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Vitro Biopharma-Business & technical overview 12 9-13

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Overview of Business Strategy and Stem Cell Research and Regenerative Medicine Solutions

Overview of Business Strategy and Stem Cell Research and Regenerative Medicine Solutions

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  • 1. Technical and Business Overview December 9, 2013 By Jim Musick, Ph.D. President & CEO
  • 2. Location of Golden, CO Facility
  • 3. VITRO BIOPHARMA GOLDEN COLORADO, JUNE 2008
  • 4. The Vitro Management Team James R Musick, Ph.D, President, CEO & Chairman of the Board Pete Shuster, Director Duane Knight, CPA, SAB Joe Nieusma, Ph.D., SAB Pamela Rice, Ph.D., SAB
  • 5. Team Vitro Partners & Collaborators Neuromics, Inc. Merger candidate/distributor James Posillico, PhD. FSH Patent Licensee Sean Marconi IR/PR & Social Media HemoGenix, Inc. LUMENESC Assay Labs Inc. CRO/Flow cytometry collaboration CCNY Professor Lane Gilcrest: Research Collaboration Celartia, Inc. Distributor
  • 6. STEM CELL PRODUCTS Focus on Mesenchymal Stem Cells • Numerous Clinical Uses: Joint disease & injury, autoimmunity, stroke, organ failure (heart, liver, kidney & lung), MS, promotion of HSC engraftment, regenerative medicine, cancer, hearing loss, etc. • Readily Available: Blood, adipose (fat) tissue, bone marrow, teeth, etc
  • 7. GFP-Expressing Human MSCs Catalog Number SC00A4 Fluorescent Image of Single Human MSC
  • 8. MSC Growth in Low Serum MSCGro™ Compared to Lonza MSC-GM MSCGroTM at Day 3 Lonza at Day 3 MSCGroTM at Day 4 Lonza at Day 4
  • 9. Human MSC Growth in MSCGroTM vs Competitors Media: MSCGroTM results in faster growth & 2-3-fold greater cell recovery
  • 10. 160 Real Time Stability of MSCGro Compared to Competitor's Medium 140 Doubling Time (Hrs) 120 MSCGro 100 at 5% O2 MSCM-ScienCell at 5% O2 80 MSCGro at 20% O2 (Adipose MSCs by third party) 60 40 20 0 0 1 2 3 4 5 6 7 8 9 o Months at 2-8 C 10 11 12 13 14
  • 11. Competitive Advantages of MSCGroTM • MSC growth rate/cell recovery > Lonza, InVitrogen, Stem Cell Technologies, ScienCell & ZenBio media. • MSC quality/potency (Lumenesc™) > Lonza, InVitrogen and Stem Cell Technologies media. • Vastly improved real time stability. • Medium function unaffected by freezing. • Out-performs competitors at both reduced & ambient O2 • Supports self-renewal of human, rat & mouse MSCs • Also supports primary cultures: fibroblasts (human & rat); rat cardiomyocytes & possibly hepatocytes • Provided complete & ready to use as is.
  • 12. Neuromics, Inc. Research Products Wide range of Research Products (2500 total) • Antibodies & proteins • Stem cell-based products • Primary cells • Cell-based assays • Molecular Biology Products
  • 13. Drug Discovery and Development Overview • Problems with current discovery technology: High failure rate; side-effects • Advantages of stem cell-derived systems: Reduce false positives in animal systems High specificity due to biological targeting Cost-effective, high-throughput, automatic • Market Size & Strategic Plan
  • 14. Need and Market for Osteoporosis Drugs • Osteoporosis is a growing, top-10 global disease • Market ~ $11 billion USD by 2015. • Anti-resorptive drugs block osteocylasts & bone loss • Pathology is age and/or hormone-induced impaired osteogenesis. • New anabolic drugs induce bone growth and decreased fracture risk. • Current anabolic drugs have side effects & must be discontinued after two years use.
  • 15. Osteoporosis Drug Discovery: Cell-Based Assay
  • 16. Osteoporosis Drug Pipeline Sponsor Drug Target Phase Amgen Romosozumab SOST neutralization III Amgen AMG 167 SOST Neutralization I Lilly Blososumab SOST Neutralization II Lilly LY2874455* FGFR Anatagonist II Merck MK-0822 (Odanacatib) Cathepsin K inhibitor III Takada NE-58095 (risedronate) Osteoclast inhibitor III Lexicon Pharmaceuticals LP533401 5-HT Synthesis inhibition I * Approval sought for non-osteoporosis indication
  • 17. Stem Cell Regenerative Medicine • Market description • Market Size • Strategy and Status Wound care products Muscular skeletal targets: Osteoarthritis, bone regeneration, ligament/tendon repair
  • 18. Intellectual Property • Issued & Pending Patents: – – – – FSH Production/generation; Adult stem cell generation, iPSCs without transfection, Regenerative medicine materials & procedures. • Strategy to increase competitive advantages & FTO