biomoda presentation
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609 Broadway NEAlbuquerque, NM 87102Phone: 505-821-0875Fax: 866-519-6156Website: www.biomoda.com
Biomoda, Inc.Overview
June 2012
Forward-Looking Statements
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on estimates, projections, beliefs and assumptions of Biomoda management at the time of such statements and are not guarantees of future performance. Forward-looking statements involve risks and uncertainties in predicting future results and conditions. Actual results could differ materially from those projected in these forward-looking statements due to a variety of factors, including, without limitation, the acceptance by customers of our products, our ability to develop new products cost-effectively, our ability to raise capital in the future, the development by competitors of products using improved or alternative technology, the retention of key employees and general economic conditions. Forward-looking statements are made as of the date of this presentation and are subject to change without notice.
Medical diagnostics company developing an inexpensive, non-invasive, simple, and accurate cancer diagnostic. Strong international IP portfolio.
Biomoda, Inc. (Trading Symbol: BMOD)
Large cancer diagnostics market Company’s first commercial assay is
targeted for lung cancer Pilot trial completed: “Significant New
Biomarker” Optimization studies designed Technology potential:
targeted drug delivery vehicle therapeutic applications in-vivo imaging agent
Mechanism: Biomarker binds to lipoprotiens on cell membrane and fluoresces red using a proprietary labeling process
Biomoda’s CyPath®
TCPP-based assay preferentially binds to cancer cells and causes them to fluoresce red under ultraviolet light; distinct fluorescent signature allows objective reading of assay
5, 10, 15, 20 Tetra
Why Lung Cancer?
Lung cancer patients diagnosed in late stages• 5-year survival rate:
• 15% in US; 8% in Europe• Among lowest of all cancers
Early detection saves lives• 5-year survival rates:
• Breast 87%; Prostate 99%– Lung cancer diagnosis at Stage 1 92%*
LDCT has high false positive rate (up to 96%); companion diagnostic fills significant need
*ELCAP study NEJM, 2006
Market Size: Lung Cancer Diagnostic**
• USA: 44 Million current smokers• Europe: 215 Million current smokers• Japan: 30 Million current smokers
** Biomoda Patent Coverage includes U.S., Europe, Japan, Mexico, Canada & Australia
CyPath: Revealing the Unique Signature of Cancer Cells
Proof-of-Concept Clinical Trial CyPath® Lung Cancer Assay
– Significant new biomarker for lung cancer– Study differentiated between cancer cohort (26
diagnosed, not yet treated) and high-risk participants (102 military veteran smokers with at least 20-pack year history)
– Assay detects cancer from a sputum sample– Results obtained reading only 12 slides plated from
each sputum sample = approx. 600,000 cells read; full sample = 3 million+ cells possible for evaluation
Next Step: Assay OptimizationIncrease Biomarker’s Sensitivity & Specificity
Flow Cytometry: Develop cell-suspension assay to read entire sputum sample Cancer patient sample that tested false-negative in pilot study
(based on only 12 slides or 600,000 cells) resulted in true-positive when entire sputum sample was analyzed (3.5 million cells)
Patent Pending: Stabilization of light source leading to accurate, reproducible flow cytometry readings
Coating Concentrations: Optimal concentration to separate cancer from normal cells
Morphology: Determine spectral signatures of entire cell matrix
Incubation Time: Pairing various coating concentrations with incubation times to provide maximum separation of cancer cells
Partnerships: Academic
• Research and Funding Partnership with University of Texas Health Science Center at San Antonio (UTHSCSA)– Memorandum of Understanding signed in March 2011– Leading U.S. health science university; ranks in top 3% of all
institutions receiving federal funding– Focus on accelerating, facilitating, increasing discovery,
development and commercialization– Clinical research to Increase Sensitivity and Specificity by
automation, differentiation of fluorescent cell morphology, larger volume of sample analyzed with flow cytometry
– UTHSCSA Research teams will help accelerate application of assay to other cancers and indications
Partnerships: Medical Advisors
• Principal Investigator: Thomas Bauer, MD - Chief of Thoracic Surgery, Helen F. Graham Cancer Center & Christiana Care
• Sputum cytology: Dan Merrick, MD - Chief pathologist, VA Medical Center Denver
• Sputum collection: Tim Kennedy, MD - Pathologist, U of Colorado
• Lung cancer research: Marty Jacobson, PhD - Saccomanno Research Institute, St. Mary’s Hospital Medical Center
• Digital fluorescent cytology: Dino U. Vallera, MD - Medical Director and Chairman, Department of Pathology and Laboratory Medicine, University of Chicago, Pritzker School of Medicine
• Local PI and radiology: Lara Patriquin, MD - Diagnostic Radiologist, Radiology Associates, Presbyterian Hospital, Albuquerque, NM
Technology Potential: Multi-Cancers
Technology Potential: Targeted Drug Delivery
5, 10, 15, 20 Tetra
CyPath molecule, a porphryn compound, allows for attachment of metal or other toxic agent for targeted drug delivery and therapeutic applications
Patent Portfolio6,838,248 Compositions and Methods for Detecting Pre-Cancerous Conditions in Cell
and Tissue Samples Using 5, 10, 15, 20-Tetrakis (Carboxyphenyl) Porphine Issued 1/4/05, Expires 11/19/21
Notice of Allowance for Additional Claims under Divisional Application relating to 6,838,248 as root patent; Received 2/8/11
6,838,248Foreign patents Approved: Europe, Australia, Japan, Canada, & Mexico
7,384,764Method for Prognosing Response to Cancer Therapy with 5, 10, 15, 20-7,960,138 (CIP) Tetrakis (Carboxyphenyl) Porphine; Issued 6/10/08, Expires 9/2/24
7,670,799Compositions and Methods of Making 5, 10, 15, 20-Tetrakis (Carboxyphenyl) Porphine; Issued 3/2/10, Expires 6/5/24
12/839,283 System and Method for Analyzing Samples Labeled with 5,10,15,20 Tetrakis (4-Carboxyphenyl) Porphine (TCPP)
Application Published 1/20/11; Patent Pending
Pending Narrow Band Fluorophore Exciter, Submitted 11/3/11
Biomoda, Inc. (BMOD) Management Team•Maria Zannes - Chairman and CEO
30 years corporate managementUniversity of NM / Puget Sound (Seattle University) J.D.
•John J. Cousins - President and CFO 25 years corporate managementBoston University / MIT / The Wharton School, MBA
•Tim Zannes - General Counsel and Corporate Secretary20 years legal counsel and private practice University of North Carolina / University of NM, J.D.
•Gordon Bennett - Fluorescence/Biophotonics Microscopist15 years fluorescence imaging / spectroscopy Photonics and Biophotonics Department Chair, Central NM
Community College; Adjunct faculty, College of Santa FeUniversity of NM, B.S., physics and J.D.
609 Broadway NEAlbuquerque, NM 87102Phone: 505-821-0875Fax: 866-519-6156Website: www.biomoda.com
Thank You