Q4 2024 Fractyl Health Inc Earnings Call & Business Update
Good afternoon, and welcome to Frac Doe helps fourth quarter and full year 'twenty 'twenty four financial results and business update call.
As a reminder, this conference call is being recorded.
This time, all participants are in a listen only mode.
There will be a question and answer session following managements prepared remarks.
I will now turn the call over to Brian Bouquet.
Brian Bouquet: Head of Investor Relations and corporate development at Frac dual Brian you May now begin.
Brian Bouquet: Thank you. This afternoon, we issued a press release that outlines the topics we plan to discuss today.
Brian Bouquet: This release is available at Www Dot <unk> dot com under the investors tab.
Speaker Change: Joining us on the call today are doctor for REIT radical Polly Chief Executive Officer, and Mr. Davidson Chief Financial Officer.
Speaker Change: During this call we make forward looking statements, which involve risks and uncertainties that may cause actual results to differ materially from our forward looking statements.
Speaker Change: We provide a comprehensive list of risk factors in our SEC filings, including the annual report on Form 10-K filed today, which I encourage you to review any forward looking statements on the call are subject to substantial risks and uncertainties and speak only as of the original date and we undertake no obligation to update or revise.
Speaker Change: 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 Harry.
Harry: Thank you, Brian and good afternoon, everyone. Thank you for joining us today.
Speaker Change: <unk>, one drugs have undoubtedly transformed people's ability to achieve short term weight loss.
Speaker Change: However, real world data revealed a significant unmet need in obesity that remains nearly 65% of patients discontinue these treatments within the first year with many experiencing rapid we regained thereafter. According to a recent study in Jama only a minority of individuals who stopped taking <unk> drugs.
Speaker Change: Reinitiate therapy within one year.
Speaker Change: So while these drugs deliver initial success long term weight maintenance remains elusive for too many people caught in an unending pattern of loss and regain.
Speaker Change: Even as more drug options become available, it's becoming clear that non drug options will play a crucial role in long term weight maintenance. This is the single largest gap and obesity care today.
Speaker Change: Fractal is pioneering the first potentially durable solution to address the weight maintenance crisis, not just managing symptoms, but tackling the root cause of obesity in the duodenum with revere and developing a potentially one and done smart GOP, one gene therapy with <unk>.
Speaker Change: The unmet need is clear and we are driving as rapidly as possible to deliver important datasets to demonstrate the potential of our solutions to address this need.
Speaker Change: Today I'll take you through the defining milestones of 2024 and why we believe 2025 marks a pivotal step forward for <unk> as we are laser focused on our efforts to deliver long term metabolic health solutions to patients who need them.
Speaker Change: We made tremendous strides across clinical regulatory and financial milestones in 2024.
Speaker Change: We completed our IPO debuts on the NASDAQ under the ticker symbol guts strengthening our financial position.
Speaker Change: Secured FDA approval for a pivotal study of <unk> Rolling week maintenance following <unk> drug discontinuation setting the stage for a major value inflection point as we generate the industry's first ever randomized data in week maintenance a completely untapped market.
Speaker Change: Earned FDA breakthrough device designation for <unk> in weight maintenance after discontinuation of <unk> based therapy.
Speaker Change: Initiated the remain one pivotal study with an overwhelmingly positive response from both patients and physicians reinforcing the urgent demand for an off ramp to <unk> one drugs.
Speaker Change: Advanced our <unk> gene therapy platform nominating Rejuvenesce zero-zero, one as a first smart <unk> type two diabetes candidate and <unk> is a smart Gi P. G. L. P. One candidate for obesity.
Speaker Change: Received industry recognition with <unk> preclinical data being named the top abstract at 80 884 scientific sessions for our head to head study that showed bridge of our prevented weight and glycemic rebound after some advertising withdrawal.
Speaker Change: And completed key in vivo studies to support our clinical trial application for <unk> 001, laying the foundation for the next steps in this important program.
