Q4 2025 Fractyl Health Inc Earnings and Business Update Call

March 24, 2026

[Company Representative] (Fractyl Health): 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 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.

Speaker #1: Us on the call today are Dr. Harith Rajagopalan, Chief Executive Officer in 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.

Speaker #1: 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.

Speaker #1: Any forward-looking statements on the call are subject to substantial risks and uncertainties. We 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.

Speaker #1: It is now my pleasure to pass the call over to Harith.

Speaker #2: 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 six months, and approximately 15% within 12 months.

Harith Rajagopalan: 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 six 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. Rejuva is our smart GLP-1 platform targeting long-term metabolic remission from a single dose.

Speaker #2: 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.

Speaker #2: Revita is being built for that moment. For those of you who are new to the FRACTAL story, Revita is our lead asset. It's like LASIK for obesity.

Speaker #2: 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.

Speaker #2: 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.

Harith Rajagopalan: 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 six-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.

Speaker #2: I'd like to start by naming something directly. In January, we reported six-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.

Speaker #2: This clarity has strengthened our conviction in Revita and has helped us finalize a pivotal study's key design elements to ensure we are set up for regulatory and commercial success.

Speaker #2: 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.

Harith Rajagopalan: 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 four 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. 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 control study that enrolled 45 patients with obesity who were GLP-1 naïve. They were started on tirzepatide to achieve at least 15% total body weight loss and then randomized 2 to 1 to Revita versus sham.

Speaker #2: Let me walk you through four key pillars that give us conviction in the opportunity in front of us. Number one, the clinical signal is real.

Speaker #2: 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.

Speaker #2: Now let's start by discussing the clinical signal. You will recall that the midpoint cohort was a pilot randomized double-blind sham control study that enrolled 45 patients with obesity who were GLP-1 naive.

Speaker #2: They were started on tirzepatide to achieve at least 15% total body weight loss and then randomized two-to-one 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 standalone efficacy study.

Harith Rajagopalan: 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 standalone 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.

Speaker #2: Nonetheless, the six-month midpoint cohort data did not look as strong as the three-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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Harith Rajagopalan: This is a strong positive signal for the Revita mechanism of action and for the potential success of a 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 lengths, from 9cm in the first-in-human to over 16cm on average in REMAIN-1, and have seen greater potency in our studies without compromising patient safety. Because of this experience, our pivotal study already pre-specifies an ablation length dose response secondary endpoint.

Speaker #2: 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.

Speaker #2: Since that time, we have been systematically optimizing the procedure profile across successive clinical studies to deliver longer ablation lengths—from 9 centimeters in the first-in-human to over 16 centimeters on average in REMAIN.

Speaker #2: And have seen greater potency in our studies without compromising patient safety. And because of this experience, our pivotal study already pre-specified an ablation length dose-response secondary endpoint.

Speaker #2: When we apply this dose-response analysis to the midpoint cohort of 45 patients, we observe a statistically significant p-value less than 0.05, indicating a monotonic and clear relationship between ablation length and weight maintenance treatment effect at six months.

Harith Rajagopalan: When we apply this dose response analysis to the midpoint cohort 45 patients, we observe 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 cm of ablation regained approximately half the weight of sham, whereas those individuals with sub-threshold 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.

Speaker #2: Participants who received more than 14 centimeters of ablation regained approximately half the weight of sham, whereas those individuals with sub-threshold ablation accounted for the apparent narrowing of treatment effect between month three and month six that we saw in our January data release.

Speaker #2: 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.

Speaker #2: The density of that cell population is distributed along the length of the duodenal mucosa. And duodenal dysfunction from high-fat, high-sugar diets extends along the length of the entire duodenum in animal models.

Harith Rajagopalan: The density of that cell population is distributed along the length of the duodenal mucosa, and duodenal dysfunction from high-fat, high-sugar diets 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 confirm. 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 aimed for an ablation of at least 10 centimeters but encouraged physicians to ablate more if they deemed it appropriate.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Based on our work in type 2 diabetes, we aimed for an ablation of at least 10 centimeters, but encouraged physicians to ablate more if they deemed it appropriate.

Speaker #2: 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.

