Fractyl Health Q2 2026 Earnings Report

Fractyl Health EPS Results

• Actual EPS: -$0.12
• Consensus EPS: -$0.14
• Beat/Miss: Beat by +$0.02
• One Year Ago EPS: N/A

Fractyl Health Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Fractyl Health Announcement Details

• Quarter: Q2 2026
• Date: 8/10/2026
• Time: After Market Closes
• Conference Call Date: Monday, August 10, 2026
• Conference Call Time: 4:30PM ET

Fractyl Health (NASDAQ:GUTS) is a clinical-stage medical technology company focused on the development and commercialization of minimally invasive, endoscopic therapies for metabolic diseases. Headquartered in Lexington, Massachusetts, Fractyl is advancing treatments that target the underlying physiology of conditions such as type 2 diabetes, obesity and nonalcoholic fatty liver disease (NAFLD) by modifying the duodenal mucosa to improve metabolic control.

The company’s lead product, Revita® Duodenal Mucosal Resurfacing (Revita DMR), employs a catheter-based hydrothermal ablation technique to remodel the lining of the upper small intestine. This outpatient procedure is designed to interrupt disease-driving signals between the gut and the liver, pancreas and brain, with the aim of improving glycemic control and reducing liver fat. Fractyl has conducted multiple clinical trials across North America, Europe and Asia, and holds CE mark approval in the European Union for Revita DMR.

Fractyl Health is also developing next-generation therapies and combination approaches to expand the reach of its duodenal resurfacing technology. The company has initiated pivotal studies to support U.S. regulatory filings and is preparing for broader commercial roll-out following anticipated approvals. Fractyl’s management team includes industry veterans in interventional gastroenterology, clinical development and medical device commercialization, positioning the company to address the growing global burden of metabolic disease.

Fractyl Health Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Revita’s one-year randomized data showed durable weight maintenance: patients retained more than 80% of prior GLP-1-induced weight loss versus 46% for sham, with no device- or procedure-related serious adverse events reported.
• Positive Sentiment: The company said the REMAIN-1 pivotal trial is fully randomized with more than 300 participants across 30-plus sites, and remains on track to report six-month top-line data in early Q4 2026 and potentially submit for FDA De Novo authorization in late Q4.
• Positive Sentiment: Management sees a sizable commercial opportunity driven by continued GLP-1 use and discontinuation, payer concerns over indefinite treatment costs and frailty, and a targeted center-of-excellence launch model with potential CMS transitional pass-through reimbursement.
• Neutral Sentiment: Fractyl ended Q2 with $47.1 million in cash and said its runway extends into early 2027, beyond pivotal data and a potential De Novo submission; however, the regulatory pathway remains contingent on FDA review of the complete safety dataset, and no capital raise is planned before pivotal data.
• Positive Sentiment: The company received authorization in the Netherlands and ethics approval in Australia to begin the first-in-human Phase I/II study of its Rejuva gene-therapy candidate, with initial safety and delivery-feasibility data expected in the second half of 2026.

Presentation

[Operator]

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. 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.

[Brian Luque, Head of Investor Relations and Corporate Development at Fractyl Health]

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, Head of Investor Relations and Corporate Development at Fractyl Health]

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

[Harith Rajagopalan, CEO at Fractyl Health]

Thank you, Brian. Good afternoon, everyone. Nearly 30 million Americans are now on GLP-1 therapy. Approximately one 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.

[Harith Rajagopalan, CEO at Fractyl Health]

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 one, the clinical signal is real. On July 15, we reported one-year randomized data from the REMAIN-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? 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 six through month 12 under maintained blinding in a cohort where not one patient reinitiated GLP-1 therapy.

[Harith Rajagopalan, CEO at Fractyl Health]

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. So we now have two different patient populations showing one year of durable weight maintenance and 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? Dr. Adarsh Thaker 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 one-year mark. 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 study is enriched for.

