Gamma Therapeutics Corporate Presentationgamma-therapeutics.com/images/GammaCorporatePresentation.pdfReceived 3-yr. $1.46 M NIH/SBIR Grant for GammaCoeur, Q3,2010. Submitting $1.5

Gamma Therapeutics Corporate Presentation

David Farrell, PhD

Founder & Chief Scientific Officer

David F. Eastman, MSc Chief Executive Officer

Confidential. All Rights Reserved

Gamma T H E R A P E U T I C S

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OVERVIEW

Gamma Therapeutics, incorporated in Oregon in

2009, is a biotechnology venture developing a novel

class of diagnostic test and surgical therapy solutions

for the cardiovascular disease industry.



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Gamma Therapeutics Science and Products



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PRODUCTS/IP STATUS

Non-immunogenic

anticoagulant,

shorter-acting blood thinner

for use during & after surgery

to reduce VTE risk.

High strength surgical

sealant for areas of

mechanical strain, i.e.,

large artery vascular

surgery & wound repair

Cardiovascular disease

(CVD) risk assay for

heart attack and stroke to

assist in prognosis and

early treatment

U.S. Patent #7,615,527 B2

U.S. Patent AP: #11/955,080

Provisional Patent Filed

Gammarin TM GammaSeal TM

GammaCoeur TM

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GAMMACOEUR g



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GammaCoeur™ addresses the need for a new cardiovascular disease (CVD) risk assay to complement traditional biomarkers such as cholesterol, triglyceride and glucose, for heart attack and stroke risk. Despite current tests, millions die each year from fatal heart attacks, many of which were preventable with more predictive testing methods. A simple non-invasive GammaCoeur blood test will give cardiologists more heart risk data and greater confidence in their prognosis and preventive care regimens. Business Opportunity: The value of the U.S. CVD market alone is $506 B, with $1.36 B spent on cardiac diagnostic testing.


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GAMMASEAL g

GammaSeal™ is a high strength surgical sealant, delivered as a spray or drip, for areas of mechanical strain, i.e., large artery vascular surgery or wound repair. The degradation-resistant features of GammaSeal offer significant benefits over existing incision sealants, some of which are subject to enzymatic breakdown by the body, and others that exhibit potentially life-threatening complications. The potential applications for an internal sealant that is strong, flexible and biocompatible, include surgical procedures in cardiovascular medicine, emergency response care and battlefield trauma. Business Opportunity: The global market for surgical incision closures is projected to reach US $7.7 billion by the year 2015.



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GAMMARIN g

Gammarin™ is a patented, non-immunogenic, short-acting anticoagulant blood thinner administered as an IV-infused drug before and after major surgery. Gammarin offers significant benefits over existing anticoagulants, particularly heparin when it is clinically contraindicated, such as in cases of heparin-induced thrombocytopenia. Gammarin is especially beneficial for patients undergoing major surgery, where the standard of care includes a large dose of prophylactic anticoagulants to prevent the formation of unwanted blood clots and the growth of existing clots which may form emboli. Business Opportunity: The worldwide market for anticoagulants, in 2010, is $6 B annually, growing to $14 B, by 2017.

TECHNOLOGY

The Gamma Therapeutics’ product platform is Gamma Prime

Fibrinogen, a natural occurring protein in human blood.

Characteristics:

JH Brown et al. (2000) PNAS 97:85



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--Carrier protein for factor XIII zymogen, (Siebenlist et al., 1996; Moaddel et al., 2000)

--Thrombin binding site, (Meh et al., 1996, 2001; de Bosch et al., 2002; Lovely et al., 2003; Pospisil et al., 2003)

--Forms clots that are resistant to fibrinolysis, (Falls & Farrell, 1997; Collet et al., 2004; Siebenlist et al., 2005)

--Associated with cardiovascular disease, (Drouet et al., 1999; Lovely et al., 2002; Mannila et al., 2007;

Cheung et al., 2009; Lovely et al., 2010)

gA Fibrin g' Fibrin


Flood et al. (2010)


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FIBRINOGEN Gamma Prime Fibrinogen (g’) Forms Thinner,

But Denser Fibrin Fibers

PROOF OF CONCEPT

•Penn State University CAD Study: g' Fibrinogen significantly associated with coronary artery disease. Individuals in the upper 25th %ile showed 7x increased odds of CAD. (Lovely et al. Association of gA/g' Fibrinogen Levels and Coronary Artery

Disease. Thrombosis and Haemostasis 2002; 88: 26-31)

•Stockholm Coronary Artery Risk Factor Study: g' study showed elevated levels associated with early onset heart attacks before age 60. (Mannila et al.