Harith Rajagopalan: In the pivotal study, the mean and median ablation length are more than 16cm, 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 14cm of ablation, confirming procedural scalability and feasibility across diverse operators and patient anatomies. 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. Ablation dose is a specific, measurable, controllable, and standardizable metric for repeatable outcomes in a broad population. Having established ablation length as a key procedural driver of Revita's potency, let's turn to patient selection.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Harith Rajagopalan: 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. We designed REMAIN-1 with a greater than 15% total body weight loss threshold at run-in, specifically because we expected treatment effect to scale with the degree of pre-randomization weight loss. Midpoint cohort results at six months confirm this relationship. Participants with greater than 17.5% weight loss showed an early, sustained, and compounding separation from sham through six 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.

Speaker #2: So we designed REMAIN 1 with a greater-than-15% total body weight loss threshold at run-in, specifically because we expected the treatment effect to scale with the degree of pre-randomization weight loss.

Speaker #2: The midpoint cohort results at six months confirmed this relationship. Participants with greater than 17.5% weight loss showed an early, sustained, and compounding separation from sham through six months.

Speaker #2: 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.

Speaker #2: So, when we now consider the right dose in the right patient, we observe the signal to be strongest among participants with higher weight loss who received longer length of duodenal ablation.

Harith Rajagopalan: 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 lengths of duodenal ablation. In these individuals, Revita-treated patients experienced only 2.9% weight regain at six months compared to 9.9% in the sham arm, approximately a 70% reduction in post GLP-1 weight regain. Like ablation length, the treatment effects 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 six months. We believe this degree of weight loss maintenance will be highly compelling to key commercial stakeholders.

Speaker #2: And in these individuals, Revita-treated patients experienced only 2.9% weight regain at six months compared to 9.9% in the sham arm, representing approximately a 70% reduction in post-GLP-1 weight regain.

Speaker #2: Like ablation length, the treatment effect scaled 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.

Speaker #2: At six 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 it will enable efficacy endpoints in our pivotal study later this year.

Harith Rajagopalan: 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's statistical analysis plan and operational progress. Our plan was always to analyze the six-month midpoint cohort to inform our understanding of the key drivers of effect size and then to use this information to pre-specify the pivotal cohort's statistical plan. The pivotal SAP, which we will file with FDA shortly, incorporates these parameters as pre-specified analyses, and this will enable clarity on effect size and durability as a function of treatment dose and patient selection in the pivotal study.

Speaker #2: This is also classic translational pharmacology applied to a procedural therapy: identification of the right patients and the right dose to optimize a clinical profile and achieve a large treatment effect.

Speaker #2: Turning now to the pivotal study's statistical analysis plan and operational progress. Our plan was always to analyze the six-month midpoint cohort to inform our understanding of the key drivers of effect size, and then to use this information to pre-specify the pivotal cohort's statistical plan.

Speaker #2: The pivotal SAP, which we will file with the FDA shortly, incorporates these parameters as pre-specified analyses, and this will enable clarity on effect size and durability as a function of treatment dose and patient selection in the pivotal study.

Speaker #2: I also want to provide clarity about our endpoint structure. REMAIN 1 has two co-primary endpoints. The first is percent body weight regain in the Revita arm versus sham at six months.

Harith Rajagopalan: I also want to provide clarity about our endpoint structure. REMAIN-1 has two co-primary endpoints. The first is percent body weight regain in the Revita arm versus sham at six 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 one 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.

Speaker #2: 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 one year after GLP-1 discontinuation.

Speaker #2: Both co-primaries are required to be met at p < 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.

Speaker #2: 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.

Speaker #2: 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.

Harith Rajagopalan: 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. 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.

Speaker #2: 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, and the blinded adverse event profile remains encouragingly consistent with what we have seen in prior studies.

Speaker #2: And we remain on track to deliver top-line six-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.

Speaker #2: You may remember that we aimed to get that feedback in Q2, but our most recent discussion with the 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.

Harith Rajagopalan: 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 six-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. 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.

Speaker #2: With this positive feedback now in hand, ahead of schedule, we are on track for de novo submission in late Q4 2026 with six-month pivotal data in hand.

Speaker #2: 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, 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.

Speaker #2: 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.

Harith Rajagopalan: 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-1, 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.

Speaker #2: 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-1, and more than half of these are likely to discontinue.

Speaker #2: 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.

Speaker #2: 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.

Harith Rajagopalan: 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've worked 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 one.

Speaker #2: 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.

Speaker #2: 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 worked so hard to achieve.

Speaker #2: 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.

