- Positive data from Phase 1 clinical trial of high-dose
setanaxib
- Cash and cash equivalents of €1.2 million as of December 31,
2020
- Calliditas Therapeutics AB (publ) tender offer closed in
December 2020, resulting in an ownership percentage of
86.24%
Regulatory News:
Genkyotex (Euronext Paris & Brussels: FR0013399474 –
GKTX) (Paris:GKTX) (Brussels:GKTX), a biopharmaceutical company
and the leader in NOX therapies, today reported cash and cash
equivalents of €1.2 million as of December 31, 2020. The existing
cash and cash equivalents provide cash runway to the end of
February 2021. After this date Genkyotex will be required to fund
the ongoing operations with new capital. Calliditas Therapeutics,
the majority shareholder of Genkyotex, has expressed its intent to
participate in such future financings on a pro rata basis. Until
such financing has occurred, Calliditas will support Genkyotex by
way of debt financing to enable the Company to meet its liabilities
as they fall due and to carry on its normal business without any
significant curtailment of operations.
Business update
On August 13, 2020, the Company announced the agreement by
Calliditas to acquire 7,236,515 ordinary shares of Genkyotex,
representing 62.7% of the share capital and voting rights from the
Company’s largest shareholders and management team.
On December 17, 2020, the Company announced the results of the
tender offer, according to the results published on December 16,
2020 by the Autorité des marchés financiers (AMF), a total of
2,885,161 shares were tendered to the public offering. Following
the close of the public offer, Calliditas held 10,121,676 shares of
the Company representing 86.24% of the share capital and voting
rights of the Company.
Clinical highlights
- Phase 1 trial with setanaxib at higher doses: in January
2021, the Company reported positive data from its Phase 1 clinical
trial to evaluate the safety and pharmacokinetics of setanaxib at
dosages up to 1,600 mg/day.
- Development strategy for setanaxib in primary biliary
cholangitis (PBC): based on the Phase 1 trial data and
interactions with US and European regulators in 2020, the Company
recently announced that it plans to launch a pivotal and
potentially registrational Phase 2/3 trial of setanaxib in patients
with primary biliary cholangitis (PBC) in the second half of 2021.
The final design and protocol details are subject to feedback from
the US Food and Drug Administration (FDA).
- Phase 2 proof-of-concept study in patients with head and
neck cancer: the Company recently announced that it plans to
initiate a Phase 2 proof-of-concept study in patients with head and
neck cancer before the end of the year. The trial will evaluate
administration of setanaxib, targeting cancer associated
fibroblasts (CAFs), in conjunction with immunotherapy.
- Orphan drug designation (ODD) for setanaxib in primary
biliary cholangitis (PBC): setanaxib was granted orphan drug
designation for the treatment of primary biliary cholangitis (PBC)
by the US Food and Drug Administration (FDA) in October and by the
European Commission in December, following the positive opinion
from the Committee for Orphan Medicinal Products (COMP) of the
European Medicines Agency (EMA).
- Phase 2 trial of setanaxib in idiopathic pulmonary fibrosis
(IPF): the Company announced on September 14, 2020, the
enrollment of the 1st patient in a Phase 2 trial of setanaxib in
IPF. This study is conducted in accordance with a protocol approved
by the U.S. Food and Drug Administration (FDA) and the relevant
Institutional review board (IRB). 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 team 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 Company’s Phase 2 trial with setanaxib in
PBC, the DKD trial protocol was amended to increase the dose to 400
mg BID. To date, 29 patients have 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, but investigators cannot
exclude a possible slowdown in new patient enrollment in the
study.
Q4 2020 Financial
highlights
On December 31, 2020, the Company’s cash and cash equivalents
totaled €1.2 million vs. €3.6 million on September 30, 2020. The
Company’s cash burn over the FY 2020 was primarily driven by
R&D expenses related to the preparation of the End-Of-Phase 2
meeting with the FDA and the Phase 1 study to investigate higher
dose with setanaxib.
The Company 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 and the
condensed consolidated interim financial statements prepared in
accordance with IFRS for the six-month period ended June 30, 2020.
Genkyotex will be required to fund the ongoing operations with new
capital. Calliditas Therapeutics, the majority shareholder of
Genkyotex, has expressed its intent to participate in such future
financings on a pro rata basis. Until such financing has occurred,
Calliditas will support Genkyotex by way of debt financing.
Financial results to September 30,
2020
As part of the accounting consolidation process of Calliditas,
the Company prepared consolidated financial statements for the
nine-month period ended September 30, 2020 under IFRS, as issued by
the International Accounting Standards Board.
These financial statements are available in the Investors
section of the Company’s website. The Company does not plan
going-forward to report on standalone nine-month financial
information or on quarterly financial information (other than in
relation to its quarterly cash and cash equivalents position).
In thousands of euros
Nine-month period ended
September 30, 2020
At December 31, 2019
Other Income
35
142
Research & Development expenses
(9,627)
(6,305)
Subsidies and Research Tax Credit
356
899
General & Administrative expenses
(1,757)
(2,160)
Operating loss
(10,993)
(7,425)
Net loss
(11,017)
(7,203)
Net loss per share (in euros)
(0.99)
(0.88)
Given its stage of development, the Company has not generated
any sales to date, as all of its product candidates are in the
Research & Development (R&D) phase.
The consolidated net loss as at September 30, 2020 is €11,017
thousand against €7,203 thousand as at December 31, 2019. This
increase is mainly driven by the impairment of the SIIL contract as
a consequence of the impact of Covid-19 on the development
timelines (negative impact of €5.8 M), partially offset by the
reduction of R&D costs due to the end of the Phase 2 clinical
trial with setanaxib in primary biliary cholangitis (PBC) and
reduced G&A costs.
Governance
Following the closing of the off-market block trade on November
3, 2020, the members of the board of directors other than Elias
Papatheodorou, Chief Executive Officer, resigned. Elmar Schnee,
Chairman of the board of Calliditas, Renée Aguiar-Lucander, Chief
Executive Officer of Calliditas and Jonathan Schur, Group General
Counsel of Calliditas, have been appointed as members of the Board
of directors. Elmar Schnee has been elected President of the Board
of directors. Dr. Philippe Wiesel, Executive Vice President and
Chief Medical Officer of Genkyotex, has left the Company to pursue
new professional projects. He will remain as a consultant to
Calliditas.
COVID-19 update
In the context of the COVID-19 pandemic, the Company continues
to closely monitor the evolution of the official 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.
To date, except for the impairment of the SIIL contract (see
above), the COVID-19 pandemic has had a limited impact on the
Company’s operations. Genkyotex will continue to monitor the impact
of the COVID-19 pandemics on the conducting of clinical trials and
discussions with health authorities and, depending on the evolution
of the pandemics and of its potentially material impact on such
trials and discussions, will keep the market informed.
About Genkyotex
Genkyotex is the leading biopharmaceutical company in NOX
therapies, listed on the Euronext Paris and Euronext Brussels
markets. Its leading 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).
Clinical trials in PBC and head and neck cancer with setanaxib are
being planned in 2021 and investigator led studies in Type 1
Diabetes and Kidney Disease (DKD) and in idiopathic pulmonary
fibrosis (IPF), a chronic lung disease that results in fibrosis of
the lungs, are ongoing.
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