Good afternoon and welcome to the Fractal Health Third Quarter 2026 Financial Results and Business Update Call. As a reminder, this conference call is being recorded. At this time, all participants are in a listen-only mode. There will be a question and answer session following management's prepared remarks. I will now turn the call over to Brian Luque, Head of Investor Relations and Corporate Development at Fractal. Brian, you may 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.fractal.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. Before we begin, one change to our format. For the first time, we invited all of our shareholders to submit and vote on questions for management through Say by Robinhood. After our prepared remarks, I will read a selection of the most voted shareholder questions, and then the operator will open the line to our covering analysts. Thank you to everyone who took part. 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 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.

Good afternoon, everyone. Nearly 30 million Americans are now on GLP-1 therapy. Approximately 1 million are discontinuing GLP-1s each month. Those who take GLP-1s, only one in 12 Americans remain on them for obesity at the end of three years. What happens for the 11 out of 12 who stop? On average, 85% of patients regain weight, and roughly two-thirds of the weight comes back within a year. That is a systemic pattern driven by biology, not an individual failure of willpower, and it doesn't have to be this way. So why does the weight come back? We believe the answer is in the gut. Modern unhealthy diets accelerate cellular aging in the gut. In plain terms, those changes make us more prone to obesity, and the aging gut may retain a metabolic memory that perpetuates disease. GLP-1 medicines have proven that dramatic weight loss is possible, but they neither reverse the underlying cellular aging causing obesity nor regenerate a healthy gut. They leave the underlying problem untouched. Revita aims to do both. It is designed to reset the gut's metabolic memory as a one-time outpatient procedure designed to oblate the damaged, unhealthy lining of the duodenum to allow healthier tissue to regenerate in its place. LASIK for obesity. It means the gut is now working with, not against, a patient's weight loss program. This means a potential for better overall health and weight loss that can actually last even after the drugs are stopped. Last month, we put that idea through the most rigorous stress test we could conceive, Remain-1, in which patients were driven to achieve rapid and profound weight loss and then stopped high-dose triseptide outright. It's the most extreme example of what could happen in the real world, and the study met its six-month co-primary endpoint with high statistical significance. Today, I want to take you through three things. Number one, what the Remain-1 top line showed. Why we believe it is clinically meaningful and what to expect next as we look to complete the study in Q1, 2027. Number two, why the market is ready for ReVita. And number three, how we have rebuilt Fractal around it. Then Lara will take you through the quarter. I will close on three milestones in front of us. Submitting our de novo marketing application later this quarter, 12-month co-primary and key secondary endpoints in the first quarter of 2027, and clarity on the CMS rapid reimbursement rules. all value accretive milestones funded with the cash we have on hand. Let me take each in turn. What did Remain One top line show? We designed Remain One to provide a rapid and clean assessment of Revita's safety and efficacy in the post-GLP-1 weight maintenance setting. Adults with obesity who had never taken a GLP-1 started terzepatide, stayed on it until they had lost at least 15% of their body weight. On average, they lost 18.3% over about 25 weeks, and about half reached the maximum 15 milligram dose. Then the drug was stopped and participants were randomized two to one to Revita or to a sham procedure, double-blind. 308 participants make up the modified intention to treat population. The study met its six-month co-primary endpoint with high statistical significance, p-value of 0.0023. Revita participants kept about 80% of the weight they had lost on the triseptide, and whichever way we analyzed it across primary and every pre-specified sensitivity analysis, the result was highly statistically significant, with two to three zeros in the p-value. If anything, we believe the comparison with sham is conservative. Sham participants were about three times as likely as Revita participants to restart an anti-obesity medication, which potentially masks the true effect of Revita. Two findings I want you to remember. First, the effect grew over time. The gap between Ravida and sham widened at every visit from month one to three to six and nearly doubled between months three and six. In our pilot, Ravida patients leveled off at about 80% of their weight loss retained at one year, and so far the pivotal is tracking that experience. Second, what this means for an individual patient. One in three Ravida participants were weight stable or had lost more weight six months after stopping trisepatide. Nearly half kept at least 80% of their weight loss. And when we apply the method for our 12-month responder endpoint at six months as a post hoc analysis, more than 97% of Ravida participants maintained clinically meaningful weight loss at one year against a performance goal of greater than 50%. The formal test of that second co-primary endpoint will come with our 12-month data in the first quarter of 2027. We also continue to see a dose response with ablation length. In our pilot, the benefit was clearest above 14 centimeters. With a much larger study, we now have the numbers and granularity to see it more precisely. In a post-hoc analysis, separation from sham begins at a dose as low as 12 centimeters and progressively better with a longer ablation for the full length of the duodenum or roughly 20 centimeters. Our best performing patients received a full treatment of 20 centimeters or more, and they achieved less than half the regain of sham. Remain One contributes not only the evidence to support our plan de novo submission later this quarter, but also the evidence to inform how to train physicians to perform the procedure after approval for maximum effect. Each additional two centimeters takes about two centimeters, and physicians lengthen their ablations as they gained experience in the study. With the six-month and 12-month data, we will have adequate information to define the appropriate treatment length for real-world implementation. And there's an added benefit to the dose response we are observing. Given the novelty of the duodenum as a target, dose response builds credibility in target validation, something we are hearing from physicians over and over again. On safety, the profile was what we have come to expect from Roveda. There were no device or procedure related serious adverse events, no deaths, no unanticipated adverse device effects. Related events were mostly mild and the vast majority of them occurred only on the day of the procedure. So the next clinical milestone for Remain 1 is clear. In the first quarter of 2027, we expect top line 12 month data from the second co-primary endpoint. If both co-primary endpoints are met, Our key secondary endpoints, including complete ablation and higher run and weight loss, will then be formally tested in sequence. Here is what success looks like at 12 months. First, we meet the second co-primary endpoint, which is the pre-specified performance goal. Based on what we see at six months, we're highly confident in that result. Second, at longer ablation lengths, we want to see even greater effects as we showed at six months. We hope to see the Revita arm with a complete treatment maintain a majority of its weight loss at one year. The physicians we've been talking to and our patient