Edgewise Therapeutics reported $1.17 billion net income for Q3 2026

Cover page 2 changes

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For the quarterly period ended June September 30, 2026

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As of July October 31, 2026, there were 108,604,129 109,482,763 shares of the registrant's common stock outstanding.

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Financial Statements (Unaudited) 1 change

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Condensed Statements of Operations and Comprehensive Income (Loss)

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Forward-looking statements 7 changes

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● the timing, scope and likelihood of domestic and foreign regulatory filings and approvals, including the timing of Investigational New Drug (IND) applications for, and final U.S. Food & Drug Administration (FDA) approval of or Investigational New Drugs of, EDG-7500, EDG-15400, product candidates from our EDG-003 cardiometabolic discovery program and any other future product candidates;

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● our ability to become a commercial-ready biopharmaceutical company;

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● our plans to focus the majority of our resources on the development of EDG-7500 and to prioritize and allocate resources among our programs;

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● our plans to develop our supply chain and to establish commercial manufacturing and supply arrangements;

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● the timing and amount of any future recognition of contingent consideration from the Sevasemten Sale and the related estimates and judgments;

● the release to us of amounts held in escrow under the Sevasemten Purchase Agreement, and our indemnification obligations thereunder;

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● the expected effects of the Sevasemten Sale on our operating expenses and other income;

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Financial statements 39 changes

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Current assets held for sale

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Current liabilities held for sale

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Other long term liabilities

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Preferred stock, $ .0001 par value per share; 200,000,000 shares authorized and no shares issued or outstanding as of June September 30, 2026 and December 31, 2025

Common stock, $ .0001 par value per share; 1,000,000,000 shares authorized as of June September 30, 2026 and December 31, 2025; 107,776,380 109,457,922 shares and 106,249,579 shares issued and outstanding as of June September 30, 2026 and December 31, 2025, respectively

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Accumulated other comprehensive income (loss) income

Retained earnings (accumulated deficit)

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Condensed Statements of Operations and Comprehensive Income (Loss)

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Six months ended June 30,

Three months ended June September 30,

Nine months ended September 30,

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Gain on the Sevasemten Sale

Income (loss) before income tax expense

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Total comprehensive loss

Net loss per share, basic and diluted

Weighted-average shares outstanding, basic and diluted

Unrealized (loss) gain on available-for-sale securities, net ( 5,102 )

Total comprehensive income (loss)

Basic earnings (loss) per share

Diluted earnings (loss) per share

Weighted-average shares outstanding used in basic earnings (loss) per share

Weighted-average shares outstanding used in diluted earnings (loss) per share

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Exercise of stock options and vesting of restricted stock units

Stock-based compensation

Other comprehensive income

Balance as of September 30, 2025

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Exercise of stock options and vesting of restricted stock units

Stock-based compensation

Other comprehensive income (loss)

Balance as of September 30, 2026

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Six months ended June 30,

Nine months ended September 30,

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Adjustments to reconcile net income (loss) to net cash used in operating activities:

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Gain on the Sevasemten Sale

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Proceeds from the Sevasemten Sale, net of transaction costs

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Supplemental disclosures of non-cash investing and financing activities:

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Supplemental disclosures of cash flow information:

Cash paid for income taxes, net (1)

(1) For the nine months ended September 30, 2026, the amount includes $ 23.2 million paid to purchase transferable federal income tax credits that were utilized during the period.

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Note 1: DESCRIPTION OF BUSINESS 9 changes

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Edgewise Therapeutics, Inc. (the Company) is a late-stage clinical clinical-stage biopharmaceutical company focused on advancing therapies for people living with for serious cardiovascular diseases. The Company's pipeline includes EDG-7500, a novel, oral, selective, cardiac sarcomere modulator, in development for the treatment of hypertrophic cardiomyopathy (HCM), including both obstructive HCM (oHCM) and nonobstructive HCM (nHCM). The Company is also advancing EDG-15400, an oral next-generation cardiac sarcomere modulator in clinical development for the treatment of heart failure with preserved ejection fraction (HFpEF). In addition, the Company is leveraging its precision medicine platform to advance additional research programs focused on genetically defined cardiovascular and cardiometabolic diseases.

On May 31, 2026, the Company entered into an Asset Purchase Agreement (Sevasemten Purchase Agreement) with Servier Pharmaceuticals LLC and Les Laboratoires Servier (Servier) for the sale of the sevasemten muscular dystrophy program, including certain related assets, intellectual property, know-how, select employees, contracts, regulatory filings and clinical data, and assumed certain related liabilities (Sevasemten Sale). As a result, the related disposal group was classified as held for sale as of June 30, 2026, and The Sevasemten Sale closed on July 10, 2026. Following completion of the Sevasemten Sale, the Company is focused on advancing its cardiovascular pipeline and related research and development activities.

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The Company has an accumulated deficit of $ 652.7 million and cash, cash equivalents and marketable securities of $ 460.7 million as of June 30, 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.

The Company has retained earnings of $ 513.4 million and cash, cash equivalents and marketable securities of $ 1,743.9 million as of September 30, 2026. The Company may seek additional capital in the future to support strategic opportunities, business development activities, commercialization initiatives or expanded development programs.

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As a subsequent event, on July 10, 2026, the Company completed the Sevasemten Sale receiving $ 1,550 million in upfront cash proceeds and is eligible to receive up to $ 1,100 million in potential future milestone payments, including (a) a potential milestone payment upon achieving U.S. marketing approval for sevasemten for

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.

On July 10, 2026, the Company completed the Sevasemten Sale receiving $ 1,396.1 million in upfront cash proceeds, with an additional $ 153.9 million deposited into escrow in accordance with the Sevasemten Purchase Agreement, for total expected initial proceeds of $ 1,550.0 million. The Company is also eligible to receive up to $ 1,100.0 million in potential future milestone payments, including (a) a potential milestone payment upon achieving U.S. marketing approval for sevasemten for Becker muscular dystrophy in the amount of (i) $ 200 200.0 million, in cash, payable in the event of an approved labelling including specified adult and adolescent populations or (ii) $ 100 100.0 million in cash, payable in the event of an approved labelling including only specified adult populations (if (i) has not previously been achieved); (b) a potential milestone payment of $ 600 600.0 million in cash, payable upon the achievement of U.S. marketing approval for sevasemten for Duchenne muscular dystrophy; and (c) a potential milestone payment of $ 300 300.0 million in cash, payable upon the achievement of annual U.S. net sales of sevasemten products exceeding $ 550 550.0 million. Together, the upfront cash total expected initial proceeds and potential future milestone payments constitute aggregate potential consideration of up to $ 2,650 2,650.0 million.

The Company may seek additional capital in the future through equity or debt financings, strategic transactions or other sources. The availability and terms of any future financing will depend on a number of factors, including the Company's clinical and regulatory progress, market conditions and other factors. If the Company raises additional capital through the issuance of equity securities, its stockholders may experience dilution, and debt financing, if available, may include restrictive covenants. The Company's future capital requirements will depend on its operating plans, including the scope and timing of its clinical development programs, commercialization activities and potential strategic opportunities.

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 its $ 460.7 1,743.9 million of cash, cash equivalents and marketable securities on hand as of June September 30, 2026 and the $ 1,550 million in proceeds from the Sevasemten Sale received on July 10, 2026 will be sufficient to fund its planned 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 12 changes

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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. Except as noted in this Note 2, there have been no material changes to the summary of significant accounting policies as disclosed in that filing.

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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, allowance for credit losses, 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.

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As of September 30, 2026

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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 September 30, 2026, the $ 1,159.3 million of marketable securities had remaining contractual maturities of less than one year and $ 388.9 521.5 million of marketable securities were less than had remaining contractual maturities between one year and two 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 September 30, 2026 were primarily due to changes in interest rates, including market credit spreads, and not due to increased credit risks associated with specific securities.

Contingent Consideration

In connection with the Sevasemten Sale, the Company may receive additional consideration upon the achievement of specified regulatory and commercial milestones. The Company accounted for the Sevasemten Sale as a derecognition of nonfinancial assets under ASC 610-20. In determining the consideration recognized in the gain on sale, the Company applies the recognition and measurement guidance in ASC 606, including the requirements for estimating and constraining variable consideration.

The contingent milestone payments represent variable consideration. The Company estimates variable consideration using the most likely amount method, which it believes is appropriate because the milestone arrangements have a limited number of discrete outcomes. The Company includes estimated variable consideration in the gain on sale only to the extent that it is probable that a significant reversal in the cumulative gain recognized will not occur when the related uncertainty is resolved.

Recently Adopted Accounting Standards

In September 2025, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2025-07, Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606): Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract . This ASU adds a new scope exception, with exceptions, to derivative accounting guidance for non-exchange traded contracts with underlyings based on operations or activities specific to one of the parties to the contract. This ASU is effective for the Company's interim and annual reporting periods beginning on January 1, 2027. The guidance may be applied on a prospective or modified retrospective basis and early adoption is permitted. During the third quarter of 2026, the Company early adopted this ASU on a prospective basis to new contracts entered into on or after January 1, 2026. The adoption of this ASU did not have a material impact on the Company's financial statements as of September 30, 2026.

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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 Improvement s. 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.

Note 3: PREFERRED STOCK AND COMMON STOCK 1 change

The Company is authorized to issue two classes of stock designated as common stock and preferred stock. As of June September 30, 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.

