Summary of Mineralys Therapeutics Conference Call Company Overview - **Company**: Mineralys Therapeutics (NasdaqGS: MLYS) - **Focus**: Development of aldosterone synthase inhibitors (ASI) targeting cardiorenal metabolic disorders, primarily hypertension [1][2] Industry Context - **Market Opportunity**: Approximately 20 million patients in the U.S. suffer from resistant and uncontrolled hypertension, with 10 million specifically identified as resistant hypertension patients [4][5] - **Competitive Landscape**: The ASI class is emerging as a new treatment option for hypertension, with recent data from competitors like AstraZeneca's Baxdrostat [2][3] Key Clinical Data - **Clinical Trials**: Successful outcomes from pivotal studies LAUNCH HTN and ADVANCE HTN, with significant blood pressure reductions observed [1][2] - **Efficacy**: Lorundrostat demonstrated a 15-19 mmHg reduction in blood pressure compared to the typical 5 mmHg improvement seen with existing treatments [5][6] - **Patient Demographics**: Strong representation of Black or African American patients in trials, addressing a high-risk population for hypertension [9][10] Drug Profile - **Selectivity**: Lorundrostat shows a selectivity ratio of 374:1 for aldosterone over cortisol, compared to Baxdrostat's 101:1, indicating a better safety profile [11][12] - **Half-Life**: Lorundrostat has a half-life of 10-12 hours, aligning with the diurnal pattern of aldosterone secretion, which may enhance safety [12][13] - **Safety Signals**: Lower incidence of hyperkalemia compared to Baxdrostat, with 8% incidence above 5.5 mEq/L for lorundrostat versus 11% for Baxdrostat [15][16] Market Strategy - **Target Population**: Initial focus on resistant hypertension, with plans to expand into uncontrolled hypertension as prescriber comfort increases [27][30] - **Commercialization Approach**: Open to partnerships but emphasizes the importance of selecting the right partner to maximize the drug's potential [45][46] - **Market Size**: Targeting a broad market of 120 million people with hypertension, with a focus on the top 60,000 prescribers [46][47] Future Developments - **NDA Filing**: Anticipated NDA filing by the end of 2025, with ongoing collection of safety and efficacy data beyond the initial 12-week trials [37][38] - **Additional Studies**: Ongoing studies in chronic kidney disease (CKD) and obstructive sleep apnea (OSA) to explore additional benefits and potential label expansions [42][43] Conclusion - **Investment Potential**: Mineralys Therapeutics is positioned with a best-in-class molecule in a growing market, with strong clinical data supporting its efficacy and safety, making it a compelling investment opportunity in the pharmaceutical sector [19][50]

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.

Core Insights - Mineralys Therapeutics is preparing for the submission of a New Drug Application (NDA) for lorundrostat, anticipated by late 2025 or early 2026, following positive pre-NDA feedback from the FDA [2][3] - The company has completed enrollment in the Explore-OSA trial, with topline results expected in Q1 2026, which will evaluate lorundrostat's efficacy in patients with obstructive sleep apnea and hypertension [1][2] Financial Highlights - As of September 30, 2025, the company reported cash, cash equivalents, and investments totaling $593.6 million, a significant increase from $198.2 million at the end of 2024, indicating a strengthened balance sheet [4][25] - Research and Development (R&D) expenses for Q3 2025 were $31.5 million, down from $54.0 million in Q3 2024, primarily due to the conclusion of the lorundrostat pivotal program [5] - General and Administrative (G&A) expenses rose to $9.7 million in Q3 2025 from $6.1 million in Q3 2024, driven by increased compensation and professional fees [6] - The net loss for Q3 2025 was $36.9 million, a decrease from $56.3 million in Q3 2024, reflecting improved expense management [8][23] Clinical Development - Lorundrostat is being developed as a treatment for uncontrolled and resistant hypertension, chronic kidney disease, and obstructive sleep apnea, with a focus on normalizing aldosterone production [2][17] - The company has completed four successful clinical trials for lorundrostat, demonstrating its efficacy and safety profile [18] Market Context - Hypertension affects a significant portion of the population, with less than 50% of patients achieving their blood pressure goals with current medications, highlighting the need for new treatments like lorundrostat [10][11] - Chronic Kidney Disease (CKD) affects over 10% of the global population, and its relationship with hypertension presents a substantial market opportunity for effective therapies [12][13]