market research tells us that a full ablation should be the expected standard procedure for Ravida if it is authorized. Now let's step out of the data and into the doctor's office. In a consumer market, physicians will not talk to patients about placebo-adjusted differences. They will say, here is what you can expect to keep. Remain one top line clearly demonstrated that patients have the potential to retain The majority of their hard-won weight loss with a low risk of serious side effects. Now let's turn to why the market is ready for Revita. At our commercial strategy day in September, we laid out why we see Revita's launch as market activation, not market creation. Our commercial model is a targeted and efficient launch at bariatric and metabolic centers of excellence. The patients, the interventional physicians and surgeons, the procedure rooms, and the payer precedent already exist. What is missing is a durable off-ramp. Each year, roughly 4 million Americans stop a GLP-1 after losing at least 15% of their body weight and fall within the BMI range we studied. That is a population that remain one enrolled. Those patients are concentrated in ASMBS Centers of Excellence that we can name. There are about 1,000 accredited bariatric centers in the United States. Our launch plan focuses on the top 100 to 200 of them, many of them sites that we already know from our clinical program. Each of those centers already sees more than 2,000 GLP-1 patients a year, and we model 250 to 500 Revita procedures per center per year at maturity, well within each center's capacity. And the metabolic interventionalist physicians in those centers already have the skills and the enthusiasm for procedures like Revita. In Remain 1, a half day of training and about four proctored cases brought them to proficiency. That, backed by a capital efficient center of excellence model, is why we believe a commercial team of tens of people, not hundreds, can support a launch. In 2025, before our pivotal data, we commissioned third party market research across roughly 750 patients, prescribers, and hospital stakeholders. Three findings stand out from that market research. First, patients understand the risks of discontinuation very well. Nearly 8 in 10 patients were both already aware of and very concerned about regaining weight after stopping a GLP-1. Over 80% ranked a one-time procedure that lets them stop their GLP-1 without regaining weight as among the features that mattered most to them. The patients most interested were those who are currently on a GLP-1. Amazingly, despite the very well-known benefits of long-term GLP-1 treatment, one in three surveyed GLP-1 users would prefer to stop taking their GLP-1 and undergo a hypothetical endoscopic procedure, then continue staying on their drug. And prescribers told us the evidence that moves them most is what happens to the patients in the Revita arm, which is exactly how Remain-1 reads out. Second, patients want to make this decision with their doctor. and that is good news for Revita. The metabolic interventionalists we are building our launch around already have these patients in their practices and are excited about offering them Revita if it is cleared. Third, the physicians who perform procedures are ready. Interventional practices in the research were highly interested in adopting Revita and their concerns centered on economics and validating outcomes, which is exactly what our reimbursement work and Remain One are designed to address. That is why our launch centers on metabolic interventionalists, the bariatric surgeons, and advanced endoscopists who already manage GLP-1 patients and already perform procedures. The independent physicians who joined our commercial strategy day and our data calls over the past several months told us this conversation is part of their practice day in and day out. One question that we often hear, do oral GLP-1s change this picture? We don't think so. What patients valued most was the ability to stop either a weekly injection or a daily pill. A daily pill may change how a patient takes a GLP-1. It may increase the number who started GLP-1, but it does not change their perspective on whether they want to stay on a GLP-1. Our view is simple. Every initiation, oral or injectable, is a potential future discontinuation risk for which an off-ramp is a needed treatment alternative. This brings me to reimbursement, where there are three components and all three have made significant headway in the past quarter. On coding, the AMA published Category 3 CPT Code 1122T on October 2nd, a dedicated code for the Revita procedure that will be effective January 1st, 2027. On payment, if Revita qualifies for CMS transitional pass-through payment, which we believe it will, that could help hospitals recover the catheter costs and their contribution margin during the early launch period. And on coverage, CMS has proposed RAPID, a new coverage pathway that could align Medicare coverage with FDA authorization for breakthrough devices. The open question for Revita is how devices like ours, with pivotal trials already underway, get to participate in RAPID. The response during the comment period was overwhelming. More than 160 comments were filed, nearly all of them supported an on-ramp including the major medical societies and the device industry associations, MDMA and AdvaMed. Several went further and named Revita specifically. ASGE and ASMBS pointed to Revita as an example of the devices for which CMS needs to find a solution. They were joined by a joint AGA and ASGE letter, the Obesity Action Coalition Patient Advocacy Group, and leading bariatric and endoscopic physicians writing on their own behalf. We expect to learn whether CMS adopts an on-ramp by early January. If Revita is included, it could offer a materially better coverage position than our base case assumes. And remember, the Medicare GLP-1 Bridge Program is expanding GLP-1 access for seniors through the end of 2027. A federal program is creating and time-limiting the exact population that Revita is designed to serve. The patients are there. The physicians are there. The payment pathway is taking shape. Revita is being built to be the missing piece. Now let's talk about how we have rebuilt Fractal around Revita. On October 21st, in consultation with our board, we decided to streamline the company's operations, workforce, and business to become hyper-focused on Revita's near-term objectives. The goal is to get through our upcoming clinical, regulatory, and early commercialization milestones as efficiently as possible. That meant reducing our workforce by approximately 45% and discontinuing internal development of our Rejuva gene therapy program. Given the current financing environment for biotech, it is our duty to adapt to the reality of the situation and we have. This was a painful thing to go through. These decisions affect colleagues who helped bring Revita to this point. I value each one and I'm grateful for everything they have done to bring Fractal to where it is today. And as these changes take effect and our pivotal study spending winds down, we expect our quarterly operating cash spending to fall by approximately half to approximately $8 million by the end of the second quarter of 2027. Our cash runway now extends into the second quarter of 2027 through our planned de novo submission and our 12-month pivotal data. We also added to our board this month welcoming Mike Wartell as an independent director. Michael brings extensive experience serving on public and private company boards, and we're glad to have his perspective as we execute on the milestones ahead. I also want to thank Jay Caplan, our wonderful co-founder and former president, my dear friend, who's been instrumental in helping build this company. Jay retired from his executive roles at the end of October. The result of all of this is a smaller, more efficient, more focused company with one priority, delivering on Revita's near-term milestones. Lara?

