Business Wire

Pharnext: First-Half 2017


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:

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.


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:


Salon Actionaria, Paris: 23 & 24 November 2017

Publication of 2017 annual results: 27 April 2018


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.

Contact information

Financial Communications (France and Europe)
Stéphane Ruiz, +33 (0)1 56 88 11 11
Investor Relations (U.S.)
Stern Investor Relations, Inc.
Matthew Shinseki, +1 212-362-1200

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

Seoul Semiconductor’s SunLike Series LEDs Win Product of the Year Award from Elektronik Magazine23.3.2018 21:28Tiedote

Seoul Semiconductor, a global innovator of LED products and technology, announced on March 23rd that its SunLike Series natural spectrum LED product won the Gold Award at the Elektronik Product of the Year 2018 Awards, hosted by Elektronik (, a leading German electronics publication. This press release features multimedia. View the full release here: Product of the Year Award from Elektronik Magazine (SunLike) (Photo: Business Wire) As a publication specializing in electrical and electronic components, “Elektronik” is a prestigious magazine with an illustrious history and the largest number of subscribers in Germany. Over the past 20 years, they have conducted annual surveys among their subscribers to find the “most creative and innovative products.” Based on these survey results, Elektronik selects the top product that with the most impact in its corresponding field, and confers the awards accordingl

Elliott Welcomes Imminent Bezeq Board Overhaul and New Era for Strong Independent Governance23.3.2018 19:05Tiedote

Elliott Advisors (UK) Limited (“Elliott”), which advises funds which collectively hold a significant economic interest in Bezeq The Israeli Telecommunication Corporation Ltd. (“Bezeq” or the “Company”), welcomes the proposed governance reforms announced by Bezeq last night. In its initial letter to Bezeq Interim Chairman David Granot, dated January 16, 2018, Elliott outlined the urgent need to address the Company’s serious corporate governance issues, and called for changes at the Board level that result in “the right mixture of expertise, independence and integrity for the future.” Elliott stated then, and reiterates now, its belief that “there is significant value to be unlocked if the right steps are taken to improve its corporate governance.” Bezeq has strong business fundamentals, an exemplary workforce, and great potential. Following yesterday’s announcement, Elliott highlights the changes that have occurred since January 16th. Taken together, these amount to a revolution in the

Clovis Oncology Initiates Early Access Program for Rucaparib as Treatment and as Maintenance Therapy in Recurrent Ovarian Cancer in Europe23.3.2018 15:52Tiedote

Clovis Oncology, Inc. (NASDAQ:CLVS) today announced the initiation of an early access program in Europe for rucaparib for treatment and as maintenance therapy in recurrent ovarian cancer. The program will be overseen and implemented by Caligor Coghlan, which specializes in early access to medicines. The program, to be known as the Rucaparib Access Program (RAP), will enable participation from certain countries in Europe, where permitted by applicable rules, procedures and regulatory authorities. The RAP protocol allows for rucaparib treatment of an individual patient with third-line or greater BRCA mutant epithelial, fallopian tube, or primary peritoneal ovarian cancer who has platinum-sensitive disease and is unable to tolerate further platinum-based chemotherapy or has platinum-resistant disease and needs treatment with single agent rucaparib. The RAP protocol will also provide access to rucaparib for maintenance therapy of an individual patient with recurrent epithelial ovarian, fal

CHMP Grants Positive Opinion for Clovis Oncology’s Rubraca® (rucaparib) Tablets23.3.2018 15:50Tiedote

Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a conditional marketing authorization for Rubraca as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy. The European Marketing Authorization application for the treatment indication was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA mutant ovarian cancer who had progressed after two or more prior chemotherapies. “The recommendation

Janssen Announces Positive CHMP Opinion for JULUCATM▼ (dolutegravir/rilpivirine)23.3.2018 15:46Tiedote

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending marketing authorisation for JULUCA™ (dolutegravir 50mg [ViiV Healthcare UK Ltd]/rilpivirine 25mg [Janssen Sciences Ireland UC]). Dolutegravir/rilpivirine is a single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase strand transfer inhibitor (INSTI).1 “We are delighted to be one step closer to bringing JULUCA™ to people living with HIV in Europe,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. “Building on our 25-year c

Aitheon Executives Educate World Leaders on Benefits, Challenges of AI at the Annual World Government Summit in Dubai23.3.2018 15:00Tiedote

Aitheon, makers of the world’s first blockchain-powered platform to solve real problems by integrating AI, robotics, IoT, human specialists and cryptocurrency, announced today that executives from the company held a series of high-level briefings with world leaders at the Annual World Government Summit in Dubai. Briefings covered the benefits and challenges of AI, and revolutionary new solutions to world challenges made possible by transformative new technologies. (Read the full release at This press release features multimedia. View the full release here: Aitheon founder and CEO, Andrew Archer, and Chief Strategy Officer, Ryan Burleson, were invited to brief leaders at the Summit by Cyrus Hodes, Co-founder and Director of the AI Initiative, an undertaking of the Future Society at Harvard University’s Kennedy School. Archer and Burleson addressed a variety of AI-related topics, including the impact of AI on

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