Q2 2021 Gossamer Bio Inc Earnings Call
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And I would now like the turn the call over to you for your Speaker, Ryan Gerardo Chief Financial Officer, you may begin of countries.
Thank you operator, and thank you all for joining us.
I'm joined on today's call by the Gossamer Bio Chairman and co founder and Chief Executive Officer Anthony.
Richard Aranda, Gossamer Bio's, Chief Medical officer, as well of La Carte Gossamer Bio's, Chief Scientific officer.
Earlier this afternoon, Gossamer Bio Inc press release.
The interest results from the second quarter ended June 30 of 2021.
This decline without the.
Please note that certain information discussed on the call day covered under the Safe Harbor provision.
The Securities litigation of format.
The earnings call Gossamer magical day before.
The statements actual results may differ materially from.
And then of those stated or implied in the sport.
And with the uncertainties associated with the company's business. These forward looking statements are qualified by the data.
And in <unk> news releases, and SEC filings, including the and his work on all of them.
Hi.
The conference call all of the bank.
And at the information that meets.
All of whom the listeners on our own to keep our margin, especially that related to the timely initiation and completion of our clinical studies and addition to our ability to release results from our clinical trial and the time and there may be adversely affected by the ongoing global net.
Gossamer bio takes no obligation to revise or update any forward looking statements reflect the events or circumstances. After the date of this conference call.
Now and then I'll turn the call over to <unk>.
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Sure.
Thanks, Brian and good afternoon to everyone who's joining us on today's call. We appreciate you tuning into this earnings and update call to discuss our effort that gossamer and the effort that we've been making the developed new medicines to meet unmet needs across a variety of diseases and.
<unk> 2021 as the year of execution for Gossamer.
Operator: Good day, and thank you for standing by. Welcome to the Gossamer Bio Q2 earnings call.
And our team has worked tirelessly to set the stage for 2022 could be a transformative year for our portfolio.
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. So if you have a question during the session, you will need to press star 1 on your telephone keypad. And if you require any further assistance, just press star zero. And I would now like to try to call over to your first speaker, Brian Gerardo, Chief Financial Officer. You need to begin your conference.
And I'm going to turn the call over to Richard and a minute to give you a more detailed update but to start the highlights are that we're on track to have 2 phase III data readouts for our 2 lead clinical programs, Sarah Loopnet and GB Oh, Oh for in the first half of 2022 of course subject to further.
The developments and the pandemic.
Much of the focus on the call today will be on share of Loopnet, and so I'm going to start with <unk> or for as I view. This is an equally exciting part of gossamer portfolio.
Bryan Giraudo: Thank you, operator, and thank you all for joining us this afternoon. I'm joining on today's call by Gossmer-Biles Chairman, co-founder, and Chief Executive Officer of the team Haggnais, Richard Miranda.
And the shift you see study of G. D O O for is enrolling 195 patients with active ulcerative colitis, despite treatment with 5 of assay and evaluating the induction of clinical remission at 12 weeks as its primary endpoint.
Bryan Giraudo: and Biosk Medical Officer, as well as Laura Carter, Goshen & Biol's Chief Executive Officer, Sine Titigoff. Earlier this afternoon, Documer Bio issued a press release, announcing its financial results for the second quarter ended June 30, 2021, in addition to providing a corporate update. Please note that certain information discussed on the call today is covered under the State Park of Division of the Private Securities Litigation of Format. The listeners are cautioned listeners that during this call, Gossip Management will be making for looking safe, but actual results may differ materially from those stated or implied by these boards of the statements.
Bryan Giraudo: and the statement which the rest of them.
And we believe that GB Oh for has the potential to disrupt the treatment paradigm and UC and Crohn's disease as an oral non immunosuppressive product candidate that's meant to induce mucosal healing and patients with inflammatory bowel disease.
We're looking forward to the results of the shift do you see steady in 2022.
Now moving on to sort of Loopnet and the Tory study is enrolling 80 patients with pulmonary arterial hypertension and evaluating change and PV are at 24 weeks and its primary endpoint.
Share of Loopnet has the potential to be of disease modifying treatment for P. A a patients for whom the only currently approved treatments are vasodilatin and do not affect the underlying disease pathogenesis.
And we're also excited today to give you a glimpse of the open label data generated with Sarah Loopnet as a reminder, Sarah Loopnet is an inhaled PDGF are.
C kit and CSF, 1 of our kinase inhibitor, which is currently enrolling a phase III study and ph patients.
Bryan Giraudo: These forward-looking statements are qualified by the statements contained in gossomers news releases.
Bryan Giraudo: and SEC filings, including the Android
And on the pandemic allowed just 2 patients to complete the open label extension. So while the dataset is limited. These case studies give us greater confidence that we're on track as we look forward to the readout next year from our 80 patient phase II Tory study and.
And without any further ado I'd like to hand, it over to Dr. Richard Aranda, Gossamer Bio's, Chief Medical Officer, who will provide this update on the share of Loopnet program as well as an update on our other lead clinical program GB of for Richard.
Bryan Giraudo: and taxed and funds. The conference call also contains the kind of information that may be accurate for only a limited period of time. Our ability to meet our guidance, especially that related to the timely initiation and completion of our clinical studies, in addition to our ability
Thank you for Hain today, I am very excited to give an update on the share of Loopnet program, including a look at the safety and Tolerability biomarker and clinical activity data, we obtained in our phase 1 the open label extension.
As you know last year.
We conducted a phase 1 b and W. H O group, what the functional class chewed through for CAH patients the.
And the placebo controlled randomized double blind 2 week treatment period was designed to evaluate the safety and Tolerability of inhaled Sir of Loopnet. As this was our first experience with Cerro Lindo and patients with CAH.
Patient started off at a dose.
Of 45 milligrams of <unk> E and we were dose.
Escalated up to 90 milligrams PID at the investigator's discretion.
In addition to safety and Tolerability and we also were interested in evaluating the plasma PK and PD profile of share Loopnet and the assessment of target engagement.
And this phase <unk> study and included an open label extension period in which patients could receive share at loopnet and for up to 6 months.
We enrolled our first subject and the study and the first quarter of 2020. Unfortunately, the first wave of the COVID-19 virus caused site closures and did not allow the initial group of patients on the study to continue onto the open label extension.
As sites began to reopen we had 2 patients who enrolled and were able to complete the 6 month open label extension.
We were very happy to get some initial experience with several of the.
And patients with ph for up to 6 months, which to our knowledge is the first such date of for an inhaled kinase inhibitor.
I'll share some of that data and a few slides, but first.
On the next slide I want to take you through how we arrived at the 45 milligram and 90 milligram doses, we tested in the study.
Several approaches we are used to inform on dose selection and we have been pleased thus far to see that the PK and target engagement data validate our thinking.
Bryan Giraudo: These results from our clinical trial in a time of error may be adversely affected by the ongoing COVID-19 pandemic. Goss and Revio assumes no obligation to revise or update any forward-looking statements, like events or circumstances after the date of this conference. Now we're going to turn the call over to 15, right?
To remind you of several loopnet was selected and formulate and to be and inhaled therapy for PIH that achieves deposition and the deep lung, resulting in greater lungs for plasma exposure and.
Faheem Hasnain: and good afternoon to everyone who's joining us on today's call. We appreciate you tuning into this earnings call, an update call to discuss our efforts at Gossmer and the efforts that we've been making to develop new medicines to meet unmet needs across a variety of diseases. I've branded 2021 as a year of execution for Gossamer, and our team has worked tirelessly to set the stage for 2022 to be a transformative year for our portfolio.
And it's potentially a more favorable safety profile.
With this intention or dose levels were informed by a combination of animal model data allometric and direct scaling and PK results from human studies.
Faheem Hasnain: I'm going to turn the call over to Richard in a minute to give you a more detailed update, but to start, the highlights are that we're on track to have two phase two data readouts for our two lead clinical programs, Sarah Ludinib and GB-004 in the first half of 2022, subject to further developments in the pandemic. Much of the focus on the call today will be on Sarah Luton.
Faheem Hasnain: So I'm going to start with GB-B-O-O-4 as I view this as an equally exciting part of Gossmer's portfolio. Now, the shift UC study of GB-B-O-O-4 is enrolling 195 patients with active ulcerative colitis despite treatment with 5AsA and evaluating the induction of clinical remission at 12 weeks as its primary endpoint. We believe that GB-B-O-4 has the potential to disrupt the treatment paradigm in UC and Crohn's disease as an oral, non-immunosuppressive product candidate that's meant to induce mucosal healing in patients with inflammatory bowel. We're looking forward to the results of the Shift UC study in 2022.
On the left panel studies in rats indicate that the loans to plasma exposure ratio is on average 30 times.
Faheem Hasnain: Now, moving on to serilutinid, the Tory study is enrolling 80 patients with pulmonary arterial hypertension and evaluating change in PVR at 24 weeks at its primary and prologen. Therilutinib has the potential to be a disease-modifying treatment for PAA patients, for whom the only currently approved treatments are vasodilatory and do not affect the underlying disease pathogenesis. And we're also excited today to give you a glimpse of the open-label data generated with Sarah Ludinib.
Faheem Hasnain: As a reminder, serilutinib is an inhaled PDGFR, C-KIT, and CSF-1R kinase inhibitor which is currently enrolling a phase two study in PAH patients. Now, however, the pandemic allowed just two patients to complete the open label extension. So while the data set is limited, these case studies give us greater confidence that we're on track as we look forward to the readout next year from our 80 patient phase two Tory study. Now, without any further ado, I'd like to hand it over to Dr. Richard Aranda, Gosmer Bios' Chief Medical Officer, who will provide this update on the Sarah Lutna program as well as an update on our other lead clinical Richard?
With a half life of that was approximately double and the loans consistent with <unk> and tenant profile as mentioned previously.
In terms of Allometric and direct scaling of approaches we use the efficacy data from animal models of PIH and the Suzhou hypoxia model, where Sarah Loopnet demonstrated and improvement in hemodynamics and and effect on the modeling of dose level of $12.8 milligrams per kilogram of <unk>.
Richard Aranda: Thank you, Fahim. Today, I am very excited to give an update on the Sarah Lutnik program, including a look at the safety and tolerability, biomarker, and clinical activity data we have trained in our Phase 1B Open Label extension. As you know, last year, we conducted a Phase 1B and WHO Group 1 functional class 2 through 4 PAH patients. The placebo-controlled randomized double-blind two-week treatment period was designed to evaluate the safety and tolerability of inhaled serolutinib, as this was our first experience with serolidinib in patients with PAA.
Richard Aranda: Patients started off at a dose of 45 milligrams BID, and we were dose escalated up to 90 milligrams BID at the investigator's discretion. In addition to safety and tolerability, we were also interested in evaluating the plasma PK and PD profile of serenutinib and the assessment of targeting Gage. This phase 1B study included an open-label extension period in which patients could receive Sarah Luton for We enrolled our first subject in the study in the first quarter of 2020.
Estimates of 90 milligram tid dosing humans.
Finally, we utilize the systemic pharmacokinetic data, we generated and our human studies from normal healthy volunteers.
Based on the animal model of exposure scaling predictions and plasma exposures, we wanted to ensure adequate levels of drug would be and the lung over the dosing period. We were pleased to see that both of our doses are projected to provide adequate free low concentrations of service.
Richard Aranda: Unfortunately, the first wave of the COVID-19 virus caused site closures and did not allow the initial group of patients on the study to continue onto the open label extension. However, as sites began to reopen, we had two patients who enrolled and were able to complete the six-month open label extension. We were very happy to get some initial experience with Sarah Ludub and patients with PH for up to six months, which is, to our knowledge, the first such data for an inhaled kinase. I'll share some of that data in a few slides.
Above both the biochemical and cell based IC 50 values for PDGF, our alpha PDGF, our beta and C kit and the cell based IC 50 for CSF 1 of our 4 of 24 hour period.
We will further describe these predictions and the next slide as we discuss our PK and target engagement and results from gauge patients.
1 of the key objectives of the Phase <unk> study was to ensure that there were no major PK differences and ph patients compared to normal healthy volunteers.
Richard Aranda: But first, on the next slide, I want to take you through how we arrived at the 45 milligram and 90 milligram BID doses we tested in the study. Several approaches were used to inform dose selection, and we have been pleased thus far to see that the PK and target engagement data validate our. To remind you, Sarah Lutin was selected and formulated to be an inhale therapy for PAA that achieves deposition in the deep lung, resulting in greater lung to plasma exposure and hence potentially a more favorable safety profile.
Our data indicated that the PK was similar between ph patients and normal healthy volunteers.
This panel shows the total drug PK profile of.
Inhaled, Sir and Loopnet at the 2 doses of $45 and 90 milligrams the P.
<unk> is characterized by a rapid T. Max of 5 to 6 minutes with approximately of 4 hour half life and the systemic circulation.
Because we believe that efficacy will be driven by free Sir of Loopnet concentrations and the lung the.
Richard Aranda: With this intention, our dose levels were informed by a combination of animal model data, allometric and direct scaling, and PK results from human cells. On the left panel, studies in wraps indicate that the lung to plasma exposure ratio is on average 30 times, with a half-life that was approximately doubled in the lung, consistent with Sarah Lutniv's intended profile as mentioned. In terms of the allometric and direct scaling approaches, we used efficacy data from animal models of PAA.
