Dermata Therapeutics Provides Corporate Update and Reports First Quarter 2025 Financial Results
Dermata Therapeutics (NASDAQ: DRMA) reported significant progress in Q1 2025, highlighted by positive topline results from its XYNGARI™ Phase 3 STAR-1 clinical trial for moderate-to-severe acne treatment. The trial achieved all three co-primary endpoints with statistical significance versus placebo, showing efficacy after just 4 weeks. The company also entered into a Clinical Trial Collaboration Agreement with Revance to study DMT410 with DAXXIFY® for axillary hyperhidrosis treatment.
Financially, Dermata raised $8.8 million in gross proceeds during Q1 2025, ending the quarter with $9.7 million in cash. R&D expenses decreased to $1.3 million from $1.6 million year-over-year, while G&A expenses reduced to $1.1 million from $1.6 million. The company expects current cash resources to fund operations into Q1 2026.
The company plans to initiate its second Phase 3 STAR-2 trial by end of 2025 and is in partnership discussions for XYNGARI™.Dermata Therapeutics (NASDAQ: DRMA) ha riportato progressi significativi nel primo trimestre del 2025, evidenziati dai risultati positivi principali del trial clinico di Fase 3 STAR-1 di XYNGARI™ per il trattamento dell'acne da moderata a grave. Lo studio ha raggiunto tutti e tre gli endpoint co-primari con significatività statistica rispetto al placebo, dimostrando efficacia già dopo 4 settimane. L'azienda ha inoltre stipulato un accordo di collaborazione per studi clinici con Revance per studiare DMT410 insieme a DAXXIFY® nel trattamento dell'iperidrosi ascellare.
Dal punto di vista finanziario, Dermata ha raccolto 8,8 milioni di dollari di proventi lordi nel primo trimestre del 2025, chiudendo il periodo con 9,7 milioni di dollari in cassa. Le spese per Ricerca e Sviluppo sono diminuite a 1,3 milioni rispetto a 1,6 milioni dell'anno precedente, mentre le spese generali e amministrative si sono ridotte a 1,1 milioni da 1,6 milioni. L'azienda prevede che le risorse finanziarie attuali sosterranno le operazioni fino al primo trimestre del 2026.
La società prevede di avviare il secondo trial di Fase 3 STAR-2 entro la fine del 2025 ed è in trattative di partnership per XYNGARI™.
Dermata Therapeutics (NASDAQ: DRMA) reportó avances significativos en el primer trimestre de 2025, destacando los resultados positivos principales de su ensayo clínico de Fase 3 STAR-1 de XYNGARI™ para el tratamiento del acné moderado a severo. El ensayo logró los tres puntos finales co-primarios con significancia estadística frente a placebo, mostrando eficacia tras solo 4 semanas. La compañía también firmó un acuerdo de colaboración para ensayos clínicos con Revance para estudiar DMT410 junto con DAXXIFY® para el tratamiento de la hiperhidrosis axilar.
En cuanto a las finanzas, Dermata recaudó 8,8 millones de dólares en ingresos brutos durante el primer trimestre de 2025, terminando el trimestre con 9,7 millones en efectivo. Los gastos de I+D disminuyeron a 1,3 millones desde 1,6 millones interanual, mientras que los gastos generales y administrativos se redujeron a 1,1 millones desde 1,6 millones. La compañía espera que los recursos de efectivo actuales financien las operaciones hasta el primer trimestre de 2026.
La empresa planea iniciar su segundo ensayo de Fase 3 STAR-2 para finales de 2025 y está en conversaciones de asociación para XYNGARI™.
Dermata Therapeutics (NASDAQ: DRMA)는 2025년 1분기에 중대한 진전을 보고했으며, 그 중 중등도에서 중증 여드름 치료를 위한 XYNGARI™ 3상 STAR-1 임상시험의 긍정적인 주요 결과가 두드러졌습니다. 이 임상시험은 위약 대비 통계적으로 유의미한 세 가지 공동 주요 평가변수를 모두 달성했으며, 단 4주 만에 효능을 입증했습니다. 또한 회사는 액시라 과다발한증 치료를 위한 DMT410과 DAXXIFY®의 임상시험 협력 계약을 Revance와 체결했습니다.
