BioLineRx Ltd. (NASDAQ: BLRX) Q1 2025 Earnings Call | 05/27/2025

BioLineRx Q1 2025 Earnings Call Highlights

BioLineRx's CEO Phil Serlin and CFO Molly Zebi discussed the company's first-quarter 2025 financial results, emphasizing a strategic shift back to complex drug development following a significant out-licensing agreement.

Key Developments & Strategic Shift

• Afexta Out-Licensing: In November 2024, BioLineRx exclusively out-licensed Afexta (also known as Metixoportide), its FDA-approved stem cell mobilization agent, to Aramid Pharma Limited. The agreement covers all indications (excluding solid tumors) and all territories outside Asia, in exchange for an upfront payment, potential commercial milestones, and royalties.
• Afexta Performance under Aramid: After a brief transition period, Afexta has returned to growth under Aramid's management, generating $1.4 million in sales in Q1 2025, resulting in $0.3 million in royalty revenues for BioLineRx. The long-term market opportunity for Afexta is estimated to be in the $100+ million range, with BioLineRx receiving an 18-23% royalty.
• Return to Roots: The Aramid deal allows BioLineRx to refocus on its core expertise in innovative, early clinical and late preclinical stage therapeutic asset development in oncology and rare diseases.
• New Pipeline Search: The company is actively evaluating promising candidates that fit its criteria of having efficient and clearly defined clinical development paths, with funding potentially coming from milestones and royalties from existing license agreements (Aramid and Gloria Bio). A definitive announcement regarding new assets is anticipated later this year.

Financial Highlights (Q1 2025)

• Revenues: Total revenues for Q1 2025 were $0.3 million, primarily from Afexta royalties. This is significantly down from $6.9 million in Q1 2024, which included a portion of the upfront and milestone payments from the Gloria License Agreement.
• Cost of Revenues: Immaterial in Q1 2025, compared to $1.5 million in Q1 2024.
• Research & Development (R&D) Expenses: Decreased to $1.6 million (from $2.5 million in Q1 2024) due to lower expenses related to Metixoportide support after the Aramid out-licensing and reduced headcount.
• Sales & Marketing (S&M) Expenses: Zero in Q1 2025 (compared to $6.3 million in Q1 2024) due to the shutdown of U.S. commercial operations following the Aramid transaction.
• Net Income: $5.1 million (compared to a net loss of $0.7 million in Q1 2024), primarily driven by non-operating income from the re-evaluation of warrants on the balance sheet.
• Cash Position: Ended Q1 2025 with $26.4 million in cash, cash equivalents, and short-term bank deposits.
• Cash Runway: Projected to fund operations through the second half of 2026, factoring in potential new asset development costs which could be offset by milestones and royalties.
• Cost Reduction: The U.S. operations shutdown and headcount reduction in Israel have cut ongoing operating cash burn by over 70%, from over $40 million annually to less than $12 million.

Clinical Program Updates

• Sickle Cell Disease (SCD) Gene Therapy: The Aramid agreement covers ongoing development of Afexta in SCD patients undergoing gene therapy. Two Phase 1 investigator-initiated trials are ongoing.
  • Washington University Trial: Initial results presented at ASH 2024 suggested Afexta alone or with natalizumab could enable collection of required stem cells in a single apheresis cycle.
  • St. Jude Children's Research Hospital Trial: Also ongoing with leading SCD researchers.
• Pancreatic Cancer (PDAC) - Chemo4MetPank Trial: BioLineRx continues to support the development of Metixoportide in PDAC, as it targets CXCR4 overexpression common in PDAC and previously showed promising results in combination with a PD-1 inhibitor and chemotherapy.
  • Randomized Phase 2b Trial: Sponsored by Columbia University and supported by Regeneron and BioLineRx, it continues to enroll patients. Additional sites have been activated to accelerate enrollment.
  • Interim Analysis: A pre-specified interim analysis is planned for 2026 (when 40% of PFS events are observed).
  • ASCO 2025 Presentation: New data from the pilot phase of the Chemo4MetPank trial will be presented, showing a 64% partial response rate (vs. 23% historical), 91% disease control rate (vs. 48% historical), and median PFS of 9.6 months (vs. 5.5 months historical). Biopsy samples showed increased CD8-positive T-cell density, indicating overcoming immunosuppression. Two patients achieved complete resolution or sustained partial response, leading to definitive treatment.