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6. keynote david dodd vaxy gen, geovax


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6. keynote david dodd vaxy gen, geovax

  1. 1. GeoVax Labs, Inc. October 14, 2011 Greater Rome Chamber of Commerce 2011 Technology Symposium O11_IRG
  2. 2. <ul><li>Comments made today contain forward looking </li></ul><ul><li>statements as described under the Private Securities </li></ul><ul><li>Litigation Reform Act of 1995. Our forward looking </li></ul><ul><li>statements represent our current view and are subject to </li></ul><ul><li>risks and uncertainties. These risks include the risk that </li></ul><ul><li>we may not be able to obtain needed funding, that the </li></ul><ul><li>products we have under development may not prove </li></ul><ul><li>successful, and other risks including those set forth </li></ul><ul><li>under “risk factors” in our Form 10-K and our other </li></ul><ul><li>SEC filings. </li></ul>Disclaimer
  3. 3. SOURCE: 2009 Report on the Global AIDS Epidemic, UNAIDS/WHO (December 2009) Total Living with HIV: 33.4M Total Clade B: 3.5M New Infections: 2.7M New Clade B:185,400 HIV/AIDS – A Continuing Global Challenge O11_IRG / North America 1.4 M 55,000 NEW Caribbean 240,000 20,000 NEW Latin America Clade B 900,000 76,500 NEW Western/Central Europe 850,000 30,000 NEW Middle East / North Africa 310,000 35,000 NEW Sub-Saharan Africa 22.4M 1.9 M NEW Eastern Europe/ Central Asia 1.5 M 110,000 NEW South/Southeast Asia 3.8 M 280,000 NEW Oceania 59,000 3,900 NEW East Asia 850,000 75,000 NEW Latin America Other 900,000 93,500 NEW B B B B C C C
  4. 4. SOURCE: CDC Fact Sheet – Estimates of New HIV Infections in the United States (August 2008) Current Rate of New Infection:55,000-58,000 per year * Estimated Cost for Each U.S. Infection = $500,000 (Aggregate, $27.5 billion/year) * AIDS 2010 Annual Meeting (Atlanta GA) Estimates for New HIV Infections in US O11_IRG / 0 1979 1983 1987 1989 1993 1997 2001 2005 20,000 40,000 60,000 80,000 100,000 120,000 140,000
  5. 5. Impact of a Preventative AIDS Vaccine A 50% effective vaccine given to just 30% of the population could cut the 33 million projected number of new HIV infections in the developing world by more than half over 15 years. SOURCE: AIDS Vaccine Blueprint 2006, IAVI Report NOTE: Polio Vaccine is 60-70% effective / Flu Vaccine 70-90% effective O11_XTRA / NO VACCINE Vaccine Introduction 4.0 3.5 3.0 2.5 2.0 1.5 1.0 0.5 0.0 2010 2015 2020 2025 2030 30% Efficacy 20% Coverage 50% Efficacy 30% Coverage 70% Efficacy 40% Coverage Total New Infections Averted by an AIDS Vaccine between 2015 - 2030 5.5 Million 17 Million 28 Million
  6. 6. Total Annual Global Revenue* Projections for 1 st Generation AIDS Vaccines * Only Preventative Vaccine Revenue Reported; Therapeutic Market Estimated at $3.6B US/$3.6B ROW SOURCE: IAVI, October 2007 HIV/AIDS Preventative Vaccine Market O11_IRG / SCENARIO HIGH OPTIMISTIC BASELINE BASELINE LOW Peak Global Revenue $5.5B $4.8B $4.5B $2.5B Avg. Annual Sales Revenue (over years 0-30) $4.3B $3.2B $2.6B $1.4B Cumulative Sales Revenue over 30 year period $134.4B $98.4B $81.7B $43.8B 6 5 4 3 2 1 0 0 5 10 15 20 25 30 Years since FDA/EMEA regulatory approval
