We are a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Our product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that we are initially developing for the treatment of patients with uncontrolled hypertension (uHTN), defined as individuals who are unable to achieve BP of below 130/80 mmHg despite taking two or more lines of antihypertensive medication or resistant hypertension (rHTN), defined as individuals who are unable to achieve BP of below 130/80 mmHg despite taking three or more antihypertensive medications typically including a diuretic. In the United States, there are over 115 million patients who have sustained elevated blood pressure (BP), or hypertension and more than half of this population fails to achieve their BP goals, defined as BP of 130/80 mmHg, with currently available medications. There are over 30 million treated patients who do not achieve their BP goal, of whom approximately 20 million have systolic BP 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 a Phase 2 clinical trial evaluating 200 subjects with uHTN and rHTN (Target-HTN), lorundrostat demonstrated a clinically meaningful and statistically significant reduction in BP with once-daily dosing and was well tolerated. In addition to hypertension, we intend to develop lorundrostat for the treatment of chronic kidney disease (CKD) and believe that our product candidate holds promise to be an innovative solution for the rapidly growing unmet need in multiple cardiorenal disorders. Hypertension is one of the most common medical conditions globally, afflicting approximately 1.3 billion people and resulting in an estimated average of $130 billion annual economic burden in the United States alone between 2003 and 2014. Despite the availability of multiple treatment options, including thiazide diuretics, angiotensin-converting enzyme (ACE)-inhibitors, angiotensin II receptor blockers (ARBs), calcium channel blockers, beta blockers, and mineralocorticoid receptor antagonists (MRAs), the prevalence of uHTN continues to grow, further exacerbated by the rapidly rising rate of obesity. Over 30 million hypertensive patients in the United States are unable to achieve their BP goal despite treatment. Within this population there are approximately 10.3 million patients suffering from rHTN. Multiple large-scale studies have demonstrated that patients who fail to achieve their BP goal have a significantly elevated risk of developing heart disease, stroke and kidney disease (Wright JT Jr, et al. A randomized trial of intensive versus standard blood-pressure control. N Engl J Med. 2015;373(22):2103-2116; and Zhou, et al., Uncontrolled Hypertension Increases Risk of All-Cause and Cardiovascular Disease Mortality in US Adults: the NHANES III Linked Mortality Study. Scientific Reports, 2018;8(1):1-7). Patients with rHTN have a 1.5 and 2.3 times higher risk than normotensive patients for composite cardiovascular events and end-stage renal disease, respectively. Notwithstanding this significant and growing unmet need, there has been a lack of U.S. Food and Drug Administration (FDA)-approved novel therapies targeting hypertension, with no new class of antihypertensive treatment approved within the last fifteen years. Abnormally elevated aldosterone levels are a key factor in driving hypertension in approximately 25% of hypertensive patients. Developing an effective hypertension therapy that targets aldosterone synthase remains a significant challenge, given the tight homology between the enzymes that regulate aldosterone and cortisol synthesis, as well as aldosterone’s role in regulating potassium. Several large pharmaceutical companies have tried to develop ASIs, but their efforts have been hampered due to insufficient selectivity for aldosterone, resulting in off-target toxicities associated with cortisol inhibition. These challenges have led to the discontinuation of many ASIs in development to date. We were originally founded as a Delaware corporation on May 31, 2019 under the name Catalys SC1, Inc. On May 29, 2020, we changed our name to Mineralys Therapeutics, Inc. Our principal executive offices are located at 150 N. Radnor Chester Road, Suite F200, Radnor, PA.
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Here are 1-2 brief analogies for Mineralys Therapeutics (MLYS):
Vertex Pharmaceuticals for aldosterone-driven hypertension (as Vertex revolutionized treatment for specific genetic diseases like Cystic Fibrosis with novel drug classes, Mineralys aims to do so for a specific subset of hypertension).
Early-stage Novo Nordisk, but focused on revolutionizing high blood pressure treatment (like Novo Nordisk transformed diabetes/obesity care with new drug classes, Mineralys is aiming to transform a major chronic disease with a novel mechanism for hypertension).
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- Lorundrostat: An investigational, highly selective aldosterone synthase inhibitor (ASI) in development for the treatment of uncontrolled hypertension.
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Mineralys Therapeutics (symbol: MLYS) is a clinical-stage biopharmaceutical company focused on developing novel therapies for cardiorenal diseases, particularly uncontrolled hypertension. Their lead product candidate, lorundracon, an aldosterone synthase inhibitor, is currently in clinical development (Phase 3 trials).
As a clinical-stage company, Mineralys Therapeutics does not yet have any commercialized products available for sale on the market. Therefore, they do not currently have "major customers" in the traditional sense of companies or individuals purchasing their therapeutics. Their primary activities are research and development, funded through investments and potential partnerships.