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Note 4: STOCK-BASED COMPENSATION AWARDS 8 changes

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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 June September 30, 2026, there were 7,832,215 6,644,216 shares of common stock available for future issuance under the 2021 Plan.

During the nine months ended September 30, 2026, under the 2021 Plan, the Company granted 1,382,848 stock options with a fair value of $ 42.0 million that vest over a weighted average period of 3.8 years and 654,948 RSUs with a fair value of $ 28.4 million that vest over a weighted average period of 4.0 years.

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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 June September 30, 2026, there were 352,000 703,748 shares available for future issuance under the Inducement Plan.

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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 September 30, 2026, 1,147,365 1,077,717 options were both outstanding and exercisable.

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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 September 30, 2026, there were 3,848,431 shares of common stock available for future issuance under the 2021 ESPP.

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Six months ended June 30,

Three months ended June September 30,

Nine months ended September 30,

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Note 5: COMMITMENTS AND CONTINGENCIES 4 changes

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 nine months ended June September 30, 2026 and no material legal proceedings are currently pending or threatened.

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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 September 30, 2026.

In connection with the Sevasemten Sale, the Company agreed to provide the buyers with indemnification for specified matters under the related transaction agreements. As of September 30, 2026, the Company has not recognized contingent consideration subject to the indemnity arrangements in the gain on sale. The Company is continuing to evaluate potential resolution alternatives and will reassess the amount of consideration expected to be recoverable, the need for any liability recognition, and related disclosure requirements at each reporting date.

The Company has committed to purchase federal transferable production tax credits. As of September 30, 2026, the Company has a remaining commitment of $ 40.0 million through January 2027. The Company's commitments are contingent upon the satisfaction of certain legal and contractual conditions from the sellers, and the continued availability of the credits under federal tax laws. The Company expects to utilize these credits in the same quarter in which they are purchased, offsetting federal income tax estimated payments and reducing income tax expense in the associated periods.

Note 7: PROPERTY AND EQUIPMENT 1 change

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Depreciation expense was $ 0.5 million and $ 1.1 1.6 million for the three and six nine months ended June September 30, 2026 and $ 0.5 million and $ 1.0 1.6 million for the three and six nine months ended June September 30, 2025.

Note 8: ACCRUED OTHER EXPENSES 1 change

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Deferred income – transition services agreement (TSA) performance obligation, current portion

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Note 9: SEGMENT REPORTING 7 changes

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Six Months Ended June 30,

Three months ended June September 30,

Nine months ended September 30,

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Segment net income (loss)

Reconciliation of net income (loss)

Gain on the Sevasemten Sale

a Other segment expense included in Segment net income (loss) includes contracted administrative expenses, intellectual property fees, software costs, occupancy & equipment costs, and other overhead expenses .

MD&A 94 changes

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Since our inception in 2017, we have applied our deep expertise in muscle biology and small molecule drug discovery to build a proprietary precision medicine platform. This foundation has generated multiple clinical and preclinical programs across skeletal and cardiac muscle, including sevasemten for muscular dystrophies and our cardiovascular portfolio of novel, oral cardiac sarcomere modulators. In May 2026, we entered into an Asset Purchase Agreement under which Servier Pharmaceuticals LLC and Les Laboratoires Servier (Servier) acquired sevasemten and our muscular dystrophy program for $1,550 (Sevasemten Sale). The transaction was completed on July 10, 2026, and we received $1,396.1 million in upfront cash consideration and proceeds, with an additional $153.9 million deposited into escrow in accordance with the Sevasemten Purchase Agreement, for total expected initial proceeds of $1,550.0 million. We are also eligible to receive up to $1,100 $1,100.0 million in additional regulatory and commercial milestone payments, for aggregate potential consideration of up to $2,650 $2,650.0 million. (Sevasemten Sale). The resulting gain on July 10, 2026, the Sevasemten Sale was completed. approximately $1,348.1 million.

Following this transaction, Edgewise is positioned as a cardiovascular-focused late-stage clinical clinical-stage biopharmaceutical company advancing therapies for people living with serious cardiovascular diseases. Our lead cardiovascular program, EDG-7500, is a novel, oral, selective cardiac sarcomere modulator currently being studied in a for which we announced positive topline data from the 12-week Part D portion of our multipart Phase 2 trial in patients with obstructive and nonobstructive hypertrophic cardiomyopathy (HCM), with a Phase 3 program targeted trial which we plan to initiate in the fourth quarter of 2026. EDG-15400, our second cardiovascular product candidate, is currently in a Phase 1 2 trial in healthy adults with a future disease target of symptomatic heart failure with preserved ejection fraction and we expect to initiate (HFpEF) who have a Phase 2 trial in the second half left ventricular ejection fraction (LVEF) of 2026. at least 50%. We are also continuing to advance preclinical discovery efforts, including additional cardiovascular and cardiometabolic targets, as we pursue our mission of changing the lives of patients and families affected by serious cardiovascular diseases.

We have incurred significant losses since the commencement of our operations, Our net losses were $57.3 million and $106.3 million except for the three and six nine months ended June September 30, 2026 respectively, and $36.1 where we recognized net income of $1,166.2 million and $76.9 $1,059.8 million, respectively, primarily due to the gain recognized on the Sevasemten Sale. Our net losses for the three and six nine months ended June September 30, 2025 respectively, were $40.7 million and $117.6 million, respectively. Excluding the gain recognized on the Sevasemten Sale, we expect to continue to incur significant losses for the foreseeable future as we advance our product candidates through preclinical development and clinical trials and seek regulatory approval of our product candidates. Our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities.

As of June September 30, 2026, we had an accumulated deficit retained earnings of $652.7 $513.4 million. To date, we have financed our operations primarily through private placements of convertible preferred stock and public offerings of our common stock. From inception to our initial public offering, private placements provided gross proceeds of $160.7 million, and, as of June September 30, 2026, we generated net proceeds from our initial public offering, follow-on public offering, issuance of our common stock under an "at the market offering" program (the ATM Program), and the January 2024 and April 2025 underwritten registered direct offerings of $793.7 million. We believe that our existing cash and cash equivalents and marketable securities of $460.7 million, together with the $1,550 $1,743.9 million in upfront cash proceeds from the Sevasemten Sale received on July 10, 2026, will enable us to fund our planned operating expenses and capital expenditure requirements through at least the next 12 months.

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● the cost of external manufacturing drug products for use in our preclinical studies and ongoing and planned clinical trials including under agreements with third parties such as consultants and contract development and manufacturing organizations (CDMOs);

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● facilities, depreciation and other expenses, which include direct or allocated expenses for rent and maintenance of facilities; and

● expenses related to our obligations under the transition services agreement (TSA); and

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Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to the increased size and duration of later-stage clinical trials. In June 2026, we announced positive topline data for our multipart Phase 2 trial with EDG-7500 for people with HCM (CIRRUS-HCM) and are planning to initiate a Phase 3 trial for EDG-7500 in the fourth quarter of 2026. and We have completed dosing in the our Phase 1 trial with EDG-15400 of in healthy adults with the future disease target of HFpEF and are planning to initiate a we have begun dosing patients in our Phase 2 trial for with EDG-15400 in the second half adults with symptomatic HFpEF who have an LVEF of 2026. at least 50% (EQUINOX-HFpEF). As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance EDG-7500, EDG-15400, and candidates from our EDG-003 cardiometabolic discovery program through clinical trials and additional product candidates; continue to develop our proprietary drug discovery platform; continue to discover and develop additional product candidates; and hire additional personnel.

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Other income includes reimbursements for specified costs incurred in providing transition services to Servier and recognition of consideration allocated to those services at the closing of the Sevasemten Sale. We deferred $7.8 million of the closing consideration and recognize that amount as the related services are provided. Costs incurred in providing transition services are recorded within the applicable operating expense categories. Refer to Note 10 of our financial statements appearing in this Quarterly Report for further information regarding the Sevasemten Sale.

Gain on the Sevasemten Sale

Gain on the Sevasemten Sale reflects the gain recognized upon the July 10, 2026 sale of the sevasemten program to Servier. The gain represents consideration recognized at closing, less the net carrying value of the assets and liabilities transferred, transaction costs, and other closing-related adjustments. No contingent milestone consideration was recognized as of September 30, 2026.

