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GENOCEA BIOSCIENCES: Genocea Reports Third Quarter 2015 Financial Results

The following excerpt is from the company's SEC filing.

- Company Reports Recent Milestones and Announces Expansion of ATLAS

Technology into Immuno-Oncology -

- Conference Call and Webcast Scheduled for 9:00 a.m. ET Today -

- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today reported recent corporate highlights and financial results for the third quarter ended September 30, 2015.

“In early October, we reported positive six-month durability data for GEN-003 which further support its potential to serve as a cornerstone the rapy for genital herpes infections with convenient, long-term disease control. We look forward to reporting 12-month data from this ongoing trial in the first quarter of 2016 and to our end of Phase 2 meeting with the FDA later next year,” said Chip Clark, president and chief executive officer of Genocea. “Additionally, we are excited to report several recent milestones as part of the expansion of our ATLAS technology into oncology, following encouraging data from our ongoing collaboration with the Dana-Farber Cancer Institute. Having demonstrated its power in infectious disease, we believe that ATLAS is positioned to enable smarter identification of cancer vaccine antigens and smarter immuno-oncology response profiling to optimize patient care.”

Business Highlights and Anticipated Milestones

GEN-003 - Immunotherapy for treatment of genital herpes in Phase 2 development. Greater than $1 billion potential revenue opportunity in the U.S.

Reported positive results six months after dosing from ongoing Phase 2 dose optimization trial

12-month data expected in the first quarter of 2016

End of Phase 2 meeting with U.S. Food and Drug Administration expected in late 2016

On October 7, 2015, Genocea reported positive results from a planned interim analysis of data collected six months after dosing from its ongoing Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. At its best performing dose of 60 µg per protein / 75 µg of Matrix-M2

adjuvant, GEN-003 demonstrated a statistically significant 58 percent reduction from baseline in the viral shedding rate (p<0.0001), the primary endpoint of the study and a measure of anti-viral activity.

In a planned secondary analysis to assess the impact on genital lesion rates, GEN-003 demonstrated sustained and statistically significant reductions from baseline in five of six dose groups ranging from 43 to 69 percent. In addition, the proportion of patients receiving GEN-003 who were lesion-free at six months after dosing ranged from approximately 30 to 50 percent, similar to results reported in Phase 3 clinical trials with oral antiviral therapies. A further secondary analysis measuring the time to first recurrence after completion of dosing showed a range of 152 days to greater than 180 days among dose groups. The Phase 2 trial continues to show that GEN-003 is safe and well tolerated by patients, with no serious adverse events related to the vaccine.

GEN-004 - Vaccine for the prevention of infections by all serotypes of pneumococcus.

Reported top-line results from Phase 2a clinical trial in October

Development suspended pending review of potential paths forward

On October 19, 2015, Genocea reported that top-line results from a Phase 2a clinical trial for GEN-004 showed consistent reductions versus placebo in the pre-specified endpoints of the rate and density of colonization, but

neither of the endpoints achieved statistical significance. GEN-004 was safe and well tolerated by patients. Genocea has suspended development in GEN-004 pending further review of the data and expert consultation.

ATLAS technology platform - Expansion into immuno-oncology

Results from Dana-Farber collaboration to be presented at SITC on November 6; collaboration ongoing

New collaboration with Memorial Sloan Kettering Cancer Center announced today

ATLAS’s ability to identify T cell antigens may unlock new cancer vaccines

Immunotherapy program initiated targeting Epstein-Barr Virus

Genocea was founded to create T cell-directed immunotherapies and vaccines using ATLAS, a unique platform for profiling large and diverse patient populations to find the T cell antigens driving protective responses. The Company believes that data reported to date for GEN-003 represents the first evidence of efficacy by an immunotherapy built around new T cell targets for an infectious disease. Building on the success of ATLAS in genital herpes, Genocea initiated a research collaboration with Dana-Farber in 2014 to apply ATLAS in immuno-oncology. This collaboration centered on the potential of ATLAS to identify patterns of T cell response in cancer patients receiving checkpoint inhibitor therapy.

ATLAS makes no assumptions about which cancer antigens are meaningful and which are not. It instead takes a panoramic view of a large, diverse population of human subjects and reveals clinically relevant T cell antigens of protective responses. In contrast to other high-throughput predictive tools currently being applied in oncology drug discovery, Genocea believes that ATLAS

has...


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