Thank you, Harith. The story of this quarter is discipline. Lower operating expenses a day and a clear path to cutting our quarterly operating cash spending roughly in half. Research and development expenses were $12.5 million for the third quarter of 2026, compared with $17.5 million for the same period in 2025. The decrease of $5 million was primarily related to reduce spending on our Revita and Rejuva programs, as well as lower personal related expenses. SG&A expenses were $6.2 million for the quarter, compared with $5.2 million for the same period in 2025. The increase of $1 million was primarily driven by higher personnel related and stock compensation expenses. We reported a net loss of $14.2 million for the third quarter of 2026 compared with a net loss of $45.6 million for the same period in 2025. The $31.5 million decrease was driven by a $25.7 million favorable change in the non-cash fair value of our warrant liabilities and a $4 million reduction in operating expenses with smaller movements in the fair value of notes payable and interest income. Adjusted EBITDA was negative $16 million for the quarter compared with negative $20.8 million in the third quarter of 2025, a $4.8 million improvement driven by reduced operating expenses excluding stock compensation. As of September 30, 2026, we had $31.5 million in cash and cash equivalents. I want to draw your attention to one point on our run rate. Cash used in operations was just below $16 million in the third quarter, which still reflects remain one pivotal cohort spending and our cost structure before the reprioritization. As cost reductions take effect and pivotal expenditures decline, we expect quarterly operating cash spending to be reduced by approximately 50% to approximately $8 million by the end of the second quarter of 2027. We expect to incur approximately $2 million in severance and related charges, the majority in the fourth quarter. Based on our current operating plan and anticipated expense reduction, we believe our cash position will be sufficient to fund operations into the second quarter of 2027 through our Plans de Novo submissions and the anticipated top-line one-year data from the Remain One Pivotal cohort. With that, I'll turn it back to Harith.

