Mineralys Therapeutics, Inc. Common Stock Wells Fargo 21st Annual Healthcare Conference

Yeah, we are appreciative of the opportunity to join the Wells Fargo conference. Always a productive time for us. We are very excited about the opportunity that is in front of us. Lorundrostat has proven over the last five years to really be a meaningful introduction in the treatment of hypertension as well as some of the related comorbidities. Targeting aldosterone, which we think is a key node and will be for the, frankly, next decade or so in trying to address and alleviate the concerns around cardiorenal metabolic disorders. The data that we have generated went into the NDA that we filed late last year. I would say those dialogues continue to be productive with the agency targeting a PDUFA date of December 22 of this year.

I am sure we will get a chance to talk about it, but Eric and his team have done a really outstanding job ensuring we have a successful launch, building out the key vectors of market access, med affairs, marketing, and building out to a sales team. We are excited about the opportunity in front of us. We are excited about the opportunity of really making a meaningful difference in the lives of patients that are dealing with uncontrolled and resistant hypertension. We think lorundrostat stands to be a really transformative treatment for those patients.

Yeah. We've progressively, over the last two years, been, I think, appropriately building the functions that are necessary to ensure a successful launch of lorundrostat. Eric joined us in April of 2025, put his leadership in place for market access, marketing. We had had a medical affairs presence going back to 2024, really highlighting the importance of aldosterone, the role that plays in cardiorenal metabolic disorders, building advocacy. As we entered this year, we continued to add to the various key levers that are going to be important to ensure that successful launch. So in Q1, we put in place a national accounts team, getting in front of the payers, the PBMs, the insurers. We knew that AstraZeneca would be there as well with their anticipated PDUFA and eventual launch in June.

Making payers aware that there are going to be two ASIs, the value proposition of lorundrostat. In Q2, we augmented and expanded our medical science liaisons as a field-based medical staff to really continue to go deeper into the advocacy network and build an energy, enthusiasm, and appreciation for aldosterone as a target, ASIs as a treatment approach. The marketing team has been progressively preparing messaging the creative, the branding that goes behind that. As we've guided our intent is to have our sales force in place ahead of the PDUFA date, that would enable us on presumed successful approval, rapidly moving into launching it and lorundrostat in the hands of the patients. Behind that, we've continued to really focus on how do we prepare this organization for that transition. How do we continue to look at the development of lorundrostat?

We're not done with the clinical work. We're continuing to evaluate where do we want to go next with this transformative agent. But always with a mind to being lean, being efficient, and really focused on value that we can generate with each person that we bring into the organization.

Yeah, I think it's a bit early to provide the specific metrics we're going to look at. We may do that down the road. I think the way we think about this market opportunity can be informative, and we're really looking to create accessible choice, if you will. Eric can talk more about that. But creating accessible choice is a key strategic vector for us. We've always talked about there's a really targeted population that are treating probably 40%-50% of all of these third line or later uncontrolled or resistant hypertension patients. About 50,000 doctors, plus or minus, can be a very efficient sales footprint. Eric's got great experiences, does his team, with then overlaying that with an omnichannel, tapping into the efficiencies of digital.

All of that will speak to the strategy that we're doing, and from that, we'll determine what is going to be ideal to help inform investors on the launch of lorundrostat, but probably guiding to that later this year, maybe early next.

I think we're going to be able to have a layered approach with that. I think those 50,000 or so physicians we would have intent to address the vast majority with sales force, and then overlay that with omnichannel. That digital strategy enables us to go beyond the 50, but do it in a very efficient, high ROI way. That's part of what we would be looking to provide guidance on once we get to the appropriate stage to provide that.

Yeah. It's something that we've been thinking about really almost at the outset of Mineralys's formation. It informed how we did our proof of concept program. It informed how we did our pivotal program, and it was really looking at the dynamics from an access standpoint, a payer standpoint, and the biology of uncontrolled and resistant hypertension. That third-line or later is where our data really resides. We don't see a difference in response whether it started third-line or fourth-line. There's going to be utility from a treatment standpoint for both those 10 million patient populations. I think our view going into the marketplace is we'll make physicians aware of that utility, but I think the payer landscape will probably be more open at the fourth-line initially.