Lisata Therapeutics, Inc. · NASDAQ:LSTA

Lisata Therapeutics — Investor Presentation (November 2024)

53 slides from Lisata Therapeutics's investor presentation, Nov 12, 2024

  1. Slide 1: Targeted Therapy Delivered: Corporate Presentation

    © L i s a t a T h e r a p e u t i c s , I n c . 2 0 2 4 . A l l r i g h t s r e s e r v e d . Targeted Therapy Delivered David J. Mazzo, Ph.D. President and Chief Executive Officer www.lisata.com Corporate Presentation | November 12, 2024 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 WHAT WE ARE Clinical-stage therapeutics company rapidly developing a novel solid tumor targeting and penetration technology with tumor microenvironment (TME) modifying properties. OUR MISSION To enhance the treatment benefits of existing and emer

  5. Slide 5: Key attributes

    Company Overview 5 Lisata Therapeutics (Nasdaq: LSTA): Key attributes Projected cash runway into early 2026, funding all current development programs through data Seasoned management with successful international drug development experience and expertise Platform technology validated by existing par

  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 Globally in 2022(2),(3) 20 million new cancer cases 10 million deaths >90% solid tumors 35 million new cancer cases 18.5 million deaths >90% solid tumors +77% Examples of solid tumors: Lung, breast, pancreas, liver, bile duct (chola

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

    Current solid tumor treatments & patient outcomes are suboptimal Challenging tumor morphology and tumor microenvironment (TME) present major obstacles to optimized outcomes Tumor stroma acts as a physical barrier to anti-cancer agents An immunosuppressive TME contributes to tumor resistance and/or m

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

    Certepetide designed to optimize solid tumor treatment outcomes Dense stromal barrier physically inhibiting drug entry Employ internalizing RGD* (iRGD) peptide to target tumor and trigger CendR active transport CHALLENGE APPROACH Immunosuppressive TME which impedes the immune system Employ specific

  11. Slide 11: Partnerships

    Partnerships Noteworthy existing relationships and potential for many more 11

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

    Existing partnerships support certepetide’s promise & broad applicability Strategic commercial partnership in China with Qilu Pharmaceutical  Qilu granted exclusive rights in China, Taiwan, Hong Kong and Macau  Qilu assumes all development and commercialization responsibilities/costs in licensed t

  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 & activity of certepetide/iRGD consistently demonstrated

    Broad applicability & activity of certepetide/iRGD consistently demonstrated Sampling of >350 scientific publications showing improved survival 16 Breast cancer + Herceptin®Lung cancer + gemcitabine Zhang, et al., Plos One, 2015 Breast cancer + nanoparticle nab-paclitaxel GI cancer + adoptive cell t

  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 17 Certepetide/iRGD vs. Control GroupStudy Description → Significantly improved overall survival → Significantly reduced tumor volume → Significantly reduced metastases  Intrahepatic cholangioca

  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 is composed of two main pillars

    Certepetide development strategy is composed of two main pillars 20 Pursue rapid global registration in pancreatic ductal adenocarcinoma (mPDAC), initially combined with gemcitabine/nab-paclitaxel standard-of-care (SoC)  Phase 2b 100% enrolled  Phase 3 preparation underway Demonstrate certepetide

  21. Slide 21: Certepetide improved survival in metastatic pancreatic cancer in two Phase 1b/2a studies

    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 21 Certepetide - Strong Scientific Foundation and Rationale Certepetide improved survival in metastatic pancreatic cancer in two independent multicenter

  22. Slide 22: Certepetide demonstrated internal consistency of response in two Phase 1b/2a studies

    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 Certepetide demonstrated internal consistency of response in two Phase 1b/2a studies Complete Response Partial Response Objective Response Rate Disea

  23. Slide 23: 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

  24. Slide 24: Accumulating clinical data demonstrate certepetide's ability to augment anti-cancer efficacy

    Accumulating clinical data demonstrate certepetide’s ability to augment anti-cancer efficacy of chemotherapy alone and with immunotherapy 24 Certepetide - Strong Scientific Foundation and Rationale Certepetide Clinical Data Summary to Date  Two Phase 1b/2a clinical trials (CEND1-001 – Australia and

  25. Slide 25: Certepetide Clinical/Regulatory Development Portfolio

    25 Certepetide Clinical/Regulatory Development Portfolio

  26. Slide 26: Certepetide special regulatory designations and benefits

    Certepetide – Clinical / Regulatory Development Portfolio Certepetide special regulatory designations and benefits 26 FDA Fast Track Designation • Pancreatic cancer (FDA)  Eligible for Accelerated Approval, Priority Review and Rolling Review  Provides for program-specific guidance from and frequen

