Summary of Mineralys Therapeutics FY Conference Call Company Overview - **Company**: Mineralys Therapeutics (NasdaqGS:MLYS) - **Event**: FY Conference on November 11, 2025 - **Key Speaker**: Jon Congleton, CEO Industry Context - **Industry**: Hypertension treatment and drug development - **Unmet Need**: Hypertension remains a leading modifiable risk factor globally, causing approximately 10.8 million deaths annually due to related comorbidities [4][5][6] Core Points and Arguments 1. **Hypertension Treatment Landscape**: - There has been a lack of innovation in hypertension treatments over the past 20-25 years, with existing therapies not adequately addressing patient needs, particularly regarding dysregulated aldosterone [5][36] - Current treatment goals have become more stringent, with the target blood pressure now set at 130/80 mmHg for most patients and 120 mmHg for those with comorbidities [5] 2. **Lorundrostat's Mechanism and Efficacy**: - Lorundrostat is positioned as a best-in-class aldosterone synthase inhibitor (ASI) with a selectivity ratio of 374:1 for aldosterone over cortisol, which is critical for minimizing side effects [9][42] - Clinical trials (ADVANCE HTN and LAUNCH HTN) show significant blood pressure reductions of 15-19 mmHg, which are transformative compared to typical improvements of 5-6 mmHg seen with other agents [15][31] 3. **Market Opportunity**: - The potential market for lorundrostat is estimated at 20 million patients in the U.S., with 10 million classified as resistant hypertension and another 10 million as uncontrolled hypertension [36][37] - There is a strong demand for innovative treatments, with 95% of surveyed physicians indicating intent to prescribe lorundrostat if available [38] 4. **Safety Profile**: - Lorundrostat has a favorable safety profile, with lower rates of hyperkalemia compared to competitors, which may be attributed to its selectivity and pharmacokinetics [41][42] 5. **Regulatory Timeline**: - Mineralys plans to file for regulatory approval by the end of 2025 or Q1 2026, with expectations of overlapping review cycles with competitors like AstraZeneca [43] Additional Important Insights - **Patient Demographics**: The ADVANCE HTN study included a significant proportion (53%) of Black or African American patients, who are known to have more challenging hypertension profiles [28] - **Measurement Techniques**: The study utilized multiple blood pressure measurement methods, including 24-hour ambulatory monitoring, to ensure accurate assessment of treatment efficacy [16][17] - **Physician Engagement**: The company has conducted market research indicating that physicians are primarily focused on absolute blood pressure changes rather than placebo-adjusted figures, which influences prescribing behavior [31][32] This summary encapsulates the key points discussed during the conference call, highlighting the strategic positioning of Mineralys Therapeutics in the hypertension treatment landscape and the promising potential of lorundrostat as a novel therapeutic option.

RT Valerie Anne Smith (@ValerieAnne1970)The American Heart Assn. Has Changed 'Normal' Blood Pressure To 110/70...Every Time They Lower The Numbers, Millions Of People Need Drugs.In 1970, Normal BP Was 160/95. In 1985 It Was 140/90. And Now 120/80 Is Considered 'Elevated.'That's Not Medicine. That's $40B Marketing.The bar has been lowered once again & under new guidelines, more Americans meet the criteria for high blood pressure & are pressured to start taking antihypertensive medications.The AHA & ACC (Amer ...

Clinical Trial Results - Mineralys Therapeutics 的一种实验性药物显著降低了治疗抵抗性高血压患者的血压 [1] - 一些患者因副作用停止服用该药物 [1]

Health Disparities and Hypertension Crisis - Health disparities are significant, with chronic diseases like hypertension disproportionately affecting black and brown communities, leading to higher rates of heart attacks, strokes, and kidney disease [1] - Globally, 13 亿 (13 billion) people are affected by hypertension, and 50% are unaware they have it [3] - In the US, 58% of black adults have hypertension, but only one in five receive adequate treatment [3][4] - Hypertension in children has doubled over the last decade, making it no longer just an adult issue [4] - Complication and death rates from hypertension are two to three times higher in predominantly black communities like Roxbury compared to white communities [5] The Power of Storytelling in Health Education - Storytelling is a powerful tool to open eyes, unlock emotions, and connect people to a shared humanity, making complex health information accessible and relatable [1][8] - Marrying health literacy to storytelling from an early age can lead to transformational and lifesaving results [3] - When children read health stories, especially with their families, they learn, remember, and become change agents for health in their families [6] - Comprehension and recall increases by 33% through storytelling [8] Blueprint for Transforming Generational Health (The Five Es) - Engage Early: Exposing children to health education by age eight makes them twice as likely to make healthy lifelong choices [7] - Engage with Story: Knowledge is power, and stories simplify complex ideas [8] - Empower Positive Mindset: Children who believe they can make a difference are twice as likely to make good health choices [9] - Enrich with Ongoing Learning: Learning about health should happen everywhere and every day [9] - Enlist Community Action: Positive behaviors increase by 25% when kids take health information home [10]

Company Overview - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing medicines targeting hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases driven by dysregulated aldosterone [3] - The company's initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor aimed at treating cardiorenal conditions affected by dysregulated aldosterone [3] Financial Results Announcement - Mineralys Therapeutics will report its financial results for the first quarter ended March 31, 2025, after the financial markets close on May 12, 2025 [1] - A live conference call will take place on May 12 at 4:30 p.m. ET, with details provided for both domestic and international participants [2]

Core Insights - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases related to dysregulated aldosterone [1][3] - The company will host a conference call featuring Dr. Luke Laffin from the Cleveland Clinic to discuss results from the Advance-HTN and Launch-HTN clinical trials, highlighting the unmet medical needs in uncontrolled and resistant hypertension [1] Company Overview - Mineralys Therapeutics is based in Radnor, Pennsylvania, and was founded by Catalys Pacific [3] - The company's lead product candidate, lorundrostat, is an orally administered, highly selective aldosterone synthase inhibitor aimed at treating cardiorenal conditions influenced by dysregulated aldosterone [3] Upcoming Events - A conference call and webinar will take place on April 1st at 8:00 a.m. ET, where a live webcast will also be available on the company's Investor Relations page [2]