GeoVax Labs, Inc. · NASDAQ:GOVX
GeoVax Labs — Investor Presentation (February 2010)
35 slides from GeoVax Labs's investor presentation, Feb 9, 2010
Slide 1: GeoVax Labs, Inc. – Company Overview
GeoVax Labs, Inc. – Company Overview OTCBB GOVX OTCBB: R b tT Robert T. M McNally, N ll PhPh.D., D P President id t & CEO Mark W. Reynolds, CPA, CFO 09 February 2010
Slide 2: Disclaimer
Disclaimer Comments made today contain forward looking statements as described under the Private Securities Litigation Reform Act of 1995. Our forward looking statements represent our current view and are subject to risks and uncertainties. These risks include the risk that we may not be able to obt
Slide 3: Developing Vaccines To Combat HIV / AIDS
(OTCBB: GOVX) Developing Vaccines To Combat HIV / AIDS
Slide 4: GeoVax Company Summary
GeoVax Company Summary • Preventative & Therapeutic HIV/AIDS Vaccines • Excellent Safety & Immune Response Data for Preventative Use • Preventative Vaccine Trial – Phase 2a Enrollment Proceeding • Therapeutic Th ti V Vaccine i T Trial i l – Phase Ph 1 tto St Startt Early 2010 • Strong Government Sup
Slide 5: Preventative Vaccine
Preventative Vaccine • Designed to Vaccinate HIV Uninfected People - Protect individuals from developing AIDS - Reduce transmission, protecting population at large - Potential universal vaccine with g global need 5
Slide 6: Therapeutic Vaccine
Therapeutic Vaccine • Designed to Treat HIV Infected People - Protect individuals from progressing to AIDS - Supplant need for oral medication reducing medication, cost and drug related side effects - Projected Phase 1 start early 2010 start, 6
Slide 7: Proprietary Technology
Proprietary Technology • Developed at Emory Vaccine Center, NIH, and CDC • Exclusively licensed from Emory University • 14 issued or pending patents related to various components and compositions of AIDS vaccines • Additional five issued patents t t coveringi the AIDS vaccine manufacturing process 7
Slide 8: Two GeoVax Vaccine Regimens
Two GeoVax Vaccine Regimens 1. DNA & MVA - Recombinant DNA Vaccine • Primes immune response - Recombinant MVA Vaccine • Boosts immune response 2. MVA Only - Recombinant MVA Vaccine • Primes & Boosts immune response 8
Slide 9: GeoVax DNA and MVA Vaccines
GeoVax DNA and MVA Vaccines • Both Vaccines Express Non-infectious Virus-like Particles • Both Designed to Elicit Protective Ab (antibodies) and T cells (type of white blood cells) DNA Prime MVA Boost 9
Slide 10: Two Protective Immune Responses
Two Protective Immune Responses 1. Vaccine Elicited Anti-HIV-1 Antibodies - Recognize & Tag HIV HIV-1 1 virus & HIV-1 HIV 1 infected cells for destruction 2 Vaccine Elicited Anti 2. Anti-HIV-1 HIV 1 T cells - Recognize & Kill HIV-1 infected cells Photographs courtesy of The Scripps Research Institut
Slide 11: GeoVax Vaccines Elicit Ab to “Native” Env
GeoVax Vaccines Elicit Ab to “Native” Env Protein Surrounding HIV Virus Other Vaccines in Phase 2/3 Trials GeoVax GeoVax Aventis NIH VRC VaxGen DNA MVA ALVAC Ad5 Viral or Cell Membrane HIV gp160 gp150 gp160Δecto gp140ΔCFI gp120 trimer trimer gp41 trimer 11
Slide 12: Avidity of Anti-Env Ab for “Native” Env
Avidity of Anti-Env Ab for “Native” Env Correlates with Protection GeoVax Vaccine GeoVax Vaccine SHIV 162P3 Challenge r = -0.9, p < 0.001 108 Peak viral RNA 107 106 105 10 20 30 40 50 60 70 gp160 gp140 gp120 trimer trimer Avidity Index Avidity Indicies Do Not Correlate 12
