Mineralys Therapeutics Q4 Earnings Call Highlights

13 Mar 2026, 00:46 by Michael Walen · The Markets Daily

Mineralys Therapeutics (NASDAQ:MLYS) used its fourth-quarter and full-year 2025 earnings call to highlight a key regulatory milestone for lorundrostat and to review new clinical and financial updates as it prepares for a potential commercial launch.

FDA accepts lorundrostat NDA; PDUFA date set for December 2026

Chief Executive Officer Jon Congleton said the company recently announced the U.S. Food and Drug Administration’s acceptance of its new drug application (NDA) for lorundrostat to treat adult patients with hypertension in combination with other antihypertensive drugs. The FDA assigned a PDUFA target action date of December 22, 2026.

Congleton said the NDA was supported by a clinical program that included “five positive clinical trials,” which he said consistently demonstrated clinically meaningful blood pressure reduction, 24-hour control, and a favorable safety profile. The NDA includes data from the company’s pivotal trials Launch-HTN and Advance-HTN, as well as the proof-of-concept Explore-CKD study and the open-label extension Transform-HTN. Congleton said the trials demonstrated durable response across diverse patient populations.

Company frames resistant and uncontrolled hypertension as large unmet need

Management emphasized the size of the market opportunity in uncontrolled and resistant hypertension. Congleton cited company statements that the condition affects “over 20 million people” in the U.S. and is attributed to nearly 700,000 deaths per year. He also reiterated the company’s view that roughly 30% of hypertension patients have dysregulated aldosterone, and said the company is seeing increasing research and guideline attention around identifying and addressing aldosterone dysregulation.

Congleton positioned lorundrostat—an aldosterone synthase inhibitor—as a differentiated option relative to “current third- and fourth-line treatment options,” particularly for patients whose hypertension is difficult to control.

Explore-OSA misses AHI endpoint but shows blood pressure reduction

Congleton also discussed top-line results from Explore-OSA, a four-week exploratory trial in participants with moderate to severe obstructive sleep apnea (OSA) and hypertension. The study enrolled 48 participants and, according to management, represented a high-risk population with an average body mass index of 38, an average apnea-hypopnea index (AHI) of 48, and baseline systolic blood pressure of 142 mmHg.

The company said lorundrostat did not show a clinically meaningful difference versus placebo on the primary endpoint (AHI). However, management highlighted blood pressure improvements and tolerability:

In a pre-planned parallel arm analysis of the first period, the company reported an 11.1 mmHg blood pressure reduction with lorundrostat and a 1.0 mmHg reduction with placebo at four weeks.
In a crossover analysis, the company reported a 6.2 mmHg placebo-adjusted reduction in blood pressure.
The company said lorundrostat was well-tolerated with no serum potassium excursions above 5.5 mmol/L.

Chief Medical Officer Dr. David Rodman said it was unclear whether the four-week duration was long enough to evaluate AHI effects and suggested demographics may have influenced the outcome, noting the population’s obesity and high AHI burden. He described a hypothesized mechanism involving fluid shifts when lying down that may be harder to impact in a population where structural airway obstruction from adipose tissue is severe.

Rodman also argued that reducing AHI is not necessarily the company’s primary objective in OSA, emphasizing the goal of improving long-term outcomes. He noted that the level of blood pressure reduction observed could be meaningful for cardiovascular risk, and said the company believes it can address these patients under an anticipated hypertension label because many OSA patients also have uncontrolled or resistant hypertension.

Rodman added the company is continuing deeper analyses of the Explore-OSA dataset, including subgroup assessments, but cautioned the study size makes such work hypothesis-generating. He said about a quarter to a third of subjects used CPAP, and the company did not observe differences between CPAP and non-CPAP groups, though numbers were small.

Launch preparations: payer engagement, medical affairs expansion, and commercialization planning

Congleton said the company has begun market access planning and payer engagement to communicate lorundrostat’s value proposition. He also said the company is expanding medical communications through additional peer-reviewed publications, a larger presence at scientific meetings, and a broader field-based medical science liaison (MSL) organization.

On payer discussions, Chief Commercial Officer Eric Warren said he had attended a “large payer conference” and that payers were aware of the program and aligned with the company’s initial positioning. He said the company was scheduling pre-approval information exchange (PIE) discussions and described interactions as favorable.

Management repeatedly described an initial “beachhead” in fourth-line treatment, with potential expansion toward third-line use over time as experience and demand grow. Congleton said payer research indicated the value proposition resonates with some payers in fourth line and, in some cases, third line. He also referenced prior commentary framing pricing at a “branded price point” comparable to SGLT2 inhibitors or Entresto at wholesale acquisition cost, while declining to provide specifics on rebates.

Asked about competitive dynamics, Congleton acknowledged awareness that AstraZeneca could launch a competing product earlier and said the company would watch items such as pricing and commercial footprint. Still, he said management believes the market is large enough for multiple novel therapies and expressed confidence in lorundrostat’s “best-in-class” profile.

Congleton also discussed commercial targeting, stating that about 60,000 physicians account for half of third-line-or-later prescriptions in the U.S., and said the mix is roughly 60% primary care and 40% specialty, with cardiologists comprising much of the specialist segment. He said the company is also evaluating subsegments tied to comorbidities such as chronic kidney disease and OSA.

Financial results: higher cash balance, lower R&D, higher G&A

Chief Financial Officer Adam Levy reviewed full-year 2025 results and said the company ended 2025 with $656.6 million in cash, cash equivalents, and investments, compared with $198.2 million at the end of 2024. Levy said the company expects its cash resources to support planned clinical trials, regulatory activities, and operations into 2028.

For the year ended December 31, 2025, Mineralys reported:

R&D expenses of $132.0 million, down from $168.6 million in 2024. Fourth-quarter R&D was $24.4 million, down from $44.6 million a year earlier.
G&A expenses of $38.6 million, up from $23.8 million in 2024. Fourth-quarter G&A was $13.9 million, up from $7.2 million a year earlier.
Other income, net of $16.0 million, up from $14.6 million, driven primarily by interest income on higher average cash balances.
Net loss of $154.7 million, compared with a net loss of $177.8 million in 2024. Fourth-quarter net loss was $32.2 million, compared with $48.9 million a year earlier.

Levy attributed the year-over-year decline in R&D largely to a $49.3 million reduction in preclinical and clinical costs tied to the conclusion of the lorundrostat pivotal program in the second quarter of 2025, partially offset by higher compensation, stock-based compensation, and increased clinical supply, manufacturing, and regulatory costs. The increase in G&A was driven primarily by higher compensation, higher professional fees, and other administrative costs.

Looking ahead, Levy said the company does not intend to provide R&D guidance, but he expects less R&D activity in 2026 than in 2025 given the wind-down of several trials, while noting the open-label extension remains ongoing and additional work could be initiated.

On potential partnerships and ex-U.S. strategy, Congleton said the company is evaluating options and suggested partnering could play a role outside the U.S., including potential co-development. He also cited external complexities such as “MFN and tariffs” as factors the company is monitoring as it considers how to approach markets beyond the U.S.

About Mineralys Therapeutics (NASDAQ:MLYS)

Mineralys Therapeutics, Inc, a clinical-stage biopharmaceutical company that develops therapies for the treatment of hypertension and chronic kidney diseases. It clinical-stage product candidate is lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor for the treatment of cardiorenal conditions affected by abnormally elevated aldosterone. The company was formerly known as Catalys SC1, Inc and changed its name to Mineralys Therapeutics, Inc in May 2020. The company was incorporated in 2019 and is headquartered in Radnor, Pennsylvania.