BioLineRx(US:BLRX)2022-11-15 20:11Financial Data and Key Metrics Changes - Research and development expenses for Q3 2022 were $4.4 million, an increase of $0.5 million or 11.3% compared to $4.9 million for Q3 2021 [31] - For the nine months ended September 30, 2022, research and development expenses were $14.2 million, a decrease of $0.1 million or 1% compared to $14.3 million for the same period in 2021 [32] - Cash balance as of September 30, 2022, was $57.3 million, which includes $10 million from the Kreos agreement and $13.5 million in net proceeds from a registered direct offering [33] Business Line Data and Key Metrics Changes - The NDA for motixafortide, now known as APHEXDA, was submitted and accepted by the FDA, with a PDUFA target action date set for September 9, 2023 [6][12] - Approximately 90% of patients in the GENESIS study went directly to transplantation after mobilizing the optimal number of stem cells following one administration of APHEXDA [8] - The combination of APHEXDA and GCSF resulted in a median collection of approximately 11 million stem cells per kilogram, compared to approximately 2 million in the GCSF arm [9] Market Data and Key Metrics Changes - The US stem cell mobilization market was approximately $360 million annually in 2021 and is expected to grow steadily, with a global market exceeding $500 million [13] - The stem cell mobilization market is highly concentrated, with approximately 80 transplant centers performing about 80% of procedures [14] Company Strategy and Development Direction - The company plans to commercialize APHEXDA independently to accelerate its availability to multiple myeloma patients and maximize the asset's value [12] - The company is focusing on advancing motixafortide in pancreatic cancer through a collaboration with GenFleet Therapeutics, which will conduct a Phase 2B clinical study in China [19] - The company aims to expand the indications for motixafortide beyond multiple myeloma, exploring opportunities in sickle cell anemia and pancreatic cancer [67] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the rapid market uptake of APHEXDA if approved, due to its benefits to multiple healthcare stakeholders [11] - The company is well-positioned financially to execute a robust launch plan, with a cash balance that supports multiple value-creating milestones into the first half of 2024 [33] - Management anticipates a catalyst-rich 2023, with key milestones including the potential FDA approval of APHEXDA and the initiation of a Phase 2B study in PDAC [35][70] Other Important Information - The company completed two financings, providing access to up to $55 million, including a $40 million non-dilutive debt financing agreement and a $15 million registered direct equity offering [15][17] - The Chief Medical Officer, Abi Vainstein-Haras, will depart the company effective December 31, 2022, but will remain as an advisor through at least the end of 2023 [36] Q&A Session Summary Question: Will the FDA hold an Advisory Committee meeting for the application? - The FDA has stated they are not currently planning to hold an Advisory Committee meeting to discuss the application [38] Question: What are the primary rate limiting steps for the launch of APHEXDA? - Management is not worried about rate limiting steps, citing a manageable launch and strong market research [40][41] Question: What is the current status of the PDAC program and additional tumor indications? - The company is focusing on the collaboration with GenFleet and the ongoing study with Columbia University, with plans to partner out solid tumor indications once data is available [49][50] Question: Will AGI-134 data be announced at a conference or via press release? - A press release with data from the AGI-134 study is planned by the end of the year, with potential conference presentations in the following year [52][58] Question: What is the anticipated size and structure of the salesforce for APHEXDA? - The company is still analyzing the size of the salesforce but plans to have sales professionals in the field ahead of the launch, focusing on top transplant centers [59][60]