Gossamer Bio, Inc.

Good afternoon. Today's conference call is scheduled to begin momentarily. Please continue to stand by. Thank you for patience. Once again, today's conference call is scheduled to begin momentarily. Please continue to stand by. Thank you for patience. Thank you. Thank you. Good day and thank you for standing by. 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 keypad. And if you require any further assistance, you may press star 0. Without further ado, I would like to welcome your first speaker for today, Mr. Brian Dorado, sir, the floor is yours.

Thank you, operator, and thank you all for joining us this afternoon. I am joined on today's call by Gossamer's co-founder, chairman, and chief executive officer, Fahim Hasning, Gossamer's chief medical officer, Dr. Richard Aranda, and Gossamer's chief scientific officer, Dr. Laura Carter. Earlier today, Gossamer issued a press release announcing its year-end 2021 financial results and provided a corporate update. Please note that certain information discussed on the call is covered under the safe harbor vision 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 that are 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 substance violence. This conference call also contains time-sensitive information that may be accurate only for a limited period of time. Our ability to meet our guidance, especially that related to timely initiation and completion of clinical studies, in addition to our ability to release results from our clinical trials in a timely manner, may be adversely affected by the ongoing COVID-19 pandemic. Gossamer Bio undertakes 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 Dineen.

Thank you, Brian, and thanks to everyone for joining us on this afternoon's call. 2021 was the year of execution for the Gossamer team. Despite the challenges that the preceding two years have provided, we at Gossamer are excited and energized to enter 2022 with two upcoming proof-of-concept Phase II readouts in ulcerative colitis and pulmonary arterial hypertension. Now, while these product candidates, serolutinib and GB004, target different indications utilizing different approaches, we view them both alike in the sense that they're using novel mechanisms to target populations that continue to be underserved. And if approved, we believe both molecules hold treatment paradigm shifting potential. First, let's start with GB004. The Phase II SHIFT-UC study is on track to read out Week 12 primary endpoint top-line results early in the second quarter of this year. And as a quick reminder, the SHIFT-UC study is a randomized, double-blind, placebo-controlled global clinical trial studying GB004 in patients with active mild to moderate UC despite treatment with 5-ASA therapy. Patients were randomized in a one-to-one-to-one ratio between two doses of GB004 in tablet form and placebo. The 12-week primary endpoint of this trial is clinical remission, and secondary endpoints include clinical response, histological remission, endoscopic improvement, and mucosal healing. Relevant safety and exploratory endpoints are also being assessed during the clinical trials. The GP004 is distinct and may have a differentiated profile from the immunomodulatory or immunosuppressive mechanisms of approved IBD medications and those in late-stage development. GP004 is designed to be gut-targeted with higher intestinal exposure than systemic exposure, and clinical and preclinical data generated to date support this thesis. By reducing local inflammation and potentially restoring intestinal epithelial barrier function and restitution through GbO4's gut-targeted nature and preferential stabilization of HIF-1-alpha, we believe GbO4 could improve outcomes for IBD patients. We believe this mechanism has potential as a standalone therapeutic as well as a combination therapy with other therapeutic mechanisms in IBD. Now, in addition to the week 12 primary endpoint coming early in the second quarter, in the fourth quarter of this year, the SHIFT-UC trial is also expected to read out week 36 treat-through endpoints in the fourth quarter. Now, as some of you may know, we had a number of our sites and patients within the ongoing phase two SHIFT-UC study in Ukraine and Russia. First, and most importantly, our hearts go out to our Ukrainian patients, caregivers, investigators, study coordinators, and, of course, the Ukrainian people as a whole. Above all else, we hope for their health and safety in this horrific situation. In terms of impact to our ongoing trials, Gossamer Bio's clinical operations team has been vigilant and proactive throughout the escalation of tensions and the tragic breakout of hostilities. we anticipate no impact on data to our 12-week primary endpoint. Understandably, communication into Ukraine has been challenging, and we're continuing to monitor for impacts to our 36-week data set. Moving on to serolutinib, also known as GB002, Gossamer continues to enroll patients in its ongoing Phase II TORI study in patients with functional Class II and III PAH patients. As you may recall, the wave of COVID-19 related to the Delta variant in the late summer and fall of 2021 raised barriers to enrollment. But we're pleased to say that at this point, the wave of COVID-19 related to Omicron variant has not significantly impacted patient enrollment. Today, we're able to reiterate our current guidance that we expect to read out top-line data from the ongoing Torrey study in the second half of this year. of course, barring any further developments in the ongoing COVID-19 viral pandemic. Now, once patients complete the blinded 24-week study period as part of the Torrey study, they are granted the option of enrolling into an open-label extension trial. This extension trial should allow us to generate valuable and elucidating long-term data in patients. To date, we continue to see a very high percentage of patients who have completed the 24-week study period, elect to continue on to the open-label extension, similar to the IMPRESS study of imatinib and the Pulsar study of cetatarset. If you recall, the IMPRESS study was hindered by a very high discontinuation rate due to adverse events, with roughly one-third of patients in the imatinib arm dropping out prior to the 24-week primary endpoint. The majority of these dropouts in the IMPRESS study occurred in the first eight weeks. We've been pleased to see that, to date, the blinded discontinuation rate in the TORI study has been more comparable to the more manageable discontinuation rate observed in the PULSAR study of cetatercept. Now, moving on from serolutinib, our CNS penetrant BTK inhibitor, GB5121, is expected to enter a global phase 1B slash 2 clinical study in PCNSL or CNS lymphoma patients the first half of this year. We previously announced on our prior earnings call that GB5121 had entered a clinical trial in healthy volunteers outside of the U.S. Since then, in the fourth quarter of 2021, we're happy to announce today that our IND application has been submitted with and accepted by the U.S. FDA. And with that, I'll hand it over to our CFO and COO, Brian Jurado, for a final update. Brian? Thank you, Fahim.