Q1 2025 Gossamer Bio Inc Earnings Call
Unknown Executive: And ladies and gentlemen, and welcome to the Gossamer Bio Q1 2025 earnings call.
Good afternoon, ladies and gentlemen, and welcome to the Gossamer Bio Q1, 2025 earnings call I will now turn the program over to Brian Gerardo, Chief Financial Officer, and Chief operating Officer.
Bryan Giraudo: I will now turn the program over to Bryan Giraudo, Chief Financial Officer and Chief Operating Officer. Thank you, operator. And thank you all for joining us this afternoon.
Thank you operator, and thank you all for joining US. This afternoon I'm joined on today's call, but for heme has named customers founder Chairman and Chief Executive Officer, Dr. Richard Aranda, Chief Medical Officer.
Bryan Giraudo: I'm joined on today's call by Faheem Hasnain, Gossamer's Founder, Chairman and Chief Executive Officer, Dr. Richard Aranda, Chief Medical Officer, Karen Peterson, Executive Vice President, Regulatory Affairs, and Bob Smith, Chief Commercial Officer.
Peterson: Peterson Executive Vice President regulatory Affairs, and Bob Smith, Chief Commercial officer.
Bryan Giraudo: Earlier this afternoon, Gossamer Bio issued a press release announcing its first quarter 2025 financial results and provided a corporate update.
Speaker Change: Earlier this afternoon Gossamer bio issued a press release announcing its first quarter 2025 financial results and provide a corporate update please.
Bryan Giraudo: 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 the 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 statements contained in Gossamer's news releases, SEC filings, including the annual report on Form 10-K, and subsequent filings.
Peterson: 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 the 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 Companys business.
Peterson: These forward looking statements are qualified by statements contain Gossipers news releases SEC filings, including the annual report on Form 10-K, and subsequent filings. This conference call. Also contains time sensitive information that maybe accurate only for a limited period of time Gossamer bio undertakes no obligation to revise or ups.
Bryan Giraudo: This conference call also contains time-sensitive information that may be accurate only for 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 call.
Peterson: Any forward looking statements to reflect events or circumstances. After the date of this conference call now I'd like to turn it over to Pete.
Faheem Hasnain: Now, I'd like to turn it over to Faheem. Thank you, Bryan. Good afternoon, everyone.
Faheem Hasnain: And welcome to our first quarter 2025 earnings call. We're very excited to provide an update on the significant progress and momentum with serolutinib, which is an investigational treatment for pulmonary hypertension, including pulmonary arterial hypertension, or PAH, and pulmonary hypertension associated interstitial lung disease, or PHILD. So over the past year and a half, we at Gossamer have dedicated immense time, effort, and hard work to enroll our pivotal PAH study, the Phase III procerus. In particular, I want to recognize the efforts of our global clinical operations, development, and field medical team, who quite literally have been working across the globe around the clock to get us to this point.
Speaker Change: Thank you Brian Good afternoon, everyone and welcome to our first quarter 2025 earnings call.
Speaker Change: We're very excited to provide an update on the significant progress and momentum with Sarah Loopnet, which is an investigational treatment for pulmonary hypertension, including pulmonary arterial hypertension or P. A H and pulmonary hypertension associated interstitial lung disease or P. H I L D.
Speaker Change: So all through the past year and a half we at Gossamer has dedicated at mens time.
Speaker Change: And hard work to enroll our pivotal study the phase III <unk> study.
Speaker Change: In particular I want to recognize the efforts of our global clinical operations development and field medical team, who quite literally have been working across the globe a round the clock to get us to this point today I'm incredibly proud to announce that we have achieved a significant milestone in the <unk>.
Faheem Hasnain: Today, I'm incredibly proud to announce that we have achieved a significant milestone in the PROCERA study with a closure of new patient screening. And while nearing completion of enrollment is a significant achievement in and of itself, what really matters is enrolling the correct patient population to best position Procera for a successful outcome. In this case, that successful outcome is a demonstration of a significant treatment effect in six-minute walk distance at 24 weeks. Now, with this context in mind, we're thrilled to report that the baseline characteristics of the patients enrolled thus far are precisely what we have targeted, and we are more optimistic than ever about the likelihood of achieving positive results, but I'll dive more deeply into that in a moment.
Speaker Change: With the closure of new patient screening.
Speaker Change: Yeah.
Speaker Change: And while nearing completion of enrollment is a significant achievement and itself what really matters is enrolling to correct patient population to best position <unk> for a successful outcome.
Speaker Change: In this case that successful outcome is the demonstration of a significant treatment effect in six minute walk distance at 24 weeks.
Speaker Change: With this context in mind, we're thrilled to report that the baseline characteristics of the patients enrolled thus far are precisely what we had targeted and we are more optimistic than ever about the likelihood of achieving positive results.
Speaker Change: I'll dive more deeply into that in a moment.
Faheem Hasnain: This year, we've experienced great momentum in rolling the study, as growing appreciation of the 72-week TORI open-label extension data from patients and physicians sparked strong interest in the PROCERA study. Given this late additional surge of interest, the PROCERA study has a substantial number of patients currently in screening. And when those potential patients are added to the already 343 patients already enrolled or scheduled to randomize, there are more than enough patients to complete full enrollment by early June. We owe the PAH community a great deal of gratitude for entrusting us, and we will honor that trust by allowing every patient in screening the opportunity to enroll in the Procera study if they qualify.
Speaker Change: This year, we've experienced great momentum enrolling this study as growing appreciation of the 72 week Tory open label extension data from patients and physicians sparked strong interest in the <unk> study.
Speaker Change: Given this late additional surge of interest are Sarah study has a substantial number of patients currently in screening.
Speaker Change: When those potential patients are added to the already 343 patients already enrolled or scheduled to randomize.
Speaker Change: Im more than enough patients to complete full enrollment by early June.
Speaker Change: We owe the P. A H community a great deal of gratitude for entrusting us and we will honor that trust by allowing every patient in screening the opportunity to enroll in the <unk> study if they qualify.
Faheem Hasnain: While we expect to complete the blinded portion of the study, including the 24-week, 6-minute walk distance primary endpoint by the fourth quarter of this year, we anticipate announcing top-line results in February 2026. This timeline ensures that we can lock the database and thoroughly clean, analyze, and adjudicate the substantial data collected in this robust 48-week double-blind study without sacrificing data quality or operational expertise.
Speaker Change: While we expect to complete the blinded portion of the study, including the 24 week six minute walk distance primary end point by the fourth quarter of this year.
Speaker Change: We anticipate announcing topline results in February 2026. This timeline ensures that we can lock the database and thoroughly clean analyze and adjudicate the substantial data collected in this robust 48 week double blind study without sacrificing data quality or operational X.
Faheem Hasnain: Let's now review in detail the baseline characteristics of those enrolled in ProSERA and how this patient population helps set up serolymph no. 4 success. Now, the learnings from the Phase 2 TORI study helped us to identify specific patient characteristics that would likely respond favorably to serolute. by carefully selecting patients with impaired six-minute walk. and elevated risk at baseline through use of the Reveal Light 2 risk score and other criteria, we aim to enroll a population where a greater magnitude of effect could be seen on the six minute walk distance at 24 weeks, which is the primary endpoint, thereby increasing the likelihood of success of Procera.
Speaker Change: <unk>.
Speaker Change: Let's now review in detail the baseline tariffs characteristics of those enrolled in pro Sarah and how this patient population helps setup Cheryl that NIM for success.
Speaker Change: No the learnings from the phase II Tory study helped us to identify specific patient characteristics that would likely respond favorably to Charlotte.
Speaker Change: By carefully selecting patients with impaired six minute walk distance and elevated risk at baseline through use of the reveal light to risk score and other criteria. We aim to enroll a population where greater magnitude of effect could be seen on the six minute walk distance at 24 weeks, which is the <unk>.
Speaker Change: Maryann point, thereby increasing our likelihood of success of pro Sarah.
Faheem Hasnain: I am happy to say that given the baseline characteristics that we've seen thus far, the eligibility criteria was successful in enrolling the exact intended patient population.
Speaker Change: I'm happy to say that given the baseline terrorist or characteristics that we've seen thus far the eligibility criteria was successful in enrolling the exact intended patient population.
Faheem Hasnain: Let's take a closer look at the baseline characteristics. those that are currently available to us of the first 324 patients enrolled in the ProSera study as of May 12, 2025. It's important to remember that this 324 patient number is distinct from the previously mentioned 343 patients, which includes additional patients that randomize after the May 12th date and patients that are scheduled. To start, we find that the average six-minute walk distance is approximately 376 meters, much lower than the Taurig baseline, where six-minute walk distance averaged 408 meters. For comparison, the phase three STELLAR study of Cetatracept had a baseline six-minute walk of 401 meters.
Speaker Change: Let's take a closer look at the baseline characteristics of those that are currently available to us of the first 324 patients enrolled in the <unk> study as of May 12, 25.
Speaker Change: It is important to remember that this 324 patient number is distinct from the previously mentioned 343 patients which includes additional patients that randomized. After the May 12 date and patients that are scheduled to be randomized.
Speaker Change: To start.
Speaker Change: We find that the average six minute walk distance is approximately 376 meters much lower than the Tory baseline or six minute walk distance average 408 meters for comparison the phase III stellar study of <unk> had a baseline six minute walk up for.
Faheem Hasnain: Second, our mean NT Pro BMP, which is an important biomarker of heart failure, is 986 nanograms per liter in Procera, which denotes a materially more severe population than the TORI study, where the mean NT Pro BMP levels were only 628 nanograms. For additional reference, Cytatracept Stellar Phase 3 had a baseline mean NT-PRO BMP of 1,121 nanogram per liter, nearly double what we enrolled in TORI, and much more similar to what we are seeing in the baseline characteristics of Procera.
Speaker Change: <unk> hundred one meters.
Speaker Change: Second our mean NT pro BNP, which is an important biomarker of heart failure is 986 nanograms per liter and Sara.
Speaker Change: Which denotes a materially more severe population than the Tory study, whereas a mean NT pro BNP levels were only 628 nanograms per lease.
Speaker Change: For additional reference Cid tattersall stellar phase III had a baseline mean NT pro Pnp of 1121 nanogram per later nearly double what we enrolled in Torrey and much more similar to what we are seeing in the baseline characteristics of pro Sarah.
Faheem Hasnain: Third, let's address the functional class. Consistent with other precedent, positive PAH trials In our phase 2 TORI study, serolutinib demonstrated a larger magnitude of effect in the functional class 3 patient. But a functional class imbalance in the treatment arm versus the placebo arm created what we believe was a major limiting factor in the magnitude of effects seen on the six-minute walk distance in that study. While the placebo arm was 52% functional class 3, the serolutinib arm only had 32% of its patients classified as functional class 3 at baseline in the Tauris In contrast, 74% of the patients currently enrolled in our ProSera study are categorized as Functional Class 3 at Bayside.
Speaker Change: Third let's address the functional class.
Speaker Change: Just as with other precedent positive P. A H trials.
Speaker Change: Our phase II <unk> studies, Cerro Lindo demonstrated a larger magnitude of effect in the functional class III patients.
Speaker Change: On a functional class imbalances the treatment arm versus the placebo arm created what we believe was a major eliminating factor in the magnitude of effect seen on six minute walk distance in that study.
Speaker Change: While the placebo arm was 52% functional class III, the Cerro Loopnet arm only had 32% of its patients classified as functional class III at baseline inventory study.
Speaker Change: In contrast <unk>.
Speaker Change: 74% of the patients currently enrolled in our <unk> study are categorized as functional class III at baseline.
