Gossamer Bio, Inc.

Good afternoon, and welcome to the Gossamer Bio third quarter 2019 earnings call. Today's call will feature updates from Gossamer Bio's management team, followed by a question and answer session. I will now turn the call over to Gossamer Bio's Chief Financial Officer, Bryan Giraudo. Bryan?

Thank you, Operator, and thank you all for joining us this afternoon. I'm joined on today's call by Gossamer Bio's Co-Founder and Chief Executive Officer, Dr. Sheila Giraudo. As well as Gossamer's Chief Medical Officer, Dr. Jacob DuPont, and Gossamer's Chief Scientific Officer, Dr. Louisa Salter-Sitt. Earlier this afternoon, Gossamer Bio issued a press release announcing its financial results for the third quarter ended September 30, 2019, and provided 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 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 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 the call over to Sheila. Sheila?

Thank you, Bryan, and good afternoon to everyone joining us on today's call. Since our initial public offering in February of this year, I have emphasized that Gossamer Bio's goal is to be an industry leader in immunology, inflammation, and oncology, and to enhance and extend the lives of patients suffering from such diseases. On today's call, I am excited to further update you on Gossamer's continued progress towards that ambitious goal. I will walk you through the updates and milestones achieved for each of our four clinical stage product candidates, and then Bryan will discuss Gossamer's financial updates, following which I will provide a few closing remarks. We will begin with our most advanced clinical stage product candidate, GB001, an oral DP2 antagonist, which we are developing for eosinophilic asthma and other allergic conditions, including chronic rhinositis, both with and without nasal polyps, and chronic spontaneous urticaria. Gossamer Bio continues to enroll the LIDA study for the treatment of moderate to severe eosinophilic asthma. LIDA is a global Phase IIb study testing GB001 over a 24-week treatment period with patients remaining on background therapy. As a reminder, the LIDA study is enrolling a gene of step 4 and 5 patient population, all of whom must have an easiness of count of at least 250 cells per microliter. LIDA uses reduction in asthma worsening, a composite measure, at 24 weeks as its primary endpoint. The study is on track to trigger an interim analysis in the first half of 2020, once approximately two-thirds of the patients have completed the trial. In the second half of 2020, we expect to read out full top-line phase 2B results for this 400-patient trial. In September, at the European Respiratory Society International Congress in Madrid, we presented a poster further detailing GB001's effects in relation to fractional-scale nitrous oxide, or PHENO, in mild to moderate atopic asthmatics. The data described in the poster suggests that phenol could serve as a useful prognostic marker for treatment response to GB001, in addition to elevated eosinophils, which is the marker we are currently using to enroll the lead of study. The high phenol subpopulation for patients with phenol greater than or equal to 35 parts per billion showed a phenol reduction versus placebo of 13.4 parts per billion. The high pheno subpopulation also showed a mean FEV1 improvement at Phase 28 versus placebo of 207 mL. In our ongoing Phase II LIDA study, we continue to evaluate pheno as a potential biomarker. Late this past week, at the American College of Allergy, Asthma, and Immunology Annual Scientific Meeting in Houston, we presented two posters related to asthma and GB001. The first contained detailed results from the previously discussed proof-of-concept Phase II study run by our partner, Cajun Pharma, and 158 Molotov Moderate Japanese mathematics. The study met its primary endpoint of change in morning peak expiratory flow from baseline versus placebo. Additionally, in the poster, we showed that treatment with 20 milligrams of GB001 led to a 71% reduction in the risk of asthma worsening in the overall population and an 84% reduction in the elevated eosinophil population. These data reinforce our belief that baseline blood eosinophils are a potential useful marker for response to GB001. As part of our ongoing commercial characterization of the asthma market, the second poster from ACAAI details a real-world analysis of the dynamics and prescription trends for biologic usage in asthma. All three of these posters related to GD001 are available on our website at gosmerbio.com in the posters and publications section. On our previously quarterly call, we announced the first patient dose for our Phase II proof-of-concept study of GV001 in chronic rhinocytosis, known as the TITAN study. We plan to enroll approximately 100 patients with chronic rhinocytosis, both with and without nasal polyps, in the TITAN study, which is designed to measure the effect of GV001 on the sinonasal outcome test, or SNOT22 score. After 16 weeks of treatment in patients who are refractory to intranasal steroids. We remain on track to read out top-line data for this proof-of-concept phase 2 study in the second half of 2020. Moving on to our third plan indication for GB001, chronic spontaneous urticaria, or CSU, there is evidence that the TH2 pathway and cell types, such as eosinophils, basophils, and mast cells, are implicated in the pathogenesis of CSU. But the underlying biology does differ from eosinophilic asthma and CRF. To better understand the effect of this difference in biology, combined with our desire to ensure we are targeting the right patient population, we have decided to initiate a smaller translational Phase II trial at CSU in the first half of 2020 prior to initiating a larger study. We also continue to evaluate the potential of GV001 and other allergic and inflammatory diseases such as eosinophilic esophagitis. 