Brainstorm Cell Therapeutics I Stock Price, News & Analysis

BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced the acceptance of two abstracts featuring NurOwn® (MSC-NTF or Debamestrocel) at the 2024 Annual Northeastern Amyotrophic Lateral Sclerosis Consortium (NEALS) Meeting. The company's priority is initiating a Phase 3b clinical trial to confirm NurOwn's efficacy in early-stage ALS patients. Two presentations are scheduled:

1. "Debamestrocel Long-Term Benefits on Survival and Neurodegeneration in ALS Expanded Access Program" by Bob Dagher, MD.

2. "An Overview of The Phase 3b Clinical Trial of Debamestrocel in ALS" by Bob Dagher, MD.

NurOwn® is an autologous MSC-NTF cell therapy targeting neurodegenerative disorders, with ALS as the lead program. The clinical program has provided insights into ALS pathology, disease progression, and treatment.

BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced Q2 2024 financial results and provided a corporate update. Key highlights include:

1. Alignment with FDA on CMC aspects for planned Phase 3b NurOwn® trial in ALS

2. Special Protocol Assessment (SPA) agreement in place for the trial

3. Appointment of new EVP and COO, and promotion of new EVP and CMO

4. Q2 2024 financial results: Cash position of $3.65 million, R&D expenses of $0.9 million, G&A expenses of $2.0 million, net loss of $2.5 million ($0.04 per share)

5. Successful registered direct offering raising $4.0 million

The company is progressing with preparations for the Phase 3b trial, including CRO selection and engagement with ALS centers for trial sites.

BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a developer of adult stem cell therapeutics for neurodegenerative diseases, has announced a conference call on August 14, 2024, at 8:30 a.m. Eastern Time. The call will cover financial results for the second quarter ended June 30, 2024, and provide a corporate update. CEO Chaim Lebovits will present, joined by COO Haro Hartounian, CMO Bob Dagher, and Interim CFO Alla Patlis to answer questions. Participants can submit questions in advance to q@brainstorm-cell.com by August 12, 2024. The call can be accessed via toll-free (877-545-0523) or international (973-528-0016) numbers, with access code 308245. A webcast and 14-day replay will also be available.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) has made significant progress in developing NurOwn®, a stem cell therapy for neurodegenerative diseases, particularly ALS. Key developments include:

1. Resolution of FDA CMC questions
2. Establishment of a commercialization team
3. Raising $4 million to start Phase IIIb rollout
4. Signing a CRO and lining up a commercial manufacturer

These advancements have shortened the Biologics Licence Application timeline. Despite dilution from the recent fundraising, ACF Equity Research maintains a >10x return investment hypothesis. The Phase IIIb trial, focusing on early to mid-stage ALS patients, could provide competitive advantages if successful. BCLI is also exploring non-dilutive grant funding options.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced a mid-year corporate update on its NurOwn® program scheduled for July 8, 2024, at 8:00 a.m. Eastern Time. The update will focus on recent positive developments in NurOwn®, a therapy for neurodegenerative diseases. CEO Chaim Lebovits, COO Hartoun Hartounian, and Chief Development Officer Bob Dagher will present. A Q&A session will follow, with questions to be submitted by July 5, 2024, at 10:00 a.m. Participants can join via conference call or webcast, with replay available until July 22, 2024.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced a $4.0 million registered direct offering with a single institutional investor. The deal includes the sale of 11,111,111 shares at $0.36 each and unregistered warrants for 16,666,667 shares at $0.3912 each, exercisable in six months and expiring in five years. Existing warrants' exercise price will be reduced to $0.3912 and expiration extended to 2029. The offering will close around June 28, 2024, and Maxim Group is the placement agent. The offering is made under a shelf registration statement filed with the SEC.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) has reached alignment with the FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of its Phase 3b clinical trial for NurOwn, a therapy for amyotrophic lateral sclerosis (ALS). This development follows the FDA’s Special Protocol Assessment (SPA) agreement granted in April 2024, which provided clarity on the trial design and endpoints. The Type C meeting resolved all outstanding CMC questions, allowing BrainStorm to proceed with the pivotal trial. Chaim Lebovits, CEO, expressed satisfaction with the outcome, emphasizing the importance of alignment in manufacturing complexities and the company's commitment to advancing ALS treatment.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) has appointed Dr. Haro Hartounian as the new EVP and COO, effective June 18, 2024. Dr. Hartounian brings over 32 years of biopharma experience, notably founding BioCentriq, a cell and gene therapy CDMO, acquired for $73 million in 2022. His expertise encompasses managing large pharmaceutical operations and biotech start-ups. As COO, he will oversee BrainStorm's operational efficiency, CMC, and commercialization strategies, particularly for NurOwn®, their ALS treatment. The appointment aligns with the launch of a Phase 3b ALS study, aiming to enhance the company's therapeutic platforms.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) is advancing its autologous mesenchymal stem cell (MSC) therapy, NurOwn® (debamestrocel, MSC-NTF), targeting neurodegenerative diseases, primarily ALS. Post hoc analysis of Phase III data reveals significant clinical benefits for early-stage ALS patients, prompting the FDA to back a new Phase IIIb trial under an SPA agreement. The Phase IIIb trial aims to enroll ALS patients with ALSFRS-R scores ≥35, focusing on slowing disease progression. Peer-reviewed studies also highlight NurOwn's positive impact on ALS biomarkers, supporting its potential efficacy. BCLI has met the NASDAQ minimum value compliance and anticipates strong valuation growth if the Phase IIIb trial succeeds.