On November 6, 2017 ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP) (ADR: EYRYY), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells (“ERYTECH” or the “Company”), reported a business update and its financial results for the quarter ended September 30, 2017

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

.

Business Highlights

In September 2017, ERYTECH presented full results from its open-label, multi-center, randomized Phase 2b trial of eryaspase in combination with chemotherapy for the treatment of second-line metastatic pancreatic cancer at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress in Madrid. In October 2017, the Company met with the FDA to discuss further development of eryaspase for the pancreatic cancer indication and intends to meet with the EMA to also discuss the design of a Phase 3 clinical trial that the Company hopes to initiate during the third quarter of 2018. The Company expects that the Phase 3 clinical trial will be designed to study the safety and efficacy of eryaspase combined with chemotherapy in patients with second-line metastatic pancreatic cancer. The trial is expected to enroll approximately 400 to 600 patients across clinical sites in the United States and Europe. The Company expects the primary endpoint of the trial to measure overall survival, and the main secondary endpoints will include progression-free survival, objective response rate, disease control rate, quality of life and safety. ERYTECH is also considering proof-of-concept studies in first-line pancreatic cancer and other settings and has initiated further preclinical work to assess the combinability of eryaspase with other compounds used in the treatment of first-line pancreatic cancer patients.

In October 2017, the Company resubmitted its MAA for eryaspase (GRASPA) for the treatment of patients with R/R ALL to the EMA. The validation of the MAA by the EMA is ongoing, after which the EMA will begin its formal assessment.

In September 2017, the Company announced the determination of the recommended Phase 2 dose in its U.S. Phase 1 dose escalation trial of eryaspase (GRASPA) as a first-line treatment of adult ALL patients at the level of 100 U/kg. This dose had been previously recommended following ERYTECH’s Phase 2 trial in elderly ALL patients. It is also the dose level used in the Company’s Phase 2b trial in second-line, metastatic pancreatic cancer and in its ongoing Phase 2b trial in AML, from which top-line results are expected by the end of 2017.

Preclinical development activities of other product candidates are progressing:
In September, ERYTECH presented preclinical data on its eryminase and erymethionase programs at the 13th International Congress of Inborn Errors of Metabolism (ICIEM). Both programs underscore ERYTECH’s opportunities with companies active in the field of metabolic diseases and enzyme replacement therapies. Further proof of concept data are expected during the course of 2018.

ERYTECH continues to explore the use of its proprietary ERYCAPS platform to encapsulate tumor antigens within red blood cells as an innovative approach to cancer immunotherapy. The Company expects to complete preclinical proof-of-concept studies of ERYMMUNE during the course of 2018.
Financial Highlights

Net loss for the nine-month period ended September 30, 2017 was €20.8 million, compared to €16.1 million for the same period in the prior year. The €4.7 million increase reflected increased activity to advance the Company’s ongoing preclinical and clinical development programs and was primarily related to the clinical and regulatory progress of product development projects, and higher personnel costs incurred due to the previously announced staffing of key positions in the Company’s preclinical, clinical and pharmaceutical operations, to address the Company’s activity expansion and prepare the Company for the next stages of its development strategy.

As of September 30, 2017, ERYTECH had cash and cash equivalents totaling €80.3 million, compared with €88.6 million as of June 30, 2017 and €37.6 million as of December 31, 2016. Total net cash utilization was €8.3 million in the third quarter of 2017 and €22.8 million for the nine-month period ended September 30, 2017, excluding the €65.2 million net proceeds from the Company’s April 2017 capital raise.

The financial results for the three and nine months ended September 30, 2017 were in line with ERYTECH’s established strategy for 2017 and reflected the strengthening of the Company’s operations, which focuses on preparing the Company for its next stage of development, including its expected launch in 2018 of a Phase 3 clinical trial in second line metastatic pancreatic cancer in Europe and the United States. Management believes that its cash and cash equivalents available at September 30, 2017 are sufficient to fund our clinical trials that have already commenced, on the basis of its current cost structure and its ongoing programs, to ensure its viable going concern through the 2020 horizon.

Key newsflow and milestones expected over the next 12 months

Expect to report results from EU Phase 2b AML study in Europe
Meeting with CHMP on PDAC development plan
Meeting with FDA on ALL development plan
Potential initiation of Phase 3 trial in second-line PDAC in Europe and the U.S.
Potential initiation of clinical studies in first-line PDAC and other solid tumors
Potential launch of Phase 3 trial in first-line adult ALL
Potential launch of Phase 3 trial in AML
Expected initiation of erymethionase Phase 1 study

Next financial updates:

Financial highlights for the 4th quarter and full-year 2017: March 12, 2018 (after market close), followed by a conference call and webcast on March 13, 2018 (1:30pm CET/8:30am EDT)
Upcoming participations at investor conferences:

Jefferies Global Healthcare Conference, November 15-16, 2017, London
Actionaria, November 23-24, 2017, Paris
Geneva European Midcap Event, November 28-29, Geneva
Biomed Invest Securities, December 19, Paris
Investor access event at the J.P. Morgan Healthcare Conference, January 8-11, 2018, San Francisco
ODDO BHF Forum, January 11-12, 2018, Lyon