BioLineRx Ltd. develops oncology and rare-disease therapies, with recurring updates centered on GLIX1, APHEXDA (motixafortide), and motixafortide development in solid tumors.
Company news covers GLIX1 clinical development for glioblastoma and other solid tumors under its Hemispherian collaboration, intellectual-property developments tied to GLIX1, financial results, and corporate updates. APHEXDA is approved in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma and is commercialized by partners, while BioLineRx has retained motixafortide rights for solid-tumor programs including metastatic pancreatic cancer.
BioLineRx Ltd. (NASDAQ: BLRX) announced an underwriting agreement with H.C. Wainwright & Co. for the purchase of 4,166,667 American Depositary Shares (ADSs) at $2.40 each. The offering is expected to close around January 22, 2021, with gross proceeds estimated at $10 million. The funds will be utilized for general corporate purposes, including funding clinical trials. The underwriter also holds a 30-day option to purchase an additional 625,000 ADSs. This offering follows a recently effective shelf registration statement filed with the SEC.
BioLineRx reported results from the COMBAT/KEYNOTE-202 study on motixafortide (BL-8040) for stage IV pancreatic cancer, showing significant efficacy improvements over historical data. The study involved 43 patients, yielding a median overall survival of 6.5 months (vs. 4.7 months historical) and a confirmed overall response rate of 13.2% (vs. 7.7% historical). The combination was well-tolerated with safety advantages noted, including lower instances of grade 3 neutropenia and infections. The results underscore the potential of motixafortide in improving treatment outcomes for pancreatic ductal adenocarcinoma patients.
BioLineRx Ltd. (NASDAQ: BLRX) reported its Q3 2020 financial results, highlighting significant clinical advancements, including a positive interim analysis from the GENESIS Phase 3 trial of motixafortide for stem cell mobilization in multiple myeloma, resulting in a recommendation to cease enrollment at 122 patients. R&D expenses decreased to $3.5 million, a reduction of $2.1 million year-over-year. The net loss for Q3 2020 was $4.6 million, compared to $3.9 million in 2019. BioLineRx held $20.8 million in cash and equivalents as of September 30, 2020.
BioLineRx Ltd. (NASDAQ: BLRX), a clinical-stage biopharmaceutical company specializing in oncology, will announce its unaudited financial results for the quarter ending September 30, 2020, on November 23, 2020, before US markets open. The company will host a conference call at 10:00 a.m. EST on the same day, featuring remarks from CEO Philip Serlin. Interested parties can listen via the Investor Relations page. BioLineRx is leading developments in cancer therapies, including Motixafortide and AGI-134.
BioLineRx Ltd. (NASDAQ: BLRX) has announced a Phase 1b clinical trial of its lead drug candidate, Motixafortide, aimed at treating acute respiratory distress syndrome (ARDS) related to COVID-19 and other viral infections. The study, led by Dr. Yasmin Maor at Wolfson Medical Center, will enroll up to 25 patients, assessing safety and exploratory respiratory parameters. Preliminary results are expected in the first half of 2021. The company also plans to share full data from its Phase 2a pancreatic cancer study and interim results from its AML study by the end of 2020.
BioLineRx Ltd. (NASDAQ: BLRX) announced positive results from an interim analysis of the ongoing GENESIS Phase 3 trial for motixafortide, which targets stem cell mobilization in multiple myeloma patients. The independent Data Monitoring Committee recommended halting patient enrollment after identifying statistically significant evidence favoring motixafortide treatment, concluding at 122 patients instead of the planned 177. The final results are expected in 2021, aiming to establish motixafortide as the new standard of care alongside G-CSF.
BioLineRx Ltd. (NASDAQ: BLRX) announced the initiation of a Phase 2 clinical trial for Motixafortide, a CXCR4-inhibitor, in combination with cemiplimab and standard chemotherapy for first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC). The study, led by Columbia University, aims to enroll 40 patients, assessing overall response rate (ORR) and other secondary outcomes. Data is expected in mid-2022. This approach targets a significant unmet need in pancreatic cancer treatment, given the low response rates of current therapies.
BioLineRx Ltd. (NASDAQ: BLRX) announced that approximately 65% of patients have been enrolled in the GENESIS Phase 3 trial for motixafortide (BL-8040) aimed at mobilizing hematopoietic stem cells for multiple myeloma autologous transplantation. An interim efficacy analysis is scheduled for the second half of 2020. Depending on results, recruitment may cease if the primary endpoint is met. The trial has seen a lower-than-anticipated patient dropout rate. Results are expected in early 2021, maintaining blinding post-transplantation.
BioLineRx Ltd. (NASDAQ: BLRX) announced its financial results for Q2 2020, showing a net loss of $6.8 million compared to $5.5 million in Q2 2019. Despite a decrease in research and development expenses by 12.5%, total operating loss stood at $5.6 million. The company raised $13.4 million in gross proceeds from direct offerings, strengthening its balance sheet. Upcoming milestones include three key data readouts in clinical trials for pancreatic cancer and stem cell mobilization expected by year-end.
BioLineRx Ltd. (NASDAQ: BLRX) will announce its unaudited financial results for the quarter ending June 30, 2020, on August 6, 2020, before US markets open. A conference call featuring CEO Philip Serlin will occur the same day at 10:00 a.m. EDT. Investors can dial in or access the call via a webcast on the company's Investor Relations page. The conference call replay will be available for two hours post-live and through August 8, 2020, via designated dial-ins.