- Current cash reach to end of February
2021
- Company has no outstanding financial debt
as all outstanding convertible bonds were converted in early
2020
- Phase 2 study with setanaxib in IPF
expected to start in the coming weeks
Regulatory News:
Genkyotex (Paris:GKTX) (Brussels:GKTX) (Euronext Paris &
Brussels: FR0011790542 – GKTX), a biopharmaceutical company and the
leader in NOX therapies, announces its consolidated financial
results for the year ended December 31, 20191, in accordance with
International Financial Reporting Standards (IFRS), as adopted by
the European Union. A summary of the consolidated financial
statements is included below.
Elias Papatheodorou, CEO of Genkyotex, says: “2019 was a
pivotal year that saw our company reach several milestones in the
advanced clinical development of setanaxib. From a clinical
perspective, the results of our phase 2 study with setanaxib in
primary biliary cholangitis demonstrated the ability of our
compound to significantly reduce liver stiffness and improve
patients’ quality of life, while being well tolerated. These
important findings make us confident about setanaxib potential in
multiple fibrotic diseases. We are looking forward to our
end-of-Phase 2 meeting with the FDA in which we would like to
obtain an agreement on the design of the Phase 3 study.
Simultaneously, setanaxib is evaluated in two other Phase 2
studies, one in diabetic kidney disease associated with type 1
diabetes (DKD) currently underway, and the other in idiopathic
pulmonary fibrosis (IPF) that should start in the coming weeks.
Both studies are funded by grants provided to our academic
partners. In this context, the amount of €4.9 million raised in
February 2020 with the support of our long-standing shareholders
extends our financial visibility until the end of February 2021 and
allows us to focus on the development of setanaxib in our targeted
fibrotic indications and explore its potential in other therapeutic
areas with high unmet needs.”
On December 31, 2019, Genkyotex had cash and cash equivalents of
€2.4 million which does not include the €4.9 million raised in
February 2020. The Company expects that its current cash position
is sufficient to fund planned operations to the end of February
2021.
- Given its stage of development, Genkyotex has not generated any
sales to date, as all of its product candidates are in the Research
& Development (R&D) phase. The subsidies received
correspond to the expected French research tax credit for 2019
(€899 thousand).
- R&D expenses are mainly related to the costs of the Phase 2
clinical trial of setanaxib in primary biliary cholangitis (PBC).
The study was completed in May 2019, driving the annual costs down
compared to 2018. As previously communicated, the Phase 2 clinical
trial in Diabetic Kidney Disease, initiated by investigators, is
being financed by the Juvenile Diabetes Research Foundation (JDRF
Australia) and the Baker Institute.
- Genkyotex recorded a consolidated net loss of -€7.2 million for
the year ended December 31, 2019 compared to a net loss of -€11.4
million at December 31, 2018.
1 Consolidated accounts were approved by
the Board on February 24, 2020. The auditors have completed their
procedures on the consolidated financial statements. They will
continue with the post-balance sheet event review until issuance of
their audit report.
Selected 2019 financial
results
€ thousands - IFRS
At December 31, 2019
At December 31, 2018
Income from customers agreement
-
750(b)
Research & Development expenses(a)
(6,305)
(9,282)
Subsidies and Research Tax Credit
899
893
General & Administrative expenses
(2,160)
(2,836)
Other Income
142
44
Current operating loss
(7,425)
(10,430)
Other operating expenses
-
-
Operating loss
(7,425)
(10,430)
Net loss for the period
(7,203)
(11,417)
Net loss per share (in euros)(a)
(0.88)
(1.46)
(a) The net loss per share as at December
31, 2018 has been adjusted to reflect the effect of the 10-for-1
reverse stock split of Genkyotex’s common shares which became
effective March 29, 2019.
(b) In 2018, the Company received €750
thousand corresponding to the upfront payment resulting from the
execution of the Serum of India Institute Private Ltd (SIIPL)
licensing agreement extension announced on June 25, 2018. In
accordance with the terms of this agreement, which provides for
milestone payments based on development and sales, no payments have
been received in 2019.
