# EDGAR Filing Document

**Accession Number:** 0000946644
**File Stem:** 0001493152-25-011441
**Filing Date:** 2025-7
**Character Count:** 19466
**Document Hash:** 261bf67c540675048be3d5aa03d917dc
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-25-011441.hdr.sgml**: 20250728

**ACCESSION NUMBER**: 0001493152-25-011441

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20250728

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250728

**DATE AS OF CHANGE**: 20250728

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** AIM ImmunoTech Inc.
- **CENTRAL INDEX KEY:** 0000946644
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 520845822
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-27072
- **FILM NUMBER:** 251153237

**BUSINESS ADDRESS:**
- **STREET 1:** 2117 SW HIGHWAY 484
- **CITY:** OCALA
- **STATE:** FL
- **ZIP:** 32801
- **BUSINESS PHONE:** 352-448-7797

**MAIL ADDRESS:**
- **STREET 1:** 2117 SW HIGHWAY 484
- **CITY:** OCALA
- **STATE:** FL
- **ZIP:** 32801

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** HEMISPHERX BIOPHARMA INC
- **DATE OF NAME CHANGE:** 19950614

?xml version='1.0' encoding='ASCII'?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 OR 15(d) of The**

**Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported) July 28, 2025**

**AIM IMMUNOTECH INC.**

(Exact name of registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| **Delaware** | **001-27072** | **52-0845822** |
| (state or other jurisdiction | (Commission | (IRS Employer |
| of incorporation) | File Number) | Identification No.) |

---

---

| | |
|:---|:---|
| **2117 SW Highway 484** **, Ocala FL** | **34473** |
| (Address of principal executive offices) | (Zip Code) |

---

Registrant's telephone number, including area code: (**352) 448-7797**

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Securities registered pursuant to Section 12(b) of the Act:

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| | |
|:---|:---|
| Title of each class | Name of each exchange on which registered |
| Common Stock, par value $0.001 per share AIM | NYSE American |

---

**Item 8.01 Other Events**

On July 28, 2025, AIM ImmunoTech Inc. (the "Company") reported positive data in a mid-year update from the ongoing Phase 2 clinical study evaluating its drug Ampligen® (rintatolimod) 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 (the "DURIPANC" study).

For more information, please see the July 28, 2025 press release which is attached to this Current Report on Form 8-K as Exhibit 99.1 and the "DURIPANC, Mid-Year Interim Clinical Progress Update" which is attached as Exhibit 99.2, both of which are incorporated by reference herein.

**Cautionary Statement Regarding Forward-Looking Statements**

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 in pancreatic cancer. 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.

**Item 9.01. Financial Statements and Exhibits.**

(d) Exhibits

The following exhibits are filed herewith:

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| | |
|:---|:---|
| Exhibit<br> Number | Description |
| 99.1 | [Press Release dated July 28, 2025](ex99-1.htm) |
| 99.2 | ["DURIPANC, Mid-Year Interim Clinical Progress Update"](ex99-2.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

**<u>SIGNATURES</u>**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | AIM ImmunoTech Inc. | AIM ImmunoTech Inc. |
| Date: July 28, 2025 | By | */s/ Thomas K. Equels*<br>|
|  |  | Thomas K. Equels, CEO |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

**AIM ImmunoTech Reports Positive Mid-year Safety and Efficacy Data from Phase 2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca's Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer**

 ****

*Mid-year report of combination therapy demonstrates promising signs of both no significant toxicity and superior PFS and OS* 

**OCALA, Fla., July 28, 2025/ <u>AIM ImmunoTech Inc</u>. (NYSE American: AIM)** ("AIM" or the "Company") today reported positive data in a mid-year update from the ongoing Phase 2 clinical study evaluating AIM's drug Ampligen® (rintatolimod) 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 (the "DURIPANC" study) (See: <u>ClinicalTrials.gov NCT05927142</u>).

The DURIPANC study — which is a joint collaboration with AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands — is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. A total of 14 subjects have been enrolled in DURIPANC as of the mid-year report. The primary objective of the study is the clinical benefit rate of the combination therapy; the secondary/exploratory objectives include assessing overall survival (OS), progression-free survival (PFS) and initiating immune-monitoring using available tissue biopsies and peripheral immune profiling.

