Botanix Pharmaceuticals Limited [ASX: BOT} has just reported the commencement of patient treatment in its Phase 1b psoriasis study. The study is being undertaken in collaboration with BioSkin GmbH, a German clinical contract research organisation based in Hamburg, and an Australian dermatology clinic. Data from this study is expected to be available in 3 to 4 months’ time.
Botanix is rapidly progressing and materially de-risking its synthetic cannabidiol (CBD) based treatments for psoriasis [BTX 1308] , Acne [BTX1503] and Atopic Dermatitis [BTX 1204]. The company is also collaborating with the University of Queensland to study CBD effectiveness as a topical antibiotic.
Botanix’s acne treatment [BTX 1503} is progressing as a Stage 2 clinical trial, which is expected to complete in mid CY 2019 with results available in 3Q CY 2019. Positive patient testimony from one of the first patients enrolled in the BTX 1503 trial has been reported while the preceding Phase 1a study indicated no adverse side effects and greater efficacy that leading acne treatments.
A Stage 2 clinical trial for the Atopic Dermatitis treatment [BTX1204] is currently pending. Botanix is targeting US markets for all of its products and has consensus from the FDA that pending results, the overall drug development plans for BTX 1204 will be sufficient to support a New Drug Application (NDA).
Botanix has an exclusive license to use a proprietary drug delivery system (PermetrexTM) for direct skin delivery of active pharmaceuticals in all skin diseases. All Botanix topical treatments utilise PetmetrexTM.
Botanix currently has a market capitalisation of approximately A$63m. At the end of September 2018 the company held A$14.2m in cash with approximately A$4m R&D tax refund expected in 4Q CY2018. The current quarter cash outflow is expected to be A$5.35m (including a A$4.75m on R&D). The high current cash outflow reflects rapid clinical and regulatory progress on all fronts and triggers some juicy R&D tax refunds from the ATO in the future.
Botanix holds relevant patents over its treatments and is the only company to advance CBD treatment of skin conditions into clinical trials. In view of the global market for any new gold standard treatments for psoriasis, acne and atopic dermatitis potential value to shareholders of positive phase 2 clinical results is at blue sky levels.