 Equity Incentive Plan, effective September 12, 2018, as amended and restated on August 19, 2019 (the “2018 Equity Incentive Plan”) 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. After taking into account the 44:1 reverse stock split which was effected in June 2019, initially, a maximum of 230,390 shares of common stock were reserved for potential issuance pursuant to awards under the 2018 Equity Incentive Plan. When the plan was amended and restated, an additional 250,000 shares were reserved for potential issuance pursuant to awards under the 2018 Equity Incentive Plan. The number of shares of the Company’s common stock available for grant and issuance under the 2018 Equity Incentive Plan is subject to an annual increase on July 1 of each calendar year, by an amount equal to two percent (2%) of the then outstanding shares of the Company’s common stock (the “2018 Plan Evergreen Provision”). On August 3, 2020, and July 1, 2021, 2022, 2023 and 2024, the number of shares of the Company’s common stock available for grant and issuance under the 2018 Equity Incentive Plan increased by 685,012 shares, 956,660 shares, 960,976 shares, 968,389 and 1,142,733 shares, respectively. As a result of the 2018 Plan Evergreen Provisions, a maximum of 5,167,160 shares of common stock is reserved for potential issuance pursuant to awards under the 2018 Equity Incentive Plan as of September 30, 2024. Unless sooner terminated, the 2018 Equity Incentive Plan will continue in effect for a period of 10 years from its effective date. During the fiscal year ended December 31, 2018, the Board of Directors issued 1,189,284 options to each employee, the officers and directors at the exercise price of $ 9.68 expiring in 10 years (27,028 options post reverse split) . During the fiscal year ending December 31, 2019, 1,727,756 options were issued to each of these officers with an exercise price of $ 9.68 for a period of ten years with a vesting period of one year (39,266 options post reverse split). During the fiscal year ending December 31, 2020, 1,025,000 options were issued to each of these officers and directors with an exercise price range of $ 2.77 to $ 3.07 for a period of ten years with a vesting period of one year. During the fiscal year ending December 31, 2021, 613,512 options were issued to officers, directors and consultants with an exercise price range of $ 1.11 to $ 1.71 for a period of ten years with a vesting period of one year. During the fiscal year ending December 31, 2022, 850,000 options were issued to officers, directors and consultants with an exercise price range of $ 0.31 to $ 0.71 for a period of ten years with a vesting period of one year. During the fiscal year ending December 31, 2023, 400,000 options were issued to officers with an exercise price of $ 0.47 for a period of ten years with a vesting period of one year. During the nine months ended September 30, 2024 there were no options issued. 10 The fair value of each option and equity warrant award is estimated on the date of grant using a Black-Scholes-Merton option pricing 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, expected life and forfeiture rates. During the nine months ended September 30, 2024, and 2023, there were no options granted. Stock options activity during the three months ended September 30, 2024, was as follows: Stock option activity for employees: Schedule of Stock Option Activity Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding June 30, 2024 2,407,775 $ 2.50 8.70 $ — Granted — — — — Forfeited — — — — Expired ( 95 ) — — — Outstanding September 30, 2024 2,407,680 $ 2.44 8.70 $ — Vested and expected to vest September 30, 2024 2,407,680 $ 2.44 8.70 $ — Exercisable September 30, 2024 2,341,014 $ 1.66 7.17 $ — Unvested stock option activity for employees: Schedule of Unvested Stock Option Activity Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Unvested June 30, 2024 166,666 $ 4.11 18.87 $ — Granted — — — — Expired ( 95 ) — — — Vested ( 99,905 ) 0.47 7.17 — Unvested September 30, 2024 66,666 $ 9.61 36.22 $ — 11 Stock option activity for non-employees: Schedule of Stock Option Activity Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding June 30, 2024 885,055 $ 2.02 9.23 $ — Granted — — — — Forfeited — — — — Expired ( 95 ) — — — Outstanding September 30, 2024 884,960 $ 1.88 9.23 $ — Vested and expected to vest September 30, 2024 884,960 $ 1.88 9.23 $ — Exercisable September 30, 2024 729,960 $ 1.87 10.06 $ — Unvested stock option activity for non-employees: Schedule of Unvested Stock Option Activity Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Unvested June 30, 2024 155,001 $ 3.42 11.30 $ — Granted — — — — Expired ( 95 ) — — — Vested 95 0.46 10.18 — Unvested September 30, 2024 155,001 $ 3.42 11.31 $ — Stock-based compensation expense was approximately $ 80,000 and $ 50,000 for the three months ended September 30, 2024, and 2023, resulting in an increase in general and administrative expenses, respectively. Employee stock option activity during the nine months ended September 30, 2024, was as follows: Stock option activity for employees: Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding January 1, 2024 2,408,438 $ 2.50 8.70 $ — Granted — — — — Forfeited — — — — Expired ( 758 ) — — — Outstanding September 30, 2024 2,407,680 $ 2.44 8.70 $ — Vested and expected to vest September 30, 2024 2,407,680 $ 2.44 8.70 $ — Exercisable September 