BioLineRx Ltd. (NASDAQ:BLRX) Q4 2022 Earnings Call Transcript

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BioLineRx Ltd. (NASDAQ:BLRX) Q4 2022 Earnings Call Transcript March 22, 2023

Operator: Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx 2022 Financial Results Conference Call. I would now like to turn over the call to John Lacey, Head of Investor Relations and Corporate Communications BioLineRx. Please go ahead.

John Lacey: 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 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 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 Phil Serlin, Chief Executive Officer of BioLineRx.

Philip Serlin: 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 6-K. 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 Tami Rachmilewitz, 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 Motixafortide, now known by its trade name APHEXDA, 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 APHEXDA 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 APHEXDA arm collected an optimal number of cells for transplantation following a single administration of APHEXDA plus GCSF and in only one apheresis session. These results were superior to GCSF alone. In addition to potentially improving transmit experiences for patients, we believe the use of Motixafortide 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 Motixafortide 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 Motixafortide as a primary stem cell mobilization agent in combination with GCSF against plerixafor in combination with GCSF in multiple myeloma patients undergoing autologous stem cell transplantation. The analysis demonstrated significant net cost savings using Motixafortide plus GCSF with a greater proportion of patients achieving successful mobilization of optimal amounts of stem cells in a single apheresis date. 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 APHEXDA 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 the patients through a very focused outreach to these centers, both 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 APHEXDA stem cell mobilization to date. We are very hopeful that it will ultimately be approved. In anticipation of that, we have been extremely busy moving ahead with critical prelaunch activities. In particular, while the agency has been reviewing our NDA and in advance of our September 9 PDUFA date, we have 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 May, 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 of APHEXDA in stem cell mobilization but also for our life cycle management activities which I will discuss in a moment. More recently, we were also very pleased to hire hematology and transmit commercial veteran, Kevin Campbell 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 Transplant at Sanofi where he led a 23-person commercial team, whose portfolio included plerixafor for stem cell mobilization.

Surgery, Medicine, Health
Surgery, Medicine, Health

Photo by Sander Sammy on Unsplash

Before that, he served as U.S. Marketing Director for plerixafor at Genzyme until the acquisition of that company by Sanofi in 2011. Given the steady growth and expanding use of plerixafor, we believe Kevin is the ideal person to help make APHEXDA 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. Tami Rachmilewitz as our new Chief Medical Officer. Tami 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 reviewed process, expand Motixafortide'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 Motixafortide, metastatic pancreatic cancer or PDAC. Recall that Motixafortide is being evaluated in an investigator-initiated metastatic PDAC trial in collaboration with Columbia University.

That Phase II study is evaluating Motixafortide in combination with the anti-PD-1 LIBTAYO 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 IIb clinical study assessing Motixafortide in combination with a PD-1 inhibitor and standard-of-care chemotherapy and approximately 200 first-line metastatic PDAC patients in China. The collaboration follows the positive results to be reported from our Phase IIa COMBAT/KEYNOTE-202 triple combination study of Motixafortide 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 IIb trial will initiate by the end of this year. In addition to our 2 core clinical programs just mentioned, we are also working to evaluate Motixafortide clinical utility in 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 6 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 regimen 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 Motixafortide for stem cell mobilization in sickle cell disease. The trial which is expected to launch in 2023, will evaluate Motixafortide both as monotherapy and in combination with natalizumab. This represents a very logical expansion of our development pipeline. Of further note, last month, we attended the 2023 Tandem Meeting in Orlando, Florida. Tandem is the combined annual Congress sponsored by the American Society for Transplantation and Cellular Therapy and the Center for International Blood and Marrow Transplant Research.

It is the form of Congress in this space, bringing together leading experts to present the latest cutting-edge science in hematopoietic cell transplantation and cellular therapies. Meetings such as Tandem and other widely attended congresses on cell transplantation and cellular therapies are an important and effective way for BioLineRx to raise its profile among all related constituencies, we plan to attend and present where appropriate at all such meetings going forward. Turning now to our second clinical candidate, the investigational intratumoral anti-cancer vaccine, AGI-134. We believe AGI-134 coats tumor cells with alpha-Gal to make them look like foreign tissue to evoke an immune response that both destroys existing tumors and provides a vaccine-like effect.

We recently announced results from a Phase I/II study in AGI-134 in metastatic solid tumors. The first in-human single-agent study met its primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers. At this time, we are evaluating potential development program pathways in consultation with the program's scientific advisory board. I would now like to turn the call over to Mali Zeevi, our CFO, who will give a brief overview of our main financial results. Mali, please go ahead.

Mali Zeevi: Thank you, Phil. As is our practice in our financial discussion, we will only go over a few significant items on this call: research and development expenses and cash. Therefore, let me invite you to review the filings we made this morning which contain our financials, 20-F and press release for additional information. Research and development expenses for the full year ended December 31, 2022, were $17.6 million, a decrease of $1.9 million or 9.7% compared to $19.5 million for the full year 2021. The decrease resulted primarily from lower expenses related to NDA supporting activities related to Motixafortide as well as lower expenses associated with the completed Motixafortide GENESIS clinical trial, offset by an interest in expenses associated with the AGI-134 study and increase in payroll and related expenses.

Turning to cash. The company held $51.1 million in cash, cash equivalents and short-term bank deposits as of December 31, 2022. This does not include $30 million available to us under our debt agreement with Kreos Capital which is tied to the payment of certain milestones. We believe we are well financed to fund our operations as currently planned into the first half of 2024. And with that, I'll turn the call back over to Phil.

Philip Serlin: Thank you, Mali. In closing, as is our custom, I would like to take a few moments to summarize our key upcoming milestones. Potential FDA approval of APHEXDA in September 2023. The potential U.S. launch of APHEXDA stem cell mobilization shortly after approval. Initiation of a clinical trial in collaboration with Washington University School of Medicine to evaluate Motixafortide as monotherapy and in combination with natalizumab for CD34-positive hematopoietic stem cell mobilization for gene therapies in sickle cell disease in 2023. Initiation of Phase IIb randomized clinical trial with 200 patients, assessing Motixafortide in combination with the PD-1 inhibitor and standard-of-care chemotherapy as a first-line metastatic PDAC therapy with collaboration partner GenFleet in 2023.

An initial cohort data from the ongoing Columbia University investigated initiated trial evaluating Motixafortide in combination with the PD-1 inhibitor LIBTAYO and standard-of-care chemotherapy in first-line metastatic PDAC patients also in 2023. With that, we have now concluded the formal part of our presentation. Operator, we will now open up the call to questions.

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