The consolidated statement of financial position and the
consolidated income statement prepared in accordance with IFRS, as
adopted by the European Union, for the year ended December 31, 2019
are included in appendix 1 of this press release.
2019 key highlights and outlook for
2020
- Positive effect on liver stiffness in
the PBC phase 2 trial with setanaxib: In May 2019, the
Company reported top-line results of its PBC phase 2 trial with
setanaxib. In this trial, setanaxib achieved clinically meaningful
reductions in liver stiffness, and statistically significant
reductions in gamma glutamyl transpeptidase (GGT) (p<0.002) and
alkaline phosphatase (ALP) (p<0.001) over the 24-week treatment
period, but did not achieve statistical significance in the
reduction of GGT at week 24, the predefined primary efficacy
endpoint. A post-hoc analysis reported in July 2019 showed that
statistical significance of p=0.02 was achieved for the primary
endpoint for 400mg BID at week 24 when correcting for the
non-normal distribution in the 400mg OD group. Moreover, Setanaxib
400mg BID achieved a substantial reduction (-22%) in liver
stiffness in patients with advanced disease (≥9.6 kPa at baseline).
In these patients, setanaxib also achieved clinically meaningful
reductions in GGT (-32%) and ALP (-24%) at week 24. Importantly,
setanaxib 400mg BID also achieved a statistically significant
improvement in quality of life, and was well tolerated at all
doses. Collectively, these data indicate that setanaxib could
become a new therapeutic option for the difficult to treat patient
populations with advanced liver fibrosis in PBC and other liver
diseases, including advanced NASH. Based on these positive results,
a phase 3 trial in PBC is being planned. The Company will be
discussing with regulators to finalize the design of its phase 3
trial with setanaxib in primary biliary cholangitis (PBC) and plans
to enroll patients with inadequate response to UDCA standard of
care therapies, including the emerging population of patients
receiving generically available PPAR agonists (e.g. bezafibrate).
This is in contrast with other phase 3 programs which exclude these
patients. The Company expects its phase 3 to include measurements
of liver stiffness and quality of life, which remains an
unaddressed medical need. An end-of-Phase 2 meeting with the FDA is
scheduled and an agreement on the phase 3 design with the US Food
and Drug Administration (FDA) is envisioned in the first half of
2020.
- IPF phase 2 trial with setanaxib to be initiated in the
following weeks: The 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 first site
initiation is anticipated shortly, with patient enrollment expected
to start in the coming weeks. The trial size, design, and endpoints
have been defined to adequately support the initiation of a phase 3
program in case of positive phase 2 outcomes. This trial is 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 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 which include the 6-minute walk distance and forced vital
capacity (FVC). The safety and tolerability of setanaxib will be
also evaluated.
- Extension of the Phase 2 DKD trial with setanaxib in New
Zealand, Denmark and Germany: The principal investigators
leading the diabetic kidney disease (DKD) trial decided, with
agreement from Genkyotex, to expand the investigational network by
adding centers in Germany, Denmark and New Zealand. Ethical
committees have approved the study protocol in New Zealand and
three sites are pending activation. Germany and Denmark will
follow. Considering 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. As of today, 13
patients have already completed the full 48-week treatment and no
safety concerns have been reported.
- WHO recognized NOX enzymes as new therapeutic class: The
Company announced in July 2019 that the World Health Organization
(WHO) recognized NOX inhibitors as a new therapeutic class, while
approving the new stem “naxib”. The WHO recommended setanaxib as
the international non-proprietary name (INN, or generic name) for
GKT831.
- New oncology grant: The Company announced in February
2019 that its academic partner, Professor Gareth Thomas of the
University of Southampton (UK), was awarded a Biotherapeutics Drug
Discovery Project grant by Cancer Research UK (CRUK), a leading
cancer research and awareness organization based in the UK, to
conduct a research program focused on the role of NOX inhibition in
oncology. The £260 thousand grant will support the research program
entitled "Combination immunotherapy for breast cancer: targeting
cancer-associated fibroblasts to improving therapeutic
vaccination.” This is the second grant provided by CRUK to
Professor Thomas for the evaluation of NOX inhibitors in
oncology.
