GUTS

Good afternoon, and welcome to Fractyl Health First Quarter 2026 Financial Results and Business Update Call. As a reminder, this conference call is being recorded. At this time, all participants are listen only mode. There will be a Q&A session following management's prepared remarks. I'll now turn the call over to Brian Luque, Head of Investor Relations and Corporate Development at Fractyl. Brian, you may now begin.

Thank you. This afternoon we issued a press release that outlines the topics we plan to discuss today. This release is available at www.fractyl.com under the Investors tab. Joining us on the call today are Dr. Harith Rajagopalan, Chief Executive Officer, and Lara Smith Weber, Chief Financial Officer. During this call, we make forward-looking statements which involve risks and uncertainties that may cause our actual results to differ materially from those expressed or implied by forward-looking statements. A discussion of these risks and uncertainties is included in our filing with the SEC from time to time, including the section titled Risk Factors in our annual report on Form 10-K for the year ended December 31, 2025, and our quarterly report on Form 10-Q filed today, which I encourage you to review.

Any forward-looking statements on the call are subject to substantial risks and uncertainties, speak only as of the call's original date. We undertake no obligation to update or revise any of the statements, even if subsequent events cause our views to change. It is now my pleasure to pass the call over to Harith.

Thank you, Brian. Good afternoon, everyone. Tens of millions of Americans are now on GLP-1 therapy. Over 1 million people are discontinuing GLP-1s each month in the U.S. What happens next is increasingly well-characterized. Weight regain of roughly 10% of total body weight in the first six months and 15% total body weight by 12 months. Every one of those patients stopping a GLP-1 faces a moment with no durable off-ramp, no alternative to either resuming chronic pharmacotherapy or accepting the risk of the return of the weight they've worked so hard to lose. The more weight lost on GLP-1s, the greater the risk of rapid weight and metabolic rebound upon discontinuation. Revita is being built for that moment. On our Q4 earnings call in March, we made four commitments to this audience.

First, we said that the signal is real, and we understand with greater clarity how Revita works and in whom it works best. Second, we said that the pivotal trial is fully randomized, built to succeed, and executing on plan. Third, we said the path from clinical data to commercial value is clear and that we are actively building it. Fourth, we said that we have the financial runway to reach pivotal data without a planned capital raise and that we intend to hold that line. Q1 2026 was a quarter of execution, and today I want to reaffirm these four commitments and give you a clear accounting on each of them. Let me take them each in turn. First, the clinical signal is real. The medical community sees it and appreciates its potential.

In March, we shared two findings from our REMAIN-1 midpoint cohort study that formed the clinical foundation for the pivotal study. A larger treatment effect in participants with higher run-in GLP-1 induced weight loss and a statistically significant dose-dependent treatment effect tied to duodenal ablation length, the right dose in the right patients. In early May, we presented the REMAIN-1 midpoint cohort six-month data at Digestive Disease Week, or DDW, which is the largest international meeting in gastroenterology, hepatology, and endoscopy. DDW is jointly sponsored by four major medical societies and showcases more than 6,000 abstracts on the latest advances in GI research, medicine, and technology. Ahead of this year's meeting, the DDW program committee selected the REMAIN-1 midpoint cohort for its press program, one of only four studies featured from those 6,000+ accepted abstracts.

This was the first time the dose response analysis and patient selection findings were presented in a peer-reviewed setting to a broad and expert clinical audience. During the meeting, we convened a clinical advisory board with leading gastroenterologists and metabolic medicine physicians from across the country, and the discussions confirmed their alignment on the mechanism, the procedural rationale, and our pivotal study design. Beyond the science, these are the clinicians who, in our view, are best positioned to lead a center of excellence model in bariatric and metabolic endoscopy, pending potential FDA approval of Revita. We already have a strong network of champion physicians who have been part of our clinical trial program over the years, and we are cultivating even more relationships now in parallel with the pivotal study.

The enthusiasm among the physician community for a new therapeutic option in metabolic endoscopy, and in particular for a solution for post GLP-1 weight rebound, is real, palpable, and growing. When management tells you the clinical signal is real, that is our conviction. When the clinical community at the world's largest GI meeting chooses your study for more than 6,000 abstracts as one of the four most newsworthy and engages with the data on its scientific merits, that is external validation. When we begin lining up the clinical leaders who would deliver this therapy if and when it reaches the market, that is preparation. We have all three: conviction, scientific validation, and clinical champions.

Point number two, the pivotal is executing on plan. Not only does the clinical community appreciate that the Revita clinical signal is real and growing, the REMAIN-1 pivotal cohort completed randomizations in February with more than 300 participants across more than 30 sites across the United States. It's the largest sham-controlled GI endoscopy pivotal trial ever conducted. Every operational metric that predicts pivotal success continues to track favorably. Let's turn to the analytical framework for the pivotal cohort. We have two pre-specified co-primary endpoints. The first measures the percent total body weight regain at six months in Revita participants versus sham after the discontinuation of tirzepatide. This is the endpoint that anchors our early Q4 readout. As I noted earlier, the published trajectory in patients who discontinued GLP-1 therapy is to expect roughly 10% total body weight regain by six months.

Against that benchmark, a meaningful statistically significant reduction in regain in the Revita arm versus sham, particularly in participants with longer ablation lengths or higher run-in weight loss, is what we believe a successful readout looks like. The second co-primary endpoint is a responder rate at 52 weeks, defined as a percentage of Revita-treated participants who maintain at least 5% total body weight loss from pre-tirzepatide levels through one year. Together, these endpoints test both the magnitude and the durability of the Revita treatment effect. Alongside the co-primaries, we will also evaluate the high run-in weight loss patient selection and dose response as key secondary endpoints that emerged from the midpoint cohort data analysis. Participant retention in the pivotal study continues to exceed well over 90%. Medication resumption rates remain below our modeled assumptions.

The blinded adverse event profile remains consistently reassuring and in line with what we've seen in our prior studies. The study is running as planned. We remain on track as well to deliver top-line six-month primary endpoint data in early Q4 2026. The countdown to last patient six-month visit in Q3 is clear and well-defined. On regulatory progress, we previously reported in March favorable FDA feedback on our De Novo classification request, confirming our review that Revita's safety profile is consistent with a moderate risk rather than a high-risk device classification. I'm pleased to reaffirm that we are on track for FDA submission in late Q4 2026 with our six-month pivotal data in-hand. Number three, we are actively building the commercial path. The underlying commercial opportunity has only continued to accelerate since we last spoke to you.

