Genocea Biosciences Inc · OTC:GNCAQ
Genocea Biosciences — Investor Presentation (January 2016)
26 slides from Genocea Biosciences's investor presentation, Jan 11, 2016
Slide 1: Genocea January 2016
Genocea January 2016 Exhibit 99.1
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: Creating Life-changing Medicines by Directing Effective T cell Responses
3 Creating Life-changing Medicines for Patients By Directing Effective T cell Responses ATLASTM Unique platform enabling better products through better T cell antigen selection • GEN-003: most advanced therapeutic vaccine for any chronic infection • Active discovery collaborations with leading acade
Slide 4: T cell Antigens Increasingly Matter; Genocea Uniquely Positioned to Find Them
• Infectious diseases – Genital herpes – Chlamydia – Epstein-Barr virus – Pneumococcus – Malaria – Staphylococcus – Pseudomonas – etc… • Immuno-oncology – Cancer vaccines – TCRs 4 T cell Antigens Increasingly Matter; Genocea Uniquely Positioned to Find Them ATLAS Better T cell Antigen Selection Find
Slide 5: ATLAS Enables Genocea to Identify Potentially Clinically Relevant T cell Antigens
ATLAS Enables Genocea to Identify Potentially Clinically Relevant T cell Antigens 5 RNANeon / Gritstone DNA Foundation Medicine Antigen Processing Antigen Presentation via MHC Protein Immatics / Immunocore DNA ATLAS Identifies Antigens of Optimal T cell ResponsesTools Predicting Antigens Tools Predi
Slide 6: Deep Pipeline Discovered Using ATLAS Platform
Deep Pipeline Discovered Using ATLAS Platform 6 DISCOVERY PRE-CLINICAL PHASE 1 PHASE 2 STATUS INFECTIOUS DISEASE ATLA S GEN-003 (Immunotherapy for Genital Herpes) First-in-class Landmark efficacy for immunotherapy GEN-004 (Universal Pneumococcus Vaccine) Development suspended pending data review HSV
Slide 7: Genital Herpes Immunotherapy GEN-003
Genital Herpes Immunotherapy GEN-003 7
Slide 8: First Ever Therapeutic Vaccine in Infectious Disease
• Compelling efficacy across virologic & clinical endpoints • Potential >$1bn revenue opportunity in US alone • Multiple 2016 clinical milestones – Q1: Phase 2 12 month efficacy – Q2: Phase 2b virologic efficacy – 2H: Phase 2b clinical efficacy – 2H: Combo efficacy with antivirals – 2H: End of Phase
Slide 9: Genital Herpes is a Serious, Poorly Controlled Infection
• More than 400 million infected worldwide (WHO) • Serious consequences: – Painful recurrences – High reported depression rate – 2-4 fold higher risk of HIV acquisition • Broader healthcare system costs: – ER visits for outbreaks – Elective c-sections due to fatal neonatal infection risk • Unmet nee
Slide 10: Reducing Viral Shedding Affords Path to Better Control
• Infection caused by herpes simplex viruses (HSV) • Periodic disease reactivation causes viral shedding at rates specific to individual patients • Shedding necessary for genital lesions, disease transmission 10 Reducing Viral Shedding Affords Path to Better Control Virus moves from nerve cell to sk
Slide 11: Landmark Results in Phase 1/2a Trial
11 Landmark Results in Phase 1/2a Trial • ICAAC 2013 late-breaker podium presentation for post dose 3 viral shedding results • IDSA 2014 podium presentation for full results Matrix-M2 Adjuvant gD2ΔTMR B cell Antigen • Novel T cell antigen potentially decisive for efficacy GEN-003 Designed to Direct
Slide 12: Phase 2 Trial Designed to Confirm Profile and Dose
12 Phase 2 Trial Designed to Confirm Profile and Dose Adjuvant dose 25 µg 50 µg 75 µg Protein dose 30 µg 60 µg Placebo* Goals & Objectives Trial Design • Explore and justify protein and adjuvant dose for Phase 3 • 1o – Confirm best dose by impact on viral shedding rate • 2o – Compare i
Slide 13: Sustained Reduction in Viral Shedding Rate Through 6 Months
-100% -50% 0% Baseline Post dose 3 6 Months C ha ng e v s. b a se lin e 30/25 µg 30/50 µg 30/75 µg 60/25 µg 60/50 µg 60/75 µg Placebo 13 Sustained Reduction in Viral Shedding Rate Through 6 Months • Stronger response at 6 months than in Ph 1/2 – 58% vs. 40% • Upside potential for durable effect to 1
