Q3 2021 Gossamer Bio Inc Earnings Call

November 8, 2021

[music].

Operator: Good day, and thank you for standing by. Welcome to the Gossamer Bio Q3 earnings call.

J T and thank you for standing by and welcome to the Gossamer Bio Q3 earnings call.

Operator: 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. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Mr. Bryan Giraudo, Financial and Chief Operating Officer. Thank you. Please.

At this time all participants are in a listen only mode.

After the speaker's presentation, there will be a question and answer session.

Ask you questions your user during the session you will meet your press star one on your telephone if you require any further assistance. Please press star zero.

I would now like to turn the conference over to your Speaker today, Mr. Brian Toronto Financial and Chief Operating Officer. Thank you. Please go ahead.

Bryan Giraudo: Thank you, Operator, and thank you all for joining us this afternoon. I am joined on today's call by Gossamer Bio's Chairman, Co-Founder, and Chief Executive Officer Faheem Hasnain, Laura Carter, Gossamer Bio's Chief Scientific Officer, and Richard Aranda, Gossamer Bio's Chief Medical Officer. Earlier this afternoon, Gossamer Bio issued a press release announcing its financial results for the third quarter ended September 3, 2021, in addition to providing a corporate update.

Thank you operator, and thank you all for joining US. This afternoon I am joined on today's call by Gossamer Bio's, Chairman co founder and Chief Executive Officer became happening lower Carter, Gossamer Bio's, Chief Scientific Officer, and Richard Aranda, Gossamer Bio's, Chief Medical Officer earlier. This afternoon, Gossamer bio issued a <unk>.

Press release announcing its financial results for the third quarter ended September 32021. In addition to providing a corporate update.

Speaker: Please note that certain information discussed on this call today is covered under the Safe Harbor Provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, Goss...

Please note that certain information discussed on this call today is covered under the safe Harbor provision of the private Securities Litigation Reform Act, we caution listeners that during this call Gossamer management will be making forward looking statements actual results may differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with the company.

Speaker: 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 cautionary statements contained in Gossamer's

These business.

These forward looking statements are qualified by the statements contained in <unk> news releases and SEC filings, including in the annual report on Form 10-K, and subsequent filings. This conference call. Also contains time sensitive information that maybe accurate only for a limited period of time our.

Speaker: All statements contained in Gossamer's news releases and SEC filings, including in the annual report on Form 10-K and subsequent filings. This conference call also contains time-sensitive information that may be accurate only for a limited period of time. Our ability to meet our guidance, especially that related to the timely initiation and completion of clinical studies, in addition to our ability to release results from our clinical trials in a timely manner, may be adversely affected by the ongoing COVID-19 pandemic. Gossamer Bio undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. Now, I'd like to turn the call over to Faheem. Thanks, Bryan.

Our ability to meet our guidance, especially that related to timely initiation and completion of clinical studies. In addition to our ability to release results from our clinical trials in a timely manner may be adversely affected by the ongoing COVID-19 pandemic.

Gossamer bio takes undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call now I'd like to turn the call over to Faheem.

Thanks, Brian.

Faheem Hasnain: And thank you all for joining us today on Gossamer Bio's third quarter earnings and update call. At the end of today's call, we'll conduct a question and answer session. But first, we will discuss our inhaled kinase inhibitor for the treatment of pulmonary arterial hypertension, serolute 1. In the press release we issued earlier today, we shifted our guidance for the top-line data readout for the TORI Phase 2 study of serolutinib to the second half of 2022.

Thank you all for joining us today, and Gossamer Bio's third quarter earnings and update call at the end of today's call, we'll conduct a question and answer session.

But first we will discuss our inhaled kinase inhibitor for the treatment of pulmonary arterial hypertension sterile isn't it.

In the press release, we issued earlier today, we shifted our guidance for the top line data readout inventory phase II study.

The second half of 2022.

And as I'm sure. All of you are aware the COVID-19 pandemic has created unprecedented challenges in conducting clinical trials, including the shortage of medical professional and we believe that these challenged given the nature of Covid were more impactful for our clinical trials and he oriented pulmonary and critical care.

Faheem Hasnain: And, as I'm sure all of you are aware, the COVID-19 pandemic has created unprecedented challenges in conducting clinical trials, including a shortage of medical professionals. And we believe that these challenges, given the nature of COVID, were more impactful in our clinical trials in the areas of pulmonary and critical care. We started screening patients for the TORI study in December 2020. Prior to the full effect of the Delta variant in the US and Western Europe, we experienced meaningful uptake in screening and enrollment this spring and through the mid-summer, and we leveraged many of our learnings with COVID from our completed Phase 1b trial.

We started screening patients for the Tory study in December 2020.

Prior to the full effect of the Delta variant in the U S and Western Europe, we experienced a meaningful uptick in screening and enrollment.

This spring and through the mid summer and we leverage many of our learnings with Covid from our completed phase one b trial.

At the time of our second quarter call on August seven we were confident of meeting expected, especially with the uptake in both screening and enrollment at U S based sites.

However, with the emergence of the Delta variant many of our investigators and nurses were called back into the Covid ICU wards in mid August and September and further lockdowns on national regional and municipal levels created an additional obstacle and enrollment in many locations throughout the western world essentially grounds in the hall.

Moreover, we also experienced competition from Covid related trials, specifically pediatric and booster vaccine work as well as from some of the Covid antibody and therapeutic trials.

Faheem Hasnain: At the time of our second quarter call on August 7th, we were confident in meeting expected timelines, especially with the uptake in both screening and enrollment at U.S. based sites. However, with the emergence of the Delta variant, many of our investigators and nurses were called back into COVID ICU wards in mid-August. Further lockdowns on national, regional, and municipal levels created an additional obstacle, and enrollment in many locations throughout the western world essentially ground to a halt.

I'm pleased to say now that the delta appears to be passing we're seeing increased engagement with sites and investigators they've gone back to their non Covid research and clinical programs and we're actively working to translate that into screening and enrollment.

Remember, we first encountered Covid COVID-19 based enrollment obstacles in the phase one study while getting patients enrolled remains an issue. Once on study. We have designed the study protocol with Covid and mine and will be there.

<unk> incorporated measures to keep patients on them once they're enrolled.

Despite COVID-19.

Of those patients that have already completed the 24 week Tory phase two.

Faheem Hasnain: Moreover, we also experienced competition from COVID-related trials, specifically pediatric and booster vaccine work, as well as from some of the COVID antibody and therapeutic trials. I'm pleased to say now that the Delta appears to be passing, we're seeing increased engagement with sites and investigators as they've gone back to their non-COVID research and clinical programs, and we're actively working to translate that into screens and enrollment. Remember, we first encountered COVID-based enrollment obstacles in the Phase 1b study.

All had enrolled into the OLED.

With nearly all of our 70 plus sites online and engaged we're confident we can continue to navigate these challenges to complete enrolment in the first half of next year and readout top line data.

Second half of 2022.

Now moving onto GB for.

We are extremely pleased today to announce that last month, we completed enrollment for the shift you see phase II study in mild to moderate ulcerative colitis colitis patients with active disease.

We were able to enroll this group of patients despite the pandemic for a number of reasons.

Oh fourth mechanism of action is distinct from systemic immune suppression and with Covid, a real concern for investigators and patients alike. G. D. O O four became an attractive option for those institutions focused on clinical trial and inflammatory bowel disease.

Faheem Hasnain: While getting patients enrolled remains an issue, once on study, we have designed the study protocol with COVID in mind, and we've incorporated measures to keep patients on study once they're enrolled. Despite COVID, of those patients that have already completed the 24-week TORI phase 2, all have enrolled into the OLE. With nearly all of our 70-plus sites online and engaged, we're confident that we can continue to navigate these challenges to complete enrollment in the first half of next year and read out top-line data in the second half of 2020.

We believe this also speaks well to the target positioning of G. D O for many solving ulcerative colitis commercial landscape patients with severe UC are inundated with treatment options that are lacking on the safety and Tolerability perspective.

The mild to moderate UC patients, who L. A S. A's are hesitant to make the jump to biologics in immuno and immunosuppressive therapies. This dynamic is buttressed G. B O four trial enrollment enrollment throughout Covid, and we believe it bodes well for the commercial potential of the molecule.

Additionally, the contributions from many capable team members, including from the legacy receptors that amati were instrumental in building, our global clinical trial infrastructure, leveraging longstanding relationships and positioning this trial for successful enrollment.

The primary endpoint of this trial is clinical remission. After 12 weeks, one salt patients complete 12 weeks.

