Lisata Therapeutics, Inc. · NASDAQ:LSTA
Lisata Therapeutics — Caladrius Biosciences — Investor Presentation (March 2020)
38 slides from Lisata Therapeutics's investor presentation, Mar 5, 2020
Slide 1: Advancing Restorative Therapies to Treat Ischemic Disease
Exhibit 99.2 Advancing Restorative Therapies to Treat Ischemic Disease David J. Mazzo, PhD President and Chief Executive Officer March 5, 2020 | Nasdaq: CLBS
Slide 2: Forward-looking statement
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 an
Slide 3: Presentation contents
Presentation contents � Investment case summary � Management team introduction � CD34+ cell therapy platform technology overview � Pipeline description and individual program summaries � Financial overview � Milestone timeline � Conclusion 3
Slide 4: Caladrius investment case summary
Caladrius investment case summary CD34+ cell therapy platform company with an advanced clinical pipeline with two programs with cell therapy “breakthrough” designation Proprietary field-leading technology in multi-billion dollar global indications backed by a strong IP portfolio Multiple potential v
Slide 5: Caladrius management team
Caladrius management team David J. Mazzo, PhD Douglas Losordo, MD Joseph Talamo, CPA Todd Girolamo, JD John Menditto President and EVP, Global Head of R&D and Senior VP and Senior VP, General Counsel Vice President, IR and Chief Executive Officer Chief Medical Officer Chief Financial Officer and Cor
Slide 6: Esteemed cardiovascular disease scientific advisory board
Esteemed cardiovascular disease scientific advisory board C. Noel Bairey Merz, MD C. Michael Gibson, MD Timothy Henry, MD Cedars-Sinai, Los Angeles Harvard Medical School The Christ Hospital, Cincinnati Thomas Povsic, MD, PhD Richard Schatz, MD Christopher White, MD Duke Clinical Research Institute
Slide 7: CD34+ cell therapy platform technology overview
CD34+ cell therapy platform technology overview
Slide 8: CD34+ cells have a well characterized mechanism of action
CD34+ cells have a well characterized mechanism of action Augmented microvasculature post-CD34+ cells treatment Normal microvasculature Compromised microvasculature Capillaries Capillaries Capillaries New Capillaries Artery Vein Artery Vein Artery Vein � Naturally occurring vascular repair (endothel
Slide 9: CD34+ cell therapy is extensively studied/clinically validated
CD34+ cell therapy is extensively studied/clinically validated � CD34+ cells were clinically studied in multiple ischemic disease indications by numerous investigators across many sites and countries � Consistent and compelling results of rigorous clinical studies comprising >1,000 patients have bee
Slide 10: Caladrius CD34 process is simple/fast/economical/scaled
Caladrius CD34 process is simple/fast/economical/scaled Sample collection via apheresis Isolation, concentration and Cells returned to same patient by after 5 days of GCSF mobilization formulation of CD34+/CXCR4+ cells injection; site indication dependent Day 1 Day 2 Day 3 or 4 Shipment Shipment or
Slide 11: Caladrius CD34 technology has robust intellectual property
Caladrius CD34 technology has robust intellectual property Fundamental protection to 2031+ 9 27 U.S. patents Foreign patents granted granted Key Claims � Pharmaceutical composition of non-expanded CD34+/CXCR4+ stem cells � Therapeutic concentration range � Stabilizing serum � Repair of injury caused
Slide 12: Caladrius' innovative CD34+ cell therapy pipeline
Caladrius’ innovative CD34+ cell therapy pipeline* Commercialization Product Indication Development Stage Target CLBS12 CLI Registration eligible trial (Japan; ongoing) 2021 CLBS16 CMD Phase 2 (USA; start target mid 2020) TBD CLBS14 NORDA Phase 3 confirmatory (USA; initiation pending funding) TBD CL
Slide 13: CLBS12 Critical Limb Ischemia (Japan)
CLBS12 Critical Limb Ischemia (Japan) SAKIGAKE designated – Japan Advanced Therapeutic Medicinal Product (ATMP) designated - EU
