Mineralys Therapeutics, Inc.
For the period ended Sep 30, 2026. Filed Nov 4, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 4, 2026
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Item 1. Financial Statements
Condensed Balance Sheets
(in thousands, except share and per share data)
| September 30, | December 31, | |
|---|---|---|
| 2026 | 2025 | |
| (unaudited) | ||
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | $101,273 | $172,921 |
| Investments | 523,399 | 483,714 |
| Prepaid and other current assets | 3,322 | 4,751 |
| Total current assets | 627,994 | 661,386 |
| Property and equipment, net | 21 | 38 |
| Other assets | 2,108 | 382 |
| Total assets | $630,123 | $661,806 |
| Liabilities and stockholders’ equity | ||
| Current liabilities: | ||
| Accounts payable | $738 | $2,017 |
| Accrued liabilities | 27,337 | 13,096 |
| Senior secured term loan, current portion | 25,000 | — |
| Total current liabilities | 53,075 | 15,113 |
| Long-term liabilities: | ||
| Senior secured term loan, net of current portion | 73,273 | — |
| Total liabilities | 126,348 | 15,113 |
| Commitments and contingencies (Note 5) | ||
| Stockholders’ equity: | ||
| Common stock, $0.0001 par value; 500,000,000 shares authorized as of September 30, 2026 and December 31, 2025; 88,530,322 and 81,536,557 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively | 9 | 8 |
| Additional paid-in capital | 1,298,673 | 1,103,854 |
| Accumulated deficit | (794,907) | (457,169) |
| Total stockholders’ equity | 503,775 | 646,693 |
| Total liabilities and stockholders’ equity | $630,123 | $661,806 |
Condensed Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2026 | 2025 | 2026 | 2025 | |
| Operating expenses: | ||||
| Research and development | $22,668 | $31,450 | $268,410 | $107,607 |
| General and administrative | 37,419 | 9,681 | 83,057 | 24,717 |
| Total operating expenses | 60,087 | 41,131 | 351,467 | 132,324 |
| Loss from operations | (60,087) | (41,131) | (351,467) | (132,324) |
| Other income (expense), net: | ||||
| Interest and other income | 5,947 | 4,199 | 17,752 | 9,907 |
| Interest expense | (3,188) | — | (4,023) | — |
| Total other income, net | 2,759 | 4,199 | 13,729 | 9,907 |
| Net loss | $(57,328) | $(36,932) | $(337,738) | $(122,417) |
| Net loss per share attributable to common stockholders, basic and diluted | $(0.64) | $(0.52) | $(3.95) | $(1.94) |
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 88,986,795 | 70,594,504 | 85,538,811 | 63,133,634 |
Condensed Statements of Stockholders’ Equity
(in thousands, except share data)
| Common Stock · Additional Paid-In Capital · Accumulated Deficit · Total Stockholders’ Equity | |||||
|---|---|---|---|---|---|
| Shares · Amount | |||||
| Balance as of December 31, 2024 | 49,821,915 | $5 | $493,770 | $(302,518) | $191,257 |
| Issuance of common stock in public offering, net of offering costs of $12,509 | 14,907,406 | 1 | 188,740 | — | 188,741 |
| Issuance of common stock from stock option exercises | 146,907 | — | 123 | — | 123 |
| Stock-based compensation | — | — | 3,645 | — | 3,645 |
| Net loss | — | — | — | (42,211) | (42,211) |
| Balance as of March 31, 2025 | 64,876,228 | 6 | 686,278 | (344,729) | 341,555 |
| Issuance of common stock pursuant to Prior ATM Agreement, net of issuance costs of $46 | 674,518 | — | 9,496 | — | 9,496 |
| Issuance of common stock from stock option exercises | 161,059 | — | 1,079 | — | 1,079 |
| Issuance of common stock for cash under employee stock purchase plan | 13,604 | — | 142 | — | 142 |
| Stock-based compensation | — | — | 4,553 | — | 4,553 |
| Net loss | — | — | — | (43,274) | (43,274) |
| Balance as of June 30, 2025 | 65,725,409 | 6 | 701,548 | (388,003) | 313,551 |
| Issuance of common stock in public offering, net of offering costs of $17,932 | 11,274,509 | 2 | 269,566 | — | 269,568 |
| Issuance of common stock pursuant to Prior ATM Agreement, net of issuance costs of $88 | 1,239,522 | — | 17,775 | — | 17,775 |
| Issuance of common stock from stock option exercises | 730,019 | — | 6,624 | — | 6,624 |
| Stock-based compensation | — | — | 5,841 | — | 5,841 |
| Net loss | — | — | — | (36,932) | (36,932) |
| Balance as of September 30, 2025 | 78,969,459 | $8 | $1,001,354 | $(424,935) | $576,427 |
