AIM ImmunoTech(AIM) - 2024 Q3 - Quarterly Report

FORM 10-Q Quarterly Report This report provides a comprehensive overview of AIM ImmunoTech Inc.'s financial performance, operational activities, and risk factors for the quarter ended September 30, 2024 Filer Information This section provides key administrative details of the quarterly report, including filing period, registrant identification, and company classification - Type of Report: Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934[1] - Period Ended: September 30, 2024[1] - Registrant: AIM IMMUNOTECH INC[1] - Filer Status: Smaller reporting company, Non-accelerated filer[2] - Common Stock Outstanding (as of Nov 11, 2024): 63,706,446 shares[2] PART I - FINANCIAL INFORMATION This part details the company's unaudited condensed consolidated financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures ITEM 1: Financial Statements This section presents the unaudited condensed consolidated financial statements and accompanying notes, highlighting financial position and performance Condensed Consolidated Balance Sheets This statement provides a snapshot of the company's assets, liabilities, and stockholders' equity at specific points in time | Metric | Sep 30, 2024 (in thousands) | Dec 31, 2023 (in thousands) | Change (in thousands) | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------- | | Cash and cash equivalents | $915 | $5,439 | ($4,524) | | Marketable securities | $6,287 | $7,631 | ($1,344) | | Total current assets | $7,570 | $14,556 | ($6,986) | | Total assets | $13,588 | $19,381 | ($5,793) | | Total current liabilities | $10,100 | $8,652 | $1,448 | | Total liabilities | $10,676 | $9,147 | $1,529 | | Total stockholders' equity | $2,912 | $10,234 | ($7,322) | Consolidated Statements of Comprehensive Loss This statement details the company's revenues, expenses, and net loss over specific reporting periods | Metric | Three months ended Sep 30, 2024 (in thousands) | Three months ended Sep 30, 2023 (in thousands) | Change (in thousands) | Change (%) | | :-------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :-------------------- | :--------- | | Total Revenues | $35 | $46 | ($11) | -23.9% | | Total Costs and Expenses | $4,524 | $8,203 | ($3,679) | -44.8% | | Operating loss | ($4,489) | ($8,157) | $3,668 | -45.0% | | Net Loss | ($3,700) | ($7,816) | $4,116 | -52.7% | | Basic and diluted loss per share | ($0.06) | ($0.16) | $0.10 | -62.5% | | Metric | Nine months ended Sep 30, 2024 (in thousands) | Nine months ended Sep 30, 2023 (in thousands) | Change (in thousands) | Change (%) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :-------------------- | :--------- | | Total Revenues | $125 | $137 | ($12) | -8.8% | | Total Costs and Expenses | $14,042 | $18,049 | ($4,007) | -22.2% | | Operating loss | ($13,917) | ($17,912) | $3,995 | -22.3% | | Net Loss | ($11,353) | ($16,386) | $5,033 | -30.7% | | Basic and diluted loss per share | ($0.21) | ($0.34) | $0.13 | -38.2% | Consolidated Statements of Changes in Stockholders' Equity This statement outlines the changes in the company's equity accounts over the reporting period | Metric | Dec 31, 2023 (in thousands) | Sep 30, 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------- | | Series B Preferred Shares | $689 | $0 | ($689) | | Common Stock Shares | 49,102,484 | 58,668,647 | 9,566,163 | | Common Stock Par Value | $49 | $59 | $10 | | Additional Paid-in Capital | $419,004 | $423,714 | $4,710 | | Accumulated Deficit | ($409,508) | ($420,861) | ($11,353) | | Total Stockholders' Equity | $10,234 | $2,912 | ($7,322) | - Net comprehensive loss for the nine months ended September 30, 2024, was ($11,353,000)[6] Consolidated Statements of Cash Flows This statement reports the cash generated and used by the company across operating, investing, and financing activities | Cash Flow Activity | Nine months ended Sep 30, 2024 (in thousands) | Nine months ended Sep 30, 2023 (in thousands) | Change (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :-------------------- | | Net cash used in operating activities | ($10,933) | ($11,509) | $576 | | Net cash provided by (used in) investing activities | $1,002 | ($618) | $1,620 | | Net cash provided by financing activities | $5,407 | $338 | $5,069 | | Net decrease in cash and cash equivalents | ($4,524) | ($11,789) | $7,265 | | Cash and cash equivalents at end of period | $915 | $15,264 | ($14,349) | - Proceeds from sale of stock, net of issuance costs, increased from $338,000 in 2023 to $860,000 in 2024[8] - Proceeds from note payable, net of issuance costs, were $2,500,000 in 2024, with no comparable amount in 2023[8] - Proceeds from issuance of equity warrants were $2,047,000 in 2024, with no comparable amount in 2023[8] Notes to Unaudited Condensed Consolidated Financial Statements These notes provide additional detail and context to the financial statements, explaining accounting policies and significant transactions Note 1: Business and Basis of Presentation This note describes the company's primary business activities, products, and the basis for financial statement preparation - AIM ImmunoTech Inc. is an immuno-pharma company focused on R&D of therapeutics for cancers, viral diseases, and immune-deficiency disorders[9] - Flagship products are