Q3 2019 Earnings Call

Third quarter 2019 earnings call today's call will feature updates from Gossamer Bio's management team followed by a question and answer session I would now I'll turn the call over to Gossamer Bios Chief Financial Officer, Brian to Robert Brian .

Operator: 2019 Earnings Call. Today's call will feature updates from Gossamer Bio's management team, followed by a question and answer session. I will now turn the call over to Gossamer Bio's Chief Financial Officer, Bryan Giraudo. Bryan?

Bryan Giraudo: Thank you, operator, and thank you all for joining us this afternoon. I'm joined on today's call by Gossamer Bio's co-founder and chief executive officer, Dr. Sheila Guzralli, as well as Gossamer's chief medical officer, Dr. Jacob DuPont, and Gossamer's Chief Scientific Officer, Dr. Louisa Salter-Sitt. Earlier this afternoon, Gossamer Bio issued a press release announcing its financial results for the third quarter ended September 30, 2019, and provided a corporate update. Please note that certain information discussed on the call today is covered under the Safe Harbor Provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, Gossamer Management will be making forward-looking statements. However, actual results may differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business.

I'm joined on today's call.

Oh, My gosh, scooped out or Chief Executive Officer, Dr., She lives Robby as well as Gasparas Chief Medical Officer.

Hi, good Dupont.

And customers Chief Scientific Officer, Dr., Luisa salty said.

Earlier this afternoon Gossamer Biod issued a press release announcing its financial results for the third quarter ended September 32019, and provided a corporate update.

Please note that certain information discussed on the call today is covered under the safe Harbor provision.

The private Securities Litigation Reform Act, we caution listeners that during this call Gosper management will be making forward looking statements actual results may differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with the company's business.

Bryan Giraudo: These forward-looking statements are qualified by the statements contained in Gossamer's news releases and SEC filings, including in the annual report on Form 10-K and subsequent filings. This conference call also contains time-sensitive information that may be accurate for only a limited period of time. Gossamer Bio undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference. Now I'd like to call. I'd like to turn the call over to Sheila. Sheila?

These forward looking statements are qualified by the statements containing Gossipers news releases in FCC filings, including in the annual report on Form 10-K , and subsequent filings. This conference call. Also contains time sensitive information that may be accurate for only limited period of time.

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

I would like to call I'd like to turn the call over to Sheila.

Sheila: Thank you, Bryan, and good afternoon to everyone joining us on today's call. Since our initial public offering in February of this year, I have emphasized that Gossamer Bio's goal is to be an industry leader in immunology, inflammation, and oncology and to enhance and extend the lives of patients suffering from such diseases. On today's call, I am excited to further update you on Gossamer's continued progress towards that ambitious goal. I will walk you through the updates and milestones achieved for each of our four clinical stage product candidates, and then Bryan will discuss Gossamer's financial updates, following which I will provide a few closing remarks. We will begin with our most advanced clinical stage product candidate, GP001, an oral DP2 antagonist which we are developing for eosinophilic asthma and other allergic conditions, including chronic rhinocytis, both with and without nasal polyps, and chronic spontaneous urticaria.

Thank you, Brian and good afternoon, everyone joining me.

Since our initial public offering in February of this year I emphasize that gossamer biological it'd be an industry leader in immunology inflammation and oncology.

Yes, and extend the life of patients suffering from especially either.

I today's call I'd say that further update you on gossamer continued progress toward that officials call.

Oh walking into the uptake and also the chief for each of our four clinical stage product candidate and then Brian will discuss golf from a financial update volume, which I will provide you closing remark.

We will begin with our most advanced clinical stage product candidate Gpcrs Irwin, an oral DP two antagonist, which were developing for use in adult ADHD my other allergic condition, including aquatic wayside, both with or without me the pilot and classificatory carrier.

Sheila: Gossamer Bio continues to enroll the lead study for the treatment of moderate to severe e-Sinophilic asthma. LITA is a global phase 2b study testing GB001 over a 24-week treatment period with patients remaining on background therapy. As a reminder, the lead of the study is enrolling a gene of Step 4 and 5 patient population, all of whom must have an e-phenyl count of at least 250 cells per microliter. RETA uses reduction in asthma worsening, a composite measure, at 24 weeks as its primary endpoint. The study is on track to trigger an interim analysis in the first half of 2020, once approximately two-thirds of the patients have completed the trial.

Got my by cutting it doesn't bother me to study for the treatment of modern just sit there isn't a dog outlet.

Yeah, It's a global phase Twob study pressing jeebies user one over 24 with treatment Terry if they hit your meeting on background therapy.

There are lighter elitist study is enrolling DSS four five patient population Oh, no with haven't even if they'll tell that lead to higher but he sells for Michael there.

We don't use reduction no worsening composite measure at 24 weeks as primary endpoint.

The study is on track to trigger an interim analysis in the first half of 2020 was approximately two thirds of the patients have completed the trial.

Sheila: In the second half of 2020, we expect to read out full top-line K2B results for the 400 inpatient trial. In September, at the European Respiratory Society International Congress in Madrid, we presented a poster further detailing GB001's effects in relation to fractional-scale nitric oxide, or phenol, in mild to moderate atopic asthmatics. The data described in the poster suggests that Pheno could serve as a useful prognostic marker for treatment response to GB001, in addition to elevated eosinophils, which is the marker we are currently using to enroll the lead of study. The high pheno subpopulation, who were patients with pheno levels greater than or equal to 35 parts per billion, showed a pheno reduction versus placebo of 13.4 parts per billion

And the second half of 2020, we expect to be out full talk like pay TV. This out for the 400 patient trial.

In September at the European Respiratory Society International Congress in Madrid, we presented a poster further detailing gpcrs are ones that back in relation to fractional scale nitric oxide or feel and mild to moderate a topic athletic.

Hey, Dave described as opposed to suggest that you know could serve as a useful prognostic marker for treatment response to keep it here. There are one in addition to elevate it yes in itself, which is a marker. We are currently using kind of all the lead to study.

The high speed up the population where patients a speed uglier than or equal to 35 parts per billion should it be no reduction versus the see about 13.4 parts per billion.

Sheila: The high pheno subpopulation also showed a mean FEV1 improvement at day 28 versus placebo of 207 mL. In our ongoing Phase II LIDA study, we continue to evaluate pheno as a potential biomarker. Late this past week, at the American College of Allergy, Asthma, and Immunology annual scientific meeting in Houston, we presented two posters related to asthma and GB001. The first contains detailed results from the previously discussed proof-of-concept phase 2 study run by our partner, Cajun Pharma, in 158 mild to moderate Japanese asthmatics. The study met its primary endpoint of change in morning peak expiratory flow from baseline versus placebo.

The high Pheno Subpopulation also showed a mean I think he want improvement I think 28 versus placebo 200 set in the later.

And our ongoing thing to me to study because he says I you know at the potential biomarker.

Maybe just talk to me at the American College of allergy asthma immunology any okay. It is me in Houston, you presented two posters relate to asthma and you get there there are one.

The first contains detailed results for the previously discussed proof of concept phase two study, but by our partner occasion pharma and 158 Mountain lottery Japanese at night.

The study met its primary endpoint achieved and many people X trade flow from baseline versus placebo.

Sheila: Additionally, in this poster, we show that treatment with 20 mg of Gb001 led to a 71% reduction in the risk of asthma worsening in the overall population and an 84% reduction in the elevated eosinophil population. These data reinforce our belief that baseline blood eosinophils are a potential useful marker for response to GB001. As part of our ongoing commercial characterization of the asthma market, the second poster from ACAAI details a real-world analysis of the dynamics and prescription trends for biologic usage in asthma.

Additionally, in the poster we showed that treatment with 20 milligram that he videos are one led to a 71% reduction and the risk of asthma worsening in the overall population at an 84% reduction in the elevated east in adult population.

These theater reinforce our belief that Bayside bloodiest NFL are potentially useful marker for response to give you guys are one.

As part of our ongoing commercial characterization of the asthma market. The second poster from 80, I detailed a real world analysis of the dynamic and prescription trends for biologic usage in asthma.

Oh, Yeah. These posters related gpcrs or one are available on our website, a golf whereby dotcom in the posters and publications section.

Sheila: All three of these posters related to GB001 are available on our website at gossamerbio.com in the posters and publications section. On a previous quarterly call, we announced the first patient dose for our Phase 2 proof-of-concept study of GB001 in chronic rhinocitis, known as the TITAN study. We plan to enroll approximately 100 patients with chronic rhinocytis, both with and without nasal polyps, in the TITAN study, which is designed to measure the effects of GB001 on the Sinonasal Outcome Test, or SNOT22 score, after 16 weeks of treatment in patients who are refractory to intranasal steroids. We remain on track to read out top-line data for this proof-of-con Moving on to our third plant indication for GP001, Chronic Spontaneous Urticaria, or CSU, there is evidence that the Th2 pathway and cell types, such as eosinophils, basophils, and mast cells, are implicated in the pathogenesis of CSU, but the underlying biology does differ from eosinophilic Asthma and CRS.

On a beasley quarterly call, we announced the first patient dose for phase two proof of concept study at GB. There. There are one in chronic waseda known as a pain study.

We plan to enroll approximately 100 patients with chronic line side, both with and without nasal polyps imitate study, which is designed to measure the effect of GBP is there one on the cyto nasal outcome test or not paid before.

After 16 weeks a treatment in patients who are refractory to intranasally sorry.

We remain on track to eat out topline data for this because of concept phase two study and the second half a play funny.

Moving onto our third party indication for Gbpfour, there one hi, My case early care C. S U.

There is evidence that the teams to pathway cell sites, such as you said I feel they themselves and myself are implicated in the pathogenic says yes, yes.

But the underlying biology does differ from eastern itself asthma and CRM.

Sheila: To better understand the effects of this difference in biology, combined with our desire to ensure we are targeting the right patient population, we have decided to initiate a smaller, translational Phase II trial at CSU in the first half of 2020, prior to initiating a larger study. We also continue to evaluate the potential of GB001 for other allergic and inflammatory diseases such as eosinophilic esophagitis. To close on GB001, we are very optimistic about the significant potential that this once-daily oral GP-2 antagonist holds across multiple allergic disease areas with high unmet needs, and we look forward to reporting multiple Phase II top-line readouts in 2020. We will now move on to GB002, our inhaled PDGF receptor inhibitor for the treatment of pulmonary arterial hypertension, also known as PAH. GP-002 has the potential to be the first drug in a new therapeutic class for this destructive and crippling rare disease with high unmet needs and limited classes of approved therapies.

