- Business Wire
ERYTECH Pharma (Euronext: ERYP - Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today provided a business update and reported its financial results for the year ended December 31, 2017.
â2017 was a transformative year for ERYTECH with the achievement of a number of important clinical, regulatory and financial objectives,â said Gil Beyen, Chairman and CEO of ERYTECH. âWe are extremely pleased with the positive outcome of our Phase 2b trial of eryaspase in second-line metastatic pancreatic cancer and the success of our two financing operations, which generated gross proceeds of approximately $226 million, and our resulting dual listing on Nasdaq and Euronext Paris. With the proceeds of these transactions, we believe we are well capitalized to advance our pipeline programs, most notably the pivotal Phase 3 clinical trial of eryaspase for the treatment of second-line metastatic pancreatic cancer. We met with the FDA to discuss the proposed design of this trial and also obtained similar feedback from the CHMP. We are also exploring the launch of proof of concept studies in first-line pancreatic cancer, and other solid tumor indications, beginning with triple negative breast cancer. Lastly, we resubmitted our MAA for potential approval of eryaspase (GRASPAÂ®) for the treatment of relapsed and refractory ALL in Europe. We expect our momentum to continue as we progress towards potential approval in ALL, and anticipate significant advances from other clinical and preclinical research programs in our pipeline.â
Full Year and Recent Business Highlights
Full Year 2017 Financial Results
|Â||In thousands of euros||Â||Â||Â||FY 2017||Â||Â||Â||FY 2016||Â|
|Â||Total operating income||Â||Â||Â||3,364||Â||Â||Â||4,138||Â|
|Â||Research and development||Â||Â||Â||(25,463)||Â||Â||Â||(19,720)||Â|
|Â||General and administrative||Â||Â||Â||(8,791)||Â||Â||Â||(6,808)||Â|
|Â||Total operating expenses||Â||Â||Â||(34,254)||Â||Â||Â||(26,528)||Â|
|Â||Total operating loss||Â||Â||Â||(30,889)||Â||Â||Â||(22,390)||Â|
|Â||Financial income (loss)||Â||Â||Â||(2,644)||Â||Â||Â||488||Â|
|Â||Loss before tax||Â||Â||Â||(33,533)||Â||Â||Â||(21,902)||Â|
Net loss for the full year 2017 was â¬33.5 million, compared to â¬21.9 million in 2016. The â¬11.6Â million increase was primarily attributable to the increase in clinical and regulatory development expenses, related to the companyâs ongoing clinical programs in ALL, AML and pancreatic cancer, the continuation of its regulatory initiatives in Europe and preparatory work related to additional clinical programs. R&D expenses also comprise pre-clinical developments on additional product candidates and the broadening of the ERYCAPS platform to include the potential development of immune therapies and enzyme-related therapies.
Key News Flow and Milestones Expected over Next 12 Months
Full Year Results 2017 Conference Call Details
As a reminder, ERYTECH management will hold a conference call and webcast on Tuesday, March 13th, 2018 at 01:30pm CET / 08:30am EDT to business highlights and full year 2017 financials. 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.
The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 7997444#:
|USA: +1 8338186807||Â||Â||Â||Â||Â||United-Kingdom: +44 02031070289|
|Switzerland: +080 0836508||Â||Â||Â||Â||Â||Germany: +49 06922224728|
|France: +33 0176748988||Â||Â||Â||Â||Â||Belgium: +32 024003547|
|Sweden: +46 0856619361||Â||Â||Â||Â||Â||Finland: +358 0972519310|
|Netherlands: +31 0207075547||Â||Â||Â||Â||Â||Spain: +34 914142503|
The webcast can be followed live online via the link: https://edge.media-server.com/m6/p/qa7wj9by
An archived replay of the call will be available for 7 days by dialing (US & Canada): +1 833 818 6807, (UK): +44(0) 203 107 0289, (France): +33(0)1 726 74 89 88, (Spain): +34 91412503, Conference ID # 7997444#
An archive of the webcast will be available on ERYTECHâs website, under the âInvestorsâ section at investors.erytech.com
2018 Financial Calendar:
Upcoming Investor Conferences:
About ERYTECH: www.erytech.com
Founded inÂ Lyon, FranceÂ 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. ERYTECHâs initial focus is on the development of products that target the altered amino acid metabolism of cancer cells, depriving them of nutrients necessary for their survival.
The Companyâs lead product, eryaspase, also known under the trade name GRASPAÂ®, 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. L-asparaginase has been a standard component of multi-agent chemotherapy for the treatment of pediatric acute lymphoblastic leukemia (ALL), but side effects limit treatment compliance, especially in adults and patients with weak performance status.
Eryaspase demonstrated positive efficacy and safety results in various clinical trials in ALL, including in a Phase 2 study in patients over 55 years of age and in a Phase 2/3 trial in relapsed or refractory ALL patients, as well as in pancreatic cancer, where it achieved positive results in a Phase 2b trial of second-line treatment of patients with metastatic pancreatic cancer. ERYTECH is preparing for the launch of a pivotal Phase 3 clinical trial in second line pancreatic cancer and Phase 2 trials in first line pancreatic cancer and triple-negative breast cancer.
ERYTECH produces eryaspase at its own GMP-approved and operational manufacturing site inÂ LyonÂ (France), and at a site for clinical production inÂ PhiladelphiaÂ (USA). ERYTECH has entered into licensing and distribution partnership agreements for eryaspase for ALL and AML inÂ EuropeÂ with Orphan Europe (Recordati Group), and for ALL inÂ IsraelÂ with TEVA, which will market the product under the GRASPAÂ® brand name.Â The European Medicines AgencyÂ (EMA) and theÂ U.S. Food and Drug AdministrationÂ (FDA) have granted orphan drug designations for eryaspase for the treatment of ALL, AML and pancreatic cancer.
In addition to eryaspase, ERYTECH is developing erymethionase, methionine-Î³-lyase encapsulated in red blood cells, to target cancer cellsâ amino acid metabolism and induce tumor starvation. ERYTECH is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies (ERYMMUNE) and enzyme replacement therapies (ERYZYME).
ERYTECH is listed on the Nasdaq Global Select Market inÂ the United StatesÂ (ticker: ERYP) and on theÂ Euronext regulated market inÂ ParisÂ (ISIN code: FR0011471135, ticker: ERYP). ERYTECH is part of the CACÂ Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical results from and the development plans of eryaspase, 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, âbelievesâ, âanticipatesâ, âexpectsâ, âintendsâ, âplansâ, âseeksâ, âestimatesâ, âmayâ, âwillâ and âcontinueâ 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 ERYTECHÂ´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. Further description of these risks, uncertainties and other risks can be found in the Companyâs regulatory filings with the French AutoritÃ© des MarchÃ©s Financiers, the Companyâs Securities and Exchange Commission filings and reports, including in the Companyâs prospectus filed pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended, on November 13, 2017 and future filings and reports by the Company. 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 ERYTECHâs 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.
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