Release Date: March 31, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Brainstorm Cell Therapeutics Inc (BCLI, Financial) has secured a special protocol assessment with the FDA, significantly de-risking the regulatory pathway for their NurOwn technology.
- The company is actively negotiating clinical trial agreements with approximately 15 leading clinical centers across the United States, indicating strong interest from renowned ALS clinicians and researchers.
- Brainstorm Cell Therapeutics Inc (BCLI) has partnered with IQVIA, a leading clinical research organization, to ensure efficient execution of their Phase 3b trial.
- The company has contracted with Pluri Inc. for clinical manufacturing, leveraging their expertise in GMP-compliant production, and plans to bring an additional US-based manufacturing center online.
- Brainstorm Cell Therapeutics Inc (BCLI) is exploring multiple funding avenues, including licensing non-core assets and non-dilutive financing opportunities such as grants, to secure necessary funding for the Phase 3b trial.
Negative Points
- The company is facing financial constraints, with cash, cash equivalents, and restricted cash at approximately $0.4 million as of the end of December 2024.
- There are perceived delays in initiating the Phase 3b trial due to the intricate and time-consuming nature of regulatory processes and negotiations with clinical trial sites.
- Brainstorm Cell Therapeutics Inc (BCLI) anticipates needing approximately $20 million to $30 million annually to see the trial to its conclusion, which is challenging given the current market conditions for non-revenue biotech companies.
- The company has implemented salary reductions and periods of unpaid work for its staff to manage financial constraints, indicating significant financial pressure.
- Skepticism remains among analysts and investors regarding the efficacy of NurOwn, despite the company's efforts to address these concerns through trial design and collaboration with key opinion leaders.
Q & A Highlights
Q: Some investors are concerned about the delays in initiating the Phase 3b trial. Can you please provide more clarity on the timeline and the reasons for the perceived delays?
A: Chaim Lebovits, President and CEO: The perceived delays are due to the complex nature of updating and submitting necessary models to the IND, including technical transfer and quality assurance documentation. These are not just administrative tasks but involve rigorous scientific and manufacturing processes. Additionally, finalizing clinical trial agreements with multiple sites takes time. We are focused on finalizing these agreements and anticipate announcing the IND model submissions shortly.
Q: Can you elaborate on the financial situation and how you plan to secure the necessary funding for the trial?
A: Chaim Lebovits, President and CEO: We are pursuing multiple funding avenues, including raising approximately $1.64 million through warrant inducement. We are also exploring licensing non-core assets and securing non-dilutive financing through grants. We anticipate needing $20 million to $30 million annually for the trial. As we achieve key milestones, we expect our market valuation to improve, facilitating additional funding.
Q: Some analysts and investors are skeptical about the efficacy of NurOwn. How do you plan to address these concerns?
A: Bob Dagher, EVP and Chief Development Officer: We have designed the Phase 3b trial to provide definitive evidence of NurOwn's efficacy. The trial is focused on the right patient population and has been de-risked through design changes and agreements with the FDA. We are committed to providing robust data to validate NurOwn's efficacy.
Q: What is the status of the manufacturing facilities and how will you ensure a consistent supply of NurOwn?
A: Haro Hartounian, EVP & Chief Operating Officer: We have contracted with Pluri Inc. for clinical manufacturing and are planning to bring an additional US-based manufacturing center online. This multi-faceted approach will ensure a consistent and reliable supply of NurOwn for the trial and beyond.
Q: Given the current financial constraints, how is the company ensuring operational continuity and maintaining its commitment to starting the Phase 3b trial?
A: Chaim Lebovits, President and CEO: Despite financial challenges, our team remains dedicated. We have implemented cost-saving measures, including salary reductions, to prioritize the trial's progress. Our staff is committed to advancing the trial, and we are confident in navigating these challenges.
Q: Why don't you just refile the original BLA?
A: Chaim Lebovits, President and CEO: Refiling the BLA now would not be strategic. We are focused on generating robust data through the Phase 3b trial to address specific concerns and support a new BLA. This approach will lead to a more definitive path to approval.
Q: Can you speak broadly about your thoughts on the changing environment in the cell therapy space, particularly unmodified cells like NurOwn?
A: Chaim Lebovits, President and CEO: The environment is becoming more favorable for cell therapies like NurOwn. We have a strong Special Protocol Assessment with the FDA, and recent approvals in the space are encouraging. We are focused on providing scientific results to support our therapy.
Q: What percentage of financing do you want to have in place before you're comfortable with getting the trial started?
A: Chaim Lebovits, President and CEO: We are working closely with our partners, who are providing significant support. We have additional funding in the pipeline and are confident that once announced, it will provide comfort regarding our plan moving forward.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
