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April 21 , 2021 poxel Poxel Provides Corporate Update and Reports Cash and Revenue for the First Quarter 2021 • Imeglimin Japanese New Drug Application ( J - NDA ) under review by the Pharmaceuticals and Medical Devices Agency ( PMDA ) following submission by Poxel's partner , Sumitomo Dainippon Pharma in July 2020 , with product launch anticipated in 20211 • Poxel regained Imeglimin rights from Metavant for US , Europe and other countries not covered by its agreement with Sumitomo Dainippon Pharma and is pursuing next steps to advance its development including partnering activities • Poxel continues to prepare for initiation of Phase 2b trial with PXL770 in patients with biopsy - proven NASH and pre - diabetes or type 2 diabetes , expected to commence in H2 2021 • PXL065 Phase 2 study ongoing with completion of recruitment expected in mid- 2021 and topline data readout in mid - 2022 • Imeglimin and PXL065 preclinical and clinical data published in peer reviewed journals ; PXL770 data accepted for oral and poster presentations at an upcoming scientific conference • As of March 31 , 2021 , cash and cash equivalents were EUR 32.8 million ( USD 38.4 million ) LYON , France -- ( BUSINESS WIRE ) -- POXEL SA ( Euronext : POXEL - FR0012432516 ) , a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders , including type 2 diabetes and non - alcoholic steatohepatitis ( NASH ) , today provided a corporate update and announced its cash position and revenue for the first quarter ended March 31 , 2021 . " Closing the first quarter of 2021 , we remain on track with our corporate and clinical timelines and objectives . We look forward to the completion of the J - NDA review of Imeglimin , and based on a typical 12 - month review by the PMDA , we believe Imeglimin could be approved in mid - 2021 with an anticipated product launch by our partner Sumitomo Dainippon Pharma in Fiscal Year 20211. Further , having regained Imeglimin rights from Metavant in the US , Europe and other countries not covered by our agreement with Sumitomo , we are pursuing various opportunities to advance its development including partnering activities , " commented Thomas Kuhn , CEO of Poxel . " Our NASH candidates , PXL770 and PXL065 continue to move forward . For PXL770 , we are actively preparing for a Phase 2b trial in biopsy - proven NASH patients with a focus on