On August 9, 2017 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing novel vaccines and immunotherapies targeting T cell antigens, reported financial results for the second quarter of 2017 (Press release, Genocea Biosciences, AUG 9, 2017, View Source [SID1234520117]). Genocea is developing GEN-003, an investigational immunotherapy for the treatment of genital herpes, and is applying its unique and proprietary T cell antigen identification platform, ATLAS, to immuno-oncology and cancer vaccine development. Schedule your 30 min Free 1stOncology Demo! Highlights of the Second Quarter of 2017 and Recent Events
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May 2017 – In its first quarter earnings report, Genocea announced (i) the successful completion of its end-of-Phase 2 meeting for GEN-003 with the U.S. Food & Drug Administration and (ii) data from its prior GEN-003 Phase 2 trial indicating that the initial course of injections sustained clinical and virologic efficacy for at least 24 months.
June 2017 – Genocea announced its addition to the Russell 3000 and Russell 2000 Indices as part of the annual reconstitution of those indexes.
July 2017 – Genocea reported positive top-line 12-month Phase 2b data for GEN-003 including statistically significant data on the expected Phase 3 primary endpoint with the Phase 3 dose, and positive results on multiple secondary clinical endpoints.
Chip Clark, president and chief executive officer of Genocea, commented: "We are delighted with the recent positive GEN-003 12-month Phase 2b data and continue to explore means of securing capital for this program to enable the start of Phase 3. We believe that, if approved, GEN-003 could become the first new therapy to treat genital herpes in more than 20 years and address serious unmet patient needs.
"With respect to our cancer vaccine program, recent scientific publications on neoantigen cancer vaccines suggest that the concept has promise, but we think that there is significant room for improvement. We believe that Genocea’s ATLAS platform can enable better neoantigen selection and that, combined with our vaccinology expertise, positions us strongly in this emerging field. We expect to file an IND by the end of 2017 for our neoantigen vaccine, GEN-009, and we are also continuing our pre-clinical work on common antigen cancer vaccines and an EBV-related cancer vaccine."
Financial Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operating expenses and capital expenditure requirements into 2018. Genocea is currently exploring various avenues to secure capital to advance GEN-003 into Phase 3 trials and does not intend to commence Phase 3 development of GEN-003 until it has secured such capital.
Second-Quarter 2017 Financial Results
Cash Position: Cash and cash equivalents as of June 30, 2017 were $35.2 million compared to cash, cash equivalents and investments of $48.7 million as of March 31, 2017.
Research and Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2017 increased $4.7 million, to $11.4 million, from the same period in 2016. The increase was primarily driven by higher external manufacturing-related expenses and increases in compensation, consulting and professional services to support both the clinical drug supply and clinical planning activities in support of GEN-003 Phase 3 program readiness. 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 Investigational New Drug (IND) application for GEN-009 in 2017. Increased spending on these programs was offset by lower costs on deprioritized infectious disease programs.
General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2017 were $3.6 million, compared to $4.0 million for the same period in 2016 reflecting lower depreciation costs and lower consulting and professional services costs.
Net Loss: Net loss was $15.4 million for the quarter ended June 30, 2017, compared to a net loss of $11.0 million for the same period in 2016.