BioLineRx(US:BLRX)2021-11-18 19:25Financial Data and Key Metrics Changes - Research and development expenses for the nine months ended September 30, 2021, were $14.3 million, an increase of $0.8 million or 5.9% compared to $13.5 million for the comparable period in 2020 [34] - The company held $62.2 million in cash, cash equivalents, and short-term bank deposits as of September 30, 2021, indicating strong financial positioning to achieve multiple value-creating milestones [35] Business Line Data and Key Metrics Changes - The GENESIS Phase 3 study reported that 89% of patients receiving Motixafortide in combination with G-CSF mobilized the optimal number of cells after only one administration and one apheresis session, compared to 10% for G-CSF alone [10][12] - The median number of cells collected in one apheresis session was 11 million for the Motixafortide G-CSF arm, significantly higher than the 2 million cells collected with G-CSF alone [11][22] Market Data and Key Metrics Changes - The global estimated market for autologous stem cell transplantation is approximately $500 million, with over 45,000 procedures performed annually in the U.S. and Europe [24] - The first-generation CXCR4 inhibitor, plerixafor, generates annual sales exceeding $250 million, primarily used as a rescue therapy [24] Company Strategy and Development Direction - The company plans to submit a New Drug Application (NDA) to the FDA in the first half of 2022, following a pre-NDA meeting scheduled for mid-December [25][37] - Future plans include evaluating lifecycle management potential in other autologous stem cell mobilization indications and exploring partnerships for commercialization rather than self-commercialization [52] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the positive results from the GENESIS study and the pharmacoeconomic study, viewing them as significant milestones for the company [38][56] - The company anticipates a catalyst-rich 2022, with meaningful clinical benefits for patients and considerable value creation for shareholders [56][57] Other Important Information - The pharmacoeconomic study indicated a net cost savings of approximately $17,000 per patient when using Motixafortide in combination with G-CSF compared to the current standard-of-care [20][21] - The company has a notable presence at the upcoming American Society of Hematology Annual Meeting, with four abstracts accepted for presentation [29][30] Q&A Session Summary Question: Key components for the upcoming pre-NDA meeting with the FDA - Management aims to align with the FDA on the overall content of the NDA submission [40][41] Question: Next steps for AGI-134 and potential randomized studies - Future steps will depend on the data from the current study, with considerations for patient populations and combination therapies [42][44] Question: Update on the timing of the first data for the academic sponsored trial - Recruitment is ongoing for the investigator-initiated trial, but specific timelines cannot be provided [46][47] Question: Delay in AGI-134 data and presentation at conferences - Recruitment delays were primarily due to COVID-19, but completion is expected by the end of the year, with data anticipated in the first half of next year [48][49] Question: Commercialization strategy for Motixafortide - The company is exploring collaboration options for commercialization rather than self-commercialization due to operational and financial risks [52] Question: Applicability of pharmacoeconomic study results in Europe - The cost structure in Europe differs from the U.S., and while the model can be adapted, the company believes similar significant benefits could be observed [54]