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BRAINSTORM CELL THERAPEUTICS INC. (BCLI)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 was defined by regulatory and operational progress (FDA clearance to initiate the Phase 3b ENDURANCE ALS trial; Minaris CDMO LOI), offset by continued losses and constrained liquidity; no revenue recognized .
  • EPS of $0.34 loss was essentially in line with one-estimate S&P Global consensus (-$0.34 actual vs -$0.33 est; revenue est $0.0 and actual $0.0), reflecting a development-stage cost profile with tighter G&A and modestly higher R&D .
  • Liquidity tightened: cash, equivalents, and restricted cash fell to ~$1.03M at 6/30/25 (from ~$1.8M at 3/31/25), highlighting urgency around funding options discussed by management .
  • Notable Q3-to-date events: FDA consideration of a Citizen Petition related to NurOwn and Nasdaq delisting/transition to OTCQB; both are meaningful narrative catalysts for regulatory and trading status, respectively .

What Went Well and What Went Wrong

  • What Went Well

    • FDA cleared initiation of the Phase 3b ENDURANCE trial (SPA-backed design); management reiterated that successful completion of Part A is expected to support a new BLA submission .
    • Manufacturing readiness advanced via LOI with Minaris (U.S.) and ongoing collaboration with Pluri (Israel), strengthening supply-chain optionality for a multicenter U.S. trial .
    • Management emphasized confidence and engagement with clinicians/ALS community; CEO: “We reached an important milestone in Q2 with FDA clearance…designed to generate confirmatory data to support a potential BLA submission” .

  • What Went Wrong

    • Liquidity remained very limited: ~$1.03M cash, equivalents, and restricted cash at 6/30/25 vs ~$1.8M at 3/31/25; management underscored the need to secure financing (including a potential $15M non-dilutive grant under review) before trial start .
    • Listing risk materialized post-quarter: BCLI was delisted from Nasdaq for minimum stockholders’ equity non-compliance; shares transitioned to OTCQB as of July 18, 2025 .
    • Limited sell-side coverage: only one EPS estimate and two revenue estimates for Q2, limiting signal value of the beat/miss framework for traders [GetEstimates Q2 2025].

Financial Results

MetricQ3 2024Q1 2025Q2 2025
Revenue ($M)$0.00*$0.00*$0.00*
R&D Expense ($M)$1.00 $1.30 $1.12
G&A Expense ($M)$2.00 $1.79 $1.45
Net Loss ($M)$2.71 $2.86 $2.90
Diluted EPS ($)$(0.51) $(0.45) $(0.34)
Cash, Equivalents & Restricted Cash ($M, period-end)$0.35 $1.83 (1.64+0.18) $1.03 (0.82+0.20)
  • Note: Revenue reported as $0.00 reflects development-stage status; no revenue lines disclosed in releases.
  • Values marked with * retrieved from S&P Global.

Q2 2025 vs Prior Periods and Estimates:

  • EPS: $(0.34) vs $(0.45) in Q1 2025 and $(0.60) in Q2 2024; vs S&P Global consensus of $(0.33) → slight miss by $0.01 .
  • Operating profile: R&D up modestly y/y; G&A down y/y, consistent with cost discipline .
  • Liquidity: materially lower q/q, emphasizing funding timing risk before trial execution .

Estimates vs Actuals (S&P Global)

MetricQ2 2025 ConsensusQ2 2025 Actual
EPS ($)$(0.33)$(0.34)
Revenue ($M)$0.0$0.00*
  • Consensus estimates source: S&P Global (limited coverage; EPS: 1 estimate; Revenue: 2 estimates).
  • Values marked with * retrieved from S&P Global.

KPIs (Program Execution)

KPIPriorCurrent
Planned Enrollment (Phase 3b)~200 participants ~200 participants
Anticipated U.S. Trial Sitesc. 15 listed on ClinicalTrials.gov Ongoing site engagement
Primary EndpointALSFRS-R change at week 24 ALSFRS-R change at week 24 (Part A)
Manufacturing NetworkPluri MOU (Israel) Minaris LOI (U.S.) + Pluri ongoing

Guidance Changes

Metric/AreaPeriodPrevious GuidanceCurrent GuidanceChange
Phase 3b ENDURANCE status2025IND amendment submitted; SPA agreed FDA cleared to initiate; patient enrollment preparation underway Raised/Advanced
Regulatory/BLA PathPart A (24 weeks)Part A results expected to support BLA per SPA Unchanged: Part A success expected to support BLA Maintained
Manufacturing Readiness2025Pluri MOU for supply Minaris LOI (U.S.) adds capacity; tech transfer planning Expanded
Financial Guidance2025NoneNoneMaintained
Listing Status2025Nasdaq-listedDelisted; trading on OTCQB as of July 18, 2025 Lowered (listing venue)