Next financial press release: Q1 2020 business update and
cash position: April 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 first semester 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.
Appendix 1 – Statement of consolidated financial position and
consolidated income statement as of December 31, 2019
The statement of consolidated financial position and
consolidated income statement of Genkyotex S.A. were prepared in
accordance International Financial Reporting Standards (IFRS), as
adopted by the European Union. The auditors have completed their
procedures on the consolidated financial statements. They will
continue with the post-balance sheet event review until issuance of
their audit report. The consolidated financial statements for the
period ended December 31, 2019 were approved by Board of Directors
on February 24, 2020 and will be submitted to the shareholders at
the Shareholders’ Meeting planned on June 10, 2020.
GENKYOTEX
12/31/2019
12/31/2018
Consolidated Income
Statement
12 months
12 months
(in thousands of EUR)
Sales
-
-
Cost of sales
-
-
Gross margin
-
-
Income from customers
agreement
-
750
Research and development
expenses
Research and development
expenses
(6.305)
(9.282)
Subsidies
899
893
General and administrative
expenses
(2.160)
(2.836)
Other income
142
44
Current operating loss
(7.425)
(10.430)
Other operating income
-
-
Other operating expenses
-
-
Operating loss
(7.425)
(10.430)
Financial income
(190)
(1.185)
Financial expenses
412
197
Pre-tax loss
(7.203)
(11.417)
Income tax (expense)
-
-
Net loss for the
period
(7.203)
(11.417)
Attributable to owners of the
parent company
(7.203)
(11.417)
Non-controlling interests
-
-
12/31/2019
12/31/2018
Basic loss per share
(EUR/share) (1)
(0,88)
(1,46)
Diluted loss per share
(EUR/share) (1)
(0,88)
(1,46)
(1) The loss per share in 2018 has been
adjusted to reflect the effect of the 10-for-1 reverse stock split
of Genkyotex’s common shares, as approved by Genkyotex shareholders
at the Extraordinary General Meeting on January 24, 2019 and
implemented by the Board of Directors the same day.
GENKYOTEX
12/31/2019
12/31/2018
Consolidated Statement of
Financial Position
(in thousands of EUR)
ASSETS
Intangible assets
9.086
10.221
Property, plant and equipment
154
51
Non-current financial assets
29
64
Total non-current
assets
9.270
10.336
Other current assets
1.500
1.932
Current financial assets
-
3.280
Cash and cash equivalents
2.417
11.345
Total current assets
3.917
16.557
Total Assets
13.186
26.893
LIABILITIES AND EQUITY
Equity
Capital
8.683
7.785
Additional paid-in capital
126.118
162.015
Cumulative translation
adjustments
(2.732)
(2.258)
Accumulated other comprehensive
loss
(697)
(316)
Accumulated deficit attributable
to owners of the parent
(114.332)
(117.917)
Net loss attributable to owners
of the parent
(7.203)
(25.773)
Equity attributable to owners
of the parent
9.836
23.535
Non-controlling interests
-
-
Total equity
9.836
23.535
Non-current
liabilities
Employee benefit obligations
1.348
822
Non-current financial
liabilities
17
115
Non-current
liabilities
1.364
937
Current liabilities
Current financial liabilities
848
288
Financial derivative
64
Trade payables
562
1.312
Other current liabilities
512
820
Current liabilities
1.986
2.421
Total Liabilities and
Equity
13.186
26.893
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version on businesswire.com: https://www.businesswire.com/news/home/20200227005762/en/
GENKYOTEX Alexandre Grassin CFO +33 (0)5 61 28 70 60
investors@genkyotex.com
NewCap Dušan Orešanský +33 1 44 71 94 92
genkyotex@newcap.eu