BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLine RF third quarter 2022 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. For operator assistance during the conference, please press star zero. I would now like to turn over the call to John Lacey, head of corporate communications and investor relations. Please go ahead.

Thank you, operator. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. All statements in this conference call, other than historical facts, are indeed forward-looking statements. The words anticipate, believe, estimate, expect, intend, guidance, confidence, target, project, and other similar expressions are used typically to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance and may involve and are subject to certain risks and uncertainties and other factors that may affect BioLine RX's business, financial condition, and other operating results. These include, but are not limited to, the risk factors and other qualifications contained in BioLine RX's annual report on Form 20-F, quarterly reports filed in a 6-K, and other reports filed by BylineRx with the SEC to which your attention is directed. Actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. BylineRx expressly disclaims any intent or obligation to update these forward-looking statements. At this time, it is now my pleasure to turn the call over to Phil Serwin, Chief Executive Officer of BylineRx.

Thank you, John, and good morning, everyone. And thank you for joining us on our third quarter results conference call today. Earlier this morning, 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. As is our practice, I will begin with an overview of our third quarter, then Molly Zevi, our chief financial officer, will provide a discussion of our financial results. We will then open up the call and are looking forward to your questions. Also joining the call for Q&A are Abby Weinstein, our Chief Medical Officer, Ella Serrani, our Chief Development Officer, and Holly May, President of Violine Rx USA. The key highlight since our last quarterly update is unquestionably the submission and subsequent acceptance by the FDA of our new drug application for metixifortide, now known by its brand name Afexta, in stem cell mobilization for autologous bone marrow transplantation for multiple myeloma patients. The agency has assigned a PDUFA target action date at September 9, 2023. The NDA was based on the overwhelmingly positive topline results from our Genesis Phase III trial, which compared a FEXTA on top of GCSF versus placebo on top of GCSF. Recall that we held a successful pre-NDA meeting with the agency this past December and gained alignment on key aspects of the filing, most notably that a single phase three study genesis would be sufficient to support a submission. The study met all primary and secondary endpoints with a very high degree of statistical significance, a p-value of less than 0.0001. Notably, approximately 90% of patients in the genesis study went directly to transplantation after mobilizing the optimal number of stem cells following only one administration of Aphexa and in only one apheresis session. compared to less than 10% of those receiving GCSF alone. In addition, patients in the Effecsta plus GCSF arm collected a median of approximately 11 million stem cells per kilogram in only one aporesis session, versus approximately two million in the GCSF arm. The combination was also found to be safe and well tolerated. This high success rate has a substantial clinical benefit, especially when considering that new induction treatments are more effective than ever before, but cause subsequent difficulty in mobilizing the target number of stem cells for transplantation. The high success rate may also confer significant benefits to transplant institutions through the more efficient use of apheresis units, where there is often a lack of available machines. Given that the potential benefits of Afexda over the current standard of care accrue to multiple healthcare stakeholders, We anticipate rapid uptake in the market if and when approved. We plan to commercialize Effecsta in the U.S. independently. We have made this decision after a careful and lengthy review of our options, led by Holly May, president of our U.S. operations. Commercializing Effecsta ourselves will both accelerate its availability to multiple myeloma patients, while at the same time allow us to maximize the value of the asset for our company. Recall the third-party market research that we commissioned earlier this year concluded that in 2001, the U.S. stem cell mobilization market was approximately $360 million annually and growing steadily, and it was in excess of $500 million annually on a global basis. We have indicated before that the stem cell mobilization market is highly concentrated as approximately 80 transplant centers out of 212 perform approximately 80% of stem cell procedures. Therefore, the commercialization expenses and footprint required would be limited relative to a more traditional oncology launch in a broader indication. With our NDA now accepted, we look forward to working with the agency during its review process, while in parallel advancing our multifaceted pre-launch plan, including the ongoing build-out of U.S. infrastructure so that we are well-positioned for a robust launch if and when approved. To ensure that we are financially well positioned to execute the most effective launch possible, subsequent to the submission of our NDA, we announced the completion of two financings that in the aggregate give us access to up to $55 million of additional funds. First, we announced a $40 million non-diluted debt financing agreement with Creos Capital. Creos is a leading provider of innovative