BrainStorm Overview
BrainStorm Cell Therapeutics is pioneering the field of neurodegenerative disease treatment with a strong focus on amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). At the heart of BrainStorm's innovative approach is NurOwn®, a breakthrough technology that transforms autologous mesenchymal stem cells into neurotrophic factor-secreting cells. This unique process is designed to deliver critical growth factors directly to areas affected by neurodegenerative conditions, offering new hope for patients with ALS and MS. Recent strategic developments at BrainStorm highlight the company's commitment to overcoming the challenges of neurodegenerative diseases. Through ongoing engagement with regulatory authorities, BrainStorm is dedicated to advancing NurOwn® and ensuring it meets the rigorous standards for efficacy and safety. The company's proactive and collaborative approach with regulatory bodies underscores its dedication to bringing NurOwn® to patients in need. In response to the evolving landscape of therapeutic development, BrainStorm has undertaken a strategic realignment to accelerate the development of NurOwn® for both ALS and MS. This includes streamlining operations and focusing resources on critical aspects of clinical trials and regulatory submissions, ensuring that BrainStorm remains at the forefront of innovation in treating neurodegenerative diseases. For the latest information on BrainStorm's efforts and developments in ALS and MS treatment, please visit the BrainStorm [website](https://www.ir.brainstorm-cell.com) or review detailed articles from reputable news sources that cover these significant advancements.
Cumulative Funding Raised Over Time ($)
$5.0MJul 2012
$15.5MJun 2014
$25.5MMar 2020
$27.1MMay 2014
Latest News
growth-positive
BCLI: Focused on Initiation of Phase 3b ENDURANCE Trial of NurOwn® in ALS…
BrainStorm Cell Therapeutics, Inc. is advancing its NurOwn® treatment for amyotrophic lateral sclerosis (ALS) into a Phase 3b ENDURANCE trial. The company received FDA clearance in May 2025 to conduct the trial, following an IND amendment. The trial, designed in consultation with the FDA under a Special Protocol Assessment (SPA), will enroll up to 200 patients with mild-to-moderate ALS. It consists of a 24-week randomized, double-blind, placebo-controlled period followed by a 24-week open-label extension. The trial aims to improve upon the previous Phase 3 trial by focusing on earlier-stage ALS patients and utilizing a more standardized primary endpoint. The SPA agreement with the FDA is a significant advancement from the first Phase 3 trial.
Product StageFDA approved/pending approval
growth-positive
BrainStorm Cell Therapeutics Announces Second Quarter 2025 Financial Results and Provides Corporate Update
BrainStorm Cell Therapeutics Inc. announced its financial results for Q2 2025 and provided a corporate update. The company received FDA clearance to initiate a Phase 3b clinical trial for its NurOwn® therapy for ALS, marking a significant milestone. The trial, named ENDURANCE, will enroll around 200 participants and aims to generate data to support a BLA submission. BrainStorm has also signed a Letter of Intent with Minaris Advanced Therapies for manufacturing NurOwn for the trial. New survival data from the NurOwn Expanded Access Program showed promising results, with 100% of participants surviving more than five years from ALS symptom onset. The companys data was also selected for presentation at the ISCT 2025 Meeting.
Product StagePartners
growth-positive
/PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced...
BrainStorm Cell Therapeutics Inc., a leader in developing adult stem cell therapies for neurodegenerative diseases, announced a conference call scheduled for August 14, 2025, to update shareholders on the second quarter financial results. The call will feature key executives, including the President and CEO, Chaim Lebovits. BrainStorms lead investigational therapy, NurOwn®, for ALS, has completed a Phase 3 trial and is set to launch a Phase 3b trial under a Special Protocol Assessment with the FDA. The company has also completed a Phase 2 trial for progressive multiple sclerosis and is advancing an exosome-based platform. The NurOwn® platform has received Orphan Drug designation from the FDA and EMA. BrainStorm is strengthening its IP portfolio with a new patent for its exosome technology.
Product StageFDA approved/pending approval
growth-positive
BrainStorm to Announce Second Quarter Financial Results and Provide a Corporate Update
BrainStorm Cell Therapeutics Inc., a developer of adult stem cell therapeutics for neurodegenerative diseases, announced a conference call and webcast scheduled for August 14, 2025. The call aims to update shareholders on the companys financial results for the second quarter of 2025. Key executives, including President and CEO Chaim Lebovits, will participate in the call, which will feature a Q&A session with the investment community. Participants are encouraged to submit questions in advance. The replay of the conference call will be available until August 28, 2026.
growth-negative
BrainStorm Cell Therapeutics Announces Nasdaq Delisting and Transition to OTCQB
BrainStorm Cell Therapeutics Inc. announced that its common stock will be delisted from the Nasdaq Capital Market due to non-compliance with the minimum shareholder equity requirement. Trading will be suspended on July 18, 2025. The company has secured approval for its stock to be quoted on the OTCQB Venture Market, ensuring continuous trading under the same symbol, BCLI. Despite the delisting, BrainStorm remains committed to advancing its NurOwn technology for ALS patients and is preparing for a pivotal Phase 3b trial under an SPA agreement with the FDA. The delisting does not affect the companys operations or research and development efforts.
| Sector | Health Tech & Life Sciences |
Funding
| Total funding | $55.23M |
| Last funding | $500K |
| Stage | Public |
| Rounds | 14 |
| Investors | 3 |
Team Members
10
Employees: 11-50
Web & Social Links
| Website | brainstorm-cell.com |
| Careers | Careers page |
Locations
Basel Street 12, Petah Tiqwa, Israel
1325 Avenue of the Americas, Manhattan, New York, NY 10019, USA
Photos & Videos
2 item(s)
BrainStorm Business
Business models
B2B
Product stage
Clinical Trial
Employees
11-50
Sector
Health Tech & Life SciencesPharma & Medical BiotechnologyDrugs Discovery & DevelopmentTarget Customer
Healthcare & Life SciencesHealthcareProvidersPatientsLife SciencesBiotechnologyPharmaceuticalsCore Technology
BiologicalsCellsTags (13)
degenerative-diseasesstem-cellstherapeuticsbiotechnologyneurologyhospitalsparkinsoncell-therapymedical-technologiesautismcns-disordersdrug-discoverymultiple-sclerosisGeographic Markets
JapanUnited StatesBrainStorm Financials
$55.23M
Total funding
Undisclosed
Capital raised
$500K
Last funding
Public
Funding stage
14
Total rounds
3
Investors
Cumulative Funding Raised Over Time ($)
$5.0MJul 2012
$15.5MJun 2014
$25.5MMar 2020
$27.1MMay 2014
Private Equity Funding
PIPE
Mar 2020
$10M
ABBHI INVESTMENTS, LLC
PIPE
Jun 2014
$10.5M
Post IPO Debt Capital
PIPE
May 2014
$1.63M
SEC Investors
PIPE
Jul 2012
$5M
Post IPO Debt Capital
Non-Equity Funding
GrantEvent
Jun 2020
$500K
I AM ALS, The ALS Association
GrantEvent
Apr 2020
$1.5M
Israel Innovation Authority
GrantEvent
Nov 2019
$495.33K
National Multiple Sclerosis Society
GrantEvent
Jul 2017
$16M
California Institute for Regenerative Medicine (CIRM)
GrantEvent
Jun 2017
$2.1M
Israel Innovation Authority
GrantEvent
Dec 2014
$1.1M
Office of the Chief Scientist
GrantEvent
Jul 2014
$5M
Brazilian Ministry of Health
GrantEvent
Feb 2014
$600K
GrantEvent
Dec 2013
$800K
Public Offering / Exit
POEvent
Oct 2003
Undisclosed
BrainStorm Lifecycle
Cumulative Funding Raised Over Time
$5.0MJul 2012
$15.5MJun 2014
$25.5MMar 2020
$27.1MMay 2014
All Events
PIPE
Mar 2020
$10M
ABBHI INVESTMENTS, LLC
PIPE
Jun 2014
$10.5M
Post IPO Debt Capital
PIPE
May 2014
$1.63M
SEC Investors
PIPE
Jul 2012
$5M
Post IPO Debt Capital
GrantEvent
Jun 2020
$500K
I AM ALS, The ALS Association
GrantEvent
Apr 2020
$1.5M
Israel Innovation Authority
GrantEvent
Nov 2019
$495.33K
National Multiple Sclerosis Society
GrantEvent
Jul 2017
$16M
California Institute for Regenerative Medicine (CIRM)
GrantEvent
Jun 2017
$2.1M
Israel Innovation Authority
GrantEvent
Dec 2014
$1.1M
Office of the Chief Scientist
GrantEvent
Jul 2014
$5M
Brazilian Ministry of Health
GrantEvent
Feb 2014
$600K
GrantEvent
Dec 2013
$800K
POEvent
Oct 2003
Undisclosed
BrainStorm News
166 articles
growth-positive
BCLI: Focused on Initiation of Phase 3b ENDURANCE Trial of NurOwn® in ALS…
BrainStorm Cell Therapeutics, Inc. is advancing its NurOwn® treatment for amyotrophic lateral sclerosis (ALS) into a Phase 3b ENDURANCE trial. The company received FDA clearance in May 2025 to conduct the trial, following an IND amendment. The trial, designed in consultation with the FDA under a Special Protocol Assessment (SPA), will enroll up to 200 patients with mild-to-moderate ALS. It consists of a 24-week randomized, double-blind, placebo-controlled period followed by a 24-week open-label extension. The trial aims to improve upon the previous Phase 3 trial by focusing on earlier-stage ALS patients and utilizing a more standardized primary endpoint. The SPA agreement with the FDA is a significant advancement from the first Phase 3 trial.
Product StageFDA approved/pending approval
growth-positive
BrainStorm Cell Therapeutics Announces Second Quarter 2025 Financial Results and Provides Corporate Update
BrainStorm Cell Therapeutics Inc. announced its financial results for Q2 2025 and provided a corporate update. The company received FDA clearance to initiate a Phase 3b clinical trial for its NurOwn® therapy for ALS, marking a significant milestone. The trial, named ENDURANCE, will enroll around 200 participants and aims to generate data to support a BLA submission. BrainStorm has also signed a Letter of Intent with Minaris Advanced Therapies for manufacturing NurOwn for the trial. New survival data from the NurOwn Expanded Access Program showed promising results, with 100% of participants surviving more than five years from ALS symptom onset. The companys data was also selected for presentation at the ISCT 2025 Meeting.
Product StagePartners
growth-positive
/PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced...
BrainStorm Cell Therapeutics Inc., a leader in developing adult stem cell therapies for neurodegenerative diseases, announced a conference call scheduled for August 14, 2025, to update shareholders on the second quarter financial results. The call will feature key executives, including the President and CEO, Chaim Lebovits. BrainStorms lead investigational therapy, NurOwn®, for ALS, has completed a Phase 3 trial and is set to launch a Phase 3b trial under a Special Protocol Assessment with the FDA. The company has also completed a Phase 2 trial for progressive multiple sclerosis and is advancing an exosome-based platform. The NurOwn® platform has received Orphan Drug designation from the FDA and EMA. BrainStorm is strengthening its IP portfolio with a new patent for its exosome technology.
Product StageFDA approved/pending approval
growth-positive
BrainStorm to Announce Second Quarter Financial Results and Provide a Corporate Update
BrainStorm Cell Therapeutics Inc., a developer of adult stem cell therapeutics for neurodegenerative diseases, announced a conference call and webcast scheduled for August 14, 2025. The call aims to update shareholders on the companys financial results for the second quarter of 2025. Key executives, including President and CEO Chaim Lebovits, will participate in the call, which will feature a Q&A session with the investment community. Participants are encouraged to submit questions in advance. The replay of the conference call will be available until August 28, 2026.
growth-negative
BrainStorm Cell Therapeutics Announces Nasdaq Delisting and Transition to OTCQB
BrainStorm Cell Therapeutics Inc. announced that its common stock will be delisted from the Nasdaq Capital Market due to non-compliance with the minimum shareholder equity requirement. Trading will be suspended on July 18, 2025. The company has secured approval for its stock to be quoted on the OTCQB Venture Market, ensuring continuous trading under the same symbol, BCLI. Despite the delisting, BrainStorm remains committed to advancing its NurOwn technology for ALS patients and is preparing for a pivotal Phase 3b trial under an SPA agreement with the FDA. The delisting does not affect the companys operations or research and development efforts.
growth-negative
NEW YORK, July 17, 2025 BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) today announced that it has received a delisting notification from The Nasdaq Stock...
BrainStorm Cell Therapeutics Inc. announced it received a delisting notification from Nasdaq due to non-compliance with the minimum shareholder equity requirement. Trading of its common stock will be suspended on July 18, 2025, but the company has secured approval for its stock to be quoted on the OTCQB Venture Market. Despite the delisting, BrainStorm remains committed to its core mission of advancing NurOwn for ALS patients and will continue its scientific and clinical programs, including a pivotal Phase 3b trial under a Special Protocol Assessment agreement with the FDA. The company emphasizes that the delisting does not impact its business operations or ongoing research and development efforts.
Public Trading
growth-positive
FDA Review of Citizen Petition Offers a Fresh Look at NurOwn®'s Evidence of Treatment Effectiveness
BrainStorm Cell Therapeutics Inc. is advancing its Phase 3b trial for NurOwn, a therapy for ALS, while welcoming the FDAs consideration of a Citizen Petition to review its data. The company supports the integrity of its data and is committed to working with the FDA to ensure the therapys efficacy and safety. BrainStorm aims to generate additional data under an FDA Special Protocol Assessment and explore regulatory pathways for broader access to NurOwn. The companys leadership emphasizes the importance of rigorous science and collaboration with the ALS community.
Product Stage
growth-positive
BCLI: Citizen’s Petition Filed Requesting the FDA Approve NurOwn™…
A Citizen’s Petition was filed on July 3, 2025, with the FDA by a group of ALS patients requesting the approval of NurOwn, a treatment developed by BrainStorm Cell Therapeutics, Inc. The petition urges the FDA to invite the company to re-submit its Biologics License Application and consider granting Accelerated or Conditional Approval for NurOwn, contingent on a Phase 4 confirmatory study. The petition includes extensive data showing significant improvements in survival and disease progression for ALS patients treated with NurOwn. BrainStorm Cell Therapeutics was not involved in the petitions creation but acknowledges the potential positive impact of the data presented.
growth-positive
/PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today...
