Q1 2024 Zealand Pharma A/S Earnings Call
Yeah.
Good day, and thank you for standing by walking to the Q1 financial results Interim report first quarter 2024 conference call.
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I'd like to hand, the conference virtual Speaker today, and then cross sell Sky, Vice President Investor Relations and corporate Communications. Please go ahead.
Thank you operator, welcome and thank you for joining us today to discuss Zealand's results for the first quarter of 'twenty 'twenty four with me today are the following members of <unk> management team, Adam <unk>, President and Chief Executive Officer, Henrietta Dominica, Chief Financial Officer, and David Kendall Chief Medical Officer.
You can also find the related company announcements and interim report on our website that Zealand pharma Dot com.
As described on slide two our caution listeners that we will be making forward looking statements that are subject to risks and uncertainties moving.
Moving to slide three I will turn the call over to Adam <unk>, the President and CEO Adam.
Thank you Anna and thanks to everyone for joining today.
I'm very pleased with the performance of our business in the first months of 'twenty four.
Progress we have made set us up for an extremely exciting next few months with key clinical results from all of our programs targeting obesity.
And continuous productive interactions with the FDA on our two rare disease programs.
We have completed the phase one multiple ascending dose trial with Katrina tie and investigator led trials with that ecocide.
Both programs are on track for top line results in the second quarter.
Corporate training time, we aim to develop this molecule is an eternity to the tier one based therapies for weight loss and it couldnt be weight maintenance.
As we believe the specific mode of action could provide a better patient experience and address some of the shortcomings.
Associated with the one based therapies.
With that in due time, we have a truly differentiated one containing molecule.
Designed to provide significant weight and of course with the added potential to address the low grade inflammation associated with Mr. Pollack diseases.
She was a dream trials, we expect to mainly game mechanistic.
Insights into the effects of the tier one and tier two receptor components. As this chart only included lower doses that are good sites, and thus will be less informative waco's potential.
In the second half of the year. However, we expect topline data from a 13 week dose titration trial investigating significantly higher doses of that the good side.
In February our partner been Ingelheim reported ground grading topline results from our phase II trial with several <unk> and mesh providing evidence of effect on fibrosis.
Clear differentiation that precision several times as a potential future, leading increasing base waitrose medication.
Results from this trial will be presented at the <unk> Congress in early June.
In rare diseases, we now have to do for cold days, but both basically organ.
Dennis and hyperinsulinism, and circling back to China, and short bowel syndrome in the fourth quarter.
Lastly, we significantly strengthened our balance sheet through a private placement of two renowned international investors in early January securing a runway into 2007.
Moving to slide four.
With the strong start of the year, we remain on track to deliver on our key priorities for 2024 wells.
We look forward to important clinical results for both codes for inside and they have a good time that we anticipate will position us to advance into large comprehensive phase II b trials, and thus significantly expand our efforts to work developing the next generation obesity treatment.
To address what we believe is the largest health care change we have seen in modern times.
For the past year, we have already made significant investments into the organizational capabilities required to deliver on this next development phase and we expect to accelerate those efforts as we progress through the year.
Our two rare disease assets that you can log on and congenital hyperinsulinism and prepare.
I could cite for short bowel syndrome, and exit value by the FDA received to date in Q4.
In parallel with the regulatory process, we are engaging in partnership discussions for future commercialization.
We are also advancing our preclinical programs targeting chronic inflammation towards the clinic.
We expect to initiate first in human trials with our K, one country and channel program. This year.
We intend to provide an update on the potential next steps with a complement <unk> inhibitor in due course.
Moving to slide five I will now turn over the call to our Chief Medical Officer, David Kendall to discuss our R&D pipeline.
David.
Thank you very much at them today I would like to focus my remarks on the continued advancement of our obesity program and also provide an update on our regulatory progress with our two rare disease assets.
Turning to slide six.
