VectivBio Holding AG (NASDAQ:VECT) Q4 2021 Earnings Conference Call April 7, 2022 8:00 AM ET
Company Participants
Luca Santarelli – Founder and CEO and Board Member
Claudia D’Augusta – Chief Financial Officer
Christian Meyer – Chief Operating Officer
Omar Khwaja – Chief Medical Officer
Kevin Harris – Chief Commercial Officer
Conference Call Participants
Thomas Smith – SVB Leerink
Tazeen Ahmad – Bank of America
Patrick Dolezal – LifeSci Capital
Tiago Fauth – Credit Suisse
Operator
Ladies and gentlemen, thank you for standing by. Welcome to VectivBio’s Conference Call to report Full Year 2021 Financial Results. My name is Livia, and I’ll be your conference operator for today’s call. [Operator Instructions] As a reminder, this call is being recorded at VectivBio’s request.
Now, I would like to introduce your host for today’s call, Claudia D’Augusta, Chief Financial Officer. Please go ahead.
Claudia D’Augusta
Thank you and good morning, everyone. Welcome to today’s call during which we will provide an update on the company and review our financial results for the full year ended December 31, 2021. Earlier this morning, we issued a press release summarizing our financial results and progress across the company, which is available on our website.
I would like to remind everyone that today’s discussion will include statements about our future expectations, plans and prospects that constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including the risk factors discussed in our SEC filings, and we’re not under any obligation to update any forward-looking statements.
Joining me today here in Basel are Luca Santarelli, Chief Executive Officer and Omar Khwaja, our Chief Medical Officer. We estimate that our remarks will take about 20 minutes, then we will open up to Q&A, at which point we will be joined by Kevin Harris, our Chief Commercial Officer, who is based in the U.S.
Now I’d like to turn the call over to Luca.
Luca Santarelli
Thank you, Claudia, and thanks to everyone for joining us today. At this first financial results call, I’ll begin with a brief introduction to our company. For those new to our story, VectivBio is a late-stage biotech company developing transformational drugs for rare conditions with high unmet need.
We are a team of industry veterans with a successful track record in rare diseases, deep scientific expertise in a relentless focus on the patient. Our purpose is to identify and develop therapeutics that are both transformational and tailored to patient’s needs. In a short amount of time since our founding in 2019, we have made considerable progress on our way to achieving this purpose.
Our lead molecule is apraglutide, a next-generation GLP-2 analog. As a result of enhanced pharmacology and innovative development programs, we believe apraglutide will unlock the full therapeutic end market potential for the GLP-2 mechanism of action. Apraglutide is currently in Phase 3 in short bowel syndrome with intestinal failure or SBS-IF and in Phase 2 in acute graft-versus-host disease or GvHD. SBS-IF and GvHD are both underserved markets, representing a blockbuster opportunity for apraglutide.
Regarding SBS-IF this is an established, but yet under penetrated market that we believe is poised for significant growth. There is only one approved drug for SBS-IF, a first generation GLP-2 analog called Gattex. Despite its limited adoption and persistency due to the short half-life [ph] in a burdensome administration regimen, Gattex add an estimated revenues of approximately $670 million in fiscal year 2021.
Our goal is to demonstrate that treatment with apraglutide results in better outcomes for SBS patients, leading to broader adoption and improved persistency. To that end, in just a few months, we’ll present interim data from our STARS nutrition study that aims to demonstrate that apraglutide can improve intestinal absorption in a subgroup of SBS patients with colon-in-continuity or CIC. And this is a patient subgroup where there is limited data supporting the use of Gattex. If positive this result — these results may substantially de-risk the ongoing Phase 3 study ahead of data next year, as well as offer promise for a broader adoption for apraglutide CIC patients.
In GvHD, apraglutide aims to be the first non-immune suppressive treatment to address GI damage, while the most critical complication of this disease leading to significant mortality. This approach is supported by recent scientific discoveries that have established the therapeutic potential for GLP-2 in acute GvHD. Lastly, we have the financial runway to take us well beyond our main catalysts, the Phase 3 results in SBS and the proof-of-concept study in GvHD.