  7. 7. <ul><li>Preventative HIV/AIDS Vaccine </li></ul><ul><ul><li>Vaccine Used Before Infection </li></ul></ul><ul><ul><li>Proposed Universal Vaccine (Hepatitis, Polio, DPT) </li></ul></ul><ul><ul><li>Completing Phase 2a (Q4 2011) </li></ul></ul><ul><ul><li>Planning Phase 2b Efficacy Trial </li></ul></ul><ul><li>Therapeutic HIV/AIDS Vaccine </li></ul><ul><ul><li>Reduce Need for Drugs </li></ul></ul><ul><ul><li>Vaccine Used After Infection </li></ul></ul><ul><ul><li>Phase 1/2 Trial Enrolling </li></ul></ul><ul><li>Strong Government Support ($$) </li></ul><ul><ul><li>Research & Development </li></ul></ul><ul><ul><li>Clinical Trials </li></ul></ul><ul><li>IP Exclusively Licensed from Emory University </li></ul><ul><ul><li>6 issued / 5 pending US patents </li></ul></ul>GeoVax Company Overview O11_IRG /
  8. 8. <ul><li>Robert T. McNally, Ph.D., President & CEO </li></ul><ul><ul><li>Co-Founder: CryoLife, Inc. & Cell Dynamics, LLC </li></ul></ul><ul><li>Harriet L. Robinson, Ph.D., Chief Scientific Officer </li></ul><ul><ul><li>GeoVax Co-Founder, Emory University, University of Massachusetts </li></ul></ul><ul><li>Mark W. Reynolds, CPA, Chief Financial Officer </li></ul><ul><ul><li>CytRx Corporation, Arthur Andersen & Company </li></ul></ul><ul><li>Mark J. Newman, Ph.D., Vice President of R&D </li></ul><ul><ul><li>PaxVax, Inc., Pharmexa, Inc., Epimmune, Inc. </li></ul></ul>GeoVax Corporate Management O11_IRG /
  9. 9. <ul><li>David A. Dodd, Chairman </li></ul><ul><ul><li>VaxyGen, Serologicals, Solvay, Wyeth, BMS, Abbott </li></ul></ul><ul><li>Harriet L. Robinson, Ph.D., Chief Scientific Officer </li></ul><ul><ul><li>GeoVax Co-Founder and CSO, Emory University, University of Massachusetts </li></ul></ul><ul><li>Robert T. McNally, Ph.D., President & Chief Executive Officer </li></ul><ul><ul><li>GeoVax President/CEO, Co-Founder: CryoLife Inc. & Cell Dynamics LLC </li></ul></ul><ul><li>Steven S. Antebi </li></ul><ul><ul><li>Maple Capital Management, Galileo Partners, Bear Stearns </li></ul></ul><ul><li>Dean G. Kollintzas </li></ul><ul><ul><li>Intellectual Property Attorney </li></ul></ul><ul><li>Jack N. Spencer, Jr., CPA </li></ul><ul><ul><li>Ernst & Young </li></ul></ul>GeoVax Board of Directors O11_IRG /
  10. 10. COMPLETE PLANNED Product Portfolio O11_IRG / NOT REQUIRED
  11. 11. Preventative Vaccine
  12. 12. <ul><li>Designed to Vaccinate HIV Uninfected People </li></ul><ul><ul><li>Prevent Infection & Reduce Transmission </li></ul></ul><ul><ul><li>Potential Universal Vaccine with Global Need (Hepatitis B, Polio, DPT) </li></ul></ul><ul><li>Phase 2a Trial – Enrollment Completed </li></ul><ul><li>Phase 2b Efficacy Trial; GM-CSF Adjuvanted Vaccine (begin, 2013) </li></ul><ul><li>GM-CSF Adjuvanted Vaccine </li></ul><ul><li>Immune Stimulator in Provenge ® (Cancer Vaccine) </li></ul><ul><li>Enhances Prevention of Infection </li></ul><ul><li>Clinical Trials Accelerated Based on Outstanding Pre-Clinical Data </li></ul><ul><li>Expanded Government Support </li></ul>GeoVax Preventative AIDS Vaccine O11_IRG /
  13. 13. Phase 1 Human Trial – Government Supported Published by The Journal of Infectious Diseases Challenge Dose 30-300 Times Higher Than Typical Human Dose DNA Vaccine with GM-CSF Adjuvant (Primate Data) O11_IRG / 0 80 100 60 40 20 Number of Challenges 0 2 4 6 8 12 10 Percent Uninfected 70% Prevention of Infection 5 / 7 No Evidence of Infection – To Date >12 Months 100% Infection Controls (0 / 15 Protected)
  14. 14. Therapeutic Vaccine
