Genkyotex Provides Business Update for Q1 2017
27 April 2017 - 06:46PM
Business Wire
Cash & cash equivalents of €21.8 million
as of March 31, 2017
Regulatory News:
Genkyotex (Euronext Paris & Brussels: FR00011790542 – GKTX),
a biopharmaceutical company and the leader in NOX therapies, today
provided a corporate update and announced its cash & cash
equivalents and liquid investments position for the first quarter
ended March 31, 2017.
Business highlights
- On February 28, 2017, the shareholders
of Genticel approved the resolutions implementing the strategic
combination between Genticel and GenKyoTex, pursuant to the
contribution agreement signed on December 22, 2016 between Genticel
and GenKyoTex’ shareholders, as well as the change of the Company’s
name from “Genticel” to “Genkyotex” as from February 28, 2017. The
shareholders also approved the appointments of:
- Claudio Nessi, Ilias (Elias)
Papatheodorou, Eclosion 2 & Cie SCPC, Edmond de Rothschild
Investment Partners, Catherine Moukheibir, and Mary Tanner as board
members; and
- Stéphane Verdood and Joseph McCracken
as board observers.
- On the same day, the board of directors
of the Company appointed Claudio Nessi as Chairman of the Board,
and Elias Papatheodorou as Chief Executive Office of the combined
Company.
Clinical highlights
The Company is on track with the preparation for the initiation
of its Phase 2 trial with GKT831 in primary biliary cholangitis
(PBC). The trial is expected to begin by the end of the first half
of 2017.
In addition, Genkyotex is pursuing the development of its second
clinical candidate, GKT771, through ongoing IND enabling studies,
and intends to initiate a Phase 1 clinical trial by the end of
2017, as planned.
Research highlights
Genkyotex also continues to explore the therapeutic value of NOX
inhibition in oncology, hearing loss and Parkinson’s disease. The
Company seeks opportunities of non-dilutive grant financing to
support the preclinical evaluation of drug candidates in these
areas.
Financial highlights
As of March 31, 2017, Genkyotex's cash & cash equivalents
was €21.8 million (vs. €26.7 million on December 31, 2016), in line
with the Company's expectations. The cash position does not include
the expected reimbursement of Research Tax Credit (Crédit Impôt
Recherche) for 2016, which the company has estimated to be at about
€3.0 million.
About Genkyotex
Genkyotex is the leading biopharmaceutical company in NOX
therapies. Listed on the Euronext Paris and Euronext Brussels
markets, Genkyotex is established in France and, via its GenKyoTex
Suisse SA subsidiary, in Switzerland. A leader in NOX therapies,
its unique therapeutic approach is based on a selective inhibition
of NOX enzymes that amplify multiple disease processes such as
fibrosis, inflammation, pain processing, cancer development, and
neurodegeneration.
Genkyotex’s platform enables the identification of orally
available small-molecules that selectively inhibit specific NOX
enzymes. Genkyotex is developing a pipeline of first-in-class
product candidates targeting one or multiple NOX enzymes. The lead
product candidate, GKT831, a NOX1 and NOX4 inhibitor is expected to
enter a phase II clinical trial in primary biliary cholangitis
(PBC, a fibrotic orphan disease) during the first half of 2017.
This product candidate may also be active in other fibrotic
indications. Its second product candidate, GKT771, is a NOX1
inhibitor targeting multiple pathways in angiogenesis, pain
processing, and inflammation, and should enter a phase I clinical
study during the second half of 2017.
Genkyotex also has a versatile platform, Vaxiclase, that is
particularly well-suited to the development of various
immunotherapies. A partnership covering the use of Vaxiclase as an
antigen per se (GTL003) has been established with Serum Institute
of India Ltd (Serum Institute), the world’s largest producer of
vaccine doses. This agreement covers territories outside the United
States and Europe, and could generate up to $57 million in revenues
for Genkyotex, before royalties on sales. It will enable Serum
Institute to develop acellular multivalent combination vaccines
against a variety of infectious diseases, including whooping cough.
The last preclinical milestone foreseen in the agreement was
reached in November 2016, opening the path to formal preclinical
testing prior to potential clinical development and subsequent
commercialization.
For further information, please go to
www.genkyotex.com
Disclaimer
This press release and the information it contains does not
constitute an offer or solicitation to buy, sell or hold Genkyotex
shares in any country, in particular any jurisdiction in which such
offer, solicitation or sale would be unlawful prior to
registration, exemption from registration or other qualification
under the securities laws of any such jurisdiction.
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
registration document filed with the French Markets Authority (the
AMF) on 1 April 2015 under number R.15-015, as updated in the
Document E filed with the AMF on 31 January 2017 under number
E.17-004, 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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