Now looking back, 2021 was a very important year for us. And I can’t overstate how proud I am of this team for the significant progress we made against key business objectives, including a successful IPO in April. The launch of the STARS program, a multi-study pivotal program to support the approval of apraglutide in SBS intestinal failure. The initiation of STARS nutrition in CIC patients; the achievement or orphan drug designation and IMD clearance for apraglutide in GvHD.
The acquisition of Comet, a modular platform targeting a class of rare inherited metabolic diseases collectively affecting over 75,000 patients for whom there is no approved treatment. This platform has the potential to fuel pipeline in multiple small molecule drug candidates, the first of which is due to enter the clinic next year.
Also 2022 is off to a great start. Since the beginning of this year, we continue to successfully recruit our Phase 3 study and our Phase 2 study within the STARS program, which will enable us to report interim CIC results later this year and Phase 3 top line results by the end of 2023. Omar will provide more details on our clinical strategy that has enabled us to stay on track even during the pandemic.
We launched STARGAZE, our POC study in acute graft versus host disease, currently recruiting patients in the U.S and Europe. And just last week, we announced the Japan licensing deal with Asahi Kasei Pharmaceuticals for apraglutide in a debt facility with Kreos Capital. These two deals combined with our current cash provide a financial runway that takes us well beyond our main catalyst. AKP partnership also provides external validation for the best-in-class potential of apraglutide, and brought us our geographic footprint beyond U.S and Europe.
Now, I would like to turn the call over to our Chief Medical Officer, Omar Khwaja, who will share additional details on our pipeline programs. Omar, over to you.
Omar Khwaja
Thanks, Luca, and good morning, everyone. I’d like to further elaborate on three aspects of our apraglutide clinical development program. Firstly, while we believe apraglutide is the best-in-class GLP-2 agonist; then how our STARS program aims to deliver a differentiated label in SBS-IF to support broader adoption. And finally, while we think it will provide a novel non-immunosuppressive option to patients with acute graft-versus-host disease, who do not respond to steroids.
Apraglutide is rationally designed to have enhanced pharmacological properties, such as increased receptor potency and selectivity, versus other GLP-2 agonist, and an increased half-life of 72 hours. We believe that these properties not only enable weekly dosing, but also may translate into greater efficacy, increased tolerability and persistency of use, and potentially better outcomes.
To support our belief in head-to-head preclinical studies, apraglutide demonstrated greater intestinal pharmacological effects when compared to other GLP-2 agonists, a proxy that could translate to enhanced efficacy in the clinic. In Phase 2 studies, apraglutide was the only GLP-2 analog to increase intestinal absorption of the weekly dosing as well as demonstrate statistically significant improvements in calorie absorption.
We believe that the GLP-2 mechanism with its potent effects on intestinal epithelium regeneration, healing and maintenance of intestinal barrier function; affords broad clinical applications in severe gastrointestinal and liver disorders. And as such, apraglutide represents a pipeline and a product. With that terms we’re pursuing a novel clinical strategy across a range of indications.
We’re beginning with the STARS pivotal program that will support a differentiated label and improved outcomes in SBS-IF, a disease in which the GLP-2 mechanism of action is clinically validated. We designed the STARS program with pre-specified primary and key secondary endpoints to differentiate apraglutide from competitors to prospectively demonstrate meaningful efficacy and patients with colon-in-continuity that now represent a majority of patients with SBS-IF and [indiscernible] increased value to prescribers, patients and payers.
We based on developments and differentiation strategy, and what has been learned in the last decade in SBS. Gattex was approved in 2012 based on its ability to reduce the volume of parenteral support or PS required by SBS patients. We believe that physicians also want to understand the clinical impact that PS reduction has on patients’ lives. Treatment goals for SBS-IF should be the reduction of number of days on PS, and wherever possible and full autonomy, which is the elimination of the PS dependency.
On further assessments of real-world evidence, the clinical experience of experts in intestinal failure and post hoc analysis of the Gattex Phase 3 trials, indicate that the response to GLP-2 and SBS is heterogeneous and highly contingent on a patient’s random [ph] post-surgical anatomy.