I will begin with <unk>, our long acting amylin analogue.
Emlen Agonism provides a unique and distinct mechanism for achieving weight loss in people with overweight and obesity and represents an exciting potential alternative to acreage in based treatments.
Amazon Agonism reduces body weight by enhancing satiety and restoring leptons sensitivity in contrast to the reductions in appetite and perspective food intake that are observed with GOP one based therapies.
Furthermore, non clinical data have demonstrated that amylin agonists, including controlling tide offer the potential to preserve lean body mass and therefore provide higher quality weight loss when compared to acreage in base treatments.
In addition, both our own observations and clinical observations with other Amazon analogs have demonstrated improvements in cardiovascular risk factors, such as blood pressure lipids and markers of vascular inflammation without increasing heart rate supporting the potential for improving cardiovascular risk.
We have previously presented data demonstrating a mean weight loss of more than 5% and healthy lean and overweight and obese individuals after weekly doses of both <unk> six and one two milligrams administered for six weeks with these data presented in full at obesity week 2023.
We remain both optimistic and excited about the potential for our amylin analogue and are very encouraged by the significant weight loss observed which is similar to results reported an initial short term studies of <unk> based therapies.
Importantly, we also believe that the Tolerability profile.
Controlling tide offers the opportunity for a considerable improvement compared to the adverse event profiles reported in clinical trials and experienced in real world settings with acreage based treatments.
We are on track and expect to report topline data from the 16 week trial a trial entitled late this quarter.
In this phase <unk> trial, we are exploring significantly higher doses of controlling time use.
Using a dose titration scheme and.
And we anticipate this trial will inform both doses and dose titration schemes plan for a comprehensive phase III <unk> trial, which is expected to initiate in the second half of 2024.
In line with Adam's initial remarks, GOP, one like weight loss. After 16 weeks would reinforce our conviction that <unk> has the potential to be an effective monotherapy can may represent an appealing alternative to GOP, one based therapies for both achieving and maintaining weight loss.
We truly believe that with the truckload side, we have a unique opportunity to establish a new class of therapies for the treatment of overweight and obesity.
Turning to slide seven and turning our attention to <unk>, our first in class and only in class dual <unk> receptor agonist.
<unk> is designed as a potent <unk> agonist targeting significant weight reduction and offers the potential to also leverage <unk> pharmacology and improve gut barrier function as well as addressing the low grade inflammation associated with metabolic disease, representing a truly differentiated increase in ASP.
Yes.
And obesity low grade inflammation discussed to further drive many common comorbidities and we believe that dual GOP. One GOP two receptor agonism can play an important potential role not only targeting weight loss, but also directly affecting a number of key obesity related co morbid conditions.
<unk> liver disease, cardiovascular disease, and neuro degenerative diseases, including Alzheimer's.
We anticipate reporting topline data from the investigator led phase Iia Dream trial in the coming weeks.
Speaker Change: Brian was specifically designed to provide an initial assessment of the potential of that being tied to both reduced body weight and target low grade inflammation as well as address a well described abnormalities in gut barrier function.
The initial top line data, we will focus on weight loss as well as safety and Tolerability and we look forward to further detailed results assessing and inflammatory markers and got biopsy findings, which will be presented at future scientific meetings.
Speaking to the wage cost potential with Duffy Boutade. It is important to highlight that the dream trial is exploring dose strengths of Dappy up to 6.0 milligrams, which were also assessed in the previously reported multiple ascending dose trial, where a mean relative reduction in body weight of four 3% was observed.
<unk> after weekly doses over four weeks.
In the ongoing phase <unk> trial, we are exploring significantly higher doses of Debbie Glu tied over 13 weeks of treatment using a dose titration scheme and we expect topline data in the second half of 2024.
These data will be used to more fully inform plans for the larger phase <unk> trial, which is expected to begin in the first half of 2025.
Turning now to slide eight and the servo do tighten program.
