CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares |
Mar. 31, 2026 |
Dec. 31, 2025 |
|---|---|---|
| CONDENSED BALANCE SHEETS | ||
| Preferred stock, par value | $ 0.0001 | $ 0.0001 |
| Preferred stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
| Preferred stock, shares issued | 0 | 0 |
| Preferred stock, shares outstanding | 0 | 0 |
| Common stock, par value | $ 0.0001 | $ 0.0001 |
| Common stock, shares authorized | 1,000,000,000 | 1,000,000,000 |
| Common stock, shares issued | 107,481,522 | 106,249,579 |
| Common stock, shares outstanding | 107,481,522 | 106,249,579 |
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands |
3 Months Ended | |
|---|---|---|
Mar. 31, 2026 |
Mar. 31, 2025 |
|
| Operating expenses | ||
| Research and development | $ 42,651 | $ 36,757 |
| General and administrative | 11,464 | 9,202 |
| Total operating expenses | 54,115 | 45,959 |
| Loss from operations | (54,115) | (45,959) |
| Other income | ||
| Interest income | 5,102 | 5,161 |
| Total other income | 5,102 | 5,161 |
| Net loss | (49,013) | (40,798) |
| Other comprehensive income (loss): | ||
| Unrealized loss on available-for-sale securities, net | (929) | (19) |
| Total comprehensive loss | $ (49,942) | $ (40,817) |
| Net loss per share, basic (in dollars per share) | $ (0.46) | $ (0.43) |
| Net loss per share, diluted (in dollars per share) | $ (0.46) | $ (0.43) |
| Weighted-average shares outstanding, basic (in shares) | 107,116,709 | 95,130,053 |
| Weighted-average shares outstanding, diluted (in shares) | 107,116,709 | 95,130,053 |
DESCRIPTION OF BUSINESS |
3 Months Ended |
|---|---|
Mar. 31, 2026 | |
| DESCRIPTION OF BUSINESS | |
| DESCRIPTION OF BUSINESS | 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 is headquartered in Boulder, Colorado. The Company is a late-stage clinical 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 a selective, fast myofiber (type II) myosin small molecule inhibitor designed to address contraction-induced muscle injury currently being studied in multiple Phase 2 trials in Becker muscular dystrophy (Becker) and Duchenne muscular dystrophy (Duchenne), which are being held in the U.S., Israel, and certain countries in Europe and Australasia, and EDG-7500 is a novel, oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with hypertrophic cardiomyopathy (HCM) and other diseases of diastolic dysfunction currently being studied in a multipart Phase 2 trial for the potential treatment of obstructive and nonobstructive HCM. The Company is also developing EDG-15400, currently in a Phase 1 trial of healthy adults with the future disease target of heart failure with preserved ejection fraction (HFpEF), and 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 $595.4 million and cash, cash equivalents and marketable securities of $499.6 million as of March 31, 2026. 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 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) 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 $499.6 million of cash, cash equivalents and marketable securities on hand as of March 31, 2026 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. |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
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| SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 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, 2025 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 26, 2026. 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. 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):
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 March 31, 2026, the remaining contractual maturities of $439.1 million of marketable securities were less than and $27.5 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 March 31, 2026 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 November 2024, the FASB issued Accounting Standards Update (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, SG&A, 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. In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow Scope Improvements. This ASU is expected to improve the navigability of the required interim disclosures, clarify when that guidance is applicable, and provide additional guidance on what disclosures should be included in interim reporting periods. It also adds a principle requiring entities to disclose events since the end of the last annual reporting period that have a material impact on the entity. This ASU is effective for interim reporting periods within annual reporting periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact that the adoption of this standard will have on its interim financial statements. |
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PREFERRED STOCK AND COMMON STOCK |
3 Months Ended |
|---|---|
Mar. 31, 2026 | |
| PREFERRED STOCK AND COMMON STOCK | |
| PREFERRED STOCK AND COMMON STOCK | 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 March 31, 2026, 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. |
STOCK-BASED COMPENSATION AWARDS |
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Mar. 31, 2026 | |||||||||||||||||||||||||||||||||||||||||||
| STOCK-BASED COMPENSATION AWARDS | |||||||||||||||||||||||||||||||||||||||||||
