Genocea Biosciences Inc (NASDAQ:GNCA) Files An 8-K Reports Third Quarter 2016 Financial Results

The Company presented immunogenicity data from its previous Phase 2 trial at IDWeek 2016, the premier annual meeting for healthcare professionals focusing on infectious diseases. These data show that GEN-003 induced antigen-specific polyfunctional T cell responses in immunized subjects, a hallmark of potent T cell immunity. These data also demonstrated that GEN-003 elicited increases in IgG and neutralizing antibody levels above baseline that persisted for one year after the last dose, consistent with viral shedding and clinical symptom reduction seen at 12 months.

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Anticipated Milestones and Events

GEN-003

Phase 2b 6-month placebo-controlled clinical efficacy data expected in January 2017
End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) expected in 1Q 2017
Antiviral combination study now planned as part of GEN-003 Phase 3 program

Immuno-oncology collaborations and cancer vaccine strategy

Data showing ATLAS’s differentiated neoantigen selection capabilities from the ongoing partnership with Memorial Sloan Kettering Cancer Center to be presented at the Society for Immunotherapy of Cancer’s (SITC) 31st Annual Meeting & Associated Programs in National Harbor, Maryland. The poster, #374, entitled Genome-scale neoantigen screening using ATLAS™ prioritizes candidates for immunotherapy in a non-small cell lung cancer patient will be presented on Saturday November 12, between 11:45 am and 1:00 pm and 6:45 pm and 8 pm ET
Immuno-oncology strategy and neoantigen cancer vaccine development plan update expected at R&D Day in December

Upcoming Events & Presentations

Neoantigen Summit 2016, Boston, November 15
Stifel 2016 Healthcare Conference, New York City, November 16
Piper Jaffray 28th Annual Health Care Conference, New York City, November 30
Virtual R&D Day, week of December 12

Updated Financial Guidance:

Genocea now expects that its existing cash, cash equivalents and marketable securities are sufficient to support its operating expenses and capital expenditure requirements into the first quarter of 2018, without assuming any receipt of proceeds from potential business development partnerships, equity financings or debt drawdowns. This guidance is made on the basis of Genocea’s current operating plans, which include focusing its research activities on immuno-oncology, conducting the antiviral combination study as part of the GEN-003 Phase 3 program and initiating Phase 3 trials for GEN-003 in the second half of 2017.

Third Quarter 2016 Financial Results

Cash Position: Cash, cash equivalents and investments as of September 30, 2016 were $75.5 million compared to $86.0 million as of June 30, 2016.

Research and Development (R&D) Expenses: R&D expenses for the quarter ended September 30, 2016 increased $2.8 million, to $8.8 million, from the same period in 2015. The increase was driven by increases in headcount and related expenses to support the GEN-003 program and higher clinical costs for the ongoing and anticipated GEN-003 trials. Higher personnel and lab-related costs to advance Genocea’s pre-clinical product candidates and develop the ATLAS platform for immuno-oncology also contributed to the increase. These higher R&D costs were partially offset by lower GEN-004 costs due to the Phase 2a trial which was ongoing in the third quarter of 2015 and has since been completed.

General and Administrative (G&A) Expenses: G&A expenses for the quarter ended September 30, 2016 were unchanged at approximately $3.6 million from the same three-month period in 2015.

Net Loss: Net loss was $12.8 million for the third quarter ended September 30, 2016, compared to a net loss of $9.8 million for the same period in 2015.

Conference Call

Genocea will host a conference call and webcast today at 9:00 a.m. ET. The conference call may be accessed by dialing (844) 826-0619 for domestic participants and (315) 625-6883 for international callers and referencing the conference ID number 96207224. A live webcast of the conference call will be available online from the investor relations section of the company’s website at http://ir.genocea.com. A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event, and will be archived for 30 days.

About Genocea Biosciences, Inc.

Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immunity. Using ATLASTM, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea’s pipeline includes GEN-003, a novel T cell-enabled immunotherapy for genital herpes in Phase 2 clinical development, and earlier-stage investments in immuno-oncology. For more information, please visit the company’s website at www.genocea.com.

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