Fundamentally, there are two distinct subtypes of SBS-IF. Patients were the remaining short and small intestine [indiscernible] stoma bag, and patients where the remnant small bowel is connected to the colon, otherwise known as colon-in-continuity or CIC. In designing the STARS program, we have prioritized clinically meaningful outcome measures or assessing patient reported outcomes and have implemented a tailored approach to allow distinct assessment to stoma and CIC patients.
Unlike previous studies assessing other GLP-2s in SBS-IF, the STARS program is the first to prospectively evaluate safety and efficacy in each subpopulation, stoma and CIC. In addition, with 144 patients, and a duration of up to 12 months, it has power to detect improvements in enteral autonomy and quality of life in each population.
Rules enrolling patients in STARS nutrition and supplemental first of its kind, metabolic balance study in SBS CIC patients to represent over 60% of the total SBS-IF population. We will be reporting interim results from this study at a Scientific Congress in the second half of 2022, including the quantitative effects of apraglutide on intestinal absorption and stool output.
With the Phase 2 data already having demonstrated apraglutide’s efficacy on these outcomes in the stoma population, we believe that STARS nutrition has the potential to highlight apraglutide’s unique benefit to CIC patients. Should this data read out positively, it may substantially de-risk the ongoing Phase 3 study ahead of beta next year, since improvements in intestinal absorption reduction in PS requirements.
Let me conclude the STARS update with a short comment on our operational strategy that was designed to withstand the challenges faced during the COVID pandemic. We have so far activated 75 out of a total 80 sites, spanned across 18 countries, including the U.S., Europe, Asia and South America. This broad footprint, combined with unique remote trial capabilities, has enabled us to stay on track for steady recruitment. And I’m pleased to say we’re able to maintain our guidance to report top line data from the STARS Phase 3 study by the end of 2023.
Apraglutide beyond SBS-IF, we’re also developing apraglutide as the first in class regenerative and non-immunosuppressive treatment for acute GvHD. Approximately 26,000 allogeneic stem cell transplants occur annually in the U.S., Europe and Japan. Our target patients are those who develop acute GvHD become refractory to first line steroids, and present with severe GI symptoms of GvHD, a group we estimate comprises around 4,000 patients per year.
GvHD of the gut results from damage from bone marrow conditioning for the transplant, as well as donor T cell attacks on the GI tract. These results cause severe damage to the gut epithelium, resulting in severe malabsorption and diarrhea and loss of integrity of the intestinal barrier. Mortality among these patients is 50% at 6 months, and it’s driven in large part by the severity of GI symptoms. The rationale to develop apraglutide in this condition is supported by two datasets.
[Indiscernible] simple experiment, demonstrated that apraglutide can increase survival in the murine model of GvHD. In addition, there is recently published clinical data showing that GLP-2 agonists can reduce GI symptoms and promote regeneration of the gut epithelium in patients with steroid refractory GvHD.
STARGAZE, our Phase 2 study obtained regulatory clearance last year, and we’ve activated sites in the U.S and Europe, and expect to dose our first patients in the coming weeks. This study is evaluating apraglutide in combination with systemic corticosteroids and ruxolitinib in patients with steroid refractory acute GvHD. We look forward to reporting interim data from this proof-of-concept study in the first half of 2023.
Turning finally to Comet. Since the acquisition of the platform, we’ve made rapid progress in the development of our lead molecule VB-1197 for the treatment of severe life limiting organic acidemia, specifically methylmalonic and propionic acidemia, and are on track for entry into the clinic in 2023. We’re very excited about the promises of our pipeline, and I look forward to updating you on these upcoming milestones in the future.
With that, I will now turn the call over to our CFO, Claudia D’Augusta to discuss our 2021 financial results. Claudia?