Thank you, Lara. And let me close where I started. Revita is designed to reset the gut's metabolic memory. Remain One met its six-month co-primary endpoint with high statistical significance in the most rigorous stress test that we could conceive. The patients and physicians are there and the payment pathway is taking shape. We have rebuilt Fractal around Revita with the runway to get through the milestones directly in front of us. Over the next several months, there are three milestones I want you to be focused on. First is the submission of our de novo marketing application, which we plan to begin in the late fourth quarter of 2026. Second, our 12-month pivotal data in the first quarter of 2027, including the second co-primary endpoint, key secondary endpoints, and dose response analyses. Success there means meeting the regulatory performance goal and roughly half the regain of sham at full ablation length. Third, clarity on the CMS rapid reimbursement rule. We expect to learn by Q1 whether CMS adopts an on-ramp for devices like Revita that have pivotal trials already underway and we are optimistic that they will find such a path. Beyond those, we see a potential FDA marketing authorization in late 2027 and a potential US commercial launch in early 2028. I want to thank the patients in Remain One who have trusted us with their health and their persistence, the investigators and operators who have executed this trial with real skill, our employees, including the colleagues leaving us this quarter, whose focus through an unusually demanding stretch has been exceptional, and I want to thank our shareholders, including the many individual investors who sent us questions for the very first time, whose conviction in the science makes all of it possible. This is the moment Fractal was built for. We've never been more focused. on delivering on what comes next.

Brian, let's start with those questions. Thanks, Harith. We'll begin with questions submitted by our shareholders through Save by Robinhood. I'll read a selection of the most voted questions, combining a few that overlap. The first question is, what concrete steps are the board and management taking to restore credibility with investors, including institutional investors?

