Lisata Therapeutics, Inc. · NASDAQ:LSTA
Lisata Therapeutics — Caladrius Biosciences — Investor Presentation (April 2019)
32 slides from Lisata Therapeutics's investor presentation, Apr 11, 2019
Slide 1: Corporate Presentation
Corporate Presentation David J. Mazzo, PhD President and Chief Executive Officer April 2019 | NASDAQ: CLBS
Slide 2: Forward-looking statements advisory
Forward-looking statements advisory 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 certai
Slide 3: Caladrius Biosciences: Uniquely positioned for near-term success
Caladrius Biosciences: Uniquely positioned for near-term success .Late-stage therapeutics development company . Three principal development programs; 2 designated “breakthrough”* . CLBS12*, CLBS14-CMD, CLBS14-NORDA* .Financially stable and debt-free . Strong balance sheet (~$43 million cash as of De
Slide 4: Experienced executive team with broad domain-specific expertise
Experienced executive team with broad domain-specific expertise 35+ years of experience in all aspects of large pharma (Merck, Baxter, RPR, HMR, David J. Mazzo, PhD Schering-Plough) and emerging biopharma (Chugai USA, Regado); successful President and Chief Executive Officer international drug devel
Slide 5: Ischemic Repair Autologous CD34+ cells
Ischemic Repair Autologous CD34+ cells 5
Slide 6: CD34+ cells promote angiogenesis of the microvasculature
CD34+ cells promote angiogenesis of the microvasculature Augmented microvasculature Normal microvasculature Compromised microvasculature post-CD34+ cells introduction Capillaries Capillaries Capillaries Artery Artery Artery Vein Vein Vein . >700 subjects studied in randomized double-blind placebo-co
Slide 7: Simple, scalable and economical autologous cell therapy process
Simple, scalable and economical autologous cell therapy process Isolation of Cells returned to Sample collection CD34+ cells same patient Shipment Shipment Maximum of 4 days from donation to injection Day -3: Patient dosed with GCSF to mobilize CD34+ cells from bone marrow to peripheral blood; avoid
Slide 8: CD34+ cell therapy patent estate provides for long-term exclusivity
CD34+ cell therapy patent estate provides for long-term exclusivity Composition of matter protection to 2031+ . 7 U.S. and 23 foreign composition of matter and methods patents granted . Japan, Russia, Canada, and the EU5 countries-France, Germany, Great Britain, Italy, and Spain . 2 U.S. and 3 forei
Slide 9: CLBS12 Critical Limb Ischemia (CLI) (Japan)
CLBS12 Critical Limb Ischemia (CLI) (Japan) 9
Slide 10: CLI represents an expedited commercial opportunity in Japan
CLI represents an expedited commercial opportunity in Japan . Initiation in Japan prompted by early definition of accelerated path to regulatory approval . Estimated >$100M initial commercial opportunity based on significant pharmaco-eco benefits . CLBS12 could be a marketed product in Japan as earl
Slide 11: CLI amputation and mortality rates increase with disease severity
CLI amputation and mortality rates increase with disease severity Retrospective outcomes analysis based upon Rutherford (“R”) classification (n=41,882) 4 Year Amputation Rates 4 Year Mortality Rates 80.0% 70.0% 63.5% 67.3% 70.0% 60.0% 52.2% 60.0% 50.0% 50.0% 37.7% 40.0% 40.0% 35.3% 30.0% 30.0% 18.9%
Slide 12: Single CD34+ cell therapy administration appears to reverse CLI
Single CD34+ cell therapy administration appears to reverse CLI Actual CLI Patient Laser Doppler Imagery Single Center, Open-Label, Dose-Escalation Clinical Trial (n=17) - Japan Rutherford Scale (All patients) 100% 90% 80% 70% 60% 50% Before Treatment 40% 30% Incidence 20% 10% 0% pre 4 8 12 24 52 10
Slide 13: Single CD34+ cell therapy administration increases amputation free survival
Single CD34+ cell therapy administration increases amputation free survival Double-blind, Randomized, Placebo-controlled Clinical Trial (n=28) 1×10^6 cells/kg Combined Doses 1×10^5 cells/kg Placebo Source: Losordo et al, Circulation 2012 13
Slide 14: CLBS12 eligible for early conditional approval in Japan
CLBS12 eligible for early conditional approval in Japan based on ongoing study Awarded SAKIGAKE (“breakthrough”) designation with priority review Design . Prospective, open label, controlled, randomized trial (1:1 w/SOC) CLI patients Primary Endpoint . Time to continuous CLI-free status (2 consecuti
Slide 15: Preliminary Buerger's Disease cohort results in Japan
Preliminary Buerger’s Disease cohort results in Japan are compelling . Natural progression of Buerger’s Disease is continual progression . CLBS12 treatment has resulted in 50% of patients achieving a positive outcome to date Days Pre 1 30 60 90 120 150 180 210 240 270 300 330 365 1 2 3 Patient 4 5 6
Slide 16: CLBS14-CMD Coronary Microvascular Dysfunction (CMD) (USA)
CLBS14-CMD Coronary Microvascular Dysfunction (CMD) (USA) 16
Slide 17: CMD is an unmet medical need with significant market potential
CMD is an unmet medical need with significant market potential . Nearly 50% of patients with Coronary Artery Disease have a CMD component . Multi-billion dollar global opportunity based on significant pharmaco-eco benefits Patients Potentially Eligible for CLBS14-CMD USA1 Europe2 Japan3,4 ~8,300,000
