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Current Report · Items 1.01, 5.08, 9.01 · 8-K

AIM ImmunoTech Inc.

AIMNYSE_AMERICANEQUITYCurrent

Entry into a Material Definitive Agreement · Shareholder Director Nominations

Item 1.01 Entry into a Material Definitive Agreement. On July 31, 2026, AIM ImmunoTech Inc. (the “Company”) entered into a proposal (the “Proposal Agreement”) with Sterling Pharma Solutions (the “Manufacturer”) that is related to the Master Service Agreement and a Quality Agreement entered into between the Company and the Manufacturer in 2022.…

Filed Aug 6, 2026Accepted Aug 6, 2026, 5:22 PM EDTCIK 946644Accession 0001493152-26-036408
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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

Historical securities (3)

Recent company filings

  1. ARS filingSep 30, 2026
  2. DEF 14A filingSep 30, 2026
  3. Entry into a Material Definitive Agreement · Unregistered Sales of Equity SecuritiesSep 14, 2026
  4. Entry into a Material Definitive Agreement · Unregistered Sales of Equity SecuritiesSep 10, 2026
  5. Entry into a Material Definitive Agreement · Termination of a Material Definitive Agreement · Unregistered Sales of Equity SecuritiesSep 4, 2026

Disclosure sections

Items 1.01, 5.08, 9.01

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

Item 1.01Item 1.01 - Entry into Material Agreement
Item 1.01 Entry into a Material Definitive Agreement. On July 31, 2026, AIM ImmunoTech Inc. (the “Company”) entered into a proposal (the “Proposal Agreement”) with Sterling Pharma Solutions (the “Manufacturer”) that is related to the Master Service Agreement and a Quality Agreement entered into between the Company and the Manufacturer in 2022. Pursuant to the Proposal Agreement, the Manufacturer agreed to manufacture further batches of the polynucleotide drug substances PolyI and Poly C12U and transfer of associated test methods at the Manufacturer’s Dudley, UK location to produce the polymer precursors to manufacture the drug Ampligen. The estimated cost to the Company under the Proposal Agreement is approximately $1.5 million to be paid over a period of 12 months, as set forth in more detail in the Proposal Agreement. The Company anticipates using the manufactured product for ongoing and future clinical trials, including potentially a Phase 3 clinical trial for metastatic pancreatic cancer. The foregoing summary of the Proposal Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Proposal Agreement, which is attached as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item 5.08Item 5.08 - Shareholder Nominations
Item 5.08 Shareholder Director Nominations. Stockholders who wish to nominate a director at the Company’s 2026 annual meeting of stockholders (the “2026 Annual Meeting”), or to bring any other proposal before the 2026 Annual Meeting, that is not to be included in this year’s proxy materials pursuant to Rule 14a-8, must do so in accordance with the Company’s Restated and Amended Bylaws, which require notice be received by the Secretary at the Company’s principal executive offices not later than 5:00 p.m. local time on September 17, 2026 and not earlier than August 18, 2026. In addition to satisfying the foregoing requirements, to comply with the universal proxy rules, stockholders who intend to solicit proxies in support of director nominees other than the Company’s nominees must provide notice that sets forth the information required by Rule 14a-19 under the Exchange Act no later than October 19, 2026.

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