Q2 2026 Fractyl Health Inc Earnings Call

August 10, 2026

Speaker #1: Good afternoon, and welcome to Fractyl Health's second quarter 2026 financial results and business update call. As a reminder, this conference call is being recorded.

Operator: Good afternoon, and welcome to Fractyl Health's Q2 2026 financial results and business update call. As a reminder, this conference call is being recorded. At this time, all participants are on listen-only mode. There will be a Q&A session following management's prepared remarks. I will now turn the call over to Brian Luque, Head of Investor Relations and Corporate Development at Fractyl. Brian, you may now begin.

Operator: Good afternoon, and welcome to Fractyl Health's Q2 2026 Financial Results and Business Update Call. As a reminder, this conference call is being recorded. At this time, all participants are on listen-only mode. There will be a Q&A session following management's prepared remarks. I will now turn the call over to Brian Luque, Head of Investor Relations and Corporate Development at Fractyl. Brian, you may now begin.

Speaker #1: At this time, all participants are in listen-only mode. There will be a Q&A session following management's prepared remarks. I will now turn the call over to Brian Luque, Head of Investor Relations and Corporate Development at FRACTYL.

Speaker #1: Brian, you may now begin.

Speaker #2: 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.

Brian LaGrave: Thank you. This afternoon, we issued a press release that outlines the topics we plan to discuss today. This release is available at www.fractyl.com under the Investors tab. Joining us on the call today are Dr. Harith Rajagopalan, Chief Executive Officer, and Lara Smith Weber, Chief Financial Officer. During this call, we make forward-looking statements which involve risks and uncertainties that may cause 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.

Brian Luque: Thank you. This afternoon, we issued a press release that outlines the topics we plan to discuss today. This release is available at www.fractyl.com under the Investors tab. Joining us on the call today are Dr. Harith Rajagopalan, Chief Executive Officer, and Lara Smith Weber, Chief Financial Officer.

Speaker #2: Joining us on the call today are Dr. Harith Rajagopalan, Chief Executive Officer, and Laura Smith-Weber, Chief Financial Officer. During this call, we may make forward-looking statements, which involve risks and uncertainties and may cause actual results to differ materially from our forward-looking statements.

Brian Luque: 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.

Speaker #2: 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.

Speaker #2: 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.

Brian Luque: 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 #2: It is now my pleasure to pass the call over to Harith.

Brian LaGrave: It is now my pleasure to pass the call over to Harith.

Speaker #3: Thank you, Brian. Good afternoon, everyone. Nearly 30 million Americans are now on GLP-1 therapy; approximately 1 million are discontinuing each month. What happens after discontinuation is now well characterized.

Harith Rajagopalan: Thank you, Brian. Good afternoon, everyone. Nearly 30 million Americans are now on GLP-1 therapy. Approximately 1 million are discontinuing each month. What happens after discontinuation is now well-characterized. On average, patients regain roughly 60% of their prior weight loss within 12 months of stopping therapy, and cardiometabolic benefits begin to erode even earlier. For many patients, the choice is either to resume chronic pharmacotherapy or accept substantial weight regain. We believe Revita has the potential to offer a third option, durable drug-free weight maintenance following a one-time endoscopic procedure. A year ago, that was our thesis. Now we have the first randomized sham-controlled evidence supporting that thesis one year after GLP-1 discontinuation and the most direct read-through to the REMAIN-1 pivotal cohort expected in early Q4. On our last three calls, I laid out four pillars that give us conviction in Revita. First, the clinical signal is real.

Speaker #3: On average, patients regain roughly 60% of their prior weight loss within 12 months of stopping therapy, and cardiometabolic benefits begin to erode even earlier.

Speaker #3: For many patients, the choice is either to resume chronic pharmacotherapy or accept substantial weight regain. We believe Revita has the potential to offer a third option: durable, drug-free weight maintenance following a one-time endoscopic procedure.

Harith Rajagopalan: We believe Revita has the potential to offer a third option, durable drug-free weight maintenance following a one-time endoscopic procedure. A year ago, that was our thesis. Now we have the first randomized sham-controlled evidence supporting that thesis one year after GLP-1 discontinuation and the most direct read-through to the REMAIN-1 pivotal cohort expected in early Q4. On our last three calls, I laid out four pillars that give us conviction in Revita.

Speaker #3: A year ago, that was our thesis. Now, we have the first randomized, sham-controlled evidence supporting that thesis one year after GLP-1 discontinuation, and the most direct read-through to the remaining one pivotal cohort, expected in early Q4.

Speaker #3: On our last three calls, I laid out four pillars that give us conviction in Revita: First, the clinical signal is real; second, our pivotal study is built to win; third, there is a clear path to commercial value; and fourth, we are funded through definitive data later this year.

Harith Rajagopalan: First, the clinical signal is real. Second, our pivotal study is built to win. Third, there is a clear path to commercial value. Fourth, we are funded through definitive data later this year. Let me take each of them in turn, but I will spend most of my time on the commercial opportunity today.

Harith Rajagopalan: Second, our pivotal study is built to win. Third, there is a clear path to commercial value. Fourth, we are funded through definitive data later this year. Let me take each of them in turn, but I will spend most of my time on the commercial opportunity today. Pillar 1, the clinical signal is real. On 15 July, we reported 1-year randomized data from the REMAIN-1 midpoint cohort. The study asked a simple question. 1 year after stopping a GLP-1 therapy, how much of the weight loss do patients keep? Revita patients maintain more than 80% of their prior GLP-1 induced weight loss at 1 year, compared with 46% in the sham arm. The treatment effect held from month 6 through month 12 under maintained blinding in a cohort where not one patient reinitiated GLP-1 therapy.

Speaker #3: Let me take each of them in turn, but I'll spend most of my time on the commercial opportunity today. Pillar one: the clinical signal is real.

Harith Rajagopalan: Pillar 1, the clinical signal is real. On 15 July, we reported 1-year randomized data from the REMAIN-1 midpoint cohort. The study asked a simple question. 1 year after stopping a GLP-1 therapy, how much of the weight loss do patients keep? Revita patients maintain more than 80% of their prior GLP-1 induced weight loss at 1 year, compared with 46% in the sham arm. The treatment effect held from month 6 through month 12 under maintained blinding in a cohort where not one patient reinitiated GLP-1 therapy.

Speaker #3: On July 15, we reported one-year randomized data from the RemainD-1 midpoint cohort. The study asked a simple question: One year after stopping a GLP-1 therapy, how much of the weight loss do patients keep?

Speaker #3: Revita patients maintain more than 80% of their prior GLP-1–induced weight loss at one year, compared with 46% in the sham arm. The treatment effect held from month 6 through month 12 under maintained blinding in a cohort where not one patient reinitiated GLP-1 therapy.

Speaker #3: And an additional piece of confirmatory evidence: the open-label Reveal-1 cohort showed a consistent signal in June, with participants maintaining approximately 78% of their prior weight loss through one year after a single procedure.

Harith Rajagopalan: An additional piece of confirmatory evidence, the open label REVEAL-1 cohort showed a consistent signal in June, with participants maintaining approximately 78% of their prior weight loss through 1 year after a single procedure. We now have two different patient populations showing 1 year of durable weight maintenance and compelling effect size after Revita. This directly addresses the most important question about our 6-month data presented earlier in the year. Were we producing durable separation or simply delaying weight regain? Dr. Adarsh Thakur of UCLA, a principal investigator on REMAIN-1, named that concern on our July call and told us that the curves are now showing hints of a plateau at the 1-year mark. Two details sit behind those numbers.

Speaker #3: So, we now have two different patient populations showing one year of durable weight maintenance and a compelling effect size after Revita. This directly addresses the most important question about our six-month data presented earlier in the year—were we producing durable separation, or simply delaying weight regain?

Harith Rajagopalan: This directly addresses the most important question about our 6-month data presented earlier in the year. Were we producing durable separation or simply delaying weight regain? Dr. Adarsh Thakur of UCLA, a principal investigator on REMAIN-1, named that concern on our July call and told us that the curves are now showing hints of a plateau at the 1-year mark. Two details sit behind those numbers.

Speaker #3: Dr. Adar Schlacker of UCLA, a principal investigator on Remain One, named that concern on our July call and told us that the curves are now showing hints of a plateau at the one-year mark.

Speaker #3: Two details sit behind those numbers: the strongest results came in patients who achieved complete ablations and higher run-in weight loss; the two variables, the pivotal studies enriched for.

Harith Rajagopalan: The strongest results came in patients who achieved complete ablations and higher run-in weight loss, the two variables the pivotal study is enriched for. The sham arm behaved as published literature would expect and predict, providing strong external validity to the study outcomes. I would like to spend a minute on safety and tolerability because I believe it is one of the largest single drivers of Revita's eventual adoption. Through 1 full year, there were zero device or procedure-related serious adverse events. In fact, in the midpoint cohort, there were only four mild treatment emergent adverse events in the entire study, all resolved within 2 days. For a procedural therapy in obesity, this is an unusually clean profile, and it is the reason we believe adoption by physicians and patients may be substantial. Compare this profile with the only alternative these patients have today.

