Executive Summary

BCLI reported Q1 2025 net loss of $(2.86)M and diluted EPS of $(0.45), improving year over year from $(3.40)M and $(0.75) as lower warrant fair value losses offset higher operating expenses .
EPS materially beat thin Wall Street consensus (n=1): -$0.45 vs -$0.97, a +$0.52 surprise; revenue remained $0 as a pre-revenue biotech (est $0) [Q1 2025 estimates from S&P Global]*.
Operationally, the FDA cleared BCLI to initiate its Phase 3b ENDURANCE trial under an SPA; management is finalizing site CTAs (~15 U.S. centers), scaling manufacturing (Tel Aviv Sourasky; tech transfer to Pluri; new LOI with Minaris in NJ) and awaits potential non‑dilutive funding (a $15M grant under review) .
Near-term stock catalysts: site activations and first‑patient‑in, non‑dilutive grant decision(s), Minaris/Pluri manufacturing milestones, and any partnership/financing updates that de‑risk enrollment and timeline .

What Went Well and What Went Wrong

What Went Well

FDA clearance to initiate Phase 3b under SPA, materially de‑risking regulatory pathway and enabling site activation and patient enrollment .
Manufacturing network strengthened: initial production at Tel Aviv Sourasky; tech transfer to Pluri; new LOI with Minaris to add U.S. capacity (Allendale, NJ) .
EPS outperformed consensus as warrant fair value impact moderated YoY (-$0.18M vs -$0.94M), improving net loss despite higher OpEx .
Management tone confident on trial readiness: “This regulatory clearance marks a significant milestone, bringing us closer to commencing patient enrollment” (CEO) .

What Went Wrong

Liquidity remains tight: cash & equivalents of $1.64M and restricted cash $0.18M at quarter‑end; current liabilities rose QoQ (short‑term loans $1.20M vs $0.30M) .
Funding is the gating factor to enrollment pace; management highlighted need for robust funding and is pursuing grants/partnerships, with a $15M non‑dilutive grant under review .
OpEx rose YoY as execution ramped (R&D $1.304M vs $0.961M; G&A $1.785M vs $1.513M) while still no revenue, extending reliance on external financing .

Financial Results

P&L and EPS vs Prior Periods

Metric	Q1 2024	Q3 2024	Q4 2024	Q1 2025
Research & Development ($USD Millions)	$0.961	$1.045	n/a (FY only disclosed)	$1.304
General & Administrative ($USD Millions)	$1.513	$2.003	n/a (FY only disclosed)	$1.785
Total Operating Expenses ($USD Millions)	$2.474	$3.048	n/a (FY only disclosed)	$3.089
Net Loss ($USD Millions)	$(3.401)	$(2.708)	n/a (FY only disclosed)	$(2.864)
Diluted EPS ($)	$(0.75)	$(0.51)	n/a (FY only disclosed)	$(0.45)

Notes: BCLI reported no product revenues; statements present only operating expenses (pre‑revenue biotech) .

Liquidity and Balance Sheet (selected)

Metric	Dec 31, 2024	Mar 31, 2025
Cash & Cash Equivalents ($USD Millions)	$0.187	$1.644
Restricted Cash ($USD Millions)	$0.184	$0.182
Accounts Payable ($USD Millions)	$6.080	$6.797
Short‑Term Loans ($USD Millions)	$0.300	$1.200
Total Current Liabilities ($USD Millions)	$8.978	$10.901
Stockholders’ Deficit ($USD Millions)	$(7.764)	$(7.457)

Versus Estimates (S&P Global)

Metric	Q1 2025 Estimate*	Q1 2025 Actual	Surprise
Primary EPS ($)	-0.97*	-0.45	+0.52
Revenue ($USD Millions)	0.00*	0.00 (pre‑revenue)	0.00

Values marked with * retrieved from S&P Global. Coverage thin (n=1 for both EPS and revenue).

Drivers of EPS upside: lower loss on change in warrant fair value YoY (-$0.18M vs -$0.94M) and modest financial income, partially offset by higher R&D and G&A .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Phase 3b trial initiation (ENDURANCE)	2025	Prepare to initiate Phase 3b; SPA in place; align on CMC	FDA cleared to initiate; proceed to site activation/enrollment	Raised (progressed)
Trial design	Study duration	~200 participants; Part A 24‑week DB; primary endpoint ALSFRS‑R change at week 24	Same parameters reaffirmed; listing on ClinicalTrials.gov	Maintained
Sites/CTAs	2025	Multiple U.S. centers planned	~15 U.S. centers negotiating CTAs; one U.S. site passed FDA inspection	Increased specificity
Manufacturing footprint	2025	Pluri for clinical supply; Tel Aviv Sourasky facility	Initial at Tel Aviv; tech transfer to Pluri; new Minaris LOI (Allendale, NJ)	Expanded
Funding plan	2025	Need ~$23–30M annually; pursuing grants/partnerships; $1.64M raised via warrant inducement expected post‑Q4	$15M non‑dilutive grant under review; continue strategic funding discussions	Maintained/in progress

No financial guidance (revenue, margins, OpEx ranges) was provided; management focuses on operational milestones and financing progress .

