Gossamer Bio, Inc.

Thank you. Ladies and gentlemen, the conference is scheduled to start in a moment. Until that time, your lines will be placed on hold. Please continue to stand by. We thank you for your patience. Ladies and gentlemen, thank you for standing by and welcome to the Gossamer Bio Q3 2020 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 moderator today, Mr. Brian Jurado, Chief Financial Officer. Thank you. Please go ahead, sir.

Thank you, Operator, and thank you all for joining us this afternoon. I am joined on today's call by Gossamer Bio's Co-Founder and Chief Executive Officer, Dr. Sheila Gujarati, as well as our Chief Scientific Officer, Dr. Louisa Salter-Sidd. Earlier this afternoon, Gossamer Bio issued a press release announcing its financial results for the third quarter ended September 30, 2020, 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 time-sensitive information that may only be accurate 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 date of this conference call. Now I'd like to turn the call over to Sheila. Sheila?

Thank you, Brian, and good afternoon to everyone who is joining us on today's call. We appreciate you taking the time to hear about the progress Gossamer has made. Earlier this afternoon, Gossamer Bio was pleased to announce its financial results from the third quarter 2020, in addition to several updates to the status of our pipeline of clinical product candidates. Gossamer Bio was founded as an innovative research and development engine. to deliver values through the selection and development of a pipeline of multiple independent programs across the therapeutic areas of inflammation, immunology, and oncology. This engine is centered around an experienced team with a history of successful and efficient execution in these closely related therapeutic areas. Each program is backed by rigorous preclinical and clinical work to understand and de-risk the product candidates, focused on areas of high unmet need and a differentiated product profile that would be meaningful for patients. We are pleased to be advancing two independent molecules targeting two different indications into Phase II trials. We are also excited to discuss new clinical data from our immuno-oncology candidate, GB1275, as it continues to progress through its Phase I-II trial in solid tumors. All told, development progress from multiple candidates is a manifestation of Gossamer's purpose, the continual and simultaneous advancement of multiple high-potential programs through the execution of the proper experiments to create value for shareholders. First, I will briefly review the status of GB001, our once-daily oral DP2 antagonist for the treatment of moderate to severe asthma. In October, we read out the top line results of our Phase 2B LIDA study. While the primary endpoint of asthma worsening was not met, GB001 did demonstrate a consistent reduction of 32 to 35% in the proportion of patients exhibiting asthma worsening across all three active drug arms as compared to placebo. And in the key secondary endpoint of time-to-first asthma worsening, we saw statistically significant improvements in both the 20 milligram and the 60 milligram dose groups as compared to placebo. We are currently in the progress of engaging with global regulatory authorities about these results and the path forward. We hope to have clarity from these discussions in the first half of next year, which will help inform potential partnerships and strategic alternatives. Since the end of the third quarter, we have activated two value-deriving proof-of-concept Phase II clinical trials for our GB002 and GB004 programs, which I will touch upon before walking through the recent clinical data reported this week at SISTI from our oncology candidate, GB1275. After that, Brian will provide a financial update. GB002 is an inhaled PDGFR receptor inhibitor for the treatment of pulmonary arterial hypertension, or PAH. GB002 was designed to improve upon prior success observed with kinase inhibition in PAH by delivering a tyrosine kinase inhibitor with an optimized selectivity and potency profile directly to the site of disease by a convenient dry powder inhaler. GB002 is being studied on top of vasodilators with the hope of delivering a new standard of care that reverses pulmonary vascular remodeling and further improves patient outcomes. Our ongoing two-week Phase 1B study is meant to bridge the safety, PK, and PD results we saw in our Phase 1 studies in healthy volunteers to an initial experience in PH patients. While the two-week portion of the study is too short to evaluate changes in clinical endpoints, we have gathered important information on target engagement and biomarkers. These patients also have the option to roll onto a six-month open-label extension. We look forward to sharing the two-week data before year end at a GB002-focused investor event in December. As a reminder, this study's conduct was interrupted earlier this year by the COVID-19 pandemic. And now that the trial has restarted, we have enrolled new patients onto the study. We believe this Phase 1B impatience helped inform us how a PH trial needs to be conducted during the COVID pandemic. And while unanticipated, the lessons learned here in terms of protocol adjustments, operations, logistics, as well as the investigator and patient experience, are critical to moving this program forward in PAH. We are also excited to announce that we have activated multiple sites for our Phase II TORI study. We expect to begin enrollment of this trial in the fourth quarter. The TORI Phase II study is a 24-week, double-blind, placebo-controlled, multi-center clinical study to evaluate the efficacy and safety of GB002 in functional class II and III pH patients. This is an 80-patient study, and patients will be randomized evenly between drug and placebo. The primary endpoint is change in pulmonary vascular resistance from baseline at week 24, and the key secondary endpoint for this trial will be change in six-minute walk test distance. We expect to be able to read offline data from the Phase II TORI study in the first half of 2022. subject to further developments in the COVID-19 pandemic. We are working closely with sites, investigators, and study coordinators surrounding the obstacles posed by COVID-19 with a focus on patient health, and we believe we have put in place protocols and procedures to help mitigate that risk. In response to the inbound interest we have received on the GB002 program from investors, clinicians, and patient advocacy groups over the past few months, We will host a GB002 PAH focused webinar in December. During the call, we