Akers Biosciences, Inc. (NASDAQ: AKER), today announced that its
proposed merger partner MyMD Pharmaceuticals, Inc. (“MyMD”), a
clinical stage pharmaceutical company committed to extending health
lifespan and treating immune mediated illnesses, has reached an
agreement with a major medical school to conduct a Phase 2 clinical
trial to investigate the effectiveness of MYMD-1 to treat immune
mediated depression in patients affected with COVID-19. MYMD
believes that this investigator-initiated study is the first of its
kind and addresses a significant unmet medical need.
In a finding published in JAMA Network Open on 3/12/21, it was
found that 52% of individuals who had COVID-19 had an associated
moderate to severe Major Depressive Disorder. Currently there are
no studies--to date or currently--to investigate therapeutic
approaches to treat COVID-19 associated depression that MYMD is
aware of, making this MYMD-1 study a potential landmark undertaking
to address a critical global unmet need.
The study is designed to analyze the pro-inflammatory cytokines
associated with the “cytokine storm,” with the Phase 2 trial
planned to begin in Q2, under a contract research agreement. The
COVID-19 depression trial is expected to be followed by studies at
a major medical school on the therapeutic potential of MYMD-1 in
patients with multiple sclerosis, including its effects on
depression and disease progression. MYMD-1 is believed to be the
first drug being developed to treat age related diseases and aging
itself.
“COVID-19 associated depression is just the beginning,” said
Chris Chapman, M.D., President and Chief Medical Officer of MyMD
Pharmaceuticals. “After confirming, in successful preclinical
studies over the past few years, that MYMD-1 can slow aging and
treat age-related illnesses where the immune system has gone awry,
we are excited to be moving into the clinical development phases of
this promising novel therapeutic. Because inflammation is often the
culprit for a myriad of diseases, additional studies that are
planned will include the application of MYMD-1 to treat autoimmune
diseases such as Multiple Sclerosis, delay age-related effects such
as muscle loss and frailty, and prevent the adverse effects of
space travel among Astronauts.”
About MyMD Pharmaceuticals, Inc.
MyMD is a clinical stage pharmaceutical company committed to
extending healthy lifespan by focusing on developing two
therapeutic platforms. MYMD-1 is a drug platform based on a
clinical stage small molecule that regulates the immunometabolic
system to control TNF-α and other pro-inflammatory cytokines.
MYMD-1 is being developed to treat autoimmune diseases, including
those currently treated with non-selective TNF-α blocking drugs,
and aging and longevity. SUPERA-CBD is a drug platform based on a
novel (patent pending) synthetic derivative of cannabidiol (CBD)
that targets numerous key receptors including CB2 and opioid
receptors and inhibits monoamine oxidase. SUPERA-CBD is being
developed to address the rapidly growing CBD market, that includes
FDA approved drugs and CBD products not currently regulated as a
drug. For more information, visit www.mymd.com.
No Offer or Solicitation
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No public offer of
securities shall be made except by means of a prospectus meeting
the requirements of Section 10 of the Securities Act of 1933, as
amended.
Important Additional Information for Investors and
Stockholders
In connection with the proposed transaction between Akers and
MyMD, Akers has filed with the SEC a registration statement on Form
S-4 that includes a proxy statement and prospectus of Akers. The
registration statement was declared effective by the SEC on March
23, 2021, and the proxy statement of Akers and prospectus was
mailed to the stockholders of Akers on or about March 24, 2021.
Akers may also file other relevant documents with the SEC regarding
the proposed transaction. AKERS URGES INVESTORS AND STOCKHOLDERS TO
READ THE DEFINITIVE PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT
DOCUMENTS FILED OR THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN
THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT
INFORMATION ABOUT AKERS, THE PROPOSED TRANSACTION AND RELATED
MATTERS. Investors and shareholders may obtain free copies of the
proxy statement, prospectus and other documents filed by Akers with
the SEC through the website maintained by the SEC at www.sec.gov.
In addition, investors and shareholders may obtain free copies of
the proxy statement, prospectus and other documents filed by Akers
with the SEC by contacting Investor Relations by mail at Akers
Biosciences, Inc., Attn: Investor Relations, 1185 Avenue of the
Americas, 3rd Floor, New York, New York USA 10036. Investors and
stockholders are urged to read the proxy statement, prospectus and
the other relevant materials before making any voting or investment
decision with respect to the proposed transaction.
Participants in the Solicitation
Akers and MyMD, and each of their respective directors and
executive officers and certain of their other members of management
and employees, may be deemed to be participants in the solicitation
of proxies in connection with the proposed transaction. Information
about Akers’ directors and executive officers is included in Akers’
Annual Report on Form 10-K for the year ended December 31, 2020,
filed with the SEC on March 1, 2021. Additional information
regarding these persons and their interests in the transaction is
included in the definitive proxy statement/prospectus referred to
above. These documents can be obtained free of charge from the
sources indicated above.
Cautionary Statement Regarding Forward-Looking
Statements
Certain statements contained in this communication regarding
matters that are not historical facts are forward-looking
statements within the meaning of Section 21E of the Securities and
Exchange Act of 1934, as amended, and the Private Securities
Litigation Reform Act of 1995, known as the PSLRA. These include
statements regarding management’s intentions, plans, beliefs,
expectations or forecasts for the future, and, therefore, you are
cautioned not to place undue reliance on them. No forward-looking
statement can be guaranteed, and actual results may differ
materially from those projected. Akers and MyMD undertake no
obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or otherwise,
except to the extent required by law. We use words such as
“anticipates,” “believes,” “plans,” “expects,” “projects,”
“future,” “intends,” “may,” “will,” “should,” “could,” “estimates,”
“predicts,” “potential,” “continue,” “guidance,” and similar
expressions to identify these forward-looking statements that are
intended to be covered by the safe-harbor provisions of the PSLRA.
Such forward-looking statements are based on our expectations and
involve risks and uncertainties; consequently, actual results may
differ materially from those expressed or implied in the statements
due to a number of factors, including, but not limited to, risks
relating to the completion of the merger, including the need for
stockholder approval and the satisfaction of closing conditions;
the cash balances of the combined company following the closing of
the merger; the ability of Akers to remain listed on the Nasdaq
Capital Market in connection with the merger; and expected
merger-related cash outlays, including the timing and amount of
those outlays. Risks and uncertainties related to MyMD that may
cause actual results to differ materially from those expressed or
implied in any forward-looking statement include, but are not
limited to: 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.
New factors emerge from time to time and it is not possible for
us to predict all such factors, nor can we assess the impact of
each such factor on the business or the extent to which any factor,
or combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements.
These risks, as well as other risks associated with the
combination, are more fully discussed in the definitive proxy
statement/prospectus referred to above. Additional risks and
uncertainties are identified and discussed in the “Risk Factors”
section of Akers’ Annual Report on Form 10-K, Quarterly Reports on
Form 10-Q and other documents filed from time to time with the SEC.
Forward-looking statements included in this release are based on
information available to Akers and MyMD as of the date of this
release. Neither Akers nor MyMD undertakes any obligation to update
such forward- looking statements to reflect events or circumstances
after the date of this release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210413005702/en/
Investor Contact: Brett Mass 646-536-7331 brett@haydenir.com
www.haydenir.com
Media Contact: Will Johnson 201-465-8019 MYMD@antennagroup.com
www.antennagroup.com
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