Earnings Call Themes & Trends

Note: Q2 2025 transcript access via the tool returned only the opening chunk; themes below leverage Q1 2025 call for continuity and the Q2 press release for updates - -.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q2 2025)Trend
Regulatory pathway (SPA/BLA)SPA agreed; Part A to support BLA; FDA alignment on CMC (Q1 call) FDA cleared initiation; reiterated Part A supports BLA Improving
Manufacturing/CDMOPluri MOU, tech transfer plans (Q3’24) Minaris LOI adds U.S. capacity; continued Pluri engagement Strengthening
Funding/cash runwayFunding required to start trial; pursuing $15M non-dilutive grant, partnerships (Q1 call) Cash down to ~$1.03M; continued focus on funding (Q2 PR) Pressured
Regulatory/legal narrativeN/AFDA considering Citizen Petition re: NurOwn data Emerging
Clinical data signalsBiomarker, UNC13A, EAP survival signals discussed (Q1 call) -EAP update: 100% (10/10) >5-year survival from symptom onset; median 6.8 years (contextual, small cohort) Supportive but exploratory
Listing/Trading venueNasdaq (prior)Delisted from Nasdaq; moved to OTCQB Negative on liquidity/visibility

Management Commentary

  • “We reached an important milestone in Q2 with FDA clearance to initiate our Phase 3b trial, designed to generate confirmatory data to support a potential BLA submission.” — Chaim Lebovits, CEO .
  • “We support the FDA’s consideration of the Citizen Petition… We continue to stand behind the integrity and rigor of our data.” — Chaim Lebovits, CEO .
  • On funding: “Securing proper funding is essential to commence the trial… pursuing multiple funding avenues, including a promising $15 million non‑dilutive grant under review and strategic partnerships.” — Chaim Lebovits (Q1 call) .
  • On trial design: “Part A is a 24‑week double‑blind period… primary endpoint is change from baseline to week 24 in ALSFRS‑R… results from Part A… should be sufficient to support a new BLA.” — Dr. Ibrahim (Bob) Dagher, CMO (Q1 call) .

Q&A Highlights

Note: The Q2 2025 transcript beyond opening remarks was not available via tool; highlights reflect Q1 2025 Q&A to indicate investor focus -.

  • Biomarker/genetics (UNC13A): FDA stratification not yet at a stage to be prespecified; remains exploratory, with further post-hoc analyses planned in Phase 3b .
  • Mechanism-of-action package: In vitro hypoxia model showed media from NurOwn cultures restored cell viability to ~96.5% of normoxic conditions; supportive data included in IND .
  • Manufacturing capacity and site activation: Rolling enrollment approach; Tel Aviv facility to start, with Pluri adding capacity; U.S. site expected later; ~15 U.S. centers listed on ClinicalTrials.gov pending CTAs - .
  • Funding: Multiple avenues including a ~$15M non-dilutive grant under review and strategic deals cited as prerequisites to trial commencement .

Estimates Context

  • Q2 2025 EPS was $(0.34) vs S&P Global consensus $(0.33) (1 estimate); Revenue $0.00 vs $0.0 consensus (2 estimates). The near-line EPS result and zero-revenue profile reflect a development-stage cost base with modest R&D y/y increase and lower G&A y/y .
  • Limited coverage implies estimates may not fully incorporate quarter-to-quarter opex mix shifts; near-term revisions are likely minimal unless funding timing or trial start visibility changes.
  • Consensus estimates source: S&P Global.

Key Takeaways for Investors

  • Regulatory de-risking improved with FDA clearance to initiate the SPA-backed Phase 3b ENDURANCE study; Part A success remains the key BLA catalyst .
  • Manufacturing strategy strengthened with Minaris LOI (U.S.) and Pluri (Israel), improving supply-chain readiness for a multicenter trial .
  • Liquidity is the gating factor: ~$1.03M at 6/30/25 underscores urgency to secure grants/partnership capital before enrollment; funding announcements are likely primary stock catalysts near-term .
  • Regulatory narrative broadened with FDA’s consideration of a Citizen Petition; any outcome or FDA commentary could shift perceived probability of success .
  • Listing transition to OTCQB may reduce trading liquidity and institutional visibility; execution/funding milestones become more important to maintain investor engagement .
  • Clinical signals (EAP survival, biomarker trends, UNC13A pharmacogenomics) remain hypothesis‑generating and supportive of further study, but not registrational on their own -.
  • For trading: watch for funding news, first patient-in timing, site activation cadence, and any FDA updates on the Citizen Petition as near-term narrative drivers .

Footnotes:

  • Consensus estimates are from S&P Global.
  • Values marked with * retrieved from S&P Global.
  • The Q2 2025 earnings call transcript was only partially accessible via the document tool (opening remarks available); Q&A themes reference Q1 2025 call for continuity -.

Citations:

  • Q2 2025 8-K and Press Release (financials, program updates): - -
  • Q1 2025 8-K and Press Release (financials, program updates): -
  • Q3 2024 8-K and Press Release (trend context): -
  • FDA clearance press release:
  • Minaris LOI press release: -
  • Citizen Petition press release: -
  • Nasdaq delisting/OTCQB transition press release: -
  • Q1 2025 earnings call transcript (themes/Q&A): -
  • Q2 2025 earnings call transcript (opening only):