Sign in

You're signed outSign in or to get full access.

LT

LISATA THERAPEUTICS, INC. (LSTA)·Q4 2024 Earnings Summary

Executive Summary

  • FY24 delivered disciplined OpEx control, a modest $1.0M revenue from the Kuva Labs license, and runway extended into Q2 2026 with no debt, while Q4 served as the platform for ASCEND Cohort A preliminary OS signal and multiple 2025 catalysts .
  • Operating expenses fell 8.9% YoY to $23.4M on lower ASCEND spend and reduced CMC/equity costs; net loss narrowed to $20.0M from $20.8M despite lower investment income .
  • Management emphasized that ASCEND’s full read (including Cohort B) is what matters for partners/Phase 3 planning; Cohort B disclosure targeted for ASCO/ESMO timing windows (late Q2–Q3 2025), and early iLSTA signals support synergy with immunotherapy .
  • Street reaction to Cohort A preliminary data was negative per Q&A discourse; management framed Cohort A as directional and Cohort B as the optimized dosing test that should govern ultimate interpretation and partnering discussions .

What Went Well and What Went Wrong

  • What Went Well

    • Prudent cost management: FY24 OpEx decreased 8.9% YoY (to $23.4M), with R&D down ~11% and G&A down ~6.9% as ASCEND enrollment concluded and equity/insurance/legal costs normalized .
    • Balance sheet and runway: $31.2M cash and investments at 12/31/24, no debt, and runway extended into Q2 2026, providing coverage through key data events .
    • Development momentum: ASCEND Cohort A showed a positive OS trend with four complete responses in the certepetide arm (vs. none on placebo); BOLSTER 1L CCA enrollment completed ahead of plan; CENDIFOX enrollment completed in Dec-2024; iLSTA interim suggested immunotherapy enhancement .

  • What Went Wrong

    • Mixed investor reception: Q&A acknowledged a “severe reaction” to ASCEND Cohort A preliminary disclosure; management attributed disappointment to expectations vs. an academic cohort not optimized for dosing, stressing that full data including Cohort B should drive conclusions .
    • Lower investment income: Investment income declined to $1.883M in FY24 from $2.724M in FY23, modestly offsetting operating loss improvements .
    • Limited quarterly disclosure granularity: No Q4 stand-alone P&L line breakout or revenue disaggregation was provided, constraining quarter-vs-estimate comparisons typical for commercial-stage peers .

Financial Results

Annual results

Metric ($USD thousands, except per share)FY 2023FY 2024
Revenue$0 $1,000
Research & Development$12,734 $11,334
General & Administrative$12,974 $12,075
Total Operating Expenses$25,708 $23,409
Operating Loss$(25,708) $(22,409)
Investment Income, net$2,724 $1,883
Other Expense, net$(186) $(257)
Net Loss$(20,840) $(19,985)
Basic & Diluted Loss/Share$(2.58) $(2.40)
Weighted Avg Shares (000s)8,073 8,329
Cash & Investments (EOY)$50,535 $31,245

Quarterly trends (operating metrics)

Metric ($USD thousands, except per share)Q1 2024Q2 2024Q3 2024
Research & Development$3,241 $2,601 $2,542
General & Administrative$3,360 $2,922 $2,794
Total Operating Expenses$6,601 $5,523 $5,336
Net Loss$(5,401) $(5,044) $(4,930)
Basic & Diluted Loss/Share$(0.65) $(0.61) $(0.59)
Cash & Investments (EOQ)$43,349 $38,262 $35,856

Balance sheet and liquidity (select points)

Metric ($USD thousands)Q1 2024Q2 2024Q3 2024FY 2024
Cash, Cash Equivalents & Marketable Securities$43,349 $38,262 $35,856 $31,245
Total Assets$48,240 $42,571 $38,199 $35,002
Total Liabilities$5,497 $4,576 $4,763 $5,685
Total Equity$42,743 $37,995 $33,436 $29,317

Notes:

  • No segment revenue or margin disclosures are applicable (pre-commercial stage) .
  • FY24 revenue reflects a $1.0M upfront from the Kuva Labs license; no quarterly revenue breakout provided .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayOperating runwayInto early 2026 Into Q2 2026 Raised (extended)
DebtCapital structure$0 debt (maintained) $0 debt (maintained) Maintained
ASCEND Cohort B timingData disclosureMid-2025 expectation (final analysis after Cohort B) “Coming months”; aiming for ASCO (late Q2) or ESMO (Q3) windows; sponsor controls timing Clarified window
BOLSTER 1L CCA toplineData timingMid-2025 Mid-2025 Maintained
CENDIFOX enrollmentOps milestoneEnroll complete expected by YE24 Enrollment completed Dec-2024 Achieved
Qilu Phase 2 mPDACChina programTrial initiated; ongoing Enrollment completed; data expected “in coming months” Advanced

