● Immunotherapies focused on age-related disorders and
autoimmune diseases entering Phase 2 clinical trials
● Lead molecule MYMD-1 inhibits production of tumor necrosis
factor alpha (TNF-α), a cell signaling protein involved in
systemic inflammation, in preclinical studies
● Entered into Securities Purchase Agreement for $18M private
placement of common stock and warrants priced at-the-market under
Nasdaq Rules
MyMD Pharmaceuticals, Inc. (“MyMD”) and Akers Biosciences, Inc.
(“Akers”) (NASDAQ: AKER) today jointly announced that they have
entered into a definitive merger agreement. Upon closing the
transaction, the combined company is expected to be renamed MyMD
Pharmaceuticals, Inc. and remain listed on the Nasdaq under the new
ticker symbol “MYMD.”
The companies plan to hold a video conference for investors on
Wednesday, November 18, 2020 at 4:15 p.m. ET to provide additional
context on the integrated company, the clinical pipeline and drug
development plan, and the commercial potential of the targeted
indications. To participate in the briefing session, please click
on the link below to register.
- Event Link:
https://www.webcaster4.com/Webcast/Page/2584/38815
- Participant Dial In: Toll Free: 877-407-0778; International:
201-689-8565
Following the merger, the two companies will join as one to
focus on developing and commercializing MyMD’s novel immunotherapy
pipeline assets, including MYMD-1, a first-in-class drug being
developed to treat autoimmune and age-related diseases, including
extending the human lifespan. MYMD-1 has been shown to be effective
in regulating the immune system from causing age-related diseases
in preclinical studies and MyMD believes that it is the first oral
small molecule regulator of tumor necrosis factor alpha (TNF-α)
capable of crossing the blood-brain barrier. Looking forward, MyMD
intends to also continue to develop its second asset, SUPERA-1R, a
drug platform based on a patent-protected, synthetic derivative of
cannabidiol (CBD) that seeks to target key cannabinoid
receptors.
A Phase 1 study on MYMD-1 has been completed, with plans to
begin two Phase 2 clinical trials in Q1 2021 and additional Phase 2
clinical trials throughout 2021. Preclinical data, showing the
effectiveness of MyMD-1 in treating autoimmune diseases, were
compiled by nationally recognized researchers and laid the
foundation for the studies, securing peer-reviewed publications in
The Journal of Immunology and the Journal of Neuroimmunology.
“Over the last seven years, MyMD has advanced its robust drug
development program, achieving very encouraging preclinical and
Phase 1 clinical data,” said Chris Chapman, M.D., Chief Medical
Officer of MyMD. “As we enter Phase 2 clinical trials and continue
to advance our drug candidates toward commercialization--we believe
this merger is the natural next step for us. Gaining access to the
public capital markets, along with Akers’ capital resources, should
allow us to accelerate our plans and elevate MyMD within the
emerging fields of aging, immunometabolic regulation and TNFα
inhibition.”
The mechanism of action for MYMD-1 involves shutting down the
production of TNF-α, offering the potential to reshape clinical
guidelines and treatment approaches for aging and a number of
autoimmune diseases including diabetes, rheumatoid arthritis and
multiple sclerosis.
Reflecting on the rationale for the merger, Chris Schreiber,
Executive Chairman and President of Akers, stated, "We are excited
about this strategic opportunity to focus on MyMD’s promising
clinical development program and worldwide patent position. Through
this transaction, the company will be committed to delivering
novel, multi-indication platform drugs designed to extend healthy
lifespan and treat the source of chronic autoimmune diseases. We
are highly excited about MyMD’s broad development program focused
on two drug platforms that address enormous market potential. We
believe that our merger with MyMD should provide us with additional
value creation opportunities, in addition to our COVID-19 vaccine
candidate that we have been working with our partners in India to
develop.”
Management and Organization
The combined company will be led by Chris Chapman, M.D., who
will become President and Chief Medical Officer of MyMD, and Adam
Kaplin, M.D., who will become Chief Scientific Officer of MyMD, and
is planned to be headquartered in Baltimore, Maryland. Dr. Chapman
is the founder and CEO of Chapman Pharmaceutical Consulting Inc.
and will bring extensive experience working with biotechnology
companies in the design of clinical trial protocols, conducting
clinical trials and advising on regulatory and medical affairs. Dr.