Condensed Statements of Stockholders’ Equity (Continued)
(in thousands, except share data)
| Common Stock · Additional Paid-In Capital · Accumulated Deficit · Total Stockholders’ Equity | |||||
|---|---|---|---|---|---|
| Shares · Amount | |||||
| Balance as of December 31, 2025 | 81,536,557 | $8 | $1,103,854 | $(457,169) | $646,693 |
| Issuance of common stock pursuant to ATM Agreement, net of issuance costs and shelf offering costs of $82 | 568,320 | — | 20,187 | — | 20,187 |
| Issuance of common stock from stock option exercises | 350,073 | — | 4,055 | — | 4,055 |
| Stock-based compensation | — | — | 6,548 | — | 6,548 |
| Net loss | — | — | — | (39,339) | (39,339) |
| Balance as of March 31, 2026 | 82,454,950 | 8 | 1,134,644 | (496,508) | 638,144 |
| Issuance of common stock in public offering, net of offering costs of $6,419 | 5,660,378 | 1 | 143,580 | — | 143,581 |
| Issuance of common stock from stock option exercises | 223,148 | — | 2,616 | — | 2,616 |
| Issuance of common stock for cash under employee stock purchase plan | 12,720 | — | 292 | — | 292 |
| Stock-based compensation | — | — | 7,355 | — | 7,355 |
| Net loss | — | — | — | (241,071) | (241,071) |
| Balance as of June 30, 2026 | 88,351,196 | 9 | 1,288,487 | (737,579) | 550,917 |
| Costs pursuant to ATM Agreement of $18 | — | — | (18) | — | (18) |
| Issuance of common stock from stock option exercises | 179,126 | — | 2,324 | — | 2,324 |
| Stock-based compensation | — | — | 7,880 | — | 7,880 |
| Net loss | — | — | — | (57,328) | (57,328) |
| Balance as of September 30, 2026 | 88,530,322 | $9 | $1,298,673 | $(794,907) | $503,775 |
Condensed Statements of Cash Flows
(in thousands)
| Nine Months Ended | ||
|---|---|---|
| September 30, | ||
| 2026 | 2025 | |
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||
| Net loss | $(337,738) | $(122,417) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||
| Upfront payment pursuant to Fourth Amendment to License Agreement | 200,000 | — |
| Stock-based compensation | 21,783 | 14,039 |
| Accretion of discount on held-to-maturity securities | (14,262) | (5,671) |
| Amortization of debt discount and issuance costs related to senior secured term loan | 972 | — |
| Depreciation and amortization | 17 | 46 |
| Changes in operating assets and liabilities: | ||
| Accrued interest receivable | 183 | 15 |
| Prepaid, other current assets, and other assets | 999 | 902 |
| Accounts payable and accrued liabilities | 12,923 | 8,558 |
| Net cash used in operating activities | (115,123) | (104,528) |
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||
| Purchases of marketable securities | (945,424) | (546,264) |
| Maturities of marketable securities | 920,000 | 260,000 |
| Upfront payment pursuant to Fourth Amendment to License Agreement | (200,000) | — |
| Security deposits | (38) | — |
| Net cash used in investing activities | (225,462) | (286,264) |
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||
| Proceeds from issuance of common stock in public offerings, net of offering costs | 143,584 | 459,080 |
| Proceeds from senior secured term loan, net of debt discount and issuance costs with lender | 97,503 | — |
| Payment of debt issuance costs with third parties | (1,639) | — |
| Proceeds from issuance of common stock pursuant to ATM Agreement, net of ATM issuance costs | 20,218 | 27,336 |
| Proceeds from stock option exercises | 8,995 | 7,826 |
| Proceeds from issuance of common stock for cash under employee stock purchase plan | 292 | 142 |
| Payment of shelf offering costs | (16) | (86) |
| Net cash provided by financing activities | 268,937 | 494,298 |
| Net increase (decrease) in cash and cash equivalents | (71,648) | 103,506 |
| Cash and cash equivalents – beginning | 172,921 | 114,091 |
| Cash and cash equivalents – ending (1) | $101,273 | $217,597 |
| Supplemental Disclosure of Non-Cash Financing Activities: | ||
| Accretion of exit consideration on senior secured term loan | $268 | $— |
| Offering costs included in accounts payable and accrued liabilities | $38 | $317 |
(1)Cash and cash equivalents as of September 30, 2026 exclude investments of $523.4 million. Cash, cash equivalents, and investments amounted to $624.7 million as of September 30, 2026.
