BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx third quarter 2024 financial results conference call. All participants are presently in a listen-only mode. Following management's formal presentation, instructions will be given for the question and answer session. I would now like to turn over the call to John Lacey, head of investor relations and corporate communications. John, please go ahead.

Thank you, operator. Welcome, everyone. Thank you for joining us on our third quarter 2024 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've made 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 Serwin, Chief Executive Officer of BylineRx.

Thank you, John, and good morning, everyone. And thank you for joining us on today's call. I'll begin this morning with a recap of the significant licensing agreement that we announced last week with AirMid Limited, followed by a review of our third quarter performance, and then Molly Zevi, our Chief Financial Officer, will briefly recap our financials. Afterwards, we will take your questions. Ellis Serrani, our Chief Development Officer, is also available for Q&A. Last week, we announced that we executed an exclusive license agreement with AirMid Limited, the parent company of Gameta Cell Limited for Motexifortide, which is sold in the U.S. under the brand name Afexta. Recall that Afexta is our FDA-approved and commercially available stem cell mobilization agent, indicated in combination with GCSF for the collection and subsequent autologous transplantation in patients with multiple myeloma. The agreement covers all indications with the notable exception of solid tumors like pancreatic ductal carcinoma, or PDAC, and all territories with the exception of Asia, where we previously entered into a license agreement with Gloria Biosciences for Metixifortide in that region. This transaction is very beneficial for BioLine RX, with a $10 million upfront payment, $87 million in potential commercial milestones, and very healthy royalties of between 18 and 23%. In addition, we received another $9 million in the form of an equity investment from Highbridge Capital. This aggregate cash influx has enabled the company to finalize an agreement with BlackRock to repay a significant portion of its outstanding debt and restructure the remaining debt on favorable terms. With the transfer of our commercial program to AirMid GametaCell, we have also reduced our cash burn in a very substantial manner, with our cash runway now extending into 2026. And I will provide more financial details about this shortly. Lastly, the agreement allows us to return to our drug development roots with a streamlined organization that has a proven track record in clinical development and regulatory affairs. To that end, we will continue to support development of metixifortide in metastatic pancreatic cancer through our existing collaborations, which have the potential to create near-term value for shareholders. Over the next year, we also plan to evaluate early-stage clinical assets in the areas of oncology and rare disease. where we think we can leverage our expertise in complex drug development and create long-term shareholder value. We believe the choice of Gametacel as our commercial partner is a fortuitous one. Gametacel adds a highly differentiated mobilization agent, Inifexa, to a commercial portfolio that already includes AmiSearch, the first and only FDA-approved NAM-modified cell therapy for patients with hematologic malignancies in need of an allogeneic hematopoietic cell transplant. We envision GametaCell meaningfully growing effects to sales by leveraging its portfolio for improved access to its transplant center customers. As part of this transaction, GametaCell is seeking to transition a significant number of former members of the BioLine Rx commercial team who have been so instrumental in the early commercial success of Effecsta, driving penetration to over 40% of our target centers and capturing 10% of the market at the end of Q3. In addition, recall that Effecsta is also being evaluated in patients with sickle cell disease undergoing gene therapy, with two phase one investigator-initiated trials ongoing. one at Washington University in St. Louis and the other at St. Jude Children's Research Hospital. We view this as another opportunity for long-term value creation. Quickly reviewing the terms of the agreement, in exchange for the license, we received a $10 million upfront payment. We also are eligible to receive up to an additional $87 million of potential commercial milestones, plus royalties on net sales of effects ranging from 18% to 23%. We will also supply Metixa Fortide on a cost plus basis, both for commercial and development supply. In addition, certain funds managed by Highbridge Capital Management have made a $9 million equity investment in BioLineRx. This equity investment and the combined future potential commercial milestones from licensing agreements with Aramid and Gloria Biosciences, as well as royalties on net sales, are expected to provide a strong foundation for our company. Looking now at the new BioLine RX, concurrent with the partnering transaction, we are shutting down our U.S. commercial operations. I would like to thank Holly May, who headed our U.S. commercial operations, for her tireless commitment to building a world-class team and ensuring a successful launch. It is largely due to her efforts that we are experiencing strong momentum for Afexta, particularly among top-tier transplant centers, that are leaders with respect to installing new therapies on formulary and into daily clinical practice. This transformation, along with additional cost reductions, will allow us to reduce our annual cash burn by more than 70% effective January 1st, 2025, and refocus our efforts on clinical development in Israel. With the proceeds from this transaction, we entered into an agreement with BlackRock to repay $16.5 million of the approximately $29 million in outstanding debt, with the remaining balance restructured at terms very favorable to our company, including at the pre-existing annual interest rate of 9.5%. With potential revenue from two licensing agreements, together with a significantly streamlined organization, with a greatly reduced