Q2 2022 Travere Therapeutics Inc Earnings Call

You are currently on hold for these <unk> therapeutics second quarter financial results and corporate update.

William Rote: Could that be rephrased for me, please?

At this time, you're assembling today's audience and plan to be on do we shortly we appreciate your patience and please remain on the line. Thank you.

[music].

Operator: You are currently on hold for this Travere Therapeutics Second Quarter Financial Results and Corporate Update.

Operator: Sure.

Good day and welcome to D Traviata Therapeutics second quarter financial results and corporate update today's conference is being recorded at this time I'd like to turn the conference over to D. CFO , Chris Clark. Please go ahead, Sir thank you.

Operator: You mentioned there were no stats performed in the EGFR data consistent with prior messaging.

Operator: At this time we are assembling to this audience and plan to be underway shortly.

Operator: We appreciate your patience and please remain on the line.

Operator: I'm sure there was consideration of doing some additional statistical work on that data, over various points in the past year.

Thank you Caroline good morning, and welcome distributor Therapeutics second quarter 2022 financial results and corporate update call. Thank you all for joining US today's call led by our Chief Executive Officer, Dr. Eric Today, Eric will be joined for the prepared remarks by Dr. Julie <unk>, Our Chief Medical Officer, Peter Hammer, Our Chief commercial officer, and our Chief Financial Officer, Laura Quake.

Operator: Thank you.

Operator: And having gone through the discussions with FDA, do you think having done that or being, able to deliver some additional data on that front would have helped dissuade some of their concerns?

Dr. Bill Rote senior Vice President of research and development will join us for the Q&A session.

Operator: Good day and welcome to the Travere Therapeutics Second Quarter Financial Results and Corporate Update.

Before we begin I would like to remind everyone that statements made during this call regarding matters that are not historical facts are forward looking statements within the safe Harbor provisions of the private Securities Litigation Reform Act of 1095.

Operator: Today's conference is being recorded.

Forward looking statements are not guarantees of performance they involve known and unknown risks uncertainties and assumptions that may cause actual results performance and achievements to differ materially from those expressed or implied by the statement.

Please see the forward looking statement disclaimer on the company's press release issued earlier today as well as the risk factors section in our forms 10-Q, and 10-K filed with the SEC.

In addition, any forward looking statements represent our views only as of the date such statements are made August 4th 2022, interpreters, specifically disclaims any obligation to update such statements to reflect future information events or circumstances that I will now turn the call over to Eric Eric.

Operator: At this time I would like to turn the conference over to the CFO, Chris Cline.

Operator: Thank you.

Thank you, Chris and good morning, everyone.

Chris Cline: Please go ahead, sir.

William Rote: Yeah, I think that's a tough one to answer.

Chris Cline: Thank you.

William Rote: I'm not sure if it would or it wouldn't have.

Yesterday afternoon, we provided a comprehensive regulatory update on our sports center and pegged that niche programs, which is where I will begin.

William Rote: For us, the key was preserving alpha for the endpoint of the study. We wanted to maintain our highest probability of success at the confirmatory endpoint, seeing, that as the primary goal. So we really made the decision to do it that way in order to ensure our best chance of, delivering this for FSGS patients.

Caroline: Thank you, Caroline.

Operator: Thank you.

Chris Cline: Good morning and welcome to Travere Therapeutics Second Quarter 2022 Financial Results and Corporate Update call.

Operator: We will take our next question from the line.

First the FDA recently communicated to us in our mid cycle review meeting for <unk> NDA in Iga nephropathy that the review process remains on track for our Paducah target action date of November 17th.

Operator: Laura Chico from WETSCH.

Laura Chico: Morning.

Laura Chico: Thanks very much for taking the question.

This strengthens our confidence that we're on the path to a potential approval of <unk> for Iga Nephropathy later this year.

Chris Cline: Thank you all for joining us.

Laura Chico: For clarification, I'm wondering if you could just comment on study retention in both duplex, and protect.

As such we are continuing our efforts to ready the organization for the first launch of <unk> and I am very pleased with the progress we've made to date.

Laura Chico: I guess, have discontinuations progressed as anticipated in both of these studies now, that we've had interim updates?

Laura Chico: And then a follow-up, I just wanted to clarify, so the mid-cycle review meeting has completed, with respect to IGAM, and obviously the agency has seen the interim FSGS data from duplex.

The second update is that we completed our planned Taipei interactions with the FDA to discuss the potential for accelerated approval of <unk> for <unk> and we received the final meeting minutes.

Laura Chico: I'm wondering if the FSGS data could somehow trigger an amendment or how that might impact, the IGAM review.

Laura Chico: I just wanted to clarify there.

Laura Chico: Thanks.

Following a collaborative interaction rather than submitting for accelerated approval this year.

Laura Chico: Laura, thank you for your questions.

Has recommended that we pursue traditional approval based on two year Egfr slope data following the completion of the duplex study next year.

Eric Dube: Jula, can you please take the question on study retention in duplex and pertex?

Jula Inrig: Yes.

It is disappointing that we will not be filing for accelerated approval. This year. It does not change our belief that <unk> has the potential to become a new treatment standard for F. S geos as well as Iga nephropathy if approved.

Chris Cline: Today's call will be led by our Chief Executive Officer, Dr. Eric Duvay.

Note, while the FDA reiterated again that we should not disclose detailed data from the ongoing study in order to assure trial integrity.

Hey, good aligned with us on sharing a few important elements with stakeholders.

Jula Inrig: So the studies have continued to progress with high quality.

The first is that the FDA recognizes the significant unmet need as well as the challenges in studying <unk> given its heterogeneity.

There have been few clinical trials completed to date to provide insight into this disease.

In many respects, we are leading the way and our duplex study is on track to deliver the largest controlled data set to date in the field.

The second point is that the Egfr data since the interim analysis in the duplex study was first reported in February of 2021, we've continued to progress in a matter consistent with.

With the profile of Sports Center.

And the third is that the FDA has indicated that the duplex study as designed maintains the potential to support full approval pending completion of the study and the FDA recommends that we pursue traditional approval based on two year Egfr slope.

These are important points as they support the fact that sports center is acting consistent with what we know from the history of its development and we are confident that the duplex study will ultimately enable us to pursue a submission for approval for <unk>.

We expect to have the two year Egfr slope and additional data available in the first half of next year.

Assuming <unk> is approved for Iga nephropathy, and we see supportive two year results from duplex, we will be in a position to submit a supplemental NDA or <unk> in the second half of next year.

With this update in the U S. We and our partners at <unk> for pharma has pivoted from a joint indication submission for both Iga nephropathy and <unk> in Europe .

To apply for conditional marketing authorization of <unk> for Iga nephropathy on its own this year.

Pending the completion and supportive data for full approval from the duplex study we are targeting an application for approval of <unk> in Europe by the end of next year.

The last update that we provided yesterday afternoon was that the FDA has granted breakthrough therapy designation to our pegged about <unk> program for HCM.

This is an exciting achievement and meaningful step forward for our program, particularly as we work to establish the biomarker pathway for a pivotal study in the U S and abroad for this devastating disease.

I will now turn the call over to jugal for a bit more on the regulatory update and clinical activity.

Chris Cline: Eric will be joined for the prepared remarks by Dr.

Jula Inrig: Oh.

Thank you, Eric and good morning, everyone.

Chris Cline: Jewel Inrig, our Chief Medical Officer, Peter Herma, our Chief Commercial Officer, and our Chief Financial Officer, Laura Klag.

Jula Inrig: Apologize for that.

I'd like to begin by recognizing the significant need for new non immunosuppressive treatment for people living with Iga nephropathy and FX, yes.

Chris Cline: Dr. Bill Roat, Senior Vice President of Research and Development, will join us for the Q&A session.

Jula Inrig: So the studies have continued to progress with very high quality, and we're seeing dropout, rates within the range of what you'd expect for nephrology studies of this length.

Chris Cline: Before we begin, I would like to remind everyone that statements made during this call regarding, matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties, and assumptions that may cause actual results, performance, and achievements to differ materially from those expressed or implied by the statement.

We continue to hear from the nephrology community and from patients that the available treatment options are limited and their effectiveness have a challenging side effect profile or have long term safety concerns.

As a result, many patients are left rapidly progressing to end stage kidney disease.

Chris Cline: Please see the forward-looking statement disclaimer on the company's press release issued earlier, today, as well as the risk factors section in our Forms 10-Q and 10-K file with the SEC.

We also continue to hear that Nephrologists are looking to the future and see promise for the evolution of the treatment paradigm in Iga nephropathy and FSD, yes.

We believe that physicians will be looking to use a foundational treatment alongside other modalities to provide their patients with the greatest chance of sustained proteinuria reduction over time.

We believe our content as the potential first non immuno suppressive therapy.

For Iga nephropathy, NFS Cts will become this foundational treatment if approved.

Chris Cline: In addition, any forward-looking statements represent our views only as of the date such, statements are made, August 4, 2022. And Travere specifically disclaims any obligation to update such statements to reflect future, information, events, or circumstances.

Jula Inrig: And we, as you can imagine, have put a significant amount of effort to make sure that we maintain, the patients in both studies.

I am proud of our team's execution in the second quarter.

Chris Cline: With that, I'll now turn the call over to Eric.

And our Iga Nephropathy program, we were pleased that the NDA for <unk> was accepted by the FDA and granted priority review.

Eric Dube: Eric?

Eric Dube: Thank you, Chris.

Furthermore, we were pleased with the outcome of our recently completed mid cycle review meeting and.

Eric Dube: And good morning, everyone.