Faheem Hasnain: Now, moving on to GB004, we are extremely pleased today to announce that last month we completed enrollment for the SHIFT-UC Phase 2 study in mild to moderate ulcerative colitis patients with active disease. We were able to enroll this group of patients despite the pandemic for a number of reasons. Gb004's mechanism of action is distinct from systemic immunosuppressants, and with COVID a real concern for investigators and patients alike, Gb004 became an attractive option for those institutions focused on clinical trials in inflammatory valve disease. We believe this also speaks well to the target positioning of Gb004 in an evolving ulcerative colitis commercial market.

And an additional month of safety monitoring we expect to announce top line results early in the second quarter of 2022.

After the 12 week primary endpoint patients will stay on randomized therapy for an additional 24 weeks. After completion of 36 weeks of randomized therapy, we expect to announce the results of the 36 week treat through end points in the fourth quarter of 2022.

Following completion of the trial patients will be presented with the option to enroll in our open label extension study, where we hope to generate longer term data.

Now before I ask Brian to run through the financial results for the quarter I wanted to remind listeners today Gutzmer recently unveiled its next clinical stage product candidate <unk>.

There are CNS penetrant PTK inhibitors, known as GBP, 50, 121, and GB 72, OE OE.

Faheem Hasnain: Patients with severe UC are inundated with treatment options that are lacking. Safety and Tolerability Perspectives, mild to moderate UC patients who fail 5-ASA are hesitant to make the jump to biologics and immunosuppressive therapy. This dynamic has buttressed GBO4 trial enrollment throughout COVID, and we believe it bodes well for the commercial potential of the model. Additionally...

These candidates are the product of intensive behind the scenes and internal development work.

We believe that these molecules have differentiated properties, including superior brain penetration that position the candidates to treat neuro inflammatory and narrow degenerative conditions in oncology and autoimmune diseases, including primary CNS lymphoma and multiple sclerosis.

And we're also pleased today to announce that we have dosed, our first subject with $51 21, GB 50, 121, and a phase one trial in healthy volunteers this month.

We expect to initiate a potentially registrational phase one b slash two trial in the first half of next year.

Faheem Hasnain: The contributions from many capable team members, including from the legacy receptus of Zanamath, We're instrumental in building a global clinical trial infrastructure, leveraging longstanding relationships, and positioning this trial for successful enrollment. The primary endpoint of this trial is clinical remission after 12 weeks. Once all patients complete 12 weeks and an additional month of safety monitoring, we expect to announce top-line results early in the second quarter of 2022. After the 12-week primary endpoint, patients will stay on randomized therapy for an additional 24 weeks.

G. B 72 O eight is expected to enter our first in human clinical trial in the second half of next year. Please.

Please visit our website at Gossamer bio dot com to see a recent investor day presentation that details both of these candidates and our development plans.

I'll now turn it back to Brian.

Thank you for him we will now review the financial results for the third quarter of 2021, we ended the quarter with $366 million of cash and cash equivalents, we anticipate our cash cash equivalents and marketable securities along with our access to our debt facility to provide us sufficient capital resources to fund operations and capital expenditures.

Into the second half of 2023.

Research and development expenses in the third quarter of 2021 were approximately $43 3 million as compared to R&D expenses of $41 8 million the same period in 2020 Jean.

G&A expenses were $12 $5 million in the third quarter as compared to G&A expenses of $11 $4 million for the same period in 2020.

Faheem Hasnain: After completion of 36 weeks of randomized therapy, we expect to announce the results of the 36-week treat-through endpoint in the fourth quarter of 2022. Additionally, following completion of the trial, patients will be presented with the option to enroll in our open-label extension study, where we hope to generate longer-term data. Now, before I ask Bryan to run through the financial results for the quarter, I wanted to remind listeners today that Gossamer recently unveiled its next clinical stage product candidate, a pair of CNS penetrant BTK inhibitors known as GB5121 and GB7208.

And our net loss for the quarter was $60 2 million equating to <unk> 80 per share.

For the same period in 2020 reported a net loss of 57 $8 million, which also equate to 80 cents a share with that ill turn the call back over to the heme prior to Q&A.

Thanks, Brian.

Just like to give my thanks to the gossamer team for their incredible passion and commitment towards making a difference for patients and I'd like to thank all of you for joining US today, we're excited to share our progress.

Operator.

Now open the line for questions.

Great.

As a reminder to ask a question you will need to press star one on your telephone once again, you will need to press star one on your telephone to consider our your question press the pound key please standby, while we compile the Q&A roster.

Your first question comes from the line of Natalie.

Your line is open.

I think hey, Brian. Thank you so much for saying all the updates, but I have two questions for you and maybe the first one is in regards to quite steady.

Faheem Hasnain: These candidates are the product of intensive behind-the-scenes and internal development. We believe that these molecules have differentiated properties, including Superior Brain Penetration that positions them to treat neuroinflammatory and neurodegenerative conditions in oncology and autoimmune disease, including primary CNS lymphoma and multiple sclerosis.

I know you've noticed that about 100% of the patients enrolled into the open label can you provide me with how many patients that are <unk>.

Open label and then are you planning on to turn on additional sites. So that topline data is on track the second half of 2022.

And then the second question is around ship to U C.

Have you maybe commented on sort of the statistical hierarchy in regards to the secondary endpoint.

Faheem Hasnain: And we're also pleased today to announce that we have dosed our first subject with Gb5121 in a phase one trial in healthy volunteers this month. We expect to initiate a potentially registrational Phase 1b-2 trial in the first half of next year. GB7208 is expected to enter a first-in-human clinical trial in the second half of next year. Please visit our website at gossamerbio.com to see a recent Investor Day presentation that details both of these candidates and our development plan. I'll now turn it back to Bryan. Thank you, Faheem.

As we think about clinical response in your coastal healing that you could provide some color around that could be very helpful. And thank you for taking my question.

Yes. It has been faheem. Thanks, Thanks very much for your question as it relates to the number of patients that are into OLED.

I'm sure you're aware, we don't comment on the specific numbers.

<unk> enrolled or and certainly the patients until early having said that.

We're pleased with the progress that we're now starting to see an enrollment and the fact that all of the patients that have been enrolled have gone until early.

It is an early encouraging sign.

As it relates to the.

The U C sorry.

It was the number of sites.

We have.

As we said in our.

Remarks.

Almost all of our 70 sites are.

Bryan Giraudo: We will now review the financial results for the third quarter of 2021. We entered the quarter with $366 million in cash and cash equivalents. We anticipate our cash, cash equivalents, and marketable securities, along with our access to our debt facility, to provide us sufficient capital resources to fund operations and capital expenditures well into the second half of 2023.

Either up and running or on the verge of reopening due to COVID-19 issues. Obviously that is the variable, but we feel very good that with the sites that are online onboard that we will be able to deliver the results and the timing that'll be put forth again subject to meaningful changes in the COVID-19 landscape.

And the AUC question, I'll turn that over to Richardson.

Sure.

Secondary endpoints in our shift you see steady.

Involve clinical response endoscopic improvement are healing and mucosal healing and our study is.

Appropriately powered to also achieve.

Those end points.

Speaker: Research and Development Expenses in the Third Quarter of 2021

Thank you team.

Sure.

Your next question comes from the line of Chi.

Joseph Schwartz your line is open.

Speaker: All in all, 2021 was approximately $43.2 million dollars, as compared to R&D expenses of $41.8 million dollars in the same period in 2020.

Alright, thanks very much.

It looks like your expectation of being able to report topline data from Tory in the second half of 2022 is still subject to the extent of potential ongoing COVID-19 disruption. So I was wondering if you can characterize how much of a stretch the second half of 'twenty two could be and as part of that question if enrollment.

Speaker: G&A expenses were $12.5 million in the third quarter as compared to $11.4 million.

Continues at the same rate as it has been most recently.

That put the data released within the second half of 'twenty, two and then I have a follow up.

As it relates to 2022 I mean, we are.

Speaker: $11.4 million for the same period in 2020. And our net loss for the quarter was $60.2 million, equating to $0.80 per share. For the same period in 2020, we reported a net loss of $57.8 million, which also equated to $0.80 per share.

We're again, we're encouraged by the rate of enrollment that we're seeing today, but Joseph I think we absolutely have to continue to put that COVID-19 asterisk on.

And that while we are seeing declining rates of of Delta hopefully, we don't see the next variant or a resurgence. So again I think it's only prudent to for us to continue to apply that COVID-19 asterisks until until we can kind of get to the other side of it.

Where we're at with the pandemic, Yes, I would just say Joe you know at the end of the day.

<unk> put out the guidance if we didn't believe we could hit it.

But as Faheem said.

Faheem Hasnain: With that, I'll turn the call back over to Faheem prior to Q&A. Thanks, Bryan. I'd just like to give my thanks to the Gossamer team for their incredible passion and commitment towards making a difference for patients. And I'd like to thank all of you for joining us today. We're excited to share our progress with you. Operator, you can now open the line for questions.