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 multiple Phase II top-line readouts in 2020. We'll now move on to GB002, our inhaled PDGF receptor inhibitor for the treatment of pulmonary arterial hypertension, also known as PAH. GP002 has the potential to be the first drug in a new therapeutic class for this destructive and crippling rare disease with high unmet needs and limited classes of approved therapies. GP002 has completed Phase I safety studies in normal healthy volunteers with no serious adverse events observed and has been granted orphan drug designation from the FDA and the EMA for the treatment of PAH. We've commenced an exploratory translational Phase 1b with the goals of assessing the initial safety and tolerability profile of GP02 in pH patients and generating target engagement and biomarker data. While we originally expected to begin patient enrollment in the third quarter of 2019, following the receipt of long-term toxicology data, we amended the trial protocol to include a six-month open-label extension following the original two-week study period. We've been working closely with our Phase 1B study sites and investigators to identify appropriate study participants for our Phase 1B study. We expect to begin enrollment in the fourth quarter of 2019, and we expect an initial readout from the Phase 1B trial in the first half of 2020. As a reminder, this coming Sunday and Monday at the American Heart Association Scientific Sessions in Philadelphia, We are excited to present further GB002 preclinical data and two distinct animal models of PEH. The first presentation demonstrates that inhaled delivery of GB002 is efficacious in preventing pH progression in the RAP monocrytalline anemonectomy model in PEH, and furthermore that GB002 may be disease-modifying through its effect on lung remodeling in this rodent model. The second presentation details the results from GB002 in the SU50416 Hypoxia Rat Model, PAH. In this model, two weeks of treatment with GB002 significantly reduced right ventricular systolic pressure and mean pulmonary arterial pressure. Additionally, decreased plasma levels of NT-proBNP, a biomarker for heart failure, were observed. Review the data presented in these presentations as very promising for the future of the GB00 program in PAH. and if you are our asset, AHA Sessions in Philadelphia, we welcome you to stop by. The abstracts of both presentations are currently on our website and both posters will become available on our website after the presentation. Additionally, based upon consultation with the regulatory authorities and KOLs, we are in the final stages of designing our GB002 Phase 2 study. While the Phase II study may not support registration, we believe that the data generated from this study will be incredibly valuable for future registrational studies by assessing PDR, cardiac function measured by echo, and six-minute walk tests. We plan to initiate the Phase II study in the first half of next year. Next, we will discuss GB004, an oral hip one alpha stabilizer for the treatment of inflammatory bowel disease, including ulcerative colitis, or UC. GP004 is a gut-targeted, cobalt hydroxides inhibitor designed to preferentially stabilize HIF-1-alpha, a transcription factor involved in the body's protective response at low oxygen levels. We were very excited to see that in October it was announced that HIF Biology was subject of the work underlying the 2019 Nobel Prize in Medicine and Physiology. GP004 is currently in a Phase 1b designed to demonstrate proof of mechanism in UC patients. We are enrolling patients with active multi-moderate UC in this four-week study, which is testing one dose of GV004 versus placebo. Patients enrolling in the trial must have active UC as confirmed by MEA4 assessment and evidence of colonic inflammation as confirmed by endoscopy. The primary outcome is safety and tolerability, and we plan to evaluate PKPD and hope to see evidence of target engagement, changes in gene expression, and epithelial barrier restoration. We are also collecting information on clinical effects in the study, including Mayo score, and after the treatment period, patients will undergo either flexible sigmoidoscopy or colonoscopy. We are pleased to say that we are on track to report initial top-line results from the Phase 1b in the first half of 2020. Finally, we will touch on our newest clinical asset, G1275, which is an oral CD11b modulator being developed as an immuno-oncology product candidate. GP1275 is focused on addressing the immunosuppressive myeloid cell populations present within tumor tissues. These tumor types include pancreatic, colorectal, prostate, and other significant tumor indications. And GP1275 has received orphan drug designation from the FDA for the treatment of pancreatic cancer. This morning, we announced that we entered into a clinical trial collaboration and supply agreement with Merck. The study, now known as Keynote A36, is actively enrolling patients with pancreatic, gastric, colorectal, esophageal, and triple negative breast cancer. The baseline portion of the study consists of dose escalation of GP1275 monotherapy, and after clearing several monotherapy dose levels, we will initiate dose escalation combinations with Katrina or chemotherapy. We are very excited to collaborate with Merck, an established leader in cancer immunotherapy, as we work to improve the lives of cancer patients. Our team presented a poster detailing the study design at last week's Society for Immunotherapy and Cancer meeting, which can now also be found on our website. We expect to disclose initial data from the study in the second half of 2020, and we will provide updates as the study progresses. Gossamer Bio retains worldwide rights to GP-1275. With that, I will hand it over to Gossamer Bio's Chief Financial Officer, Bryan Giraudo, for a financial update. Bryan?