Lisata Therapeutics, Inc. · NASDAQ:LSTA
Lisata Therapeutics — Caladrius Biosciences — Investor Presentation (March 2016)
27 slides from Lisata Therapeutics's investor presentation, Mar 17, 2016
Slide 1: Caladrius Biosciences Corporate Presentation
Caladrius Biosciences Corporate Presentation David J. Mazzo, PhD, Chief Executive Officer March 2016 NASDAQ: CLBS 1
Slide 2: Forward-looking statements
2 Forward-looking statements This 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 and unce
Slide 3: Company Overview and Investment Opportunity
3 Company Overview • Caladrius, through its subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry - 2015 Revenues: $22.5 Million (averaging 25% annual growth over past three years) - Headquarters in Basking Ridge, NJ with locations in Allendale, NJ, New Yor
Slide 4: Transforming cells into therapies: From Concept to Commercial Product
Transforming cells into therapies From Concept to Commercial Product 4
Slide 5: PCT: Premier cell therapy development and manufacturing partner
PCT is a subsidiary of Caladrius Biosciences and is its Center of Excellence for process development, engineering and manufacturing cGMP Infrastructure Innovation cGMP Manufacturing Technology Transfer GTP Processing Logistics Process Optimization and Automation Consulting Analytical Development Man
Slide 6: Unmatched experience: >100 clients, 20,000 products, 6,000 patients
Unmatched experience: >100 clients, 20,000 products and 6,000 patients over 17 years validate the benefits of PCT Selected Clients: 6 Clients with late phase clinical programs expected to be among the first to potential commercialization 6
Slide 7: PCT is a premier cell therapy service provider
7 PCT is a premier cell therapy service provider • Specializes only in cell and cell-based gene therapy development and manufacturing • Proven efficiency enhancement and reduced capital investment for clients vs. internal commitment - From preclinical to commercial • Demonstrated regulatory expertis
Slide 8: Expertise in multiple cell types and therapeutic applications
Expertise in multiple cell types and therapeutic applications • Immunotherapy - T cells / CAR-T cell therapy - Tumor cells - Dendritic cells - Natural killer cells - B cells - Macrophages - Donor lymphocyte infusion • Neuro/endocrine - Neural stem cells - Porcine islets • Hematopoietic replacement -
Slide 9: Delivering a strategic solution through flexible capacity
9 Delivering a strategic solution through flexible capacity • Supplants expensive, time-consuming facility build-outs • Mitigates challenges in forecasting capacity use • Provides client-specific scalable manufacturing solutions • Anticipates and provides solutions for evolving regulatory needs • In
Slide 10: PCT offers a complete development pathway
10 PCT offers a complete development pathway Clinical Manufacturing Process/ Manufacturing Development Commercial Manufacturing Strategic Manufacturing Assessment Cell therapy product concept Client may enter at any stage
Slide 11: Strategic global collaboration with Hitachi Chemical Co.
11 Strategic global collaboration with Hitachi Chemical Co. Creating a global commercial enterprise with deep engineering expertise Allendale, NJ Mountain View, CA Hitachi purchases 19.9% equity stake in PCT US operation Intention to pursue PCT/Hitachi joint venture Hitachi licenses PCT technology a
Slide 12: Caladrius base business model
Caladrius base business model 12 Cell Therapy Developers & Academia Expertise Revenue Value Creation PCT: a growing business providing development, manufacturing and delivery of cell-based therapies
Slide 13: Caladrius enhanced business model
Caladrius enhanced business model 13 Cell Therapy Developers & Academia Expertise Revenue Value Creation Partnering post- POC provides value inflection and an additional stream of new PCT clients
Slide 14: CLBS03: Type 1 Diabetes Mellitus (T1D)
14 • T Cell technology • Phase 2 proof-of-concept stage • PCT-developed manufacturing process • Strategic collaboration with Sanford Research Immune Modulation CLBS03: Type 1 Diabetes Mellitus (T1D)
Slide 15: T Regulatory Cells: restoring immune balance and function
15 T Regulatory Cells (Tregs): restoring immune balance and function Normal immune system: immune balance Infusion of Tregs: balance regained Autoimmunity: immune imbalance T regulatory cells T effector cells Natural polyclonal T regulatory cells Simple, cost-effective process with protected intelle
