Lisata Therapeutics, Inc. · NASDAQ:LSTA

Lisata Therapeutics — Technical Presentation (2020)

16 slides from Lisata Therapeutics's technical presentation, 2020

  1. Slide 1: Autologous CD34 Cell Therapy for Coronary Microvascular Dysfunction (ESCaPE-CMD)

    AUTOLOGOUS CD34 CELL THERAPY FOR TREATMENT OF CORONARY MICROVASCULAR DYSFUNCTION IN PATIENTS WITH ANGINA AND NON- OBSTRUCTIVE CORONARY ARTERIES (ESCAPE-CMD) Timothy D. Henry, MD, FACC, MSCAI Medical Director, The Carl and Edyth Lindner Center for Research and Education The Christ Hospital, Cincinnat

  2. Slide 2: Disclosures

    DISCLOSURES ESCaPE CMD – Exploratory Study of CLBS16 in Patients with CMD This work was sponsored by Caladrius Biosciences, Inc. and by the National Heart, Lung and Blood Institute at the National Institutes of Health under SBIR Award R44HL135889.

  3. Slide 3: INOCA & Coronary Microvascular Dysfunction (CMD)

    INOCA (ISCHEMIA & NON-OBSTRUCTIVE CORONARY ARTERY DISEASE) & CORONARY MICROVASCULAR DYSFUNCTION (CMD)

  4. Slide 4: Background: Reduced Coronary Flow Reserve Associated with Increased Risk of MACE

    BACKGROUD: REDUCED CORONARY FLOW RESERVE IS ASSOCIATED WITH SIGNIFICANTLY INCREASE RISK OF MACE Coronary Flow Reserve 25% 4 P <0,0001 (CFR) 20% 4 P = 0.56 (gender) }crR<20 15% Male —— ¥ Female — = om 4 0% } CFR 22.0 5% 4 0% +4 T T 1 0 1 2 3 Years Murthy et al, Circulation, 2014 SCAI Society for Card

  5. Slide 5: CD34+ Background

    CD34+ BACKGROUND • Therapeutic potential of CD34 cell as naturally occurring endothelial progenitor discovered in 1997 • Preclinical models document natural ability of CD34 to stimulate microvascular angiogenesis in ischemic tissue • Clinical studies in No Option Refractory Disabling Angina, Critica

  6. Slide 6: CLBS16 Proof of Concept Study (ESCaPE-CMD)

    CLBS16 PROOF OF CONCEPT STUDY (ESCAPE-CMD) ▪Interventional, open label, proof-of-concept Design study in patients with coronary microvascular dysfunction (CMD) defined as CFR ≤ 2.5 ▪Safety and the evaluation of adverse events ▪Changes from baseline to 6 months for CFR, Endpoints coronary blood flow

  7. Slide 7: Inclusion and Exclusion Criteria

    ESCAPE-CMD INCLUSION AND EXCLUSION CRITERIA • Angina  3 times per week • No obstructive disease on coronary angiogram • Invasive intracoronary adenosine CFR ≤ 2.5 • Exclusions: • ACS/Myocardial infarction < 90 days • Significant valvular heart disease • LVEF < 40% • Requiring anticoagulation NCT035

  8. Slide 8: CLBS16 Manufacturing

    ESCAPE-CMD CLBS16 MANUFACTURING • GCSF-mobilized autologous CD34 cells in a formulation that maximizes function: • 5 days of GCSF 5 µg/kg • Apheresis • Selection CD34 cells (central processing) • Proprietary formulation for intracoronary infusion in 10 mL volume • Return to investigator within 48 hr

  9. Slide 9: Subject Demographics

    ESCAPE-CMD SUBJECT DEMOGRAPHICS Variable CLBS16 (n=20) Age (years), Mean ± SD 54.3 ± 12.7 < 65, n (%) 14 (70%)  65, n (%) 6 (30%) BMI (kg/m2), Mean ± SD 29.5 ± 7.3 Gender, n (%) Female 17 (85%) Male 3 (15%) Race, n (%) White 16 (80%) American Indian/Alaskan Native 1 (5%) Asian 2 (10%) Ethnicity, n

  10. Slide 10: ESCaPE-CMD Increases CFR at 6 Months in CMD

    ESCAPE-CMD INCREASES CFR AT 6 MONTHS IN CMD Baseline 6 months

  11. Slide 11: ESCaPE-CMD Increases CFR at 6 Months in CMD

    ESCAPE-CMD INCREASES CFR AT 6 MONTHS IN CMD

  12. Slide 12: ESCaPE-CMD Decreases Angina Frequency at 6 Months

    ESCAPE-CMD DECREASES ANGINA FREQUENCY AT 6 MONTHS

  13. Slide 13: ESCaPE-CMD Improves CCS Angina Class at 6 Months

    ESCAPE-CMD IMPROVES CCS ANGINA CLASS AT 6 MONTHS CCS angina class changes from baseline to month 6.

  14. Slide 14: ESCaPE-CMD Improves Seattle Angina Questionnaire Scores

    ESCAPE-CMD IMPROVES SEATTLE ANGINA QUESTIONNAIRE SCORES AT 6 MONTHS

  15. Slide 15: Serious Adverse Events

    SERIOUS ADVERSE EVENTS • Procedure related focal dissection with stent placement • No myocardial infarction or repeat revascularization • No cell related adverse events • No Mortality

  16. Slide 16: ESCaPE-CMD Conclusions

    ESCAPE-CMD CONCLUSIONS • First study of CD34 cell therapy for CMD • No evidence for cell related adverse events • We demonstrate significant: • Improvement in invasive Coronary Flow Reduction • Reduction in Angina frequency • Improvement in Angina Class • Improvement in all domains of the SAQ • Base

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