To better understand the effect of is different the biology combine their desire to ensure we are targeting the right patient population, we have decided to initiate a smaller translational phase two trial, yes, you in the first half in 2020 prior to initiating a larger study.

We also continue to evaluate the potential GB news, there one and other allergic and if I'm afraid diseases, such as it's going to feel like it's off a data.

To close on D. videos are one we're very optimistic about the significant potential that this once daily oral he'd be too as having a cold across multiple allergic disease areas, but high unmet need and we look forward to reporting multiple phase two top line yeah in 2020.

We'll now move on to GBP Jojo to our hills PDGF receptor inhibitor the treatment of cold hair care hypertension, often S.P. age.

Even did your two has the potential to be the first drug and new therapeutic classes destructive and crippling rare disease, but high unmet need and limited classes it approved therapy.

Sheila: GV002 has completed Phase 1 safety studies in normal healthy volunteers with no serious adverse events observed and has been granted orphan drug designation from the FDA and the EMA for the treatment of PAH. We've commenced an exploratory translational Phase 1b with a goal of assessing the initial safety and tolerability of GP02 and pH patients and generating target engagement and biomarker data. While we originally expected to begin patient enrollment in the third quarter of 2019, following the receipt of long-term toxicology data, we amended the trial protocol to include a six-month open-label extension following the original two-week study period. We've been working closely with our Phase 1B study sites and investigators to identify appropriate study participants for our Phase 1B study.

You can hear there he was completed phase one safety studies and normal healthy volunteers no serious adverse events observed and it has been granted orphan drug designation from the FDA SDMA for the treatment of P. age.

We've commenced an exploratory transitional phase one be with a goal of especially meaningful safety and tolerability profile, it's easier to ph patients and generate hurried engaged and biomarker data.

Well, we originally expected to begin patient enrollment in a third quarter of 2019. Following the receipt of long term toxicology data we amended the trial protocol to include a six month open label extension following their original two weeks study period.

We've been working closely with our phase Oneb study site and investigators identify appropriate study participants for phase I B study.

Sheila: We expect to begin enrollment in the fourth quarter of 2019, and we expect an initial readout from the Phase 1b trial in the first half of 2020. As a reminder, this coming Sunday and Monday at the American Heart Association Scientific Sessions in Philadelphia, we are excited to present further GW002 preclinical data and two distinct animal models of PEH. The first presentation demonstrates that inhaled delivery of Gb002 is efficacious in preventing pH progression in the RAP monocotylene and pneumonectomy model of pH, and furthermore, Gb002 may be disease-modifying due to its effects on lung remodeling in this rooted model. The second presentation details the results from GPG02 and the FU50416 hypoxia rat model P8. In this model, two weeks of treatment with GB002 significantly reduced right ventricular systolic pressure and mean post-pulmonary arterial pressure. Additionally, decreased plasma levels of NT-proBNP, a biomarker for heart failure, were observed.

That could begin involvement in the fourth quarter 2019, and we expect in this or beat up on the phase on B trial, and the first half of 2000 funny.

As a reminder, this coming Sunday and Monday at the American Heart Association scientific sessions in Philadelphia, We are excited to present further de villiers or acute preclinical data and two distinct animal models. The P. H.

The first presentation demonstrate that he'll delivery of TV series are too is efficacious and per day ph progression in their rathmann accordingly.

Accordingly, and human acting the model N P H and Furthermore, they keep you guys are too maybe disease modifying the wouldn't affect among the modeling and this wouldn't model.

The second piece I detailed results from human desserts, you and the S. U 504, Wednesday hypoxia rat model age and this modeled to lease the treatment would you be near there to significantly reduce right meticulous adopt pressure a meaningful how many archer pressure.

Actually decreased plasma level of an empty pro BNP, a biomarker for heart failure were observed.

Sheila: I view the data presented in these presentations as very promising for the future of the GP00 program at PAH, and if you are at the AHA sessions in Philadelphia, we welcome you to stop by. The abstracts for both presentations are currently on our website, and both posters will become available on our website after the presentation. Additionally, based upon consultation with regulatory authorities and KOLs, we are in the final stages of designing our GB002 Phase 2 study. While the Phase 2 study may not support registration, we believe that the data generated from this study will be incredibly valuable for future registrational studies by assessing PBR, cardiac function measured by echocardiography, and 6-minute walk tests. We plan to initiate the Phase 2 study in the first half of the year.

We view the data presented and these presentations and very promising for the future of the GE because you're preparing P. H and if you are our at that age, especially the Philadelphia, We welcome you to stop by.

The objects are both presentations are currently on our website and both culture that will become available on our website after the presentation.

Additionally, based upon come compensation with regulatory authorities at Caylloma. We're in the final stages of designing or do you need there. There are two phase two study.

