Q4 2022 Zealand Pharma A/S Earnings Call
Speaker 1: For you.
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Speaker 2: Good day and thank you for standing by. Welcome to the Zealand farmer results for the Fully Year 2022 Conference call. At this time all participants are in a listen only mode. After the speech presentation there will be a question and answer session.
Speaker 2: To ask a question during the session, you will need to press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 and 1 again.
Speaker 2: Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Anna Krasauska, VP of Investor Relations. Please go ahead.
Speaker 3: Thank you, operator. Welcome and thank you for joining us today to discuss Vee
Speaker 3: Adam Steinsber, President and Chief Executive Officer, Hymnalja Divinica, Chief Financial Officer, and David Kendall, Chief Medical Officer. You can find the related company announcement and annual report on our website at sealandpharma.com.
Speaker 3: As described on slide 2, we will be making forward-looking statements that are subject to risks and uncertainties. With that, I will turn the call over to Adam Sainsbury. Adam?
Speaker 4: Thank you, Ana, and thanks to everyone for joining today. I'll begin on slide three.
Speaker 4: 2022 was a transformative year for SeaLand and I'm proud of the progress our team has made since announcing the change in strategy to prioritize investments in peptide therapeutics R&D.
Speaker 4: We achieved key milestones across our clinical pipeline. In positive phase 3 results for both our assets target...
Speaker 4: targeting rare diseases, pathetic work on newborns and children with congenital hyperintimidism, and, for example, aircraft sickness with short- broadcast symptoms.
Speaker 4: We also advanced our portfolio of peptides targeting obesity.
Speaker 4: Following our decision to scale back commercial operations, we executed two partnerships for our marketed products.
Speaker 4: We showed the Vigo insulin delivery device to mankind cooperation.
Speaker 4: And we entered into a partnership with Novo Nordisk to commercialize CIGALOG.
Speaker 4: Finally, despite the challenging financial markets, we were able to strengthen our balance sheet through equity raises and extend our cash runway into mid-24.
Speaker 4: Continuing this momentum, 2033 looks to be a very exciting year for CMAN. Turning to slide 4.
Speaker 4: We have three key strategic objectives aimed at maximizing the value potential of our portfolio.
Speaker 4: Our first objective is to progress our rare disease as the static organ and the pachycyte towards regulatory submission.
Speaker 4: Our second objective is to advance our BGC portfolio.
Speaker 4: For the Blue GeoD1 Duo Accommoded CI 4559.06, Burhamai is planning to share the results of the phase 2 obesity trial with the scientific community in the coming months.
Speaker 4: Wernher has also informed us that in parallel they are engaging with health authorities to discuss plans for phase 3 for people living with an overweight and obesity.
Speaker 4: Regarding our wholly owned assets in our BECT, we expect to present data from the Amelian Phase 1 program during the year and initiate new clinical studies with all three assets.
Speaker 4: Finally, our third key objective is to engage in partnership discussions in alignment with our change in strategy. As we evaluate future partnerships, we will seek to continue to participate in the programs across the value chain, leveraging our strengths and capabilities to maximize the value of the asset.
Speaker 4: In addition to these three key objectives, we also focus on activities that support our programs in type 1 diabetes management. This includes submitting a marketing application application to the European Medical Agency for C-GALOG.
Speaker 4: which we are responsible for under the global agreement with Nobel Prize winners.
Speaker 4: I would like to spend a few minutes on our basic UoI program in children with congenital hyperinsulinism or CHI as we are approaching the NDA submission in the first half of this year. And we believe it represents significant opportunity for CNM to address a major unmet medical need for children and their families.
Speaker 4: Moving to slide five.
Speaker 4: CHI is a rare disease that affects babies and children. A defect in the pancreatic beta-dose results in an overproduction of insulin, leading to frequent episodes of severe hypoglycemia that may result in brain damage.
Speaker 4: Care for patient with CHI is complex.
Speaker 4: and more than half maybe sub-optimally treated the current therapies.
Speaker 4: We have completed a phase III program, demonstrating the clinical potential of dantagliram administered as a continuous subcutaneous infusion via a viable pump.
Speaker 4: If approved, we expect to utilize the decade infusion pump to provide basic robot to patients.
Speaker 4: Shown on slide 6, we estimate that there are up to 800 children with diffuse CHI that may be a digital potassium-1 treatment in the US.
Speaker 4: Most of these children are treated closely followed by pediatric endocrinologists in a few centers of excellence.
Speaker 4: To the right of the slide we present examples of other products targeting ultra rare diseases with high clinical burdens that come up premium pricing in the US.
Speaker 4: And if approved, we do believe that that _____ has the potential to provide comparable clinical value, thus also representing a significant opportunity for sealant.
Speaker 4: Advancing to slide seven, I will now turn over the call to our Chief Medical Officer, David Kendall, to discuss the rest of the R
Speaker 5: Thank you, Adam. Today I will focus my remarks on our obesity portfolio. But first, I would like to provide a brief update on glopaglutide, our long-acting GLP2 analog that is being developed for the treatment of short bowel syndrome and intestinal failure.
Speaker 5: Thank you, Adam. Today I will focus my remarks on our obesity portfolio. But first, I would like to provide a brief update on glopaglutide, our long-acting GLP2 analog that is being developed for the treatment of short bowel syndrome and intestinal failure. Please turn to slide 8.
Speaker 5: As many of you know, in September of 2022, we reported positive top-line data from the EES-1 Phase III trial, which demonstrated that the opaglit diet treatments, given quite sweetly, when comparatively severe significantly reduced parental support volume required in individuals living with SBS and intestinal failure. In addition, we observed that approximately one in eight patients treated with SBS.
Speaker 5: scientific congresses in the coming months, including data on the response in specific subgroups.
Speaker 5: A total of 96 patients who completed EASE 1 enrolled in EASE 2, the first of two long-term safety and efficacy extensions studies.
Speaker 5: Interim data from these extension trials, as well as from the EASE-4 study, assessing long-term effects on globaglitide on intestinal fluid and energy uptake, will all be a part of the regulatory package for globaglitide. We had previously anticipated interim results from EASE-2 before the end of 2022, but we were not able to find any.
Speaker 5: include data from patients who are on placebo in Ease 1 and thus this will allow us to hopefully expand our understanding of the potential for glopagglotide to reduce or eliminate the need for parenteral support as we observed in Ease 1. As such the interim results from Ease 2
Speaker 5: 3, and full results of EASE 4 are now anticipated in the first half of this year. Importantly, extending the follow-up period for EASE 2 and 3 will not impact the timing for a potential regulatory submission.
Speaker 5: which we anticipate in the second half of 2023. Advancing to slide nine and focusing on our obesity portfolio haha.
Speaker 5: There is little doubt that obesity represents one of the most significant healthcare challenges of our time, and we are excited to have a rich and differentiated pipeline of novel assets for the potential treatment of obesity.
Speaker 5: Obesity is a complex disease that can be treated pharmacologically by targeting a number of unique metabolic pathways.
Speaker 5: While single modality therapies have shown significant effect on body weight, it is expected that dual or triple hormonal treatments will be necessary to achieve even greater degrees of weight loss, comparable to that seen following bariatric surgery.
Speaker 5: We are using 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 loose combinations or in co-formulations.
Speaker 5: specific approaches at Zealand. 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 loose combinations or in co-formulations. Please turn to slide 10.
Speaker 5: In this figure, we present a representation of our Dicor-Ancheyed and peptide molecules targeting obesity.
