Business
Invivyd Reports Second Quarter 2023 Financial Results and Business Highlights
Reported positive initial Phase 1 VYD222 clinical trial data, including favorable safety data and robust serum neutralizing titers from all three dose levels
About this update from Invivyd, Inc.
[{"type":"text","content":"Reported positive initial Phase 1 VYD222 clinical trial data, including favorable safety data and robust serum neutralizing titers from all three dose levels testedPlans to pursue rapid initiation of a 750-participant pivotal clinical trial of VYD222 (CANOPY) that will utilize Day 28 serum neutralizing titers from a subset of the population as part of a potential EUA submission for the prevention of symptomatic COVID-19The company expects to have initial primary endpoint data from CANOPY by approximately the end of 2023Cash, cash equivalents and marketable securities of $298.4 million expected to support operating runway into the fourth quarter of 2024, excluding potential contribution of commercial product revenueConference call scheduled for Thursday, August 10th at 4:30 p.m. ET WALTHAM, Mass, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced financial results for the quarter ended June 30, 2023, and recent business highlights. “I am very excited with the progress we made in the second quarter. On the heels of positive initial data from our Phase 1 VYD222 clinical trial and productive conversations with the FDA on a rapid pathway to a potential EUA, we are working with urgency to initiate a pivotal clinical trial of VYD222 for the prevention of symptomatic COVID-19, referred to as the CANOPY trial,” said Dave Hering, Chief Executive Officer of Invivyd. “With the size and efficient design of the CANOPY trial, including a primary efficacy endpoint based on the analysis of serum neutralizing titers at Day 28, we believe that we can swiftly enroll the trial and generate the data necessary to enable a potential EUA submission. We’ve continued to see strong interest from our clinical sites and immunocompromised people, with more than 1,000 immunocompromised individuals now in our database of potentially eligible individuals, which speaks to the strong unmet medical need.” Recent VYD222 Program Updates: Plans to initiate VYD222 pivotal clinical trial using a surrogate endpoint to generate the clinical data needed to enable a potential emergency use authorization (EUA) submission: In a pivotal clinical trial of VYD222, referred to as the CANOPY trial, Invivyd plans to enroll approximat...