Well the phase two study may not support registration, we believe that the data generated from this study will be incredibly valuable for future Registrational study by assessing PDR cardiac function as measured by Echo a six minute walk that.

We plan to initiate a phase two study in the first half of next year.

Next we will discuss Jeebies. Your therefore, an oral kick went out the stabilizer for the treatment of inflammatory bowel disease, including ulcerative colitis or U see.

Sheila: Next, we will discuss GB004, an oral HIF-1 alpha stabilizer for the treatment of inflammatory bowel disease, including ulcerative colitis or UC. GP-004 is a gut-targeted protohydroxide inhibitor designed to preferentially stabilize HIF-1 alpha, a transcription factor involved in the body's protective response at low oxygen levels. We are very excited to see that in October, it was announced that his biology was the subject of the work underlying the 2019 Nobel Prize in Medicine and Physiology.

He has therefore in the Gulf targeted poll make up at inhibitor designed the preferentially stay blankets, one alpha transition factor involved in the body's protective responsible oxygen levels.

We're very excited to see that in October it was a now that hit biology with subject to the work underlying the 2019 Noble prize in medicine at the geology.

Sheila: GP-004 is currently in a Phase 1b trial designed to demonstrate proof of mechanism in UC patients. We are enrolling patients with active mild-to-moderate UC in this four-week study, which is testing one dose of UV-004 versus placebo. Patients enrolling in the trial must have active UC as confirmed by MEA-4 assessment and evidence of colonic inflammation as confirmed by endoscopy. The primary outcome is safety and tolerability, and we plan to evaluate PKPD and hope to see evidence of target engagement, changes in gene expression, and epithelial barrier restoration. We are also collecting information on clinical effects in the study, including Mayo score, and after the treatment period, patients will undergo either flexible sigmoidoscopy or colonoscopy.

Easier. Therefore is currently in a phase RMB designed to demonstrate because the mechanism and easy patients.

We are enrolling patients and after a mountain water you see and this four weeks study, which is testing one goes that you can hear therefore persistency, though.

Patients enrolling in the trial, but that I could you see as confirmed by May of course assessment and evidence of chronic inflammation as confirmed by endoscopy.

The primary I've heard that PK, tolerability, and we plan to evaluate PK PD and hope to see evidence of target engagement, She's a gene expression and epithelial barrier restoration.

There are also some information on clinical effect in the study, including Mayo score and after treatment period pieces will undergo either flexible same way off at the or coal now.

Sheila: We are pleased to say that we are on track to report initial top-line results from the Phase 1b in the first half of 2020. Finally, we will touch on our newest clinical asset, GP-1275, which is an oral CD11B modulator being developed as an immuno-oncology product candidate. TB 1275 is focused on addressing the immunosuppressive myeloid cell population present within tumor tissue. These tumor types include pancreatic, colorectal, prostate, and other significant tumor indications, and GP1275 has received an orphan drug designation from the FDA for the treatment of pancreatic cancer. This morning, we announced that we entered into a clinical trial collaboration and supply agreement with Merck, in which they have agreed to supply their anti-PD-1 antibody, Keytruda, or Pembrolizumab, for our ongoing Phase I-II study of GB1275 in selected solid tumors.

We are pleased to say that we are on track Airport and you just have one of the goes from the seeds on beat in the first half of 2000 funny.

Finally, we will touch on are you kind of glass that you can tell 75, which is an oral 11 demodulator being developed as an immuno oncology product candidate.

He taught them any thought I spoke of divesting the immunosuppressive myeloid cell population president with a tumor tissue.

Or takes a good pancreatic colorectal prostate and other significant to medication.

Give me to all 75 has received orphan drug designation from the FDA for the treatment of pancreatic cancer.

This morning, we announced that we entered into a clinical trial collaboration supply agreement with Merck and which they have agreed to apply their anti PD, one antibody keytruda or pembrolizumab for ongoing phase one two study TV 12, 75, but it's all a tumor.

Sheila: The study, now known as T-Note 836, is actively enrolling patients with pancreatic, gastric, colorectal, esophageal, and triple negative breast cancer. The phase 1 portion of the study consists of dose escalation of GP-1275 monotherapy. And after clearing several monotherapy dose levels, we will initiate dose escalation combinations with mutreta or chemotherapy. We are very excited to collaborate with Merck, an established leader in cancer immunotherapy, as we work to improve the lives of cancer patients. Our team presented a poster detailing the study design at last week's Society for Immunotherapy at Cancer meeting, which can now also be found on our website. We expect to disclose initial data from the study in the second half of 2020, and we will provide updates as the study progresses. Gossamer Bio retains worldwide rights at GP 1270. With that, I will hand it over to Gossamer Bio's Chief Financial Officer, Bryan Giraudo, for a financial update.

The study now known as keynote 836 is actively enrolling patients in pancreatic gastric colorectal it's off a jewel in triple negative breast cancer.

Based on Unfortunately said he consistent dose escalation of GBP 12, 75, monotherapy and after clearing several monotherapy dose level, we will initiate dose escalation combinations of keytruda or chemotherapy.

There are very excited to collaborate with Merck established leader in cancer immunotherapy, I think work to improve the life of cancer patients.

