Financial Data and Key Metrics Changes - The company reported significant progress in preparing for the Phase 3b trial of NurOwn, with a focus on securing funding to support trial initiation [24][25] - Financial constraints have been acknowledged, but the company has made strides in regulatory submissions and site selections despite limited resources [13][24] Business Line Data and Key Metrics Changes - The primary focus remains on the clinical development of NurOwn, with the initiation of a pivotal Phase 3b trial aimed at ALS patients [6][10] - The trial design has been agreed upon with the FDA, which is expected to de-risk the regulatory pathway for NurOwn [6][7] Market Data and Key Metrics Changes - The company is actively negotiating with approximately 15 leading clinical centers across the United States for the Phase 3b trial [10] - The trial, named "Endurance," aims to resonate with the ALS community and reflects the company's commitment to developing a therapeutic option for ALS [26] Company Strategy and Development Direction - The company is focused on executing the clinical development plan for NurOwn and is preparing for a significant trial that could lead to regulatory approval [6][12] - There is an emphasis on expanding manufacturing capabilities in the U.S. to support future commercialization and supply chain security [28] Management's Comments on Operating Environment and Future Outlook - Management highlighted the urgency felt by patients and clinicians for innovative therapeutic options in ALS, reinforcing their commitment to executing the trial with scientific rigor [11][12] - The company is pursuing multiple funding avenues, including a promising $15 million non-dilutive grant, to ensure timely trial commencement [25][14] Other Important Information - The company participated in the annual ALF Drug Development Summit, discussing critical areas in ALS therapeutic development [12] - The scientific team is engaged with the academic community to share insights and data, which is crucial for advancing the NurOwn program [12] Q&A Session Summary Question: Can you start the trial without proper funding? - Management emphasized that while significant progress has been made, securing proper funding is essential to commence the trial [24][25] Question: What is the meaning of the trial name "Endurance"? - The name reflects the strength and resilience of the ALS community and the company's commitment to delivering a therapeutic option [26] Question: Will the company also be producing in the U.S.? - The company confirmed plans to expand manufacturing in the U.S. and will announce a letter of intent with a U.S.-based facility soon [28] Question: Can you update on any advances in the exosome program? - The company is encouraged by the progress of its exosome program and is preparing a manuscript detailing its efficacy in preclinical models [32]

Financial Data and Key Metrics Changes - The company is focused on executing the clinical development plan for NurOwn and has received FDA clearance to initiate a pivotal Phase 3b trial for ALS [6][10] - Financial constraints have been acknowledged, but the company has made significant strides in trial preparations despite limited resources [13][25] Business Line Data and Key Metrics Changes - The NurOwn technology platform is central to the company's strategy, with ongoing clinical trials aimed at demonstrating its therapeutic benefits [6][12] - The company is actively negotiating clinical trial agreements with approximately 15 leading clinical centers across the U.S. for the Phase 3b trial [10][25] Market Data and Key Metrics Changes - The ALS community's strong interest in NurOwn is highlighted by the engagement of renowned ALS clinicians and researchers [10] - The company participated in the annual ALF Drug Development Summit, indicating its active involvement in the ALS therapeutic development landscape [12] Company Strategy and Development Direction - The company aims to secure strategic funding to support the trial, with a focus on partnerships and non-dilutive grants [14][26] - Expansion of manufacturing capabilities in the U.S. is a key strategic objective, with plans to announce a letter of intent with a U.S.-based facility [30] Management's Comments on Operating Environment and Future Outlook - Management emphasized the urgency for innovative therapeutic options in ALS and the commitment to executing the trial with scientific rigor [11][12] - The company is optimistic about the potential of NurOwn and is preparing for various funding opportunities to ensure timely trial commencement [14][26] Other Important Information - The trial, named "Endurance," is designed to resonate with the ALS community, reflecting the strength and resilience of ALS patients [27] - The company is encouraged by progress in its exosome program, which shows potential in treating respiratory and inflammatory diseases [34] Q&A Session Summary Question: Can you start the trial without proper funding? - Management stated that while significant progress has been made, proper funding is essential to commence the trial [25][26] Question: What is the meaning of the trial name "Endurance"? - The name was chosen to resonate with the ALS community and reflects the company's commitment to delivering a therapeutic option for ALS [27] Question: Will the company also be producing in the U.S.? - The company confirmed plans to expand its manufacturing footprint in the U.S. and will announce a letter of intent with a U.S.-based facility [30] Question: Can you update on any advances in the exosome program? - Management expressed encouragement regarding the exosome program's progress and is preparing to advance it towards clinical development [34] Question: Have you had any communications with FDA regarding stratification by UNC13A? - Management indicated that while the FDA has not approved any biomarker as a surrogate, they are excited about the genetic discoveries and will explore them further [39][40] Question: Can the mechanism of action be used as part of the data package for the next BLA? - Management confirmed that the protective effect observed in cell cultures could support the data package for future filings [43] Question: How many clinical trial sites are you looking to open? - Management confirmed plans to open approximately 15 clinical trial sites and is finalizing agreements to begin patient enrollment [48][50]