Brainstorm Cell Therapeutics Inc. (BCLI) Q2 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
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.
Key Financial Performance
Research and Development Expenditures $1.1 million for Q2 2025, compared to $0.9 million for Q2 2024, representing an increase. The increase is likely due to advancing the Phase IIIb clinical trial and related activities.
General and Administrative Expenses $1.4 million for Q2 2025, compared to $2.1 million for Q2 2024, representing a decrease. The decrease may be attributed to cost-cutting measures or operational efficiencies.
Net Loss $2.9 million or $0.34 per share for Q2 2025, compared to $2.5 million or $0.60 per share for Q2 2024, representing an increase in net loss. This could be due to higher R&D expenditures and other operational costs.
Cash, Cash Equivalents, and Restricted Cash Approximately $1 million as of June 30, 2025. No year-over-year comparison provided, but the low cash balance highlights the company's funding challenges.
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Operating Highlights
NurOwn Phase IIIb Trial: The company is advancing NurOwn into a planned Phase IIIb clinical trial called ENDURANCE, designed to confirm its therapeutic benefit in early-stage ALS patients. The trial has received FDA clearance and is supported by a Special Protocol Assessment (SPA).
Manufacturing Partnerships: Brainstorm has partnered with Minaris Advanced Therapies in the U.S. and Pluri Inc. in Israel to enhance manufacturing capabilities for the trial.
Regulatory Developments: A citizens petition was filed with the FDA by ALS patients and families, requesting a de novo review of NurOwn data. This could potentially lead to accelerated approval pathways.
Financial Position: Research and development expenses increased to $1.1 million in Q2 2025 from $0.9 million in Q2 2024. General and administrative expenses decreased to $1.4 million from $2.1 million in the same period. The company reported a net loss of $2.9 million for Q2 2025.
Funding Challenges: The company faced challenges in securing funding due to the regulatory dynamics created by the citizens petition, impacting its ability to initiate the Phase IIIb trial and meet NASDAQ listing requirements.
NASDAQ Relisting: The company transitioned to OTCQB due to noncompliance with NASDAQ's minimum shareholder equity requirement but aims to regain compliance and relist.
Long-term Vision: Brainstorm is focused on advancing NurOwn for ALS and exploring its potential for other neurodegenerative diseases like MS, Parkinson's, and Huntington's.
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Risk or Challenges
Regulatory Challenges: The company faces regulatory uncertainty due to the filing of a citizens petition with the FDA, which has created a new regulatory dynamic and delayed funding efforts. This has impacted the initiation of the Phase IIIb trial.
Funding Constraints: The company has been unable to secure the necessary funding to initiate the Phase IIIb trial and meet NASDAQ's minimum shareholder equity requirements. This has also delayed the application for nondilutive funding due to insufficient co-funding.
Stock Listing Downgrade: The company's stock transitioned from NASDAQ to OTCQB due to noncompliance with NASDAQ's minimum shareholder equity requirement. This could impact investor confidence and access to capital.
Operational Delays: The initiation of the Phase IIIb trial has been delayed due to funding and regulatory challenges, which could slow down the development and approval of NurOwn.
Market and Investor Sentiment: The citizens petition has led key investors to adopt a wait-and-see approach, further complicating the company's ability to secure funding.
Cash Flow Concerns: The company reported cash, cash equivalents, and restricted cash of only $1 million as of June 30, 2025, raising concerns about its ability to sustain operations without additional funding.
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Guidance & Outlook
Advancement of NurOwn into Phase IIIb Clinical Trial: The company plans to initiate the Phase IIIb clinical trial named ENDURANCE to confirm the therapeutic benefit of NurOwn in early-stage ALS patients. The trial has received FDA clearance and is designed under a Special Protocol Assessment (SPA) to support a future Biologics License Application (BLA).
Manufacturing Preparations: Brainstorm has partnered with Minaris Advanced Therapies and Pluri Inc. to establish a robust manufacturing network for the clinical trial. Technology transfer and manufacturing preparations are underway.
Regulatory Developments: A citizens petition has been filed with the FDA requesting a de novo review of NurOwn data. The company supports this initiative and believes it could lead to accelerated approval pathways.
Funding and Trial Initiation: The initiation of the Phase IIIb trial is contingent on securing significant funding. The company is actively exploring alternative funding sources and remains ready to proceed once funding is secured.
NASDAQ Relisting: Brainstorm aims to regain compliance and relist on NASDAQ, linking this objective to the successful initiation of the Phase IIIb trial and potential positive regulatory outcomes.
Expansion Beyond ALS: NurOwn is being explored as a platform product for other neurodegenerative diseases, including progressive MS, Parkinson's, and Huntington's, with promising preclinical and expanded access program data.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:What are the potential outcomes from the Citizens petition filing for the company?
A:If the FDA finds the Citizens petition attractive and invites the company to file a BLA, it would be an exciting outcome. The company believes the BLA should be approved under conditions of a confirmatory trial, such as a Phase IV or Phase IIIb trial.
Q:Why is the 5-year survival data from the EAP study important, and is it due to early disease stages or the treatment itself?
A:The 5-year survival data is impressive, showing 10 out of 10 patients alive after 5 years and 6 out of 10 after 7 years without tracheostomy or invasive support. This data is considered unprecedented and provides real-world evidence beyond the initial 6-month study. The company plans to focus on long-term survival and early disease outcomes in the next Phase IIIb study.
Q:What is the distinction between the Citizens petition and broader public support or demand for NurOwn approval?
A:The Citizens petition is a regulatory pathway requiring the FDA to respond, unlike broader public support. The petition includes over 300 pages of evidence, including real-world data from patients and families, which the company cannot collect post-trial. The company’s clinical development plans remain unchanged, focusing on the SPA-agreed Phase IIIb confirmatory study.
Q:Is the FDA open to looking beyond ALSFRS scores as a gold standard endpoint?
A:The FDA still considers ALSFRS-R scores as the gold standard endpoint, as agreed in the SPA protocol. While there is interest in alternative measures like biomarkers, quality of life, and survival, these are currently exploratory endpoints. The company plans to use ALSFRS-R as the primary endpoint in the confirmatory study.
Q:What is the significance of the Right to Try law and the case of Matt, a patient who received NurOwn under this law?
A:Matt, a Navy pilot diagnosed with ALS, received 7 doses of NurOwn under the Right to Try law. His case showed significant improvements, including regaining 6 points on the ALSFRS-R score, standing unassisted, and breathing without a BiPAP. His evidence supports the effectiveness of NurOwn and highlights the importance of considering real-world data in FDA evaluations.
Q:Review of Unclear Management Responses
A:Management avoided directly addressing the question about whether the FDA is open to looking beyond ALSFRS scores as a gold standard endpoint. While they acknowledged discussions in the field about alternative measures, they emphasized that ALSFRS-R remains the primary endpoint under the current SPA protocol, without providing clarity on whether the FDA might consider other measures in the future.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
Act
Advisors
Brainstorm Cell
Chaim President
Conference
Executive Vice
IIIb trial
Inc
Interim
Minaris
Phase IIIb
President CEO
President Chief
Vice President
access
application funding
citizen petition
co funding
compliance
equity requirement
funding application
investor
loss share
need
patient ALS
petition FDA
priority NurOwn
reminder
review
shareholder equity
trial Brainstorm
trial ENDURANCE
trial NASDAQ
BCLI Transcript
Brainstorm Cell Therapeutics Inc. (BCLI) Q2 2025 Earnings Call 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.
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BCLI Report
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