Speaker #3: And the sham arm behaved as published literature would expect and predict, providing strong external validity to the study outcomes. I'd like to spend a minute on safety and tolerability because I believe it is one of the largest single drivers of Revita's eventual adoption.

Speaker #3: Through one full year, there were zero device- or procedure-related serious adverse events. In fact, in the midpoint cohort, there were only four mild treatment-emergent adverse events in the entire study, all of which resolved within two days.

Harith Rajagopalan: Through 1 full year, there were zero device or procedure-related serious adverse events. In fact, in the midpoint cohort, there were only four mild treatment emergent adverse events in the entire study, all resolved within 2 days. For a procedural therapy in obesity, this is an unusually clean profile, and it is the reason we believe adoption by physicians and patients may be substantial. Compare this profile with the only alternative these patients have today.

Speaker #3: For a procedural therapy in obesity, this is an unusually clean profile, and it is the reason we believe adoption by physicians and patients may be substantial.

Speaker #3: Compare this profile with the only alternative these patients have today, GLP-1 medicines or associated with high rates of GI adverse events, the more potent the agent, the more adverse events.

Harith Rajagopalan: GLP-1 medicines are associated with high rates of GI adverse events. The more potent the agent, the more adverse events. Primary care providers are already referring patients to gastroenterologists to help manage these GI side effects. That potential to address a real concern for patients is why a gastroenterologist is prepared to offer this procedure to the patient who walks into clinic or the endoscopy suite, and why a patient who cannot or will not stay on a GLP-1 is willing to try it. Pillar 2, the pivotal is built to win. The REMAIN-1 pivotal cohort is a larger, well-powered version of the midpoint cohort, just run larger. Same patient profile, same protocol, same investigators, same blinded dietician oversight. It is the largest sham-controlled GI endoscopy pivotal trial for a novel therapeutic device ever conducted.

Speaker #3: Primary care providers are already referring patients to gastroenterologists to help manage these GI side effects. That potential to address a real concern for patients is why a gastroenterologist is prepared to offer this procedure to the patient who walks into clinic or the endoscopy suite, and why a patient who cannot or will not stay on a GLP-1 is willing to try it.

Speaker #3: Pillar two: The pivotal is built to win. The remaining one pivotal cohort is a larger, well-powered version of the midpoint cohort, just run larger.

Harith Rajagopalan: Pillar 2, the pivotal is built to win. The REMAIN-1 pivotal cohort is a larger, well-powered version of the midpoint cohort, just run larger. Same patient profile, same protocol, same investigators, same blinded dietician oversight. It is the largest sham-controlled GI endoscopy pivotal trial for a novel therapeutic device ever conducted.

Speaker #3: Same patient profile, same protocol, same investigators, same blinded dietitian oversight. It is the largest sham-controlled GI endoscopy pivotal trial for a novel therapeutic device ever conducted.

Speaker #3: We completed randomization in February, with more than 300 participants across more than 30 sites and more than 20 operators. Importantly, the pivotal is enriched for the two variables that were associated with greater treatment effect: the threshold for a complete ablation is 14 centimeters, and in the pivotal, the median ablation length is 16 centimeters, and the mean is closer to 17.

Harith Rajagopalan: We completed randomization in February with more than 300 participants across more than 30 sites with more than 20 operators. Importantly, the pivotal is enriched for the two variables that were associated with greater treatment effect. The threshold for a complete ablation is 14 centimeters. In the pivotal, the median ablation length is 16 centimeters, and the mean is closer to 17. The threshold for higher run-in weight loss is approximately 17.5%. In the pivotal, the mean run-in weight loss is 18.3%. We have two co-primary endpoints, and based on the data we have generated to date, we estimate both are well powered above 95%. The first is percent total body weight regain between Revita and sham at 6 months.

Harith Rajagopalan: In the pivotal, the median ablation length is 16 centimeters, and the mean is closer to 17. The threshold for higher run-in weight loss is approximately 17.5%. In the pivotal, the mean run-in weight loss is 18.3%. We have two co-primary endpoints, and based on the data we have generated to date, we estimate both are well powered above 95%. The first is percent total body weight regain between Revita and sham at 6 months.

Speaker #3: The threshold for higher run-in weight loss is approximately 17.5%, and the pivotal mean run-in weight loss is 18.3%. We have two co-primary endpoints, and based on the data we've generated to date, we estimate both are well-powered above 95%.

Speaker #3: The first is percent total body weight regain between Revita and sham at six months. The required margin is a separation of roughly 2.5 percentage points, and the midpoint MITT result, using the pre-specified statistical analysis plan submitted to the FDA, clears that comfortably.

Harith Rajagopalan: The required margin is a separation of roughly 2.5 percentage points, and the midpoint MITT result using the pre-specified statistical analysis plan submitted to the FDA clears that comfortably. The second is the responder rate. The FDA-mandated pre-specified performance goal is a single-arm result of at least 50% of patients maintaining at least 5% total body weight loss at 12 months. In the midpoint cohort, that figure was 73% in the MITT population and above 90% in the complete ablation population. Every operational metric that we believe is important to the pivotal success continues to track favorably. Retention remains well above 90%. Medication resumption remains below our modeled assumptions. The blinded adverse event profile remains consistent with what we have seen across prior studies, reinforced by our DSMB interactions.

Speaker #3: The second is the responder rate. The FDA mandated pre-specified performance goal is a single-arm result of at least 50% of patients maintaining at least 5% total body weight loss at 12 months.

Speaker #3: In the midpoint cohort, that figure was 73% in the MITT population, and above 90% in the complete ablation population. Every operational metric that we believe is important to the pivotal success continues to track favorably.

Harith Rajagopalan: In the midpoint cohort, that figure was 73% in the MITT population and above 90% in the complete ablation population. Every operational metric that we believe is important to the pivotal success continues to track favorably. Retention remains well above 90%. Medication resumption remains below our modeled assumptions. The blinded adverse event profile remains consistent with what we have seen across prior studies, reinforced by our DSMB interactions.

Speaker #3: Retention remains well above 90%. Medication resumption remains below our modeled assumptions. The blinded adverse event profile remains consistent with what we have seen across prior studies, reinforced by our DSMB interactions.

Speaker #3: We remain on track to report top-line six-month primary endpoint data in early Q4 2026, and expect to report top-line 12-month data from the remaining one pivotal cohort in Q1 2027.

Harith Rajagopalan: We remain on track to report top-line 6-month primary endpoint data in early Q4 2026 and expect to report top-line 12-month data from the REMAIN-1 pivotal cohort in Q1 2027. On the regulatory front, we have favorable FDA feedback in hand that Revita's safety profile is consistent with a moderate risk rather than a high-risk device classification. We remain on track for a potential De Novo submission in late Q4 2026 following the 6-month pivotal data readout. As with all applications, final pathway determination will follow FDA's review of the complete safety data set, which we intend to include in the submission. Pillar three, the path to commercial value. One overarching point, the trends that are shaping the GLP-1 market strengthen Revita's commercial opportunity. They expand the addressable market, they increase the potential treatment effect, or they improve the economics, and often all three at once.

Speaker #3: On the regulatory front, we have favorable FDA feedback in hand that Revita's safety profile is consistent with a moderate risk, rather than a high-risk device classification. We remain on track for a potential de novo submission in late Q4 2026, following the six-month pivotal data readout. As with all applications, final pathway determination will follow FDA's review of the complete safety dataset, which we intend to include in the submission.

Harith Rajagopalan: As with all applications, final pathway determination will follow FDA's review of the complete safety data set, which we intend to include in the submission. Pillar three, the path to commercial value. One overarching point, the trends that are shaping the GLP-1 market strengthen Revita's commercial opportunity. They expand the addressable market, they increase the potential treatment effect, or they improve the economics, and often all three at once.

Speaker #3: Pillar three: the path to commercial value. One overarching point: the trends that are shaping the GLP-1 market strengthen Revita's commercial opportunity. They expand the addressable market, they increase the potential treatment effect, or they improve the economics, and often all three at once.

Speaker #3: We will take you through the details at our Investor Day in September. First, the market opportunity is well understood by all key stakeholders. The FDA has granted Revita Breakthrough Device Designation for post-GLP-1 weight maintenance.

Harith Rajagopalan: We will take you through the detail at our investor day in September. First, the market opportunity is well understood by all key stakeholders. FDA has granted Revita breakthrough device designation for post GLP-1 weight maintenance. CMS has begun covering GLP-1s for weight loss while openly raising concerns about frailty and about the affordability of a therapy taken for life. Physicians are already fielding the question. Patients are asking obesity medicine specialists how long they need to stay on the medicine at the moment they are provided the first prescription, and gastroenterologists are now taking referrals for GLP-1 side effects with no off-ramp to offer as of yet. Here is the part I think is most underappreciated. It does not need a new site of care either.