Speaker 5: Each peptide in our portfolio has been designed to target important neurohormonal pathways that are important in the regulation of body weight, including food intake, energy expenditure, food composition, and satiety. Any one of which can play important roles in achieving weight loss. Our therapeutic approach aims one.
Speaker 5: to achieve increased weight loss and two to provide additional effects to address the 15s or co-orbidities of obese or overweight individuals.
Speaker 5: Our novel dual hormone candidates are designed with GLP-1 receptor agonism as a foundation to provide weight loss through reduced food intake and delayed gastric emptying and to offer the potential to improve glycemic control while adding agonism to a second receptor for complementary effects.
Speaker 5: With each of these molecules, we are targeting weight loss that can exceed that observed for GLP1 receptor agonism alone, with the potential based on non-clinical and clinical observations to date to be on par with other dual hormone candidates currently in development.
Speaker 5: Turning our attention to BI456906, an asset co-invested with Werner Ingelheim, where the additional effects of glucagon receptor agonism are designed to complement GLP-1 agonism and are postulated to stimulate energy expenditure and improve the trafficking effect with the potential to further improve weight loss.
Speaker 5: and target disorders of the earth facts.
Speaker 5: BI456906 is in active clinical development with our Barringer-Engelheim partners for the management of obesity and NASH.
Speaker 5: In 2022, varying encouraging data on both Lycena control and weight loss in patients with type 2 diabetes were reported following only six weeks of treatment.
Speaker 5: We very much look forward to having BI share the results from the 46-week phase 2 trial of BI 456906 in overweight and a weak individual at a scientific Congress in the coming months.
Speaker 5: Dappy Glutide is a first-in-class dual GLP1 GLP2 receptor agonist leveraging the effects of GLP2 agonism, a peptide monon that is post-acreated with GLP1 following yields.
Speaker 5: The rationale for driving use of DAPI glue tide is the potential to provide weight loss through potent GLP1 receptor agonist activity combined with the known effects of GLP2 agonism on intestinal barrier function.
Speaker 5: It is postulated that improvements in intestinal barrier function can improve gut function and target the low grade inflammation that is associated with syndromes of obesity. We are actively investigating a number of these mechanisms through an investigator-led clinical study due to start in the coming days.
Speaker 5: We also believe, based on data from clinical studies, the GLP2 receptor agonism can also contribute to improve tolerability of the associative GLP1 agonist. And in closing, we note that our portfolio also includes two single receptor agonists.
Speaker 5: The island hormone hamilum is known to play an important metabolic role in the validated target for the potential treatment of obesity.
Amylin treatment results in weight loss by reducing food intake by increasing satiety and amylin is known to restore leptin sensitivity which may contribute more lasting weight loss effects.
We believe amylin agonism can play an important role both as a standalone treatment for obesity, serving patients who may not tolerate or adequately respond to 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.
Zeeland's model long acting anteline analog is specifically designed to allow for once weekly administration and for co-formulation or co-administration with other peptide-based therapies.
We are currently advancing our MLN analog, ZP8396, through Phase 1 multiple ascending dose studies and plans to share clinical data from this program this year. Finally, we are planning to bring our unique standalone GIP receptor-agonist clinical studies in the second half of 2023.
We are both excited and encouraged by the strong momentum across our development pipeline and rare diseases and obesity and look forward to providing additional updates as we advance our programs in 2023. I will now turn the call over to our CFO Henrietta Venicki to review the full-year financial results for 2022.
Thanks David and hello everyone. Let's move to slide 11 and the income segment.
Riven your purchase from the 2, but 100,000,000,000 DKK, green body development agreements, the deletion and the partnership agreements made in Q2, 2020, get no unordered.
He even received an off-con claimant of 25 million people came from Europe .
The other right-hand expenses for the period of 941 million DKK, within our values for transition to. This is largely above last year, and comparing the continued population.
To increase the student's article question on research and development activities, especially our NAFES based training programs.
The sale for marketing expenses decreased compared to last year, following their amount of restrictions in March 2022.
Other operating items increased due to reduction in class related to continued operation and cost related to the US NASA D-Lacing in September 2022.
Net financial items for the period which are in the launch of $35 million DTK compared to $25 million DTK for the same period in 2021. Each cost after marriage during the wedding loan agreements with Oberland.
At the top of the land structure, all income and expenses related to commercial efforts related to ego and signal are accounts for a discontinued operation.
Net results, published in Discontinuous Brace in 2022, was a loss of $237 million PKK.
Let's move on to slide 12 and the cash position. In 2022 we were able to strengthen our balance sheet with gross proceeds worth more than 1 billion DKK despite very challenging financial markets.
We also pay down half of the specificity with open lines and make significant investments in procuring our pipeline.
A year in 2022, CAST, CAST, CRELIMAN and myical securities, for approximately 1.2 billion BKK.
With this, we have a cash runway to mid-2024, which allows us to continue investment in progressing our on-be pipeline in 2023.
Talking about 2023, let's move on to side 13 and the financial targets for the year.
As Adam said, 20-23, looks to be a very exciting year for CINAN.
We will invest in composing our red key assets towards regulatory submission in 2023, while at the same time investing in our BCT portfolio. Consequently, in 2023, we guide net per net operating expenses of the 300 to 900 million German BKK. Thank you.
This is someone lower than recent years expense living and do reflect the destruction initiatives implemented last year.
In 2022-3, we will also engage in partnerships as Adam mentioned, and line-up that I will change this strategy. However, we will not provide guidance on revenue and tigipated from existing and new license on partnership agreements due to uncertainty related to the timing and the relative size of such revenue.
In 2020-23 we will also engage in partnership discussions as Adam mentioned, a line that I will change with strategy. However we will not provide guidance on revenue anticipated from existence and new license and partnership agreements due to uncertainty related to the timing as well as the size of such revenue. With that I will turn the call back to Adam.
Thank you, Henry. 2022 was a year of significant contribution to our company.
And through our strong clinical progress and successful partner year goals, we are well positioned to achieve our strategic priorities in 2023 and beyond.
We look forward to NDA sub-needs for all strategies, programs, and significant properties for clinical programs targeting obesity, like striving to be the world's best type drug discovery and development company.
Thank you all and I will now turn it over to the operator for questions.
Thank you. As a reminder to ask a question, you will need to press 1 and 1 on your telephone and wait for your name to be announced.
to withdraw your question, please press star one and one again.
question, please press star one and one again. We will take our first question.
Our first question comes from the line of Thomas Bowers from Thanks. Thanks. Go ahead.
Yes, thank you very much. A couple of questions from my side. So just kick off working over here with the BI 45. So you comment in the report that the BI is currently engaging with health authorities to discuss the phase 3 plan. So could you maybe just add?
a bit of collar on the environment made by PI recently and also the reason for you to now be able to communicate what seems like quite material increase certainty that this candidate will go into Phase 3. And second, it just on this being, you will say there was advocate here. So that Phase 3 planning
you have raised your peak set is the expectation due to, of course, all the drug pricing strategy and then after some pay-as-you-back. But so where does this actually lead to regarding the outliers in the partner situation? I sort of sent a change of mind here.
So can you maybe just elaborate what's your plan A and play Plan B so to say? So anything that could first of all materialize pre- and DA or pre-approval and then and also if you actually end up going alone here is this actually something that maybe could even also have some impact on your op-hack guidance for 23?
our clear ambition to have a commercial partner for CHI. And as we have close and NDA submission in this third half year and we will hope to see a part review round of six to eight months with the FDA. It is of course important to have a partner on board this year and all to become to be fully ready to launch in the first time.
been clear that we wanted to get the NDF file in place before we truly activated these discussions because it is more simple to have a dialogue with multiple parties if you have the full data set in an NDA format.
