Q1 2020 Earnings Call

Ladies and gentlemen, this is your operator your conference in scheduled to begin momentarily and so much on your lines will once again be placed on home. Thank you for your patient.

Operator: Ladies and gentlemen, this is your operator. Your conference is scheduled to begin momentarily. Until that time, your lines will once again be placed on. Thank you for your patience. BF-WATCH TV 2021, Ladies and gentlemen, thank you for standing by, and welcome to Gossamer Bio Inc.

Operator: Customer Q1 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Bryan Giraudo. Thank you. Please go ahead, sir.

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Ladies and gentlemen, thank you for standing by and welcome to the Gossamer borrow incorporated customers to one earnings conference call.

Bryan Giraudo: Thank you, operator. And thank you all for joining us this afternoon.

Bryan Giraudo: I am joined on today's call by Gossamer Bio's co-founder and chief executive officer, Dr. Sheila Guzrati. Earlier this afternoon, Gossamer Bio issued a press release announcing its financial results for the first quarter ended March 31, 2020, in addition to providing a corporate update. Please note that certain information discussed on the call today is covered under the Safe Harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, Gossamer Management will be making forward-looking statements. Actual results may differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Gossamer's news releases and SEC filings, including in the annual report on Form 10-K and subsequent filings.

At this time, all participants, earning listen only mode. After the spooky presentation. There will be a question and answer session. Twangy question. During the session you'll need to press star one on your telephone please be advise the tremendous conference is being recorded you require any further systems. Please press stars zero I wouldn't know.

I'd like to him a conference over to your speaker today, Brian Toronto. Thank you. Please go ahead sure.

Thank you operator.

Thank you all for join US. This afternoon I am joined on today's called like <unk> Co founder and Chief Executive Officer Dockers, She look who's writing.

Earlier this afternoon Gossamer bio issued a press release announcing its financial results for the first quarter added March 31st 2020 addition to providing a corporate update.

Please note that certain information disgust on the call today is covered under the safe Harbor provision of the <unk>, but Securities Litigation Reform Act, we caution listeners during this call Gossamer management will be making forward looking statements actual results may differ materially from those stated or implied buddies forward looking statements.

Bryan Giraudo: This conference call also contains time-sensitive 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 clinical studies, in addition to our ability to release results from our clinical trials in a timely manner, may be adversely affected by the ongoing COVID-19 pandemic. Gossamer Bio undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference. Now, I'd like to turn it over to Sheila. Sheila?

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

These forward looking statements are qualified by the statements containing Gossipers news releases N.S.C.C. filings, including the annual report on form 10, K. and subsequent violence.

This conference call also contains time sensitive 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 clinical studies. In addition to our ability to release results from our clinical trials any timely manner, maybe adversely affected by the ongoing cope in 19 pandemic.

Sheila: Thank you, Bryan, and good day to everyone joining us on today's call. Earlier this afternoon, Gossamer Bio was pleased to announce its financial results for the first quarter of 2020, in addition to several favorable updates on our pipeline of clinical product candidates. These include the completion of a pre-specified interim analysis for our LIDA phase 2b study of GB001 in moderate to severe eosinophilic asthma, as well as the release of top-line data from our completed phase 1b study of GB004 in patients with active ulcerative colitis. Beyond those, we have a number of other exciting updates to cover, so let's jump right in.

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

Now I'd like to turn over to Sheila Sheila.

Thank you Brian in good taste to everyone training I think today's com.

Earlier this afternoon Gossamer bio with please 10 now the financial results from the first quarter 2020. In addition to struggle favorable updates to our pipeline of clinical product candidates.

Is included the completion of the pre specified Intrim analysis for our leader faced you'd be study of G.B. 001, and moderate to severe easterner silk asthma as well as they release of top line data for a month from I completed face lumpy steady mtvs years, you're four and pieces of active altered <unk>.

Sheila: We will start with GB001, our once-a-day oral DPQ antagonist, which is currently being evaluated in two ongoing studies, the Phase 2B LIDA study in eosinophilic asthma and the Phase 2 TITAN study in chronic rhinocytis. We announce today that we have completed a pre-specified interim analysis of the LIDA study, which was based on approximately the first two-thirds of patients who either completed The Independent Data Monitoring Committee, or IDMC, reviewed results from the interim analysis and recommended the study continue as planned to its completion. As we have previously stated, given that this is an ongoing blinded study, we are unable to characterize the data further. We expect to report our top-line data when the study is complete in the second half of this year. The final decision to proceed to Phase 3 will be determined on the totality of the final data, as well as discussions with global regulatory authorities.

No it could be have a number of other exciting updates to cover so let's jump writing.

It will start with G.P. 001, I once a day <unk>, which is currently being evaluated and chew ongoing study the state to be read a steady and used to develop asthma and the <unk>.

We announced today that we have completed a pre specified interim analysis other lead a study which was based and approximately the first two thirds of patients who either completed or withdrew from the study.

The independent data monitoring committee or I.B.M.C. reviewed results from the interim analysis in a recommended this study continue its plan to its completion.

As we have previously stated given that this is an ongoing blind to study we are unable to characterize the data further.

We expect to report are tough blind data when the studies complete and the second half of this year.

The final decision to perceive 53 will be determined on the totality of the final data as long as discussions with global regulatory authority.

Sheila: Based on the results of the interim analysis and the IDMC recommendation, Gossamer has commenced initial Phase 3 planning and supportive activities. TB001 is also being studied in the Phase 2 Titan Study for the treatment of chronic rhinocytosis both with and without nasal polyps, which we had previously announced had completed its enrollment. We expect this proof-of-concept study will read out top-line data in the second half of this year. In both of our ongoing studies of GB001, we have implemented a number of mitigation plans to address potential challenges in study conduct due to COVID-19. These mitigations include virtual study visits, directed patient drug supply, and remote monitoring whenever needed. We remain confident that our top-line data timeline for GB001 will not be affected by the pandemic.

Based on the result that he interim analysis and the I.B.M.C. recommendation Gossamer had commenced initial safety planning and supported activities.

<unk> 001 is also being studied in the face to tighten study for the treatment upon mine status, plus with and without and use a pilot, which we had previously announced that completed at the moment. We expect is proof of concept study will beat up top line data and the second half that this year.

And both of our ongoing studies that you'd be 001, we have implemented a number of mitigation plan to address potential challengers steady kind that due to cook at 19.

Mitigation included virtual study visit directed patient drug supply and remote monitoring their whenever needed.

We remain confident that are top blind date, a timeline for T.V. 001 will not be affected by the pandemic.

Sheila: We are also excited to announce that in April of this year, the United States Patent and Trademark Office issued a new patent protecting aspects of the key drug substance forms being studied in clinical development at GB001. These salt compound claims further enhance the intellectual property protection surrounding GB001 and are not due to expire prior to 2037. We remain enthusiastic about the potential of GB001 to be a first-in-class oral treatment with an effect on clinical outcomes in the high unmet medical need of difficult-to-treat patients with moderate to severe asthma and other allergic diseases. We look forward to sharing top-line data from our two Phase II studies in asthma and chronic rhinocytes in the second half of the year. Next, we are excited to announce promising results from the Phase 1b study of GB004 in patients with active ulcerative colitis, or UC.

We are all excited turned out that in April this year, the United States patent trademark office issued a new Patton protecting aspect of the key drug substance form being studied in clinical development and she'd be thier one.

Salt compound clean further enhance the intellectual property protection surrounding G.B. 001, and are not due to expire prior to 2037.

We remain enthusiastic about the potential of G.B. 001, it'd be a first in class oral treatment with an effect on clinical outcome and be high unmet medical need at the as opposed to treat patients with moderate to severe asthma and other allergic diseases.

We look forward to sharing toppling data from our Tuesday to study and asthma in chronic right inside is the second half of the year.

Next we are excited to announce promising results from the faith, one B. study a G.B. 004 in patients with active also <unk> or you see.

Sheila: This Phase 1b was a four-week study to assess the safety, tolerability, and pharmacokinetics of GB004 in patients with mild to moderate UC. 34 patients with active disease, despite 5-ASA therapy, were randomized 2-to-1 to receive either a once-daily, 120-mg solution of GB004 or a placebo. As a reminder, GB004 is a potential first-in-class, gut-targeted, oral HIK1-alpha stabilizer for the treatment of IBD. Unlike immunosuppressants, such as anti-TNF antibodies and JAK inhibitors, which focus on reducing inflammation with corresponding well-known safety liabilities, TB004 is designed to support the repair and healing of the disrupted epithelial The stabilization of HIF-1 alpha leads to the expression of a number of genes associated with barrier function and integrity.

