Latest news with #DermataTherapeutics
Yahoo
28-03-2025
- Business
- Yahoo
Dermata Therapeutics Announces Exercise of Warrants for $6.2 Million in Gross Proceeds Priced At-the-Market Under Nasdaq Rules
SAN DIEGO, CA / / March 27, 2025 / Dermata Therapeutics, Inc. (NASDAQ:DRMA)(NASDAQ:DRMAW) ("Dermata," or the "Company"), a late-stage biotechnology company focused on the treatment of medical skin diseases and aesthetic applications, today announced the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase an aggregate of 4,834,470 shares of the Company's common stock, having exercise prices of $1.58 and $4.91 per share, issued by Dermata in September 2024 (with respect to 3,825,138 warrants) and May 2024 (with respect to 1,009,332 warrants), at a reduced exercise price of $1.284 per share. The shares of common stock issuable upon exercise of the warrants are registered pursuant to effective registration statements on Form S-3 (File Nos. 333-282223 and 333-280682). The closing of the offering is expected to occur on or about March 28, 2025, subject to satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive financial advisor to Dermata in connection with the offering. In consideration for the immediate exercise of the warrants for cash, Dermata will issue new unregistered Series A warrants to purchase up to 4,980,806 shares of common stock and new Series B warrants to purchase up to 4,688,134 shares of common stock. The new warrants will have an exercise price of $1.284 per share, will be exercisable upon approval by the Company's shareholders and have a term equal to five years from the date of shareholder approval with respect to Series A warrants, and have a term equal to 18 months from the date of shareholder approval with respect to Series B warrants. The gross proceeds to Dermata from the exercise of the warrants are expected to be approximately $6.2 million, prior to deducting fees and offering expenses. The Company intends to use the net proceeds for general corporate purposes, which includes, without limitation, ongoing research and pre-clinical studies, clinical trials, the development of new biological and pharmaceutical technologies, investing in or acquiring companies that are synergistic with or complementary to the Company's technologies, licensing activities related to the Company's current and future product candidates, and to the development of emerging technologies, investing in or acquiring companies that are developing emerging technologies, licensing activities, or the acquisition of other businesses and working capital. The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act"), and, along with the shares of common stock issuable upon exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. Dermata has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. 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 currently in Phase 3 and is the Company's 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™ is being 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 aesthetic applications and medical skin diseases. Dermata is headquartered in San Diego, California. For more information, please visit 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: the timing and completion of the offering; the satisfaction of customary closing conditions related to the offering and the intended use of proceeds therefrom; the receipt of shareholder approval; 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 be completed on schedule, if at all; timing and ability to generate 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, including, but not limited to, market and other conditions. 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: Sean ProehlAssociate General Counselinfo@ SOURCE: Dermata Therapeutics View the original press release on ACCESS Newswire Sign in to access your portfolio
Associated Press
27-03-2025
- Business
- Associated Press
BREAKING: Dermata's XYNGARI™ Phase 3 Trial Topline Data Meets All Primary Endpoints
- XYNGARI™ achieved its primary endpoints, demonstrating highly statistically significant and clinically meaningful improvement in acne - - XYNGARI™ is the first once-weekly topical product candidate to demonstrate clinical benefit in a Phase 3 clinical trial for moderate-to-severe acne - - Over 30 million acne patients seek treatment in the U.S. each year - SAN DIEGO, March 26, 2025 /PRNewswire/ -- Dermata Therapeutics, Inc. (Nasdaq: DRMA, DRMAW) ('Dermata' or the 'Company'), a late-stage biotechnology company focusing on the treatment of medical skin diseases and aesthetic applications, today announced positive topline results from the Company's first pivotal Phase 3 trial of XYNGARI™, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne. XYNGARITM also appeared to be safe and well tolerated by patients with minimal treatment related adverse events and no serious adverse events attributed to treatment. The XYNGARI™ Phase 3 Spongilla Treatment for Acne Research (STAR-1) trial met all three primary endpoints by achieving a statistically significant difference when compared with placebo after 12 weeks of once weekly treatments with XYNGARI™. 'I believe having a once-weekly topical product with a strong efficacy and safety profile, like XYNGARI™, would be a great addition to a dermatologist's arsenal for treating acne,' commented Dr. Sunil Dhawan, MD, FAAD, FACP, clinical investigator at the Center for Dermatology Clinical Research, Inc., a participating site in the STAR-1 trial. 'All FDA approved topical acne products are required to be applied at least once or twice a day, which may reduce patient compliance, so I believe having a once-weekly topical acne product like XYNGARI™ could lead to improved patient compliance,' concluded Dr. Dhawan. 'We are incredibly excited about these Phase 3 clinical trial results for XYNGARI™, which we believe reinforce its potential as a unique acne treatment, distinct from any existing product on the market,' said Gerry Proehl, Chairman, President, and Chief Executive Officer of Dermata. 