Fractyl Health, Inc. Q1 FY2024 Earnings Call

Good afternoon, and welcome to Fractyl Health's First Quarter Financial Results and Business Updates Call. As a reminder, this conference call is being recorded. At this time, all participants are in a listen-only mode. There will be a Q&A session following management's prepared remarks. I will now turn the call over to Stephen Jasper. Stephen, you may now begin.

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. Today on our call, Dr. Harith Rajagopalan, Chief Executive Officer; Lisa Davidson, Chief Financial Officer; Dr. Timothy Kieffer, Chief Scientific Officer and Adrian Kimber, Chief Commercial Officer will review our recent business highlights and first quarter financial results. Before we begin, I would like to remind everyone that statements made during this conference call that do not relate to matters of historical fact, including statements about our objectives and anticipated clinical milestones, preclinical or clinical trial data, the impact of any of our product candidates, the design, initiation, timing and results of clinical enrollment and any clinical trial or readouts, the potential launch or commercialization of any of our product candidates or products and the sufficiency of our cash, cash equivalents and investments to fund our operating activities for any specific period of time should be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are intended to be subject to the Safe Harbor protection provided by the Reform Act. Actual results could differ materially from those indicated by the forward-looking statements due to the impact of risks, uncertainties and other important factors. Participants are directed to the risk factors set forth in Fractyl's quarterly report on Form 10-Q for the period ended March 31, 2024 and the company's other filings with the Securities and Exchange Commission. Any forward-looking statements made today speak only to Fractyl's operations as of today. Fractyl disclaims any duty to provide updates to its forward-looking statements even if subsequent events cause the company's views to change. It is now my pleasure to pass the call over to Harith.

