Mineralys Therapeutics, Inc. Common Stock Stifel 2026 Virtual Cardiometabolic Forum
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Hi. Good morning, everyone. Actually, good afternoon, and welcome to the Mineralys session. It's our pleasure to have with us CEO Jon Congleton and CFO Adam Levy with us today. We're talking about the hypertension landscape that saw its first new class in aldosterone synthase inhibitors just this year. I think the market has started to turn towards these ASIs. Mineralys is obviously awaiting their PDUFA for the second to market, and presumably, hopefully more broadly applicable in lorundrostat than the first. Maybe you can give us a quick overview, Jon, and then we can launch into Q&A. Is Jon frozen? He's coming back.
There we go. Apologies, Annabel.
I don't know. You're leaving us in suspense.
Apologies. It was right as you were giving the nice introduction. All of a sudden, everything just went gone.
It's all right. Yeah. We're human.
We're not AI. I didn't touch anything, I promise.
Maybe you can give us a quick overview, and then we can launch into some Q&A.
Yeah, happy to do it, and apologies about that.
No worries. And really appreciate Stifel hosting this, Annabel, the invite and the chance to speak.
Look, we're really excited about everything that's coming forward for the company. We've spent the last five years really thoughtfully developing lorundrostat. And what I mean by that is it's been 20 years since there's been any innovation in this space, so we're really developing a data set for those patients third line and later that could benefit from lorundrostat. Build a data set that informs not only physicians, but payers, speaks to the unique needs of these patients and their efforts to try to get to goal. We were excited about the NDA late last year. I would say the dialogue with the FDA headed into our PDUFA December 22nd this year has been normal course, so very excited about that. Our commercial pre-launch plans are very much on track.
We've got a very experienced commercial leadership team. We continue to have really good dialogues with thought leaders in this space, the payers that cover the vast majority of patients' lives in the U.S., and are really doing everything you would expect a big pharma to basically be doing in preparation for launch. Our goal is on track for having our sales team in place by the time of the PDUFA date. So just very excited with the progress there. From a capital standpoint, we reported at the end of Q2, we have $661 million in capital available. We believe that's sufficient to get us through the launch and support the launch of lorundrostat. Just overall, it's exciting times.
We're getting close to the point of achieving what we really set out to achieve, and that is to get this drug into the hands of patients and make a meaningful difference in their lives.
Great. Thanks for the intro. Maybe like I mentioned earlier, obviously the entry of the first ASI just happened with Baxfendy. How would you say now that there's one on the market that the medical community is receiving this novel class? Is it viewed as a welcome addition, or are they still trying to really understand its place and the population?
Yeah, I would say the early signal is very encouraging. We see the same data that you all see as far as the number of RXs, the number of patients. But I think most critically, it's very supportive of the market research we've been conducting for five years that- really articulates the unmet need.
Over half of the patients treated can't get to goal. Clearly there's a need for alternatives, new innovative solutions, particularly ones that target aldosterone. The demand that we saw in the market research, I think, is playing out in real time with baxdrostat. I think there were always questions about access over the last five years. Our market research clearly said these payers understand the clinical value of getting patients to goal, and that access would be available. I think this early days of the baxdrostat launch further support that access is going to be there for innovation. I think it's encouraging from our standpoint, but I wouldn't characterize it as surprising.
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