The glucagon GOP, one receptor dual agonist being developed by very very ingelheim.
Beringer reported the exciting and impressive top line data from the phase II trial with <unk>.
And people with metabolic dysfunction associated Seattle, hepatitis or Nash in February.
These data demonstrated that 83% of participants treated with <unk> showed an improvement in biopsy measures of mash without worsening of fibrosis.
Pages F. One F to announce three after 48 weeks when compared to placebo.
Importantly, several new titles met all secondary endpoints, including a statistically significant improvement in liver fibrosis.
This is the first report demonstrating an improvement in fibrosis with the GOP, one based therapy, providing evidence for differentiation among GOP, one containing weight loss medications.
We look very much forward to seeing these data presented in full at the upcoming European Association for the study of the liver Congress and Milan on June seven.
Based on the positive results from the <unk> 46 week phase II trial in people with obesity and overweight presented last year at both the American Diabetes Association and the European Association for the study of diabetes as well as the positive results from the previous 16 week phase II trial in type two.
These patients sort of a do tide is now in phase III for the treatment of obesity and overweight with recruitment into the trial is progressing very well.
Beringer have also communicated that they anticipate moving forward with phase III studies and match as quickly as possible.
Now turning to slide nine for an update on the regulatory status of our program for <unk> and congenital hyperinsulinism.
Following the complete response letter issued by the U S. FDA in December of last year identifying deficiencies of a third party manufacturing facility that were not specific to Darcy glucagon. We have now resubmitted part one of our NDA. So called original one which targets dosing of <unk> glucagon up to three weeks.
Duration.
This NDA has now been accepted by the U S. FDA with a <unk> date of October eight 2024.
This represents a significant opportunity for Zealand to address a major unmet medical need for these children and their families.
If approved we plan to make <unk> glucagon available to U S health care professionals and patients as soon as possible and continue to actively engage with potential partners for future commercialization.
We also expect to submit the additional analyses requested by the FDA from existing continuous glucose monitoring data sets and supportive part two of the MBA for dosing beyond the three weeks in the second half of 2024.
We anticipate that longer term therapy will be necessary for the vast majority of children living with congenital hyperinsulinism.
Turning to slide 10, and then <unk>, our long acting <unk> two analog that we believe has the potential to be the best in class therapy for the treatment of adult patients with short bowel syndrome, and intestinal failure, who are dependent on parenteral support.
As we have previously shared the NDA for <unk> was submitted in December 2023, and is now under active review at the FDA with a <unk> date of December 22024.
As with our <unk> program, we are actively engaged in partnering discussions for <unk>.
And with that I would like to now turn the call over to our Chief Financial Officer Henriette of Anarchy to review financial results for the first quarter of 2024 Henrietta.
Thanks, David and Hello, everyone, let's move to slide 11, and the income statement.
For the first quarter, our principle is $15 million DKK. This was mainly driven by.
The license and development agreement with Novo Nordisk was taken up.
Operating expenses for the period by $206 6 million DKK, driven by research and development expenses. This represented 72% of seasons Opex.
Increase in research and development expenses compared to the same period last year is driven by the clinical advancement of our obesity pipeline and activities supporting the regulatory review.
If the eight of the late stage rather she says.
Selling and marketing expenses, primarily related to activities associated with particular recon fishing and make it available to patients in the U S. Once approved.
The increase in admin expenses is a result of a strengthening of the it infrastructure and organizational capability in selected corporate functions as well as legal expenses related to our patent portfolio.
Net financial items in the first quarter of 'twenty to 'twenty four.
<unk> 6 million DKK are mainly driven by interest income.
In marketable securities.
Let's move to slide 12, and the cash position.
As of March 31st cash cash equivalents and marketable securities.
<unk>, three 2 billion DKK and.
And $3 6 billion DKK, including Undrawn credit facilities.
In Q1, the balance sheet must significantly strained.
In January we raised one five.
