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.TRANSCRIPT
Diagnostic and Therapeutic Innovation
Abviva, Inc.402 East Gutierrez Street
Santa Barbara, CA 93101t: 800.970.5870 | f: 800.970.5874
www.abviva.com
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Abviva, Inc.402 East Gutierrez Street
Santa Barbara, CA 93101t: 800.970.5870 | f: 800.970.5874
www.abviva.com
www.abviva.com