Good morning, and welcome to the Gossamer Bio First Quarter 2019 Earnings Call. Today's call will feature updates from Gossamer Bio management's team followed by a question-and-answer session. I would now turn the call over to Gossamer's Chief Financial Officer, Bryan Giraudo. Bryan?

Thank you, operator and thank you all for joining us this morning. With me on today's call is Gossamer's Co-Founder and Chief Executive Officer, Dr. Sheila Gujrathi. Earlier this morning Gossamer issued a press release announcing its financial results for the first quarter ended March 31, 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’s 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 and the statements contained in Gossamer's news releases, 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 with all of those wonderful remarks, I will turn it over to Sheila. Sheila?

Thank you, Bryan and good morning to everyone joining us on today’s call. The recent months have been an exciting time for Gossamer and we've had especially busy start in 2019. On today's call I am going to walk you through updates and milestones, achieved product soon to be for clinical phase programs, and then I will hand it back over to Bryan to go over our financial results for the quarter. Since our IPO which closed in February, we have rapidly moved towards our goal of becoming a leader in immunology, inflammation, and oncology. We are setting a foundation this year for multiple data readouts expected in 2020. Let me start with our most advanced clinical phase product candidate GB001 and oral DP2 antagonist which is being developed for eosinophilic asthma and other allergic condition including, chronic rhinosinusitis both with and without nasal polyps and chronic spontaneous urticaria. As we have previously announced, our Phase 2b trial in moderate to severe eosinophilic asthma known as a LEDA study is currently enrolling patients and we remain on track to trigger and interim analysis in the first half of 2020. The LEDA study is testing three one single doses of GB001 20, 40 and 60 milligrams against placebo in the 24-week study. All patients will remain on background therapy throughout the study and the primary endpoint is a compositor known as asthma worsening. If the interim analysis of the study in the first half of 2020 is positive, we plan to begin the first of two Phase 3 trials design to support NDA legislation with the FDA. In February at its AAAAI meeting in San Francisco Dr. Hector Ortega who is leading development of GB001 at Gossamer presented results of a post-hoc analysis of GB001 study in patients with mild to…

Thank you, Sheila. I will give a brief summary of our financing activities over the past few months before going over the results for the quarter. As previously announced in February, we closed our initial public offering in which we raised over $291 million in net proceeds. Following the close of our IPO we announced $150 million debt facility lead by MidCap Financial. 30 million of that facility was taken down at the closing of the agreement and a 120 million will be available to Gossamer subject to the achievement of certain clinical development milestones and other customer accreditation. With these two financings Gossamer is in a very strong cash position with our cash runway extending into the second half of 2021. Now on to the financial results for the first quarter. We ended the quarter with $492.5 million of cash and cash equivalents which also included a $11 million interest in securities receivable which we received following the quarter end. This does not reflect the initial proceeds we receive at the signing of the MidCap facility. Research and development expenses were approximately $25 million in the quarter, which reflects a ramp up of expenses for GB001, GB002 and GB004. In process R&D expenses, which consists of costs related to the acquisition and licensing of our product candidates were approximately $1 million in the quarter. G&A expenses were $8 million in the quarter with nearly $2 million of that in stock based compensation. Our net loss for the quarter was $32.6 million equating to $0.90 per share. With that, I'll turn the call back over to Sheila to offer some closing comments before we open up the line for the questions and answers. Sheila?

Thank you, Bryan. At Gossamer Bio, we are thrilled with the momentum we have generated in developing our multiple products candidate that we believe have the potential to significantly better the lives of patients and their families. We're also incredibly proud of our great team who was realizing our vision at Gossamer Bio. Our strong financial position allows us to continue to advance our science for the benefit of patients, caregivers, physicians, employees and shareholders alike. Thank you for taking the time to join us today and for your continued support. With that, I will now turn the call over to the operator to begin the question-and-answer session. Operator?

[Operator Instructions] And our first question comes from Ying Huang with Bank of America/Merrill Lynch. Your line is open

So maybe a two quick ones for Sheila. First one is all the investors been looking forward to the result from Novartis on the first batch of clinical data from Phase 3 trials for slightly different. So can you talk about the read through if it's positive, what is that mean for GB001,which is obvious, I guess, and then which is negative how should we think about ending comparative advantage you will come on GB001 may have against slightly different here. And then secondly, you completed the Phase 1 trial for GB002 in healthy volunteers, can you talk about findings in terms of the PK dose response and PD besides the fact that is no SAE from the trial? And then quickly for Bryan, can you talk about why you took that - I guess financing our capacity from kneecap. Is it because you need additional cash to support ongoing development or not.

