Q4 2020 Gossamer Bio Inc Earnings Call

Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Gossamer Bio Q4 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. I would now like to hand the conference over to your speaker today, Bryan Giraudo.

Ladies and gentlemen, thank you for standing by and welcome to the Gossamer Bio Q4 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 one on your telephone I would now and like to hand, the conference over to your Speaker today, Brian Gerardo. Please go ahead Sir.

Bryan Giraudo: Thank you, operator, and thank you all for joining us this morning. I am joined on today's call by Gossamer's co-founder and chairman, Executive Officer Faheem Hasnain, and Gossamer Senior Vice President of Clinical Development Richard Aranda. Earlier this morning, Gossamer Bio issued a press release...

Thank you operator, and thank you all for joining US. This morning, I am joined on today's call by Gossamer and co founder Chairman and Exec.

Executive officer for he and housing.

And Gossamer senior Vice President of clinical development Richard Aranda.

Earlier this morning, Gossamer bio issued a press release announcing its year end 2020 financial results and provide the corporate update please.

Bryan Giraudo: You're at it.

Bryan Giraudo: 2020 financial results and provided a corporate update. Please note that certain information, and all of the 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. However, 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.

Please note that certain information the.

Discussed on the call today is covered off of the safe Harbor provision the IV.

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 the risks and uncertainties associated with the company's business the.

These forward looking statements are qualified by the statements contained and Gossamer news releases and SEC filings, including and the annual report on form 10-K and subsequent filings.

Bryan Giraudo: This conference call also contains time-sensitive information that may be accurate for only a limited period of time. Gossamer Bio takes 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 Faheem. Faheem?

This conference call also contains time sensitive information that may be accurate for only a limited period of time.

Gossamer bio takes no obligation to revise or update any forward looking statements to reflect the events or circumstances. After the date of this conference call.

Now I'd like to turn the call over to the heme.

The aim.

Faheem Hasnain: Thank you, Bryan, and thanks to all of you for joining us on the call this morning. And today, we'll provide you an update on Gossamer's four clinical product candidates, and then Bryan will walk us through the 2020 year-end financial results. We, as a team, have made great progress to date, and we look forward to continuing that progress in 2021.

Thank you, Brian and thanks to all of you for joining us on the call. This morning.

And they will provide you an update on gossamer is for clinical product candidates and then Brian will walk us through the 2020 year and financial results.

And we as the team made great progress to date, and we look forward to continuing that progress in 'twenty and 'twenty, one, which we view as the year of intensely focused execution that will of course, the latest into 'twenty and 'twenty, two where we will share our phase two topline data on our two key parallel proof of <unk>.

Faheem Hasnain: This is a year of intensely focused execution that will, of course, lead us into 2022, where we will share our phase two top line data on our two key parallel proof of concept trials for our co-lead product candidates, Sarah Lutnib, also known as Gb002, for the treatment of PAH, and GB004 for the treatment of inflammatory bowel disease. Now, despite the fact that they're obviously treating different indications, both programs share key characteristics that we find very attractive.

On Sept trials for our co lead product candidates.

Share of Loopnet and also known.

As G B O two.

For the treatment of P. A H and J B O O for for the treatment of inflammatory bowel disease.

And despite the fact that they're obviously treating different indications.

The program share key characteristics that we find very attractive both product candidates are targeting populations of severe unmet need using novel as of yet unapproved mechanisms to address the underlying pathophysiology of disease.

Faheem Hasnain: Both product candidates are targeting populations of severe unmet need using novel, as yet unapproved mechanisms to address the underlying pathophysiology of disease. We believe both assets could be transformative to the current treatment paradigm, as both serolutinib and GV004 have, to date, been generally well tolerated in healthy volunteers and patients, in indications where therapies don't always have clean safety profiles. So let's start with Sarah Lutnit on the treatment of PAA. Seralutinib is an inhaled inhibitor of PDGF, CSF-1R, and C-KIT, and it's currently enrolling patients with PAH in the ongoing Phase II TORI.

We believe both assets could be transformative to the current treatment paradigm.

The share of Loopnet and GB old for half to date, and generally well tolerated and healthy volunteers and patients and indications where therapies don't always have clean safety profile of <unk>.

So let's start with share of Loopnet for the treatment of P. H share of Loopnet is an inhaled inhibitor of PDGF CSF, one of art and C. Kit, it's currently enrolled and ph patients and the ongoing phase two Torrey study.

Faheem Hasnain: As a reminder, we expect to enroll approximately 80 functional class 2 and 3 PAH patients who will remain on background therapy, including triple therapy. The primary end point of the TORI study is change from baseline in PBR at week 24, with a key secondary end point of change from baseline at week 24 being 6 minute walk distance, although the trial is not powered for statistical significance at that 6 minute walk distance.

And as a reminder, we expect to enroll approximately 80 functional class two and three P. A H patients who remain on background therapy, including triple therapy.

The primary endpoint of the toward the study is changed from baseline and P. B R. At week 24.

The key secondary endpoint of change from baseline at week 24, and six minute walk distance. Although the trial is not powered for statistical significance and that in the six minute walk distance.

