8/9/2021

speaker
Operator
Conference Call Operator

and thank you for standing by. Welcome to the Gossamer Bio Q2 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, just press star 0. And I would now like to turn the call over to your first speaker, Brian Jurado, Chief Financial Officer. You may begin your conference.

speaker
Brian Jurado
Chief Financial Officer

Thank you, Operator, and thank you all for joining us this afternoon. I'm joined on today's call by Gossamer Biles Chairman, Co-Founder and Chief Executive Officer, Christine Hadley, Richard Aranda, Gossamer Biles Chief Technical Officer, as well as Laura Carter, Gossamer Biles Chief Scientific Officer. Earlier this afternoon, Gossamer Bio issued a press release announcing its financial results for the second quarter ended June 30, 2021, in addition to providing a corporate update. Please note that certain information discussed on the 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 the risks and uncertainties associated with the company's business. These forward-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 consensual information that may be accurate for only a limited period of time. Our ability to meet our guidance, especially that related to timely initiation and completion of our clinical studies, in addition to our ability to release results from our clinical trial in a timely manner, may be adversely affected by the ongoing COVID-19 pandemic. Gossamer Bio takes no obligation to revise or update any forward-looking statements or events or circumstances after the date of this conference call. Now I'd like to turn the call over to Padim.

speaker
Fahim Rahmani
Call Moderator

Thanks, Brian, and good afternoon to everyone who's joining us on today's call. We appreciate you tuning into this earnings and update call to discuss our efforts at Gossamer and the efforts that we've been making to develop new medicines to meet unmet needs across a variety of diseases. I've branded 2021 as a year of execution for Gossamer, and our team has worked tirelessly to set the stage for 2022 to be a transformative year for our portfolio. I'm going to turn the call over to Richard in a minute to give you a more detailed update. But to start, the highlights are that we're on track to have two phase two data readouts for our two lead clinical programs, serolutinib and GB004, in the first half of 2022, of course, subject to further developments in the pandemic. Much of the focus on the call today will be on serolutinib. So I'm going to start with GB004 as I view this as an equally exciting part of Gossamer's portfolio. The SHIFT-UC study of GB004 is enrolling 195 patients with active ulcerative colitis despite treatment with 5-ASA and evaluating the induction of clinical remission at 12 weeks as its primary end point. We believe that GB004 has a potential to disrupt the treatment paradigm in UC and Crohn's disease as an oral, non-immunosuppressive product candidate that's meant to induce mucosal healing in patients with inflammatory bowel disease. We're looking forward to the results of the SHIFT-UC study in 2022. Now, moving on to serolutinib. The TORI study is enrolling 80 patients with pulmonary arterial hypertension and evaluating change in PVR at 24 weeks at its primary endpoint. Serolutinib has the potential to be a disease-modifying treatment for PAA patients for whom the only currently approved treatments are vasodilatory and do not affect the underlying disease pathogenesis. And we're also excited today to give you a glimpse of the open label data generated with serolutinib. As a reminder, serolutinib is an inhaled PDGFR C-kit and CSF1R kinase inhibitor, which is currently enrolling a phase two study in PAH patients. Now the pandemic allowed just two patients to complete the open label extension. So while the data set is limited, these case studies give us greater confidence that we're on track As we look forward to the readout next year from our 80 patient phase two Tory study. Now, without any further ado, I'd like to hand it over to Dr. Richard Aranda, Gossamer Bio's chief medical officer, who will provide this update on the Sarah Lutna program, as well as an update on our other lead clinical program, GB004. Richard?

Disclaimer

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