BrainStorm Cell Therapeutics Inc. announced promising survival data from its Expanded Access Program (EAP) for NurOwn, a stem cell therapy for ALS. The data showed that 90% of participants survived more than five years from ALS symptom onset, significantly higher than typical survival rates. This supports the upcoming Phase 3b clinical trial under an FDA Special Protocol Assessment. NurOwn uses autologous MSC-NTF cells to deliver neurotrophic factors and immunomodulatory cytokines to slow disease progression. The company has also completed a Phase 2 trial for multiple sclerosis and is advancing an exosome-based platform. BrainStorms NurOwn has received Orphan Drug designation from the FDA and EMA.
Product StageFDA approved/pending approval
growth-positive
BrainStorm Announces New Survival Data from Expanded Access Program Cohort: Remarkably 90% of ALS Patients Survived Over 5 Years with NurOwn®
BrainStorm Cell Therapeutics Inc. announced promising survival data from its Expanded Access Program (EAP) for NurOwn, a stem cell therapy for ALS. The data showed that 90% of participants survived more than five years from ALS symptom onset, significantly higher than typical survival rates. This suggests that the survival outcomes are unlikely due to random variation. The findings support the upcoming Phase 3b clinical trial of NurOwn, which will be conducted under an FDA Special Protocol Assessment. The company aims to generate conclusive data to demonstrate the therapys benefits for ALS patients.
Product Stage
growth-positive
BrainStorm Cell Therapeutics and Minaris partner on manufacturing NurOwn for trial
BrainStorm Cell Therapeutics, a US-based biotechnology company, has partnered with Minaris Advanced Therapies to enhance its domestic manufacturing capabilities for the NurOwn technology platform. This collaboration supports BrainStorms preparation for a planned Phase IIIb trial aimed at treating amyotrophic lateral sclerosis (ALS). The US FDA has granted clearance for this trial, and the platform has orphan drug designation from both the EMA and the US FDA. The partnership with Minaris, along with a recent collaboration with Israeli company Pluri, is part of BrainStorms strategy to create a robust manufacturing network for NurOwns clinical development.
Product StagePartners
growth-positive
BrainStorm Secures Key Manufacturing Partnership with Minaris for Upcoming NurOwn® Phase 3b ALS Clinical Trials
BrainStorm Cell Therapeutics Inc. has signed a Letter of Intent with Minaris Advanced Therapies to manufacture NurOwn® for its upcoming Phase 3b clinical trial. This strategic partnership will facilitate the technology transfer of NurOwn® to Minaris facility in New Jersey, enhancing BrainStorms U.S. manufacturing capabilities. The collaboration is part of BrainStorms broader strategy to build a robust manufacturing network, which also includes a partnership with Pluri Inc. in Israel. These efforts are aimed at advancing the clinical development of NurOwn®, a promising investigational therapy for neurodegenerative diseases. The partnership reflects BrainStorms commitment to the ALS community and its focus on developing therapies that can significantly impact patients lives.
PartnersProduct Stage
growth-positive
BCLI: Receives Regulatory Clearance to Initiate Phase 3b ALS Trial…
BrainStorm Cell Therapeutics, Inc. has received FDA clearance to initiate a Phase 3b trial for its NurOwn® treatment targeting amyotrophic lateral sclerosis (ALS). The trial, named ENDURANCE, will enroll up to 200 patients with mild-to-moderate ALS and will consist of a 24-week randomized, double-blind, placebo-controlled period followed by a 24-week open-label extension. The trial design was developed in consultation with the FDA under a Special Protocol Assessment. This new trial will focus on earlier-stage ALS patients and aims to use the change in ALSFRS-R from baseline to Week 24 as the primary endpoint, considered the gold standard for ALS trials.
Product Stage
growth-positive
/PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today...
BrainStorm Cell Therapeutics Inc. has announced a strategic partnership with Minaris Advanced Therapies to manufacture NurOwn® for an upcoming Phase 3b clinical trial. This collaboration aims to enhance BrainStorms manufacturing capabilities in the U.S. and support the clinical development of NurOwn®, an investigational therapy for amyotrophic lateral sclerosis (ALS). The partnership with Minaris, along with a collaboration with Pluri Inc. in Israel, strengthens BrainStorms manufacturing network. NurOwn® has received Orphan Drug designation from the FDA and EMA, and the company is preparing for a new trial under a Special Protocol Assessment agreement with the FDA. BrainStorm is also advancing its exosome-based platform and has recently received a patent notice for its exosome technology.
Product StagePartners
growth-positive
Q1 2025 Brainstorm Cell Therapeutics Inc Earnings Call
Brainstorm Cell Therapeutics Inc. held a conference call to discuss their Q1 2025 earnings and corporate updates. The company announced that the U.S. FDA has cleared them to initiate a pivotal phase 3B trial for their neuron technology platform, aimed at treating early-stage ALS. This clearance follows amendments to their investigational new drug application and marks a significant milestone in their clinical development plan. The trial design has been agreed upon with the FDA under a special protocol assessment, which is crucial for regulatory approval. The company is focused on operational readiness for the upcoming trial, with a strong emphasis on quality assurance and control processes.
Product StageFDA approved/pending approval
growth-positive
Brainstorm Cell Therapeutics Inc (BCLI) Q1 2025 Earnings Call Highlights: Pivotal Phase 3b ...
Brainstorm Cell Therapeutics Inc has received FDA clearance to initiate a pivotal Phase 3b trial for its ALS treatment, NurOwn. This marks a significant milestone in their development process. The trial design has been agreed upon with the FDA, reducing regulatory risks. The company is negotiating with 15 leading U.S. clinical centers for trial sites and has secured a leading clinical site that passed FDA inspection. Brainstorm is pursuing multiple funding avenues, including a $15 million non-dilutive grant, to support the trial. However, financial constraints and limited manufacturing capacity pose challenges. The company is expanding its manufacturing footprint to the U.S. and seeks strategic partnerships for its exosome program, which is still in the preclinical stage.
Product StageInvestment
growth-positive
FDA grants clearance to BrainStorm’s Phase IIIb trial of ALS treatment
BrainStorm Cell Therapeutics has received FDA clearance to commence a Phase IIIb trial for its NurOwn therapy aimed at treating amyotrophic lateral sclerosis (ALS). The trial will involve approximately 200 subjects and will assess changes in ALS Functional Rating Scale-Revised scores over 24 weeks. The therapy uses autologous MSCs to produce NTF-secreting cells, targeting neuroinflammation and neuroprotection. The company has secured orphan drug designations from both the FDA and the European Medicines Agency. BrainStorm is also exploring funding options, including non-dilutive grants, to support the trials launch.
Product StageInvestment
growth-positive
Sector Update: Health Care Stocks Advance Monday Afternoon
The article reports on the positive performance of healthcare stocks on a Monday afternoon, with the NYSE Health Care Index and the Health Care Select sector showing advances. The article is part of MT Newswires, which provides premium news articles requiring a Silver or Gold subscription plan for access. The focus is on the stock market, particularly healthcare stocks, and the article suggests a growth-positive impact on the sector. No specific companies, customers, or partners are mentioned, and there are no details on investments, acquisitions, or layoffs.
growth-positive
/PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today...
BrainStorm Cell Therapeutics Inc. has received FDA clearance to initiate a Phase 3b clinical trial for its NurOwn® therapy aimed at treating amyotrophic lateral sclerosis (ALS). This marks a significant milestone for the company, allowing it to proceed with patient enrollment and activate clinical sites. The trial will involve approximately 200 participants and will be conducted at leading academic medical centers. BrainStorm is also seeking funding through non-dilutive grants to support the trial. The company is a leader in developing autologous adult stem cell therapies for neurodegenerative diseases and has received Orphan Drug designation for NurOwn® from both the FDA and EMA.
Product StageInvestment
growth-positive
BrainStorm Receives FDA Clearance to Initiate Phase 3b Trial of NurOwn® for ALS
BrainStorm Cell Therapeutics Inc. announced that the FDA has cleared the company to initiate its Phase 3b clinical trial of NurOwn® for treating amyotrophic lateral sclerosis (ALS). This clearance is a significant milestone, allowing the company to proceed with patient enrollment and activate clinical sites. The trial will enroll approximately 200 participants and will consist of a 24-week randomized, double-blind, placebo-controlled phase followed by a 24-week open-label extension. BrainStorm is also working to secure funding through various avenues to ensure the successful launch of the study.
Product StageInvestment
growth-positive
BrainStorm Reschedules First Quarter 2025 Financial Results Release to Post-Market Close Today and Sets Investor Call for Monday, May 19
BrainStorm Cell Therapeutics Inc., a leader in developing adult stem cell therapies for neurodegenerative diseases, announced the rescheduling of its financial results release for Q1 2025 to May 15, 2025, and its investor conference call to May 19, 2025. The company is advancing its NurOwn® platform, which uses autologous mesenchymal stem cells for treating ALS, having completed a Phase 3 trial and preparing for a Phase 3b trial under an FDA Special Protocol Assessment. The company has also completed a Phase 2 trial for progressive multiple sclerosis and is developing an exosome-based platform for regenerative medicine. BrainStorm has received Orphan Drug designation from the FDA and EMA and continues to strengthen its intellectual property portfolio.
Product StageInvestment
growth-positive
BrainStorm Cell Therapeutics Announces First Quarter 2025 Financial Results and Provides Corporate Update
BrainStorm Cell Therapeutics Inc. announced its financial results for Q1 2025 and provided a corporate update. The company is advancing its NurOwn® development program, focusing on a Phase 3b trial for ALS patients. An IND amendment was submitted to the FDA, marking a significant milestone towards initiating the trial. The trial, designed with the FDA under a Special Protocol Assessment, aims to enroll 200 early-stage ALS participants. Recent presentations at the ISCT 2025 Meeting and ALS Drug Development Summit highlighted NurOwns clinical impact and biomarker insights. The company is finalizing clinical trial agreements and manufacturing steps, with a clear path forward supported by the ALS community.
Product Stage
growth-positive
/PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today...
BrainStorm Cell Therapeutics Inc. announced the rescheduling of its financial results release for Q1 2025 and an investor conference call. The company is a leader in developing autologous adult stem cell therapies for neurodegenerative diseases, with its lead therapy, NurOwn, targeting ALS. NurOwn has received Orphan Drug designation from the FDA and EMA, and a Phase 3 trial has been completed. A confirmatory Phase 3b trial is planned under a Special Protocol Assessment with the FDA. BrainStorm is also advancing an exosome-based platform and has received a Notice of Allowance for a patent covering this technology. The companys developments indicate a positive growth trajectory.
Product StageInvestment
growth-positive
BrainStorm Cell Therapeutics to Announce First Quarter Results and Provide a Corporate Update on May 15, 2025
BrainStorm Cell Therapeutics Inc., a leader in adult stem cell therapies for neurodegenerative diseases, announced a conference call to update shareholders on its financial results for Q1 2025 and provide a corporate update. The company is advancing its NurOwn® platform, which has received Orphan Drug designation from the FDA and EMA for ALS. A Phase 3 trial has been completed, and a confirmatory Phase 3b trial is set to launch under an SPA agreement with the FDA. BrainStorm is also developing an exosome-based platform and recently received a Notice of Allowance for a foundational patent, strengthening its IP portfolio.
Product StageFDA approved/pending approval
growth-positive
BrainStorm to Present Biomarker Insights Supporting NurOwn's Mechanism of Action and Clinical Impact at the 2025 ALS Drug Development Summit
BrainStorm Cell Therapeutics Inc. is participating in the 4th Annual ALS Drug Development Summit to discuss advancements in ALS research. The company will present findings on cerebrospinal fluid biomarkers related to their investigational cell therapy, NurOwn, and its potential multimodal mechanism of action. The insights from their Phase 3 study are being used to refine biomarkers for an upcoming Phase 3b trial under an SPA agreement with the FDA. The summit will also cover adaptive and decentralized clinical trial models to improve ALS trial design and accessibility. Discussions will emphasize patient and caregiver engagement in shaping clinical trial protocols and improving access to investigational therapies.
Product Stage
growth-positive
BrainStorm's NurOwn® Data Selected as Breakthrough Science for Presentation at ISCT 2025 Meeting
BrainStorm Cell Therapeutics Inc. announced new pharmacogenomic data on NurOwn®, highlighting the impact of the UNC13A genotype on ALS treatment response. The data will be presented at the ISCT 2025 Annual Meeting. The company is preparing to launch a Phase 3b trial of NurOwn, with positive communication from the FDA and an IND amendment submitted. The study aims to build on existing clinical data and explore genetic factors influencing treatment response, moving towards personalized medicine for ALS. The findings are part of ongoing efforts to address unmet needs in neurodegenerative diseases.
Product StageFDA approved/pending approval
growth-positive
BrainStorm Cell Therapeutics Submits IND Amendment to FDA, Paving the Way for Phase 3b Trial of NurOwn® in ALS
BrainStorm Cell Therapeutics Inc. has submitted an Investigational New Drug (IND) amendment to the FDA for its NurOwn® therapy, aimed at treating amyotrophic lateral sclerosis (ALS). This amendment is a significant step towards initiating a Phase 3b clinical trial, designed in collaboration with the FDA under a Special Protocol Assessment (SPA). The trial will enroll approximately 200 ALS patients and will assess the efficacy of NurOwn in slowing disease progression. The successful completion of this trial could lead to a Biologics License Application (BLA) submission, accelerating the path to potential approval. The company is optimistic about a swift regulatory review and is committed to working closely with regulatory agencies and the ALS community.
Product Stage
growth-negative
Brainstorm Cell Therapeutics Inc (BCLI) Q4 2024 Earnings Call Highlights: Navigating Financial ...
Brainstorm Cell Therapeutics Inc is facing significant financial challenges as it seeks to advance its NurOwn technology through a Phase 3b clinical trial. The company has secured a special protocol assessment with the FDA, reducing regulatory risks, and is negotiating clinical trial agreements with 15 leading centers in the U.S. Despite these advancements, Brainstorm is constrained by limited cash reserves, approximately $0.4 million as of December 2024, and anticipates needing $20 million to $30 million annually to complete the trial. To manage financial pressure, the company has implemented salary reductions and unpaid work periods for staff. Partnerships with IQVIA and Pluri Inc. aim to support trial execution and manufacturing. The company is exploring funding options, including licensing non-core assets and non-dilutive financing.
