Gubra A S

So good morning and welcome to this quarterly update call from Goobra. I'm Henrik Rom. I'm the CEO of Goobra. So are we running? Seems like we are. So with me today, I have our CSO, Luise Estadbø and Christian Borbras. So... Gubra has a hybrid business model. We are experts in preclinical research within metabolic and fibrotic diseases. And over the years, we've built a core research engine. We have all the laboratories, all the test facilities and all the technologies needed to conduct these preclinical research studies. And we use this core engine to deliver or to progress our own pipeline programs. That's the discovery and partnership business. And also to deliver services to external clients, could be small biotechs and large pharma companies. We have a whole range of customers and we're actually serving 16 out of top 20 pharma companies in the world. And also, as mentioned, a range of smaller pharma companies and biotech companies as well. So today we are approximately 250 colleagues here at Gubra all gathered at one site in north of Copenhagen, Denmark. However, we also have a sales office in Boston as we have more than half of our revenue in the service business from customers located in the United States. and recent highlights we continue to show strong progress across uber so our amelin program has progressed nicely in this quarter we have completed the sad part of the program the two optional cohorts were dosed in july and august follow-up visits continued until early october and We are now expecting to release data from this part of the phase one trial later this November. Also, we were able to start up the multiple ascending dose part of the study and the dosing started in September, so a couple of months back. Our high quality weight loss program, the UCM2 program, we've also progressed and we are planning for entering this program into the clinic late next year or early 2026 and yes that program is also progressing at plan as planned we have four collaborations with bernie engelheim but we've also seen some development this quarter here so in july we could announce that Collaboration number two, a new in class triple agonist for anti-obesity treatment was started in a phase one clinical trial. And a few days back, we also announced to the market that Böhringer has told us that they will discontinue the clinical development of this collaboration number one, the NPY2 agonist. No further data available at this point in time. However, we will communicate as soon as we know the future of this program. In this quarter, we continue to see strong growth in our service business. And looking at the first nine months of the year, we've seen growing by 31% compared to the same period last year. So all in all, a very satisfactory third quarter of the year. To dive a little bit more into Grubrush core business, We've been working with metabolic and fibrotic diseases since 2008. And it started out with a key focus on diabetes and obesity. And since then, we've gradually moved into other disease areas, all in one way shape or form related to the original onset of our scientific focus. So we are quite active in the mass space, quite active in the kidney space. We have also models in the lung space with regards to CVD, intestines, the brain and so on. So a quite sophisticated set up of models where we are either to external clients or to the internal pipeline programs. And that means because we control all the parts of these studies that we are controlling quality, we're controlling speed, and that is of high value both to ourselves when we are maturing our programs, but also to our clients throughout the world.

Thank you, Henrik. And as I said, you know, we had a great start to the year and the first nine months we're up in revenue for the CRO business by a little bit more than 30%. The main drivers has been the same as we've seen in the previous course, obesity, but we also see a good take up within our kidney services. So all in all, you know, a great 2024. And of course, the obesity space, the momentum is substantial, and Guber has been in this space since the company was formed in 2018, and we're really benefiting from new compounds being tested in our models. And with the strong revenue, we also deliver very solid earnings and EBIT was up by 55% compared to the same period last year for the first nine months. And we also have an EBIT margin in the area of plus 30%, so 33% for the first nine months and 35% for the quarter in isolation. All in all, this sound and very good development we've seen in the first two quarters continued in the third quarter, and all in all, a very satisfactory performance throughout the 24.

Great. Thank you, Christian. now we are looking into the pipeline of gubra all our pipeline programs are based on peptides and we have the streamline peptide platform as a as sort of the foundation underneath our pipeline we have built this platform it's ai assisted discovery of peptides and and we can use this platform to to deliver clinical candidates at a much higher speed than we were previously capable of doing prior to developing this platform. So it really comes down to using AI to guide our peptide development, to guide the design of the peptides, to do a systematic variation all throughout the back backbone of the peptide and thereby in parallel being able to optimize for several parameters such as potency and selectivity and physical stability and chemical stability and so on. So using this platform, we have developed these 11 pipeline programs. The top four here are in collaboration with Böhringer Ingelheim. And you may recognize the small asterisk for the top program saying here that this has been discontinued by Böhringer. And as mentioned, we are awaiting further information before we can reveal more info about this program going forward. We also have a collaboration program with HEMA, biotech company that's within bleeding disorders. And then we have a range of unpartnered programs. Six of these are on this pipeline. Four of them are within obesity. The most progressed one is our group amylin program. Again, we will be able to release SAD data later this month. We are eagerly awaiting that. We also see the UCM2 high quality weight loss program. And as mentioned, a range of other programs here in the pipeline. But now let's dive into some of these programs. And Luise, please go ahead here.