Slide 14: Compelling Efficacy at 6 Months Post Dosing on Potential Phase 3 Endpoints
14 Compelling Efficacy at 6 Months Post Dosing on Potential Phase 3 Endpoints Median Time to First Outbreak Note: Placebo patients unblinded after post-dose 3 28-day observation period. Day 28 Unblinding Note: Placebo patients rolled to active drug after unblinding Day 182.5 Days after Last GEN-003
Slide 15: Efficacy Seen Across Additional Clinical Endpoint
-100% -50% 0% Baseline Post dose 3 6 Months C ha ng e v s. b a se lin e 30/25 µg 30/50 µg 30/75 µg 60/25 µg 60/50 µg 60/75 µg Placebo 15 Efficacy Seen Across Additional Clinical Endpoint Genital Lesion Rate Reduction vs. Baseline * Poisson model analysis vs. baseline *** p<0.0001, * p<0.05 Protein d
Slide 16: Durability Reinforces GEN-003 Value Proposition
16 6 Months Durability Reinforces GEN-003 Value Proposition Potential cornerstone treatment for genital herpes with >$1bn GNCA revenue opportunity in US alone Potential Advantages Over Oral Anti-Virals >$1bn vs. chronic suppression (~1/3 treated patients) • Durable efficacy via novel mechanism • Ora
Slide 17: Milestone Rich 2016 Enables 2017 Phase 3 Start
17 Milestone Rich 2016 Enables 2017 Phase 3 Start 2016 2017 Q1: 12 month Q2: Post Dose 3 6 month 12 month 6 month 12 month FDA EoP2 Post Dose 3 Phase 2 Dose Optimization Phase 2b Phase 2b Antiviral Combination Phase 3 Regulatory • Upside if durable to 12 months • Booster timing • Confirm robust effi
Slide 18: ATLAS: Enabling New Immuno-oncology Therapies
ATLAS: Enabling New Immuno-oncology Therapies 18
Slide 19: Partnering with World Leaders to Expand T cell Cancer Antigen Discovery Efforts
19 Partnering with World Leaders to Expand T cell Cancer Antigen Discovery Efforts Center Collaborators Disease Antigens Dana-Farber Cancer Institute Stephen Hodi, MD Melanoma Tumor- associated antigens Memorial Sloan Kettering Cancer Center Tim Chan, MD, PhD Jedd Wolchok, MD, PhD Melanoma NSCLC Neo
Slide 20: Epstein-Barr Virus Immunotherapy Program Underway
• Therapeutic potential against cancers with unmet needs: – Post-transplant lymphoproliferative disease – Non-Hodgkin’s lymphoma – Nasopharyngeal carcinoma – Gastric carcinoma • Highly suited to ATLAS – T cells responses are crucial to protection – A large virus, making antigen prediction extremely
Slide 21: Genocea Value Proposition
Genocea Value Proposition 21
Slide 22: Corporate Summary
Corporate Summary Phase 2b asset with efficacy confirmed and multiple 2016 milestones • Compelling efficacy profile and dose confirmed • Efficacy seen consistently across potential Phase 3 endpoints • Potential >$1bn revenue opportunity in US alone • 2016 milestones: – Q1: Phase 2 12 month efficacy
Slide 23: Genocea Biosciences, Inc. contact details
Genocea Biosciences, Inc. NASDAQ: GNCA Cambridge Discovery Park 100 Acorn Park Drive 5th floor Cambridge, MA 02140 USA Phone: +1 617.876.8191 www.genocea.com 23
Slide 24: Capital Strength and Structure
• Cash at Q3 2015 – $112.5m • Funded into H2 2017 • Additional capital flexibility – $50m ATM facility filed (no sales to date) – Debt facility - $17.0m drawn, further $10.0m available – Business development • Shares outstanding (11/3/15) – Basic – 28.1m – Fully diluted – 31.1m 24 Capital Strength a
Slide 25: GEN-003-001 Data Tables
25 GEN-003-001 Data Tables Viral Shedding Rate Baseline Treatment Group Rate # of Subjects Rate Change from Baseline # of Subjects Rate Change from Baseline # of Subjects Rate Change from Baseline Placebo 12.4 26 12.8 3% 23 16.6 34% 13 12.3 -1% Proteins only 7.4 26 10.0 35% 22 8.6 16% 15 14.4 95% GE
Slide 26: Viral Shedding and Genital Lesion Rate Data Tables
Viral Shedding Rate Baseline Treatment Group Rate # of Subjects Rate Change from Baseline # of Subjects Rate Change from Baseline # of Subjects Rate Change from Baseline Placebo 23.2 44 22.2 -4% NA NA NA NA NA NA 30 µg / 25µg 13.6 43 11.3 -17% 38 11.8 -13% 30 µg / 50µg 17.5 40 10.8 -38% 38 8.7 -50%
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