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DESCRIPTION OF BUSINESS
9 Months Ended
Sep. 30, 2026
DESCRIPTION OF BUSINESS  
DESCRIPTION OF BUSINESS

NOTE 1  DESCRIPTION OF BUSINESS

Organization and Description of Business

Edgewise Therapeutics, Inc. (the Company) is a clinical-stage biopharmaceutical company focused on advancing therapies for people living with 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). 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.

Risks and Uncertainties

The board of directors of the Company discusses with management macroeconomic and geopolitical developments, including inflation, instability in the banking and financial services sector, tightening of the credit markets, the impact of changes in the U.S. government administration and policy positions, international conflicts, public health pandemics, cybersecurity, sanctions, and changes in tariffs so that the Company can be prepared to react to new developments as they arise. The board of directors and the management of the Company are carefully monitoring these developments and the resulting economic impact on its financial condition and results of operations.

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Liquidity and Capital Resources

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.

On May 10, 2024, the Company filed an automatic shelf registration statement on Form S-3ASR that allows the Company to undertake various equity and debt offerings. Additionally, on May 10, 2024, the Company filed a prospectus supplement to the shelf registration statement and entered into a sales agreement with Leerink Partners LLC (Leerink Sales Agreement) under which the Company may offer and sell shares of common stock, having aggregate sales proceeds of up to $175.0 million from time to time, through an “at the market offering” program (Leerink ATM) under which Leerink Partners LLC will act as sales agent. The Company has not yet offered or sold any shares of common stock related to the Leerink ATM.

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On April 3, 2025, the Company closed an underwritten registered direct offering of 9,935,419 shares of common stock at a public offering price of $20.13 per share (April 2025 Offering). The aggregate gross proceeds from the April 2025 Offering were $200.0 million, and the net proceeds were $187.1 million, after deducting underwriting discounts and commissions of $12.0 million and offering expenses of $0.9 million.

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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) $200.0

million, in cash, payable in the event of an approved labelling including specified adult and adolescent populations or (ii) $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 $600.0 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 $300.0 million in cash, payable upon the achievement of annual U.S. net sales of sevasemten products exceeding $550.0 million. Together, the total expected initial proceeds and potential future milestone payments constitute aggregate potential consideration of up to $2,650.0 million.

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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 its $1,743.9 million of cash, cash equivalents and marketable securities as of September 30, 2026 will be sufficient to fund its planned operations and meet its liquidity needs through at least the next 12 months from the issuance of these financial statements.