Gossamer Bio reports Q1 EPS (20c) vs. (16c) last year

Reports Q1 revenue $17M vs. $9.9M last year. “We are executing across multiple fronts at Gossamer,” said Faheem Hasnain, Chairman, Co-Founder, and CEO of Gossamer Bio (GOSS). “We have secured an in-person Pre-NDA Type B meeting with the FDA, reflecting our conviction in both the breadth of the PROSERA dataset and in the totality of evidence supporting seralutinib. Subject to the outcomes of that meeting, we expect to submit an NDA for seralutinib in PAH in September of this year. We see a regulatory path forward, toward an NDA submission, and we are executing against it. The PROSERA CT FRI substudy results further strengthen our confidence in seralutinib. For the first time in a controlled PAH trial, we saw statistically significant imaging signals not only in the arterial compartment, but also across the venous vasculature and the parenchyma, and these signals correlated with clinical outcomes. This expands the seralutinib story well beyond arterial remodeling and provides structural evidence that seralutinib is acting across the lung in a manner consistent with its mechanism of action, even in a well-treated patient population. We have also taken steps to address our capital structure through a proposed exchange of our convertible notes, which we believe will strengthen our balance sheet as we approach this pivotal regulatory milestone. Our focus remains on disciplined execution as we look to advance seralutinib and prepare for the next phase of the Company’s growth.”