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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, a clinical-stage biotechnology company (Nasdaq: GRTS), announced participation in two investor conferences. The 5th Annual Evercore ISI HealthCONx Conference is scheduled for November 29, 2022, featuring CEO Andrew Allen in a virtual fireside chat. The 34th Annual Piper Sandler Healthcare Conference will take place on December 1, 2022, with CFO Celia Economides and CBO Matthew J. Hawryluk presenting in New York. Live webcasts will be available for both events, and archived replays will be accessible for 30 days afterwards.
Gritstone bio, Inc. (Nasdaq: GRTS) announced updated overall survival (OS) results from its Phase 1/2 study of GRANITE, an individualized vaccine-based immunotherapy for metastatic microsatellite stable colorectal cancer (MSS-CRC). Patients with a molecular response have a median OS exceeding 22 months compared to 7.8 months for those without. This data highlights a significant survival advantage for patients not traditionally expected to benefit from immunotherapy. The ongoing randomized Phase 2/3 GRANITE study is expected to yield preliminary data in 4Q2023.
Gritstone bio, Inc. (NASDAQ: GRTS) reported encouraging developments in its clinical trials, showcasing the potential of self-amplifying mRNA (samRNA) vaccines against infectious diseases and cancer. Initial Phase 2 data from the KRAS-directed SLATE program indicated a molecular response rate of 40% in advanced lung cancer, comparable to prior results in colorectal cancer. The ongoing GRANITE study aims to establish strong data by 4Q2023. Financially, cash reserves totaled $151.8 million as of September 30, 2022, but R&D expenses increased to $26.4 million, suggesting ongoing investment in trials.
Gritstone bio, Inc. (Nasdaq: GRTS) announced a PIPE financing deal to sell 6,637,165 shares at $2.26 each and 13,274,923 pre-funded warrants at $2.2599, expected to generate approximately $45 million. The transaction, led by Redmile Group, is slated to close on October 27, 2022. Proceeds will support ongoing clinical development in oncology and infectious diseases. The securities are unregistered and require a registration statement with the SEC for resale. Gritstone aims to create potent vaccines leveraging innovative vectors for treating viral diseases and solid tumors.
Gritstone bio (GRTS) announced promising Phase 1 results from its CORAL-BOOST and CORAL-CEPI trials, showcasing strong immune responses from its self-amplifying mRNA (samRNA) vaccine candidates against SARS-CoV-2. Key findings include:
- High neutralizing antibody and T cell responses at 6 months post-vaccination
- Good tolerability across all dose levels tested
- Immunogenicity in vaccine-naïve subjects
These results further validate Gritstone's samRNA platform, emphasizing its potential in addressing unmet needs in infectious disease vaccination.
Gritstone bio, Inc. (Nasdaq: GRTS) has announced a webinar on October 25, 2022, to present data from its CORAL program, evaluating samRNA vaccine candidates against SARS-CoV-2. The Phase 1 trials, CORAL-BOOST and CORAL-CEPI, will feature presentations by prominent researchers, including Professor Andrew Ustianowski and Professor Shabir Madhi. Larry Corey, a leading expert in vaccine development, will discuss the broader applications of samRNA vaccines. Attendees can register for the event online and access a replay for 30 days post-event.
Gritstone bio (Nasdaq: GRTS) announced on October 17, 2022, that its Board of Directors granted seven employees stock options to purchase a total of 35,100 shares at an exercise price of $2.24 per share. This price reflects the closing stock price on the grant date, October 11, 2022. The stock options will vest over four years, with 25% vesting on the first anniversary of the hire date and the remainder vesting monthly thereafter. This initiative aligns with Nasdaq rules as an inducement for new hires.
On September 20, 2022, Gritstone bio, Inc. (Nasdaq: GRTS) announced that its Board of Directors granted nonqualified stock options for 12,400 shares to three new employees at an exercise price of $3.59, equal to the stock's closing price on September 9, 2022. These options will vest over four years to incentivize employee retention, with 25% vesting after the first year and the remainder vesting monthly. The grant aligns with Nasdaq Listing Rule 5635(c)(4) and is part of Gritstone's 2021 Employment Inducement Incentive Award Plan.
Gritstone bio (Nasdaq: GRTS) presented promising early results from its SLATE vaccine program at the 2022 ESMO Congress. The SLATE-KRAS vaccine demonstrated a 39% molecular response rate in patients with late-line microsatellite-stable colorectal cancer and non-small cell lung cancer. Notably, a correlation was observed between molecular response and overall survival (OS), with NSCLC patients showing a median OS of 9.6 months. The results indicate potential for earlier treatment lines in advanced cancer therapies, supported by favorable safety profiles and robust immune responses.
Gritstone bio, a clinical-stage biotechnology company, announced its participation in significant upcoming medical conferences. At the 2022 Wells Fargo Healthcare Conference in Boston, the company will present on September 8, 2022, at 1:20 PM EDT, featuring CFO Celia Economides and CBO Matthew J. Hawryluk. Additionally, Gritstone will engage in a fireside chat at the H.C. Wainwright 24th Annual Global Investment Conference on September 13, 2022, at 3:30 PM EDT with CEO Andrew Allen. Both events will be available via webcast on their website.
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