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)

February 19, 2021

 

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 8.01 Other Events.

 

On February 19, 2021, we received formal notification from the European Commission (“EC”) that the European Medicines Agency (“EMA”) has designated Ampligen as an Orphan Medicinal Product (“OMP”) for treatment of pancreatic cancer. A copy of an English translation of the OMP designation from the EC is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

 

Medications that have an OMP designation by the EMA, once commercially approved in the European Union (“EU”), receive benefits including up to ten years of protection from market competition from similar medicines with similar active component and indication for use that are not shown to be clinically superior.

 

OMP designation promotes the clinical development of drugs that target rare life-threatening conditions, and which are expected to provide significant therapeutic advantage over existing treatments. An estimated 466,000 people died of pancreatic cancer worldwide in 2020, according to the World Health Organization. The five-year survival rate is only 5-10 percent.

 

According to the EMA, sponsors who obtain EMA designation “benefit from protocol assistance, a type of scientific advice specific for designated orphan medicines, and market exclusivity once the medicine is on the market.” Fee reductions are also available depending on circumstances. The EMA has a comprehensive explanation of the benefits of Orphan Drug Designation (ODD) on its website.

 

The EMA designation follows a similar approval from the U.S. Food and Drug Administration (“FDA”), which also awarded AIM with orphan drug designation status for Ampligen as a treatment for pancreatic cancer.

 

For more information please see the February 24, 2021 press release, a copy of which is furnished herewith as Exhibit 99.2.

 

Cautionary Statement

 

This Current Report on Form 8-K, including Exhibit 99.2, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act (PSLRA) of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” 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. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Orphan Medicinal Production Designation, while beneficial, does not assure commercial approval. The statistical analysis of the Erasmus study referenced in the Exhibit 99.2 was based on comparison of the patient group treated with Ampligen to a historical control group of patients with similar characteristics who were previously treated for pancreatic cancer but who did not receive Ampligen. Because these were not concurrent controls, the assignment to treatment with Ampligen was neither randomized nor blinded to the investigators or the patients. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of pancreatic cancer in humans, and no assurance can be given that it will be the case. No assurance can be given as to whether future pancreatic immuno-oncology clinical trials will be successful or yield favorable data, and the trials are subject to many factors, including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Additionally, we recognize that all cancer centers, like all medical facilities, must make the ongoing COVID-19 pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing and future studies in cancer patients because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
     
99.1   English translation of the OMP designation from the EC.
99.2   February 24, 2021 Press release.

 

 
 

 

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.
     
February 24, 2021 By: /s/ Thomas K. Equels
  Name: Thomas K. Equels
  Title:

Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

(Unofficial Translation)

 

 

EUROPEAN

COMMITTEE

 

 

Brussels, 19FEB2021

C(2021) 1285 final

 

IMPLEMENTATION DECISION OF THE COMMITTEE

 

of 19FEB2021

 

on the designation of the “Rintatolimod” medicinal product as an orphan medicinal product under (EC) Regulation No 141/2000 of the European Parliament and of the Council

 

(Text relevant to the EEA)

 

(ONLY TEXT IN THE DUTCH LANGUAGE SHALL BE CONSIDERED AS AUTHENTIC)

 

 
 

 

IMPLEMENTATION DECISION OF THE COMMITTEE

 

of 19FEB2021

 

on the designation of the “Rintatolimod” medicinal product as an orphan medicinal product under (EC) Regulation No 141/2000 of the European Parliament and of the Council

 

(Text relevant to the EEA)

 

(ONLY TEXT IN THE DUTCH LANGUAGE SHALL BE CONSIDERED AS AUTHENTIC)

 

THE EUROPEAN COMMITTEE,

 

In consideration of the Treaty on the activities of the European Union,

 

In consideration of the (EC) Regulation No 141/2000 of the European Parliament and of the Council of 16DEC1999 on orphan medicinal products 1 and in particular the first sentence of Article 5(8) thereof,

 

In consideration of the application submitted on 22SEP2020 by Hemispherx Biopharma Europe in accordance with Article 5(1) of (EC) Regulation No 141/2000,

 

In consideration of the favorable opinion from the European Medicines Agency issued by the Committee for Orphan Medicinal Products on 21JAN2021 received by the Committee on 27JAN2021,

 

In consideration of the following:

 

(1) The application submitted by Hemispherx Biopharma Europe for the “Rintatolimod” medicinal product was declared valid on 26OCT2020 in accordance with Article 5(4) of the (EC) Regulation No 141/2000.
(2) The “Rintatolimod” medicinal product meets the designation criteria in accordance with Article 3(1) of the (EC) Regulation No 141/2000.
(3) The application should therefore be accepted,

 

HAS ADOPTED THE FOLLOWING DECISION:

 

Article 1

 

The “Rintatolimod” medicinal product is designated as an orphan medicinal product for the following indication: Treatment of pancreatic cancer. It is entered in the Community Register of Orphan Medicinal Products under the following number EU/3/21/2403.

 

Article 2

 

The European Medicines Agency shall make the opinion of the Committee for Orphan Medicinal Products covered by this decision available to all the interested parties.

 

 

1 OJ L 18 of 22JAN2000, page 1.

 

1
 

 

Article 3

 

This decision is addressed to Hemispherx Biopharma Europe, Leopold De Vriesstraat 26, 2600 Berchem, Antwerp, Belgium.

