Lisata Therapeutics, Inc. · NASDAQ:LSTA

Lisata Therapeutics — Caladrius Biosciences — Investor Presentation (March 2022)

33 slides from Lisata Therapeutics's investor presentation, Mar 22, 2022

  1. Slide 1: Developing Innovative Therapies that Treat or Reverse Disease

    David J. Mazzo, PhD President & Chief Executive Of ficer M a rc h 2 2 , 2 0 22| N a s d a q : C L B S Developing Innovative Therapies that Treat or Reverse Disease Exhibit 99.2

  2. Slide 2: Forward-looking statement

    This Investor Presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this presentation, and involve certain risks and uncertainties. All state

  3. Slide 3: Caladrius investment highlights

    CD34+ cell therapy platform yielding a multi-product development pipeline with 2 clinical programs having regenerative medicine “breakthrough” designation Proprietary field-leading technology in lucrative global indications backed by a strong IP portfolio Potential value creating events in the next

  4. Slide 4: CD34+ Cell Therapy Technology Overview

    CD34+ Cell Therapy Technology Overview

  5. Slide 5: CD34+ cells have a well characterized mechanism of action

     Naturally occurring endothelial progenitor cells that re-establish blood flow to under-perfused tissues1,2  Possess pre-programmed pro-angiogenic and anti-inflammatory tissue repair properties3,4 1Mackie, A.R. et al., Tex Heart Inst J 2011, 38(5), 474-485 2Kocher, A.A. et al., Nat Med 2001, 440-4

  6. Slide 6: CD34+ autologous cell therapy is extensively studied/clinically validated

     CD34+ cells have been studied clinically in a variety of ischemic disease indications by numerous investigators across many sites and countries  CD34+ cells repeatedly demonstrated vascular repair in multiple organs  Consistent and compelling results of rigorous clinical studies comprising >1,00

  7. Slide 7: Autologous CD34+ cell process is rapid/economical/scaled

     Drug induced mobilization eliminates need for surgical bone marrow aspiration  No genetic manipulation or ex vivo expansion of cells  Four days or less from donation to treatment Caladrius’ autologous CD34+ cell process is rapid/economical/scaled 7

  8. Slide 8: Autologous CD34 technology has robust intellectual property

    U.S. patents granted 9 28 Foreign patents granted Patent protection to 2031+ Key Patent Claims  Pharmaceutical composition of non-expanded CD34+/CXCR4+ cells  Therapeutic concentration range  Stabilizing serum  Repair of injury caused by vascular insufficiency Caladrius’ autologous CD34 technolo

  9. Slide 9: Caladrius' innovative autologous CD34+ cell therapy pipeline

    PRODUCT/INDICATION DEVELOPMENT STAGE XOWNA® (CLBS16) CORONARY MICROVASCULAR DYSFUNCTION FREEDOM PHASE 2B TRIAL (USA; ONGOING) Caladrius’ innovative autologous CD34+ cell therapy pipeline1,2 1 Products are distinct and not interchangeable 2 All timing subject to COVID-19 pandemic influence 9 HONEDRA®

  10. Slide 10: XOWNA (CLBS16) Coronary Microvascular Dysfunction (USA)

    XOWNA® (CLBS16) Coronary Microvascular Dysfunction (USA)

  11. Slide 11: Coronary microvascular dysfunction (CMD)

     Deficient heart microvasculature without large vessel obstructive disease  Causes frequent, debilitating chest pain; not treatable by stents or bypass; responds poorly or not at all to available pharmacotherapies  Afflicts women more frequently (2:1 to 3:1), especially younger women1,2  Results

  12. Slide 12: CMD represents a large unmet medical need

     ~112 million people globally are affected by angina1  ~8.3 million people in the U.S. suffering from coronary artery disease (CAD)2  10% - 30% of angina patients have no significant CAD on invasive coronary angiography3,4  50% - 65% of patients with angina without obstructive CAD are believed t

