Lisata Therapeutics, Inc. · NASDAQ:LSTA

Lisata Therapeutics — Investor Presentation (October 2025)

70 slides from Lisata Therapeutics's investor presentation, Oct 14, 2025

  1. Slide 1: Corporate Presentation | October 14, 2025

    © L i s a t a T h e r a p e u t i c s , I n c . 2 0 2 5 . A l l r i g h t s r e s e r v e d . Targeted Therapy Delivered www.lisata.com Corporate Presentation | October 14, 2025 Nasdaq: LSTA Exhibit 99.1

  2. Slide 2: Forward-looking statements advisory

    2 Forward-looking statements advisory This presentation contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts,

  3. Slide 3: Lisata at a Glance

    Lisata at a Glance Company Overview 3

  4. Slide 4: Lisata Therapeutics Company Overview

    Lisata Therapeutics (Nasdaq: LSTA) Company Overview 4 OVERVIEW Clinical stage pharmaceutical company developing innovative therapies for the treatment of cancer and other serious diseases. MISSION To rapidly develop and commercialize innovative treatments that improve outcomes for patients with canc

  5. Slide 5: Key attributes

    Company Overview 5 Lisata Therapeutics (Nasdaq: LSTA): Key attributes Cash runway extending into 1Q 2027 with no debt Seasoned management with successful international drug development experience and expertise Platform technology validated by existing partnerships with potential for many others Mult

  6. Slide 6: Seasoned leadership with proven history of drug approvals worldwide

    Seasoned leadership with proven history of drug approvals worldwide 6 Kristen K. Buck, MD Executive Vice President of R&D and Chief Medical Officer Dr. Buck is a board certified and licensed physician with >20 years of strategic global drug development, drug/device safety/epidemiology, FDA, and clin

  7. Slide 7: Therapeutic Focus and Rationale

    Therapeutic Focus and Rationale 7

  8. Slide 8: Improved solid tumor treatment remains a vital, growing global need

    Improved solid tumor treatment remains a vital, growing global need Worldwide Cancer Incidence 2022 20 million new cases with 10 million deaths(1-2) 2050 35 million new cases with 18.5 million deaths(3) Solid tumors account for more than 90% of all diagnosed cancers Pancreatic Cancer Incidence By 20

  9. Slide 9: Current solid tumor treatments & patient outcomes are suboptimal

    Current solid tumor treatments & patient outcomes are suboptimal 9 Therapeutic Focus and Rationale Diagram source: Abizanda-Campo, S. et al, Microsyst Nanoeng 9, 154 (2023) Challenging tumor morphology and tumor microenvironment (TME) pose significant barriers to effective treatment and outcomes Tum

  10. Slide 10: Certepetide is designed to optimize solid tumor treatment

    Certepetide is designed to optimize solid tumor treatment 1 Sugahara, et al. Mol Cancer Ther; 14(1) January 2015; Hamilton, et al., J MolMed. April 2015; and Miyamura, et al., bioRxiv. May 2023. 2 Yuan, D., Duda, D., et al. CCA Foundation Conf. 2024 Poster. Enhancing the efficacy of standard therapy

  11. Slide 11: Certepetide possesses a strong Intellectual Property portfolio

    Certepetide possesses a strong Intellectual Property portfolio  Eight families, comprising 25 granted patents (6 U.S.), 26 pending patents, and two families in PCT phase  Orphan Drug Designations provides for 7 and 10 years of market exclusivity post-approval in the U.S. and EU, respectively  Com

  12. Slide 12: Partnerships

    Partnerships Noteworthy existing relationships and potential for many more 12

  13. Slide 13: Existing partnerships support certepetide's promise and broad applicability

    Existing partnerships support certepetide’s promise and broad applicability Partnerships 13 R&D alliances contribute resources with minimal commercial interest in certepetide  Australasian Gastro-Intestinal Trials Group - Clinical Trialists Consortium (Australia & New Zealand) and WARPNINE - Founda