Ampligen (rintatolimod) and Alferon N Injection (Interferon alfa)[10] - Ampligen is approved for commercial sale in the Argentine Republic for severe Chronic Fatigue Syndrome ("CFS") but not yet by the FDA in the United States[10] - Current primary focus areas for Ampligen include clinical trials for pancreatic cancer, evaluating it with checkpoint inhibitors for other cancers, exploring antiviral activities, and treating ME/CFS and Post-COVID conditions[10] - Clinical activities (pancreatic cancer, ME/CFS, Post-COVID) are prioritized over antiviral experimentation[11] Note 1: Liquidity and Going Concern This note addresses the company's ability to meet its short-term obligations and continue operations for the foreseeable future - Substantial doubt exists about the Company's ability to continue as a going concern for at least one year due to operating losses, net cash used in operations, a working capital deficit, and stockholders' equity below NYSE American minimum requirements[19] - The primary cause of the working capital deficit is related to a $6,300,000 accounts payable balance, including $4,900,000 in legal fees, which the Company is negotiating to reduce[266] - The Company is pursuing an additional $2.5 million in insurance recoveries under its secondary director and officer coverage, which, if received, could alleviate the negative working capital[268] Note 2: Cash and Cash Equivalents This note details the composition of cash and cash equivalents and associated credit risks | Metric | Sep 30, 2024 (in thousands) | Dec 31, 2023 (in thousands) | Change (in thousands) | | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------- | | Cash and cash equivalents | $915 | $5,439 | ($4,524) | - Cash includes bank deposits, some exceeding the federally insured limit of $250,000, but credit risk is considered minimal[20] Note 3: Marketable Securities This note provides information on the company's marketable securities, including fair value changes and investment gains or losses | Metric | Sep 30, 2024 (in thousands) | Dec 31, 2023 (in thousands) | Change (in thousands) | | :-------------------- | :-------------------------- | :-------------------------- | :-------------------- | | Marketable securities | $6,287 | $7,631 | ($1,344) | | Period | Net Gain (Loss) on Equity Securities (in thousands) | Unrealized Gains (Losses) on Held Equity Securities (in thousands) | | :-------------------------------- | :-------------------------------------------------- | :----------------------------------------------------------------- | | Three months ended Sep 30, 2024 | $273 | $332 | | Nine months ended Sep 30, 2024 | $96 | $373 | | Three months ended Sep 30, 2023 | ($309) | ($267) | | Nine months ended Sep 30, 2023 | ($201) | ($71) | Note 4: Property and Equipment, net This note outlines the company's property and equipment, net of accumulated depreciation | Metric | Sep 30, 2024 (in thousands) | Dec 31, 2023 (in thousands) | Change (in thousands) | | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------- | | Property and equipment, net | $117 | $127 | ($10) | - Depreciation expense for the nine months ended September 30, 2024, was $28,000[24] Note 5: Patents, and Trademark Rights, Net This note details the company's intangible assets related to patents and trademark rights, including amortization | Metric | Sep 30, 2024 (in thousands) | Dec 31, 2023 (in thousands) | Change (in thousands) | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------- | | Net amortizable patents and trademarks rights | $2,532 | $2,313 | $219 | - Acquisitions of patent and trademark rights totaled $419,000 for the nine months ended September 30, 2024[26] - Amortization expense for patent and trademark rights was $154,000 for the nine months ended September 30, 2024[26] Note 6: Accrued Expenses This note provides a breakdown of the company's accrued expenses by category | Accrued Expense Category | Sep 30, 2024 (in thousands) | Dec 31, 2023 (in thousands) | Change (in thousands) | | :----------------------- | :-------------------------- | :-------------------------- | :-------------------- | | Compensation | $1 | $414 | ($413) | | Professional fees | $790 | $1,352 | ($562) | | Clinical trial expenses | $132 | $184 | ($52) | | Interest | $51 | $0 | $51 | | Other expenses | $37 | $36 | $1 | | Total Accrued Expenses | $1,011 | $1,986 | ($975) | Note 7: Unsecured Promissory Note This note describes the terms and financial impact of the company's unsecured promissory note - Entered into an unsecured promissory note for $2,500,000 with Streeterville Capital LLC on February 16, 2024[30] - Total repayment amount is $3,301,250 by February 16, 2026, including principal, original issue discount ($781,250), and lender transaction fees ($20,000)[30] - Interest expense related to long-term debt was $226,000 for the nine months ended September 30, 2024[31] - Future maturities of long-term debt at September 30, 2024, are $750,000 for fiscal year 2024 and $2,551,000 for fiscal year 2025[31] Note 8: Equity-Based Compensation This note details the company's equity-based compensation plans and related expenses | Metric | Nine months ended Sep 30, 2024 (in thousands) | Nine months ended Sep 30, 2023 (in thousands) | Change (in