Thank you for asking directly. Credibility is earned by doing what we say we will do, and I would point to four steps. First, the data. Remain one met at six-month co-primary endpoint in a randomized double-blinded sham-controlled study with high statistical significance. Second, discipline. With our board, we made difficult decisions last month to focus a company entirely on Revita and to put us on a path to cut quarterly operating cash spending by approximately half. Third, governance. This month, we added Mike Wartell to our board as an independent director. And fourth, we remain committed to keeping a continuous dialogue with our institutional and retail investors alike. From here, we expect to be judged on execution, de novo submission, 12-month data, and clarity on rapid.

Great. The next question combines a few on funding. How does the company plan to fund its upcoming milestones, and are you exploring strategic partnerships, licensing agreements, or a potential acquisition?

We ended the quarter with $31.5 million in cash and cash equivalents. Based on our current operating plan, we believe that that is sufficient to fund operations into the second quarter of 2027 through our planned NANOVA submission and the 12-month Remain One data. The reprioritization we announced in October is expected to reduce quarterly operating cash spending by approximately 50% to approximately $8 million by the end of the second quarter of 2027. So based on our current operating plans, the milestones Harith described are funded with the cash we have on hand. Beyond those milestones, we will need additional capital to bring Revita to market, and we will weigh every option with shareholder value in mind. On the strategic side, we do not comment on specific discussions and we would update you only if there was something definitive to report. What I can say is that every milestone we deliver potentially expands our options.

Great, thank you. And the last shareholder question is about ablation length. Your data showed better results with longer ablations. What training or procedural steps are you taking patients in the real-world practice consistently receive a full length of treatment or 20 plus centimeters?

This is a great question. The answer is quite simple, actually. In our analyses, we saw a better treatment effect at longer ablation lengths, like what we had seen in prior studies, and patients who reached 20 centimeters in a post hoc analysis saw the greatest effect with no associated safety signal observed. Physicians in Remain 1 reached that length with the current device Each additional two centimeters takes about two minutes. And these findings inform the procedural parameters that we've proposed to the FDA. And if Ravida is approved, we'll also inform our physician training program for launch.

Great. That concludes the shareholder questions. Thank you to everyone who submitted. Operator, please open the line for our analysts.

Thank you. At this time, we will conduct a question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile our Q&A roster. And our first question will come from the line of Angela Sheehan of Canaccord Genuity. Your line is now open.

Hey guys, thank you for taking our questions. This is Angela on for Whitney. Question on the Medicare patient population. It sounds like that population can really represent a significant portion of Revita patients given the bridge program ending at the end of 27. And then since you're targeting the top 10 to 20% of high volume accredited metabolic and bariatric centers, can you maybe share What proportion of patients at those centers are currently Medicare patients?

Sure. Thank you, Angela, for the question. I would say that, yes, we are planning an early launch predicated on Medicare patients. The question that you're asking is complicated because until about six months ago, relatively few patients were Medicare patients. But in our conversations in the last several weeks alone, what we are observing is that every one of our centers with whom we're in dialogue are seeing a rapid increase in the number of Medicare patients who are specifically seeking GLP-1s through this bridge program. We heard earlier in the quarter that from David Ricks, the CEO of Eli Lilly, that 700,000 patients had joined the GLP-1 bridge program across the United States. that number is a fraction of what Medicare anticipates will be in the United States. It'll be roughly four to five million people on the GLP-1 bridge by around this time next year. So if you assume that there's roughly 30 million people on GLP-1 today, and let's say that's a relatively steady state number, it's gonna grow by about four to five million of GLP-1 patients who are from the bridge program alone. That's our expectation.

Got it. Thank you. If I could just follow up quickly with another question that piggybacks off of one of the shareholder questions I was asked. Since you had seen greater lengths of ablation results and greater efficacy, I guess, do you expect physicians to potentially require longer training than what was previously estimated since they might have to play a longer length?