Core Insights - Mineralys Therapeutics presented clinical data for lorundrostat at ASN Kidney Week 2025, highlighting its potential in treating hypertension and chronic kidney disease (CKD) [1][2] - The Explore-CKD trial demonstrated significant reductions in blood pressure and albuminuria, supporting the drug's efficacy [2][4] - The Launch-HTN trial was recognized in the "Best of JAMA and NEJM" session, showcasing lorundrostat's robust performance in managing resistant hypertension [2][4] Clinical Trial Results - The Explore-CKD trial (NCT06150924) showed a 9.3 mmHg reduction in automated office systolic blood pressure (AOSBP) and a 25.6% reduction in urinary albumin-to-creatinine ratio (UACR) after four weeks of treatment with lorundrostat [2][7] - The Launch-HTN trial reported a 16.9 mmHg absolute reduction in systolic blood pressure at week 6 and a 19 mmHg reduction at week 12, with significant placebo-adjusted results [4][10] Safety and Tolerability - Lorundrostat exhibited a favorable safety profile, with serious adverse events occurring in only 3% of participants during treatment, compared to none in the placebo group [3][5] - Discontinuations due to treatment-emergent adverse events were low, indicating good tolerability among participants [3] Broader Implications - The results from both trials suggest that lorundrostat could address the growing burden of cardio-renal-metabolic diseases, particularly in high-risk populations [2][5] - The ongoing Transform-HTN study aims to evaluate the long-term safety and efficacy of lorundrostat, further supporting its clinical potential [5][6] Company Overview - Mineralys Therapeutics is focused on developing therapies targeting hypertension and related comorbidities, with lorundrostat as its lead candidate [1][16] - The company aims to file a New Drug Application (NDA) with the FDA by late 2025 or early 2026, based on the promising results from its clinical trials [2][15]

Core Viewpoint - Mineralys Therapeutics, Inc. is set to report its third-quarter financial results on November 10, 2025, focusing on its development of medicines targeting hypertension and related comorbidities [1] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company based in Radnor, Pennsylvania, specializing in treatments for hypertension and related conditions such as chronic kidney disease (CKD) and obstructive sleep apnea (OSA) [3] - The company's lead product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor [3] - Mineralys was founded by Catalys Pacific and aims to address diseases driven by dysregulated aldosterone [3] Upcoming Financial Results - The financial results for the third quarter ended September 30, 2025, will be announced after market close on November 10, 2025 [1] - A conference call will be held on the same day at 4:30 p.m. ET, with details provided for both domestic and international participants [2]

Core Insights - Mineralys Therapeutics, Inc. is focused on developing treatments for hypertension and related comorbidities, with a key product candidate, lorundrostat, being evaluated in clinical trials [1][4] Group 1: Clinical Trials and Presentations - Data from the Phase 2 Explore-CKD trial of lorundrostat will be presented at the ASN Kidney Week 2025, highlighting its safety and efficacy in participants with hypertension and comorbid CKD [1][6] - The Phase 3 Launch-HTN trial data of lorundrostat will also be featured in a prominent session at ASN Kidney Week, showcasing its relevance in treating uncontrolled hypertension [2][6] Group 2: Product Information - Lorundrostat is a proprietary, orally administered aldosterone synthase inhibitor designed to treat uncontrolled hypertension, chronic kidney disease, and obstructive sleep apnea [3][4] - It exhibits a 374-fold selectivity for aldosterone-synthase inhibition compared to cortisol-synthase inhibition and has shown a 40-70% reduction in plasma aldosterone concentration in hypertensive participants [3]

