RADNOR, Pa., March 17, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea and other diseases driven by dysregulated aldosterone, today announced that data from the Phase 2 Advance-HTN trial evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) will be pres ...

Core Viewpoint - Mineralys Therapeutics, Inc. has announced a public offering of 12,962,962 shares at a price of $13.50 per share, aiming to raise approximately $175.0 million before expenses [1][3]. Group 1: Offering Details - The public offering is expected to close on or about March 13, 2025, pending customary closing conditions [1]. - The underwriters have a 30-day option to purchase an additional 1,944,444 shares [1]. - The offering is being managed by BofA Securities, Evercore ISI, Goldman Sachs & Co. LLC, Stifel, and Wells Fargo Securities as joint book-running managers [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to fund 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: Company Overview - Mineralys Therapeutics 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 [6]. - The company's lead product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor targeting cardiorenal conditions [6].

Group 1 - The article discusses Mineralys Therapeutics (NASDAQ: MLYS) and its upcoming hypertension data readout expected in the second half of 2024 [2] - The author runs a pharmaceutical service called Biotech Analysis Central, which provides in-depth analysis of various pharmaceutical companies [2] - The service includes a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [2] Group 2 - The article does not contain any specific financial data or performance metrics related to Mineralys Therapeutics or the broader industry [1][3][4]

Core Viewpoint - Mineralys Therapeutics, Inc. has announced a public offering of $250 million in common stock to fund clinical development and other corporate purposes [1][3]. Group 1: Offering Details - The company is commencing an underwritten public offering of $250 million, with an option for underwriters to purchase an additional $37.5 million [1]. - The offering is subject to market conditions and there is no assurance regarding its completion or terms [1]. - Joint book-running managers for the offering include BofA Securities, Evercore ISI, Goldman Sachs & Co. LLC, Stifel, and Wells Fargo Securities [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to fund clinical development of lorundrostat, including research, development, manufacturing, and pre-commercialization activities [3]. - Additional funds will be allocated for working capital and general corporate purposes [3]. Group 3: Company Overview - Mineralys Therapeutics 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 [6]. - The company's lead product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor [6].

Core Insights - Mineralys Therapeutics, Inc. released positive topline data from its pivotal Launch-HTN Phase 3 and Advance-HTN Phase 2 trials for lorundrostat, indicating significant efficacy in treating uncontrolled and resistant hypertension [1] Group 1: Trial Results - The Launch-HTN trial achieved its primary endpoint, with a 50 mg dose of lorundrostat resulting in a 16.9 mmHg reduction in systolic blood pressure and a 9.1 mmHg placebo-adjusted reduction at week 6 [2] - An alternative report from the Launch-HTN trial indicated a 19.0 mmHg reduction in systolic blood pressure and an 11.7 mmHg placebo-adjusted reduction [3] - The Advance-HTN trial also met its primary endpoint, showing a placebo-adjusted reduction of 7.9 mmHg in systolic blood pressure at week 12 [4] Group 2: Safety Profile - Clinical safety findings from both pivotal trials indicated a favorable benefit-risk profile, with assessments of hypotension, serum potassium, eGFR, and serum cortisol [4] Group 3: Future Developments - In February, the company completed enrollment in the Explore-CKD Phase 2 trial, which evaluates lorundrostat's efficacy and safety for hypertension in subjects with chronic kidney disease and albuminuria [5] - The FDA cleared an Investigational New Drug (IND) application for a Phase 2 trial of lorundrostat targeting moderate-to-severe obstructive sleep apnea and hypertension, with the trial expected to start in Q1 2025 [6] Group 4: Market Reaction - Following the positive trial results, MLYS stock increased by 65.70%, reaching $17.43 [6]