Speaker #3: CMS has begun covering GLP-1s for weight loss, while openly raising concerns about frailty and about the affordability of a therapy taken for life. Physicians are already fielding the question: patients are asking obesity medicine specialists how long they need to stay on the medicine at the moment they are provided the first prescription, and gastroenterologists are now taking referrals for GLP-1 side effects with no off-ramp to offer as of yet.

Harith Rajagopalan: Physicians are already fielding the question. Patients are asking obesity medicine specialists how long they need to stay on the medicine at the moment they are provided the first prescription, and gastroenterologists are now taking referrals for GLP-1 side effects with no off-ramp to offer as of yet. Here is the part I think is most underappreciated. It does not need a new site of care either.

Speaker #3: And here is the part I think is most underappreciated: it does not need a new site of care either. These patients are already in GI clinics and GI labs every day, and the endoscopy suites, physician expertise, and clinical workflows are already in place.

Harith Rajagopalan: These patients are already in GI clinics and GI labs every day, and the endoscopy suites, physician expertise, and clinical workflows are already in place. Second, we view the oral era as a demand engine. One question we often hear is whether more convenient GLP-1 therapies reduce the need for Revita. The evidence to date suggests the opposite. Most oral GLP-1 initiations are new prescriptions rather than switches, and there is no evidence that oral formulations lower the barrier to stopping. Every initiation, oral or injectable, is a potential future discontinuation and need for an off-ramp. Third, the next generation of these medicines may increase rather than diminish Revita's treatment effect. As next-generation therapies deliver even more weight loss, the need for a durable off-ramp only grows. In the REMAIN program, the placebo-adjusted Revita treatment effect in the midpoint cohort increased with greater run-in weight loss.

Speaker #3: Second, we view the oral era as a demand engine. One question we often hear is whether more convenient GLP-1 therapies reduce the need for Revita.

Speaker #3: The evidence to date suggests the opposite: most oral GLP-1 initiations are new prescriptions rather than switches, and there is no evidence that oral formulations lower the barrier to stopping.

Speaker #3: Every initiation, oral or injectable, is a potential future discontinuation and need for an off-ramp. Third, the next generation of these medicines may increase, rather than diminish, Revita's treatment effect.

Harith Rajagopalan: Every initiation, oral or injectable, is a potential future discontinuation and need for an off-ramp. Third, the next generation of these medicines may increase rather than diminish Revita's treatment effect. As next-generation therapies deliver even more weight loss, the need for a durable off-ramp only grows. In the REMAIN program, the placebo-adjusted Revita treatment effect in the midpoint cohort increased with greater run-in weight loss.

Speaker #3: As next-generation therapies deliver even more weight loss, the need for a durable off-ramp only grows. In the REMAINED program, the placebo-adjusted Revita treatment effect in the midpoint cohort increased with greater run-in weight loss.

Speaker #3: The more weight a patient lost on drug, the greater the weight regained after discontinuation, and the larger the measured Revita benefit. Fourth, payers are converging on the need for a durable solution.

Harith Rajagopalan: The more weight a patient lost on drug, the greater the weight regain after discontinuation, and the larger the measured Revita benefit. Fourth, payers are converging on the need for a durable solution. A major development this year was the introduction of the Medicare GLP-1 bridge demonstration, having gone live on 1 July in a population that has both the highest obesity prevalence and high discontinuation risk. CMS administrators expect single-digit million number of patients under Medicare to be on GLP-1s within the next year. The bridge program sunsets at the end of 2027, and the major payer objection is not that obesity treatment does not work. Their concern is the affordability of treatment that continues indefinitely, together with poor adherence and high discontinuation in real-world practice. That is exactly the challenge Revita is designed to address. Pillar four, we are funded through definitive data.

Speaker #3: A major development this year was the introduction of the Medicare GLP-1 bridge demonstration, having gone live on July 1st in a population that has both the highest obesity prevalence and high discontinuation risk.

Speaker #3: CMS administrators expect single-digit million number of patients under Medicare to be on GLP-1s within the next year. The bridge program sunsets at the end of 2027, and the major payer objection is not that obesity treatment does not work; their concern is the affordability of treatment that continues indefinitely together with poor adherence and high discontinuation in real-world practice.

Harith Rajagopalan: CMS administrators expect single-digit million number of patients under Medicare to be on GLP-1s within the next year. The bridge program sunsets at the end of 2027, and the major payer objection is not that obesity treatment does not work. Their concern is the affordability of treatment that continues indefinitely, together with poor adherence and high discontinuation in real-world practice. That is exactly the challenge Revita is designed to address. Pillar four, we are funded through definitive data.

Speaker #3: That is exactly the challenge Revita is designed to address. Pillar four: we are funded through definitive data. Fourth and finally is our capital situation.

Harith Rajagopalan: Fourth, and finally, is our capital situation. Lara will take you through the quarter in detail, but let me state our posture plainly. We ended the quarter with $47.1 million in cash. Our runway extends into early 2027, beyond the pivotal data readout and through a potential De Novo submission. Our ATM facility remains closed. We do not plan to raise capital before we have pivotal data in hand. The marked reduction in cash outlay in Q2 versus Q1 or versus last year, reflects the completion of pivotal randomization and sustained fiscal discipline across the organization. This is a deliberate choice grounded in conviction. We believe the pivotal data will be positive, and we are choosing to operate inside our existing capital envelope through the most consequential two quarters in this company's history as a signal of management alignment with shareholders.

Speaker #3: Laura will take you through the quarter in detail, but let me state our posture plainly. We ended the quarter with 47.1 million dollars in cash.

Speaker #3: Our runway extends into early 2027. Beyond the pivotal data readout, and through a potential de novo submission. Our ATM facility remains closed. We do not plan to raise capital before we have pivotal data in hand.

Speaker #3: The marked reduction in cash outlay in the second quarter versus the first or versus next year versus last year reflects the completion of pivotal randomization and sustained fiscal discipline across the organization.

Harith Rajagopalan: The marked reduction in cash outlay in Q2 versus Q1 or versus last year, reflects the completion of pivotal randomization and sustained fiscal discipline across the organization. This is a deliberate choice grounded in conviction. We believe the pivotal data will be positive, and we are choosing to operate inside our existing capital envelope through the most consequential two quarters in this company's history as a signal of management alignment with shareholders.

Speaker #3: This is a deliberate choice, grounded in conviction. We believe the pivotal data will be positive, and we are choosing to operate inside our existing capital envelope through the most consequential two quarters in this company's history, as a signal of management alignment with shareholders.

Speaker #3: Turning briefly to Rejuva, our smart GLP-1 gene therapy platform targeting long-term metabolic remission from a single dose. In Q2, we received clinical trial authorization in the Netherlands to initiate the phase one slash two first in human study of Rejuva 001.

Harith Rajagopalan: Turning briefly to Rejuva, our smart GLP-1 gene therapy platform targeting long-term metabolic remission from a single dose. In Q2, we received clinical trial authorization in the Netherlands to initiate the phase I/II first-in-human study of RJVA-001. We have also now received ethics committee approval in Australia. We believe RJVA-001 is the first AAV-based gene therapy candidate to enter clinical development for Type 2 diabetes. 001 is a one-time beta cell-targeted gene therapy designed to enable nutrient-responsive, physiologic GLP-1 expression within the pancreas, delivered by a minimally invasive endoscopic ultrasound-guided infusion. The design intent is to avoid the high circulating drug levels that drive the side effects associated with systemic GLP-1 therapy. The primary objective of the first-in-human study is to evaluate the safety and tolerability of 001, together with the feasibility and safety of delivery to the pancreas using the Rejuva system.

Speaker #3: We have also now received ethics committee approval in Australia. We believe Rejuva 001 is the first AAV-based gene therapy candidate to enter clinical development for type 2 diabetes.

Speaker #3: 001 is a one-time, beta cell-targeted gene therapy designed to enable nutrient-responsive, physiologic GLP-1 expression within the pancreas, delivered by a minimally invasive, endoscopic ultrasound-guided infusion.

Harith Rajagopalan: 001 is a one-time beta cell-targeted gene therapy designed to enable nutrient-responsive, physiologic GLP-1 expression within the pancreas, delivered by a minimally invasive endoscopic ultrasound-guided infusion. The design intent is to avoid the high circulating drug levels that drive the side effects associated with systemic GLP-1 therapy. The primary objective of the first-in-human study is to evaluate the safety and tolerability of 001, together with the feasibility and safety of delivery to the pancreas using the Rejuva system.