30, 2024 2,341,014 $ 1.66 7.17 $ — 12 Unvested stock option activity for employees: Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Unvested January 1, 2024 366,666 $ 2.13 12.44 $ — Granted — — — — Expired ( 758 ) — — — Vested ( 299,242 ) 0.47 7.17 — Unvested September 30, 2024 66,666 $ 9.61 36.22 $ — Stock option activity for non-employees: Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding January 1, 2024 885,055 $ 2.02 9.23 $ — Granted — — — — Forfeited — — — — Expired ( 95 ) — — — Outstanding September 30, 2024 884,960 $ 1.88 9.23 $ — Vested and expected to vest September 30, 2024 884,960 $ 1.88 9.23 $ — Exercisable September 30, 2024 729,960 $ 1.87 10.06 $ — Unvested stock option activity for non-employees: Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Unvested January 1, 2024 335,001 $ 1.83 10.70 $ — Granted — — — — Expired ( 95 ) — — — Vested ( 179,905 ) 0.46 10.18 — Unvested September 30, 2024 155,001 $ 3.42 11.31 $ — Stock-based compensation expense was approximately $ 490,000 and $ 182,000 for the nine months ended September 30, 2024, and 2023, respectively. As part of the Company’s cash conservation strategy, the Company issued common stock as a substitute for cash salaries to certain executives. For the three and nine months ended September 30, 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 three and nine months ended September 30, 2023. On September 30, 2024, and 2023, respectively, there was approximately $ 53,400 and $ 35,000 of unrecognized equity-based compensation cost related to options granted under the Equity Incentive Plan. 13 Note 9: 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 September 30, 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 September 30, 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 September 30, 2024, and December 31, 2023, there were 58,668,647 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 October 21, 2024 and expires in December 2024. During the three months ended September 30, 2024, the Company did no t issue any shares of its common stock as part of the employee stock purchase plan. During the nine months ended September 30, 2024, the Company issued a total of 335,603 shares of its common stock at a price ranging from $ 0.33 to $ 0.41 for total proceeds of approximately $ 120,000 as part of the employee stock purchase plan. During the three months ended September 30, 2023, the Company issued a total of 62,841 shares of its common stock at a price ranging from $ 0.44 to $ 0.67 for total proceeds of approximately $ 35,500 as part of the employee stock purchase plan. During the nine months ended September 30, 2023, the Company issued a total of 385,424 shares of its common stock at a price ranging from $ 0.31 to $ 0.67 for total proceeds of approximately $ 135,000 as part of the employee stock purchase plan. 14 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 issued a 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 three months ended September 30, 2024, there were no warrants exercised and 15,000 warrants expired unexercised. During the nine months ended September 30, 2024, 205,000 warrants were exercised, and 5,830,028 warrants expired unexercised. As of September 30, 2024 there were no warrants outstanding and December 31, 2023 there were 152,160 post-split warrants outstanding, respectively. Equity Distribution Agreement On April 19, 2023, the Company entered into an Equity Distribution Agreement (the “EDA”) with Maxim Group LLC (“Maxim”), pursuant to which the Company may sell, from time to time, shares of its common stock having an aggregate offering price of up to $ 8,500,000 through Maxim, as agent (the “Offering”). Sales under the EDA were registered under the S-3 Shelf Registration Statement. Under the terms of the EDA, Maxim will be entitled to a transaction fee at a fixed rate of 3.0 % of the gross sales price of shares sold under the EDA. During the year ended December 31, 2023, the Company 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 . For the three months ended September 30, 2024, the Company sold 10,975 shares under the EDA for total gross proceeds of approximately $ 4,110 , which includes a 3.0 % fee to Maxim of $ 123 . For the nine months ended September 30, 2024, the Company sold 1,305,653 shares under the EDA for total gross proceeds of approximately $ 630,204 which includes a 3.0 % fee to Maxim of $ 18,906 . 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. There were no shares issued for the three months ended September 30, 2024. As of September 30, 2024, a total of 759,685 shares have been issued pursuant to the purchase agreement for a total of approximately $ 128,000 . 15 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 condensed consolidated financial statements. Proceeds allocated to such warrants totaled approximately $ 2.5 million. For the nine months ended September 30,2024, no Common Warrants were exercised, and all remain outstanding on September 30, 2024 related to this agreement. On September 30, 2024, the Company entered into a Securities Purchase Agreement to complete an offering with a single accredited investor. For more information see Note 15: Subsequent Events. 