Company's 2025 Q2 Earnings Call: Contradictions Emerge on Regulatory Strategy, In-Licensing Timelines, Asset Sources, Academic Collaborations, and Sickle Cell Study Expectations

Date of Call: August 14, 2025

Financials Results

• Revenue: $0.3M total revenues in Q2 2025 (royalties from Ayrmid; Ayrmid reported APHEXDA sales of $1.7M), not comparable to Q2 2024 (prior period included direct commercial sales)

Guidance:

• Cash and equivalents of ~$28.2M, sufficient to fund operations into the first half of 2027 (extended vs prior guidance through H2 2026).
• Targeting execution of an in‑licensing transaction this year (no guarantee).
• Investigator‑sponsored data milestones: WUSTL sickle cell data expected H2 2025; CheMo4METPANC has a prespecified interim at 40% PFS events (timing with Columbia).
• APHEXDA commercial traction: Ayrmid Q2 APHEXDA sales $1.7M; BioLineRx royalties $0.3M; expect growth as protocols update.
• Next comprehensive quarterly update scheduled for November 2025.

Business Commentary:

* Asset Search andPipeline Expansion: - BioLineRx is actively pursuing early-stage assets in oncology and rare diseases to expand its pipeline. - The company is focusing on clinical and preclinical stage assets and expects to close a transaction this year. - The impetus for this is BioLineRx's established expertise in drug development and a strategy to leverage its success with motixafortide.

• Cash Position and Runway Extension:
• BioLineRx ended Q2 with $28.2 million in cash and equivalents, extending its cash runway into the first half of 2027.

• This is due to restructuring that included the shutdown of U.S. operations, resulting in a 70% reduction in operating cash burn.

• Ayrmid Pharma Agreement and Revenue:

• BioLineRx received $1.7 million in royalty revenues from Ayrmid in Q2, marking productive adoption of APHEXDA.
• The agreement with Ayrmid has provided BioLineRx with upfront payments, commercial milestones, and royalties from APHEXDA sales.

• Motixafortide in Pancreatic Cancer:
• A randomized Phase IIb trial of motixafortide in pancreatic cancer, CheMo4METPANC, is ongoing.
• The trial is testing motixafortide in combination with cemiplimab and chemotherapy, with an interim analysis planned when 40% of PFS events are observed.

Sentiment Analysis:

Overall Tone: Positive

• Management repeatedly stated progress and optimism: 'we are making excellent progress' on asset evaluations, 'very excited' about PDAC and pipeline activities, highlighted cash of ~$28.2M funding into 1H 2027, and noted APHEXDA Q2 sales of $1.7M generating $0.3M royalties — supporting a constructive outlook.

Q&A:

• Question from Joseph Pantginis (H.C. Wainwright & Co, LLC): Can you remind us with regard to the CheMo4METPANC study, does Regeneron have any options or right of first looks or refusals?
  Response: No — Regeneron has no option or ROFR; the relationship is a clinical collaboration and BioLineRx will have access to the data.

• Question from Joseph Pantginis (H.C. Wainwright & Co, LLC): Will the prespecified interim at 40% PFS events release data or be published, and could the interim support accelerated approval?
  Response: The interim is prespecified but Columbia (investigator) controls publication timing; management doubts the 40%‑event PFS interim would justify accelerated approval given study size and PFS vs. OS considerations.

• Question from Joseph Pantginis (H.C. Wainwright & Co, LLC): For the sickle cell investigator‑initiated studies, what key metrics and endpoints should we watch for?
  Response: Key endpoints are safety, peripheral blood CD34+ mobilization (cells/µL) and apheresis collection yield; prior pilot data showed medians ~200 cells/µL (motixafortide) vs <100 for plerixafor and promising collection yields.

• Question from Joseph Pantginis (H.C. Wainwright & Co, LLC): On your due diligence for new assets, are the leading opportunities early or late stage and how should we view near‑to‑intermediate term P&L impact?
  Response: Targeting early clinical (IND through Phase I) assets with clear development paths and back‑ended deals; aiming to close a transaction this year but not expecting significant near‑term P&L accretion.

• Question from Justin Howard Walsh (JonesTrading Institutional Services, LLC): Can you provide additional color on how your ASCO data was received and any feedback from physicians or potential partners?
  Response: Reception was positive and there was particular excitement about the unusual reductions in liver metastases observed in the pancreatic study.

• Question from John D. Vandermosten (Zacks Investment Research, Inc.): What are the most attractive sources for pipeline candidates (universities, companies, big pharma)?
  Response: Management is reviewing all sources but finds smaller private companies (with assets at certain milestones but limited capital) are the best fit for in‑licensing given transactability and cost profile.

