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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) reported its financial results for Q2 2021, announcing the successful GENESIS Phase 3 trial of Motixafortide in stem-cell mobilization, meeting all endpoints with p<0.0001. The company plans an NDA submission for Motixafortide in H1 2022, supported by ongoing pharmacoeconomic studies. Financially, BioLineRx ended Q2 with $66 million in cash. R&D expenses increased to $5.1 million, while Q2 net loss was $6.8 million, unchanged from 2020. The company aims for key milestones, including pre-NDA meetings and clinical trial results for its other asset, AGI-134.
BioLineRx Ltd. (NASDAQ: BLRX) will announce its unaudited financial results for Q2 2021 on August 18, 2021, before US markets open. A conference call, featuring CEO Philip Serlin, is scheduled for 10:00 a.m. EDT on the same day. Stakeholders can access the call via the Investor Relations page. BioLineRx focuses on oncology, with its lead program Motixafortide (BL-8040) evaluated in multiple studies, including for pancreatic cancer in collaboration with MSD. The company is also developing AGI-134 for solid tumors.
BioLineRx Ltd. (NASDAQ: BLRX) announces positive Q1 2021 results, emphasizing significant advancements in its Motixafortide therapy for stem-cell mobilization. Topline data from the GENESIS Phase 3 trial showed 88.3% success in patient transplants after one treatment, compared to 10.8% with standard care. The company aims to file an NDA with the FDA in H1 2022. Financially, a $34.5 million public offering strengthened its balance sheet, although the net loss rose to $10.2 million. Cash reserves totaled $58.1 million, supporting future developments.
BioLineRx Ltd. (NASDAQ: BLRX) will announce its unaudited financial results for Q1 2021 on May 26, 2021, before US market opening. A conference call featuring CEO Philip Serlin will take place at 10:00 a.m. EDT on the same day, accessible via the company’s Investor Relations page. The call can be dialed in through +1-866-744-5399 (US) or +972-3-918-0610 (internationally). A replay will be available for two hours post-call and until May 28 at +1-888-295-2634 (US) and +972-3-925-5904 (internationally).
BioLineRx Ltd. (NASDAQ: BLRX) reported favorable top-line results from its GENESIS Phase 3 trial of Motixafortide for bone marrow transplantation in multiple myeloma patients. The trial showed a 4.9-fold increase in patients mobilizing ≥ 6 million CD34+ cells/kg with Motixafortide plus G-CSF, indicating significant efficacy. Additionally, 88.3% of patients achieved transplantation after just one apheresis session. The safety profile was also noted as acceptable. BioLineRx aims to submit an NDA for regulatory approval in the first half of 2022.
BioLineRx Ltd. (NASDAQ: BLRX) announced the presentation of a poster at the AACR Annual Meeting, detailing a Phase 2a study of motixafortide in combination with KEYTRUDA and chemotherapy for metastatic pancreatic cancer. The study, which evaluated 38 patients, highlighted the challenges faced by patients with liver metastases. Key findings include a median overall survival (mOS) of 6.5 months and an overall response rate (ORR) of 21.1%. The company aims to advance discussions for potential collaborations and anticipates final data from a Phase 3 study in stem cell mobilization soon.
BioLineRx Ltd. (NASDAQ: BLRX) reported its financial results for 2020, highlighting positive interim data from its GENESIS Phase 3 trial of motixafortide for stem-cell mobilization, leading to early enrollment cessation. The firm anticipates NDA submission in the first half of 2022. Additionally, the triple combination study of motixafortide with KEYTRUDA and chemotherapy demonstrated improved outcomes in stage IV pancreatic cancer. The year ended with a net loss of $30 million, but the company bolstered its finances with $34.5 million from a public offering, supporting continued development of motixafortide and AGI-134.
BioLineRx Ltd. (NASDAQ: BLRX) will announce its 2020 financial results on February 23, 2021, before US markets open. A conference call is scheduled for the same day at 10:00 a.m. EST, featuring CEO Philip Serlin. Investors can join via the Investor Relations page. The company's lead program, Motixafortide, focuses on oncology and has undergone successful trials. BioLineRx is also advancing a second program, AGI-134, an immunotherapy for solid tumors.
BioLineRx Ltd. (NASDAQ: BLRX) announced the closing of its underwritten offering of 14,375,000 American Depositary Shares (ADSs) at $2.40 each, raising approximately $34.5 million in gross proceeds. The offering, managed by H.C. Wainwright & Co., included the full exercise of their option for an additional 1,875,000 ADSs. Proceeds will support general corporate purposes, including working capital and clinical trials. BioLineRx, focused on oncology, is advancing its lead program Motixafortide and developing AGI-134 for cancer treatment.
BioLineRx Ltd. (NASDAQ: BLRX) announced an increase in its offering of American Depositary Shares (ADSs) to 12.5 million at $2.40 each due to demand, expecting gross proceeds of around $30 million. The offering is set to close on or about January 22, 2021. The underwriter, H.C. Wainwright & Co., has a 30-day option to purchase an additional 1.875 million ADSs. The proceeds will be used for corporate purposes, including funding clinical trials. The offering follows a previously filed shelf registration with the SEC.