16 Note 10: Net Loss Per Share 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 stock options and warrants which amounted to 14,574,557 and 2,763,020 shares for the nine months ended September 30, 2024 and 2023, respectively, are excluded from the calculation of diluted net loss per share since their effect is anti-dilutive. Note 11: Recent Accounting Pronouncements The Company has implemented all new accounting pronouncements that are in effect. These pronouncements did not have any material impact on the financial statements unless otherwise disclosed, and the Company does not believe that there are any other new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations. Accounting pronouncements issued by the FASB since filing the Annual Report on Form 10-K for the year ended December 31, 2023 did not or are not believed by management to have a material impact on the Company’s present or future financial statements. Note 12: Fair Value 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 warrants (“June 2024 Warrants”) related to the Company’s June 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: Schedule of Assumptions to Estimate the Fair Value September 30, December 31, 2024 2023 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 — — 17 The Company utilized the following assumptions to estimate the fair value of the Class B Warrants: September 30, December 31, 2024 2023 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 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: Schedule of Potential Liability 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. 18 (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 September 30, 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): Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis As of September 30, 2024 Total Level 1 Level 2 Level 3 Assets: Cash equivalents $ 67 $ 67 $ — $ — Marketable securities $ 6,287 $ 6,287 $ — $ — As of December 31, 2023 Total Level 1 Level 2 Level 3 Assets: Cash equivalents $ 4,805 $ 4,805 $ — $ — Marketable securities $ 7,631 $ 7,631 $ — $ — Note 13: 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 2024 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 September 30, 2024 and December 31, 2023, the balance of the right of use assets was $ 653,000 and $ 697,000 , respectively, and the corresponding operating lease liability balance was $ 669,000 and $ 718,000 , respectively. Right of use assets are recorded net of accumulated amortization of $ 404,000 and $ 363,000 as of September 30, 2024 and December 31, 2023, respectively. 19 AIM recognized rent expense associated with these leases are follows: Schedule of AIM Recognized Rent Expense Associated with Operating Lease September 30, 2024 September 30, 2023 (in thousands) September 30, 2024 September 30, 2023 Lease costs: Operating lease costs $ 226 $ 214 Short-term and variable lease costs 205 253 Total lease costs $ 431 $ 467 Classification of lease costs Research & development $ 358 $ 400 General and administrative 73 67 Total lease costs $ 431 $ 467 The Company’s leases have remaining lease terms between 6 and 35 months. At September 30, 2024, the weighted-average remaining term was 32 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 10.2 % at September 30, 2024 and 10 % at December 31, 2023. Future minimum payments as of September 30, 2024, are as follows: Schedule of Operating Lease Future Payments Year Ending December 31, (in thousands) 2024 $ 78 2025 276 2026 244 2027 159 Thereafter — Less imputed interest ( 88 ) Total $ 669 Note 14: 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 three months ended September 30, 2024, research and development expenses were comprised of: clinical studies ($ 582,000 ), manufacturing and engineering ($ 306,000 ), quality control ($ 398,000 ) and regulatory ($ 151,000 ). During the three months ended September 30, 2023, research and development expenses were comprised of: clinical studies ($ 1,916,000 ), manufacturing and engineering ($ 396,000 ), quality control ($ 251,000 ) and regulatory ($ 170,000 ). During the nine months ended September 30, 2024, research and development expenses were comprised of: clinical studies ($ 1,880,000 ), manufacturing and engineering ($ 882,000 ), quality control ($ 1,232,000 ) and regulatory ($ 540,000 ). During the nine months ended September 30, 2023, research and development expenses were comprised of: clinical studies ($ 3,845,000 ), manufacturing and engineering ($ 2,783,000 ), quality control ($ 752,000 ) and regulatory ($ 359,000 ). 20 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 nine months ended September 30, 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 three months ended September 30, 2024 and 2023, the Company incurred approximately $ 275,400 and $ 516,284 , respectively, related to these ongoing agreements. During the nine months ended September 30, 2024 and 2023, the Company incurred approximately $ 881,987 and $ 1,294,265 , 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 three months ended September 30, 2024, the Company incurred approximately $ 129,000 related to this agreement. During the three months ended September 30, 2023, the Company incurred approximately $ 82,600 related to this agreement. ○ During the nine months ended September 30, 2024, the Company incurred approximately $ 141,100 related to this agreement. During the nine months ended September 30, 2023, the Company incurred approximately $ 350,600 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 three months ended September 30, 2024, the Company incurred approximately $ 27,500 related to this agreement. During the three months ended September 30, 2023, the Company incurred approximately $ 447,600 related to this agreement. ○ During the nine months ended September 30, 2024, the Company incurred approximately $ 195,800 related to this agreement. During the nine months ended September 30, 2023, the Company incurred approximately $ 783,400 related to this agreement. 