As we sat in the same conference from here at Gossamer a quarter ago. We thought we were going to hit the end of the year and we.

Merely did not expect the ferocity of Delta and what it did to again just the practice of medicine in pulmonary and critical care. So ultimately we certainly have the plan the people the infrastructure to do that there is a variable that's beyond our control that got us to the back end of the summer and our fingers are crossed that we won't.

Have that happen again.

But obviously, our forecasting and projections based on where we are today, we believe that thats, a pretty reasonable guidance.

Operator: All right, as a reminder, to ask a question, you will need to press star one on your telephone. Once again, you will need to press star one on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Your first question comes from the line of Yasmeen Rahimi. Your line is open.

Okay. That's helpful. Thank you and then have you considered doing an interim analysis for the Tory study.

Or how about some protocol amendments to simplify things such as perhaps making the PV are undertaking a sub study.

That's the main limiting factor for example, and a six minute walk study could be more alone could be more straightforward.

Yasmeen Rahimi: Hi Faheem. Hi Bryan.

Yes.

Yasmeen Rahimi: Thank you so much for sharing all the updates with us. I have two questions for you. Maybe the first one is in regards to the Torrey Study. I know you noted that about 100% of the patients enrolled in the open label. Can you provide me with how many patients that have entered open label? And then are you planning on to turn on additional sites so that top line data is on track for the second half of 2022?

This is Richard we've designed the study.

As a reminder, we've had some experience with ph patients from our phase <unk>.

In the setting of Covid. So we had that several lessons learned from that study and hence we designed our phase II from the get go if you will with certain provisions and mine to allow for some flexibility without.

Compromising the integrity or quality of the study.

Typical phase II program, it's important for PS VR, because you wanted to demonstrate hemodynamic changes and actually the sample size requirement for our PBR endpoint is much more relaxed if you will than a six minute walk endpoint.

Yasmeen Rahimi: And then the second question is around SHIFT-UC. Have you maybe commented on sort of the statistical hierarchy in regards to the secondary endpoints as we think about clinical response and mucosal healing? So if you could provide some color around that, it would be very helpful. And thank you for taking my question.

We feel that the way the study is currently designed.

We do not plan or to do an interim analysis.

That was not.

Something that we are planning to do.

And Joe I'll, just add that again.

Faheem Hasnain: Yasmeen, this is Faheem. Thanks very much for your question. As it relates to the number of patients that are into OLE, as I'm sure you're aware, we don't comment on the specific numbers of patients enrolled or, and certainly, patients into OLE. Having said that, you know, we're pleased with the progress that we're now starting to see in enrollment. And the fact that all of the patients that have been enrolled have gone into OLE is an early encourager as it relates to the...

The components of the Tory study were not what impeded enrollment it was the fact that.

Literally.

Many of our investigators got called to work in ICU Awards.

All of the management team has been out visiting with our investigators and more often that we hear we have patients. We just don't have nurses.

So it really has to do with just what's going on at <unk>.

Again pulmonary critical care centers of excellence around the world are struggling and we're struggling with Covid. We do think that that is starting to lift and we're seeing that engagement, but really not about torrey more about just the infrastructure treating patients on a macro basis.

Speaker: We have, as we said in our remarks, almost all of our 70 sites are either up or down.

Right. Okay. That's super helpful. Thanks for the color.

Speaker: We're open, running, or on the verge of reopening due to COVID issues. Obviously, that is the variable, but we feel very good that with the sites that are online.

Your next question comes from the line of Carter Copeland Your line is open.

Great. Good afternoon. Thanks for taking the question I guess to start it would be helpful. If you could just comment even at a high level around I guess your satisfaction with the homogeneity of the population you enrolled and shift do you see it seems like you were clearly the beneficiary of differentiated positioning in the marketplace and so even.

Speaker: and many more online agree that we will be able to deliver the results and the timing that we put forth again, subject to meaningful changes in the COVID landscape.

Even at a high level of any comments on that front would be it would be helpful. And then just given some of the setbacks that have.

Richard Aranda: and the UC question. I'll turn that over to Richard to give you some thoughts. Sure, the secondary endpoints in our SHIFT-GC study involve clinical response, endoscopic improvement, or healing, and mucosal healing. And our study is appropriately powered to also achieve those endpoints.

I guess the set some of your oral competitors in the UC landscape, if thats I guess.

Changed any any of your viewpoint, if you think about.

That moderate to severe population going forward I recognize the early efforts right in mild to moderate but.

Speaker: Thank you, team, for us.

Joseph Patrick Schwartz: Your next question comes from the line of Joseph Schwartz. Your line is open.

The landscape around you has sort of shifted no pun intended.

Yes, certainly as it relates to the landscape.

Joseph Patrick Schwartz: Hi, thanks very much. It looks like your expectation of being able to report top-line data from TORI in the second half of 2022 is still subject to... (inaudible)

You see Youre absolutely right. There is definitely some shifting that is occurring and.

While we're in a very interesting position in this.

Mild to moderate segment and given the pace of enrollment I think it's a.

Faheem Hasnain: and Then I have a follow-up.

A reasonable view to the attractiveness of the profile of this drug.

Faheem Hasnain: As it relates to 2022, I mean, we're again encouraged by the rate of enrollment that we're seeing today, but, you know, Joseph, I think we absolutely have to continue to put that COVID asterisk on the plan so that, while we're seeing declining rates of Delta, you know, hopefully, we don't see the next variant or resurgence. So, again, I think it's only prudent for us to continue to apply that COVID asterisk until we can kind of get to the other side of where we are with the pandemic.

Clearly we would.

Have the opportunity to be able to move not only earlier in therapy, but possibly even up later in therapy and potentially if the safety continues to play out view this as an opportunity to try to really change your emission rates by through through combination use.

I think the profile of this drug is just didnt make more attractive quite frankly with the cloud that fits around now safety associated with David.

The JAK class as an example, so I think thats.

All of that speaks to a bit of a tailwind to this program.

Yes in terms of the patient population.

We designed it to target a population mild to moderate.

Based on Mayo score and with it and discussing sub score of team.

We.

We will have to wait until we get the top line results first half of next year to figure out the full demographics, but.

Bryan Giraudo: I would just say, Joe, at the end of the day, we wouldn't have put out the guidance if we didn't believe we could hit it. But as Faheem said, as we sat in the same conference room here at Gossamer a quarter ago, we thought we were going to hit it at the end of the year.

Based on what.

Our enrollment.

Characteristics have been we're confident that we've targeted the right population.

Thank you.

Okay.

Alright next question comes from Baird. Your line is now open.

Hi, guys. Thanks for the questions I wanted to ask on your latest expectations for efficacy measures in the Tory study and I know you've talked about wanting to see similar PD or reduction so tighter sat in and I think that was you know 18% to 32% range in and then also on now on six minute walk in that 20 to 30 meter improvement at least directionally. So.

Bryan Giraudo: And we clearly did not expect such ferocity.

Speaker: of Delta and what it did to, again, just the practice of medicine.

Speaker: Pulmonary and Critical Care. So ultimately, you know, we certainly have the plan, the people, and the infrastructure to do that.

Is that still the bar you're looking ahead or are there any updates on how youre thinking about that readout and then I've got follow up on that.

Speaker: There is a variable that is beyond our control that got us to the back end of the summer, and our fingers are crossed that we won't have that happen again.

We're still.

Believe that those are the right guidepost for what we want to see and hence there's been no no changes in our thought process.

Speaker: But obviously, you know, our forecasting and projections based on where we are today; we believe that's a pretty reasonable guide.

Okay got it and then on O four.

I know you guys talked a little bit about the landscape earlier, but there are still a number of oral is in development and there could be more than one.

Oral modality on the market.

Joseph Patrick Schwartz: Okay, that's helpful. Thank you. And then, have you considered doing an intermediate?

By the time you all kept minister development. So I guess the question is how do you think about the possible treatment hierarchy for those different oral agents and where do you think oh for it can be most differentiated there.

Joseph Patrick Schwartz: [inaudible]

Richard Aranda: Could be more alone, could be more straightforward. Yeah, we've, this is Richard. We've designed the study. As a reminder, we've had some experience with PH patients from our Phase 1B study in the setting of COVID, so we added several lessons learned from that study. And hence, we designed our Phase 2 from the get-go, if you will, with certain provisions in mind to allow for some flexibility without compromising the integrity or quality of the study.

So as we know.

Unfortunately, none of these none of these treatments are can be viewed as cures and like many other autoimmune indications patient.

Cycle through through treatment so.

The availability of a number of treatment choices that have kind of a patient friendly attribute of being an oral daily daily oral I think is incredibly attractive the market is pretty large so I think thats kind of the first dimension is that a number of oil on the market I think is great for patients.

