Edgewise Therapeutics, Inc. 10-Q

Item 1. Financial Statements EDGEWISE THERAPEUTICS, INC. Condensed Balance Sheets (In thousands, except share and per share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ As of ​ As of ​ ​ June 30, ​ December 31, ​ 2025 2024 Assets ​ (unaudited) ​ ​ Current assets ​ ​ ​ Cash and cash equivalents ​ $ 43,404 $ 41,666 Marketable securities, available for sale ​ 550,588 ​ 428,504 Prepaid expenses and other assets ​ 9,263 ​ 5,313 Total current assets ​ 603,255 ​ 475,483 ​ ​ ​ ​ ​ ​ ​ Property and equipment, net ​ 8,595 ​ 9,503 Operating lease right-of-use asset ​ ​ 1,484 ​ ​ 1,569 Other non-current assets ​ — ​ 262 ​ ​ ​ ​ ​ ​ ​ Total assets ​ $ 613,334 ​ $ 486,817 ​ ​ ​ ​ ​ ​ ​ Liabilities and stockholders' equity ​ ​ ​ ​ ​ ​ ​ ​ ​ Current liabilities ​ ​ ​ Accounts payable ​ $ 8,320 ​ $ 5,579 Accrued compensation ​ 5,636 ​ 10,056 Accrued other expenses ​ 5,936 ​ 7,229 Operating lease liability, current portion ​ ​ 1,004 ​ ​ 996 Total current liabilities ​ 20,896 ​ 23,860 Operating lease liability, net of current portion ​ ​ 3,367 ​ ​ 3,741 ​ ​ ​ ​ ​ ​ ​ Total liabilities ​ 24,263 ​ 27,601 ​ ​ ​ ​ ​ ​ ​ Commitments and contingencies (see note 5) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Stockholders' equity: ​ ​ Preferred stock, $ .0001 par value per share; 200,000,000 shares authorized and no shares issued or outstanding as of June 30, 2025 and December 31, 2024 ​ ​ — ​ ​ — Common stock, $ .0001 par value per share; 1,000,000,000 shares authorized as of June 30, 2025 and December 31, 2024; 105,341,296 shares and 94,838,466 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively ​ 10 ​ 9 Additional paid-in capital ​ 1,044,346 ​ 837,363 Accumulated other comprehensive income ​ ​ 204 ​ ​ 420 Accumulated deficit ​ ( 455,489 ) ​ ( 378,576 ) Total stockholders' equity ​ 589,071 ​ 459,216 ​ ​ ​ ​ ​ ​ ​ Total liabilities and stockholders' equity ​ $ 613,334 ​ $ 486,817 ​ The accompanying notes are an integral part of these condensed financial statements. 6 Table of Contents EDGEWISE THERAPEUTICS, INC. Condensed Statements of Operations and Comprehensive Loss (In thousands, except share and per share data) (Unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended June 30, ​ Six months ended June 30, ​ 2025 2024 2025 2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Operating expenses ​ ​ ​ ​ ​ ​ Research and development ​ $ 33,558 ​ $ 30,680 ​ $ 70,315 $ 58,374 General and administrative ​ 9,052 ​ 7,427 ​ 18,254 ​ 14,486 Total operating expenses ​ 42,610 ​ 38,107 ​ 88,569 ​ 72,860 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Loss from operations ​ ( 42,610 ) ​ ( 38,107 ) ​ ( 88,569 ) ​ ( 72,860 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Other income ​ ​ ​ ​ Interest income ​ 6,495 ​ 6,610 ​ 11,656 ​ 12,838 Total other income ​ 6,495 ​ 6,610 ​ 11,656 ​ 12,838 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Net loss ​ ​ ( 36,115 ) ​ ​ ( 31,497 ) ​ ​ ( 76,913 ) ​ ​ ( 60,022 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Other comprehensive income (loss): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Unrealized loss on available-for-sale securities ​ ​ ( 197 ) ​ ​ ( 193 ) ​ ​ ( 216 ) ​ ​ ( 1,153 ) Total comprehensive loss ​ $ ( 36,312 ) ​ $ ( 31,690 ) ​ $ ( 77,129 ) ​ $ ( 61,175 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Net loss per share, basic and diluted ​ $ ( 0.34 ) ​ $ ( 0.34 ) ​ $ ( 0.77 ) ​ $ ( 0.66 ) Weighted-average shares outstanding, basic and diluted ​ 104,940,493 ​ 93,515,356 ​ 100,062,373 ​ 90,541,332 ​ The accompanying notes are an integral part of these condensed financial statements. ​ ​ 7 Table of Contents ​ EDGEWISE THERAPEUTICS, INC. Condensed Statements of Stockholders’ Equity (In thousands, except share data) (Unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ Common Stock ​ Additional ​ Other Comprehensive ​ Accumulated ​ ​ ​ ​ Shares Amount Paid-In Capital Loss Deficit Total Balance as of December 31, 2023 70,453,342 ​ $ 7 ​ $ 563,487 ​ $ 99 ​ $ ( 244,763 ) ​ $ 318,830 Issuance of common stock, net of offering costs ​ 