Speaker Change: Turning to 2025, we expect this to be a breakout year for <unk>, our first pivotal data readout, our first regulatory filings for our gene therapy platform and our clear path to market leadership in obesity and metabolic health.
Speaker Change: We have two distinct but highly derisked event paths, one for <unk> and weight maintenance and the other for <unk> ones path to first in human data in type two diabetes, we expect to achieve key clinical milestones from the remained one study in 2025, starting with open label data from the reveal one cohort expected at the end.
Speaker Change: Q1, our midpoint analysis anticipated at the end of Q2 and full study enrollment expected in the summer each milestone driving us closer to breakthrough advancements in weight maintenance. We also plan to submit the first Cta module for renewables zero-zero, one in type two diabetes to regulators in the first half.
Speaker Change: 2025, and if our Cta as authorized we expect to report preliminary data in 2026.
Speaker Change: Now, let's dive deeper into the progress we've made and what's on the horizon.
Speaker Change: In January we made the strategic decision to focus our reveal program exclusively on wheat maintenance post GOP one withdrawal prioritizing the remaining one pivotal study. This decision was driven by promising early insights from reveal one and overwhelming demand from both patients and physicians to participate in the remained.
Speaker Change: One pivotal study in.
Speaker Change: In just six months over 189 patients have enrolled across 13 clinical sites reinforcing the urgent need for an effective off ramp from <unk> one therapy.
Speaker Change: In January we also shared initial results from the first patient treated in the reveal one open label cohort. This patient lost more than 15% of their total body weight on a <unk> drug and after discontinuing per study protocol underwent the review the procedure one month post procedure that patients successfully maintained there.
Speaker Change: Weight loss during the holiday season are notoriously challenging time for weight management for.
Speaker Change: For context prior studies of <unk> appetite withdrawal of show an average 3% we regained within four weeks of <unk> discontinuation.
Speaker Change: These early findings suggest <unk> may provide a path forward for patients transitioning off GOP ones and we look forward to sharing additional patient data later this month.
Speaker Change: The financial pressures on current GOP, one treatments are becoming impossible to ignore with over 70% of U S. Adults affected by obesity driving an estimated $170 billion in annual medical costs payers are reassessing their coverage for example, west Virginia public employees insurance.
Speaker Change: Agency recently discontinued GOP, one coverage, citing unsustainable monthly costs and insurers in states like North Carolina, and Colorado are following suit amplifying the need for sustainable long term solutions. There is an interesting emergent dynamic in that obesity has become a health equity concern for public payers.
Speaker Change: And yet they're struggling to justify ongoing coverage of drugs that clearly work, but where their own real world evidence shows that adherence is a significant issue.
Singh: <unk> Singh director of Bariatric Endoscopy at West, Virginia University Medicine, and a pie in our reveal one study has observed that patients who have achieved weight loss with <unk> ones are now beginning to ask what's next he shared with me I'm excited to provide solutions for patients who otherwise have none there is <unk>.
<unk> interest in joining the study and then the prospect of long term durable weight maintenance solutions.
Speaker Change: Shifting focus to the remain one randomized pivotal study. This groundbreaking double blind trial is designed to evaluate the efficacy of our <unk> procedure and sustaining weight loss after discontinuation of <unk> drugs as the first study of its kind remain one places fractal at the cutting edge of.
Speaker Change: Patients in long term weight maintenance solutions.
Speaker Change: Let's frame what is a reasonable expectation for a clinically meaningful weight maintenance solution.
Speaker Change: The FDA has specified that weight maintenance is defined as the achievement and maintenance of clinically meaningful weight loss for one year after the discontinuation of ongoing therapy.
Speaker Change: And Theres surmount for study of <unk> appetite withdrawal, Eli Lilly reported that only about 16% of study participants maintained at least 80% of the way they had lost while on the drug one year afterwards.
Speaker Change: We believe that a weight maintenance therapy should at a minimum retain at least 50% of their weight loss at one year.
