Adamis Sends Letter to Stockholders Regarding Its Strategic Focus on Tempol as a Potentially Potent Treatment for COVID-19
June 28 2021 - 7:00AM
Business Wire
Believes Maintaining Board Continuity is
Critical to Continuing to Pursue Progress Related to Tempol
Urges Stockholders to Elect the Company’s
Highly-Qualified Directors at the July 16th Annual Meeting
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today issued
the below letter to stockholders.
June 28, 2021
Dear Stockholder,
The Board of Directors (the "Board") appreciates your continued
investment in Adamis Pharmaceuticals Corporation ("Adamis" or the
"Company"). Ahead of our Annual Meeting of Stockholders on July
16th (the "Annual Meeting"), we want to once again urge you to vote
to re-elect all five members of the Board. We believe maintaining
continuity in the boardroom is critical as Adamis focuses on
driving pipeline progress and initiating its phase 2/3 trial for
examining the effectiveness of Tempol in the treatment of
COVID-19.
We recognize that the road to value creation in the
biotechnology industry often includes detours and hurdles. Like
many other companies pursuing new drugs and treatments for complex
diseases and conditions, Adamis has certainly encountered its own
disappointments and setbacks in the course of working to develop,
secure approvals for and commercialize our products. The Board is
grateful to you for sticking with us – and we want you to know we
are listening to you and learning from your feedback.
It is equally important to stress that we believe the future is
bright for Adamis. In the near-term, we are optimistic about the
following:
- Recent research from the National Institutes of Health
(“NIH”) has identified Tempol as a potentially potent antiviral for
COVID-19. According to a study of cell cultures conducted by
NIH researchers, Tempol demonstrated an ability to limit SARS-CoV-2
infection by impairing the activity of a viral enzyme known as RNA
replicase. The NIH researchers also found that Tempol “doses used
in their antiviral studies could be likely achieved in tissues that
are the primary targets for the virus.”1
- Phase 2/3 clinical trial start-up activities are underway
for examining the effects of Tempol in the treatment of
COVID-19. Commenced activities include site identification and
initiation, data base production, vendor management, and the
establishment of an independent data safety monitoring board of
infectious disease experts, which will review the safety and
efficacy of the trial. Clinical trial drug product and placebo have
also been obtained.
- We have formed a highly-qualified Data
Safety Monitoring Board (“DSMB”) for our phase 2/3
trial. The clinical members of the DSMB include Dr.
Michael Ison (Professor, Northwestern University Feinberg School of
Medicine), Dr. Shmuel Shoham (Associate Professor, Johns Hopkins
University School of Medicine), Dr. Cameron Wolfe (Associate
Professor of Medicine, Duke University School of Medicine) and Dr.
Roy Steigbigel (Professor Stony Brook School of Medicine). The
purpose of the DSMB is to provide oversight and monitoring of the
conduct of the clinical trial, and to ensure the safety of the
participants and the validity and integrity of the study.
- We plan to begin enrolling patients in our Phase 2/3
clinical trial for Tempol in the third quarter. Following the
trial start-up activities, recent discussions with our clinical
research organization partner suggest that patient enrollment will
begin by the middle of next quarter.
- The Department of Health and Human Services recently
announced a $3 billion investment in antiviral treatments for
COVID-19. The Board and management are in the process of
evaluating how Adamis will engage with the government about
potentially participating in any federally-funded initiatives or
programs. Given that Tempol has distinct potential to serve as an
antiviral and anti-inflammatory, we believe Adamis can make a
compelling case to participate in public-private activities to
explore treatments for COVID-19.
Notably, we believe our role in trying to fight the pandemic is
becoming even more vital now that the Delta variant is rapidly
spreading across the globe. We believe our efforts related to
Tempol are providing us with a unique opportunity to pursue value
for society and our stockholders. The Board is focused on this
opportunity.
Regrettably, Jerald A. Hammann – an opportunistic holder of
1,000 shares with no biopharmaceutical expertise, no public company
experience and no articulated strategy – is continuing to wage
costly litigation and is attempting to run a slate of directors to
take control of the Board at this year’s Annual Meeting. Mr.
Hammann is doing this despite the fact that the Delaware Court of
Chancery ruled against his effort to enjoin the Company from
sending you our proxy materials, soliciting your votes and holding
our Annual Meeting as currently scheduled. We contend that Mr. Hammann’s seemingly unlawful,
disingenuous and disruptive efforts are a threat to Adamis and its
stockholders.
The Board urges stockholders to reject Mr. Hammann’s campaign of
attacks, distortions and mischaracterizations. Mr. Hammann has no
plan or relevant operating background in the biotechnology
industry. It is not the time to veer off the Company’s path and
risk undermining initiatives pertaining to Tempol and our other
product initiatives.
Once again, we thank you for your investment in Adamis. We
encourage you to vote on the WHITE
proxy card to elect our full five-member slate and help us
sustain the Company’s momentum.
