UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
Current Report
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Item 7.01 Regulation FD Disclosure.
On August 30, 2022, MyMD Pharmaceuticals, Inc. (the “Company”) issued a press release announcing a grant from the European Patent Office relating to its Supera-CBD™ product candidate. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. 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 August 30, 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: August 31, 2022 | By: | /s/ Chris Chapman |
Chris Chapman, M.D. | ||
President |
Exhibit 99.1
MYMD PHARMACEUTICALS RECEIVES GRANT FROM EUROPEAN
PATENT OFFICE FOR SUPERA-CBD™ COMPOUND
ALLOWED CLAIMS COVER SUPERA-CBD™ AS A NEW MOLECULAR ENTITY AND PHARMACEUTICAL FORMULATIONS CONTAINING THE COMPOUND
BALTIMORE, MD. – August 30, 2022 – MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD”), a clinical stage pharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, announced today that it received a decision to grant from the European Patent Office in its application no. EP 3755318 A1. The allowed claims cover MyMD’s Supera-CBD™ compound as a new molecular entity and pharmaceutical formulations containing the compound.
“We are excited that another major patent office has acknowledged the superior ability of Supera-CBD™ to selectively bind with the CB2 receptor, which could potentially offer a breakthrough drug for the treatment of indications such as pain and anxiety,” commented Chris Chapman, M.D., President, Director, and Chief Medical Officer. “This news, along with the ongoing clinical development of lead compound, MYMD-1, demonstrates the continued progress MyMD has made this year in advancing these two products.”
MYMD-1, an oral selective inhibitor of tumor necrosis factor-alpha (TNF-α), that drives chronic inflammation, is being studied to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. A Phase 2 multi-center double-blind, placebo controlled, randomized study (NCT05283486) to investigate the efficacy, tolerability and pharmacokinetics of MYMD-1 in the treatment of chronic inflammation associated with sarcopenia/frailty is currently ongoing. The company’s scientific review committee met recently and agreed to move to the next higher dose in the study.
The upcoming patent grant adds to the company’s growing portfolio that already includes patents in the US, Australia, Canada, Israel, and South Korea for Supera-CBD™ and its therapeutic uses.
About MYMD-1
MYMD-1, an oral selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation, is being studied to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection.
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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 dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation. 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 disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions.
About MyMD Pharmaceuticals, Inc.
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, 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. 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 Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022. 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.
Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@mymd.com
Media Contact:
Mike Beyer
Sam Brown, Inc.
(312) 961-2502
MikeBeyer@sambrown.com
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Cover |
Aug. 30, 2022 |
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Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | Aug. 30, 2022 |
Entity File Number | 001-36268 |
Entity Registrant Name | MyMD Pharmaceuticals, Inc. |
Entity Central Index Key | 0001321834 |
Entity Tax Identification Number | 22-2983783 |
Entity Incorporation, State or Country Code | NJ |
Entity Address, Address Line One | MyMD Pharmaceuticals, Inc. |
Entity Address, Address Line Two | 855 N. Wolfe Street |
Entity Address, Address Line Three | Suite 623 |
Entity Address, City or Town | Baltimore |
Entity Address, State or Province | MD |
Entity Address, Postal Zip Code | 21205 |
City Area Code | (856) |
Local Phone Number | 848-8698 |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
Title of 12(b) Security | Common stock, no par value per share |
Trading Symbol | MYMD |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | false |
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