5 billion DKK from a diamond issues and private placements of new shafts.
Speaker Change: And in March 28, after loan facility with the European investment Bank is dispersed over sending 50 million yes.
With a cash runway into tranches tranches seven <unk> has never been in a stronger financial position.
This solid foundation and allow us to invest in our own wholly own obesity programs at the right speed and quality.
As we conclude first one and then Bob on initiating last phase <unk> trials.
At the same time, we are on a strong position to continue the more detailed partnership discussion radishes programs.
And this takes me to slide 13, and our financial guidance.
Let me keep this brief as our guidance is unchanged. We continue to guide for net operating expenses of between one one and $1 2 billion DKK.
And with that I'll move to slide 14, and turn the call back to Adam for concluding remarks.
Thank you Hendi.
We are rapidly approaching some of the most exciting weeks and months in the history of sealant.
Our differentiated the PCT assets hosted transformational potential and could elevate the company into a new leak.
A quick trading side, specifically, we have an opportunity to create an entirely new class of medicines for weight management and.
And does play an important role in framing the future landscape.
For treatment of obesity.
Within the next 12 months, we expect to be well into large comprehensive phase <unk> trials for both <unk> and David good side.
We have invested significantly in setting up the organization for this next phase of development Ciena is ready to move ahead with speed and quality.
Also within the next 12 months, our two <unk> programs will have completed the regulatory review process in the U S. With both taxi grew up on in congenital hyperinsulinism and Petco type and short bowel syndrome, we have an opportunity to address major unmet medical needs of patients.
Finally, our next wave of peptide innovation targeting chronic inflammation will have ended early clinical development.
Thank you all I'll now turn over the call 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.
Please standby.
Your first question comes from the line of Bret Jones Sharma from Goldman Sachs. Please go ahead. Your line is open.
Hi, Thanks for taking the question I think it was sort of a second quarter in a row as being kind of new obese two days from the day of your quarterly results. A similar question to last quarter could you just provide.
Your thoughts on the extent to which the raw stage. This morning, as well as kind of other competitor Readouts recently changed the dynamics in terms of the profile that you think you need to achieve with petrol and Todd <unk> Todd if at all.
And then just kind of a second follow up on <unk>.
Partnering discussions on <unk> now that you have the <unk> date, so both in more clarity on the competitive landscape in short bowel syndrome, specifically should we expect updates on those processes. During 2024 is that likely to come after the respective produces thank you.
Thank you for those questions I will start and maybe David will add some flavor is also on the you can say data readouts.
WCS in the PC space, if I start with the updates on the.
Radices programs in partnering discussions then.
At this call each week.
We now communicate our paducah date for their retail one which is the <unk> indication and also on our intention to submit original two in the second half and we continue to have good dialogues there in.
In parallel as.
They also expressed and David as well we are preparing for making this product available to patients once approved and the continued partnership discussions with the full ambition of having a commercial partnership established at the right time. So we have a good dialogue and <unk>. We have just started those discussions.
The acceptance of the <unk> and also data readout from our from one potential competitor so.
Happy with where we are on those discussions they have been now started and we have a significant interest as you can imagine.
With a potential to two.
Half.
At best in class molecules to address unmet medical needs for patients Chophouse syndrome that is that is of high interest that would say so we will of course communicate to the market once those discussions materialize.
But we will not provide specific guidance on win Ivo I will share that also that we are of course in parallel the dose discussions also making all the commercial patent is to be able to launch the product, but we will provide updates as we progress those discussions.
Regarding a clinical data Readouts I think it is.
No surprise to us and I don't think it should be to any of that we will continue to see more and more data readouts in this space as we see it more in <unk>, an important thing Kristina.
Truly focused on.
Developing differentiated assets and not you can say hey.
Things that are carrying the same mode of action of medicine that you already have on the market on late stage development and I think that is.
