Dermata Therapeutics announces strategic pivot to OTC skin care treatments

Dermata Therapeutics (DRMA) announced a strategic pivot to prioritize the development and distribution of over-the-counter pharmaceutical dermatology focused products that can be sold directly to consumers. This decision was informed by the knowledge gained while developing the Company’s Spongilla technology as well as current market dynamics. The Company believes this transition represents a significant landmark in the Company’s mission to deliver patients with safe, effective, and consumer-friendly dermatology products. For over a decade, Dermata has focused on researching and developing innovative treatments for patients worldwide, including XYNGARI, a once-weekly topical product for the treatment of moderate-to-severe acne utilizing the Company’s proprietary Spongilla technology. In March 2025, the Company announce that XYNGARI achieved statistically significant results in the Company’s US Food and Drug Administration Phase 3 Spongilla Treatment Acne Research clinical study for the treatment of moderate-to-severe acne. Following the completion of the STAR-1 trial and in light of the growing capital requirements, extended regulatory timeline, and everchanging dermatology insurance landscape for prescription drug development, the Company’s management, in agreement with its board of directors, has decided to shift the Company’s strategic focus toward developing and distributing OTC pharmaceutical dermatology products. The Company believes this repositioning through leveraging FDA’s OTC monograph pathway, may accelerate Dermata’s path to commercialization, reduce its regulatory burden, and give it access to a broader customer base not limited by insurance coverage. This pivot is designed to address a growing demand for high-quality, scientifically proven OTC pharmaceutical products that empower consumers to manage their skin health independently. Dermata intends to leverage its knowledge in research, development, and regulatory compliance to deliver a robust portfolio of OTC product offerings, aimed at meeting the needs of patients suffering from various diseases, disorders, and conditions of the skin like acne, psoriasis, and seborrheic dermatitis. Dermata plans to initially develop a once weekly acne kit that utilizes an approved OTC monograph active ingredient along with its Spongilla technology, to reach the almost 50 million US patients with acne. The Company plans to launch this initial acne kit in the middle of 2026 with additional product candidates anticipated to follow.