Mineralys Therapeutics (Nasdaq: MLYS) is a clinical-stage biopharmaceutical company dedicated to developing targeted therapies for cardio-renal-metabolic conditions driven by dysregulated aldosterone, a hormonal imbalance linked to hypertension, chronic kidney disease, and obstructive sleep apnea. Founded in 2019 and headquartered in Radnor, Pennsylvania, Mineralys employs about 51 people as of 2024.
$177.8M
Net Loss
Compared with $71.9 million in 2023, reflecting increased R&D spending to advance its pivotal hypertension and CKD trials.
$198.2M
Cash & Investments
Held by the company as of December 31, 2024, which expanded to $324.9 million by mid-2025, extending its financial runway into 2027.
Meaningful upside potential
Seen by analysts
Tied to multiple upcoming Phase II and Phase III readouts.
Financial Overview
Mineralys reported a net loss of $177.8 million in 2024, compared with $71.9 million in 2023, reflecting increased R&D spending to advance its pivotal hypertension and CKD trials.
The company held $198.2 million in cash and investments as of December 31, 2024, which expanded to $324.9 million by mid-2025, extending its financial runway into 2027. Analysts see meaningful upside potential tied to multiple upcoming Phase II and Phase III readouts.
Financial Table: Key Metrics
|
Metric |
2023 (Full Year) |
2024 (Full Year) |
Commentary |
|
Net Income/Loss |
−$71.9M |
−$177.8M |
Net losses reflect rising R&D investment as programs advance into Phase II and III trials. |
|
EPS |
−$3.25 |
−$5.68 |
Loss per share widened in 2024 due to higher operating expenses tied to pivotal programs. |
|
Cash & Equivalents |
$274.1M (Dec 31) |
$198.2M (Dec 31) |
Cash dipped in 2024 due to higher R&D spend, but rebounded mid‑2025 through financing, extending runway into 2027. |
|
Total Assets |
$280.5M |
$213.4M |
Assets primarily driven by cash holdings to support pipeline execution. |
|
Net Cash Used (Ops) |
−$71.2M |
−$168.9M |
Operating cash use expanded in 2024, consistent with late‑stage clinical activity. |
|
Operating Expenses |
$74.5M |
$192.4M |
Expenses grew significantly in 2024, dominated by R&D ($168.6M) as trials advanced; G&A remained modest. |
|
Cash & Equivalents |
$274.1M (Dec 31) |
$198.2M (Dec 31) |
Cash reserves declined in 2024 due to higher trial costs, though sufficient to fund near‑term programs. |
|
R&D Expenses |
$58.3M |
$168.6M |
Research spend nearly tripled year‑over‑year as lorundrostat programs moved into later‑stage studies. |
|
G&A Expenses |
$16.2M |
$23.8M |
Administrative expenses increased modestly, consistent with corporate growth but still low relative to R&D. |
Stock Performance
- Current Price (as of September 10): $37.16
- 52-Week High/Low: $39.20 / $8.24
- Market Cap: $2.89B
- Recent Movements: Up ~182% over the past month.
Intellectual Property
Mineralys has built a robust intellectual property portfolio, comprising 14 distinct patent families designed to protect its lead candidate, lorundrostat, and related technologies across key markets, with patent lifespans extending into the 2040s.
Pipeline Overview
Led by lorundrostat (MLS-101), Mineralys’s pipeline is focused on aldosterone-driven conditions:
- Launch-HTN (Phase III): Achieved compelling systolic blood pressure reductions in uncontrolled or resistant hypertension patients.
- Advance-HTN (Phase II): Met efficacy and safety endpoints in a specialist patient population.
- Explore-CKD (Phase II): Demonstrated robust blood pressure and kidney-protection benefits (SBP and albuminuria reductions).
- Explore-OSA (Phase II): Currently underway to assess efficacy in obstructive sleep apnea with hypertension.
Recent Developments
01
Positive topline results from the pivotal Launch-HTN (Phase III) and Advance-HTN (Phase II) trials of lorundrostat in uncontrolled/resistant hypertension (Mar 10, 2025).
02
Pivotal data published and presented: Advance-HTN in NEJM (Apr 23, 2025) and late-breaking at ACC.25; Launch-HTN in JAMA (Jun 30, 2025) and late-breaking at ESH 2025.
03
Positive topline from Explore-CKD (Phase II): lorundrostat 25 mg QD met the primary endpoint with a –9.3 mmHg SBP reduction (–7.5 mmHg placebo-adjusted; p=0.0024) and reduced UACR (Jun 17, 2025).
Key Milestones for 2025
- Pre-NDA meeting with FDA (Q4 2025).
- Advance NDA-preparation activities following pivotal results (H2 2025).
- Continue execution of Explore-OSA (Phase II) in OSA with hypertension (ongoing through H2 2025; topline expected 1H 2026).
Strategic Priorities
- Advance pivotal and proof-of-concept trials of lorundrostat across hypertension, CKD, and OSA.
- Maintain disciplined cash management to extend runway into 2027 and support regulatory submissions.
- Prepare for NDA filing in the fourth quarter of 2025 or the first quarter of 2026 by strengthening clinical, regulatory, and commercial readiness.
- Evaluate selective partnerships to broaden R&D capabilities and accelerate development.
Cash Reserves Utilization
Mineralys held $198.2 million in cash and equivalents at year-end 2024, which increased to $324.9 million by mid-2025. These reserves are earmarked to fund ongoing Phase II and III trials, advance NDA-enabling activities, and cover operating expenses, ensuring a financial runway through 2027.
Strategic Partnerships
Mineralys has an in-licensing agreement with Mitsubishi Tanabe Pharma for lorundrostat, its lead aldosterone synthase inhibitor. Beyond this, the company has not disclosed additional partnerships but has indicated openness to collaborations that align with its cardio-renal-metabolic strategy.
Strengths:
Robust cash reserves with runway into 2027; late-stage clinical pipeline led by lorundrostat showing positive pivotal trial results.
Weaknesses:
Ongoing reliance on financing and partnerships to sustain R&D and operations until commercialization milestones are achieved.
Opportunities:
Significant addressable markets in hypertension, chronic kidney disease, and obstructive sleep apnea, with high unmet medical need.
Threats:
Intense competition in the cardio-renal-metabolic space; potential regulatory and clinical development risks.
This comprehensive profile underscores Mineralys Therapeutics’ positioning as a focused biopharmaceutical company in cardio-renal-metabolic diseases, highlighting both its strong financial foundation and clinical progress while acknowledging the challenges of commercialization and competitive pressures.
Senior Management Team
Jon Congleton
Chief Executive Officer & President
Jon has served as CEO and Board member at Mineralys since November 2020. Prior to Mineralys, he led Impel NeuroPharma (CEO, 2017–2020) and Nivalis Therapeutics (CEO, 2015–2017). With over 18 years at Teva Pharmaceutical in senior roles Jon brings extensive commercial and leadership expertise across CNS and other therapeutic areas. He holds a B.S. in Marketing from Kansas State University.
Dr David Rodman
Chief Medical Officer
David joined Mineralys in January 2021. He previously held leadership positions at miRagen, Vertex Pharmaceuticals, and Novartis Institutes for BioMedical Research. A recognized leader in cardiovascular research, he is an ASCI member and AHA Fellow. Dr. Rodman received his M.D. from the University of Pennsylvania and completed board certifications in Internal Medicine, Pulmonary Medicine, and Critical Care at the University of Colorado.
Adam Levy
Chief Financial Officer & Chief Business Officer
Adam has been CFO and CBO since March 2022. His prior roles include CFO at Sanifit Therapeutics (until its acquisition by Vifor Pharma), CBO at Brickell Biotech, and similar leadership roles at miRagen Therapeutics. He also has a strong background in biotech investment banking with Merrill Lynch, Jefferies, and Wedbush, supporting over $30 billion in financings and M&A. Adam holds a B.S. in Business Management and Marketing from Cornell University.
Eric Warren
Chief Commercial Officer
Appointed in April 2025, Eric brings nearly 30 years of pharma experience, including his most recent role as CCO at Esperion Therapeutics. He started his career as a pharmacist and has held commercial leadership positions at Merck, Genzyme, Pfizer, Sanofi, and Nabriva. Eric holds a B.S. in Pharmacy and is a licensed pharmacist in New York State.