Gubra A/S (GUBRA) Earnings Call Transcript & Summary

Thank you. Thank you. Thank you. Good afternoon, everybody. Thank you for everybody attending and listening to this discussion today with Gubra. My name is Kayla McGurk. I'm a member of the investment banking team at Morgan Stanley. Just before we get started, like other sessions at our conference there are some important disclosures for which you'll need to refer to the Morgan Stanley disclosure research website www.morganstanley.com research disclosures, and if you have any further questions please reach out to your Morgan Stanley sales representative. I'm not sure how much outreach we get on the disclosures, but just for good measure. So, Markus, it's a pleasure to have not Gubra for the first time, but you for the first time attending our conference in New York.

We were just discussing, it's effectively your 1-year anniversary at Gubra. You know, maybe, and we'll talk a little bit about who Gubra is today, but maybe just 1 or 2 minutes on your background, what attracted you to join this company? And then we've got lots of interesting topics to cover.

Well, thank you very much for inviting me, Kayla. It's a real pleasure to be here. I have a research background. I'm a scientist, a structural biologist. I spent many years in pharmaceutical research and management, more recently more in the biotech environment before I joined Gubra. What attracted me to Gubra was essentially seeing a unique opportunity to grow a company forward. Gubra has tremendous potential, and it's about realizing this potential and also with a great team and a great board, so I got immediately attracted to the opportunity and after 12 months I can really say Gubra is a unique place.

And it is a unique company and for those listening who may be a little bit more or less familiar, how would you describe Gubra today in terms of, you know, what the company, who you are, what your core competencies are, and, you know, as you joined and were excited about the opportunity, where you see the most potential for value creation going forward?

Yes, in a simple concept, Gubra is a clinical stage bioscience company with a unique business model. We have three units: a biotech unit which discovers and develops novel peptide therapeutics to clinical proof of concept. At this stage, we would partner those assets with pharmaceutical companies. Our discovery platform is validated. We have multiple assets in the clinic. Our partner and business model is validated based on the series of partnership deals the company has done. On top of this, we have a very successful CRO serving external customers, but being an integral part of our innovation platform. And on top of that, we now have a new unit, Gubra Ventures, which enables us to invest our capabilities into high quality science adjacent to our core therapeutic areas. So overall, I see the vast majority of value growth biotech pipeline and that is also our focus.

We've had a couple of your partners also attending our conference. For those that are less familiar, you've been very successful in terms of the early development and collaborations that you've struck on the obesity side. You have two phase 2 assets with two very, you know, well-known and well-respected companies being AbbVie and obviously Boehringer Ingelheim. What, you know, what does that tell you, the audience and us, about, you know, Gubra's competence and capabilities. And we'll start in the obesity field because that's obviously very large and important. And certainly you've seen, you know, two of these programs announced to progress in the very recent months.

Yes, I think I can talk a little bit about how the obesity market is developing and how this is reflected in our pipeline. So the obesity market has grown tremendously, and the field has advanced tremendously. Initially, it was about demonstrating a clinical a reasonable loss of weight, how much weight can you lose in a period of time. Now it's more about complementary and additional mode of action which has the promise to deliver additional efficacy, tolerability, or also to particular patient populations. There is additional focus on body composition and muscle health outcomes. And we also believe that combination therapy will be very important to deliver specific to the needs of certain patient populations. So, and if you look at those three areas, I think that is clearly reflected in our current pipeline. We see GGG triple partnered with Boehringer, we see Amylin partnered with AbbVie, and also our own use of the long-acting urocortin-2 agonist.

We want to cover all three of those. Maybe we'll start because AbbVie recently announced their intention to progress. It's now called ABBV-295. It had a different name when I remember when you did the deal, you know, they've signaled that they're moving that forward. You know, it's an Amylin as you will go into, as you talked about your view on the evolution of the obesity treatment paradigm, what role do you foresee for Amylin broadly and then obviously ABBV-295? And then after that we'll talk about some of the next steps and updates from your partner on that program. Yes, great.

I think for the class, the Amylin class has already shown promising clinical efficacy. I see a favorable tolerability and safety profile and potentially also an opportunity for longer treatment cycles, right? So, I think if I look now at ABBV-295 particularly, we have seen great phase 1 data, top line data this year, where the compound demonstrated about 10% weight loss in a period of 12 to 13 weeks, and taking a look at the patient population, which was like 88% male and also with a BMI on average around 30, this is actually very meaningful weight loss data and I think that is very, very promising. And on top of that, the compound achieved similar weight loss, this biweekly or monthly, administration so I think it's a maybe it's going to be a great profile. And there's some important next steps there on.

ABBV-295, I think they've talked about presentation at EASD. Relative to the data that's been put out into the public domain, is there anything, you know, that you can share in terms of what that update may be, you know, what that patient population may look like relative to, you know, the data from earlier this year?

Yes, I think we have seen the top line data. There will be a fuller data set. We get nuances on efficacy and on also on the safety and the tolerability profile. So that will be important to understand the drug in the full context of this trial. On top of that, there is phase 1b trial up is running in the U.S. in a more representative study population with BMI between 30 and 45. There's also much larger portion of female study participants and this trial runs a little bit longer, 20 weeks. So I think that was going to be a very important data set to inform the further development of the drug on top of, of course, the ongoing phase 2 trial. But I think taking together those two trials, that will give us a good indication on how this particular compound will translate into clinical efficacy and safety.

Maybe one more last question on ABBV-295. Obviously with the very intriguing data that has come out in relation to the broader Amylin class, there's some debates about DACRAs versus selective, you know, where do you, based on, you know, the work that you had done at Gubra, think that the collaboration that you have with AbbVie has the potential to differentiate versus other approaches that are out there.

Yes, I think at the moment that would be speculation. Okay. And I probably don't want to go there. What we know for sure is that we have a very long-acting molecule with proven efficacy and I think the ongoing trials will definitely show what the profile of the drug will be.

Should we maybe change tack to the other phase 2 program that you have with one of your partners, Boehringer Ingelheim? In the era and with all of the excitement about triples. This is also a triple, but a slightly different triple. So maybe talk about the sort of target selection there and, you know, the NPY2 biology. Yes.

So a different triple but equally exciting. Yes. So the concept behind this, basically to combine the well-established incretin biology with a central regulator of food intake, an anti-biotic. And taking together, you double down on food intake, and that should provide the basis, the fundamental basis demonstrate deeper and more durable weight loss. So that's basically the concept behind it and phase 2 has now started and so, hopefully this exciting complementary mechanism will show great clinical efficacy and safety give us an indication on the positioning of the drug.

More importantly, or as importantly, moving on to your third, you probably have more, but at least the next most advanced obesity program at Gubra, which is against a very exciting new target area of biology, which is UCN2. So, you know, you've made great progress here. I think there's, you know, we've seen some activity very recently in the UCN2 space. What makes you excited about the target and maybe link that back to, you know, some of the trends that you foresee in obesity and where the remaining unmet need is.

So our long-acting Urocortin-2 agonist has exciting biology, you know, preservation of muscle and muscle health is becoming a more important topic. Substantially lose weight you not only lose fat mass but you also lose lean mass and a part of that is skeletal muscle. Skeletal muscle is very important and it is a determinant of physical function and mobility and the metabolic health and also. So for the elderly population, the maintenance of muscle mass and function is super critical. So I think this is exactly where UCN2 comes in. In preclinical studies we have demonstrated substantial reduction of fat mass and at the same time UCN2 prevent the loss of lean mass and even to some extent increases lean body mass. So I think this is a very promising. And in our ongoing phase 1/2A trial, we use this in a comprehensive way to explore the biology both as a monocompound but also in combination with incretin-based therapies for myeloma. Maximum impact for patients in different populations. So the trial is quite exciting, a lot with the classical SAD trial in a healthy population followed by an MAD trial in overweight and obese patients for 6 weeks of treatment with multiple doses. Where we have 16 weeks of treatment with multiple doses as a monotherapy and in combination. So the overall package, on the 2A study plus our preclinical studies evidence in totality will be a very rich data set. So we are very excited about this compound. Now moving into obesity is sort of the clear first step, but we believe there is substantially more potential beyond obesity in areas where muscle health and muscle function is important, it will also have substantial commercial potential. So that's an exciting area for us where we will invest significantly going forward. I think you mentioned the recent deal between Genentech and Hanmi. Obviously, that is very exciting to see because it validates the potential of the biology. Pharma Company has made a strategic move into the field. We of course welcome additional science into the field. We are among the front runners on the UCN2 biology. And I mean, we as a company, we have made a deliberate decision not to partner UCN2 and to complete our phase 2A program to maximize the potential of the asset for Gubra when we partner.

One last question and we'll move on to some of the other business areas outside of Western management and obesity. Perhaps it's still early days as you say you've seen validation of the approach through the recent deal between Hanmi and Genentech. As you sort of scan the competitive landscape for your cohort, do you think there's likely to be differences as we've seen in the sort of GLP-1 space or more similar than different and it's going to boil down to the quality of the package and the quality of the development or possibly just too soon to tell?

Yes, it's a little bit too soon because there is no clinical data published on any of those compounds. Yes. I think the field is getting more competitive as more people realize the value of the biology. I think we certainly have focused on the quality of our package. And I think this is how, for Gubra at least, that is the best way to deliver high quality to a potential partner.

Moving on maybe to just sort of more broadly where Gubra sort of sees the opportunity from a development standpoint. Your legacy and strength has clearly been in weight management, metabolic disease, clearly validated by the partners that you've attracted, but I think you're increasingly talking about the potential and the interest of Gubra as being more agnostic around therapy area. How should we sort of think about your intention or ambitions to move out of obesity into other areas?