• Question from John D. Vandermosten (Zacks Investment Research, Inc.): Given the funding environment, do you have more negotiating leverage now compared to prior periods?
  Response: Yes — having FDA approval and a validated development track record improves their position and credibility, making it easier to propose efficient, development‑focused deals despite limited upfront payments.

Contradiction Point 1

Regulatory Strategy for the CheMo4METPANC Study

It concerns the regulatory strategy for the CheMo4METPANC study, which is crucial for the company's future pipeline and regulatory approval.

Will the data be released in phases or as a continuous announcement? Once the study is completed addressing unmet medical needs, is there potential to file for accelerated approval? - Joseph Pantginis (H.C. Wainwright)

2025Q2: A study with PFS as the primary endpoint may not lead to regulatory approval, as typically the primary endpoint is overall survival. - Mali Zeevi(CFO)

How will the interim analysis at 40% PFS events be communicated, and what is the regulatory strategy moving forward? - Joe Pantginis (H.C. Wainwright)

2025Q1: The communication strategy is aligned with Columbia University's, and data will be published once available. Regarding regulatory strategy, a study with PFS as the primary endpoint may not lead to regulatory approval, as typically the primary endpoint is overall survival. - Philip Serlin(CEO)

Contradiction Point 2

Timeline for In-Licensing Transactions

It involves the expected timeline for completing in-licensing transactions, which impacts the company's growth and development strategy.

Can you clarify the current stage of the two potential deals (e.g., potential accretion status and timeline) and their near-to-intermediate-term impact on the P&L? - Joseph Pantginis(H.C. Wainwright)

2025Q2: We're targeting closing a transaction this year. I can't promise that it will happen, but we're targeting closing a transaction this year. - Philip A. Serlin(CEO)

Can you explain the progress in evaluating potential assets and the stage of these discussions? - Joe Pantginis(H.C. Wainwright)

2024Q4: We are in discussions, and we are looking at very early-stage assets. Some of those could be IND-stage, Phase I-stage, and we have those discussions. And again, we are looking at ways to really maximize the value by not paying upfront but by paying based on the development milestones. - Phil Serlin(CEO)

Contradiction Point 3

Source of Assets

It involves the primary sources of assets for in-licensing, which impacts the company's ability to successfully acquire and develop new assets.

What are the most attractive sources for pipeline candidates, such as universities, private companies, or big pharma, that you're targeting due to size constraints? - John D. Vandermosten(Zacks)

2025Q2: We are looking at all of those sources, of course. I'd have to say generally, and these are broad generalization. Academic institutions are less of a source from our perspective for clinical stage projects. They usually are at earlier stages of development. - Philip A. Serlin(CEO)

How many assets are you evaluating, and what's the breakdown between oncology and rare disease? - John Vandermosten(Zacks)

2024Q4: We are focused on early clinical stage assets in oncology and rare diseases. The majority of the projects are in oncology, with a minority in rare diseases. - Phil Serlin(CEO)

Contradiction Point 4

Academic Collaborations and Clinical Studies

It involves differing perspectives on the nature of collaboration with academic institutions and the expectations from clinical studies, which could impact strategic planning and resource allocation.

What are the most attractive sources you've identified for pipeline candidates? - John D. Vandermosten (Zacks)

2025Q2: Academic institutions are less of a source from our perspective for clinical stage projects. - Philip A. Serlin(CEO)

What are the top one or two early factors transplant centers see as truly differentiated for APHEXDA? - Joe Pantginis (HC Wainwright)

2024Q1: On the academic front overall, again, on a historical basis, we have 50 academic institutions, all of which we have some ongoing programs with, many of them resulting in ongoing drug development programs. - Phil Serlin(CEO)

Contradiction Point 5

Sickle Cell Disease Study Expectations

It highlights differing expectations for the outcomes and implications of the sickle cell disease study, which could impact clinical development strategies and investor expectations.

What key metrics, endpoints, and overall expectations should we and the industry look for in the sickle cell study? - Joseph Pantginis (H.C. Wainwright)

2025Q2: There should be data relating to the mobilization of both of those arms. - Philip A. Serlin(CEO)

With safety demonstrated in the Washington University trial, is there expected demand for APHEXDA in gene therapy clinical trials? Are other studies pending validation? - John Vandermeston (Zacks)

2024Q1: We are actively speaking with many potential partners and anticipate additional clinical trials in the future. The success of the sickle cell trial could lead to increased interest in APHEXDA for gene therapy trials. - Phil Serlin(CEO)