Earnings call transcript: BrainStorm Cell Therapeutics Q1 2025 sees stock surge after trial updates
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Overview
The earnings call reveals significant financial constraints, with only $0.4 million in cash and an annual funding need of $20-$30 million. Despite positive regulatory milestones and strategic partnerships, the company's financial health is precarious, and funding is critical to trial commencement. The Q&A highlights concerns about funding and manufacturing capacity, with management providing unclear responses. The negative financial outlook and uncertainties in trial execution and funding overshadow positive developments, suggesting a negative stock price reaction.
Key Financial Performance
Funding $15,000,000 nondilutive grant currently under review, which is essential for commencing the trial.
Clinical Trial Sites Approximately 15 leading clinical centers across the United States are being engaged for the Phase 3b trial.
Patient Enrollment The trial aims to enroll 200 patients within two to three years.
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Operating Highlights
NurOwn Technology: The company is focused on executing the clinical development plan for NurOwn, with the initiation of a pivotal Phase 3b trial to confirm its therapeutic benefit for early-stage ALS patients.
FDA Clearance: The US FDA has cleared BrainStorm to initiate the Phase 3b trial, marking a significant milestone for the company.
Clinical Trial Sites: BrainStorm is negotiating clinical trial agreements with approximately 15 leading clinical centers across the United States for the Phase 3b trial.
Exosome Program: The company is pursuing strategic partnerships to advance its exosome program, which shows potential in treating respiratory and inflammatory diseases.
Manufacturing Capabilities: Initial manufacturing for the Phase 3b trial will take place at the Tel Aviv Sorsky Medical Center, with plans for technology transfer to Pluri for additional clean room facilities.
Funding Efforts: BrainStorm is actively pursuing multiple funding avenues, including a promising $15 million non-dilutive grant and strategic partnerships.
Trial Name: The Phase 3b trial is named 'Endurance' to resonate with the ALS community and reflect the company's commitment to delivering therapeutic options.
U.S. Manufacturing Expansion: The company plans to expand its manufacturing footprint in the U.S. and will announce a letter of intent with a U.S.-based facility that has passed FDA inspection.
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Risk or Challenges
Financial Constraints: The company is facing significant financial constraints, which is a common challenge for small biotech firms. This situation necessitates securing proper funding to initiate and execute clinical trials.
Funding Requirements: The initiation of the Phase 3b trial requires robust and sustainable cash flow. The company is actively pursuing multiple funding avenues, including a promising $15 million non-dilutive grant and strategic partnerships.
Regulatory Risks: While the FDA has cleared the company to initiate the trial, there are inherent risks associated with regulatory approvals and the potential for changes in trial design or endpoints.
Manufacturing Challenges: The company is scaling up manufacturing capabilities and transitioning to a new facility, which poses risks related to production capacity and timelines for the trial.
Clinical Trial Execution: The execution of the clinical trial involves negotiations with multiple clinical sites, which can introduce delays or complications in patient enrollment.
Market Competition: The company operates in a competitive landscape for neurodegenerative treatments, which may impact its market position and the success of its product.
Scientific Uncertainties: The trial's success is contingent on the efficacy of the NurOwn technology platform, which is still under investigation and subject to scientific uncertainties.
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Guidance & Outlook
Clinical Development Plan: The primary focus remains on executing the clinical development plan for NurOwn, including the initiation of a pivotal Phase 3b trial for ALS.
Regulatory Milestone: The US FDA has cleared the company to initiate the Phase 3b trial, marking a significant milestone.
Manufacturing Expansion: Plans to initiate manufacturing for the Phase 3b trial at Tel Aviv Sorsky Medical Center and proceed with technology transfer to Pluri for additional clean room facilities.
Strategic Partnerships: The company is actively pursuing strategic partnerships and funding opportunities to support the trial.
Exosome Program: The exosome program is showing promise, with ongoing preparations for clinical development and strategic partnerships.
Funding Requirements: Securing proper funding is essential to commence the trial, with efforts including a $15 million non-dilutive grant under review.
Trial Enrollment: The trial aims to enroll approximately 200 patients over two to three years, with a focus on timely patient enrollment.
BLA Filing: A Biologics License Application (BLA) will be filed if the trial meets statistical significance in the first part.
