On January 25, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported an update on main achievements in 2020 and key expected milestones for 2021, and its end of year 2020 cash position (Press release, ERYtech Pharma, JAN 25, 2021, View Source [SID1234574340]).
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"ERYTECH is entering 2021 with great expectations on its full scope of activities," said Gil Beyen, CEO of ERYTECH Pharma. "After more than three years of dedicated operational execution on the pipeline of development projects, 2021 is expected to bring results in all four of ERYTECH’s clinical programs, with a potential for market authorization filings in two indications with high unmet medical need."
Key 2020 Achievements and Expected 2021 Milestones
TRYbeCA-1, pivotal Phase 3 clinical trial in second-line metastatic pancreatic cancer
Fast Track designation granted in April 2020
Enrollment completed in December 2020; 512 patients enrolled, 6% above enrollment target of 482 patients
On track for interim superiority analysis in Q1 2021 with two possible outcomes:
Trial can conclude early for superiority if compelling improvement of overall survival demonstrated
Trial to continue as planned with final analysis expected to report in Q4 2021
If trial concludes at interim, filings for approval in the United States and in Europe targeted by year end 2021
NOPHO-sponsored Phase 2 trial in acute lymphoblastic leukemia
Enrollment completed in August 2020
Positive results presented at the ASH (Free ASH Whitepaper) Annual Meeting in December 2020
Ongoing dialogue with FDA to explore path to approval based on positive Phase 2 results; FDA feedback expected in 1H 2021
In case of a path to approval, BLA filing expected in 2021
TRYbeCA-2, Phase 2 clinical trial in triple-negative breast cancer
Trial enrolling patients in three countries in Europe
Top-line results expected in Q4 2021
rESPECT, Phase 1 investigator-sponsored trial (Georgetown University) in first-line metastatic pancreatic cancer
Trial initiated in Q4 2020. First patient enrolled
Determination of maximum tolerated dose expected by end of 2021
2020 Year-End Cash and Guidance
As of December 31, 2020, ERYTECH had cash and cash equivalents totaling €44.4 million (approximately $54.4 million), compared with €73.2 million on December 31, 2019. The €28.8 million decrease in cash position during the twelve months of 2020 resulted mostly from a net cash utilization of €56.3 million and financings totalling €27.5 million and including:
The draw down of five tranches of €3 million each under the convertible bond financing agreement with Alpha Blue Ocean, for net proceeds of €14.2 million. All five tranches have already been converted and have resulted in the issuance of 2,430,925 new shares, representing 13% of the Company’s outstanding share capital to date.
€10 million non-dilutive, state-guaranteed PGE loan from Bpifrance and Société Générale, and €3.3 million in loan and grant milestone payments from Bpifrance on the preclinical R&D Tedac project.
The above information is based on preliminary unaudited financial results as of December 31, 2020. Fourth Quarter and Full-Year 2020 financial results will be disclosed on March 8, 2021.
§ The Company believes that its cash position and cash equivalents as of December 31, 2020 can fund its planned operating expenses and current programs into the third quarter of 2021, and together with the remaining option of potential proceeds available under the convertible bonds financing and its ATM program, until the end of 2021.
Financial Calendar 2021
Business Update and Financial Highlights for the Fourth Quarter and Full Year 2020: March 8, 2021 (after U.S. market close), followed by a conference call & webcast on March 9, 2021 (2:30pm CET/8:30am ET)
Business Update and Financial Highlights for the First Quarter of 2021: May 4, 2021 (after U.S. market close), followed by a conference call & webcast on May 5, 2021 (2:30pm CET/8:30am ET)
Business Update and Financial Highlights for the Second Quarter of 2021: September 20, 2021 (after U.S. market close), followed by a conference call & webcast on September 21, 2021 (2:30pm CET/8:30am ET)
Business Update and Financial Highlights for the Third Quarter of 2021: November 15, 2021 (after U.S. market close), followed by a conference call & webcast on November 16, 2021 (2:30pm CET/8:30am ET)