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Mineralys Therapeutics (NasdaqGS:MLYS) Conference Transcript
2025-09-30 18:32
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]
Mineralys Therapeutics Completes Enrollment in Phase 2 EXPLORE-OSA Trial of Lorundrostat in Obstructive Sleep Apnea and Hypertension
Globenewswire· 2025-09-30 12:00
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]
These 2 Healthcare Stocks More Than Doubled Recently and Could Soar Higher, According to Wall Street Analysts
The Motley Fool· 2025-09-07 12:23
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].
Mineralys Therapeutics Presents Subgroup Analyses of Phase 3 Launch-HTN Trial Demonstrating Efficacy and Safety of Lorundrostat in Hypertension Participants with High Unmet Medical Need
Globenewswire· 2025-09-05 13:00
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]
Mineralys Therapeutics Presents Subgroup Analyses of Phase 3 Launch-HTN Trial Demonstrating Efficacy and Safety of Lorundrostat in Hypertension Participants with High Unmet Medical Need
Newsfilter· 2025-09-05 13:00
Core Insights - The Launch-HTN trial of lorundrostat, a novel aldosterone synthase inhibitor, shows significant blood pressure reductions in diverse high-risk 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 [7] - Lorundrostat demonstrated a favorable safety and tolerability profile, with no new safety signals observed [6][9] 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 [10] Trial Details - The Launch-HTN trial utilized automated office blood pressure measurements and allowed participants to continue existing antihypertensive medications [7][12] - Key demographics included 29% Black/African American, 41% aged 65 or older, and 63% with obesity [2][3] Efficacy Results - Lorundrostat 50 mg showed consistent, statistically significant reductions in blood pressure across various subgroups, including a 16.9 mmHg reduction at Week 6 [8][4] - The trial results indicated that lorundrostat could address critical unmet medical needs in high-risk patient cohorts [3][4] Safety Profile - The safety outcomes were favorable, with adverse events generally mild or moderate, and no significant new safety concerns identified [6][9] - The incidence of serious adverse events leading to discontinuation was very low [9] Future Directions - Mineralys is moving forward with its NDA filing strategy and has scheduled a pre-NDA meeting with the FDA [10] - The company aims to evaluate lorundrostat for potential treatment of chronic kidney disease and obstructive sleep apnea in addition to hypertension [13][15]
Mineralys Therapeutics Announces Closing of Upsized $287.5 Million Underwritten Public Offering of Common Stock Including Full Exercise of Underwriters’ Option to Purchase Additional Shares
GlobeNewswire· 2025-09-04 20:01
Core Viewpoint - Mineralys Therapeutics, Inc. has successfully closed a public offering of 11,274,509 shares of common stock, raising approximately $287.5 million before expenses, to fund the development of its product candidate lorundrostat and for general corporate purposes [1][2]. Group 1: Offering Details - The public offering price was set at $25.50 per share, which included the full exercise of the underwriters' option to purchase an additional 1,470,588 shares [1]. - The offering was managed by BofA Securities, Evercore ISI, Goldman Sachs & Co. LLC, Stifel, and Wells Fargo Securities, with LifeSci Capital as the lead manager [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for clinical development of lorundrostat, including research, development, manufacturing, and pre-commercialization activities, as well as for working capital and general corporate purposes [2]. Group 3: Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension and related comorbidities, including chronic kidney disease and obstructive sleep apnea, driven by dysregulated aldosterone [5]. - The company's initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor [5].
Mineralys Therapeutics Announces Pricing of Upsized $250.0 Million Underwritten Public Offering of Common Stock
Globenewswire· 2025-09-03 01:33
Core Viewpoint - Mineralys Therapeutics, Inc. has announced an upsized underwritten public offering of 9,803,921 shares at a price of $25.50 per share, aiming to raise approximately $250 million before expenses [1][3]. Group 1: Offering Details - The public offering consists of 9,803,921 shares priced at $25.50 each, with expected gross proceeds of around $250 million [1]. - Mineralys has granted underwriters a 30-day option to purchase an additional 1,470,588 shares [1]. - The offering is anticipated to close on or about September 4, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for the clinical development of lorundrostat, including research, development, manufacturing, and pre-commercialization activities, as well as for working capital and general corporate purposes [3]. Group 3: Underwriters - BofA Securities, Evercore ISI, Goldman Sachs & Co. LLC, Stifel, and Wells Fargo Securities are serving as joint book-running managers for the offering [2]. - LifeSci Capital is acting as the lead manager, while H.C. Wainwright & Co. is the co-manager for the offering [2]. Group 4: Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension and related comorbidities, including chronic kidney disease and obstructive sleep apnea [6]. - The company's lead product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor [6].