Speaker #2: The payment economics work for hospitals from nearly day one. The transitional path through payment via 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.

Harith Rajagopalan: Transitional pass-through payment via 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 two 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 H2 this year.

Speaker #2: 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.

Speaker #2: 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 Rejuva 001 in type 2 diabetes to regulators in the EU and Australia, and we anticipate regulatory feedback in Q2 2026.

Speaker #2: Expect reporting of 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.

Harith Rajagopalan: 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 Rejuva zero zero one. 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. In late Q4 this year, potential de novo marketing application submission for Revita in post-GLP-1 weight maintenance.

Speaker #2: 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 Rejuva 001.

Speaker #2: In Q3, we will see one-year remain-one 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.

Speaker #2: In early Q4, we will anticipate seeing top-line six-month randomized data from the remaining one pivotal study; this is the single most important catalyst in our company’s history.

Speaker #2: 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 Rejuva 001, subject to CTA authorization, and preliminary safety and PK data.

Harith Rajagopalan: In H2 of this year, we will also see human dosing of Rejuva-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 of weight loss after GLP-1 discontinuation, and it is a catalyst-rich year ahead. Lara?

Speaker #2: Each of these milestones moves us closer to delivering the first potential procedural therapy for maintenance of weight loss after GLP-1 discontinuation, and it is a catalyst-rich year ahead.

Speaker #2: Lara.

Speaker #1: 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.

Lara Smith Weber: Thank you, Harith. Research and development expenses were $16.5 million for the quarter ended 31 December 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 underwriter's 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.

Speaker #1: 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.

Speaker #1: 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 financing.

Speaker #1: We reported a net loss of $43.7 million for Q4 2025 compared to $25.0 million in Q4 2024. However, $20.2 million of the increase was a non-cash accounting change in the fair value of our warrant liabilities, which does not reflect a change in our underlying operating performance.

Lara Smith Weber: However, the $20.2 million of the increase was a non-cash 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 -$21.2 million for Q4 2025, compared to -$22.1 million for Q4 2024, reflecting the decrease in operating expenses. As of 31 December 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.

Speaker #1: 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 2025, compared to negative $22.1 million for Q4 2024, reflecting the decrease in operating expenses.

Speaker #1: As of December 31, 2025, we had approximately $81.5 million in cash and cash equivalents. Based on our current business plan, we believe this cash position, combined with the $4.1 million in subsequent proceeds from warrant exercises received in January 2026, will fund operations into early 2027.

Lara Smith Weber: 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.

Speaker #1: Importantly, this funds the company beyond the anticipated remaining pivotal data readout in early Q4 2026 and through a potential de novo submission in late Q4 2026.

Speaker #1: 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.

Speaker #2: 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.

Harith Rajagopalan: Thank you, Laura. 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 run-in weight loss and longer ablation lengths.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Second, the pivotal is built to win with strong powering on the full cohort and enrichment in an optimized cohort of patients with high run-in weight loss and longer ablation lengths.

Speaker #2: 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.

Harith Rajagopalan: Third, we see a clear path to commercial value with favorable De Novo feedback and a large defined and growing market opportunity. 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #3: Thank you. At this time, we'll conduct the question-and-answer session. As a reminder, to ask a question, you'll need to press *11 on your telephone and wait for your name to be announced.

Operator: Thank you. At this time, we'll conduct a question and answer session. As a reminder, to ask a question, you'll 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 Adam of Canaccord Genuity. Your line is now open.

Speaker #3: To withdraw your question, please press star 11 again. Please stand by while I compile the Q&A roster. In our first question concerning the line of Wendy Isham of Cancor Genuine, your line is now open.

Speaker #4: Hi, guys. Thanks for taking our question. This is Angela on for Whitney. Can you guys just remind us how the ablation length is determined again?

[Analyst] (Canaccord Genuity): Hi, guys. Thanks for taking our question. This is Angela on for Whitney. Can you guys just remind us how the ablation length is determined again? Is it after the patient is already during the procedure, right? Yeah, I guess, like, how is that length determined? Then it sounds like 16cm is the cutoff now. Like, going forward, is that the target minimum ablation length? Thank you.

Angela Qian: Hi, guys. Thanks for taking our question. This is Angela on for Whitney. Can you guys just remind us how the ablation length is determined again? Is it after the patient is already during the procedure, right? Yeah, I guess, like, how is that length determined? Then it sounds like 16cm is the cutoff now. Like, going forward, is that the target minimum ablation length? Thank you.