Speaker Change: A home run would be for a majority of patients to retain at least 80% of the way they had lost at one year.
Given the magnitude of the unmet need we believe this range of outcomes would be a tremendous victory for patients who need to maintain their hard one weight loss.
Speaker Change: And despite the development of a variety of products for obesity, ranging from peptides to small molecules to <unk> RNA approaches. We are unaware of any other product in development that has the potential to sustained metabolic benefits for more than one year after drug discontinuation like the ones, we're developing at fractal.
Speaker Change: The German real World Registry study in patients with type two diabetes has given us valuable data that validates our confidence in <unk> as a potential solution. We have seen impressive clinical results in the first tranche of 17 patients who've achieved one year of follow up.
Speaker Change: Despite the fact that these individuals represent a hard to treat patient segment at 12 months post <unk> procedure mean weight was reduced by more than seven kilograms within one month, and then sustained for one year thereafter.
Speaker Change: At 12 months post procedure, 94% of participants reported they would undergo repeat again and 100% would recommend the procedure to a family member or friend.
Speaker Change: To date, no device or procedure related serious adverse events have been reported.
Speaker Change: Think about what this means in a hard to treat patient population they undergo a procedure and one year later they are living their lives at a lower weight sustainably. We believe this is a very powerful clinical profile for weight maintenance therapy in a real world setting.
Speaker Change: Looking beyond data and with an eye towards commercialization, we plan to leverage our relationships with Gi Endoscopist, who specialize in bariatrics and metabolic endoscopy to build a scalable and efficient commercial model. These physicians have a built in patient base actively seeking sustainable weight management solutions.
Speaker Change: And a strong referral network from primary care providers the.
Speaker Change: The integration of <unk> into these existing workflows, where millions of <unk> procedures are already performed annually for patients with obesity creates a clear high volume opportunity for broad adoption.
Speaker Change: Unlike traditional drug based approaches reveal represents a durable procedure based intervention designed to fit seamlessly into the standard of care for patients transitioning off <unk> one therapy.
Speaker Change: We look forward to continuing to build out this targeted commercial model and discussing our path forward in future quarters.
Speaker Change: Now, let's talk about rejuvenate our next generation approach to metabolic disease.
Speaker Change: Unlike traditional GOP ones that bombard your system with high drug levels are smart <unk> candidates are designed for physiologically regulated expression more <unk> when you need it where you need it and how much you need. We believe this is the next generation of <unk> therapy.
Speaker Change: Moreover, the anticipated low viral doses can enable a low cost of goods and a new pricing model for gene therapies, because the patient population at risk is so large.
Speaker Change: This is a new commercial model for gene therapies, and one that we believe can overcome the challenges of commercializing gene therapies to date.
Speaker Change: At the end of last year at the World Congress for insulin resistance, we presented key preclinical data demonstrating the successful targeted delivery of Ridgewood Zero-zero, one our smart <unk> pancreatic gene therapy in large animal models, using our proprietary endoscopic ultrasound guided system.
We achieved safe and precise pancreatic delivery and Yucatan pigs at a low total viral dose closely mirroring our planned first in human studies.
Speaker Change: Results showed therapeutically relevant GOP, one expression within pancreatic beta cells with no adverse safety effects reinforcing <unk> zero-zero ones potential as a breakthrough approach for type two diabetes.
Speaker Change: We recently met again with German regulators and achieved alignment on our patient population and study design for the <unk> 001 person human study.
Speaker Change: Our primary focus will be to evaluate its safety and Tolerability. In this study is also designed to provide an early indication of potential efficacy to help determine the optimal dose for a future phase III study.
Speaker Change: We plan to investigate <unk> in a patient population with uncontrolled type two diabetes, who are on a <unk> drug and between 1% to three other non insulin glucose lowering agents.
Speaker Change: We're very encouraged by the positive dialogue with German regulators and the favourable feedback we have received thus far on our preclinical program and data and our upcoming Cta filing.