Thank you, Stephen and good afternoon everyone. Thank you for joining us for our first quarterly results call. Over 10 years ago, I co-founded Fractyl with a singular and audacious goal to eradicate metabolic disease. As a physician, I saw firsthand how Type 2 diabetes and obesity and their comorbidities impact patients and their families. I witnessed patients experience complications of disease despite following all of their doctors' advice, spouses becoming caregivers and children losing parents far too young to diseases that should be entirely treatable. I knew that there had to be a better way to address these issues by tackling the diseases at their root cause in the gut and in the pancreas, and thus, Fractyl Health was born. We have always been clear with our vision to develop transformative therapies that can prevent and eliminate metabolic disease. We have never wavered in our focus because we knew that treating the underlying disease is the most patient-centered approach to better long-term health. I'm pleased to be here today to present these results because we are so close to achieving the goals we set forth for ourselves a decade ago. 2024 is shaping up to be a pivotal year for Fractyl. We are executing on our strategy, we are clear about the future and we are ready to bring Fractyl to the next level to help even more patients around the world. The treatment landscape for metabolic disease has radically changed over these last several years with the emergence of GLP-1 drugs. These therapies are incredibly effective and exciting developments, but they also have significant limitations. Their need for chronic administration, their high discontinuation rates, and the dramatic weight regain and loss of metabolic benefits observed as soon as people stop treatment. To address this unmet need, we are developing transformative therapies that precisely target and alter the function of the diseased organs that are responsible for the development of obesity and Type 2 diabetes. In a world with potent drugs that still do not eliminate disease, we believe the clinical and economic value proposition is shifting now from chronic disease management to the prevention and remission of underlying disease. Our two platforms, Revita and Rejuva target dysfunction in the duodenum and pancreas respectively and are designed to provide long-term metabolic benefits from a single administration. Our Revita platform is a proprietary device and delivery system that targets the duodenum to reverse the pathology in the duodenal lining that is a root cause of obesity and Type 2 diabetes. Revita uses heat energy to ablate dysfunctional duodenal mucosa to enable the regeneration and renewal of the duodenum and restore normal metabolic signaling from the gut. The procedure takes less than 45 minutes and patients can immediately return to their daily lives. We have received breakthrough device designation from the FDA for Revita and have evaluated it in over 300 patients across multiple clinical studies and have observed over 500 patient years of exposure data demonstrating favorable tolerability as well as favorable and durable impact on blood sugar and body weight. Focusing on obesity, despite the popularity of GLP-1 drugs, approximately half of the people who start taking them stop them within one year for a variety of reasons. We believe that what the world needs now is a safe, reliable, and effective off-ramp from GLP-1s, an off-ramp that allows weight loss to persist even as people stop taking these medicines. This is where the unmet need in obesity has shifted from how do you lose weight to how do you keep it off. A Wall Street Journal feature article last week pointed to weight regain as the major problem in obesity management today, and it featured a patient who underwent the Revita procedure approximately one year ago in Germany and who still has durable improvements in body weight and blood sugar today. We, as a company, have always been focused on durable metabolic benefits and we believe that we are uniquely well-positioned to become leaders in addressing this need in obesity management today. At the end of March, we received IDE approval from the FDA for Revita's Remain-1 study in patients with obesity who wish to maintain weight loss after discontinuing GLP-1 treatment. The approval from the FDA to begin this pivotal study came earlier than we had expected and we are excited about our rapid alignment on this pivotal IDE. We believe it is a result of the growing recognition of obesity as a disease and the heightened urgency that has emerged for therapeutic alternatives that do not depend upon lifelong pharmacotherapy. We expect to initiate the study in the second half of the year. We firmly believe that freedom from disease is the ultimate aspiration for people and patients. If successful, the Remain-1 study would allow Revita to offer millions of people the potential for durable weight loss maintenance without the burden of ongoing medical therapy. We are also currently evaluating Revita in our Revitalize-1 pivotal trial in patients with inadequately controlled Type 2 diabetes. We expect to complete enrollment in the second quarter and share top-line data in the fourth quarter of this year. In Europe, Revita has a CE Mark and has secured reimbursement authorization in Germany. We have initiated a commercial pilot launch to conduct a real-world registry study in Germany as we complete our pivotal trials in the United States. We anticipate that registry data combined with U.S. pivotal data will be valuable tools to demonstrate the potential impact of Revita to patients and payers. This morning, we shared data from this real-world study at the German Diabetes Association Annual Meeting, and we found that Revita demonstrated substantial and sustained improvements in blood sugar and body weight through six months of follow-up so far in patients who have enrolled in the German registry. What is particularly exciting about this registry experience is the report from patients themselves. The sense that Revita has offered them a new lease on life and a new hope to live a life that is not defined by their disease. Tim will tell you more about those new data and our clinical development progress, and then Adrian will provide perspective on Revita's commercial opportunity in just a few moments. Now turning to our Rejuva platform, Rejuva is our locally administered AAV delivered pancreatic gene therapy platform delivering metabolic hormones, including GLP-1 and is designed to enable long-term remission of Type 2 diabetes and obesity by durably altering hormone function in the pancreas. At the beginning of this year, we nominated our first Rejuva candidate for Type 2 diabetes, RJVA-001, a one-time locally administered AAV9 viral vector that expresses GLP-1 hormone with an insulin promoter that is designed to durably improve pancreatic function in Type 2 diabetes. We expect to initiate our first-in-human trials in Type 2 diabetes in the first half of 2025. We are also working to nominate our first candidate for a one-time treatment for obesity, which we are planning to announce in the back half of 2024. With that, I'll now turn the call over to Tim to provide additional color on the progress we are making across both our Revita and Rejuva platforms.