  14. Slide 14: Certepetide Strong Scientific Foundation and Rationale

    14 Certepetide Strong Scientific Foundation and Rationale

  15. Slide 15: Certepetide mechanism of action: Unique, multi-step approach

    Certepetide mechanism of action: Unique, multi-step approach Certepetide - Strong Scientific Foundation and Rationale 15 1 Integrin binding 2 Proteolytic cleavage 3 Neuropilin-1 binding 4 Resulting tumor penetration Bound certepetide is proteolytically- cleaved in the tumor microenvironment (TME) re

  16. Slide 16: Certepetide/iRGD selectively promotes intratumoral penetration

    Certepetide/iRGD selectively promotes intratumoral penetration 1 Braun et al., Nature Mater. 2014. 2 Liu, Braun et al., Nature Comm. 2017. 3 Sugahara et al 2010. 16 Certepetide - Strong Scientific Foundation and Rationale Whole body imaging of mice with pancreatic ductal adenocarcinoma (arrow) dosed

  17. Slide 17: Broad applicability & activity of certepetide/iRGD consistently demonstrated

    Broad applicability & activity of certepetide/iRGD consistently demonstrated Sampling of >370 scientific publications showing improved survival 17 Certepetide - Strong Scientific Foundation and Rationale Breast cancer + Herceptin®Lung cancer + gemcitabine Zhang, et al., Plos One, 2015 Breast cancer

  18. Slide 18: Certepetide/iRGD improves immunotherapy efficacy in preclinical solid tumor models

    Certepetide/iRGD consistently improves immunotherapy efficacy in multiple preclinical solid tumor models 18 Solid Tumor Types  Intrahepatic cholangiocarcinoma  Pancreatic adenocarcinoma  Prostate cancer  Breast cancer  Non-Small Cell Lung Cancer  Gastric cancer  Hepatocellular carcinoma Precl

  19. Slide 19: Certepetide improves immunotherapy impact in cholangiocarcinoma

    Certepetide improves immunotherapy impact in cholangiocarcinoma 19 Certepetide - Strong Scientific Foundation and Rationale  Intrahepatic cholangiocarcinoma (ICC) has an immunosuppressive TME and a dense desmoplastic stroma with abnormal vasculature which together impede anti-cancer agent efficacy

  20. Slide 20: iRGD enhances selective tumor penetration of trastuzumab

    iRGD enhances selective tumor penetration of trastuzumab Mouse model injected with human BT474 breast tumors  Panel A shows greater staining for trastuzumab in breast cancer tissue with iRGD  Panel B shows remarkable selectivity for tumor tissue with iRGD  Panel C shows iRGD co-administered with

  21. Slide 21: Certepetide development strategy: A two-pillar approach

    Certepetide development strategy: A two-pillar approach 21 Certepetide - Strong Scientific Foundation and Rationale Pursue rapid global registration in mPDAC, initially combined with gemcitabine/nab-paclitaxel standard-of- care (SoC)  Positive ASCEND Phase 2b preliminary results  End-of-Phase 2 FD

  22. Slide 22: Positive Clinical Results Through Phase 2b

    Positive Clinical Results Through Phase 2b 22

  23. Slide 23: Certepetide improved survival in mPDAC in two Phase 1b/2a trials

    23 Positive Clinical Results Through Phase 2b Certepetide improved survival in mPDAC in two independent, multicenter Phase 1b/2a trials 1 Von Hoff D, et al., New England Journal of Medicine, 2013. 2 Dean A, et al., The Lancet Gastroenterology & Hepatology, 2022 3 QILU Pharmaceutical 0.5 2.5 4.5 6.5

  24. Slide 24: Certepetide demonstrated internal consistency in two Phase 1b/2a trials

    Certepetide demonstrated internal consistency in two Phase 1b/2a trials 1 Von Hoff D, et al., New England Journal of Medicine, 2013. 2 Dean A, et al., The Lancet Gastroenterology & Hepatology, 2022 3 QILU Pharmaceutical 24 Complete Response Partial Response Objective Response Rate Disease Control Ra

  25. Slide 25: ASCEND: Phase 2b study of certepetide in mPDAC

    ASCEND: Phase 2b study of certepetide in mPDAC  Sponsor: Australasian Gastro-Intestinal Trials Group (AGITG) and NHMRC Clinical Trials Centre of University of Sydney (Australia) • Lisata-funded, data contractually sponsor- controlled • Restricts initial public announcement of results to scientific

