(CercleFinance.com) – GenSight Biologics soars on the Paris Stock Exchange on Monday morning after announcing that it had successfully produced a batch of its gene therapy intended for blind patients.
The biopharmaceutical company reported this morning that its manufacturing partner in the United States had successfully produced a batch of Lumevoq, its investigational treatment for Leber’s hereditary optic neuropathy (LHON).
This batch could be available in the 1st quarter of 2024 with a view to a potential resumption of the early access program and the launch of a possible new clinical trial to obtain additional data for future regulatory submission.
The manufacture of a second batch aimed at providing more doses available to patients is also underway, underlines GenSight, which anticipates viral titer results in October 2023.
This reassuring point on production comes as the company reported on Friday, on the occasion of the publication of its first half financial results, a cash flow that was ‘tight’ to say the least in the opinion of analysts.
As of June 30, cash and cash equivalents stood at just one million euros, an amount sufficient to ensure its financing until October 2023.
GenSight specifies, however, that its cash flow horizon could be extended until December 2023 with the drawing of a second tranche of financing for an amount of four million euros.
The biotech also plans to seek other sources of debt or equity financing to finance its operations beyond December 2023.
‘The return of the European Medicines Agency (EMA) will be decisive in defining the future of Lumevoq knowing that the EMA’s report could make it possible to extend funding beyond 2024’, react analysts from Degroof Petercam, who put their opinion on the title ‘under review’.
GenSight decided, in April, to withdraw its European marketing authorization application for Lumevoq with the aim of initiating discussions with the EMA on the best possible path for its candidate.
After soaring 95% at the start of the morning, the stock only rose 50% at the end of the morning, which does not prevent it from still suffering losses of 80% this year.