ERYTECH Provides Business Update and Reports Financial Results for Full Year 2016
Conference call and webcast on
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Activities for resubmission of European Marketing Authorization
Application (MAA) for eryaspase (GRASPA) in relapsed and refractory
acute lymphoblastic leukemia (ALL)ongoing after withdrawal in
November 2016 ; resubmission targeted in Q3 2017 - Patient enrollment completed in Phase 2 study of eryaspase in pancreatic cancer; top-line results expected end Q1 2017
- Patient enrollment completed in Phase 2b study of eryaspase in acute myeloid leukemia (AML); results expected in Q4 2017
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Promising new data with erymethionase (ERY-MET) presented at
ASCO GI inJanuary 2017 - Board and executive management strengthened
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€10 million raised through a private placement in
December 2016 -
Cash position of €37.7 million at year-end
“In 2016, we made important progress moving our pipeline forward
despite our decision to withdraw and resubmit our European Marketing
Authorization Application for GRASPA. We are committed to bringing
GRASPA to the market and continue to make significant strides in
pursuing its first regulatory approval,” said
Full Year and Recent Business Highlights
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In
November 2016 , ERYTECH withdrew its Marketing Authorization Application (MAA) for eryaspase (GRASPA) for the treatment of relapsed and refractory ALL. The Company recognized that the time allowed in the CHMP procedure was not adequate to provide the additional data needed to answer the remaining questions in the CHMP’s Day 180 List of Outstanding Issues (LOI). The company is working toward collecting the data regarding comparability between the old and new forms of asparaginase encapsulated in GRASPA and the development of a new immunogenicity assay, as well as the pharmacodynamics effects of eryaspase. ERYTECH expects to resubmit the MAA this summer. The re-submission process has been initiated and interactions with the EMA and CHMP are being organized. -
The US Phase 1 dose-escalating study of eryaspase in first line adult
ALL is progressing and is now expected to reach its recommended Phase
2 dose in mid-2017, after which the company intends to discuss further
development plans with the
FDA . -
The company is continuing to provide access to eryaspase under its
expanded access program (EAP) in
France , treating patients who cannot tolerate any of the available asparaginase products. Some patients have also been treated on a compassionate use basis, both inEurope and the US. The Company is also discussing with several investigators the potential for conducting investigator-initiated studies as a means to provide eryaspase to patients suffering from ALL. - During the third quarter of 2016, complete enrollment was reached in the Phase 2b study with eryaspase in first line AML patients and in the Phase 2 study of eryaspase in second line metastatic pancreatic cancer. Respectively 123 and 141 patients have been treated. Reporting of the primary results of the pancreatic cancer study is expected by the end of Q1 2017. Results of the AML study are expected by the end of the year.
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In
January 2017 , ERYTECH presented findings from preclinical studies demonstrating strong tumor inhibiting activity of its new product candidate erymethionase (or ERY-MET) in a murine model of human gastric adenocarcinoma. Previous studies had also demonstrated erymethionase as a tumor starvation agent in glioblastoma mouse models. - Preclinical development programs leveraging the use of the ERYCAPS encapsulation technology in immuno-oncology (ERYMMUNE) and enzyme therapies for certain metabolic diseases (ERYZYME) are progressing. Further proof of concept data is expected in the second half of this year.
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During 2016, the Company strengthened its board of directors and its
executive management through the appointments of
Allene Diaz as an independent board member,Alexander Scheer as Chief Scientific Officer (CSO) and Jean-Sébastien Cleiftie as Chief Business Officer (CBO). All three bring tremendous experience in the biopharmaceuticals field.Allene Diaz currently serves as Senior Vice President, Global Commercial Development atTESARO Inc. after having served for more than 20 years in senior executive functions at Merck Serono, EMD Serono,Amylin Pharmaceuticals ,Cancervax Corporation , Biogen Idec,Pfizer and Parke-Davis Pharmaceuticals . Alexander was the Head of Research atPierre Fabre , and Jean-Sébastien Cleiftie was Associate Vice-President,Global Business Development & Licensing atSanofi before joining ERYTECH.
