Current Report · Items 7.01, 9.01 · 8-K

AIM ImmunoTech Inc.

AIMNYSE_AMERICANEQUITYCurrent

Regulation FD Disclosure

Filed Aug 11, 2026Accepted Aug 11, 2026, 8:40 AM EDTCIK 946644Accession 0001493152-26-036996

Company context

We are focused on pancreatic cancer because testing results to date — primarily conducted in the Netherlands — have been very promising. The Netherlands study generated statistically significant data indicating that Ampligen extended survival well beyond the Standard of Care (“SOC”), when compared to well-matched historical controls. These data support the proposition that Ampligen, when administered to either patients with locally advanced or metastatic pancreatic cancer after systemic chemotherapy, showed a statistically significant increase in survival rate. In October 2021, we and our Contract Research Organization, Amarex, submitted an IND application to the FDA for a planned Phase 2 study of Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer. In December 2021, the FDA responded with a Clinical Hold on the proposed study. We submitted our response to the FDA in February 2022. In March 2022, we received notification from the FDA that the Clinical Hold was released and cleared, meaning that we are now able to proceed with the study specifically to treat locally advanced pancreatic cancer patients. In August 2022, we received IRB approval of the trial protocol and so announced the trial’s commencement. In February 2025, we made a business decision to place screening/enrollment on hold and suspend the study. The study may be redesigned or amended, pending additional data from the ongoing DURIPANC clinical trial.

Current securities

AIMNYSE_AMERICAN · EQUITY · Current

Historical securities (3)

AIMNYSE_AMERICAN · EQUITY · Historical · closed Apr 3, 2025 AIMIOTC · EQUITY · Historical · closed Jun 23, 2025 AIMIDOTC · EQUITY · Historical · closed Jun 16, 2025

Recent company filings

Disclosure sections

Items 7.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 7.01Item 7.01 - Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On August 11, 2026, the online media company Breaking Defense ( https://breakingdefense.com ) published an article authored by Thomas K. Equels, the Chief Executive Officer of AIM ImmunoTech Inc. (the “Company”). The article, titled “Biodefense is force protection: Ready today, prepared for tomorrow,” discusses the importance of military force readiness, specifically how the Company’s drug Ampligen (rintatolimod) has potential as a broad-spectrum early-onset and/or prophylactic antiviral therapeutic for Ebola virus disease. The article also discusses Ampligen’s history and potential as a broad-spectrum early-onset and/or prophylactic antiviral therapeutic in the treatment of COVID-19 and related viruses. A copy of the article is furnished as Exhibit 99.1 hereto. The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing. Cautionary Note Regarding Forward-Looking Statements This Current Report on Form 8-K, including Exhibit 99.1, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, but are not limited to, statements relating to: the potential of Ampligen as a broad-spectrum prophylactic or early-onset treatment for viral threats, including Ebola virus disease and coronaviruses; preclinical proof-of-concept findings, which are not evidence of FDA approval or clinical efficacy in humans; expectations regarding Ampligen’s mechanism of action; the timing and outcome of future clinical trials, regulatory submissions, or government funding decisions; and the Company’s business strategy and objectives. Words such as “believe,” “may,” “will,” “could,” “should,” “estimate,” “anticipate,” “intend,” “expect,” “potential,” “plan,” “project” and similar expressions identify forward-looking statements. These statements are based on current expectations and assumptions that may prove incorrect, and involve risks and uncertainties that could cause actual results to differ materially. Important factors include: uncertainties in pharmaceutical development, including the risk that preclinical results may not be replicated in clinical trials; regulatory uncertainties; dependence on government funding; limited financial resources; and competitive and market conditions. For additional risk factors, see the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC at www.sec.gov. All forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to update them except as required by law. The Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Filed exhibits (1)

EX-99.1 (by filename) ex99-1.htm

EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Biodefense Is Force Protection: Ready Today, Prepared for Tomorrow A decorated combat aviator and biotech CEO advocates preparing for novel viral threats before the next crisis. By Thomas K. Equels America treats biodefense too much like a public health backstop and not enough like military force protection. That must change. As a former Army helicopter gunship pilot who flew more than 300 combat missions, an instructor pilot and a TRADOC project officer, I learned that readiness is built before the threat appears. The people we send into danger need training, equipment, intelligence, planning and support before they are asked to take the risk. As CEO of AIM ImmunoTech, I know biological threats require the same mindset. The history of warfare teaches us that a biological event does not have to begin as an attack to create serious military consequences. A natural outbreak, accidental release or deliberate biological incident can affect deployments, base operations, shipboard readiness, homeland defense and the ability to operate in contested environments. When it is a new viral threat, the force can be exposed before commanders ha…

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