From our point of view dataset regarding molecules that are based on <unk> IP backbone, it's not something that really changed our view on how we would precision of our molecules.
Because you can say.
It is it's already you already have you can say products like that either on the market and development. So.
Our focus is to come up with.
<unk> differentiated products that either target.
Comorbidities of obesity in a differentiated way compared to the existing inputs and based and that is mainly for products, where we have tier one as a backbone like with distributor side of it. That's a good sign and then of course, we continue to discuss more about <unk> and <unk>, a novel class and and here I would say the data for any deal.
One would not change our scope here an opportunity to develop something for those patients who would.
We don't have perhaps the optimal experience in the tier one we don't think any of the other tier ones would be among many of those patients are the obvious choice, but a novel non equity based making these would be so.
So for us it doesn't change our plans and I would also say in my mind also it doesn't change the future health care space.
You can say in the sense that.
There'll be plenty of opportunity to differentiate with novel.
The entities in the future.
David do you want to add anything to.
Yes, Thank you Adam.
We wholeheartedly.
These data.
Roche and other recent reports with <unk> based therapies do not substantively change are there our perspective or the landscape.
Follow.
A follow on to what has now been reported with the true upside in many settings.
Speaker Change: But to Adam's point, I think for us the data readouts and the advancement of <unk>.
Information for example, Lilly's <unk> agonist.
Amylin or combine Damerlin GOP one program.
Novo have added further strength to our position which is but.
Our <unk> agonist patrolling tied to us still.
Very important potential role to play.
And so this unique mechanism as Adam referred to.
Stinker of mechanisms of action.
Potentially a distinctive tolerability profile with them to see that so we would hope would.
At least mirror that of the GOP one alone class.
For us that is really the information that those havent strength to the story that we believe patrolling Todd.
<unk> agonism can play a critically important role.
Thank you.
Thank you.
We will take our next question.
Your next question comes from the line of Lucy Codrington from Jefferies. Please go ahead. Your line is open hi.
Thanks for taking my question and just been following along.
Thanks <unk>.
Moving to phase two just wondering if you could talk us through the relative importance of.
Activity.
Calcitonin for these long acting amylin assets.
And how you think patulin Todd may be differentiated from some of the other assets out there.
And secondly.
And Nathan bearing grit spill to the small number of <unk> based phase three study they'd be subjects with Nash I presume. This is separate to two <unk>.
The study will be Pat and I just wanted to I appreciate that.
You'll see today, but any thoughts on the rationale for that specific study.
And then just on the <unk>.
Recent collaboration with beta Bionics Zara.
And what the potential implications are for designees Goldman in artificial pancreas, given that that deal does appear to be exclusive.
Services, Inc.
Thank you John.
And whether we should therefore, what that would mean to the phase III that may or may not stock.
Yeah.
And then sorry, one more quick question just on I.
I presume given the lack of commentary that unlike designated on this isn't something you would consider making available Washington wait to seek a partner.
Just a confirmation that thank you.
Thank you <unk>, maybe I'll start and then.
David will add as well as a base if we start with the impacted side. We are you can say.
Engaging in the prelaunch activities needed to be rated two two.
That anybody would need to initiate to be made to the program. It is of course, our key ambition to have a partner on board before we launched the molecule.
And we have good discussions here and it is a different you can say animal if you will than launching into an ultra rare indication ehi. So so you're correct on that.
<unk> assumption on the beta bionics a collaboration we also expect to provide further updates.
In the coming months to the market as we progressed discussions with with beta Bionics I think it's important to note that we have a nonexclusive collaboration meaning that we could work with a pump company in this space and our understanding is that beta bionics series that now engaged in an exclusive collaboration regarding that.
That does not change our you can say collaboration but again, it's important to have non exclusivity to work with any pump manufacturer in the future for these indications.
And we will provide updates as we progress through the year on this one I can also on your observation on the page smaller phase III study in obese individuals, which debuted types who also have matched.