This phase one b. with a four weeks study to assess the safety Tolerability and pharmacokinetic gpcrs airports and pieces of mild to moderate you see.

34 patients with active disease. Despite 580 therapy were randomized <unk> either once daily 120 milligrams solution energy busier, you're for or placebo.

As a reminder, gpcrs. Your four is a potential first in class gut targeted oral just one office stabilizer for the treatment of I.B.D.

Unlike immunosuppressants, such an anti chain of antibodies and Jack inhibitors, which focused on reducing inflammation with corresponding volcanoes safety liabilities.

Do is your four is designed to support their repair inhaling the disrupted epithelial mining of the got.

Stabilization a hit one out that meets the expression of a number of genes associated with barrier function and integrity.

Sheila: As we entered into our Phase 1b study, in addition to evaluating safety and tolerability, we were hoping to see initial signs that GB004 was modifying these pathways through evaluation of gene expression and clinical outcomes such as mucosal healing and histology. TB004 was well tolerated in this study. The most common adverse events for patients on drugs were nausea and dysgustia, all of which were mild in severity, aside from one case of moderate nausea.

As we entered interface on B. study in addition to evaluating safety Intolerability, we were hoping to see initial sign for <unk> for modifying these pathways three evaluation of gene expression and clinical outcomes, such as me coastal healing and histology.

G.P. 004, it was well tolerated and the study.

The most common adverse events for patients on drugs were not yet and discuss yeah, all of which were modern severity aside from one chase a moderate knowledge Ya.

Sheila: All patients completed the study except for one patient who withdrew after experiencing a serious adverse event of worsening UC, which was deemed non-related to the study drug by the investigator. GB004 was rapidly cleared from the plasma, had minimal systemic accumulation over the four-week dosing period, and was found in significantly higher concentrations in the gut compared to plasma after eight hours of dosing. There was no impact on systemic EPO or VEGF levels.

All patients completed this study except for one patient who withdrew after experience a serious adverse event worsening you see which the dean non relates to study drive by the investigator.

<unk> 004 was rapidly clear from the plasma heightened minimal systemic accumulation over the four with guessing period was founded significantly higher concentrations and they've got compared to plasma after eight hours of their thing.

There was no impact on systemic eco or betcha level.

Sheila: These findings are consistent with a gut-targeted profile. We also observed evidence of target engagement in the gut; microarray-based mRNA expression profiling of gut biopsies showed an increase in genes consistent with enhanced epithelial barrier function, such as Claudin-1 and tight-junction protein 1, and other changes associated with HIF-1 alpha stabilization in the GB004 arm relative to the placebo arm. Initial immunohistochemistry data also showed a reduction in myeloperoxidase compared to placebo, suggesting a reduction in gut epithelial neutrophil activity.

Findings are consistent with it got targeted profile.

We also observed evidence of target engagement and the Guy.

<unk> m. or an expression profiling got biopsy showed an increase in jeans consistent with epic enhance epocal you Bury assumption, that's just caught in one and tight junction protein one and other changes associated with pick one alpha stabilization image <unk> or arm welcome to the placebo arm.

Initial.

Chemistry data also shows reduction a mile approximating compared to placebo, suggesting a reduction and got epithelial musical activity.

Sheila: And although this four-week first-in-patient study was neither designed nor powered for efficacy, we did observe favorable trends in the exploratory efficacy outcomes evaluated in the study. For example, while no cases of mucosal healing or clinical remission were seen in the placebo group, we saw instances of both in the GB004 arm. Four of 23 patients in the GB004 arm, or 17%, achieved mucosal healing, which in the study was defined as achieving both histologic remission and endoscopic improvement in either the sigmoid or rectum. Furthermore, 10 of the 23 patients receiving GB004, or 43%, achieved histological remission in either the rectum or the sigmoid as compared to 2 of 11 patients receiving placebo These data on mucosal healing and histologic remission are particularly encouraging as they suggest that GB004 is having a direct impact on gut epithelial healing at the cellular level after a short treatment period, which is consistent with the proposed mechanism of action.

And although this for weaker person patient study was neither design nor powered for advocacy we did their favorable trends on the exploratory advocacy outcomes evaluated in the study.

Well, no cases, and because the healing a clinical remission were seen in the placebo group. We saw instances of both in a G.B. 004 arm.

For a 23 patients <unk> for arm or 17% achieved Nicholson healing, which in the study was defined is achieving both because the logic remission and and it's got the improvement in either the sigmoid or rectum.

Further tended like 23 patients receiving jeebees, there's you're for or 43% and she took the logical remission and either the rectum or the sigmoid as compared to to have 11 patients receiving placebo or 18%.

These data and bicoastal healing mythological emission are particularly encouraging as they suggested she busy with your four is having a direct impact and got epocal healing at the cellular level. After a short treatment period, which is consistent with the proposed mechanism of action.

Sheila: We also observed favorable trends in our other traditional measures of efficacy in UC trials, such as clinical response, which was seen in 6 of 20 patients receiving GB004, or 30%, compared to 2 of 11 patients receiving placebo, or 18%. The rectal bleeding sub-score results also trended favorably, with 13 of 21 patients receiving GB004 showing improvement, or 62 percent, as compared to 5 of 11 receiving placebo, or 45 One patient in the GB004 arm achieved the high hurdle endpoint of clinical remission, while no patients in the placebo arm achieved clinical remission. We will present the full data from this study at a future medical conference. In this study and all prior clinical studies of GB004, a liquid solution formulation of the drug was used. After in-licensing the compound, we immediately began developing a tablet formulation of the drug to be used in future studies. Part of the reason for this was that we knew the high levels of cyclodextrin in the solution formulation could cause tolerability issues, limiting our ability to increase doses in the clinic.

We also observed favorable trends in our other traditional measures of advocacy and you see trout, such as clinical response, which was seen as six of 20 patients receiving a stupid user for a 30% compared to to have 11 patients receiving placebo or 18%.

<unk> still bleeding sat score of results also trying to favorably with 13 at 21 patients receiving jeebees user for showing improvement or 62%.

<unk> 511, receiving placebo or 45%.

One patient and that you'd be 004 arm it cheap the high fertile endpoint of clinical or mission long no patience and that's pretty bill arm achieve clinical remission.

We'll presented both data from this study at a future medical conference.

In this study in all prior clinical studies that you'd be there for a liquid solution formulation of the drug was used.

At your end licensing the compound we immediately began developing a tablet formulation other drugs to be used in future studies.

Part of the reason was before this was that we knew the high level to Cyclodextrin and the solution formulation could cost tolerability issues limiting our ability to increase this isn't the clinic.

Sheila: In parallel to this study, we successfully completed a Phase I in Healthy Volunteers to support the selection of a tablet formulation. In that study, we were able to increase doses with favorable PK and without the tolerability concerns seen with the solution form. Despite a short four-week dosing duration and a potentially non-optimized dose, these are promising early results, and our advisors have encouraged us to move into a robust Phase II study. We plan to commence a 12-week induction study evaluating higher doses of GB004 in patients with ulcerative colitis in the second half of the year, barring an unforeseen delay related to the ongoing COVID-19 pandemic. We also announced this afternoon that we have amended our license agreement concerning GB004 with Aeropio Pharmaceuticals. Gossamer paid Airpo $15 million up front, and in exchange, Gossamer received more favorable downstream economic terms, including lowering our remaining milestone obligations from $400 million to $90 million. Royalties on net sales also decreased from rates ranging in the high single digits to mid teens to royalties ranging from low single to mid single digits.

In parallel to the study we successfully completed a phase one in healthy volunteers to support the selection of a tablet formulation.

And that study, we were able to increase do with favorable P.K. and without the child barely concern seem a solution farm.

Despite a short for with Josee duration in a potentially non optimize Joe's user promising early results and our advisers have encouraged us to move into a little but faith to study.

We planted commenced a 12 week induction study evaluating higher doses of where the toughest format. You could do is your for patients with ulcerative quite as in the second half of the year.

An unforeseen delay related to the ongoing covered 19 pandemic.

We also announced this afternoon that we had the mended or license agreement concerning <unk> before with air P. a pharmaceutical <unk>.

<unk> airfield $15 million, a front end in exchange Gossamer see more favorable downstream economic terms, including learning a remaining mouth and obligations from $400 million to $90 million <unk>.

<unk> Dot net sales also decrease from rates amazing and the high singled there just to me team to royalties ranging from low Singleton mid single digits.

