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spk04: and thank you for standing by. Welcome to the Gossamer Bio Q2 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 keypad. And if you require any further assistance, just press star 0. And I would now like to turn the call over to your first speaker, Brian Jurado, Chief Financial Officer. You may begin your conference.
spk02: Thank you, Operator, and thank you all for joining us this afternoon. I'm joined on today's call by Gossamer Biles Chairman, Co-Founder and Chief Executive Officer, Christine Hadley, Richard Aranda, Gossamer Biles Chief Technical Officer, as well as Laura Carter, Gossamer Biles Chief Scientific Officer. Earlier this afternoon, Gossamer Bio issued a press release announcing its financial results for the second quarter ended June 30, 2021, 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 consensual information that may be accurate for only a limited period of time. Our ability to meet our guidance, especially that related to timely initiation and completion of our clinical studies, in addition to our ability to release results from our clinical trial in a timely manner, may be adversely affected by the ongoing COVID-19 pandemic. Gossamer Bio takes no obligation to revise or update any forward-looking statements or events or circumstances after the date of this conference call. Now I'd like to turn the call over to Padim.
spk09: Thanks, Brian, and good afternoon to everyone who's joining us on today's call. We appreciate you tuning into this earnings and update call to discuss our efforts at Gossamer and the efforts that we've been making to develop new medicines to meet unmet needs across a variety of diseases. I've branded 2021 as a year of execution for Gossamer, and our team has worked tirelessly to set the stage for 2022 to be a transformative year for our portfolio. I'm going to turn the call over to Richard in a minute to give you a more detailed update. But to start, the highlights are that we're on track to have two phase two data readouts for our two lead clinical programs, serolutinib and GB004, in the first half of 2022, of course, subject to further developments in the pandemic. Much of the focus on the call today will be on serolutinib. So I'm going to start with GB004 as I view this as an equally exciting part of Gossamer's portfolio. The SHIFT-UC study of GB004 is enrolling 195 patients with active ulcerative colitis despite treatment with 5-ASA and evaluating the induction of clinical remission at 12 weeks as its primary end point. We believe that GB004 has a potential to disrupt the treatment paradigm in UC and Crohn's disease as an oral, non-immunosuppressive product candidate that's meant to induce mucosal healing in patients with inflammatory bowel disease. We're looking forward to the results of the SHIFT-UC study in 2022. Now, moving on to serolutinib. The TORI study is enrolling 80 patients with pulmonary arterial hypertension and evaluating change in PVR at 24 weeks at its primary endpoint. Serolutinib has the potential to be a disease-modifying treatment for PAA patients for whom the only currently approved treatments are vasodilatory and do not affect the underlying disease pathogenesis. And we're also excited today to give you a glimpse of the open label data generated with serolutinib. As a reminder, serolutinib is an inhaled PDGFR C-kit and CSF1R kinase inhibitor, which is currently enrolling a phase two study in PAH patients. Now the pandemic allowed just two patients to complete the open label extension. So while the data set is limited, these case studies give us greater confidence that we're on track As we look forward to the readout next year from our 80 patient phase two Tory study. Now, without any further ado, I'd like to hand it over to Dr. Richard Aranda, Gossamer Bio's chief medical officer, who will provide this update on the Sarah Lutna program, as well as an update on our other lead clinical program, GB004. Richard?
