Lisata Therapeutics, Inc. · NASDAQ:LSTA
Lisata Therapeutics — Caladrius Biosciences — Investor Presentation (November 2019)
38 slides from Lisata Therapeutics's investor presentation, Nov 18, 2019
Slide 1: Advancing Restorative Therapies to Treat Ischemic Disease
Advancing Restorative Therapies to Treat Ischemic Disease David J. Mazzo, PhD President and Chief Executive Officer November 2019 | 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, Joseph Talamo, Todd Girolamo, JD John Menditto President and MD CPA Senior VP, General Counsel Vice President, IR and and Corporate Secretary Corporate Communications Chief Executive Officer EVP, Global Head of R&D Senior VP and and Chie
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 been
Slide 10: Caladrius CD34 process is simple/fast/scalable/economical
Caladrius CD34 process is simple/fast/scalable/economicalSample collection via apheresis Isolation, concentration and Cells returned to same patient by after 5 days of GCSF formulation of CD34+/CXCR4+ injection; site indication mobilization cells 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 23 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 Phase 2 (Japan; ongoing) 2021 CLBS16 CMD Proof-of-concept (USA; ongoing) TBD Phase 3 confirmatory (USA; initiation pending CLBS14 NORDA TBD funding) CLI =
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 50 Death within 5 40 years (%) 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 R 4: Debilitating rest pain disease 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- 18 830
Slide 19: CLBS12 registration-eligible study (Japan)
CLBS12 registration-eligible study (Japan) . Continuous CLI-free (2 consecutive monthly visits, adjudicated Primary Endpoint independently) . 30 subjects with no-option CLI + 5 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 (n=6; study on-going) (Follow-up ongoing) (Follow-up ongoing) A Pre 1 30 60 90 120 150 180 210 240 270 300 330 365 Time (days) Continuous CLI- Rutherford 4 or 5 Rutherford 6 CLI-free Amputation (A) free . Natural ev
Slide 21: CLBS16 Coronary Microvascular Dysfunction (USA)
CLBS16 Coronary Microvascular Dysfunction (USA)
Slide 22: Heart disease: No. cause of death in the U.S. and growing
Heart disease: No. 1 cause of death in the U.S. and growing Number of deaths by leading causes Thousands 2011 2017 700 600 500 400 300 200 100 0 HeartHeart Disease Cancer AccidentsLower Respiratory disease Stroke Alzheimer's Diabetes Influenza and PneumoniaKidney failure Suicide Disease Source: Cent
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 . 20 subjects (U.S. cen
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 N=20 N=17 of CLBS16 Pre-Treatment After 6 months Bairey Merz, C. N.,
Slide 26: CLBS16 ESCaPE-CMD results: Seattle Angina Questionnaire
CLBS16 ESCaPE-CMD results are unique and compelling Seattle Angina Questionnaire Score (17/20 subjects reporting) Baseline 6 months Angina Frequency p = 0.0143 Angina Stability p = 0.0425 Physical Limitation p = 0.002 Disease Perception p = 0.0005 Treatment Satisfaction p = 0.0044 0 20 40 60 80 100
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 fr
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) 012 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% Timing of 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 2019 2020 Target Enrollment Registration Eligible Completion by Top-line Data Target – End of 1Q 2020 End of 2020 CLBS1 2 (CLI) Phase 2 Clinical Trial AHA Presentation of Complete Top-line Data Initiation of Phase 2 Trial Enrollment Completed
Slide 36: Caladrius key financial information
Caladrius key financial information Cash & Investments as of September 30, 2019: $29.2 million Nine Months Ended September 30, 2019 Operating Cash $14.7 million Burn: Cash Runway Based on Current Plan: Through 1Q 2021 Debt: $0 Common Shares Outstanding as of September 30, 2019: 10.4 million shares O
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 Email: jmenditto@caladrius.com November 2019 | Nasdaq: CLBS
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