Note 1. Nature of Business
Mineralys Therapeutics, Inc. (the Company) is a biopharmaceutical company focused on developing medicines to target diseases driven by dysregulated aldosterone. The Company’s product candidate, lorundrostat, is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor that the Company is developing for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as related comorbidities, such as chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases driven by dysregulated aldosterone. The Company has completed six late-stage clinical trials of lorundrostat supporting its efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The clinical program includes two pivotal clinical trials of lorundrostat for hypertension, one Phase 2 clinical trial in hypertensive participants with CKD, and one Phase 2 clinical trial in hypertensive participants with OSA. The Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in December 2025 for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs. The FDA accepted the NDA submission for lorundrostat and provided the Company with a Prescription Drug User Fee Act target date of December 22, 2026. The Company was incorporated as a Delaware corporation in May 2019 and is headquartered in Radnor, Pennsylvania. The Company’s operations to date have been limited to funding research and development activities, business planning, establishing and maintaining the Company’s intellectual property portfolio, advancing regulatory activities, staffing the Company, conducting commercial-readiness activities, raising capital, and providing general and administrative support for the Company’s operations.
Liquidity and Capital Resources
Since its inception, the Company has not generated any revenue from product sales or other sources and has incurred significant operating losses and negative cash flows from operations. As of September 30, 2026, the Company had an accumulated deficit of $794.9 million and cash, cash equivalents, and investments of $624.7 million. For the nine months ended September 30, 2026, the Company had a net loss of $337.7 million and net cash used in operating activities of $115.1 million.
Since inception, the Company has funded its operations by raising aggregate gross proceeds of approximately $1.4 billion from sales of common stock, convertible preferred stock, pre-funded warrants, and convertible notes, as well as borrowings under the Loan Agreement (as defined and further described in Note 6, “Senior Secured Term Loan”). The Company has a limited operating history, and the sales and income potential of its business is unproven. The Company expects to continue to incur substantial losses for the foreseeable future as a result of its research and development and other activities until such time, if ever, that it begins generating substantial revenue from product sales. Additional funding may be required to continue with the Company’s future research and development and commercial launch activities. The Company expects to finance its operations through equity offerings, debt financings, and other capital sources, including potential strategic collaborations, licensing, and other similar arrangements. The Company believes that its cash, cash equivalents, and investments as of September 30, 2026 will be sufficient to allow the Company to fund its planned operations, including the commercial launch of lorundrostat, for at least twelve months from the issuance date of these condensed financial statements.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) and applicable rules and regulations of the U.S. Securities and Exchange Commission (the SEC) for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial information normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These condensed financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all normal recurring adjustments considered necessary for a fair presentation of the Company’s financial information. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and related notes in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.
Any reference in these notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) of the Financial Accounting Standards Board (FASB).
Reclassifications
Certain comparative figures in the other income and expense lines of the prior period condensed statements of operations have been reclassified to conform to the current period presentation. These reclassifications had no impact on the previously reported net loss.
Segment Information
The Company operates inone operating segment for the purposes of assessing performance, making operating decisions, and allocating Company resources. The Company’s chief operating decision maker (CODM) is its chief executive officer. The CODM considers net loss to evaluate overall expenses associated with the Company’s activities, including the progress of ongoing clinical trials, the planning and execution of current and future research and development, commercial-readiness, and other activities. Further, the CODM reviews and utilizes functional expenses (research and development and general and administrative) as reported in the statements of operations to manage the Company’s operations. Other segment items included in net loss are interest income, net and other income (expense). These measures of performance, significant expenses, and other items are each reflected in the condensed statements of operations. The accounting policies of the segment are the same as those described below. The measure of segment assets is reported on the condensed balance sheets as total assets. All assets are held in the United States.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of income and expenses during the reporting period. Actual results could differ from those estimates. Estimates have been used in the following areas, among others: research and development accruals and income taxes.
Cash and Cash Equivalents
All highly liquid investments that have maturities of 90 days or less at the date of purchase are classified as cash equivalents. The Company’s cash and cash equivalents balances as of September 30, 2026 and December 31, 2025 include cash balances and amounts held primarily in interest-bearing money market accounts and U.S. Treasury bills. As of September 30, 2026 and December 31, 2025, the Company didnot have any restricted cash balances. The following table provides a reconciliation of cash and cash equivalents as reported in the condensed statements of cash flows to the condensed balance sheets (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2026 | 2025 | |
| Cash | $1,106 | $1,030 |
| Cash equivalents | 100,167 | 171,891 |
| Total cash and cash equivalents | $101,273 | $172,921 |
Concentration of Credit Risk
The Company has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other hedging arrangements. Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash balances in multiple accounts with several financial institutions that, from time to time, are in excess of federally insured limits.
Fair Value Measurements
The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. ASC Topic 820, Fair Value Measurement, establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available.
Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value and is not a measure of the investment credit quality. The three levels of the fair value hierarchy are described below:
Level 1 – quoted prices in active markets for identical assets and liabilities
Level 2 – other significant observable inputs (including quoted prices for similar assets and liabilities, interest rates, credit risk, etc.)
Level 3 – significant unobservable inputs (including the Company’s own assumptions in determining the fair value of assets and liabilities)
For certain financial instruments, including cash and cash equivalents, prepaid expenses, accounts payable, and certain accrued liabilities, the recorded amount approximates estimated fair value due to their relatively short maturity period. Refer to Note 3, “Fair Value of Financial Instruments” for additional details of the Company’s financial instruments.
