ERYTECH Reports First Half 2017 Financial Results and Provides Business Update
Conference call and webcast scheduled for
- 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) 2017Congress - 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 theFox 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
“The positive results of eryaspase in second-line metastatic
pancreatic cancer have been highly significant for ERYTECH,”
commented
First Half and Recent Business Highlights
-
ERYTECH presented positive full Phase 2b data from its 141-patient
study evaluating eryaspase (GRASPA®) combined with chemotherapy in
second-line metastatic pancreatic cancer at ESMO 2017. The study met
its co-primary endpoints with respect to both overall survival (OS)
and progression-free survival (PFS) in the entire patient population.
Patients treated with eryaspase in combination with standard
chemotherapy had a 40% reduction of risk of death compared to patients
treated with chemotherapy alone (Hazard Ratio or HR of 0.60 (95% CI;
0.40, 0.88) (p=0.009). The HR for PFS was 0.59 (95% CI; 0.4, 0.89)
(p=0.011). In the study, there was consistent clinical benefit across
subgroups following treatment with eryaspase. The toxicity profile was
similar between the two treatment arms. A summary of the results can
be found in the press release issued last
Friday, September 8, 2017 . This data will also be discussed by the lead investigator for the study, Prof.Pascal Hammel , gastroenterologist-oncologist and head of oncology atBeaujon Hospital inParis , at a company-sponsored investor and analyst event held during the ESMO 2017. -
The positive Phase 2b results from ERYTECH’s metastatic pancreatic
cancer study form the basis for the company’s decision to pursue
further development in this disease. Next steps include the design of
a potential Phase 3 study in the U.S. and in
Europe , which ERYTECH expects to discuss with the U.S.FDA in the coming weeks and the CHMP before the end of the year. These results also provide the basis for ERYTECH’s decision to explore eryaspase as a treatment for other solid tumors, an area where non-encapsulated asparaginases have been investigated without success due to excessive toxicity. -
The clinical development of eryaspase (GRASPA®) in acute lymphoblastic
leukemia (ALL) and in acute myeloid leukemia (AML) is progressing:
-
ERYTECH is preparing its MAA resubmission to the CHMP for the
potential marketing authorization of GRASPA for the treatment of
relapsed or refractory ALL in
Europe , and intends to resubmit inOctober 2017 with supplemental data on comparability, immunogenicity and pharmacodynamics. - All patients in the third dose escalation cohort of ERYTECH’s US Phase 1 study in first-line adult ALL have been treated. A decision on the recommended Phase 2 dosing is expected in the coming weeks, which will enable ERYTECH to begin planning a pivotal Phase 3 study.
-
An investigator-initiated study to assess eryaspase in patients
with ALL was launched in Q2 of this year. The 30-patient, single
arm, multi-center Phase 2 study is being conducted in seven Nordic
and Baltic countries across 23 sites in collaboration with the
Nordic Society of Pediatric Hematology and Oncology (NOPHO) and aims to evaluate the pharmacokinetic and pharmacodynamic activity, safety and immunogenicity profile of eryaspase in combination with NOPHO’s 2008 multi-agent chemotherapy protocol for ALL, administered as second-intention treatment for children or adult ALL patients (1 to 45 years of age) who have experienced allergic or silent inactivation to PEG-asparaginase. The first patients were recently enrolled in this study. - ERYTECH’s ongoing Phase 2b study in elderly patients with newly diagnosed (AML) is on track for primary results by the end of this year.
-
ERYTECH is preparing its MAA resubmission to the CHMP for the
potential marketing authorization of GRASPA for the treatment of
relapsed or refractory ALL in
-
Promising preclinical data from multiple ERYCAPS pipeline programs
have been presented at medical meetings during 1H 2017:
- In January and April, ERYTECH presented preclinical data supporting its product candidate erymethionase, consisting of methionine-γ-lyase (MGL) encapsulated in red blood cells, as a potential effective strategy for targeting methionine-dependent cancers, at the 2017 ASCO GI Symposium and AACR Annual Meeting, respectively.
