MBX Biosciences, Inc. Common Stock Morgan Stanley 24th Annual Global Healthcare Conference

Okay, great. Good morning, everyone. Welcome to day 3. We are saving the best for last here at the Morgan Stanley conference. I am Jason Russell, and it is a pleasure to welcome MBX to the stage. CEO Steve Hoerter, as well as Dr. Sam Azoulay, who is the Chief Medical Officer. MBX's first time here at the Morgan Stanley conference. We are pumped to have them with us. Just as a quick overlay for those that do not know, MBX is developing long-acting precision peptide therapeutics lead in the clinic, late stage, canvuparatide now, I think, officially started in phase III.

That is right. For chronic hypoparathyroidism, and very exciting, MBX 4291 potential true once-monthly GLP prodrug for obesity with, I think, some data expected later this year.

Steve, Sam, welcome. Thank you for being here.

Thank you. Yeah, thanks for the invitation.

Maybe we'll start with some high-level perspective. I mean, Steve, you took the CEO job recently, stepped in from the board, and I think in July, at a very important moment for the company. I already talked about where we are in the clinic. You have a very unique operating experience having transitioned Deciphera into a commercial stage company and a successful exit. So, maybe starting with your priorities as the CEO, what are the things that, if we step back 12 months from now, that you think investors should judge you and the team's performance on?

Yeah. It's been a really transformative year for the company in 2026. Just to set the stage, Jason, and by the way, thanks for the invitation to join for the conference. We'll talk about this, I'm sure, during the course of our time together this morning, but we reported earlier this year 12-month open label extension data from the phase II Avail study of canvuparatide in chronic HP, demonstrating sustained clinical benefit for this once-weekly injectable, this once-weekly PTH replacement therapy. As you referenced, we've now moved into a pivotal phase III study, having dosed the first patient just a matter of a couple of weeks ago. So we are well on our way now with the phase III and have clear line of sight to the potential to be a commercial company.

So we're starting to do all of the work that we need to do internally to prepare for eventual future commercialization in what is a market that is now clearly being validated as a multi-billion dollar peak revenue potential market, where there's a daily injectable that's on the market, which has reported now a billion-dollar run rate in revenue. We believe that our once-weekly canvuparatide has the potential to be best in class and to take the lion's share of that market. So if we think about the canvuparatide part of the business, it's a really exciting point in time and moment as we cast our vision to the future to be a commercial stage company with canvuparatide.

Then at the same time this summer, in fact, earlier in the summer, we gave a sneak peek at some blinded data from an ongoing phase I study of MBX 4291, and this is a true once-monthly GLP-1/GIP co-agonist that we're exploring, obviously, for the treatment of obesity. The early data was very encouraging. We showed PK data that demonstrates true once-monthly dosing. We showed early weight-lowering data, which was encouraging, and in addition, we showed that our prodrug technology, which delivers not only an infusion like PK, but allows us to control the release of active peptide to a slow and steady rise to Cmax. We showed that there's the potential for that technology as it relates to the co-agonist to deliver improved tolerability.

So as I think about priorities and what is to come in the next 12 to 18 months, it is really about canvuparatide getting to full enrollment in that pivotal study, which we expect in the second half of next year, and then doing all of the work we need to do to prepare for eventual future commercialization. As it relates to MBX 4291, it is about our Q4 disclosure, which will be from part C of the study, cohort C1, where we will have unblinded data for the first time with a goal being to deliver on this TPP of competitive weight loss, improved tolerability, and true once-monthly administration.

I think if we are able to achieve that, this has the potential to be a fundamental frame shift in the obesity landscape because I think the field knows that less frequent administration is preferred by patients, and certainly, our ability or the potential to have a better tolerability profile with a co-agonist, I think is highly attractive to patients.

That is great. We are going to peel the onion back on all of that. Incredibly exciting time to be joining the company in an operating capacity. Let us step back and just talk about the foundational capabilities for a minute. When the company went public a number of years ago, obesity was kind of out there as a dream at that point. Now it is very much in front of us, but it all comes back to this kind of foundational capability on PEPs or precision endocrine peptides. Maybe just give us a little bit of perspective around what the unique capabilities are for MBX, maybe some history around how that came together.

Mm-hmm. Sure. The company was founded in 2018 by Richard DiMarchi, our scientific co-founder, and by Kent Hawryluk. Richard is a thought leader in the field of peptide chemistry. He is at Indiana University currently, but spent 20 years of his post-academic career at Eli Lilly and Company, and then subsequent to that, spent time at Novo Nordisk. His insights into, and the work that he has done over the years, he is a co-inventor, I think on about 100 patents. Has published over 300 times in the peer-reviewed literature. His work at Lilly, for example, was instrumental in the first rapid-acting insulin at Lilly, FORTEO, other innovations. His work on peptides generally has really formed the foundation for the now multi-agonist approach with peptides like Lilly's tirzepatide. He has been really sort of the father of the field, if you will.

His work and his founding at MBX, scientifically, really centered on three pillars as it relates to peptides. One was being able to design peptides with improved pharmaceutical properties. The second related to the ability to utilize a fatty acylation, of course, for extended time action. The third, and probably most important, is the prodrug technology. This allows us to deliver a very simplistic prodrug in a way to patients that then regulates the release of active peptide. As you think back to whether it is canvuparatide in the case of HP or very importantly, MBX 4291, the co-agonist for obesity, we are able to engineer a rate of release for the active peptide that then delivers, we believe, a differentiated PD profile.

That is what is so exciting about the PEP platform and the work that Richard DiMarchi has done that is really instrumental and ingrained in all of the clinical programs that we have.