Dermata Therapeutics Provides Corporate Update and Reports Second Quarter 2025 Financial Results
Dermata Therapeutics (NASDAQ:DRMA) reported significant progress in Q2 2025, highlighted by positive Phase 3 STAR-1 trial results for XYNGARI™ in treating moderate-to-severe acne. The trial achieved statistically significant results for all three co-primary endpoints at both 4 and 12 weeks versus placebo.
The company strengthened its financial position by raising $8.8 million in gross proceeds through private placement and warrant inducement financings in H1 2025. As of June 30, 2025, Dermata had $6.5 million in cash, expected to fund operations into Q2 2026. Q2 R&D expenses decreased to $0.6 million from $2.0 million year-over-year, while G&A expenses increased to $1.2 million from $0.9 million.
Dermata Therapeutics (NASDAQ:DRMA) ha riportato progressi significativi nel secondo trimestre 2025, con i risultati positivi della fase 3 STAR-1 per XYNGARI™ nel trattamento dell'acne da moderata a grave. Lo studio ha raggiunto risultati statisticamente significativi per tutti e tre gli endpoint co-primari sia a 4 che a 12 settimane rispetto al placebo.
L'azienda ha rafforzato la posizione finanziaria raccogliendo 8,8 milioni di dollari di proventi lordi tramite collocamento privato e finanziamenti legati ai warrant nella prima metà del 2025. Al 30 giugno 2025 Dermata disponeva di 6,5 milioni di dollari in cassa, importo che dovrebbe finanziare le operazioni fino al secondo trimestre 2026. Le spese di R&S nel secondo trimestre sono scese a 0,6 milioni da 2,0 milioni su base annua, mentre le spese G&A sono aumentate a 1,2 milioni da 0,9 milioni.
Dermata Therapeutics (NASDAQ:DRMA) informó avances significativos en el segundo trimestre de 2025, destacando los resultados positivos del ensayo de fase 3 STAR-1 de XYNGARI™ en el tratamiento del acné moderado a severo. El ensayo alcanzó resultados estadísticamente significativos en los tres endpoints co-primarios tanto a las 4 como a las 12 semanas frente a placebo.
La compañía reforzó su posición financiera al recaudar $8.8 millones en ingresos brutos mediante colocación privada y financiamientos por incentivos de warrants en el primer semestre de 2025. Al 30 de junio de 2025, Dermata contaba con $6.5 millones en efectivo, que se espera financien las operaciones hasta el segundo trimestre de 2026. Los gastos de I+D del segundo trimestre bajaron a $0.6 millones desde $2.0 millones interanualmente, mientras que los gastos G&A aumentaron a $1.2 millones desde $0.9 millones.
Dermata Therapeutics (NASDAQ:DRMA)는 2025년 2분기에 중요한 진전을 보고했습니다. 특히 중등도~중증 여드름 치료를 위한 XYNGARI™의 임상 3상 STAR-1 시험에서 긍정적인 결과를 얻었습니다. 이 시험은 4주 및 12주 시점에서 위약 대비 세 가지 공동 주요 평가변수 모두에 대해 통계적으로 유의한 결과를 달성했습니다.
회사는 2025년 상반기에 사모 발행 및 워런트 인센티브 금융을 통해 $8.8 million의 총 조달금액으로 재무 기반을 강화했습니다. 2025년 6월 30일 현재 Dermata는 $6.5 million의 현금을 보유하고 있어 2026년 2분기까지 운영 자금을 확보할 것으로 예상됩니다. 2분기 연구개발비는 전년 동기 2.0 million에서 $0.6 million로 감소한 반면, 일반관리비는 $1.2 million으로 0.9 million에서 증가했습니다.
Dermata Therapeutics (NASDAQ:DRMA) a annoncé des progrès significatifs au T2 2025, notamment des résultats positifs de l'essai de phase 3 STAR‑1 pour XYNGARI™ dans le traitement de l'acné modérée à sévère. L'étude a atteint des résultats statistiquement significatifs pour les trois critères co‑primaires à 4 et 12 semaines par rapport au placebo.
