- Two strategic partnerships completed
validating the platform and the pipeline
- Major investment by Tasly
Pharmaceutical
- Target confirmed: first marketing
authorization of PXT3003 in the second half of 2019
Regulatory News:
Pharnext SA (FR00111911287 - ALPHA), a
biopharmaceutical company pioneering a new approach to the
development of innovative drugs based on the combination and
repositioning of known drugs, today announced its first-half 2017
financial results.
Daniel Cohen, M.D., Ph.D. Co-Founder and CEO said of
activity for the first half of 2017: "Activity in the first-half of
the year was very dense; we implemented two prominent strategic
partnerships with the biotech company Galapagos and the Tasly
Group, one of the top ten pharmaceutical companies in China. Our
flagship product, PXT3003 for the treatment of Charcot-Marie-Tooth
disease type 1A, is nearing the end of Phase 3, which is slated for
the second half of 2018. We confirm our target of taking the
product to market by 2019."
A half-year marked by strategic agreements
In March 2017, Pharnext signed its first R&D partnership
with Galapagos NV for the creation of a new pipeline of
pre-clinical combinations. This agreement relies on Pharnext's drug
research and development platform: PLEOTHERAPY™. The working
programme involves several therapeutic indications particularly in
inflammatory diseases.
In May 2017, Pharnext also signed a major strategic agreement
with Tasly Pharmaceutical, a group in the top 10 of listed Chinese
pharmaceutical companies. This agreement is for a €20 million
investment by Tasly in Pharnext and the creation of a Joint-Venture
(JV) for research and development, 30% owned by Pharnext, to
develop new combinations between chemical molecules and drugs
produced by modernised Chinese traditional medicine. This
partnership also includes a licensing agreement for the JV to
market the drug candidate PXT3003 for CMT1A on the Chinese
market.
Continuation of the clinical trial for PXT3003 in
Charcot-Marie-Tooth disease type 1A (CMT1A) with a first date set
year-end 2017
During the first half of 2017, Pharnext continued the Phase 3
clinical trial of PXT3003, PLEODRUGTM candidate, for the treatment
of CMT1A. Patient enrolment was completed in compliance with the
established roadmap.
An important step is expected by the end of 2017 with the
results of the adaptive design and futility analysis.
The aim of the adaptive design analysis is to determine whether
or not more patients should be added to the study. The futility
analysis helps determine whether to continue or discontinue the
trial, based on the observed efficacy of the first patient sample
(100/300).
High visibility at large international events
Along with ongoing R&D efforts, there was an increased
presence at major international scientific meetings dedicated to
orphan and neurodegenerative diseases, and to the repositioning of
drugs:
- In late March 2017, Pharnext presented
new synergy data in Vienna, Austria, at the 13th International
Conference on Alzheimer's and Parkinson's diseases and related
neurological disorders. In pre-clinical models of Alzheimer's
disease, PXT864 enhanced the efficacy of standard therapeutic
treatments.
- In late June 2017, the R&D
PLEOTHERAPY™ platform was presented during the 6th Annual
Conference on "Drug Repositioning, Repurposing and Rescue" in
Chicago, United States. This presentation also gave Pharnext the
opportunity to provide more specific information on its business
model and growth strategy for the coming years.
- In early July 2017 in Sitjes, Spain, a
status update of the pivotal Phase 3 clinical trial for PXT3003 in
CMT1A was presented during an oral presentation and on a poster at
the 2017 Peripheral Nerve Society Meeting.
- In mid-July 2017 in London, United
Kingdom, new synergy data on PXT864 in Alzheimer's disease were
also presented at the Alzheimer's Association International
Conference 2017.
- In early September 2017, a status
update of the pivotal Phase 3 trial of PXT3003 was also presented
as a poster at the 2017 American Association of Neuromuscular &
Electrodiagnostic Medicine (AANEM) in Phoenix, United States.