Our team presented a poster detailing the study design and last week's society for immunotherapy of cancer meeting, which can also be done or web site.

Back to disclose initial data from this study a second half of 2020, and we will provide updates at this study progressive.

Got her bio mccain's worldwide right that you'd be fell 75.

With that I will head over to Gotham revised Chief Financial Officer, Brian Gerardo for our financial update Ryan. Thank you Sheila We will now review the financial results for the second quarter 2019.

Bryan Giraudo: Thank you, Sheila. We will now review the financial results for the second quarter of 2012. We ended the quarter with $446 million of cash and cash equivalents. We continue to anticipate that our cash and cash equivalents, plus the capital available to us under our debt facility, will provide us sufficient capital resources into the fourth quarter of 2021. Research and development expenses in the quarter were approximately $40.1 million, which reflects a continued ramp-up of expenses for GB001, 002, 004, and 1275. G&A expenses were $9.8 million in the quarter, with $3 million of that in total stock-based compensation. Our net loss for the quarter is $48.5 million, equated to $0.80 per share. With that, I'll turn it back over to Sheila to offer some closing comments before we open the line for Q&A.

Third quarter.

We ended the quarter with 446 million cash cash equivalents, we continue to anticipate our cash cash equivalents Austin capital available to us under our debt facility will provide a sufficient capital resources into fourth quarter 2021.

Research and development sizes in the quarter were approximately 40.1 million, which reflects the continued ramp up of expenses for gpcrs or one there is early two 004 and 12 75.

Gene expression were $9.8 million in the quarter was $3 million about.

Total stock based compensation.

Our net loss recorders 48.5 million square did any sense for sure.

I'll turn back over to she will talk for some closing comments before we open the lines United Sheila.

Thank you Brian .

Let me draw the call to close we had gone whereby I would like to say all their employee shareholder clinical trial participants and investigators who have invested their time and resources for the better medication.

Sheila: Thank you, Bryan. As we draw this call to a close, we at Gossamer Bio would like to thank all of our employees, shareholders, clinical trial participants, and investigators who have invested their time and resources for the betterment of patients. While we continually strive to advance our product candidates through the clinic, we know that our successes in the areas of immunology, inflammation, and oncology are not possible without your faith and commitment to our shared journey. Thank you for taking the time to join us today, and thank you for your continued interest and support. With that, I will now turn the call over to the operator to begin the question and answer session. Operator

Well the continually strive to advance our potty candidates through the clinic, we know that our successes in the area that immunology information and oncology or not possible without your feet commitment and our share journey.

Thank you for taking the time to join US today. Thank you for your continued interest and support.

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

Ladies and gentlemen, if you all the question or comment at this time. Please press Star then one on your telephone cheaper.

Your question has been asked what are your worst removed yourself into kinship repressed apparel.

Operator: Ladies and gentlemen, if you have a question or comment at this time, please press star then 1 on your telephone keypad. If your question has been answered or you wish to remove yourself from the line, simply press the pound key. Again, if you have a question or comment at this time, please press star then 1 on your telephone keypad. Please stand by while we compile the Q&A list. We have a question or comment from the line of Joseph Schwartz from SVB Lyrinc.

Again or do you have a question or comment at this time. Please press Star then one on your telephone keypad.

Please standby, what we've compiled maturity roster.

[noise] [noise] couple of question or comment from the line or Joseph Schwartz from Sri be Leerink. Your line is open.

Great. Thanks very much.

My only comment is congrats on the progress.

Joseph Patrick Schwartz: Your line is open. Great, thanks very much. My only comment is congratulations on the progress. And then for my first question, on GB001, what is the baseline rate of asthma worsening that you expect to see in the patients you've enrolled in the LITA study? What degree of improvement do you hope to show in this trial? And what kinds of events do you think GB001 has the best opportunity to reduce the rate of, based on your understanding of the biology as well as the endpoint?

And then for my first question I was wondering on Gpcrs or one what is the baseline raised ASML worsening that you expect to see in the patients you've been rolled in the lead a study what degree of improvement do you hope to show in this trial and what kinds of events do.

I think gpcrs marijuana as the best opportunity to reduce the rate of based on your understanding of the biology as well as the endpoint.

Sheila: Great. Thank you, Joseph.

Great. Thank you did the so just to remind everyone. We are looking to enroll a secret disease population interested disease severity. So in that respect the patients were going after I typically a we'll have it a average of two exacerbation a in the p. sitting here.

Sheila: So just to remind everyone, we are looking to enroll a sick or disease population in terms of disease severity. So in that respect, the patients we're going after typically will have an average of two exacerbations in the preceding year prior to the start of enrolling the study at base level. So in terms of what we would like to see for an improvement in that area, again, we're looking at asthma worsening, which is a broader composite endpoint than just the asthma exacerbation rate. So we'll be looking at a number of events, but we are hoping to see a reduction in the range of 30 to 50%. This is similar to what we saw in the Cajun trial, where we saw about a 50% reduction in the proportion of patients who had asthma worsening.

Prior to the start of but im going to study at baseline.