  26. Slide 26: ASCEND: Phase 2b study chronology

    ASCEND: Phase 2b study chronology 26 Positive Clinical Results Through Phase 2b Enrollment initiated in Cohort A May 2022 Lisata’s acquisition of Cend Therapeutics completed Sept 2022 Protocol amended to add Cohort B 1Q 2023 Enrollment in Cohort B initiated 2Q 2023 Cohort A enrollment completed 2Q 2

  27. Slide 27: ASCEND: Cohort A Progression-Free Survival data

    ASCEND: Cohort A Progression-Free Survival data Cohort A ONE IV PUSH OF CERTEPETIDE + SoC  Cohort A powered for 6-month PFS  No statistically significant improvement shown with certepetide  Data mature - 91% (86 out of 95 patients with Progressive Disease or Death) Cohort A: Progression-Free Surv

  28. Slide 28: ASCEND: Cohort A Overall Survival data

    ASCEND: Cohort A Overall Survival data Cohort A ONE IV PUSH OF CERTEPETIDE + SoC  Cohort A not powered for OS  Data mature - 76% (72 deaths out of 95)  mOS numerically favors certepetide (12.68 vs. 9.23 months); separation occurs at 7 months similar to NAPOLI-3  Cohort A ORR* data favors certepe

  29. Slide 29: ASCEND: Cohort B Progression-Free Survival data

    ASCEND: Cohort B Progression-Free Survival data Cohort B TWO IV PUSHES OF CERTEPETIDE 4 HOURS APART + SoC Cohort B: Progression-Free Survival (PFS) Data Treatment arm N Median PFS in months (95% CI) Certepetide 42 7.46 (5.52, 9.20) Standard of Care* 50 5.29 (3.84, 5.68)  Cohort B not powered for PF

  30. Slide 30: ASCEND: Cohort B Overall Survival data

    ASCEND: Cohort B Overall Survival data Cohort B TWO IV PUSHES OF CERTEPETIDE 4 HOURS APART + SoC  Cohort B not powered for OS  Data mature - 71% (45 deaths out of 63)  mOS favors certepetide (10.32 vs. 9.23 months)  Separation occurs at 7 months similar to NAPOLI-3 NALIRIFOX Phase 3 study data 

  31. Slide 31: Cohort B Time to Treatment Failure and Duration of Treatment

    Cohort B Time to Treatment Failure (TTF) and Duration of Treatment Cohort B TWO IV PUSHES OF CERTEPETIDE 4 HOURS APART + SoC Cohort B: Time To Treatment Failure and Treatment Duration Treatment arm Treatment Failures Median TTF months (95% CI) Certepetide 40/42 5.47 (4.47, 6.90) Standard of Care 20/

  32. Slide 32: ASCEND: Most Common Adverse Events (All Grades)

    ASCEND: Most Common Adverse Events (All Grades) Positive Clinical Results Through Phase 2b 32 Adverse Event (AE) Pooled Standard of Care n=49 Cohort A CERT n=65 Cohort B CERT n=42 Fatigue 29 (59.18%) 48 (73.85%) 34 (80.95%) Peripheral sensory neuropathy 22 (44.90%) 35 (53.85%) 24 (57.14%) Neutrophil

  33. Slide 33: Certepetide improves clinical outcomes in mPDAC with benign safety profile

    Certepetide improves clinical outcomes in mPDAC with benign safety profile Certepetide Clinical Data Summary to Date 33 Positive Clinical Results Through Phase 2b  Two Phase 1b/2a clinical trials (CEND1-001 in Australia and CEND1-201 in China) demonstrate that certepetide plus SoC chemotherapy impr

  34. Slide 34: Positive Early Clinical Results in Combination with I/O

    34 Positive Early Clinical Results in Combination with I/O

  35. Slide 35: iLSTA Phase 1b/2a study design with durvalumab

    Cohort 2 Gemcitabine + nab-paclitaxel + LSTA1 + Placebo durvalumab N=5 Cohort 1 Gemcitabine + nab-paclitaxel + Placebo LSTA1 + Placebo durvalumab N=5 Cohort 3 Gemcitabine + nab-paclitaxel + LSTA1 + durvalumab N=up to 20 12 weeks 8 weeks tumor burden assessments until 24 months or recurrence 12 month

