- Ongoing review by European Medicines Agency (EMA) of Marketing Authorization Application (MAA) for eryaspase (GRASPA®) for the treatment of acute lymphoblastic leukemia (ALL);
- Completed enrollment of patients in Phase 2 studies of eryaspase in acute myeloid leukemia (AML) and pancreatic cancer;
- Strengthened executive management team and board of directors;
- Cash position of €30.4 million at September 30, 2016
- ERYTECH's MAA for GRASPA® to treat relapsed and refractory ALL, submitted in September 2015, remains under review by the EMA's Committee for Human Medicinal Products (CHMP). The Company received its Day 180 List of Outstanding Issues and expects to be in a position to receive an opinion from the CHMP regarding the approvability of GRASPA® during 2017.
- The Phase 2 trial of eryaspase (GRASPA®) for the treatment of pancreatic cancer completed enrollment of 141 patients in September. In this study, eryaspase is being evaluated in combination with the standard of care (currently Gemcitabine or FOLFOX regimen) as compared to the standard of care alone in a 2-to-1 randomization for second-line treatment of metastatic pancreatic cancer. The Company expects to report primary results of the study in Q1 2017.
- The Phase 2b trial of eryaspase (GRASPA®) for the treatment of AML completed enrollment of a total of 123 patients in August, and is on track for reporting of primary data in the second half of 2017. In this study, eryaspase is being evaluated in combination with low-dose cytarabine and compared with low-dose cytarabine alone in a 2-to-1 randomization.
- The US Phase 1 study in adult ALL patients has completed enrollment in the second patient cohort and is expected to confirm the recommended dose for Phase 2 in Q1 2017.
- Preclinical programs with new product candidates ERY-MET and ERY-ADI are progressing, and the Company is further developing the usage of the ERYCAPS platform in immuno-oncology and enzyme replacement therapies.
- ERYTECH has entered into an agreement with Invetech, a global leader in instrument development and custom automation, for the further automation and scale-up of its ERYCAPS encapsulation equipment.
- The Company strengthened its executive management through the appointments of Dr. Alexander Scheer as Chief Scientific Officer (CSO) and Jean-Sébastien Cleiftie as Chief Business Officer (CBO). Dr. Scheer has over 15 years of experience in R&D and has a strong understanding of the life science industry in multiple therapeutic areas including oncology. Mr. Cleiftie has over 15 years of experience in drug development, life science venture capital, pharmaceutical business development and licensing within the U.S. and European biopharmaceutical ecosystem.
- The Company also appointed Allene M. Diaz to its Board of Directors, initially as a non-voting member ('censeur'). Ms. Diaz has more than 20 years of experience in the global biopharmaceutical and biotechnology field.
As of September 30, 2016, ERYTECH had cash and cash equivalents totaling €30.4 million, compared with €36.5 million on June 30, 2016 and €45.6 million on December 31, 2015. Total net cash utilization was €6.1 million in the third quarter of 2016 and €15.2 million for the nine-month period ended September 30, 2016. As with the net loss for these periods, net cash utilization during the three and nine months ended September 30, 2016 reflected increased activity in product development and the strengthening of the Company's operations.The Company reiterated its earlier guidance that total cash utilization for the full year 2016 is expected to be in the range of €18 million to €20 million. The financial results for third 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 therapies 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 third quarter of 2016, we continued to achieve important milestones in the clinical development of our products and strengthened our business operations. Both of our ongoing GRASPA studies in AML and pancreatic cancer are fully enrolled, with reporting of primary data expected in 2017. The outcomes of these studies will determine our future development and commercial plans for GRASPA in these indications. We also continue to focus on advancing our preclinical programs, which aim to further expand the application of our proprietary ERYCAPS platform technology. The new appointments to the executive leadership and Board of Directors of ERYTECH will further support the advancement of our clinical and preclinical pipeline, and will be important as we look toward maximizing the commercial impact of our programs in the future. Finally, we submitted our responses to the EMA's Day 120 List of Questions related to our European Marketing Authorization Application for GRASPA in ALL this summer, and we are now working to address the Day 180 List of Outstanding Issues. We continue to expect a decision on the approvability of GRASPA in 2017." Q3 2016 Business Update Conference Call Details As a reminder, ERYTECH management will hold a conference call and webcast on Friday, November 4, 2016 at 15:00 CET / 10:00am EDT to review the Q3 2016 operational highlights. 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.
Investors and analysts wishing to participate can access the call via the following teleconferencing numbers:
|USA: +1 8778874163||United-Kingdom: +44 2030432440|
|Switzerland: +41 225809022||Germany: +49 69222229031|
|France: +33 172001510||Belgium: +32 24029640|
|Sweden: +46 850334664||Finland : +358 942599700|
|Netherlands: + 31 107138194|
|USA: +1 877 64 230 18|
|United-Kingdom: +44(0) 2033679460|
|France: +33(0)1 72 00 15 00|
- Financial highlights for the 4 th quarter and full year 2016: March 2, 2017 (after market close), followed by a conference call and webcast on March 3, 2017 (3:00pm CET/10:00am ET)
- Bryan Garnier Healthcare Conference, November 15, 2016 in Paris
- Jefferies Global Healthcare Conference, November 16-17, 2016 in London
- Eigenkapitalforum, November 21-24, 2016 in Frankfurt
- ODDO Midcap Forum, January 5-6, 2017 in Lyon
- J.P. Morgan Healthcare Conference, January 9-13, 2017 in San Francisco
- Leerink Partners Global Healthcare Conference, February 15-16, 2017 in New York
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. ERYTECH produces eryaspase 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. The EMA and the U.S. Food and Drug Administration (FDA) have granted orphan drug designations for eryaspase for the treatment of ALL, AML and pancreatic cancer.In addition to eryaspase, ERYTECH is developing two other product candidates that focus on using encapsulated enzymes to induce tumor starvation. The company is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies and enzyme replacement therapies. 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). CONTACTS
|ERYTECH Gil BeyenChairman and CEO Eric SoyerCFO and COO||The Ruth Group Lee RothInvestor relations Kirsten ThomasMedia relations||NewCap Julien PerezInvestor relations Nicolas MerigeauMedia relations|
|+33 4 78 74 44 38 email@example.com||+1 646 536 7012 firstname.lastname@example.org+1 508 280 6592 email@example.com||+33 1 44 71 98 52 firstname.lastname@example.org|