Gritstone bio, Inc.

Gritstone did not report revenue or EPS, but it did report a Q1 2024 net loss of $40.4 million versus $34 million in the prior-year period. Collaboration license and grant revenue was $1.7 million versus $2.4 million a year ago, R&D expense was $33 million versus $30.5 million, and G&A expense was $8.5 million versus $6.7 million. Cash, cash equivalents, marketable securities and restricted cash were $52.8 million at March 31, 2024, and an April underwritten offering brought pro forma cash to about $85.3 million. Management said the workforce reduction of about 40% and the financing extended runway into Q4 2024. Forward, the company expects mature PFS data and additional ctDNA data for GRANITE in Q3 2024, followed by an end-of-Phase II FDA meeting and discussion of the Phase III endpoint, likely PFS or OS.

Andrew Allen framed the quarter around GRANITE and said the early randomized Phase II data are encouraging despite being immature. He emphasized the overall PFS signal, the stronger high-risk subset data, and the lack of pseudoprogression so far as reasons to believe PFS may be a workable regulatory endpoint. He also tied the program to a broader strategy of extending immunotherapy to cold tumors and said the company is advancing other platform assets in oncology and infectious disease.

Celia Economides focused on liquidity, cost actions, and the quarterly loss. She said quarter-end cash was $52.8 million, the April offering added $32.5 million gross proceeds, and these actions plus a roughly 40% workforce reduction reduced burn and extended runway into Q4 2024. She also walked through the Q1 loss of $40.4 million, the $1.7 million of collaboration license and grant revenue, and higher R&D and G&A costs driven in part by one-time severance and impairment charges.

Analysts focused on whether the Q3 GRANITE readout will be mature enough and what bar would count as success; management said they have no reason to doubt the timing and said they would look for a meaningful improvement over the roughly 11-month median PFS, with a hazard ratio probably better than 0.75. Questions also probed the ctDNA endpoint, and management acknowledged the single-time-point ctDNA design was flawed because chemo effects lasted longer than expected, but said the longer-term ctDNA trends still align with the PFS signal. Other questions covered FDA touchpoints, pseudoprogression, the rationale for the high-risk subset, and BARDA/CORAL funding; management said the Phase III population should stay representative, the endpoint discussion with FDA will happen at an end-of-Phase II meeting, and BARDA-funded COVID work is tied to Project NextGen with additional applications through a different BARDA vehicle.