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Genkyotex Provides Corporate Update and Reports Cash Position at September 30, 2018

ARCHAMPS, France--(BUSINESS WIRE)--

  • Phase 2 trial of GKT831 for treatment of PBC enrolled 111 patients, exceeding the initial target of 102 patients
  • Interim efficacy results of Phase 2 PBC study expected early November 2018 and final results Spring 2019
  • Third pre-planned safety monitoring board review meeting expected for end of October.
  • Cash and cash equivalents of €12.8 million as of September 30, 2018 providing cash runway to end Q3 2019
  • Genkyotex to host corporate update meeting around AASLD in San Francisco on November 9, 2018

Regulatory News:

Genkyotex (GKTX.PA) (GKTX.PA) (Euronext Paris & Brussels: FR00011790542 – GKTX), a biopharmaceutical company and the leader in NOX therapies, today provides a business update, including progress around the ongoing Phase 2 study of GKT831 for the treatment of Primary Biliary Cholangitis (PBC), and reports cash and cash equivalents of €12.8 million, at September 30, 2018.

Elias Papatheodorou, CEO of Genkyotex, comments: “The third quarter of 2018 was a very robust quarter for Genkyotex. We completed patient enrollment in our Phase 2 trial with GKT831 in PBC exceeding our original target of 102 patients by enrolling 111 patients and had a second positive DSMB meeting. In addition, we announced that the US NIH awarded an $8.9 million grant to the Company’s academic collaborators to conduct a phase 2 trial of GKT831 with patient with Idiopathic Pulmonary Fibrosis (IPF). Finally, we strengthened our balance sheet and currently have €12.8 million in cash and cash equivalents. We expect a major milestone early November with the announcement of the interim efficacy data from our Phase 2 trial in PBC.”

Clinical highlights:

Patient enrollment completed in Phase 2 trial of GKT831 in patients with PBC

  • The Company announced on September 26th, 2018, the completion of patient enrollment in its Phase 2 trial of GKT831 for the treatment of PBC. The trial enrolled a total of 111 patients, exceeding the initial target of 102 patients. This Phase 2 trial is a 24-week, double-blind, placebo-controlled study, evaluating the safety and efficacy of GKT831 in patients with PBC and inadequate response to ursodeoxycholic acid (UDCA). Randomized patients were allocated to three treatment arms: UDCA plus placebo, UDCA plus GKT831 at 400mg once a day and UDCA plus GKT831 at 400mg twice a day. Genkyotex expects interim results in early November 2018 and final results in Spring 2019.
  • The Company also announced early September 2018 that the independent Safety Monitoring Board (SMB) held its second pre-planned data review meeting and recommended the continuation of the Phase 2 PBC trial without protocol amendment. This second review was based on data collected from 77 randomized patients, including at least 60 patients who had completed their week six visit. Genkyotex intends to initiate an open-label extension study for patients completing the ongoing Phase 2 trial, as the positive safety profile observed to date supports continued treatment with GKT831 beyond the planned 24 weeks. A third pre-planned SMB meeting is expected before the end of this month.
  • Based on its overall profile, the Company believes that GKT831 has significant therapeutic potential in a broad range of chronic diseases, including fragile patient populations. Genkyotex announced, in July 2018, that the United States National Institutes of Health (U.S. NIH) awarded an $8.9 million grant to the Company’s academic collaborators to conduct a clinical trial of GKT831 in patients with IPF, an aggressive lung disease that results in progressive fibrosis of the lungs.

Research highlights:

  • Genkyotex continues to assess the therapeutic value of NOX inhibition in oncology and Parkinson’s disease, and to seek opportunities for non-dilutive grant financing to support the preclinical evaluation of promising drug candidates in these therapeutic areas.
  • In October 2018, the Company announced the presentation of preclinical data showing that GKT831 efficiently targeted cancer associated fibroblasts (CAFs) in prostate cancer and abrogated the pro-tumorigenic influence of the tumor micro-environment. The results were presented by Dr. Natalie Sampson, Division of Experimental Urology, Dept. of Urology, Medical University of Innsbruck, Austria, at ESUR18 – the 25th Meeting of the European Association of Urology (ESUR18, October 5, Poster #P-23).
  • Genkyotex also recently announced that an abstract demonstrating the ability of GKT831 to reverse fibrosis in a MDR2 KO mouse model will be presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) (the Liver Meeting®), taking place in San Francisco, November 9-13, 2018. The poster will be presented on Saturday, November 10 (2:00 pm–7:30 pm; Presenters Available: 5:30 pm–7:30 pm).