But also there is plenty of room in that context, I think the second dimension here is the positioning that we see the first level of positioning and that kind of mild to moderate segment that hosts five assay failure pre immuno suppressant pre pre biologic, that's a very unique positioning that.

Richard Aranda: A typical Phase 2 program; it's important for PVR because you want to demonstrate hemodynamic changes. And actually, the sample size requirement for a PVR endpoint is much more relaxed, if you will, than a six-minute walk-in point. We feel that the way the study is currently designed, we do not plan to do an interim analysis, and that is not something that we are planning to do. And Joe, I just want to add that again.

Doesn't have the same kind of.

Oral comp competition, so to speak in other words, as Ana Mod, which drug we know well really doesn't play in that space of course.

As noted the jacks. So I think there is a very unique element of profile for this drug that I think both.

Well for the future assuming that the data plays out.

Great. Thank you guys.

Your next question comes from Patrick Kim Your line is open.

Speaker: The components of the TORI study were not what impeded enrollment; it was the fact that, literally, many of our investigators got called to work in ICU wards. All of the management team has been out visiting with our investigators. More often than not, we hear, we have patients. We just don't have enough nurses. So it really has to do with just what's going on at, again, pulmonary and critical care centers of excellence around the world are struggling, and we're struggling with COVID. We do think that that is starting to lift, and we're seeing that engagement, but really not about TORI, more about just the infrastructure of treating patients on a macro-based basis.

Hi, Thank you for taking my question and this is Jason speaking for Patrick and so I guess I just have a two part question about the GB PTK inhibitors.

First question is what is your expected pace of enrolment for your GBP 501 to one and possibly if you can give us some insight on your future study for GBP 7208.

And the second question is what is your primary end point for your first in human study for your GPU 15121, and thank you.

Yes so.

As mentioned, we're currently conducting a normal healthy volunteer study.

Our primary endpoint is typically for normal healthy volunteers and safety Tolerability, we'll obviously look at.

Pharmacokinetics.

And the nice thing about PTK inhibitors. There is a lot of science behind target engagement biomarker, so and receptor occupancy. So we'll we'll also assess those.

Joseph Patrick Schwartz: Right, okay, that's super helpful. Thanks for the color.

Your question for Lamar was around these column.

Yeah.

Carter Lewis Gould: Your next question comes from the line of Carter Gould. Your line is open.

Its normal healthy volunteer so typically they're done.

Phase one units where patients are identified.

Carter Lewis Gould: Great. Good afternoon.

And screamed and putting Q, so we anticipate that.

Faheem Hasnain: Thanks for taking the question. I guess to start, it'd be helpful if you could just comment, even at a high level, on your satisfaction with the homogeneity of the population you enrolled in SHIFT-UC. It seems like you were clearly the beneficiary of differentiated positioning in the marketplace. And so, even at a high level, any comments on that front would be helpful. And then just given some of the setbacks that have, I guess, beset some of your oral competitors in the UC landscape, if that's, I guess, changed any of your viewpoints as you think about that moderate to severe population going forward. I recognize the early efforts were on mild to moderate, but, you know, the landscape around you has sort of shifted, no pun intended. Thank you.

It would go.

Relatively.

Quickly.

Thank you.

And then I think you had a question.

I think you had a question about <unk>.

72, Oh wait.

It's.

We anticipate also doing a first in human normal healthy volunteer given that it's a BT K will likely have a similar trial design as our current normal healthy volunteer with $61 21.

Alright, Thank you very much.

Your next your next question comes from Brian Chen Your line is open.

Hey, guys. Thanks for taking my question. So maybe first one on <unk> 50, 121, I'm just curious if you have any early thoughts on.

The inclusion or exclusion criteria for RPC NFL.

Some other PTK inhibitor for this indication.

And are you going to be including are you planning to include patients. So that's.

Intra ocular CSF in Boston, and then I have one.

Faheem Hasnain: Yeah, certainly, as it relates to the landscape of UC, you're absolutely right; there's definitely some shifting that is occurring. And, and while we're in a very interesting position in this mild to moderate segment, And given the pace of enrollment, I think it's a reasonable view of the attractiveness of the profile of this drug. I think clearly we would have the opportunity to move not only earlier in therapy but possibly even later in therapy.

One quick follow up.

So.

Yes.

We are going to include patients with intraocular and CSS.

<unk>, obviously, we're going to roll patients.

That have refractory.

Or recurrent primary and secondary CNS lymphoma as our initial.

The patient population in our dose escalation once we define a.

Recommended phase II dose, we will then focus on RFP CNS Ah patient population.

Faheem Hasnain: And potentially, if the safety continues to play out, view this as an opportunity to try to really change remission rates through combination use. I think the profile of this drug has just been made more attractive, quite frankly, with the cloud that sits around now about safety associated with, say, the JAK class as an example. So I think that all of that speaks to a bit of a tailwind for this program. In terms of the patient population, you know, we designed it to target a population mild to moderate based on the Mayo score and with an endoscopic subscore of two.

As part of our <unk>.

<unk> two study and then as part of a dose expansion.

Sure.

Component.

Okay, and maybe on back on sorry, I learned that I'm, just wondering if what you're getting additional L E updates for the.

The compound from the phase <unk> study in near term given that we saw that two patients update.

Last quarter and I'm, just and also I'm curious if you have any if you start looking into any signs of vascular remodeling, alright, hemodynamics and dose two patients. Thanks.

Yes, so as you recall, we had two patients complete.

The open label extension of the Phase one b.

Faheem Hasnain: You know, we'll have to wait till we get the top line results in the first half of next year to figure out the full demographics, but based on what our enrollment and characteristics have been, we're confident that we've targeted the right population.

One of those patients still continues.

In a open label experience as well.

We have another protocol that this patient rolled over in there.

They continue to do well.

The other patient decided to go onto another trial.

And therefore did not go forward in the open label extension of several Loopnet in terms of vascular remodeling, we did not.

Olivia Brayer: Your next question comes from Olivia Brayer. Your line is open.

Specifically.

Olivia Brayer: Hi guys. Thanks for the questions. I wanted to ask you about your latest expectations for efficacy measures in the TORI study. I know you've talked about wanting to see some more PVR reduction, so tatter sats, and I think that was, you know, the 18 to 32 percent range. And then also on the six-minute walk and that 20 to 30 meter improvement, at least directionally. Is that still the bar you're looking ahead at, or are there any updates to how you're thinking about that readout? And then I've got a follow-up on Yushi.

Have any assessments of that it's difficult. So the only thing we do have as for example, indirect measures such as anti pro BNP and obviously six minute walk that we're continuing to follow.

Okay. Thank you.

I am showing no further questions at this time please continue.

Alright, so there is no further questions.

Thank everybody for spending time with us today and again my thanks to the team and thanks to all patients.

<unk> is enrolled in the trial, we look forward to next quarter.

Being able to continue to give you updates on progress.

Thanks, everybody.

This concludes today's conference call. Thank you for participating you may now disconnect.

Speaker: We still believe that those are the right guideposts for what we want to see, and hence, there have been no changes in our thought process.

Okay.

[music].

Speaker: Okay, got it. And then on O4, you know, I know you guys talked a little bit about the landscape earlier, but there are still a number of orals in development. And by the time your asset moves through development, there could be more than one oral modality on the market. So I guess the question is, how do you think about the possible treatment hierarchy for those different oral agents? And, and where do you think O4 could be most differentiated there? So, as we know,

Yes.

[music].

Okay.

Correct.

Okay.

Yes.

[music].

Okay.

Sure.

[music].

Okay.

Sure.

[music].

Speaker: So, as we know, unfortunately, none of these treatments are going to be viewed as cures. And like many other autoimmune indications, patients often cycle through treatments. So the availability of a number of treatment choices that have the patient-friendly attribute of being an oral, daily oral, I think is incredibly attractive. The market is pretty large.

Okay.

Speaker: So I think that's kind of the first dimension, that there are a number of orals on the market which is great for patients, but also, there's plenty of room in that context. I think the second dimension here is the positioning that, at least, the first level of positioning in that kind of mild to moderate segment, that post 5-ASA failure, pre-immunosuppressant, pre-biologic, that's a very unique positioning that doesn't have the same kind of oral competition, so to speak.

Okay.

[music].

Speaker: In other words, Ozanamide, which is a drug we know well, really doesn't play in that space, of course, nor does JAX. So I think there's a very unique element of profile for this drug that I think bodes well for the future, assuming that the data is there.

Patrick Ralph Trucchio: Your next question comes from Patrick Trucchio. Your line is open.

Jason: Hi. Thank you for taking my question. And this is Jason speaking on behalf of Patrick.

Jason: And so I guess I just have a two-part question about the GB BTK inhibitors. And so the first question is, what is your expected pace of enrollment for your GB5121 study and, possibly, if you can give us some insight on your future study for GB7208. And the second question is, what is your primary endpoint for your first in human study for your GB5121? And thank you.