Thank you, Harith. Prior to joining Fractyl Health as CSO, I was a professor in the faculty of medicine at the University British Columbia and CSO at Biocyte. Given my training in gastrointestinal hormones and islet biology, I'm a passionate believer in Fractyl's therapeutic approaches targeting the gut and pancreas, the key metabolic organs where dysfunction is a root cause of diabetes and obesity. I'll begin with a review of Revita platform progress and then turn to Rejuva. As previously mentioned, we recently provided an update from our ongoing real-world German registry study of Revita in patients with Type 2 diabetes after the German Diabetes Association Annual Meeting. In 14 participants where we have six months of post-Revita follow-up, there was an average body weight loss of 8.1% that was generally sustained through six months thus far and a fall from median baseline blood glucose levels of 153 mg/dL to 116 mg/dL, accompanied by a hemoglobin A1C dropping from 9.2 to 7.6. These are particularly exciting findings given these are patients with advanced Type 2 diabetes who have been unable to control their diabetes through the use of multiple medications or lifestyle changes. We plan to continue enrolling patients in this registry and to provide updates on an ongoing basis. In March, we received IDE approval to initiate Remain-1, a two-part parallel cohort study for weight maintenance in patients with obesity who have lost at least 15% total body weight on GLP therapy and wish to discontinue GLP-1 without weight regain. Alongside, we will have our Reveal-1 open label cohort of patients who will be managed in exactly the same way, and we expect to begin providing open label study updates in the second half of the year. With the Remain-1 study, we hope to evaluate how Revita can enable patients to maintain clinically meaningful weight loss durably after discontinuing from a GLP-1. We plan to evaluate 315 patients with a BMI of 30 or higher without diabetes who are GLP-1 drug naive. We will have an initial run-in period where patients are placed on a GLP-1 to achieve at least 15% total body weight loss, at which point they will then discontinue the GLP-1 and be double blinded and randomized 2:1 to either receive the Revita procedure or sham treatment, and we will evaluate weight regain at 24 and 48 weeks. We also plan to look at whether cardiovascular risk or glucose levels rebound after discontinuation of the GLP-1 therapy. We expect this trial to enroll quickly as it appeals to three distinct groups of patients. First, those who are currently on a GLP-1 and losing weight, but wish to discontinue due to side effects. Second, those who are currently on a GLP-1 and losing weight and aren't experiencing side effects, but are looking for an off-ramp so they don't have to stay on chronic medication. And third, patients who don't even want to begin GLP-1 therapy due to the chronic regimen. Now in March 2021, we commenced our Revitalize-1 randomized double-blind crossover sham-controlled multicenter pivotal study in patients with inadequately controlled Type 2 diabetes despite being on up to three glucose lowering agents and daily insulin. The study will evaluate the change from baseline in hemoglobin A1C at 24 weeks in approximately 320 patients with additional follow-up through 48 weeks. We anticipate completing enrollment in the first half of this year and will report top-line results in the fourth quarter. We have discussed this study design with the FDA and believe that successful data may support PMA for Revita to improve glycemic control in patients with Type 2 diabetes who are inadequately controlled on insulin. Now moving on to Rejuva. We have evaluated potential GLP-1 pancreatic gene therapy candidates in large and small animal studies. In a head-to-head preclinical diet-induced obesity mouse model, we have observed our GLP-1 pancreatic gene therapy candidates to produce greater improvements in weight loss compared to Semaglutide, durable improvements in weight loss compared to Vehicle control, and the potential weight maintenance solution to prevent weight regain after Semaglutide discontinuation. We plan to complete IND enabling studies or its equivalent for RJVA-001 in the second half of 2024 and pending approval initiate a first-in-human study in the first half of 2025. In addition, we plan to continue working towards nominating our first GLP-1 pancreatic gene therapy candidate for obesity. With that, I will now turn the call over to Adrian to give you an update on our commercial opportunity.