Next panel on the right shows the projected free drug concentrations and the law.
And this slide also shows the observed plasma concentrations from the ph patients.
Both are overlaid starting from the bottom up onto the biochemical IC fifties for PDGF, our alpha PDGF, our beta C kit and CSF 1 or.
Using the 30 times longed to plasma exposures.
Observed and our preclinical studies the.
The concentrations of achieved and the lung with the 45% to 90 milligram doses are projected to be adequate to the inhibit the targeted kinase.
Richard Aranda: The Nesujent hypoxia model where Serralutin demonstrated an improvement in hemodynamics and an effect on remodeling; a dose level of 12.8 milligrams per kilogram approximates a 90 milligram BID dose. Finally, we utilize the systemic pharmacokinetic data we generated in our human studies from NOMA Healthy Volunteers.
More specifically.
As you can see the Orange and Green PK curves again, representing the model lung concentrations of the 90 and 45 milligram doses, respectively remain above the biochemical IC and <unk> for both PDGF are receptors and GE kit over the course of 12 hours and.
Richard Aranda: Based on the animal model exposure, scaling predictions, and plasma exposures, we wanted to ensure adequate levels of drug would be in the lung over the duration of the treatment. We were pleased to see that both our doses are projected to provide adequate free lung concentrations of serolutinid, above both the biochemical and cell-based IC50 values for PDFR Alpha, PDGFR beta, NCKit, and the cell-based IC50 for CSF We will further describe these predictions in the next slide as we discuss our PK and target engagement results from Gage patients.
And CSF, 1 are partially over that time period.
With the IV dosing, we expect this would provide adequate target coverage and the long over 24 hours, which may translate into efficacy and ph.
Of note the observed rapid clearance of <unk> and the plasma is just as important as our extended coverage and the loans. We believe this profile is essential to help avoid the tolerability and safety liabilities scene with orally administered kinase inhibitors.
Such as <unk> and the phase III impress trial and ph.
1 of the key measures of Pharmacodynamic effect, we employed and our phase <unk> study was of flow cytometry base.
Richard Aranda: One of the key objectives of the Phase 1B study was to ensure that there were no major PK differences between pH patients compared to normal healthy volunteers. Our data indicated that the PK was similar between PAH patients and normal healthy volunteers. This panel shows the total drug PK profile of inhaled serolutinib at the two doses of 45 and 90 milligrams. The PK is characterized by a rapid T-max of five to six minutes with approximately a four-hour half-life in the systemic system.
1 of our target engagement assay and the whole blood.
This took advantage of the fact that set of Loopnet targets the <unk>.
<unk>, 1 receptor and it could be used as a measure of dress effect of inhibiting <unk> receptor internalization.
As shown in the bar graph on the left for.
5 minutes following inhalation of Sarah Loopnet, there and is inhibition of the CSF, 1 our internalization, which recovers towards baseline at the 2 hour time point.
We interpret these data is showing.
Richard Aranda: Because we believe that efficacy will be driven by free serilutinib concentrations in the lung, the next panel on the right shows the projected free drug concentrations in the lung. This slide also shows the observed plasma concentrations from the pH patient. Both are overlaid starting from the bottom up onto the biochemical IC50s for PDGFR Alpha, PDFR Beta, C Kit, and CSF1R.
First set of Loopnet is inhibiting the pathway of 1 of its targets, which appears to be consistent with the observed plasma PK curves showing initial exposure of approaching and then going below the IC 50 of CSF 1 are <unk>.
And second it reflects the intended profile of Sarah Loopnet that is rapid clearance from the systemic circulation lowering the chances for the occurrence of systemic adverse events.
Richard Aranda: Using the 30 times lung to plasma exposures we observed in our preclinical studies, concentrations achieved in the lung with the 45 and 90 milligram doses are projected to be adequate to inhibit the targeted kinase. More specifically, As you can see, the orange and green PK curves, again representing the model lung concentrations of the 90 and 45 milligram doses, respectively, remain above the biochemical IC50s for both PDFR receptors and CKID over the course of 12 hours, and CSF1R partially over that time period.
Overall, it is encouraging to us that these PK and PD data support the pharmacologic activity of our dose prediction predictions.
Next we would like to turns of the results from our phase <unk> study and ph patients.
We had 8 subjects, who completed the 2 weeks and with Cerro Loopnet was generally well tolerated the.
Most frequently reported adverse events were mild to moderate cost associated with emulation and mild headache.
And there were no clinically significant change and labs electrocardiograms pulmonary function test of vital science.
New additions to this slide for versions, we have shown in the past our data from the open label extension.
Richard Aranda: With BID dosing, we expect this would provide adequate target coverage in the lung over 24 hours, which may translate into efficacy and pH. Of note, the observed rapid clearance of serolutinib in the plasma is just as important as our extended coverage in the lung. We believe this profile is essential to help avoid the tolerability and safety liabilities seen with orally administered kinase inhibitors, such as a matant in the Phase 3 press trial in PAA.
As a reminder, given COVID-19 related site closures during the first wave of the pandemic. We were limited to 2 patients who enrolled in the fall of 2020 with extended the open label experience.
This small and requires caution when interpreting results from the experience, but we found the data encouraging and wanted to share it with all of them.
As background, both subjects were classified as functional class III and it came into the study on 3 background therapies, including oral prostacyclin.
Richard Aranda: One of the key measures of pharmacodynamic effect we employed in our phase 1B study was a flow cytometry-based CSF-1R, targeting engagement assay in whole lead. This took advantage of the fact that serilutinid targets the CSF1 receptor, and it could be used as a measure of drug effect through inhibiting receptor internalization, as shown in the bar graph on the left, Five minutes following inhalation of serolutinib, there is inhibition of CSF1R and generalization, which recovers towards baseline at the two-hour time, We interpret these data as showing, First, serolutinate is inhibiting the pathway of one of its targets, which appears to be consistent with the observed plasma PK curves showing initial exposure approaching and then going below the IC50 of CSF1R.
We were reassuring to see that share of Loopnet was tolerated when combined with the standard of care therapies and the subjects.
No serious adverse events occurred and no safety concerns were identified during treatment.
On the right side of the slide our biomarker and 6 minute walk data that were collected over the course of the full 6 month experience for these patients.
The graph on the left shows the change and emptied pro BNP, which is of biomarker of right heart strain and it's used and the risk score of calculations of ph patients.
Decreases and NT Pro BMT were observed in both patients.
The graph to the right depicts changes and the 6 minute walk test, which is the potential registration of clinical endpoint.
Both patients and increase their 6 minute walk distance over the course of the study.
Richard Aranda: And second, it reflects the intended profile of serilutinit, that is, rapid clearance from the systemic circulation, lowering the chances of systemic adverse events. Overall, it's encouraging to us that these PK and PD data support the pharmacologic activity of our dose predictions. We would like to turn to the results from our Phase 1B study in PAH. We had eight subjects who completed the two weeks in which Sarah Luther was generally well tolerated. The most frequently reported adverse events were mild to moderate cough associated with inhalation and mild headaches.
As mentioned previously we want to be careful not to over interpret data from just 2 patients, but we are encouraged to see that both patients tolerated 90 milligrams of the idea of moving them over 6 months on top of 3 background therapies and experienced decreases and empty pro BNP.
And increases in 6 minute walk distance, which are 2 important measures we are tracking inventory steady.
The next slide highlights that we have and E poster presentation at the upcoming virtual European respiratory Society meeting on September 5th on.
Further biomarker analysis from the 2 week treatment period, including data gathered on gene expression changes and evidenced of pathway modulation.
Richard Aranda: There were no clinically significant changes in labs, electrocardiograms, pulmonary function tests, or vital signs. New additions to this slide from versions we have shown in the past are data from the open label extension. As a reminder, given COVID-related site closures during the first wave of the pandemic, we were limited to two patients who had weakened in the fall of 2020 with extended open label experience. This small end requires caution when interpreting results from the experience, but we found the data encouraging and wanted to share it with all of you. As a reminder, both subjects were classified as functional class two, and they came into the study on three background therapies, including oral prosthocytocytics.
I will close the sale of Luna of update with a quick overview of the phase II <unk> study design and endpoints.
And our rolling up to 80 subjects randomized 1 to 1 to several of them for.
For <unk>, we will be testing the same doses and this trial as those study and phase 1 b with patients being up titrated to 90 milligrams twice a day the <unk>.
Primary endpoint of the study is change and pulmonary vascular resistance or PBR at week 20 for.
This study is powered for a change and PBR and we're hoping to see and 18% to 30% placebo corrected improvement, which was which would put us in the same ballpark as the mat net phase 2 and phase III trials and addition to the more recent of tighter set phase II results.
Richard Aranda: We were reassured to see that Sarah Luton was tolerated when combined with standard of care therapies in these subjects. No serious adverse events occurred, and no safety concerns were identified during. On the right side of the slide are biomarker and six-minute walk data that were collected over the course of the full six-month experience for these two patients. The graph on the left shows the change in NP Pro BMP, which is a biomarker of right heart strain and is used in the risk score calculations of pH patients. Decreases in NT ProBMP were observed in both patients.
We will also be looking at 6 minute walk test as the key secondary though the study is not powered to show a significant treatment effect on this endpoint.
Just as a reminder, while imatinib and its phase II study and the high dose and the sort of patterns that pulsar phase III study. Both showed 6 minute walk distance improvements of 21% to 22 meters. Neither were statistically significant results. So while we're hoping to see of similar improvement.
Effort based endpoints with a high degree of bearing and slide 6 minute walk distance.
Richard Aranda: The graph to the right depicts changes in the six-minute walk test, which is a potential registration of clinical endpoint. Both patients increased their six-minute walk over the course of the study. As mentioned previously, we want to be careful not to over-interpret data from just two patients. But we are encouraged to see that both patients tolerated 90 milligrams BID of SIRF LEM over six months on top of three background therapists and experienced decreases in NT ProBMP and increases in six-minute walk, which are two important measures we are tracking in the Tory study.
The require larger studies to reach statistical significance. We will also be looking at changes and biomarkers like empty pro BNP.
Before I turn the call back over to <unk> I also wanted to give a quick update on the GBS zero-zero for program or <unk>, 1 alpha stabilizer for the treatment of IBD, including ulcerative colitis.
Enrollment and the shift UC study of GB Joseph for is continuing and we expect to read out top line results for the primary end point of clinical remission at 12 weeks and the first half of 2022 pending developments and the COVID-19 pandemic.
Richard Aranda: The next slide highlights that we have an e-poster presentation at the upcoming virtual European Respirator Society meeting on September 5th on further biomarker analysis from the two-week treatment period, including data gathered on gene expression changes and evidence of pathway modulation. I will close the Saraluna update with a quick overview of the Phase 2 Tori study design and, We are rolling up to 80 subjects randomized one-to-one to Sarah Lupib. We will be testing the same doses in this trial as those studied in Phase 1B with patients being up-pitrated to 90 milligrams twice a day.
After that 12 week period patients, who have not worse and are kept on the assigned therapy for an additional 24 weeks to evaluate maintenance through a total of 36 weeks.
And finally and October at GWG, Silvio, Tennessee of former President of Echo and the pre eminent IBD.
K O L. At Humana University will present, a post talk analysis of our completed phase <unk> study of <unk> zone, 4 and patients with active EC the.
The analysis focus focuses on composite endpoints combining of clinical endoscopic histologic and molecular readouts.
Richard Aranda: The primary endpoint of the study is change in pulmonary vascular resistance, or pvr, at week 24. This study is powered for a change in PVR, and we're hoping to see an 18 to 30% placebo-corrected improvement, which would put us in the same ballpark as the Amatina phase two and phase three trials in addition to the more recent Tatterset phase two results. We will also be looking at six-minute walk tests as a key secondary, though the study is not powered to show a significant treatment effect on this. Just as a reminder, while a magnetive in its phase two study and the high dose in the Sotatarset Pulsar phase two study both showed six-minute walk distance improvements of 21 to 22 meters, neither were statistically significant results.
<unk> zero zero for outperformed placebo across several of composite endpoints, demonstrating the breadth and depth of the improvement some patients experienced on the study while being treated with <unk> for.
Use of composite endpoints may decrease the placebo response, and the enhanced signal detection and we are excited.
The exciting to be pushing the field of IBD research for alongside Dr. Denise.
And our other close advisors.
With that I will turn the call back over to protein, but I'm happy to answer any questions on the survey nib for the GPS zero zero for programs during the question and answer session for him.
Yes.
The thanks, Richard and the before I hand, it over to Brian I, just wanted to address the future of the GB 12, 75 program as was stated and our earnings release Gossamer is and the process of discontinuing clinical activities related to GB $12.75, which is in the oral <unk> 11, the modulator.
Richard Aranda: So while we're hoping to see a similar improvement, effort-based endpoints with a high degree of variance, like the six-minute walk, typically require larger studies to reach statistical significance. We will also be looking at changes in biomarkers like NT Provee.
For the treatment of solid tumors and.
And while we've generated some encouraging biomarker data and still believe that addressing the immunosuppressive cell types and the tumor microenvironment holds promise for patients the.