Faheem Hasnain: Top-line results from the TORI trial are expected in the first half of 2022, subject, of course, to developments in the ongoing COVID-19 pandemic. And I'd like to encourage anyone who missed our KOL-led Sarah Lutnab Investor Day in December to go to the events page on the investors section of our website at gossamerbio.com, where a recording of the event is available.

The topline results from the Tory trial are expected in the first half of 2022 subject of course to development from the ongoing COVID-19 pandemic.

And I'd like to encourage anyone who missed our K O L. Ladd share of Loopnet and Investor Day in December to go to the events page on the investors section of our website at Gossamer bio Dot com, where a recording of the event to the Vale.

Faheem Hasnain: Now our other co-lead product candidate, GB004, is an oral HIF1-alpha stabilizer for the treatment of IBD. GB004 is enrolling in its Phase II trial, which we call the SHIFT-UC study, for the treatment of ulcerative colitis. Now, remember, we expect to enroll approximately 195 patients with mild to moderate UC who will remain on stable background 5-ASA therapy throughout the study. The primary endpoint in the SHIFT-UC study is clinical remission at week 12, with secondary endpoints including clinical response. Histological remission, Endoscopic improvement, and Mucosal Healing.

Now our other co lead product candidate GB Oh, Oh for is an oral <unk> one alpha stabilizer for the treatment of IBD.

G D O O for is enrolling its phase two trial and we called the shift you see study for the treatment of Ulster and ulcerative colitis, and remember we expect to enroll approximately 195 patients with mild to moderate UC, who will remain on stable background five day S. A therapy throughout the.

The study.

The primary endpoint and the shift UC study is clinical remission at week 12, with secondary endpoints, including clinical response hits.

Histological remission.

Endoscopic improvement and you coastal healing.

Faheem Hasnain: The study will also evaluate these endpoints at week 36. Top-line 12-week results from the SHIFT-UC trial are expected in the first half of 2022, again subject to the developments of the ongoing COVID-19 pandemic. And a recording of last week's KOL-led GB004 Investor Day is also available on the Events page of the Investor section of our website at gossamerbio.com. I encourage you also to watch the event recording as well as the Sarah Lutniv event if you haven't already.

The study will also evaluate these endpoints at week 36.

The top line 12 week results from the shift you see trial are expected and the first half of 'twenty and 'twenty two again subject to the developments of the ongoing COVID-19 pandemic.

And our reporting of last week's K O L. Ladd G. B O O for Investor Day is also available on the events page of the investors section of our website at Gossamer bio Dot com and I encourage you also to watch the event recording and as well as the Cera Loopnet the advent and if you haven't already.

Faheem Hasnain: Now, in addition to serolutinib and Gb004, Gossamer is also advancing Gb1275, which is an oral CD11B modulator through a Phase I-II trial for the treatment of advanced hard-to-treat solid tumors. We're currently rolling up to 40 patients in a Phase I expansion cohort, studying the recommended phase 2 dose in patients with gastric or esophageal cancer that We expect to announce further data from this ongoing trial in 2021 once it becomes available.

Now in addition to Sarah Loopnet and GB for Gossamer is also advancing GB 12, 75, which is an oral CD of 11. The modulator two of phase one two trial for the treatment of the advanced hard to treat solid tumors for.

We're currently enrolling up to 40 patients in the phase one expansion cohorts studying the recommended phase two dose in patients with gastric or esophageal cancer that had progressed. After initial response to anti PD, one therapy and in patients with advanced microsatellite stable colorectal cancer.

We expect to announce further data from this ongoing trial and 2021 once it becomes available.

Faheem Hasnain: Now, moving on to our final clinical product candidate, GB001, which is an oral DP2 antagonist for the treatment of asthma. As you may recall, we previously read out top-line results from a Phase 2b LITA study in the fourth quarter of this past year. After discussing those results with both the FDA and the EMA, we do believe that there exists a viable clinical development path for GB001 or our related DP2 antagonist backup molecule for the treatment of asthma.

Now moving onto our final clinical product candidate G. B O of one which is in the oral D. P. Two antagonist for the treatment of asthma. As you May remember, we previously read out topline results from the phase two B Leda study in the fourth quarter of this past year at.

After discussing those results with both of the F D. A and the E. M. E. We do believe that there exists the viable clinical development path for G. B O O one or our related DP two antagonist backup molecule for the treatment of asthma.

Faheem Hasnain: Now, that being said, I want to make it crystal clear that Gossamer will not be advancing a DP-2 antagonist, either GB-001 or its backup, in further clinical trials without a partner. We believe an oral DP-2 antagonist can benefit patients, but we're currently focused on the successful execution of our ongoing phase two trial. With that, I will hand it over to our Chief Financial Officer, Bryan Giraudo, for a financial update.

No.

That being said I want to make it crystal clear the gossamer will not be advancing of D. P. Two antagonist either G. B O O one of.

Or it's back up and further clinical trials without a partner.

We believe and oral <unk> antagonist can benefit patients, but we're currently focused on the successful execution of our ongoing phase two trials.

With that I will hand, it over to our Chief Financial Officer, Brian Gerardo for a financial update Brian.

