BioLineRx's Bold Pivot: A New Drug for Untreatable Brain Cancer

TEL AVIV, Israel – November 24, 2025

In a strategic move that signals a significant shift in focus, biopharmaceutical company BioLineRx has placed a major bet on a new frontier in oncology. The company announced a joint venture with Norway's Hemispherian AS to develop GLIX1, a first-in-class oral therapeutic targeting glioblastoma, the most aggressive and lethal form of brain cancer. This venture isn't just another pipeline addition; it represents a calculated reinvestment of capital, made possible by a recent, disciplined corporate restructuring that has reshaped the company's financial landscape and strategic priorities.

The announcement positions BioLineRx to tackle one of modern medicine's most formidable challenges, a disease that has seen little therapeutic innovation in nearly two decades. By leveraging its enhanced financial stability to acquire a high-potential asset, the company is executing a classic biotech playbook: de-risking its future by diversifying into high-need areas while its foundational assets mature.

A New Weapon Against an Old Enemy

Glioblastoma (GBM) remains a grim diagnosis, with a median survival of just 15 months despite a standard of care—surgery, radiation, and chemotherapy—that has been the unchallenged incumbent since 2005. The tumor's aggressive, infiltrative nature and the formidable blood-brain barrier, which blocks most systemic drugs from reaching their target, have created a therapeutic graveyard for countless experimental compounds.

This is the challenging environment that GLIX1 aims to disrupt. Developed by the epigenetic specialists at Hemispherian, GLIX1 is not just another inhibitor. Its novel mechanism of action is designed to turn a cancer cell's own biology against it. The small molecule, which can be taken orally, is designed to cross the blood-brain barrier and selectively activate an enzyme called TET2 within cancer cells. This activation restores levels of a modified DNA base that is often depleted in tumors, a process which in turn triggers catastrophic double-stranded DNA breaks and programmed cell death, or apoptosis, specifically in the cancerous tissue while largely sparing healthy cells.

"Hemispherian's lead asset, GLIX1, is a versatile molecule with a novel mechanism of action that targets the DNA repair mechanism in cancer cells and has demonstrated compelling efficacy in numerous pre-clinical models," stated Philip Serlin, Chief Executive Officer of BioLineRx, in the company's update.

The development path is set for rapid advancement. BioLineRx plans to initiate a Phase 1/2a first-in-human study in the first quarter of 2026. The trial will be led by world-renowned glioblastoma experts Dr. Roger Stupp and Dr. Ditte Primdahl at Northwestern University, lending significant clinical credibility to the program from its inception. The study is designed to efficiently establish a safe and effective dose before expanding into three distinct patient groups, evaluating GLIX1 as a monotherapy, in combination with standard of care for newly diagnosed patients, and in combination with other targeted therapies for different solid tumors.

The Strategic Blueprint: From Restructuring to Reinvestment

The company's ambitious move into glioblastoma would not have been possible without the foundational strategic and financial moves made over the past year. In late 2024, BioLineRx executed a pivotal out-licensing deal, handing over the commercialization rights for its approved stem cell mobilization drug, APHEXDA® (motixafortide), to Ayrmid Ltd. This transaction effectively ended BioLineRx's direct commercial operations in the U.S., leading to a significant reduction in sales and marketing expenses, which fell from $5.5 million in Q3 2024 to zero in Q3 2025.

The result is a leaner, more focused organization. This operational discipline is starkly reflected in the company's financials. The net loss for the third quarter plummeted to just $1.0 million, a dramatic improvement from the $5.8 million loss reported in the same period last year. This financial turnaround has extended the company's cash runway well into the first half of 2027, providing the stability needed to fund long-term, high-impact clinical development.

The joint venture with Hemispherian is the first major deployment of this newly fortified financial position. Under the terms of the deal, BioLineRx will fund and manage all development, committing an initial $5 million over three years. In return, it receives an initial 40% stake in the venture, which can grow to a majority holding of 70% as investment milestones are met. This structure allows BioLineRx to control the clinical and regulatory path of a promising asset while mitigating upfront financial exposure, a prudent strategy for a development-stage company.

A Fortified Moat and a Diversified Attack

While GLIX1 is the new headline asset, its long-term value is buttressed by a robust intellectual property strategy and the steady advancement of BioLineRx's existing pipeline. The U.S. Patent and Trademark Office recently granted a notice of allowance for a key patent covering GLIX1, extending its market exclusivity to 2040 with a potential for five more years. Crucially, the patent covers the drug's use in cancers where a specific enzyme, cytidine deaminase, is not over-expressed—a category estimated to include up to 90% of all cancers. This broad protection transforms GLIX1 from a single-indication drug into a potential platform therapeutic, with a market opportunity that could extend far beyond the initial $3.7 billion glioblastoma market.

Simultaneously, the company's original cornerstone asset, motixafortide, continues to show promise in other difficult-to-treat diseases. Enrollment is ongoing in the CheMo4METPANC Phase 2b trial, which is evaluating motixafortide in combination with immunotherapy and chemotherapy for patients with metastatic pancreatic cancer—another area of profound unmet medical need.

Furthermore, motixafortide is carving out a potentially critical niche as an enabling technology for gene therapies. Final results from a Phase 1 study in sickle cell disease (SCD), accepted for presentation at the upcoming American Society of Hematology (ASH) annual meeting, demonstrated that motixafortide was safe and effective for mobilizing the hematopoietic stem cells required for gene therapy. The data showed robust mobilization, with yields that were 2.7 to 3.2 times higher than the current standard, plerixafor, in a subset of patients. These encouraging results suggest motixafortide could become a vital tool in making curative gene therapies more accessible and successful for patients with SCD.

With a clear strategy, a fortified balance sheet, and a multi-pronged clinical pipeline targeting some of healthcare's most intractable problems, BioLineRx has repositioned itself for its next chapter. The focus now shifts to execution, with the initiation of the GLIX1 trial in early 2026 serving as the next major catalyst in its mission to translate complex science into tangible patient impact.