Earnings release
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GenSight BIOLOGICS Press Release GenSight Biologics Reports Cash Position as of March 31 , 2021 and Provides Operational Update - Paris , France , April 20 , 2021 , 7.30 am CEST - GenSight Biologics ( Euronext : SIGHT , ISIN : FR0013183985 , PEA - PME eligible ) , a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders , today reported its cash position as of March 31 , 2021 , and provided an operational update . " We enter the final stretch of LUMEVOQ's registration phase in a very strong financial position , " commented Bernard Gilly , Chief Executive Officer of GenSight Biologics . “ This allows us to approach the coming commercial launch of LUMEVOQ in Europe with confidence while pushing forward in the US and accelerating our GS030 clinical development . " Cash position and financing runway GenSight Biologics ' cash and cash equivalents totaled € 61.1 million as of March 31 , 2021 , compared to € 37.9 million as of December 31 , 2020 . The operating cash burn in the first quarter of 2021 mainly reflects the conduct of the REFLECT Phase III clinical trial of LUMEVOQⓇ in the treatment of Leber Hereditary Optic Neuropathy , as well as the PIONEER Phase I / II trial of GS030 in the treatment of Retinitis Pigmentosa . The Company also focused on the final pharmaceutical development steps for LUMEVOQⓇ in preparation for the European marketing authorization expected in Q4 2021. These were mainly preparatory activities to ensure manufacturing readiness to commercialize under Good Manufacturing Practices ( GMP ) . The operating cash burn was more than offset by the net proceeds from the oversubscribed € 30 million private placement in March . The Company also recorded revenues from the sale of LUMEVOQⓇ under a Temporary Authorization for Use ( ATU ) in France amounting to € 3.9 million in the first quarter of 2021 compared to € 0.7 million in the first quarter of 2020 and a total of € 4.4 million in 2020.1 " With a successful oversubscribed € 30 million private placement in March , in addition to revenues generated by ATUS in France , we have now extended the runway to at least Q2 2023 , " commented Thomas Gidoin , Chief Financial Officer of GenSight Biologics . " We continue to concentrate on transitioning GenSight Biologics into a commercial company ahead of LUMEVOQ's launch in Europe expected early next year . " Temporary Authorization for Use ( ATU ) of LUMEVOQⓇ Additional patients were treated with LUMEVOQⓇ in the first quarter under a Temporary Authorization for Use ( ATU ) granted by the French National Drug Safety Agency ( Agence Nationale de Sécurité du Médicament or ANSM ) . Additional ATUs have been requested by the CHNO of the Quinze - Vingts in Paris . 1 The Company elected to account for a variable consideration in accordance with IFRS15 to reflect the uncertainty of the actual net commercial price that will be obtained after negotiation with the French public payer . Any difference with the initial ATU price would then have to be repaid . The variable consideration is assessed by using an expected value method based on a range of probability - weighted net prices and discounted at market rate . Further detail is provided in sections 7 and 18 of the 2020 Universal Registration Document .