Speaker Change: And with this critical validation and alignment in place we are on track to submit this first Cta module to regulators in the first half of 2025.
Speaker Change: And if our Cta as authorized expect to report preliminary data in 2026.
Speaker Change: We hope to show, how our smart <unk>, one can reshape the treatment paradigm in metabolic disease and bend the curve toward remission.
Speaker Change: Obesity and type two diabetes.
Speaker Change: With that I will now turn the call to Lisa to provide an update on our fourth quarter and full year financials Lisa.
Lisa: Thank you Harry in the fourth quarter of 2024 revenue was generated from our commercial pilot in Germany and enabled patients enrolling in the German real World Registry study.
Speaker Change: Turning to operating expenses.
Speaker Change: Search and development expense in the fourth quarter of 2024 was $20 3 million compared to $10 1 million for the same period in 2023.
Speaker Change: The increase during the quarter was primarily due to the progress made in our remain one clinical study. The revitalized one clinical study continued development of the virtue of our platform and increased personnel related expenses, including stock based compensation.
Speaker Change: Selling general and administrative expense in the fourth quarter of 2024 was $4 9 million compared to $2 8 million in the same period in 2023.
Speaker Change: The increase during the quarter was primarily due to the increased cost associated with operating as a publicly traded company and increased personal related expenses, including stock based compensation.
Speaker Change: For the fourth quarter of 2024, we reported a net loss of $25 million compared to a net loss of $19 2 million for the same period in 2023.
Speaker Change: Increase in net loss is primarily attributed to the increase in operating expenses discussed above.
Speaker Change: Offset by the noncash gain from changes in fair value of warrant liabilities as well as an increase in net interest income.
Speaker Change: As of December 31, 2024, Frac, Don had approximately $67 5 million in cash and cash equivalents.
Speaker Change: Based on our current development plans, we believe that our existing cash and cash equivalents will be sufficient to fund our operations.
Speaker Change: Key anticipated clinical milestones into 2026.
Henry: I'll now turn the call back to Henry.
Henry: Thank you Lisa.
Henry: We're not just participating in the obesity Revolution, we are defining it.
Speaker Change: The earliest days in this market with products that showed tremendous promise and yet large unmet needs that remain.
Speaker Change: This is our moment to lead and we are moving with urgency 2025 will be the year that we show the world that weight maintenance is possible.
Speaker Change: The work we are doing today has the power to change millions of lives offering real lasting solutions beyond temporary fixes the demand is clear the <unk>.
Speaker Change: <unk> is strong and our path forward is bold it takes guts.
Speaker Change: I want to take a moment to express my deep gratitude to the patients and physicians who place their trust in us to the dedicated employees at fractal, who are relentless in their pursuit of life changing therapies and to you our shareholders, whose support fuels our mission your belief in our work drives us forward and we have never been more.
Speaker Change: And our ability to deliver on our promises and with that we will now open the call up for questions. Thank you.
Speaker Change: As a reminder to ask a question you will need to press star one one on your telephone to remove yourself from the queue. You May press Star one again, please standby, while we compile the Q&A roster.
Speaker Change: Our first question.
Jason Fairbury: Comes from the line of Jason Fairbury Bofa Securities.
Speaker Change: Your line is open Jason.
Jason Fairbury: Hey, guys.
Speaker Change: <unk> Jason.
Speaker Change: Our questions.
Speaker Change: I guess the first one I wanted to touch on remaining one so.
Speaker Change: You are expecting a 12 week.
Speaker Change: Analysis late in second quarter.
Speaker Change: Right at the start of the second quarter now so presumably you have a line of sight on how many patients.
Speaker Change: We have achieved the pre specified 15% total body weight loss and those who have subsequently been randomized two to one to receive <unk> sure.
Speaker Change: Sure sure.
Speaker Change: So I'm, hoping you can elaborate if you have randomize already randomized roughly 40 patients or so.
Speaker Change: Our expected putting any analysis.
