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(Incorporated in Delaware)
We are a clinical biotech working to develop an oral treatment – called VDPHL01 – for pattern hair loss (PHL) in men and women in Phase II and Phase III clinical trials. VDPHL01 is an oral extended-release (ER) formulation of minoxidil, which was originally designed to treat resistant hypertension.
We are currently dosing patients with VDPHL01 in our registration-directed clinical program consisting of three pivotal multi-center randomized double-blind, placebo-controlled clinical trials: two in male patients and one in female patients with PHL. These trials are designed to support our planned submissions to the FDA for regulatory approval across both male and female patient populations through a 505(b)(2) New Drug Application, or NDA. We have fully enrolled the first of these registration-directed clinical trials, a Phase 2/3 trial evaluating VDPHL01 in 519 male patients with mild-to-moderate PHL. This first trial assesses two dose regimens of VDPHL01 over 52 weeks of treatment.
We have also initiated our confirmatory registration-directed Phase 3 trial targeting the enrollment of 498 male patients with mild-to-moderate PHL and our registrational-directed Phase 2/3 trial targeting the enrollment of 552 female patients with mild-to-moderate PHL.
If approved, we believe VDPHL01’s commercial potential would be substantial. We estimate that the current U.S. commercial opportunity for PHL treatments for men and women is valued at about $9 billion annually, despite low patient engagement and high levels of dissatisfaction with current options reported.
We believe that our efforts mark the first attempt to bring an ER formulation of minoxidil to patients with these optimized pharmacokinetic, or PK, and pharmacodynamic, or PD, qualities that raise the ceiling of hair growth.
More from the prospectus:
We are a dermatologist-founded late clinical-stage biopharmaceutical company focused on developing innovative therapeutics to address pervasive treatment challenges in highly prevalent aesthetic and dermatological conditions. Our initial focus is developing better treatments for pattern hair loss, or PHL, a condition affecting about 50 million men and 30 million women in the United States. Current PHL treatment options are limited and therefore are consistently plagued with high rates of treatment failure, patient dissatisfaction and treatment discontinuation. Patients and healthcare providers routinely identify the following shortcomings with currently available treatment options: (1) Slow onset of hair growth (2) Inconsistent results (3) Insufficient density of hair growth for patient satisfaction (4) Tolerability issues related to hormonal, mood and cardiac side effects (5) Inconvenient administration and (6) Limited U.S. Food and Drug Administration, or FDA, approved treatment options, and no FDA-approved oral options for women.
We are developing VDPHL01 as an oral non-hormonal treatment for men and women with PHL to reduce the barriers to wide adoption of chronic hair loss therapy and potentially transform PHL treatment. We believe that a marketing application could initially seek approval in male patients, followed by a supplemental new drug application, or sNDA, for female patients, or could alternatively pursue approval in both male and female patients simultaneously depending on the timing of the completion of our clinical trials.
VDPHL01 is an oral extended-release, or ER, formulation of minoxidil, a proven hair growth agent, designed to maximize minoxidil’s impact on hair restoration while minimizing the risk of cardiac activity. Though immediate-release, or IR, oral minoxidil was originally designed to treat resistant hypertension, it has been used off label as a treatment for PHL after hair growth was observed as a side effect. However, IR oral minoxidil’s release profile was not designed for hair growth as its short duration of circulation allows less time for follicular saturation and must be used at lower doses to reduce the likelihood of reaching off target cardiac stimulative levels. VDPHL01 builds on minoxidil’s validated hair growth biology via a novel and proprietary ER formulation designed to maximize the total plasma concentrations of minoxidil known to grow hair without inducing changes in cardiac activity.
Note: Net loss figure is for the 12 months that ended Sept. 30, 2025.
Note: The company has no product revenue, according to the prospectus. This is typical for a clinical biotech going public.
(Note: Veradermics, Inc. filed its S-1 for its IPO on Jan. 9, 2026, without disclosing the terms. Estimated proceeds are $100 million, a placeholder figure.)
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