Zealand Pharma A/S

Hello and welcome to this Zeland Pharma Conference call. I would like to advise all participants that this call is being recorded. Thank you. I'd now like to welcome Anna Krasowska to begin the conference. Anna, over to you.

Thank you. Welcome and thank you for joining us today to discuss Zeland's interim results for the first quarter of 2023. With me today are the following members of Zeland's management team. Adam Stainsberg, President and Chief Executive Officer, Henrietta Wenneke, Chief Financial Officer, and David Kendall, Chief Medical Officer. You can find the related company announcement and interim report on our website at ZeelandPharma.com. As described on slide two, we will be making forward-looking statements that are subject to risks and uncertainties. With that, I will turn the call over to Adam Stainsberg, President and CEO. Adam?

Thank you, Anna, and thanks to everyone for joining today. I'll begin on slide three. We are now one year into my tenure as CEO at Sealand, and I'm very proud of what we have achieved. With a strong focus on R&D, we have successfully progressed our product candidates within both rare diseases and obesity. And despite the turbulent financial environment, we have significantly strengthen our balance sheet, and streamline operations. The strong momentum has continued into the first quarter of 2023. In our BCT portfolio, we achieved impressive clinical results in two P programs. We are very encouraged about the clinical outcome announced yesterday with Berengar Ingenheim for the dual gluagon GLP-1 receptor agonist BI456906. and excited about BI's regulatory interactions on phase three initiation. Our Amazin analog, CP8396, showed profound reductions in body weight after one week in the single ascending dose trial, and is now progressing well in the phase 1B multiple ascending dose trial. Importantly, we have also strengthened our balance sheet with the 1.5 billion Danish kroner from a direct issue in April, bringing on board a broad group of specialist investors. We now have a cash runway to mid-2026. Moving to slide four, we remain focused on our strategic objectives and our post-run exciting and catalyst-rich 2023. We are on track for two regulatory submissions in our rare disease programs, The first submission is expected here in the second quarter for dasyclurgan in babies and children with congenital hyperinsulinism or CHI. The second is for clopacritide in people living with short bowel syndrome and intestinal failure, expected in the second half of the year. We expect to see the strong momentum continuing with our obesity assets. including upcoming clinical data presentations and initiation and reporting of new clinical studies across the portfolio. Our strategy to pursue partnerships remains on track, and we will seek to continue to participate in the programs across the value chain where we can leverage our strengths and capabilities to maximize the value of each asset. Advancing to slide five, I will now turn over the call to our Chief Medical Officer, David Pendle, to discuss the recent top line results and our R&D pipeline.

David.

Thank you, Adam. Today, I will focus my remarks on the recent top line results from our obesity portfolio. But first, I would like to provide a brief update on our two rare disease programs where we continue to focus on plans for regulatory submission. Turning to slide six, we are on track to submit the NDA for daziglucagon in the management of CHI during this quarter. We believe that daziglucagon can be an important potential treatment approach to this rare and devastating disease, and this program represents a significant opportunity for Zealand to address a major unmet medical need for these children and their families. Please turn to slide seven. Shown here is a schematic of our EASE Phase III clinical program for glopaglutide, our long-acting GLP-2 analog that is being developed for the treatment of short bowel syndrome and intestinal failure. We recently presented the results from the EASE-1 pivotal trial at the Aspen and DDW scientific congresses, and these data were very well received. We've recently completed the interim data cuts of EASE-2 and EASE-3 long-term extension trials, as well as from the EASE-4 study assessing long-term effects of glopaglutide on intestinal fluid and energy uptake. And results from all of these studies will be included in our planned regulatory submission. We are currently planning for pre-NDA interactions with the FDA later in the summer, and we remain on track for a potential regulatory submission for glopaglutide in the second half of this year. Turning now to our obesity portfolio in slide eight, We are pleased to have a rich and differentiated pipeline of novel assets for the potential treatment of overweight and obesity. As many of you are aware, obesity is a complex disease that is amenable to pharmacologic treatments that target a number of unique metabolic pathways. We are applying two specific approaches at Zeeland, dual pharmacology to target two receptors with one peptide and potent and differentiated single receptor agonists that can be used alone or in combination with other peptides as flexible use, loose combinations, or co-formulations. The detail on slide 8 outlines our differentiated peptide obesity portfolio. Each peptide in our pipeline has been designed to target important and established neurohormonal pathways that are known to play important roles in the regulation of body weight, including hunger and food intake, energy expenditure, composition and satiety, any one of which plays an important role in achieving weight loss. Our therapeutic approach aims to one, achieve increased weight loss, and two, provide additional effects that address specific needs or comorbidities of obese and overweight individuals. Turning to clinical data, on slide nine, we summarize the very exciting top line phase two clinical results with BI 456906 announced yesterday. BI-456906 is a glucagon GLP-1 receptor dual agonist co-invented with Meringer-Ingelheim, being evaluated as a potential treatment for people with overweight and obesity. We are exceedingly pleased with the clinical outcomes reported, which demonstrate up to 14.9% weight loss from baseline at week 46, based on the analysis of the planned maintenance dose or assigned dose with a safety and tolerability profile consistent with other incretin-based therapies. Importantly, this primary endpoint was based on the dose assigned at randomization, which was modifiable during dose escalation, and assessed efficacy based on that assigned dose, regardless of whether the planned dose was achieved during the final week, 26 weeks of study. Along with our colleagues at Beringer Ingelheim, we are excited to share the full phase two results from this dose finding study, including an analysis evaluating efficacy based on the actual maintenance dose used during the final 26 weeks, which indicate even greater weight loss. These data will be presented in their entirety at the upcoming American Diabetes Association scientific sessions to be held in late June in San Diego, California. On slide 10, we provide a summary of our novel long-acting amylin agonist. The islet hormone amylin is well known to play an important metabolic role and is a validated target for the potential treatment of obesity. Amylin treatment results in weight loss by reducing food intake and increasing satiety, and amylin is also known to restore leptin sensitivity, which may contribute to the maintenance of weight loss. In late March, we announced positive top-line results from our Phase Ia single ascending dose trial, of our long-acting amylin analog, ZP8396, or 8396. Healthy participants with a mean BMI of 25.8 were treated with a single dose of either subcutaneous 8396 or placebo across seven dose cohorts. Those individuals treated with 8396 had dose-dependent reductions in mean body weight of up to 4.2% from baseline, while placebo-treated individuals had a mean body weight increase of 0.6%. The plasma half-life of AD396 was 230 hours, which supports once-weekly dose administration, and treatment was assessed to be well-tolerated in this study, and detailed results of this trial will also be presented at the upcoming American Diabetes Association scientific sessions. In the second half of 2023, we expect to provide an update on the six-week portion of the multiple ascending dose trial with 8396, a study that is currently ongoing. Our focus is also on the planned initiation of the 16-week portion of this Phase 1b trial, in which we aim to evaluate higher doses than those used in the single ascending dose and the initial six-week multiple ascending dose studies. and we will also include individuals with overweight and obesity in this trial. We believe amylin agonism can play an important role both as a standalone treatment for obesity, serving individuals who may not tolerate or adequately respond to current GLP-1-based therapies, and amylin as a non-incretin hormone can be used in combination with other incretin-based treatments to provide additional weight loss. As we have previously shared, ZP8396 is specifically designed to allow for either co-formulation or co-administration with other peptide-based therapies. In closing and turning to slide 11, I also want to provide a brief update on dapiglutide, our first-in-class dual GLP1-GLP2 receptor agonist, a novel peptide that leverages the effects of a potent GLP1 agonist with the effects of GLP2. We are excited to explore the potential of this asset to not only achieve substantial weight loss, but also target low-grade inflammation through improved intestinal barrier function. We recently initiated an investigator-led clinical study to assess these mechanisms. We also expect to initiate a 13-week dose titration phase 1b study in individuals with overweight and obesity in the second half of 2023. We are both encouraged and extremely excited by the recent data readouts and the strong momentum across our development pipeline in rare diseases and obesity, and we look forward to providing additional updates as we advance our programs through 2023. I would now like to turn the call over to our Chief Financial Officer, Henrietta Benecke, to review our first quarter financial results for 2023. Henrietta?