Investments
The Company generally invests its excess cash in money market funds and investment-grade short- and long-term fixed-income debt securities, such as U.S. Treasury bills. Such investments are included in cash and cash equivalents and investments in the condensed balance sheets. The Company determines the appropriate classification of securities at the time of purchase and re-evaluates such designation as of each balance sheet date. Securities are classified as held-to-maturity when the Company has the positive intent and ability to hold the securities to maturity. Held-to-maturity securities are carried at amortized cost, adjusted for the accretion of discounts using the interest method.
The Company invested in marketable securities during the nine months ended September 30, 2026 and 2025, and no impairment charges were recorded. For held-to-maturity investments, the Company periodically reviews each individual security position that has an unrealized loss, or impairment, to determine if that impairment is other-than-temporary. If the Company believes an impairment of a security position is other than temporary, based on available quantitative and qualitative information as of the report date, the loss will be recognized within total other income, net in the Company’s condensed statements of operations, and a new cost basis in the investment will be established.
Deferred Offering Costs
The Company capitalizes certain legal, professional, accounting, and other third-party fees that are directly associated with in-process equity issuances as deferred offering costs until such equity issuances are consummated. After consummation of the equity issuance, these costs are recorded as a reduction of the proceeds from the equity issuance. Should the equity issuance be abandoned, the deferred offering costs are expensed immediately as a charge to operating expenses in the condensed statements of operations. Deferred offering costs as of each of September 30, 2026 and December 31, 2025 were $0.2 million. Such costs are classified in other assets on the condensed balance sheets.
Debt Discounts, Debt Premiums, and Debt Issuance Costs
The Company records debt obligations at their outstanding principal amount, adjusted for any unamortized debt discounts, debt premiums, and debt issuance costs. Debt discounts and debt issuance costs are presented as reductions of the carrying amount of the related debt liability while debt premiums are presented as increases to the carrying amount of the related debt liability.
Debt discounts, debt premiums, and debt issuance costs allocated to drawn tranches are amortized to interest expense using the effective interest method over the applicable maturity period of the related debt. Debt issuance costs allocated to undrawn, committed tranches are amortized to interest expense on a straight-line basis over the period that the related borrowing capacity is available, which the Company believes approximates the effective interest method. Debt issuance costs allocated to undrawn, committed tranches are recorded as a deferred asset (rather than as a direct reduction of the carrying amount of outstanding debt) until the applicable tranche is drawn, at which point the remaining unamortized balance attributable to that tranche is reclassified and presented as a reduction of the carrying amount of the related debt.
Costs incurred in connection with obtaining financing are capitalized and amortized over the expected life of the related borrowing. Upon the repayment, extinguishment, or modification of debt, any remaining unamortized debt discounts, debt premiums, and debt issuance costs associated with the debt are recognized in earnings. However, in the case of a modification of debt (as opposed to a repayment or extinguishment), any remaining unamortized debt discounts, debt premiums, and debt issuance costs associated with the debt are instead amortized over the updated expected life of the revised debt, rather than recognized in earnings immediately.
As of September 30, 2026, the unamortized debt discounts and debt issuance costs were approximately $1.6 million and $0.4 million, respectively, which were included within senior secured term loan, net of current portion on the Company’s condensed balance sheets. Accretion of the debt premium recognized through September 30, 2026 was immaterial to the condensed financial statements.
Stock-Based Compensation
The Company accounts for its stock-based compensation awards in accordance with ASC Topic 718, Compensation – Stock Compensation (ASC 718). ASC 718 requires share-based payment arrangements to be recognized in the condensed statements of operations based on their grant date fair values. The Company’s stock-based awards are subject only to service-based vesting conditions. The Company measures restricted common stock awards using the difference, if any, between the purchase price per share of the award and the fair value of the Company’s common stock at the date of the grant or modification. Restricted stock unit awards are measured at the grant date fair value based on the closing price of the Company’s common stock on the date of the grant. The Company estimates the fair value of its stock option awards using the Black-Scholes option pricing model, which requires the input of assumptions, including (i) the expected stock price volatility, (ii) the calculation of the expected term of the award, (iii) the risk-free interest rate, and (iv) expected dividends.
Volatility — Due to the Company’s limited operating history and a lack of company-specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar publicly traded companies. The Company believes that the companies in the group were most representative of the Company and had characteristics similar to its own, including stage of product development, a focus on the life sciences industry, and other economic and industry characteristics.
Expected Term — The Company uses the simplified method to estimate the expected term, as it does not have sufficient historical exercise data to provide a reasonable basis for otherwise estimating the expected term.
Risk-Free Interest Rate— The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected life of the stock options.
Expected Dividends— To date, the Company has not issued any dividends and does not expect to issue dividends over the life of the options and therefore has estimated the dividend yield to be zero.
