On July 25, 2019 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing personalized cancer immunotherapies, reported its operating and financial results for the quarter ended June 30, 2019 (Press release, Genocea Biosciences, JUL 25, 2019, View Source [SID1234537727]). Genocea has initiated Part B of its Phase 1/2a clinical trial testing the safety, immunogenicity, and efficacy of its lead neoantigen vaccine candidate GEN-009 in combination with standard-of-care checkpoint inhibitors. The company also announced plans to present additional GEN-009 immunogenicity data at this year’s meeting of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), taking place from September 27th through October 1st, 2019 in Barcelona, Spain.
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"Our presentation of GEN-009 immunogenicity data at ASCO (Free ASCO Whitepaper) 2019 marked a significant milestone for Genocea," said Chip Clark, Genocea president & CEO. "These best-in-class data showcased our unique ATLAS platform and its ability to identify each patient’s neoantigens of pre-existing T cell responses, as well as the amplification of anti-tumor cytokine responses to these neoantigens with GEN-009. These data gave us confidence to initiate Part B of our Phase 1/2a clinical trial, which we designed to demonstrate that such broad and strong anti-tumor immune responses lead to tumor shrinkage in cancer patients treated with GEN-009 and a checkpoint inhibitor."
Second Quarter 2019 Operational Highlights
Completed a public equity financing, raising $42.3 million, including the full exercise of the underwriters’ over-allotment option.
Presented best-in-class immunogenicity results for GEN-009 at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2019); the poster presentation was selected by ASCO (Free ASCO Whitepaper)’s Journal of Clinical Oncology as one of the Top 10 Featured Immuno-oncology Abstracts.
Entered into a research collaboration with Iovance exploring the use of Genocea’s ATLAS neoantigen screening platform in the development of neoantigen-targeted TIL (tumor-infiltrating lymphocyte) products.
Presented additional ATLAS data at the 2019 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2019). The poster highlighted the potential use of ATLAS as a tool to predict the advanced melanoma patients for whom checkpoint therapy might prove beneficial.
Second Quarter 2019 Financial Results
Cash position: As of June 30, 2019, cash and cash equivalents were $58.7 million versus $26.4 million as of December 31, 2018.
Research and Development (R&D) expenses: R&D expenses were $6.8 million for the quarter ended June 30, 2019, compared to $5.3 million for the same period in 2018.
General and Administrative (G&A) expenses: G&A expenses were $3.2 million for the quarter ended June 30, 2019, compared to $4.5 million for the same period in 2018.
Net loss: Net loss was $6.5 million for the quarter ended June 30, 2019, compared to a net loss of $4.4 million for the quarter ended June 30, 2018.
Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operations into the first quarter of 2021.
Conference Call
Genocea will host a conference call and webcast today at 8:30 am ET. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 7395079. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea 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 90 days.