Speaker: Yeah, so as mentioned, we're currently conducting a normal healthy volunteer study. Our primary point is, typically, safety tolerability. We'll obviously look at and Pharmacokinetics. And the nice thing about BTK inhibitors, there's a lot of science behind target engagement biomarkers, so receptor occupancy, so we'll also assess those. Your question, furthermore, was around based on. Yeah, it's, you know, it's normal healthy volunteers. So typically, they're done in phase one units where patients are identified, and screened, and put in a queue, so we anticipate that it would go relatively quickly, and then I think you had a question about 7208. We anticipate also doing a first in human normal healthy volunteers; given that it's a BPK, we'll likely have a similar trial design.

[music].

Bryan Giraudo: Your next question comes from Bryan Chang. Your line is open. Hey guys.

Bryan Giraudo: Hey guys, thanks for taking my question. So maybe the first one on GBE5121, I'm just curious if you have any early thoughts on the inclusion or exclusion criteria for PCNSL using learnings from other BTK inhibitors for this indication and whether you are going to be including, are you planning to include patients with, you know, intraocular or CSF involvement. And then I have one quick follow-up. So, yes, we are going to include patients with intraocular and CSF involvement.

Bryan Giraudo: Obviously, we're going to enroll patients that have refractory or recurrent primary and secondary CNS lymphoma as our initial patient population in our dose escalation phase. Once we define a recommended phase two dose, we will then focus on our PCNS patient population as part of our Phase II study and then as part of a dose expansion component.

Speaker: And maybe back on Sarah Lunib, I'm just wondering if we would be getting additional OLE updates for the compound from the Phase 1b study near term, given that we saw the two patients update last quarter. And I'm just, and also I'm curious if you have any, if you've started looking into any signs of vascular remodeling or hemodynamics in those two patients. Thanks.

Speaker: Yeah, so as you recall, we had two patients complete the open label extension of phase 1B. One of those patients still continues in an open label experience as we have another protocol that this patient rolled over into. They continue to do well. The other patient decided to go on to another trial and therefore did not go forward with the open-label extension of serolutinib. In terms of vascular remodeling, we did not specifically have any assessments of that. It's difficult. So the only thing we do have is, for example, indirect measures such as NT Pro BMP and obviously the six minute walk that we're continuing to follow.

Operator: I am showing no further questions at this time. Please continue.

Speaker: All right, if there are no further questions, we thank everybody for spending time with us today. And again, my thanks to the team and thanks to all the patients that have enrolled in the trials. We look forward to next quarter being able to continue to give you updates on progress. Thanks, everybody.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.

Operator: © BF-WATCH TV 2021 ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Music Music Music Music Music Music Music Music Music Music Music, ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?? ?? ?? ?? ?? ?? ?? ??

Operator: Good day, and thank you for standing by. Welcome to the Gossamer Bio Q3 earnings call.

Bryan Giraudo: 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. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Mr. Bryan Giraudo, Financial and Chief Operating Officer. Thank you.

[music].

Speaker: Thank you, Operator, and thank you all for joining us this afternoon. I am joined on today's call by Gossamer Bio's Chairman, Co-Founder, and Chief Executive Officer Faheem Hasnain, Laura Carter, Gossamer Bio's Chief Scientific Officer, and Richard Aranda, Gossamer Bio's Chief Medical Officer. Earlier this afternoon, Gossamer Bio issued a press release announcing its financial results for the third quarter ended September 3, 2021, in addition to providing a corporate update. Please note that certain information discussed on this call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act.

Speaker: 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 four forward-looking statements are qualified by the Statements Committee.

Bryan Giraudo: and Gossamer's news releases and SEC filings, including in the annual report on Form 10-K and subsequent filings. This conference call also contains time-sensitive information that may be accurate only for a limited period of time. Our ability to meet our guidance, especially that related to the timely initiation and completion of clinical studies, in addition to our ability to release results from our clinical trials in a timely manner, may be adversely affected by the ongoing COVID-19 pandemic. Gossamer Bio undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. Now, I'd like to turn the call over to Faheem. Thanks, Bryan.

Faheem Hasnain: And thank you all for joining us today on Gossamer Bio's third quarter earnings and update call. At the end of today's call, we'll conduct a question and answer session. But first, we will discuss our inhaled kinase inhibitor for the treatment of pulmonary arterial hypertension. [Inaudible] In the press release we issued earlier today, we shifted our guidance for the top-line data readout for the TORI Phase 2 study of serolutinib to the second half of 2022.

Faheem Hasnain: And, as I'm sure all of you are aware, the COVID-19 pandemic has created unprecedented challenges in conducting clinical trials, including a shortage of medical professionals. And we believe that these challenges, given the nature of COVID, were more impactful in our clinical trials in the areas of pulmonary and critical care. We started screening patients for the TORI study in December 2020. Prior to the full effect of the Delta variant in the U.S. and Western Europe, we experienced meaningful uptake in screening and enrollment this spring and through the midsummer.

[music].

Faheem Hasnain: And we leveraged many of our learnings with COVID from our completed Phase 1B trial. At the time of our second quarter call on August 7th, we were confident on meeting expected timelines, especially with the uptake in both screening and enrollment at US-based sites. However, with the emergence of the Delta variant, many of our investigators and nurses were called back into COVID ICU wards in mid-August. Further lockdowns on national, regional, and municipal levels created an additional obstacle, and enrollment in many locations throughout the western world essentially ground to a halt.

Faheem Hasnain: Moreover, we also experienced competition from COVID-related trials, specifically pediatric and booster vaccine work, as well as from some of the COVID antibody and therapeutic trials. I'm pleased to say, now that the Delta appears to be passing, we're seeing increased engagement with sites and investigators as they've gone back to their non-COVID research and clinical programs, and we're actively working to translate that into screenings and enrollment. Remember, we first encountered COVID-based enrollment obstacles in the Phase 1b study, while getting patients enrolled remains an issue.

Faheem Hasnain: Once on study, we have designed the study protocol with COVID in mind, and we've incorporated measures to keep patients on study once they're enrolled. Despite COVID, of those patients that have already completed the 24-week TORI phase 2, all have enrolled into the OLE. With nearly all of our 70-plus sites online and engaged, we're confident that we can continue to navigate these challenges to complete enrollment in the first half of next year and read out top-line data in the second half of 2020.

Yeah.

Good day, and thank you for standing by welcome to the Gossamer Bio Q3 earnings call.

Faheem Hasnain: We believe this also speaks well to the target positioning of Gb004 in an evolving ulcerative colitis commercial landscape. Patients with severe UC are inundated with treatment options that are lacking. Safety and Tolerability Perspectives, mild to moderate UC patients who fail 5-ASA are hesitant to make the jump to biologics and immunosuppressive therapy.

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 to your user during the session you will need your breast star one on your telephone if you require any further assistance. Please press star zero.

I would now like to turn the conference over to your Speaker today, Mr. Bryant, Toronto financial and Chief operating Officer. Thank you. Please go ahead.

Faheem Hasnain: This dynamic has buttressed GBO for trial enrollment throughout COVID, and we believe it bodes well for the commercial potential of the molecule. Additionally, and contributions from many capable team members, including from the Legacy Receptus of Zanamoth, were instrumental in building a global clinical trial infrastructure, leveraging longstanding relationships, and positioning this trial for successful enrollment. The primary endpoint of this trial is clinical remission after 12 weeks. Once all patients complete 12 weeks and an additional month of safety monitoring, we expect to announce top-line results early in the second quarter of 2021. After the 12-week primary endpoint, patients will stay on randomized therapy for an additional 24 weeks.

S release announcing its financial results for the third quarter ended September 32021. In addition to providing a corporate update.

These business.

Faheem Hasnain: After completion of 36 weeks of randomized therapy, we expect to announce the results of the 36-week treat-through endpoint in the fourth quarter of 2022. Additionally, following completion of the trial, patients will be presented with the option to enroll in our open-label extension study, where we hope to generate longer-term data. Now, before I ask Bryan to run through the financial results of the quarter, I wanted to remind listeners today that Gossamer recently unveiled its next clinical stage product candidate, a pair of CNS penetrant DTK inhibitors known as GB5121 and GB7208.

Thanks, Brian.

Thank you all for joining us today, and Gossamer Bio's third quarter earnings and update call at the end of today's call. We will conduct a question and answer session.

But first we will discuss our inhaled kinase inhibitor for the treatment of pulmonary arterial hypertension, Sarah that nib.

In the press release, we issued earlier today, we shifted our guidance for the top line data readout, the maturing phase III study.

The second half of 2022.