spk10: Thank you, Fahim. Today, I am very excited to give an update on the serolutinib program, including a look at the safety and tolerability, biomarker, and clinical activity data we obtained in our Phase 1b open-label extension. As you know, last year, we conducted a Phase 1b in WHO Group 1 functional class two through four PAH patients. The placebo-controlled randomized Double-blind two-week treatment period was designed to evaluate the safety and tolerability of inhaled serolutinib, as this was our first experience with serolutinib in patients with PAH. Patients started off at a dose of 45 milligrams BID, and we were dose escalated up to 90 milligrams BID at the investigator's discretion. In addition to safety and tolerability, We also were interested in evaluating the plasma PK and PD profile of serolutinib and the assessment of target engagement. This Phase 1b study included an open-label extension period in which patients could receive serolutinib for up to six months. We enrolled our first subject in the study in the first quarter of 2020. Unfortunately, the first wave of the COVID-19 virus caused site closures and did not allow the initial group of patients on the study to continue onto the open-label extension. As sites began to reopen, we had two patients who enrolled and were able to complete the six-month open-label extension. We were very happy to get some initial experience with serolutib in patients with pH for up to six months, which, to our knowledge, is the first such data for an inhaled kinase inhibitor. I'll share some of that data in a few slides. But first, on the next slide, I want to take you through how we arrived at the 45 milligram and 90 milligram BID doses we tested in the study. Several approaches were used to inform on dose selection, and we have been pleased thus far to see that the PK and target engagement data validate our thinking. To remind you, serolutinib was selected and formulated to be an inhaled therapy for PAH that achieves deposition in the deep lung, resulting in greater lung to plasma exposure, and hence potentially a more favorable safety profile. With this intention, our dose levels were informed by a combination of animal model data, allometric and direct scaling, and PK results from human studies. On the left panel, studies in rats indicate that the lung to plasma exposure ratio is on average 30 times with a half-life that was approximately double in the lung, consistent with serolutinib's intended profile as mentioned previously. In terms of allometric and direct scaling approaches, we used efficacy data from animal models of PAH. In the Sugen hypoxia model, where serolutinib demonstrated an improvement in hemodynamics and an effect on remodeling, a dose level of 12.8 milligrams per kilogram approximates a 90 milligram BID dose in humans. Finally, we utilized the systemic pharmacokinetic data we generated in our human studies from NOMA Healthy Volunteers. Based on the animal model exposure, scaling predictions, and plasma exposures, we wanted to ensure adequate levels of drug would be in the lung over the dosing period. We were pleased to see that both our doses are projected to provide adequate free lung concentrations of serolutinib above both the biochemical and cell-based IC50 values for PDGFR alpha, PDGFR beta, and CKIT, and the cell-based IC50 for CSF1R for a 24-hour period. We will further describe these predictions in the next slide as we discuss are PK and target engagement results from PH patients. One of the key objectives of the Phase 1B study was to ensure that there were no major PK differences in PH patients compared to normal healthy volunteers. Our data indicated that the PK was similar between PH patients and normal healthy volunteers. This panel shows the total drug PK profile of inhaled serolutinib at the two doses of 45 and 90 milligrams. The PK is characterized by a rapid Tmax of five to six minutes with approximately a four-hour half-life in the systemic circulation. Because we believe that efficacy will be driven by free serolutinib concentrations in the lung, the next panel on the right shows the projected free drug concentrations in the lung. This slide also shows the observed plasma concentrations from the pH patients. Both are overlaid starting from the bottom up onto the biochemical IC50s for PDGFR alpha, PDGFR beta, CKIT, and CSF1R. Using the 30 times lung to plasma exposures we observed in our preclinical studies, the concentrations achieved in the lung with the 45 and 90 milligram doses are projected to be adequate to inhibit the targeted kinases. More specifically, as you can see, the orange and green PK curves, again representing the model lung concentrations of the 90 and 45 milligram doses respectively, remain above the biochemical IC50s for both PDGFR receptors and CKIT, over the course of 12 hours and CSF1R partially over that time period. With BID dosing, we expect this would provide adequate target coverage in the lung over 24 hours, which may translate into efficacy and PAH. Of note, the observed rapid clearance of serolutinib in the plasma is just as important as our extended coverage in the lung. We believe this profile is essential to help avoid the tolerability and safety liabilities seen with orally administered kinase inhibitors, such as imatinib in the Phase III and PRESS trial in PAH. One of the key measures of pharmacodynamic effect we employed in our Phase IB study was a flow cytometry-based CSF1R targeted engagement assay in whole blood. This took advantage of the fact that serolutinib targets the CSF1 receptor, and it could be used as a measure of drug effect through inhibiting receptor internalization. As shown in the bar graph on the left, five minutes following inhalation of serolutinib, there is inhibition of CSF1R internalization, which recovers towards baseline at the two-hour