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]

Core Insights - AIM ImmunoTech Inc. is advancing its clinical development programs, particularly in high-value areas such as pancreatic cancer, with significant milestones expected in the next 18 months [1][2] Financial Highlights - As of December 31, 2024, AIM reported cash, cash equivalents, and marketable investments of $4.0 million, a decrease from $13.1 million as of December 31, 2023 [16] - Research and development expenses for the year ended December 31, 2024, were $6.2 million, down from $10.9 million in 2023 [16] - General and administrative expenses for the year ended December 31, 2024, were $13.7 million, compared to $21.1 million in 2023 [16] Upcoming Milestones - In the area of metastatic pancreatic ductal adenocarcinoma, a Phase 1b/2 trial combining Ampligen with AstraZeneca's Durvalumab is expected to enroll the last patient by Q2/Q3 2026 [4] - For refractory melanoma, a Phase 2 trial involving Ampligen is underway, with plans to study Ampligen in combination with AstraZeneca's FluMist as an intranasal vaccine for influenza [5] - A Phase 1/2a study for stage 4 triple-negative breast cancer is expected to complete enrollment by Q2 2026 [7] - In advanced recurrent ovarian cancer, a Phase 2 study is set to complete in H1 2025 [8] Company Overview - AIM ImmunoTech Inc. focuses on developing therapeutics for various cancers, immune disorders, and viral diseases, with its lead product being Ampligen, a first-in-class investigational drug [13]

