Technical and Business Overview December 9, 2013 By Jim Musick, Ph.D. President & CEO
Dec 06, 2014
Technical and Business Overview
December 9, 2013
By Jim Musick, Ph.D.
President & CEO
Location of Golden, CO Facility
VITRO BIOPHARMA GOLDEN COLORADO, JUNE 2008
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
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
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
GFP-Expressing Human MSCs Catalog Number SC00A4
Fluorescent Image of Single Human MSC
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
Human MSC Growth in MSCGroTM vs Competitors Media:
MSCGroTM results in faster growth & 2-3-fold greater cell recovery
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
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.
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
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
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.
Osteoporosis Drug Discovery: Cell-Based Assay
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
Stem Cell Regenerative Medicine
• Market description• Market Size• Strategy and Status
Wound care products
Muscular skeletal targets: Osteoarthritis, bone regeneration, ligament/tendon repair
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