Lisata Therapeutics, Inc. · NASDAQ:LSTA

Lisata Therapeutics — Investor Presentation (February 2025)

56 slides from Lisata Therapeutics's investor presentation, Feb 27, 2025

  1. Slide 1: Corporate Presentation - Targeted Therapy Delivered

    © 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 | February 27, 2025 Nasdaq: LSTA Exhibit 99.2

  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 therapeutics company rapidly developing a novel solid tumor targeting and penetration technology with tumor microenvironment (TME) modifying properties. MISSION To enhance the treatment benefits of existing and emerging th

  5. Slide 5: Key attributes

    Company Overview 5 Lisata Therapeutics (Nasdaq: LSTA): Key attributes Cash runway extending into 2Q2026 with no debt, funding current clinical programs Seasoned management with successful international drug development experience and expertise Platform technology validated by existing partnerships w

  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 and 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: Partnerships

    Partnerships Noteworthy existing relationships and potential for many more 11

  12. Slide 12: Existing partnerships support certepetide's promise and broad applicability

    Existing partnerships support certepetide’s promise and broad applicability Partnerships 12 R&D alliances contribute resources with minimal commercial interest in certepetide  Australasian Gastro-Intestinal Trials Group - Clinical Trialists Consortium (Australia & New Zealand)  WARPNINE - Foundati

  13. Slide 13: Certepetide Strong Scientific Foundation and Rationale

    13 Certepetide Strong Scientific Foundation and Rationale

  14. Slide 14: Certepetide mechanism of action: Unique, multi-step approach

    Certepetide mechanism of action: Unique, multi-step approach Certepetide - Strong Scientific Foundation and Rationale 14 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

  15. Slide 15: 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. 15 Certepetide - Strong Scientific Foundation and Rationale Whole body imaging of mice with pancreatic ductal adenocarcinoma (arrow) dosed

  16. Slide 16: Broad applicability and activity of certepetide/iRGD consistently demonstrated

    Broad applicability & activity of certepetide/iRGD consistently demonstrated Sampling of >370 scientific publications showing improved survival 16 Certepetide - Strong Scientific Foundation and Rationale Breast cancer + Herceptin®Lung cancer + gemcitabine Zhang, et al., Plos One, 2015 Breast cancer

  17. Slide 17: Certepetide/iRGD improves immunotherapy efficacy in preclinical solid tumor models

    Certepetide/iRGD consistently improves immunotherapy efficacy in multiple preclinical solid tumor models Certepetide - Strong Scientific Foundation and Rationale Solid Tumor Types  Intrahepatic cholangiocarcinoma  Pancreatic adenocarcinoma  Prostate cancer  Breast cancer  Non-Small Cell Lung Ca

  18. Slide 18: Certepetide improves immunotherapy impact in cholangiocarcinoma

    Certepetide improves immunotherapy impact in cholangiocarcinoma 18 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

  19. Slide 19: 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

  20. Slide 20: Certepetide development strategy: A two-pillar approach

    Certepetide development strategy: A two-pillar approach 20 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 2 initial results  Phase 3 preparation un

  21. Slide 21: Certepetide improved survival in mPDAC in two Phase 1 trials

    21 Certepetide - Strong Scientific Foundation and Rationale Certepetide improved survival in mPDAC in two independent, multicenter Phase 1 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.

  22. Slide 22: Internal consistency of response in two Phase 1 trials

    Certepetide demonstrated internal consistency of response in two Phase 1 trials Certepetide - Strong Scientific Foundation and Rationale 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 22 Complete Res

  23. Slide 23: 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

  24. Slide 24: ASCEND: Phase 2 study of certepetide in mPDAC

    ASCEND: Phase 2 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 results announcements to scientific mee

  25. Slide 25: ASCEND: Preliminary Cohort A progression-free survival data

    ASCEND: Preliminary 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: Progressi

  26. Slide 26: ASCEND: Preliminary Cohort A overall survival data

    ASCEND: Preliminary Cohort A overall survival data 26 Certepetide - Strong Scientific Foundation and Rationale 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. 9.72 months); separation oc

  27. Slide 27: 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  Two Phase 1 clinical trials (CEND1-001 in Australia and CEND1-201 in China) demonstrate that certepetide plus SoC chemotherapy improves overall survival in metastatic PDAC akin to t

  28. Slide 28: Certepetide Clinical/Regulatory Development Portfolio

    28 Certepetide Clinical/Regulatory Development Portfolio

  29. Slide 29: Certepetide special regulatory designations and benefits

    Certepetide – Clinical / Regulatory Development Portfolio Certepetide special regulatory designations and benefits 29 FDA Fast Track Designation • Pancreatic cancer (FDA)  Eligible for Accelerated Approval, Priority Review and Rolling Review  Provides for program-specific guidance from and frequen

