Dermata Therapeutics, Inc. reported a net loss of approximately $12.3 million for the fiscal year ending December 31, 2024, compared to a loss of $7.8 million in the previous year. The company's total operating expenses increased to $12.5 million from $8.0 million, primarily driven by a significant rise in research and development costs, which surged by approximately $4.1 million to $8.2 million. This increase was largely attributed to expenses related to the ongoing Phase 3 clinical trials for its lead product candidate, XYNGARI™, which is being developed for the treatment of moderate-to-severe acne. The company has not yet generated any revenue and has an accumulated deficit of approximately $65.7 million as of the end of 2024.

In terms of strategic developments, Dermata has made significant progress with its clinical trials. The company completed patient enrollment for the first of two planned Phase 3 trials for XYNGARI™ in November 2024, with top-line results expected in March 2025. The trial aims to evaluate the efficacy and safety of XYNGARI™ in treating acne, with a focus on reducing inflammatory and non-inflammatory lesions. Additionally, Dermata has entered into a Clinical Trial Collaboration Agreement with Revance Therapeutics to conduct a multi-center Phase 2 clinical trial evaluating the combination of XYNGARI™ with Revance's botulinum toxin product, DAXXIFY®, for the treatment of axillary hyperhidrosis.

Operationally, Dermata's workforce remains small, with only eight full-time employees as of the filing date. The company relies heavily on third-party contract research organizations (CROs) for clinical trials and manufacturing, which poses risks related to compliance and quality control. Dermata's supply chain is also dependent on a single supplier for the raw material used in its products, which could impact production if any disruptions occur. The company has expressed confidence in its supplier's ability to meet its needs but acknowledges the potential risks associated with relying on a sole source.

Looking ahead, Dermata anticipates needing additional capital to fund its operations and clinical development activities. The company has indicated that its existing cash reserves, totaling $3.2 million, will only sustain operations into the third quarter of 2025. As such, Dermata plans to explore various financing options, including public or private equity offerings, to support its ongoing clinical trials and potential commercialization efforts. The company remains focused on advancing its product candidates, particularly XYNGARI™, while navigating the challenges of a competitive and highly regulated pharmaceutical landscape.

About Dermata Therapeutics, Inc.

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