Speaker #3: The design intent is to avoid the high circulating drug levels that drive the side effects associated with systemic GLP-1 therapy. The primary objective of the first-in-human study is to evaluate the safety and tolerability of 001, together with the feasibility and safety of delivery to the pancreas using the Rejuva system.

Speaker #3: Secondary objectives include assessment of glycemic effect using continuous glucose monitoring and mixed meal tolerance testing. Characterization of GLP-1 secretion and evaluation of immune response.

Harith Rajagopalan: Secondary objectives include assessment of glycemic effect using continuous glucose monitoring and mixed meal tolerance testing, characterization of GLP-1 secretion, and evaluation of immune response. The study uses staggered sentinel dosing, in which the first participant is monitored for a minimum of 14 days and their safety data reviewed before any additional participants in that cohort are dosed. We expect to dose the first patient subject to imminent site of activation and patient enrollment, and to report preliminary data in the H2 of this year. Importantly, Rejuva's clinical development is funded within our existing runway and does not compete with Revita for capital. Before I hand to Lara, here is our near-term calendar.

Speaker #3: The study uses staggered sentinel dosing, in which the first participant is monitored for a minimum of 14 days and their safety data are reviewed before any additional participants in that cohort are dosed.

Speaker #3: We expect to dose the first patient, subject to imminent site activation and patient enrollment, and to report preliminary data in the second half of this year.

Harith Rajagopalan: We expect to dose the first patient subject to imminent site of activation and patient enrollment, and to report preliminary data in the H2 of this year. Importantly, Rejuva's clinical development is funded within our existing runway and does not compete with Revita for capital. Before I hand to Lara, here is our near-term calendar.

Speaker #3: Importantly, Rejuva's clinical development is funded within our existing runway and does not compete with Revita for capital. Before I hand it to Laura, here is our near-term calendar.

Speaker #3: In early September, we will host an investor day to walk through the commercial opportunity, our market access strategy, and the health economics work that our new Senior Vice President of Market Access and Commercial Strategy, Mike Zumdahl, and his team have been leading.

Harith Rajagopalan: In early September, we will host an investor day to walk through the commercial opportunity, our market access strategy, and the health economics work our new Senior Vice President of Market Access and Commercial Strategy, Mike Zumdahl, and his team have been leading. In early Q4, we anticipate reporting top-line 6-month randomized data from the REMAIN-1 pivotal cohort. In late Q4, we anticipate our potential FDA De Novo marketing application submission. In Q1 next year, we anticipate reporting top-line 12-month data from the REMAIN-1 pivotal cohort. Lara?

Speaker #3: In early Q4, we anticipate reporting top-line six-month randomized data from the remaining one pivotal cohort. In late Q4, we anticipate our potential FDA de novo marketing application submission.

Harith Rajagopalan: In early Q4, we anticipate reporting top-line 6-month randomized data from the REMAIN-1 pivotal cohort. In late Q4, we anticipate our potential FDA De Novo marketing application submission. In Q1 next year, we anticipate reporting top-line 12-month data from the REMAIN-1 pivotal cohort. Lara?

Speaker #3: And in Q1 next year, we anticipate reporting top-line 12-month data from the remained one pivotal cohort. Laura?

Speaker #1: Thank you, Harith. Research and development expenses were 13.8 million for the second quarter of 2026, compared with 21.2 million for the same period in 2025.

Lara Smith Weber: Thank you, Harith. Research and development expenses were $13.8 million for the Q2 of 2026, compared with $21.2 million for the same period in 2025. The decrease of $7.3 million was primarily related to reduced spending on our Revita and Rejuva programs. SG&A expenses were $5.3 million for the quarter, compared with $4.9 million for the same period in 2025. The increase of $0.4 million was primarily driven by higher stock compensation expense. We reported a net loss of $25.5 million for the Q2 of 2026, compared with a net loss of $27.9 million for the same period in 2025. The $2.4 million decrease was driven by a $7 million reduction in operating expenses, partially offset by a $5.1 million higher non-cash loss from the change in fair value of our warrant liabilities, with smaller movements in debt fair value and interest income.

Speaker #1: The decrease of $7.3 million was primarily related to reduced spending on our Revita and Rejuva programs. SG&A expenses were $5.3 million for the quarter, compared with $4.9 million for the same period in 2025.

Speaker #1: The increase of 0.4 million was primarily driven by higher stock compensation expense. We reported a net loss of 25.5 million for the second quarter of 2026, compared with a net loss of 27.9 million for the same period in 2025.

Lara Smith Weber: The increase of $0.4 million was primarily driven by higher stock compensation expense. We reported a net loss of $25.5 million for the Q2 of 2026, compared with a net loss of $27.9 million for the same period in 2025. The $2.4 million decrease was driven by a $7 million reduction in operating expenses, partially offset by a $5.1 million higher non-cash loss from the change in fair value of our warrant liabilities, with smaller movements in debt fair value and interest income.

Speaker #1: The 2.4 million decrease was driven by a 7 million reduction in operating expenses, partially offset by a 5.1 million higher non-cash loss from the change in fair value of our warrant liabilities, with smaller movements in debt fair value and interest income.

Speaker #1: Adjusted EBITDA was negative $16.3 million for the quarter, compared with negative $24 million in the second quarter of 2025, a $7.7 million improvement driven by reduced operating expenses excluding stock compensation.

Lara Smith Weber: Adjusted EBITDA was -$16.3 million for the quarter, compared with -$24 million in the Q2 of 2025, a $7.7 million improvement driven by reduced operating expenses excluding stock compensation. As of 30 June 2026, we had $47.1 million in cash and cash equivalents. I want to draw your attention to one point on run rate. Our Q1 carried certain one-time costs associated with completing REMAIN-1 pivotal cohort randomization. The Q2 does not. Cash used in operations was approximately $16 million in Q2, which is a better reflection of our post-randomization run rate than Q1. Based on our current business plans, we believe our cash position will fund operations into early 2027, beyond the anticipated REMAIN-1 pivotal data readout in early Q4 2026, and through a potential De Novo submission in late Q4. With that, I will turn it back to Harith.

Speaker #1: As of June 30, 2026, we had $47.1 million in cash and cash equivalents. I want to draw your attention to one point on run rate.

Speaker #1: Our first quarter carried certain one-time costs associated with completing remaining pivotal cohort randomization. The second quarter does not. Cash used in operations was approximately $16 million in Q2, which is a better reflection of our post-randomization run rate than Q1.

Lara Smith Weber: Cash used in operations was approximately $16 million in Q2, which is a better reflection of our post-randomization run rate than Q1. Based on our current business plans, we believe our cash position will fund operations into early 2027, beyond the anticipated REMAIN-1 pivotal data readout in early Q4 2026, and through a potential De Novo submission in late Q4. With that, I will turn it back to Harith.

Speaker #1: Based on our current business plans, we believe our cash position will fund operations into early 2027, beyond the anticipated remained one pivotal data readout in early Q4, 2026, and through a potential de novo submission in late Q4.

Speaker #1: With that, I'll turn it back to Harith.

Speaker #2: Thank you, Laura. Let me close where I started, with our four pillars. First, the clinical signal is real. We now have randomized, sham-controlled, one-year data showing 80% GLP-1–induced weight loss maintained, versus 46% with sham.

Harith Rajagopalan: Thank you, Lara. Let me close where I started with our four pillars. First, the clinical signal is real. We now have randomized sham-controlled one-year data showing 80% GLP-1 induced weight loss maintained versus 46% with sham. Second, the pivotal is built to win in that it is the same experiment run larger, powered above 95% on both co-primary endpoints, and enriched on both of the variables we now know drive effect size. The last six-month visit happens this month, and we remain on track to report top-line data in early Q4. Third, the path to commercial value is clear, and we are building on it now rather than waiting. The market already exists, the patients are already seeing GI physicians, and payers are converging on the need for a durable alternative. Fourth, we are funded through definitive data. Our runway extends into early 2027.

Speaker #2: Second, the pivotal is built to win. In the—it's the same experiment, run larger, powered above 95% on both co-primary endpoints, and enriched on both of the variables we now know drive effect size.

Speaker #2: The last six-month visit happens this month, and we remain on track to report top-line data in early Q4. Third, the path to commercial value is clear, and we are building on it now rather than waiting.

Harith Rajagopalan: The last six-month visit happens this month, and we remain on track to report top-line data in early Q4. Third, the path to commercial value is clear, and we are building on it now rather than waiting. The market already exists, the patients are already seeing GI physicians, and payers are converging on the need for a durable alternative. Fourth, we are funded through definitive data. Our runway extends into early 2027.

Speaker #2: The market already exists. The patients are already seeing GI physicians. And payers are converging on the need for a durable alternative. And fourth, we are funded through definitive data.

Speaker #2: Our runway extends into early 2027. There is no planned raise before pivotal data. I want to thank the patients in our pivotal study who have trusted us with their health and their persistence, and the investigators and operators who have executed this trial with real skill.