In early April, FDA approved Foundayo, the first once-daily oral GLP-1 for chronic weight management. This is a meaningful development in its own right and a concrete accelerator of the population that will eventually face post GLP-1 weight regain. While the advent of oral GLP-1s provides more options for patients, early data suggests that patients are not titrating their oral GLP-1s or refilling them at the expected rates, indicating that the need for a durable alternative will likely still be very large, even though the number of GLP-1 initiators only continues to grow. These market dynamics are favorable for Revita's position in the market. On the payer side, public programs are moving to expand low-cost access to GLP-1 therapies for Medicare and Medicaid beneficiaries. The specific policy mechanics for GLP-1 coverage are still being worked out, but the underlying direction is unmistakable.

Seniors, a population with among the highest obesity prevalence and among the highest risk of GLP-1 discontinuation, will have meaningfully expanded access to these therapies over the next 18 months. That matters for Revita for a simple reason. Every additional patient who starts a GLP-1 is another patient who will eventually face the question of what to do when that drug is discontinued. As public payers take on more of the cost of chronic GLP-1 therapy, the economic case for a durable, long time alternative gets sharper. Remember, approximately 1 million patients per month are discontinuing GLP-1s and needing a safe and effective off-ramp. The problem of post GLP-1 weight rebound turns a chronic heterogeneous disease like obesity into an acute problem that mandates an acute solution. Today, the only options are to continue chronic pharmacotherapy or accept the risk of rebound. Revita is being built to be the third answer at that moment of decision.

One additional development from the past few weeks deserves special mention as well. In late April, CMS and FDA jointly announced the RAPID coverage pathway designed to align Medicare national coverage with FDA market authorization for eligible breakthrough devices. Under RAPID, CMS issues a proposed national coverage determination on the same day a device receives FDA authorization, with full national coverage and payment potentially in place within approximately two months. We believe Revita may be well-positioned to benefit from this pathway. Revita holds FDA breakthrough device designation in both weight maintenance after GLP-1 discontinuation and Type 2 diabetes. Our REMAIN-1 pivotal study is an FDA-approved IDE trial measuring clinically meaningful outcomes that we believe are relevant to both FDA review and Medicare coverage. We have a track record of CMS collaboration.

Our prior Revita IDE studies in Type 2 diabetes received Medicare coverage of routine costs and study-related expenses. RAPID builds on that foundation. The pathway is still early in implementation, and we are continuing to work through the specifics with our reimbursement experts. Our initial read is that RAPID materially de-risks and potentially accelerates the commercialization reimbursement timeline for Revita should we reach the market. Beyond RAPID, our broader reimbursement infrastructure continues to advance on schedule. We remain on track to file a Category III CPT code application this summer with a code that would be expected to be effective in the summer of 2027. Transitional passthrough payment from CMS continues to provide a clear, positive pathway to a favorable contribution margin for hospitals should Revita reach the market.

One lesson we are learning from physicians at DDW is that this transitional passthrough payment mechanism has been successfully used in GI endoscopy by centers across the country, presenting a compelling option for Revita centers of excellence to be able to secure payment soon after launch. To our knowledge, Revita remains the only potential procedural therapy in development for post GLP-1 weight maintenance. Certainly, it's the only potential post GLP-1 weight maintenance option with pivotal trial data expected within six months. Turning briefly to Rejuva, our smart GLP-1 gene therapy platform targeting long-term metabolic remission from a single dose. We recently received authorization from EU regulatory authorities in the Netherlands to initiate the phase I/II first in human study of the RJVA-001 drug candidate, the first clinical candidate from our Rejuva platform.

With this authorization, we believe RJVA-001 is the first AAV-based gene therapy candidate to enter clinical development for Type 2 diabetes, and Fractyl now advances Rejuva to a clinical stage, just as Revita is potentially poised to exit clinical stage and graduate to commercial stage over the coming quarters. RJVA-001 is a one-time beta cell-targeted gene therapy designed to enable nutrient-responsive physiologic GLP-1 expression within the pancreas, potentially avoiding the high circulating drug levels that contribute to side effects seen with systemic GLP-1 therapy. The therapy is delivered via a minimally invasive endoscopic ultrasound-guided infusion directly into the pancreas, and this authorization reflects years of rigorous translational work, deep engagement with regulators, and a disciplined tissue-targeted approach to local AAV gene therapy that we believe differentiates RJVA-001.

We also plan to conduct the study at other sites in Europe and in Australia, where a clinical trial application has also been submitted. Regulatory feedback for Australia is expected in the third quarter of this year. Pending site activation, we expect to dose the first patient with RJVA-001 and report preliminary data in the second half of 2026. As a deliberate part of our capital allocation strategy, Rejuva clinical development is funded within our existing cash runway into early 2027, beyond the anticipated REMAIN-1 pivotal data readout, and there is no change to our capital plans.

Before I turn to Lara, I want to spend a moment on what the next several months look like. Three Revita data readouts lie ahead between now and year-end. The first two will provide specific incremental signals about what the pivotal cohort is likely to show, and the third is the pivotal data itself. Before I walk through each, let me be specific about what a good result looks like because we get that question often. The published literature predicts that patients who have lost approximately 20% total body weight on GLP-1s and then stop that medicine regain approximately 15% of their total body weight within a year. Against that benchmark, we would view roughly a 50% reduction in weight regain or 7.5% or less as a strong 12-month result in these studies for patients, clinicians, regulators, payers, and investors alike.

Based on the dose response and patient selection findings we have already described, we would expect the signal to be even stronger in participants with higher run-in weight loss and longer ablation lengths. The pilot sham control data provide visibility into the right dose and the right patients, and the upcoming clinical milestones offer the opportunity to bear that thesis out. Investors have also asked whether we intend to present these upcoming data sets through the same dose response and run-in weight loss lenses we used at Q4 earnings. The answer is yes. The biology has not changed, and neither has our view of how to interpret the data.

In Q2, we will see one-year data from the REVEAL-1 cohort, our open-label study. REVEAL-1 enrolled a population with broadly varied run-in GLP-1 exposure and significant weight loss, representative of the variation we would expect to see in a real-world GLP-1 discontinuer population. 12-month data from this cohort is our first look at how durable the Revita treatment effect is after a full year of GLP-1 therapy. It will not on its own settle the durability question, but it is a critical important first read on the shape of the curve. Remember that REVEAL-1 patients lost more than 20% total body weight on GLP-1 over more than a year on medicine, and we would expect a regain of about 15% at one year in those who discontinue. We look forward to seeing what the data from REVEAL-1 cohort teach us. The second major data catalyst is in Q3, 12-month randomized sham control data from the REMAIN-1 midpoint cohort.