Thank you. Great questions. Yes. So let's start with the Novartis studies in batch programs. We are also very much looking forward to their Phase 3 data readout. Just to remind everyone, they have a large Phase 3 program actually consisting of six Phase 3 trials within asthma, four of those Phase 2 trials are reading out later this year. In terms of their recent guidance that is still on track. So we are anticipating they have two exacerbation trials that will be reading out in September and December timeframe and then to SAE one to one function trials reading out in around November. So these are the luster and deal trials that will be leading up. And so if that those trials are positive in the moderate severe asthmatic population, including a subgroup of incentive so high patient with that is very much validation of the mechanism of DP2 antagonism. And so I think that would be positive read through to our program, because of a similar mechanism of action that we are - both the program share. So we are very much looking forward to that and other going into a broad moderate to severe or even adult asthma population, but their primary endpoint is on the subgroup of highly clinical or PH 2 high subgroup. And we do know that they have stated that that is their base case in terms of where they think there will be positive data, which is very consistent with the way we view the biologic relevance and activity both GB002, antagonism and for GB001. Now, we do have some points of differentiation of fevipiprant. We have a very potent collective molecule which is GB001 and that we have high binding infinity to the DP-2 receptor. We also have prolonged reflector resistance…

Yes, taking the amount of the question regards to midcap Jeff. We put that in place purely as a means to ensure that the runway was very, very sufficient well into 2021. As I had said with seven milestones next year, we want to make sure that we could deliver that news and those milestones to our investors and still be able to communicate robustness of the balance sheet, to target the next level of clinical work that would be on the council. So it really a means to ensure long term runway and access to capital.

And our next question comes from Joseph Schwartz with SVB Leerink. Your line is open.

I was wondering if you could talk about the signals that you've been looking for to see if GB001 has activity in some of the newer areas you've outlined going into, such as chronic rhinosinusitis with and without nasal polyps in chronic spontaneous urticaria. It seems like development in some of these spaces has been enough more across pharma too. So as the increased activity may execution of a challenging in any way.

Yes. Thanks, Joe. Well again, we're excited about these additional indications we're going after and it is actually more white space in that, we are the only oral, which really moving forward into the chronic rhinosinusitis, with or without polyps and chronic urticaria disease area. So, I'll start with chronic rhinosinusitis, again with or without polyps and here the study is really designed to involve patients in both populations. Now the primary endpoint is looking at now 22 clinical outcome measure, which is a 22 outcome point questionnaire. And we're going to be busy looking for what we consider clinically meaningful improvement looking at those outcome measures. And that's very relevant for patients either with or without polyps because it really gets that a lot of the nasal symptoms that these patients have including nasal obstruction, congestion, loss of a sense of smell and other symptoms that are very pertinent and really debilitating for these patients. In addition as I mentioned, we will be looking at the nasal polyps score and this is a validated endpoint that actually being brought forward with diplomats in their Phase 3 trials, as diplomat has applied to the FDA as a supplemental DLA that application has been accepted and is under priority review at this time. And so they have looked at the endpoint of nasal obstruction and congestion as well as looking at the reduction nasal polyps for. And so that is something also that we're very keen to understand in the subgroup of patients that have nasal polyps. So, we are looking again for what we consider clinically meaningful improvement or reduction in that nasal polyps score as well. So we have a number of other outcome measures that are exploratory but very exciting. We're looking at CT scan outcomes, so we're…

And if I could ask one on GB001 and Asthma for the interim analysis that I think is guided for the first half of 2020. What data will you evaluate in the interim analysis versus the final analysis and is there any opportunity to adjust course in between the two analysis?

Yes, I think they’re pretty robust data readout. This is a substantially site study. So we’ll have about s320 patients. They'll have a 24 weeks worth of data. And of course, we'll have even more patients that will have additional data of varying duration less than 24 weeks. In the interim analysis it’s really designed to look at efficacy across a number of endpoints. So our primary endpoint is looking at asthma worsening, and so that’s a clinical composite outcome measure, very similar to what we studies in Phase 1, Phase 2 trials and then other clinical trials where you will look at different measures of rescue medication use, of course exacerbations, a worsening of lung function and the like. So we'll look at the totality of the outcome measures of asthma worsening reduction as well as each point, each subcomponent of that composite measure. Then of course we will look at lung function as measured by FEV1 as well as peak flows and then we'll look at a number of other safety tolerability PK exposure. And so I think again we're pretty excited about the robust type of data readout we'll get from that trial. Now the full data readout will be of course on 480 patients with 24 weeks worth of data and this analysis is not really designed to change the design or the conduct of the Phase 2b trial. It's really actually more of an administrative analysis and helps us with Phase 3 planning and the Phase 3 initiation that we may want to pursue if the data is positive that really allows for operational efficiency and allows us to quickly go into Phase 3 program and continue to capitalize on the recruitment and the robust recruitment we're seeing right now in the Phase 2b trail.

