bioquark rodman & renshaw presentation 2012
Post on 05-Jul-2015
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FORWARD LOOKING STAEMENTS AND DISCLAIMER OF RISKS AND UNCERTAINTIES
Some of the statements contained and incorporated in this presentation are forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. Such statements are based upon the current beliefs and expectations of Bioquark Inc.’s management as of the time the presentation is made and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. Forward statements can be identified by the fact that they do not relate strictly to historical or current facts. Investors and the public are cautioned not to place undue reliance on these forward-looking statements, which speak only to the date such data was presented. Examples include statements of anticipated needs of patients, our ability to address those needs, and projected future gains for investors. Bioquark Inc. undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the presentation of this information, whether as a result of new information, subsequent events or otherwise. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: increased competition; increased costs; changes in general market conditions; changes in industry trends; changes in the regulatory environment; changes in technology; changes in the Bioquark Inc.’s plans, initiatives and strategies.
About Bioquark Inc.
• Biopharmaceutical company • Lead biologic candidate - BQ-A • Regeneration and repair of organs and tissues • Incorporated in May 2008 • Delaware C-Corp • Central Laboratory – Tampa, FL
Seed money - US $750K
Currently raising:
- US $1MM via Reg D 504 private placement - US $20MM via self-registered public offering to: - pre-clinical development of BQ-A - BQ-A manufacturing scale-up (CMC) - BQ-A clinical data of in FSGS
Major investor value inflection in 3 years
Capitalize on short term opportunities in derma-cosmetic and companion animal health
Bioquark Inc. - Financing
Market Opportunity Global Healthcare - OECD est. 2012 - >$6 Trillion
Cellular Degeneration Alzheimer’s
CHF Parkinson’s
Type I Diabetes etc.
Cellular Damage Auto-immune
Cancer Chronic Inflammation
etc.
Organ Transplantation / Replacement
Organ Annual Deaths from
Failure People Waiting For a Transplant
Annual # of Organ Transplants
Heart 874,000 2,900 2,200
Lung 159,000 2,000 1,500
Kidney 44,000 86,000 17,000
Pancreas 32,000 1,600 500
Liver 28,000 17,000 6,500
Intestine 1,200 300 200
Bladder 15,000 N/A N/A
Total 1,153,200 109,800 27,900
- Worldwide >$350B / yr (inc. dialysis, CRM, stents, anti-rejection drugs) - Host versus graft reaction - Major donor / recipient imbalance
Pharmaceuticals Don’t Reverse Damage
Direct Killing
Transporter Interaction
Substance Replacement
Enzyme Interaction
Receptor Interaction
Stem Cells???
Technical / Strategic Issues
Plasticity Genomic Instability
Stress Induced Apoptosis Senescence
Heteroplasmy Tumorigenicity
Immunogenicity Infection
Tissue homeostasis Engraftment
Paracrine Inhibition Survivability
Positional Identity Size Control
Shape 3D Patterning
- Embryonic - Adult - Fetal - Induced Pluripotent - Cord - Parthenogenic - etc.
Minimal Successful Outcomes
To Date
Epimorphosis
De-differentiation
Proliferation
Re-differentiation
Re-Integration Tissue Organization
Damage
Size / Positional Specification
Morphogenesis
Reprogramming
Oocyte - Biological Re-Start
Epigenetic Modifications Nuclear DNA Repair Morphogenesis
Mitochondrial DNA Repair
Infectious / Oxidative / Inflammatory Defense
Microenvironment Regulation
Telomere Control
Organelle Remodeling
Microenvironment Centric Embryo Blastema
Normal Fetus Normal Limb
Introducing foreign tissues
such as: - Stem Cells
- Somatic Cells - Cancer Cells
Abnormal
BQ-A – Standardized Ooplasm Factors
FDA - Regulated under PHS Act - Polypeptide/carbohydrate based - Extracted from living organism - Complex physiochemical structure - Less well defined than NCE - Mfg process defines product
EMEA - produced by or extracted from a biological source - combination of physico-chemical- biological testing - production process and its control is needed for its characterization and the determination of its quality
BQ-A - Melanoma Tumor Invasiveness Bio-Marker Expression
COX-2 Expression
i-NOS Expression
Non-treated BQ-A (7 days) BQ-A (14 days) BQ-A (21 days) Control
Non-treated BQ-A (7 days) BQ-A (14 days) BQ-A (21 days) Control
BQ-A - TBI Model
Control (No TBI) 14 days after TBI BQ-A treatment 14d
β-amyloid Immuno-histochemistry
Brain Gross Anatomy
BQ-A - TBI Model - Morris Water Navigation Task
Testing hippocampus impaired spatial learning and memory
1st Clinical Target - Kidney - NIDDK - 2007 - >500K Americans suffer from End-Stage Renal Disease (ESRD) - > 111K new cases diagnosed – 90K deaths annually - > $30 billion in care – 370K on dialysis – 17K kidney transplants - FSGS indication offers:
- rapid proof-of-concept - FDA Subpart E - orphan disease classification benefits
BQ-A - FSGS Development Plan
- Repair and regenerate podocytes - Induce clinical remission - as measured by reduction in proteinuria
2012 2013 2014 2015 2016
Partnering Strategy
- Organ Specific Development - Generate later stage clinical data - License to specialty pharma along specific “organ verticals” - Keep eye on tangential opportunistic markets / spin-outs (derma-cosmetic; companion animal health)
BQ-A - Intellectual Property Protection Much more than typical drug
- Patents Composition Use MOA Production Genetic variety - Industrial Scale Biologic Manufacturing Trade Secrets - Heterogeneous Bioequivalence Barrier (i.e. Premarin- style multiple decade exclusivity)
Generic competition highly unlikely
Therapy Global Costs Regeneration Repair
Organ Transplant / Replacement
~$300 Billion - Host vs. Graft Reaction - Insufficient Supplies - Cost
N/A
Pharmaceuticals / Growth Factors
~$600 Billion - Limited to conditions where single growth factor predominates (EPO, GM-CSF, BMP)
- Cannot reverse genetic damage once it has occurred
Stem Cells / Cell Therapy
~$4 Billion - Technical problems - Regulatory - Cost
- Effects limited to trophic support - Cost
BQ-A N/A - Provides dual solution in reprogramming tissues for both tissue regeneration and repair - Administered via traditional biopharma delivery vehicles - Regulated as biologic by both FDA and EMEA - Cost effective
BQ-A - Strategic Positioning
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