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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Brainstorm Cell Therapeutics Inc | NASDAQ:BCLI | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.0204 | -5.66% | 0.34 | 0.3385 | 0.3577 | 0.38 | 0.34 | 0.379 | 507,665 | 01:00:00 |
FROM ACF EQUITY RESEARCH HEALTHCARE TEAM
NASDAQ: BCLI
READ ACF EQUITY RESEARCH'S INITIATION NOTE HERE
READ ACF EQUITY RESEARCH'S RELATED THEMATIC RESEARCH NOTE ON REGENERATIVE MEDICINE – NEURODEGENERATIVE DISEASE STEM CELLS & ALS/MND/LOU GEHRIG'S HERE
LONDON, June 14, 2024 /PRNewswire/ --
INITIATION NOTE: BrainStorm Cell Therapeutics Inc. (Nasdaq: BCLI) is focused on developing autologous mesenchymal stem cell (MSC) therapies for the treatment of neurodegenerative diseases (NDDs) – BCLI's primary target is the fatal amyotrophic lateral sclerosis (ALS/MND/Lou Gehrig's). Post hoc analysis of BCLI's PIII trial data shows BCLI's NurOwn® (debamestrocel, MSC-NTF), has statistically significant clinical effects on early-stage ALS sufferers and that placebo trialists deteriorate faster. Peer reviewed research (Mar 2024) indicated that BCLI's NurOwn® has a positive impact on NfL biomarkers for ALS. These and other factors have persuaded the FDA to sign up to the SPA binding commitment for a NurOwn® PIIIb ALS trial. BCLI has regained regulatory minimum value NASDAQ compliance. Our valuation captures only the smaller by patients US market and excludes the larger EU/UK market.
Post hoc analysis of BCLI's PIII early stage (mild-moderate) ALS sufferers (baseline ALSFRS-R scores >=35) treated with BCLI's NurOwn® (debamestrocel, MSC-NTF) revealed positive clinical responses with respect to slowing of ALS disease progression (primary endpoint). However the PIII trial cohort consisted (unexpectedly) of 23% advanced ALS sufferers, clouding the primary and secondary end point statistical analysis (possible floor effects). The new PIIIb trial is designed to recruit a cohort of participants with ALSFRS-R scores >=35. Additionally, more recent peer reviewed research found that certain biomarkers involved in ALS pathology, specifically NfL, LAP and Galectin-1 were found to be predictive of positive clinical outcomes in NurOwn® (debamestrocel, MSC-NTF),-treated participants. If the new trial design is successfully executed, as we forecast, we expect a strongly positive valuation inflection point for BCLI.
ALS: High Unmet Medical Need Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disorder (NDD) that affects motor nerve cells in the brain and the spinal cord. There are an estimated ~450k ALS patients worldwide (30k US and 51k European). Median survival post diagnosis is 2 to 5 years. Current treatment options have very limited efficacy. Tofersen addresses just 2% of ALS sufferers. There is a high unmet need to slow/reverse ALS progression.
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DISCLOSURES: ACF Equity Research has received cleared funds in advance for a minimum one year service directly from the issuer, from an exchange, from a portfolio manager; from an investor group or and from an investor relations firm. ACF Equity Research has received for any of investment/equity/credit/ESG/sustainability research a fixed paid in full in advance annual fee in the range US$35,000 to US$75,000 service package dependent.
View original content:https://www.prnewswire.com/news-releases/bcli-initiation---potential-10x-return-on-successful-phase-3b-promising-post-hoc-and-biomarker-analysis-underpins-our-nurown-clinical-effectiveness-expectation-302173201.html
SOURCE ACF Equity Research
Copyright 2024 PR Newswire
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