This is the same cohort in which we shared our six-month randomized data, now with six additional months of follow-up under a blinded randomized sham-controlled design. At six months, we observed a compounding monotonically increasing separation between Revita and sham in the optimized patient population. If that trajectory continues, 12-month randomized data will potentially show a durable treatment effect in the same cohort over a period of time that regulatory guidance equates to durability of therapeutic effect. The third major data catalyst is the pivotal itself, with top-line six-month data expected in early Q4. By the time this readout arrives, investors will have seen two prior data points through 12 months that provide the opportunity to build conviction leading into the definitive pivotal readout. We believe this is a potentially rich and systematic catalyst setup up into the year-end and potential regulatory filing.

With 12-month data from the REVEAL-1 and the midpoint cohort and top line six-month data from the pivotal cohort, the entire clinical profile for Revita in post GLP-1 weight maintenance has the potential to be substantially clarified and defined by Q4 of this year. Layer on top of this clinical profile, the favorable feedback we've already received on our device classification, the breakthrough device designation in GLP-1 weight maintenance, the streamlined reimbursement pathway just announced by CMS, and the vocal support of clinical champions in GI endoscopy, we believe we are set up for an exciting upcoming set of quarters. Catalyst summary. In Q2, the DDW presentations are now complete. RJVA-001 CTA regulatory feedback has been received, we will soon see REVEAL-1 12-month open label data. Q3, REMAIN-1 midpoint cohort 12-month randomized sham control data.

Early Q4, top line six-month randomized data from the REMAIN-1 pivotal cohort. Late Q4, potential De Novo marketing application submission for Revita in post GLP-1 weight maintenance. In parallel, in H2, we expect to see first-in-human dosing of RJVA-001 and reporting of preliminary data subject to first site activation for Rejuva. Lara?

Thank you, Harith. Research and development expenses were $15.6 million for Q1 2026 compared to $19.4 million for the same period in 2025. The decrease was primarily related to reduced spending on our Revita and Rejuva programs, as well as lower personnel-related expenses. SG&A was stable, coming in at $5.2 million for Q1 2026 compared to $5.3 million for the same period in 2025. We reported net income of $9.2 million for Q1 2026 compared to a net loss of $23.7 million for the same period in 2025. The shift was driven by a $30.1 million non-cash accounting change in the fair value of our warrant liabilities, which does not reflect a change in our underlying operating performance.

Our total operating expenses for Q1 2026 were $3.9 million lower than the same period in 2025. Adjusted EBITDA was negative $18 million for Q1 2026, compared with negative $23 million in Q1 of 2025. The decrease was primarily due to a decrease in operating expenses. As of March 31, 2026, we had approximately $63.2 million in cash and cash equivalents. Q1 spend included certain one-off costs, primarily associated with completing REMAIN-1 pivotal cohort randomization and is not representative of our expected run rate for the remainder of the year. Based on current business plans, this cash position is expected to fund operations into early 2027 beyond anticipated REMAIN-1 pivotal data readout in early Q4 2026 and through a potential De Novo submission in late Q4 2026.

With that, I'll turn it back to Harith.

Thank you, Lara. Before we open Q&A, I want to reaffirm our capital posture without ambiguity. Our ATM facility remains closed. We do not plan to raise capital before we have pivotal data in-hand. Our runway extends into early 2027. This posture is a deliberate choice grounded in conviction. We believe the pivotal data will be successful, and we are operating within our existing capital envelope as a signal of management alignment with shareholders through the most consequential six months in this company's history. I want to acknowledge the patients in our pivotal study who trust us with their health and their commitment, the investigators and operators who have executed the trial with skill and rigor, our employees whose focus through a demanding stretch of clinical and operational work has been exceptional, and our shareholders, whose conviction in the science makes everything we are building possible.

Operator, we're ready to take questions.

Thank you. At this time, we'll conduct a question and answer session. As a reminder to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Whitney Ijem of Canaccord Genuity. The line is now open.

Hey, guys. Thanks for taking our question. This is Angela on for Whitney. maybe a question to start on Rejuva. Can you just walk us through how you're thinking about enrollment timelines, the target product profile, what should we expect to see from the preliminary data set in the second half of the year?

Sure. Subject to site activation, there is a several week run-in period for first patients. Just remember, this is a three-by-three study design, first patients will be treated at an initial dose. We'll evaluate safety, feasibility, and initial PK/PD from those three individuals before we consider escalating to the next dosing regime. What you would expect is that each patient will be treated, and then there will be a short period of time in between each individual patient is dosed within each cohort. What the initial thing that we're obviously looking for, and the clear early signal pertains to the safety and the feasibility of the delivery, and that is an answer that we should be able to see within the first one-two weeks of patients being dosed.

We don't expect to really see preliminary PK and PD signals until roughly eight weeks afterwards when the GLP-1 level expression levels should be reaching their target levels, and then the effect on glucose and insulin-related physiology will be discernible. We'll give you an update after those first patients are enrolled on both initial safety and feasibility, and then you'll get a sense for what we expect to see from an efficacy standpoint.

Great. Thank you.

Thanks.

Thank you. One moment for our next question. Our next question comes from the line of Umer Raffat of Evercore. Your line is now open.

Hi, guys. This is Michael DiFiore in for Umer Raffat. Thanks so much for taking my question, and congrats on all the progress. A few quick ones from me. The first one regarding De Novo submission, Harith. My question is an all-comer pivotal success required for De Novo submission, or could a dose response or subgroup data influence the regulatory package there? Separately, any updates in the German commercial use, any insights gained from that? I know it's kinda been a while since that's been going on. Last question is, Yeah, I'll just leave it there. Thank you.

Sure. The De Novo pathway has a different clinical threshold than a PMA. Though I think we feel like we are highly confident in the pivotal trial success under any metric, I don't think that we have anything to worry about there. De Novo, because it's deemed moderate risk, has, you know, and because the FDA thinks about benefit/risk ratio, the De Novo seeks a reasonable assurance of safety and effectiveness, which is often translated to interpret as the totality of clinical evidence rather than any one single P value. I do think that there is flexibility there. I don't think we're going to need it.