Bryan Giraudo: Thank you, Faheem. We'll now review the end-of-year financial results for the full year of 2019. We ended the year with $512 million in cash and cash equivalents. We continue to maintain a robust balance sheet, and we anticipate our cash and cash equivalents, plus capital available to us in our debt facility, to provide us sufficient capital resources into the second half of 2023.

Thank you for him well.

I'll now review the.

And of your financial results for the full year of 2020.

We ended the year with $512 million of cash and cash equivalents, we continue to maintain a robust balance sheet and we anticipate our cash and cash equivalents plus capital available to us and our jet facility and provide a sufficient capital resources into the second half of 2023.

Bryan Giraudo: For the quarter ended December 31st, 2020, R&D expenses were $38.9 million, compared to R&D expenses of $42.6 million for the same period in 2009. R&D expenses for the full year 2020 were $160.9 million compared to $143.4 million for the fourth quarter of 2019. 2020 in-process R&D expenses were $5.3 million compared to $1.6 million for the same period of 2020. The full year 2020 expenses were $23.4 million compared to $3.6 million for the full year of 2019.

For the quarter ended December 31, 2020, R&D expenses were $38 9 million compared to R&D expenses of 42 6 million for the same period and 2019 R&D.

R&D expenses for the full year 2020 were $150 9 million compared to $143 four.

And 4 million for 2019.

Fourth quarter two.

2020, and process R&D expenses were $5 3 million compared to 1.65 for the same period of 2000 and full year 'twenty and 'twenty expenses were 23 4 million compared to $3 6 million for the full year of 2019. The increases were primarily attributable to a $15 million payment the air P O and connection with the amendment.

And so the in license agreement of G. Beazer of Israel for what can be accomplished in may of 2020, and the milestone payment of $5 million of connection with the initiation of the phase III clinical trial of several of them in 2020.

G&A expenses and the fourth quarter of 2020 were 50.

Bryan Giraudo: The increases were primarily attributable to a $15 million payment to AirPO in connection with the amendment to the In-License Agreement of GB004, which we accomplished in May of 2020, and a milestone payment of $5 million in connection with the initiation of the Phase II trial of Sarah Hoover in 2000. G&A expenses in the fourth quarter of 2020 were $15.9 million, compared to $11.6 million for the same period of 2019. G&A expenses for the full year of 2020 were $49.7 million, compared to $39.1 million for the full year of 2019.

$8 9 million compared to $11 6 million from the same period in 2019 G&A expenses for the full year 2020 were $49 7 million compared to $39 1 million for the full year 2000 and.

The net loss for the three months ended December 31, 2020 was 66, $64 6 million or approximately 88 cents per share compared to a net loss of 54 points out of the nine or 89 cents per share for the same period of 2019 the.

The net loss for the full year December 31st 2020 was $343 4 million or $3.55 per share compared to a net loss of 100, and a one 3 million or $3.29 per share for the full year ended December 31st 2019.

With that I'll turn the call back over to the Faheem. It's al for some closing comments before we open the line to Q&A theme.

Yeah. Thanks, Brian.

So gossamer.

<unk> 2021.

Focused on programs that we believe will drive value programs.

Bryan Giraudo: The net loss for the three months ended December 31, 2020, was $64.6 million, or approximately $0.88 per share, compared to a net loss of $54.7 million, or $0.89 per share, for the same period in 2009. The net loss for the full year, December 31, 2020, was $243.4 million, or $3.55 cents per share, compared to a net loss of $180.3 million, or $3.29 cents per share, for the full year ended December 31, 2020. With that, I'll turn the call back over to Faheem to offer some closing comments before we open the line to Q&A. Faheem?

Oh, two a share of Loopnet Oh for our <unk>, one alpha stabilizer and G. B 12, 75, the multiple solid tumors, but we also have a robust preclinical pipeline.

That we're very excited about.

But we.

It would be unable to do any of this without the continued incredible efforts of our team.

Our investigators study coordinators and most of all of the patients who enroll in our trials.

So.

To all of you who have been supporting us the the team within gossamer and the team outside of the four walls of Gossamer I'm truly grateful and so with that.

I'll now turn over the call to the operator to begin the question and answer session operator.

And as a reminder to ask the question you will need to press star one on your telephone.

Faheem Hasnain: Yeah, thanks, Bryan. The Gossamer.

But it's for your question press the pound key please stand by while we compile the Q&A roster.

Operator: Enters 2021 focused on programs that we believe will drive value, like OO2, or serolutinib, OO4, our HIF-1 alpha stabilizer, and GB1275 for multiple solid tumors. But we also have a robust preclinical pipeline that we're very excited about. But we would be unable to do any of this without the continued incredible efforts of our team, our investigators, our study coordinators, and most of all, the patients who enroll in our trials. To all of you who have been supporting us, the team within Gossamer and the team outside of the four walls of Gossamer, I am truly grateful. So with that, I'll now turn over the call to the operator to begin the question and answer session. Operator?

Your first question comes from Tyler Van Buren.

Hi team. Good morning, this is Carol for Tyler.

So following the G. These years Euro for event recently, and hoping you could give us some more color on the the disease clearance secondary endpoint for the phase two.

Which is the really interesting and point so how many patients do you expect to see this and and this timeframe and how many do you think you'd need to see to be meaningful and then how do you think regulators will think about the standpoint, maybe as part of the potential pivotal program like is there any precedent for that.