Harith Rajagopalan: There is no planned raise before pivotal data. I want to thank the patients in our pivotal study who have trusted us with their health and their persistence, and the investigators and operators who have executed this trial with real skill. I want to thank our employees whose focus through an unusually demanding stretch has been exceptional, and I want to thank our shareholders whose conviction in the science makes all of it possible. Operator, we are ready to take questions.

Speaker #2: I want to thank our employees whose focus through an unusually demanding stretch has been exceptional. And I want to thank our shareholders whose conviction in the science makes all of it possible.

Speaker #2: Operator, we are ready to take questions.

Speaker #3: 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.

Operator: 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 the Q&A roster. Our first question comes on line of Michael DiFiore of Evercore ISI. Your line is now open.

Speaker #3: To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. And our first question comes from the line of Michael DeFiore of Evercore ISI.

Speaker #3: Your line is now open.

Speaker #4: Hi guys. Thanks so much for taking my questions. Two for me. One regarding profitability. I think in the past you said that you believe that fragile can be profitable with a targeted launch into the top 100 to 200 US centers.

Michael DiFiore: Hey, guys. Thanks so much for taking my questions. Two for me. One regarding profitability. I think in the past you said that you believe that Fractyl Health can be profitable with a targeted launch into the top 100 to 200 US centers. My question is what procedure volume per center is embedded in that profitability assumption, and how quickly do you expect trained physicians to ramp to that level? Then I have a follow-up.

Michael DiFiore: Thanks so much for taking my questions. Two for me. One regarding profitability. I think in the past you said that you believe that Fractyl Health can be profitable with a targeted launch into the top 100 to 200 US centers. My question is what procedure volume per center is embedded in that profitability assumption, and how quickly do you expect trained physicians to ramp to that level? Then I have a follow-up.

Speaker #4: My question is, what procedure volume per center is embedded in that profitability assumption? And how quickly do you expect trained physicians to ramp to that level?

Speaker #4: And then I have a follow-up.

Speaker #2: Well, that's actually a wonderful question that preps for our investor day that's coming in early September, where we can address our view on the commercial opportunity ahead of us.

Harith Rajagopalan: Well, that's actually a wonderful question that preps for our investor day that's coming in early September, where we can address our view on the commercial opportunity ahead of us. I'm not going to front-run with specific numbers in that regard. I will say that embedded in that is also the health economic value from Revita, and we are finalizing our numbers now with 50 patients with one year of follow-up from REVEAL and REMAIN. We believe that the health economic value proposition is greater than we had previously realized. That helps us gain confidence in the potential profitability from the health economic value we can deliver. With respect to your question on training, as we've observed now across multiple studies, it takes less than 5 procedures for a physician to feel comfortable doing our procedure.

Harith Rajagopalan: That's actually a wonderful question that preps for our investor day that's coming in early September, where we can address our view on the commercial opportunity ahead of us. I'm not going to front-run with specific numbers in that regard. I will say that embedded in that is also the health economic value from Revita, and we are finalizing our numbers now with 50 patients with one year of follow-up from REVEAL and REMAIN.

Speaker #2: But I'm not going to front-run with specific numbers in that regard. I will say that that embedded in that is also the health economic value from Revita.

Speaker #2: And we are finalizing our numbers now with 50 patients with one year of follow-up from Reveal and Remain. We believe that the health economic value proposition is greater than we had previously realized.

Harith Rajagopalan: We believe that the health economic value proposition is greater than we had previously realized. That helps us gain confidence in the potential profitability from the health economic value we can deliver. With respect to your question on training, as we've observed now across multiple studies, it takes less than 5 procedures for a physician to feel comfortable doing our procedure.

Speaker #2: That helps us gain confidence in the potential profitability from the health economic value we can deliver. With respect to your question on training, as we've observed now across multiple studies, it takes less than five procedures for a physician to feel comfortable doing our procedure.

Speaker #2: We expect to continue the same preceptorship program that we ran in our pivotal study—quite successfully, I might add—as we get new physicians comfortable with using this procedure.

Harith Rajagopalan: We expect to continue the same preceptorship program that we ran in our pivotal study, quite successfully, I might add, as we get new physicians comfortable with using this procedure. The benefit that we have is that the procedure that we're asking them to learn how to do leverages existing skills, doesn't really ask them to do anything that they don't otherwise know how to do, and therefore can be very easy for them to intuitively understand what needs to happen. From a patient perspective, the advantage is that this is a one-time intervention that is not anatomy altering and has what we believe to be a very compelling safety profile.

Speaker #2: The benefit that we have is that the procedure we're asking them to learn leverages existing skills. It doesn't really ask them to do anything that they don't already know how to do.

Speaker #2: And therefore, it can be very easy for them to intuitively understand what needs to happen. From a patient perspective, the advantage is that this is a one-time intervention that is not anatomy-altering and has what we believe to be a very compelling safety profile.

Harith Rajagopalan: From a patient perspective, the advantage is that this is a one-time intervention that is not anatomy altering and has what we believe to be a very compelling safety profile. That's why we think it's going to be compelling to both physicians and patients, but more numbers on the model should be presented as a story in our investor day with an understanding of the health economic value as well.

Speaker #2: That's why we think it's going to be compelling to both physicians and patients. But more numbers on the model should be presented as a story in our Investor Day, with an understanding of the health economic value as well.

Harith Rajagopalan: That's why we think it's going to be compelling to both physicians and patients, but more numbers on the model should be presented as a story in our investor day with an understanding of the health economic value as well.

Speaker #4: Great. Thanks, Karith. I have one more follow-up question regarding reimbursement. Just trying to get a sense if there's any I guess remaining risk on the patient coverage side.

Michael DiFiore: Great. Thanks, Harith. I have one more follow-up question regarding reimbursement. Just trying to get a sense if there's any, I guess, remaining risk on the patient coverage side. What criteria do you expect payers or Medicare to impose around prior GLP-1 use, the degree of prior weight loss, BMI, documented discontinuation, et cetera, before reimbursing for Revita? Thank you.

Speaker #4: What criteria do you expect payers or Medicare to impose around prior GLP-1 use? For example, the degree of prior weight loss, BMI, documented discontinuation, et cetera, before reimbursing for Revita.

Speaker #4: Thank you.

Speaker #2: I expect that Medicare will follow, and I expect that payers will be looking very carefully at the patient population that was studied and pre-specified in the pivotal trial.

Harith Rajagopalan: I expect that Medicare will follow. I expect that payers will be looking very carefully at the patient population that was studied and pre-specified in the pivotal trial. While I can't speak to what the label might say, I would expect that the payers are going to look very carefully at this at least 15% run in weight loss and the use of a GLP-1 therapy or GLP-1 based therapy rather than tirzepatide specifically. This is an interesting conversation that we will look forward to having with pivotal data in-hand with payers. I can tell you that in the conversation we've had in the last quarter with payers, Medicare in particular is concerned about the muscle mass loss associated with the GLP-1s and the frailty as it particularly applies to the elderly population.

Speaker #2: And so, while I can't speak to what the label might say, I would expect that the payers are going to look very carefully at this—at least 15% run-in weight loss and the use of GLP-1 therapy or GLP-1-based therapy, rather than tirzepatide specifically.

Speaker #2: And this is an interesting conversation that we will look forward to having with pivotal data in hand with payers. I can tell you that in the conversations we've had in the last quarter with payers, Medicare in particular is concerned about the muscle mass loss associated with the GLP-1s and the frailty, as it particularly applies to the elderly population.

Harith Rajagopalan: This is an interesting conversation that we will look forward to having with pivotal data in-hand with payers. I can tell you that in the conversation we've had in the last quarter with payers, Medicare in particular is concerned about the muscle mass loss associated with the GLP-1s and the frailty as it particularly applies to the elderly population.

Speaker #2: Combined with the fact that they're expecting millions of people to start GLP-1s because of this bridge program, and because that program has a shelf life of about 18 months, there is clearly a view that a lot of patients will need to be discontinuing next year.

Harith Rajagopalan: Combined with the fact that they're expecting millions of people to start GLP-1s because of this bridge program and because that program has a shelf life of about 18 months, there is clearly a view that a lot of patients will be needing to be discontinuing next year, and they're thinking hard about what the implications of that are.

Speaker #2: And they're thinking hard about what the implications of that are.

Speaker #4: Very helpful. Thank you.

Michael DiFiore: 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 comes from the line of Jason Gerberry of Bank of America. 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. Your line is now open.

Speaker #2: Hey, guys. Thanks for taking my questions. Another one on reimbursement—you know, upon approval, what is the expectation in terms of how the Transitional Coverage for Emerging Technologies, given that you have breakthrough device designation?