So we feel very confident in this path and that is our our security. Having said that as we also shared and shared here in our to Pat remarks, when it is our ambition to play a role in these strategic partnerships, we're not just looking for strategic opportunities on paper, we actually do it is our ambition to continue to play a role but to collaborate with companies.
they are filled into our pouches so there should be no... no...
impact here. When considering our new ground tier, we won the BI 456906, now if you will, the burnout is developing.
We have been very clear for a long time and of course it's based on our own review of the early data that the product looks extremely strong and they have also communicated and based on feedback from from the owner that they have a lot of confidence in them in the molecule. You are right that now they are actually allowed us and informed us that through the both they stick to share the data in the coming months from the
that's going on in the program and also have towards the opportunity to move into phase 3. But as you know, I cannot comment further on these details because we have not seen the phase 2 data yet. And it is up to burn to...
to provide the further details to the program, but we send a lot of confidence in the program and also confidence towards the opportunities to move towards space-free. That's great. Yeah, thank you very much.
the third detail to the program, but we send a lot of confidence in the program and also confidence towards the opportunities to move towards space-free. That's great. Yeah. Thank you very much.
Thank you. We will take our next question. Your next question comes from the line of Brian Bolshin from Jeffries. He's going to have your line of open.
Hey, it's just it's Brian from Jeffies. Just a quick clarification on bi not only fixing obesity. Is there a potential milestone associated with the initiation of that phase three?
Hey, it's just it's Brian from Jeffies. Just a quick clarification on bi I know fixing obesity. Is there a potential milestone associated with the initiation of that phase three? Ciao
So thanks for that question, Brian . So we only guide on, you can say, outstanding milestones and RRCs, and we have around 350 million euros in outstanding milestones and high things to low-dose RRCs to the program. I think it's fair to assume that it's a critical pre-clinical deal that we made, and we have received a lot of significantly.
those will only come once we know them.
Good, thanks very much.
Thank you. We will take our next question.
Our next question comes from the line of Micronovid from Nordea. Please go ahead. Your line is open.
Thank you very much. So a couple of questions from ISAD as well. First on the pick the tide, would you expect that it's possible to have the initial results available sort of by year end 2023 or early 2024 from the
Investigators sponsor the Phase 2 trial. And secondly, on BI 456-I-06.
given sort of traditional timelines would then be fair to assume that
data will be out at ADA and secondly also that at that point in time Birmingham will have likely clarifications of the ongoing discussions regarding Phase 3 plans with the regulatory authorities. IE that they will also like to be to be a communicator around ADA.
whether it's a go or no go decision to start the phase three. It definitely sounds like a go decision, but we just need the firm announcement and the timing of that. And then lastly,
Maybe just sort of a, of course, a smaller question to SeaGalog. Now it's in the hands of Noble. We haven't seen any sort of notable traction thus far. When would you expect that we start to see something on SeaGalog? I know it's not a key drug for you guys, but still it would be nice to see that it gains some traction in the US. Thank you very much.
Thank you, Michael, for good questions. If I just start, I'm thinking about, we can say we handed this part over to Noan Rottis in the second half of last year. And of course, we would expect to see some traction coming into the year, once they get the hands are down. So, but as we have also over time said, it is not the most important.
part of our value or equity story to see that it was it's an incredibly important product for patients and we are extremely happy to see that it's in the hands of no one else but of course we would expect to see traction and also that the product start to provide some contributions to our revenue in the future and one of the activities that we are focused on this year is
So we could also potentially get the product into the European market. And the collaboration 906 and assumptions around when BI will make decisions and so on. I'm really sorry that I cannot make more comments. I think we have gone as fast as we can go right now in the commenting. As I said before we do.
On the Vatican side, we are just about to start the study, as David said, and maybe David you can share a little bit more light on what we intend to achieve here, but I think it's more likely early 2020. Yeah, Michael, thanks for the questions around Daphne. The investigator-led trial...
We have successfully navigated the requirements now in Europe for CTA's BTIS. And as I said, we anticipate the initiation of the first patient within the coming days. The timing of the final data availability of this quota to Adam's point is very likely to fall right around the change in years.
we would anticipate that in early 2024, we would have those data. And obviously we ourselves are planning progression to the dose ranging, integration study phase one B. So all of that is in...
play for this calendar year and we look forward to more comprehensive data availability from the investigator let trial in our own programs in the first part of next year.
Okay, great. Maybe I can just throw in one, there's no follow-up question to sort of the partnering preferences because you're getting phase one data for YAMLIN analog during the year, you're getting the pick the time data during sort of turn of the year or into early 2024.
What would be sort of the partnering preferences? Is it to do a potential larger strategic collaboration where you sort of also pair a player's smaller role or would you rather prefer to do individual partnering on these projects like the MLN Dept. Type and also the GIP?
That's a very good question, Michael and I would say we are open to both scenarios. I think the most important part for us is we believe, especially for the tree assets, the tree preparatory assets where we have all rights, we believe this represents a very very significant value of potential for this company and we are in a unique situation here. I think you know that open.
biopic companies find themselves in a situation where even though it's early clinical programs, they are quite mature when you compare across the industry to look outside, even in the world. And we know that it's a large farmer, a group of companies who normally expect to be in this space but they do not have the richness of the pipeline, who would expect so. We are in a very very unique situation and we also, as we have said today, fully committed.
to continue investing and putting all the effort into these programs as needed in the next couple of years. When we before we end up there is three, it would be very logical to have a partner on board. And I would say also of course it could also be logical to have a partner on board earlier for these programs because of the potential value they carry. But our purpose is perhaps not so much if it's one partner for all three assets or if it's
or even stuff we have in the pre-tinnacle of pipeline, or the individual partnerships, the most important part is that it's the right partnership. It's a 100% committed non-starm company, and we have the opportunity to continue to contribute. And thereby also retain more of the value of police programs because of the value potential we see with them.
That's great. Thank you very much. Thank you. Thank you. We will take our next question. Your next question comes from the line of Tsushima, Kronande from Van Lanchot. Please go ahead your line if open.
Yes, thank you for taking my question. So for the MNN analog single ascending and null descending dose data sets, it is coming out in H1 and H2 respectively. Can you provide some context on what we should expect in terms of number of subjects, metrics and biomarkers, and what is in your view key to show in the study? And also a second question on the partnerships. So could you further elaborate on your plans for Lepla?
Good, I have two slides. Where are the discussions now versus late last year and what do you look for in a partnership and what should we expect in terms of timing? Thank you. Thank you, I was dialing and I'm keeping my hand over to David. I partner shifts from the tactile type. It's a little bit of similar situation as we have with CHI. We really like to have all our data in place before we open our data room, but having said that we have...
multiple interested parties as with CHI and we have progressed dialogues but we do not anticipate to open up data rooms until we have all data and place. Basically it makes it too complicated if we have half big data stories. So that will give you a little bit of open idea on the timeline for that.
is as with CHI and we have progressed dialogues but we do not anticipate to open up data rooms until we have all data and trace. Basically it makes it too complicated if we have half big data stories. So that will give you a little bit of an idea on the timeline for that and I will say for the liver.