  13. Slide 13: ESCaPE-CMD: Phase 2a proof-of-concept trial completed

    Endpoints  Therapeutic effect and the evaluation of adverse events; including changes from baseline to 6 months for coronary flow reserve, angina frequency, CCS angina class, quality of life Study Size  20 subjects (U.S. centers - Cedars Sinai, Los Angeles & Mayo Clinic, Rochester) Dose  Up to 30

  14. Slide 14: ESCaPE-CMD: Durable, physiologic coronary vasculature improvement

    ESCaPE-CMD: Durable, physiologic coronary vasculature improvement 14 1 Murthy et al, Circulation, 2014 2 Henry, T. D., Bairey Merz, C. N., et al. (2022). Cardiovascular interventions. Coronary Flow Reserve 1 2.08 2.68 p = 0.0045 N=20 Pre-Treatment After 6 months N=19 Key Points:  Evaluated subjects

  15. Slide 15: ESCaPE-CMD: Durable, symptomatic anginal relief

    15 1 Henry, D. T., SCAI 2020 Scientific Sessions 2 Spertus, J.A. et al, JACC Vol. 25, No. 2 February 1995: 333-341 3 Henry, T. D., Bairey Merz, C. N., et al. (2022). Cardiovascular interventions. 0 20 40 60 80 100 Treatment Satisfaction Disease Perception Physical Limitation Angina Stability Angina

  16. Slide 16: FREEDOM trial: Phase 2b double-blind, placebo-controlled

    Endpoints  Change from baseline in angina frequency [Baseline to 3 and 6 months]  Change from baseline in total exercise time [Baseline to 6 months]  Change from baseline in health-related quality of life [Baseline to 3 and 6 months]  Change from baseline in peak coronary flow reserve [Baseline

  17. Slide 17: HONEDRA Critical Limb Ischemia (Japan) (CLBS12)

    SAKIGAKE designated – Japan Orphan Drug designated (Buerger’s disease) - USA Advanced Therapeutic Medicinal Product (ATMP) designated – EU HONEDRA® Critical Limb Ischemia (Japan) (CLBS12)

  18. Slide 18: Indication: Critical limb ischemia (CLI)

     Severe arterial obstruction impeding blood flow in the lower extremities  Often found as a co-morbidity in diabetes patients  Includes severe rest pain and non-healing ulcers  Buerger’s disease (BD = inflammation in small and medium arteries) a form of CLI associated with a history of heavy smo

  19. Slide 19: CLI: Higher mortality incidence than most cancers

    CLI: Higher mortality incidence than most cancers Mustapha, J. A., Katzen, B. T., et al. (2019, May). Endovascular Today, 18(5), 80-82 19 0 100000 200000 300000 0 10 20 30 40 50 60 70 80 90 No. Incident Cases in U.S. Death within 5 years (%) CLI

  20. Slide 20: HONEDRA targets patients based on the Rutherford Scale

    HONEDRA® targets patients with R4 or R5 disease 1 Reinecke H., European Heart Journal, 2015 Apr 14;36(15):932-8 HONEDRA® targets patients based on the Rutherford Scale 20 CLI amputation rates increase with increasing Rutherford score (disease severity)1 Rutherford (“R”) scale R 6: Functional foot no

  21. Slide 21: Single treatment of CD34+ cells reversed CLI

    Single treatment of CD34+ cells reversed CLI (Phase 2 data) 21 Post-treatment (week 12) Pre-treatment Actual CLI Patient Laser Doppler Image 0 14 28 42 57 71 Time (weeks) CLBS12 Placebo 75% 22% p = 0.014 106 cells/kg Probability of Amputation-Free Survival (USA; n=28)2 ~80% of patients achieved sust

  22. Slide 22: HONEDRA registration-eligible study (CLBS12-P01, Japan)

    Primary Endpoint  Time to continuous CLI-free (2 consecutive monthly visits, adjudicated independently) Target Study Size  35 (30 subjects with no-option CLI + 5 Buerger’s disease pts.); all Rutherford category 4 or 5; recruited across 12 centers in Japan Dose  Up to 106 cells/kg of HONEDRA® (CLB