Subsequent to the closing of the Company’s initial public offering of its common stock in February 2023, the Company determines the fair market value of its common stock using the closing price of its common stock as reported on the Nasdaq Global Select Market.
Compensation expense related to time-based awards, including restricted stock units, is recognized on a straight-line basis by recognizing the grant date fair value over the requisite service period, which is generally the vesting term. Management evaluates its award grants and modifications and will adjust the fair value if any are determined to be spring-loaded. The Company accounts for forfeitures as they occur.
Net Loss Per Share
The Company’s basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding for the period. The diluted net loss per share attributable to common stockholders is computed by giving effect to all potential common stock equivalents outstanding for the period, determined using the treasury stock method. For purposes of this calculation, unvested restricted stock awards, restricted stock units, and stock options to purchase common stock are considered to be common stock equivalents but have been excluded from the calculation of diluted net loss per share attributable to common stockholders as their effect is anti-dilutive. The weighted-average number of common shares used in the basic and diluted net loss per share attributable to common stockholders calculations includes the weighted-average pre-funded warrants outstanding during the period, as they are exercisable at any time for nominal cash consideration. The following table sets forth the potential common shares excluded from the calculation of net loss per share attributable to common stockholders because their inclusion would be anti-dilutive:
| Nine Months Ended | ||
|---|---|---|
| September 30, | ||
| 2026 | 2025 | |
| Outstanding stock options | 7,494,869 | 6,612,340 |
| Unvested restricted stock units | 1,353,753 | — |
| Unvested restricted stock awards | — | 186,872 |
| Total | 8,848,622 | 6,799,212 |
Recently Issued Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard-setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.
In November 2024, the FASB issued ASU 2024-03, Income Statement — Reporting Comprehensive Income — Expense Disaggregation Disclosures (Subtopic 220-40), as clarified by ASU 2025-01, which requires disaggregated disclosure of certain expense categories. The guidance is effective for the Company’s annual disclosures for fiscal year 2027 and interim periods thereafter, and may be adopted on a prospective or retrospective basis with early adoption permitted. The Company is evaluating the impact of the guidance on its disclosures. While the Company expects that additional disaggregated disclosures will be required upon adoption, the guidance will not affect the recognition or measurement of expenses.
Note 3. Fair Value of Financial Instruments
The following table presents financial instruments measured at fair value on a recurring basis based on the fair value hierarchy (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2026 | 2025 | |
| Level 1 | ||
| Money market funds (included in cash and cash equivalents) | $100,167 | $161,943 |
The following methods and assumptions were used by the Company in estimating the fair values of each class of financial instrument disclosed herein:
Money Market Funds — The carrying amounts of money market funds approximate their fair values due to their short-term nature and are measured with Level 1 inputs utilizing quoted prices (unadjusted) in active markets for identical assets.
U.S. Treasury Bills — The fair values of these securities are determined using Level 2 inputs utilizing quoted prices (unadjusted) in active markets for similar assets.
There were no transfers within the fair value hierarchy during the periods presented.
The following tables present information about the Company’s held-to-maturity U.S. Treasury bills (in thousands):
| Balance Sheet Location | Original Maturities | AmortizedCost | EstimatedFair Value |
|---|---|---|---|
| Investments | between 3 and 12 months | $523,399 | $523,129 |
| Balance Sheet Location | Original Maturities | AmortizedCost | EstimatedFair Value |
|---|---|---|---|
| Cash and cash equivalents | less than 3 months | $9,948 | $9,948 |
| Investments | between 3 and 12 months | 483,714 | 483,891 |
| Total | $493,662 | $493,839 |
Note 4. Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2026 | 2025 | |
| Research and development expenses | $8,842 | $3,460 |
| Compensation and benefits | 6,868 | 5,540 |
| Professional fees and other | 11,627 | 4,096 |
| Total | $27,337 | $13,096 |
Note 5. Commitments and Contingencies
Tanabe License Agreement
In July 2020, the Company entered into an exclusive license agreement (as amended, the Tanabe License) with Tanabe Pharma Corporation (Tanabe) (formerly Mitsubishi Tanabe Pharma Corporation), pursuant to which Tanabe granted the Company an exclusive, worldwide, royalty-bearing, sublicensable license under Tanabe’s patent and other intellectual property rights to exploit products incorporating lorundrostat (formerly MT-4129) (Lorundrostat Product) for the prevention, treatment, diagnosis, detection, monitoring, or predisposition testing with respect to indications, diseases, and conditions in humans. Pursuant to the Tanabe License, the Company previously paid Tanabe a $1.0 million upfront fee and development milestone payments of $9.0 million in the aggregate.
