BioLineRx Realigns Strategy, Pipeline Focus Fuels Future Growth

NEW YORK, NY – November 18, 2025 – BioLineRx Ltd. (NASDAQ: BLRX, TASE: BLRX) is undergoing a strategic transformation, shifting from direct commercialization to a royalty-based model for its approved product, APHEXDA, while simultaneously intensifying its focus on a robust clinical pipeline targeting areas of significant unmet medical need, including pancreatic cancer and glioblastoma. This realignment reflects a broader industry trend towards efficient pathways for bringing innovative therapies to market, even as companies manage financial risk.

APHEXDA: A Shift to Royalty-Based Revenue

BioLineRx’s approved product, APHEXDA (motixafortide), is indicated for stem cell mobilization for autologous transplantation in multiple myeloma patients. Approved in September 2023, APHEXDA represented the first novel stem cell mobilizer for this patient population in a decade, boasting an impressive success rate of approximately 90% in achieving optimal stem cell collection when combined with G-CSF and a single apheresis session. Initially, the company pursued independent U.S. commercialization but opted for a significant strategic shift in late 2024, out-licensing the commercial rights to two key partners.

Ayrmid Ltd. secured exclusive rights for APHEXDA across all indications (excluding solid tumors) outside Asia. This agreement provided BioLineRx with an upfront payment of $10 million, with the potential for up to $87 million in commercial milestones and tiered royalties ranging from 18% to 23% on net sales. Gloria Biosciences holds the exclusive license for the Asian market, having provided an upfront payment of $15 million, along with potential milestone payments and royalties. “This new commercial model allows us to capture value from APHEXDA while reducing our operational and financial burden,” explained one industry analyst. “It’s a smart move that allows the company to focus its resources on pipeline development.”

Advancing Pipeline Programs in Pancreatic and Brain Cancers

Beyond APHEXDA, BioLineRx is actively pursuing clinical development programs in particularly challenging areas of oncology. The company’s motixafortide program is currently being evaluated in a Phase 2b trial for pancreatic ductal adenocarcinoma (PDAC). This trial, CheMo4METPANC, is investigating the combination of motixafortide with Regeneron’s Libtayo and standard chemotherapy as a first-line treatment. Early data suggests the combination may be well-tolerated, and researchers are hoping to see a signal of efficacy. “Pancreatic cancer is notoriously difficult to treat,” noted one researcher involved in the trial. “New therapeutic approaches are desperately needed, and motixafortide offers a novel mechanism that could potentially improve outcomes.”

The company is also developing GLIX1, a novel therapeutic candidate targeting glioblastoma, another aggressive and challenging cancer. A Phase 1/2a trial is planned for early 2026, with the aim of evaluating the safety and preliminary efficacy of GLIX1. GLIX1 targets the DNA damage response pathway, a crucial mechanism in cancer cell survival. The collaboration with Hemispherian AS is critical in accelerating this development program. “Targeting the DNA damage response is a promising strategy in glioblastoma,” stated one expert in the field. “If GLIX1 proves to be effective, it could represent a significant step forward in treating this devastating disease.”

Financial Restructuring and Future Outlook

The strategic shift towards a leaner operation has had a significant impact on BioLineRx’s financial position. The company has undergone significant restructuring, including reducing its operational expenses and shedding non-core assets. This has allowed BioLineRx to extend its cash runway and focus its resources on pipeline development. While the company experienced a net loss of $3.9 million in Q2 2025, the restructuring is expected to yield positive results in the long term.

The company’s improved financial health and promising pipeline programs have attracted the attention of investors. While the stock has experienced volatility in recent months, analysts remain optimistic about the company’s future prospects. “BioLineRx has made some smart strategic decisions,” said one financial analyst. “The company is well-positioned to capitalize on the growing demand for innovative cancer therapies.” The company’s focus on niche indications and its commitment to pipeline development are expected to drive long-term growth and shareholder value.