Executive Summary

Q3 delivered a narrower net loss and EPS beat versus S&P Global consensus amid continued pre-revenue operations and disciplined OpEx; net loss was $2.1M and EPS was -$0.19 vs -$0.39 consensus, driven by lower G&A and R&D versus prior year . S&P Global estimates marked with * (see tables).
Liquidity remains the key risk: cash, cash equivalents and restricted cash fell to ~$0.23M at quarter-end, with accounts payable of $6.42M and stockholders’ deficit of -$7.69M; the company subsequently raised a small convertible note ($143,750 principal) on Nov 10 with a 25% conversion discount upon default, highlighting dilution risk .
Regulatory path advanced: FDA has cleared the Phase 3b ENDURANCE trial (200 patients; 24-week DB Part A + 24-week OLE Part B) designed under SPA to support a BLA if Part A meets prespecified endpoints; management is advancing pre‑initiation activities and plans an investor call in late Q4 2025 or early Q1 2026 .
External developments may influence sentiment: the FDA is considering an ALS community Citizen Petition to re-review NurOwn data, and BCLI shares transitioned from Nasdaq to OTCQB on July 18 due to minimum equity non-compliance .

What Went Well and What Went Wrong

What Went Well
- FDA-cleared Phase 3b ENDURANCE trial with SPA; management says operational readiness is progressing across sites and manufacturing, with Part A designed to support a BLA filing upon success .
- Expense discipline: G&A decreased to $1.1M (from $2.0M y/y) and R&D to $0.9M (from $1.0M y/y), contributing to a narrower net loss of $2.1M (vs $2.7M y/y) and EPS of -$0.19 (vs -$0.51 y/y) .
- Positive tone on trial execution: “We are making steady progress toward stabilizing our financial situation and initiating our Phase 3b study of NurOwn… FDA has cleared the planned clinical study” — Chaim Lebovits, CEO .
What Went Wrong
- Liquidity strain: quarter-end cash, cash equivalents and restricted cash of ~$0.23M against accounts payable of $6.42M and a stockholders’ deficit of -$7.69M underscores near-term funding urgency .
- Capital markets downgrade: Nasdaq delisting and transition to OTCQB, which can impact liquidity/visibility for the shares .
- Post-quarter financing risk: a small convertible note ($143,750 principal; OID; 10% one-time interest; 25% discount to 20-day low on default; 4.99% ownership cap) signals constrained access to capital and potential dilution upon default-triggered conversion .

Financial Results

Metric	Q3 2024	Q1 2025	Q2 2025	Q3 2025
Research & Development Expense ($M)	1.045	1.304	1.120	0.899
General & Administrative Expense ($M)	2.003	1.785	1.453	1.148
Net Loss ($M)	2.708	2.864	2.903	2.106
Diluted EPS ($/share)	-0.51	-0.45	-0.34	-0.19
Cash, Cash Equivalents & Restricted Cash ($M)	—	~1.8	~1.03	~0.23
Shares Outstanding (Period End, M)	—	7.911	10.120	11.035

EPS vs. S&P Global Consensus

Metric	Q1 2025	Q2 2025	Q3 2025
EPS Actual ($/share)	-0.45	-0.34	-0.19
EPS Consensus Mean ($/share)*	-0.97	-0.33	-0.39
Outcome vs Consensus	Beat	Miss	Beat

Estimates marked with * are values retrieved from S&P Global.

Balance Sheet (selected items)

Item	Dec 31, 2024	Sep 30, 2025
Accounts Payable ($M)	6.080	6.420
Short-term Loans ($M)	0.300	0.101
Stockholders’ Deficit ($M)	-7.764	-7.693

KPIs and Operating Items (Q3 2025)

Cash, cash equivalents and restricted cash: ~$0.23M
R&D expense: $0.9M; G&A: $1.1M
Net loss: $2.1M; EPS: -$0.19
Shares outstanding: 11.0M at quarter end

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Financial guidance (Revenue, EPS, margins)	FY2025	Not provided	Not provided	Maintained (none issued)
Phase 3b ENDURANCE design and intent	Trial Part A (24 weeks)	FDA-cleared to initiate; Part A success expected to support BLA	Advancing pre‑initiation activities; Part A still intended to support BLA	Maintained

Earnings Call Themes & Trends

Topic	Q1 2025 (Prev-2)	Q2 2025 (Prev-1)	Q3 2025 (Current)	Trend
Regulatory/SPA	Emphasized SPA; FDA clearance to initiate; alignment on CMC	FDA clearance reiterated; trial to support BLA upon Part A success	FDA-cleared; pre-initiation underway; investor call planned late Q4/early Q1	Stable progress toward initiation
Trial design & endpoints	200 pts; Part A DB 24w + Part B OLE 24w; ALSFRS-R primary	Same; sites and CDMO readiness discussed	Same; “operational readiness” reiterated	Consistent
Biomarkers/genetics	NfL reductions and UNC13A pharmacogenomics discussed	UNC13A data featured at ISCT 2025	No new data; noted Citizen Petition interest	Continuing scientific narrative
Manufacturing	Initial manufacturing at Tel Aviv; LOI for scale-up (Pluri)	LOI with Minaris Advanced Therapies (CDMO)	Working with selected manufacturing partners	Capacity building
Funding/liquidity	Funding essential; pursuing strategic investment & grants	Cash ~$1.03M at Q2-end	Cash ~$0.23M at Q3-end; subsequent small convertible note in Nov	Deteriorating cash; reliance on financing
Listing/Corporate	—	Announced upcoming Nasdaq delisting, move to OTCQB (July)	Traded OTCQB (context); shareholder law firm outreach in Oct	Governance/visibility overhang

