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LT

LISATA THERAPEUTICS, INC. (LSTA)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 showed disciplined cost control: total operating expenses fell 11.4% YoY to $5.85M, narrowing net loss to $4.72M and diluted EPS to $(0.55) versus $(0.65) in Q1 2024 .
  • EPS modestly missed S&P Global consensus by $0.02 (actual $(0.55) vs estimate $(0.53)), with revenue consensus at $0.00 given the company’s pre-revenue profile [GetEstimates].
  • Cash, cash equivalents, and marketable securities were $25.8M; management extended projected runway into Q3 2026 (no debt), an improvement versus prior updates (Q4 2024: into Q2 2026; Q3 2024: into early 2026) .
  • Near-term catalysts: ASCEND Cohort B oral at ESMO-GI (July 2–5, 2025), BOLSTER first-line CCA topline mid-2025, and Qilu’s China program moving toward Phase 3 with a potential $10M milestone upon first patient dosing .

What Went Well and What Went Wrong

What Went Well

  • “We now project having operational cash into the third quarter of 2026 as we finalize next steps in certepetide development” — CEO emphasized prudent financial management and extended runway .
  • ASCEND Cohort A showed a positive OS trend (median 12.68 vs 9.72 months) with four complete responses on certepetide vs zero on placebo; Cohort B accepted for oral at ESMO-GI, reinforcing clinical momentum .
  • First-line BOLSTER enrollment completed ~6 months ahead of plan, accelerating data timing to mid-2025; decisive cap of second-line enrollment (~20 patients) to expedite readout and conserve capital .

What Went Wrong

  • EPS slightly missed consensus by $0.02 (estimate $(0.53)* vs actual $(0.55)); limited sell-side coverage (one estimate) suggests thin expectations and potential volatility [GetEstimates] .
  • ASCEND Cohort A PFS primary endpoint did not reach statistical significance (median ~5.55 vs 5.52 months), complicating headline interpretation despite favorable OS trend .
  • Continued net losses and non-revenue operating model; revenue not reported for the quarter and dependency on external milestones/partnerships persists .

Financial Results

Income Statement and Balance Sheet (comparisons)

MetricQ1 2024Q4 2024Q1 2025
Total Operating Expenses ($USD Millions)$6.60 $5.95*$5.85
Net Loss ($USD Millions)$(5.40) $(4.61)*$(4.72)
Diluted EPS ($USD)$(0.65) $(0.55)*$(0.55)
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$—$31.25 $25.83
Total Assets ($USD Millions)$—$35.00 $28.98
Total Equity ($USD Millions)$—$29.32 $25.10

Values marked with * are retrieved from S&P Global.

Notes:

  • Q1 2025 operating expenses decreased 11.4% YoY, primarily due to lower CRO/site spending in BOLSTER and reduced CMC .
  • Cash runway extended to Q3 2026; no debt .

Operating Expense Breakdown (YoY)

MetricQ1 2024Q1 2025
Research & Development ($USD Millions)$3.24 $2.60
General & Administrative ($USD Millions)$3.36 $3.25

Estimates vs Actuals (Wall Street)

MetricQ1 2025
Primary EPS Consensus Mean ($USD)$(0.53)*
Primary EPS – # of Estimates1*
Diluted EPS Actual ($USD)$(0.55)
Revenue Consensus Mean ($USD Millions)$0.00*
Revenue – # of Estimates1*

Values marked with * are retrieved from S&P Global.

Margins

MetricQ1 2024Q1 2025
Net Income Margin %N/A (pre-revenue)*N/A (pre-revenue)*

Values marked with * are retrieved from S&P Global.

Segment breakdown: Not applicable (clinical-stage company without revenue segments).

KPIs:

  • Weighted average shares: 8.294M (Q1 2024) vs 8.602M (Q1 2025) .
  • Investment income (Q1): $0.589M (2024) vs $0.266M (2025) .
  • Other expense (Q1): $(0.187)M (2024) vs $(0.105)M (2025) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCompany-levelInto early 2026 (Q3 2024) Into Q3 2026 (Q1 2025) Raised / Extended
Cash RunwayCompany-levelInto Q2 2026 (Q4 2024) Into Q3 2026 (Q1 2025) Raised / Extended
ASCEND Cohort B TimingTrial“Coming months” (Q4 2024) Oral at ESMO-GI, July 2–5, 2025 Clarified / Scheduled
BOLSTER 1L CCA DataTrialMid-2025 (Q3 2024) Mid-2025 (Q1 2025) Maintained
Qilu China ProgramPartnerPhase 2 data “near future”; Phase 3 planned (Q4 2024/Q1 2025) Phase 3 planned; $10M milestone upon first patient Clarified milestone