22,450,206 ​ ​ 2 ​ ​ 238,797 ​ ​ — ​ ​ — ​ ​ 238,799 Exercise of stock options 380,980 ​ — ​ 1,926 ​ ​ — ​ — ​ 1,926 Stock-based compensation — ​ — ​ 4,871 ​ ​ — ​ — ​ 4,871 Other comprehensive loss ​ — ​ — ​ — ​ ​ ( 960 ) ​ — ​ ( 960 ) Net loss ​ — ​ — ​ — ​ ​ — ​ ( 28,525 ) ​ ( 28,525 ) Balance as of March 31, 2024 93,284,528 ​ $ 9 ​ $ 809,081 ​ $ ( 861 ) ​ $ ( 273,288 ) ​ $ 534,941 Exercise of stock options and vesting of restricted stock ​ 283,039 ​ ​ — ​ ​ 1,577 ​ ​ — ​ ​ — ​ ​ 1,577 Purchase of common stock under Employee Stock Purchase Plan ​ 75,774 ​ ​ — ​ ​ 422 ​ ​ — ​ ​ — ​ ​ 422 Stock-based compensation ​ — ​ ​ — ​ ​ 5,224 ​ ​ — ​ ​ — ​ ​ 5,224 Other comprehensive loss ​ — ​ ​ — ​ ​ — ​ ​ ( 193 ) ​ ​ — ​ ​ ( 193 ) Net loss ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ ( 31,497 ) ​ ​ ( 31,497 ) Balance as of June 30, 2024 ​ 93,643,341 ​ $ 9 ​ $ 816,304 ​ $ ( 1,054 ) ​ $ ( 304,785 ) ​ $ 510,474 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ Common Stock ​ Additional ​ Other Comprehensive ​ Accumulated ​ ​ ​ ​ Shares Amount Paid-In Capital Income Deficit Total Balance as of December 31, 2024 ​ 94,838,466 ​ $ 9 ​ $ 837,363 ​ $ 420 ​ $ ( 378,576 ) ​ $ 459,216 Exercise of stock options 367,217 ​ — ​ 2,261 ​ ​ — ​ — ​ 2,261 Stock-based compensation — ​ — ​ 9,059 ​ ​ — ​ — ​ 9,059 Other comprehensive loss — ​ — ​ — ​ ​ ( 19 ) ​ — ​ ( 19 ) Net loss — ​ — ​ — ​ ​ — ​ ( 40,798 ) ​ ( 40,798 ) Balance as of March 31, 2025 95,205,683 ​ $ 9 ​ $ 848,683 ​ $ 401 ​ $ ( 419,374 ) ​ $ 429,719 Issuance of common stock, net of offering costs ​ 9,935,419 ​ ​ 1 ​ ​ 187,100 ​ ​ — ​ ​ — ​ ​ 187,101 Exercise of stock options and vesting of restricted stock ​ 151,535 ​ ​ — ​ ​ 233 ​ ​ — ​ ​ — ​ 233 Purchase of common stock under Employee Stock Purchase Plan ​ 48,659 ​ ​ — ​ ​ 597 ​ ​ — ​ ​ — ​ 597 Stock-based compensation ​ — ​ ​ — ​ ​ 7,733 ​ ​ — ​ ​ — ​ 7,733 Other comprehensive loss ​ — ​ ​ — ​ ​ — ​ ​ ( 197 ) ​ ​ — ​ ​ ( 197 ) Net loss ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ ( 36,115 ) ​ ( 36,115 ) Balance as of June 30, 2025 ​ 105,341,296 ​ $ 10 ​ $ 1,044,346 ​ $ 204 ​ $ ( 455,489 ) ​ $ 589,071 ​ The accompanying notes are an integral part of these condensed financial statements. ​ 8 Table of Contents EDGEWISE THERAPEUTICS, INC. Condensed Statements of Cash Flows (In thousands) (Unaudited) ​ ​ ​ ​ ​ ​ ​ ​ ​ Six months ended June 30, ​ 2025 2024 Cash flows from operating activities ​ ​ ​ ​ ​ Net loss ​ $ ( 76,913 ) $ ( 60,022 ) Adjustments to reconcile net loss to net cash used in operating activities: ​ ​ ​ Depreciation ​ ​ 1,036 ​ 953 Stock-based compensation ​ 16,792 ​ 10,095 Accretion of discount on marketable securities, net ​ ​ ( 4,126 ) ​ ​ ( 6,703 ) Amortization of right-of-use asset ​ ​ 85 ​ ​ 106 Changes in assets and liabilities: ​ ​ ​ Prepaid expenses and other assets ​ ( 3,950 ) ​ 914 Accounts payable ​ 2,707 ​ 2,673 Accrued compensation ​ ( 4,420 ) ​ ( 1,451 ) Accrued other expenses and other liabilities ​ ( 1,293 ) ​ ( 927 ) Lease liability ​ ( 366 ) ​ ​ ( 335 ) Net cash used in operating activities ​ ( 70,448 ) ​ ​ ( 54,697 ) ​ ​ ​ ​ ​ ​ ​ Cash flows from investing activities ​ ​ ​ ​ Purchases of marketable securities ​ ( 385,942 ) ​ ( 368,558 ) Sales of marketable securities ​ ​ 38,650 ​ ​ 1,759 Maturities of marketable securities ​ ​ 229,118 ​ ​ 136,377 Purchases of property and equipment ​ ( 94 ) ​ ( 518 ) Net cash used in investing activities ​ ( 118,268 ) ​ ( 230,940 ) ​ ​ ​ ​ ​ ​ ​ Cash flows from financing activities ​ ​ Proceeds from issuance of common stock, net of offering costs ​ ​ 187,362 ​ ​ 239,147 Exercise of stock options ​ 2,494 ​ 3,503 Payment of deferred offering costs ​ ​ — ​ ​ ( 48 ) Proceeds from Employee Stock Purchase Plan ​ ​ 598 ​ ​ 423 Net cash provided by financing activities ​ 190,454 ​ 243,025 ​ ​ ​ ​ ​ ​ ​ Net change in cash and cash equivalents ​ 1,738 ​ ( 42,612 ) Cash and cash equivalents at beginning of period ​ 41,666 ​ 86,097 Cash and cash equivalents at end of period ​ $ 43,404 ​ $ 43,485 Supplemental disclosures of non-cash investing and financing activities: ​ ​ Property and equipment purchases included in accounts payable ​ $ 78 ​ $ 116 Deferred offering costs included in accounts payable and accrued other expenses ​ $ — ​ $ 214 ​ The accompanying notes are an integral part of these condensed financial statements. 