AIM ImmunoTech(AIM) - 2025 Q2 - Quarterly Report

FORM 10-Q Cover Page Registrant Information This section provides the basic identification details for AIM ImmunoTech Inc.'s Form 10-Q filing for the quarterly period ended June 30, 2025, including its legal name, state of incorporation, address, and stock exchange listing - AIM ImmunoTech Inc. is a Delaware-incorporated company with its principal executive offices in Ocala, FL[2] Securities Registered | Title of each class | Trading Symbol | Name of each exchange on which registered | | :------------------ | :------------- | :---------------------------------------- | | Common Stock, par value $0.001 per share | AIM | NYSE American | - The registrant is a Non-accelerated filer and a Smaller reporting company[4] - As of August 12, 2025, 2,708,688 shares of common stock were outstanding[4] PART I - FINANCIAL INFORMATION ITEM 1: Financial Statements This section presents the unaudited condensed consolidated financial statements of AIM ImmunoTech Inc. and its subsidiaries, including balance sheets, statements of comprehensive loss, changes in stockholders' equity, and cash flows, along with detailed notes explaining the company's business, accounting policies, and specific financial line items Condensed Consolidated Balance Sheets The company's condensed consolidated balance sheets show a significant decrease in total assets and an increase in total liabilities from December 31, 2024, to June 30, 2025, resulting in a larger stockholders' deficit Condensed Consolidated Balance Sheets (in thousands) | ASSETS | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :------------------ | | Cash and cash equivalents | $476 | $1,701 | | Marketable investments | $359 | $2,276 | | Total current assets | $1,025 | $4,176 | | Total assets | $4,129 | $8,608 | | LIABILITIES AND STOCKHOLDERS' DEFICIT | | | | Accounts payable | $7,297 | $6,383 | | Total current liabilities | $10,393 | $9,535 | | Total liabilities | $10,675 | $9,930 | | Total stockholders' deficit | ($6,546) | ($1,322) | | Total liabilities and stockholders' deficit | $4,129 | $8,608 | - Total assets decreased by approximately 52% from $8,608 thousand at December 31, 2024, to $4,129 thousand at June 30, 2025[6] - Stockholders' deficit increased significantly from ($1,322) thousand at December 31, 2024, to ($6,546) thousand at June 30, 2025[6] Consolidated Statements of Comprehensive Loss The company reported an increased net loss for the three months ended June 30, 2025, compared to the prior year, primarily due to decreased revenues and interest income, despite some reductions in general and administrative expenses Consolidated Statements of Comprehensive Loss (in thousands, except per share data) | Item | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Revenues | $25 | $50 | $41 | $90 | | Production costs | $10 | $8 | $20 | $16 | | Research and development | $1,174 | $1,145 | $2,254 | $3,096 | | General and administrative | $1,487 | $2,591 | $4,032 | $6,406 | | Operating loss | ($2,646) | ($3,694) | ($6,265) | ($9,428) | | Net Loss | ($2,794) | ($1,836) | ($6,499) | ($7,653) | | Basic and diluted loss per share | ($3.68) | ($3.00) | ($8.88) | ($15.00) | | Weighted average shares outstanding | 759,289 | 528,374 | 731,650 | 511,619 | - Net loss increased by $958 thousand (52%) for the three months ended June 30, 2025, to ($2,794) thousand, compared to ($1,836) thousand in the prior year[8][218] - Revenues decreased by 50% for the three months ended June 30, 2025, from $50 thousand to $25 thousand[8][219] - Net loss decreased by $1,154 thousand (15%) for the six months ended June 30, 2025, to ($6,499) thousand, compared to ($7,653) thousand in the prior year[8][227] Consolidated Statements of Changes in Stockholders' Equity The consolidated statements of changes in stockholders' equity reflect a growing accumulated deficit and a decrease in total stockholders' equity, primarily driven by net comprehensive losses and common stock issuances Changes in Stockholders' Equity (in thousands) | Item | Balance December 31, 2024 | Balance June 30, 2025 | | :-------------------------------- | :------------------------ | :-------------------- | | Common Stock Par Value | $1 | $1 | | Additional Paid-in Capital | $425,505 | $426,780 | | Accumulated Deficit | ($426,828) | ($433,327) | | Total Stockholders' Deficit | ($1,322) | ($6,546) | - Accumulated deficit increased from ($426,828) thousand at December 31, 2024, to ($433,327) thousand at June 30, 2025, due to net comprehensive losses[11] - Common stock shares outstanding increased from 655,263 at December 31, 2024, to 764,188 at June 30, 2025, partly due to common stock issuance and repayment of debt with shares[11] Consolidated Statements of Cash Flows The company experienced a net decrease in cash and cash equivalents for the six months ended June 30, 