Lisata Therapeutics, Inc. · NASDAQ:LSTA

Lisata Therapeutics — Investor Presentation (August 2023)

54 slides from Lisata Therapeutics's investor presentation, Aug 14, 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 David J. Mazzo, Ph.D. President and Chief Executive Officer Corporate Presentation | August 14, 2023 Nasdaq: LSTA www.lisata.com Exhibit 99.2

  2. Slide 2: Forward-looking Statements

    Forward-looking Statements 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, included in

  3. Slide 3: Company Overview

    Company Overview

  4. Slide 4: Lisata: Nasdaq-listed clinical stage therapeutics development company

    LISATA EUTICSTHERAP Nasdaq-listed clinical stage therapeutics development company with a novel solid tumor targeting and penetration technology to improve the efficacy of anti-cancer drugs 4 Lisata Therapeutics, Inc.

  5. Slide 5: Investment rationale – key company differentiation

    Investment rationale – key company differentiation 5 * As of 6/30/2023; includes investments $57.6 million cash*- no debt; Development funded through critical milestones Multiple projected product and business milestones over the next 24 months Seasoned management with successful drug development ex

  6. Slide 6: Experienced executive leadership team

    Experienced executive leadership team 6 David J. Mazzo, PhD President and Chief Executive Officer John Menditto VP of IR and Corporate Communications James Nisco VP of Finance and Treasury Kristen Buck, MD EVP of R&D and Chief Medical Officer Gregory Berkin VP of IT and Chief Informational Officer 6

  7. Slide 7: Lisata holds strong intellectual property portfolio for LSTA1

    Lisata holds strong intellectual property portfolio for LSTA1 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2040 2041 7 Orphan Drug Market Exclusivity + 3 yrs. in EU Composition of Matter Potential Patent Term Extension Composition of Matter Potential Patent Te

  8. Slide 8: Therapeutic Focus and Rationale

    Therapeutic Focus and Rationale

  9. Slide 9: Improved cancer treatment is a vital global need

    Improved cancer treatment is a vital global need 9 Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, or nearly one in six deaths1 – World Health Organization 1 www.who.int/news-room/fact-sheets/detail/cancer

  10. Slide 10: Solid tumor treatment is a large & growing market

    Solid tumor treatment is a large & growing market 1 CA A Cancer J Clinicians, Volume: 72, Issue: 1, Pages: 7-33, First published: 12 January 2022, DOI: (10.3322/caac.21708) 10 >1.9 million new cases of cancer will be diagnosed in 2022 In the U.S. alone, solid tumors account for >90% of new cancer ca

  11. Slide 11: Tumor targeting and intratumoral penetration are suboptimal

     Tumor targeting and intratumoral penetration are suboptimal • Tumor stroma acts as an effective barrier to anti-cancer agents • Tumor microenvironment immunosuppressive cells contribute to tumor resistance and/or metastases • Continued or escalated dosing of non-targeted anti-cancer therapy can le

  12. Slide 12: Lisata's CendR Platform promises optimized solid tumor treatment

    Lisata’s CendR Platform® promises optimized solid tumor treatment  Converts tumor stroma from barrier to conduit • Combination possible with most anti-cancer drugs • LSTA1 effectiveness agnostic to co-administered drug modality • Mechanism effective with co-administered or tethered anti-cancer ther

  13. Slide 13: LSTA1: lead clinical development candidate of the CendR Platform

    LSTA1: lead clinical development candidate of the CendR Platform®  Pursue rapid global registration in pancreatic cancer, initially in combination with gemcitabine/nab- paclitaxel standard-of-care • Phase 2b underway  Demonstrate LSTA1 effectiveness in combination with a variety of standard-of- ca