So in terms of what we would like to see it from an improvement in that area again, we're looking at ASMO worsening, which is a broader composite endpoint then just the asthma exacerbation rate. So we'll be looking at a number of event, but we are I'm, hoping to see a reduction in the a range of 30% to 50% reduction is itself.

Were to what we saw in that he can trial, where we saw about a 50% reduction and the proportion of patients who had asthma worsening right. So that's really what we guide patients what we guide I.

Sheila: So that's really what we guide patients, what we guide really everyone to when we think about the primary end point for looking at the LITA trial and looking at the primary end point for that study. And then, of course, we will take that data to look at the phase three endpoints. And we will be looking at exacerbation, which is an individual component of the five composite endpoint score that we'll be looking at. And we'll be using that to guide our phase three planning and also to guide the exacerbation rate reduction we're hoping to see in the phase three trial. And, of course, this is all predicated on the fact that we are looking at the high e-adrenophilic population, and that's, again, been consistent with what we've been saying in terms of our ideal patient population from the beginning.

Hi, everyone to let me think about the primary endpoint for I'm looking at to lead a trial and looking at the primary endpoint for that study.

And then of course, what we will take that hated to look at the phase three and plays that we will be looking exacerbation, which is an individual component of the five composite endpoint score that we'll be looking at all using that to guide our phase three planning and also to guide the exacerbation rate reduction, we're hoping to see in the phase three trial.

And of course, it's a this is all predicated not we're looking at the height, yet, but it's a population.

That's again consistent with what we've been saying in terms of our ideal kitchen population from the beginning.

Okay. Great. That's helpful. Thanks, and then on Gpcrs are too I was hoping that you can provide us some more color on your current plans for this program.

Sheila: Okay, great. That's helpful. Thanks.

Joseph Patrick Schwartz: And then on GB002, I was hoping that you could provide us with some more color on your current plans for this program. I recall that Phase 1B has two cohorts. So, and you were previously thinking that you might start a Phase 2B3 based on the findings from the first cohort. Have you seen that data? Or is there any other rationale for what seems like a slightly different strategy now with a Phase 2 to start?

Recall that the phase wouldn't be has two cohorts. So how can you were previously thinking that you might start to phase to be three based on the findings from the first cohort have you seen that data or is there any.

Other rationale for Oh, what seems like a slightly different strategy now with a a phase two to start next year.

Sheila: Great question Joseph. So yeah, I think we are again looking to commence enrollment of patients this quarter. We did want to amend the study to include the open-label extension given the availability of our long-term toxicology data, and so we've done that. Our investigators are very excited to start enrolling patients and actually treating them beyond the two-week treatment period, and so we will be getting data from the 1B study really in the first half of next year, and we'll be able to report out on that data set, and that will be very much So we will be getting very important safety PK information and biomarker data and especially looking at NP, Pro B, and P levels, which we're excited to show that data in our preclinical models. We believe that we showed a nice reduction in our animal models looking at OO2 in those preclinical model settings.

Yeah, no great Great question, Justin So yeah, I think we we are again looking to commence enrollment of patients this quarter and we did one to amend the say to include the open label extension I've given the availability of our long term toxicology data. So we've done that our investigators are very.

I'd add ons to start enrolling patients and actually treat them beyond the two week treatment period, and so we will I be getting data from the one be I believe the first half of next year and we'll be able to report out on that dataset and that will be very much informing the phase two study design as well so we'll be getting very important safety PK information and buying.

Corporate data and especially looking at and people BNP levels, which were excited to show that data in our preclinical models. We believe that we showed nice reduction or animal model looking at over two in in the us in the preclinical models setting. So we'll be looking to see what data we can generate clinically as well in terms of my thinking of the state.

Sheila: So we'll be looking to see what data we can generate clinically as well. In terms of our thinking on the phase 2 strategy, I think we are, you know, we'll be looking at PBR again cardiac function as measured by echo and Pro B and P levels and other biomarkers as well as the six minute walk test. So overall, the study design is similar to what we have been planning all along. I think you know we are saying now that it will likely be a phase 2 study that may not be registration-enabling based on a lot of conversations we've had with regulatory authorities as well as key opinion leaders in this space and then compared to a phase 2b3 type of approach. However, again, we do think that the phase 2 trial will really position us for success in future registrational studies.

Q strategy I think we we're yeah, we'll be looking at PBR again cardiac function as measured by Echo and <unk>.

So BNP levels and other biomarkers as long as six minute walk test. So overall the study design is similar to what we have been planning all along I think you know we are saying now that there will likely be a phase two studies that may not be registration, enabling based on a lot of conversations we've had little regulatory authority this well okay well.

I'm in the space, you know and then to compare to what they to B to B type of approach. However, again, we do take a phase two trial will really positioned us for us for future Registrational studies and potentially more of its understanding and no again to further interactions and assessing a what's been going on the field for overall strategy, but.

Sheila: So it's really more of just understanding, you know, again, through further interactions.

Sheila: and they'll be assessing what's been going on in the field for our overall strategy. But basically, the study designs and our strategy from what we've been saying are still similar in terms of what we originally laid out.

Basically the they designs and our strategy from what we've been saying it is still similar in terms of what we originally laid out.

Great that makes sense, thanks for taking my questions.

