BioLineRx Ltd. Q1 FY2026 earnings call

• GLIX-1 Clinical Development Progress

  • First-in-human Phase 1-2A trial for GLIX-1 (oral small molecule for glioblastoma/GBM and other cancers) initiated in March 2026, with the first patient dosed at NYU Langone Health. Two additional trial sites (Northwestern University, Moffitt Cancer Center) will open shortly, with potential for more sites to be added later.
  • The Phase 1 dose escalation portion will enroll up to 30 patients with recurrent GBM/high-grade gliomas, to evaluate safety, pharmacokinetics/pharmacodynamics, and determine maximum tolerated/recommended dose. Periodic trial updates are expected in H2 2026, with full Phase 1 results in 2027. The Phase 2A expansion will add cohorts for newly diagnosed GBM and other cancers, testing GLIX-1 as monotherapy and in combination with standard of care including PARP inhibitors.
  • New preclinical data shows robust dose-dependent tumor growth inhibition and survival benefit in multiple GBM models, including temozolomide-resistant patient-derived xenografts (where temozolomide showed no effect). Two abstracts of GLIX-1 preclinical data have been accepted for online publication at the 2026 ASCO meeting, highlighting synergistic effect when combined with PARP inhibitors across multiple cancer types.
  • GLIX-1 has a novel mechanism of action (restores TET2 activity to selectively induce DNA damage repair in cancer cells only) and can cross the blood-brain barrier, a key advantage for GBM treatment. The GBM market has high unmet need, with a total addressable market of over $3.7 billion in the U.S. and Europe alone, and few effective competing treatments.

• Muxoxyxoportide (PDAC/Pancreatic Cancer) Development

  • BioLineRx retained rights to develop Muxoxyxoportide for pancreatic cancer, and enrollment in the randomized Phase IIb Chemo4MedPank trial (run by Columbia University, supported by Regeneron and BioLineRx) continues to track on schedule. A pre-specified interim futility analysis is planned for late 2026, when 40% of progression-free survival events are observed.

• Effecsta Commercial and Pipeline Update

  • AirMed (Aramed) reported Effecsta sales of $2.5 million in Q1 2026, up from $1.4 million in Q1 2025, generating $0.5 million in royalty revenue for BioLineRx. Management expects continued sales growth for Effecsta in the multiple myeloma treatment paradigm.
  • Aramed is also developing metixifortide for sickle cell disease (under an outlicensing agreement that excludes solid tumor indications and Asian territories), where there is high unmet need, as current standard of care GCSF is contraindicated for these patients. Encouraging prior results have been reported for this program.

• Quarterly Financial Highlights

  • Total Q1 2026 revenue: $0.5 million, up $0.2 million year-over-year (YOY), driven by higher Effecsta royalties.
  • R&D expenses: $2.5 million in Q1 2026, up $0.9 million YOY, primarily due to increased spending on the GLIX-1 project.
  • G&A expenses: $0.9 million in Q1 2026, down $0.1 million YOY, driven by lower legal and other general operating costs.
  • Net non-operating income: $0.5 million in Q1 2026, down from $7.6 million in Q1 2025, driven by non-cash fair value adjustments of warrant liabilities tied to changes in the company's share price.
  • Net loss for Q1 2026: $2.6 million, compared to net income of $5.1 million in Q1 2025. Cash and equivalents at quarter end: $17.4 million, sufficient to fund current operations into the first half of 2027.

BioLineRx reports only aggregated financial results in this call, with no separate breakdown of distinct product segment revenue or contribution percentages. The only revenue generated in the quarter was royalty revenue from Effecsta commercialization by partner Aramed/AirMed, which totaled $0.5 million for Q1 2026, up from $0.3 million in Q1 2025. All operating expenses are grouped into research and development (R&D) and general & administrative (G&A) categories, with no separate segment-level expense or profit data disclosed.

• Cash runway: Management confirms existing cash and equivalents of $17.4 million is sufficient to fund the current operating plan into the first half of 2027, with no changes to prior cash runway guidance.
• GLIX-1 trial updates: Periodic updates on the Phase 1-2A trial are expected in the second half of 2026, with full dose escalation results planned for release in 2027, maintained from prior guidance.
• Muxoxyxoportide interim analysis: The pre-specified interim futility analysis for the Phase IIb pancreatic cancer trial remains on track for the second half of 2026, with no upward or downward revision to timing.
• No changes to long-term revenue or profit guidance were provided in this call.

• Forward-looking statements are explicitly noted to be subject to risks and uncertainties that could cause actual results to differ materially from expectations; key risks are detailed in the company's SEC filings (Form 20F and Form 6K).
• Clinical trial risk: Success of GLIX-1 and Muxoxyxoportide is dependent on achieving positive safety and efficacy results in ongoing trials, which are not guaranteed. Management notes the GBM treatment space has a history of failed drug candidates despite strong preclinical data.
• Dependence on partner performance: Effecsta sales growth and metixifortide development for sickle cell disease are dependent on partner Aramed's resourcing and execution, which BioLineRx does not fully control.
• Market landscape change risk: Recent new data from Revolution Medicines may shift the pancreatic cancer treatment paradigm, requiring future adjustments to Muxoxyxoportide development strategy and creating uncertainty about future development paths.

Q: With GLIX-1 dosing now underway in GBM, what is the competition for patient recruitment, and do you expect recruitment challenges?

A: Management notes the GBM treatment space has very few effective approved or experimental therapeutics, so there is no significant competition for eligible recurrent GBM patients. They report no recruitment issues to date and do not expect problems meeting trial enrollment targets.

Q: Are all three trial centers open and enrolling, and can you share any initial safety observations from the first dosed patient?

A: NYU Langone is open and actively recruiting, while the other two sites will be open very shortly. Management declined to share any initial safety data at this early stage of the trial, and will only release updates periodically as planned later this year.

Q: What are the next steps for the pancreatic cancer Muxoxyxoportide trial after the interim analysis, and what is the expected timeline?

A: The interim futility analysis remains on track for late 2026 as previously planned. Management notes new clinical data from Revolution Medicines may shift the PDAC treatment paradigm, so they will wait for the interim trial data before deciding on the optimal path forward for development, to align with the changing treatment landscape.

Q: Can you share details about Aramed's commercialization efforts for Effecsta (sales team, regions, marketing spend) given Aramed is private and does not disclose this data?

A: Management declined to share specific operational details about Aramed's commercial activities. They did note that year-over-year Effecsta sales grew from $1.4 million in Q1 2025 to $2.5 million in Q1 2026, which is positive growth following Aramed's takeover of commercialization, and management expects this upward sales trajectory to continue.

Q: What is the maximum planned dose for GLIX-1 in the clinical trial, based on the 2000 mg/kg dose used in rat preclinical work?

A: Management declined to disclose specific planned dose levels for the trial as confidential business information. They did confirm that the preclinical safety data provides a very large safety margin for the doses that will be used in human patients.