Product StagePartnersInvestment
growth-positive
Q4 2024 Brainstorm Cell Therapeutics Inc Earnings Call
Brainstorm Cell Therapeutics Inc is advancing its investigational treatment for ALS, NurOwn, into a critical Phase 3b trial. The company is focused on regulatory, clinical, and manufacturing aspects to ensure trial success. They have secured a special protocol assessment with the FDA, de-risking the regulatory pathway. Brainstorm has partnered with IQVIA for trial execution and Pluri Inc. for manufacturing. Financially, the company is pursuing multiple funding avenues, including licensing non-core assets and exploring non-dilutive financing options. Despite financial constraints, the team is committed to proving NurOwns potential, with many employees working under reduced compensation. The company aims to raise $20-30 million annually to complete the trial.
Product StagePartnersInvestment
growth-positive
BrainStorm Cell Therapeutics Announces Full Year 2024 Financial Results and Provides Corporate Update
BrainStorm Cell Therapeutics Inc. announced its financial results for the fiscal year ending December 31, 2024, and provided a corporate update. The company is focused on developing and commercializing therapies for neurodegenerative diseases, particularly ALS, through its product NurOwn. BrainStorm is preparing for a Phase 3b trial of NurOwn, having secured a Special Protocol Assessment with the FDA, which derisks the regulatory aspects of the program. A strategic partnership with Pluri has been established to support manufacturing for the trial. The company also regained compliance with Nasdaqs minimum bid price requirement. These developments indicate a positive growth trajectory for BrainStorm.
Product StagePartners
growth-positive
BrainStorm Cell Therapeutics Granted Compliance Extension from Nasdaq
BrainStorm Cell Therapeutics Inc. has been granted an extension by the Nasdaq Hearings Panel until June 30, 2025, to regain compliance with listing standards. The company is committed to executing its compliance plan, which includes launching a Phase 3b ALS study for its NurOwn® technology, reducing debt, and pursuing strategic partnerships. BrainStorm is focused on enhancing shareholder value and advancing its clinical programs. The company holds exclusive worldwide licensing rights for NurOwn®, which has received Orphan Drug designation from the FDA and EMA for ALS. BrainStorm is planning a confirmatory Phase 3b trial in ALS and has completed a Phase 3 trial assessing NurOwn in ALS.
Product StagePartners
growth-positive
/PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced...
BrainStorm Cell Therapeutics Inc., a leader in developing stem cell therapies for neurodegenerative diseases, announced a conference call scheduled for March 31, 2025, to update shareholders on its financial results for the fourth quarter and year ended December 31, 2024. The company is planning a confirmatory Phase 3b trial for its NurOwn technology in ALS, which has received Orphan Drug designation from the FDA and EMA. BrainStorms exosome technology offers innovative therapeutic solutions for neurodegenerative and respiratory diseases. The company has completed a Phase 3 trial for NurOwn in ALS and advanced clinical studies in multiple sclerosis, supported by grants from CIRM and NMSS. The announcement is growth-positive, highlighting ongoing clinical advancements and regulatory achievements.
Product StageFDA approved/pending approval
growth-positive
BrainStorm to Announce Fourth Quarter and Fiscal Year 2024 Financial Results and Provide a Corporate Update
BrainStorm Cell Therapeutics Inc., a leader in stem cell therapeutics for neurodegenerative diseases, announced a conference call scheduled for March 31, 2025, to update shareholders on its financial results for the fourth quarter and year ended December 31, 2024. The call will feature key executives, including the CEO, COO, CMO, and interim CFO. BrainStorm is planning a confirmatory Phase 3b trial for its NurOwn technology in ALS, which has received Orphan Drug designation from the FDA and EMA. The company has completed a Phase 3 trial for ALS and advanced studies in MS, supported by grants from CIRM and NMSS. BrainStorms exosome technology offers customizable solutions for targeted delivery of bioactive molecules in neurodegenerative and respiratory diseases.
Product StageFDA approved/pending approval
growth-positive
BCLI: Plans Coming Together for Phase 3b Trial of NurOwn® in ALS…
BrainStorm Cell Therapeutics, Inc. is preparing for a Phase 3b clinical trial of NurOwn in ALS patients, with plans to initiate in Q1 2025. The company achieved significant milestones in 2024, including an FDA Special Protocol Assessment and alignment on Chemistry, Manufacturing, and Controls. A Memorandum of Understanding with Pluri Inc. was signed for GMP-compliant manufacturing of NurOwn. Positive survival data from the Expanded Access Program was presented, showing a statistically significant survival benefit for debamestrocel-treated patients. The company is seeking non-dilutive financing to fund the trial.
Product StagePartners
growth-positive
BrainStorm Issues 2024 Letter to Shareholders
BrainStorm Cell Therapeutics Inc. has made significant progress in 2024, achieving a Special Protocol Assessment (SPA) with the FDA for its Phase 3b clinical trial of NurOwn, a treatment for neurodegenerative diseases. This SPA agreement de-risks the regulatory pathway for NurOwn, enhancing its potential for approval. The company has also aligned with the FDA on its Chemistry, Manufacturing, and Controls (CMC) plan, ensuring a consistent manufacturing process. BrainStorm has partnered with Pluri Inc. for clinical manufacturing, leveraging Pluris expertise to support the trial. Research indicates that NurOwn may reduce neurofilament light levels, a biomarker of neurodegeneration, suggesting potential benefits for ALS patients. These developments underscore BrainStorms commitment to advancing its therapeutic offerings.
Partners
growth-positive
BrainStorm Cell Therapeutics to Host Investor Call and Provide a Corporate Update
BrainStorm Cell Therapeutics Inc., a leader in adult stem cell therapeutics for neurodegenerative diseases, announced a conference call and webcast scheduled for December 30, 2024. The event will feature updates from key executives, including President and CEO Chaim Lebovits. A Q&A session with the investment community will follow the prepared remarks. Additionally, BrainStorm will host a Key Opinion Leader Webinar on ALS advancements on December 11, 2024, featuring Dr. Terry Heiman Patterson from Temple University. These events aim to engage the investment community and highlight the companys progress in ALS treatment.
growth-positive
/PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced...
BrainStorm Cell Therapeutics Inc. announced that it has received a Notice of Allowance from the U.S. Patent & Trademark Office for its proprietary exosome technology. This patent, which covers the composition and method of BrainStorms unique exosomes derived from MSC-NTF cells, strengthens the companys intellectual property portfolio. The patent is expected to provide protection until April 10, 2039. BrainStorm is focused on developing NurOwn for ALS and is preparing for a Phase 3b registrational trial. The company is also exploring strategic collaborations for its exosome platform, which has significant therapeutic potential in respiratory and neurodegenerative diseases. The announcement is seen as a positive development for BrainStorm, reinforcing its position as a leader in cellular and exosome-based therapies.
growth-positive
BrainStorm Strengthens Exosome Patent Portfolio: Receives Notice of Allowance for U.S. Patent Covering Its Platform Technology
BrainStorm Cell Therapeutics Inc. has received a Notice of Allowance from the U.S. Patent & Trademark Office for its patent application covering proprietary exosome technology. This patent, which is expected to provide protection until April 10, 2039, strengthens BrainStorms intellectual property portfolio and enhances its position in developing cellular and exosome-based therapies. The exosomes, derived from MSC-NTF cells, have significant therapeutic potential in respiratory and neurodegenerative diseases. BrainStorm is focused on developing NurOwn for ALS and is exploring strategic collaborations for its exosome platform.
growth-positive
BrainStorm Cell Therapeutics to Host KOL Webinar on Current Developments in the Treatment of Amyotrophic Lateral Sclerosis (ALS) on December 11, 2024
BrainStorm Cell Therapeutics Inc., a leader in adult stem cell therapeutics for neurodegenerative diseases, is hosting a key opinion leader (KOL) webinar on December 11, 2024. The webinar will feature Dr. Terry Heiman-Patterson from Temple University, who will discuss ALS treatment advancements. BrainStorms management will provide updates on their planned Phase 3b clinical trial for NurOwn®, a treatment for ALS, and future development plans. The successful completion of the trials randomized portion is expected to support a Biologic License Application for NurOwn. Dr. Heiman-Patterson is a renowned figure in ALS research, with extensive experience and numerous contributions to the field.
growth-positive
BrainStorm Cell Therapeutics Announces Third Quarter 2024 Financial Results and Provides Corporate Update
BrainStorm Cell Therapeutics Inc. announced its financial results for Q3 2024 and provided updates on its upcoming Phase 3b trial of NurOwn for ALS. The company has partnered with Pluri Inc. to manufacture NurOwn, with a Memorandum of Understanding in place to transfer manufacturing technology. The trial will involve approximately 200 participants and aims to demonstrate the treatments efficacy. The trials success could lead to a Biologic License Application. BrainStorm remains committed to advancing NurOwn as a therapeutic option for ALS patients.
Partners
growth-positive
BrainStorm Cell Therapeutics and Pluri Partner to Support NurOwn® Phase 3b Trial Manufacturing
BrainStorm Cell Therapeutics Inc. has signed a Memorandum of Understanding (MOU) with Pluri Inc. to manufacture NurOwn® for its planned Phase 3b trial in amyotrophic lateral sclerosis (ALS). This collaboration will enable BrainStorm to transfer its manufacturing technology to Pluris facility in Israel, ensuring GMP-compliant production of NurOwn®. The partnership aims to meet the clinical supply requirements for the trial and explore options for future commercial distribution, pending regulatory approval. This strategic move strengthens BrainStorms operational capabilities and aligns with its priorities for the upcoming trial. The collaboration with Pluri is expected to enhance communication and productivity between the two companies.
Partners
growth-positive
BrainStorm Cell Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement
BrainStorm Cell Therapeutics Inc. announced that it has regained compliance with the Nasdaq Stock Markets minimum closing bid price requirement, ensuring its continued listing on the Nasdaq Capital Market. This development is significant for the company, which specializes in developing cellular therapies for neurodegenerative diseases. BrainStorm holds exclusive rights to the NurOwn technology platform, which has been designated as an Orphan Drug by the FDA and EMA for treating ALS. The company has completed a Phase 3 trial for ALS and a Phase 2 trial for progressive MS, supported by grants from various organizations. This positive compliance news is expected to bolster investor confidence and support the companys ongoing clinical and commercial endeavors.
Public Trading
growth-positive
BrainStorm Cell Therapeutics Presented Positive Survival Data from NurOwn® Expanded Access Program at 2024 Annual NEALS Meeting
BrainStorm Cell Therapeutics Inc. presented two posters at the 2024 Annual NEALS Meeting, highlighting the potential benefits of their treatment, NurOwn, for ALS patients. The posters detailed the results from an Expanded Access Program (EAP) and outlined plans for a Phase 3b trial. The EAP involved ten participants, showing improved survival rates and stabilization of neurodegeneration markers for those treated with NurOwn. The findings suggest that longer-term treatment with NurOwn could be beneficial for ALS patients, marking a positive development for BrainStorms therapeutic approach.
growth-positive
BrainStorm Cell Therapeutics to Provide Corporate Update on Phase 3b NurOwn® Trial at the 2024 Maxim Healthcare Virtual Summit
BrainStorm Cell Therapeutics Inc. announced its participation in the 2024 Maxim Healthcare Virtual Summit, where CEO Chaim Lebovits will discuss the upcoming Phase 3b clinical trial for NurOwn, a cell therapy for ALS. The summit, scheduled for October 15-17, will feature discussions on healthcare trends. BrainStorms NurOwn technology, which targets neurodegenerative diseases, has shown promise in ALS treatment through various clinical studies. The company holds exclusive rights to develop and commercialize this technology, which has received Orphan Drug designation from the FDA and EMA. The announcement highlights BrainStorms commitment to ALS research and its engagement with the investment community.
Investment
growth-positive
BrainStorm Cell Therapeutics Announces Presentations on NurOwn® at 2024 Annual NEALS Meeting
BrainStorm Cell Therapeutics Inc. announced the acceptance of two abstracts featuring their NurOwn® technology at the 2024 Annual Northeastern Amyotrophic Lateral Sclerosis Consortium (NEALS) Meeting. The company is focused on advancing their Phase 3b clinical trial to confirm the efficacy of NurOwn in early-stage ALS patients. The NurOwn platform, which has shown promise in targeting neurodegenerative diseases, has received significant support from various grants. BrainStorm aims to achieve regulatory approval and bring their novel treatment to ALS patients as quickly as possible.
CustomersInvestment
growth-positive
Life Sciences Virtual Investor Forum Agenda Announced for September 19th
Virtual Investor Conferences (VIC) announced the agenda for the Life Sciences Virtual Investor Forum, scheduled for September 19, 2024. Co-sponsored by Zacks Small-Cap Research, the event aims to bring together individual and institutional investors, advisors, and analysts. The forum will facilitate real-time investor engagement, allowing companies to present directly to investors, schedule one-on-one meetings, and enhance presentations with dynamic video content. Jason Paltrowitz, EVP of Corporate Services at OTC Markets Group, emphasized the efficiency and engagement benefits of the conference.
Partners
growth-positive
BCLI: SPA in Place for Phase 3b Trial of NurOwn® in ALS…
BrainStorm Cell Therapeutics, Inc. is preparing for a Phase 3b clinical trial of NurOwn in patients with amyotrophic lateral sclerosis (ALS), expected to initiate in Q4 2024 or Q1 2025. The company has made progress in trial preparation, including receiving written agreement from the FDA on the design of the trial and resolving all previous outstanding Chemistry, Manufacturing, and Controls (CMC) issues. BrainStorm is also pursuing various nondilutive funding opportunities, including a grant application with the potential to secure up to $15 million. The company reported no revenues for Q2 2024, with net R&D expenses of $0.9 million and G&A expenses of $2.1 million.
InvestmentExpand
growth-positive
BrainStorm Cell Therapeutics Announces Second Quarter 2024 Financial Results and Provides Corporate Update
BrainStorm Cell Therapeutics Inc. has announced its financial results for Q2 2024, revealing a net loss of $2.5 million, compared to a net loss of $5.3 million in Q2 2023. The company also raised $4.0 million in a registered direct offering with a single institutional investor. BrainStorm has made progress in its preparations for the planned Phase 3b trial of NurOwn in ALS, having secured agreement with the FDA on a Special Protocol Assessment and reached alignment on the CMC aspects. The company also appointed Hartoun Hartounian Ph.D. as EVP and COO, and promoted Dr. Bob Dagher to EVP and CMO.
InvestmentManagement Changes
Growth-Positive
BrainStorm Cell Therapeutics to Announce Second Quarter Results and Provide a Corporate Update
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, has announced a conference call to update shareholders on financial results for the second quarter ended June 30, 2024, and provide a corporate update. The companys CEO, Chaim Lebovits, will present a corporate update, and other members of the management team will answer investment community questions. BrainStorm Cell Therapeutics is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases.
