Fractyl Health, Inc. Common Stock

Thank you. This morning, 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. Presenting today will be Dr.

Harith Rajagopalan, Co-Founder and Chief Executive Officer of Fractyl Health. Before we begin, I'd like to remind you that 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 quarterly report on Form 10-Q filed on August 12, 2025, 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 call -- to pass the call over to Harith.

Thank you, Brian. Good morning, everyone, and thank you for joining us this morning.

Today is a milestone moment for Fractyl and for the field of obesity. For the first time ever, we are presenting the first prospective randomized double-blind controlled data from the REMAIN-1 midpoint cohort, in which we showed that Revita prevented weight regain 3 months after GLP-1 discontinuation.

The data we're presenting today represent the beginning of a new potential therapeutic category in obesity post GLP-1 weight maintenance, a field that we believe Fractyl is uniquely positioned to lead. And today's results are the start of a period of momentum and acceleration with 4 weight maintenance data readouts in the next year, culminating in top line pivotal data and potential PMA filing in the second half of 2026.

Today, we've also announced that we expect to have cash to fund operations into early 2027 through these key milestones. We believe this is a moment where Fractyl could step into the forefront of what comes next after GLP-1s, persistent weight loss maintenance.

When we founded Fractyl, we started with a bold hypothesis that duodenal dysfunction is a root cause in obesity and that mucosal ablation can lead to a safe, scalable and durable effect. Decades of diet-induced injury caused duodenal dysfunction, disrupt gut brain signaling, fuel insulin resistance and to drive weight gain in millions of people.

By resurfacing and regenerating the duodenal lining, we believe we can restore normal signaling, reset hunger control and create a durable metabolic reset. In prior clinical studies, Revita has been shown to lead to sustained improvements in weight and hemoglobin A1C that lasted for up to 2 years of durable metabolic benefit, and Revita has a large safety database showing excellent tolerability with side effects that have generally been mild, infrequent and transient.

Revita's effects in these clinical studies also occurred rapidly within 1 to 3 months and were sustained for up to 2 years. The question now is whether Revita can prevent weight regain after the discontinuation of GLP-1 drugs because this has become the single most important need in obesity today.

Even though they are effective, most patients stop GLP-1 drugs within a year and weight and metabolic rebound occur rapidly upon discontinuation. The first symptoms are profound hunger and food noise, often occurring within weeks of treatment discontinuation.

Patients stopping GLP-1s represent the hardest-to-treat patient population within obesity. And for this reason, Revita was granted breakthrough device designation for post GLP-1 weight maintenance from the FDA and why this is a hard-to-treat population is a compelling first population for Revita's first clinical demonstration in obesity.

Our REMAIN-1 program is modeled off Eli Lily's SURMOUNT-4 study, in which patients who were given tirzepatide for 36 weeks quickly regained almost all of the weight they had lost after stopping therapy. Let's start with the key takeaways from our data today.

The REMAIN-1 midpoint cohort randomized 45 subjects to Revita versus sham after stopping GLP-1, and the results are a resounding success, supporting the potential safety, efficacy and strategic positioning of Revita in a post-GLP-1 weight maintenance category. First, there was clear and unmistakable evidence of Revita's activity already at 3 months.

Revita patients actually lost 2.5% more body weight even after stopping tirzepatide, while sham patients regained 10% of their weight. That is a meaningful and clinically significant 12.5% treatment difference with strong statistical significance and a p-value of 0.014.

Second, just as important, Revita has continued to show an excellent safety and tolerability profile through 3 months, no device-related serious adverse events have been reported, and side effects, again, were infrequent, transient and mild. Third, the midpoint cohort was deliberately designed to replicate the pivotal cohort with the same protocol, patient population, inclusion and exclusion criteria, clinical trial sites and treating physicians, with the goal of ensuring the greatest possible similarity to our ongoing pivotal cohort.

Today's data also represent important evidence that if Revita can succeed in this hard-to-treat population, we believe it also opens the door for Revita as a potential backbone therapy across a spectrum of obesity and metabolic disease. Our development path has been disciplined and staged with multiple clinical cohorts studied in weight maintenance concurrently.

REVEAL-1 is an open-label cohort designed to evaluate Revita's potential benefit in the real world with patients who need to or want to stop GLP-1s. The REMAIN-1 midpoint cohort is a pilot, randomized, sham-controlled proof-of-concept study in post-GLP-1 weight maintenance, and the pivotal cohort is a single registrational study required for approval in the U.S., with randomization expected to be complete in early 2026 and top line data and potential PMA filing expected in the second half of '26.

