Gossamer Bio, Inc.

Ladies and gentlemen, and welcome to the Gossamer Bio second quarter 2019 earnings conference call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session, and instructions will be given at that time. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. As a reminder, this conference is being recorded. I would now like to turn the conference over to Bryan Giraudo, Chief Financial Officer. Mr. Giraudo, you may begin.

Thank you, operator, and thank you all for joining us this afternoon. With me on today's call are Gossamer Bio's co-founder and chief executive officer, Dr. Sheila Gujarati, as well as Gossamer's chief medical officer, Dr. Jacob Dupont. Earlier this afternoon, Gossamer Bio issued a press release announcing its financial results for the second quarter ended June 3, 2019, and provided a corporate update. Please note that certain information discussed on the call today is covered under the state-powered 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 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 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 it over to Sheila. Sheila?

Thank you, Bryan, and good afternoon to everyone joining us in today's call. Here at Gossamer, we are focused on discovering, acquiring, developing, and commercializing therapeutics in the disease areas of immunology, inflammation, and oncology. Our goal is to be an industry leader in each of these therapeutic areas and to enhance and extend the lives of patients suffering from such diseases. We are working to achieve this vision by focusing on building a diversified immunology portfolio with multiple meaningful shots on goal. To that end, over the past few months, the Gossamer team has delivered on a number of critical clinical development milestones along our journey towards benefiting patients. On today's call, I'm going to walk you through the updates and milestones achieved for three of our four clinical stage programs, Before handing it over to our Chief Medical Officer, Jacob Dupont, for a discussion of our newest clinical asset, GB1275. Bryan will then discuss Gostomer's financial updates, following which I will provide a few closing remarks. Let us begin with our most advanced clinical stage product candidate, GB001, an oral DP2 antagonist, which we are developing for Ethanophilic Asthma and other allergic conditions, including chronic rhinocytosis, both with and without nasal polyps, and chronic spontaneous urticaria. As you may recall, our Phase IIb trial in moderate to severe Ethanophilic Asthma, known as the LIDO study, began in rolling patients in October of 2018. LEADER is a global Phase IIb study testing one daily dosing regimen of GB001 over a 24-week treatment period. All patients will remain on background therapy throughout the study, and the primary endpoint is a composite measure known as asthma worsening. We are happy to reaffirm that enrollment in the study remains on track to trigger an interim analysis in the first half of 2020. After this interim analysis, we expect full top-line Phase 2B results to read out in the second half of 2020. On our last call, We announced the first patient was screened for our Phase II proof-of-concept study of GV001 and chronic rhinocytosis, known as the TITAN study. Since that update, we have begun actively enrolling patients in TITAN, which is recruiting patients with chronic rhinocytosis, both with and without nasal polyps. These indications have significant overlap with the asthma population and represent areas of high unmet need, as there are few effective treatment options for patients failing to respond to intranasal steroids. We plan to enroll approximately 100 patients in Titan. The study is designed to measure the effect of GV001 on the Sino-nasal outcome test, or SNOT22 score, after 16 weeks of treatment, in patients who are refractory to intranasal steroids. The SNOT22 endpoint has relevance for both parties with and without nasal polyps. We also plan on assessing polyp-specific endpoints, such as a nasal polyp score and a subset of patients with polyps as a key secondary endpoint. Based on current involvement trends, we are on track to read out top-line data for this proof-of-concept Phase II study in the second half of 2020. In regards to chronic spontaneous urticaria, or CSU, an indication with endurance of existing approved therapies, we remain excited about GV001's potential and we look forward to initiating a Phase II proof-of-concept study and CSU later this year. In the nearer term, we have a poster presentation at the American Rhinologic Society Annual Meeting in New Orleans this September, and we have a poster discussion at the European Vegetarian Society International Congress in Madrid this October. Please be on the lookout for those. To close on GB001, we are very optimistic about the significant potential that this once-daily oral GP2 antagonist holds across multiple allergic disease areas with high unmet needs, and we look forward to reporting several Phase II top-line readouts in 2020. Now let's move on to our second clinical stage product candidate, GB002. GP002 is an inhaled PDGFR inhibitor that our team is developing for the treatment of pulmonary arterial hypertension, also known as PAH. PAH is a devastating, progressive, rare disease with high unmet medical needs and limited classes of approved therapies. GP002 has the potential to be the first drug in a new therapeutic class, and we believe it could provide disease-modifying effects to patients. The FDA and the EMA have granted GB002 orphan drug designation for the treatment of patients with PAH. Earlier this year, we completed our Phase 1 safety studies of GB002 in normal healthy volunteers with no serious adverse events observed. I am pleased to report that we have activated sites for our Phase 1B trial in PAH patients and expect initial patient enrollment to occur in the third quarter of this year. This Phase B is an exploratory translational study and our goal is to generate target engagement and biomarker data and to assess the initial safety and tolerability profile in CAH patients. We expect a readout from the Phase 1B trial in the first half of 2020. Additionally, we continue to have discussions with health authorities about our registration-directed Phase 2-3 trial and anticipate initiating the study by the end of this year. Moreover, we are excited about presenting more of our preclinical data on GB002 at upcoming medical conferences, including the American Heart Association 2019 scientific sessions in November, which just notified us of the acceptance of two abstracts, one as an oral presentation and one as a poster presentation. Next, we will discuss GB004. and oral hip 1 alpha stabilizer for the treatment of inflammatory bowel disease, including ulcerative colitis or UC. GP004 is a gut-targeted polyhydroxylase inhibitor designed to preferentially stabilize hip 1 alpha, a transcription factor involved in the body's protective response to low oxygen levels. We believe that this preferential stabilization of HIP-1-alpha will lead to the healing of the gut lesions associated with inflammatory bowel disease and potentially other diseases of the bowel. On our last call, we announced the commencement of enrollment in our Phase 1 retrial of GB004 in patients with active mild to moderate UC in which we are dosing patients for four weeks. The study is designed to demonstrate proof of mechanism in UC patients based on target engagement, changes in gene expression, epithelial barrier restoration, and potentially UC symptom improvement. Enrollment is going very well and we expect to report initial top line results from the Phase 1b in the first half of 2020. Now I will hand it over to Gossamer Bio's Chief Medical Officer, Dr. Jacob DuPont, who will discuss our latest entrant into the clinic and Gossamer Bio's first clinical stage oncology asset, GB1275.