Lisata Therapeutics, Inc. · NASDAQ:LSTA

Lisata Therapeutics — Caladrius Biosciences — Merger or Acquisition (August 2022)

42 slides from Lisata Therapeutics's merger presentation, Aug 5, 2022

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

    David J. Mazzo, PhD President & Chief Executive Of ficer Au g u s t 4 , 2 0 2 2| N a s d a q : C L B S Developing Innovative Therapies that Treat or Reverse Disease Exhibit 99.3

  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: Caladrius investment highlights

    Combination of Caladrius and Cend platforms expected to provide Lisata with a multi-product development pipeline Proprietary field-leading technology in lucrative global indications backed by a strong IP portfolio Potential value creating events in the next 12-24 months based on milestones across th

  4. Slide 4: Creating a new diversified therapeutics company, well-positioned for growth

    4 Creating a new diversified therapeutics company, well-positioned for growth LISATA EUTICSTHERAP (Nasdaq: LSTA) Merger expected to close fall 2022  Lisata is derived from the Finnish for “augmented” or “enhanced”  Public company with diverse development pipeline, strong existing & potential for f

  5. Slide 5: Lisata Therapeutics overview

    Lisata Therapeutics overview  Experienced Executive and Development Leadership with extensive domain-relevant expertise  David J. Mazzo, Ph.D. – Chief Executive Officer  David Slack, M.B.A. – President and Chief Business Officer  Kristen K. Buck, M.D. – Executive Vice President of R&D and Chief

  6. Slide 6: Lisata Therapeutics strategic rationale: proprietary platform technologies

    Lisata Therapeutics strategic rationale 6 CendR Platform™ provides a targeted tissue penetration capability designed to specifically enhance drug delivery to solid tumors  Converts tumor stroma from barrier to conduit for effective delivery via co-administration of a range of chemo-, targeted and i

  7. Slide 7: Lisata strategic rationale: robust clinical stage pipeline

    Lisata Therapeutics strategic rationale 7 Lead product candidate, CEND-1, advancing in a variety of difficult-to-treat solid tumor applications  CEND-1 is currently in multiple studies in first-line, metastatic pancreatic ductal adenocarcinoma (mPDAC) in combination with standard-of-care chemothera

  8. Slide 8: Lisata strategic rationale: compelling value proposition

    Lisata Therapeutics strategic rationale  Existing Cend strategic partnership in China with Qilu Pharmaceutical with non-dilutive milestone payments, development collaboration, and participation in downstream economics  Potential for up to $225 million in milestones and royalties on potential sales

  9. Slide 9: Pipeline of CendR and CD34+ programs

    Sponsor/Funding Institution Trial Products Indication Preclinical Phase 1 Phase 2 Phase 3 CendR Programs Lisata (U.S.) Ph2/3 adaptive Gemcitabine/nab-paclitaxel ± CEND-1 First-Line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) SWOG - NCI (U.S.) Ph2/3 FOLFIRINOX ± CEND-1 AGITG (Aus) Ph2b Gemcit

  10. Slide 10: CD34+ Cell Therapy Technology Overview

    CD34+ Cell Therapy Technology Overview

  11. Slide 11: 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

  12. Slide 12: CD34+ cells studied clinically in a variety of ischemic disease indications

     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

  13. Slide 13: Caladrius' autologous CD34+ cell process is rapid, economical and 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 13

  14. Slide 14: XOWNA (CLBS16) Coronary Microvascular Dysfunction (USA)

    XOWNA® (CLBS16) Coronary Microvascular Dysfunction (USA)

  15. Slide 15: Coronary microvascular dysfunction disease 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

  16. Slide 16: 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

  17. Slide 17: ESCaPE-CMD: Durable, physiologic coronary vasculature improvement

    ESCaPE-CMD: Durable, physiologic coronary vasculature improvement 17 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

  18. Slide 18: ESCaPE-CMD: Durable, symptomatic anginal relief

    18 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

  19. Slide 19: 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

  20. Slide 20: XOWNA/FREEDOM Trial status update

    XOWNA®/FREEDOM Trial status update  Enrollment discontinued at ~1/3 of 105 originally stipulated patients due to COVID-19 pandemic related delays and other challenges, including:  Restricted accessibility of subjects to investigational sites  Reduced availability of staff at the clinical sites 

  21. Slide 21: XOWNA/FREEDOM Trial status update (cont.)

    XOWNA®/FREEDOM Trial status update (cont.)  Additional clinical data are not particularly useful for future regulatory and/or commercial use  Revised projected recruitment timeline of >4 years to trial primary endpoint readout not viable for financial and commercial reasons  Planned interim analy

  22. Slide 22: 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)

  23. Slide 23: Indication: Critical limb ischemia

     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

  24. Slide 24: Single treatment of CD34+ cells reversed CLI

    Single treatment of CD34+ cells reversed CLI (Phase 2 data) 25 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

  25. Slide 25: 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 (ASO) + 5 Buerger’s disease (BD) pts.); all Rutherford category 4 or 5; recruited across 12 centers in Japan Dose  Up to 106 cells/kg of HO

