Biomoda Roadshow Presentation

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    Biomoda Roadshow Presentation - Presentation Transcript

    1. 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
    2. 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
    3.  
    4.  
      • 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
    5.  
    6. 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
    7.  
    8.  
      • 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,
        • quality control, quality assurance, product support programs, product improvement programs, cost
        • 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
    9. 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
    10.  
    11. 609 Broadway NE Albuquerque, NM 87102 Phone: 505-821-0875 Fax: 505-293-1191 Website: www.biomoda.com Thank You
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