Summary of Mineralys Therapeutics Conference Call Company Overview - **Company**: Mineralys Therapeutics (NasdaqGS:MLYS) - **Product**: Lorundrostat, an aldosterone synthase inhibitor targeting hypertension, particularly in patients with hyperaldosteronism-driven, uncontrolled, and resistant hypertension Key Points and Arguments 1. **Clinical Success**: Mineralys has achieved successful clinical outcomes in its pivotal program for lorundrostat, with an upcoming FDA filing and preparations for commercial launch expected soon [1][3] 2. **Target Population**: Approximately 30% of hypertension patients exhibit elevated or dysregulated aldosterone, confirming the need for aldosterone-targeted treatments [4] 3. **Market Approach**: The initial market strategy is to target fourth-line treatment for resistant hypertension, with plans to expand into third-line treatment over time [6][9] 4. **Guideline Inclusion**: The company is working closely with key opinion leaders to include lorundrostat in treatment guidelines, which is expected to be achievable based on rigorous trial data [7][8] 5. **Patient Population**: There are about 10 million potential patients with resistant hypertension in the U.S., with an additional 10 million in the third-line category [9][10] 6. **Safety and Efficacy Data**: The company does not anticipate additional incidences of hyperkalemia over time and plans to share comprehensive data with the FDA during the NDA submission [10][11] 7. **Competitive Landscape**: Recent phase three data on Baqsrostat showed comparable results to lorundrostat, but lorundrostat's profile is viewed favorably due to its efficacy and specificity [12][13] 8. **Partnership Opportunities**: Mineralys is open to partnerships to maximize the commercial potential of lorundrostat, especially given the focused nature of the prescribing physician base [18][19] 9. **Independent Launch Considerations**: While an independent launch is feasible, the company believes partnering would enhance market access and efficiency [20][21] 10. **Additional Indications**: Ongoing trials for chronic kidney disease (CKD) and obstructive sleep apnea (OSA) are aimed at establishing a broader treatment profile for lorundrostat [22][24] 11. **Future Development**: Heart failure is identified as a potential area for future research with aldosterone synthase inhibitors [25] 12. **Impact of Weight Loss Treatments**: The rise of GLP-1s and other weight loss treatments may affect the hypertension market, but there remains a significant opportunity for lorundrostat due to the prevalence of elevated aldosterone [26] Additional Important Insights - The company is focused on ensuring that lorundrostat is recognized as a viable treatment option for patients with comorbidities such as CKD and OSA [22][24] - The competitive landscape is evolving, and the company is prepared to address potential counter-detailing from competitors regarding treatment profiles [17] - The overall market for hypertension treatments remains robust, with a significant number of patients requiring effective management strategies [26]

Core Insights - Mineralys Therapeutics has completed enrollment in its Phase 2 EXPLORE-OSA trial for lorundrostat, targeting patients with moderate-to-severe obstructive sleep apnea (OSA) and hypertension, with top-line results expected in Q1 2026 [1][2] - The trial aims to address the significant unmet need for effective treatments for patients suffering from OSA and hypertension, as current options are limited and often ineffective [2][3] - Lorundrostat is a selective aldosterone synthase inhibitor designed to reduce aldosterone levels, which are linked to hypertension and related comorbidities [8][9] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease (CKD), and OSA, driven by dysregulated aldosterone [9] - The company is based in Radnor, Pennsylvania, and was founded by Catalys Pacific [9] Trial Details - The EXPLORE-OSA trial is a randomized, Phase 2 double-blind, placebo-controlled, crossover study evaluating the efficacy, safety, and tolerability of lorundrostat in overweight or obese adults with moderate-to-severe OSA and hypertension [3] - Participants will receive 50 mg of lorundrostat or placebo, with the primary efficacy endpoint being the change in apnea-hypopnea index (AHI) after four weeks of treatment [3] Disease Context - OSA affects nearly one billion people globally, with 425 million cases classified as moderate-to-severe, and around 80% of adults with OSA remain undiagnosed [4] - Hypertension is a major health issue, contributing to over 685,000 deaths in the U.S. in 2022, with an estimated economic burden of $219 billion in 2019 [6] Market Opportunity - Between 30-50% of adults with hypertension have OSA, and this figure rises to 70-80% in those with resistant hypertension (rHTN) [5] - There is a significant opportunity for lorundrostat to address the needs of patients with both hypertension and OSA, particularly given the limitations of current treatment options [2][5]

