BioLineRx Ltd. (BLRX) Earnings Call Transcript & Summary

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter 2026 Financial Results Conference Call. [Operator Instructions] I would now like to turn the call over to Chuck Padala, Investor Relations. Please go ahead.

Thank you, operator, and welcome, everyone, and 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 was also filed as a 6-K. I'd like to remind everyone 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-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, Chuck, 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 GLIX1, our highly innovative molecule for the treatment of glioblastoma and other cancers, which we obtained through our collaboration with Hemisphere. GLIX1 is an oral first-in-class small molecule with a novel mechanism of action designed to activate the 102 enzyme and drive tumor DNA damage. By restoring 2 activity GLIX1 selectively induces DNA damage in cancer cells, representing a differentiated approach to targeting the DNA damage response with potential applicability across a broad range of tumors. Glioblastoma was selected as the initial indication due to its highly suppressed 12 activity and significant unmet medical need. GBM remains one of the most aggressive and treatment resistant cancers, and there is an urgent need for breakthrough innovation and more effective treatment options. We believe GLIX1's differentiation is reflected in its excellent blood brain barrier penetration inside of toxicity to patient-derived neurospheres glioma stem cells, its efficaciousness in numerous orthotopic GBM models and a temozolomide resistant PDX model. The fact that it does not rely on the immune system and its very clean safety profile shown in animal toxicity studies, which should allow for longer treatment durations and combination treatment. We initiated our Phase I/IIa clinical trial of GLIX1 gliobastoma and other high-grade gliomas in March, and the first patient was dosed in April at NYU Langdon Health under the supervision of Dr. Alexandra Miller. Two additional academic centers, Northwestern University led by Dr. Roger Stop and Dr. Nina Primdahl, and Moffitt Cancer Center, led by Dr. Patrick Grogan, have also enrolled patients in the Phase I part of this study. I am pleased to report that recruitment to the study is going extremely well, and the trial continues to progress according to plan. Last month, dosing commenced in the second of 5 plant cohorts in Phase I and the third cohort is expected to commence dosing in September. To date, a little more than 4 months since the study, we have been very pleased with the drug safety and tolerability. As a reminder, the Phase I part of the trial is expected to recruit up to 30 patients with a recurrent and progressive GBM and other high-grade gliomas. With the objective of establishing a maximum tolerated dose and/or recommended dose based on safety, PK/PD and preliminary efficacy. We continue to anticipate Phase I data in the first half of 2027. The Phase IIa expansion part of the trial is planned to include additional cohorts, including GBM, newly diagnosed and/or recurrent as well as additional cancers with or without standard of care. For example, PARP inhibitors. The study was accepted for presentation at the European Association of Neuro-Oncology ENO 2026 Conference and at the Society for Neuro-Oncology Snow 2026 Annual Meeting. In May, we were very encouraged to report new preclinical data demonstrating potent antitumor of GLIX1 in GBM across multiple in vivo studies, including a temozolomide resistant patient-derived xenograft model. in 3 orthotopic cell-driven graft or CDX GBM models, GLIX1 produced significant tumor growth inhibition and survival benefit across all doses tested with greater benefit at higher dose levels. Notably, we also completed a subcutaneous temozolomide resistant patient derived xenograft or PDX GBM model. In that model, glycine demonstrated a robust antitumor effect while temozolomide, the current standard of care chemotherapy showed no effect. These results further support GLIX1's potential to treat a broad range of patients with GBM, including those that do not respond to temozolomide. These results will also be presented at the ENO 2026 and SNOW 2026 conferences. In July, we announced highly encouraging new preclinical data, demonstrating strong synergy between GLIX1 and the PARP inhibitor of olaparib in a patient-derived xenograft model of HR-proficient ovarian cancer, a setting where PARP inhibitors have historically shown limited efficacy. The study included 6 arms, cisplatin, GLIX1 monotherapy and olaparib monotherapy, each of their expected optimal doses as well as a low dose GLIX1 arm, a low-dose GLIX1 olaparib combination arm and a control arm. The low-dose GLIX1 olaprib combination arm showed substantially better efficacy than the control arm and versus either molecule as monotherapy despite using lower doses of each agent in the combination. The combination also achieved tumor reduction comparable to cisplatin, the current chemotherapy benchmark in this setting. These results reinforce the synthetic lethality between GLIX1 and PARP inhibitors and support our plan to include an ovarian cancer arm in the Phase IIa expansion part of our ongoing study. Looking ahead, we look forward to presenting our data on GLIX1 and PARP inhibitor synergy across HR proficient ovarian cancer lines as well as the PDX model at the ESMO Annual Conference inventory this October, where the abstract has been accepted for a presentation. Given these data on synergy, we have also commenced initial discussions with several leading developers of PARP inhibitors regarding potential collaborations leveraging GLIX1. As we have said before, but bears repeating, the unmet need in glioblastoma remains significant, it is the most common and aggressive form of primary brain cancer all ages but baking in patients in their 50s and 60s with incidents increasing alongside an aging global population. The current standard of care was established more than 20 years ago with an unlimited improvement since median survival following diagnosis remains approximately 12 to 18 months. By 2030, annual GBM incidents is expected to reach over 18,000 patients in the U.S. and over 13,000 across the EU 4+1, representing a combined total addressable market of more than $3.7 billion in the U.S. and Europe alone. We continue to view this as a wide open market with few competitors. We remain very encouraged by the progress of the GLIX1 program this quarter, both in the clinic and across our expanding preclinical data set, and we look forward to keeping you apprised of our progress as we advance this development across a range of cancers. Turning now to pancreatic cancer or PDAC. Recall that we retained the right development did PDAC as part of the Ermid-ot-licensing agreement, and we continue to support its ongoing development in this indication. Columbia University, supported by both Regeneron and BioLineRx is executing a randomized Phase IIb clinical trial known as chemo for MedPac, and we are pleased to report that enrollment continues to track well. This trial is evaluating motixafortide in combination with the PD-1 inhibitor, cemiplimab, and standard chemotherapy as gemcitabine and [indiscernible]. As noted previously, a prespecified interim futility analysis is planned for when 40% of progression-free survival events are observed expected later this year. I'd now like to briefly touch on FX as per. The Erman team continues to make progress driving FX adoption, generating sales of $1.6 million in the second quarter of 2026, which resulted in a $0.3 million of royal revenue -- royalty revenue to buy line Rx. In terms of cash, we ended the quarter with cash and equivalents of $13.1 million, which is sufficient to fund our operating plan is currently contemplated into the first half of '27, and this past Friday, we announced a $3.75 million offering, which is expected to close later today. We have -- we also have the benefit of nondilutive funding from the royalties and milestone-driven revenue from our license agreements with both Armin and Gloria Biosciences. Now let me turn the call over to Mali to provide a financial update. Malli, please go ahead.