Eric Dube: Yesterday afternoon, we provided a comprehensive regulatory update on our Sparsentin and PEG, to Batinase programs, which is where I will begin.

And its interaction with the FDA indicated that the review process remains on track for our assigned.

Eric Dube: First, the FDA recently communicated to us in our mid-cycle review meeting for the Sparsentin, NDA and IgA nephropathy that the review process remains on track for our PDUFA target action date of November 7. This strengthens our confidence that we are on the path to a potential approval of Sparcentin, for IGNephropathy later this year.

<unk> action date of November 17th 2022.

And they reiterated that they are not planning for an advisory committee to discuss the application.

Eric Dube: As such, we are continuing our efforts to ready the organization for the first launch, of Sparcentin, and I am very pleased with the progress we have made to date. The second update is that we completed our plan to type A interactions with the FDA to, discuss the potential for accelerated approval of Sparcentin for FSGS, and we received the final meeting minutes. Following a collaborative interaction, rather than submitting for accelerated approval this, year, the FDA has recommended that we pursue traditional approval based on two-year EGFR slope data following the completion of the duplex study next year.

We have also successfully completed our onsite sponsor good clinical practice or TCP inspection.

Jula Inrig: And so we're very proud of the efforts that we've put into this and with the retention, rates that we're seeing today.

I'm very pleased with the high quality standard that our clinical and operational teams have met throughout the protect study.

Eric Dube: While it is disappointing that we will not be filing for accelerated approval this year, it does not change our belief that Sparcentin has the potential to become a new treatment standard for FSGS, as well as IGNephropathy, if approved.

As such we believe we are in a strong position as we continue moving towards the target action date in November .

We know that medical education is a foundational point for enabling firsthand tend to become a new treatment standard.

In the last six months, we've expanded our medical team to effectively deliver Iga nephropathy disease State education more broadly to the nephrology community and we're seeing strong engagement.

Additionally, we continue to work closely with the incredible patient advocacy groups in the nephrology field.

This collaboration we're able to provide disease state education and develop important insights into the patient journey that will help us Bethany patients' needs.

We also recently received clear definition on our path forward for FSD, yes.

William Rote: And Bill, would you like to take the question on the mid-cycle review and the data availability, and how that might impact FDA's review?

As Eric mentioned earlier, the FDA has recommended that we proceed with traditional approval following receipt of the two year Egfr data from the duplex study of Santana NFS, Jeff rather than pursuing accelerated approval.

Eric Dube: Of note, while the FDA reiterated again that we should not disclose detailed data from, the ongoing study in order to assure trial integrity, they did align with us on sharing a few important elements with stakeholders.

William Rote: Certainly.

I will go into some of the details of our interaction, but it's important to first highlight why we are in a situation where FDA support accelerated approval on one indication for <unk>, but not another.

William Rote: The FDA, throughout our development program, has consistently pointed to evaluating these, two programs independently, and this remains the case.

William Rote: They're different diseases.

Eric Dube: The first is that the FDA recognizes the significant unmet need, as well as the challenges, in studying FSGS, given its heterogeneity. There have been few clinical trials completed to date to provide insight into this disease.

William Rote: They are studied on their own, and they have trial designs that are different, and there, are key differences between them that we've highlighted.

As we know the bar for accelerated approval, which would be the first in that first yes, it's high.

William Rote: They did have the data sets and vision to both programs the whole way through.

Eric Dube: In many respects, we are leading the way, and our duplex study is on track to deliver, the largest controlled data set to date in the field.

William Rote: So at the point of their mid-cycle review meeting, they were aware of the duplex data, and there was no expression of concern on their part as a result of those, the duplex data.

We believe FDA is requiring a high degree of assurance with a limited dataset in a patient population that's more heterogenous and challenging the study then Iga nephropathy.

In essence, we're paving the way for office, Jeff with the duplex study.

We also have design differences between the duplex and protect studies.

We have historically talked about are important to consider.

As many of you will recall duplex did not require a run in period on Max tolerated Acer IRB.

And it had a two week washout of rasp inhibition before patients received study drug.

Without specifically speaking to duplex or protect one would expect a larger change in initial egfr with different background medications and a washout period. So this is important to note.

We also know from the history of smartphone <unk> and the phase two duet study and experience with other <unk> that there was an initial effect on egfr with endothelin blockade over and above RAF inhibition alone.

This means when you think about total egfr slope, which starts the measurement at baseline you would expect to have a larger initial difference to overcome with the washout and no running on uniform background medications.

And our interim assessment last February we had already established a clinically meaningful difference in proteinuria reduction.

So the goal of the plant type a meeting with to provide a more mature data cut of Egfr data and see if that met the FDA threshold for accelerated approval.

William Rote: It was in that frame that they gave us very clear feedback and that we were on track, that there was no plan for an ADCOM was reiterated, and that we are looking forward to our action date in November.

Our meeting with the agency, we shared the limited additional Egfr data that was pulled from the duplex study, which was taken at a point when all patients had been in the study for at least one year slightly less than half of patients had been at zero for two years.

In order to preserve alpha in a study we did not do any statistical analysis on the Egfr data the data were purely disruptive in nature.

Eric Dube: The second point is that the EGFR data, since the interim analysis in the duplex study was, first reported in February of 2021, we have continued to progress in a manner consistent with the profile of Sparcentin.

William Rote: Thanks very much.

As Eric highlighted earlier since the interim analysis in the duplex study that was reported in February of last year the.

Laura Chico: Thank you.

The Egfr data have continued to progress in a manner consistent with the profile for sometime.

Operator: We will take our last question from line Ed Witnesz from Kennecott.

Operator: The line is open now.

This is expected and encouraging test.

Operator: Please go ahead.

However, the FDA indicated that the interim analysis conducted last year together with our recent limited additional egfr data do not meet their threshold to support an application for accelerated approval NFS, yes.

Ed Witnesz: Hi.

Ed Witnesz: Thanks, guys, for taking my question, and I really appreciate the clarity on the FSDS, here in the States and in Europe.

Eric Dube: And the third is that the FDA has indicated that the duplex study, as designed, maintains, the potential to support full approval pending completion of the study, and the FDA recommends that we pursue traditional approval based on two-year EGFR slope.

Ed Witnesz: I guess my question is just specific to Europe.

Importantly, the FDA noted in the meeting and the minutes reflected that the duplex study as designed maintains the potential to support full approval pending completion of the study and they recommended that we pursue traditional approval based on two year Egfr slope.

Eric Dube: These are important points, as they support the fact that Sparcentin is acting consistent, with what we know from the history of its development, and that we have confidence that the duplex study will ultimately enable us to pursue a submission for approval for FSGS.

Ed Witnesz: It would just be clearly it's a risk averse to position to kind of wait for European filing, also on FSDS, but just wanted to know, do you guys feel confident that it would probably turn out the same way with Europe if you went ahead and did the combined filing, that the Europeans would also kind of view the same issue and see that increased heterogeneity, would require to see data out to two years?

Ed Witnesz: Or is it also that just by filing together that that would risk the IGAN approval there, if you have both going at the same time?

Ed Witnesz: Ed, thanks for the question.

Eric Dube: We expect to have the two-year EGFR slope and additional data available in the first, half of next year.

William Rote: I'll turn that one over to Bill.

We expect to have those data in house in the first half of next year and assuming for Santana is approved for Iga nephropathy to be in position to submit an NDA in the second half of next year.

Eric Dube: Assuming Sparcentin is approved for IJ nephropathy, and we see supportive two-year results from, duplex, we will be in a position to submit a supplemental NDA or SNDA in the second half of next year.

William Rote: Sure.

William Rote: I mean, ultimately, our commitment here is to get Sparsens into patients as fast as possible, and that remains unchanged.

Finally on <unk>, we are working closely with our partner <unk> pharma to align our regulatory strategies for the U S and Europe .

William Rote: While we believe there is a case to be made to putting the two together in combination, we felt that that would be adding a potential incremental risk to the probability of an IGAN approval and, therefore, risking our ability to deliver Sparsens to those patients as quickly as possible if the EMA were to end up with the same view as the FDA.

Eric Dube: With this update in the U.S., we and our partners at B4 Pharma have pivoted from a joint indication, submission for both IJ nephropathy and FSGS in Europe to apply for conditional marketing authorization of Sparcentin for IJ nephropathy on its own this year.

William Rote: We're now strategically aligning with our partners before on the regulatory process, so that we have the best probability of success for both applications in Europe, and we look forward to getting the first potential approval in IGAN next year.

Following <unk> update from FDA were applying for conditional marketing authorization for Santana in Iga nephropathy in Europe .

Eric Dube: Thank you for joining us this morning for all of our updates.

Eric Dube: We have an exciting second half of the year ahead and we look forward to sharing more, updates along the way.

We anticipate a review decision in the second half of 2023 and the potential for a subsequent FX, Jeff submission pending duplex completion and supportive data potentially by the end of next year.

Operator: Have a great rest of the day.

Operator: This concludes today's call.

Eric Dube: Pending the completion and supportive data for full approval from the duplex study, we, are targeting an application for approval of FSGS in Europe by the end of next year.

Operator: Thank you for your participation.

Operator: You may now disconnect.

Eric Dube: The last update that we provided yesterday afternoon was that the FDA has granted breakthrough, therapy designation to our PEG-to-Batinase program for HCU. This is an exciting achievement and meaningful step forward for our program, particularly, as we work to establish the biomarker pathway for a pivotal study in the U.S. and abroad for this devastating disease.

Our <unk> program continues to progress and I'm very pleased that we recently received breakthrough designation from the FDA.

Jula Inrig: I will now turn the call over to Jula for a bit more on the regulatory updates and clinical, activity.

