ERYTECH geeft update en rapporteert jaarcijfers 2016
LYON, Frankrijk–(BUSINESS WIRE)– ERYTECH Pharma (Parijs:ERYP) (ADR:EYRYY), het biofarmaceutische bedrijf dat innovatieve behandelingen van zeldzame kankervormen ontwikkelt op basis van zijn gepatenteerde platform ERYCAPS voor inkapseling van medicijnen in rode bloedcellen, heeft vandaag een update over het bedrijf gegeven en zijn jaarcijfers van 2016 (geëindigd op 31 december 2016) gerapporteerd.
“In 2016 hebben we belangrijke stappen gezet in onze pijplijn, ondanks onze beslissing de aanvraag van een Europese vergunning voor het in handel brengen van GRASPA hebben ingetrokken en vervolgens opnieuw hebben ingediend. We werken toegewijd aan de marktintroductie van GRASPA en zetten belangrijke stappen voor de eerste wettelijke goedkeuring van het medicijn”, zei Gil Beyen, besuursvoorzitter en ceo van ERYTECH. “Ons team werkt hard om de CHMP vereiste extra gegevens te verschaffen en we streven ernaar onze vergunningaanvraag deze zomer opnieuw in te dienen.”
ERYTECH Provides Business Update and Reports Financial Results for Full Year 2016 |
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LYON, France–(BUSINESS WIRE)– Regulatory News: ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP), the clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases based on its proprietary ERYCAPS platform, encapsulating therapeutic drug substances inside red blood cells, today provided a business update and reported its financial results for the year ended December 31, 2016. “In 2016, we made important progress moving our pipeline forward despite our decision to withdraw and resubmit our European Marketing Authorization Application for GRASPA. We are committed to bringing GRASPA to the market and continue to make significant strides in pursuing its first regulatory approval,” said Gil Beyen, Chairman and CEO of ERYTECH. “Our team is working diligently to provide the requested additional data to the CHMP and we plan to resubmit our MAA this summer. In addition, we presented important new findings related to the mechanism of action of GRASPA, as well as new preclinical data further supporting the anti-tumor activity of our new product candidate erymethionase (ERY-MET) in preclinical models. Looking ahead to 2017 we expect to reach several important milestones, most notably the results of our Phase 2 studies in pancreatic cancer and AML, the resubmission of the MAA for ALL, and the initiation of new trials. We strengthened our balance sheet with a successful private placement in the fourth quarter of 2016 and have the capacity to execute on our key strategic objectives for 2017. We strongly believe 2017 will be another transformative year in support of our mission of advancing novel anti-cancer therapies using our ERYCAPS technology for the benefit of patients in need.” Full Year and Recent Business Highlights
Full Year 2016 Financial Results
Net loss for the full year 2016 was €22.0 million, compared to €15.0 million in 2015. The €7.0 million increase was primarily due to the €8.2 million increase in operating expenses, primarily due to the increase in clinical and regulatory development expenses, related to ongoing clinical programs in ALL, AML and Pancreatic cancer, the continuation of regulatory developments in Europe and the preparation of further clinical programs. R&D expenses also include pre-clinical developments on additional product candidates and the expansion of the ERYCAPS platform to other modes of action for immune therapies and enzyme-related therapies. The increase in operating expenses was partially offset by an increase in operating income.
The consolidated financial accounts for the full year 2016, approved by the board of directors on March 1 st, 2017, are available on ERYTECH’s website ( www.erytech.com). Key newsflow and milestones expected over next 12 months
Full Year results 2016 Conference Call Details As a reminder, ERYTECH management will hold a conference call and webcast on Friday, March 03, 2017 at 15:00 CET / 9:00am EST to review the Q4 2016 operational highlights. Gil Beyen, Chairman and CEO, Eric Soyer, CFO and COO and Iman El-Hariry, CMO will deliver a brief presentation, followed by a Q&A session. Investors and analysts wishing to participate can access the call via the following teleconferencing numbers:
Confirmation Code: 35823698# The webcast can be followed live online via the link: Following the live call, a replay will be available for 90 days. To listen to the replay, please dial:
Confirmation Code: 307282# Additionally, an archive of the webcast will be available on the “Webcast” section of the Company’s investor relations site at www.erytech.com Next financial updates: Business Update and Financial Highlights for the 1 st quarter of 2017: May 18, 2017 (after market close), followed by a conference call and webcast on May 19, 2017 (3:00pm CET/9:00am ET). Upcoming participations at investor conferences:
About ERYTECH: www.erytech.com Founded in Lyon, France in 2004, ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, which uses a novel technology to encapsulate therapeutic drug substances inside red blood cells, ERYTECH has developed a pipeline of product candidates targeting markets with high unmet medical needs. ERYTECH’s initial focus is on the treatment of blood cancers, including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), by depriving tumors of nutrients necessary for their survival. ERYTECH plans to pursue regulatory approvals for its lead product candidate, eryaspase, also known under the trade name GRASPA®, having achieved positive efficacy and safety results from its completed Phase 2/3 pivotal clinical trial in Europe in children and adults with relapsed or refractory ALL. ERYTECH also has an ongoing Phase 1 clinical trial of eryaspase in the United States in adults with newly diagnosed ALL, and a Phase 2b clinical trial in Europe in elderly patients with newly diagnosed AML, each in combination with chemotherapy. ERYTECH believes that eryaspase also has the potential as a treatment approach in solid tumors and is conducting a Phase 2 clinical trial in Europe in patients with metastatic pancreatic cancer. Eryaspase consists of an enzyme, L-asparaginase, encapsulated inside donor-derived red blood cells. L-asparaginase depletes asparagine, a naturally occurring amino acid essential for the survival and proliferation of cancer cells, from circulating blood plasma. ERYTECH produces eryaspase at its own GMP-approved and operational manufacturing site in Lyon (France), and at a site for clinical production in Philadelphia (USA). ERYTECH has entered into licensing and distribution partnership agreements for eryaspase for ALL and AML in Europe with Orphan Europe (Recordati Group), and for ALL in Israel with TEVA, which will market the product under the GRASPA® brand name. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted orphan drug designations for eryaspase for the treatment of ALL, AML and pancreatic cancer. In addition to eryaspase, ERYTECH is developing two other product candidates that focus on using encapsulated enzymes to induce tumor starvation. The company is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies and enzyme replacement therapies. ERYTECH is listed on Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: ERYP) and is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes. ERYTECH is also listed in the U.S. under an ADR level 1 program (OTC, ticker EYRYY). Forward-looking information This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development plans, business and regulatory strategy, and anticipated future performance of ERYTECH and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond ERYTECH’s control. There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Documents filed by ERYTECH Pharma with the French Autorité des Marchés Financiers ( www.amf-france.org), also available on ERYTECH’s website ( www.erytech.com) describe such risks and uncertainties. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. ERYTECH disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in ERYTECH’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by law. View source version on businesswire.com: http://www.businesswire.com/news/home/20170302006094/en/ Contacts ERYTECH |