Core Insights - Mineralys Therapeutics announced positive topline data from its pivotal Launch-HTN Phase 3 and Advance-HTN Phase 2 trials for lorundrostat, demonstrating significant efficacy and safety in treating uncontrolled and resistant hypertension [2][3] Efficacy Results - The Launch-HTN trial achieved a 16.9 mmHg reduction in systolic blood pressure at week 6 and a 19.0 mmHg reduction at week 12, with placebo-adjusted reductions of 9.1 mmHg and 11.7 mmHg respectively (p-value < 0.0001) [1][5] - The Advance-HTN trial reported a 7.9 mmHg placebo-adjusted reduction in systolic blood pressure at week 12 [1][6] - Both trials demonstrated clinically meaningful and statistically significant results, supporting the potential of lorundrostat as a new treatment option for approximately 15 to 20 million patients with uncontrolled hypertension in the U.S. [3][4] Safety and Tolerability - Lorundrostat exhibited a favorable safety and tolerability profile across both pivotal trials, with low incidences of serious adverse events and manageable side effects [8][14] - The incidence of hyperkalemia was reported at 1.1% and 1.5% in the Launch-HTN trial and 5.3% and 7.4% in the Advance-HTN trial [14] Future Developments - Full results from the Advance-HTN trial are scheduled to be presented on March 29, 2025, at the American College of Cardiology Scientific Sessions [1][7] - The ongoing Transform-HTN open-label extension trial will continue to gather safety and efficacy data for lorundrostat [10] Company Overview - Mineralys Therapeutics is focused on developing treatments for hypertension, chronic kidney disease, and obstructive sleep apnea, with lorundrostat being its lead candidate [2][19] - The company aims to address the significant unmet medical need in hypertension, where less than 50% of patients achieve their blood pressure goals with current medications [12][13]

Core Insights - Mineralys Therapeutics, Inc. is set to announce topline results from its pivotal trials, Launch-HTN and Advance-HTN, on March 10, 2025 [1] Group 1: Company Overview - Mineralys Therapeutics 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 [5] - The company's lead product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor [5] Group 2: Trial Details - The Launch-HTN trial assessed the efficacy and safety of lorundrostat as an add-on therapy for uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) in patients already on two to five antihypertensive medications [2] - The Advance-HTN trial evaluated lorundrostat's efficacy and safety when used as an add-on therapy for uHTN or rHTN with a standardized background treatment of two or three antihypertensive medications [3]

Financial Data and Key Metrics Changes - The company ended Q4 2024 with cash, cash equivalents, and investments of $198.2 million, down from $239 million as of December 31, 2023, indicating a decrease in liquidity [25] - R&D expenses for the year were $168.6 million, significantly up from $70.4 million in 2023, with Q4 R&D expenses at $44.6 million compared to $23.7 million in Q4 2023 [26] - Net loss for the year was $177.8 million, compared to $71.9 million in 2023, with Q4 net loss at $48.9 million versus $24.4 million in Q4 2023 [29] Business Line Data and Key Metrics Changes - The company is focused on clinical programs targeting dysregulated aldosterone in patients with uncontrolled and resistant hypertension, with pivotal trials Advance-HTN and Launch-HTN ongoing [10][11] - The Advance-HTN trial enrolled 285 subjects, while the Launch-HTN trial has 1,083 subjects, both designed to evaluate the efficacy and safety of lorundrostat [11][12] Market Data and Key Metrics Changes - The company anticipates announcing top-line data for the Advance-HTN trial in March 2025 and for the Launch-HTN trial in the mid-first half of 2025 [9][50] - The resistant hypertension population is estimated to be about 10% to 15% of the treated population, translating to approximately 7.5 million to 10 million subjects [74] Company Strategy and Development Direction - The company aims to create healthier days for patients with cardiorenal metabolic disorders, focusing on the unmet medical need in uncontrolled and resistant hypertension [10] - The strategic focus includes the development of lorundrostat as a new therapy that could change the current treatment paradigm for hypertension [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts and the potential of lorundrostat to demonstrate meaningful benefits in patients with uncontrolled or resistant hypertension [16] - The company remains enthusiastic about the progress made in 2024 and the upcoming data milestones planned for the first half of 2025 [117] Other Important Information - The company completed enrollment in the Explore-CKD Phase II trial, which evaluates lorundrostat's efficacy in patients with chronic kidney disease [18] - The Explore-OSA Phase II trial is set to evaluate lorundrostat's effect on moderate-to-severe obstructive sleep apnea [20] Q&A Session Summary Question: Confidence in SBP reduction extrapolation from Phase II trial - Management expressed confidence in the 50 mg QD dose based on totality of evidence and previous trial data [34][36] Question: Mechanism of improvement in OSA trial - Management indicated that both fluid volume reduction and non-genomic effects may contribute to improvements in the apnea-hypopnea index [40][42] Question: Guidance on Advance and Launch readout timelines - Management confirmed that Advance-HTN results are expected in March, while Launch-HTN results are anticipated in the mid-first half of 2025 [49] Question: Compliance expectations for ABPM device - Management assured that training and experience with the device would ensure high compliance and quality data collection [54][56] Question: Threshold for hyperkalemia rates in trials - Management indicated that a hyperkalemia rate of 5% or less is viewed favorably, with expectations that diuretics may offset potassium increases [78][82] Question: Differences in treatment effect between pivotal studies - Management noted that while Advance may be more rigorous, it could also be enriched for aldosterone-driven hypertension, making direct comparisons challenging [101][102]