Speaker #4: Is that it's after the patient has already—during the procedure, right? And so yeah, I guess, how is that length determined? And then it sounds like 16 centimeters is the cutoff now, so going forward, is that the target minimum ablation length?

Speaker #4: Thank you.

Speaker #2: Yeah, 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.

Harith Rajagopalan: Yeah. 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 10cm of ablation had more glucose-lowering efficacy than 3cm. We are seeing the same thing now in obesity, but at higher lengths of ablation. Our ablation balloon is 2cm 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Harith Rajagopalan: What is clear is that the ablation length for weight effects is greater than or equal to 16cm. That will be our operating standard going forward and will be built into the key secondary endpoints in our pivotal study. 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.

Speaker #2: And we'll 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.

Speaker #2: We believe this to be the reason for the 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.

Speaker #4: Great, thank you. Maybe just a quick follow-up. I guess—does this impact how doctors are going to be trained in the future in terms of the length of ablation? And were they conducting less ablation because they were less comfortable with it? If you could just provide more color around that?

[Analyst] (Canaccord Genuity): Great. Thank you. 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, you know, were they conducting less ablation because they were less comfortable with it? Or if you could just provide more color around that.

Angela Qian: Great. Thank you. 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, you know, were they conducting less ablation because they were less comfortable with it? Or if you could just provide more color around that.

Speaker #2: Well, in the pivotal study, we advised patients or doctors to ablate at least 10 centimeters, and from the anatomical landmark at the beginning of the duodenum towards the end of the duodenum.

Harith Rajagopalan: Well, in the pivotal study, we advise patients or doctors to ablate at least 10cm, and from the anatomical landmark at the beginning of the duodenum towards the end of the duodenum. But it was left to the physician's discretion how much ablations to perform. In that study, everyone was trained to be able to successfully perform greater than 14cm of ablation across the board. 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.

Speaker #2: But it was left to the physician's discretion how much ablation to perform. In that study, everyone was trained to be able to successfully perform greater than 14 centimeters of ablation across the board.

Speaker #2: 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.

Speaker #4: Got it. Thanks, very helpful. Thank you.

[Analyst] (Canaccord Genuity): Got it. Thanks. Very helpful. Thank you.

Angela Qian: Got it. Thanks. Very helpful. Thank you.

Speaker #2: Thank you.

Harith Rajagopalan: Thank you.

Speaker #3: Thank you. One moment for our next question. Our next question concerns the line of Michael DiFiore of Evercore SI. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Michael DiFiore of Evercore ISI. Your line is now open.

Speaker #5: Hey, guys. Thanks so much for taking my question. 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.

Michael DiFiore: Hey, guys. Thanks so much for taking my question. 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. I guess my question is, to what extent does efficacy play in the final determination here, or is it all about safety? I have a follow-up.

Speaker #5: 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.

Speaker #2: 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.

Harith Rajagopalan: Well, 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. The efficacy threshold for PMA and De Novo are also 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.

Speaker #2: 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.

Speaker #5: 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.

Michael DiFiore: I see. That's helpful. 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 cm. I guess my question is, in the real world, based on the average patient, is 16 cm readily achievable, or is the average patient's anatomy more conducive to less centimeter ablations?

Speaker #5: 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?

Speaker #2: 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.

Harith Rajagopalan: In the pivotal cohort, mean and median ablation length was greater than 16cm and is readily achievable by all of the investigators that we've trained, and we believe that will be translatable to the broader population.

Speaker #2: And we believe that will be translatable to the broader population.

Speaker #5: Thanks so much.

Michael DiFiore: Thanks so much.

Speaker #2: Yeah.

Harith Rajagopalan: Yeah.

Speaker #3: Thank you. One moment for our next question. Our next question concerns the line of Jason Gerberi of Bakerman Securities. Your line is now open.

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

Speaker #6: Hey, guys. This is Chiang for Jason. Thanks for taking our questions. Maybe a follow-up on the ablation length—can you provide more color on the post-op analysis for the midpoint data set?

