Gritstone bio(US:GRTS)2022-11-03 20:18Clinical Programs - Gritstone's GRANITE program has shown a median overall survival of >18 months for patients with microsatellite stable colorectal cancer (MSS-CRC) who demonstrated a molecular response, compared to 7.8 months for those without[201]. - The SLATE program demonstrated a molecular response rate (MRR) of 39% in evaluable patients with advanced non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), comparable to the 44% MRR seen in the GRANITE studies[206]. - Gritstone's oncology programs utilize a heterologous prime-boost approach to activate tumor-specific neoantigens, with GRANITE being individualized and SLATE being off-the-shelf[199]. - The company has initiated a randomized Phase 2/3 study (GRANITE-CRC-1L) for MSS-CRC patients, with initial data expected in Q4 2023[202]. - The CORAL program targets COVID-19 with a second-generation prophylactic vaccine, demonstrating robust immune responses in preclinical and clinical studies[207]. - The CORAL program is a second-generation SARS-CoV-2 vaccine platform that aims to provide more durable protection and broader immunity against variants compared to first-generation vaccines[208]. - Preclinical studies demonstrated significant and sustained levels of neutralizing antibodies and T cells against the Spike protein, with results published in Nature Communications in June 2022[209]. - Four distinct SARS-CoV-2 product candidates are currently being evaluated across three different Phase 1 clinical trials, with data expected in Q4 2022[210]. Financial Performance - For the three months ended September 30, 2022, total revenues were $3.0 million, a slight increase from $2.6 million in the same period in 2021[230]. - The company recognized $15.7 million in total revenues for the nine months ended September 30, 2022, compared to $45.15 million in the same period in 2021, indicating a decline of $29.47 million[231]. - Collaboration and license revenues for the nine months ended September 30, 2022, were $7.94 million, a significant decrease from $44.94 million in the same period in 2021[230]. - The net loss for the nine months ended September 30, 2022, was $88.40 million, compared to a net loss of $45.31 million in the same period in 2021, reflecting an increase in losses of $43.08 million[230]. - The company expects to continue recognizing revenue from collaboration agreements and may generate revenue from product sales in the future[217]. Research and Development Expenses - Research and development expenses for the nine months ended September 30, 2022, were $81.98 million, up from $71.32 million in the same period in 2021, reflecting a $10.66 million increase[230]. - Research and development expenses increased to $26.4 million and $82.0 million for the three and nine months ended September 30, 2022, compared to $24.4 million and $71.3 million for the same periods in 2021[234]. Cash Flow and Financial Position - Cash used in operating activities was $85.6 million for the nine months ended September 30, 2022, compared to $26.9 million in 2021[258]. - The company had cash, cash equivalents, and marketable securities of $139.8 million as of September 30, 2022, down from $206.3 million as of December 31, 2021[241]. - The accumulated deficit increased to $489.8 million as of September 30, 2022, compared to $401.4 million at the end of 2021[241]. - The company expects to continue incurring net operating losses for at least the next several years as it advances its product candidates through clinical development[251]. - Cash provided by financing activities was $18.7 million for the nine months ended September 30, 2022, compared to $75.9 million in 2021[258]. - During the nine months ended September 30, 2022, cash provided by investing activities was $33.2 million, consisting of $102.2 million in proceeds from the maturity of marketable securities, offset by $64.6 million in purchases of marketable securities[261]. Collaborations and Agreements - The company has entered into a collaboration with Gilead Sciences to develop an HIV-specific therapeutic vaccine, with a potential $40 million non-refundable option exercise fee if Gilead progresses beyond Phase 1[214]. - The company is obligated to pay up to $36.4 million in milestone payments related to a contract research and development agreement, with no milestones achieved as of September 30, 2022[270]. General and Administrative Expenses - General and administrative expenses were $6.5 million for the three months ended September 30, 2022, compared to $6.4 million for the same period in 2021, and $22.2 million for the nine months ended September 30, 2022, compared to $19.2 million in 2021[237][238]. Other Financial Information - Interest income was $0.5 million and $0.7 million for the three and nine months ended September 30, 2022, compared to immaterial amounts in the same periods of 2021[239]. - The company has future minimum lease payments totaling $108.1 million under lease agreements, with $2.5 million due in the fourth quarter of 2022[268]. - The company has not entered into any off-balance sheet arrangements as defined under SEC rules[267]. - There have been no changes to critical accounting policies since the last Annual Report filed on March 10, 2022[275]. - There have been no material changes in market risk since the last Annual Report filed for the year ended December 31, 2021[277].