Claudia D’Augusta
Thank you, Omar. I will briefly comment now on the key financials for the year 2021. Our operating costs in 2021 were US$87 million, compared to US$57 million for 2020. We’re approximately 50% increase on a year-over-year basis. This US$30 million increase includes an approximate US$7 million increase in R&D expenses due to the progress of our STARS program, which encompasses certain offsets for accounting recognition related to contingent liability, and an approximate US$22 million increase in G&A expenses. This G&A cost increase was comprised mainly of non-cash personal costs related to long-term equity incentive plan, as well as the cost involved in the preparation of the IPO and operating as a public company.
We ended 2021 with cash and cash equivalents of US$103 million. In addition, as Luca mentioned, the two deals we announced last week significantly strengthened our financial position. First, our collaboration agreement with AKP provides a US$30 million upfront, as well as eligibility for US$170 million in downstream development milestones, plus royalties on sales of apraglutide in Japan.
Second, a credit facility with Kreos Capital, providing flexible access to up to US$75 million. Together, these two transactions combined with our cash available of US$103 million at the end of 2021 provide us with up to US$220 million in near-term operating capital and extend our cash runway beyond our Phase 3 STARS top line results.
Now, I’d like to hand the call back to Luca.
Luca Santarelli
Thank you, Claudia. We covered a lot of ground during today’s call. And to close, I’d like to underscore the following points. First, our lead molecule apraglutide is a next generation GLP-2 that has a potential best-in-class profile, which we believe will result in better outcomes for patients leading to broader adoption and improved persistency.
Secondly, apraglutide is entering an established but yet underserved market that we believe is poised for significant growth. As a reminder, there is only one GLP-2 approve for short bowel syndrome, and despite limited adoption due short half-life and burdensome administration, it is generating approximately US$670 million in fiscal year 2021.
Next, the STARS development program. We provide a robust data set aimed at delivering a differentiated label to optimize launch and reimbursement. Also, in just a few months, we will present interim data from our STARS nutrition program, with the aim to demonstrate that apraglutide is able to improve intestinal absorption in CIC patients, a patient population when there is limited data supporting the use of Gattex. If positive, these results may substantially de-risk the ongoing Phase 3 study ahead of data next year and also indicate that apraglutide has the potential to respond GLP-2 use.
And finally, we’re on track to the dose our hospital patient in the STARGAZE proof-of-concept study in acute GvHD this quarter, and we are on track to read our top line results during the first half of 2023. Coupling those factors with the financial runway to take us through the Phase 3 STARS readout, I’m sure you can understand why we are so excited about what the future holds for VectivBio.
With that, we would like now to open the call for questions. Operator?
Question-and-Answer Session
Operator
[Operator Instructions] And our first question coming from the line of Thomas Smith with SVB Leerink. Your line is open.
Thomas Smith
Hey, guys. Thanks for taking the questions. Hey, can you guys hear me?
Luca Santarelli
Yes.
Thomas Smith
Okay, great. Yes. Thanks for taking the questions. Congrats on all the progress and the two recent deals. A couple of questions on our end. First on the STARS nutrition study. Can you talk a little bit more about enrollment? And I guess any early efficacy signals, you’re seeing there? What data do you expect to have available for presentation later this year? And maybe just walk us through your expectations for this data set? Like what’s the positive results look like here? Do you need to see a statistically significant change on energy absorption from baseline? Or do you need to see changes in PS volume? Just any idea what a good data set looks like from your perspective would be really helpful. Thanks.
Luca Santarelli
Thanks for the question. So, the study is recruiting well, it’s recruiting according to schedule. And we anticipate reporting results later this year at a conference. We are incorrigible on what we have seen so far, and by what we believe there is benefit in letting the data mature and run the full analysis as opposed to a subset. So, in terms of defining the — what success looks like, let me just remind that there hasn’t been any prospective study clinical trials that have shown a response of a GLP-2 analog in CIC patients.
And so, what the study is designed to do, at least for the interim readout, is to demonstrate that apraglutide can improve absorption parameters — intestinal absorption parameters in CIC patients. So, our ability to demonstrate such an effect would be unprecedented. And they would bode well for the Phase 3 study, because improving absorption parameters such as fluids and nutrients is key to drive the ability to reduce [indiscernible] support, which as you know, is the primary endpoint of the Phase 3 trial.
