Core Insights - Gritstone Bio Inc. announced interim Phase 2 data for its individualized neoantigen-targeting immunotherapy, GRANITE, in frontline microsatellite-stable colorectal cancer (MSS-CRC) [1] - The study compares the clinical benefit of GRANITE combined with immune checkpoint inhibitors and fluoropyrimidine/bevacizumab against the standard treatment of fluoropyrimidine/bevacizumab alone [1] Treatment Efficacy - The most significant benefit was observed in the 50% of patients with lower disease burden at study entry, as indicated by circulating tumor DNA (ctDNA) levels [2] - GRANITE showed a 21% relative risk reduction in progression or death compared to standard of care (SOC) [3] - In the low ctDNA subgroup, there was a 38% relative risk reduction in progression or death with GRANITE compared to SOC [3] Future Plans - Gritstone intends to discuss progression-free survival (PFS) data with the FDA and determine next steps for advancing GRANITE, potentially including a Phase 2 or 3 trial using ctDNA levels as eligibility criteria [3] Financial Advisory and Market Reaction - Gritstone has engaged Raymond James as its financial advisor [4] - JMP Securities downgraded Gritstone from Market Outperform to Market Perform, citing limited paths for meaningful upside despite recognizing the fundamentals of GRANITE technology [4] - Following the news, Gritstone's stock price fell by 57.5% to $0.25 [4]

Company Performance - Gritstone bio Inc. reported a quarterly loss of $0.16 per share, which was better than the Zacks Consensus Estimate of a loss of $0.26, and an improvement from a loss of $0.31 per share a year ago, representing an earnings surprise of 38.46% [1] - The company posted revenues of $0.92 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 66.70%, and a decline from year-ago revenues of $1.96 million [2] - Over the last four quarters, Gritstone bio has surpassed consensus EPS estimates three times, but has topped consensus revenue estimates only once [2] Stock Outlook - Gritstone bio shares have lost approximately 76% since the beginning of the year, contrasting with the S&P 500's gain of 12.1% [3] - The current consensus EPS estimate for the coming quarter is -$0.20 on $8.1 million in revenues, and -$1.01 on $13.65 million in revenues for the current fiscal year [7] - The estimate revisions trend for Gritstone bio is currently unfavorable, resulting in a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Gritstone bio belongs, is currently in the top 29% of over 250 Zacks industries, suggesting a favorable industry outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Gritstone bio's stock performance [5]

Financial Position - As of June 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $55.7 million[97]. - As of June 30, 2024, the company had cash, cash equivalents, and marketable securities of $55.7 million, down from $79.3 million as of December 31, 2023[126]. - The company has an accumulated deficit of $723.3 million as of June 30, 2024, and expects to incur substantial additional losses in the future[129]. - The company anticipates that existing cash, cash equivalents, and investments will only be sufficient to fund operations into the fourth quarter of 2024[129]. - Future minimum lease payments total $91.2 million, with $6.5 million due in 2024[136]. Funding and Revenue - The company completed a public offering on April 4, 2024, raising gross proceeds of $32.5 million[97]. - The company has received aggregate proceeds of $33.1 million from its 2022 ATM Offering Program as of June 30, 2024[126]. - For the three and six months ended June 30, 2024, collaboration and license revenues were $0.057 million and grant revenues were $0.864 million, totaling $0.921 million, a decrease of $1.034 million compared to the same period in 2023[109][117]. - The company recognized $0.9 million and $2.7 million in revenue for the three and six months ended June 30, 2024, respectively, from various collaboration agreements[109]. - The company expects to continue recognizing revenue from the Gilead Collaboration Agreement and the CEPI Funding Agreement, with potential fluctuations based on timing and amounts of payments[109]. Research and Development - The ongoing Phase 2 clinical trial for the GRANITE program has enrolled 104 patients, with preliminary data reported for 67 patients[101]. - The SLATE program has demonstrated superior immunogenicity in a Phase 2 trial compared to its initial version, with a focus on KRAS-directed candidates[102]. - The CORAL program has shown high neutralizing antibody levels and broad T cell responses persisting for at least 12 months in multiple Phase 1 trials[105]. - The company expects to report mature progression-free survival data from the GRANITE trial in Q3 2024 and overall survival data in mid-2025[101]. - The GRANITE program targets microsatellite stable colorectal cancer and has been granted Fast Track designation by the FDA[100]. - The company is developing a therapeutic vaccine against HIV in collaboration with Gilead Sciences[103]. - The company is preparing for a Phase 2b study under the BARDA Contract, which includes government funding of up to $10.0 million for certain milestones[106]. - The company anticipates a substantial increase in research and development expenses as it advances product candidates through clinical studies[111]. Expenses and Losses - Research and development expenses for the three months ended June 30, 2024, were $20.811 million, down from $30.967 million in the same period in 2023, reflecting a decrease of $10.156 million[110][117]. - Total research and development expenses for the six months ended June 30, 2024, were $53.852 million, compared to $61.481 million for the same period in 2023[112][117]. - The net loss for the three months ended June 30, 2024, was $23.396 million, an improvement of $11.860 million compared to a net loss of $35.256 million in the same period in 2023[117]. - The company incurred a net loss of $63.8 million for the six months ended June 30, 2024[132]. - General and administrative expenses increased to $16.2 million for the six months ended June 30, 2024, compared to $13.5 million for the same period in 2023, reflecting a $2.7 million increase[121]. - Interest income decreased to $1.4 million for the six months ended June 30, 2024, down from $3.2 million for the same period in 2023[122]. - Interest expense increased to $2.6 million for the six months ended June 30, 2024, compared to $1.8 million for the same period in 2023, due to a higher principal balance under the Loan Agreement[123][124]. - Other income for the six months ended June 30, 2024, was $4.8 million, a significant increase from de minimis amounts in the same period in 2023[125]. - Non-cash charges for the six months ended June 30, 2024, included stock-based compensation of $6.7 million[132]. Going Concern - The company is subject to substantial doubt regarding its ability to continue as a going concern without additional financing[97]. - The company anticipates needing substantial additional funding to support its ongoing operations and product development efforts[128]. - The company may need to significantly reduce operating expenses or delay development programs if additional capital is not raised[129]. - The company is subject to covenants that could restrict operations if indebtedness is incurred[129].

