Research Coverage on Small and Micro-Cap Companies, Zacks Small Cap Research

Zacks Small Cap Research

Research Coverage on Small and Micro-Cap Companies

Zacks Small Cap Research provides research coverage on small- and micro-cap companies that are “under-followed” or “under-valued” by Wall Street. We produce high quality equity research for the institutional and retail investor on microcap firms we believe are well positioned for future growth. The Zacks SCR analyst team has an average of 20 years of experience in investment research. We conduct significant due diligence in an effort to maintain the highest quality small-cap universe.

Equity Bottom-Up

BrainStorm Cell Therapeutics I / Equity Bottom-Up

<ul><li>On August 14, 2025, BrainStorm Cell Therapeutics, Inc. (BCLI) announced financial results for the second quarter of 2025 and provided a business update.</li><li>The company continues to be focused on initiating the Phase 3b ENDURANCE trial of NurOwn for the treatment of amyotrophic lateral sclerosis (ALS).</li><li>Following the filing of the Citizen's Petition in July 2025, we await a decision from the FDA regarding that petition and whether the agency will invite BrainStorm to resubmit the Biologics License Application (BLA) for NurOwn in ALS.</li></ul>

On August 14, 2025, BrainStorm Cell Therapeutics, Inc. (BCLI) announced financial results for the second quarter of 2025 and provided a business update.The company continues to be focused on initiating the Phase 3b ENDURANCE trial of NurOwn for the treatment of amyotrophic lateral sclerosis (ALS).Following the filing of the Citizen's Petition in July 2025, we await a decision from the FDA regarding that petition and whether the agency will invite BrainStorm to resubmit the Biologics License Application (BLA) for NurOwn in ALS.

BCLI: Focused on Initiation of Phase 3b ENDURANCE Trial of NurOwn  in ALS 

<ul><li>On July 3, 2025, a Citizen's Petition was filed with the U.S. Food and Drug Administration that is asking the agency to invite BrainStorm Cell Therapeutics, Inc. (BCLI) to re-file its Biologics License Application (BLA) for debamestrocel (NurOwn ) for the treatment of amyotrophic lateral sclerosis (ALS).</li><li>In addition, the petition is requesting the FDA use its "regulatory flexibility" to grant Accelerated Approval or a new Conditional Approval for NurOwn with a Phase 4 confirmatory study.</li><li>The petition includes data and analysis from all of NurOwn's clinical trials along with additional data from the Expanded Access Program (EAP) that shows 10/10 participants lived greater than 5 years, compared to 20% expected five-year survival based on ALS natural history data.</li></ul>

On July 3, 2025, a Citizen's Petition was filed with the U.S. Food and Drug Administration that is asking the agency to invite BrainStorm Cell Therapeutics, Inc. (BCLI) to re-file its Biologics License Application (BLA) for debamestrocel (NurOwn ) for the treatment of amyotrophic lateral sclerosis (ALS).In addition, the petition is requesting the FDA use its "regulatory flexibility" to grant Accelerated Approval or a new Conditional Approval for NurOwn with a Phase 4 confirmatory study.The petition includes data and analysis from all of NurOwn's clinical trials along with additional data from the Expanded Access Program (EAP) that shows 10/10 participants lived greater than 5 years, compared to 20% expected five-year survival based on ALS natural history data.

BCLI: Citizen's Petition Filed Requesting the FDA Approve NurOwn  

<ul><li>On May 19, 2025, BrainStorm Cell Therapeutics, Inc. (BCLI) announced that the U.S. Food and Drug Administration (FDA) has cleared the company to initiate the Phase 3b clinical trial of NurOwn for the treatment of amyotrophic lateral sclerosis (ALS).</li><li>This final regulatory clearance comes after the company submitted an amendment to the Investigational New Drug (IND) application regarding certain technical aspects of the Chemistry, Manufacturing, and Controls (CMC).</li><li>The trial design was previously agreed upon with the FDA under a Special Protocol Assessment (SPA).</li></ul>

On May 19, 2025, BrainStorm Cell Therapeutics, Inc. (BCLI) announced that the U.S. Food and Drug Administration (FDA) has cleared the company to initiate the Phase 3b clinical trial of NurOwn for the treatment of amyotrophic lateral sclerosis (ALS).This final regulatory clearance comes after the company submitted an amendment to the Investigational New Drug (IND) application regarding certain technical aspects of the Chemistry, Manufacturing, and Controls (CMC).The trial design was previously agreed upon with the FDA under a Special Protocol Assessment (SPA).

