609 Broadway NE Albuquerque, NM 87102 Phone: 505-821-0875 Fax: 505-293-1191 Website: www.biomoda.com Biomoda, Inc. Corporate Presentation August 2009
An Albuquerque, New Mexico based medical diagnostics company that has developed an inexpensive, non-invasive, simple, and accurate test for early cancer detection based on a proprietary molecular marker platform.
Large unmet medical need
Clinical Trial development stage (Phase II)
Strong IP portfolio
Proven management team
Platform for other cancer diagnostic applications
Lung – Initial Product
Cervical
Colorectal
Breast
Cancer is the second leading cause of death by disease in the U.S. CDC: Cancer: 559,888
Lung cancer
Leading cause of cancer deaths
60% of lung cancer patients die within one year of diagnosis
Most expensive cancer to treat
(1) ELCAP Study New England Journal of Medicine (2006)
In 2007, cancer was responsible for an estimated 7.6 million deaths worldwide
World Health Organization predicts 50% rise in cancer incidence by year 2020
Source: B.B.C. Media UK
No Screening Protocol Available Patient tested only when symptoms are present: Resulting in Stage III-IV diagnosis 15% 5 year survival rate
T hanks to significant federal and state investments over the
past 35 years in research and early detection, the 5 year
survival rates for breast, prostate and colon cancers are
now 87%, 99% and 65% respectively.
Lung cancer remains at 15%
Senate Resolution to fund Lung Cancer screening May
2006 because survivability has not improved
ELCAP study NEJM October 2006
Identifying LC in Stage 1 increase 5 year 15% to 92%
Altering course of care/therapy routes
Resection
Pathway inhibitors: defined through genomics
Radiology/Chemo-therapy
Lifestyle changes: smoking cessation
Technology originally developed at Los Alamos National Laboratory
TCPP preferentially binds to cancer cells and fluoresces red when excited with UV light 5, 10, 15, 20 Tetrakis (Carboxyphenyl) Porphine
Deep Lung sputum sample collected using the Lung Flute
Sample collected into a sterile collection cup
Sample transported to lab at room temperature
Sample processed onto a microscope slide using ThinPrep 2000 slide processor
Processor makes a monolayer of subjects cells onto microscope slide
Slide is incubated in CyPath® labeling solution
Slide is then prepared for viewing under microscope
New device that provides accurate image captures and enhanced data set
Eliminates background florescence and other noise
Captures at the subcellular, cellular and tissue level
Cancer
Normal
100% specificity (12/12) 100% sensitivity (15/15) Blind Sample Number of Patients Number of positive red Fluorescent cells Normals 12 0 Lung Cancer 15 15
Unique Dataset Collected
Participant Modality Comparison:
CT scan/read
PAP cytology analysis
CyPath® results
Data from 125 participants compiled
Longitudinal Component Started
Follow-up 3, 6, 9, & 12 month
$1.65 million appropriated by NM State Legislature to screen military veterans for early stage lung cancer
Screening tool is Biomoda’s proprietary CyPath ® assay
Currently completing Phase 2 clinical trial
Phase 3: Multi-site; up to 3500 participants
End point: 50 asymptomatic Lung Cancer
FDA submission; 9 months to approval
Reimbursement: there are CPT codes for the various components of the test that are already approved
CPT coding study: $75 - $175
Biomoda estimate: $100 per test
COGS 50%: lab overhead; supplies; analytics
Stage 1 – Internal Testing
Revenue driven via single use components
Peer Review Journal Articles and Study Reports
Poster Sessions and Medical Conference Presentations
Contract Sales force to “detail” doctors
Stage II – Out License
Strategic Alliance with Regional/National Labs
Licensing of Clinical Labs - Quest, Labcorp, etc. to do testing.
Expansion to machine testing to reduce cost
Government sales:
US Veterans Administration
Active military
FDA approval:
Sales to general public as annual screening test (like PAP and PSA tests)
European and Japanese markets
Similar staged strategy for other cancers:
cervical, bladder, colorectal, & breast
John J. Cousins - President and CEO
25 years experience starting as an electronics engineer up to his current role as executive and
Entrepreneur.
MBA from The Wharton School and undergraduate degrees from Boston University and MIT
Tim Zannes - General Counsel
University of North Carolina and the University of New Mexico where he earned his J.D. degree
Constance Dorian - Vice President of Technical Operations
20 years experience in the design and development of In Vitro diagnostic assays, clinical studies,
reduction programs, contract negotiations, inventory control, and production planning following FDA
Guidelines
B.S. in Biology from San Diego State University
Angela Martinez Cancer Research Associate
B.S. in Biology and a B.A. in Spanish from the University of New Mexico. She is currently working
towards an M.S. in Health Education. Her experiences lie in the coordination, conduction, and analysis
of environmental and clinical research
Gordon Bennett - Fluorescence/Biophotonics Microscopist
B.S. in physics as well as a J.D. from UNM. His background is in photonics and electronics. He has been
adjunct faculty at the College of Santa Fe and has held the Chair in Photonics and Biophotonics at CNM. He is
currently a member of the Optical Society of America and the New Mexico State Bar.
Verrity Gershin - Corporate Secretary & Director of Administration
Bachelors degree from the University of New Mexico
Eleven years of experience in accounting and SEC filings
John J. Cousins – President, CEO, & Director
Maria Zannes - Director
30 years experience in the environmental and energy industries—from federal lobbyist to company president. Formerly the president of the national waste-to-energy trade group in Washington, D.C., Ms. Zannes currently consults for private clients in the medical and environmental industries
Ms. Zannes is licensed to practice law in Washington State and New Mexico
David Lambros - Director
Practiced law for more than 25 years and served on various boards, including Commerce Exchange Bank and Southwest General Hospital. David presently is a director on the Systems Board at Southwest General Hospital, a multi-million dollar company
Lewis White - Director
Director and CEO of New Energies Nebraska, LLC, a subsidiary of Standard Alcohol Company
Thomas Bauer, MD- Chief of Thoracic Surgery, Graham Cancer Center, U of Delaware
Dan Merrick , MD- Chief Cytopathologist, VAMC Denver
Tim Kennedy, MD- Pathologist, U of Colorado
Lara Patriquin, MD- Chief of CT Radiology, RAA
Ramesh Gopal, MD- Chief of Radiology Oncology, MD Anderson
Steve Groshang, MD PhD- Pathologist, Head of Pathology Laboratories, National Jewish Health
Marty Jacobson, PhD- Saccommanno Institute R & D
Symbol: BMOD (trades on OTC Bulletin Board) Recent Price: $0.30 Shares Outstanding: 77.5 million Market Capitalization: $23 million Revenue Projections: Unit Sales Revenue Year 2010 2011 2012 2013 2014 US – Lung 10,000 130,000 200,000 250,000 312,500 Europe - Lung 80,000 200,000 250,000 312,500 Japan – Lung 20,000 120,000 150,000 187,500 Total 10,000 230,000 520,000 650,000 812,500 $ Rev. @ $100/Test $1.0 M $23.0 M $52.0 M $65.0 M $81.25 M
609 Broadway NE Albuquerque, NM 87102 Phone: 505-821-0875 Fax: 505-293-1191 Website: www.biomoda.com Thank You
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