Rebranded company to DMK Pharmaceuticals and appointed inaugural, passionate and committed leadership team to execute on new strategy to reduce opioid related deaths through enhanced sales of ZIMHI® and thus increase shareholder value
Developed holistic company growth strategy to create a cost effective, coordinated, streamlined approach to operations to increase value for patients and shareholders
Presented preclinical data for DPI-125 at the Society of Neuroscience Annual Meeting 2023 on November 13, 2023; results supported further development of DPI-125 as a potential treatment of opioid use disorder
SAN DIEGO, Nov. 14, 2023 (GLOBE NEWSWIRE) — 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
Q3 2023 Financial Highlights
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 Yonkoski
ICR Westwicke
203-682-7167
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 SUBSIDIARIES
CONSOLIDATED 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 |
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