and flexible debt solutions. to equity-backed pan-European and Israeli high-growth companies in the technology and healthcare sectors. Per the terms of the agreement, the first tranche of $10 million was made available to us upon execution of the definitive agreement. The remaining $30 million will be made available in two additional tranches, subject to the achievement of pre-specified milestones. The tranches are available for drawdown at our discretion at various time points through October 1, 2024. Borrowings under the financing will bear interest at a fixed rate of 9.5% per annum, approximately 11%, including associated cash fees. And in addition, Krios would be entitled to mid- to high-single-digit royalties on effects to sales, up to a predefined cap. Following the close of the debt financing agreement, we also completed a $15 million registered direct equity offering of American depository shares. With the funds received from these transactions, our cash balance at September 30, 2022 was $57.3 million, which, including the additional potential amounts available to us under the debt financing agreement, we believe positions us very well financially to execute the targeted commercial launch that we are planning should effectively be approved. Turning now to our Metixifortide Pancreatic Cancer, or PDAC, program, Recall that earlier this year we entered into a development collaboration agreement with Genfleet Therapeutics. Under the terms of this agreement, Genfleet plans to execute a rigorously designed randomized phase 2B clinical study in approximately 200 first-line metastatic PDAC patients in China. Importantly, we maintain full rights to metixifortide across all indications and geographies, while GenFleet would be entitled to a small, single-digit sales royalty should Affecta ultimately be approved. This collaboration is based on the positive results that we reported from our Phase 2A Combat Keynote 202 triple combination study of metixiportide in combination with Merck's anti-PD-1 Keytruda and chemotherapy as a second-line therapy. As a reminder, data from the Phase IIa study demonstrated a substantial improvement across all study endpoints as compared to historical data, including median overall survival, median progression-free survival, confirmed overall response rate, overall response rate and disease control rate. Based on their development capabilities in China, including experience in conducting combination trials in the immuno-oncology space, We believe we have found the ideal partner to advance effects in pancreatic cancer and look forward to the initiation of this trial in 2023. Also recall that motixifortide is being evaluated in a separate investigator-initiated PDAC trial in collaboration with Columbia University. That Phase II study is evaluating motixifortide in combination with the anti-PD-1 libtio, and chemotherapy as a first-line PDAC therapy. That study continues to progress, and we will share additional updates, including the potential timing of data, which we hope will be during 2023 when available. Our presence at important medical congresses is key to raising awareness of the potential of metixifortide, and the American Society for Hematology meeting next month, December 10th through 13th, is perhaps the most important of the year. We are very pleased this year to announce two poster presentations at ASHE. The first presentation will detail full results from our pharmacoeconomic study that indirectly evaluated the cost effectiveness of using motixifortide as a primary stem cell mobilization agent in combination with GCSF versus plurixifor in combination with GCSF in multiple myeloma patients undergoing autologous stem cell transplantation. Data from the study demonstrated meaningful net cost savings with metixifortide plus GCSF due to a significantly greater proportion of patients in the metixifortide arm successfully achieving mobilization of the optimal amount of stem cells following a single administration of metixifortide and in only one aporesis session. The second presentation would detail the design of a phase one trial that will assess metixifortide as part of a novel stem cell mobilization regimen to evaluate its ability to safely produce the sufficient quantity of hematopoietic stem cells required for the genetic manipulation processes used in gene therapy development. The study will further examine the quality of the mobilized stem cells, including immunophenotypic and single cell transcriptional profiling. The trial will include patients with sickle cell disease, one of the most common inherited genetic diseases globally, and a condition where GCSF mobilization is associated with severe adverse effects. Plurixifor alone has not demonstrated an ability to reliably yield optimal hematopoietic stem cell numbers for gene therapy applications. We think gene therapy is just one example of how we can ultimately leverage metixifortide into additional high need indications. Turning now to our second clinical candidate, the intratumoral anti-cancer vaccine AGI-134. We are evaluating safety, tolerability, and proof of mechanism in multiple solid tumor types in a phase one two-way study. The study is designed to evaluate a wide array of biomarkers and assess both clinical and pharmacodynamic parameters. We believe that AGI-134 coats tumor cells with alpha-gal to make them look like foreign tissue to evoke an immune response that both destroys existing tumors and provides a vaccine-like effect. We anticipate sharing data from part two of the phase one to eight trial by year end. I would now like to turn the call over to Molly Zevi, our CFO, who will give a brief overview of our key third quarter financial statement items. Molly, please go ahead.