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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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