Faheem Hasnain: a significantly larger portion than in Torrey. We will also have a higher proportion than the STELLAR study, which mandated that at least 50% of its patients be functional Class III and ended up enrolling 51% of these Class III patients.
Speaker Change: Significantly larger portion of that inventory.
Speaker Change: We will also have a higher proportion than the stellar study, which mandated that at least 50% of its patients be functional class III and ended up enrolling 51%.
Faheem Hasnain: And to prevent an imbalance, we have incorporated a stratification factor for functional class to ensure a balanced population between the arms. Now, Why are we spending so much time walking through these baseline characteristics? Well, in short, study after study in PAH has shown us that patients who are sicker at baseline, those with more room to improve, tend to have better outcomes, particularly on the six minute walk distance in a 24 week study. We saw this in Torrey, where patients with higher baseline reveal risk scores than those with functional class 3 disease had a much more dramatic improvement in their six minute walk and their.
Speaker Change: Of these of these class III patients.
Speaker Change: And to prevent an imbalance we have incorporated a stratification factor for functional class to ensure a balanced population between the arms.
Speaker Change: Now.
Speaker Change: Why are we spending so much time walking through these baseline characteristics well in short study. After study in PAA has shown us that patients who are sicker at baseline that was what.
Speaker Change: With more room to improve tend to have better outcomes, particularly on the six minute walk distance into 24 week study.
Speaker Change: We saw the Centauri.
Speaker Change: Where patients with higher baseline reveal risk scores and dose with functional class III disease had a much more dramatic improvement in their six minute walk and there.
Faheem Hasnain: of PBR. It was also seen in both the Phase 2 and Phase 3 studies of Cetatarcept where Functional Class 3 patients had better outcomes than the Functional Class 2 patients. Even going back to the pivotal studies at Taiweizhou and oral imatinib and pH, the pattern holds the same. Procera was designed to enroll more of these patients to increase the study's probability of success. Our team has executed against this goal while maintaining the commercial applicability of the study's findings to a broader population of PAH patients. We believe that the baseline characteristics in ProSERA represent a population of both functional class 2 and 3 that is consistent with contemporary studies in pH, evaluating 6-minute walk at 24 weeks.
Speaker Change: P D R.
Speaker Change: It was also seen in both the phase two and phase III studies, the tighter set for functional class III patients had better outcomes than the functional class II patients even going back to the pivotal studies of <unk> and oral imatinib in P. H that pattern holds the same.
Speaker Change: <unk> was designed to enroll more of these patients to increase the study's probability of success.
Speaker Change: Our team has executed against this goal while maintaining the commercial applicability of the study's findings to a broader population of P. A H patients.
Speaker Change: We believe that the baseline characteristics and pro Sarah represent a population of both functional class II and III and is consistent with contemporary studies in ph evaluating six minute walk.
Faheem Hasnain: It's because of all this.
Speaker Change: At 24 weeks.
Faheem Hasnain: We believe that we are closer than ever to potentially providing patients with a first-in-class new treatment for PAH that addresses the underlying disease.
Speaker Change: But because of all this.
Speaker Change: We believe that we are closer than ever to potentially providing patients with a first in class new treatment for P. H that addresses the underlying disease.
Faheem Hasnain: And with that progress in mind, let's now shift our focus to the exciting prospects ahead for Sarah.
Speaker Change: How is that progress in mind, let's now shift our focus to the exciting prospects ahead for Cherilyn.
Faheem Hasnain: But before I hand it over to Richard to discuss PHILD, I want to take a quick moment to thank our partner, the QIAZ. Their partnership has enabled Saralidinib to immediately enter a global registrational phase 3 study in PHILD. This was one of the key rationale for our joint development and commercialization agreement. They are a world leader in relevant disease areas, such as respiratory, cardiometabolic and rare disease. And we feel proud and highly validated that QIESI sees the same vision for serolimbem as we do. And more than that, they are a committed partner and proponents of this trailblazing clinical development plan in PHILD.
Speaker Change: But before I hand, it over to Richard to discuss ph ILD I want to take a quick moment to thank our partner the key ASE group.
Speaker Change: Their partnership has enabled <unk> to immediately enter a global Registrational phase III study in ph ILD. This was one of the key rationale for our joint development and commercialization agreement.
Speaker Change: They are a world leader in relevant disease areas, such as respiratory cardio metabolic and rare disease, we feel crowded highly validated that key as he sees the same vision for <unk> as we do.
Speaker Change: More than that they are committed partner and proponents of this trailblazing clinical development plan in ph ILD.
Richard Aranda: And with that, I'll hand it over to Richard for discussion of PHIL-D and the Phase III Serenata Study.
Speaker Change: And with that I'll have.
Speaker Change: Is it over to Richard for a discussion of ph ILD and phase III <unk> study Richard Thank you.
Richard Aranda: Richard. Thank you. In addition to what Faheem mentioned, I am thrilled to spotlight our planned Phase 3 Serenata study in patients with pulmonary hypertension associated with interstitial lung disease, or PHILD. To remind you, PHILD is a progressive disorder characterized by the development of pulmonary hypertension in the setting of chronic and progressive lung. CHILD poses a severe burden on patients' quality of life and prognosis. The three year survival rate has been reported to be 40%, which is quite disturbing. with only one approved treatment available for PHLD in the U.S. and Limited Availability Outside of the U.S.
Richard: In addition to what he mentioned I am thrilled to spotlight our planned phase III seven honest study in patients with pulmonary hypertension associated with interstitial lung disease or ph ILD.
Richard: To remind you ph ILD as a progressive disorder characterized by the development of pulmonary hypertension in the setting of chronic and progressive lung disease.
Richard: Th ILD poses a severe burden on patients quality of life and prognosis.
Richard: <unk> three year survival rate has been reported to be 40%, which is quite dismal with only one approved treatment available for ph ILD in the U S.
Richard Aranda: There remains a substantial unmet need for effective therapy.
Richard: In limited availability outside of the U S.
Richard: There remains a substantial unmet need for effective therapies.
Richard Aranda: The Serenata study aims to fill this critical gap, offering a potentially transformative treatment option to a patient population that has long awaited effective treatment option. To this end, our development program at PHILD underscores our unwavering commitment Innovation, Excellence, and our focus on enhancing the lives of patients. developed jointly with the KJC. Serenata Study will be a global, double-blind, placebo-controlled, registrational Phase 3 trial. approximately 480 patients. will be randomized evenly to receive either 90 mg serolunum twice daily, 120 mg serolunum twice daily, or placebo. The primary endpoint is the change in 6 minute walk distance from baseline as compared to placebo at week 25.
Richard: Yeah.
Richard: The Serenata study aims to fill this critical gap offering a potentially transformative treatment option to a patient population that has long awaited effective treatment options.
Richard: So this is in our development program in ph ILD underscores our unwavering commitment.
Richard: Two innovation excellence and our focus on enhancing the lives of patients.
Richard: Developed jointly with the Crazy.
Richard: The Serenata study will be a global double blind placebo.
Richard: Trolled Registrational phase III trial.
Richard: Approximately 480 patients will.
Richard: They'll be randomized easily to receive either 90 milligram Cheryl zenith twice daily 120 milligrams twice.
<unk> twice daily or placebo.
Richard: The primary endpoint is the change in six minute walk distance from baseline as compared to placebo at week 24.
Richard Aranda: Key secondary endpoints included time to clinical worsening. and change from baseline and force vital capacity. A successful outcome on this latter key measure would provide differentiated results as compared to the currently approved treatment. We believe that in addition to targeting the pulmonary hypertension of PHILD patients, The PH, so to say, serolutinib, could also target the underlying interstitial lung disease. with preclinical data demonstrating serolunib's anti-fibrotic and anti-inflammatory attributes treatment. with Sarah Lunen could also improve lung function separately from its effect on pulmonary hypertension by targeting the underlying lung fibrosis, which is characteristic of ILD. Recent preclinical modeling has led us to believe that there is value in testing a higher dose.
Richard: Key secondary endpoints, including time to clinical worsening and change from baseline in forced vital capacity.
Richard: A successful outcome on this latter T measure would provide differentiated results as compared to the currently approved treatment.
Richard: We believe that in addition to targeting the pulmonary hypertension ph ILD patients. The P. H so to say Sarah Loopnet could also target the underlying interstitial lung disease.
Richard: Okay.
Richard: With preclinical data, demonstrating Sarah aluminum's, anti fibrotic and anti inflammatory attributes treatment.
Richard: With Sarah could also improve lung function separately from its effect on pulmonary hypertension by targeting the underlying lung fibrosis, which is characteristic.
Richard: <unk>.
Richard: Yeah.
Richard: Recent preclinical modeling has led us to believe that there is value and testing a higher dose because increasing long exposure may provide a greater improvement to the loan component of ph ILD disc.
Richard Aranda: because increasing lung exposure may provide a greater improvement to the lung component of pH biology. This potential for a dual mechanistic benefit has led us to incorporate 120 milligrams twice daily dose level of serralindu in addition to the 90 milligrams twice daily dose level in the serranata study. With the same painstaking detail with which we planned and enrolled the PROSERA study, we are diligently collaborating with our partners to identify the most suitable sites globally for this phase three trial. Considering our unique non-vasculatory mechanism, there is high investor and patient demand. But given the complexity and significance of this program, we are proceeding with thoughtful consideration.
Richard: This potential for a dual mechanistic benefit has led us to incorporate 120 milligram twice daily dose level of <unk>. In addition to the 90 milligram twice daily dose level.
Richard: The <unk> study.
Richard: With the same painstaking detail with which we planned and enrolled the <unk> study, we are diligently collaborating with our partners to identify the most suitable sites globally for this phase III trial.
Richard: Considering our unique.
Richard: Noninvasively Tory mechanism, there is high investor and patient demand, but given the complexity of significance of this program, we are proceeding with thoughtful consideration.
Richard Aranda: Further, there are no successful registrational global PHILD clinical trial precedents to follow. Therefore, we hope the Serenata study will be the first.
Richard: Part of it are no successful Reggie.
Richard: Registrational.
Richard: Global ph ILD clinical trial precedence to follow there.
Richard Aranda: We expect to begin first site activations in the fourth quarter of this year.
Richard: Before we hope to Suriname, our study will be the first.
Richard: We expect to begin first site activations in the fourth quarter of this year.
Bryan Giraudo: With this, we are extremely excited about the possibilities that this trial holds and the profound impact it could have on the lives of so Now I will hand it over to our CFO and COO, Bryan Giraudo, for a financial update. Thank you, Richard.
Richard: With this we are extremely excited about the possibilities that this trial's holds and the profound impact it could have on the lives of so many.
Brian Gerardo: Now I'll hand, it over to our CFO and C. L O Bryan <unk> for a financial update Brian. Thank.
Bryan Giraudo: We will now review the end of quarter financial results for the first quarter of 2025. We ended the quarter with $257.9 million in cash and cash equivalents and marketable securities. We continue to maintain a robust balance sheet and anticipate that our financial resources will provide sufficient capital for the first half of 2027. For the quarter ended March 31 2025 recognized revenue was 9.9 million. Our revenues associated with our collaboration with Keyes and includes $6.6 million of cost reimbursements for the quarter. R&D expenses were $38 million compared to $32.4 million for the same period in 2024.
Bryan: Thank you Richard will now review the end of quarter financial results from the first quarter of 2025, we ended the quarter with $257 $9 million of cash and cash equivalents in marketable securities. We continue to maintain a robust balance sheet anticipate that our financial resources will provide sufficient capital for the first half of 2027.
Bryan: For the quarter ended March 31, 2025 recognized revenue was $9 9 million are revenues associated with our collaboration with <unk> and includes $6 $6 million cost reimbursements for the quarter.