With respect to German commercial use, we are continuing to follow patients, and we have patients who are. As you know, we reported two-year data last year to continuing to follow patients up to five years. We will have an update for you in the coming quarters once a reasonable number of patients have hit three years, which hasn't quite happened yet. That's the next major update to come. We're not giving guidance on exactly when that will be, but you can reasonably expect it to be coming in the coming quarters.

Great. Thank you.

Yeah. We're excited about what that can show about the durability of effect, obviously, and round out the clinical picture of what the real-world use looks like for Revita.

Thank you. One moment for our next question. Our next question comes from the line of Jason Gerberry of Bank of America Securities. Your line is now open.

Hey, guys. This is Chi Fong for Jason. Thanks for taking our question. Maybe just piggyback on the De Novo marketing application submission. Would you expect to file to include the one-year REVEAL-1 cohort data and the one-year REMAIN-1 midpoint cohort data in the submission package? To what extent those one-year data, while not in the pivotal cohort, to what extent those one-year data can support the totality of the data in terms of the De Novo marketing application? Thanks so much.

We'll be submitting all of the data to the FDA, and totality of data means totality of data. We've been working on Revita and establishing the science now for the better part of a decade. We have hundreds of patients that we've treated across a range of different clinical venues, clinical trial sites, and patient populations. We do intend to file on the REVEAL-1 data and the REMAIN-1 midpoint cohort data in order to contribute to the totality of that evidence. I believe that the FDA, based on prior experience with De Novo, will consider the totality of available evidence when making their marketing authorization decision in the De Novo pathway. I think that that provides us all of the reassurance and confidence that we are well on our way. The pivotal trial is built to succeed.

We have favorable feedback from the FDA. I think all signs are pointing green for us.

Okay. Great. Thanks.

Thanks.

Thank you. One moment for our next question. Our next question comes from the line of Mike Ulz of Morgan Stanley. Your line is now open.

Good afternoon. Thanks for taking the question. Maybe just to follow up on the RJVA-001 study that you're getting underway here. Can you just comment on the first dose cohort? Should we think about that as an active dose, or is the way to think about it is maybe you started with a lower dose to check the box on safety before you start increasing the dose. Thanks.

Yeah. Mandatory requirement here is that the first dose should be an active dose, and patients should be able to benefit from it. That's absolutely our intent with the first dose. This is a first time of performing this route of administration for this disease. We are obviously going to want to ensure that we are cautious in our approach in putting patient safety first. We are optimistic in being able to see active signals once enough time has transpired after the administration.

Great. Thank you.

Thank you.

Thank you. One moment for our next question. Our next question comes from line of Jeffrey Cohen of Ladenburg Thalmann & Co. Your line is now open.

Hi, Harith and Lara. Thanks for taking our questions. Firstly, could you talk about DDW a little bit and your advisory board and maybe give us a sense of some of the questions, curiosities, pushback, feedback, et cetera, that you received from physicians and clinicians?

I love DDW. It's a great meeting for us. The physicians who attend are leaders in GI endoscopy. Many of them are building practices around metabolic and bariatric endoscopy and are leaders in the society as well as in clinical practice around the country. We have been sharing our REMAIN pivotal midpoint cohort data, our REVEAL open label data. We've been walking through our pivotal study and our commercialization plans and have gotten incredibly positive feedback from folks all over the United States, from L.A. to New Hampshire, from Seattle, Washington, to Miami, Florida.

One benefit we have is that the clinical infrastructure that we built to run our pivotal studies, the physician relationships that we've established, the training that we've done, all represent the baseline sort of commercial distribution infrastructure with champions who are familiar with the technology, who have enrolled the patients in the study, who have seen how they have done with their own eyes. Their enthusiasm gives us the fuel and fire to continue to proceed in a way that is as optimistic as we are.

Super. Thanks for that. Then as a follow-up, could you maybe talk about any net material adds or changes to the IP portfolio the past quarter, including both, potentially Rejuva as well? Thank you.

We continue to strengthen our IP portfolio. We had in Q1, adds to the strength and breadth of our Revita portfolio, and we've been continuing to focus Rejuva on establishing a strong IP landscape around the device, around the procedure, and how the device and procedure and the gene therapy product and how they all work together to ensure what we believe will be a safe and feasible administration of the gene therapy. I don't know if any new patents were issued in the first quarter off the top of my head, but I'm gonna find out, and then I will get you that answer. We do have a very strong and robust portfolio across both Revita and Rejuva. Thank you.

Super. Thanks for taking the questions.

Thank you. One moment for our next question. Our next question comes to line of Joe Pantginis of H.C. Wainwright. Your line is now open.

Hello, everyone. This is Lander on for Joe. Thanks for the updates, and thanks for taking our questions. For Rejuva, when should we expect regulatory feedback from additional European countries for the phase I/II trial? Also, can you provide some color on past, current, or future interactions with the FDA for the progress of Rejuva in the U.S.? Thank you.

We have all of the feedback we need in order to initiate the RJVA-001 study in Europe, and I think that's the most important point. We chose Netherlands because there is an excellent, very highly regarded, internationally recognized GI endoscopist who does clinical research in the area at Amsterdam University Medical Center, where we anticipate our first patients in Europe being treated or being enrolled, has a track record of conducting high-quality gene therapy studies. Our next guidance for you is that we expect feedback from regulatory authorities in Australia in Q3. That's what I would look to next.

With respect to the FDA, While we've had positive repetitive interactions with the regulators in Europe, we have not yet approached the FDA on this topic and don't have a guidance for you yet on when we will. Our plan is to secure early safety feasibility data in this first human study before discussing with the FDA.

Awesome. Very helpful. Thank you so much. Thank you.

Thank you.

Thank you. I'll now turn the call back to Dr. Rajagopalan for closing remarks.

Thank you everyone. We are executing. The science is working. We have three major clinical catalysts from REMAIN-1 program coming in the next six months with pivotal top-line data in early Q4. Thank you for the call.

This concludes today's conference call. Thank you for participating. You may now disconnect.

Good afternoon, and welcome to Fractyl Health Fourth Quarter and Full Year 2025 Financial Results and Business Update Call. [Operator Instructions]. I'll now turn the call over to Brian Luque, Head of Investor Relations and Corporate Development at Fractyle. Brian, you may now begin.