This designation recognizes the significant need for new treatment options for people living with Hamilton scenario and.

And the promising data that has been generated to date in the post study.

In the coming months, we're aiming to complete our discussions with the FDA and EMA on utilizing total homeless athene as an approvable biomarker endpoint.

From there we expect to engage in a multi disciplinary meeting afforded by breakthrough therapy designation to gain alignment on all aspects of our pivotal program.

This approach is designed to enable us to construct a pivotal study with a high potential for success and we look forward to the organizational commitment from the FDA as we continue to make progress.

In parallel the composed study continues to progress with patients on the highest dose of one five milligrams per kilogram and the open label extension and with additional enrollment activities continuing for the sixth cohort.

We also continue to focus on working through ongoing global supply constraints to scale CMC and manufacturing for the pivotal phase of <unk> development and ultimate commercial access.

Let me now turn the call over to Peter for the commercial update Peter.

Jula Inrig: Jula?

Jula Inrig: Thank you, Eric, and good morning, everyone.

Thank you Julien.

I am pleased with the commercial organizations execution during the second quarter.

We have continued to make strong progress both with.

And with our preparations for potential launch of spar symptoms of Iga Nephropathy later this year.

During the second quarter, we saw strong demand but.

But as we have talked about earlier this year, we are seeing impactful generic dynamics affecting net sales.

We expect that there will be a continued downward price you assume the balance of the year as the market competition.

But I'm very pleased with how our team continues to identify sweet and support patients in the system really a community.

As a portfolio.

The demand for global performed well during the quarter.

Do you need to expect growth of the bile acid portfolio in the second half of the year.

Supporting global is another Great example of our team's ability to identify patients with rare diseases.

Easily identified.

Our commercial organization is one that historically delivered year over year organic growth in seven consecutive years was able to achieve more than 85% utilization of new formulation was in the first nine months of loss. It has consistently been able to provide necessary services to support patients with rare.

Diseases.

We are building a whole new strengths and we are making great strides to be ready for a potential approval of <unk>.

As an organization that is uniform alignment and beliefs.

We're looking to achieve our vision of making star syndrome foundational therapy for patients with Iga nephropathy and Es is approved.

I am very pleased to report that we have completed the recruitment of our field force.

So both Barr syndrome for Iga nephropathy at launch if approved.

I believe we have assembled a world class team.

And I'm pleased to note that they have an average of almost 20 years, especially experienced in nearly all the clinical account just has strong nephrology experience.

We just recently that will kick off meeting with the full team and I can tell you that there is great excitement about the opportunity gets Barr syndrome may provide for patients if approved.

Key members express.

Awesome.

Can be involved in the launch of a product that has the potential to become a new treatment standards.

In parallel to preparing the infrastructure and team to support sparse and if approved we are also increasing our understanding of the Iga nephropathy market through research and payer engagements.

Jula Inrig: I'd like to begin by recognizing the significant need for new non-immunosuppressive treatments, for people living with IgA nephropathy and FSGS. We continue to hear from the nephrology community and from patients that the available treatment, options are limited in their effectiveness, have a challenging side effect profile, or have long-term safety concerns.

As <unk> highlighted earlier.

Difficult needs, new treatment options to meaningfully reduce that Emilio.

Allow for potential combination and that did not have the long term effects of immune suppression.

Jula Inrig: As a result, many patients are left rapidly progressing to end-stage kidney disease.

The results from our Iga Nephropathy research and payer engagements are consistent with what we are hearing from the metrology thought leaders, which adds confidence to our beliefs that the profile of spar symptom supports foundational use.

Notably.

Julia reduction continues to resonate as the top political barometer for <unk>.

Jula Inrig: We also continue to hear that nephrologists are looking to the future and seek promise, for the evolution of the treatment paradigm in IgA nephropathy and FSGS.

Jula Inrig: We believe that physicians will be looking to use a foundational treatment alongside, other modalities to provide their patients with the greatest chance of sustained proteinary reduction over time.

And there is an increasing urgency to treat patients with Iga nephropathy, both one gram per day.

This is largely driven by the belief that if.

As you can get the patients below one gram per day dosing.

Then there will be a benefit from long term egfr and better renal survival.

Research also suggests that steroids minimus Asia remains a key goal for nephrologists in treating patients with Iga nephropathy and that they would use a product profile like sports anthem potentially in combination with other treatment options if needed.

To optimize the chance for the patients to reduce cost in the area and stabilized disease progression.

Additionally, we are pleased with how the potential value proposition sparse in the night.

<unk> and Iga nephropathy is resonating and our payer engagements.

There is a strong understanding of the utility of clinically meaningful reductions in proteinuria and Iga nephropathy.

Especially if they are introduced before significant progression of disease.

That value proposition increases linked combined with a comparable safety profile to current treatment standards, such as Ace inhibitors and <unk>.

Lastly from a supply perspective, we are already positioned to ensure product availability for strong lungs.

Jula Inrig: We believe Sparcentin as the potential first non-immunosuppressive therapy to be indicated, for IgA nephropathy and FSGS will become this foundational treatment if approved.

Overall, we believe that the external feedback from patients nephrologist and patients and payers to get at was the internal strengths of our recently expanded commercial team, we will will enable us to achieve our vision of making <unk> syndrome, the foundational therapy for patients with Iga nephropathy.

Roofs.

And assign though.

The 3% to two potential launches for <unk> that will allow us to be incredibly focused on the best thoughts.

Property and also apply these learnings and experiences.

The IGN subsea launch to have a strong launch.

In 2024 if approved.

I will now turn the call over to Laura for a financial update.

Laura.

Thank you Peter.

Jula Inrig: I am proud of our team's execution in the second quarter.

For the second quarter of 2022, we reported total revenue of $54 2 million consisting of approximately $51 million and net product sale and $3 2 million in collaboration revenue from our European collaboration with <unk> pharma.

Jula Inrig: In our IgA nephropathy program, we were pleased that the NDA for Sparcentin was accepted by, the FDA and granted priority review.

This compares to $54 6 million in net product sales reported for the same period in 2021.

As we typically see in the second quarter gross to net discounts narrow following the insurance coverage changes that typically impact first quarter sales.

Jula Inrig: Furthermore, we were pleased with the outcome of our recently completed mid-cycle review, meeting. In this interaction, the FDA indicated that the review process remains on track for our, assigned PDUFA target action date of November 17, 2022, and they reiterated that they are not planning for an advisory committee to discuss the application. We have also successfully completed our onsite sponsor Good Clinical Practice, or GCP, inspection.

Jula Inrig: I'm very pleased with the high quality standards that our clinical and operational teams have, met throughout the PROTECT study.

Reported a GAAP net loss of $67 million for the second quarter of 2022.

Jula Inrig: As such, we believe we are in a strong position as we continue moving towards the target action, date in November.

After adjusting for noncash expenses and income tax we reported a non-GAAP net loss of $41 3 million for the second quarter of 2022.

Jula Inrig: We know that medical education is a foundational point for enabling Sparcentin to become a, new treatment standard.

Jula Inrig: In the last six months, we've expanded our medical team to effectively deliver IgA nephropathy, disease state education more broadly to the nephrology community, and we're seeing strong engagement.

Jula Inrig: Additionally, we continue to work closely with the incredible patient advocacy groups, in the nephrology field. Through this collaboration, we're able to provide disease state education and develop, important insights into the patient journey that will help us best meet patients' needs.

Jula Inrig: We also recently received clear definition on our path forward for FSGS. As Eric mentioned earlier, the FDA has recommended that we pursue traditional approval following, receipt of the two-year EGFR data from the duplex study of Sparcentin and FSGS, rather than pursuing accelerated approval.

Jula Inrig: I'll go into some of the details of our interaction, but it's important to first highlight why, we're in a situation where FDA supports accelerated approval in one indication for Sparcentin but not another.

Jula Inrig: As we know, the bar for accelerated approval, which would be the first in FSGS, is high. We believe FDA is requiring a high degree of assurance with a limited data set in a, patient population that's more heterogeneous and challenging to study than IgA nephropathy.

Jula Inrig: In essence, we're paving the way for FSGS with the duplex study. We also have design differences between the duplex and PROTECT studies that, as we have, historically talked about, are important to consider. As many of you will recall, duplex did not require a run-in period on max-tolerated Acer, ARB, and it had a two-week washout of RAS inhibition before patients received study drug.

Jula Inrig: Without specifically speaking to duplex or PROTECT, one would expect a larger change, in initial EGFR with different background medications and a washout period, so this is important to note.

Jula Inrig: We also know from the history of sparsentin in the Phase II duet study and experience, with other ETAs that there is an initial effect on EGFR with endothelin blockade over and above RAS inhibition alone.

Jula Inrig: This means when you think about total EGFR slope, which starts the measurement at baseline, you'd expect to have a larger initial difference to overcome with the washout and no run-in on uniform background medication.

Jula Inrig: In our interim assessment last February, we had already established a clinically meaningful, difference in proteinuria reduction, so the goal of the planned type A meeting was to provide a more mature data cut of EGFR data and see if that met the FDA's threshold for accelerated approval. In our meeting with the agency, we shared the limited additional EGFR data that was, pulled from the duplex study, which was taken at a point when all patients had been in the study for at least one year and slightly less than half of patients had been observed for two years.

On a GAAP basis, R&D expenses were $59 7 million for the second quarter of 2022.

Jula Inrig: In order to preserve alpha in the study, we did not do any statistical analyses on the, EGFR data. The data were purely descriptive in nature. As Eric highlighted earlier, since the interim analysis in the duplex study that was reported, in February of last year, the EGFR data have continued to progress in a manner consistent with the profile of Farcentin. This is expected and encouraging to us.

