Gossamer Bio, Inc.

Thank you for standing by. My name is Tina, and I will be your conference operator today. At this time, I would like to welcome everyone to the Gossamer Dio Q1 2026 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. To ask a question, simply press star 1 on your telephone keypad. To withdraw your question, press star 1 again. It is now my pleasure to turn the call over to Brian Gerardo, Chief Operating Officer and Chief Financial Officer. Please go ahead.

Good morning, and thank you for joining us. Before we begin, I'd like to remind listeners that today's discussion includes forward-looking statements, including statements regarding our regulatory plans, potential NDA submission, and approval timing, commercialization, expectations, cash runway, capital structure, and the potential therapeutic benefit in future developments of Sarah Lutonit. These statements are subject to risks and uncertainties that could cause actual results to differ materially. Please refer to our SEC filings in today's press release for discussions of these risks. We undertake no obligation to update these forward-looking statements except as required by law. We're very excited this morning to have on our call today Fahim Hasning, Karen Peterson, Dr. Rob Resigno. Additionally, we have Dr. Jean-Marie Bruy, Dr. Rainer Zimmerman, Dr. Megan Flynn, Dr. Robin Osterhout, and Bob Smith, our chief commercial officer, to speak about our exciting results this morning. Today, we plan to cover three topics. First, a regulatory update, including our Type B pre-NDA meeting. Secondly, we will discuss results from our ProSERA CT-FRI sub-study. and third, an update on our capital structure, including the convertible note exchange. Our financial results for the first quarter of 2026 are included in this press release, and I will come back to briefly discuss these at the end of the call. With that overview, let me hand it over to Taheem to discuss our recent progress. Taheem?

Yeah, thanks. Thanks, Brian, and good morning, everybody. In February, we reported top-line results from ProSERA. Our Phase III study of serolutinib in patients with PAH. At high level, Procera showed a clinically meaningful placebo-adjusted improvement of 13.3 meters in six-minute walk distance at week 24, with patients on serolutinib improving 28.2 meters from baseline versus 13.5 meters on placebo and a p-value of 0.032. That p-value met the traditional 0.05 threshold for statistical significance but it did not meet the pre-specified 0.025 alpha threshold. At the same time, all four key secondary endpoints favored serolutinib over placebo, and we saw a stronger effect in the pre-specified risk-enriched subgroup. Taken together, we believe the totality of the ProSERA data supports a real and clinically meaningful treatment signal. Now, since the ProSERA top line readout, we've been focused on three work streams in parallel. First, we engaged with the FDA on the path forward for serolutinib. That process advanced from the previously disclosed type C meeting to a type B pre-NDA meeting, which is the most formal pre-submission meeting type. The meeting has been confirmed as in-person, and the briefing book has been submitted. Karen will cover that in more detail shortly. Second, we completed the analysis of the pre-specified CT-FRI substudy, which enrolled 162 patients with 125 evaluable paired scans at week 24. Those results showed multi-compartment structural reverse remodeling across arterial, venous, fibrosis-like, and vascular complexity parameters. You will hear the full data shortly in the FRI section of the call. we moved quickly on capital stewardship. We recognized immediately that while the top-line results was clinically meaningful, it also created uncertainty, and we needed to act decisively to protect the company's financial position and preserve our ability to get serolutinib to patients. That included a significant reduction in force affecting approximately half the company, a sharp reduction in operating expenses as Procera winds down, and the pause of other development activities and broader cost containment across the organization. At the same time, we engaged constructively with our convertible note holders to address the upcoming 2027 maturity. Brian will cover the outcome of that process later in the call. All of these actions were taken for the same reason, to make sure this company has the runway, the focus, and the resources to pursue an NDA submission and ultimately get an approved treatment to patients with PAH. Our conviction in serolutinib has increased since the top line readout, not decreased. That conviction is based on a totality of evidence, consistent drug arm performance in ProSERA, confirmatory data from Tori, multi-compartment mechanistic evidence from the CT-FRI and the regulatory path we're advancing with the FDA. This is a first-in-class inhaled tyrosine kinase inhibitor for a rare and fatal disease with high unmet need, and we believe we owe it to patients to pursue this path with discipline and urgency. I'll turn it over to Karen to discuss our regulatory interactions and next steps. Karen?