Fractyl Health Q1 2025 Earnings Report

Fractyl Health EPS Results

• Actual EPS: -$0.49
• Consensus EPS: -$0.49
• Beat/Miss: Met Expectations
• 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: Q1 2025
• Date: 5/13/2025
• Time: After Market Closes
• Conference Call Date: Tuesday, May 13, 2025
• Conference Call Time: 4:30PM ET

Fractyl Health (NASDAQ:GUTS), a metabolic therapeutics company, develops therapies for the treatment of type 2 diabetes (T2D) and obesity. The company develops Revita DMR System (Revita), an outpatient procedural therapy designed to durably modify duodenal dysfunction, a pathologic consequence of a high fat and high sugar diet, which can initiate T2D and obesity in humans. It also develops Rejuva, a novel adeno-associated virus delivered pancreatic gene therapy platform that is designed to enable long-term remission of T2D and obesity by durably altering metabolic hormone function in the pancreatic islet cells of patients. Fractyl Health, Inc. was formerly known as Fractyl Laboratories Inc. and changed its name to Fractyl Health, Inc. on June 09, 2021. The company was incorporated in 2010 and is headquartered in Burlington, Massachusetts.

Fractyl Health Q1 2025 Earnings Call Transcript

Key Takeaways

• Fractal completed full enrollment in the REMAIN-1 pivotal cohort in nine months—about three months ahead of schedule—and expects to finalize randomization in H1 2026 with six-month primary endpoint data in H2 2026, plus blinded midpoint data from 45 patients in Q3 2025.
• Early REVEAL-1 cohort results showed just 1.2% average weight regain at one month post-GLP-1 discontinuation versus ~3% historically, and the company will present three-month follow-up data in June 2025.
• The REJUVA-1 gene therapy platform outperformed semaglutide in preclinical models—preserving lean mass and delivering durable GLP-1 expression—and has secured European regulatory alignment, plans a CTA submission in June 2025, aims to dose first patients in 2026, and has scalable 500 L cGMP manufacturing established.
• In Q1 2025, R&D spending rose to $19.4 million (from $14.4 million YoY) to advance Revita and Rejuva, SG&A expenses declined, net loss was $23.7 million, and $42.1 million in cash funds operations into Q4 2025.

Presentation

[Operator]

Good afternoon, and welcome to Fractal Health's First Quarter twenty twenty five Financial Results and Business Updates Call. As a reminder, this conference call is being recorded. At this time, all participants are in listen only mode. There will be a question and answer session following management's prepared remarks. I'll now turn the call over to Brian Lucay, Head of Investor Relations and Corporate Development at Fractal.

[Operator]

Brian, you may now begin.

[Brian Luque, Head - IR & 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.fractal.com under the Investors tab. Joining us on the call today are Doctor. Harith Rajagopalan, Chief Executive Officer and Lisa Davidson, Chief Financial Officer.

[Brian Luque, Head - IR & Corporate Development at Fractyl Health]