Core Insights - Gritstone bio is advancing its personalized neoantigen vaccine, GRANITE, which shows potential clinical benefits in treating front-line metastatic microsatellite-stable colorectal cancer (MSS-CRC) [1][4] - The company emphasizes the significant unmet need for new treatment options in metastatic colorectal cancer, particularly for the 95% of patients who are MSS and do not respond to current immunotherapies [2] - Financial results indicate a cash position of $61.7 million as of June 30, 2024, reflecting an increase from $52.8 million at the end of the previous quarter [10] Corporate Updates - In April 2024, Gritstone completed a public offering, raising gross proceeds of $32.5 million [3] - The company appointed Stephen Webster to its Board of Directors, bringing over 30 years of experience in the biotechnology industry [3] - Gritstone engaged with patient advocacy groups to enhance education and support for colorectal cancer patients [3] Clinical Program Updates - Preliminary Phase 2 data suggest that GRANITE may provide meaningful clinical benefits in MSS-CRC, with mature progression-free survival (PFS) data expected in Q3 2024 [1][4] - The hazard ratio for GRANITE treatment indicates an 18% relative risk reduction in the overall population and a 48% reduction in a high-risk subgroup [5][6] - The EDGE™ platform, which predicts neoantigen presentation, has shown over 80% accuracy, reinforcing Gritstone's position in neoantigen prediction [6] Infectious Disease Programs - Gritstone is advancing its CORAL program, a next-generation SARS-CoV-2 vaccine, with plans for a Phase 2b study [8] - Follow-up data from the Phase 1 CORAL study indicate durable immune responses lasting up to 12 months [9] - The company is collaborating with Gilead on vaccine-based HIV immunotherapy research [9] Financial Results - Total revenues for Q2 2024 were $0.9 million, a decrease from $1.95 million in Q2 2023 [18] - Research and development expenses decreased to $20.8 million in Q2 2024 from $31 million in the same period last year [11] - The net loss for Q2 2024 was $23.4 million, compared to a net loss of $35.3 million in Q2 2023 [19]