Thank you. This afternoon, we issued a press release that outlines the topics we plan to discuss today. The release is available at www.fractyl.com under the Investors tab. Joining us on the call today are Dr. Hartih Rajagopalan, Chief Executive Officer; and Lara Smith Weber, Chief Financial Officer. During this call, we make forward-looking statements, which involve risks and uncertainties that may cause actual results to differ materially from our forward-looking statements. We provide a comprehensive list of risk factors in our SEC filings, including the annual report on Form 10-K filed today, which I encourage you to review. Any forward-looking statements on the call are subject to substantial risks and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of the statements, even if subsequent events cause the company's views to change. It is now my pleasure to pass the call over to Harith.

Thank you, Brian, and good afternoon, everyone. Millions of Americans are starting GLP-1 therapy. Most of them will stop within a year. Data show that when they stop, the weight comes back, approximately 10% of their body weight within 6 months and approximately 15% within 12 months. Every one of those patients faces a moment with no durable off-ramp, no alternative to either resuming chronic pharmacotherapy or accepting the risk of regain. Revita is being built for that moment. For those of you who are new to the Fractyl story, Revita is our lead asset. It's like LASIK for obesity, an endoscopic procedure designed to durably maintain weight loss after GLP-1 discontinuation. And Rejuva is our smart GLP-1 platform targeting long-term metabolic remission from a single dose. Today, I want to tell you where we stand in the development of Revita for post- GLP-1 weight maintenance, what we have learned since we last spoke to you about the clinical data and share new favorable feedback we have received from the FDA on our filing strategy. I'd like to start by naming something directly. In January, we reported 6-month data from the REMAIN-1 Midpoint cohort. The past several weeks of analysis have given us a level of precision about which patients benefit most from Revita and at what procedural profile that we did not have before. This clarity has strengthened our conviction in Revita and has helped us finalize the pivotal study's key design elements to ensure we are set up for regulatory and commercial success. Today, we will share what we now know and why the picture is both more precise and more compelling than the headline p-value initially suggested. Let me walk you through 4 key pillars that give us conviction in the opportunity in front of us. Number one, the clinical signal is real. Number two, the pivotal is built to succeed. Number three, the path from data to commercial value is clearer than ever. And four, we have the runway to get to the definitive pivotal data without any planned incremental capital raise. Now let's start by discussing the clinical signal. You will recall that the Midpoint Cohort was a pilot randomized, double-blind, sham-controlled study that enrolled 45 patients with obesity who were GLP-1 naive. They were started on tirzepatide to achieve at least 15% total body weight loss and then randomized 2:1 to Revita versus sham. This 45-patient study was designed as an interim read to validate the design and the powering assumptions for the REMAIN-1 pivotal study, not as a powered stand-alone efficacy study. Nonetheless, the 6-month Midpoint Cohort data did not look as strong as the 3-month data. Early analysis that we shared at the time of data release was that site level heterogeneity appeared to account for the attenuation of the clinical signal in some patients. Further investigation has revealed that the site level heterogeneity is, in fact, differences in ablation length or treatment dose at early clinical sites and that these differences in ablation length are a key driver of efficacy differences between patients. Critically, we have not identified site level operational issues. What we did find was even better, a strong dose response relationship between ablation length and weight maintenance after GLP-1 discontinuation. This is a strong positive signal for the Revita mechanism of action and for the potential success of the pivotal study. We have long understood from our work in type 2 diabetes that Revita's treatment effect is proportional to the extent of duodenal resurfacing. Our first-in-human feasibility and dose escalation pilot study in type 2 diabetes was published in Diabetes Care in 2016 and prospectively demonstrated a clear relationship between ablation length and glucose lowering. Since that time, we have been systematically optimizing the procedure profile across successive clinical studies to deliver longer ablation length from 9 centimeters in the first in human to over 16 centimeters on average in REMAIN, and have seen greater potency in our studies without compromising patient safety. And because of this experience, our pivotal study already prespecified an ablation length dose response secondary endpoint. When we applied this dose response analysis to the Midpoint Cohort 45 patients, we observed a statistically significant p less than 0.05 monotonic and clear relationship between ablation length and weight maintenance treatment effect at 6 months. Participants who received more than 14 centimeters of ablation regained approximately half the weight of sham, whereas those individuals with subthreshold ablations accounted for the apparent narrowing of treatment effect between month 3 and month 6 that we saw in our January data release. This finding is consistent with our prior evaluation of ablation length on patients with type 2 diabetes, and it makes sense biologically. The duodenum is lined with enteroendocrine cells that drive key metabolic signaling pathways. The density of that cell population is distributed along the length of the duodenal mucosa and duodenal dysfunction from high fat high sugar diet extends along the length of the entire duodenum in animal models. A longer ablation resurfaces a greater proportion of that signaling surface, producing a more complete metabolic effect, which is exactly what our dose response data confirmed. In the REMAIN-1 pivotal study, we trained physicians to ablate from the ampulla of Vater to the ligament of Treitz, which are anatomical landmarks toward the beginning and the end of the duodenum, respectively. Based on our work in type 2 diabetes, we aim for an ablation of at least 10 centimeters, but encourage physicians to ablate more if they deemed it appropriate. In the pivotal study, the mean and median ablation length are more than 16 centimeters, providing ample opportunity to demonstrate an enhanced clinical signal reflecting more complete duodenal ablation. Notably, all pivotal investigators were successfully trained to achieve more than 14 centimeters of ablation, confirming procedural scalability and feasibility across diverse operators and patient anatomies. So taking a step back, what we have is a clear monotonic dose response, which is exactly what you would expect to see from a true biological intervention. All drugs and all procedural therapies that work like drugs should show a dose response relationship. That's what biological activity looks like. And ablation dose is a specific, measurable, controllable and standardizable metric for repeatable outcomes in a broad population. So having established ablation length as a key procedural driver of Revita's potency, let's turn to patient selection. The scientific community has long understood that the magnitude of initial weight loss on GLP-1s is proportional to the magnitude and speed of weight regain upon discontinuation. So we designed REMAIN-1 with a greater than 15% total body weight loss threshold at run-in, specifically because we expect the treatment effect to scale with the degree of pre-randomization weight loss. Midpoint Cohort results at 6 months confirm this relationship. Participants with greater than 17.5% weight loss showed an early, sustained and compounding separation from