Bryan: R&D expenses were 38 million compared to 32 4 million for the same period in 2020 for G&A expenses for the first quarter of 2025 or $8 7 million compared to $9 6 million for the same period of 2024.
Bryan Giraudo: G&A expenses for the first quarter of 2025 were $8.7 million compared to $9.6 million for the same period in 2024.
Bryan Giraudo: The net loss for the three months ended March 31, 2025 was $36.6 million or $0.16 per share compared to a net loss of $41.9 million or $0.19 per share for the same period.
Bryan: Net loss for the three months ended March 31, 2025 was $36 6 billion or 16 cents a share compared to a net loss of $41 9 billion or 19 cents per share for the same periods in 2020.
Faheem Hasnain: Now I'll turn the call back over to Faheem for closing. Yeah, thanks, Bryan.
Bryan: Now I'll turn the call back over to closing remarks.
Faheem Hasnain: So before we take questions, I just want to remind everyone. of the Substantial Unmet Need in PAH and PHIL. These are progressive diseases with high mortality that need new, safe, and effective therapy. Due to this dire need and the historical lack of innovation, Even improved therapies with limited efficacy or poor tolerability have achieved commercial success. Patients and physicians are eagerly awaiting new therapies, particularly those with differentiated mechanisms and improved outcomes. With its potential first-in-class mechanism and growing body of evidence of the potential for reverse remodeling in this disease, paired with the safety profile observed to date, we can envision a future where serolutinib becomes a backbone therapy in pH and a multibillion-dollar franchise.
Speaker Change: Thanks, Brian so.
Speaker Change: Before we take questions.
I just want to remind everyone.
The substantial unmet need in P H in ph ILD.
Speaker Change: These are progressive disease with high mortality that need new safe and effective therapies.
Speaker Change: Due to this dire need in the historical lack of innovation.
Speaker Change: Even approved therapies with limited efficacy or poor tolerability have achieved commercial success.
Patients and physicians are eagerly awaiting new therapies are typically those <unk>.
Speaker Change: Differentiated mechanisms and improved outcomes.
Speaker Change: With its potential first in class mechanism and growing body of evidence for the potential for reverse remodeling in this disease paired with the safety profile observed to date, we can envision a future where Sarah Luton it becomes it backbone therapy in P H and a multibillion dollar franchise.
Faheem Hasnain: And this opportunity is not confined to the United States. It extends to international markets as well. Japan, which is the second largest PAH market globally after the U.S., has a number of clinical sites participating in the PROCERA study. Considering Seralindam's recent orphan drug designation and the participation of Japanese patients in ProSera, we believe that with positive results, this could support a JMDA and a subsequent approval in Japan.
Speaker Change: And this opportunity is not confined to the United States It extends to international markets as well Japan.
Speaker Change: Japan, which is the second largest P. H market globally. After the U S has a number of clinical sites participating in the <unk> study.
Speaker Change: Considering Cerro Lindo recent orphan drug designation and the participation of Japanese patients in pro Sarah We believe that with positive result, this could supported J NDA and a subsequent approval in Japan.
Faheem Hasnain: So, if there's one takeaway from today's discussion... Let it be that Gossamer is doing everything that we can to increase the chances of long-term clinical and commercial success for Sarah Lou and we're committed to maintaining the highest standards to accomplish. Our focus is not to just achieve approvable results, that's the bare minimum. Our focus is on generating comprehensive Thanks for listening.
Speaker Change: So if there's one takeaway from todays discussion.
Speaker Change: Let it be that gossamer is doing everything that we can to increase the chances of long term clinical and commercial success for salad.
And we're committed to maintaining the highest standards to accomplish this mission.
Speaker Change: Our focus is not to just and sheep approvable results that's the bare minimum.
Speaker Change: Our focus is on generating comprehensive definitive and differentiated outcomes in both of our phase III trials that will set sterile as NEP apart from other therapies on the market helped.
Unknown Executive: Operator, you may now open the line to questions. All right, ladies and gentlemen, at this time, you may press star one on your telephone keypad. If you would like to ask a question, that is star one on your telephone keypad to join the question queue.
Speaker Change: Helping lay the groundwork for our sterile lithium franchise.
Speaker Change: Operator.
Speaker Change: Now I'll open the lines for questions.
Speaker Change: All right, ladies and gentlemen at this time you May press Star one on your telephone keypad. If you would like to ask a question that is star one on your telephone keypad to join the question queue.
Joe Schwartz: And first up, we have Joe Schwartz of LeerRain. Great. Thanks so much for taking my questions. I have two.
Speaker Change: And first up we have Joe Schwartz of Leerink.
Joe Schwartz: First, with 343 patients enrolled in Procera to date, have you considered stopping enrollment there in order to be... still report data this year. Could you give us some insight into your calculus here and why you've decided to enroll these last patients and push the data into 26? And then I have a follow up.
Speaker Change: Okay.
Speaker Change: Great. Thanks, so much for taking my questions I have two.
Speaker Change: First with 343 patients enrolled in <unk> to date have you considered stopping enrollment there in order to be able to still report data. This year could you give us some insight into your calculus here and why you've decided to remove these last patients had pushed the data.
Faheem Hasnain: Yeah, thanks, Joe. Thanks for your question. It really relates to the fact that there's been such incredible demand to study, Joe. And obviously, as we started to signal that we were nearing the end of enrollment, that demand got even bigger. And it's really important that we honor the commitment we have to patients and to their physicians to ensure that we have worked alongside of all of these physicians and continue to do so into the future. Not only with Sarah Lindner, but also with the PHILD Phase 3, which many of these physicians will also be investigators in.
Speaker Change: 26, and then I have a follow up.
Speaker Change: Yeah. Thanks, Joe Thanks for your question.
Speaker Change: It really relates to the fact that there's been such an incredible demand study Joe.
Speaker Change: And.
Speaker Change: Obviously as we started to signal that we were nearing the end of enrollments that demand got even bigger.
Speaker Change: And it's really important that we honored the commitment we have to patients and to their physicians to ensure that we have worked alongside all of these positions and continue to do so into the future not only with Cheryl isn't it but also with the ph ILD phase III, which many of these physicians.
Faheem Hasnain: And so we wanted to honor that commitment and decided to honor and we closed off screening. So we will no longer be screening patients, but there is a bolus, a large bolus of patients that are in the screening funnel now. And our commitment was to follow through, determine which of those patients would qualify for the study. And then if they qualify, enroll them. So that should take us into somewhere around the June timeframe. And just as we think about the timing for that, first and foremost, we care about the quality of the study. First and foremost, we care about bringing the right patients into the study and timelines, of course, are important.
Speaker Change: We'll also be investigators in and so we wanted to honor that commitment and decided to honor and we closed off screening. So we will no longer be screening patients, but there is a bolus a large bolus of patients that.
Speaker Change: Our inch in the screening funnel now and our commitment was to follow through determined which of those patients would qualify for the study and then if they qualify enroll them so that should take us into somewhere around the June timeframe and just as we think about the timing that.
Speaker Change: First and foremost we care about quality of the study first and foremost we care about bringing the right patients in the study.
Joe Schwartz: So we will conclude the study, last patient out will certainly be in the fourth quarter, near the end of the fourth quarter. By the time we scrub, analyze, collect the data, scrub the data, analyze the data, and get it ready for a top-notch presentation. That will take a little bit of time. That's the February date. Very helpful, thanks.
Speaker Change: Unlicensed course important so we will conclude the study last patient out will certainly be in the fourth quarters.
Speaker Change: Fourth quarter.
Speaker Change: Time will describe <unk>.
Speaker Change: Scrubbed the data analyzing the data and get it ready for.
Speaker Change: That will take a look at.
Andreas Argeryse: And then, could we delve some more into baseline characteristics in ProSera?
Speaker Change: <unk>.
Speaker Change: Okay.
Speaker Change: Very helpful. Thanks, and then could we tell some warrants a baseline characteristics and pro Sarah.
Faheem Hasnain: Since the TORI trial enrolled patients primarily from North America, whereas ProSera will be more global, I was wondering if we could get your thoughts on how this factor could influence the results. Yeah, Torrey, we have sites also globally, but not as extensively as we have with Procera. So Procera has a much broader global footprint in the context of the sites that we've enrolled. As an example, there is a significant portion of patients that will come out of places like Latin America, South America, Eastern European countries, and Asia-Pacific. And the reason I highlight that is it's really interesting, because what we find in those jurisdictions are really excellent patients for us to enroll in this study.
Speaker Change: Since the Tory trial enrolled patients primarily from North America, whereas <unk> will be more global I was wondering if we could get your thoughts on how this factor could influence the results.
Speaker Change: Yeah, I'm, sorry, we have sites.
Speaker Change: Also globally, but not as extensively as we have with pro Sarah So coursera has a much broader global footprint in the context of the sites that we've enrolled.
Speaker Change: Yes.
Speaker Change: As an example, there is a significant portion of patients that will come out of places like Latin America South America.
Speaker Change: Eastern European countries.
Speaker Change: In Asia Pacific and the reason I highlight that is it's really interesting because what we find in those jurisdictions are really excellent patient.
Richard Aranda: And by that, I mean less comorbidities and patients that in historical trials from those regions have shown a much larger magnitude of effect on their six-minute walk. So as an example, the Celler study for cetatorsept, the patients that they enrolled in South America saw somewhere in the versus the U.S. patients in that study were around 26 meters. And that's largely, we believe, because these patients are just more pure PAH patients with less comorbidity and an easier opportunity to show that magnitude of effect. Richard, I don't know if you have anything else you want to add to that?
Speaker Change: Excellent patients for us to enroll into the study and by that I mean.
Speaker Change: Less co morbidities and patients that in historical trials from those regions have shown a much larger magnitude of effect on their six minute walk so as an example.
The stellar studies for so tatter set the patients that they enrolled in South America saw somewhere in the neighborhood of mid 70 meter improvement in walk versus the U S. Patients in that study were around 26 meters and that's largely we believe because these patients are just more pure ph patients with less co morbid.
Speaker Change: And an easier opportunity to show that magnitude of effect.
Bryan Giraudo: No. No, Faheem, I think that's exactly right. You know, the younger patients, the... different treatment regimens also contribute. those patients that you've outlined. Yeah, Bryan? And Joe, I'd also just remind you that part of the reason why we had a disproportionately large number of patients from North America, the United States, and Torrey was because many of our ex-U.S. sites were closed because of the COVID-19 pandemic, and those physicians were not actively doing clinical research.
Speaker Change: Richard I don't know if you have anything else you want to add to that no no for him I think that's.
Speaker Change: Exactly right.
Speaker Change: The younger patients.
Speaker Change: Different treatment regimens also contributed to.
Speaker Change: Those patients that you've outlined and Brian and Joe I'd also just.
Speaker Change: Mind, you that part of the reason why we had a disproportionately large number of patients from.
Speaker Change: North America, the United States, and Tory wasn't because many of our ex U S sites were closed because of the COVID-19 pandemic and those physicians were not actively doing clinical research. So we do believe the combination of operating in a normal time and in a broader global.
Unknown Executive: So we do believe the combination of operating in a normal time and in a broader global reach is going to give us a ridiculous amount of space and population. Thanks for the call.
Speaker Change: <unk> global reach is going to give us contiguous.
Speaker Change: For this patient population.
Andreas Argeryse: Alright, next up we have Andreas Argeryse of Oppenheimer. Your line is now open. Great. Thanks for taking our questions, and congrats on all the progress on your completion of enrollment. And also, Faheem, thanks for the comparisons of the various baseline characteristics with Feller. You preempted one of my questions, but very helpful. So we only have a couple here. We'll keep it short as we can.
Speaker Change: Thanks for the color.
Speaker Change: Thanks, Joe.
