DMK Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update
14 11월 2023 - 9:30PM
DMK Pharmaceuticals Corporation (NASDAQ: DMK), a commercial
stage neuro-biotech company primarily focused on developing and
commercializing products to combat the fentanyl and substance use
disorder crises, today announced financial results for the third
quarter ended September 30, 2023, and provided an update on recent
corporate developments.
“Over the last several months, DMK has developed a holistic
company growth strategy, focused on identifying and removing
historic operational barriers to position the company for
long-term, sustained growth,” said Eboo Versi, M.D., Ph.D., CEO of
DMK Pharmaceuticals. “The change in the company name to DMK
Pharmaceuticals Corporation and the new executive team are the
first steps in this process. To that end, our newly appointed
executives are highly skilled and passionate, bringing together a
unique combination of expertise in drug development, medical
marketing, fiscal prudence and sound legal oversight. We are now in
a position t implement a series of changes that are designed to
increase revenues and to break through the boundaries of currently
available therapies that are inadequate for today’s substance use
disorder challenges.”
Q3 2023 Corporate Highlights
- In July, the Company committed to an unrestricted research
grant to the Leiden University Medical Center Anesthesia and Pain
Research Unit, to fund a clinical study for DMK’s lead product,
ZIMHI®, led by Albert Dahan, M.D., Ph.D., a world expert on
opioid-induced respiratory depression, the cause of death following
an opioid overdose. Dr. Dahan had previously performed a similar
study sponsored by the FDA to examine the efficacy of the generic
equivalent of NARCAN®. The DMK research study is designed to
evaluate the efficacy of ZIMHI®, intramuscular naloxone, versus the
standard of care generic version of NARCAN®, intranasal naloxone.
The expectation is that this study will provide the scientific
explanation for the frequent observation that several doses of
NARCAN® are required to reverse a fentanyl overdose or poisoning.
The study results are expected to demonstrate the superiority of
ZIMHI® in terms of speed to recovery from fentanyl-induced
respiratory depression and the cost effectiveness of ZIMHI®”.
- 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. Subsequently, the
company received additional proceeds resulting from exercises after
the closing date of some of the warrants issued in the
transaction.
- On September 8, 2023 the Company changed its name to DMK
Pharmaceuticals Corporation in order to better reflect its new
strategic focus on advancing small molecules for the treatment of
substance use disorders, and began trading under the Nasdaq ticker
symbol “DMK”.
- In October, the Company conducted a series of management
changes to optimize its leadership structure and result in a more
cost-effective, coordinated and streamlined approach to operations.
Seth Cohen was appointed Chief Financial Officer, bringing over
thirty years of financial industry experience to DMK, succeeding
the outgoing interim CFO, President and Chief Operating Officer,
David Marguglio. John Dorbin assumed the role of General Counsel
Corporate Secretary bringing his decades of experience to help the
company manage its legacy legal issues.
- The Company presented preclinical data for DPI-125 in a poster
session at the Society for Neuroscience Annual Meeting (SfN
Neuroscience 2023) held on Monday, November 13, 2023 in Washington
D.C. In a preclinical model of induced opioid dependent rats,
DPI-125 reduced the global number of somatic signs of withdrawal
(SSW) with comparable efficacy to standard of care treatments of
buprenorphine and methadone. Reductions of SSW were statistically
significant across all observation periods, including 0.25mg/kg
DPI-125 (p<0.05), 0.5 and 1.0mg/kg DPI-125 (p’s<0.0001),
2.5mg/kg methadone (p<0.0001) and 0.05mg/kg buprenorphine
(p<0.0001). At the 0.5-1.0 mg/kg dose, DPI-125 demonstrated a
possibly accelerated time course versus 2.5 mg/kg methadone. These
data suggest the potential utility of DPI-125 in improving outcomes
of patients with opioid use disorder and support its further
development for this indication.
Q3 2023 Financial Highlights
- Revenues for the third quarter ending September 30, 2023 were
$0.0 million, compared to $1.5 million for the same period in 2022.
