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  • 24 October 2019
    Genkyotex provides business update and reports cash position at September 30, 2019

    Genkyotex (Euronext Paris & Brussels: FR0013399474 – GKTX), a biopharmaceutical company and the leader in NOX therapies, announced today cash and cash equivalents of €3.1 million as of September 30, 2019. The existing cash and cash equivalents, including the French research tax credit for 2018 of €0.9 million received subsequent to the close of the third quarter, provide cash runway to end of Q1 2020. 

    Clinical highlights

    During the third quarter of 2019, Genkyotex announced the positive results from post-hoc analyses of its PBC phase 2 trial. In this large trial, setanaxib achieved statistical significance (p=0.02) for the primary endpoint with the 400mg twice a day (BID) versus placebo, after correction of non-normal distribution in the 400mg once a day group. Post-hoc analyses also indicated that advanced patients, defined as baseline liver stiffness ≥9.6 kPa, achieved particularly important reductions in liver stiffness and in markers of cholestatic injury. Specifically, setanaxib 400mg BID achieved marked reductions in gamma glutamyl transpeptidase (GGT) (-32%), alkaline phosphatase (ALP) (-24%), and liver stiffness (-22%) after just 6 months of treatment. Taken together with an excellent safety profile and meaningful improvements in quality of life, these results indicate that setanaxib could become an important novel therapy for PBC patients.

    Company has requested an end of Phase 2 meeting from the US Food and Drug Administration (FDA) to obtain guidance from the agency about the Company’s plans to proceed to Phase 3 with setanaxib in primary biliary cholangitis.

    During the quarter, the Company also announced that:

    • the World Health Organization (WHO) recognized NOX inhibitors as a new therapeutic class while approving the new stem “naxib”. The WHO recommended setanaxib as the international nonproprietary name (INN, or generic name) for GKT831.

    • the United States Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application allowing the initiation of the Phase 2 trial with setanaxib in patients with idiopathic pulmonary fibrosis (IPF) in the coming months.

    Research highlights

    Genkyotex continues to explore the therapeutic value of NOX inhibition in additional therapeutic areas, including oncology. The Company expects to secure non-dilutive grant financing to support its ongoing collaborations with academic partners. During the second quarter of 2019, the Company announced the publication of data in Clinics and Research in Hepatology and Gastroenterology showing that its antifibrotic drug candidate, GKT831, prevents multiple complications of portal hypertension in a preclinical model.

    In addition, two abstracts were accepted for presentation during the upcoming 2019 AASLD Liver Meeting (Boston, November 8-12). Abstract 1283 entitled, “The NOX1/4 inhibitor GKT831 reduces liver stiffness, attenuates cholestasis, and improves quality of life in patients with primary biliary cholangitis,” will be presented by Dr Jonathan Huang (University of Rochester Medical Center, NY, United States) at the Hynes Convention Center, Hall B, November 9, 2pm. Abstract 2152 entitled, “A novel, second generation NADPH oxidases 1 and 4 (NOX1/4) inhibitor attenuates TGF-induced myofibroblast activation in vitro and delays disease progression in a high fat diet-induced NASH model,” will be presented by Dr Philippe Wiesel (Chief Medical Officer, Genkyotex) at the Hynes Convention Center, Hall B, November 11, 8am.

    Financial highlights

    On September 30, 2019, Genkyotex's cash and cash equivalents totaled €3.1 million vs. €4.5 million on June 30, 2019. This amount does not include the receipt of the French research tax credit for 2018 of €0.9 million that was received in October 2019. Genkyotex expects its current resources to support anticipated operations until March 31, 2020 taking into account the facts and assumptions detailed in the note 2.1 “going concern” of the 2019 half year condensed consolidated financial statements.