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 announced its cash position and revenue for the third quarter and nine months ended September 30, 2018.
As of September 30, 2018, cash and cash equivalents were EUR 76.8 million (USD 88.8 million). The cash position reported reflects the DeuteRx upfront payment of EUR 6.8 million (USD 8 million) for the acquisition of PXL065 (DRX-065), a clinical-stage program for NASH, and additional programs, including deuterated drug candidates for metabolic, specialty and rare diseases. The companys cash runway extends into 2021 and includes the completion of clinical proof-of-concept studies for NASH for both PXL770 and PXL065.
Poxel reported revenues of EUR 17.5 million for the quarter ended September 30, 2018 and EUR 55.0 million for the nine months ended September 30, 2018 compared with no revenue during the same periods in 2017.
The revenue reflects a portion of the EUR 36 million upfront payment received from Sumitomo Dainippon Pharma relating to the strategic corporate partnership announced on October 30, 2017 and the USD 35 million (EUR 28 million) upfront payment associated with the corporate partnership announced with Roivant Sciences on February 12, 2018 net of Poxels financial contribution to Roivant. In addition, the revenue also reflects the Imeglimin Phase 3 program costs in Japan incurred during the first nine months of 2018 that were re-invoiced to Sumitomo Dainippon Pharma. Both the upfront payment from Sumitomo Dainippon Pharma and re-invoiced costs of the Phase 3 Trials of IMeglimin for Efficacy and Safety (TIMES) program are recognized according to the percentage of completion for this program.
I am very pleased to report that during the third quarter we continued to make substantial progress for Imeglimin in Japan and all three pivotal Phase 3 TIMES trials are now fully enrolled with over 1,100 patients. We are on track for the data readout in 2019, beginning with the TIMES 1 efficacy study readout during the second quarter of 2019. We are continuing to work closely with our partner Sumitomo Dainippon Pharma in preparing for the Japanese New Drug Application submission in 2020, said Thomas Kuhn, CEO of Poxel. For the United States and Europe, we are working closely with Roivant Sciences and Metavant, a company formed by Roivant Sciences to develop innovative therapies for metabolic disorders, on progressing the Imeglimin clinical program, which is initially targeting patients with type 2 diabetes and moderate-to-severe chronic kidney disease (CKD stages 3b/4), and includes a dedicated clinical trial currently ongoing.
For our second program, PXL770, we have also continued to make substantial progress and completed the Phase 1 multiple ascending dose study. We believe that PXL770 has the potential to treat liver diseases, such as NASH, and could have the potential to treat additional metabolic diseases. We are currently preparing for the initiation of a Phase 2a proof-of-concept program in nonalcoholic fatty liver disease (NAFLD) patients who likely have NASH, added Thomas Kuhn. With our recent acquisition of DeuteRxs drug candidate, PXL065 (formerly DRX-065), we are rapidly expanding our presence in NASH and are one of only a few biotech companies with two clinical programs in development in this therapeutic area. The underlying pathophysiological mechanisms that contribute to the development and progression of NAFLD and NASH are highly complex and support the need for the development of novel therapies acting on different targets. Both of our programs, which we plan on advancing into Phase 2 in 2019, have the potential to be developed as a monotherapy or in combination together or with other agents.
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