Operator: Great, that makes sense. Thanks for taking my question. Thank you. Our next question or comment comes from the line of Patrick Trucchio from Berenberg Capital Markets. Your line is open.

Thank you our next question or counterculture line Patrick.

Churchill from Berenberg capital markets. Your line is it.

Hi, Mike often or this is Irish on for Patrick I'm. So congrats on the progress I have a few questions first on GPG Rosier, one just a follow up on the lead program can you tell us what date I should we expect to be release interim analysis and then secondly can you tell us what you would consider.

Iris Ahn: Hi, good afternoon. This is Iris Ahn speaking for Patrick.

Sheila: So, congrats on the progress. I have a few questions. First, on GB001, just a follow-up on the LIDAR program. Can you tell us what data should we expect to be released at the interim analysis? And then secondly, can you tell us what you would consider to be a comparable benchmark in terms of a particular study for a particular biologic that we should have in mind for the results of the LIDAR trial? And what should we anticipate in the composite endpoint based on the data generated to date? Thank you.

To be comparable benchmark and turns off a particular study for particular biologic that we should have in mind, what the lead <unk> results and when should we what should we anticipate the comp is the endpoint based on the data generated to date. Thank you.

Sheila: Thanks so much. So at the time of the interim analysis, that's again when about two-thirds of patients have reached 24 weeks and with the primary end point. We will be looking at the primary end point, which is the composite. And we'll be looking at the five subcomponents of the composite to ensure consistency.

Great. Thanks, so much on so at the time of the interim analysis and that's again, but about two thirds of patients had reached 24 weeks and with the primary endpoint, we will be looking at becomes the primary endpoint, which is a composite we'll be looking at the five sub components of the composite.

Sheila: And we'll really be looking at the rate of worsened events. So that's really the key end point that we'll be looking for in the study. We'll also look, of course, at lung function, and we'll be looking at safety and tolerability as well. Just to be clear, we will not be releasing any of this data since this will be an ongoing study, but we will be indicating whether we think the data is supportive of moving forward into phase three planning and initiation purposes. And so that's the level of disclosure we'll be providing. But really, what we'll be looking for is very robust data on the composite end point, consistency across all the subcomponents of the composite, and, of course, consistency with the secondary end point. So, in that regard, for benchmarking purposes, you know, we feel very comfortable looking at the data from the TAGEN study. Again, this would be in a different population, but if we're seeing, again, that improvement

To ensure consistency well, we're looking to be looking at the the rate of have worsened event and so that's really the key a endpoint that we'll be looking for this study. We'll also look of course that lung function and we'll be looking at stake and Tolerability as well I just to be a clear we will not.

Be releasing Adas data since its will be an ongoing study the who'll be indicating whether we think the data support of moving forward into phase three planning and initiation purposes, and so that's what they level disclosure will be providing but really but we'll be looking for is a very robust data on the composite endpoint consistency across all these.

Components of the composite and of course consistency with the secondary endpoint.

So in that regard for benchmarking purposes, you know, we feel very comfortable looking at the data from the Tagine study again. This is a being a different population, but if we're seeing again that improvement of the 30% to 50% type the improvement in and the reduction in worsening of then we'll feel it really comfortable.

Sheila: and others will feel very comfortable that we are in the ballpark. And we will have the benefit of seeing Novartis' totality of their phase III program, the LUSTR 1 and 2 data, which will help aid in our phase III planning, including statistical planning for those trials. And again, I will just guide individuals to look at the biological studies in their phase II trials. Again, these are looking at different endpoints. And with the anti-L5, they looked at exacerbation in phase II as well, and of course, that's one component of our overall composite. But again, we'll be looking at consistency across all these events. We can't really look at exacerbation solely in phase II as a primary endpoint just because of the event rates and that we won't have the number of events we need in a shorter term duration study and a smaller sample size. But again, these are all very correlated in terms of the worsening subcomponent, so it will give us a very good indication of how we think we will fare in phase III looking at a primary exacerbation endpoint.

We're in that ballpark and we will have the benefit of course is seeing the novartis totality of their phase three program, the lesser one and two data, which will help and aid in our phase three planning, including statistical planning for those trials and again I would just guidance as individual to look at the biologics studies and their phase two trial.

Yes again these are looking at different endpoints.

And that's outside they looked at exacerbations in phase two as well and of course, if that's the one component of our overall composite.

But again, we'll be looking at consistency across all these event, we can't really look at exacerbations solely in the phase two of the primary endpoint just because of the VAT refund and that we won't have the number of events, we need in a shorter term duration study and a smaller sample size, but that again abuja, you're all very correlated and much of the worsening sub component.

Instead, it'll be a <unk> it'll give us a very good indication as on how we think we will bear in phase three looking at a primary exacerbation endpoint.

[noise], Okay, a follow up question on Novartis that'd be a phase three program so be selling your discussions with the F.D. and fuel field trials.

Sheila: Okay, a follow-up question on VARDIS, the Phase III program. So, based on your discussions with the FDA and the zero trial failure, do you think that the FDA would require you to run a similar Phase III trial in moderate asthma patient populations with the lung function endpoint, or is it possible that this study could be avoided in your pivotal program?