Sincerely,
The Adamis Board of Directors
***
PROTECT YOUR INVESTMENT IN ADAMIS – PLEASE
SIGN, DATE AND PROMPTLY RETURN THE WHITE PROXY CARD.
The Board urges you to carefully consider
the information contained in the Company’s proxy materials and cast
your vote on the WHITE proxy card.
- DO NOT download any proxy card provided by Jerald A.
Hammann.
- DO NOT return any proxy card to Jerald A. Hammann.
- DO NOT respond to any email or phone solicitations from Jerald
A. Hammann.
CONTACT THE COMPANY’S PROXY SOLICITOR AT
INFO@SARATOGAPROXY.COM IF YOU HAVE ANY QUESTIONS REGARDING THE
ANNUAL MEETING OR HOW TO VOTE.
***
About Adamis
Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty
biopharmaceutical company primarily focused on developing and
commercializing products in various therapeutic areas, including
allergy, opioid overdose, respiratory and inflammatory disease. The
Company’s SYMJEPI (epinephrine) Injection products are approved by
the FDA for use in the emergency treatment of acute allergic
reactions, including anaphylaxis. Adamis’ naloxone injection
product candidate, ZIMHI, for the treatment of opioid overdose is
currently under FDA review. Adamis is developing additional
products, including treatments for acute respiratory diseases, such
as COVID-19, influenza, asthma, and COPD. The company’s subsidiary,
US Compounding Inc. (“USC”), compounds sterile prescription drugs,
and certain nonsterile drugs for human and veterinary use by
hospitals, clinics, surgery centers, and vet clinics throughout
most of the United States. For additional information about Adamis
Pharmaceuticals, please visit www.adamispharmaceuticals.com.
Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Such forward-looking statements include those that express
plans, anticipation, intent, contingencies, goals, targets or
future development and/or otherwise are not statements of
historical fact. These statements relate to future events or future
results of operations, including, but not limited to the following
statements: the Company’s beliefs concerning the safety and
effectiveness of Tempol and the Company’s other product candidates;
the timing of commencement or completion of any studies or trials
relating to Tempol and the availability of funding for studies or
trials; the results of any studies or trials that the Company may
conduct relating to Tempol; the Company’s ability to successfully
commercialize the products and product candidates described in this
press release, itself or through commercialization partners, and
the Company’s beliefs concerning the commercial success of its
products; future regulatory actions relating to the Company’s New
Drug Application (“NDA”) relating to its ZIMHI product; the
Company’s beliefs concerning the benefits, enforceability, and
extent of intellectual property protection afforded by patents and
patent applications that it owns or has licensed and its rights
under applicable license agreements, and its ability to enforce its
patents and other intellectual property rights against third
parties; the Company’s expectations concerning future growth;
expectations and statements about the Company’s strategies,
objectives, future goals and achievements; and other statements
concerning our future operations, activities and financial results.
These statements are only predictions and involve known and unknown
risks, uncertainties, and other factors, which may cause Adamis’
actual results to be materially different from the results
anticipated by such forward-looking statements. There can be no
assurances regarding the outcome of trials or studies relating to
Tempol or that Tempol will be found to be safe and effective in the
treatment of COVID-19 or any other indication. There can be no
assurances that future sales of SYMJEPI will meet our expectations.
There can be no assurances regarding the timing or outcome of the
FDA’s review of our resubmitted NDA relating to ZIMHI, or that the
Company will be able to successfully take any actions or develop
any additional information that the FDA may require in connection
with its review of the resubmitted NDA for ZIMHI. There can be no
assurances that the FDA will consider the Company’s responses
included in the resubmitted NDA relating to ZIMHI as satisfactory,
or that the product will be able to compete successfully in the
market if approved and launched. The Company may not achieve one or
more of the future goals described in the press release either
within the anticipated time periods or at all. In addition, as
previously disclosed, each of the Company and USC previously
received a subpoena from the U.S. Attorney’s Office for the
Southern District of New York issued in connection with a criminal
investigation. Accordingly, all forward-looking statements are
subject to the outcome of this investigation, as well as the
related investigation being conducted by the Company’s Audit
Committee. We cannot assess the impact of each factor on our
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. You should not place
undue reliance on any forward-looking statements. Further, any
forward-looking statement speaks only as of the date on which it is
made, and except as may be required by applicable law, we undertake
no obligation to update or release publicly the results of any
revisions to these forward-looking statements or to reflect events
or circumstances arising after the date of this press release.
Certain of these risks and additional risks, uncertainties, and
other factors are described in greater detail in Adamis’ filings
from time to time with the SEC, including its annual report on Form
10-K for the year ended December 31, 2020 and subsequent filings
with the SEC, which Adamis strongly urges you to read and consider,
all of which are available free of charge on the SEC's web site at
http://www.sec.gov.
1 NIH press release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210628005247/en/
Saratoga Proxy Consulting John Ferguson / Ann Marie Mellone,
212-257-1311 jferguson@saratogaproxy.com /
amellone@saratogaproxy.com
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