Gritstone bio Q1 2024 Financial Results & Corporate Updates

Gritstone bio, Inc. has announced its financial outcomes for the first quarter ending March 31, 2024, along with updates on its corporate and clinical activities. Dr. Andrew Allen, the Co-founder, President, and CEO, shared insights on the recent preliminary Phase 2 data for GRANITE, a personalized neoantigen vaccine used as a front-line treatment for metastatic microsatellite-stable colorectal cancer (MSS-CRC). The encouraging progression-free survival (PFS) trend observed in the study indicates a potential benefit for patients, suggesting that immunologically ‘cold’ tumors might soon be responsive to immunotherapy. Dr. Allen anticipates further maturity of the PFS data by the third quarter of 2024, which could catalyze a Phase 3 study engagement with regulators.

Gritstone's other significant programs also showed progress. A recent publication in Nature Medicine emphasized the scientific competence of the SLATE platform, marking the discovery of a neoantigen immunodominance hierarchy. This discovery supports the ongoing collaboration with the National Cancer Institute (NCI) to evaluate the SLATE-KRAS vaccine alongside T cell therapy. Additionally, the company has made advancements with the EDGE™ platform, a tumor antigen identification system that utilizes artificial intelligence for accurate prediction of HLA Class I and Class II presentations.

In April 2024, Gritstone completed a public offering, raising $32.5 million in gross proceeds. This financial boost aligns with the appointment of Stephen Webster to the Board of Directors, bringing over 30 years of biotechnology finance experience. Webster’s notable previous role includes serving as Chief Financial Officer at Spark Therapeutics until its acquisition by Roche.

The clinical program updates emphasize the potential and progress of various initiatives. The GRANITE program showed a favorable trend in PFS as a maintenance therapy for MSS-CRC. Preliminary data from a randomized Phase 2 study involving 67 patients highlighted a reduction in the relative risk of progression or death, especially in high-risk groups where ctDNA levels were above the median value. This data is expected to mature with further analysis by the third quarter of 2024.

The SLATE program also made notable strides. A Phase 1 study outlined in Nature Medicine revealed a hierarchy of tumor neoantigens, aiding the development of the SLATE-KRAS vaccine. This vaccine, designed to address specific neoantigens, showed superior immunogenicity in subsequent studies. The collaboration with the NCI is ongoing, focusing on combining the SLATE-KRAS vaccine with autologous T cell therapy to enhance treatment effectiveness.

On the infectious disease front, the CORAL program, which focuses on next-generation SARS-CoV-2 vaccines, demonstrated promising durability and utility. Gritstone’s self-amplifying mRNA (samRNA) technology showcased broad and long-lasting immune responses in a Phase 1 study conducted in South Africa. However, to enhance the regulatory utility, Gritstone decided to incorporate GMP-grade materials in the manufacture of its samRNA candidate, delaying the anticipated Phase 2b study.

In the HIV domain, Gritstone continues its collaboration with Gilead to develop vaccine-based immunotherapy treatments under the HIV Cure Program. This partnership aims to advance research and develop effective treatments for HIV.

Financially, Gritstone reported a decrease in its cash and cash equivalents to $52.8 million as of March 31, 2024, from $86.9 million on December 31, 2023. Research and development expenses for the first quarter of 2024 increased to $33.0 million, attributed primarily to a one-time severance charge and facilities-related costs. General and administrative expenses also rose to $8.5 million due to personnel-related and facilities costs. Revenues from collaborations, licenses, and grants for the first quarter of 2024 amounted to $1.7 million.

Gritstone remains committed to advancing its portfolio of innovative vaccines and treatments, aiming to improve patient outcomes across various diseases, including cancer and viral infections.