On November 15, 2022 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, reported third quarter financial results and recent corporate and portfolio updates (Press release, BioLineRx, NOV 15, 2022, View Source [SID1234624095]).
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"The Company delivered outstanding performance during the third quarter and subsequent period. Last week’s FDA acceptance of our new drug application for APHEXDA (motixafortide) substantially advances our twin goals of delivering an important new therapy for the mobilization of stem cells in preparation for autologous transplantation in patients with multiple myeloma, and in parallel, transitioning to a commercial stage company," said Philip Serlin, Chief Executive Officer of BioLineRx. "Importantly, we took steps that allow us to rapidly commercialize APHEXDA, if approved, including securing financing, building out our U.S. operations, and progressing our launch strategy. We believe that APHEXDA has the potential to become the standard-of-care mobilizing agent for multiple myeloma patients."
"Additionally, working with our collaborators, we advanced motixafortide development programs for pancreatic cancer, reflecting motixafortide’s potential broad clinical utility. Finally, we anticipate sharing data from the Phase 1/2a trial of our solid tumor investigational immunotherapy AGI-134 prior to year-end. We believe we are well-positioned to execute across all of our programs and continue to aggressively plan for the potential launch of APHEXDA next year," Mr. Serlin concluded.
Recent Corporate Updates
Completed $40 million non-dilutive debt financing agreement with Kreos Capital and $15 million registered direct offering to support commercial launch of APHEXDA in the U.S.
Announced APHEXDA U.S. commercialization plan and named Holly May, President, BioLineRx USA
Portfolio Execution
Motixafortide (selective inhibitor of CXCR4 chemokine receptor)
Multiple Myeloma
Announced FDA acceptance of APHEXDA NDA in stem cell mobilization for autologous transplantation in multiple myeloma patients. PDUFA target action date set for September 9, 2023
Announced presentation of cost-effectiveness analysis of 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 is being held December 10-13, 2022, in New Orleans, Louisiana
Pancreatic Ductal Adenocarcinoma (PDAC)
Began Phase 2b PDAC randomized clinical trial preparation activities with collaboration partner GenFleet. Anticipate clinical trial initiation in 2023. The collaboration agreement allows BioLineRx to retain global rights to motixafortide in all indications
Continued collaboration progress in Columbia University investigator-initiated Phase 2 study of motixafortide in combination with an anti-PD-1 and standard-of-care chemotherapy in first-line PDAC patients
Sickle Cell Disease & Gene Therapy
Announced presentation of clinical trial study design of novel stem cell mobilization regimen with motixafortide to support gene therapy development for sickle cell patients at the ASH (Free ASH Whitepaper) Annual Meeting, which is being held December 10-13, 2022, in New Orleans, Louisiana
AGI-134 (synthetic alpha-Gal glycolipid)
Solid Tumor Immunotherapy
Advanced biomarker analysis from the Phase 1/2a trial of AGI-134 in solid tumors and anticipate announcing results from Part 2 of the trial by year-end
Third Quarter 2022 Financial Results
Research and development expenses for the quarter ended September 30, 2022, were $4.4 million compared to $4.9 million for the same period in 2021; the decrease resulted primarily from lower expenses related to motixafortide NDA supporting activities, as well as lower expenses associated with the completed motixafortide GENESIS clinical trial, offset by an increase in payroll and related expenses
Sales and marketing expenses for the quarter ended September 30, 2022, were $1.3 million compared to $0.2 million for the same period in 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 quarter ended September 30, 2022, were $1.4 million compared to $1.0 million for the same period in 2021; the increase resulted primarily from an increase in share-based compensation and small increases across several G&A expenses
Net loss for the quarter ended September 30, 2022, was $6.8 million, compared to $5.7 million for the same period in 2021
As of September 30, 2022, the Company had cash, cash equivalents, and short-term bank deposits of $57.3 million and anticipates this will be sufficient to fund operations, as currently planned, into the first half of 2024
Conference Call and Webcast Information
BioLineRx will hold a conference call today, Tuesday, November 15 at 10:00 a.m. EST. To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx’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. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until November 17, 2022; please dial +1-888-295-2634 from the US or +972-3-925-5903 internationally.