Lisata Therapeutics, Inc. · NASDAQ:LSTA

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

37 slides from Lisata Therapeutics's merger presentation, May 5, 2022

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

    David J. Mazzo, PhD President & Chief Executive Of ficer M ay 5 , 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 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

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

    4 Creating a new diversified therapeutics company, well-positioned for growth Lisata Therapeutics (Nasdaq: LSTA) Caladrius is focused on the discovery, development and commercialization of therapies designed to reverse disease and promote the regeneration of damaged tissue. Cend Therapeutics is focu

  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 technology

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

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

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

  8. Slide 8: Lisata strategic rationale: Qilu partnership and 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: Lisata Therapeutics Combined Pipeline

    Lisata Therapeutics Combined Pipeline

  10. Slide 10: Lisata Therapeutics projected pipeline of novel product candidates

    Lisata Therapeutics projected pipeline of novel product candidates Product Indication Preclinical Phase 1 Phase 2 Phase 3 Cend Pipeline CEND-1 + gemcitabine/nab-paclitaxel First-Line mPDAC (Metastatic Pancreatic Ductal Adenocarcinoma)CEND-1 + SoC chemo + anti-PD(L)1 CEND-1 + FOLFIRINOX PDAC (Resecta

  11. Slide 11: Lisata Therapeutics anticipated milestones

    Lisata Therapeutics anticipated milestones 11 2022 2023 2024 Cend Pipeline Programs Caladrius Pipeline Programs CEND-1 Ph2 in mPDAC (Aus) initiation planned 2Q 2022 CEND-1 Ph1 in mPDAC + PD(L)1 initiation planned 4Q 2022 CEND-1 Ph1b/2 in mPDAC (Qilu; China) preliminary data expected 1H 2023 CEND-1 P

  12. Slide 12: CD34+ Cell Therapy Technology Overview

    CD34+ Cell Therapy Technology Overview

  13. Slide 13: 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

  14. Slide 14: 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

  15. Slide 15: Caladrius' 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 15

  16. Slide 16: XOWNA (CLBS16) Coronary Microvascular Dysfunction (USA)

    XOWNA® (CLBS16) Coronary Microvascular Dysfunction (USA)

  17. Slide 17: 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

  18. Slide 18: 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

  19. Slide 19: ESCaPE-CMD: Durable, physiologic coronary vasculature improvement

    ESCaPE-CMD: Durable, physiologic coronary vasculature improvement 19 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

  20. Slide 20: ESCaPE-CMD: Durable, symptomatic anginal relief

    20 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

  21. Slide 21: 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

  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 (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

  24. Slide 24: 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 24 CLI amputation rates increase with increasing Rutherford score (disease severity)1 Rutherford (“R”) scale R 6: Functional foot no

  25. Slide 25: 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

  26. Slide 26: 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

  27. Slide 27: 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 27FAS: Full Analysis Set as defined b

  28. Slide 28: CLBS12-P01 efficacy trends positively for both ASO and BD

    CLBS12-P01 efficacy trends positively for both ASO and BD individually 28FAS: 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

  29. Slide 29: 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 no-option CLI pts. + 7 Buerger’s disease pts.)  Combined CLI and BD interim data suggest trend toward efficacy a

  30. Slide 30: CLBS201 Diabetic Kidney Disease (USA)

    CLBS201 Diabetic Kidney Disease (USA)

  31. Slide 31: 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

  32. Slide 32: 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

  33. Slide 33: 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

  34. Slide 34: CLBS201: Planned Phase 2 proof-of-concept study

    CLBS201: Planned 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

  35. Slide 35: Caladrius key financial information

    Caladrius key financial information 35 Cash & Investments: As of March 31, 2022 $88.5 million Three months ended March 31, 2022 Operating Cash Burn1: $8.0 million Cash Runway Based on Current Plan: Sufficient capital for existing programs as well as our balance target at expected closing of merger w

  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 Potential value creating events in the next

  37. Slide 37: 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 ay 5 , 2 0 22| N a s d a q : C L B S

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