That is also our understanding that this is Noah program that is targeting the obesity indication and we should expect.
<unk> is specifically related to mesh development, but again, it will be up but the amateur comment on those things.
Lastly, and Im sure that David will add something he as well on the amylin and Kathy Tony we of course.
Having a very good idea of what we have and we also have some idea about a couple of <unk> type because it has been.
And around for a long time and at least.
EBIT that you have to.
To have the most effective.
Molecules you'd need to be addressing both receptors both yes.
In the right bands and we will provide further updates to the market and how we haven't addressed that relative balance.
And other aspects of the molecule.
Sorry.
<unk> molecule and other molecules, we don't have the same insights yet and you can see ultimately.
I guess clinical data.
Inform us.
What I can say is that.
The transformation that we've observed from the animal studies into the initial clinical evidence of wage and always has been.
Issuing an online.
Onto something that looks.
David any comments to that.
Yes happy to add a couple of notes to Devin Lucie Your U S.
Colleagues provided a short summary of the other day.
<unk>.
Understanding the receptor biology, I think we're in the early stages of that understanding Adams.
Adams point, we do believe that this complex receptor system with Avalon the calcitonin.
Activation apps, both receptors maps true that grows but.
Emily.
Compounds activating both emblem pure amylin receptor is pure Tony receptors.
We believe is one of the components is important for promoting significant weight loss.
As Adam also alluded to we will provide further characterization over time of our molecule.
I think that also ties back to other components of these molecules beyond receptor biology.
Long half lives with stable drug exposure.
Kinetics.
As demonstrated in other classes of medicines, and we believe will be demonstrated with long acting amylin analogue.
That will be another important contributor to the impact on body weight.
And then finally, the mechanisms I alluded to in my prepared comments.
Namely that this is a very distinct mechanism the mechanism of <unk> versus <unk>.
Lawsuit perspective, food intake or the desire to each with GOP wonder acreage <unk> based therapies as well as the leptin and sensitizing nature of Emlen Agonism, we believe can contribute both to the experience at the patient level in terms of how they feel when they are taking the medication.
<unk>.
The side effect profile, we've already talked about and then.
Maintaining that wave costs through each of those mechanisms. So for us. It is uniquely positions based on much more than just the receptor biology.
Important question. Nonetheless, so thanks for your question Lucy.
Thank you.
Thank you.
We will take our next question.
Your next question comes from the line of Thomas Bowers from Danske Bank. Please go ahead. Your line is open.
Yes. Thank you very much a couple of questions from my side. So so still kicking off with with amylin. So so the phase III.
So I don't know I'm a bit early out here, but I'm, just trying to get a bit of understanding on future timelines here. So so are you potentially targeting 40, plus minus weeks or could you maybe even see a potential reduction given that you might be able to try trade fastest so so just to get a feeling on how to order.
<unk> as fast as possible to work.
Speaker Change: The pivotal trial and then just on <unk>.
Just wondering whether you had the mid cycle reviews, yet and then do you have any indication from FDA regarding a possible outcome here.
And then on therapy.
You mentioned it in your prepared remarks, but I just wanted to just double check. So so so the topline data we get from the dream.
There's not going to be any information data at all and those topline data so that will only be safety and weight reduction.
And then just lastly.
Just on the complement for CRE is that something that you see that you want to advance on your own or has to tell you the competitive environment changed given that <unk> is not pursuing this.
After all thank.
Thank you.
Thanks for your question Thomas that with document.
<unk> and we cannot provide further you can say comments on these programs we are negotiating the return yes.
Dan.
<unk>. So we will provide updates as those discussions have.
That being completed.
So that the good side.
It will be the topline Wade and safety data from the lower dose that will be reported in the mechanistic data will be presented at Ada scientific conferences.
Speaker Change: So you are correct in that node and then of course in the second half it will have the phase one EBIT titration at significant higher dose exposure that will also be recorded this year.
