Company Description
AIM ImmunoTech Inc. (NYSE American: AIM) is an immuno-pharma company in the biological product manufacturing sector that focuses on the research and development of therapeutics for cancers, viral diseases, immune-deficiency disorders, and cancers for which there are inadequate or unmet therapies. According to company disclosures, its flagship products are Ampligen (rintatolimod) and Alferon N Injection (Interferon alfa). Ampligen is described as a double-stranded RNA (dsRNA) molecule being developed for globally important cancers, viral diseases, and immune system disorders, and it is approved for commercial sale in the Argentine Republic for the treatment of severe Chronic Fatigue Syndrome (CFS).
Core programs and therapeutic focus
The company highlights Ampligen (rintatolimod) as its lead product candidate. Information provided by AIM ImmunoTech states that Ampligen is designed to modulate the immune system and that data from in vitro, pre-clinical and clinical experiments suggest a broad-spectrum, early-onset antiviral effect through stimulation of the innate immune response. The company has reported conducting Ampligen experiments in SARS‑CoV‑1 showing a significant decrease in viral replication and has indicated that, based on the high degree of homology between SARS‑CoV‑1 and SARS‑CoV‑2 structural proteins, Ampligen may have antiviral activity relevant to Long COVID.
AIM ImmunoTech also reports clinical work in oncology. The company describes an ongoing pancreatic cancer program in which Ampligen is evaluated in combination with AstraZeneca’s anti‑PD‑L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the DURIPANC Phase 1b/2 clinical trial for metastatic pancreatic cancer. The company has also discussed a completed Phase 2 clinical study in advanced recurrent ovarian cancer conducted by the University of Pittsburgh Medical Center, in which Ampligen was combined with cisplatin and Merck’s Keytruda (pembrolizumab). In company communications, AIM notes that this combination therapy was well tolerated and demonstrated clinical benefit in that setting.
Intellectual property and international protection
AIM ImmunoTech reports an active intellectual property strategy around Ampligen. The company has disclosed that the European Patent Office granted European Patent No. 4,096,675 titled “Compositions for Treating LONG COVID,” covering compositions of matter of its proprietary dsRNAs, including Ampligen, for use in the treatment of Long COVID. The company has also announced a patent from the Japan Patent Office covering the use of Ampligen in combination with checkpoint inhibitors (anti‑PD‑1 or anti‑PD‑L1 antibodies) for the treatment of cancer, with claims that encompass multiple cancer types such as pancreatic cancer, ovarian cancer, melanoma, and others.
In addition, AIM states that it holds a U.S. patent for methods involving the use of Ampligen as part of a combination oncology therapy when paired with an anti‑PD‑L1 antibody, as well as a patent in the Netherlands for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors, including Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab). Company materials describe these patents as covering synergistic therapeutic approaches in immuno-oncology.
Clinical and scientific evidence cited by the company
The company refers to several sources of clinical and scientific evidence related to Ampligen. AIM ImmunoTech has highlighted:
- A Phase 2 trial in recurrent platinum-sensitive ovarian cancer using combination locoregional chemoimmunotherapy with intraperitoneal cisplatin, intravenous pembrolizumab and intraperitoneal Ampligen, where an abstract presented at the Society for Immunotherapy of Cancer (SITC) reported an objective response rate of 50% among evaluable patients, compared with lower response rates reported in a pembrolizumab-only study (Keynote‑100) in a similar disease context.
- A peer-reviewed article in the Journal for ImmunoTherapy of Cancer that, according to the company, provides evidence of a positive combination effect of Ampligen and interferon‑alpha on tumor growth and subsequent subject survival, and discusses systemic chemokine modulation and sensitization of “cold” tumors to PD‑1 blockade.
- A Phase 2 study (AMP‑518) evaluating Ampligen as a potential therapeutic for people with the post‑COVID condition of fatigue (Long COVID), where the company has reported positive topline results indicating that Ampligen was generally well tolerated and that efficacy results offered evidence it may reduce fatigue in subjects with post‑COVID conditions.
These data points are presented by AIM ImmunoTech as supporting its belief in Ampligen’s potential as a broad-spectrum immunotherapy and as a synergistic agent when combined with checkpoint inhibitors or other cancer treatments.
Corporate and capital markets information
AIM ImmunoTech Inc. is identified in SEC filings as a smaller reporting company. Its common stock trades on the NYSE American under the symbol AIM. The company has disclosed that trading in its shares was temporarily suspended from the NYSE American and that the shares traded on the OTC Pink under the symbol AIMID beginning April 7, 2025, before being reinstated on the NYSE American under the symbol AIM on June 17, 2025. AIM has also described actions such as a reverse stock split and various equity and rights offerings, including offerings of common stock, pre‑funded warrants, and warrants, as well as a rights offering involving Series G Convertible Preferred Stock and warrants, as part of its capital-raising activities.
In addition, the company has reported entering into a Note Purchase Agreement with an institutional investor for an unsecured promissory note, outlining terms such as original issuance discount, interest rate, maturity, mandatory prepayment provisions tied to future fundraising, and events of default. These disclosures indicate that AIM ImmunoTech uses a mix of equity and debt financing to support its operations and clinical programs.
Regulatory reporting and governance
Through its SEC filings, AIM ImmunoTech provides information on its financial reporting, governance, and shareholder matters. For example, the company filed a Form 12b‑25 notification of late filing for its Quarterly Report on Form 10‑Q for the period ended September 30, 2025, citing delays in completing the required review and the need for additional time for management to compile and verify data. In that filing, AIM indicated that it expected to file within the permitted extension period and provided estimates of changes in revenues and net loss compared with the prior year period.
The company’s proxy materials describe its status as a smaller reporting company and outline matters such as the election of directors, ratification of the independent registered public accounting firm, advisory votes on executive compensation, and the frequency of such advisory votes. AIM ImmunoTech has also reported the results of its annual meeting of stockholders, including vote tallies on director elections and advisory proposals.
Status and operations
Based on the information provided in recent news releases and SEC filings, AIM ImmunoTech continues to operate as a public company, conduct clinical research involving Ampligen in oncology and Long COVID, and manage its capital structure through offerings and financing agreements. The company has also announced a stock dividend of one share of common stock for every 1,000 shares of outstanding common stock and for certain options and warrants with rights to receive stock dividends, with details on record and distribution dates and administration by its transfer agent.
Key considerations for investors and observers
Information from AIM ImmunoTech emphasizes its focus on late-stage pancreatic cancer clinical development, combination immuno-oncology strategies, and potential applications of Ampligen in Long COVID. At the same time, SEC filings describe ongoing net losses, capital-raising transactions, and exchange listing compliance considerations. Readers interested in AIM ImmunoTech typically review its clinical data disclosures, patent portfolio, financing arrangements, and regulatory filings to understand the company’s development-stage profile and risk factors as described in its Form 10‑K, Form 10‑Q, and registration statements.