Gritstone bio Q2 2024 Financial Results and Corporate Updates

Gritstone bio, Inc., a clinical-stage biotechnology company focused on creating highly potent vaccines, has released its second-quarter financials for the period ending June 30, 2024. The company is making significant strides in various therapeutic areas, especially in the development of personalized neoantigen vaccines for cancer and innovative vaccines for infectious diseases.

CEO Andrew Allen, MD, PhD, highlighted Gritstone's advancements in treating metastatic microsatellite-stable colorectal cancer (MSS-CRC). MSS-CRC affects up to 95% of metastatic colorectal cancer patients, who currently see limited benefits from existing immunotherapies. Preliminary Phase 2 data indicate that their personalized neoantigen vaccine, GRANITE, shows promising progression-free survival (PFS) advantages in this tough-to-treat population. Mature PFS data is expected by the third quarter of 2024.

In addition to GRANITE, Gritstone is also progressing other programs. Their proprietary platform, EDGE™, which excels in neoantigen identification, was recently showcased at the American Association for Cancer Research (AACR) meeting. Another notable presentation at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) demonstrated their self-amplifying mRNA vector's (samRNA) capability to induce enduring immune responses.

Corporate developments include a completed public offering in April 2024 that raised $32.5 million and the appointment of Stephen Webster to the Board of Directors. Webster, with over 30 years in biotech finance, brings extensive experience to the company. Furthermore, Gritstone has engaged with the Colorectal Cancer Alliance and Paltown Development Foundation to better support and educate colorectal cancer patients and their caregivers.

In clinical updates, preliminary Phase 2 results suggest that GRANITE could significantly benefit patients with metastatic MSS-CRC. While data are still maturing, initial findings show extended PFS in patients treated with GRANITE compared to controls. Specifically, a hazard ratio of 0.82 indicates an 18% reduction in the risk of progression or death. For high-risk, fast-progressing patients, the hazard ratio improves to 0.52, indicating a 48% reduction in risk.

The EDGE™ platform's accuracy in predicting HLA Class I presentation exceeds 80%. Gritstone’s collaboration with the National Cancer Institute (NCI) continues, focusing on a mutant KRAS-directed TCR-T cell therapy combined with SLATE-KRAS, an “off-the-shelf” vaccine candidate.

In the infectious disease domain, Gritstone's next-generation SARS-CoV-2 vaccine program, CORAL, serves as a proof-of-concept for their samRNA platform. Ongoing efforts aim to initiate a head-to-head Phase 2b study under a BARDA contract. Initial Phase 1 data indicate that the samRNA COVID-19 vaccine induces durable immune responses lasting up to 12 months.

Gritstone is also collaborating with Gilead to develop vaccine-based HIV immunotherapy. This partnership aims to create innovative treatment options for HIV patients.

Financially, Gritstone reported cash, cash equivalents, marketable securities, and restricted cash totaling $61.7 million as of June 30, 2024, up from $52.8 million on March 31, 2024. The company saw research and development expenses decrease to $20.8 million compared to $31.0 million in the same quarter of the previous year. This reduction is attributed to lower personnel-related costs, laboratory supplies, external services, and facility-related expenses. On the other hand, general and administrative expenses rose to $7.7 million, primarily due to increased personnel-related costs and non-cash stock-based compensation.

In conclusion, Gritstone bio is at a pivotal stage with promising clinical data and strategic corporate advancements. The company remains committed to leveraging its innovative vaccine technologies to address unmet needs in oncology and infectious diseases, aiming to improve patient outcomes and advance healthcare.