Sheila: This upfront investment reflects our enthusiasm for GB004 and its potential to emerge as a unique treatment option for patients with IBD. Next, let us move on to GB002, our inhaled PDGFR inhibitor for the treatment of pulmonary arterial hypertension, or PAH. TB002 was designed to improve upon prior success observed with kinase inhibition and PAH by delivering a potent PDGFR inhibitor directly to a site of disease with a convenient dry powder inhaler, all while avoiding high systemic exposures and improving the therapeutic index.

It's upfront investment reflect our enthusiasm for T.V. 004, and his potential to emerge as a unique treatment option for patients with I.B.D.

Let's let's move on to G.B.'s do as your to our inhaled prodigious bar inhibitor for the treatment of pulmonary arterial hypertension R.P.H.

She was yours or to the design to improve upon prior success observe with tiny says rubbish, an M.P.H. by delivering a polling P.G.F.R. inhibitor directly to the side of disease. It convenient drypowder inhaler, all while avoiding high systemic exposures and improving the therapeutic index.

Do you could <unk> study, an ongoing dose ranging phase one beat trial and peach patients.

Sheila: GP002 is currently being studied in an ongoing dose-ranging Phase 1b trial in pH patients. As a reminder, the objective of this two-week study is to evaluate the safety and PK profile of GB002 in patients. While we had an encouraging start to enrollment, given the ongoing COVID-19 pandemic, enrollment in this Phase 1b trial was temporarily paused. We are hearing from our investigators that there is potential to restart enrollment in late May. For that reason, we have decided to keep the trial open longer to see if we can gather additional data.

As a reminder, the jacket this to be study it to evaluate the safety and P.K. profile, a G.B. 002 impatient.

Well, we had an encouraging started kind of moment given the ongoing covered 19 pandemic enrollment into space going to be trapped with temporarily pause.

We are hearing from our investigators.

His potential just you start involvement in late May for that reason, we have decided to keep the <unk> the longer to see if we can gather additional data.

Sheila: We are therefore shifting our guidance for initial data from the study from Q2 to the second half of 2020. We have launched study startup activities for our Phase 2 study of GB002 and anticipate beginning involvement in the second half of this year, subject to further developments related to the COVID-19 pandemic. We have received excellent receptivity on our proposed Phase II plans from a number of investigators, and we believe there is tangible excitement building for its commencement. This 24-week Phase 2 study will enroll PAH Functional Class 2 and 3 patients. Patients will stay on background therapy throughout the study, including during the process cycle.

We are there for shifting our guidance for initial data from this study from choose to to the second half the 2020.

We have watched study started activities for days to study and see these years, you're too and it's typically pay beginning involvement in the second half of this year subjective further developments related to the club at 900 pandemic.

We have received excellent receptivity under propose faced you plans from a number investigators and we believe there's tangible excitement building first commencement.

It's 24 week based you study will involve P.H. functional class she went three patients.

Well stay on background therapy throughout the study, including cross the cycling.

Sheila: The primary endpoint will be a change from baseline in PVR at week 24, and the key secondary endpoint will be a change from baseline in 6 minute walk distance at week 24. GP-1275, our oral CD11B modulator being developed for the treatment of solid tumors, continues to advance through dose escalation in the Phase 1-2 keynote A36 trial, where it is being studied as monotherapy as well as in combination with pembrolizumab or with chemotherapy in patients with select solid tumors. No dose-limiting toxicities have been observed to date in the study, and despite the challenges observed with COVID-19, the trial continues to be on track and to enroll new patients. Later this month at the American Society of Clinical Oncology virtual meeting, we will present initial data in solid tumors from both monotherapy and combination therapy with pembrolizumab. The results consist of early safety PKPD and biomarker data that are consistent with the GB1275 mechanism of action and its impact on myeloid-derived suppressive cells.

The primary endpoint will be a change from based site and P.D.R. a week 24, and a key secondary endpoint will be changed from baseline and six minute walk distance at least 24.

Hebrew 12, 75, or oral C.D. 11, B. modulator being developed for the treatment of solid tumors.

He needs to advance it goes escalation in the phase one two key note 836 trial, where it is being studied as monetary as well as in combination with <unk> or with chemotherapy impatience with select solid tumors.

No just limiting toxicity happiness or to date and the study and despite the challenges observe it covered 19, the chocolate she needs to be on track and turn bold new patients.

They use this month at the American Society of clinical psychology virtual meeting, we will present initial data in solid tumors from both Monotherapies and combination therapy with pen believes in that.

The result consists of early safety P.K.P.D. and by America data, which are consistent with the G.B. 12, 75 mechanism of action and its impact on Milo derive depressive so.

Sheila: Please be on the lookout for that virtual poster during the ASCO 2020 Virtual Scientific Program from May 29th through May 31st. Additionally, when we are able to do so, we will make the poster available on our website at gossamerbio.com in the poster and publication section. In addition, we will present updated data from the study in the second half of the year. Finally, we are happy to announce that GB1275 has now received orphan drug designation from both the EMA and the FDA for the treatment of pancreatic cancer.

Please be on the lookout for that virtual poster during the after 2020 virtual scientific program from May 29th you may 31st.

When we were able to do so we all make the poster available on her website I got my bio dot com and the poster in publications section.

In addition, we will present updated data from the study and the second half of the year.

Finally, we were happy so now that you'd be 12, 75 and is now receive orphan drug designation and but the M.A.M.B.F.D.A. for the treatment of pancreatic cancer.

We also have a corporate update to share.

Sheila: We also have a corporate update to share. Dr. Jacob DuPont will be departing his position as Chief Medical Officer of Gossamer in June of this year to pursue opportunities in oncology closer to his home in the San Francisco Bay Area. We are thankful for his services and wish him the best of luck in his future endeavors. Dr. Dupont will remain a consultant for Gossamer and continue to support the clinical development of GB1275. Our Senior Vice Presidents, Dr. Richard Aranda, Karen Peterson, and Heather Smith, and Vice President Matt Kravitz will join me in taking over Jacob's responsibilities.

Dr. Jacob Dupont will be the party with position as Chief Medical Officer of Gossamer in June of this year to pursue opportunities that on college, you closer to his home and the San Francisco Bay area, We're thankful for services and wish him the best of luck in the future endeavors.

I could do felt were made a consultant for gossamer and continue to support the clinical development of G.B. 12 75.

Or senior Vice Presidents Doctor budget, Aranda, carrying Peterson, and Heather Smith, and Vice President Mac rabbits, but joined me and taking over Jacobs responsibilities.

Sheila: Before we discuss our financial position, I want to quickly address the ongoing viral pandemic and how it relates to Gossamer. Gossamer takes the safety and health of its patients, partners, and employees seriously. And to that end, we have put procedures in place to minimize risk. Despite the physical and practical limitations imposed by COVID-19, the majority of operations in Gossamer continue unabated, including the advancement of multiple research programs in our portfolio, which we're excited to discuss further at a future date. This progress is in large part due to our incredible employees who remain focused on our shared mission. Given the tireless efforts of our employees and our strong balance sheet, we believe Gossamer remains well positioned to navigate these challenging times. With that, I will hand it over to Gossamer Bio's Chief Financial Officer, Bryan Giraudo, for a financial update.

Before we discuss our financial position I want to quickly address the ongoing bio pandemic and how it relates to gossamer.

Customer takes a safety and health of his patients partners employees seriously and to that and we have put procedures in place and minimize risk.

Basic physical and practical limitations imposed becca they'd 19, the majority of operations in Gossamer continue unabated, including the advancement of multiple research programs in our portfolio, which were extended to discuss further at a future date.

This progress is a large part due to our incredible employees germane focused on her share admission.

Given the tireless efforts of our employees and our strong balance sheet, we believe gossiper remains well positioned to navigate these challenging time.

With that I will handed over to Gossamer bio Chief Financial Officer brand your idea for financial update Brian.

Thank you Sheila.

We will know review the financial results for the first quarter of 2020.

We ended the quarter with $346 million cash in cash equivalent.

Bryan Giraudo: Thank you, Sheila. We will now review the financial results for the first quarter of 2020. We ended the quarter with $346 million in cash and cash equivalents. We continue to anticipate that our 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 until mid-2022. Research and development expenses in the first quarter of 2020 were approximately $41.4 million as compared to R&D expenses of $25 million for the same period in 2019. This reflects...

We continue to anticipate or cash cash equivalent and marketable securities along with the access toward that.

Revitas sufficient capital resources to fund operations in capital expenditures until mid 2022.