Richard Aranda: Before I turn the call back over to Fahim, I also wanted to give a quick update on the GB004 program, our HIF-1 Alpha Stabilizer for the treatment of IBD, including ulcerty coliase, Enrollment in the shift UC study of GB004 is continuing, and we expect to read out top-line results for the primary endpoint of clinical remission at 12 weeks in the first half of 2022 pending developments in the COVID-19 pandemic. After that 12-week period, patients who have not worsened are kept on their assigned therapy for an additional, 24 weeks to evaluate maintenance through a total of 30 And finally, in October at UEGW, Silvio Thunisi, a former president of ECHO in a preeminent IBD, KOL at Humanitas University will present a post hoc analysis of our completed phase 1B study of GB04 in patients with active use, The analysis focuses on composite endpoints, combining clinical, endoscopic, histologic, and molecular readouts.
Richard Aranda: GB004 outperformed placebo across several composite endpoints, demonstrating the breadth and depth of improvement some patients experienced in the study while being treated with GB004. Use of composite endpoints may decrease placebo response and enhance signal detection, and we are excited to be pushing the field of IBD research forward alongside Dr. Denise and our other close advisors. With that, I will turn the call back over to Pahim, but I'm happy to answer any questions on the Sarah Lutnip or the GB004 programs during the question and answer session. Thanks, Richard.
The next step and clinical development would require a sizable phase III program, which is not an investment gossamer will make given our excitement for the phase III there of Loopnet and GB for programs. In addition to the programs and our preclinical pipeline.
And we want to thank all of the patients investigators and caregivers who contributed to this program.
The efforts are immensely appreciated by the <unk> team.
And with that I'll hand, it over to Gossamer Bio's, Chief Financial Officer, Brian Gerardo for a financial update Brian.
Thank you for him and we will now review of the financial results for the second quarter of 2020.
Yes.
7 point of optimism.
We ended the quarter with $409 million of cash cash equivalents, we anticipate our cash cash equivalents and marketable securities along with access to our debt facility will provide us the bidding capital resource on the operations and capital expenditures and second half of 2023.
Research and development expenses, and the second quarter of 2021 or approximately $44.3 million.
Compared to R&D expenses for the $8.7 million from the same period of 2000 and G&A.
G&A expenses were $11.3 billion and second quarter as the debt and G&A expenses of $11.7 million and center plus our net loss for the quarter was $59.8 million. According to the 80 cents per share in the same periods of 2000 and volume reported net losses of $6.9 million, which.
Which equated to $1 per share with that I will turn the call back over the Moon Thomas for closing remarks before we open the line for Q&A for him.
Thanks, Brian.
Again, we appreciate everyone listening in today and we look forward to answering any questions. You may have operator. Please go ahead and open the lines of questions.
Faheem Hasnain: Before I hand it over to Brian, I just want to address the future of the GB1275 program. As was stated in our earnings release, Gossmer is in the process of discontinuing clinical activities related to GB-1275, which is an oral CD-11B modulator for the treatment of solid tumors. And while we generated some encouraging biomarker data and still believe that addressing immunosuppressive cell types in the tumor microenvironment holds promise for patients, the next step in clinical development would require a sizable Phase 2 program, which is not an investment Gossamer will make, given our excitement about the Phase 2 Therlutnib and GB-O-O-4 programs, in addition to the programs in our pre-clinical pipeline
And at this time I would like to ask any questions just breadth sorry on on your telephone keypad and withdraw your question just breast accounts.
And the phosphate is a moment of of biotech.
And your Oscar.
Okay.
Yeah.
And your first question will come from the line of Joseph Schwartz. Your line is open.
Hi, everyone. Thanks, very much for the update.
I was wondering if you could characterize the current status and maybe pace of enrollment inventory and shift do you see I appreciate it's very challenging the project when.
These extensive underwriting takings will wrap up beyond your window of first half of 'twenty, 1, but it would be helpful for us to be able to visualize how far you still need to go given the current state of affairs.
Faheem Hasnain: Now, we want to thank all of the patients, investigators, and caregivers who've contributed to this program. Your efforts are immensely appreciated by the Gossamer team. And with that, I'll hand it over to Gossamer Bio's Chief Financial Officer, Brian Gerado, for a financial update.
Yes, Joe we we have kind of made the point of not commenting on specific enrollment data and.
Bryan Giraudo: Thank you, Pahim. We will now review
Bryan Giraudo: We will now review the financial results for the second quarter of 2020.
And I think we'll stick to that view, but instead of continuing to be consistent with our guidance of the of when you can expect top line data, which again just to reiterate could be first half of 2022.
Bryan Giraudo: doesn't want. We ended the quarter with $409.9 million in cash and cash equivalents. We anticipate our cash and cash equivalents and marketable securities, along with access to our debt facility, will provide us sufficient capital resources to fund operations and capital expenditures into the second half of 2020.
No.
And that's obviously got.
Got it Covid caveat for that as most as most companies do but nonetheless, we feel we feel comfortable and confident and continuing point for that guidance.
Bryan Giraudo: Research and development expenses in the second quarter of 2021 were approximately $44.3 million as compared to R&D expenses of $38.7 million in the same period in 2010. GNA expenses were $11.3 million in the second quarter, as compared to GNA expenses of $11.7 million.
Okay great.
And then maybe a question on <unk> zero for them.
A lot of IBD Kols, we speak with.
Lament the payers frequently restrict the use of novel agents they'd like to use for earlier stage patients or the like earlier stage patients that come to them to have had the opportunity to use and so disease activity often becomes smaller to the merit of lot of patients that might not otherwise progress to the same.
Bryan Giraudo: Our net loss of the quarter was $59.8 million, equating to 80 cents per share. For the same period, 2020, the net loss was $6.9 million, which equated to $1 per share.
And the extent, so I'd love to get your thoughts on what will it take for an agent like <unk> zero zero for the break in where are the new agents have had a hard time getting pairs to grant broad access is it is it just pivotal data and earlier stage patients or do you think there'll be some other.
Bryan Giraudo: With that, I will turn the call back over to Cahim to offer some closing remarks before we open the line for Q&A. Thanks, Brian. Again, we appreciate everyone listening in today, and we look forward to answering any questions you may have. Operator, please go ahead and open the line for questions. Okay, sir, and at this time, if you would like to ask any questions.
The important.
Things that have to.
Paul on the place.
Yes, Joe it's a great question and.
Operator: Okay, sir, and at this time, if you would like to ask any questions, just press star 1 on your telephone keypad. To withdraw your question, just press Poundee. We will pause for a moment to compile the Q&A roster, and your first question will come from the line of Joseph Schwartz. Your line is open.
There's a number of dimensions here on this program I mean, the profile of the program I think lends itself really well to what potentially could be exceptional positioning and the treatment and.
And the treatment paradigm for for IBD patients and that is that.
Given that it's got a it's kind of of non immunosuppressive approach, we can actually push off and.
And the delay the utilization potentially of of more immunosuppressive agent and certainly biologics and that I think that in itself.
Joseph Patrick Schwartz: Hi everyone, thanks very much for the update. I was wondering if you could characterize the current status and maybe pace of enrollment in TORI and shift UC. I appreciate it; it's very challenging to project when these extensive undertaking takings will
Has the potential to be a very attractive attribute theres all kinds of as we know.
Knock on the.
Potential concerns with agents around safety and the like.
Faheem Hasnain: The takings will wrap up beyond your window of the first half of 21, but it would be helpful for us to be able to visualize how far you still need to go given the current state of world affairs.
So.
And it remains to be seen exactly how payers will will treat it and of course, we will need to be thinking about a pricing strategy that that fits well with its position and treatment.
Faheem Hasnain: Yeah, Joe, we have kind of made a point of not commenting on specific enrollment data, and I think we'll stick to that view, but instead, continuing to be consistent with our guidance of when you can expect top-line data, which again, just to reiterate, would be first half 2022. So, you know, that's obviously, you've got a COVID caveat to that, as most, as most, as most companies do, but nonetheless, we feel, uh, we feel comfortable and confident in continuing to point to that guy. Okay, great.
But.
Both.
The potential to bring and and introduce a safer agent.
Post 5 and assay failure per.
The biologic Cree immunosuppressive.
I think it's pretty attractive we've had a lot of great feedback from Kols on this profile. There is definitely a market need and this is a pretty unique niche.
In the context of where this.
It has the opportunity the slate and then of course the opportunity assuming that the safety profile continues to play out as we hope it will the potential for it to be of backbone of therapy could take remission rates too to a new level.
Joseph Patrick Schwartz: And then maybe a question on JB004 then. A lot of IBKOLs we speak with lament that payers frequently restrict the use of novel agents they'd like to use for earlier stage patients, or they'd like earlier stage patients that come to them to have had the opportunity to use. And so disease activity often becomes moderate to severe in a lot of patients that might not otherwise progress to the same extent. So, yeah, I'd love to get your thoughts on what it will take for an agent like GB004 to break through where other new agents have had a hard time getting payers to grant access. Is it just pivotal data in earlier stage patients, or do you think there'll be some other important things that have to fall into place? Yeah, Joe, it's a great question.
I think it is a very interesting premise and potential for this agent as well.
So.
Long story short, we've got we've got and agent that.
Has the potential to slot into a really important slot, which I believe we'd be able to convince payers of I think the kols already are seeing the potential promise for this in the context of treatment.
And I think we will have a lot of wiggle room in the context of how we want to think about our pricing strategy down the road to ensure that the uptake some of their perspective.
Okay that makes sense, thanks for taking my questions.
Okay.
And your next question will come from Jeff Chen Your line of something.
Faheem Hasnain: And I think there are a number of dimensions to this program. I mean, the profile of the program, I think, lends itself really well to what potentially could be exceptional positioning in the treatment paradigm for IBD patients. And that is that given that it's got a, it's kind of a non-immunosuppressive approach, we can actually push off and delay the utilization of potentially more immunosuppressive agents and certainly biologics. And I think that in itself has the potential to be a very attractive attribute.
Hi, guys, just some of the apparel and Jeff. Thanks for the question and congrats on the update.
And no Covid was obviously, a big factor and why it only included 2 patients.
But when we think about the open label portion for the Tories study or the.
Anything outside of the pandemic related issue based on.
1 of the things 1 debt that you can do to help increase the conversion rate just for the phase III given the importance of that longer term data, especially from a regulatory for smartphones and then I have 1 follow up question.
Richard you want to take that.
Yeah.
Faheem Hasnain: There are all kinds of potential concerns, as we know, knock on potential concerns with agents around safety and the like. So, you know, it remains to be seen exactly how payers will treat it. Of course, we'll need to be thinking about a pricing strategy that fits well with its position and treatment; the potential to bring in and introduce a safer agent, post-5 ASA failure, pre-biologic, pre-amines suppressive, I think is pretty attractive. We've had a lot of great feedback from KOLs on this profile.
I think that for.
First of all of that there is.
A great deal of interest.
And the Tories studied by both our sites and thought leaders and by patients obviously.
The <unk> study is going to be much longer.
Then the whole experience that we're going to have with our phase 1 b and so we've learned a lot during the pandemic first of all.
We've tried to make our steady user friendly if you will while not sacrificing quality. So we've embedded all of our learnings.
Into our execution of our Torrey study and.
Faheem Hasnain: There's definitely a market need, and this is a pretty unique niche in the context of where this has the opportunity to be marketed. And then, of course, the opportunity to be marketed. And then, of course, the opportunity, you know, assuming that the safety profile continues to play out as we hope it will, the potential for it to be a back from a therapy to take remission rates to a new level, I think is a very interesting premise and potential for this agent as well.
And made sure that patients are aware of that if they are having benefit.
And the short term.
And even those that are on placebo that they should continue and and the open label extension.
Okay.
And then.
No not in rest of the time, the challenge of and emerging pandemic and a 2 week study to convince you to stay on for 6 months, it's a very different conversation.
And the caregivers when youre talking about on the launch.
Faheem Hasnain: So, you know, long story short, we've got an agent that has the potential to slot into a really important slot, which I believe we could convince payers of. I think the KOLs are already seeing the potential promise for this in the context of treatment. And, you know, I think we'll have a lot of wiggle room in the context of how we want to think about our pricing strategies down the road to ensure that there's uptake from a payer perspective.
Okay perfect. Thanks, guys and then for him when you think about your pipeline priorities for kind of next year.
As oncologists still focus and an area that youre willing to invest heavily and I.
I know you haven't disclosed what preclinical assets you might move forward with yet but are there some internal opportunities specifically within oncology of that debt.
What makes sense to take forward on your own.
Yes, yes.
And we do and our preclinical pipeline, we do have a number of agents that debt will be.
Vectored towards indications in oncology and certainly more to come on that as the.
Operator: And your next question will come from Jeff Nietzim, your line. Hi guys, this is Olivia Barrow.
And as we progress those programs through our pipeline, but yes, the oncology continues to be.
Olivia Barrow: Hi, this is Olivia Barrow. I'm for Jeff.
1 of the areas of of <unk>.
Pursuit and and interest for Gossamer.
Olivia Barrow: Thanks for the questions and congrats on the update. I know COVID was obviously a big factor in why it only included two patients, but when we think about the open-label portion of the Tory study, are there any things outside of the pandemic-related issues that you guys saw in phase one that you can do to help increase the conversion rate just for phase two, given the importance of that longer-term data, you know, especially from a regulatory perspective? And then I have one to follow. up question.
