8-K
Q/C TECHNOLOGIES, INC. (QCLS)
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
Dateof Report (Date of earliest event reported): September 13, 2021
MyMDPharmaceuticals, Inc.
(Exactname of Registrant as specified in its charter)
| New Jersey | 001-36268 | 22-2983783 |
|---|---|---|
| (State or other jurisdiction<br><br> <br>of incorporation) | (Commission<br><br> <br>File No.) | (IRS Employer<br><br> <br>Identification No.) |
MyMDPharmaceuticals, Inc.
855N. Wolfe Street, Suite 623
Baltimore,MD 21205
(Addressof principal executive offices and zip code)
Registrant’stelephone number, including area code: (856) 848-8698
(Formername 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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> 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<br> of each class | Trading<br> Symbol(s) | Name<br> of each exchange on which registered |
|---|---|---|
| Common<br> stock, no par value per share | MYMD | The<br> 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 September 13, 2021, MyMD Pharmaceuticals, Inc. (the “Company”) issued a press release, attached hereto as Exhibit 99.1, announcing that it intends to initiate dosing for a Phase 2 trial of MYMD-1’s function in delaying aging early in the fourth quarter of 2021. 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 September 13, 2021 (furnished herewith pursuant to Item 7.01) |
| 104 | Cover<br> 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:<br> September 13, 2021 | By: | /s/ Chris Chapman |
| Chris<br> Chapman, M.D. | ||
| President |
Exhibit99.1
MyMDPharmaceuticals Announces Fourth Quarter 2021 Initiation of Phase 2 Clinical Trial of MYMD-1 for Extending Healthy Lifespan
Keyobjective of the trial is to reduce levels of the protein that causes inflammation and activates aging, TNF-α, in the blood
MYMD-1is designed to become the first and only FDA-approved therapeutic solution for delaying aging and prolonging lifespan
BALTIMORE, MD. – September 13, 2021 – MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage pharmaceutical company committed to extending healthy lifespan, today announced that it intends to initiate dosing for a Phase 2 trial of MYMD-1’s function in delaying aging early in the fourth quarter of 2021. Interim efficacy analysis from this study is expected in the first quarter of 2022.
The primary goal of this Phase 2 double-blind, placebo-controlled clinical trial is to achieve a reduction in the levels of tumor necrosis factor-alpha (TNF-α) in the blood. TNF-α is the protein in the body that causes inflammation and helps activate the process of aging.
“If MYMD-1 can demonstrate TNF-α reduction in the blood, our immunometabolic regulator could eventually become the first and only FDA-approved therapeutic solution for delaying aging and prolonging lifespan,” stated Chris Chapman, M.D., President, Director and Chief Medical Officer of MyMD. “MYMD-1 is designed to address massive markets, giving it the opportunity to transform major health sectors across the medical landscape.”
“Chronic inflammation is the common factor in aging and all aging-related diseases including frailty, sarcopenia (loss of muscle tissue), and autoimmunity. Since TNF-α is the master regulator of inflammation, MYMD-1’s function as a TNF-α inhibitor targets the root cause of aging, not just the symptoms,” said Adam Kaplin, M.D., Ph.D., Chief Scientific Officer. “Positive data from this important study would significantly advance MYMD-1’s potential to become a blockbuster drug for inflammation and aging.”
MYMD-1’s ease of oral dosing is a groundbreaking 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. The second and third key differentiators are selectivity and low toxicity. Unlike other therapies, MYMD-1 is designed to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not to block it from doing its normal job of being a first responder to any routine type of moderate infection. In addition, the drug is not immunosuppressive and has not been shown to cause serious side effects common with traditional therapies that treat inflammation.
Commenting on the size and scope of the market for delaying aging, Dr. Chapman added, “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 2025^1^according to a major investment bank. TNF-α blockers are the most prescribed drugs by revenue, a global market of about $40 billion per year,^2^and, according to Nature Aging journal,^3^a slowdown in aging that would increase life expectancy by one year is worth $38 trillion and by 10 years is worth $367 trillion.”
MYMD-1’s primary purpose is to slow the aging process and extend human lifespan, but it is also showing promise as a potential treatment for COVID-19-related complications, and as an anti-fibrotic and anti-prolific therapeutic. Because it can cross the blood-brain barrier, MYMD-1 is also positioned to be a possible treatment for multiple sclerosis and other brain-related disorders.
In addition to the upcoming Phase 2 aging trial, MyMD previously announced that it intends to initiate a Phase 2 trial of MYMD-1 as a therapy for COVID-19-associated depression and cytokine elevation in the fourth quarter of 2021, with initial trial data expected in the first quarter of 2022.
AboutMyMD 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 and decline rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immunometabolic system to control TNF-α, a driver of chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to treat aging and longevity, autoimmune diseases, and COVID-19- associated depression and cytokine elevation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Based on a novel synthetic derivative of cannabidiol (CBD), Supera-CBD is being developed to address 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.
^1^https://www.cnbc.com/2019/05/08/techs-next-big-disruption-could-be-delaying-death.html
^2^October 9, 2019, Tumor Necrosis Factor (TNF) Inhibitor Drugs Market, Acumen Research and Consulting
^3^Nature Aging | VOL 1 | July 2021 | p. 616–623
CautionaryStatement 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 June 30, 2021, filed by MyMD on August 16, 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.
InvestorContact:
Robert Schatz
(646) 421-9523
rschatz@mymd.com
www.mymd.com
MediaContact:
media@mymd.com