Avalo Therapeutics, Inc. Common Stock 12th Annual Cantor Fitzgerald Global Healthcare Conference

Good day, everyone. Welcome to day 2 of Cantor's Global Healthcare Conference. I'm Prakhar Agrawal, a biotech analyst at Cantor, and for our next session, we are very excited to host the team of Avalo Therapeutics. From Avalo, pleasure to have Garry Neil, Chief Executive Officer. Garry, welcome, and thank you for coming.

Thank you. It's an honor to be here.

Well, big year for you.

Yeah With data earlier in the year.

We'll talk about that as well. Maybe for folks who are not yet familiar with the story, just maybe give a broad overview of the company, the pipeline, and key priorities for the next 1-2 years.

Right. Avalo, AVTX, is a clinical-stage biotech company based outside of Philadelphia. We have been around in various iterations of the company before, but the important part of our history really begins with the recap of the company in 2024, and the initiation of our development of our lead asset abdakibart, which is a very high potency anti-IL-1 beta monoclonal antibody, which we have in the clinic right now, in phase II, heading into phase III for HS, moderate-to-severe HS. After we recapped the company in 2024, we got straight to work building the right team that we needed and initiating the phase IIb LOTUS trial, which was a definitive proof of concept study run at a very rigorous, and I would say, pivotal standard and analyzed the same way, which we enrolled in really very rapidly, and had our data readout this May.

That showed extremely. We were very pleased with the results, very positive results, very consistent results, which we can talk about in a little bit more detail, and giving us the impetus to move into phase III. We were then able to raise the capital we needed to be able to get us through the phase III program, which will conclude in 2029. We are able to expand our pipeline with AVTX-010, which is a longer PK version of AVTX-009, we have not disclosed all the details, and start to make preparations for expanding other indications. So that is where we are right now. We are in expansion mode, getting ready to meet with FDA for our end-of-Phase 2, phase III initiation program, get the CRO in place, and get our clinical trial supplies manufactured.

Great. Maybe going to the phase II data that you presented this year. You have had some time to discuss this data, probably with the KOLs as well. So what has been the physician feedback on the data, and what are some of the key highlights from that data set for you that surprised you to the upside?

Yeah, they are super excited by this. These are the best data that have been shown in a really rigorous, large phase II trial. Yes, you could see some results out there from smaller studies, but it is a little bit more difficult to interpret in a variable disease like HS. But they were very excited by the data.

In fact, what we heard over and over again is, "We weren't absolutely certain about the IL-1 beta hypothesis in HS before your data, but now that we see these data, we're absolutely convinced that this is a very robust and consistent treatment effect." That was shown by hitting in the low to mid-40s in terms of efficacy at HiSCR 75, but also in the consistency of the response across IHS4, HiSCR 50, HiSCR 90, all of the measures that we used, and all of the secondary parameters. The consistency was also temporal. The data were very clean, the curves were very smooth, and the effect looked very sustained. It was also a very robust effect equal to naive patients and biologically experienced patients, including patients who'd been on IL-17s. They were very excited about it, as were we.

I think we haven't shared our biomarker data yet. We're going to do that at a scientific meeting. But I can say, and many of them looked at that, too, that it was all the more convincing by how effectively we engaged the target, which was IL-1 beta, and all of the other secondary measures as well.

Got it. You highlighted the consistency of data across endpoints. That was kind of striking as well if you look at bio-naive versus refractory.

Yeah. This is in a placebo-controlled setting as well.

When you look at that, the HiSCR curves also looked a little bit different and better for abdakibart versus, let's say, even lutikizumab. I guess what's driving that differentiation mechanistically or between lutikizumab and your data set?