Andreas Argo: All right next up we have Andreas Argo rise of Oppenheimer. Your line is now open.
Speaker Change: Alright, thanks for taking our questions and congrats on all the progress and completion of enrollment.
Speaker Change: Thanks for the comparisons are very baseline characteristics seller.
Speaker Change: One of my questions, but very helpful.
Andreas Argeryse: The baseline in Coursera now in hand, have powering assumptions changed at all? And then were stringent enrollment criteria the reason that the enrollment took a little longer than previously expected? And then last, when it comes to safety, Sarah Lutnett has a clean profile to date. How do you think these upcoming results can address the generalized concern that TTIs have off-target effects and Sarah Lutnett doesn't? Thanks.
Speaker Change: Only have a couple here, we'll keep it short with baseline and Coursera now in hand, our powering assumptions changed at all and then we're stringent enrollment criteria. The reason that the woman took a little longer than previously expected and then lastly, when it comes to safety.
Speaker Change: Sarah Luna has a clean profile to date.
Speaker Change: How do you think upcoming results kind of breath of generalized concern.
Faheem Hasnain: Yeah, so I'll take a portion of that question and have Richard, as well, jump in. Anybody else on the team? Certainly, as it relates to the baseline characteristics that you've seen, I think your question, Andreas, was really kind of, does that kind of lend, does the focus on those baseline characteristics and the stringent entry criteria lend to kind of the time that it took to enroll a study? I would say unequivocally, yes. As an example, and just kind of further highlight that point, Andreas, we screened somewhere in the neighborhood of 750 patients in this study, which is a significant number of patients.
Speaker Change: There's some off target effect.
Speaker Change: Thanks.
Speaker Change: Yeah. So I'll take a portion of that question then have Richard as well jump in anybody else on the team.
Speaker Change: Certainly as it relates to the baseline characteristics that you've seen I think your question Andreas was really kind of does that kind of lend does it focused on those baseline characteristics and the stringent entry criteria lend to kind of the.
Speaker Change: The time that it took to enroll the study.
Speaker Change: I would say unequivocally yes.
Speaker Change: As an example, and just kind of further highlight that point addressed we had.
Speaker Change: We screened somewhere in the neighborhood of 750 patients.
Bryan Giraudo: And the fact that that's about, you know, double what we have actually will end up enrolling, that should tell you two things. One, that we've been incredibly stringent to our entry criteria into this study for all the reasons that we've talked about. We think we, given this criteria that we put into place and now have been able to achieve, we think that really enhances our probability of success. And I think the second thing that that says in terms of number of screen screening opportunities that we've had is the significant demand for the study. That's a significant number of patients, and there was a tremendous amount of demand from physicians, the treaters, to be able to have their patients evaluated for their entry into the study.
Speaker Change: A significant number of patients.
Speaker Change: And the fact that.
Speaker Change: That's about double what we have actually will end up enrolling that should tell you two things one that we've been.
Speaker Change: Stringent to our entry criteria into the study for all the reasons that we've talked about we think we given this criteria that we put into place and now have been able to achieve we think that really enhances our probability of success and I think the second thing that that.
Speaker Change: Says in terms of the number of screen.
Speaker Change: Screening opportunities that we've had is the significant demand for this study that's.
Speaker Change: That's a significant number of patients and there was a tremendous amount of demand from physicians in treating physicians the treaters to be able to have their patients evaluated for their entry into the study and I think that's you know.
Richard Aranda: And I think that's, you know, a vote of confidence, if you will, from the physician community about the promise of seroludin.
Speaker Change: A vote of confidence if you will from the physician community about the promise of Sarah Loopnet.
Bryan Giraudo: Yeah, Richard, I think one of your first questions around does the baseline characteristics impact the power of the study and the answer. know directly from a technical standpoint that we have over 90% power given the sample size. In fact, just to reiterate what Faheem mentioned, the study intentionally was designed to enroll this population in anticipation of the treatment effect that we would observe, which is complementary to the sample size and the expected power, but based on that treatment effect and standard deviation, we're basically right on target. I think, Andres, your last question was around safety, and certainly, to date, we remain very, very pleased with the safety profile we have seen.
Speaker Change: Yes, Richard I think.
Speaker Change: One of your first questions around does the baseline characteristics impact the power of the study and the answer is.
Speaker Change: No.
Speaker Change: From a technical standpoint.
Speaker Change: We have over 90% power given the sample size in fact.
Speaker Change: Just to reiterate what <unk> mentioned the study intentionally was designed to enroll this population so.
Speaker Change: In anticipation of the treatment effect that we would observe.
Speaker Change: Which.
Speaker Change: It is complementary to the sample size and the expected power, but based on that treatment effect and standard deviation.
Speaker Change: We're basically right on target.
Speaker Change: Okay.
Speaker Change: I think I'll address your last question was.
Speaker Change: Around safety and certainly to date, we remain very very pleased with the <unk>.
Richard Aranda: Again, that is a function of both design of the molecule, the route of administration, as well as the fact that we designed everything to be on target, which we think, again, as Bob has spoken many times about, long-term, in addition to what we think will be robust efficacy, our safety profile and ease of use will be a competitive advantage.
Speaker Change: Safety profile, we have seen.
Speaker Change: Again that is a function of both design of the molecule. The route of administration as well as the fact that we designed everything to be on target.
Speaker Change: We think again.
Speaker Change: As Bob has spoken many times about long term. In addition to what we think will be robust efficacy or safety profile and ease of use will be a competitive advantage, yeah and Andreas if I can just add just to what Brian said just for one last comment here.
Richard Aranda: Yeah, and Andres, if I could just add just to what Bryan said, just for one last comment here. That safety profile, combined with the efficacy that we expect to see, certainly the efficacy that we saw in functional class III and higher-risk patients in TORI, and the open-label extension experience that showed that we continue to see improvement over time, possibly related to the effect, the reverse remodeling effect that we hypothesize is going on, that really positions us well commercially to be used across not only a broad swath of PAH patients, but also to... suggest that there's an opportunity for positioning this drug as the backbone of therapy for earlier use to prevent longer-term progression.
Speaker Change: That safety profile combined with the efficacy that we expect to see certainly the efficacy that we saw in functional class III and the higher risk patients and in Torrey and the open label extension experience that show that we continue to see improvement over time.
Speaker Change: Possibly related to the the effect the reverse remodeling in fact that we hypothesize just going on that really positions us well commercially to be used across not only a broad swath of P. A H patients but also to.
Speaker Change: Suggest that there's an opportunity for positioning this drug as the backbone of therapy for earlier used to prevent longer term progression as we all know this is a progressive disease, where every patient progresses and if we can delay hubs.
Richard Aranda: As we all know, this is a progressive disease where every patient progresses, and if we can delay, halt that progression, that's an incredibly meaningful outcome for patients.
Andreas Argeryse: Fantastic, appreciate the call, congrats on all the progress.
Speaker Change: That progression, that's an incredibly meaningful outcome for patients.
Speaker Change: I appreciate the call congrats on all the progress.
Yasmin Rahimi: All right, next up we have Yasmin Rahimi of Piper Sandler. Good afternoon, team. Really excited for you. Congrats on so many milestones, right? Enrollment completion, unveiling the baseline, and the PHILD to kicking that all off. Really incredible progress and updates today.
Speaker Change: Yes. Thank you.
Speaker Change: Yeah.
Speaker Change: All right next up we have Yasmin rahimi of Piper Sandler.
Yasmin Rahimi: Good afternoon team really excited for you congrats on so many milestones right enrollment completion unveiling the baseline and the ph ILD is kicking that off really incredible progress and updates.
Yasmin Rahimi: A few questions, three for you. I guess the first question, team, is for the baseline measures, are you, did you look at baseline PBR in the PROSERA study? Question one. Question two is, once the study finishes fully enrollment, are you planning to give us another cut of the baseline and maybe a little bit additional information? I don't know if there's going to be another disclosure around it before we get the data in February. And then the third one is, given that the endpoints for both of these, between the PHILD and the PH study or the six med walk test, is there anything we can infer from read through from PROSERA to Sarnata now that we have the study design?
Yasmin Rahimi: A few questions for you I guess the first question is for the baseline measures are you did you look baseline PBR in that <unk> study.
Yasmin Rahimi: Question. One question two is when is the study finishes fully enrollment are you planning to do.
Yasmin Rahimi: Give us another cut of the baseline and maybe a little bit.
Yasmin Rahimi: <unk> I don't know if that's going to be another disclosure around that before we got the data in February.
Yasmin Rahimi: And then the third one is given that the end points of both of these pop between the ph ILD and ph study or the six minute walk test is there anything we can infer from wheat through problem per se right.
Yasmin Rahimi: Appreciate if you could take those three questions.
Yasmin Rahimi: Now that we have the study design I appreciate if you could take the great. That's.
Faheem Hasnain: Thanks for your question, Yasmeen. As it relates to the question around further updates, I think as it relates to the baseline, we've given you baseline data on 323 patients. We don't expect that to materially change given just the number of patients that we've been able to evaluate baselines on. And I think we can be pretty clear with you that we will complete enrollment by latest mid-June. And so, there won't be any mystery there. Just we know that now with great certainty given that we know exactly how many patients are in the funnel. So, I think there should be no uncertainty as to when our last patient in will be.
Yasmin Rahimi: Great questions.
Speaker Change: Thanks for your question has made as it relates to the question around further updates.
Speaker Change: I think as it relates to the baseline we give new baseline data on 323 patients are we don't expect that to materially change given just the number of patients that we've been able to evaluate baselines on.
Speaker Change: And I think we can be pretty clear with you that we will.
Speaker Change: Clean enrolment by latest mid June.
Speaker Change: So.
Speaker Change: There won't be any mystery there just we know that now with great certainty given that we know exactly how many patients are in the funnel.
Faheem Hasnain: As I said, it'll be by mid-June. And I think it's fair to conclude that the baseline that we've given you will be very close to the baseline that we'll end up with in the study.
Speaker Change: So I think there should be no uncertainty as to when our last patient in will be as I said it'll be by mid June and I think it's fair to conclude that the baseline that we've given you will be very close to the baseline net will end up with a new study Richard Yeah too.
Richard Aranda: Richard? Yeah, to Yasmeen, answer your question about the PVR. We did have a PVR entry criteria of 400 or greater. We did not mandate to have a PVR as an endpoint. So, we won't have that in this particular study. But yes, we did have minimal criteria for a PVR. And that could have been based on some historic data or at the time of screening. And It's in line to what you would expect, given the requirement that we had. In terms of your question around read-through, Of course, assuming that Pocera is positive, that portends the possibility that the PHILD would also be positive.
Richard: Yes, Ben answer your question about the PBR.
Richard: We did have a PCR entry criteria of 400 or greater.
Richard: We did not mandate to have <unk> as an endpoint. So we won't have that in this particular study, but yes, we did have minimal criteria.
Richard: PBR and that could have been based on some historic data or at the time of screening.
Richard: And.
Richard: It's in line to what you would expect given the requirement that we had.
Richard: In terms of your question around reads read through.
Richard: Oh of course.
Richard: Assuming that Sarah is positive that portends.
Richard Aranda: Having said that, we also know that PHILD patients are going to have lower six-minute walks than in Group 1 patients. They're actually sicker overall. And so, under the thesis that... You know, in Procera, we've have an enriched population of greater severity, I think just implicit in studying the group 3 population, those patients are sicker. So if the drug is effective in that population, we should also see a very good treatment effect on six minute block, as well as other parameters such. And so I think that definitely does increase the probability of success, and there would be a read-through.
The.
Richard: <unk> that the ph ILD would also be positive having said that we also know that ph ILD patients who are going to have lower six minute walks then it grew one patients theyre actually sicker.