Thomas Smith
Okay, great. That’s helpful. And just to clarify, Luca, I guess, when we see data later this year, is it your expectation that we would have kind of that full cohort of temptations from the STARS nutrition study? And, I guess what time points do you expect would be available for evaluation at that point?
Luca Santarelli
Yes, we will have 10 patients and as communicated before, we will look at the 4-week metabolic balance assessment. This is 4-week out of a 48-week study. And it’s the same time point that we had performed as an assessment in our Phase 2 study in stoma and the same Type 1 that has been used in the past without the GLP-2s in stoma patients. So, it’s a very early time point. At the same time, if we do see an improvement in absorption in such an early — at such an early stage in treatment, again, this is very promising, because it would — again, these patients, the CIC patients are anticipated to take longer to respondents to our patients. So, if we see a response in absorption parameters at 4 weeks, this will be very promising.
Thomas Smith
Okay, got it. Understood. And then just a quicker one on the Japan deal with AKP. Can you just talk a little bit more about the strategic rationale and the process here? Like how competitive was the process and why do you think AKP is kind of the ideal partner to drive success in Japan?
Luca Santarelli
Thanks for that question. So, the rationale for the deal, it was that we wanted to — its multiple fold, but the primary rationale is that we wanted to maximize the value of apraglutide by accelerating access to Japan. And for that, obviously, we needed a Japanese partner. So, over the last 2 years, we have committed to a commercial strategy to launch ourselves in the U.S and Europe and to identify partners for other key markets. And in keeping with this strategy, we have implemented a Phase 3 trial where we are recruiting patients globally, including Asia, Latin America, in addition to the U.S and Europe.
Now, the other advantage of this deal is that it provides us with near-term cash to fuel our business. As we have communicated, there are US$30 million in upfront and near-term cost sharing that we’re getting right away. And then additional milestones that we’re going to get before the completion of the STARS program and others that we’re going to get later in development, as well as regulatory and commercial. Now, up to a total of US$170 million in milestones.
In terms of AKP and why we have chosen them, this is a company that has a long experience of commercializing products that are generated in other Western countries and in partnering with Western companies. They have a proven history of successful drug development, commercialization in GI, immunology in hematology, and they were hospital business with approximately 600 medical representatives and they are also committed to expanding their rare disease business. And these are the reasons why we have chosen them.
So just lastly, to conclude, yes, this was a competitive process. We had several offers for our products. I can’t disclose the details of that, but it was a competitive process, which was organized and ran over the last 6 months and led to the choice of the best partner, both in terms of compatibility with our product, but also in terms of financial aspects.
Thomas Smith
Okay, got it. Super helpful. Thanks, Luca and thanks — yes, thanks guys for taking our questions.
Luca Santarelli
Thank you.
Operator
And our next question coming from the line of Tazeen Ahmad with Bank of America. Your line is open.
Tazeen Ahmad
Hi, good morning, guys. Thanks for taking my questions. For the acute GvHD, I think that you have the interim reading out in the first half of [indiscernible], what are you looking for there? And what should we consider to be a good interim read from that study? And then secondly, Luca, maybe I wanted to ask you about the recent article from Zealand [ph] CEO that I think appeared in a Danish newspaper, where he specifically talks about their particular products with apraglutide for their attempt to treating short bowel syndrome and what do you think it means that they’re highlighting that particular candidate or what do you think the read-through is for Vectiv on that? Thank you.
Luca Santarelli
Thanks for question. Okay, I will — let’s get to the first question first. I’m going to have our Chief Medical Officer, Omar Khwaja respond the question. That was about the — what are we going to read out the interim analysis, describe what are the endpoints and how is that relevant to the rest of the program in GvHD, yes.
Omar Khwaja
Yes, right. Thanks, Tazeen, for the question. I mean, maybe just briefly review what the study is. So, the Phase 2 proof-of-concept study assessing two dose levels of apraglutide in a blinded fashion and up to 35 patients with steroid refractory acute GvHD. The comparators and external control are partly derived from the reach to pivotal study of ruxolitinib. At the interim, we — at this stage reporting, initial response data, both partial and overall responses in patients at day 28 and day 56 and a subset of about 14 to 15 patients. And we’ll be looking to benchmark that against external control arm.