On June 2, 2026, the Company entered into a fourth amendment to the Tanabe License (the Fourth Amendment), pursuant to which the Company’s obligation to pay Tanabe royalties on net sales of Lorundrostat Products was terminated, the license was amended and restated to grant the Company an exclusive, worldwide, royalty-free, sublicensable, perpetual, irrevocable license, and the Company’s diligence obligations with respect to the ongoing development and commercialization of lorundrostat were eliminated. As consideration, the Company made an upfront cash payment to Tanabe of $200.0 million and agreed to pay additional commercial milestone payments of up to $100.0 million in the aggregate (the New Milestones). As a result of the Fourth Amendment, the Company has remaining obligations to pay Tanabe commercial milestone payments, including the New Milestones, of up to $255.0 million in the aggregate upon first commercial sale and upon meeting certain annual sales targets, as well as up to $10.0 million related to commercialization for a potential second indication.
The New Milestones become immediately due and payable by the Company upon certain change-of-control transactions. Within a specified period following execution of the Fourth Amendment, the parties agreed to enter into an agreement to terminate the Tanabe License, pursuant to which, among other things, Tanabe would assign to the Company all of Tanabe’s rights in the licensed intellectual property.
Subsequent to September 30, 2026, on October 27, 2026, the Company and Tanabe entered into a Termination Agreement pursuant to which the Tanabe License was terminated and Tanabe assigned to the Company all of Tanabe’s rights in the licensed intellectual property. Also on October 27, 2026, the Company and Tanabe entered into a Payment Obligation Agreement pursuant to which, notwithstanding the termination of the Tanabe License, the Company remains obligated to pay Tanabe the commercial milestone payments described above, including the New Milestones. In addition, the right of first negotiation previously granted to Tanabe with respect to any license of rights to lorundrostat continues solely with respect to Japan for so long as any milestone payments remain outstanding. The termination of the Tanabe License did not result in any material early termination penalties.
During the nine months ended September 30, 2026, the Company recognized the $200.0 million upfront cash payment as research and development expense in its condensed statements of operations because lorundrostat has not received regulatory approval and the related intellectual property has no alternative future use. The Company hasno remaining development milestone payment obligations under the Tanabe License. As of September 30, 2026, no commercial milestone payments had been made under the Tanabe License. The commercial milestone payments, including the New Milestones, are contingent upon the achievement of specified future events and will be recognized when the related contingencies are resolved.
Office Lease Agreement
On September 3, 2026, the Company entered into a lease agreement to lease approximately 13,135 square feet of office space in Radnor, Pennsylvania (the Radnor Lease). The Radnor Lease has an initial lease term of 60 months. The Company currently anticipates lease commencement in the fourth quarter of 2026; however, the exact commencement date remains subject to completion of the landlord’s improvements and delivery of the premises. Aggregate base rent over the initial lease term, net of contractual rent abatement, is approximately $1.7 million. In addition to base rent, the Company is required to pay common area charges and other operating expenses.
Litigation
Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. From time to time, the Company may become involved in legal proceedings arising in the ordinary course of business. The Company was not subject to any material legal proceedings during the three and nine months ended September 30, 2026 and 2025, and no material legal proceedings are currently pending or threatened.
Indemnification Agreements
In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising from breach of such agreements or intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with officers of the Company and members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as officers or directors. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not aware of any claims under indemnification arrangements, and it has not accrued any material liabilities related to such obligations in its condensed financial statements as of September 30, 2026 and December 31, 2025.
Note 6. Senior Secured Term Loan
On June 2, 2026, the Company entered into a senior secured term loan agreement (the Loan Agreement) with BioPharma Credit PLC, as collateral agent, and each of BPCR Limited Partnership and BioPharma Credit Investments V (Master) LP, which are funds managed by Pharmakon Advisors, LP, as lenders. The Loan Agreement provides for afive‑year senior secured term loan of up to $500.0 million, maturing on June 3, 2031 (the Maturity Date), consisting of the following tranches (collectively, the Term Loans): (i) a Tranche A Loan of $100.0 million, which was drawn on June 2, 2026; (ii) a Tranche B Loan of $150.0 million, which is required to be drawn no later than April 30, 2027, subject to approval by the FDA of the lorundrostat NDA (the Tranche B Approval Condition); (iii) a Tranche C Loan of $150.0 million, which is available at the Company’s election until December 14, 2028, subject to the occurrence of the Tranche B Approval Condition and the achievement of certain net sales milestones; and (iv) a Tranche D Loan of $100.0 million, which is available at the Company’s election until June 14, 2029, subject to the draw of the Tranche C Loan and the achievement of certain net sales milestones. As of September 30, 2026, the Company had drawn the $100.0 million Tranche A Loan, and the Tranche B Loan, Tranche C Loan, and Tranche D Loan were undrawn. The Maturity Date is subject to acceleration to June 30, 2028 if the Tranche B Approval Condition is not satisfied on or before September 30, 2027.
