Disease Models

Transcription

Disease Models

Changing the Shape of
Medical Research
and Practice
Keith Murphy
Chief Executive Officer
© Copyright 2014, Organovo Holdings, Inc. This report is solely for the use of intended audience. No part
of it may be circulated, quoted, or reproduced for distribution outside the organization without prior
written approval from Organovo Holdings, Inc.
0
FORWARD LOOKING STATEMENTS
The Company cautions you that the statements included in this presentation that are not a
description of historical facts are forward-looking statements. Any forward-looking
statements are based on our current expectations, but are subject to a number of risks
and uncertainties. The factors that could cause our actual future results to differ materially
from our current expectations include, but are not limited to, risks and uncertainties
relating to the Company's ability to develop, market and sell products based on its
technology; the expected benefits and efficacy of the Company's products and technology;
the availability of substantial additional funding to support the Company’s operations; the
Company’s ability to enter into successful collaboration arrangements; the validity of the
Company’s intellectual property rights and the ability to protect those rights; and the
Company's ability to achieve its business, research, product development, regulatory
approval, marketing and distribution plans and strategies. These and other factors are
identified and described in more detail in our filings with the SEC, including our transition
report on Form 10-KT filed with the SEC on May 24, 2013. You should not place undue
reliance on forward-looking statements, which speak only as of the date of this
presentation. Except as required by applicable law, we do not intend to update any of the
forward-looking statements to conform these statements to reflect actual results, later
events or circumstances or to reflect the occurrence of unanticipated events.
NYSE MKT: ONVO
© Copyright 2014 Organovo Holdings, Inc.
1
Organovo NovoGen MMX Bioprinting Platform
© Copyright 2014 Organovo Holdings, Inc. 2
Organovo’s pioneering technology creates
functional human tissues without scaffolds
Tissue sheets, branched tubes, and layered
tubes have been bioprinted
A
B
C
(A) Bio-ink composed of chick cardiac cell aggregates; (B) Bio-ink composed of CHO
cells; (C) A bi-layered tube composed of fibroblasts and smooth muscle cells (brown =
smooth muscle actin). Adapted from Biofabrication 2:1, 2010, coauthored by
K. Murphy and G. Forgacs, ONVO’s CEO and Scientific Founder.
© Copyright 2014 Organovo Holdings, Inc. 4
Drug discovery: There is an imperative for
pharmacos to kill drugs faster and cheaper
5
Substantial Opportunity in Drug
Discovery and Development
 Cell Assay Services and Products
 Bioprinted tissues for customer use
 Disease Models
 Partner in drug discovery
 Receive back end royalty on new drugs
6
Opportunity in Multiple Channels for
Tissues
 Contract Research Model
 High dollar contract services for customer ease
of use
 Established $35B CRO market, $7B Pre-clinical
 $1.75B in vitro preclinical
 $5.25B animal preclinical
 “Human preclinical testing”
7
Overview of Cell Assay Product Model
 Sell bioprinted tissues for customer use
 Overall cell biology market growing to $17B by 2016,
12% CAGR†
 Identified specific market opportunity >$500M by 2018†
 Market growing with CAGR at ~100% 2012-2018
 High unmet customer need and market opportunity
identified that can be met with 3D cell assay products†
† Source:
2012 Scientia Advisors market research,
sponsored by company
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Additional Opportunity with Expansion
of Tissue Portfolio
 Skin for cosmetic toxicology testing
 Higher toxicology testing revenue than pharma
 Total global in vitro tox market 2017 $3.1B 17% CAGR
 Cosmetic testing 46% share of market
 Established research collaboration with
market leader
 Additional resources going to R&D and
Commercial activities
9
Overview of Partner Model
- Disease Models and Therapeutics
 Partner with pharma companies directly
 Build assets over time: Liver, cancer, lung, kidney
 Leverage assets into pharma discovery deals
 3-7% royalty possible
 $10-30M milestone payouts possible per opportunity
10
Opportunity Matrix
Tissue
Research
Program
Toxicology
Assays
(Product/Service)
Disease Models
(Partnerships)
Liver
✔
✔
✔
Lung
Kidney
✔
Simple Tissues
for Therapy
(Clinical)
✔
✔
Cancer
✔
Bone
✔
✔
Blood Vessel
✔
✔
✔
✔
Heart
✔
Skin
✔
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Opportunity Matrix
Tissue
Research
Program
Liver
Toxicology
Assays
Disease Models
(Product/Service) (Partnerships)
✔
Kidney
✔
✔
Lung
✔
Simple Tissues
for Therapy
(Clinical)
✔
✔
Cancer
✔
Bone
✔
✔
Blood Vessel
✔
✔
✔
✔
Heart
✔
Skin
✔
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The NovoGen Bioprinter builds 3D liver tissue
with precise deposition of multiple cell types
100 μm
Hepatic stellate cells (CFSE)
Hepatocytes (DAPI)
Endothelial cells (CTMB)
2.5x (light microscope image)
Three cell types, with cells in relevant architecture
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3D liver tissues with relevant architectural features
were fabricated successfully with the NovoGen Bioprinter
100 μm
100 μm
H&E (200x)
E-Cadherin (200x)
3D Liver is characterized by a tissue-like cell density and tight intercellular
junctions.
14
Bioprinted 3D human liver tissues
are metabolically active with CYP450 induction
Single Unit / 39 h
Single Unit / 135 h
These liver tissues remained stable for
135 hours and retained key liver
functions, including inducible CYP1A2
and CYP3A4 activity.
Constructed w/ 1° hepatocytes, hepatic stellate cells, and endothelial cells
135 h.
15
Bioprinted 3D human liver tissues
synthesize cholesterol and produce albumin
3DA
Bioprinted liver tissues possess the ability
to synthesize cholesterol, a hallmark
liver-associated
function.
Cholesterol
biosynthesis is retained and even
increases over time in culture.
3DB
2D
Bioprinted liver constructs, from iPS
cells produce significantly more
albumin per cell than matched 2D
controls at 135 h.
iPS from Cellular Dynamics, Inc.
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3D Liver in Detail – Business Models
 Toxicology
 Product and service revenue
 3D Liver well-based tissue
 Living cell-based assay
 Disease models
 Partner model
 Hepatitis C / infectivity
 Liver fibrosis
Standard Corning TranswellTM Plates
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3D Liver in Detail – Timelines for Tox Product
 Scientific proof of concept
 April 2013 ✔
 Functional Validation
 Testing against known drugs
 December 2013 ✔
 Delivery to KOLs
 Alpha and beta testing
 April 2014 ✔ (announced Jan ‘14)
 Product launch
 December 2014
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Opportunity Matrix
Tissue
Research
Program
Liver
Toxicology
Assays
Disease Models
(Product/Service) (Partnerships)
✔
Kidney
✔
✔
Lung
✔
Simple Tissues
for Therapy
(Clinical)
✔
✔
Cancer
✔
Bone
✔
✔
Blood Vessel
✔
✔
✔
✔
Heart
✔
Skin
✔
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Partnering to Develop Cancer and Other Assets
 OHSU Partnership
 Cancer research top investigators (Gleevec, FISH)
 Allows Organovo to move upstream in discovery efforts
 Scientific publications could appear within 8-18 months
 NIH Partnerships with NEI and NCATS
 National Eye Institute – building eye tissue
 National Center for Advancement of Translational Sciences – Drug Discovery
NCATS Mission: enhance development and testing of therapeutics
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Bioprinted Breast Cancer Tumor Models
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Organovo Has Long Term Opportunity in Tissue
Therapy
Simple and branched tubular structures
Tissue opportunities
 Direct surgical therapy for patients
 Simple tissues that can be bioprinted
today
Bioprinted
Branched Vessel
 Focus on commercial outcome
 Regulatory pathway
 Market size and reimbursement
outlook
Tissue patches

