Slide 1: Positive Viral Shedding Efficacy Results: GEN-003 Phase 2b Study
Positive Viral Shedding Efficacy Results GEN-003 Immunotherapy for Genital Herpes Phase 2b Study September 29, 2016 Exhibit 99.2
Slide 2: Safe Harbor Statement
This presentation contains “forward-looking” statements that are within the meaning of federal securities laws and are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include information concerning our possible or ass
Slide 3: Highlights
• 60 µg per protein / 50 µg of Matrix-M2 adjuvant dose hit primary clinical trial endpoint – 40% viral shedding rate reduction consistent with prior trial • Safety profile acceptable – Low discontinuation rates due to AEs; distributed across dose groups, including placebo – No grade 4 reactogenicity
Slide 4: Agenda for Today's Call
• Market potential for GEN-003 • Phase 2b trial – Study design – Top line data • Physician perspective – Lori A. Panther, MD, MPH • Important 2017 clinical and regulatory milestones • Conclusions • Q&A 4 Agenda for Today’s Call
Slide 5: The Need for New Genital Herpes Treatments Drives Large Market Opportunity
• Genital herpes characterized by viral shedding, leading to disease transmission and genital lesions • Oral antiviral therapy insufficient for millions – Viral shedding reduced only when patients are taking medication but most use episodically – Lesions still occur even on chronic therapy • GEN-003
Slide 6: Phase 2b Trial Goals and Objectives
• Overall goal – Select dose of Phase 3-ready formulation of GEN-003 for Phase 3 trials • Primary endpoint – Compare efficacy versus baseline of two dose levels of GEN-003 and placebo by impact on viral shedding • Secondary objectives – Evaluate impact on clinical disease versus placebo at 6 and 12
Slide 7: Study Design
• Randomized, double-blind, placebo-controlled • 131 subjects with a history of recurrent genital herpes • 3 dose groups, followed for 12 months – Placebo (n=44) – 60 µg per protein / 50 µg of Matrix-M2 (n=43) – 60 µg per protein / 75 µg of Matrix-M2 (n=44) • Consistent with prior trials – Inclusion
Slide 8: Statistically Significant 40% Viral Shedding Rate Reduction for 60/50 µg Dose
6% -40% -27% -50% -40% -30% -20% -10% 0% 10% Placebo 60/50 µg 60/75 µg R e d u c ti o n in V ira l S h e d d in g R a te v s. B a se lin e • In prior Phase 2, this antiviral efficacy increased to 66% at 12 months; led to significant and durable clinical efficacy at 6 & 12 months • 60 / 75 µg dose sh
Slide 9: Overall Summary of Safety
• Safety continuously reviewed by Independent Data Safety Monitoring Board • Low discontinuation rate due to AEs; similarly distributed across dose groups including placebo • Reactogenicity consistent between 2 trials for 60 µg /50 µg dose • No grade 4 reactogenicity or related SAEs in either this t
Slide 10: GEN-003 Physician Perspective
Lori A. Panther, MD, MPH Infectious Diseases specialist at Beth Israel Deaconess Medical Center and Assistant Professor of Medicine at Harvard Medical School GEN-003 Physician Perspective 10
Slide 11: Potential H2 2017 Phase 3 Start for GEN-003 On Track
11 Potential H2 2017 Phase 3 Start for GEN-003 On Track 2016 2017 6 month 6 month clinical 12 month FDA EoP2 Phase 2b Phase 2b Antiviral Combination Phase 3 Regulatory • Confirm robust efficacy with Phase 3 material • Confirm Phase 3 program • Explore potential additive effect
Slide 12: Conclusions
• Virologic efficacy profile of Phase 3-ready GEN-003 formulation confirmed for 60 / 50 µg dose ahead of Phase 3 • GEN-003 safety profile appears acceptable • 60 / 50 µg dose selected for subsequent trials – Phase 2b antiviral combination study start expected in Q4 – Potential Phase 3 start in secon
Slide 13: Questions & Answers
Questions & Answers 13
Slide 14: Contact information
Liz Bryan Spectrum Science Communications Phone: +1 202-587-2526 lbryan@spectrumscience.com Investor inquiries: Media inquiries: Jonathan Poole Chief Financial Officer Phone: +1 617-876-8191 jonathan.poole@genocea.com