0001493152-22-000404.txt : 20220105 0001493152-22-000404.hdr.sgml : 20220105 20220105092849 ACCESSION NUMBER: 0001493152-22-000404 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20220105 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220105 DATE AS OF CHANGE: 20220105 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MyMD Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001321834 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 000000000 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36268 FILM NUMBER: 22509612 BUSINESS ADDRESS: STREET 1: 855 N. WOLFE STREET STREET 2: SUITE 623 CITY: BALTIMORE STATE: MD ZIP: 21205 BUSINESS PHONE: 856-848-8698 MAIL ADDRESS: STREET 1: 855 N. WOLFE STREET STREET 2: SUITE 623 CITY: BALTIMORE STATE: MD ZIP: 21205 FORMER COMPANY: FORMER CONFORMED NAME: Akers Biosciences, Inc. DATE OF NAME CHANGE: 20170413 FORMER COMPANY: FORMER CONFORMED NAME: Akers Biosciences Inc DATE OF NAME CHANGE: 20050325 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 (Date of earliest event reported): January 5, 2022

 

MyMD Pharmaceuticals, Inc.

(Exact name of Registrant as specified in its charter)

 

New Jersey   001-36268   22-2983783
(State or other jurisdiction
of incorporation)		   (Commission
File No.)		   (IRS Employer
Identification No.)

 

MyMD Pharmaceuticals, Inc.

855 N. Wolfe Street, Suite 623

Baltimore, MD 21205
(Address of principal executive offices and zip code)

 

Registrant’s telephone number, including area code: (856) 848-8698

 

 

(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:

 

☐ 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))

 

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

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common stock, no par value per share   MYMD   The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company 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. ☐

 

 

 

 
 

 

Item 7.01 Regulation FD Disclosure.

 

On January 5, 2022, MyMD Pharmaceuticals, Inc. (the “Company”) issued a press release, attached hereto as Exhibit 99.1, announcing the issuance of a new patent. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.

 

In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (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 Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by reference in such a filing. Furthermore, the furnishing of information under Item 7.01 of this Current Report on Form 8-K is not intended to constitute a determination by the Company that the information contained herein, including the exhibits hereto, is material or that the dissemination of such information is required by Regulation FD.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit
Number		   Description
99.1   Press Release, dated January 5, 2022 (furnished herewith pursuant to Item 7.01)
104   Cover Page Interactive Data File (formatted as Inline XBRL)

 

 
 

 

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.

  MyMD PHARMACEUTICALS, INC.
     
Date: January 5, 2022 By: /s/ Chris Chapman
    Chris Chapman, M.D.
    President

 

 

 

 EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

MyMD Pharmaceuticals Announces Issuance of New U.S. Patent Covering MYMD-1 in a Method of Treating Sarcopenia

 

Expands intellectual property portfolio for lead drug candidate MYMD-1 to 3 U.S. patents related to aging and extending healthy lifespan, 16 patents in total

 

BALTIMORE, MD. – January 5, 2022 – MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage pharmaceutical company committed to extending healthy lifespan by delaying aging, announced that the U.S. Patent and Trademark Office (USPTO) awarded to the company U.S. Patent 11,219,620 B2, titled “Method of Treating Sarcopenia.” The patent will be issued on January 11, 2022.

 

“This patent issuance is rewarding and timely as we launch our Phase 2 trial of MYMD-1 as a therapy for sarcopenia, frailty, and aging, which is currently recruiting patients,” said Chris Chapman, M.D., President, Director and Chief Medical Officer of MyMD. “The issued claims protect the use of MYMD-1 in a method of treatment for the progressive and generalized loss of skeletal muscle mass and strength known as sarcopenia. Affecting up to 40% of the elderly, sarcopenia is strictly correlated with physical disability, poor quality of life and death.1

 

“We all know that aging cannot be prevented. However, aging can be delayed by targeting its mechanism of action, which is what we intend to demonstrate as MYMD-1 advances through the clinic,” Dr. Chapman added. “With our strong IP protection and clinical progression, we believe that MyMD has the potential to dominate any and all regulatory drug development for delaying aging and prolonging healthy lifespan.”

 

In the United States, the estimated cost of hospitalizations in individuals with sarcopenia is estimated at $40.4 billion,2 and the mortality rate of older adults with sarcopenia is 41% higher than those without sarcopenia.3 MyMD believes that there are no FDA-approved drugs for treating aging disorders and extending healthy lifespan in humans, a market expected to be at least $600 billion by 2025 according to a major investment bank.4

 

The latest patent adds to MyMD’s intellectual property portfolio of 16 granted patents (13 U.S. and three foreign) covering MYMD-1 in methods of reversing the normal aging process and extending lifespan, and treating chronic inflammation, autoimmune disorders, diabetes, multiple sclerosis (MS), viral infections, addictions, fibrosis, asthma, and other disorders. MyMD also holds three patents for its synthetic cannabidiol (CBD) derivative Supera-CBD. An additional 29 patent applications are pending worldwide.

 

 

1 The prevalence of sarcopenia in community-dwelling older adults, an exploration of differences between studies and within definitions: a systematic review and meta-analyses; Mayhew et al. 2019

2 Goates et al. 2019

3 Koon Yee-Lee et al. 2021

4 https://www.cnbc.com/2019/05/08/techs-next-big-disruption-could-be-delaying-death.html

 

 
 

 

In addition to the Phase 2 trial of MYMD-1 as a therapy for sarcopenia, frailty, and aging, MYMD-1’s distinct action in regulating the immune system and treating chronic inflammation is being developed for the treatment of autoimmune diseases, including rheumatoid arthritis (RA) and inflammatory bowel diseases. MyMD is in ongoing preparation with IQVIA for an Investigational New Drug (IND) and protocol for a Phase 2 study of MYMD-1 for rheumatoid arthritis in early 2022.

 

About MYMD-1

 

Originally developed for autoimmune diseases, MYMD-1’s primary purpose is to slow the aging process, prevent sarcopenia and frailty, prophylax against diseases of old age, and extend healthy lifespan. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related neurodegenerative and neuroinflammatory disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and autoimmune thyroiditis have been studied through collaborations with several academic institutions. MYMD-1 also shows promise in pre-clinical studies as a potential treatment for post- COVID-19 complications and as an anti-fibrotic and anti-proliferation therapeutic.

 

MYMD-1 has shown effectiveness in pre-clinical studies in regulating the immune system by performing as a potent inhibitor of tumor necrosis factor-alpha (TNF-α) signaling, a key driver of chronic inflammation. Unlike other anti-TNF-α therapies, MYMD-1 has been shown in these pre-clinical studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and inflammatory circumstances like cytokine storms, but not block it from doing its normal job of being a first responder to routine types of infection. MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No approved TNF inhibitor has ever been approved for oral dosing. In addition, MYMD-1 has not been shown to cause the serious side effects, common with traditional therapies that treat inflammation, even after daily dosing for a year in preclinical studies.

 

About MyMD Pharmaceuticals, Inc.

 

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases and COVID-19- associated depression. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.mymd.com.

 

 
 

 

Cautionary Statement Regarding Forward-Looking Statements

 

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021, filed by MyMD on November 12, 2021 (as amended on November 15, 2021). Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

MyMD Contact:

 

Robert Schatz

(646) 421-9523

rschatz@mymd.com

www.mymd.com

 

 

 

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