And thanks, I'll turn that question over to Dr. Richard Aranda, He heads up our clinical development team Richard.

Operator: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key.

Yeah. Thank you for him. Thank you for the question.

As you know disease clearance is a relatively new concept.

So it's.

Difficult to sort of put a per.

Operator: Please stand by while we compile the Q&A roster. Your first question comes from Tyler Van Buren. Hi team, good morning. This is Tara on behalf of Tyler.

For amateurs on what we would expect to see.

I think we can probably use.

Some extrapolation on both.

Operator: So following the GB004 event recently, I was hoping you could give us some more color on the disease clearance secondary endpoint for Phase 2, which is a really interesting endpoint. So how many patients do you expect to see this in in this time frame, and how many do you think you'd need to see to be meaningful? Then how do you think regulators will think about this endpoint, maybe as part of a potential pivotal program? Like, is there any precedent for this?

Requiring a histologic remission and mucosal healing and endoscopy and so let's say, that's approximately 20% or so.

And then something north of that probably could be quite meaningful and assuming that there's a difference between placebo and.

In terms of.

As we know you know there's clear guidance on what is required for approval in the disease and so far the guidance has.

Richard Aranda: Thanks. I'll turn that question over to Dr. Richard Aranda, who heads up our clinical development team. Richard?

<unk> commented on in addition to the clinical endpoints more histologic remission endpoints or the value of histology and therefore, the concept of disease clearances has not yet been.

Richard Aranda: Yeah, thank you, Faheem. Thank you for the question.

Richard Aranda: As you know, disease clearance is a relatively new concept, so it's difficult to sort of put parameters on what we would expect to see. I think we can probably use some extrapolation on both requiring a histologic remission and mucosal healing endoscopy. And so, let's say that it's approximately, you know, 20% or so, then something north of that probably could be quite meaningful, assuming that there's a difference between placebo. So, in terms of, as we know, you know, there's clear guidance on what is required for approval in the disease, and so far, the guidance has commented on, in addition to the clinical endpoints, more histologic remission endpoints or the value of histology, and therefore, the concept of disease clearance has not yet been placed within that context by the regulators.

Waste within that context by the regulators so it's difficult on wet.

They would think about it although obviously, if we do see and effect on that particular parameter.

It will be considered within the totality of all of our data, including clinical and histology and that being the most the highest bar and we would have discussions.

The the value of it.

Yeah.

Great. Thanks.

Your next question comes from the line of Carter Gould.

Great. Good morning, guys. So just I guess two for two from me I guess just first on the.

And if you think about executing and shift you see clearly the non immune suppressor and components should be helpful. With the recruitment, but I guess just want to understand if there are other things you're doing to help ensure you you hit these timelines in terms of either reducing the number of clinical visits and such just.

And I think because of a compelling case to make around it.

And you know hitting these timelines, but just.

Richard Aranda: So it's difficult to say what they would think about it, although obviously, if we do see an effect on that particular parameter, it will be considered within the totality of all of our data, including clinical histology, and that being the highest bar, we would have discussions to see the value of it.

With the Covid going on still and the background and maybe some reluctance to visit the clinics of anything youre doing on that front.

And then just also any efforts to.

Potentially do something exploratory and crohn's either in parallel with the ongoing of UC study. Thank you.

Yeah.

The the I'll take the last question first and then I'll turn the first question over to Richard.

Operator: Great, thanks. Your next question comes from the line of Carter Gould.

Certainly crohn's will will be of interest but.

Operator: Great. Good morning, guys. Just, I guess, two for me.

Our view will be too.

Wait until after we've got the phase III results and you see before we would contemplate initiating of crowns Crown study Richard do you want to handle the first question.

Operator: I guess just first on the, as we think about executing on SHIFT, you see clearly that the non-immune suppressant component should be helpful with recruitment, but I guess just I want to understand if there are other things you're doing to help ensure you hit these timelines in terms of either reducing the number of clinical visits and such. Just, you know, I think you guys are a compelling case to make around, you know, hitting these timelines, but, you know, just with COVID going on still in the background and maybe some reluctance to visit the clinics, anything you're doing on that front. And then, also, any efforts to potentially do something exploratory in Crohn's, either in parallel with the ongoing UC study. Thank you.

Sure.

When we.

The design the phase two of shift you see steady.

And consider.

All of the pandemic and the potential of vacations. So we get several things first of all we made sure that we had the right geographic distribution of sites.

For you.

Given sort of the the differences and a pandemic and countries and and things like that second we've made our protocol.

And the user friendly so to speak for the site and for the patients are.

Trying to have tele visits.

Shifting of drug.

And see their home as appropriate.

And et cetera, and.

And third.

We have a great operations and great medical team that is spearheading.

The program, we have great relationships with a number of the investigators globally and.

Faheem Hasnain: Yeah, I'll take the last question first, and then I'll turn the first question over to Richard. Certainly, Crohn's will be of interest, but our view would be to... Wait until after we've got the Phase II results in UC before we would contemplate initiating a Crohn's study. Richard, do you want to handle the first question?

And in conjunction with partnership with the with the C. R O a.

