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LISATA THERAPEUTICS, INC. (LSTA)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 was operationally steady with a modest revenue contribution ($0.07M) from a Catalent research license and continued expense discipline; GAAP EPS of $(0.54) improved year over year and quarter over quarter as operating expenses fell 11% YoY to $4.94M .
  • Results outperformed S&P Global consensus: EPS beat by $0.11 (actual $(0.54) vs $(0.65)) and revenue beat by $0.07M (actual $0.07M vs $0.00M). Management reiterated a cash runway into 4Q 2026 with no debt, aided by prudent spend controls .
  • Strategic progress: FDA EOP2 agreement on the key elements of a global Phase 3 (1L mPDAC) and Phase 3 preparations underway; ASCEND Cohort B preliminary data at ESMO-GI showed a positive signal in PFS and ORR, with final combined A+B data anticipated later in 2025 .
  • Near-term catalysts likely to drive stock: combined ASCEND readout (2025), BOLSTER 1L CCA topline in 4Q 2025, iLSTA final readout in 1Q 2026, and potential $10M milestone upon Qilu Phase 3 start in China .

Values with asterisk (*) in this section are retrieved from S&P Global.

What Went Well and What Went Wrong

  • What Went Well

    • Clear estimate beats: EPS $(0.54) beat $(0.65)* and revenue $0.07M beat $0.00M*; expense reductions drove sequential and YoY improvement .
    • Clinical momentum: ASCEND Cohort B prelim data (two-dose regimen) trended favorably (mPFS 7.46 vs 4.65 months; HR 0.6, p=0.08) and higher ORR, reinforcing registration strategy; FDA agreed on Phase 3 design elements (OS primary, HR 0.75, 90% power) .
    • Balance sheet discipline: Cash/cash equivalents/marketable securities of $22.0M (6/30) with runway to 4Q 2026; no debt; management reiterated prudent spend and projected only a small NOL sale contribution in forecasts .

  • What Went Wrong

    • Minimal top-line scale: revenue remains de minimis ($0.07M) and non-recurring in nature (license fee); no product revenue, limiting margin analysis .
    • ASCEND Cohort A primary endpoint (6-month PFS) was not met; although OS and ORR trends were favorable, the initial academic design complicates interpretation vs. regulatory norms .
    • Funding path to Phase 3: initiation is gated by capital; while runway covers current programs, management indicated likely financing later this year or early next to fund large Phase 3 .

Financial Results

Q2 2025 vs prior periods (oldest → newest)

MetricQ2 2024Q1 2025Q2 2025
Revenue ($USD Millions)$0.00 $0.00 $0.07
R&D Expense ($USD Millions)$2.60 $2.60 $2.25
G&A Expense ($USD Millions)$2.92 $3.25 $2.69
Total Operating Expenses ($USD Millions)$5.52 $5.85 $4.94
Operating Loss ($USD Millions)$(5.52) $(5.85) $(4.87)
Net Loss ($USD Millions)$(5.04) $(4.72) $(4.66)
Diluted EPS ($)$(0.61) $(0.55) $(0.54)

Q2 2025 actual vs S&P Global consensus

MetricConsensusActual
Revenue ($USD Millions)$0.00*$0.07
Primary EPS ($)$(0.65)*$(0.54)

Values with asterisk (*) are retrieved from S&P Global.

Notes: Gross margin and EBIT/EBITDA margins are not meaningful given de minimis revenue and no reported COGS.

KPIs and balance sheet

KPIQ4 2024 (12/31/24)Q1 2025 (3/31/25)Q2 2025 (6/30/25)
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$31.25 $25.83 $21.97
Shares Outstanding (Millions)8.4 8.60 8.61
Debt$0 $0 $0
Options Outstanding (M)1.4 (12/31) 1.53 (3/31) 1.51 (6/30)
Warrants Outstanding (M) / WAEP1.5 / $40.52 1.5 / $40.52 1.5 / $40.52
Cash Runway2Q 2026 3Q 2026 4Q 2026

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayThrough2Q 2026 (FY24 call, 2/27) 4Q 2026 (Q2 PR, 8/7) Raised
ASCEND (A+B) final data2025“Final analysis after Cohort B in coming months” (Q1, 5/8) “Final data and key findings later in 2025” (Q2) Maintained (timing clarified)
BOLSTER 1L CCA topline2025Mid-2025 (FY24, 2/27) 4Q 2025 (Q1/Q2) Pushed later (from mid-2025 to 4Q 2025)
iLSTA final data1Q 2026Enrollment complete 1H 2025; no final data date (FY24/Q1) Final data 1Q 2026 New explicit timeline
Phase 3 (1L mPDAC)ProgramPreparation underway; EOP2 planned (FY24) FDA EOP2 held; agreement on design; initiation gated by capital (Q2) Advanced (design agreed)
Qilu China programNext stepPhase 2 enrollment complete; data “near future” (Q1) Plan to start Phase 3; $10M milestone upon 1st dose (timing TBD) Maintained (milestone reiterated)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’24 and Q1’25)Current Period (Q2’25)Trend
Regulatory/Phase 3 (mPDAC)Phase 3 prep underway; planning for EOP2, EMA interactions EOP2 held 5/21; FDA agreed on open-label design (OS primary, HR 0.75, 90% power), ~657 pts, ~183 sites; initiation gated by capital Positive progress
ASCEND clinical dataCohort A: PFS not significant; OS trend favors certepetide (mOS 12.68 vs 9.72); 4 CRs Cohort B prelim: mPFS 7.46 vs 4.65 (HR 0.6, p=0.08); ORR advantage; OS trend favors certepetideStrengthening signal
BOLSTER CCA1L enrollment finished early; topline shifted to 4Q 2025; 2L cohort capped ~20 pts for capital efficiency 1L topline 4Q 2025 reiterated; 2L capped remains for faster readout Schedule stabilized
Partnerships/AdjacenciesKuva license; Valo Tx collaboration; FORTIFIDE concept; Catalent ADC research license Catalent and GATC collaborations reiterated; Catalent assumes R&D cost; GATC AI platform exploration Expanded narrative
Capital/runwayRunway into 2Q 2026 (FY), 3Q 2026 (Q1) Runway to 4Q 2026; minimal NOL contribution assumed; financing probable later ’25/early ’26 for Phase 3 Improved runway
IP positionPortfolio through ~2040+ discussed New U.S. composition-of-matter patent to March 2040; strongest patent class Strengthened