Thanks, David, and hello, everyone. Let's move to slide 12 and the income statement. Revenue for the first quarter of 2023 was 14 million DKK, mainly driven by the license and development agreement with Novo Nordisk for Stigalok. The operating expenses for the periods were 182 million Danish crowns, driven by the progression of the late-days rare disease assets and the obesity programs. The R&D spend is slightly below Q1 last year due to timing of clinical activities. administrative expenses as well as sales and marketing expenses are however significantly below Q1 last year following the restructuring in March 2022. Net financial items for the period resulted in a loss of 27 million EKK by the loan agreement with Oberland and the partnership agreement with Beta Bionics. Let's move to slide 13 and the cash position. As of March 31, 2023, cash, cash equivalent, and marketable securities were approximately 1 billion Danish crowns. In April and May, we have taken significant action to strengthen Zealand's balance sheet. Firstly, in April, we successfully raised gross proceeds of 1.5 billion DKK from a direct issue and private placement of new shares. Secondly, in May, we fully repaid the loan certificates with Oberland Capital. The true cash effect of the final repayment will be a net outflow of 77 million U.S. dollars, and with this, the loan agreement Oberland is fully terminated. Thirdly, the repayment of the obligation with Oberland is refinanced through a new 350 million BKK revolving credit facility provided by Danske Bank and expected near-term upcoming milestones from existing partners. With these actions, Siemens now holds a much stronger balance sheet and a cut runway to mid-26. This will allow us to continue to invest in progressing our rich RMD pipeline. Let's move to slide 14 and our financial guidance. Our guidance is unchanged, and we continue to guide for net operating expenses of between 800 to 900 million Danish crowns in 2023. We will, as Adam said, also engage in partnership discussions this year in line with our strategy. However, we do not provide guidance on revenue anticipating from existing and new license and partnership agreements due to the uncertainty related to timing and wealth at the size of such revenue. That said, we do expect to receive milestone payments from existing partners in the near term.

And with that, I will turn the call back to Adam.

Thank you, Henriette. These first months of 2023 were exceptional for Sealand Pharma. And in closing, I would like to thank all our employees for their dedicated work towards achieving our strategic priorities. Likewise, we appreciate our partners for the strong collaboration and our current and new shareholders for the continued support and trust. Finally, I would like to express my sincere gratitude to those who are participating in our clinical studies. Thank you all. I will now turn over to the operator for questions.

At this time, I would like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad will pause for just a moment to compile the Q&A roster. Your first question comes from the line of Charlie of Morgan Stanley. Your line is open.

Hi, Charlie from Morgan Stanley. Thanks for taking my questions. So firstly, please could you provide any context around how the weight loss curves were trending in the Phase II study at 46 weeks? Do you think there is any more weight loss to go? And secondly, please could you provide an update on your discussions for the desiglucogon partners in CHI as you approach filing? Thanks very much.

Thank you, Charlie.

First of all, on the BI collaboration for GluAgon GLP-1, we cannot share more data before ADA. As we have communicated, we look very much forward to the conference and to discuss the data at that time. I would say if you look at other incutin-based therapies, then, of course, you can expect additional weight loss with time. That has been seen with all other incutin-based therapies. But we cannot discuss the specific data in more details, except, as David said before, that we are highly encouraged with what we have seen so far. On the DASIC-Logon CHI partnering discussions, we are Where we want to be, as we have communicated, our plan has all the time been to get the NDA package completed and ready for submission, and then start engaging in confidential discussions with potential commercial partners. So those are progressing as planned right now, and we also expect to open data room in the near term. and after then engage in more specific discussions. So things are progressing well and according to plan there.

Thank you. Thanks.

Your next question comes from the line of Michael Novak of Nadia. Your line is open.

Thanks a lot. It's Michael Novak from Nadia. Also a couple of questions. Maybe just to give us a bit of a feeling around how your investments are. are being done in R&D. How much are you actually putting into BCT this year and what is sort of the plans going forward? Because it's obvious that probably to invest in order to also gain more data and also try to do deals at some point in time for some of the early assets. And then secondly, on the pigletite, the GLP-1, GLP-2, can you talk about sort of the ratio between GLP-1 and GLP-2 You gave us the ratio on the BI-45 for GLP-1 versus glucagon. Maybe it would just be nice for us also to get the ratio around GLP-1, GLP-2. Thank you very much.

