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- **Financial Stability**: Operating expenses down 17.3% YoY to $4.4 million; $19M cash runway to Q1 2027.
- **Clinical Momentum**: ASCEND trial Cohort A shows 4 complete responses; CENDIFOX pancreatic cancer resection rate 50%.
- **Strategic Expansion**: Catalent ADC partnership with preclinical success; GATC AI drug discovery alliance identifies 2026 candidates.
- **Phase III Challenges**: ASCEND Phase III funding requires pharma partners; stock underperformance despite positive data.


**【CEO Summary Section】**
- Announced strategic alliance with GATC Health to leverage AI for drug discovery and new indications.
- Entered nonexclusive license agreement with Catalent for certepetide use in ADCs, with preclinical data showing enhanced tumor targeting.
- Anticipated Phase III trial for ASCEND contingent on capital acquisition, with FDA-endorsed protocol finalized.
- GBM trial enrollment on track at 2/3 of target 30 patients, with completion expected in 2026.

**【CFO Financial Commentary】**
- Q3 2025 operating expenses: $4.4 million (17.3% YoY decrease), driven by R&D (-22.9%) and G&A (-12.1%) savings.
- Net loss of $4.2 million; cash balance $19 million, supporting operations into Q1 2027.
- Expense reductions achieved through optimized trial costs, consulting cuts, and staff reductions.

**【CMO Clinical Update】**
- ASCEND trial: Cohort A (95 pts) showed 4 complete responses vs. 0 in control; Cohort B (63 pts) demonstrated improved PFS and OS. Final data Q1 2026.
- CENDIFOX: 50% R0 resection rate in pancreatic cancer, 70% pathological response, 60% 2-year OS. Additional data pending.
- iLSTA: Combining certepetide with durvalumab in pancreatic cancer showed enhanced immune response; final data Q1 2026.
- Qilu Pharmaceutical's China trial for metastatic pancreatic cancer nearing completion, data expected 2026-2027.

**【Q&A Highlights】**
- CENDIFOX next data release timing uncertain due to investigator control; GBM trial enrollment 2/3 complete.
- Cash runway excludes Phase III costs; seeking pharma partners to share funding burden.
- Stock underperformance attributed to macro biotech headwinds and limited trading float.
- Exploring nonexclusive licensing to expand certepetide applications, with multiple candidates in pipeline.


Lisata Therapeutics, Inc.(LSTA)-20251107-2025 Q3 Earnings call transcript

- **Clinical Momentum**: ASCEND Cohort B shows improved PFS/ORR; BOLSTER 1st-line data Q4; Phase III protocol design finalized.
- **Financial Efficiency**: 10.6% YoY expense reduction; $22M cash runway to Q4 2026.
- **Strategic Partnerships**: Catalent ADC collaboration, GATC AI drug discovery, Qilu China expansion ($10M milestone).
- **IP Strength**: New certepetide patent extends exclusivity to 2040.
- **Growth Catalysts**: 650-900 pt Phase III trial; glioblastoma and non-oncology pipeline expansion.


**【CEO Opening Remarks】**
- Highlighted Q2 2025 milestones: research agreement with Catalent, strategic alliance with GATC Health, and encouraging preliminary results from ASCEND and iLSTA trials.
- Emphasized next 12 months as 'data-rich' with key clinical readouts expected.
- Noted prudent capital management and expense minimization.

**【CFO Financial Commentary】**
- **Revenue**: $70,000 (upfront license fee from Catalent), no revenue in Q2 2024.
- **Operating Expenses**: $4.9M (10.6% YoY decrease) driven by:
  - R&D: $2.3M (-13.4% YoY) due to reduced clinical costs.
  - G&A: $2.7M (-8.1% YoY) from staff reductions and cost controls.
- **Net Loss**: $4.7M (5.8% YoY improvement).
- **Cash Position**: $22M as of June 30, 2025, supporting operations into Q4 2026.

**【CMO Clinical Update】**
- **ASCEND Trial (mPDAC)**:
  - Cohort A (95 pts): 4 complete responses vs 0 placebo; PFS and OS data pending.
  - Cohort B (63 pts): 2-dose regimen shows improved PFS and ORR; final data Q4 2025.
  - FDA-endorsed Phase III protocol design with 650-900 pts.
- **BOLSTER Trial (cholangiocarcinoma)**:
  - 1st-line arm completed 6 months early; 2nd-line arm capped at 20 pts for faster analysis.
  - Data readout Q4 2025.
- **CENDIFOX Trial (pancreatic/colon cancer)**:
  - 50 pts treated across 3 cohorts; data pending.
- **Qilu Partnership (China)**:
 - 96 pts enrolled in Phase II; Phase III milestone ($10M) upon first patient dosing.
- **iLSTA Trial (pancreatic cancer + durvalumab)**:
  - Enrollment complete; interim data shows enhanced immunotherapy response; final data Q1 2026.
- **Glioblastoma Trial**:
  - 30 pts target; >50% enrolled; completion 2026.

**【Q&A Highlights】**
- **Phase III Protocol Design**: Open-label with 650-900 pts; evaluating continuous infusion vs 2-dose regimen.
- **Spending Outlook**: Modest decrease expected as trials complete; no new trials initiated without capital certainty.
- **Cash Runway**: Extended to Q4 2026; no new capital raises projected (excluding minor NJ NOL sale).
- **IP Milestone**: New certepetide patent (2040 expiry) covering composition, manufacturing, and oncology applications.
- **Regulatory Comparison**: FDA guidance clear; China regulatory dynamics not comparable due to local politics.


