BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLine RX second quarter 2022 results conference call. All participants are presently in 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 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 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 20F, quarterly reports filed in the 6K, and other reports filed by BioLine Rx 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. BioLine Rx 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 Surlin, Chief Executive Officer of BioLine Rx.

Thank you, Tim, and good morning, everyone. And thank you for joining us on our second 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 second quarter, then Molly Zebi, 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, Elos Sarani, our chief development officer, and Holly May, our chief commercial officer. During the second quarter and subsequent period, we made significant progress across both our stem cell mobilization and pancreatic cancer programs for our lead compound, Motixivortide. At the same time, we were approaching a key data readout for our second program, the anti-cancer vaccine, AGI134, which I will discuss shortly. Turning to our most advanced opportunity, stem cell mobilization. In stem cell mobilization, we are nearing completion of our new drug application and anticipate submitting the package to the FDA within the next four to six weeks. 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. As a brief reminder, our Genesis Phase III trial of metixifortide 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 metixifortide on top of GCSF and in only one apheresis session. versus approximately 11% in the GCSF arm. In addition, patients in the motixifortide plus GCSF arm collected an average of 11 million cells per kilogram in only one apheresis session versus approximately two million in the GCSF arm. We believe the clear clinical advantage to patients of a significantly reduced number of apheresis sessions is quite compelling. While the high level of certainty regarding the number of apheresis sessions will enable more efficient utilization of apheresis units at transplantation institutions, where there is often a shortage of available machines. In contrast, the use of GCSF alone, one of the main current treatments for mobilization, generally requires multiple apheresis days 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. Not only does this add significantly to the cost of treatment, but it becomes logistically challenging to hospital apheresis units that, as just pointed out, are already quite burdened. Similarly, even with the addition of Plurixifortide to GCSF, which is the other main treatment in this indication, multiple administrations and apheresis sessions are generally required to achieve the target number of stem cells. Given that we have shown that Motixifortide on top of GCSF can achieve the target mobilization with a single administration of metixifortide and in a single aporesis session, the advantages of this combination over the existing treatment protocols are abundantly clear. In this regard, recall that we commissioned two pharmacoeconomic studies in the U.S. over the last year, 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 Team of IQVIA and 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 apheresis sessions, in turn driving benefits to the patients, the centers, and the 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, with lifetime estimates showing a net cost savings of approximately $19,000, not including the cost of Metixifortide, against GCSF alone. Against Plurixifor in combination with GCSF, IQVIA did a cross-study comparison, and these results even surpassed the economic benefits seen in the pharmacoeconomic study versus GCSF alone. with lifetime estimates showing a net cost savings of approximately $30,000, not including the cost of motixifortide for motixifortide plus GCSF versus plurixifor plus GCSF. I'd also like to take a moment to mention the extensive analyses that we have done to understand the addressable market for motixifortide in stem cell mobilization, including 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 US stem cell mobilization market was estimated at approximately $360 million and is continuing to grow. Globally, we believe the addressable market exceeds $500 million. 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 with a decreased ability to mobilize the target number of stem cells are being treated more frequently than in the past. 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 Plurixifor 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 remission rates, but on the other hand have negatively impacted stem cell yields, even with plurixifor, which on average requires more than two administrations and two aphoresis 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. Considering the totality of the data that we have compiled on motixifortide and stem cell mobilization, both clinical and pharmacoeconomic, we are confident that a very strong case can be made for motixifortide as part of a new treatment paradigm in stem cell mobilization for all multiple myeloma 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 I'd like to speak briefly about our pre-launch activities. In parallel to the NDA submission activities, we continue to evaluate all of our options with regard to the commercialization of Otixofortide in the U.S. 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. As part of our commercial preparedness, in June, we announced the appointment of Commercial Strategy and Operations Veteran Holly May as our new Chief Commercial Officer. In this newly created position, which is based in the U.S., Holly is responsible for the commercial planning, positioning, and launch oversight for Metixifortide in the Stem Cell Mobilization Indication across the U.S. market, assuming U.S. approval. We believe Holly is the perfect fit for this role, Her career trajectory has included 13 commercial launches, and she brings specific expertise in the hematopoietic stem cell mobilization area from her recent work in gene therapy. In addition, we have carried out a number of prelaunch activities with long lead times, such as engaging key vendors with expertise in the pricing and market access areas, initiating medical affairs activities, for example, institution profiling, medical materials, outreach to key stakeholders. drafting brand logo and artwork, and finally engaging commercial packaging organizations, serialization, and third-party logistics partners. We have indicated before that the stem cell mobilization market is highly concentrated. Approximately 80 centers 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. In addition, Holly's pre-existing relationships with the majority of these centers will serve us well. So, regardless of the manner in which we commercialize Motixifortide in the U.S., our efforts now will ensure that we are prepared for a robust launch next year that maximizes the value of the asset and ensures that Motixifortide is well positioned to capture a significant share of the estimated 360 million annual market opportunity in the U.S., In addition, as mentioned, our longer-term plans involve expanding metixifortide beyond multiple myeloma into additional indications. Turning now to our Metixifortide Pancreatic Cancer, or PDAC, program. In June, we took a significant step forward with this program by entering into a development collaboration agreement with Genfleet Therapeutics. Under the terms of this agreement, Genfleet will execute a rigorously designed randomized Phase IIb clinical study in approximately 200 first-line metastatic PDAC patients in China. Importantly, we maintain full rights to Motixifortide across all indications and geographies. While Genfleet would be entitled to a small single-digit sales royalty should Motixifortide ultimately be approved. This collaboration is based on the positive results that we reported from our Phase IIa Combat Keynote 202 Triple Combination Study of metixifortide 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 that we have found the ideal partner to advance metixiportide in pancreatic cancer, and we look forward to initiation of this trial in 2023. Regarding our second clinical candidate, the intratumoral anticancer vaccine, AGI-134, Recall that we are evaluating safety, tolerability, and proof of mechanism in multiple solid tumor types in the Phase I-IIa study. The study is designed to evaluate a wide array of biomarkers and assess both clinical and pharmacodynamic parameters. We hypothesized that AGI-134 coats tumor cells with alpha-gal to make them look like foreign tissue in order to evoke an immune response that both destroys existing tumors and provides a vaccine-like effect. We hope to successfully demonstrate this mechanism of action when we read out top-line results from Part 2 of the study. We are on track to do so later this year. If positive, we plan to initiate a Phase 2 study in 2023. I would now like to turn the call over to Molly Zevi, our CFO, who will give a brief overview of our key second quarter financial statement items. Molly, please go ahead.