Okay, great. Thanks, guys.
And your next question will come from Carter Gould Your line is open.
Yeah, Hi, this is Justin on for Carter, Thanks for taking the questions.
Looking more broadly at IBP.
1 of the recurrent questions and uncertainty over the JAK class and any way changed how youre thinking about zero for the clearly there's just a lot of attractiveness about of non immunosuppressive profile.
And now sort of given the lingering CV issues. There does that just reinforce your previous view or has there been any further evolution on how you think about the hurdle for clinical meaningfulness there.
Richard Aranda: I think that, first of all, there's a great deal of interest in the TORI study by both our sites and thought leaders and by patients. Obviously, the TORI study is going to be much longer than the whole experience that we're going to have with our Phase 1B. And so, you know, we've learned a lot during the pandemic. First of all, we've tried to make our study user-friendly, if you will, while not sacrificing anything.
Yes.
I think without a doubt it actually gives us.
Even greater conviction on GB of.
Because it continues to stress the need for.
For the novel approaches novel agents and ideally non immuno suppressive.
Approaches so to me it really as I was saying earlier, you've kind of put the spotlight on this program.
Richard Aranda: in quality. So we've embedded all of our learnings into our execution of our TORI study and made sure that patients are aware that if they are having benefits in the short term, and even those that are on placebo, that they should continue in the open label extension.
Given the potential and promise and.
And the mechanism of action.
So.
And without a doubt it just continues to increase our our confidence and and.
And pursuit of this program Richard you on anything else.
No I think that's right on.
And.
Richard Aranda: Don't understand the time the challenge of an emerging pandemic and a two-week study to give
Patients are really looking for.
Richard Aranda: two-week study to convince you to stay on for six months. It's a very different conversation with patients and caregivers when you're talking about a large thing like that.
Something of that.
And potentially could be safer than what's out there and.
As for he mentioned earlier.
That could proceed the use of biologics.
Faheem Hasnain: Okay, perfect. Thanks, guys. And then Fahim, when you think about your pipeline priorities for the next year, is oncology still focused on an area that you're willing to invest heavily in? I know you haven't disclosed what preclinical assets you might move forward with yet, but are there some internal opportunities, you know, specifically within oncology, that you think would make sense to take forward on your own? Yes, yes.
Awesome. Thanks, so much for the update.
And your next question will come from batch of <unk>. Your line is open.
Hi, good evening thanks.
Just a follow up on the non program and the OLED data.
The understanding this is data from just the 2 patients regarding the improvements and T program on 6 minute walk distance from baseline I'm wondering if you can frame for us the clinical relevance of those improvements that we're seeing and distributions and how those could if at all read through too and endpoints such as PV or change.
Faheem Hasnain: Yes, yes. We do, in our preclinical pipeline, we do have a number of ages that will be vectored towards indications in oncology, and certainly more to come on that as we progress those programs through our pipeline. But, yeah, oncology continues to be one of the areas of pursuit and interest for Gossip.
Sure Richard you can take that.
Yeah. So first of all I just want to emphasize that we don't want to over interpret the results.
And from 2 patients but.
Operator: And your next question will come from Carter Gold. Your line is open.
Having said that if you look at the directionality of and both patients that you see a reduction and and anti program 6 minute walk.
Justin: Yeah, hi, this is Justin. I'm for taking the question.
Justin: Looking more broadly at IBD, sort of the recurrent question.
We find that encouraging because it's going and the same direction.
Faheem Hasnain: Have the recurrent questions and uncertainty over the Jack class changed how you're thinking about 004? I mean, clearly, there's a lot of attractiveness about a non-amines suppressive profile, but now, sort of given the lingering CV issues there, does that just reinforce your previous view, or has there been any further evolution on how you think about the hurdle for clinical meaningfulness there? Yeah, I think, without a doubt, it actually gives this even greater conviction about GB-B-O-4 because it continues to stress the need for novel approaches, novel agents, and ideally non-amine suppressive approaches.
As we.
And you know the 6 minute walk has has.
Is encumbered by a lot of variability.
But I think we're intrigued by the NT Pro BNP.
The data in particular, because it's a pretty good reduction.
And once again.
The directional for us, but I think if you look at other studies the empty pro BNP levels tend to be flat or even go up.
And.
The literature once again don't want to over interpret but the literature is fairly clear that NT pro BNP is.
Faheem Hasnain: So to me, it really, as I was saying earlier, it kind of puts a spotlight on this program, given its potential and promise and mechanism of action. So, without a doubt, it just continues to increase our confidence in and in the pursuit of this program. Richard, do you want anything else? No, I think that's right on. And, you know, patients are really looking for something that potentially could be safer than what's out there. And as Fahin mentioned earlier, that could precede the use of biologicals.
<unk> with the parameters such as right atrial pressure PBR and heap of dynamic. So once again, we're trying to point out.
It's encouraging.
Yes, and I'm wondering if the 2 patients were more severe than those that would typically be enrolled in the Tory trial.
Even if they were on the 3 treatments of baseline or they've been fed would they be more representative of I guess the.
Typical baseline for patients with baseline characteristics for those being enrolled inventory trial.
No I think they're going to be.
And quite similar to what we would enroll and the inventory trial.
We anticipate for the role of those with at.
At least 3.203 background medications, we do require a PBR.
Richard Aranda: And your next question will come from Patrick Truccio. Your line is: Hi, good evening, thanks.
The requirement of 400 guidance and but the the baseline NT pro BNP levels are just of.
Patrick Ralph Trucchio: Hi, good evening, thanks. Just a follow-up on the Saralutinan program and the OLA data. You know, the understanding this is data from just the two patients regarding the improvements in the NT Pro BMP and six-minute walk distance from baseline. I'm wondering if you can frame for us the clinical relevance of those improvements that were seen in the two patients and how those could, if at all, read through to an endpoint such as PVR change. Sure. Richard, you can take that.
Right on par with what we would expect.
Got it and that's really helpful. Thank you.
And our next question will come from and then you and your line is open.
Hi, Thank you for taking the question just a follow up on the allowing here and again with the caveat that the only 2 patients but curious if there is anything you saw over the longer period in terms of of time of course of the cost.
Richard Aranda: Yeah, so, first of all, I just want to emphasize that we don't want to over-interpret the result from two patients, but having said that, if you look at the directionality in both patients where you see a reduction in the NT-probe-in-6-minute walk, we find that encouraging because it's going in the same direction. You know, as we mentioned, the six-minute walk has, has, is encumbered by a lot of variability.
Yes.
The cough.
Was predominantly seen in the the double the double blind the first 2 weeks of treatment.
And was very mild.
And as indicated by the patient and the investigator when they reported it and it didn't occur necessarily with every single inhalation patients once they got used to inhaling the drug got used to it and it wasn't a progressive at all and no patients.
Richard Aranda: But I think we're intrigued by the NT Pro BMP data in particular because it's a pretty good reduction and once again it's directional for us, but I think if you look at other studies, the NC ProGMP levels tend to be flat or even go up. And, you know, the literature, once again, don't want to overinterpret, but, you know, the literature is fairly clear that NT Pro BMP is associated with parameters such as right atrial pressure, PVR, and hemodynamics. So once again, as we're trying to point out, it's encouraging.
<unk> or had to reduce.
The their inhalation.
Of drug due to the costs.
Great. That's helpful. And then maybe just 1 for Brian how should we think about the.
And the impact on expenses of the winding down the top 75 program here.
And they're very minimal it was.
It vary.
<unk> study that we did and really I think it's the heme average weighted in the beginning it's really of the avoidance of more expensive.
Phase III studies, which is what are they going to allow us to focus on delivering over 2 <unk> for the timeframe, we talked about and if we are successful.
Our robust balance sheet to enable strategic optionality of of both of those programs.
Richard Aranda: Yeah, and I'm wondering if the two patients were more severe than those that would typically be enrolled in the Tory trial, given that they were on the three treatments at baseline, or if, instead, they would be more representative of, I guess, the typical baseline, or patients with those baseline characteristics for those being enrolled in the Tory trial. No, I think they're going to be quite similar to what we would use in the Tory trial.
Great. Thanks again.
And again, if you have any questions just breadth sorry, and 1 on your telephone keypad. Your next question will come from David Wong. Your line is 1 of them.
Hi, This is Tom for David and Thanks for taking the question.
Just to get a sense of which trial will have the topline data for tolerant or shift of UC and the next year and.
Richard Aranda: You know, we anticipate enrolling those with at least three, two, or three background medications. You know, we do require a PBR requirement of 400 dines, but, you know, the base-fine NT ProBMP levels are just right on par with what we would expect.
And do you know if the.
Phase II trial the old too.
Or for I mean, Bose expose like wait outs and positive for the way you plan to advance the simultaneous interface, we just couldn't get.
The strength.
The plan going forward.
Yes at.
At this point, we're not providing guidance in terms of which program of readout first.
Emma Neelan: And our next question will come from Emma Neelan. Your line is open. Hi, thank you for taking the question. Just a follow-up on the OLE here, and again, you know, with the caveat that it's only two patients, but curious if there was anything you saw over the longer six-buzzling period in terms of the time course of the cost.
Well again I'll, just reiterate we continue to stick.
The stick with our guidance of the both programs to read out first half 2022.
We may we may get a little bit more specificity down the road, but at this point.
<unk>.
That's kind of how kind of will be describing things.
Richard Aranda: Yeah, the cost was predominantly seen in the double blind during the first two weeks of treatment. It was very mild, as indicated by the patient and the investigator when they reported it. And it didn't occur necessarily with every single inhalation patients once they got used to inhaling the drug, got used to it. And it wasn't progressive at all. And no patients discontinued or had to reduce their inhalation of the drug due to the cost.
As it relates to the scenario around 2 positive readouts on on the phase Iis.
We will we will be progressing both of those programs for the next stage of development.
And really trying not to Miss a beat and trying to minimize any time gaps between the top line readout of the phase II and and initiation of of our Registrational studies.
Okay got it.
And that concludes our question and answer session I would now like to turn the call over Kentucky and has 9 for closing remarks.
Bryan Giraudo: Great, that's helpful. And then maybe just one question for Brian. How should we think about the impact on expenses of winding down the 1275 program here?
Yes.
Yes. Thank you very much and I appreciate the questions I appreciate all of you spending time with us today.
Bryan Giraudo: And very minimal. It was a very limited study that we did. And really, as we said in the beginning, it's really the avoidance of more expensive phase two studies, which is really going to allow us to focus on delivering OO2 and OO4 in the time frame we talked about, and if we are successful, to have a robust balance sheet to enable strategic optionality for both those programs. Great.
We are excited about our programs and are looking forward to next year's Readouts.
I would just like to thank the gossamer team for incredible efforts continued incredible efforts.
Working through extraordinary times extraordinary circumstances through what has been arguably a challenging year for everybody in the context of the pandemic.
But this is the company that has an incredibly dedicated group of professionals.
Operator: Great. Thanks again. And again, if you have any questions, just press star 1 on your telephone keypad. Your next question will come from David Wong. Your line is open. This is Tom for David.
And that gets the that gets defined every single day as we make our progress on the studies as we make progress on the enrollment and look forward to making a tremendous difference for patients. So thank you everybody. Thank you very much for spending time of the today and thanks for your questions.
Tom: This is Tom for Dave Aid, and thanks for taking the Just to get the sense of which trial will have the top-line data first, Tauri or shift it, and do know if the phase two trial, the OO2, or all four, I mean, both, like, read out in a positive way, do plan to advance those simultaneous interface three? Just get the same plan.
And that concludes our.
Conference call. Thank you for participating and you may now disconnect.
Okay.
Yes.
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And then.
Okay.
Yes.
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Faheem Hasnain: Yeah, at this point, we're not providing that guidance in terms of which program we'll read out first. We'll, you know, again, I'll just reiterate. We continue to stick with our guidance for both programs to read out first half 2022. We may give a little bit more specificity down the road, but at this point, we, That's kind of how we'll be describing things. As it relates to the scenario around two positive readouts on the phase twos, we will be progressing both of those programs to the next stage of development and really trying not to miss a beat and trying to minimize any time gaps between the top line readout of the phase two and the initiation of our registrational studies.
Yes.
Okay.
And then.
Operator: And as that concludes our question and answer session, I would now like to turn a call over to Sahim Has 9 for the closing room.
Faheem Hasnain: Now, thank you very much. I appreciate the questions. I appreciate all of you spending time with us today. We are excited about our programs and looking forward to next year's readouts. I would just like to thank the Gossamer team for incredible efforts, continued incredible efforts, working through extraordinary times, extraordinary circumstances through what has been arguably a challenging year for everybody in the context of the pandemic. But this is a company that has an incredibly dedicated group of professionals, and that gets to see every single day as we make our progress on these studies, as we make progress on the enrollment, and look forward to making a tremendous difference for So thank you, everybody. Thank you very much. for spending time on this today and thanks for your questions.
Operator: And that concludes our conference call. Thank you for participating. What do you mean, now disconnect?
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Operator: and and and and Thank you Thee and and and and You Thank you, and so on the way. Thank you. Thank you. Thee and so on.
