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1 EBOLA HIV January 2015
2 Comments made today contain forward looking statements as described under the Private Securities Litigation Reform Act of 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 obtain needed funding, that the products we have under development may not prove successful, and other risks including those set forth under risk factors in our Form 10-K and our other SEC filings. 2
3 HIV and Ebola Vaccines Unique MVA-expressed Virus-Like Particles (VLP) Platform Durable humoral (antibody) and cellular (T cell) responses Proven clinical safety in normal and HIV-infected individuals Ebola Epidemic (single-strain) and routine vaccines (3-strain) in development Rapidly moving program, Phase 1 trials planned Q HIV Preventive and therapeutic Most advanced preventive vaccine for developed world (clade B) Tested through Phase 2a (500 participants) with NIH funding Therapeutic cure program OTCQB: GOVX 3
4 Program Preclinical Phase 1 Phase 2 Phase 3 Status Ebola Epidemic Vaccine (Zaire strain) Routine Vaccine (3 strains) Constructs under development Constructs under development HIV Clade B (developed world) Preventive Vaccine Immunotherapy Phase 2a completed NIH/HVTN planning next trial Phase 1b planning ( Shock trial) HIV Clade C (developing world) Preventive Vaccine Immunotherapy Pending NIH grant support Pending NIH grant support 4
5 Expression of Virus-Like Particles from Vaccinated Cells: Display the Native Form of the Virus Surface Protein (Glycoprotein) to the Immune System Trains the Immune System to Recognize and Kill Actual Virus Demonstrated Ability to Elicit High-Quality Antibody (tightly binding) Two roles of Antibody Neutralizing antibody that block virus infection Binding antibody that tag virus or infected cells for killing by macrophages, neutrophils, natural killer cells, or complement VLP budding from vaccine-expressing cells Protective Antibodies binding to Env 5
6 Recombinant Modified Vaccinia Ankara (MVA) vectors expressing Virus-Like Particles (VLPs) in human cells 6 Ebola VLPs HIV VLPs
7 Ebola Vaccine Program
8 8
9 # of outbreaks 28 Outbreaks Since Outbreak 20,712 cases, 8,219 deaths (39% fatal) Year 9
10 GOVX-E301 Rapid regimen for epidemic response (Zaire strain) GOVX-E302 Spaced regimen for routine immunization (3 strains) Advantages of GeoVax MVA Platform Safety Vector safety demonstrated in HIV clinical trials Immunogenicity Virus-like particles raise robust immune responses Durability Highly durable antibody responses in HIV trials Limited Pre-existing Immunity MVA vector based on smallpox virus Market Market size unknown but large for a small biotech Epidemic response (WHO estimates 10-27M doses) Stockpiling future outbreaks Stockpiling biodefense 10
11 Development Status Vaccine constructs under development VLP expression demonstrated in human cells Small animal immunogenicity studies Q Primate challenge studies planned for late 2015 Vaccine production to begin in 2015 Clinical trials planned for
12 HIV Vaccine Program
13 HIV/AIDS, the 5 th leading cause of death globally 34M people currently living with HIV (4M Clade B) 2.3M new infections reported annually (190K Clade B) North America 1.4M 51,000 NEW CLADE B Caribbean 240,000 20,000 NEW Western / Central Europe 900,000 30,000 NEW Middle East / North Africa 300,000 37,000 NEW Eastern Europe / Central Asia 1.4M 140,000 NEW East Asia 830,000 89,000 NEW South / Southeast Asia 4.0M 280,000 NEW Latin America 1.4 M 83,000 NEW Sub-Saharan 23.5M 1.8M NEW CLADE C / OTHER Oceania 53,000 2,900 NEW 13
14 100% >1.1 million HIV-infected individuals in the US 82% HIV-diagnosed 66% Linked to HIV care 37% Retained in HIV care 33% Prescribed ART Source: HI Hall et al. JAMA Intern Med 173:1337, % Successful control of only 1 in 4 infections
15 U.S. Financial Burden Est. lifetime medical costs for an HIV-infected person $500,000 Annual U.S. taxpayer cost of HIV care and treatment* $16 billion Estimated annual loss of productivity $30 billion *Medicaid, Medicare, Ryan White Act U.S. HIV Infection Rate Total current infections 1.1 million Annual new infections (~140 per day) 50,000 Annual infection rate has remained unchanged for 20 years 15
16 Focusing on clade B HIV Phase 1 and Phase 2a clinical trials completed Clinical trials fully funded by NIH Conducted by HIV Vaccine Trials Network (HVTN) Out of over 100 Phase 1 trials conducted by HVTN, only 5 concepts progressed to Phase 2 including GeoVax Planning next stage of clinical trials with NIH/HVTN Worldwide market potential = $4 billion 16
17 Percent uninfected Vaccinated with SIV prototype, rested 6 months Given 12 weekly rectal challenges with a dose 50 times higher than most frequent human exposure 100 MMM control n= n= Number of challenges 40% of vaccinated animals remained uninfected after 9 challenges 17
18 Immunogenicity observations (as compared to *RV144 Thai Trial) GeoVax HVTN 205 Phase 2a MVA/MVA Sanofi-Aventis RV144 Phase 3 ALVAC/ ALVAC+AIDSVAX Anti-Env Binding Antibody 98% 99% Antibody Durability (6 mo) <3x Decline 10x Decline Neutralizing Antibody Tier 1 (clades A,B,C) Tier 2A (3/3 tested) Tier 1 (Clades A,B,C) Tier 2A (not detected) Helper T Cell (CD4+) 66% Response Rate 30% Cytotoxic T Cell (CD8+) 22% Response Rate 0% Protection TBD 31.2% 18 *RV144 is the only trial to have achieved some protection
19 Clinical Pathway in Addition to Our Preventive HIV Vaccine Problem Oral drugs (ART) control HIV, but do not eliminate it HIV persists in latent form and can re-emerge Shock & Kill Approach for Cure Shock agent activates latent viral reservoir Kill agent recognizes and destroys activated cells GeoVax Clinical Plans Test DNA as Shock agent in presence of ART Phase 1b trial in planning initiation (subject to funding) Develop killing agents for follow-on trials Antibody-mediated killing Unconventional CD8 T cells 19
20 20 Corporate Profile
21 Management: Robert T. McNally, Ph.D. President/CEO Harriet L. Robinson, Ph.D. Chief Scientific Officer Mark W. Reynolds, CPA Chief Financial Officer Board of Directors: David A. Dodd Chairman Robert T. McNally, Ph.D. President/CEO Harriet L. Robinson, Ph.D. Chief Scientific Officer Dean G. Kollintzas Independent Director John N. Spencer, Jr. Independent Director Shareholders Board & Management 7.6% Emory University 14.5% All Other (all < 5%) 77.9% 21
22 Cash Balances $1.2M Annual Core Burn Rate $2-3M Financing History Equity $23.1M NIH research grants 44.0M NIH clinical trial support (thru Phase 2a) 10.0M No Debt Shares Outstanding Primary 32M Fully Diluted 38M 22
23 Ebola & HIV High profile government-supported programs Short-term path to Ebola proof-of-concept HIV proven in non-human primates Preventive HIV program on auto-pilot Minimal financial needs for clinical trials (funded by NIH) Expanding product pipeline with MVA platform Proprietary vaccine technology developed at Emory/NIH/CDC Most clinically advanced vaccine candidate for prevention of HIV infection in the developed world (US, Western Europe) Scientific rationale for HIV efficacy success 23
24 24
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