There were no product revenues for SYMJEPI® or ZIMHI® during the
third quarter of 2023 due to continued sourcing issues with the
syringes for SYMJEPI®, and due to the lack of orders for ZIMHI®
from USWM. Revenues for the nine months ending September 30, 2023
and 2022 were approximately $1.5 million and $2.6 million,
respectively. There were no product revenues for SYMJEPI® and there
was a decrease in sales of ZIMHI® during the nine months ended
September 30, 2023 due to continued sourcing issues with the
syringes for SYMJEPI®, and due to a decrease in orders for ZIMHI®
from USWM.
- Selling, general and administrative (SG&A) expenses were
$2.5 million for each of the third quarters of 2023 and 2022.
SG&A expenses for the nine months ending September 30, 2023 and
2022 were $11.3 million and $10.1 million, respectively. The
increase in SG&A expenses was primarily attributable to
increases of approximately $1.4 million of the costs related to the
acquisition of DMK and approximately $0.9 million related to
increased legal expenses, offset by a decrease in compensation and
employment separation expenses of approximately $1.1 million.
- Research and development (R&D) expense for the third
quarter of 2023 was $0.4 million compared to $2.0 million in the
third quarter of 2022. R&D expense for the first nine months of
2023 was $2.1 million, compared to $9.5 million in the same period
in 2022. The decline in both periods was due to the termination of
the clinical development activity related to the Company’s previous
product candidate.
- Net loss for the combined
(continued and discontinued) operations for the third quarter of
2023 was $1.4 million compared to a net loss of $4.4 million in the
third quarter of 2022. The decrease in the net loss was primarily
attributable to a decrease in R&D expenses of approximately
$1.6 million and an increase in other income (expense) of
approximately $1.2 million. Net loss for the nine months ended
September 30, 2023 and 2022 was $18.9 million and $23.2 million,
respectively. The decrease was primarily attributable to a decrease
in R&D expenses of $7.4 million and an increase in gains
recognized upon the revaluation of the warrant liabilities of $2.2
million, offset by a charge during the nine months ended September
30, 2023 of $6.5 million for DMK’s in-process research and
development acquired in the merger.
- Cash and cash equivalents as of
September 30, 2023, were approximately $6.7 million. Additional
cash infusions during third 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 $7.1 million from the Company’s equity financing
transaction that occurred in August 2023.
About DMK Pharmaceuticals
DMK Pharmaceuticals is a commercial stage neuro-biotech company
primarily focused on developing and commercializing products for
the treatment of opioid and substance use disorders. DMK’s
commercial products approved by the FDA are designed to reduce
deaths. ZIMHI® (naloxone) Injection is for the treatment of opioid,
including fentanyl, overdose or poisoning, and SYMJEPI®
(epinephrine) Injection if for use in the emergency treatment of
acute allergic reactions, including anaphylaxis. The Company is
focused on developing novel therapies for opioid use disorder (OUD)
and other important neuro-based conditions where patients are
currently underserved. DMK believes its technologies are at the
forefront of endorphin-inspired drug design with its mono, bi- and
tri-functional small molecules that simultaneously modulate
critical networks in the nervous system. DMK has a library of
approximately 750 small molecule neuropeptide analogues and a
differentiated pipeline that could address unmet medical needs by
taking the novel approach to integrate with the body’s own efforts
to regain balance of disrupted physiology. The Company’s lead
clinical stage product candidate, DPI-125, is being studied as a
potential novel treatment for OUD. DMK 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 DMK
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 anticipated future events or future results of
operations, including, but not limited to, statements concerning
(i) the ability of the Company to raise additional funds required
to sustain the Company’s ongoing operations and fund the
anticipated development activities regarding DPI-125, (ii) whether,
if successfully developed, DPI-125 will receive a more favorable
drug scheduling or be a more patient friendly treatment, (iii) the
potential benefits of DPI-125 if successfully developed, and (iv)
our ability to increase sales of our commercial products. 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. These statements
also assume that the Company will have or be able to obtain
sufficient funding to support the activities described in this
press release, continue the Company’s operations and satisfy the
Company’s liabilities and obligations in a timely manner. There can
be no assurance that this will be the case. Also, such statements
assume that there are no significant unexpected developments or
events that delay or prevent such activities from occurring. The
Company will require additional funds to sustain operations,
satisfy our obligations and liabilities, and fund its ongoing
operations. There are no assurances that required funding will be
available at all or will be available in sufficient
amounts. Failure to timely obtain any required additional
funding, or unexpected developments or events, could delay the
occurrence of such events or prevent the events described in any
such statements from occurring which could adversely affect our
business, financial condition and results of operations. If we
cannot continue as a viable entity, we might be required to reduce
or cease operations or seek dissolution and liquidation or
bankruptcy protection, and our stockholders would likely lose most
or all of their investment in us. 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. 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.
