Adamis Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Corporate Update
21 Agosto 2023 - 8:15AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a
commercial-stage biopharmaceutical company, today announced
financial results for the second quarter ended June 30, 2023, and
provided an update on recent corporate developments.
Q2 2023 Corporate Highlights
- In May, the Company closed the
merger with DMK Pharmaceuticals Corporation (DMK), a private,
clinical-stage biotechnology company at the forefront of
endorphin-inspired drug design focused on developing novel
treatments for opioid use disorder and other neuro-based diseases.
Ebrahim Versi, MD, PhD, CEO of DMK, was named CEO of Adamis and
Chairman of the Board of Directors. David J. Marguglio, previously
Chief Executive Officer of Adamis, assumed the role of President
and Chief Operating Officer of the combined company. Changes to the
composition of the Board of Directors were also made.
- In June, management participated in
the White House Roundtable with Opioid Reversal Product
Manufacturers hosted by White House Office of National Drug
Control Policy Director, Dr. Rahul Gupta, White House Domestic
Policy Council Advisor Neera Tanden, U.S. Assistant
Secretary for Health Admiral Rachel Levine,
and U.S. Assistant Secretary for Mental Health and
Substance Use Dr. Miriam E. Delphin-Rittmon. While in
Washington, D.C., management also met individually with 12 members
and/or staff of the House of Representatives and Senate, from both
parties, and discussed the opioid crisis and potential ways it
could be mitigated.
- Also in June, the Company announced
that its wholly owned subsidiary DMK was the recipient of a
grant from the National Institute of Alcohol Abuse and Alcoholism
(NIAAA) of the National Institutes of Health (NIH) to
support the development of a novel bifunctional small molecule for
the treatment of alcohol use disorder.
- In July, the Company committed to an
unrestricted research grant to the Leiden University Medical Center
Anesthesia and Pain Research Unit, to fund a ZIMHI® clinical study
by Albert Dahan, MD, PhD, a world expert on opioid-induced
respiratory depression, otherwise known as an opioid overdose. The
objective of the work will be to assess the efficacy of the
Company’s ZIMHI product compared to 4mg of intranasal naloxone,
which is comparable to NARCAN®, and the respective number of doses
required to reverse fentanyl-induced respiratory depression.
Recent Corporate Updates
- On August 4, 2023, the Company announced the closing of a
public offering of 5,930,000 units at a public offering price of
$1.35, with each unit consisting of one share of common stock (or
pre-funded warrant in lieu thereof) and one warrant to purchase one
share of common stock. The Company received gross proceeds of
approximately $8.0 million before deducting fees and other
estimated offering expenses at the closing, and has received
additional proceeds resulting from exercises after the closing date
of some of the warrants issued in the transaction.
Q2 2023 Financial Highlights
- Revenues for the second quarter ending June 30, 2023 were $0.0
million compared to $0.0 million for the same period in 2022.
Revenues were negligible in both periods because no manufacturing
of commercial products occurred in the second quarter in 2023 or
2022. Revenues for the six months ending June 30, 2023 and 2022
were approximately $1.5 million and $1.2 million, respectively. The
increase was due to higher manufacturing demand for ZIMHI in the
first quarter of 2023 versus 2022.
- Selling, general and administrative (SG&A) expenses for the
three months ending June 30, 2023 were $4.0 million compared to
$4.2 million for the second quarter of 2022. SG&A expenses for
the first six months ending June 30, 2023 and 2022 were $8.8
million and $7.6 million, respectively. The increase was primarily
attributable to approximately $1.3 million in transaction costs
associated with the DMK merger.
- Research and development (R&D) expense for the second
quarter of 2023 was $0.4 million compared to $3.2 million in the
second quarter of the prior year. R&D expense for the first six
months of 2023 was $1.7 million, compared to $7.5 million in the
same period in 2022. The decline in both periods was due to
terminating the clinical development activity related to a previous
product candidate.
- Net loss for the combined (continued and discontinued)
operations for the second quarter of 2023 was $8.6 compared to a
net loss of $8.4 million in the second quarter of 2022. The
increase was primarily attributable to a charge of $6.5 million for
DMK’s in-process research and development acquired in the merger.
Net loss for the six months ended June 30, 2023 and 2022 was $17.5
million and $18.8 million, respectively.
