Los Angeles-based Pelage Pharmaceuticals has secured $120 million in Series B funding to advance its first-of-its-kind topical gel therapy for hair loss, marking one of the largest biotechnology investment rounds in the regenerative medicine space this year. The round was led by prominent venture firms Arch Venture Partners and GV, Google's venture arm, with additional participation from Main Street Advisors, Visionary Ventures, and YK Bioventures.
Novel Mechanism Targets Hair Follicle Stem Cells
Pelage's investigational therapy, designated PP405, employs a unique mechanism of action designed to activate dormant hair follicle stem cells. The topical gel works by blocking proteins that transport pyruvate molecules into cellular mitochondria, where they typically generate energy. This blockade creates a pyruvate buildup within cells, which subsequently increases activity of lactate dehydrogenase, an enzyme that activates hair follicle stem cells.
The company believes this regenerative approach could address significant unmet medical needs, particularly for populations "traditionally underserved" by current treatments, including women and individuals with longstanding hair loss. According to Pelage's estimates, more than 80% of men and 40% of women experience hair loss during their lifetimes.
Limited Treatment Landscape Drives Innovation
The hair loss treatment market remains constrained, with the FDA having approved only two medications for androgenetic alopecia, the most common form of hair loss. These treatments—minoxidil (Rogaine) and finasteride (Propecia)—offer limited efficacy and carry notable side effects. Minoxidil can cause scalp dryness, itching, and flaking, while finasteride has been associated with erectile dysfunction, anxiety, and suicidal thoughts. Only Rogaine is approved for use in women, highlighting the treatment gap Pelage aims to address.
The FDA issued a warning this spring regarding topical finasteride formulations sold by telehealth companies, citing potential safety concerns and further emphasizing the need for safer, more effective alternatives.
Promising Mid-Stage Clinical Results
In June, Pelage reported positive results from a Phase 2 clinical trial involving 78 men and women with androgenetic alopecia. The study enrolled participants with diverse skin tones and hair textures, who received either PP405 gel or placebo applied once daily for four weeks, followed by a two-month evaluation period.
The trial successfully met its primary safety endpoint, demonstrating that the gel was well-tolerated and did not absorb into the bloodstream. More significantly, the study revealed early efficacy signals that distinguished PP405 from existing treatments.
Among men with higher degrees of hair loss, nearly one-third of those receiving the active gel showed greater than 20% increases in hair density at the eight-week mark, compared to no participants in the placebo group achieving this threshold. This rapid response timeline is particularly noteworthy, as visible hair regrowth typically requires six months to a year of continuous therapy with current treatments.
Regenerative Potential Sets Treatment Apart
Perhaps most striking was the therapy's ability to stimulate hair growth from follicles where no hair was previously present—a regenerative capability that existing drugs do not demonstrate. According to Pelage, this finding provides "early validation of its regenerative potential" and suggests the therapy may offer benefits beyond current treatment paradigms.
Strategic Leadership and Future Development
The funding round brings strategic leadership changes, with Cathy Friedman, an adviser for GV's life sciences portfolio who previously led Pelage's $17 million Series A round, appointed as board chair. Richard Heyman, venture partner at Arch Venture Partners, will also join the board alongside CEO Daniel Gil and co-founder and president William Lowry.
Heyman stated that Pelage is "well-positioned" to bring an "accessible for all" therapy to a market lacking treatment options. CEO Daniel Gil noted that the funding "affirms the quality of the company's scientific approach and the clinical results it's gathered."
Pelage plans to present complete trial data at a medical meeting next year and initiate a late-stage study evaluating PP405's safety and efficacy. The substantial funding provides the company with resources to advance through pivotal trials and potentially bring the first regenerative hair loss therapy to market.
