BioLineRx(BLRX) - 2019 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Research and development expenses for the six months ended June 30, 2019, were $9.7 million, an increase of $0.1 million, or 2%, compared to $9.6 million for the same period in 2018, primarily due to higher expenses associated with clinical trials [23] - The company held $35.2 million in cash, cash equivalents, and short-term bank deposits as of June 30, 2019, compared to $30.2 million as of December 31, 2018 [24] Business Line Data and Key Metrics Changes - The company is advancing its lead therapeutic candidates, BL-8040 and AGI-134, for multiple cancer indications, with BL-8040 being evaluated in Phase 2 and Phase 3 clinical trials for pancreatic cancer, acute myeloid leukemia (AML), and stem cell mobilization [7][8] - In AML, data from a Phase 2a study showed a 39% overall response rate and a median overall survival of 10.7 months, compared to 6.1 months for historical data with cytarabine alone [15] Market Data and Key Metrics Changes - The company is collaborating with Merck on the COMBAT/KEYNOTE-202 study, which is evaluating BL-8040 in combination with KEYTRUDA and chemotherapy for pancreatic cancer [10] - The GENESIS trial for stem cell mobilization is ongoing, with expectations for top-line results in the second half of 2020 [19] Company Strategy and Development Direction - The company views BL-8040 as a broad platform molecule that can be combined with various therapies to treat a wide range of cancers [8] - The upcoming data readouts from clinical trials are seen as significant milestones that could open up additional opportunities for partnerships and further development [11][25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data from the COMBAT/KEYNOTE-202 study, indicating that positive results could be transformational for the company [11] - The company plans to meet with regulators to discuss the optimal development path for AML indications based on ongoing studies [15] Other Important Information - The company completed a public offering in February 2019, raising gross proceeds of $15.4 million, which is expected to fund operations through significant clinical milestones into the first half of 2021 [24] Q&A Session Summary Question: What defines a successful outcome in the COMBAT/KEYNOTE-202 interim readout? - Management indicated that while PFS and OS data are significant, they hope to provide response data and some PFS and OS data on a subset of patients by the end of the year [28] Question: Will there be duration of response data in the top-line release? - Management confirmed that there will be duration of response data for some patients in addition to the response rate [30] Question: What are the expectations for the interim analysis of the BLAST trial? - Management emphasized the importance of the interim analysis for decision-making and indicated that they want robust data before proceeding to Phase 3 [32] Question: Will additional immune-related data be provided from the COMBAT trial? - Management stated that they have already proven the mechanism of action in the first part of the trial and will focus on biomarkers to predict patient responses in the future [35] Question: What other tumor types might be compelling for BL-8040 beyond pancreatic cancer? - Management noted that pancreatic cancer is just the beginning, and they see potential in other difficult-to-treat cancers like colorectal cancer and HCC [37]