BioLineRx (NASDAQ: BLRX) reported Q1 EPS of ($0.04), $0.62 better than the analyst estimate of ($0.66).

Highlights and achievements during the first quarter 2020 and subsequent period:

• Completed recruitment of the triple combination arm of the COMBAT/KEYNOTE-202 study;
• Continued to advance the COMBAT/KEYNOTE-202 study toward progression free survival (PFS) and overall survival (OS) data in mid-2020;
• Received Orphan Drug Designation for motixafortide (BL-8040) for the Treatment of Pancreatic Cancer in Europe;
• Announced Notice of Allowance from USPTO for a broad patent covering motixafortide in combination with anti-PD-1 for the treatment of any and all types of cancer.

"The ongoing COVID-19 pandemic has caused an unprecedented disruption in business activities and continues to impact drug development timelines around the world," stated Philip Serlin, Chief Executive Officer of BioLineRx. "During this crisis, we have remained in close contact with our principal investigators, and we remain on track to report important survival data from the triple combination arm of our ongoing Phase 2a COMBAT/KEYNOTE-202 study in advanced second-line pancreatic cancer mid-year, consistent with our prior guidance. The compelling and sustained preliminary response data on 22 evaluable patients that we reported in December give us hope that the combination of motixafortide, KEYTRUDA® and chemotherapy could represent a significant breakthrough in one of the most difficult to treat cancers."

"We also continue to expect results from our ongoing BLAST Phase 2b study of motixafortide in consolidation therapy for AML patients and our GENESIS Phase 3 trial in stem cell mobilization for autologous transplantation in multiple myeloma patients by the end of this year."

"Development of our second clinical candidate, AGI-134, has been impacted by COVID-19, as enrollment in the Phase 1/2a trial has been temporarily suspended. We now expect data from that study in the second half of next year."

"We have taken swift actions in response to the pandemic to conserve cash and ensure that we can successfully navigate through this unprecedented time. But we remain as enthusiastic as ever about the broad therapeutic potential of motixafortide to treat a broad range of cancers, and we look forward to three important data readouts this year," Mr. Serlin concluded.

Upcoming 2020 and 2021 Milestones

• Progression-free survival and overall survival data from the triple combination arm of the COMBAT/KEYNOTE-202 Phase 2a study in mid-2020;
• Interim results from the BLAST Phase 2b AML consolidation study in the second half of 2020;
• Results from the GENESIS Phase 3 registrational study in stem cell mobilization in the second half of 2020;
• Initial results from Part 2 of Phase 1/2a trial of AGI-134, which were initially expected by year-end 2020, are now anticipated in the second half of 2021 due to a temporary suspension of recruitment caused by the COVID-19 pandemic.

For earnings history and earnings-related data on BioLineRx (BLRX) click here.