Speaker Change: And Kiwi is what are the dropout rate so far that is patients getting reinsurance appetite, but don't follow through with the randomized portion of the study.
Speaker Change: Hi, Thank you for the call and the question I think that as of this morning. There were nearly 100 patients who've achieved either 15% body weight loss or close to it.
Speaker Change: Substantial.
Speaker Change: Number of the proportion of <unk> 45 have been randomized and or procedures are being scheduled.
Speaker Change: What I can I don't know the exact number off the top of my head, but what I can tell you is that there is not a single patient who has dropped out of the study because.
Speaker Change: They have.
Speaker Change: Wanted to undergo the procedure. So far so every patient who has hit 15% body weight loss and who's had a procedure who has been scheduled has undergone that procedure and we're gratified by that fast because as you know there is a question about whether patients might just enrolling the study in order to get towards appetite and then not.
Speaker Change: Be interested in the procedure itself that has not been an issue that we have observed thus far and with respect to the exact timing of the midpoint analysis, we will be giving updates along with reveal one data at the end of this month, but we remain on track based on what we're seeing right now.
Speaker Change: Great Thats like this that way to my second question.
<unk> so on reveal one.
Speaker Change: If data are expected later this month.
Speaker Change: What sort of format and then do you have in mind for that data at the <unk> closure.
Speaker Change: Can you remind us just spectation of the reveal one data I know you have breath right comparison advertisement firsthand waking up to four weeks.
Speaker Change: Remind us what your expectation of the easier one first date SaaS.
Speaker Change: We expect a lot of data variability from that 10 patients or so.
Speaker Change: We're having some background from the operator.
Speaker Change: But I'll go ahead and.
Speaker Change: And answering your question I'll repeat your question Chi and then we will we will.
Speaker Change: And then we will get so what you are asking is what is the expectation for how we're going to present the data and then also the variability there I can tell you that.
Speaker Change: This is a more heterogeneous patient population than remain one as you may remember for the audience as you may remember and remain one we're taking individuals who are obese who are <unk> one drug naive.
Speaker Change: Providing tours appetite titrated them to 15% body weight loss, and then randomize them.
And in the process of after stopping their tours appetite and what that allows is a more or less homogeneous group of individuals who have lost a little bit over 15% total body weight loss in reveal we are enrolling subjects, who have already been on either some idle as hydro <unk> appetite the majority of them have been on <unk> appetite.
Speaker Change: But they have lost varying amounts of weight relative to what you would expect to see from the remains study will be shared already has a single individual who loss between 17 and 18% total body weight, who has followed through her one month visits in January.
Speaker Change: And roughly six weeks after <unk> appetite discontinuation and little bit more than a month after.
Speaker Change: The review the procedure she had not regained any body weight and had not been feeling any ill-health. So what we hope to be able to show.
Speaker Change: With the press release in the end of the month.
Speaker Change: Is a.
Speaker Change: Clear picture of this group of open label patients when reveal one and to be able to give enough information to be able to unpack how you might translate that into what you would expect to see from remain.
Speaker Change: Got it and just last quick one from me I'll re queue.
Speaker Change: Can you talk about what are the gating items, we need to complete before.
John: Thanks, John.
Speaker Change: 25.
Speaker Change: Can you talk about this before but I'm, hoping you can fine tune where youre at.
Speaker Change: The process and are you still planning to initiate a first in human study in first half.
Speaker Change: Right. So we provided additional clarity on that in our guidance today, we are going to be filing our first Cta module in the first half of the year. There are theres a device module and a drug module. The device module is going to have certain preclinical.
Speaker Change: <unk> testing that needs to be completed in addition to the in vivo testing on <unk>.
Speaker Change: Enabling studies that had been done like aging and biocompatibility. So those are the sorts of things that remain on the device side of the house and on the drug side of the house, we have some remaining CMC assay test and final testing to be completed before the drug is complete and we.
Speaker Change: Are going to initiate that submission in the first half of the year as we had previously discussed.
