Lisata Therapeutics, Inc. · NASDAQ:LSTA

Lisata Therapeutics — Investor Presentation (November 2023)

51 slides from Lisata Therapeutics's investor presentation, Nov 2, 2023

  1. Slide 1: Targeted Therapy Delivered: Corporate Presentation

    C o p y r i g h t © 2 0 2 3 L i s a t a T h e r a p e u t i c s , I n c . A l l r i g h t s r e s e r v e d . Targeted Therapy Delivered Corporate Presentation | November 2, 2023 Nasdaq: LSTA www.lisata.com Exhibit 99.2

  2. Slide 2: Forward-looking statements advisory

    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, in

  3. Slide 3: Company Overview: Lisata at a Glance

    Company Overview Lisata at a Glance

  4. Slide 4: Lisata Therapeutics: Summary

    Lisata Therapeutics (Nasdaq: LSTA): Summary A clinical stage therapeutics development company rapidly advancing a novel solid tumor targeting and penetration technology to improve the efficacy of anti-cancer drugs Seasoned management with successful drug development experience and expertise Propriet

  5. Slide 5: Therapeutic Focus and Rationale

    Therapeutic Focus and Rationale Problem, Solution and Approach

  6. Slide 6: Improved solid tumor cancer treatment is a vital global need

    Improved solid tumor cancer treatment is a vital global need 6 1 www.who.int/news-room/fact-sheets/detail/cancer 2https://seer.cancer.gov/statfacts/html/common.html; As of November 2, 2023 In 2023, in the U.S. alone, there were ~2 million newly diagnosed cancer cases, with solid tumors comprising ov

  7. Slide 7: Targeting and penetrating tumors present distinct challenges

     Targeting and penetrating tumors present distinct challenges • Tumor stroma acts as a physical barrier, limiting the penetration and distribution of anti-cancer agents into the tumor • Tumor microenvironment (TME) immunosuppressive cells contribute to tumor resistance and/or metastases • Prolonged

  8. Slide 8: Leveraging the CendR transport mechanism to improve solid tumor treatment

    Leveraging the CendR transport mechanism to improve solid tumor treatment  RGD peptides serve as targeting agents to tumor cells, but do not enhance penetration and delivery of therapeutic agents  Internalizing RGD peptides (iRGDs) combine targeting and penetration enhancement  LSTA1 (certepetide

  9. Slide 9: LSTA1 promises optimized solid tumor treatment

    LSTA1 promises optimized solid tumor treatment  LSTA1 converts tumor stroma from a barrier to a conduit for anti-cancer drugs  LSTA1 is agnostic to the modality of the companion anti-cancer therapy • Mechanism effective with co-administered or molecularly bound (tethered) anti-cancer therapies • C

  10. Slide 10: LSTA1 development strategy is composed of two main pillars

    LSTA1 development strategy is composed of two main pillars  Pursue rapid global registration in pancreatic ductal adenocarcinoma (mPDAC), initially combined with gemcitabine/nab-paclitaxel standard-of-care (SoC) • Phase 2b >95% enrolled 10  Demonstrate LSTA1 effectiveness when combined with a vari

  11. Slide 11: Partnerships

    Partnerships Noteworthy existing relationships and potential for many more

  12. Slide 12: Existing partnerships support LSTA1 promise and broad applicability

    Existing partnerships support LSTA1 promise and broad applicability Strategic partnership in China with Qilu Pharmaceutical  Exclusive rights to LSTA1 in China, Taiwan, Hong Kong and Macau  Qilu assumes all development and commercialization responsibilities/costs in licensed territories  Strategy

  13. Slide 13: LSTA1 Strong Scientific Foundation and Rationale

    LSTA1 Strong Scientific Foundation and Rationale

  14. Slide 14: LSTA1 Mechanism of Action: Steps 1 & 2 of 3

    αvβ3/β5 integrins LSTA1 (certepetide) (Furin & others) Protease Cleavage CendR Peptide Fragment Tumor or Tumor Vascular Endothelial Cell 14  LSTA1: 9 amino acid cyclic peptide; high binding specificity and affinity to αvβ3/β5 integrins that are upregulated on: • Tumor vascular endothelium • Tumor c

