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ERYTECH Business Update and Financial Results for the First Half of 2014LYON, France --(Business Wire)-- Regulatory News : ERYTECH (Paris:ERYP) (Euronext Paris: FR0011471135 - ERYP), the French biopharmaceutical company that develops innovative 'tumor starvation' treatments for acute leukemia and other oncology indications with unmet medical needs, provides a business update and reports its financial results for the period ending June 30, 2014. Business Highlights
Financial Highlights
Upcoming Milestones
"ERYTECH has made important progress during the first half of 2014. We have advanced our clinical trials in acute leukemia according to plan and we have made substantial headway in broadening our scope in solid tumors. We are also advancing our preclinical pipeline with new products in oncology. In addition we were able to strengthen our shareholder structure, with additional specialized investors in the US and Europe, as well as our board, with two new independent directors.", commented Gil Beyen, Chairman and Chief Executive Officer of ERYTECH. Business Update Phase III clinical study in ALL on track for results early Q4 In August 2013, ERYTECH completed patient enrollment in its pivotal Phase III study in Acute Lymphoblastic Leukemia (ALL). The last one-year follow up visit took place in August. Data base cleaning is ongoing and ERYTECH expects to communicate top-line results early Q4. The study is comparing GRASPA® with native asparaginase in a randomized, controlled, multicenter clinical trial with 80 children and adults suffering from relapsing or refractory ALL. The study was launched in 2009 as a Phase II/III study with an adaptive design protocol. International sites opened in Phase IIb AML study and positive DSMB assessment after first 60 patients In March 2013, ERYTECH initiated a multicenter, open, randomized, controlled Phase IIb trial evaluating the efficacy and tolerability of GRASPA® in the treatment of newly diagnosed Acute Myeloid Leukemia (AML) patients, over 65 years of age, unfit for intensive chemotherapy. Today, more than half of a total of 123 patients have been enrolled in the study in 15 active centers in France. The company has recently received regulatory authorizations for this trial in Spain, Finland, Germany and Italy, and the first 4 sites outside France have been initiated. The opening of these European centers will internationalize the study and further accelerate patient enrollment. Last week the company announced that an independent Data and Safety Monitoring Board (DSMB) completed its second safety assessment of the study and unanimously recommended continuation of the trial without modification. This second DSMB assessment was based on a pre-planned safety analysis on the first 60 patients included in the study and with a minimum of 1 month follow-up. A first DSMB assessment took place at the end of 2013 when 30 patients had been treated in the study. The next step will be another DSMB analysis, this time for safety and futility, when 60 patients will have experienced an event in the study. This analysis is foreseen by the end of this year. Phase II trial launched in pancreatic cancer; first patient enrolled After the completion of a Phase I study in late stage pancreas cancer, in which the tolerability of ERY-ASP was found acceptable in this fragile patient population, ERYTECH launched a Phase II study in 2014 in second line treatment of patients with progressive metastatic pancreas cancer. Clinical trial authorization was received in April by the ANSM, the French authority for drug safety. The first patient was enrolled in July 2014. The study is planned for 90 patients whereby ERY-ASP in addition to the standard of care will be compared to the standard of care alone in a 2-to-1 randomization. The primary endpoint is progression-free survival (PFS) at 4 months. Professor Pascal Hammel, gastro-enterologist specialized in digestive oncology at Hôpital Beaujon (Clichy-Paris, France), is the primary investigator of the study. Phase I/II study in ALL launched in the USA; first patient enrolled Having received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) in 2013 to start a Phase I clinical trial of ERY-ASP in ALL, ERYTECH has launched a dose escalating study in 12 to 18 ALL patients earlier this year. Three centers are currently open for patient recruitment (The University of Chicago, Duke University Medical Center and Ohio State University) and the first patient was recently enrolled and treated. The investigational drug has been produced at ERYTECH's manufacturing facility in Philadelphia. Through a manufacturing agreement with the American Red Cross, this facility is operational for GMP production of clinical batches. Professor Larson, Director of the Hematological Malignancies Clinical Research Program at the University of Chicago is the principal investigator of the study. Orphan drug designation granted to ERY-ASP in AML in the USA In March 2014, FDA granted Orphan Drug Designation (ODD) to ERY-ASP in AML. In the USA, an ODD is generally granted to drugs or biologics intended for treatment of rare diseases and disorders of high unmet medical need, affecting fewer than 200,000 people. This designation contains additional incentives to the sponsor, including seven years of US market exclusivity for the drug after regulatory approval. The latest ODD is the seventh for ERYTECH. GRASPA®/ERY-ASP now benefits from ODD in all three of its lead indications: ALL, AML and pancreas cancer, both in Europe and the USA. New product candidate added and preclinical development programs on track Progress has been made in the preclinical development in the field of oncology:
IP portfolio reinforced During the first half of 2014, ERYTECH received notice of allowance from the European Patent Office of a key patent covering its lead product ERY-ASP for the treatment of pancreas cancer. The patent entitled "Medicament for the Treatment of Cancer of the Pancreas" was already granted in Australia, Israel and Singapore. ERYTECH's core process patent was also recently granted in India. This patent entitled "Lysis/Resealing Process for Preparing Erythrocytes" was already granted in Europe, US, Japan, China, Hong-Kong, Australia and South-Korea. As of mid-2014 ERYTECH was the holder of 13 patent families, covering the technology platform and applications thereof in and outside oncology, as well as an exclusive license from the National Institutes of Health (USA), covering a diagnostic method to predict the efficacy of L-asparaginase. Board of Directors strengthened with two new independent members At the General Shareholder's meeting in June 2014, two new independent members have been appointed to the Board of Directors:
Kurma Life Science Ventures, represented by Mrs Vanessa Malier and representing Idinvest on the ERYTECH board has resigned from the Board. The Board of Directors wish to thank Idinvest, Kurma Life Sciences and Vanessa Malier for their contributions to the company. Financial Update Shareholder base further internationalized after successful share replacement operation In February 2014, certain of the historical institutional investors of ERYTECH have sold part of their holdings to new investors in a successful share replacement operation. Under the deal, 17.5% of its capital initially held by these shareholders was placed with new specialized life sciences investors based in the USA and Europe. The USA represented more than 35% of the placement. Net loss reduced and operating expenses stable notwithstanding increased activity level The net loss for the first half of 2014 amounted to €3.2 million, compared to € 4.1 million for the same period the year before. This decrease of €0.9 million is essentially the result of a reduction of financial charges related to loans that have been converted at the time of the IPO in May 2013, by €1.1 million. This decrease was, partly compensated by somewhat lower grants income and higher operational charges (each by approx. €0.1 million). The slight increase in operational expenses is caused by a decrease in total Research & Development (R&D) and Clinical trial costs by €0.4 million and an increase in General & Administration (G&A) costs with €0.5 million.
Solid cash balance of € 12.3 million3 ERYTECH has a strong balance sheet with cash and cash equivalents of €12.3 million at end of June 2014, compared with €15.1 million on December 31, 2013. Total cash consumption for the period has been €2.8 million, approx. €0.5 million per month. ERYTECH's key financial figures for the first half of 2014 compared with the same period the previous year are summarized below: Key figures (in thousands of euros):
The financial report for the semester ending June 30, 2014, approved by the Board of Directors on August 29, 2014, is available on ERYTECH's website (www.erytech.com). The report has been subject to a limited review procedure by the company's statutory auditors. Next financial updates:
Upcoming participations at investor conferences:
About ERYTECH: www.erytech.com
ERYTECH is a French biopharmaceutical company providing new prospects
for cancer patients, particularly those with acute leukemia and selected
solid tumors. The company is also developing other indications in solid
tumors and certain orphan indications outside oncology. For more information about the Company, please read About ERYTECH and ERY-ASP/GRASPA Forward-looking information This document may contain forward-looking statements, forecasts and estimates ("Statements") with respect to the financial situation, the results of operations, the strategy, the project and to the anticipated future performance of ERYTECH Pharma. Documents filed by ERYTECH Pharma with the French Autorité des Marchés Financiers (www.amf-france.org), also available on our website (www.erytech.com) describe such risks and uncertainties for which ERYTECH Pharma makes no representations or warranty as to their accuracy or fairness. Furthermore, such Statements only speak as of the date of the publication of this document. ERYTECH disclaims any obligation to update any such Statements except to the extent required by French law. For more information about Forward-looking information, please read Forward-looking information
1 ERY-ASP is the name used for GRASPA® outside Europe and for
indications other than ALL and AML. The GRASPA® brand name has been
licensed to Orphan Europe for the commercialization of the product in
ALL and AML in Europe.
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