9 Table of Contents EDGEWISE THERAPEUTICS, INC. Notes to Condensed Financial Statements (Unaudited) NOTE 1 DESCRIPTION OF BUSINESS Organization and Description of Business Edgewise Therapeutics, Inc. (the Company) was incorporated as a Delaware corporation in May 2017, and it is headquartered in Boulder, Colorado. The Company is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe muscle diseases for which there is significant unmet medical need. The Company’s lead product candidates are sevasemten and EDG-7500. Sevasemten is an orally administered small molecule designed to address the root cause of dystrophinopathies including Duchenne muscular dystrophy (Duchenne) and Becker muscular dystrophy (Becker). The Company is currently studying sevasemten in Phase 2 trials, which are being held in the U.S. and Israel and in certain countries in Europe and Australasia. The Company is enrolling a multipart Phase 2 trial with EDG-7500, for the potential treatment of hypertrophic cardiomyopathy (HCM). The Company is using its proprietary drug discovery platform to develop a pipeline of precision medicine product candidates that target key muscle proteins and modulators to address a broad array of serious muscle disorders. Risks and Uncertainties The board of directors of the Company discusses with management macroeconomic and geopolitical developments, including inflation, instability in the banking and financial services sector, tightening of the credit markets, the impact of changes in the U.S. government administration and policy positions, international conflicts, public health pandemics, cybersecurity, sanctions, and changes in tariffs so that the Company can be prepared to react to new developments as they arise. The board of directors and the management of the Company are carefully monitoring these developments and the resulting economic impact on its financial condition and results of operations. ​ Liquidity and Capital Resources The Company has an accumulated deficit of $ 455.5 million and cash, cash equivalents and marketable securities of $ 594.0 million as of June 30, 2025. The Company’s ability to fund ongoing operations is highly dependent upon raising additional capital through the issuance of equity securities and issuing debt or other financing vehicles. On June 16, 2023, the Company entered into a Sales Agreement (Sales Agreement) with BofA Securities, Inc. (BofA Securities) under which the Company could offer and sell shares of common stock, having aggregate sales proceeds of up to $ 125.0 million from time to time, through an “at the market offering” program (ATM Program) under which BofA Securities acted as sales agent. Effective January 19, 2024, the Company suspended and terminated the prospectus related to the Company’s common stock issuable pursuant to the terms of the Sales Agreement (the ATM Prospectus). As of the date of the suspension of the ATM Prospectus, the Company had sold 7,560,068 shares of our common stock at a weighted average price of $ 7.93 per share. The gross proceeds were $ 59.9 million, and the net proceeds were $ 59.4 million, after deducting underwriting discounts and commissions of $ 0.2 million and offering expenses of $ 0.3 million. On January 23, 2024, the Company closed an underwritten registered direct offering of 21,818,182 shares of common stock at a public offering price of $ 11.00 per share (January 2024 Offering). The aggregate gross proceeds from the January 2024 Offering were $ 240.0 million, and the net proceeds were $ 231.9 million, after deducting underwriting discounts and commissions of $ 7.5 million and offering expenses of $ 0.6 million. On May 10, 2024, the Company filed an automatic shelf registration statement on Form S-3ASR that allows the Company to undertake various equity and debt offerings. Additionally, on May 10, 2024, the