Journey Medical Corporation Releases Pooled Phase 3 Data From Its MVOR-1 And MVOR-2 Trials Evaluating DFD-29 Demonstrating Emrosi's Statistical Superiority Over Oracea And Placebo In Achieving Investigator's Global Assessment Treatment Success And Reducing Inflammatory Lesion Counts

FDA-approved Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) is available in the United States for the treatment of inflammatory lesions of rosacea in adults

DFD-29 demonstrated superior efficacy in IGA success rates and inflammatory lesion counts versus both placebo and doxycycline (P<0.001 for all comparisons)

Poster Presented on Efficacy of Oral DFD-29, a Low-Dose Minocycline Formulation, in Patients with Rosacea: A Pooled Analysis of Two Phase 3 Trials

 Journey Medical Corporation ("Journey Medical" or "the Company") (NASDAQ:DERM), a commercial-stage pharmaceutical company primarily focused on selling and marketing U.S. Food and Drug Administration ("FDA")-approved prescription pharmaceutical products for the treatment of dermatological conditions, today presented efficacy data from a pooled analysis of the two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea® in Rosacea-1 ("MVOR-1") and Minocycline Versus Oracea in Rosacea-2 ("MVOR-2"), evaluating DFD-29 (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) (or "Emrosi™") for the treatment of inflammatory lesions of rosacea in adults, at the 2025 Fall Clinical Dermatology Conference taking place October 23-26, 2025, in Las Vegas, NV.

"These combined Phase 3 results, demonstrating Emrosi's statistical superiority over both Oracea and placebo in achieving Investigator's Global Assessment ("IGA") treatment success and reducing total inflammatory lesion count, reaffirm the strong efficacy and safety profile that have established Emrosi as an important treatment option for patients with rosacea," said Claude Maraoui, Co-Founder, President, and CEO of Journey Medical Corporation. "As we expand Emrosi's reach and adoption, these data strengthen our position in the growing dermatology market and underscore our commitment to delivering clinically proven therapies that improve patient outcomes. We believe Emrosi has the potential to become the standard of care for rosacea."

Combined Phase 3 Clinical Result Highlights

In the Phase 3 study, 62.7% of subjects treated with DFD-29 achieved IGA treatment success, compared with 39.0% in the Oracea group and 28.2% in the placebo group. The differences between the DFD-29 and both Oracea and placebo were statistically significant, each with a p-value of <0.001. The DFD-29 group also experienced a mean reduction of 19.2 inflammatory lesions from baseline to week 16, versus reductions of 14.8 lesions with Oracea and 11.3 lesions with placebo (p < 0.001 for each comparison).

Combined Phase 3 Clinical Results Summary

	Combined MVOR-1 and MVOR-2 Analysis
	IGA Success at Week 16		Inflammatory Lesion Change at Week 16
DFD-29 (40 mg)	62.7%		-19.2
Oracea (40 mg)	39.0%		-14.8
Placebo	28.2%		-11.3
P-value: DFD-29 versus Oracea	P<0.001		P<0.001
P-value: DFD-29 versus Placebo	P<0.001		P<0.001

A total of 653 subjects across two Phase 3 clinical trials were randomized in a 3:3:2 ratio to receive once-daily treatment with DFD-29, Oracea (Doxycycline Capsules, 40 mg) or placebo for 16 weeks. The primary objective of both studies was to evaluate the safety and efficacy of DFD-29 compared to placebo for the treatment of papulopustular rosacea, with a secondary objective of comparing DFD-29 to Oracea. Both trials met all co-primary and secondary endpoints, demonstrating that DFD-29 was statistically superior to Oracea and placebo in achieving IGA treatment success and reducing total inflammatory lesion count from baseline to week 16. DFD-29 was well tolerated, with no major safety issues or serious adverse events related to the study drug reported in either trial (MVOR-1 and MVOR-2). The incidence and severity of treatment-emergent adverse events ("TEAEs") were comparable across all treatment groups.