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Mineralys Therapeutics(MLYS) - 2025 Q2 - Quarterly Report

Part I - Financial Information Item 1. Financial Statements 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 | 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 | 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 | 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, 202516 - 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, 202516 Condensed Statements of Cash Flows | 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 Note 1. Nature of Business - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing lorundrostat for cardiorenal conditions driven by dysregulated aldosterone22 - 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 investments23 - Operations are expected to be funded for at least twelve months from June 30, 2025, through equity offerings, debt financings, or strategic collaborations24 Note 2. Summary of Significant Accounting Policies - The unaudited condensed financial statements adhere to U.S. GAAP and SEC interim reporting rules, with certain footnotes condensed or omitted25 - The Company operates in a single segment, with the CEO evaluating performance based on net loss and functional expenses28 - The Company utilizes the Black-Scholes option pricing model for stock option awards, recognizing stock-based compensation expense straight-line over the service period4247 | 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 | 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 - 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 sales59 - 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 202461 - The Company is not currently subject to any material legal proceedings or claims under indemnification agreements6465 Note 5. Accrued Liabilities | 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 - As of June 30, 2025, the Company had 500 million authorized common shares and 50 million authorized undesignated preferred shares68 - 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 purposes69 - 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, 202572 - 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 capital73 Note 7. Stock-Based Compensation - The 2023 Incentive Award Plan allows for various stock-based awards, with 1,761,818 shares available for grant as of June 30, 20257683 - 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, 202580 | 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 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 - Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing lorundrostat for cardiorenal conditions such as hypertension, CKD, and OSA95 - Over half of the 120 million U.S. hypertension patients fail to achieve BP goals, with dysregulated aldosterone affecting approximately 30% of these patients95 - 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 202596 Clinical Program Highlights - 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 profile97 - The company plans a pre-NDA meeting with the FDA in Q4 2025 for lorundrostat in uncontrolled/resistant hypertension97 - 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 202598 - 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 2026101 Pivotal Program Clinical Trial Results Efficacy Results 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 - 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 lorundrostat108 - In Launch-HTN, confirmed hyperkalemia incidence was 0.6% (50 mg arm) and 1.1% (50 to 100 mg arm) after excluding spurious results109 - In Advance-HTN, confirmed hyperkalemia incidence was 2.1% (50 mg arm) and 3.2% (50 to 100 mg arm) after excluding spurious results111 Explore-CKD Clinical Trial Results 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 profile112 - A modest, anticipated decrease in mean eGFR (-4.6% placebo-adjusted) was observed during lorundrostat treatment, consistent with other RAAS inhibitors116 Financial Overview - 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 revenue119120 | 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 activities120121 License Agreement with Mitsubishi Tanabe - 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 sales122 - The Company is obligated to use commercially reasonable efforts to develop and seek regulatory approval for lorundrostat in major markets123 Public Offering - In March 2025, the Company issued 14,907,406 common shares at $13.50 per share, generating approximately $188.7 million in net proceeds124 - Proceeds from the public offering are allocated to fund clinical development of lorundrostat (R&D, manufacturing, pre-commercialization), working capital, and general corporate purposes124 At Market Equity Offering Sales Agreement - Under an ATM Agreement established in March 2024, the Company can sell up to $100.0 million of common stock through sales agents125 - 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 proceeds126 - 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, 2025126 Private Placement Offering - 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 proceeds127 - Net proceeds from the private placement fund lorundrostat research and development and general working capital127 - 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 holder128 Key Components of Results of Operations Operating Expenses Research and Development - R&D expenses primarily include external costs (CROs, consultants, manufacturing for clinical trials) and internal costs (personnel-related expenses, stock-based compensation)130132 - R&D expenses are expected to increase substantially due to ongoing and planned clinical trials, regulatory approvals, and commercial readiness activities for lorundrostat131132 - Future development costs are highly variable, depending on trial scope, regulatory feedback, manufacturing costs, and potential collaborations131133 General and Administrative Expenses - 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 fees134 - G&A expenses are expected to increase to support expanded R&D and manufacturing activities, and