Mineralis (MLYS) Q3 2025: $395M Cash Surge Extends Runway Into 2028 as NDA Nears

November 10, 2025 | By EarningsIQ Research

Mineralis’ clinical execution and $395 million cash build position lorundrastat for a pivotal NDA filing, with data targeting unmet need in resistant hypertension and comorbidities. Focused trial design, diverse enrollment, and early payer engagement set the stage for a differentiated launch. Investors now look to NDA timing and Explore OSA results as next catalysts.

Summary

• Pipeline Readiness: Lorundrastat’s NDA submission on track, leveraging robust efficacy and safety data across diverse populations.
• Financial Strength: Cash reserves extended through 2028, supporting full clinical, regulatory, and launch activities.
• Commercialization Focus: Market access, payer engagement, and partnering are now front and center as launch preparation accelerates.

Performance Analysis

Mineralis’ Q3 featured a sharp financial pivot, with cash, cash equivalents, and investments swelling to $593.6 million, up from $198.2 million at year-end. This capital influx, likely from a recent raise or milestone, gives the company a self-sustaining runway into 2028, a rare position for a pre-commercial biotech. R&D expense dropped to $31.5 million, reflecting the wind-down of pivotal lorundrastat trials, while G&A rose to $9.7 million as the company gears up for launch and regulatory activities. Net loss narrowed substantially to $36.9 million, underscoring disciplined cost management as the pipeline transitions from late-stage development to NDA submission.

Operationally, Mineralis completed pivotal programs and advanced multiple proof-of-concept trials. The focus has shifted from heavy trial execution to data analysis, regulatory engagement, and commercial planning. The EXPLORE-CKD trial delivered positive data in chronic kidney disease (CKD) patients with hypertension, while the EXPLORE-OSA trial reached full enrollment, with results expected in Q1 2026. These programs broaden lorundrastat’s addressable market and reinforce its positioning as a differentiated aldosterone synthase inhibitor (ASI) for high-risk, hard-to-treat patients.

• Cash Position Transformation: The $395 million increase supports full regulatory and commercial readiness, reducing dependency on near-term capital markets.
• Expense Realignment: R&D costs fell as pivotal trials concluded, while G&A rose in anticipation of launch and NDA activities.
• Clinical Breadth: Multiple studies, including in CKD and OSA, aim to expand lorundrastat’s profile beyond hypertension alone.

Mineralis is now at a critical inflection point, transitioning from a clinical-stage biotech to a late-stage, near-commercial company with the resources and data needed to support a best-in-class launch—if regulatory and commercial hurdles are cleared.

Executive Commentary

Strategic Positioning

1. Lorundrastat: Aiming for Best-in-Class Status in Hypertension

Lorundrastat, an aldosterone synthase inhibitor (ASI), is positioned as a potential best-in-class therapy for uncontrolled and resistant hypertension. The pivotal LAUNCH-HTN and ADVANCE-HTN trials demonstrated consistent, statistically significant reductions in systolic blood pressure across diverse, high-risk populations—including nearly one-third Black or African American participants and a majority with resistant hypertension. This diversity is unusually strong for the indication and supports broad label and payer acceptance.

2. Expansion Into Comorbid Indications

Mineralis is actively pursuing label expansion with trials in hypertension patients with chronic kidney disease (CKD) and obstructive sleep apnea (OSA). The EXPLORE-CKD trial not only showed blood pressure reduction but also a highly significant drop in urinary albumin creatinine ratio (UACR), a surrogate for renal protection. The EXPLORE-OSA trial, fully enrolled, will report in Q1 2026 and could further differentiate lorundrastat by targeting a high-risk, often undertreated segment.

3. Market Access and Payer Engagement

With pivotal data in hand, Mineralis is prioritizing market access planning and payer engagement, aiming to ensure favorable reimbursement and rapid uptake. Early surveys indicate strong interest among prescribers, especially for CKD patients, with 77% of clinicians expressing willingness to prescribe lorundrastat if approved. The company has also expanded medical communications and field-based teams to support launch readiness.

4. Partnering and Global Strategy

Management signaled that partnering is a core element of the commercialization plan, both for ex-US markets and potentially for US launch. With a well-characterized molecule and a de-risked clinical profile, Mineralis is positioned to drive value through co-development or commercial partnerships, maximizing reach and accelerating market penetration.

Key Considerations

Mineralis enters a pivotal period with its lead asset, balancing regulatory, commercial, and operational execution. The company’s ability to capitalize on its cash runway, diverse clinical data, and market access groundwork will define its transition to a commercial-stage biotech.

Key Considerations:

• NDA Timing and Regulatory Clarity: Submission is expected by Q4 2025 or Q1 2026, with FDA feedback so far in line with expectations.
• Population Diversity as a Differentiator: High enrollment of Black/African American and resistant hypertension patients sets lorundrastat apart from competitors’ datasets.
• Label Expansion Potential: Positive CKD data and imminent OSA results could broaden addressable market and payer value proposition.
• Commercialization Infrastructure: G&A growth and expanded medical affairs signal readiness for launch, but execution risk remains high in the first commercial cycle.
• Partnering Optionality: Ongoing dialogues could bring non-dilutive capital or accelerate international expansion, but terms and timing are uncertain.

Risks

Mineralis faces multiple risks typical of late-stage biotech: regulatory approval is not guaranteed, especially for first-in-class mechanisms in complex populations. Commercial uptake depends on payer coverage, prescriber education, and differentiation from both generics and branded competitors. Any delay in NDA submission, negative OSA trial results, or safety signals in long-term extension studies could materially impact the launch trajectory and valuation.

Forward Outlook

For Q4 2025 and early 2026, Mineralis guided to:

• NDA submission for lorundrastat by end of Q4 2025 or Q1 2026
• Top-line results from the EXPLORE-OSA trial expected in Q1 2026

For full-year 2026, management expects:

• Sufficient cash to fund operations, regulatory, and launch activities through 2028

Management highlighted several drivers for the next phase:

• Regulatory clarity and FDA engagement remain critical as NDA review progresses
• Partnering, both US and ex-US, is actively being pursued to maximize commercial value

Takeaways

Mineralis is strategically positioned with a late-stage asset, robust cash, and a differentiated clinical profile targeting a large, underserved patient population. The company’s operational pivot to commercialization, focus on payer engagement, and ongoing partnering discussions create multiple potential catalysts in the next 12 months.

• Cash-Backed Execution: The $395 million cash increase secures the company’s ability to execute on all planned activities without immediate dilution risk.
• Clinical Breadth and Diversity: Lorundrastat’s efficacy in diverse, high-risk populations and comorbid conditions is a core differentiator.
• Next Catalysts: Investors should watch for NDA submission, OSA trial results, and any partnering announcements as key value inflection points.

Conclusion

Mineralis’ Q3 marks a decisive transition from clinical execution to regulatory and commercial readiness, with lorundrastat’s broad data and cash runway underpinning confidence in its launch prospects. The next quarters will test the company’s ability to convert clinical promise into commercial reality.

Industry Read-Through

Mineralis’ focus on trial diversity, comorbidity expansion, and early payer engagement offers a blueprint for late-stage biotechs in cardiovascular and renal therapeutics. The robust enrollment of high-risk and minority populations sets a new standard for hypertension trials, likely increasing regulatory and payer expectations across the sector. The strong cash position and disciplined expense management highlight the value of pre-commercial capital raises, especially as launch costs escalate. Competitors in the ASI and resistant hypertension space will need to match both clinical breadth and operational readiness to secure share in this evolving market.

MLYS Healthcare Biotechnology Drug Development Hypertension Clinical Trials Commercialization