BioLineRx(US:BLRX)2023-08-30 16:58Financial Data and Key Metrics Changes - Research and development expenses for Q2 2023 were $3 million, a decrease of $2.4 million or 44.3% compared to $5.4 million in Q2 2022, primarily due to lower NDA supporting activities for Motixafortide and completed AGI-134 clinical trial expenses [25] - Net loss for Q2 2023 was $18.5 million, compared to $7.4 million in Q2 2022, with a six-month net loss of $30.7 million compared to $12.4 million in the same period last year [26] - The company held $32.8 million in cash, cash equivalents, and short-term bank deposits as of June 30, 2023, excluding approximately $30 million from a strategic partnership and $30 million available under a debt agreement [27] Business Line Data and Key Metrics Changes - The lead program, Motixafortide, is preparing for a PDUFA target action date of September 9, 2023, which could transition the company to a commercial stage [7] - The U.S. market potential for mobilization agents in stem cell transplants is estimated at around $300 million, with about 50% from autologous stem cell transplants in multiple myeloma [10] - A new strategic partnership in Asia includes a $15 million upfront payment and potential milestone payments totaling approximately $250 million [11][12] Market Data and Key Metrics Changes - The company is focusing on the U.S. market for the launch of Motixafortide, with strong relationships being built with payers and healthcare providers [9][38] - In Asia, the partnership will require some countries to conduct bridging studies for approval, while others may rely on FDA approval [41][42] Company Strategy and Development Direction - The company aims to capture a significant share of the multiple myeloma transplant market and is well-positioned for the commercial launch of Motixafortide [10] - There are plans for a randomized Phase 2/3 clinical trial in China for Motixafortide in combination with a PD-1 inhibitor for metastatic pancreatic cancer [15] - The company is exploring additional therapeutic areas for Metixafortide, including gene therapy for sickle cell disease [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming FDA approval and the readiness for a quick market entry if approved [38] - The company is optimistic about the potential of Motixafortide to address unmet needs in multiple myeloma and pancreatic cancer [19] - The strategic partnership is expected to strengthen the company's balance sheet and provide sufficient capital for operations beyond the launch [53] Other Important Information - The company announced a collaboration with Washington University School of Medicine to evaluate Metixafortide for gene therapies in sickle cell disease [20] - The company is preparing for significant advancements in its pancreatic development program and further positioning Motixafortide for development in Asia [59] Q&A Session Summary Question: Can you share details about the launch logistics for the upcoming PDUFA date? - Management confirmed readiness for a quick market entry if approved, with supply and distribution agreements already in place [38] Question: What are the timelines for tech transfer in the Asian partnership? - Management indicated that some countries may rely on FDA approval, while others, like China and Japan, may require bridging studies [41][42] Question: How does the Asian partnership impact the company's financial strategy? - The partnership significantly strengthens the balance sheet, providing over $60 million in cash, which is expected to support operations well into 2024 [53] Question: What is the expected cash burn rate going forward? - The current burn rate is estimated between $7.5 million to $10 million per quarter, expected to stabilize around $7 million to $8 million post-launch [54]