BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx third quarter 2023 financial 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 John Lacey, Head of Investor Relations and Corporate Communications. John, please go ahead.

Thank you, Johnny. Welcome, everyone. Thank you for joining us on our third quarter 2023 results conference call. Earlier today, we issued a press release, a copy of which is available in the investor relations section of our website. We've also filed a B6K. I'd like to remind you that certain statements we make during the call will be forward-looking. Because such statements deal with future events and are subject to many risks and uncertainties, Actual results may differ materially from those in the four different statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 20-F and our quarterly reports on Form 6-K that are filed with the U.S. Securities and Exchange Commission. At this time, it is now my pleasure to turn the call over to Mr. Phil Terland, Chief Executive Officer of BioLine RA.

Thank you, John, and good morning, everyone. and thank you for joining us on today's call. Joining me today are Holly May, President of BioLineRx USA, and Molly Zevi, our Chief Financial Officer. In addition, Ella Serrani, our Chief Development Officer, will be joining the call for Q&A. I will begin with an overview of our stem cell mobilization program, then Holly will provide an update on the effects to launch activities and progress. I will then provide an update on our other clinical programs, notably the metixifortide programs in PDAC and sickle cell disease. Finally, Molly will provide a discussion of our financial results. We will then open up the call and are looking forward to your questions. We have made substantial progress since our last quarterly update with our stem cell mobilization program. We were very pleased to announce in September the US FDA approval of metixifortide known commercially as Effecsta, in combination with GCSF to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma. The approval of Effecsta is the culmination of tireless work by the entire BioLine Rx team and transitions us to a commercial stage company that is bringing to patients physicians, and caregivers their first true advancement in stem cell mobilization in more than a decade. As Holly will detail shortly, we have built out our U.S. commercial infrastructure, which has been engaging in pre- and post-launch activities to support a robust future for Afexta. Feedback from our initial outreach to top-tier transplant centers across the U.S. suggests that Afexta fills a significant unmet need for a more effective mobilization regimen, conferring benefits to centers, payers, and patients alike. This encouraging feedback gives us great optimism, the long-term opportunity that is in front of us. There are many factors driving the need for improved stem cell mobilization regimen, several of which we have covered in our prior calls. The population of multiple myeloma patients undergoing autologous stem cell mobilization has expanded to include older patients over the past decade, with 36% of patients age 65 or over in 2021. Older age has been shown to impair stem cell mobilization as stem cell counts decrease with age. In addition, the introduction of stronger induction therapies has further impaired mobilization, including drugs such as lenalidomide and daratumumab, which are often given in combination. As a result, many patients may require multiple aporesis sessions. Recall that the approval of effects that was based on results from the highly successful Genesis Phase III clinical trial, and in this contemporary trial, most patients received lenalidomide-containing induction regimens, and the median age in the metixifortide treatment arm was approximately 64 years old. particularly relevant to transplant sensors in the Genesis trial, affects the plus GCSF-enabled almost 90% of patients who proceed to transplantation after only one aporesis session. Also, as a reminder, multiple myeloma is the second most common hematologic malignancy, and autologous stem cell transplantation remains the standard of care treatment and has been shown to prolong the lives of patients with this cancer type. And historically, depending on treatment regimens, up to 47% of patients have faced challenges mobilizing the target number of stem cells after one session. With Effecsta as the potential backbone of a new mobilization paradigm, we are optimistic that many more multiple myeloma patients will be candidates for this life-extending procedure and will benefit from what we are calling an A-plus transplantation experience. At this point, I'd like to turn the call over to Holly May, President of BioLineRxUSA, for review of our launch activities. Holly, please go ahead.