Lisata Therapeutics, Inc. · NASDAQ:LSTA

Lisata Therapeutics — Investor Presentation (August 2024)

50 slides from Lisata Therapeutics's investor presentation, Aug 12, 2024

  1. Slide 1: 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 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 | August 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: Company Overview

    Company Overview 4 Lisata Therapeutics (Nasdaq: LSTA) Projected cash runway into early 2026, funding all development programs through data A clinical stage therapeutics company rapidly developing a novel solid tumor targeting and penetration technology with TME* modifying properties to improve the e

  5. Slide 5: Seasoned leadership with proven track record in drug approvals worldwide

    Seasoned leadership with proven track record in drug approvals worldwide 5 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, a

  6. Slide 6: Accomplished, industry veteran, independent board directors

    Accomplished, industry veteran, independent board directors Detailed bios can be found at www.lisata.com 6 Gregory B. Brown, MD Chairman Biopharma executive with expertise in evaluating scientific, technical, clinical, and medical products as well as in healthcare systems and payor/reimbursement dyn

  7. Slide 7: Therapeutic Focus and Rationale

    Therapeutic Focus and Rationale Problem, Solution and Approach 7

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

    Improved solid tumor treatment remains a vital, growing global need Therapeutic Focus and Rationale 8 2022 20 million new cases2 9.7 million deaths 2050 35 million new cases2 18.5 million deaths 77% In 2023, in the U.S. alone, of ~2 million newly diagnosed cancer cases, >90% were solid tumors1 1 htt

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

    9 Therapeutic Focus and Rationale Current solid tumor treatments & patient outcomes are suboptimal Diagram: Abizanda-Campo, S. et al, Microsyst Nanoeng 9, 154 (2023)  Tumor stroma acts as a physical barrier to anti-cancer agents  An immunosuppressive tumor microenvironment (TME) contributes to tum

  10. Slide 10: Maximizing solid tumor treatment success

    Maximizing solid tumor treatment success Step 1 Employ a tumor selective RGD motif Optimize Tumor Targeting OBJECTIVE: APPROACH: Step 2 Employ Internalizing RGD (iRGD) peptide to trigger CendR active transport mechanism Enhance Tumor Penetration OBJECTIVE: APPROACH: Step 3 Employ a specific iRGD tha

  11. Slide 11: Certepetide promises optimized solid tumor treatment outcomes

    Certepetide promises optimized solid tumor treatment outcomes Certepetide converts tumor stroma from a barrier to a conduit for anti-cancer drugs 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. 11 Therapeutic Fo

  12. Slide 12: Certepetide development strategy is composed of two main pillars

    Certepetide development strategy is composed of two main pillars Therapeutic Focus and Rationale 12 Pursue rapid global registration in pancreatic ductal adenocarcinoma (mPDAC), initially combined with gemcitabine/nab-paclitaxel standard-of-care (SoC)  Phase 2b 100% enrolled  By 2030, pancreatic c

  13. Slide 13: Partnerships

    Partnerships Noteworthy existing relationships and potential for many more 13

  14. Slide 14: Existing partnerships support certepetide's promise and broad applicability

    Existing partnerships support certepetide’s promise and broad applicability Strategic commercial partnership in China with Qilu Pharmaceutical  Qilu granted exclusive rights to certepetide in China, Taiwan, Hong Kong and Macau  Qilu assumes all development and commercialization responsibilities/co

  15. Slide 15: Certepetide: Strong Scientific Foundation and Rationale

    15 Certepetide (formerly LSTA1) Strong Scientific Foundation and Rationale

  16. Slide 16: Certepetide selective tumor targeting & penetration mechanism of action

    Certepetide selective tumor targeting & penetration mechanism of action Certepetide - Strong Scientific Foundation and Rationale 161 Ding et al., Nature Comm, 2019. 1 Integrin binding 2 Proteolytic cleavage 3 Neuropilin-1 binding 4 Resulting tumor penetration Bound certepetide is proteolytically- cl

  17. Slide 17: Certepetide selectively and efficiently facilitates intratumoral penetration

    Certepetide selectively and efficiently facilitates intratumoral penetration 1 Braun et al., Nature Mater. 2014. 2 Liu, Braun et al., Nature Comm. 2017. 17 Certepetide - Strong Scientific Foundation and Rationale Whole body imaging of mice with pancreatic ductal adenocarcinoma (arrow) dosed with Flu

