Ampligen Program & Pipeline - Ampligen, an immuno-modulator, is the lead program with broad-spectrum activity demonstrated in human clinical studies[7] - The company is advancing a broad pipeline across multiple indications including Immuno-Oncology, Immune Disorders, and Viral Diseases[9] - The company plans to conduct a Phase 1/2 or Phase 2 study in collaboration with the University of Alabama-Birmingham, focusing on influenza, including avian influenza (Bird Flu)[10] Oncology Programs - The company is targeting multiple cancers with high unmet needs through immuno-therapy oncology programs[18] - In an Early Access Program for late-stage pancreatic cancer, the median overall survival (OS) was 19 months in the Ampligen cohort compared to 12 months for a well-matched historical control group[29] - The 19 months OS in Ampligen cohort represents 79 month increase survival benefit compared to current standard of care[29] - The company is enrolling and dosing patients in a Phase 2 study (DURIPANC) for Metastatic Pancreatic Ductal Adenocarcinoma, using Ampligen in combination with durvalumab[27] - Additional target oncology indications include Ovarian Cancer (19880 new cases annually), Breast Cancer (287850 new cases annually), Colorectal Cancer (151030 new cases annually), and Melanoma (99780 new cases annually)[26] Post-COVID Conditions - The company is exploring Ampligen as a potential treatment for Post-COVID Conditions, particularly fatigue, with a follow-up clinical trial planned[37] - Preliminary data from a study at the Hunter-Hopkins center showed improvements in exercise ability, overall fatigue levels, and post-exertional malaise in 4 patients treated for Long-COVID[38] - Final clinical study results on AMP-518 indicate that Ampligen improves measures of fatigue over placebo[42] Intellectual Property & Exclusivity - Ampligen has Orphan Drug Designation from the FDA and EMA, providing 7 years and 10 years of market exclusivity following approval, respectively[54] - The company has 46 patents worldwide and 72 pending applications[54]

Core Viewpoint - AIM ImmunoTech Inc. has secured a significant patent for the manufacturing of its drug Ampligen, extending patent protection until 2041, which enhances its control over the drug's synthesis and use in various therapeutic applications [1][2][3]. Patent Protection - The newly granted U.S. patent No. 12312376 covers methods for manufacturing a range of therapeutic double-stranded RNA products, including Ampligen, thereby strengthening AIM's intellectual property portfolio [1][2]. - AIM's overall patent portfolio includes protections for Ampligen in treating various conditions, with specific patents expiring between 2039 and 2042 [4]. Development and FDA Approval - The patent extension provides AIM with additional time to develop its drug program and pursue FDA approval for Ampligen across multiple indications, including cancers and viral diseases [3][5]. - AIM's intellectual property also includes multiple Orphan Drug Designations from the FDA and EMA, granting market exclusivity for seven to ten years post-approval for various conditions [5]. Company Overview - AIM ImmunoTech Inc. is focused on developing therapeutics for cancers, immune disorders, and viral diseases, with Ampligen being its lead investigational drug, demonstrating broad-spectrum activity in clinical trials [6].

Core Viewpoint - AIM ImmunoTech Inc. has announced the withdrawal of its delisting determination by NYSE Regulation, allowing its common stock to resume trading on the NYSE American starting June 17, 2025 [1] Company Overview - AIM ImmunoTech Inc. is an immuno-pharma company focused on developing therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19 [2] - The company's lead product is Ampligen (rintatolimod), a first-in-class investigational drug that acts as a dsRNA and highly selective TLR3 agonist immuno-modulator, showing broad-spectrum activity in clinical trials [2]

Group 1 - AIM ImmunoTech Inc. announced a reverse stock split at a ratio of 1-for-100, effective June 12, 2025 [1] - The primary goal of the reverse stock split is to increase the per-share market price to regain compliance with NYSE American's Listing Qualifications [2] - Stockholders approved the reverse stock split at a Special Meeting on April 30, 2025, and will receive cash for any fractional shares post-split [3] Group 2 - AIM ImmunoTech Inc. focuses on the research and development of therapeutics for cancers, immune disorders, and viral diseases, including COVID-19 [4] - The company's lead product is Ampligen® (rintatolimod), an investigational drug with broad-spectrum activity in clinical trials [4]

