EMERYVILLE, Calif. - Gritstone bio, Inc. (NASDAQ:GRTS), a clinical-stage biotechnology company, announced today that its Phase 2b trial for a next-generation COVID-19 vaccine is now slated to commence in Fall 2024, a change from the originally planned first quarter of the year. The decision to reschedule the trial aims to incorporate fully Good Manufacturing Practice (GMP)-grade raw materials, which is anticipated to enhance the study's regulatory value.
The upcoming CORAL-BARDA study, supported by federal funds from the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA), is a randomized, double-blinded trial set to enroll 10,000 participants. It will compare the efficacy, safety, and immunogenicity of Gritstone's self-amplifying mRNA (samRNA) vaccine candidate against an approved COVID-19 vaccine.
Andrew Allen, MD, PhD, Co-founder, President & CEO of Gritstone bio, expressed gratitude to the FDA and BARDA for their guidance and support in the study's preparation. He emphasized the potential benefits of using GMP-grade materials, including improved study interpretability and the ability to address the latest seasonal COVID-19 variant concurrently.
The samRNA technology underpinning Gritstone's vaccine candidate is designed to amplify the antigen RNA within the cell, potentially leading to prolonged and heightened antigen expression. The vaccine integrates both Spike and non-Spike antigens to induce a robust immune response, with the promise of lower dosage requirements and refrigerator stability.
The company's approach with its next-generation vaccines aims to induce a strong and lasting immune response by training multiple arms of the immune system to target critical disease areas. Gritstone bio continues to work on a portfolio of product candidates for the treatment and prevention of viral diseases and solid tumors.
This announcement is based on a press release statement from Gritstone bio.
InvestingPro Insights
As Gritstone bio, Inc. (NASDAQ: GRTS) prepares for its Phase 2b trial for a next-generation COVID-19 vaccine, financial metrics and analyst insights from InvestingPro paint a broader picture of the company's current market standing and future expectations.
InvestingPro Data highlights that Gritstone bio has a market capitalization of 214.52 million USD, indicating its size within the biotechnology industry. The company's revenue for the last twelve months as of Q3 2023 stands at 10.22 million USD, which has seen a significant decline of 45.47%. Additionally, the company's gross profit margin during the same period was notably negative at -1109.66%, showing the company's challenges in maintaining profitability.
InvestingPro Tips suggest caution as the company is rapidly burning through cash and analysts have revised their earnings downwards for the upcoming period. Moreover, they do not anticipate Gritstone bio will be profitable this year, which could be a concern for potential investors. On a more positive note, the company's liquid assets exceed its short-term obligations, providing some financial stability in the near term.
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