Thank you, Phil. As is our practice, I will only go over the most significant items in our financial statements. revenues, research and development expenses, general and administrative expenses, nonoperating expenses net loss and cash. I invite you to review the 6-K that we filed this morning that contains our financials and press release. Revenues for the 3 months ended June 30, 2026. were $0.3 million, similar to the 3 months ended June 30, 2025. Revenues in both periods primarily reflect royalties earned on [indiscernible] product sales of ex. Research and development expenses for the 3 months ended June 30, 2026, were $2.9 million, an increase of $0.6 million compared to $2.3 million for the comparable 2025 period. The increase resulted primarily from expenses related to the new GLIX1 project, offset by lower expenses related to motixafortide. General and administrative expenses for the 3 months ended June 30, 2026, were $0.9 million, an increase of $0.7 million compared to $0.2 million for the comparable 2025 period. The increase resulted from a reversal of a $0.8 million provision for doubtful accounts in the 2025 period, following receipt of an overdue milestone payment from Gloria. Without regard to this reversal, G&A expenses were slightly lower in 2026 as compared to 2025. Nonoperating expenses amounted to $0.7 million for the 3 months ended June 30, 2026 compared to nonoperating expenses of $1.9 million for the same period in 2025. Nonoperating expenses for both periods primarily relates to fair value adjustments of foreign liabilities on the company's balance sheet. Net loss for the quarter ended June 30, 2026, was $4.3 million compared to a net loss of $3.9 million for the 2025 quarter. As of June 30, 2026, the company had cash, cash equivalents and short-term bank deposits of $13.1 million, sufficient to fund operations and is currently planned into the first half of 2027. As mentioned, subsequent to the balance sheet date, the company raised an additional $3.75 million in a registered direct offering. And with that, I'll turn the call back over to Phil.

Thank you, Malli, and thank you to everyone joining this call. Operator, we will now open the call to questions.

[Operator Instructions] The first question is from John Vandermosten of Zacks.

I guess I'll start out with what the GLIX1 and PARP B inhibitor synergies that you announced. So based on what you're seeing now, how would that be positioned in ovarian cancer? What setting in line of therapy is appropriate for what you're seeing so far in this early stage?

John, I'll let Ella take that question.