BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx fourth quarter 2021 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 the call over to Tim McCarthy of LifeSciAdvisors. 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 BioLineRx's business, financial condition and other operating results. These include but are not limited to the risk factors and other qualifications contained in BioLineRx's annual report on Form 20F, quarterly reports filed in the 6K and other reports filed by BioLineRx 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. BioLineRx 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 Mr. Phil Serlin, Chief Executive Officer of BioLineRx.

Thank you, Tim, and good morning, everyone. And thank you for joining us on our fourth quarter and annual 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. I will begin with an overview of our very busy fourth quarter and year and explain why we are so excited about our prospects for 2022 and beyond. Then Mali Zeevi, 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, and Ella Sorani, our Chief Development Officer. The past several months, perhaps more than any other in our company's history, has truly been a transformational period as we strengthen and elucidate the compelling profile of Motyxoportyte in stem cell mobilization, which we believe will be BioLineRx's lead growth driver moving forward. A pivotal event for our team was the successful pre-new drug application or pre-NDA meeting that we had with the FDA in mid-December to obtain agreement from the agency that our single phase three genesis study would be sufficient to submit an NDA for metixifortide as a stem cell mobilization agent for autologous bone marrow transplantation in multiple myeloma patients. As a brief reminder, in May 2021, We announced positive top-line results from our Genesis Phase III trial of motixifortide and stem cell mobilization. The study met all primary and secondary endpoints with a very high degree of statistical significance, a p-value of less than 0.0001. Approximately 90% of patients went directly to transplantation after mobilizing the optimal number of stem cells following only one administration of metixifortide and in only one aporesis session. In addition, patients in the metixifortide plus GCSF arm collected in only one aporesis an average of 11 million cells per kilogram versus 2 million in the GCSF arm alone. In this regard, the availability and subsequent infusion of a higher number of stem cells has the potential to significantly shorten the time to engraftment. Moreover, we believe that higher levels of certainty regarding the number of aporesis sessions required for mobilization enables more efficient utilization of aporesis units at transplantation institutions, where there is often a shortage of available machines. Needless to say, we were very pleased that during our meeting, the FDA agreed that our proposed data package would be sufficient to support an NDA submission. We received formal feedback from the agency in January, and we are working diligently to finalize the package and intend to submit around midyear. We recognize that future adoption of Motixifortide, if approved, will be driven primarily by its differentiated clinical efficacy and safety profile, yet other important factors will be considered by key stakeholders, namely the ability to positively and efficiently deliver improvements and savings to the healthcare system. Our two pharmacoeconomic studies versus the current two main treatment options, GCSF alone and Plurixifor on top of GCSF, highlight Motixifortide's key ability when combined with GCSF to optimize the mobilization and collection of stem cells and therefore reduce the number of apheresis sessions, in turn driving benefits to the patients, centers, and payers. Both of these studies were performed by the Global Health Economics and Outcomes Research, HEOR, team of IQVIA, one of the leading global providers of advanced analytics, technology solutions, and clinical research in the biotech pharma industry. Beginning with the pharmaeconomic study that we ran as part of our Phase III Genesis study, last quarter we highlighted the significant positive results that were demonstrated comparing metixifortide plus GCSF to GCSF alone. for the mobilization of stem cells in multiple myeloma patients undergoing autologous stem cell transplantation. The pharmacoeconomic study analyzed healthcare resource utilization, HRU, observed during the Genesis trial in each of the two randomized arms, Motixifortide in combination with GCSF and placebo in combination with GCSF. Metixifortide plus GCSF was associated with a statistically significant HRU decrease during the autologous stem cell transplantation process compared to GCSF alone. Given the higher number of mobilized cells and the lower number of aparesis sessions, lifetime estimates showed quality-adjusted life here were quality benefits and net cost savings of $19,000, not including the cost of Metixifortide, versus the current standard of care. We also wanted to answer the key question of how motixifortide provides benefit over the other main treatment option, plurixifor on top of GCSF. And in this respect, a study comparing motixifortide plus GCSF to plurixifor plus GCSF on an indirect basis using standard methodologies to do cross-study comparisons was performed by IQVIA as well. These results reinforced and surpassed the economic benefits previously seen in the pharmacoeconomic study evaluating metixifortide in combination with GCSF versus GCSF alone. Based on a significantly higher number of mobilized cells and a lower number of aparesis sessions, in this study, lifetime estimates showed quality-adjusted life year quality benefits and net cost savings of approximately $30,000, not including the cost of metixifortide. for Metixifortide plus GCSF versus Plurixifor plus GCSF. So we have now demonstrated a very compelling pharmacoeconomic case against both of the main treatment options in stem cell mobilization for multiple myeloma patients, GCSF alone and the market-leading regimen of Plurixifor on top of GCSF. We believe that the compelling cost savings identified by these rigorously designed studies strongly support our view that motixifortide in combination with GCSF can become the new standard of care for all multiple myeloma patients undergoing autologous stem cell transplantation at all treatment centers. Together with the data from the GENESIS trial showing that nearly 90% of patients collected an optimal number of cells for transplantation following a single administration of metixivortide and in only one aporesia session versus less than 10% for GCSF alone, The pharmacoeconomic studies provide a strong commercial case for the use of metixifortide on top of GCSF and should leave substantial room in the future to optimize our pricing strategy for metixifortide at product launch and thereafter if approved. Further looking ahead, we believe that our product has the potential to expand beyond multiple myeloma to other indications, such as non-Hodgkin's lymphoma, sickle cell anemia, and