Business Wire

Pharnext Reports Financial Results for Year-End 2017

Del

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

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Koza Altin Welcomes Court’s Rejection of Akin Ipek’s Share Purchase Agreement13.7.2018 15:58Pressemelding

A Turkish Court has found against businessman Akin Ipek this week – ruling that a share purchase agreement, which he had submitted as vital evidence in support of his case against the Turkish state, is null and void. The matter was brought to the Ankara Commercial Court in March 2017 by Koza Holding (parent company of Koza Altin) which, according to Mr Ipek’s share purchase agreement, purportedly transferred all of its shares to Ipek Investment Limited. Koza Holding filed the lawsuit for legal recognition that the share purchase agreement is void. The ruling in Turkey follows on from an earlier judgment set down by the English High Court, which rejected Mr Ipek’s attempt to use up to £3m of UK subsidiary Koza Ltd’s money to fund a claim against the Turkish State at the International Centre for Settlement of Investment Disputes (ICSID). In the English ruling, Deputy Judge Richard Spearman QC declared the “authenticity” of the share purchase agreement as “open to very serious doubt”. The

Mindbreeze Positioned in the Leaders Quadrant of the Gartner’s 2018 Magic Quadrant for Insight Engines13.7.2018 15:27Pressemelding

Mindbreeze, a leading global provider of appliances and cloud services for information insight and applied artificial intelligence with a focus on knowledge management for leading international companies, announced today that Gartner, Inc. has positioned Mindbreeze in the Leaders quadrant of the 2018 Magic Quadrant for Insight Engines. Mindbreeze is positioned highest on the ability to execute axis. The research and advisory firm Gartner, Inc. evaluated 13 different providers from all over the world. “Understanding the meaning of information is a key priority for today’s customers. Mindbreeze InSpire leverages the full power of our sophisticated AI engine to provide actionable insights and answers ̶ not just more data. Seeing our position in the Magic Quadrant, my first reaction was ‘AWESOME’. Insight Engine was positioned the highest on the ability to execute axis and we believe that's exactly what sets us apart from our competitors. We made the bold move to focus on product innovatio

H.I.G. Capital Announces the Sale of Kondor13.7.2018 14:06Pressemelding

H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €20 billion of equity capital under management, announced today that one of its affiliates has sold Kondor Limited, a specialist provider of category management solutions for audio and mobile accessory products into the retail and mobile network channels in the UK and Europe, to DCC Technology (which principally trades under the Exertis brand), part of DCC plc, the leading international sales, marketing and support services group. Terms of the transaction were not disclosed. Headquartered in Dorset, England, Kondor distributes audio and mobile accessory products to a broad range of e-tail, retail and mobile operator customers. H.I.G. invested in Kondor in 2014, and has since overseen a full reorganisation of the business. H.I.G. worked in partnership with Kondor to professionalise back office systems, develop Kondor’s access to market data, optimise the company’s product range, improve stock manag

Contactless Technology Powers Fifty Percent of Purchases at 2018 FIFA World Cup Russia™13.7.2018 09:00Pressemelding

Visa (NYSE: V), the Official Payment Services Partner of FIFA, today released an analysis of spending inside the 2018 FIFA World Cup Russia™ stadiums from the opening match on June 14 through the semi-finals on July 11. The data highlights the increased consumer adoption of innovative payment technology, as fifty percent of purchases with Visa in tournament venues utilized contactless transactions, including cards, mobile devices and wearables. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180713005025/en/ For the 2018 FIFA World Cup Russia™, Visa is the exclusive payment service in all stadiums where payment cards are accepted. In-stadium, fans can pay with contactless Visa credit and debit cards and mobile payment services at the more than 3,500 point-of-sale terminals and 1,000 mobile concessionaires that have been equipped with the latest in payment innovation. (Photo: Business Wire) Visa cardholders on average spent 1,

Brazil Approves AerSafe for Airbus 321 Aircraft to Comply with Fuel Tank Flammability Reduction Rule12.7.2018 19:18Pressemelding

AerSale ® announced today that the National Civil Aviation Agency of Brazil (ANAC) has approved the Federal Aviation Administration’s (FAA’s) Supplemental Type Certificate (STC) for the company’s AerSafe™ system on Airbus 321 aircraft (ST04010NY), that complies with the Fuel Tank Flammability Reduction (FTFR) rule. This is the second ANAC STC approval for AerSafe, following approval on Boeing 737 CL aircraft in 2017. In the coming months, AerSafe will be expanded to cover additional aircraft types, to meet the September 2019 deadline of the ANAC regulation, Regulamento Brasileiro da Avaiação Civil (RBAC) nº 121.1117, that applies specifically to passenger aircraft that fly within or into Brazil. AerSale’s STCs for the Boeing 737 CL and NG series (ST02980NY) and Boeing 767 series (ST03599NY) have already been approved by the FAA. “We are pleased that our Latin American customers operating A320 family aircraft are now able to immediately benefit from AerSafe’s numerous advantages,” said

Blockchain-based Adents NovaTrack Issues Token to Standardize Access to Comprehensive Supply Chain Traceability12.7.2018 18:20Pressemelding

Adents, leading serialization and track & trace solutions provider, announces the issue of tokens that, combined with its NovaTrack platform, will standardize access to full supply chain traceability. Adents recently released Adents NovaTrack, a marriage of technologies co-developed with Microsoft. The solution utilizes Blockchain, A.I., IoT and serialization functionalities that, when combined, bring comprehensive visibility throughout product distribution chains & life cycles. The result is a solution highly mindful not only in terms of performance and security, but also governance and scalability. With NovaTrack, Adents aims to create an ecosystem of consortium-based blockchains independent from each other, and individually launched on-demand by various supply chain stakeholders (brands, manufacturers, logistics professionals, etc.). Each consortium-based blockchain will provide a secure environment to its participants to share supply chain data and processes. From brands, manufactu