Company filed a prospectus supplement to the shelf registration statement and entered into a sales agreement with Leerink Partners LLC (Leerink Sales Agreement) under which the Company may offer and sell shares of common stock, having aggregate sales proceeds of up to $ 175.0 million from time to time, through an “at the market offering” program (Leerink ATM) 10 Table of Contents under which Leerink Partners LLC will act as sales agent. The Company has not yet offered or sold any shares of common stock related to the Leerink ATM. ​ On April 3, 2025, the Company closed an underwritten registered direct offering of 9,935,419 shares of common stock at a public offering price of $ 20.13 per share (April 2025 Offering). The aggregate gross proceeds from the April 2025 Offering were $ 200.0 million, and the net proceeds were $ 187.1 million, after deducting underwriting discounts and commissions of $ 12.0 million and offering expenses of $ 0.9 million. ​ The Company’s ability to secure capital is dependent upon success in developing its technology and product candidates. The Company cannot provide assurance that additional capital will be available on acceptable terms, if at all. The issuance of additional equity or debt securities will likely result in substantial dilution to the Company’s stockholders. Should additional capital not be available to the Company in the near term, or not be available on acceptable terms, the Company may be unable to realize value from the Company’s assets or discharge liabilities in the normal course of business, which may, among other alternatives, cause the Company to delay, substantially reduce, or discontinue operational activities to conserve cash balances, which could have a material adverse effect on the Company’s ability to achieve its intended business objectives. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. The Company believes that the $ 594.0 million of cash, cash equivalents and marketable securities on hand as of June 30, 2025 will be sufficient to fund its operations in the normal course of business and meet its liquidity needs through at least the next 12 months from the issuance of these financial statements. NOTE 2 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying condensed financial statements and related notes to the condensed financial statements should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 3, 2025. There have been no material changes to the summary of significant accounting policies as disclosed in that filing. These interim financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and include all adjustments consisting of normal recurring adjustments that management believes are necessary for a fair presentation of the periods presented and are not necessarily indicative of results expected for the full fiscal year or for any subsequent interim period. Marketable Securities, Available for Sale All marketable securities have been classified as “available-for-sale” and are carried at fair value, based upon quoted market prices. The Company considers its available-for-sale portfolio as available for use in current operations. Accordingly, the Company classifies its investments as short-term marketable securities, even though the stated maturity date may be one year or more beyond the current balance sheet date. Unrealized gains and losses, net of any related tax effects, are excluded from earnings and are included in other comprehensive income (loss) and reported as a separate component of stockholders’ equity until realized. Interest income, realized gains and losses, and declines in value judged to be other than temporary, if any, on available-for-sale securities are included in other income. The cost of securities sold is based on the specific-identification method. The amortized cost of securities is adjusted for amortization of premiums and accretion of discounts to maturity. In accordance with the Company’s investment policy, management invests in money market funds, corporate debt securities, commercial paper, asset-backed securities and government