Core Insights - AI-Media Technologies Limited has formed a groundbreaking partnership with Lightning International to enhance accessibility and monetization opportunities for FAST platforms globally [1][2][3] Group 1: Partnership Overview - The collaboration aims to break barriers and bring engaging entertainment to audiences worldwide while transforming the distribution and monetization of premium content in diverse markets [1] - AI-Media's solutions, LEXI and LEXI Translate, enable real-time localization and embedding of subtitles in over 50 languages, expanding audience reach beyond English-speaking markets [2][3] Group 2: Benefits to FAST Platforms - The partnership addresses key challenges in providing superior localized content to global audiences, allowing viewers to enjoy various genres without language barriers [2] - AI-Media's CEO, Tony Abrahams, emphasized that this collaboration is a game-changer for the FAST industry, helping platforms expand their audience and increase revenue [2] Group 3: Operational Mechanism - AI-Media's Alta and LEXI Translate solutions provide seamless integration of real-time transcription and translation into linear channel content, ensuring an efficient and cost-effective workflow [3] - Lightning International's CEO, James Ross, highlighted that this partnership sets a new standard for localization in the FAST industry, enabling access to diverse content for all viewers [3] Group 4: Company Background - AI-Media, established in 2003, is a global leader in AI-driven real-time speech translation, subtitles, and accessibility solutions, with innovations like LEXI Voice enhancing live content understanding [4][5] - The company's solutions cater to the growing demand for subtitles among millennials and Gen Z, with 87% of viewers finding subtitles helpful for content consumption [4] Group 5: Lightning International Overview - Lightning International focuses on creating and distributing television channels and programs, having launched over 15 FAST channels available on multiple platforms globally [6] - The company has been a member of AsiaSat since 2023, enhancing its capabilities in the content distribution landscape [6]

Core Insights - AI-Media is participating in two major industry events in Asia: KOBA 2025 in Seoul and Broadcast Asia 2025 in Singapore, showcasing its AI-powered language solutions [1][2][3] Group 1: Company Innovations - AI-Media is introducing LEXI Voice, a real-time multilingual voice translation technology that allows broadcasters and event producers to engage diverse audiences without the need for human interpretation, offering translation into over 100 languages [4][7] - LEXI Voice can reduce live translation costs by up to 90%, making multilingual delivery commercially viable for many customers [5][7] - The company’s technology will provide live captions at Broadcast Asia 2025, ensuring accessibility for global audiences [3][6] Group 2: Market Engagement - AI-Media is collaborating with BS Systems at KOBA 2025 to demonstrate advancements in AI captioning and multilingual translation technology [2][4] - The company aims to empower broadcasters and content creators across Asia by showcasing its solutions that enhance global accessibility and engagement [2][7] - AI-Media's end-to-end ecosystem, including products like iCap, LEXI, and Encoder Pro, is designed to deliver unmatched automation and scalability, replacing legacy human workflows [8]

Financial Performance - Net loss for Q1 2025 was approximately $3,705,000, a decrease of 36% from a net loss of $5,817,000 in Q1 2024[217]. - Revenues from the Ampligen® Cost Recovery Program decreased to $16,000 in Q1 2025 from $40,000 in Q1 2024, a decline of $24,000[218]. - Research and Development costs decreased to approximately $1,080,000 in Q1 2025 from $1,951,000 in Q1 2024, reflecting a reduction of approximately $871,000[222]. - General and Administrative expenses decreased to approximately $2,545,000 in Q1 2025 from $3,815,000 in Q1 2024, a decrease of approximately $1,270,000[224]. - Cash used in operating activities decreased to approximately $2,361,000 in Q1 2025 from $4,815,000 in Q1 2024, a reduction of $2,454,000[226]. Cash and Equity Position - As of March 31, 2025, the company had approximately $2,247,000 in cash and cash equivalents, a decrease of approximately $1,730,000 from December 31, 2024[229]. - Stockholders' equity was below the minimum requirements for continued listing on the NYSE American, with a deficit of approximately $3.9 million as of March 31, 2025[237]. Securities and Offerings - 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[242]. - An Equity Distribution Agreement was entered into with Maxim Group LLC to issue and sell up to $3,000,000 of common stock under the Registration Statement[243]. - The company has entered into a Purchase Agreement with Atlas Sciences, LLC, committing to purchase up to $15 million of common stock over a 24-month period[254]. - As of March 31, 2025, a total of 3,082,961 shares have been issued under the Purchase Agreement for approximately $398,000 after clearing costs[264]. - The company issued 5,640,958 shares of common stock and Class A and B common warrants to a single accredited investor, with an exercise price of $0.363 per share[265]. - The company received aggregate gross proceeds of approximately $1.26 million from the issuance of 4,653,036 shares and associated warrants in a registered direct offering[272]. - The company has agreed to pay Maxim a commission of 3.0% on the aggregate gross proceeds from each sale of common stock under the Sales Agreement[246]. - The total estimated expenses for the offering, excluding compensation to Maxim, will be approximately $54,000[246]. - The company cannot sell shares below the Minimum Price that would represent more than 19.99% of the outstanding shares without stockholder approval[258]. - The initial commitment fee to Atlas was paid through the issuance of 338,600 shares of common stock, equal to 1.0% of the Commitment Amount[260]. - The Common Warrants issued in the Transactions are classified as equity within the consolidated financial statements, with proceeds allocated totaling approximately $2.5 million[270]. - The registration statement for the resale of shares issued under the Purchase Agreement was declared effective on May 1, 2024[255].