  36. Slide 36: Preliminary Efficacy as of May 2025 – Best Overall Response Rate

    -18.4% -20.0% -35.0% -47.4% -53.8% -100.0% 0.0% -15.6% -17.5% -17.7% -20.0% -23.9% -28.0% -31.4% -32.9% -33.3% -41.8% -45.3% -46.2% -47.8% -65.2% -67.1% -69.2% -110% -100% -90% -80% -70% -60% -50% -40% -30% -20% -10% 0% 10% 20% 30% Patient 010 Patient 017 Patient 031 Patient 029 Patient 033 Patient

  37. Slide 37: Remarkable evidence of certepetide activity in other solid tumors

    Remarkable evidence of certepetide activity in other solid tumors Certepetide potentiated a complete response in metastatic gastroesophageal adenocarcinoma (mGEAC) FDG-PET* scan June 2022 FDG-PET scan Sept. 2022 Reduction in FDG activity demonstrated(1)  53-year-old male with mGEAC with significant

  38. Slide 38: Attractive Commercial Opportunity

    Attractive Commercial Opportunity 38

  39. Slide 39: Certepetide can be used throughout the mPDAC treatment paradigm

    Patient with mPDAC Diagnosis Poor Patient Functional Status Good Patient Functional Status Gemcitabine + Nab-paclitaxel Gemcitabine + Nab-paclitaxel First-Line (1L) First-Line (1L) Disease Progression FOLFIRINOX or NALIRIFOX FOLFIRINOX or FOLFIRI or FOLFOX or NALIRIFOX Second-Line (2L) Second-Line (

  40. Slide 40: Certepetide's broad value proposition beyond mPDAC

    Certepetide’s broad value proposition beyond mPDAC Breadth of Applicability Certepetide’s Commercial Prospects Oncologic applications:  Locally advanced PDAC - a population recognized as non- responsive to checkpoint inhibition - Improved clinical outcomes demonstrated  Metastatic gastroesophageal

  41. Slide 41: Certepetide special regulatory designations and benefits

    Certepetide special regulatory designations and benefits 41 FDA Fast Track Designation • Pancreatic cancer (FDA)  Eligible for Accelerated Approval, Priority Review and Rolling Review  Provides for program-specific guidance from and frequent communication with FDA Orphan Drug Designations • Pancre

  42. Slide 42: Poised for Global Phase 3 Initiation

    Poised for Global Phase 3 Initiation 42

  43. Slide 43: Requisite clinical development steps completed in preparation for Phase 3

    Requisite clinical development steps completed in preparation for Phase 3 trial Full NDA-ready preclinical toxicology package Phase 1 dose ranging study in 1L mPDAC  No DLTs observed; safety profile consistent with co-administered SoC  Certepetide improved all efficacy endpoints compared to SoC Se

  44. Slide 44: mPDAC Phase 3 study design agreed with FDA

    mPDAC Phase 3 study design agreed with FDA  Global Phase 3, open-label, randomized clinical trial evaluating the efficacy and safety of certepetide in combination with standard of care (gemcitabine and nab-paclitaxel) vs. standard of care alone in patients with 1L mPDAC  N=657 patients (+/- 50 dep

  45. Slide 45: Certepetide Development Portfolio

    45 Certepetide Development Portfolio

  46. Slide 46: Certepetide capital efficient clinical development plan

    Certepetide capital efficient clinical development plan Certepetide – Clinical / Regulatory Development Portfolio 46 Sponsor(s) Indication Description Current Phase Phase 1 Phase 2 Phase 3 AGITG/Lisata First-line mPDAC  ASCEND: Phase 2b, placebo-controlled trial (N=158)  Gemcitabine/nab-paclitaxel

  47. Slide 47: Clinical Development Milestones

    Clinical Development Milestones 47

  48. Slide 48: A wealth of key certepetide clinical milestones

    A wealth of key certepetide clinical milestones Clinical Development Milestones 48 1Q 2024 2Q 2024 3Q 2024 4Q 2024 1Q 2025 2Q 2025 3Q 2025 4Q 2025 1Q 2026 2Q 2026 ASCEND [AUS, NZ] First-line mPDAC BOLSTER [USA] First- and second-line CCA CENDIFOX [USA] Pancreatic, Colon and Appendiceal Cancers iLSTA