thousands) | | :-------------------------- | :-------------------------------------------- | :-------------------------------------------- | :-------------------- | | Stock-based compensation expense | $490 | $182 | $308 | - No options were granted during the nine months ended September 30, 2024, or 2023[36] - As of September 30, 2024, a maximum of 5,167,160 shares of common stock are reserved for potential issuance under the 2018 Equity Incentive Plan[35] - Stock issued as payroll to certain executives totaled $250,000 for the three and nine months ended September 30, 2024[46] Note 9: Stockholders' Equity This note provides a detailed breakdown of changes in the company's stockholders' equity | Metric | Sep 30, 2024 | Dec 31, 2023 | Change | | :-------------------------------- | :----------- | :----------- | :------- | | Common Stock Issued and Outstanding | 58,668,647 | 49,102,484 | 9,566,163 | | Series B Convertible Preferred Stock Outstanding | 0 | 689 | (689) | - During the nine months ended September 30, 2024, 335,603 shares were issued under the Employee Stock Purchase Plan for approximately $120,000[56] - For the nine months ended September 30, 2024, the Company sold 1,305,653 shares under the Equity Distribution Agreement for total gross proceeds of approximately $630,204[61] - A Securities Purchase Agreement on May 31, 2024, issued 5,640,958 common shares and warrants, generating approximately $2,047,688 in gross proceeds[64][147] Note 10: Net Loss Per Share This note presents the calculation of basic and diluted net loss per share | Metric | Nine months ended Sep 30, 2024 | Nine months ended Sep 30, 2023 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Basic and diluted loss per share | ($0.21) | ($0.34) | | Weighted average shares outstanding | 53,351,467 | 48,483,802 | - Equivalent common shares (stock options and warrants) totaling 14,574,557 for the nine months ended September 30, 2024, were excluded from diluted EPS calculation as they were anti-dilutive[72] Note 11: Recent Accounting Pronouncements This note discusses the impact of recently adopted and issued accounting pronouncements - All new accounting pronouncements in effect have been implemented, with no material impact on financial statements[73] - Management does not believe any other new accounting pronouncements will have a material impact on future financial statements[73] Note 12: Fair Value This note provides information on the fair value measurements of financial instruments - Cash and cash equivalents ($67,000) and marketable securities ($6,287,000) are classified as Level 1 instruments at September 30, 2024[85] - Warrants with cash settlement features are classified as Level 3 instruments and valued using a Monte Carlo Simulation[84] - Key assumptions for warrant valuation include a 5.0% probability of a Fundamental Transaction[80] Note 13: Leases This note details the company's lease arrangements, including right-of-use assets and lease liabilities | Metric | Sep 30, 2024 (in thousands) | Dec 31, 2023 (in thousands) | | :-------------------- | :-------------------------- | :-------------------------- | | Right of use assets | $653 | $697 | | Operating lease liability | $669 | $718 | | Lease Cost Category | Nine months ended Sep 30, 2024 (in thousands) | Nine months ended Sep 30, 2023 (in thousands) | | :-------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Operating lease costs | $226 | $214 | | Short-term and variable lease costs | $205 | $253 | | Total lease costs | $431 | $467 | | Research & development | $358 | $400 | | General and administrative | $73 | $67 | - Weighted-average remaining lease term was 32 months at September 30, 2024, with a weighted average incremental borrowing rate of 10.2%[88] Note 14: Research, Consulting and Supply Agreements This note outlines the company's significant agreements related to research, consulting, and supply | R&D Expense Category | Nine months ended Sep 30, 2024 (in thousands) | Nine months ended Sep 30, 2023 (in thousands) | Change (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :-------------------- | | Clinical studies | $1,880 | $3,845 | ($1,965) | | Manufacturing and engineering | $882 | $2,783 | ($1,901) | | Quality control | $1,232 | $752 | $480 | | Regulatory | $540 | $359 | $181 | | Total R&D expenses | $4,533 | $7,739 | ($3,206) | - Incurred $881,987 with Amarex Clinical Research LLC for ongoing agreements during the nine months ended September 30, 2024, down from $1,294,265 in 2023[95] - Incurred $1,200 with Jubilant HollisterStier for Ampligen manufacturing during the nine months ended September 30, 2024, a significant decrease from $1,432,000 in 2023[101] - Incurred $261,600 with Sterling Pharma Solutions for polynucleotide manufacturing during the nine months ended September 30, 2024, down from $357,000 in 2023[103] Note 15: Subsequent Events This note discloses significant events that occurred after the balance sheet date but before the financial statements were issued - On September 30, 2024, entered into a Securities Purchase Agreement, closing on October 1, 2024[110] - Issued 4,653,036 common shares and Class C and D common warrants to a single accredited investor[110] - Received aggregate gross proceeds of approximately $1.26 million from the transaction[111] - Warrants