Core Insights - AIM ImmunoTech Inc. reported solid clinical and operational execution in Q3 2025, focusing on advancing Ampligen towards FDA approval for pancreatic cancer treatment [2] - Positive mid-year safety and efficacy data from the DURIPANC clinical trial combining Ampligen with AstraZeneca's Imfinzi were highlighted, with a year-end update expected [2] Financial Highlights - As of September 30, 2025, AIM reported cash, cash equivalents, and marketable investments of $2.4 million [8] - Research and development expenses for Q3 2025 were approximately $607,000, a decrease from $1.4 million in Q3 2024 [8] - General and administrative expenses were approximately $1.8 million for Q3 2025, down from $3.1 million in the same period of 2024 [8] - The net loss from operations for Q3 2025 was approximately $(3.3 million), or $(1.57) per share, compared to $(3.7 million), or $(6.00) per share, for Q3 2024 [8] - The company expects a monthly burn rate of approximately $550,000 while maintaining operational efficiencies [8]

Financial Performance - Net loss for the three months ended September 30, 2025, was approximately $3,284,000, a decrease of 11% from $3,700,000 in the same period of 2024[221] - The company incurred a net loss of approximately $9,783,000 for the nine months ended September 30, 2025, a decrease of 14% from $11,353,000 in 2024[234] Revenue and Income - Revenues from the Ampligen® Cost Recovery Program decreased to $26,000 for the three months ended September 30, 2025, down from $35,000 in 2024, reflecting a decrease of $9,000[223] - Interest and other income increased significantly to approximately $3,052,000 for the three months ended September 30, 2025, compared to $718,000 in 2024, an increase of approximately $2,334,000[225] Expenses - Research and Development costs decreased to approximately $607,000 for the three months ended September 30, 2025, down from $1,437,000 in 2024, reflecting a decrease of approximately $830,000[228] - General and Administrative expenses decreased to approximately $1,798,000 for the three months ended September 30, 2025, from $3,079,000 in 2024, a reduction of approximately $1,281,000[229] Cash Flow - Cash used in operating activities for the nine months ended September 30, 2025, was approximately $8,971,000, a decrease of $1,962,000 from $10,933,000 in 2024[247] - Cash provided by financing activities increased to approximately $7,669,000 for the nine months ended September 30, 2025, compared to $5,407,000 in 2024, an increase of $2,262,000[249] - As of September 30, 2025, the company had approximately $2,409,000 in cash and cash equivalents, a decrease of approximately $1,568,000 from December 31, 2024[250] Stockholder Equity and Compliance - As of September 30, 2025, the company's stockholders' deficit was approximately ($6,077,000), necessitating an increase in stockholders' equity to at least $6,000,000 to regain compliance with exchange listing requirements[259] - The company is required to maintain Stockholders Equity of $6,000,000 to comply with NYSE American continued listing requirements[295] Securities and Financing Activities - The company filed a Universal Shelf Registration Statement to register the offering of up to $100,000,000 of various securities, which has not yet been declared effective[262] - An Equity Distribution Agreement with Maxim allows the company to issue and sell up to $3,000,000 of common stock, with a commission of 3.0% on gross proceeds from each sale[263][266] - The company has entered into a Purchase Agreement with Atlas Sciences, committing to purchase up to $15,000,000 of common stock, with the registration statement declared effective on May 1, 2024[272][273] - As of September 30, 2025, a total of 30,829 shares have been issued under the Purchase Agreement for approximately $398,000 after clearing costs[282] - On June 3, 2024, the company issued 56,410 shares of common stock and warrants to a single accredited investor, with warrants exercisable at $36.30 per share[283] - The company received approximately $1,260,000 in gross proceeds from the Transactions before deducting fees to the Placement Agent and other estimated offering expenses[290] - The company issued 46,530 shares of common stock at a purchase price of $28.00 per share in a registered direct offering[289] - The Class E and F warrants were issued at a combined public offering price of $4.00 per share, with gross proceeds of approximately $8,000,000 before deducting placement agent fees and offering expenses[293] - The exercise price for the Class C and Class D Warrants is set at $28.00, and they are not exercisable until December 3, 2024[291] - The Common Warrants have an allocated proceeds total of approximately $2,500,000, with no warrants exercised for the nine months ended September 30, 2025[288] - The Class E and F Warrants were classified as liabilities on the balance sheet as they may require the company to issue additional stock under certain circumstances[294] - The Placement Agent received a cash fee of 8% of the aggregate gross proceeds from the securities sold in the Transactions[287] - The registration statement for the resale of Common Warrant Shares was declared effective by the SEC on July 11, 2024[286] Other Financial Obligations - The company recognized losses from warrant issuances of $4,410,000 during the nine months ended September 30, 2025[234] - The company has an outstanding deposit of $240,000 as of September 30, 2025, which may be used to offset future clinical research expenditures[256] - The company entered into a Forbearance Agreement with a lender, resulting in an outstanding balance of $2,484,000 after applying a 1% fee[257] - The company has a lock-up agreement preventing executive officers and directors from selling securities for 90 days following the closing of the Transactions[285]

