DMK Pharmaceuticals Announces Presentation of Preclinical Results Comparing Effects of DPI-125 on Opioid Withdrawal Behaviors Versus Standard of Care for Opioid Use Disorder at SfN Neuroscience 2023

SAN DIEGO, Nov. 13, 2023 (GLOBE NEWSWIRE) — DMK Pharmaceuticals Corporation (NASDAQ: DMK), a commercial stage neuro-biotech company primarily focused on developing and commercializing products for the treatment of opioid overdose and substance use disorders, today announced the presentation of preclinical results comparing the effects of DPI-125 on opioid withdrawal behaviors to methadone and buprenorphine, the standard of care for opioid use disorder (OUD), in a poster session at the Society for Neuroscience Annual Meeting (SfN Neuroscience 2023) held November 11-13, 2023 in Washington D.C. DPI-125 is a novel, small-molecule triple (mu, delta and kappa) opioid receptor agonist, being developed for the treatment of opioid use disorder.

“Only about 12% of patients receive treatment for OUD, despite the proven efficacy of current medications. Buprenorphine, the market leader with US sales in excess of $3B in 2022, requires an induction phase to induce withdrawal symptoms prior to initiating the first dose. It is challenging for a patient to voluntarily experience these symptoms. In addition, buprenorphine can be abused. For this and other reasons, widespread adoption is low. We believe that DPI-125, our novel clinical stage compound, will be able to overcome this and several other barriers to treatment initiation and maintenance. The positive data to be presented today marks the first step to realizing this promise,” said Eboo Versi, M.D., Ph.D., CEO of DMK Pharmaceuticals. “We are excited to present preclinical data comparing DPI-125, a triple opioid agonist, to the standard of care treatments buprenorphine and methadone to alleviate withdrawal symptoms. This preclinical study was financially supported by a grant from the National Institute of Drug Abuse (NIDA), and we believe that it warrants further development.”

Details of the poster are as follows:

Title: Effect of DPI-125 on opioid withdrawal behaviors in rats: a comparison study with
methadone and buprenorphine
Program Number / Poster Number: Poster 297.01 / SS14
Session Title: G.09. Drugs of Abuse and Addiction
Session Date, Time: Monday, November 13, 2023, 1:00 p.m. – 5:00 p.m. ET
Presenter: Adam Mar, Ph.D., Assistant Professor, Department of Neuroscience and Physiology at NYU Grossman School of Medicine
Location: WCC Halls A-C

The poster will be available on DMK’s website following the presentation session.

For more details about the Society for Neuroscience Annual Meeting, please visit: https://www.sfn.org/meetings/neuroscience-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 overdose and substance use disorders. DMK’s 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. 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.

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