are not exercisable for six months; Class C expires in 24 months, Class D in five years and six months[110] ITEM 2: Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition, operational results, and future outlook Special Note Regarding Forward-Looking Statements This section cautions readers about forward-looking statements and the inherent risks and uncertainties involved - Report contains forward-looking statements about strategy, future operations, financial position, revenues, costs, plans, prospects, and objectives[115] - Forward-looking statements are not guarantees of performance and actual results may vary due to risks and uncertainties[115] - Significant additional testing and trials are required for Ampligen's effectiveness, and success is not assured[115] - The company disclaims any obligation to update forward-looking statements[117] General Overview This section provides a high-level summary of the company's business, products, and strategic focus - AIM ImmunoTech Inc. is an immuno-pharma company focused on R&D of therapeutics for cancers, viral diseases, and immune-deficiency disorders[120] - Flagship products are Ampligen (rintatolimod) and Alferon N Injection (Interferon alfa)[121] - Ampligen is being developed for pancreatic cancer, other cancers (with checkpoint inhibitors), antiviral activities, and ME/CFS/Post-COVID conditions[121] - Clinical activities for pancreatic cancer, ME/CFS, and Post-COVID conditions are prioritized over antiviral experimentation[122] Immuno-Oncology This section details the company's development efforts and clinical trials for Ampligen in immuno-oncology - Initial focus for pancreatic cancer is on locally advanced cases due to trial scale differences[126] - Phase 2 AMP-270 clinical trial for locally advanced pancreatic cancer is recruiting patients in the U.S. and Europe[164] - DURIPANC Study (Phase 1b/2) combines Ampligen with AstraZeneca's durvalumab for late-stage pancreatic cancer, showing stable disease in some subjects[165] - A Phase 2 study in advanced recurrent ovarian cancer using cisplatin, pembrolizumab, plus Ampligen reported an Objective Response Rate (ORR) of 45% and a Clinical Benefit Rate (CBR) of 55% in platinum-sensitive subjects[166] - Netherlands Patent Office granted a patent for Ampligen as a combination cancer therapy with checkpoint blockade inhibitors[166] - Positive data from Erasmus MC published in Clinical Cancer Research in March 2024, titled "Rintatolimod in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated T Cell Responses"[176] Ampligen as a Potential Antiviral This section discusses Ampligen's antiviral properties and its potential applications against viral diseases - Ampligen showed excellent antiviral properties and protective survival effects in NIH-contracted studies of SARS-CoV-1-infected mice[186][187] - Utah State University research showed Ampligen decreased SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal dosage levels[193] - A Phase 1 randomized, double-blind study in the Netherlands evaluating intranasal Ampligen in healthy subjects reported no Serious or Severe Adverse Events at any dosage level[195] - Provisional patent applications filed for Ampligen as a coronavirus therapy, as part of an intranasal universal coronavirus vaccine, and for a high-volume manufacturing process[190] Ampligen as a Treatment for Post-COVID Conditions This section outlines clinical studies and findings regarding Ampligen's efficacy in treating Post-COVID conditions - Phase 2 AMP-518 study for Post-COVID conditions (fatigue) completed enrollment of 80 subjects and treatment[198] - Analysis of complete clinical patient data in September 2024 supported Ampligen's potential for moderate-to-severe Post-COVID fatigue[198] - Subjects with baseline 6MWT less than 205 meters showed a mean improvement of 139 meters with Ampligen, compared to 91 meters with placebo (p <0.02)[198] Ampligen as a treatment for ME/CFS and Post-COVID Conditions This section covers Ampligen's use and development for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and Post-COVID conditions - Ampligen is approved for commercial sale in Argentina for severe CFS, with the commercial launch process ongoing[134][206] - The AMP-511 Expanded Access Program for ME/CFS patients has been expanded to include Post-COVID conditions[135][203] - Preliminary results from AMP-511 in Post-COVID patients showed a clinically significant decrease in fatigue-related measures by week 12[135] - Data published in PLOS ONE in November 2020 indicated Ampligen substantially improved physical performance in a subset of ME/CFS patients[204] Atlas Equity Line of Credit This section describes the company's equity line of credit agreement with Atlas Sciences, LLC for capital raising - Entered into an Equity Purchase Agreement with Atlas Sciences, LLC on March 28, 2024, for up to $15 million of common stock over 24 months[136] - As of September 30, 2024, 759,685 shares have been issued under this agreement for approximately $128,000[63][275] - Sales are at the company's sole discretion, subject to daily maximums (lesser of $500,000, Median Daily Trading volume) and beneficial ownership limitations[63][137][275] - An initial commitment fee of 338,600 common shares was