- Cash and cash equivalents of €5.6 million as of March 31, 2020
- Limited impact of COVID-19 pandemic on the Company's operations to date
- No anticipated delay to the end-of-phase-2 meeting with the FDA
- Launch of Phase 2 IPF trial still expected in 2020 despite the COVID-19 situation
Regulatory News:
Genkyotex (Euronext Paris Brussels: FR0013399474 GKTX), a biopharmaceutical company and the leader in NOX therapies, today reported cash and cash equivalents of €5.6 million as of March 31, 2020. This amount does not include the French research tax credit of €0.9 million which was received by the Company in April 2020. The existing cash and cash equivalents provide cash runway to end of February 2021.
COVID-19 update
In the context of the COVID-19 pandemic, the Company is following applicable guidelines and recommendations in order to protect its employees and contractors. The Company has also implemented strategies to mitigate the impact of the global shutdown on its business and operations.
The Company has asked its employees in France and Switzerland to work from home and to organize meetings and events virtually as much as possible.
To date, the Company is only anticipating a limited impact on its operations, including the planned discussions with regulatory authorities, the conducting of clinical trials as well as interactions with the scientific community and other stakeholders. The Company will continue to monitor the possible impact of COVID-19 on the conducting of clinical trials and discussions with health authorities and, depending on the evolution of the pandemics and of its material impact on such trials and discussions, will report to the markets on any such material impact.
The Company has made progress in its key activities, in particular the end-of-phase-2 discussions with regulators with a view to a phase 3 study in Primary biliary cholangitis (PBC), and the conducting of the phase 1 study with setanaxib as described in the clinical highlights section below. The launch of the phase 2 trial in IPF is still expected in 2020 and could occur in the first semester despite the COVID-19 situation.
Clinical highlights
- End-of-phase-2 discussions with regulators for PBC: an end-of-phase-2 meeting with the US Food and Drug Administration (FDA) is planned in April, as previously indicated. In line with FDA's remote work guidelines, the meeting will take place via conference call. The Company also plans to submit its final briefing document to the European Medicine Agency (EMA) in Q2 2020, as expected.
- IPF phase 2 trial: as previously reported, the U.S. Food and Drug Administration (FDA) and the relevant Institutional Review Board (IRB) have approved the protocol of the Phase 2 IPF trial, allowing the initiation of patient enrollment. The launch of the study is still expected in 2020 and could occur in the first semester despite the COVID-19 situation. This trial is fully funded by an $8.9 million grant awarded by the U.S. National Institutes of Health (NIH). The study is being led by Professor Victor Thannickal at the University of Alabama at Birmingham and includes a consortium of five investigational centers of excellence in the United States. The study will evaluate the safety and efficacy of setanaxib in 60 IPF patients receiving standard of care therapy (pirfenidone or nintedanib). Enrolled patients will be treated with setanaxib or a matching placebo for 24 weeks. Efficacy endpoints include changes in plasma o,o'-dityrosine, a biomarker based on the mechanism of action of setanaxib, as well as standard clinical outcomes that include the 6-minute walk test and forced vital capacity (FVC). Plasma levels of collagen fragments will also be assessed. The safety and tolerability of setanaxib will also be evaluated. The trial size, design, and endpoints are adequate to support the initiation of a phase 3 program should there be a positive outcome.
- DKD phase 2 trial: following the positive efficacy and safety results of the Company's Phase 2 trial of setanaxib in primary biliary cholangitis (PBC), the DKD trial protocol was amended to increase the dose to 400 mg BID. To date, 23 patients have already completed the full 48-week treatment and no safety signals have been identified. The DKD trial is being conducted primarily in Australia, with work ongoing to activate centers in New Zealand, Denmark, and Germany. In the context of COVID-19 pandemic, investigators have taken steps to minimize patient visits to investigation centers, in accordance with applicable rules and recommendations. Adequate drug supplies have been made available to the participating centers and patients. Despite the relatively low rate of SARS-Cov-2 infection in Australia, investigators cannot exclude a possible slowdown in new patient enrollment in the study.
