BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx first 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 the call over to Tim McCarthy of LifeSci Advisors. 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 first 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. I will begin with an overview of our first quarter, 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. Joining the call as well for Q&A are Abby Weinstein, our Chief Medical Officer, and Ella Sorani, our Chief Development Officer. I'll start with a brief introduction. As we approach the most important milestone of the company's history, we are increasingly optimistic about the potential of Metixifortide as part of a new treatment paradigm in stem cell mobilization for multiple myeloma patients, physicians, and transplant centers. Driven by this enthusiasm, we have been working tirelessly to both prepare our new drug application and to position this therapy for a robust and successful commercial launch in 2023, if approved. Moving on to the NDA submission. As mentioned, we are moving forward aggressively and efficiently with the completion of our NDA and remain on target for a mid-year submission consistent with what we have stated previously. Recall that in mid-December of last year, we held a pre-NDA meeting with the FDA to obtain agreement from the agency that our single phase three genesis study would be sufficient to submit an NDA for motixifortide as a stem cell mobilization agent for autologous bone marrow transplantation in multiple myeloma patients. Needless to say, we were very pleased that the FDA agreed that our proposed data package would be sufficient to support an NDA submission. Based on our projected timelines regarding a submission in the next few months, this would likely point to a commercial launch of Motixifortide in 2023 should it be approved. As a brief reminder, our Genesis Phase III trial of Motixifortide in stem cell mobilization 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 underwent transplantation after mobilizing the target number of stem cells following only one administration of motixifortide and in only one aphoresis session. In addition, patients in the motixifortide plus GCSF arm collected an average of approximately 11 million stem cells per kilogram in only one aphoresis session versus approximately 2 million in the GCSF arm. This compelling data and specifically the high level 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. Now let me turn to our prelaunch activities. In parallel to the NDA submission activities, We continue to evaluate all of our options with respect to the commercialization of Motixifortide in the US. In this regard, we are advancing a broad range of pre-launch activities that would be required under any commercialization scenario, whether we commercialize with a partner or independently. Our goal is to be prepared for launch on time and to facilitate the rapid uptake of metixifortide. As we indicated last quarter, this 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. Thank you for watching. Let me now speak a little bit about a market assessment. As we indicated last quarter, we have done some extensive analysis to understand the addressable market for Metixifortite in stem cell mobilization. This includes a market assessment that we commissioned through a well-respected third-party vendor, ZS Associates. The conclusion is that in 2021, the value of the U.S. stem cell mobilization market was estimated at approximately $360 million and is continuing to grow. Globally, we believe the addressable market exceeds $500 million. There are over 20,000 hematopoietic stem cell transplantations annually in the U.S., approximately 60% of which are autologous, and this number has 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. Historically, GCSF alone was the primary agent used to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent transplantation. However, the use of GCSF generally requires multiple apheresis stays to reach the target number of cells for collection, and in a substantial number of instances, there are still patients who remain unable to produce the target number of cells for autologous transplantation. Furthermore, the need for multiple apheresis sessions increases healthcare costs and is a logistical burden to the already busy apheresis units, in addition to the fact that it causes an increase in the adverse events related to apheresis procedures. With the advancement of new induction treatment regimens for multiple myeloma patients, which generally include multiple therapeutic compounds within the combination, the subsequent risk of mobilization failure continues to increase. To date, higher intensity three or four drug regimens have become the standard of care induction treatment for all autologous stem cell transplant eligible patients. Recent data have demonstrated that use of such higher intensity induction treatments can lead to impairment of stem cell mobilization. In addition, age is a predictor of stem cell mobilization response, and elderly patients are being treated more frequently than in the past. Mali Zeevi, Ella Sorani, John Lacey, Philip Serlin, Raziel Fried to approximately 8,000 in 2019, with patients aged 65 and over comprising 22% of total patients in 2009 and increasing to 36% of total patients in 2019. Based on the above need for better mobilization agents, Growth in this market over the last few years has been driven by the increased upfront use of the Plurixa 4 Plus GCSF combination therapy to drive stem cell mobilization, especially in multiple myeloma patients. The plurixifor unit and dollar volume performance in the U.S. over the past few years indicates increased use of the product in stem cell transplants. And as mentioned, this dynamic has been exacerbated in recent years by the introduction of more effective and aggressive induction therapies, which on the one hand have had higher initial response, and RemissionRates, but on the other hand have negatively impacted stem cell yields even with Plurixa4, which on average requires at least two administrations and two apheresis sessions in order to reach the target mobilization. This trend highlights the ever-increasing need for a better and more potent mobilizer and we believe that is Motixifortide. In this regard, we believe that based on its differentiated clinical data, coupled with its favorable pharmacoeconomic data, which we will recap in a moment, Motixifortide plus GCSF has the potential to gain a significant share of the market and become the new standard of care for stem cell mobilization in patients undergoing autologous stem cell transplantation. In addition, longer term, we believe that our product has the potential to expand beyond multiple myeloma to other indications. Now let me briefly talk about our pharmacoeconomic studies. At this point, I will briefly mention the two studies we commissioned, one comparing metixifortide against GCSF and the second comparing metixifortide against plurixifor. Both of these studies were performed by the Global Health Economics and Outcomes Research, or HEOR, team of IQVIA, one of the leading global providers of advanced analytics technology solutions and clinical research in the biotech pharma industry. So they were rigorously designed and executed. Both studies identified significant cost savings from using Motixifortide, driven by its ability to optimize the mobilization and collection of stem cells, and therefore reduce the number of aporesis sessions, in turn driving benefits to the patients, centers, and payers. Against GCSF alone, Motixifortide plus GCSF was associated with a statistically significant decrease in health resource utilization during the autologous stem cell transplantation process. Thank you very much. even surpassed the economic benefits seen in the pharmacoeconomic study versus GCSF alone. In this study, lifetime estimates showed a net cost savings of approximately $30,000, not including the cost of metixifortide for metixifortide plus GCSF versus plurixifortide plus GCSF. We believe that the compelling clinical data from our Phase 3 Genesis trial, as well as the compelling cost savings identified by these studies, strongly support our view that Metixifortide 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 previously mentioned from the Genesis trial, showing that nearly 90% of patients collected an optimal number of cells for transplantation, following a single administration of metixifortide and in only one aphoresis 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 to optimize our pricing strategy for metixifortide at product launch if approved. Now let me briefly talk about our pancreatic cancer study. Turning now to metixifluorotide pancreatic cancer, or PDAC program, recall that we previously announced positive final results from the Phase 2A Combat Keynote 202 triple combination study of metixifluorotide 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 four metastatic PDAC who had progressed who had progressed following first-line gemcitabine-based therapy were enrolled. As a reminder, 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 the next steps for our PDAC program, as we've previously indicated, we continue to engage in discussions with potential biopharma partners with the goal of collaborating on a randomized controlled Phase IIb study. Turning to AGI-134 now. Regarding our second clinical candidate, the intratumoral anti-cancer vaccine, AGI-134, recall that we are evaluating safety, tolerability, and proof of mechanism in multiple solid tumor types in a Phase I two-way 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. We have now completed enrollment in Part 2, and we plan to announce the Phase 1 two-way study readout in the second half of this year, consistent with our prior guidance. To help advance this and other company activities in the field of immuno-oncology, and specifically with regard to AGI-134, in December we announced the formation of an Immuno-Oncology Scientific Advisory Board, or SAB. This advisory board is comprised of highly regarded thought leaders in the fields of immuno-oncology, intratumoral injections, and clinical development, and we are already benefiting from their unique experience and perspectives. 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.