And our next question comes from Geoff Meacham with Barclays. Your line is open.

This is Scott on for Jeff. Thanks for taking our question. I'm just wondering as you get closer to commercializing 001 asset in asthma. Have you thought about how you're going to define the moderate persistent market for physicians and integrate yourself before the biologics that are in the severe persisting category and maybe what percentage of the intermediate or moderate patients can you capture before they move directly to that severe persistent category. Thanks.

Thanks, Scott. Really, really great questions. We are spending actually quite a bit of time understanding this aspect of the market vary - in a much more robust manner and including looking at claims, database analysis and really getting that type of insight, as to your point. And we do think this is really where a lot of the market opportunity exists for GB001 in that there is a substantial amount of patients that are considered moderate GINA4 or 5 that is really continuing to have access symptomatology, despite being on inhaled corticosteroids and one other controller medication, that we think is not being addressed by the biologic therapies that are available and approved and on the market today. But we think there are high unmet need. They do not have adequate asthma control and they frankly don't want to go into biologics. They're not very adherent to their ICS, we're looking at even adherence rates of inhaled corticosteroids and it's pretty poor. As you know, there’s actually 50% rate that what we call non-adherence or non-compliance. And understanding who are the physicians who take care of these patients as well and we do see a mix of allergist, pulmonologist and really a subgroup of primary care physicians, who we think could also target with an oral treatment. And so it is around that positioning of our profile where we will have - we think really robust efficacy, similar to biologics, safety and tolerability that will be improved and that oral once a day convenient administration that does not require injectable or infusion and is not administered in the office. And again, it's really greatly anticipated and needed by patients and their prescribing physician. So, we think we have a - we're getting a better idea of how to target that moderate persistent category before the more severe persistent asthma comes on and that's a significant market potential in terms of numbers of patients.

And our next question comes from Josh Schimmer with Evercore. Your line is open.

Thanks for taking the questions. First on 002, if you can elaborate on the specific relevant biomarkers or disease of measures that you're looking for in terms of the magnitude of effects of the signal in the Phase 2 trial for advancing the program. The same question for 004, with the addition of the gene that expression markers. And then third question, how are you thinking about your capacity and optimal timing for additional those efforts considering that over the next year or so you're going to have a number of data points that will really inflect the direction that the company is having. Thanks.

Thanks, Josh. Yes, I'm happy to expand that a little bit further. So for 002, we actually have a number of very interesting biomarkers that we can study in the Phase 1b translational study and where we have also seen good efficacy or activity with imatinib. So, there's actually some precedent there, in terms of characterization of those facts on those markers. So very important marker in this space is what we call the NT-proBNP, a level which is the Brain Natriuretic Peptide, which is a real marker right heart strain in the patient population. And so that's the key biomarker that we're very excited about studying. Again imatinib which show some nice reduction in proBNP levels and preclinically in our own animal models. We've seen a very nice reduction in proBNP and actually greater than what we've seen with imatinib. So that's a key marker for us. In addition, as you probably know in PAH, imaging can be very relevant and very helpful in understanding the efficacy and exceeded a lot of movement to imaging is a non-invasive measure to look at some especially right heart function, strain and muscle mass And so cardiac MRIs and cardiac echocardiograms are important for us. And so, I think we're leaning more towards the MRI field and that is again a more robust outcome measures. But that's another key imaging measure that we're going to be looking at, especially with continued treatment of these patients. And then we'll be looking at PDGF gene expression profiles, we are here looking at some other target engagement assays which get at from the other Kinase. So we may just give us an idea of again target engagement. And so, I think a pretty nice group of biomarker results that we'll be looking at, to see…

And there are no other questions in the queue. I'd like to turn the call back to Sheila for any further remarks.

Well, thank you so much everyone for joining us on today's call. We are very excited that this is Gossamer Bio first earnings call and we look forward to - really getting together with you on a quarterly basis to show you all the profits that we're making and our ability to execute on our clinical programs as we've always said this is what we're trying to build as an innovative research and development engine that can really do a lot but in a very nimble and entrepreneurial way with high quality. And along those lines, I really like to thank the Gossamer Bio team for pulling together, really all this amazing material and continuing to really support our efforts here, as well as the folks on the call. Thanks everyone. Have a great day.

Ladies and gentlemen thank you for participating in today's conference. This concludes today's program you may all disconnect. Everyone have a great day.