Slide 16: Type 1 Diabetes: Unmet needs create an attractive opportunity
16 Type 1 Diabetes: Unmet needs create an attractive medical and commercial opportunity Beta Cells T Effector Cell-Mediated Killing of Beta Cells T Effector Cell T Regulatory Cell T Regulatory Cell Defense of Beta Cells 1. Information TNND. National Diabetes Statistics. 2011 2. Maahs DM, et al. Endo
Slide 17: Treg cell therapy appears well tolerated and durable
17 Treg cell therapy appears well tolerated and durable1 1. Gitelman et al, American Diabetes Association Abstract, 2014. 2. Dr. Jeffrey Bluestone Lab Study Leadership Jeffrey Bluestone, PhD of UCSF, leader in field of Tregs Design US UCSF/Yale open-label Phase 1 study, 4-dose escalation cohorts Pat
Slide 18: Treg cell therapy preserves beta cell function in children
Treg cell therapy preserves beta cell function in children1 Marek-Trzonkowska, N t al. Clinical Immunology 2014 1. Children aged 5-18 administered 1 (10 or 20 mil cells/kg) or 2 doses (total 30 mil cells/kg) of Tregs 0 0.2 0.4 0.6 0.8 1 1.2 Day O Month 4 One Year Fasting C-peptide levels stabilized
Slide 19: T-Rex Study: Phase 2 proof-of-concept in adolescents with T1D
T-Rex Study: Phase 2 proof-of-concept in adolescents with T1D1 Design • Double-blind, placebo-controlled, randomized (1:1:1) trial • Adolescent patients ages 12 to 17 with recent-onset T1D Key Endpoints • Preservation of C-peptide level, insulin use, hypoglycemic episodes, hemoglobin A1c level (all
Slide 20: T-Rex Study: Efficient asset de-risking study design
20 2016 Part 1 N = 18 Start-up 1st patient randomized March 7, 2016 Sanford sites activated 3-Month Follow Up* Year 2 2016 Part 2 N = 93 Additional sites activated Enrollment & Treatment 19th patient randomized* 2017 Regulatory/Strategic go/no-go T-Rex Study: Efficient asset de-risking study design
Slide 21: Potential application across multiple autoimmune and allergic diseases
Potential application across multiple autoimmune and allergic diseases 21 Multibillion-dollar lifecycle opportunity Steroid-resistant asthma Multiple sclerosis (MS) Chronic obstructive pulmonary disease (COPD) Inflammatory bowel disease Graft vs. Host disease Rheumatoid arthritis Lupus
Slide 22: Additional Technology Platforms for Partnering
22 • Phase 2 data for both platforms • Applicability to multiple indications Additional Technology Platforms for Partnering • CD34 cell technology for ischemic repair • Tumor cell/dendritic cell technology for immuno-oncology
Slide 23: CD34 cell technology for ischemic repair
23 CD34 cell technology for ischemic repair • CD34 cells shown to induce the development of new blood vessels, preventing tissue death by improving blood flow • Significant unmet need for critical limb ischemia (CLI) and chronic heart failure (CHF) • Partnering discussions advancing for Japanese dev
Slide 24: Tumor cell/dendritic cell technology for immuno-oncology
24 Tumor cell/dendritic cell technology for immuno-oncology • Uniquely targets cancer-initiating cells, applicability to multiple indications • Checkpoint inhibitors reduce impediments to an existing path - CLBS technology may open entirely new paths to multiple-antigen recognition • Promising Phase
Slide 25: Experienced executive team with broad domain-specific expertise
Experienced executive team with broad domain-specific expertise David J. Mazzo, PhD Chief Executive Officer 30+ years of experience in all aspects of large and emerging global biotech, biopharma company operations, successful international drug development Robert A. Preti, PhD Senior VP, Manuf. and
Slide 26: Select financial information
26 Select financial information As of December 31, 2015 • Cash: $20.3m (1) • Long-term debt: $15m (1) • Common outstanding: 57m • Options outstanding: 7m (avg. $5.56) • Warrants outstanding: 3m (avg. $13.71) (1) On March 11, 2016, $19.4 million in cash received in the Hitachi transaction, and $7.0 m
Slide 27: Investor Relations Contact
Investor Relations Contact: LHA Investor Relations Anne Marie Fields, Senior Vice President Phone: 212.838.3777 Email: afields@lhai.com Web: www.caladrius.com NASDAQ: CLBS 27
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