paid to Atlas[142] Securities Purchase Agreement (May 31, 2024) This section details the terms and proceeds from the securities purchase agreement executed on May 31, 2024 - On May 31, 2024, issued 5,640,958 common shares and Class A and B common warrants to a single accredited investor[146][276] - Received aggregate gross proceeds of approximately $2,047,688[147][277] - Warrants are not exercisable for six months; Class A expires in 24 months, Class B in five years and six months[146][276] - Maxim Group LLC received an 8% cash fee as placement agent[150][280] OUR PRODUCTS This section provides an overview of the company's key pharmaceutical products and their development status Ampligen (rintatolimod) This section describes Ampligen, its mechanism of action, approved uses, and ongoing clinical development - Ampligen is a first-in-class large macromolecular double-stranded RNA (dsRNA) molecule[152][154] - Approved for sale in Argentina (to 2026) for severe CFS; experimental drug in the US for cancers, ME/CFS, and Post-COVID Conditions[153] - Received Orphan Drug Product Designation from FDA and EMA for pancreatic cancer[178][179] - Received Orphan Drug Designation from FDA for the treatment of Ebola virus disease in November 2022[211] - US patent No. 12,102,649 granted in October 2024, covering compositions and methods comprising Ampligen in the treatment of endometriosis[212] Alferon N Injection® This section details Alferon N Injection, its approved uses, and current production status - Alferon N Injection is the only natural-source, multi-species alpha interferon approved for sale in the United States and Argentina for refractory/recurring external genital warts[213] - Production of new Alferon N Injection Active Pharmaceutical Ingredient (API) is currently on hold, with no definitive timetable to resume[216] - U.S. Patent granted in May 2023 for a method using alpha-interferon to prevent or reduce antigenic drift or viral reassortment in host animals exposed to avian influenza virus[216] MANUFACTURING This section outlines the company's manufacturing processes and contract manufacturing organizations for its products - Jubilant HollisterStier is the authorized CMO for Ampligen, manufacturing additional lots in December 2023[100][218] - Sterling Pharma Solutions manufactures Poly I and Poly C12U polynucleotides, precursors for Ampligen[102][222] - Pharmaceutics International Inc. (Pii) was added as a "Fill & Finish" provider to enhance Ampligen production capacity[161][219] - Production of Alferon N Injection is currently on hold, with no definitive timetable to resume[223] LICENSING/COLLABORATIONS/JOINT VENTURES This section describes the company's strategy for licensing, collaborations, and joint ventures to advance product development - Strategy is to license Ampligen and/or collaborate/joint venture with global partners for regulatory approval and commercialization[224] - Ideal partners possess global/regional experience, commercial infrastructure, successful development/registration track record, and therapeutic area fit (ME/CFS, immuno-oncology)[224] MARKETING/DISTRIBUTION This section details the company's marketing and distribution agreements for its products in various regions - Exclusive agreement with GP Pharm for Ampligen in Argentina, extended until May 2024, with ongoing discussions for further extension[225] - MyTomorrows manages Early Access Programs (EAPs) for Ampligen in Europe, Canada, and Turkey for ME/CFS and pancreatic cancer, with the agreement automatically extending annually[159][226][228][230] - Commercial sales of Alferon N Injection in the United States will not resume until new batches are produced and released by the FDA[223] 401(k) Plan This section provides information on the company's 401(k) retirement plan for employees - Full-time employees are eligible for the 401(k) Plan after 61 days of employment[232] - A 6% safe harbor matching contribution was reinstated effective January 1, 2021[233] - Company contributions for the nine months ended September 30, 2024, were approximately $134,200[233] New Accounting Pronouncements This section refers to the impact of new accounting pronouncements on the financial statements - Refer to Note 10 for details on recent accounting pronouncements[234] Critical Accounting Policies and Use of Estimates This section discusses the significant accounting policies and estimates that require management judgment - No material changes to critical accounting policies and estimates, except for "Distinguishing Liabilities from Equity" and "Derivative Instruments"[235] Distinguishing Liabilities from Equity This section explains the accounting policies for classifying financial instruments as liabilities or equity - Adopted ASC 480 guidance for classifying and measuring financial instruments with liability and equity characteristics[236] - Evaluation includes determining if instruments are mandatorily redeemable, involve asset transfer upon redemption, or have conditional redemption features[236] Derivative Instruments This section outlines the accounting treatment for derivative financial instruments - Evaluates financial instruments for derivative features or embedded derivatives under ASC Topic 815[237] - Derivative instruments are measured