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EX-99.1 - EXHIBIT 99.1 - GENOCEA BIOSCIENCES, INC.ex991_prx7-24x2017.htm
8-K - 8-K - GENOCEA BIOSCIENCES, INC.gnca_7-24x2017x8k.htm
GEN-003 Positive Phase 2b Clinical Efficacy Results Immunotherapy Candidate for Genital Herpes 12-Month Top-line Results Exhibit 99.2


 
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 assumed future results of operations, business strategies, clinical trials and pre-clinical studies, regulatory approval of our product candidates, liquidity position and capital needs, financing plans, industry environment, potential growth opportunities, potential market opportunities and the effects of competition. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Forward- looking statements represent our management’s beliefs and assumptions only as of the date of this presentation. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. Factors that may materially affect our results of operations include, among other things, the timing of results of our ongoing and planned clinical trials, our estimates regarding the amount of funds we require to complete our clinical trials for GEN-003, our plans to commercialize GEN-003, the timing of, and ability to, obtain and maintain regulatory approval for GEN-003 and those listed in our Annual Report on Form 10-K and other filings with the Securities and Exchange Commission (“SEC”). Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. You may get copies of our Annual Report on Form 10-K, Quarterly Report on Form 10-Q and our other SEC filings for free by visiting EDGAR on the SEC website at http://www.sec.gov. 2 Disclaimer


 
• Statistically significant 49% reduction versus placebo in median genital lesion rate over 12 months for selected Phase 3 dose – Expected Phase 3 primary endpoint – Commercial-ready formulation • Positive results from other secondary clinical endpoints • No changes observed to the previously established safety profile 3 12-Month Top-Line Clinical Data Highlights


 
• Randomized, double-blind, placebo-controlled trial • 131 subjects with a history of recurrent genital herpes • 3 dose groups – Placebo (n=44) – 60 µg per antigen / 50 µg of Matrix-M adjuvant (n=43) – 60 µg per antigen / 75 µg of Matrix-M adjuvant (n=44) • Key elements consistent with prior GEN-003 trials – Inclusion / exclusion criteria, demographics, sites, dose regimen – Planned Phase 3 program shares key design elements • Clinical events collected through daily electronic patient reporting 4 Trial Design Recap


 
Wilcoxon Rank Sum test vs. placebo -49% p=0.01 -37%% reduction vs. placebo Notes: (1) Days with visible lesions divided by total days • 60/50 dose significant impact on genital lesion rate: – Reduction vs. placebo consistent with 52% reduction 6 months post dosing – Reductions vs. baseline consistent with those from prior Phase 2 5 Phase 3 Dose Significantly Reduces Genital Lesion Rate vs. Placebo over 12 Months - Expected Phase 3 Primary Endpoint Median Genital Lesion Rates(1) Post Treatment Over 12 Months After Last Dose Phase 3 Dose


 
6 Consistent, Positive Data From Secondary Clinical Endpoints at 60/50 Dose NS = p>0,05; (1) Wilcoxon Rank Sum test vs. placebo; (2) Log Rank Test; (3) Poisson mixed effect model with empirical variance


 
Phase 2 extension 24 month • Demonstrated 2-year durability of effect 7 GEN-003 Phase 3 on Track to Start by End of 2017* 2017 12 month Phase 2b Phase 3 Program FDA EoP2 Regulatory Phase 2b maintenance dosing Antiviral combination • Demonstrated clinical, virologic efficacy • Confirmed dose & commercial formulation • Phase 2b extension ongoing • Safety and benefits of GEN-003 in combination with daily antivirals • Safety and efficacy versus placebo * Subject to obtaining capital


 
• Significant efficacy at expected Phase 3 primary endpoint at Phase 3 dose, using Phase 3 formulation – ~50% fewer days with genital lesions; fewer and shorter genital lesion outbreaks; • GEN-003 Phase 3 program on track to commence in 2017* • Potential new cornerstone treatment for patients with genital herpes – Profile of durable effect on disease with convenient dosing regimen resonates with large, highly dissatisfied patient population – Potential to be first new treatment option in more than 20 years 8 GEN-003 Strongly Positioned Ahead of Phase 3 * Subject to obtaining capital


 
Q&A 9


 
Jonathan Poole Chief Financial Officer Phone: +1 617-876-8191 jonathan.poole@genocea.com Jennifer LaVin Media Relations/Corporate Communications Phone: +1 207-360-0473 jennifer.lavin@genocea.com Investor inquiries: Media inquiries: