BioLineRx(US:BLRX)2019-03-28 17:27Financial Data and Key Metrics Changes - Research and development expenses in 2018 were $19.8 million, an increase of $0.3 million or 1.5% compared to $19.5 million for 2017, primarily due to an increase in share-based compensation [33] - The company held $30.2 million in cash, cash equivalents, and short-term bank deposits as of December 31, 2018, and completed a public offering in February 2019 with gross proceeds of $15.4 million, providing a runway of almost two and a half years to fund operations through significant clinical milestones [34] Business Line Data and Key Metrics Changes - The company is advancing therapeutic candidates BL-8040 and AGI134 for multiple cancer indications, with BL-8040 being evaluated in eight Phase 2 or Phase 3 clinical trials [7][8] - BL-8040 has demonstrated robust mobilization of target cells and the ability to induce infiltration of T-cells into tumors while maintaining a favorable safety profile [10] - The company revised its license agreement with Biokine Therapeutics to increase its economic stake in BL-8040 to 80% from 60% [11] Market Data and Key Metrics Changes - The ongoing collaboration with Merck and Genentech validates the platform and provides confidence in BL-8040's mechanism of action [9] - The disease control rate for pancreatic cancer patients in a trial was 34.5%, with an overall survival of 3.3 months for all patients and 7.5 months for second-line patients [17] Company Strategy and Development Direction - The company aims to position BL-8040 as a potential game changer in stem cell mobilization, adding clinical and pharmacoeconomic value [14] - The focus is on advancing BL-8040 in multiple myeloma and pancreatic cancer, with plans to meet with regulatory authorities to discuss clinical development pathways [22] - The company is also developing AGI-134 for solid tumors, with a Phase 1/2a study initiated to assess safety and tolerability [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for additional partnerships to complement current programs [30] - The company is collecting pharmacoeconomic data in parallel with clinical studies to support future reimbursement discussions [52] Other Important Information - The company was granted FDA orphan drug designation for BL-8040 for the treatment of pancreatic cancer, adding significant value to the program [19] - The company expects interim results from the Phase 2 AML consolidation study and initial safety results from the AGI-134 trial in the second half of 2019 [36] Q&A Session Summary Question: Can you review the multiple myeloma treatment paradigm and where BL-8040 fits? - Management clarified that bone marrow transplantation remains the standard of care and that BL-8040 aims to reduce patient burden without competing with new therapies [39][40] Question: What are the market dynamics regarding HSCTs in multiple myeloma? - Management indicated that approximately 70% to 75% of transplants are performed at around 50 major centers in the U.S. [43] Question: Can you elaborate on AGI-134's mechanism of action and its synergy with checkpoint inhibitors? - Management explained that AGI-134 has shown synergistic effects in preclinical models when combined with checkpoint inhibitors [46][47] Question: What pharmacoeconomic work is being done for the stem cell program? - Management confirmed that extensive work has been done to map cost elements for the Phase 3 study, which will aid in economic justification for payers [51][52] Question: What can you tell us about the pending interim readout from the BLAST study? - Management stated that the timing for the interim analysis is being carefully considered to ensure robust data is available for reporting [55][56] Question: Are there plans for label expansions beyond multiple myeloma? - Management indicated interest in expanding the label into non-Hodgkin lymphoma and other indications but emphasized the current focus on multiple myeloma [62]