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Gritstone bio, Inc. (Nasdaq: GRTS) is at the forefront of developing personalized cancer immunotherapies and next-generation vaccines for infectious diseases. Headquartered in Emeryville, California, with additional key functions in Cambridge, Massachusetts, Gritstone is a clinical-stage biotechnology company leveraging innovative vectors and payloads to train the immune system to combat critical disease targets. Founded in 2015 with a strong financial backing of $102 million in Series A financing, Gritstone brings together a distinguished team of scientific founders, an experienced management team, and a successful board of directors.
Gritstone's pipeline includes multiple product candidates targeting solid tumors and viral diseases. Their key programs include GRANITE, a personalized neoantigen vaccine program, and SLATE, an 'off-the-shelf' neoantigen vaccine program. Additionally, they are developing CORAL, a next-generation SARS-CoV-2 vaccine designed to drive both B cell and T cell immunity using self-amplifying mRNA (samRNA). Gritstone's collaboration with the National Cancer Institute (NCI) and other industry leaders underscores the pioneering vision and scientific rigor that guides their innovative approaches.
Recent clinical updates have highlighted promising preliminary Phase 2 data for GRANITE in metastatic colorectal cancer (MSS-CRC), showing a progression-free survival benefit. SLATE-KRAS, a variant of their 'off-the-shelf' neoantigen vaccine, has also demonstrated superior immunogenicity in Phase 2 studies. Additionally, their CORAL program continues to show robust and durable immune responses in diverse populations, including those living with HIV.
Gritstone's financial condition remains strong, bolstered by recent public offerings and continued support from prominent foundations and government agencies. Their latest corporate developments and financial results reflect a clear trajectory towards advancing their clinical programs and achieving regulatory milestones.
Gritstone bio, Inc. (Nasdaq: GRTS) announced results from its SLATE v1 neoantigen immunotherapy, showing molecular responses in patients with NSCLC who previously failed immunotherapy. SLATE v1 demonstrated efficacy, with significant ctDNA decreases and an unconfirmed RECIST response. The company has initiated Phase 2 testing of SLATE v2, optimized for KRAS neoantigens, aiming to enhance immune responses. The v2 trial will enroll 60 patients with KRAS-driven tumors, receiving combined therapies with nivolumab and ipilimumab. Initial data is expected by mid-2022.
Gritstone bio, Inc. (Nasdaq: GRTS) announced promising data from its GRANITE individualized immunotherapy, which showed a 44% molecular response rate in advanced colorectal cancer (CRC) patients with 'cold' tumors. The Phase 1/2 study revealed that patients who achieved molecular response had a median overall survival of >17 months, significantly longer than the 7.8 months for those without. Gritstone plans to start Phase 2/3 trials in 1H 2022, aiming for FDA registration. The company highlights a favorable safety profile and robust T-cell response, indicating potential for significant clinical advancements.
Gritstone bio, Inc. (Nasdaq: GRTS) announced a $55 million private investment in public equity (PIPE) financing by selling 5 million shares at $11.00 each. The financing, led by Frazier Life Sciences Public Fund, aims to support the company's growth in immunotherapy and vaccine development, particularly for infectious diseases. The closing is expected by September 17, 2021, subject to customary conditions. Gritstone has committed to filing a registration statement for the resale of these shares. The company develops next-gen immunotherapies through its proprietary Gritstone EDGE™ platform.
Gritstone bio, a clinical-stage biotechnology company, announced a data update webcast on September 17, 2021, during the ESMO Annual Meeting. This event will focus on the Phase 1/2 data from its GRANITE immunotherapy program for advanced solid tumors, along with data from the SLATE shared neoantigen immunotherapy program targeting KRAS mutations. Presenters include Dr. Andrew Allen, Dr. Daniel Catenacci, and Dr. Thierry Andre. Registration for the webcast is available on Gritstone's website, with a replay accessible the following day.
Gritstone bio (Nasdaq: GRTS), a clinical-stage biotech firm, announced its participation in two investor conferences this September. The H.C. Wainwright 23rd Annual Global Investment Conference is scheduled for September 13, 2021, at 7:00 a.m. ET, featuring a presentation by CEO Andrew Allen. The Cantor Virtual Global Healthcare Conference will follow on September 29, 2021, at 2:40 p.m. ET, with CFO Celia Economides presenting. The webcasts will be accessible on the company's website and archived for 30 days.
Gritstone bio, Inc. (Nasdaq: GRTS) has secured funding of up to $20.6 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to advance its CORAL COVID-19 vaccine program. This funding will support a Phase 1 clinical trial in South Africa, focusing on a second-generation vaccine utilizing self-amplifying mRNA technology to elicit a robust immune response against SARS-CoV-2 variants. The study aims to optimize dosing and antigenic content across diverse populations, including the elderly and immunocompromised.
Gritstone bio, Inc. (Nasdaq: GRTS) announced the granting of nonqualified stock options to eight employees, totaling 240,250 shares, at an exercise price of $7.29, equal to the closing stock price on August 11, 2021. These grants are part of an inducement for new hires and will vest over four years. The company is advancing immunotherapy programs for cancer and infectious diseases, including an individualized neoantigen-based treatment and a second-generation COVID-19 vaccine. The press release also includes forward-looking statements about ongoing clinical trials and potential risks involved.
Gritstone bio, Inc. (Nasdaq: GRTS) will host a KOL webinar on its colorectal cancer neoantigen programs on August 18, 2021, at 11 AM ET. KOL Michael J. Overman, M.D. from MD Anderson will present the unmet needs in colorectal cancer treatment and the role of ctDNA. CEO Dr. Andrew Allen will discuss how Gritstone's immunotherapy approach targets tumor-specific neoantigens and will preview data from the Phase 1/2 GRANITE trial, which has completed patient enrollment. Key findings will be presented at the upcoming European Society of Medical Oncology (ESMO) conference in September.
Gritstone bio reported significant developments in its clinical-stage programs and financial results for Q2 2021. The company has completed enrollment in its Phase 2 expansion cohorts of the GRANITE trial for advanced solid tumors. Financially, Gritstone held $176.2 million in cash and equivalents as of June 30, 2021, up from $172.1 million at the end of 2020. Research and development expenses rose to $22.1 million due to increased personnel costs. Collaboration revenue surged to $2.8 million, driven by a partnership with Gilead, compared to $0.5 million in Q2 2020.
On July 15, 2021, Gritstone bio (Nasdaq: GRTS) announced the grant of nonqualified stock options to five employees, totaling 77,800 shares at an exercise price of $8.77, effective July 12, 2021. Additionally, the new CFO, Celia Economides, received options for 215,000 shares at $9.76, based on a June 23, 2021 closing price. These stock options vest over four years, starting with 25% on the first anniversary. This grant aligns with Nasdaq regulations and aims to incentivize employee retention, crucial for Gritstone's ongoing immunotherapy developments.
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