(AOF) – Pharnext, a biopharmaceutical company at an advanced clinical stage, posted a net loss of 19.10 million euros in the first half of 2022 against 13.55 million at the same time last year. The financial and operational results also remain in the red with losses of 5.86 million and 13.24 million respectively.
R&D expenses increased from 9.9 million in the first half of 2021 to 10.4 million in the first half of 2022, mainly related to the Phase III clinical trial of PXT3003 (Premier trial). These R&D expenses represent 72% of total operating expenses over the period.
Selling, general and administrative expenses increased by 20%, compared to last year, from 3.4 million to 4.1 million, reflecting the restructuring of the workforce in the first half of 2022. The workforce is 28 people at the end of the period, compared to 43 in June 2021. The research tax credit (CIR) decreased to 1.2 million in the first half of 2022, compared to 1.9 million in the first half of 2021.
During the first half of 2022, Pharnext continued to achieve significant milestones in the development of its most advanced product, PXT3003, in CMT1A. The company completed the enrollment of 387 patients with CMT1A in its pivotal Phase III clinical study of PXT3003 (Premier trial) on schedule. The first results should be announced during the fourth quarter of 2023.
In May 2022, Pharnext announced new interim results from the currently ongoing open-label extension study of PXT3003 in CMT1A (PLEO-CMT-FU trial) which suggests a good safety profile and continuation of effect of the treatment evaluated on the ONLS scale (Overall Neuropathy Limitations Scale) which measures functional motor disability, after a total duration of 5 years of clinical trial.
In June, Pharnext entered into a fixed rate loan agreement with Global Tech Opportunities 13 (GTO), a subsidiary of the Alpha Blue Ocean (ABO) group, for a maximum total amount of 12 million with an annual interest rate of 9 .5%.
In August, it announced a 2.5 million bridge loan agreement with Neovacs SA. This announcement was followed in October by that of a broader financing agreement with Néovacs in the amount of 20.7 million, as well as an amended agreement with GTO by which GTO committed to provide up to 26 million in additional convertible bond financing over the period from December 2022 to the end of 2023.
In total, the funding from Neovacs and GTO should enable Pharnext, subject to performance by each party of its obligations, to complete its Phase III trial of PXT3003, the Premier trial, with a cash horizon up to the first quarter of 2024.
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