As a reminder, in June, we presented open-label data from the REVEAL-1 open-label cohort, suggesting that Revita can potentially prevent weight regain after stopping GLP-1s. REVEAL-1 showed at the time that 12 of 13 patients maintained weight loss at 3 months after stopping tirzepatide, with 6 of 13 actually losing further weight.

This is far better than the expected 5% to 6% weight regain that would have been predicted at that time point. These were intriguing data, but they were 13 subjects and they were only open label.

For this reason, we enrolled the midpoint cohort, a randomized sham-controlled study, which enrolled 45 adults with obesity without type 2 diabetes, GLP-1 naive, started on tirzepatide and titrated to achieve greater than 15% weight loss. Once they hit 15% weight loss, tirzepatide was stopped and patients were then randomized 2:1 Revita versus sham.

In the midpoint cohort of the 45 patients who were randomized, 29 were in the Revita arm versus 16 in sham, with 100% retention through 3 months across multiple clinical trial sites. Procedures were executed consistently and with high quality, showing the feasibility and scalability of this technique.

All 45 randomized subjects are included in the safety and efficacy analysis today. Screening demographics show that our patients mirror the real-world GLP-1 population with an average BMI of 37, 100 kilograms prior to starting a GLP-1, 80% of the population were female, many had pre-diabetes.

These are the patients doctors see every day, meaning that the REMAIN-1 study is broadly relevant to the obesity crisis as it exists today in the United States. After tirzepatide, both arms lost 18% of their body weight over a period of 4 to 6 months.

They lost 40 pounds in that period of time before the tirzepatide was taken away. This study was designed to create some of the world's hungriest humans.

The physiologic drive to regain weight after stopping tirzepatide is enormous, and this was the toughest possible test of Revita's potential to maintain weight loss, a rigorous stress test, if you will, for Revita in weight maintenance. And that's why the results we're about to show you are so striking.

At 3 months post discontinuation, Revita patients lost an additional 2 kilograms of body weight on top of the 18 kilograms of body weight that they lost during the tirzepatide run-in period. Sham patients on the other hand, regained 8 of the 18 kilograms that they had lost.

That is a 10-kilogram treatment difference with strong statistical significance of p equals 0.014. The sham curve looks like one would expect, an immediate steady weight regain.

But the Revita curve is different. Patients not only maintain their weight loss, but they actually lost more weight even after stopping tezeptide.

Here are the same data in terms of percent total body weight and confidence intervals, unmistakable evidence that Revita prevented weight regain with clinically and statistically significant results with an end of only 45 randomized patients. This is the first randomized blinded study, suggesting that weight maintenance can be possible without chronic drug therapy.

This is a game changer because it challenges the core assumption that obesity care must orbit around lifelong medical therapy. It shows that a metabolic reset may in fact be possible.

Now as compelling as a demonstration of Revita activity is, the tolerability profile and safety data are equally compelling. Here's what we saw, no device-related serious adverse events, just 4 mild, self-limited, procedure-related adverse events often seen with endoscopy.

These excellent tolerability data are consistent with Revita's prior clinical study experience and are a huge asset when compared to GLP-1 drugs themselves in the management of the disease. That's it.

We believe the data suggests that Revita could offer a potential off-ramp that can be safe, tolerable, scalable and importantly, consistent with the type of procedures that endoscopists deliver for their patients every day. That's why safety here is more important than a data point.

It's a key market enabler. The midpoint cohort is designed to mirror the design and execution of the ongoing pivotal study, same inclusion and exclusion criteria, same sites, same physicians and same endpoints.

In the pivotal cohort, we will measure the percent of patients -- percentage of total body weight regained at 6 months and the responder rate in the Revita arm at 12 months. This pivotal study is fully enrolled, and we are randomizing ahead of our previously reported schedule.

We anticipate completing randomizations in early 2026, whereas we had previously guided to H1 2026, with top line pivotal data and potential PMA filing expected in the second half of '26. This is a disciplined path to potential commercialization.

The midpoint cohort has already strengthened confidence in Revita's potential to safely and effectively maintain weight loss, and the pivotal cohort is the next logical step and it is running ahead of schedule. At 3 months, we have already seen clear statistically significant evidence of Revita's effect, with a 12.5% treatment difference compared to sham.