  15. 15. <ul><li>Designed to Treat HIV Infected People </li></ul><ul><ul><li>Protect Individuals from Progressing to AIDS </li></ul></ul><ul><ul><li>Reduce Reliance on Oral Medication </li></ul></ul><ul><ul><li>Reduce Cost and Drug Related Side Effects </li></ul></ul><ul><li>Phase 1/2 Trial Enrolling </li></ul><ul><ul><li>Evaluating Safety </li></ul></ul><ul><ul><li>Collecting Immune Response Data </li></ul></ul><ul><ul><li>Evaluate Effect on Viral Load </li></ul></ul><ul><li>Compelling Pre-Clinical Results </li></ul>GeoVax Therapeutic Vaccine O11_IRG /
  16. 16. Unpublished Data: Dr. Rama Amara & Dr. Harriet Robinson 100x 1000x VACCINATION Pre-Clinical Therapeutic Trial Results O11_IRG / RJu9 Rlr9   0 12 50 58 66 72 112 10 7 10 5 10 3 Weeks Following Infection Infection Drug Treatment Started DNA DNA MVA Drug Treatment Interruption
  17. 17. GeoVax Vaccine Technology
  18. 18. <ul><li>Developed at Emory Vaccine Center, NIH, and CDC </li></ul><ul><li>Exclusively licensed from Emory University </li></ul><ul><li>5 issued and 6 pending patents related to AIDS vaccine components & compositions (2023) </li></ul><ul><li>29 issued or pending </li></ul><ul><li>patents in other countries </li></ul><ul><li>5 additional issued patents </li></ul><ul><li>related to AIDS vaccine </li></ul><ul><li>manufacturing process </li></ul>Strong Proprietary Technology Position O11_XTRA /
  19. 19. Rate of Vaccine Responses * Responding T cells, intracellular cytokine staining ** Anti-Env binding AB, ELISA *** After 6 intrarectal challenges with a dose 40-400 times higher than typical human dose NOTE: Polio Vaccine is 60-70% effective / Flu Vaccine 70-90% effective O11_XTRA /
  20. 20. Current Status: Therapeutic AIDS Vaccines O11_XTRA / Vaccine Sponsor Antibody (Ab to Env) T Cell Comments Bavarian Nordic MVA/BN Multiantigen NO YES Phase 1 Completed CD4 & CD8 T cells Bionor Immuno Vacc-4x Peptides NO YES Phase 2 Completed CD4 T cells but limited Response Rates Inovio PENNVAX™-B (pDNA) Unknown YES Phase 1 Active U Penn vaccine, CD4 & CD8 T cells Profectus BioSciences Multiantigen DNA + rVSV Unknown Unknown 2010 Start Planned ACTG Study GSK gp120+nef/tat fusion proteins & adjuvant YES YES Phase 1 Completed Low level neutralizing Ab, CD4 T cells Argos Therapeutics AGS-004 (RNA transfect DC) NO YES Phase 2b Active Personalized medicine approach GEOVAX DNA / MVA YES * YES * Phase 1 Enrolling * Data from GV Phase 1 trial in HIV Uninfected
  21. 21. Current Status: Preventative AIDS Vaccines Out of more than 80 vaccines entering HVTN Phase 1 testing, GeoVax Vaccines represent 2 of 6 to progress to Phase 2 O11_XTRA / Vaccine Sponsor Antibody (Ab to Env) T Cell Comments VaxGen gp 120 YES NO FAILED gp120, atypical Env Merck Ad5 NO YES FAILED Ad5 seropositive participants at higher risk NIH / VRC DNA Ad5 YES YES ENROLLING Limited to Ad5 seronegative, circumcised Not intended as commercial product Aventis ALVAC / gp120 YES LOW TRIAL COMPLETE Prevention of infection in 31% of Participants GEOVAX DNA / MVA YES YES PHASE 2a Enrollment Complete GEOVAX MVA / MVA YES YES PHASE 2a Addendum Enrollment Started December 2010
  22. 22. <ul><li>Leading Technology in Large Market Opportunity </li></ul><ul><li>Preventative and Therapeutic Applications </li></ul><ul><li>Over $50M in Non-Dilutive Government Support for Research Translation and Clinical Trials </li></ul><ul><li>Strong Intellectual Property Position </li></ul><ul><li>Significant Near-Term Clinical & Business Milestones </li></ul><ul><li>Compelling Valuation at Current Stock Price </li></ul><ul><li>Experienced Management Team with a Track Record of Success </li></ul>GeoVax -- Summary O11_IRG /
  23. 23. GeoVax Labs, Inc. Thank You!!