BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement.
BrainStorm Cell Therapeutics Inc
Tuesday, 23 July 2024
Intrinsic Price (USD) | 5.98 |
Value Range Low (USD) | 5.68 |
Value Range High (USD) | 6.28 |
Implied MCAP (USD) (m) | 805.5 |
Implied EV (m) | 808.1 |
XNAS | BCLI |
Financial Year End | 31-Dec |
Currency | USD |
Business Activity
Biotechnology & Medical Research
Key metrics
Close Price (USD) | 0.35 |
MCAP (USD) (m) | 27.6 |
Net Debt (Cash) (m) | -2.58 |
EV (m) | 25.0 |
52 Wk Hi | 1.90 |
52 Wk Lo | 0.13 |
Key ratios
(Net Cash) /Shareholder Equity % | 9.36% |
Healthcare Sector Research
NasdaqCM Market Index
Analyst Team
+44 20 7419 7928
healthcare@acfequityresearch.com
Company overview
BrainStorm Cell Therapeutics Inc. (Nasdaq: BCLI) develops NurOwn® stem cell therapy for NDDs – BCLI’s first target is ALS (MND/Lou Gehrig’s). Since initiation – 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 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. Due to the significant derisking progress news, our highly conservative NPV (smaller US market only) has been raised. New beta remains highly conservative at 1.0 and reduces our risk adjusted WACC. 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 (past success).… To read more download note here
➢ Institutional raise gross proceeds US$4m positive price impact
➢ Warrants in the money ~US $8.1m potential cash inflows
➢ FDA CMC questions addressed clearing pathway to trial
➢ PIIIb trial likely to start within 120 days
➢ Cash & CE estimate at date of note post raise ~US$ 3.7m
Price relative BCLI (lighter line) vs. Nasdag Biotech (NBI)
Investment Case
BrainStorm Cell Therapeutics Inc. (Nasdaq: BCLI) has developed a proprietary technology platform, NurOwn® (debamestrocel, MSC-NTF), that induces bone marrow derived autologous mesenchymal stem cells (MSCs) to secrete elevated levels of neurotrophic factors (NTFs); key to prolonging neuron survival and improving neurological function. NurOwn® has shown positive statistically significant clinical effects for the treatment of ALS in early-stage sufferers in post hoc PIII trial data analysis, supported by biomarker data. BCLI is also assessing NurOwn® for other neurogenerative disease indications. Our highly conservative NPV valuation excludes all but the smaller (by number of patients) US market.
Why is BCLI’s PIIIb trial advantageous to investors? Post hoc analysis of BCLI’s PIII early stage (mild-moderate) sub-group of ALS sufferers 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 >=40. 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 is successful, we expect a strongly positive valuation inflection point for BCLI... To read more download note
Phase III Post Hoc Analysis – Reveals Clincial Effectiveness
NurOwn (debamestrocel, MSC-NTF), therapy PIII trial results post hoc analysis of the data suggests that there is a clinically significant effect on earlier stage ALS patients, as defined by using the ALSFRS-R scale.
Though the peer reviewed PIII clinical paper (Muscle & Nerve, accepted 7th Dec 2021) states both in the results and discussions sections that across the entire trial cohort primary efficacy and secondary endpoints were not met, this is a long way from the full and positive clinical story.
The PIII clinical paper referred to above concluded that a) for the primary endpoint there was no difference in the response rate (participants with at least 1.25 points/month change in rate of disease progression as measured by the ALSFRS-R slope) and that b) the secondary endpoints were also not met, as summarized by a >=100% improvement measured by the ALSFRS-R slope , CAFS and SVC. However, post-hoc analysis of cohort pre-specified study sub-groups revealed a different outcome.
PIII post hoc analysis revealed several key points –To read more download note
Brainstorm Therapeutics Financials 2026E – 2029E US$(m)
2026E
2027E
2028E
2029E
BrainStorm Cell Therapeutics catalysts
➢ Rerating – Approved U.S. FDA design Phase IIIb trial commencement
➢ Phase IIIb peer reviewed tiral results
➢ Increased NPV – Inclusion of European ALS market in our DCF
➢ Progress on pipeline candidate targeting progressive multiple sclerosis (PMS)