재무적으로 Dermata는 2025년 1분기에 총 880만 달러를 조달했으며, 분기말 현금 잔액은 970만 달러였습니다. 연구개발 비용은 전년 동기 대비 160만 달러에서 130만 달러로 감소했고, 일반관리비도 160만 달러에서 110만 달러로 줄었습니다. 회사는 현재 현금 자원이 2026년 1분기까지 운영 자금을 지원할 것으로 예상합니다.
회사는 2025년 말까지 두 번째 3상 STAR-2 시험을 시작할 계획이며, XYNGARI™에 대한 파트너십 논의를 진행 중입니다.
Dermata Therapeutics (NASDAQ : DRMA) a annoncé des progrès significatifs au premier trimestre 2025, notamment grâce aux résultats positifs principaux de son essai clinique de phase 3 STAR-1 avec XYNGARI™ pour le traitement de l'acné modérée à sévère. L'essai a atteint les trois critères co-primaires avec une signification statistique par rapport au placebo, démontrant une efficacité dès 4 semaines. La société a également signé un accord de collaboration clinique avec Revance pour étudier DMT410 en association avec DAXXIFY® dans le traitement de l'hyperhidrose axillaire.
Sur le plan financier, Dermata a levé 8,8 millions de dollars de produits bruts au premier trimestre 2025, terminant la période avec 9,7 millions de dollars en trésorerie. Les dépenses de R&D ont diminué à 1,3 million contre 1,6 million d'une année sur l'autre, tandis que les frais généraux et administratifs sont passés de 1,6 million à 1,1 million. La société prévoit que les ressources de trésorerie actuelles financeront les opérations jusqu'au premier trimestre 2026.
L'entreprise prévoit de lancer son deuxième essai de phase 3 STAR-2 d'ici la fin 2025 et est en discussions de partenariat pour XYNGARI™.
Dermata Therapeutics (NASDAQ: DRMA) berichtete im ersten Quartal 2025 über bedeutende Fortschritte, insbesondere durch positive Hauptergebnisse der Phase-3-STAR-1-Studie von XYNGARI™ zur Behandlung von mittelschwerer bis schwerer Akne. Die Studie erreichte alle drei gemeinsamen primären Endpunkte mit statistischer Signifikanz gegenüber Placebo und zeigte bereits nach 4 Wochen Wirksamkeit. Das Unternehmen ging zudem eine klinische Studienkooperation mit Revance ein, um DMT410 zusammen mit DAXXIFY® zur Behandlung der axillären Hyperhidrose zu untersuchen.
Finanziell erzielte Dermata im ersten Quartal 2025 Bruttoerlöse von 8,8 Millionen US-Dollar und schloss das Quartal mit 9,7 Millionen US-Dollar an liquiden Mitteln ab. Die F&E-Ausgaben sanken von 1,6 Millionen auf 1,3 Millionen US-Dollar im Jahresvergleich, während die allgemeinen und administrativen Ausgaben von 1,6 Millionen auf 1,1 Millionen US-Dollar zurückgingen. Das Unternehmen erwartet, dass die aktuellen Barmittel die Geschäftstätigkeit bis ins erste Quartal 2026 finanzieren.
Das Unternehmen plant, bis Ende 2025 die zweite Phase-3-STAR-2-Studie zu starten und befindet sich in Partnerschaftsgesprächen bezüglich XYNGARI™.
- Phase 3 STAR-1 trial for XYNGARI™ achieved all primary endpoints with statistical significance
- Demonstrated rapid efficacy with significant results after just 4 weeks of treatment
- Secured $8.8 million in financing, extending cash runway into Q1 2026
- Reduced R&D and G&A expenses compared to previous year
- Strategic partnership with Revance for DMT410 development
- Additional Phase 3 trial (STAR-2) still required before FDA submission
- Cash runway only extends into Q1 2026, may need additional financing
- Currently seeking partnerships for STAR-2 trial funding/commercial rights
Insights
Dermata's positive Phase 3 XYNGARI results and Revance partnership significantly strengthen its clinical and commercial prospects.