Tazeen Ahmad
Okay. And …
Luca Santarelli
Yes, Just to add on top of that, obviously, the benchmark is the data set that came from REACH 2 study and includes about 150 patients from the ruxolitinib. And of course, we know exactly what are the expected overall and partial complete responses rates at week 12 — at day 28 and day 56. And that’s really — obviously there is a lot of room to improve upon those numbers. And that’s what we’re going to be looking at.
Tazeen Ahmad
Okay.
Luca Santarelli
All right. So, then the second question you asked — let me just ask the second question, you asked was about the read-through from the interview in the Danish media, which was an interview mentioned in the news media where the new CEO of Zealand, the former CMO singled out glepaglutide. I mean, I think what he did say, and he was also in the communicate — public communications is that they consider glepaglutide the most valuable asset. And in that, like all I can say is that we agreed that I won’t comment specifically on the context of that comment within our company, but I can say one thing is that one thing we agree and that is that SBS’s incredible valuable market is underpenetrated. Gattex is penetrated no more than 20% of it and is — as a turnover of close to US$700 million last year. So, I think the — I would agree that the SBS and next generation GLP-2 is a valuable opportunity for us [indiscernible] time.
Tazeen Ahmad
Okay, thank you.
Operator
Our next question …
Luca Santarelli
Thank you. Yes.
Operator
Our next question coming from the line of Patrick Dolezal with LifeSci Capital. Your line is open.
Patrick Dolezal
Hi, thanks for taking the questions. So just, if you can, it’d be great if you could provide a little additional color in terms of just why STARS nutrition study was just delayed a little bit. Just curious about the largest contributing factors to enrollment. Is it competing therapy, is COVID, just [indiscernible] being a rare condition? And then as we think about the pivotal STARS study, are there any implications on enrollment there? And then just curious if there’s any overlap insights and kind of how you’ve been prioritizing enrollment between those two studies? Thanks.
Luca Santarelli
Now let me clarify. The study was not delayed. We are on track to where we want it to be. We — and we are encouraged for what we have seen so far. But we think there is benefit in letting the data run the full analysis and mature as opposed to looking at a subset of data. And so, we have decided that we’ll do this in the context of a peer review conference in the fall rather than doing it earlier. But the recruitment progress with the study is actually as anticipated.
Patrick Dolezal
Got it. That’s helpful. And then I guess, if you could just speak to the unmet need, and SBS-IF patients with renal comorbidities considering dose reductions are required in this patient’s subset, just curious if responses are also suboptimal? And then if you could just provide additional color on the data that was recently presented in these patients using apra? Thanks.
Luca Santarelli
Yes, I will let Omar, respond that question. Omar about the renal impairment patient.
Omar Khwaja
Yes. So that 28% of patients with SBS-IF have moderate to severe renal impairment with Gattex that requires a dose adjustment to half the dose. There isn’t evidence particularly on whether that makes a difference to efficacy. But what was important for us is, first of all, our presentation of apraglutide, which is a 5-milligram flat dose, that — whether or not that would require dose adjustments in patients with renal impairment and it doesn’t. I mean, that’s the data that we presented that we’re able to use the same 5 milligram flat dose there, even in patients with severe renal impairment.
I think what we hear from physicians and is a concern about using Gattex in patients with moderate to severe renal impairment, even though you can use the dose adjustment, there are concerns about using it in renally impaired patients. And we think that the data that we presented at Aspen shows that apraglutide is going to be suitable without a dose adjustment across the full range of patients with SBS-IF.
Patrick Dolezal
Great. Thanks for taking the questions.
Operator
[Operator Instructions] Our next question coming from the line of Tiago Fauth with Credit Suisse. Your line is open.