Financial Performance and Losses - The company has incurred significant operating losses of $177.8 million and $71.9 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $302.5 million as of December 31, 2024[163]. - The company expects to continue incurring significant losses for the foreseeable future as it develops lorundrostat and seeks regulatory approval, anticipating these losses will increase substantially[163][165]. - The company believes its existing cash and investments will fund operations for at least the next 12 months, but this estimate is based on assumptions that may prove incorrect[167]. - The company may face challenges in raising additional capital due to worsening global economic conditions and market volatility[167]. - The company may face significant fluctuations in operating results, making future performance difficult to predict[253]. Product Development and Regulatory Approval - The company has not generated any revenue since its inception and does not have any products approved for sale, relying entirely on the successful development and commercialization of its product candidate, lorundrostat[163][172]. - The development of lorundrostat requires substantial additional capital, and the company may need to raise funds through equity offerings, debt financings, or collaborations[166][170]. - The company must successfully complete clinical trials and obtain regulatory approvals to achieve profitability, which remains uncertain[164][165]. - The company faces numerous risks in clinical trials, including the potential for unfavorable results and delays in obtaining regulatory approvals[175]. - The company must conduct extensive clinical trials to demonstrate the safety and efficacy of lorundrostat before obtaining marketing approval from regulatory authorities[179]. - Regulatory authorities may require additional preclinical studies or clinical trials, leading to increased costs and delays in product development[179]. - The company must establish a safety database satisfactory to regulatory authorities to demonstrate the safety and efficacy of lorundrostat[176]. - Clinical trials must comply with FDA and other regulatory requirements, and any deviations could result in delays or termination of trials[183]. - The company may face challenges in conducting clinical trials in foreign countries due to cultural differences and regulatory complexities[184]. - The company must maintain relationships with third-party manufacturers to ensure compliance with cGMPs and support commercialization[176]. Clinical Trial Risks and Challenges - The Target-HTN Phase 2 clinical trial of lorundrostat involved 200 patients, indicating a small sample size relative to ongoing or future trials[177]. - Difficulties or delays in clinical trials could result in increased costs and limit the ability to generate revenue, adversely affecting commercial prospects[179]. - The company faces challenges in patient enrollment for clinical trials, which could delay or adversely affect clinical development activities[188]. - Adverse side effects associated with lorundrostat could delay or preclude regulatory approval, impacting the company's business and financial condition[191]. - There is a risk that larger clinical trials may reveal more adverse events than previously observed, which could significantly harm the company's business and financial condition[194]. - If lorundrostat receives marketing approval but later undesirable side effects are identified, it could lead to regulatory actions such as product recalls or additional warnings, negatively impacting market acceptance[195]. Manufacturing and Supply Chain Risks - The company does not own manufacturing facilities and relies on third parties for the manufacture of lorundrostat, increasing risks related to supply and compliance with regulatory requirements[215]. - The company has no long-term supply agreements with third-party manufacturers, raising the risk of insufficient quantities of lorundrostat at acceptable costs[217]. - The reliance on third parties for manufacturing may adversely affect future profit margins and the ability to commercialize products on a timely basis[220]. - Changes in manufacturing methods during product development may lead to increased costs or delays, jeopardizing the ability to commercialize lorundrostat[205]. - The company relies heavily on the Mitsubishi License for lorundrostat, and termination of this license would result in a loss of rights to develop and commercialize the product, adversely affecting financial condition[208]. Intellectual Property and Legal Risks - The company relies on a combination of patents, trademarks, and in-licenses to protect its intellectual property related to lorundrostat and future product candidates[302]. - The patent prosecution process is expensive and complex, and the company may not be able to maintain or enforce all necessary patent applications[305]. - The company faces risks related to the validity and enforceability of its patent rights, which could allow competitors to commercialize similar products[307]. - Legal proceedings to enforce intellectual property rights could incur substantial costs and divert resources from core business activities, potentially leading to invalidation of patents[314]. - The company may face significant harm if it fails to obtain patent term extensions for its product candidates, which could be limited to a maximum of 5 years under the Hatch-Waxman Amendments[329]. Market and Competitive Landscape - The commercial success of lorundrostat will depend on market acceptance by healthcare providers and payors, which is uncertain[233]. - Coverage and adequate reimbursement from third-party payors are essential for the successful commercialization of lorundrostat[236]. - The company faces significant competition from larger pharmaceutical firms and research institutions, which may hinder its market position[245]. - Third-party payors are increasingly challenging prices for biopharmaceutical products, which could limit revenue generation[239]. - The total addressable market for lorundrostat will depend on various factors, including diagnosis criteria, alternative treatments, and patient access[250]. Compliance and Regulatory Environment - The company is subject to various healthcare laws and regulations that could increase compliance costs and impact financial condition[261]. - The FDA and other regulatory agencies strictly regulate promotional claims, and violations could lead to significant liabilities[231]. - Legislative changes may increase the difficulty and cost for the company to obtain marketing approval for lorundrostat and future product candidates[264]. - The company may incur significant penalties if it fails to report adverse medical events related to its products[275]. - The company is facing heightened governmental scrutiny regarding pharmaceutical pricing practices, which could affect its business operations[268]. Cybersecurity and Data Protection - The company is increasingly dependent on information technology systems, which are vulnerable to security breaches and could disrupt product development programs[286]. - Cybersecurity threats are rising in frequency and sophistication, posing risks to the company's operations and data[287]. - Any security breach could significantly impact the company's reputation, operations, and customer confidence, potentially leading to increased costs[288]. - The company has experienced past security incidents and may face future incidents that could disrupt operations and result in unauthorized access to sensitive information[289]. - Third-party vendors may have access to the company's confidential information, and their security failures could lead to significant liabilities[291].