Chi Young: Hey, guys. This is Chi Young for Jason. Thanks for taking our questions. Maybe just a follow-up on the ablation lengths. Can you provide more color on the post-op analysis for the midpoint data set? More specifically, can you remind us the ablation lengths and GLP-1 induced weight loss from the midpoint cohort and how that compares to the metrics you provide for the pivotal cohort? Secondarily, how much variability in the ablation length you saw in the midpoint cohort compared to the pivotal cohort? I guess ultimately, how does this post-hoc analysis impact your confidence for the pivotal read out later this year? Thanks so much.

Shane Young: Hey, guys. This is Shane Young for Jason. Thanks for taking our questions. Maybe just a follow-up on the ablation lengths. Can you provide more color on the post-op analysis for the midpoint data set? More specifically, can you remind us the ablation lengths and GLP-1 induced weight loss from the midpoint cohort and how that compares to the metrics you provide for the pivotal cohort? Secondarily, how much variability in the ablation length you saw in the midpoint cohort compared to the pivotal cohort? I guess ultimately, how does this post-hoc analysis impact your confidence for the pivotal read out later this year? Thanks so much.

Speaker #6: More specifically, can you remind us of the ablation length and split-run-induced weight loss from the midpoint cohort? And how does that compare to the metrics you provided for the pivotal cohort?

Speaker #6: 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-op analysis impact your confidence for the pivotal readout later this year?

Speaker #6: Thanks so much.

Speaker #2: Well, this is a post-op analysis in the midpoint cohort. It was already a pre-specified analysis in the pivotal study and is consistent with pre-specified studies we've conducted on dose and type 2 diabetes in the past.

Harith Rajagopalan: Well, this is a post-hoc analysis in the midpoint cohort. It was already a pre-specified analysis in the pivotal study and is consistent with pre-specified studies we've conducted on dose and type 2 diabetes in the past. 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. 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.

Speaker #2: 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 feel confident that we can train physicians to perform longer ablations in the pivotal.

Speaker #2: 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.

Harith Rajagopalan: Number one, we are very well powered at well over 90% for the full cohort, and we have key secondary endpoints that we have pre-specified that will interrogate patients who receive more than 16cm of ablation and in patients who have more run-in weight loss on the GLP-1. 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.

Speaker #2: And we have key secondary endpoints that we have pre-specified that will interrogate patients who receive more than 16 centimeters of ablation and in patients who receive who have more run-in weight loss on the GLP-1.

Speaker #2: And we are confident that each of those independently and collectively will drive larger and compounding treatment effects in the pivotal study. And we'll 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.

Speaker #6: 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.

Chi Young: Got it. The ablation length for the pivotal cohort is what you have observed is longer than the ablation length in the midpoint cohort?

Shane Young: Got it. The ablation length for the pivotal cohort is what you have observed is longer than the ablation length in the midpoint cohort?

Speaker #2: That's right.

Harith Rajagopalan: That's right.

Speaker #6: Okay. And given you have, already, fully randomized the pivotal cohort, 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 have conducted.

Chi Young: Okay. Given you have already fully randomized the pivotal cohort, is it fair to assume that all the ablation had already occurred and you're talking about ablation lengths you have observed for all the procedures that have conducted?

Shane Young: Okay. Given you have already fully randomized the pivotal cohort, is it fair to assume that all the ablation had already occurred and you're talking about ablation lengths you have observed for all the procedures that have conducted?

Speaker #2: Yep, that's locked. And I think it's worth saying that we're more than one month out from the last randomization now, and the safety signal in our blinded analysis continues to be very encouraging.

Harith Rajagopalan: Yep, that's locked. I think it's worth saying that we're more than one month out from the last randomization now, and the safety signal in our blinded analysis continues to be very encouraging. 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.

Speaker #2: 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 increased the probability of success on the efficacy.

Speaker #2: Angle as well.

Speaker #6: Okay. Great. Thanks so much.

Operator: Okay, great. Thanks so much.

Shane Young: Okay, great. Thanks so much.

Speaker #2: Thanks.

Harith Rajagopalan: Thanks.

Speaker #3: Thank you. One moment for our next question. Our next question concerns the line of Mike Ols of Morgan Stanley. Your line is now open.

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

Mike Olfe: Good afternoon. Thanks for taking the question. Maybe just another one related to ablation. Just curious how long it takes to sort of train these physicians, you know, to be able to do the procedure, you know, to ensure adequate ablation. Is that something that's fairly quick? Or how much experience does it take to kinda make sure that they're hitting that mark? Thanks.

Speaker #7: Good afternoon. Thanks for taking the question. 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.

