Business Overview and History
Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other conditions driven by dysregulated aldosterone. The company's lead product candidate, lorundrostat, is a highly selective aldosterone synthase inhibitor (ASI) being evaluated for the treatment of these cardiorenal metabolic disorders.
Mineralys Therapeutics, Inc. was incorporated as a Delaware corporation in May 2019 with the goal of developing medicines targeting diseases driven by dysregulated aldosterone, including hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA). The company's initial focus has been on the development of its lead product candidate, lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI).
In July 2020, Mineralys entered into an exclusive, worldwide license agreement with Mitsubishi Tanabe Pharmaceutical Corporation to develop and commercialize lorundrostat. Since its inception, the company has devoted substantially all of its resources to organizing and staffing, business planning, raising capital, establishing its intellectual property portfolio, and conducting research, preclinical studies, and clinical trials for lorundrostat.
As of December 31, 2024, Mineralys had an accumulated deficit of $302.5 million, reflecting the significant investments made in advancing lorundrostat through clinical development. The company's clinical development efforts for lorundrostat have faced some challenges. In the initial Phase 2 proof-of-concept Target-HTN trial, Mineralys encountered issues with patient enrollment and adherence to the 24-hour ambulatory blood pressure monitoring protocol, which required adjustments to the statistical analysis plan. However, the Target-HTN trial ultimately demonstrated that lorundrostat could provide clinically meaningful reductions in blood pressure in patients with uncontrolled or resistant hypertension.
Building on the learnings from Target-HTN, Mineralys initiated its pivotal clinical program for lorundrostat in 2023, including the Advance-HTN and Launch-HTN trials. These trials were designed with more rigorous enrollment criteria and blood pressure measurement protocols to generate high-quality data to support potential regulatory approval. As of the end of 2024, Mineralys had completed enrollment in both the Advance-HTN and Launch-HTN trials, putting the company on track to report topline data in the first half of 2025.
Financials and Liquidity
As of December 31, 2024, Mineralys reported cash, cash equivalents, and investments of $198.2 million, which the company believes will be sufficient to fund its planned clinical studies and support corporate operations through the first quarter of 2026. The company's cash and cash equivalents specifically stood at $114.09 million at the end of 2024.
For the full year 2024, Mineralys reported a net loss of $177.8 million, compared to a net loss of $71.9 million in 2023. The increase in net loss was primarily driven by a $98.2 million rise in research and development expenses, as the company advanced its lorundrostat clinical program, as well as a $9.5 million increase in general and administrative expenses.
Mineralys' research and development expenses for the fourth quarter of 2024 were $44.6 million, up from $23.7 million in the same period of 2023. General and administrative expenses for the fourth quarter of 2024 were $7.2 million, compared to $4.0 million in the prior-year quarter. The company's total other income, net, was $14.6 million for the full year 2024, up from $12.8 million in 2023.
In the fourth quarter of 2024, Mineralys reported a net loss of $48.9 million. The company has not yet generated any revenue, as lorundrostat is still in clinical development. For the year ended December 31, 2024, Mineralys reported net cash used in operating activities of $166.3 million as it continues to advance the development of lorundrostat through its ongoing and planned clinical trials.
Mineralys has a debt-to-equity ratio of 0, indicating that the company has not taken on any significant debt to finance its operations. As a clinical-stage company, Mineralys expects to continue incurring substantial losses as it advances lorundrostat's development and is focused on securing the necessary funding, whether through equity offerings, debt financing, or potential collaborations, to support the continued research and development of lorundrostat and any future product candidates.
Clinical Pipeline and Milestones
Mineralys' lead product candidate, lorundrostat, is currently being evaluated in two pivotal trials for the treatment of uncontrolled or resistant hypertension:
1. Advance-HTN (Phase 2): This trial completed enrollment of 285 subjects in the fourth quarter of 2024 and is designed to evaluate the efficacy and safety of lorundrostat as an add-on therapy to a standardized background treatment of two or three antihypertensive medications. Topline data from this trial is anticipated in March 2025.
2. Launch-HTN (Phase 3): This global, randomized, double-blind, placebo-controlled trial completed enrollment of 1,083 subjects in the fourth quarter of 2024. It is evaluating the efficacy and safety of lorundrostat as an add-on therapy to patients' existing, prescribed background treatment of two to five antihypertensive medications. Topline data is expected in the mid-first half of 2025.