Slide 14: Indication: Critical Limb Ischemia (CLI)
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) also causes CLI;
Slide 15: CLI: higher mortality rate than most cancers
CLI: higher mortality rate than most cancers 90 80 70 60 CLI 50 Death within 5 years (%) 40 30 20 10 0 0 100000 200000 300000 No. Incident Cases in U.S. Mustapha, J. A., Katzen, B. T., et al. (2019, May). Endovascular Today, 18(5), 80-82 15
Slide 16: CLI amputation rates increase with disease severity
CLI amputation rates increase with disease severity1 Rutherford (“R”) scale R 6: Functional foot no longer salvageable R 5: Minor tissue loss non-healing ulcer; focal gangrene with diffuse pedal ischemia CLBS12 targets patients with R4 or R5 disease R 4: Debilitating rest pain R 1-3: CLI-free 1 Rein
Slide 17: Single treatment of CD34+ cells reversed CLI
Single treatment of CD34+ cells reversed CLI Actual CLI Patient Laser Doppler Image % of Patients (CLI + BD) Achieving CLI-free Status 90% Pre-treatment Post-treatment (week 12) 85% 85% 80% 82% 70% 60% 40% 0 4 8 12 24 52 104 156 208 Time (weeks) ~80% of patients achieved sustainable remission within
Slide 18: Single treatment of CD34+ cells increased amputation-free survival
Single treatment of CD34+ cells increased amputation-free survival Probability of amputation-free (n=28) CLBS12 75% 106 cells/kg p = 0.014 Placebo 22% 0 14 28 42 57 71 Time (weeks) Losordo, D.W. et al, Circulation 2012; 5(6):821-830 18
Slide 19: CLBS12 registration-eligible study (Japan)
CLBS12 registration-eligible study (Japan) Primary Endpoint � Continuous CLI-free (2 consecutive monthly visits, adjudicated independently) � 30 subjects with no-option CLI + 7 Buerger’s Disease pts.; all R4 or R5; Study Size 12 centers in Japan Dose � 106 cells/kg (CLBS12) per affected limb (studie
Slide 20: Extraordinary CLBS12 results in Buerger's Disease (Japan)
Extraordinary CLBS12 results in Buerger’s Disease (Japan) Current Patient CLI Status (cohort completed; clinical primary endpoint met) Pre 1 30 60 90 120 150 180 210 240 270 300 330 365 (end) Rutherford 4 or 5 Rutherford 6 CLI-free Continuous CLI-free Amputation � Natural evolution of Buerger’s Dise
Slide 21: CLBS16 Coronary Microvascular Dysfunction (USA)
CLBS16 Coronary Microvascular Dysfunction (USA)
Slide 22: Heart disease: still a major unmet medical need globally
Heart disease: still a major unmet medical need globally 2017 2011 ISCHEMIA Trial3 results validate the need for HeartHeart Disease Disease treatments that go beyond large vessel All Cancers interventions Accidents � The International Study of Comparative Health Effectiveness with Medical and Invasi
Slide 23: Indication: Coronary Microvascular Dysfunction (CMD)
Indication: Coronary Microvascular Dysfunction (CMD) � Deficient heart microvasculature without obstructive vessel disease � Causes frequent, debilitating chest pain that is not treatable by stents or bypass; responds poorly or not at all to available medications � Afflicts women more frequently, es
Slide 24: ESCaPE-CMD: CLBS16 interventional, proof-of-concept trial
ESCaPE-CMD: CLBS16 interventional, proof-of-concept trial � Therapeutic effect and the evaluation of adverse events; including changes Endpoints from baseline to 6 months for coronary flow reserve, endothelial-dependent microvascular function, time to angina; other CV metrics Study Size � 20 subject
Slide 25: CLBS16 ESCaPE-CMD results are unique and compelling
CLBS16 ESCaPE-CMD results are unique and compelling Coronary Flow Reserve (17/20 subjects reporting) p = 0.0087 � CFR≤2.5 indicates CMD 2.61 2.08 � CFR≥2.5 is in “normal” range � Results after a single intracoronary administration of CLBS16 N=20 N=17 Pre-Treatment After 6 months Bairey Merz, C. N.,
Slide 26: CLBS16 ESCaPE-CMD results are unique and compelling