securities. The Company has not experienced any realized losses on its deposits of cash, cash equivalents, and marketable securities since inception. ​ 11 Table of Contents The following tables summarize the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ As of June 30, 2025 ​ ​ Fair Value ​ Amortized ​ Unrealized ​ Unrealized ​ Fair Market ​ Hierarchy Cost Basis Gains Losses Value Cash equivalents: ​ ​ ​ ​ Money market funds Level 1 ​ $ 43,218 ​ $ — ​ $ — ​ $ 43,218 Marketable securities, available for sale: ​ ​ ​ ​ ​ ​ Asset-backed securities Level 2 ​ 55,748 ​ ​ 31 ​ ​ — ​ 55,779 Corporate debt securities Level 2 ​ 183,498 ​ ​ 232 ​ ​ ( 24 ) ​ 183,706 Commercial paper Level 2 ​ 41,857 ​ ​ — ​ ​ ( 25 ) ​ 41,832 U.S. government treasury and agency securities ​ Level 2 ​ 269,281 ​ ​ 63 ​ ​ ( 73 ) ​ 269,271 Total ​ $ 593,602 ​ $ 326 ​ $ ( 122 ) ​ $ 593,806 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ As of December 31, 2024 ​ ​ Fair Value ​ Amortized ​ Unrealized ​ Unrealized ​ Fair Market ​ ​ Hierarchy Cost Basis Gains Losses Value Cash equivalents: ​ ​ ​ ​ Money market funds Level 1 ​ $ 41,474 ​ $ — ​ $ — ​ $ 41,474 Marketable securities, available for sale: ​ ​ ​ ​ ​ ​ Asset-backed securities Level 2 ​ 50,262 ​ 69 ​ — ​ 50,331 Corporate debt securities Level 2 ​ 193,769 ​ 179 ​ ( 81 ) ​ 193,867 Commercial paper ​ Level 2 ​ ​ 10,432 ​ ​ 3 ​ ​ — ​ ​ 10,435 U.S. government treasury and agency securities ​ Level 2 ​ ​ 173,621 ​ ​ 279 ​ ​ ( 29 ) ​ ​ 173,871 Total ​ $ 469,558 ​ $ 530 ​ $ ( 110 ) ​ $ 469,978 ​ The Company’s money market funds are classified as Level 1 because they are valued using quoted market prices. Investments in asset-backed securities, corporate debt securities, commercial paper and U.S. government treasury and agency securities, and supranational and sovereign government securities have been classified as Level 2 as they are valued using quoted prices in less active markets or other directly or indirectly observable inputs. Fair values of asset-backed securities, corporate debt securities, commercial paper, and U.S. government treasury and agency securities were derived based on input of market prices from multiple sources at each reporting period. With regard to commercial paper, all of the securities had high credit ratings and one year or less to maturity; therefore, fair value was derived from accretion of purchase price to face value over the term of maturity or quoted market prices for similar instruments if available. There were no transfers of financial assets between Level 1, Level 2, or Level 3, during the periods presented. As of June 30, 2025, the remaining contractual maturities of $ 457.4 million of marketable securities were less than one year and $ 93.0 million of marketable securities were between 1 and 2 years . The Company periodically reviews its portfolio of debt securities to determine if any investment is impaired due to credit loss or other potential valuation concerns. For debt securities where the fair value of the investment is less than the amortized cost basis, the Company has assessed at the individual security level for various quantitative factors including, but not limited to, the nature of the investments, changes in credit ratings, interest rate fluctuations, industry analyst reports, and the severity of impairment. Unrealized losses on marketable securities at June 30, 2025 were primarily due to changes in interest rates, including market credit spreads, and not due to increased credit risks associated with specific securities. ​ Accounting Standards Not Yet Adopted In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU is expected to enhance the transparency and decision usefulness of income tax disclosures by requiring public business entities on an annual basis to disclose specific categories in the rate reconciliation, additional 12 Table of Contents information for reconciling items that meet a quantitative threshold, and certain information about income taxes paid. This ASU is effective beginning with the Company’s 2025 fiscal year annual reporting period, with