2025, primarily due to cash used in operating activities, partially offset by cash provided by investing and financing activities Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | ($3,892) | ($7,823) | | Net cash provided by investing activities | $1,652 | $668 | | Net cash provided by financing activities | $1,015 | $5,270 | | Net decrease in cash and cash equivalents | ($1,225) | ($1,885) | | Cash and cash equivalents at end of period | $476 | $3,554 | - Net cash used in operating activities decreased by $3,931 thousand, from ($7,823) thousand in 2024 to ($3,892) thousand in 2025[14][236] - Net cash provided by investing activities increased by $984 thousand, from $668 thousand in 2024 to $1,652 thousand in 2025, driven by increased proceeds from marketable investments[14][237] - Net cash provided by financing activities decreased significantly by $4,255 thousand, from $5,270 thousand in 2024 to $1,015 thousand in 2025, mainly due to lower proceeds from notes payable and warrant issuances[14][238] Note 1: Business and Basis of Presentation AIM ImmunoTech, an immuno-pharma company, develops Ampligen and Alferon N Injection, facing going concern doubts due to losses and NYSE non-compliance - AIM ImmunoTech Inc. is an immuno-pharma company focused on research and development of therapeutics for cancers, viral diseases, and immune-deficiency disorders[16] - Flagship products are Ampligen (rintatolimod), a double-stranded RNA molecule, and Alferon N Injection (Interferon alfa); Ampligen is approved for commercial sale in Argentina for severe Chronic Fatigue Syndrome (CFS) but not yet by the FDA in the US[17] - The company's activities prioritize clinical trials for pancreatic cancer, evaluating Ampligen for multiple cancers, exploring its antiviral activities, treating ME/CFS and Post-COVID conditions, and as a vaccine adjuvant[18][23] - The company's financial statements are prepared assuming a going concern, but substantial doubt exists due to incurred losses, net cash used in operating activities, a working capital deficit, and stockholders' equity below NYSE American minimum requirements[25][27] - A 1-for-100 reverse stock split was approved by stockholders on April 30, 2025, and took effect on June 12, 2025, to address NYSE American listing compliance[22][29] Note 2: Cash and Cash Equivalents Cash and cash equivalents include bank deposits, with some accounts exceeding federally insured limits, though the company believes credit risk is minimal - Cash and cash equivalents were $476 thousand at June 30, 2025, down from $1,701 thousand at December 31, 2024[6] - The company considers highly liquid instruments with an original maturity of three months or less as cash equivalents[30] Note 3: Marketable Securities Marketable securities, consisting of mutual funds, significantly decreased from December 2024 to June 2025, with the company recognizing a net gain on equity securities for the six months ended June 30, 2025, compared to a net loss in the prior year - Marketable investments decreased from $2,276 thousand at December 31, 2024, to $359 thousand at June 30, 2025[6][31] - A net gain of $17 thousand was recognized on equity securities for the six months ended June 30, 2025, compared to a net loss of ($177) thousand for the same period in 2024[32][33] Note 4: Property and Equipment, net Net property and equipment decreased slightly, with depreciation expense remaining consistent year-over-year Property and Equipment, net (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :------------------ | | Furniture, fixtures, and equipment | $1,466 | $1,466 | | Less: accumulated depreciation | ($1,377) | ($1,358) | | Property and equipment, net | $89 | $108 | - Depreciation expense was $19 thousand for the six months ended June 30, 2025, compared to $18 thousand for the same period in 2024[34] Note 5: Patents and Trademark Rights, Net Net patent and trademark rights decreased due to abandonments and amortization, with a remaining weighted average amortization period of approximately 12 years for patents and 7 years for trademarks Net Amortizable Patents and Trademarks Rights (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :------------------ | | Patents (Net Carrying Value) | $2,078 | $2,495 | | Trademarks (Net Carrying Value) | $90 | $99 | | Net amortizable patents and trademarks rights | $2,168 | $2,594 | - Acquisitions of patent and trademark rights totaled $283 thousand, while abandonments amounted to ($615) thousand for the six months ended June 30, 2025[36] - Amortization expense for patents and trademarks was $94 thousand for the six months ended June 30, 2025[36] Note 6: Accrued Expenses Accrued expenses slightly decreased from December 2024 to June 2025, with professional fees and clinical trial expenses being the largest components Accrued Expenses (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :------------------ | :------------ | :------------------ | | Professional fees | $308 | $416 | | Clinical trial expenses | $97 | $145 | | Interest | $106 | $11 | | Other expenses | $62 | $33 | | Total | $573 | $606 | - Accrued expenses decreased by $33 thousand from December 31, 2024, to June 30, 2025[38] Note 7: Unsecured Promissory Note The company entered into two unsecured promissory notes with Streeterville Capital LLC, incurring significant interest expense and settling a portion of debt with common stock - On February 16, 2024, the company entered into a $2.5 million unsecured promissory note with Streeterville Capital LLC, with a total repayment of approximately $3.3 million by February 16, 2026, at a 10% stated interest rate[39] - On June 30, 2025, an additional $250 thousand unsecured promissory note was entered into with Streeterville, with a total repayment of $310 thousand by October 28, 2025[40] - Interest expense related to long-term debt was $149 thousand for the three months ended June 30, 2025, and $273 thousand for the six months ended June 30, 2025[41] - In the six months ended June 30, 2025, the company settled $450 thousand of its loan obligation by issuing 20,541 shares of common stock[43] Note 8: Equity-Based Compensation The 2018 Equity Incentive Plan authorizes various equity awards, with a maximum of 4,632 unissued shares reserved as of June 30, 2025. Equity-based compensation expense decreased significantly for both the three and six months ended June 30, 2025, compared to the prior year - The 2018 Equity Incentive Plan allows for various equity awards, with 4,632 unissued shares reserved as of June 30, 2025, and an additional 15,283 shares becoming available on July 1, 2025[44] - Equity-based compensation expense was approximately $0 for the three months ended June 30, 2025 (down from $80 thousand in 2024) and $60 thousand for the six months ended June 30, 2025 (down from $160 thousand in 2024)[46][48] Employee Stock Option Activity (June 30, 2025) | Item | Number of Options | Weighted Average Exercise Price | | :-------------------------- | :---------------- | :------------------------------ | | Outstanding June 30, 2025 (Employees) | 24,063 | $238.33 | | Exercisable June 30, 2025 (Employees) | 24,063 | $156.62 | | Outstanding June 30, 2025 (Non-employees) | 8,850 | $187.59 | | Exercisable June 30, 2025 (Non-employees) | 8,850 | $161.71 | Note 9: Stockholders' Equity (Deficit) Details preferred and common stock, including a 100-to-1 reverse stock split in June 2025, and various equity financing activities - The company is authorized to issue 5,000,000 shares of preferred stock, with 4,000,000 designated as Series A Junior Participating Preferred Stock and 10,000 as Series B Convertible Preferred Stock; no Series A or B shares were outstanding as of June 30, 2025[50][51][52][54] - A 100-to-1 reverse stock split of outstanding shares was effected in June 2025 to comply with NYSE regulations, not affecting the number of authorized shares[56] - Common stock issued and outstanding increased from 655,263 shares at December 31, 2024, to 764,188 shares at June 30, 2025[55] - Under the Employee Stock Purchase Plan, the company issued 41,339 shares for $105 thousand during the three months ended June 30, 2025, and 42,171 shares for $115 thousand during the six months ended June 30, 2025[58] - The company has an Equity Distribution Agreement with Maxim to sell up to $3.1 million of common stock, and an Equity Purchase Agreement with Atlas Sciences for up to $15 million of common stock[62][66] - In May 2024, the company issued 56,410 shares of common stock and Class A and B warrants to a single accredited investor, with proceeds allocated to warrants totaling approximately $2.5 million[68][73] - In September 2024, the company issued 46,530 shares of common stock and Class C and D warrants, receiving aggregate gross proceeds of approximately $1.26 million[74][75] Note 10: Net Loss Per Share Basic and diluted net loss per share calculations exclude certain stock options and warrants as their effect is anti-dilutive - Equivalent common shares (stock options and warrants) of 13 for the three months ended June 30, 2025, and 238,792 for the six months ended June 30, 2025, were excluded from diluted EPS calculation due to their anti-dilutive effect[77] Note 11: Recent Accounting Pronouncements The company has implemented all new accounting pronouncements in effect, and management believes no recent pronouncements will have a material impact on its financial statements - The company has implemented all new accounting pronouncements in effect, and management does not believe any new pronouncements will have a material impact on its financial position or results of operations[78] Note 12: Fair Value The company measures certain assets and liabilities at fair