Mineralys Therapeutics, Inc. (NASDAQ:MLYS) is a clinical-stage biopharmaceutical company at the forefront of developing innovative medicines to address the unmet needs in hypertension, chronic kidney disease (CKD), and other prevalent cardiovascular conditions driven by dysregulated aldosterone. With a focus on precision medicine, the company’s lead candidate, lorundrostat, has the potential to reshape the treatment landscape for these debilitating cardiorenal disorders.
Company History and Evolution
Mineralys Therapeutics was incorporated as a Delaware corporation in May 2019 with the mission to develop medicines targeting diseases driven by dysregulated aldosterone. The company’s lead clinical-stage product candidate, lorundrostat, is a proprietary, orally administered aldosterone synthase inhibitor. In July 2020, Mineralys entered into a pivotal license agreement with Mitsubishi Tanabe Pharmaceutical Company, securing exclusive, worldwide, royalty-bearing, sublicensable rights to develop and commercialize products incorporating lorundrostat. As part of this agreement, Mineralys paid Mitsubishi Tanabe a $1 million upfront fee and has made $9 million in development milestone payments to date.
In 2021 and 2022, Mineralys significantly bolstered its financial position by raising approximately $153 million in gross proceeds through the issuance of Series A and Series B convertible preferred stock. This capital infusion was crucial for advancing the development of lorundrostat, including the initiation of preclinical studies and early-stage clinical trials.
Like many young, clinical-stage biopharmaceutical companies, Mineralys faced initial challenges in establishing its intellectual property portfolio, building out its management team and infrastructure, and navigating the complex regulatory landscape to advance lorundrostat into the clinic. Despite these hurdles, the company successfully secured the licensing rights to lorundrostat and raised substantial capital to fund its research and development activities.
Since its inception, Mineralys has made significant strides in advancing lorundrostat through its clinical pipeline. In February 2023, the company successfully completed its initial public offering (IPO), raising $201.4 million in net proceeds to fund the ongoing development of its lead program. In February 2024, Mineralys further bolstered its financial position by securing $116.1 million in net proceeds from a private placement offering.
Financial Overview and Liquidity
As of September 30, 2024, Mineralys reported a robust cash, cash equivalents, and investments position of $263.6 million. This strong balance sheet has enabled the company to aggressively advance its clinical trials and support its overall operations. For the nine months ended September 30, 2024, Mineralys reported a net loss of $128.9 million, primarily driven by its increased research and development (R&D) investments, which totaled $124.0 million during this period.
The company’s R&D expenses have been primarily focused on the clinical development of lorundrostat, including the initiation and enrollment of its pivotal hypertension trials, Advance-HTN and Launch-HTN, as well as the ongoing Explore-CKD Phase 2 trial. Mineralys has also invested in expanding its team and enhancing its manufacturing capabilities to support the advancement of its clinical programs.
Despite the significant investment in R&D, Mineralys’ cash runway extends into 2026, according to management’s guidance. This financial flexibility positions the company to successfully execute on its clinical milestones and continue to develop its pipeline of targeted therapies for cardiorenal diseases.
For the fiscal year 2023, Mineralys reported no revenue and a net loss of $71.9 million. The company’s operating cash flow and free cash flow for 2023 were both negative $81.2 million. In the most recent quarter (Q3 2024), Mineralys again reported no revenue and a net loss of $56.3 million, with operating cash flow of negative $50.2 million and free cash flow of negative $50.2 million. The increase in net loss from Q3 2023 to Q3 2024 was primarily attributed to increased R&D expenses for the lorundrostat pivotal program.
As of September 30, 2024, Mineralys had $97.27 million in cash and cash equivalents. The company’s financial position is strong, with a debt-to-equity ratio of 0, a current ratio of 8.55, and a quick ratio of 8.55. Mineralys does not have any disclosed available credit lines. The company currently operates solely in the United States.
Pivotal Clinical Trials in Hypertension
Mineralys’ pivotal clinical program for lorundrostat in hypertension consists of two key trials: Advance-HTN and Launch-HTN. These studies are designed to evaluate the efficacy and safety of lorundrostat as an add-on therapy for the treatment of uncontrolled or resistant hypertension.
The Advance-HTN trial, which completed enrollment in the fourth quarter of 2024, is a randomized, double-blind, placebo-controlled Phase 2 study enrolling 261 subjects. The primary endpoint is the change in 24-hour ambulatory systolic blood pressure at week 12 from baseline for the active cohorts versus placebo. Topline data from this trial is anticipated in March 2025. The trial enrolled over 66% of subjects with a BMI ≥ 30, over 40% women, and over 50% Black or African-American. The study is 90% powered to detect a 7mmHg change in systolic blood pressure versus placebo.