Thank you, Michael. I will just shortly answer your second question first, and then I'll hand over to Henrik. We have not released the specific ratio that we will provide at a coming scientific conference. We cannot comment in details on it, but I can highlight that our approach for these dual-acting peptides has been to make sure that they are biased towards activity on the GLP-1 receptor to make sure that we harvest the known benefits of GLP-1, and then just adding a little bit of additional pharmacology, just as we did with the VI compound. So you will have to wait with further data and specific data for this compound until a conference. It's the same concept we are applying as we did with the gluobon CLD1. Henrietta, will you take the other?

Hey, Michael, thanks for your question. So clearly we are investing heavily in obesity, and we are putting all investments into it to progress our obesity assets. Clearly, at this stage, as we are progressing towards MDAs for rare disease assays, these are also driving a lot of the costs you see we are burning currently. But clearly, as we file these, we will also, in the future, invest significantly more into our BCG assays as they progress. But clearly, everything we can put behind them, we do at the moment.

Okay. Great. Thank you very much. Thank you, Abs.

Your next question comes from the line of Jasper of Carnage Investment Bank. Your line is open.

Yes, thank you so much. Firstly, on your GIP assets, can you just provide some thoughts on this program, given what we saw with Novo's phase two data on SEMA-GIP, which didn't show any benefits on HBNC and weight versus SEMA loans. So just update the thoughts and whether or not you see this as impacting potential interest in this asset. Then secondly, on the BI data, I understand you cannot come into the detail, but perhaps it's just conceptually, why didn't all patients in the treatment arm reach maintenance dose in the 46-week study? So just to understand why the potential reasons for that, because I would assume that there's plenty of time for it. And then I have to follow up. Thank you.

Thank you. Yes, I was just and then I'll hand over to David for further comments. On the GIP, I want to mention that we have to bear in mind that all molecules are different. So, and therefore, we are still excited about our GIP molecule when we evaluate our preclinical evidence. And we don't have more insights into the NOVA program than what was released a few days back. And there could be specific reasons why they decide to prioritize differently in their pipeline. We have confidence in our molecule based on the preclinical data, but as we have also said, the clinical evidence for GIP as such remains to be established. And then, again, on the BI program, we cannot comment too much more, but I will leave it to David to both provide further comments on GIP and also if we can provide more nuance into the BI study. But it is really up for BI to provide these data at ADA, so we have to be a little bit mindful of that. David?

Yeah, thank you, Adam. And Jesper, thanks. GIP, obviously, we, like you, saw these decisions from Novo on one of their programs. Interestingly, as I think you know, they're continuing another program on the oral side with a combination of GLP-1 and GIP. As Adam said, we are quite pleased with our GIP agonist, based on the non-clinical data, which we presented in some detail at last year's Obesity Week meetings. And given the complexities now of GIP, transeptide, presumably carrying an agonist component in that molecule, the Amgen asset, an antagonist to GIP, I think there is likely much to be learned about the pharmacology of GIP. And clearly, based on those data from Lilly and Amgen and our own non-clinical data, we believe that GIP still has a very important potential role as an adjunct to other incretin and non-incretin-based therapies. But obviously, we're looking very closely at what data will be made available from the NOVA program to make decisions on our own. On the BI asset, as Adam said, we are... both mindful of and respectful of the embargo that the American Diabetes Association has placed. So granular detail on that program and the protocol can't be provided. But suffice it to say that Phase 2B is most importantly dose ranging, dose finding activity to ensure that we have an understanding of both the dosing and the titration scheme. And in this program, like many others, there was an opportunity for the investigators to modify the titration during the active titration scheme. The details of this will be outlined in the full numbers of subjects in, you know, what is essentially an intention to treat versus per protocol populations. We're excited to share at the upcoming scientific session. So without preempting that presentation that's the detail maybe an example is you know if someone had potentially tolerability issues that would give the investigators discretion in this and other phase two dose ranging studies to alter that titration scheme so that we have a better understanding to inform the full phase three program once those decisions are made

Okay, perfect. Yeah. Just one additional question on clopaclotide for me. So just perhaps you can put some additional comments on the note in your report about additional patients weaning off parental support, as well as whether or not these long-term extensive studies, what you've seen so far, that's more confident on the potential with clopaclotide.

Yeah, I'm happy to start, Jesper. And yeah. And Adam, if you have additional comments, I'll turn it back to you. But yeah, Certainly, you know, we're excited by having at least our initial look at the data readouts from the long-term extension. Both trials are ongoing. We've made the interim data cuts in both extension trials, and I'll just summarize by saying we're both very pleased, and the results are consistent, and a continued clinical effect is certainly being observed. Again, without preempting all of the full data sets, the issues of internal autonomy and continued reductions in PS. Those results are certainly very encouraging, and we think continue to add strength to the results of these one and additional safety exposure, obviously, which is important for the ultimate regulatory submission. Adam, any additional comments from you?

No, thanks, David. Thank you so much. Thank you. No, it's fine. Thank you. Thanks.

Your next question comes from the line of Peter Wilford of Jefferies. Your line is open.

Hi, thanks. I've got four very quick ones. Firstly, and sorry if I'm being stupid about this, but just coming back to the 906 maintenance versus actual. And I'm not asking for the data, but just so I can understand. Are we saying then that the planned maintenance dose is basically a protocol analysis so those people that didn't make it to the dose they were assigned are not included? whereas the actual maintenance dose is an ITT, so patients are included regardless of what dose they got to in that arm. So actually, some patients in the ITT analysis would be on a lower dose than was originally planned, but actually you're getting more weight loss when you do the ITT analysis, including those patients. Is that right? Secondly then, sorry, go ahead.

Thank you, Peter. I'll just follow up on David's note, and then we really have to be mindful of how the data is embargoed. But I think what is important to understand is the key element is that when you design these Phase II studies, of course, you can design them just to try to achieve the most weight loss that you want, or you can design them to best inform the decision-making for how to design Phase III. And then there are, of course, different ways to evaluate these data sets. And the data that we have released here that came out yesterday are from the patients based on the groups that they were randomized into. And in order to, you can say, following the dosing titration period, the first 20 weeks, investigators were allowed not to fully get up to the highest dose. And you can say the data that will come later at ADA is an analysis of those patients who actually was put up to the highest dose and then maintained on that for the remainder 26 weeks of the study. And of course, when you do phase three studies, you will design it a little bit different, these kind of things. I mean, you will not... key to fix those after 20 weeks and so on. So we are extremely encouraged by the data and we look very much forward to share them, but I really think we need the full data set to understand the details more.