  49. Slide 49: Financial Summary

    49 Financial Summary

  50. Slide 50: Capital projected to fund all clinical programs to data

    Capital projected to fund all clinical programs to data Financial Summary 50 $22.0M Cash & Investments As of 6/30/2025 $0 Debt 1Q 2027 Projected Cash Runway into Common Shares Outstanding (6/30/2025): 8.6 million shares Options Outstanding (6/30/2025): Exercise Price: $0.02 - $4.22 = 1,293,100 share

  51. Slide 51: Key factors supporting investment in Lisata Therapeutics

    * As of 6/30/2025; includes investments Key factors supporting investment in Lisata Therapeutics 51 Strong Investment Rationale PEOPLE Seasoned management with successful international drug development experience and expertise INTELLECTUAL PROPERTY Proprietary field- leading technology with global I

  52. Slide 52: Investor Relations Contact

    © L i s a t a T h e r a p e u t i c s , I n c . 2 0 2 5 . A l l r i g h t s r e s e r v e d . Investor Relations Contact: John D. Menditto VP, IR & Corporate Communications Tel: (908) 842-0084 | Email: jmenditto@lisata.com Nasdaq: LSTA | www.lisata.com Targeted Therapy Delivered

  53. Slide 53: Appendix

    Appendix 53

  54. Slide 54: Certepetide capital efficient clinical development plan

    Appendix Certepetide capital efficient clinical development plan Development Partner(s) [Development Venue] Indication and Trial Product/Comparator Stage of Development Strategic Rationale Lisata/AGITG [Australia/New Zealand] First-line mPDAC; Gemcitabine/nab-paclitaxel with certepetide or placebo P

  55. Slide 55: ASCEND: Phase 2b, blinded, randomized trial in mPDAC

    ASCEND: Phase 2b, blinded, randomized trial in mPDAC 55 Appendix Sponsor/Partner  Australasian Gastro-Intestinal Trials Group (AGITG) in collaboration with the NHMRC Clinical Trials Centre at the University of Sydney  Lisata funded (LSTA eligible for ~43% rebate on all qualified R&D expenses in AU

  56. Slide 56: ASCEND trial design: Cohorts A and B

    R INTERVENTION Arm (N=63) • Nab-paclitaxel 125 mg/m2 IV infusion • ONE IV push of Certepetide 3.2 mg/kg • Gemcitabine 1000 mg/m2 IV infusion Treatment on days 1, 8, 15 every 28 days CONTROL Arm (N=29) • Nab-paclitaxel 125 mg/m2 IV • Matching certepetide Placebo IV • Gemcitabine 1000 mg/m2 IV Treatme

  57. Slide 57: Phase 1b/2a open-label trial in mPDAC in China (CEND1-201)

    Sponsor/Partner  Qilu Pharmaceutical (funds all development in China) Objective  Evaluate safety, pharmacokinetics and preliminary efficacy of certepetide added to SoC in Chinese patients with mPDAC Design  Phase 1b/2a open-label study in advanced mPDAC patients of Chinese ethnicity testing SoC c

  58. Slide 58: Qilu Phase 1b/2a trial design

    7 Day Safety Evaluation Certepetide 1.6 mg/kg + nab-pac* + gem Days 1, 8, and 15 every 28 days Confirm Eligibility Informed Consent Extension Stage mPDAC 1.6 mg/kg certepetide Day 1 Phase 1b/2a study evaluating the safety, pharmacokinetics, and preliminary efficacy of certepetide for injection in Ch

  59. Slide 59: CENDIFOX Phase 1b/2a trial with neoadjuvant FOLFIRINOX

    Sponsor/Partner  University of Kansas Medical Center (Investigator initiated trial in U.S.)  KUCC funded; Lisata provides certepetide Objective  Evaluate the safety and therapeutic effect of certepetide in combination with neoadjuvant FOLFIRINOX- based therapies and an EGFR inhibitor for the trea