Thank you. Well, before beginning Remain One, we believe that the length of duodenal ablation could be an important determinant of treatment effect. And as you saw from our midpoint study and our six-month data, we've observed an encouraging relationship between ablation length and efficacy. In our exploratory analyses, patients receiving longer ablation lengths did experience greater reduction in weight regain. And the practical implication is that if longer treatment lengths are truly associated with greater benefit, and we'll see that 12-month data soon, We believe that physicians can and will be trained to deliver those treatments consistently. Remember, each additional two centimeters of ablation adds approximately two minutes to the procedure. We're not talking about an entirely different intervention or a fundamentally different skill set. We're talking about optimizing the extent of treatment within a standardized endoscopic procedure with our existing tools and skills. We've seen physicians improve their ability to deliver longer treatments as they gain experience. And when you're treating more tissue or delivering a higher dose, the therapeutic window and safety matters. So I just want to reiterate, importantly, we have not observed a safety signal suggesting that longer ablation lengths are associated with any additional risk of serious adverse events in the data that we've evaluated to date.

Thank you. One moment for our next question. Our next question will come from the line of Mike DeFiore of Evercore. Your line is open, Mike.

Hey, guys. Thanks so much for taking my questions. Two for me. One is regarding the potential Class 2 classification of Ravida. Obviously, the final pathway decision follows a review of the complete safety data set, but Regarding the two events in one Revita patient that were deemed possibly related to the device or procedure, which included GI hemorrhage and acute blood loss anemia, how do you expect the FDA to treat these possibly related events when it determines the class?

So I can't speak for the FDA, but I can speak to this adverse event that you're mentioning. So just for those who may be new to the story, there was one patient who experienced possibly and others. This is an individual who was on two different nonsteroidal anti-inflammatory drugs at the same time, which is contraindicated for a different indication totally unrelated to Ravida or the disease that we are targeting here. And we know that NSAIDs carry a risk of GI bleed. This patient also had two endoscopies performed during the active bleeding episode and no bleeding source was identified in the duodenum despite an active effort to try to find one and no intervention was ultimately performed. It's only because the person was in the study that we believe that this was classified as possibly. We believe that the study team did everything they could to determine whether there was a cause from the ablation, and none was found. So we do not think this is going to change anyone's perception of Ravida's safety profile.

Very helpful, Harith. Just one quick follow-up. What indication statement are you proposing? Is it tied to prior weight loss of at least 15% and a certain BMI window, or does it cover a discontinuation of any GLT-1? Thank you.

Right. We haven't yet finalized that, so I don't want to jump ahead. But I think it's reasonable to say that 15% was selected in our trial because we believe that that would be a large enough weight loss to be able to discern a treatment effect. And we think that translates to Revita providing potential benefit in people who have achieved clinically meaningful weight loss on any GLP-1. Again, we used Terzepatide in the trial. mainly for study homogeneity purposes, we believe that that will not be a limitation on the label itself.

Got it.

Thank you.

A 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 for Jason. Thanks for taking our questions. My first one is, What are the remaining steps or gating factors, if any, for the U.S. filing in late 2026? Have you met with the FDA after the paper, the readout, the six-month readout, or would you need to meet with the FDA before the filing? And if that's the case, what sort of discussions or feedback are you aiming to get at the meeting?

We have not met with the FDA. We've got a lot of feedback during the course of the year in interactive discussions because we are a breakthrough device. We do not anticipate any specific FDA feedback required beginning before our submission. We are working on compiling the elements of our submission right now. I think that the gating item will clearly be, I would say, that you can reasonably expect that When the second co-primary endpoint from remain one will read out in the first quarter of 2027, those data will also be an important part of completing the clinical evidence package supporting our application. So while we've been preparing the design, the manufacturing, the other technical components of our de novo application for quite some time, our plan is to advance those components in the fourth quarter of this year. We are targeting the completion with the full clinical package in the first quarter of 2027.