  27. Slide 27: Certepetide capital efficient clinical development plan

    Certepetide capital efficient clinical development plan Current Phase DescriptionIndicationSponsor(s) Phase 3Phase 2Phase 1  ASCEND: Phase 2b, placebo-controlled trial (N=158)  Gemcitabine/nab-paclitaxel + certepetide or placebo  Australia/New Zealand First-line mPDACAGITG/Lisata  BOLSTER: Phase

  28. Slide 28: Certepetide preclinical activities and milestones

    Certepetide preclinical activities and milestones Upcoming MilestonesObjective and DescriptionIndicationSponsor(s) Target date for data: 1Q2025 Assess the therapeutic effect of adding certepetide to bevacizumab (VEGF inhibitor) on the size and number of endometriotic lesions.  Certepetide + bevaciz

  29. Slide 29: Clinical Development Milestones

    Clinical Development Milestones 29

  30. Slide 30: A wealth of anticipated key certepetide clinical milestones

    A wealth of anticipated key certepetide clinical milestones 30 1Q 20264Q 20253Q 20252Q 20251Q 20254Q 20243Q 20242Q 20241Q 20244Q 20233Q 20232Q 2023 ASCEND [AUS, NZ] First-line mPDAC BOLSTER [USA] First- and second-line CCA CENDIFOX [USA] Pancreatic, Colon and Appendiceal Cancers Qilu: Phase 1b/2a [C

  31. Slide 31: Financial Highlights

    Financial Highlights 31

  32. Slide 32: Capital projected to fund all clinical programs to data

    Capital projected to fund all clinical programs to data Financial Highlights 32 $35.9M Cash & Investments As of 9/30/2024 $0 Debt 1Q2026 Projected Cash Runway Into 8.3 million sharesCommon Shares Outstanding (9/30/2024): 1.5 million shares Options Outstanding (9/30/2024): Exercise Price: $0.02 - $4.

  33. Slide 33: Investment Thesis

    Investment Thesis  Promising asset based on a body of compelling data  Rational and focused development portfolio  Highly experienced management team  Financially stable company 33

  34. Slide 34: Key factors supporting investment in Lisata Therapeutics

    * As of 9/30/2024; includes investments Key factors supporting investment in Lisata Therapeutics 34 Strong Investment Rationale PEOPLE Seasoned management with successful international drug development experience and expertise INTELLECTUAL PROPERTY Proprietary field- leading technology with global I

  35. Slide 35: 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 4 . 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

  36. Slide 36: Appendix

    Appendix 36

  37. Slide 37: Strategic rationale and stage of development by trial

    Strategic Rationale Stage of Development Indication and Trial Product/Comparator Development Partner(s) [Development Venue] Corroborate Phase 1b results in a placebo-controlled trial and evaluate 2 dose regimens of certepetide for dose optimization Phase 2b (ASCEND) First-line mPDAC; Gemcitabine/nab

  38. Slide 38: ASCEND: Phase 2b, blinded, randomized trial in mPDAC

     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 AUS) Sponsor/Partner  Corroborate Phase 1b results in a placebo-controlled study 

  39. Slide 39: ASCEND trial schema

    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 • Gemcitabine 1000 mg/m2 IV Dose on days 1, 8, 15 every 28 days INTERV

  40. Slide 40: Phase 1b/2a open-label trial in mPDAC in China (CEND1-201)

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

  41. Slide 41: CEND1-201 trial 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

  42. Slide 42: CENDIFOX: Phase 1b/2a trial in pancreatic, colon and appendiceal cancers

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

  43. Slide 43: CENDIFOX trial 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

  44. Slide 44: BOLSTER: Phase 2 blinded, randomized trial in Cholangiocarcinoma

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

  45. Slide 45: BOLSTER trial 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

  46. Slide 46: Phase 2 double-blind, placebo-controlled trial in mPDAC in China

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

  47. Slide 47: Phase 2 China trial 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=60 N=60 Phase 2b, double-blind, pl

  48. Slide 48: iLSTA: Phase 1b/2a trial in locally advanced PDAC with chemo & IO

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

  49. Slide 49: iLSTA trial 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

  50. Slide 50: Phase 2a trial of certepetide with SoC in first-line GBM

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

  51. Slide 51: GBM trial 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

  52. Slide 52: FORTIFIDE: Phase 1b/2a continuous infusion study in second-line mPDAC

     Lisata (U.S. only)Sponsor/Partner  Evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics, and efficacy of certepetide when given as a 4-hour continuous infusion in combination with SoC in subjects with second-line mPDAC who have progressed on FOLFIRINOX. Haystack Oncology MRD tech

  53. Slide 53: FORTIFIDE: Phase 1b/2a continuous infusion study of certepetide

    FORTIFIDE: Phase 1b/2a continuous infusion study of certepetide Subjects with 2L 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 placebo s

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