Thank you for joining us. Welcome to the BioLineRx Second Quarter 2025 Financial Results Conference Call. I will now hand the call over to Irina Koffler from Investor Relations. Irina, please proceed.

Thank you, operator, and welcome, everyone. Thank you for joining us on our quarterly results conference call. Earlier today, we issued a press release, a copy of which is available in the Investor Relations section of our website. It was also filed as a 6-K. I'd like to remind you that certain statements we make during the call were forward-looking. Because such statements deal with future events and are subject to many risks and uncertainties. Actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 20-F and our quarterly reports on Form 6-K that are filed with the U.S. Securities and Exchange Commission. At this time, it is now my pleasure to turn the call over to Mr. Phil Serlin, Chief Executive Officer of BioLineRx.

Thank you, Irina, and good morning, everyone, and thank you for joining us on today's call. As has been our practice, I will begin with a few prepared remarks before turning the call over to Mali Zeevi, our Chief Financial Officer, to briefly recap our financials. Afterwards, we will take your questions. Ella Sorani, our Chief Development Officer, is also available for Q&A. I'd like to begin this morning with an update on our search for additional early-stage assets, both clinical and preclinical in the areas of oncology and rare diseases to support our pipeline expansion. I am pleased to report today that we are making excellent progress in our evaluation of promising assets, and we continue to target the execution of a transaction this year, giving us an additional opportunity to deliver innovation to patients while creating long-term value for our shareholders. For those who may be new to our story, in November of last year, we announced a transformational exclusive out-licensing agreement with Ayrmid Pharma Limited, which gave them the rights to commercialize APHEXDA, our FDA-approved stem cell mobilization agent indicated in combination for the collection and subsequent autologous transplantation in patients with multiple myeloma. That agreement covers all indications, excluding solid tumor indications such as pancreatic ductal adenocarcinoma, or PDAC, for which we retain the rights and in all territories other than Asia. In exchange, we received an upfront payment as well as commercial milestones and royalties. In addition to being approved for stem cell mobilization, APHEXDA is also being studied in 2 investigator-sponsored Phase I trials, evaluating it for the mobilization of CD34-positive hematopoietic stem cells used in the development of gene therapies for patients with sickle cell disease. The first study is evaluating motixafortide as monotherapy and in combination with natalizumab and is sponsored by Washington University School of Medicine in St. Louis. Data from this program are expected in the second half of this year. The second study is evaluating motixafortide as monotherapy and is sponsored by St. Jude's Children's Research Hospital. So while it is early, the potential broad clinical utility of motixafortide, including in sickle cell disease represents an additional potential source of long-term milestones and royalties for our company. As previously mentioned, as part of the Ayrmid agreement, we retained the rights to motixafortide in pancreatic cancer, and we continue to support its ongoing development in this indication. To that end, a randomized Phase IIb PDAC trial sponsored by Columbia University and supported by both Regeneron and BioLineRx known as CheMo4METPANC continues to enroll patients. The CheMo4METPANC trial is evaluating motixafortide in combination with the PD-1 inhibitor, cemiplimab, and standard of care chemotherapy, gemcitabine and nab-paclitaxel. A prespecified interim analysis is planned for when 40% of progression-free survival events are observed. Results from this trial, if positive, could be a significant value inflection point for our company and signal new hope for patients suffering from this very challenging tumor type. We look forward to keeping you up to date on our progress with this important program. And staying on the topic of the Columbia University PDAC study for a moment, we were very pleased to announce that an abstract detailing new data from the pilot phase of this trial was presented at the 2025 Annual Meeting of the American Society of Clinical Oncology, or ASCO, in May. Recall that in previous presented data, 7 of the 11 patients in the pilot study experienced a partial response, with 6 of those confirmed. That equates to a partial response rate of 64%, which compares very favorably to the historical partial response rate of 23%. 