Lisata Therapeutics, Inc. · NASDAQ:LSTA

Lisata Therapeutics — Q2 2025 Earnings Presentation

71 slides from Lisata Therapeutics's earnings presentation, Aug 7, 2025

  1. Slide 1: Targeted Therapy Delivered

    Targeted Therapy Delivered Corporate Presentation | August 7, 2025 Nasdaq: LSTA www.lisata.com © Lisata Therapeutics, Inc. 2025. All rights reserved.

  2. Slide 2: Forward-looking statements advisory

    Disclosure 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 historica

  3. Slide 3: Lisata at a Glance

    Lisata at a Glance Company Overview 3

  4. Slide 4: Lisata Therapeutics Overview and Mission

    Company Overview Lisata Therapeutics (Nasdaq: LSTA) OVERVIEW MISSION Clinical-stage therapeutics To safely enhance the treatment company rapidly developing a benefits of existing and emerging novel solid tumor targeting therapies for solid tumors and similar and penetration technology diseases utili

  5. Slide 5: Lisata Therapeutics: Key attributes

    Company Overview Lisata Therapeutics (Nasdaq: LSTA): Key attributes Seasoned Platform technology management with Proprietary field- Multiple product and validated by existing successful leading technology business milestones partnerships with international drug with global IP projected over the pote

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

    Company Overview Seasoned leadership with proven history of drug approvals worldwide David J. Mazzo, PhD Kristen K. Buck, MD President and Chief Executive Officer, Member of the Board of Directors Executive Vice President of R&D and Chief Medical Officer With >40 years of experience, Dr. Mazzo is a

  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

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

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

    Therapeutic Focus and Rationale Current solid tumor treatments & patient outcomes are suboptimal Challenging tumor morphology and tumor microenvironment (TME) pose significant barriers to effective treatment and outcomes Tumor stroma acts as a physical barrier to anti-cancer agents An immunosuppress

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

    Therapeutic Focus and Rationale Certepetide is designed to optimize solid tumor treatment Certepetide: a proprietary internalizing RGD* (iRGD) cyclic peptide adjuvant with tumor specific targeting & penetration activity and tumor microenvironment modifying properties  Converts tumor stroma from a b

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

    Therapeutic Focus and Rationale Certepetide possesses a strong Intellectual Property portfolio  Eight families, comprising 11 granted patents (6 U.S.), 19 pending patents, one family in its PCT phase, and two in provisional status  Orphan Drug Designations bring 7 and 10 years of market exclusivit

  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

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

  14. Slide 14: Certepetide: Strong Scientific Foundation and Rationale

    Certepetide Strong Scientific Foundation and Rationale 14

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

    Certepetide - Strong Scientific Foundation and Rationale Certepetide mechanism of action: Unique, multi-step approach 4 Resulting tumor penetration CendR pathway actuation triggers encapsulation 1 Integrin binding 2 Proteolytic cleavage 3 Neuropilin-1 binding of circulating co-administered anti-canc

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

    Certepetide - Strong Scientific Foundation and Rationale Certepetide/iRGD selectively promotes intratumoral penetration Whole body imaging of mice with pancreatic ductal adenocarcinoma (arrow) dosed with Fluorescent Quantum When co-administered with iRGD, nab- Dots (FQDs) with and without certepetid

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

    Certepetide - Strong Scientific Foundation and Rationale Broad applicability & activity of certepetide/iRGD consistently demonstrated Sampling of >370 scientific publications showing improved survival Lung cancer + gemcitabine Breast cancer + nanoparticle nab-paclitaxel Breast cancer + Herceptin® Su

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

    Certepetide - Strong Scientific Foundation Certepetide/iRGD consistently improves immunotherapy efficacy in multiple preclinical solid tumor models Solid Tumor Types Preclinical Observations  Intrahepatic cholangiocarcinoma  Improved overall survival  Pancreatic adenocarcinoma  Reduced tumor siz