Slide 13: Preclinical Protection
Preclinical Protection Fold Reduction Challenge Challenge in Median Viral RNA Virus Model GeoVax Merck SHIV 89.6P Easy to Protect > 1000x > 1000x SIV 251 Difficult to Protect 5 to 50x 0x Unpublished Data from Study Conducted by Dr. R. Amara at Emory University 13
Slide 14: Conduct of Human Preventative Trials
Conduct of Human Preventative Trials • Preventative trials conducted by NIH sponsored HIV Vaccine Trials Network • Immunogenicity assays conducted by HVTN Laboratories • Safety assessed byy HVTN Clinics 14
Slide 15: Phase 1 Safety Data
Phase 1 Safety Data • Local Reactions: Pain,, Tenderness,, Redness of the Injection j Site - No severe reactions - Majority with transient mild reactions • Systemic S t i Reactions: R ti Malaise, Myalgia, Headache, Nausea - No difference from p placebo 15
Slide 16: Rate Of Vaccine Responses
Rate Of Vaccine Responses GeoVax – Phase 1 Merck – Phase 2b DNA/MVA MVA only Ad5 <18 Ad5 >18 n = 30 n = 30 n = 52 n = 64 CD4 * 77% 43% 44% 36% CD8 * 42% 17% 90% 59% anti-Env anti Env 82% 86% 0% 0% Ab ** * Responding T cells, intracellular cytokine staining ** Anti-Env A ti E binding bi di Ab, Ab ELI
Slide 17: Why the World Needs an AIDS Vaccine
Why the World Needs an AIDS Vaccine • Current prevention efforts are not sufficient to turn the tide of the pandemic • Vaccines are historicallyy the best tool for fighting infectious disease, e.g.g smallpox, p p polio, measles • Vaccine Objectives - Prevent disease - Reduce transmission 17
Slide 18: Preventative Need for Vaccine
Preventative Need for Vaccine New infections in 2008 2.7 Million Eastern Europe/ Western/Central Central Asia Europe North America 110 000 110,000 East Asia 30,000 55,000 75,000 Middle East / Caribbean North Africa South/Southeast Asia 20,000 35,000 280,000 Latin America Sub-Saharan Africa Oceania 1
Slide 19: Therapeutic Need for Vaccine
Therapeutic Need for Vaccine People living with AIDS in 2008 33.4 Million Eastern Europe/ Western/Central Central Asia Europe North America 1 5 Million 1.5 East Asia 850,000 1.4 Million 850,000 Middle East / Caribbean North Africa South/Southeast Asia 240,000 310,000 3.8 Million Latin America Sub-Sa
Slide 20: First GeoVax Vaccine: Clade B for Developed World
First GeoVax Vaccine: Clade B for Developed World B B C B C C B B B C B, C, BC CRF01 B CRF01, C A NO DATA B, BF AG F,G,H,J,K A, B, AB D SOURCE: IAVI Report, IAVI (May/June 2002) 20
Slide 21: Impact of a Preventative Vaccine
Impact of a Preventative Vaccine A 50% effective vaccine given to just 30% of the population could cut the number of new HIV infections in the developing world by more than half over 15 years. years Total New Infections Averted by an AIDS Vaccine YEARS SOURCE: AIDS Vaccine Blueprint 2006, IAVI Repor
Slide 22: Preventative Vaccine Market
Preventative Vaccine Market Total Annual Global Revenue Projections for a Range of 1st Generation AIDS Vaccines 6 SCENARIO Peak Avg. g Annual Cumulative Global Sales Revenue Sales Revenue Revenue (over years over 30 year enue (Billions of US$) 5 0-30) period HIGH $5.49 $5 9B $4.34 B $ $134.37 B $ 4
Slide 23: Preventative Clinical Trials