Product Development and Clinical Trials - AIM ImmunoTech's flagship product, Ampligen, is currently approved for commercial sale in Argentina for the treatment of severe Chronic Fatigue Syndrome (CFS) but has not yet received FDA approval in the United States[12]. - The company is prioritizing clinical activities for pancreatic cancer, ME/CFS, and Post-COVID conditions, with a focus on trials authorized by the FDA or EMA[13]. - A Phase 2 study of Ampligen in combination with Imfinzi for late-stage pancreatic cancer has been approved by the Erasmus Medical Center Safety Committee[14]. - Interim data from a Phase 2 trial indicated that Ampligen, when combined with cisplatin and pembrolizumab, showed increased biomarkers associated with T cell chemotaxis and cytolytic function in patients with recurrent platinum-sensitive ovarian cancer[16]. - The company plans to pursue a study of a potential avian influenza combination therapy of Ampligen and AstraZeneca's FluMist, which previously showed a four-fold increase in immune response to seasonal variants[21]. - As of December 31, 2024, there were 6 patients enrolled in the AMP-511 protocol for CFS and Post-COVID conditions, with preliminary results showing a clinically significant decrease in fatigue-related measures by week 12[27]. - The ongoing clinical trials and research efforts are aimed at demonstrating Ampligen's broad-spectrum antiviral capabilities, particularly against COVID-19 and other viral diseases[20]. - AIM is working on a comprehensive follow-up with the FDA regarding the use of Ampligen as a treatment for ME/CFS, with plans for a confirmatory trial[28]. - The DURIPANC Study is a Phase 1b/2 clinical trial combining Ampligen with AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi® for late-stage pancreatic cancer, with up to 25 patients expected to be enrolled in Phase 2[81]. - The Phase 2 AMP-270 clinical trial aims to compare the efficacy of Ampligen in combination with standard care versus standard care alone for locally advanced pancreatic adenocarcinoma, with approximately 90 subjects expected to be enrolled[81]. - The Phase 1 portion of a Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer showed a significant increase in the Teff/Treg ratio, which is associated with improved sensitivity to chemo-immunotherapy[87]. - In a Phase 2 study of advanced recurrent ovarian cancer, an Objective Response Rate (ORR) of 45% was observed in platinum-sensitive subjects, with a Clinical Benefit Rate (CBR) of 55% and a median Progression-Free Survival (PFS) of 7.8 months[87]. - The Phase 1 study of early-stage triple negative breast cancer demonstrated a safety profile with 56% of patients achieving a pathological complete response (pCR)[89]. - In a study of pancreatic cancer patients treated with Ampligen, the median overall survival was reported at 19 months, significantly higher than historical controls[98]. - The FDA granted Ampligen Orphan Drug Designation for pancreatic cancer, providing seven years of exclusivity rights upon market approval[100]. - Ampligen has shown antiviral properties against coronaviruses, suggesting potential effectiveness against SARS-CoV-2, the virus causing COVID-19[101]. - The company is actively pursuing clinical trials to evaluate Ampligen as a treatment for COVID-19, based on its previous efficacy against SARS-CoV-1[103]. - A Phase 2 study for PD-1/PD-L1 resistant melanoma is underway, evaluating a combination of Ampligen and tumor-selective chemokine modulation[90]. - The Phase 1/2a trial for metastatic or unresectable triple negative breast cancer is currently recruiting subjects to assess the safety and efficacy of chemokine modulation therapy[91]. - In July 2023, the company enrolled and dosed the first patient in a Phase 2 study evaluating Ampligen as a potential therapeutic for post-COVID conditions, with a planned enrollment of 80 subjects aged 18 to 60[115]. - The Phase 1/2a study of Ampligen and interferon alpha in cancer patients with COVID-19 aims to enroll up to 44 patients, with initial results showing safety and potential efficacy[106]. - The AMP-511 Expanded Access Program clinical trial for ME/CFS was expanded to include patients with chronic fatigue-like symptoms post-SARS-CoV-2 infection[108]. - In January 2025, the final clinical study results from AMP-518 indicated significant improvement in walking distance for Ampligen-treated subjects compared to placebo, with a mean improvement of 139 meters versus 91 meters[116]. - A total of 40 healthy subjects participated in a Phase 1 randomized study assessing the safety of repeated intranasal administration of Ampligen, with no serious adverse events reported[111]. Financial Position and Market Risks - The company has suffered losses from operations and has a working capital deficit as of December 31, 2024, raising substantial doubt about its ability to continue as a going concern[44]. - Stockholders' equity was below the minimum requirements for continued listing on the NYSE American, which could lead to delisting and affect market price and liquidity[47]. - The company is in negotiations to reduce outstanding accounts payable, which could partially alleviate negative working capital, but there is no assurance of the outcome[44]. - The company has limited marketing and sales capability, which may hinder revenue generation and profitability[56]. - The company may require additional financing, which may not be available, and it continues to incur substantial losses[53]. - The market price of the company's stock may be adversely affected by market volatility and potential dilution from future fundraising efforts[61]. - The FDA has authorized an increased reimbursement level for Ampligen from $200 to $345 per 200 mg vial due to rising production costs, effective from 2021 to 2024[65]. - The company has approximately $4.0 million in cash, cash equivalents, and marketable securities, but does not generate material revenue from operations[170]. - The accumulated deficit as of December 31, 2024, was approximately $426.8 million, indicating substantial ongoing losses[172]. - The company is currently not in compliance with the Exchange's stockholders' equity rule, with stockholders' equity at a deficit of $1.3 million, below the required minimum of $6 million[156]. - A plan has been submitted to the Exchange to regain compliance by June 11, 2026, but failure to do so may result in delisting[156]. - If the common stock is delisted, it may be subject to "penny stock" rules, which could limit trading activity and liquidity[161]. - The company may seek additional funding through securities issuance, which could dilute existing ownership and negatively impact stock price[163]. - The company faces risks related to market volatility and potential litigation, which could adversely affect stock price and trading volume[165]. - The company has assets held at financial institutions that may exceed FDIC insurance limits, posing a risk to liquidity and financial condition[188]. Regulatory and Compliance Challenges - The FDA's regulatory review process for Ampligen is lengthy and uncertain, with a Complete Response Letter issued in February 2013 indicating outstanding issues[176]. - The FDA indicated that additional work is needed for Ampligen's approval, which may delay the process indefinitely and require more resources than currently available[177]. - There is significant uncertainty regarding the approval of Ampligen and Alferon N Injection, which could materially affect operations if necessary approvals are not obtained[178]. - Ampligen's development is subject to risks including potential ineffectiveness, adverse side effects, and challenges in obtaining regulatory clearances[189]. - The company has limited product liability insurance, which may expose it to significant risks from product liability claims[179]. - The company faces uncertainty regarding healthcare reimbursement for its products, which could impact commercialization efforts[181]. - The company must demonstrate the safety and efficacy of its products to obtain necessary regulatory approvals, which is a resource-intensive process[174]. Intellectual Property and Competitive Landscape - The company holds 59 patents worldwide and has 71 additional pending patent applications as of December 31, 2024, indicating a strong intellectual property position[73]. - The company has received Orphan Drug Designation from the FDA for Ampligen in the treatment of several conditions, including Chronic Fatigue Syndrome and Ebola Virus Disease[75]. - The company is focusing on expanding the market potential of Ampligen through research in immune-based disorders, including cancer and COVID-19[77]. - The patent position of biotechnology and pharmaceutical firms is highly uncertain, with no assurance that new patent applications will result in meaningful protection against competitors[201]. - The company currently licenses certain proprietary information from third parties, and there is no guarantee that these licenses can be enforced or obtained on commercially reasonable terms[202]. - There is no guarantee that trade secrets will not be disclosed or independently developed by competitors, despite confidentiality agreements with employees and consultants[203]. - Major competitors for Ampligen include Pfizer, GlaxoSmithKline, and AstraZeneca, which possess significantly greater resources and capabilities[147]. Manufacturing and Supply Chain Issues - Alferon N Injection commercial sales were halted due to lack of finished goods inventory, and FDA approvals are necessary for future operations[54]. - The production of new Alferon N Injection Active Pharmaceutical Ingredient is currently on hold, with no timeline for commercial availability[72]. - The company is exploring engaging a Contract Manufacturing Organization (CMO) to produce Alferon active pharmaceutical ingredients (API), but there is no guarantee of successful FDA pre-approval inspections[207]. - There are no long-term agreements with suppliers for essential raw materials for Ampligen, which may affect manufacturing capabilities[209]. - The company relies on a limited number of suppliers for raw and packaging materials, and any inability to secure these could significantly delay production[210]. - The sale of the old New Brunswick facility necessitated exploring a CMO for API production, and current stocks may not meet future clinical needs[211].