All of these.

Are being executed upon so that we can progress of the program accordingly.

Thank you, yes, and I'll add in all of that and just one other comment and it really expands on Richards last point is that apart from the pandemic, which of course is new to all of US IBD is is something that this team has tremendous depth and experience and Richard and two other gastroenterologists and staff and our clinical operations team.

Richard Aranda: Sure. When we designed the Phase 2 SHIFT-UC study, we considered the pandemic and its potential implications. So we did several things. First of all, we made sure that we had the right geographic distribution of sites, you know, given the differences in the pandemic and countries and things like that.

The core of of the.

Of the team.

And also the team that executed on the Rosanna Mod IBD program, so extremely familiar with the landscape as Richard said and extremely familiar with the sites and the investigators and that really helps significantly for this program.

Richard Aranda: Second, we've made our protocol user-friendly, so to speak, for the site and for the patients, trying to have tele-visits, shipping of the drug to their home as appropriate, et cetera. And third, we have a great operations and a great medical team that is spearheading the program. We have great relationships with a number of investigators globally and, in conjunction with its partnership with the CRO. So all of these are being executed upon so that we can progress the program accordingly.

Operator next question.

Your next question comes from the line of Emma near line.

Hi, Thank you for taking the question I guess, how do you think about what you want and pipeline looks like maybe 12 to 18 months from now and Charlotte and and.

Oh for a potential and it into later stage studies and I guess curious how you think about your excitement for the current preclinical pipeline bursting.

Faheem Hasnain: Yeah, and I'll add in just one other comment, and it really expands on Richard's last point, is that, you know, apart from the pandemic, which, of course, is new to all of us, IBD is something that this team has tremendous depth and experience, and Richard, and two other gastroenterologists on staff, and our clinical operations team, the core of the team was also the team that executed on the Ozanamod I So, extremely familiar with the landscape, as Richard said, and extremely familiar with the sites and the investigators, and that really helped significantly with this program.

The external in terms of and growing our pipeline.

Yeah. Thanks for that question.

The 12 day, if I kind of progressed 12 to 18 months from now obviously, we'll be looking forward as we mentioned to just seeing the topline data and are our two parallel proof of concept programs Oh two.

And now for <unk>.

Beyond that we.

We're certainly expecting to progressing our preclinical pipeline.

We have.

Pretty robust preclinical pipeline, we're hoping we will be actually outlining our first next clinical program will be doing that and later on in the spring.

Operator: Operator, next question.

Operator: Your next question comes from Emma Nealon. Hi, thank you for taking the question. I guess, how do you think about what the pipeline to look like maybe 12 to 18 months from now as serolutinib and O4 potentially move into later stage studies? And I'm curious how you think about your excitement for the current preclinical pipeline versus potentially looking externally in terms of growing that pipeline.

So more to come on and on on the target and our plans for that program and so.

So 12 to 18 months from now I think it's fair to say that we would hope to see.

What will essentially be our fifth program into the clinic. If I. If I include the D. P. T program that <unk> that we talked about earlier, the 12 75 O to O for and then and yet undisclosed program entering into the clinic at that point.

Faheem Hasnain: Yeah, thanks for that question. If I can progress 12 to 18 months from now, obviously, we'll be looking forward, as we mentioned, to seeing the top-line data on our two parallel proof-of-concept programs, O2 and O4. Beyond that, we're certainly expecting to progress our preclinical pipeline. We have a pretty robust preclinical pipeline. We're hoping we will be actually outlining our first next clinical program. We'll be doing that later on in the spring.

And with the with the number of programs continuing to advance and the preclinical pipeline.

And as it relates to.

I think your question and speaking about business development.

Got to a pretty significant.

Faheem Hasnain: So more to come on the target and our plans for that program. And so 12 to 18 months from now, I think it's fair to say that we would hope to see what will essentially be our fifth program into the clinic if I include the DPT program that we talked about earlier, 1275, 02, 04, and then an undisclosed program entering the clinic at that point, with a number of programs continuing to advance in the preclinical pipeline. As it relates to, I think, your question about business development, we've got a pretty significant, entire organization focused on the execution of the pipeline that we've got in place now.

Pipeline as we sit now of the team has done an incredible job of sourcing really great opportunities for gossamer.

Since the inception of the founding the company and in 2018 and so.

Our perspective is that we've got a pipeline of of exciting opportunities.

And so that really suggests that for the time being we'll be we'll be standing down on business development as we really focus the entire organization on execution of the pipeline that we've got in place now.

Faheem Hasnain: Great, that's helpful. Thank you. Your next question comes from Jeff Meacham.

Great. That's helpful. Thank you.

Your next question comes from Geoff Meacham.

Operator: Hey guys, this is Olivia Brayard. Thanks for the questions. Two for me. First, can you just give us some more color, you know, around the interactions with regulators and how that's been going for GBO1 at this point? Is there a phase three development plan in place, or is that something that you know you're really waiting to finalize until there's a potential partner in play? And then, second, on GB1275: what's the longer-term strategy?

Hey, guys just sounds like the Embraer and thanks for the question.

And two for me first can you just give us some more color.

Around the interactions with regulators and and how that how that's been going for GB and one at this point.

