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Next Generation Therapeutics for Human Repair and Regeneration
28

Bioquark Rodman & Renshaw Presentation 2012

Jul 05, 2015

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Bioquark, Inc., (www.bioquark.com) a biopharmaceutical company engaged in the development of proprietary biological drugs that can be simultaneously leveraged for both the regeneration and repair of human organs and tissues, CEO, Ira S. Pastor, presenting the Company’s overview at the Rodman and Renshaw Annual Global Investment Conference’s (14th Annual Healthcare Conference) on Thursday, September 11, 2012, at 10:00 a.m. Eastern time at the Waldorf Astoria Hotel in New York City.
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Page 1: Bioquark Rodman & Renshaw Presentation 2012

Next Generation Therapeutics for Human Repair and Regeneration

Page 2: Bioquark Rodman & Renshaw Presentation 2012

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.

Page 3: Bioquark Rodman & Renshaw Presentation 2012

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

Page 4: Bioquark Rodman & Renshaw Presentation 2012

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

Page 5: Bioquark Rodman & Renshaw Presentation 2012

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.

Page 6: Bioquark Rodman & Renshaw Presentation 2012

Humans Have Very Limited Regenerative and Repair Capacity

Page 7: Bioquark Rodman & Renshaw Presentation 2012

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

Page 8: Bioquark Rodman & Renshaw Presentation 2012

Pharmaceuticals Don’t Reverse Damage

Direct Killing

Transporter Interaction

Substance Replacement

Enzyme Interaction

Receptor Interaction

Page 9: Bioquark Rodman & Renshaw Presentation 2012

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

Page 10: Bioquark Rodman & Renshaw Presentation 2012

Clues From Nature

Page 11: Bioquark Rodman & Renshaw Presentation 2012

Epimorphosis

De-differentiation

Proliferation

Re-differentiation

Re-Integration Tissue Organization

Damage

Size / Positional Specification

Morphogenesis

Reprogramming

Page 12: Bioquark Rodman & Renshaw Presentation 2012

Oocyte - Biological Re-Start

Epigenetic Modifications Nuclear DNA Repair Morphogenesis

Mitochondrial DNA Repair

Infectious / Oxidative / Inflammatory Defense

Microenvironment Regulation

Telomere Control

Organelle Remodeling

Page 13: Bioquark Rodman & Renshaw Presentation 2012

Microenvironment Centric Embryo Blastema

Normal Fetus Normal Limb

Introducing foreign tissues

such as: - Stem Cells

- Somatic Cells - Cancer Cells

Abnormal

Page 14: Bioquark Rodman & Renshaw Presentation 2012

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

Page 15: Bioquark Rodman & Renshaw Presentation 2012

Heterogeneous Drugs

Page 16: Bioquark Rodman & Renshaw Presentation 2012

BQ-A - Melanoma Model

Page 17: Bioquark Rodman & Renshaw Presentation 2012

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

Page 18: Bioquark Rodman & Renshaw Presentation 2012

BQ-A - TBI Model

Control (No TBI) 14 days after TBI BQ-A treatment 14d

β-amyloid Immuno-histochemistry

Brain Gross Anatomy

Page 19: Bioquark Rodman & Renshaw Presentation 2012

BQ-A - TBI Model - Morris Water Navigation Task

Testing hippocampus impaired spatial learning and memory

Page 20: Bioquark Rodman & Renshaw Presentation 2012

BQ-A - Derm Applications Squalene Monohydroperoxide

Induced Wrinkling Model

Page 21: Bioquark Rodman & Renshaw Presentation 2012

BQ-A - Derm Applications Alopecia Model

Page 22: Bioquark Rodman & Renshaw Presentation 2012

BQ-A – Mouse Gerontology

Initiate chronic dosing

N=10 N=10

Page 23: Bioquark Rodman & Renshaw Presentation 2012

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

Page 24: Bioquark Rodman & Renshaw Presentation 2012

BQ-A - FSGS Development Plan

- Repair and regenerate podocytes - Induce clinical remission - as measured by reduction in proteinuria

2012 2013 2014 2015 2016

Page 25: Bioquark Rodman & Renshaw Presentation 2012

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)

Page 26: Bioquark Rodman & Renshaw Presentation 2012

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

Page 27: Bioquark Rodman & Renshaw Presentation 2012

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

Page 28: Bioquark Rodman & Renshaw Presentation 2012

Thank You

Ira S. Pastor CEO, Bioquark Inc.

[email protected]