  15. Slide 15: LSTA1 Mechanism of Action: Step 3 of 3

    LSTA1 Mechanism of Action: Step 3 of 3 Neuropilin-1 CendR Peptide Fragment Co-administered or tethered anti-cancer drugs CendR Transport Pathway Tumor or Tumor Vascular Endothelial Cell Gap junction opening 15  The CendR fragment then binds with high affinity and selectivity to an adjacent receptor

  16. Slide 16: LSTA1 selectively and efficiently facilitates intratumoral penetration

    LSTA1 selectively and efficiently facilitates intratumoral penetration Whole body imaging of mice with pancreatic ductal adenocarcinoma (arrow) dosed with Fluorescent Quantum Dots (FQDs) with and without LSTA1 1 Braun et al., Nature Mater. 2014. 2 Liu, Braun et al., Nature Comm. 2017. 16  Etching s

  17. Slide 17: Large body of work shows consistent LSTA1 activity/broad applicability

    1 Hurtado de Mendoza et al, Nature Comms, 2021. 2 Liu X et al., J Clin Invest, 2017. 17 Lung cancer + gemcitabine + LSTA1 Breast cancer + nanoparticle Abraxane + LSTA1 GI cancer + adoptive cell therapy + LSTA1PDAC + irinotecan nanoparticles + LSTA1 Orthotopically transplanted KPC PDAC tumors CEND-1

  18. Slide 18: LSTA1 Phase 1b/2a results: Improvement of SoC efficacy

    LSTA1 Phase 1b/2a results: Compelling 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 N=171 6.8

  19. Slide 19: LSTA1 Phase 1b/2a results: Improved survival vs. SoC alone

    LSTA1 Phase 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

  20. Slide 20: LSTA1 Phase 1b/2a results: Consistent improvement across 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 (Von Hoff et. al) Gemcitabine + Nab-Paclitaxel (CEND1-001) Gemcitabine + Nab-Paclitaxel + LSTA1 LSTA1 Phase 1b/2a results: Co

  21. Slide 21: LSTA1 Clinical Development Portfolio

    LSTA1 Clinical Development Portfolio Fast Track (PDAC - USA) Orphan Drug designated (PDAC – USA/EU & GBM – USA)

  22. Slide 22: Implications of Fast Track and Orphan Drug designations

    Implications of Fast Track and Orphan Drug designations 22  Orphan Drug Designation • Incentives such as tax credits, marketing exclusivity, fee waivers and the opportunity to apply for grants to support clinical trials • Specialized regulatory assistance from FDA's Office of Orphan Products Develo

  23. Slide 23: LSTA1 capital efficient development plan; shared costs & selective geography

    LSTA1 capital efficient development plan; shared costs & selective geography 23 *Panitumumab may be added for colorectal or appendiceal patients without Ras mutation First-line mPDAC Gemcitabine/nab-paclitaxel with LSTA1 or placeboAGITG/Lisata Phase 2b (ASCEND) Placebo-controlled Enrolling Australia

  24. Slide 24: LSTA1 capital efficient development plan; shared costs & selective geography

    LSTA1 capital efficient development plan; shared costs & selective geography 24 Peritoneal Carcinomatosis (Colon & Ovarian) LSTA1 + HIPEC* intraoperative intraperitoneal lavage UCSD/Columbia University/Lisata Phase 1b/2a Open-label Pending initiation USA First-line Glioblastoma Multiforme (GBM) Temo

  25. Slide 25: Development Milestones

    Development Milestones

  26. Slide 26: A wealth of anticipated key milestones

    A wealth of anticipated key milestones 2Q 2023 3Q 2023 4Q 2023 1Q 2024 2Q 2024 3Q 2024 4Q 2024 1Q 2025 2Q 2025 3Q 2025 4Q 2025 1Q 2026 ASCEND [AUS, NZ] First-line mPDAC BOLSTER Trial [USA] Various solid tumors (Basket Trial) CENDIFOX [USA] Pancreatic, Colon and Appendiceal Cancers Qilu: Phase 1b/2a