22
Organovo Targeted Milestones and Potential
Results – Next 24-36 months
 Development and launch of 3D Liver
 Scientific proof of concept - April 2013 ✔
 Functional Validation - December 2013 ✔
 Delivery to KOLs - Alpha and beta testing ✔ (Announced January 2014, original target April)
 Product launch - December 2014 (Announced pre-release commercial contracts starting in April)
 Breast cancer model initial data December 2013 ✔
 Detail on additional tissue product/service launches
 Multiple additional pharma partnerships
 Scientific updates on disease models – Kidney, Liver
 Therapeutic tissue proof of concept and path to clinical
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Executive Management
KEITH MURPHY, CEO & President





20 years of experience in biotechnology
Amgen, 10 years, Global Operations Leader, Prolia/Xgeva
Alkermes, drug delivery technology background
UCLA, School of Business
MIT, Chemical Engineering
BARRY MICHAELS, CFO & Secretary



30 years of financial and general management experience in medical device and
biotechnology
CFO of three private and three publicly traded companies
Finalist, San Diego CFO of the Year for 2012
SHARON PRESNELL, Ph.D., CHIEF TECHNOLOGY OFFICER & EVP, R&D




15 years of leadership experience in product-focused R&D
SVP of R&D Tengion, Inc.
6 years R&D Leadership at Becton Dickinson
Asst. Professor, U. of North Carolina, Chapel Hill
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Executive Management
ERIC MICHAEL DAVID, M.D., J.D., CHIEF STRATEGY OFFICER




17 years of experience in biopharma
Associate Partner, McKinsey & Company
Life Science Pipeline and R&D Strategy Consulting
Adjunct Faculty, Rockefeller University
MIKE RENARD, EXEC VP COMMERCIAL OPS



Proven revenue generating product wins in research and diagnostics
instrumentation and consumables
25+ years in life sciences
Experience building and launching products at Beckman Coulter and Sanofi
25
Board of Directors
KEITH MURPHY
(Chairman)
 Organovo Chief Executive Officer
TAMAR HOWSON
 Director: Warner Chilcott, Idenix
Former roles:
JAMES GLOVER (Audit Chair)
Former roles:
 CFO, Beckman Coulter
 CFO, Anadys Pharmaceuticals
 Director and Audit Chair, Varian
 (acquired by Agilent, $1.5B)
ROBERT BALTERA
Former roles:
 CEO, Amira Pharmaceuticals
(acquired by BMS, up to $475M)
 VP Finance, Amgen
 SVP of Corporate Development,
Bristol-Meyers Squibb
 SVP of Corporate Development,
SmithKline Beecham
 Head of SROne (GSK Venture arm)
RICHARD HEYMAN
Former roles:
 CEO, Aragon Pharmaceuticals
(J&J acquired for up to $1B)
 CSO, Kalypsis, Inc.
 VP Research, Ligand Pharma
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Organovo’s Bioprinting Technology:
 Accelerates breakthrough research
 Better recreation of “human biology in a petri dish”
 Better than animal models
 Better than cells alone
 Has broad applications for unmet needs
 Pharma Drug Discovery (Near term)
 Toxicology Testing (Near term)
 Transplant tissues (Longer term)
27
Enabling tissue on demand
NYSE MKT: ONVO
Organovo Contacts:
Investor Relations
Booke and Company
[email protected]
(646) 571-2439
Website
http://www.organovo.com
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Disease Models

Transcription

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