Richard: Overall, and so under the thesis that.
Richard: Sure.
Richard: <unk>.
Have an enriched population of greater severity I think just implicit and studying the group three population those patients are sicker. So if the drug is effective in that population. We should also see a very good treatment effect on six minute walk as well as other parameters such as empty pro BNP.
Richard: Cetera.
Richard Aranda: But I think the other dimension here that's exciting about the PHILD population and the opportunity for serolutinib is that, certainly preclinically, we've been able to determine that serolutinib also has some antifibrotic properties, infecting really important markers of fibrosis. And as you think about this next patient population, those with interstitial lung disease, that could be a significant added benefit to the treatment of those patients.
Richard: And so I think that definitely does increase the probability of success and there would be a read through.
Richard: The other dimension here, that's exciting about the ph ILD population and and the opportunity for <unk>.
Richard: Certainly pre clinically we have been able to determine that several of them that also has some anti fibrotic properties and affecting really important.
Richard: Markers of fibrosis and as you think about this next patient population does with interstitial lung disease that can be a significant added benefit to the treatment of those patients.
Yasmin Rahimi: Excellent. Thank you so much, team.
Yasmin Rahimi: Really excited for you. And I'll jump back in the queue. Thank you.
Speaker Change: Excellent. Thank you so much team really excited.
Paul Choi: All right, next up we have Paul Choi of Goldman Sachs. Hi, everyone. Good afternoon, and thank you for taking our questions. Congratulations on all the progress.
Speaker Change: I'll jump back into queue.
Speaker Change: Thank you you asked me.
Paul Choi: Alright next definitely a Paul Choi of Goldman Sachs.
Paul Choi: I want to return to baseline characteristics for a moment, and can you share or do you plan to share with the final baseline just what baseline sotetracept usage is, given that it's been available both in the U.S. and ex-U.S. for a few quarters now?
Paul Choi: Hi, everyone. Good afternoon, and thank you for taking our questions. Congratulations on all the progress.
Speaker Change: I want to return to baseline characteristics for a moment and can you share or do you.
Paul Choi: Plan to share with the final baseline.
Paul Choi: What baseline so 10 or stop usage is.
Paul Choi: And then in terms of a clinical impact from that, can you maybe just comment on how you're thinking of what is considered clinically meaningful now in terms of six-minute walk, given that it has been available commercially? Has there been any evolution and change of thought among the KOL community on six-minute walk here, given sotetracept has been on the market for a few quarters?
Paul Choi: Given that it's been available both in the U S and ex U S for a few quarters now.
Paul Choi: And then in terms of our clinical impact from that can you maybe just comment on how youre thinking of what is considered clinically meaningful now in terms of six minute walk.
Paul Choi: Given that it has been available commercially has there been any evolution and change of thought among the Kols community on six minute walk here given some tighter stuff that's been on the market for a few quarters.
Paul Choi: And then one for Bryan is can you just remind us, you know, what TAZ-related milestones are sort of baked into your cash runway guidance? Is there anything else that we should be factoring in, just sort of what the pushes and pulls are that could potentially extend your cash runway? Thank you for taking our questions.
Paul Choi: And then one for Brian.
Speaker Change: Can you just remind us what Casey related milestones are sort of baked into your cash runway guidance is there anything else that we should be factoring in just sort of what the pushes and pulls are that could potentially extend your cash runway. Thank you for taking our questions.
Bryan Giraudo: Sure, Paul. I'll start with the first one around backgrounds to TATRCEPT. As you recall, we had expectations that we would probably have about 10% of the study or roughly 35 patients on backgrounds to TATRCEPT. Recall, if you were on backgrounds to TATRCEPT, there were two important components to that. You had to meet our entry criteria, which would suggest that TATRCEPT wasn't working for you, or, and you would have to have been on stable TATRCEPT dosing for six months. I think we were very surprised on how few patients were on stable backgrounds to TATRCEPT dosing.
Paul Choi: Sure Paul I'll start with the first one around background scatter steps as you recall, we had expectations that we would probably have about 10%.
Paul Choi: The study of roughly 35 patients on background tighter ship recall, if you were on background chatter scepter were two important.
Paul Choi: Components to that you had to meet our entry criteria, which would suggest the tower. So it wasn't working for you or and you would have to would have been on stable <unk> dosing for six months I think we were very surprised on how few patients were on stable.
Paul Choi: Backgrounds to tighter dosing so will be cut.
Paul Choi: A couple of dozen inquiries, we had about patients coming in to date I think we've enrolled three or four patients on background salaries up which we think again speaks to the real world experience of CIT downturns have been.
Bryan Giraudo: Yeah, so Paul, it's a really interesting question that you've asked and one that I think is really important, the clinically meaningful effect for six-minute walk. So I guess I'll start off by saying serolubin appears to be differentiated from any other PAH treatment thus far that we've seen in that we see continued improvement over time as evidenced by our open label extension data where patients, even the less sick patients in TORI that didn't have as profound a result saw improvement out to week 72. and certainly even those patients with a more profound improvement, the more sick patients also saw improvement and that is a fairly unprecedented result.
Paul Choi: Not as linear as we were expecting in regards to clinical effect I'll turn it over to Jim.
Jim: Yeah, So Paul.
Speaker Change: So a really interesting question that you've asked and one that I think is really important the clinically meaningful effect for six minute walk.
Speaker Change: So I guess I'll start off by saying Sarah.
Speaker Change: Appears to be differentiated from any other P. H treatment, thus far that we've seen in that we see continued improvement over time.
Speaker Change: As evidenced by our open label extension data, where patients even though even the less sick patients in Torrey that didn't have as Profounder result.
Speaker Change: Saw improvement out to week 72.
Speaker Change: And certainly even those patients with a more profound improvement the more sick patients.
Speaker Change: Also saw an improvement and that is fairly in a fairly unprecedented result.
Bryan Giraudo: Assuming that we continue to see that trend in the open-label extension portion of the ProSera study, what I believe that the treating community is thinking about is that the week 24 data will just be a point in time to which then they can expect patients to improve beyond that. And so that really starts to then ask and play into the question that you've asked is what is a clinically meaningful effect for ProSera? And certainly in the dialogue that we've had with our experts, our key opinion leaders, our steering committee, I would say that anything in the 20-meter-plus improvement in six-minute walk becomes a very clinically meaningful effect given the safety profile of the drug, the opportunity to use it earlier in line of therapy to try to prevent longer-term progression, and the promise of improvement over time.
Speaker Change: Assuming that we continue to see that trend in the open label extension portion of the <unk> study.
Speaker Change: What I believe that the treating community is thinking about is that the week 24 data will just be a point in time too, which then they can expect patients to improve beyond that and so that really starts to then ask and play into the question that you've asked is what is a clinically meaningful.
Speaker Change: Will affect <unk> Sara.
Speaker Change: And certainly in the dialogue that we've had with our experts are key opinion leaders, our steering committee I would say that.
Speaker Change: Anything in the in the 20 meter plus improvement in six minute walk becomes a very clinically meaningful effect given the.
Speaker Change: The safety profile of the drug the opportunity to use it earlier in line of therapy to try to prevent longer term progression and the promise of improvement over time.
Bryan Giraudo: Again, that's unprecedented, not been seen in this environment. So I think it's erroneous to actually just say cetatorcept was at X and therefore you need to be at X or Y, because the basic point is this. Every one of these patients will progress, cetatorcept will see really profound effects in a subset of patients, somewhere in the neighborhood of 30% is what we've seen from the trials, which leaves a large swath of patients with significant unmet need. And certainly there will still be patients who experience intolerable side effects with cetatorcept, and we're seeing that continuing to build in the real-world database.
Speaker Change: That's unprecedented.
Speaker Change: Not been seen in this environment so.
Speaker Change: I think it's erroneous to actually just say said Patterson was at X and therefore, you need to be at X or y.
Speaker Change: Because the basic point is this every one of these patients have progressed. So tighter set we'll see really profound effects in a subset of patients somewhere in the neighborhood of 30% to what we've seen from the trials, which leaves a large swath of patients with significant unmet need and certainly there will.
Speaker Change: I'll still be patients who experience.
Richard Aranda: And we will see patients who wane in their effect with cetatorcept and are also left with a need. So by the time we get to market, there is going to be a large portion of patients that really need something, and the promise of a drug like this that has the potential to show reverse remodeling effects can be pretty profound.
Speaker Change: On tolerable side effects with Santander Scepter, and we're seeing that continuing to build in the real World database, and we will see patients who Wayne and their effect with <unk> and are also left with a need so by the time, we get to market. There is going to be a large portion of patients that really need something in the promise of <unk>.
Richard Aranda: Richard? Just to add, I think it's also important that the treatment effect needs to be interpreted without the context of the influence of hemoglobin. probably influenced the response that was observed with Siltaterson, for example. plus the population that we've been talking about is a much more sicker population. overall. So I think those are some additional considerations.
Speaker Change: A drug like this that has the potential to show reverse remodeling effects can be pretty profound so Richard just to add I think it's also important that.
Speaker Change: The treatment effect needs to be interpreted.
Speaker Change: Without the context of the influence of hemoglobin.
Speaker Change: <unk>.
Speaker Change: Probably influenced the response that was observed with Patterson for example, plus the population that we're still guys. We've been talking about is a much more sicker population.
Bryan Giraudo: Bob, do you want to add anything? Okay, thanks. I think, Paul, to your question on Chiesi milestones, our cash runway does not have any of the big milestones that we would expect on regulatory and sales milestones. I think the biggest influence on our financials with the Chiesi relationship is the cost sharing, and we expect that cost sharing to meaningfully increase as we bring the costs in from the Procero study and kick off the Serenata study, or we'll be cost sharing on a 50-50 basis. Great. Thank you very much. Thanks, Paul.
Speaker Change: Overall, so I think those are some additional considerations Bob do you want to add.
Speaker Change: Okay, Thanks, and I think part of your question.
Speaker Change: Crazy milestones our cash runway does not have any of those big milestones that we would expect on a regulatory and sales milestones I think the biggest influence on our financials with the Qs relationship is the cost sharing and we expect that cost sharing to meaningfully increase as we bring the cost in front of the <unk>.
Speaker Change: <unk> studied and kick off the Sirona study or will be cost sharing on a 50 50 basis.
Olivia Brayer: All right, next up we have Olivia Brayer of Kantor. Hey, good afternoon, guys, and thank you for the question and congrats on all the progress you've been making this year. Can you disclose what treatment effect you're targeting as it relates to your powering assumptions? And then as you think about the regulatory bar for success, do you know whether FDA is looking for a certain threshold on six minute walk improvement, both with respect to key value, but also meter improvement? And then just maybe in terms of timing of the disclosure, does that include a safety closeout period or was anything else added to that protocol that's maybe changing the time of those data?
Speaker Change: Yeah.
Speaker Change: Great. Thank you very much.
Speaker Change: Thanks, Paul.
Speaker Change: Alright next definitely have Olivia brayer can tour.
Speaker Change: Hey, good afternoon, guys and thank you for the question and congrats on all the progress you've been making this year can.
Speaker Change: Can you disclose what treatment effect, you're targeting as it relates to your powering assumptions and then as you think about the regulatory bar for success do you know what the FDA is looking for a certain thresholds on six minute walk improvement both with with respect to P value, but also meter improvement.
Speaker Change: And then just maybe in terms of timing of the disclosure does that include a safety close out period or was anything else added to that protocol that that's maybe changing the time of those data.