The Term Loans bear interest at a rate per annum equal to the three‑month secured overnight financing rate (subject to a 3.25% floor) plus 5.50%, payable quarterly in arrears. At inception of the Tranche A Loan, the applicable interest rate was 9.16%. The Company is required to pay a funding fee equal to 2.00% of the funding amount on the funding date of each Term Loan, and paid a funding fee of $2.0 million in connection with the Tranche A Loan. The Company may elect to prepay the Term Loans in whole or, subject to certain conditions, in part prior to the Maturity Date, subject to certain prepayment, make‑whole, and exit fees. The Term Loans are subject to certain mandatory prepayments, including a repayment of all Term Loans infour equal installments commencing on September 30, 2027 to the extent the Tranche B Approval Condition is not met on or prior to September 30, 2027. Each Term Loan requires the Company to pay a final fee equal to 1.5% of the original principal amount of such Term Loan (the Final Fee), due upon the earlier of the Maturity Date or prepayment of the applicable Term Loan. The Final Fee associated with the Tranche A Loan is fixed at $1.5 million and will not increase. However, the aggregate Final Fee payable under the Loan Agreement will increase if additional Term Loan tranches are drawn, as each additional tranche would be subject to its own Final Fee.
Borrowings under the Term Loans are secured by substantially all of the Company’s assets, subject to certain exceptions.
The Loan Agreement contains financial covenants, including a minimum liquidity requirement and, with respect to the fiscal year ending December 31, 2028 and then tested quarterly commencing with the fiscal quarter ending March 31, 2029, a minimum trailing twelve-month consolidated net product revenue covenant. As of September 30, 2026, the Company was in compliance with all covenants under the Loan Agreement.
Upon the occurrence of an event of default under the Loan Agreement, the lenders may, among other things, accelerate the Company’s obligations under the Loan Agreement, and upon an event of default relating to certain insolvency, liquidation, bankruptcy, or similar events, all outstanding obligations under the Loan Agreement will be automatically accelerated.
The components of the Term Loan consisted of the following (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2026 | 2025 | |
| Principal - Term Loan | $100,000 | $— |
| Less: unamortized debt discount and debt issuance costs, net of accreted Final Fee | (1,727) | — |
| Carrying amount of Term Loan (1) | $98,273 | $— |
| Less: current portion | (25,000) | — |
| Term Loan, net of current portion | $73,273 | $— |
(1)The carrying value of the outstanding liability, which bears a variable interest rate indexed to thethree-month secured overnight financing rate (subject to a 3.25% floor) plus 5.50%, approximates fair value, as it reprices when market interest rates change and represents a Level 2 measurement within the fair value hierarchy.
In connection with the Tranche A Loan, the Company received gross proceeds of $100.0 million. The Company recognized a debt discount of $2.0 million and incurred $2.1 million in debt issuance costs, which were comprised of amounts paid to third parties and lenders. The Company allocated a portion of the debt issuance costs to the undrawn future Term Loans and recognized a long-term deferred asset in the amount of $1.7 million, which is being amortized to interest expense on a straight-line basis over the applicable maturity period to which the related borrowing capacity is available. As of September 30, 2026, the unamortized debt discounts and debt issuance costs of approximately $1.6 million and $0.4 million, respectively, were recorded as a reduction of the carrying amount of the Tranche A Loan and are being amortized to interest expense over the applicable maturity period of the Tranche A Loan using the effective interest method. The effective interest rate on the Tranche A Loan was 11.38% as of September 30, 2026.
During the three and nine months ended September 30, 2026, the Company recognized interest expense of approximately $3.2 million and $4.0 million, respectively, related to the Term Loans, consisting of contractual interest, amortization of the debt discount and debt issuance costs, and amortization of the Final Fee. Interest expense is recorded in the condensed statements of operations within interest income, net. The Company didnot recognize any interest expense for the three and nine months ended September 30, 2025.
As of September 30, 2026, four equal quarterly principal payments of approximately $25.0 million each are required beginning on September 30, 2030. Although no principal payments are scheduled within twelve months of September 30, 2026, the Company classified a portion of the carrying amount of the Term Loans as a current portion of long-term debt because mandatory repayments would commence on September 30, 2027 if the Tranche B Approval Condition is not satisfied on or before that date. If the Tranche B Approval Condition is not satisfied on or before September 30, 2027, future principal payments due under the Term Loans, excluding unamortized debt issuance costs, would be as follows (in thousands):
| Year ending December 31, | Amount |
|---|---|
| 2026 (remainder) | $— |
| 2027 | 50,000 |
| 2028 | 50,000 |
| Total | $100,000 |
Interest payments commenced on September 30, 2026, and the Company paid approximately $3.1 million of interest during the three months ended September 30, 2026.
