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Vivo Biosciences Inc. Accelerating Preclinical Research, Drug Discovery & Therapeutics. VBI. Company: Founded in 2004 (DE C-Corp) R&D: $4.2 M via NIH & NASA SBIRs Patents/IP: HuBiogel ™ , MorphoScan ™ Seed Investors: $2 M Toucan Capital & Greer Capital. www.vivobiotech.com
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Vivo Biosciences Inc. Accelerating Preclinical Research, Drug Discovery & Therapeutics VBI Company: Founded in 2004 (DE C-Corp) R&D: $4.2 M via NIH & NASA SBIRs Patents/IP: HuBiogel™, 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@vivobiotech.com
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 R&D consultant, Boston, MA Mina Bissell, PhD Dist. Scientist, Cancer Biology, LBNL, CA VBI Management Team 2
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@vivobiotech.com 3
VBI 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
VBI 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
VBI Important R&D 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
VBI 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
VBI Oncology Drug Screening Services Mini-Tumors of NCI-60 cells and Patient-derived samples In Vivo Tumors: HuBiogel Models: Tumor Growth Tumor Angiogenesis Tumor Invasion Tumor Metastasis • Rapid screening of drugs targeting key tumorigenesis stages • In vivo-like biological & genomic data points 8 Supported by NCI-SBIR program
VBI HuBiogel™ Competitive Advantages Vivo Biosciences B-D, Life Tech, Trevigen Unlike competitors, HuBiogel assay technology offers more physiological relevance and predictability 9
VBI Vivo Biosciences Milestones Milestone R&D Objective Exclusive License/ Worldwide patents HuBiogel-IP Protection Joint R&D 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
VBI High-Value Utility in DD Pipeline A. Current DD Pipeline Primary Screening Cell-based Assays Exploratory Animal Studies IND-Enabling Studies Clinical Trials VBI Advanced DD Pipeline In vivo-Like Human data points Secondary Screening3D 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
VBI 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
VBI Expanded Business Plans Immediate Goals Required Funding Validate 3D HuBiogel Predictability in Animal Models $0.75 M Patient-Chemotherapy Profiling Personalized Medicine: Multicenter study $2.75 M 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, J&J, GSK, Novartis 13
VBI 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
VBI 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