Jula Inrig: However, the FDA indicated that the interim analysis conducted last year, together with, the recent limited additional EGFR data, do not meet their threshold to support an application for accelerated approval in FSGS. Importantly, the FDA noted in the meeting and the minutes reflected that the duplex, study, as designed, maintains the potential to support full approval pending completion of the study, and they recommended that we pursue traditional approval based on two-year, EGFR slope.

Jula Inrig: We expect to have those data in-house in the first half of next year, and assuming Farcentin, is approved for IJ nephropathy, to be in position to submit an SNDA in the second half of next year.

Jula Inrig: Finally, on Farcentin, we are working closely with our partner, V4 Pharma, to align our, regulatory strategies for the U.S. and Europe.

Jula Inrig: Following the FSGS update from FDA, we're applying for conditional marketing authorization, of Farcentin in IJ nephropathy in Europe.

Jula Inrig: We anticipate a review decision in the second half of 2023, and the potential for a subsequent, FSGS submission pending duplex completion in support of data, potentially by the end of next year.

The increase compared to 2021 is largely attributable to increased head count as well as medical affairs activities to support the continued advancement of <unk> and <unk> programs.

On an adjusted basis R&D expenses were $54 4 million for the second quarter of 2022.

Relevant noncash expenses for the fourth quarter included $5 3 million of stock based compensation and amortization.

On a GAAP basis, selling general and administrative expenses for the second quarter of 2022 were $53 million.

The increase compared to 2021 is largely attributable to increased headcount and commercial launch preparation.

On an adjusted basis SG&A expenses for the second quarter of 2022 were $37 5 million.

Inefficient noncash adjustments for the quarter consisted of $15 4 million in stock based compensation and depreciation and amortization.

From an operating expense perspective, we anticipate that our R&D expenses will increase from current levels and it may be uneven quarter to quarter. As we continued to invest in ongoing clinical work and long term supply for both for certain and take to that Nate.

Consistent with our planning from the beginning of the year.

Increases in SG&A from second quarter level as we now have the full field for staff and continue to prepare for the potential for certain launch in Iga nephropathy.

As we enter the second half of the year, we continue to be in a strong financial position to execute.

We ended the second quarter with $553 2 million in cash and cash equivalents.

Notable onetime payments made during the second quarter consisted of an $8 million milestone payment to ligand for the NDA submission for Iga nephropathy.

Importantly, we believe this cash balance can support our operations into 2024, which takes into account potential further competitive pressure on cellular.

Investing in <unk> launches.

For both Iga nephropathy and <unk> as.

As well as milestone payments, we expect to pay related to regulatory achievements first part setting and take about knees.

As this will be my last call as CFO I would like to thank our incredible finance team and all of you for your continued support and engagement over the last eight years.

The future of trivia remains incredibly bright and I look forward to working closely with Chris and the rest of the management team through early next year to ensure a smooth transition.

Let me now hand, the call back over to Eric for his closing comments Eric.

Thank you Laura.

Overall, we continue to execute towards our vision of being a leader in the global rare disease community.

We are doing this through the continued development of our pipeline with the objective of positioning yet for sustainable diversified growth for years to come.

And by strengthening our organization to support broad access to our medications and meet the needs of patients as our products become available. We are entering the second half of the year, having made significant progress towards our goal of <unk>, becoming a new treatment standard for rare kidney disorders.

The review process for our NDA for Iga Nephropathy remains on track and we are in great shape preparing the organization and we will be fully ready to launch come November if approved we now know that we will have to wait a bit longer for FSD, yes, but the fundamental value and our confidence in <unk> and has not changed.

We believe it is a matter of difference in time, and we will put that to good use.

While we are awaiting the results of the full two year Egfr data from duplex, we will take the opportunity to focus even more sharply on the launch of Iga nephropathy, if approved and applying those learnings to commercialization of <unk> in the future if approved.

Jula Inrig: Our PECTIBATINASE program continues to progress, and I'm very pleased that we recently received, breakthrough designation from the FDA. This designation recognizes the significant need for new treatment options for people, living with homelessness scenario, and the promising data that has been generated to date in the COMPOSE study.

Additionally, now with breakthrough therapy designation granted for pegged about base. We believe we will be able to efficiently in line with regulators on a pivotal program that will give us the best chance of success and delivering the potential first disease modifying therapy to a community in need of new treatments.

Jula Inrig: In the coming months, we're aiming to complete our discussions with the FDA and EMA on utilizing, total homelessness seen as an approvable biomarker.

Jula Inrig: From there, we expect to engage in a multidisciplinary meeting afforded by Breakthrough Therapy, designation to gain alignment on all aspects of our pivotal program.

Operator: [inaudible] .

I would like to extend one final. Thank you to Lora for her incredible service and leadership.

And also reiterate what she said earlier the future is incredibly bright attributable.

Jula Inrig: This approach is designed to enable us to construct a pivotal study with a high potential, for success, and we look forward to the organizational commitment from the FDA as we continue to make progress.

Jula Inrig: In parallel, the composed study continues to progress with patients on the highest dose, of 1.5 milligrams per kilogram in the open label extension, and with additional enrollment activities continuing for the sixth cohort.

Jula Inrig: We also continue to focus on working through ongoing global supply constraints to scale, CMC and manufacturing for the pivotal phase of PEG-2-Vapnase development and ultimate commercial access.

And I look forward to continued execution through the balance of the year.

Now, let me turn the call over to Chris for Q&A.

Peter Heerma: Let me now turn the call over to Peter for the commercial update.

[music] ,

Peter Heerma: Peter?

Thanks, Eric Caroline can I. Please go ahead and open up the lines for Q&A.

Peter Heerma: Thank you, Jula.

Thank you if you would like to ask a question. Please signal by pressing star one on your telephone keypad, if you're using a speaker phone. Please make sure your mute function is to.

Peter Heerma: I am pleased with the commercial organization's execution during the second quarter.

Peter Heerma: We have continued to make strong progress, both with the approved products and with our, preparation for a potential launch of sparse sentinel-ideated property later this year.

Peter Heerma: During the second quarter, we saw strong demands for Thiola, but as we have talked about earlier, this year, we are seeing the impact of generic dynamics affecting net sales.

Peter Heerma: We expect there will be a continued downward pressure through the balance of the year as, the market competition evolves, but I am very pleased with how our team continues to identify, treat, and support patients in the Cystinuria community.

Peter Heerma: The bio-acid portfolio, led by demand for Colbon, performed well during the quarter, and we continue to expect growth of the bio-acid portfolio in the second half of the year.

Peter Heerma: Using Colbon is another great example of our team's ability to identify patients with, rare diseases that are not always easily identified or understood.

To reach our equipment. Once again, please press star one to ask a question we will take the first question from the line Tim Lugo from William Blair. Your line is open now. Please go ahead.

Peter Heerma: Our commercial organization is one that historically delivered year-over-year organic growth for, seven consecutive years, was able to achieve more than 85% utilization of a new formulation within the first nine months of launch, and has consistently been able to provide necessary services to support patients with rare diseases. We are building upon these strengths, and we are making great strides to be ready for, potential approval of SparCentrum this fall.

Peter Heerma: As an organization, there is uniform alignment and belief in the ability to achieve our vision, of making SparCentrum foundational therapy for patients with IgA nephropathy and FHEF as if approved.

Peter Heerma: I am very pleased to report that we have completed the recruitment of our field force, that will support SparCentrum for IgA nephropathy at launch, if approved.

Peter Heerma: I believe we have assembled a world-class team, and I'm pleased to note that they have, an average of almost 20 years of specialty experience, and nearly all of the clinical account managers have strong nephrology experience.

Peter Heerma: We just recently had our kickoff meeting with the full field team, and I can tell you that, there is great excitement about the opportunity that SparCentrum may provide for patients if approved.

The question and congratulations Laurel and all your work over the past years.

I wanted to.

It doesn't.

I just wanted to verify.

And be clear.

Two year data from.

Duplex.

The SBA able to look at I know, you, obviously had a little bit over half of our patients.

Two years.

But I believe you mentioned to preserve Alpha you did not run Scott.

All of these patients for proteinuria.

And.

Also I just know that you expected to launch in Iran.

Steroid therapy already on the market can you talk a bit about.

Are you expecting the initial patient bullet two starts for our center hopefully post approval will be those who have already progressed on the.

On <unk> therapy.

Peter Heerma: Team members expressed that it's not often they get to be involved in the launch of a, product that has the potential to become a new treatment standard.

Tim Good morning, and thanks for the questions I'll ask.

Bill to take the first question on what data was available for FDA and then I'll ask Peter to talk about how we're thinking about the early.

Uptake of <unk> once approved.

Yes. Good morning, good morning, Tim Thanks for the question with our agreement with the agency there was very little.

Done with the Egfr data and that was a deliberate strategy to preserve.

The alpha for the study so what we provided was a descriptive look at the composite of all available Egfr data for the <unk> arm and.

The irbesartan treatment arm, so it wasn't broken out specifically based on.

With those that were at two years versus those that were at one year. It was combined together and they look at the aggregate of that.

Egfr data plan.

If that helps you, but it's.

Divided into specific groups based on duration and the scope.

Okay. That's helpful. Thank you.

Peter Heerma: In parallel to preparing the infrastructure and team to support sparseness in the field, if approved, we are also increasing our understanding of the IGA and property markets through research and payer engagements.

Peter Heerma: As Jula highlighted earlier, there is a significant need for new treatment options that meaningfully, reduce poteneria, allow for potential combination, and that do not have the long-term effects of immunosuppression.

