Highlights the Company’s High-Potential
Products and Pipeline
Notes the Current Board and Management Have
Presided Over Significant Outperformance Over the Past Year
Urges Stockholders to Sign, Date and
Promptly Return the WHITE Proxy Card
to Elect the Company’s Highly-Qualified Directors at the July 16th
Annual Meeting
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today
announced that it has filed its definitive proxy statement with the
U.S. Securities and Exchange Commission and sent the below letter
to stockholders. The letter has been signed by all five members of
the Company’s Board of Directors: Howard C. Birndorf, Roshawn
Blunt, Dennis J. Carlo, Ph.D., David J. Marguglio and Richard C.
Williams.
***
June 14, 2021
Dear Stockholder,
The Board of Directors (the "Board") thanks you for your
continued investment in Adamis Pharmaceuticals Corporation
("Adamis" or the "Company"). We are writing to you today because
this year's Annual Meeting of Stockholders (the "Annual Meeting")
on July 16, 2021 is an important one as Adamis continues pursuing
breakthrough drugs and treatments for allergies, respiratory
diseases and opioid-induced overdoses.
As the world continues to battle the COVID-19 pandemic and the
United States grapples with a harrowing opioid epidemic, our Board
and management are working to develop and commercialize an
innovative pipeline of sorely needed solutions. We believe our work
has the potential to not only create enduring value for
stockholders, but also society as a whole. That is why we are
urging you to vote on the WHITE
proxy card to re-elect all five members of the Board at next
month’s Annual Meeting.
Over the past year, we have been executing a disciplined and
focused strategy in order to:
- Successfully navigate the unprecedented market volatility and
operating challenges caused by the pandemic.
- Maintain a strong capital position and healthy balance
sheet.
- Pursue potential regulatory approval for our high-dose naloxone
injection product candidate, which is intended for the treatment of
opioid overdose.
- Advance Tempol, which is a potential breakthrough treatment for
COVID-19, through the clinical testing phase.
- Explore partnerships and collaborations that can help us
accelerate pipeline initiatives and potentially realize value on an
accelerated basis.
Although we recognize there is significant work in front of us
in order to deliver the value that our stockholders desire, we
believe Adamis has strong momentum heading into the back half of
2021. We have achieved total stockholder returns of more than 75%
on a one-year basis and more than 85% on a year-to-date basis.1
This represents significant outperformance relative to the Nasdaq
Biotechnology Index and the Nasdaq US Small Cap Biotechnology Index
over the same periods.
By re-electing our full Board next month, we believe
stockholders will position Adamis to sustain its momentum and
remain on a path to long-term value creation.
YOUR BOARD AND MANAGEMENT TEAM HAVE
ASSEMBLED A PRODUCT PIPELINE THAT WE BELIEVE HAS SIGNIFICANT
POTENTIAL.
It is important to underscore that Adamis has an attractive
portfolio of approved products and clinical-stage treatments. We
believe the diversity of our portfolio offers us various potential
paths to value creation for stockholders. Select highlights
include:
SYMJEPI® (epinephrine) Injection
- Since completing the transition of SYMJEPI from Sandoz in the
fourth quarter of 2020, our new commercial partner – US WorldMeds –
continues to make gains in the epinephrine market.
- In January 2021, both approved SYMJEPI products became
available through the Walgreens Prescription Savings Club at a
discounted price of $99.99 per two-pack.
- Based on third-party market data, we believe SYMJEPI unit sales
have increased approximately 90% on a year-over-year basis for the
period beginning December 2020 and ending April 2021. We attribute
much of this growth to our new partnership.
- We expect the Walgreens arrangement, along with other
commercial initiatives currently underway, to continue fueling
positive sales trends for SYMJEPI products.
ZIMHI™ (naloxone) Injection
- We announced this month that the U.S. Food and Drug
Administration (“FDA”) has accepted for review our resubmitted New
Drug Application (“NDA”) for ZIMHI, which is a higher naloxone
injection product candidate for the treatment of opioid overdose.
- We received FDA correspondence relating to the NDA, stating
that the agency had completed its filing review and had determined
that the NDA was sufficiently complete to permit a substantive
review.
- The FDA also provided a target action date under the
Prescription Drug User Fee Act of November 12, 2021.