Tiago Fauth
Hey, thanks for taking the question. So perhaps a potential differentiation and commercial question. So, I understand that it’s hard to prospectively assess what the impact you can have in the CIC patient population, but given that they do have lower baseline PS volumes, how important is it to establish a relative reduction versus number of days where they don’t have to take parenteral support therapy? And the reason I asked that is basically how may that actually end up looking in terms of claims in light of potential commercial scenario where you could have Gattex generics available. So just trying to understand how much of that CIC differentiation could be a key selling point relative to the better dosing regimen? Thank you.
Luca Santarelli
Okay. So, I guess let’s part this question. The first part is have do you — how do we describe benefit in CIC considering that volume is an absolute — is a bit perhaps less relevant. Okay, let me just say that I agree that it — number one, it is important to differentiate therapeutic objective and outcomes and benefits between these two autonomical [ph] subtypes. That is exactly the basis of our study. We believe there is a different — difference in the therapeutic objective and how benefit is described among these two subtypes.
In the CIC, as you correctly stated, the volume reduction its — they have a volume infusion there is approximately 30% to 40% less on average, if you look across large data sets. And so, the main goal in this population is to establish greater evidence of enteral autonomy. And that’s been a goal of our program and our study design. And that is basically — from the reduction of dependency of parenteral support by having fewer days of infusion a week, all the way to elimination of the need for the infusion, which is described as full enteral autonomy. And that means you remove the dwelling catheter, you remove the consequences and the risk of the sepsis risk associated with that.
So, for this population, there is a big opportunity to establish a path towards reduction of dependency in parenteral support, which is not a mere expression in volume or more in terms of enteral autonomy. That’s why we have stratified a study to conduct further analysis — secondary analysis into two subgroups, and in CIC, we also are running these patients up to 12 months, because we know that the effects of a GLP-2 can accrue for a period longer than 6 months, especially in the CIC. And we are doing that with the objective of demonstrating some of these patients can add a significant amount of days off, and in some cases achieve full enteral autonomy. So that’s the answer to the first question.
The second question was about I think it was about generic Gattex and what do we think about that? First of all, we do not know when and if there will be a generic Gattex from the U.S. Why this possibility [ph] is scheduled to expire in the middle of next year? There is no — there are no disclosure of [indiscernible] approvals of any generics to the [indiscernible] mechanism at this point. And then, even if a generic comes to market, it will still be a best like Gattex with all of its limitations, and we believe that apraglutide with a significant differentiator profile will make Gattex obsolete.
So, to [indiscernible] these conclusions, we actually conducted extensive payer research, and I actually would like our Chief Commercial Officer Kevin Harris, to tell you about this research we conducted. Kevin?
Kevin Harris
Yes, thanks, Luca. We’ve had significant engagement with payers over the past 2 years not only exploring this question, but how to appropriately position apraglutide as a potential future standard of care. And we’ve got some very important insights from the payer community. First is that they validate the fact that a generic Gattex will still obviously have the same clinical profile as a branded product. And given the nature of GLP-2 treatment today, and the disease of SBS-IF that payers only believed one or two generics may in fact launch. And if they do launch, they would only launch at a modest discount to branded therapy, which today is about $43,000 a month in the U.S.
In further exploration with these payers, they very much acknowledged the unmet need that exists today for patients with SBS-IF, and they also appreciate the fact that there’s a very small budget impact that GLP-2 treatment today has in their plans. I think most importantly, when we show them our product profile, they really do see a private [indiscernible] as differentiated in delivering a stronger value proposition. In particular, they really value the extra data that we plan on delivering with regards to a privatized efficacy in both the stoma population and in the CIC population, particularly the enteral autonomy data is — I would say, of the greatest value to the payer community. And all of the feedback we’ve gotten from the payers essentially reinforce the fact that we believe Gattex will essentially become obsolete with the launch of apraglutide.
Tiago Fauth
Perfect. Thanks again for taking the question.
Operator
Thank you. And I’m showing now further questions at this time. I’ll turn the call back over to Luca Santarelli for any closing remarks.
Luca Santarelli
Thank you. And I want to thank everybody who has joined us today for our earnings call, and I’m looking forward to keeping everybody posted in the future on our progress. Have a good rest of the day.
Operator
Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation. You may now disconnect.
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