Company Interview / The small cap tackling a big gap in women's health

Key points

Acrux advancing a female testosterone spray for menopausal low libido, targeting a large US market Phase 3 trial planning under way with FDA engagement completed Co-development partner sought within the next quarter to fund most trial costs Existing US generics and hormone replacement products, including Evamist, providing growth platform

Acrux targets US female testosterone opportunity with phase 3 push ,John Warmbrunn from Acrux outlines a strategy centred on a testosterone transdermal spray for menopausal women with low sexual desire. Warmbrunn states that earlier phase 1 and 2 studies indicate strong efficacy and safety, and he sees a potential addressable US market of almost 5 million patients. He adds that demand is already emerging as awareness of testosterone’s role in women’s health grows, particularly around libido, energy, mood, and anxiety.

According to Warmbrunn, Acrux is now preparing for phase 3 trials after re-engaging with the US Food and Drug Administration. He expects phase 3 to begin once a co-development deal with a major pharmaceutical partner is secured, which he targets within the next quarter. Warmbrunn emphasises that long-standing relationships in women’s hormone therapy are creating strong interest from multiple potential partners, who he says are signalling willingness to fund a significant share of phase 3 costs.

Warmbrunn indicates Acrux is not planning a major equity raise, preferring partnership funding to avoid tapping the market for around $20 million. He also highlights a growing US portfolio of recently launched generic products and established hormone replacement therapies, including oestrogen products such as Evamist, which he states are experiencing solid growth.