Should lorundracon receive regulatory approval and be commercialized in the future, Mineralys Therapeutics would likely sell its product primarily to other companies, such as:
- Pharmaceutical wholesalers and distributors (e.g., McKesson Corporation, AmerisourceBergen Corporation, Cardinal Health, Inc.)
- Integrated delivery networks and hospital systems
- Retail pharmacies
Alternatively, Mineralys Therapeutics might choose to license its product to a larger pharmaceutical company, in which case that company would become their primary partner/customer responsible for commercialization and sales to end-users or distributors.
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Jon Congleton, Chief Executive Officer
Jon Congleton joined Mineralys Therapeutics as CEO in 2020. He has over 30 years of experience in biopharmaceutical company leadership, including pipeline development, commercial strategy, and general management. [6] Prior to Mineralys, he served as President and CEO of Impel NeuroPharma, a private biotech company focused on CNS disorders. [11] Before that, he was CEO of Nivalis Therapeutics, which he took public in 2015. [6, 11] Mr. Congleton also held multiple roles at Teva Pharmaceuticals, where he was part of the original team that launched Copaxone. [11] Mineralys Therapeutics was founded in 2019 with a focus on aldosterone-driven cardio-renal-metabolic diseases. [3]
Adam Levy, Chief Financial Officer
Adam Levy has served as Chief Financial Officer and Chief Business Officer of Mineralys Therapeutics since March 2022, though his role was updated to solely Chief Financial Officer in January 2024. [7, 9, 15] He brings over two decades of operational and transactional experience in biotech and investment banking. [7] Before joining Mineralys, Mr. Levy was the Chief Financial Officer at Sanifit Therapeutics until its acquisition by Vifor Pharma in 2022. [5, 7, 9, 12] Previously, he was the Chief Business Officer at Brickell Biotech, where he oversaw the company's financial operations as it became a publicly listed company on Nasdaq. [5, 7, 9] He also served as Chief Business Officer at miRagen Therapeutics, guiding the company through multiple capital raises and a Nasdaq listing. [5, 7, 9] Between 2000 and 2016, Mr. Levy held investment banking positions at Merrill Lynch, Jefferies Group, and Wedbush Securities, completing over $30 billion in financings and M&A transactions for clients. [5, 7, 12]
David Rodman, Chief Medical Officer
Dr. David Rodman is the Chief Medical Officer at Mineralys Therapeutics. [1] He is an experienced industry and academic leader with over 15 years of leadership experience in the pharmaceutical and biotechnology industries, preceded by 15 years of academic medical experience. [6] His experience provides strategic direction for Mineralys as it advances its investigational process for MLS-101. [6]
Eric Warren, Chief Commercial Officer
Eric Warren serves as the Chief Commercial Officer for Mineralys Therapeutics. [1] No additional background information on him was found in the provided search results.
Jessica Ibbitson, Executive Vice President, Operations
Jessica Ibbitson holds the position of Executive Vice President, Operations at Mineralys Therapeutics. [1] No additional background information on her was found in the provided search results.
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<h3>Key Risks to Mineralys Therapeutics (MLYS)</h3>
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<strong>Single-Asset Dependence and Regulatory/Clinical Trial Risks:</strong> Mineralys Therapeutics' future is entirely dependent on the successful development and regulatory approval of its sole product candidate, lorundrostat. There is no assurance that the U.S. Food and Drug Administration (FDA) will approve lorundrostat, or that the outcome of regulatory meetings will go as expected. Delays in the commencement, enrollment, or completion of clinical trials, or unfavorable results from ongoing or future studies (such as the Phase 2 EXPLORE-OSA study expected in Q1 2026), could severely harm the business. Additionally, unexpected adverse side effects or inadequate efficacy of lorundrostat could limit its development, regulatory approval, and/or commercialization.</li>
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<strong>Financial Risks and Potential for Shareholder Dilution:</strong> As a clinical-stage biopharmaceutical company, Mineralys Therapeutics has no revenue and incurs significant expenses related to research, development, manufacturing, and pre-commercialization activities. The company relies on external funding to finance its operations, and its ability to continue as a going concern is contingent on its ability to raise additional capital. Past public offerings and shelf registrations indicate a potential for future fundraising, which could lead to significant dilution for existing shareholders.</li>
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<strong>Safety and Tolerability Profile of Lorundrostat:</strong> While lorundrostat has demonstrated a favorable safety and tolerability profile in clinical trials, the Phase 3 Launch-HTN trial noted that hyponatremia (low sodium levels), hyperkalemia (high potassium levels), and reduced kidney function occurred more frequently in the treatment arm compared to placebo. Although discontinuation rates due to adverse events remained low (<1%), these side effects could still raise concerns during regulatory review or impact the drug's commercial adoption by physicians and patients.</li>
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The emergence and increasing adoption of device-based therapies for resistant and uncontrolled hypertension, such as renal denervation systems (e.g., Medtronic's Symplicity Blood Pressure Procedure and Recor Medical's Paradise System), represent a clear emerging threat. These therapies offer a non-pharmacological alternative to medication, directly competing for the same patient population that Mineralys Therapeutics aims to treat with its lead candidate, lorundraconstat.