During this call, we make forward looking statements, involve risks and uncertainties that may cause actual results to differ materially from our forward looking statements. We provide a comprehensive list of risk factors in our SEC filings, including the quarterly report on Form 10 Q filed today, which I encourage you to review. Any forward looking statements on the call are subject to substantial risks and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of the statements, even if subsequent events cause the company's views to change. It is now my pleasure to pass the call over to Harit.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Thank you, Brian. Good afternoon, everyone. Thank you for joining us today. With multiple data readouts from REVEAL one and REMAIN one, key commercial insights in weight maintenance and a regulatory filing in REJUVA001 expected over the course of the next two quarters, twenty twenty five is poised to be a year of acceleration for Fractal. When we went public in early twenty twenty four, we did so with a bold ambition to redefine the treatment of obesity by offering patient friendly solutions for durable improvements in weight and metabolic control.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Since then, GLP-one drugs have accelerated a revolution in obesity care and have proven to be amazing medicines. But real world evidence is beginning to show that there's still room for improvement to meet the needs of patients struggling with obesity today. A recent study published by researchers at the Cleveland Clinic in JAMA suggests that GLP-1s do not deliver nearly as much weight loss in the real world as they did in their clinical trials. Three hundred seventy seven semaglutide treated patients with obesity lost only 5.9% of their body weight at one year, representing only about one third of the body weight loss seen in semaglutide clinical trials, even when accounting for persistent medical coverage. In addition to this efficacy gap, these drugs also have a durability gap.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Today, most patients stop GLP-one treatment in less than one year and only a minority resume GLP-1s in the year after discontinuation. So there's a clear need for nondrug options to drive greater efficacy in the real world and to offer an alternative when patients need to stop medical therapy. At Fractal, we are focused on solving that problem. We are pioneering scalable outpatient solutions aimed at delivering durable metabolic resets for patients, building a new category of care based on existing patient flow into GI endoscopy, and initially targeting the critical need for weight maintenance after discontinuing GLP-one drugs. Regardless of short term market dynamics, by nearly every operational measure, we have made extraordinary advances, positioning Fractal at the forefront of this emerging and substantial clinical and market opportunity.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Today, we are excited to share significant progress on that front. I will start with a major milestone. We have completed full enrollment of the REMAIN one pivotal cohort, which is evaluating Revita for durable weight maintenance after GLP one discontinuation. We filed with the FDA just in March of last year to initiate that study, received an IDE in April, obtained breakthrough device designation in July, initiated enrollment in August, and have now completed enrollment only nine months later and significantly ahead of schedule. This rapid enrollment reflects not only the significant unmet need felt by both patients and physicians for an off ramp for GLP one drugs, but also clearly demonstrates product market fit for Revita in weight maintenance.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Now that the study is fully enrolled and the last patients are initiating tirzepatide therapy, based on our observed time to achieve 15% total body weight loss, we anticipate completing randomization of these three fifteen participants to Revita versus Sham in the first half of twenty twenty six and anticipate reporting pivotal six month primary endpoint data in the second half of twenty twenty six. Remember, we believe only a single pivotal study is required for approval for Ruvita in weight maintenance. Next, the REMAIN one midpoint cohort completed enrollment in Q4 twenty twenty four, and we are confident in our ability to deliver the first blinded, controlled data from these 45 participants with three months of follow-up in Q3 twenty twenty five, a major catalyst that we believe will help validate Revita's potential for these patients in need. Now turning to the REVEAL one cohort. In April, we shared encouraging initial results.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

15 participants who had lost weight on GLP-one drugs, discontinue their GLP-one, underwent Revita, and entered structured diet and lifestyle support. For the participants who had one month follow-up data at that time, average weight regain was just one point two percent compared to the approximately three percent typically seen after GLP one cessation. Two participants with three month follow-up showed persistent weight loss through that follow-up period as well. In June, we expect to present an incremental update with three month data from the REVEAL one cohort, providing what we believe is critical early validation of Revita's potential. When patients stop tirzepatide, one would expect them to regain about 6% body weight by three months.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

So we will compare REVEAL one cohort results to that historical comparator. As you recall, for Rovita, we have built a hub and spoke network across The United States with referring clinics called spokes sending patients to leading GI endoscopists at hub centers from Los Angeles to New Hampshire and Seattle to Miami. Looking ahead to potential approval and commercial launch, this broad and rapid enrollment in the REMAIN one study highlights the efficiency, scalability and throughput of our commercial model. We anticipate that these centers and others like them will form the foundation of our first commercial wave and we are energized by these early indicators of Revita's market potential and the relationships that we've been building with physicians across The United States. As part of our commercial planning, we conducted in-depth market research with patients and other key stakeholders as well.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

And the findings were clear. Patients are highly motivated to find an off ramp to GLP one therapy. The patient living with obesity does not want to stay on chronic pharmacotherapy to manage their condition for the rest of their life. Patients uniformly expressed strong interest in Revita. So what you can see is that we made a lot of progress in a short time with Revita in weight maintenance, and seeing our acceleration into an exciting and important new area of medicine called weight maintenance, where we are breaking ground in a substantial therapeutic category that has emerged because of the success that GLP-1s have with weight loss, but where they fall short with weight maintenance.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Now