Yeah, sorry, I got it. I meant to say the RAM before. So what we're saying is when you say the actual maintenance, what we're saying is the

The per protocol, in other words, the people actually did get... These are patients who reached the high... These are patients who were dosed up to the dose that they were randomized to.

Yeah, yeah, got it. Okay, fine. Okay, and then just secondly then, just on the NASH study, am I right in saying we're still anticipating NASH data later this year, year for 906?

Yeah, so the NASH... I'm happy to... Yeah, go ahead.

Yes, please take that, David, on the NASH.

Yeah, so the NASH phase two study, Peter, is fully enrolled and the data continue to be accumulated. So we await future data readouts when the last patient last visit and obviously the database is locked. So the obesity study that will be presented at ADA is that it was specifically designed to assess weight management in overweight and obese individuals. So the NASH study is forthcoming and ongoing, fully randomized, and we look forward to those results upcoming.

That's great.

Sorry. No, BI is guiding that they expect to complete the study this year, and then we don't know when it will be reported, but likely early next year. Got it.

Okay. And then just so I understand, on the financials, there's two very quick ones. Firstly, the income booked from NOVO in the revenue line, the $13 million DKK, is that all a straight royalty income, or is some of that $13 million? money Novo's paying for drug or something else for the residual. Just trying to understand how we should think about that going forward. And then just on the revolver, I'm curious, have you actually pulled down the $350 million revolver in May to pay the Oberland? Or is that just a facility that's available to you? I guess, given your cash balance, it doesn't seem immediately obvious necessarily why you'd pull on the revolver now. given, you know, 2.5 billion of Danish kroner available to the raise. Thank you.

Yes, thank you, Peter. I'm ready here. Let me comment on that. So the NOVO is a split of royalties and other activities we are conducting together with NOVO. So that would be a split, you could say, hitting the top line there. In regards to the revolving credit facility, you're right. We are not growing it down at the moment, but it's available to us, which I think is an important point. And I think it is a testament that we can actually establish a revolving credit facility at this point in time. And of course, the terms are significantly different from what we had on the previous facility we had in place.

That's great. Sorry, can you give us any sort of idea of, because obviously Novo is probably, well, probably never going to report Zegalog. So could you give us some sort of idea, I mean, what proportion is royalty? I guess I'm just curious, you know, when we think about 2Q, 3Q, 4Q, I mean, how should we think about at all what you've booked in 1Q as in any way recurring, if you like? Is there any proportion or something you can give for royalty to help us? Thank you.

Yeah, of course, we cannot comment on the specific details here, but I think, of course, it is a mix, and you're right. At the moment, the level is where it is, but it is a mix, so we cannot comment on the details of the contracts and how much is booked. You could say there is royalties and how much is other activities we are conducting. But you know, we are progressing towards the filing in Europe, and that's, of course, also included in the numbers, the activities that are conducted under that agreement.

And Peter, maybe just for me to follow up, I think compared to all of our other activities in the pipeline, both in rare disease and obesity, at least near term, we do not see this as being very material numbers for Sina and Pharma, but it's an important agreement and it's an important product for the patients, we believe, but it's not a very important material and we would not expect that to change significantly near term.

That's great. Thank you.

Your next question comes from the line of Rajan Sharma of Goldman Sachs. Your line is open.

Sorry, the connection is... Hello, can you hear me?

Rajan, sorry, the connection is really bad right now.

Just give us one second. Sure. And try again. Can you try again now?

Sure, is that better?

Yeah, it works now.

It works now. Okay, perfect. Thanks for taking my question. So first one on Amelin. Just could you help us think about what your expectations are for the MAD data in the second half of the year? Are you looking for weight reductions in line with what we saw in the single ascending dose? And then just on that asset, and you kind of talked about amylin and potential for combinations, when might you think about combination trials for your amylin agonist? And then just one on the GLP-1 glucagon co-agonist. What are you thinking about acceptable levels of GI-related AEs? I think there were some comments in the media by your partner, BI, yesterday that talked about the AE profile being in line with what we've seen with other commercial and late-stage obesity therapies. Could you just help us think about that? Thanks.

So I will thank you for the questions. On the amylin, I mean, I think we should not speculate too much because data is always data and the study is ongoing. But it's fair, and David, you can comment more on this in a minute, but it's fair to say that, as David also mentioned, it's a two-part study, the multiple ascending dose first, a six-week study, and then moving on to a 16-week study. So I would say the focus for us with the six-week study is to serve as a bridge towards getting the 16-week study started where we also have higher doses. But of course, you can say we would anticipate weight loss also in the six-week study since we observed after only one dose, and after one week, 4.2% weight loss in the single ascending dose study. But David, you can comment more on that, on the BI collaboration on side effects. I think we will stick with the note that BI put out, and I think we agree very much to it. Guilty ones are known for its solubility issues, which can also be managed by titration to a large extent. And I think with how BI positioned this, this is also our view. And then the specific data is, sorry for that, but it's again ADA. David, any comments or further elaborations?

Yeah, I think that just adds some flavor to the Amalyn question, Rajan. I think qualitatively, given what we saw in single-listing dose, we would certainly anticipate, even in the MAD Part 1, as we describe it, the six-week study, to hypothesize that they would be results that are qualitatively similar. To Adam's point, the second component of that, which is longer duration, including individuals who are overweight and obese, and titrating to higher doses, again, to inform phase two planning, we hope will give us a much broader brush of both the clinical response and the dosing regimen that we may be applying in future studies. So I don't want to get ahead of ourselves and speculate on the actual numbers. As regards combination trials, as you know, the regulatory path is somewhat sophisticated. So our near-term plans are to take this forward as a standalone asset to better understand its individual contribution. But obviously there's an opportunity, particularly with other approved assets for the management of obesity on the market to assess these in combination in later phase trials. So those are considerations, but the focus on the near term is for the monotherapy assessment And to Adam's point, I think we've seen both with higher-dose triseptide, higher-dose semaglutide, sort of the broad brush of what happens at GI side effects as you have more potent or higher exposure to GLP-1 agonism. And I'll stick with the BI comments as well, that the results we have seen and will report in just a few weeks are certainly consistent with those.

Perfect. Thank you.

Again, if you would like to ask a question, press the star, then the number one on your telephone keypad. There are no further questions at this time. I'd like to turn the call back over to Adam.

I don't know if you can hear us. I think we lost connection again a little bit.

If you can, then we would like to thank you all for attending and for your questions today. And we look very much forward to connecting on future announcements and updates. Thank you all.

Over to you, Ray.

This concludes today's conference call. You may now disconnect.

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Welcome and thank you for joining us today to discuss Zeeland's interim results for the first quarter of 2023. With me today are the following members of Zeeland's management team. Adam Stainsberg, President and Chief Executive Officer, Henrietta Renica, Chief Financial Officer, and David Kendall, Chief Medical Officer. You can find the related company announcement and interim report on our website at zeelandpharma.com. As described on slide two, we will be making forward-looking statements that are subject to risks and uncertainties. With that, I will turn the call over to Adam Sainsbach, President and CEO. Adam?

Thank you, Anna, and thanks to everyone for joining today. I'll begin on slide three. We are now one year into my tenure as CEO at Sealand, and I'm very proud of what we have achieved. With a strong focus on R&D, we have successfully progressed our product candidates within both rare diseases and obesity. And despite the turbulent financial environment, we have significantly strengthened our balance sheet and streamlined operations. The strong momentum has continued into the first quarter of 2023. In our obesity portfolio, we achieved impressive clinical results in two key programs. We are very encouraged about the clinical outcome announced yesterday with Brian Engelheim for the dual gluagon GLP-1 receptor agonist BI456906, and excited about BI's regulatory interactions on phase three initiation. Our amylin analog, CP8396, showed profound reductions in body weight after one week in the single ascending dose trial. and is now progressing well in the phase 1B multiple ascending dose trials. Importantly, we have also strengthened our balance sheet with the 1.5 billion Danish kroner from a direct issue in April, bringing on board a broad group of specialist investors. We now have a cash runway to mid-2026.

Moving to slide four, we remain focused on our strategic objectives

and are poised for an exciting and catalyst-rich 2023. We are on track for two regulatory submissions in our rare disease programs. The first submission is expected here in the second quarter for dasyluogon in babies and children with congenital hyperinsulinism, or CHI. The second is for clopacritide in people living with short bowel syndrome and intestinal failure, expected in the second half of the year. We expect to see the strong momentum continuing with our BTT assets, including upcoming clinical data presentations and initiation and reporting of new clinical studies across the portfolio. Our strategy to pursue partnerships remains on track, and we will seek to continue to participate in the programs across the value chain where we can leverage our strengths and capabilities to maximize the value of each asset. Advancing to slide five, I will now turn over the call to our chief medical officer, David Kendall, to discuss the recent top line results and our R&D pipeline.

David.

Thank you, Adam. Today, I will focus my remarks on the recent top line results from our obesity portfolio. But first, I would like to provide a brief update on our two rare disease programs where we continue to focus on plans for regulatory submission. Turning to slide six, we are on track to submit the NDA for daziglucagon in the management of CHI during this quarter. We believe that daziglucagon can be an important potential treatment approach to this rare and devastating disease, and this program represents a significant opportunity for Zealand to address a major unmet medical need for these children and their families. Please turn to slide seven. Shown here is a schematic of our EASE Phase III clinical program for glopaglutide, our long-acting GLP-2 analog that is being developed for the treatment of short bowel syndrome and intestinal failure. We recently presented the results from the EASE-1 pivotal trial at the Aspen and DDW scientific congresses, and these data were very well received. We've recently completed the interim data cuts of EASE-2 and EASE-3 long-term extension trials, as well as from the EASE-4 study assessing long-term effects of glopaglutide on intestinal fluid and energy uptake. And results from all of these studies will be included in our planned regulatory submission. We are currently planning for pre-NDA interactions with the FDA later in the summer, and we remain on track for a potential regulatory submission for glopaglutide in the second half of this year. Turning now to our obesity portfolio in slide eight, We are pleased to have a rich and differentiated pipeline of novel assets for the potential treatment of overweight and obesity. As many of you are aware, obesity is a complex disease that is amenable to pharmacologic treatments that target a number of unique metabolic pathways. We are applying two specific approaches at Zeeland, dual pharmacology to target two receptors with one peptide and potent and differentiated single receptor agonists that can be used alone or in combination with other peptides as flexible use, loose combinations, or co-formulations. The detail on slide 8 outlines our differentiated peptide obesity portfolio. Each peptide in our pipeline has been designed to target important and established neurohormonal pathways that are known to play important roles in the regulation of body weight, including hunger and food intake, energy expenditure, composition and satiety, any one of which plays an important role in achieving weight loss. Our therapeutic approach aims to one, achieve increased weight loss, and two, provide additional effects that address specific needs or comorbidities of obese and overweight individuals. Turning to clinical data, on slide nine, we summarize the very exciting top line phase two clinical results with BBI 456906 announced yesterday. BI-456906 is a glucagon GLP-1 receptor dual agonist co-invented with Meringer-Ingelheim, being evaluated as a potential treatment for people with overweight and obesity. We are exceedingly pleased with the clinical outcomes reported, which demonstrate up to 14.9% weight loss from baseline at week 46, based on the analysis of the planned maintenance dose or assigned dose with a safety and tolerability profile consistent with other incretin-based therapies. Importantly, this primary endpoint was based on the dose assigned at randomization, which was modifiable during dose escalation, and assessed efficacy based on that assigned dose regardless of whether the planned dose was achieved during the final week of 26 weeks of study. Along with our colleagues at Beringer Ingelheim, we are excited to share the full phase two results from this dose finding study, including an analysis evaluating efficacy based on the actual maintenance dose used during the final 26 weeks, which indicate even greater weight loss. These data will be presented in their entirety at the upcoming American Diabetes Association scientific sessions to be held in late June in San Diego, California. On slide 10, we provide a summary of our novel long-acting amylin agonist. The islet hormone amylin is well known to play an important metabolic role and is a validated target for the potential treatment of obesity. Amylin treatment results in weight loss by reducing food intake and increasing satiety, and amylin is also known to restore leptin sensitivity, which may contribute to the maintenance of weight loss. In late March, we announced positive top-line results from our Phase Ia single ascending dose trial, of our long-acting amylin analog, ZP8396, or 8396. Healthy participants with a mean BMI of 25.8 were treated with a single dose of either subcutaneous 8396 or placebo across seven dose cohorts. Those individuals treated with 8396 had dose-dependent reductions in mean body weight of up to 4.2% from baseline, while placebo-treated individuals had a mean body weight increase of 0.6%. The plasma half-life of AD396 was 230 hours, which supports once-weekly dose administration, and treatment was assessed to be well-tolerated in this study, and detailed results of this trial will also be presented at the upcoming American Diabetes Association scientific sessions. In the second half of 2023, we expect to provide an update on the six-week portion of the multiple ascending dose trial with 8396, a study that is currently ongoing. Our focus is also on the planned initiation of the 16-week portion of this Phase 1b trial, in which we aim to evaluate higher doses than those used in the single ascending dose and the initial six-week multiple ascending dose studies. and we will also include individuals with overweight and obesity in this trial. We believe amylin agonism can play an important role both as a standalone treatment for obesity, serving individuals who may not tolerate or adequately respond to current GLP-1 based therapies, and amylin as a non-incretin hormone can be used in combination with other incretin based treatments to provide additional weight loss. As we have previously shared, ZP8396 is specifically designed to allow for either co-formulation or co-administration with other peptide-based therapies. In closing and turning to slide 11, I also want to provide a brief update on dapiglutide, our first in class dual GLP-1, GLP-2 receptor agonist, a novel peptide that leverages the effects of a potent GLP-1 agonist with the effects of GLP-2. We are excited to explore the potential of this asset to not only achieve substantial weight loss, but also target low-grade inflammation through improved intestinal barrier function. We recently initiated an investigator-led clinical study to assess these mechanisms. We also expect to initiate a 13-week dose titration phase 1b study in individuals with overweight and obesity in the second half of 2023. We are both encouraged and extremely excited by the recent data readouts and the strong momentum across our development pipeline in rare diseases and obesity. And we look forward to providing additional updates as we advance our programs through 2023. I would now like to turn the call over to our Chief Financial Officer, Henrietta Benecke, to review our first quarter financial results for 2023. Henrietta?