10 of 11 patients or 91% exhibited disease control, which also compares very favorably to a historic disease control rate of 48%. Additionally, median PFS was 9.6 months compared to historic median PFS of 5.5 months. Notably, an analysis of biopsy samples demonstrated a significant increase in CD8-positive T cell density in tumors from all 11 patients treated suggesting the ability of motixafortide combination to overcome the immunosuppressive mechanisms within the tumor microenvironment that render other treatments ineffective. In the updated data that was presented at ASCO, 4 patients have now been progression-free for over a year. Two patients underwent definitive treatment for metastatic PDAC, One had a complete resolution of all radiologically detected liver lesions and underwent radiation to the primary pancreatic tumor, while the other had a sustained partial response and a pancreatic duodenectomy better known as a Whipple procedure, with pathology demonstrating a complete response. We are very excited about the data that continue to emerge from this program. While motixafortide represents an unequivocal demonstration of our ability to develop and launch a new therapeutic agent, the Ayrmid transaction enabled us to return to our roots as a highly innovative company in complex drug development with a very experienced team and a validated track record of clinical and regulatory success. Recall that we successfully advanced motixafortide known commercially as APHEXDA through clinical development and FDA approval in September 2023, giving new hope to the increasing number of multiple myeloma patients who may benefit from an autologous stem cell transplant, yet who have difficulty mobilizing the significant quantities of stem cells required for successful transplantation. Since the Ayrmid agreement, we have been laser-focused on evaluating early clinical stage and late preclinical stage therapeutic assets in oncology and rare diseases that will allow us to leverage this proven expertise in drug development and expand our pipeline. Pleased to report that we continue to evaluate several promising candidates that fit our criteria. Importantly, the subsequent development of any candidates that we identify will have an efficient and clearly defined clinical development path and will be partly funded through milestones and royalties from our license agreement with Ayrmid as well as from our previously announced agreement with Gloria Bio. The current pace of due diligence is actively progressing. And as I said, we are targeting a definitive announcement this year. I want to underscore that our diligence process is lengthy and intensive and includes deep verification of preclinical data, intellectual property and drug manufacturing processes. This thorough process is expected to generate the best results for our shareholders. Our whole team has engaged in these activities since the beginning of the year. In this regard, we are pleased to be well financed as we undertake this endeavor. We ended the second quarter with cash and equivalents of approximately $28.2 million, which is sufficient to fund our operating plan as currently contemplated into the first half of 2027. Note that this represents an extension of our cash runway as compared to our previous guidance, which was through the second half of 2026. Following the announcement of the Ayrmid out-licensing agreement, several BioLineRx commercial team members transitioned to Ayrmid, and we also implemented a broad restructuring of our company, including the shutdown of our U.S. operation that resulted in more than a 70% reduction in our operating cash burn as we entered this year. These decisions, while difficult, have transformed us into a lean and nimble organization capable of quickly seizing on new opportunities that are consistent with our go-forward strategy for the company. In summary, with potential revenue from Ayrmid and Gloria Biosciences, together with a significantly streamlined organization and strengthened balance sheet, we believe we are very well positioned to advance motixafortide in solid tumor indications such as pancreatic cancer, while evaluating and in-licensing additional assets in oncology and rare diseases. Our goal continues to be to help as many patients as possible while creating enduring value for our shareholders. Before turning the call over to Mali to review our financials in more detail, I'd like to briefly touch on APHEXDA's performance in the second quarter. The Ayrmid team continues to make progress driving APHEXDA adoption, generating sales of $1.7 million in Q2 2025, which resulted in $0.3 million of royalty revenues to BioLineRx. We remain optimistic about the role that APHEXDA can play in the new multiple myeloma treatment paradigm as well as in sickle cell disease and look forward to meaningful growth as treatment protocols are updated to reflect the commercial availability of this next-generation stem cell mobilization agent.