Dermata's Q1 update reveals substantial clinical validation for their lead asset XYNGARI™, with the Phase 3 STAR-1 trial achieving all three co-primary endpoints with statistical significance in moderate-to-severe acne. The trial's rapid efficacy (showing separation from placebo after just 4 weekly treatments) positions XYNGARI™ competitively in the acne market if approved. Most notably, this success significantly derisks their upcoming second Phase 3 trial (STAR-2), which is crucial for eventual FDA submission.
The strategic collaboration with Revance to evaluate XYNGARI™ with DAXXIFY® for axillary hyperhidrosis (excessive underarm sweating) represents a valuable pipeline expansion. This partnership leverages Dermata's topical delivery technology with Revance's established botulinum toxin, potentially creating a differentiated needle-free administration option. The collaboration includes potential expansion into additional indications like acne, rosacea, and facial aesthetics, which could substantially increase Dermata's addressable market.
Their improved financial position with $9.7M cash (up from $3.2M at year-end 2024) following an $8.8M raise extends their runway into Q1 2026. This timeline strategically covers their planned STAR-2 trial initiation by end of 2025. With
XYNGARI's Phase 3 success in acne presents a potentially breakthrough once-weekly natural treatment option with rapid efficacy.
The positive Phase 3 STAR-1 results for XYNGARI™ represent a significant clinical advancement in acne therapeutics. Meeting all three co-primary endpoints with statistical significance validates Dermata's unique Spongilla-based approach. What's particularly impressive is the rapid onset of action – showing statistically significant separation from placebo after just four weekly treatments. This suggests XYNGARI™ could address a major unmet need for faster-acting acne therapies.
The once-weekly application regimen, if approved, would offer a substantial compliance advantage over current daily topical treatments. Patient adherence is a well-documented challenge in dermatology, where studies show compliance rates below
The DMT410 collaboration with Revance for hyperhidrosis demonstrates the platform potential of Dermata's technology. Current hyperhidrosis treatments are limited by invasiveness (injectable botulinum toxin) or limited efficacy (topical antiperspirants). A topical delivery system for DAXXIFY® (a long-acting botulinum toxin) could transform treatment paradigms. The mention of potential applications in acne, rosacea, and facial aesthetics further suggests the technology could enable needle-free delivery across multiple dermatological conditions, solving a significant barrier to treatment adoption. The planned second Phase 3 trial with 9-month extension will be crucial for establishing long-term safety and maintenance of effect.
- Dermata announced positive topline results from its XYNGARI™ Phase 3 Spongilla Treatment of Acne Research (STAR-1) clinical trial, achieving all co-primary endpoints -
- Dermata entered into a Clinical Trial Collaboration Agreement with Revance Therapeutics to study DMT410 with DAXXIFY® for the treatment of axillary hyperhidrosis -
- Raised
SAN DIEGO, CA / ACCESS Newswire / May 14, 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 highlighted recent corporate progress and reported financial results for the first quarter ended March 31, 2025.
"It was an exciting quarter for our team to announce positive topline results of the XYNGARI™ Phase 3 STAR-1 trial for the treatment of acne, which achieved statistically significant results of its three co-primary endpoints at all time points," commented Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. "Our team has spent many years working with this product and knew it had strong potential as a treatment for acne and we are happy to see that hard work has paid off with such positive results. We believe the consistent results from our previous clinical studies and this Phase 3 trial derisks the planned second Phase 3 trial and well positions XYNGARI™ to potentially be the first once-weekly, natural, topical treatment for moderate-to-severe acne, if approved. We are also excited to have partnered with Revance to study DMT410 with DAXXIFY® for the topical treatment of axillary hyperhidrosis," continued Mr. Proehl. "We see a lot of potential uses for our DMT410 program and studying it in a Phase 2 study with a long-lasting botulinum toxin, like DAXXIFY®, could provide us with the data needed to show the clinical efficacy of DMT410 aiding in the topical delivery of a botulinum toxin," 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 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, further demonstrating its rapid onset of action. STAR-1 is the first of two Phase 3 clinical trials, the second of which will include a 9-month extension study, which the Company will need to complete prior to filing a new drug application with the U.S. Food and Drug Administration.
