GenSight Biologics announced on Monday that it had successfully produced a second batch of its Lumevoq gene therapy, which will enable it to obtain a second tranche of financing worth four million euros.

This news boosted its share price by over 13% on Monday morning on the Paris Bourse.

The biopharmaceutical company reports that a preliminary test has confirmed the successful production of a second batch of Lumevoq, its experimental treatment for Leber's hereditary optic neuropathy (NOHL), in compliance with Good Manufacturing Practice (GMP) standards.

Confirmation from an independent laboratory is expected in the next few days, the company states in a press release.

Should this be the case, GenSight would be eligible to draw down the second tranche of the €4 million bridge financing signed this summer with its three historical shareholders (Sofinnova Partners, Invus and UPMC Enterprises).

Its cash horizon would thus be extended to mid-December 2023.

This announcement, which was expected around this time of year, was eagerly awaited by the market and crucial to ensure the company's continuity", Degroof Petercam's analysts pointed out this morning.

GenSight Biologics will, however, have to look for other sources of financing in order to fund its operating expenses until the resumption of Compassionate Access Authorization (CAA), expected in France at the beginning of the second quarter of 2024.

Compassionate access is a system that allows, on a derogatory basis, the use of drugs without marketing authorization to treat serious or rare diseases when no appropriate treatment exists.

GenSight Biologics estimates that it will need around 10 million euros, in addition to the second tranche of bridge financing, to fund its activities until that date.

Following the withdrawal in April of Lumevoq's application for marketing authorization in Europe, the share price has fallen by over 83% since the start of the year.

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