value, categorizing them into Level 1, 2, or 3 based on input observability. Warrants with cash settlement features are classified as Level 3 and valued using a Monte Carlo Simulation with specific assumptions - Cash and cash equivalents, other assets, accounts payable, and accrued expenses are considered Level 1 instruments[80] - Class A, B, C, and D warrants are valued using a Monte Carlo Simulation, incorporating assumptions for risk-free interest rate, expected holding period, expected volatility, expected dividend yield (0%), and a 5.0% probability of a Fundamental Transaction[80][82][83][84][85] Assets Measured at Fair Value (in thousands) | Asset | As of June 30, 2025 (Total) | As of June 30, 2025 (Level 1) | As of December 31, 2024 (Total) | As of December 31, 2024 (Level 1) | | :------------------ | :-------------------------- | :---------------------------- | :------------------------------ | :------------------------------ | | Cash equivalents | $6 | $6 | $51 | $51 | | Marketable securities | $359 | $359 | $2,276 | $2,276 | Note 13: Leases The company leases office, lab facilities, and equipment under non-cancellable operating leases. Lease costs increased for the six months ended June 30, 2025, with a weighted-average remaining term of 28 months - Right of use assets were $496 thousand and operating lease liability was $515 thousand at June 30, 2025[91] Total Lease Costs (in thousands) | Lease Cost Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :----------------------------- | :----------------------------- | | Operating lease costs | $151 | $150 | | Short-term and variable lease costs | $168 | $124 | | Total lease costs | $319 | $274 | | Research & development | $215 | $227 | | General and administrative | $104 | $47 | - The weighted-average remaining lease term was 28 months at June 30, 2025, with a weighted average incremental borrowing rate of 10%[92] Future Minimum Lease Payments (in thousands) | Year Ending December 31, | | | :----------------------- | :--- | | 2025 | $142 | | 2026 | $254 | | 2027 | $159 | | Less imputed interest | ($40) | | Total | $515 | Note 14: Research, Consulting and Supply Agreements The company incurs significant R&D expenses through agreements with third-party service providers for clinical trials and manufacturing. Clinical studies remain the largest component of R&D, with ongoing work in pancreatic cancer and Post-COVID conditions Research and Development Expenses (in thousands) | R&D Component | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Clinical studies | $733 | $350 | $1,327 | $1,298 | | Manufacturing and engineering | $144 | $330 | $324 | $576 | | Quality control | $232 | $284 | $462 | $834 | | Regulatory | $64 | $180 | $140 | $389 | - Amarex Clinical Research LLC is the principal administrator for several large clinical studies, including a Phase 2 pancreatic cancer trial (AMP-270) with an estimated cost of $8.4 million[98] - Expenses related to Amarex for pancreatic cancer increased from $66.5 thousand (Q2 2024) to $94 thousand (Q2 2025) and from $153.7 thousand (H1 2024) to $192 thousand (H1 2025)[98] - A Phase 2 trial for Post-COVID Conditions managed by Amarex, with an estimated cost of $6.6 million, was completed in 2023, with minimal expenses incurred in H1 2025[101] - The company has a joint clinical study agreement with Erasmus University Medical Center Rotterdam for a Phase II study combining Ampligen with durvalumab for metastatic pancreatic cancer, providing Ampligen and an unrestricted grant of $200,000[103] Note 15: Subsequent Events Subsequent to June 30, 2025, the company increased shares available under its equity incentive plan, closed an $8 million public offering, repaid a bridge note early, and reduced outstanding accounts payable - On July 1, 2025, an additional 15,283 shares of common stock became available for grant under the Amended and Restated 2018 Equity Incentive Plan[106] - On July 30, 2025, the company closed a public offering, raising $8 million in gross proceeds through the issuance of common stock (or pre-funded warrants) and Class E and F warrants[107][109] - On August 1, 2025, the Streeterville Bridge Note was repaid early for $285 thousand, taking advantage of an early repayment discount[110] - On August 12, 2025, the company reduced its outstanding accounts payable to a vendor, aiming to alleviate negative working capital and increase Shareholders' Equity[111] 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 and results of operations, highlighting key performance drivers, liquidity challenges, and strategic initiatives related to its product development and funding efforts Special Note Regarding Forward-Looking Statements This section serves as a cautionary note, indicating that the report contains forward-looking statements subject to risks and uncertainties, and actual results may differ materially. The company disclaims any obligation to update these statements - The report contains forward-looking statements regarding strategy, future operations, financial position, revenues, costs, plans, prospects, and objectives, identified by words like 'expect,' 'anticipate,' and 'intend'[112] - Forward-looking statements are not guarantees of performance and actual results could vary materially due to risks and uncertainties, including the success of clinical trials for Ampligen[112] - The company disclaims any obligation to update forward-looking statements to reflect future events or developments[115] Overview AIM ImmunoTech develops Ampligen for cancers, viral diseases, and ME/CFS, prioritizing pancreatic cancer trials, and manages Alferon N Injection, manufacturing, licensing, and marketing - AIM ImmunoTech Inc. is an immuno-pharma company focused on research and development of therapeutics for cancers, viral diseases, and immune-deficiency disorders, with Ampligen (rintatolimod) as its flagship product[118][119] - The company prioritizes clinical activities, with pancreatic cancer trials having the highest priority, aiming for FDA or EMA authorization to support potential New Drug Applications (NDAs)[120] - Ampligen is being evaluated for pancreatic cancer, other solid tumors (in combination with checkpoint inhibitors), antiviral activities (including avian influenza), ME/CFS, and Post-COVID conditions[124] - Alferon N Injection, an FDA-approved natural alpha-interferon for genital warts, is currently not being manufactured, and the company is not focusing on its development at this time[198] - The company utilizes CMOs like Jubilant HollisterStier for Ampligen manufacturing and Sterling Pharma Solutions for polymer precursors, with validation of the polymer production process ongoing[200][202] - AIM's strategy includes licensing and collaborations to commercialize Ampligen globally, with ongoing discussions with Filaxis for pancreatic cancer indications in Argentina[204][205] General AIM ImmunoTech Inc. is an immuno-pharma company focused on R&D of therapeutics for various diseases, with Ampligen and Alferon N Injection as key products. The company prioritizes clinical development, especially for pancreatic cancer, aiming for regulatory approvals - AIM ImmunoTech Inc. is an immuno-pharma company focused on research and development of therapeutics for cancers, viral diseases, and immune-deficiency disorders[118] - Ampligen is the flagship product, a double-stranded RNA molecule, approved for commercial sale in Argentina for severe Chronic Fatigue Syndrome but not yet in the United States[119] - The company prioritizes clinical activities, with pancreatic cancer having priority, aiming for trials authorized by the FDA or EMA to support potential New Drug Applications (NDAs)[120] Immuno-Oncology AIM's immuno-oncology efforts focus on Ampligen for pancreatic cancer, showing promising survival data, and exploring its potential as a combination therapy with checkpoint inhibitors for various solid tumors - Pancreatic cancer is a major focus due to promising results from Netherlands studies, showing Ampligen extended survival beyond the Standard of Care[121] - Ampligen is being evaluated as a potential therapy to modify the tumor microenvironment and increase anti-tumor responses to checkpoint inhibitors across multiple cancers[122][147] - The DURIPANC Study (Phase 1b/2) combining Ampligen with AstraZeneca's durvalumab for late-stage pancreatic cancer has shown no significant toxicity and positive mid-year safety and efficacy, with 64% of eligible subjects having >6 months overall survival[148] - A Phase 2 study for advanced recurrent ovarian cancer using cisplatin, pembrolizumab, and Ampligen reported an Objective Response Rate (ORR) of 45% in platinum-sensitive subjects and a Clinical Benefit Rate (CBR) of 55%[148] - The company holds multiple patents related to Ampligen's use in cancer treatment, including a Netherlands patent for combination therapy with checkpoint inhibitors (March 2021) and a US patent for manufacturing dsRNA products (June 2025)[149] - Ampligen received Orphan Drug Designation from the FDA (December 2020) and the European Commission (February 2021) for the treatment of pancreatic cancer[162] Ampligen as a Potential Antiviral AIM is exploring Ampligen's broad-spectrum antiviral capabilities, particularly for COVID-19 and avian influenza, based on promising pre-clinical data and completed Phase 1 safety studies for intranasal administration - Ampligen has a research and pre-clinical history indicating broad-spectrum antiviral capability in animals against viruses like SARS-CoV-1, Ebola, and Vaccinia Virus[125] - The company intends to pursue a study of Ampligen in combination with AstraZeneca's FluMist as an intranasal vaccine for influenza, including avian influenza, based