Veradermics (MANE) Corporate presentation summary

Product rationale and unmet need

• Pattern hair loss affects ~80M people in the U.S., including ~50M men and ~30M women; women have no FDA-approved oral treatment options.

• Topical minoxidil is discontinued by ~86% of users; off-label immediate-release oral minoxidil has dose-dependent cardiac risks and an efficacy ceiling.

• VDPHL01 is an extended-release minoxidil tablet designed to increase hair-follicle exposure while blunting peak concentrations associated with cardiac activity.

• VDPHL01 is designed to maintain levels above the hair-growth threshold twice as long and deliver nearly twice the total minoxidil exposure over 12 hours versus 2.5 mg immediate-release minoxidil.

Male clinical results and safety

• Study 302 enrolled 519 men and Study 304 enrolled 536; both registration-directed trials reported statistically significant results on hair-count and patient-reported co-primary endpoints at Month 6 (p<0.0001).

• Month 6 non-vellus target-area hair-count increases reached 36.4 hairs/cm² across the active arms in Studies 302 and 304.

• In Study 302, Month 12 hair-count increases were 29.7–43.9 hairs/cm²; 48.4%–62.9% reported “improved” or “much improved” hair coverage.

• Both male studies reported no treatment-related serious adverse events or cardiac adverse events of special interest; no clinically significant heart-rate, blood-pressure, or ECG differences versus placebo were reported.

• Study 302 Part B reported no new peripheral-edema cases in the continued-treatment groups, no AE-related discontinuations, and no observed shedding.

Female program

• In Phase 2 Study 207, Month 6 non-vellus hair-count increases were 22.7 and 23.3 hairs/cm² for 4.5 mg QD and BID; ~90% reported “improved” or “much improved.”

• Study 207 reported no serious adverse events, cardiac adverse events of special interest, or clinically significant heart-rate, blood-pressure, or ECG changes.

• Phase 2/3 Study 306 was fully enrolled; Part A topline data were anticipated in 1H27.