Core Points - Gritstone bio, Inc. (NASDAQ: GRTS) is facing allegations of issuing materially false and misleading statements regarding its COVID-19 vaccine development and the launch of the Phase 2b CORAL Study [1] - The class period for the allegations spans from March 9, 2023, to February 29, 2024, with a deadline for shareholders to register for the class action set for August 6, 2024 [2] Allegations Summary - The company allegedly failed to disclose its inability to launch the Phase 2b CORAL Study within the promised timeframe, which could impair its ability to secure external funding [1] - This failure is said to negatively impact Gritstone's balance sheet and cash position, leading to an overstatement of its capabilities in product development and commercialization [1] - The public statements made by Gritstone during the class period are claimed to be materially false and misleading [1] Next Steps for Shareholders - Shareholders who purchased GRTS shares during the specified timeframe are encouraged to register for the class action to receive updates and monitor the case [2] - There is no cost or obligation for shareholders to participate in the case [2]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Gritstone bio, Inc. securities between March 9, 2023, and February 29, 2024, of the upcoming lead plaintiff deadline on August 6, 2024, for a class action lawsuit [1] Group 1: Class Action Details - Investors who purchased Gritstone securities during the specified class period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [1] - A class action lawsuit has already been filed, and interested parties must move the Court to serve as lead plaintiff by August 6, 2024 [2] - The lawsuit alleges that Gritstone made false and misleading statements regarding its ability to launch the Phase 2b CORAL Study and secure external funding, which negatively impacted its financial position [4] Group 2: Rosen Law Firm's Credentials - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions, highlighting its own achievements in this area [3] - The firm has secured significant settlements for investors, including over $438 million in 2019 and has been ranked highly for its performance in securities class action settlements [3]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Gritstone bio, Inc. securities during the specified class period of the upcoming lead plaintiff deadline for a class action lawsuit [1][2]. Group 1: Class Action Details - Investors who bought Gritstone securities between March 9, 2023, and February 29, 2024, may be eligible for compensation through a contingency fee arrangement [1]. - A class action lawsuit has already been filed, and interested parties must move the Court to serve as lead plaintiff by August 6, 2024 [2]. Group 2: Allegations Against Gritstone - The lawsuit alleges that Gritstone made false and misleading statements regarding its ability to launch the Phase 2b CORAL Study for its COVID-19 vaccine candidate [3]. - It is claimed that Gritstone's inability to launch the study as represented would hinder its ability to secure external funding, negatively impacting its financial stability [3]. - The lawsuit asserts that Gritstone overstated its capacity to develop and commercialize its products, leading to materially false public statements [3].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Gritstone bio, Inc. due to alleged violations of federal securities laws, with a deadline for investors to seek lead plaintiff status in a class action lawsuit by August 6, 2024 [2][4]. Group 1: Allegations Against Gritstone - The complaint alleges that Gritstone and its executives made false and misleading statements regarding the launch of the Phase 2b CORAL Study, which they would be unable to initiate as previously represented [4]. - The delay in launching the study is said to impair Gritstone's ability to secure external funding, negatively impacting its financial stability and cash position [4]. - Gritstone is accused of overstating its capability to develop and commercialize its products, leading to materially false and misleading public statements [4]. Group 2: Impact on Company Operations - On February 12, 2024, Gritstone announced a delay in the launch of the CORAL Study until Fall 2024 to use fully GMP-grade raw materials, which is expected to enhance regulatory utility [5]. - Following this announcement, on February 29, 2024, Gritstone reported a workforce reduction of approximately 40%, attributed to the delay in the study and the lack of anticipated external funding [5]. - The stock price of Gritstone fell by $0.78 per share, or 27.86%, closing at $2.02 per share on March 1, 2024, due to the negative impact of these developments [6]. Group 3: Legal Proceedings and Investor Actions - Investors who suffered losses exceeding $25,000 between March 9, 2023, and February 29, 2024, are encouraged to contact Faruqi & Faruqi to discuss their legal options [1]. - The role of lead plaintiff in the class action is open to any member of the putative class, who can either move the court to serve as lead plaintiff or remain an absent class member [7]. - Faruqi & Faruqi is also seeking information from whistleblowers, former employees, and shareholders regarding Gritstone's conduct [8].

Group 1: Gritstone bio, Inc. - A shareholder class action lawsuit has been filed against Gritstone bio, Inc. alleging that the company made materially false and misleading statements regarding its ability to launch the Phase 2b CORAL Study on time [2] - The lawsuit claims that Gritstone's inability to launch the study would impair its ability to secure external funding, negatively affecting its balance sheet and cash position [2] - It is alleged that Gritstone overstated its capability to successfully develop and commercialize its products [2] Group 2: FAT Brands Inc. - A shareholder class action lawsuit has been filed against FAT Brands Inc. alleging that the company failed to disclose improper payments received by its Chairman and former CEO, exposing it to potential criminal liability [4] - The lawsuit contends that the statements made by the defendants regarding the business, operations, and prospects of FAT Brands were materially false and misleading [4] - The deadline for shareholders who suffered significant losses between March 24, 2022, and May 10, 2024, to seek lead plaintiff status is August 6, 2024 [5]

Core Viewpoint - Gritstone bio, Inc. is facing a federal securities class action due to allegations of misleading statements regarding the launch of its Phase 2b CORAL Study and its financial implications [1][2]. Group 1: Allegations and Impact - The complaint claims that Gritstone and its executives violated federal securities laws by failing to disclose the inability to launch the Phase 2b CORAL Study on time, which would hinder external funding and negatively affect the company's financial health [2]. - Gritstone's stock price dropped by $0.78, or 27.86%, closing at $2.02 per share on March 1, 2024, following the news of the allegations [3]. - On February 29, 2024, Gritstone announced a workforce reduction of approximately 40% due to the delay in the CORAL Phase 2b study, which impacted anticipated external funding [9]. Group 2: Legal Proceedings and Investor Actions - Investors who suffered losses exceeding $25,000 between March 9, 2023, and February 29, 2024, are encouraged to discuss their legal rights and options regarding the class action [6][7]. - The law firm Faruqi & Faruqi is investigating claims and has set an August 6, 2024, deadline for investors to seek the role of lead plaintiff in the class action [1][6].