Core Insights - AIM ImmunoTech Inc. presented clinical trial data for its drug Ampligen at the Annual Meeting of the American Association of Immunologists, highlighting its potential in treating cancers and immune disorders [1][2]. Company Overview - AIM ImmunoTech Inc. is focused on developing therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19. Its lead product, Ampligen (rintatolimod), is a first-in-class investigational drug that acts as a highly selective TLR3 agonist [3]. Clinical Data Presentation - The presentation by Dr. Pawel Kalinski discussed the unique selectivity of Ampligen in promoting CTL (cytotoxic T lymphocyte) influx into the tumor microenvironment (TME) while avoiding Treg (regulatory T cell) attraction. This selectivity differentiates Ampligen from other treatments like poly-I:C [2]. - Mechanistic data indicated that Ampligen's selectivity is due to its avoidance of helicase-dependent activation of NFkB, which prevents the induction of undesirable inflammatory factors while focusing on tumor tissues [2]. CEO Commentary - The CEO of AIM ImmunoTech expressed confidence in Ampligen's potential as a therapeutic option for unmet medical needs, particularly in the context of deadly cancers [3].

Company Overview - AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19 [3] - The company's lead product is Ampligen® (rintatolimod), a first-in-class investigational drug that acts as a dsRNA and highly selective TLR3 agonist immuno-modulator, showing broad spectrum activity in clinical trials [3] Recent Developments - As of April 7, 2025, AIM's common stock is trading under the ticker AIMI on the Pink Open Market [1] - A special meeting regarding a reverse stock split is scheduled for April 30, 2025 [1] - Additional information can be found in AIM's Definitive Proxy Statement filed on April 2, 2025 [2]

Financial Data and Key Metrics Changes - As of December 31, 2024, the company had approximately $4 million in cash, cash equivalents, and marketable securities [20] - Research and development expenses for the year ended December 31, 2024, were $6.2 million, a decrease from $10.9 million for the year ended December 31, 2023 [21] - General and administrative expenses for the year ended December 31, 2024, were $13.7 million, down from $21.1 million for the year ended December 31, 2023 [21] Business Line Data and Key Metrics Changes - The company is advancing multiple clinical programs, including a Phase 2 trial for pancreatic cancer and a Phase 2 study for advanced ovarian cancer, both of which are nearing completion [14][15] - The AMP518 study for post-COVID conditions has been completed, and a follow-up study is being planned [18] Market Data and Key Metrics Changes - The company is actively evaluating options to maintain compliance with the New York Stock Exchange American listing requirements, including a potential reverse stock split [22][24] Company Strategy and Development Direction - The company is focused on advancing Ampligen across multiple areas of significant medical need, including collaborations with AstraZeneca and the University of Alabama Birmingham Medical Center [8][10] - The addition of experienced board members is expected to strengthen the company's leadership and strategic execution [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential of Ampligen to address high medical needs [19] - The company is committed to maintaining its NYSE listing, which is seen as essential for long-term success and access to capital [22] Other Important Information - The company has been granted new patents for the treatment of endometriosis and for addressing post-COVID fatigue, expanding its intellectual property estate [12] Q&A Session Summary Question: Does the company have adequate supply of Ampligen for clinical trials this year? - Management confirmed that there is a budget tied to ongoing clinical activities to ensure sufficient supply for current trials, and they do not anticipate issues unless unforeseen circumstances arise [28][30] Question: How easy would it be to obtain new supply of Ampligen? - Management indicated that while future clinical trials will require additional manufacturing of Ampligen, they are actively analyzing the process and working with manufacturers to ensure supply [30][31]