On November 7, 2019 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported its financial results for the quarter ended September 30, 2019 (Press release, ERYtech Pharma, NOV 7, 2019, View Source [SID1234550750]).
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"Our lead program, TRYbeCA1, the Phase 3 trial in pancreatic cancer, is progressing on plan and recently reached two important milestones," said Gil Beyen, CEO of ERYTECH. "A planned safety review by an independent data monitoring committee of the first 150 patients in the study revealed no safety concerns, and the study was opened for patient enrollment in the United States. Our new production facility in Princeton is ready to produce the batches for the U.S. patients in the trial."
Recent Business Highlights
Patient enrollment is on track in TRYbeCA1, the pivotal Phase 3 trial evaluating ERYTECH’s lead product candidate eryaspase in second-line metastatic pancreatic cancer. Clinical trial authorizations have been obtained in all twelve participating countries, eleven countries in Europe plus the United States, and the trial is actively enrolling patients in close to 50 clinical sites in Europe.
TRYbeCA1 was opened for patient enrollment in the United States last week, and the first of a total of approximately 30 planned U.S. sites were activated.
The newly established U.S. manufacturing facility in Princeton, N.J. is ready to produce clinical batches, and will supply eryaspase for the U.S. patients in the TRYbeCA1 trial.
Separately, also last week, the independent data monitoring committee (IDMC) reviewed the safety data of the first 150 patients enrolled and treated in the TRYbeCA1 trials. No safety issues were identified and the IDMC recommended to continue the trial as planned.
Q3 2019 Financial Results
Key financial figures for the first nine months of 2019 compared with the same period of the previous year are summarized below:
Net loss for the first nine months of 2019 was €43.3 million, up €13.6 million (+46%) as compared to the same period in 2018, with a €13.2 million increase (+39%) in operating loss and a €0.4 million decrease in financial income. The €13.2 million increase in operating loss was attributable to the €11.3 million increase in preclinical and clinical development expenses, mostly related to expenses incurred related to the Company’s Phase 3 clinical trial in pancreatic cancer, the €3.2 million increase in G&A expenses, of which €1.9 million related to the launch readiness of the Company’s additional manufacturing capacity, and the €1.2 million increase in operating income, of which €0.9 million upfront payment from the license agreement with SQZ Biotechnologies.
As of September 30, 2019, ERYTECH had cash and cash equivalents totaling €81.9 million (approximately $89.2 million), compared with €134.4 million on December 31, 2018 and €94.5 million at the end of June 2019. The €52.4 million decrease in cash position in the first nine months of 2019 was the result of a €55.6 million net cash utilization, comprised of a €36.7 million net cash utilization in operating activities, €19.3 million used for investing activities and €0.4 million of cash generation in financing activities, while the appreciation in the period of the U.S. dollar against the euro led to a €3.2 million favorable currency exchange impact. After a peak in capital expenditure disbursements in the first quarter of 2019 related to the expansion of the manufacturing facilities in Lyon and in Princeton, cash utilization has slowed in the second and third quarter. The Company’s cash position at the end of September remains in line with the earlier guidance of sufficient cash resources to fund operations until the end of 2020.
Key News Flow and Milestones Expected Over the Next 12 Months
First U.S. patients randomized in TRYbeCA1, the Phase 3 clinical trial in second-line metastatic pancreatic cancer (Q4 2019)
Initiation of investigator sponsored Phase 1 trial in first-line metastatic pancreatic cancer (H1 2020)
Interim results of investigator sponsored Phase 2 trial in second-line acute lymphoblastic leukemia(H1 2020)
Interim (superiority) analysis in TRYbeCA1 (Q3 2020)
Q3 2019 Conference Call Details
ERYTECH management will hold a conference call and webcast on Friday, November 8th, 2019 at 02:30pm CET / 08:30am ET on the business highlights and financial results for the third quarter of 2019. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.
The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 7394954#
USA/Canada: +1 (833) 818-6807
France: +33 1 70 80 71 53
International Dial-In Number: +1 (409) 350-3501
United-Kingdom: +44 2031070289
The webcast can be followed live online via the link: View Source
An archived replay of the call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 7394954#.
An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com
Financial Calendar
Next quarterly financial updates:
Business Update and Financial Highlights for the 4th Quarter and Full Year of 2019: March 16, 2020 (after U.S. market close), followed by a conference call and webcast on March 17, 2020 (2:30pm CET/8:30am ET)
Business Update and Financial Highlights for the 1st Quarter of 2020: May 6, 2020 (after U.S. market close), followed by a conference call and webcast on May 7, 2020 (2:30pm CET/8:30am ET)
Business Update and Financial Highlights for the 2nd Quarter of 2020: September 21, 2020 (after U.S. market close), followed by a conference call and webcast on September 22, 2020 (2:30pm CET/8:30am ET)
Business Update and Financial Highlights for the 3rd Quarter of 2020: November 5, 2020 (after U.S. market close), followed by a conference call and webcast on November 6, 2020 (2:30pm CET/8:30am ET)
ERYTECH will Present at the Following Upcoming Investor Conferences:
Jefferies Healthcare Conference, November 20-21, London
◾Salon Actionaria, November 22, Paris
ODDO Investor Conference, January 9, Lyon
LifeSci Advisors Corporate Access Event, January 13-14, San Francisco
About TRYbeCA1
TRYbeCA1 is a randomized, controlled Phase 3 clinical trial evaluating eryaspase in second-line metastatic pancreatic cancer. The trial is planned to enroll approximately 500 patients at approximately 100 clinical sites in Europe and the United States. Eligible patients are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab-paclitaxel or an irinotecan-based regimen) or chemotherapy alone. The primary endpoint of TRYbeCA1 is overall survival. An interim superiority analysis will be conducted when approximately two-thirds of the events will have occurred.