Jason Gerberry: Hey, guys. Thanks for taking my questions. Another one on reimbursement. Upon approval, what is the expectation in terms of how the transitional coverage for emerging technologies, given that you have breakthrough device designation, are there any risks to that in terms of when you would be filing? Anything you need to be aware of in terms of the importance of filing timeline and/or De Novo versus a PMA filing? That is my first question. Secondly, you mentioned in the press release, the company building out commercial infrastructure for Revita as the data readouts approach. Can you maybe just elaborate a little bit more on those efforts? What sort of size of commercial infrastructure that you believe you will need to support Revita? Thanks.

Jason Gerberry: Thanks for taking my questions. Another one on reimbursement. Upon approval, what is the expectation in terms of how the transitional coverage for emerging technologies, given that you have breakthrough device designation, are there any risks to that in terms of when you would be filing?

Speaker #2: Are there any risks to that? You know, in terms of when you'd be filing, are there things you need to be aware of, in terms of the importance of filing timeline and/or de novo versus a PMA filing?

Jason Gerberry: Anything you need to be aware of in terms of the importance of filing timeline and/or De Novo versus a PMA filing? That is my first question. Secondly, you mentioned in the press release, the company building out commercial infrastructure for Revita as the data readouts approach. Can you maybe just elaborate a little bit more on those efforts? What sort of size of commercial infrastructure that you believe you will need to support Revita? Thanks.

Speaker #2: So that's my first question. And then secondly, you mentioned in the press release, you know, the company is building out commercial infrastructure for Revita as the data readouts approach.

Speaker #2: Can you maybe just elaborate a little bit more on those efforts? You know, what sort of size of commercial infrastructure do you believe you'll need to support Revita?

Speaker #2: Thanks.

Speaker #4: Sure. So with respect to initial payment, there is a mechanism called transitional pass-through through CMS. That has a quarterly review cycle and a statutory requirement for payment that is actually quite clear.

Harith Rajagopalan: Sure. With respect to initial payment, there is a mechanism called transitional pass-through through CMS that has a quarterly review cycle and a statutory requirement for payment that is actually quite clear. Breakthrough devices have an exemption through transitional pass-through, meaning that breakthrough devices that achieve regulatory clearance or approval are sort of automatically in scope, so long as they are novel and so long as the price of that novel device does not fit into an existing CPT schema. Ours, we believe, fits all of those criteria. The applications go in on a quarterly basis. They are reviewed in a rolling manner, and so every 3 months, new approved or cleared devices get transitional pass-through payment.

Harith Rajagopalan: Sure. With respect to initial payment, there is a mechanism called transitional pass-through through CMS that has a quarterly review cycle and a statutory requirement for payment that is actually quite clear. Breakthrough devices have an exemption through transitional pass-through, meaning that breakthrough devices that achieve regulatory clearance or approval are automatically in scope, so long as they are novel and so long as the price of that novel device does not fit into an existing CPT schema. Ours, we believe, fits all of those criteria.

Speaker #4: Breakthrough devices have an exemption for transitional pass-through, meaning that breakthrough devices that achieve regulatory clearance or approval are automatically in scope as long as they are novel.

Speaker #4: And as long as the price of that novel device doesn't fit into an existing CPT schema—so ours, we believe, fits all of those criteria.

Speaker #4: And so the applications go in on a quarterly basis. They are reviewed in a rolling manner. And so every three months, new transitional approved or cleared devices get transitional pass-through payment.

Harith Rajagopalan: The applications go in on a quarterly basis. They are reviewed in a rolling manner, and so every 3 months, new approved or cleared devices get transitional pass-through payment. We feel like the tailwinds are strong in that the CMS just issued a new rule reaffirming that transitional pass-through rule, that sort of criteria that I just laid out will be in place for the next several years, and we believe we will qualify once cleared.

Speaker #4: So we feel like the tailwinds are strong, in that CMS just issued a new rule reaffirming that the transitional pass-through rule criteria I just laid out will be in place for the next several years.

Harith Rajagopalan: We feel like the tailwinds are strong in that the CMS just issued a new rule reaffirming that transitional pass-through rule, that sort of criteria that I just laid out will be in place for the next several years, and we believe we will qualify once cleared. That allows us to have confidence that Revita can have reimbursement from day one at the time of launch, which is a really strong place to be. That ties to our view on the commercial infrastructure. We will have more to say about this in our September investor day. The high-level points that I would want to convey are that we envision a very targeted and efficient center of excellence model focused on hospitals where we already have very strong relationships.

Speaker #4: And we believe we will qualify once cleared, and that allows us to have confidence that Revita can have reimbursement from day one at the time of launch, which is a really strong place to be.

Harith Rajagopalan: That allows us to have confidence that Revita can have reimbursement from day one at the time of launch, which is a really strong place to be. That ties to our view on the commercial infrastructure. We will have more to say about this in our September investor day. The high-level points that I would want to convey are that we envision a very targeted and efficient center of excellence model focused on hospitals where we already have very strong relationships.

Speaker #4: And that ties to our view on the commercial infrastructure. We'll have more to say about this in our September Investor Day, but the high-level points that I'd want to convey are that we envision a very targeted and efficient center of excellence model focused on hospitals where we already have very strong relationships. As Mike alluded to earlier, the top 100 to 200 endoscopy health systems do at least half of the endoscopies in the United States.

Harith Rajagopalan: As Mike alluded to earlier, the top 100 to 200 endoscopy health systems do at least half of the endoscopies in the United States. All of these top centers have endoscopists who are focused on doing bariatric and metabolic endoscopy. We have strong relationships there, and we will initially focus on them because we believe that health systems can funnel patients in very efficiently, enabling us to launch with a smaller team that is highly focused on high throughput centers.

Speaker #4: And so, all of these top centers have endoscopists who are focused on doing bariatric and metabolic endoscopy. We have strong relationships there, and we will initially focus on them because we believe that health systems can funnel patients in very efficiently, enabling us to launch with a smaller team that's highly focused on high-throughput centers.

Speaker #3: Thank you. One moment for our next question. Our next question comes from the line of Chase Nicaragua of Greg Holland. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Chase Nickerbacker of Greg Holland. Your line is now open.

Speaker #5: Good afternoon. Thanks for taking the questions. Maybe just first from me: could you confirm whether or not the final SAP was submitted, and if there was any response or correspondence with the agency as it relates to some of the recent tweaks?

Chase Nickerbacker: Good afternoon. Thanks for taking the questions. Maybe just first from me, could you just confirm whether or not the final SAP was submitted and if there was any response or correspondence with the agency as it relates to some of the recent tweaks? Thanks.

[Analyst] (Greg Holland): Good afternoon. Thanks for taking the questions. Maybe just first from me, could you just confirm whether or not the final SAP was submitted and if there was any response or correspondence with the agency as it relates to some of the recent tweaks? Thanks.

Speaker #5: Thanks.

Speaker #2: Yes. Final SAP was submitted. I think we mentioned that in our July call. And we are locked and loaded heading into our database lock, you know, in the next several weeks.

Harith Rajagopalan: Yes. Final SAP was submitted. I think we mentioned that in our July call, and we are locked and loaded heading into our database lock in the next several weeks.

Speaker #5: Was there any response or kind of correspondence with the FDA as it, you know, kind of, around that?

Chase Nickerbacker: Was there any response or kind of correspondence with FDA around that?

[Analyst] (Greg Holland): Was there any response or kind of correspondence with FDA around that?

Speaker #2: There was. There was—there was clearly a response from the FDA. It's all sort of within the nuances. I would say that it was down in the schema of details, rather than high-level.

Harith Rajagopalan: There was. There was clearly a response from the FDA. It is all sort of within the nuances. I would say that it was down in the schema of details rather than high level. Nothing of materiality for us to discuss.

Speaker #2: Nothing of materiality for us to discuss.

Speaker #5: Great. And then just last, a little bit of a kind of bigger question bigger picture question. But can you just remind us, you know, kind of the extent of your patent to state as it relates to kind of other you know, kind of ablation technologies you know, particularly as it relates to weight maintenance as we think about, you know, now having a de novo approval rather than a PMA?

Chase Nickerbacker: Great. Just last, a little bit of a kind of bigger picture question. Can you just remind us kind of the extent of your patent estate as it relates to kind of other ablation technologies, particularly as it relates to weight maintenance? As we think about now having a De Novo approval rather than a PMA, can you just kind of speak to your patent protection?

[Analyst] (Greg Holland): Great. Just last, a little bit of a kind of bigger picture question. Can you just remind us kind of the extent of your patent estate as it relates to kind of other ablation technologies, particularly as it relates to weight maintenance? As we think about now having a De Novo approval rather than a PMA, can you just kind of speak to your patent protection?

Speaker #5: Can you speak to your patent protection?

Speaker #2: Sure. Well, one thing that I would say at a very high level is that we have a very broad and comprehensive patent estate, which ties to our company being the leader in innovation in this category.

