Lisata Therapeutics, Inc. · NASDAQ:LSTA
Lisata Therapeutics — Caladrius Biosciences — Investor Presentation (November 2016)
26 slides from Lisata Therapeutics's investor presentation, Nov 7, 2016
Slide 1: Corporate Presentation
CORPORATE PRESENTATION David J. Mazzo, PhD Chief Executive Officer November 2016 | NASDAQ: CLBS
Slide 2: Forward-looking statements advisory
Forward-looking statements advisory 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 a
Slide 3: Shareholder Value
Shareholder Value The Caladrius business model provides: Complementary independent paths to value creation • Growing fundamental PCT business, a leading cell therapy development and manufacturing partner (CDMO) - Strategic global collaboration with Hitachi - Growing revenues (avg. 24%/year growth si
Slide 4: Caladrius transforms cells into therapies
For our own development candidates and those of our clients, Caladrius transforms cells into therapies From Concept to Commercial Product 4
Slide 5: Cell & Cell-Based Gene Therapy CDMO Excellence in Action
CELL & CELL-BASED GENE THERAPY CDMO Excellence in Action 5
Slide 6: PCT: comprehensive development and manufacturing partner for over 17 years
PCT has been: A comprehensive development and manufacturing partner for over 17 years • Expertise in multiple cell therapy types and therapeutic applications, including: - CAR-T, TCR, T-cell, NK cell, dendritic cells and CD34+ products, among others 6 cGMP Infrastructure Manufacturing Development cG
Slide 7: PCT's extensive client list of renowned cell therapy companies
PCT’s deep experience is evidenced by: An extensive client list of renown cell therapy companies • Historically: >100 clients, 20,000 products and 6,000 patients • Critical contribution from PCT to development and/or clinical manufacturing • Several clients expected to be among next wave to reach co
Slide 8: Growing and maturing cell and cell-based gene therapy market
467 Phase 2 1. Informa/Alliance for Regenerative Medicine. Regenerative medicine clinical trials are as of December 31, 2014 and September 30, 2016. 2. Based on company projections. FDA approvals based on pivotal cell therapy trials and historical rates of P3 success and approval. • Expanding indust
Slide 9: PCT's modern cGMP manufacturing facilities
PCT’s modern cGMP manufacturing facilities offer flexibility and mitigate risk • Allendale, NJ (30,000 ft2) - owned - 3 US-compliant cleanrooms - 5 EU and US-compliant cleanrooms (expansion completion in 1H 2017) - Commercial product infrastructure • Mountain View, CA (25,000 ft2) - leased - 7 US-co
Slide 10: A strategic solution beyond fee-for-service
PCT delivers: A strategic solution that moves well beyond fee-for-service 10 Clinical Manufacturing Process Development Commercial Manufacturing Strategic Manufacturing Assessment Cell therapy product concept Client may enter at any stage
Slide 11: Hitachi equity stake and collaboration with PCT
Offering seamless inter-region product transfer and consistent technology, quality and business systems Hitachi purchases equity stake in PCT US operation March 2016: 19.9% of PCT purchased for $19.4 million Allendale, NJ Mountain View, CA PCT/Hitachi joint venture Terms and timing to be determined
Slide 12: PCT revenue and Caladrius financial information
$0 $5 $10 $15 $20 $25 $30 $35 PCT revenue in millions $ Select Caladrius financial information • As of September 30, 2016 - Cash: $18.6m - Long-term debt: $5.7m - Common outstanding: 8.1m - Options outstanding: 942k - Warrants outstanding: 362k • September 2016 $25m Equity Financing - Common stock “
Slide 13: Immune Modulation: CLBS03 for type 1 diabetes
IMMUNE MODULATION CLBS03 Autologous ex-vivo expanded polyclonal T regulatory cells for type 1 diabetes 13
Slide 14: CLBS03: a unique cell therapy platform for autoimmune diseases
