PARIS, FRANCE: GenSight Biologics, a biopharma company that develops gene therapies for eye and brain disorders, announced today that it has secured enough cash to operate until mid-February 2024, thanks to cost-cutting measures and ongoing negotiations with some business partners and creditors.
The company also revealed its regulatory and manufacturing progress for its lead product, LUMEVOQ®, a gene therapy for a rare form of blindness.
The company said it needs about €14 million more to fund its activities until July 2024, when it expects to start generating revenues from the early access program (AAC) for LUMEVOQ® in France.
The AAC, which was suspended in March 2023 due to the COVID-19 pandemic, is expected to resume in the third quarter of 2024. The company is currently in talks with existing and potential new investors to raise the required capital.
In addition, the company is exploring various strategic options, including a possible merger, acquisition or licensing deal, to advance its business objectives.
GenSight also shared some positive news on its regulatory and manufacturing front. The company said it received a favorable letter from the UK Medicines and Healthcare products Regulatory Agency (MHRA), which indicated that the company’s clinical data could support a marketing authorisation application in the UK without the need for the upcoming RECOVER trial.
The company plans to file the application in the second half of 2024 and hopes to launch LUMEVOQ® in the UK in 2025.
The company also announced that it successfully produced two batches of LUMEVOQ® under GMP standards and decided to combine them into one larger batch to increase the number of vials available for patients. The company said this will help to meet the expected demand for LUMEVOQ® in France and other countries.
“We are grateful to the MHRA experts for their thoughtful in-depth consideration of the massive amount of clinical and experimental data generated over the past many years,” commented Pr. José-Alain Sahel, Co-founder of GenSight, Distinguished professor and Chairman of Ophthalmology at the University of Pittsburgh School of Medicine (US), Founding Director of the Institut de la Vision, Paris (France).
“It is reheartening to feel hopeful that patients affected with this blinding disease will possibly access the life-changing medicine developed by the teams at the Paris Vision Institute and the GenSight teams over close to twenty years and especially the past decade.”
GenSight raises €30mn in an oversubscribed private placement in EU and US