time point. We interpret these data as showing First, serolutinib is inhibiting the pathway of one of its targets, which appears to be consistent with the observed plasma PK curves showing initial exposure approaching and then going below the IC50 of CSF1R. And second, it reflects the intended profile of serolutinib. That is, rapid clearance from the systemic circulation, lowering the chances for the occurrence of systemic adverse events. Overall, it's encouraging to us that these PK and PD data support the pharmacologic activity of our dose predictions. Next, we would like to turn to the results from our Phase 1b study in PAH patients. We had eight subjects who completed the two weeks in which serolutinib was generally well-tolerated. The most frequently reported adverse events were mild to moderate cough, associated with inhalation and mild headache. There were no clinically significant change in labs, electrocardiograms, pulmonary function tests, or vital signs. New additions to this slide from versions we have shown in the past are data from the open label extension. As a reminder, given COVID-related site closures during the first wave of the pandemic, we were limited to two patients who enrolled in the fall of 2020 with extended open-label experience. This small N requires caution when interpreting results from the experience, but we found the data encouraging and wanted to share it with all of you. As background, both subjects were classified as functional class 2 and came into the study on three background therapies, including oral prostacyclines. We were reassured to see that serolutinib was tolerated when combined with standard of care therapies in these subjects. No serious adverse events occurred, and no safety concerns were identified during treatment. On the right side of the slide are biomarker and six-minute walk data that were collected over the course of the full six-month experience for these two patients. The graph on the left shows the change in NT-proBNP which is a biomarker of right heart strain and is used in the risk score calculations of pH patients. Decreases in NT-proBNP were observed in both patients. The graph to the right depicts changes in the six-minute walk test, which is a potential registration of clinical endpoint. Both patients increased their six-minute walk distance over the course of the study. As mentioned previously, we want to be careful not to over-interpret data from just two patients. But we are encouraged to see that both patients tolerated 90 milligrams BID of seriflutinib over six months on top of three background therapies and experienced decreases in NT-proBNP and increases in six-minute walk distance, which are two important measures we are tracking in the TORI study. The next slide highlights that we have an e-poster presentation at the upcoming virtual European Respiratory Society meeting of September 5th on further biomarker analysis from the two-week treatment period, including data gathered on gene expression changes and evidence of pathway modulation. I will close the serolunar update with a quick overview of the phase two TORI study design and endpoints. We are enrolling up to 80 subjects randomized one-to-one to serolutinib and placebo. We will be testing the same doses in this trial as those studied in Phase 1B with patients being up-titrated to 90 milligrams twice a day. The primary endpoint of the study is change in pulmonary vascular resistance, or PBR, at week 24. This study is powered for a change in PVR, and we're hoping to see an 18 to 30% placebo-corrected improvement, which would put us in the same ballpark as the imatinib phase 2 and phase 3 trials, in addition to the more recent tatterset phase 2 results. We will also be looking at six-minute walk tests as a key secondary, though the study is not powered to show a significant treatment effect on this endpoint. Just as a reminder, while Imatinib in its Phase II study and the high dose in the Sotatercept Pulsar Phase II study both showed six-minute walk distance improvements of 21 to 22 meters, neither were statistically significant results. So while we're hoping to see a similar improvement, effort-based endpoints with a high degree of variance, like six-minute walk distance, typically require larger studies to reach statistical significance. We will also be looking at changes in biomarkers like NT-ProVMP. Before I turn the call back over to Fahim, I also wanted to give a quick update on the GB004 program, our HIF-1 alpha stabilizer for the treatment of IBD, including ulcerative colitis. Enrollment in the SHIFT-UC study of GB004 is continuing, and we expect to read out top-line results for the primary endpoint of clinical remission at 12 weeks in the first half of 2022, pending developments in the COVID-19 pandemic. After that 12-week period, patients who have not worsened are kept on their assigned therapy for an additional 24 weeks to evaluate maintenance through a total of 36 weeks. And finally, in October, at UEGW, Silvio Danisi, a former president of ECHO, and a preeminent IBD KOL at Humanitas University will present a post hoc analysis of our completed phase 1B study of GB004 in patients with active UC. The analysis focuses on composite endpoints combining clinical, endoscopic, histologic, and molecular readouts. GB004 outperforms placebo across several composite endpoints demonstrating the breadth and depth of improvement some patients experience on the study while being treated with GB004. Use of composite endpoints may decrease placebo response and enhance signal detection. And we are excited to be pushing the field of IBD research forward alongside Dr. Dinesi and our other close advisors. With that, I will turn the call back over to Fahim, but I'm happy to answer any questions on the SARA LUTNIP or the GB-004 programs during the question and answer session.
