ERYTECH Reports First Quarter 2018 Financial Results and Provides Business Update
Conference call and webcast scheduled for
at
- Finalized Phase 3 trial design for eryaspase in second line pancreatic cancer; on track for expected start of patient enrollment in Q3
- Selected triple-negative breast cancer as the next solid tumor indication; preparing Phase 2 trial with expected start of patient enrollment in Q3
- Reported positive U.S. Phase 1 trial results in adult acute
lymphoblastic leukemia; discussion with
FDA upcoming - Cash position of €171.8 million (
$211.6 million ) as ofMarch 31, 2018
“Following our successful Nasdaq listing at the end of last year, the
first quarter of this year has been focused on the execution of the plan
to advance our pipeline into solid tumor indications,” said
Business Highlights
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Feedback was obtained from the
Commission for Human Medicinal Products (CHMP) of theEuropean Medicines Agency (EMA) on the design of the proposed Phase 3 trial with eryaspase in second line pancreatic cancer, confirming earlier feedback by theU.S. Food and Drug Administration (FDA ). The proposed Phase 3 trial will evaluate eryaspase in combination with standard chemotherapy, compared to standard chemotherapy alone, in approximately 500 patients inthe United States andEurope . The primary endpoint will be overall survival (OS). An interim analysis is foreseen when approximately two-thirds of events have occurred. Set up activities for this pivotal Phase 3 clinical trial are ongoing. Enrollment of the first patient is expected in the third quarter of 2018. -
Metastatic triple-negative breast cancer (TNBC) was selected as the
next solid tumor indication for the development of eryaspase. TNBC is
an aggressive and metabolically active form of breast cancer for which
limited treatment options are available. The planned proof of concept
Phase 2 trial will evaluate eryaspase in combination with standard
chemotherapy, compared to standard chemotherapy alone, in
approximately 60 previously untreated patients in
Europe andthe United States . An interim analysis is foreseen. The primary endpoint will be objective response rate. Set up activities are ongoing and start of patient enrollment is expected in the third quarter of 2018. - ERYTECH is planning to expand the clinical development of eryaspase to first-line pancreatic cancer, as well as to other solid tumor indications. Program updates are expected later in 2018 and early 2019.
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Full results from the U.S. Phase 1 trial evaluating eryaspase in
combination with chemotherapy for the treatment of first line adult
ALL were presented at the annual meeting of the
American Association for Cancer Research (AACR). The data showed eryaspase was well tolerated. Based on the pharmaco-kinetic data and the safety findings, the recommended dose for further clinical development was determined to be 100 U/kg. A meeting with theFDA to discuss the next steps in ALL inthe United States is upcoming, based on which we expect to be able to provide feedback during the third quarter of 2018. - Additionally, the Company also presented pre-clinical data on the combination of eryaspase and erymethionase, methionine-gamma-lyase encapsulated in red blood cells. The data in this study suggested that this combination could be promising in vitro and in vivo in a gastric cancer model with tumor growth inhibition in-vivo and decreased tumor cell viability in vitro.
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Earlier today, the Company announced the expansion of its executive
management team with the addition of
Alex Dusek as VP of Commercial Strategy, to lay the groundwork for commercial success and ensure commercial product preparedness, primarily in the U.S. He brings over 25 years of experience including commercial strategic roles atArgos Therapeutics , Bayer, andUnited Therapeutics .
Financial Highlights
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Net loss for the three-month period ended
March 31, 2018 was €11.7 million, compared to €6.5 million in the same period of 2017. The €5.2 million increase was primarily attributable to:- An increase in R&D expenses by €1.9 million, related to the Company’s intensified clinical and regulatory activities, as well as the additional staffing for preclinical research and clinical development.
- An increase in G&A expenses by €0.8 million, resulting from continued infrastructure developments in line with the Company’s growth.
- The accounting of a €2.5 million financial loss, as the Company’s cash position denominated in euros was impacted by the negative currency exchange variation in the period of the U.S. dollar against the euro.
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As of
March 31, 2018 , ERYTECH had cash and cash equivalents totaling €171.8 million, compared with €185.5 million as ofDecember 31, 2017 . The €13.8 million decrease in total cash and cash equivalents in the three-month period comprised a total net cash utilization of €11.2 million for operating, investing and financing activities, and a €2.6 million negative foreign exchange impact on the Company’s cash position denominated in U.S. dollars. This financial accounting loss had no real cash impact, as the U.S. dollar position is kept in that currency for U.S. dollar disbursements.
