Poxel Provides Corporate Update and Reports Cash and Revenue for the Third Quarter and Nine Months 2020

  • Imeglimin New Drug Application in Japan (J-NDA) was submitted for the treatment of type 2 diabetes in July 2020 and a target launch is expected in fiscal year 20211; a milestone payment of EUR 4 million was received in Q3 2020 from Sumitomo Dainippon Pharma

  • Imeglimin Phase 3 TIMES results were presented at the 56th European Association for the Study of Diabetes (EASD) meeting; Phase 2b, Phase 3 TIMES results, and additional safety data were presented at the 63rd Annual Meeting of Japanese Diabetes Society (JDS)

  • PXL770 Phase 2a trial for the treatment of NASH met its primary efficacy endpoint and trial objectives, and it was observed to be safe and well tolerated

  • PXL770 profile supports development in NASH and also further evaluation for combination use, as well as utility of adenosine monophosphate-activated protein kinase (AMPK) activation in other chronic and rare metabolic diseases

  • PXL065 Phase 2 trial was initiated in biopsy-proven NASH patients in September 2020; streamlined development with a single Phase 2 trial given knowledge of pioglitazone, including data in NASH, and 505(b)(2) regulatory pathway, which offers the opportunity for an efficient and lower risk development program

  • As of September 30, 2020, cash and cash equivalents were EUR 41.5 million (USD 48.6 million)

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 third quarter and the nine months ended September 30, 2020.

“During the third quarter, we continued to make significant progress and accomplished a number of important clinical and corporate objectives, including reporting positive results from a Phase 2a proof-of-concept trial for PXL770, demonstrating its potential in NASH. These results are the first human clinical assessment of a direct AMPK activator and support longer-term evaluation of important histological endpoints, such as inflammation and fibrosis, and exploring subpopulations for further differentiation. The data also demonstrate that AMPK activation may lead to broader utility for the treatment of other chronic and rare metabolic diseases. In addition, we initiated a streamlined Phase 2 trial for PXL065 in NASH and strengthened our cash position with non-dilutive funding from a milestone payment of EUR 4 million for the Imeglimin New Drug Application (NDA) submission in Japan and the recent PGE loan of EUR 6 million from the French government,” said Thomas Kuhn, CEO of Poxel.

“For the remainder of this year, we expect several upcoming milestones and events including finalization of the PXL770 Phase 2b clinical trial design, presentations for PXL770 and PXL065 at several scientific meetings as well as publishing results in peer-reviewed scientific journals and additional preclinical data related to our AMPK and deuterated-TZD platforms. Furthermore, our partner, Metavant, is in discussions with the U.S. Food and Drug Administration (FDA) regarding the Imeglimin Phase 3 program in type 2 diabetes patients with chronic kidney disease (CKD) stages 3b/4,” added Thomas Kuhn,

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