BLRX

• GLIX-1 Program Update:

  • GLIX-1 is an oral, first-in-class small molecule activating TET2 enzyme to induce DNA damage in cancer cells, showing excellent blood-brain barrier penetration and a clean safety profile.
  • Phase 1-2A trial initiated in March; first patient dosed in April at NYU Langone Health, with additional enrollment at Northwestern University and Moffitt Cancer Center.
  • Recruitment is progressing well; dosing commenced in the second of five Phase 1 cohorts, with the third cohort expected to start in September.
  • Preclinical data presented at ENO 2026 and SNO 2026 showed potent anti-tumor effects in glioblastoma (GBM) models, including temozolomide-resistant PDX models where standard care failed.
  • Strong synergy observed between GLIX-1 and PARP inhibitor Olaparib in HR-proficient ovarian cancer models, achieving tumor reduction comparable to cisplatin despite lower doses.
  • Phase 1 data anticipated in H1 2027; Phase 2A will expand to include GBM and potentially ovarian cancer cohorts.
  • Management has commenced discussions with leading PARP inhibitor developers regarding potential collaborations.

• Pancreatic Cancer (PDAC) Program:

  • Columbia University is executing the randomized Phase IIb 'Chemo for MedPank' trial evaluating motixifortide combined with sintilimab and standard chemotherapy.
  • Enrollment is tracking well; a pre-specified interim futility analysis is planned when 40% of progression-free survival events are observed, expected later this year.
  • Management acknowledges recent approvals may shift the treatment landscape but maintains that there remains significant unmet need and room for CXCR4 inhibition strategies.

• Afexa Commercialization:

  • Partner Airmid continues to drive adoption, generating $1.6 million in sales in Q2 2026.
  • Market penetration into transplant centers is ongoing, though management notes that changing treatment paradigms takes time, similar to the historical trajectory of Pluristem’s Plurista.

• Financial Position & Cash Flow:

  • Ended Q2 2026 with $13.1 million in cash and equivalents, sufficient to fund operations into H1 2027.
  • Raised an additional $3.75 million via registered direct offering subsequent to the quarter-end.
  • Supported by non-dilutive funding from royalties and milestones from license agreements with Airmid and Gloria Biosciences.

• Cash Runway: Management confirmed that existing cash reserves of $13.1 million, plus the recent $3.75 million raise, are sufficient to fund the operating plan into the first half of 2027.
• Clinical Milestones:
  • Phase 1 data for GLIX-1 is expected in the first half of 2027.
  • Interim futility analysis for the PDAC trial is expected later this year (2026).

The company operates primarily through its proprietary clinical-stage assets and royalty income from licensed products. There are no distinct internal product segments with separate revenue reporting, but financial performance is driven by the following sources:

1. Royalty Revenue (Afexa/Airmid):

   • Absolute Performance: Generated $1.6 million in sales for the Afexa product by partner Airmid during Q2 2026, resulting in $0.3 million in royalty revenue for BioLineRx.
   • Revenue Contribution: Royalties constituted 100% of the total reported revenues for the quarter ($0.3 million).

2. Clinical Assets (GLIX-1 & Motixifortide):

   • These are pre-revenue stages. No direct revenue was generated, but they incurred significant R&D expenses.
   • R&D Expenses: Total R&D expenses were $2.9 million, an increase of $0.6 million year-over-year, primarily due to costs associated with the new GLIX-1 project, partially offset by lower expenses for Motixifortide.

• Clinical Development Risks: GLIX-1 and motixifortide are in early stages; failure to demonstrate efficacy or safety in upcoming trials could halt development.
• Regulatory and Competitive Landscape: Recent approvals in pancreatic cancer may alter the standard of care, potentially impacting the value proposition of motixifortide if the interim futility analysis is not favorable.
• Commercial Adoption Challenges: Changing physician behavior and treatment paradigms for Afexa is difficult and slow; generic competition exists, which may limit pricing power and market share growth.
• Financial Risk: The company has incurred net losses and relies on external financing; while current cash covers operations until H1 2027, further capital raises may be required before any commercial revenue is realized from core assets.

Q: Analyst asked about the positioning of the GLIX-1 and PARP inhibitor combination in ovarian cancer, specifically regarding the setting and line of therapy given the strong preclinical synergy in HR-proficient models. / A: VP of Clinical Development noted that while the combination outperformed monotherapies and matched cisplatin efficacy in suboptimal dose settings, it is too early to define the exact clinical strategy. They are currently consulting with key opinion leaders to determine the optimal development path, acknowledging that PARP inhibitors are currently approved as maintenance therapy after standard resection and chemotherapy.

Q: Analyst inquired whether recent regulatory approvals in pancreatic cancer would change BioLineRx's approach or objectives for the Chemo for MedPank trial involving motixifortide. / A: CEO Phil Serlin acknowledged that the approval might shift the treatment landscape but maintained confidence in the role of CXCR4 inhibition. He emphasized that significant unmet medical need remains and that the company will await the upcoming interim futility analysis later this year before making strategic decisions on how to proceed with the study.

Q: Analyst questioned whether Airmid’s sales penetration into transplant centers has improved and how the competitive environment, particularly generics, has impacted Afexa’s market performance. / A: CEO Serlin stated that BioLineRx does not provide specific guidance on partner sales operations. He highlighted that generic alternatives have been present since the 2024 launch and that price was not the primary barrier. He compared the situation to Pluristem’s experience, noting that shifting treatment paradigms requires significant time and effort regardless of competitive pressures.