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Comparison of the three months ended June September 30, 2026 and 2025

The following table summarizes our results of operations for the three months ended June September 30, 2026 and 2025:

Three months ended June September 30,

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Gain on the Sevasemten Sale

Income (loss) before income tax expense

Income tax expense (benefit)

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Three months ended June September 30,

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● an increase in EDG-7500 clinical program expenses of $5.0 million primarily related to an increase of $0.4 million from completion of patient activity for Part D of our multipart Phase 2 CIRRUS-HCM trial, for which Part B and Part C were fully enrolled and Part D was enrolling in the comparable period in 2025, an increase of $2.0 million from pharmacokinetic studies, and a $2.6 million increase in other development costs primarily driven by nonclinical costs and manufacturing costs to support future trials;

● an increase in EDG-15400 clinical program expenses of $3.4 million which are now shown separately in the above table due to advancing into a Phase 1 trial in the third quarter of 2025. These expenses include clinical trial and nonclinical costs, as well as manufacturing costs to support current and future trials; and

● an increase in internal costs of $5.7 million, primarily related to personnel-related costs, including stock-based compensation, resulting from increased employee headcount to support the growth of our research and development programs; and

● an increase of $0.2 million in sevasemten clinical program expenses, which was primarily related to a $1.2 million increase in clinical program expenses in the MESA trial related to increased clinical activity due to patient rollover from the GRAND CANYON trial and $0.8 million increase in the GRAND CANYON trial, partially offset by $1.8 million in decreased activity across all other sevasemten trials;

Research and development expenses were $47.5 $31.6 million and $33.6 $37.5 million for the three months ended June September 30, 2026 and 2025, respectively. The increase decrease was primarily due to higher EDG-7500, EDG-15400 and internal personnel-related lower sevasemten costs as a result of the Sevasemten Sale in July 2026, partially offset by lower higher EDG-7500, discovery and preclinical, expenses, and internal personnel-related costs, and was attributed to the following:

● a decrease of $11.1 million in sevasemten clinical program expenses as a result of the Sevasemten Sale that was completed on July 10, 2026; and

● a decrease in EDG-15400 clinical program expenses of $0.2 million, primarily driven by the completion of the Phase 1 trial in healthy adults in the second quarter of 2026, which was enrolling in the comparable period in 2025, partially offset by costs related to the initiation of the Phase 2 EQUINOX-HFpEF trial in the third quarter of 2026;

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● a decrease in discovery and preclinical expenses of $0.3 million, which was primarily driven by a decrease in EDG-15400 related costs, now shown separately, which were a significant portion of discovery, preclinical, and nonclinical expenses in the comparable period in 2025.

● an increase in EDG-7500 clinical program expenses of $2.3 million primarily related to an increase of $3.5 million in other development costs primarily driven by nonclinical costs and manufacturing costs to support future trials, partially offset by a decrease of $0.4 million from completion of our multipart Phase 2 CIRRUS-HCM trial and a decrease of $0.8 million from completion of pharmacokinetic studies;

● an increase in discovery and preclinical expenses of $1.1 million, which was primarily driven by an increase in research related manufacturing, chemistry, and pharmacokinetic research;

● an increase in internal costs of $1.5 million, primarily related to personnel-related costs, including stock-based compensation, resulting from increased employee headcount to support the growth of our research and development programs; and

● an increase of $0.5 million related to costs incurred by the Company related to obligations outlined within the TSA as part of the Sevasemten Sale.

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Six months ended June 30,

General and administrative expenses increased to $14.4 $14.6 million for the three months ended June September 30, 2026 compared to $9.1 $9.4 million for the three months ended June September 30, 2025. The increase of $5.3 $5.2 million was primarily attributable to $1.7 $1.5 million in increased personnel-related costs, including stock-based compensation, associated with organizational growth $1.4 million in increased costs associated with commercial readiness activities for sevasemten, as well as $2.3 and $3.7 million in increased professional and consulting costs, transaction costs related to the Sevasemten Sale, and other administrative costs supporting public company operations and clinical development activities.

Interest income was $4.6 $16.5 million for the three months ended June September 30, 2026 compared to $6.5 $6.2 million for the three months ended June September 30, 2025. Interest income reflects returns generated from the investment of our cash, cash equivalents and marketable securities in accordance with our investment policies and may fluctuate in future periods based on prevailing market conditions and the timing of cash deployment.

Other income for the three months ended September 30, 2026 was $3.1 million, primarily reflecting amounts recognized in connection with transition services provided to Servier following the close of the Sevasemten Sale.

Gain on the Sevasemten Sale

Gain on the Sevasemten Sale was $1,348.1 million for the three months ended September 30, 2026, following the completion of the sale to Servier on July 10, 2026. Refer to Note 10 of our financial statements appearing in this Quarterly Report for further information regarding the Sevasemten Sale.

Income tax expense for the three months ended September 30, 2026 was $155.3 million, primarily due to the gain on sale of the sevasemten program. The related tax expense was partially offset by the utilization of net operating loss carryforwards and the benefit of transferable tax credits purchased at a discount. The effective tax rate for the three months ended September 30, 2026 was 11.8%.

Comparison of the six nine months ended June September 30, 2026 and 2025

The following table summarizes our results of operations for the six nine months ended June September 30, 2026 and 2025:

Nine months ended September 30,

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Loss from operations

Gain on the Sevasemten Sale

Income (loss) before income tax expense

Income tax expense (benefit)

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Six months ended June 30,

Nine months ended September 30,

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● an increase in EDG-15400 clinical program expenses of $6.5 million which are now shown separately in the above table due to advancing into a Phase 1 trial in the third quarter of 2025. These expenses include clinical trial and nonclinical costs, as well as manufacturing costs to support current and future trials; and

Research and development expenses were $90.2 $121.8 million and $70.3 $107.8 million for the six nine months ended June September 30, 2026 and 2025, respectively. The increase was primarily due to higher EDG-7500, EDG-15400, discovery and preclinical expenses, and internal personnel-related costs, partially offset by lower discovery and preclinical sevasemten expenses, and was attributed to the following:

● an increase in EDG-7500 clinical program expenses of $6.6 $8.9 million primarily related to an increase of $1.6 $1.1 million from completion of patient activity for Part D of our multipart Phase 2 CIRRUS-HCM trial, for which Part B and Part C were completed enrollment and Part D was enrolling in the comparable period in 2025, a $2.3 $5.9 million increase in other development costs primarily driven by nonclinical costs and manufacturing costs to support future trials, and an increase of $2.7 $1.9 million from pharmacokinetic studies;

● an increase in EDG-15400 clinical program expenses of $6.3 million primarily related to an increase of $2.7 million related to the completion of the Phase 1 trial in the second quarter of 2026 for which start up and enrollment was underway in the comparable period in 2025, an increase of $1.4 million related to the initiation of our Phase 2 EQUINOX-HFpEF trial, and a $2.1 million increase in other development costs primarily driven by nonclinical costs and manufacturing costs to support future trials;

● an increase in discovery and preclinical expenses of $0.1 million, which was primarily driven by an increase in research related manufacturing, chemistry, and pharmacokinetic research, partially offset by decreased nonclinical expenses;

● an increase in internal costs of $8.6 $10.1 million, primarily related to personnel-related costs, including stock-based compensation, resulting from increased employee headcount to support the growth of our research and development programs; and

● an increase of $0.5 million related to costs incurred by the Company related to obligations outlined within the TSA as part of the Sevasemten Sale;

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● a decrease of $0.7 million in sevasemten clinical program expenses, which was primarily related to a $1.9 million decrease in spend related to a pharmacokinetic study which was completed in 2025, a $0.6 million decrease in clinical program expenses in CANYON and GRAND CANYON compared to the same period in 2025 due to patient rollover to the MESA trial. This was offset by a $1.6 million increase in clinical program expenses in the MESA trial related to increased clinical activity due to continued patient rollover from the GRAND CANYON trial; and

● a decrease in discovery and preclinical expenses of $1.0 million, which was primarily driven by a decrease in EDG-15400 related costs, now shown separately, which were a significant portion of discovery, preclinical, and nonclinical expenses in the comparable period in 2025.

● a decrease of $11.9 million in sevasemten clinical program expenses as a result of the Sevasemten Sale that was completed on July 10, 2026.

Following completion of the Sevasemten Sale on July 10, 2026, we do not expect direct external clinical program costs associated with sevasemten to will not continue, except for retained obligations and transition-services activities performed under the Transition Services Agreement. TSA.

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General and administrative expenses increased to $25.9 $40.4 million for the six nine months ended June September 30, 2026 compared to $18.3 $27.6 million for the six nine months ended June September 30, 2025. The increase of $7.6 $12.8 million was primarily attributable to $3.0 $4.6 million in increased personnel-related costs, including stock-based compensation, associated with organizational growth $2.1 million in increased costs associated with commercial readiness activities for sevasemten, as well as $2.5 and $8.2 million in increased professional and consulting costs, transaction costs related to the Sevasemten Sale, and other administrative costs supporting public company operations and clinical development activities.

Interest income was $9.7 $26.2 million for the six nine months ended June September 30, 2026 compared to $11.7 $17.8 million for the six nine months ended June September 30, 2025. Interest income reflects returns generated from the investment of our cash, cash equivalents and marketable securities in accordance with our investment policies and may fluctuate in future periods based on prevailing market conditions and the timing of cash deployment.

Other income for the nine months ended September 30, 2026 was $3.1 million, primarily reflecting amounts recognized in connection with transition services provided to Servier following the close of the Sevasemten Sale on July 10, 2026.

Gain on the Sevasemten Sale

Gain on the Sevasemten Sale was $1,348.1 million for the nine months ended September 30, 2026, following the completion of the sale to Servier on July 10, 2026. Refer to Note 10 of our financial statements appearing in this Quarterly Report for further information regarding the Sevasemten Sale.

Income tax expense for the nine months ended September 30, 2026 was $155.3 million, primarily due to the gain on the Sevasemten Sale. The related tax expense was partially offset by the utilization of net operating loss carryforwards and the benefit of transferable tax credits purchased at a discount. The effective tax rate for the nine months ended September 30, 2026 was 12.8%.