Is there a phase III development plan in place or is that something like you know, you're really waiting to finalize and until theres, a potential partner and play and and.

And second just quickly on GB 12, 75, whats the longer term strategy with that asset assuming we see some more positive phase one data later this year are there some opportunities to expand the development there and each.

Operator: Assuming we see some more, you know, positive phase one data later this year, are there some opportunities to expand the development there into other indications going forward? Thanks very much.

Other indications going forward, thanks very much.

Yeah as it relates to.

The interactions with with the regulators and it's been very good extremely constructive.

And and and very helpful.

Faheem Hasnain: Yeah, as it relates to the interactions with the regulators, it's been very good, extremely constructive, and very helpful. So, as I mentioned, we believe that there is a clinical path, a phase three path forward for the program, and a reasonable amount of concurrency between both the FDA and the EMA. That being said, we would not be moving forward with phase three plans in the absence of not having a partner. The program would require a pretty substantial effort, and our view is that we've got a lot of optimism and excitement and potential in the rest of the pipeline. And so we made a clear decision that our view is that we would not progress this into phase three without having a substantive partnership by our side. Richard, do you want to handle the 1275 question?

As I mentioned.

We believe that there is a clinical path phase III path forward for the program and a reasonable amount of concurrence between both the FDA and the EMA.

That being said we.

We would not be moving forward with.

And with Phase III plans.

And the absence of of of not having a partner.

The program would require a pretty substantial effort and our view is that we've got a lot of optimism and excitement and potential and the rest of the pipeline and so we made a clear decision net debt. Our view was that we would not.

This in phase III without having a substantive partnership buyer side.

Richard do you want to handle the 12 75 question.

Richard Aranda: Sure, I think that if we do have a positive signal, obviously, there's always the possibility to explore other tumor types beyond the expansion tumor types that we are currently studying. Right now, the focus is obviously on immuno-oncology for that asset. As you may know, the literature indicates that perhaps the molecule is applicable to some other therapeutic areas, but at this time, we're focusing on our immuno-oncology efforts.

Sure.

Yeah, I think that if we do have a positive signal obviously, there's always a possibility to explore.

Explore other tumor types beyond the the expansion.

Tumor types that we are we are currently studying.

All right.

Right now the focus is obviously and immuno.

Immuno oncology for that asset.

As you May know the the literature.

And <unk>.

Indicates that perhaps the the molecule is.

Applicable to some other therapeutic areas, but at this time, we're focusing on our immuno oncology efforts.

Operator: Okay, great.

Okay, great. Thanks, guys.

Operator: Thanks, guys.

Operator: Your next question comes from Patrick Trucchio.

Your next question comes from Patrick Tokyo.

Operator: Thanks. Good morning. Just one follow-up on the COVID-19 pandemic. So, I'm wondering if you can discuss what impact, if any, at this stage, the pandemic is having on data collection and data integrity and what assumptions around the pandemic or post-pandemic environment are included in the guidance for the expectations for top-line data and the lead programs in the first half of 2022, particularly PAH, which had at least initially been impacted by COVID? Yeah,

Thanks. Good morning, just one follow up on the COVID-19 pandemic. So I'm wondering if you can discuss what impact if any at this stage. The pandemic is having on data collection and data integrity and.

And what assumptions around the pandemic or a post pandemic environment are included in the guidance for the the expectations for top line data and the lead programs and the first half of 2022 particular T and nature of China at least initially been impacted by Covid.

Yeah Richard.

Richard Aranda: Richard?

Yes.

Richard Aranda: Sure, I can address the first question. First of all, there's no impact on data accumulation or data quality. If you recall, 001 was completed during sort of the height of the pandemic, and we had no issues with that program. We took learnings from that program and implemented them in our 002 and 004 programs. So we don't anticipate and we don't expect any issues with data collection and quality because we have measures in place.

Sure.

I can address the first question.

First of all of that Theres no impact on <unk>.

Data accumulation of all of our data quality.

The.

If you recall or one was completed during the during sort of at the height of the pandemic and we have.

No issues with that program, we took learnings from that program and implemented them and our O two and one for programs. So we don't anticipate and we don't expect.

Any issues with data collection and quality, because we have provisions in place.

Faheem Hasnain: And both of our, both of the programs as it relates to kind of pandemic planning and timelines that, you know, to the best of our ability, we've been including our assumptions around, around COVID impact, and beyond just kind of including room in the context of the timeline, really trying to be as innovative as we can in terms of site selection, regional, regional involvement, and looking at ensuring that we are, you know, as we think about So, I can tell you this has been a tremendous focus, not only of ours; I know the entire industry is, kind of, looking at this.

And both of our both of the programs as it relates to the kind of pandemic planning and timelines and that.

To the best of our ability, we've been we've been including our assumptions around.

Around COVID-19 impact and beyond just kind of including room.

Room in the context of the timeline and really trying to be as innovative as we can in terms of site selection regional regional involvement and and looking at.

Ensuring that we are you know as we think about these as global trials in locations, where we've got a better chance of enrollment and better access to patients.

Depending on kind of local circumstances. So I can tell you. This has been a tremendous focus not only of ours kind of the entire industry has and is kind of is looking at this but from our perspective, where we're moving along as we had predicted and we continue to hold to the guidance.