Research and development expense and the first quarter of 2024, approximately $41.4 million as compared to Orange expensive 25 million for the same period in 2019.

Flux.

Increase reflects they continued wrap up a critical expenses related to our critical programs and increased expenses related to the development over proprietary preclinical programs.

In process R. and D. expenses in the first quarter of 2020 were approximately $2.8 million as compared to 1 million for the same period in 2019.

G.N.A. expenses were $10.7 million in the first quarter as compared to generate expenses of 8 million for the same period in 2019.

Bryan Giraudo: This increase reflects a continued ramp-up of clinical expenses related to our clinical programs and increased expenses related to the development of our proprietary preclinical programs. In-process R&D expenses in the first quarter of 2020 were approximately $2.8 million, as compared to $1 million for the same period in 2019. G&A expenses were $10.7 million in the first quarter as compared to G&A expenses of $8 million for the same period in 2019. And our net loss for the quarter was $54.1 million, equating to $0.87 per share. For the same period in 2019, we reported a net loss of $32.6 million, which equated to $0.90 a share. With that, I'll turn the call back over to Sheila to offer closing comments before we open the line for Q&A.

<unk> lost for the quarter was $54.1 million waiting to 87 cents per share.

Same period in 2019 reported a net loss of 32.6 million, which equated to 90 cents for sure.

<unk> altering the call back over to she looked to offer closing comments before we open the line for doing it Sheila.

Thank you Brian.

I'd be close descriptive portion of this call I would like to take a moment to personally think those who have contributed so far to the success of gossamer.

From the patients and their clinical trials to our values investigators advancing the field and medicine.

Investors, who have bought into our shared mission and finally to our employees who are working diligently everyday in the lab or virtually at home.

<unk> efforts have enabled gossamer to pursue at school of enhancing and extending the life that patients.

Thank you all.

With that I will now turn the call over to the operator for question operator.

Thank you this time I would like to remind everyone in order to ask a question.

<unk>.

Number one on your telephone keep <unk>.

We will pause for just a moment to come home with you when a roster.

Sheila: Thank you, Bryan. As we close the scripted portion of this call, I would like to take a moment to personally thank those who have contributed so far to the success of Gossamer. From the patients in our clinical trials, to our valued investigators advancing the field of medicine, to our investors who have bought into our shared mission, and finally, to our employees who are working diligently every day in the labs or virtually at home, your valiant efforts have enabled Gossamer to pursue its goal of enhancing and extending the lives of patients.

Your first question comes from a one or just from Bank of America. Your mind is open.

Hi, guys is Sylvia Brown for draft. Thanks, so much for the questions and congressional the progress today can you give us a little more insight into what went into that interim go now go decision for G.B.O. one.

You know was there a level of clinical reduction that was methods that really ultimately drove that recommendation.

And when you think about success in the face straight you know are you looking for somewhere threshold versus versus what was meant and that seems to enter thanks. So much.

Thank you yeah, yeah, well the interim just to be clear was pre specified in planned as an administrative analysis.

Operator: Thank you all. With that, I will now turn the call over to the operator for questions. Operator.

And that we were basically looking at the totality of the data on the primary and secondary I think at the end point 50 Intolerability.

Operator: Thank you. At this time, I would like to remind everyone, in order to ask a question, please press star, then the number one on your telephone keypad. We will pause for just a moment to compile the Q&A room. Your first question comes from the line of Jeff Meecham from Bank of America. Your line is open. Hi guys, this is Olivia Braron from DREF.

It wasn't really designed to adjust anything significantly for the study having said that of course whenever you do the analysis you'd you'd look at all the efficacy and safety and the I.D.M.C., which is a very season group of really pulmonary respiratory expert take a look at that data and and ultimately good termination so which.

Olivia Braron: Thanks so much for the questions and congratulations on all the progress today. Can you give us a little more insight into what went into that interim go-no-go decision for GBO-01? Was there a level of clinical reduction that was met that really ultimately drove that recommendation? And when you think about success in phase three, are you looking for a similar threshold versus what was met in that phase two interim? Thanks so much.

Could look at the clinical outcomes that we we're measuring and they're very pleased that we actually designed her face to study truly focus on those clinical outcomes that are most important isn't relevant for phase three including exacerbation and so that the type of data set that they were able to take a look at and the first two thirds of patients and were again very please and encourage.

Recommended to continue on with this study to study completion and so very very much keeping that in mind about what is what is our faith three point, we're going to be looking at and that Stacy decision. I think this study puts us in a very good position to make that file this decision.

Sheila: Thank you, Olivia. Yes.

Sheila: Well, the interim, just to be clear, was pre-specified and planned as an administrative analysis in that we were basically looking at the totality of the data on the primary and secondary efficacy endpoints, safety, and tolerability, and it wasn't really designed to adjust anything significantly for the study. And so that's the totality of the data set that they were able to take a look at in the first two-thirds of patients, and we're, again, very pleased and encouraged that they recommended continuing on with the study to completion. And so we're very much keeping that in mind about what our Phase 3 endpoints are going to be looking at in that Phase 3 decision, and I think this study puts us in a very good position to make that final decision.

<unk> comes from Milan of Joseph Schwartz from a <unk>.

Right.

I was wondering if you could talk a little bit about what else should look for.

For.

Making.

Final vote.

You could characterize.

More.

It's like you'd like to gain from.

Oh.

<unk> well, it's really around continuation of study in the maturity that continued evolving maturity of the data set with.

Total emphasize that we're looking at again for the advocacy M. clean.

Joseph Patrick Schwartz: Your next question comes from the line of Joseph Schwartz from SBB Lyrinc. Your line is open. Great, thanks, and congrats on the great job.

Secondary in Queens as well as a again the safety intolerability aspects that it's really around looking at all of all of the data on the pool.

Joseph Patrick Schwartz: I was wondering if you could talk a little bit about what else you'll look for in the totality of the data.

480, P.C. plus that you know, we'd emboldened to the study which is that the full sample size, though continuing to make sure that you know all of these things are you know reading out. So it's it's again that evolution that you get from a full data set versus an interim data set. So that's really what will be containing took to look at and evaluate.

Operator: [inaudible]

Sheila: 001 when making your final vote on a decision. You can characterize what

Sheila: Yeah.

Sheila: Insight you'd like to gain from the data set, that would be

Sheila: Helpful. Thank you.

Sheila: Help us all! Thank you.

Okay that makes sense.

Sheila: Sure. Well, it's really around continuing the study and the continued evolving maturity of the data set with the total sample size that we're looking at, again, for the efficacy endpoints, secondary endpoints, as well as, again, the safety and tolerability aspects. So it's really around looking at all of the data on the full 480 patients plus that we enrolled into the study, which is the full sample size. So it's continuing to make sure that all of these things are reading out. So it's, again, that evolution that you get from a full data set versus an interim data set. So that's really what we'll be continuing to look at and evaluate.

So do you foresee any children's too.

Evaluation.

Right.

<unk>.

Yeah, that's actually no. We're actually we put into me as this medication plans as I I've mentioned were feeling very confident they won't have not only a high speed.

<unk> for those remaining ancient but good quality as well in terms of the data collection and monitoring silver feeling very comfortable about being able to complete the study and actually be able to really see it to completion to the final analysis.

Sounds pretty to look forward to seeing the.

Right.

Thanks Justice.

<unk> comes from Milan.

No from the Cantor Fitzgerald your ones open.

Hey, I think so much for taking the question and you can grasp on all the progress at different times of the U.C. data can you help us think about what the next steps would be per gpcrs here or you know in terms of thinking about the potential Max study and I guess, what data you wouldn't want to see to further d. rest the asset before you'd be.

Sheila: Okay, that makes sense, thanks. And then, do you foresee any challenges to completing the evaluations for the last third of the patients enrolled in LIDA, given what's going on in the world?

Sheila: Yes, actually, no, we've actually put in so many risk mitigation plans, as I've mentioned, we're feeling very confident that we'll have not only a high rate of completion for those remaining patients but good quality as well in terms of the data collection and monitoring. So we're feeling very comfortable about being able to complete the study and actually be able to really see it through completion to the final analysis.

Comfortable moving forward into a phase three study and then definitely on the U.C. program I guess just in terms of your preclinical modeling or perhaps maybe from the initial clinical data you know what is this the <unk> the length of time it would take we got to sort of the peak Africa see.

Sheila: Sounds great!

Sheila: That sounds great. I look forward to seeing the whole data. Congratulations.

Ellie Merrill: Thanks, Joseph. Your next question comes from the line of Ellie Merrill from Cantor Fitzgerald. Your line is open.