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Operator: Thank you. Thank you. Thank you. Thank you, Thee.
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The day and thank you for standing by and welcome to the Gossamer bio keep the earnings call. At this time all participants are in a listen only mode.
And they get speaker's presentation, there will be a question and answer.
So that's the question during the session you will need the press star 1 on your telephone keypad and.
And you require any further assistance please press star zero and.
And I would now like to try the call over to you for your Speaker Ryan's Jurado, Chief Financial Officer, you may begin of countries.
Thank you operator, and thank you all for joining us from debt.
I am joined on today's call Bio Gossamer, Bio's, Chairman and co founder and Chief Executive Officer.
Right.
Richard Aranda, Gossamer Bio's, Chief Medical officer, as well as law and Carter Gossamer Bio's, Chief Scientific officer.
Earlier this afternoon Gossamer bio of issued press releases announcing its for.
And actual results from the second quarter ended June 30 of 2021 and.
Ladies and value.
Please note that certain information discussed on the call today.
Covered under the safe Harbor provision of the pie.
And the Securities litigation and format.
The argument that the earnings.
Earnings call docile imaginable and forward looking statements.
Actual results may differ materially from those stated or implied guidance for the state.
And the risks and uncertainties associated with the company's business. These forward looking statements are on holiday.
And and customers and news releases and SEC filings, including and the engine we're on pause.
The conference on August 9.
The information that may be accurate for all players.
Our ability to meet our volume, especially that related to the timely initiation and completion of our clinical study and addition to our ability to release results from our clinical trial and the time and there may be adversely affected by the ongoing global debt.
And.
The onslaught of biotechs, no obligation to revise or update any forward looking statements for bus and bus.
Or circumstances after the date of this non stop.
Now I'll and I'll turn the call over to the 8.
Thanks, Brian and good afternoon to everyone who's joining us on today's call and we appreciate you tuning into this earnings and update call to discuss our effort that gossamer and the effort that we've been making the develop new medicines to meet unmet needs across a variety of diseases.
And granted 2021 as the year of execution for Gossamer and.
Operator: Good day, and thank you for standing by. Welcome to the Gossamer Bio Q2 earnings call.
And our team has worked tirelessly to set the stage for 2022 could be a transformative year for our portfolio and.
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 keypad. And if you require any further assistance, just press star zero. And I would now like to turn the call over to your first speaker, Brian Gerardo, Chief Financial Officer. We need to begin your conference.
And I'm going to turn the call over to Richard and a minute to give you a more detailed update but to start the highlights are the we're on track to have 2 phase III data readouts for our 2 lead clinical programs share Loopnet and GB Oh, Oh for and the first half of 2022 of course subject to further.
And the pandemic.
Much of the focus on the call today will be on share of Loopnet and so on.
Bryan Giraudo: Thank you, Operator, and thank you all for joining us this afternoon. I'm joined on today's call by Gossner-Viles, Chairman, co-founder, and Chief Executive Officer, as the team has named. Richard Aranda, Gossom of Biobius Chief Medical Officer, as well as Laura Carter, Gossom of Vice Chief Sniton. Earlier this afternoon, Doc Summer Bio issued press releases after its financial results for the second quarter ended June 30, 2021, in addition to providing a corporate update. Please note that certain information discussed on the call today is covered by the State Harbor Division.
I'm going to start with G. D O O for as I view. This is an equally exciting part of I have got some of these portfolio.
And the ship UC study of G. D O O for is enrolling 195 patients with active ulcerative colitis, despite treatment with 5 day essay and evaluating the induction of clinical remission at 12 weeks as its primary endpoint.
And we believe that GB Oh, Oh for has the potential to disrupt the treatment paradigm and UC and Crohn's disease as an oral non immunosuppressive product candidate that's meant to induce mucosal healing and patients with inflammatory bowel disease.
Bryan Giraudo: of the private security litigation of format. The caution listeners that during this call, gospel management will be making forward-looking statements, actual results may differ materially from those stated or implied in the statements.
We're looking forward to the results of the shift do you see steady in 2022.
Bryan Giraudo: and the school of looking statements.
Bryan Giraudo: These forward-looking statements are qualified by the statements contained in Gossamer's news releases and SEC filings, including the annual report on Form 10K and subsequent filings. The conference call also contains highly expensive information that may be
Now moving on to sort of Loopnet and the Tory study is enrolling 80 patients with pulmonary arterial hypertension and evaluating change and PV are at 24 weeks and its primary endpoint.
Bryan Giraudo: For only a limited period of time, our ability to meet our guidance, especially that related to the timely initiation
Share of Loopnet has the potential to be of disease modifying treatment for P. A a patients for whom the only currently approved treatments are vasodilatin and do not affect the underlying disease pathogenesis.
Bryan Giraudo: in addition to our ability to release results from our clinical trial in a time of error, may be adversely affected by the ongoing
And we're also excited today to give you a glimpse of the open label data generated with Sarah Loopnet. As a reminder, several loopnet is an inhaled PDGF are.
C kit and CSF, 1 of our kinase inhibitor, which is currently enrolling a phase III study and ph patients.
Bryan Giraudo: and then Gosser or Bio shall have no obligation to revise or update any forward-looking statement.
And on the pandemic allowed just 2 patients to complete the open label extension. So while the dataset is limited. These case studies give us greater confidence that we're on track as we look forward to the readout next year from our 80 patient phase 2 Torrey study and.
Bryan Giraudo: update any forward-looking statements like events or circumstances after the date of this conference call. Now we like to turn the call over to Pidine, right?
Faheem Hasnain: Thanks, Brian, and good afternoon to everyone who's joining us on today's call. We appreciate you tuning in to this earnings and update call to discuss our efforts at Gossmer and the efforts that we've been making to develop new medicines to meet unmet needs across a variety of diseases. I've branded 2021 as a year of execution for Gossamer, and our team has worked tirelessly to set the stage for 2022 to be a transformative year for our portfolio.
And without any further ado I'd like to hand, it over to Dr. Richard Aranda, Gossamer Bio's, Chief Medical Officer, who will provide this update on the share of Loopnet program as well as an update on our other lead clinical program G. B O for Richard.
Faheem Hasnain: I'm going to turn the call over to Richard in a minute to give you a more detailed update, but to start, the highlights are that we're on track to have two phase two data readouts for our two lead clinical programs, Sarah Ludinib and GB-004 in the first half of 2022, subject to further developments in the pandemic. Much of the focus on the call today will be on Sarah Luton.
Thank you for him today I am very excited to give an update on the share of Loopnet program, including a look at the safety and Tolerability biomarker and clinical activity data, we obtained in our phase 1 of the open label extension.
As you know last year.
Faheem Hasnain: So I'm going to start with GB-O-O-4 as I view this as an equally exciting part of Gossmer's portfolio. Now, the SHIF UC study of GB-O-O-4 is enrolling 195 patients with active ulcerative colitis despite treatment with 5 ASA and evaluating the induction of clinical remission at 12 weeks as its primary endpoint. We believe that GB004 has the potential to disrupt the treatment paradigm in UC and Crohn's disease as an oral, non-immunosuppressive product candidate that's meant to induce mucosal healing in patients with inflammatory bowel. We're looking forward to the results of the Shift UC study in 2022.
We conducted a phase 1 b and W. H O group, what functional class chewed through for CAH patients.
Placebo controlled randomized double blind 2 week treatment period was designed to evaluate the safety and Tolerability of inhaled share of Loopnet and this was our first experience with Cerro Lindo and patients with CAH.
Patient started off at a dose of.
Of 45 milligrams PID and we were dose.
Escalated up to 90 milligrams PID at the investigator's discretion.
In addition to safety and Tolerability. We also were interested in evaluating the plasma PK and PD profile of share of Loopnet and the assessment of target engagement.
Faheem Hasnain: Now, moving on to serilutinib, the Tory study is enrolling 80 patients with pulmonary arterial hypertension and evaluating change in PVR at 24 weeks as its primary end. Sarah Lutnib has the potential to be a disease-modifying treatment for PAA patients, for whom the only currently approved treatments are vasodilatory and do not affect the underlying disease pathogenesis. And we're also excited today to give you a glimpse of the open-label data generated with Sarah Ludinib.
This phase 1 of these studies included and open label extension period in which patients could receive share Luton and for up to 6 months.
We enrolled our first subject and the study and the first quarter of 2020.
Fortunately the first wave of the COVID-19 virus caused site closures and did not allow the initial group of patients on the study to continue onto the open label extension and.
Sites began to reopen we had 2 patients who enrolled and were able to complete the 6 month open label extension.
We were very happy to get some initial experience with several of them and patients with ph for up to 6 months, which to our knowledge is the first such date of for an inhaled kinase inhibitor.
Faheem Hasnain: As a reminder, serilutinib is an inhaled PDGFR, C-KIT, and CSF-1R kinase inhibitor which is currently enrolling a phase two study in PAHH patients. Now, however, the pandemic allowed just two patients to complete the open label extension. So while the data set is limited, these case studies give us greater confidence that we're on track as we look forward to the readout next year from our 80 patient phase two Tory study. Now, without any further ado, I'd like to hand it over to Dr. Richard Aranda, Gossmer Bios Chief Medical Officer, who will provide this update on the Sarah Lutna program as well as an update on our other lead clinical Richard? Yes, Richard.
I will share some of that data and a few slides, but first.
On the next slide I want to take you through how we arrived at the 45 milligram and 90 milligram doses, we tested and the study.
Several approaches we are used to inform on dose selection and we have been pleased thus far to see that the PK and target engagement data validate our thinking.
To remind you Sarah Loopnet was selected and formulate and to be and inhaled therapy for PIH that achieves deposition and the deep lung, resulting in greater lungs for plasma exposure and.
Richard Aranda: Thank you, Fahim. Today, I am very excited to give an update on the Sarah Lutnit program, including a look at the safety and tolerability, biomarker, and clinical activity data we obtained in our Phase 1B Open Label extension. As you know, last year, we conducted a Phase 1B and WHO Group 1 functional class 2 through 4 PAH patients. The placebo-controlled randomized double-blind two-week treatment period was designed to evaluate the safety and polarability of inhaled serolutinib, as this was our first experience with serolidinib in patients with PAA.
Hence potentially a more favorable safety profile.
With this intention or dose levels were informed by a combination of animal model data allometric and direct scaling and PK results from human studies.
On the left panel studies in rats indicate that the allowance of plasma exposure ratio is on average 30 times.
With a half life of that was approximately double and the loans consistent with the <unk> tender profile as mentioned previously.
In terms of Allometric and direct scaling of approaches we use the efficacy data from animal models of PIH and the Suzhou hypoxia model, where Sarah Loopnet demonstrated and improvement in hemodynamics and in fact on the modeling of dose level of $12.8 milligrams per kilogram of <unk>.
Richard Aranda: Patients started off at a dose of 45 milligrams BID, and we were dose escalated up to 90 milligrams BID at the investigator's discretion. In addition to safety and tolerability, we were also interested in evaluating the plasma PK and PD profile of serabutinib and the assessment of targeting Gage. This phase 1B study included an open-label extension period in which patients could receive Sarah Luton for up to six months. We enrolled our first subject in the study in the first quarter of 2020.
We estimate of 90 milligram tid dosing in humans.
Finally, we utilize the systemic pharmacokinetic data, we generated and our human studies from normal healthy volunteers.
Based on the animal model of exposure scaling predictions and plasma exposures, we wanted to ensure adequate levels of drug would be and the long over the dosing period. We were pleased to see that both of our doses are projected to provide adequate 3 low concentrations of service.
Richard Aranda: Unfortunately, the first wave of the COVID-19 virus caused site closures and did not allow the initial group of patients on the study to continue onto the open label extension. As sites began to reopen, we had two patients who enrolled and were able to complete the six-month open-label extension. We were very happy to get some initial experience with Sarah Ludov and patients with PH for up to six months, which, to our knowledge, is the first such data for an inhaled kinase. I'll share some of that data in a few slides.
Above both the biochemical and cell based IC 50 values for PDGF, our alpha PDGF, our beta and C kit and the cell based IC 50 for CSF 1 of our 4 of 24 hour period.
We will further describe these predictions and the next slide as we discuss our PK and target engagement and results from gauge patients.
1 of the key objectives of the Phase <unk> study was to ensure that there were no major PK differences and ph patients compared to normal healthy volunteers.
Richard Aranda: But first, on the next slide, I want to take you through how we arrived at the 45 milligram and 90 milligram BID doses we tested in the study. Several approaches were used to inform dose selection, and we have been pleased thus far to see that the PK and target engagement data validate our, To remind you, Sarah Lutin was selected and formulated to be an inhale therapy for PAA that achieves deposition in the deep lung, resulting in greater lung to plasma exposure, and hence potentially a more favorable safety profile.
Our data indicated that the PK was similar between ph patients and normal healthy volunteers. This panel shows the total drug PK profile.
Of inhaled, Sarah and Loopnet and the 2 doses of 45 and 90 milligrams the P.
Teekay is characterized by a rapid T. Max of 5 to 6 minutes with approximately a 4 hour half life and the systemic circulation.
Because we believe that efficacy will be driven by 3 <unk> loopnet concentrations and the lung the.
