Lisata Therapeutics, Inc. · NASDAQ:LSTA
Lisata Therapeutics — Caladrius Biosciences — Investor Presentation (April 2019)
31 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 Single Center, Open-Label, Dose-Escalation Clinical Trial (n=17) - Japan Laser Doppler Imagery 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 based on ongoing study
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: CLBS14-NORDA No Option Refractory Disabling Angina (NORDA) (USA)
CLBS14-NORDA No Option Refractory Disabling Angina (NORDA) (USA) 19
Slide 20: 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 21: 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 22: 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 22
Slide 23: 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 24: 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 24
Slide 25: 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 26: 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 27: 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 28: 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 29: 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 30: 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 31: 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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