GOSS - NASDAQ

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 moderate partly controlled atopic asthma. Findings presented subject that Fractional exhaled Nitric Oxide also known as FeNO could serve as a useful prognostic marker for treatment response to GB001. In addition to elevated eosinophil which is a marker we currently using to involve a LEDA study. In the analysis we saw mark reductions in FeNO levels, as well as greater numeric improvements in lung function and asthma control relative to placebo in patients with high baseline FeNO as compared to patients with low baseline FeNO. We are excited about these results and the potential implications of each development of GB001. We have also started to execute our strategy developed GB001 in other allergic conditions driven by Type 2 cytokine biology where GB001 could potentially be first-in-class. We are excited to inform you that we have begun filling patients and our Phase 2 proof-of-concept study in chronic rhinosinusitis also know as a TITAN study. We expect to dose the first patient in the study later in the second quarter. The TITAN study will enroll patients both with and without nasal polyps both of which represents populations of high unmet need with a significant overwrap of the asthma population in vast effected treatment options for patients feeling to respond to intranasal steroids. We plan to enroll approximately 100 patients with the study which is designed to measure the effect of GB001 on the sinonasal outcome test or SNOT-22 score, after 16 weeks of treatment in patients who are refractory to intranasal steroids. This not playing to endpoint has relevance for both patients with or without nasal polyps we also plan on accepting polyps specific endpoints such as nasal polyps square irrespective of patients with polyps as a key secondary endpoint. We expect this study to be done in 2020. Additionally, we are in track to initiate another Phase 2 proof-of-concept study of GB001 in chronic spontaneous urticarial or CSU later this year. Patients with CSU have poor quality of life and little is available to those who don’t respond to antihistamine with the injectable biologic Xolairas the only approved therapy. We also expect that trial to readout in 2020. We are very excited by the potential for GB001 to be the oral treatment of choice across multiple allergic indication and we look forward to 2020 as the data heavy rich year for the program. Let’s now move on to our second adverse event clinical-stage product candidate GB002, which has inhaled PDGFR Inhibitor, we are developing for the treatment of Pulmonary Arterial Hypertension also known as PAH. PAH is an orphan disease of high unmet medical need. While there are currently three classes of vasodilator therapies available for PAH patients, PAH remains a progressive and often fatal disease. GB002 could potentially be the first drug in the new therapeutic class and we believe it could provide disease modifying effects to patients. GB002 has rationally designed after promising clinical results with PAH Gleevec with a multi kinase inhibitor imatinib, which is currently marketed in oncology indications under the brand name Gleevec. Imatinib demonstrated very promising efficacy in the Phase 3 IMPRES study but was hampered by serious safety concerns and was ultimately not further developed in PAH. GB002 was design to be prudent and selective against those formed in the PDGF receptor which we believe are important drivers of the adherent over growth of the cells binding the pulmonary arteries of PAH patients. GB002 also had activity against other kinase potential for inhibitor PAH such as c-KIT that doesn’t have activity against BCR c-ABL which is a main target of imatinib. To attempt to avoid systemic toxicity seen in the imatinib study, we are developing GB002 as an inhaled therapeutic delivered by simple to use dry powder inhaler. We believe that the inhaler culmination provides to address locally the blood vessels in the lungs where the disease is present and spare the patients a systematic exposure on that toxicity. We have completed dosing with GB002 and Phase 1 safety studies and normal healthy volunteers and with GB002 was well tolerated with no significant adverse events of those disease. We expect to begin site initiation and patient screening for our Phase 1b and PAH patients later in the second quarter. The Phase 1b will be an explorer to our H translational translation of two week study and up to 24 patients followed by open-label extension which we plan to initiate later in the year. We hope to generate interesting target engagement and biomarker measures from this study and we anticipate a read-out in the first half of 2020. Moving right along to our third clinical stage asset, GB004 is an oral HIF-1α Stabilizer for the treatment of Inflammatory Bowel Disease including ulcerative colitis or UC. IBD is a disease we know very well given our teams experience a number of IBD therapeutics including Ozanimod and there is an increasingly crowd of space long-term clinical admissions and mucosal healing list for IBD patients remain low and thus we believe there is still significant unmet need for these patients. The clinicians we spoken to are designing our clinical program have been very excited by GB004 oral valid administration and the novel differentiated mechanism of healthcare we are pursuing. GB004 is a gut-targeted prolyl hydroxylase inhibitor design to preferentially stabilize HIF-1a, a transfusion software involved in the barrier protective response for low oxygen levels. It has been demonstrated that lower than normal oxygen levels are present in the intestinal tissue IBD patients, which contributed to distraction of the mucosal barrier and perpetually inflammatory process. In preclinical IBD model, HIF-1a stabilization is neurogenic dues protective mechanism involve promoting various functions, epithelial reconstitution and reducing inflammation ultimately resulting in healing of mucosal. While we have also change some potentially important immunomodulatory effects of GB004 in preclinical model. GB004 is not a mechanism of action it is unique and that enhances epithelial barrier function and repair rather than active purely immunosuppressive mechanism. As we are running Phase 1 studies in healthy volunteers outside of U.S., we now have an active IND and are very pleased to announce that we have begun cleaning in a Phase 1b trial in patients with active mild to moderate DC. We expect to dose our first patient in the study in the second quarter. We will begin dosing patients for four weeks and potentially increase the length of dosing to eight weeks following the completion of preclinical studies. The study designed to demonstrate activity and UC patient based on targeting engagement, changes in gene expressions and epithelial barrier restoration and potentially UC symptom improvement. We anticipate that this trial will have an initial readout in the first half of 2020. Finally, GB1275 is our oral CD11b modulator for the treatment of cancer. GB1275 is our first immuno-oncology product candidate and we are very excited about the preclinical data it has generated and difficult to treat tumor model. Our strategy in immuno-oncology is a focus on tumor type that have either primary or secondary visits to anti-CD1 in maincheck point therapy. The key factor on both forms of resistant I think in made immune cells such as Myeloid-derived suppressor cells or MDSCs and tumor-associated macrophages, or TAMs recruited by the tumor to suppress the immune response. At pre-clinical studies modulation of CD11b and GB1275 reduce trafficking of those immune cells into tumors and importantly also converted or depolarize them from depressive state to a proven reformatory state. We have recently submitted our IND to the FDA and subject to the FDA review we plan to initiate a Phase 1/2 study in advanced solid tumor indications in the second half of 2019. The Phase 1/2 study will investigate GB1275 and multiple tumor type including pancreatic, gastric, colorectal, esophageal, and triple negative breast. These are all tumor types were immunosuppressive biology and CD11b expression in cells as prevalent. The Phase 1 portion of the study consists of dose escalation of GB1275 monotherapy followed by dose escalation combination with anti-CD1 therapy or chemotherapy. When we reach a recommended Phase 2 dose, we plan to open in the same protocol three Phase 2 expansion cohorts with anti-PD1 therapy or chemotherapy in first line metastatic pancreatic cancer, second line or greater microsatellite stable colorectal cancer, and second line or greater PD 1 positive gastric or gastroesophageal cancer. I am very proud of the work our team has done to add GB1275 to our portfolio of clinical stage product candidate and we look forward to bringing GD1275 into the clinic later this year. It has been a very busy few months and we are proud of the progress we have made in building out a diverse portfolio of assets targeting indications with high unmet needs. Before I turn the call back over to Bryan, I also want to highlight that we will be hosting a fireside chat this afternoon at 4 p.m. Eastern Time at the Bank of America/Merrill Lynch Healthcare Conference. And that event will be webcast live for all those who would like to join. Please see the Investor Page on the Gossamer Bio website for further details. With that, I would now like to turn the call back over to Bryan Giraudo for a financial update. Bryan?