sham through 6 months. The pivotal has enrolled a population that is built to capture a large effect size that scales to the magnitude of initial weight loss as well with a mean run-in weight loss of 18.3% in the Pivotal Cohort. So when we now consider the right dose in the right patient, we observed the signal to be strongest among participants with higher weight loss who received longer length of duodenal ablation. And in these individuals, Revita-treated patients experienced only 2.9% weight regain at 6 months compared to 9.9% in the sham arm, approximately a 70% reduction in post GLP-1 weight regain. Like ablation length, the treatment effect scale monotonically with the magnitude of weight loss as well. Another way to think about it is that in this optimized patient cohort in the midpoint study, patients retained about 88% of their body weight loss on tirzepatide compared to only about 60% in the sham arm at 6 months. We believe this degree of weight loss maintenance will be highly compelling to key commercial stakeholders. It is a prospectively definable, commercially significant population. It is the exact population that the pivotal study has enrolled and will enable efficacy endpoints in our pivotal study later this year. This is also classic translational pharmacology applied to a procedural therapy, identification of the right patients and the right dose to optimize the clinical profile and achieve a large treatment effect. Turning now to the pivotal study statistical analysis plan and operational progress. Our plan was always to analyze the 6-month Midpoint Cohort to inform our understanding of the key drivers of effect size and then to use this information to prespecify the Pivotal Cohort statistical plan. The pivotal SAP, which we will file with FDA shortly, incorporates these parameters as prespecified analyses, and this will enable clarity on effect size and durability as a function of treatment dose and patient selection in the pivotal study. I also want to provide clarity about our endpoint structure. REMAIN-1 has 2 co-primary endpoints. The first is percent body weight regain in the Revita arm versus sham at 6 months. This is the data we expect in early Q4. The second co-primary is the proportion of Revita-treated patients who maintain at least 5% total body weight loss at 1 year after GLP-1 discontinuation. Both co-primaries are required to be met at p less than 0.05 for overall study success and we believe the pivotal is well powered at over 90% to achieve that result even under conservative assumptions. In addition to these co-primaries, we will present a comprehensive set of secondary endpoints, including a dose response analysis, a high responder population analysis, cardiometabolic markers and patient-reported outcomes, including reduction in cravings for sugary foods. In February, we completed randomization in the full study of the Pivotal Cohort with over 300 participants across more than 30 sites and over 20 operators across the United States, making this the largest sham-controlled GI endoscopy pivotal trial ever conducted. Every operational metric that predicts pivotal success is tracking favorably. Retention exceeds 95%. Medication resumption rates are below our model assumptions. The blinded adverse event profile remains encouragingly consistent with what we have seen in prior studies. And we remain on track to deliver top line 6-month primary endpoint data in early Q4 2026. Turning now to regulatory progress. Earlier this month, we received favorable FDA feedback on our De Novo classification request. You may remember that we aim to get that feedback in Q2, but our most recent discussion with FDA revealed that they have reviewed safety data to date, and they acknowledge that Revita's safety profile is consistent with a Class II device classification or a moderate-risk De Novo device. With this positive feedback now in hand, ahead of schedule, we are on track for De Novo submission in late Q4 2026 with 6-month pivotal data in hand. There are several advantages to the De Novo pathway compared to the PMA pathway. It is a more capital efficient, faster and strategically superior path. So now let's turn to the commercial opportunity because the landscape is evolving in ways that reinforce the urgency of what we are building and the path from clinical data to commercial value is becoming clearer and nearer than ever. With an anticipated filing via the De Novo pathway at the end of this year, we're also preparing ourselves for our potential commercial launch. There is a large and growing population on GLP-1 drugs with estimates projecting over 30 million users in the next several years. We estimate that as newer agents become more effective, more than 50% of patients are expected to lose more than 17.5% of their total body weight on GLP-1s and more than half of these are likely to discontinue. As a result, the post-GLP-1 unmet need is intensifying rather than abating. A large study published in BMJ Medicine last week following over 330,000 patients showed that GLP-1 cardiovascular benefits erode rapidly after discontinuation with the authors coining the term metabolic whiplash. Resuming treatment did not fully restore lost benefits, underscoring the need for durable maintenance solutions. Meanwhile, the payer landscape is shifting. CMS has expanded Medicare coverage of GLP-1s, driving a massive increase in the addressable patient population, but also intensifying the economic pressure on payers who are now grappling with the long-term cost of chronic therapy. This creates an unprecedented window for Revita, the first FDA breakthrough device designed for post-GLP-1 weight maintenance as a potentially durable, cost-effective solution that gives people an off-ramp from chronic pharmacotherapy while preserving the metabolic benefits they work so hard to achieve. On reimbursement, we now have a clear and validated pathway. We plan to file a Category III CPT code application this summer with a code expected to be effective in the summer of 2027. The payment economics work for hospitals from nearly day 1. Transitional pass-through payment by a CMS provides a separate incremental mechanism to cover the cost of the Revita disposable device on top of the facility rate, ensuring that hospitals can maintain a positive contribution margin while offering the procedure to patients. Revita is the only potential procedural therapy in development for post-GLP-1 weight maintenance, and we believe the commercial infrastructure will be ready to move quickly upon clearance. Briefly, let's turn to Rejuva, our smart GLP-1 platform targeting long-term metabolic remission from a single dose. We submitted clinical trial applications for RJVA-001 in type 2 diabetes to regulators in the EU and Australia, and we anticipate regulatory feedback in Q2 2026, expect reporting first-in-human dosing and preliminary data in the second half of this year. The Rejuva program is advancing within a disciplined spending framework that does not compete with Revita for capital, and we will share more on the platform at an upcoming Investor Day. Let me frame the anticipated catalyst-rich path ahead before I hand it to Lara. In Q2, we will see 1-year REVEAL-1 open-label data and receive CTA regulatory feedback on RJVA-001. In Q3, we will see 1-year REMAIN-1 Midpoint Cohort randomized data, and we expect to be able to demonstrate continued compounding treatment effect and durability at that time in a randomized data set. In early Q4, we will anticipate seeing top line 6-month randomized data from the REMAIN-1 pivotal study. This is the single most important catalyst in our company's history. And in late Q4 this year, potential De Novo marketing application submission for Revita in post-GLP-1 weight maintenance. In the second half of this year, we will also see human dosing of RJVA-001, subject to CTA authorization and preliminary safety and PK data. Each of these milestones move us closer to delivering the first potential procedural therapy for maintenance and weight loss after GLP-1 discontinuation, and it is a catalyst-rich year ahead. Lara?