Yes, definitely. So now to Group Amlin, an Amlin program where we're very pleased with the recent developments. But let me just start by giving a short introduction to Amlin and explain why we're really excited about this asset and see a key competitive edge here. So amylin is an endogenous peptide hormone that is released from the pancreatic beta source. And it's well established that amylin biology plays an important role in appetite regulation. Amylin agonism has also been shown to facilitate a clinically relevant weight loss. Importantly, amylin is not an incretin. It activates a different set of receptors and mediates the effect by complementary and distinct mechanisms of action compared to GLP-1. This means that there is a substantial potential of combining amylin and GLP-1-based treatment. At GUBRA, we have developed a long-acting amylin analogue, GUB-amy. It has been designed to be compatible with once-weekly subcutaneously dosing in humans. Gupami has a similar receptor potency on the amylin and calcitonin receptors as native amylin. Importantly, Gupami has been designed to be chemically and physically stable at neutral pH. This allows co-formulation with other anti-obesity compounds. So the weight-lowing potential of amyloid is also reflected with group AMI. This is clearly shown here in a study conducted in diet-induced obese rats. Here you can see that amyloid by itself induces a very nice body weight reduction. You can also appreciate, once we combine it with an incretin-based therapy, we see a very nice additive weight loss, again highlighting the competitive edge here of amyloid. SOGGROUP AMI is currently being tested in a clinical phase one study. The primary objective here is safety and tolerability. As also reported previously, the key highlights from the SAD study here, we have from the first four cohort seen a favorable safety profile. This allowed us to extend to also include the two higher dose optional dosing cohort. we completed the last cohort cohort 6 in august this means that we are very much looking forward to present top line resource this month additionally we simultaneously started up the multiple ascending dose trial this study is being conducted at the same research site in nothingham as the sad trial we expect to have completed enrollment of the 52 participants by the end of next year So moving on to another very exciting program in a pipeline, and this program builds a new mechanism where we're using long acting UCM2 analogs to induce a muscle sparing weight loss. And this is interesting because if we just take a step back, I want to explain why this asset will be competitive in the highly competitive obesity market that we have today. Because although it is well established that with current weight loss strategies, patients look substantial of weight, it's also established that 20 to 40% of the weight loss is lean mass. And lean mass, it's muscles and it's bones. Therefore, we think it's time now to focus on the quality of the weight loss rather than just the quantity. By this, we mean we want to maximize the loss of fat mass while preserving or even increasing lean mass. And then we also want to see a potential cardiovenial upside. In preclinical animal models, we have shown that we can obtain all this with a long-acting UCN2 analog, which holds potential to become the next generation of anti-obesity pharmacotherapy. so we have designed a very nice molecule here it has a selective receptor profile and it has excellent physical and chemical properties additionally elementary scaling using data from mice rats and mini pigs supports a once weekly dosing profile in humans so if we look at the data here conducted in a study again in diet induced obese rats You can see that by itself, UCN2 doesn't do much on body weight. However, when we start to look at the body composition, that's when it gets interesting. You can see that UCN2 substantially increases lean mass and decreases fat mass. Basically, you can say that we're converting fat into muscles. You can also appreciate that other weight-loss strategies, such as somatotype, decrease both fat and lean mass. So when it starts to get really exciting is when we combine UCN2 with compounds such as semaglutide. You can see that we can completely eliminate the lean mass loss induced by semaglutide and other obesity agents, and we can drive the fat mass loss even further. So we are planning for a clinical testing with a UCN2 analog. We have initiated API production and plan to start the non-clinical tax program later this year. This allows us to plan for a phase one study to be initiated late 25, early 26. So moving on to updates on the clinical obesity collaboration projects with Bjørn Engelheim. So, as previously mentioned, we have developed a first-in-class triple agonist peptide for treatment of obesity. And Bøhringer is responsible for the further development. This project reached a significant milestone in July with the initiation of the phase one study. And the study is designed as a typical phase one study, starting with a single ascending dose, followed by a multiple ascending dose pathway. Study completion is expected the second half of 2025. Additionally, Berger Ingelheim has decided to discontinue the development of the long-acting Y2 receptor agonist program. So we do not have additional information right now, but as Henrik also alluded on, we will communicate once we know more.