spk09: Fahim? FAHIM RAHMANI- Thanks, Richard. Before I hand it over to Brian, I just want to address the future of the GB-1275 program. As was stated in our earnings release, Gossamer is in the process of discontinuing clinical activities related to GB1275, which is an oral CD11B modulator for the treatment of solid tumors. And while we've generated some encouraging biomarker data and still believe that addressing immunosuppressive cell types in the tumor microenvironment holds promise for patients, the next step in clinical development would require a sizable Phase II program, which is not an investment Gossamer will make. given our excitement for the Phase II serolutinib and GB004 programs, in addition to the programs in our preclinical pipeline. We want to thank all of the patients, investigators, and caregivers who've contributed to this program. Your efforts are immensely appreciated by the Gossamer team. And with that, I'll hand it over to Gossamer Bio's Chief Financial Officer, Brian Jurado, for a financial update. Brian?
spk02: Thank you, Fahim. We will now review the financial results of the second quarter of 2020. 2021, beginning. We ended the quarter with $405.9 million of cash and cash equivalents. We anticipate our cash and cash equivalents and marketable securities, along with access to our debt facility, will provide us sufficient capital resources to fund operations and capital expenditures into the second half of 2023. Research and development expenses in the second quarter of 2021 were approximately $44.3 million as compared to R&D expenses of $38.7 million in the same period of 2020. G&A expenses were $11.3 million in the second quarter as compared to G&A expenses of $11.7 million in the same period of 2020. Our net loss for the quarter was $59.8 million, equating to $0.80 per share. In the same period, 2020, we reported a net loss of $66.9 million, which equated to $1 a share. With that, I will turn the call back over to Fahim to offer some closing remarks before we open the line for Q&A. Fahim?
spk09: Thanks, Brian. Again, we appreciate everyone listening in today, and we look forward to answering any questions you may have. Operator, please go ahead and open the line for questions.
spk04: Okay, sir, and at this time, if you would like to ask any questions, just press star one on your telephone keypad. To withdraw your question, just press the pound key. We will pause for just a moment to compile the Q&A roster. And your first question will come from the line of Joseph Schwartz. Your line is open.
spk08: Hi, everyone. Thanks very much for the update. I was wondering if you could characterize the current status and maybe pace of enrollment in TORI and SHIFT-UC. I appreciate it's very challenging to project when these extensive undertakings will wrap up beyond your window of first half of 21, but it would be helpful for us to be able to visualize how far you still need to go given the current state of world affairs.
spk09: yeah joe we we have kind of made a point of not commenting on on specific enrollment data and uh you know i think we'll we'll stick to that view but instead continuing to be consistent with our guidance of of when you can expect top line data which again just to reiterate would be first half 2022. so you know that's obviously you know you've got a coveted caveat to that as as most as most companies do, but nonetheless, we feel comfortable and confident in continuing to point to that guidance.
spk08: Okay, great. And then maybe a question on GB004 then. A lot of IBD KOLs we speak with will lament that payers frequently restrict the use of novel agents they'd like to use for earlier stage patients or they'd like earlier stage patients that come to them to have had the opportunity to use. And so disease activity often becomes moderate to severe in a lot of patients that might not otherwise progress to the same extent. So, you know, I'd love to get your thoughts on what will it take for an agent like GB004 to break in where other new agents have had a hard time getting payers to grant broad access? Is it just pivotal data in earlier stage patients, or do you think there'll be some other important things that have to fall into place?
spk09: Yeah, Joe, it's a great question. And I think there's a number of dimensions here on this program. I mean, the profile of the program, I think, lends itself really well to what potentially could be exceptional positioning in the treatment paradigm for IBD patients. And that is that given that it's kind of a non-immunosuppressive approach, we can actually push off and delay the utilization potentially of more immunosuppressive agents and certainly biologics. And I think that in itself has the potential to be a very attractive attribute. There's all kinds of, as we know, knock on potential concerns with agents around safety and the like. So it remains to be seen exactly how payers will treat it. And of course, we'll need to be thinking about a pricing strategy that that fits well with its position in treatment. But both the potential to bring in and introduce a safer agent post-5-ASA failure, pre-biologic, pre-immunosuppressive, I think is pretty attractive. We've had a lot of great feedback from KOLs on this profile. There's definitely a market need, and this is a pretty unique niche. in the context of where this has the opportunity to be slated. And then, of course, the opportunity, assuming that the safety profile continues to play out as we hope it will, the potential for it to be a backbone of therapy to take remission rates to a new level, I think, is a very interesting premise and potential for this agent as well. So, You know, I think long story short, we've got an agent that has the potential to slot into a really important slot, which I believe we'd be able to convince payers of. I think the KOLs already are seeing potential promise for this in context of treatment. And, you know, I think we'll have a lot of wiggle room in the context of how we want to think about our pricing strategies down the road to ensure that there's uptake from a payer perspective.