Richard Aranda: With this intention, our dose levels were informed by a combination of animal model data, allometric and direct scaling, and PK results from human studies. In the left panel, studies in rats indicate that the lung to plasma exposure ratio is on average 30 times, with a half-life that was approximately doubled in the lung, consistent with Sarah Lutniv's intended profile as mentioned. In terms of the allometric and direct scaling approaches, we used efficacy data from animal models of PAA.
Next panel on the right shows the projected free drug concentrations and the law.
This slide also shows the observed plasma concentrations from the ph patients.
Both are overlaid starting from the bottom up onto the biochemical IC and <unk> for PDGF, our Alpha PDGF, our beta C kit and CSF 1 or.
Using the 30 times longed to plasma exposures.
Observed and our preclinical studies.
The concentrations of achieved and the lung with the $45 to 90 milligram doses are projected to be adequate to the inhibit the targeted kinase.
Richard Aranda: In the Sujent Hypoxia model, where Serralutin demonstrated an improvement in hemodynamics and an effect on remodeling, a dose level of 12.8 milligrams per kilogram approximates a 90 milligram BID dose. Finally, we utilize the systemic pharmacokinetic data we generated in our human studies from NOMA Healthy Volunteers.
More specifically.
As you can see the Orange and Green PK curves again, representing the model lung concentrations of the 90 and 45 milligram doses, respectively remain above the biochemical IC and <unk> for both PDGF are receptors and G kit over the course of 12 hours and <unk>.
Richard Aranda: Based on the animal model exposure, scaling predictions, and plasma exposures, we wanted to ensure adequate levels of drug would be in the lung over the dosing period. We were pleased to see that both our doses are projected to provide adequate free lung concentrations of serolutin, above both the biochemical and cell-based IC50 values for PDGFR Alpha, PDGFR Beta, NCKit, and the cell-based IC50 for CSF-1 We will further describe these predictions in the next slide as we discuss our PK and target engagement results from Gage patients.
CSF 1 are partially over that time period.
With the IV dosing, we expect this would provide adequate target coverage and the long over 24 hours, which may translate into the efficacy and ph.
Of note the observed rapid clearance of share of Loopnet and the plasma is just as important as our extended coverage and the loans. We believe this profile is essential to help avoid the tolerability and safety liabilities scene with orally administered kinase inhibitors.
Such as Imatinib and the phase III impress trial and PIH.
1 of the key measures of Pharmacodynamic effect, we employed and our phase <unk> study was of flow cytometry base.
Richard Aranda: One of the key objectives of the Phase 1B study was to ensure that there were no major PK differences between pH patients compared to normal healthy volunteers. Our data indicated that the PK was similar between PAH patients and normal healthy volunteers. This panel shows the total drug PK profile of inhaled serolutinib at the two doses of 45 and 90 milliliters. The PK is characterized by a rapid T-max of five to six minutes with approximately a four-hour half-life in the systemic system.
1 of our cars the engagement assay and the whole blood.
This took advantage of the fact that set of Loopnet targets the <unk>.
<unk>, 1 receptor and it could be used as the measure of drug effect of inhibiting <unk> receptor internalization.
As shown in the bar graph on the left for.
5 minutes following inhalation of Sarah Loopnet, the inhibition of CSF, 1 our internalization, which recovers towards baseline at the 2 hour time point.
We interpret these data is showing.
Richard Aranda: Because we believe that efficacy will be driven by free serilutinib concentrations in the lung, the next panel on the right shows the projected free drug concentrations in the lung. This slide also shows the observed plasma concentrations from the pH patient. Both are overlaid starting from the bottom up onto the biochemical IC50s for PDGFR Alpha, PDFR Beta, C Kit, and CSF1R.
The first Sara Loopnet is inhibiting the pathway of 1 of its targets, which appears to be consistent with the observed plasma PK curves showing initial exposure of approaching and then going below the IC 50 of CSF 1 of our <unk>.
And second it reflects the intended profile of Sarah Loopnet that is rapid clearance from the systemic circulation lowering the chances for the occurrence of systemic adverse events.
Overall, it is encouraging to us that these PK and PD data support the pharmacologic activity of our dose prediction predictions.
Richard Aranda: Using the 30 times lung to plasma exposures we observed in our preclinical studies, concentrations achieved in the lung with the 45 and 90 milligram doses are projected to be adequate to inhibit the targeted kinase. More specifically, As you can see, the orange and green PK curves, again representing the model lung concentrations of the 90 and 45 milligram doses, respectively, remain above the biochemical IC50s for both PDFR receptors and CKID over the course of 12 hours, and CSF1R partially over that time period.
Next we would like to turn to the results from our phase <unk> study and ph patients.
We had 8 subjects, who completed the 2 weeks and related share movement was generally well tolerated the.
Most frequently reported adverse events were mild to moderate cost associated with emulation and mild headache.
And there were no clinically significant change and labs electrocardiograms pulmonary function test of vital signs.
New additions to this slide for versions, we have shown in the past our data from the open label extension.
Richard Aranda: With BID dosing, we expect this would provide adequate target coverage in the lung over 24 hours, which may translate into efficacy in pH. Of note, the observed rapid clearance of serolutinib in the plasma is just as important as our extended coverage in the lung. We believe this profile is essential to help avoid the tolerability and safety liabilities seen with orally administered kinase inhibitors, such as a matant in the Phase 3 and Press trial in PAA.
As a reminder, given COVID-19 related site closures during the first wave of the pandemic. We were limited to 2 patients who enrolled in the fall of 2020 with extended the open label experience.
This small and requires caution when interpreting results from the experience, but we found the data encouraging and wanted to share it with all of the.
As background, both subjects were classified as functional class II and it came into the study on 3 background therapies, including oral prostacyclin.
Richard Aranda: One of the key measures of pharmacodynamic effect we employed in our phase 1B study was a flow cytometry-based CSF-1R targeting engagement assay in whole lead. This took advantage of the fact that serilutin targets the CSF1 receptor, and it could be used as a measure of drug effect through inhibiting receptor internalization, as shown in the bar graph on the left. Five minutes following inhalation of serolutnib, there is inhibition of CSF1R and generalization, which recovers towards baseline at the two-hour time.
We were reassured to see that share of Loopnet was tolerated when combined with the standard of care therapies and the subjects.
No serious adverse events occurred and no safety concerns were identified during treatment.
On the right side of the slide our biomarker and 6 minute walk data that were collected over the course of the full 6 month experience for these patients.
The graph on the left shows the change and empty pro BNP, which is of biomarker of right heart strain and its use and the risk score of calculations of ph patients.
Richard Aranda: We interpret these data as showing, First, serolutinate is inhibiting the pathway of one of its targets, which appears to be consistent with the observed plasma PK curves showing initial exposure approaching and then going below the IC50 of CSF1R.
Decreases and NT <unk> were observed in both patients.
The graph to the right depicts changes and the 6 minute walk test, which is the potential registration of clinical endpoint.
Both patients and increase their 6 minute walk distance over the course of the study.
Richard Aranda: And second, it reflects the intended profile of serolutinit, that is, rapid clearance from the systemic circulation, lowering the chances of systemic adverse events. Overall, it's encouraging to us that these PK and PD data support the pharmacologic activity of our dose predictions. We would like to turn to the results from our Phase 1B study in PAH. We had eight subjects who completed the two weeks in which Sarah Routna was generally well tolerated. The most frequently reported adverse events were mild to moderate cough associated with inhalation and mild headaches.
As mentioned previously we want to be careful not to over interpret data from just the patients, but we are encouraged to see that both patients tolerated 90 milligrams of the idea of share net of over 6 months on top of 3 background therapies and experienced decreases and empty pro BNP.
And increases in 6 minute walk distance, which are 2 important measures we are tracking in the Tory study.
The next slide highlights that we have and E poster presentation at the upcoming virtual European respiratory Society meeting on September 5th on.
Further biomarker analysis from the 2 week treatment period, including data gathered on gene expression changes and evidence of pathway modulation.
Richard Aranda: There were no clinically significant changes in labs, electrocardiograms, pulmonary function tests, or vital signs. New additions to this slide from versions we have shown in the past are data from the open label extension. As a reminder, given COVID-related site closures during the first wave of the pandemic, we were limited to two patients who enrolled in the fall of 2020 with extended open-label experience. This small number requires caution when interpreting results from the experience, but we found the data encouraging and wanted to share it with all of you. As background, both subjects were classified as functional class two, and they came into the study on three background therapies, including oral
I will close the Sarah Liv and of update with a quick overview of the phase II <unk> study design and endpoints.
And our rolling up to 80 subjects randomized 1 to 1 to several of them.
For the CFO, we will be testing the same doses and this trial as those study and phase 1 b patients.
Patients being up titrated to 90 milligrams twice a day.
The primary endpoint of the study is change and pulmonary vascular resistance or PBR at week 24 the.
This study is powered for a change and PBR and we're hoping to see and 18% to 30% placebo corrected improvement which was.
Which would put us in the same ballpark as the madness phase II and phase III trials and addition to the more recent of Patterson and phase II results.
Richard Aranda: We were reassured to see that Sarah Luton was tolerated when combined with standard of care therapies in these subjects. No serious adverse events occurred, and no safety concerns were identified during. On the right side of the slide are biomarker and six-minute walk data that were collected over the course of the full six-month experience for these two patients. The graph on the left shows the change in NP Pro BMP, which is a biomarker of right heart strain and is used in the risk score calculations of pH. Decreases in NT ProBMP were observed in both patients.
We will also be looking at 6 minute walk test as the key secondary though the study is not powered to show a significant treatment effect on this endpoint.
Just as a reminder, while the massive and its phase II study and the high dose and the sort of patterns that pulsar phase II study. Both showed 6 minute walk distance improvements of 21% to 22 meters. Neither were statistically significant results. So what we're hoping to see of similar improvement.
Effort based endpoints with a high degree of bearing on slide 6 minute walk distance typically require larger studies to reach statistical significance. We will also be looking at changes and biomarkers like and key pro BNP.
Richard Aranda: The graph to the right depicts changes in the six-minute walk test, which is a potential registrational clinical endpoint. Both patients increased their six-minute walk over the course of the study. As mentioned previously, we want to be careful not to over-interpret data from just two patients, but we are encouraged to see that both patients tolerated 90 milligrams BID of CERCLUM over six months on top of three background therapists and experienced decreases in NT ProVMP and increases in six-minute walk, which are two important measures we are tracking in the Tory study.
Before I turn the call back over to <unk> I also wanted to give a quick update on the <unk> zero for program or <unk>, 1 alpha stabilizer for the treatment of IBD, including ulcerative colitis and.
The enrollment in the shift UC study of GB Joseph for is continuing and we expect to read out topline results for the primary end point of clinical remission at 12 weeks and the first half of 2022 pending developments and the COVID-19 pandemic.
Richard Aranda: The next slide highlights that we have an e-poster presentation at the upcoming virtual European Respiratory Society meeting on September 5th on further biomarker analysis from the two-week treatment period, including data gathered on gene expression changes and evidence of pathway modulation. I will close the Saralounab update with a quick overview of the Phase 2 Tori study design and, We are rolling up to 80 subjects randomized one-to-one to Sarah Lupin. We will be testing the same doses in this trial as in Phase 1B, with patients being up-pitrated to 90 milligrams twice a day.
After that 12 week period patients, who have not worse and are kept on the assigned therapy for an additional 24 weeks to evaluate and maintenance through a total of 36 months.
And finally and October at GWG.
Tennessee of former President of VESCO, and the pre eminent and IBD.
K O L. At Humana Test University will present of post talk analysis of our completed phase <unk> study of GPS of ore zone, 4 and patients with active EC <unk>.
And the analysis focus focuses on composite endpoints, combining and clinical endoscopic histologic and molecular readouts.
Richard Aranda: The primary endpoint of the study is change in pulmonary vascular resistance, or pBR, at week 24. This study is powered for a change in TVR, and we're hoping to see an 18 to 30% placebo-corrected improvement, which would put us in the same ballpark as the Amatina Phase 2 and Phase 3 trials, in addition to the more recent Catter-Set phase 2 results. We will also be looking at six-minute walk tests as a key secondary, though the study is not powered to show a significant treatment effect on this. Just as a reminder, while a magnetive in its phase two study and the high dose in the Sotatarset Pulsar phase two study both showed six-minute walk distance improvements of 21 to 22 meters, neither were statistically significant results.
<unk> zero zero for outperformed placebo across several composite endpoints, demonstrating the breadth and depth of the improvement some patients experience on the study while being treated with <unk> zero zero for.
Use of composite endpoints may decrease placebo response, and the enhanced signal detection and we are excited.
Excited to be pushing the field of IBD research for alongside adopted and EC.
And our other close advisors.
With that I will turn the call back over to protein, but I'm happy to answer any questions on the service for the GBS zero-zero for programs during the question and answer session for him.
<unk>.
Thanks, Richard and the before I hand, it over to Brian I, just wanted to address the future of the GB 12.75 programs.
Richard Aranda: So while we're hoping to see a similar improvement, effort-based endpoints with a high degree of variance, like the six-minute walk, typically require larger studies to reach statistical significance. We will also be looking at changes in biomarkers like NT Prove.