Thank you, Tim, and good afternoon everyone. Since joining the Fractyl team a few months ago, I've been consistently impressed by our people, our science, and our technology. My short tenure here has only strengthened my initial belief that Revita represents a significant opportunity both clinically and commercially. It's evident that there's a significant issue with weight maintenance within our society. In recent times, GLP-1 therapies have been widely prescribed by physicians and adopted by patients to tackle this very issue. However, despite the widespread good coverage by insurance and the observed benefits of weight loss and glucose reduction, over 50% of patients discontinued GLP-1 therapy within the first year. When examining obesity, it's staggering to note that nearly 100 million individuals in the United States suffer from obesity and prediabetes, while globally this number surpasses 800 million. Now turning to Type 2 diabetes, there are over 500 million adults grappling with this condition worldwide. Within the United States alone, 27 million individuals are on medication for Type 2 diabetes with over 4 million relying on insulin therapy for advanced Type 2 diabetes. In 2022, approximately $65 billion was allocated to drugs targeting glucose control and weight management. Notably, all of these expenses were tied to medications necessitating chronic administration yet non-effectively address the underlying disease progression. We perceive this as an immense opportunity and firmly believe that Revita holds a distinctive position to capitalize on this by tackling disease progression and prevention. For individuals currently managing Type 2 diabetes with medications and insulin, Revita aims to enhance glucose control and halt or slow down the disease's advancement. Moreover, for those with prediabetes and obesity, Revita is engineered to target the metabolic dysfunction at its source, mitigating the risk of individuals progressing to Type 2 diabetes and obesity. Revita is a modular system, seamlessly integrated into endoscopist workflow, typically requiring fewer than four cases for the endoscopist to achieve proficiency. It is tailored as an outpatient procedure manageable by trained therapeutic endoscopists in under an hour. In the United States alone, nearly 20 million endoscopies are conducted annually with over 600,000 categorized as advanced endoscopic procedures carried out by almost 10,000 gastroenterologists. The Revita procedure is specifically designed as a straightforward addition to the 4.7 million endoscopies already administered annually to patients with Type 2 diabetes. As Harith mentioned, Revita has a CE mark in Europe and we initiated a limited commercial pilot program at a single site in Germany last year to gather real-world data as we complete our U.S. pivotal studies. As we progress our Revita clinical program, we plan to build out a U.S.-based direct sales force and commercial organization to support our U.S. launch ahead of Revita's potential FDA approval. Our commercialization strategy involves implementing a hub-and-spoke approach to establish Revita as an innovative procedural therapy for addressing obesity and Type 2 diabetes. And initially, we'll concentrate on centers of excellence housing advanced therapeutic endoscopists with a primary focus on engaging participating physicians from our clinical studies. Furthermore, we'll introduce a comprehensive procedural training support program tailored for GI and endoscopists, ensuring Revita seamlessly integrates into their workflow. With that, I will now pass the call on to Lisa to give an update on our first quarter financials.

Thank you, Adrian. In the first quarter of 2024, revenue was generated from our commercial pilot in Germany, which launched in the first half of 2023. Turning to operating expenses. Research and development expense in the first quarter of 2024 was $14.4 million compared to $9.3 million for the same period in 2023. The increase during the quarter was primarily due to increased investment in the Revitalize-1 clinical study, advancement of the Rejuva program and increased personnel-related expenses, including stock-based compensation. Selling, general and administrative expense in the first quarter of 2024 was $7.1 million compared to $2.8 million in the same period in 2023. The increase was primarily due to increased personnel-related expenses, including stock-based compensation and professional services expenses and other costs associated with operating as a publicly traded company. For the first quarter of 2024, we reported a net loss of $3.3 million compared to a net loss of $11.9 million for the same period in 2023. The decrease in net loss was primarily related to a $17.1 million non-cash decrease in fair value of the notes payable and warrants on our balance sheet, $0.7 million in increase in interest income earned offset by an increase of the $9.4 million in operating expenses. As of March 31, 2024, we had cash and cash equivalents of $121.4 million. Based on our current development plans, we believe cash and cash equivalents will be sufficient to fund our operations through expected key company milestones through 2025. I will now turn the call back to Harith.