Thank you, Harith. Research and development expenses were $16.5 million for the quarter ended December 31, 2025, compared to $20.3 million for the same period in 2024. The decrease was primarily due to our strategic reprioritization in Q1 2025, resulting in lower personnel-related costs and reduced costs associated with the pausing of the REVITALIZE-1 study, partially offset by continued investment in REMAIN-1 and Rejuva. SG&A expenses were $6.8 million for Q4 2025 compared to $4.9 million for the same period in 2024. The increase was primarily due to underwriters commissions associated with our August 2025 financing. We reported a net loss of $43.7 million for Q4 2025 compared to $25 million in Q4 2024. However, the $20.2 million of the increase was a noncash accounting change in the fair value of our warrant liabilities, which does not reflect a change in our underlying operating performance. Stripping that out, our operating expenses for the quarter were $1.9 million lower than the same period in 2024. Adjusted EBITDA was negative $21.2 million for Q4 '25 compared to negative $22.1 million for Q4 2024, reflecting the decrease in operating expenses. As of December 31, 2025, we had approximately $81.5 million cash and cash equivalents. Based on our current business plan, we believe this cash position, combined with the $4.1 million subsequent proceeds from warrant exercises received in January 2026 will fund operations into early 2027. Importantly, this funds the company beyond the anticipated REMAIN-1 pivotal data readout in early Q4 2026 and through a potential De Novo submission in late Q4 2026. With that, I'll turn it back to Harith for one specific item on capital strategy and a few closing remarks before we open for Q&A.

Thank you, Lara. Before we open Q&A, I want to address capital strategy directly and remove any ambiguity. We have closed our ATM facility, and we do not have plans to raise capital before we have pivotal data in hand. Our runway extends into early 2027. This is a deliberate commitment grounded in conviction. We expect the pivotal data will be positive, and we will operate with discipline within our existing capital envelope as a signal of management's alignment with shareholders through a key moment. A few final comments. First, we believe the clinical signal is real with a strong dose response and a clear GLP-1 responder target population. Second, the pivotal is built to win with strong powering on the full cohort and enrichment in an optimized cohort of patients with high running weight loss and longer ablation lengths. Third, we see a clear path to commercial value with favorable De Novo feedback and a large, defined and growing market opportunity. And lastly, we are funded to the key pivotal value inflection point without planned incremental capital raise between now and then. We have the science, the runway and the team to prove it. We look forward to sharing more data this summer and into the fall. I want to express my deep gratitude to our employees whose dedication and focus through a challenging year has been nothing short of extraordinary, to the physicians and investigators who believe in the science and bring it to patients with skill and care to the patients who trust us with their health and their hope and to you, our shareholders, whose conviction fuels everything we do. Operator, we are ready to take questions.

[Operator Instructions]. And our first question comes from the line of Whitney Ijem of Canaccord Genuity.

This is Angela on for Whitney. Can you guys just remind us how the ablation length is determined again, is that it's after the patient is already like during the procedure, right? And so yes, I guess like how is that length determined? And then it sounds like 16 centimeters is the cutoff now like going forward, is that the target minimum ablation length?

Yes. Great question, Angela. Happy to clarify this point because it's important to how we think about standardizing this procedure as we go forward and how we are going to analyze the pivotal data as well. When we looked at the type 2 diabetes patient population, we saw a dose response where ablation was defined as the length of the total amount of duodenum that was ablated. When we did our first-in-human study, we saw that about 10 centimeters of ablation had more glucose lowering efficacy than 3 centimeters. We are seeing the same thing now in obesity, but at higher lengths of ablation. Our ablation balloon is 2 centimeters long. In the procedure, we count the number of ablations that are performed longitudinally along the length of the duodenum, and that allows us to calculate the ablation length. What is clear is that the ablation length for weight effects is greater than or equal to 16 centimeters. That will be our operating standard going forward and will be built into the key secondary endpoints in our pivotal study. And in those patients, we see a clinically meaningful and compounding treatment effect in the Midpoint Cohort. We believe this to be the reason for heterogeneity that we saw back in January, and we're very gratified to have the data to be able to give us clarity on the precision of what is needed in order to deliver benefit to patients.

Great. Maybe just a quick follow-up. I guess, does this impact how doctors are going to be trained in the future in terms of length of ablation? And was it -- were they conducting less ablation because they were less comfortable with it? Or if you could just provide more color around that?

Well, in the pivotal study, we advise patients -- doctors to ablate at least 10 centimeters and from the anatomical landmark at the beginning of the duodenum towards the end of the duodenum. But it was less to the physician's discretion how much ablations to perform. In that study, everyone was trained to be able to successfully perform greater than 14 centimeters of ablation across the board. And so we believe that we can easily train physicians to do that consistently now that we have the data to support that length being the efficacious dose.

Our next question comes from the line of Michael DiFiore of Evercore ISI.

One on the De Novo pathway. It seems that you're increasingly more confident that the FDA could accept your De Novo submission based on early feedback. And I guess my question is, to what extent does efficacy play in the final determination here? Or is it all about safety? And then I have a follow-up.

Well, I think the De Novo pathway determination versus, say, a PMA determination is principally a safety consideration because what the FDA is thinking about is whether this is a moderate risk device in De Novo versus a high-risk device in a PMA. And then the efficacy threshold for PMA and De Novo are also nuanced -- have nuanced differences. The efficacy threshold for PMA is valid scientific evidence, whereas the efficacy threshold for a De Novo is reasonable assurance of safety and effectiveness.

I see. That's helpful. And then just back on the ablation length. I think I and a lot of other folks were under the impression that this was already standardized. But now you made it clear that in the pivotal studies, physicians were instructed to ablate at least 10 centimeters. And I guess my question is in the real world, based on the average patient, is 16 centimeters readily achievable? Or is the average patient's anatomy more conducive to less centimeter ablations?

In the Pivotal Cohort, mean and median ablation length was greater than 16 centimeters and is readily achievable by all of the investigators that we've trained, and we believe that will be translatable to the broader population.

Our next question comes from the line of Jason Gerberry of Bank of America Securities.

This is Chi on for Jason. Maybe a follow-up on the ablation length. Can you provide more color on the post-hoc analysis for the midpoint data set? More specifically, can you remind us the ablation length and GLP-1 induced weight loss from the Midpoint Cohort and how that compares to the metrics you provided for the Pivotal Cohort? And secondarily, how much variability in the ablation length you saw in the Midpoint Cohort compared to the Pivotal Cohort? And I guess, ultimately, how does this post-hoc analysis impact your confidence for the pivotal readout later this year?

