GenSight Biologics is weeks away from running out of money. Again. The biotech only has enough cash to fund operations into mid-November and, with a revenue stream set to start later than planned, needs bridge financing to survive.
GenSight’s position, teetering on the edge of the financial abyss, is a familiar one for the Parisian gene therapy biotech. One year ago, the company was in almost the same position as it is today, with its cash set to run out in mid-November 2023. GenSight averted that crisis but only bought itself a little time. On March 22, the biotech told investors it only had enough cash to keep going until the end of April.
The biotech worked through the crises in the belief a more lasting solution is on the horizon. GenSight used to provide its eye disease gene therapy Lumevoq in France through a compassionate use scheme. The biotech generated 3.1 million euros ($3.4 million) from one quarter in the scheme in 2022.
In January 2023, GenSight said it was aiming to resume supply to the scheme in the second quarter of that year. The importance of compassionate use revenues increased when GenSight withdrew a filing for approval of Lumevoq in Europe in April 2023, but it has taken longer than expected to resume supply.
One month ago, GenSight told investors it expected to resume supply in the fall. While the timing was tight, with the cash runway set to end in mid-November, the biotech expected to start generating sales in time to survive on its existing resources. GenSight said its runway would extend into the third quarter of 2025 with the support of the compassionate use sales.
Thursday, the biotech revealed its cash will run out before the revenue stream kicks in. GenSight plans to file a request with the regulator to resume supply around the middle of November and inject the first patient by the end of 2024. Based on that timeline, GenSight expects to receive its first payment in late December or early January.
The timeline means GenSight needs bridge financing to keep the lights on until it starts to generate cash from the compassionate use scheme. If investors step up, the biotech calculates its runway will extend to the fourth quarter of 2026. GenSight said it is in active talks with investors and has received waivers from its creditors.
Amid the cash crunches, GenSight has continued to plan a phase 3 trial that could support a second bid for approval of Lumevoq in Leber hereditary optic neuropathy. However, the biotech needs financing or a partner to start the study.