Thanks, David. And hello, everyone. Let's move to slide 12 and the income statement. Revenue for the first quarter of 2023 was 14 million DKK, mainly driven by the license and development agreement with Novo Nordisk for Stigalok. The operating expenses for the periods were 182 million Danish crowns, driven by the progression of the late-days rare disease assets and the obesity programs. The R&D spend is slightly below Q1 last year due to timing of clinical activities. administrative expenses as well as sales and marketing expenses are however significantly below Q1 last year following the restructuring in March 2022. Net financial items for the period resulted in a loss of 27 million EKK by the loan agreement overland and the partnership agreement with Beta Bionics. Let's move to slide 13 and the cash position. As of March 31, 2023, cash, cash equivalents, and marketable securities were approximately 1 billion Danish crowns. In April and May, we have taken significant action to straighten Zealand's balance sheet. Firstly, in April, we successfully raised gross proceeds of 1.5 billion DKK from a direct issue and private placement of new shares. Secondly, in May, we fully repaid the loan facilities with Oberland Capital. The true cash effect of the final repayment will be a net outflow of 77 million U.S. dollars, and with this, the loan agreement Oberland is fully terminated. Thirdly, the repayment of the obligation with Oberland is refinanced through a new 350 million BKK revolving credit facility provided by Danske Bank and expected near-term upcoming milestones from existing partners. With these actions, SEVA now holds a much stronger balance sheet and a cost runway to mid-26. This will allow us to continue to invest in progressing our rich RMD pipeline. Let's move to slide 14 and our financial guidance. Our guidance is unchanged, and we continue to guide for net operating expenses of between 800 to 900 million Danish crowns in 2023. We will, as Adam said, also engage in partnership discussions this year in line with our strategy. However, we do not provide guidance on revenue anticipating from existing and new license and partnership agreements due to the uncertainty related to timing and build at the size of such revenue. That said, we do expect to receive milestone payments from existing partners in the near term.

And with that, I will turn the call back to Adam.

Thank you, Henriette.

These first months of 2023 were exceptional for Sealand Pharma. And in closing, I would like to thank all our employees for their dedicated work towards achieving our strategic priorities. Likewise, we appreciate our partners for the strong collaboration and our current and new shareholders for the continued support and trust. Finally, I would like to express my sincere gratitude to those who are participating in our clinical studies. Thank you all. I will now turn over to the operator for questions.

At this time, I would like to remind everyone in order to ask a question, press star then the number one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. Your first question comes from the line of Charlie of Morgan Stanley. Your line is open.

Hi, Charlie from Morgan Stanley. Thanks for taking my questions. So firstly, please could you provide any context around how the weight loss curves were trending in the phase two study at 46 weeks? Do you think there is any more weight loss to go? And secondly, please could you provide an update on your discussions for the desiglucogon partners in CHI as you approach filing? Thanks very much.

Thank you, Charlie.

First of all, on the BI collaboration for GLU-1 GLP-1, we cannot share more data before ADA. As we have communicated, we look very much forward to the conference and to discuss the data at that time. I would say if you look at other incutin-based therapies, then, of course, you can expect additional weight loss with time. That has been seen with all other incutin-based therapies. But we cannot discuss the specific data in more details, except, as David said before, that we are highly encouraged with what we have seen so far. On the DASIC-Logon-CHI partnering discussions, we are Where we want to be, as we have communicated, our plan has all the time been to get the NDA package completed and ready for submission, and then start engaging in confidential discussions with potential commercial partners. So those are progressing as planned right now, and we also expect to open data room in the near term. and after then engage in more specific discussions.

So things are progressing well and according to plan there. Thank you. Thanks.

Your next question comes from the line of Michael Novak of Nadia. Your line is open.

Thanks a lot. It's Michael Novak from Nadia. Also a couple of questions. Maybe just to give us just a bit of feeling around how your investments are. are being done in R&D. How much are you actually putting into BCT this year and what are the plans going forward? Because it's obvious that you probably need to invest in order to also gain more data and also try to do deals at some point in time for some of the earlier assets. And then secondly, on the pigletite, the GLP-1, GLP-2, can you talk about the ratio between GLP-1 and GLP-2? You gave us the ratio on the BI45 for GLP-1 versus glucagon. Maybe it would just be nice for us also to get the ratio around GLP-1, GLP-2. Thank you very much.

