UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01. Other Events.
On September 10, 2025, Dermata Therapeutics, Inc. (the “Company”) issued a press release disclosing the Company’s strategic pivot to prioritize the development and distribution of over-the-counter (“OTC”) pharmaceutical dermatology focused products that can be sold directly to consumers. The Company plans to initially focus on developing a once weekly acne kit that utilizes an approved OTC monograph active ingredient along with the Company’s Spongilla technology. The Company plans to launch its initial acne kit in the middle of 2026 with additional product candidates anticipated to follow. As part of the Company’s strategic shift into the OTC marketplace, it has withdrawn its investigational new drug application for XYNGARI™ with the U.S. Food and Drug Administration.
Forward-Looking Statements
This Current Report on Form 8-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as “aims,” “anticipates,” “believes,” “could,” “expects,” estimates,” “intends,” “may,” “plans,” “potential,” “projects,” “should,” “will,” and “would,” or similar references to future periods. Examples of forward-looking statements in this Current Report on Form 8-K include, without limitation, statements related to: Dermata’s shift to prioritize OTC dermatology products; the anticipated benefits of the strategic shift; the anticipated benefits of Dermata’s strategic shift to OTC products, including acceleration of its path to commercialization, reduction of regulatory burdens, and expansion into broader consumer markets; the expected timing and success of any planned or future OTC product launches; and other factors described in the Company’s filings with the Securities and Exchange Commission. Any forward-looking statements in this Current Report on Form 8-K are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in or implied by the forward-looking statements, see the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission as well as discussions of potential risks, uncertainties and other important factors in any subsequent Company filings with the Securities and Exchange Commission. All information in this Current Report on Form 8-K is as of the date of the filing; the Company undertakes no duty to update this information unless required by law.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| DERMATA THERAPEUTICS, INC. | ||
| Dated: September 10, 2025 | By: | /s/ Gerald T. Proehl |
| Name: | Gerald T. Proehl | |
| Title: | Chief Executive Officer | |