spk08: Okay, that makes sense. Thanks for taking my questions.
spk04: And your next question will come from Jeff Meacham. Your line is open.
spk01: Hi, guys. This is Olivia Barrera. I'm for Jeff. Thanks for the questions and congrats on the update. I know COVID was obviously a big factor in why it only included two patients. But when we think about the open label portion for the Torrey study, are there any things outside of the pandemic-related issues that you guys saw in the phase one that you can do to help increase the conversion rate just for the phase two, given the importance of that longer-term data, you know, especially from a regulatory perspective? And then I have one follow-up question.
spk09: Richard, you want to take that?
spk10: Yeah. I think that, first of all, that there's a great deal of interest in the tori study by both our sites and thought leaders and by patients obviously uh the tori study is going to be much longer uh than the whole experience that we're going to have with our phase 1b and so you know we've learned a lot during the the pandemic first of all uh we've tried to make our study user friendly if you will while not sacrificing quality so we've embedded all of our learnings into our execution of our TORI study and made sure that patients are aware that if they are having benefit in the short term, and even those that are on placebo, that they should continue in the open label extension.
spk02: Olivia, don't underestimate the challenge of an emerging pandemic and a two-week study to convince people to stay on for six months. It's a very different conversation with patients and caregivers when you're talking about a longer standing line.
spk01: Okay, perfect. Thanks, guys. And then, Fahim, when you think about your pipeline priorities looking to next year, is oncology still a focus in an area that you're willing to invest heavily in? I know you haven't disclosed what preclinical assets you might move forward with yet, but are there some internal opportunities, you know, specifically within oncology that you think would make sense to take forward on your own?
spk09: Yes, yes. We do, in our preclinical pipeline, we do have a number of agents that will be vectored towards indications and oncology, and certainly more to come on that as we progress those programs through our pipeline. But, yeah, oncology continues to be one of the areas of pursuit and interest for Gossamer.
spk01: Okay, great. Thanks, guys.
spk04: And your next question will come from Carter Gould. Your line is open.
spk06: Yeah, this is Justin. I'm with Carter. Thanks for taking the question. Looking more broadly at IBD, sort of the recurrent questions and uncertainty over the JAK class in any way changed how you're thinking about 004? I mean, clearly there's a lot of attractiveness about a non-immunosuppressive profile. But now sort of given the lingering CV issues there, does that just reinforce your previous view or has there been any further evolution on how you think about the hurdle for clinical meaningfulness there?
spk09: Yeah, I think without a doubt, it actually gives us even greater conviction on GB004 because it continues to stress the need for novel approaches, novel agents, and ideally non-immunosuppressive, uh, uh, approaches. So to me, it really, as I was saying earlier, it kind of puts a spotlight on this program, uh, given its potential and promise and, and, and mechanism of action. So, um, yeah, without a doubt, it just continues to increase our, our, our confidence and, and, uh, uh, in pursuit of this program. Richard, do you want anything else?
spk10: No, I think that's right on. And, you know, patients are really looking for something that potentially could be safer than what's out there. And as Fahim mentioned earlier, that could precede the use of biologics.
spk06: Awesome. Thanks so much for the updates.
spk04: And your next question will come from Patrick Cuccio. Your line is open.
spk07: Hi. Good evening. Thanks. Just a follow-up on the serolutinib program and the OLA data. You know, to understanding this is data from just the two patients, regarding the improvements in the NT-PRO-BMP and six-minute walk distance from baseline, I'm wondering if you can frame for us the clinical relevance of those improvements that were seen in the two patients. and how those could, if at all, read through to an endpoint such as PVR change.