Thank you, Lisa. Fractyl is at a critical point in our growth trajectory. As you heard from Tim, our two platforms, Revita and Rejuva have the potential to help us realize our vision of creating durable disease-modifying therapies that target the organ level root causes of obesity and Type 2 diabetes with key catalysts coming in the next several quarters across both of our programs in both disease categories. And as Adrian told you, there is significant unmet need in this market for this type of therapy. Fractyl is a different company with a different approach, which we believe meets the needs that are identified by the obesity and Type 2 diabetes patient communities for better health with less medicine. For the remainder of 2024, we are focused on executing on our clinical studies in Type 2 diabetes and obesity, formulating our commercialization plans to introduce Revita to the U.S. and European markets, advancing RJVA-001 through IND enabling studies and efficiently allocating our capital to ensure that we have the runway that we need to meet all of our objectives. It is an incredibly exciting time at Fractyl, and I would like to take a moment to thank the patients and the physicians who have supported us over the past 10 years. We deeply appreciate your trust in us and in our mission. I would also like to acknowledge the hard work and dedication of my fellow Fractylians. They spend a tremendous amount of time and energy focused on helping us achieve our mission and vision, and we truly appreciate their efforts to build something great together. And finally, I'd like to thank you for your continued interest and your support of Fractyl. We look forward to sharing updates on our progress as we work toward bending the curve of metabolic disease globally. And with that, we will now open the call up to questions. Thank you very much.

Thank you. Our first question comes from Jason Gerberry of Bank of America.

Hey, this is Chi on for Jason. Thanks for taking our questions. I have two questions on the Real World Registry study and one on Rejuva. So curious on the Real World Registry study, can you talk about how similar the patient enrolled in the study relative to those enrolled in Revitalize-1? What proportion of the patients were on insulin for the Registry study? Curious if the data from the Real World Registry study can be extrapolated to Revitalize study in some way? Second question on the same study is you provide three month and six month follow-up data from the same study. I'm curious if you can talk about durability of the data with respect to HbA1c reduction as well as weight loss. Are those data in line with your expectation? And do you expect the durability to translate into Revitalize-1 and Reveal-1 respectively? And my lastly on Rejuva, you talk about you look to nominate your first gene therapy candidate for obesity. I'm curious what attributes are looking for the obesity candidate. How might that be similar or different than RJVA-001 that you have selected for diabetes? Thank you.

Thanks, Chi. I look forward to seeing you later this week at the BAML conference in Vegas. We're heading out tomorrow. I'm not sure if you're there yet.

We are there. Jason is traveling in, but we look forward to hosting you.