plan to discuss rationale for GB002 and PAH, initial results from our Phase 1b study, and give additional details on our Phase 2 study design, in addition to making some of our key external advisors available for Q&A. We hope you will join us on this call to learn more about the GB002 program. Please be on the lookout for details surrounding this virtual event in the coming weeks. Next, we will discuss our oral hip analysis stabilizer, GB004, which is being developed for the treatment of inflammatory bowel disease. As a reminder, GB004 is an oral gut targeted therapy with a unique mechanism of action that is intended to address the high disease burden and impaired quality of life in patients with IBD. Unlike traditional anti-inflammatory approaches to IBD, GB004 is believed to promote the healing of the mucosa, to achieve sustainable histologic, endoscopic, and clinical remission. GB004 has the potential to deliver meaningful patient benefit, both as a monotherapy and in combination with standard of care in patients across the disease continuum. We are so pleased to announce that we have begun dosing patients in a GB004 SHIFT-UC Phase II study in patients with active ulcerative colitis. The SHIFT-UC Phase II study is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, PK, and PD of GB004 in adult subjects with mild to moderate active ulcerative colitis. We expect to enroll about 195 UC patients who will be randomized evenly across two-dose groups and placebo. The primary endpoint for this trial is proportion of patients with clinical remission at week 12. Secondary endpoints include proportion of patients at week 12 with clinical response, histologic remission, endoscopic improvement, and mucosal healing. Patients will remain on background therapy, including 5AA phase and steroids, throughout the trial. We expect to be able to read out top line data from the phase 2 SHIFT-UC study in the first half of 2022, subject to further developments in the COVID-19 viral pandemic. In line with what I mentioned previously regarding the Torrey study in PH, we are working closely with SHIFT-UC sites to mitigate potential COVID-19-related disruption. Also, we believe there is a possibility that GB004's non-immunosuppressive mechanism may turn out to be a recruiting advantage in the recruitment of UC patients as compared to immunosuppressive therapies. We're commencing this Phase II induction study in UC after having completed a four-week Phase Ib trial in patients with active mild to moderate disease. In October at UEG Virtual Week 2020, Dr. Bill Sanborn of the University of California San Diego presented these data following Gossamer's top-line announcement in May of this year. We received a great deal of interest and positive feedback from KOLs and investigators following Dr. Sanborn's presentation, which is available on the posters and publication section of our website that is enabling us to hit the ground running with our Phase II trial. And finally, we will turn to GB1275, our oral CD11B modulator being developed for the treatment of solid tumors. We have a couple of updates on our Phase I-II Keynote A36 trial being shared at SISTI this week. Dr. Johanna Bendel is presenting poster number 388, which details some of the GB1275 clinical results from the ongoing dose escalation portion of Keynote A36, from both monotherapy and in combination with pembrolizumab. Dr. Wells Messerschmidt is presenting poster number 389, which dives into the relevant clinical biomarker data, which is also from this ongoing Phase I-II study in advanced solid tumors. Enrollment in the dose escalation phase continues, as no dose-limiting toxicity has been observed. Oral GB1275 has now been used to treat 40 patients with doses up to 1,200 milligrams twice daily. Safety data suggests that GB1275 both alone and in combination with pembrolizumab is well-tolerated. Despite being studied in tumor types that are known to be less responsive to checkpoint inhibitors, GB1275 has generated encouraging clinical and biologic activity especially in dose cohorts equal to or greater than 800 milligrams BID. In terms of clinical activity, 12 patients had an initial resist assessment of stable disease with a median duration of treatment of 102.5 days. Among those 12 patients, prolonged stable disease, stable disease greater than 84 days, was noted in seven patients who had microsatellite-stable colorectal metastatic carotid-persistent prostate cancer, triple negative breast cancer, and gastric cancer. Three of these patients received monotherapy in regimen A, and four of these patients received combination therapy in regimen B. Importantly, five of the seven involved doses greater than or equal to 800 mg BID, suggesting increased clinical activity at higher doses. Staple disease was also observed in two of the combination therapy patients who had previously been treated and progressed for the checkpoint inhibitor. We have seen one confirmed partial response in a patient with microsatellite-stable colorectal cancer who received 800 milligrams of GB1275 BID in combination with pembrolizumab. That patient had previously received five lines of therapy and is continuing on steady treatment. Published preclinical work suggests that GB1275 works by disrupting immunosuppressive myeloid cell biology. which allows for more T-cell infiltration and activation in tumors, potentially converting the tumor microenvironment to an inflamed phenotype. Our early biomarker findings support these aspects of GB1275's mechanism of action. Protein and gene signatures in blood show changes consistent with reduced myeloid-derived suppressor cells, which correlates with dose and pembrolizumab combinations. Myeloid-derived suppressor cells also decrease in dose-dependent manner after treatment with GB1275 or in combination with pembrolizumab. An increase in tumor-infiltrating T lymphocytes or TILs is observed in serial tumor biopsies following both the GB1275 monotherapy regimen as well as the combination therapy with pembrolizumab. CD8-positive T cells also increase with combination treatment. We next plan to further characterize GB1275 in an expansion cohort of up to 40 patients evaluating the recommended Phase II dose of GB1275 in combination with pembrolizumab. We will continue to report out clinical data from this ongoing trial in 2021. Please feel free to view these posters in their entirety on our website. The presentations from Drs. Bendel and Messer-Smith can be accessed on the SISI website as part of the SISI virtual conference. With that, I will hand it over to Gossamer Bios, Chief Financial Officer, Brian Jurado for a financial update. Brian?