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

turning

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

to Rejuva, our pancreatic gene therapy platform that is designed to reprogram the pancreas itself to deliver durable metabolic control from within. We are building what we believe will be the best in class GLP one based therapy for obesity and metabolic disease. Potency, durability, tolerability, and convenience. Rejula is designed to deliver smart, nutrient responsive GLP one expression in the pancreas, enabling natural metabolic regulation without the burden of chronic injections, adherence challenges, or escalating costs. We believe Rejuva sets a new standard for how to leverage the known therapeutic benefits of nutrient stimulates hormones for long term control of metabolic disease.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

It was only in January of last year that we nominated Rejuva one as our first clinical candidate and demonstrated that our one time pancreas targeted smart GLP one gene therapy outperform semaglutide in preclinical models of diabetes and obesity. Importantly, Rejuva doesn't just drive more weight loss, It seems to deliver better quality of weight loss compared to semaglutide. Rejuva preserves lean mass while reducing fat mass addressing one of the major challenges seen with high dose GLP one therapy. By December, we demonstrated the precision of local pancreatic delivery in a large animal model, achieving strong, durable GLP-one expression with a single low dose and no safety signals observed. We also completed key in vivo CTA enabling studies for REJUVA-one by the end of the year.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Momentum continued into the first quarter of twenty twenty five as we achieved regulatory alignment with European authorities on our planned first in human study design. This positions us for an exciting series of milestones ahead. This weekend at ASGCT, we look forward to sharing new exciting data on REJUVA-one safety, efficacy, and potential tolerability based on our preclinical CTA enabling studies. And then in June, we plan to submit our first CTA module to regulators with additional filings following shortly thereafter. Pending regulatory authorization, we expect to dose our first patients with REJUVA one and to report preliminary data in 2026.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

If successful, Rejuva could totally redefine the treatment paradigm for diabetes and obesity, delivering a first in class programmable and durable therapy at scale. Working with a leading CDMO in AAD manufacturing, we've developed a large scale cGMP manufacturing process to support the size of the projected patient population that could be served by our Rejuva platform. We have completed AAV production runs in 500 liter bioreactors, demonstrating a strong foundation for scalable manufacturing with the potential for significant expansion even from where we are now. What this means is that we see a pathway to drive COGs several orders of magnitude lower than current systemic gene therapy products. We believe this could be a huge win for patients and enable a cost structure designed for the broadest possible access to our therapies.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

We believe that for AAV based therapies to succeed, they must be safe, effective, and commercially viable. And this is precisely why we're so excited about the Rejuva platform. With Revita and Rejuva both advancing rapidly, we're entering a catalyst rich period of acceleration and key proof points in the months ahead for Fractal, and we look forward to delivering transformative data within the next several months to you. With that, I'll turn the call over to Lisa for a financial update.

[Lisa Davidson, CFO & Treasurer at Fractyl Health]

Thank you, Harith. In the first quarter of twenty twenty five, we continued to invest strategically in the clinical and operational progress you just heard about. Research and development expense was 19,400,000.0 compared to 14,400,000.0 in the first quarter of twenty twenty four. This increase reflects continued advancement of our REMAIN one study, development of the Rejuva program, and in personnel related expenses. Selling, general, and administrative expense was 5,300,000.0 compared to 7,100,000.0 in the same period last year, primarily due to a reduction in stock based compensation expenses, partially offset by increased costs associated with operating as a public company.

[Lisa Davidson, CFO & Treasurer at Fractyl Health]

We reported a net loss of $23,700,000 compared to a net loss of $3,300,000 in Q1 twenty twenty four. This was largely due to the fluctuation in the non cash change in fair value of notes and warrants and partially driven by increase in operating expenses. As of 03/31/2025, Fractal had approximately $42,100,000 in cash and cash equivalents. Based on the projected cost of our clinical development plans and current enrollment trends, we believe our existing cash and cash equivalents will be sufficient to fund our operations into the fourth quarter of twenty twenty five. This update primarily reflects the accelerated pace of enrollment in our REMAIN one pivotal study, combined with additional investments in REJUVA-one manufacturing scalability.