A playback beside the mid cycle revenue is still ahead of us.
Speaker Change: Course approaching and.
Speaker Change: We have no indications of that old ships. So.
And then for imaging.
Speaker Change: It's a bit early for us to provide all the comments on the case.
To be designed what we have said and what we also maintained is that this will be a very large and extensive.
The phase <unk> study.
Maybe has assigned.
Quantity in my mind and.
And speed of course.
So I.
I would say.
It will also required a number of weeks needed to fully understand the potential of commodity like Amazon before we move into phase.
Phase three with this opportunity.
And also the appropriate titration and so on so you can expect a very thorough phase <unk> study.
Thank you 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 Lowe Hendley from Baird. Please go ahead. Your line is open.
Laura Hindley: Hi, Louis <unk>, Thanks for taking my question.
And my question is on your partnership.
Has there been any change in the cadence of your interactions with potential partners.
Europe, so far this year versus last year can you remind us of what you see as the ideal time to even to find partners.
And then Todd and Duffy Great side, and then how Youre thinking is evolving on S&P <unk> readout have any bearing here.
And then as a follow up on <unk>.
Hello value for weight loss that you will need to see in this phase one b trial to go ahead with your planned phase II, Okay and final one on Nash.
No.
Okay. Thanks, guys.
They can deliver.
Statistically significant fibrosis benefit and less larger and longer phase III trial.
It does say that significant benefit.
And argue that Saturday, Todd can still differentiate.
Great.
Thanks.
Against that and then maybe David have some additional comments.
If I start with the partnership discussions our mindset not changed here in the SME segment.
We for some time of course have had in formal discussions with a number of <unk>.
<unk> companies.
Im trying to.
Revenues in this market and the way it should go and of course, I think it should be of no surprise to anyone that there's a huge interest in this space as such so so we have had those discussions but we have also been very clear that we didn't want to move onto more complete discussions until we have the next dataset.
So what we're doing from an internal perspective that we set out our organization in all of our <unk> that we can complete the deliver on the <unk> programs and we will move these programs forward.
So as we get data in this quarter. We will also engage in discussions and see when is the right time to find a partner for us.
The right time really will be also defined an issue that we have partners with the right. You can see ambition. We truly believe we have opportunities as I said in my prepared remarks to frame the future of our agency management. We think we see some very unique differentiated assets and we will only partner with somebody who have an <unk>.
<unk> of winning in this space and not just playing in this space. So we actually do you think.
To access a unique and rare situation, we see it in here that we will be you can see really also looking for the commitments from such a partner before.
Defining what time is right for this.
But it's clear to us that there is significant interest as you can imagine.
On the <unk>.
Yes.
Speaker Change: <unk> study remember, it's a smaller study.
I think it's reasonable to expect.
8% to nine and then we are in line with others. As we have said repeatedly percent weight. Those if its lower we would have to look into it that could be static specific reasons for that but I mean, maybe David will provide further comments I will just maybe before I hand over to you David address.
Speaker Change: And mass trial and say.
I think it's pretty well established that weight loss per se related to mass improvements overall.
So of course, you should expect that wait those programs will provide some mesh benefits and potentially also some improvements in fibrosis. As we have said all the time by adding glucagon to two that weight loss program as has been the case with shareholder tied then youll get a liver specific reason to get <unk> out of the data in <unk>.
And thus we would at least expect.
General weight independent benefits on liver and thus significantly higher benefits. So we don't think it will change anything it will just underscore that you can see the potential of indirect weight loss, but it was still you.
Speaker Change: You can say precision the product that is most effective in addressing <unk>.
<unk>.
<unk> future leader because message such issues is going to be such a huge issue with PTC in the future.
David do you want to add something to this.
Ill follow on Adam. Thank you on the <unk> piece I think you are.
Spot on.
While there is evidence.
Our weight dependent effects fatty liver.