- During the first quarter of this year, we submitted responses
to the FDA to address deficiencies identified in the complete
response letter relating to our NDA for ZIMHI. We also requested a
Type-A meeting with the agency.
- In April, we met with the FDA to discuss the responses and the
regulatory path forward for ZIMHI.
Tempol
- The National Institutes of Health (“NIH”) recently identified
the experimental drug Tempol, as a potentially potent antiviral for
COVID-19. In 2020, we in-licensed patent and related intellectual
property rights to Tempol pursuant to a license agreement for
certain fields, including 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.”2
- In February, our Investigational New Drug Application (“IND”)
relating to a protocol for a clinical trial of Tempol in COVID-19
received FDA clearance to begin clinical testing.
- We are now working with a large clinical research organization
that has started key operational aspects of the clinical study,
including site selection, site agreements and vendor
agreements.
- We are also engaged in activities intended to support preparing
an IND for a study of Tempol for the treatment of Radiation
Dermatitis.
- The manufacturer for the topical Tempol gel has been identified
and drug substance is available for manufacturing.
- Adamis is also investigating the utility of Tempol for the
treatment of cocaine and methamphetamine abuse.
- Several published studies in animals suggest that Tempol
significantly decreases the urge for both cocaine and
methamphetamines and cocaine abuse. Methamphetamine abuse is a
significant unmet public health problem that parallels the opioid
epidemic.
- According to the Centers for Disease Control, methamphetamine
use resurged in the United States from 2015 to 2018, rising to an
annual use rate of 59.7 per 1,000 adults, or approximately 14.7
million individuals per year.
While there is significant competition in the marketplace and
uncertainty always looms, we are confident that Adamis is focused
on the right assets and the right opportunities. Our Board has
several decades of experience operating at the highest levels of
the biotechnology and pharmaceuticals industries. We believe this
experience will be critical as Adamis competes and works to
accelerate clinical testing progress and prospective regulatory
approvals in the coming quarters.
ADAMIS HAS THE RIGHT LEADERSHIP FOR THIS PIVOTAL MOMENT IN
TIME
We contend that Adamis is at the precipice of major developments
and value-generating progress. This is why we believe maintaining
an aligned, experienced and stable Board is essential.
Unfortunately, Jerald A. Hammann – an opportunistic and 0.01%
stockholder with no biopharmaceutical expertise, no public company
experience and no articulated plan – has initiated costly
litigation with us and is attempting to run a slate of directors to
take control of the Board at this year’s Annual Meeting. Mr.
Hammann took these actions after we rejected his demand that Adamis
provide him a lucrative consulting agreement prior to becoming a
stockholder. We believe Mr. Hammann’s apparent track record of
launching value-destructive activist campaigns and trying to secure
what we view as greenmail should be a flashing red light for
stockholders.
If Mr. Hammann were to achieve his self-serving objective, we
believe it would be disastrous for our investors. We do not see how
Adamis would be able to build on its momentum and maintain its
valuable relationships with providers, partners and regulators if
its highly-experienced directors and presumably management were
replaced at this critical phase.
We urge stockholders seeking to realize the potential of our
pipeline to carefully consider the sizable risks posed by Mr.
Hammann’s campaign. We believe the far superior and safer path is
re-electing directors who have presided over strong momentum,
significant stock price appreciation and a viable strategy over the
past year. Our Board has a clear vision for value creation.
Once again, we thank you for your investment in Adamis. We
recognize that there have been ups-and-downs over the past several
years as the Company invested significantly in research and
development and navigated often lengthy regulatory processes.
However, we firmly believe that Adamis is on the right path now
that we have tangible pipeline momentum. We urge you to vote on the
WHITE proxy card to elect our
full five-member slate and help us sustain the Company’s
momentum.
Sincerely,
Howard C. Birndorf
Roshawn Blunt
Dennis J. Carlo, Ph.D.
David J. Marguglio
Richard C. Williams
***
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 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
recently 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 Total stock return figures run through the close of trading on
June 10, 2021. 2 National Institutes of Health, “NIH researchers
identify potential new antiviral drug for COVID-19,” June 3,
2021.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210614005430/en/
Saratoga Proxy Consulting John Ferguson / Ann Marie Mellone,
212-257-1311 jferguson@saratogaproxy.com /
amellone@saratogaproxy.com
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