early adoption permitted. The Company is currently evaluating the impact that the adoption of this standard will have on its financial statements. In November 2024, the FASB issued ASU 2024-03, Income Statement–Reporting Comprehensive Income–Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This ASU is expected to improve the disclosures about a public business entity’s expenses and address requests from investors for more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation, amortization, and depletion) in commonly presented expense captions (such as cost of sales, selling, general, and administrative, and research and development). This ASU is effective beginning with the Company’s 2027 fiscal year annual reporting period and interim periods thereafter, with early adoption permitted. The Company is currently evaluating the impact that the adoption of this standard will have on its financial statements. ​ NOTE 3 PREFERRED STOCK AND COMMON STOCK The Company is authorized to issue two classes of stock designated as common stock and preferred stock. As of June 30, 2025, the total number of shares authorized was 1,200,000,000 . The total number of shares of common stock authorized was 1,000,000,000 . The total number of shares of preferred stock authorized was 200,000,000 . All shares of the Company’s capital stock have a par value of $ 0.0001 per share. Common stockholders are entitled to dividends if and when declared by the board of directors of the Company and after any convertible preferred share dividends are fully paid. The holder of each share of common stock is entitled to one vote. NOTE 4 STOCK-BASED COMPENSATION AWARDS Equity Incentive Plans In March 2021, the Company’s board of directors adopted, and its stockholders approved, the Company’s 2021 Equity Incentive Plan (2021 Plan), which became effective in March 2021 in connection with the IPO. Upon adoption of the 2021 Plan, the Company restricted the grant of future equity awards under its 2017 Equity Incentive Plan, as amended and restated (2017 Plan). The 2021 Plan provides for the grant of incentive stock options, within the meaning of Section 422 of the Internal Revenue Code, to the Company’s employees and any of its parent and subsidiary corporations’ employees, and for the grant of nonstatutory stock options, restricted stock, restricted stock units (RSUs), stock appreciation rights, performance units, and performance shares to its employees, directors, and consultants and its subsidiary corporations’ employees and consultants. The vesting of stock options is stated in each individual grant agreement, which is generally four years . Options granted expire 10 years after the date of grant. An RSU represents the right to receive one share of common stock upon vesting of the RSU. The fair value of each RSU is based on the closing price of the Company’s common stock on the date of grant and vest over 2 to 4 years . A total of 5,040,000 shares of the Company’s common stock were initially reserved for issuance pursuant to the 2021 Plan. The 2021 Plan share reserve increases by the number of shares under the 2017 Plan that are repurchased, forfeited, expired or cancelled after the effective date of the 2021 Plan up to the limit under the 2021 Plan. The number of shares available for issuance under the 2021 Plan increases annually on the first day of each fiscal year beginning with the Company’s 2022 fiscal year, equal to the least of (1) 5,040,000 shares, (2) five percent ( 5 %) of the outstanding shares of its common stock as of the last day of the immediately preceding fiscal year; or (3) such other amount as the Company’s board of directors may determine. As of June 30, 2025, there were 5,519,964 shares available for future issuance under the 2021 Plan. ​ ​ ​ 13 Table of Contents Inducement Equity Incentive Plan Effective August 10, 2024, the Company’s board of directors adopted the Company’s 2024 Inducement Equity Incentive Plan (Inducement Plan) and, subject to the adjustment provisions of the Inducement Plan, reserved 2,000,000 shares of the Company’s common stock for