LYON, Frankrijk–(BUSINESS WIRE)– Regulatory News:
ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP), de Franse biofarmaceutische ontwikkelaar van innovatieve behandelingen van acute leukemie en andere kankersoorten door middel van ‘uithongering’ van tumoren, geeft vandaag een zakelijke update en rapporteert zijn halfjaarcijfers van de periode die eindige op 30 juni 2016.
Belangrijkste gebeurtenissen in het eerste halfjaar van 2016:
- De aanvraag van een vergunning voor het in handel brengen van GRASPA voor de behandeling van ALL wordt behandeld door het Comité voor geneesmiddelen voor menselijk gebruik (CHMP) van het Europees Geneesmiddelenbureau. In juli 2016 reageerde het bedrijf op de vragenlijst die het CHMP op dag 120 van de procedure opstelt. ERYTECH verwacht de lijst van lopende kwesties (dag 180) voor het einde van deze maand te ontvangen. Op basis van de voorlopige feedback denkt het bedrijf aanzienlijke vooruitgang te boeken bij het beantwoorden van de vragen van het CHMP. Het oplossen van enkele blijvende problemen kost waarschijnlijk meer tijd dan aanvankelijk gedacht. Het bedrijf verwacht dat het CHMP in de loop van 2017 oordeelt over GRASPA.
- De patiëntwerving is afgerond voor Fase 2b van het onderzoek naar eryaspase (GRASPA®) voor de behandeling van AML. In totaal nemen 123 deel aan het onderzoek, dat op schema loopt voor rapportage van primaire data in de tweede helft van 2017. Het onderzoek vindt plaats op meer dan 20 Europese locaties.
- Met meer dan 130 deelnemers is de patiëntwerving bijna klaar voor fase 2 van het onderzoek naar eryaspase (GRASPA®) tegen alvleesklierkanker. Het onderzoek loopt op schema voor rapportage van primaire data aan het begin van 2017.
- Het octrooibureau van de Verenigde Staten heeft het patent Composition and Therapeutic Anti-tumor Vaccine uitgegeven, dat ERYTECHs gepatenteerde ERYCAPS-platform voor immunotherapieën omschrijft. De octrooibureaus van Japan en Zuid-Korea kenden ERYTECH ook een patent toe, Medicament for the Treatment of Cancer of the Pancreas. Dit patent omschrijft het gebruik van eryaspase (GRASPA®) voor de behandeling van alvleesklierkanker
- Het bedrijf opende een Amerikaans kantoor in Cambridge, in de staat Massachusetts, en heeft zijn Amerikaanse team voor klinische ontwikkeling rond.
- Allene M. Diaz is benoemd tot bestuursraadslid zonder stemrecht, met het voornemen haar in januari 2017 voor te dragen als directielid, voorafgaand aan de algemene aandeelhoudersvergadering.
ERYTECH Reports Business and Financial Update for the First Half of 2016
LYON, France–(BUSINESS WIRE)– Regulatory News:
ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP), a French biopharmaceutical company developing ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, today provided a business update and reported its financial results for the six month period ended June 30, 2016.
First Half and Recent Business Highlights
ERYTECH’s key financial figures for the first six months of 2016, compared with the same period of the previous year, are summarized below:
Key figures (in thousands of euros):
Net loss for the first half of 2016 was €10.3 million, compared to net loss of €6.5 million for the same period of last year. The €3.8 million increase reflected increased expenses to advance the Company’s preclinical and clinical development programs. The increase was driven by higher service and contracting fees, mostly related to the clinical and regulatory progress of product development projects, and by higher personnel costs resulting from the staffing of key positions in the preclinical, clinical and pharmaceutical operations domains intended to prepare the Company for further development, both in Europe and in the United States. Other income, which was mostly comprised of research and development tax credits and grants, increased in the same period and in approximately the same proportion.
As of June 30, 2016, ERYTECH had cash and cash equivalents totaling €36.5 million, compared with €45.6 million on December 31, 2015.
Net cash utilization for operating and investment activities was €4.1 million in the second quarter of 2016 and €9.2 million in the first half of 2016, compared with net cash utilization of €8.1 million in the second half of 2015, excluding the net cash impact of the December 2015 capital raise. As with net loss in the first half of 2016, net cash utilization reflected the increase in expenses related to product development and the strengthening of the Company’s operations.
The financial results for second quarter 2016 are in line with the Company’s expectations and established strategy for 2016, which focuses on advancing the clinical development of its innovative treatments for acute leukemia and other oncology indications in Europe and the United States.
Gil Beyen, ERYTECH’s Chairman and Chief Executive Officer commented, “In the first half of 2016, we made continued progress toward several important objectives. We are pleased to have submitted a response to the CHMP’s Day 120 List of Questions related to our European Marketing Authorization Application for GRASPA for the treatment of ALL. We continue to advance GRASPA forward with the goal of obtaining approval in Europe and we have made significant progress in the ongoing clinical development of GRASPA for other oncology indications, including the recent completion of patient enrollment in our Phase 2b trial for the treatment of AML and the anticipated upcoming complete patient enrollment in our Phase 2 trial for treatment of pancreatic cancer. We have also continued to make progress on our preclinical programs and have further strengthened our organization, especially in the U.S.”
First Half 2016 Conference Call Details
As a reminder, ERYTECH management will hold a conference call, which will be broadcast live over the Internet, on Wednesday, September 07, 2016 at 15:00pm CET / 9:00am EDT to review the Q2 and 1H 2016 financial and operational highlights. Gil Beyen, Chairman and CEO, Eric Soyer, CFO and CFO and Iman El-Hariry, CMO will deliver a brief presentation, followed by a Q&A session.
Investors and analysts can access the call via the following teleconferencing numbers:
Confirmation Code: 79702432#
A live Internet webcast of the call will be available via the following link: http://www.anywhereconference.com?UserAudioMode=DATA&Name=&Conference=135303493&PIN=79702432
Following the live webcast, a telephonic replay will be available for 90 days. To listen to the replay, please dial:
USA: +1 877 642 3018
Confirmation Code: 303493#
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:
Upcoming participations at investor conferences:
About ERYTECH and eryaspase (eryasp/GRASPA®): 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 has recently filed for European Marketing Authorization for its lead product candidate, eryaspase, also known as eryasp and under the trade name GRASPA®, following positive efficacy and safety results from its completed Phase 2/3 pivotal clinical trial of GRASPA 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 of GRASPA in Europe in elderly patients with newly diagnosed AML, each in combination with chemotherapy.
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. Every year over 50,000 patients in Europe and the United States are diagnosed with ALL or AML. For about 80% of these patients, mainly adults and relapsing patients, current forms of L-asparaginase cannot be used due to their toxicity or as a result of allergic reactions. ERYTECH believes that the safety and efficacy profile of eryaspase/GRASPA®, as observed in its Phase 2/3 pivotal clinical trial, offers an attractive alternative option for the treatment of leukemia patients.
ERYTECH believes that eryaspase 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. In addition to its current product candidates that focus on using encapsulated enzymes to induce tumor starvation, ERYTECH is exploring the use of its platform for developing immunotherapy products and enzyme replacement therapies.
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted orphan drug designations for eryaspase/GRASPA for the treatment of ALL, AML and pancreatic cancer. ERYTECH produces the product 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.
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).
This press release may contain forward-looking statements and estimates with respect to the financial position, results of operations, business strategy, plans, objectives 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. Statements in this press release that are not historical facts are forward-looking statements. 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 the publication 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.