Brainstorm Cell Therapeutics(US:BCLI)2019-11-14 18:51Financial Data and Key Metrics Changes - Research and development expenses for Q3 2019 were $4.01 million, up from $1.97 million in Q3 2018, with a year-over-year increase of $1.59 million when excluding certain grants [17] - General and administrative expenses increased to $1.54 million in Q3 2019 from $1.26 million in Q3 2018, primarily due to higher payroll and stock-based compensation [17] - Net loss for Q3 2019 was $5.6 million or negative $0.25 per share, compared to a net loss of $3.17 million or negative $0.15 per share in Q3 2018 [18] Business Line Data and Key Metrics Changes - The Phase 3 ALS clinical trial was fully enrolled with 200 patients, and results are expected to be published in Q4 2020 [9] - The Phase 2 progressive MS trial is progressing well, with eight patients enrolled and expected readout in Q4 2020 [11] Market Data and Key Metrics Changes - The company received an additional $1.6 million from the Hospital Exemption pathway in Israel, aiding in the treatment of ALS patients [12] - The total available funding, including cash and remaining grants, amounts to approximately $5.9 million [18] Company Strategy and Development Direction - The management is engaged in strategic partnerships and collaborations, emphasizing that any agreements will prioritize patient and shareholder interests [14] - The company is focused on expanding its Investor Relations program and increasing awareness among institutional investors [27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding ongoing engagement with the FDA and the ALS community, highlighting productive meetings and the potential for future collaborations [12][21] - The company is preparing for potential commercialization and has plans to ramp up manufacturing capabilities in anticipation of BLA approval [76] Other Important Information - The management team is actively exploring additional grants and funding opportunities to support ongoing clinical trials and operations [19][73] - The company is working on improving its manufacturing process to reduce costs and increase efficiency [59][77] Q&A Session Summary Question: Did BrainStorm management meet with FDA officials? - Yes, there was a productive meeting with FDA officials in September, and ongoing meetings are scheduled [21][22] Question: How does management plan to increase shareholder value? - The focus is on reaching out to institutional investors and exploring strategic partnerships while being selective in capital raising [27] Question: What is the status of the Hospital Exemption program in Israel? - The program is proceeding well, with ten patients enrolled and potential for additional approvals [29] Question: What updates are there on the Phase 2 MS trials? - Eight patients have been enrolled, and the trial is expected to complete enrollment by late spring [33] Question: Has the company submitted any data for expedited approvals? - Yes, data from the Phase 2 trial has been submitted, and fast track designation has been granted [35] Question: What is the competitive landscape for ALS treatments? - The competitive landscape is limited in later-stage programs, with BrainStorm positioned to be among the first to report results [43]