It's a little bit the same type of partnership as with CHI. Perhaps you can say, for people you need organizations who have a little bit stronger commercial footprints because it is going to be a competitive situation where as a CHI it's a more, it's a, it's a, we are going to be potentially the first that can introduce something for these patients. So there is enough just to have the radices infrastructure to support the virus get to the market. On the timelines and the data and studies on emulating because it is one of our key obedience, where I will ask David to just come a little bit on that. Yeah, thanks for the question. And yeah, phase one, as you well know, if not always the space for the most creative study designs, the 50-inch all our ability and ensuring we have...
adequate exposure to our amelanologue that will inform dosing for phase two is obviously key to those studies. But as we have reported, we've completed the single ascending dose study and those data. We believe will give us the first lens at the potential.
impacts on body weight, much as you may recall for our DAPI gluteide asset despite relatively short exposure. One gets an early perspective on the potential for its impact on body weight and phase one B will give us even greater insights into dosing, though, that escalation and longer exposure that will allow an even more
as to their clinical effect, even in the safety of tolerability and both finding studies.
Thank you. Thank you very much. We will take our next question. Your next question comes from the line of just burntly or so from Colorgie. Please go ahead. Your line is open.
Thank you so much. A few follow-up questions from my side. So firstly on partnership deal updates just to understand you guys here on the call. Is it still the base case to start partnership discussions on platylic type doing true or is that more Q3 now do to these they?
gathering of the full 24 week interim data on contact with time. So will you start the progress with structural partnership progress in Q3 now if that farts resume. Then on CHI, can you just confirm are you still in partnership discussions and would it in that case be farts resume potential deal during the second half?
discussions at several levels. Regarding moving to the daily on space and getting into the very details of discussions, we have, first of all, we are providing to have the data and faith. For CHI, that is going to be the case, as you know, very soon, because we are hopefully soon to submit the NDA. And also, we expect a fast review with the FDA. So the FHI partnership is our first priority this year.
because we expect to have a partner to launch with potentially already third half of next year. Another key priority for us is of course to once we have all the data and how engage in discussions in more data and data-based discussions on the packet time. Whether that's going to start in the second or third quarter, I think it's not something I can come into this pandemic. certainly notamps.
But it's, I can comment on our priorities and that is basically due to long timing that for CHI it's important for us to have a partner face before later because with later as you know we expect the 12 months, we have an only a submission in the second half so we have more time and then for obesity it's a little bit opportunistic to whether we just keep dialogues on goal. So that is my state of priorities and I hope that answers your question. Thank you. It's just a ball of then through this you CHI sales opportunity.
So based on your slides and you've also previously shown this, it indicates a 400 million total addressable market or more. Do you think that we underestimate this sales opportunity and based on the discussions you've had with partners so far, do these partners agree with this or is this just, you know, the theoretical sales potential and not what could be the base case?
Yeah, I would say we have not shared market research yet. So what we have done is we have we have a pretty good idea about As good as you can have for a rare to see to ask which really don't have any good treatments today How many patients would be available in the key centers and and then when we cook that down to say who are the ones of these patients who we truly could be candidates because they have insufficient resources to current ways of managing the patient then we get to a number of eight hundred and that is within the target population of the patients that we would hope to have in a potential label. Having said this.
Very often for for radities and other radities is once you start to have treatment opportunities available, you'll start to see public patients in centers and smaller clinics. So it could be a higher number, but this is another which we need to send around to the key centers and it doesn't even account for the European opportunity. So I would...
It's a number that we are pretty comfortable with, but I could also easily see that the number of digital patients would be higher once we start to, if we have a part that is available to patients. And then I would say another thing that we are looking into when it comes to to high-go insulinism is also if we should start to consider programs for adult patients because we think that's not opportunity to expand into those as well. So on the value of the trunency we have only so far decided to provide examples of comparable products which we have, which have longed into where the seeds are to where the seeds market. And we have not shared any specific market research on our program, but I would say if we provide sufficient clinical benefits which we...
and the initial impact you see in the heart rate with that asset if you can share that based on the 16 week diabetes data. And is this increase in heart rate a reason why you believe the I have likely started trials in obesity but potentially not in types of diabetes until further titration work has been done. I know a parallel here to what's going on with Lydys triple G agonist.
The second one on on on on Dapakalutide, can you help us understand how much further you're going to likely push the dose in your 13 week dose ascension study versus the the investigator led dream study. I'm just wondering which additional benefits you expect you might be able to see as you push up the dose both on the JLP1 and the JLP2 component. And then lastly on the Amelene analog 8396 two parts, have you seen any potential here in CKD? Other companies that are playing in a space of mention potential.
with the 906. Then I think I am very certain that the hardware observations in the time to start, it has nothing to do with current priorities regarding PVT and S. I think it has been the key focus for all the more than time. I think it's extremely encouraging to see the very good glucose control. The product also provides, but
And such diabetes management is more saturated today, and more treatment charges, whereas in a BGTN and NAS, that much, much bigger need can do another treatment. So that is the flow for them. And maybe just one more, and they do when I'm coming on the hardware observations. Because that's what I'm saying. Yeah, Mark, thanks for the question. And as you're probably well aware, virtually across the panel of potent G-O-P1 receptor agonist, and I've had exposure to a few of them over the years, particularly as the dose is pushed, that increase in heart rate is a known consequence of these long-acting G-O-P1 agonists. But obviously there are plenty of encouraging data on cardiovascular risk with these same agents.
dose escalation. Obviously the investigator-led study is in great part in the hands of that investigator and because many of the outcomes are mechanistic they have a somewhat different dose escalation and the maximal dose that we would anticipate will be slightly lower than that plan for our phase 1B.
So as with all of these GOP1-based therapies, it is really looking to achieve a balance between optimal dose exposure, the highest dose possible given its tolerabilities, but also having an understanding of what titration scheme will allow you to get there. So our efforts in Phase 1-B will be person-formist to assess the efficacy, but also to gain a clear understanding of what dose...
scheme, meaning titration, and maximal dose can be used in phase 2 and beyond. So I hope that to give you some clarification. Finally to Amel and the 8396, the combinations as I alluded to in my remarks, really this opens a number of possibilities. Our asset, as you know, is co-formulatable. We've presented non-clinical data co-formulations with the GOP1 receptor agonists with our DAPI glue tied, assets as a code administration. So really the opportunities to combine with any and all other Inkritten-based therapies on something we don't see likely with pigrilin type given now it is being.
assessed and likely brought forth for submission. But that free standing or loose combination opportunity, and ultimately if there is interest to co-formulation, possibility for fixed dose combos, really do exist based on what partners may be most interested. Your comment about the CKB, obviously at any weight loss age of the lower burden, fat, emily, body mass, and also can reduce blood pressure like we've seen with the SGTL. T2 inhibitors, the GF-1 receptor agonist. So yes, we are intrigued by that potential opportunity. But first and foremost, as we've said, our focus.
will be on affecting our AMO and Agonist in the obesity space. But these other value ads, if you will, will certainly be on our radar as we get into phase two in the arm. Thank you, David. And just going back to the hot rate increase if I'm missed. So with triple D and most due time, you're seeing up to 30 beast a minute, which you'll be on the system. And it's like six to seven beast a minute. Obviously it comes down with a triple G over time and most due time, but it's something that regulates as if I took some concerns around. I guess if you look at the out immune asset, you don't see increase in heart rate because the pharmacanetics. I just wondered with this BIS, what level of heart rate increase you've seen and whether from your your position, you think this is something that's going to be.