spk09: Sure. Richard, you can take that.
spk10: Yeah. So, you know, first of all, I just want to emphasize that we don't want to over-interpret the results from two patients. But having said that, if you look at the directionality in both patients, that you see a reduction in NT-pro-BNP in six-minute walks, we find that encouraging because it's going in the same direction. You know, as we mentioned, you know, the six-minute walk is encumbered by a lot of variability. But I think we're intrigued by the NT-ProBNP data in particular because it's a pretty good reduction. And once again, it's directional for us. But I think if you look at other studies, the NT-proBNP levels tend to be flat or even go up. And the literature, once again, don't want to over-interpret, but the literature is fairly clear that NT-proBNP is associated with parameters such as right atrial pressure, PVR, and hemodynamics. So once again, as we're trying to point out, it's encouraging.
spk07: Yeah, and I'm wondering if the two patients were more severe than those that would typically be enrolled in the Torrey trial, given that they were on the three treatments at baseline, or if instead would they be more representative of, I guess, the typical baseline care patients with those baseline characteristics for those being enrolled in the Torrey trial?
spk10: No, I think they're going to be quite similar to what we would enroll in the Torrey trial. You know, we anticipate to enroll those with at least two or three background medications. We do require a PVR requirement of 400 dynes, but the baseline NT-pro BMP levels are just right on par with what we would expect.
spk07: Got it. That's really helpful. Thank you.
spk04: And our next question will come from Emma Neelan. Your line is open.
spk03: Hi, thank you for taking the question. Just a follow-up on the OLE here, and again, you know, with the caveat that it's only two patients, but curious if there was anything you saw over the longer six-month treatment period in terms of time course of the cough.
spk10: Yeah, the cough was predominantly seen in the double-blind the first two weeks of treatment. It was very mild. as indicated by the patient and the investigator when they reported it. And it didn't occur necessarily with every single inhalation. Patients, once they got used to inhaling the drug, got used to it. And it wasn't a progressive at all. And no patients discontinued or had to reduce their inhalation of drug due to the cough.
spk03: Great. That's helpful. And then maybe just one for Brian. How should we think about the impact on expenses of winding down the 1275 program here?
spk02: Very minimal. It was a very limited study that we did. And really, I think as Fahim said in the beginning, it's really the avoidance of more expensive phase two studies, which is really going to allow us to focus on delivering 002 and 004 in the timeframe we've talked about, and if we are successful to have a robust balance sheet to enable strategic optionality for both those programs.
spk04: Great. Thanks again. And again, if you have any questions, just press star 1 on your telephone keypad. Your next question will come from David Wong. Your line is open.
spk05: Hi, this is Tom for David, and thanks for taking the question. Just to get a sense of which trial will have the top line data first, TAURI or SHIP-DUC in the next year? And do you know if the phase two trial, DO2 or O4, I mean, if both read out in a positive way, do you plan to advance those simultaneously into phase three? Just get a sense of the plan going forward.
spk09: Yeah, at this point, we're not providing that guidance in terms of which program will read out first. We'll, you know, again, I'll just reiterate, we continue to stick with our guidance of both programs to read out first half 2022. We may give a little bit more specificity down the road, but at this point, that's kind of how we'll be describing things. As it relates to the scenario around two positive readouts on the Phase IIs, we will be progressing both of those programs to the next stage of development and really trying not to miss a beat and trying to minimize any time gaps between the top-line readout of the Phase II and an initiation of our registrational studies.
spk05: Okay, got it.
spk04: And that concludes our question and answer session. I would now like to turn the call over to Saheem Hasnain for closing remarks.
spk09: Thank you very much. I appreciate the questions. I appreciate all of you spending time with us today. We are excited about our programs and looking forward to next year's readouts. I would just like to thank the Gossamer team for incredible efforts, continued incredible efforts, working through extraordinary times, extraordinary circumstances through what has been arguably a challenging year for everybody in the context of the pandemic. But this is a company that has an incredibly dedicated group of professionals, and that gets defined every single day as we make our progress on these studies. as we make progress on the enrollment and look forward to making a tremendous difference for patients. So thank you, everybody. Thank you very much for spending time with us today, and thanks for your questions.
spk04: And that concludes our conference call. Thank you for participating.
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