Michael Wolf: Good afternoon. Thanks for taking the question. Maybe just another one related to ablation. Just curious how long it takes to sort of train these physicians, you know, to be able to do the procedure, you know, to ensure adequate ablation. Is that something that's fairly quick? Or how much experience does it take to kinda make sure that they're hitting that mark? Thanks.

Speaker #7: 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? Thanks.

Speaker #2: This training that we've built is works very well. It takes less than three to four cases to train a physician to perform ablations. The shorter lengths of ablations that we sometimes see in the midpoint cohort and the pivotal cohort are often reflective of the first couple of cases that a physician is performing.

Harith Rajagopalan: This training that we've built works very well. It takes less than 3 to 4 cases to train a physician to perform ablations. The shorter lengths of ablations that we sometimes see in the midpoint cohort and the pivotal cohort are often reflective of the first couple of cases that a 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 training regime and the treatment recommendation in commercial use. I think that's gonna help standardize real world outcomes.

Speaker #2: 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.

Speaker #2: In commercial use, and I think that's going to help standardize real-world outcomes.

Mike Olfe: Yeah, very helpful. Thank you.

Michael Wolf: Yeah, very helpful. Thank you.

Speaker #7: Very helpful. Thank you.

Speaker #2: Thank you.

Harith Rajagopalan: Thank you.

Speaker #3: Thank you. One moment for our next question. Our next question concerns the line of Jeffrey Cohen of Lindenburg Dominant Company. Your line is now open.

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

Jeffrey Cohen: Hello, Harith and Lara. Sorry to be redundant. On the, in 2023, 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?

Jeffrey Scott Cohen: Hello, Harith and Lara. Sorry to be redundant. On the, in 2023, 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?

Speaker #8: Hello. Harith and Laura. So I'm sorry to be redundant. So on the in Q3, when we see the one-year remain midpoint cohort, will we see further analysis by length as far as the data that you're reading out?

Speaker #2: Yes.

Harith Rajagopalan: Yes.

Speaker #8: 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?

Jeffrey Cohen: Got it. 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?

Jeffrey Scott Cohen: Got it. 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?

Speaker #2: 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.

Harith Rajagopalan: No, nothing has changed. 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, 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.

Speaker #2: 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.

Speaker #2: And that is very useful information. We're glad to have it.

Speaker #8: That's helpful. And then could you talk about the CPT code? So as I understand it, if you file during a midpoint somewhere in 2027, at that could or would take effect January 1st, 28th.

Jeffrey Cohen: That's helpful. Then could you talk about the CPT code? So as I understand it, if you file during a midpoint somewhere in 2027, that could or would take effect January 1, 2028. Are you also suggesting that it's possible that you'll have a T code that would take effect sometime in 2027?

Jeffrey Scott Cohen: That's helpful. Then could you talk about the CPT code? So as I understand it, if you file during a midpoint somewhere in 2027, that could or would take effect January 1, 2028. Are you also suggesting that it's possible that you'll have a T code that would take effect sometime in 2027?

Speaker #8: Are you also suggesting that it's possible that you'll have a T code that would take effect sometime in 2027?

Speaker #2: We're anticipating filing for category 3 CPT code in June of this year. It's reviewed in September and should go into effect in the summer of 2027, July 1st.

Harith Rajagopalan: We're anticipating filing for the Category III CPT code in June of this year. It gets reviewed in September and should go into effect in the summer of 2027, 1 July. We are also intending to file for a transitional pass-through payment through CMS immediately upon FDA authorization. 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #8: Okay. And I'm assuming you're also take on pair discussion late this year commencing late this year as far as pair discussion?

Jeffrey Cohen: Okay. I'm assuming you'll also take on payer discussion late this year, commencing late this year as far as payer discussion?

Jeffrey Scott Cohen: Okay. I'm assuming you'll also take on payer discussion late this year, commencing late this year as far as payer discussion?

Speaker #2: That's right. I mean, 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.

Harith Rajagopalan: That's right. I mean, 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 de-risked clinical package that we could then use to inform our payer discussions and drive towards our regulatory submission calendar.

Speaker #2: That's a fully de-risked clinical package that we could then use to inform our payer discussions. And drive towards our regulatory submission calendar.

Speaker #8: Perfect. Thanks for taking the questions.

Jeffrey Cohen: Perfect. Thanks for taking the questions.

Jeffrey Scott Cohen: Perfect. Thanks for taking the questions.