[Lisa Davidson, CFO & Treasurer at Fractyl Health]

Investments, we believe, are critical to advancing both the Revita and REJUVA platforms toward key value creating milestones. Before I turn it back to Harith, I want to briefly address a topic that's come up in recent investor conversations, the potential impact of tariffs. As a development stage company focused on R and D and clinical studies and regulatory planning, we don't believe current tariff policies could materially affect our business for the foreseeable future. While some of our lab supplies and device components are sourced internationally, any related cost exposure is currently minimal and does not impact our near term financial guidance. We are monitoring policy developments closely and will reassess as we move closer to commercial launch.

[Lisa Davidson, CFO & Treasurer at Fractyl Health]

With that, I'll turn the call back over to Hari.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Thank you, Lisa. Twenty twenty five is shaping up to be a defining year for FRACTAL, one where execution, breakthrough data, and regulatory progress come together to drive meaningful momentum. In the months ahead, we expect to deliver three major catalysts, incremental three month data from the REVEAL one cohort in June, the first CTA module submission for REJUVA one in June, and midpoint randomized data from the REMAIN one midpoint cohort in the third quarter. For the REVEAL one cohort, success means demonstrating stable weight maintenance without GLP-one therapy. For the REMAIN one midpoint cohort, success means showing clear separation between Ruveda and Sham.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

And for REJUVA one, success means earning authorization to initiate first in human studies. Each of these would represent a major validation of our platforms and our leadership position in metabolic care. We are so deeply grateful to the patients, physicians, employees, and investors who are supporting our mission to transform the future of metabolic disease treatment. We look forward to updating you as we execute on our upcoming key milestones. And I'd like to take a moment to recognize Doctor.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Tim Kiefer, our Chief Scientific Officer, for his leadership in advancing REJUVA one on its path to the clinic. As we transition REJUVA into its next chapter of clinical development, Tim will continue to support Fractal as a scientific consultant, and we are grateful for his continued contributions in that regard. Operator, we're now ready to open the call for 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 11 on your telephone and wait for your name to be announced. To withdraw your question, please press 11 again. Our first question comes from the line of Jason Gerberry of Bank of America Securities.

[Operator]

Your line is now open.

[Chi Fong, VP - Equity Research at Bank of America Merrill Lynch]

Hey, this is Chi on for Jason. Thanks for taking our questions. Just a couple from me. Regarding the midpoint analysis of REMAIN one, I understand you guys have reaffirmed the time on 3Q. But just curious if you have already randomized all the forty five patients, meaning that they have already achieved the minimal 15% weight loss with the GLP-one such that I just wanna get a sense of when we might get the midpoint analysis in 3Q?

[Chi Fong, VP - Equity Research at Bank of America Merrill Lynch]

And the second question is, thanks for the color on what you see as a bar of success for the remaining one midpoint analysis, which you frame as clear separation of SAM versus RIVERA. I'm curious, at the twelve week analysis, is there any sort of effect size delta that you're expecting to see between the sham arm and the raviviate arm from the REMAIN one point analysis? Thanks so much.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Thanks, Chi. Look forward to seeing you in Las Vegas at your conference in a couple of days. Like what? Yeah, let me reaffirm on the midpoint. Well over forty five patients have hit 15% total body weight loss, and so we feel like we are confident in our, anticipation of that dataset coming in Q3.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

And then with respect to the twelve week analysis on effect size, our goal in, is to demonstrate that we are at least 50% better than what you would expect to see from tirzepatide withdrawal, and we are sort of reaffirming that expectation as we sit here today. We're excited by what the REVEAL one open label data just next month will show at three months as an early open label view towards that, and then, just a short while later, the ran first randomized data for maintenance therapeutic strategy. Thanks for your question.

[Chi Fong, VP - Equity Research at Bank of America Merrill Lynch]

Great. Look forward to seeing you tomorrow.

[Operator]

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

[Avraham Novick, Biotech Equity Research Associate at Morgan Stanley]

Hey, good afternoon. It's Avi Novak calling for Mike. Thank you for taking our questions and congrats on all the progress. So I guess starting with the upcoming REVEAL one update in June, will the three month data be from all seven subjects who we had data for previously? And is there a possibility that we could see date I guess perhaps earlier data from additional patients who have been enrolled in the study?