[Harith Rajagopalan, CEO at Fractyl Health]

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 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 resolved within two 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. GLP-1 medicines are associated with high rates of GI adverse events. The more potent the agent, the more adverse events.

[Harith Rajagopalan, CEO at Fractyl Health]

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 two, 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. We completed randomization in February with more than 300 participants across more than 30 sites with more than 20 operators.

[Harith Rajagopalan, CEO at Fractyl Health]

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've generated to date, we estimate both are well powered above 95%. 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. The second is the responder rate.

[Harith Rajagopalan, CEO at Fractyl Health]

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. 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 REMAIN-1 pivotal cohort in Q1 2027.

[Harith Rajagopalan, CEO at Fractyl Health]

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 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. We will take you through the detail at our Investor Day in September. First, the market opportunity is well understood by all key stakeholders.

[Harith Rajagopalan, CEO at Fractyl Health]

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. 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.

[Harith Rajagopalan, CEO at Fractyl Health]

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. 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.

[Harith Rajagopalan, CEO at Fractyl Health]

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. 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. 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.

[Harith Rajagopalan, CEO at Fractyl Health]

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 the second quarter versus the first 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. 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.

[Harith Rajagopalan, CEO at Fractyl Health]

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. 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, CEO at Fractyl Health]

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 activation and patient enrollment, and to report preliminary data in the second half 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. 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 six-month randomized data from the REMAIN-1 pivotal cohort.

[Harith Rajagopalan, CEO at Fractyl Health]

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

[Lara Smith Weber, CFO at Fractyl Health]

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. 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 second quarter 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

[Lara Smith Weber, CFO at Fractyl Health]

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. As of June 30th, 2026, we had $47.1 million in cash and cash equivalents. I want to draw your attention to one point on run rate. Our first quarter carried certain one-time costs associated with completing REMAIN-1 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. 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'll turn it back to Harith.

[Harith Rajagopalan, CEO at Fractyl Health]

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'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. 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.

[Harith Rajagopalan, CEO at Fractyl Health]

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. I want to thank our shareholders, whose conviction in this science makes all of it possible. Operator, we are ready to take questions.

[Operator]

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

[Michael Dufour, Analyst at Evercore ISI]

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 can be profitable with a targeted launch into the top 100 to 200 U.S. 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.

[Harith Rajagopalan, CEO at Fractyl Health]

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 five procedures for a physician to feel comfortable doing our procedure.

[Harith Rajagopalan, CEO at Fractyl Health]

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. That's why we think it's going to be compelling to both physicians and patients.

[Harith Rajagopalan, CEO at Fractyl Health]

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.

[Michael Dufour, Analyst at Evercore ISI]

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. Like 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.

[Harith Rajagopalan, CEO at Fractyl Health]

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.

[Harith Rajagopalan, CEO at Fractyl Health]

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.

[Michael Dufour, Analyst at Evercore ISI]

Very helpful. Thank you.

[Harith Rajagopalan, CEO at Fractyl Health]

Thank you.

[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.

[Jason Gerberry, Analyst at Bank of America]

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.

[Harith Rajagopalan, CEO at Fractyl Health]

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. The applications go in on a quarterly basis. They are reviewed in a rolling manner, and every three months, new approved or cleared devices get transitional pass-through payment.

[Harith Rajagopalan, CEO at Fractyl Health]

We feel like the tailwinds are strong in that the CMS just issued a new rule reaffirming that transitional pass-through rule, that 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, but 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.

[Harith Rajagopalan, CEO at Fractyl Health]

As Mike alluded to earlier, the top 100 to 200 endoscopy health systems do at least half of the endoscopies in the U.S. 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.

[Operator]

Thank you. One moment for our next question. Our next question comes from the line of Chase Knickerbocker of Craig-Hallum. Your line is now open.

[Chase Knickerbocker, Analyst at Craig-Hallum]

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.

[Harith Rajagopalan, CEO at Fractyl Health]

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.

[Chase Knickerbocker, Analyst at Craig-Hallum]

Was there any response or kind of correspondence with FDA as it was kind of around that?