at fair value at issuance and each reporting date, with changes recognized in comprehensive loss[237] RESULTS OF OPERATIONS This section analyzes the company's financial performance, including revenues, expenses, and net loss Three months ended September 30, 2024 versus three months ended September 30, 2023 This section compares the company's financial results for the three-month periods ended September 30, 2024 and 2023 Net Loss This section analyzes the net loss and loss per share for the three-month period | Metric | Three months ended Sep 30, 2024 (in thousands) | Three months ended Sep 30, 2023 (in thousands) | Change (in thousands) | Change (%) | | :-------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :-------------------- | :--------- | | Net Loss | ($3,700) | ($7,816) | $4,116 | -52.7% | | Basic and diluted loss per share | ($0.06) | ($0.16) | $0.10 | -62.5% | - Decrease in R&D expenses of $1,297,000 and G&A expenses of $2,360,000[238] - Increase in gain on investments of $583,000 and interest and other income of $424,000[238] Revenues This section details the company's revenues for the three-month period, primarily from Ampligen cost recovery | Metric | Three months ended Sep 30, 2024 (in thousands) | Three months ended Sep 30, 2023 (in thousands) | Change (in thousands) | Change (%) | | :-------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :-------------------- | :--------- | | Revenues from Ampligen Cost Recovery Program | $35 | $46 | ($11) | -23.9% | - No Alferon N Injection Finished Good product was commercially sold during these periods[241] Interest and Other Income This section examines interest and other income for the three-month period, including reclassified fees | Metric | Three months ended Sep 30, 2024 (in thousands) | Three months ended Sep 30, 2023 (in thousands) | Change (in thousands) | Change (%) | | :-------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :-------------------- | :--------- | | Interest and other income | $718 | $294 | $424 | 144.2% | - Increase primarily due to a $657,300 increase in other income from reclassification of an Amarex execution fee to a refundable deposit[242] Gain (loss) on Investments, net This section analyzes the net gain or loss from investments for the three-month period | Metric | Three months ended Sep 30, 2024 (in thousands) | Three months ended Sep 30, 2023 (in thousands) | Change (in thousands) | | :-------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :-------------------- | | Gain (loss) on investments | $273 | ($310) | $583 | - Increase in gain due to change in fair value of equity investments[243] Production Costs This section details the production costs incurred during the three-month period | Metric | Three months ended Sep 30, 2024 (in thousands) | Three months ended Sep 30, 2023 (in thousands) | Change (in thousands) | Change (%) | | :-------------------- | :--------------------------------------------- | :--------------------------------------------- | :-------------------- | :--------- | | Production costs | $8 | $30 | ($22) | -73.3% | Gain (loss) from sale of income tax operating loss This section reports the gain or loss from the sale of income tax operating losses for the three-month period | Metric | Three months ended Sep 30, 2024 (in thousands) | Three months ended Sep 30, 2023 (in thousands) | Change (in thousands) | | :-------------------------------- | :--------------------------------------------- | :--------------------------------------------- | :-------------------- | | Gain from sale of income tax operating losses | $0 | $318 | ($318) | - Lifetime limit of $20,000,000 for the sale of New Jersey NOLs was reached, resulting in no tax provision in 2024[245] Research and Development Costs This section analyzes the research and development expenses for the three-month period | Metric | Three months ended Sep 30, 2024 (in thousands) | Three months ended Sep 30, 2023 (in thousands) | Change (in thousands) | Change (%) | | :-------------------- | :--------------------------------------------- | :--------------------------------------------- | :-------------------- | :--------- | | R&D costs | $1,437 | $2,734 | ($1,297) | -47.4% | - Primary decrease in clinical expenses ($1,384,000) and outside contractors ($20,000)[246] - Offset by increases in patent and trademark expenses ($44,000), salaries ($18,000), rent ($16,000), computer & information services ($16,000), and consultant fees ($13,000)[246] General and Administrative Expenses This section details the general and administrative expenses for the three-month period | Metric | Three months ended Sep 30, 2024 (in thousands) | Three months ended Sep 30, 2023 (in thousands) | Change (in thousands) | Change (%) | | :-------------------- | :--------------------------------------------- | :--------------------------------------------- | :-------------------- | :--------- | | G&A expenses | $3,079 | $5,439 | ($2,360) | -43.4% | - Primary decrease in professional fees ($2,395,000) and public relation expenses ($138,000)[247] - Offset by increases in stock compensation ($280,000) and license and taxes ($44,000)[247] Interest Expenses This section reports the interest expenses incurred during the three-month period | Metric | Three months ended Sep 