LISATA THERAPEUTICS, INC. (LSTA)·Q3 2025 Earnings Summary

Executive Summary

• Q3 2025 delivered disciplined expense management with operating expenses down 17.3% YoY to $4.4M and net loss improving to $4.2M; diluted EPS of $0.49 loss beat the Wall Street consensus loss of $0.535 (beat by $0.045). Cash runway extended into Q1 2027 with no debt, lowering near-term financing risk . EPS/Revenue estimates from S&P Global.*
• Clinical catalysts strengthened: pooled ASCEND Phase 2b data reinforced certepetide signals in mPDAC; Catalent advanced to a global non-exclusive license to use certepetide in SMARTag ADCs; and a strategic AI alliance with GATC Health was formed .
• Guidance and timelines updated: ASCEND final data now expected in Q1 2026 (previously “later this year”), BOLSTER 1L CCA topline maintained for Q4 2025, and iLSTA final data maintained for Q1 2026 .
• Management emphasized readiness for a global Phase 3 in mPDAC (protocol agreed with FDA) while pursuing partnering to fund the program, highlighting non-dilutive milestone potential (e.g., Qilu Phase 3 in China) .
• Potential stock-reaction catalysts: near-term data readouts (BOLSTER 1L in Q4 2025), ASCEND final analysis in Q1 2026, ADC preclinical readouts from Catalent, and partnering milestones (including potential Qilu Phase 3 trigger) .

What Went Well and What Went Wrong

What Went Well

• “We now project that our available cash will fund current operations into the first quarter of 2027,” reflecting tight OpEx control and prudent capital management .
• Clinical momentum: ASCEND Cohort B showed mPFS 7.46 months vs 5.29 months in placebo (HR 0.61, p=0.09) and stronger ORR including a complete response; pooled data at ESMO suggested no increase in AEs vs SoC .
• Strategic BD: Catalent global license for certepetide as SMARTag ADC payloads and alliance with GATC Health’s AI platform broaden non-dilutive upside and modality breadth .

What Went Wrong

• Timeline slip: ASCEND final data moved from “later this year” (Q2 view) to Q1 2026, modestly delaying the Phase 3 decision catalyst .
• Zero quarterly revenue and continued losses highlight dependence on external funding/partners; net loss was $4.2M, diluted EPS loss $0.49 in Q3 2025 .
• Macro headwinds and small-cap biotech sentiment dampened stock response despite data; management cited limited float and lack of buyers as challenges .

Financial Results

P&L and EPS vs prior periods

• YoY: OpEx -$922k (-17.3%), net loss +$681k improvement, EPS loss improved by $0.10 .
• QoQ: OpEx -$524k, net loss +$410k improvement, EPS loss improved by $0.05 vs Q2 .

Operating expense breakdown

Liquidity and capital

Estimates vs Actuals (Q3 2025)

Values retrieved from S&P Global.*

Segment breakdown

KPIs

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “Overall, it was a productive and positive quarter marked by our continued vigilance in managing expenses. As a result, we now project that our available cash will fund current operations into the first quarter of 2027.” — David J. Mazzo, CEO .
• “Compelling positive data from Catalent’s preclinical study… showed not only improved ADC efficacy but broadened distribution of the cytotoxic payload within the tumor.” — Portfolio update .
• “We also entered into a strategic alliance with GATC Health… to optimize and accelerate drug discovery and development, including analyzing certepetide for new indications.” .
• On macro/stock dynamics: “The problem is a confluence of negative forces… many of our shareholders treat their holdings… as venture capitalists… with a limited float like we have… a very small number of trades could make the market.” — CEO Q&A .
• Phase 3 funding strategy: pursue licensees/partners to bear a substantial portion of funding to avoid excessive dilution; internal readiness ongoing (CMC, protocol alignment, CRO dialogues) .

Q&A Highlights

• Catalysts and timelines: ASCEND final analysis in Q1 2026; GBM trial ~two-thirds enrolled; CENDIFOX data timing controlled by investigator (KU Cancer Center) .
• Runway and burn: Runway to Q1 2027 covers operating and ongoing trials; burn could rise intentionally with more studies, prioritizing non-dilutive sources (licensing, milestones) before capital raises .
• Partnering strategy: Building on non-exclusive licenses (e.g., Catalent) to add further licensees; handled internally without external consultants; structure likely indicates disease/drug-specific non-exclusives .
• Phase 3 funding approach: Seek pharma partners to share/lead funding; internal steps completed to be Phase 3-ready across protocol, CMC, and global regulatory discussions .

Estimates Context

• Q3 2025 EPS of $(0.49) beat the S&P Global consensus loss of $(0.535) by $0.045; revenue was inline at $0, reflecting a clinical-stage profile without commercial revenue streams. Values retrieved from S&P Global.*
• With expenses trending lower and investment income modestly declining QoQ, near-term EPS estimates may need mild upward revision (less negative) if OpEx discipline persists; however, Phase 3 initiation would increase spend, tempering EPS improvement potential .

Key Takeaways for Investors

• EPS beat with tightened OpEx and extended runway to Q1 2027 reduces near-term financing risk; watch for non-dilutive capital sources (license milestones) and potential partner funding .
• Near-term catalysts: BOLSTER 1L CCA topline in Q4 2025; Catalent ADC preclinical updates; ASCEND final data in Q1 2026; iLSTA final data in Q1 2026 .
• Phase 3 readiness in mPDAC is high (FDA agreement), but initiation is contingent on capital/partnering—track BD updates and any China Phase 3 initiation by Qilu (potential $10M milestone) .
• Clinical breadth strengthens certainty of the platform: mPDAC (ASCEND), CCA (BOLSTER), LA PDAC with IO (iLSTA), and GBM (Phase 2a), supporting a diversified catalyst path .
• Macro headwinds and limited float may continue to depress equity response; focus on data cadence and BD milestones that can re-rate sentiment .
• If Phase 3 starts, expect higher quarterly burn and likely financing; watch for partner-led designs or regionally structured funding to limit dilution .
• No revenue segments yet; performance hinges on trial outcomes and BD traction—risk/reward skewed to execution of upcoming catalysts and Phase 3 path .

Notes: EPS/Revenue estimates and consensus figures marked with * are Values retrieved from S&P Global.