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]

Core Insights - Mineralys Therapeutics is focused on developing lorundrostat, a treatment for hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA) [2][18] - The company anticipates significant clinical data releases in 2025, including topline data from pivotal trials for lorundrostat [1][5] Clinical Development - The pivotal Advance-HTN trial is expected to report topline data in March 2025, evaluating lorundrostat for uncontrolled or resistant hypertension [5] - The Launch-HTN Phase 3 trial is set to report topline data in the first half of 2025, focusing on patients who do not achieve blood pressure control with existing medications [5] - Enrollment for the Explore-CKD Phase 2 trial has been completed, with topline data anticipated in Q2 2025 [1][5] - A new Phase 2 trial for lorundrostat in patients with moderate-to-severe OSA and hypertension is planned to initiate in Q1 2025 [1][5] Financial Performance - As of December 31, 2024, the company reported cash, cash equivalents, and investments totaling $198.2 million, down from $239.0 million in 2023 [4] - Research and Development (R&D) expenses for 2024 were $168.6 million, significantly higher than $70.4 million in 2023, primarily due to increased clinical costs [5][6] - General and Administrative (G&A) expenses rose to $23.8 million in 2024 from $14.3 million in 2023, driven by higher compensation and professional fees [7] - The net loss for 2024 was $177.8 million, compared to $71.9 million in 2023, reflecting increased operational expenses [9][22] Market Context - Hypertension affects a significant portion of the population, with less than 50% of patients achieving their blood pressure goals with current medications [12] - Dysregulated aldosterone levels contribute to hypertension in approximately 25% of hypertensive patients, indicating a potential market for aldosterone-targeting therapies like lorundrostat [12][16] - CKD affects over 10% of the global population, with diabetes and hypertension being major contributors [13] - OSA impacts nearly one billion people globally, with a significant overlap with hypertension, particularly in resistant cases [15]

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] Financial Results Announcement - The company will report its financial results for the fourth quarter and full year ended December 31, 2024, before the markets open on February 12, 2025 [1] Conference Call Details - A live conference call will take place on February 12 at 8:30 a.m. ET, with domestic and international dial-in numbers provided [2] Company Overview - Mineralys Therapeutics is developing lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor aimed at treating cardiorenal conditions influenced by dysregulated aldosterone [3]

Continues to anticipate announcing topline data from Explore-CKD trial in Q2 2025RADNOR, Pa., Feb. 04, 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 (OSA) and other diseases driven by dysregulated aldosterone, today announced that it has completed enrollment in the Explore-CKD Phase 2 trial evaluating the efficacy and safety of lorun ...

– Estimated 54 million people suffer from obstructive sleep apnea in the U.S. including 30-50% of adults with hypertension, both conditions associated with excess morbidity and mortality – – Obstructive sleep apnea represents Mineralys’ third precision, targeted indication for lorundrostat, further expanding its market potential in aldosterone-driven diseases – – Initiation of the trial anticipated in the first quarter of 2025 – RADNOR, Pa., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Na ...

RADNOR, Pa., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by dysregulated aldosterone, today announced it will report its financial results from the third quarter ended September 30, 2024, after the financial markets close on Monday, November 11, 2024. Monday, November 11th @ 4:30 p.m. ET Domestic:1-877-407-9127Internation ...

I covered Mineralys (NASDAQ: MLYS ) in April last year. It had a few things going that got me interested: It was a new IPO, had just published positive phase 2 data, and it had a strong board of directors. The stock took a deep About the TPT service Thanks for reading. At the Total Pharma Tracker, we offer the following :- ing Balance (millior Projected American Shared Revenue Backlog $250 $213 $200 $150 $106 $104 $101 $100 $50 $0 12/31/21 12/31/22 12/31/23 5/10/24 (projected*) Ending Balance Date *This cha ...

LOS ANGELES, Sept. 09, 2024 (GLOBE NEWSWIRE) -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Mineralys Therapeutics, Inc. ("Mineralys" or "the Company") (NASDAQ: MLYS) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Mineralys released its second quarter 2024 financial results ...