EMERYVILLE, Calif. -
Clinical-stage biotechnology company Gritstone bio, Inc. (NASDAQ:GRTS) has unveiled interim Phase 2 data that suggests its individualized immunotherapy GRANITE may reduce the risk of disease progression or death in patients with microsatellite stable colorectal cancer (MSS-CRC). The study, which is still ongoing, is evaluating GRANITE in combination with standard cancer treatments.
The data released today indicates a 21% relative risk reduction in the overall treated population and a 38% reduction in a subgroup with low circulating tumor DNA (ctDNA), a marker of disease burden. These results are based on a data cut as of August 19, 2024, and involve 104 patients who were randomized to receive either GRANITE or a control.
According to the company, the strength of neoantigen specific T cell responses in patients treated with GRANITE correlates with the observed progression-free survival (PFS). The treatment was generally well-tolerated, with no discontinuations due to adverse events reported.
Gritstone's President & CEO, Andrew Allen, M.D., Ph.D., expressed optimism about GRANITE's potential to extend progression-free survival in a disease that typically progresses despite existing therapies. The company plans to discuss the PFS data with the FDA in the near future to determine the next steps, which may include advancing to a Phase 2 or 3 trial.
While the overall survival data is expected in the second half of 2025, Gritstone is actively seeking strategic and funding options to further the development of its immunotherapy. The company has engaged Raymond James as its financial advisor to assist in reviewing potential strategies.
The press release emphasizes that the findings are preliminary and that more time is needed for the data to mature, especially in the low ctDNA subgroup where events accumulate more slowly. This announcement is based on a press release statement from Gritstone bio.
In other recent news, Gritstone bio has been making significant strides in its Phase 2 clinical trials for the GRANITE neoantigen program, with mature progression-free survival (PFS) data expected next month. Analysts from JMP Securities, TD Cowen, and Piper Sandler have all maintained positive ratings on the company's stock. JMP Securities kept a Market Outperform rating, while TD Cowen and Piper Sandler maintained a Buy and Overweight rating, respectively.
During recent meetings, Gritstone management engaged with investors on several aspects of the trial, including design, statistical analyses, and previous GRANITE results. The company, which reported a net loss of $23 million for the second quarter with cash reserves of $62 million, also discussed its financial sustainability.
The GRANITE study data, expected in September, is highly anticipated by investors and analysts alike. Piper Sandler also expects overall survival data next year, which could potentially serve as the primary endpoint for a Phase III trial planned to commence in 2025.
Gritstone bio also held its annual stockholders meeting, resulting in the election of Elaine Jones, Ph.D., and Clare Fisher to the Board of Directors. Ernst & Young LLP was ratified as the independent registered public accounting firm for the fiscal year ending December 31, 2024. Stockholders approved the compensation of the company's named executive officers and expressed a preference for an annual advisory vote on such compensation.
InvestingPro Insights
As Gritstone bio (NASDAQ:GRTS) reveals promising interim Phase 2 data for its GRANITE immunotherapy, investors should consider some key financial metrics and insights from InvestingPro.
Despite the positive clinical news, Gritstone's financial position presents some challenges. The company's market capitalization stands at a modest $68.15 million, reflecting the early-stage nature of its pipeline. InvestingPro data shows that Gritstone's revenue for the last twelve months as of Q2 2024 was $14.61 million, with a revenue growth of 25.09% over the same period. However, this growth is tempered by a significant quarterly revenue decline of 52.89% in Q2 2024.
InvestingPro Tips highlight that Gritstone is "quickly burning through cash" and "not profitable over the last twelve months." These factors are critical for a clinical-stage biotech company that requires substantial funding for ongoing research and development. The company's operating income margin of -934.05% underscores the significant costs associated with advancing its pipeline.
On a more positive note, one InvestingPro Tip indicates that "liquid assets exceed short term obligations," suggesting that Gritstone has some financial flexibility in the near term. This could be crucial as the company seeks strategic and funding options to support GRANITE's development.
Investors should also note that Gritstone's stock has shown a "strong return over the last month," with a 26.93% price total return. This recent performance may reflect market optimism about the GRANITE data release. However, it's important to consider that the stock has "taken a big hit over the last six months," with a -76.45% price total return over that period.
For those interested in a deeper dive into Gritstone's financial health and market performance, InvestingPro offers 11 additional tips that could provide valuable insights for investment decision-making.
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