Signed Clinical Trial Collaboration Agreement for DMT410 with Revance. In January 2025, Dermata entered into a Clinical Trial Collaboration Agreement with Revance, where Dermata and Revance intend to conduct a Phase 2a trial to evaluate XYNGARI™, Dermata's topical Spongilla product candidate, with DAXXIFY®, Revance's botulinum toxin product, for the topical treatment of axillary hyperhidrosis. If successful, the companies may agree to further clinical development in hyperhidrosis and potentially other indications, like acne, rosacea, and facial aesthetics.
Raised
$8.8 million in gross proceeds during the first quarter 2025. The funds raised during the first quarter 2025 are expected to fund Dermata's operations into the first quarter of 2026.
Anticipated Upcoming Milestones
Initiate the second XYNGARI™ Phase 3 STAR-2 clinical trial in moderate-to-severe acne. With positive results from the STAR-1 trial, Dermata has begun the manufacturing campaign for the STAR-2 trial and plans to initiate the second Phase 3 trial of XYNGARI™ for the treatment of moderate-to-severe acne by the end of 2025. The STAR-2 trial will be followed by a 9-month extension study. Dermata has commenced discussions regarding potential partnerships for the STAR-2 trial and/or commercial rights to XYNGARI™.
Continue preparation of DMT410 Phase 2a clinical study with Revance. Dermata 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.
First Quarter 2025 Financial Results
As of March 31, 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 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 they 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
March 31, 2025 | December 31, 2024 | |||||||
In thousands USD | (unaudited) | |||||||
Assets | ||||||||
Cash and cash equivalents | $ | 9,719 | $ | 3,162 | ||||
Prepaid expenses and other current assets | 286 | 372 | ||||||
Total assets | 10,005 | 3,534 | ||||||
Liabilities | ||||||||
Accounts payable | 1,395 | 808 | ||||||
Accrued liabilities | 1,308 | 1,165 | ||||||
Total liabilities | 2,703 | 1,973 | ||||||
Equity | 7,302 | 1,561 | ||||||
Total liabilities and equity | $ | 10,005 | $ | 3,534 | ||||
DERMATA THERAPEUTICS, INC.
Statements of Operations
(unaudited)
Quarter Ended March 31, | ||||||||
In thousands, except share and per share data | 2025 | 2024 | ||||||
Operating expenses | ||||||||
Research and development (1) | $ | 1,281 | $ | 1,600 | ||||
General and administrative (1) | 1,058 | 1,603 | ||||||
Total operating expenses | 2,339 | 3,203 | ||||||
Loss from operations | (2,339 | ) | (3,203 | ) | ||||
Interest income | 36 | 69 | ||||||
Net loss | $ | (2,303 | ) | $ | (3,134 | ) | ||
Net loss per common share, basic and diluted | $ | (0.45 | ) | $ | (7.06 | ) | ||
Weighted average common shares outstanding, basic and diluted | 5,154,698 | 443,998 | ||||||
(1) Includes the following stock-based compensation expense | ||||||||
Research and development | $ | 8 | $ | 237 | ||||
General and administrative | $ | 29 | $ | 350 | ||||
Investors:
Cliff Mastricola
Investor Relations
cmastricola@dermatarx.com
SOURCE: Dermata Therapeutics
View the original press release on ACCESS Newswire
FAQ
What were the results of Dermata's XYNGARI Phase 3 STAR-1 trial for acne treatment?
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