La société a renforcé sa situation financière en levant 8,8 millions de dollars de produits bruts via un placement privé et des financements incitatifs de bons de souscription au premier semestre 2025. Au 30 juin 2025, Dermata disposait de 6,5 millions de dollars en trésorerie, montant censé financer les opérations jusqu'au T2 2026. Les dépenses R&D du deuxième trimestre ont diminué à 0,6 million contre 2,0 millions en glissement annuel, tandis que les frais G&A ont augmenté à 1,2 million contre 0,9 million.
Dermata Therapeutics (NASDAQ:DRMA) meldete im zweiten Quartal 2025 bedeutende Fortschritte, insbesondere positive Phase‑3‑Ergebnisse der STAR‑1‑Studie für XYNGARI™ zur Behandlung von mittelschwerer bis schwerer Akne. Die Studie erzielte statistisch signifikante Ergebnisse für alle drei gemeinsamen primären Endpunkte sowohl nach 4 als auch nach 12 Wochen gegenüber Placebo.
Das Unternehmen stärkte seine Finanzlage durch die Beschaffung von 8,8 Mio. USD an Bruttoerlösen mittels Privatplatzierung und Warrant‑Incentive‑Finanzierungen in der ersten Hälfte 2025. Zum 30. Juni 2025 verfügte Dermata über 6,5 Mio. USD an Barbestand, die voraussichtlich die Geschäftstätigkeit bis Q2 2026 finanzieren. Die F&E‑Aufwendungen im Q2 sanken auf 0,6 Mio. gegenüber 2,0 Mio. im Jahresvergleich, während die G&A‑Kosten auf 1,2 Mio. von 0,9 Mio. anstiegen.
- Phase 3 STAR-1 trial met all three primary endpoints with statistically significant results
- Early efficacy demonstrated with significant results at week 4
- Raised $8.8 million in gross proceeds during H1 2025
- Cash runway extended into Q2 2026
- R&D expenses decreased by $1.4 million year-over-year
- Second Phase 3 STAR-2 trial still needed before FDA application
- G&A expenses increased by $0.3 million year-over-year
- Additional manufacturing and clinical trials will require significant capital
Insights
Dermata's XYNGARI shows strong Phase 3 results for acne with improved cash position, but faces regulatory hurdles ahead.
Dermata's Q2 update highlights a critical milestone with their lead asset XYNGARI meeting all three co-primary endpoints in the Phase 3 STAR-1 trial for moderate-to-severe acne. The statistically significant separation from placebo at both week 12 (FDA-required endpoint) and as early as week 4 demonstrates potentially competitive efficacy in the crowded acne market.
On the financial front, Dermata has meaningfully strengthened its position, raising
R&D expenses decreased significantly to
The collaboration with Revance on DMT410 for hyperhidrosis represents a secondary value driver, though specific timelines remain undefined. The regulatory pathway appears straightforward but lengthy, with multiple additional studies required before commercialization can be considered. This positions Dermata as a clinical-stage biotech with promising data but still facing significant development hurdles before reaching revenue generation.
- Dermata announced additional positive data from its XYNGARI™ Phase 3 Spongilla Treatment of Acne Research (STAR-1) clinical trial-
- Raised
SAN DIEGO, CALIFORNIA / ACCESS Newswire / August 13, 2025 / Dermata Therapeutics, Inc. (Nasdaq:DRMA; DRMAW) ("Dermata," or the "Company"), a late-stage biotechnology company focused on the treatment of medical skin diseases and aesthetic applications, today highlighted recent corporate progress and reported financial results for the second quarter ended June 30, 2025.
"We are very excited to have received the full data set from our Phase 3 STAR-1 trial of XYNGARI™ showing that XYNGARI™ achieved statistically significant results for its three co-primary endpoints at weeks 4 and 12," commented Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. "We believe these data show that not only does XYNGARI™ work after the FDA required 12-week primary endpoint, but it also works as early as week four, which was the earliest measured timepoint. We strongly believe if consumers are able to gain access to our Spongilla technology acne patients will experience the many unique benefits our product candidate can offer, and our team continues to work hard to make this happen," concluded Mr. Proehl.
