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

Experience the Tour de France live with Mytyres.co.uk and Continental25.4.2018 19:05Tiedote

Steeped in tradition, the world’s most famous cycling race is soon to kick off for the 105th time. Customers of Mytyres.co.uk now have the unique opportunity to travel to Paris and watch as the teams cross the finishing line in one of the world’s most popular sporting events. In cooperation with premium manufacturer Continental, the online shop is giving away 15 places on a trip to the final stage of the Tour de France on the Champs-Élysées on 29th July 2018. Travel, accommodation, and transport is included for all participants. Participation is very easy. Simply buy at least 2 Continental summer tyres via Mytyres.co.uk before 6th May 2018, complete the registration form on the order confirmation page, and cross your fingers! The Continental tyre range available to customers on Mytyres.co.uk includes all current summer models. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180425006242/en/ Experience the Tour de France live

Al Kasir Group Launches Diamond Trading on Blockchain25.4.2018 19:01Tiedote

Members of the Private Office of H.H. Sheikh Ahmad Bin Obaid Al Maktoum L.L.C., AL KASIR JEWELLERY TRADING L.L.C. and AL KASIR PORTAL L.L.C. announced the launch of Diamond Trading on Blockchain with three Diamond-backed Blockchain-Assets. These Assets are stored in highly secure Digital Blockchain Wallets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180425006234/en/ Dr. Amit Lakhanpal, Founder and CEO of Money Trade Coin Group and Mohammed Al Jariri, Director of Companies, Private office of His Highness Sheikh Ahmed Bin Obaid Al Maktoum along with other dignitaries (Photo: AETOSWire) The launch event, held April 15, 2018 at Burj Al Arab, was witnessed by the managements of the Private Office and Al Kasir Group. The guests included Shehab Bin Nouri, Walid Bin Nouri and Mohammed Aljariri. India's leading economist Dr Sharad Koli and 40 other VIPs. Over 140 members of the Press from across the globe were also present. Al Ka

Panasonic Is Exhibiting Latest Connected Supply Chain Solutions for Industry 4.0 Realization at CeMAT 2018 Trade Fair in Germany25.4.2018 18:50Tiedote

Panasonic Corporation is exhibiting its full range of logistics solutions at CeMAT 2018, the world's leading trade fair for the intralogistics and supply chain management sector, which is being held from April 23-27 in Hannover, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180425006197/en/ The Panasonic booth at CeMAT 2018 (Photo: Business Wire) [Video] Highlights of Panasonic at #CeMAT Supply Chain Solutions - Gemba Process Innovation https://youtu.be/oQq2EEjNSAs At its booth (Hall 20 / Stand C73), Panasonic is using live demonstrations and video displays to introduce its full line of solutions which maximize operational efficiency at each step of the supply chain from labeling and dispatch error detection at factories, to sorting and loading at distribution centers, on to transportation and proof of delivery. A video display at the front of the booth illustrates the flow of logistics information and material tra

Smithers Viscient Europe Appoints Jane Gray as Senior Manager, Terrestrial Ecotoxicology25.4.2018 18:42Tiedote

Smithers Viscient, a global contract research organization (CRO), today announced the appointment of Jane Gray to the position of Senior Manager, Terrestrial Ecotoxicology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180425006181/en/ Jane Gray, Senior Manager, Terrestrial Ecotoxicology at Smithers Viscient (Photo: Business Wire) Gray joins Smithers as a highly experienced Terrestrial Ecotoxicologist with over 17 years of CRO experience. Gray will oversee the management of a multidisciplinary team and lead the introduction of new study types as well as the design and conduct of guideline and non-standard studies to meet specific sponsor and regulatory objectives. “We are very excited to have Jane join our team as we continue to expand the Terrestrial team and grow our business in Harrogate. Jane’s experience and skill set in non-target arthropods; non-target plant studies and a range of pollinator studies will be an invalu

Munich Re: VitalityLife wins prestigious 2018 Celent Model Insurer Award for Operational Excellence25.4.2018 16:00Tiedote

Munich Re Automation Solutions Ltd. has announced that its long-established client, VitalityLife, has been recognized in Celent’s 2018 Model Insurer awards for its exemplary work in re-writing the rules of underwriting to achieve operational excellence. VitalityLife was rewarded for its novel use of technology in its Vitality Nurse initiative, reducing the time needed to fix underwriting terms for a life cover application from an average of 14 working days to as little as two hours. This initiative deploys a new team of Vitality nurses, equipped with the powerful third party data processor ALLFINANZ Evidence Analyzer from Munich Re. The nurse visits the client at home, carries out the blood test and enters their medical screening results directly into the ALLFINANZ Evidence Analyzer on their iPad, producing an immediate underwriting result. “We’re well known for our innovative products which are rooted in a culture of creativity and a desire to do what’s best for society” said Deepak J

EURid Announces the 2018 .eu Web Awards Launch25.4.2018 15:52Tiedote

The .eu Web Awards is an online competition, designed to acknowledge the best websites, using the .eu or .ею extensions, in five diverse categories. Anyone, who is eligible according to the .eu Web Awards rules can nominate their favourite .eu or .ею. website. This includes .eu and .ею domain name holders themselves, who can nominate their very own website for participation in the .eu Web Awards. “Our goal with the .eu Web Awards is to enhance the visibility of innovative, beautiful, and impactful .eu and .ею websites”, commented Giovanni Seppia, EURid External Relations Manager. The 15 finalists will be invited to the .eu Web Awards gala, held in Brussels on 21 November 2018, where the 5 winners – one per category - will be announced. The winners will receive a prestigious award package, including a two-month billboard advertising campaign in Brussels Airport, a custom 1-minute video produced by EURid for their promotional purposes, a custom trophy and personalised certificate. The 20

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