'The highly statistically significant efficacy data not only confirms the results of our Phase 2b acne study but also strengthens our confidence about the upcoming XYNGARI™ Phase 3 STAR-2 trial, set to launch in the second half of 2025. With these positive Phase 3 clinical trial results, we are eager to advance discussions with potential partners interested in securing future rights to XYNGARI™,' Mr. Proehl added. XYNGARI™ Phase 3 STAR-1 Clinical Study Design The XYNGARI™ Phase 3 STAR-1 clinical study evaluated the efficacy, safety, and tolerability of XYNGARI™ in patients with moderate-to-severe facial acne. The STAR-1 study was a randomized (2:1), double-blind, and placebo-controlled study which enrolled 520 patients with moderate-to-severe acne, ages 9 years and older in the United States and Latin America. The primary endpoints include the mean change from baseline in inflammatory and noninflammatory lesion counts and the Investigator Global Assessment (IGA) treatment response. IGA is measured on a 5-point scale (0-4), with a treatment response defined as at least a 2-point improvement from baseline and an IGA score of 0 (clear) or 1 (almost clear). Patients were treated once-a-week for 12 weeks with either XYNGARI™ or placebo and were evaluated monthly. The STAR-1 study is the first of two pivotal Phase 3 studies, with the second Phase 3 study to be followed by an extension study. If positive, the results of the Phase 3 program would be used to support the filing of a new drug application with the U.S. Food and Drug Administration. XYNGARI™ Phase 3 STAR-1 Topline Efficacy Results In the intent to treat analysis, Dermata saw statistically significant differences in IGA treatment success, inflammatory lesion count, and non-inflammatory lesion count at Week 12 (study end) when compared to placebo. Investigator Global Assessment: Patients achieving a 2-point reduction AND score of 0 or 1 ('clear' or 'almost clear') Week 12 XYNGARI™ (n=342) Placebo (n=178) p-value p < 0.001 Mean change from baseline in inflammatory lesion count Week 12 XYNGARI™ (n=342) Placebo (n=178) p-value p < 0.001 Mean change from baseline in non-inflammatory lesion count Week 12 XYNGARI™ (n=342) Placebo (n=178) p-value p < 0.001 'We wish to thank the study subjects and investigators for their participation in our study, as we could not have had this success without them,' states Christopher Nardo, Ph.D., Chief Development Officer of Dermata. 'The clinical response observed in our XYNGARI™ Phase 3 STAR-1 trial gives us confidence that XYNGARI™, if approved, could alter the current treatment paradigm in acne by providing patients with a novel, natural, once-weekly treatment option with minimal side effects and potentially quicker time to treatment effect.' Based on these results, Dermata plans to initiate the second XYNAGRI™ Phase 3 STAR-2 trial in the second half of 2025, which will be followed by an open-label extension study. If the STAR-2 study produces positive results, the Phase 3 program will help support the filing of a new drug application with the U.S. Food and Drug Administration. About XYNGARI™ (formerly DMT310) XYNGARI™ is a novel, once-weekly, topical product candidate derived from a freshwater sponge being developed for the treatment of multiple skin diseases. XYNGARI™ has multiple mechanisms of action that include mechanical components and chemical compounds to help treat inflammatory skin diseases, like acne. After processing, the sponge powder contains precisely sized and shaped silica spicules that upon application may help exfoliate the skin, promote collagen production, open closed comedones (creating an aerobic environment to help kill C. acne bacteria), and create microchannels to facilitate penetration of the sponge's naturally occurring chemical compounds. These chemical compounds have been shown, in-vitro, to have both antimicrobial and anti-inflammatory properties, which may play a significant role in the treatment of inflammatory skin diseases. About Acne Vulgaris Over 30 million acne patients in the U.S. seek treatment each year, with about 85% of U.S. teenagers experiencing some form of acne, and some individuals suffering from acne well into their 30s, 40s, and beyond. Acne is characterized by areas of scaly red skin, non-inflammatory blackheads and whiteheads, inflammatory papules and pustules, and occasionally cysts and scarring, which can present on the face, neck, chest, back, shoulders, and upper arms. While not life-threatening, acne can cause significant trauma for those suffering from it due to social stigmas, substantial risk of permanent facial scarring, lowered self-esteem, and social withdrawal. 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 currently in Phase 3 and is the Company's 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™ is being 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 aesthetic applications and medical skin diseases. Dermata is headquartered in San Diego, California. For more information, please visit . 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 potential market acceptance of any of the Company's product candidates; timing of trials and data events, including the initiation of a Phase 3 STAR-2 trial and extension study; expectations with regard to the timing and/or results or responses from meetings with regulatory bodies, including the FDA; expectations with regard to the timing of a New Drug Application with the FDA; the success, cost, funds available, and timing of its product candidate XYNGARI™ development activities and ongoing and planned clinical trials; and whether the results of XYNGARI™ will lead to future product development, partnerships, or approvals. These forward-looking statements are generally identified by the use of such words as 'may,' 'could,' 'should,' 'would,' 'believe,' 'anticipate,' 'forecast,' 'estimate,' 'expect,' 'intend,' 'plan,' 'continue,' 'outlook,' 'will,' 'potential' and similar statements of a future or forward-looking nature. 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, 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 [email protected] View original content to download multimedia: SOURCE Dermata Therapeutics, Inc.