CLBS16 ESCaPE-CMD results are unique and compelling Seattle Angina Questionnaire Score (17/20 subjects reporting) Baseline 6 months Higher scores indicate improvement1 Angina Frequency p = 0.0143 Angina Stability p = 0.0425 Physical Limitation p = 0.002 Disease Perception p = 0.0005 Treatment Satisf
Slide 27: ESCaPE-CMD CLBS16 reported results summary
ESCaPE-CMD CLBS16 reported results summary � Statistically significant improvement in heart function and symptoms � First therapy to show the ability to durably increase CFR and potentially reverse CMD after a single administration � No evidence of cell related adverse events � Expected to lead to a
Slide 28: CLBS14 No Option Refractory Disabling Angina (USA)
CLBS14 No Option Refractory Disabling Angina (USA) Regenerative Medicine Advanced Therapy (RMAT) designated - USA
Slide 29: Indication: No Option Refractory Disabling Angina (NORDA)
Indication: No Option Refractory Disabling Angina (NORDA) � Recurring angina results from chronically impaired cardiac blood supply � The condition persists even after bypass surgery, angioplasty, stenting and available pharmacotherapy; no current treatment options � NORDA patients experience very f
Slide 30: Our solution: CLBS14
Our solution: CLBS14 � Clinical data from double-blind, randomized, placebo-controlled clinical trials, including big pharma sponsored Phase 2 and partial Phase 31,2,3,4,5 � Published results demonstrate: � Statistically significant improvement in exercise capacity � Statistically significant reduct
Slide 31: CLBS14 single treatment significantly improved exercise time
CLBS14 single treatment significantly improved exercise time Change in Exercise Time from Baseline (Phase 2, n=168) *6 months: CLBS14 (105 cells/kg) 139 sec p=0.014 Placebo 69 sec 12 months: CLBS14 (105 cells/kg) 140 sec p=0.017 Placebo 58 sec *Change in exercise time from baseline at 6 months will
Slide 32: CLBS14 single treatment significantly reduced angina frequency
CLBS14 single treatment significantly reduced angina frequency Reduction in Weekly Angina Frequency from Baseline (Phase 2, n=168) 6 months: CLBS14 (105 cells/kg) 13.8 p=0.0421 Placebo 8.8 12 months: CLBS14 (105 cells/kg) 15.3 p=0.0109 Placebo 8.7 32
Slide 33: CLBS14 single treatment significantly improved survival
CLBS14 single treatment significantly improved survival Mortality (Phase 2, n=168) Placebo 10% p = 0.0065 CLBS14 2.5% (105 cells/kg) 0 12 24 Time (months) 33
Slide 34: CLBS14 Phase 3 confirmatory registration study (U.S.)
CLBS14 Phase 3 confirmatory registration study (U.S.) Primary Endpoint � Change in exercise time from baseline at month 6 (studied in Phase 2) � 39 months from first-patient-in to top-line data; interim analysis after 50% of Timing patients complete 6-month follow-up � ~400 subjects (~200 active, ~1
Slide 35: Caladrius timeline of key development milestones
Caladrius timeline of key development milestones Program 2020 2021 Target Enrollment J-NDA Rolling Submission Top-line Data Target – Earliest possible approval Completion by Initiation Target – End 2020/Early 2021 in Japan 2H 2021 End of 1Q 2020 2H 2020 CLBS12 (CLI) Present Full ESCaPE-CMD Initiatio
Slide 36: Caladrius key financial information
Caladrius key financial information Cash & Investments as of December 31, 2019: $25.2 million Twelve Months Ended December 31, 2019 Operating Cash Burn: $18.9 million Cash Runway Based on Current Plan: through 2Q 2021 Debt: $0 Common Shares Outstanding as of December 31, 2019: 10.5 million shares Op
Slide 37: Caladrius investment case summary
Caladrius investment case summary CD34+ cell therapy platform company with an advanced clinical pipeline with two programs with cell therapy “breakthrough” designation Proprietary field-leading technology in multi-billion dollar global indications backed by a strong IP portfolio Multiple potential v
Slide 38: Thank you!
Thank you! Investor Relations Contact: John D. Menditto Tel: (908) 842-0084 jmenditto@caladrius.com March 5, 2020 | Nasdaq: CLBS
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