Thank you, Michael. I will just shortly answer your second question first, and then I'll hand over to Henriette. We have not released the specific ratio that we will provide at a coming scientific conference. We cannot comment in details on it, but I can highlight that our approach for these dual-acting peptides has been to make sure that they are biased towards activity on the GFD1 receptor to make sure that we harvest the known benefits of GFD1, and then just adding a little bit of additional pharmacology, just as we did with the BI compound. So you will have to wait with further data and specific data for this compound until a conference. It's the same concept we are applying as we did with the lubricant. Will you take the other?

Hey, Michael, thanks for the question. So clearly we are investing heavily in obesity, and we are putting all investments into it to progress our obesity assets. Clearly, at this stage, as we are progressing towards MDAs for rare disease assays, these are also driving a lot of the costs you see we are burning currently. But clearly, as we file these, we will also, in the future, invest significantly more into our BCG assays as they progress. But clearly, everything we can put behind them, we do at the moment.

Okay. Great. Thank you very much. Thank you.

Your next question comes from the line of Jasper of Carnage Investment Bank. Your line is open.

Yes, thank you so much. Firstly, on your GIP assets, can you just provide some thoughts on this program, given what we saw with Novo's phase two data on SEMA-GIP, which didn't show any benefits on HBNC and weight versus SEMA loans. So just update the thoughts and whether or not you see this as impacting potential interest in this asset. Then secondly, on the BI data, I understand you cannot come into the detail, but perhaps it's just conceptually, why didn't all patients in the treatment arm reach maintenance dose in the 46-week study? So just to understand why the potential reasons for that, because I would assume that there's plenty of time for it. And then I have to follow up. Thank you.

Thank you. Yes, I was just and then I'll hand over to David for further comments. On the GIP, I want to mention that we have to bear in mind that all molecules are different, and therefore we are still excited about our GIP molecule when we evaluate our preclinical evidence. And we don't have more insights into the NOVA program than what was released a few days back. And there could be specific reasons why they decide to prioritize differently in their pipeline. We have confidence in our molecule based on the preclinical data, but as we have also said, the clinical evidence for GIP as such remains to be established. And then, again, on the BI program, we cannot comment too much more, but I will leave it to David to both provide further comments on GIP and also if we can provide more nuance into the BI study. But it is really up for BI to provide these data at ADA, so we have to be a little bit mindful of that. David?

Yeah, thank you, Adam. And Jesper, thanks. GIP, obviously, we, like you, saw these decisions from Novo on one of their programs. Interestingly, as I think you know, they're continuing another program on the oral side with a combination of GLP-1 and GIP. As Adam said, we are quite pleased with our GIP agonist, based on the non-clinical data, which we presented in some detail at last year's Obesity Week meetings. And given the complexities now of GIP, transeptide presumably carrying an agonist component in that molecule, the amgen asset, an antagonist to GIP, I think there is likely much to be learned about the pharmacology of GIP. And clearly, based on those data from Lilly and Amgen and our own non-clinical data, we believe that GIP still has a very important potential role as an adjunct to other incretin and non-incretin-based therapies. But obviously, we're looking very closely at what data will be made available from the NOVA program to make decisions on our own. On the BI asset, as Adam said, we are... both mindful of and respectful of the embargo that the American Diabetes Association has placed. So granular detail on that program and the protocol can't be provided, but suffice it to say that phase 2B is most importantly dose ranging, dose finding activity to ensure that we have an understanding of both the dosing and the titration scheme. And in this program, like many others, there was an opportunity for the investigators to modify the titration during the active titration scheme. The details of this will be outlined in the full numbers of subjects in, you know, what is essentially an intention to treat versus per protocol populations. We're excited to share at the upcoming scientific session. So without preempting that presentation that's the detail maybe an example is you know if someone had potentially tolerability issues that would give the investigators discretion in this and other phase two dose ranging studies to alter that titration scheme so that we have a better understanding to inform the full phase three program once those decisions are made

Okay, perfect, yeah. Just one additional question on clopaclotide for me. So just perhaps you can put some additional comments on the note in your report about additional patients weaning off parental support, as well as whether or not these long-term extensive studies, what you've seen so far, that's more confident on the potential with clopaclotide.

Yeah, I'm happy to start, Jesper, and yeah, and Adam, if you have additional comments, I'll turn it back to you, but... Certainly, you know, we're excited by having at least our initial look at the data readouts from the long-term extension. Both trials are ongoing. We've made the interim data cuts in both extension trials. And I'll just summarize by saying we're both very pleased, and the results are consistent, and a continued clinical effect is certainly being observed. Again, without preempting all of the full data sets, the issues of internal autonomy and continued reductions in PS. Those results are certainly very encouraging, and we think continue to add strength to the results of these one and additional safety exposure, obviously, which is important for the ultimate regulatory submission.

Adam, any additional comments from you? No, thanks, David. Thank you so much. Thank you. No, it's fine. Thank you. Thanks.

Your next question comes from the line of Peter Wilford of Jefferies. Your line is open.

Hi, thanks. I've got four very quick ones. Firstly, and sorry if I'm being stupid about this, but just coming back to the 906 maintenance versus actual. And I'm not asking for the data, but just so I can understand. We're saying then that the planned maintenance dose is basically a protocol analysis. So those people that didn't make it to the dose they were assigned are not included. whereas the actual maintenance dose is an ITT, so patients are included regardless of what dose they got to in that arm. So actually, some patients in the ITT analysis would be on a lower dose than was originally planned, but actually you're getting more weight loss when you do the ITT analysis, including those patients. Is that right? Secondly then, sorry, go on. Sorry, go ahead. Thank you, Peter.

I'll just follow up on David's note, and then we really have to be mindful of how the data is embargoed, but I think what is important to understand is the key element is that when you design these Phase II studies, of course, you can design them just to try to achieve the most weight loss that you want, or you can design them to best inform the decision-making for how to design Phase III. And then there are, of course, different ways to evaluate these data sets. And the data that we have released here that came out yesterday are from the patients based on the groups that they were randomized into. And in order to, you can say, following the dosing titration period, the first 20 weeks, investigators were allowed not to fully get up to the highest dose. And you can say the data that will come later at ADA is an analysis of those patients who actually was put up to the highest dose and then maintained on that for the remainder 26 weeks of the study. And of course, when you do phase three studies, you will design it a little bit different, these kind of things. I mean, you will not... keep a fix those after 20 weeks and so on so we are extremely encouraged by the data and we look very much forward to share them but but i really think we need the full data set to to understand the details more yeah sorry sorry i got it i meant to say the ram before so yeah so what we're saying is is your when you say the actual maintenance does what we're saying is the

The per protocol, in other words, the people actually did get... These are patients who reached the height.

