Gubra A S

Thank you for standing by. My name is Cath and I will be your conference operator today. At this time, I would like to welcome everyone to the Gruber earnings release second quarter 2024. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Henrik Blu, CEO. Please go ahead.

Thank you very much, operator. We are very pleased today to be able to present to you the key results and achievements from the first half of this year. So today with me, I'm Henrik Blok, CEO, and I have Christian Borbos, our CFO, and Louise Delvaux, our CSO, and they will help out as we go along. So first, generally, Group Run has a hybrid business model. We are experts, specialists in preclinical services, research services for the metabolic diseases. That's a CRO business. And in that we've built up a core research engine and that engine we can also use for our internal research programs, the discovery and partnership part of the business. So we build a pipeline of programs, we mature them to the right level, and then we seek partnerships typically with pharma or biotech companies who then take these programs further towards the market. It's very high interest right now in the services we deliver, and we are growing in the organization at a high pace. We are now 235 colleagues here at Goobra, and we've seen still a very nice interest from US customers. More than half of our revenue in the service business derives from US customers. we are or have been servicing 15 out of 20 pharma companies in the world and also we are servicing a long range of biotech companies as well so key highlights from the first half of this year first of all we have grown the revenue in the cro business by 34 compared to the same period last year So we were pleased with this high growth rate and recently, yesterday, we were out and adjusting the outlook for the CRO business for the full year based on current trading and the order book and of course the achievements in the first half of the year in the service business. Another great news is that in our DNP part of the business, the AMALYN program, the most advanced, not yet partnered obesity program, our AMALYN program. We managed to enroll the subjects needed for the key cohorts in June this year. So well in accordance with the plan that we laid out long ago for this program. And also we have seen some favorable safety data so far from that trial. And that means that we've actually been able to include the optional cohort five and six, meaning that we can dose at higher levels in that trial. And these cohorts are currently in active trial. Also recently, we received final approval from the British health authorities that we are now able to start multiple ascending dosing in the Amelie program, the MAD part of phase one, and that will be initiated in September this year. Another obesity program, UCM2 for healthy weight loss, We are pushing that forward at speed. We are currently getting a batch produced of the drug substance, meaning we can initiate toxicology testing this year in the programme. Also, from our pipeline, and that's from the second partnership with Berger Ingenheim, early July, We could announce that that molecule from the second partnership has been moved into clinical phase one testing. It's a triple agonist. It's a peptide like all our programs. And we are quite excited that that is in clinical testing now as well. So a whole range of very nice news from this half of We, in our CRO business, we have a focus on metabolic diseases. Goobra started back in 2008 with a focus on diabetes and obesity, and we've continued to be active in these areas also for quite a number of years where, for example, not a lot of companies showed an interest in obesity. Luckily, that has changed, and now the recent growth is is primarily driven by a rise in interest in our obesity services. However, we also see a nice business in our liver models, primarily MASH, and in kidney models, and in a range of other organs, again, generally related to metabolic syndrome and the core focus area for Goober throughout the years. Goobra is a one-stop shop when it comes to preclinical studies. We have all the laboratories in-house. We have the testing facilities. And that means that our customers, when they come to Goobra and place a preclinical study with us, we can deliver a full data package. We can control quality. We can control speed. And that is of high value generally to our customers. And in my opinion, it's probably a One of the reasons why our services are so popular.

Christian. Thank you, Henrik. And just continuing on the CRO business, on the financials. And as Henrik talked about, we had a great first half of the year with revenue growing 34% compared to the same period last year. And that's growth across many disease areas, but the obesity area in particular. so as you know you know the obesity area is getting a lot of attention at the moment and and more projects are tried out and that we can see in our order books as well so again reiterating that goober has been in the obesity space since the company was formed back in 2008 and so it's great to see you know that customers are turning to goober to test their new compounds so with the strong revenue we also deliver very solid earnings and the um EBIT margin was up at 32% in the first half and compared to 27% last year. And along the lines of growing activity, we also increase our labor to accommodate the high activity level. So with that, I'll leave the word over to Luise and the DMP business. Sorry, Henrik.

I'll just continue a little bit here. Now we're diving into the DNP discovery and partnership business and really our pipeline is made of peptide programs. We have a very strong peptide program engine and it's based on our Streamline platform and really means that we are able to generate clinical candidates at speed. So using this platform we optimize for civil parameters in parallel and that means that we can actually speed up the development of peptides which with using historical methods to be two to three years and now we can do it in around one year so really this streamland platform is key in the build up of our pipeline And here we see the Gubro pipeline, the top four programs here, all obesity programs. They are partnered with Graham Ingelheim. And as mentioned, we saw the first one enter clinical testing quite some time ago. And now also recently, the second one entered clinical testing. So very positive development there. We also have a collaboration with HEMA that's within bleeding disorders. So this program or this collaboration is really the part that Gubra is delivering. That's the key insights in developing peptides, whereas HEMA is bringing insights to the disorder to the table. At Gubra, we don't know too much about bleeding disorders, but luckily our partner is doing that. We have a range of unpartnered programs, all the green ones and the most progressed, the Ameline program. It's in the clinic now. We have the UCM2 program heading towards the clinic. And as you can see, we have a range of other more early stage programs which are not yet partnered. So diving a little more into the programs, Louise, please take us through that.

Yeah, sure. So now to group AMI, where we're very pleased with the recent development here. But let me just start by giving a short introduction to amylin and explain why we're really excited about this acid and see a key competitive edge here. So amylin is a native peptide hormone. It's produced in the pancreas and co-secreted with the insulin from the beta cell and it's well established that amylin plays a very important role in the energy regulation. Clinical data has also shown that amylin can facilitate clinically relevant weight loss. Importantly, amylin is not an incutin. It activates different receptors and mediates the effects by a complementary and distinct mechanism of action compared to geoprimone. This also means that there's a huge combination potential of combining GLP-1 and amlin. At GUPA, we have designed a long-acting amlin analogue, GUPAMI, which has been designed for once-weekly subcutaneously administration. GUPAMI has been engineered to have excellent pharmaceutical properties at neutral pH. This means that we can co-formulate it with other anti-obesity agents out there. The weight-lowering potential of amylin is also reflected with Goop Ami, shown here in obese rats. You can see that Goop Ami by itself facilitates a very nice weight loss. You can also appreciate that when we combine it with other anti-obesity agents, we see a very nice additive effect, again highlighting the competitive ETF with amylin. So amylin is now currently in a phase one clinical study. Here again, in a phase one study, primary objective is safety and tolerability. There are some key news that I want to highlight from this study. So first of all, we have completed dosing as planned of the first four cohort. Here we have observed a favorable safety profile, and this has allowed us to extend into the two optional higher dose cohorts. The last cohort here will be dosed in August. This also means that we now expect sublime results late 2024. So we're also very excited to announce that we have obtained regulatory approval to continue with the multiple ascending dose study. The study will be conducted at the same site in Nottingham as the single ascending dose trial. We expect to have completed dosing of the 52 participants by the end of Q4 2025. So moving on now to another very exciting asset in our pipeline. This program builds on a new mechanism. Here we're using long-acting UCN2 analogs to induce a muscle sparing weight loss. But let's just take a step back first. I want to explain why we believe that we can be competitive with this asset in the highly competitive obesity market that we have today. Because it is well established that current weight loss therapy induce substantial weight loss. It's also acknowledged that lean mass accounts for 20 to 40% of the weight loss. And lean mass, that's muscle and it's bones. Therefore, we think it's time now to focus on the quality of the weight loss and not just the quantity. By this, we mean that we want to maximize loss of fat mass while preserving or even increasing the lean mass. And then we also want potential cardiovenial upside. In preclinical animal models, we have shown that we can obtain all this with a UCM2 analog, which holds potential to become the next generation of anti-obesity therapy. So we have designed a very nice molecule here. It has a selective receptive profile, and it has excellent formulation properties at neutral pH. The pharmacokinetic profile in animals supports a once-weekly dosing profile in humans. If we just look at data here obtained in obese rats, you can see that by itself, UCM2 doesn't induce a lot of change in the body weight. However, when we start to look at the body composition, it becomes really interesting. Here you can see that the UCN2 analog increases the lean mass while decreasing the fat mass. So basically you can say that we're turning fat into muscles. You can also appreciate that the other anti-obesity agents such as semaglutide induces both fat mass and lean mass reduction. What is really exciting here is that when we combine UCN2 with, for example, semaglutide, we can completely prevent the lean mass loss and we can drive the fat mass loss even further. We are currently planning for a clinical study with the UCN2. We have just initiated the API reduction, which allows us to initiate non-clinical talks later this year. This also allows us to plan for a phase one clinical study to start late 25, early 26. And finally just here some updates on our second collaboration with Behringer Ingelheim. Here we have developed a triple agonist first in class for the treatment of obesity and Behringer is now so responsible for advancing this program. We are very happy that Behringer has decided to move this acid into a phase 1 clinical study. This was recently disclosed in a joint press release. The study is designed as a typical phase 1 study, starting with a single ascending dose, followed by a multiple ascending dose. They expect to have the participant finalized by the second half of 2025. Moving on to you, Christian.

Thank you, Louise. And just a few words about the financials of the Discovery Partnership business. So we have a bit lower revenue. But please remember, as Louise talked about, in the BI second collaboration, we received a milestone that occurred in July. So that will feature in our accounts in Q3 this year. You'll see a little bit higher costs and that is fully anticipated as we now run several projects in parallel and move them forward. With that, I just round off with a very strong note on our guidance, which we raised yesterday for this CRO business. So now we expect growth for the revenue of 23 to 28%. And we also raised our EBIT margin slightly. Please also remember that we are accommodating the high activity by adding more manpower to satisfy the customer demand. All in all, a very good first half and upgraded guidance for the CRO business and also significant progress across our DMP business. That concludes our presentation. And operator, now we open up for questions.

Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. If you are called upon to ask a question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not in mute when asking your question. Again, press star one to join the queue. Your first question comes from the line of Laetitia Weary with Kempin. Your line is open.

