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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of
The
Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): September 10, 2025
DERMATA
THERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-40739 |
|
86-3218736 |
| (State
or other jurisdiction |
|
(Commission |
|
(IRS
Employer |
| of
incorporation) |
|
File
Number) |
|
Identification
No.) |
| 3525
Del Mar Heights Rd., #322, San Diego, CA |
|
92130 |
| (Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (858) 800-2543
N/A
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
| ☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of Each Class |
|
Trading
Symbol |
|
Name
of Each Exchange on Which Registered |
| Common
Stock, par value $0.0001 per share |
|
DRMA |
|
The
Nasdaq Capital Market |
| Warrants,
exercisable for one share of Common Stock |
|
DRMAW |
|
The
Nasdaq Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1 933 (17 CFR §230.405)
or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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 |