  19. Slide 19: Certepetide improves immunotherapy impact in cholangiocarcinoma

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

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

    Certepetide - Strong Scientific Foundation and Rationale iRGD enhances selective tumor penetration of trastuzumab Mouse model injected with human BT474 breast tumors Trastuzumab is a monoclonal Ab that inhibits HER2 A B C Trastuzumab Trastuzumab + iRGD Tumor Liver Spleen Pancreas Heart Lung Kidney B

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

    Certepetide - Strong Scientific Foundation and Rationale Certepetide development strategy: A two-pillar approach Pursue rapid global registration in mPDAC, initially combined with Demonstrate certepetide effectiveness gemcitabine/nab-paclitaxel standard-of- when combined with a variety of other care

  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

    Positive Clinical Results Through Phase 2b Certepetide improved survival in mPDAC in two independent, multicenter Phase 1b/2a trials 12.5 13.2 months 10.5 55% improvement Von Hoff 2013 Phase 3 11.1 Gemcitabine + Nab-paclitaxel(1) months Registration study establishing gemcitabine 8.5 + nab-paclitaxe

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

    Positive Clinical Results Through Phase 2b Certepetide demonstrated internal consistency in two Phase 1b/2a trials Von Hoff 2013 Phase 3 Gemcitabine + Nab-paclitaxel(1) Registration study establishing gemcitabine + 9.7 nab-paclitaxel as SoC in mPDAC 96% 91% mo CEND1-001 Australia 87% Gemcitabine + N

  25. Slide 25: Remarkable evidence of certepetide activity in other solid tumors

    Positive Clinical Results Through Phase 2b Remarkable evidence of certepetide activity in other solid tumors Certepetide potentiated a complete response in metastatic gastroesophageal adenocarcinoma (mGEAC)  53-year-old male with mGEAC with significant FDG-PET* scan June 2022 FDG-PET scan Sept. 202

  26. Slide 26: ASCEND: Phase 2b study of certepetide in mPDAC

    Positive Clinical Results Through Phase 2b ASCEND: Phase 2b study of certepetide in mPDAC Investigator initiated trial inherited through Lisata amended protocol to ensure trial data will acquisition of Cend Therapeutics support global registration strategy  Sponsor: Australasian Gastro-Intestinal T

  27. Slide 27: ASCEND: Phase 2b study chronology

    Positive Clinical Results Through Phase 2b ASCEND: Phase 2b study chronology Enrollment initiated Protocol amended Cohort A enrollment Cohort A initial Cohort B initial data in Cohort A to add Cohort B completed data presented at presented at ESMO-GI May 2022 1Q 2023 2Q 2023 ASCO-GI Jan 2025 July 20

  28. Slide 28: ASCEND: Preliminary Cohort A Progression-Free Survival data

    Positive Clinical Results Through Phase 2b ASCEND: Preliminary Cohort A Progression-Free Survival data Cohort A: Progression-Free Survival (PFS) Data Data cut-off 4 November 2024 Standard of Care Certepetide + SoC Cohort A ONE IV PUSH OF CERTEPETIDE + SoC median  Cohort A powered for 6-month PFS Mo

  29. Slide 29: ASCEND: Preliminary Cohort A Overall Survival data

    Positive Clinical Results Through Phase 2b ASCEND: Preliminary Cohort A Overall Survival data Cohort A: Overall Survival (OS) Data Data cut-off 4 November 2024 Standard of Care Certepetide + SoC Cohort A ONE IV PUSH OF CERTEPETIDE + SoC median  Cohort A not powered for OS  Data mature - 76% (72 de

  30. Slide 30: ASCEND: Preliminary Cohort B Progression-Free Survival data

    Positive Clinical Results Through Phase 2b ASCEND: Preliminary Cohort B Progression-Free Survival data Cohort B: Progression-Free Survival (PFS) Data Data cut-off 30 December 2024 Cohort B TWO IV PUSHES OF CERTEPETIDE 4 HOURS APART + SoC  Cohort B not powered for PFS  Data mature  Despite not bei