Faheem Hasnain: But from our perspective, we're moving along as we had predicted, and we continue to hold to the guidance that we had laid out earlier. Of course, it's hard to see exactly how this will play out, but hopefully, what we will see in the next 6 to 12 months is, is, kind of a lessening of the COVID effect, but none of us have crystal balls, so we'll have to see.

And that we laid out earlier of course.

Hard to see exactly how this will play out, but hopefully what we will see and the next six to 12 months is a is is kind of a lessening of the of the COVID-19 effect, but none of us have a crystal ball. So we'll have to see.

Operator: Right. Got it.

Alright got it and then just a few follow ups on GBS the earlier for so the UCP.

Operator: And then just a few follow-ups on GB004. So, you know, UC patients who are naive to biologics and JAK inhibitors tend to have improved responses to novel treatments compared to those who have lost response. So, with GB004 positioning being with five ASA failures, though prior to biologics, I'm wondering if you could discuss the baseline characteristics expected in the SHIFT-UC trial and what regulatory expectations are related to these characteristics and endpoints in the earlier disease patient population.

And you see patients naive to biologics and JAK inhibitors kind of have improved responses to the novel treatments compared to the sort of loss of response, so of GBS yours or for positioning and being with father's day failures. The prior to biologics I'm wondering if you could just.

The baseline characteristics of expected and ship you see trial and what regulatory expectations are related to the use characteristics and endpoints and the earlier disease patient population and then secondly, just related to the positioning of GBS or zero for I'm wondering how it can be impacted if at all by some of these competing efforts, including our gut selective JAK.

Operator: And then secondly, just related to the positioning of GB004, I'm wondering how it could be impacted, if at all, by some of these competing efforts, including a gut-selective JAK inhibitor and an S1P modulator that's also moving forward in earlier stages in the more moderate UC patient population.

<unk> inhibitor and and Thats one of <unk> modulators, and that's also moving forward and earlier stage of Nissan and the.

And moderate UC patient population.

Yeah.

Richard I'll take the second question do you want to grab the first.

Sure.

Yes.

The shift you see trial is.

It is enrolling of post five day of say inadequate response population, our inclusion criteria really is including a moderate.

Operator: Richard

Richard Aranda: Richard, I'll take the second question. Would you like to grab the first?

Population more so than mild.

We require endoscopic disease activity, that's consistent with more moderate disease, although they may have.

Richard Aranda: Sure. Yeah, you know, the SHIFT-UC trial is enrolling a post-5-ASA inadequate response population. Our inclusion criteria really are including a moderate population, more so than mild. We require endoscopic disease activity that's consistent with more moderate disease, although they may have milder symptoms. So the net of that is we anticipate enrolling more of a moderate post 5 ASA prebiologic failure population. Having said that, the same regulatory guidelines apply to that population for moderate to severe, which is the classic population that most other therapies have studied. So we don't anticipate any major differences in terms of expectations from the regulators on the type of responses or endpoints that are required.

A more milder symptoms. So net of that is we anticipate enrolling more of a moderate post five bay of say pre biologic failure.

Population.

Having said that the same.

Regulatory guidelines of apply to that population.

For moderate to severe which is the classic population that most other therapies have studied so we don't anticipate.

Any major.

Differences and.

In terms of expectations from the regulators on the type of responses of endpoints that are required.

And as it relates to your question about positioning Patrick.

Faheem Hasnain: And as it relates to your question about positioning, Patrick, I mean, our view is that First off, I think we all agree that mucosal healing rates are still incredibly low, despite available therapies, and that patients, and we've seen this play out in multiple therapeutic areas, that when offered an opportunity to be able to go on an oral therapy and push back the need for a biologic and, in this case, reduce, hopefully, the reliance on steroids.

Our view is that.

The first off I mean, I think we.

All agree that the mucosal healing rates are still incredibly low despite available therapies.

And the patients and we've seen this play out in multiple therapeutic areas that.

When offered an opportunity to be able to go on and oral therapy and push back the need for biologics.

And in this case reduce hopefully the reliance on on steroids.

Faheem Hasnain: I mean, there's pretty incredible need, in the context of other orals coming in. I think there'll be a couple interesting dynamics. One is that, you know, the remission rates are still not where they need to be, and that would suggest that, unfortunately for these patients, they're going to see almost all of the available therapies over their lifetime. And, you know, we see that in other indications like MS, where we see patients cycling through kind of oral to oral to oral, kind of trying to kind of get the disease in check.

I mean, there's pretty incredible need and the context of other oral is coming in.

I think there'll be a couple of interesting dynamics one is that.

You know the remission rates are still not where they need to be and that would suggest that probably unfortunately for these patients they're going to see almost all of the available therapies over the lifetime and we see that and other indications like MFS, where we see patients cycling through kind of oral tow URL to the world kind of trying to.

And to kind of get a.

Disease and in check so.

Faheem Hasnain: So, there's that dynamic, but there's also a safety, an important safety dynamic here. And, you know, if the profile of 004 continues to play out as we hope, we think we would have an agent that not only could have an effect on mucosal healing and endothelial barrier integrity but also with a safety profile that will allow for monotherapy but potentially combination therapy to try to get us to the next level of Disease Management that we would hope to be able to attain.