Olivia Brayer: So, to answer your question about the powering, the initial powering, which is the same, is based on a 30-meter treatment effect on a 6-minute walk with a standard deviation of 70, which gives us greater than 90% power. That hasn't changed. The other question was around, yeah, the Time of the data readout does include the safety follow-up, and that also hasn't changed. Let me, did we, let me, did we capture all your questions there? Yeah, I think you had regulatory guidance as well. Maybe just to follow up on that safety closeout period, was, was anything added to the protocol that's actually maybe shifted, you know, timing of the data readout?
Speaker Change: So.
Speaker Change: To answer your question about the powering the initial borrowing which is the same as based on a 30 meter treatment effect on six minute walk with a standard deviation of 70, which gives us greater than 90% power, but that hasnt changed.
Speaker Change: And.
The other question was around.
Speaker Change: Yeah.
Speaker Change: Time will the data readout does include that the safety follow up and that also hasnt changed.
Speaker Change: Did we lose it.
Speaker Change: Did we capture all your questions there.
Anne: Thank you Anne.
So our guidance as well maybe just a follow up on that safety closed out period, what was anything added to the protocol that's actually maybe shifted.
Karen Peterson: No. And then the other question, Faheem, was just on the regulatory bar and how the FDA is thinking about six-minute walk improvement. Have they said anything in terms of what p-value or an actual meter improvement that they're looking to see for approval?
Anne: Timing of the data read out okay, no and no.
Anne: And then the other question. So he was just on the regulatory bar and how the FDA is thinking about six minute walk improvement have they said anything in terms of what P value or an actual meter improvement that theyre looking to see for approval.
Karen Peterson: I'll turn that question over to Karen Peterson, our Head of Regulatory. Yeah, so we had this discussion with the FDA when we designed the protocol as well as EMA. They agreed to both the powering and how it was powered in terms of the distance in the magnitude of the fact that we were looking for. Okay, great. Helpful. Thank you.
Speaker Change: I'll turn that question over to Karen Peterson, our head of regulatory yeah. So we have this discussion with the FDA. When we designed the protocol as well as the MAA. They agreed the powering and how it was powered in terms of the distance in the magnitude of the fact that we were looking for.
Anne: Okay.
Patrick Tuccio: All right, next up we have Patrick Tuccio of HC Wainwright. Thanks. Good afternoon. I have a few questions on PAH. The first is just a baseline. Do we know the number of patients who discontinued Sotatercept previously? And then separately, you presented open label extension data that shows continued PVR and six-minute walk distance benefit. What read-through from this data do you see to Procera, if any? And separately, what are the commercial implications of that OLE data?
Speaker Change: Okay. Okay helpful. Thank you guys.
Anne: Thank you.
Speaker Change: Alright next up we have Patrick <unk> of H C Wainwright.
Speaker Change: Thanks, Good afternoon, I have a few questions on <unk>. The first is Jeff.
Speaker Change: Baseline do we know the number of patients who discontinued so tighter Scott.
Speaker Change: Previously and then separately.
Speaker Change: Presented open label extension data that shows continued PBR and six minute walk distance benefit what read through from this data do you see to per Sarah if any and separately what are the commercial implications of that data.
Bryan Giraudo: And then a few on PHILD. The first is just the doses, you know, the rationale behind the doses selected for this study. And then separately, it was mentioned, you know, the data could demonstrate serolutinib is having a beneficial impact on underlying interstitial lung disease. What data or, you know, if you're able to demonstrate this benefit, what are the implications for the product profile? What data should we be looking for to show that potential? And what are the implications, then, for the potential addressable patient population? Thanks, Patrick. I'll take the first one as far as patients who discontinued cetatorsept.
Speaker Change: And then a few on ph ILD. The first is just the doses.
Speaker Change: The rationale behind the doses selected for the study and then separately. It was mentioned the data could demonstrate.
Speaker Change: Having a beneficial impact on underlying interstitial lung diseases, what data or if you are able to demonstrate this benefit what are the implications for the product profile what data should we be looking for to show that potential and what are the implications for the potential addressable patient population.
Bob Smith: Due to the long half-life of cetatorsept and our requirement that you need to have a five half-life washout before you can come in, we had very few cetatorsept discontinuations in the study. Memory serves me correct. I think it was high single digits to date. Rich, I'll turn it over to you for the other part. Patrick, what was the second part to your question? Yeah, so the second part on PAH was just around the open label extension data, the read-through from that data, if any, to Procera, and as well, just sort of commercial implications of that OLE data.
Patrick: Thanks, Patrick I'll take the first one as far as.
Speaker Change: Patients who discontinued.
Speaker Change: Understood.
Speaker Change: Due to the <unk>.
Speaker Change: A long half life of <unk> with a requirement that you need to have.
Speaker Change: Page five a housewife washout, where you could come in we add very few Santander <unk> discontinuation in the study if memory serves me correct I think it was high single digits.
Speaker Change: Dave.
Speaker Change: Yes.
Speaker Change: Rich I'll turn it over to the other part.
Speaker Change: Could you just remind me what the other.
Patrick: Patrick what was the second part of your question yes.
Patrick: The second part on PAA is just around the open label extension data read through from that data to <unk> as well just sort of commercial implications of that OLED data.
Bob Smith: Yeah, I'll ask Bob Smith, our Chief Commercial Officer, to touch on that one. Yeah, I think there's a very positive read-through there. As we have taken the OLE data out into the community, the KOL community, we've just had really impressive feedback, and we saw, as well, that being a key lever for the increased enrollment in Procera when they started to realize the benefit over time, which, as Faheem mentioned, is unique to Saralutinib. Yeah, I think the open label extension implications on commercial are kind of what I've already mentioned, Patrick, which is if that data is replicated as we hope it will be in the context of the Procera study.
Speaker Change: Yeah, I'll ask Bob Smith, our Chief commercial officer to touch on that Yeah, I think theres, a very positive read through there.
Patrick: As we have taken.
Patrick: The early data out into the community to Kols community.
Patrick: We've just had really impressive feedback and when we saw as well that being a key lever.
Patrick: The increased enrollment in coursera when they started to realize the benefit overtime, which has been mentioned is as unique to to sell loopnet and.
Patrick: Okay.
Patrick: Yes.
Speaker Change: Yeah, I think the open label extension implications on commercial or kind of what I.
Patrick: Already mentioned, Patrick which is is.
Bob Smith: I mean it is, and we've had this feedback from the community. That, as I said, it was largely unprecedented. Most studies you see, and would expect to see, just a plateauing of effect. So it really has an impact on positioning of the drug in the marketplace, and that is like other progressive disease. We see the desire and the hope to be able to use these drugs earlier, assuming that they've got the right safety profile, because if you're using a drug earlier in the line of therapy, quality of life matters. and matters because they're going to be on treatment for a long period of time, longer duration of treatment, and they're being treated in the earlier stage of their disease, which means they're otherwise living a reasonably normal life.
Speaker Change: If that data is replicated as we hope it will be in the context of the pro Sarah study.
Speaker Change: It is and we've had this feedback from the community.
Speaker Change: As I said it is largely unprecedented.
Speaker Change: Most studies, you see and would expect to see just a plateauing of the factory.
Speaker Change: And so it really has an impact on positioning of the drug in the marketplace.
Speaker Change: And that is like other progressive diseases.
Speaker Change: We see the desire and hope to be able to use these drugs earlier, assuming that they've got the right safety profile, because if you're using a drug the earlier in the lion therapy quality of life matters.
Speaker Change: And matters and because theyre going to be on treatment for a long period of time longer duration of treatment and they're being treated in the earlier stage of their disease, which means they are otherwise living a reasonably normal life, so safety really matters and if theres a promise there a potential to actually remodel.
Bob Smith: So safety really matters. And if there's a promise there or a potential to actually remodel both lung and heart, as we've seen by our imaging data and our echo data, that's hugely impactful in terms of the potential to stave progression for a longer period of time. So that will be an important positioning concept commercial. Yeah, because what we're hearing a lot in the community, the kale community is The desire to use these kind of disease modifying quote unquote, if you will, therapies earlier in the process. And I think if our profile plays out from the OLE through to Procera, will have a very safe, tolerable, and effective agent that can be used very early along with the vasodilators like the PD-5 and ERA.
Speaker Change: <unk> lung and heart as we've seen by our imaging data in our echo data that.
Speaker Change: Hugely impactful in terms of the potential to stave off progression for a longer period of time.
Speaker Change: So that will be an important positioning concept commercially.
Speaker Change: Yes, because what we're hearing a lot in the <unk>.
Speaker Change: <unk> community is.
Speaker Change: The desire to use these kind of disease modifying quote unquote, if you will therapies earlier in the process and I think if our profile plays out from the <unk> through <unk>.
Speaker Change: We'll have a very safe tolerable and effective agent that can be used very early along with the base with di leaders like a PDE five and E <unk>.
Bob Smith: So, again, that's one of the rationale for the interest that we're getting for early utilization.
Speaker Change: So that's.
Speaker Change: That's one of the rationale for the interest.
Richard Aranda: So I could further comment on your question around the PHILD around dose. the potential impact. So, first, let me start off by saying that we're confident in the 90 milligram dose in PHILD given the results that we have in GLEAP1. Nonetheless, we believe it's important to acknowledge that, as we mentioned, PHILD represents basically two disease processes, one a vascular component with the pH and then a lung component characterized by the lung fibrosis. So factoring in some of the preclinical work that we have performed and was presented at the CHESS Conference in 2024 using fibrotic models, using human lung and fibroblast cells, which we showed a favorable effect.
Speaker Change: That we're getting for.
Speaker Change: Early utilization.
Speaker Change: So.
Speaker Change: I can further comment on your question around the ph ILD around dose.
Speaker Change: The potential impacts so.
Speaker Change: First let me start out by saying that we're confident in the 90 milligram dose in ph ILD given the results that we have increased one.
Speaker Change: Nonetheless, we believe it's important to acknowledge that.
Speaker Change: As we mentioned ph ILD represents basically two disease processes, one of vascular component with the ph and then that loan component characterized by the lung fibrosis. So factoring in some of the preclinical work that we have performed and was presented at <unk>.
Speaker Change: The chest conference in 2024.
Speaker Change: Using fibrotic models using human lung.
Bob Smith: The thought process is we wanted to deliver more drug to the lung, factoring in the fact that the lung architecture is already distorted due to the lung fibrosis. So we wanna ensure that sufficient exposure is occurring in the setting of that. If you recall that we have elevated the force vital capacity as a secondary endpoint, that was done intentionally because we believe that this could be a clear differentiating feature of this molecule in treating both the pH part and the lung disease part. So, assuming that we have positive results, not only would it be differentiating for us, but we would obviously have a discussion with regulators about potential mentioning of it or positioning of it in the product label.
Speaker Change: <unk>.
Speaker Change: Fibroblast cells.
Speaker Change: Which we showed a favorable effect.
Speaker Change: Process is.
We wanted to deliver.
Speaker Change: More more drug to the lung.
Speaker Change: Factoring in the fact that the lung architecture is already distorted due to its along fibrosis. So we want to ensure that sufficient exposure is occurring in the setting of <unk>.
Speaker Change: <unk>.
Speaker Change: Differences in the architecture.
Speaker Change: <unk>.
Speaker Change: If.
Recall that we have elevated dysfunctional forced vital capacity as a secondary endpoint.
Speaker Change: That was done intentionally because we believe that this could be a clear differentiating feature of this molecule in treating both the ph part and the.
Speaker Change: <unk> disease part and so.
Speaker Change: Assuming that we have positive results not only would it be differentiating for us, but we would obviously have a discussion with regulators about potential mentioning of it are positioning of it.
