ACF Equity Research
FROM ACF EQUITY RESEARCH HEALTHCARE TEAM
LONDON, July 24,
2024 /PRNewswire/ --
NASDAQ: BCLI
READ ACF EQUITY RESEARCH'S UPDATE NOTE HERE
READ ACF EQUITY RESEARCH'S RELATED THEMATIC RESEARCH NOTE ON
REGENERATIVE MEDICINE – NEURODEGENERATIVE DISEASE STEM CELLS &
ALS/MND/LOU GEHRIG'S HERE
UPDATE NOTE: BrainStorm Cell Therapeutics Inc. (Nasdaq: BCLI)
develops NurOwn® stem cell therapy for Neurodegenerative diseases
(NDDs) – BCLI's first target is ALS (MND/Lou Gehrig's). Since initiation – PIIIb
rollout begins. CMC FDA questions resolved, commercialization
team in place, raised US$ 4m (gross)
enabling PIIIb rollout start, signed a CRO and lined up a
commercial manufacturer, shortening the Biologics Licence
Application (BLA) timeline. Whilst the US$
4m raise and new warrants dilution effect has reduced our
value range ~5%, it remains well above our >10x return
investment hypothesis. Our dilution bear case delivers >8x
return at recent closes and we are yet to add NPVs for the European
Union (EU) and United Kingdom
(UK). Driving factors include the significant derisking progress
news via the FDA CMC news and hiring of an experienced
commercialization team, suggesting confidence in the NurOwn® stem
cell therapy efficacy data to date for early to mid-stage ALS
sufferers. Our highly conservative NPV (smaller US market only) has
been raised. Our new market volatility (beta) assumption remains
highly conservative at 1.0 vs. the public beta of 0.36. The new
(+old) total ~20.7m warrants at 0.39c offer a further potential
US$ 8.1m of cash inflows. BCLI is
also exploring non-dilutive grant funds (an avenue of success
visited before by BCLI).
Why is BCLI's PIIIb trial advantageous to investors? BCLI's PIII
early stage (mild-moderate) sub-group of ALS sufferers treated with
BCLI's NurOwn® (stem cell therapy) revealed positive clinical
responses with respect to slowing of ALS disease progression
(primary endpoint). Biomarker data is also supportive. PIIIb trial
data (if successful) can convey competitive commercialization
advantages and derisks the post-trials process to
commercialization. The new PIIIb trial is designed to recruit a
cohort of participants with ALSFRS-R scores >=40. If the new
trial is successful, we expect a strong positive BCLI valuation
inflection point.
ALS: High Unmet Medical Need, 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).
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issuer, from an exchange, from a portfolio manager; from an
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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
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SOURCE ACF Equity Research