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GENKYOTEX PROVIDES BUSINESS UPDATE FOR Q22017

  • Phase 2 PBC trial initiated in the United States
  • Phase 2 IIT trial in DKD fully funded by JDRF and Baker Institute
  • Cash & cash equivalents and liquid investments of €18.1 million as ofJune 30th

Genkyotex (Euronext Paris & Brussels: FR00011790542 – GKTX), a biopharmaceutical company and the leader in NOX therapies, today provided acorporate update. It also announced that its cash & cash equivalents and liquid investments position for the second quarter ended June 30th, 2017 is €18.1 million, not including anticipated tax credit for 2016.

Clinical highlights

  • On May 2nd, 2017, the Company announced that the U.S. Food & Drug Administration (FDA) had accepted its Investigational New Drug (IND) Application, allowing Genkyotex to proceed with a phase 2 clinical trial of GKT831, its first-in-class NOX1 and NOX4 inhibitor, in patients with primary biliary cholangitis (PBC).
  • On June 27th, 2017, the Company announced the enrollment initiation for the trial at the first investigational center in the United States. In total, over 50 centers across the United States, Canada, Belgium, Germany, Greece, Italy, Spain, UK, and Israel are anticipated to participate in the trial. Interim top-line results are expected in the first half of 2018, followed by the full results in the second half of 2018.
  • On June 28th, 2017, Genkyotex announced that two world-renowned diabetes experts, Professor Mark Cooper, Head of the Department of Diabetes at Monash University, and Professor Jonathan Shaw, Deputy Directorat the Baker Heart and Diabetes Institute (both in Melbourne, Australia), will lead an investigator-initiated phase 2 clinical trial to evaluate the efficacy and safety of the Company’s lead product candidate, GKT831, in diabetic kidney disease. This research is financially supported by JDRF Australia, the recipient of the Australian Research Council Special Research Initiative in Type 1 Juvenile Diabetes funding, with additional financial support by the Baker Institute. Genkyotex shall provide GKT831 Good Manufacturing Practice (GMP) material for the trial.Patient enrollment is expected to begin in the second half of 2017.

Research highlights

Genkyotex continues to explore the therapeutic value of NOX inhibition in oncology, hearing loss and Parkinson’s disease and to seek opportunities of non-dilutive grant financing to support the preclinical evaluation of drug candidates in these therapeutic areas.

Financial highlights 

AtJune30th, 2017, Genkyotex’ cash & cash equivalents and liquid investments stood at€18.1 million vs.€21.8 million at March 31st, 2017,in line with the Company’s expectations and mainly driven by the set-up of the phase 2 trial in PBC with GKT831 and the ongoing preclinical work on GKT771. The cash position does not include an expected reimbursement of Research Tax Credit (CréditImpôtRecherche) for 2016, estimated by the Company to be at €3 million.

Elias Papatheodorou, CEO of Genkyotex, comments: “We are proud of our accomplishments over the first half of 2017. The clinical development of GKT831 is broader than initially announced at the beginning of the year. In addition to the PBC phase 2 trial, we also announced a second phase 2 trial for GKT831 in DKD, fully funded by JDRF and Baker Institute. We are confident in both the medical potential of our therapies and in our ability to potentially bring them closer to patients suffering from fibrotic diseases.”