| STOCK-BASED COMPENSATION AWARDS | 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 generally 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 March 31, 2026, there were 7,909,448 shares of common stock available for future issuance under the 2021 Plan. 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. The vesting of stock options is stated in each individual grant agreement, which is generally four years, and expires 10 years after the date of grant. The fair value of each RSU is based on the closing price of the Company’s common stock on the date of grant and vests over 4 years. As of March 31, 2026, there were 688,500 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 March 31, 2026, 1,147,365 options were both outstanding and exercisable. 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 March 31, 2026, there were 3,908,630 shares of common stock available for future issuance under 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 was allocated as follows (in thousands):
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COMMITMENTS AND CONTINGENCIES |
3 Months Ended |
|---|---|
Mar. 31, 2026 | |
| COMMITMENTS AND CONTINGENCIES. | |
| COMMITMENTS AND CONTINGENCIES | 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 months ended March 31, 2026 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 March 31, 2026. |
NET LOSS PER SHARE |
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| NET LOSS PER SHARE | 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):
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:
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PROPERTY AND EQUIPMENT |
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Mar. 31, 2026 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| PROPERTY AND EQUIPMENT | NOTE 7 PROPERTY AND EQUIPMENT Property and equipment consisted of the following amounts (in thousands):
Depreciation expense was $0.5 million for each of the three months ended March 31, 2026 and 2025. |
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ACCRUED OTHER EXPENSES |
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Mar. 31, 2026 | |||||||||||||||||||||||||||||||||||||||||||
| ACCRUED OTHER EXPENSES | |||||||||||||||||||||||||||||||||||||||||||
| ACCRUED OTHER EXPENSES | NOTE 8 ACCRUED OTHER EXPENSES Accrued other expenses consisted of the following amounts (in thousands):
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SEGMENT REPORTING |
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Mar. 31, 2026 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SEGMENT REPORTING | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SEGMENT REPORTING | NOTE 9 SEGMENT REPORTING There have been no changes in the Company’s assessment of the basis of segmentation or in the basis of measurement of segment profit or loss since the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 26, 2026.
a Other segment expense included in Segment net loss includes contracted administrative expenses, intellectual property fees, software costs, occupancy & equipment costs, and other overhead expenses. |
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Pay vs Performance Disclosure - USD ($) $ in Thousands |
3 Months Ended | |
|---|---|---|
Mar. 31, 2026 |
Mar. 31, 2025 |
|
| Pay vs Performance Disclosure | ||
| Net Income (Loss) | $ (49,013) | $ (40,798) |
Insider Trading Arrangements |
3 Months Ended |
|---|---|
|
Mar. 31, 2026
shares
| |
| Trading Arrangements, by Individual | |
| Non-Rule 10b5-1 Arrangement Adopted | false |
| Non-Rule 10b5-1 Arrangement Terminated | false |
| Alan Russell | |
| Trading Arrangements, by Individual | |
| Material Terms of Trading Arrangement | On March 13, 2026, Alan Russell, Chief Scientific Officer and Director, adopted a Rule 10b5-1 trading arrangement providing for the sale from time to time of up to 200,000 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(c). The duration of the trading arrangement is until July 1, 2027, or earlier if all transactions under the trading arrangement are completed. |
| Name | Alan Russell |
| Title | Chief Scientific Officer and Director |
| Rule 10b5-1 Arrangement Adopted | true |
| Adoption Date | March 13, 2026 |
| Aggregate Available | 200,000 |
| Expiration Date | July 1, 2027 |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) |
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Mar. 31, 2026 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Basis of Presentation | 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, 2025 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 26, 2026. 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. |
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| Marketable Securities, Available for Sale | 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. 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):
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 March 31, 2026, the remaining contractual maturities of $439.1 million of marketable securities were less than and $27.5 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 March 31, 2026 were primarily due to changes in interest rates, including market credit spreads, and not due to increased credit risks associated with specific securities. |