Kaplin, the prior founder and chief of the Neuropsychiatric CNS
Autoimmune Consultation Clinic, at the Johns Hopkins Multiple
Sclerosis Center of Excellence, and an assistant professor of
psychiatry and behavioral sciences at the Johns Hopkins University
School of Medicine, has consulted with multiple hospitals,
biotechnology companies and non-profit organizations on medical and
development matters.
Transaction Details
On a pro forma basis and based upon the number of shares of
Akers common stock to be issued in the merger, current Akers’
shareholders will own approximately 20% of the combined company, on
a fully diluted basis, and current MyMD’s shareholders will own
approximately 80% of the combined company on a fully diluted basis
(excluding the effect of warrants issued in the below described
private placement). The merger agreement also provides for
additional contingent payments in cash and shares to the
stockholders of MyMD under certain circumstances. The merger is
expected to close in the first half of 2021, subject to the
approval of Akers’ shareholders at a special shareholder meeting,
as well as other customary closing conditions.
In connection with the definitive merger agreement, Akers agreed
to loan MyMD up to $3 million pursuant to a secured promissory
note. The note bears interest at 5% per annum, has a maturity date
of April 15, 2022 and is secured by a first lien on MyMD’s
assets.
Private Placement
Concurrently with the execution of the merger agreement with
MyMD, Akers entered into a securities purchase agreement with
certain accredited investors to raise $18 million through the
issuance of up to 9,765,933 shares of common stock (or common stock
equivalents) and accompanying warrants to purchase an aggregate of
up to 9,765,933 shares of common stock at $1.85 per share of common
stock and accompanying warrant. The warrants are immediately
exercisable at an exercise price of $2.06 per share, with an
expiration date of five and one-half years after the date of
issuance. The offer and sale of the foregoing securities are being
made in a transaction not involving a public offering and have not
been registered under the Securities Act of 1933, as amended (the
"Securities Act"), or applicable state securities laws.
Accordingly, the securities may not be reoffered or resold in
the United States except pursuant to an effective registration
statement or an applicable exemption from the registration
requirements of the Securities Act and such applicable state
securities laws.
Under an agreement with the investors, the Company is required
to file a registration statement with the Securities and Exchange
Commission covering the resale of the shares of common stock to be
issued to the investors and to use best efforts to have the
registration statement declared effective as promptly as practical
thereafter.
The closing of the private placement is subject to the
satisfaction of certain customary closing conditions set forth in
the securities purchase agreement.
About Akers Biosciences Inc.
Akers Biosciences is pursuing rapid development and
manufacturing of a COVID-19 vaccine candidate in collaboration with
Premas Biotech PVT Ltd.
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 TNF-α blocking drugs, and aging and
longevity. SUPERA-1R 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-1R 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 Will be Filed with the
SEC
In connection with the proposed transaction between Akers and
MyMD, Akers intends to file relevant materials with the SEC,
including a registration statement that will contain a proxy
statement and prospectus. AKERS URGES INVESTORS AND STOCKHOLDERS TO
READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY
BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION
ABOUT AKERS, THE PROPOSED TRANSACTION AND RELATED MATTERS.
Investors and shareholders will be able to obtain free copies of
the proxy statement, prospectus and other documents filed by Akers
with the SEC (when they become available) through the website
maintained by the SEC at www.sec.gov. In addition, investors and
shareholders will be able to 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, 201 Grove Road, West Deptford, NJ
08086. Investors and stockholders are urged to read the proxy
statement, prospectus and the other relevant materials when they
become available 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, 2019,
filed with the SEC on March 25, 2020, as amended on October 21,
2020, and the proxy statement for Akers’ 2020 annual meeting of
stockholders, filed with the SEC on July 29, 2020. Additional
information regarding these persons and their interests in the
transaction will be included in the proxy statement relating to the
transaction when it is filed with the SEC. 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;
Aker’s inability to consummate the private placement; 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, will be more fully discussed in the proxy
statement/prospectus that will be included in the registration
statement that will be filed with the SEC in connection with the
proposed transaction. 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/20201112005624/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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