  31. Slide 31: ASCEND: Preliminary Cohort B Overall Survival data

    Positive Clinical Results Through Phase 2b ASCEND: Preliminary Cohort B Overall Survival data Cohort B: Overall Survival (OS) Data Data cut-off 30 December 2024 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 fav

  32. Slide 32: Cohort B Time to Treatment Failure and Duration of Treatment

    Positive Clinical Results Through Phase 2b Cohort B Time to Treatment Failure (TTF) and Duration of Treatment Data cut-off 30 December 2024 Cohort B: Time To Treatment Failure and Treatment Duration Cohort B TWO IV PUSHES OF CERTEPETIDE 4 HOURS APART + SoC  TTF and Treatment duration favor certepet

  33. Slide 33: ASCEND: Phase 2b study of certepetide in mPDAC in summary

    Positive Clinical Results Through Phase 2b ASCEND: Phase 2 study of certepetide in mPDAC in summary Certepetide improves clinical outcomes in mPDAC with benign safety profile  mOS in Cohort A numerically favored certepetide as did ORR (4 Complete Responses in the certepetide + SoC group and 0 in th

  34. Slide 34: Certepetide Clinical Data Summary to Date

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

  35. Slide 35: Positive Early Clinical Results in Combination with I/O

    Positive Early Clinical Results in Combination with I/O 35

  36. Slide 36: iLSTA: Phase 1b/2a trial in locally advanced PDAC with chemo & IO

    Positive Early Clinical Results in Combination with I/O iLSTA: Phase 1b/2a trial in locally advanced PDAC with chemo & IO Phase 1b/2a proof-of-concept safety and early efficacy study of LSTA1 in combination with durvalumab, gemcitabine and nab-paclitaxel, as first-line treatment in locally advanced

  37. Slide 37: Preliminary Efficacy as of May 2025 – Best Overall Response Rate

    Positive Early Clinical Results in Combination with I/O Preliminary Efficacy as of May 2025 – Best Overall Response Rate Cohort 3: Overall Response Rate 69% Disease Control Rate 100% Key: Cohort 1 Cohort 2 Cohort 3: 11/16 with PR Stable disease Partial response * Complete response Percent Change (%)

  38. Slide 38: Attractive Commercial Opportunity

    Attractive Commercial Opportunity 38

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

    Attractive Commercial Opportunity Certepetide can be used throughout the mPDAC treatment paradigm First-Line (1L) Second-Line (2L) Third-Line (3L) Good Patient FOLFIRINOX Gemcitabine Immunotherapy or Functional or + other treatment Status NALIRIFOX Nab-paclitaxel Patient CERTEPETIDE CERTEPETIDE CERT

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

    Attractive Commercial Opportunity Certepetide’s broad value proposition beyond mPDAC Breadth of Applicability Certepetide’s Commercial Prospects Oncologic applications:  Well-characterized, de-risked, in later stage development  Locally advanced PDAC - a population recognized as non-  Capital eff

  41. Slide 41: Certepetide special regulatory designations and benefits

    Attractive Commercial Opportunity Certepetide special regulatory designations and benefits FDA Rare Pediatric Disease FDA Fast Track Designation Orphan Drug Designations Designation • Pancreatic cancer (FDA) • Osteosarcoma (FDA) • Pancreatic cancer (FDA & EMA) • Malignant glioma (FDA)  Eligible for

  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 trial

    Poised for Global Phase 3 Initiation Requisite clinical development steps completed in preparation for Phase 3 trial Full NDA-ready preclinical toxicology package  no DLTs observed Phase 1 dose ranging study in 1L mPDAC  No DLTs observed; safety profile consistent with co-administered SoC  Certep

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

    Poised for Global Phase 3 Initiation 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 mPD

  45. Slide 45: Certepetide Development Portfolio

    Certepetide Development Portfolio 45

  46. Slide 46: Certepetide capital efficient clinical development plan

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

  47. Slide 47: Certepetide preclinical activities and results

    Certepetide – Clinical / Regulatory Development Portfolio Certepetide preclinical activities and results Sponsor(s) Indication Objective and Description Results Assess the therapeutic effect of adding certepetide to bevacizumab (VEGF inhibitor) on the size and number of  Encouraging early signals s