And there has that dynamic, but theres also of safety and important safety dynamic here and.

And.

If the profile of of Oh for <unk>.

<unk> continues to play out as we hoped we think we would have an agent that not only could have an effect on mucosal healing and and endothelial barrier integrity, but also with where the safety profile of that.

We will not only allow for for monotherapy, but potentially combination therapy to try to get us to the next level.

Of the of disease management that we would that we would hope to be able to attain.

Faheem Hasnain: So, we think the unmet need is large enough, the market size is certainly significant, and the need for a safer profile is pretty clear. So, from our perspective, I think we have a pretty significant opportunity in front of us with this program.

So we think the the unmet need is large enough the market size is certainly significant.

And and the need for a safer profile is pretty pretty clear so from my perspective, and I think.

We have a pretty significant opportunity in front of us for this with this program.

Operator: Great, thank you very much.

Great. Thank you very much.

Operator: Your next question comes from the line of Tong Lu.

Your next question comes from the line of tongue.

Operator: Hi, thanks for taking the question. It's Tom for David from SMBC.

Oh, hi, thanks for taking the question.

It's Tom for David and Tom.

The.

Operator: We have two questions, one for OL2 and the other for 1275. For OL2, can you give any comment on how you see the correlation would be between the polymer vascular resistance and the six-minute work test results? And is there any kind of target range you have in mind for PVR to be competitive?

We have two questions one for one two and the other for top 75 for all of two can.

Can you give any common and how do you see the correlation would be between the.

Pulmonary vascular resistance and the six minute walk test results and there and any kind of target range you have in mind for.

PV or ought to.

The competitive income for our result or in the Pea.

Faheem Hasnain: Form a decision to advance it further into the Phase III trial. For GB1275—a similar question—what are the expectations you would have around the response that you would see in the next readout in order to continue the development?

<unk> space and what is the minimum you see to inform the decision to advance and further into the phase III trial.

And for G. B 12 75.

A similar question what are the expectations I won't you have around the the response that you would see in the next one readout.

For the two to continue the development.

Faheem Hasnain: Yeah, in the context of 002, serolutinib, and kind of their expectations for results, um, in order for us to be comfortable moving to Phase 3, we would hope to see the imatinib-like results that they were able to see in their MPRESS study. So, I think we're hoping that that will be the profile that would play out both on 6-minute walks and PBR. Richard?

Yes.

Yeah, and the context of Oh, two set of Loopnet and kind of the expectation of the results.

In order for us to be.

Comfortable moving to phase III, I mean, we would hope to see the imatinib.

And that and it like results that and.

And that they were able to see in their impress study. So I think where we're hoping that that will be the profile of that would play out both on six minute walk and P. D R. Richard.

Richard Aranda: Yeah, that's...correct Faheem, and just what I wanted to add is that there's I think your question was also around what kind of relationship we would expect, and I think that there's generally considered a reasonable relationship between if you have an effect on a hemodynamic parameter, you should see some benefit on six minute walks, as well.

Yeah that's.

Correct for him and.

Just wanted to add is that there is I think your question was around.

Also around the.

What kind of relationship.

We would expect and I think that there is generally considered.

A reasonable relationship between if you have an effect on the hemodynamic parameters you should see.

Some benefit on six minute walk.

As well.

Operator: And how about the 1275, any color on the expectation of the readout to inform the next steps?

Gotcha.

And how about the 12 75.

And in car on the expectation of.

And read out between for the next steps.

Richard Aranda: Yeah, I think we're in the expansion phase, looking at two particular, actually three tumor types, and the expectation is that we would have a robust result, such as a PR, in the number of patients. And obviously, then we will look at the totality of the data to make a decision on next steps.

Yes, I think there.

We're in the expansion phase.

Looking at the two particular ups and three tumor types and.

And the expectation is that we would have a robust results such as the PR and and the.

And the number of patients.

And obviously then we would look at the totality of the data.

And to make the decision on those thoughts.

Faheem Hasnain: And Tong, we've communicated that we hope to have an update at ASCO and a further update at

Yes.

And Tom we've communicated we hope to have and updated <unk> and a further update at that since he is a trough of vessels.

Faheem Hasnain: Yeah.

Operator: There are no questions at this time. Thank you.

Yes.

Gotcha.

Operator: There are no questions.

Thanks, a lot.

Operating our questions.

Operator: Thank you.

Thank you.

Faheem Hasnain: There are no questions at this time. Do you have any closing remarks?

There are no questions at this time do you have any closing remarks.

Operator: Other than just to thank everybody on the phone, thank you for your thoughtful questions. We look forward to continuing our dialogue, and, as I mentioned to you, we're very excited about other programs that we're working on, and most importantly, we're hoping to make a significant difference for patients. So, thank you all, and I hope you all have a great day.

Uh huh.

Other than just the thank everybody on the phone. Thank you for your thoughtful questions.

Look forward to continuing our dialogue and as I mentioned to you we're very excited about.

Of the programs that we're working on and most importantly, we're hoping to make a significant difference for for patients. So thank you all and I Hope you all have a great day.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

Operator: ??