on previous research showing increased immune response[126] - A Phase 1 randomized, double-blind study of intranasal Ampligen in 40 healthy subjects reported no Serious or Severe Adverse Events at any dosage level, supporting its safety[127][175] - Ampligen is believed to activate antiviral immune system pathways that fight various viruses and variants, rather than directly attacking a specific virus[128] Ampligen as a treatment for ME/CFS and Post-COVID Conditions AIM pursues FDA approval for Ampligen in ME/CFS, with commercial approval in Argentina, and evaluates Ampligen for Post-COVID conditions, showing positive preliminary results from AMP-511 and AMP-518 - Ampligen received commercial sale approval in Argentina for severe CFS in August 2016, but hyper-inflation and peso devaluation have made treatment costs prohibitive, shifting focus to oncology indications in Argentina[131][132] - The AMP-511 open-label expanded access treatment protocol for severely debilitated CFS patients was expanded in October 2020 to include patients with Post-COVID conditions, with 4 patients enrolled as of June 30, 2025[133][142] - Preliminary results from AMP-511 for Post-COVID patients showed a clinically significant decrease in fatigue-related measures and improvement in cognition by week 12[133][142] - Final Clinical Study results from AMP-518 (Phase 2 for Post-COVID conditions) posted in January 2025 support Ampligen as a potential therapeutic for moderate-to-severe Post-COVID fatigue, with a significant improvement in the Six-Minute Walk Test for subjects with lower baseline performance[134][180] OUR PRODUCTS AIM's primary product is Ampligen (rintatolimod), a TLR3 agonist with broad-spectrum antiviral and anti-cancer properties, approved in Argentina for CFS and undergoing clinical development in the US for various indications. Alferon N Injection production is on hold - Ampligen (rintatolimod) is a first-in-class large macromolecular double-stranded RNA (dsRNA) molecule and a selective TLR3 agonist, designed to act at the molecular level for various human diseases[136][138] - Ampligen is approved for sale in Argentina for severe CFS (until 2026) and is an experimental drug in the US undergoing clinical development for cancers, ME/CFS, and Post-COVID Conditions[137] - Expanded Access Programs and clinical trials for Ampligen include studies for pancreatic cancer, renal cell carcinoma, malignant melanoma, ovarian cancer, ME/CFS, Hepatitis B, HIV, COVID-19, and Post-COVID conditions[139] - Alferon N Injection is an FDA-approved natural-source, multi-species alpha interferon for intralesional treatment of refractory or recurring external genital warts in the US and Argentina[196] - Production of new Alferon N Injection Active Pharmaceutical Ingredient (API) is currently on hold, and the company is not focusing on its development at this time[198] MANUFACTURING AIM utilizes Contract Manufacturing Organizations (CMOs) like Jubilant HollisterStier for Ampligen production and Sterling Pharma Solutions for polymer precursors. While Ampligen has sufficient API for current needs, Alferon N Injection production is on hold with no definitive restart timetable - Jubilant HollisterStier is AIM's authorized CMO for Ampligen, having manufactured multiple lots, including in December 2023[200] - The company entered into a Master Service Agreement with Sterling Pharma Solutions in December 2022 for the manufacture of Poly I and Poly C12U polynucleotides, with the validation of the polymer production process ongoing[202] - Production of new Alferon N Injection API is currently on hold, and commercial sales in the US will not resume until new batches are produced and released by the FDA[203] LICENSING/COLLABORATIONS/JOINT VENTURES AIM is pursuing a strategy to license Ampligen and collaborate with partners to gain regulatory approval and commercialize the product worldwide, particularly exploring oncology indications in Argentina with Filaxis - The company's strategy is to license Ampligen and/or collaborate with companies that have capabilities to gain approval and commercialize Ampligen globally[204] - AIM is exploring the potential for Ampligen in Argentina for pancreatic cancer, either as a monotherapy or in combination with immunotherapies, with Filaxis[205] MARKETING/DISTRIBUTION AIM has agreements with Filaxis for Ampligen distribution in Argentina (extended until 2026) and myTomorrows for Early Access Programs in Europe, Canada, and Turkey for ME/CFS and pancreatic cancer. Efforts to find new partners for Alferon N Injection are ongoing - AIM has an exclusive Sales, Marketing, Distribution and Supply Agreement with Filaxis (formerly GP Pharm) for Ampligen in Argentina, with regulatory approval extended until 2026[206] - An agreement with myTomorrows manages Early Access Programs (EAPs) for Ampligen in Europe, Canada, and