BioLineRx (NASDAQ:BLRX) executives highlighted progress on the company’s newly added oncology program GLIX1, provided updates on partnered motixafortide development efforts, and reviewed full-year 2025 financial results during its fourth-quarter and full-year conference call.
GLIX1 set to enter first-in-human glioblastoma study
CEO Phil Serlin said BioLineRx is preparing to initiate a first-in-human phase I/II-A clinical trial of GLIX1 in glioblastoma (GBM) and other high-grade gliomas by the end of the month, following FDA approval of Hemispherian’s Investigational New Drug (IND) application last August. The company expects patient treatment to begin shortly after initiation.
Management also noted GLIX1 has received orphan drug designation from both the FDA and the European Medicines Agency, which Serlin said is associated with expedited review and other benefits.
Trial design, timing, and participating centers
Chief Development Officer Ella Sorani said the phase I portion is expected to enroll up to 30 patients with recurrent and progressive GBM and other high-grade gliomas, with the primary goal of establishing a maximum tolerated dose and/or recommended dose based on safety, pharmacokinetics/pharmacodynamics (PK/PD), and preliminary efficacy. The company expects data from phase I in the first half of next year.
In response to a question about the potential for interim efficacy updates, Sorani emphasized the dose escalation study is focused on safety and dose selection and “is not necessarily designed and for sure not powered in order to assess efficacy,” though efficacy will be evaluated as a secondary endpoint.
The phase II-A expansion is planned to include multiple cohorts, including newly diagnosed and/or recurrent GBM, as well as other cancers, potentially in combination with standard-of-care agents such as PARP inhibitors. Serlin said these cohorts are intended to generate preliminary efficacy and dose optimization data to support subsequent development.
Three academic centers are slated to participate, with NYU Langone Health expected to begin enrollment first, followed by Northwestern University and Moffitt Cancer Center. Sorani said investigators have shown “real enthusiasm” based on the novelty of the mechanism and preclinical results, adding that discussions with sites have been frequent as the study approaches launch.
On measuring blood-brain barrier penetration in the clinical study, Sorani said biopsies are being taken but are not mandatory, and the trial is not designed as a phase zero or window-of-opportunity study. She said tissue sampling may be possible in patients who undergo biopsy, but there is no guarantee.
Broader GLIX1 opportunity and intellectual property
Serlin framed glioblastoma as a large unmet need with limited therapeutic advancement since the 2005 standard of care, which includes surgery, radiotherapy, and temozolomide. He cited median overall survival in the range of 12 to 18 months and said most patients die within less than 18 months.
He also discussed market sizing assumptions, stating that by 2030 annual incidence is expected to be about 18,500 patients in the U.S. and about 13,500 across “EU 4 + 1” (France, Germany, Italy, Spain, and the United Kingdom). Serlin said the total addressable market across newly diagnosed and recurrent settings exceeds $3.7 billion in the U.S. and Europe alone, and described it as a “wide open market with few competitors.”
On intellectual property, Serlin said the company received a notice of allowance from the U.S. Patent and Trademark Office in November for a patent covering the use of GLIX1 in cancers where cytidine deaminase (CDA) is not overexpressed above a specified threshold. He said the patent would extend protection through 2040, excluding potential patent term extensions of up to five years, and estimated that as many as 90% of cancers fall under that category. Serlin added that GLIX1 is also covered by two additional patent families for use alone and in combination with established anticancer agents, providing protection to at least 2040, excluding extensions.
The company said it is continuing preclinical work to support potential expansion into additional indications and is studying potential synergy with PARP inhibitors.
Motixafortide programs: pancreatic cancer, sickle cell disease, and China partner update
Serlin provided updates on multiple motixafortide efforts that continue following BioLineRx’s licensing arrangements.
- Pancreatic cancer (PDAC): BioLineRx retained rights to develop motixafortide in PDAC and is supporting Columbia University’s randomized phase IIb “Chemo4METPANC” trial evaluating motixafortide with cemiplimab plus gemcitabine and nab-paclitaxel. Serlin said enrollment has accelerated and a pre-specified interim futility analysis is planned when 40% of progression-free survival events have occurred, which he expects to happen this year.
- Sickle cell disease mobilization: Serlin said a phase I investigator-initiated study sponsored by Washington University School of Medicine concluded and that final results were presented as a poster at the American Society of Hematology (ASH) meeting in December. The 10-patient trial evaluated motixafortide alone and with natalizumab to mobilize hematopoietic stem cells for gene therapies. Management said the regimen was safe and well-tolerated and produced robust mobilization and high collection yields. Serlin added that in two subjects previously mobilized with plerixafor, motixafortide (alone and with natalizumab) produced nearly three times greater mobilization and collection yields. A second sickle cell study sponsored by St. Jude Children’s Research Hospital is ongoing and continues enrolling.
- Gloria Biosciences update (China): Serlin said Gloria experienced delays tied to fundraising and financial difficulties, but that the company has “worked out most” issues and paid an overdue milestone payment. He said Gloria has started a stem cell mobilization “bridging study” required for approval in China and has recruited a number of patients. He said the study is blinded and therefore not expected to produce interim readouts, with data anticipated around the middle of next year. Discussions about solid tumor indications were described as ongoing, but Serlin said he had no new information to share there.
APHEXDA royalties, legal resolution, and 2025 financial results
BioLineRx said Ayrmid continues pushing adoption of APHEXDA, generating $6.5 million in 2025 sales, which Serlin said resulted in $1.2 million in royalty revenue to BioLineRx. In response to a question about sales guidance, Serlin said Ayrmid is a private company and has not provided BioLineRx with long-term guidance.
Serlin also provided an update on a dispute with Biokine Therapeutics related to the motixafortide license. He said Biokine filed a complaint in June 2024 alleging breach of contract and seeking $7.2 million and a declaratory judgment. The parties later agreed to binding arbitration, and Serlin said the arbitrator issued a final award in favor of BioLineRx, denying all claims and awarding reimbursement of expenses, including legal fees, to the company.
CFO Mali Zeevi reviewed the year’s financials. Revenue for 2025 was $1.2 million, compared with $28.9 million in 2024, reflecting primarily APHEXDA royalties in 2025 versus license-related payments and U.S. APHEXDA product sales in 2024. Research and development expenses were $8.1 million, down from $9.2 million, primarily due to lower motixafortide expenses following out-licensing, partially offset by GLIX1 initiation costs. General and administrative expenses fell to $3.1 million from $6.3 million, driven largely by reversal of a provision for doubtful accounts after receipt of an overdue Gloria milestone, as well as lower payroll and other expenses. Net loss narrowed to $2.0 million from $9.2 million in 2024.
BioLineRx ended 2025 with $20.9 million in cash equivalents and short-term bank deposits. Management said this is sufficient to fund operations as currently planned into the first half of 2027, and Serlin reiterated the company remains “very lean” following the shutdown of U.S. commercialization operations.
About BioLineRx (NASDAQ:BLRX)
BioLineRx (NASDAQ: BLRX) is a clinical-stage biopharmaceutical company that discovers and develops novel small-molecule therapies to address unmet medical needs. The company focuses on identifying promising drug candidates through licensing and collaboration agreements with academic institutions and biotech innovators, then advancing these candidates through preclinical and clinical development stages. BioLineRx’s pipeline spans oncology, immunology and inflammatory diseases, central nervous system disorders and pain management.
Among its clinical programs, BioLineRx is advancing targeted cancer therapies designed to improve outcomes for patients with difficult-to-treat tumors.