Slide 18: CLBS14-CMD proof-of-concept study (ESCaPE-CMD)
CLBS14-CMD proof-of-concept study (ESCaPE-CMD) Enrollment completion expected in May 2019 Design . Interventional, open label, proof-of-concept trial Primary Endpoint . Safety and the evaluation of adverse events . Changes from baseline to 6 months for coronary flow reserve, endothelial-dependent Se
Slide 19: Preliminary ESCaPE-CMD results are encouraging
Preliminary ESCaPE-CMD results are encouraging 3.50 . p=0.01675 N=6 (of target 20) 3.00 . Coronary flow reserve is defined as the ratio of maximal coronary 2.50 blood flow to resting coronary blood flow1 2.00 . Increase in coronary flow 1.50 reserve correlates with improvement in symptoms 1.00 . Com
Slide 20: CLBS14-NORDA No Option Refractory Disabling Angina (NORDA) (USA)
CLBS14-NORDA No Option Refractory Disabling Angina (NORDA) (USA) 20
Slide 21: NORDA presents a multi-billion dollar global market opportunity
NORDA presents a multi-billion dollar global market opportunity . Currently, there are no effective treatments options for NORDA . Patients with NORDA often have multiple costly comorbidities Patients Eligible for CLBS14-NORDA USA Europe Japan <100K ~50K ~30K Europe: Source: Independent Third-party
Slide 22: CLBS14-NORDA Phase development status
CLBS14-NORDA Phase 3 development status . Data license obtained from Shire for previous clinical studies . Avoids need to repeat previous work and positions program in Phase 3 . CLBS owns IP for product . CLBS holds an open and active IND . RMAT (Regen. Medicine Advanced Therapy) designation awarded
Slide 23: Single administration of CLBS14-NORDA improves exercise time
Single administration of CLBS14-NORDA improves exercise time Compelling results from the randomized, placebo-controlled, double blind Phase 2 Study (n=168) 6 Months 12 Months P=0.017 P=0.014 Source: Losordo, D.W., et al., Circ Res, 2011 23
Slide 24: Single administration of CLBS14-NORDA reduces angina frequency
Single administration of CLBS14-NORDA reduces angina frequency Compelling results from the randomized, double blind, placebo-controlled, Phase 2 Study (n=168) 6 months 12 months -8.8 -8.7 Frequency, Frequency, (95% CI) -13.9 Mean Change from baseline in Weekly baselineMean Change in from -15.3 p = 0
Slide 25: Single administration of CLBS14-NORDA reduces mortality
Single administration of CLBS14-NORDA reduces mortality Compelling results of the randomized, double blind, placebo-controlled, Phase 2 Study (n=168) p = 0.0065 Placebo Source: Losordo, Circ Res 2011 25
Slide 26: Combined CLBS14-NORDA clinical database corroborates success potential
Combined CLBS14-NORDA clinical database corroborates success potential Change in Angina Frequency . Phases 1, 2, & partial 3 studies1,2,3 ITT Population completed (combined n=304) 1.5 . Two independent compelling patient- P=0.03 P=0.01 P=0.01 level pooled-analyses: 1.0 . European Heart Journal, Janu
Slide 27: Combined CLBS14-NORDA clinical database corroborates success potential
Combined CLBS14-NORDA clinical database corroborates success potential . Phases 1, 2, & partial 3 clinical studies1,2,3 completed (combined n=304) . Two independent compelling patient-level pooled-analyses: European Heart Journal, January 2018 (Henry, et al); Cardiovascular Revascularization Medicin
Slide 28: Multi-product pipeline based on proprietary technology platforms
Multi-product pipeline based on proprietary technology platforms Pre-Clinical Phase 1 Phase 2 Phase 3 CD34+ Cell Therapy Platform Registration eligible trial (Ischemic Repair) CLBS12 Critical Limb Ischemia Country: Japan CLBS14-CMD Coronary Microvascular Dysfunction Country: USA CLBS14CLBS14-NORDA-N
Slide 29: Timeline of key development milestones by project
Timeline of key development milestones by project Program 2019 2020 RMAT application Target Enrollment Phase 2 (registration) response (US) Completion Topline Data Expected CLBS12 ------------------------------------------------------------------------------------------------------------------------
Slide 30: Key CLBS financial information
Key CLBS financial information Cash & Investments at December 31, 2018 $43m 2018 Operating Cash Burn $20m Cash Runway Based on Current Plan through May 2020 (Including CLBS14-NORDA Clinical Initiation Costs) Debt $0 Common Shares Outstanding at December 31, 2018 ~9.9m shares Options Outstanding: Exe
Slide 31: Caladrius Biosciences: Uniquely positioned for near-term success
Caladrius Biosciences: Uniquely positioned for near-term success .Late-stage therapeutics development company . Three principal development programs; 2 designated “breakthrough”* . CLBS12*, CLBS14-CMD, CLBS14-NORDA* .Financially stable and debt-free . Strong balance sheet (~$43 million cash as of De
Slide 32: Investor Relations Contact
NASDAQ: CLBS Investor Relations Contact John D. Menditto Phone: 908.842.0084 Email: jmenditto@caladrius.com www.caladrius.com
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