Kailera Therapeutics Stifel 2026 Virtual Cardiometabolic Forum
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Hi. Good morning, everyone, and it's our pleasure to have Kailera with us today, who is somewhat new to the public markets. We have with us CEO Ron Renaud, an industry veteran, CFO Doug Pagán, and then CMO Scott Wasserman. Kailera has a very full pipeline of obesity products with dual agonist and injectable and oral form single agonist, soon triple agonist. Maybe first you can give us an overview of your pipeline and tell us in a crowded development landscape, what Kailera brings to the table in terms of differentiating features.
Yeah. Good morning, Annabel. Good morning.
Sure. Thank you. Thanks for having us. As Annabel said, I'm Ron Renaud. I'm the President and CEO here at Kailera. Look, we were put in place, we were built with one goal, and that's to elevate the next era of obesity care. As you've written about, Annabel, and I think everybody on this call knows and understands, obesity is clearly one of the largest opportunities in medicine. My guess and my sense is it will be for the foreseeable future. I don't see that changing anytime soon. We know that current GLP-1 medications have changed patients' lives, but demand for all of these GLP-1 based therapies far, far outstrips supply. Most eligible patients are not treated, and patients and physicians want more choices, and I think that's where Kailera comes in.
They want stronger weight loss, they want better tolerability, they want oral options, and they want combinations. There are very few companies that can actually provide that kind of breadth in terms of an obesity-based pipeline. I think history tells us that big categories, we can go back in time, we can look at statins, we can look at immunology, we can look at immuno-oncology. The third, fourth, fifth entrant can win when it brings meaningfully better data, and Kailera intends to be that company in obesity. As you point out, we've got a robust multimodality pipeline. Scott can take you through the details of each of the programs, and Doug can clearly tell you how we're going to make sure that we leverage our great balance sheet to get all of this done. I'll just give a high level in terms of where we are.
Our lead program is rebupatide. We've got rebupatide injection. It's formerly known as KAI-9531. This is our lead. It's a once-weekly GLP-1/GIP dual agonist. This morning we announced that our KaiNETIC program is fully enrolled.
Nearly 5,000 patients across 200 sites in 11 countries. Really, really a global approach to developing this program. Behind that is the exact same molecule in a once-daily pill. That's our rebupatide oral program. Very, very excited about this. Scott can talk about the phase II data that generated some very, very compelling weight loss with some of the, I think, what is the best GI tolerability and AE side effect profile that we've seen in the business. Behind that is Safaglipron, formerly known as KAI-7535. That's our oral small molecule GLP-1 receptor agonist. Then, of course, we've got a once-weekly GLP-1/GIP glucagon triagonist. Really, that's KAI-4729. Really multiple approaches to treating obesity. Hopefully can meet any patient living with obesity anywhere where they are in their treatment path.
Couple other items I think that are really, really important to point out here is how we built this portfolio so quickly. Why is it so robust Yeah and how did it get so deep so quickly?
That is through our Hengrui relationship. This is a pipeline that was built on the basis of this relationship. It allows us to do a lot of things that other companies in the space can't do. First of all, we get human data before we commit capital. Each program that we enter basically has clinical data that is generated by our colleagues at Hengrui before we have to make a capital investment decision. Then they keep producing data that we don't pay to generate. From a capital allocation, from a cost efficiency perspective, this really, really helps us make well-educated decisions, that are risk adjusted and in terms of capital allocation, making sure our money is going in the right place.
Lastly, what I'll say here is we've got a team that's done this before. Doug has done this before, Scott has done this before, and we've got a deep bench. We've got Jamie Coleman, who leads our commercial efforts, and I don't think there's anybody in the business that knows more about the obesity marketplace than she does. Really a great team of people that have been there and done that. With that, we're happy to jump into questions.
Yeah. That's fantastic. Thanks for the overview. Going right into tirzepatide, that delivered 21% placebo-adjusted weight loss in the phase IIb, which clearly exceeds tirzepatide. What factors do you think contribute to that molecule being so potent? Is it the ratio? What is it exactly, and how is that balanced against tolerability? You mentioned you have some of the best tolerability, so talk to us about that potency versus tolerability and how you got there.
I'll let Scott take you through that. He knows it inside and out.
Yeah. Thanks, Ron, and thanks, Annabel, and good morning to everybody. Just very, very quickly, when Hengrui designed rebupatide or KAI-9531, they designed it to be better than tirzepatide. And what we mean by that is they purposefully engineered the molecule to have 3X potency on the GLP-1 receptor, 0.5 on the GIP versus tirzepatide, and a 7-day half-life, which is 2 days longer than tirzepatide. In and of itself, how they designed molecule was to be better than tirzepatide. At least preclinically, that played out as they were developing it, and that's how they ended up choosing to move it forward. At least clinically to date, based on the data that they've generated, we have a very compelling profile.
Obviously, as Ron just alluded to, we just announced this morning that we completed the enrollment of KAINETIC, our phase III program, 3 different studies. We're really looking forward to having that data in the mid-2028 timeframe.
That's great. Maybe you can talk about that phase III KAINETIC program. It's designed not just for obesity but type 2 diabetes, and you have an interesting component of greater than 35 BMI. Why the segmentation in that direction for that very obese population? What discussions have you had with FDA on how you're setting yourself apart there, and what is the actual efficacy bar there? Maybe you can address those questions.
Yeah. I'm more than happy to take those questions.
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