public company operating costs, including additional personnel and compliance134 Other Income, Net Interest Income, Net - Interest income is generated from investments in money market funds and U.S. treasuries, net of fees135 Results of Operations Comparison of the Three Months Ended June 30, 2025 and 2024 | 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 costs137 - 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 fees138 - Total other income, net, decreased by $0.7 million due to lower average cash balances invested, resulting in decreased interest earned139140 Comparison of the Six Months Ended June 30, 2025 and 2024 | 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 compensation142 - 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 fees143 - Total other income, net, decreased by $2.3 million, primarily due to lower average cash balances invested144 Liquidity and Capital Resources - 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, 2025145 - Since inception, the Company has raised approximately $717.4 million in gross proceeds from various equity and warrant sales145 - As of June 30, 2025, cash, cash equivalents, and investments totaled $324.9 million, believed sufficient to fund operations for at least twelve months145147 Funding Requirements - Future capital requirements depend on factors such as clinical trial timing and costs, regulatory approvals, manufacturing, intellectual property protection, and commercialization efforts148 - 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 conditions149 - Failure to raise additional funds on favorable terms could force delays, reductions, or termination of product development and commercialization efforts149 Cash Flows Comparison of the Six Months Ended June 30, 2025 and 2024 | 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 - 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 fees152 Investing Activities - 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 maturities153 Financing Activities - Net cash provided by financing activities increased by $83.1 million to $199.1 million for the six months ended June 30, 2025154 - 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 2024154 Contractual Obligations and Commitments - The Company has contingent milestone and royalty payment obligations under the Mitsubishi License, currently unestimable in timing or likelihood155 - Other contracts for research, manufacturing, and professional services are generally cancelable after a notice period156 Critical Accounting Estimates - 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 2024158 JOBS Act and Smaller Reporting Company Status - The Company, an EGC, elected the extended transition period for new accounting standards, potentially making its financial statements non-comparable to other public companies159 - 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 debt160 - The Company also qualifies as a smaller reporting company, allowing for scaled disclosures161 Recently Issued Accounting Pronouncements - The Company reviewed recently issued accounting pronouncements and determined no material impact on its condensed financial statements or operations, beyond prior disclosures162 Item 3. Quantitative and Qualitative Disclosures About Market Risk 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 - The Company is exposed to interest rate risk from its investment portfolio, primarily money market funds and U.S. treasury securities163 - An immediate hypothetical 10% change in interest rates is not expected to materially affect the Company's results of operations163 Foreign Currency Exchange Risk - The Company is exposed to foreign currency exchange risk from contracts with international vendors denominated in foreign currencies164 - Foreign currency fluctuations have not been significant to date; a hypothetical 10% change in exchange rates is not expected to have a material effect164 Effects of Inflation - Inflation primarily affects the Company by increasing labor and research and development contract costs165 - While inflation has not had a material impact to date, future effects on clinical trial costs, labor, and operational expenses could adversely affect the business165 Item 4. Controls and Procedures 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 - The Company maintains disclosure controls and procedures designed to ensure timely and accurate reporting of information required by SEC rules166 - Management acknowledges that controls provide only reasonable, not absolute, assurance, involving judgment in evaluating cost-benefit relationships166 Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures - 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 level167 Changes in Internal Control over Financial Reporting - Management determined no material changes in internal control over financial reporting during the three months ended June 30, 2025168 Part II - Other Information Item 1. Legal Proceedings 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 litigation169 Item 1A. Risk Factors 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 transitions171 - Elevated inflation, geopolitical conflicts, and global supply chain disruptions contribute to economic uncertainty, potentially making future financing more difficult, costly, or dilutive172173 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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 reported174 Item 3. Defaults Upon Senior Securities No defaults upon senior securities are reported - This item is not applicable, indicating no defaults upon senior securities175 Item 4. Mine Safety Disclosures Mine safety disclosures are not applicable to the Company - This item is not applicable, indicating no mine safety disclosures176 Item 5. Other Information 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, 2025177 Item 6. Exhibits 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 - The report is signed by Jon Congleton, President and Chief Executive Officer, and Adam Levy, Chief Financial Officer and Secretary, on August 12, 2025183