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Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

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Abviva, Inc. was established to develop and commercialize diagnostic and therapeutic products from a novel breast cancer growth inhibitory protein. Research scientists at the prestigious University of Michigan Cancer Center discovered a secreted protein produced in normal breast epithelial cells that inhibits the growth of breast cancer.
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Diagnostic and Therapeutic Innovation Abviva, Inc. 402 East Gutierrez Street Santa Barbara, CA 93101 t: 800.970.5870 | f: 800.970.5874 www.abviva.com
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Page 1: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

Diagnostic and Therapeutic Innovation

Abviva, Inc.402 East Gutierrez Street

Santa Barbara, CA 93101t: 800.970.5870 | f: 800.970.5874

www.abviva.com

Page 2: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

FORWARD LOOKING STATEMENTS

Statements in this presentation that are not strictly historical facts are “forward looking” statements (identified by the words “believe”, “estimate”, “project”, “expect” or similar expressions) within the meaning of the Private Securities Litigation Reform Act of 1995. These statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company’s products and services in the marketplace, competitive factors, changes in the regulatory environment, and other risks detailed in the Company’s periodic report filings with the Securities and Exchange Commission. The statements in this presentation are made as of today, based upon information currently known to management, and the Company does not undertake any obligation to publicly update or revise any forward-looking statements.

Page 3: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

Breast Cancer Risk Assessment

Mammastatin Serum Assay (MSA)

MSA Is A Simple Blood Test

Clinical Studies Demonstrate Value

Patented Technology

Exclusive License

MSA Assay Developed

Commercialize Current MSA - CLIA

$3.3 Billion US Addressable Market

Mammastatin Serum Assay

Page 4: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

Mammastatin Serum Assay

Favorable PSA Assay Statistical Comparison

Screening Test Sensitivity Specificity

Negative

Predictive

Value

Positive

Predictive

Value

Accuracy

Mammastatin Serum

Assay (MSA) 71% 86% 98% 25% 85%

Prostate-Specific

Antigen Assay (PSA)68% - 80% 60% - 70% 98% 30% 67%

PSA Assay Statistical Performance References:

“Prostate-Specific Antigen (PSA) Best Practice Policy” Oncology Vo. 14, No 2 (February 6, 2000)

“Predictors of Prostate Carcinoma: Accuracy of Gray-Scale and Color Doppler US and Serum Markers” Radiology. 2001; 220: 757-764

“Prostate Screening – Learn More: Accuracy of the PSA Test” http://www.realage.com/health_guides/ProstateCancer/topics/fs_topics.asp?memberId=&cbr=&topic=23

Page 5: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

Mammastatin Science

Science Of Mammastatin:

Normally Present In Healthy Women

Secreted From Breast Epithelial Cells

Inhibits Growth of Breast Cancer Cells

Detected In Peripheral Blood Serum

Published In Scientific Journals

Science 1989

IVD Technology – MSA – 2003

High Levels (Normal) ~ Low Risk

Low Levels (Not Normal) ~ High Risk

Page 6: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

Mammastatin US Patent Portfolio

ISSUED US

PATENTS PATENT NAME

6,451,765 Methods for Treating Breast Cancer Using Mammastatin

6,492,504 Nucleotide Sequence of Mammastatin and Methods of Use

6,500,937 Nucleotide Sequence Encoding a Mammary Cell Growth Inhibitor

6,599,495 Nucleotide and Protein Sequence of Mammastatin and Methods of Use

7,256,277 Nucleotide and Protein Sequence of Mammastatin and Methods of Use

7,323,173 Methods for Treating Breast Cancer Using a Mammary Cell Growth Inhibitor

7,332,287 Methods and Compositions for Diagnosing Breast Cancer

Page 7: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

No Equivalent Risk Assessment Test Available Today

Simple, Cost Effective Broad-Based Population Screening

Global Market Potential:

US Target Market: 82 Million Women Over 30

500 Million Women Worldwide*

US Addressable Market: Women > 30 Yrs. Getting Annual Mammograms

48 Million in US

Over $3.3 Billion US Addressable Market

Predictive Screening Growing In Popularity

Benefits Of Earlier Breast Cancer Detection: Higher Survival Rate – Up To 98%

Reduction In Death Rate

Lower Health Care Costs

Breast Cancer Screening Market

• Women With Access To Health Care• National Health Interview Survey Public Use Data File 2005, National Center for Health Statistics, Centers for Disease Control and Prevention, 2006; • American Cancer Society, Surveillance Research, 2007• Breast Cancer Facts & Figures 2007 – 2008; American Cancer Society• Algood et al. (2007) British Journal of Cancer

