- This would be Dermata's second patent for DMT410, if issued, using its Spongilla technology to topically deliver botulinum toxin for hyperhidrosis -

- The Company recently entered into a Clinical Trial Collaboration Agreement with Revance to study DMT410 for the treatment of axillary hyperhidrosis -

- The Company also has an issued patent in Japan covering their DMT410 program for the treatment of hyperhidrosis -

SAN DIEGO, CA / ACCESS Newswire / February 25, 2025 / Dermata Therapeutics, Inc. (NASDAQ: DRMA)(NASDAQ: DRMAW) ("Dermata" or the "Company"), a late-stage biotechnology company focusing on the treatment of medical and aesthetic skin diseases and conditions, today announced the Australian Patent Office has accepted its patent application for its DMT410 program for the treatment of hyperhidrosis. The patent, entitled "Compositions for the treatment of skin conditions," (Australian Patent Application No. 2109284621) continues to strengthen Dermata's global intellectual property portfolio for DMT410 for the treatment of hyperhidrosis. The patent will be automatically issued three months after acceptance unless a third party files an opposition.

"We are thrilled to receive this acceptance as we believe it further validates DMT410's innovative approach to delivering botulinum toxin topically for the treatment of hyperhidrosis," said Gerry Proehl, Dermata's Chairman, President, and CEO. "We see significant opportunities for our DMT410 program, and we are eager to move forward with our planned Phase 2a study in collaboration with Revance Therapeutics, who also has DAXXIFY® approved in Australia. This Phase 2a study will explore DMT410, which combines a single application of XYNGARI™ followed by a topical application of DAXXIFY® for the treatment of axillary hyperhidrosis. Beyond hyperhidrosis, we believe DMT410 holds promise as a versatile treatment for a range of skin conditions, including acne, rosacea, melasma, acne scars, and other aesthetic concerns that are in need of more effective solutions," Mr. Proehl added.

About DMT410

DMT410 is the Company's combination treatment regimen that uses the unique mechanical features of the Company's XYNGARI™ product candidate to facilitate the intradermal delivery of botulinum toxin by topical application rather than through multiple injections with a needle. The treatment consists of an initial topical application of XYNGARI™ to the treatment area where the microscopic spicules penetrate the stratum corneum to create microchannels into the dermis allowing for the topical application and penetration of botulinum toxin. The Company has successfully completed proof-of-concept Phase 1 clinical trials using DMT410 in combination with BOTOX® for the treatment of primary axillary hyperhidrosis and for the treatment of multiple aesthetic skin conditions. Both studies showed promising efficacy results and appeared to be safe and well tolerated by patients. The Company is also planning to initiate a Phase 2a study of DMT410 (XYNGARI™ with DAXXIFY®) for the treatment of axillary hyperhidrosis.

About Dermata Therapeutics

Dermata Therapeutics is a late-stage biotechnology company focusing on the treatment of medical and aesthetic skin diseases and conditions. Dermata's lead product candidate, XYNGARI™ (formerly DMT310), is its first product candidate being developed from its Spongilla technology platform. XYNGARI™ is a once-weekly, topical product candidate derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action. In addition to acne, XYNGARI™ has been studied for the treatment of psoriasis and rosacea. Dermata's second program, uses XYNGARI™ as a new method for needle-free intradermal delivery of botulinum toxin for the treatment of multiple aesthetic and medical skin diseases and conditions. Dermata is headquartered in San Diego, California. For more information, please visit http://www.dermatarx.com/.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company's current beliefs and expectations and new risks may emerge from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions, and other factors including, but are not limited to, statements related to: expectations with regard to the timing of meetings and/or responses from submissions with regulatory bodies, including the FDA; the uncertainties inherent in clinical trials; expectations with regard to any potential partnership opportunities for any of the Company's product candidates; the Company's expectations with regard to current cash and cash equivalents and the amount of time it will fund operations; the success, cost, and timing of its product candidate DMT410 development activities and ongoing and planned clinical trials; whether the results of any planned clinical trials of DMT410 will lead to future product development; whether pending patent applications will proceed to allowance without interruption, if at all; and whether pending, accepted, or issued patents will provide adequate protection for the Company's product candidates, if approved. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval, and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Dermata's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

Investors:
Cliff Mastricola
Investor Relations
cmastricola@dermatarx.com

SOURCE: Dermata Therapeutics