Stated and our earnings release, Gossamer is and the process of discontinuing clinical activities related to GB $12.75, which is an oral CD of 11, <unk> modulator for the treatment of solid tumors and.
And while we've generated some encouraging biomarker data and still believe that addressing the immunosuppressive cell types in the tumor microenvironment holds promise for patients. The next step and clinical development would require a sizable phase III program, which is not an investment gossamer will make given our excitement for the phase III.
Richard Aranda: Before I turn the call back over to Fahim, I also wanted to give a quick update on the GB004 program, our HIF-1 Alpha Stabilizer for the treatment of IBD, including ulcerative colitis. Enrollment in the shift UC study of GB004 is continuing, and we expect to read out top-line results for the primary endpoint of clinical remission at 12 weeks in the first half of 2022, pending developments After that 12-week period, patients who have not worsened are kept on their assigned therapy for an additional 24 weeks to evaluate maintenance through a total of 30.
Richard Aranda: And finally, in October at UEGW, Zubio Dhanisi, a former president of ECHO, in a preeminent IBD conference, KOL at Humanitus University, will present a post hoc analysis of our completed phase 1B study of GB 004 in patients with active use. The analysis focuses on composite endpoints, combining clinical, endoscopic, histologic, and molecular readouts. GB004 outperformed placebo across several composite endpoints, demonstrating the breadth and depth of improvement some patients experienced in the study while being treated with GB004.
Of our Loopnet and GB of for programs. In addition to the programs and our preclinical pipeline.
And we want to thank all of the patients investigators and caregivers who contributed to this program.
The efforts are immensely appreciated by the <unk> team.
And with that I'll hand, it over to Gossamer Bio's, Chief Financial Officer, Brian Gerardo for a financial update Brian.
Thank you for him and we will now review of the financial results for the second quarter of 2020.
7 point of 1 per unit.
The quarter with 400, Bob for $9 million cash cash equivalents weighted.
And our cash cash equivalents and marketable securities along with access to our debt facility will provide a steady and capital resource on the operations and capital expenses and second half of 2023.
Research and development expenses in the second quarter of 2021 for approximately $44.3 million.
Compared to R&D expenses of $38.7 million for the same period of 2020 and G&A.
G&A expenses were $11.3 billion and second quarter as the debt and G&A expenses of $11.7 million and sector 2009 months, our net loss for the quarter was $59.8 million of according to the EPS per share and the same periods of thousands of volume reported a net loss of $6.9 million, which equated to 1.
Richard Aranda: Use of composite endpoints may decrease placebo response and enhanced signal detection, and we are excited to be pushing the field of IBD research forward alongside Dr. Denise and our other close advisors. With that, I will turn the call back over to Pahim, but I'm happy to answer any questions on Sarah Lutnib or the GB004 programs during the question and answer session. Thanks, Richard.
Of our share with that.
I will turn the call back over to the room for some closing remarks before we open the line for Q&A The Inc.
Thanks, Brian again, we appreciate everyone listening in today and we look forward to answering any questions. You may have operator. Please go ahead and open the line for questions.
Faheem Hasnain: Before I hand it over to Brian, I just want to address the future of the GB1275 program. As was stated in our earnings release, Gossmer is in the process of discontinuing clinical activities related to GB-1275, which is an oral CD-11B modulator for the treatment of solid tumors. And while we've generated some encouraging biomarker data and still believe that addressing immunosuppressive cell types in the tumor microenvironment holds promise for patients, the next step in clinical development would require a sizable Phase 2 program, which is not an investment Gossamer will make, given our excitement about the Phase 2 Therolutnib and GB-O-O-4 programs, in addition to the programs in our pre-clinical
Okay and at this time I would like to ask any questions just breadth sorry on on your telephone keypad to withdraw your question just breast accounts you'll parse.
Ross for his demo, Matt the compile the kidney of austerity.
Okay.
And your first question will come from the line of Joseph Schwartz. Your line is open.
Hi, everyone. Thanks, very much for the update.
And I was wondering if you could characterize the current status and maybe pace of enrollment and Tory and the shift do you see I appreciate it's very challenging the project plan.
These extensive underwriting takings will wrap up beyond your window of first half of 'twenty, 1, but it would be helpful for us to be able to visualize how far you still need to go given the current state of the World Affairs.
Faheem Hasnain: Now, we want to thank all of the patients, investigators, and caregivers who've contributed to this program. Your efforts are immensely appreciated by the Gossamer team. And with that, I'll hand it over to Gossamer Bio's chief financial officer, Brian Gerato, for a financial update.
Yes, Joe we.
We have kind of made the point of not commenting on specific enrollment data and.
Bryan Giraudo: Thank you, Pahim. We will now review the
Bryan Giraudo: We will now review the financial results for the second quarter of 2020.
We will stick to that view, but instead of continuing to be consistent with our guidance of the of when you can expect top line data, which again just to reiterate would be first half of 2022.
Bryan Giraudo: 2011. We ended the quarter with $409.9 million cash and cash equivalents.
Bryan Giraudo: We anticipate our cash-cash-cash equivalents and marketable securities, along with access to our debt facility, will provide us sufficient capital resources to fund operations and capital expenditures in the second half of 2020. Research and Development expenses
So.
And that's obviously.
Got it and Covid caveat for that as well.
As most companies do but nonetheless, we feel we feel comfortable and confident and continuing to point for that guidance.
Okay great.
Bryan Giraudo: in the second quarter of 2021 were approximately $44.3 million as compared to R&D expenses of $38.7 million in the same period of 2012.
And then maybe a question on GB zero-zero for them.
A lot of IBD Kols, we speak with.
Lament the payers frequently restrict the use of novel agents they'd like to use for earlier stage patients or the like earlier stage patients that come to them to have had the opportunity to use and so disease activity often becomes moderate team here and a lot of patients that might not otherwise.
Bryan Giraudo: GNA expenses were $11.3 million in the second quarter as compared to the GNA expenses of $11.7 million in the same period of $1,000. Our net loss of the quarter was $59.8 million, according to 80 cents per share. In the same period, 2020, the net loss was $0.9 million, which equated to $1 share.
Breadth to the same extent, so yeah I'd love to get your thoughts on what will it take for an agent like <unk> zero zero forward of break in where are the new agents have had a hard time getting pairs to grant broad access is it is it just pivotal data and earlier stage patients or do you think there'll be some other.
Faheem Hasnain: With that, I will turn the call back over to Cahim to offer some closing remarks before we open the line for Q&A. Thanks, Brian. Again, we appreciate everyone listening in today, and we look forward to answering any questions you may have. Operator, please go ahead and open the line for questions. Okay, sir, and at this time, he would like to ask some questions.
The important.
Things that have to.
Following the place.
Yes, Joe it's a great question and.
Operator: Okay, sir, and at this time, if you would like to ask any questions, just press star 1 on your telephone keypad. To withdraw your question, just press Poundee. We will pause for a moment to compile the Q&A roster, and your first question will come from the line of Joseph Schwartz. Your line is open.
Think there's a number of dimensions here on this program I mean, the profile of the program I think lends itself really well to what potentially could be exceptional positioning and the treatment and.
And the treatment paradigm for for IBD patients and that is that.
Given that it's got a it's kind of of non immunosuppressive approach, we can actually push off and.
And delay the utilization potentially of of more of immunosuppressive agents, and certainly biologics and I think that in itself.
Joseph Patrick Schwartz: Hi everyone, thanks very much for the update. I was wondering if you could characterize the current status and maybe pace of enrollment in TORI and shift UC. I appreciate it. It's very challenging to project when
Has the potential to be a very attractive attribute there's all kinds of as we know and.
Knock on the.
Potential concerns with agents around safety and the like.
Faheem Hasnain: The takings will wrap up beyond your window of the first half of 21, but it would be helpful for us to be able to visualize how far you still need to go given the current state of world affairs.
So.
And it remains to be seen exactly how payers will will treat it and of course, we will need to be thinking about a pricing strategy that that fits well with its position and treatment.
Faheem Hasnain: Yeah, Joe, we have kind of made a point of not commenting on specific enrollment data, and I think we'll stick to that view, but instead, continuing to be consistent with our guidance of when you can expect top-line data, which again, just to reiterate, would be first half 2022. So, you know, that's obviously, you've got a COVID caveat to that, as most, as most, as most companies do, but nonetheless, we feel, uh, we feel comfortable and confident in continuing to point to that guy. Okay, great. And then maybe a question on JB004 then?
But both.
The potential to bring in and introduce a safer agent.
Post 5 of NSA failure per.
The biologic pre immunosuppressive.
I think it's pretty attractive we've had a lot of great feedback from Kols on this profile. There is definitely a market need and this is a pretty unique niche.
In the context of where this has this has the opportunity the slated and then of course the opportunity assuming that the safety profile continues to play out as we hope it will the potential for it to be of backbone of therapy to take remission rates too to a new level.
Joseph Patrick Schwartz: A lot of IBD, KOL,
Faheem Hasnain: I lament that payers frequently restrict the use of novel agents they'd like to use for earlier stage patients, or they'd like earlier stage patients that come to them to have had the opportunity to use them, and so disease activity often becomes moderate to severe in a lot of patients that might not otherwise progress to the same extent, so yeah, I'd love to get your thoughts on what it will take for an agent like gb004 to break in where other Is it just pivotal data in earlier stage patients, or do you think there'll be some other important things that have to fall into place? Yeah, Joe, it's a great question.
I think it is a very interesting premise and potential for this agent as well.
So.
Long story short, we've got we've got and agent that.
Has the potential to slot into a really important slot, which I believe we'd be able to convince payers of I think the kols already are seeing potential promise for this in the context of treatment.
And I.
I think we will have a lot of wiggle room in the context of how we want to think about our pricing strategy down the road to ensure that there is.
Uptake from payer perspective.
Okay that makes sense, thanks for taking my questions.
Okay.
And your next question will come from Jeff Kim Your line is open.
Faheem Hasnain: And I think there are a number of dimensions to this program. I mean, the profile of the program, I think, lends itself really well to what potentially could be exceptional positioning in the treatment paradigm for IBD patients. And that is that given that it's got a, it's kind of a non-immunist depressive approach, we can actually push off and delay the utilization of potentially more immunosuppressive agents and certainly biologics.
Hi, guys, just some of your balance and Jeff. Thanks for the question and congrats on the update.
And I know of Covid was obviously, a big factor and why it only included 2 patients.
When we think about the open label portion for the tour study and.
And these things outside of the pandemic related issue and I saw on the phase 1 debt that you can do to help increase the conversion rate just for the phase III given the importance of that longer term data, especially from a regulatory perspective, and then I have 1 follow up question.
Faheem Hasnain: And I think that in itself has the potential to be a very attractive attribute. There are all kinds of knock-on potential concerns with agents around safety and the like. So, you know, it remains to be seen exactly how payers will treat it. Of course, we'll need to be thinking about a pricing strategy that fits well with its position and treatment. The potential to bring in and introduce a safer agent, post-5 ASA failure, pre-biologic, pre-amina-suppressive, I think is pretty attractive. We've had a lot of great feedback from KOLs on this profile.
Richard you want to take that.
Yeah.
I think that.
First of all of that there is.
A great deal of interest.
And the Tories studied by both our sites and thought leaders and by patients obviously.
The <unk> study is going to be much longer.
And then the whole experience that we're going to have with our phase 1 b and so we've learned a lot.
Lot during the pandemic first of all.
We've tried to make our steady user friendly if you will while not sacrificing quality. So we've embedded on.
All of our learnings and.
2 our execution of our Torrey study and made sure that patients are aware of that if they are having benefit.
Faheem Hasnain: There's definitely a market need, and this is a pretty unique niche in the context of where this has the opportunity to be marketed. And then, of course, the opportunity, you know, assuming that the safety profile continues to play out as we hope it will, the potential for it to be a backbone therapy to take remission rates to a new level, I think is a very interesting premise and potential for this agent as well.
And the short term.
And even those that are on placebo that they should continue and in the open label extension.
Okay and then.
Non interest.
And the time, the challenge of and emerging pandemic and a 2 week study to convince people to stay on for 6 months, it's a very different the arbitration.
And caregivers.
Faheem Hasnain: So, you know, long story short, we've got an agent that has the potential to slot into a really important slot, which I believe we could convince payers of. I think the KOLs are already seeing the potential promise for this in the context of treatment. And, you know, I think we'll have a lot of wiggle room in the context of how we want to think about our pricing strategies down the road to ensure that there's uptake from a payer perspective.
And you talked about all along.
Okay perfect. Thanks, guys and then for him when you think about your pipeline priorities within the next year is on the.
College, and still focus and an area that youre willing to invest heavily and I know you haven't disclosed preclinical assets you might move forward with yet, but but are there some internal opportunities specifically within oncology that that you think would make sense to take forward on your own.
Yes, yes.
We do and our preclinical pipeline, we do have a number of agents that debt will.
And we'll be vectored towards indications.
And oncology and certainly more to come on that as the as we progress those programs through our pipeline, but yes. The oncology continues to be 1.
Operator: And your next question will come from Jeff, Mietim, your line. Hi guys, this is Olivia Barrow. I'm from Jeff.
Olivia Barrow: Hi, this is Olivia Barrow. I'm from Jeff.