Peter Heerma: The results from our IGA and nephropathy research and payer engagements are consistent with, what we are hearing from the nephrology thought leaders, which adds confidence to our belief that the profile of sparse symptom supports foundational use.

Peter Heerma: Notably, poteneria reduction continues to resonate as the top clinical parameter for, nephrologists, and there is an increasing urgency to treat patients with IGA nephropathy who are above one gram per day. This is largely driven by the belief that if a physician can get their patient below, one gram per day of poteneria, then there will be a benefit on long-term EGFR and better renal survival.

Thank you.

Peter Heerma: Research also suggests that steroids minimization remains a key goal for nephrologists in treating, their patients with IGA nephropathy and that they would use a product profile like sparse symptom, potentially in combination with other treatment options if needed, to optimize the chance for their patients to reduce poteneria and stabilize disease progression.

For Europe .

For your question.

So I'll answer the question on your bonus you have an additional question to bill.

Yes.

Oh no.

Open to hear from you Peter on the launch versus the <unk>.

A bolus of patients what do you expect that they will be kind of failing budesonide or other steroids.

Excellent thanks for that Tim.

Peter Heerma: Additionally, we are pleased with how the potential value proposition of sparse symptom, and IGA nephropathy is resonating in our payer engagements.

Thinking about like initial uptake there are several elements that we are taking into consideration and one of them is the relative conservative nature of Nephrologist prescriber base.

Peter Heerma: There is a strong understanding of the utility of clinically meaningful reductions in poteneria, and IGA nephropathy, especially if they are introduced before significant progression of disease. The value proposition increases when combined with a comparable safety profile to current, treatment standards, such as ACE inhibitors and ARBs.

Peter Heerma: Lastly, from a supply perspective, we are already positioned to ensure product availability, for strong lungs.

Adaptation for new treatment that we have seen it with recent introductions in nephrology.

We know for example that they don't want to burden the.

Office older patients to obtain.

Challenges so.

One thing that we have that we have.

Four.

Experienced tools to navigate that.

We anticipate launching during the holiday season that requires certain challenges as well in the first full quarter that we will see first Boston is expected in the first quarter of 2023 and as usual also when the payers are.

Lisa mature.

So those are elements, we've taken into consideration, we do anticipate a strong uptake once physicians gain patient experience and make it a foundational therapy for their patients.

Patients. So I think the attractive profile of <unk>, we believe resonates well with patient needs together with our settled with an experienced commercial team gives me confidence that our mission to achieve.

Peter Heerma: Overall, we believe that the external feedback from patients, nephrologists, and patients, and payers, together with the internal strengths of our recently expanded commercial team, we will enable us to achieve our vision of making sparse symptom the foundational therapy for patients with IGA nephropathy, if approved.

Peter Heerma: The added time now between the two potential launches for sparse symptom will allow us, to be incredibly focused on the best start for IGA nephropathy and also apply these learnings and experiences from the IGA nephropathy launch to have a strong launch in FHDS in 2024, if approved.

Spar is foundational therapy is feasible unreachable.

Given what we have seen this other opex metrology in particular and given the timing of our launch that maybe look at the initial bolus that you were talking about but if we can foster update later on one space.

Physicians have experience with function.

Alright, thank you for that.

Yeah.

Sure.

Laura: I will now turn the call over to Laura for financial updates.

Thank you we will take the next question from line Maury Raycroft.

From Jefferies. Your line is open now please go ahead.

Laura: Laura?

Hi, good morning, Thanks for taking my questions and congrats I'll add my congrats to you Laura as well great working with you.

And.

The question I had is you mentioned the bar for FX, Yes is high.

Has that been a quantified what the threshold is for <unk> approval and lastly, you mentioned you continue to see for a sensitive consistently can you elaborate on what that means.

Laura: Thank you, Peter.

Laura: For the second quarter of 2022, we reported total revenue of $54.2 million, consisting, of approximately $51 million in net product sales and $3.2 million in collaboration revenue from our European collaboration with V4 Pharma.

Laura: This compares to $54.6 million in net product sales reported for the same period in 2021.

Sure. Good morning, Maury I'd say first I'll turn to bill to articulate what we understand that bar is for accelerated approval with <unk>. So I think it's important for us to.

Laura: As we typically see in the second quarter, growth to net discounts narrowed following, the insurance coverage changes that typically impact first quarter sales.

Laura: We reported a gap net loss of $67 million for the second quarter of 2022. After adjusting for non-cash expenses and income tax, we reported a non-gap net loss, of $41.3 million for the second quarter of 2022. On a gap basis, R&D expenses were $59.7 million for the second quarter of 2022. The increase compared to 2021 is largely attributable to increased headcount as well as medical, affairs activities to support the continued advancement of the Sparsentin and PEG-tobatinase programs.

Laura: On an adjusted basis, R&D expenses were $54.4 million for the second quarter of 2022. Net non-cash expenses for the fourth quarter included $5.3 million of stock-based compensation, and amortization.

Laura: On a gap basis, selling general and administrative expenses for the second quarter of 2022 were, $53 million. The increase compared to 2021 is largely attributable to increased headcount and commercial launch, preparation.

Laura: On an adjusted basis, SG&A expenses for the second quarter of 2022 were $37.5 million. Significant non-cash adjustments for the quarter consisted of $15.4 million in stock-based, compensation and depreciation and amortization.

Laura: From an operating expense perspective, we anticipate that our R&D expenses will increase, from current levels and it may be uneven quarter to quarter as we continue to invest in ongoing clinical work and long-term supply for both Sparsentin and PEG-tobatinase.

Laura: Consistent with our planning from the beginning of the year, we expect increases in SG&A from, second quarter levels as we now have the full field force staffed and continue to prepare for the potential Sparsentin launch in IgA nephropathy.

To really highlight what we've been saying historically around the differences between these two programs with regard to the disease. The trial design as well as the literature that supports that link in modeling that.

Laura: As we enter the second half of the year, we continue to be in a strong financial position, to execute. We ended the second quarter with $553.2 million in cash and cash equivalents. Notable one-time payments made during the second quarter consisted of an $8 million, milestone payment to Ligand for the NDA submission for IgA nephropathy. Importantly, we believe this cash balance can support our operations into 2024, which, takes into account potential further competitive pressure on Sciola, investing in Sparsentin launches for both IgA nephropathy and FSGS, as well as milestone payments we expect to pay related to regulatory achievements for Sparsentin and PEG-tobatinase.

Laura: As this will be my last call as CFO, I'd like to thank our incredible finance team and all, of you for your continued support and engagement over the last eight years.

Laura: The future at Trevere remains incredibly bright, and I look forward to working closely, with Chris and the rest of the management team through early next year to ensure a smooth transition.

Eric Dube: Let me now hand the call back over to Eric for his closing comments.

The link between Proteinuria and Egfr I'll ask Bill to take your first question and then I'll ask Julie to provide her perspective on.

Eric Dube: Eric?

Eric Dube: Thank you, Laura.

Eric Dube: Overall, we continue to execute towards our vision of being a leader in the global rare, disease community. We are doing this through the continued development of our pipeline with the objective of positioning, it for sustainable, diversified growth for years to come. And by strengthening our organization to support broad access to our medications and, meet the needs of patients as our products become available.

Eric Dube: We are entering the second half of the year, having made significant progress towards our, goal of Sparsantan becoming a new treatment standard for rare kidney disorders. The review process for our NDA for IJ nephropathy remains on track.

Eric Dube: And we are in great shape preparing the organization, and we will be fully ready to launch come, November if approved.

The profile of <unk> that we see consistently throughout the programs Bill.

Yes, certainly good morning, Maureen the FDA really hasnt set a specific threshold.

But we do believe that that bar is high.

Also in our discussions with them have recognized the difficulty in studying <unk> in particular have been very few studies done in this disease, there isn't an existing precedent and duplex is going to be the largest dataset in a controlled study in <unk> once we.

We completed early next year, but.

We don't have a specific numerical threshold.

The numerator to us I'll hand over to Julia for some of the additional color.

Yeah, I'll comment that what's reassuring to us is for attentiveness acting consistently and Marty have heard the proteinuria reduction that we've seen consistently across all the trials to date the consistent primarily of reduction we saw in duet in patients with FCS the consistent partner a reduction that we saw and protect in patients with <unk>.

Eric Dube: We now know that we will have to wait a bit longer for FSGS, but the fundamental value, and our confidence in Sparsantan has not changed. We believe it is a matter of difference in time, and we will put that to good use.

Eric Dube: While we are awaiting the results of the full two-year EGFR data from duplex, we will take, the opportunity to focus even more sharply on the launch of IJ nephropathy if approved and applying those learnings to commercialization of FSGS in the future if approved.

Eric Dube: Additionally, now with breakthrough therapy designation granted for PEG to BATNASE, we, believe we will be able to efficiently align with regulators on a pivotal program that will give us the best chance of success in delivering the potential first disease-modifying therapy to a community in need of new treatments.

Eric Dube: I would like to extend one final thank you to Laura for her incredible service and leadership, and also reiterate what she said earlier.

Eric Dube: The future is incredibly bright at Trevere, and I look forward to continued execution, through the balance of the year.

Chris Cline: Now let me turn the call over to Chris for Q&A.

Chris Cline: Thanks, Eric.

And in the duplex trial that we saw in patients with Fcs.

The consistency that we're referring to with regards to the Egfr profile, we can't released any data. Unfortunately in the protect and in the duplex trial, obviously the integrity of those trials that are ongoing but what we can refer back to is the historical data of duet and so we're only able to say.