And as I'm sure. All of you are aware the COVID-19 pandemic has created unprecedented challenges in conducting clinical trials, including the shortage of medical professional and we believe that these challenged given the nature of the Covid were more impactful for our clinical trials and here is a pulmonary and critical care.

Faheem Hasnain: These candidates are the product of intensive behind-the-scenes and internal development. We believe that these molecules have differentiated properties, including Superior Brain Penetration, that position them to treat neuroinflammatory and neurodegenerative conditions in oncology and autoimmune disease, including primary CNS lymphoma and multiple sclerosis.

We started screening patients for the Tory study in December 2020.

Prior to the full effect of the Delta variants in the U S and Western Europe, we experienced a meaningful uptick in screening and enrollment.

This spring and through the mid summer and we leverage many of our learnings with Covid from our completed phase one b trial.

At the time of our second quarter call on August seven we were confident in meeting expected timeline, especially with the uptick in both screening and enrollment at U S based sites.

However, with the emergence of the Delta variant many of our investigators nurses recalled back into these COVID-19 ICU wards in mid August and September and further lockdowns on national regional and municipal levels created an additional obstacle and enrollment in many locations throughout the western world essentially ground to a halt.

Faheem Hasnain: And we're also pleased today to announce that we have dosed our first subject with 51-21, GB51-21, in a Phase I trial in Healthy Volunteers this month. We expect to initiate a potentially registrational Phase 1b-2 trial in the first half of next year. GB7208 is expected to enter a first-in-human clinical trial in the second half of next year. Please visit our website at gossamerbio.com to see a recent Investor Day presentation that details both of these candidates and our development plan. I'll now turn it back to Bryan. Thank you, Faheem.

Moreover, we also experienced competition from Covid related trials, specifically pediatric and booster vaccine work as well as from some of the Covid antibody and therapeutic trials.

I'm pleased to say now that the delta appears to be passing we're seeing increased engagement with sites and investigators as they've gone back to their non Covid research and clinical programs and we are actively working to translate that into screening and enrollment.

Remember, we first encountered Covid covet base enrollment obstacles in the phase <unk> study, while getting patients enrolled remains an issue. One study we have designed the study protocol with Covid in mind, and we've incorporated measures to keep patients on them once they're enrolled.

Bryan Giraudo: We will now review the financial results for the third quarter of 2021. We entered the quarter with $366 million of cash and cash equivalents. We anticipate our cash, cash equivalents, and marketable securities, along with our access to our debt facility, to provide us sufficient capital resources to fund operations and capital expenditures well into the future.

Despite COVID-19.

Of those patients that have already completed the 24 week Tory phase III.

All had enrolled into the OLED.

With nearly all of our 70 plus sites online and engaged we're confident that we can continue to navigate these challenges to complete enrollment in the first half of next year and read out top line data in the second half of 2022.

Now moving on to <unk>.

We are extremely pleased today to announce that last month, we completed enrollment for the shift you see phase II study in mild to moderate ulcerative colitis colitis patients with active disease.

Speaker: the second half of 2023. Research and development expenses for the third quarter of 2021 were approximately $43 billion.

We were able to enroll this group of patients. Despite the pandemic for a number of reasons GB.

<unk> mechanism of action is distinct from systemic immunosuppressant and with Covid, a real concern for investigators and patients alike.

Speaker: $43.2 million, as compared to R&D expenses of $41.8 million in the same period in 2012.

All four became an attractive option for those institutions focused on clinical trial and inflammatory bowel disease.

Speaker: G&A expenses were $12.5 million in the third quarter as compared to $11.4 million for the same period in 2020. And our net loss for the quarter was $60.2 million, equating to $0.80 per share. For the same period in 2020, we reported a net loss of $57.8 million, which also equated to $0.80 per share.

We believe it also speaks well to the target positioning of <unk> four.

Evolving ulcerative colitis commercial landscape patients with severe UC are inundated with treatment options that are lacking on the safety and tolerability perspective, but mild to moderate UC patients who fail <unk>.

Days are hesitant to make the jump to biologics that an immunosuppressive therapies. This dynamic is buttressed CBO for trial and enrollment throughout Covid and we believe it bodes well for the commercial potential of the molecule.

Additionally, the contributions from many capable team members, including from the legacy receptive to Denmark team were instrumental in building, our global clinical trial infrastructure, leveraging longstanding relationships and positioning in this trial for successful enrollment.

Faheem Hasnain: With that, I'll turn the call back over to Faheem prior to Q&A. Thanks, Bryan. I'd just like to give my thanks to the Gossamer team for their incredible passion and commitment towards making a difference for patients. And I'd like to thank all of you for joining us today. We're excited to share our progress. Operator, you can now open the line for questions.

The primary endpoint of this trial is clinical remission after 12 weeks.

<unk> patients complete 12 weeks and an additional month of safety monitoring we expect to announce top line results early in the second quarter of 2022.

After the 12 week primary endpoint patients will stay on randomized therapy for an additional 24 weeks.

Yasmeen Rahimi: As a reminder, to ask a question, you will need to press star 1 on your telephone. Once again, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Your first question comes from the line of Yasmeen Rahimi. Your line is open.

After completion of 36 weeks of randomized therapy, we expect to announce the results of the 36 week treat through end points in the fourth quarter of 2022.

Following completion of the trial patients will be presented with the option to enroll in our open label extension study, where we hope to generate longer term data.

Now before I ask Brian to run through the financial results for the quarter I wanted to remind listeners today that gutzmer recently unveiled its next clinical stage product candidates a pair of CNS penetrant PTK inhibitors, known as GBP $51 21, and GBP 72, okay.

Yasmeen Rahimi: Hi Faheem, hi Bryan. Thank you so much for sharing all the updates with us. I have two questions for you. Perhaps the first one is in regards to the Torrey study. I know you noted that about 100% of the patients enrolled into the open label. Can you provide me with how many patients that have entered the open label? And then are you planning to turn on additional sites so that top line data is on track for the second half of 2022?

Yeah.

These candidates at a product of intensive behind the scenes and internal development work.

We believe that these molecules that differentiated properties, including superior brain penetration.

Transition to candidates to treat neuro inflammatory and narrow degenerative conditions in oncology and autoimmune diseases, including primary CNS lymphoma.

In multiple sclerosis.

And we're also pleased today to announce that we have dosed, our first subject with $51 21, GB 50, 121, and a phase one trial in healthy volunteers this month.

We expect to initiate a potentially registrational phase <unk> II trial in the first half of next year.

GBP 72, eight is expected to enter our first in human clinical trial in the second half of next year.

Visit our website at Gossamer bio dot com to see our recent Investor day presentation that details both of these candidates and our development plans.

I'll now turn it back to Brian.

Thank you we will now review the financial results for the third quarter of 2021, we ended the quarter with $366 million of cash and cash equivalents, we anticipate our cash cash equivalents and marketable securities along with our access to our debt facility to provide us sufficient capital resources to fund operations and capital expense.

<unk> well into the second half of 2023.

URL: https://www.kenhub.com

Research and development expenses in the third quarter of 2021 were approximately $43 3 million.

Speaker: running or on the verge of reopening due to COVID issues. Obviously, that is the very

As compared to R&D expenses up $41 8 million the same period in 2020.

G&A expenses were $12 5 million in the third quarter as compared to G&A expenses of $11 $4 million for the same period in 2020.

Speaker: That is the variable, but we feel very good that with the sites that...

Richard Aranda: and the UC question. I'll turn that over to Richard. The secondary endpoints in our SHIFT-GC study involve clinical response, endoscopic improvement or healing, and mucosal healing, and our study is appropriately powered to also achieve those endpoints.

And our net loss for the quarter was $60 2 million equating to <unk> 80 per share for.

For the same period in 2020, we reported a net loss of $57 8 million, which also equates to 80 cents a share.

With that I'll turn the call back over to the heme prior to Q&A.

Thanks, Brian.

Speaker: Thank you, team, for us.

Joseph Patrick Schwartz: Hi, thanks very much. It looks like your expectation of being able to...

As a reminder to ask a question you will need to press star one on your telephone once again, you will need to press star one on your telephone to visit our your question press the pound key.

Faheem Hasnain: And as part of that question, if enrollment continues at the same rate as it has been most recently, where would that put the data release within the second half of 22? And then I have a follow-up question. As it relates to 2022, I mean, we're again encouraged by the rate of enrollment that we're seeing today, but, you know, Joseph, I think we absolutely have to continue to put that COVID asterisk on the plan so that, while we're seeing declining rates of Delta, you know, hopefully, we don't see the next variant or resurgence. So, again, I think it's only prudent for us to continue to apply that COVID asterisk until we can kind of get to the other side of where we are with the pandemic.

Some by while we compile the Q&A roster.

Your first question comes from the line of Rahul.

Your line is open.