Page 8: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

Breast Cancer Testing

Breast

Cancer Test

Type Use Benefits Disadvantages Cost

Mammogram Diagnostic

Imaging

Identifies Masses For

Follow Up and Biopsy To

Confirm Breast Cancer

Screening Standard

Identifies Masses

Radiation Exposure

False Positives

Difficult On Dense Breasts

$100 - $150

Ultrasound Diagnostic

Imaging

Identify Masses For Follow

Up and Biopsy To Confirm

Breast Cancer

Adjunct To Mammography

Preferred For Dense

Breasts

Lower False Positive Rate

Not Mammogram Substitute

Limited Access Early In

Adoption Cycle

$150 - $450

MRI Diagnostic

Imaging

Identifies Masses For

Follow Up and Biopsy To

Confirm Breast Cancer

High Resolution

Better Identification

Pin-point accuracy

Radiation Exposure

Many False Positives

Costly

$1,000 - $1,500

BRCA-1; BRCA-2 Genetic Test –

Blood Test

Positive result indicates

mutations in BRCA gene

associated with breast

cancer predisposition

Blood Test

Accurate if gene present

Positive Indicates High

Risk

1 in 800 people have gene

Genetic Screening Issues

Negative test does not rule

out breast cancer

$300 - $3,000

Her-2/neu Tumor Marker-

Blood Test

Indicates how aggressive

breast cancer may be, and

indicates Herceptin

treatment

Specific for Her-2/neu

positive breast cancer

Rresponse to Herceptin

Blood test

After Cancer Diagnosed

< 12% of breast cancers

Not adequate for screening

$50 - $100

Oncotype Dx Test Estrogen

Receptor Test

– Tissue Test

Sets guidelines for hormone

therapy, and evaluates risk

of cancer recurrence

Indicates therapies if tumor

influenced by hormones

Tissue Sample

Not adequate for screening

Use After Cancer Diagnosed

$3,500

Mammastatin

Serum Assay

Blood Test Measure mammastatin High

Levels = Low Risk

Low Levels = High Risk

Simple Blood Test

Identify High Risk Women

Efficacy Demonstrated

Universal Screening

Access

Therapeutic Monitoring

Test for future mammastatin

drug

Pre-Launch Assay

Early Clinical Validation

Mammastatin Mechanism of

Action Uncertain

CLIA Only Test Today

Initially Private Pay

$150

Page 9: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

Commercial Development Timeline

Launch Current MSA Test

Retrospective Study

Commercial Launch

ASR Designation

Submit ASR Application

FDA Approval

Lab Partner & National Distribution

FDA MSA PMA

File PMA I (Mfn.) Start Clinicals

File PMA II (Data)

File Original PMA

FDA Approval

Insurance Reimbursement

International Distribution

FDA MSA Test Kit 510(k)

Test Kit Developed

Clinical Studies

File 510(k)

FDA Approval

2010 2011 2012 2013 2014 2015

Page 10: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

Breast Cancer Diagnostic Test

Mammastatin Serum Assay (MSA) Operating and Financial Targets*: Revenue in 2nd Quarter 2011

Positive Cash Flow in 2011

Accelerated Growth Rate in Year 3

Year 5 Targets*: + $200 mm Revenue

Sustainable Double Digit Earnings

Market Value ~ 25 to 35 P/E Multiple

Page 11: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

MSA Test Summary

Patented Breast Cancer Risk Assessment Diagnostic

Addresses Unmet Medical Need

Large Global Market Opportunity

Initial Diagnostic Technology Validated

Serum MSA Test Ready for Commercialization

Well Defined, Achievable Commercial Development

High Value Commercial Opportunity

Page 12: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

Mammastatin Breast Cancer Therapy

Protein Present In Healthy Women Secreted From Breast Epithelial Cells

Early Protein Replacement Therapy 29 Women Treated - Compassionate Use

Compelling Patient Results Palliative Stage IV Breast Cancer Patients

Physical Health of Women Improved

Metastatic Tumor Reduction – Bone Scans

Lives Extended Months to Years

Women Survived On Therapy Until Study Ended Up To Two+ Year Survival After Therapy Initiated

All Expired Within 6 Months After Studies Ended

Page 13: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

Development Milestones

Re-Establish Biologic Activity In Cell Culture

Ablation Study - Same Monoclonal Ab As MSA Assay

Development Concurrent With MSA Development

Develop Recombinant Protein

Manufacturing Through Phase I/II

Complete Pre-Clinical Studies

Submit To FDA For Accelerated Status

Initiate Phase I/II Trials

Page 14: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

Rationale For Rx Development

Published Research: Protein Secreted By Breast Epithelial Cells

Published Research: Strong Anti-Cancer Growth Inhibition

Human Dx Studies: Protein Normally Present In Women

Human Dx Studies: Protein Absent In Breast Cancer

Human Rx Studies: Compassionate Use on 29 Women

Human Rx Studies: Lives Extended During Therapy

Human Rx Studies: Metastatic Tumors Reduced (Bone Scan)

Physician Observations: Patient Overall Health Improved

Physician Observations: Placebo Effect Impossible

Page 15: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

Commercial Stage Breast Cancer Risk Assessment

Breast Cancer Therapeutic Drug Demonstrated

Concomitant Therapeutic Monitoring Assay

Exclusive IP & Patent Protection

Diagnostic Products At Commercial Stage

Experienced Management

MSA Revenues in 2011 *

Address Large Global Markets & Unmet Needs

Large Capital Appreciation Potential

* Assumes Financing in Q3 2010

Page 16: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

Executive and Financial Management

Business Development

Financing and Liquidity

Corporate Structure and Management

Breast Cancer Risk Assessment DiagnosticA Wholly Owned Subsidiary

Mammastatin Serum Assay Business

Incorporate In 2011Develop Mammastatin Therapeutic Assets

Page 17: Abviva, Inc. (PK ABVV) presentation OneMedForum-New York

Abviva, Inc.402 East Gutierrez Street

Santa Barbara, CA 93101t: 800.970.5870 | f: 800.970.5874

www.abviva.com

www.abviva.com


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