Got it. And my follow-up question is sort of maybe perhaps thinking about further down the line. As we step back, you know, a couple of the observations you have made up from the data is that, you know, longer ablation length leads to better efficacy and also potentially bigger the weight loss prior to GOP when discontinuation, the better the efficacy. So as you think about further down the line as there are potentially more novel GLP-1 therapies, maybe more potent therapies, what are the opportunities to sort of doing post-marketing studies to sort of revisit Revitia potential as the treatment landscape evolves?

Well, we actually think one of the interesting and underappreciated elements of this story is that as the drug manufacturers get better at developing more potent agents that deliver more weight loss more rapidly, the need for a off-ramp actually only grows. Let's take some of the more recent drugs that are delivering even more profound weight loss than those that are already approved. We have clearly heard from clinical trial sites that when these studies end, after patients have lost 40, 45% of their body weight and then they no longer have access to the medicines, they are so hungry they are eating everything in their pantry. We've heard from one clinical investigator that they have had patients who've eaten their dog food and their cat food when they ran out of food in the pantry because when you lose that much weight and then the medicine is taken away from you, the body's physiologic drive to eat and regain weight is so profound. I believe the need for a manner to be able to blunt that regain is going to be even more important as the drugs get better.

Okay, great. Thank you for taking our questions.

One moment for our next question. Our next question comes from the line of Chris Knickerbocker of Craig Halem. Your line is now open.

Good afternoon, guys. Thanks for taking the questions. One from me, following the restructuring and the actions you've taken to extend runway, just trying to get a sense for how you're thinking about the initial go-to-market and how that thinking may have changed. Question being, how lean do you think you can be initially and still effectively target those first 50 to 100 potential centers of excellence? And whether you just want to discuss any update to how you're seeing commercial infrastructure

We made substantial reductions to our workforce, it is true, but it's also important to understand that we've also fundamentally focused our company on the highest value activities as our needs have evolved. Number one, with the discontinuing our Rejuva program. Number two, as our clinical trial is coming to a close, the amount of money and effort spent on that is reducing. And then number three, as we have been finalizing our design and manufacturing modules, a lot of the work required in order to be able to prepare that device to be able to launch has been completed. And so while we've made those changes, and those changes have allowed us to reduce our spending and concentrating our resources. That's what's allowed our operating cash spending to decline in the manner that it has. But we're not trying to execute the same operating plan with half the resources. We're just executing a much more focused plan. And when we think about commercialization, remember, we're not planning a broad, highly resource-intensive launch from day one. As we outlined in our September Investor Day, our strategy is to begin with a very targeted group of established bariatric and metabolic centers of excellence. They already have the patients, physicians, and procedural infrastructure that Revita would need. And that does give us the ongoing opportunity, subject to authorization and reimbursement and financing, to continue to be able to demonstrate early commercial adoption as we have already laid out. So we remain committed to being able to move towards the plan that we have laid out for you before. Understood. Thanks.

Thank you. One moment for our next question. Our next question will be coming from the line of Jeffrey Cohen of Leidenberg, Bauman & Company, Inc. Your line is now open.

Good afternoon. Thanks for taking our questions. Just one from everyone. Laura, as you talked about the one-timers on severance for Q4, could you give us a sense of SG&A versus R&D and then give us also a sense of how the spend on SG&A and R&D plays out over the next few quarters?

Look, we haven't given any guidance actually on the split between SG&A and R&D. I would just say that we have reduced As Therese said, we focused throughout the entire company and reprioritized. And the 2 million, it will be spread roughly in the same proportions that you could expect it to be with SG&A and R&D that we have today. And we'll give more information as we can. What we can say is that we have reduced our burn and expect it to come down to approximately 50% or 8 million by the end of Q2 2027. Okay, perfect.

Thanks for taking our question.

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

Thank you, everyone. Thank you to the shareholders who sent in questions for the first time. Three things to watch from here. Plan de novo submission, clarity on the CMS rapid rule, top line 12-month data from the Remain One Pivotal cohort in the first quarter of 2027. We are funded through each of them. We look forward to updating you as we deliver. Thank you all.

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