Note 7. Capital Stock
As of September 30, 2026, the Company had reserved authorized shares of common stock for future issuance as follows:
| September 30, | |
|---|---|
| 2026 | |
| Common stock options outstanding | 7,494,869 |
| Shares available for grant under the ESPP | 2,054,364 |
| Shares available for grant under the 2023 Plan | 2,032,747 |
| Restricted stock units outstanding | 1,353,753 |
| Pre-funded warrants issued and outstanding | 549,755 |
| Shares available for grant under the 2025 Inducement Plan | 246,667 |
| Total | 13,732,155 |
Public Offering
On June 3, 2026, the Company entered into an underwriting agreement with BofA Securities, Inc., Goldman Sachs & Co. LLC, and Evercore Group L.L.C., relating to the issuance and sale of 5,660,378 shares of the Company’s common stock at a price of $26.50 per share for net proceeds of approximately $143.6 million after deducting underwriting discounts and offering expenses. The offering was made pursuant to the Company’s shelf registration statement on Form S-3 (Registration Statement No. 333-291435), filed with the SEC on November 10, 2025, and a prospectus supplement and accompanying prospectus filed with the SEC on June 3, 2026. The Company used the net proceeds from the offering to fund a portion of the $200.0 million upfront payment made on June 2, 2026 to Tanabe upon execution of the Fourth Amendment (as further described in Note 5, “Commitments and Contingencies”).
At-the-Market Equity Offering Sales Agreements
On November 10, 2025, the Company entered into an ATM Equity Offering Sales Agreement (the ATM Agreement) with BofA Securities, Inc., Evercore Group L.L.C., and Goldman Sachs & Co. LLC, pursuant to which the Company may sell shares of its common stock having an aggregate offering price of up to $300.0 million from time to time. During the nine months ended September 30, 2026, the Company sold an aggregate of 568,320 shares of common stock pursuant to the ATM Agreement at a weighted-average price of $35.66 per share for aggregate net proceeds of approximately $20.2 million after deducting commissions and offering expenses. No shares of common stock were sold pursuant to the ATM Agreement during the nine months ended September 30, 2025. From inception of the ATM Agreement and through September 30, 2026, the Company sold an aggregate of 2,720,508 shares of common stock at a weighted-average price of $41.45 per share for aggregate net proceeds of approximately $112.4 million after deducting commissions and offering expenses. As of September 30, 2026, shares of common stock having an aggregate offering price of approximately $187.2 million remained available for sale pursuant to the ATM Agreement.
On March 21, 2024, the Company entered into an ATM Equity Offering Sales Agreement (the Prior ATM Agreement) with BofA Securities, Inc. and Evercore Group L.L.C. Effective November 9, 2025, the Prior ATM Agreement was terminated in connection with the Company entering into the ATM Agreement. There wereno sales of common stock pursuant to the Prior ATM Agreement during the nine months ended September 30, 2026. During the nine months ended September 30, 2025, the Company sold an aggregate of 1,914,040 shares of common stock pursuant to the Prior ATM Agreement at a weighted-average price of $14.32 per share for aggregate net proceeds of approximately $27.3 million after deducting commissions and offering expenses. No additional shares of common stock were sold pursuant to the Prior ATM Agreement following September 30, 2025.
Note 8. Stock-Based Compensation
2023 Incentive Award Plan
The Company grants equity awards under the 2023 Incentive Award Plan (the 2023 Plan). During the nine months ended September 30, 2026, the Company began granting restricted stock units under the 2023 Plan.
2025 Employment Inducement Incentive Award Plan
The Company maintains the 2025 Employment Inducement Incentive Award Plan (the 2025 Inducement Plan), under which non‑qualified stock options and restricted stock units may be granted in connection with the commencement of employment. During the nine months ended September 30, 2026, the Company began granting restricted stock units under the 2025 Inducement Plan.
2020 Equity Incentive Plan
The 2020 Equity Incentive Plan (the 2020 Plan) continues to govern the terms of outstanding awards, although no new awards are granted under the plan.
The following table summarizes the Company’s awards outstanding and shares available for grant as of September 30, 2026:
| OptionsOutstanding | UnvestedRestricted Stock Units | Shares Availablefor Grant | |
|---|---|---|---|
| 2023 Plan | 6,841,527 | 1,030,010 | 2,032,747 |
| 2025 Inducement Plan | 429,590 | 323,743 | 246,667 |
| 2020 Plan | 223,752 | — | — |
| Total | 7,494,869 | 1,353,753 | 2,279,414 |
2023 Employee Stock Purchase Plan
The Company maintains the 2023 Employee Stock Purchase Plan (the ESPP) under which eligible employees may purchase shares of common stock through payroll deductions. As of September 30, 2026, the Company had 2,054,364 shares available for issuance, and 70,559 cumulative shares had been issued under the ESPP.
Total stock-based compensation expense recognized was allocated as follows (in thousands):
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2026 | 2025 | 2026 | 2025 | |
| Research and development | $2,666 | $3,154 | $7,352 | $6,725 |
| General and administrative | 5,214 | 2,687 | 14,431 | 7,314 |
| Total | $7,880 | $5,841 | $21,783 | $14,039 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.