Prof. Casper van Eijck, MD, PhD, of Erasmus MC, stated: "Our preliminary data suggests that the combination of Ampligen and durvalumab is well-tolerated in post-FOLFIRINOX pancreatic cancer patients, with encouraging preliminary survival data, especially given the historical difficulty of improving outcomes in this setting. Immunologic correlatives and further follow-up are essential to determine the biological activity and the durability of response. In addition, it will be important to identify which patients are most likely to benefit from the combination treatment, thereby personalizing therapy better and maximizing clinical outcomes."

See: *<u>DURIPANC, Mid-Year Interim Clinical Progress Update</u>*.

 

Pancreatic cancer has limited immunotherapy responsiveness, particularly in unselected populations. Following FOLFIRINOX, maintenance or second-line immunotherapies have historically shown limited survival benefit in comparison trials. Compared to these data, the DURIPANC study mid-year report shows continuing promising early signs of both no significant toxicity and superior PFS and OS:

● No significant toxicity, an encouraging safety profile for a post-chemo setting;

● ~21% of patients have PFS >6 months (3/14), with an additional 21% not yet progressed; and

● OS >6 months in the majority (64%) of eligible patients—better than expected in this setting.

AIM ImmunoTech CEO Thomas K. Equels stated: "Data from Ampligen as a maintenance monotherapy was extremely positive when compared to existing therapeutic approaches. DURIPANC builds on that foundation and these results suggest a clear path forward and identify a promising potential benefit of combining the selective innate immune activation of Ampligen with the checkpoint inhibition of durvalumab in pancreatic cancer maintenance therapy. I am hopeful that pending immune-monitoring data analysis by Prof. van Eijck and the team at Erasmus Medical Center will identify additional mechanistic insights or predictive biomarkers in this potentially groundbreaking clinical trial, bringing hope for a future therapy for this highly lethal and clearly unmet medical need that kills more than 100,000 people in the American and European Union markets each year, and more than 500,000 worldwide."

*AIM'S Pancreatic Cancer Profile*

 

The DURIPANC study is the culmination of several years of focus by AIM on the development of Ampligen for the treatment of pancreatic cancer. Since 2017, more than 50 pancreatic cancer patients received treatment with Ampligen as an immuno-oncology mono-therapy under a Dutch government-approved <u>Compassionate Use/Early Access Program</u> at Erasmus MC. Prof. van Eijck was the lead investigator and the EAP has produced a number of detailed analyses in both abstracts and peer-reviewed medical research publications:

● <u>Rintatolimod (Ampligen®) Enhances Numbers of Peripheral B Cells and Is Associated with Longer Survival in Patients with Locally Advanced and Metastasized Pancreatic Cancer Pre-Treated with FOLFIRINOX: A Single-Center Named Patient Program</u> 

● <u>Treating Pancreatic Ductal Adenocarcinoma Patients with Rintatolimod: Hitting Two Targets with One Arrow?</u> 

● <u>Rintatolimod in Advanced Pancreatic Cancer Enhances Antitumor Immunity through Dendritic Cell-Mediated T-Cell Responses</u> 

Based on these strong results suggesting Ampligen's potential effectiveness as a pancreatic cancer monotherapy, in <u>January 2023 the Company entered into Clinical Agreements</u> with AstraZeneca and Erasmus MC for the investigator-initiated DURIPANC clinical trial to study the potential combination therapy of Ampligen and Durvalumab, a PD-L1 checkpoint inhibitor.

In order to protect what has the potential to be a valuable long-term benefit for stockholders, AIM has developed an intellectual property plan specific to pancreatic cancer that includes <u>a recently issued U.S. patent for Ampligen</u> as an oncology treatment in combination with an anti-PD-L1, extending protection to August 9, 2039, as well as orphan drug designations in pancreatic cancer in both the <u>United States</u> and the <u>European Union</u> granting years of market exclusivity to AIM for Ampligen post-commercial approval.

**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 <u>aimimmuno.com</u> and connect with the Company on <u>X</u>, <u>LinkedIn</u>, and <u>Facebook</u>.

