Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) Q1 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
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.
Key Financial Performance
Funding $15 million non-dilutive grant currently under review.
Financial Constraints Significant financial constraints faced over the past year and a half.
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Operating Highlights
NurOwn Technology: The company is focused on the execution of the clinical development plan for NurOwn, with the initiation of a pivotal Phase 3b trial to confirm its therapeutic benefit for individuals in the early stages of ALS.
Exosome Program: The exosome program is showing strong potential in treating respiratory and inflammatory diseases, with promising preclinical data and plans for clinical development.
Market Expansion: The company is expanding its manufacturing footprint in the U.S. and has signed a letter of intent with a U.S.-based facility that has passed FDA inspection.
Operational Readiness: The company is actively engaged in negotiations for clinical trial agreements with approximately 15 leading clinical centers across the U.S. for the Phase 3b trial.
Funding Efforts: Brainstorm is pursuing multiple funding avenues, including a promising $15 million non-dilutive grant and strategic partnerships to secure necessary capital for the trial.
Strategic Partnerships: The company is focusing on securing strategic partnerships to ensure timely commencement of the trial and to advance the exosome program.
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Risk or Challenges
Regulatory Risks: The company faces uncertainties related to the regulatory pathway for NurOwn, although the Special Protocol Assessment (SPA) with the FDA is expected to mitigate some risks.
Financial Constraints: Brainstorm Cell Therapeutics is experiencing significant financial constraints, which could impact the initiation and execution of the clinical trial.
Funding Challenges: Securing adequate funding is essential for the commencement of the trial, with ongoing negotiations for a $15 million non-dilutive grant and strategic partnerships.
Supply Chain Risks: The company is expanding its manufacturing footprint in the U.S. to ensure supply chain security, which is critical for the production of NurOwn.
Competitive Pressures: The company operates in a highly competitive environment for ALS treatments, which may affect its market position and ability to attract partnerships.
Clinical Trial Risks: The success of the Phase 3b trial is uncertain, and the company must meet pre-specified expectations to support regulatory approval.
Market Risks: The overall market potential for ALS treatments is uncertain, influenced by the limited treatment options currently available and the evolving landscape of neurodegenerative disorder therapies.
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Guidance & Outlook
Clinical Development Plan: The primary focus remains the execution of the clinical development plan for NurOwn and the initiation of the pivotal Phase 3b trial for ALS.
Regulatory Milestone: The U.S. 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 Sourasky Medical Center and proceed with technology transfer to Pluri for additional cleanroom facilities.
Strategic Partnerships: The company is actively pursuing strategic partnerships and funding opportunities to secure necessary capital for the trial.
Exosome Program: The exosome program is showing promising preclinical data, and the company is pursuing strategic partnerships for clinical development.
Funding Expectations: The company is pursuing a promising $15 million non-dilutive grant and ongoing negotiations for strategic partnerships.
Trial Enrollment: The company is focused on completing necessary steps to initiate the trial as swiftly as responsibly possible.
Financial Constraints: Despite financial constraints, the company has made significant strides in preparing for the trial.
Trial Name Significance: The trial is named ENDURANCE to resonate with the ALS community and reflect the company's commitment to delivering a therapeutic option.
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Shareholder Return Plan
Funding Opportunities: The company is actively pursuing multiple funding avenues, including a promising $15 million non-dilutive grant currently under review and ongoing negotiations for strategic partnerships.
Shareholder Return Plan: Securing proper funding is essential to commence the trial, indicating a focus on maintaining shareholder value through successful trial execution.
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Key Q&A
Q:Have you had any communications with FDA in terms of being able to stratify by UNC13A in the upcoming Phase 3b?
A:The FDA is not yet approving any biomarker as a surrogate. Under the Special Protocol Assessment agreement, the protocol is agreed upon, but changes can be made with discussions. The UNC13A story remains exploratory and not definitive.
Q:Did you say that it restored normoxic activity? Can that mechanism of action be used as part of a data package when you refile the BLA?
A:Yes, the media enriched by our cells had a protective effect under hypoxic conditions, restoring them to almost 100% of normoxic condition. This is supportive but is a simplistic model.
Q:How many therapies can the Tel Aviv facility currently handle or produce?
A:It depends on how many rules we’re using. It will be a rolling enrollment, and we’ll start with Pluri as specified before. The U.S. site will also be up and running next year.
Q:Are you looking to open up 15 clinical trial sites? What needs to occur to get those sites up and running?
A:Yes, we are looking to open 15 sites. We haven’t signed the CTAs yet, but we will announce them soon. The enrollment will depend on the manufacturing capacity, but I can’t share exact numbers now.
Q:Review of Unclear Management Responses
A:Management avoided giving a direct answer regarding the exact number of patients that can be enrolled per month based on manufacturing capacity, stating they 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
ALS Summit
ALS community
Blondheim Shraga
Brainstorm Cell
CD cell
CSF sample
Chaim Haro
Development
Dr Blondheim
Dr Dagher
EAP
Executive
FDA inspection
NfL level
NurOwn cell
NurOwn reduction
Officer Dr
Patients
Phase study
President Chief
Vice President
biomarkers ALS
detail
exosomes
individual
lung
option ALS
presentation
press release
response NurOwn
trial ENDURANCE
BCLI Transcript
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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
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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
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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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