Dermata Therapeutics Inc (DRMA)

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Dermata Announces Receipt of Type C Meeting Response from the FDA and Submission of DMT310 End of Phase 2 Meeting Package
- FDA agrees that Dermata's CMC procedures and controls support the initiation of Phase 3 studies-

- Dermata also submitted an end of phase 2 meeting package to the FDA -

SAN DIEGO, CA / ACCESSWIRE / April 20, 2023 / Dermata Therapeutics, Inc. (NASDAQ:DRMA)(NASDAQ:DRMAW) ("Dermata" or the "Company"), a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions, today announced that it has received a response from the U.S. Food and Drug Administration ("FDA") to the Company's Type C Chemistry, Manufacturing, and Controls ("CMC") meeting request. The FDA's response stated that the Company has provided documentation of its CMC procedures and controls sufficient to support the initiation of Phase 3 studies. The Company has also submitted an end of phase 2 meeting package to the FDA to discuss clinical requirements to advance DMT310 into Phase 3 development as a treatment for moderate-to-severe acne. The Company expects to receive written feedback on the end of phase 2 meeting package from the FDA by the end of June 2023. Upon agreement with the FDA, the Company plans to initiate the Phase 3 program for acne in the second half of 2023. If the Company is able to successfully complete the Phase 3 program, it believes the results could support submission of a new drug application for DMT310 for the treatment of moderate-to-severe acne.

About Dermata Therapeutics

Dermata Therapeutics is a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions. The Company's lead product candidate, DMT310, is the first product candidate being developed from its Spongilla technology platform. DMT310 is a once-weekly topical product candidate derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action. In addition to acne, DMT310 has been studied for the treatment of psoriasis and rosacea. The Company's second product candidate, DMT410, uses its Spongilla technology as a new method for needle-free intradermal delivery of botulinum toxin for the treatment of multiple aesthetic and medical skin conditions. Dermata is headquartered in San Diego, California. For more information, please visit http://www.dermatarx.com/.