From now until the end of the year, Pharnext will participate in
major international events where it will have the opportunity to
spotlight the clinical development of PXT3003 and PXT864 to the
global medical and scientific community. For instance, the company
will give a presentation at the CMT Patient Summit of the
Hereditary Neuropathy Foundation (HNF). This will be held in
Boston, United States, on 3 November. The company will also take
part in the CTAD (Clinical Trial on Alzheimer's Disease) conference
in Boston, United States, from 1-4 November.
H1 2017 Financial Results
as €K (1) – IFRS at 30 June H1 2017 H1 2016 Other
income
1,216 1,993 Research & development expenses
(7,610) (5,740) Administrative costs
(2,936) (1,927)
Operating income
(9,330) (5,674) Financial income
(767) (2,295) Net income
(10,098)
(7,969) Net cash flows generated from (used in) operating
activities
(12,108) (3,692) Net cash generated
from (used in) investment activities
(152)
(296) Net cash generated from (used in) financing activities
1,740 5,907 Change in cash and cash equivalents
(10,521) 1,919 Cash and cash equivalents
6,149 5,008
Pro forma cash after Tasly investments
26,149
(1) The H1 2017 financial statements were approved by the Board
of Directors at their meeting on 19 October 2017. They were subject
to a limited review by the Statutory Auditors. The half-year
financial report is available on the Company's website:
https://www.pharnext.com/en/investors/
As the company is not yet seeing any revenue, most other
deferred revenue comes from the research tax credit (Research Tax
Credit for H1 2017 of €K 1,956, and the French Tax Credit for
Competitiveness and Employment (CICE) to the amount of €K
10.2).
The increase in R&D spending is related to the development
of Phase 3 trials with PXT3003 on Charcot-Marie-Tooth disease (CMT
1A).
The operating loss at 30 June 2017 was -€9.3 million, compared
to -€5.6 million one year earlier. Our financial expenses decreased
by € 1.5 million as a result of the conversion of bonds during the
IPO. After accounting for these elements, net income came to -€10.1
million compared with -€7.9 million at 30 June 2016.
Cash flow requirements generated by the activity amounted to
€12.1 million in the first half of 2017. Cash flow from investments
came to -€K 152. Resources generated by financing activities stood
at €1.7 million.
On 30 June 2017, the company's share capital was negative at
-€6.4 million. Cash assets amounted to €6.1 million before
Tasly operations.
Post-closing, the agreements signed with Tasly Pharmaceuticals
had several financial impacts in July, with the income from a
restricted capital increase, a €5 million cash contribution
(€4.9 million issue premium) and a €15 million convertible
bond issuance.
Restated for these two transactions, pro forma cash assets at
the end of June 2017 after the Tasly Group's investment, amount to
€26.1 million.
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 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. PXT864 has generated
positive Phase 2 results in Alzheimer's disease. Pharnext is the
pioneer of a new drug discovery paradigm: PLEOTHERAPY™. The company
identifies and develops synergistic combinations of repositioned
drugs at optimal reduced doses. These PLEODRUG™ have many
significant benefits: effective and innocuous, their solid
intellectual property includes several product patents already
delivered. The Company is supported by a world-class scientific
team.
The company Pharnext is listed on Euronext Growth Stock Exchange
in Paris (ISIN code: FR00111911287).
For more information, visit our website: www.pharnext.com
UPCOMING EVENTS
Salon Actionaria, Paris: 23 & 24
November 2017
Publication of 2017 annual results: 27
April 2018
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 registration document filed with the Autorité
des marchés financiers (AMF- French Financial Market Authority) on
July 28, 2016 under n°R.16-069 and to the development of 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20171019006257/en/
Financial Communications (France and
Europe)ActifinStéphane Ruiz, +33 (0)1 56 88 11
11sruiz@actifin.frorInvestor Relations (U.S.)Stern Investor
Relations, Inc.Matthew Shinseki, +1
212-362-1200matthew@sternir.com
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