  27. Slide 27: A wealth of anticipated key milestones (contd.)

    A wealth of anticipated key milestones (contd.) 2Q 2023 3Q 2023 4Q 2023 1Q 2024 2Q 2024 3Q 2024 4Q 2024 1Q 2025 2Q 2025 3Q 2025 4Q 2025 1Q 2026 Phase 2a [EST] First-line GBM Phase 1b/2a [USA] Peritoneal Carcinomatosis Qilu: Phase 2 [CHN] First-line mPDAC First patient in Last patient in Interim Anal

  28. Slide 28: Financial Highlights

    Financial Highlights 4 an

  29. Slide 29: Cash, debt and projected cash runway

    $54.4M Cash & Investments As of 9/30/2023 $0 Debt 1Q2026 Projected Cash Runway Into Common Shares Outstanding (9/30/2023): 8.1 million shares Options Outstanding (9/30/2023): Exercise Price: $0.02 - $4.22 = 1,082,000 shares Exercise Price: > $4.22 = 239,000 shares 1.3 million shares Warrants Outstan

  30. Slide 30: Strong Investment Rationale

    Strong Investment Rationale

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

    Key factors supporting investment in Lisata Therapeutics * As of 9/30/2023; includes investments PEOPLE Seasoned management with successful international development experience and expertise TECHNOLOGY Proprietary field- leading technology in underserved global indications MILESTONES Multiple projec

  32. Slide 32: Investor Relations Contact

    C o p y r i g h t © 2 0 2 3 L i s a t a T h e r a p e u t i c s , I n c . A l l r i g h t s r e s e r v e d . Targeted Therapy Delivered Investor Relations Contact: John D. Menditto VP, IR & Corporate Communications o: (908) 842-0084 | e: jmenditto@lisata.com Nasdaq: LSTA | www.lisata.com

  33. Slide 33: Appendix

    Appendix

  34. Slide 34: Development partners, indications and strategic rationale

    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 LSTA1 or placebo Phase 2b (ASCEND) Corroborate Phase 1b results in a placebo- controlled

  35. Slide 35: Development partners, indications and strategic rationale (contd.)

    Development Partner(s) [Development Venue] Indication and Trial Product/Comparator Stage of Development Strategic Rationale Tartu University/Lisata [Estonia] First-line Glioblastoma Multiforme; Temozolomide ± LSTA1 Phase 2a Assess LSTA1 safety and effectiveness in additional tumor type (GBM) a in pl

  36. Slide 36: ASCEND: Phase 2b, blinded, randomized trial in mPDAC

    ASCEND: Phase 2b, blinded, randomized trial in mPDAC 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 AUS) Objective

  37. Slide 37: ASCEND trial design

    R INTERVENTION Arm (N=60) • Nab-paclitaxel 125 mg/m2 IV • LSTA1 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 LSTA1 Placebo IV • Gemcitabine 1000 mg/m2 IV Dose on days 1, 8, 15 every 28 days INTERVENTION Arm (

  38. Slide 38: Phase 1b/2a open-label trial in mPDAC in China

    Sponsor/Partner  Qilu Pharmaceutical (funds all development in China) Objective  Evaluate safety, pharmacokinetics and preliminary efficacy of LSTA1 added to SoC in Chinese patients with mPDAC Design  Phase 1b/2a open-label study in advanced mPDAC patients of Chinese ethnicity testing SoC chemoth

  39. Slide 39: Phase 1b/2a open-label trial in mPDAC in China: design

    7 Day Safety Evaluation LSTA1 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 LSTA1 Day 1 Phase 1b/2a study evaluating the safety, pharmacokinetics, and preliminary efficacy of LSTA1 for injection in Chinese patients wit