And for other years, we want to go around. We think it's actually more a question. If you have to give one involved, then you will get, you will observe the same pharmacology as has been seen with other years, if you don't have to want involved, then you might more see what you could expect from that to go around. So we think it will, yeah, it represents, it represents, click.
And maybe too bad, those escalating in order to get to, if you get to read out, and this is of course something as you also mentioned, then you get into the long, of some studies you can address this and titrate in a more sensible way. Yeah, and Mark, to add to that, you're right with the long acting agonists, particularly with the slower titration schemes that have ultimately been brought to market. If you remember back to Julie Booddye, Lily Strudelicity, and I was with Lily at the time, but these are public domain information.
that they actually, we actually had an adaptive Phase 2, 3 design that included both the Petrations scheme and included heart rate increases as part of that decision tree. Atoms point, both the total exposure to GLP1 and the rapidity with which you increase the GLP1 exposure can have significant impacts on heart rates. So it would not overread into particularly shorter-term studies that push the dose quickly. And obviously we'll have, we hope, the data from the UV City population with BI 456906 very soon to get a broader look at a much longer exposure in the 46-week study, which for us is obviously an important.
piece of data to understand the full 16.5-0.5. That's great. Thanks very much for the collect. Really appreciated. Thanks everyone. There seems to be no further questions. I would like to hand back for Krozen remarks. OK, but with that, we'd like to thank all the attendants for all the good questions. And we do very much forward to connecting us future announcements and updates. Have a great day. This concludes today's conference call. Thank you for participating. You may now disconnect.
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Welcome and thank you for joining us today to discuss Veline's full year results for 2022. With me are the following members of Veline's management team. Adam Stainsberg, President and Chief Executive Officer, Himalayan Ividika, Chief Financial Officer, and David Kendall, Chief Medical Officer. You can find the related company announcement and annual report on our web.
2022 was a transformative year for the United States, and I'm proud of the progress our team has made since announcing the change in strategy to prioritize investments in pet touch if you look on the.
Yet she is keen milestone across our clinical pipeline. Reporting positive, three results for both our assets targeting where the thesis, pathetic work on newborns and children with congenital hyperintervenism and for protect retarded people living with short bio symptoms. We also advanced our portfolio of peptides.
targeting of NECIT. Following our decision to scale back commercial operations, we executed two partnerships for our market of products. We sold the VGo Insulin delivery device to mankind for theVictory
And we end up into a partnership with Nor North to commercialize CIGARLUG. Finally, despite the challenging financial markets, we were able to strengthen our balance sheet through equity raises and extend our cash runway into mid-24.
Continuing in this momentum, 2023 looks to be a very exciting year for CNN. Turning to slide four, we have three key strategic objectives aimed at maximizing the value potential of our portfolio.
Our first objective is to progress our strategies as the basic logon and the packet size to work regulatory submission. Our second objective is to advance our BGT-4 forwarding. For the Blue GeoD1 dual-accompanied CI-45-69 and VI, Burma is planning to share the results of the phase 2 BGT-5 with the scientific community in the coming months.
Finally, our third key objective is to engage in partnership discussions in alignment with our change in strategy. As we evaluate future partnerships, we will seek to continue to participate in the programs across the value chain, leveraging our strengths and capabilities to maximize the value of the asset. In addition to these three key objectives, we are also focused on activities that support our programs.
operation in the first half of this year and we believe it represents significant opportunity for CNN to address a major unmet medical needs for children and their families. Moving to slide 5.
CHI is the rare disease that affects babies and children. A defect in the tank-ready feeder's throat results in an overproduction of insulin leading to frequent etymethose of severe hydroplotemia that may result in brain damage.
care for patients with CHI is complex, and more than half may be sub-optimally treated with current therapies. We've completed a phase 3 program, demonstrating the clinical potential of diagnostic organs administered as a continuous sub-continuous infusion via a viable pump. If approved, we expect to utilize the second infusion pump to provide diagnostic organs to patients.
Schoen's slide sticks re-estimate that there are also 800 children with the few CHI that may be a vehicle for vegetable ones treatment in the US. Most of these children are treated as closely followed by paediatric and the technology in the few centers of excellence. To the right of the slide we present examples of other products targeting ultra-redicities with high clinical burden that come out, premium pricing in the US.
And if a group we do believe that that is a global and has the potential to provide comparable clinical value, thus also representing a significant opportunity for Zealand. Advancing to slide seven, I will now turn over the call to our chief medical officer, David Kendall, to discuss the rest of the afternoon lifeline. David. Thank you, Adam. Today I will focus my remarks on our obesity portfolio. But first, I would like to provide a brief update on clinical paylifice, our long-acting GLP2 analog that is being developed for the treatment of Fort Biles syndrome and its testinal failure. Please turn to slide eight.
treated with glyph? in ease one successfully weaned off parental support within 24 weeks, achieving so-called the entral autonomy. While no placebo treated patients were able to achieve this entral autonomy, a feature we believe is differentiating concurrent treatments.
We look forward to presenting the results of EES-1 at upcoming scientific congresses in the coming months, including data on the response in specific subgroups. A total of 96 patients who completed EES-1 enrolled in EES-2, the first of two long-term safety and efficacy extensions vetting. In our data from these extension trials, as well as from the EES-1.
However, having the positive results of EES-1 in hand, we made a decision to extend the interim analysis to include 24-week data from all individuals enrolled into EES-2. This will include data from patients who are on placebo in EES-1 and thus, this will allow us to hopefully expand our understanding of the potential for the peptide to reduce or eliminate the need for parental support as we observe in EES-2.
Advancing to slide 9 and focusing on our obesity portfolio.
There is little doubt that obesity represents one of the most significant healthcare challenges of our time, and we are excited to have a rich and differentiated pipeline of novel assets for the potential treatment of obesity. Obesity is a complex disease that can be treated pharmacologically by targeting a number of unique metabolic pathways. While single-modality therapies have shown significant effect on body weight,
single receptor agonet that can be used alone or in combination with other peptides that loose combination or in co-formulations.
Please turn to slide 10. In this figure, we present a representation of our differentiated peptide molecules targeting obesity. Each peptide in our portfolio has been designed to target important neural hormonal pathways that are important in the regulation of body weight, including food intake, energy expenditure, food composition, and society.
any one of which can play important roles in achieving weight loss. Our therapeutic approach aims one to achieve increased weight loss in two to provide additional effects to address specific needs or co-orbities of obese or overweight individuals. Our novel dual hormone candidates are designed with GLT-1 receptor agonism as a foundation to provide weight loss through reduced food intake and delayed gas for emptying and to offer the potential to improve glycine control.
while adding agonism to a second receptor for complementary effects. With each of these molecules, we are targeting weight loss that can exceed that observed for GLP1 receptor agonism alone, with potential based on non-clinical and clinical observations to date to be on par with other dual hormone candidates currently in development. During our intention to BI 456906, an asset co-invented with Bernier-Ingelheim, where the additional effects of glucagon receptor agonism are designed to complement GLP1 agonism and are postulated to stimulate energy expenditure and improve the trafficking of facts.
in overweight and a reeth individual at a scientific Congress in the coming months.
Dappy Blue died as a first-in-class dual GLP1-GLP2 receptor agonist, leveraging the effects of GLP2 agonism, a peptide bone known that is co-secreted with GLP1 following meals.
The rationale for driving use of DAPI glue tide is the potential to provide weight loss through potent GLP1 receptor agonist activity combined with the known effects of GLP2 agonism on intestinal barrier function.
