Gritstone bio(GRTS) - 2024 Q1 - Quarterly Results

Q1 2024 Financial Results and Corporate Updates Executive Summary and Key Highlights Gritstone bio reported Q1 2024 results, highlighting a favorable PFS trend for its GRANITE vaccine and advancements in its neoantigen platforms - A favorable progression-free survival (PFS) trend was observed in preliminary data from the randomized Phase 2 study of GRANITE in metastatic MSS-CRC, with mature PFS data expected in Q3 2024[1] - A Nature Medicine publication on the SLATE platform and improvements to the EDGE™ platform highlight Gritstone's leadership in the neoantigen-directed cancer vaccine field[1] - The CEO noted the promising preliminary Phase 2 GRANITE data suggests a potential benefit in metastatic CRC patients and aims to unlock immunologically 'cold' tumors for potential Phase 3 discussions[2] Corporate Developments Gritstone completed a public offering raising $32.5 million in gross proceeds and appointed a seasoned biotechnology finance executive to its Board of Directors - Completed an underwritten public offering in April 2024, resulting in gross proceeds of $32.5 million[4][5] - Appointed Stephen Webster, a veteran finance executive with over 30 years in the biotechnology industry, to its Board of Directors in April 2024[5][6] Clinical Program Updates Tumor-Specific Neoantigen Oncology Programs The company updated its oncology programs, noting promising GRANITE data, EDGE™ platform advancements, and an ongoing NCI collaboration GRANITE – Personalized Neoantigen Vaccine Program Preliminary Phase 2 results for GRANITE in metastatic MSS-CRC showed a favorable PFS trend and aligning ctDNA data, with mature data expected in Q3 2024 - Preliminary results from the Phase 2 study in metastatic MSS-CRC demonstrated a favorable trend in progression-free survival (PFS)[8] | Metric | Overall Population (less mature data) | High-Risk Group (more mature data) | | :----- | :------------------------------------ | :--------------------------------- | | Hazard Ratio (PFS) | 0.82 (18% relative risk reduction) | 0.52 (48% relative risk reduction) | | 95% CI | [95% CI, 0.34-1.67]; 62% censored | [95% CI, 0.15-1.38]; 44% censored | - In the high-risk group, ctDNA shifted from high to low in 56% of GRANITE patients vs 22% of control patients, with progressive disease observed in 44% vs 78%, respectively[8] - Gritstone expects to share mature PFS data and additional long-term ctDNA data in the third quarter of 2024[8] SLATE – "Off-the-Shelf" Neoantigen Vaccine Program The SLATE platform's development was detailed in Nature Medicine, and a clinical trial collaboration with the NCI is ongoing - A March 2024 Nature Medicine paper detailed the SLATE platform's development and the discovery of a novel immunodominance hierarchy of tumor neoantigens[8][9] - A clinical trial collaboration with the National Cancer Institute (NCI) is ongoing to evaluate SLATE-KRAS in combination with TCR-T cell therapy[9] EDGE™ – Tumor Antigen Identification Platform The EDGE™ platform now predicts HLA Class I presentation with over 80% accuracy, and a new model, EDGE-II, shows superior predictive performance - The EDGE™ neoantigen prediction platform now predicts HLA Class I presentation with >80% accuracy, a performance level believed to be field-leading[8] - A new model, EDGE-II, has achieved superior predictive performance of HLA Class II presentation and CD4+ immunogenicity over publicly available models[8] Infectious Disease Programs Gritstone updated its CORAL vaccine program, noting a study delay to incorporate GMP-grade materials, and the ongoing HIV collaboration with Gilead CORAL – Next-Generation SARS-CoV-2 Vaccine Program The CORAL Phase 2b study is delayed to incorporate GMP-grade materials, while Phase 1 results highlighted durable and broad immune responses - Gritstone announced a delay of the CORAL Phase 2b study to incorporate GMP-grade materials and increase its regulatory utility[13] - Phase 1 CORAL-CEPI study results highlighted the durability and potential broad utility of its samRNA vaccine, reinforcing findings of broad and durable immune responses through 12 months[13] HIV – Collaboration with Gilead The collaboration with Gilead to develop a vaccine-based HIV immunotherapy