BioLineRx Ltd.

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 report on Form 20-F, quarterly reports filed in a 6-K, and other reports filed by BioLineRx with the SEC to which your attention is directed. Actual outcomes and results may differ severely from what is expressed or implied by this report. BioLineRx expressly claims 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 Serlin, Chief Executive Officer of BylineRx.

Thank you, John, and good morning, everyone. Thank you for joining us on our full year 2022 financial 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, 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 on the call for Q&A are Tommy Rachmilevich, MD, our new Chief Medical Officer, Ella Sorani, our Chief Development Officer, and Holly May, President of BioLineRx USA. I want to begin this morning with an update on our lead program for Motixifortide, now known by its trade name Afexta, in stem cell mobilization for autologous transplantation in multiple myeloma patients. Recall that in November, we announced that the FDA had accepted our new drug application for Afexta in stem cell mobilization and assigned a PDUFA target action date of September 9, 2023. The NDA was based upon our very successful Genesis Phase III clinical trial, which met all primary and secondary endpoints with a very high degree of statistical significance. The combination was also found to be safe and well-tolerated. Notably, nearly 90% of patients treated in the AFEXTA arm collected an optimal number of cells for transplantation following a single administration of AFEXTA plus GCSF and in only one aparesis session. These results were superior to GCSF alone. In addition to potentially improving transplant experiences for patients, we believe the use of metixifortide as a standard of care mobilization agent would confer significant benefits to transplant centers as well. And to that end, we presented full results from a pharmacoeconomic study of metixifortide at the 64th American Society of Hematology, the ASH annual meeting, which was held in December. The study indirectly evaluated the cost effectiveness of using metixifortide as a primary stem cell mobilization agent in combination with GCSF against plurixifor in combination with GCSF in multiple myeloma patients undergoing autologous stem cell transplantation. The analysis demonstrated significant net cost savings using metixifortide plus GCSF with a greater proportion of patients achieving successful mobilization of optimal amounts of stem cells in a single aporesis state. This in turn allows transplant centers to make more efficient use of the apheresis units, which are often in short supply. As we have indicated several times in the past, market research that we commissioned concluded that the stem cell mobilization market represents a $360 million opportunity in the U.S. and $500 million globally and growing steadily. There are many drivers of this growth, but older patients undergoing stem cell transplantation together with more effective induction regimens are making subsequent mobilization of an adequate number of stem cells required for transplantation quite challenging. Given that a large majority of stem cell transplant procedures in the U.S. are conducted at a relatively small number of key sites, approximately 80 transplant centers out of 212 perform approximately 80% of stem cell procedures, we announced in September of last year that we plan to commercialize Effecsta independently. We evaluated a number of different go-to-market strategies, and we believe commercializing independently puts us in the best position to speed the drug's availability to patients through very focused outreach to these centers, thus maximizing the value of the asset for our company. Looking at the total of efficacy, safety, and tolerability and pharmacoeconomic data that we have compiled on Effecsta in stem cell mobilization to date, We are very hopeful that it will ultimately be approved and in anticipation of that, we have been extremely busy moving ahead with critical pre-launch activities. In particular, while the agency has been reviewing our NDA and in advance of our September 9th PDUFA date, we've been building out our U.S. commercial infrastructure, including the assembly of a world-class commercial team. In June of last year, we announced the addition of Holly Mae, who leads our U.S. activities. Holly's background includes more than a dozen career commercial launches, including specific expertise in stem cell mobilization and gene therapies. This experience will prove invaluable, not only as we prepare to launch Effecsta in stem cell mobilization, but also for our lifecycle management activities, which I will discuss in a moment. More recently, we were also very pleased to hire hematology and transplant commercial veteran, Kevin Gamble, as head of U.S. sales and market development. Kevin has the ideal background and skill set for this role, having previously served as head of transmit at Sanofi, where he led a 23-person commercial team whose portfolio included Plurixa4 for stem cell mobilization. Before that, he served as U.S. marketing director for Plurixa4 at Genzyme until the acquisition of that company by Sanofi in 2011. Given the steady growth and expanding use of Plurixifor, we believe Kevin is the ideal person to help make Afeksta the new standard of care mobilization agent, initially for multiple myeloma patients undergoing autologous stem cell transplantation and potentially for other indications as well. Along with Kevin, we've also added a number of very qualified and experienced individuals to lead critical commercialization functions such as supply chain, marketing, market access, patient advocacy, and field medical affairs. We're extremely fortunate to have added many, many decades of very relevant and specific expertise to our U.S. team, and I believe we have the ideal personnel to execute a successful commercial launch. We also announced a key addition at the corporate level with the hiring of Dr. Tommy Rachmilevich as our new Chief Medical Officer. Tommy brings to our team many years of experience overseeing clinical development programs across a wide range of therapeutic areas and drug development modalities, including oncology, immunology, and neurodegeneration. Her expertise will be invaluable to advance the NDA review process, expand Metixifortide's clinical development, into additional therapeutic areas, assess our next clinical development steps for AGI-134, and add new assets to our development pipeline. Turning now to our second clinical program for metixivortide, metastatic pancreatic cancer, or PDEC. Recall that metixivortide is being evaluated in an investigator-initiated metastatic PDEC trial in collaboration with Columbia University. That Phase 2 study is evaluating Metuxifortide in combination with the anti-PD1 Liptio and standard of care chemotherapy in first-line metastatic PDAC patients. That study continues to progress and we anticipate data from the first cohort of patients this year. We also previously announced a collaboration with Genfleet Therapeutics pursuant to which Genfleet will execute a rigorously designed randomized Phase 2B clinical study assessing metixifortide in combination with a PD-1 inhibitor and standard of care chemotherapy in approximately 200 first-line metastatic PDAC patients in China. The collaboration follows the positive results that we reported from our Phase IIa Combat Keynote 202 triple combination study of metixifortide in combination with the anti-PD-1 Keytruda and chemotherapy in second-line patients. 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. We anticipate that the GenFleet Phase 2b trial will initiate by the end of this year. In addition to our two core clinical programs just mentioned, we are also working to evaluate Metixifortide's clinical utility and additional high unmet need indications. One of these is hematopoietic stem cell mobilization for gene therapies in sickle cell disease. Sickle cell disease is one of the most common genetic diseases globally. It is typically diagnosed early, around six months of age. The clinical manifestations of sickle cell disease include anemia and blood vessel occlusion which can lead to both acute and chronic pain as well as tissue ischemia across multiple organ systems. The cumulative impact of these complications significantly impacts morbidity and mortality for patients with sickle cell disease. Autologous hematopoietic stem cell based gene therapies now offer curative potential for patients with sickle cell disease. but they are dependent upon the collection of significant quantities of stem cells including early progenitor stem cells. The common mobilization agent, GCSF, is contraindicated in patients with sickle cell disease, significantly limiting their stem cell mobilization options. The development of novel mobilization regimens has the potential to overcome this unmet need for patients. Recognizing the clear unmet need for a more effective mobilization regimen and leveraging our work in stem cell mobilization, we entered into a clinical trial collaboration with the Washington University School of Medicine to evaluate Motixifortide for stem cell mobilization in sickle cell disease. The trial, which is expected to launch in 2023, will evaluate Motixifortide both as monotherapy and in combination with natalizumab.

This represents a very logical expansion of our development pipeline.