Harith Rajagopalan: Well, one thing that I would say at a very high level is that we have a very broad and comprehensive patent estate that ties to our company being the leader in innovation in this category, and being the first to develop any form of ablation efforts for the duodenum, whether that is in type 2 diabetes or in weight maintenance or in NAFLD/NASH or other metabolic conditions that you could imagine. We have issued patents in the United States that cover not only our methods and our specific devices, but also broadly covering both thermal and non-thermal ablation modalities, not only for post GLP-1 weight maintenance, but also for type 2 diabetes and related conditions. So we believe that we have a very strong patent estate covering any manner of ablation modality, and we intend to defend that market.

Harith Rajagopalan: One thing that I would say at a very high level is that we have a very broad and comprehensive patent estate that ties to our company being the leader in innovation in this category, and being the first to develop any form of ablation efforts for the duodenum, whether that is in type 2 diabetes or in weight maintenance or in NAFLD/NASH or other metabolic conditions that you could imagine.

Speaker #2: And being the first to develop any form of ablation efforts for the duodenum, whether that's in type 2 diabetes or in weight maintenance, or in NAFLD, NASH, or other metabolic conditions that you could imagine.

Speaker #2: And we have issued patents in the United States that cover not only our methods and our specific devices, but also broadly cover both thermal and non-thermal ablation modalities, not only for post-GLP-1 weight maintenance, but also for type 2 diabetes and related conditions.

Harith Rajagopalan: We have issued patents in the United States that cover not only our methods and our specific devices, but also broadly covering both thermal and non-thermal ablation modalities, not only for post GLP-1 weight maintenance, but also for type 2 diabetes and related conditions. So we believe that we have a very strong patent estate covering any manner of ablation modality, and we intend to defend that market.

Speaker #2: So we believe that we have a very strong patent estate covering any manner of ablation modality, and we intend to defend that market. Thank you.

Chase Nickerbacker: Great. Thanks, Harith.

[Analyst] (Greg Holland): Great. Thanks, Harith.

Harith Rajagopalan: Thank you.

Speaker #3: Thank you. One moment for our next question. Our next question comes from the line of Winnie Ijam of Kennecourt January. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Whitney Ijem of Canaccord Genuity. Your line is now open.

Speaker #6: Hey guys, thanks for taking our question. This is Angela on for Whitney. So, you talked earlier in the call about more patients being on GLP-1 injectables or orals now.

[Analyst] (Canaccord Genuity): Hey, guys. Thanks for taking our question. This is Angela on for Whitney. You talked earlier in the call about more patients being on GLP-1 injectable or orals now, and that each patient is a future discontinuation, so the addressable market has really also expanded. Curious, though, from your market research, are you seeing patients perhaps maybe stay on drug longer, or is that discontinuation rate still about the same at 1 year? Just thinking about physicians now having more experience with this class of medications and being able to titrate.

Whitney Ijem: Thanks for taking our question. This is Angela on for Whitney. You talked earlier in the call about more patients being on GLP-1 injectable or orals now, and that each patient is a future discontinuation, so the addressable market has really also expanded. Curious, though, from your market research, are you seeing patients perhaps maybe stay on drug longer, or is that discontinuation rate still about the same at 1 year? Just thinking about physicians now having more experience with this class of medications and being able to titrate.

Speaker #6: And that each patient is a future discontinuation. So, the addressable market has really also expanded. Curious though, from your market research, are you seeing patients perhaps maybe staying on drugs longer?

Speaker #6: Or is that discontinuation rate still about the same at one year—just, you know, thinking about physicians now having more experience with this class of medications and being able to titrate?

Speaker #2: The data that I'm seeing is that patients—based on all the meta-analyses I'm seeing—are now suggesting that the median duration of time on therapy is still in the six- to nine-month range.

Harith Rajagopalan: The data that I am seeing is that all the meta-analyses I am seeing are now suggesting that the median duration of time on therapy is still in the six to nine-month range. I have not seen anything change, but I would also say the quality of our data is more impaired because of more people getting drugs from online pharmacies. The best data that we have suggests that people are on drug for about six to nine months. I am very intrigued to see, but it is too early to tell, what that median duration of therapy will be on orals. Preliminarily, what we are seeing with orals is that people are staying on lower doses or not titrating nearly as much as one might have expected.

Speaker #2: I have not seen anything change, but I would also say the quality of our data is more impaired because more people are getting drugs from online pharmacies.

Speaker #2: And so the best data that we have suggests that people are on drugs for about six to nine months. And I I'm very intrigued to see but it's too early to tell what that median duration of therapy will be on orals but preliminarily what we are seeing with orals is that people are staying on lower doses or or not titrating nearly as much as one might have expected.

Harith Rajagopalan: The best data that we have suggests that people are on drug for about six to nine months. I am very intrigued to see, but it is too early to tell, what that median duration of therapy will be on orals. Preliminarily, what we are seeing with orals is that people are staying on lower doses or not titrating nearly as much as one might have expected. We are going to be continuing to follow that very carefully and then thinking about how that models into our estimation of the total market size.

Speaker #2: And so we are going to be continuing to follow that very carefully and then thinking about how that models into our estimation of the total market size.

Harith Rajagopalan: We are going to be continuing to follow that very carefully and then thinking about how that models into our estimation of the total market size. The million discontinuers a month, I think, is still the most jaw-dropping number and important to think about because these patients, if they have been on drug for six to nine months, have probably gotten to clinically meaningful weight loss, and now are facing rapid weight regain based on what we have seen in our own clinical trials. It is happening in the sham arm in these patients. I expect that is happening consistent with what is happening in the real world. We think we have a really huge opportunity here.

Speaker #2: But the million discontinuers a month I think is still like the most jaw-dropping number and important to think about because these patients if they've been on drugs for six to nine months have probably gotten to clinically meaningful weight loss and now are facing you know, rapid weight regain based on what we've seen in our own clinical trials.

Harith Rajagopalan: The million discontinuers a month, I think, is still the most jaw-dropping number and important to think about because these patients, if they have been on drug for six to nine months, have probably gotten to clinically meaningful weight loss, and now are facing rapid weight regain based on what we have seen in our own clinical trials. It is happening in the sham arm in these patients. I expect that is happening consistent with what is happening in the real world. We think we have a really huge opportunity here.

Speaker #2: It's happening in the sham arm in these patients. I expect that's happening consistent with what was happening in the real world. We think we have a really huge opportunity here.

Speaker #3: Thank you. One moment for our next question. Our next question comes from 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 Tusing of Morgan Stanley. Your line is now open.

Speaker #4: Hi, this is Rohit. Over to Mike. Thanks for taking our questions. On Revita, can you just talk about any early thoughts on pricing? And then on Rejuva, what kind of preliminary data should we expect later this year?

[Analyst] (Morgan Stanley): Hi, this is Rohit on for Mike. Thanks for taking our questions. On Revita, can you just talk about any early thoughts on pricing? On Rejuva, what kind of preliminary data should we expect later this year? Thanks.

[Analyst] (Morgan Stanley): This is Rohit on for Mike. Thanks for taking our questions. On Revita, can you just talk about any early thoughts on pricing? On Rejuva, what kind of preliminary data should we expect later this year? Thanks.

Speaker #4: Thanks.

Speaker #2: Okay, so on Revita pricing, the health economic analysis that we're doing will be presented at our investor day later this month.

Harith Rajagopalan: Okay. On Revita pricing, the health economic analysis that we are doing, we are going to be presenting in our investor day later this month. It is a bit premature for me to give you that number. But we can present our view on the health economic value proposition. We will be planning to do so in just a few weeks. With respect to Rejuva, I would point you to our earlier statement that the first most important thing for us to communicate is the safety and tolerability of RJVA-001 through that first 14-day sentinel period, and the safety and feasibility of the Revita device delivery. That is the most important thing, because that is what unlocks the rest of the dosing in the dosing cohort. I would point you to that as the first thing that we are going to be communicating.

Speaker #2: So it's a bit premature for me to give you that number. But we can present our view on the health economic value proposition, and we will be planning to do so in just a few weeks.

Speaker #2: With respect to Rejuva, I would point you to our earlier statement that like the first most important thing for us to communicate is the safety and tolerability of Rejuva 001 through that first 14-day sentinel period and the safety and feasibility of the Revita device delivery.

Harith Rajagopalan: With respect to Rejuva, I would point you to our earlier statement that the first most important thing for us to communicate is the safety and tolerability of RJVA-001 through that first 14-day sentinel period, and the safety and feasibility of the Revita device delivery. That is the most important thing, because that is what unlocks the rest of the dosing in the dosing cohort. I would point you to that as the first thing that we are going to be communicating.

Speaker #2: And that that's the most important thing because that's what unlocks the rest of the dosing in the dosing cohort. And so I would point you to that as the first thing that we're going to be communicating.

Speaker #4: Thank you.

[Analyst] (Morgan Stanley): Thank you.