30, 2024 (in thousands) | Three months ended Sep 30, 2023 (in thousands) | Change (in thousands) | | :-------------------- | :--------------------------------------------- | :--------------------------------------------- | :-------------------- | | Interest expenses | $202 | $0 | $202 | - Increase due to interest incurred from the Note Purchase Agreement entered into on February 16, 2024[248] Nine months ended September 30, 2024 versus nine months ended September 30, 2023 This section compares the company's financial results for the nine-month periods ended September 30, 2024 and 2023 Net Loss This section analyzes the net loss and loss per share for the nine-month period | Metric | Nine months ended Sep 30, 2024 (in thousands) | Nine months ended Sep 30, 2023 (in thousands) | Change (in thousands) | Change (%) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :-------------------- | :--------- | | Net Loss | ($11,353) | ($16,386) | $5,033 | -30.7% | | Basic and diluted loss per share | ($0.21) | ($0.34) | $0.13 | -38.2% | - Decrease in R&D expenses of $3,206,000 and G&A expenses of $795,000[249] - Increase in gain on investments of $297,000 and interest and other income of $2,568,000[249] Revenues This section details the company's revenues for the nine-month period, primarily from Ampligen cost recovery | Metric | Nine months ended Sep 30, 2024 (in thousands) | Nine months ended Sep 30, 2023 (in thousands) | Change (in thousands) | Change (%) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :-------------------- | :--------- | | Revenues from Ampligen Cost Recovery Program | $125 | $137 | ($12) | -8.8% | - No Alferon N Injection Finished Good product was commercially sold during these periods[252] Interest and Other Income This section examines interest and other income for the nine-month period, including insurance recoveries | Metric | Nine months ended Sep 30, 2024 (in thousands) | Nine months ended Sep 30, 2023 (in thousands) | Change (in thousands) | Change (%) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :-------------------- | :--------- | | Interest and other income | $3,379 | $811 | $2,568 | 316.6% | - Increase primarily due to $2,500,000 recovery from D&O insurance proceeds and reclassification of Amarex execution fee[253] Gain (loss) on Investments, net This section analyzes the net gain or loss from investments for the nine-month period | Metric | Nine months ended Sep 30, 2024 (in thousands) | Nine months ended Sep 30, 2023 (in thousands) | Change (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :-------------------- | | Gain (loss) on investments | $96 | ($201) | $297 | - Increase in gain due to change in fair value of equity investments[254] Production Costs This section details the production costs incurred during the nine-month period | Metric | Nine months ended Sep 30, 2024 (in thousands) | Nine months ended Sep 30, 2023 (in thousands) | Change (in thousands) | Change (%) | | :-------------------- | :-------------------------------------------- | :-------------------------------------------- | :-------------------- | :--------- | | Production costs | $24 | $30 | ($6) | -20.0% | Gain (loss) from sale of income tax operating loss This section reports the gain or loss from the sale of income tax operating losses for the nine-month period | Metric | Nine months ended Sep 30, 2024 (in thousands) | Nine months ended Sep 30, 2023 (in thousands) | Change (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :-------------------- | | Gain from sale of income tax operating losses | $0 | $900 | ($900) | - Lifetime limit of $20,000,000 for the sale of New Jersey NOLs was reached, resulting in no tax provision in 2024[256] Research and Development Costs This section analyzes the research and development expenses for the nine-month period | Metric | Nine months ended Sep 30, 2024 (in thousands) | Nine months ended Sep 30, 2023 (in thousands) | Change (in thousands) | Change (%) | | :-------------------- | :-------------------------------------------- | :-------------------------------------------- | :-------------------- | :--------- | | R&D costs | $4,533 | $7,739 | ($3,206) | -41.4% | - Primary decrease in outside contractors ($1,770,000) and clinical expenses ($1,738,000)[257] - Offset by increases in salaries ($270,000), patent and trademark expenses ($34,000), rent ($30,000), consulting fees ($27,000), manufacturing expenses ($24,000), insurance ($18,000), and maintenance ($17,000)[257] General and Administrative Expenses This section details the general and administrative expenses for the nine-month period | Metric | Nine months ended Sep 30, 2024 (in thousands) | Nine months ended Sep 30, 2023 (in thousands) | Change (in thousands) | Change (%) | | :-------------------- | :-------------------------------------------- | :-------------------------------------------- | :-------------------- | :--------- | | G&A expenses | $9,485 | $10,280 | ($795) | -7.7% | - Primary decrease in legal professional fees ($968,000) and insurance expense ($208,000)[258] - Offset by increases in investment banker fees ($314,000) and stock compensation ($308,000)[258] Interest Expenses This section reports the interest expenses incurred during the nine-month period | Metric | Nine months ended Sep 