Pharnext: First-Half 2017
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|
|Research & development expenses||(7,610)||(5,740)|
|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: https://www.pharnext.com/en/investors/
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: www.pharnext.com
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.
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
Om Business Wire
(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
Summer Business with Yourtyres.co.uk: New Shop Feature and High-Performance Tyre Models16.3.2018 14:11 | Pressemelding
Each year, summer trade means great challenges for car garages and tyre dealers. As a result and at just the right time, Yourtyres.co.uk, the online trade customer shop by Europe’s leading online tyre dealer Delticom, is introducing a new feature intended to make the daily work of the shop’s customers easier: An advice mode is available from now on at Yourtyres.co.uk. When changing from the purchasing to the sales view, the individual end customer prices are displayed instead of the actual purchase prices. In order to use this feature, users of Yourtyres.co.uk simply have to insert their individual markups for the different item groups. From the markup and the purchase price, the online shop automatically calculates the personal end customer price. The usual purchasing view is also still available. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005448/en/ An advice mode immediately helps trade customers use the full pot
Available Now: The Smartphone Made for the Way We Communicate Today, the Galaxy S9 and S9+16.3.2018 12:00 | Pressemelding
Samsung Electronics America, Inc. announced that the new, award-winning Galaxy S9 and Galaxy S9+, which have been recognized by smartphone reviewers worldwide for their best-in-class display, design and camera, are now available for purchase at U.S. wireless network providers and retail stores. The phones come in three colors: Midnight Black, Coral Blue, and the new Lilac Purple. The Galaxy S9 has a suggested retail price of $719.99, while the Galaxy S9+ is available for $839.99. Both unlocked and carrier versions of the Galaxy S9 and Galaxy S9+ are also available for purchase on Samsung.com. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005175/en/ Designed for the way we communicate today, Samsung's new Galaxy S9 and Galaxy S9+ are available in the U.S. at wireless network providers, retailers and on Samsung.com. (Photo: Business Wire) “The Galaxy S9 and S9+ are designed for the visual and social generation—the consum
CONQUEST Group Announced the Expansion of its Asset Management Business with the Appointment of Philippe Taillardat to the Role of Director16.3.2018 09:00 | Pressemelding
Philippe Taillardat brings to CONQUEST over 25 years of Asset Management and Investment Banking experience, primarily in principal investing, financial advisory, equity and debt financing across global infrastructure and sustainable energy sectors. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005030/en/ Philippe Taillardat (Photo: CONQUEST Group) Philippe was most recently Co-Head of Infrastructure Investments Europe at First State Investments, which he helped transform into one of the leading billion+ European infrastructure fund manager in core / core+ strategies. Earlier in his career, Philippe held various senior banker and investment roles at Amundi, Credit Agricole CIB, Credit Suisse, AXA and BNP Paribas. Frédéric Palanque, Managing Director of CONQUEST Group, said, "We are delighted to welcome such a recognized professional. CONQUEST is trusted for providing value-added advice in complex and highly confidential
AccelStor All-Flash Solutions Unlock Data Possibilities for AI and Cloud16.3.2018 09:00 | Pressemelding
AccelStor, an innovative all-flash array (AFA) provider for the big data era, is excited to announce its participation in the upcoming Cloud Expo Europe, taking place from March 21 to 22 at Booth C1850 in the ExCel London exhibition centre. Besides presenting latest all-flash storage solutions breaking through performance and availability barriers for artificial intelligence (AI), virtualization and private cloud, AccelStor will present a live demonstration of its new generation NeoSapphire high availability models, one of the highlights not to be missed this year. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005010/en/ AccelStor's new generation NeoSapphire High Availability all-flash array AccelStor NeoSapphire all-flash arrays are highly integrated with virtualization and private cloud platforms, supporting VMware vSphere and OpenStack Cinder. NeoSapphire’s “high availability” series features symmetric active-activ
Westinghouse Completes First Major Decommissioning Work at a Nordic Commercial Nuclear Reactor16.3.2018 08:45 | Pressemelding
Westinghouse Electric Company announced today that it has completed a major decommissioning project at the former Barsebäck nuclear power plant in Skåne, Sweden. Barsebäck Unit 2 ceased operation in 2005 and decommissioning work began in August 2016. Westinghouse’s scope of work included the underwater segmentation and packaging of the reactor vessel internals, as well as the upfront engineering studies and equipment manufacturing and qualification. “Westinghouse is proud to deliver this major decommissioning project on time and on budget,” said Yves Brachet, Westinghouse senior vice president, Global Decommissioning, Decontamination, Remediation and Waste Management. “Our global expertise in this area will help our customers in the Nordic region to safely manage a variety of end-of-life opportunities for commercial nuclear power plants.” Leadership at Barsebäck Kraft AB (BKAB) is equally satisfied with this successful initial step of the first dismantling of a commercial nuclear power
Lighting Manufacturer LTS Licht & Leuchten, Part of the Fargerhult Group, to Offer Selected Spot- & Downlights with Seoul Semiconductor’s SunLike Series Natural Spectrum LEDs16.3.2018 08:02 | Pressemelding
Seoul Semiconductor, a global innovator of LED products and technology, announced that its SunLike Series natural spectrum LEDs, which implement light closest to the spectrum of natural sunlight, has been adopted for selected luminaires of LTS Licht & Leuchten GmbH, a German manufacturer of high-quality luminaires for hospitality, retail, and office applications. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005206/en/ LTS Jett 100 spotlights equipped with SunLike LED technology (Photo: Business Wire) LTS has adopted SunLike natural spectrum LEDs for selected products, including the Jett 100 and CSA 60 spotlights. A series of spotlights with a discreet and individual appearance, and clear, straightforward design lines, Jett spotlights harmoniously blend in with any type of retail application. The high color rendering and superior luminous intensity of these spotlights enable lighting designers to achieve accentuated ar