Mineralys outlines NDA submission timeline and advances lorundrostat trials amid expanded clinical focus

Earnings Call Insights: Mineralys Therapeutics (MLYS) Q3 2025

MANAGEMENT VIEW

* Jon Congleton, President and CEO, shared that Mineralys received pre-NDA feedback from the FDA with "no surprises" and is moving ahead with its NDA filing for lorundrostat, expected "either late this quarter or in the first quarter of 2026." He highlighted, "we developed a robust data package featuring results from multiple clinical trials... which we believe support its potential as a best-in-class treatment for high-risk patients with uncontrolled or resistant hypertension and beyond."
* Congleton emphasized the pivotal Launch-HTN and Advance-HTN trials, stating the results "demonstrate that lorundrostat offers a clinically meaningful and sustained reduction in systolic blood pressure," and outlined subgroup analyses confirming consistent efficacy across diverse and difficult-to-treat populations.
* The CEO discussed recent data from the Explore-CKD trial, noting that lorundrostat showed a "clinically meaningful reduction on systolic BP in 4 weeks and was well tolerated," and that a key secondary outcome, reduction in urinary albumin creatinine ratio, was "clinically meaningful and highly statistically significant."
* For the ongoing Phase II Explore-OSA trial, Congleton said enrollment was complete and "we anticipate reporting top line results from the trial in the first quarter of 2026."
* Adam Levy, CFO, stated, "We ended the quarter with cash, cash equivalents and investments of $593.6 million as of September 30, 2025, compared to $198.2 million as of December 31, 2024. We believe that our current cash, cash equivalents and investments will be sufficient to fund our planned clinical trials and regulatory activities as well as support corporate operations into 2028."

OUTLOOK

* Congleton reiterated that the NDA for lorundrostat is targeted for submission "either late this quarter or in the first quarter of 2026." He also expressed confidence in the strength of the clinical data and the company's commercial readiness, stating, "we are prioritizing market access planning and payer engagement to ensure the value of lorundrostat is well understood."
* Management maintained that ongoing trials, including Explore-OSA, are integral to broadening lorundrostat's clinical profile and commercial potential in comorbid conditions.

FINANCIAL RESULTS

* Mineralys reported R&D expenses for Q3 2025 of $31.5 million, down from $54 million in Q3 2024, primarily due to the conclusion of the lorundrostat pivotal program, partially offset by increased compensation and clinical supply costs.
* G&A expenses were $9.7 million for Q3 2025, compared to $6.1 million for Q3 2024, mainly due to higher compensation and professional fees.
* Total other income net was $4.2 million for Q3 2025, versus $3.8 million for Q3 2024, attributable to increased interest earned on investments.
* The company reported a net loss of $36.9 million for Q3 2025, compared to $56.3 million for Q3 2024.

Q&A

* Umer Raffat, Evercore: Asked about the impact of not adjusting for discontinuations in the resistant hypertension cohort. Congleton responded that analysis was not performed and emphasized the importance of accounting for all subjects, while David Rodman, Chief Medical Officer, explained "we did exactly what we negotiated with the FDA should be done in the situation of missing data."
* Jin Law, Goldman Sachs: Inquired about day vs. night efficacy data from Advance-HTN. Congleton replied, "we have always measured blood pressure in the morning before that day's dose... we're very comfortable with daytime and nighttime blood pressure reduction," but noted nighttime data has yet to be published.
* Alice Nettleton, BofA Securities: Asked for more color on pre-NDA feedback and partnering updates. Congleton stated, "we haven't really disclosed that, but we're comfortable with the feedback" and reiterated confidence in the data set. On partnering, he noted, "partnering is going to be a key component... that is for ex U.S. commercialization opportunity, maximization of value, but also in the United States."
* Jayed Momin, Stifel: Sought updates on the open-label extension trial and use of Explore-OSA data. Congleton reported "no surprises" in the open-label extension, with continued confidence in safety, and said Explore-OSA aims to demonstrate benefits beyond blood pressure reduction.
* Mohit Bansal, Wells Fargo: Asked about differences between lorundrostat and competing ASIs, as well as partnership strategy. Congleton stated, "we feel very comfortable with our best-in-class profile at this point" and that partnership remains a critical focus.
* Rami Katkhuda, LifeSci Capital: Inquired about trial demographics and efficacy in African-American patients. Congleton highlighted intentional diverse enrollment and consistent efficacy across races, sharing, "44% in Launch got to goal at week 6, and... 42% got to goal at week 4 with Advance," with placebo groups about half that rate.

SENTIMENT ANALYSIS

* Analysts focused on trial design, missing data handling, competitive positioning, and partnership prospects, expressing a mix of curiosity and cautious optimism.
* Management maintained a confident tone, emphasizing "no surprises" from FDA engagement, strong clinical data, and financial runway. Congleton repeatedly used phrases like "we are more confident than ever" and "we feel very comfortable," underscoring high confidence in lorundrostat’s profile.
* Compared to the previous quarter, the sentiment was consistent, with analysts probing for competitive differentiation and regulatory clarity, while management remained assertive about lorundrostat’s strengths.

QUARTER-OVER-QUARTER COMPARISON

* The current quarter provided a clearer NDA timeline, with the filing anticipated "either late this quarter or in the first quarter of 2026," compared to last quarter’s focus on the upcoming pre-NDA meeting.
* There was increased emphasis on clinical trial diversity and subgroup efficacy analyses, particularly in African-American and high-risk populations.
* Management tone remained confident, with a continued focus on partnership strategies and commercial readiness. Financially, R&D expenses decreased from the prior quarter as pivotal programs concluded, and the cash position improved substantially.
* Analysts’ questions continued to center on competitive comparisons, data robustness, and regulatory progress, mirroring the previous quarter.

RISKS AND CONCERNS

* Management acknowledged the challenge of addressing missing data in trials, emphasizing adherence to FDA-negotiated statistical plans.
* Analysts expressed interest in competitive dynamics with other ASIs, especially regarding trial design and patient population differences.
* No new significant business risks were disclosed beyond the ongoing need for regulatory approval and successful commercialization.

FINAL TAKEAWAY

Mineralys Therapeutics remains focused on advancing lorundrostat toward regulatory approval, highlighting robust clinical data, broad patient efficacy—including in diverse and hard-to-treat populations—and a strong financial position projected to fund operations into 2028. The company anticipates filing its NDA by early 2026 and is preparing for commercial launch, with expanded development in comorbid conditions and active pursuit of strategic partnerships both in the U.S. and internationally. Management’s tone throughout the call reflected high confidence in lorundrostat’s clinical and commercial prospects as it approaches key regulatory and clinical milestones.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/mlys/earnings/transcripts]

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