  40. Slide 40: CENDIFOX trial overview

    Sponsor/Partner  University of Kansas Medical Center (Investigator initiated trial in U.S.)  KUCC funded; Lisata provides LSTA1 Objective  Evaluate the safety and therapeutic effect of LSTA1 in combination with neoadjuvant FOLFIRINOX-based therapies and an EGFR inhibitor for the treatment of panc

  41. Slide 41: CENDIFOX 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

  42. Slide 42: BOLSTER: Phase 2 blinded, randomized PoC trial in various cancers

    Sponsor/Partner  Lisata (U.S.) Objective  Evaluate the preliminary efficacy, safety and tolerability of LSTA1 in combination with standards of care in subjects with advanced solid tumors Design  Phase 2 randomized, double-blind, placebo-controlled, proof-of-concept trial in 2nd line head and neck

  43. Slide 43: BOLSTER trial design

    Dosed on Days 1, 8 every 21 days X 8 cycles Dosed every 21 days Dosed every 21 days Disease Progression Response rates Safety LSTA1 + paclitaxel Confirm Eligibility Informed Consent 2nd line Esophageal SCC (after failure on first line IO) Survival Analysis 72-hour run-in without SoC 72-hour run-in w

  44. Slide 44: Phase 2 blinded, placebo-controlled trial in mPDAC in China

    Sponsor/Partner  Qilu Pharmaceutical (funds all development in China) Objective  Further evaluate safety and therapeutic efficacy of LSTA1 when added to SoC in Chinese patients with mPDAC Design  Phase 2b, double-blind, placebo-controlled, randomized study evaluating LSTA1 + SoC (Qilu-produced na

  45. Slide 45: Phase 2 China trial design

    Days 1, 8, 15 and every 28 days Disease Progression Response rates PFS Safety Gemcitabine + Qilu produced nab-paclitaxel + LSTA1 3.2 mg/kg Confirm Eligibility Informed Consent 1:1 Survival AnalysismPDAC R Gemcitabine + Qilu produced nab-paclitaxel + placebo N=TBD N=TBD Phase 2b, double-blind, placeb

  46. Slide 46: iLSTA: Phase 1b/2a trial in locally advanced PDAC with chemo & IO

    iLSTA: Phase 1b/2a trial in locally advanced PDAC with chemo & 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-resec

  47. Slide 47: iLSTA trial design

    iLSTA: Phase 1b/2a trial in locally advanced PDAC with chemo & IO Cohort 2 Gemcitabine + nab-paclitaxel + LSTA1 N=5 Cohort 1 Gemcitabine + nab-paclitaxel N=5 Cohort 3 Durvalumab + Gemcitabine + nab-paclitaxel + LSTA1 N=10-20 12 weeks 8 weeks tumor burden assessments until 24 months or recurrence 12

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

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

  49. Slide 49: iGoLSTA trial design

    Cohort 2 FOLFIRINOX + LSTA1 N=5 Cohort 1 FOLFIRINOX N=5 Cohort 3 Nivolumab + FOLFIRINOX + LSTA1 N=10-20 12 weeks 8 weeks tumor burden assessments until 24 months or recurrence 12 month Follow-up Primary Endpoint 24 months Follow-up completion Biopsy Screening Biopsy Week 12 Tumor burden assessment a

  50. Slide 50: Phase 2a trial of LSTA1 with SoC in first-line GBM

    Sponsor/Partner  Tartu University Hospital (Investigator initiated trial in Estonia)  Lisata providing study drug and funding trial Objective  Evaluate safety, tolerability, and therapeutic effect of LSTA1 in combination with standard- of-care (temozolomide) in patients with previously untreated

  51. Slide 51: GBM Phase 2a trial design

    Days 1, 2, 3, 4, 5 and every 28 days for 6 cycles Disease Progression Response rates Safety Temodar® + LSTA1Confirm Eligibility Informed Consent 1:1 Survival Analysis 72-hour Run-in without SoC Newly Diagnosed GBM R Temodar® + LSTA1 matching placebo N=20 N=10 Phase 2a double-blind, placebo-controlle

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