These are patients who were dosed up to the dose that they were randomized to.

Yeah, yeah, got it. Okay, fine. Okay, and then just secondly then, just on the NASH study, am I right in saying we're still anticipating NASH data later this year, year for 906?

Yeah, so the NASH... I'm happy to... Yeah, go ahead.

Yes, please take that, David, on the NASH.

Yeah, so the NASH phase two study, Peter, is fully enrolled and the data continue to be accumulated. So we await future data readouts when the last patient last visit and obviously the database is locked. So the obesity study that will be presented at ADA is that it was specifically designed to assess weight management in overweight and obese individuals. So the NASH study is forthcoming and ongoing, fully randomized, and we look forward to those results upcoming.

That's great.

Sorry. No, BI is guiding that they expect to complete the study this year, and then we don't know when it will be reported, but likely early next year.

Got it. Okay. And then just so I understand, on the financials, there's two very quick ones. Firstly, the income booked from NOVO in the revenue line, the $13 million DKK, is that all a straight royalty income, or is some of that $13 million? money Novo is paying for drug or something else for the residual. Just trying to understand how we should think about that going forward. And then just on the revolver, I'm curious, have you actually pulled down the $350 million revolver in May to pay the Oberland? Or is that just a facility that's available to you? I guess, given your cash balance, it doesn't seem immediately obvious necessarily why you'd pull on the revolver now. given, you know, 2.5 billion of Danish kroner available to the raise. Thank you.

Yes, thank you, Peter. I'm ready here. Let me comment on that. So the NOVO is a split of royalties and other activities we are conducting together with NOVO. So that would be a split, you could say, hitting the top line there. In regards to the revolving credit facility, you're right. We are not drawing it down at the moment, but it's available to us, which I think is an important point. And I think it is a testament that we can actually establish a revolving credit facility at this point in time. And of course, the terms are significantly different from what we had on the previous facility we had in place.

That's great. Sorry, can you give us any sort of idea of, because obviously Novo is probably, well, probably never going to report Zegalog. So could you give us some sort of idea, I mean, what proportion is royalty? I guess I'm just curious, you know, when we think about 2Q, 3Q, 4Q, I mean, how should we think about at all what you've booked in 1Q as in any way recurring, if you like? Is there any proportion or something you can give for royalty to help us? Thank you.

Yeah, of course, we cannot comment on the specific details here, but I think, of course, it is a mix, and you're right. At the moment, the level is where it is, but it is a mix, so we cannot comment on the details of the contracts and how much is booked. You could say there is royalties and how much is other activities we are conducting. But, you know, we are progressing towards the filing in Europe, and that's, of course, also included in the numbers, the activities that are conducted under that agreement.

And, Peter, maybe just for me to follow up, I think compared to all of our other activities in the pipeline, both in rare disease and obesity, at least near term, we do not see this as being very material numbers for senile trauma, but it's an important agreement and it's an important product for the patients, we believe, but it's not a very important material, and we would not expect that to change significantly near term.

That's great. Thank you.

Your next question comes from the line of Rajan Sharma of Goldman Sachs.

Your line is open.

Hello, can you hear me?

Rajan, sorry, the connection is really bad right now.

Just give us one second and try again. Can you try again now?

Sure, is that better? Yeah, it works now. Okay, perfect. Thanks for taking my question. So first one on Amelin. Just could you help us think about what your expectations are for the MAD data in the second half of the year? Are you looking for weight reductions in line with what we saw in the single ascending dose? And then just on that asset, and you talked about amylin and potential for combinations, when might you think about combination trials for your amylin agonist? And then just one on the GLP-1 glucagon co-agonist. What are you thinking about acceptable levels of GI-related AEs? I think there were some comments in the media by your partner, BI, yesterday that talked about the AE profile being in line with what we've seen with other commercial and late-stage obesity therapies. Could you just help us think about that? Thanks.

So I will thank you for the questions. On the amylin, I mean, I think we should not speculate too much because data is always data and the study is ongoing. But it's fair, and David, you can comment more on this in a minute, but it's fair to say that, as David also mentioned, it's a two-part study, the multiple ascending dose first, a six-week study, and then moving on to a 16-week study. So I would say the focus for us with the six-week study is to serve as a bridge towards getting the 16-week study started where we also have higher doses. But of course, you can say we would anticipate weight loss also in the six-week study since we observed after only one dose, and after one week, 4.2% weight loss in the single ascending dose study. But David, you can comment more on that, on the BI collaboration on side effects. I think we will stick with the note that BI put out, and I think we agree very much to it. Guilty ones are known for its solubility issues, which can also be managed by titration to a large extent. And I think with how BI positioned this, this is also our view. And then the specific data is, sorry for that, but it's again ADA. David, any comments or further elaborations?

Yeah, I think that just adds some flavor to the Amelin question, Rajan. I think qualitatively, given what we saw in single listening dose, we would certainly anticipate, even in the MAD part one, as we describe it, the six-week study, to hypothesize that they would be results that are qualitatively similar. To Adam's point, the second component of that, which is longer duration, including individuals who are overweight and obese, and titrating to higher doses, again, to inform phase two planning, we hope will give us a much broader brush of both the clinical response and the dosing regimen that we may be applying in future studies. So I don't want to get ahead of ourselves and speculate on the actual numbers. As regards combination trials, as you know, the regulatory path is somewhat sophisticated. So our near term plans are to take this forward as a standalone asset to better understand its individual contribution, but obviously there's an opportunity particularly with other approved assets for the management of obesity on the market to assess these in combination in later phase trials. So those are considerations, but the focus on the near term is for the monotherapy assessment. And to Adam's point, I think we've seen both with higher dose triseptide, higher dose semaglutide, sort of the broad brush of what happens at GI side effects as you have more potent or higher exposure to GLP-1 agonism. And I'll stick with the BI comments as well, that the results we have seen and will report in just a few weeks are certainly consistent with those.

Perfect. Thank you.

Thanks, Rajan.

Again, if you would like to ask a question, press star, then the number one on your telephone keypad. There are no further questions at this time. I'd like to turn the call back over to Adam.

Yeah, I don't know if you can hear us. I think we lost connection again a little bit.

But if you can, then we would like to thank you all for attending and for your questions today. And we look very much forward to connecting on future announcements and updates. Thank you all.