ERYTECH Reports Third Quarter 2017 Financial Results and Provides Business Update
-
Presented full results of Phase 2b trial of eryaspase for the
treatment of second-line metastatic pancreatic cancer at ESMO 2017
Congress and met with theU.S. Food & Drug Administration (FDA ) to discuss plans for a proposed pivotal Phase 3 trial -
Resubmitted Marketing Authorization Application (MAA) to
the European Medicines Agency (EMA) for eryaspase (GRASPA®) for the
treatment of patients with relapsed or refractory (R/R) acute
lymphoblastic leukemia (ALL) in
October 2017 - Completed dosing of three treatment cohorts in U.S. Phase 1 dose-escalation trial of eryaspase in first-line adult ALL patients and determined the recommended dose for further development in this indication
-
Cash position of €80.3 million as of
September 30, 2017
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 theEuropean Society for Medical Oncology (ESMO) 2017Congress inMadrid . InOctober 2017 , the Company met with theFDA 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 inthe United States andEurope . 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.
-
In September, ERYTECH presented preclinical data on its eryminase
and erymethionase programs at the 13th
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 ofDecember 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'sApril 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 atSeptember 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 onMarch 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
About ERYTECH and eryaspase (GRASPA®): www.erytech.com
Founded in
The Company’s lead product, eryaspase, also known under the trade name GRASPA®, 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. L-asparaginase has been a standard component of multi-agent chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), but side effects limit treatment compliance, especially in adults and patients with weak performance status. With its improved safety profile, eryaspase aims to provide L-asparaginase to patients who cannot tolerate current non-encapsulated asparaginases.
ERYTECH produces eryaspase at its own GMP-approved and operational
manufacturing site in
In addition to eryaspase, ERYTECH is developing two other product candidates, erymethionase and eryminase, that focus on using encapsulated enzymes to target cancer metabolism and induce tumor starvation. ERYTECH is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies (ERYMMUNE) and enzyme replacement therapies (ERYZYME).
ERYTECH is listed on
Financial Information
This press release contains financial information relating to results
for the three and nine months ended September 30, 2017. These amounts
are unaudited, are subject to completion of financial closing procedures
that could result in changes to the amounts, and do not present all
information necessary for an understanding of our financial condition as
of
Forward-looking information
This press release contains forward-looking statements, forecasts and
estimates with respect to the clinical development plans, business and
regulatory strategy, 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. They include all matters that are not historical facts.
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 with the French
Autorité des Marchés Financiers, and
Disclaimer
This announcement does not, and shall not, in any circumstances
constitute a public offering nor an invitation to solicit the interest
of the public in
The distribution of this document may, in certain jurisdictions, be restricted by local legislations. Persons into whose possession this document comes are required to inform themselves about and to observe any such potential local restrictions.
This announcement is not an advertisement and not a prospectus within
the meaning of Directive 2003/71/EC of the European Parliament and of
the Council of
With respect to the member States of the European Economic Area, no action has been undertaken or will be undertaken to make an offer to the public of the securities referred to herein requiring a publication of a prospectus in any relevant member State. As a result, the securities may not and will not be offered in any relevant member State except in accordance with the exemptions set forth in Article 3(2) of the Prospectus Directive or under any other circumstances which do not require the publication by the Company of a prospectus pursuant to Article 3 of the Prospectus Directive and/or to applicable regulations of that relevant member State.
This document does not constitute an offer to the public in
This document is only being distributed to, and is only directed at,
persons in the
This document does not constitute an offer of securities for sale nor
the solicitation of an offer to purchase securities in
View source version on businesswire.com: http://www.businesswire.com/news/home/20171106006429/en/
Source:
ERYTECH
Naomi Eichenbaum
Director of Investor
Relations
+33 4 78 74 44 38
+1 917-312-5151
naomi.eichenbaum@erytech.com
or
The
Ruth Group
Investor relations
Lee Roth, +1
646-536-7012
lroth@theruthgroup.com
or
Media
relations
Kirsten Thomas, +1 508-280-6592
kthomas@theruthgroup.com
or
NewCap
Investor
relations
Julien Perez
or
Media relations
Nicolas
Merigeau
+33 1 44 71 98 52
erytech@newcap.eu