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Since our inception, we have not generated any product revenue and have incurred significant operating losses and negative cash flows from our operations. To date, we have financed our operations primarily through private placements of convertible preferred stock and public offerings of our common stock. From inception to our initial public offering, private placements provided gross proceeds of $160.7 million, and, as of June September 30, 2026, we generated net proceeds from our initial public offering, follow-on public offering, issuance of our common stock under the ATM Program, and the January 2024 and April 2025 underwritten registered direct offerings of $793.7 million. Additionally, pursuant to the Sevasemten Purchase Agreement, we completed the sale of sevasemten and our muscular dystrophy program to Servier on July 10, 2026 and we received $1,396.1 million in upfront cash consideration proceeds, with an additional $153.9 million deposited into escrow in accordance with the Sevasemten Purchase Agreement, for total expected initial proceeds of $1,550 $1,550.0 million. As of June September 30, 2026, we had cash, cash equivalents and marketable securities in the amount of $460.7 $1,743.9 million.

1 unchanged paragraph

Six months ended June 30,

Nine months ended September 30,

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Cash used in operating activities during the six months ended June 30, 2026 was $85.0 million primarily driven by our net loss for the period of $106.3 million, and was also impacted by changes in operating assets and liabilities, which decreased net working capital by $3.9 million. Cash used in operating activities was reduced by non-cash charges of $17.4 million relating to stock-based compensation expense of $18.1 million, depreciation of $1.1 million, and amortization of right-of-use asset of $0.1 million, offset by accretion of discounts, net on marketable securities of $1.8 million.

Cash used in operating activities during the six months ended June 30, 2025 was $70.4 million primarily driven by our net loss for the period of $76.9 million, and was also impacted by changes in operating assets and liabilities, which increased net working capital by $7.3 million. Cash used in operating activities was reduced by non-cash charges of $13.8 million relating to stock-based compensation expense of $16.8 million, accretion of discounts, net on marketable securities of $4.1 million, depreciation of $1.0 million, and amortization of right-of-use asset of $0.1 million.

Cash used in operating activities during the nine months ended September 30, 2026 was $163.3 million, primarily reflecting research and development and general and administrative expenses for the period of $162.2 million. Net income included a $1,348.1 million gain on the Sevasemten Sale, which was deducted in reconciling net income to operating cash flows because the related net cash proceeds are presented within investing activities.

Cash used in operating activities during the nine months ended September 30, 2025 was $105.2 million, primarily reflecting research and development and general and administrative expenses for the period of $135.4 million, partially offset by interest received .

1 unchanged paragraph

Cash provided by investing activities during the six nine months ended June September 30, 2026 amounted to $80.9 $140.6 million, primarily due to $217.7 the approximately $1,348.9 million in cash proceeds from the Sevasemten Sale completed on July 10, 2026, net of $47.2 million in transaction related costs paid. Additional increases were due to $314.3 million in maturities of marketable securities and $26.8 $45.3 million in sales of marketable securities, which were partially offset by $163.2 $1,567.5 million in purchases of marketable securities and $0.3 million for purchases of equipment.

Cash used in investing activities during the six nine months ended June September 30, 2025 amounted to $118.3 $82.6 million, due to $385.9 $452.9 million in purchases of marketable securities and $0.1 $0.2 million for purchases of equipment, which was partially offset by $229.1 $319.1 million in maturities of marketable securities and $38.7 $51.5 million in sales of marketable securities.

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Cash provided by financing activities during the six nine months ended June September 30, 2026 was $15.3 $30.2 million due to cash proceeds of $14.5 $29.4 million from the issuance of common stock upon exercise of stock options and $0.8 million in proceeds from the Company's 2021 Employee Stock Purchase Plan (2021 ESPP) .

Cash provided by financing activities during the six nine months ended June September 30, 2025 was $190.5 $192.1 million, due to cash proceeds of $200.0 million from the April 2025 underwritten registered direct offering, $2.5 $4.2 million in proceeds from the issuance of common stock upon exercise of stock options, and $0.6 million in proceeds from the Company's 2021 Employee Stock Purchase Plan (2021 ESPP), which was partially offset by $12.6 million for the payment of underwriting discounts and commissions and offering costs.

1 unchanged paragraph

On July 10, 2026, we completed the Sevasemten Sale and received $1,550 million in upfront cash proceeds. As a result, our available liquidity increased materially after June 30, 2026. In the quarter ending September 30, 2026, we expect to recognize a gain on the sale within other income, subject to final closing-date carrying values of the assets transferred and liabilities assumed, transaction costs, and the related income tax effects. We also expect our future operating expenses to be affected by the elimination of direct sevasemten program costs that will not continue following the sale, partially offset by costs and reimbursements associated with the Transition Services Agreement. Any contingent milestone payments will be recognized only if and when the applicable recognition criteria are met.

On July 10, 2026, we completed the Sevasemten Sale and received $1,396.1 million in upfront cash proceeds, with an additional $153.9 million deposited into escrow in accordance with the Sevasemten Purchase Agreement, for total expected initial proceeds of $1,550.0 million . As a result, cash, cash equivalents, and marketable securities increased to $1,743.9 million as of September 30, 2026 from $530.1 million as of December 31, 2025. For the three and nine months ended September 30, 2026, we recognized a gain of $1,348.1 million on the Sevasemten Sale. Research and development expenses for the three months ended September 30, 2026 decreased, primarily due to the elimination of direct sevasemten program costs that have not continued following the sale, partially offset by costs associated with the TSA. Any contingent milestone payments will be recognized only if and when the applicable recognition criteria are met.

1 unchanged paragraph

Based on our current operating plans, we may continue to require substantial additional capital to develop believe that our product candidates existing cash, cash equivalents and marketable securities will be sufficient to fund operations our planned operating expenses and capital expenditure requirements for at least the foreseeable next 12 months from the date of this Quarterly Report. Drug development and commercialization are capital intensive, and we may seek additional capital in the future to expand our development programs, prepare for commercialization or pursue strategic opportunities. On May 10, 2024, we filed an automatic shelf registration statement on Form S-3ASR that allows us to undertake various equity and debt offerings and entered into the Leerink Sales Agreement under which we may offer and sell shares of common stock, having aggregate sales proceeds of up to $175.0 million from time to time, through the Leerink ATM.

On May 31, 2026, the Company we entered into the Sevasemten Purchase Agreement, pursuant to which Servier acquired sevasemten and certain other related assets collectively constituting the Company's our muscular dystrophy program and assumed certain related liabilities for aggregate potential consideration of up to $2,650 $2,650.0 million. The transaction was completed on July 10, 2026, the Company completed the Sevasemten Sale receiving $1,550 and we received $1,396.1 million in upfront cash proceeds, and with an additional $153.9 million deposited into escrow in accordance with the Sevasemten Purchase Agreement, for total expected initial proceeds of $1,550.0 million. The Company is eligible to receive up to $1,100 $1,100.0 million in potential future milestone payments, including (a) a potential milestone payment upon achieving U.S. marketing approval for sevasemten for Becker muscular dystrophy in the amount of (i) $200 $200.0 million, in cash, payable in the event of an approved labelling including specified adult and adolescent populations or (ii) $100 $100.0 million in cash, payable in the event of an approved labelling including only specified adult populations (if (i) has not previously been achieved); (b) a potential milestone payment of $600 $600.0 million in cash, payable upon the achievement of U.S. marketing approval for sevasemten for Duchenne muscular dystrophy; and (c) a potential milestone payment of $300 $300.0 million in cash, payable upon the achievement of annual U.S. net sales of sevasemten products exceeding $550 $550.0 million. Achievement of these milestones depends on regulatory and commercial outcomes controlled by Servier, and we may not receive any milestone payments. On November 3, 2026, Servier announced that the pivotal GRAND CANYON study of sevasemten in Becker muscular dystrophy did not meet its primary or secondary endpoints. Servier is conducting further analysis of the study results and relevant prior clinical data.

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We do not currently have any long-term material capital requirements other than what will be required to fund operations for the foreseeable future and the amounts those disclosed on the below under contractual obligations and commitments. section below. In order to complete the process of Obtaining regulatory approval for our product candidates and to build building the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, them, if approved, will require significant resources, and we may require substantial seek additional funding to support those activities.

7 unchanged paragraphs

o the cost and timing of hiring new employees to support our continued growth;

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and 14 more changes in the filing

Market risk 1 change

We are exposed to market risk related to changes in interest rates. As of June September 30, 2026 and December 31, 2025, we had cash, cash equivalents and marketable securities of $460.7 $1,743.9 million and $530.1 million, respectively, primarily invested in U.S. Treasury securities, U.S. government agency securities, corporate debt securities, asset-backed securities, commercial paper, and money market accounts. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly because our investments are in short-term available-for-sale marketable securities. Our available-for-sale marketable securities are subject to interest rate risk and will fall in value if market interest rates increase. Due to the short-term duration of our investment portfolio and the low risk profile of our investments, an immediate 10% change in interest rates would not have a material effect on the fair market value of our investment portfolio. However, there can be no assurance that changes in interest rates will not have a material adverse impact on us in the future.

2 unchanged paragraphs

Controls and procedures 2 changes

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act) as of June September 30, 2026. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of June September 30, 2026 were effective at a reasonable assurance level in ensuring that information required to be disclosed by us in reports that we file or submit under the Exchange Act (i) is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission's rules and forms; and (ii) is accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely discussions decisions regarding required disclosure. We believe that a control system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the control system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.