Core Insights - AIM ImmunoTech Inc. presented data from a Phase 2 clinical study on Ampligen for advanced recurrent ovarian cancer, showing promising results at the 40th Annual SITC Meeting [1][2] Study Results - The study involved 27 platinum-sensitive patients, with 24 evaluable for response; 5 achieved complete response and 7 had partial response, resulting in an Objective Response Rate (ORR) of 50% [2] - This ORR is significantly higher compared to previous studies, such as Keynote-100, which reported ORRs of 7.4% and 9.9% for pembrolizumab alone [2] Mechanism and Potential - AIM believes that Ampligen can act synergistically with checkpoint inhibitors, potentially benefiting patients who do not respond to these therapies alone [3] - The study's findings suggest that Ampligen may enhance traditional cancer treatments, improving immune responses and prolonging remission for patients with limited options [4] Intellectual Property - AIM holds several patents related to the use of Ampligen in combination with checkpoint inhibitors, with expiration dates ranging from 2039 to 2040 in various jurisdictions [5] Company Overview - AIM ImmunoTech Inc. focuses on developing therapeutics for cancers, immune disorders, and viral diseases, with Ampligen as its lead investigational drug [7]

Core Insights - AIM ImmunoTech Inc. announced that data from its Phase 2 clinical study on cisplatin-resistant advanced recurrent ovarian cancer using Ampligen (rintatolimod) was accepted for presentation at the 40th Annual SITC Meeting [1] - The study focuses on a combination locoregional chemoimmunotherapy approach and its correlation with clinical outcomes [1] Company Overview - AIM ImmunoTech Inc. is an immuno-pharma company dedicated to developing therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19 [2] - The company's lead product, Ampligen (rintatolimod), is a first-in-class investigational drug that acts as a dsRNA and highly selective TLR3 agonist immuno-modulator [2]

Core Insights - AIM ImmunoTech Inc. has been granted a European patent for its proprietary dsRNA compositions aimed at treating Long COVID, specifically covering Ampligen (rintatolimod) [1] - The company is focused on advancing its pancreatic cancer clinical program while the new patent enhances its intellectual property portfolio and validates Ampligen's potential as a broad-spectrum immunotherapy [2] Company Overview - AIM ImmunoTech Inc. is an immuno-pharma company dedicated to developing therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19 [4] - The lead product, Ampligen, is a first-in-class investigational drug that acts as a dsRNA and TLR3 agonist, demonstrating broad-spectrum activity in clinical trials [4] Clinical Research and Development - Ampligen has shown a broad-spectrum, early-onset antiviral effect by stimulating a strong innate immune response, with data indicating significant decreases in viral replication in SARS-CoV-1 studies [3] - A Phase 2 study (AMP-518) has reported positive topline results, suggesting that Ampligen is generally well tolerated and may reduce fatigue in patients with Long COVID [3]

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Core Points - AIM ImmunoTech Inc. will participate in the 2025 Maxim Growth Summit on October 22-23, 2025, in New York, NY, which focuses on industry trends and advancements [1] - Management will be available for in-person one-on-one meetings with registered investors during the conference [2] - AIM ImmunoTech is an immuno-pharma company developing therapeutics for cancers, immune disorders, and viral diseases, with its lead product being Ampligen, currently in Phase 2 clinical trials for metastatic pancreatic cancer in collaboration with AstraZeneca [4] Company Information - AIM ImmunoTech Inc. specializes in research and development of therapeutics targeting multiple diseases, including COVID-19 [4] - The company's lead product, Ampligen (rintatolimod), is a first-in-class investigational drug that acts as a dsRNA and TLR3 agonist [4] - AIM ImmunoTech is focused on broad-spectrum activity in clinical trials, particularly in combination therapies for cancer treatment [4] Event Information - The Maxim Growth Summit is organized by Maxim Group LLC, a full-service investment banking and wealth management firm based in New York [3] - The summit will feature industry leaders and innovators discussing the latest trends across various sectors [1] - For more details on the summit agenda and AIM's presentation, interested parties can visit the respective websites [2]

