BioLineRx(BLRX) - 2019 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Research and Development expenses for the nine months ended September 30, 2019, were $15.3 million, an increase of $0.7 million, or 5%, compared to $14.6 million for the same period in 2018 [33] - The company held $30.1 million of cash, cash equivalents, and short-term bank deposits as of September 30, 2019, sufficient to fund operations through significant clinical milestones [34] Business Line Data and Key Metrics Changes - The company is progressing its lead therapeutic candidates BL-8040 and AGI-134 for multiple cancer indications, with BL-8040 being evaluated in several phase 2 and phase 3 clinical trials [7] - BL-8040 has been granted FDA orphan drug designation for pancreatic cancer, acute myeloid leukemia (AML), and stem cell mobilization [9] - The GENESIS trial for stem cell mobilization is ongoing, with top-line results expected in the second half of 2020 [26] Market Data and Key Metrics Changes - The prognosis for pancreatic cancer patients remains poor, with low survival rates, highlighting the urgent need for better therapeutic options [12] - The company is collaborating with Genentech to evaluate BL-8040 in dual combinations for pancreatic and gastric cancers, with results expected in the first half of 2020 [21] Company Strategy and Development Direction - The company aims to partner out BL-8040 for all indications, with a focus on licensing opportunities following upcoming data releases [41] - The strategy includes leveraging data from ongoing trials to attract potential partners, particularly in the larger AML and pancreatic cancer markets [42] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data readouts, particularly from the COMBAT/KEYNOTE-202 study, which could be transformational for treatment options in pancreatic cancer [11] - The company plans to provide updates on interim results from the AML study and top-line results from the GENESIS trial in 2020 [38] Other Important Information - The company has been invited to present at the European Society of Medical Oncology, highlighting the significance of the upcoming data [19] - AGI-134 is currently in a Phase 1/2a study, with initial efficacy results expected by the end of 2020 [31] Q&A Session Summary Question: Broader potential commercial profile for BL-8040 - Management is looking to partner out BL-8040 for all indications, with a focus on licensing opportunities following data releases in pancreatic cancer, AML, and stem cell mobilization [41] Question: Differences in patient populations for trials - The patient population in the triple combination study is more homogeneous, which is expected to yield more powerful data compared to earlier studies [48] Question: Inclusion of graphical data in presentations - Management confirmed that graphical representations, including spider plots, will be included in the upcoming presentation to illustrate treatment effects [50]