  48. Slide 48: Clinical Development Milestones

    Clinical Development Milestones 48

  49. Slide 49: A wealth of key certepetide clinical milestones

    Clinical Development Milestones A wealth of key certepetide clinical milestones 1Q 2024 2Q 2024 3Q 2024 4Q 2024 1Q 2025 2Q 2025 3Q 2025 4Q 2025 1Q 2026 2Q 2026 FDA EOP2 Final Cohort A & B ASCEND [AUS, NZ] Cohort A data meeting Cohort B data PFS/OS data First-line mPDAC 1L CCA LPI 1L OS 2L OS data BO

  50. Slide 50: Financial Summary

    Financial Summary 50

  51. Slide 51: Capital projected to fund all clinical programs to data

    Financial Summary Capital projected to fund all clinical programs to data Cash & Investments Debt Projected Cash Runway into As of 6/30/2025 $22.0M $0 4Q 2026 Common Shares Outstanding (6/30/2025): 8.6 million shares Options Outstanding (6/30/2025): Exercise Price: $0.02 - $4.22 = 1,293,100 shares 1

  52. Slide 52: Key factors supporting investment in Lisata Therapeutics

    Strong Investment Rationale Key factors supporting investment in Lisata Therapeutics INTELLECTUAL PEOPLE MILESTONES CAPITAL PARTNERING PROPERTY Seasoned Platform Proprietary field- Multiple product $22.0 million management with technology leading technology and business cash*- no debt; successful va

  53. Slide 53: Targeted Therapy Delivered

    Targeted Therapy Delivered Investor Relations Contact: John D. Menditto VP, IR & Corporate Communications Tel: (908) 842-0084 | Email: jmenditto@lisata.com Nasdaq: LSTA | www.lisata.com © Lisata Therapeutics, Inc. 2025. All rights reserved.

  54. Slide 54: Appendix

    Appendix 54

  55. Slide 55: Certepetide capital efficient clinical development plan

    Appendix Certepetide capital efficient clinical development plan Development Partner(s) Indication and Stage of Strategic Rationale [Development Venue] Trial Product/Comparator Development Lisata/AGITG First-line mPDAC; Phase 2b Corroborate Phase 1b results in a placebo-controlled trial and [Austral

  56. Slide 56: ASCEND: Phase 2b, blinded, randomized trial in mPDAC

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

  57. Slide 57: ASCEND Phase 2b trial design

    Appendix ASCEND Phase 2b trial design ONE IV push of certepetide per INTERVENTION Arm (N=63) • Nab-paclitaxel 125 mg/m2 IV infusion Phase 2b randomized, double-blind SoC treatment • ONE IV push of Certepetide 3.2 mg/kg study in mPDAC testing gemcitabine + • Gemcitabine 1000 mg/m2 IV infusion nab-pac

  58. Slide 58: Phase 1b/2a open-label trial in mPDAC in China (CEND1-201)

    Appendix Phase 1b/2a open-label trial in mPDAC in China (CEND1-201) Sponsor/Partner  Qilu Pharmaceutical (funds all development in China)  Evaluate safety, pharmacokinetics and preliminary efficacy of certepetide added to SoC in Objective Chinese patients with mPDAC  Phase 1b/2a open-label study

  59. Slide 59: Qilu Phase 1b/2a trial design

    Appendix Qilu Phase 1b/2a trial design Phase 1b/2a study evaluating the safety, pharmacokinetics, and preliminary efficacy of certepetide for injection in Chinese patients with advanced metastatic pancreatic ductal adenocarcinoma Certepetide 1.6 mPDAC 7 Day Safety mg/kg + nab-pac* + Disease 1.6 mg/k