Speaker Change: Okay, great. Thanks, so much thanks.
Speaker Change: Thank you.
Speaker Change: Our next question comes from Michael Rose.
Speaker Change: Organ Stanley. Please go ahead Mike.
Speaker Change: Great Good afternoon, and thanks for taking my questions maybe.
Speaker Change: Maybe just a follow up on reveal the reveal one open label portion of the study you mentioned planning to give an update sort of.
Speaker Change: End of this month, just curious number of patients you plan to share I think in the past you were suggesting maybe around 10 patients is that still the case, yes. That's still the case, we've actually just been constraining the size of that study as we have been also focusing on enrolling remain and so we are continuing to leave.
Speaker Change: We've enrolled.
Speaker Change: North of 10 patients so far and we are planning on sharing about 10 patients worth of data by the end of the month.
Speaker Change: Okay great.
Speaker Change: And then maybe just.
Speaker Change: Do you have a question more on <unk> two if you could just remind us.
Speaker Change: Or give us an update there on the status of that program and next steps there. Thanks.
Speaker Change: So.
Speaker Change: <unk> is a smart <unk> dual and <unk>. It's a it's the same delivery catheter that we developed for <unk>, one and it is the same.
Speaker Change: <unk> nine backbone the differences that it will it's a plasma that will express both Gi and <unk> one that's still in preclinical testing and we have not provided guidance at this time on when that will go to the clinic, we do believe that renewable old one in preclinical studies has demonstrated efficacy.
Speaker Change: It's gone both blood sugar and on body weight, we are planning to enroll patients who are have obesity and type two diabetes in the first in human study and we believe that we're going to learn a great deal about dosing from renewable one that will inform how we plan to dose <unk> in patients as well.
Speaker Change: And so as we make more progress on <unk> in the clinic, our path to the clinic and then into the clinic, we will give you a guidance on <unk> timeline to a person human as well.
Speaker Change: Great. Thanks, again for taking my questions. Thanks.
Speaker Change: Yeah.
Speaker Change: Thank you.
Speaker Change: Next question.
Michael: Comments from Michael <unk> of Evercore ISI. Please go ahead Michael.
Michael: Hi, guys. Thanks, so much for taking my questions and congrats on all the progress just two quick ones from me regarding that first.
Michael: Patient in revealed.
Michael: That maintained her body weight is there any is there any update on that patient in terms of how far how much further along.
Michael: He is and whether she still has maintained we're not gained any weight back and have you done any further.
Michael: Further workup or even biomarker analysis on that patient to maybe shed some more light on.
Michael: Durability or even.
Michael: Mechanism for that matter. Thank you.
Michael: Thanks, Mike.
Speaker Change: I don't have any additional information to share at this time.
Michael: <unk>.
Michael: We will have more information in due course, and one of the nice things about the reveal one open label study is that they are.
Michael: Plan to continue to follow these patients beyond early follow up as you know so we're going to share one month data in a cohort, but we certainly will be following that up with three months and six month data when we have it but I have no specific additional information to share at this time.
Speaker Change: Got it and just one quick follow up more of a commercial type of question or are there any plans assuming the reveal one and remained midpoint analysis is stellar cut maybe are there any plan to seek potential.
Michael: Potential strategic strategic partnerships or collaborations to.
Michael: Maybe bolster commercialization efforts and share development costs.
Michael: Yes.
Michael: Great question, Mike, we're talking to a lot of the major players in the space I believe that this is a study and then endpoint and an unmet need that is very much on a lot of people's minds.
Michael: And.
Michael: I think that there are a lot of people who would be interested in this therapy and the opportunity.
Michael: Got it thanks, so much.
Speaker Change: Thank you our next.
Michael: Next question.
Michael: Come from the line of William Blair.
Michael: B Riley Securities. Please go ahead William.
Speaker Change: Thank you so much and congratulations on a very nice quarter.
Michael: Quarter.
