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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported):
August 21, 2023
ADAMIS
PHARMACEUTICALS CORPORATION
(Exact
Name of Registrant as Specified in Charter)
| Delaware |
|
0-26372 |
|
82-0429727 |
| (State
or other jurisdiction of incorporation) |
|
(Commission
File Number) |
|
(IRS
Employer Identification No.) |
11682
El Camino Real, Suite 300
San
Diego, CA |
|
92130 |
| (Address
of Principal Executive Offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (858) 997-2400
(Former
name or Former Address, if Changed Since Last Report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
| ☐ |
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ |
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ |
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ |
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Exchange Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on
which registered |
| Common
Stock |
|
ADMP |
|
NASDAQ Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02 |
Results of Operations and Financial Conditions |
On August 21, 2023, Adamis Pharmaceuticals Corporation
(the “Company”) issued a press release announcing certain financial results for the second quarter ended June 30, 2023. A
copy of the Company’s press release announcing this information and certain other information is attached hereto as Exhibit 99.1
and is incorporated herein by reference.
The information included in Item 2.02 (including Exhibit
99.1) of this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934 (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated
by reference in any filing under the Securities Act of 1933 or the Exchange Act, whether made before or after the date hereof, regardless
of any general incorporation language in such filing.
| Item 9.01 |
Financial Statements and Exhibits |
| Exhibit No. |
Description |
| 99.1 |
Press Release issued August 21, 2023. |
| 104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
| |
ADAMIS PHARMACEUTICALS CORPORATION |
|
| |
|
|
|
| |
|
|
|
| Dated: August
21, 2023 |
By: |
/s/ David J.
Marguglio |
|
| |
Name: |
David J. Marguglio |
|
| |
Title: |
President |
|
Adamis Pharmaceuticals Corporation 8-K
Exhibit 99.1
Adamis Pharmaceuticals Reports Second Quarter 2023
Financial Results and Provides Corporate Update
SAN DIEGO, August 21, 2023 – 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 Relations
Robert Uhl
Managing Director
ICR Westwicke
619.228.5886
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 |
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Adamis Pharmaceuticals (NASDAQ:ADMP)
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Adamis Pharmaceuticals (NASDAQ:ADMP)
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