Turkey for ME/CFS and pancreatic cancer patients, with the agreement automatically extended annually[207][210][212] - The company is seeking new partners to move forward with the Naturaferon (Alferon N Injection) project in Argentina after Filaxis decided to discontinue its efforts[209] 401(k) Plan The company's 401(k) Plan allows full-time employees to contribute, with a 6% safe harbor matching contribution reinstated in January 2021 but discontinued effective June 1, 2025 - A 6% safe harbor matching contribution by the company to its 401(k) Plan was reinstated effective January 1, 2021, but discontinued effective June 1, 2025[215] - The company made approximately $57 thousand in 401(k) contributions for the six months ending June 30, 2025[215] New Accounting Pronouncements The company has adopted all new accounting pronouncements, and management does not anticipate any material impact on its financial statements from recently issued pronouncements - The company has implemented all new accounting pronouncements in effect and does not believe any new pronouncements will have a material impact on its financial position or results of operations[216][78] Critical Accounting Policies and Estimates There have been no material changes to the company's critical accounting policies and estimates since its Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes have occurred in the company's critical accounting policies and estimates since the December 31, 2024, Annual Report on Form 10-K[217] RESULTS OF OPERATIONS The company's results show an increased net loss for the three months ended June 30, 2025, due to decreased income and revenues, partially offset by reduced G&A and warrant valuation losses. For the six-month period, net loss decreased due to significant reductions in G&A and R&D expenses Three months ended June 30, 2025 versus three months ended June 30, 2024 For the three months ended June 30, 2025, net loss increased by 52% to $2.794 million, driven by a significant decrease in interest and other income and reduced revenues, partially offset by lower general and administrative expenses and warrant valuation losses - Net loss increased by $958 thousand (52%) to $2,794 thousand for the three months ended June 30, 2025, compared to $1,836 thousand in the prior year[218] - Revenues decreased by $25 thousand (50%) to $25 thousand, primarily due to fluctuation in patient participation in the Ampligen® Cost Recovery Program[219] - Interest and other income decreased by $2,570 thousand, contributing significantly to the increased net loss[225] - General and administrative expenses decreased by $1,104 thousand, mainly due to lower professional fees, salaries, and investment banker fees[224][225] - Research and development costs increased by $29 thousand, primarily due to higher patent and trademark expenses, offset by decreases in salaries and outside contractors[223][225] Six Months ended June 30, 2025 versus Six Months ended June 30, 2024 For the six months ended June 30, 2025, net loss decreased by 15% to $6.499 million, primarily driven by substantial reductions in general and administrative expenses and research and development costs, despite a significant decrease in interest and other income - Net loss decreased by $1,154 thousand (15%) to $6,499 thousand for the six months ended June 30, 2025, compared to $7,653 thousand in the prior year[227] - General and administrative expenses decreased by $2,374 thousand, mainly due to lower professional fees, salaries, and investment banker fees[233][234] - Research and development costs decreased by $842 thousand, primarily due to lower clinical expenses, salaries, and outside contractors, partially offset by increased patent and trademark expenses[232][234] - Interest and other income decreased by $2,640 thousand, negatively impacting the net loss[234] - Revenues decreased by $49 thousand (54%) to $41 thousand, primarily due to fluctuation in patient participation[228][234] Liquidity and Capital Resources The company faces substantial doubt about its going concern due to operating losses, a working capital deficit, and NYSE American non-compliance. Cash and equivalents declined significantly, relying on financing activities and exploring various funding sources, including a recent $8 million public offering - Cash used in operating activities decreased by $3,931 thousand to $3,892 thousand for the six months ended June 30, 2025, compared to $7,823 thousand in the prior year[236] - Cash and cash equivalents, and marketable investments totaled $835 thousand as of June 30, 2025, a decrease of $3,142 thousand from December 31, 2024[239] - The company has incurred losses from operations and has a working capital deficit, raising substantial doubt about its ability to continue as a going concern[240][242] - As of June 30, 2025, current liabilities