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| Accounting Standards Not Yet Adopted | Accounting Standards Not Yet Adopted In November 2024, the FASB issued Accounting Standards Update (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, SG&A, 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. In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow Scope Improvements. This ASU is expected to improve the navigability of the required interim disclosures, clarify when that guidance is applicable, and provide additional guidance on what disclosures should be included in interim reporting periods. It also adds a principle requiring entities to disclose events since the end of the last annual reporting period that have a material impact on the entity. This ASU is effective for interim reporting periods within annual reporting periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact that the adoption of this standard will have on its interim financial statements. |
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) |
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| SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of financial assets measured at fair value on a recurring basis by level within the fair value hierarchy | 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):
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STOCK-BASED COMPENSATION AWARDS (Tables) |
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Mar. 31, 2026 | |||||||||||||||||||||||||||||||||||||||||||
| STOCK-BASED COMPENSATION AWARDS | |||||||||||||||||||||||||||||||||||||||||||
| Schedule of stock-based compensation expense | Total stock-based compensation expense related to all equity plans was allocated as follows (in thousands):
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NET LOSS PER SHARE (Tables) |
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Mar. 31, 2026 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| NET LOSS PER SHARE | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of computation of the basic and diluted net loss per share | The following table sets forth the computation of the basic and diluted net loss per share (in thousands, except share and per share data):
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| Schedule of potentially dilutive securities |
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PROPERTY AND EQUIPMENT (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2026 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PROPERTY AND EQUIPMENT | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of property plant and equipment | Property and equipment consisted of the following amounts (in thousands):
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ACCRUED OTHER EXPENSES (Tables) |
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Mar. 31, 2026 | |||||||||||||||||||||||||||||||||||||||||||
| ACCRUED OTHER EXPENSES | |||||||||||||||||||||||||||||||||||||||||||
| Schedule of accrued other expenses | Accrued other expenses consisted of the following amounts (in thousands):
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SEGMENT REPORTING (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2026 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| SEGMENT REPORTING | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of revenue and expenses for the operating segment to consolidated amounts |
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. |
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DESCRIPTION OF BUSINESS (Details) - USD ($) $ / shares in Units, $ in Thousands |
1 Months Ended | ||||
|---|---|---|---|---|---|
Apr. 03, 2025 |
May 10, 2024 |
Apr. 30, 2025 |
Mar. 31, 2026 |
Dec. 31, 2025 |
|
| Subsidiary, Sale of Stock [Line Items] | |||||
| Accumulated deficit | $ 595,384 | $ 546,371 | |||
| Cash, cash equivalents and marketable securities | $ 499,600 | ||||
| Shares issued | 9,935,419 | ||||
| Share price | $ 20.13 | ||||
| Gross proceeds | $ 200,000 | ||||
| Proceeds from issuance of common stock | 187,100 | ||||
| Underwriting discounts and commissions | 12,000 | ||||
| Offering expenses | $ 900 | ||||
| At-the-market program | Common Stock | Maximum | |||||
| Subsidiary, Sale of Stock [Line Items] | |||||
| Maximum potential aggregate sales proceeds, sales agreement | $ 175,000 |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Financial Assets Transfers and Maturities (Details) $ in Thousands |
3 Months Ended |
|---|---|
|
Mar. 31, 2026
USD ($)
| |
| Remaining contractual maturities | |
| Fair value assets transfer from level 1 to 2 | $ 0 |
| Less than one year | 439,100 |
| One year through two years | $ 27,500 |
| Minimum | |
| Remaining contractual maturities | |
| Maturity period | 1 year |
| Maximum | |
| Remaining contractual maturities | |
| Maturity period | 2 years |
PREFERRED STOCK AND COMMON STOCK - Narrative (Details) |
Mar. 31, 2026
Vote
$ / shares
shares
|
Dec. 31, 2025
$ / shares
shares
|
|---|---|---|
| PREFERRED STOCK AND COMMON STOCK | ||
| Total shares authorized | 1,200,000,000 | |
| Common stock authorized (in shares) | 1,000,000,000 | 1,000,000,000 |
| Preferred stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
| Par value of common stock (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 |
| Par value of preferred stock (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 |
| Voting rights upon conversion into common stock | Vote | 1 |
STOCK-BASED COMPENSATION AWARDS - Inducement Equity Incentive Plan (Details) - 2024 Inducement Equity Incentive Plan - shares |
Aug. 10, 2024 |
Mar. 31, 2026 |
|---|---|---|
| Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
| Shares reserved for the issuance of stock options | 2,000,000 | |
| Shares available for issuance | 688,500 | |
| Employee Stock Option | ||
| Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
| Vesting period (in years) | 4 years | |
| Expiration period (in years) | 10 years | |
| Restricted stock units | ||
| Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
| Vesting period (in years) | 4 years |
STOCK-BASED COMPENSATION AWARDS - Founder Stock Options (Details) - Founder stock options - $ / shares |
Sep. 19, 2017 |
Mar. 31, 2026 |
|---|---|---|
| Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
| Options granted (in shares) | 1,795,880 | |
| Exercise price (in dollars per share) | $ 0.18 | |
| Vesting period (in years) | 4 years | |
| Expiration period (in years) | 15 years | |
| Options exercisable (in shares) | 1,147,365 | |
| Options outstanding (in shares) | 1,147,365 |
STOCK-BASED COMPENSATION AWARDS - Employee Stock Purchase Plan (Details) - 2021 Employee Stock Purchase Plan |
3 Months Ended |
|---|---|
|
Mar. 31, 2026
period
shares
| |
| Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] | |
| Shares initially reserved for issuance | 504,000 |
| Percentage of outstanding shares | 1.00% |
| Shares reserved for issuance of common stock | 3,908,630 |
| Number of offering periods | period | 2 |
| Maximum percentage of contributions under ESPP | 15.00% |
| Maximum number of shares per employee (in shares) | 6,000 |
| Discounted purchase price in relation to market price (percent) | 85.00% |
| Maximum | |
| Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] | |
| Shares available for issuance | 1,008,000 |
STOCK-BASED COMPENSATION AWARDS - Stock based compensation expense (Details) - USD ($) $ in Thousands |
3 Months Ended | |
|---|---|---|
Mar. 31, 2026 |
Mar. 31, 2025 |
|
| Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
| Total stock-based compensation expense | $ 8,715 | $ 9,059 |
| Research and development | ||
| Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
| Total stock-based compensation expense | 5,097 | 5,867 |
| General and administrative | ||
| Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
| Total stock-based compensation expense | $ 3,618 | $ 3,192 |
NET LOSS PER SHARE - Computation of Net loss per share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | |
|---|---|---|
Mar. 31, 2026 |
Mar. 31, 2025 |
|
| Numerator | ||
| Net loss | $ (49,013) | $ (40,798) |
| Denominator | ||
| Weighted-average shares outstanding used in computing net loss per share, basic | 107,116,709 | 95,130,053 |
| Weighted-average shares outstanding used in computing net loss per share, diluted | 107,116,709 | 95,130,053 |
| Net loss per share, basic | $ (0.46) | $ (0.43) |
| Net loss per share, diluted | $ (0.46) | $ (0.43) |
NET LOSS PER SHARE - Potentially dilutive securities (Details) - shares |
3 Months Ended | |
|---|---|---|
Mar. 31, 2026 |
Mar. 31, 2025 |
|
| Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
| Potentially dilutive securities (in shares) | 19,905,104 | 17,447,049 |
| Employee Stock Option [Member] | ||
| Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
| Potentially dilutive securities (in shares) | 18,676,439 | 16,776,912 |
| Unvested restricted stock units | ||
| Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
| Potentially dilutive securities (in shares) | 1,228,665 | 670,137 |
PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands |
3 Months Ended | ||
|---|---|---|---|
Mar. 31, 2026 |
Mar. 31, 2025 |
Dec. 31, 2025 |
|
| Property, Plant and Equipment [Line Items] | |||
| Property and equipment, at cost | $ 14,702 | $ 14,600 | |
| Less: accumulated depreciation | (7,306) | (6,769) | |
| Property and equipment, net | 7,396 | 7,831 | |
| Depreciation expense | 537 | $ 513 | |
| Leasehold improvements | |||
| Property, Plant and Equipment [Line Items] | |||
| Property and equipment, at cost | 9,825 | 9,646 | |
| Laboratory equipment | |||
| Property, Plant and Equipment [Line Items] | |||
| Property and equipment, at cost | 4,070 | 4,070 | |
| Computers and software | |||
| Property, Plant and Equipment [Line Items] | |||
| Property and equipment, at cost | 296 | 296 | |
| Furniture and fixtures | |||
| Property, Plant and Equipment [Line Items] | |||
| Property and equipment, at cost | $ 511 | 511 | |
| Construction in process | |||
| Property, Plant and Equipment [Line Items] | |||
| Property and equipment, at cost | $ 77 | ||
ACCRUED OTHER EXPENSES (Details) - USD ($) $ in Thousands |
Mar. 31, 2026 |
Dec. 31, 2025 |
|---|---|---|
| ACCRUED OTHER EXPENSES | ||
| Accrued research and development costs | $ 7,367 | $ 7,161 |
| Accrued other | 1,188 | 759 |
| Total accrued other expenses | $ 8,555 | $ 7,920 |
SEGMENT REPORTING (Details) - USD ($) $ in Thousands |
3 Months Ended | |
|---|---|---|
Mar. 31, 2026 |
Mar. 31, 2025 |
|
| Segment Reporting Information [Line Items] | ||
| Number of reportable segments not disclosed | true | |
| Operating expenses: | ||
| Stock-based compensation expense | $ 8,715 | $ 9,059 |
| Loss from operations | (54,115) | (45,959) |
| Interest income | 5,102 | 5,161 |
| Net loss | (49,013) | (40,798) |
| Single reportable segment | ||
| Operating expenses: | ||
| Contracted research expense | 23,942 | 21,298 |
| Personnel expense | 14,725 | 10,624 |
| Stock-based compensation expense | $ 8,715 | 9,059 |
| Segment Reporting, Other Segment Item, Composition, Description | Other segment expense included in Segment net loss includes contracted administrative expenses, intellectual property fees, software costs, occupancy & equipment costs, and other overhead expenses | |
| Other segment expense | $ 6,196 | 4,464 |
| Depreciation | 537 | 514 |
| Loss from operations | (54,115) | (45,959) |
| Interest income | 5,102 | 5,161 |
| Net loss | $ (49,013) | $ (40,798) |