[Harith Rajagopalan, CEO at Fractyl Health]

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. Nothing of materiality for us to discuss.

[Chase Knickerbocker, Analyst at Craig-Hallum]

Great. Just last, a little bit of a kind of bigger picture question. Can you just remind us the extent of your patent estate as it relates to other kind of 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 speak to your patent protection?

[Harith Rajagopalan, CEO at Fractyl Health]

Sure. 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's 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 U.S. 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.

[Chase Knickerbocker, Analyst at Craig-Hallum]

Great. Thanks, Harith.

[Harith Rajagopalan, CEO at Fractyl Health]

Thank you.

[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.

[Analyst at 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 one year? Just thinking about physicians now having more experience with this class of medications and being able to titrate.

[Harith Rajagopalan, CEO at Fractyl Health]

The data that I'm seeing is that patients are 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. 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'm very intrigued to see, but it's too early to tell, what that median duration of therapy will be on orals. Preliminarily, what we're seeing with orals is that people are staying on lower doses or not titrating nearly as much as one might have expected.

[Harith Rajagopalan, CEO at Fractyl Health]

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

[Operator]

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

[Analyst at Morgan Stanley]

Hi, this is Rohan 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.

[Harith Rajagopalan, CEO at Fractyl Health]

Okay. So on Revita pricing, the health economic analysis that we're doing, we're going to be presenting in our Investor Day later this month. It's 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's the most important thing because that's what unlocks the rest of the dosing in the dosing cohort. So I would point you to that as the first thing that we're going to be communicating.

[Analyst at Morgan Stanley]

Thank you.

[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.

[Jeffrey Cohen, Analyst at Ladenburg Thalmann]

Hello, Harith and Lara. Thanks for taking our questions. Two, firstly, although it's 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?

[Harith Rajagopalan, CEO at Fractyl Health]

So 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 six months in that blinded randomized trial. I don't think the HbA1cs at the time of randomization were very high. They were in the low fives.

[Harith Rajagopalan, CEO at Fractyl Health]

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 six-month readout is going to give you.

[Jeffrey Cohen, Analyst at Ladenburg Thalmann]

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

[Harith Rajagopalan, CEO at Fractyl Health]

Well, it's all one study, actually. It's not just Netherlands. There are multiple sites in an international study. Each cohort across the study will have three patients across the study, whether it's in Netherlands or Australia or elsewhere.

[Jeffrey Cohen, Analyst at Ladenburg Thalmann]

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

[Harith Rajagopalan, CEO at Fractyl Health]

No, 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.

[Jeffrey Cohen, Analyst at Ladenburg Thalmann]

Got it. Thanks for the clarification. Thanks for taking our questions.

[Harith Rajagopalan, CEO at Fractyl Health]

Thank you.

[Operator]

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

[Joe Pantginis, Analyst at H.C. Wainwright]

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 points to be able to get to IND status in your discussions with the FDA? Thanks a lot.

[Harith Rajagopalan, CEO at Fractyl Health]

Okay. 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 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 don't yet have a timeline for you on when that will be.

[Joe Pantginis, Analyst at H.C. Wainwright]

Got it. Appreciate the details, Harith.

[Harith Rajagopalan, CEO at Fractyl Health]

Yeah. Thank you.

[Operator]

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

[Harith Rajagopalan, CEO at Fractyl Health]

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.

[Operator]

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

Participants

Executives

• Brian Luque, Head of Investor Relations and Corporate Development
• Harith Rajagopalan, CEO
• Lara Smith Weber, CFO

Analysts

• Michael Dufour, Analyst at Evercore ISI
• Jason Gerberry, Analyst at Bank of America
• Chase Knickerbocker, Analyst at Craig-Hallum
• Analyst at Canaccord Genuity
• Analyst at Morgan Stanley
• Jeffrey Cohen, Analyst at Ladenburg Thalmann
• Joe Pantginis, Analyst at H.C. Wainwright