Lisata Therapeutics, Inc. · NASDAQ:LSTA

Lisata Therapeutics — Caladrius Biosciences — Investor Presentation (May 2021)

37 slides from Lisata Therapeutics's investor presentation, May 6, 2021

  1. Slide 1: Developing Regenerative Therapies that Reverse Chronic Disease

    David J. Mazzo, PhD President & Chief Executive Of ficer Developing Regenerative Therapies that Reverse Chronic Disease M ay 6 , 2 0 21 | N a s d a q : C L B S 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 Multiple potential value creating events in

  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+ 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: Caladrius' 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’ CD34+ cell process is rapid/economical/scaled 7 GCSF-induced mobilization of patient’s CD34+ cells from th

  8. Slide 8: Caladrius' CD34 technology has robust intellectual property

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

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

    PRODUCT/INDICATION DEVELOPMENT STAGE KEY MILESTONE TARGETS CLBS16 CORONARY MICROVASCULAR DYSFUNCTION FREEDOM PHASE 2B TRIAL (USA; ONGOING) - Complete enrollment: 4Q2021 - Top-line data: 3Q2022 Caladrius’ innovative CD34+ cell therapy pipeline1,2 1 Products are distinct and not interchangeable 2 Timi

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

    CLBS16 Coronary Microvascular Dysfunction (USA)

  11. Slide 11: CD34+ cell therapy targets unmet needs in cardiovascular diseases

    CD34+ cell therapy targets unmet needs in cardiovascular diseases 1 Centers for Disease Control and Prevention as cited in McKay, Betsy. "Heart-Failure Deaths Rise, Contributing to Worsening Life Expectancy." The Wall Street Journal, 30 Oct. 2019, Link to article. 2 Kochanek, KD., et al. (2016). Dea

  12. Slide 12: Coronary microvascular dysfunction overview

     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

  13. Slide 13: 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

  14. Slide 14: ESCaPE-CMD: Phase 2a interventional, proof-of-concept trial

    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

  15. Slide 15: CLBS16 ESCaPE-CMD results are unique and compelling

    CLBS16 ESCaPE-CMD results are unique and compelling 151 Murthy et al, Circulation, 2014 2 Henry, D. T., SCAI 2020 Scientific Sessions Daily Angina Frequency 2 4.42 2.02 N=20 Pre-Treatment After 6 months p = 0.0036 N=19 Coronary Flow Reserve 1 2.08 2.68 p = 0.0045 N=20 Pre-Treatment After 6 months N=

  16. Slide 16: CLBS16 ESCaPE-CMD results are unique and compelling

    0 20 40 60 80 100 Treatment Satisfaction Disease Perception Physical Limitation Angina Stability Angina Frequency Seattle Angina Questionnaire Score1 Baseline 6 months p = 0.0117 16 CLBS16 ESCaPE-CMD results are unique and compelling 1 Henry, D. T., SCAI 2020 Scientific Sessions 2 Spertus, J.A. et a

  17. Slide 17: CLBS16: ESCaPE-CMD summary

    CLBS16: ESCaPE-CMD summary 17  Statistically significant improvement in heart function and symptoms  No evidence of cell related adverse events  First therapy to potentially reverse CMD after a single administration; a potential breakthrough in the treatment of CMD  Expected to lead to a decreas

  18. Slide 18: 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

  19. Slide 19: 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)

  20. Slide 20: 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 (inflammation in small and medium arteries) a form of CLI associated with a history of heavy smoking

  21. Slide 21: CLI: higher mortality rate and incidence than most cancers

    CLI: higher mortality rate and incidence than most cancers Mustapha, J. A., Katzen, B. T., et al. (2019, May). Endovascular Today, 18(5), 80-82 21 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

  22. Slide 22: 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 22 CLI amputation rates increase with increasing Rutherford score (disease severity)1 Rutherford (“R”) scale R 6: Functional foot no

  23. Slide 23: Single treatment of CD34+ cells reversed CLI

    Single treatment of CD34+ cells reversed CLI (Phase 2 data) 23 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