CLBS03 is based on: A unique and promising cell therapy platform for autoimmune diseases • T cell technology from University of California at San Francisco (Jeffrey Bluestone, et al) • Exclusive rights to an international portfolio of issued and pending patents • Polyclonal T regulatory cell platfor
Slide 15: Treg therapy: medical and commercial opportunity for T1D
T Regulatory Cell (Tregs) therapy offers: An attractive medical and commercial opportunity for T1D • Each year >18,000 newly diagnosed patients under 20 years of age in US1; 3% CAGR worldwide2 • No curative treatments, only lifelong insulin therapy (often with serious co-morbidities) • Deficiency in
Slide 16: Scalable and commercially viable manufacturing process
Simple, cost-effective, proprietary Manufacturing process is scalable and commercially viable • Simple and efficient clinical manufacturing process: - Less intrusive cell collection process than other approaches (whole blood vs. apheresis or bone marrow aspiration) - cGMP process developed by PCT im
Slide 17: Published Phase I studies of Treg cell therapy
US Study1 EU Study2 Dose 4-dose escalation cohorts (0.05 x 108 to 26 x 108 cells) 1 dose (10 or 20 million cells/kg) or 2 doses (30 million cells/kg) Patients 14 adult patients with established T1D 22 patients aged 5-18 with T1D Results • Demonstrated safety/tolerance • Established manufacturing fea
Slide 18: Phase 2 study design
Rigorous Design • Double-blind, placebo-controlled, randomized (1:1:1) trial • Adolescent patients ages 12 to <18 with recent-onset T1D Standard Endpoints • Preservation of C-peptide level, insulin use, severe hypoglycemic episodes, glucose and hemoglobin A1c levels Study Size • 111 patients enrolle
Slide 19: Potential application across multiple diseases
Polyclonal T regulatory cell therapy has: Potential application across multiple autoimmune, alloimmune and allergic diseases 19 Multibillion-dollar lifecycle opportunity over these and other indications Steroid-resistant asthma Multiple sclerosis (MS) Chronic obstructive pulmonary disease (COPD) Inf
Slide 20: Additional partnering opportunities: Ischemic repair & Immuno-oncology
ADDITONAL PARTNERING OPPORTUNITIES Ischemic repair & Immuno-oncology 20
Slide 21: CD34 cell technology for ischemic repair
CD34 cell technology for ischemic repair with: Opportunity for route to conditional approval in Japan • CD34 cells shown to induce the development of new blood vessels, preventing tissue death by improving blood flow • Encouraging Phase 2 data applicable to multiple indications • Out-licensed for ch
Slide 22: Tumor cell/dendritic cell technology for immuno-oncology
Tumor cell/dendritic cell technology for immuno-oncology • Uniquely targets cancer-initiating cells • Phase 2 data applicable to multiple indications • Promising Phase 2 melanoma therapeutic effect results with no major safety issues • CLBS technology may open entirely new paths to multiple-antigen
Slide 23: Experienced executive team
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 and Chief Te
Slide 24: Track record of achievement in 2016
Goal Progress in 2016 Grow and expand the PCT business on all fronts • On track to 30% annual revenue growth and annual revenue >$30 million ($15.8m revenue in 1H 2016) • Initiated global collaboration and license agreement with Hitachi Chemical • Began 5-year agreement with Adaptimmune for late-sta
Slide 25: PCT 2016 operating results vs. guidance and upcoming milestones
PCT • 2016 Operating Results vs. Guidance (projected >30% revenue growth to >$30m) End of 2016 Mid-2017 • PCT Allendale, NJ expansion completion: 60% capacity increase with US and EU qualified clean rooms • Conversion of at least one clinical client to commercial contract: Possible major additional
Slide 26: Investor Relations Contact
NASDAQ: CLBS Investor Relations Contact LHA Investor Relations Anne Marie Fields, Senior Vice President Phone: 212.838.3777 Email: afields@lhai.com Web: www.caladrius.com 26
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