Speaker #2: Thank you, Jeff.

Harith Rajagopalan: Thank you, Jeff.

Speaker #3: Thank you. One moment for our next question. Our next question concerns the line of Joe Panjajanis of AC WinRight. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Joseph Pantgiotis of H.C. Wainwright. Your line is now open.

Joseph Pantgiotis: Hey. Hey, everybody. Thanks for taking the questions. My first question is shorter, but maybe a more complex answer. First, with the De Novo filing, positive feedback, how would we view the totality of regulatory submissions over the next year or so, you know, with regard to, is it a multi-step process, or is it similar to a rolling BLA, or how should we view it?

Joe Pantiginis: Hey. Hey, everybody. Thanks for taking the questions. My first question is shorter, but maybe a more complex answer. First, with the De Novo filing, positive feedback, how would we view the totality of regulatory submissions over the next year or so, you know, with regard to, is it a multi-step process, or is it similar to a rolling BLA, or how should we view it?

Speaker #9: everybody. Thanks for taking the questions. 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 same year over the next year or so?

Speaker #9: With regard to, is it a multi-step process? Or is it similar to a rolling BLA? Or how should we view it?

Harith Rajagopalan: There are three main packages to the regulatory submission. There is a design history file, which is the device design. There is 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. We will also be ready to submit 12-month data in Q1 2027, should that be necessary.

Speaker #2: There are three main packages to the regulatory submission. There is a design history file, which is the device design. There is a manufacturing file, which reflects how we manufacture our systems.

Speaker #2: And then there will be clinical data. We will have a full package of six-month data by the end of this year. There is we will also be ready to submit 12-month data in the first quarter of 2027 should that be necessary.

Speaker #9: That's great. Thank you for that. 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.

Joseph Pantgiotis: That's great. Thank you for that. If I heard you correctly, correct me if I'm wrong, it sounded like you're gonna be filing the SAP relatively soon. With regard to the ablation lengths that we've been discussing today, and it's very intriguing data, by the way, you know, how would you look at, and you mentioned it's a pre-specified population, how would that factor into the statistical analysis plan and also the role of the secondary endpoints that you mentioned and, you know, the hierarchy of them?

Joe Pantiginis: That's great. Thank you for that. If I heard you correctly, correct me if I'm wrong, it sounded like you're gonna be filing the SAP relatively soon. With regard to the ablation lengths that we've been discussing today, and it's very intriguing data, by the way, you know, how would you look at, and you mentioned it's a pre-specified population, how would that factor into the statistical analysis plan and also the role of the secondary endpoints that you mentioned and, you know, the hierarchy of them?

Speaker #9: So, with regard to the ablation length that we've been— the way— How would you look at— and you mentioned it's a pre-specified population. How would that factor into the statistical analysis plan, and also the role of the secondary endpoints— that— of them?

Speaker #2: 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.

Harith Rajagopalan: Great question. Obviously, details on the hierarchy are gonna be pending our conversation with the FDA. We'll share that with you when we have it. I would make two 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 16cm, which is where Revita's efficacy is very clear based on the midpoint cohort. The mean run-in weight loss was over 18% total body weight, which is where Revita's efficacy is also very clear. This, the right down the middle of the fairway of our pivotal enrollment is exactly the sweet spot of where we are seeing efficacy. We're confident in that, and we have designed key secondary endpoints in order to be able to demonstrate that very clearly.

Speaker #2: I would make two points right now. Number one, the sweet spot of the enrollment and randomization of the pivotal study are exactly the patients in whom Rubida appears to be working best.

Speaker #2: The mean ablation length was more than 16 centimeters. Which is where Rubida's efficacy is very clear. Based on the midpoint cohort. And the mean run-in weight loss was over 18% total body weight.

Speaker #2: Which is where Rubida'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.

Speaker #2: And so we're confident in that, and we have designed key secondary endpoints in order to be able to demonstrate that very clearly.

Speaker #9: Got it. Thanks for the feedback.

Joseph Pantgiotis: Got it. Thanks for the feedback.

Joe Pantiginis: Got it. Thanks for the feedback.

Speaker #2: Thank you.

Harith Rajagopalan: Thank you.

Speaker #3: Thank you. On I turn the call back to Dr. Rajagopalan for closing remarks.

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

Speaker #2: 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.

Harith Rajagopalan: 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.

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

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