Thats far suntan is acting consistent with what we've seen historically and what we saw historically with duet as we saw in acute decline in Egfr and then a stabilization of Egfr and that's what we see and that's the natural history that we see with car content and Thats. The mechanism of action that you would expect to see with the dual combination.

Of Endothelin and Ras blockade and that's what gives us the consistency that we see in the profile of <unk>, what you would anticipate to see.

Got it that's really helpful and maybe one quick follow up just.

Digging into the Fda's threshold.

Are they more focused on.

The <unk>.

Magnitude of Delta.

Brin control and treatment or are they more focused on what you see over the duration of treatment and so thats why they wanted to see if the two year data.

For FX, yes.

Bill will come back to you.

Yes, I think it's all of those things I think that.

Its effect size is variability it's the duration of effect, it's a consistency of the data picture presented by all the elements of the study proteinuria being a strong anchor on one end.

But then looking across all of the data that's available.

Recall that with accelerated approval, it's only a partial data set so they have less to go on.

It's not one specific element.

Got it. Thank you for taking my call I think.

Yes, more thank you for your question, but I think it's important to reiterate that we believe that ultimately we.

With that time, completing the two years, that's going to allow us to meet that bar for full approval in <unk> next year.

Got it okay. Thank you.

Yeah.

Operator: Caroline, can we please go ahead and open up the lines for Q&A?

Thank you we will take our next question from the line Joseph from SBB Securities. Your line is open. Please go ahead.

Operator: Thank you.

Thanks, very much and I'd like to also pass along my best wishes to Laura It was great to work with you.

I was just wondering if.

You guys could talk a little bit about.

The heterogeneity of the past year has some more in the context of the patients that have been enrolled in duplex. How representative of the overall population are these patients and are there any particular.

Market segments that.

Naturally present themselves and with some of these.

Be expected to be early versus later adopters of <unk> if approved.

Operator: To ask a question, please signal by pressing star 1 on your telephone keypad.

Joe Thanks for the questions.

I'll turn that one to you and then maybe Peter can can share a little bit of the thinking as we look to ultimately launch and what the patient population looks like July .

Operator: If you're using a speakerphone, please make sure your mute function is turned off to reach, our equipment.

Yeah. So I mean, <unk> is a heterogenous patient population.

Operator: Once again, please press star 1 to ask a question.

We enrolled a wide spectrum of patients with Fcs.

Operator: We will take the first question from the line, Team Lugo from William Blimp.

And I think Thats important to note and this is the largest trial of <unk> patients to date, and we enrolled primary FX jetson genetic patients with FCS and patients at risk for progression.

Operator: The line is open now.

Tim Lugo: Please go ahead.

And the spectrum included patients with a wide range of Egfr from 30 way above 90, with 20% of patients with Egfr above 90, so earlier in their disease state with regards to Egfr, but still at high risk for progression and Additionally, we enrolled a significant proportion of pediatric patients and I think that's really important.

Tim Lugo: Thank you for the question, and congratulations, Laura, on all your work over the past years.

No as filed with regards to the patient population that were represented.

And Ah.

Just a wide range of patients and then significantly at risk for progression I think that's an important thing to note as well.

Now I'll turn it over to Peter with regards to who we think we're going to be sitting here.

Yes, I think thanks for the question.

We have finished our segmentation for sufficient.

We're looking both at.

Prescribe a potential interim.

A lot of patients with <unk> as well as behavioral SA.

In in Iga nephropathy, what we see other than maybe in other rare diseases, where you have more central excellence. There is more a broader care concentration of care in the fall I think it's something we have talked about historically as well, but still we see when we look at the different <unk> there.

There's differences in the amount of patients that are seen by the Nephrologist and I think we have a good handle on that.

With our focus going to be as well and that allows us to be very focused initially with loans as well how we.

Our focus our efforts on sourcing centers and physicians throws at us.

That's very helpful. Thank you Peter So maybe I could add just a little bit more context for for your questions Joe because.

Tim Lugo: I wanted to just verify and be clear what two-year data from Duplex was the FDA able, to look at.

Because I think for folks that may not be as close to this space. It will be important to reiterate the first is I think with regard to.

Market uptake.

What we are hearing from Nephrologist is that based on the mechanism of action of <unk> and the unique mechanism of action and that common injury pathway.

Our strong belief amongst nephrologist that there would be broad use across the heterogeneous genius <unk> population and so we don't see that there's any particular kind of poll.

One way or another with regards to that segment. So we do believe that's a fundamental assumption behind our view that <unk> will be the foundational therapy for both <unk> and Iga nephropathy.

And I just wanted to spend a moment on what Joe had mentioned in the pediatric patients and why perhaps day, it's important to think about that in the context of the heterogeneity and in.

The duplex trial, maybe Julie you can speak a little bit about the Egfr profile. There typically we see in pediatric <unk> patients and why that may contribute to sort of where we are today with that trial.

Sure.

Yes, certainly.

When we think about the broad spectrum of patients that we represented in this trial. We did have patients who are very early in their disease and pediatric patients have really normal kidney function really in the high range of functioning well above 120.

Within the pathophysiology of FX, Yes, you really want to correct that down to normal and that's what you do when you give whether it's an endothelin antagonist of Ras blockade and so you want to correct that hyper filtration and Thats one of the common pathway injuries with FX, yes that you want to correct that.

Distinct from say Iga nephropathy.

Thank you very much.

Yeah.

Thank you we'll take the next question from Greg Harrison from Banco Corroborate that your line is open now. Please go ahead.

Good morning. This is.

How calling in for Greg Harrison, So just had a question about.

Hi.

The pharmacy.

Have you thought about pricing to value.

Maybe patient benefit when we finally get to kind of get a sense about your starting press Seth on maybe some of the factors that you would see the when determining the pricing.

Yes. Thank you Hao for the question, we have not disclosed how we will be pricing specifically.

Specifically, yet, but I will ask Peter to share a bit of his team's thinking as we prepare for the pricing at launch in Iga nephropathy.

And so you are hopeful that the question so yes.

Eric mentioned, we have.

Additionally, any any pricing and we won't do that prior to launch as well.

We have studied quite a bit on the burden of disease of Iga nephropathy to make an insightful for patients for payers like what are the costs associated with diseases.

And we know that the substantial given the progressive nature of the disease.

Lee.

Leading to end stage renal disease for many of those patients OSM being dialysis.

We've also been studying the value proposition for spar symptoms, we have disclosed some of the data.

What's the potential bill you could be off.

Reducing proteinuria was the level that we have seen with our response syndrome.

We have started engagement with payers as well and advisory boards as well as in field conversations.

I'm very pleased to see that there is good.

Understanding of proteinuria.

<unk> community.

And as.

As far as understanding as well what the value proposition was supposed to I think could be so I think that gives me confidence. So answering your question on the price that something to come but rather it always starts with like what is the potential that this product provides too.

Players in society, and Im pleased with the conversations we had.

Yes. Thank you better I think additionally, I can say how is that we do our strategy will be to price <unk> or broad access given our plan to make sports center and the new foundational therapy and so in order for us to achieve that vision, we need to make sure that we have.

Broad access and we are taking a lot of the great work that Peter's team is doing on modeling the health economic benefit as well as insight from payers.

And the early uptake in access for others within this space. So I think we'll be in a very strong position to achieve our vision was first sentence.

That's helpful. Thank you.

Thank you.

Thank you we'll take our next question from the line of <unk> problem.

From Barclays. Your line is open now please go ahead.

Great. Good morning, Thanks for taking the questions maybe just to switch it off for a second congrats on the pick <unk> breakthrough therapy designation.

Based on that what should we read through to kind of sort of growing alignment between you and FDA around the nature of that phase III program and when that might be able to get started and then.

Tim Lugo: I know you obviously had a little bit over half of the patients at two years, but I believe, you mentioned to preserve alpha, you did not run stats on these patients for proteinuria.

I'm sure you've called it out during the prepared remarks around that you Didnt performed stats on on the on the Egfr data going back as far as certain I guess I'm sure you guys consider that at some point and having gone through the discussion with the FDA do you think that would have helped assuage some of the fda's concerns here.

Tim Lugo: And also, I guess now that you're expecting to launch an IGAN with the steroid therapy, already on the market, can you talk a bit about, you know, are you expecting the initial patient bullets to start sparsantin and hopefully post-approval will be those that have already progressed on the progesterone therapy?

Eric Dube: Tim, good morning, and thanks for the questions.

Thoughts on that would be helpful.

William Rote: I'll ask Bill to take the first question on, what data was available for FDA, and then I'll ask Peter to talk about how we're thinking about the early uptake in IGAN once approved.

Thank you Carter Bill I'll ask you to take both of those.

William Rote: Good morning, Tim, and thanks for the question.

Yeah.

So for the.

Breakthrough designation that allows us to have.

Additional conversation with the agency. So once that's been granted the agency then provides a multidisciplinary meeting where we meet with the different groups of the different review divisions, and then that Spurs additional specific work.

William Rote: With our agreement with the agency, there was very little done with the EGFR data, and, that was a deliberate strategy to preserve the alpha for the study, so what we provided was a descriptive look at the composite of all available EGFR data for the sparsanthin arm and the herbicartin treatment arm, so it wasn't broken out specifically based on with those that were at two years versus those that were at one year. It was combined together, and they looked at the aggregate of that EGFR data plot, if that helps you, but it wasn't divided into specific groups based on duration in the study.

William Rote: Okay, that's helpful.

William Rote: Thank you.

Peter Heerma: And for the launch...

Peter Heerma: Thank you, Tim, for your question.

On different elements of the development path, it's essentially designed such that baseline around to your side of the table and help you with the development moving forward.

