Attached files
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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: