Mineralys signals pre-NDA meeting for lorundrostat in Q4 2025 while expanding clinical programs into cardiorenal comorbidities

Earnings Call Insights: Mineralys Therapeutics (MLYS) Q2 2025

MANAGEMENT VIEW

* CEO Jon Congleton highlighted Mineralys' leadership in developing aldosterone synthase inhibitors (ASIs) for hypertension and comorbid conditions, with pivotal data from Launch-HTN and Advance-HTN presented at major conferences and published in top medical journals. Congleton reported, "Clinically meaningful and sustained reductions in systolic blood pressure demonstrated with [Technical Difficulty] underscoring the unmet need, the desire for innovation in the management of hypertension and the commercial potential of lorundrostat."
* A survey of approximately 300 cardiologists and primary care physicians indicated that 95% would likely prescribe lorundrostat broadly for patients with uncontrolled or resistant hypertension if approved, driven by its differentiated efficacy and safety profile.
* The company completed a project with IQVIA showing nearly 9 million third-line or later hypertension patients started new treatments in 2024, supporting the significant market opportunity.
* Expansion of the medical communications team was reported to support prelaunch readiness, with efforts focused on market access and payer value assessment for lorundrostat.
* Congleton outlined the rationale for ongoing clinical programs, including the Explore-CKD trial for chronic kidney disease and the EXPLORE-OSA trial for obstructive sleep apnea, emphasizing clinically meaningful reductions in both systolic blood pressure and UACR.
* The company scheduled a pre-NDA meeting with the FDA for lorundrostat in the fourth quarter of 2025, with the intention of advancing regulatory approval.
* CFO Adam Scott Levy stated, "We ended the quarter with cash, cash equivalents and investments of $324.9 million as of June 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 2027."

OUTLOOK

* Management anticipates top line data from the EXPLORE-OSA trial in the near future and continues to focus on pre-NDA preparations for lorundrostat, with a scheduled meeting with the FDA in Q4 2025. Congleton reiterated that the company is "confident in the package that we put together and the comprehensive nature of it" for regulatory review.
* No explicit changes to guidance or forward-looking financial targets were provided compared to the previous quarter.

FINANCIAL RESULTS

* Levy reported R&D expenses of $38.3 million for Q2 2025, down from $39.3 million in the prior year period, attributed to the conclusion of the lorundrostat pivotal program, partially offset by increased compensation and clinical supply costs.
* G&A expenses totaled $8.5 million, up from $5.9 million the previous year, mainly due to higher compensation and professional fees.
* Other income net was $3.5 million, compared to $4.2 million the prior year, primarily due to decreased interest earned on investments.
* The net loss for the quarter was $43.3 million, compared to $41 million for the same period in 2024.

Q&A

* Michael DiFiore (Evercore): Asked about the impact of AstraZeneca's Phase III BAX-HTM data on lorundrostat's perceived safety and partnership plans. Congleton responded that it is difficult to speculate on competitor data but expressed confidence in lorundrostat's efficacy and safety profile, citing an ACE inhibitor/ARB hyperkalemia rate of 0.6% in Launch-HTN. On partnerships, Congleton confirmed ongoing interest, especially ex-U.S., and in the U.S. to maximize reach.
* Richard J. Law (Goldman Sachs): Inquired about combination opportunities for lorundrostat outside of SGLT2 inhibitors and potential impact of competitor data on partnership discussions. Congleton indicated the strong clinical performance of lorundrostat supports potential in multiple comorbidities and acknowledged room for multiple ASIs in the market.
* Seamus Fernandez (Guggenheim): Questioned drug-drug interactions, specifically with PPIs, and lorundrostat's 24-hour efficacy profile. Congleton clarified that PPI use was permitted in trials and that lorundrostat demonstrated robust 24-hour blood pressure control based on trial data.
* Alice Jennifer Nettleton (BofA): Asked about payer step edits and partnership hesitations. Chief Commercial Officer Eric Warren stated, "We do not anticipate a step through spironolactone... Instead, what's likely to happen is the payers will step us through 2 generic classes... which is easily navigatable through the cloud."
* Jayed Momin (Stifel): Sought details on commercial launch strategy and pre-NDA meeting preparations. Congleton said it is too early to detail commercial strategy but emphasized focus on payer strategy and dissemination of clinical data. He expressed confidence in the NDA package's comprehensive nature.
* Additional questions centered on trial design differences with AstraZeneca's BAX-HTN, open-label extension data plans, factors influencing FDA scrutiny, and R&D synergy for ASIs, with management emphasizing lorundrostat's broad potential and robust safety/efficacy data.

SENTIMENT ANALYSIS

* Analyst sentiment was generally inquisitive but cautious, with repeated questions about differentiation from competitors, safety (especially hyperkalemia), and commercial strategy. There was a slight edge of skepticism regarding market access and competitive dynamics.
* Management maintained a confident tone in both prepared remarks and Q&A, frequently referencing robust clinical data and physician survey support. Confidence was underscored by phrases like "we feel very confident" and "we remain confident in the value of lorundrostat."
* Compared to the previous quarter, analyst tone has shifted to a more competitive and risk-oriented focus, while management confidence and messaging have remained steady, with an increased emphasis on differentiation and pre-NDA readiness.

QUARTER-OVER-QUARTER COMPARISON

* The current quarter advanced from pivotal data announcements to pre-NDA regulatory preparations, with new emphasis on physician intent to prescribe and payer strategies. The previous quarter focused more on publishing pivotal trial results, key appointments (notably the Chief Commercial Officer), and ongoing clinical trial enrollment.
* Management's tone remained confident and forward-looking in both quarters, but the current quarter placed greater focus on commercial readiness and regulatory milestones.
* Analyst questions have become more focused on competitive threats, partnerships, and regulatory hurdles, versus earlier questions on trial mechanics and clinical endpoints.
* Key financial metrics show a slight increase in net loss and G&A expenses, with a decrease in R&D spend following pivotal trial completions. Cash position remains strong, supporting operational runway into 2027.

RISKS AND CONCERNS

* Management acknowledged the challenge of competitor data (AstraZeneca's BAX-HTN) potentially impacting physician perceptions and partnerships but emphasized lorundrostat's robust efficacy and safety data.
* Analysts raised concerns about hyperkalemia rates, payer access barriers (such as step edits), and regulatory scrutiny, particularly regarding potassium safety.
* Management addressed mitigation strategies, including physician education, payer engagement, and comprehensive data submission to the FDA.

FINAL TAKEAWAY

Management emphasized the clinically meaningful benefit-risk profile of lorundrostat for patients with uncontrolled or resistant hypertension and related comorbidities. The company is preparing for a pre-NDA meeting with the FDA in Q4 2025, supported by robust clinical data, strong physician interest, and a solid financial position to fund operations into 2027. The focus remains on regulatory advancement, commercial readiness, and differentiation amid emerging competition, with key milestones anticipated in upcoming quarters.

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

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