Management Changes
Growth-Positive
BCLI Update - Progress Supports Our 10x Plus Value Range Potential
BrainStorm Cell Therapeutics Inc. is developing NurOwn® stem cell therapy for Neurodegenerative diseases, with its first target being ALS. The company has resolved FDA questions, put a commercialization team in place, raised US$ 4m for PIIIb rollout, signed a CRO, and lined up a commercial manufacturer. This has shortened the Biologics Licence Application timeline. Despite the dilution effect of the new warrants, the companys value range remains well above the >10x return investment hypothesis. The company is also exploring non-dilutive grant funds.
InvestmentExpand
growth-positive
BCLI: Preparing to Initiate Phase 3b Trial of NurOwn™ Before End of 2024…
BrainStorm Cell Therapeutics is preparing for a Phase 3b clinical trial of NurOwn in patients with amyotrophic lateral sclerosis (ALS), with the trial expected to begin before the end of 2024. The company has made significant progress in trial preparation, including receiving agreement from the FDA on the design of the trial and resolving all previous outstanding CMC issues. In June 2024, BrainStorm appointed Hartoun Hartounian, PhD as its new Executive Vice President and Chief Operating Officer. The company also announced a $4.0 million registered direct offering through the sale of approximately 11.1 million shares of common stock.
InvestmentManagement Changes
BrainStorm Cell Therapeutics to Provide Corporate Mid-Year Update on NurOwn Program
BrainStorm Cell Therapeutics Announces Pricing of $4.0 Million Registered Direct Offering
growth-positive
BrainStorm Cell Therapeutics Reaches Alignment with FDA on CMC Aspects of Phase 3b NurOwn® Clinical Trial
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, has announced alignment with the U.S. Food and Drug Administration (FDA) on the Chemistry, Manufacturing, and Controls (CMC) aspects of its Phase 3b clinical trial for NurOwn, its investigational therapy for amyotrophic lateral sclerosis (ALS). This follows the FDA granting BrainStorm a Special Protocol Assessment (SPA) agreement for its NurOwn Phase 3b trial in April 2024. The company is now preparing for the pivotal Phase 3b trial of NurOwn.
Partners
growth-positive
BrainStorm Cell Therapeutics Announces Appointment of Haro Hartounian Ph.D. as Chief Operating Officer
BrainStorm Cell Therapeutics Inc. has appointed Hartoun Hartounian Ph.D. as its new EVP and COO, effective as of June 24, 2024. Dr. Hartounian has over 32 years of experience in the biopharmaceutical industry, with a focus on cell and gene therapy. He will oversee all operational aspects of BrainStorm Cell Therapeutics, including CMC and commercialization. His appointment is expected to enhance the companys operational efficiency and support the commercial readiness of its therapeutic platforms.
Management Changes
growth-positive
BCLI: Initiation - Potential 10x Return on Successful Phase 3b. Promising Post Hoc and Biomarker Analysis Underpins Our NurOwn® Clinical Effectiveness Expectation
BrainStorm Cell Therapeutics Inc. is developing autologous mesenchymal stem cell therapies for neurodegenerative diseases, with a primary focus on amyotrophic lateral sclerosis (ALS). Analysis of the companys Phase III trial data shows significant clinical effects on early-stage ALS patients. The FDA has agreed to a binding commitment for a Phase IIIb ALS trial of the companys NurOwn treatment. BrainStorm has also regained NASDAQ compliance. The companys valuation only includes the smaller US market, excluding the larger EU/UK market.
Investment
growth-positive
BrainStorm Cell Therapeutics to Present New Biomarker Data Suggesting ALS Patients May Benefit From Longer-Term Treatment with NurOwn
BrainStorm Cell Therapeutics Inc. will present new biomarker data at the 3rd Annual ALS Drug Development Summit, suggesting that ALS patients may benefit from longer-term treatment with debamestrocel (NurOwn). The data shows a consistent reduction of neurofilament light (NfL) from baseline among participants who were randomized to receive NurOwn in the Phase 3 study. The company hopes to confirm these results in the planned Phase 3b trial of NurOwn. The summit will take place from May 21 to 23, 2024 in Boston MA.
CustomersPartners
growth-positive
BrainStorm Cell Therapeutics Announces First Quarter 2024 Financial Results and Provides Corporate Update
BrainStorm Cell Therapeutics Inc. has announced its financial results for Q1 2024 and provided a corporate update. The company received written agreement from the U.S. FDA under a Special Protocol Assessment (SPA) on the design for a Phase 3b trial of NurOwn. BrainStorm also promoted Dr. Bob Dagher to Executive Vice President and Chief Medical Officer, while Dr. Stacy Lindborg stepped down from the role of Co-CEO. The companys cash, cash equivalents, and restricted cash amounted to approximately $1.0 million as of March 31, 2024. The net loss for the first quarter ended March 31, 2024 was $3.4 million.
Management Changes
growth-positive
BrainStorm Cell Therapeutics Announces Management Changes as Company Plans Registrational Phase 3b Trial of NurOwn
BrainStorm Cell Therapeutics Inc. has announced the promotion of Dr. Bob Dagher to Executive Vice President and Chief Medical Officer. Dr. Stacy Lindborg is stepping down from her role as Co-CEO and will transition to the companys Board of Directors. These changes come as the company prepares to embark on a Phase 3b trial for NurOwn, its investigational cell therapy treatment for amyotrophic lateral sclerosis (ALS). Dr. Dagher has served as Chief Development Officer since July 2023 and will now oversee the planned Phase 3b trial.
Management Changes
Growth-Positive
BrainStorm Cell Therapeutics Regains Compliance with NASDAQ Minimum Market Value Rule
BrainStorm Cell Therapeutics Inc., a developer of cellular therapies for neurodegenerative diseases, has regained compliance with the Nasdaqs minimum market value of listed securities requirement. The company received a notification letter from the Nasdaq on April 10, 2024, confirming that it had maintained a market value of listed securities of $35,000,000 or greater for 11 consecutive business days. BrainStorm holds the rights to the NurOwn® technology platform, which has received Orphan Drug designation status from the FDA and the EMA for the treatment of ALS.
Public Trading
growth-positive
BCLI: Receives SPA Agreement from FDA on Design of Phase 3b Trial of NurOwn™…
BrainStorm Cell Therapeutics, Inc. has received a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) for a Phase 3b trial of NurOwn™ in amyotrophic lateral sclerosis (ALS). The trial will be a two-part, multicenter study enrolling ALS patients who are earlier in the course of their disease. The company also announced the publication of Phase 3 biomarker data in Muscle and Nerve, suggesting that NurOwn treatment may impact key biomarkers in ALS patients that are predictive of disease progression. BrainStorm announced financial results for 2023, with net R&D expenses for 2023 at $10.8 million compared to $14.0 million in 2022.
Investment
growth-positive
BrainStorm Cell Therapeutics Announces Peer-reviewed Publication of Biomarker Data from NurOwn's® Phase 3 Clinical Trial in ALS
BrainStorm Cell Therapeutics Inc. has announced the publication of Phase 3 biomarker data in Muscle and Nerve, which suggests that their investigational cell therapy, NurOwn, may impact key biomarkers in amyotrophic lateral sclerosis (ALS) that are predictive of disease progression. The study analyzed forty-five biomarkers and identified three that are predictive of clinical outcomes in debamestrocel-treated participants. The company is planning for a Phase 3b trial to confirm these findings.
InvestmentExpand
growth-positive
BrainStorm Cell Therapeutics Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS
BrainStorm Cell Therapeutics Inc. has announced that it has received written agreement from the U.S. Food and Drug Administration (FDA) on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS). The Special Protocol Assessment (SPA) agreement validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn. The company anticipates commencement of the Phase 3b study in 2024. The trial will assess the efficacy and safety of NurOwn in patients with ALS.
Partners
Growth-Positive
BrainStorm Cell Therapeutics to Provide Update on NurOwn Program
BrainStorm Cell Therapeutics Inc., a leading developer of cellular therapies for neurodegenerative diseases, will hold a conference call to update shareholders on the NurOwn® program. The companys President and Chief Executive Officer, Chaim Lebovits, Co-Chief Executive Officer, Stacy Lindborg, PhD and Chief Development Officer, Bob Dagher, MD, will present the update. The company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells. The cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS).
InvestmentManagement Changes
growth-negative
BrainStorm Cell Therapeutics Announces Full Year 2023 Financial Results and Provides Corporate Update
BrainStorm Cell Therapeutics Inc. announced its financial results for the year ended December 31, 2023, and provided a corporate update. The companys priority for 2024 is to move forward with a confirmatory Phase 3b trial for NurOwn, a treatment for neurodegenerative diseases. In October 2023, BrainStorm withdrew its Biological License Application for NurOwn in ALS and announced a strategic realignment to accelerate the development of NurOwn, which included a reduction in headcount by approximately 30 percent. The companys net loss for the year ended December 31, 2023, was $17.2 million.
LayoffsInvestment
growth-positive
BCLI: Unveils Plans for Phase 3b Trial of NurOwn® in ALS…
On March 4, 2024, BrainStorm Cell Therapeutics, Inc. presented a poster outlining the proposed design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS). The design is currently under review by the FDA. The company also submitted a Special Protocol Assessment (SPA) to the FDA regarding the design of the Phase 3b trial. The SPA program will allow BrainStorm to reach a consensus with the FDA on the trial design and ensure that the study is considered adequate by the FDA to support a future marketing evaluation. A response from the FDA is expected within 45 days of submission.
Investment
growth-positive
BrainStorm Cell Therapeutics to Unveil Phase 3b NurOwn® Trial Design at MDA Clinical and Scientific Conference
BrainStorm Cell Therapeutics Inc. has announced plans for a Phase 3b trial of NurOwn, a treatment for amyotrophic lateral sclerosis (ALS). The trial design will be presented at the MDA Clinical and Scientific Conference. The trial will assess the efficacy and safety of NurOwn in ALS patients. The company has submitted a Special Protocol Assessment request to the FDA for the trial. The trial is designed to generate robust data to support a future marketing application. The company is committed to making NurOwn available to ALS patients.
Investment
growth-positive
BrainStorm Cell Therapeutics Submits Special Protocol Assessment (SPA) Request to FDA for Phase 3b Trial of NurOwn® in ALS
BrainStorm Cell Therapeutics Inc. has submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA) for a Phase 3b study of NurOwn, its investigational treatment for amyotrophic lateral sclerosis (ALS). The submission follows a meeting with the FDA in December 2023. The SPA would allow BrainStorm to reach consensus with the FDA on its clinical trial design, ensuring the study would be considered adequate to support a future marketing evaluation. The response is expected within 45 days of submission.
Partners
growth-positive
BrainStorm Cell Therapeutics to Present at European Life Sciences CEO Forum
BrainStorm Cell Therapeutics Inc., a developer of adult stem cell therapeutics for neurodegenerative diseases, announced that it will provide a corporate update at the 17th Annual European Life Sciences CEO Forum in Zurich, Switzerland. Co-CEO Dr. Stacy Lindborg will participate in a panel discussion, and both Lindborg and CEO Chaim Lebovits will be available for in-person and virtual meetings. BrainStorm holds the rights to the NurOwn technology platform, which has received Orphan Drug designation status from the FDA and EMA for the treatment of ALS.
Management Changes
growth-positive
BrainStorm Granted Patents for Allogeneic Exosome Platform-Product in Neurological Disorder Treatments
Brainstorm Cell Therapeutics Inc. has been granted three patent applications for its NurOwn and NurOwn-Exosomes technologies by the European, Australian, and Israeli patent offices. The patents cover methods of qualifying whether a cell population is suitable for treating ALS, and the use of isolated exosomes derived from MSC-NTF cells for treating neurodegenerative diseases. The companys CEO, Chaim Lebovits, stated that the acquisition of these patents is a crucial step in protecting their proprietary technology and expanding its reach through new global partnerships.
AcquisitionExpand
growth-positive
BrainStorm Issues 2023 Letter to Shareholders
BrainStorm Cell Therapeutics Inc. has issued a letter to shareholders, outlining its commitment to advancing NurOwn, a treatment for ALS patients. Despite setbacks with the ADCOMs unfavorable vote, the company is pursuing a Phase 3b trial and is seeking a Special Protocol Assessment (SPA) to de-risk the regulatory aspects of the NurOwn program. The company is exploring various strategies to secure the necessary funding and is committed to maintaining its NASDAQ listing status. The company anticipates making a submission for the SPA in February 2024.
Investment
growth-positive
BCLI: FDA Meeting Provides Clear Path for Planned Phase 3b Trial of NurOwn
On December 7, 2023, BrainStorm Cell Therapeutics, Inc. announced that it had a productive meeting with the U.S. Food and Drug Administration (FDA) regarding the planned Phase 3b trial for NurOwn, a treatment for amyotrophic lateral sclerosis (ALS). The company is set to submit a Special Protocol Assessment (SPA), a process that could support marketing approval. The FDA provided constructive feedback on the trial design and is working cooperatively with BrainStorm to expedite the SPA process. The companys management believes that it is on a fast track to acquiring the SPA.
CustomersPartners
growth-positive
BrainStorm Cell Therapeutics Announces Outcome of FDA Meeting on NurOwn® in ALS
BrainStorm Cell Therapeutics Inc. has completed a productive meeting with the U.S. Food and Drug Administration (FDA) to discuss NurOwn, its investigational treatment for amyotrophic lateral sclerosis (ALS). The meetings primary objective was to discuss key considerations for a Special Protocol Assessment (SPA) for a planned Phase 3b registrational trial for NurOwn. BrainStorm will submit relevant documentation as outlined by the FDA to support the SPA. The ultimate goal is to secure the FDAs agreement that critical elements of the overall protocol design are adequate and acceptable for a study intended to support a future marketing application.
Partners
growth-positive
BrainStorm Cell Therapeutics Announces In-Person Meeting with the FDA to Discuss Confirmatory Phase 3 Trial for NurOwn® in ALS
BrainStorm Cell Therapeutics Inc. has announced that the US Food & Drug Administration (FDA) has granted the company a meeting to discuss the regulatory path forward for NurOwn® in amyotrophic lateral sclerosis (ALS). The meeting is scheduled for December 6, 2023. Brainstorm will discuss plans for a Special Protocol Assessment (SPA) with the FDA to agree on the overall protocol design for a confirmatory Phase 3 trial in ALS. The companys proposed plan is to conduct a confirmatory Phase 3b trial.