treatment continues under Gilead's direction - The collaboration to research and develop a vaccine-based HIV immunotherapy treatment continues under Gilead's direction[11] Detailed Financial Statements First Quarter 2024 Financial Summary The company's Q1 2024 net loss increased to $40.4 million, driven by higher operating expenses, while cash and equivalents decreased to $52.8 million | Metric | Q1 2024 (in millions) | Q1 2023 (in millions) | Change (YoY) | | :----- | :-------------------- | :-------------------- | :----------- | | Cash, cash equivalents, marketable securities and restricted cash (as of period end) | $52.8 | $86.9 (as of Dec 31, 2023) | -$34.1 | | Research and development expenses | $33.0 | $30.5 | +$2.5 | | General and administrative expenses | $8.5 | $6.7 | +$1.8 | | Collaboration, license, and grant revenues | $1.7 | $2.4 (Total revenues) | -$0.7 | | Net loss | -$40.4 | -$34.0 | -$6.4 | | Net loss per share, basic and diluted | -$0.34 | -$0.30 | -$0.04 | - Research and development expenses increased by $2.5 million, primarily due to a one-time severance charge and higher facilities-related costs[13] - General and administrative expenses increased by $1.8 million, mainly attributable to higher personnel-related expenses, facilities costs, and a one-time severance charge[13] - Q1 2024 revenues included $0.4 million in grant revenue from BARDA, $1.0 million from CEPI, and $0.3 million from the Gates Foundation[14] Condensed Consolidated Balance Sheets Total assets decreased to $137.2 million as of March 31, 2024, driven by a reduction in cash, cash equivalents, and marketable securities | Metric (in thousands) | March 31, 2024 | December 31, 2023 | Change | | :-------------------- | :------------- | :---------------- | :----- | | Cash and cash equivalents | $42,395 | $62,986 | -$20,591 | | Marketable securities | $3,908 | $16,288 | -$12,380 | | Total current assets | $51,853 | $87,435 | -$35,582 | | Total assets | $137,212 | $177,769 | -$40,557 | | Total current liabilities | $25,870 | $27,339 | -$1,469 | | Total liabilities | $123,248 | $125,919 | -$2,671 | | Total stockholders' equity | $13,964 | $51,850 | -$37,886 | Condensed Consolidated Statements of Operations and Comprehensive Loss For Q1 2024, total revenues decreased to $1.7 million while the net loss widened to $40.4 million due to increased operating expenses | Metric (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :-------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Collaboration and license revenues | $49 | $542 | -$493 | | Grant revenues | $1,693 | $1,901 | -$208 | | Total revenues | $1,742 | $2,443 | -$701 | | Research and development expenses | $33,041 | $30,514 | +$2,527 | | General and administrative expenses | $8,502 | $6,745 | +$1,757 | | Total operating expenses | $41,543 | $37,259 | +$4,284 | | Loss from operations | $(39,801) | $(34,816) | -$4,985 | | Interest income | $712 | $1,678 | -$966 | | Interest expense | $(1,296) | $(844) | -$452 | | Net loss | $(40,385) | $(33,982) | -$6,403 | | Net loss per share, basic and diluted | $(0.34) | $(0.30) | -$0.04 | Company Information and Disclosures About Gritstone bio Gritstone bio is a clinical-stage biotechnology company developing potent vaccines to treat and prevent viral diseases and solid tumors - Gritstone bio, Inc (Nasdaq: GRTS) is a clinical-stage biotechnology company that aims to develop the world's most potent vaccines[16] - The company leverages innovative vectors and payloads to treat and prevent viral diseases and solid tumors[16] Forward-Looking Statements and Disclaimer This section outlines the forward-looking nature of statements in the press release, highlighting inherent risks in drug development - The press release contains forward-looking statements related to clinical development plans and data expectations, which involve substantial risks and uncertainties[17] - The drugs discussed are under clinical investigation, have not yet been approved for marketing by the FDA, and are limited to investigational use[18] Contacts Contact information for investor relations and media inquiries is provided for Gritstone bio - Investors can contact George E MacDougall at ir@gritstone.com[19] - Media can contact Dan Budwick at 1AB, dan@1abmedia.com[19]