We're excited about attending the investor conference in Vegas for the first time, and I appreciate your questions. Let's discuss the Real World Registry first. I'll handle the questions and then see if Tim has anything to add. Your first question was about the patient population in comparison to Revitalize-1. I can confirm that it is a similar population, but with a larger group of individuals. In Europe, our CE Mark includes patients with inadequately controlled Type 2 diabetes who are failing at least one glucose-lowering agent, allowing us the opportunity to treat a diverse range of medical therapies. Approximately 20% of Type 2 diabetes patients are on insulin, slightly more than those in the Revitalize-1 study, although I don't have the exact number. Interestingly, we initially thought people with more advanced disease would be more inclined to consider Revita, but we've found that interest is widespread. Individuals on one or two medications show just as much interest in Revita as those on multiple therapies. Surprisingly, many patients are eager to pursue options that target underlying causes, even before reaching the more advanced therapies recommended in the guidelines. This insight is significant for the market and highlights the potential trajectory of Revita in Type 2 diabetes as it evolves. You also inquired about how this might relate to the Revitalize-1 patient results. Historically, we've observed that the hemoglobin A1c reduction, which is the main endpoint in Revitalize-1, corresponds with patients' baseline levels and doesn't seem to hinge on their existing medical treatments. Therefore, I believe this offers complementary evidence to Revitalize-1. We are optimistic about sharing data from both the registry and Revitalize-1 with physicians, patients, and payers as we approach a global launch in a couple of years. Your next question regarding the Real World Registry was about the follow-up at three and six months. Yes, we've provided that data. We see sustained improvements in blood sugar and weight within one month, with continued improvements at three and six months. As we've mentioned previously, we will keep updating the registry data as it grows, and you can expect further updates in Q3 and Q4 this year. Regarding whether these results will translate successfully, I believe it's reasonable to expect that HbA1c and weight results from the registry will align well. Type 2 diabetes in Germany shares many characteristics with that in the United States. One aspect we are particularly keen to explore is the durability of the Revita treatment. Will repeat treatments be necessary? How frequently will they be required? We're excited about the registry helping us answer these questions as we gather more data from patients over the long term. Now, moving on to your third question about the Rejuva obesity candidate and its similarities and differences with Type 2 diabetes. Previously, we noted that the RJVA-001 candidate for Type 2 diabetes features the human insulin promoter driving the human GLP-1 sequence. The human GLP-1 peptide has a brief half-life in circulation and acts locally within the pancreatic islet. This presents an opportunity for a Type 2 diabetes candidate with high local activity and limited systemic bioavailability to improve blood sugar levels. We're enthusiastic about data we released earlier this year indicating that a short half-life GLP-1 candidate can significantly lower blood sugar in the db/db mouse model, which has guided our Type 2 diabetes candidate development. For obesity, we expect to achieve serum levels higher than what's required for the diabetes candidate. Thus, we are planning to nominate a candidate optimized for weight loss in RJVA-002. We are also looking to leverage the platform's capabilities and insights gained from Rejuva-1. We plan to deliver it in a similar manner, utilizing the same viral vectors and plasmid backbones, while the transgene sequences may offer more flexibility. We're particularly interested in exploring multiple concurrent metabolic impacts, such as combining GIP and GLP-1 agonism or other combinations, to achieve distinct therapeutic effects regarding efficacy and safety profiles. There will be substantial opportunities for exploration as this program advances.

Great. Thanks so much.

Thank you. Our next question comes from the line of Mike DiFiore of Evercore.

Hi, guys. This is Mike DiFiore in for Umer. Thanks for taking my question and congrats on all the progress. A few from me, one is on the Remain-1 trial. The question is, how will you ensure compliance post procedure in terms of having patients stick to a uniform reduced calorie diet throughout the entire trial? And how will the stat plan handle dropouts? And I have a follow-up.

Okay, great question. The Remain-1 trial is our pivotal study that received IDE approval at the beginning of April for weight maintenance. Our plan is to enroll individuals who are obese and not Type 2 diabetic, who have not previously used GLP-1 drugs, and start them on tirzepatide therapy, which is the active ingredient in Zepbound, the obesity treatment. We will gradually increase their dosage over several weeks to reach the highest tolerated level and aim for a 15% reduction in body weight. After achieving that, we will stop the tirzepatide and randomize participants to receive either Revita treatment or a placebo, while all participants will receive dietary recommendations similar to those used in other studies of GLP-1 drugs for weight reduction. The goal is to provide nutritional advice consistent with what has been previously studied for similar patient populations. We will also monitor their compliance with dietary guidelines during the initial open-label phase, and we believe that maintaining adherence during these months will translate into continued compliance during the follow-up period. Regarding your question about dropouts, we anticipate that if our therapy is as effective as we project, individuals in the control group may be more likely to withdraw than those receiving treatment. Therefore, we've decided to set a primary endpoint at 24 weeks instead of 48 weeks, and we're looking into whether we can offer Revita to patients who didn’t receive treatment as a crossover option to encourage them to remain in the study. Additionally, there have been studies on GLP-1 withdrawal that have effectively kept patients in follow-up for a year, and we are optimistic about that background. Do you have any more questions, Mike?

Yes. But before I move on, just to clarify what you said about the Remain study. Will the dropouts be centered altogether or will it be like a last observation carried forward type of analysis for the dropout?

