BioLineRx(US:BLRX)2022-03-16 18:52Financial Data and Key Metrics Changes - Research and development expenses for the year ended December 31, 2021, were $19.5 million, an increase of $1.3 million or 7.1% compared to $18.2 million for the year ended December 31, 2020 [29] - The company held $57.1 million of cash, cash equivalents, and short-term bank deposits as of December 31, 2021, indicating a strong financial position to achieve multiple value-creating milestones [30] Business Line Data and Key Metrics Changes - The GENESIS Phase III trial of Motixafortide demonstrated that approximately 90% of patients went directly to transplantation after mobilizing the optimal number of stem cells following only one administration of Motixafortide and in only one apheresis session [8] - The pharmacoeconomic studies showed that Motixafortide plus G-CSF was associated with a statistically significant decrease in healthcare resource utilization during the autologous stem cell transplantation process compared to G-CSF alone [11] Market Data and Key Metrics Changes - The U.S. stem cell mobilization market is estimated to be approximately $360 million in 2021, with over 20,000 hematopoietic stem cell transplantations annually, of which approximately 60% are autologous [19][18] - Multiple myeloma represents the largest opportunity within the U.S. stem cell mobilization market, accounting for approximately 58% of all autologous transplants [18] Company Strategy and Development Direction - The company aims to submit an NDA for Motixafortide as a novel mobilization agent for multiple myeloma patients undergoing autologous stem cell transplantation in mid-2022 [31] - There is a focus on maintaining optionality regarding the launch of Motixafortide, either with a partner or independently, to maximize value extraction from the asset [21] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Motixafortide to become the new standard of care for stem cell mobilization in multiple myeloma patients, driven by its differentiated clinical efficacy and safety profile [9] - The company is planning for an aggressive launch of Motixafortide in 2023, which would represent a significant advancement in stem cell mobilization since the approval of plerixafor in 2008 [22] Other Important Information - The company is also advancing its Motixafortide pancreatic cancer program and the intra-tumoral anticancer vaccine AGI-134, with ongoing discussions for potential partnerships [23][25] - An immuno-oncology Scientific Advisory Board has been formed to guide the development of the immuno-oncology pipeline [26] Q&A Session Summary Question: What might be the current rate limiting step for the NDA? - Management indicated that there are no rate limiting issues for the NDA submission, as all necessary data is being prepared [35][36] Question: What elements are being weighed in the decision to commercialize with a partner or build out internally? - The company is evaluating what will bring the most value to shareholders, considering both partnership and internal commercialization options [41] Question: What kind of sales force is needed to address the transplant centers? - Management suggested that a sales force of around 15 to 20 sales representatives would be sufficient to target the top transplant centers [42]