others. And speaking of the Genesis study, we were fortunate to be able to highlight the results of the study in an oral presentation during the American Society of Hematology Annual Meeting and Exposition, or ASH, held in December. The presentation, delivered by Dr. Zachary Kreese from the Washington University School of Medicine in St. Louis, expanded upon the unmet need that exists in stem cell mobilization. Specifically, he noted that in two previously published plurixivor trials, Between 15 and 35% of patients still fail to yield optimal stem cell yields of over 6 million CD34 positive cells per kilogram, even with up to four apheresis sessions. Additionally, it was noted that advances in modern induction therapies for multiple myeloma patients have made the harvesting of a sufficient number of stem cells even more challenging, a trend that is expected to continue in the future. Taken together, this points to a clear need for new and improved mobilization therapies, and we believe Motixifortide is well positioned to fill this need if approved. Needless to say, we were delighted to have such a meaningful presence at one of the most important oncology meetings in the industry. At this point, I would like to provide an overview of the stem cell mobilization market opportunity in the U.S. There are over 20,000 hematopoietic stem cell transplantations annually in the U.S., approximately 60% of which are autologous. Autologous transplants have shown continuous growth over the last several years. Within the U.S. stem cell mobilization market, multiple myeloma represents the largest opportunity, approximately 58% of all autologous transplants. To put this in context, this means that one in every three stem cell transplantations in the US is for multiple myeloma patients. The need for improved mobilization agents in recent years has been exacerbated by the introduction of more effective induction therapies, which have positively impacted outcomes but negatively impacted stem cell yields. As mentioned, the current treatment options are either GCSF or Plurixifor plus GCSF, both of which often require multiple administrations and multiple aporesis sessions to mobilize the minimum number of cells for transplant. A recent market assessment which we commissioned through a third-party vendor, ZS Associates, estimates the value of the U.S. stem cell mobilization market at approximately $360 million in 2021. This market will continue to grow as we see increased upfront use of the plurixifor Plurixivir plus GCSF combination therapy drives stem cell mobilization, especially in multiple myeloma patients. The Plurixivir unit and dollar volume performance in the US over the past few years indicates increased use of the product in stem cell transplants. Based on our assessments, Plurixivir plus GCSF continues to gain traction in the autologous stem cell transplant setting, especially for multiple myeloma patients. In this regard, we believe that based on differentiated clinical data coupled with favorable pharmacoeconomic data, Motixa 4-type plus GCSF has the potential to be the new standard of care for stem cell mobilization in patients undergoing autologous stem cell transplantation. As we move through the regulatory process and continue to de-risk the asset, We are mindful of the need to begin planning now for the eventual commercialization of montixoportide in stem cell mobilization if approved. We have done extensive analysis to understand the market opportunity, including the pharmacoeconomic study and detailed third-party market assessment just referenced. What we have determined is that there is a significant unmet need for a more efficacious stem cell mobilization agent in multiple myeloma. One that enables the collection of the required number of cells for transplant with fewer administrations and fewer aporesis sessions. The opportunity is very focused and concentrated as approximately 80 transplant centers out of 212 across the United States perform roughly 80% of all stem cell transplant procedures. Therefore, the commercialization expenses and footprint required would be limited relative to a more traditional oncology launch in a broader indication. Given this dynamic and being highly encouraged with this unique opportunity in the U.S., we are maintaining optionality with respect to the launch of Metixifortide either with a partner or a loan and will ultimately do what allows us to extract the most value from this asset in the U.S. and globally. Regardless of the route taken, however, we are planning for an aggressive launch to ensure rapid uptake and have initiated pre-launch activities that would be required under any scenario. We are thrilled to potentially introduce, in 2023, the first real advancement in stem cell mobilization since the approval of Plurixifor in 2008. Turning now to our Metixifortide Pancreatic Cancer, or PDAC program, Recall that we previously announced positive final results from the Phase 2A Combat Keynote 202 triple combination study of metixoportide in combination with Merck's anti-PD-1, Keytruda, and chemotherapy as a second-line therapy. A total of 43 patients initially diagnosed with unresectable stage 4 metastatic PDAC who had progressed following first-line gemcitabine-based therapy were enrolled. Data from this 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. With regard to next steps for our PDAC program, as we've previously indicated, we continue to engage in discussions with the potential biopharma partners with the goal of collaborating on a randomized controlled Phase 2-3 study. Regarding our second clinical candidate, the intratumoral anti-cancer vaccine, AGI134, recall that we are evaluating safety, tolerability, and proof of mechanism in multiple solid tumor types in a Phase I-IIa study. The study is designed to evaluate a wide array of biomarkers and assess both clinical and pharmacodynamic parameters. In September 2019, we announced positive safety data, and later that same month, we moved quickly to initiate Part 2, the dose expansion phase. Just a few weeks ago, we were very pleased to announce that we have now completed enrollment in Part 2, despite some COVID-related delays along the way, and we plan to announce the Phase 1 two-way study readout in the second half of this year. to provide insight and guidance on the company's activities in the field of immuno-oncology. In December, we announced the formation of an immuno-oncology scientific advisory board, or SAB. The board is comprised of highly regarded thought leaders in the fields of immuno-oncology, intratumoral injections, and clinical development, each of whom brings unique experience and perspectives that will prove invaluable as we continue to advance our immuno-oncology pipeline through later stage clinical development. We are pleased to have been able to assemble such an esteemed group of experts in the field and we look forward to their continued contributions. I would now like to turn the call over to Mali Zeevi, our CFO, who will give a brief overview of our key fourth quarter financial statement items. Mali, please go ahead.