Elevated Plasma Fibrinogen g’ Concentration Increases Risk of Myocardial Infarction: Effects of Genetic Variation in Fibrinogen Genes and Environmental Factors. Journal of Thrombosis and Haemostasis 2007; 5: 766-73)

•Framingham Heart Study: g' Fibrinogen study with 3,400 individuals showed people in upper 33rd %ile of g' fibrinogen and upper 33rd %ile of total fibrinogen showed a 3x increased odds of heart attack. Validated the test for its linearity, precision, analytical specificity, lower limit of quantification, reference interval, reproducibility, sensitivity, and specificity. (Lovely et al. g' Fibrinogen: Evaluation of a New Assay for Study of Associations with Cardiovascular

Disease. Clinical Chemistry 2010; 56: 781-8)



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Gamma Therapeutics Business Model



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BUSINESS MODEL

Gamma Therapeutics (GT) has no plans to be an original manufacturer (OEM) of its products and will focus on its core competencies in research and product development, licensing its products for manufacturing, marketing and distribution through strategic partner agreements, worldwide.

It will develop a host of new commercial products to address the need for diagnostic testing and surgical therapy solutions in the fast growing cardiovascular disease (CVD) market.

PARTNER/SALES MODEL

Private/Public

Cardiology Research

Physician Office Clinical Labs

Public Diagnostic

Labs

Customers

Contract Research Organizations

Gov’t Diagnostic

Labs

Private Diagnostic

Labs Product R&D Company developing point-of-care diagnostic testing & post-surgical therapy products for the CVD industry. Develop products from lab to FDA approval than provide royalty- Bearing, non-exclusive licenses for manufacture, marketing & sales.



Product Licensees Diagnostic Product Mfg.

Strategic Development Partner Global IVD Distributor

Gamma

T H E R A P E U T I C S

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FLAGSHIP PRODUCT

Gamma Therapeutics’ flagship product is GammaCoeur, a novel CVD Risk Assay designed to complement traditional cardiac biomarkers on the market today.

Benefits:

Gives cardiologists, hematologists and primary care physicians enhanced predictive data related to heart attack and stroke risk.

Provides a 3X cardiac risk score vs. 2X score when HDL/LDL Cholesterol levels are tested. Cholesterol tests are considered the gold standard.

Once approved, will be available on multiple assay platforms for use in diagnostic test systems commonly in use in commercial diagnostic labs.

Supports new health care laws and initiatives to encourage point-of-care diagnostic devices, and reduce the use and cost of drug regimens and invasive CVD surgery.


FLAGSHIP PRODUCT MILESTONES

Proof of Concept

2002

Filed Provisional

Patent

Q1, 2010

GammaCoeur Development g

Set Up Assay

Development Lab,

Q3,2010

Conjugate Beads with

Monoclonal Antibody

Q4,2010

FDA Trial/Approval

Specificity, QC

Sensitivity Test,

Q1/2011

Luminex/ELISA

Prototype Platform,

Q2,2011

Manufacturing,

Q2,2013 Launch Product,

Q3, 2013

Submit Pre-IDE

Q3, 2011

Target BETA Sites

Q2,2011

Full Patent Acquired

Q2, 2012

CVD Market Sales,

2013>

BETA testing

Q3, 2011

FDA Approved/CPT Assigned

Q1,2013

BETA Testing

Completed/Submitted,

Q3, 2012


MARKET SIZE

Confidential. All Rights Reserved Confidential. All Rights Reserved


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$27 M to $136 M

GammaCoeur g

Cholesterol/Glucose/Triglyceride Tests $269 M to $1.36 B

Preventive Care/Heart Drugs Hospitalization/Surgery

U.S. CVD Market Spending $506 B, 2010 Diagnostics/Tests Physician Visits/Ins.

14 Million Heart

Risk Diagnostic Tests

NOTE: The value of the general IVD market, including cardiovascular-related diagnostics, in 2009 was nearly $30 B, and it is estimated to reach $50 B in 2012—according to Decision Resources.

PRICING BASIS



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2010 2011 2012 2013 2014 2015

Assay Kits 0 2500* 5000* 110,000** 350,000 775,000

SBIR Funds $514,223

$514,223 $514,223 $0 $0 $0

Revenues $0 $0 $0 $10,000,000~ $35,000,000~ $77,500,000~

COGS+ $0 $25,000 $50,000 $1,100,000 $3,500,000 $7,750,000

FDA Fees-Beta Tests

$60,000 $51,000 $250,000 $500,000 $0 $0

Operating Costs

$454,223 $438,223 $464,223 $1,688,000 $3,275,000 $10,876,000

Net Income (loss)

$0 $0 ($250,000) $6,712,000 $28,225,000 $58,874,000

*Includes kits provided free for Beta Testing and research purposes.