Earnings Call Themes & Trends

Topic	Q3 2024 (Prev‑2)	Q4 2024 (Prev‑1)	Q1 2025 (Current)	Trend
Regulatory/FDA	Planning Phase 3b; design disclosed; targeting early-stage ALS	SPA secured; CMC alignment; IND technical transfer in progress	FDA cleared to initiate Phase 3b; proceed to enrollment	Positive inflection
Trial operations & sites	Working with investigators; multi‑site U.S. trial planned	Negotiating ~15 site CTAs	~15 U.S. centers negotiating; one site passed FDA inspection	Advancing
Manufacturing	Pluri MOU to support clinical supply	Tel Aviv Sourasky + Pluri; plan U.S. site	Tel Aviv start; Pluri transfer; LOI with Minaris in NJ	Capacity broadened
Funding/capital	Low cash; pursuing financing	Need ~$23–30M per year; warrant inducement ~$1.64M; grants/partners	$15M grant under review; pursuing strategic capital	Still gating factor
Biomarkers/UNC13A	Survival/NfL data presented; biomarker alignment with MOA	Trial design optimized; early‑disease focus	UNC13A data highlighted; remains exploratory for stratification	Scientific support continues
Exosome platform	Patent allowance (Dec 2024)	Expansion contemplated	Preclinical COPD/ARDS data; pursuing partnerships	Optionality improving

Management Commentary

“This regulatory clearance marks a significant milestone, bringing us closer to commencing patient enrollment” — Chaim Lebovits, CEO .
“We plan to initiate initial manufacturing at Tel Aviv Sourasky… then proceed with a technology transfer to Pluri… [and] have secured a leading U.S. clinical site that has successfully passed FDA inspection” — Hartoun Hartounian, COO .
“We are actively engaged in negotiations for… approximately 15 leading clinical centers across the United States... ENDURANCE details are posted on clinicaltrials.gov” — CEO .
“We are actively pursuing multiple funding avenues… including a promising $15 million nondilutive grant currently under review” — CEO .

Q&A Highlights

UNC13A stratification: FDA SPA “agreed on with all the details, including the population”; UNC13A association is “exploratory and not definitive at this stage,” though post‑hoc analyses will be pursued .
Mechanistic evidence: NurOwn‑conditioned media restored cell viability to 96.5% of normoxic conditions in a hypoxia model; data included in the IND to support MOA .
Manufacturing capacity/timeline: Rolling enrollment supported initially by Tel Aviv facility, then Pluri; U.S. manufacturing expected to come online next year .
Sites/enrollment: ~15 sites listed on ClinicalTrials.gov; CTAs to be signed gradually; plan contemplates 200‑patient trial over ~3 years to full enrollment/treatment (funding dependent) .
Funding: Multiple avenues in progress; $15M non‑dilutive grant under review; partnerships prioritized to launch and complete the study .

Estimates Context

EPS: Actual -$0.45 vs consensus -$0.97 (n=1) — a significant beat likely driven by reduced warrant fair value losses and modest financial income despite higher OpEx . Values retrieved from S&P Global*.
Revenue: Pre‑revenue; actual $0 vs consensus $0 (n=1). Values retrieved from S&P Global*.
Estimate quality: Coverage remains thin; future estimates may need to reflect higher share count and OpEx ramp as sites/manufacturing activate, as well as potential non‑cash warrant valuation effects .

Key Takeaways for Investors

Regulatory de‑risking: FDA clearance under SPA removes a key overhang and sets a clear path to enrollment; future updates on first‑patient‑in and site activations are key trading catalysts .
Funding is the gating variable: Execution pace and enrollment depend on securing capital; management is pursuing a $15M non‑dilutive grant and strategic partnerships .
Manufacturing redundancy emerging: Tel Aviv + Pluri + Minaris LOI establishes a multi‑node network that should mitigate CMC/supply risk as scale increases .
EPS beat vs thin consensus: -$0.45 vs -$0.97 (n=1) reflects lower non‑cash warrant volatility YoY; near‑term P&L variability may persist given financing and fair‑value items . Values retrieved from S&P Global*.
Balance sheet still tight: Cash & equivalents $1.64M; restricted cash $0.18M; current liabilities $10.90M — reinforcing urgency of funding updates .
Trial focus on early ALS with biomarker support: Early‑disease enrichment and ALSFRS‑R at 24 weeks remain central; UNC13A and NfL data continue to support the biological rationale, albeit exploratory for stratification .
Optionality from exosomes/IP: Preclinical signals in COPD/ARDS and expanding IP provide longer‑term upside outside NurOwn .

Sources:

Q1 2025 8‑K and Exhibit 99.1 press release (financials, balance sheet, trial and corporate updates) .
Q1 2025 earnings call transcript (FDA clearance, operations, funding, Q&A) .
FDA clearance PR (May 19) .
Minaris LOI PR (May 27) .
FY 2024 PR and Q4 2024 call (context on SPA/CMC, funding needs) .
Q3 2024 PR (prior‑quarter financials and biomarker/survival data) .

*Values retrieved from S&P Global.

BRAINSTORM CELL THERAPEUTICS INC. (BCLI)·Q1 2025 Earnings Summary