exceeded current assets by $9,368 thousand[241] - Subsequent to June 30, 2025, the company closed a public offering on July 30, 2025, raising $8 million in gross proceeds[252] Potential Delisting from the NYSE American AIM received a noncompliance notice from NYSE American due to low stockholders' equity and stock price, leading to a temporary delisting and subsequent reinstatement after a 1-for-100 reverse stock split - On December 11, 2024, the company received a noncompliance notice from NYSE American for not meeting the $6.0 million stockholders' equity requirement[246] - The NYSE American accepted the company's plan to regain compliance by June 11, 2026[246] - Trading in common stock was suspended on April 4, 2025, due to the price dropping below $0.10 per share, leading to delisting from NYSE American and trading on the Pink Open Market[246] - A 1-for-100 reverse stock split was effected in June 2025, and the company was notified on June 11, 2025, that it had regained compliance and trading was reinstated on NYSE American on June 17, 2025[248] Possible Sources of Funding The company is actively pursuing various funding sources, including a Universal Shelf Registration Statement for up to $100 million, an At-The-Market (ATM) offering with Maxim for up to $3 million, and an Equity Purchase Agreement with Atlas Sciences for up to $15 million, in addition to recent securities purchase agreements - A Universal Shelf Registration Statement on Form S-3 was filed in April 2025 to offer up to $100 million in various securities, though it has not yet been declared effective[253] - An Equity Distribution Agreement with Maxim Group LLC allows the company to sell up to $3 million of common stock through an At-The-Market (ATM) offering[254] - An Equity Purchase Agreement with Atlas Sciences, LLC commits Atlas to purchase up to $15 million of common stock over 24 months, at the company's discretion[263][264] - As of June 30, 2025, 30,829 shares have been issued to Atlas pursuant to the purchase agreement for approximately $398 thousand after clearing costs[273] - In May 2024, the company issued 56,410 shares and Class A/B warrants to an accredited investor, and in September 2024, issued 46,530 shares and Class C/D warrants, raising approximately $1.26 million[274][280][281] PART II – OTHER INFORMATION ITEM 1: Legal Proceedings This section refers to the legal proceedings detailed in the company's Annual Report on Form 10-K and provides an update on a recent court decision regarding a complaint against BioLife Plasma Services, L.P - On July 28, 2025, the Superior Court of Pennsylvania affirmed the dismissal of the company's complaint against BioLife Plasma Services, L.P., with judgment entered dismissing the case[286] - The parties have 14 days to seek further review or appeal, or to take other action in the Common Pleas Court, including reinstatement of BioLife's counterclaim for $96,000[286] ITEM 1A: Risk Factors This section directs readers to the comprehensive list of risk factors detailed in the company's Annual Report on Form 10-K, emphasizing that additional unknown or immaterial risks could also adversely affect the business - Readers are advised to consider risk factors discussed in Part I, Item 1A of the Annual Report on Form 10-K for the year ended December 31, 2024[287] - The company notes that new risk factors and uncertainties may emerge, and not all can be predicted or assessed for their impact[114][287] ITEM 2: Unregistered Sales of Equity Securities and Use of Proceeds This section states that there were no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities or use of proceeds were reported[288] ITEM 3: Defaults upon Senior Securities This section indicates that there were no defaults upon senior securities during the reporting period - No defaults upon senior securities were reported[289] ITEM 4: Mine Safety Disclosures This section states that mine safety disclosures are not applicable to the company - Mine Safety Disclosures are not applicable to the company[290] ITEM 5: Other Information This section indicates that there is no other information to report for the period - No other information was reported[291] ITEM 6: Exhibits This section lists the exhibits filed with the Form 10-Q, including agreements, certifications, and XBRL documents - Exhibits include an agreement between the company and Messrs. Equels and Rodino, certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act, and Inline XBRL documents[292] SIGNATURES Signatures The report is duly signed on behalf of AIM ImmunoTech Inc. by its Chief Executive Officer & President, Thomas K. Equels, and Chief Financial Officer, Robert Dickey IV, as of August 14, 2025 - The report was signed by Thomas K. Equels, Esq., Chief Executive Officer & President, and Robert Dickey IV, Chief Financial Officer, on August 14, 2025[295]