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Mineralys Therapeutics' primary product is lorundrostat, a selective aldosterone synthase inhibitor (ASI) developed to treat hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA).
The addressable markets for lorundrostat are estimated as follows:
- The global antihypertensive market is valued at $40 billion.
- For resistant hypertension, a subset of hypertension, the market opportunity is estimated at $5.2 billion (U.S.).
- In the United States, 7-8 million patients could benefit from lorundrostat for obesity-related hypertension.
- The combined global market for hypertension, CKD, and OSA therapies is projected to exceed $200 billion by 2030.
- The global market for obstructive sleep apnea (OSA) was $4.5 billion in 2023 and is expected to reach $6.9 billion by 2030.
- Analysts have projected lorundrostat could achieve approximately $2.8 billion in worldwide non-risk-adjusted peak sales, or about $1.1 billion in risk-adjusted peak sales, by 2040. Other forecasts suggest lorundrostat sales could reach $601 million globally in 2030.
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Mineralys Therapeutics (MLYS) is poised for significant future revenue growth over the next 2-3 years, primarily driven by the commercialization and expanded applications of its lead product candidate, lorundrostat. The company's strategic focus on aldosterone-driven diseases, coupled with positive clinical trial outcomes, underpins these expectations.
Here are 3-5 expected drivers of future revenue growth for Mineralys Therapeutics:
- Approval and Commercial Launch of Lorundrostat for Hypertension: The most immediate and substantial driver of future revenue growth for Mineralys Therapeutics is the anticipated regulatory approval and subsequent commercial launch of lorundrostat for uncontrolled and resistant hypertension. Positive results from the pivotal Phase 3 Launch-HTN and Advance-HTN trials have positioned lorundrostat for a pre-New Drug Application (NDA) meeting with the FDA in the fourth quarter of 2025 and an NDA filing in late 2025 or early 2026. Assuming regulatory approval, a commercial launch is projected for 2027. The significant unmet medical need in the estimated 15-20 million U.S. patients with uncontrolled hypertension, combined with surveys indicating a high likelihood of physician prescription, suggests a robust market opportunity upon launch.
- Expansion of Lorundrostat's Indications to Include Chronic Kidney Disease (CKD): Beyond hypertension, the successful development of lorundrostat for additional indications, such as chronic kidney disease (CKD), is a key growth driver. The Phase 2 Explore-CKD trial delivered positive topline data in the second quarter of 2025, demonstrating statistically significant reductions in both blood pressure and albuminuria in patients with CKD. This expansion into a comorbidity frequently associated with hypertension significantly broadens the addressable patient population for lorundrostat, thereby increasing its potential revenue streams.
- Expansion of Lorundrostat's Indications to Include Obstructive Sleep Apnea (OSA): The ongoing Phase 2 Explore-OSA trial, which completed enrollment in the first quarter of 2025, represents another important market expansion opportunity. Topline results for this trial, evaluating lorundrostat in patients with moderate-to-severe obstructive sleep apnea and hypertension, are anticipated in the first quarter of 2026. Positive outcomes in this trial would further diversify the therapeutic utility of lorundrostat and unlock additional revenue potential by addressing another substantial unmet medical need linked to dysregulated aldosterone.
- Strategic Partnerships for Ex-U.S. Commercialization: Mineralys Therapeutics has emphasized its efforts to secure strategic partnerships, particularly for commercialization activities outside the U.S. These collaborations are crucial for expanding lorundrostat's market reach beyond the domestic market and leveraging external expertise and resources for global distribution. Such partnerships would contribute to accelerated revenue generation through licensing agreements, milestone payments, and shared profits from international sales.
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Share Issuance
- Mineralys Therapeutics completed its initial public offering (IPO) in February 2023, raising approximately $192.0 million in gross proceeds from the sale of 12,000,000 shares at $16.00 per share.
- In February 2024, the company executed a private placement (PIPE) financing, selling approximately 8.9 million shares for gross proceeds of about $120 million.
- Mineralys Therapeutics closed an upsized public offering in September 2025, which generated approximately $287.5 million in gross proceeds, including the full exercise of the underwriters' option to purchase additional shares.
Inbound Investments
- The company raised $40 million in a Series A financing round in 2021.
- Mineralys secured $118 million through a Series B financing round in 2022.
- A $120 million private placement financing was completed in February 2024, led by new investor TCGX and existing investor RA Capital Management, with participation from other institutional investors.
Capital Expenditures
- The primary focus of capital allocation has been the clinical development of its lead product candidate, lorundrostat.
- Funds are consistently directed towards research and development, manufacturing, and pre-commercialization activities for lorundrostat.
- The capital-intensive nature of clinical trials and drug development is reflected in the company's financials, including a reported free cash flow of -$122 million.
