Business Wire

Pharnext Reports Financial Results for Year-End 2017

Jaa

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.

Contact information

Pharnext
Amit Kohli, +33 (0)1 41 09 22 30
Chief Operating Officer
investors@pharnext.com
or
Investor Relations (Europe)
MC Services AG
Anne Hennecke, +49 211 529252 22
anne.hennecke@mc-services.eu
or
Investor Relations (U.S.)
Stern Investor Relations, Inc.
Matthew Shinseki, +1 212-362-1200
matthew@sternir.com
or
Financial Communication (France)
Actifin
Stéphane Ruiz, +33 (0)1 56 88 11 15
sruiz@actifin.fr
or
Media Relations (Europe)
ALIZE RP
Caroline Carmagnol, +33 (0)1 44 54 36 66
pharnext@alizerp.com
or
Media Relations (U.S.)
RooneyPartners
Kate Barrette, +1-212-223-0561
kbarrette@rooneyco.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

First Westinghouse AP1000® Nuclear Plant Sanmen 1 Completes Initial Criticality21.6.2018 23:24Tiedote

Westinghouse Electric Company, China State Nuclear Power Technology Corporation (SNPTC) announced today that the world’s first AP1000 nuclear power plant located in Sanmen, Zhejiang Province, China has successfully completed initial criticality. “Today we completed the final major milestone before commercial operation for Westinghouse’s AP1000 nuclear power plant technology,” said José Emeterio Gutiérrez, Westinghouse president and chief executive officer. “We are one step closer to delivering the world’s first AP1000 plant to our customer and the world – with our customers, we will provide our customers in China with safe, reliable and clean energy from Sanmen 1.” Following initial criticality will be connection to the electrical grid. Once plant operations begin at Sanmen 1, it will be the first AP1000 nuclear power plant in operation, offering innovative passive safety system technology, multiple layers of defense and advanced controls for unequaled reliability and safety. Commentin

Westinghouse Loads Fuel in Second AP1000® Nuclear Power Plant21.6.2018 23:07Tiedote

Westinghouse Electric Company and its customers, China State Nuclear Power Technology Corporation (SNPTC) and Shangdong Nuclear Power Company Limited (SDNPC) announced today that Haiyang Unit 1, the AP1000 nuclear power plant located in Haiyang, Shandong Province, China, has begun to load fuel. “This is a great day for Westinghouse, our China partners and the nuclear industry. Haiyang Unit 1 continues to demonstrate our ability to deliver safe, innovative solutions for power generation,” said José Emeterio Gutiérrez, Westinghouse president and chief executive officer. He added, “Westinghouse will continue to deploy AP1000 technology throughout the world and demonstrate our technical leadership in the nuclear energy industry.” Fuel load at Haiyang Unit 1 commenced at 7:36 p.m. (GMT+8) today. Earlier this summer, in preparation for fuel load, Haiyang Unit 1 successfully completed the necessary testing and regulatory reviews conducted by China’s National Nuclear Safety Administration (NNS

Pharnext to Announce Top-Line Results from the Pivotal Phase 3 Trial of PXT3003 for the Treatment of Charcot-Marie-Tooth Type 1A Disease by October 201821.6.2018 21:23Tiedote

Regulatory News: Pharnext SA (Paris:ALPHA) (FR0011191287 - ALPHA), a biopharmaceutical company pioneering a new approach to the development of innovative drug combinations based on big data genomics and artificial intelligence, today announced an update from its ongoing Phase 3 clinical program (PLEO-CMT and PLEO-CMT-FU studies) evaluating PXT3003 for the treatment of Charcot-Marie-Tooth type 1A disease (CMT1A) in adults. Top-line results from the pivotal PLEO-CMT study are now expected by October 2018. Prof. Daniel Cohen, M.D., Ph.D., Pharnext’s Co-Founder and Chief Executive Officer said: “We are thrilled to bring this Phase 3 clinical trial to completion and we now expect to disclose top-line results by October of this year. Our PLEODRUG™ PXT3003 has already shown initial signals of efficacy in our Phase 2 trial in CMT1A. We are hopeful we can bring this much-needed therapy to patients suffering from this debilitating condition, as they currently have limited therapeutic options, mo

Philip Morris International Makes Call to Creative, Media and Communications Communities21.6.2018 21:13Tiedote

Philip Morris International Inc. (“PMI”) (NYSE: PM), today announced a bold call to action for the creative, media and communications communities to embrace its ongoing commitment to creating a smoke-free world. As part of this initiative, PMI will offer smoke-free alternatives wherever we can, including heated tobacco products and e-cigarettes, to current smokers in the industry who would otherwise continue to smoke. During a keynote at the PMI Science Lounge at The Cannes Festival of Creativity, SVP of Communications Marian Salzman said, “We are asking the creative community to join us in raising awareness of the potential of science, technology and innovation for those who smoke and the people around them.” The move is part of PMI’s vision to lead the charge towards greater innovation and technology in the tobacco industry, all of which is backed by science. Agencies interested in joining the movement can contact Marian Salzman at marian.salzman@pmi.com. “People who smoke deserve in

IBC2018 Announces Cyber Security Forum to Help Media Tackle Cyber Threats21.6.2018 19:30Tiedote

IBC2018, the world’s most influential media, entertainment and technology show, today announces a Cyber Security Forum to expand its position as the preeminent cyber security destination for broadcasters and media. The event will form part of the prestigious annual IBC show at the RAI in Amsterdam from Thursday 13 to Tuesday 18 September 2018, which last year attracted more than 57,000 attendees from 170 countries. The Cyber Security Forum is one-day, invitation-only event that will convene Chief Technology Officers, Chief Information Officers, Chief Information Security Officers and Chief Digital Officers within media and broadcasting for a conversation on the challenges and opportunities presented by cyber security for broadcasters. Attendees will discuss how to anticipate the next cyber threat, how to manage a breach and how to prepare for the future of cyber security. The Cyber Security Forum sits alongside the Telco & Media Innovation Forum and Leaders’ Forum as part of IBC’s Exec

Mensia Technologies Raises 1,3 Million Euro to Introduce Koala Neurofeedback as a Revolutionary Medical Device in Europe21.6.2018 19:23Tiedote

Mensia Technologies, french MedTech start up, leads the new booming category of Digital therapeutics with its revolutionary « at home « neurofeedback, to train the brain and cure neuropsy disorders without drugs. Co-founder INRIA-IT2, existing shareholders and now HARA, which are business angels experts in medical device category, joined this fund raise. BPI de Rennes is also part of this tour. Mensia Technologies, borned out of INRIA in 2012. The IT expert labs in Rennes are computing real time signaling softwares. The neurofeedback technique is non invasive, at home and without drugs. MENSIA KOALA treats ADHD, Attention Deficit Disorders with or without Hyperactivity, children and adolescents. This unique medical device is a therapeutic video game on an interactive tablet connected to the brain activity. Children learn to control their attention by exercising 3 times a week during 4 months of treatment. Visual feedback given during the game, allows the children to learn, control and

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme