Mineralys Therapeutics(MLYS) - 2025 Q2 - Quarterly Results

Corporate Update Mineralys Therapeutics provided Q2 2025 financial results and a corporate update, highlighting positive clinical trial outcomes for lorundrostat and upcoming NDA submission plans Company Overview and CEO Statement Mineralys Therapeutics, a clinical-stage biopharmaceutical company, announced Q2 2025 financial results and a corporate update, with the CEO highlighting positive results from three clinical trials for lorundrostat and a pre-NDA meeting scheduled for 4Q 2025 - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD) and obstructive sleep apnea (OSA), driven by dysregulated aldosterone[2] - CEO Jon Congleton stated that positive results from three clinical trials for lorundrostat in uncontrolled or resistant hypertension support its potential as a leading new therapy to control hypertension and reduce cardiovascular risk[3] - A pre-NDA meeting with the FDA is scheduled for the fourth quarter of 2025, advancing the company's NDA strategy[1][3] Recent Clinical Highlights and Upcoming Milestones Mineralys reported positive results from its pivotal Launch-HTN and Advance-HTN trials, published in JAMA and NEJM, respectively, with the Explore-CKD Phase 2 trial also meeting its primary endpoint, and topline results for the Explore-OSA Phase 2 trial anticipated in 1H 2026 - Pivotal Launch-HTN Phase 3 Trial met its primary endpoint for efficacy and safety in uncontrolled or resistant hypertension as add-on therapy, with results published in JAMA (June 30, 2025) and presented at the 2025 European Society of Hypertension Meeting[4][7] - Pivotal Advance-HTN Trial met its primary endpoints for efficacy and safety in confirmed uHTN or rHTN, reinforcing lorundrostat's favorable benefit-risk profile, with results published in NEJM (April 23, 2025) and presented at ACC.25 meeting[7] Explore-CKD Phase 2 Trial Key Results (Lorundrostat 25 mg) | Metric | Reduction | Placebo-Adjusted Reduction | p-value | | :-------------------------------- | :---------------- | :------------------------- | :------ | | Systolic BP (AOBP) at Week 4 | 9.25 mmHg | 7.5 mmHg | 0.0024 | | Spot UACR from Baseline at Week 4 | 30.51% | 25.6% | 0.0015 | - The Explore-OSA Phase 2 trial, evaluating lorundrostat in overweight/obese participants with moderate-to-severe OSA and uHTN/rHTN, is ongoing, with topline results anticipated in 1H 2026[7] Second Quarter 2025 Financial Highlights Mineralys Therapeutics reported its Q2 2025 financial performance, detailing changes in cash, R&D, G&A expenses, other income, and net loss Cash, Cash Equivalents and Investments Mineralys Therapeutics reported a significant increase in its cash, cash equivalents, and investments, reaching $324.9 million as of June 30, 2025, up from $198.2 million at the end of 2024, with these funds believed to be sufficient to support operations into 2027 Cash, Cash Equivalents and Investments (in millions) | Metric | As of June 30, 2025 | As of December 31, 2024 | Change | | :-------------------------------- | :------------------ | :---------------------- | :----- | | Cash, cash equivalents and investments | $324.9 million | $198.2 million | +$126.7 million | - The Company believes its current cash, cash equivalents, and investments will be sufficient to fund planned clinical trials, regulatory activities, and corporate operations into 2027[5] Research and Development (R&D) Expenses R&D expenses for Q2 2025 decreased slightly to $38.3 million from $39.3 million in Q2 2024, primarily due to the conclusion of the lorundrostat pivotal program, partially offset by increased compensation and clinical supply costs Research and Development (R&D) Expenses (in millions) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :-------------------- | :---------- | :---------- | :----------- | | R&D Expenses | $38.3 million | $39.3 million | -$1.0 million | - The decrease in R&D expenses was primarily due to a $4.5 million decrease in preclinical and clinical costs, driven by the conclusion of the lorundrostat pivotal program in Q2 2025[6] - This decrease was partially offset by increases of $2.7 million in compensation expense (due to headcount additions, salaries, accrued bonuses, and stock-based compensation) and $0.8 million in higher clinical supply, manufacturing, regulatory, and other costs[6][8] General and Administrative (G&A) Expenses G&A expenses increased to $8.5 million in Q2 2025 from $5.9 million in Q2 2024, mainly attributed to higher compensation expenses, increased professional fees, and other administrative costs General and Administrative (G&A) Expenses (in millions) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :-------------------- | :---------- | :---------- | :----------- | | G&A Expenses | $8.5 million | $5.9 million | +$2.6 million | - The increase was primarily due to $1.9 million in higher compensation expense (headcount additions, salaries, accrued bonuses, and stock-based compensation), $0.6 million in higher professional fees, and $0.1 million in other administrative expenses[9] Total Other Income, Net Total other income, net, decreased to $3.5 million in Q2 2025 from $4.2 million in Q2 2024, primarily due to lower interest earned on investments resulting from reduced average cash balances Total Other Income, Net (in millions) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :-------------------- | :---------- | :---------- | :----------- | | Total Other Income, Net | $3.5 million | $4.2 million | -$0.7 million | - The decrease was primarily attributable to decreased interest earned on investments in money market funds and U.S. treasuries as a result of lower average cash balances invested during the quarter ended June 30, 2025[10] Net Loss Mineralys reported a net loss of $43.3 million for Q2 2025, an increase from $41.0 million in Q2 2024, primarily driven by the aforementioned changes in operating expenses Net Loss (in millions) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :---------- | :---------- | :---------- | :----------- | | Net Loss | $43.3 million | $41.0 million | +$2.3 million | - The increase in net loss was primarily attributable to the factors impacting the Company's expenses, including higher G&A expenses and partially offset R&D expenses[11] Conference Call Information Mineralys Therapeutics held a conference call on August 12, 2025, to discuss Q2 financial results and corporate updates, with a replay available online Conference Call Details Mineralys Therapeutics hosted a conference call on August 12, 2025, at 4:30 p.m. ET to discuss the financial results and corporate update, with a replay of the call available on the company's investor relations website - The company's management team hosted a conference call on August 12, 2025, at 4:30 p.m. ET[12] - A live webcast and replay of the call are available on the 'News & Events' page in the Investor Relations section of the Mineralys Therapeutics website[12] Disease Background This section provides background on hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA), highlighting their prevalence, economic burden, and link to dysregulated aldosterone About Hypertension Hypertension, or sustained elevated blood pressure, significantly increases the risk of heart disease, heart attack, and stroke, contributing to over 685,000 deaths in the US in 2022 and imposing an estimated annual economic burden of $219 billion - Hypertension increases the risk of heart disease, heart attack, and stroke, which are leading causes of death in the United States[13] - In 2022, over 685,000 deaths in the United States included hypertension as a primary or contributing cause, with an estimated annual economic burden of about $219 billion in 2019[13] - Less than 50% of hypertension patients achieve their BP goal with currently available medications, and dysregulated aldosterone levels are a key factor in approximately 30% of all hypertensive patients[13] About Chronic Kidney Disease (CKD) Chronic kidney disease (CKD) affects over 10% of the global population and is a leading cause of mortality, with approximately 37 million US adults having CKD, and dysregulated aldosterone identified as a key driver - CKD, characterized by gradual loss of kidney function, is estimated to affect more than 10% of the global population and is one of the leading causes of mortality worldwide[14] - Approximately 1-in-7 (37 million) U.S. adults have CKD, and about 22 million people in the United States are living with both hypertension and CKD[14] - Emerging evidence points to dysregulated aldosterone as a key driver of both diseases, promoting sodium retention, vascular inflammation, and fibrosis, contributing to uncontrolled BP and kidney injury[15] About Obstructive Sleep Apnea (OSA) Obstructive Sleep Apnea (OSA) impacts almost one billion people globally, with 425 million moderate-to-severe cases, and undiagnosed OSA cost the US approximately $149.6 billion annually in 2015, making it a major risk factor for cardiovascular disease - OSA impacts almost one billion people globally, including 425 million moderate-to-severe cases, with around 80% of adults with OSA being undiagnosed[16] - As of 2015, undiagnosed OSA is estimated to cost the United States approximately $149.6 billion annually from comorbid disease, workplace accidents, motor vehicle accidents, and loss of workplace productivity[16] - Between 30-50% of adults with hypertension have OSA, and this number increases to between 70-80% in adults with resistant hypertension, making it a major risk factor for cardiovascular disease, type-2 diabetes mellitus, and stroke[17] Product Candidate: Lorundrostat Lorundrostat is Mineralys' highly selective aldosterone synthase inhibitor, developed for uncontrolled/resistant hypertension, CKD, and OSA, with successful clinical trials supporting its efficacy and favorable safety profile About Lorundrostat Lorundrostat is Mineralys' proprietary, orally administered, highly selective aldosterone synthase inhibitor, developed for uncontrolled/resistant hypertension, CKD, and OSA, demonstrating high selectivity and a 40-70% reduction in plasma aldosterone concentration - Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled or resistant hypertension (uHTN or rHTN), as well as CKD and OSA[18] - It was designed to reduce aldosterone levels by inhibiting CYP11B2, demonstrating 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours, and a 40-70% reduction in plasma aldosterone concentration in hypertensive participants[18] - The Company has completed four successful clinical trials, including the pivotal Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, supporting its efficacy and safety profile with robust, durable, and clinically meaningful reductions in systolic BP[19] About Mineralys Therapeutics Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines for aldosterone-driven diseases, with lorundrostat as its lead candidate Company Profile Mineralys Therapeutics is a clinical-stage biopharmaceutical company based in Radnor, Pennsylvania, founded by Catalys Pacific, focusing on developing medicines for hypertension and related comorbidities driven by dysregulated aldosterone, with lorundrostat as its initial product candidate - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as CKD, OSA, and other diseases driven by dysregulated aldosterone[20] - Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor[20][21] - Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific[21] Forward-Looking Statements This section outlines cautionary statements regarding forward-looking information, emphasizing potential risks and uncertainties that could cause actual results to differ Disclaimer and Risk Factors This section contains cautionary statements regarding forward-looking information, emphasizing that actual results may differ from expectations due to inherent business risks, and the company disclaims any obligation to update these statements - Statements regarding matters that are not historical facts are forward-looking statements, based on current beliefs and expectations[22] - Actual results may differ due to inherent business risks, including: topline results being preliminary and subject to change, dependence on lorundrostat's success, potential delays in clinical trials, regulatory uncertainties with the FDA, reliance on third parties, unexpected adverse side effects or inadequate efficacy, unfavorable results from clinical trials, macroeconomic trends, and regulatory developments[22] - The company undertakes no obligation to update such statements to reflect events or circumstances that occur after the date of the press release[22] Financial Statements This section presents the unaudited condensed statements of operations and balance sheet data for Mineralys Therapeutics Condensed Statements of Operations The condensed statements of operations provide unaudited financial results for the three and six months ended June 30, 2025, and 2024, detailing operating expenses, loss from operations, other income, and net loss Condensed Statements of Operations (in thousands, except share and per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $38,278 | $39,273 | $76,157 | $70,027 | | General and administrative | $8,468 | $5,895 | $15,036 | $10,503 | | Total operating expenses | $46,746 | $45,168 | $91,193 | $80,530 | | Loss from operations | $(46,746) | $(45,168) | $(91,193) | $(80,530) | | Interest income, net | $3,474 | $4,152 | $5,713 | $8,005 | | Other income (expense) | $(2) | $2 | $(5) | $3 | | Total other income, net | $3,472 | $4,154 | $5,708 | $8,008 | | Net loss | $(43,274) | $(41,014) | $(85,485) | $(72,522) | | Net loss per share attributable to common stockholders, basic and diluted | $(0.66) | $(0.83) | $(1.44) | $(1.54) | | Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted | 65,451,297 | 49,356,287 | 59,341,368 | 47,178,288 | Condensed Balance Sheet Data The condensed balance sheet data provides unaudited financial positions as of June 30, 2025, and December 31, 2024, including cash, total assets, total liabilities, and total stockholders' equity Condensed Balance Sheet Data (amounts in thousands) | Metric | As of June 30, 2025 | As of December 31, 2024 | | :-------------------------------- | :------------------ | :---------------------- | | Cash, cash equivalents and investments | $324,916 | $198,187 | | Total assets | $335,724 | $205,903 | | Total liabilities | $22,173 | $14,646 | | Total stockholders' equity | $313,551 | $191,257 |