cost structure and restructured debt, we are very well positioned to advance our near and long-term value creation strategy for investors. At this point, I'd like to review our PDAC program, which we continue to advance through our existing collaborations that require de minimis investment. Recall that motixifortide is an inhibitor of CXCR4, which plays a critical role in establishing and maintaining tumors. It is highly expressed in over 20 different tumor types, and it is estimated that greater than 70% of PDAC patients show an overexpression of CXCR4. PD-1 and PD-L1 inhibitors have demonstrated significant efficacy in multiple solid tumor types, but no survival benefit in a large randomized PDAC trial comparing combination immunotherapy and standard of care chemotherapy versus standard of care chemotherapy alone. In contrast, a phase two trial in second line patients with metixifortide plus PD-1 inhibitor plus standard of care chemotherapy demonstrated improvements across all study endpoints. So while PDAC is an inherently challenging cancer to treat, there is very strong scientific and clinical rationale for continued development. Motixifortide is being evaluated in an active phase 2B study led by Columbia University known as Chemo4MetPank, which is supported equally by BiolineRx and Regeneron. Recall that this trial had an initial pilot phase, and based on the results of this pilot phase, an assessment would be made on advancing to an expansion phase of the study. Seven of 11 patients in the pilot phase, or 64%, experienced a partial response, of which five were confirmed PRs as of the July 2023 cutoff date, with one patient experiencing complete resolution of the metastatic lesion in the liver. Along with the three patients, or 27%, experiencing stable disease, This resulted in a disease control rate of 91%. These findings compare favorably to historic partial response and disease control rates of 23% and 48%, respectively, reported with the current standard of care. Based on these compelling data, we, along with Columbia and Regeneron, agreed to amend the original expansion phase of the study from a single arm expansion study with a target enrollment of 30 patients to a much larger randomized phase 2B study of 108 patients with two arms. Metixifortide, Regeneron's PD-1 inhibitor simiplimab, and standard of care chemotherapy versus standard of care chemotherapy alone. The trial's primary endpoint is progression-free survival. Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit, and overall survival. To further accelerate enrollment, Columbia plans to activate an additional three trial sites over the next two quarters, in addition to the two that are currently enrolling. We anticipate that the trial should be fully enrolled by 2027. Metixifortide is also planned to be evaluated in a planned Phase IIb PDEC study in China, led by Gloria Biosciences, pursuant to the license agreement that we signed with Gloria in October of last year. That study will evaluate metixifortide in combination with Gloria's commercially approved PD-1 inhibitor, Zimbarilumab, and standard of care combination chemotherapy in first-line pancreatic cancer. The opportunity for us to help patients in dire need of effective new treatment options while addressing a multi-billion dollar market opportunity is significant. PDAC is a very difficult cancer to treat given that it is often asymptomatic until stage four. It has the highest mortality rate among solid tumor malignancies. Globally, nearly half a million people were diagnosed with PDAC in 2020 alone. We look forward to keeping you up to date on our progress in this important program. Now I'd like to briefly review some key performance indicators for Effecsta during the third quarter, as I believe they reflect the many benefits to transplant centers and patients that key decision makers are increasingly realizing particularly as they pertain to center efficiency and economics. As we've noticed previously, transplant centers, the end users of Effecsta, are a well-defined group in the U.S. Approximately 80 of the 212 centers in the U.S. perform roughly 85% of all transplant procedures. Among those 80 centers, by the end of the third quarter, we secured formulary placement at institutions managing over 40% of transplant procedures. We also continued to see steady growth in the number of centers reordering product. Furthermore, we saw an approximate 40% increase in the number of institutions ordering effects during the third quarter as compared to the second quarter. As the third quarter was only the third full quarter since launch, we are very pleased with the traction that we've seen, especially with the availability of Plurix A4 or generic Mozabil, which entered the market shortly before our launch. In fact, During the third quarter, we achieved a 10% market share milestone of total CXCR4 inhibitor usage in the U.S., which compares Afexda to branded Mozaville and generic Plurixifor across all indications. We believe that this strong growth trajectory will continue through GametaCell's commercial program, building on the strong foundation in place. As we have discussed on prior conference calls, there are a number of factors that are driving the need for more effective mobilization regimens. First, multiple myeloma patients are getting older, and these patients are more challenged to achieve the required stem cell yields for transplantation. In addition, the growing use of quad induction therapies, while beneficial to patients, can negatively impact stem cell yields. Last quarter, we cited the Perseus trial, in which a recent FDA-approved quad therapy was shown to reduce risk of disease progression or death in multiple myeloma patients by 60%. pointing to the trend toward quad therapies as a new standard of care induction therapy. It is against this backdrop of a rapidly changing SAMHSA mobilization treatment landscape that we believe Afexta can address significant unmet needs in the market. We are pleased to have entrusted its future success to an ideal partner like GametaCell with the expertise and infrastructure to maximize Afexta's commercial potential. Now let me turn the call over to Molly to provide a financial update. Molly, please go ahead.