8/14/2025

speaker
Operator
Conference Operator

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx second quarter 2025 financial results conference call. All participants are present in listen-only mode. Song management formal presentation instructions will be given for the question and answer session. I would now like to turn over the call to Irina Kossler, Investor Relations. Irina, please go ahead.

speaker
Irina Kossler
Investor Relations

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 6K. I'd like to remind you that certain statements we make during the call will be 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-X and our quarterly reports on Form 6-K that are filed with the U.S. Securities and Exchange Commissions. At this time, it is now my pleasure to turn the call over to Mr. Phil Sterling, Chief Executive Officer of BioLineRx.

speaker
Phil Sterling
Chief Executive Officer

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 Molly Zeppe, our Chief Financial Officer, to briefly recap our financials. Afterwards, we will take your questions. Ellis Narani, 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 Aramid Pharma Limited, which gave them the rights to commercialize effect stuff. Our FDA-approved stem cell mobilization agent indicated in combination with GCSF with a collection and subsequent oncology 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 receive an upfront payment as well as commercial milestones and royalties. In addition to being approved for stem cell mobilization, Afexa is also being studied in two investigator-sponsored phase 1 trials, evaluating it for the mobilization of CD34-positive hematopoietic stem cells using the development of gene therapies for patients with tickle cell disease. The first study is evaluating metixoportide as monotherapy and in combination with natalizumab and is sponsored by Washington University School of Medicine in Cambridge. Data from this program are expected in the second half of this year. The second study is evaluating metixifortide as monotherapy and is sponsored by St. Jude's Children's Research Hospital. So while it is early, the potential broad clinical utility of metixifortide, 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 ARAMID agreement, we retain the rights to metixifortide in pancreatic cancer, and which continues to support its ongoing development in this education. To that end, a randomized Phase IIb PDAC trial sponsored by Columbia University and supported by both Regeneron and BioLineRx, known as Chemo4MedPank, continues to enroll patients. The Chemo4MedPank trial is evaluated in metixoportiside in combination with the PD-1 inhibitor, Simplimab, and standard of care chemotherapy, gemcitabine, and napaclitaxel. A pre-specified 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 reflection 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 for 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 previously presented data, seven of the 11 patients in the pilot study experienced a partial response, with six 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 CB8-positive 2-cell density in tumors from all 11 patients treated, suggesting the ability of the multisupport type combination to overcome the immunosuppressive mechanisms within the tumor microenvironment that render other treatments ineffective. In the updated data that was presented at ASCO, more 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 underwent a pancreatic code 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 Matissa Fortide represents an unequivocal demonstration of our ability to develop and launch a new therapeutic agent, the AMA 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 Metixifortide, known commercially as Afexa, 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 Aramid Agreement, we have been major 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. I am 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 Aramid 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 result for our shareholders. Our whole team has been 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 license, which was through the second half of 2026. Following the announcement of the airman out licensing agreement, several BioLine RX commercial team members transitioned to Airbnb, and we also implemented the broad restructures of our company, including the shutdown of our U.S. operations. That resulted in more than a 70% reduction in our operating cash flow 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 Airman and Gloria Biosciences, together with a significantly streamlined organization and strengthened balance sheet, we believe we are very well positioned to advance metixoportide and solid tumor indications such as pancreatic cancer while evaluating and 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 Molly to review our financials in more detail, I'd like to briefly touch on Apexa's performance in the second quarter. The Aramid team continues to make progress driving Apexa's adoption, generating sales of $1.7 million in Q2 2025, which resulted in $0.3 million of royalty revenue for myeloma effects. We remain optimistic about the role that Apexa can play in the new multiple myeloma treatment paradigm. as well as in sickle cell disease, and look forward to meaningful growth as proven protocols are updated to reflect the commercial availability of this next-generation stem cell mobilization agent. Now let me turn the call over to Molly to provide a financial update. Molly, please go ahead.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-