So basically I mean, do you think that like asking would move from say four weeks to eight week or qual week in an induction study I guess, one would you expect to get to that Ah peak sort of level of apathy thing.

Sheila: Hey guys, thanks so much for taking the question and congrats on all the progress. Just in terms of the UC data, could you help us think about what the next steps would be for GB004, you know, in terms of thinking about the potential next study and, I guess, what data you would want to see to further de-risk the asset before you'd be comfortable moving forward into a Phase III study? And then secondly, on the UC program, I guess just in terms of your preclinical modeling or perhaps maybe from the initial clinical data, you know, what does this suggest in terms of the length of time it would take to get to sort of peak efficacy? So basically, I mean, do you think that as you would move from say four weeks to eight weeks or 12 weeks in an induction study, when would you expect to get to that peak level of eff Thanks.

Right no. Thanks for the questions. Yeah. So we're again very pleased with our faith must be data and that to look at the the the clinical at because the outcomes that we're seeing already in for a week.

Gives us again dot com to to move forward into the phase two now we're going to be doing a more Baba phase two induction study this is going to be at 12 feet.

They're really give us again additional time to be able to assess the impact and induction. The fact that we're already seeing it back and histologic permission and bicoastal healing.

It again very encouraging for us anything typically reduce the earlier about histology than than you could see on some of the other clinical parameters. So it's it's very nicely with the mechanism of action.

<unk> four and again these are very meaningful endpoint, the unmet need and you see it's really around because the healing and and improvements in histology. That's that's really kind of what we're trying to draw with this.

Sheila: So now we're going to be doing a more robust Phase 2 induction study. This is going to be a 12-week trial to really give us, again, additional time to be able to assess the impact on induction.

A friend she didn't mechanism looking at at facility or barrier, <unk> repair and healing and function and so again just to have this type of data already a four week, where we think we're probably have to lower means of the death exposure. We'd like to study is very encouraging. So now will be going forward into that more robust they too will be.

Sheila: The fact that we're already seeing effects on histologic remission and mucosal healing is, again, very encouraging for us. And typically, you do see earlier effects on histology than you can see on some of the other clinical parameters. So it fits very nicely with the mechanism of action for GB004.

Looking at additional measures.

Such as the clinical response permission and because he had to look at and because the healing into effect on just allergy and based on that we'll we'll be able to make a final three decision, but I think we're in a very good position and are going into that trial with a good degree of confidence as it around the the peak time, I mean, I think that's really where everything.

Sheila: And, again, these are very meaningful endpoints. The unmet need in UC is really around mucosal healing and improvements in histology. That's really kind of what we're trying to address with this differentiated mechanism looking at epithelial barrier repair, healing, and function. And that does seem to correlate, again, well with all the data we're seeing preclinically in terms of our impact on gene expression profiles as well as what we're seeing in terms of the gut mucosal lining. So I think, you know, if anything, I think we're giving ourselves more time to really make sure we have a good effect. So I feel comfortable with the 12-week induction period.

Going for 12, we conduct she said he will give us enough time.

Really evaluate induction if that we're seeing good advocacy at four weeks. So I think that'll improve over time over the next eight just there were giving ourselves it because he just be good effect in that induction settings. So we're still pretty comfortable with that.

That does seem to correlate again, while with all the data were sitting preclinically in terms of or impact on gene expression profiles as well as what we're seeing in terms of the got <unk> I'm. So I think you know anything I think we're getting ourselves more and more time to really make sure. We have a a good effect. So I feel comfortable with the 12 week induction period.

Oh, yes, it's very.

Sheila: Yeah, very exciting. Thank you, Alicia. And then, in terms of the CT11D program, can you elaborate a little bit more on the biology and why pancreatic cancer? If that's the focus, is there anything particular to the target and sort of that tumor type and biology there? Thanks.

Right.

Oh.

Grabs you a lot running a little bit more.

Yeah.

Pancreatic cancer at the focus is there anything particular to the <unk> humor type and biology there.

Yeah, and just to be clear so yeah. This is <unk>.

Sheila: Yeah, and just to be clear, so yeah, this is a really interesting mechanism that goes after more immunosuppressive mechanisms within oncology, and it's a great combination approach with checkpoint inhibition, so we're really affecting the myeloid suppressor cell types, such as the tumor-associated macrophages and other MDSC cells, both granulocytic and monocytic, all of which really contribute to the immunosuppressive phenotype, especially for select tumor types where you have primary and secondary resistance to checkpoint inhibitors, and we impact not only the trafficking of these cells from the periphery into tumors themselves, but we also view the polarization to a more immunosimilatory phenotype away from that immunosuppressive M2 phenotype for macrophages, so again, there's kind of a, potentially several mechanisms at play for this mechanism, and to that regard, we are studying a number of other tumor types outside of pancreatic cancer, so while we have gotten orphan drug designation for pancreatic cancer, we actually are studying a number of other areas, such as prostate cancer, colorectal cancer, triple negative breast cancer, other areas where, again, we see, you know, gastric cancer, maybe low rates of checkpoint response, as well as, again, a lot of mechanisms of resistance, which we think are very related to the myeloid biology I've spoken to, so we have a number of different tumors that we're studying in the phase one dose escalation period through both combination cohorts, monotherapy cohorts, as well as the cohorts with chemotherapy, so with that, Louisa, do you have anything else to add on the mechanism and our thoughts about tumor types? I think you've covered most of it, Sheila, I mean, one of the things we have seen as well is in mechanisms of secondary resistance that not only you have the immunosuppressive effect, you also have, as you know, some fibrotic effect in stromal and we believe this mechanism could actually address this as well, so as Sheila mentioned, we believe in secondary resistance there is an opportunity in quite a...

Really interesting mechanism that goes after more immunosuppressive mechanisms within oncology and it's a great combination approach with checkpoint inhibitions. So we're really affecting the <unk> type such as the tumor associated Mac or five there's another M.D.S.C. so granules <unk> all the.

It's really contribute to immunosuppressive phenotype for for especially for like favorite tumor case, where you have primary and secondary resistance to checkpoint inhibitors, and we impact not only be trafficking of t. cells from the periphery into tumors themselves.

Either polarization to a more immunostimulatory thing that type away from that immunosuppressive and to phenotype for for macro flashes. So again, because they just several mechanism that play.

This.

<unk>.

Two that regard as we are sending a number of other killer type outside of patriotic cancer. So while we have gotten or urban drug designation for pancreatic cancer, we actually are cutting a number of other areas such as prostate cancer.

Colorectal cancer Triple negative breast cancer other areas, where again, we see you know gastric cancer may be low rates of checkpoint a response as as well as again lost a lot of mechanism resistance. As we think are very related to that my like biology I've spoken to so so we are have a number of different.

Humor that we're studying in the phase one dose escalation period through both combination cohorts monetary cohorts as well as a cohort with chemotherapy.

So with that.

Do you have anything else to add on on the mechanism and our cost about tumor type.

Oh, I think you covered most like she'll the I mean, one of the things, we I've seen as well and in mechanism <unk>.

That's a a lot and not only you have the immunosuppressive attacks. You'll also have as you know <unk> and we believe this mechanism could actually address as as well so.

We believe in checking their resistance as an opportunity in a.

Sheila: and we are definitely looking for biomarkers in this study that will help us then really

Wide range of tumors as well and we definitely looking for them by a marketing decided that will help us and then really okay on the rise patients <unk>.

Sheila: and the Wright patients for subsequent studies. Very helpful. Thanks so much. Your next question comes from the line of Carter Gould from Barclays. Your line is open.

Very helpful. Thanks, so much.

[noise] costumed comes from alone.

<unk>.

Carter Lewis Gould: Great. Good afternoon. Congratulations on all the progress. Thanks for taking the questions. Start with question 001 first.

Right.

Congressional progress.

Questions.

Burke with on 001 first.

Sheila: Can you maybe just talk now, as you think about that sort of go-no-go decision in going potentially into phase three, just kind of where you're sort of setting the internal bar from a high level in light of the obvious Novartis data late last year? And I guess to follow up on that question as well, maybe just kind of clarify when we get the top-line data, it sounds like we may not get a go, no-go decision at that point. Is that kind of where our expectation should be set? I guess reading the PR, it sounded like you would still kind of meet with regulators at that point. I guess level set expectations there.

Can you maybe just talk now.

About that sort of go no decision in in.

Into a phase three just kind of where you're for sort of setting the.