**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 in pancreatic cancer. 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 <u>AIM@jtcir.com</u>

## Exhibit 99.2

**Exhibit 99.2**

**DURIPANC, Mid-Year Interim Clinical Progress Update**

***A Phase I/II Open Label Study of Durvalumab (Imfinzi) and Rintatolimod (Ampligen) in Pancreatic Cancer Patients with Stable Disease Post-FOLFIRINOX***

*Study Title*: Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy (DURIPANC) (NCT05927142)

*Study Type*: Single-arm, exploratory, immunotherapy combination

*Population*: Metastatic pancreatic ductal adenocarcinoma (PDAC)

*Therapeutic Regimen*: Durvalumab (anti–PD-L1) + Rintatolimod (TLR3 agonist)

*Post-Chemotherapy Setting*: Stable disease after 8 cycles of FOLFIRINOX

**End Points**

The primary objective of the safety run-in (phase Ib) is to determine the safety of combination therapy with durvalumab and rintatolimod. The primary objective of the phase II trial is to determine the clinical response rate of combination therapy with durvalumab and rintatolimod. The secondary objective is to explore the immunogenic effect, assess the quality of life, and survival rates after combination therapy.

*Phase 1 – Safety study successfully completed*

**Patient Enrollment and Treatment**

● *Total Patients Enrolled to Date:* 14

● *Eligibility Criteria:* Confirmed PDAC, radiographically stable disease post-standard of care FOLFIRINOX x8 cycles, ECOG status:0–1

● *Treatment:* Durvalumab 12 doses administered once every 28 days and Rintatolimod administered twice per week for six weeks or until progression or unacceptable toxicity

**Mid-Year (Preliminary) Results (Cutoff: July 1, 2025)**

*Safety*

 

● Toxicity - No grade ≥2 immune-related or systemic toxicities reported to date

*Efficacy*

 

● Progression-Free Survival (PFS) - Among the 14 patients evaluable for progression-free survival, eight patients experienced disease progression within 6 months of treatment initiation. Three patients had a progression-free survival (PFS) duration of more than 6 months. At the time of data cutoff, 3 patients remained progression-free and were still under active follow-up.

● Overall Survival (OS) - Of the 11 patients evaluable for overall survival, seven patients (64%) achieved an overall survival (OS) duration greater than 6 months.

**Quality of Life**

Patient-reported outcomes indicated a consistently high level of quality of life (QoL) throughout the treatment period. This is particularly **notable** given that patients with advanced disease typically experience substantial symptom burden and functional decline.

In the context of a Phase I/II study, where the primary objectives often include safety, tolerability, and preliminary signals of efficacy, the preservation or improvement of quality of life serves as a critical complementary endpoint.

**Ongoing Work**

Immuno-monitoring, including paired tumor biopsies and longitudinal peripheral blood analysis, is underway and will be reported in the final analysis.

**Context and Comparison to Other Trials**

Pancreatic ductal cancer has limited immunotherapy responsiveness, particularly in unselected PDAC populations. Following FOLFIRINOX, maintenance or second-line immunotherapies have historically shown limited benefit:

● *POLO Trial (Olaparib in BRCA-mutated PDAC):* Median PFS 7.4 months vs 3.8 months (placebo), but only applicable to 5-7% of patients with germline BRCA mutations.

● *NCT02583477 (Durvalumab ± Tremelimumab post-chemotherapy)*: Minimal benefit; median PFS <2 months, no confirmed responders.

● *IMM-101 (NCT01303172)*: Added immunotherapy to chemo upfront, showed modest OS improvement (2 months), but failed to change standard of care.

Compared to these data, the DURIPANC study Mid-Year interim data shows promising early signs of no significant toxicity and encouraging PFS and OS:

● **No significant toxicity**, an encouraging safety profile for a post-chemo setting

● **21% of patients** have PFS >6 months (3/14), with **an additional 21%** not yet progressed

● **OS >6 months** in the majority (64%) of eligible patients—potentially better than expected in this setting

While the cohort remains small and non-randomized, these results suggest potential benefit of combining innate immune modulation by Rintatolimod (Ampligen) in combination with checkpoint inhibition by Durvalumab (Imfinzi) in PDAC following FOLFIRINOX standard of care chemotherapy. Pending immune-monitoring data may elucidate mechanistic insights and identify predictive biomarkers to identify patients most likely to benefit from combination therapy.

**Conclusions and Next Steps**

● Durvalumab (Imfinzi) + Rintatolimod (Ampligen) is **well-tolerated** in post-FOLFIRINOX PDAC patients

● Preliminary survival data are **encouraging**, especially given the **historical difficulty of improving outcomes in this setting** 

● Immunologic correlatives and further follow-up are **essential** to determine the biological activity and durability of response

A final report will follow with complete immunologic analyses and updated survival data.