DJ Pharnext announces 2020 half-year results
Pharnext
Pharnext announces 2020 half-year results
15-Oct-2020 / 08:30 CET/CEST
Dissemination of a French Regulatory News, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.
Pharnext announces 2020 half-year results
PARIS, France, 08:30 a.m. CET, October 15, 2020 - Pharnext SA (FR0011191287 - ALPHA),
an advanced clinical-stage biopharmaceutical company pioneering a new approach to
developing innovative drug combinations based on big genomic data and artificial
intelligence, announced today its financial results for first-half 2020.
KEY EVENTS FIRST-HALF 2020
On our lead program with PXT3003
In March 2020, the MHRA (UK) granted PIM designation to PXT3003 for the treatment of
CMT1A in patients of 16 years and older. A PIM designation is an early indication that
a medicinal product is a promising candidate for the Early Access to Medicines Scheme
("EAMS") in the treatment, diagnosis or prevention of life-threatening or seriously
debilitating conditions with unmet need.
Based on our most recent interactions, the FDA has provided guidance on the path to the
approval of PXT3003 and has agreed with the key elements of our proposed approach for
the developmental pathway to approval for PXT3003. Specifically, the FDA has indicated
that a single pivotal Phase III Study in CMT1A delivering positive results, together
with positive results from a preclinical factorial design study to demonstrate the
contribution of each component of PXT3003, could be sufficient to submit a dossier for
approval of PXT3003, depending on the robustness of the trial results.
On corporate governance
On April 16, 2020, Pharnext announced the appointment of Mr. David Horn Solomon as
Pharnext C.E.O
As part of the 2020 Annual General Meeting, the Company proposed transformation of the
board consistent with the Company's vision of developing and commercializing PXT3003 in
the US and Europe for CMT1A. The newly appointed directors have strong
biopharmaceutical and business expertise focused on clinical development, neurology,
strategy, transactions, value creation and governance experience. The newly appointed
directors are: Alexandre Berda, Dr. Jean Combalbert, Joshua Schafer, Dr. David Solomon
(also CEO of Pharnext), Pr. Lawrence Steinman, Dr. Elisabeth Svanberg.
On cash-in operation
Two significant financial transactions that took place in the first half of the year
2020 with:
· on March 10, 2020, Pharnext completed an ABSA private placement for gross proceeds
of &euro 7.7 million by issuing 1,799,061 new shares. To each of these shares is
attached a share warrant;
· share warrants exercise by Kepler-Cheuvreux took place from March 31 to May 18,
2020. These exercises translated to the issuance of 2,155,000 new shares for a gross
product of just over &euro 8 million.
As of June 30, 2020, the company has collected the full Research Tax Credit (CIR) of
2019, i.e. &euro 3,165,026.
FINANCIAL INFORMATION SUMMARY
Main financial elements are presented in the table below: these are from financial
statements established according to IFRS rules and were approved by the Board of
Directors at their meeting held on October 14, 2020. Reviews were carried out and the
reports from the statutory auditors are being edited.
Complete financial statements are available on the Pharnext website: www.pharnext.com
[1].
Summary of financial information (IFRS) end of 2020 2019
June (K&euro)
Revenue from operations 40 213
Other Income 1 179 1 777
Administrative and commercial expenses -3 578 -4 214
Research and Development expenses -5 481 -8 008
Operating result -7 840 -10 231
Financial result -1 253 - 2 056
Net income -9 093 -12 288
Cash flows generated from operating activities -5 423 -13 860
Cash generated from investment activities 2 -177
Cash generated from financing activities 12 846 15 986
Net cash flow 7 425 1 949
Cash and cash equivalents 23 671 24 710
The Company's operating income was up compared to the same period of 2019 primarily due
to lower Research and Development expenses during the period by approximately 2,527
K&euro compared to the same period in 2019. Other Income decreased due to a lower
research tax credit which was also due to a lower level of clinical expenses and some
expenditures which no longer meet the eligibility conditions.
Timing of the phases of clinical studies explained the decrease of R&D expenses to
subcontracted and specialized companies.
The increase of Net Cash Flow is primarily due to lower overall Operating Expenses
driven by lower R&D expenses compared to the same period in 2019, in combination with
the financing activity during the first half of 2020, including a &euro7.7 million
private placement of common stock as well as approximately &euro8 million issued
through our equity line.
The net loss for the period stands at -9,093 k&euro, compared to -12,287 k&euro for the
same period of 2019.
About Pharnext
Pharnext is an advanced clinical-stage biopharmaceutical company developing novel
therapeutics for orphan and common neurodegenerative diseases that currently lack
curative and/or disease-modifying treatments. Pharnext has two lead products in
clinical development. PXT3003 completed an international Phase III trial with positive
topline results 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
encouraging Phase II results in Alzheimer's disease. Pharnext has developed a new drug
discovery paradigm based on big genomics data and artificial intelligence:
PLEOTHERAPY. Pharnext identifies and develops synergic combinations of drugs called
PLEODRUG. The Company was founded by renowned scientists and entrepreneurs
including Professor Daniel Cohen, a pioneer in modern genomics, and is supported by a
world-class scientific team. More information at www.pharnext.com [1].
Pharnext is listed on the Euronext Growth Stock Exchange in Paris (ISIN code:
FR0011191287).
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 the estimates
contained in such forward-looking statements will be verified, which estimates are
subject to numerous risks including the risks set forth in Pharnext's document de base
filed with the AMF on June 2, 2016 under number I.016-0050 as well as in its annual
periodic management reports and press releases (copies of which are available on
www.pharnext.com) 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.
Pharnext disclaims any intention or obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future events, or
otherwise.
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.
Contacts
David Horn Solomon
Chief Executive Officer
contact@pharnext.com
+33 (0)1 41 09 22 30
Media Relations Media Relations (U.S.) Media Relations (France)
(International)
Rooney Partners LLC Ulysse Communication
Consilium Strategic
Communications
Jeffrey Freedman Bruno Arabian
Mary-Jane Elliott
jfreedman@rooneyco.com +33 (0)6 87 88 47 26
Sukaina Virji
+1 646 432 0191 barabian
[2]@ulysse-communication.com
Alexandra Harrison
Pierre-Louis Germain
pharnext@consilium-comms.com
+33 (0)6 64 79 97 51
plgermain@ulysse-communication.com
+33 (0)1 81 70 96 30
Investors Relations (U.S.) Financial
Communication (Europe)
Stern Investor Relations,
Inc. Actifin
Janhavi Mohite Stéphane Ruiz
janhavi.mohite@sternir.com sruiz@actifin.fr
+1 212 362 1200 +33 (0)1 56 88 11 15
Regulatory filing PDF file
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1141003 15-Oct-2020 CET/CEST
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(END) Dow Jones Newswires
October 15, 2020 02:30 ET (06:30 GMT)
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