**Does not include potential costs of setting up full manufacturing capabilities, people and facilities ~ Does not capture possible VC/equity investment in Gamma Therapeutics, after 2012 ^ All numbers are based on direct sales, and do not adjust for royalty income from licensees or payments

REVENUE



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5-Year Revenue Projections Based on Retail

Sales of GammaCoeur Assay Kits Only.

SWOT ANALYSIS



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FUNDING

Received 3-yr. $1.46 M NIH/SBIR Grant for GammaCoeur, Q3,2010.

Submitting $1.5 M DARPA/NIH SBIR grants for GammaSeal, Q2,2011.

Signing collaborative product development agreement with

Healthcare Diagnostic Laboratory to include related costs.

Other funding sources:

Venture Investment: Will begin talks with life science VCs in Winter, 2012, if VC monies needed.

Partner Investment: Currently engaged with HDL, Alere Medical, Diagnostica Stago, Amgen, Merck Pharmaceuticals.

Product Revenue: Can sell prototype GammaCoeur assay for cardiac research purposes only.



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COMPANY MILESTONES


Gamma Incorporated,

10/2009

Partner Discussions,

Stago, HDL, 10/2010

Alere, Merck, Amgen,

01/2011

Hired CEO, CSO

7/2010

Launched Company

09/2010

Awarded $1.46

SBIR Grant, 05/2010

Hired Senior Scientist,

09/2010

Develop GammaCoeur

Platform, 04/2011

Completed Licensing

Agreements, 10/2010

Signed HDL Partner

Agreement, 02/2011

Submit pre-IDE to FDA

OIVD, , 06/2011

Begin BETA Testing

07/2011

Company Status-2011

VC/Angel Fundraising*

Q2,2012-2013

*VC Money, if needed

License Strategic/

Channel Partners

Q4,2011-Q1,2013


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David Eastman, MSc CEO

Candace Clement Controller (Contractor)

David Farrell, PhD Founder & CSO

Scientific Director (Open)

Legal Counsel TonkonTorp

Research & Development

Board of Science Advisors

Jon Oberdorf, PhD Assay Development Senior Scientist

Human Resource Management (Contractor)

Stephen Kazmierczak, PhD BETA Test/FDA Coordinator

Jordan Phillips Website/Designer (Contractor)

GammaCoeur Product Mgr (Partner)

ORGANIZATION

Graduate Intern Laboratory Asst.

(Open)



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MANAGEMENT

David Farrell, PhD, Founder & Chief Scientific Officer Professor of Medicine, Division of Cardiovascular Medicine, Oregon Health & Science University. 31 years in the field of blood coagulation research, 17 as a Principal Investigator. BS in Biochemistry, UCLA, PhD in Biological Sciences, Univ. of California, Irvine. Former Asst. Professor Biochemistry & Molecular Biology, Penn State University College of Medicine; former Chair, SBIR grants study section, NIH David F. Eastman, MSc, Chief Executive Officer Former CEO, Yecuris Corporation. 25 years of Life Science, biotech and medical device go-to-market strategies, business development, strategic relationships and venture funding with leading medical companies, i.e., Becton Dickinson, Cordis Dow Medical, Fresenius and 24 medical start-ups, MSc, Marketing, University of Oregon and UCLA.



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BOARD OF SCIENCE ADVISORS

Kent Thornburg, Ph.D., M. Lowell Edwards Professor of Medicine Director, OHSU Heart Research Center Sanjiv Kaul, M.D., Distinguished Professor of Cardiology, and Division Head, OHSU Division of Cardiac Medicine Steven Kazmierczak, DABCC, Ph.D., Professor and Director, Clinical Chemistry & Toxicology, OHSU Department of Pathology Lt. Col. Martin Schrieber, M.D., Professor of Surgery, Chief, Trauma, Critical Care and Acute Care Surgery, OHSU Director of Adult ICUs. José López, M.D., Executive Vice President for Research, Puget Sound Blood Center, Research Division



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Contact Us

For Science & Product Information

contact: David Farrell, PhD

Founder & Chief Scientific Officer [email protected]

503.222.2314



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For Business & Investment Information

contact: David Eastman, MSc

Chief Executive Officer [email protected]

503.222.2313

mailto:[email protected]






Documents

Gamma Therapeutics Corporate Presentationgamma-therapeutics.com/images/GammaCorporatePresentation.pdfReceived 3-yr. $1.46 M NIH/SBIR Grant for GammaCoeur, Q3,2010. Submitting $1.5