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 are 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 US Securities and Exchange Commission. At the 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. 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 GLX-1, our highly innovative molecule for the treatment of glioblastoma and other cancers, which we obtained through our collaboration with Hemispherian.

GLX-1 is an oral, first-in-class, small molecule with a novel mechanism of action, designed to activate the TET2 enzyme and drive tumor DNA damage. By restoring TET2 activity, GLX-1 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 TET2 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 GLX-1's differentiation is reflected in its excellent blood-brain barrier penetration, its cytotoxicity 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 1/2a clinical trial of GLX-1 in glioblastoma and other high-grade gliomas in March, and the first patient was dosed in April at NYU Langone Health under the supervision of Dr.

Alexandra Miller. Two additional academic centers, Northwestern University led by Dr.

Roger Stupp and Dr. Deeda Poorhemmat, and Moffitt Cancer Center led by Dr.

Patrick Grogan, have also enrolled patients in the Phase 1 part of the 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 five planned cohorts in Phase 1, and the third cohort is expected to commence dosing in September. To date, a little more than 4 months into the study, we have been very pleased with the drug safety and tolerability.

As a reminder, the Phase 1 part of the trial is expected to recruit up to 30 patients with 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 1 Phase 1 data in the first half of 2027.

The Phase 2a 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, EANO, 2026 conference, and at the Society for Neuro-Oncology, SNO, 2026 annual meeting.

In May, we were very encouraged to report new preclinical data demonstrating potent antitumor effect of GLX-1 in GBM across multiple in vivo studies, including a temozolomide-resistant patient-derived xenograft model. In three orthotopic cell-derived xenograft, or CDX, GBM models, GLX-1 produced significant tumor growth inhibition and survival benefits across across all doses tested, with greater benefit at higher dose levels.

Notably, we were we also completed a subcutaneous temozolomide-resistant patient-derived xenograft, or PDX, GBM model. In that model, GLX-1 demonstrated a robust antitumor effect, while temozolomide, the current standard of care chemotherapy, showed no effect.

These results further support GLX-1'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 EANO 2026 and SNO 2026 conferences.

In July, we announced highly encouraging new preclinical data demonstrating strong synergy between GLX-1 and the PARP inhibitor 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 six arms: cisplatin, GLX-1 monotherapy, and olaparib monotherapy, each at their expected optimal doses, as well as a low-dose GLX-1 arm, a low-dose GLX-1-olaparib combination arm, and a control arm.

The low-dose GLX-1-olaparib 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 GLX-1 and PARP inhibitors, and support our plan to include an ovarian cancer arm in the Phase 2a expansion part of our ongoing study. Looking ahead, we look forward to presenting our data on GLX-1 and PARP inhibitor synergy across HR-proficient ovarian cancer lines as well as the PDX model at the ESMO annual conference in Madrid 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 GLX-1. As we have said before, but it bears repeating, the unmet need in glioblastoma remains significant.

It is the most common and aggressive form of primary brain cancer, occurring at all ages, but peaking in patients in their 50s and 60s, with incidence increasing alongside an aging global population. The current standard of care was established more than 20 years ago, with only limited improvements since.

Median survival following diagnosis remains approximately 12 to 18 months. By 2030, annual GBM incidence is expected to reach over 18,000 patients in the US, and over 13,000 across the EU4+1, representing a combined total addressable market of more than $3.7 billion in the US 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 GLX program this quarter, both in the clinic and across our expanding preclinical dataset.

We look forward to keeping you apprised of our progress as we advance its development across a range of cancers. Turning now to pancreatic cancer, or PDAC.

Recall that we retain the rights to development of motixafortide in PDAC, as part of the Ayrmid out-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 2b clinical trial, known as Chemo4METPanc, 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 chemotherapies gemcitabine and nab-paclitaxel. 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 APHEXDA's performance. The Ayrmid team continues to make progress driving APHEXDA adoption, generating sales of $1.6 million in the second quarter of 2026, which resulted in a $0.3 million of royalty revenue to BioLineRx.

In terms of cash, we ended the quarter with cash and equivalents of $13.1 million, which is sufficient to fund our operating plan, as currently contemplated, into the first half of 2027. This past Friday, we announced a $3.75 million offering, which is expected to close later today.

We have all We also have the benefit of non-dilutive funding from the royalties and milestone-driven revenue from our license agreements with both Ayrmid and Gloria Biosciences. Now, let me turn the call over to Mali to provide a financial update.