  26. Slide 26: CLBS12-P01: Treated subjects reach primary endpoint sooner

    25% of CLBS12-treated subjects (ASO+BD) reached CONTINUOUS CLI-free status ~232 days sooner than 25% of subjects in the control arm CLBS12-P01: Treated subjects reach primary endpoint sooner 27 15 13 11 9 6 6 5 5 0CLBS12 14 12 8 7 7 6 6 3 1Control Control CLBS12 0 50 100 150 200 250 300 350 400 Days

  27. Slide 27: CLBS12-P01: Treated subjects hit secondary endpoint sooner

    CLBS12-P01: Treated subjects hit secondary endpoint sooner 28 25% of CLBS12-treated subjects (ASO+BD) reached FIRST CLI-free status ~260 days sooner than 25% of subjects in the control arm 15 13 10 9 6 6 5 5 0CLBS12 14 12 7 6 6 5 5 3 1Control Control CLBS12 0 50 100 150 200 250 300 350 400 Days 0 10

  28. Slide 28: HONEDRA study enrollment curtailed by COVID-19

     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 ASO pts. + 7 BD pts. vs. planned 30 ASO pts. + 5 BD pts.)  Combined CLI and BD interim data suggest trend toward

  29. Slide 29: CLBS201 Diabetic Kidney Disease (USA)

    CLBS201 Diabetic Kidney Disease (USA)

  30. Slide 30: 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

  31. Slide 31: 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

  32. Slide 32: 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

  33. Slide 33: CLBS201: Phase 1 proof-of-concept study

    CLBS201: Phase 1 proof-of-concept study 34 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 inj., 1

  34. Slide 34: Emphasizing the development of more effective treatments for solid tumors

    Emphasizing the development of more effective treatments for solid tumors LISATA EUTICSTHERAP

  35. Slide 35: CEND-1 (iRGD) mechanism of action

    CEND-1 (iRGD) mechanism of action  CEND-1, a cyclic peptide, targets tumors by binding to alpha-v (“αv”) integrins, which are selectively expressed on tumor vascular endothelium and not expressed on normal healthy vasculature  αv integrins are also expressed on:  Cancer-associated fibroblasts, a

  36. Slide 36: CEND-1 (iRGD) mechanism of action: part 1

    CEND-1 (iRGD) mechanism of action: part 1 37 αv β3/β5 Tumor Vascular Endothelial Cell Co- Admin Drug or Cargo Integrin CEND-1 Protease Peptide Cleaved  CEND-1 targets tumor alpha-v integrins, which are selectively expressed on tumor vascular endothelium and not expressed on normal healthy vasculatu

  37. Slide 37: CEND-1 (iRGD) mechanism of action: part 2

    CEND-1 (iRGD) mechanism of action: part 2 Neuropilin-1 Receptor Tumor Vascular Endothelial Cell CendR Peptide Fragment Co-administered Anti-cancer therapy CendR Pathway  CendR peptide binds to Neuropilin-1 to activate CendR Pathway  CendR Pathway enables bound and/or co-administered drugs to penet

  38. Slide 38: Pipeline of CendR and CD34+ programs

    Sponsor/Funding Institution Trial Products Indication Preclinical Phase 1 Phase 2 Phase 3 CendR Programs Lisata (U.S.) Ph2/3 adaptive Gemcitabine/nab-paclitaxel ± CEND-1 First-Line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) SWOG - NCI (U.S.) Ph2/3 FOLFIRINOX ± CEND-1 AGITG (Aus) Ph2b Gemcit

  39. Slide 39: Lisata Therapeutics anticipated milestones

    Lisata Therapeutics anticipated milestones 40 2022 2023 2024 CEND-1 Ph2b in mPDAC (Aus) initiated 2Q 2022 CEND-1 Ph1b/2 in mPDAC + PD(L)1 initiation 4Q 2022 CEND-1 Ph1b/2 in mPDAC (Qilu; China) preliminary data target 1H 2023 CEND-1 Ph2a solid tumor basket trial initiation 2023 TPN development candi

  40. Slide 40: Caladrius key financial information

    Caladrius key financial information 41 Cash & Investments1: As of June 30, 2022 $73.0 million Six months ended June 30, 2022, Operating Cash Burn2: $13.0 million Cash Runway Based on Current Plan: Sufficient capital for existing programs as well as our balance target at expected closing of merger wi

  41. Slide 41: Caladrius investment highlights

    Combination of Caladrius and Cend platforms expected to provide Lisata with a multi-product development pipeline Proprietary field-leading technology in lucrative global indications backed by a strong IP portfolio Potential value creating events in the next 12-24 months based on milestones across th

  42. Slide 42: Investor Relations Contact

    Developing Innovative Therapies that Treat or Reverse Disease Investor Relations Contact: John D. Menditto Tel: (908) 842-0084 jmenditto@caladrius.com Au g u s t 4 , 2 0 2 2| N a s d a q : C L B S

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