Core Points - AIM ImmunoTech Inc. is participating in the Virtual Investor "Top 5 for '25" On-Demand Conference, where the CEO presented five key reasons for investment interest in the company in 2025 [1][2] Group 1: Company Developments - Progress in late-stage pancreatic cancer treatment with significant advancements in the Phase 1b/2 DURIPANC trial at Erasmus Medical Center in the Netherlands [6] - Expanding research in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and post-COVID conditions, highlighting the early recognition of the link between COVID-19 and ME/CFS-like conditions [6] - Rapid advancement across the oncology pipeline with multiple key trials reaching or approaching major milestones [6] Group 2: Product Focus - Plans to advance Ampligen as a vaccine adjuvant for the growing threat of bird flu, as part of the company's antiviral priority development pipeline [6] - Ampligen's overall potential as a broad-spectrum immunotherapy [6] Group 3: Company Overview - AIM ImmunoTech Inc. is focused on the research and development of therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19, with its lead product being Ampligen (rintatolimod) [3]

Core Viewpoint - AIM ImmunoTech Inc. is initiating a clinical study to evaluate the combination of Ampligen and AstraZeneca's FluMist as an intranasal vaccine for influenza, particularly targeting avian influenza strains [1][3]. Group 1: Clinical Study Details - The planned study will follow a previous trial at the University of Alabama-Birmingham (UAB), which demonstrated that Ampligen significantly enhanced the immune response to seasonal influenza variants by over four-fold and induced cross-reactive secretory Immunoglobulin A against avian influenza strains H5N1, H7N9, and H7N3 [2]. - Paul Goepfert, MD, will serve as the Principal Investigator for the study, emphasizing the urgency due to the rising threat of avian influenza [3]. Group 2: Financial and Development Insights - AIM's CEO highlighted the potential for a cost-effective development of the vaccine combination, estimating that it would require no more than $10 million in development costs, significantly less than the billions potentially needed for new mRNA vaccines [4]. - The company is seeking funding for the study through industry or governmental grants, indicating a proactive approach to securing necessary resources [3]. Group 3: Company Background - AIM ImmunoTech Inc. is focused on developing therapeutics for various diseases, including cancers and viral infections, with Ampligen being a key investigational drug that acts as a TLR3 agonist [5].

Core Points - AIM ImmunoTech Inc. has received approval from NYSE American for its plan to regain compliance with minimum stockholders' equity requirements, with a deadline set for June 11, 2026 [1][2] - The company is focused on advancing its oncology and antiviral pipelines while executing its compliance strategy [2] Company Overview - AIM ImmunoTech Inc. is an immuno-pharma company dedicated to the research and development of 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]

Core Insights - AIM ImmunoTech Inc. has appointed David Chemerow as an Independent Director to its Board of Directors, effective immediately [1] - Mr. Chemerow has over 40 years of experience in finance, accounting, and operations across various industries, including significant roles at Comscore, Inc. and Rentrak Corporation [2] - The Chairman of AIM's Board, William Mitchell, expressed confidence in Mr. Chemerow's leadership and financial acumen, which are expected to contribute to AIM's mission [6] Company Overview - AIM ImmunoTech Inc. is focused on the research and development of therapeutics for treating cancers, immune disorders, and viral diseases, including COVID-19 [7] - The company's lead product is Ampligen (rintatolimod), a first-in-class investigational drug with broad-spectrum activity in clinical trials for significant health issues [7]