0001493152-24-001905.txt : 20240110 0001493152-24-001905.hdr.sgml : 20240110 20240110084512 ACCESSION NUMBER: 0001493152-24-001905 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20240110 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240110 DATE AS OF CHANGE: 20240110 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 IRS NUMBER: 520845822 STATE OF INCORPORATION: FL FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-27072 FILM NUMBER: 24524956 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 8-K 1 form8-k.htm
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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 January 10, 2024

 

AIM IMMUNOTECH INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-27072   52-0845822
(state or other jurisdiction   (Commission   (I.R.S. 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

 

AIM ImmunoTech Inc.

(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:

 

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

 

 

 

 

 

 

Item 7.01. Regulation FD Disclosure.

 

Furnished herewith as Exhibit 99.1 is a press release titled AIM ImmunoTech Announces Open Enrollment for Phase 1b/2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi (durvalumab) for the Treatment of Pancreatic Cancer. This press release references a video interview with Thomas K. Equels concerning the study, which is posted on the homepage of our website at

https://aimimmuno.com/whatthismeansvideo1/.

 

This information, including Exhibit 99.1 and the video interview, referenced herein, is “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Securities Exchange Act of 1934, as amended, or the Securities Act of 1933, as amended, if and to the extent such subsequent filing specifically references the information herein as being incorporated by reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

EXHIBIT INDEX

 

Exhibit No.   Description
     
99.1   Press release dated January 10, 2024.
     
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURES

 

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.
     
January 10, 2024 By: /s/ Thomas K. Equels

 

 

 EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

 

AIM ImmunoTech Announces Open Enrollment for Phase 1b/2 Study Evaluating

Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi®

(durvalumab) for the Treatment of Pancreatic Cancer

 

First enrollment and first subject dosing expected soon at Erasmus Medical Center in Rotterdam, Netherlands

 

Management discusses the announcement and what this means here: video

 

OCALA, Fla., January 10, 2024 / AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that enrollment is open at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen® (rintatolimod) with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of pancreatic cancer (the “DURIPANC Study”). Ampligen has shown therapeutic synergies with checkpoint inhibitors, potentially increasing survival rates and efficacy.

 

AIM announced in January 2023 that it had entered into an external sponsored collaborative clinical research agreement with Erasmus MC and AstraZeneca. The DURIPANC Study is an investigator-initiated, exploratory, open-label, single-center study with the full name “Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect.” The primary objective of the Phase 1b portion is to determine the safety of combination therapy with durvalumab and Ampligen. The primary objective of the Phase 2 portion is to determine the clinical benefit rate of the combination therapy.

 

Prof. Casper H.J. van Eijck, MD, PhD, the DURIPANC Study’s Coordinating Investigator and a pancreato-biliary surgeon at Erasmus MC, stated, “While immune checkpoint inhibitors targeting PD1/PDL1 have shown promise in other solid tumors, they have shown limited efficacy thus far in ductal cancer of the pancreas. Findings from our previous study collectively provide compelling evidence that rintatolimod treatment enhances the immune response by activating immune cells in advanced PDAC, as well as highlighting its potential synergy with ICI therapy. Therefore, we are excited about the promise of combining Ampligen with durvalumab in a clinical study and we believe this approach could make a positive impact in the current treatment landscape for patients with metastatic pancreatic cancer and extend overall and progression free survival.”

 

AIM recently received a U.S. patent for the use of Ampligen as part of a combination therapy with an anti-PD-L1 antibody.

 

AIM Chief Executive Officer Thomas K. Equels stated: “We believe that Ampligen has potential as both a monotherapy and a combination therapy, but a combination therapy could be much more enticing as a partnership or buyout target, as Ampligen would be enhancing an already approved drug in an established and successful Big Pharma market. Essentially, we are working to show that combining Ampligen treatment with an already established cancer treatment could help save even more lives.”

 

 
 

 

Hear more from Tom Equels about the significance of this news in the latest “What this Means” video.

 

The DURIPANC Study is expected to enroll up to 18 subjects in its Phase 1b portion and up to 25 patients in its Phase 2 portion. Subjects will start with Ampligen 200 mg via IV infusion twice per week for a total of 6 weeks (12 doses). Ampligen dose will be escalated to 400 mg according to a 3+3 DLT design. The first dose of Ampligen will be administered preferably 4-6 weeks after the last chemotherapy FOLFIRINOX dose. After two doses of Ampligen, the first dose of durvalumab 1500 mg via IV infusion will be introduced in week 2. Patients will continue to receive 1500 mg durvalumab via IV infusion every 4 weeks for up to a maximum of 48 weeks (up to 12 doses/cycles) with the last administration on week 48 or until confirmed disease progression according to Response Evaluation Criteria in solid Tumors (RECIST 1.1), unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

 

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 Twitter, 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. 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 (the “SEC”). 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 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

(833) 475-8247

AIM@jtcir.com

 

 

 

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Cover
Jan. 10, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Jan. 10, 2024
Entity File Number 001-27072
Entity Registrant Name AIM IMMUNOTECH INC.
Entity Central Index Key 0000946644
Entity Tax Identification Number 52-0845822
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 2117 SW Highway 484
Entity Address, City or Town Ocala
Entity Address, State or Province FL
Entity Address, Postal Zip Code 34473
City Area Code 352
Local Phone Number 448-7797
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.001 per share
Trading Symbol AIM
Security Exchange Name NYSEAMER
Entity Emerging Growth Company false

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