SAN DIEGO - Dermata Therapeutics, Inc. (Nasdaq:DRMA), a clinical-stage biotech company with a market capitalization of $4.4 million, announced today that its topical acne treatment candidate, XYNGARI™, demonstrated statistically significant efficacy against placebo after just four once-weekly applications. According to InvestingPro data, while the company maintains a healthy cash position relative to debt, its overall financial health score remains challenged at 1.31 out of 5. This finding is based on additional analysis of topline data from the company’s Phase 3 STAR-1 trial, focusing on moderate-to-severe acne.
The STAR-1 study, which enrolled 520 patients across the United States and Latin America, revealed that 11.9% of participants treated with XYNGARI™ achieved a 2-point reduction and a score of "clear" or "almost clear" on the Investigator Global Assessment (IGA) at week 4. These results come as the company’s stock has experienced significant pressure, down 40% year-to-date and 82% over the past year, as tracked by InvestingPro. This was compared to 6.2% of patients in the placebo group. The treatment also showed a greater mean reduction in both inflammatory and non-inflammatory lesion counts, with p-values of less than 0.001, indicating a high level of statistical significance.
Dr. Christopher Nardo, Chief Development Officer at Dermata, expressed optimism about the early separation from placebo, suggesting that the quick response could improve patient compliance. The company believes that the once-weekly application of XYNGARI™ could become a differentiator in the market.
The STAR-1 trial is part of a larger Phase 3 program that, if successful, could lead to the submission of a new drug application to the U.S. Food and Drug Administration. Despite current market challenges, analysts maintain a $6 price target for the stock, though InvestingPro subscribers can access additional insights, including more than 10 key financial tips and detailed valuation metrics.
XYNGARI™, originally known as DMT310, is derived from a freshwater sponge and has multiple mechanisms of action. These include mechanical components that may help exfoliate the skin and promote collagen production, as well as chemical compounds that exhibit antimicrobial and anti-inflammatory properties.
Dermata Therapeutics specializes in developing treatments for medical skin diseases and aesthetic applications. In addition to acne, XYNGARI™ is also being studied for the treatment of psoriasis and rosacea. The company is headquartered in San Diego, California.
This announcement is based on a press release statement and contains forward-looking statements regarding the potential market acceptance of Dermata’s product candidates and the timing of future clinical trials and regulatory submissions. These statements are subject to risks and uncertainties, and actual results may differ from those projected. Current financial metrics indicate the company is not yet profitable, with analysts not anticipating profitability this year, according to InvestingPro analysis.
In other recent news, Dermata Therapeutics, Inc. announced successful Phase 3 trial results for their acne treatment, XYNGARI™, which met all primary endpoints. The trial involved 520 patients and demonstrated significant improvements in both inflammatory and non-inflammatory acne lesions. These positive results have set the stage for a subsequent Phase 3 trial, STAR-2, planned for the latter half of 2025. In addition, Dermata has secured $2.55 million in a private placement transaction involving the sale of over 2 million shares and warrants, with H.C. Wainwright & Co. serving as the exclusive placement agent. The proceeds are earmarked for general corporate purposes, including research and clinical trials. However, the company also faces a delisting warning from The Nasdaq Capital Market due to non-compliance with the minimum stockholders’ equity requirement. Dermata has until May 2025 to submit a compliance plan to Nasdaq. The company’s future on the Nasdaq remains uncertain as it works to address this equity deficiency.
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