It is postulated that improvements in intestinal barrier function can improve gut function and target the low grade inflammation that is associated with syndromes of obesity. We are actively investigating a number of these mechanisms through an investigator-led clinical study due to start in the coming days.
We also believe, based on data from clinical studies, the GLP2 receptor agonism can also contribute to improve tolerability of the associated GLP1 agonist. And in closing, we note that our portfolio also includes two single receptor agonists.
The Ileformal and Hamillin is known to play an important metabolic role in the validated target for the potential treatment of obesity. Hamillin treatment results in weight loss by reducing food intake, by increasing satiety. And Hamillin is known to restore leptin sensitivity which makes contribute to more lasting weight loss effects. We believe Amal and Agony's can play an important role both in the standalone treatment for obesity, serving patients who may not tolerate or adequately respond to GLP one-day therapies. And Hamillin is a non-increasing hormone.
can be used in combination with other Inquitant-based treatments to provide additional weight loss. Zealands' novel Long Acting Amelan Analog is specifically designed to allow for once-weekly administration and for co-formulation or co-administration with other peptide-based therapies. We are currently advancing our Amelan Analog ZP-8396 through phase one multiple ascending those studies and plans to share clinical data from this program this year. Finally, we are planning to bring our unique standalone GIP receptor-agannus into clinical studies in the second half of the year.
by the development agreement with a lecture and the partnership agreement made in June 2022 with Northern Orange. He then received an off-con claim of 25 million DTC from NOAA.
The operating expenses for the period of 941 million DKK began our fadders for transition to 2. They could slide the above last year and compare it with continual growth. It increased the driven vertical portion of our research and development activities, especially our NAFTAs training for progress. The sales of marketing expenses decreased compared to last year.
following their land's restructure in March 2022. Other operating items increased due to restructuring costs related to continued operations and cost related to the US nest at sea listing in September 2022.
yet financial items for the period which was in the launch of $35 million DTK compared to $25 million DTK for the same period in 2021.
Each cost are primarily driven by the loan agreements with Oberland. As a result of the amount of destruction, all income and expenses related to commercial efforts related to vehicle and signal loss are accounts for a discontinued operation. Yet, results for these discontinued rates in 2022 was a loss of 237 million PKK.
Let's move on to slide 10, drop under cash position. In 2022, we were able to strengthen our balance sheet with gross proceed growth more than 1 billion DKKs, despite very challenging financial markets.
We also pay down half of the specificity with overland and make significant investments in procuring our pipeline. At year 2020-22, CAST-CAST relevance and mycological securities for a proffsim at the $1.2 billion KKE.
With this, we have a cast runway to Miss 2020 fall, which allows us to continue investment in progressing our on-be pipeline in 2023. Talking about 2023, let's move on to slide 13 and the financial values from year. As Adam said, 2023 looks to be a very exciting year for women.
We will invest in composing our rarest piece of assets towards regulatory submission in 2023, while at the same time investing in our BCT portfolio. Consequently, in 2023, we guide net-to-net operating expenses of between 800 to 900 million This is somewhat lower than recent years' expense living and do reflect the reduction so that external initiatives implemented last year.
In 2022, we will also engage in partnerships as Adam mentioned, and line up at our changes strategy. However, we will not provide guidance on revenue anticipated from existence and new license on partnership agreements due to uncertainty related to the timing and relative size of such revenue. And with that, I will turn the call back to Adam.
Thank you, Henry. 2022 was a year of significant distribution for our company. And through our strong clinical progress and successful partner years, we have well positioned to achieve our strategic priorities in 2023 and beyond.
We look forward to NDA sub-needs for all radiative programs and significant properties for clinical programs targeting obesity, like striving to be the most best peptide drug discovery and development company.
Thank you all and I will now turn it over to the operator for questions. Thank you as a reminder to ask a question. You will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will take our first question.
So just kick off working over here with the BI 45. So you comment in the report that the BI is currently engaging with health authorities to discuss the phase three plans. So could you maybe just add a bit of color on the advancements made by BI recently and also the reason for you to now be able to communicate what seems like.
quite material increase, certainty that this candidate will go into Phase 3. And secondly, just on this being, you would say, there was advocate here. So that Phase 3 planning comment you made, I guess that's of course related to obesity and not just interactions for type 2 diabetes obviously, just to rule out any misunderstandings. And then my last question related to CHI, so of course the partner situation. I noticed you have raised your...
and DAO or pre-approval and also if you actually end up going alone here is this actually something that maybe could even also have some impact on your OPEC guidance for 23. Yeah I think that was basically it. Thank you.
Thank you, Thomas, for your question. And I will start out and may hand it over also today at one point. But if we just start with CHI as a first thing, it is with the news for every we have. It is our clear ambition to have a commercial partner to CHI. And as we approach an NDA submission.
In this third half here and we hope to see a review round of six to eight months with the FDA. It is of course important to have a partner on board this year and all to become to be fully ready to launch in the third half of next year if we can continue to shoot those timelines. So it is clearly our plan A to have a partner and I as we also have shared we have.
have very good interactions and I'm making good progression on these discussions, but we've also been clear that we wanted to get the NDA file in place before we truly activated these discussions because it is more simple to have a dialogue with multiple parties if you have the full data set in an NDA format. So we feel very confident on this path and that is our our strategy. Having said that as we also shared and shared here in our paper marks, then it is our ambition to play a role in these strategic partner ships. We're not just looking for strategic opportunities on paper, we actually do, it is our ambition to continue to play a role but to collaborate with companies who have radicals commercial infrastructure in place so we will not have to build that meaning silencers to play a role there.
But of course that also depends on the discussions as they progress. And I would also say all the activities, commercial activities, this year for pre-launch activities, they are built into our purchase so there should be no impact here. When considering our Google GUN tier, the BI 455906 model, if you will, the third is developing. We have been very clear for a long time and of course it's based on our...
own review of the early data that the product looks extremely strong and they have also communicated and data feedback from from Verna that they have a lot of confidence in them in the molecule. You are right that now they are actually allowed and informed us that first of all they expect to share the data in the coming months from the obesity phase 2 study and that they are
having parallel discussions on phase 3 planning for all ways to appease individuals with health authorities. In our mind, that of course, stronger messaging than what we have done before, but it's in the line. It's a step forward in the messaging and it just underscores the confidence we believe that during a half in the program and also have two words of opportunity to move into phase 3. But as you know, I cannot comment further on these details because...
We have not seen the Phase II data yet and it is up to Bern to provide the further details to the program but we sent it out of confidence in the program and also confidence towards the opportunities to move to or space 3.
That's great. Thank you very much. Thank you. We will take our next question.
Next question comes from the line of Brian Bolshin from Jeffries. He's going to have your line of open. Hey, it's just Brian from Jeffries. Just a quick clarification on B.I. 960 and obesity. Is there a potential milestone associated with the initiation of that phase three? Thanks for that question, Brian .
We only guide on, you can say, outstanding milestones and RRCs and we have around 350 million euros in outstanding milestones and high things to load WRCs to the program. I think it's fair to assume that it's a critical
pre-clinical bill that we made and we have received my phone, as you can see in our earlier reports when we initiated phase two, which was around 20 million euros. So I think it's perhaps assumed that we would get something also when we pass specific development steps and also with regular term commercial. But we do not guide on this specific...
So that is back to what and the edit that those will only come once we open. Thank you very much. Thank you. We will take our next question.
Our next question comes from the line of Michael Novich from Nordea. Please go ahead. Your line is open. Thank you very much. So a couple of questions from my side as well.
