Mineralys Therapeutics (NasdaqGS:MLYS) FY Conference Transcript

Summary of Mineralys Therapeutics FY Conference Call Company Overview - Company: Mineralys Therapeutics (NasdaqGS:MLYS) - Focus: Development of lorundrostat, an aldosterone synthase inhibitor for treating hypertension and related conditions Key Points Clinical Development and NDA Filing - Mineralys has built a comprehensive clinical development program in 2023 and 2024, with three significant data readouts this year [2][3] - Two pivotal studies, Advance-HTN and Launch-HTN, demonstrated profound reductions in blood pressure with a safe profile, forming the basis for the NDA application [2][3] - The NDA filing is anticipated by the end of 2025 or the first quarter of 2026, including data from pivotal studies and open-label extensions [5][15] Market Opportunity - There are approximately 20 million patients in the U.S. struggling to achieve blood pressure goals, representing a significant market for lorundrostat [3][9] - The target population includes patients on two or more medications who are not reaching their goals, specifically those with resistant hypertension [9] Commercial Strategy - An estimated 400 sales representatives may be needed to effectively reach the 60,000 doctors who control 50% of the prescription market for third-line hypertension treatments [9][10] - The company has $594 million in cash, which is expected to support pre-commercialization efforts and the launch through 2027, but will not lead to profitability [11][14] Competitive Landscape - Mineralys is preparing for competition with AstraZeneca's baxdrostat, which is expected to launch around Q2 2026 [20][22] - The company is focused on building awareness and enthusiasm for lorundrostat among healthcare providers and payers, emphasizing its clinical profile and benefits [22][26] Clinical Data and Efficacy - The clinical trials have shown not only blood pressure reduction but also benefits in proteinuria, which is critical for patients with comorbid conditions [26] - The diversity of the patient population in trials is highlighted, with significant representation of Black or African-American patients, which is crucial for addressing health disparities [26][27] Future Catalysts - The next significant data readout will be from the Explore OSA trial, expected in Q1 2026, which examines the drug's effects on patients with obstructive sleep apnea [28][29] Partnership and Development - Ongoing discussions for potential partnerships are focused on enhancing the value of lorundrostat and expanding its indication profile [38][39] - The company is evaluating various scenarios for commercialization and development partnerships, which could significantly impact capital needs [14][38] Regulatory Considerations - The company has been in discussions with the FDA regarding the long-term safety profile of lorundrostat, which is critical for the NDA submission [6][8] Conclusion - Mineralys Therapeutics is positioned to launch lorundrostat in a competitive market, with a strong clinical data set and a clear strategy for commercialization and market penetration. The upcoming NDA filing and ongoing clinical trials will be pivotal in determining the company's future success.