  18. Slide 18: Certepetide/iRGD activity & broad applicability consistently demonstrated

    Certepetide/iRGD activity & broad applicability consistently demonstrated Sampling of >350 scientific publications showing improved survival with certepetide/iRGD 18 Breast cancer + Herceptin®Lung cancer + gemcitabine Zhang, et al., Plos One, 2015 Breast cancer + nanoparticle Abraxane GI cancer + ad

  19. Slide 19: Certepetide Ph 1b/2a results: Improvement of SoC efficacy

    N= # of study participants Median Overall Survival Median Progression-Free Survival Objective Response Rate Complete Response Partial Response Stable Disease Progressive Disease Disease Control Rate 16 weeks CA19-9 >20% drop Gemcitabine + Nab-paclitaxel1 N=431 8.5 mos. 5.5 mos. 23% (99) 0.2% (1) 23%

  20. Slide 20: Certepetide Ph 1b/2a results: Improved survival vs. SoC alone

    1 Von Hoff D, et al., New England Journal of Medicine, 2013. 2 Dean A, et al., The Lancet Gastroenterology & Hepatology, 2022 1.0 3.0 5.0 7.0 9.0 11.0 13.0 Median Overall Survival (Months) Median Progression Free Survival (Months) M on th s Gemcitabine + Nab-paclitaxel Gemcitabine + Nab-paclitaxel +

  21. Slide 21: Certepetide Ph 1b/2a results: Consistent improvement across associated endpoints

    0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% 80.0% 90.0% 100.0% Complete Response Partial Response Objective Response Rate Disease Control Rate at 16 weeks CA19-9 >20% drop Gemcitabine + Nab-paclitaxel Gemcitabine + Nab-paclitaxel + certepetide 1 Von Hoff D, et al., New England Journal of Medicine

  22. Slide 22: Evidence of certepetide activity in other solid tumors

    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 demonstrated1  53-year-old male with mGEAC with significant (> 5cm) noda

  23. Slide 23: Certepetide Clinical/Regulatory Development Portfolio

    23 Certepetide Clinical/Regulatory Development Portfolio

  24. Slide 24: Certepetide regulatory designations and implications

    Certepetide – Clinical / Regulatory Development Portfolio Certepetide regulatory designations and implications 24 FDA Fast Track Designation  Certepetide received Fast Track Designation from FDA for pancreatic cancer  More frequent communication with and program-specific guidance from FDA  Eligib

  25. Slide 25: Certepetide capital efficient development plan

    Certepetide capital efficient 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 2a, plac

  26. Slide 26: Development Milestones

    Development Milestones 26

  27. Slide 27: A wealth of anticipated key certepetide milestones

    A wealth of anticipated key certepetide milestones 27 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 [CHN] First

  28. Slide 28: Financial Highlights

    Financial Highlights 28

  29. Slide 29: Capital projected to fund all clinical programs to data

    Capital projected to fund all clinical programs to data Financial Highlights 29 $38.3M Cash & Investments As of 6/30/2024 $0 Debt 1Q2026 Projected Cash Runway Into 8.3 million sharesCommon Shares Outstanding (6/30/2024): 1.5 million shares Options Outstanding (6/30/2024): Exercise Price: $0.02 - $4.

  30. Slide 30: Investment Thesis

    Investment Thesis  Promising asset based on a body of compelling data  Rational and focused development program  Highly experienced management team  Financially stable company 30

  31. Slide 31: Key factors supporting investment in Lisata Therapeutics

    * As of 6/30/2024; includes investments Key factors supporting investment in Lisata Therapeutics 31 Strong Investment Rationale PEOPLE Seasoned management with successful international development experience and expertise INTELLECTUAL PROPERTY Proprietary field-leading technology in underserved glob

  32. Slide 32: 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 o: (908) 842-0084 | e: jmenditto@lisata.com Nasdaq: LSTA | www.lisata.com Targeted Therapy Delivered

  33. Slide 33: Appendix

    Appendix 33

  34. Slide 34: Strategic rationale and trial overview by development stage

    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

  35. Slide 35: 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 

  36. Slide 36: ASCEND trial design 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

  37. Slide 37: Phase 1b/2a open-label trial in mPDAC in China

     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

  38. Slide 38: Qilu Phase 1b/2a 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

  39. Slide 39: 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

  40. Slide 40: 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

  41. Slide 41: 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

  42. Slide 42: 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

  43. Slide 43: 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

  44. Slide 44: Qilu Phase 2b 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

  45. Slide 45: 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

  46. Slide 46: 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

  47. Slide 47: 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

  48. Slide 48: 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

  49. Slide 49: 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

  50. Slide 50: 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

Lisata Therapeutics — Investor Presentation (August 2024) on 6ix