First on the paper side, would you expect that it's possible to have the initial results available by year end 2023 or early 2024 from the investigators sponsored the Phase 2 trial? And secondly on...
BI 456906, given sort of traditional timelines, would then be fair to assume that data will be out at ADA, and secondly also that at that point in time, Birmingham will have likely clarifications of the ongoing discussions regarding Phase 3 plans with the regulatory authorities, i.e. that they will also like.
Now it's in the hands of Novo. We haven't seen any sort of notable traction thus far. When would you expect that we start to see something on Siegelark? I know it's not a key drug for you guys, but still it would be nice to see that it gains some traction in the US. Thank you very much. Thank you, Maris. For good questions, if I just start, I'm Siegelark.
We can say we handed this product over to no one in the second half of last year. Of course, we would expect to see some traction coming into the year once they get the hands around. But as we have also all the time said, it is not the most important part of our value or equity story to see. It's an incredible important product for patients and we are extremely happy to see that.
It's in the hands of no one always, but of course we would expect to see traction and also that the product start to provide some contributions to our revenue in the future. And one of the activities that we have focused on this year at the end, and I think our situation application so we could also potentially get the product into the European market.
On the journal collaboration, 906 and the assumptions around when BI will make decisions and so on, I'm really sorry that I cannot make more comments. I think we have gone as fast, we can go right now in the comments, but as I said before, we feel very confident that...
that B.I. is confident in how to use this product and forward. And I think it's also clear that they see it as a very important potential product in their pipeline. So I cannot comment further on this. Those speculations I will have to leave to you guys. On bad week's time, we're just about to start the study as a baby's fed and
And maybe they would even share a little bit more of an item what we intend to achieve here, but I think it's more like the early 2020 goals in the A to the D. Yeah, Michael, thanks for the questions around BAPI. The investigator led trial, we have successfully navigated the requirements now in Europe for CTA, C-C-I-S. And as I said, we anticipate the initiation of the first patient within the coming days.
The timing of the final data availability of this quota to Adam's point is very likely to fall right around the change in years. So we would anticipate that in early 2024 we would have those data. And obviously we ourselves are planning progression to the dose ranging, an integration study phase 1b. So all of that is in play for this calendar year and we look forward to.
more comprehensive data availability from the investigator let trial on our own programs in the first part of next year. Okay, great. Maybe I can just throw in one, one, there's no follow-up question to sort of the sort of the partnering preferences because you're getting phase one data for the eminent law.
role, or would you rather prefer to do individual partnerings on these projects like the MLN in Depitletive and also the GIP.
That's a very good question, Michael, and I would say we are open to both scenarios. I think the most important part for us is we believe, especially for the tree assets, the tree preparatory assets where we have all rights, we believe this represents a very very significant value of potential for this company. And you know, you know, you meet situations here, it's actually not that open.
biologic companies find themselves in a situation where even those who are really clinical Programs it is they are quite mature when you compare across the industry to look outside Maybe and all that so and we know that it allows for our A group of companies who we would normally expect to be in this space But they do not have the richness of the pipeline you would expect so we are in a very very unique situation And we also as we have said today fully It is really committed to continue investing and putting all the effort into these programs as needed in the next couple of years
When we before we end up there is three, it would be very logical to have a partner on board. And I would say also, of course, it could also be logical to have a partner on board earlier for these programs because of the potential value they carry. But our purpose is perhaps not so much if it's one partner for all three assets or if it's
or you need to stop, we have in the pre-clinical pipeline, all the individual partnerships, the most important part for us is that if the right partnership, it's a 100% committed non-spammer company, and we have the opportunity to continue to contribute, and thereby also retain more the value of police programs because of the value potentially we see with them.
even stock we have in the free clinical pipeline, or the individual partnerships, the most important part for us is that if the right partnership is a 100% committed non-span economy, and we have the opportunity to continue to contribute, and thereby also retain more the value of these programs, because of the value percentage we see with them. That's great. Thank you very much.
Thank you. Thank you. Thank you. We will take on next question. Your next question comes from the line of Tsushima, Kronande, from Van Lanchot. Peppin, please go ahead. Your line is open. Yes. Thank you for taking my question. So for the eminent analog single ascending, I'm not ascending those data sets. It is coming out in H1 and H2 respectively. Can you provide some context on what we should expect in terms of number of subjects and metrics and biomarkers?
as we have with CHI, we really like to have all our data in place before we open up data room. But having said that, we have multiple instances with TARDIS as with CHI. And we have progressed dialogues, but we do not anticipate to open up data rooms. So we have all data in place. Basically, it makes it too complicated if we have half-big data stories. So that will give you a little bit of an idea on the timeline for that. And...
I would say for the later, it's a little bit the same type of partnership as with CHI. Perhaps you can say for the later you need organizations who have a little bit stronger commercial footprints, because it is going to be a competitive situation where the CHI is the more, it's going to be potentially the first that can introduce something for these patients. So there is enough just to have the radices infrastructure to support the virus get to the market. On the timelines and the data and studies on emulating because it is one of our key opportunities where I will ask David to just come a little bit on that.
Yeah, thanks for the question. And, yeah, phase one, as you well know, if not always the space for the most creative study designs, the safety and powerability, and ensuring we have adequate exposure to our AMO analog that will inform dosing for phase two is obviously key to those studies. But as we have reported, we've completed the single ascending dose study and those data, we believe we'll give us the first glimpse at the potential.
impacts on body weight, much as you may recall for our DAPI gluteide asset despite relatively short exposure, one gets an early perspective on the potential for its impact on body weight. And phase 1B will give us greater insights into dosing, though, that escalation and longer exposure that will allow an even more granular look at the potential clinical impact.
in specific in terms of body weight loss targeting that that's for obesity. So I won't over promise from phase one, phase one B set of studies, but much as we've seen with other assets in the obesity space, I think we can get significant insights as to their clinical effect, even in these safety tolerability and dose finding studies. Thank you.
Thank you very much. Thank you. We will take on next question. Your next question comes from the line of Jasper and Nilsa from Coliseum. Please go ahead. Your line is open. Thank you so much. A few follow-up questions from my side. So firstly, on partnership, deal updates, just to understand you guys here on the call. Is it still the base caves to start partnership?
discussions on clipacklet type due in Q2 or is that more Q3 now do these they Gathering of the full 24 week interim data on clipacklet type. So is it really start the progress with structural Partnership progress in Q3 now is that fair to assume then on CHI Can you just confirm are you still in partnership discussions and would in that case be fair to assume a potential deal during the second half this year or could as they'll be barely then I have some follow-ups afterwards. Thank you.
So let me try to clarify. So both CHI and cookie factor side we have had multiple interactions and we have multiple interest and have discussed discussions at several levels.
Regarding moving to the daily on space and getting into the very detailed discussions, we have, first of all, we are providing to have the data and space for CHI that is going to be the case, as you know, very soon, because we are hopefully soon to submit the MBA. So, and also we expect a fast review with the FDA. So, the FCHI partnership is our first priority this year.
because we expect to have a partner to launch with potentially already close half of next year. Another key priority for us is of course to once we have all the data and how they engage in discussions in more data and data and discussions on the practical time. And whether that's going to start in the second or third quarter, I think it's...
It's not something I can comment on, but it's, it's, I can comment on our priorities and that is basically due to long timing. That for CHI, it's important for us to have a partner and face before later because we live as you know, we expect the 12 months, we have only a submission in the second half, but we have more time. And then for a BCT, it's a little bit optimistic to where we just keep dialogues on goal. So that is my state of priorities and then.