Well, this is a post-hoc analysis in the Midpoint Cohort. It was already a prespecified analysis in the pivotal study and is consistent with prespecified studies we've conducted on dose in type 2 diabetes in the past. In the Midpoint Cohort -- sorry, in the Pivotal Cohort, mean and median ablation length are greater than 16 centimeters and the average ablation length is longer than it was in the Midpoint Cohort. And we feel confident that we can train physicians to perform longer ablations in the pivotal. All of this translates to a high degree of conviction in the pivotal study. Number one, we are very well powered at well over 90% for the full cohort, and we have key secondary endpoints that we have prespecified that will interrogate patients who receive more than 16 centimeters of ablation and in patients who receive -- who have more running weight loss on the GLP-1. And we are confident that each of those independently and collectively will drive larger and compounding treatment effects in the pivotal study and will provide clarity on how Revita can be used in which patient and at what dose in order to achieve a clinically meaningful signal that can translate to commercial utilization.

Got it. So the ablation length for the Pivotal Cohort is what you have observed is longer than the ablation length in the Midpoint Cohort?

That's right.

Okay. And given you have already fully randomized the Pivotal Cohort, basically, is it fair to assume that all the ablation had already occurred and you're talking about ablation length you have observed for all the procedures that conducted?

Yes, that's locked. And I think we're saying that we're more than 1 month out from the last randomization now. And the safety signal in our blinded analysis continues to be very encouraging. And so we feel quite confident that the efficacy is the question in the pivotal study and the data that we're sharing with you today meaningfully increase the probability of success on the efficacy angle as well.

Our next question comes from line of Mike Ulz of Morgan Stanley.

And maybe just another one related to ablation. Just curious how long it takes to sort of train these physicians to be able to do the procedure to ensure adequate ablation. Is that something that's fairly quick? Or how much experience does it take to kind of make sure that they're hitting that mark?

This training that we've built is -- works very well. It takes less than 3 to 4 cases to train a physician to perform ablations. The shorter length of ablations that we sometimes see in the Midpoint Cohort and the Pivotal Cohort are often reflective of the first couple of cases that the physician is performing and yet very soon, they get very comfortable with it and then are consistently delivering longer ablations. The huge advantage of a prospectively defined dose response in the pivotal is that it allows us to standardize the treatment -- the training regime and the treatment recommendation in commercial use. And I think that's going to help standardize real-world outcomes.

Our next question comes from the line of Jeffrey Cohen of Ladenburg Thalmann & Company.

Sorry to be redundant. So on the -- in Q3, when we see the 1-year remain Midpoint Cohort, will we see further analysis by length as far as the data that you're reading out?

Yes.

Got it. And then could you talk a little bit about the energy delivery and the temperatures involved? Has anything changed as far as the delivery from the generator between the Midpoint Cohort and the Pivotal?

No, nothing has changed. And I think one point that you should take confidence in is that even though we went from a small number of sites in the midpoint to a much larger number of sites and operators and patients, the treatment that we've been able to train physicians to perform has been remarkably consistent and standardized over the course of time. The only difference that we are sharing with you now is that we can give specific guidance on what length of duodenum to aim for in obesity. And that is very useful information. We're glad to have it.

That's helpful. And then can you talk about the CPT code. So as I understand it, if you file during the midpoint somewhere in 2027 that, that could or would take effect January 1, '28. Are you also suggesting that it's possible that you'll have a T code that would take effect sometime in 2027?

We're anticipating filing for the Category III CPT code in June of this year. It's reviewed in September and should go into effect in the summer of '27, July 1. And we are also intending to file for a transitional pass-through payment through CMS immediately upon FDA authorization, and that's a quarterly review cycle. So that can go into effect very quickly upon launch. That's why we said that there was essentially no daylight between potential clearance authorization in the United States and reimbursement authorization for hospitals to begin to use it.

OOkay. And I'm assuming you'll also take on payer discussion late this year, commencing late this year as far as payer discussion?

That's right. And when you think about it, we will have a fully formed clinical profile by early Q4. 12-month randomized data from REMAIN-1, 12-month open-label data from REVEAL-1, 6-month randomized data from the full Pivotal Cohort of 300 patients. That's a fully derisked clinical package that we could then use to inform our payer discussions and drive towards our regulatory submission calendar.

Our next question comes from the line of Joe Pantginis of H.C. Wainwright.

So my first question is shorter, but maybe a more complex answer. So first, with the De Novo filing positive feedback, how would we view the totality of regulatory submissions over the next -- over the next year or so with regard to is it a multistep process? Or is it similar to a rolling BLA? Or how should we view it?

There are 3 main packages to the regulatory submission. There is a design history file, which is the device design. There's a manufacturing file, which reflects how we manufacture our systems. and then there will be clinical data. We will have a full package of 6-month data by the end of this year. There's -- we will also be ready to submit 12-month data in the first quarter of 2027, should that be necessary.

That's great. And then if I heard you correctly, correct me if I'm wrong, it sounded like you're going to be filing the SAP relatively soon. So with regard to the ablation length that we've been discussing today, and it's very intriguing data, by the way, how would you look at -- and you mentioned it's a prespecified population. How would that factor into the statistical analysis plan and also the role of the secondary endpoints that you mentioned and the hierarchy of them?

Great question. Obviously, details on the hierarchy are going to be pending our conversation with the FDA, and we'll share that with you when we have it. I would make 2 points right now. Number one, the sweet spot of the enrollment and randomization of the pivotal study are exactly the patients in whom Revita appears to be working best. The mean ablation length was more than 16 centimeters, which is where Revita's efficacy is very clear based on the midpoint cohort. And the mean run-in weight loss was over 18% total body weight, which is where Revita's efficacy is also very clear. So the right down the middle of the fairway of our pivotal enrollment is exactly the sweet spot of where we are seeing efficacy. And so we're confident in that. And we have designed key secondary endpoints in order to be able to demonstrate that very clearly.

Thank you. I'll now like to turn the call back to Dr. Rajagopalan for closing remarks.

Well, thank you, everyone. The science is working. The pivotal is on track and we look forward to delivering the definitive data this fall. Thank you all very much.

This concludes today's conference call. Thank you for participating. You may now disconnect.