Earnings call transcript: Fractyl Health’s Q1 2025 shows rising R&D costs

Fractyl Health Inc. (GUTS) reported its Q1 2025 earnings, revealing a significant increase in research and development expenses alongside a widened net loss. The company’s stock reacted negatively in aftermarket trading, dropping 4.52% to $1.69. According to InvestingPro data, the company has seen a significant -71.97% decline over the past year, though recent momentum shows a 14% gain in the last week. Despite this, Fractyl Health remains optimistic about its innovative platforms and future growth.

Key Takeaways

• Fractyl Health’s R&D expenses surged to $19.4 million, up from $14.4 million in Q1 2024.
• The company reported a net loss of $23.7 million, significantly higher than the $3.3 million loss in the previous year.
• Aftermarket trading saw the stock price fall by 4.52%.
• Cash reserves are strong, with $42.1 million on hand, providing a runway into Q4 2025.
• Upcoming catalysts include pivotal data releases and regulatory submissions.

Company Performance

Fractyl Health’s Q1 2025 results highlighted a focused investment in research and development, with expenses increasing to $19.4 million. This strategic allocation is part of the company’s long-term vision to pioneer scalable outpatient solutions for metabolic resets. However, the widened net loss of $23.7 million compared to last year’s $3.3 million reflects the financial strain of these investments. The company’s cash position remains robust, ensuring operational stability into late 2025.

Financial Highlights

• R&D Expenses: $19.4 million, up from $14.4 million in Q1 2024
• SG&A Expenses: $5.3 million, down from $7.1 million in Q1 2024
• Net Loss: $23.7 million, compared to $3.3 million in Q1 2024
• Cash and Cash Equivalents: $42.1 million

Market Reaction

Following the earnings release, Fractyl Health’s stock fell by 4.52% in aftermarket trading, a reflection of investor concerns over the increased net loss and ongoing R&D expenditures. The stock, which closed at $1.71, saw a decline to $1.69, marking a notable movement within its 52-week range of $0.87 to $7.89.

Outlook & Guidance

Fractyl Health’s future outlook is centered around its Revita and Rejuva platforms. Key upcoming catalysts include the release of REVEAL one three-month data and the submission of the first REJUVA one CTA module in June. The company is also preparing for pivotal data releases and regulatory submissions in the latter half of 2025. InvestingPro data shows the company maintains a healthy current ratio of 3.63, indicating strong short-term liquidity, though it operates with a moderate debt-to-equity ratio of 2.2.

Executive Commentary

Dr. Harith Rajagopalan, CEO of Fractyl Health, emphasized, "Twenty twenty-five is shaping up to be a defining year for Fractyl," highlighting the company’s commitment to innovation. He added, "We are pioneering scalable outpatient solutions aimed at delivering durable metabolic resets," underscoring the strategic focus on metabolic health solutions.

Risks and Challenges

• Increased R&D expenditures may strain financial resources if not managed effectively.
• Market competition in metabolic health solutions could impact Fractyl’s market share.
• Regulatory hurdles and delays in product approvals could affect timelines.
• Economic uncertainties may influence investor confidence and funding opportunities.

Fractyl Health’s Q1 2025 earnings demonstrate a strategic emphasis on innovation and development, setting the stage for potential breakthroughs in metabolic health solutions. However, the financial implications of these investments and the associated market reaction highlight the challenges ahead. InvestingPro subscribers have access to 12 additional ProTips and comprehensive financial metrics that provide deeper insights into Fractyl Health’s investment potential.

Full transcript - Fractyl Health Inc (GUTS) Q1 2025:

Conference Call 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.

Brian, you may now begin.

Brian Lucay, Head of Investor Relations and Corporate Development, Fractal 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.

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.

Dr. Harith Rajagopalan, Chief Executive Officer, Fractal 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.

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.

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.

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.

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.

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.

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.

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.

Now

Brian Lucay, Head of Investor Relations and Corporate Development, Fractal Health: turning

Dr. Harith Rajagopalan, Chief Executive Officer, Fractal 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.

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.

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.

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.

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, Chief Financial Officer, Fractal 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.

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.

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.

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

Dr. Harith Rajagopalan, Chief Executive Officer, Fractal 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.

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.

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.

Conference Call 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.

Your line is now open.

Chi, Analyst, Bank of America Securities: 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?

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.

Dr. Harith Rajagopalan, Chief Executive Officer, Fractal 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.

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, Analyst, Bank of America Securities: Great. Look forward to seeing you tomorrow.

Conference Call 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.

Avi Novak, Analyst, 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?

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.

Dr. Harith Rajagopalan, Chief Executive Officer, Fractal 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.

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.

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.

Avi Novak, Analyst, Morgan Stanley: Great. Thank you for taking our questions.

Conference Call 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 DiFiori, Analyst, Evercore ISI: 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.

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

Dr. Harith Rajagopalan, Chief Executive Officer, Fractal 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.

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 DiFiori, Analyst, Evercore ISI: Got it. Excellent. And just my final question is simply, are there any developments for, Rajuda’s obesity construct that are, worth mentioning?

Dr. Harith Rajagopalan, Chief Executive Officer, Fractal Health: Exciting stuff, but nothing worth mentioning publicly yet.

Michael DiFiori, Analyst, Evercore ISI: Got it. Thanks again.

Dr. Harith Rajagopalan, Chief Executive Officer, Fractal Health: Thank you, Mike.

Conference Call 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, Analyst, Canaccord Genuity: 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?

Any color you can give us on that?

Dr. Harith Rajagopalan, Chief Executive Officer, Fractal 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.

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, Analyst, Canaccord Genuity: 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.

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?

Dr. Harith Rajagopalan, Chief Executive Officer, Fractal 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.

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, Analyst, Canaccord Genuity: 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?

Dr. Harith Rajagopalan, Chief Executive Officer, Fractal 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.

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, Analyst, Canaccord Genuity: Perfect. That’s really helpful. Thanks so much.

Chi, Analyst, Bank of America Securities: Thanks.

Conference Call Operator: Thank you. I’ll now turn the call back to Doctor. Rajan Gopalam for closing remarks.

Dr. Harith Rajagopalan, Chief Executive Officer, Fractal 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.

Thanks so much.

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

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