1 of the areas of of <unk>.
Olivia Barrow: Thanks for the questions and congrats on the update. I know COVID was obviously a big factor in why it only included two patients. But when we think about the open-label portion of the Tory study, are there anything outside of the pandemic-related issues that you guys saw in phase one that you can do to help increase the conversion rate just for phase two, given the importance of that longer-term data, you know, especially from a regulatory perspective? And then I have one follow-up question.
And interest for Gossamer.
Okay, great. Thanks, guys.
And your next question will come from Carter Gould Your line is open.
Yeah, Hi, this is Justin on for Carter, Thanks for taking the questions.
And looking more broadly at IBP the sort.
Of the recurrent questions on uncertainty over the JAK class and any way changed how youre thinking about the or is there for I mean, clearly there's just a lot of attractiveness of out of non immunosuppressive profile.
And now sort of given the lingering CV issues. There does that just reinforce your previous view or has there been any further evolution on how you think about the hurdle for clinical meaningfulness there.
Richard Aranda: I think that, first of all, there's a great deal of interest in the Tory study by both our sites and thought leaders and by patients. Obviously, the Tory study is going to be much longer than the whole experience that we're going to have with our Phase 1B. And so, you know, we've learned a lot during the pandemic. First of all, we've tried to make our study user-friendly, if you will, while not sacrificing anything.
Yeah.
I think without a doubt it actually gives us.
Even greater conviction on GB or for.
Because it continues to stress the need for for.
For the novel approaches novel agents and ideally non immuno suppressive.
Approaches.
And to me it really as I was saying earlier it kind of put the spotlight on this program.
Richard Aranda: in quality. So we've embedded all of our learnings into our execution of our TORI study and made sure that patients are aware that if they are having benefits in the short term, and even those that are on placebo,
Given the potential and promise and mechanism of action.
So.
Yeah without a doubt it just continues to increase our our confidence and and.
And in pursuit of this program Richard you on anything else.
No I think thats.
Right on.
And.
Richard Aranda: Don't understand the time, the challenge of an emerging pandemic, and a two-week study to convince you that you can stay on for six months. It's a very different conversation with patients and caregivers when you're talking about a long time.
Patients are really looking for.
Something of that.
And potentially could be safer than what's out there and of.
As for he mentioned earlier.
Proceed the use of biologics.
Faheem Hasnain: Okay, perfect. Thanks, guys. And then, Sahim, when you think about your pipeline priorities, looking the next year, is oncology still a focus that you're willing to invest heavily in? I know you haven't disclosed what preclinical assets you might move forward with yet, but are there some internal opportunities, you know, specifically within oncology, that you think would make sense to take forward on your own? Yes, yes.
Awesome. Thanks, so much for the update.
And your next question will come from batch of <unk>. Your line is open.
Hi, good evening thanks.
Just a follow up on the non program and the OLED data.
The understanding this is data from just the 2 patients regarding the improvements and anti <unk> 6 minute walk distance from baseline and I'm wondering if you can frame for us the clinical relevance of those improvements that we're seeing and the 2 patients and how those could if at all read through too and endpoints such as the PV or change.
Faheem Hasnain: Yes, yes. We do, in our preclinical pipeline, we do have a number of agents that will be vectored towards indications in oncology, and certainly more to come on that as we progress those programs through our pipeline. But, yeah, oncology continues to be one of the areas of pursuit and interest for Gastralia.
Sure Richard you can take that.
Yeah. So first of all I just want to emphasize that we don't want to over interpret the results.
From 2 patients but.
Operator: And your next question will come from Carter Gold. Your line is open.
Having said that if you look at the directionality of and both patients that you see a reduction and and anti protein 6 minute walk.
Justin: Yeah, hi, this is Justin, with Carter. Thanks for taking the questions. Looking more broadly at IBD, have the recurrent questions and uncertainty over the Jack class changed how you're thinking about 004? I mean, clearly, there's just a lot of attractiveness about a non-aminesuppressive profile, but now, sort of given the lingering CV issues there, does that just reinforce your previous view, or has there been any further evolution on how you think about the hurdle for clinical meaningfulness there?
We find that encouraging because it is going and the same direction.
As we mentioned you know the 6 minute walk has has.
Is encumbered by a lot of variability.
But I think we're intrigued by the NT Pro BNP.
The data in particular, because it's a pretty good reduction.
Justin: Yeah, I think without a doubt it actually gives this even greater conviction about GB-B-O-4 because it continues to stress the need for novel approaches, novel agents, and ideally non-immunosuppressive approaches. So to me, it really, as I was saying earlier, it kind of puts a spotlight on this program, given its potential and promise and mechanism of action. So, without a doubt, it just continues to increase our confidence in and, uh, in the pursuit of this program.
And once again.
Directional for us, but I think if you look at other studies the empty pro BNP levels tend to be flat or even go up.
And.
The the literature once again don't want to over interpret but the literature is fairly clear that empty pro BNP is.
<unk> with the parameters such as right atrial pressure PBR and hemodynamics, so once again and as we're trying to point out.
It's encouraging.
Yes, and I'm wondering if the 2 patients were more severe than those that would typically be enrolled and nocturia trial.
Justin: Richard, do you want anything else? No, I think that's right on. And, you know, patients are really looking for something that potentially could be safer than what's out there. And as Fahin mentioned earlier, that could lead to the use of biologicals.
And if they were on the 3 treatments of baseline or they've been fed would they be more representative of the typical baseline care of patients with baseline characteristics for those being enrolled inventory trial.
No I think they're going to be.
And quite similar to what we would enroll and the inventory trial.
We anticipate for the role of those with at.
At least 3.203 background medications, we do require a PBR.
Faheem Hasnain: And your next question will come from Patrick Truccio. Hi, good evening, thanks. Just a follow up on this, sir.
The requirement of 400 guidance and but the the baseline NT pro BNP levels are just of.
Operator: Hi, good evening, thanks. Just a follow-up on the CereLutin program and the OLA data. You know, the understanding this is data from just the two patients regarding the improvements in the NT Pro BMP and six-minute walk distance from baseline. I'm wondering if you can frame for us the clinical relevance of those improvements that were seen in the two patients and how those could, if at all, read through to an endpoint such as PVR change. Sure. Richard, you can take that.
Right on par with what we would expect.
Got it and that's really helpful. Thank you.
And our next question will come from and then the land your line is open.
Hi, Thank you for taking the question just a follow up on the allowing here and it got and with the caveat that the only 2 patients but curious if there is anything you saw or the longer 6 months treatment period in terms of of time of course of the cost.
Richard Aranda: Yeah, so, first of all, I just want to emphasize that we don't want to over-interpret the result from a few patients, but having said that, if you look at the directionality in both patients where you see a reduction in antipropion P and the 6-minute walk, we find that encouraging because it's going in the same direction. You know, as we mentioned, the six-minute walk is encumbered by a lot of variability.
Yes.
The cough.
Was predominantly seen and the double the double blind the first 2 weeks of treatment.
And was very mild.
And as indicated by the patient and the investigator when they reported it and it didn't occur necessarily with every single inhalation patients once they got used to inhaling the drug got used to it and it wasn't a progressive at all and no patients.
Richard Aranda: But I think we're intrigued by the NP Pro BMP data in particular because it's a pretty good reduction and, once again, it's directional for us, but I think if you look at other studies, the NC ProG&P levels tend to be flat or even go up. And, you know, the literature, once again, don't want to overinterpret, but the literature is fairly clear that NT ProBMP is associated with parameters such as right atrial pressure, pvr, and hemodynamics. So once again, as we're trying to point out, it's encouraged.
<unk> or had to reduce.
The their inhalation.
Of drug due to the costs.
Great. That's helpful. And then maybe just 1 for Brian how should we think about the.
The impact on expenses of winding down the top 75 program here.
And they're very minimal it was.
It vary.
<unk> study that we did and really I think it's the heme episode and the beginning it's really of the avoidance of more expensive.
Phase III studies, which is really going to allow us to focus on delivering over 2 and a foreign timeframe, we talked about and that we are successful and up.
Our robust balance sheet to enable strategic option out of the both of those programs.
Richard Aranda: Yeah, and I'm wondering if the two patients were more severe than those that would typically be enrolled in the Tory trial, given that they were on the three treatments at baseline, or if, instead, they would be more representative of, I guess, the typical baseline care patients with those baseline characteristics for those being enrolled in the Tory trial. No, I think they're going to be quite similar to what we would use in the Tory trial.
Great. Thanks again.
And again, if he has any questions just breadth sorry, and 1 on your telephone keypad. Your next question will come from David Wong Your line is open.
Hi, This is Tom for David and Thanks for taking the question.
Just to get a sense of week trial will have to top line data first tolerant or shift of UC and the next year and.
Richard Aranda: You know, we anticipate enrolling those with at least three, two, or three background medications. You know, we do require a PBR requirement of 400 dines, but, you know, the base-finance pro bnp levels are just right on par with what we would expect.
And.
And do you know if the phase II trial the old <unk>.
<unk>.
Or for both a proposed like laid out and positive for the way do plan to advance those same opinions in the phase III.
At the same time.
Going forward.
Yeah.
At this point, we're not providing that guidance in terms of which program will read out first.
Emma Neelan: And our next question will come from Emma Neelan. Your line is open. Hi, thank you for taking the question. Just a follow-up on the OLE here, and again, you know, with the caveat that it's only two patients, but curious if there was anything you saw over the longer six-month treatment period in terms of the time course of the cough.
Well again I'll, just reiterate we continue to stick.
And stick with our guidance of the both programs to read out first half 2022.
We may we may get a little bit more specificity down the road, but at this point.
Richard Aranda: Yeah, the cost was predominantly seen in the double blind during the first two weeks of treatment. It was very mild, as indicated by the patient and the investigator when they reported it. And it didn't necessarily occur necessarily with every single inhalation; patients once they got used to inhaling the drug got used to it. And it wasn't progressive at all. And no patients discontinued or had to reduce their inhalation of the drug due to the cost.
<unk>.
That's kind of how we will be describing things.
As it relates to the scenario around 2 positive readouts on on the phase twos.
We will we will be progressing both of those programs to the next stage of development.
And really trying not to Miss a beat and trying to minimize any time gaps between the top line readout of the phase II and and initiation of of our Registrational studies.
Okay got it.
And this does that continue for a question and answer session I would now like to turn the call over to <unk> has 9 for closing remarks.
Bryan Giraudo: Great, that's helpful. And then maybe just one for Brian. How should we think about, you know, the impact on expenses of winding down the 1275 program here?
Yes.
Yes. Thank you very much and I appreciate the questions I appreciate all of you spending time with us today.
Bryan Giraudo: They're very minimal. It was a very limited study that we did, and really, as we said in the beginning, it's really the avoidance of more expensive phase two studies, which is really going to allow us to focus on delivering OO2 and 004 in the time frame we talked about, and if we are successful, to have a robust balance sheet to enable strategic optionality for both those programs.
We are excited about our programs and are looking forward to kind of next year's Readouts.
I would just like to thank the gossamer team for incredible efforts continued incredible efforts.
Working through extraordinary times extraordinary circumstances through what has been arguably a challenging year for everybody in the context of the pandemic.
But this is the company that has an incredibly dedicated group of professionals.
Operator: Great. Thanks again. And again, if you have any questions, just press star 1 on your telephone keypad. Your next question will come from David Wong. Your line is open. Hi, this is Tom on behalf of David, and thanks for taking
And that gets debt that gets defined every single day.
And we make our progress on the studies as we make the progress on the enrollment and look forward to making a tremendous difference for patients. So thank you everybody. Thank you very much for spending time of the today and thanks for your questions.
Tom: This is Tom for Davey, and thanks for taking the Just to get the sense of which trial will have good offline data first, Tauri or shift you, and do know if the phase two trial, the O2, or all four, I mean, if both read out in a positive way, do plan to advance both simultaneous interface three, just get the same plan Yeah, at this point, we're not providing that guidance in terms of which program we'll read We'll, you know, again. I'll just reiterate.
And that concludes our call.
Today's call. Thank you for participating and you may now disconnect.
Tom: We continue to stick with our guidance for both programs to read out first half 2022. We may give a little bit more specificity down the road, but at this point, we, uh, that's kind of how we'll be describing things. As it relates to the scenario around two positive readouts on the phase twos, we will be progressing both of those programs to the next stage of development and really trying not to miss a beat and trying to minimize any time gaps between the top line readout of the phase two and the initiation of our registrational study.
Operator: And as that concludes our question and answer session, I would now like to turn a call over to Sahim has nine for closing.
Faheem Hasnain: Now, thank you very much. I appreciate the questions. I appreciate all of you spending time with us today. We are excited about our programs and looking forward to next year's readouts. I would just like to thank the Gossamer team for incredible efforts, continued incredible efforts, working through extraordinary times, extraordinary circumstances through what has been arguably a challenging year for everybody in the context of the pandemic. But this is a company that has an incredibly dedicated group of professionals, and that gets to see every single day as we make our progress on these studies, as we make progress on the enrollment, and look forward to making a tremendous difference for So thank you, everybody. Thank you very much. for spending time on this today and thanks for your questions.
Operator: And that concludes our conference call. Thank you for participating. You mean out disconnect.