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 time which is greater than what has been a DP study footprint. We have about 18 to 20 minute receptor residence time. Novartis publishes around 12 minutes and we do think that's very important for the mechanism of action here as we inhibit PGD2 to internalization of the DP2 receptor in a very effective manner. And also very importantly, we have - we think later PK characteristics for GB001 and that would be different, and it has to go up to 150 and 450 milligrams to really reach their exposure that they think are clinically efficacious and we are able to achieve that with much lower dosing and we think actually better coverage over a 24 hour period than those dose levels. So there is a potential that we could show really potentially better efficacy in the clinic and in the case that maybe different doesn't meet their marks. So those are very important characteristics for us, for GB001. We will be watching closely to see what the clinical efficacy and safety profile is coming out of the fevipiprant Phase 3 trial. And of course, we are greatly anticipating seeing our interim data in the first half of 2020 followed by the full data readouts later that year. So that's the first question. With that, I am going to move on to the second question and the GB there for the follow up. On the Phase 1 of GB002. Yes that was a very exciting trial for us because we obviously took the inhaled formulation of GB002 into normal healthy volunteer was a single finish dose cohorts and multiple finish dose cohorts. And we are again very pleased with the PK profile that we're seeing coming out of that study and we are seeing absorption rapidly into systemic circulation but with fast clearance. So we have the short a half life. We also do not see dose accumulation upon multiple dosing which is what's important for us to make sure that we were ruling that out. So the profile I really have a increased lung exposure compared to systemic exposure is being confirmed in the clinic and we're looking forward to taking this dose regimen into now PAH patients in the Phase 1b trial to confirm the PK characteristics that we're seeing in the normal healthy volunteers. And again, just to remind you we expect to have several fold higher exposure in the lungs compared to the systemic exposure, which is really the crux of the differentiation that we want to maximize efficacy and minimize systemic toxicity. And the safety and tolerability profile where very robust in that, we do not see any significant adverse events and the inhaled formulation was very well tolerated a normal healthy volunteers so, again very - that's very nice data for us and confirming that the dry powder inhaler and the formulation is being well tolerated. With that I’ll hand over it to Bryan.