- Cash and cash equivalents as of June 30, 2023, were
approximately $0.6 million. Additional cash infusions subsequent to
the close of the second quarter include net proceeds of
approximately $1.8 million from the sale of assets related to the
discontinued US Compounding operations and net proceeds of
approximately $7.0 million from the Company’s equity financing
transaction that occurred in August.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a commercial stage
neuro-biotech company primarily focused on developing and
commercializing products for the treatment of opioid overdose and
substance use disorders. Adamis’ commercial products approved by
the FDA include ZIMHI® (naloxone) Injection for the treatment of
opioid overdose, and SYMJEPI® (epinephrine) Injection for use in
the emergency treatment of acute allergic reactions, including
anaphylaxis. Following its recent merger transaction with DMK
Pharmaceuticals, the Company is also developing novel therapies for
opioid use disorder (OUD) and other important neuro-based
conditions where patients are currently underserved. The Company’s
lead clinical stage product candidate, DPI-125, is being studied as
a potential novel treatment for OUD. Adamis also plans to develop
the compound for the treatment of moderate to severe pain. The
Company’s other development stage product candidates include
DPI-221 for bladder control problems and DPI-289 for severe end
stage Parkinson’s disease. For additional information about Adamis
Pharmaceuticals, please visit our website and follow us on Twitter
and LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements are identified by terminology such
as “may,” “should,” “expects,” “plans,” “anticipates,” “could,”
“intends,” “target,” “projects,” “contemplates,” “believes,”
“estimates,” “predicts,” “potential” or “continue” or the negative
of these terms or other similar words. 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 statements concerning the following matters: (i)
the commencement, timing and results of the proposed study to
conducted by Dr. Dahan regarding the Company’s ZIMHI® product; (ii)
the outcome of any current legal proceedings or future legal
proceedings; (iii) whether the combined business of DMK and Adamis
will be successful; (iv) whether any DMK product candidates will be
successfully developed or commercialized; (v) the Company’s ability
to regain compliance with Nasdaq listing standards so that the
Company’s Common Stock continues to be listed on the Nasdaq Capital
Market; (vi) the Company’s ability to raise capital to continue as
a going concern; and (vii) those risks detailed in Adamis’ most
recent Annual Report on Form 10-K and subsequent reports filed with
the Securities and Exchange Commission (“SEC”), as well as other
documents that may be filed by Adamis from time to time with the
SEC. 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. Accordingly, you
should not rely upon forward-looking statements as predictions of
future events. Adamis cannot assure you that the events and
circumstances reflected in the forward-looking statements will be
achieved or occur, and actual results could differ materially from
those projected in the forward-looking statements. Factors that
could cause actual results to differ materially from management’s
current expectations include those risks and uncertainties relating
to: our ability to raise capital; the timing and results of the
study to be conducted by Dr. Dahan; our ability to maintain
continued listing of the Common Stock on the Nasdaq Capital Market;
risks associated with development of DMK’s drug product candidates;
our cash flow, cash burn, expenses, obligations and liabilities;
the outcomes of any litigation, regulatory proceedings, inquiries
or investigations that we are or may become subject to; and other
important factors discussed in the Company’s filings with the SEC.
If we do not obtain additional equity or debt funding in the
future, our cash resources will be depleted and we could be
required to materially reduce or suspend operations, which would
likely have a material adverse effect on our business, stock price
and our relationships with third parties with whom we have business
relationships, at least until additional funding is obtained. If we
do not have sufficient funds to continue operations or satisfy out
liabilities, we could be required to seek bankruptcy protection or
other alternatives to attempt to resolve our obligations and
liabilities that could result in our stockholders losing most or
all of their investment in us. 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, 2022, 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 website at
http://www.sec.gov.
Contact:Adamis Investor RelationsRobert UhlManaging DirectorICR
Westwicke619.228.5886
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES |
|
CONSOLIDATED
BALANCE SHEET DATA (Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
June 30, 2023 |
|
December 31, 2022 |
|
Cash and
Cash Equivalents |
|
$ |
640,254 |
|
|
$ |
1,081,364 |
|
|
Total
Current Assets |
|
|
3,450,698 |
|
|
|
9,272,150 |
|
|
Total
Assets |
|
|
4,749,150 |
|
|
|
10,930,840 |
|
|
Total
Liabilities |
|
|
16,244,476 |
|
|
|
11,581,605 |
|
|
Accumulated
Deficit |
|
|
(322,081,115 |
) |
|
|
(304,564,086 |
) |
|
Total
Stockholders’ Equity |
|
|
(11,825,326 |
) |
|
|
(808,068 |
) |
|
ADAMIS
PHARMACEUTICALS CORPORATION AND SUBSIDIARIES |
CONSOLIDATED
STATEMENTS OF OPERATIONS DATA (Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended June 30, |
|
Six Months
Ended June 30, |
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue,
net |
$ |
6,945 |
|
|
$ |
39,847 |
|
|
$ |
1,459,945 |
|
|
|
1,194,361 |
|
Cost of
Goods Sold |
|
361,394 |
|
|
|
689,178 |
|
|
|
2,149,461 |
|
|
|
2,152,760 |
|
Selling,
General and Administrative Expenses |
|
4,033,083 |
|
|
|
4,205,934 |
|
|
|
8,815,168 |
|
|
|
7,588,630 |
|
Research and
Development |
|
376,957 |
|
|
|
3,320,654 |
|
|
|
1,687,486 |
|
|
|
7,542,179 |
|
Acquired
In-Process Research and Development |
|
6,539,675 |
|
|
|
- |
|
|
|
6,539,675 |
|
|
|
- |
|
Loss from
Operations |
|
(11,304,164 |
) |
|
|
(8,175,919 |
) |
|
|
(17,731,845 |
) |
|
|
(16,089,208 |
) |
Total Other
Income (Expense), net |
|
4,300,773 |
|
|
|
(159,535 |
) |
|
|
1,713,846 |
|
|
|
(2,436,000 |
) |
Net Loss
from Continuing Operations, before taxes |
|
(7,003,391 |
) |
|
|
(8,335,454 |
) |
|
|
(16,017,999 |
) |
|
|
(18,525,208 |
) |
Net Income
(Loss) from Discontinued Operations, before taxes |
|
(1,570,731 |
) |
|
|
(61,767 |
) |
|
|
(1,499,030 |
) |
|
|
(226,628 |
) |
Net Loss
Applicable to Common Stock |
$ |
(8,574,122 |
) |
|
$ |
(8,397,221 |
) |
|
$ |
(17,517,029 |
) |
|
$ |
(18,751,836 |
) |
Basic &
Diluted Loss Per Share |
$ |
(3.40 |
) |
|
$ |
(3.92 |
) |
|
$ |
(7.43 |
) |
|
$ |
(8.77 |
) |
Basic &
Diluted Weighted Average Shares Outstanding |
|
2,569,400 |
|
|
|
2,140,224 |
|
|
|
2,378,006 |
|
|
|
2,138,816 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Adamis Pharmaceuticals (NASDAQ:ADMP)
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