Brainstorm Cell Therapeutics(BCLI) - 2021 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Research and development expenses for Q2 2021 were $3.59 million, down from $5.69 million in Q2 2020, a decrease of approximately $2.1 million year-over-year [18] - General and administrative expenses increased to $2.52 million in Q2 2021 from $1.71 million in Q2 2020, an increase of approximately $816,000 [19] - Net loss for Q2 2021 was $6.27 million or $0.17 per share, compared to a net loss of $7.39 million or $0.25 per share in Q2 2020 [19] - Cash and cash equivalents were approximately $35 million as of June 30, 2021, down from approximately $40 million on March 31, 2021 [19] Business Line Data and Key Metrics Changes - The company is advancing its NurOwn treatment for ALS and progressive MS, with significant developments in both areas [12][16] - The phase 2 study for progressive MS showed safety and consistent changes across all functional measures, with several participants meeting criteria for clinical improvement [15] Market Data and Key Metrics Changes - The company received GMP approval from the Israeli Ministry of Health for its manufacturing facility, which more than doubles its capacity to supply NurOwn to ALS patients in Israel and Europe [16] Company Strategy and Development Direction - The company aims to secure approval for NurOwn in ALS and is exploring opportunities for its use in other neurodegenerative diseases [38] - The company is focused on gathering data from its expanded access program to support its regulatory strategy [24] Management's Comments on Operating Environment and Future Outlook - Management emphasized the urgency to provide effective treatments for ALS patients and the need for collaboration with government and advocacy groups [8][10] - The company is closely monitoring regulatory developments and is prepared to adapt its strategy accordingly [28] Other Important Information - The company has received strong support from ALS and MS advocacy organizations for its clinical programs [15][31] - A series of patents have been granted or allowed in various territories, strengthening the company's intellectual property position [17] Q&A Session Summary Question: What was the consensus regarding BLA submission based on discussions with ALS experts? - Management remains confident in the effectiveness and safety of NurOwn and is prioritizing the publication of phase 2 data in a peer-reviewed journal [23] Question: Will there be a clinical trial in Europe before NurOwn is accessible to patients? - The company is evaluating regulatory strategies for access outside the U.S. and will provide details once finalized [26] Question: When is the expected BLA submission and timeframe for peer review? - The timeline for the review process is not in the company's control, but they are working to expedite publication [28] Question: Is the hospital exemption program still active in Israel? - The hospital exemption program is not ongoing, but discussions with the Israeli Ministry regarding different regulatory paths are in progress [49] Question: What is the company's cash position and debt status? - The company has approximately $35 million in cash and no debt on its balance sheet [36] Question: Are there plans for future clinical trials? - The company is focused on gaining approval for NurOwn for ALS and exploring indications with a high probability of success [38] Question: Is the company evaluating partnering opportunities? - The company is receiving interest from partners and is in discussions regarding various parts of its pipeline [40]