The components of mash.
Alluded to targeting the glucagon receptor appropriately.
Proves free fatty acid traffic kingdom metabolism of free fatty acids. So there is a unique mechanism Abbott.
Abbott to we believe wage reducing effects.
Thank you Todd.
At least allow the potential to differentiate from <unk> alone. So I think if.
There is significant improvement with weight reduction with GOP ones. That's a positive for the entire class and then having.
If you will that second signal.
Case that would be on the signal with <unk>.
Ken and potentially will.
Offer additional benefits over and above.
Benefits associated purely with weight change.
And I'll go back to Adam's comment.
Petroleum type program, and what we would expect or at least are anticipating.
And refer you back to the early data with 5% weight loss over short exposures.
Speaker Change: I think 7% to 9% if we see.
Reductions in that range that is entirely consistent with what has been reported with other MLM agonists.
Power with shorter studies, meaning these 12 to 16 week studies.
Weight loss with GOP, one associated or GOP, one based therapies.
Similarly, I think.
What's the pattern of weight loss, what we see differentiation in doses, which is important to inform phase III really is as important as the absolute number but given what we've seen previously anticipating something in that 7% to 9% range.
For us would fit with how we have modeled this.
Going forward.
That's great. Thank you.
Thank you Laura.
Thank you.
Speaker Change: We will take our next question.
Your next question comes from the line of Susan Vattenfall Susan from CLK. Please go ahead. Your line is open.
Hi, there this is Dan from Kimpton, Thanks for taking my question.
I have one more on the upcoming petroleum side readout can you elaborate on the considerations around certain baseline characteristics like BMI and gender split well, what we should be keeping in mind when interpreting weightless data.
And to what extent will there be information provided on the samples baseline characteristics in the top line.
Great.
Thank you for the question is and again I would just that by putting a few comments and then David you can add.
Of course, it's known especially in phase III programs that both based on characteristics agenda.
David: Amount of you can say the base weight and so on are quite significant.
You can say determines how much weight goals you can achieve.
Speaker Change: But so is other things related to how you guide the patients and so on so that so many things you could answer your trial design when you move into phase II, <unk>, which we have not implemented in a study like this.
But I think it's a fair assumption that these are healthy.
Overweight to obese individuals so we have not been.
Can say specifically pushing to get the most of these patients into a study that is so so.
And if that is what your question is about David do you want to add something.
Speaker Change: Happy to have yes.
Nice to hear from you.
The remainder is a relatively small study.
Chris Tiktaalik gender.
The baseline weight, so as Adam said these are otherwise healthy overweight and obese individuals.
And while we will obviously ups.
This time or at a future scientific presentation go through those data in detail I think for US what's critical with the initial readout is looking at.
Speaker Change: The impact on body weight by dose.
Titration scheme may have taught us obviously.
Primary measure in phase, one I'm looking at safety and Tolerability.
As carefully as possible.
So.
This would more than likely be more.
Homogeneous population.
We'll share those data on both the top line.
Future presentations as appropriate.
Thanks.
Got it and then one follow up.
Speaker Change: Can you clarify the number of dosing cohorts.
Our part of the.
Speaker Change: Part two of the Mad study.
David.
Yes.
Haven't disclosed the full number of cohorts.
Speaker Change: Note that there are multiple cohorts.
It allowed us to.
<unk> progress and modify the dosing regimen to get to these so called Suzanne until we have top lines substantially higher doses, but.
This is not a single cohort study we're looking at obviously.
Speaker Change: Significantly higher doses across multiple cohorts.
Got it thank you.
Okay.
Thanks, so much. Thank you that seems to be no further questions I would like to hand back for closing remarks.
Thank you and with that we would like to thank you all for attending and for your questions. We look forward to future announcements and updates and to connecting in the coming weeks and months.
This concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
Speaker Change: [music].
Okay.
Okay.
[music].