Patrick Tuccio: And maybe Bob would just want to comment on some of the commercial implications of all of this. of the FEC. Oh, okay. Yeah. So, commercially, it would be a huge differentiator, because right now, Tybaso looked at FEC as a safety endpoint in the study, whereas we're looking at it as an efficacy endpoint in the study. So, that would be a significant commercial differentiator for serolizumab. And I also think, Patrick, importantly, and in conjunction with our partners at Chiesi, having an efficacy signal on FBC would also be a significant barrier to entry in the European Union where no drugs are Terrific.
Speaker Change: And the product label and maybe Bob just want to comment on some of the commercial implications of that.
Speaker Change: Of this approach.
Speaker Change: Of the.
Speaker Change: The FTC.
Speaker Change: Oh, Okay, yeah, so commercially it would be a huge differentiator because rate right now today so.
Speaker Change: Looked at MVC as a safety endpoint in the study.
Speaker Change: Whereas we're looking at as an efficacy endpoint in the study so that would be a significant commercial differentiator for certainly the NIM and I also think Patrick importantly in conjunction with our partners at Crazy, having an efficacy signal on SBC would also be a significant barrier to entry.
Patrick Tuccio: Thanks so much. Thanks.
Speaker Change: In the European Union, where no drugs to treat.
Unknown Executive: Thank you.
Speaker Change: Terrific. Thanks, so much.
Laura Chico: Alright, next up we have Laura Chico of Wedbush. Hey, good afternoon. Thanks very much for taking the questions. I just have a couple here.
Speaker Change: Thanks.
Speaker Change: Okay.
Andreas Argo: All right next up we have Laura Chico of Wedbush.
Laura Chico: First, and I apologize, I'm just trying to reconcile some of the commentary around the geographic split on recruitment and Procera and some of the commercial dialogue you've had there. How do you think about the types of patients that would be more suited for serolutinib, presuming success in Procera versus a Cetatarcept patient. I'm just kind of curious, is there certain characteristics that might skew the market one way or another?
Laura Chico: Hey, good afternoon, and thanks for taking the questions I just have a couple here first.
Speaker Change: I'm just trying to reconcile some of the commentary around the geographic split on recruitment in for Sara and some of the commercial dialogue you've had there how do you think about the types of patients that would be.
Speaker Change: More suited for Sarah Loopnet presuming success in for Sara versus that's a pattern that patient I'm just kind of curious is there certain characteristics that might skew the market one way or another and then related is there or not I think I missed this but could you elaborate a little bit further this is kind of blazing new trails here trying to understand.
Faheem Hasnain: And then related to seronata, I think I missed this, but could you elaborate a little bit further? This is kind of blazing new trails here, trying to understand the powering assumptions around the primary endpoint, I guess, specifically on treatment effect and how you derive that. Thanks very much. Yeah, on the commercial side, you know, assuming positive ProSera, we will launch Seralutinib roughly three years after Sotatracept launched in the market. At that point, what you'll see is basically a market reset. So all the prevalent patients that are out currently out there will have tried Sotatracept, probably three quarters of them, not all patients are going to be good candidates for Sotatracept, but call it 70%.
Speaker Change: Powering assumptions around the primary endpoint I guess, specifically on treatment effect in how you derive that thanks very much.
Speaker Change: Yes on the commercial side.
Speaker Change: Assuming positive pro Sarah we will launch Sarah alluded at roughly three years after <unk> launched in the market at that point, what Youll see is basically a market reset so all of the prevalent patients.
Speaker Change: Currently out there.
Speaker Change: <unk> tried so chatter shaft, probably three quarters of them not all patients are going to be.
Faheem Hasnain: So by the time we launch, you'll have this market reset where patients have been on Sotatracept, have come off Sotatracept, that now have advanced in their progression of their disease. And that's kind of the large patient population theme spoken before. So we could potentially look at having a 70 to 80% of the market opportunity out there, because Sotatracept will probably have a 30% of the market in three years because of the discontinuations and just the normal progression of the market and the disease. In addition, I think there's a lot of interest as well to using both Seralutinib and Sotatracept in combination.
Speaker Change: Good candidates for <unk>.
So call it 70% so by the time, we launch you'll have this market reset where patients have been also counter set to come off so to intercept.
That now have advanced in their in their progression of their disease.
Speaker Change: The best chemical large patient populations theme spoke to spoken before so we could potentially look at having a 70% to 80% of the market opportunity out there because thats out except will probably have 30%.
The market in three years because of the discontinued ratios and just the normal progression of the market and the disease.
Faheem Hasnain: As Bryan mentioned, we only have, you know, very few patients in the study on that combination, but there are data that are being looked at both preclinically, and then we'll have a little bit of clinical data to suggest how these therapies could be used in combination. So if I take my crystal ball out to say, let's fast forward to the time that we launched, as Bob had said, say early 2027, all the points that Bob made is exactly right. So what we're gonna see is not only the patients that have tried Cetatarcept, failed, the patients that weren't eligible for Cetatarcept for one reason or another, and the patients who've been on Cetatarcept and overall treatment is waning, those patients that have been on Cetatarcept that may still be on Cetatarcept, but we're starting to see a waning of the effect.
Speaker Change: In addition, I think there's a lot of interest as well to using both loopnet and some patterns have been combination.
Speaker Change: As Brian mentioned, the Wheeling merger.
Speaker Change: Few patients in the study on that combination, but there are data that are being looked at both pre clinically and then we'll have a little bit of clinical data to suggest how these these therapies could be used in combination. So if I take my <unk>.
Speaker Change: Crystal ball up to say, let's fast forward to the time that we launch as Bob said say.
Speaker Change: Early 2027.
Speaker Change: And the point that Bob made is exactly right. So what we're going to see is not only the patients that have tried to tad or failed the patients.
Speaker Change: Born eligible for Soutache set for one reason or another.
Speaker Change: And the patients have been on to Tad Herceptin overall treatment as Wayne those patients that had been off the tariff set that may still be honest faddish set, but we're starting to see a waning of effect.
Faheem Hasnain: One can imagine doctors are going to be very encouraged to use combination therapy, especially given the preclinical evidence that's been generated thus far around the potential synergy between these two agents. But I think that, I think that seralutinib gets positioned as a drug to try first before seralutinib once we're in the market, as we see newer patients coming in. I think that is a potential just because, as you see it, for the to be able to see the potential to prevent longer-term progression, but also to be able to put these patients on a product with a safer profile, I think will be incredibly encouraging for doctors.
Speaker Change: One can imagine docs is going to be very encouraged to use combination therapy, especially given the preclinical evidence that's been generated thus far around the potential synergy between these two agents, but I think that.
Speaker Change: I think that.
Speaker Change: Sarah Loopnet gets positioned as a drug to try first before Sarah Loopnet. Once we're in the market as we see newer patients coming in I think that as a potential just because as you see it for the reasons that I mentioned to be able to see the potential to prevent longer term progression, but also to be able to.
Faheem Hasnain: So I think that's going to be a kind of an interesting marketing concept and positioning concept once we get it.
Speaker Change: Put these patients on a product with a safer profile I think will be incredibly encouraging for dogs.
Speaker Change: So I think that's going to be kind of an interesting marketing concepts and positioning concept once we get approved.
Richard Aranda: So I could answer your question around some of the powering assumptions around our PHLD six-minute walk. So I think, as you've mentioned, and as we stated, there's not a lot of precedent for randomized controlled trials, but we do have the increased trial that, you know, we could get the six-minute walk data from that particular trial. And so we, you know, we had to do some extrapolations. I just want to add two, maybe three points around trying to provide a framework, and then I'll get into the. Power Assumptions that we did. So as I mentioned, this is a very sick population.
Speaker Change: So I could answer your question around.
Speaker Change: Some of the powering assumptions around our ph ILD six minute walk so I think as you've mentioned and as we stated there's not a lot of precedent for a randomized controlled trials, but we do have the increase trial.
Speaker Change: But that we could get the six minute walk data from that particular trial and so we had to do some extrapolation.
Speaker Change: Just just want to add two maybe three points.
Speaker Change: Around trying to provide a framework and then I'll get into the to the power assumptions that we did so.
Richard Aranda: They're going to have lower six-minute walks than group one. And furthermore, over the course of a trial, they're likely going to deteriorate much more than group one. And I want to go back and look at the increased trial. That was a 16-week trial. Our trial is 24 weeks. So the assumption here is that those that are randomized to placebo are likely going to get worse than even in the increased trial. So that's one factor. Related to that, then, as In the active arm, we have assumed at least a 30-meter difference, much like what we did for group A, but we have some latitude there.
Speaker Change: As I mentioned this is a very sick population, they're going to have lower six minute walks in group one and Furthermore over the course of the trial there are likely going to deteriorate much more than group, one and want to go back and look at the increased trial that was a 16 week.
Speaker Change: Trial, our trial is 24 weeks so the assumption here is that.
Speaker Change: Those that are randomized to placebo are likely going to get worse than even in the increased trial. So that's that's one one factor.
Speaker Change: Related to that then.
Speaker Change: As in.
Speaker Change: In the active arm.
Speaker Change: We have assumed at least a 30 meter difference much like what we did for group.
Richard Aranda: If it's slightly less, likely more, we still have greater than 94, 95 percent power comparing the active arm versus group B. And that's also assuming a standard deviation of about 70.
Speaker Change: But we have some latitude there.
Speaker Change: If it's slight less like the more we still have greater than <unk>.
Speaker Change: <unk> 90, 495% powered comparing the active arm versus placebo and that's also assuming a standard deviation above 70.
Daniel: That's super helpful. Thank you, guys. Thank you.
Daniel: All right, next up we have Ali Merlay of UBS. This is Jasmine on for Ellie. Congratulations on all the progress and thanks so much for taking our question. So first, follow up to an earlier question, your comments. Are you allowing so-tat-or-sap drop-ins in Procera? And then more generally, how are you thinking about how looking at a combination effect here could impact the opportunity commercially? And then secondly, can you just talk about the population you're aiming to enroll in Serenata for PHILD? Do you think that similarly to PH, you'll see greater effects in the more severe range of patients here?
Speaker Change: That's super helpful. Thank you guys.
Speaker Change: Thank you.
Speaker Change: Alright next definitely is Ellie Merle.
Speaker Change: UBS.
Speaker Change: Hi, This is Jonathan Lee congratulations on all the progress and thanks, so much for taking our question. So first a follow up to an earlier question. Your comment are you, allowing some patterns that drop in and Coursera and then more generally how are you thinking about how looking at a combination effect here could impact.
Speaker Change: The opportunity commercially and then secondly can you just talk about the population you're aiming to enrolling serenata for ph ILD do you think that similarly could peak, you'll see greater effects in the more severe range of patients here.
Faheem Hasnain: Thanks. Yeah, in terms of the allowing patients who are on Cetatorcept into the Procera study, we actually do allow for patients who are on Cetatorcept, but of course, in order for them to get into the study, they need to actually qualify for the study, which means there is a period where they need to be on stable medication. Richard, you can kind of outline the criteria for Cetatorcept patients, eligible patients. Yeah, I mean, they have to be at least on background Cetatorcept for six months at a stable dose without changing due to hemoglobin or platelet changes, and then they still have to meet our PVR criteria of greater than 400, reveal like 2.0.
Speaker Change: Thanks.
Speaker Change: Yes in terms of the allowing <unk> patients who are on <unk> and <unk>.
Speaker Change: The process that we actually do allow for patients who are on Santander said, but of course in order for them to get into the study and they need to actually qualify for the study which means.
Speaker Change: There is a kind of.
Speaker Change: A period, where they need to be unstable medication. Richard you can kind of outline the criteria for its 10% of patients eligible patients yeah. Yeah, I mean, they have to be at least on background. So tighter set for six months at a stable dose without changing.
Speaker Change: Hemoglobin or platelet changes and then they still have to meet our PBR criteria of greater than 400 reveal like to point out.
