Mineralys Therapeutics Q1 Earnings Call Highlights

Key Points

• Mineralys’ NDA for lead candidate lorundrostat was accepted by the FDA with a PDUFA date of December 22, 2026, supported by a comprehensive dataset from LAUNCH‑HTN, ADVANCE‑HTN, TRANSFORM‑HTN and other studies showing clinically meaningful blood pressure reductions and tolerability.
• The company is preparing for a potential U.S. launch focused on fourth‑line resistant hypertension (patients uncontrolled on ≥3 meds), citing prescriber and payer receptivity and aiming to differentiate via absolute systolic reductions (e.g., ~19 mm in LAUNCH‑HTN) and diverse trial populations.
• Mineralys ended Q1 with $646.1 million in cash and investments and says resources should fund operations into 2028; Q1 results showed a net loss of $39.3 million, R&D expense down to $24.4 million, and G&A rising to $21.0 million.

Mineralys Therapeutics NASDAQ: MLYS highlighted progress toward a potential U.S. launch of its lead candidate lorundrostat and reviewed first-quarter financial results during its May 6 earnings call, following the FDA’s acceptance of the company’s new drug application (NDA).

NDA accepted for lorundrostat with December PDUFA date

Chief Executive Officer Jon Congleton said the NDA acceptance in the first quarter marked a “significant regulatory milestone” for lorundrostat and reflected what he described as a major team effort. The FDA accepted the NDA for lorundrostat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs and assigned a PDUFA target date of December 22, 2026.

Congleton said the NDA is supported by a “comprehensive clinical data package,” including results from the LAUNCH-HTN and ADVANCE-HTN pivotal trials, TRANSFORM-HTN (the open-label extension), and proof-of-concept studies Target-HTN and Explore-CKD. He said the five trials collectively showed clinically meaningful blood pressure reductions, tolerability, and durability across diverse patient groups.

Congleton emphasized the company’s view that the breadth of the package could support inclusion in prescribing guidelines and demonstrate economic value for the healthcare system. He also reiterated the company’s focus on uncontrolled and resistant hypertension, which he said impacts more than 20 million people in the U.S. and contributes to cardiorenal complications.

Commercial preparations focused on fourth-line resistant hypertension

Congleton said Mineralys is preparing lorundrostat for a potential U.S. launch while continuing to evaluate partnering opportunities and potential next steps in clinical development. He said the company plans to initially focus on patients with resistant hypertension—generally those uncontrolled on three or more medications—where aldosterone dysregulation can play an important role.

Management cited ongoing market research suggesting three themes:

• Prescribers prioritize magnitude and consistency of blood pressure reduction and have expressed willingness to prescribe lorundrostat in the fourth line, Congleton said.
• Payers recognize high risk among patients uncontrolled on three or more medications and have expressed willingness to cover lorundrostat, according to Congleton.
• Patients are seeking sustained reductions that are tolerable and easy to integrate into daily life and have been receptive to novel agents, he said.

Congleton said the company is working on early market access planning and payer engagement, expanding medical communications efforts, and building out its field-based medical science liaison (MSL) team. He added that Mineralys is also expanding sales and marketing capabilities ahead of the PDUFA date.

During the Q&A, Chief Commercial Officer Eric Warren described the company’s go-to-market approach as “all about sequencing,” calling fourth line the entry point while pointing to an opportunity to move toward third line over time, particularly among patients with comorbidities. Warren said parity access with competing aldosterone synthase inhibitors (ASIs) is a focus.

Management discusses differentiation and guideline strategy

Several analysts asked about positioning relative to a competing ASI, baxdrostat, and the potential for differentiation. Congleton said he expects “a level of uniformity” in labeling within the hypertension indication, but argued Mineralys’ clinical dataset differs from competitors’ datasets, repeatedly highlighting ADVANCE-HTN as a distinct study intended to address complicated “confirmed hypertension” patients that cardiologists see. He also pointed to Explore-CKD and the potential importance of proteinuria-related signals for nephrologists, while noting that what ultimately appears in labeling will be part of discussions with the FDA.

Warren said physician feedback has emphasized two factors: “the absolute systolic blood pressure reduction” and the diversity of trial populations. He specifically cited “that 19 mm” systolic reduction demonstrated in LAUNCH-HTN and highlighted representation of Black/African American patients, saying trial participation ranged from “between 28 and over 50%” depending on the study.

On guidelines, Congleton said Mineralys has been engaging with physicians involved in guideline committees and believes the company has assembled a dataset intended to answer key questions those committees may have. He referenced work with the Cleveland Clinic and investigators Steven Nissen and Luke Laffin on ADVANCE-HTN, saying the study was designed to address questions around whether hypertension is “apparent” or truly confirmed. He also said LAUNCH-HTN, Explore-CKD, and Explore-OSA add context for resistant hypertension complexity.

Partnering remains under evaluation; company declines specifics

Congleton said Mineralys continues to evaluate partnering opportunities and described the potential benefit of a partner that could add value and reach more patients. When asked directly about timing and the status of discussions, Congleton said the company is “routinely evaluating” opportunities but is not in a position to provide specifics on “the level of dialogues, the timing, the structure.” He reiterated that commercial readiness work is “an important part of those partnering dialogues.”

Asked about broader potential beyond hypertension, Congleton said aldosterone is likely to remain a key target “into the 2030s” for hypertension and related comorbidities. He added that blood pressure reduction is a “clear surrogate” for what could be expected regarding cardiovascular risk reduction, while stopping short of offering details on other indications that may be prioritized in partner discussions.

First-quarter financial results: cash runway into 2028

Chief Financial Officer Adam Levy reported that Mineralys ended the first quarter with $646.1 million in cash, cash equivalents, and investments as of March 31, 2026, compared with $656.6 million as of Dec. 31, 2025. Levy said the company believes its current resources will be sufficient to fund planned clinical trials and regulatory activities and support corporate operations “into 2028.”

Research and development expense was $24.4 million, down from $37.9 million in the year-ago period, primarily due to a $15.5 million reduction in preclinical and clinical costs following the conclusion of the lorundrostat pivotal program in the second quarter of 2025. Levy said the decline was partially offset by higher clinical supply, manufacturing and regulatory costs, and increased personnel expenses tied to headcount growth and compensation.

General and administrative expense increased to $21.0 million from $6.6 million, driven mainly by higher professional fees and increased personnel-related expenses, Levy said.

Other income, net rose to $6.0 million from $2.2 million due to higher interest earned on investments in money market funds and U.S. Treasuries. Net loss was $39.3 million, compared with $42.2 million in the first quarter of 2025.

In closing remarks, Congleton said the company remains encouraged by the NDA acceptance and is focused on pre-commercial readiness while continuing partnering evaluations and considering further clinical development steps for lorundrostat.

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.

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