Turtle bar from from a high level in light of the obviously, Nevada stayed on late last year I guess follow up on the on that and I question as well, maybe just kinda clarified that around when we get the top line data. It sounds like we may not get it could go no go decision at that point <unk> that kind of where the.

Our expectations.

The P.R.

So what kind of meet with regulators at the at that point of different I guess levels that expectation.

Sheila: Yeah, so great questions. And I think I'd like to remind everyone about, you know, the intention of this program again is to be an oral treatment for patients with moderate to severe asthma, where there is so much high unmet need that there are at least 60% of patients who are not controlled today with moderate to severe asthma that are really on high dose or medium dose inhaled corticosteroids, plus one or even two other controller medications. And that's the population that we enrolled into our clinical trials. So what we're really looking to see is a good impact on clinical exacerbation, which is the provable phase three endpoint. So from that, from that perspective, we've done a lot to talk about what we think our efficacy could be for these types of oral mechanisms and what would be very acceptable to patients, providers, and payers.

Yeah, So great questions and you know I think I liked it remind everyone about you know the intention of this program again is to be an oral treatment for patients with moderate to severe asthma, where there's so much unmet need there's at least 50% of patients who are not control today with <unk>.

In here as in that that are really on hide it goes from medium does inhaled corticosteroids plus one or even two other controller medications not the population that we enrolled into our clinical trial. So what we're looking to see is a good impact on clinical exacerbation, which is that provable say three endpoint.

From that from that regarding we've done a lot to talk about what we think are advocacy could be for these types of oral mechanism. So what would be very acceptable to patients providers in Paris, and you know again, that's really the range that we have been talking about Empire discussions, we've talked about anywhere to 20% to 30%.

Sheila: And, you know, and that's really the range that we have been talking about in prior discussions, we talked about anywhere between 20 to 30% of exacerbation reduction. That was something that we were looking for and targeting. As you recall, Novartis has mentioned information in that regard as well. And they did have that in the lecture two data that they reported out. So it's a very interesting area of all. And this is something we'll continue to monitor and measure in our clinical trials, as well as, you know, as we continue the maturation of the study. Looking at these very important clinical endpoints and being able to really design our studies correctly using the correct assumptions from a statistical perspective. So I think there are a lot of very interesting developments that are occurring that we can really capitalize on and make sure that we're making the best decision for the phase three decision.

Up exacerbation reduction says something that we were looking for and targeting I do recall <unk>.

And in that regard as well and they did have that in the last year two data that that they have reported out. So it's a very interesting if all the area with somebody will continue to monitor and and measure in our clinical trial that as well as you know as we continue that the maturation of the study.

In addition to that I think you know it is important that we do our homework around understanding other just count even novartis data. When it is released as you've probably heard the Americans breath Society is now going through a virtual meeting presentation. So we'll see what additional data we get on a heavy pippin program used to publication.

Presentation to see how much we can learn from that program as well as again, our own interactions with global regulatory authority. In addition to looking at the top line in final data coming out delete a trial to really make a very well informed decision since we have more time now to really make sure that <unk>.

Sheila: Great. And then maybe just one follow-up on 004, going into the dose escalation phase. I guess maybe based on your preclinical models, do you have a sense, sort of, of the target dose, or maybe another way of asking that when you think about sort of, you know, the level which you could push the dose up to, any insights from the preclinical models there? I'm just trying to get a sense for maybe the number of doses you might evaluate in the Phase II study.

<unk> so that we can design the most robust safety program moving forward. It can take all this information to really make sure. We have a very bulk up three program and plan for phase three and four and buy health authority interaction as well as a lot of learning looking at these very important clinical EM.

Quaint and being able to really designer studies correctly using the correct assumptions on from this fiscal perspective. So I think there's a lot is very interesting.

Sheila: Yeah, that's a great question. So I think we're in a really good position for the next study. We have a very good preclinical colitis model that we've done. This is really under Louisa's and her research team's leadership and expertise. She's a true expert in really any animal models, but especially these IBD colitis models, to sing her praises.

Developments that that that are occurring that we can really capitalize on and make sure there were making them. The best decision for the phase three decision.

Great and then maybe just one one follow up on her for going into the goes escalation I guess maybe.

Nickel models do you have a sense sort of on the target those four.

When you think about sort of you know.

Sheila: And, you know, we have some very good data that kind of helps guide our dose selection based on the exposures that we're achieving for efficacy in those animal models. We have a lot of information from our phase one normal healthy volunteer studies with both the solution and the tablet formulation that we recently completed. Normal healthy volunteers, which is not only looking at systemic concentrations but colonic concentrations, and both, again, the solution and the tablet formulation studies because we did sigmoidoscopies and were able to get colonic biopsies to really measure tissue concentration there, which was very helpful to really show that we had a greater colonic concentration than peripheral exposure. That also helps guide our decisions, as well as, of course, the phase 1B 28-day study now with not only biomarker data but also the clinical data that we discussed.

But you could push push that goes up to three.

Any insights into preclinical model therapist trying to get a sense for maybe the number of those as you might evaluate in the 50 study.

Yeah. No question, so I think wearing a really good position for the next study we have a very good preclinical lightest model.

That we've done have you can really under the reason and her research teams leadership and expertise that she's a true expert and really any animal models, but let's see these these I.B.D. collected models the thing her praises.

And you know we've had some very good data that kind of help guide art or does it selection based on the exposure that were cheating for advocacy and those animal models. We have a lot of information from our phase one normal healthy volunteer studies with both the solution and the tablet formulation that we recently completed normal healthy volunteers and just not only looking at the standard.

Concentrations colonic confrontations and both began to solution and the topic correlation studies, because we did actually sigmoid off the bees, and we're able to get kalata biopsies to believe measure tissue concentration there, which is very helpful. Jubilee showed that we had a greater colonic consecration bend a peripheral exposure that also helps guide or decision.

Sheila: So, we have a really nice set of data to guide what we want to do moving forward in terms of dose exposure, dose levels, as well as the formulation that we want to take forward. So, we can make decisions based on the target levels, and we can come back and discuss all of that at a future date after we're finished analyzing the data. But I think we're in a really good position to help us select the doses for phase 2. Thank you.

As well as of course is based on the 28 days study now with the only biomarker data, but also that clinical data that we discussed so we have a a really nice head of data to guide what we want to do moving forward <unk> exposure dose levels as well as the formulation that we want to take four so.

We can make decisions based on the target levels and we can come back and discuss all of that at a future date. After we were finished the analyzing the data, but I think we're.

Good position to help us select the doses for for the phase two.

Thank you.

<unk>, Oh, <unk> or new lines open.

Tyler Van Buren: Your next question comes from the line of Tyler Van Buren from Piper Sandler. Your line is open.

Tyler Van Buren: Great. Thanks. Good afternoon.

Right. Okay. Good afternoon, they see the process had so long as usual for.

Sheila: Great to see the progress. Had some on 004. I guess in the release you mentioned multi-fold higher gut concentrations. Is it possible to quantify the difference or the increase in gut concentration there? And then, with respect to the clinical observations, there's clearly some activity here, but as we've looked at other effective agents, for example, Theravant's topical jack, you're seeing, I guess, similar numbers. So is there, I guess, anything as you look at the data that stands out as kind of more clearly differentiated, maybe with respect to the histology, or are we going to have to wait for the Phase II 12- And then just finally, as we think about clinical development, it sounds like you're describing a fairly traditional Phase II UC study. So is it possible to differentiate the program from a clinical development standpoint moving forward, just given the unique mechanism here?

In the Luis you mentioned multi polled higher.

<unk> is it possible to quantify.

Thanks for the increasing the good concentration there.

Then the on with respect to the critical Activations discreetly some activities.

<unk>.

Affected agents for example, <unk> talk we'll Jack.

I guess.

Similar numbers. So we can just anything that you looked at the data that stands out.

Kind of more clearly differentiated maybe with respect to them.

Oh, Gee or or we didn't have to wait for the phase 212 week induction study and then just finally, we think about clinical development sounds like you're describing a clearly traditional phase two you see studies so.

Impossible to differentiate would program from a clinical development standpoint, moving forward just given the unique mechanism here.

Yeah, No I think we can talk about all three of those questions.

Sheila: Yeah, no, I think we can talk about all three of those questions. And I'll actually ask Richard Aranda, who's on the call with us today, who is a gastroenterologist, who's been involved with many IB development programs, including Ozanamod with me at Receptos, to talk a little bit about the exposures in the colon versus the periphery, so he can address that. In terms of the other two, I'll take those, and again, Richard can bolster that or Louisa.