In addition to the hypertension trials, Mineralys is also advancing lorundrostat in the following indications:
- Explore-CKD (Phase 2): This randomized, double-blind, placebo-controlled trial is evaluating the safety and efficacy of lorundrostat in patients with stage 2-3b CKD and albuminuria despite receiving stable treatment with an ACE inhibitor or ARB, and an SGLT2 inhibitor. Enrollment in this trial was completed in the first quarter of 2025, and topline data is anticipated in the second quarter of 2025.
- Explore-OSA (Phase 2): This placebo-controlled, crossover trial will evaluate the effect of lorundrostat in the treatment of subjects with moderate-to-severe obstructive sleep apnea and hypertension. The trial is expected to initiate in the first quarter of 2025.
Product Segments and Market Opportunity
Mineralys Therapeutics is focused on developing lorundrostat for multiple indications where dysregulated aldosterone plays a key role:
Hypertension: In the United States, there are approximately 120 million patients with sustained elevated blood pressure, or hypertension. More than half of this population fails to achieve their blood pressure goals (defined as BP below 130/80 mmHg) with currently available medications. Over 30 million treated patients do not achieve their blood pressure goal, of whom approximately 20 million have systolic blood pressure levels greater than 140 mmHg. Patients with hypertension that persists despite taking two or more medications have 1.8 and 2.5 times greater mortality risk due to either cardiovascular disease or stroke, respectively.
In the Target-HTN Phase 2 trial, the 50 mg QD dose of lorundrostat showed an 8-10 mmHg reduction in systolic blood pressure, which was highlighted as a favorable result. This trial evaluated 200 subjects with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), demonstrating clinically meaningful and statistically significant reduction in blood pressure with once-daily dosing and good tolerability.
Chronic Kidney Disease: Mineralys is investigating the benefits of lorundrostat in subjects with hypertension and CKD. Patients with uncontrolled hypertension despite treatment have a significantly higher risk of developing CKD. Lorundrostat's ability to reduce blood pressure, as well as its potential renal protective effects, make it a promising candidate for treating hypertension in the CKD population.
Obstructive Sleep Apnea: The company is also exploring the use of lorundrostat in subjects with hypertension and OSA. Hypertension is a common comorbidity in patients with OSA, and dysregulated aldosterone has been linked to OSA pathogenesis. Lorundrostat's mechanism of action may help alleviate both the hypertension and upper airway obstruction associated with OSA.
Risks and Challenges
As a clinical-stage biopharmaceutical company, Mineralys faces several risks and challenges common to the industry, including:
- Uncertainty around the successful development and regulatory approval of lorundrostat: The company's future success is highly dependent on the clinical development and regulatory approval of its lead product candidate. Delays or failures in this process could significantly impact the company's prospects.
- Potential competition: Mineralys may face competition from other companies developing treatments for hypertension, CKD, and OSA, which could impact the commercial potential of lorundrostat.
- Reliance on third-party manufacturers and suppliers: The company does not have its own manufacturing capabilities and is dependent on third-party manufacturers, which introduces supply chain and other risks.
- Need for additional financing: Mineralys may require additional capital to fully execute its clinical development and commercialization plans for lorundrostat, which could result in dilution to shareholders or other unfavorable terms.
- Potential for adverse events or safety concerns with lorundrostat: Any safety issues or unfavorable side effect profiles could limit the drug's commercial potential or lead to regulatory setbacks.
Outlook and Conclusion
Mineralys Therapeutics is a promising clinical-stage biopharmaceutical company focused on addressing the significant unmet need in hypertension and related cardiorenal metabolic disorders. With its lead product candidate, lorundrostat, currently in late-stage clinical development, the company is well-positioned to potentially bring a novel therapy to market for patients struggling with uncontrolled or resistant hypertension.
The anticipated topline data readouts from the Advance-HTN and Launch-HTN trials in 2025 will be key milestones for the company, potentially validating lorundrostat's efficacy and safety profile. Additionally, the Explore-CKD and Explore-OSA trials represent opportunities for Mineralys to expand the drug's potential into additional indications where dysregulated aldosterone plays a central role.
While Mineralys faces the typical risks and challenges associated with a clinical-stage biotech company, its robust pipeline, experienced management team, and strong financial position provide a solid foundation for the company to execute on its strategic objectives. The company's current cash position is expected to fund operations through the first quarter of 2026, providing runway for multiple key clinical readouts.
Investors will be closely watching Mineralys' progress in the coming year as it aims to bring novel solutions to patients suffering from hypertension and related cardiorenal conditions. The success of lorundrostat in its ongoing clinical trials could potentially address a significant market opportunity, given the large population of patients with uncontrolled hypertension and related conditions.