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024 and Q4 2024)Current Period (Q1 2025)Trend
ASCEND (mPDAC)Cohort A OS favored certepetide; PFS not significant; Cohort B data expected mid-2025 Cohort B accepted for ESMO-GI oral; combined analyses to follow Visibility improving; focus shifting to Cohort B/combined OS
BOLSTER (CCA)1L completed enrollment early; 2L cohort added in 2024 1L topline mid-2025; 2L capped at ~20 to expedite data Execution accelerated; capital-efficient
Partnerships/ADC (Catalent SMARTag)Announced preclinical evaluation Confirmed tethering approach; covalent ADC payload strategy Broadening technology application
Imaging/Diagnostics (Kuva)Exclusive license; $1M upfront, ~ $20M milestones Considering imaging endpoints to accelerate PD readouts (FORTIFIDE alt strategy) Innovative trial design exploration
Regulatory StrategyFast Track, Orphan, Rare Pediatric designations highlighted Continued emphasis on OS endpoints; Project Optimus-consistent dosing evaluation in ASCEND Alignment with regulators maintained
Capital & RunwayInto early/Q2 2026 prior updates Into Q3 2026; no debt Strengthened runway
Manufacturing—Big pharma CMOs unlikely for small clinical quantities; capacity, cost constraints Practical CMC planning
Endometriosis (non-oncology)Preclinical data under review Early partnering conversations; focus remains on clinically ready assets Optionality, low near-term impact

Management Commentary

  • CEO: “Lisata maintains momentum into 2025… we now project having operational cash into the third quarter of 2026…” — underscoring disciplined spend and pipeline progress .
  • CFO: “Operating expenses totaled $5.8 million… net losses were $4.7 million… cash… approximately $25.8 million. [Funds] will support current operations into the third quarter of 2026.” — reiterating prudent capital management .
  • CMO: Detailed ASCEND/BOLSTER/CENDIFOX updates; Cohort A OS trend with 4 complete responses, Cohort B accepted for ESMO-GI; 1L CCA mid-2025; 2L capped for faster data .
  • CEO on cohort expectations: “Main answers [ASCEND]… interpretable after the July ESMO GI presentation” — a key near-term event .

Q&A Highlights

  • BOLSTER 2L cohort cap: Management expects comparable confidence in trend detection with ~20 patients; decision driven by speed and capital efficiency .
  • ASCEND timeline: Cohort B major endpoints (OS, PFS) at ESMO-GI; combined Arm A+B analyses to increase study power and interpretation thereafter .
  • Qilu China pathway: Moving quickly on innovation pathway; Phase 3 planned ahead of typical timelines to secure benefits; Lisata expects $10M milestone at first Phase 3 patient .
  • Manufacturing: Big pharma contract manufacturing for small clinical quantities unlikely due to train isolation, cleaning/requalification costs; would be uneconomic .
  • Tethered delivery: Catalent SMARTag ADC collaboration represents first major covalent tethering application for certepetide .

Estimates Context

  • Q1 2025 EPS: Actual $(0.55) vs S&P Global consensus $(0.53)*; modest miss of $0.02, driven by normal pre-revenue operating loss despite YoY opex reductions [GetEstimates] .
  • Q1 2025 Revenue: Consensus $0.00*; company did not report revenue for the quarter (consistent with pre-revenue clinical stage profile) .
  • Coverage remains thin (# of EPS estimates: 1*), so estimate dispersion is limited; upcoming clinical catalysts (ESMO-GI, BOLSTER) are more likely to drive revisions than cost deltas.

Values marked with * are retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term clinical catalyst: ASCEND Cohort B oral presentation at ESMO-GI (July 2–5) is the pivotal event likely to shape the Phase 3 path and partnership interest; expect OS/PFS disclosure akin to Cohort A detail .
  • Additional 2025 readouts: BOLSTER 1L mid-2025; iLSTA nearing full enrollment; CENDIFOX data anticipated in coming months, though timing is investigator-controlled .
  • Runway extension to Q3 2026 (no debt) reduces financing overhang into multiple readouts; capital discipline evident via 2L BOLSTER cap .
  • China optionality: Qilu’s acceleration and Phase 3 start could unlock a $10M milestone; watch for China data/readouts over 12–18 months .
  • Trial interpretation: ASCEND Cohort A PFS non-significance tempered by OS trend and complete responses; combined cohort analyses post-ESMO will be key for registrational design and partner dialogues .
  • Tactical positioning: Expect estimate revisions around EPS to be secondary; stock narrative likely driven by clinical signals and strategic updates (ADC tethering, imaging endpoints, regulatory alignment) .
  • Trading implications: July ESMO-GI is the central catalyst window; risk management should consider binary event dynamics in small-cap biotech with limited sell-side coverage and pre-revenue status [GetEstimates].