On November 2, 2017 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing neoantigen cancer vaccines, reported financial results for the third quarter of 2017 and announced upcoming data presentations at a leading immuno-oncology conference (Press release, Genocea Biosciences, NOV 2, 2017, View Source [SID1234521478]).
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“We believe our proprietary ATLASTM technology sets us apart among developers of neoantigen cancer vaccines, as it offers a potential solution to one of the most significant challenges in the field – namely, identifying true neoantigens for those vaccines from up to thousands of potential candidates,” said Chip Clark, president and chief executive officer of Genocea. “ATLAS uses a patient’s own T cells to identify, rather than predict, which of the many personal mutations found in cancerous tumors are true neoantigens, which we believe will enable us to develop more immunogenic and efficacious cancer vaccines. Our upcoming data presentations at the SITC (Free SITC Whitepaper) Annual Meeting continue to support the potential of ATLAS in neoantigen identification for personalized vaccines, including our lead program, GEN-009, for which we expect to file an IND application early next year.”
GEN-009 Progress
GEN-009 is a personalized vaccine consisting of adjuvanted synthetic long peptides of true neoantigens identified by ATLAS.
The company expects to file an Investigational New Drug (IND) application in early 2018.
Genocea plans to initiate a Phase 1 clinical trial in patients with a range of tumor types in the first half of 2018, and expects to report initial immunogenicity data in the first half of 2019.
Upcoming Scientific Presentations
Genocea announced today that it will present three posters at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting taking place November 8 to 12, 2017 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.
Poster #430 entitled “Neoantigen identification using ATLAS across multiple tumor types highlights limitations of prediction algorithms,” will be presented during the session on Personalized Vaccines and Technologies/Personalized Medicine on Saturday, November 11, 2017,
Poster #8 entitled “T cell response profiling in colorectal carcinoma patients reveals an enrichment in responses to specific tumor-associated antigens,” and
Poster #28 entitled “Profiling of T cell responses to tumor-associated antigens in lung cancer patients treated with checkpoint inhibitors,” will both be presented during the session on Biomarkers and Immune Monitoring on Saturday, November 11, 2017.
Corporate Update
Following its announced restructuring at the end of the third quarter, Genocea continues to explore, alongside its advisors, strategic alternatives for GEN-003, the company’s Phase 3-ready investigational immunotherapy to treat the large patient population infected with genital herpes, many of whom are dissatisfied with their current treatment options.
Financial Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operating expenses and capital expenditure requirements into the middle of 2018.
Third-Quarter 2017 Financial Results
Cash Position: Cash and cash equivalents as of September 30, 2017 were $22.0 million compared to $35.2 million as of June 30, 2017.
Restructuring: A corporate restructuring was implemented following the Company’s strategic shift to immuno-oncology, resulting in a charge of approximately $1.1 million for employee severance, benefits, and related costs. These amounts will be paid in the fourth quarter of 2017. In addition, Genocea incurred approximately $0.5 million of expense due to contract termination clauses that the Company anticipates will result in future cash payments and approximately $1.0 million in non-cash asset impairment charges.
Research and Development (R&D) Expenses: R&D expenses for the quarter ended September 30, 2017 increased $1.3 million, to $10.2 million from the same period in 2016. The increase was primarily driven by higher external manufacturing-related expenses and increases in compensation to support both the clinical drug supply and clinical trial planning activities in support of the previously planned GEN-003 Phase 3 program, partially offset by reduced clinical costs, due to timing of activities in support of clinical trials. Spending increases on Genocea’s immuno-oncology and cancer vaccine programs were driven primarily by increased manufacturing and compensation, consulting and professional services in anticipation of Genocea’s expected filing of an IND application for GEN-009 in the first quarter of 2018. Increased spending on these programs was offset by lower costs on infectious disease programs previously discontinued in 2016.
General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2017 were $3.8 million, compared to $3.6 million for the same period in 2016, reflecting marginal increases in consulting and professional services offset by reductions in depreciation expense, with all other expenditures across various activities remaining consistent with the same quarter in the prior year.
Net Loss: Net loss was $16.9 million for the quarter ended September 30, 2017, compared to a net loss of $12.8 million for the same period in 2016.
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 95267931. A live webcast of the conference call will be available online from the investor relations section of the Company’s website at View Source 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.