- In March, ERYTECH presented encouraging preclinical data supporting its immunotherapy program, ERYMMUNE, at two medical meetings, the World ADOPT Summit 2017 and the 10th Symposium of Vaccinology. In these studies, antigens encapsulated in modified red blood cells were able to delay tumor growth by inducing efficient and antigen-specific immune responses.
-
In September, ERYTECH presented promising preclinical data on its
eryminase and erymethionase programs at the 13th Annual
International Congress of Inborn Errors of Metabolism (ICIEM). The findings from the research on eryminase, consisting of arginine deiminase encapsulated in red blood cells, showed a decrease in arginine levels in a disease model of arginase-1 deficiency, supporting a potential treatment approach for hyperargininemia. This study was conducted in collaboration with Queen’s University (Kingston ,Canada ). In the study, administration of erymethionase resulted in lower homocysteine levels, supporting a potential treatment approach for homocystinuria. This study was conducted through a research collaboration with theFox Chase Cancer Center (FCCC ). Both collaborations underscore ERYTECH’s intent to expand the scope of its ERYCAPS platform technology beyond oncology in response to collaboration opportunities with companies active in the field of metabolic diseases and enzyme replacement therapies.
-
In April, ERYTECH raised €70.5 million in gross proceeds in a private
placement through the issuance of 3,000,000 new ordinary shares to
institutional investors in
the United States andEurope . ERYTECH continues to use the proceeds from this capital increase primarily to fund the further clinical development of its product candidates, including the launch of a prospective Phase 3 study in pancreatic cancer and evaluation of clinical development opportunities for eryaspase in other solid tumor indications. A portion of the proceeds will also be used for general corporate purposes, operational expenses and working capital. -
Over the past months, ERYTECH continued to strengthen its team,
especially in
the United States , through the appointments of:Naomi Eichenbaum as its Director of Investor Relations. Based inNew York , Naomi leads the development and implementation of ERYTECH’s investor relations strategy by communicating operational objectives, growth prospects and performance to the global investment community. Naomi has over 10 years of experience in life sciences and spent the last three years in investor relations at theTrout Group .Charles (Chuck) Monahan as its Senior Director of Regulatory Affairs. Chuck is a seasoned regulatory affairs executive with more than 15 years of experience at companies such asMillennium Pharmaceuticals ,AVEO Pharmaceuticals ,Transgene andEleven Biotherapeutics . Reporting to ERYTECH’s Chief Medical Officer, Chuck is in charge of the global regulatory affairs for ERYTECH.Dan Cole , Director of Strategic Marketing & Business Development. Dan brings 15 years of direct experience in oncology strategic marketing, market access and corporate development from working at companies such asSynta Pharmaceuticals ,Abraxis BioScience andLigand Pharmaceuticals . He provides strategic insight for the development and commercialization of ERYTECH’s pipeline programs and supports business development activities. He reports to Jean-Sébastien Cleiftie, ERYTECH’s Chief Business Officer, who relocated to the Company’sCambridge, MA office.- Florence Renart-Depontieu as Group Leader of Immuno-oncology.
Based in
Lyon, France , Florence develops and leads ERYTECH’s research programs in immunotherapy. Florence holds a Ph.D. in immunology, followed by a post-doctoral program, at theJohn Hopkins University (U.S.). Before ERYTECH, she worked for theLudwig Institute (Belgium ) and BliNK Biomedical.
