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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 (Nasdaq: GRTS), a clinical-stage biotechnology company, has voluntarily filed for Chapter 11 bankruptcy in Delaware. The company aims to preserve value and support its ongoing strategic alternatives process through this court-administered restructuring. Gritstone is in discussions with a potential stalking horse bidder or plan sponsor and intends to present an agreement to the Court soon.
Despite reporting encouraging interim Phase 2 data for their GRANITE study, Gritstone requires additional time for data maturation. The company plans to continue operating normally, advancing clinical programs, and driving innovation in immunotherapy and vaccine development. Gritstone is filing customary 'first day' motions to ensure minimal impact on vendors, employees, and stakeholders.
Gritstone bio announced encouraging interim Phase 2 data for GRANITE, its individualized neoantigen targeting immunotherapy, in frontline microsatellite stable colorectal cancer (MSS-CRC). The study showed a 21% relative risk reduction of progression or death with GRANITE vs. control in all treated population (HR=0.79). In the low ctDNA subgroup, there was a 38% relative risk reduction (HR=0.62). The strength of neoantigen-specific T cell responses in GRANITE patients appears to associate with progression-free survival. GRANITE was generally well-tolerated with no treatment discontinuations due to adverse events. Overall survival data is expected in 2H 2025.
The study included 104 randomized patients, with 69 in the treated analysis. GRANITE demonstrated a favorable safety profile, with common adverse events being mild systemic and local effects associated with potent vaccines. Gritstone plans to review the PFS data with FDA and discuss next steps, including a potential Phase 2 or 3 trial using ctDNA levels as eligibility criteria.
Gritstone bio (GRTS) reported Q2 2024 financial results and provided corporate updates. Key highlights:
- Preliminary Phase 2 data suggest GRANITE could benefit front-line metastatic MSS-CRC patients; mature PFS data expected in Q3 2024
- Cash position of $61.7 million as of June 30, 2024
- Completed $32.5 million public offering in April 2024
- Appointed Stephen Webster to Board of Directors
- Engaged with patient advocacy groups for colorectal cancer
- Presented data at AACR 2024 and ESCMID 2024 showcasing vaccine technologies
- R&D expenses decreased to $20.8 million in Q2 2024 from $31.0 million in Q2 2023
- G&A expenses increased to $7.7 million in Q2 2024 from $6.7 million in Q2 2023
- Recorded $0.9 million in grant revenue from CEPI in Q2 2024
Gritstone bio (Nasdaq: GRTS) is hosting a virtual key opinion leader (KOL) event on August 2, 2024, at 9:00 AM ET. The event will feature Dr. J. Randolph Hecht from UCLA and Howard Brown, a colorectal cancer survivor and advocate. They will discuss the unmet needs and current treatment landscape for metastatic microsatellite stable colorectal cancer (MSS-CRC).
Gritstone management will highlight their personalized neoantigen vaccine program, GRANITE, as a potential treatment for immunologically "cold" tumors, including MSS-CRC. The company expects to release mature progression-free survival data from a randomized Phase 2 study of GRANITE in frontline MSS-CRC in Q3 2024. The event will conclude with a live Q&A session.
On July 10, 2024, Gritstone bio announced the issuance of nonqualified stock options to a new employee. The options permit the purchase of 39,000 common shares at $0.57 per share, matching the closing price on July 3, 2024. This grant is an inducement for the new hire, aligning with Nasdaq Listing Rule 5635(c)(4). The options will vest over four years, with 25% vesting after one year and the remainder vesting monthly over the next three years, contingent on continued employment. These options are governed by Gritstone’s 2021 Employment Inducement Incentive Award Plan.
Gritstone bio (Nasdaq: GRTS) announced that its Compensation Committee granted one new employee nonqualified stock options for 6,850 shares at an exercise price of $0.75, matching the closing price on June 7, 2024. These options, part of an inducement under Nasdaq Listing Rule 5635(c)(4), will vest over four years: 25% on the first anniversary of the hire date, and 1/48th monthly thereafter. The options are subject to the 2021 Employment Inducement Incentive Award Plan's terms.
Gritstone bio, a clinical-stage biotechnology company, announced its participation in several upcoming investor and scientific conferences. The events include:
1. Goldman Sachs 45th Annual Global Healthcare Conference on June 11, 2024, in Miami, FL.
2. JonesHealthcare Seaside Summit 2024 from July 15-16 in Encinitas, CA.
3. 4th Annual mRNA-Based Therapeutics Summit on July 30, 2024, in Boston, MA.
Some events will be webcasted live, with details available on Gritstone bio’s website.
Gritstone bio, Inc. (Nasdaq: GRTS) reported promising preliminary data for its GRANITE personalized neoantigen vaccine in front-line metastatic colorectal cancer. The company also highlighted advancements in its SLATE and EDGE platforms. Gritstone raised $32.5 million in April 2024 and appointed a new board member. Financially, the company's cash reserves decreased to $52.8 million in Q1 2024, with increased R&D and administrative expenses.
Gritstone bio, Inc. (Nasdaq: GRTS) will report its first-quarter 2024 financial results and provide corporate updates on May 9, 2024. The company, a clinical-stage biotechnology firm focused on developing potent vaccines, will hold a conference call and webcast at 4:30 pm ET on the same day. Interested parties can access the event via phone or webcast.
Gritstone bio presented updated Phase 1 data at ESCMID Global 2024, showcasing the durability and broad utility of its self-amplifying mRNA COVID-19 vaccine. IgG levels, neutralizing antibodies, and T cell responses persisted for at least 12 months. The samRNA vaccine exhibited strong immunogenicity across different patient populations, including those living with HIV.
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