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Pharnext SA reported its fiscal year 2020 results, revealing a net loss of €21.5 million, an improvement from €23.3 million in 2019. The company raised a total of €16.3 million through capital and share warrants to boost funding for its clinical programs, particularly for PXT3003, a treatment for Charcot-Marie-Tooth Type 1A disease. Administrative costs decreased to €8.2 million, and research costs fell to €13.5 million. The total cash position is now €11 million, providing funding until September 2021. The ongoing pivotal Phase III study, PREMIER trial, has commenced enrollment.
Pharnext recently announced the enrollment of the first subject in its pivotal Phase III clinical study (the PREMIER trial) for PXT3003, aimed at treating Charcot-Marie-Tooth disease type 1A (CMT1A). This trial will involve approximately 350 subjects across multiple regions including the U.S. and Europe. The primary efficacy endpoint is the Overall Neuropathy Limitations Scale (ONLS). Successful outcomes may lead to NDA submissions to the FDA and EMA. Notably, Pharnext decided not to pursue a Special Protocol Assessment with the FDA due to operational considerations related to the COVID-19 pandemic.
Pharnext has raised €11 million through a €6 million capital increase and €5 million in convertible bonds. The financing aims to extend the cash runway for advancing PXT3003 into a pivotal phase III trial for Charcot-Marie-Tooth disease Type 1A. Existing shareholders subscribed to the capital raise, which includes warrants allowing further share subscription. Strong interest has been shown for an additional €25 million in convertible bonds over the next 30 months, depending on market conditions. The shareholding structure post-capital raise reveals dilution effects for existing shareholders.
