ERYTECH Highlights 2021 Milestones and Provides Update on Cash Position

ERYTECH Highlights 2021 Milestones
and Provides Update on Cash Position
                                                       

 

• Strong execution and achievement of key milestones in challenging year 2020
• Four clinical programs with lead product candidate eryaspase expected to report results and/or regulatory milestones in 2021:
  • TRYBeCA-1, Phase 3 in 2L advanced pancreatic cancer, expected to report top-line results, potentially at interim analysis in Q1, or at final analysis, in Q4
  • FDA feedback on potential path to approval in hypersensitive ALL, based on positive Phase 2 investigator sponsored trial (IST), expected in 1H
  • TRYbeCA-2, Phase 2 in triple-negative breast cancer, expected to report top-line results in Q4
  • Determination of the maximum tolerated dose (MTD) in rESPECT trial, Phase 1 IST in 1L advanced pancreatic cancer, expected by the end of the year
• Cash and cash equivalents of €44.4 million¹ ($54.4 million) at the end of December 2020
  
  

Lyon (France) and Cambridge, MA (U.S.), 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, today provided an update on main achievements in 2020 and key expected milestones for 2021, and reported its end of year 2020 cash position.

“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