Regulatory News:
Pharnext SA (Paris:ALPHA) (FR00111911287 – ALPHA), a
French biopharmaceutical company pioneering a new approach to
developing innovative drug combinations based on Big Data genomics
and Artificial Intelligence, today reported its financial and
operational results for the year ended December 31, 2017.
2017 KEY EVENTS
During 2017, Pharnext continued its international Phase 3 trial
of PXT3003 for the treatment of Charcot-Marie-Tooth type 1A (CMT1A)
disease. This pivotal 15-month trial is being conducted at 29 sites
including 17 in Europe, 11 in the U.S. and one in Canada.
In September 2017, the independent Data Safety Monitoring Board
(DSMB) completed its second pre-specified safety evaluation of
PXT3003. Based on a review of safety data from all randomized
patients, the DSMB recommended Pharnext continue the study as
planned.
In November 2017, two additional interim analyses were
conducted. These consisted of a blind variability analysis followed
by a futility analysis. The results indicated that the PLEO-CMT
study could continue according to the original plan, without having
to increase the trial size.
In March 2017, Pharnext initiated an open-label extension study,
which includes patients that completed the double-blind PLEO-CMT
study. All patients received one of two doses of PXT3003 over an
additional nine-month period. The initial results from this
extension study are expected in the second quarter of 2019.
In May 2017, Pharnext signed a strategic agreement with Tasly
Pharmaceutical (Shanghai: 600535), an organization ranked amongst
China’s top 10 pharmaceutical companies. This partnership included
three components: a financial investment by Tasly in Pharnext
comprised of €5 million in shares and €15 million in
convertible bonds; the development of a new pipeline of synergistic
combinations through a joint-venture; and the license of Pharnext’s
lead product PXT3003 to the joint-venture for commercialization in
the Chinese market.
In March 2017, Pharnext signed a research and development
(R&D) agreement with biotechnology company Galapagos NV
(NASDAQ: GLPG). The primary aim of this agreement is to generate a
pipeline of novel synergistic drug combinations in a broad set of
indications.
SELECTED FINANCIAL INFORMATION
The main elements of the year-end 2017 financials are set out in
the table below: These are taken from the financial statements
drawn up under IFRS, which were approved by the Board of Directors
at its meeting on April 12, 2017. The audit procedures have been
carried out and the auditors’ report relating to the certification
of the accounts is in the process of being issued. The full
financial statements are available on the Company’s website:
www.pharnext.com.
Selected financial information (under IFRS) In
thousands of euros
2017 2016 Operating
revenues 3,324 4,436 Research and development
expenses (15,529) (13,647) SG&A expenses (5,949) (4,177)
Operating income (18,153) (13,389)
Financial income (1,922) (4,058) Net
income (20,075) (17,447) Basic earnings per share
(in €) (2) (2.1)
Net cash flows used in operating
activities (18,800) (12,553) Net cash flows
used in financing activities 15,361 26,902 Net
cash movement -4,215 13,581 Cash and cash
equivalents at the end of the period 12,454
16,670
Operating revenues for 2017 were mainly generated by the
Company’s research tax credit (€3.9m in 2017) and subsidies.
The increase in research and development expenses were directly
linked to the ramp-up of the PXT3003 Phase 3 clinical trial.
Financial income for 2017 was impacted by the recognition under
financial expenses of the convertible bond issue in July for
Tasly.
Net cash flows used in operating activities totalled €18.8m in
2017. The increase compared to the previous period was primarily
the result of the Phase 3 roll-out.
Net cash flows used in financing activities in 2017 primarily
comprised the €5m capital increase and the issue of €15m in
convertible bonds for Tasly. In 2017, loan repayments and payment
of interest charges and transaction costs on borrowing totalled
€5.2m.
ANTICIPATED UPCOMING MILESTONES
Pharnext will announce the results from PLEO-CMT, the Phase 3
clinical trial for its drug candidate PXT3003 in CMT1A, during the
second half of 2018.