Key Upcoming Milestones Expected in 2018
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Meeting with the
FDA to discuss next steps in ALL -
Launch of a pivotal Phase 3 clinical trial in second-line pancreatic
cancer in
Europe andthe United States - Launch of a Phase 2 proof-of-concept clinical trial in TNBC
- CHMP opinion on MAA resubmission for GRASPA® in R/R ALL
- Initiation of a Phase 2 proof-of-concept clinical trial in first-line pancreatic cancer
- Initiation of Phase 1 clinical trial with erymethionase
First Quarter Results 2018 Conference Call Details
As a reminder, ERYTECH management will hold a conference call and
webcast on
The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 3498017# |
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USA/Canada: +1 833 818 6807 |
United-Kingdom: +44 2031070289 |
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Switzerland: +41 445802606 |
Germany: +49 6922224728 |
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France: +33 176748988 |
Belgium: +32 24003547 |
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Sweden: +46 856619361 |
Finland: +358 972519310 |
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Netherlands: +31 207075547 |
Spain: +34 914142503 |
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The webcast can be followed live online via the link: https://edge.media-server.com/m6/p/wq3dzxoy
An archived replay of the call will be available for 7 days by dialing + 1 800 585 8367, Conference ID: 3498017#
An archive of the webcast will be available on ERYTECH’s website, under the “Investors” section at investors.erytech.com
2018 Financial Calendar:
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General Assembly Meeting of Shareholders:
Friday, June 22, 2018 at10:00am CET inParis -
Quarterly financial updates:
-
Business Update and Financial Highlights for the 2nd quarter and
first-half of 2018:
September 17, 2018 (after U.S. market close), followed by a conference call and webcast onSeptember 18, 2018 (2:30pm CET /8:30am ET ) -
Business Update and Financial Highlights for the 3rd quarter of
2018:
November 12, 2018 (after U.S. market close), followed by a conference call and webcast onNovember 13, 2018 (2:30pm CET /8:30am ET )
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Business Update and Financial Highlights for the 2nd quarter and
first-half of 2018:
Upcoming Investor Conferences:
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BioEquity Europe 2018,
May 16 , Ghent -
Gilbert Dupont Annual Healthcare Conference,
May 29 ,Paris Jefferies 2018 Global Healthcare Conference,June 5-6 ,New York -
Journée Valeurs Moyennes SFAF,
June 20 ,Paris JMP Life Sciences Conference ,June 20 ,New York -
European Midcap Event – Spring,
June 26-27 ,Paris
About ERYTECH: www.erytech.com
Founded in Lyon, France in 2004, ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, which uses a novel technology to encapsulate therapeutic drug substances inside red blood cells, ERYTECH has developed a pipeline of product candidates targeting markets with high unmet medical needs. ERYTECH’s initial focus is on the development of products that target the altered amino acid metabolism of cancer cells, depriving them of nutrients necessary for their survival.
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 pediatric acute lymphoblastic leukemia (ALL), but side effects limit treatment compliance, especially in adults and patients with weak performance status.
Eryaspase demonstrated positive efficacy and safety results in various clinical trials in ALL, including in a Phase 2 study in patients over 55 years of age and in a Phase 2/3 trial in relapsed or refractory ALL patients, as well as in pancreatic cancer, where it achieved positive results in a Phase 2b trial of second-line treatment of patients with metastatic pancreatic cancer. ERYTECH is preparing for the launch of a pivotal Phase 3 clinical trial in second line pancreatic cancer and Phase 2 trials in first line pancreatic cancer and triple-negative breast cancer.
ERYTECH produces eryaspase at its own GMP-approved and operational
manufacturing site in Lyon (
In addition to eryaspase, ERYTECH is developing erymethionase, methionine-γ-lyase encapsulated in red blood cells, to target cancer cells’ amino acid 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 the Nasdaq Global Select Market in the
Forward-looking information
This press release contains forward-looking statements, forecasts and
estimates with respect to the clinical results from and the development
plans of eryaspase, 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. All statements
contained in this press release other than statements of historical
facts are forward-looking statements, including, without limitation,
statements regarding the potential of ERYTECH’s product pipeline, its
clinical development and regulatory plans for eryaspase, the timing of
ERYTECH’s clinical studies and trials and announcements of data from
those studies and trials, and the contents and timing of decisions by
the
View source version on businesswire.com: https://www.businesswire.com/news/home/20180514006177/en/
Source:
ERYTECH
Naomi Eichenbaum
Director Investor
Relations
+33 4 78 74 44 38
+1 917 312 5151
naomi.eichenbaum@erytech.com
or
NewCap
Julien
Perez
Investor relations
Nicolas Merigeau
Media
relations
+33 1 44 71 98 52
ERYTECH@newcap.eu