Preventative Clinical Trials CLADE PRE CLINICAL PHASE 1 PHASE 2 PHASE 3 B DNA/MVA PLANNING B MVA only PLANNING C A+ B + C B Adjuvants PLANNING 23
Slide 24: Preventative Phase 2a Human Trial
Preventative Phase 2a Human Trial HVTN 205 FULL DOSE Month 0 2 4 6 9 12 DNA MVA • Two Doses of DNA and MVA to Build Safety Data • 150 Vaccine Recipients and 75 Placebos • 13 Trial Sites in North and South America 24
Slide 25: Current Status of Preventative AIDS Vaccines
Current Status of Preventative AIDS Vaccines Out of more than 80 entering HVTN Phase 1 testing, only 5 progressed to Phase 2 Vaccine Antibody T Cell Comments Sponsor (Ab or Env) VaxGen FAILED YES NO gp120 gp120, 120 atypical t i lE Env FAILED Merck NO YES Ad5 seropositive participants Ad5 at higher
Slide 26: GeoVax Compared to Aventis
GeoVax Compared to Aventis GeoVax DNA GeoVax MVA Aventis ALVAC VaxGen Natural Mutation Vi l or C Viral Cellll F Form off Env E 41 Monimer gp41 M i Membrane gp160 trimer gp150 trimer gp160Δecto gp41 gp160Δecto, gp120 gp Smallpox Vector Alvac Sanofi-Aventis Canary Pox Vector Prime/Boost Prime/Boost Ge
Slide 27: GeoVax versus Aventis Vaccine
GeoVax versus Aventis Vaccine • Broader, Higher T cell Response Rates • Protection in Higher Percentage of Participants Expected p with GV Vaccine • Better Quality Ab 27
Slide 28: Therapeutic Vaccine Market
Therapeutic Vaccine Market • Global Need • Current C tTTreatment t t Cost C t High Hi h - $1,500 per month - $18,000 $ per year • Current Treatment NOT a Viable Long Term Solution • Value Unknown = $ Billions 28
Slide 29: Therapeutic Clinical Trials
Therapeutic Clinical Trials PRE CLINICAL PHASE 1 PHASE 2 PHASE 3 Adult * PLANNING AWAITING FDA APPROVAL Adolescent Adjuvants PLANNING * Scheduled to begin Early 2010 29
Slide 30: Preclinical Therapeutic Trial Results
Preclinical Therapeutic Trial Results Treatment Treatment Infection Started Interruption RJu9 DNA DNA MVA Rlr9 107 sma pies/mL Plas 105 al RNA, Cop 100x Reduction 1000x Reduction Vira 103 0 12 50 58 66 72 112 Weeks Following Infection Unpublished Data: Dr. R. Amara and Dr. H. Robinson 30
Slide 31: Product Advantages
Product Advantages • Antibody and T Cell Responses - Protects by y tagging gg g native Env • Low Cost Vaccine Manufacturing Processes • Promising Preventative Phase 1 Trial Results - Safety and immune response • Exclusive E l i Li License tto T Technology h l - Emory University, NIH, and CDC 31
Slide 32: GeoVax Support
GeoVax Support NIH (DAIDS) R&D Funding (IPCAVD Grant) HIV Vaccine Emory Trials Network University (HVTN) Vaccine Center Yerkes Primate Clinical Trials Center GeoVax Regulatory Vaccine Consultants Manufacturers 32
Slide 33: Financial Summary
Financial Summary • Sources of Funding - Current Cash on Hand = 3.5M (12/31/2009) ( ) - NIH IPCAVD Grant (2007) = $18M / 5 year - HVTN Clinical Trial Support - Stock Purchase Agreement • Modest M d tC Cash hBBurn R Rate t • Seeking Grant/Foundation Support for Product Expansion Program Incorporating
Slide 34: Capital Structure
Capital Structure • Stock Exchange: OTCBB: GOVX • Market Cap: $110 Million (01/31/10) • 52 Week Range: $0.09 - $0.38 • Ownership: BOD/Officers 17.1% Others 53.3% Emory University 29.6% 34
Slide 35: 1900 Lake Park Drive, Smyrna, Georgia
1900 Lake Park Drive Drive, Suite 380 Smyrna, Georgia 30080 USA ((678)) 384-7220 tel (678) 384-7281 fax investor@geovax.com OTCBB: GOVX