Speaker #3: Thank you. One moment for our next question. Our next question comes from the line of Jeffrey Cohen of Ladenburg Thalmann. 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. Your line is now open.

Speaker #5: Hello, Harith and Laura. Thanks for taking our questions. To firstly, although it's a secondary endpoint, could you comment at all on HbA1c and what you would anticipate the the the readout of Revita in early Q4 would show?

Jeffrey Cohen: Hello, Harith and Lara. Thanks for taking our questions. Two. Firstly, although it is a secondary endpoint, could you comment at all on HbA1c and what you would anticipate the readout of Revita in early Q4 would show? Would you expect that to be comparable with previous cohorts?

Speaker #5: And would you expect that to be comparable with previous cohorts?

Speaker #2: Uh-huh. So we we do have secondary analyses in the remaining pivotal study for effects on cardiometabolic parameters. Lipids like HDL and triglycerides and HbA1c.

Harith Rajagopalan: We do have secondary analyses in the REMAIN pivotal study for effects on cardiometabolic parameters, lipids like HDL and triglycerides, and HbA1c. This is a patient population that does have a fair amount of obesity-related comorbidity, but very few of these patients actually were diagnosed with pre-diabetes at the time of randomization. The signal that we would hope to be able to show is glycemic stability through 6 months in that blinded randomized trial. I don't think the HbA1cs at the time of randomization were very high. They're in the low 5s. I don't think you're going to expect to see something more than glycemic stability.

Speaker #2: This is a patient population that does have like a fair amount of obesity-related comorbidity. But very few of these patients actually were diagnosed with prediabetes at the time of randomization.

Speaker #2: And so, the signal that we would hope to be able to show is glycemic stability through six months in that blinded, randomized trial.

Harith Rajagopalan: The signal that we would hope to be able to show is glycemic stability through 6 months in that blinded randomized trial. I don't think the HbA1cs at the time of randomization were very high. They're in the low 5s.

Speaker #2: I don't think the HbA1c's at the time of randomization were very high. They were in the low fives. And so I'm not—I don't think you're going to expect to see something more than glycemic stability.

Harith Rajagopalan: I don't think you're going to expect to see something more than glycemic stability. Which I think alone is a very valuable thing, because these patients are at high risk of going on to developing pre-diabetes, and that will take more time to mature in a clinical signal than the 6-month readout is going to give you.

Speaker #2: Which I think alone is a very valuable thing because what it because these patients are at high risk of going on to developing prediabetes and that will take more time to mature in a clinical signal than the six-month readout is going to give you.

Harith Rajagopalan: Which I think alone is a very valuable thing, because these patients are at high risk of going on to developing pre-diabetes, and that will take more time to mature in a clinical signal than the 6-month readout is going to give you.

Speaker #5: Okay. That's helpful. And then as a follow-up, could you jump over to Rejuva for a moment? So I think the the Netherlands study is three cohorts, three patients, with an additional 20 behind that.

Jeffrey Cohen: Okay, that's helpful. As a follow-up, could you jump over to Rejuva for a moment? I think the Netherlands study is 3 cohorts, 3 patients with an additional 20 behind that. What's expected for Australia?

Speaker #5: What's expected for Australia?

Speaker #2: Well, it's all one study actually. So the it's not just Netherlands and there are multiple sites in international in an international study. And so each patient across this each cohort across the study will have each cohort will have three patients.

Harith Rajagopalan: Well, it's all one study, actually. It's not just Netherlands. There are multiple sites in an international study, and so each cohort across the study will have 3 patients across the study, whether it's in Netherlands or Australia or elsewhere.

Harith Rajagopalan: It's all one study, actually. It's not just Netherlands. There are multiple sites in an international study, and so each cohort across the study will have 3 patients across the study, whether it's in Netherlands or Australia or elsewhere.

Speaker #2: Across the study, whether it's in the Netherlands, Australia, or elsewhere.

Speaker #5: So we'd anticipate seeing nine patients by the end of the year.

Jeffrey Cohen: So we would anticipate seeing nine patients by the end of the year?

Speaker #2: No, no. We have to dose the first patient, wait 14 days, see a safety signal before we can dose anybody else. And so this is going so I think the thing to focus on, as I mentioned, is initial safety and feasibility of the device delivery and then safety and tolerability in that first sentinel patient through 14 days.

Harith Rajagopalan: No, we have to dose the first patient, wait 14 days, see a safety signal before we can dose anybody else. I think the thing to focus on, as I mentioned, is initial safety and feasibility of the device delivery, and then safety and tolerability in that first sentinel patient through 14 days. That is the thing that is going to give us the necessary information that would then allow the dosing of additional patients based on the protocol.

Speaker #2: That is the thing that is going to give us the necessary information that would then allow the dosing of additional patients, based on the protocol.

Speaker #5: Got it. Thanks for the clarification. Thanks for taking our questions.

Jeffrey Cohen: Got it. Thanks for the clarification. Thanks for taking our questions.

Speaker #2: Thank you.

Harith Rajagopalan: Thank you.

Speaker #3: Thank you. One moment for our next question. Our next question comes on the line of Joe Pangianis of 18 Wainwright. Your line is now open.

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

Speaker #6: Hey, guys. Good afternoon. Thanks for taking the question. So, my questions are both regulatory-based. So first, with Revita, I'm curious—what would you describe as the key outstanding point or points regarding going down the de novo status?

Joe Pantginis: Hey, guys. Good afternoon. Thanks for taking the question. My questions are both regulatory based. First, with Revita, curious, what would you describe as the key outstanding point or points with regard to going down the De Novo status, number one, and then what would you describe as the key point to be able to get to IND status in your discussions with the FDA? Thanks a lot.

Joe Pantginis: Good afternoon. Thanks for taking the question. My questions are both regulatory based. First, with Revita, curious, what would you describe as the key outstanding point or points with regard to going down the De Novo status, number one, and then what would you describe as the key point to be able to get to IND status in your discussions with the FDA? Thanks a lot.

Speaker #6: Number one, and then what would you describe as the key points to be able to get to IND status in your discussions with the FDA?

Speaker #6: Thanks a lot.

Speaker #2: Okay. So the key point to get Revita de novo is their review of our safety data from our pivotal study. That's very clear. That's going to go with in with the submission.

Harith Rajagopalan: Well, the key point to get Revita De Novo is their review of our safety data from our pivotal study. That is very clear. That is going to go in with the submission, and given the fact we have only seen blinded safety data with DSMB regular reviews, we are very encouraged by the safety profile in the blinded analysis. The FDA will need to review that and then make a final determination. We feel good about where we stand. With respect to Rejuva, our plan will be to generate safety, feasibility, and preliminary efficacy data from this OUS first-in-human study before coming to talk to the FDA. We do not yet have a timeline for you on when that will be.

Harith Rajagopalan: The key point to get Revita De Novo is their review of our safety data from our pivotal study. That is very clear. That is going to go in with the submission, and given the fact we have only seen blinded safety data with DSMB regular reviews, we are very encouraged by the safety profile in the blinded analysis.

Speaker #2: And given the fact we have only seen blinded safety data, with DSMB regular reviews, we are very encouraged by the safety profile in the blinded analysis.

Speaker #2: The FDA will need to review that and then make a final determination. We feel good about where we stand. With respect to Rejuva, our plan will be to generate safety, feasibility, and preliminary efficacy data from this OUS first-in-human study before coming to talk to the FDA.

Harith Rajagopalan: The FDA will need to review that and then make a final determination. We feel good about where we stand. With respect to Rejuva, our plan will be to generate safety, feasibility, and preliminary efficacy data from this OUS first-in-human study before coming to talk to the FDA. We do not yet have a timeline for you on when that will be.

Speaker #2: We don't yet have a timeline for you on when that will be.

Speaker #6: Got it. Appreciate the details, Harith.

Joe Pantginis: Got it. Appreciate the details, Harith.

Speaker #2: Yeah. Thank you.

Harith Rajagopalan: Yeah. Thank you.

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

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

Speaker #2: Well, thank you, everyone. Investor Day is next month. I appreciate the commercial questions and look forward to discussing them in much more detail with you in early September.

Harith Rajagopalan: Well, thank you everyone. Investor Day next month. Appreciate the commercial questions. Look forward to discussing them in much more detail with you in early September. Top line pivotal data in early Q4. Potential De Novo submission late Q4. We are one quarter away from the most important question in obesity. Thank you all.

Harith Rajagopalan: Thank you everyone. Investor Day next month. Appreciate the commercial questions. Look forward to discussing them in much more detail with you in early September. Top line pivotal data in early Q4. Potential De Novo submission late Q4. We are one quarter away from the most important question in obesity. Thank you all.

Speaker #2: Topline pivotal data in early Q4. Potential de novo submission late Q4. We are one quarter away from the most important question in obesity. Thank you all.

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

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