In our prior clinical work, early weight maintenance signals at 1 to 3 months were highly durable at longer time points. Meanwhile, the sham arm would be predicted to continue to gain weight based on the results from tirzepatide withdrawal from Lilly's SURMOUNT-4 study.

And because the midpoint cohort was deliberately designed to mirror our pivotal cohort, again, same protocol, same site, same treating physicians; these results today provide strong read-through to what we may expect to see at the pivotal's 6-month primary endpoint. Taken together, the midpoint cohort gives us confidence in the pivotal study design and reinforce Revita's potential to be the first therapy for post GLP-1 weight maintenance.

Enrollment in our pivotal study was incredibly fast and finished 3 months ahead of our most optimistic scenarios. At some centers, demand outstripped capacity, and it became obvious to us there is clearly extraordinary demand for a product that has the potential to be an off-ramp from GLP-1s.

For investors, we believe this should be seen as an early proxy for potential commercial adoption if we successfully develop and obtain approval. And for physicians, it validates that this procedure can fit into existing clinical practice.

It underscores the incredible unmet need that we are targeting. Patients are not just willing, they are eager to find a durable alternative that will help them maintain their body weight loss after stopping medicines.

Now let's take a step back and talk about the potential commercial implications of what you have just seen. If approved, we believe Revita could be commercially attractive because it can fit seamlessly into existing endoscopy practice.

GI suites already have the infrastructure, and endoscopists already perform similar procedures at scale. On the payer side, the story is just as compelling.

Health plans are grappling with the sustainability of lifelong GLP-1 spending. Revita has the potential to offer something that they are actively seeking, a durable solution for long-term weight maintenance.

Early payer feedback has been encouraging, and we believe our pivotal data will be an inflection point for reimbursement and coverage. From a go-to-market perspective, if approved, we are planning to deploy a proven sales model.

A sales force would place Revita into hospitals and endoscopy centers. And it is worth noting that there are 800,000 patients with obesity who are on a GLP-1, who will get an endoscopy this year already for other reasons.

Endoscopy suites are already calling patients and telling them to stop their GLP-1 prior to these endoscopies. And most of these patients do not want to be on a GLP-1 drug for the rest of their lives.

We believe many of them would choose Revita, and this is a readily accessible patient population who are already in the clinics of our treating physicians. To summarize, the midpoint cohort achieved its goal at 3 months, one, clear evidence of activity in maintaining weight after stopping GLP-1 in the hardest-to-treat obesity population with highest unmet need; two, a clean safety profile and tolerability thus far; three, strengthened confidence in the potential for success in the pivotal cohort.

Looking ahead, we look forward to 4 major weight maintenance readouts in the next 4 quarters. The randomized midpoint cohort will have 6-month data readout in Q1 2026, the pivotal cohort is randomizing ahead of schedule.

We expect to have top line data and potential PMA filing in H2 2026. And it's worth asking, what does this mean for where Revita can go from here?

The clinical data are highly compelling and the potential commercial value proposition to stakeholders is clear. We believe that Revita has a potential to have a place, not just for maintenance, but also for induction, not just for GLP-1, but also alongside GLP-1 as a potentially true new backbone therapy in the management of obesity.

This is a rare opportunity to develop and establish such a backbone therapy. We are not competing in the GLP-1 race, we are aiming to build what comes next.

With Revita, Fractyl is positioned to lead the new era of obesity and metabolic disease care. And with that, I would like to thank the people who make this work possible.

To our employees, thank you for your relentless drive and belief in our mission. To the physicians and investigators advancing our clinical programs with care and commitment, we are so proud to partner with you.

And to the patients participating in our trials, thank you for your courage and your trust. To our investors, thank you for your continued support and conviction.

Operator, we are now ready to take your questions.

This is Rohit on for Mike. Congratulations on the great data.

So just in terms of the patients that you saw lose weight, can you just talk about what percentage of the 29 patients lost weight? And was there anything unique about these patients?

Rohit, as you know, when we saw the open-label data, you -- there was a significant plurality of the patients who lost weight and most of the patients maintained body weight. We're seeing a similar profile in the Revita patients -- in the Revita arm in the study as well.

Got it. Okay.

And then just a second question, just any read-throughs to the 6-month data? What did you learn from this study?

I think we've given ourselves a lot of confidence in our biostatistical powering and in the design and in our teams and the site execution of this study. And I think that we will have important 6-month readouts coming.

In Q4, we'll have open-label data from the REVEAL-1 cohort. And in Q1, we'll be able to report these 45 patients, randomized patients' 6-month data.