There was no change in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred during the three and six nine months ended June September 30, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Risk factors 44 changes

4 unchanged paragraphs

● We have a limited operating history and while we are moving toward becoming a commercial-ready clinical-stage biopharmaceutical company with a limited operating history, some of our product candidates are early in development and we have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and likelihood of success and future viability.

● We have not generated any product revenue to date and, other than net income resulting from the gain on the Sevasemten Sale, have incurred significant net losses since our inception, and expect to continue to incur significant net losses for the foreseeable future.

27 unchanged paragraphs

● There is no guarantee that we will receive the milestone payments under the Sevasemten Purchase Agreement. (as defined below).

● We have discretion in the use of the proceeds from the Sevasemten Sale (as defined below) and our choices about the use of proceeds may be ineffective.

3 unchanged paragraphs

We have a limited operating history and while we are moving toward becoming a commercial-ready clinical-stage biopharmaceutical company with a limited operating history, some of our product candidates are early in development and we have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and likelihood of success and future viability.

We are a late-stage clinical clinical-stage biopharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. We are developing precision medicines for cardiovascular diseases which is an unproven and highly uncertain undertaking and involves a substantial degree of risk. We commenced operations in 2017, and while we are moving toward becoming a commercial-ready biopharmaceutical company, we have no products approved for commercial sale, and have not generated any product revenue. In April 2024, We began enrolling expect to initiate a multipart Phase 2 3 clinical trial with our product candidate EDG-7500 for people with hypertrophic cardiomyopathy (HCM) and in September 2025, the fourth quarter of 2026, and we have initiated a Phase 1 2 clinical trial of healthy adults with our product candidate EDG-15400 in adults with future disease target of symptomatic heart failure with preserved ejection fraction (HFpEF) who have a left ventricular ejection fraction (LVEF) of at least 50% . We have not yet initiated clinical trials for any other product candidate, including product candidates from our EDG-003 cardiometabolic discovery program. Since our inception in 2017, we have devoted substantially all of our focus and financial resources to discovering, identifying and developing potential product candidates, including advancing our development programs, conducting preclinical studies of our product candidates and initiating clinical trials, organizing and staffing our company, business planning, raising capital and securing related intellectual property rights.

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We have not generated any product revenue to date and, other than net income resulting from the gain on the Sevasemten Sale, have incurred significant net losses since our inception, and expect to continue to incur significant net losses for the foreseeable future.

Other than net income resulting from the gain on the Sevasemten Sale, we have incurred significant net losses since our inception, have not generated any product revenue to date and have financed our operations principally through private placements of our convertible preferred stock and public offerings of our common stock. Our net loss income was $57.3 $1,166.2 million and $106.3 $1,059.8 million for the three and six nine months ended June September 30, 2026, respectively, and as of June September 30, 2026, we had an accumulated deficit retained earnings of $652.7 $513.4 million, primarily driven by the gain recognized from the Sevasemten Sale. We are advancing EDG-7500 and EDG-15400 in clinical development. Our other programs, including EDG-003, are in preclinical discovery and research stages. As a result, we expect that it will be a couple of several years, if ever, before we receive approval to commercialize a product and generate revenue from product sales. Even if we succeed in receiving marketing approval for and commercializing one or more of our approved product candidates, we expect that we will continue to incur substantial research and development and other expenses in order to discover, develop and market additional potential products.

We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. For example, we anticipate that our general and administrative expenses will increase in the future as we scale our organization to support clinical advancement, regulatory readiness, and future commercial planning activities. The net losses we incur may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may not be a good indication of our future performance, particularly since we expect our expenses to increase if and when our product candidates progress through clinical development as product candidates in later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to the increased size and duration of later-stage clinical trials. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Net income recognized in the three and nine months ended September 30, 2026 is not indicative of future operating performance because it includes the gain recognized on the Sevasemten Sale. Our prior losses and expected future losses have had and will continue to have an adverse effect on our working capital, our ability to fund the development of our product candidates and our ability to achieve and maintain profitability and the performance of our stock.

On July 10, 2026, we completed the sale of our sevasemten muscular dystrophy program to Servier and received $1,550 million in upfront cash consideration. While the transaction Sevasemten Sale significantly strengthened our capital position, we expect to continue to incur substantial operating losses as we advance EDG-7500, EDG-15400 and our other cardiovascular programs. Our future capital requirements will depend on numerous factors, our operating plans, including the scope and timing of our clinical development timelines, programs, commercialization activities and potential strategic opportunities, as well as regulatory requirements, manufacturing activities, commercialization strategies and potential business development opportunities and other factors. In addition, future milestone payments under the Servier transaction Sevasemten Purchase Agreement are contingent upon the achievement of specified development, regulatory and commercial milestones and may never be received.

1 unchanged paragraph

Our business depends entirely on the successful discovery, development, regulatory approval and commercialization of product candidates. We have no products approved for commercial sale and do not anticipate generating any revenue from product sales for the next couple of several years, if ever. Our ability to generate revenue and achieve profitability depends significantly on our ability, or any future collaborator's ability, to achieve several objectives, including:

27 unchanged paragraphs

As of June September 30, 2026, we had $460.7 $1,743.9 million in cash, cash equivalents and marketable securities. We also received $1,550 million in upfront cash consideration and can potentially receive up to $1,100 million in additional milestone payments in connection with the Sevasemten Sale. We expect our current cash, cash equivalents and marketable securities will be sufficient to fund our current operating plan for at least the next 12 months. The upfront proceeds from the Sevasemten Sale, combined with existing cash, cash equivalents and marketable securities, significantly strengthen our capital position and are expected to support advancement of EDG-7500 and our cardiovascular pipeline; however, our operating plans may change and we may seek or require additional capital. On May 10, 2024, we filed an automatic shelf registration statement on Form S-3ASR that allows us to undertake various equity and debt offerings. We additionally filed a prospectus supplement to the shelf registration statement and entered into a sales agreement with Leerink Partners LLC (Leerink Sales Agreement) on May 10, 2024, under which we 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). Pursuant to the automatic shelf registration statement, on April 3, 2025, we closed an underwritten registered direct offering of 9,935,419 shares of our common stock for net proceeds of $187.1 million after deducting underwriting discounts and commissions and offering expenses. We have not yet offered or sold any shares of common stock related to the Leerink ATM.

19 unchanged paragraphs

We may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. We may also seek additional capital in the future to support strategic opportunities, business development activities, commercialization initiatives or expanded development programs. In the event that we would need to obtain additional funding, our ability to raise or access capital may be affected by macroeconomic events and disruptions to the U.S. banking and financial sectors and adequate financing may not be available to us on acceptable terms, or at all. Failures of banks and other financial institutions, such as Silicon Valley Bank in March 2023, or issues in the broader U.S. financial system may impact the broader capital markets, and in turn, may impact our ability to access those markets. Further, a tightening of credit markets and lending standards could it make it more difficult for us to raise capital through either debt or equity offerings on commercially reasonable terms or at all.

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The Sevasemten Sale has generated, and may in the future generate, substantial taxable income. Although we have net operating loss carryforwards and other tax attributes, our ability to use those attributes may be limited under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the Code) (as further described below) and similar state rules. As a result, the Sevasemten Sale may result in material cash tax obligations, and the amount of any such obligations may differ from our estimates as the transaction accounting and related tax provision are finalized.

Our net operating loss (NOL) carryforwards may be unavailable to offset future taxable income because of restrictions under U.S. tax law. Our federal NOLs generated in tax years beginning after December 31, 2017 may be carried forward indefinitely, but for taxable years beginning after December 31, 2020, the deductibility of federal NOLs generated in tax years beginning after December 31, 2017 is limited to 80% of our current year taxable income. Our state NOLs may be subject to similar or different limitations. As of December 31, 2025, we had available federal NOL carryforwards of approximately $319.7 million, of which $318.5 million do not expire, and state NOL carryforwards of approximately $333.3 million, of which $32.7 million do not expire. We expect to use substantially all of these NOLs to offset taxable income arising from the Sevasemten Sale.

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We are subject to tax laws, regulations, and policies of several taxing jurisdictions. Changes in tax laws, as well as other factors, could cause us to experience fluctuations in our tax obligations and effective tax rates and otherwise adversely affect our tax positions and/or our tax liabilities. Further, many countries, and organizations such as the Organization for Economic Cooperation and Development (the OECD) have proposed implementing changes to existing tax laws, including a proposed 15% global minimum tax (Pillar Two) that has been implemented by several countries in 2024 and is being considered for implementation by other jurisdictions. On January 5, 2026, the OECD announced a "side-by-side" elective safe harbor that exempts U.S.-parented multinational entities from some of the Pillar Two rules (including the 15% global minimum tax) for fiscal years beginning on or after January 1, 2026. Any of these developments or changes in U.S. federal or state or non-U.S. tax laws or tax rulings could adversely affect our effective tax rate and our operating results.

"side-by-side" elective safe harbor that exempts U.S.-parented multinational entities from some of the Pillar Two rules (including the 15% global minimum tax) for fiscal years beginning on or after January 1, 2026. Any of these developments or changes in U.S. federal or state or non-U.S. tax laws or tax rulings could adversely affect our effective tax rate and our operating results.