Management Commentary

  • “We recently announced positive preliminary results from the ASCEND and iLSTA trials, and we anticipate a number of additional data events through the remainder of 2025 and into 2026.” — David J. Mazzo, CEO (Q2 PR) .
  • “Our continued rigorous financial management allows us to reaffirm our projection that available cash will fund current operations into the fourth quarter of 2026, including all active clinical studies through to their next data milestone.” — David J. Mazzo, CEO (Q2 PR) .
  • “Final data and key findings from both cohorts [ASCEND] are anticipated for later this year... we have agreement from the FDA on the fundamental aspects of an acceptable phase three protocol.” — Kristen Buck, CMO (Q2 call) .
  • “As of 06/30/2025, we had cash, cash equivalents and marketable securities of approximately 22,000,000... [we] believe available funds will support current operations into [2026].” — James Nisco, SVP Finance (Q2 call) .
  • “The latest patent [is] composition of matter… with the extension of that patent life out into the 2040s, we feel that the IP portfolio is now really ultimately secure.” — David J. Mazzo (Q2 call Q&A) .

Q&A Highlights

  • Phase 3 design: Open-label, ~650–900 patients depending on dosing arms, contemplating a continuous infusion arm alongside the two-dose regimen; 90% power at HR 0.75; design agreed with FDA at EOP2 (capital is the gating factor) .
  • Spending/runway: Expenses trending modestly lower as trials wrap; runway assumes only a small NOL sale contribution; financing likely later 2025/early 2026 to fund Phase 3 .
  • IP: Composition-of-matter patent extends to March 2040, viewed as robust foundational protection .
  • China path: Qilu aims to move fast on China Phase 3 under “innovation pathway,” with $10M milestone payable to Lisata upon first Phase 3 patient dosing .

Estimates Context

  • Q2 2025 EPS beat: $(0.54) actual vs $(0.65)* consensus; revenue beat: $0.07M actual vs $0.00M* consensus .
  • Prior quarters/YoY context: Q1 2025 EPS $(0.55) vs $(0.53); Q2 2024 EPS $(0.61) vs $(0.75) . Expense controls and non-recurring license revenue underpinned the beat in Q2 2025.

Values with asterisk (*) are retrieved from S&P Global.

Key Takeaways for Investors

  • Expense discipline continues to narrow losses; combined with modest BD revenue, this supported a clean EPS beat in Q2 2025 despite the pre-revenue profile .
  • Clinical risk/reward is improving: ASCEND Cohort B showed encouraging signals (mPFS/ORR) that, when combined with Cohort A OS trend, support Phase 3 progression in 1L mPDAC; final combined readout later in 2025 is the next pivotal catalyst .
  • Regulatory de-risking: FDA alignment on Phase 3 design (OS primary) reduces trial design uncertainty; capital raise timing is the primary gating item for initiation .
  • Multiple catalysts into 2026: ASCEND A+B, BOLSTER 1L CCA 4Q 2025, iLSTA 1Q 2026, plus potential $10M Qilu milestone on China Phase 3 start; these events are likely stock drivers .
  • IP strengthens strategic optionality: new U.S. composition-of-matter patent through March 2040 enhances partnering leverage and potential value capture .
  • Cash runway to 4Q 2026 with no debt offers time to deliver catalysts; however, expect financing aligned to Phase 3 start—monitor timing and terms .
  • Trading implication: Near- to medium-term share moves will likely hinge on ASCEND combined outcomes and clarity on Phase 3 funding/launch; positive ASCEND confirmation could be a significant rerating catalyst .

Additional Details and Cross-References

  • Non-GAAP: The company did not present non-GAAP metrics; all figures referenced are GAAP .
  • Cross-checks: CFO’s call remarks reconcile with press release financials (revenue $70k; OpEx $4.9M; net loss ~$4.7M; cash ~$22M) .
  • Trial design clarifications: ASCEND Cohort A (single-dose) did not improve 6-month PFS but favored OS/ORR; Cohort B (two-dose) showed stronger PFS/ORR signals; combined analysis expected later in 2025 .
  • Capital strategy: Management forecasts minimal NOL contribution and no assumed BD inflows beyond stated programs; financing is anticipated for Phase 3 .