[Avraham Novick, Biotech Equity Research Associate at Morgan Stanley]

So that's one. And then I guess on the REMAIN-one midpoint analysis, could you remind us what mechanisms you have in place to limit a placebo effect? Thanks.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Sure, great. So on question number one, the REVEAL one update, we had reported that there were 15 patients who had enrolled as of, the April when we made our last announcement. We expect that the majority of them will have hit their three month follow-up by that time, and we will have incremental one month data to share as well, and we look forward to sharing that in June. With respect to limiting variability and sham effect, this is a super important question particularly in device based procedural therapy studies. We keep a very close eye on all of the different variables that could be impacting the likelihood of sham effect.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

The biggest among those, are patient behavior and adherence to the diet and lifestyle program in the, post procedure period, and one of the things that really helps us in that regard is having the ability to observe patients through their 15% weight loss journey on tirzepatide during that open label run-in phase in order to confirm patient adherence and ability to follow procedures leading into the study. The second big thing that I would focus on is, bear in mind this is the first significant pivotal study for weight maintenance after GLP-one discontinuation, so I think we're leading the field here and defining, how these things can be done. But one thing that differentiates REVEAL from REMAIN is the relative homogeneity of the REMAIN one patient population going into the randomization. And so, as you know, we are selecting patients in REMAIN who are obese, non diabetic, GLP-one drug naive, and we are putting them on tirzepatide so they're all getting the same drug and we're titrating it as per protocol, and then once they hit 15% body weight loss, then we are randomizing them as close to that weight loss as possible. So we expect a tighter window of weight loss achieved at the time of randomization.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

As we know from the GLP one category that gender can affect GLP ones and glycemic status can affect the effect of GLP one. So we'll be looking at all of those things and controlling for all of those things in our randomization, but those are the two big ones that I would focus on that we are clued into and monitoring very closely.

[Avraham Novick, Biotech Equity Research Associate at Morgan Stanley]

Great. Thank you for taking our questions.

[Operator]

Thanks. Thank you. One moment for our next question. And our next question comes from the line of Michael DiFiori of Evercore ISI. Your line is now open.

[Michael Difiore, Managing Director at Evercore]

Hey guys, thanks so much for taking my question and congrats on all the continued progress. A few for me. Just given all of the shakeup at the FDA in CBER and possibly on the device side, are there any concerns or potential red flags that you're seeing now that could undermine or slow down your regulatory submission process? And in terms of Rejuva, it sounds like the boxes are still being checked on the EU regulatory front. Are there any more gating factors in The U.

[Michael Difiore, Managing Director at Evercore]

S. For the CTA? And if so, what are they? And I have one follow-up.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Sure. So with respect to the FDA shakeup, we are not seeing anything on Rubida that could impact our regulatory interactions. We've had ongoing dialogue with the FDA on small matters and everything is proceeding normally. With respect to Rejuva, as you may recall we took in full US First in human strategy. We're planning to file in Europe and in Australia to do the person human study in those geographies, and so we don't feel like we are affected by near term changes at CBER at all.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

With respect to your second question, REJUVA001, well, there's there's really nothing other than preparing all of the documentation necessary in order to file for both the device and for the drug and for the DMT lot release, and we're checking boxes on all of those fronts and submitting, in a systematic way. We'll keep you updated on that in our next updates, per course, but we are on track for our submission coming up in the next several weeks here.

[Michael Difiore, Managing Director at Evercore]

Got it. Excellent. And just my final question is simply, are there any developments for, Rajuda's obesity construct that are, worth mentioning?

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Exciting stuff, but nothing worth mentioning publicly yet.

[Michael Difiore, Managing Director at Evercore]

Got it. Thanks again.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Thank you, Mike.

[Operator]

Thank you. We'll limit for our next question. And our next question comes from the line of Whitney Ijem of Canaccord Genuity. Your line is now open.

[Whitney Ijem, Managing Director at Canaccord Genuity Inc]

Hey, guys. Congrats on all the progress. A few from me. So on REMAINS one, can you quantify or help us understand, I guess, how far ahead enrollment was relative to expectations? And was that driven by more sites getting open than you thought, more demand at the individual sites?

[Whitney Ijem, Managing Director at Canaccord Genuity Inc]

Any color you can give us on that?

