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ERYtech Pharma Reports First Half 2017 Financial Results And Provides Business Update



9/11/2017 11:42:33 AM

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Conference call and webcast scheduled for
Tuesday, September 12th at 02:30 pm CEST/08:30 am EDT

  • Positive final results from Phase 2b study of eryaspase (GRASPA®) for the treatment of metastatic pancreatic cancer presented at the European Society for Medical Oncology (ESMO) 2017 Congress
  • Meeting with the U.S. Food and Drug Administration (FDA) to seek guidance for further clinical development of eryaspase in pancreatic cancer planned
  • Process for resubmission of European Marketing Authorization Application (MAA) for GRASPA for the treatment of relapsed or refractory acute lymphoblastic leukemia (ALL) initiated and on track for filing in October
  • First patients enrolled in investigator-initiated study (NOPHO Study) in ALL
  • Entered into research collaborations with Queen’s University (Kingston, Canada) and the Fox Chase Cancer Center (FCCC) (Philadelphia, U.S.) to advance preclinical programs in metabolic diseases, and presented promising preclinical data of pipeline programs at several medical meetings during the first half of 2017
  • U.S. team strengthened with hiring of U.S.-based Investor Relations, Regulatory Affairs and Strategic Marketing team members
  • Successfully raised €70.5 million in gross proceeds in a private placement in April 2017
  • Solid cash position of €88.5 million as of June 30, 2017

ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY), 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 six-month period ended June 30, 2017.

The positive results of eryaspase in second-line metastatic pancreatic cancer have been highly significant for ERYTECH,” commented Gil Beyen, ERYTECH’s Chief Executive Officer. “Not only do these results open the door for eryaspase to become a potentially important therapy in the treatment of second-line metastatic pancreatic cancer, an area of high unmet medical need with very limited treatment options, they are also the basis for exploration of additional clinical development opportunities in this disease and in other solid tumors. Our capital raise in April significantly strengthened our balance sheet and enables us to build on these opportunities. The next key steps are meetings with the U.S. FDA, scheduled for October, and the Committee for Medicinal Products for Human Use, or CHMP, to be scheduled later in 2017, to discuss the development path and design of a potential Phase 3 study for eryaspase in pancreatic cancer. Concurrently, our preclinical teams are exploring other possible solid tumor indications in areas of high unmet medical need. In the meantime, we are preparing our MAA resubmission, including the supplementary data requested by the CHMP, for the potential EU approval of eryaspase for the treatment of relapsed or refractory ALL. We believe we have made substantial preclinical program advancements in oncology and metabolic diseases as part of our strategy to further expand our ERYCAPS technology.”


Read at BioSpace.com


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