And so we look forward to being able to elaborate that profile in our upcoming milestones.

Congrats on the data. Can we touch up on three points, if I may.

First, the data is obviously very unique and very intriguing at month 3. Can you speak to the relevance of what we see on weight gain through month 3 and the implications on a longer follow-up?

Number one. Number two, there's some standard error data that's disclosed here.

If you try to back out the implied standard deviation using the ends we do know, could you just speak to sort of the standard deviation around the data points being shown and if there's any outlier effect driving that? And then finally, look, the expectations were that this may result in half the weight gain as the tirzepatide arm.

And clearly, we exceeded way beyond that, not only is it flat, it's actually down. I guess what is the implication for -- what's the true positioning in terms of treatment?

Is it for maintenance only? Or would you consider optionality more upfront as well?

Thank you, Umer. Let's tackle those one by one.

So you asked about weight gain through 3 months. In this study, we specifically randomized patients who had achieved meaningful weight loss on tirzepatide.

The average weight loss was 40 pounds. And we're seeing that these patients, within 3 months, when they stop tirzepatide; are regaining nearly 10% of their body weight.

That's a new data point, and I think it's an important contribution to the field because I think it speaks to the magnitude of the unmet need. When you have 10 million people or more on a GLP-1, more than half of them are going to stop within a year.

This is the kind of weight regain that you may reasonably expect in those who most successfully lose weight in the first place. Imagine how frustrating that is for a patient.

On the other hand, what we are seeing is not only weight maintenance, but actually some incremental weight loss. That's a highly compelling observation.

The treatment difference is substantial in a short amount of time. And the read-through to 6 months for what you would expect the sham arm to continue to gain weight because that is what we have seen in prior clinical studies of GLP-1 withdrawal.

You would also reasonably expect the Revita arm to be able to continue to maintain the weight loss that we are seeing because 3-month results have historically been very predictive of 6-, 12- and 24-month experience in our prior clinical studies. So obviously, thank you for saying it's unique and very intriguing.

We agree. We also think that this portends very well for what we hope to see in the future.

Your second question on standard deviation and outliers. The fact is that when you stop tirzepatide, standard deviation arms are very broad.

You look at the SURMOUNT-4 study. I think it's supplementary Appendix 2.

It is very clear how broad that is. I would actually point you to how tight our effect size is with the number of patients that we're looking at relative to the expected extraordinarily broad splay that one would normally expect from stopping trazepatide in the first place.

That was a concern that we had, had going into the study. Now for both REVEAL open label and our randomized data, we're actually feeling quite encouraged about standard deviations.

And if I think about our biostatistical powering for the pivotal, these standard deviations are lower than what we were planning for, and that also portends well for the powering assumptions in the full pivotal. Third, you asked me about the magnitude of effect and its implications.

We feel incredibly encouraged for what this means for what Revita can do in obesity. We think of this not just for weight loss maintenance, but also induction of weight loss in the first place, which we've seen in type 2 diabetes, we would be eager to see in an obese population as well.

We think of this as having a GLP-1 independent mechanism of action, which means that you can use it as a stand-alone therapy or in conjunction with GLP-1s. And so when you think about induction, maintenance, stand-alone or combination with pharmacology, I think what we're setting up is a true potential backbone therapy, one that offers the unique differentiating characteristic of being able to potentially offer a durable metabolic reset by fixing the underlying physiology for the very first time in obesity.

We think that it's incredibly powerful. We think that the market does not yet appreciate how potentially impactful this is for the entire disease category, especially when you take into consideration how scalable this technique actually is.

I'll add my congrats on the data really, really exciting. I guess one question, thinking ahead to the 6-month data that will be coming, I believe we're expecting DEXA results.

So obviously, the weight loss and maintenance data you showed today is really exciting. But can you speak to how we should be thinking about DEXA data?

And any other kind of supportive endpoints that will be coming in the next update? And how we should be thinking about that?

Open-label data -- the next major update is going to be 6-month open-label data from the REVEAL cohort in Q4. And we will also have 6-month randomized data from this REMAIN midpoint.

There is an optional DEXA scan that patients can undergo in the midpoint and in the pivotal cohorts. And we will have -- we will also have metabolic assessments that we will be able to share on glucose, insulin and cardiovascular risk factors.

So over the course of time, you're going to see a further elaboration of what is already a very compelling signal where today's emphasis is really on how potent Revita may be in the primary endpoint for the core pivotal studies' objectives.