21 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 three months ended September 30, 2024, the Company did no t incur any expense related to this agreement. During the three months ended September 30, 2023, the Company did no t incur any expense related to this agreement. ○ During the nine months ended September 30, 2024, the Company incurred approximately $ 1,200 related to this agreement. During the nine months ended September 30, 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 three months ended September 30, 2024, the Company incurred approximately $ 133,000 related to this agreement. During the three months ended September 30, 2023, the Company did no t incur any expense related to this agreement. ○ During the nine months ended September 30, 2024, the Company incurred approximately $ 261,600 related to this agreement. During the nine months ended September 30, 2023, the Company incurred approximately $ 357,000 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 three months ended September 30, 2024, the Company did no t incur any expense related to this agreement. During the three months ended September 30, 2023, the Company did no t incur any expense related to this agreement. ○ During the nine months ended September 30, 2024, the Company incurred approximately $ 79,000 related to this agreement. During the nine months ended September 30, 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 . ○ During the three months ended September 30, 2024, the Company incurred approximately $ 50,000 related to this agreement. During the three months ended September 30, 2023, the Company did no t incur any expense related to this agreement. ○ During the nine months ended September 30, 2024, the Company incurred approximately $ 230,000 related to this agreement. During the nine months ended September 30, 2023, the Company did no t incur any expense related to this agreement. 22 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 three months ended September 30, 2024, the Company did no t incur any expense for lab services from Alcami. During the three months ended September 30, 2023, the Company incurred approximately $ 8,800 of lab services from Alcami. ○ During the nine months ended September 30, 2024, the Company incurred approximately $ 14,000 of lab services from Alcami. During the nine months ended September 30, 2023, the Company incurred approximately $ 25,000 of lab services from Alcami. Note 15: Subsequent Events On September 30, 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 ”). The Transactions closed on October 1, 2024. Pursuant to the Purchase Agreement, at closing, the Company issued to the Purchaser, (i) in a registered direct offering, 4,653,036 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 C common warrants to purchase an aggregate of up to 4,653,036 shares of its Common Stock (the “ C Warrants ”) at an exercise price of $ 0.28 per share and Class D common warrants to purchase an aggregate of up to 4,653,036 shares of its Common Stock (the “ D Warrants ” and, along with the C Warrants, the “ Common Warrants ”) at an exercise price of $ 0.28 per share. The C Warrants and D Warrants will not be exercisable for six months after the issuance date and will 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 were offered pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the “ Securities Act ”), provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder. 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 the Company. The shares underlying the Common Warrants are being 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 cannot issue any equity securities for 60 days following the closing of the Transactions (the “ Closing Date ”), provided that the Company will be able to utilize it’s at-the-market offering (the “ ATM ”) 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 Closing 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 Date, 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 shares of Common Stock underling the Common Warrant (the “ Common Warrant Shares ”) will be 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 will be exercisable on a “cashless” basis only if there is not a current registration statement permitting public resale. In this regard, the Company has agreed to file a registration statement to register the resale of the Common Warrant Shares as soon as practicable (and in any event within 45 calendar days of the date of the Purchase Agreement) providing for the resale of the Shares issued and issuable upon exercise of the Common Warrants. The Company has agreed to use commercially reasonable efforts to cause such registration statement to become effective within 181 days following the Closing Date and to keep such registration statement effective at all times until no Purchaser owns any Common Warrants or Common Warrant Shares issuable upon exercise thereof. The Company is currently evaluating the Common Warrants under the guidance of ASC 480 – Distinguishing Liabilities from Equity 23