Michael: A couple from us.
Michael: Just one brief one on <unk>, I guess sort of a couple of <unk>.
Speaker Change: Fine tune reveal one I'm just kind of curious as we move throughout the year, you said you'd be providing additional data points and weight loss or weight maintenance I guess, but when upon those readouts would we expect sort of increasing data, including biomarkers, possibly body composition or other events or are there are.
Michael: Additional data analysis.
Speaker Change: And then additionally, do you think.
Speaker Change: Your stand at least and remain it's only or is that the time based population, but do you or would you potentially expect differences in weight regain.
Speaker Change: Based on whether the patient originally took summer or towards appetite.
Speaker Change: Just with differences in body composition after those two drugs or any other differences in those weight loss dynamics.
Speaker Change: A follow up thank you.
Speaker Change: Thanks, Willie I appreciate it so we are collecting blood and doing lab work on.
Speaker Change: Testaments on blood sugar parameters cardiovascular parameters and also measuring leptin as a biomarker for body fat mass content and so we will be.
Speaker Change: Compiling those data and then sharing them later on in the year for reveal.
Speaker Change: <unk>.
Speaker Change: While we expect top line data or remain at the end of Q2, we do plan to continue to investigate blood sugar and other assessments as well.
Speaker Change: Porting later on although I can't guarantee that all of that will be available right upfront with respect to the weight regain.
Speaker Change: Our analysis and we've looked at this extensively is that the way regain from some magnetite and tours appetite does not depend so much on the drug that they're on but rather on the time of course since the discontinuation of the medicine and so that's part of what we think is important to share.
Speaker Change: There as we work through the reveal data set so that people can understand how to think about what rubido may be doing from the open label cohort as a prelude to the randomized data coming thereafter.
Speaker Change: Excellent I appreciate that extra color and then.
Speaker Change: In terms of you mentioned that there has been.
Speaker Change: A couple of states or I guess, maybe even numerous states that have either rejected ensuring are recovering obesity treatment and then there's been others that have sort of put it on the table and either accept it or even sort of turn back the clock on it.
Speaker Change: <unk> gone to any of the states.
Speaker Change: Our bodies that have potentially had the sort of back and forth thoughts on obesity treatment and sort of seeing what their idea is one.
Speaker Change: <unk>.
Speaker Change: On the DMR sort of.
Treatment and if they if this is something that they look at them. They're like Oh. This is we are actually very interested in this sort of a part from say FDA or or a broad insurance program. Just curious are those clients. We have had some conversations with with.
Speaker Change: Public payers and I think we have a good understanding for what they view their pain points to be I think that the proof will be in the data that we generate from remain in the pivotal study in order to be able to articulate the value proposition more crisply, but what I can say.
Speaker Change: Is that the.
Speaker Change: Desire to be able to address obesity in a holistic way and in a cost effective manner is now very clear I do not believe that that was perceived to be a need by payers five years ago, but I do believe that that is a groundswell that is occurring currently.
Speaker Change: And I believe that the public payers see that.
Speaker Change: As much as the employers do.
Speaker Change: So what we are aiming to be able to do with the remained study, which I think it is incredibly well designed to do that is to demonstrate a holistic strategy for durable weight maintenance that we believe will be highly attractive, but we'll have more to say about that with data in hand as we pursue.
Speaker Change: The program over the coming quarters.
Speaker Change: Got it understood.
Yep.
Speaker Change: They're all back in the queue I appreciate you taking my questions and congratulations again, thank you.
Speaker Change: Thank you once again to ask a question. Please press star one on your telephone Thats Star one to ask a question.
Speaker Change: I would now like to turn the conference back to Dr. Roger Copolymer Park closing remarks, Sir.
Speaker Change: Thank you very much thanks to everyone for joining us. This afternoon as always we appreciate your continued interest in and support of fractal and we look forward to continuing to sharing updates on our progress as we address weight maintenance in the coming months look forward to speaking with you again shortly.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.
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