  60. Slide 60: CENDIFOX Phase 1b/2a trial design

    Surgery COHORT 1 Resectable and borderline resectable PDAC Key Objectives: • Pathological response • Immune response pre- & post- treatment • PFS, OS FOLFIRINOX X 3 Cycles (± Panitumumab if RAS/BRAF wildtype - Cohorts 2, 3) Tissue immune profiling Biopsy if archival tissue not available COHORT 2 Col

  61. Slide 61: BOLSTER: Phase 2 blinded, randomized trial in cholangiocarcinoma

    Sponsor/Partner  Lisata (U.S.) Objective  Evaluate the preliminary efficacy, safety and tolerability of certepetide in combination with standards of care in subjects with first- and second-line cholangiocarcinoma Design  Phase 2 randomized, double-blind, placebo-controlled, proof-of-concept trial

  62. Slide 62: BOLSTER Phase 2a trial design

    Dosed on Days 1, 8 every 21 days X 8 cycles Disease Progression Response rates Safety Confirm Eligibility Informed Consent Survival Analysis Certepetide + cisplatin/gemcitabine/durvalumab 72-hour run-in without SoC 1st line Cholangiocarcinoma (CCA) Placebo + cisplatin/gemcitabine/durvalumab R Phase

  63. Slide 63: Phase 2 double-blind, placebo-controlled trial in mPDAC in China

    Sponsor/Partner  Qilu Pharmaceutical (funds all development in China) Objective  Further evaluate safety and therapeutic efficacy of certepetide when added to SoC in Chinese patients with locally advanced unresectable mPDAC Design  Phase 2b, double-blind, placebo-controlled, randomized study eval

  64. Slide 64: Qilu Phase 2b trial design

    Days 1, 8, 15 and every 28 days Disease Progression Response rates PFS Safety Gemcitabine + Qilu produced nab-paclitaxel + certepetide 3.2 mg/kg Confirm Eligibility Informed Consent 1:1 Survival AnalysismPDAC R Gemcitabine + Qilu produced nab-paclitaxel + placebo N=48 N=48 Phase 2b, double-blind, pl

  65. Slide 65: iLSTA Phase 1b/2a trial in locally advanced PDAC

    Sponsor/Partner  WARPNINE, Inc. (registered charity in Australia) is funding trial  Lisata providing study drug Objective  Evaluate safety and therapeutic effect of LSTA1 in combination with IO & Chemo in locally advanced non-resectable pancreatic ductal adenocarcinoma (PDAC); determine if inoper

  66. Slide 66: iLSTA trial design

    Cohort 2 Gemcitabine + nab-paclitaxel + LSTA1 + Placebo durvalumab N=5 Cohort 1 Gemcitabine + nab-paclitaxel + Placebo LSTA1 + Placebo durvalumab N=5 Cohort 3 Gemcitabine + nab-paclitaxel + LSTA1 + durvalumab N=up to 20 12 weeks 8 weeks tumor burden assessments until 24 months or recurrence 12 month

  67. Slide 67: Preliminary iLSTA trial results poster at 2025 ASCO-GI Symposium

    Preliminary iLSTA trial results poster at 2025 ASCO-GI Symposium Appendix 67An abstract with a detailed summary of the poster presentation is also available on the ASCO GI website: https://meetings.asco.org/abstracts-presentations/241611

  68. Slide 68: Updated preliminary iLSTA trial results poster at 2025 ESMO-GI

    Updated preliminary iLSTA trial results poster at 2025 ESMO-GI 68 Appendix

  69. Slide 69: Phase 2a trial of certepetide with SoC in first-line GBM

    Sponsor/Partner  Tartu University Hospital (Investigator initiated trial in Estonia, Latvia and Lithuania)  Lisata providing study drug and funding trial Objective  Evaluate safety, tolerability, and therapeutic effect of certepetide in combination with standard-of-care (temozolomide) in patients

  70. Slide 70: GBM Phase 2a trial design

    Days 1, 2, 3, 4, 5 and every 28 days for 6 cycles Disease Progression Response rates Safety Temodar® + certepetideConfirm Eligibility Informed Consent 2:1 Survival Analysis 72-hour Run-in without SoC Newly Diagnosed GBM R Temodar® + certepetide matching placebo N=18 N=9 Phase 2a proof-of-concept dou

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