Vivo Biosciences Inc'

1
Vivo Biosciences Inc. Accelerating
Preclinical Research, Drug Discovery
Therapeutics
VBI
Company Founded in 2004 (DE C-Corp) RD
4.2 M via NIH NASA SBIRs Patents/IP HuBiog
el, MorphoScan Seed Investors 2 M Toucan
Capital Greer Capital
www.vivobiotech.com 1601 12th Avenue South,
Birmingham, AL 35205, USA Ph 205-930-0001, Fax
205-930-0082 Contact_at_vivobiotech.com
2
Management Team

• Board Members
• Raj Singh, PhD Founder, President CEO
• Larry DeLucas, PhD Professor Director, CBSE,
  UAB
• Albert LoBuglio, MD Oncologist Director, CCC,
  UAB
• Linda Powers, JD Managing Director, Toucan
  Capital, MD
• Larry Greer, DDS, MBA Managing Director, Greer
  Capital, AL
• Sr. Business Director
• Lee Martin, PhD Business Development
  Marketing
• Advisors Consultants
• Norton Peet, PhD International RD consultant,
  Boston, MA
• Mina Bissell, PhD Dist. Scientist, Cancer
  Biology, LBNL, CA

2
3
Vivo Biosciences Inc. Accelerating
Preclinical Research, Drug Discovery
Therapeutics
VBI

• New 3-Dimentional or Mini-Tumor Bioassay
  Technology
• Identify Good Drug Candidates
• Make Better Preclinical Decisions
• Predict Therapy Response in Patients

NIH-LARTA 2009 Venture Forum, San Jose, CA
Rsingh_at_vivobiotech.com
3
4
Unmet Need in Therapeutics

• Current Drug Discovery Challenges
• Over 40 drug candidates fail at preclinical
  stage
• (efficacy/toxicity concerns)
• Rising drug development/failure/recall costs
• (1.2 B per Drug)
• Differing Chemotherapy response in patients
• (Patient population diversity)

4
5
Reason for Drug Failure
Look at the Biology models being used
Flat 2D Biology but not Tissue function
(Monolayers on Plastic or Biomatrix)
Cell-Based Assays
Hits or Leads
Physiological but not Human biology (Xenograft
studies)
Animal Models

• Poor predictors of drug response in humans
• US FDA Europe EMEA initiatives to
  reduce/refine animal usage

5
6
Important RD Solutions

• Develop improved biology models
• (Accelerate drug discovery/success)
• Obtain better preclinical data points
• (Reduce animal usage/expenses)
• Better prediction of patient therapy response
  (Personalized Medicine)

Vivo Technology is Timely Promising
6
7
New 3D HuBiogel Assay Platform
NASA-Bioreactors
HuBiogel Proprietary 3D Biomatrix Culture
System
Cell lines
or
Patient Samples
2-3 wks
Host Tissue
Tissue-like Assays

• Allows host cells to grow, organize function
  as mini-tumors
• New all-human 3D bioassay for real-time
  functional analysis

7
R. Singh et. al. Drug Discovery International,
5 16-19, 2007
8
Oncology Drug Screening Services Mini-Tumors of
NCI-60 cells and Patient-derived samples
In Vivo Tumors
Tumor Growth
Tumor Angiogenesis
Tumor Invasion
Tumor Metastasis
HuBiogel Models

• Rapid screening of drugs targeting key
  tumorigenesis stages
• In vivo-like biological genomic data points

8
Supported by NCI-SBIR program
9
HuBiogel Competitive Advantages
Vivo Biosciences
B-D, Life Tech, Trevigen
Unlike competitors, HuBiogel assay technology
offers more physiological relevance and
predictability
9
10
Vivo Biosciences Milestones
Milestone
RD Objective
Exclusive License/ Worldwide patents
HuBiogel-IP Protection
Joint RD projects with CRO companies
GLP-Labs HTP-Facility
Product/kit marketing via distributors
Sales of HuBiogel Reagents
Preclinical contracts w/Pharma
New Mini-Tumor Assay Services
Supported via Seed Investment funding
10
11
High-Value Utility in DD Pipeline
Current DD Pipeline
A.
Exploratory Animal Studies
Primary Screening Cell-based Assays
IND-Enabling Studies
Clinical Trials
VBI Advanced DD Pipeline
In vivo-Like Human data points
Secondary Screening 3D HuBiogel Assay Platform
Better Preclinical Outcome
B.
Cost Benefits
5 K 20 K
2 K 3 K / Test
200 - 300 K
1.3 - 1.5 M

• A Present clinical failure rate due to lack of
  efficacy 28 (1 in 4 drugs)
• B Improved DD Pipeline 25-50 reduction in risk
  with animal IND costs

11
12
Better Go/No-Go Preclinical Decisions
Integration of HuBiogel Assays in Oncology DD
programs advances good drug candidates
In pancreatic cancers
FDA-Critical Pathway Initiative Better biology
models
12
13
Expanded Business Plans
Immediate Goals
Required Funding
Validate 3D HuBiogel Predictability in Animal
Models
0.75 M
2.75 M
Patient-Chemotherapy Profiling Personalized
Medicine Multicenter study
New Human Drug Toxicity Models Hepatotox,
Neurotox, Cardiotox
1.5 M
Vivo Biosciences is Seeking 5.0 M via
Partnership Bio-Venture Investment Deal
Takeda-Millennium, Eli Lilly, Roche-Genentech,
JJ, GSK, Novartis
13
14
Oncology DD Toxicology Markets
Market Size Projected Growth

• Niche Markets
• No CROs offering 3-D bioassays for oncology
  discovery and toxicity
• CROs Covance, Charles River Labs, MDS Pharma,
  MPI Research, Shin Nippon, WIL Research, Toxikon
• Market Capture Strategy
• In-vivo like relevance of 3D HuBiogel Assays
  drives market capture
• Existing Alginate- and Matrigel-based bioassays
  pose many limitations
• Strategic partnerships to gain market exposure
  B2B marketing plans

Revenues Projected Growth
Oncology Discovery
In Vitro Toxicology
Source Wall Street Analyst, NCI and VBI Estimates
15
Personalized Medicine Market
Market Size Projected Growth

• Market Makers
• Majority are offering gene/biomarker profiling of
  but not cellular assays
• Genomics Health, Roche Diagnostics, Abbott Labs,
  Celera Corp., Caliper Life Sci, Gen-Probe,
  Precision Therapeutics, Applied Genomics
• Market Capture Strategy
• Precise tumor sensitivity vs molecular profiling
  enables market share capture
• Accurate predictability in 3D HuBiogel Assays for
  patient drug response
• Strategic expansion of commercial operations
  based on revenue growth

Revenues Projected Growth
Therapy profiling with 150-200 patients
Source Wall Street Analyst, NCI and VBI Estimates