Hi, Tim Hi, Brian. Thank you so much for all the updates Madonna have two questions for you maybe the first one is in regards to Torrey study.

I know you noted that about 100% of the patients enrolled into the open label can you provide me with how many patients that are <unk>.

Open label and then are you planning on to turn on additional sites. So that topline data is on track for the second half of 2022.

And then the second question is around ship to U C.

Have you maybe commented on sort of the statistical hierarchy in regards to the secondary endpoint.

As we think about clinical response mucosal healing you could provide some color around that could be very helpful. And thank you for taking my question.

Yes, yes, it's been the same thanks, thanks very much for your question as it relates to the number of patients that are into OLED.

Im sure Youre aware, we don't comment on the specific numbers.

<unk> enrolled or and certainly patients into OLED, having said that.

Speaker: And we clearly did not expect the ferocity of Delta and what it would do.

We're pleased with the progress that we're now starting to see an enrollment and the fact that all of the patients that have been enrolled have gone until early.

Joseph Patrick Schwartz: [inaudible]

It is an early encouraging sign.

Speaker: We certainly have the plan, the people, and the infrastructure to do that.

As it relates to the.

<unk>.

The UC sorry.

There is the number of sites.

I mean, we have.

Speaker: There's a variable that's beyond our control that got us to the back end of the summer, and our fingers are crossed that we won't have that happen again.

As we said in our.

Remarks.

Almost all of our 70 sites are.

Either up and running or on the verge of reopening due to COVID-19 issues. Obviously that is the variable, but we feel very good that with the sites that are online onboard that we will be able to deliver the results of the timing now that we've put forth again subject to meaningful changes in the COVID-19 landscape.

Speaker: But obviously, you know, our forecasting and projections based on where we are today; we believe that's a pretty reasonable guide.

Joseph Patrick Schwartz: Okay, that's helpful. Thank you. And then, have you considered doing an interim analysis for the TORI study?

And the AUC question, I'll turn that over to Richardson.

Sure the secondary endpoints in our ship GC steady.

Joseph Patrick Schwartz: Or how about some protocol amendments to simplify things such as...

Involve clinical response endoscopic improvement are healing and mucosal healing and our study is.

Speaker: Dr. Robert Schwartz, Robert Schwartz, Dr. Robert Schwartz, Dr. Robert Schwartz

Appropriately powered to also achieve.

Those endpoints.

Thank you team.

Sure.

Your next question comes from the line of Joseph Schwartz. Your line is open.

Richard Aranda: Yeah, we've, this is Richard. We designed the study. As a reminder, we have had some experience with pH patients from our Phase 1B in the setting of COVID. So we had several lessons learned from that study, and hence we designed our Phase 2 from the get-go, if you will, with certain provisions in mind to allow for some flexibility without compromising the integrity or quality of the study. A typical Phase 2 program is important for PVR because you want to demonstrate hemodynamic changes, and actually, the sample size requirement for a PVR endpoint is much more relaxed, if you will, than a six-minute walk-

Alright, thanks very much.

Continues at the same rate as it has been most recently.

That put the data released within the second half of 'twenty, two and then I have a follow up.

As it relates to 2022 I mean, we are.

We're again, we're encouraged by the rate of enrollment that we're seeing today, but Joseph I think we absolutely have to continue to put that COVID-19 asterisk on plant and that while we are seeing declining rates.

Delta hopefully, we don't see the next variant or a resurgence. So again I think it's only prudent for us to continue to apply that COVID-19 asterisks until until we can kind of get to the other side of it.

Richard Aranda: We feel that the way the study is currently designed, we do not plan to do an interim analysis, and that was not something that we were planning to do. Joe, I just want to add that, again, the components of the TORI study were not what impeded enrollment. It was the fact that literally many of our investigators got called to work in ICU wards. All of the management team has been out visiting with our investigators, and more often than not, we hear, we have patients; we just don't have nurses.

Where we're at with the pandemic, Yes, I would just say Joe you know at the end of the day.

<unk> put out the guidance if we didn't believe we could hit it.

But as Faheem said.

As we sat in.

The same conference from here at Gossamer.

Argo, we felt we were going to hit the end of the year and we.

Clearly did not expect the ferocity of Delta and what it did to again just the practice of medicine in pulmonary and critical care. So ultimately we certainly have the plan the people the infrastructure to do that there is a variable that's beyond our control that got us to the back end of the summer and our fingers are crossed that we will.

Speaker: So, it really has to do with just what's going on at, you know, again, pulmonary and critical care centers of excellence around the world are struggling, and we're struggling with COVID. We do think that that is starting to lift, and we're seeing that engagement.

Have that happen again.

But obviously, our forecasting and projections based on where we are today, we believe that's a pretty reasonable guidance.

Okay. That's helpful. Thank you and then have you considered doing an interim analysis for the Tory study.

Or how about some protocol amendments to simplify things such as perhaps making the PBR undertaking a sub study.

Speaker: Thank you very much.

Speaker: Right, okay, that's super helpful. Thanks for the color.

That's the main limiting factor for example.

Carter Lewis Gould: Your next question comes from the line of Carter Gould. Your line is open.

Six minute walk study could be more alone could be more straightforward.

Yes.

Carter Lewis Gould: Great. Good afternoon.

This is Richard we've designed the study.

Faheem Hasnain: Thanks for taking the question. I guess to start, it'd be helpful if you could just comment, even at a high level, on your satisfaction with the homogeneity of the population you enrolled in SHIFT-UC. It seems like you were clearly the beneficiary of differentiated positioning in the marketplace. And so, even at a high level, any comments on that front would be helpful. And then just given some of the setbacks that have, I guess, beset some of your oral competitors in the UC landscape, if that's, I guess, changed any of your viewpoints as you think about that moderate to severe population going forward. I recognize the early efforts around mild to moderate, but, you know, the landscape around you has sort of shifted, no pun intended. Thank you.

As a reminder, we've had some experience with ph patients from our phase <unk>.

In the setting of Covid. So we had several lessons learned from that study and hence we designed our phase II from the get go if you will with certain provisions in mind to allow for some flexibility without.

Compromising the integrity or quality of the study.

Typical phase II program it is important for PCR.

You wanted to demonstrate hemodynamic changes and actually the sample size requirement for our PBR endpoint is much more relaxed if you will than a six minute walk endpoint.

We feel that the way the study is currently designed.

We do not plan or to do an interim analysis.

That was not.

Something that we are planning to do.

And Joe I'll, just add that again.

The components of the Tory study were not what impeded enrollment it was the fact that.

Faheem Hasnain: Yeah, certainly, as it relates to the landscape of UC, you're absolutely right; there's definitely some shifting that is occurring. And while we're in a very interesting position in this mild to moderate segment, and given the pace of enrollment, I think it's a reasonable view of the attractiveness of the profile of this drug. I think clearly, we would have the opportunity to be able to move not only earlier in therapy but possibly even later in therapy.

Literally.

Many of our investigators got called to work in ICU Awards.

All of the management team has been out visiting with our investigators.

More often that we hear we have patients we just don't have nurses.

So you can really has to do with just what's going on at.

Right. Okay. That's super helpful. Thanks for the color.

Your next question comes from the line of Carter Copeland Your line is open.

Even at a high level of any comments on that front would be it would be helpful. And then just given some of the setbacks that have.

I guess besides some of your oral competitors in the UC landscape if thats.

Faheem Hasnain: In terms of the patient population, you know, we designed it to target a population mild to moderate based on the Mayo score and with an endoscopic subscore of two. You know, we'll have to wait till we get the top line results first half of next year to figure out the full demographics, but based on what our enrollment and characteristics have been, we're confident that we've targeted the right population.

Changed any any of your viewpoint as you think about.

That moderate to severe population going forward I recognize the early efforts around mild to moderate but.

The landscape around you has sort of shifted no pun intended.

Yes, certainly as it relates to the landscape.

You see Youre absolutely right. There is definitely some shifting that is occurring and and while we're in a very interesting position in this.

Mild to moderate segment and given the pace of enrollment I think it's a.

A reasonable view to the attractiveness of the profile of this drug.

Clearly we would.

Olivia Breyer: Your next question comes from Olivia Breyer. Your line is open.

Olivia Breyer: Hi guys. Thanks for the questions. I wanted to ask you about your latest expectations for efficacy measures in the TORI study. I know you've talked about wanting to see some more PVR reduction, so tatter sats, and I think that was, you know, the 18 to 32 percent range. And then also on the six-minute walk and that 20 to 30 meter improvement, at least directionally. Is that still the bar you're looking ahead at, or are there any updates to how you're thinking about that readout? And then I've got a follow up on that at UC.

I think the profile of this drug and it just didn't make more attractive quite frankly with the cloud that fits around now safety associated with David.

The JAK class as an example, so I think thats all.