Awesome. That's helpful.

And then just to go back to some of the commercial comments you made, which were helpful. I guess, should we all be thinking about kind of the initial market opportunity here as those patients who are already going in for an endoscopy and kind of getting that call from the docs to stop the GLP-1s, and that's the kind of initial call point?

Or are patients going to be seeing commercials and calling endoscopy centers themselves to try to schedule this? Just kind of help us understand that a little bit, though I appreciate it's still early.

Yes. So absolutely, what we are hearing from GI physicians is that a substantial fraction of patients who are coming in for endoscopies are already on a GLP-1 and already being asked to stop their GLP-1s prior.

Some of the physicians with whom we're working are saying, we're going to offer this to every single patient who's coming in for an endoscopy, and that's why that 800,000 number is so compelling. I have another new data point to share, which is, as you know, we signed a letter of intent with Bariendo earlier in the summer.

And one of the physicians involved in Bariendo told us that when they run an ad in a community for their bariatric and metabolic services, somewhere between 50% and 80% of the people who respond to that ad are on a GLP-1 and looking for an off-ramp. And what that suggests to us is that direct-to-consumer advertising could actually be a very efficient way in order to build upon the practice that already exists within the GI practices themselves.

And I don't want to ignore the fact that primary care physicians who are actually managing the condition, the single biggest question they're getting from patients is, "When can I stop taking the GLP-1?" And we have found that they are incredibly receptive to the idea that a durable metabolic reset could be a very compelling treatment alternative because they themselves know patients don't want to be on medicines for the rest of their life to control their weight.

So we think that all three are viable channels. We point out that 800,000 number because it's such a huge opportunity that does not require 1 iota of change in human behavior from what they're already currently doing.

Given you'd be in a position to file a PMA second half next year, potentially data supportive here, I'm wondering what's most critical in your view, in terms of the ultimate 6 months, in terms of really bolstering more of an upside case, in your view, on the peak revenue potential here? Is it the spread of drug and sham arm or I guess, like coming off of trazepatide arm versus Revita, I should say, and/or the importance of just length and durability of benefit?

I'm just kind of wondering if you can revisit some of those measures. As you kind of think about filing, what really would support potentially blockbuster plus revenue opportunity?

Well, I think that there's likely three things, Jason, that would drive that. Number one is the magnitude of the treatment effect.

We believe we'll have a huge market opportunity if we simply blunt the rate of weight regain by 50%. Though we are seeing something much more impressive than that here, doesn't change the fact that that's what the market needs for this to be an extraordinary opportunity.

Obviously, the bigger the treatment delta, the more impressive that will be. We will also have 12-month data in the label, we would anticipate.

And as a result, like the strength of that durability signal would also support upside scenarios. And the third, I would say, are the ancillary data that Whitney asked about.

What are -- what's happening to the risk of the development of diabetes? As you saw here, there are 40% to 50% of these individuals are prediabetic, but most of those are undiagnosed prediabetic.

So bolstering the cardiometabolic profile around the benefits of being able to maintain weight versus those who discontinue and lose those benefits very rapidly as we know, coupled with potential body composition sort of benefits of not just become -- regaining fat mass and continuing to lose the lean mass as we expect is occurring in people who stop GLP-1s; I think that sort of ancillary set of benefits would also support a very -- like very compelling clinical and medical argument around what we are offering here.

Okay. And one just follow-up for me, the single SAE, the cholecystitis that was adjudicated not related to device or procedure.

Just can you talk a little bit about how that was adjudicated?

Yes. There's an independent clinical endpoint committee that adjudicated this case, occurred 65 days or so after the randomization procedure.

And the fact is, if you look at the demographics of those who are enrolled in the study, largely -- mostly women who are in their 40s and who are overweight and not yet menopausal, those are the four biggest risk factors for gallbladder disease anyway. So you're going to -- we're going to have some amount of gallbladder disease in patients as we enroll more of them.

This demographic is exactly those people who are already predisposed. And given the time disparity between the Revita procedure, mucosal healing and the absence of any symptoms through the randomization to when the cholecystitis appeared, this was adjudicated independently as unrelated.

Congratulations on the data. A couple of questions on the trial itself.

So first, do you have information as to how long patients were previously on tirzepatide or what the range was? And how that might impact interpretation of the data?

Sure. So as a reminder, this study took GLP-1-naive individuals.