Partners
growth-positive
BrainStorm Cell Therapeutics to Present at 6th Annual ALS Research Symposia
BrainStorm Cell Therapeutics Inc. announced a presentation and panel discussion at the 6th Annual ALS Research Symposium hosted by ALS ONE. The presentation will feature new analyses from the NurOwn placebo-controlled Phase 3 amyotrophic lateral sclerosis (ALS) trial that highlight the biological effect of NurOwn through CSF biomarker data. The Phase 3 NurOwn trial was a multi-center, placebo-controlled, randomized, double-blind trial designed to evaluate the safety and efficacy of repeat doses of NurOwn in 189 ALS participants. The NurOwn clinical program has generated valuable insights into the pathology of ALS, as well as disease progression and treatment.
Investment
Growth-Negative
BCLI: Phase 3b Trial Details to be Discussed with FDA…
On October 18, 2023, BrainStorm Cell Therapeutics announced that the FDA has invited the company to discuss the development plan for NurOwn, a treatment for amyotrophic lateral sclerosis (ALS). The company also withdrew the Biologics License Application for NurOwn following a negative outcome at an Advisory Committee meeting. The company remains committed to advancing NurOwn as a therapy for ALS and plans to conduct a Phase 3b trial. On November 14, 2023, BrainStorm announced its Q3 2023 financial results, reporting no revenues and a decrease in expenses. The company is exploring options to raise capital for the Phase 3b trial and has undertaken a targeted reduction in headcount to cut costs.
InvestmentManagement Changes
growth-negative
Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) Q3 2023 Earnings Call Transcript
Brainstorm Cell Therapeutics Inc. reported its Q3 2023 financial results and ongoing progress. The company has withdrawn its BLA for NurOwn from FDA review following the outcome of the Advisory Committee. The company plans to conduct a meeting with the FDA to discuss next steps, including the design for a confirmatory Phase 3b study in ALS. The company is also exploring various options to raise capital, including non-dilutive grants, and capitalizing on certain non-core assets. As part of a strategic realignment, the company has reduced its headcount by approximately 30% and estimates that this will cut total resource consumption by approximately 50%.
InvestmentLayoffs
growth-negative
Q3 2023 Brainstorm Cell Therapeutics Inc Earnings Call
Brainstorm Cell Therapeutics Inc. held its Q3 2023 earnings call, discussing financial results and future plans. The company announced that it had withdrawn the Biologics License Application (BLA) for its NurOwn technology from FDA review following an advisory committee review. The company plans to conduct a meeting with the FDA to discuss next steps, including a confirmatory Phase 3b study in ALS. As part of its regulatory strategy, the company intends to seek a Special Protocol Assessment with the FDA before continuing with the planned registration trial. The company also announced a strategic realignment to conserve resources, including a reduction in headcount of approximately 30%.
InvestmentLayoffs
growth-negative
BrainStorm Cell Therapeutics Announces Third quarter 2023 Financial Results and Provides Corporate Update
BrainStorm Cell Therapeutics Inc. has announced its Q3 2023 financial results and provided a corporate update. The company is committed to making NurOwn, a treatment for ALS, available and is working with the FDA to agree on a path forward. However, Brainstorm withdrew its Biological License Application for NurOwn in October 2023 following an FDA committee meeting. The company also announced a strategic realignment to accelerate the development of NurOwn, which includes a targeted reduction in headcount of approximately 30 percent. In July 2023, Brainstorm raised approximately $7.5 million in a registered direct offering with a single institutional investor.
InvestmentLayoffs
Neutral
BrainStorm to Announce Third Quarter 2023 Financial Results and Provide a Corporate Update
BrainStorm Cell Therapeutics Inc. announced that it will hold a conference call on November 14th to discuss its financial results for the third quarter ended September 30, 2023, and provide a corporate update. The companys President and CEO, Chaim Lebovits, and Co-CEO, Stacy Lindborg, will provide the update, while Interim CFO Alla Patlis will discuss the financials. The company is a leading developer of cellular therapies for neurodegenerative diseases.
Investment
growth-negative
BrainStorm Cell Therapeutics Announces Strategic Realignment Prioritizing NurOwn® for the Treatment of ALS
BrainStorm Cell Therapeutics Inc. has announced a strategic realignment to accelerate the development of NurOwn for the treatment of amyotrophic lateral sclerosis (ALS). The company plans to conduct a Phase 3b U.S. clinical trial for NurOwn in ALS and is exploring various options to raise capital for the study. As part of the realignment, BrainStorm will reduce resource consumption by approximately half and undertake a targeted reduction in headcount of approximately 30 percent. Dr. Kirk Taylor, EVP and Chief Medical Officer, will be stepping down from his post.
Management ChangesLayoffsInvestment
Growth-Negative
BCLI: Meeting with FDA to Discuss Development Plan for NurOwn®…
On October 18, 2023, BrainStorm Cell Therapeutics announced that the U.S. Food and Drug Administration (FDA) has invited the company to request an expedited meeting to discuss the path forward for NurOwn® as a treatment for amyotrophic lateral sclerosis (ALS). The company also announced that it is withdrawing the Biologics License Application (BLA) for NurOwn. This decision follows the negative outcome of the Advisory Committee meeting last month. BrainStorm remains committed to advancing NurOwn as a therapy for ALS, with a registrational Phase 3b trial necessary in order to seek regulatory approval.
Management Changes
growth-negative
BrainStorm Cell Therapeutics to Meet with US FDA to Discuss Development Plan for NurOwn as a Treatment of ALS
BrainStorm Cell Therapeutics Inc. has announced that it will withdraw its Biologics License Application (BLA) for NurOwn, a treatment for amyotrophic lateral sclerosis (ALS). The decision was made in coordination with the FDA and is seen as a withdrawal without prejudice. The company has been invited by the FDA to request an expedited meeting to discuss the future of NurOwn. Despite the withdrawal, BrainStorm remains committed to the ALS community and is exploring next steps, including the publication of emerging clinical data and the development of a protocol for an additional clinical study.
Management Changes
Growth-Negative
BrainStorm, after setbacks, withdraws approval application for ALS drug
BrainStorm Cell Therapeutics has announced plans to withdraw an approval application for its experimental ALS treatment, NurOwn, following significant pushback from the FDA. The FDA had expressed concerns over the safety and effectiveness of NurOwn, as well as BrainStorms data analysis and conclusions. The company now plans to conduct a Phase 3b clinical trial and is developing a protocol for an additional study. The decision comes less than a month after the FDA convened an outside group of advisers to evaluate NurOwn. The companys share price dropped 5% following the announcement.
Management Changes
growth-negative
BCLI: Advisory Panel Votes Against Recommending Approval of NurOwn®…
On September 27, 2023, the U.S. Food and Drug Administration (FDA) convened a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee to review the Biologics License Application for BrainStorm Cell Therapeutics, Inc.s NurOwn. The Committee voted 17-1 that NurOwn did not demonstrate substantial evidence of effectiveness for the treatment of mild to moderate amyotrophic lateral sclerosis (ALS). The FDA will still need to render a decision about whether or not to approve NurOwn on or before the PDUFA date of December 8, 2023, however, the approval is not anticipated.
CustomersInvestment
growth-negative
BrainStorm Cell Therapeutics Provides Update on FDA Advisory Committee Meeting to Review NurOwn for the Treatment of ALS
BrainStorm Cell Therapeutics Inc. announced the outcome of the U.S. Food and Drug Administrations Cellular, Tissue and Gene Therapies Advisory Committee meeting to review the Biologics License Application (BLA) for NurOwn, a stem cell therapy for the treatment of amyotrophic lateral sclerosis (ALS). The Committee voted that NurOwn did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS. Despite this setback, BrainStorm remains committed to exploring all options available to continue their research and fulfill their obligation to the ALS community.
Customers
Growth-Positive
BrainStorm Cell Therapeutics Stock Trading Halted Today
BrainStorm Cell Therapeutics Inc. has announced that Nasdaq has halted trading of the companys common stock as the U.S. Food and Drug Administrations (FDA) Cellular, Tissue and Gene Therapies Advisory Committee is meeting to review BrainStorms Biologics License Application (BLA) for NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS). The Prescription Drug User Fee Act (PDUFA) action date for NurOwn® is targeted to occur by December 8, 2023. NurOwn® is a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders.
InvestmentPublic Trading
Growth-Negative
FDA advisers vote against experimental ALS treatment pushed by patients
The US FDA panel has voted against Brainstorm Cell Therapeutics experimental treatment for Lou Gehrig’s disease, also known as ALS. The panel voted 17-1 that the stem cell-based treatment has not been shown effective for patients with the fatal, muscle-wasting disease. The FDA is not bound by the vote, but it aligns with the agency’s own negative review released earlier this week. Brainstorm’s single 200-patient study failed to show that the treatment extended life, slowed disease or improved patient mobility. The FDA is expected to issue a decision on the therapy by Dec. 8.
InvestmentPublic Trading
growth-positive
BCLI: Public Support for NurOwn® from Prominent ALS Specialists…
BrainStorm Cell Therapeutics (NASDAQ:BCLI) has received over 1,700 comments on the FDA docket for the NurOwn AdCom, many of which are positive. These comments come from prominent ALS physicians and scientists who have seen the positive effects of NurOwn in clinical trials. The FDA will convene a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (AdCom) to review the Biologics License Application (BLA) for NurOwn® on September 27, 2023. Despite the FDAs initial skepticism, BrainStorms management will have the opportunity to present their case for NurOwns approval. The company continues to assert that the totality of the evidence shows that NurOwn has a consistent and clinically meaningful treatment effect across a broad range of patients with ALS.
Customers
Growth-Positive
Brainstorm Cell Therapeutics Inc.'s (NASDAQ:BCLI) Path To Profitability
Brainstorm Cell Therapeutics Inc., a biotechnology company, is expected to reach breakeven in about two years, according to industry analysts. The company, which develops and commercializes autologous cellular therapies for neurodegenerative diseases, has been reducing its losses, with the latest trailing-twelve-month loss at US$22m, down from a US$24m loss in the previous full financial year. Analysts expect the company to post a final loss in 2024, before turning a profit of US$54m in 2025. They also expect the company to grow 56% year-on-year, on average.
Investment
growth-positive
BCLI: Preparing for AdCom on September 27, 2023…
BrainStorm Cell Therapeutics is preparing for an Advisory Committee Meeting on September 27, 2023, where the FDA will review the Biologics License Application for NurOwn. The company is also preparing for the commercial launch of NurOwn, if approved. BrainStorm has been working with consultants to prepare a persuasive presentation for the FDA. The company also announced new biomarker data from the Phase 3 trial of NurOwn. Financially, the company reported no revenues for Q2 2023 and net R&D expenses of $2.8 million. The company also entered into a securities purchase agreement with an institutional investor for the sale of over 4 million shares, raising approximately $7.5 million.
Investment
growth-positive
Q2 2023 Brainstorm Cell Therapeutics Inc Earnings Call
Brainstorm Cell Therapeutics Inc. held its second-quarter 2023 earnings call, during which it discussed its financial results and recent progress. The company is preparing for the forthcoming advisory committee for NurOwn, its investigational therapy for the treatment of ALS, and is working to ensure the company is prepared to make NurOwn available to patients. The FDA will review the companys BLA for NurOwn on September 27, with a PDUFA action date of December 8, 2023. The company also discussed its plans for a confirmatory trial and its ongoing research into the safety and clinical effectiveness of NurOwn.
Management ChangesInvestment
growth-positive
BrainStorm Cell Therapeutics Announces Second Quarter 2023 Financial Results and Provides Corporate Update
BrainStorm Cell Therapeutics Inc. has announced its financial results for Q2 2023 and provided a corporate update. The company is preparing for an FDA advisory committee meeting to discuss NurOwn for Amyotrophic Lateral Sclerosis (ALS) scheduled for September 27, 2023. The companys Biologics License Application (BLA) for NurOwn has a Prescription Drug User Fee Act (PDUFA) action date targeted to occur by December 8, 2023. The company has also made several management changes and raised approximately $7.5 million in a registered direct offering.
InvestmentManagement ChangesExpand
Neutral
BrainStorm to Announce Second Quarter 2023 Financial Results and Provide a Corporate Update
BrainStorm Cell Therapeutics Inc., a leading developer of cellular therapies for neurodegenerative diseases, will hold a conference call to update shareholders on financial results for the second quarter ended June 30, 2023, and provide a corporate update. The companys President and CEO, Chaim Lebovits, and Co-CEO, Stacy Lindborg, will provide the update and answer questions from the investment community. The company is known for its innovative autologous adult stem cell therapeutics and holds the rights to the NurOwn® technology platform used to produce autologous MSC-NTF cells.
Investment
Growth-Positive
Brainstorm Cell Therapeutics Announces Pricing of $7.5 Million Registered Direct Offering
BrainStorm Cell Therapeutics Inc. has announced a securities purchase agreement with a single institutional investor for the purchase and sale of over 4 million shares of the companys common stock and warrants. The offering is expected to close on or about July 19, 2023, subject to customary closing conditions. Maxim Group LLC is acting as the sole placement agent for the offering. The gross proceeds from the offering, before deducting the placement agents fees and other offering expenses, are expected to be approximately $7.5 million.
Investment
growth-positive
BrainStorm Cell Therapeutics Appoints Bob Dagher, M.D., as Executive Vice President and Chief Development Officer
BrainStorm Cell Therapeutics Inc. has announced the appointment of Bob Dagher, MD, as Executive Vice President and Chief Development Officer, effective July 17, 2023. Dr. Dagher will be responsible for the portfolio strategy and advancement of clinical development plans towards regulatory approval, including the expansion of NurOwn into new diseases. Dr. Dagher joins BrainStorm from Enveric Biosciences where he was Chief Medical Officer. His appointment comes at a pivotal time for BrainStorm, as their lead investigational platform, NurOwn, is currently under review by the U.S. Food and Drug Administration for the treatment of amyotrophic lateral sclerosis (ALS).
Management ChangesExpand
growth-positive
BrainStorm Cell Therapeutics Appoints Nir Naor as Board Member and Audit Committee Chair
BrainStorm Cell Therapeutics Inc. has announced the appointment of Nir Naor as a Board Member, chairman of its Audit Committee, and member of its Governance, Nomination and Compensation Committee, effective June 20. Naor is replacing Malcolm Taub, who is retiring after 14 years of service on the companys board of directors. Naor brings over 20 years of global work experience as CFO and senior finance leader, with the majority of his career spent at U.S. and European corporations.