All of that speaks to a bit of a tailwind for this program.

Okay.

In terms of the patient population.

We designed it to target a population of mild to moderate.

Based on Mayo score and with it and discussing sub score of team.

We.

We will have to wait until we get the topline results first half of next year to figure out the full demographics, but.

Based on what.

Speaker: We still believe that those are the right guideposts for what we want to see, and hence, there have been no changes in our thought process.

Our enrollment.

Characteristics have been we're confident that we've targeted the right population.

Thank you.

Okay.

Your next question comes from Olivia Brayer. Your line is now open.

Hi, guys. Thanks for the questions I wanted to ask on your latest expectations for efficacy measures in the Tory study and I know you've talked about wanting to see similar PBR.

Speaker: Okay, got it. And then on to, you know, I know you guys talked a little bit about the landscape earlier, but there are still a number of orals in development. And by the time your asset moves through development, there could be more than one oral modality on the market. So I guess the question is, how do you think about the possible treatment hierarchy for those different oral agents? And, and where do you think Oh, for could be most differentiated there? So, as we know.

So Todd are set and I think I was 18% to 32% range in and then also on six minute walk in that 20 to 30 meter improvement at least directionally. So.

Is that still the bar you're looking ahead or are there any updates on how youre thinking about that readout and then I've got a follow up on that obviously.

We're still.

Believe that those are the right guidepost for what we wanted to see and hence there's been no no changes in our thought process.

Okay got it and then on <unk> four.

I know you guys talked a little bit about the landscape earlier, but there are still a number of oral is in development and there could be more than one.

Oral modality on the market.

By the time you outfit Mr development. So I guess the question is how do you think about the possible treatment hierarchy for those different oral agents and where do you think oh four it could be most differentiated there.

Speaker: So, as we know, unfortunately, none of these treatments are going to be viewed as cures, and like many other autoimmune indications, patients often cycle through treatment. So the availability of a number of treatment choices that have the patient-friendly attribute of being an oral, daily oral, I think is incredibly attractive, and the market is pretty large.

So as we know.

Unfortunately, none of these none of these treatments are can be viewed as cured.

Like many other autoimmune indications patients cycle through through treatment. So.

The availability of a number of treatment choices that have kind of a patient friendly attribute of being an oral daily daily oral I think is incredibly attractive the market is pretty large so.

Speaker: So I think that's kind of the first dimension is that the number of orals on the market is great for patients, but also, there's plenty of room in that context. I think the second dimension here is the positioning that, at least, the first level of positioning in that kind of mild to moderate segment, that post 5-ASA failure, pre-immunosuppressant, pre-biologic, that's a very unique positioning that doesn't have the same kind of.

I think that's kind of the first dimension is that a number of oral <unk> on the market I think is great for patients, but also there is plenty of room in that context, I think the second dimension here is the positioning that we see the first level of positioning and that kind of mild to moderate segment that post five assay failure.

<unk> pre immuno suppressant pre pre biologic, that's a very unique positioning that doesn't doesn't have.

Speaker: Ozanimod, which is a drug we know well, really doesn't play in that space, of course, nor does Jaxx. So I think there's a very unique element of profile for this drug that I think bodes well for the future, assuming that the data works.

The same kind of.

Oral.

Competition is so to speak in other words, the data Mart, which drug we know well really doesn't play in that space of course.

Patrick Ralph Trucchio: Your next question comes from Patrick Trucchio. Your line is open. Hi, thank you for taking my question. And this is Jason speaking for Patrick. And so I guess I just have a two-part question about.

Nor did the jacks. So I think there is a very unique element of profile for this drug that I think bodes.

Well for the future assuming that the data plays out.

Yes.

Great. Thank you guys.

Your next question comes from Patrick.

Jason: Hi, thank you for taking my question. And this is Jason speaking on behalf of Patrick.

Your line is open.

Hi, Thank you for taking my question.

This is Jason speaking for Patrick and so I guess I just have a two part question about the GB PTK inhibitors. So.

So the first question is what is your expected pace of enrolment for your GBP 501 to one and possibly if you can give us some insight on your future study for GBP 7208.

And then the second question is what is your primary end point for your first in human study for your GPU 15121, and thank you.

Speaker: Yeah, so as mentioned, we're currently conducting a normal healthy volunteer study. Our primary point is typically safety tolerability. We'll obviously look at pharmacokinetics, and the nice thing about BTK inhibitors, there's a lot of science behind target engagement biomarkers and receptor occupancy, so we'll also assess those.

Yes so.

As mentioned we are currently conducting a normal healthy volunteer study.

Our primary endpoint is typically for normal healthy volunteers and safety Tolerability, we'll obviously look at.

Pharmacokinetics.

And.

The nice thing about PTK inhibitors, there is a lot of.

Science behind target engagement biomarker, so and receptor occupancy. So we'll we'll also assess those.

Speaker: Your question, furthermore, was around based on. Yeah, it's, you know, it's normal healthy volunteers. So typically, they're done in phase one units where patients are identified, and screened, and put in a queue. So we anticipate that it would go, you know, relatively quickly. Thank you, and then I think you had a question about the 7208. We anticipate also doing a first in human normal healthy volunteers; given that it's a BTK, we'll likely have a similar trial design as

Your question Furthermore was around.

This column.

Yeah.

It's a normal healthy volunteer so typically they're done.

Phase one units where patients are identified.

And screamed and putting Q, so we anticipate that.

It would go.

Relatively.

Quickly.

Alright, thank you.

And then I think you had a question.

I think you had a question about the <unk>.

72, Oh wait.

It's.

We anticipate also doing a first in human normal healthy volunteer given that it's a BT K will likely have a similar trial design as our current normal healthy volunteer was $51 29.

Bryan Giraudo: Your next question comes from Bryan Chang. Your line is open. Hey guys.

Alright, Thank you very much.

Your next your next question comes from Brian Chen Your line is open.

Bryan Giraudo: Hey guys, thanks for taking my question. So maybe the first one on GBE5121, I'm just curious if you have any early thoughts on the inclusion or exclusion criteria for PCNSL using learnings from other BTK inhibitors for this indication, and are you going to be including, are you planning to include patients with, you know, intraocular or CSF involvement? And then I have one quick follow-up. So yes, we are gonna include patients with intraocular and CSF involvement.

Hey, guys. Thanks for taking my question. So maybe first one on TV since Jan 21, I'm. Just curious if you have any early thoughts on.

The inclusion or exclusion criteria for PC NFL.

Some other PTK inhibitor.

Indication.

And are you going to be including are you.

Planning to include patients.

Intra ocular CSF and bachman.

One quick follow up.

So.

Yes.

We are going to include patients with intraocular and CSF.

<unk>, obviously, we're going to enroll patients.

That have refractory.

Or recurrent primary and secondary CNS lymphoma as our initial.

The patient population in our dose escalation once we define a.

<unk> phase II dose, we will then focus on RFP CNS Ah patient population.

As part of our <unk>.

<unk> steady and then as part of a dose expansion.

Conant.

Okay, and maybe on back on sorry, I learned that I'm, just wondering if we would be getting additional OLED updates for the.

Speaker: And maybe back on Sarah Lunib, I'm just wondering if we would be getting additional OLE updates for the compound from the Phase 1b study near term, given that we saw the two patients update last quarter. And I'm just, and also I'm curious if you have any, if you have started looking into any signs of vascular remodeling or hemodynamics in those two patients. Thanks.

The compound from the phase <unk> study in near term given that we saw that two patients update.

Last quarter.

And I'm, just and also I'm curious if you have any EPS, sorry, looking into any signs of vascular remodeling, alright, hemodynamics and dose two patients. Thanks.

Yes, so as you recall, we had two patients complete.

The open label extension of the Phase one b.

One of those patients still continues.

Open label experience as.

We have another protocol that this patient rolled over and they continue to do well.

The other patient decided to go onto another trial and.

And therefore did not go forward in the open label extension of Sarah Loopnet in terms of vascular remodeling, we did not.

Specifically.

Have any assessments of that it's difficult. So the only thing we do have as for example, indirect measures such as <unk> and obviously six minute walk that we're continuing to follow.

Operator: I am showing no further questions at this time. Please continue.

Okay. Thank you.

I am showing no further questions at this time please continue.

Speaker: All right. If there are no further questions, we thank everybody for spending time with us today. And again, my thanks to the team and thanks to all the patients that have enrolled in the trials. We look forward to next quarter being able to continue to give you updates on progress. Thanks, everybody.

Alright, there are no further questions.

Thanks, everybody for spending time with us today and again my thanks to the team and thanks to all the patients that.

That is enrolled in the trial, we look forward to next quarter.

Being able to continue to give you updates on progress.

Hi, everybody.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.

This concludes today's conference call. Thank you for participating you may now disconnect.

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