vitro biopharma-business & technical overview 12 9-13

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Technical and Business Overview December 9, 2013 By Jim Musick, Ph.D. President & CEO

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

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Page 1: Vitro Biopharma-Business & technical overview 12 9-13

Technical and Business Overview

December 9, 2013

By Jim Musick, Ph.D.

President & CEO

Page 2: Vitro Biopharma-Business & technical overview 12 9-13

Location of Golden, CO Facility

Page 3: Vitro Biopharma-Business & technical overview 12 9-13

VITRO BIOPHARMA GOLDEN COLORADO, JUNE 2008

Page 4: Vitro Biopharma-Business & technical overview 12 9-13

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

Page 5: Vitro Biopharma-Business & technical overview 12 9-13

Team Vitro Partners & Collaborators

Neuromics, Inc. Merger candidate/distributorJames Posillico, PhD. FSH Patent LicenseeSean Marconi IR/PR & Social MediaHemoGenix, Inc. LUMENESC AssayLabs Inc. CRO/Flow cytometry collaborationCCNY Professor Lane Gilcrest: Research CollaborationCelartia, Inc. Distributor

Page 6: Vitro Biopharma-Business & technical overview 12 9-13

STEM CELLPRODUCTS

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

Page 7: Vitro Biopharma-Business & technical overview 12 9-13

GFP-Expressing Human MSCs Catalog Number SC00A4

Fluorescent Image of Single Human MSC

Page 8: Vitro Biopharma-Business & technical overview 12 9-13

MSCGroTM at Day 3 MSCGroTM at Day 4

Lonza at Day 3 Lonza at Day 4

MSC Growth in Low Serum MSCGro™Compared to Lonza MSC-GM

Page 9: Vitro Biopharma-Business & technical overview 12 9-13

Human MSC Growth in MSCGroTM vs Competitors Media:

MSCGroTM results in faster growth & 2-3-fold greater cell recovery

Page 10: Vitro Biopharma-Business & technical overview 12 9-13

0 1 2 3 4 5 6 7 8 9 10 11 12 13 140

20

40

60

80

100

120

140

160

Dou

blin

g Ti

me

(Hrs

)

Months at 2-8oC

MSCGro at 5% O2

MSCM-ScienCell at 5% O2

MSCGro at 20% O2

(Adipose MSCs by third party)

Real Time Stability of MSCGroCompared to Competitor's Medium

Page 11: Vitro Biopharma-Business & technical overview 12 9-13

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.

Page 12: Vitro Biopharma-Business & technical overview 12 9-13

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

Page 13: Vitro Biopharma-Business & technical overview 12 9-13

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

Page 14: Vitro Biopharma-Business & technical overview 12 9-13

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.

Page 15: Vitro Biopharma-Business & technical overview 12 9-13

Osteoporosis Drug Discovery: Cell-Based Assay

Page 16: Vitro Biopharma-Business & technical overview 12 9-13

Osteoporosis Drug Pipeline

Sponsor Drug Target Phase

Amgen Romosozumab SOST neutralization

III

Amgen AMG 167 SOSTNeutralization

I

Lilly Blososumab SOSTNeutralization

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

Page 17: Vitro Biopharma-Business & technical overview 12 9-13

Stem Cell Regenerative Medicine

• Market description• Market Size• Strategy and Status

Wound care products

Muscular skeletal targets: Osteoarthritis, bone regeneration, ligament/tendon repair

Page 18: Vitro Biopharma-Business & technical overview 12 9-13

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