Core Viewpoint - AIM ImmunoTech Inc. has received a Zacks Rank 2 (Buy) upgrade, indicating a positive outlook driven by rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, particularly influenced by institutional investors who adjust their valuations based on these estimates [4][6]. - For AIM ImmunoTech, the recent upgrade reflects an improvement in the company's business fundamentals, suggesting that investor sentiment may lead to increased stock prices [5][10]. Earnings Estimate Revisions - For the fiscal year ending December 2025, AIM ImmunoTech is projected to earn -$6.79 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 78.1% over the past three months, indicating a positive trend in earnings expectations [8]. Zacks Rank System - The Zacks Rank system categorizes stocks based on earnings estimate revisions, with only the top 20% of stocks receiving a "Strong Buy" or "Buy" rating, positioning AIM ImmunoTech favorably for potential market-beating returns [9][10].

Core Viewpoint - AIM ImmunoTech Inc. has received a patent from the Japan Patent Office for the use of Ampligen in combination with checkpoint inhibitors for cancer treatment, enhancing its international market protection and potential for revenue growth [1][2]. Group 1: Patent and Market Implications - The Japan patent strengthens AIM's intellectual property portfolio in a significant oncology market, expiring on December 20, 2039, and enhances exclusivity for combination therapies targeting high-need cancer indications [2][4]. - The patent claims cover a wide range of cancer types, including pancreatic, skin, colorectal, ovarian, melanoma, breast, head and neck, bladder, renal cell carcinoma, and lung cancer, along with specific dosing regimens and administration routes [3]. Group 2: Clinical Development and Collaborations - AIM is advancing its clinical pipeline with Ampligen in combination with AstraZeneca's durvalumab for metastatic pancreatic cancer, showing promising results in Progression-Free Survival and Overall Survival [5]. - A Phase 2 study with Merck Sharp & Dohme LLC combining Ampligen with Keytruda for advanced recurrent ovarian cancer has been completed, with final data expected soon [6]. Group 3: Company Overview - AIM ImmunoTech Inc. focuses on developing therapeutics for various cancers, immune disorders, and viral diseases, with Ampligen being a first-in-class investigational drug that acts as a TLR3 agonist [7].

Core Insights - AIM ImmunoTech Inc. is a biotechnology company focused on developing immune-based therapies, with its flagship product Ampligen being explored for multiple therapeutic applications [1] - AIM demonstrates exceptional capital efficiency with a Return on Invested Capital (ROIC) of 443.97%, significantly exceeding its Weighted Average Cost of Capital (WACC) of 5.83%, resulting in a ROIC to WACC ratio of 76.10 [2][6] - In contrast, AIM's peers, including Aytu BioPharma, iBio, Co-Diagnostics, Cocrystal Pharma, and NanoViricides, show negative ROIC to WACC ratios, indicating inefficiencies in capital utilization [3][4][5][6] Company Performance - AIM's ROIC of 443.97% indicates effective use of capital to generate substantial returns, setting it apart from its peers in the biotechnology sector [2][6] - The company's ROIC to WACC ratio of 76.10 highlights its ability to generate returns far exceeding its cost of capital, showcasing strong capital efficiency [2][6] Peer Comparison - Aytu BioPharma has a ROIC of -2.78% and a WACC of 18.15, resulting in a negative ROIC to WACC ratio of -0.15, indicating capital inefficiency [3] - iBio reports a ROIC of -117.47% and a WACC of 6.80, leading to a negative ROIC to WACC ratio of -17.28, further illustrating struggles in capital efficiency [4] - Co-Diagnostics and Cocrystal Pharma also exhibit negative ROIC to WACC ratios of -13.01 and -13.80, respectively, highlighting ongoing challenges in generating adequate returns [4] - NanoViricides shows a ROIC of -111.71% and a WACC of 9.11, resulting in a negative ROIC to WACC ratio of -12.27, underscoring the difficulties faced by AIM's peers [5]