Note: No Q3 2025 earnings call transcript was available; the company indicated it plans to host a call in late Q4 2025 or early Q1 2026 .

Management Commentary

“We are making steady progress toward stabilizing our financial situation and initiating our Phase 3b study of NurOwn… We also continue to engage with regulatory authorities and are pleased that the FDA has cleared the planned clinical study.” — Chaim Lebovits, President & CEO .
“The upcoming Phase 3b ENDURANCE study… is expected to enroll approximately 200 participants… The primary efficacy measure will be change from baseline to Week 24 on the ALSFRS-R. Data from Part A is expected to support a Biologics License Application (BLA).” .
The company acknowledged an ALS community Citizen Petition requesting renewed FDA review as a constructive development and noted it did not participate in drafting or submission .

Q&A Highlights

(From Q1 2025 call; no Q3 call transcript available)

Trial design and regulatory: Management reiterated the SPA framework and FDA alignment on CMC; Part A results at 24 weeks are intended to support a BLA if prespecified criteria are met .
Biomarkers and mechanism: Presented data on NfL trends and preclinical neuroprotection under hypoxic stress; described immunomodulatory and neuroregenerative effects consistent with NurOwn’s multimodal mechanism .
Genetics (UNC13A): Discussed exploratory pharmacogenomic response; not yet at the level for stratification in the SPA trial but will analyze post hoc .
Manufacturing capacity: Initial production at Tel Aviv with planned scale-up (Pluri) and eventual U.S. capabilities; rolling enrollment envisioned .
Funding: Emphasized need for strategic capital and pursuit of grants to initiate and complete the trial .

Estimates Context

Q3 2025 EPS was -$0.19 vs S&P Global consensus of -$0.39 (beat); revenue remained at $0 estimate as BCLI is pre-revenue *.
Prior quarters: Q1 2025 EPS -$0.45 vs -$0.97 (beat); Q2 2025 EPS -$0.34 vs -$0.33 (slight miss) *.
Coverage depth remains thin: only 1 EPS estimate for Q3 2025; target price consensus shows 2 estimates at $20.675 (interpret with caution given OTC listing and small-cap dynamics)*.
Consensus recommendation was not available in the S&P Global feed for the period*.

Coverage/Targets

Item	Q3 2025
EPS Consensus Mean ($/sh)*	-0.39
Revenue Consensus Mean ($M)*	0.0
EPS – # of Estimates*	1
Target Price Consensus Mean ($)*	20.675
Target Price – # of Estimates*	2

Estimates marked with * are values retrieved from S&P Global.

Key Takeaways for Investors

Funding is the dominant near-term variable: ~$0.23M in cash at Q3-end and rising payables necessitate prompt capital; the November convertible note illustrates reliance on small, potentially dilutive instruments .
Regulatory setup is intact: SPA in place, FDA-cleared Phase 3b, and active site/manufacturing preparation frame a potentially binary Part A readout path to a BLA upon success .
External sentiment drivers: FDA consideration of the Citizen Petition and the timing of Phase 3b start are likely stock catalysts; OTCQB listing may reduce liquidity/coverage, adding volatility .
Operating discipline is evident (lower G&A/R&D y/y), supporting EPS outperformance vs consensus in Q3 despite no revenue; however, that cannot offset funding needs .
Watch for concrete milestones: trial site activations, first-patient-in, CDMO agreements finalized, and financing updates (grants/strategic partnerships vs dilutive notes) .
Balance sheet quality matters: stockholders’ deficit and payables underscore risk to timelines if capital is delayed; subsequent financings and terms will shape dilution and execution capacity .

Appendix: Additional Context from Q3 Period

Nasdaq delisting notice; shares transitioned to OTCQB on July 18, 2025 (symbol unchanged) .
Regulatory/public policy: FDA consideration of the ALS community’s Citizen Petition for renewed NurOwn data review; company supportive but not a participant in the filing .
Financing subsequent to quarter-end: Labrys Fund II note ($143,750 principal; OID; 10% one-time interest; maturity Nov 10, 2026; convertible at 75% of the 20-day low upon default; 4.99% beneficial ownership cap) .

S&P Global estimate disclaimer: All values marked with * in tables/sections are retrieved from S&P Global.

BRAINSTORM CELL THERAPEUTICS INC. (BCLI)·Q3 2025 Earnings Summary