Trinity Delta Lighthouse: Futura Medical
Trinity Delta view: Futura Medical’s various commercialisation deals will allow for broad geographic availability of MED3000 once launched. Europe partnership(s) are anticipated in the near-term; however, in the key US market, deal timing is likely to be after FDA approval. The FDA will review MED3000 as a De Novo classification with a small confirmatory clinical trial being the only outstanding requirement. This c 100 patient study, known as FM71, began patient enrolment in September 2021 and is expected to complete in Q222. FM71 has a similar mix of mild, moderate, and severe ED patients to the earlier FM57 study but is performed over a 24-week period, compared to a three-month duration for FM57. The aim is to reassure the FDA that efficacy does not diminish over a longer period. A positive trial outcome and subsequent approval would open the door to commercial discussions for the important US market. Our view remains that, whilst not without risks, Futura Medical’s share price does not reflect likely prospects. Our valuation is £264m, equivalent to 92p per share.Futura Medical is engaged in the research and development of pharmaceutical drugs and medical devices and their commercial exploitation. Co. focuses on developing products primarily for the consumer healthcare market. Co.'s focus is on sexual healthcare and pain relief. DermaSys® is Co.'s transdermal technology platform, for the absorption of active molecules through the skin. DermaSys® includes MED2002, a topical gel for the treatment of erectile dysfunction; TPR100, a topical diclofenac pain relief gel; TIB200, a topical ibuprofen pain relief gel; and SPR300, a topical methyl salicylate pain relief gel.
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