  60. Slide 60: CENDIFOX: Phase 1b/2a open-label trial in PDAC and other cancers

    Appendix CENDIFOX: Phase 1b/2a open-label trial in PDAC and other cancers  University of Kansas Medical Center (Investigator initiated trial in U.S.) Sponsor/Partner  KUCC funded; Lisata provides certepetide  Evaluate the safety and therapeutic effect of certepetide in combination with neoadjuvan

  61. Slide 61: CENDIFOX Phase 1b/2a trial design

    Appendix CENDIFOX Phase 1b/2a trial design Phase 1b/2a open-label trial of certepetide in combination with neoadjuvant FOLFIRINOX based therapies in pancreatic, colon and appendiceal cancers (CENDIFOX) COHORT 1 Resectable and borderline resectable PDAC Repeat FOLFIRINOX Tissue FOLFIRINOX Biopsy (± P

  62. Slide 62: BOLSTER: Phase 2 blinded, randomized trial in cholangiocarcinoma

    Appendix BOLSTER: Phase 2 blinded, randomized trial in cholangiocarcinoma Sponsor/Partner  Lisata (U.S.)  Evaluate the preliminary efficacy, safety and tolerability of certepetide in combination with Objective standards of care in subjects with first- and second-line cholangiocarcinoma  Phase 2 r

  63. Slide 63: BOLSTER Phase 2a trial design

    Appendix BOLSTER Phase 2a trial design Phase 2a, double-blind, placebo-controlled, multi-center, randomized study evaluating certepetide when added to standard of care (SoC) versus standard of care alone in subjects with first- and second-line cholangiocarcinoma Disease Confirm Certepetide + cisplat

  64. Slide 64: Phase 2 double-blind, placebo-controlled trial in mPDAC in China

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

  65. Slide 65: Qilu Phase 2b trial design

    Appendix Qilu Phase 2b trial design Phase 2b, double-blind, placebo-controlled, randomized, multicenter study evaluating the safety and efficacy of certepetide when added to standard of care (nab-paclitaxel and gemcitabine) vs. standard of care alone and placebo in Chinese subjects with locally adva

  66. Slide 66: iLSTA: Phase 1b/2a trial in locally advanced PDAC with chemo & IO

    Appendix iLSTA: Phase 1b/2a trial in locally advanced PDAC with chemo & IO  WARPNINE, Inc. (registered charity in Australia) is funding trial Sponsor/Partner  Lisata providing study drug  Evaluate safety and therapeutic effect of LSTA1 in combination with IO & Chemo in locally Objective advanced

  67. Slide 67: iLSTA Phase 1b/2a trial design

    Appendix iLSTA Phase 1b/2a trial design Phase 1b/2a proof-of-concept safety and early efficacy study of LSTA1 in combination with durvalumab, gemcitabine and nab-paclitaxel, as first-line treatment in locally advanced non-resectable pancreatic ductal adenocarcinoma Cohort 1 Gemcitabine + nab-paclita

  68. Slide 68: Preliminary iLSTA trial results poster at 2025 ASCO-GI Symposium

    Appendix Preliminary iLSTA trial results poster at 2025 ASCO-GI Symposium An 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

  69. Slide 69: Updated preliminary iLSTA trial results poster at 2025 ESMO-GI

    Appendix Updated preliminary iLSTA trial results poster at 2025 ESMO-GI 69

  70. Slide 70: Phase 2a trial of certepetide with SoC in first-line GBM

    Appendix Phase 2a trial of certepetide with SoC in first-line GBM  Tartu University Hospital (Investigator initiated trial in Estonia, Latvia and Lithuania) Sponsor/Partner  Lisata providing study drug and funding trial  Evaluate safety, tolerability, and therapeutic effect of certepetide in comb

  71. Slide 71: GBM Phase 2a trial design

    Appendix GBM Phase 2a trial design Phase 2a proof-of-concept double-blind, placebo-controlled, randomized, proof-of-concept study evaluating certepetide when added to standard of care (temozolomide) versus temozolomide and matching certepetide placebo in subjects with newly diagnosed GBM Safety Lead

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