Management Changes
growth-positive
BrainStorm Cell Therapeutics to Participate in the Maxim Group Healthcare Virtual Conference
BrainStorm Cell Therapeutics Inc., a developer of adult stem cell therapeutics for neurodegenerative diseases, announced that its Co-CEO, Dr. Stacy Lindborg, and CEO, Chaim Lebovits, will participate in a fireside chat at the Maxim Group Healthcare Virtual Conference on June 21, 2023. The conference will be hosted by M-Vest. BrainStorm holds the rights to the clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells, which have received Orphan Drug designation status from the FDA and EMA for the treatment of ALS.
Management Changes
Growth-Positive
BrainStorm Cell Therapeutics Announces FDA Advisory Committee Meeting to Review NurOwn® Biologics License Application Scheduled for September 27, 2023
BrainStorm Cell Therapeutics Inc. has announced that the U.S. Food and Drug Administration (FDA) will convene a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee (ADCOM) to review the Biologics License Application (BLA) for NurOwn, its investigational mesenchymal stem cell therapy for the treatment of amyotrophic lateral sclerosis (ALS). The meeting is scheduled for September 27, 2023, and the Prescription Drug User Fee Act (PDUFA) action date is targeted to occur by December 8, 2023. BrainStorms management expressed confidence in NurOwn and its potential for regulatory approval.
InvestmentExpand
growth-positive
BCLI: Awaiting Adcom Date for NurOwn®…
BrainStorm Cell Therapeutics, Inc. has been granted an Advisory Committee (AdCom) meeting by the U.S. Food and Drug Administration (FDA) to discuss the company’s Biologics License Application (BLA) for NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS). The company has also announced the appointment of Dr. Kirk Taylor as Executive Vice President and Chief Medical Officer. The company reported no revenues for the first quarter of 2023, with net R&D expenses of $2.9 million. The company had approximately $2.2 million in cash, cash equivalents, and short-term deposits as of the end of the first quarter.
Management ChangesCustomers
growth-positive
BrainStorm Cell Therapeutics Summarizes Key Messages from Its Participation as Expert Speakers in an Invited Presentation and Panel Discussion at The 2023 ALS Drug Development Summit
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, participated in the 2023 ALS Drug Development Summit. Co-CEO Stacy Lindborg and Vice President Antonio Trejo Diaz were invited expert speakers at the summit. Lindborg presented a talk on the challenges and limitations of the ALSFRS-R endpoint in its current state. Trejo Diaz participated in a panel reviewing the progress made in ALS drug development. BrainStorm also announced that it has been granted an FDA Advisory Committee Meeting to discuss its Biologics License Application for NurOwn.
InvestmentPartnersManagement Changes
Growth-Positive
While institutions own 23% of Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI), retail investors are its largest shareholders with 59% ownership
Brainstorm Cell Therapeutics Inc. is majorly owned by retail investors, who hold 59% of the companys shares. Institutions account for 23% of the companys stockholders, while insiders own 12%. The largest shareholder is Kevin Ness, who owns 9.5% of the shares, followed by the second and third largest shareholders who hold about 5.9% and 5.3% of the stock respectively. The CEO, Chaim Lebovits, owns 0.7% of the shares. The top 25 shareholders collectively control less than half of the companys shares, indicating that the shares are widely disseminated and there is no dominant shareholder.
Investment
growth-positive
Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) Q1 2023 Earnings Call Transcript
Brainstorm Cell Therapeutics Inc. held its Q1 2023 earnings call, reporting better than expected earnings. The company also discussed its NurOwn technology platform, which is being developed for the treatment of neurodegenerative diseases such as ALS. The company is confident in the data supporting regulatory approval of NurOwn and is preparing for an advisory committee to discuss their BLA. Brainstorm is also expanding its team, with recent hires including Dr. Kirk Taylor as Executive Vice President and Chief Medical Officer, Antonio Trejo as VP Regulatory Affairs, and Robin Wallace as Vice President Global Clinical Operations.
Management ChangesExpand
growth-positive
BrainStorm Cell Therapeutics Announces First Quarter 2023 Financial Results and Provides Corporate Update
BrainStorm Cell Therapeutics Inc. has announced its Q1 2023 financial results and provided a corporate update. The company is preparing for an FDA Advisory Committee Meeting for the Biologics License Application for NurOwn, a treatment for ALS. The company has recently added Dr. Kirk Taylor as EVP, Chief Medical Officer, and Antonio Trejo and Robin Wallace as VPs of Regulatory Affairs and Clinical Operations respectively. The company has also announced a partnership with the Northeast Amyotrophic Lateral Sclerosis (NEALS) Consortium, The ALS Association and I AM ALS.
Management ChangesExpand
Growth-Positive
BrainStorm to Announce First Quarter 2023 Financial Results and Provide a Corporate Update
BrainStorm Cell Therapeutics Inc., a developer of cellular therapies for neurodegenerative diseases, has announced a conference call to update shareholders on its financial results for Q1 2023 and provide a corporate update. The call will be held at 8:00 a.m. Eastern Time on Monday, May 15th, 2023. BrainStorms President and CEO, Chaim Lebovits, and Co-CEO, Stacy Lindborg, PhD, will provide the update and answer questions from the investment community.
Investment
growth-positive
BrainStorm Cell Therapeutics Strengthens Leadership Team with Appointment of Kirk Taylor, M.D., as Executive Vice President and Chief Medical Officer
BrainStorm Cell Therapeutics Inc. has announced the appointment of Kirk Taylor, M.D., as Executive Vice President and Chief Medical Officer (EVP, CMO), effective May 1, 2023. Dr. Taylor will lead the global medical affairs function and launch activities, including product launches, post-approval commercialization efforts and deepening relationships with the medical community. The appointment is part of BrainStorms targeted capability build to prepare for anticipated growth. The company is preparing for regulatory review of its Biologics License Application (BLA) for NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS).
Management ChangesExpand
growth-positive
Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) Is Expected To Breakeven In The Near Future
Brainstorm Cell Therapeutics Inc., a biotech company specializing in autologous cellular therapies for neurodegenerative diseases, is expected to reach breakeven in about two years, according to industry analysts. Despite posting a loss of $24m for its most recent financial year, the company is projected to turn a profit of $54m in 2025, with an average annual growth rate of 50%. However, the company currently has negative equity on its balance sheet due to accounting methods used to deal with accumulated losses.
Investment
growth-positive
Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI) Q4 2022 Earnings Call Transcript
Brainstorm Cell Therapeutics Inc. held its Q4 2022 earnings call on March 30, 2023. The company reported several clinical and operational achievements in 2022 and plans to advance its NurOwn technology through the regulatory process in 2023. The FDA intends to hold an advisory committee meeting to discuss Brainstorms Biologics License Application (BLA) for NurOwn as a treatment for ALS. The company also reported its financial results for 2022, with cash, cash equivalents, and short-term bank deposits of approximately $3 million as of December 31, 2022.
Management ChangesInvestment
growth-positive
BCLI: Preparing for Adcom for NurOwn®…
BrainStorm Cell Therapeutics, Inc. has been granted an Advisory Committee (AdCom) meeting by the U.S. Food and Drug Administration (FDA) to discuss the company’s Biologics License Application (BLA) for NurOwn, a treatment for amyotrophic lateral sclerosis (ALS). This follows a Type A meeting with the FDA in early January 2023 to discuss the refusal to file letter (RTF) that the company received in November 2022. BrainStorm has filed an amendment to the BLA that responds to most of the outstanding questions the FDA had posed. The company also presented post hoc sensitivity analyses from NurOwn’s Phase 3 ALS trial at the MDA Meeting in March 2023. On March 30, 2023, BrainStorm announced financial results for 2022, reporting no revenues and net R&D expenses of $14.0 million.
InvestmentManagement Changes
growth-positive
BrainStorm Cell Therapeutics Announces Full Year 2022 Financial Results and Provides a Corporate Update
BrainStorm Cell Therapeutics Inc. has announced its financial results for the fiscal year ended December 31, 2022, and provided a corporate update. The companys priority in 2023 is to advance NurOwn through the regulatory process as quickly as possible. The U.S. Food and Drug Administration (FDA) has notified BrainStorm that it will hold an Advisory Committee Meeting to review the companys Biologics License Application for NurOwn for the treatment of amyotrophic lateral sclerosis (ALS). The company has also announced a partnership with the Northeast Amyotrophic Lateral Sclerosis (NEALS) Consortium, The ALS Association and I AM ALS.
PartnersInvestment
growth-positive
BrainStorm Cell Therapeutics Announces FDA Advisory Committee Meeting to Review Biologics License Application for NurOwn® for the Treatment of ALS
BrainStorm Cell Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) will hold an Advisory Committee Meeting to discuss the companys Biologics License Application for NurOwn, a treatment for amyotrophic lateral sclerosis (ALS). The company has chosen the File Over Protest pathway, which offers the fastest path to an ADCOM and regulatory decision. The ALS community has been waiting for this ADCOM for years, and the meeting will provide an open forum for BrainStorm and the FDA to review all available evidence supporting NurOwn. The company remains confident in NurOwn and is committed to making the product available quickly to people living with ALS.
CustomersInvestment
growth-positive
BCLI: FDA Grants Adcom for NurOwn®…
BrainStorm Cell Therapeutics, Inc. has been granted an Advisory Committee meeting by the U.S. Food and Drug Administration (FDA) to discuss the companys Biologics License Application for NurOwn, a treatment for amyotrophic lateral sclerosis (ALS). This follows the companys Type A meeting with the FDA in early January 2023 to discuss the refusal to file letter that the company received in November 2022. The company has filed an amendment to the BLA that responds to most of the outstanding questions the FDA had posed. The company is now working towards winning the support of the Advisory Committee.
Investment
Neutral
BrainStorm to Announce Fourth Quarter and Fiscal Year 2022 Financial Results and Provide a Corporate Update
BrainStorm Cell Therapeutics Inc., a developer of cellular therapies for neurodegenerative diseases, announced a conference call to update shareholders on financial results for Q4 and the year ended December 31, 2022. The call will also provide a corporate update. The companys President and CEO, Chaim Lebovits, and Co-CEO, Stacy Lindborg, will present the update. The investment community will have the opportunity to ask questions. The call is scheduled for 8:00 a.m. Eastern Time on Thursday, March 30th.
Investment
growth-positive
BrainStorm Cell Therapeutics Partners with NEALS, The ALS Association, and I AM ALS to Provide Public Access to Biospecimens from NurOwn's Phase 3 ALS Study
BrainStorm Cell Therapeutics Inc. has announced that it will donate biospecimens from its Phase 3 ALS trial of NurOwn to the Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) biorepository. The donation is supported by a $500,000 grant previously awarded to BrainStorm by The ALS Association and I AM ALS. The specimens, which include serum and cerebrospinal fluid samples, will be used for biomarker research. BrainStorms CEO thanked the ALS Association and I AM ALS for their funding, and NEALS for housing the samples for future use by the research community.
PartnersInvestment
growth-positive
BrainStorm Cell Therapeutics to Present at Biotech Showcase™ 2023
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced that its President and CEO, Chaim Lebovits, and Co-CEO, Stacy Lindborg, will present a corporate and clinical overview at the Biotech Showcase 2023. The company management will also be available for one-on-one investor meetings at the conference. BrainStorm Cell Therapeutics is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases.
Management Changes
growth-positive
BrainStorm Cell Therapeutics Announces Promotion of Dr. Stacy Lindborg to Co-Chief Executive Officer
BrainStorm Cell Therapeutics Inc. has promoted Dr. Stacy Lindborg to the role of Co-Chief Executive Officer. Dr. Lindborg, who joined BrainStorm in 2020, brings over 25 years of pharmaceutical industry experience in R&D, strategy development, regulatory, and analytics. This promotion is part of a broader strategic initiative to build out the leadership team and position BrainStorm for success. Dr. Ralph Kern will retire from his current role as President and Chief Medical Officer in January 2023 and will continue to support BrainStorm as part of the companys Scientific Advisory Board.
Management ChangesExpand
growth-positive
BrainStorm Cell Therapeutics Announces Type A Meeting with FDA Granted for NurOwn®
BrainStorm Cell Therapeutics Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted a Type A meeting to discuss the contents of a refusal to file letter previously issued regarding the companys New Biologics License Application (BLA) for NurOwn® for the treatment of ALS. The meeting is scheduled for January 11, 2023. The company believes that an Advisory Committee Meeting would serve as an important part of the review process and would provide an open forum for BrainStorm, together with medical experts, statisticians, patients and other members of the ALS community to discuss the body of clinical evidence supporting NurOwn.
CustomersPartners
growth-positive
BrainStorm Cell Therapeutics Submits Type A Meeting Request to U.S. Food and Drug Administration
BrainStorm Cell Therapeutics Inc. has submitted a Type A Meeting Request to the U.S. Food and Drug Administration (FDA) to discuss the contents of a refusal to file letter previously issued by the FDA regarding the companys New Biologics License Application (BLA) for NurOwn® for the treatment of ALS. The company aims to address the issues raised in the refusal letter and secure an Advisory Committee Meeting. BrainStorm has completed a Phase 3 trial for NurOwn in approximately 200 participants with ALS.
CustomersPartners
growth-positive
BrainStorm Cell Therapeutics Presents NurOwn® Phase 2 Progressive MS Biomarker Data at the 38th ECTRIMS Congress
BrainStorm Cell Therapeutics Inc. has announced that a scientific abstract on the effects of its NurOwn treatment on cerebrospinal fluid neuroprotective biomarkers will be presented at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis. The phase 2 clinical trial demonstrated that NurOwn treatment resulted in significant increases in these biomarkers. The NurOwn technology platform is a promising therapeutic approach to neurodegenerative disorders, and BrainStorm holds the rights to its clinical development and commercialization.
Investment
growth-positive
BrainStorm Presents New Biomarker Analyses from NurOwn's Phase 3 ALS Trial at the ALS ONE Research Symposium
BrainStorm Cell Therapeutics Inc. has presented new biomarker analyses supporting the therapeutic benefit of NurOwn in amyotrophic lateral sclerosis (ALS) at the 5th Annual ALS ONE Research Symposium. The analyses provide further evidence of NurOwns multifaceted mechanism of action and show consistent patterns in study participants regardless of the level of disease progression at baseline. The Phase 3 NurOwn trial was a multi-center, placebo-controlled, randomized, double-blind trial designed to evaluate the safety and efficacy of repeat doses of NurOwn in 189 ALS participants.