Financial Performance - Cash, cash equivalents, and investments were $198.2 million as of December 31, 2024, down from $239.0 million as of December 31, 2023[6] - Net loss for the year ended December 31, 2024, was $177.8 million, compared to a net loss of $71.9 million for the year ended December 31, 2023[11] - Total other income, net for the year ended December 31, 2024, was $14.6 million, an increase from $12.8 million in 2023[9] - Total assets decreased to $205.903 million from $251.636 million, representing a decrease of about 18.1% year-over-year[27] - Total liabilities increased to $14.646 million from $10.482 million, an increase of approximately 39.9% year-over-year[27] - Total stockholders' equity decreased to $191.257 million from $241.154 million, a decline of about 20.7% year-over-year[27] Expenses - Research and Development (R&D) expenses for the year ended December 31, 2024, were $168.6 million, a significant increase from $70.4 million in 2023[7] - General and Administrative (G&A) expenses rose to $23.8 million for the year ended December 31, 2024, compared to $14.3 million for 2023[8] Clinical Trials and Studies - Anticipated topline data from the pivotal Advance-HTN trial in March 2025 and the Launch-HTN trial in mid-2025[1] - Enrollment in the Explore-CKD Phase 2 trial has been completed, with topline data expected in Q2 2025[1] - Initiation of the Phase 2 trial for lorundrostat in patients with moderate-to-severe obstructive sleep apnea and hypertension is planned for Q1 2025[1] - Lorundrostat demonstrated approximately a 70% reduction in plasma aldosterone concentration in hypertensive subjects[19] Cash Flow and Funding - The company believes its current cash and investments will fund planned clinical studies through the first quarter of 2026[6] - Cash, cash equivalents, and investments decreased to $198.187 million from $239.049 million, a decline of approximately 17.1% year-over-year[27]