Using <unk> ft would require you to run a similar phase three trial in moderate small patient population with the lung function endpoint or is it possible dot the study could be a white it in York pivotal program.

Sheila: Yeah, great question. You know, we have had conversations with the FDA where they were very interested in characterizing the efficacy of the product in a broader population beyond moderate to severe eosinophilic asthma patients. We definitely wanted to have that as our patient population for the Phase 2b ELITA study because we think that's where the highest and best scientific rationale lies in terms of the underlying biology of those patients and the potential therapeutic effect for CP2 antagonism as well as any Th2-related mechanism. But we do know that they are interested in that characterization.

Yes, Great question, you know, we have had conversations with the FDA, where they were very interested in characterizing the efficacy in a broader population beyond moderate to severe east NFL of Atlanta teach and we definitely want to have that as art mentioned my budget for the C. Tubular.

He just said he because we think that's where that HIF invest a scientific rationale lives into the underlying biology for this nation.

Therapeutic effect, where you could you antagonism as well as any THQ bleeding mechanism, but we do know that they are interested in that in that characterization and novartis has done quite a bit now to generate data and the moderate asthmatic than the mild to moderate setting as well as looking at the all comers and a lot.

Sheila: And Novartis has done quite a bit now to generate data in moderate asthmatics and in mild to moderate setting as well as to look at all comers in the LUSTER trial. So our plan is to continue to have a regulatory dialogue and to talk about that plan. You know, we're ready to receive the data from, again, our own ELITA study. Of course, we will look at the LUSTER 1 and 2 data sets when they become available and take all that back to the regulatory authorities to discuss and finalize our Phase 3 plan. I will say that if we are seeing clear benefit in the moderate to severe eosinophilic asthma setting and really not a lot of benefit in those other patient populations, we will try to streamline our Phase 3 program. We think that's the right thing to do for patients. We also think that it's the best use of the cost of resources as well. So those will be some of our...

After a trial so on our plan is to continue to have a regulatory dialogue.

Talk about that plan or no. We were written since even the data from again our own me to study of course, we will look at the luster wanting to Adidas estimate become available and take all that that can be a regulatory sorry to discuss and finalize our face you plan I will say that if we ever seen clear benefit in the months. The Verizon is of Adams and he is really not.

A lot of benefit in those other patient populations, we will try to streamline our Casey program. We think that's the right thing to do for patients and we also think that's the best he said the talking or resources as well. So I'm good that those will be some of our intention.

Okay. Another question on GBC or too so how should we think about the topline data into phase one study from both a safety and de risking perspective, particularly a safety impeached study something really that's a coat assets.

Iris Ahn: Okay, another question on GB002. So how should we think about the top-line data in the Phase 1B study from both a safety and a de-risking perspective? Particularly, a safety and pH study is really difficult to assess.

Yes, if they primarily to see the safety and Tolerability trial in getting experience and teenage patients and so that is the primary outcome measures for the study we will be looking at least biomarkers that we think can be very helpful and understanding clinical activity around the mechanism and that includes again imaging.

Sheila: Yeah, so I think primarily this is a safety and tolerability trial to get experience in PH patients, so that will be the primary outcome measure for this study. We will be looking at these biomarkers that we think can be very helpful in understanding clinical activity around the mechanism, and that includes, again, imaging parameters and looking at right heart function, as well as these probium P levels, which is a measure of right heart strain, and gene expression signatures, which will really be more direct evidence of our target engagement and our ability to neutralize the mechanism. So those will all be very encouraging, and a lot of that will be feeding into our exposure response modeling to finalize the dose selection for phase two, but, you know, we don't want to imply that we will be seeing proof of concept in the phase one B trial, really that it will be very helpful information for us to do a nice phase two study.

Parameters and looking at right heart function as well as these pro BNP levels, which is a measure of right Hearts train and gene expression signatures, which would really be more direct evidence of us a target engagement in our ability to neutralize the mechanism. So those are those all be very encouraging and a lot of that we'll be getting into our exposure.

Your response modeling on to finalize it does production curve for phase two and but you know it we don't want to guide that will be think proof of concept in the phase one be child labor there will be very helpful information for us to tubular to do a nice phase two study.

[noise] Thanks for taking my question.

Iris Ahn: Thanks for taking our questions.

Thank you again, ladies and gentlemen, if your unfortunately comment at this time. Please press Star then walk on your telephone keypad.

Operator: Thank you. Again, ladies and gentlemen, if you have a question or comment at this time, please press star then 1 on your telephone keypad. I'm showing no additional questions in the queue at this time. I'd like to turn the conference back over to management for any closing remarks.

[noise] showing no additional questions in the queue at this time I'd like to turn the conference back over to management for any closing remarks.

Thank you very much. Thank you everyone for valley all answer your questions and look forward to more dialogue over the next few weeks in quarters and thank you again.

Sheila: Thank you very much. Thank you to everyone for dialing in to the call and for your questions. I look forward to more dialogue over the next few weeks and quarters. Thank you again.

Ladies and gentlemen, thank you for participating in today's conference. This concludes the program you may now disconnect everyone have a wonderful day.

Operator: Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone, have a wonderful day! [inaudible]