Investor and Media Contact:Maria YonkoskiICR
Westwicke203-682-7167
DMK PHARMACEUTICALS CORPORATION AND
SUBSIDIARIES CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
|
|
September 30,2023 |
|
|
December 31,2022 |
|
Cash and Cash Equivalents |
|
$ |
6,663,921 |
|
|
|
$ |
1,081,364 |
|
|
Total Current Assets |
|
|
7,872,061 |
|
|
|
|
9,272,150 |
|
|
Total Assets |
|
|
8,957,411 |
|
|
|
|
10,930,840 |
|
|
Total Liabilities |
|
|
13,922,050 |
|
|
|
|
11,581,605 |
|
|
Accumulated Deficit |
|
|
(323,469,161 |
) |
|
|
|
(304,564,086 |
) |
|
Total Stockholders’ Deficit |
|
|
(5,294,639 |
) |
|
|
|
(808,068 |
) |
|
DMK PHARMACEUTICALS CORPORATION AND
SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS
DATA (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
|
Revenue, net |
|
$ |
9,062 |
|
|
|
$ |
1,505,683 |
|
|
|
$ |
1,469,007 |
|
|
|
$ |
2,605,396 |
|
|
Costs of goods sold |
|
|
338,488 |
|
|
|
|
1,647,585 |
|
|
|
|
2,487,948 |
|
|
|
|
3,705,697 |
|
|
Selling, General and
Administrative |
|
|
2,517,161 |
|
|
|
|
2,508,176 |
|
|
|
|
11,332,333 |
|
|
|
|
10,096,807 |
|
|
Research and Development |
|
|
418,518 |
|
|
|
|
1,977,939 |
|
|
|
|
2,106,004 |
|
|
|
|
9,520,118 |
|
|
Acquired In-Process Research
and Development |
|
|
— |
|
|
|
|
— |
|
|
|
|
6,539,675 |
|
|
|
|
— |
|
|
Loss from Operations |
|
|
(3,265,105 |
) |
|
|
|
(4,628,017 |
) |
|
|
|
(20,996,953 |
) |
|
|
|
(20,717,226 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Other Income (Expense),
net |
|
|
1,528,857 |
|
|
|
|
356,808 |
|
|
|
|
3,242,705 |
|
|
|
|
(2,079,191 |
) |
|
Net Loss from Continuing
Operations, before taxes |
|
|
(1,736,248 |
) |
|
|
|
(4,271,209 |
) |
|
|
|
(17,754,248 |
) |
|
|
|
(22,796,417 |
) |
|
Net Income (Loss) from
Discontinued Operations |
|
|
348,202 |
|
|
|
|
(127,692 |
) |
|
|
|
(1,150,827 |
) |
|
|
|
(354,320 |
) |
|
Net Loss Applicable to Common
Stock |
|
$ |
(1,388,046 |
) |
|
|
$ |
(4,398,901 |
) |
|
|
$ |
(18,905,075 |
) |
|
|
$ |
(23,150,737 |
) |
|
Basic and Diluted Loss Per
share |
|
$ |
(0.20 |
) |
|
|
$ |
(2.05 |
) |
|
|
$ |
(4.82 |
) |
|
|
$ |
(10.82 |
) |
|
Basic and Diluted Weighted
Average Shares Outstanding |
|
|
7,065,673 |
|
|
|
|
2,142,618 |
|
|
|
|
3,957,733 |
|
|
|
|
2,140,097 |
|
|
DMK Pharmaceuticals (NASDAQ:DMK)
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DMK Pharmaceuticals (NASDAQ:DMK)
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