Genkyotex Provides Business Update and Reports Cash Position at September 30, 2020
22 Outubro 2020 - 1:30PM
Business Wire
- Cash and cash equivalents of €3.6 million as of September
30, 2020
- Setanaxib granted ODD by the US FDA in PBC in
October
- 1st patient enrolled in the Phase 2 trial in IPF in
September
- Phase 1 study with high-dose setanaxib on track with results
expected by the end of Q4 2020
- Discussions with the US and European health authorities on
the registration strategy for setanaxib in PBC are ongoing
- Ongoing transaction with Calliditas Therapeutics
Regulatory News:
Genkyotex (Euronext Paris & Brussels: FR0013399474 –
GKTX), a biopharmaceutical company and the leader in NOX
therapies, today reported cash and cash equivalents of €3.6 million
as of September 30, 2020. The existing cash and cash equivalents
provide cash runway to the end of February 2021.
Business update and
outlook
The Company announced on August 13, 2020 an agreement for
Calliditas Therapeutics AB to acquire a 62.7% controlling interest
in Genkyotex SA from Genkyotex's largest shareholders and
management team. The off-market block trade is expected to take
place in the coming weeks and remains subject to customary
conditions precedent, including clearance from the French Ministry
of Economy and Finance regarding foreign investments in French
companies. Calliditas is seeking to acquire all outstanding
Genkyotex shares and, as soon as reasonably practicable after and
subject to completion of the off-market block trade, will file with
the French Financial Market Authority (Autorité des Marchés
Financiers or “AMF”) a mandatory simplified cash tender offer for
the remaining Genkyotex shares on the same terms as the block trade
(€2.80 per share in cash and contingent rights to additional cash
payments subject to confirmation of regulatory approvals or
marketing authorization of setanaxib no later than within ten years
of the closing of the tender offer).
Clinical highlights
- Registration strategy for setanaxib in primary biliary
cholangitis (PBC): in October 2020, setanaxib was granted
orphan drug designation (ODD) by the US Food and Drug
Administration (FDA). The company is currently discussing its
registration strategy for setanaxib in PBC with the FDA and the
EMA. Genkyotex will provide an outline of its late stage
development plan once final approval of a common registration
strategy has been obtained from these regulatory agencies.
- Phase 2 trial of setanaxib in idiopathic pulmonary
fibrosis: the company announced on September 14, 2020 the
enrollment of the 1st patient in a Phase 2 trial of setanaxib in
IPF. This investigator-initiated study is being led by Professor
Victor Thannickal of the University of Alabama at Birmingham and
includes a consortium of five research centers of excellence in the
United States. It is fully funded by an $8.9 million grant awarded
to Professor Thannickal’s teams by the U.S. National Institutes of
Health (NIH). The aim of the study is to evaluate the safety and
efficacy of setanaxib dosed at 800 mg/day (400 mg BID) in 60 IPF
patients receiving standard treatment (pirfenidone or nintedanib)
over a period of 24 weeks.
- Phase 2 trial of setanaxib in diabetic kidney disease
(DKD): following the positive efficacy and safety results of
the Company’s Phase 2 trial of setanaxib in PBC, the DKD trial
protocol was amended to increase the dose to 400 mg BID. To date,
29 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 the
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
has initiated an additional Phase 1 study to investigate the
pharmacokinetics, safety profile, and potential for drug
interactions of setanaxib at doses up to 1,600 mg. The study is on
track and results are expected by the end of Q4 2020.
Financial highlights
On September 30, 2020, Genkyotex's cash and cash equivalents
totaled €3.6 million vs. €5.1 million on June 30, 2020. The Company
still expects its current resources to support anticipated
operations until the end of February 2021, on a standalone basis
and 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.
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 suffering from IPF for which the first
patient has been enrolled in September 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 April 30,
2020 under number D.20-0434, 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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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