44 unchanged paragraphs

Our future operating results are dependent on our ability to successfully develop, obtain regulatory approval for and commercialize EDG-15400 in adults with future disease target of symptomatic HFpEF who have an LVEF of at least 50%, product candidates from our EDG-003 research program currently focused on cardiometabolic indications, and our lead product candidate EDG-7500 . However, research and development related to new product candidates is inherently risky. A product candidate can unexpectedly fail at any stage of preclinical and/or clinical development. The historical failure rate for product candidates is high due to risks relating to safety, efficacy, clinical execution, changing standards of medical care and other unpredictable variables. The results from preclinical testing or early clinical trials of a product candidate may not be predictive of the results that will be obtained in later stage clinical trials of the product candidate.

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For EDG-7500 trials, we completed the Phase 1 trial in healthy subjects and our multipart Phase 2 trial (CIRRUS-HCM) in patients with oHCM and nHCM, and for EDG-15400 trials, we completed the Phase 1 trial in healthy subjects. However, we may experience difficulty with enrollment of patients in a Phase 3 trial of EDG-7500 and Phase 2 trial of EDG-15400 (EQUINOX-HFpEF).

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With EDG-7500, we expect to face competition from existing products and products in development. Current first-line pharmaceutical treatment for patients with oHCM and nHCM consists of non-vasodilating beta blockers and non-dihydropyridine calcium channel blockers. Commonly prescribed beta-blockers are atenolol, propranolol, and metoprolol. Verapamil and diltiazem are calcium channel blockers used in the treatment of symptomatic oHCM and nHCM. For oHCM patients who remain symptomatic, a sodium channel blocker with negative ionotropic inotropic drug properties, typically disopyramide (Norpace marketed by Pfizer or a generic form) and/or a cardiac myosin inhibitor (CMI) (Camzyos marketed by Bristol-Myers Squibb (BMS) or Myqorzo marketed by Cytokinetics), may also be added.

In the field of emerging treatments for HCM, competitors include BMS, Cytokinetics and Braveheart, each of which has advanced or is advancing a CMI for the treatment of symptomatic NYHA Class II-III oHCM and nHCM. BMS received approval for oHCM and commercialized Camzyos (mavacamten) in the US in 2022 and is now approved and marketed in Europe and countries across five continents. In late 2025 and early 2026, Cytokinetics received approval of Myqorzo (aficamten) in the US, Europe and certain Asian countries, also for the treatment of oHCM. BMS reported negative results from its Phase 3 nHCM trial of mavacamten in early 2025 but plans to initiate another Phase 3 nHCM trial in the second half of 2026. In 2026, Cytokinetics announced positive results from its Phase 3 trial of aficamten in nHCM. Cytokinetics and BMS are also developing their respective CMIs in pediatric oHCM patients; in September 2026, BMS announced a target review date under the Prescription Drug User Fee Act (PDUFA) approval of September 30, 2026 Camzyos for the FDA-accepted sNDA for Camzyos treatment of symptomatic NYHA II-III oHCM in adolescents. with oHCM. Braveheart Bio announced results from its Phase 2 oHCM and nHCM of HRS/BHB-1893 in March 2026 and plans to initiate global Phase 3 studies in oHCM and nHCM in the second half of 2026 and 2027, respectively.

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"real-time" release of newly issued Complete Response Letters associated with withdrawn or abandoned applications, if applicable to any of our product candidates, can materially impact our competitive advantage and intellectual property.

Further, under the new leadership at the HHS under the current administration, agency reorganization, mass layoffs due to the reduction in force initiative and other measures implemented by the Department of Government Efficiency may impact the normal operations of the FDA as well as other federal agencies. FDA may lack adequate staff and resources to meet current review, approval, and inspection schedules, which could delay our anticipated timelines. In January 2025, an executive order entitled "Unleashing Prosperity Through Deregulation", was issued which calls for at least 10 existing regulations to be repealed whenever an executive department or agency publicly proposes for notice and comment or otherwise promulgates a new regulation. Recent developments at the FDA include implementation of Elsa, a generative AI tool, across all centers at the agency, announcement of a plan to phase out animal testing for monoclonal antibodies and certain other drugs, and the announcement of a new Commissioner's National Priority Voucher program to companies supporting certain U.S. national health priorities and interests. FDA has also increased its scrutiny of foreign drug manufacturing facilities and other contractors based in China, especially with respect to the transfer of biological materials, genetic data, and other sensitive data of American patients to parties located in China. FDA's "real-time" release of newly issued Complete Response Letters associated with withdrawn or abandoned applications, if applicable to any of our product candidates, can materially impact our competitive advantage and intellectual property.

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Even if we are successful in obtaining orphan drug designation, we may not be able to obtain or maintain orphan drug exclusivity for that product candidate. We may not be the first to obtain marketing approval of any product candidate for which we have obtained orphan drug designation for the orphan-designated indication due to the uncertainties associated with developing pharmaceutical products. In addition, exclusive marketing rights in the

Even if we are successful in obtaining orphan drug designation, we may not be able to obtain or maintain orphan drug exclusivity for that product candidate. We may not be the first to obtain marketing approval of any product candidate for which we have obtained orphan drug designation for the orphan-designated indication due to the uncertainties associated with developing pharmaceutical products. In addition, exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially defective or if we are unable to ensure that we will be able to manufacture sufficient quantities of the product to meet the needs of patients with the rare disease or condition. Further, even after obtaining orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties may be approved for the same condition. Even after an orphan drug is approved, the FDA can subsequently approve the same drug with the same active moiety for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care or the manufacturer of the product with orphan exclusivity is unable to maintain sufficient product quantity. Orphan drug designation neither shortens the development time or regulatory review time of a drug nor gives the product candidate any advantage in the regulatory review or approval process or entitles the product candidate to priority review. In January 2023, the FDA published a notice in the Federal Register to clarify that while the agency complies with the court's order in Catalyst , FDA intends to continue to apply its longstanding interpretation of the regulations to matters outside of the scope of the Catalyst order – that is, the agency will continue tying the scope of orphan-drug exclusivity to the uses or indications for which a drug is approved, which permits other sponsors to obtain approval of a drug for new uses or indications within the same orphan designated disease or condition that have not yet been approved. The Consolidated Appropriations Act of 2026, signed into law in February 2026, codified this longstanding FDA interpretation of the Orphan Drug Act, allowing the FDA to approve multiple versions of the same orphan drug for different subindications and subpopulations.

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Where possible, we plan to pursue accelerated development strategies in areas of high unmet need. We may seek an accelerated approval pathway for our one or more of our product candidates. Under the accelerated approval provisions in the Federal Food, Drug, and Cosmetic Act, and the FDA's implementing regulations, the FDA may grant accelerated approval to a product candidate designed to treat a serious or life-threatening condition that provides meaningful therapeutic benefit over available therapies upon a determination that the product candidate has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as irreversible morbidity or mortality. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage but is a clinically important improvement from a patient and public health perspective. If granted, accelerated approval is usually contingent on the sponsor's agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the drug's clinical benefit. If such post-approval studies fail to confirm the drug's clinical benefit, the FDA may withdraw its approval of the drug. The Food and Drug Omnibus Reform Act reformed the accelerated approval pathway, such as requiring the FDA to specify conditions for post-approval study requirements and setting forth procedures for the FDA to withdraw a product on an expedited basis for non-compliance with post-approval requirements.

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Moreover, there has been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products, which has resulted in several congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. For example, the American Rescue Plan Act of 2021 eliminated the statutory cap on Medicaid Drug Rebate Program rebates that manufacturers pay to state Medicaid programs. Elimination of this cap may require pharmaceutical manufacturers to pay more in rebates than it receives on the sale of products, which could have a material impact on our business. In August 2022, Congress passed the Inflation Reduction Act of 2022, which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes. Only high-expenditure single-source drugs that have been approved for at least 7 years (11 years for single-source biologics) can qualify for negotiation, with the negotiated price taking effect two years after the selection year. For 2026, CMS selected 10 high-cost Medicare Part D drugs in 2023 and the negotiated maximum fair price for each drug has been announced. CMS has selected 15 additional Medicare Part D drugs for negotiated maximum fair pricing in 2027. For 2028, up to an additional 15 drugs, which may be covered under either Medicare Part B or Part D, will be selected, and for 2029 and subsequent years, up to 20 additional Part B or Part D drugs will be selected. Various industry stakeholders have initiated lawsuits against the federal government asserting that the price negotiation provisions of the Inflation Reduction Act are unconstitutional. In June January 2026, the CMS issued a proposed rule that would codify policies established in guidance documents for launched the Medicare Drug Price Negotiation Program GENEROUS Model (GENErating cost Reductions fOr initial price applicability year 2029 and beyond. CMS plans to release guidance to implement policies related U.S. Medicaid Model), which aims to the effectuation of the MFP ensure fair and reasonable drug prices for the Medicare Medicaid through CMS-led negotiations with drug Price Negotiation Program manufacturers. Under the GENEROUS Model, manufacturers will provide supplemental rebates to participating states for 2028, consistent drugs included in the model to align Medicaid net prices with what certain other countries pay. The Inflation Reduction Act. GENEROUS Model is voluntary for manufacturers and states.