Lisata Therapeutics, Inc. (LSTA) Q2 2025 Earnings Call Transcript

- **Clinical Progress**: ASCEND Cohort A shows 4 complete responses; Bolster cholangiocarcinoma data mid-2025.
- **Financial Strength**: $25.8M cash runway; 11% YoY expense reduction.
- **Key Milestones**: Qilu Phase 2 data soon; Catalent ADC collaboration testing.

**【CEO Business Update】**
- **Strong momentum in 2025**: Despite small-cap healthcare challenges, Lisata maintains progress in Certepetide's clinical development for solid tumors.
- **Key trials advancing**: ASCEND (mPDAC) Cohort A shows positive OS trends; Bolster (cholangiocarcinoma) data expected mid-2025; CENDIFOX (pancreatic/colon cancer) data pending.
- **Global partnerships**: Qilu Pharmaceutical (China) Phase 2 data expected soon; Catalent collaboration for ADC payload testing.

**【CFO Financial Summary】**
- **Q1 2025 Operating Expenses**: $5.8M (down 11.4% YoY), driven by R&D cost reductions ($2.6M vs $3.2M) and G&A efficiency ($3.2M vs $3.4M).
- **Net Loss**: $4.7M (down 13% YoY), with $25.8M cash runway to Q3 2026.

**【CFO Clinical Updates】**
- **ASCEND Trial**: Cohort A (95 pts) shows 4 complete responses; Cohort B (63 pts) data due at ESMO GI 2025.
- **Bolster Trial**: 20 pts cap in 2nd-line cholangiocarcinoma to accelerate data; 1st-line data mid-2025.
- **Qilu Partnership**: Phase 2 data expected soon; $10M milestone upon Phase 3 start.

**【Q&A Highlights】**
- **Bolster Enrollment**: 20 pts vs 40 planned saves capital while maintaining statistical confidence.
- **Qilu Timeline**: Innovation pathway in China prioritizes speed over full Phase 2 analysis.
- **Manufacturing Strategy**: No big pharma manufacturing partnerships; focus on clinical supply contracts.
- **Endometriosis Pipeline**: Early mouse study success, but no clinical partners yet.

Lisata Therapeutics, Inc. (LSTA) Q1 2025 Earnings Conference Call Transcript

- **Clinical momentum**: Certepetide shows promising OS trends in pancreatic cancer, with Cohort B data expected Q2-Q3 2025. Expanded into 6+ cancer types and endometriosis.
- **Financial stability**: $31.2M cash runway to Q2 2026; 8.9% YoY expense reduction with prudent capital management.
- **Strategic partnerships**: Kuva imaging collaboration, AstraZeneca immunotherapy combo, and Valo oncolytic virus trials.
- **2025 catalysts**: ASCEND Phase 2 readout, BOLSTER cholangiocarcinoma data, and glioblastoma trial completion.

**【CEO Business Overview】**
- **Certepetide clinical progress**: Positive trends in overall survival (OS) and complete responses observed in Cohort A of the ASCEND trial for pancreatic cancer. Cohort B data expected in Q2-Q3 2025, with plans for Phase 3 if supportive.
- **Expanded pipeline**: Certepetide being evaluated in cholangiocarcinoma, glioblastoma, and endometriosis. Collaborations with Kuva Labs, AstraZeneca, and Valo Therapeutics to explore imaging, immunotherapy, and oncolytic virus combinations.
- **2025 outlook**: Data-rich year with key readouts from ASCEND, BOLSTER, CENDIFOX, and iLSTA trials.

**【CFO Financial Summary】**
- **Revenue**: $1 million (2024) from Kuva Labs collaboration, up from $0 in 2023.
- **Operating expenses**: $23.4 million (2024) vs. $25.7 million (2023), driven by reduced R&D and G&A costs.
- **Net loss**: $20 million (2024) vs. $20.8 million (2023), with $31.2 million cash as of Dec 31, 2024, supporting operations into Q2 2026.
- **Tax benefits**: $18.4 million from New Jersey program, with $19.6 million in tax credits sold.

**【CFO Clinical Pipeline Update】**
- **ASCEND trial**: Cohort A OS data showed 4 complete responses; Cohort B (2-dose regimen) enrollment complete, with final analysis pending.
- **BOLSTER trial**: Cholangiocarcinoma data expected mid-2025; second-line cohort enrollment ongoing.
- **CENDIFOX trial**: 50 patients treated across pancreatic, colon, and appendiceal cancers; tissue data pending.
- **iLSTA trial**: Early signals of immunotherapy enhancement in pancreatic cancer; enrollment near completion.
- **Glioblastoma trial**: 30-patient Phase 2a study underway in Eastern Europe.

**【Q&A Key Takeaways】**
- **ASCEND timing**: Cohort B data likely at ASCO (May 2025) or ESMO (Oct 2025), with Phase 3 contingent on results.
- **Market reaction**: Retail investors may have overreacted to Cohort A data, which showed early trends but not definitive results.
- **Kuva collaboration**: Potential for certepetide to enable personalized diagnostics and improve clinical trial efficiency.
- **Fortified trial alternatives**: Exploring imaging-based endpoints with Kuva to accelerate Phase 3 planning.
- **Partnership strategy**: Focusing on cost-effective trials with guaranteed funding, prioritizing pancreatic cancer Phase 3 readiness.

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