XYNGARI acne trial favors Dermata (NASDAQ: DRMA) in Phase 3 results

Rhea-AI Filing Summary

Dermata Therapeutics reported new clinical data from its Phase 3 STAR-1 trial of XYNGARI™ (DMT310) for acne, presented in an abstract at the 2025 European Academy of Dermatology and Venereology Congress. In an intent-to-treat analysis, XYNGARI showed statistically significant improvements versus placebo in multiple measures, including Investigator Global Assessment (IGA) treatment success, inflammatory lesion counts, and non-inflammatory lesion counts at weeks 4, 8, and 12.

For IGA treatment success defined as a 2-point reduction and a score of 0 or 1, XYNGARI achieved 29.4% of patients at week 12 compared with 15.2% on placebo. XYNGARI also had greater mean and percent reductions from baseline in both inflammatory and non-inflammatory lesion counts across all time points, supporting a consistent efficacy benefit over placebo in this Phase 3 acne study.

Positive

• Phase 3 STAR-1 trial showed statistically significant superiority of XYNGARI™ over placebo across multiple acne efficacy endpoints at weeks 4, 8, and 12.

Negative

• None.

Insights

Biotech clinical-trials analyst

Phase 3 acne data show consistent, statistically significant benefits for XYNGARI™ over placebo.

The STAR-1 Phase 3 trial in acne evaluated XYNGARI™ (DMT310) versus placebo using standard endpoints such as Investigator Global Assessment (IGA) and lesion counts. In the intent-to-treat population, the company reports statistically significant differences favoring XYNGARI across IGA treatment success and both inflammatory and non-inflammatory lesion measures at weeks 4, 8, and 12.

At week 12, 29.4% of XYNGARI-treated patients met the stricter IGA treatment success definition (2-point reduction and score of 0 or 1), compared with 15.2% on placebo, indicating a clinically meaningful separation. XYNGARI also delivered larger mean and percent reductions from baseline in inflammatory and non-inflammatory lesion counts at every time point, suggesting a robust and durable effect over three months of treatment.

Because these results come from a Phase 3 trial in a prevalent condition like acne, they may be important for the program’s regulatory and commercial prospects if safety and consistency are confirmed in additional data and future disclosures.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Understanding 8-K Material Events →

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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 17, 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 17, 2025, Dermata Therapeutics, Inc. (the “Company”) issued a press release disclosing the Company’s presentation of an abstract at the European Academy of Dermatology and Venereology Congress 2025. The abstract contains clinical data from the Company’s XYNGARI™ (also known as DMT310) Phase 3 Spongilla Treatment of Acne (STAR-1) clinical trial.

In an intent to treat analysis, the Company saw statistically significant differences in IGA treatment success, mean change in inflammatory lesion count, and non-inflammatory lesion count and percent change in inflammatory lesion count, and non-inflammatory lesion count at week 4, 8, and 12 when compared to placebo.

Investigator Global Assessment (IGA): Patients achieving a 2-point reduction AND score of 0 or 1 (“clear” or “almost clear”)

		Week 4				Week 8				Week 12
XYNGARI™ (n=342)			11.9	%			21.6	%			29.4	%
Placebo (n=178)			6.2	%			8.0	%			15.2	%
p-value			P < 0.05				P < 0.001				P < 0.001

Investigator Global Assessment (IGA): Patients achieving a 2-point reduction

		Week 4				Week 8				Week 12
XYNGARI™ (n=342)			14.3	%			26.2	%			34.3	%
Placebo (n=178)			8.4	%			10.2	%			20.1	%
p-value			P < 0.05				P < 0.001				P < 0.001

Mean change from baseline in inflammatory lesion count

		Week 4				Week 8				Week 12
XYNGARI™ (n=342)			-11.4				-14.7				-16.8
Placebo (n=178)			-8.6				-10.9				-13.1
p-value			P < 0.001				P < 0.001				P < 0.001

Percent change from baseline in inflammatory lesion count

		Week 4				Week 8				Week 12
XYNGARI™ (n=342)			41.3	%			52.4	%			59.1	%
Placebo (n=178)			29.5	%			37	%			45.3	%
p-value			P < 0.001				P < 0.001				P < 0.001

Mean change from baseline in non-inflammatory lesion count

		Week 4				Week 8				Week 12
XYNGARI™ (n=342)			-12.4				-15.0				-17.3
Placebo (n=178)			-8.8				-10.4				-12.4
p-value			P < 0.001				P < 0.001				P < 0.001

Percent change from baseline in non-inflammatory lesion count

		Week 4				Week 8				Week 12
XYNGARI™ (n=342)			35.3	%			42.5	%			48.3	%
Placebo (n=178)			25.7	%			30.0	%			34.7	%
p-value			P < 0.001				P < 0.001				P < 0.001

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 17, 2025	By:	/s/ Gerald T. Proehl
	Name:	Gerald T. Proehl
	Title:	Chief Executive Officer

FAQ

What did Dermata Therapeutics (DRMA) disclose in this 8-K filing?

Dermata reported that it issued a press release about an abstract presented at the European Academy of Dermatology and Venereology Congress 2025, containing Phase 3 STAR-1 clinical trial data for its acne candidate XYNGARI™ (DMT310).

What is XYNGARI™ (DMT310) in Dermata Therapeutics acne program?

XYNGARI™ (also known as DMT310) is Dermatas spongilla-based topical treatment candidate for acne, evaluated in the Phase 3 Spongilla Treatment of Acne (STAR-1) clinical trial described in the filing.

How did XYNGARI™ perform on Investigator Global Assessment (IGA) treatment success in the Phase 3 STAR-1 trial?

Using an IGA definition requiring a 2-point reduction and a score of 0 or 1, XYNGARI™ achieved treatment success in 29.4% of patients at week 12, compared with 15.2% for placebo, with the company stating results were statistically significant.

What were the inflammatory lesion results for XYNGARI™ versus placebo in Dermatas STAR-1 trial?

XYNGARI™ showed greater mean reductions in inflammatory lesion counts from baseline than placebo at weeks 4, 8, and 12, and larger percent reductions, such as a 59.1% decrease at week 12 versus 45.3% for placebo, with statistical significance reported.

How did XYNGARI™ affect non-inflammatory acne lesions compared with placebo?

In the Phase 3 STAR-1 trial, XYNGARI™ produced larger mean and percent reductions from baseline in non-inflammatory lesion counts than placebo at weeks 4, 8, and 12, including a 48.3% percent reduction at week 12 versus 34.7% for placebo.

Where were Dermatas XYNGARI™ Phase 3 data presented?

The abstract containing XYNGARI™ Phase 3 STAR-1 acne data was presented at the European Academy of Dermatology and Venereology Congress 2025, according to the companys disclosure.