And I'll actually ask Richard Aranda Who's on the call with this today, who is it gastroenterologist who's been involved with many I'd be development programs, including those animals with me at Receptos.

Talk a little bit about that that exposures in the end the call and versus the the periphery. So he can address that.

The other two I'll I'll take this into getting richer can bolster that are Louisa yeah. We we are really compelled with it <unk> yeah and you look at this arrogant data that they published in the journal Crow Politesse. The J.C.C. in the in a much time frame, where they had it it really makes robust publication.

Sheila: Yeah, we are really compelled by the 1B data, and when you look at the TheraAdvanced data that they published in the journal Crohn's and Colitis, the JCC, in the March timeframe, they had a really nice, robust publication evaluating a lot of the similar outcomes that we've been evaluating. And we do seem to be in line with what they've shown in their one-month Gut-Targeted JACK program, which is, again, very exciting from our perspective. I think the one area of difference that, again, we're focused on here is because we have a differentiated mechanism looking at the epithelial barrier of repair and function, we do seem to have, again, more mucosal healing and histologic remission. That's a potential problem.

<unk> evaluating a lot of similar outcomes that we've been evaluating and we do seem to be in line with what they parties, but they've shown in their one month, you know got targeted Jack program, which again is very exciting from our perspective, I think that one area of different that again, we're focused on here is because we have a different.

Entry to mechanism looking at the at the Sillier barrier every parent's function, we do seem to have again more bicoastal healing and just a logical mission and that's the potential now they didn't measure technology in their program and so they did not a report bicoastal healing from the traditional definition, that's the regulatory definition.

Sheila: Now, they did measure histology in their program, and so they did not report mucosal healing from this traditional definition. That's the regulatory definition of endoscopic improvement and histologic remission, or patients who've met the criteria for histologic remission. So we don't know for certain, but that wasn't reported in their publication. So that may be just a distinction that we have in terms of targeting JACK versus really going after this differentiated mechanism. Potentially, it could be a complementary mechanism as well.

And as Coppock improvement and his a logic revision or patients who've met the criteria just the logic condition. So we don't know for certain but that wasn't report out in their publication.

That that maybe it just a distinction that we have in terms of targeting jock versus really going after this differentiating mechanism potentially could be a complimentary a mechanism as well. So I think we were pretty excited not only is a monotherapies, but potential ways to add into complimentary fashion, given that where a non.

Sheila: So I think we're pretty excited, not only as a monotherapy, but potential ways to add in a complementary fashion, given that we're a non-immunosuppressant type mechanism and potentially could combine safely with other mechanisms. So more to come on that front, but we are already seeing potential differentiation with our mechanism versus potentially some of the other immunosuppressants. So that's something that we thought was notable.

Immunosuppressant mechanism and potentially could go by combined safely with other mechanisms on some more to come on that front, but we are seeing already potential differentiation with our our mechanism versus potentially some of the other in many suppressant. So that's something that we thought was notable and I think our clinical data seems to be.

Sheila: And I think our clinical data seems to be in line with what we've seen with that four-week study, as well as other programs where we've looked at four- to eight-week induction periods, where we're seeing, again, some things that are in line, especially at that four-week time period. And then for clinical development, I think, yeah, we are very focused on getting to the definitive proof of concept. I think one area that we are excited about differentiating for is really looking at the patient population. So given, basically, that this is a differentiated gut epithelial type-directed mechanism, and we're hoping to have continued good safety and tolerability, we're very interested in moving this up into earlier lines of treatment. So we're focused on continuing to study this mechanism in the mild-to-moderate setting, which would really differentiate it from other immunosuppressants, including the other orals that are being developed or recently approved, but because of safety liabilities, they have been relegated to more moderate-to-severe disease.

Line and what we've seen with that four weeks study as well their programs, where we've looked at four to eight week induction periods, where we're seeing again something better in line I'm associate that for the time period.

And then for clinical development I think yeah. We we are you know very focused on you know getting to that you know definitive proof of concept I think one area that we are excited about differentiating four is really looking at the patient population. So different basically that this is a differentiated got epitaxial type directed mechanism.

And we you know we're hoping to have continued good think intolerability, we're very interested in moving this up into earlier lines of treatment. So we're focused on continuing to study. This mechanism in the mouth moderate setting we should really differentiated from other immunosuppressants, including the other oral better I'm being developed or or recently been approach.

Where because of safety liabilities and you know they had been relegated to more moderate to severe disease. So this is an area, where we think we can truly differentiate from the clinical development program and then we'll be assessing I'm looking at a lot of similar and points from that regard this will be a differentiated program than other moderate to severe offered a quite a.

Sheila: So this is an area where we think we can truly differentiate from the clinical development program. And then we'll be assessing and looking at a lot of the similar endpoints from that regard. But this will be a differentiated program from other moderate-to-severe ulcerative colitis programs. With that, Richard, do you want to add some other information, especially on the colonic exposure?

Programs.

But that rich or do you want to add on some other information, especially on the clonic exposure.

Sure. So would I can add to she was comments is just want to remind you that we okay biopsies at eight hours after the dos.

Richard Aranda: Sure, so what I can add to Sheila's comments is that I just want to remind you that we obtained biopsies at 8 hours after the dose. And at that time point, the systemic levels of OO4 were quite low, in the single-digit nanogram concentration. And I also want to remind you that in tissue biopsies, looking at drug concentrations, there's a lot of variability. Nonetheless, in that setting, we consistently see significantly greater concentrations that are far above the single-digit and from a nanogram per ml perspective, that we see in the circulation. And just to add to that, the concentrations we see are also consistent with what is achieved in some of the animal models that have been conducted with our compound by our research group, and those concentrations are associated with efficacy.

And at that time point to systemic levels of all four is quite low.

In in the single digit not a gram concentration and.

I want to remind you that in tissue biopsies of looking at drug concentrations, there's a lot of variability.

Nonetheless in that setting we consistently see significantly greater concentrations that are far above the single digits.

Oh and from an underground for a Mel perspective that we see in the circulation.

And just to add to that the concentrations. We see we see are also consistent to what is achieved in some of the animal models.

Oh that has.

Been conducted with our compound or by our research group and those concentrations are associated with advocacy.

Richard Aranda: Great. Thanks so much. Very helpful. Once again, if you would like to ask a question, please press star, then the number one on your telephone keypad. Your next question comes from the line of David Hong from SMB. Your line is open.

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Hey, guys. Thanks for taking the questions and congrats on getting the Green lights moved forward with.

David Hong: I had a few questions on Gb002. So recently, I think earlier this year, Acceleron had some positive data with their compounds, the tatter sets, and I know that was a phase two study where they looked at PVR and six minute walk distance. I think they also have another study where they're looking at oxygen consumption, so peak VO2 or VO2max. So I guess, you know, my question is, do you think you need to look at anything else besides PVR and six-minute walk distance, you know, in terms of secondary or exploratory endpoints, you know, to help ensure a competitive profile for 002 in PAH?

I had a few questions on G.D.O. two.

So I know I knew recently I think earlier this year Acceleron pets.

With their compounds attached herself and I know that was it pays to study where they looked at a P.D.R. in six minute walk there.

I think they also have another study where they're looking at oxygen consumption, so ti vo too or via to match.

So I guess you know my question is do you think you need to look at anything else. Besides.

Six minute walk.

Secondary or exploratory endpoints, yeah to help ensure at a competitive profiles.

P H.

Sheila: Yeah, I'll start that, and I'll also ask Richard to provide some comments. So I think, clearly, this is also another area of very high unmet need. We're going after patients who are having significant disease, the functional class 2, 3, and 4, so they're very significantly with significant disease severity and symptomatology despite being on two or three classes of vasodilator therapies. So really all the available therapies that are available to them today. So the ERA, the PDE5 class, and the process cyclin class, particularly.

Yeah, I'll I'll start that and I'll also which are to to provide some some comments. So I think crow like this is also another area very high unmet need we're going after patients who are having significant disease functional class.

Two three and four that to they're very you know significantly which is you never disease severity and system apology.

Despite being on two or three classes of days or dilator therapy really all that available therapies that are available to them today. So.

The P. five class and the cost the second class.

Particularly.

Sheila: And we have data obviously with a matinib here in that same group of patients; 50% of the in-prep trial patients were on process cyclins and IV process cyclins at the time when we saw this really improved clinical benefit looking at PVR reduction and six-minute walk distance. So in and of itself, to look at those clinical functional outcomes of an improvement in six-minute walk distance as well as the objective endpoint of PVR reduction, these are really critical endpoints in the setting of PAH. And these are also, as you know, the six-minute walk distance is the approvable endpoint or one of the approvable endpoints for PAH.