Thank you, Phil. As is our practice, I will only go over the most significant items in our financial statements, revenues, cost of revenues, research and development expenses, sales and marketing expenses, net loss and cash. I invite you to review the 6-K filing we made this morning, which contains our financial and press release. Total revenues for the second quarter of 2025 were $0.3 million reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Cost of revenues for second quarter of 2025 was immaterial compared to cost of revenues of $0.9 million for the second quarter of 2024. Both revenues and cost of revenues in 2025 are not comparable to the same period in 2024, which primarily related to direct commercial sales by BioLineRx prior to the Ayrmid transaction in November 2024. Research and development expenses for the second quarter of 2025 were $2.3 million compared to $2.2 million for the second quarter of 2024. The small increase related primarily from certain one-time costs associated with the PDAC study at Columbia University, offset by lower expenses related to motixafortide due to out-licensing of U.S. rights to Ayrmid as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount. There were no sales and marketing expenses for the second quarter of 2025 compared to $6.4 million for the second quarter of 2024. The decrease resulted from the shutdown of U.S. commercial operations in the fourth quarter of 2024, following the Ayrmid transaction. General and administrative expenses for the second quarter of 2025 were $0.2 million compared to $1.6 million for the second quarter of 2024. The decrease resulted primarily from the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria, a decrease in payroll and share-based compensation primarily due to a decrease in headcount as well as small decreases in a number of general and administrative expenses. Net loss for the second quarter of 2025 was $3.9 million compared to net income of $0.5 million for the second quarter of 2024. As of June 30, 2025, the company had cash, cash equivalents and short-term bank deposits of $28.2 million, sufficient to fund operations as currently planned into the first half of 2027.

And with that, I'll turn the call back over to Phil. Thank you, Mali, and thank you to everyone joining this call. Operator, we will now open the call to questions.

The first question is from Joe Pantginis of H.C. Wainwright.

A few, if you don't mind. So first, Phil, can you remind us with regard to the CheMo4METPANC study, does Regeneron have any options or right of first looks or refusals?

No, they do not. This is simply a clinical collaboration for both sides. We will have access to the data in the future, but as far as I know, there is no option for a part for sure. Additionally, as far as I know, there's no option on the Regeneron side either.

Got it. And then with regard to the conduct of the study and the data, you obviously stated and we all knew this anyway that you need a 40% PFS event rate to be able to trigger an interim there. Do you anticipate that, that would release data or be sort of a continuous plan type of announcement? And then overall, when the study is completed based on the unmet medical need, do you believe there's any potential for filing on this study for an accelerated standpoint?

Mali, would you like to take that?

Yes, I can address that. The interim analysis is a prespecified part of the protocol, and it will be conducted in relation to the publication. Phil, I will let you take over from here; it is an investigator-initiated study. I'm not sure if...

Yes. I would like to say that we aim to publish that data or at least confirm that the study is ongoing. Closing the issue with Colombia is important for us. Additionally, I believe they have the rights to publish that data first, so we will need to discuss the timing with them to gain clarity.

Understood. Go ahead, sorry.

Regarding your second question, based on this interim analysis, it may provide a pathway for accelerated approval. However, I doubt it because achieving 40% of the events in this 100-patient study is likely insufficient for accelerated approvals. Additionally, since it's based on progression-free survival, whereas the standard primary endpoint for approval is overall survival, I do not foresee it leading to accelerated approval from the interim analysis that follows 40% of the events.

Okay. Good. And then you guys are obviously busy with your academic collaboration. So I want to focus specifically on the sickle cell study. If you could sort of give us what should we and the industries be looking for out of the study with regard to key metrics and endpoints, the overall expectations?

We will be focusing on the mobilization aspect. Data related to mobilization will emerge from these studies, including the WSHU, specifically the WAHU study, which explores motixafortide both as a standalone treatment and in combination with natalizumab. Although these are investigator-initiated studies, we expect to see data concerning the mobilization for both treatment arms. Any additional data...

Yes, I can add to that. So of course, one of the most important endpoints of this study is safety because it's the first time that sickle cell disease patients have been mobilized with motixafortide. The second aspect is, of course, the mobilization into peripheral blood. So cells per microliter in the peripheral blood, which is correlative to the collection yield. And the third would be collection yield in sickle cell disease patients. As you remember, there was a preliminary results presented in last year's ASCO as an oral presentation, results from 7 patients, which showed very promising results in all these parameters, especially if you compare it to the historical control of plerixafor. For example, just to remind you, the monetization to peripheral blood, the mean and median values with motixafortide where the median was around 200 cells per microliter. That mean was 300 cells per microliter, you compare this to the benchmark of mobilization with plerixafor. It's less than 100 cells per microliter, just as a high-level comparison. And also the collection yields, the very high and promising. And so this, I think, will be the outcomes from this study. What you will not get from this study, of course, is data on manufacturing.

