On April 29, 2021 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported a business update for the first quarter ended March 31, 2021 (Press release, Genocea Biosciences, APR 29, 2021, View Source [SID1234578800]).
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"Genocea continues to accumulate evidence that our ATLAS platform may enable immunotherapies that preferentially attack the surface-presented antigens driving anti-tumor responses or as we say, ‘Targets Matter’," said Chip Clark, Genocea’s President and Chief Executive Officer. "Whether through our ongoing clinical trials with GEN-011, our neoantigen-targeted peripheral T cell ("NPT") therapy and GEN-009, our neoantigen vaccine, or through our research efforts with Inhibigens and SARS-CoV-2 antigen discovery, we look forward to providing updates consistent with this thesis throughout the year."
Clinical updates
GEN-011 Phase 1/2a clinical trial (the "TITAN study")
•GEN-011 is in development to treat checkpoint inhibitor-refractory patients. Genocea believes using patient T cells taken from easily accessible peripheral blood and expanding the T cells only on tumor neoantigens prioritized by our ATLAS platform may give GEN-011 efficacy, accessibility and cost advantages over other T cell therapies. The TITAN study is designed to explore safety, biomarkers of activity and anti-tumor efficacy. During the first quarter, Genocea continued to add clinical sites and accrue patients. The company expects to have initial efficacy data from a patient subset late in the fourth quarter of 2021 or the first quarter of 2022.
GEN-009 Phase 1/2a clinical trial
•The Company will provide long-term follow-up clinical and immunogenicity data from the ongoing Phase 1/2a clinical study at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") 2021 Annual Meeting from June 4 – June 8.
Research updates
Inhibigens
•At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2021 in April, the Company presented novel preclinical Inhibigen data highlighting that the presence of a single Inhibigen in an otherwise protective immunotherapy can completely reverse the therapy’s intended anti-tumor responses and the Inhibigen effect can be seen as early as 4 days post-dosing.
SARS-CoV-2
•The Company continues its SARS-CoV-2 research efforts to identify conserved antigens of protective T cell responses that may enable a next-generation vaccine protecting against a wide range of strains.
Other business updates
Strengthened executive leadership team
•Genocea appointed Jacquelyn Sumer as Chief Legal and Compliance Officer. Jackie brings over fifteen years of legal experience, including roles at several biopharmaceutical companies with a focus in oncology and cell therapy experience development and commercialization.
Financial and other updates
First quarter 2021 financial results
•Cash position: As of March 31, 2021, cash and cash equivalents were $66.0 million compared to $79.8 million as of December 31, 2020.
•Research and Development (R&D) expenses: R&D expenses were $8.8 million for the quarter ended March 31, 2021, compared to $10.0 million for the same period in 2020.
•General and Administrative (G&A) expenses: G&A expenses were $3.7 million for the quarter ended March 31, 2021, compared to $3.4 million for the same period in 2020.
•Net loss: Net loss was $12.0 million for the quarter ended March 31, 2021, compared to $12.9 million for the same period in 2020.
Debt Refinancing
•In February 2021, the Company entered into an agreement with Silicon Valley Bank for a $10 million term loan. The proceeds from the loan were used to repay the Company’s outstanding loan from Hercules Capital, Inc., and for general corporate purposes.
Guidance
•Genocea’s operating plan extends its cash runway to the end of 2022.
Conference Call
Genocea will host a conference call and webcast today at 8:30 a.m. E.T. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 2191366. 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.