Core Viewpoint - The healthcare sector is experiencing significant stock price increases, with some stocks more than doubling in value since the end of July, indicating potential for further gains despite recent surges [1][2]. Group 1: Precigen - Precigen's shares increased by 155% from the end of July to September 5, following FDA approval for its first treatment, Papzimeos, which is aimed at recurrent respiratory papillomatosis (RRP) [4][5]. - Papzimeos is the first and only FDA-approved treatment for approximately 27,000 patients with RRP, with a notable response rate in clinical trials where 18 out of 35 patients avoided surgery for at least 12 months post-treatment [5][6]. - Analysts, including Swayampakula Ramakanth from HC Wainwright, have set a price target of $8.50 for Precigen, suggesting a potential 95% increase in the next year [6]. Group 2: Mineralys Therapeutics - Mineralys Therapeutics saw a 146% rise in stock price from the end of July to September 5, driven by a successful funding round for the development of its lead candidate, lorundrostat [7][8]. - The company raised $287.5 million through a secondary offering, which followed the suspension of an at-the-money equity offering [8]. - In a phase 3 trial, lorundrostat demonstrated a significant reduction in systolic pressure, outperforming a placebo [9]. - Following AstraZeneca's less favorable data for a competing product, Bank of America analyst Greg Harrison raised the target price for Mineralys to $43 per share, indicating a potential 24% gain [11]. - Despite the positive outlook, the company ended June with $325 million in cash, sufficient to last until 2027, raising concerns about the urgency of submitting for approval [12]. - Mineralys has a market cap of $2.7 billion, which could be affected by the timing of lorundrostat's approval compared to competitors [14]. Group 3: Market Potential - Precigen's market cap is approximately $1.3 billion, with expectations for Papzimeos potentially underestimated, as it is set to launch in a niche market without competition [15]. - Papzimeos could generate over $1 billion in annual sales at peak pricing, with a list price exceeding $200,000 per patient per year [16].

Core Insights - The Launch-HTN trial of lorundrostat, a novel aldosterone synthase inhibitor, shows significant blood pressure reductions in diverse high-risk patient populations with uncontrolled hypertension [1][2][3] - The trial enrolled 1,083 participants, making it the largest global Phase 3 trial for uncontrolled or resistant hypertension [6][12] - Lorundrostat demonstrated a favorable safety and tolerability profile, with no new safety signals observed [5][8] Company Overview - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension and related conditions driven by dysregulated aldosterone [1][15] - The company plans to file a New Drug Application (NDA) for lorundrostat in late 2025 or early 2026 [9] Trial Details - The Launch-HTN trial utilized automated office blood pressure measurements and allowed participants to continue existing antihypertensive medications [6][12] - Key demographics of the trial included 29% Black/African American participants, 41% aged 65 or older, and 63% with obesity [2][3] Efficacy Results - Lorundrostat 50 mg showed statistically significant reductions in blood pressure across various subgroups, including a 16.9 mmHg reduction at Week 6 and a 19.0 mmHg reduction at Week 12 [7][12] - The trial results indicated consistent blood pressure lowering effects across high-risk subgroups, addressing a critical unmet medical need [3][4] Safety Profile - The safety outcomes were favorable, with adverse events generally mild or moderate, and a very low incidence of serious drug-related adverse events [5][8] - No significant suppression of cortisol production was observed, and electrolyte changes were modest and reversible [8] Market Context - Hypertension is a leading modifiable risk factor for cardiovascular disease, contributing to over 685,000 deaths in the U.S. in 2022 [10] - Less than 50% of hypertension patients achieve their blood pressure goals with current medications, highlighting the need for new treatments like lorundrostat [11]