Associated Press
28-01-2025
- Business
- Associated Press
Dermata Expands Patent Portfolio with Issuance of New U.S. Patent for Next-Generation Acne Treatment
- This is Dermata's first issued U.S. patent for XYNGARI™, which uses its Spongilla technology to topically treat acne - - Dermata expects to announce topline results from its STAR-1 Phase 3 XYNGARI™ clinical trial in March 2025 - - Over 30 million acne patients seek treatment in the U.S. each year, with topical products being first-line therapy - SAN DIEGO, CA / ACCESS Newswire / January 28, 2025 / Dermata Therapeutics, Inc. (Nasdaq:DRMA, DRMAW) ('Dermata' or the 'Company'), a late-stage biotechnology company focusing on the treatment of medical and aesthetic skin diseases and conditions, today announced issuance by the United States Patent and Trademark Office of a new patent for its XYNGARI™ product candidate for the treatment of acne. The issued patent, entitled 'Compositions and methods for the treatment of skin conditions' (U.S. Patent No. 12,208,123), further strengthens Dermata's intellectual property protections for XYNGARI™. 'The issuance of this U.S. patent showcases the unique nature of our XYNGARI product candidate as a novel treatment for acne, if approved,' commented Gerry Proehl, Dermata's Chairman, President, and CEO. 'We believe XYNGARI's once weekly treatment regimen, good tolerability, and demonstrated rapid efficacy, will lead to enhanced patient compliance, thereby improving patient outcomes. Now we are eagerly awaiting the STAR-1 clinical results from our first of two Phase 3 clinical trials of XYNGARI, which, if positive, we plan to begin the second Phase 3 acne trial later this year.' About XYNGARI™ XYNGARI™(formerly DMT310) is a novel, once-weekly, topical product candidate derived from a freshwater sponge being developed for the treatment of multiple skin diseases. XYNGARI™ has multiple mechanisms of action that includemechanical components and chemical compounds to help treat inflammatory skin diseases, like acne. After processing, the sponge powder contains precisely sized and shaped silica spicules that upon application may help exfoliate the skin, promote collagen production, open closed comedones (creating an aerobic environment to help kill C. acne bacteria), and create microchannels to facilitate penetration of the sponge's naturally occurring chemical compounds. These chemical compounds have been shown, in-vitro, to have both antimicrobial and anti-inflammatory properties, which may play a significant role in the treatment of inflammatory skin diseases. XYNGARI™ has previously shown its treatment effect in moderate-to-severe acne in a Phase 2b study where XYNGARI™, applied once weekly, achieved statistically significant results at all timepoints for all primary and secondary endpoints. XYNGARI™ also observed almost 45% of patients achieving an IGA score of clear or almost clear compared with less than 18% of placebo patients achieving the same at the end of 12 weeks. About Acne Vulgaris Over 30 million acne patients in the U.S. seek treatment each year, with about 85% of teenagers experiencing some form of acne, and some individuals suffering from acne well into their 30s, 40s, and beyond. Acne is characterized by areas of scaly red skin, noninflammatory blackheads and whiteheads, inflammatory papules and pustules, and occasionally cysts and scarring, which can present on the face, neck, chest, back, shoulders, and upper arms. While not life-threatening, acne can cause significant trauma for those suffering from it due to social stigmas, substantial risk of permanent facial scarring, lowered self-esteem, and social withdrawal. 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 . 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 potential market acceptance of any of the Company's product candidates; timing of trials and data events; expectations with regard to the timing and/or results or responses from meetings with regulatory bodies, including the FDA; the success, cost, funds available, and timing of its product candidate XYNGARI™ development activities and ongoing and planned clinical trials; whether the results of XYNGARI™ will lead to future product development or approvals; whether pending patent applications will proceed to allowance without interruption, if at all, and whether pending or issued patents will provide adequate protection for the Company's product candidates, if approved. These forward-looking statements are generally identified by the use of such words as 'may,' 'could,' 'should,' 'would,' 'believe,' 'anticipate,' 'forecast,' 'estimate,' 'expect,' 'intend,' 'plan,' 'continue,' 'outlook,' 'will,' 'potential' and similar statements of a future or forward-looking nature. 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, 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 [email protected] SOURCE: Dermata Therapeutics press release