The Launch-HTN trial, which also completed enrollment ahead of schedule in the fourth quarter of 2024, is a global, randomized, double-blind, placebo-controlled Phase 3 study targeting the enrollment of 1,000 subjects. The primary endpoint is the change in systolic blood pressure as measured by automated office blood pressure at week 6 for the pooled 50-milligram lorundrostat cohort compared to placebo. Topline data from this trial is expected in the mid-first half of 2025, which is earlier than the original timeline. The Launch-HTN trial is greater than 95% powered to detect a 7mmHg reduction in systolic blood pressure versus placebo.
Both Advance-HTN and Launch-HTN have been designed to address the significant unmet need in hypertension, particularly among patients with uncontrolled or resistant disease, who are at greater risk of adverse cardiovascular events. The trials have also been structured to identify potential predictors of enhanced response to lorundrostat, such as obesity, which was observed in the earlier Phase 2 Target-HTN study.
Explore-CKD Phase 2 Trial in Chronic Kidney Disease
In addition to its pivotal hypertension program, Mineralys is also evaluating lorundrostat in patients with hypertension and chronic kidney disease (CKD) through the Explore-CKD Phase 2 trial. This randomized, double-blind, placebo-controlled, crossover study is designed to assess the safety and efficacy of lorundrostat in reducing blood pressure and albuminuria in subjects with Stage 2 to 3b CKD and uncontrolled or resistant hypertension, despite stable treatment with an SGLT2 inhibitor.
Enrollment for the Explore-CKD trial is ongoing, and topline data is anticipated in the second quarter of 2025. The trial’s primary endpoint is the placebo-adjusted change from baseline in systolic blood pressure at week 4, with an exploratory endpoint evaluating the placebo-adjusted percent change from baseline in urine albumin-to-creatinine ratio at week 4.
This study aims to provide further evidence for the potential benefits of lorundrostat in the CKD population, where the modulation of aldosterone signaling may offer meaningful improvements in cardiovascular and renal outcomes for these high-risk patients.
Potential Risks and Catalysts
While Mineralys’ clinical development efforts have progressed well, the company faces several risks inherent to the biopharmaceutical industry. These include the potential for unfavorable results or delays in its ongoing and future clinical trials, regulatory hurdles, and competition from other hypertension and CKD therapies. Additionally, the company’s reliance on the successful commercialization of lorundrostat, if approved, introduces risks related to market adoption, pricing, and reimbursement.
Despite these risks, Mineralys’ upcoming clinical milestones present significant catalysts for the company. The anticipated topline data readouts from the Advance-HTN, Launch-HTN, and Explore-CKD trials in 2025 will be crucial in demonstrating the efficacy and safety of lorundrostat, potentially positioning the asset for regulatory approval and commercialization. Additionally, the company’s ongoing efforts to expand lorundrostat’s clinical utility beyond hypertension, such as in CKD, could further broaden the treatment landscape and drive long-term value creation.
Conclusion
Mineralys Therapeutics is at the forefront of developing innovative, targeted therapies for cardiorenal diseases. The company’s lead candidate, lorundrostat, has the potential to address the significant unmet need in hypertension and related conditions driven by dysregulated aldosterone. With a robust clinical pipeline, a strong financial position, and experienced management team, Mineralys is well-positioned to create long-term value for its shareholders as it continues to advance its precision medicine approach in the pursuit of improved outcomes for patients.
The company’s focus on lorundrostat as a potential treatment for both hypertension and CKD demonstrates a strategic approach to addressing interconnected cardiorenal conditions. The ongoing clinical trials, particularly the Advance-HTN and Launch-HTN studies, are designed with strong statistical power to detect clinically meaningful improvements in blood pressure control. The inclusion of diverse patient populations in these trials, such as those with obesity and from various ethnic backgrounds, may provide valuable insights into the drug’s efficacy across different patient subgroups.
As Mineralys progresses towards key data readouts in 2025, investors and the medical community will be closely watching for the results that could potentially reshape the treatment paradigm for hypertension and CKD. The company’s solid financial footing, with no debt and a substantial cash position, provides a runway to navigate the critical phases of clinical development and potential commercialization efforts.
While Mineralys faces the typical risks associated with clinical-stage biopharmaceutical companies, including the uncertainty of trial outcomes and regulatory approvals, the potential market opportunity for an effective treatment in hypertension and CKD is substantial. The company’s focused approach on aldosterone modulation and its well-designed clinical program position it as a noteworthy player in the cardiorenal space, with the potential to deliver significant value to both patients and shareholders in the coming years.
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