Financial highlights:

  • As of September 30, 2018, Genkyotex's cash and cash equivalents amounted to €12.8 million vs. €14.6 million of cash, cash equivalents and liquid investments on December 31, 2017, in-line with the Company’s expectations and sufficient to support the Company’s current strategic plan to the end of Q3 2019. Genkyotex’s cash burn was primarily driven by investments in the ongoing Phase 2 trial of GKT831 in PBC. In Q3 2018, the Company received the upfront payment resulting from the execution of the SIIPL extension agreement, the reimbursement of the French Research tax credit for 2017 of €0.6 million and €4.9 million received as part of the up to €7.5 million in nominal value financing obtained from Yorkville Advisors Global LP through the issuance of convertible notes with warrants attached, announced in August. As of today, 70 convertible notes (OCA) have been converted into shares.

Upcoming event:

  • Genkyotex Corporate Overview, Friday November 9, 2018:

    Genkyotex will provide a corporate update on November 9th, 2018, at the W Hotel San Francisco (181 3rd St, San Francisco, CA 94103), from 6:30 to 8:00 am.

About Genkyotex

Genkyotex is the leading biopharmaceutical company in NOX therapies, listed on the Euronext Paris and Euronext Brussels markets. A leader in NOX therapies, its unique therapeutic approach is based on a selective inhibition of NOX enzymes that amplify multiple disease processes such as fibrosis, inflammation, pain processing, cancer development, and neurodegeneration.

Genkyotex’s platform enables the identification of available small-molecules that selectively inhibit specific NOX enzymes. Genkyotex is developing a pipeline of first-in-class product candidates targeting one or multiple NOX enzymes. The lead product candidate, GKT831, a NOX1 and NOX4 inhibitor is evaluated in a phase 2 clinical trial in primary biliary cholangitis (PBC, a fibrotic orphan disease) and in an investigator-initiated Phase 2 clinical trial in Type 1 Diabetes and Kidney Disease (DKD). A grant from the United States National Institutes of Health (U.S. NIH) of $8.9 million has been awarded to Professor Victor Thannickal at the University of Alabama at Birmingham (UAB) to fund a multi-year research program evaluating the role of NOX enzymes in idiopathic pulmonary fibrosis (IPF), a chronic lung disease that results in fibrosis of the lungs; the core component of the program will be to conduct a Phase 2 trial with the GKT831 in patients with IPF. This product candidate may also be active in other fibrotic indications. Genkyotex’s second product candidate, GKT771, is a NOX1 inhibitor targeting multiple pathways in angiogenesis, pain processing, and inflammation, currently undergoing preclinical testing.

Genkyotex also has a versatile platform well-suited to the development of various immunotherapies (Vaxiclase). A partnership has been established with Serum Institute of India Private Ltd (Serum Institute) and could generate approximately €150 million in future revenues for Genkyotex, before royalties on sales.

For further information, please go to www.genkyotex.com.

Disclaimer

This press release may contain forward-looking statements by the company with respect to its objectives. Such statements are based upon the current beliefs, estimates and expectations of Genkyotex’s management and are subject to risks and uncertainties such as the company's ability to implement its chosen strategy, customer market trends, changes in technologies and in the company's competitive environment, changes in regulations, clinical or industrial risks and all risks linked to the company's growth. These factors as well as other risks and uncertainties may prevent the company from achieving the objectives outlined in the press release and actual results may differ from those set forth in the forward-looking statements, due to various factors. Without being exhaustive, such factors include uncertainties involved in the development of Genkyotex’s products, which may not succeed, or in the delivery of Genkyotex’s products marketing authorizations by the relevant regulatory authorities and, in general, any factor that could affects Genkyotex’s capacity to commercialize the products it develops. No guarantee is given on forward-looking statements which are subject to a number of risks, notably those described in the registration document (document de reference) registered by the French Markets Authority (the AMF) on 27 April 2018 under number R.18-037, and those linked to changes in economic conditions, the financial markets, or the markets on which Genkyotex is present. Genkyotex products are currently used for clinical trials only and are not otherwise available for distribution or sale.

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