Richard Aranda: that they all saw for 24 weeks, right? Yeah. Yeah, and so just given the kind of the stringent application of the entry criteria, you know, we will probably just get a handful of patients on cetatorcept. There really won't be a substantive number in the study given the time frame under which it's been launched and the access to patients who've been on for six months as Richard just laid out. But so the short answer is yes, we allow cetatorcept patients in, but they got to qualify in the context of the entry criteria, which will equate to a small number.
Speaker Change: Risk score greater or a PBR of greater than 800.
Speaker Change: So after 24 weeks for 24 weeks, yeah and so.
Speaker Change: Given the.
Speaker Change: The stringent application of the entry criteria, we will probably just get a handful of patients on Santander set there really won't be a substantive number in this study given the timeframe under which it has been launched and the access to patients who have been on for six months as Richard just laid out but so the <unk>.
Speaker Change: Short answer is yes, we Alaska Patterson patients in but they've got to qualify we context, the entry criteria, which will which will equate to a small number.
Richard Aranda: And then, yeah, I could comment, this is the target population for serotonin. Yeah, probably the best way to frame this is suggest to go back and look at the increased trial and their population. We have some similarities, but clearly some differences, and I can just highlight some of those differences. So first of all, our hemodynamic criteria are more stringent. We have four wood units for PVR. They had three wood units. That's because we do want to leverage the fact that there are more severe patients, and we would anticipate a greater treatment effect in those patients.
Speaker Change: Yeah.
Speaker Change: And then.
Speaker Change: Yeah.
Speaker Change: The target population for for certain on it yet probably the best way to frame. This is.
Speaker Change: [noise] suggest to go back and look at the increase trial and their population we have some similarities but clearly some differences in and I can just highlight some of those differences so.
Speaker Change: So first of all.
Speaker Change: Our.
Speaker Change: Hemodynamic criteria are more stringent we have four wood units for PV are they had three wood units.
Speaker Change: That's because we do want to.
Speaker Change: Leverage the fact that there are more severe patients and we would anticipate greater treatment effect in those patients.
Richard Aranda: In addition, we are targeting idiopathic interstitial pneumonia and IPF, systemic autoimmune disease-related pH, fibrotic interstitial pneumonitis, and occupational interstitial lung disease. Unlike increase, however, we're not allowing for combined pulmonary fibrosis or emphysema. We're not allowing sarcoid. either. And then we're much more stringent upon criteria around having CT scans reviewed by Central Reader and other things like that. And probably related to your question is, do we anticipate The more severe population that we would also observe a greater treatment effect, I think the answer is yes to that question. Great, that's helpful. So just to clarify, patients are not allowed to drop in or begin Zoterocept during Prothera.
Speaker Change: In addition, we are targeting.
Speaker Change: Targeting.
Speaker Change: Idiopathic interstitial pneumonia.
Speaker Change: <unk>.
Speaker Change: I P S.
Speaker Change: Systemic autoimmune disease related ph fibrotic, interstitial pneumonitis and occupational interstitial lung disease. Unlike increase however were not allowing for a combined pulmonary fibrosis.
Speaker Change: Emphysema, we're not allowing sarcoid.
Speaker Change: Either.
Speaker Change: We are.
Speaker Change: More stringent upon.
Speaker Change: Criteria around having a C T scans reviewed by by Central reader and other.
Speaker Change: Things like that so.
Speaker Change: And probably.
Speaker Change: Probably related to your question is do we anticipate.
Speaker Change: The more severe population that we would also observe.
Greater treatment effect I think the answer is yes to that question.
Speaker Change: Okay. Great. That's helpful. So just to clarify patients are not allowed to drop it begins at higher Sac Gary Chris Harris.
Jasmine: As far as dropping in with No. When you are enrolled, you have to be on state... Great, thanks so much for answering my questions. Thank you.
Speaker Change: As far as.
Speaker Change: Dropping in with stars.
Speaker Change: No.
Speaker Change: When you were enrolled you have to be honest.
Speaker Change: Right.
Speaker Change: Sure.
Jasmine: All right, and our final question in queue today is Vamil Devon of Guggenheim. Hi, this is Daniel on Vrvamo. Thanks for taking our questions. So, the first one is, you described Cerluna as a multi-billion dollar pH franchise, potentially. Maybe compare the commercial opportunity for this drug in PAH versus PHLD. And then my second question is just... if you can kind of go into more details around the expected... Video the review. Video Video Yeah, so in terms of the multi-billion dollar opportunity, if you look at PAH, there's about 50,000 patients in the US. If you look at the current pricing of the newer therapies, obviously we don't have, we haven't presented anything publicly, but if you look at the TatterSept right now is on...
Speaker Change: Great. Thanks, so much for answering my questions.
Speaker Change: Thank you.
Speaker Change: Alright, and our final question in queue today is the mill demand of Guggenheim.
Speaker Change: Hi, This is Daniel on for <unk>, Thanks for taking our questions.
Speaker Change: So the.
Speaker Change: The first one is.
Speaker Change: You described dilutive as a multibillion dollar.
Speaker Change: Franchise potentially.
Speaker Change: Can you maybe compare the commercial opportunity for this drug in K H versus ph ILD.
Speaker Change: And then my second question is just.
Speaker Change: Is it kind of like more details around the expected.
Speaker Change: Graphic distribution of enrollment for the ph ILD trial do you think it will be similar to what we saw on K H.
Majority seen internationally or is there less of a need for this in balance without.
Speaker Change: The wind Rivera dynamic at play.
Speaker Change: No Bob.
Speaker Change: Yes, so in terms of.
Speaker Change: [noise] multibillion multibillion dollar opportunity.
Speaker Change: If you look at <unk> about 50000 patients in the U S.
Speaker Change: If you look at the current pricing of.
Speaker Change: <unk>.
The newer therapies, obviously, we don't have we haven't presented anything publicly but if you look at the <unk> price.
Faheem Hasnain: about a billion and a half dollar running rate in its second full year. Right now, they're sitting at, I think, 5,800 patients or 5,200 patients have already started drug. And that continues to grow. So you can see the the opportunity within the PAH marketplace in terms of the number of patients and the potential price associated with it. In terms of the ILDPH, that market is probably three to four times greater than PAH. Call it roughly. you know, worldwide. 400,000, something like 400,000 patients. So again, and if you look at what Tyvaso is doing with their price point and number of patients, despite a very high number of discontinuations on that therapy, their run rate in PHILD is roughly 2 billion.
Speaker Change: You quickly switch out or set up right now is on.
Speaker Change: Billion $5 run rate in the second full year.
Right now they are sitting at 50 5800 patients or 5200 patients have already started drug.
Speaker Change: And that continues to grow so you can see the the opportunity within the PIH marketplace.
Speaker Change: In terms of the number of patients so the potential price.
Speaker Change: Associated with it in terms of the ILD ph that market is probably three to four times greater than ph.
Speaker Change: Call it roughly.
Speaker Change: Worldwide.
Speaker Change: 400000, something like 400000 patients.
Speaker Change: So again, if you look at what <unk> is doing with their price point and number of patients. Despite a very high number of just continuations of that therapy the run rate in.
Faheem Hasnain: Dan, to answer your question about geographic mix for Serenata, I do think it will be similar to ProSera. If anything, it may be an even larger contribution from the European Union, and that's really a function. Remember, the dynamics in ProSera is that, well, cetatorcept was not available in the European Union. There was an expectation that it was coming, so patients were saying, you know, I'll wait for cetatorcept before I go on a clinical trial. That dynamic doesn't exist, because inhaletibazo has not been approved, and there is, at least from what we can tell from looking at regulatory processes, there is not a plan for United's partner, Farrar, to get the drug registered in the European Union.
Speaker Change: In ph ILD is roughly $2 billion.
Speaker Change: Okay. James to answer your question about geographic mix for sure or not I do think it will be similar to <unk>.
Speaker Change: Pro Sarah if anything it may be even larger contribution from the European Union and that's really a function as I can remember the dynamics in pro Sarah as well so.
Speaker Change: So it was not available in the European Union, there was an expectation that it was coming so patients were saying.
Speaker Change: I'll wait for sits.
Speaker Change: <unk> before I go on.
Speaker Change: Trial that dynamic doesn't exist because inhaled <unk> Zoe.
Speaker Change: It has not been approved and there is at least when we can tell from looking at regulatory processes. There is not a plan for United's partner Farrar to get the drug registered in the European Union. So there isn't even greater unmet medical need in Europe for ph ILD therapies and there was for.
Faheem Hasnain: So there is an even greater unmet medical need in Europe for PHLD therapies than there was for PH therapies. So in summary, you've got a patient population, PHLD, that is much larger. significantly underserved with only one drug approved in the U.S. being type A, so I think type A is now... available in a couple of other smaller jurisdictions, but for the most part. only available in the U.S. with a sicker patient population than PAH, so. The unmet need is substantial and the opportunity, therefore, is also great.
Speaker Change: Ph therapies so.
Speaker Change: In summary.
Speaker Change: <unk> got a patient population.
Speaker Change: Child, the that is much larger.
Speaker Change: Significantly underserved with only one drug approved in the U S being <unk>. So I think Teva is now.
Speaker Change: Available in a couple of other smaller jurisdictions, but for the most part.
Speaker Change: Only available in the U S.
With a sicker patient population than P. A H.
Speaker Change: So.
Speaker Change: The unmet need is substantial and the opportunity. Therefore is also substantial.
Unknown Executive: Okay, great. Yeah, thank you very much. All right. Any other questions in the queue, operator? At this time, there are no further questions in queue.
Speaker Change: Okay, great. Thank you very much.
Speaker Change: Thanks.
Faheem Hasnain: Okay, I would just like to, first off, thank everybody for your participation on this call. We've enjoyed the opportunity to be able to speak with you and be able to outline the progress that we've made on Procera. We, of course, eagerly await the top-line results from this study, and for all the reasons that we've discussed today, we're very excited about the potential of serolubinib making a huge difference for patients. And I just want to end this call by first and foremost thanking those patients that have contributed. themselves to this study and to their physicians for having the confidence in Gossamer and Sarah Ludna to entrust us with treating their patients, the ability to treat their patients.
Speaker Change: All right any other questions in the queue operator.
Speaker Change: At this time there are no further questions in queue.
Speaker Change: Okay I would just like to first off thank you everybody for your participation on this call.
Speaker Change: We've enjoyed the opportunity to be able to speak with you and be able to outline the progress that we've made on Coursera. We of course eagerly await the top line results from this study.
Speaker Change: And for all the reasons that we've discussed today, we're very excited about the potential of Sarah Loopnet, making a huge difference for patients and I just want to end this call by first and foremost thanking the patients that have.
Speaker Change: <unk> contributed.
Speaker Change: Themselves.
Speaker Change: To this study and to there.
Speaker Change: Physicians for having the confidence in customer and Sarah Loopnet to entrust us with treating their patients the ability to treat their patients and lastly, I just want to thank the customer organization for the tireless effort over the last couple of years to be able to get us to where we are today. So thank you all and we look forward to being.
Faheem Hasnain: And lastly, I just want to thank the Gossamer organization for the tireless effort over the last couple of years to be able to get us to where we are today. So thank you all, and we look forward to being able to talk to you again, and certainly look forward to the top line results. Thanks, everybody.
Speaker Change: Talk to you again, and certainly look forward to the topline results on Prestea.
Unknown Executive: And with that, ladies and gentlemen, this does conclude your call. You may now disconnect your lines and thank you again for joining us today.
Speaker Change: Thanks, everybody.
Speaker Change: Yeah.
Speaker Change: And with that ladies and gentlemen. This does conclude your call. You may now disconnect your lines and thank you again for joining us today.