Beyond the 15-month PLEO-CMT study, patients will continue
treatment in a 9-month follow-up extension study designed to assess
the long-term safety of PXT3003. This follow-up extension study,
which began in March 2017, will continue throughout the year. The
initial results are expected in the second quarter of 2019.
Pharnext is planning to launch a Phase 2b pediatric clinical
trial for PXT3003 in CMT1A in Europe and the United States.
In addition, after obtaining promising preliminary results in
the Phase 2a trial for PXT864 in Alzheimer's disease and data in
other neurodegenerative diseases, the Company has identified two
additional strategic priorities for 2018:
- Prioritize and identify new orphan
indications to launch internal Phase 2a studies;
- Continue to develop strategic
collaborations in common indications.
ABOUT PHARNEXT
Pharnext is an advanced clinical-stage biopharmaceutical company
founded by renowned scientists and entrepreneurs including
Professor Daniel Cohen, a pioneer in modern genomics: Pharnext has
two lead products in clinical development: PXT3003 is currently in
an international Phase 3 trial for the treatment of
Charcot-Marie-Tooth disease type 1A and benefits from orphan drug
status in Europe and the United States. The results of this trial
are expected before the end of 2018. PXT864 has generated positive
Phase 2 results in Alzheimer’s disease. Pharnext is the pioneer of
a new drug discovery paradigm based on Big Data genomics and
Artificial Intelligence: PLEOTHERAPY™. The Company identifies and
develops synergistic combinations of drugs. These PLEODRUG™ offer
several key advantages: efficacy, safety and protected intellectual
property. The Company is supported by a world-class scientific
team.
Pharnext is listed on Euronext Alternext Stock Exchange in Paris
(ISIN code: FR00111911287).
For more information, visit www.pharnext.com
DISCLAIMER
This press release contains certain forward-looking statements
concerning Pharnext and its business. Such forward-looking
statements are based on assumptions that Pharnext considers to be
reasonable. However, there can be no assurance that such
forward-looking statements will be verified, which statements are
subject to numerous risks, including the risks set forth in the
Document de référence filed with the Autorité des Marchés
Financiers (AMF- French Financial Market Authority) on July 28,
2016 under no. R.16-069 and to changes in economic conditions,
financial markets and the markets in which Pharnext operates. The
forward-looking statements contained in this press release are also
subject to risks not yet known to Pharnext or not currently
considered material by Pharnext. The occurrence of all or part of
such risks could cause actual results, financial conditions,
performance or achievements of Pharnext to be materially different
from such forward-looking statements.
This press release and the information that it contains do not
constitute an offer to sell or subscribe for, or a solicitation of
an offer to purchase or subscribe for, Pharnext shares in any
country. The communication of this press release in certain
countries may constitute a violation of local laws and regulations.
Any recipient of this press release must inform oneself of any such
local restrictions and comply therewith.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180412006388/en/
PharnextAmit Kohli, +33 (0)1 41 09 22 30Chief Operating
Officerinvestors@pharnext.comorInvestor Relations (Europe)MC
Services AGAnne Hennecke, +49 211 529252
22anne.hennecke@mc-services.euorInvestor Relations
(U.S.)Stern Investor Relations, Inc.Matthew Shinseki, +1
212-362-1200matthew@sternir.comorFinancial
Communication (France)ActifinStéphane Ruiz, +33 (0)1 56 88 11
15sruiz@actifin.frorMedia Relations (Europe)ALIZE RPCaroline
Carmagnol, +33 (0)1 44 54 36 66pharnext@alizerp.comorMedia
Relations (U.S.)RooneyPartnersKate Barrette,
+1-212-223-0561kbarrette@rooneyco.com
Pharnext (EU:ALPHA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pharnext (EU:ALPHA)
Historical Stock Chart
From Apr 2023 to Apr 2024