Understood. My last question is about the due diligence you've been conducting regarding new assets. If I understood correctly, Phil, you mentioned there are currently two assets that are at the forefront. Can you provide some insight into the stages of these assets? Will they be accretive, or are they late-stage? How should we anticipate the near to intermediate-term impact on the P&L?

Yes, we are aiming to close a transaction this year. While I cannot guarantee it will happen, that is our goal. We are focused on early-stage assets, particularly those in our area of expertise, which includes early clinical stage assets from IND through Phase I. We are also looking for assets with a clear and well-defined development plan that are financially feasible for us, as we prefer not to engage in assets that necessitate a large upfront payment. We have significant experience in acquiring assets, having brought in over 50 assets during the 20 years of our company’s existence. The assets we are currently interested in align well with our development, cost, and transactability criteria, as well as our expertise in fields such as oncology.

The next question is from Justin Walsh of Jones Trading.

Can you provide any additional color on how your ASCO data was received? I don't know if you had an interesting feedback from physicians or potential partners at the conference.

ASCO data.

ASCO data from the pancreatic study, you mean?

Yes. Yes.

Okay. Yes. So what I can tell you there was excitement. There are some aspects in the results that are very promising, in particular the results on the liver mets, which is something that is very unusual to see a reduction in liver mets. So we received very exciting feedback with that regard in particular to that finding.

The next question is from John Vandermosten of Zacks.

Can you provide more details on your progress in identifying new assets? What are the most appealing sources you have found for some of the pipeline candidates? I usually consider universities, public-private companies, and large pharmaceutical companies that may have projects they lack the resources to pursue, especially if they are too small for them. What sources are you currently exploring?

Yes, that's a good question. We are considering all of those sources, but generally speaking, academic institutions are less relevant for clinical stage projects as they are typically at earlier stages of development. However, they can be a better source for interesting and innovative early-stage projects. On the other hand, when we look at companies, there are some interesting assets available. We find it challenging to compete in that area because it usually requires substantial upfront payments and early-stage milestones. We aim to spend as little as possible upfront so we can allocate more resources to development and structure back-ended deals. Overall, we have found that the best source for us is smaller companies, both private and public, mostly private, as it is particularly challenging to raise capital right now. We are discovering valuable assets at smaller companies that have progressed their assets to a certain milestone but lack the capital or development expertise to advance them further. This aligns perfectly with our expertise, as we have been working in early clinical stages for the last 20 years, making this the most fruitful source for expanding our pipeline.

Okay. Yes, that makes perfect sense. Given the funding environment you mentioned, do you feel like you have the upper hand in negotiating? You have a long history of doing this. Compared to previous periods, do you feel like you are in a stronger position now than you were in the last 20 years?

That's a great question. I believe we are in a stronger position now because we have a proven development track record. Over the past decade, we primarily focused on motixafortide, rather than pursuing many in-licensing opportunities. In the past, when we communicated our ability to manage and advance assets, there was some skepticism due to our lack of validation. However, with our recent FDA approval and the validation that comes from our clinical development success, it's easier for us to demonstrate that, although we may not have the financial resources to compete with others, we can advance the asset efficiently and effectively towards potential approval. This perspective is resonating more now than before.

This concludes the question-and-answer session. Before I ask Mr. Phil Serlin to go ahead with his closing statement, I would like to remind participants that a replay of this call is scheduled to begin 2 hours after the conference. In the U.S., please call 1 (888) 295-2634. In Israel, please call (03) 9255-904. Internationally, please call 9723-9255-904. Mr. Serlin, would you like to make your concluding statement?

Yes. Thank you, operator. In closing, we remain very excited about this new vision for BioLineRx, and we are making excellent progress in our due diligence as we work to identify new assets for in-licensing and development that would expand our pipeline and give us additional opportunities for value creation. As mentioned, we are targeting a potential announcement this year. Thank you all very much for your continued interest in BioLineRx. We look forward to providing our next comprehensive quarterly update in November. Be safe and have a great day.

Thank you. This concludes the BioLineRx Second Quarter 2025 Conference Call. Thank you for your participation. You may go ahead and disconnect.