Mali, 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, non-operating 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 three months ended June 30, 2026, were $0.3 million, similar to the three months ended June 30, 2025.

Revenues in both periods primarily reflect royalties earned on Ayrmid Gamida Cell's product sales of APHEXDA. Research and development expenses for the three 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 GLX-1 project, offset by lower expenses related to motixafortide. General and administrative expenses for the three 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 account 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.

Non-operating expenses amounted to $0.7 million for the three months ended June 30, 2026, compared to non-operating expenses of $1.9 million for the same period in 2025. Non-operating expenses for both periods primarily relate to fair value adjustments of warrant liabilities on the company's balance sheet.

Net loss for the quarter ended June 30, 2026, was $4.3 million compared to 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 as 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. 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.

Great. Thank you taking my questions.

I I guess I'll start out with uh uh what uh uh the the GLX-1 and PARP inhibitor uh synergies you announced. Based on on what you're seeing now, how would that be positioned in in ovarian cancer?

Um what what setting in line of therapy is appropriate for for what you're seeing so far in this early stage?

Hi, John. How are you?

I'll I'll let Ella take that question.

Yes, hi, John. Uh thank you for the question.

I think it's uh the model tested combination between uh GLX and PARP inhibitor at suboptimal uh concentration compared to monotherapy of each of the arms, and also compared to the chemotherapy monotherapy cisplatin. The combination was better than uh the control, uh better than the monotherapies at higher doses, and uh similar to the effect of cisplatin.

Um as currently PARP inhibitors are um uh yes, and this was uh uh in uh uh HR-proficient patient-derived xenograft model. Uh currently, PARP inhibitors are um approved as maintenance therapy following uh standard of care, which is uh uh resection, and then uh um uh chemotherapy, and then PARP inhibitor as maintenance.

Uh this gives us various option with regards to uh the clinical development plan uh with for this combination. I think, at this stage, is it it's a bit too premature, and we're having still discussions with uh uh ovarian key opinion leaders in order to better tailor the best way forward with this potential combination.

Okay. Thank you, Ella.

I appreciate that insight. Yes, I know it's early, but it's good to hear your thoughts on how that's uh how you're approaching that.

Then um uh we we saw an approval uh recently uh Revolution's darovasertib um and and I'm wondering, does that change your approach on the Chemo4METPanc um objectives at all?

Yeah. We've I think we've spoken about this before.

Um we acknowledge that this is going to potentially change the uh the the treatment landscape in in uh in pancreatic cancer. I think that we still feel that there's a role for motixafortide and for CXCR4 inhibition.

Right now, we're looking forward to seeing the interim futility analysis coming up. Then, we can continue to to push forward on the study.

Once we see some of the results, then we can make a decision, where best to go. We do believe that there will still be room for other treatments, other combinations in PDAC.

It's not, it's there's still a lot of room for a lot of unmet medical need.

Understood. Definitely.

Then, final question on on APHEXDA. I know you're not on the ground there.

Um Ayrmid is is doing that work and they probably don't share all the details with you, but I'm I'm just wondering, larger picture, have they continued to uh penetrate into transplant centers? Then, the competitive environment, has that materially changed, I guess, with, the generics out there for for alternatives?

Um

well, first of all, I think just overall, we can't give much guidance on what's going on. It's Ayrmid is doing the sales.

Even in our, even when we launched the product in 2024, uh there were already, the generics were were many generics were on the market. We didn't find necessarily that the price was, was the the main um, the main impediment, to speak.

I think it's just this is an area where it just takes a lot of work to, to, to change, the the treatment paradigm in general and and et cetera. I think even if you look at Mozobil when it was first uh approved, it took them several years to, to to accelerate their sales.

It was just this is a this is an area where it takes a lot of work uh to, like I said, to change the the standard operating procedures, et cetera, et cetera, at the transplant centers. They're putting all their efforts into it.

I think that we're optimistic as we look down the road.

All right, thank you, Phil, and thanks, Ella and Mali, too. Take care, you guys.

Have a great day.

Yes, thank you, operator. In closing, we remain very excited about our recent progress and we and believe we are well positioned to drive meaningful innovation for patients with some of the most challenging cancer types.

I am very excited about what the future holds for BioLineRx this year and beyond. Thank you all very much for your continued interest in BioLineRx.

Be safe and have a great day.