  23. Slide 23: CLBS12-P01 full analysis set efficacy trends positively

     Proportion of CLBS12-treated subjects reaching CONTINUOUS CLI-free status MORE THAN DOUBLE control arm  Proportion of CLBS12-treated subjects reaching FIRST CLI-free status MORE THAN DOUBLE control arm CLBS12-P01 “full analysis set” efficacy trends positively 23FAS: Full Analysis Set as defined b

  24. Slide 24: CLBS12-P01 efficacy trends positively for both ASO and BD

    CLBS12-P01 efficacy trends positively for both ASO and BD individually 24FAS: Full Analysis Set as defined by Japanese Regulators (PMDA) Efficacy trends are consistent across both populations ASO Control ASO CLBS12 BD CLBS12 CLBS12(ASO+BD) Proportion of Subjects Reaching Pr op or tio n of S ub je ct

  25. Slide 25: HONEDRA development next steps

     HONEDRA® study enrollment was significantly curtailed by the impact of COVID-19 (States of Emergency in Japan between ~ February 2020 and October 2021)  Total enrolled to date: 33 (26 no-option CLI pts. + 7 Buerger’s disease pts.)  Combined CLI and BD interim data suggest trend toward efficacy a

  26. Slide 26: CLBS201 Diabetic Kidney Disease (USA)

    CLBS201 Diabetic Kidney Disease (USA)

  27. Slide 27: Chronic kidney disease: Risk factors and comorbidities

     Advancing age is a risk factor for chronic kidney disease (CKD). Type 2 diabetes and hypertension are common comorbidities  1 in 3 adults are type 2 diabetic and 1 in 5 adults are hypertensive1 Chronic kidney disease: Risk factors and comorbidities 1 Centers for Disease Control and Prevention. Ch

  28. Slide 28: CKD: Multiple stages progressing toward kidney failure

    CKD: Multiple stages progressing toward kidney failure 1 2020 Dallas Nephrology Associates 2 Centers for Disease Control and Prevention. Chronic Kidney Disease Surveillance System—United States.  The stages of CKD are determined by glomerular filtration rate (GFR)1  GFR is measured to determine ho

  29. Slide 29: Development rationale for CLBS201

     CKD is often associated with progressive microvasculature damage and loss1,2  Preclinical studies show that microcirculation replenishment improves kidney function  CD34+ cells are promoters of new capillary growth, improving the microvasculature  Therapies currently available and/or expected t

  30. Slide 30: CLBS201: Planned Phase 1 proof-of-concept study

    CLBS201: Planned Phase 1 proof-of-concept study 30 Endpoints  Change in eGFR compared to baseline, assessed at 6 months  Change in Urine albumin-to-creatinine ratio (UACR) and urine protein-to-creatinine ratio (UPCR) from baseline to 3 and 6 months Study Size  6 patients (1 sentinel - unilateral

  31. Slide 31: Caladrius key financial information

    Caladrius key financial information 31 Cash & Investments: As of December 31, 2021 $95.0 million Full year ended December 31, 2021 Operating Cash Burn1: $23.7 million Cash Runway Based on Current Plan: Sufficient capital to fund operations beyond multiple key data readouts (>2024) Debt as of Decembe

  32. Slide 32: Caladrius investment highlights

    CD34+ cell therapy platform yielding a multi-product development pipeline with 2 clinical programs having regenerative medicine “breakthrough” designation Proprietary field-leading technology in lucrative global indications backed by a strong IP portfolio Potential value creating events in the next

  33. Slide 33: Investor Relations Contact

    Developing Innovative Therapies that Treat or Reverse Disease Investor Relations Contact: John D. Menditto Tel: (908) 842-0084 jmenditto@caladrius.com M a rc h 2 2 , 2 0 22| N a s d a q : C L B S

Caladrius Biosciences — Investor Presentation (March 2022) on 6ix