Biotech News

AIM ImmunoTech Provides Routine Update on Annual Filings

AIM ImmunoTech (AIM)AIM ImmunoTechFDA / regulatory

AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today advised that its audited consolidated financial statements for the fiscal year ended December 31, 2025, contained an audit report from its independent registered public accounting firm with a going concern emphasis of matter. Release of this information is required by Section 610(b) of the NYSE American Company Guide, and does not represent any change or amendment to any of the Company’s filings for the fiscal year ended December 31, 2025.

AIM management is confident in its continued ability to raise funds based on ongoing, promising results in the development of its lead drug, Ampligen, for the treatment of late-stage pancreatic cancer. The Company recently reported positive progress in the Phase 2 clinical study evaluating Ampligen combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the “DURIPANC” study). AIM expects to release the next DURIPANC update in June 2026.

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of its lead product, Ampligen ® (rintatolimod), for the treatment of late-stage pancreatic cancer, a lethal and unmet global health problem. Ampligen is a dsRNA and highly selective TLR3 agonist immuno-modulator that has shown broad-spectrum activity in clinical trials.

Forward-Looking Statements

Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in the press release speak only as of the date of the press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The Company is in various stages of seeking to determine whether Ampligen ® will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders and disclosures in the Company’s reports filed with the SEC on its website and in its press releases set forth its current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen ® will be effective in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen ® will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Among the studies are clinical trials that provide only preliminary data with a small number of subjects, and no assurance can be given that the findings in these studies will prove true or that the study or studies will yield favorable results. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced in the Company’s reports filed with the SEC, on the Company’s website and in its press releases. No assurance can be given that intention to seek Orphan Drug Designation will result in the granting of that status, nor that the possession of Orphan Drug Designations or any patents means that a drug will receive market approval. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its potential foreign operations will not be adversely affected by these risks.

Please review the “Risk Factors” section in the Company’s latest annual report on Form 10-K and subsequent quarterly reports on Form 10-Q and the Registration Statement. Its filings are available at www.aimimmuno.com. The information found on the Company’s website is not incorporated by reference herein and is included for reference purposes only.

Related news

AIMAIM ImmunoTech2026-08-12 12:44 EST

AIM ImmunoTech CEO Highlights Biodefense and Military Force Protection in Newly Published ‘Breaking Defense’ Article

AIMAIM ImmunoTech2026-08-10 12:36 EST

AIM ImmunoTech Reports Second Quarter 2026 Financial Results and Highlights Significant Operational Execution Advancing Ampligen® Toward Planned Phase 3 Development in Pancreatic Cancer

ERASErasca2026-08-24 12:00 EST

Erasca Granted FDA Fast Track Designation for Pan-RAS Molecular Glue ERAS-0015 in Patients with Metastatic Pancreatic Adenocarcinoma

GSKGSK plc2026-08-24 07:01 EST

Jemperli (dostarlimab) accepted for priority review by the US FDA for dMMR/MSI-H locally advanced rectal cancer

REGNRegeneron Pharmaceuticals2026-08-19 17:58 EST

Pasatru™ (garetosmab-grts) First and Only FDA-approved Treatment Demonstrating Reduction in New Heterotopic Ossification (HO) Lesions and Clinician-Assessed Flare-ups in a Placebo-controlled Trial in Adults with Fibrodysplasia Ossificans Progressiva (FOP)

TEVATeva Pharmaceutical Industries2026-08-19 12:30 EST

U.S. FDA Accepts Teva’s New Drug Application (NDA) and Grants Priority Review for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Patients with Tourette Syndrome

BMYBMYBristol-Myers Squibb Company2026-08-13 21:12 EST

U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse

REPLReplimune Group2026-08-06 20:00 EST

Replimune Announces FDA Accelerated Approval of TUDRIQEVTM in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen

REPLReplimune Group2026-07-30 22:15 EST

Replimune Announces Favorable Outcome of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma

CGEMCullinan Therapeutics, Inc.2026-07-28 11:00 EST

Cullinan Therapeutics Announces Positive End-of-Phase 1 Meeting with FDA for CLN-049 and Advances Program to a Potentially Registrational Phase 2 Study in AML

AIM ImmunoTech

Immunomodulator Development AIM ImmunoTech is an immuno-pharma company developing Ampligen for oncology and selected infectious-disease applications. Its primary strategic focus is late-stage pancreatic cancer. Ampligen Ampligen, or rintatolimod, is a double-stranded RNA immunomodulator and selective TLR3 agonist. The candidate is...

Recent company news

Stock data

Close
0.26 USD
Market cap
12.04M USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States