30, 2024 (in thousands) | Nine months ended Sep 30, 2023 (in thousands) | Change (in thousands) | | :-------------------- | :-------------------------------------------- | :-------------------------------------------- | :-------------------- | | Interest expenses | $453 | $0 | $453 | - Increase due to interest incurred from the Note Purchase Agreement entered into on February 16, 2024[259] Liquidity and Capital Resources This section discusses the company's cash flows, working capital, and strategies for managing liquidity and capital - Cash used in operating activities decreased by $576,000 to $10,933,000 for the nine months ended September 30, 2024[261] - Cash provided by investing activities was $1,002,000, a change of $1,620,000 from cash used in 2023[262] - Cash provided by financing activities increased by $5,069,000 to $5,407,000, driven by notes payable, stock sales, and warrant issuances[263] - As of September 30, 2024, current liabilities exceeded current assets by $2,530,000, and stockholders' equity was $2,912,000, below NYSE American minimum requirements[265] - Management is negotiating a $4,900,000 legal fees component of accounts payable and pursuing an additional $2.5 million in D&O insurance recoveries to alleviate liquidity concerns[266][268] - The company has an ATM offering (expires April 19, 2025) and an equity line of credit with Atlas Sciences, LLC (up to $15 million) as capital mechanisms[269][270] NYSE American Continued Listing Requirements This section addresses the company's compliance with NYSE American listing requirements and potential implications - Required to maintain Stockholders' Equity of $6,000,000 for NYSE American listing[284] - Stockholders' Equity was $2,912,000 at September 30, 2024[4][284] - Taking into account funds received after September 30, 2024, Stockholders' Equity is $4,291,888, still below the minimum requirement[284] - Delisting could reduce liquidity and market price of common stock, limit ability to raise equity financing, and impair employee equity incentives[285] ITEM 3: Quantitative and Qualitative Disclosures About Market Risk This section states the company's exemption from providing market risk disclosures as a smaller reporting company - As a smaller reporting company, the registrant is not required to provide information on market risk[286] ITEM 4: Controls and Procedures This section reports on the effectiveness of disclosure controls and internal controls over financial reporting - CEO and CFO concluded disclosure controls and procedures were effective as of September 30, 2023[287] - No material changes in internal controls over financial reporting occurred during the nine months ended September 30, 2024[288] Part II – OTHER INFORMATION This part includes legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits ITEM 1: Legal Proceedings This section details the company's ongoing legal proceedings, including appeals and court decisions - Judgments totaling $293,409 were entered against AIM in AIM ImmunoTech, Inc. v. Tudor, et al. for attorney's fees and costs, which AIM has appealed[290][291] - In Kellner v. AIM ImmunoTech Inc. et al., the Delaware Supreme Court ruled certain bylaws invalid but also noted deceptive conduct by Kellner and his nominees[292] - Kellner's motion for reargument and request for fee reimbursement in the Kellner litigation were denied by the Supreme Court[292] - In BioLife, counterclaims were dismissed without prejudice to allow the Superior Court to consider appeal issues[293] ITEM 1A: Risk Factors This section refers to comprehensive risk factors, emphasizing going concern uncertainty as a material risk - Refer to Part I, "Item 1A. Risk Factors" in the Annual Report on Form 10-K for the year ended December 31, 2023, for comprehensive risk factors[294] - Substantial doubt about the company's ability to continue as a going concern is a significant risk, potentially leading to business limitations or cessation if mitigation efforts fail[296] ITEM 2: Unregistered Sales of Equity Securities and Use of Proceeds This item reports no unregistered sales of equity securities or use of proceeds for the period - No information provided under this item[297] ITEM 3: Defaults upon Senior Securities This item reports no defaults upon senior securities for the period - No information provided under this item[297] ITEM 4: Mine Safety Disclosures This item states that mine safety disclosures are not applicable to the company - Not Applicable[297] ITEM 5: Other Information This item reports no other information to disclose for the period - No information provided under this item[298] ITEM 6: Exhibits This section lists all exhibits filed with the Form 10-Q, including corporate documents and certifications - Lists various corporate documents, agreements, and certifications filed as exhibits[298][299][300][301][302][303][304][305][306] SIGNATURES This section contains the required signatures for the Form 10-Q, confirming its submission by authorized officers of AIM ImmunoTech Inc. Signatures This section contains the required signatures for the Form 10-Q, confirming its submission by authorized officers - Report signed by Thomas K. Equels (CEO & President) and Robert Dickey IV (CFO)[308] - Date of signature: November 14, 2024[308]