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]

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]

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].

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].

Core Viewpoint - Mineralys Therapeutics, Inc. (MLYS) has seen a 2% increase in share price over the past four weeks, closing at $14.52, with a potential upside of 149.7% based on Wall Street analysts' mean price target of $36.25 [1] Price Targets - The average price target consists of eight estimates ranging from a low of $15.00 to a high of $48.00, with a standard deviation of $11.25, indicating variability among analysts [2] - The lowest estimate suggests a 3.3% increase from the current price, while the highest estimate indicates a 230.6% upside [2] Analyst Sentiment - There is strong agreement among analysts regarding MLYS's ability to report better earnings than previously predicted, which supports the potential for stock upside [4] - Recent trends show that four earnings estimates have been revised higher in the last 30 days, with no negative revisions, leading to a 10.2% increase in the Zacks Consensus Estimate [12] Zacks Rank - MLYS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating a strong potential for upside [13] Conclusion on Price Targets - While the consensus price target may not be a reliable indicator of the extent of MLYS's potential gains, it does provide a useful guide for the direction of price movement [14]

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]

[Part I - Financial Information](index=4&type=section&id=Part%20I%20-%20Financial%20Information) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents Mineralys Therapeutics, Inc.'s unaudited condensed financial statements and related notes for periods ended June 30, 2025, and December 31, 2024 [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :----------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $101,788 | $114,091 | | Investments | $223,128 | $84,096 | | Total current assets | $335,269 | $205,351 | | Total assets | $335,724 | $205,903 | | Total current liabilities | $22,173 | $14,646 | | Total stockholders' equity | $313,551 | $191,257 | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) | Metric (in thousands) | 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 | | Net loss | $(43,274) | $(41,014) | $(85,485) | $(72,522) | | Net loss per share (basic and diluted) | $(0.66) | $(0.83) | $(1.44) | $(1.54) | [Condensed Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) | Metric (in thousands) | Balance as of December 31, 2024 | Balance as of June 30, 2025 | | :-------------------- | :------------------------------ | :-------------------------- | | Common Stock (Shares) | 49,821,915 | 65,725,409 |\ | Common Stock (Amount) | $5 | $6 |\ | Additional Paid-In Capital | $493,770 | $701,548 |\ | Accumulated Deficit | $(302,518) | $(388,003) |\ | Total Stockholders' Equity | $191,257 | $313,551 | - Issuance of common stock in a public offering, net of **$12.5 million** in offering costs, increased total stockholders' equity by **$188.7 million** for the six months ended June 30, 2025[16](index=16&type=chunk) - Issuance of common stock under the ATM Agreement, net of **$46 thousand** in issuance costs, contributed **$9.5 million** to total stockholders' equity for the six months ended June 30, 2025[16](index=16&type=chunk) [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(75,656) | $(49,285) | | Net cash used in investing activities | $(135,757) | $(48,216) | | Net cash provided by financing activities | $199,110 | $116,053 | | Net increase (decrease) in cash and cash equivalents | $(12,303) | $18,552 | | Cash and cash equivalents - ending | $101,788 | $67,856 | [Notes to Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) [Note 1. Nature of Business](index=9&type=section&id=Note%201.%20Nature%20of%20Business) - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing lorundrostat for cardiorenal conditions driven by dysregulated aldosterone[22](index=22&type=chunk) - The company has not generated revenue, incurred significant operating losses, and reported an accumulated deficit of **$388.0 million** as of June 30, 2025, with **$324.9 million** in cash, cash equivalents, and investments[23](index=23&type=chunk) - Operations are expected to be funded for at least twelve months from June 30, 2025, through equity offerings, debt financings, or strategic collaborations[24](index=24&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=9&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) - The unaudited condensed financial statements adhere to U.S. GAAP and SEC interim reporting rules, with certain footnotes condensed or omitted[25](index=25&type=chunk) - The Company operates in a single segment, with the CEO evaluating performance based on net loss and functional expenses[28](index=28&type=chunk) - The Company utilizes the Black-Scholes option pricing model for stock option awards, recognizing stock-based compensation expense straight-line over the service period[42](index=42&type=chunk)[47](index=47&type=chunk) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :-------------- | | Cash | $1,009 | $664 | | Cash equivalents | $100,779 | $113,427 | | Total cash and cash equivalents | $101,788 | $114,091 | [Note 3. Fair Value of Financial Instruments](index=13&type=section&id=Note%203.%20Fair%20Value%20of%20Financial%20Instruments) | Asset (in thousands) | June 30, 2025 (Level 1) | December 31, 2024 (Level 1) | | :------------------- | :---------------------- | :-------------------------- | | Money market funds | $95,818 | $83,602 | | U.S. Treasury Bills (in thousands) | Original Maturities | Amortized Cost (June 30, 2025) | Estimated Fair Value (June 30, 2025) | Amortized Cost (Dec 31, 2024) | Estimated Fair Value (Dec 31, 2024) | | :--------------------------------- | :------------------ | :----------------------------- | :----------------------------------- | :---------------------------- | :---------------------------------- | | Cash and cash equivalents | less than 3 months | $4,961 | $4,961 | $29,825 | $29,829 | | Investments | between 3 and 12 months | $223,128 | $223,085 | $84,096 | $84,123 | | Total | | $228,089 | $228,046 | $113,921 | $113,952 | [Note 4. Commitments and Contingencies](index=14&type=section&id=Note%204.%20Commitments%20and%20Contingencies) - The Company's license agreement with Mitsubishi Tanabe for lorundrostat includes potential commercial milestone payments up to **$155.0 million** and tiered royalties (**mid-single-digits to 10%**) on net sales[59](index=59&type=chunk) - No remaining development milestone obligations or related expenses were incurred under the Mitsubishi License for the three or six months ended June 30, 2025, and 2024[61](index=61&type=chunk) - The Company is not currently subject to any material legal proceedings or claims under indemnification agreements[64](index=64&type=chunk)[65](index=65&type=chunk) [Note 5. Accrued Liabilities](index=16&type=section&id=Note%205.%20Accrued%20Liabilities) | Accrued Liability (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------- | :------------ | :---------------- | | Research and development expenses | $14,656 | $8,614 | | Compensation and benefits | $2,623 | $3,582 | | Professional fees and other | $1,730 | $1,971 | | Total | $19,009 | $14,167 | [Note 6. Capital Stock](index=16&type=section&id=Note%206.%20Capital%20Stock) - As of June 30, 2025, the Company had **500 million** authorized common shares and **50 million** authorized undesignated preferred shares[68](index=68&type=chunk) - In March 2025, a public offering of **14,907,406** common shares at **$13.50** per share generated approximately **$188.7 million** in net proceeds for clinical development and general corporate purposes[69](index=69&type=chunk) - Under an ATM Agreement, **674,518** shares were sold from April to June 2025 for **$9.5 million** in net proceeds, with **$90.5 million** of ATM Shares remaining available as of June 30, 2025[72](index=72&type=chunk) - In February 2024, a private placement of common stock and pre-funded warrants generated approximately **$116.1 million** in net proceeds, primarily for lorundrostat R&D and working capital[73](index=73&type=chunk) [Note 7. Stock-Based Compensation](index=17&type=section&id=Note%207.%20Stock-Based%20Compensation) - The 2023 Incentive Award Plan allows for various stock-based awards, with **1,761,818** shares available for grant as of June 30, 2025[76](index=76&type=chunk)[83](index=83&type=chunk) - The 2025 Employment Inducement Incentive Award Plan, effective February 10, 2025, reserved **1 million** shares for new employee inducement awards, with no shares issued as of August 12, 2025[80](index=80&type=chunk) | Stock-Based Compensation Expense (in thousands) | 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 | $1,943 | $1,281 | $3,571 | $2,246 | | General and administrative | $2,610 | $1,591 | $4,627 | $2,817 | | Total | $4,553 | $2,872 | $8,198 | $5,063 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes Mineralys Therapeutics, Inc.'s financial condition and results of operations, including clinical trial results and liquidity, for periods ended June 30, 2025, and 2024 [Overview](index=21&type=section&id=Overview) - Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing lorundrostat for cardiorenal conditions such as hypertension, CKD, and OSA[95](index=95&type=chunk) - Over half of the **120 million** U.S. hypertension patients fail to achieve BP goals, with dysregulated aldosterone affecting approximately **30%** of these patients[95](index=95&type=chunk) - Positive results from pivotal trials (Advance-HTN, Launch-HTN) and the Phase 2 Explore-CKD trial for lorundrostat demonstrated efficacy and a favorable safety profile in H1 2025[96](index=96&type=chunk) [Clinical Program Highlights](index=21&type=section&id=Clinical%20Program%20Highlights) - Pivotal trials Launch-HTN and Advance-HTN for uncontrolled or resistant hypertension achieved statistically significant and clinically meaningful primary efficacy endpoints with a favorable safety profile[97](index=97&type=chunk) - The company plans a pre-NDA meeting with the FDA in **Q4 2025** for lorundrostat in uncontrolled/resistant hypertension[97](index=97&type=chunk) - Positive topline data from the Phase 2 Explore-CKD trial for lorundrostat in hypertensive participants with comorbid CKD showed high statistical significance and clinical meaningfulness in June 2025[98](index=98&type=chunk) - The FDA cleared an investigational new drug application for Explore-OSA in January 2025, with topline results for this Phase 2 trial anticipated in **H1 2026**[101](index=101&type=chunk) [Pivotal Program Clinical Trial Results](index=22&type=section&id=Pivotal%20Program%20Clinical%20Trial%20Results) [Efficacy Results](index=22&type=section&id=Efficacy%20Results) **Launch-HTN Phase 3 Trial (automated office systolic BP measure, n=1,083 randomized):** | Metric | Week 6 (50 mg pooled) Absolute Reduction | Week 6 (50 mg pooled) Placebo-Adjusted Reduction | Week 12 Absolute Reduction | Week 12 Placebo-Adjusted Reduction | | :----- | :--------------------------------------- | :----------------------------------------------- | :------------------------- | :--------------------------------- | | 50 mg | -16.9 mmHg | -9.1 mmHg (p<0.0001)* | -19.0 mmHg | -11.6 mmHg (p<0.0001) | | 50 to 100 mg | | | -15.7 mmHg | -8.4 mmHg (p=0.0016) | * Primary endpoint **Advance-HTN Phase 2 Trial (24-hour ambulatory systolic BP, n=285 randomized):** | Metric | Week 4 (50 mg pooled) Absolute Reduction | Week 4 (50 mg pooled) Placebo-Adjusted Reduction | Week 12 Absolute Reduction | Week 12 Placebo-Adjusted Reduction* | | :----- | :--------------------------------------- | :----------------------------------------------- | :------------------------- | :---------------------------------- | | 50 mg | -11.5 mmHg | -5.3 mmHg (p=0.0006) | -15.4 mmHg | -7.9 mmHg (p=0.001) | | 50 to 100 mg | | | -13.9 mmHg | -6.5 mmHg (p=0.006) | * Primary endpoint [Safety and Tolerability Results](index=23&type=section&id=Safety%20and%20Tolerability%20Results) - Clinical safety findings in Launch-HTN and Advance-HTN, including adrenocorticotropic hormone-stimulated and serum cortisol, serum potassium, serum sodium, and eGFR, support a favorable benefit-risk profile for lorundrostat[108](index=108&type=chunk) - In Launch-HTN, confirmed hyperkalemia incidence was **0.6%** (50 mg arm) and **1.1%** (50 to 100 mg arm) after excluding spurious results[109](index=109&type=chunk) - In Advance-HTN, confirmed hyperkalemia incidence was **2.1%** (50 mg arm) and **3.2%** (50 to 100 mg arm) after excluding spurious results[111](index=111&type=chunk) [Explore-CKD Clinical Trial Results](index=24&type=section&id=Explore-CKD%20Clinical%20Trial%20Results) **Explore-CKD Phase 2 Trial (N=59):** | Metric | Placebo | Lorundrostat 25 mg | Placebo-Adjusted | | :------------------------------------ | :------ | :----------------- | :--------------- | | Change in systolic BP (mmHg)* | -1.76 | -9.25 | -7.5 (p=0.0024) | | Change in spot UACR (mg/g) | -6.60% | -30.51% | -25.60% (p=0.0015) | | Change in eGFR** (mL/min/1.73m ) | -2.20% | -6.78% | -4.58% (p=0.0362) | | TEAEs leading to discontinuation of study drug | 1/57 (2%) | 2/58 (3%) | | | Confirmed hyperkalemia*** (K + >6.0 mmol/L) | 0/59 (0%) | 3/58 (5%) | | * Primary endpoint. ** Cystatin-C formula. *** Per protocol Systolic BP, UACR, and eGFR estimates and p values from Mixed Effects Model for a crossover trial with multiple baselines. - The Explore-CKD trial demonstrated highly statistically significant and clinically meaningful reductions in systolic BP and UACR, with a favorable safety and tolerability profile[112](index=112&type=chunk) - A modest, anticipated decrease in mean eGFR (**-4.6%** placebo-adjusted) was observed during lorundrostat treatment, consistent with other RAAS inhibitors[116](index=116&type=chunk) [Financial Overview](index=25&type=section&id=Financial%20Overview) - Since inception in May 2019, the Company has focused on business planning, capital raising, in-licensing lorundrostat, and R&D, incurring net losses and no product sales revenue[119](index=119&type=chunk)[120](index=120&type=chunk) | Metric (in millions) | June 30, 2025 | December 31, 2024 | | :------------------- | :------------ | :---------------- | | Cash, cash equivalents, and investments | $324.9 | | | Accumulated deficit | $388.0 | $302.5 | | Net loss (six months) | $85.5 | $72.5 | - The Company believes current cash, cash equivalents, and investments are sufficient to fund operations for at least twelve months, but anticipates substantial increases in expenses and operating losses due to ongoing clinical trials and regulatory activities[120](index=120&type=chunk)[121](index=121&type=chunk) [License Agreement with Mitsubishi Tanabe](index=26&type=section&id=License%20Agreement%20with%20Mitsubishi%20Tanabe) - The Company holds an exclusive, worldwide license from Mitsubishi Tanabe for lorundrostat, with remaining obligations for commercial milestone payments up to **$155.0 million** and tiered royalties (**mid-single-digits to 10%**) on net sales[122](index=122&type=chunk) - The Company is obligated to use commercially reasonable efforts to develop and seek regulatory approval for lorundrostat in major markets[123](index=123&type=chunk) [Public Offering](index=26&type=section&id=Public%20Offering) - In March 2025, the Company issued **14,907,406** common shares at **$13.50** per share, generating approximately **$188.7 million** in net proceeds[124](index=124&type=chunk) - Proceeds from the public offering are allocated to fund clinical development of lorundrostat (R&D, manufacturing, pre-commercialization), working capital, and general corporate purposes[124](index=124&type=chunk) [At Market Equity Offering Sales Agreement](index=26&type=section&id=At%20Market%20Equity%20Offering%20Sales%20Agreement) - Under an ATM Agreement established in March 2024, the Company can sell up to **$100.0 million** of common stock through sales agents[125](index=125&type=chunk) - From April to June 30, 2025, **674,518** ATM Shares were sold at a weighted-average price of **$14.15** per share, yielding approximately **$9.5 million** in net proceeds[126](index=126&type=chunk) - As of June 30, 2025, approximately **$90.5 million** of ATM Shares remained available for sale, with an additional **$7.9 million** in net proceeds from sales through August 12, 2025[126](index=126&type=chunk) [Private Placement Offering](index=27&type=section&id=Private%20Placement%20Offering) - In February 2024, a private placement of **8,339,169** common shares and **549,755** pre-funded warrants generated approximately **$116.1 million** in aggregate net proceeds[127](index=127&type=chunk) - Net proceeds from the private placement fund lorundrostat research and development and general working capital[127](index=127&type=chunk) - Pre-funded warrants are immediately exercisable at **$0.001** per share, with beneficial ownership limitations of **4.99%**, **9.99%**, or **19.99%** as selected by the holder[128](index=128&type=chunk) [Key Components of Results of Operations](index=27&type=section&id=Key%20Components%20of%20Results%20of%20Operations) [Operating Expenses](index=27&type=section&id=Operating%20Expenses) [Research and Development](index=27&type=section&id=Research%20and%20Development) - R&D expenses primarily include external costs (CROs, consultants, manufacturing for clinical trials) and internal costs (personnel-related expenses, stock-based compensation)[130](index=130&type=chunk)[132](index=132&type=chunk) - R&D expenses are expected to increase substantially due to ongoing and planned clinical trials, regulatory approvals, and commercial readiness activities for lorundrostat[131](index=131&type=chunk)[132](index=132&type=chunk) - Future development costs are highly variable, depending on trial scope, regulatory feedback, manufacturing costs, and potential collaborations[131](index=131&type=chunk)[133](index=133&type=chunk) [General and Administrative Expenses](index=29&type=section&id=General%20and%20Administrative%20Expenses) - G&A expenses primarily consist of personnel-related costs (salaries, bonuses, stock-based compensation) for executive and administrative functions, along with legal, accounting, and consulting fees[134](index=134&type=chunk) - G&A expenses are expected to increase to support expanded R&D and manufacturing activities, and public company operating costs, including additional personnel and compliance[134](index=134&type=chunk) [Other Income, Net](index=29&type=section&id=Other%20Income%2C%20Net) [Interest Income, Net](index=29&type=section&id=Interest%20Income%2C%20Net) - Interest income is generated from investments in money market funds and U.S. treasuries, net of fees[135](index=135&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) [Comparison of the Three Months Ended June 30, 2025 and 2024](index=29&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | | :-------------------- | :------------ | :------------ | :----- | | Research and development expenses | $(38,278) | $(39,273) | $995 | | General and administrative expenses | $(8,468) | $(5,895) | $(2,573) | | Total other income, net | $3,472 | $4,154 | $(682) | | Net loss | $(43,274) | $(41,014) | $(2,260) | - R&D expenses decreased by **$1.0 million**, primarily due to a **$4.5 million** decrease in preclinical and clinical costs from the conclusion of the lorundrostat pivotal program, partially offset by increased compensation and clinical supply costs[137](index=137&type=chunk) - G&A expenses increased by **$2.6 million**, mainly due to **$1.9 million** higher compensation expenses from headcount additions, salary increases, and stock-based compensation, along with increased professional fees[138](index=138&type=chunk) - Total other income, net, decreased by **$0.7 million** due to lower average cash balances invested, resulting in decreased interest earned[139](index=139&type=chunk)[140](index=140&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=30&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | | :-------------------- | :------------ | :------------ | :----- | | Research and development expenses | $(76,157) | $(70,027) | $(6,130) | | General and administrative expenses | $(15,036) | $(10,503) | $(4,533) | | Total other income, net | $5,708 | $8,008 | $(2,300) | | Net loss | $(85,485) | $(72,522) | $(12,963) | - R&D expenses increased by **$6.1 million**, primarily driven by a **$5.6 million** increase in compensation expenses due to headcount additions, salary increases, and stock-based compensation[142](index=142&type=chunk) - G&A expenses increased by **$4.5 million**, mainly due to a **$3.1 million** increase in compensation expenses and a **$1.3 million** increase in professional fees[143](index=143&type=chunk) - Total other income, net, decreased by **$2.3 million**, primarily due to lower average cash balances invested[144](index=144&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) - The Company has incurred net losses and negative cash flows from operations since inception, with an accumulated deficit of **$388.0 million** as of June 30, 2025[145](index=145&type=chunk) - Since inception, the Company has raised approximately **$717.4 million** in gross proceeds from various equity and warrant sales[145](index=145&type=chunk) - As of June 30, 2025, cash, cash equivalents, and investments totaled **$324.9 million**, believed sufficient to fund operations for at least twelve months[145](index=145&type=chunk)[147](index=147&type=chunk) [Funding Requirements](index=31&type=section&id=Funding%20Requirements) - Future capital requirements depend on factors such as clinical trial timing and costs, regulatory approvals, manufacturing, intellectual property protection, and commercialization efforts[148](index=148&type=chunk) - The Company expects to finance future cash needs through equity offerings, debt financings, or strategic collaborations, facing risks of dilution, restrictive covenants, and adverse market conditions[149](index=149&type=chunk) - Failure to raise additional funds on favorable terms could force delays, reductions, or termination of product development and commercialization efforts[149](index=149&type=chunk) [Cash Flows](index=33&type=section&id=Cash%20Flows) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=33&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :-------------------------------- | :----------------------------- | :----------------------------- | :----- | | Net cash used in operating activities | $(75,656) | $(49,285) | $(26,371) | | Net cash used in investing activities | $(135,757) | $(48,216) | $(87,541) | | Net cash provided by financing activities | $199,110 | $116,053 | $83,057 | [Operating Activities](index=33&type=section&id=Operating%20Activities) - Net cash used in operating activities increased by **$26.4 million** to **$75.7 million** for the six months ended June 30, 2025, primarily due to increased cash used for lorundrostat development, clinical trial expenses, personnel costs, and professional fees[152](index=152&type=chunk) [Investing Activities](index=33&type=section&id=Investing%20Activities) - Net cash used in investing activities increased by **$87.5 million** to **$135.8 million** for the six months ended June 30, 2025, mainly driven by the timing and volume of marketable securities purchases and maturities[153](index=153&type=chunk) [Financing Activities](index=33&type=section&id=Financing%20Activities) - Net cash provided by financing activities increased by **$83.1 million** to **$199.1 million** for the six months ended June 30, 2025[154](index=154&type=chunk) - This increase was primarily due to **$188.9 million** from a public offering and **$8.9 million** from ATM Share sales in 2025, compared to **$116.1 million** from a private placement in 2024[154](index=154&type=chunk) [Contractual Obligations and Commitments](index=33&type=section&id=Contractual%20Obligations%20and%20Commitments) - The Company has contingent milestone and royalty payment obligations under the Mitsubishi License, currently unestimable in timing or likelihood[155](index=155&type=chunk) - Other contracts for research, manufacturing, and professional services are generally cancelable after a notice period[156](index=156&type=chunk) [Critical Accounting Estimates](index=34&type=section&id=Critical%20Accounting%20Estimates) - No material changes occurred in critical accounting estimates during the six months ended June 30, 2025, as disclosed in the Annual Report on Form 10-K for 2024[158](index=158&type=chunk) [JOBS Act and Smaller Reporting Company Status](index=34&type=section&id=JOBS%20Act%20and%20Smaller%20Reporting%20Company%20Status) - The Company, an EGC, elected the extended transition period for new accounting standards, potentially making its financial statements non-comparable to other public companies[159](index=159&type=chunk) - The Company remains an EGC until the earliest of five years post-IPO, **$1.235 billion** in annual gross revenue, becoming a large accelerated filer, or issuing over **$1.0 billion** in non-convertible debt[160](index=160&type=chunk) - The Company also qualifies as a smaller reporting company, allowing for scaled disclosures[161](index=161&type=chunk) [Recently Issued Accounting Pronouncements](index=35&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) - The Company reviewed recently issued accounting pronouncements and determined no material impact on its condensed financial statements or operations, beyond prior disclosures[162](index=162&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the Company's exposure to market risks, including interest rate, foreign currency, and inflation, and their potential financial impact [Interest Rate Risk](index=35&type=section&id=Interest%20Rate%20Risk) - The Company is exposed to interest rate risk from its investment portfolio, primarily money market funds and U.S. treasury securities[163](index=163&type=chunk) - An immediate hypothetical **10%** change in interest rates is not expected to materially affect the Company's results of operations[163](index=163&type=chunk) [Foreign Currency Exchange Risk](index=35&type=section&id=Foreign%20Currency%20Exchange%20Risk) - The Company is exposed to foreign currency exchange risk from contracts with international vendors denominated in foreign currencies[164](index=164&type=chunk) - Foreign currency fluctuations have not been significant to date; a hypothetical **10%** change in exchange rates is not expected to have a material effect[164](index=164&type=chunk) [Effects of Inflation](index=35&type=section&id=Effects%20of%20Inflation) - Inflation primarily affects the Company by increasing labor and research and development contract costs[165](index=165&type=chunk) - While inflation has not had a material impact to date, future effects on clinical trial costs, labor, and operational expenses could adversely affect the business[165](index=165&type=chunk) [Item 4. Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the Company's disclosure controls and procedures, including management's evaluation and any changes in internal control [Evaluation of Disclosure Controls and Procedures](index=35&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - The Company maintains disclosure controls and procedures designed to ensure timely and accurate reporting of information required by SEC rules[166](index=166&type=chunk) - Management acknowledges that controls provide only reasonable, not absolute, assurance, involving judgment in evaluating cost-benefit relationships[166](index=166&type=chunk) [Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures](index=36&type=section&id=Conclusion%20Regarding%20the%20Effectiveness%20of%20Disclosure%20Controls%20and%20Procedures) - As of June 30, 2025, the principal executive and financial officers concluded the Company's disclosure controls and procedures were effective at a reasonable assurance level[167](index=167&type=chunk) [Changes in Internal Control over Financial Reporting](index=36&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - Management determined no material changes in internal control over financial reporting during the three months ended June 30, 2025[168](index=168&type=chunk) [Part II - Other Information](index=37&type=section&id=Part%20II%20-%20Other%20Information) [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The Company is not currently a party to any material legal proceedings - The Company is not currently a party to any material legal proceedings, though it may become involved in ordinary course litigation[169](index=169&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) This section updates the Company's risk factors, including inflation and trade policy changes, and their potential adverse effects - The inflation risk factor now includes adverse effects of trade policy changes, such as tariffs, potentially increasing procurement costs or necessitating supplier transitions[171](index=171&type=chunk) - Elevated inflation, geopolitical conflicts, and global supply chain disruptions contribute to economic uncertainty, potentially making future financing more difficult, costly, or dilutive[172](index=172&type=chunk)[173](index=173&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period - No unregistered sales of equity securities and use of proceeds were reported[174](index=174&type=chunk) [Item 3. Defaults Upon Senior Securities](index=38&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities are reported - This item is not applicable, indicating no defaults upon senior securities[175](index=175&type=chunk) [Item 4. Mine Safety Disclosures](index=38&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the Company - This item is not applicable, indicating no mine safety disclosures[176](index=176&type=chunk) [Item 5. Other Information](index=38&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the three months ended June 30, 2025 - No directors or officers adopted or terminated any Rule 10b5-1 trading arrangements during the three months ended June 30, 2025[177](index=177&type=chunk) [Item 6. Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including organizational documents, certifications, and XBRL data files | Exhibit Number | Exhibit Description | Incorporated by Reference Form | Date | Number | Filed Herewith | | :------------- | :------------------------------------------------------------------------------------------------------ | :----------------------------- | :------- | :----- | :------------- | | 3.1 | Amended and Restated Certificate of Incorporation | 8-K | 2/14/23 | 3.1 | | | 3.2 | Amended and Restated Bylaws | 8-K | 2/14/23 | 3.2 | | | 31.1 | Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | | | x | | 31.2 | Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | | | x | | 32.1* | Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | | | | x | | 32.2* | Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | | | | x | | 101.INS | XBRL Instance Document | | | | x | | 101.SCH | XBRL Taxonomy Extension Schema Document | | | | x | | 101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | | | | x | | 101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | | | | x | | 101.LAB | XBRL Taxonomy Extension Label Linkbase Document | | | | x | | 101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | | | | x | | 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | | | | x | * This certification is deemed not filed for the purpose of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act. [SIGNATURES](index=39&type=section&id=SIGNATURES) - The report is signed by Jon Congleton, President and Chief Executive Officer, and Adam Levy, Chief Financial Officer and Secretary, on August 12, 2025[183](index=183&type=chunk)

[Corporate Update](index=1&type=section&id=Corporate%20Update) 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](index=1&type=section&id=Company%20Overview%20and%20CEO%20Statement) 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](index=2&type=chunk) - 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](index=3&type=chunk) - A pre-NDA meeting with the FDA is scheduled for the **fourth quarter of 2025**, advancing the company's NDA strategy[1](index=1&type=chunk)[3](index=3&type=chunk) [Recent Clinical Highlights and Upcoming Milestones](index=1&type=section&id=Recent%20Clinical%20Highlights%20and%20Upcoming%20Milestones) 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](index=4&type=chunk)[7](index=7&type=chunk) - 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](index=7&type=chunk) 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](index=7&type=chunk) [Second Quarter 2025 Financial Highlights](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Highlights) 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](index=2&type=section&id=Cash%2C%20Cash%20Equivalents%20and%20Investments) 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](index=5&type=chunk) [Research and Development (R&D) Expenses](index=2&type=section&id=Research%20and%20Development%20%28R%26D%29%20Expenses) 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](index=6&type=chunk) - 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](index=6&type=chunk)[8](index=8&type=chunk) [General and Administrative (G&A) Expenses](index=3&type=section&id=General%20and%20Administrative%20%28G%26A%29%20Expenses) 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](index=9&type=chunk) [Total Other Income, Net](index=3&type=section&id=Total%20Other%20Income%2C%20Net) 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](index=10&type=chunk) [Net Loss](index=3&type=section&id=Net%20Loss) 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](index=11&type=chunk) [Conference Call Information](index=3&type=section&id=Conference%20Call%20Information) 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](index=3&type=section&id=Conference%20Call%20Details) 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](index=12&type=chunk) - 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](index=12&type=chunk) [Disease Background](index=3&type=section&id=Disease%20Background) 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](index=3&type=section&id=About%20Hypertension) 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](index=13&type=chunk) - 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](index=13&type=chunk) - 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](index=13&type=chunk) [About Chronic Kidney Disease (CKD)](index=3&type=section&id=About%20Chronic%20Kidney%20Disease%20%28CKD%29) 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](index=14&type=chunk) - 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](index=14&type=chunk) - 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](index=15&type=chunk) [About Obstructive Sleep Apnea (OSA)](index=4&type=section&id=About%20Obstructive%20Sleep%20Apnea%20%28OSA%29) 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](index=16&type=chunk) - 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](index=16&type=chunk) - 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](index=17&type=chunk) [Product Candidate: Lorundrostat](index=4&type=section&id=Product%20Candidate%3A%20Lorundrostat) 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](index=4&type=section&id=About%20Lorundrostat) 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](index=18&type=chunk) - 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](index=18&type=chunk) - 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](index=19&type=chunk) [About Mineralys Therapeutics](index=4&type=section&id=About%20Mineralys%20Therapeutics) Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines for aldosterone-driven diseases, with lorundrostat as its lead candidate [Company Profile](index=4&type=section&id=Company%20Profile) 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](index=20&type=chunk) - Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor[20](index=20&type=chunk)[21](index=21&type=chunk) - Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific[21](index=21&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) 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](index=5&type=section&id=Disclaimer%20and%20Risk%20Factors) 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](index=22&type=chunk) - 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](index=22&type=chunk) - The company undertakes no obligation to update such statements to reflect events or circumstances that occur after the date of the press release[22](index=22&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) This section presents the unaudited condensed statements of operations and balance sheet data for Mineralys Therapeutics [Condensed Statements of Operations](index=7&type=section&id=Condensed%20Statements%20of%20Operations) 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](index=7&type=section&id=Condensed%20Balance%20Sheet%20Data) 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 |

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]

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]