Further, the current administration has issued executive orders focused on decreasing prescription drug prices, including directing the Secretary of Health and Human Services to establish a mechanism through which American patients can buy drugs directly from manufacturers who sell at a most-favored-nation price and directing the U.S. Trade Representative and Secretary of Commerce to take action to ensure foreign countries are not engaged in practices that purposefully and unfairly undercut market prices and drive price hikes in the United States. In November 2025, October 2026, CMS announced a voluntary initiative called published the GENEROUS Model (GENErating cost Reductions Global Benchmark for U.S. Medicaid Efficient Drug Pricing (GLOBE) Model Final Rule, which will implement a mandatory Medicare Part B five-year demonstration payment model that will require manufacturers of certain high-spend Part B drugs and biologicals to introduce pay rebates to CMS tied to international drug prices for those products. The option final rule added exclusions for orphan-only drugs, cellular and gene therapy products, and plasma-derived products, and delayed the start of most-favored-nation pricing to the Medicaid program, whereby a drug manufacturer may voluntarily offer supplemental rebates first performance year to participating state Medicaid programs April 1, 2027. CMS also noted that it intends to waive GLOBE's mandatory participation requirements for a manufacturers covered outpatient drugs. in any calendar quarter during which they are participating in the GENEROUS Model. The GLOBE Model final rule is subject of ongoing litigation, which can impact its implementation. Government agreements with pharmaceutical companies and other measures that use most-favored-nation pricing targets for prescription drugs, including the use of international pricing reference to set drug prices in the United States, or that increase generic and biosimilar drug entry sooner than expected can have a material adverse effect on our industry, ability to set adequate pricing for new drugs to recover R&D costs, ability to attract potential investors and potential buyers in the future. Additionally, the OBBB Act includes provisions that will impact the United States healthcare system in various ways, including by cuts to Medicaid and introducing new participant work and eligibility requirements for Medicaid coverage, which are expected to significantly change the administration and applicability of Medicaid coverage. The OBBB Act also expanded the orphan drug exemptions under the Medicare Price Negotiation Program, including an amendment to exclude orphan designated drugs for one or more rare diseases or conditions, instead of only one disease/condition, with the initial price applicability year 2028 and after, from Medicare price negotiations, and providing that the time for measuring a former orphan drug's eligibility for Medicare price negotiations will be calculated from the first day after the date of FDA approval for a non-orphan disease or condition, or an approval for which the drug does not have orphan drug designation. The expansion of the exemptions for orphan designated drugs from the Medicare Drug Price Negotiation Program is expected to provide greater incentives for the development of drugs for orphan diseases and conditions which could potentially increase our competition. We cannot predict the full impact of the OBBB Act, executive orders, and new laws focused on reducing prescription drug prices or increasing domestic drug manufacturing capacity, or other measures that may be implemented by the current administration related to drug pricing, drug supply chain and manufacturing in the United States. The impact of ongoing and future judicial challenges as well as future legislative, executive, and administrative actions and any future healthcare measures and agency rules implemented by the current administration on us and the pharmaceutical industry as a whole is unclear. The implementation of cost containment measures, including the prescription drug provisions under the Inflation Reduction Act, as well as other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved.

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In the United States, a broad variety of data protection laws and regulations may apply to our activities such as state data breach notification laws, state personal data privacy laws (for example, the California Consumer Privacy Act of 2018 (CCPA)), state health information privacy laws, and federal and state consumer protection laws. A range of enforcement agencies exist at both the state and federal levels that can enforce these laws and regulations. For example, the CCPA requires covered businesses that process personal information of California residents to disclose their data collection, use and sharing practices. Further, the CCPA provides California residents with certain data privacy rights (including the ability to opt out of certain disclosures of personal data), imposes operational requirements for covered businesses, provides for civil penalties for violations as well as a private right of action for data breaches and statutory damages (that is expected to increase data breach class action litigation and result in significant exposure to costly legal judgments and settlements). Aspects of the CCPA and its interpretation and enforcement remain uncertain. In addition, the CCPA was expanded on January 1, 2023, when the California Privacy Rights Act of 2020 (CPRA) became operative. The CPRA, among other things, gives California residents the ability to limit use of certain sensitive personal information, establishes restrictions on the retention of personal information, expand the types of data breaches subject to the CCPA's private right of action, provides for increased penalties for CPRA violations concerning California residents under the age of 16, and establishes a California Privacy Protection Agency to implement and enforce the legislation. Although there are limited exemptions for clinical trial data under the CCPA, the CCPA and other similar laws could impact our business activities, depending on their interpretation. Additionally, numerous other state legislatures have enacted or are currently contemplating, and may pass, their own data privacy and security laws, with potentially greater penalties and more rigorous compliance requirements relevant to our business. Many of these laws are comprehensive privacy statutes that impose obligations similar to the CCPA. For example, Colorado enacted a Colorado Privacy Act (CPA) in June 2021 that went into effect on July 1, 2023, with enforcement commencing on the same date. The Colorado Attorney General released its rules implementing the CPA on March 15, 2023, and since has amended these rules on multiple occasions. Connecticut, Utah and Virginia have also enacted legislation similar to the CCPA and the CPA that took effect in 2023; Florida, Montana, Oregon and Texas have enacted similar legislation that took effect in 2024; Delaware, Iowa, Maryland, Minnesota, New Hampshire, New Jersey, Nebraska and Tennessee have enacted similar legislation that took effect in 2025; Indiana, Kentucky and Rhode Island have enacted similar legislation that has taken effect in 2026; Alabama, Louisiana, and Oklahoma have enacted similar legislation that will take effect in 2027; and Vermont has enacted similar legislation that takes effect in 2028. The U.S. government also has instituted rules, effective April 8, 2025, that prohibit or restrict transactions involving certain types and amounts of sensitive data between U.S. persons and foreign persons associated with specific countries of concern, including China. Among other things, these rules require U.S. businesses to seek assurances from certain foreign parties with which they share sensitive data (under certain types of agreements) that those parties will not further share that data with parties in countries of concern. Further, other states have enacted laws that cover certain aspects of the collection, use, disclosure, and/or other processing of health information, such as Washington's My Health, My Data Act, which, among other things, provides for a private right of action.

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The Sevasemten Sale resulted in the separation or transfer of certain employees and may require us to reallocate responsibilities among remaining personnel while continuing to recruit and retain employees needed to advance our cardiovascular pipeline. Following the sale of sevasemten, we had 127 133 full-time employees. Of these employees, 94 98 are engaged in research or product development and clinical activities. In order to successfully implement our development and commercialization plans and strategies, we expect to need additional managerial, operational, sales, marketing, financial and other personnel. Future growth would impose significant added responsibilities on members of management, including:

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We, and our CROs, like other companies operating in today's environment, are increasingly dependent on information systems, services and infrastructure, and information systems, services, and infrastructure owned, operated or maintained by third parties, to operate our business. In the ordinary course of our business, we collect, create, generate, process, transmit and store large amounts of sensitive information, including personal information, proprietary information such as trade secrets, and other sensitive data. It is critical that we do so in a manner designed to maintain the confidentiality, integrity and availability of our information systems and the information contained therein. We have incurred costs to establish a cybersecurity risk management program, including through the implementation of security measures in an effort to protect systems that store our information. However, despite the implementation of those security measures and the implementation of our cybersecurity risk management program, given the size and complexity and the increasing amounts of information maintained on our information technology systems, and those of our third-party CROs, other contractors (including sites performing our clinical trials), service providers, suppliers, and consultants, these systems are potentially vulnerable to breakdown or other damage or interruption from service interruptions, system malfunction, technical errors, natural disasters, terrorism, war and telecommunication and electrical failures, as well as security breaches and incidents from inadvertent or intentional actions by our employees, contractors, consultants, service providers, business partners, and/or other third parties, or from cyber-attacks by malicious third parties (including supply chain cyber-attacks or the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering and other means to affect service reliability and threaten the confidentiality, integrity and availability of information), which may compromise the confidentiality, integrity, or availability of our information systems or the information contained therein, or otherwise availability or lead to the loss, destruction, alteration, prevention of access to, disclosure, or dissemination of, or damage or unauthorized access to, our data (including trade secrets or other confidential information, intellectual property, proprietary business information, and personal information) or data that is processed or maintained on our behalf, or other assets, which could result in financial, legal, business and reputational harm to us. We, our CROs, and other vendors that we work with have experienced cybersecurity incidents in the past (including one of our vendors in 2026 and CROs of ours in 2025, 2023, and 2019) and we cannot eliminate the risk that we, our CROs, and other vendors will experience them in the future.

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Also, our CDMOs' and suppliers' facilities are located in multiple locations where other natural disasters or similar events which could severely disrupt our operations, could expose us to liability and could have a material adverse effect on our business. The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses.

Our facilities and many of our personnel are located in Boulder, Colorado. We have not undertaken a systematic analysis of the potential consequences to our business and financial results from a major flood, blizzard, fire, earthquake, power loss, terrorist activity, pandemics or other disasters and do not have a recovery plan for such disasters. In addition, we do not carry sufficient insurance to compensate us for actual losses from interruption of our business that may occur, and any losses or damages incurred by us could harm our business. Also, our CDMOs' and suppliers' facilities are located in multiple locations where other natural disasters or similar events which could severely disrupt our operations, could expose us to liability and could have a material adverse effect on our business. The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses.