And.

We have food, obviously with a matinee up here in that same group of patients 50% to impress trout pieces were on profit psychos, an I.D. <unk> because of the time, where we saw this really improved clinical benefit looking at.

Reduction walk distance. So yeah. This up to look at those clinical functional outcomes I've been improvement is six minute walk distance as well as the sector. Then point a P.D.R. reduction these are really critical and playing in the setting a P.H. and you know these are all these you know the six minute walk is is is the provable endpoint.

Of the approval been points for for for a P.H. So those are really the ones that were very focused on if we dated for our fate you design and you know we had that the hoop into thinking that this could be a disease modifying therapy. We have a lot of great preclinical data that really supports that and we have a lot of cross talk with actually this is.

Sheila: So those are really the ones that we're very focused on and have stated in our phase two design. And we have the hope and the belief that this could be a disease-modifying therapy. We have a lot of great preclinical data that really supports that. And we have a lot of crosstalk with actually this is a TATRSEP mechanism that Richard and Louisa could speak to, which really gets to, again, the underlying biological improvement that we're seeing preclinically, definitively within our animal models and what we think we could show clinically. And including We've seen an increase in BMPRQ signaling in our preclinical models as well. So I think those are what's critical. In addition, we have a number of other biomarkers that we're looking at, and we're gonna be looking at echocardiography imaging, and looking at right ventricular function, and looking at ProBNP levels ourselves as a measure of right heart strain to kind of get at, you know, really how we're affecting right ventricular function. And then we have some exploratory measures that we'll be looking at that really could get at the So with that, maybe I'll ask Richard to say a few words, and maybe Luisa can comment on some of the biology that we're so excited about with our mechanism.

<unk> mechanism that Richard and lose that could be two which really get to again, the underlying biology improvement that we're seeing preclinically definitively, but in our animal model and what we think we could show clinically.

And including we've seen increase in B.M.P.R. two signalling in our preclinical miles as well. So I think those are are with critical.

In addition, we have a number of other biomarkers that we're looking at and we're going to be looking at Echocardiographer imaging looking at bright ventricular function and looking at pro B.N.P. levels ourselves as a measure of right Heartstream. That's the kind of get at you know really how're were affecting right ventricular function and then we have some explorer.

Measures that will be looking at that really could get at potential for disease be modeling.

Without any they'll ask a richer to say a few words and and maybe losing comment on some of the biology I that we're so excited about with our mechanism.

Richard Aranda: Sure, I'll say a few words just to add to Sheila's comments. So, as you may know, CPET, or Cardiopulmonary Exercise Testing, is not yet validated as an endpoint for PAH. As Sheila mentioned, the key sort of endpoints required for approval still remain a six-minute walk, as well as evidence of a reduction in pulmonary vascular resistance. CPIT is being used and explored to see if there could be other non-invasive methodologies to determine, first of all, a diagnosis of pulmonary hypertension, but also whether it could be used as a measure to determine therapeutic benefit. So I still think it's a little bit too early to say that CPIT can be used in the absence of the other endpoints. However, it can be considered sort of supplemental if some of the data that's coming out on its use in some other programs seem to be suggestive that it can add some additional information.

Sure I'll tell you a few words just to add to she was comments. So as you may know she could see pets or cardiopulmonary exercise testing.

Not yet validated does and 0.4 P.H. Sheila mentioned, the key sort of end points required for approval still remain.

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Secret is being used in explorer to see if there could be other non invasive methodology to determine first of all diagnosis of former hypertension, but also could it be used as a measure to determine therapeutic benefit so I I still.

Think it's a little bit too early to say that she could.

<unk> be used in the absence of the other end points. However is it can be considered as sort of supplemental if.

Some of the data that's coming out on it's used in some other programs seemed to be suggested that it.

Can add some additional information.

David Hong: Got it. Thanks. That was that was really helpful. And I think I just, you know, have one follow up in terms of the the phase 1b data, you know, when we eventually get that, I know that it's a, I think it's just a two week study you have there and you do have some exploratory end, So maybe, you know, just to help kind of set expectations, you know, in terms of BNP and ejection fraction, you know, over a two-week period, you know, should we kind of expect to really see much there or, you know, I guess, you know, how much efficacy do you think you can obtain on those measures with just two weeks of treatment?

Got it.

Was really helpful.

Yeah, I have one follow up in terms of.

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I I know that it's a I think it's just a two week study you have there and you do have some exploratory endpoints.

So maybe you know just to help can set expectations, you know terms, a B.M.T. and junction fraction you know over a two week period, you know it should we kind of expect you really see much there were.

How much do you think you could you can obtain on those measures with just two weeks of treatment.

Yeah. It's a two week. This is definitely a short duration period. So we basically yeah. This is the study this designed to look at safety Tolerability target engagement, some biomarker and Pharmacodynamic work as well as started to look at somebody's exploratory outcome measures I think.

Sheila: Yeah, so two weeks is definitely a short duration period. So basically, you know, this is a study that's designed to look at safety, tolerability, target engagement, some biomarker and pharmacodynamic work, as well as start to look at some of these exploratory outcome measures. So I think we're very keen on understanding some of the target engagement and biomarker work coming out of that study, and, of course, looking at the safety PK to continue to help us guide our dose selection for phase two, which is really critical in understanding safety and tolerability in pH patients, in addition to normal healthy volunteers where the drug was very well tolerated. And we saw good PK consistent with our limited systemic exposure profile, which is really what we're trying to go after with this local lung delivery.

We're very keen on understanding some of the target engagement and by America, we're coming out of that that study and of course looking at the <unk> continue to help us guide or destruction for phase two which is really critical undressing pick intolerability impeach patience and it just into normal healthy volunteers for the drug was very well tolerated and we saw.

Good P.K. consistent with our limited systemic exposure a profile, which is really what we're we're trying to go after with this local lung delivery. So I do want to temper expectations on what we could be seen from the clinical activity perspective. In this case you know we are hoping to have some pieces role into an open label extension.

Sheila: So we do want to temper expectations of what we could be seeing from a clinical activity perspective. In this case, you know, we are hoping to have some patients roll into an open label extension where maybe we could follow them for longer periods of time. So that's an area where we could get some more clinical data looking at some of the echocardiogram measures, as well as some of these other biomarkers, especially NT-ProBMP. So more to come, you know; this is really, again, depending on how the COVID situation continues to evolve and if we're able to really get patients into the clinic safely. I mean, our primary responsibility is to make sure that these PH patients who are quite sick are really, their safety is really paramount in terms of making sure that we don't increase their risk for COVID infection. So that's really what we're focused on.

Maybe it could follow them for longer periods of time, So that's an area, where we could get some more clinical data looking at some of the echocardiographic measures as most of them that are biomarkers, especially empty probing p. Some more to come you know yeah. This is really good depending on how the code that situation continues to involved and we're able to really get patients.

Into the clinic safely I mean, our primary responsibility is make sure that.

H patients who are quite sick are really you know their safety is is really paramount in terms of Nick because you don't increase or risk to the covered infection. So that's really what we're focused on.

Okay right, thanks for taking questions.

Sheila: Okay, great. Thanks for taking the question. There are no further questions at this time. I turn the call back to the presenters for closing comments.

Verno for the <unk>.

Well. Thank you again, so much for joining us on our call today I'm. So pleased with the tremendous progress <unk> <unk> customers, making on a number of our clinical program's really all four of our clinical programs to date as well as a whole research portfolio therapeutic what we're looking for kids to be able to speak to you about shortly.

Sheila: Well, thank you again so much for joining us on our call today. I'm so pleased with the tremendous progress Gossamer is making on a number of our clinical programs, really all four of our clinical programs to date, as well as a whole research portfolio of therapeutics that we're looking forward to being able to speak to you about shortly, which is a very exciting pipeline of candidates in areas we know very well. I want to thank the Gossamer employee base for their continued hard, tireless efforts in challenging times and really continue to advance all of our programs in such a high quality manner. I look forward to continuing the dialogue with investors and shareholders and continuing to help meet the unmet needs of patients and their families. Thank you so much.

Which is very exciting pipeline of candidates in areas, we know very well.

I want to thank the gossamer employee based further continued hard tireless efforts and challenging times and really continued to advance all of our program. It's such a high quality manner I look forward to continue the dialogue with investors in shareholders.

Continue to help support meeting the unmet need for for patients and their families. Thank you so much.

Operator: That concludes today's conference call. You may now disconnect.

But concludes today is called from coal.

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