BCLI: Receives Regulatory Clearance to Initiate Phase 3b ALS Trial 

Research from ACF Equity Research, ACF Equity Research

ACF Equity Research

Research from ACF Equity Research

Accuracy | Clarity | Foresight

ACF was set up to improve the effectiveness of capital markets for smaller and mid-sized companies. The majority of jobs are created by smaller companies not global companies. If we can help improve companies use of capital markets more projects will be completed, more jobs created, more global GDP grown, which in turn helps create more resources for education, leading to equality and opportunity for those who are still oppressed by ignorance and poverty.

ACF Equity Research is an independent research house specialising in the highest specification independent equity research for corporate clients.

We deliver premium independent corporate sponsored equity research characterised by its accuracy, clarity and foresight based upon a fundamental valuation approach.

Our independent research is designed to educate our professional investor readers about your company, with an emphasis on clear and accurate explanations. Our mission is to improve company’s liquidity through credible equity research services, excellent international distribution and reliable access for investment managers.

We believe in the importance and value of clarity, the careful articulation of technical ideas, concepts and solutions.

Our team of analysts are independently minded individuals who believe in thoroughness, technical competence and clear punchy communications.

<ul><li>BrainStorm Cell Therapeutics Inc. (Nasdaq: BCLI) develops NurOwn® stem cell therapy for NDDs – BCLI’s first target is ALS (MND/Lou Gehrig’s).</li><li>Recent micro capitalization and patent development buy time for non-dilutive funding to be secured.</li><li>BCLI’s Nasdaq compliance for minimum price was regained in late Oct 24, which helps maintain capital access.</li></ul>

BrainStorm Cell Therapeutics Inc. (Nasdaq: BCLI) develops NurOwn® stem cell therapy for NDDs – BCLI’s first target is ALS (MND/Lou Gehrig’s).Recent micro capitalization and patent development buy time for non-dilutive funding to be secured.BCLI’s Nasdaq compliance for minimum price was regained in late Oct 24, which helps maintain capital access.

BrainStorm Cell Therapeutics (BCLI) - Fundamentals Update 09042025

<ul><li>On December 30, 2024, BrainStorm Cell Therapeutics, Inc. (BCLI) held a conference call to provide a corporate update.</li><li>The company remains on track to conduct a Phase 3b trial of NurOwn in patients with amyotrophic lateral sclerosis (ALS) to support a potential Biologics License Application (BLA) filing.</li><li>During 2024, BrainStorm reached agreement with the FDA on a Special Protocol Assessment (SPA) and the CMC aspects of the upcoming trial, which significantly de-risks the regulatory aspects of the program.</li></ul>

On December 30, 2024, BrainStorm Cell Therapeutics, Inc. (BCLI) held a conference call to provide a corporate update.The company remains on track to conduct a Phase 3b trial of NurOwn in patients with amyotrophic lateral sclerosis (ALS) to support a potential Biologics License Application (BLA) filing.During 2024, BrainStorm reached agreement with the FDA on a Special Protocol Assessment (SPA) and the CMC aspects of the upcoming trial, which significantly de-risks the regulatory aspects of the program.

BCLI: Plans Coming Together for Phase 3b Trial of NurOwn  in ALS 

United States

BrainStorm Cell Therapeutics Inc. is a biotechnology company developing autologous adult stem cell therapies for neurodegenerative disorders such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS) and Parkinson's disease (PD).

Price Gauge
52-week Range	0.00 - 0.00
Market Cap (USDm)	0.00
P/E	0.00
Dividend (Yield)	0.00

BrainStorm Cell Therapeutics I (BCLI US)

BCLI: Focused on Initiation of Phase 3b ENDURANCE Trial of NurOwn in ALS

On August 14, 2025, BrainStorm Cell Therapeutics, Inc. (BCLI) announced financial results for the second quarter of 2025 and provided a business...

Zacks Small Cap Research

BCLI: Citizen's Petition Filed Requesting the FDA Approve NurOwn

On July 3, 2025, a Citizen's Petition was filed with the U.S. Food and Drug Administration that is asking the agency to invite BrainStorm Cell...

Zacks Small Cap Research

BCLI: Receives Regulatory Clearance to Initiate Phase 3b ALS Trial

On May 19, 2025, BrainStorm Cell Therapeutics, Inc. (BCLI) announced that the U.S. Food and Drug Administration (FDA) has cleared the company to...

Zacks Small Cap Research

BrainStorm Cell Therapeutics (BCLI) - Fundamentals Update 09042025

BrainStorm Cell Therapeutics Inc. (Nasdaq: BCLI) develops NurOwn® stem cell therapy for NDDs – BCLI’s first target is ALS (MND/Lou...

ACF Equity Research

BCLI: Plans Coming Together for Phase 3b Trial of NurOwn in ALS

On December 30, 2024, BrainStorm Cell Therapeutics, Inc. (BCLI) held a conference call to provide a corporate update. The company remains on track...

Zacks Small Cap Research

Price Gauge

52-week Range

Market Cap (USDm)

P/E

Dividend (Yield)