Thank you, Lisa, and just a few words on the financials for the D&P segment. And we see an increased revenue in the first half and also the Q3 in isolation. That's partly due to milestone payments from collaboration partners. We also see increased cost within this business segment, and that's very natural as we are moving a number of projects forward in parallel, not least the Ameline, where we also run the MAD study now. Let me just round off with the financial outlook for 2024. We have narrowed the outlook for the CRO business segment and move it upwards. So now we expect growth of the revenue goal for the CRO business of 26% to 28%. Previously, we expected 23% to 28%. And similarly for EBIT margin, we've also... narrowed upwards our expectations now being 30 to 32 percent for the youth margin compared to 29 to 32. so a slight improvement there all other outlook parameters are being kept unchanged with that we conclude our presentation and now we open up for questions operator please we are now opening the floor for question and answer session

If you'd like to ask a question, please press star one. Your first question comes from Martin Parkway from SEB. Your line is now open. We will move on to the next question. Our next question is Morten Larsen from ABG. Your line is now open.

Hey, guys. Morten here from ABG. A couple of questions from my side. First of all, you provide us with FTE count, and that continues to move up. Can you talk about how we should think about that, if your ability to continue to drive that FTE into 2025 as a support for the organic revenue growth in the CRO business and how we should think about that. I wouldn't call it disconnect, but between the midterm guidance of 10% annual growth versus the growth that you are, super growth you're seeing now. That's the first. And the second on the discovery and partnership, you continue to put a lot of money into this, but we are struggling a little bit with seeing sort of the inflow of revenue of many partnerships being signed. And I was just wondering how you will phrase sort of your continued support for this business to the same extent that you put the money into it right now. Let's start with those two.

Thank you, Morten. I can start out here. So with regards to partnerships, we maintain our guidance for the year. the outlook one to two new partnerships for this year. So you're right. So far, we have not signed a new partnership this year. However, as mentioned, we may see the outlook. So yes, we are investing in our pipeline. We believe that we are to build a massive value here and and driving programs into the clinic. And for what in the clinic is, of course, costly. So that is all part of the plan. And eventually, when we are part of these programs, we will be seeing the fruits of these investments. That I'm quite certain of. With regards to the manning, we have been manning up this year quite a bit. And of course, it has seen in activities that would be both across the service business as well as in the internal pipeline programs. So it's quite natural. I think we received some very good influx of talent and experience, which is needed for what we've been through this year. So going forward, we will be, of course, eventually presenting the outlook for next year. And in that point in time, we will also include our estimates, of course, for when we do the budget for the manning development next year.

Thank you. I have two more, but I should step back in line.

Your next question comes from Martin Parkway from SEB. Your line is now.

Martin, thank you, SEB. I will try again. It was a little bit of a long line, so I forgot to unmute. Just back on a couple of questions on the partner income that you have booked, I guess, milestone income that you booked in Q3, I guess, related to the phase one initiation of the critical agonist. This milestone you get for this change, is that solely booked in Q3, or could you also see some additional from that spread to Q4? And then just to come back on Morten's question, so as I hear you, that we will get partnership more with it before the end of this year at least. And then a third question is just on the on the very soon upcoming data from the single ascending dose study. Can you talk a little bit about how much you will reveal in these headline data? Will we get short-term efficacy data and what kind of headline numbers should we expect?

So let's start out on the milestone question. Christian, please help out.

Yeah, so that is the milestone for this particular event that the assets is being moved to clinical phase one. So in isolation, we will not expect for that particular event to generate additional milestones in Q4. But we, of course, have the potential for additional milestones as the program moves along.

Then you had a question with regards to another partnership this year. And yes, we maintain our outlook for the year one to two new partnerships. And as we have not signed any new partnerships this year, that of course means that we are still anticipating to sign one to two new partnerships in the remainder of the year. So in the next couple of months. And then you have questions with regards to the SAD data and Louise, would you comment on that part?

Yeah, definitely. So as also mentioned, we are looking forward to present the SAD data this month. Again, the key focus on the study is safety and tolerability. But of course, we will also be showing some target engagement biomarkers.

So Martin, to that question, there will of course be information about adverse events, and also the key elements describing early target engagement. So weight data, as you are asking to, is part of that, yes.

Okay, thank you.

Your next question comes from Leticia Wehre from Kempten. Your line is now open. Leticia, if you'd like to ask a question, please press star one on your telephone keypad. Again, that's star one on your telephone keypad. Your next question comes from Martin Parkway from SEB. Your line is now open.

