On March 22, 2023 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, reported its audited 2022 annual financial results for the year ended December 31, 2022, and provided recent corporate and portfolio updates (Press release, BioLineRx, MAR 22, 2023, https://ir.biolinerx.com/news-releases/news-release-details/biolinerx-reports-2022-financial-results-and-recent-corporate [SID1234629154]).
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"Over the last quarter and into this year, we continue to proceed with activities to advance the NDA review process of APHEXDA, while in parallel progressing with pre-launch activities in anticipation of potential approval later this year," said Philip Serlin, Chief Executive Officer of BioLineRx. "Importantly, we recently announced the appointment of our new chief medical officer and completed the formation of our U.S. commercialization team that includes industry veterans with significant and very relevant drug launch and sales experience. Additionally, we announced a new collaboration to evaluate motixafortide for stem cell mobilization for gene therapies in sickle cell disease, which continues our goal of fully maximizing its clinical potential for patients. This is an extremely exciting year for the Company, with the potential commercial approval of our first product, anticipated pancreatic cancer clinical trial data, as well as the planned initiation of two new clinical trials that may further our growth."
Recent Corporate Updates
Appointed Tami Rachmilewitz, M.D. as Chief Medical Officer
Finalized formation of the U.S. commercial leadership team, which collectively has significant drug launch and sales experience, with particular expertise in stem cell mobilization and transplantation
Portfolio Execution
Motixafortide (selective inhibitor of CXCR4 chemokine receptor)
Multiple Myeloma
Announced FDA acceptance of the APHEXDA (motixafortide) NDA in stem cell mobilization for autologous transplantation in multiple myeloma patients. PDUFA target action date set for September 9, 2023
Presented a cost-effectiveness analysis of APHEXDA (motixafortide) versus plerixafor in stem cell mobilization for autologous transplantation in patients with multiple myeloma at the American Society of Hematology (ASH) (Free ASH Whitepaper) 64th Annual Meeting, which was held December 10-13, 2022, in New Orleans, Louisiana. The analysis demonstrated significant net cost savings with APHEXADA (motixafortide)
Pancreatic Ductal Adenocarcinoma (PDAC)
Continued to advance preparation activities for a Phase 2b randomized clinical trial with 200 patients assessing motixafortide in combination with a PD-1 inhibitor and standard-of-care chemotherapy as a first line metastatic PDAC (mPDAC) therapy with collaboration partner GenFleet. Anticipate clinical trial initiation in 2023
Continued collaboration progress with Columbia University investigator-initiated Phase 2 study assessing motixafortide in combination with the PD-1 inhibitor cemiplimab and standard-of-care chemotherapy in first line mPDAC patients. Anticipate initial patient data in 2023
Sickle Cell Disease & Gene Therapy
Announced clinical trial collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell mobilization for gene therapies in sickle cell disease. Anticipate clinical trial initiation in 2023. Clinical trial design was presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 64th Annual Meeting, which was held December 10-13, 2022, in New Orleans, Louisiana
AGI-134 (synthetic alpha-Gal glycolipid)
Solid Tumor Immunotherapy
Announced results from Phase 1/2a study of investigational anti-tumor vaccine AGI-134 in metastatic solid tumors. First-in-human, single-agent study met primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers. The Company is evaluating potential development program pathways in consultation with its scientific advisory board
Financial Results for Year Ended December 31, 2022
Research and development expenses for the year ended December 31, 2022, were $17.6 million compared to $19.5 million for the year ended December 31, 2021. The decrease resulted primarily from lower expenses related to NDA supporting activities related to motixafortide, as well as lower expenses associated with the completed motixafortide GENESIS clinical trial, offset by an increase in expenses associated with the AGI-134 study and an increase in payroll and related expenses
Sales and marketing expenses for the year ended December 31, 2022, were $6.5 million compared to $1.0 million the year ended December 31, 2021. The increase resulted primarily from initiation of pre-commercialization activities related to motixafortide, as well as an increase in market research
General and administrative expenses for the year ended December 31, 2022, were $5.1 million compared to $4.3 million for the year ended December 31, 2021. The increase resulted primarily from an increase in share-based compensation and small increases in a number of general and administrative expenses
Net loss for the year ended December 31, 2022, was $25.0 million, compared to $27.1 million for the year ended December 31, 2021
As of December 31, 2022, the Company had cash, cash equivalents, and short-term bank deposits of $51.1 million and anticipates this will be sufficient to fund operations, as currently planned, into the first half of 2024
A copy of the Company’s annual report on Form 20-F for the year ended December 31, 2022 has been filed with the U.S. Securities and Exchange Commission at View Source and posted on the Company’s investor relations website at View Source Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request at [email protected].
Conference Call and Webcast Information
BioLineRx will hold a conference call today, Wednesday, March 22 at 10:00 a.m. EDT.
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until March 24, 2023; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.