For us what that means is that we are working currently on definition of <unk>.

Surrogate endpoint and that will continue.

And then working with them on.

Phase III trial design, what the specific data elements need to be and should be how the pediatric.

Patients should be included in that development as well as aspects of manufacturing.

And progression of that side of it.

It's an iterative process moving forward, so we really need to get through a few of those steps before I can give you better.

Sure.

Vision, two to where we're starting on the phase III study and when we can.

Some of those will be back with with greater specificity on that and I was I'm sorry, I was writing notes for the for that question as you ask your second one could cause that'd be rephrased, Colombia. Please.

Peter Heerma: Shall I answer the question on your, bullet, or did you have an additional question for Bill?

Tim Lugo: Oh, no, I was hoping to hear from you, Peter, on the launch versus, you know, the initial bullet for patients, where do you expect that they, will be kind of steroidally deaf and hard, or other steroids?

Sure It was.

I'm sure there was cost that you mentioned.

There were no stats performed in the Egfr data consistent with prior messaging I'm sure. There was consideration of doing some additional.

We'll work on that data over various points in the past past year and having gone through the discussions with FDA do you think that.

Do you think having done that or being able to deliver some additional data on that front would have helped to switch some of their concerns.

Yeah.

Yes.

That's a tough one to answer I'm not sure if it would or wouldn't have for us. The key was preserving alpha for the endpoints of this study we wanted to to maintain our highest probability of success at the confirmatory endpoint.

That is the primary goal so we really.

Made the decision to do it that way in order to ensure our best chance of <unk>.

Delivering this for <unk> patients.

Thank you.

Peter Heerma: Excellent.

Thank you we will take our next question is from the line Laura.

Jacob.

Right.

Peter Heerma: Thanks for that, Tim.

Peter Heerma: Thinking about, like, initial uptake, there are several elements that we are taking into, consideration, and one of them is the relative conservative nature of nephrologists as a prescriber based in their adaptation for new treatment, and we have seen it with recent introductions in nephrology.

Good morning, Thanks, very much for taking the question just for clarification I'm wondering if you could just.

Peter Heerma: We know, for example, that they don't want to burden their office or their patients to obtain challenges, so that's something that we have plenty for, and we have the experience to navigate that.

Comment on steady retention in both duplex and protect I guess have discontinuation.

Progressed as anticipated in both of these studies now that we've had interim updates and then a follow up I just wanted to clarify so the mid cycle review meeting has completed with respect to Iran.

And obviously the agency has seen the interim <unk> data from duplex, but I'm wondering if the <unk> data could somehow trigger an amendment or how that might impact. The IGON review I just wanted to clarify there. Thanks.

Laura Thank you for your questions Joe what can you. Please.

Take the question on study retention in duplex and protect.

Yes.

Yeah.

High quality.

I apologize for that.

So you can continue to progress with very high quality and we're seeing dropout rates within the range of what you would expect for Nephrology studies of this link and we as you can imagine have quite a significant amount of effort to make sure that we maintain the patients.

In both studies and so we're very proud of the efforts that we've put into this and with the retention rates that we're seeing today.

And Bill would you like to take the question on the mid cycle review.

The data availability and how that might impact the Fda's review.

Certainly.

The FDA throughout our development program is consistently pointed to evaluating these two programs independently and this remains the case, they're different diseases. They are studied on their own and they have trial designs that are different and there are key differences between them that we have.

Highlighted.

Did have the.

The datasets envision to both programs the whole way through so at the point of their mid cycle review meeting they were aware of the duplex.

And there was no expression of concern on their part.

As a result of those the duplex data.

It was in that frame that they gave us very clear.

Clear feedback and that we were on track that there was no plan for an AD com was reiterated.

And we are looking forward to our action date in November .

Thanks very much.

Thank you we will take our last question from the line Edward Nash from Canaccord. Your line is open. Please go ahead.

Hi, Thanks, guys for taking my question and really appreciate the clarity on the <unk>.

Here in the state.

And in Europe , I guess my question, just a specific to Europe , but we'd just be.

Clearly, it's the risk averse to position to kind of wait for European filing also on <unk>.

But just wanted to know.

Do you guys feel confident that it will probably turn out the same way with Europe . If you went ahead and did the combined filing that the Europeans would also view.

The same issue and see that increased heterogeneity would required to see data out to two years.

Or is it also just by filing together.

It would risk the <unk>.

Again approval there if you have both going on at the same time.

Hey, Thanks for the question I'll turn that one over to bill.

Sure.

Ultimately our commitment here is to get <unk> to patients fast as fast as possible and that remains unchanged.

While we believe there is a case to be made to putting the two together in combination we felt that that would be adding a potential incremental risk to the probability of an IGN approval and therefore, risking our ability to deliver spartan sense into those patients as quickly as possible.

Sure.

EMEA where to end up with the same view as the FDA.

We're now strategically aligning with our partners before on the regulatory process. So that we have the best probability of success for both applications in Europe , and we look forward to getting the first potential approval and again next year.

Peter Heerma: But as we anticipate in launching during holiday season, that requires certain challenges as well, and the first full quality that we will see for sparsant and is expected in the first quarter of 2023, and that's usually also when the payers are resetting the insurance plan.

Great. Thanks, so much I appreciate it.

Terminal Thanks, Ed.

Yeah.

Thank you and there is no further question at this time.

Great well. Thank you everybody for joining us this morning for all of our updates.

Peter Heerma: So, those are elements we take into consideration.

Peter Heerma: We do anticipate a strong uptake once physicians gain patient experience and make it a foundational therapy for their patients.

Have an exciting second half of the year ahead, and we look forward to sharing more updates along the way have a great rest of the day.

Peter Heerma: So, I think the attractive profile of sparsant that we believe resonates well with patient needs, together with our talented and experienced commercial team, gives me confidence that our mission to achieve sparsant as a foundational therapy is feasible and reachable.

Peter Heerma: But I think, given what we have seen with other uptakes in nephrology in particular, and given the timing of our launch, there may be not the initial bonus that you're talking about, but I think a faster uptake later on once physicians have experience with sparsant.

Peter Heerma: All right.

Peter Heerma: Thank you for that.

Peter Heerma: Thank you.

Operator: We will take the next question from line Maurie Raycroft from Jeffrey.

This concludes today's call. Thank you for your participation you may now disconnect.

Okay.

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Operator: The line is, open now, please.

Maurice Raycroft: Hi, good morning.

Maurice Raycroft: Thanks for taking my questions and congrats.

Maurice Raycroft: I'll add my congrats to you, Laura, as well.

Maurice Raycroft: Great working with you.

Maurice Raycroft: And the question I had is you mentioned the bar for FSGS is high.

Maurice Raycroft: Has FDA quantified what the threshold is for FSGS approval?

Maurice Raycroft: And lastly, you mentioned you continue to see Spartan Sentinel-X consistently.

Maurice Raycroft: Can you elaborate on what that means?

Maurice Raycroft: Good morning, Maury.

Eric Dube: Sure.

Eric Dube: I'd say first I'll turn to Bill to articulate what we understand that bar is for accelerated approval with FSGS.

William Rote: I think it's important for us to really highlight what we've been saying historically around the differences between these two programs with regard to the disease, the trial design, as well as the literature that supports that link in modeling the link between proteinuria and EGFR.

Eric Dube: I'll let Bill take your first question, and then I'll ask Jula to provide her perspective, on that profile of Spartan Sentinel-X that we see consistently throughout the programs.

William Rote: Bill?

William Rote: Yeah, certainly.

William Rote: Good morning, Maury.

William Rote: The FDA really hasn't set a specific threshold, but we do believe that that bar is high. They also, in our discussions with them, have recognized the difficulty in studying FSGS in particular.

William Rote: There have been very few studies done in this disease.

William Rote: There isn't an existing precedent, and duplex is going to be, you know, the largest data set in a controlled study in FSGS once we complete it early next year.

William Rote: But we don't have a specific numerical threshold that they've enumerated to us.

William Rote: I'll hand over to Jula for some of the additional color.

Jula Inrig: Yeah, I'll comment that what's reassuring to us is Spartan Sentinel-X is acting consistently, and you, Maury, have heard the proteinuria reduction that we've seen consistently across all the trials to date, the consistent proteinuria reduction we saw in duet in patients with FSGS, the consistent proteinuria reduction we saw in PROTECT in patients with IgA nephropathy, and in the duplex trial that we saw in patients with FSGS.

Maurice Raycroft: And I think, you know, yeah, Maurice, thank you for your questions.

Jula Inrig: The consistency that we're referring to with regards to the EGFR profile, we can't release any data, unfortunately, in the PROTECT and in the duplex trial.

Eric Dube: And I think it's important, to reiterate that, you know, we believe that ultimately with that time completing the two years, that's going to allow us to meet that bar for full approval in an SNBA next year.

Jula Inrig: Obviously, the integrity of those trials, as they're ongoing, but what we can refer back to is the historical data of duet.

Maurice Raycroft: Got it.

Jula Inrig: We're only able to say that Spartan Sentinel-X is acting consistent with what we've seen historically.

Maurice Raycroft: Okay.

Jula Inrig: What we saw historically with duet is we saw an acute decline in EGFR, and then a stabilization of EGFR.

Maurice Raycroft: Thank you.

Jula Inrig: That's what we see, and that's the natural history that we see with Spartan Sentinel-X, and that's the mechanism of action that you would expect to see with the dual combination of endothelin and RAS blockade.

Maurice Raycroft: Thank you.

Operator: We will take our next question from the line, Joseph, from, SBB Securities.

