Delays to GenSight Biologics’ eye disease gene therapy are leading toward a cash crunch. With the cash runway due to end early next year and Lumevoq still being reviewed in Europe, GenSight is looking into “several financing options” to enable it to launch the gene therapy in 2023.
GenSight filed for European Medicines Agency (EMA) approval of Lumevoq to treat vision loss in patients with Leber hereditary optic neuropathy back in 2020 and went into the following year aiming to launch the gene therapy at the beginning of 2022. Manufacturing issues caused the timeline to slip throughout last year. With each delay, the anticipated launch date slipped closer to the forecast end of the cash runway.
In November, GenSight requested a nine-month extension to the clock stop on the EMA review. At the same time, GenSight predicted its cash runway would extend to mid-2023. In January, GenSight revised the end of its runway to the first quarter of 2023 and penciled in the launch for early in the quarter.
Now, the two timelines have crossed. Friday, the company tweaked its cash runway, warning investors that it now expects its financial reserves to last until early in the first quarter of 2023. GenSight also reset its target for the launch of Lumevoq to some time in 2023.
Having ended 2021 with 44.3 million euros ($48.2 million), GenSight is “assessing several financing options, non or as little dilutive as possible, to ensure a successful European commercial launch of Lumevoq in 2023,” Chief Financial Officer Thomas Gidoin said in a statement. GenSight’s stock is trading at 2.20 euros in Paris, down 60% on the start of the year.
The big drop in the stock came earlier this week, when GenSight revealed the manufacturing delay that exacerbated its financial worries. GenSight’s most recent manufacturing campaign failed to deliver drug substance that met the viral genome titer acceptance threshold, forcing it to make changes that will push back the resumption of the campaign until the fourth quarter.