AIM ImmunoTech Reports Third Quarter 2025 Financial Results and Highlights Continued Progress Across Pipeline with Strategic Focus on Pancreatic Cancer Clinical Program

Rhea-AI Summary

AIM ImmunoTech (NYSE American: AIM) reported third quarter 2025 results and reiterated focus on advancing Ampligen as a combination therapy for pancreatic cancer.

Key items: positive mid-year safety and efficacy data from the ongoing DURIPANC trial with durvalumab; presentation of Phase 2 ovarian study data at SITC; granted a European patent for Long COVID compositions and a Japanese patent through 2039 for Ampligen plus checkpoint inhibitors; peer‑reviewed article in JITC; quarterly cash and investments of $2.4M; R&D of $607K and G&A of $1.8M; net loss $(3.3M) and an expected monthly burn of ~$550K.

Positive

• Positive DURIPANC mid‑year safety and efficacy data reported
• European patent No. 4,096,675 granted for Long COVID compositions
• Japanese patent secured for Ampligen+checkpoint inhibitors through 2039
• Peer‑reviewed evidence of Ampligen combination benefit published in JITC

Negative

• Cash and marketable investments of only $2.4M as of Sept 30, 2025
• Estimated monthly burn of ~$550K implies limited near‑term runway
• Net loss of $(3.3M) for Q3 2025 continuing operating losses
• Research and development spend fell to $607K from $1.4M (YoY)

Insights

Clinical-development and corporate finance analyst

Clinical progress and IP gains contrast with limited cash; watch the year‑end DURIPANC update and near‑term liquidity.

AIM reports continued clinical advancement for Ampligen including positive mid‑year safety and efficacy data in the DURIPANC trial combining Ampligen with durvalumab and a planned year‑end update by the end of the current quarter. The company also disclosed multiple intellectual property wins, including a European patent for Long COVID and a Japan patent through 2039, plus peer‑reviewed and conference presentations that document combination activity and program momentum.

Financially, AIM shows specific operating metrics: cash, cash equivalents and marketable investments of $2.4 million, research and development expense of $607,000 and general and administrative expense of $1.8 million for the third quarter, and a net loss from operations of $(3.3 million) (or $(1.57) per share). Management reports an expected monthly cash burn of approximately ~ $550,000. The company filed an SEC extension on November 17, 2025 and subsequently filed the Form 10‑Q.

Key dependencies and near‑term items to watch include the year‑end DURIPANC update (expected by the end of the current quarter), any disclosure of regulatory strategy toward FDA approval for a combination therapy pathway, and cash runway given the stated ~ $550,000 monthly burn versus reported $2.4 million in liquidity. Monitor upcoming public disclosures for concrete enrollment, efficacy endpoints, regulatory steps, and any financing or partnering announcements within the next 90 days that would materially affect operations.

OCALA, Fla., Nov. 18, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”), today provided a business update and reported its financial results for the third quarter 2025.

“The third quarter was marked by solid and positive clinical and operational execution. Our clinical, manufacturing and regulatory teams are heavily focused on moving Ampligen down a pathway toward eventual FDA approval as part of a combination therapy for pancreatic cancer. We recently reported positive mid-year safety and efficacy data in the ongoing DURIPANC clinical trial combining Ampligen and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi – or durvalumab – in the treatment of metastatic pancreatic cancer and, as an important inflection point, we will release a year-end update by the end of the current quarter. While we have more work ahead, the foundation we are building gives us confidence in our ability to deliver long-term value,” commented AIM Chief Executive Officer Thomas K. Equels.

Additional Recent Highlights

• Announced the presentation of data from the completed Phase 2 advanced recurrent ovarian cancer clinical study utilizing Ampligen® (rintatolimod), conducted by the University of Pittsburgh Medical Center at the 40^th Annual Society for Immunotherapy of Cancer (SITC) Meeting;
• Granted European Patent No. 4,096,675, titled “Compositions for Treating LONG COVID,” covering compositions of matter of AIM’s proprietary dsRNAs including, for example, Ampligen for use in the treatment of Long COVID;
• Secured patent in Japan through 2039 for novel cancer therapy combining Ampligen® with checkpoint inhibitors;
• Peer-reviewed article published in Journal for ImmunoTherapy of Cancer (JITC) providing evidence of a positive combination effect of Ampligen® and interferon-alpha on tumor growth and subsequent subject survival;
• Presented latest positive progress from Ampligen clinical programs in pancreatic cancer at the 5^th Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care hosted by and at Poland’s National Institute of Oncology in Warsaw, Poland.
  

For more information, please visit the Company’s website at aimimmuno.com.

Summary of Financial Highlights for Third Quarter 2025

• As of September 30, 2025, AIM reported cash, cash equivalents and marketable investments of $2.4 million.
• Research and development expenses for the three months ended September 30, 2025 were approximately $607,000, compared to $1.4 million for the same period in 2024.
• General and administrative expenses were approximately $1.8 million for the three months ended September 30, 2025, compared to $3.1 million for the same period 2024.
• The net loss from operations for the three months ended September 30, 2025 was approximately $(3.3 million), or $(1.57) per share, compared to $(3.7 million), or $(6.00) per share, for the three months ended September 30, 2024. This net loss includes non-recurring expenses. The Company expects a monthly burn rate of approximately ~ $550,000 while continuing operational efficiencies and a focused allocation of resources. This burn rate differs from the net loss above, as the net loss includes non-cash items and accounting adjustments, whereas burn rate isolates true operating cash outflows.

Please refer to the full September 30, 2025 Form 10-Q for complete details.

On November 17, 2025, AIM filed an extension with the SEC, giving the Company an additional five days to timely file its September 30, 2025 Form 10-Q. That 10-Q was subsequently filed yesterday.

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.

For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook.

Cautionary Statement:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a therapy for any indication. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

Investor Contact:

JTC Team, LLC
Jenene Thomas
908.824.0775
AIM@jtcir.com

FAQ

What did AIM (AIM) report about the DURIPANC trial on Nov 18, 2025?

AIM reported positive mid‑year safety and efficacy data from the ongoing DURIPANC trial combining Ampligen and durvalumab in metastatic pancreatic cancer and said a year‑end update will be released by quarter end.

How much cash did AIM (AIM) have at September 30, 2025 and what is the runway?

AIM reported $2.4M in cash, cash equivalents and marketable investments and stated an expected monthly burn of ~$550K, indicating limited near‑term runway.

What patents did AIM (AIM) announce in Q3 2025?

AIM announced a granted European patent No. 4,096,675 for Long COVID compositions and a Japanese patent covering Ampligen plus checkpoint inhibitors through 2039.

How did AIM's expenses change in Q3 2025 compared to Q3 2024?

R&D decreased to $607K from $1.4M and G&A declined to $1.8M from $3.1M versus the prior year quarter.

Did AIM (AIM) file its Form 10‑Q for the quarter ended September 30, 2025?

AIM filed an extension with the SEC on Nov 17, 2025 and subsequently filed the September 30, 2025 Form 10‑Q the following day.

What near‑term investor updates did AIM (AIM) promise about Ampligen?

AIM said it will release a year‑end update by the end of the current quarter regarding progress toward FDA approval pathway for Ampligen in pancreatic cancer.