Brainstorm Cell Therapeutics(BCLI) - 2020 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported a net loss of $7.4 million or $0.25 per share for Q2 2020, compared to a net loss of $4.9 million or $0.23 per share for Q2 2019, indicating an increase in losses year-over-year [22][23] - Cash and cash equivalents were approximately $16.2 million as of June 30, 2020, up from approximately $2.7 million as of June 30, 2019, reflecting a significant improvement in liquidity [22][23] - As of July 31, 2020, total available funding was approximately $37.5 million, including cash on hand of approximately $34.7 million and remaining non-dilutive funding from various grants [23] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2020 were $5.69 million, up from $3.55 million in Q2 2019, primarily due to increased materials, payroll, and stock-based compensation costs [21] - General and administrative expenses increased to $1.71 million in Q2 2020 from $1.3 million in Q2 2019, driven by higher payroll and stock-based compensation [22] Market Data and Key Metrics Changes - The company is actively exploring opportunities to expedite the review process with the FDA for its ALS treatment, indicating a proactive approach to market entry [14][27] - The ALS Association and IMALS awarded the company a combined grant of $500,000 to fund an ALS biomarker study, which will enhance understanding of treatment responses [14] Company Strategy and Development Direction - The company aims to expedite the submission of a Biologic License Application (BLA) with the FDA following the top-line data readout expected by the end of November 2020 [14][26] - The company is focusing on expanding its clinical pipeline to include treatments for Alzheimer’s disease and progressive MS, with plans to initiate trials in Europe [15][16][38] - The company is also developing an innovative exosome-based platform technology for treating severe COVID-19, indicating diversification in its research focus [18][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company’s strong financial position, with no debt and a record cash balance, which positions the company well for future growth [7][23] - The management team emphasized the importance of their mission to develop treatments for neurodegenerative diseases, especially during the COVID-19 pandemic [8][9] - The company is committed to addressing the urgent needs of the ALS community and is in close contact with the FDA to expedite the review process [27] Other Important Information - The company has made key additions to its senior management team, enhancing its operational capabilities [9][10] - The Phase III pivotal trial for ALS has enrolled approximately 200 participants, and all scheduled doses have been administered [12][13] Q&A Session Summary Question: Timeline for ALS Phase III data readouts and BLA submission - Management confirmed that the Phase III trial readout is expected in Q4 2020, with top-line data anticipated by the end of November [26][27] Question: Manufacturing plans if FDA approves neuron - The company is actively working with potential partners for commercial manufacturing and has streamlined its manufacturing process [28][29] Question: Update on Phase II progressive MS trial - The Phase II progressive MS trial is fully enrolled with 20 patients, and the company plans to focus on full data analysis rather than interim analysis [32][34] Question: Plans for sales force in the U.S. or Europe - The company is considering both internal and external options for a sales force and is prepared to provide treatments upon approval [65][66] Question: Guidance on earnings - Management highlighted the strong financial position with approximately $35 million cash on hand, indicating confidence in navigating the upcoming quarters [70]