Dermata Therapeutics, Inc. announced that following the Company's receipt of FDA responses to its End of Phase 2 meeting package, the Company's DMT310 Phase 3 clinical development program for the once-weekly topical treatment of patients with moderate-to-severe acne is on track to begin in the second half of 2023. The Company submitted data from its Phase 1 and 2 clinical trials, as well as a nonclinical data package supporting the efficacy, safety, and tolerability of DMT310 for the treatment of moderate-to-severe acne for its Phase 3 clinical development program. FDA provided written responses to the Company's End of Phase 2 meeting package including an agreement that the Company's nonclinical program appears reasonable to support Phase 3 clinical trials, the overall Phase 3 clinical development program appears acceptable for filing a New Drug Application (NDA), the three co-primary endpoints and secondary endpoints proposed in the Phase 3 clinical trial protocols are acceptable, and the completed and planned nonclinical studies would be sufficient to support the submission of an NDA.

Additionally, at the recommendation of FDA, the Company has agreed to include additional safety evaluations (laboratory measurements, electrocardiograms, and an extension study) in the Phase 3 clinical program and plans to submit final updated protocols to FDA shortly. Based on FDA's feedback, the Company anticipates that the Phase 3 clinical program will consist of two independent pivotal trials and an extension study. Each pivotal trial will evaluate the efficacy, safety, andolerability of DMT310 in patients with moderate-to- severe facial acne.

Patients will be treated weekly with DMT310 and will be followed for 12 months to evaluate long-term safety. DMT310 is a novel, once-weekly, topical product candidate derived from a freshwater sponge being developed for the treatment of multiple skin diseases. It 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. DMT310 has previously shown its treatment effect in moderate-to-severe acne in a Phase 2b study where DMT310 applied once weekly, achieved statistically significant results at all timepoints for all primary and secondary endpoints.