Gossamer Bio, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Gossamer Bio Q4 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. I would now like to hand the conference over to your speaker today, Brian Jurado. Please go ahead, sir.

Thank you, operator, and thank you all for joining us this morning. I am joined on today's call by Gossamer's co-founder, chairman, executive officer, Faheem Hasnain, and Gossamer's senior vice president of clinical development, Richard Aranda. Earlier this morning, Gossamer Bio issued a press release announcing it's year-end 2020 financial results and provided a corporate update. Please note that certain information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, Gossamer management will be making forward-looking statements. Actual results may differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the statements contained in Gossamer's news releases, SEC filings, including in the annual report on Form 10-K and subsequent filings. This conference call also contains time-sensitive information that may be accurate for only a limited period of time. Gossamer Bio takes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. Now I'd like to turn the call over to Saheem. Saheem?

Thank you, Brian, and thanks to all of you for joining us on the call this morning. And today we'll provide you an update on Gossamer's four clinical product candidates. And then Brian will walk us through the 2020 year end financial results. We as a team have made great progress to date, and we look forward to continuing that progress in 2021, which we view as a year of intensely focused execution that will of course lead us into 2022, where we will share our phase two top line data on our two key parallel proof of concept trials for our co-lead product candidates, serolutinib, also known as GB002 for the treatment of PAH, and GB004 for the treatment of inflammatory bowel disease. Now, despite the fact that they're obviously treating different indications, both programs share key characteristics that we find very attractive. Both product candidates are targeting populations of severe unmet need using novel, as of yet, unapproved mechanisms to address the underlying pathophysiology of disease. We believe both assets could be transformative to the current treatment paradigm, as both serolutinib and GV004 have, to date, been generally well-tolerated in healthy volunteers and patients in indications where therapies don't always have clean safety profiles. So let's start with serolutinib for the treatment of PAH. Serolutinib is an inhaled inhibitor of PDGF, CSF1R, and CKIT, and it's currently enrolled in PAH patients in the ongoing Phase II TORI study. As a reminder, we expect to enroll approximately 80 functional Class II and III PAH patients who will remain on background therapy, including triple therapy. The primary endpoint of the TORI study is change from baseline in PBR at week 24 with a key secondary endpoint of change from baseline at week 24 in six-minute walk distance, although the trial is not powered for statistical significance in that six-minute walk distance. The top-line results from the TORI trial are expected in the first half of 2022, subject, of course, to developments in the ongoing COVID-19 pandemic. And I'd like to encourage anyone who missed our KOL-led Sarah Lutnib Investor Day in December to go to the events page on the investor section of our website at gossamerbio.com, where a recording of the event is available. Now, our other co-lead product candidate, GB004, is an oral HIF-1-alpha stabilizer for the treatment of IBD. GB004 is enrolling its phase two trial, what we call the SHIFT-UC study, for the treatment of ulcerative colitis. Now, remember, we expect to enroll approximately 195 patients with mild to moderate UC who will remain on stable background 5-ASA therapy throughout the study. The primary endpoint, the SHIFT-UC study, is clinical remission at week 12, with secondary endpoints including clinical response, histological remission, endoscopic improvement, and mucosal healing. The study will also evaluate these endpoints at week 36. Top line 12-week results from the SHIFT-UC trial are expected in the first half of 2022, again, subject to the developments of the ongoing COVID-19 pandemic. And a recording of last week's KOL-led GB004 Investor Day is also available on the events page of the investor section of our website at gossamerbio.com. And I encourage you also to watch the event recording as well as the Sarah Lutnib event if you haven't already. Now, in addition to Sarah Lutnib and GB004, Gossamer is also advancing GB1275. which is an oral CD11B modulator through a phase 1-2 trial for the treatment of advanced hard-to-treat solid tumors. We're currently enrolling up to 40 patients in a phase 1 expansion cohort, studying the recommended phase 2 dose in patients with gastric or esophageal cancer that have progressed after initial response to anti-PD-1 therapy, and in patients with advanced microsatellite-stable colorectal cancer, We expect to announce further data from this ongoing trial in 2021 once it becomes available. Now, moving on to our final clinical product candidate, GB001, which is an oral DP2 antagonist for the treatment of asthma. As you may remember, we previously read out top-line results from the Phase 2B LIDA study in the fourth quarter of this past year. After discussing those results with both the FDA and the EMA, we do believe that there exists a viable clinical development path for GB001 or our related DP2 antagonist backup molecule for the treatment of asthma. Now, that being said, I want to make it crystal clear that Gossamer will not be advancing a DP2 antagonist, either GB001 or its backup in further clinical trials without a partner. We believe an oral DP2 antagonist can benefit patients, but we're currently focused on the successful execution of our ongoing phase two trials. With that, I will hand it over to our Chief Financial Officer, Brian Jurado, for a financial update. Brian? Thank you, Fahim.