  24. Slide 24: HONEDRA registration-eligible study (Japan)

    Primary Endpoint  Continuous CLI-free (2 consecutive monthly visits, adjudicated independently) Study Size  30 subjects with no-option CLI + 7 Buerger’s disease pts.; all Rutherford category 4 or 5; recruited across 12 centers in Japan Dose  Up to 10 6 cells/kg of HONEDRA® (CLBS12) to the most se

  25. Slide 25: Extraordinary HONEDRA results in Buerger's disease (JPN)

     Surgery not viable; existing pharmacotherapies do not prevent amputation1  Cohort enrollment complete  Results will contribute to the efficacy evaluation of the full study population Extraordinary HONEDRA® results in Buerger’s disease (JPN) 25 Approximately 60% of patients achieved CLI-free stat

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

    CLBS201 Diabetic Kidney Disease (USA)

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

     An aging population is at greatest risk of chronic kidney disease (CKD) with diabetes and hypertension being typical comorbidities  1 in 3 adults are diabetic and 1 in 5 adults are hypertensive Chronic kidney disease: risk factors and comorbidities Centers for Disease Control and Prevention. Chro

  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 th

  29. Slide 29: Scientific rationale for CLBS201 trial

     CKD is often associated with progressive microvasculature damage and loss, resulting from its common comorbidities of hypertension and diabetes1  The pathophysiology of CKD denotes compromised renal microvasculature2  Preclinical studies show that microcirculation replenishment improves kidney f

  30. Slide 30: CLBS201: Planned Phase 2 proof-of-concept study

    CLBS201: Planned Phase 2 proof-of-concept study 30 Primary Endpoint  Change in eGFR compared to baseline, assessed at 6 months Study Size  ~40 subjects (stage 3 diabetic kidney disease) Dose  1x106 - 300x106 cells, half per kidney, administered as a one-time infusion Design  Placebo-controlled w

  31. Slide 31: OLOGO (CLBS14) No-Option Refractory Disabling Angina (USA)

    OLOGO™ (CLBS14) No-Option Refractory Disabling Angina (USA) Regenerative Medicine Advanced Therapy (RMAT) designated - USA

  32. Slide 32: Refractory disabling angina and prior clinical data

     Recurring angina results from chronically impaired cardiac blood supply  Persists even after bypass surgery, angioplasty, stenting and pharmacotherapy; no current treatment  NORDA patients experience very frequent disabling chest pain at rest or with minimal activity  Cardiac microcirculation d

  33. Slide 33: Planned Phase 3 study design

    Primary Endpoint  Change in exercise time from baseline at month 6 (studied in Phase 2) Study Size  ~400 subjects (~200 active, ~150 placebo, ~50 SOC with cross-over to open label treatment at 6 months) Dose  105 cells/kg body weight (studied in Phase 2) Control/Comparator  Placebo control (blin

  34. Slide 34: Caladrius timeline of key development milestones

    2020 2021 2022 Caladrius timeline of key development milestones* * Timing subject to COVID-19 pandemic influence 34 OLOGO™ (CLBS14) NO-OPTION REFRACTORY DISABLING ANGINA Development Continuation: Pending FDA Discussions HONEDRA® (CLBS12) Registration Eligible Study Enrollment Completion: 2021 CRITIC

  35. Slide 35: Caladrius key financial information

    Caladrius key financial information 35 Cash & Investments: As of March 31, 2021 ~$112 million Three months ended March 31, 2021 Operating Cash Burn: $8.0 million Cash Runway Based on Current Plan: Sufficient capital to fund operations beyond multiple key data readouts (>2023) Debt as of March 31, 20

  36. Slide 36: 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 Multiple potential value creating events in

  37. Slide 37: Investor Relations Contact

    Developing Regenerative Therapies that Reverse Chronic Disease Investor Relations Contact: John D. Menditto Tel: (908) 842-0084 jmenditto@caladrius.com M ay 6 , 2 0 21 | N a s d a q : C L B S

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