  14. Slide 14: Partnerships

    Partnerships Noteworthy existing relationships with the potential for many more

  15. Slide 15: 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

  16. Slide 16: LSTA1 Strong Scientific Foundation and Rationale

    LSTA1 Strong Scientific Foundation and Rationale

  17. Slide 17: LSTA1 Mechanism of Action: Steps 1 & 2 of 3

    αvβ3/β5 integrin LSTA1 (Furin & others) Protease Cleavage CendR Peptide Fragment Tumor Vascular Endothelial Cell Cell Nucleus 17  LSTA1: 9 amino acid cyclic peptide; high binding specificity and affinity to αvβ3/β5 integrins that are upregulated on: • Tumor vascular endothelium • Tumor cells  Once

  18. Slide 18: 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 Vascular Endothelial Cell Cell Nucleus Gap junction opening 18  The CendR fragment then binds with high affinity and selectivity to an adjacent rece

  19. Slide 19: 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. 19  Etching s

  20. Slide 20: 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. 20 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

  21. Slide 21: 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

  22. Slide 22: 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

  23. Slide 23: 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

  24. Slide 24: LSTA1 Clinical Development Portfolio

    LSTA1 Clinical Development Portfolio Fast Track and Orphan Drug designated (PDAC) - USA

  25. Slide 25: LSTA1 capital efficient development plan; shared costs & selective geography

    LSTA1 capital efficient development plan; shared costs & selective geography 25 *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

  26. Slide 26: LSTA1 capital efficient development plan; shared costs & selective geography

    LSTA1 capital efficient development plan; shared costs & selective geography 26 First-line Glioblastoma Multiforme (GBM) Temozolomide +/- LSTA1 Tartu University Lisata Phase 2a Placebo-controlled Pending initiation Estonia & Latvia Peritoneal Carcinomatosis (Colon & Ovarian) LSTA1 + HIPEC intraopera

  27. Slide 27: Development Milestones

    Development Milestones

  28. Slide 28: 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

  29. Slide 29: 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 Study Design TBD First patient in Last patien

  30. Slide 30: Financial Highlights

    Financial Highlights — | ye

  31. Slide 31: $57.6M Cash & Investments; cash runway into 1Q2026

    $57.6M Cash & Investments As of 6/30/2023 $0 Debt 1Q2026 Projected Cash Runway Into Common Shares Outstanding (6/30/2023): 8.1 million shares Options Outstanding (6/30/2023): Exercise Price: $0.02 - $4.22 = 1,078,000 shares Exercise Price: > $4.22 = 261,000 shares 1.3 million shares Warrants Outstan

  32. Slide 32: Strong Investment Rationale

    Strong Investment Rationale

  33. Slide 33: Investment rationale – key company differentiation

    Investment rationale – key company differentiation 33 * As of 6/30/2023; includes investments $57.6 million cash*- no debt; Development funded through critical milestones Multiple projected product and business milestones over the next 24 months Seasoned management with successful drug development e

  34. Slide 34: 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

  35. Slide 35: Appendix

    Appendix

  36. Slide 36: Development partners, indications and trial 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

  37. Slide 37: Development partners, indications and trial 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

  38. Slide 38: Legacy CD34+ cell therapy clinical trials (HONEDRA)

    3838 Sponsor [Development Venue] Indication and Trial Product/Comparator Stage of Development Strategic Rationale Lisata [Japan] Critical Limb Ischemia & Buerger's Disease; HONEDRA® (LSTA12) Registration Eligible Assess safety and efficacy of LSTA12 in a controlled trial vs. SoC alone in the context

  39. Slide 39: 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

  40. Slide 40: 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 (

  41. Slide 41: 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

  42. Slide 42: 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

  43. Slide 43: CENDIFOX trial: University of Kansas Medical Center

    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

  44. Slide 44: 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

  45. Slide 45: 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

  46. Slide 46: 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

  47. Slide 47: 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

  48. Slide 48: 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

  49. Slide 49: 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

  50. Slide 50: 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

  51. Slide 51: iGoLSTA: Phase 1b/2a trial in locally advanced GEAC

    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

  52. Slide 52: 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

  53. Slide 53: 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

  54. Slide 54: Phase 2a GBM 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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