Mineralys Therapeutics(MLYS) - 2025 Q2 - Earnings Call Transcript
2025-08-12 21:30
Financial Data and Key Metrics Changes - The company ended Q2 2025 with cash, cash equivalents, and investments of $324.9 million, up from $198.2 million as of December 31, 2024, indicating a significant increase in liquidity [14] - R&D expenses for Q2 2025 were $38.3 million, a slight decrease from $39.3 million in Q2 2024, primarily due to reduced preclinical and clinical costs [15] - G&A expenses increased to $8.5 million in Q2 2025 from $5.9 million in Q2 2024, driven by higher compensation and professional fees [16] - The net loss for Q2 2025 was $43.3 million, compared to $41.0 million in Q2 2024, reflecting increased expenses [17] Business Line Data and Key Metrics Changes - The company is focused on developing aldosterone synthase inhibitors (ASIs) for hypertension and related conditions, with promising clinical data from trials such as LAUNCH HTN and ADVANCE HTN [6][10] - A survey indicated that 95% of clinicians would likely prescribe lorundrostat if approved, highlighting strong interest in the product [7] Market Data and Key Metrics Changes - Uncontrolled and resistant hypertension affects over 20 million patients in the U.S., representing a significant unmet medical need [8] - The company has identified nearly 9 million patients who started new treatments in the third line or later position in 2024, reflecting dissatisfaction with current options [7] Company Strategy and Development Direction - The company aims to enhance the profile of lorundrostat in treating hypertension with comorbid conditions like chronic kidney disease (CKD) and obstructive sleep apnea (OSA) [10][12] - A pre-NDA meeting with the FDA is scheduled for 2025, indicating progress towards regulatory approval [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data supporting lorundrostat's efficacy and safety, emphasizing the unmet need in the market [21][34] - The company is exploring partnership opportunities, particularly outside the U.S., to maximize the reach of lorundrostat [24] Other Important Information - The company is expanding its medical communications team to raise awareness and interest in lorundrostat ahead of its potential launch [9] - The EXPLORER OSA trial is expected to provide top-line data in 2026, focusing on the effects of lorundrostat on nighttime blood pressure [12] Q&A Session Summary Question: Thoughts on AstraZeneca's Phase III Vax HTN data - Management refrained from speculating on AstraZeneca's data but expressed confidence in lorundrostat's safety and efficacy based on their own trials [21][22] Question: Opportunities for lorundrostat beyond hypertension - Management indicated potential for lorundrostat in treating related comorbidities like CKD and OSA, emphasizing its role in managing dysregulated aldosterone [30] Question: Payer strategies and market access - Management does not anticipate a step edit through spironolactone, expecting payers to navigate access through generic classes instead [55] Question: Commercial strategy and market entry - The company is currently focused on payer strategy and medical affairs to build awareness for lorundrostat, with specific commercial strategies still in development [59][60] Question: Pre-NDA meeting expectations - Management is confident in the comprehensive data package prepared for the FDA, which includes insights from various clinical trials [62] Question: Concerns about drug-drug interactions - Management clarified that PPI use is allowed in trials, and the focus is on ensuring adequate blood pressure control rather than safety concerns [41] Question: Future data releases from ongoing trials - Management confirmed plans to publish data from the open-label extension trial, TRANSFORM HDN, as it becomes available [74]
Mineralys Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-08-12 20:05
Core Insights - Mineralys Therapeutics, Inc. announced positive results from pivotal trials for lorundrostat, a treatment for hypertension and related conditions, and plans to meet with the FDA for a pre-NDA meeting in Q4 2025 [1][3][4] Clinical Developments - The Launch-HTN Phase 3 trial met its primary endpoint, demonstrating efficacy and safety for lorundrostat in uncontrolled or resistant hypertension [4] - The Advance-HTN trial also met its primary endpoints, reinforcing the favorable benefit-risk profile of lorundrostat in high-risk populations [4] - The Explore-CKD Phase 2 trial showed significant reductions in systolic blood pressure (9.25 mmHg) and urine albumin-to-creatinine ratio (30.51%) [4] - Ongoing Explore-OSA Phase 2 trial is expected to report topline results in 1H 2026 [1][4] Financial Performance - As of June 30, 2025, the company reported cash, cash equivalents, and investments of $324.9 million, up from $198.2 million at the end of 2024, sufficient to fund operations into 2027 [5][31] - R&D expenses for Q2 2025 were $38.3 million, a decrease from $39.3 million in Q2 2024, primarily due to the conclusion of the lorundrostat pivotal program [6] - General and Administrative expenses increased to $8.5 million in Q2 2025 from $5.9 million in Q2 2024, driven by higher compensation and professional fees [7] - The net loss for Q2 2025 was $43.3 million, compared to $41.0 million in Q2 2024 [9][29] Market Context - Hypertension affects a significant portion of the population, with less than 50% of patients achieving blood pressure goals with current medications [11][12] - Chronic kidney disease (CKD) affects over 10% of the global population and is closely linked to hypertension, increasing cardiovascular risks [13][15] - Obstructive sleep apnea (OSA) is prevalent among hypertensive patients, with untreated cases contributing to resistant hypertension [17][18] Product Overview - Lorundrostat is a selective aldosterone synthase inhibitor designed to treat uncontrolled and resistant hypertension, CKD, and OSA [19][21] - The drug has shown a 40-70% reduction in plasma aldosterone concentration in hypertensive participants [19][20]
Mineralys Therapeutics to Announce Second Quarter 2025 Financial Results and Host Conference Call on Tuesday, August 12, 2025
Globenewswire· 2025-08-04 20:05
Core Insights - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension and related comorbidities [3] - The company will report its financial results for the second quarter ended June 30, 2025, on August 12, 2025, after market close [1][2] Company Overview - Mineralys Therapeutics specializes in medicines targeting hypertension, hypertensive nephropathy, obstructive sleep apnea, and diseases driven by dysregulated aldosterone [3] - The company's lead product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor [3] - Mineralys is headquartered in Radnor, Pennsylvania, and was founded by Catalys Pacific [3]