Genkyotex Provides Business Update and Reports Cash Position at March 31, 2021
13 Maggio 2021 - 7:13PM
Business Wire
- Cash and cash equivalents of €3.8 million as of March 31,
2021
- Rights issue of €5 million in March 2021 completed
- Positive data from Phase 1 clinical trial of high-dose
setanaxib
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 €3.8 million as of March 31, 2021. The existing cash
and cash equivalents provide cash runway to end of July 2021.
Business update
On March 24, 2021, the Company announced that it had raised €5
million through a rights issue in France. Following this capital
increase, the Company's main shareholder, Calliditas Therapeutics
AB (publ), holds 90.2% of the share capital and voting rights of
the Company.
Clinical highlights
- Phase 1 study with setanaxib at high doses: in January
2021, the Company reported positive interim data from its Phase 1
clinical trial to evaluate the safety and pharmacokinetics of
setanaxib at dosages up to 1,600 mg/day in healthy subjects.
- Development strategy for setanaxib in primary biliary
cholangitis (PBC): Genkyotex continues to plan the initiation
of a pivotal Phase 2/3 study in primary biliary cholangitis (PBC),
during the second half of 2021, with final design and protocol
details subject to feedback from the US Food and Drug
Administration (FDA). The launch of the study is subject to the
availability of adequate financial resources.
- Phase 2 proof-of-concept study in patients with head and
neck cancer: the Company announced, on January 22, 2021, that
it plans to initiate before the end of this year a Phase 2
proof-of-concept study in patients with head and neck cancer. The
launch of the study is subject to the availability of adequate
financial resources. The trial will evaluate administration of
setanaxib, targeting cancer associated fibroblasts (CAFs), in
conjunction with immunotherapy.
- The Company continues to support two investigator-initiated
Phase 2 studies with setanaxib, respectively, in Type 1
Diabetes and Kidney Disease (DKD) (study financed by the Juvenile
Diabetes Research Foundation of Australia and the Baker Institute
for which 34 patients have completed the full 48-week treatment
with no safety signals identified) and in idiopathic pulmonary
fibrosis (IPF) (study financed by the NIH led by Professor Victor
Thannickal of the University of Alabama at Birmingham evaluating
the safety and efficacy of setanaxib dosed at 800 mg/day (400 mg
BID) over a period of 24 weeks).
Q1 2021 Financial
highlights
On March 31, 2021, the Company’s cash and cash equivalents
totaled €3.8 million vs. €1.2 million on December 31, 2020, and
included the net proceeds of €5.05m from the rights issue completed
on March 24. The Company’s cash burn in Q1 2021 was primarily
driven by R&D expenses related to chemistry, manufacturing and
control (CMC) activities and the Phase 1 trial to investigate
higher dose with setanaxib.
The Company expects its current resources to support anticipated
operations until the end of July 2021, taking into account the
facts and assumptions detailed in note 2.1 “Going concern” of the
December 31, 2020 consolidated financial statements. Calliditas has
confirmed its intention, so long as the Company remains its
controlled subsidiary, to continue supporting the Company, if need
be, so as 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. Calliditas has also advised
the Company that the ability of Calliditas to provide funding for
Genkyotex further developments could be adversely affected if there
is a delay in launching Calliditas’ planned squeeze-out offer
(offre de retrait) and related delisting of the Company from the
regulated markets of Euronext Paris and Euronext Brussels because,
as long as Genkyotex remains a listed company, an effective
integration of its research and development and clinical
development activities with those of Calliditas is made more
difficult and the financing of Genkyotex will require the
completion of costly and time consuming rights offerings. Failure
to obtain the necessary financing could lead the Company to
interrupt or reduce its envisioned research and development and
clinical development activities.
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, the COVID-19 pandemic 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.
Next financial events & press releases: Annual
General Meeting: May 27, 2021 Q2 2021 financial update: August 19,
2021 Half Year Results 2021: September 30, 2021 Q3 2021 financial
update: October 21, 2021
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 are supported by
the Company 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