Yes, I will continue then. I thought that I should leave the floor to Morten. He saw a lot of questions, but he became shy, apparently. Just some more questions on the Amalan side. What do we actually speak? Because we have a lot of comments out there on potential long-term weight loss on... for the amylin or what we should call it in immunotherapy, what kind of weight loss do you actually think this kind of compound or this kind of one can generate in a long-term phase three trials, just ballpark things? And then another question is that if you look at clinical data from other companies, do you believe that we will see a plateau effect of the amylins earlier than we see on the Gilbrands?

Yeah, so regarding the first question of long-term effects of the amylin, I would say there's a lot of clinical data emerging out there and it's all validating amylin as a very nice target inducing clinically relevant weight loss i think what it will come down to in the end that will be for the larger clinical trials to actually explore and then the yeah i guess you covered both questions here martin do do you have a follow-up comment

I could come with one more follow-up question, then just on the MAE study. I know you have put down the timeline, but are there anything you can do to progress it even faster? Although it would cost you more.

So it's not a matter of cost. We are progressing as fast as possible and part of that exercise is to on a continuous basis analyze, is there anything that we can do in order to speed up the process? So it's an ongoing exercise. And if we see an opportunity for doing that, we will communicate it. For now, we started in September, and we will continue dosing until late next year.

OK, thank you.

Your next question comes from Morten Larsen from ABG. Your line is now.

Thank you for taking my follow ups and happy to hear Martin took so many of those, but a couple of them first on the M&A. We still only have the mini pig M&A. I was wondering if you can talk about your continued appetite and what kind of timelines we may look for the next set of M&A. That's the first one. The second one. I believe I heard you say you're now working with 16 of the top 10 big farmers. Is that another one added here during the quarter? And third, and also back to Martin's question on the partnering, We did see some early indications of the size of the partnership deal that Nordic signed with Livia and the DACRA. Could you talk about how you would see those kind of deal terms versus how you would expect the deal to be structured for your MLM molecule once we get there?

Thanks. All right. Thank you. So, starting from one end with regards to M&A, last year we did buy the mini-gut. the miniPIC facility testing and that we are using. We are, especially for the internal programs at this point in time, however, also we're delivering it as a service. So we continue to investigate and look into M&A opportunities. We have a focused approach is sensor-alarm technologies supporting our activities, could be in the peptide space. within some of the other areas where we are active. But a very focused approach and then we continue to evaluate various opportunities. We are in no hurry and we will strike a deal there once we see something we think is a strategic fit. You are right with regards to the second point. We have now added one more big training part on the client list. So yes, we are now servicing 16 out of top 20 pharma companies in the world, either right now or have been in the past. And then you had a third question and that, oh yeah, that was with regards to structure for potential collaboration, sorry, on the Group AMI. We have not disclosed any details here with regards to what kind of deal that we are pursuing. We are continuously discussing with various parties. We have an opportunistic approach. And when we think the right deal terms are on the table, we will strike a collaboration deal for that program.

Follow up to that, Henrik. Are you saying you are discussing deal terms with a potential partner? Or did I mishear you?

At all times, we are discussing our various pipeline programs with various potential partners. And we also, for the Ami program, continue to keep relevant parties updated So I'm not sort of disclosing any news here. I'm just saying that we at all times are having an opportunity to ensure that the potential partners are informed and eventually when the right deal terms are on the table, we will strike a deal.

Maybe just to follow up on that, when would you expect a partner to be more interested in partnering? Do we need to await the MAD trial first? Is that what you hear from your partners, potential partners?

So a deal could be based on SAD data, could be based on MAD data, could be when in a phase two. So our strategy is that we go, when Gruber goes no further than phase two, But it could be very well that we are striking a deal prior to that. So I think that's in line with what we've communicated previously. So I'll stay to that.

That's great. Thanks, guys.

Your next question comes from Leticia Weary from Kempen. Your line is now open.

Hi, can you hear me? Yes. Perfect. Sorry for the drop off last time. Sorry if I missed it, but could you provide more color on the NPY BI discontinuation? And also, if you could provide your view on the future of the asset going forward, will you develop this in-house to generate more data and pursue a new partnership? Or what is the future of the asset? Thank you.

So at this point in time, we are gathering data, information, and eventually we will communicate what the plans are going forward. But for now, we can only communicate that Great-Inglheim has decided to not pursue it further into the clinic. And then later on, we will have more information, more clarity, and then we will communicate.

That's all that we have for our conference questions. I'd now like to hand back over to the Gruber team for further remarks.

Okay, thank you very much for all the questions and also thanks for participating and we hopefully speak again soon, not least when we have the next quarterly results. Thank you very much and have a good day.

Thank you for attending today's call. You may now disconnect. Have a wonderful day.