  30. Slide 30: Certepetide capital efficient clinical development plan

    Certepetide capital efficient clinical development plan Certepetide – Clinical / Regulatory Development Portfolio 30 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

  31. Slide 31: Certepetide preclinical activities and results

    Certepetide preclinical activities and results Sponsor(s) Indication Objective and Description Results University of Cincinnati/Lisata Endometriosis Assess the therapeutic effect of adding certepetide to bevacizumab (VEGF inhibitor) on the size and number of endometriotic lesions.  Certepetide + be

  32. Slide 32: Clinical Development Milestones

    Clinical Development Milestones 32

  33. Slide 33: A wealth of anticipated key certepetide clinical milestones

    A wealth of anticipated key certepetide clinical milestones Development Milestones 33 2Q 2023 3Q 2023 4Q 2023 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 an

  34. Slide 34: Financial Highlights

    Financial Highlights Pe - Bed Ps wit oe ae res, % =

  35. Slide 35: Capital projected to fund all clinical programs to data

    Capital projected to fund all clinical programs to data Financial Highlights 35 $31.2M Cash & Investments As of 12/31/2024 $0 Debt 2Q2026 Projected Cash Runway into Common Shares Outstanding (12/31/2024): 8.4 million shares Options Outstanding (12/31/2024): Exercise Price: $0.02 - $4.22 = 1,203,600

  36. Slide 36: Key factors supporting investment in Lisata Therapeutics

    * As of 12/31/2024; includes investments Key factors supporting investment in Lisata Therapeutics 36 Strong Investment Rationale PEOPLE Seasoned management with successful international drug development experience and expertise INTELLECTUAL PROPERTY Proprietary field- leading technology with global

  37. Slide 37: 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

  38. Slide 38: Appendix

    Appendix 38

  39. Slide 39: 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

  40. Slide 40: ASCEND: Phase 2b, blinded, randomized trial in mPDAC

    ASCEND: Phase 2b, blinded, randomized trial in mPDAC 40 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

  41. Slide 41: ASCEND: Phase 2b, blinded, randomized trial in mPDAC (design)

    ASCEND: Phase 2b, blinded, randomized trial in mPDAC Appendix R INTERVENTION Arm (N=60) • Nab-paclitaxel 125 mg/m2 IV • Certepetide 3.2 mg/kg IV • Gemcitabine 1000 mg/m2 IV Dose on days 1, 8, 15 every 28 days CONTROL Arm (N=30) • Nab-paclitaxel 125 mg/m2 IV • Matching certepetide Placebo IV • Gemcit

  42. Slide 42: 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

  43. Slide 43: CEND1-201 study schema

    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

  44. Slide 44: CENDIFOX: Phase 1b/2a trial overview

    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

  45. Slide 45: CENDIFOX: Phase 1b/2a study schema

    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

  46. Slide 46: 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

  47. Slide 47: BOLSTER: study schema

    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 N=20 N=2

  48. Slide 48: Phase 2 double-blind 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

  49. Slide 49: Phase 2 blinded, placebo-controlled trial in mPDAC in China: schema

    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

  50. Slide 50: iLSTA: Phase 1b/2a trial in locally advanced PDAC with chemo and IO

    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

  51. Slide 51: iLSTA: study schema

    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

  52. Slide 52: Preliminary iLSTA Trial Results

    Preliminary iLSTA Trial Results Poster at 2025 ASCO GI Symposium Appendix 52An abstract with a detailed summary of the poster presentation is also available on the ASCO GI website: https://meetings.asco.org/abstracts-presentations/241611

  53. Slide 53: 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

  54. Slide 54: Phase 2a GBM trial: study schema

    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

  55. Slide 55: FORTIFIDE: Phase 1b/2a continuous infusion study of certepetide

    Appendix 55 FORTIFIDE: Phase 1b/2a continuous infusion study of certepetide Sponsor/Partner  Lisata (U.S. only) Objective  Evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics, and efficacy of certepetide when given as a 4-hour continuous infusion in combination with SoC in subjec

  56. Slide 56: FORTIFIDE: study schema

    FORTIFIDE: Phase 1b/2a continuous infusion study of certepetide 56 Subjects with 1L mPDAC Obtain Informed Consent Confirm Eligibility Gemcitabine, certepetide 3.2 mg/kg single IV push/ 4-hour continuous placebo infusion + nab-paclitaxel Days 1, 8, and 15 every 28 days Gemcitabine, certepetide placeb

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