Full Year 2016 Financial Results
- ERYTECH’s key financial figures for the full year of 2016 compared with the same period of the previous year are summarized below:
In thousands of euro | FY 2016 | FY 2015 | ||
Revenues | 0 | 0 | ||
Other income | 4,138 | 2,929 | ||
Total operating income | 4,138 | 2,929 | ||
Operating expenses: | ||||
Research & development | (19,813) | (10,776) | ||
General & administrative | (6,861) | (7,736) | ||
Total operating expenses | (26,674) | (18,512) | ||
Operating loss | (22,537) | (15,583) | ||
Financial income | 482 | 567 | ||
Income tax | 42 | 3 | ||
Net Loss | (22,012) | (15,013) |
Net loss for the full year 2016 was €22.0 million, compared to €15.0
million in 2015. The €7.0 million increase was primarily due to the €8.2
million increase in operating expenses, primarily due to the increase in
clinical and regulatory development expenses, related to ongoing
clinical programs in ALL, AML and Pancreatic cancer, the continuation of
regulatory developments in
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R&D expenses increased by €9.0 million. The increase was primarily the
result of a €8.0 million increase in consumables and third-party
services related to pre-clinical programs and clinical trials
conducted in 2016 and a €1.4 million increase in personnel expenses
due to increasing headcount, including staffing of the company’s new
U.S. office in
Boston . - G&A expenses decreased by €0.9 million. The decrease was mainly related to a €1.6 million decrease in share-based payments, while personnel expenses increased by €1.1 million and travel-related expenses increased by €0.4 million, a reflection of the broader international base of the company’s operations.
- The increase in expenses was partially offset by the €1.2 million increase in operating income, related to higher French research tax credits of €1.1 million, which reflected the increased effort in R&D activities, as well as a €0.1 million increase in non-refundable grants from Bpifrance for the TEDAC program.
- Financial income decreased by €0.1 million, mostly as a result of lower average interest rates on interest-bearing investments.
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In
December 2016 , ERYTECH completed a €10.0 million private placement with a group of qualified investors in the Unites States andEurope . 793,877 ordinary shares were issued in the private placement. The proceeds from the private placement will enable ERYTECH to further advance several key strategic initiatives related to the development of its lead product candidate, eryaspase (GRASPA®), as well as for working capital and general corporate purposes. -
As of
December 31, 2016 , ERYTECH had cash and cash equivalents totaling €37.7 million, compared with €45.6 million onDecember 31, 2015 . Net cash utilization for the 12-month period endedDecember 31, 2016 was €8.0 million and included the €9.2 million net proceeds from the Company’sDecember 2016 private placement of ordinary shares. Excluding theDecember 2016 capital raise, total cash utilization in 2016 was €17.2 million, comprised of a €19.3 million net cash utilization in operating activities and capital expenditures, as a result of ERYTECH’s continued efforts to advance its research and development programs, as well as increased general and administrative expenses, and a €2.1 million increase in borrowings, including a €1.5 million bank loan to support the design of the next generation ERYCAPS platform and a €0.6 million net increase in conditional advances from Bpifrance. -
As of
December 31, 2016 , ERYTECH’s cash position of €37.7 million represented approximately a two-year cash runway with the current company’s structure and ongoing studies.
The consolidated financial accounts for the full year 2016, approved by
the board of directors on
Key newsflow and milestones expected over next 12 months
- Results from Phase 2 pancreatic cancer study
- MTD defined in US Phase 1 adult ALL study
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Meeting with
FDA on further ALL development plan - Resubmission of EU marketing authorization application for GRASPA in R/R ALL
- Launch of erymethionase Phase 1 study
- Preclinical proof of concept data with ERYMMUNE and ERYZYME programs
- Results from EU Phase 2b AML study
Full Year results 2016 Conference Call Details
As a reminder, ERYTECH management will hold a conference call and
webcast on
Investors and analysts wishing to participate can access the call via the following teleconferencing numbers:
USA: +1 6467224907 | 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 |
Confirmation Code: 35823698#
The webcast can be followed live online via the link:
http://www.anywhereconference.com?UserAudioMode=DATA&Name=&Conference=135307282&PIN=35823698
Following the live call, a replay will be available for 90 days. To listen to the replay, please dial:
USA: +1 877 64 230 18 |
United-Kingdom: +44(0) 2033679460 |
France: +33(0)1 72 00 15 00 |
Confirmation Code: 307282#
Additionally, an archive of the webcast will be available on the “Webcast” section of the Company’s investor relations site at www.erytech.com
Next financial updates:
Business Update and Financial Highlights for the 1st quarter
of 2017:
Upcoming participations at investor conferences:
-
Cowen Annual Healthcare Conference,
March 6-8 ,Boston -
European SmallCap Event,
April 18 ,Paris -
Kempen Healthcare & Life Sciences Conference ,April 19 ,Amsterdam -
Euronext andOddo Tech40 Investor Forum ,April 27 ,Frankfurt -
BioEquity Europe 2017,
May 22-23 ,Paris -
Gilbert Dupont Annual Healthcare Conference,
May 30 ,Paris -
Jefferies 2017 Global Healthcare Conference,June 6-9 ,New-York -
European MidCap Spring Event,
June 28 ,Paris
About ERYTECH: www.erytech.com
Founded in
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
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
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/20170302006094/en/
Source: ERYTECH
ERYTECH
Gil Beyen
Chairman and CEO
or
Eric
Soyer
CFO and COO
+33 4 78 74 44 38
investors@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
Julien
Perez
Investor relations
or
Nicolas Merigeau
Media
relations
+33 1 44 71 98 52
erytech@newcap.eu