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Anticipated Upcoming Milestones

• Announce topline results in its XYNGARI™ Phase 3 STAR-1 clinical trial in moderate-to-severe acne. Dermata plans to announce topline results from the XYNGARI™ Phase 3 STAR-1 trial by the end of March 2025.

• Initiate the second XYNGARI™ Phase 3 STAR-2 clinical trial in moderate-to-severe acne. Assuming positive results from the STAR-1 trial, the Company plans to quickly move to initiate the second of two Phase 3 trials of XYNGARI™ for the treatment of moderate-to-severe acne, which will be followed by an extension study.

• Continue preparation of DMT410 Phase 2a clinical study with Revance. The Company and Revance continue to collaborate on the final study design and start-up procedures to prepare for the Phase 2a clinical study of XYNGARI™ with DAXXIFY® for the topical treatment of axillary hyperhidrosis.

Full Year 2024 Financial Results
As of December 31, 2024, the Company had $3.2 million in cash and cash equivalents, compared to $7.4 million as of December 31, 2023. The $4.2 million decrease in cash and cash equivalents for the year ended December 31, 2024, resulted from approximately $11.1 million of cash used in operations offset by approximately $6.9 million in net financing proceeds. Including the $2.55 million in gross proceeds from the January 2025 PIPE financing, the Company expects its current cash resources to be sufficient to fund operations into the third quarter of 2025.

Research and development expenses were $8.2 million for the year ended December 31, 2024, compared to $4.1 million for the year ended December 31, 2023. The $4.1 million increase in research and development expense for the year ended December 31, 2024, was the result of $4.9 million of increased clinical trial expenses related to running the XYNGARI™ Phase 3 STAR-1 clinical trial, offset by approximately $0.2 million in decreased non-clinical expenses and approximately $0.6 million in decreased chemistry, manufacturing, and controls, or CMC, expenses.

General and administrative expenses were $4.3 million for the year ended December 31, 2024, compared to $4.0 million for the year ended December 31, 2023. The increase in general and administrative expenses was primarily attributable to $0.3 million in increased audit related fees as a result of changing auditors in late 2023.

About Dermata Therapeutics
Dermata Therapeutics is a late-stage biotechnology company focusing on the treatment of medical skin diseases and aesthetic applications. The Company's lead product candidate, XYNGARI™, is the 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. The Company's second product candidate, DMT410, uses its XYNGARI™ product candidate as a new method for needle-free intradermal delivery of botulinum toxin for the treatment of multiple medical skin diseases and applications. 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; expectations with regard to the timing of submission of an NDA; the uncertainties inherent in clinical trials including enrolling an adequate number of patients on time or to be completed on schedule, if at all; timing and ability to generate clinical data; expectations with regard to the nature of any clinical data; 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 candidates XYNGARI™ and DMT410 development activities and ongoing and planned clinical trials; and whether the results of any ongoing or planned clinical trials of XYNGARI™ or DMT410 will lead to future product development. 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.

DERMATA THERAPEUTICS, INC.
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DERMATA THERAPEUTICS, INC.
Statements of Operations

Investors:
Cliff Mastricola
Investor Relations
cmastricola@dermatarx.com

SOURCE: Dermata Therapeutics

View the original press release on ACCESS Newswire