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Shareholder Return Plan
Funding Opportunities: The company is actively pursuing multiple funding avenues, including a promising $15,000,000 non-dilutive grant currently under review, alongside ongoing negotiations for strategic partnerships.
Shareholder Return Plan: The company emphasizes the importance of securing proper funding to commence the clinical trial, indicating that financial stability is crucial for future shareholder returns.
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Key Q&A
Q:Can you start the trial without proper funding?
A:While our financials over the past year and a half have reflected a very challenging environment, we have nonetheless been able to make significant strides in preparing for the trial. However, initiating and successfully executing a clinical trial of this nature demands a robust and sustainable cash flow. Therefore, securing proper funding is essential to commence a trial.
Q:What’s the meaning of the trial name 'Endurance'?
A:The name Endurance was carefully chosen to resonate with the ALS community, symbolizing the strength and spirit of individuals living with ALS and their families. It also underscores our commitment to persevere in our scientific endeavors.
Q:Will the company also be producing in The U.S.?
A:Absolutely, expanding our manufacturing footprint for The United States is a key strategic objective for us. We will be announcing a letter of intent with a US-based facility that has successfully passed FDA inspection.
Q:Can you update on any advances in the exosome program?
A:We are highly encouraged by the progress of our exosome program, demonstrating therapeutic effects in models of lung disease. We are preparing a manuscript detailing the efficacy of our exosomes and actively pursuing strategic partnerships for clinical development.
Q:Review of Unclear Management Responses
A:Management appeared to avoid giving a direct answer regarding the specific number of patients that can be enrolled per month based on manufacturing capacity, stating that they are working on final steps of that plan and cannot share exact numbers at this time.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
ALSFRS onca
ANKA story
Agreement FDA
Anatas Neta
Assessment Agreement
Aviv facility
BLA President
BLA lot
BrainStorm Cell
CTA month
CTAs site
Chief Executive
Dagger Executive
Development BrainStorm
EAP study
Executive Officer
FDA biomarker
GANT
Officer BrainStorm
President Chief
Vice President
condition
culture
level
mechanism action
medium
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stratification
BCLI Transcript
Brainstorm Cell Therapeutics Inc. (BCLI) Q2 2025 Earnings Call Transcript
Unknown8-14
The company faces significant regulatory and funding challenges, including a downgrade to OTCQB, delaying the Phase IIIb trial and impacting investor confidence. Operational delays and cash flow concerns further exacerbate the situation. Despite some positive clinical data, the uncertainty and lack of clear FDA guidance contribute to a strong negative sentiment, likely leading to a sharp stock price decline.
Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) Q1 2025 Earnings Call Transcript
Unknown5-20
The earnings call highlights significant financial constraints and uncertainties in funding and regulatory pathways, despite some positive developments like FDA clearance for the trial and promising preclinical data. The Q&A reveals management's lack of clarity on crucial operational details, such as patient enrollment capacity, which adds to the uncertainty. While there are efforts to secure funding and strategic partnerships, the overall sentiment leans negative due to financial challenges and risks associated with trial success and market competition.
Earnings call transcript: BrainStorm Cell Therapeutics Q1 2025 sees stock surge after trial updates
Unknown5-19
The earnings call reveals significant financial constraints, with only $0.4 million in cash and an annual funding need of $20-$30 million. Despite positive regulatory milestones and strategic partnerships, the company's financial health is precarious, and funding is critical to trial commencement. The Q&A highlights concerns about funding and manufacturing capacity, with management providing unclear responses. The negative financial outlook and uncertainties in trial execution and funding overshadow positive developments, suggesting a negative stock price reaction.
Brainstorm Cell Therapeutics Inc. (BCLI) Q1 2025 Earnings Call Transcript
Unknown5-19
The earnings call reveals a mixed financial performance with revenue growth and reduced net loss, but significant cash constraints. The company faces operational risks, competitive pressures, and dependency on successful trial outcomes. The Q&A highlights funding uncertainties and lack of clear guidance on trial logistics. Despite positive developments in partnerships and programs, the absence of a share repurchase plan and reliance on future funding present negative signals. Given these factors, and the lack of market cap data, the stock price is likely to react negatively in the short term.
BCLI Report
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