- Phase 1 study with setanaxib at high doses: the Company plans to conduct an additional phase 1 study to investigate the pharmacokinetics, potential for drug interactions, and safety profile of setanaxib at doses up to 1,600mg. The study protocol was submitted to local and national regulators and the study is still expected to start in H1 2020.
Financial highlights
On March 31, 2020, Genkyotex's cash and cash equivalents totaled €5.6 million vs. €2.4 million on December 31, 2019. This includes the €4.9 million rights issue completed in February 2020, but does not include the French research tax credit of €0.9 million which was received by the Company in April. Despite the COVID-19 situation, the Company still expects its current resources to support anticipated operations until the end of February 2021, taking into account the facts and assumptions detailed in note 2.1 "going concern" of the December 31, 2019 consolidated financial statements. The Company will continue to inform the market of the possible impacts of COVID-19 on its operations.
Shareholders' meeting
In order to protect the health and safety of its employees and shareholders, and in accordance with the measures adopted by the French Government, in particular pursuant to Ordonnance No. 2020-321 of March 25, 2020, the Company has decided to hold its combined shareholders' meeting expected to occur on June 10, 2020, without shareholders and other persons eligible to attend being present (behind closed doors).
In this context, any shareholder, whatever the number of shares he owns, has the right to vote at the general meeting in two ways: either by voting by post, or by giving a proxy to the Chairman of the general meeting.
Shareholders are also entitled to ask written questions prior to the meeting.
The technical terms allowing shareholders to exercise all of these rights will be detailed on the Company's website, as well as in the notice of meeting to be published by the Company in the BALO (Bulletin des annonces légales obligatoires) prior to the shareholders' meeting planned on June 10, 2020.
Next financial press release:
Q2 2020 business update and cash position: July 23, 2020 (after market)
About Genkyotex
Genkyotex is the leading biopharmaceutical company in NOX therapies, listed on the Euronext Paris and Euronext Brussels markets. Its unique platform enables the identification of orally available small-molecules which selectively inhibit specific NOX enzymes that amplify multiple disease processes such as fibrosis, inflammation, pain processing, cancer development, and neurodegeneration. Genkyotex is developing a pipeline of first-in-class product candidates targeting one or multiple NOX enzymes. The lead product candidate, setanaxib (GKT831), a NOX1 and NOX4 inhibitor has shown evidence of anti-fibrotic activity in a Phase II clinical trial in primary biliary cholangitis (PBC, a fibrotic orphan disease). Based on its positive Phase II results, a phase 3 trial with setanaxib in PBC is being planned. Setanaxib is also being evaluated in an investigator-initiated Phase II clinical trial in Type 1 Diabetes and Kidney Disease (DKD). A grant from the United States National Institutes of Health (NIH) of $8.9 million was 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 this program is a Phase 2 trial with setanaxib in patients with IPF scheduled to recruit patients in the course of 2020. This product candidate may also be active in other fibrotic indications.
Genkyotex also has a versatile platform well-suited to the development of various immunotherapies (Vaxiclase). A partnership covering the use of Vaxiclase as an antigen per se (GTL003) has been established with Serum Institute of India Private Ltd (Serum Institute), the world's largest producer of vaccine doses, for the development by Serum Institute of cellular multivalent combination vaccines against a variety of infectious diseases.
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 universal registration document filed with the AMF on January 16, 2020 under number 20-0012, 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
View source version on businesswire.com: https://www.businesswire.com/news/home/20200423005674/en/
Contacts:
GENKYOTEX
Alexandre Grassin
CFO
Tel.: +33 (0)5 61 28 70 60
investors@genkyotex.com
NewCap
Dušan Orešanský
Tel.: +33 1 44 71 94 92
genkyotex@newcap.eu