No numerical guidance on revenue, margins, OpEx, OI&E, tax rate, or dividends was provided .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024, Q3 2024)Current Period (Q4 2024 call)Trend
ASCEND (mPDAC)Q2: Cohort A topline in Q4’24; full dataset mid-2025 . Q3: Cohort A to ASCO-GI Jan’25; Cohort B mid-2025 .Cohort A showed OS trend favoring certepetide incl. 4 CRs; Cohort B disclosure targeted for ASCO/ESMO windows; full trial governs Phase 3 plans .Progressing; emphasis on full dataset
BOLSTER (CCA)1L enrollment completed; mid-2025 topline; 2L added .1L on track mid-2025; ~30%+ of 2L enrolled; complete later 2025 .On schedule
CENDIFOXEnroll complete expected by YE24 .Enrollment completed Dec-2024; data expected in coming months .Milestone achieved
iLSTA (LA PDAC)Enrollment ongoing; 24/30 enrolled .27/30 enrolled; interim suggests immunotherapy enhancement (ASCO-GI) .Positive interim
GBM (temozolomide)Active; target 30 patients by 2H25 .Enrolling; 2H25 completion targeted .Steady
Qilu (China)Phase 2 placebo-controlled trial initiated .Enrollment completed; data expected in coming months .Advanced
FORTIFIDE (PDAC, 2L)Plan to start; ctDNA exploratory .Exploring imaging endpoints (via Kuva) to reach objectives faster/cheaper; details TBD .Strategy pivot under eval
Partnering/diagnostics—Kuva license ($1.0M upfront) and imaging strategy to potentially inform patient selection .Expanding optionality
Liquidity/runwayEarly 2026 .Into Q2 2026; no debt .Improved

Management Commentary

  • “We have advanced our development portfolio centered around our novel product candidate [certepetide]... We anticipate 2025 will be a data-rich year” (CEO) .
  • “ASCEND... Cohort A... showed a positive trend in overall survival, including four complete responses in the certepetide-treated group compared to none in placebo... Cohort B data are expected in the coming months” (CMO) .
  • On Cohort A investor reaction: management cited retail euphoria and design nuances; emphasized that dosing optimization and full data (incl. Cohort B) matter most for interpretation and partnering .
  • On FORTIFIDE: exploring imaging-based approaches with Kuva to derive pharmacodynamic insights faster and at lower cost vs. traditional PFS/OS endpoints (details not finalized) .

Q&A Highlights

  • ASCEND Cohort B timing: Targeting ASCO (late Q2) submission; if missed, ESMO in Q3. Final timing controlled by AGITG/CTC; aim is meaningful PFS/OS disclosure to inform Phase 3 design .
  • Street reaction: Management believes disappointment stemmed from expectations vs. an academic Cohort A design not optimized for dosing; reiterated program consistency and importance of full dataset .
  • Partner expectations: Pharma partners want full ASCEND results showing consistent efficacy/safety and effect size to size/power a Phase 3; no untoward safety signals to date .
  • Kuva/diagnostics: Intention is to identify tumors with increased permeability in presence of certepetide to inform patient selection clinically and eventually commercially .
  • FORTIFIDE alternative: Considering imaging endpoints to accelerate and de-risk pharmacodynamic learnings at lower cost .

Estimates Context

  • Wall Street (S&P Global) quarterly EPS/revenue consensus for Q4 2024 was unavailable at the time of analysis due to data access constraints. As a result, we cannot present vs-consensus comparisons for revenue/EPS this quarter [GetEstimates error].

KPIs (Program and Operating Metrics)

KPIQ2 2024Q3 2024Q4 2024 / Current
ASCEND Cohort A OS (median)——12.68 months certepetide vs 9.72 months placebo (prelim)
ASCEND Cohort A CRs——4 (certepetide) vs 0 (placebo)
BOLSTER 1L CCA enrollmentOngoing Completed Topline mid-2025
BOLSTER 2L CCA enrollmentPlanned Initiated >30% enrolled; complete later 2025
CENDIFOX enrollmentTarget YE24 —Completed Dec-2024
iLSTA enrollment—24/30 27/30
Qilu Phase 2 enrollmentInitiated —Completed; data “coming months”
Cash & investments$38.3M (6/30/24) $35.9M (9/30/24) $31.2M (12/31/24)

Key Takeaways for Investors

  • The investment case hinges on ASCEND’s full dataset (incl. Cohort B) to inform Phase 3 design and partnering; preliminary Cohort A signals are supportive but not dispositive .
  • Multiple 2025 catalysts (ASCEND Cohort B/full analysis, BOLSTER 1L topline, CENDIFOX readouts, Qilu P2 data) are funded by an extended runway into Q2 2026 with no debt, reducing near-term financing overhang risk .
  • Operational discipline continues to compress OpEx and narrow losses, supporting an extended cash runway without sacrificing clinical momentum .
  • Kuva diagnostics tie-in presents an avenue to accelerate pharmacodynamic insights (potentially FORTIFIDE alternatives) and refine patient selection, which could enhance clinical effect sizes and partner appeal -.
  • Watch communication cadence: because AGITG controls data disclosure, timing may be clustered around major congresses (ASCO/ESMO), adding event risk/opportunity in late Q2–Q3 2025 .
  • No non-GAAP adjustments were emphasized; results are GAAP-based, and quarterly revenue/EPS estimate comparisons are not meaningful at this stage (consensus unavailable and pre-revenue profile) .

Appendix: Additional Financial/Operational Notes

  • R&D reduction was driven primarily by ASCEND’s completed enrollment, lower CMC, and lower equity expense; G&A declines reflect prior-year severance normalization, lower equity, insurance, and legal, partially offset by one-off settlement/consulting .
  • NJ NOL sale brought $0.9M in non-dilutive cash in FY24 and cumulative $18.4M proceeds to date under the NJEDA program .
  • Annual Selected Financial Data and balance sheet details provided above reconcile to the 8-K tables furnished with the press release .