issuance pursuant to equity awards granted under the Inducement Plan. The Inducement Plan was adopted without stockholder approval pursuant to the applicable The Nasdaq Stock Market LLC’s (Nasdaq) Listing Rules. The Inducement Plan provides for the grant of equity-based awards, including nonstatutory stock options, stock appreciation rights, restricted stock, restricted stock units, and performance awards, and its terms are substantially similar to the 2021 Plan, including with respect to treatment of equity awards in the event of a “merger” or “change in control” as defined under the Inducement Plan, but with such other terms and conditions intended to comply with the Nasdaq inducement award exception or to comply with the Nasdaq acquisition and merger exception. In accordance with the Nasdaq Listing Rules, awards under the Inducement Plan may only be made to individuals not previously employees or non-employee directors of the Company (or following such individuals’ bona fide period of non-employment with the Company), as an inducement material to the individuals’ entry into employment with the Company, or, to the extent permitted by the Nasdaq Listing Rules, in connection with a merger or acquisition. As of June 30, 2025, there were 2,000,000 shares available for future issuance under the Inducement Plan. Founder Stock Options On September 19, 2017, the Company granted one of its founders the option to purchase 1,795,880 shares of the Company’s common stock at an exercise price of $ 0.18 per share which vested monthly over a four-year period and expire 15 years after the date of grant. This grant is separate from the Company’s equity incentive plans discussed above. As of June 30, 2025, 1,347,365 options were both outstanding and exercisable. 9,415 options were exercised during the six months ended June 30, 2025. 2021 Employee Stock Purchase Plan The 2021 Employee Stock Purchase Plan (2021 ESPP) enables eligible employees of the Company to purchase shares of common stock at a discount. A total of 504,000 shares of the Company’s common stock were initially reserved for issuance pursuant to the 2021 ESPP. The number of shares available for issuance under the 2021 ESPP increases annually on the first day of each fiscal year beginning with the Company’s 2022 fiscal year, equal to the least of (1) 1,008,000 shares, (2) one percent ( 1 %) of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year; or (3) such other amount as the Company’s board of directors may determine. As of June 30, 2025, the Company has reserved for issuance 2,927,132 shares of common stock pursuant to the 2021 ESPP. The 2021 ESPP provides for two offering periods of approximately twelve months’ duration, with purchase periods commencing on the first trading day on or after May 15 and November 15 and terminating on the last trading day on or before November 15 of the same year and May 15 of the following year, respectively. Contributions under the 2021 ESPP are limited to 15 % of an employee’s eligible compensation, IRS limitations, and a maximum of 6,000 shares of common stock during each offering period. 2021 ESPP participants will purchase shares of common stock at a price per share equal to 85 % of the lesser of (1) the fair market value per share of the common stock on the first trading day of the offering period or (2) the fair market value of the common stock on the purchase date. Total stock-based compensation expense related to all equity plans, including Founder Stock Options was allocated as follows (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended June 30, ​ Six months ended June 30, ​ 2025 2024 2025 2024 Research and development ​ $ 4,489 $ 2,924 $ 10,356 $ 5,624 General and administrative ​ 3,244 ​ 2,300 ​ 6,436 ​ 4,471 Total stock-based compensation expense ​ $ 7,733 ​ $ 5,224 ​ $ 16,792 ​ $ 10,095 ​ ​ 14 Table of Contents NOTE 5 COMMITMENTS AND CONTINGENCIES 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 six months ended June 30, 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 from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with 