And yeah, I hope that answers your question. Thank you. Just follow up then to this. You try sales opportunity. So based on your slides and you've also previously shown this, it indicates a 400 million total addressable market or more. Do you think that we underestimate this sales opportunity and based on the discussions you've had with partners so far? Do these partners agree with this? Or is this just, you know, the theoretical sales potential or not, what could be the base case?
Yeah, I would say we have not shared market research yet. So what we have done is we have we have a pretty good idea about as good as you can have for a rare to see where which really don't have any good treatments today. How many patients would be available in the key centers and then when we cook that down to say who are the ones of these patients who we truly could be candidates because they have insufficient resources to current ways of managing the patient. Then we get to a number of 800 and that is within the target population of the patients that we would hope to have it.
see that it not of the digital patients would be higher once we start to, if we have a card that is available to patients. And then I would say another thing that we are looking into when it comes to high-go insulinism is also if we should start to consider programs for adult patients because we think that's not the opportunity to expand into those as well.
So, on the value of a trunancy, we have only so far decided to provide examples of comparable products which have longed into rare disease or the rare disease market. And we have not shared any specific market research on our program, but I would say.
If we provide sufficient clinical benefits, which we believe our program has demonstrated, but of course, ultimately we have to see the potential label, then we think it's good comparisons. So I would say later this year we would share more on this, and this is of course as you can imagine also.
the conversation that we would enter to partnership discussion with is this along with other ideas that I share here. So, please, thanks for taking my questions. Thank you. We will take our next question.
Your next question comes from the line of Mark Prasal from Morgan Stanley . Please go ahead. Your line is open. Yes, thanks very much. It's Mark Prasal from Morgan Stanley . I have three. Firstly, on the 906. I wonder if you could help us understand the initial impact you see in the heart rate with that asset. If you...
has been done. I know a parallel here to what's going on with Lydys triple G agonist. The second one on on on on Dapaklutide, can you help us understand how much further you're going to likely push the dose in your 13 week dose ascension study versus the the investigator led dream study. I'm just wondering which additional benefits you expect you might be able to see.
as you push up the dose, both on the JLP1 and the JLP2 component. And then lastly, on the Amelene Analog A396, two parts. Have you seen any potential here in CKD? Other companies that are playing in the space have mentioned potential benefits in renal patients. And then part B, when you talk about combination studies, are those within your own portfolio? So with that B,
Are they potentially with Burringer? Have they shown any interest in combining Amelene with 906? Or is this already in an early stage looking to seek partners who have complementary assets? Thanks very much. So I've got him now, Handa, what's your favorite thanks for the question, Tom? So if we get to start with it.
with the 906. Then I think I am very certain that the hardware observations in the time two study has nothing to do with learners priorities regarding PVTMS. I think it has been the key for the more the time. I think it is extremely encouraging to see the very...
good glucose control, the product also provides, but a sub-diabetes management is more saturated today, and more treatment charges, whereas in a BGTNM, that's much, much bigger need for new and novel treatments, so that is the flow for them. And maybe just one more, and they do want to come in on the hardware observations, because... Yeah, Mark, thanks for the question, and as you're probably well aware, virtually across the panel of potent GF-1 receptor agonist, and I've had exposure to a few of them over the years...
Particularly, the dose is pushed. That increase in heart rate is a known consequence of these long acting jopas one agonist. But obviously, there are plenty of encouraging data on cardiovascular risk with these same agents in the type 2 diabetes space, reducing cardiovascular risk, likely reducing the risk and progression of rheumatoids. So despite that, no one affects on heart rate. As Adam said, it has been clear to us and made quite clear, we think, by the eye that their priorities have been obesity and ash, but given what is known about the jopi one receptor agonism.
having a clear understanding of its potential impact in tech-to-beauties and perhaps informing future life cycle management decisions. But the focus is obviously obesity than that for that asset. I'll also address your other two questions on the Dapagulatide.
dose escalation. Obviously the investigator-led study is in great part in the hands of that investigator and because many of the outcomes are mechanistic, they have a somewhat different dose escalation and maximal dose that we would anticipate will be slightly lower than that plan for our phase 1B.
So as with all of these GF1-based therapies, it is really looking to achieve a balance between optimal dose exposure, and the highest dose possible given its tolerabilities, but also having an understanding of what titration scheme will allow you to get there. So our...
efforts in Phase 1-V will be person-formist to assess the efficacy, but also to gain a clear understanding of what those scheme, meaning titration and maximal dose can be used in effective or in the Phase 2 and beyond.
So I hope that gives you some clarification. Finally to Amel and the 8396, the combinations as I alluded to in my remarks, really this opens a number of possibilities. Our asset, as you know, is co-formulatable. We've presented non-clinical data co-formulations with the GOP1 receptor eigenus with our DAPI group side.
Asset as a co-administration. So really the opportunities to combine with any and all other encryption based therapies on something we don't see likely with Cigril inside, given how it is being assessed and likely brought forth for submission. But that free standing or loose combination opportunity, and ultimately if there is interest to co-formulation possibility for fixed dose combos.
who really do exist based on what partners may be most interested. You're comments about the CKB. Obviously, at any weight loss age of the lower burden, fat and lean body mass, and also can reduce blood pressure, like we've seen with the SGTL. T2 inhibitors, the GFD-1 receptor agonist. So, yes, we are intrigued by that potential opportunity, but first and foremost, as we've said, our focus.
will be on assessing our AMO and Agonist in the obesity space. But these other value abs, if you will, will certainly be on our radar as we get into base two in the arm. Thank you, David. And just going back to the hot reading, Chris, if I'm missed. So we're triple D and most do so. You're seeing up to 30 beast a minute, which you'll be on the system, it's like six to seven beast a minute. Obviously it comes down with a triple G over time and most do so over time. But it's something.
I think it's another important aspect here to recognize that diabetes started where they did their class dose type, dose type creation. So it was really suboptimal dose type creation for our molecule with a lot of nausea and vomiting. So all that is absolutely to the observations that you've also seen on halfway. So
And I think the key difference here is that we have a lot of tears, we want to both just as David says, the other tears to one. So we have, perhaps not, we don't die as too much into the key case argument for other tears to one's goons. We think it's actually more a question of if you have tears to one and both then you will get, you will observe the same pharmacology as has been seen with other tears to one. If you don't have, if you want to both then you might more see what you could expect from that war line. So we think it will, yeah. It represents, it represents, click.
and maybe too bad those escalation in order to get to if they get to eat out and this is of course something as you also mentioned then you get into the long-term studies you can address this and titrate in a more sensible way. Yeah, Mark that happens to that. You're right with the long acting agonists particularly with the slower titration schemes that have ultimately been brought to market.
and included heart rate increases as part of that decision tree. The Adam's point, both the total exposure to GLP1 and the rapidity with which you increase the GLP1 exposure can have significant impacts on heart rates. So it would not overread into particular shorter term studies that push the dose quickly. And obviously we'll have, we hope, the data from the OB-City population with BI.
4.5, 6.9, 6.8 very soon to get a broader look at a much longer exposure in the 46-week study, which for us is obviously an important piece of data to understand the full safety and efficacy profile.
That's great, thanks very much for the colour, really appreciated. Thank you very much. There seems to be no further questions, so I would like to hand back for code and remarks.
Okay, but with that, we'd like to thank all the attendants for all the good questions and we do very much forward to connecting our future announcements and updates. Have a great day.