Good question. We have an idea of what that should be, but we haven't discussed it with the FDA yet, so it’s too early to provide a definitive answer. I can say that last observation carried forward is no longer the favored statistical method, and there are imputation techniques that are generally preferred in this context. However, the exact approach will need to be discussed with the FDA, and we are not ready to have that conversation yet.

Got it. I have a simple question about RJVA-001. You switched to the fully humanized GLP-1 promoter compared to last year when you were using the GLP-1 analog in your prototype. In the prototype, the beta cell transduction percentage was around 30%. I'm curious to know if the transduction percentage with this humanized GLP-1 promoter is similar or if it differs in any way.

Great question. The transgene sequence may vary, but the AAV9 that delivers it remains consistent. We have observed transduction levels that are quite similar between the candidate and the surrogates we used previously. As part of our dose bridging strategy in preparation for human trials, we need to demonstrate all of this with the candidate in preclinical models. As we progress, we will share the data with you to explain our approach to dose bridging when we transition to clinical trials.

Okay. Very helpful. Thanks so much.

Thanks, Mike. Appreciate it.

Thank you. Our next question comes from the line of Mike Ulz of Morgan Stanley.

Good afternoon. Thanks for taking the question. Maybe just to follow-up on the Remain-1 study, looks like you guys are on track to start that fairly soon. Just curious if there's any remaining steps there to getting that study going? And then maybe secondly, you mentioned sort of providing some early looks at that data set as it starts to move forward? Just thoughts on potential timing there and maybe some types of data that might be shared in the sort of interim updates? Thanks.

Yes, thanks, Mike. We're really excited about the Remain-1 study. With our IDE approval, we've been able to engage with investigators and sites, and the feedback has been very positive regarding the trial and its appeal to patients. We're focused on the necessary steps like site selection and IRB approval. Fortunately, we can utilize our existing clinical trial sites from Revitalize-1, where we have built strong relationships with physicians to expedite the Remain study. Regarding data updates, we will have an open-label cohort called Reveal-1, where patients can be treated similarly to those in Remain, with one exception: we will allow patients who are on or have previously used a GLP-1 drug to join to assess if they can maintain weight loss without continuing the medication. Recently, a tracking poll by the Kaiser Family Foundation revealed that nearly 50% of GLP-1 users are concerned about the ongoing costs, which may drive them to seek alternatives. Additionally, the FDA is focused on patients who experience weight loss benefits but struggle with tolerability issues related to GLP-1s. This means the Reveal-1 cohort will help us evaluate these patients, as well as drug-naive individuals treated like those in Remain. Our plan is to provide study updates beginning in the fourth quarter. We expect to gather early efficacy data from the cohort currently on GLP-1, as they won't require titration. It will take longer for updates from the Reveal-1 cohort, but we believe this information will give us insights into how the Remain-1 study may unfold and what could drive patients to choose Revita. As the year continues, we'll keep you updated on our findings from Reveal and the data timeline.

Got it. That's helpful. Thank you.

Thank you. I would now like to turn the conference back to Dr. Rajagopalan for closing remarks. Sir?

Thank you very much. I appreciate all of your time and attention this afternoon. As I hope you can see, we're firing on all cylinders here, working on Revita for both Type 2 diabetes and for weight maintenance, Rejuva heading towards the first-in-human. What we are excited about is if you fast forward over the period of say one year from now, what types of conversations might we be having, if we have Revitalize-1 data from our Type 2 diabetes program in Revita, and if we have some open-label data on weight maintenance after GLP-1 discontinuation from Reveal and IND enablement heading to a first-in-human for Rejuva, we could be having a conversation that is vastly different than the one we are having now about what the future of Type 2 diabetes and obesity might look like with disease modifying options on the horizon. We're excited about what that could mean for patients first and foremost, and we are motivated by the desire to accelerate that path to that future as rapidly as we possibly can. So appreciate everyone's attention today and look forward to following up.

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