Gossamer Bio, Inc.

Good day and thank you for standing by. Welcome to the Gossamer Bio Q3 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. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Mr. Brian Truetto, Financial and Chief Operating Officer. Thank you. Please go ahead.

Thank you, Operator, and thank you all for joining us this afternoon. I am joined on today's call by Gossamer Bios Chairman, Co-Founder and Chief Executive Officer Faheem Hasnain, Laura Carter, Gossamer Bios Chief Scientific Officer, and Richard Aranda, Gossamer Bios Chief Medical Officer. Earlier this afternoon, Gossamer Bio issued a press release announcing its financial results for the third quarter ended September 3, 2021, in addition to providing a corporate update. Please note that certain information discussed on this call today is covered under the safe harbor provision 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 four looking statements are qualified by the statements contained in Gossamer's news releases and 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 only for a limited period of time. Our ability to meet our guidance, especially that related to the 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 day of this conference call. Now, I'd like to turn the call over to Fahim. Fahim?

Thanks, Brian. And thank you all for joining us today on Gossamer Bios' third quarter earnings and update call. At the end of today's call, we'll conduct a question and answer session. But first, we will discuss our inhaled kinase inhibitor for the treatment of pulmonary arterial hypertension, serolutinib. In the press release we issued earlier today, we shifted our guidance for the top-line data readout for the Torrey Phase II study of serolutinib to the second half of 2022. And as I'm sure all of you are aware, the COVID-19 pandemic has created unprecedented challenges in conducting clinical trials, including a shortage of medical professionals. And we believe that these challenges, given the nature of COVID, were more impactful for our clinical trials in the arenas of pulmonary and critical care. We started screening patients for the Torrey study in December of 2020. Prior to the full effect of the Delta variant in the U.S. and Western Europe, we experienced a meaningful uptake in screening and enrollment this spring and through the midsummer, and we leveraged many of our learnings with COVID from our completed Phase 1b trial. At the time of our second quarter call on August 7th, we were confident on meeting expected timelines, especially with the uptake in both screening and enrollment at U.S.-based sites. However, With the emergence of the Delta variant, many of our investigators and nurses were called back into COVID ICU wards in mid-August and September. Further lockdowns on national, regional, and municipal levels created an additional obstacle, and enrollment in many locations throughout the Western world essentially ground to a halt. Moreover, we also experienced competition from COVID-related trials, specifically pediatric and booster vaccine work, as well as from some of the COVID antibody and therapeutic trials. I'm pleased to say now that the Delta appears to be passing, we're seeing increased engagement with sites and investigators as they've gone back to their non-COVID research and clinical programs. And we're actively working to translate that into screenings and enrollment. Remember, we first encountered COVID-based enrollment obstacles in the Phase 1B study. While getting patients enrolled remains an issue, once on study, we have designed the study protocol with COVID in mind, and we've incorporated measures to keep patients on study once they're enrolled. Despite COVID, of those patients that have already completed the 24-week TORI Phase 2, all have enrolled into the OLE. With nearly all of our 70 plus sites online and engaged, we're confident that we can continue to navigate these challenges to complete enrollment in the first half of next year and read out top line data in the second half of 2022. Now, moving on to GB004. We are extremely pleased today to announce that last month we completed an enrollment for the SHIFT-UC Phase 2 study in mild to moderate ulcerative colitis patients with active disease. We were able to enroll this group of patients despite the pandemic for a number of reasons. GB004's mechanism of action is distinct from systemic immunosuppressants, and with COVID a real concern for investigators and patients alike, GB004 became an attractive option for those institutions focused on clinical trials in inflammatory bowel disease. We believe this also speaks well to the target positioning of GB004 in an evolving ulcerative colitis commercial landscape. Patients with severe UC are inundated with treatment options that are lacking from a safety and tolerability perspective. But mild to moderate UC patients who fail five ASAs are hesitant to make the jump to biologics and immunosuppressive therapies. This dynamic has buttressed GB004 trial enrollment throughout COVID, and we believe it bodes well for the commercial potential of the molecule. Additionally, the contributions from many capable team members, including from the legacy Receptus of Zanamon team, were instrumental in building a global clinical trial infrastructure, leveraging longstanding relationships, and positioning this trial for successful enrollment. The primary endpoint of this trial is clinical remission after 12 weeks. Once all patients complete 12 weeks and an additional month of safety monitoring, we expect to announce top-line results early in the second quarter of 2022. After the 12-week primary endpoint, patients will stay on randomized therapy for an additional 24 weeks. After completion of 36 weeks of randomized therapy, we expect to announce the results of the 36-week treat-through endpoint in the fourth quarter of 2022. Following completion of the trial, patients will be presented with the option to enroll in our open-label extension study, where we hope to generate longer-term data. Now, before I ask Brian to run through the financial results for the quarter, I wanted to remind listeners today that Gossamer recently unveiled its next clinical stage product candidates, a pair of CNS penetrant BTK inhibitors, known as GB5121 and GB7208. These candidates are the product of intensive behind-the-scenes internal development work. We believe that these molecules have differentiated properties, including superior brain penetration, that position the candidates to treat neuroinflammatory and neurodegenerative conditions in oncology and autoimmune disease. including primary CNS lymphoma and multiple sclerosis. And we're also pleased today to announce that we have dosed our first subject with 5121, GB5121, in a phase 1 trial in Healthy Volunteers this month. We expect to initiate a potentially registrational phase 1B-2 trial in the first half of next year. GB7208 is expected to enter a first-in-human clinical trial in the second half of next year. Please visit our website at gossamerbio.com to see a recent Investor Day presentation that details both of these candidates and our development plans. I'll now turn it back to Brian.