 

Concluded in Brussels, 19FEB2021

 

 

On behalf of the Committee,

 

Sandra GALLINA

Director General

 

 

 

FOR HOMONYMOUS COPY

On behalf of the Secretary General,

 

Martine DEPREZ

Director

Decision-making & Collegiality

EUROPEAN COMMITTEE

 

 

2

 

 

 

Exhibit 99.2

 

 

AIM ImmunoTech’s Subsidiary Receives Orphan Medicinal Product Designation by the European Medicines Agency for Ampligen to Treat Pancreatic Cancer

 

Ocala, Fla. — February 24, 2021 — AIM ImmunoTech Inc. (NYSE American: AIM) today announced that its subsidiary, NV Hemispherx Biopharma Europe, has received formal notification from the European Commission (EC) approving the company’s Orphan Medicinal Product Application for Ampligen as a treatment for pancreatic cancer.

 

Medications that have been designated as Orphan products by the European Medicines Agency (EMA), once commercially approved in the European Union (EU), receive benefits including up to ten years of protection from market competition from similar medicines with similar active component and indication for use that are not shown to be clinically superior.

 

AIM announced earlier this month that the Committee for Orphan Medicinal Products of the EMA had recommended that Ampligen receive the designation for pancreatic cancer. The company has now received the official approval of that designation.

 

  Prof. Casper van Eijck, M.D. Ph.D., the lead investigator for the expanded access program (EAP) for Ampligen at Erasmus Medical Center, stated, “We are pleased to report that the EMA has approved Ampligen for orphan medicinal product designation. Pancreatic cancer is the seventh leading cause of cancer-related deaths worldwide with over 458,000 worldwide cases of pancreatic cancer in 2018 alone. Despite advancements in the detection and management of pancreatic cancer, the 5-year survival rate is only 5-10%. Due to the positive and statistically significant survival results, versus historical controls, that we observed when using Ampligen in patients with locally advanced/metastatic pancreatic cancer–after systemic chemotherapy–we believe that Ampligen has the potential to be a meaningful extension of the standard of care for advanced pancreatic cancer. We are currently writing the manuscript describing the results of our study and are planning to investigate Ampligen further in the follow-up pancreatic cancer Phase 2/3 clinical trial and in a Phase 1 trial in combination with check point inhibitors at Erasmus Medical Center.”
     

Prof. Casper van Eijck, surgeon and a global

leading expert in pancreatic cancer

   

 

 
 

 

 

Kazem Kazempour, Ph.D., at Amarex Clinical Research, commented, “We are working closely with AIM in the United States to attain FDA ‘fast-track’ status, as well as possible FDA ‘breakthrough’ designations, and to obtain IND authorizations to conduct a follow-up pancreatic cancer Phase 2/3 clinical trial with sites in the Netherlands at Erasmus MC under Prof. van Eijck, and also at major cancer research centers in the United States.”

 

“Orphan medicinal product designation in the EU and in the US is a critical milestone in AIM’s ongoing efforts to develop Ampligen as a treatment for pancreatic cancer,” said AIM CEO Thomas K. Equels. “Pancreatic cancer is one of the deadliest cancers because, far too often, it is not diagnosed until Stage IV, when the disease is so far along that there are limited therapeutic options. We at AIM hope that Ampligen can one day help add precious time to the lives of many people suffering from pancreatic cancer.”  

 

Kazem Kazempour, Ph.D., CEO and

President of Amarex Clinical Research, LLC

   

 

Orphan medicinal product designations promote the clinical development of drugs that target rare life-threatening conditions, and which are expected to provide significant therapeutic advantage over existing treatments. An estimated 466,000 people died of pancreatic cancer worldwide in 2020, according to the World Health Organization. The five-year survival rate is only 5-10 percent.

 

Sponsors who obtain EMA orphan designation “benefit from protocol assistance, a type of scientific advice specific for designated orphan medicines, and market exclusivity once the medicine is on the market,” according to the EMA. Fee reductions are also available depending on circumstances. The EMA has a comprehensive explanation of the benefits of Orphan Drug Designation (ODD) on its website.

 

The EMA designation follows a similar approval from the U.S. Food and Drug Administration (FDA), which also awarded AIM with orphan drug designation status for Ampligen as a treatment for pancreatic cancer.

 

The FDA orphan designation followed the company’s September 22, 2020 announcement of statistically significant positive pancreatic cancer survival benefit in the Ampligen arm as compared to a historical control cohort seen in a multi-year Early Access Program conducted at Erasmus University Medical Center in the Netherlands. The use of Ampligen following the current standard of care for pancreatic cancer (FOLFIRINOX) yielded an overall survival of 19 months, 7.9 months greater than FOLFIRINOX treatment alone.

 

 
 

 

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 disease caused by the SARS-CoV-2 virus.

 

Cautionary Statement

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act (PSLRA) of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” 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. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Orphan Medicinal Production Designation, while beneficial, does not assure commercial approval. The statistical analysis of the Erasmus study was based on comparison of the patient group treated with Ampligen to a historical control group of patients with similar characteristics who were previously treated for pancreatic cancer but who did not receive Ampligen. Because these were not concurrent controls, the assignment to treatment with Ampligen was neither randomized nor blinded to the investigators or the patients. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of pancreatic cancer in humans, and no assurance can be given that it will be the case. No assurance can be given as to whether future pancreatic immuno-oncology clinical trials will be successful or yield favorable data, and the trials are subject to many factors, including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Additionally, we recognize that all cancer centers, like all medical facilities, must make the ongoing COVID-19 pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing and future studies in cancer patients because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks.

 

Contacts:

 

Crescendo Communications, LLC

Phone: 212-671-1021

Email: aim@crescendo-ir.com

 

AIM ImmunoTech Inc

Phone: 800-778-4042

Email: IR@aimimmuno.com