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In particular, there is currently significant uncertainty about the future relationship between the United States and various other countries, including China, with respect to trade policies, treaties, tariffs, taxes, any retaliatory actions in respect thereto, and other limitations on cross-border operations. The U.S. government has and continues to make significant additional changes in U.S. trade policy and may continue to take future actions, including the impact of changes in the U.S. government administration and policy positions , that could negatively impact U.S. trade and our business. For example, legislation in Congress known as the BIOSECURE Act was enacted in December 2025 as part of the 2026 National Defense Authorization Act, and places limitations on certain interactions with certain Chinese and other biotechnology firms that may pose a threat to United States national security; additional proposals have been raised regarding possible executive actions to further limit those Chinese service providers' ability to engage in business in the United States. In addition, between February 2025 and February 2026, the U.S. administration imposed additional tariffs of 10% - 145% on many products imported from China citing authorities provided for in the International Emergency Economic Powers Act (IEEPA). These additional U.S. tariffs implemented under IEEPA were rescinded on February 24, 2026, following a Supreme Court decision invalidating the use of IEEPA to authorize these tariffs, but the U.S. government subsequently implemented a "temporary import surcharge" of 10% on many of the same imports between February 24, 2026 and July 24, 2026, under authorities provided for in Section 122 of the Trade Act of 1974. Upon expiration of the Section 122 temporary import surcharge on July 24, 2026, the U.S. government implemented tariffs of up to 10% or 12.5% on imported commodities from 60 U.S. trading partners, with certain items (including certain chemicals used for pharmaceutical applications) excepted, under authorities provided under Section 301 of the Trade Act of 1974, following a determination by the U.S. Trade Representative that these trading partners insufficiently enforce forced labor laws. The United States has also implemented tariffs of up to 100% under Section 232 of the Trade Expansion Act of 1962 on certain patented pharmaceutical products and APIs. In response to these and other actual and threatened tariff actions, certain U.S. trading partners have from time to time imposed and/or threatened retaliatory tariffs or other trade controls. These or other tariffs, actual or proposed legislation, or similar laws and regulations in the future, including changes to implemented bilateral trade deals between the U.S. and China, could adversely impact our current or future third-party arrangements with certain companies, including those in China or Chinese-owned U.S. companies, which could delay or impact our clinical trials and consequently delay or obstruct successful commercialization of our product candidates. We cannot predict what actions may ultimately be taken with respect to trade relations between the United States and China or other countries, what products and services may be subject to such actions or what actions may be taken by the other countries in retaliation. If we are unable to obtain or use services from existing service providers or become unable to export or sell our products to any of our customers or service providers, our business, liquidity, financial condition, and/or results of operations would be materially and adversely affected.

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Although no third-party has asserted a claim of patent infringement against us as of the date of this periodic report, others may hold proprietary rights that could prevent our product candidates from being marketed. While we believe that this patent and pending any such patent applications will would be difficult to enforce and that we would have valid defenses to these claims of patent infringement, we cannot be certain that we would prevail in any dispute and we cannot be certain how an adverse determination would affect our business.

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Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the marketplace. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or other legal proceedings relating to our intellectual property rights, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation or other proceedings.

Even if resolved in our favor, litigation or other legal proceedings relating to our intellectual property rights may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the marketplace. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or other legal proceedings relating to our intellectual property rights, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation or other proceedings.

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We would face significant competition in seeking appropriate collaborators and the negotiation process is time-consuming and complex. Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator's resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator's evaluation of a number of factors. Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA, EMA or comparable foreign regulatory authorities, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing drugs, the existence of uncertainty with respect to our ownership of intellectual property and industry and market conditions generally. The potential collaborator may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such collaboration could be more attractive than the one with us for our product candidate. Further, we may not be successful in our efforts to establish a collaboration or other alternative arrangements for product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view them as having the requisite potential to demonstrate safety and efficacy.

The potential collaborator may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such collaboration could be more attractive than the one with us for our product candidate. Further, we may not be successful in our efforts to establish a collaboration or other alternative arrangements for product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view them as having the requisite potential to demonstrate safety and efficacy.

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There is no guarantee that We will may not receive the milestone payments under the Sevasemten Purchase Agreement.

On July 10, 2026, Servier Pharmaceuticals LLC and Les Laboratoires Servier (Servier) acquired sevasemten and certain other related assets collectively constituting our muscular dystrophy program and assumed certain related liabilities for aggregate potential consideration of up to $2,650 $2,650.0 million (Sevasemten Sale), pursuant to an Asset Purchase Agreement between us and Servier dated May 31, 2026 (Sevasemten Purchase Agreement). The up to $2,650 $2,650.0 million of aggregate potential consideration consists of $1,550 $1,396.1 million in upfront cash already paid at closing, proceeds received upon close of the Sevasemten Sale, with an additional $153.9 million deposited into escrow in accordance with the Sevasemten Purchase Agreement, for total expected initial proceeds of $1,550.0 million, and up to $1,100 $1,100.0 million in potential future milestone payments that are subject to certain conditions, risks and uncertainties, including (a) a potential milestone payment upon achieving U.S. marketing approval for sevasemten for Becker muscular dystrophy in the amount of (i) $200 $200.0 million, in cash, payable in the event of an approved labelling including specified adult and adolescent populations or (ii) $100 $100.0 million in cash, payable in the event of an approved labelling including only specified adult populations (if (i) has not previously been achieved); (b) a potential milestone payment of $600 $600.0 million in cash, payable upon the achievement of U.S. marketing approval for sevasemten for Duchenne muscular dystrophy; and (c) a potential milestone payment of $300 $300.0 million in cash, payable upon the achievement of annual U.S. net sales of sevasemten products exceeding $550 $550.0 million. U.S. marketing approval for sevasemten for Becker muscular dystrophy or Duchenne muscular dystrophy and sales of sevasemten products in the U.S. are subject to various risks and uncertainties, many of which are outside of our control. The achievement of the milestones depends on, among other things, the results of clinical trials of sevasemten. On November 3, 2026, Servier announced that the pivotal GRAND CANYON study of sevasemten in Becker muscular dystrophy did not meet its primary or secondary endpoints, and there Servier is no guarantee that conducting further analysis of the study results and relevant prior clinical data. Such development could prevent the achievement of one or more of the milestones. Accordingly, we will may not receive any of the milestone payments. If we do not receive any of the milestone payments, our business, financial condition, results of operations and prospects may be adversely affected.

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We plan to use the proceeds that we received at the closing of the Sevasemten Sale and may receive as any milestone payments for working capital and general corporate purposes, in connection with our continued business, which is focused on our cardiovascular pipeline. We expect to use the upfront proceeds received at closing, together with our existing cash, cash equivalents and marketable securities, for working capital and general corporate purposes, including advancing EDG-7500, EDG-15400 and our EDG-003 cardiometabolic discovery program, satisfying transaction-related tax and other obligations. We will have broad discretion in the application of the proceeds from the Sevasemten Sale and our planned use of proceeds described above may not improve or enhance our business, financial condition, results of operations or prospects. An ineffective use of proceeds may have a material adverse effect on business, financial condition, results of operations and prospects.

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As of June September 30, 2026, our executive officers, directors, affiliated holders of 5% or more of our capital stock and their respective affiliates beneficially owned approximately 21.6% 21.5% of our outstanding common stock. These stockholders, acting together, may be able to control matters requiring stockholder approval. For example, they may be able to control elections of directors, amendments of our organizational documents or approval of any merger, sale of assets or other major corporate transactions. This concentration of ownership control may delay, discourage or prevent a change of control, including unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders, entrench our management and board of directors or delay or prevent a merger, consolidation, takeover or other business combination involving us that other stockholders may desire. The interests of this group of stockholders may not always coincide with your interests or the interests of other stockholders and they may act in a manner that advances their best interests and not necessarily those of other stockholders, including seeking a premium value for their common stock, and might affect the prevailing market price for our common stock.

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Our amended and restated certificate of incorporation and amended and restated bylaws contains contain provisions that could depress the market price of our common stock by acting to discourage, delay or prevent a change in control of our company or changes in our management that the stockholders of our company may deem advantageous. In addition, because our board of directors is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. These provisions, among other things:

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Unregistered sales of stock 3 changes

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Use of Proceeds from Follow-On Offering

On September 16, 2022, we completed a follow-on offering pursuant to a shelf registration statement on Form S-3 (File No. 333-264083) with the SEC that became effective on May 5, 2022, and issued 13,372,093 shares of our common stock at a price to the public of $10.32 per share, including 1,744,186 shares of common stock issued in connection with the full exercise by the underwriters of their options to purchase additional shares of common stock. The aggregate gross proceeds from the follow-on offering were $138.0 million. After deducting underwriting discounts and commissions of $8.3 million and offering costs of $0.5 million, the net proceeds from the follow-on offering were approximately $129.2 million.

There has been no material change in the use of proceeds from our follow-on offering as described in our final prospectus filed with the SEC on September 14, 2022 pursuant to Rule 424(b)(5). We invested the funds received in interest-bearing investment-grade securities.

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Exhibits 4 changes

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Asset Purchase Agreement

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# Certain confidential information contained in this exhibit has been omitted because it is both (i) not material; and (ii) the type that the registrant customarily and actually treats as private or confidential.

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Date: August 6, 2026

Date: November 4, 2026

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