Investment
growth-positive
BrainStorm Brings MS Data on Heels of ALS BLA Announcement (Updated) | BioSpace
BrainStorm Cell Therapeutics has published peer-reviewed data from a Phase II trial of NurOwn in progressive multiple sclerosis (MS), showing preliminary evidence of efficacy. The therapy was proven safe in the small study, which consisted of 20 participants with progressive MS. The study compared these 20 patients to 48 matched controls from the Comprehensive Longitudinal Investigation of Multiple Sclerosis (CLIMB) registry of Brigham and Womens Hospital and the Ann Romney Center for Neurologic Diseases. All comparison metrics fell strongly in NurOwn’s favor as the study met all endpoints. The data was published in the Multiple Sclerosis Journal.
Investment
growth-positive
BrainStorm Cell Therapeutics Announces Peer Reviewed Publication of Results from the NurOwn® Phase 2 Progressive MS Trial in Multiple Sclerosis Journal
BrainStorm Cell Therapeutics Inc. has announced the publication of data from the Phase 2 trial of NurOwn in progressive multiple sclerosis (MS) in Multiple Sclerosis Journal. The study demonstrated NurOwns safety and provided preliminary evidence of its efficacy in people with progressive MS. The trial enrolled 20 participants, with 17 receiving all three scheduled NurOwn treatments. The results showed large, clinically meaningful improvements in some patients across all endpoints measured. The companys CEO, Chaim Lebovits, stated that the publication is an important step in the evaluation of NurOwn in progressive MS.
InvestmentExpand
growth-positive
BrainStorm Cell Therapeutics Announces Second Quarter 2022 Financial Results and Provides a Corporate Update
BrainStorm Cell Therapeutics Inc. has announced its decision to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for NurOwn, a treatment for amyotrophic lateral sclerosis (ALS). The company also reported financial results for Q2 2022, with a net loss of approximately $7.0 million. The company has strengthened its executive team in preparation for anticipated growth and corporate development. The companys cash, cash equivalents, and short-term bank deposits were approximately $12.2 million as of June 30, 2022.
InvestmentManagement Changes
growth-positive
BrainStorm Announces Presentation of NurOwn® Exosome Preclinical Data at ISCT 2022 San Francisco Meeting
BrainStorm Cell Therapeutics Inc. has presented a poster at the International Society of Cell & Gene Therapy ISCT 2022 Meeting, detailing the superior anti-inflammatory effects of its NurOwn-derived exosomes compared to naïve mesenchymal stem cell-derived exosomes. The data provides insights into the mechanism of action of Exo MSC-NTF, which has shown preclinical efficacy in acute lung injury models. The companys Chief Medical Officer, Ralph Kern, stated that the findings suggest the efficacy is due to the anti-inflammatory effects of Exo MSC-NTF on macrophage populations. The company is committed to exploring the full potential of its proprietary cell technology platform.
Investment
growth-positive
Brainstorm Cell Therapeutics Announces Grant of a New Brazilian Patent Covering Methods of Manufacturing NurOwn®
Brainstorm Cell Therapeutics Inc. has announced that the Brazilian Patent Office has granted a patent application for a method of generating cells which secrete various neurotrophic factors, a process used in the manufacturing of MSC-NTF cells (NurOwn). The company is committed to the development of NurOwn as a potential treatment for ALS and other neurodegenerative diseases. The patent enhances the companys ability to establish commercial preparedness worldwide and to enter into new commercial partnerships for NurOwn in South America and worldwide.
Partners
growth-positive
BrainStorm Cell Therapeutics Announces peer reviewed publication of NurOwn's® Phase 3 Study for ALS in Muscle and Nerve
BrainStorm Cell Therapeutics Inc. has announced the publication of Phase 3 clinical data for its cellular therapy for neurodegenerative diseases, NurOwn. The data, published in Muscle and Nerve, come from a randomized, double-blind, placebo-controlled, Phase 3 trial evaluating the safety and efficacy of NurOwn. Although the trial did not reach statistical significance on the primary or secondary endpoints, analyses show a NurOwn-induced treatment effect in those with less advanced disease. BrainStorm CEO Chaim Lebovits said the data provide evidence of NurOwns effectiveness in driving meaningful clinical benefit for ALS patients with less advanced disease.
Investment
growth-negative
Stem cell therapy for ALS fails a large clinical trial
Brainstorm Cell Therapeutics experimental treatment for ALS failed to meet the main goal of a late-stage clinical trial, causing a significant drop in the companys share price. The study recruited patients with rapidly progressing ALS and gave them either a placebo or Brainstorms therapy. While the therapy appeared to have a positive effect, it didnt significantly outperform the placebo. Despite the setback, Brainstorm executives are confident theres a path forward for its therapy.
Investment
growth-positive
BrainStorm Announces Financial Results for the Third Quarter of 2020 and Provides a Corporate Update BioSpace
BrainStorm Cell Therapeutics Inc., a leading developer of cellular therapies for neurodegenerative diseases, announced its financial results for Q3 2020. The company is awaiting top-line data readout for the NurOwn Phase 3 trial in ALS, expected by the end of November. A successful outcome will set the company on the path to filing a Biologic License Application (BLA) for what it believes will be a valuable new treatment for ALS. The company has also made changes to its management team, adding William K. White and Dr. Anthony Waclawski.
Management ChangesInvestment
growth-positive
Brainstorm Announces Grant of a New Japanese Patent for NurOwn®
Brainstorm Cell Therapeutics Inc. has been granted a Japanese patent for its method of generating cells which secrete neurotrophic factors from human undifferentiated mesenchymal stem cells (MSCs). The patent is a significant addition to the companys intellectual property portfolio for its NurOwn technology. The companys CEO, Chaim Lebovits, expressed satisfaction with the development, noting that it is a crucial aspect of their business strategy. The patent will also enhance the companys ability to form new commercial partnerships for NurOwn in Japan.
Investment
growth-positive
BrainStorm Announces Publication of New Preclinical Data Supporting Proposed NurOwn® Mechanism in ALS, Progressive MS and Alzheimer's Disease
BrainStorm Cell Therapeutics Inc. has published a manuscript detailing the effects of its NurOwn (MSC-NTF cells) on T and B regulatory cell function in Amyotrophic Lateral Sclerosis (ALS). The company has demonstrated that a single administration of NurOwn increased circulating T regulatory cells and reduced cerebrospinal fluid inflammatory biomarkers. The company is currently conducting a phase 3 clinical trial in ALS and a phase 2 trial in progressive multiple sclerosis.
Investment
growth-positive
BrainStorm Announces Completion of All Dosing in NurOwn® Phase 3 Clinical Trial in ALS
BrainStorm Cell Therapeutics Inc. has announced the final participant dosing in the Phase 3 pivotal trial of NurOwn, a stem cell therapy for neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS). The trial enrolled around 200 participants, with results expected in Q4 2020. The trial was conducted at six centers of excellence, including the University of California, Irvine, and the Mayo Clinic. The company also recently received acceptance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) and initiated enrollment in March 2019.
CustomersPartners
growth-positive
BrainStorm Granted SME Status by the European Medicines Agency
BrainStorm Cell Therapeutics Inc., a developer of adult stem cell therapies for neurodegenerative diseases, has been granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency’s (EMA) Micro, Small and Medium-Sized Enterprise (SME) office. This status allows BrainStorm to participate in significant financial incentives including a 90% to 100% EMA fee reduction for scientific advice, clinical study protocol design, and quality inspections of facilities. The companys ALS investigational product received orphan drug status in Europe in July 2013.
InvestmentExpand
growth-positive
The ALS Association, I AM ALS Award BrainStorm Cell Therapeutics $500,000 for ALS Biomarker Study BioSpace
The ALS Association and I AM ALS have awarded a combined grant of $500,000 to BrainStorm Cell Therapeutics to support a research study on amyotrophic lateral sclerosis (ALS) biomarkers. The grant will be used to draw insights from data and samples collected from patients enrolled in BrainStorms ongoing phase 3 clinical trial of its NurOwn treatment. The study aims to evaluate how NurOwn interacts with its targets in the brain and spinal cord and to explore the changes in the biomarkers that may correlate with response to the drug treatment.
InvestmentPartners
growth-positive
BrainStorm Announces that Pivotal Phase 3 Trial Remains on Track for Topline Data in Q4-2020
BrainStorm Cell Therapeutics Inc. has announced an update on its Phase 3 pivotal trial investigating NurOwn in ALS. Despite the COVID-19 pandemic, the company expects that top-line data from the trial will be announced by Q4-2020. The clinical trial sites are at University of California, Irvine; Cedars-Sinai Medical Center; California Pacific Medical Center; Massachusetts General Hospital; University of Massachusetts Medical School and Mayo Clinic. The companys CEO, Chaim Lebovits, stated that the company made the decision to continue the Phase 3 trial and has been strongly supported by its partners in the clinical community.
CustomersPartners
https://www.prnewswire.com/il/news-releases/brainstorm-appoints-pharmaceutical-veteran-stacy-r-lindborg-phd-as-executive-vice-president-head-of-global-clini
growth-positive
BrainStorm Leases a New Cleanroom Facility at The Tel Aviv Sourasky Medical Center to Manufacture NurOwn® for The European Union
BrainStorm Cell Therapeutics Inc. has announced a lease agreement with the Tel Aviv Sourasky Medical Center to produce NurOwn in three state-of-the-art cleanrooms. The new facility will significantly increase the companys capacity to manufacture and ship its product into the European Union and the local Israeli market. The cleanroom facility is part of Souraskys Institute for Advanced Cellular Therapies. The agreement will ensure that BrainStorm can provide NurOwn to patients after regulatory approval, not only in Israel but also in the European Union.
PartnersExpand
growth-positive
BrainStorm Presents New Data Highlighting NurOwn® Immunomodulation in Neurology
BrainStorm Cell Therapeutics Inc. has announced new data highlighting the immunomodulatory effects of NurOwn on B and T regulatory function. The data was originally planned for presentation at the 2020 American Academy of Neurology (AAN) annual meeting, which was cancelled. The company is committed to fully developing NurOwn technology while continuing to expand understanding of potential biological mechanisms of action that may contribute to its therapeutic effects in neurodegenerative diseases. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases.
InvestmentExpand
growth-positive
BrainStorm Awarded $1.5 Million Non-Dilutive Grant for 2020 by the Israel Innovation Authority
BrainStorm Cell Therapeutics Inc. has been awarded a new grant of approximately $1.5 million by the Israel Innovation Authority (IIA). The grant will enable BrainStorm to continue development of advanced cellular manufacturing capabilities, further development of MSC-derived exosomes as a novel therapeutic platform, and expand the therapeutic pipeline in neurodegenerative disorders. The IIA has supported BrainStorm Cell Therapeutics Ltd. since 2007, providing grants totaling approximately 11.4 million USD in support of the development of NurOwn and other projects.
Investment
growth-positive
David Setboun Joins BrainStorm as Executive Vice President and Chief Operating Officer
BrainStorm Cell Therapeutics, a leading developer of cellular therapies for neurodegenerative diseases, has appointed David Setboun as Executive Vice President and Chief Operating Officer. Setboun has extensive experience in the pharmaceutical industry, having held senior roles at Life Biosciences, Biogen, AstraZeneca, and Eli Lilly. The company also announced the promotion of Ralph Kern to President. Kern has been with BrainStorm since March 2017, serving as Chief Operating Officer and Chief Medical Officer.
Management ChangesExpand
growth-positive
BrainStorm Appoints Renowned Distinguished Economist, Prof. Jacob Frenkel, Chairman of the Board of Directors
BrainStorm Cell Therapeutics Inc. has announced the appointment of Jacob Frenkel, Ph.D., as Chairman of the Board of Directors. Frenkel, a world-renowned economist and former Governor of the Bank of Israel, will join the Company at a crucial time as it completes its phase 3 ALS clinical trial and submits clinical trial data for regulatory review and publication later this year. Frenkel will support the Company’s global business development and partnership expansion. Sankesh Abbhi, a successful healthcare entrepreneur, executive and investor, also joins the Board.
Management ChangesExpand
growth-positive
BrainStorm Cell Therapeutics Raises $10.0 Million in Common Stock Sale at $8.00 Per Share
BrainStorm Cell Therapeutics Inc. has entered into a definitive agreement with Abbhi Investments, LLC for a privately negotiated sale of common stock and a warrant to purchase common stock. The sale will result in gross proceeds of $10.0 million for BrainStorm. The funds will be used to advance the companys clinical programs, commercial production of the investigational therapeutic NurOwn, regulatory, pre-marketing and commercialization preparation activities of NurOwn for ALS, working capital and general corporate purposes.
Investment
Growth-Positive
Fifth and Final Site Announced for BrainStorm's Progressive Multiple Sclerosis Phase 2 Clinical Trial
BrainStorm Cell Therapeutics Inc. has announced that Partners MS Center at Brigham and Women’s Hospital has contracted with BrainStorm as a clinical study site for the Company’s Phase 2 open-label, multicenter study of repeated intrathecal administration of NurOwn® (autologous MSC-NTF cells) in participants with progressive Multiple Sclerosis (MS). The study is expected to enroll participants soon under the supervision of Dr. Tanuja Chitnis and her team. The Partners MS Center at Brigham and Women’s Hospital joins other top US MS centers including Cleveland Clinic, Stanford University, School of Medicine, Mount Sinai Medical Center and University of Southern California for the study.
Partners
growth-positive
BrainStorm Cell Therapeutics and FDA Agree to Potential NurOwn® Regulatory Pathway for Approval in ALS
BrainStorm Cell Therapeutics, Inc. recently held a meeting with the U.S. Food and Drug Administration (FDA) to discuss potential regulatory pathways for approval of its NurOwn therapy in ALS. The FDA confirmed that the fully enrolled Phase 3 ALS trial is collecting relevant data critical to the assessment of NurOwn efficacy. The FDA and BrainStorm acknowledged the urgent need for ALS therapies and committed to work collaboratively to identify a regulatory pathway forward, including opportunities to expedite statistical review of data from the Phase 3 trial.
Partners
growth-positive
BrainStorm Receives Notice of Intention to Grant Additional EU patent for NurOwn®
BrainStorm Cell Therapeutics Inc. has announced that the European Patent Office (EPO) intends to grant a European patent for Methods of Generating Mesenchymal Stem Cells which secrete Neurotrophic Factors. This patent covers the industrial manufacturing process for NurOwn, a product developed by BrainStorms scientists. The addition of this EU patent to the companys existing patents in the United States, Canada, Israel, and Japan is expected to increase the companys ability to enter into new commercial partnerships for NurOwn in the EU and worldwide.