Corporate Highlights
Announced positive topline data from its XYNGARI™ Phase 3 STAR-1 clinical trial in moderate-to-severe acne. In March 2025, Dermata announced that its STAR-1 study met all three primary endpoints by producing highly statistically significant results versus placebo at the end of study. In April 2025, Dermata also announced that XYNGARI™ achieved statistically significant separation from placebo after just 4 weeks, or only four treatments. STAR-1 is the first of two Phase 3 clinical trials, the second of which would be followed by a long-term extension study, which the Company would need to complete prior to filing a new drug application with the U.S. Food and Drug Administration.
Raised
$8.8 million in gross proceeds during the first half of 2025. The funds raised during the first half of 2025 are expected to fund its operations into the second quarter of 2026.
Anticipated Upcoming Milestones
Second XYNGARI™ Phase 3 STAR-2 clinical trial in moderate-to-severe acne. With positive results from the STAR-1 trial, the Company initiated additional manufacturing and is evaluating next steps with respect to the XYNGARI™ Phase 3 STAR-2 clinical trial. The STAR-2 trial would be followed by a 9-month extension study.
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.
Second Quarter 2025 Financial Results
As of June 30, 2025, the Company had
Research and development expenses were
General and administrative expenses were
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™, recently achieved positive data in its first Phase 3 clinical trial 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™ 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 aesthetic applications and medical skin diseases like hyperhidrosis, acne, and rosacea. 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 initiate a clinical trial and 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.
Balance Sheets
June 30, 2025 | December 31, 2024 | |||||||
In thousands USD | (unaudited) | |||||||
Assets | ||||||||
Cash and cash equivalents | $ | 6,481 | $ | 3,162 | ||||
Prepaid expenses and other current assets | $ | 160 | 372 | |||||
Total assets | $ | 6,641 | 3,534 | |||||
Liabilities | ||||||||
Accounts payable | $ | 414 | 808 | |||||
Accrued liabilities | $ | 612 | 1,165 | |||||
Total liabilities | $ | 1,026 | 1,973 | |||||
Equity | $ | 5,614 | 1,561 | |||||
Total liabilities and equity | $ | 6,640 | $ | 3,534 | ||||
DERMATA THERAPEUTICS, INC.
Statements of Operations
(unaudited)
Quarter Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
In thousands, except share and per share data | ||||||||||||||||
Operating expenses | ||||||||||||||||
Research and development (1) | $ | 618 | $ | 2,009 | $ | 1,899 | $ | 3,610 | ||||||||
General and administrative (1) | 1,155 | 875 | 2,214 | 2,477 | ||||||||||||
Total operating expenses | 1,773 | 2,884 | 4,113 | 6,087 | ||||||||||||
Loss from operations | (1,773 | ) | (2,884 | ) | (4,113 | ) | (6,087 | ) | ||||||||
Interest income, net | 72 | 55 | 108 | 124 | ||||||||||||
Net loss | $ | (1,701 | ) | $ | (2,829 | ) | $ | (4,005 | ) | $ | (5,963 | ) | ||||
Net loss per common share, basic and diluted | $ | (1.66 | ) | $ | (41.82 | ) | $ | (5.18 | ) | $ | (106.44 | ) | ||||
Weighted average common shares outstanding, basic and diluted | 1,026,506 | 67,654 | 772,397 | 56,025 | ||||||||||||
(1) Includes the following stock-based compensation expense | ||||||||||||||||
Research and development | $ | 8 | $ | 5 | $ | 16 | $ | 242 | ||||||||
General and administrative | $ | 31 | $ | 15 | $ | 61 | $ | 365 | ||||||||
Investors:
Cliff Mastricola
Investor Relations
cmastricola@dermatarx.com
SOURCE: Dermata Therapeutics
View the original press release on ACCESS Newswire
FAQ
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