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Sure, happy to. Roughly three months ahead of schedule, we saw that enrollment was proceeding more rapidly than we expected over the last couple of months. We had guided to in full enrollment by summer. And in fact, we by sort of within the last several weeks, we had to cap our first sites because the demand to participate at those individual sites exceeded our capacity to be able to satisfy that demand. We thought that that would happen, that demand would sort of trickle after an initial bolus at sites, but actually the demand just continued to develop.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

And so this is excess demand at a site level relative to our expectations. We actually ended up enrolling a smaller number of sites in the study than we had originally thought that we needed.

[Whitney Ijem, Managing Director at Canaccord Genuity Inc]

Got it. That's helpful. Okay. And then can you remind us, in what the sham procedure looks like, what's involved there? And then I guess just a follow-up question on the kind of controlling placebo response question.

[Whitney Ijem, Managing Director at Canaccord Genuity Inc]

You stratifying based on some of the things that you said you're monitoring, are you stratifying patients based on kind of adherence during the 15% weight loss period or percent weight loss at the time of the rumor or any other metrics in that regard?

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

So with respect to the sham procedure, everyone gets an upper endoscopy and everyone gets the catheter introduced into their intestine and then randomization occurs and either there is a dwell time of that catheter within the duodenum in lieu of performing the procedure or the procedure is performed. And then there is a script that physicians and the teams in the room have to follow after the procedure is complete in order to not unblind the patients. Then the physicians who manage those patients, are not the ones who are in the room and so the whole study team that is blinded does not know what happened within that room There's a Chinese wall set up, that separates those two. So that's the way in which the sham is protected. We feel like it's about as rigorous as you could possibly imagine a sham being, and, we're proud of the rigor of that scientific evidence.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

And then the question that you asked me about randomization, you know, do have certain factors that are that we are stratifying on for randomization. It's only 45 subjects in the the remain one open label in the midpoint cohort, and so can't be stratifying on too many things. But the big ones are baseline BMI and gender are two top things that really will impact that have the impact ability to impact weight regain, and so those are ones that we focused on and how we thought about stratifying randomization.

[Whitney Ijem, Managing Director at Canaccord Genuity Inc]

Got it. Okay. And then just one on Rejuva. Assuming all goes well with the CTA, how should we think about timelines to get the study up and running and patients dosed thereafter? Thinking in particular about the training process for the administration procedure and how long will that take?

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Well, we've guided to dosing the first patients and preliminary data in 2026 and we continue to feel very confident in that guidance. There's nothing more to be said about that right now, but of course over the next several quarters we will continue to give you more specifics on that. I'm excited that you asked me a question about the training process. The Rejuva procedure we just came out of the DDW meeting which is a GI meeting that's conducted annually was in San Diego. We had a clinical advisory board meeting there with several GI endoscopy experts.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

They love the Rejuva catheter that we have designed and they believe that the procedure that we are asking them to conduct is right down the middle of the fairway of things that they already know how to do. That we will be super rigorous about how we train them like we are with Rubida, but we anticipate that this will be a very straightforward, although a very momentous first human case when we deliver gene therapy to the pancreas for the first time, the complexity will not be in delivering the needle into the pancreas. That is something they do all the time and are super comfortable with.

[Whitney Ijem, Managing Director at Canaccord Genuity Inc]

Perfect. That's really helpful. Thanks so much.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Thanks.

[Operator]

Thank you. I'll now turn the call back to Doctor. Rajan Gopalam for closing remarks.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Well, thank you very much, everyone. Thanks for joining us. As always we appreciate your continued interest and support of Fractal. Let's just end with how we started, there's an efficacy gap and a durability gap in obesity care today and we are laser focused on trying to close those gaps. And we look forward to sharing our updates on our progress with Revita and Rejuva.

[Harith Rajagopalan, Co-Founder, CEO & Director at Fractyl Health]

Thanks so much.

[Operator]

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

Participants

Executives

• Brian Luque, Head - IR & Corporate Development
• Harith Rajagopalan, Co-Founder, CEO & Director
• Lisa Davidson, CFO & Treasurer

Analysts

• Chi Fong, VP - Equity Research at Bank of America Merrill Lynch
• Avraham Novick, Biotech Equity Research Associate at Morgan Stanley
• Michael Difiore, Managing Director at Evercore
• Whitney Ijem, Managing Director at Canaccord Genuity Inc