BrainStorm Cell Therapeutics Provides Q2 2025 Financial Update
Today, BrainStorm Cell Therapeutics Inc. (BCLI), a frontrunner in developing adult stem cell therapies for neurodegenerative diseases, announced its financial outcomes for the second quarter ending June 30, 2025, along with recent corporate updates.
Key Corporate Milestones Achieved
Chaim Lebovits, President and CEO, expressed confidence in advancing the clinical development plan for NurOwn. "During the second quarter, we achieved significant progress by receiving FDA clearance to begin our Phase 3b trial, which aims to gather confirmatory data supporting a future BLA submission," he stated. This trial represents a critical step in the development of NurOwn, designed specifically for ALS treatment. Additionally, BrainStorm has been actively engaging with clinical sites and their CDMO partners to ensure they are prepared for clinical drug supply.
FDA Citizen Petition Support
Mr. Lebovits further commented on their supportive stance towards the FDA's consideration of a Citizen Petition from the ALS community, which advocates for re-evaluating the scientific evidence surrounding NurOwn. The company is committed to maintaining the integrity of their data and fostering collaboration with clinicians and the ALS community.
Recent Highlights
The following noteworthy achievements were highlighted:
- Phase 3b Trial Clearance: The FDA has authorized the company to launch the Phase 3b clinical trial for NurOwn. The trial, known as ENDURANCE, will recruit around 200 participants at renowned academic medical centers. This double-blind trial will have a 24-week duration, followed by an open-label extension phase for all participants.
- Citizen Petition Submission: The ALS community's Citizen Petition submitted to the FDA seeks a comprehensive reassessment of previous NurOwn data, marking a fresh evaluation of the therapeutic.
- Impressive Survival Rates: Recent survival statistics from the NurOwn Expanded Access Program demonstrated that all participants lived over five years post-ALS symptom onset, a stark contrast to the estimated survival of merely 10% in ALS patients.
- Manufacturing Partnership: BrainStorm entered a Letter of Intent with Minaris Advanced Therapies, ensuring reliable manufacture of NurOwn for the imminent Phase 3b clinical trial.
- Scientific Presentation: New pharmacogenomic data revealing the impact of UNC13A genotype on clinical outcomes were successfully showcased during an oral presentation at the ISCT 2025 Meeting.
Financial Overview for Q2 2025
The financial report provided an overview of the company's current economic state:
- As of June 30, 2025, the company had approximately $1.03 million in cash equivalents and restricted cash.
- Research and development expenses for the quarter totaled around $1.1 million, an increase from $0.9 million in the previous year.
- General and administrative costs reduced to $1.4 million compared to $2.1 million in Q2 2024.
- Net loss for Q2 2025 was approximately $2.9 million, relative to a net loss of $2.5 million in Q2 2024.
- Loss per share for the current and prior year quarter was $0.34 and $0.60, respectively.
Upcoming Conference Call and Webcast
BrainStorm will hold a conference call and webcast at 8:30 a.m. Eastern Time, today, to provide further details on the financial results and future plans. Interested participants can join using the following details:
Participant Access Information:
Toll Free: 877-545-0320
International: 973-528-0002
Access Code: 601260
About BrainStorm Cell Therapeutics
BrainStorm Cell Therapeutics Inc., trading under the ticker symbol BCLI, specializes in developing innovative therapies derived from autologous adult stem cells to target debilitating neurodegenerative diseases. The NurOwn platform, designed to harness body resources for neuroprotection and nerve restoration, is at the forefront of their efforts in treating conditions such as ALS and multiple sclerosis. With a dedicated clinical program, BrainStorm aims to provide beneficial solutions for patients.
Frequently Asked Questions
What is the significance of the Phase 3b trial for NurOwn?
The Phase 3b trial is crucial for gathering additional data that could support the submission of a Biologics License Application (BLA) for NurOwn, potentially leading to its approval as a treatment for ALS.
How does the recent Citizen Petition impact the NurOwn data?
The Citizen Petition proposes a reconsideration of the existing data on NurOwn, providing an opportunity for the FDA to reassess its therapeutic potential objectively.
What are the expected outcomes of the ENDURANCE trial?
The primary endpoint is the change in ALS Functional Rating Scale-Revised (ALSFRS-R) scores from baseline to week 24, which will help determine the efficacy of NurOwn in ALS patients.
What are BrainStorm's financial results for Q2 2025?
BrainStorm reported a net loss of approximately $2.9 million, with total cash and equivalents around $1.03 million, emphasizing the need for strategic financial planning.
How can I access the conference call and webcast?
Participants can join the conference call at 8:30 a.m. ET using the provided toll-free and international numbers, along with the given access code.