InvestmentPartners
Growth-Positive
NurOwn® Data Safety Monitoring Board Recommends MS Phase 2 Clinical Trial Continue
BrainStorm Cell Therapeutics, a leading developer of cellular therapies for neurodegenerative diseases, announced that the clinical trial independent Data Safety Monitoring Board (DSMB) has completed the first interim analysis of safety outcomes for 9 participants enrolled in the Phase 2 study of NurOwn in participants with progressive Multiple Sclerosis (MS). The DSMB unanimously concluded that the study should continue as planned without any protocol modification. BrainStorm is focused on completing the NurOwn progressive MS Phase 2 study and to bringing a much needed treatment option to MS patients.
InvestmentExpand
growth-positive
BrainStorm Issues 2019 Letter to Shareholders
BrainStorm Cell Therapeutics Inc. has issued a letter to shareholders detailing the companys progress in 2019. The company has completed full enrollment of a 200-patient Phase 3 clinical trial evaluating the use of NurOwn cellular therapeutic in treating amyotrophic lateral sclerosis (ALS). The company has also expanded its pipeline to include a new indication for NurOwn in progressive Multiple Sclerosis (MS). BrainStorm was awarded a grant of $495K from The National MS Society to support a Phase 2 biomarker study of NurOwn in progressive MS. The company has also expanded its intellectual patent portfolio and strengthened its executive team.
InvestmentManagement ChangesExpand
growth-positive
BrainStorm Selected as Buzz of BIO 2020 Winner
BrainStorm Cell Therapeutics Inc. has been selected as the Buzz of BIO in the Public Therapeutics Biotech category. The recognition also comes with an invitation to present at the BIO CEO & Investor Conference in New York City in February 2020. The Buzz of BIO contest identifies U.S. based companies with groundbreaking, early stage technologies that have the potential to improve lives. BrainStorm Cell Therapeutics is a leader in the development of innovative autologous cellular therapies for highly debilitating neurodegenerative diseases.
CustomersPartners
growth-positive
BrainStorm Cell Therapeutics Announces Research Grant Award From the National Multiple Sclerosis Society
BrainStorm Cell Therapeutics Inc. has received a $495,330 grant from the National Multiple Sclerosis Society to advance its Phase 2 clinical trial of NurOwn, a stem cell therapy for progressive Multiple Sclerosis. The funding will be used to explore key neuroinflammation and neural repair biomarkers in progressive MS to confirm NurOwn’s unique mechanism of action and guide the design of future clinical trials. The company is currently conducting the Phase 2 study in three leading US medical centers.
Investment
growth-positive
BrainStorm Announces Financial Results for the Third Quarter of 2019 and Provides a Corporate Update
BrainStorm Cell Therapeutics Inc. has announced its financial results for Q3 2019 and recent corporate updates. The company has fully enrolled 200 patients in the Phase 3 clinical trial of NurOwn in ALS (Amyotrophic Lateral Sclerosis). The company also announced that it received notification from the NurOwn Data Safety Monitoring Board that the study should continue without any changes in the protocol. The companys Phase 2 trial of NurOwn in Progressive MS (Multiple Sclerosis) continues to enroll patients. The company also appointed Preetam Shah, Ph.D., M.B.A. as Chief Financial Officer.
Management ChangesInvestment
growth-positive
BrainStorm Announces Grant of a New Japanese Patent for NurOwn®
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, has been granted a patent by the Japan Patent Office for its Method of Qualifying Cells. The patent covers cell populations that are therapeutic for the treatment of ALS and the method of qualifying the cells for therapeutic use. The companys President & CEO, Chaim Lebovits, stated that having a stem-cell product patented in Japan increases their ability to enter into new commercial partnerships for NurOwn in Japan.
InvestmentExpand
growth-positive
BrainStorm Announces Notice of US Patent Allowance for NurOwn® Cellular Therapeutic Technology Platform
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, has announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for BrainStorms new US Patent Application. The patent covers a pharmaceutical composition for MSC-NTF cells secreting neurotrophic factors (NurOwn®) comprising a culture medium as a carrier and an isolated population of differentiated bone marrow-derived MSCs that secrete neurotrophic factors. The company is currently conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS).
Investment
growth-positive
BrainStorm Cell Therapeutics Announces Support for FDA Guidelines on ALS Drug Development
BrainStorm Cell Therapeutics Inc. held a roundtable discussion with ALS advocacy group leaders in Washington, DC. The discussion was aimed at learning more about Brainstorm’s NurOwn phase 3 clinical development program in ALS and ensuring the patient voice was an ongoing, integral part of the discussion. The company supports the US FDA’s publication of “Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry.” The document outlines ALS drug development guidelines and potential opportunities to advance novel ALS therapies through innovative clinical trial design and validated clinical outcome measures.
PartnersExpand
growth-positive
FDA Accepts BrainStorm's NurOwn® IND Application for Progressive Multiple Sclerosis
BrainStorm Cell Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application to initiate a Phase 2 clinical trial of NurOwn for the treatment of progressive multiple sclerosis (MS). The trial is set to begin in the first quarter of 2019. There are currently no FDA approved autologous cellular therapies addressing MS or other neurological diseases. The company is also conducting a pivotal Phase 3 clinical trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS).
InvestmentExpand
growth-positive
BrainStorm Granted New U.S. Patent for Industrial Scale Manufacturing of NurOwn®
BrainStorm Cell Therapeutics Inc. has been granted a new US patent for its method of generating mesenchymal stem cells which secrete neurotrophic factors. The patent covers the industrial manufacturing process for NurOwn, a product developed by BrainStorms scientists. The company believes that having a US patented product will increase its ability to enter into new commercial partnerships for NurOwn in the US and worldwide.
Investment
growth-positive
BrainStorm Cell Therapeutics Announces Successful Interim Safety Analysis in Phase 3 Trial of NurOwn® Therapy for ALS
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapies for neurodegenerative diseases, announced that the independent Data Safety Monitoring Board (DSMB) has completed the pre-specified interim analysis of safety outcomes for the first 31 participants treated with NurOwn in the Phase 3 trial in ALS. The DSMB indicated there were no significant safety concerns and recommended that the trial continue, as planned. The study is expected to enroll 200 ALS participants, randomized 1:1 to NurOwn or placebo, and is evaluating the ALS functional rating scale (ALSFRS-R) as the primary efficacy outcome measure. The Company anticipates that 110 participants in total will be enrolled in the trial by January 2019.
Investment
growth-positive
BrainStorm Announces Grant of a New European Patent for NurOwn®
BrainStorm Cell Therapeutics Inc., a developer of adult stem cell therapeutics for neurodegenerative diseases, has been granted a European-wide patent for the treatment of Amyotrophic Lateral Sclerosis (ALS) with NurOwn. The patent, granted by the European Patent Office, provides protection for NurOwn in Europe until 2029. The patent covers methods of treating ALS using mesenchymal stem cells that secrete neurotrophic factors. The company believes that having a EU patented product will increase their ability to enter into new commercial partnerships for NurOwn in Europe.
CustomersPartners
growth-positive
BrainStorm Granted Japanese Patent for NurOwn®
BrainStorm Cell Therapeutics Inc. has received a Decision to Grant notice from the Japanese Patent Office for its patent titled Methods of generating mesenchymal stem cells which secrete neurotrophic factors. The patent provides protection for BrainStorms MSC-NTF cells (NurOwn) in Japan until 2033. The companys CEO, Chaim Lebovits, stated that the patent will increase their ability to enter into new commercial partnerships for NurOwn in Japan and they are expecting additional grants for this patent in other jurisdictions in the near future.
Partners
growth-positive
BrainStorm Cell Therapeutics to Present at ARM's 6th Annual Cell & Gene Therapy Investor Day, April 17 in New York
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell technologies for neurodegenerative diseases, announced that its CEO, Chaim Lebovits, will present at the Alliance for Regenerative Medicines (ARM) 6th Annual Cell & Gene Therapy Investor Day on April 17, 2018. In addition, two scientific posters describing ALSFRS-R subgroup analyses and innovative micro-RNA biomarker data from the NurOwn® Phase 2 randomized, double-blind, placebo-controlled study will be featured as podium presentations at the forthcoming American Academy of Neurology (AAN) Annual Meeting.
Investment
growth-positive
BrainStorm Cell Therapeutics' Phase 3 Trial of NurOwn® in ALS Now Open to Canadian Patients
BrainStorm Cell Therapeutics Inc. has amended the protocol of its Phase 3 clinical trial of NurOwn for the treatment of amyotrophic lateral sclerosis (ALS) to allow Canada-based ALS patients to enroll. The trial, which is designed to enroll 200 patients, is being conducted at six leading ALS clinical sites in the U.S. The amendment was approved by the FDA and Canada-based patients may now enroll in the study at the University of Massachusetts. Top-line data from the trial are expected in 2019.
CustomersExpand
growth-positive
Israeli ALS Treatment Developer Recruits Kite Pharma's CSO as Board Member
BrainStorm Cell Therapeutics has appointed Anthony Polverino, interim chief scientific officer at Kite Pharma, to its board of directors. BrainStorm, which is based in Petach Tikva, Israel, develops stem cell therapies for degenerative neurological conditions such as ALS, multiple sclerosis and Parkinsons disease. The company has raised around $37m in total equity funding, with the most recent investment being a $16m grant from The California Institute for Regenerative Medicine in July 2017. BrainStorm is currently in phase 3 clinical trials for its candidate NurOwn, a treatment for ALS.
Management Changes
growth-positive
BrainStorm Expands Its Patent Portfolio to Include a New US Patent For Its NurOwn® Technology for Parkinson's Disease And ALS
BrainStorm Cell Therapeutics Inc. has received a Notice of Allowance from the United States Patent Office for its patent application titled ISOLATED CELLS AND POPULATIONS COMPRISING SAME FOR THE TREATMENT OF CNS DISEASES. The patent covers methods of treating amyotrophic lateral sclerosis (ALS) and Parkinsons disease using mesenchymal stem cells that secrete neurotrophic factors. The patent is a result of Brainstorms ongoing development of NurOwn, a therapy that has been administered to approximately 70 patients with ALS in clinical trials conducted in the United States and Israel.
Investment
growth-positive
Stem cell co Brainstorm awarded $16m ALS grant
The California Institute for Regenerative Medicine (CIRM) has awarded a $16 million grant to Israeli stem cell developer Brainstorm Cell Therapeutics Inc. The grant will support a pivotal Phase III study of NurOwn, a treatment for amyotrophic lateral sclerosis (ALS). Brainstorm is in the advanced stages of planning the Phase III clinical trial, which is expected to enroll approximately 200 patients and will be conducted at six top ALS clinical sites in the US.
Investment
growth-positive
BrainStorm Awarded $2.1 Million Non-Dilutive Grant for 2017 by the Israel Innovation Authority
BrainStorm Cell Therapeutics Inc. has been awarded a $2.1 million grant by the Israel Innovation Authority (IIA) to support the development of NurOwn, its innovative mesenchymal stem cell-based platform for the treatment of neurodegenerative diseases. This is the tenth year that BrainStorm has received grant support from the IIA, with grants totaling approximately $7.5 million since 2007. The funds will be used to commence a Phase 3 pivotal trial with NurOwn.
Investment
growth-positive
Israeli Startup Reports Successful ALS Stem-Cell Therapy Trials
Israeli startup, BrainStorm Cell Therapeutics, has announced a successful trial of its therapy for Amyotrophic Lateral Sclerosis (ALS). The stem cell treatment, NurOwn, was administered in a mid-stage phase 2a trial in 14 patients with ALS at Hadassah Medical Center in Jerusalem. The company reported that nearly all subjects experienced clinical benefit from the treatment. The NurOwn treatment involves developing “neuron-supporting” cells from stem cells derived from the patient’s own bone marrow. In October, the U.S. Food and Drug Administration designated NurOwn as a ‘fast-track’ product to treat ALS.
CustomersPartners
growth-positive
http://www.jpost.com/Israel-News/Health/Phase-2a-clinical-trial-of-BrainStorm-stem-cell-product-shows-clinical-benefit-386767
BrainStorm Cell Therapeutics Inc. has reported that nearly all patients who underwent stem cell treatment for amyotrophic lateral sclerosis (ALS) developed by the company and tested in a Phase 2a clinical trial showed clinical benefit. The trial was carried out at the Hadassah University Medical Center in Jerusalem’s Ein Kerem. The stem cell technology is called NurOwn, which were given to 14 subjects at the hospital. The study achieved its primary endpoint in demonstrating that NurOwn is safe and well-tolerated at doses up to 2 million cells per kg. Shares in the company have nearly doubled in the past two sessions on Nasdaq in anticipation of the trial’s results.
CustomersInvestment
growth-positive
http://www.jpost.com/Health-and-Science/FDA-approves-US-phase-II-clinical-trials-on-for-ALS-treatment-initiated-at-Jerusalems-Hadassah-350676
BrainStorm Cell Therapeutics, based in Petah Tikva, Israel, has received approval from the US Food and Drug Administration to begin phase-II clinical trials for a treatment for amytrophic lateral sclerosis (ALS) using cultured and modified adult stem cells. The treatment was first introduced by Prof. Dimitrios Karousis at Hadassah-University Medical Center in Jerusalem. The trial will be launched at the Massachusetts General Hospital and the University of Massachusetts Memorial Hospital, and later at the Mayo Clinic in Minnesota. The treatment involves the injection of stem cells into the spinal fluid of ALS patients, and the trial will take about a year.
InvestmentExpand
BrainStorm Team
Bob Dagher
Executive Vice President and Chief Development Officer
Alla Patlis
Interim Chief Financial Officer
Yossef Levy
VP Cell Production
Netta Blondheim-Shraga
Vice President of Research & Development
Antonio Trejo
Vice President, Regulatory Affairs
Employee Info
| Employees (range) | 11-50 |
| Exact count | 32 |
| Team members | 10 |
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Admin Info
| Confidence | 92/100 |
| Missing | markets, not claimed |
| BI Verification | Sharon Shapira |
| Registrar ID | 513601021 |
| Crunchbase | brainstorm-cell-therapeutics |
| Phone | +97239236384 |
| Last updater | Yanina Wainscheinker |
| Updater email | yanina.wainscheinker@sncentral.org |
| Last update | 2023-12-28T00:00:00.000Z |
| Created | 2014-11-23T00:00:00.000Z |
| Claimed | Yes |
| Status detail | Public on NASDAQ on Oct, 2003<br> |