Yes, thank you for the presentation. Maybe on the MLN development, could you elaborate on what you have seen so far in Phase 1 and why you decided to add the high-dose cohorts? And also at what dose level will you start the MAD and does that overlap with the SAD?

Yeah, sure. So what we're disclosing for now is that we see a nice safety profile for now. which has of course allowed us to extend the study with the two optional dosing cohorts. So for now we are not disclosing the doses which we will start the multiple ascending doses trial with.

We can see the reason why it's favorable to be able to go to the higher dose groups is of course to establish the safety profile when you dose at higher levels. And being able to dose at higher levels Of course, it gives us more ways of freedom to use this drug candidate later on and perhaps even increase the weight loss or whatever if you can dose at higher levels. So I think it's a super positive thing that we are able to dose at higher levels based on the data we saw from the first four cohorts.

Okay, thank you. And maybe, do you have any indication on what proportion of male and female you expect to include?

So, in the MAD study, it's open for both males and females, but at this point in time, we cannot disclose a ratio between sexes participating in this trial.

Okay, thank you.

Any further questions, operator? Otherwise, we have some questions in writing here that we can take.

There are no further questions at this time.

Okay. Then I'll take a few questions and there are two from SEB Martin Parkboy. And the first question is asking about the CRO growth and why it was in actual terms a bit lower revenue compared to the first quarter. So essentially the activity level is as high in Q2 as in Q1. So we don't see a decline in the activity level. Sometimes when you sell studies, if they're larger studies and you sell them at the end of a quarter, then you have not performed so much on the studies, meaning that revenue will be recognized in a subsequent quarter. So my main message here is that we see as good activity in Q2 as it was in Q1 in our order books. And again, the important message is also that we raised guidance yesterday for the full year. This was a second question from Martin also that on the BI collaboration one with the triple agonist, there's a question why we classify it as first in class.

Yeah, I think it's actually a question to the BI collaboration number two, which we recently could announce was taken into clinical phase one. And it's triple agonist. So that so much is public right now. And why is it a first in class? And it of course has to do with the sort of the combination of targets that's being addressed using this molecule. That's why it's called a first in class. But again, the program is with BI and further questions into the program has to be addressed to BI.

Right, and we have two questions from gentleman Kim Nielsen here. So asking when we expect to present phase one data, could it be at the conference later this year?

Yeah, and I can just say that we do plan to present the data from the single ascending dose trial data this year, but we haven't decided where we will present the data yet.

Then another question from the same gentleman was also regarding, you know, the half-life of obesity drugs, whether it could be extended to, you know, once monthly dosing and if Gubra's platform is able to, you know, make that change to a longer half-life.

Yeah, very relevant question. I can say that we are constantly developing and optimizing our Streamline platform, and we are also looking into opportunities for achieving a once-monthly dosing profile.

That was the questions from the Q&A. Operator, are there any other questions from the phone?

I do not show any questions at the moment. That concludes our Q&A session. I will now turn, oh, my apologies. There is another question following up from the line of Lake Tishawari with Campen. Your line is open, ma'am.

Yes, thank you. Maybe more on the CRO segment. What trends do you see in the wider CRO space, apart from, of course, the obesity momentum? And what makes you perfectly positioned to thrive on these trends?

Sorry, could you please repeat the questions? The line was breaking up a little bit.

Of course. On the CRO segment, what trends do you see in the wider CRO space apart from the obesity momentum? And what makes you perfectly positioned to thrive on these trends?

So for general trends, I'd say we see a lot of companies testing compounds in obesity, maybe compounds that has been in development for other metabolic diseases. They're being tested for their potential as obesity treatments. That's a strong trend. Also, we see a trend or an interest in what else apart from weight loss, could a therapy be driving? Do we see improved parameters on liver or on kidney or things like that? I think there's a strong interest in that as well. We also see interest in in our brain studies. So how are these various therapies working? What sensors are being activated in the brain? You may recall that Gubra has a very sophisticated 3D imaging platform where we can actually assess activation of brain centers following a given treatment. and that is of interest as well and we see it gradually and i think it build up and understanding why is the brain so important in various metabolic diseases in appetite regulation and so on um for in general if if the second part of your question was how do we um use this knowledge of trends to prepare guber for the future uh we we do see these uh these interest shifting into at some point in time, some years back, there was a lot of attention on MASH, so the liver models that we deliver. These days, there's a lot of interest in the obesity models that we deliver. And then what would be the next thing following obesity? Because I think none of these trends will last forever. So we're trying to ensure that we have a broad portfolio of of preclinical models related to various metabolic dysfunctions and thereby ensuring that we are ready whenever the focus of the industry is shifting around. So we are constantly building our catalogue of models and we are constantly refining the models that we are using. I hope that was answering to your question.

Yes, perfect.

Thank you so much. Again, if you would like to ask a question, press star one on your telephone keypad. Currently, I do not show any question on the queue. I will turn the call back to management for closing remarks.

And all that remains to be said is thank you very much for listening in. It's been a pleasure to present this morning and to answer questions. And we're looking forward to next time we are presenting. Thank you very much.

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.