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 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 liabilities related to such obligations in its financial statements as of June 30, 2025. ​ NOTE 6 NET LOSS PER SHARE Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, common stock options and unvested restricted stock units are considered to be potentially dilutive securities. The Company’s participating securities do not have a contractual obligation to share in the Company’s losses. As such, the net loss was attributed entirely to common stockholders. As the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for those periods. The following table sets forth the computation of the basic and diluted net loss per share (in thousands, except share and per share data): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended June 30, ​ Six Months Ended June 30, ​ 2025 2024 2025 2024 Numerator ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Net loss ​ $ ( 36,115 ) ​ $ ( 31,497 ) ​ $ ( 76,913 ) $ ( 60,022 ) Denominator ​ ​ ​ ​ ​ ​ ​ ​ Weighted-average shares outstanding used in computing net loss per share, basic and diluted ​ ​ 104,940,493 ​ ​ 93,515,356 ​ ​ 100,062,373 ​ ​ 90,541,332 Net loss per share, basic and diluted ​ $ ( 0.34 ) ​ $ ( 0.34 ) ​ $ ( 0.77 ) ​ $ ( 0.66 ) ​ The following weighted average outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been anti-dilutive: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended June 30, ​ Six Months Ended June 30, ​ 2025 2024 2025 2024 Options to purchase common stock ​ ​ 16,825,819 ​ ​ 15,656,198 ​ ​ 16,809,703 ​ ​ 15,735,754 Unvested restricted stock units ​ ​ 633,509 ​ ​ 113,796 ​ ​ 651,722 ​ ​ 142,800 Total ​ ​ 17,459,328 ​ ​ 15,769,994 ​ ​ 17,461,425 ​ ​ 15,878,554 ​ 15 Table of Contents NOTE 7 PROPERTY AND EQUIPMENT Property and equipment consisted of the following amounts (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ As of June 30, ​ As of December 31, ​ 2025 2024 Leasehold improvements ​ $ 9,646 ​ $ 9,646 Laboratory equipment ​ ​ 3,863 ​ ​ 3,735 Computers and software ​ ​ 296 ​ ​ 296 Furniture and fixtures ​ ​ 511 ​ ​ 511 Property and equipment, at cost ​ ​ 14,316 ​ ​ 14,188 Less: accumulated depreciation ​ ​ ( 5,721 ) ​ ​ ( 4,685 ) Property and equipment, net ​ $ 8,595 ​ $ 9,503 ​ ​ Depreciation expense was $ 0.5 million and $ 1.0 million for the three and six months ended June 30, 2025 and 2024, respectively. NOTE 8 ACCRUED OTHER EXPENSES Accrued other expenses consisted of the following amounts (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ As of June 30, ​ As of December 31, ​ 2025 2024 Accrued research and development costs ​ $ 5,254 ​ $ 6,488 Accrued other ​ ​ 682 ​ ​ 741 Total accrued other expenses ​ $ 5,936 ​ $ 7,229 ​ ​ NOTE 9 SEGMENT REPORTING There have been no changes in the Company’s assessment of the basis of segmentation or in the basis of measurement of segment profit or loss since the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 3, 2025. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended June 30, ​ Six Months Ended June 30, ​ 2025 2024 2025 2024 Operating expenses: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Contracted research expense ​ $ 19,017 ​ $ 20,313 ​ $ 40,316 ​ $ 38,118 Personnel expense ​ ​ 10,894 ​ ​ 8,002 ​ ​ 21,518 ​ ​ 15,735 Stock-based compensation expense ​ ​ 7,733 ​ ​ 5,224 ​ ​ 16,792 ​ ​ 10,095 Other segment expense (a) ​ ​ 4,443 ​ ​ 4,088 ​ ​ 8,907 ​ ​ 7,959 Depreciation ​ ​ 523 ​ ​ 480 ​ ​ 1,036 ​ ​ 953 Segment net loss ​ ​ ( 42,610 ) ​ ​ ( 38,107 ) ​ ​ ( 88,569 ) ​ ​ ( 72,860 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Reconciliation of net loss ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Interest income ​ ​ 6,495 ​ ​ 6,610 ​ ​ 11,656 ​ ​ 12,838 Net Loss ​ $ ( 36,115 ) ​ $ ( 31,497 ) ​ $ ( 76,913 ) ​ $ ( 60,022 ) a Other segment expense included in Segment net loss includes contracted administrative expenses, intellectual property fees, software costs, occupancy & equipment costs, and other overhead expenses. ​ ​ ​ ​ 16 Table of Contents ​ ​ ​ ​ ​ ​ ​ ​