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 looking at the reduction of pacification of the sinuses with CT. We're also looking at the quality of life question coming out of this area and really looking at aspects of chronic rhinosinusitis in terms of chronic rhinosinusitis exacerbation, requiring oral steroids or emergency room visits and things of that nature which is similar to how we think about severe exacerbations in asthma. So, again robust study from our perspective and -- that in two different populations and between all the different employees we're going to be looking at, we think we'll get a nice read on whether activity level here and there's a significant amount of PH2 biology that's really driving both of these populations. So we think that that makes sense. Now the second indication of chronic urticaria and just you were asked about the enrollment challenges. With chronic rhinosinusitis, we’re pretty excited we don't know of any really significant competitors out there right now, again especially with the oral. So, we think we can enroll that trial and say in our timeline. So we don't have any significant concerns at that point. And again have begun screening patients here and are very excited to involve patient later in the quarter. So Chronic urticaria again, well validated pathway -- development pathway. We have - they're approved there. Ligelizumab, the next generation anti-IgE antibodies coming forward from Novartis and two large Phase 3 trials and there are other biologic there do some exploratory work within urticarial. And so here we’re looking at the urticaria activity score seven and urticaria control test. And so we have a pretty good idea of what would be a clinically significant or relevant improvement in urticaria's symptoms. And we don't have to do a very large study and sample size actually get a pretty good read on clinical activity and efficacy. And here again while Ligelizumab is going forward in a very large Phase 3 program, we do think there is a lot of excitement around in oral. And so you know, we are excited there is a BTK inhibitor that is being studying urticaria as well. But there's a lot of excitement around the DP2 receptor biology, especially when it comes to the inhibition of basal cell and that cell function which are the key cell types within urticaria. So we're getting very good receptivity from KOLS and investigators in the space and we don't anticipate a significant challenges in recruiting this trial.

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 assess the clinical activity especially, with the high lung exposure we think we'll be achieving in the clinic. So, there's a few. I'll jump to 004 and again here this is some really exciting target engagement data. I'm looking at HIF-1 alpha levels as well as HIF-1 alpha gene expression, a signature that we've been looking at preclinically. And we have seen some nice data on this even looking at the Phase 1, normal healthy volunteers where we get chronic biopsy, we actually saw some target engagement there in that population. And so that's something that we think we'll continue to study and the ulcerative colitis population there, because we're enrolling patients who have active histology and we're looking at a histopathology index, that is up by robots. To see what is the impact on that histology over time, so patients can only get into the study, if they have active pathology on screening. So, that'll be again a nice measure of clinical activity and then because we're doing endoscopy either colonoscopy or flexible sigmoidoscopy, we'll be looking at the mucosa directly and we'll be able to really assess the mail score. With four or eight weeks of treatment that's really the induction timeframe of where we can start seeing some clinical improvement. So a lot of data will be coming out of that Phase 1b trial. So again pretty exciting studies from our perspective and we think we should get some nice data readouts by first half of 2020. And then lastly on business development, we are continuing to do active business development. You are right. We are executing on a number of clinical programs. And so that's really where our focus has been and we are very focused on execution right now, to make sure we meet our milestones and we're generating clinical data, not only on GB001 across the three indications, but really on our pipeline as well as GB1275. And in that we will have data readout that will be meaningful coming out of these programs in that same timeframe as the 001 data readout. So that obviously top of mind. But, we do have a very active business development on effort. We get a lot of inquiries and we see a lot of programs that we're interested in. Where we are guided to right now that we're primarily looking at programs in the late stage research arena and those are programs that will let to our research portfolio and pipeline and we'll be coming into that clinic in that 2021 and 2022 timeframe. So I think that that's really where most of our business development efforts have been, looking at programs that we're excited by about either the target biology that is known to us that we think we could really be differentiated or a novel biology that we think would be truly innovative. So we're hoping to continue to pursue those efforts and announce as we conclude some of those deals.

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.