5/27/2026

speaker
Operator
Conference Operator

First Quarter 2026 Financial Results Conference Call. All participants are presently in a listen-only mode. Following management's call and presentation, instructions will be given for the question and answer session. For operator assistance during the conference, please press star zero. I would now like to turn over the call to Chuck Pallada, Investor Relations. Chuck, please go ahead.

speaker
Chuck Pallada
Investor Relations

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. It was also filed as a 6K. 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 20F and our quarterly reports on Form 6K 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 BylineRx.

speaker
Phil Serlin
Chief Executive Officer

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 Molly Zeffi, our chief financial officer, to briefly recap our financials. Afterwards, we will take your questions. Ella Surani, our chief development officer, is also available for Q&A. I would like to begin this morning with an update on GLIX-1, a highly innovative molecule for the treatment of glioblastoma, or GBM, and other cancers that we obtained through our collaboration with Hemispherium. In March, we were pleased to announce the initiation of a Phase 1-2A first-in-human trial of GLIPS-1 for the treatment of GBM. And a few weeks later, the first patient was dosed at NYU Langone Health under the supervision of Dr. Alexandra Miller, Chief of Neuro-Oncology and Co-Director of the Brain and Spine Tumor Center, Perlmutter Cancer Center at Langone Health. A total of three renowned academic centers will participate in this clinical trial. In addition to Langone Health, Northwestern University, led by Dr. Roger Stoop and Dr. Dita Creamdahl, and Moffitt Cancer Center, led by Dr. Patrick Grogan, will also be recruiting and treating patients. Additional sites may be added to the study at a later date as well. The phase one part of the trial is expected to recruit up to 30 patients with recurrent GBMs and other high-grade gliomas. The objective is to establish a maximum tolerated dose and or recommended dose based on safety, PKPD, and preliminary efficacy. We expect to provide periodic updates on the trial during the second half of 2026, with full results on the dose escalation part in 2027. The phase 2A expansion part of the trial is planned to include additional indications, including newly diagnosed GBM as well as select cancers, which one is monotherapy or in combination with standard of care, including in combination with PARP inhibitors. These cohorts are expected to identify preliminary efficacy, PD assessment, and dose optimization data, serving as the basis for a rapid and effective advanced clinical development plan. As a reminder, GLIX-1 is an oral small molecule with a novel mechanism of action applicable to a broad range of cancers. By restoring TET2 activity, GLIX1 selectively targets DNA damage repair in cancer cells only. Glioblastoma was selected as the first indication for GLIX1 due to the low level of TET2 activity in this aggressive brain cancer for which there remains a high unmet medical need for novel and more effective treatments. In addition, GLIX1 has demonstrated its ability to cross the blood-brain barrier which is a highly significant differentiator for treating GBM and gives us hope that it may show effect where others have failed in this exceedingly difficult indication. Expanding upon our extensive preclinical work, we were very excited to announce just last week new data demonstrating that GLIX1 achieved robust dose-dependent tumor growth inhibition and survival benefit in several studies in two orthotopic cell-derived xenograms, or CDX, models in GBM. In addition, in a newly completed subcutaneous temozolomide-resistant patient-derived xenograft, or PDX, model in GBM, GLIX-1 demonstrated a robust anti-tumor effect while no effect was observed with temozolomide. These results are very encouraging, highlighting the potential to address the high unmet need in GBM, especially since more than half of GBM patients are resistant to temozolomide, which is the current standard of care chemotherapy. We also look forward to engaging with the broader oncology community over the next few days at this year's ASCO meeting with two abstracts featuring Glix1 that have been accepted for online publication. The abstracts highlight the wealth of preclinical data that support Glix1's novel mechanism of action designed to induce tumor-selected DNA damage in a broad range of cancers, thus providing rationale for the development of Glix1 in GBM and additional cancers as well. They also highlight the compelling mechanistic rationale for combining Glix-1 with PARP inhibitors, supported by a synergistic effect in cell lines across diverse cancers, including tumor types typically less responsive to PARP inhibition. Taken together, the results of our extensive preclinical program for Glix-1 strongly support its continued advancement in the ongoing phase 128 person-human study, both in GBM and in other cancer indications. The unmet need in glioblastoma is significant. It is the most common and aggressive form of primary brain cancer. GBM occurs at all ages but keeps the individuals in their 50s and 60s with an increasing incidence driven by an aging global population. New and better treatments are desperately needed that can improve survival, maintain quality of life, and delay tumor progression. The current standard of care was established more than 20 years ago, with only limited improvement since that time. Treatment includes surgical resection, followed by radiotherapy and concomitant and adjuvant chemotherapy, as mentioned, temozolomide. But the prognosis for patients is poor, with median survival of approximately 12 to 18 months following diagnosis. By 2030, the annual incidence of GBM is expected to be approximately 18,500 patients in the U.S. and approximately 13,500 patients across the EU4 plus 1, France, Germany, Italy, Spain, and the United Kingdom. This translates into total addressable markets across both the newly diagnosed and recurrent settings of more than $3.7 billion in the U.S. and Europe alone. We view this as a wide open market with few competitors. We are incredibly pleased to have brought this highly innovative molecule into our pipeline, and we look forward to keeping reprise of our progress as we pursue its development in a wide range of cancers. Turning now to pancreatic cancer, or PDAC, recall that we retained the rights to develop Muxoxyxoportide in PDAC as part of the Aramid Out Licensing Agreement, and we continue to support its ongoing development in this indication. Columbia University, supported by both Regeneron and BioLine RX, is executing a randomized Phase IIb clinical trial known as Chemo4MedPank, and we are pleased to report that enrollment continues to track well. This trial is evaluating rituxifluortide in combination with the PD-1 inhibitor simiplimab and standard chemotherapies gemcitabine and napaclitaxel. A pre-specified interim futility analysis is planned for when 40% of progression-free survival events are observed, which is still anticipated later this year. I'd now like to briefly touch on effects of this performance. The AirMed team continues to make progress driving effects to adoption, generating sales of $2.5 million in the first quarter of 2026, compared with $1.4 million of sales in Q1 2025. resulting in $0.5 million of royalty revenue to BioLine Rx. We remain optimistic about the role that Effecsta can play in the new multiple myeloma treatment paradigm and look forward to continued growth in the future. Furthermore, recall that when we executed the AIRMID Outlicensing Agreement last year, they obtained not only the rights to commercialize Effecsta in stem cell mobilization for multiple myeloma, but also the rights to develop metixifortide across all other indications, excluding solid tumor indications, and in all territories other than Asia. This includes the evaluation of metixifortide in sickle cell disease. Indeed, ARAMID are continuing development of metixifortide in this indication and have previously reported encouraging results, and we are optimistic that this might contribute to future revenues given the high unmet need for better mobilization agents in this indication. The current standard of care mobilization agent, GCSF, is contraindicated in patients with sickle cell disease, so there is an urgent need for an agent that can reliably produce the exceptionally large quantities of stem cells that manufacturing and transplantation require in its indication, more than 20 million CD34 positive cells per kilogram, without further burdening already constrained aporesis capacities. Now let me turn the call over to Molly to provide a more detailed financial update. Molly, please go ahead.

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