And we initiated them on tirzepatide, titrated them to 15% total body weight loss, and it took between 16 weeks and 26 weeks for these 45 individuals to get to 15% weight loss.

Perfect. Okay.

And then I was curious if you could just remind because I know it does not definitely -- it does not impact the sham data, but can you describe the sham procedure?

These patients are only randomized after the catheter is inserted into the body and the catheter dwells. In the sham procedure, the catheters left there for a fixed duration that mimics the total length of the procedure.

And the GI physician who performs this procedure, never sees the patient again once they are wheeled out of the room and into the recovery room. And so this is a true double blind.

And I think it's about as rigorous as sham as humanly possible.

Great. That's fantastic.

I appreciate that clarity again. And then lastly, for the actual procedure, and the time of doctor assessments, are there any scheduled visits or follow-up exams with the doctor before the final primary endpoint time point?

There are visits -- in-office visits at 1 month and 3 months and then the next in-office visit is 6 months, which is the primary endpoint.

Congratulations on the very, very nice data. Just trying to sort of tease out the effects that we're seeing here.

And so I was kind of curious that alongside the weight loss improvements, you mentioned that you're also going to be collecting data on glucose and insulin. But I was also curious if there is any -- going to be any analysis on, say, biomarkers, thinking specifically like a GLP-1, PYY, maybe ghrelin?

Are there anything that could sort of support the actual benefits, this weight loss or even the weight maintenance that you're seeing? Yes.

We've tested these hormones in the past in prior studies and have not seen changes that correlate with the fact. And so we don't see serum levels of these hormones as being a driving mechanism here.

We are collecting the blood for this type of an analysis, and we'll likely do that as a sub-study in the future.

Okay. And then also sort of just thinking in terms of -- have you been -- or are there plans or are you incorporating PROs into this just with the data we're seeing both in your REVEAL, but also now in the REMAIN?

It looks like, in my opinion, that the patients might be feeling a lot better or having a very positive result. So I was just curious, how that data or those -- that perception, whatever it may be from the patients may be being collected?

We're collecting and tabulating PRO data. We look forward to sharing that when it's available.

Should we expect that a 6-month readout for REMAIN? Or is that only in the pivotal?

Let me get back to you on that. I'm quite confident we're collecting them in the midpoint cohort as well.

Okay. And then lastly, if I may.

You obviously have a very nice cadence here between REVEAL and REMAIN between fourth quarter than first quarter, both at 6 months and then longer term, the 1 year. So I'm just trying to -- how should investors and people looking at the data sort of going between an open label and then your RCT, how should we sort of be trying to read through from REVEAL to REMAIN and then eventually to the pivotal?

Well, when we showed 3-month data in June from the open-label cohort, it was highly intriguing, and investors -- some investors got excited about it. And I think some remained skeptical because they wanted to see randomized data.

Now that we've shown randomized data and the Revita arm is performing as well or better than the open-label cohort, I think we would then look at the 6-month open-label data that will be coming and view it through the lens of what we have just seen. I hope that what all of this serves to provide are complementary pieces of evidence around the potential effect for Revita in both a real-world registry-type setting, which is what the REVEAL-1 open-label cohort is, as well as on controlled conditions.

And my view that the market, payers and the other stakeholders can benefit from seeing the totality of all of that evidence because they are slightly [indiscernible] to one another in their design. But the consistency of what we are seeing so far clearly gives us a lot of encouragement as we go into the upcoming milestones.

And my last point would be that by this time next year, with 1 year open label data from REVEAL and 6-month randomized data from the pivotal cohort, one could feel reasonably confident that the entire clinical profile for Revita in weight maintenance will have been substantially derisked and can take that to also then think about the fact that we have breakthrough device designation, which portends regulatory sort of timelines and expectations and the potential for reimbursement through the TCET pathway at CMS. So we're very excited for what's to come in the year ahead.

We're very excited that we announced this morning that we project having cash through all of these major milestones that we're talking about today. So exciting time with a lot of fantastic catalysts in the quarters ahead.

Thank you. Thanks, everyone.

You've seen the signal, you've seen the safety profile, you've seen the potential scalability and the enthusiasm of patients and sites to enroll our studies. Our next steps are clear with Revita: To deliver 6-month midpoint cohort data, to complete the pivotal cohort randomizations early in 2026, drive to pivotal cohort top line data and potential PMA submission next year.

We believe that Revita has an extraordinary potential to be a new backbone therapy in obesity care, and we look forward to updating you on all of our progress in the coming months.