Financial Highlights
ERYTECH’s key financial figures for the first six months of 2017, compared with the same period of the previous year, are summarized below:
Key figures (in thousands of euros):
1H (6 months) 2017 |
1H (6 months) 2016 |
Variation | ||||
Revenues | 0 | 0 | 0 | |||
Other income | 1,788 | 2,403 | (616) | |||
Total operating income | 1,788 | 2,403 | (616) | |||
Operating expenses: | ||||||
Research & development | (12,082) | (8,800) | (3,283) | |||
General & administrative | (3,895) | (4,222) | 327 | |||
Total operating expenses | (15,977) | (13,022) | (2,955) | |||
Operating loss | (14,189) | (10,618) | (3,571) | |||
Financial income | 114 | 260 | (146) | |||
Income tax | (5) | 9 | (14) | |||
Net Loss | (14,081) | (10,349) | (3,731) |
Net loss for the first half of 2017 was €14.1 million, compared to net
loss of €10.3 million for the same period of last year. The €3.7 million
increase reflected the continued efforts to advance ERYTECH’s
preclinical and clinical development programs. The increase was mostly
driven by higher service and contracting fees, related to the clinical
and regulatory progress of product development projects. Personnel costs
also increased in the 2017 period compared to 2016 following the
staffing of key additional positions in the preclinical and clinical
domains, to address the activity expansion both in
As of
Total cash and cash equivalents as of
The financial results for the first half of 2017 are in line with
ERYTECH’s expectations and strategy for 2017 which focus on advancing
the preclinical and clinical developments of its innovative treatments
for pancreatic cancer, ALL, AML and other solid tumors in
The financial report for the six months ending
Upcoming Milestones Expected over Next 12 Months
- Resubmission of EU MAA for GRASPA for the treatment of relapsed or refractory ALL
-
Meetings with
FDA and CHMP to discuss next steps for development of eryaspase in pancreatic cancer -
Maximum tolerated dose (MTD) defined in U.S. Phase 1 adult ALL study,
and meeting with
FDA on further ALL development plan - Results from EU Phase 2b AML study
- Potential launch of Phase 3 study in the U.S. and EU of eryaspase in pancreatic cancer
- Potential launch of Phase 3 study in first-line adult ALL
- Potential launch of Phase 1 study with erymethionase
First Half 2017 Conference Call Details
Investors and analysts wishing to participate can access the call via the following teleconferencing numbers:
France: +33 172001510 | Germany: +49 69222229031 | |||
USA: +1 6467224907 | Belgium: +32 24029640 | |||
UK: +44 2030432440 | Switzerland: +41 225809022 | |||
The Netherlands: +31 107138194 | Sweden: +46 850334664 | |||
Finland: +358 942599700 | Spain: +34 914142021 |
Confirmation Code: 54851684#
The webcast can be followed live online via the link:
http://www.anywhereconference.com?UserAudioMode=DATA&Name=&Conference=135310581&PIN=54851684
Following the live call, a replay will be available for 90 days. To listen to the replay, please dial:
France: +33(0)1 72 00 15 00 |
USA: +1 877 64 23018 |
UK: +44(0) 2033679460 |
Spain: +34 917896320 |
Confirmation Code: 310581#
Additionally, an archive of the webcast will be available on the “Webcast” section of the Company’s investor relations site.
Next Financial Updates:
-
Financial highlights for the 3rd quarter of 2017:
November 13, 2017 (after market close), followed by a conference call and webcast onNovember 14, 2017 (2:30pm CET /8:30am ET )
Upcoming Investor Conferences:
Morgan Stanley Global Healthcare Conference ,September 13 ,New York Jefferies Global Healthcare Conference ,November 15-16 ,London -
Actionaria,
November 23-24 ,Paris ODDO BHF Forum ,January 11-12, 2018 ,Lyon -
Investor access event at the
J.P. Morgan Healthcare Conference ,January 8-11, 2018 ,San Francisco
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 multiagent chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), but side effects limit treatment, 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.
Eryaspase achieved positive efficacy and safety results in a Phase 2
study in elderly patients with ALL, and a Phase 2/3 study in children
and adults with relapsed or refractory ALL. ERYTECH believes that the
positive results of its Phase 2b clinical study in second-line
metastatic pancreatic cancer are significant indicators of eryaspase as
a potential treatment approach in solid tumors. ERYTECH also has an
ongoing Phase 1 clinical study of eryaspase in
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
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20170911005698/en/
Source:
ERYTECH
Naomi Eichenbaum, +1 917 312 5151
Director
of Investor Relations
naomi.eichenbaum@erytech.com
or
The
Ruth Group
Lee Roth, +1 646 536 7012
Investor
relations
lroth@theruthgroup.com
or
Kirsten
Thomas, +1 508 280 6592
Media relations
kthomas@theruthgroup.com
or
NewCap
Julien
Perez
Investor relations
Nicolas Merigeau
Media
relations
+33 1 44 71 98 52
erytech@newcap.eu