Jula Inrig: That's what gives us the consistency that we see in the profile of Spartan Sentinel-X and what you would anticipate to see.

Maurice Raycroft: Got it.

Jula Inrig: That's really helpful.

Maurice Raycroft: Maybe one quick follow-up.

Maurice Raycroft: Just digging into the FDA's threshold, are they more focused on the magnitude of delta between control and treatment, or are they more focused on what you see over the duration of treatment, and so that's why they want to see the two-year data for FSGS?

Operator: The line is open now.

William Rote: Bill, I'll turn that to you.

Joseph Schwartz: Please go ahead.

William Rote: Yeah, I think it's all of those things.

Joseph Schwartz: Thanks very much.

William Rote: I think that, you know, it's effect size, it's variability, it's the duration of effect, it's a consistency of a data picture presented by all the elements of the study, proteinuria being a strong anchor on one end, but then looking across all of the data that's available.

Joseph Schwartz: And I'd like to also pass on my best wishes to Laura.

William Rote: You know, recall that with accelerated approval, it's only a partial data set, so they have less to go on, but it's not one specific element.

Maurice Raycroft: Got it.

Joseph Schwartz: It was great to, work with you.

Maurice Raycroft: Thank you for taking my question.

Joseph Schwartz: I was wondering if you guys could talk a little bit about the heterogeneity of FSGS some more in the context of the patients that have been enrolled in duplex.

Joseph Schwartz: How representative of the overall population are these patients, and are there any particular market segments that naturally present themselves?

Joseph Schwartz: And would some of these be expected to be early versus later adopters of SPARS intent if approved?

Eric Dube: Joe, thanks for the questions.

Jula Inrig: Jule, I'll turn that one to you, and then maybe Peter can share, a little bit of the thinking as we look to ultimately the launch and what the patient population looks like.

Operator: The line is open now.

Jula Inrig: Jule?

Operator: Please go ahead.

Jula Inrig: Yeah.

Hao: Good morning.

Jula Inrig: So, I mean, FSGS is a heterogeneous patient population, and we enrolled a wide spectrum of patients with FSGS, and I think that's important to note.

Hao: This is Hao calling in for Greg Harrison.

Jula Inrig: And, you know, this is the largest trial of FSGS patients to date, and we enrolled primary FSGS and genetic patients with FSGS, and patients at risk for progression. And the spectrum included patients with a wide range of EGFR from 30, way above 90, with 20% of patients with EGFR above 90, so earlier in their disease state with regards to EGFR, but still at high risk for progression.

Hao: So I just have a question about the IgA nephropathy.

Jula Inrig: And additionally, we enrolled a significant proportion of pediatric patients, and I think that's really important to note as well with regards to the patient population that we're represented.

Hao: Have you thought about pricing to balance maybe patient benefit with value, just to kind of get a sense about your sorting process and maybe some of the factors that you would consider when determining the pricing?

Operator: Maybe just to switch it up for a, second, congrats on the pegabatinase breakthrough therapy designation.

Jula Inrig: And so, just a wide range of patients, and then significantly at risk for progression, and I think that's an important thing to note as well.

Eric Dube: Yes, thank you, Hal, for the question.

Operator: I guess, based on that, what should we read through to kind of, you know, sort of growing alignment between you and FDA around the nature of that phase three program and when that might be able to get started?

Jula Inrig: And I'll turn it over to Peter with regards to who we think we're going to be studying here.

Eric Dube: We have not disclosed how we will be pricing, specifically yet, but I will ask Peter to share a bit of his team's thinking as we prepare for the pricing and launch of iGeneaphropathy.

Operator: And then, you know, you called it out during the prepared remarks around that you didn't perform stats on the EGFR data by going back to sparse intone.

Peter Heerma: Yeah, thank you.

Peter Heerma: Indeed, and thank you, Hal, for that question.

Operator: I guess, I'm sure you guys, you know, consider that at some point.

Peter Heerma: Thanks for that question.

Peter Heerma: Yeah, indeed.

Operator: And having gone through the discussion with FDA, do you think that would have helped assuage some of FDA's concerns here?

Peter Heerma: I mean, we have finished our segmentation for physicians, and we're looking both at prescribable potential in amount of patient attack screening, as well as behavioral aspects.

Peter Heerma: Eric mentioned we have not disclosed any pricing yet. We will do that prior to launch, as well.

Operator: Any thoughts on that would be helpful.

Peter Heerma: In IgA nephropathy, what we see, other than maybe in other rare diseases where you have, more central excellence, there is more a broader care, concentration of care in nephrology.

Peter Heerma: We have studied quite a bit on the burden of disease of iGeneaphropathy to make it insightful for payers, like what the cost associated with disease is today. And we know that's substantial given the progressive nature of the disease and ultimately leading to end-stage renal disease for many of those patients, often being dialysis.

Operator: Thank you, Carter.

Peter Heerma: I think it's something we have talked about historically as well.

Peter Heerma: We've also been studying the value proposition for sparse intone.

William Rote: Bill, I'll ask you to take both of those.

Peter Heerma: But still we see, when we look at the different death files, there is differences in amount, of patients that are seen by the nephrologist.

Peter Heerma: And we have disclosed some of that data earlier on, what the potential value could be of reducing proteinuria with the level that we have seen with sparse intone.

William Rote: So, for the breakthrough designation, that allows us to have additional conversation, with the agency. So once that's been granted, the agency then provides a multidisciplinary meeting where, we meet with the different groups of the different review divisions, and then that spurs additional specific work on different elements of the development path.

Peter Heerma: I think we have a good handle on that, that our focus is going to be as well, and that, allows us to be very focused.

Peter Heerma: And we have started engagement with payers as well in advisory boards as well as in field conversations.

William Rote: It's essentially designed such that they slide around to your side of the table and, help you with the development moving forward.

Peter Heerma: And initially was launched as well, how we focus our efforts on certain centers and positions, versus others.

Peter Heerma: And I'm very pleased to see that there is a good understanding of proteinuria amongst the payer community.

William Rote: For us, what that means is that we're working currently on definition of surrogate endpoint, and that will continue, and then working then with them on phase three trial design, what the specific data elements need to be and should be, how the pediatric patients should be included in that development, as well as aspects of manufacturing and progression of that side of it.

Peter Heerma: It's very helpful.

Peter Heerma: And there's a solid understanding as well what the value proposition of sparse intone could be.

William Rote: It's an iterative process moving forward, so we really need to get through a few of, those steps before I can give you better vision to where we're starting on the phase three study.

Peter Heerma: Thank you, Peter.

Peter Heerma: So I think that gives me confidence.

William Rote: And when we've completed some of those, we'll be back with greater specificity on that.

Peter Heerma: Thank you, folks.

Peter Heerma: It's not answering your question on the price.

William Rote: And I'm sorry, I was writing notes for that question as you asked your second one.

Eric Dube: And maybe I can add just a little bit more context for your questions, Joe, because I, think for folks that may not be as close to this space, it'll be important to reiterate.

Peter Heerma: That's something to come.

Eric Dube: The first is, I think, with regard to market uptake, what we are hearing from nephrologists, is that based on the mechanism of action of sparsantin and the unique mechanism of action and that common injury pathway, there is a strong belief amongst nephrologists that there would be broad use across the heterogeneous FSGS population.

Peter Heerma: But rather than price, it always starts with, like, what is the potential value that this product provides to payers and society?

Eric Dube: And so we don't see that there is any particular kind of pull one way or another with regard, to that segment.

Peter Heerma: And I'm pleased with the conversation we're having on that.

Eric Dube: So we do believe that's a fundamental assumption behind our view that sparsantin will be the, foundational therapy for both FSGS and IgA nephropathy.

Peter Heerma: Yeah, thank you, Peter.

Eric Dube: And I just want to spend a moment on what Julie mentioned in the pediatric patients, and why perhaps it's important to think about that in the context of the heterogeneity and in the duplex trial.

Eric Dube: What I think, additionally I can say is that our strategy will be to price sparse intone for broad access, given our plan to make sparse intone the new foundational therapy.

Jula Inrig: Maybe, Julie, you can speak a little bit about the EGFR profile that typically, you, know, we see in pediatric FSGS patients and why that may contribute to sort of where we are today with that trial.

Eric Dube: And so in order for us to achieve that vision, we need to make sure that we have broad access.

Jula Inrig: Yeah, certainly.

Eric Dube: And we are taking a lot of the great work that Peter's team is doing on modeling the health economic benefit, as well as insight from payers, and the early uptake and access for others within this space.

Jula Inrig: You know, when we think about the broad spectrum of patients that we represented in this trial, we did have patients who were very early in their disease.

Eric Dube: And I think we'll be in a very strong position to achieve our vision with sparse intone.

Jula Inrig: And pediatric patients have really normal kidney function, really in the high range, of functioning, well above 120.

Hao: That's helpful.

Jula Inrig: And within the pathophysiology of FSGS, you really want to correct that down to normal.

Hao: Thank you.

Jula Inrig: And that's what you do when you give, whether it's an endothelial antagonist, a RAS blockade.

Hao: Thank you.

Jula Inrig: And so you want to correct that hyperfiltration.

Operator: Thank you.

Jula Inrig: And that's one of the common pathway injuries with FSGS that you want to correct.

Operator: We will take our next question from the line.

Jula Inrig: And that's distinct from, say, IgA nephropathy.

Operator: The line is open now.

Jula Inrig: Thank you very much.

Operator: Please go ahead.

Jula Inrig: Thank you.

Operator: Great.

Operator: We will take the next question from Greg Harrison from Bank of America.

Operator: Good morning.

Operator: Thanks for taking the questions.