Form 8-K

8-K — Edgewise Therapeutics, Inc.

Accession: 0001104659-26-091671

Filed: 2026-08-06

Period: 2026-08-06

CIK: 0001710072

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event

reported):

August 6, 2026

Edgewise Therapeutics, Inc.

(Exact name of registrant as specified in its

charter)

Delaware

001-40236

82-1725586

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS

Employer

Identification No.)

1715

38th St.

Boulder,

CO 80301

(Address of principal executive offices) (Zip Code)

(720)

262-7002

(Registrant’s telephone number, including

area code)

Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended

to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.

below):

Written communications pursuant to Rule 425 under the

Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the

Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b)

under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c)

under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title

of each class

Trading

Symbol(s)

Name

of each exchange on which registered

Common

Stock, $0.0001 par value per share

EWTX

The

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth

company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange

Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant

has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant

to Section 13(a) of the Exchange Act. ¨

Item 2.02 Results of Operations and Financial Condition.

On August 6, 2026,

Edgewise Therapeutics, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2026.

The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

All of the information

furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18

of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section,

and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except

as shall be expressly set forth by specific reference in such a filing.

Item 9.01

Financial

Statements and Exhibits.

(d)

Exhibits.

Exhibit No.

Description

99.1

Press Release of Edgewise Therapeutics, Inc. dated August 6, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL documents)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934,

the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

EDGEWISE THERAPEUTICS, INC.

By:

/s/ Michael Nofi

Michael Nofi

Chief Financial Officer

Date: August 6, 2026

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2621653d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

News Release

Edgewise Therapeutics Reports Second Quarter

2026 Financial Results

– Announced positive top-line data from

12-week Phase 2 CIRRUS-HCM trial with EDG-7500 in obstructive and nonobstructive hypertrophic cardiomyopathy (HCM) –

– Completed sale of sevasemten and muscular

dystrophy business to Servier for up to $2.65 billion in July 2026, strengthening the balance sheet, sharpening focus on the cardiovascular

pipeline –

BOULDER, Colo., Aug. 6, 2026 — Edgewise Therapeutics, Inc.

(Nasdaq: EWTX), a leading clinical-stage biopharmaceutical company focused on cardiovascular diseases, today reported financial results

for the second quarter of 2026 and recent business highlights.

“In the second quarter, Edgewise entered into a deal to sell

sevasemten and our muscular dystrophy business to Servier. Our post-deal close financial position enhances our ability to advance EDG-7500

and our cardiovascular-focused pipeline toward important clinical and regulatory milestones as an independent company,” said Kevin

Koch, Ph.D., President and Chief Executive Officer of Edgewise Therapeutics. “With positive Phase 2 CIRRUS-HCM results for EDG-7500

and continued progress with EDG-15400, we are well positioned to advance a differentiated pipeline for patients with serious cardiovascular

disease.”

Recent Highlights

Sevasemten and Muscular Dystrophy Program Sale

In July 2026, Edgewise completed the previously announced transaction

under which Servier, an independent international pharmaceutical group governed by a foundation, acquired sevasemten and Edgewise’s

muscular dystrophy business for $1.55 billion in upfront cash consideration and up to $1.1 billion in additional milestone payments, for

aggregate potential consideration of up to $2.65 billion. Servier brings the global development, regulatory, and commercial capabilities

required to fully realize sevasemten's potential for patients. The transaction strengthens Edgewise's balance sheet, enhances financial

flexibility and sharpens the company's strategic focus on advancing its cardiovascular pipeline. This transaction marks Edgewise's transition

to a cardiovascular-focused company, with a pipeline comprising EDG-7500 for hypertrophic cardiomyopathy, EDG-15400 for heart failure

with preserved ejection fraction (HFpEF) and EDG-003 for an undisclosed target.

Cardiovascular Programs

CIRRUS-HCM Phase 2 trial in adults with symptomatic HCM: The

company announced positive top-line results from the 12-week Phase 2 Part D CIRRUS-HCM open label trial of EDG-7500 in obstructive

(oHCM) and nonobstructive (nHCM) HCM, which was designed to inform a Phase 3 trial. Results from the study are available in the company’s

June 2026 press release, which can be found here. The company expects to initiate a Phase 3 trial in the fourth quarter of

2026. To learn more about CIRRUS-HCM, visit ClinicalTrials.gov, NCT06347159.

EDG-15400 and heart failure: EDG-15400 is a novel, oral, selective

cardiac sarcomere modulator being developed for the treatment of heart failure. EDG-15400 has completed dosing in a Phase 1 randomized,

double-blind, placebo-controlled, single and multiple ascending dose study in healthy adults evaluating safety, tolerability, pharmacokinetics

and pharmacodynamics. The company expects to initiate a Phase 2 trial in participants with heart failure with preserved ejection fraction

(HFpEF) in the second half of 2026. To learn more about this study, go to ClinicalTrials.gov (NCT07177066).

Second Quarter 2026 Financial Results

Cash, cash equivalents and marketable securities were approximately

$460.7 million as of June 30, 2026. Our cash and cash equivalents at June 30, 2026 do not include the $1,550.0 million in upfront

cash proceeds for the sale of sevasemten on July 10, 2026. Combining the actual balance at June 30, 2026 with the upfront cash

proceeds of the sale provides for a pro forma balance of $2,010.7 million before taxes and transaction related costs.

Research and development (R&D) expenses were $47.5

million for the second quarter of 2026, compared to $33.6 million for the same period in 2025. The increase was primarily driven by increased

clinical development activity related to EDG-7500, EDG-15400 and patient rollover activity in the MESA open-label extension study, as

well as higher personnel-related costs to support the advancement of the Company's clinical-stage programs.

General and Administrative (G&A) expenses were $14.4

million for the second quarter of 2026, compared to $9.1 million for the same period in 2025. The increase was primarily due to higher

personnel-related costs, including stock-based compensation, as the Company expanded its organizational capabilities to support clinical

development, as well as increased professional fees and other administrative costs.

Net loss and net loss per share were $57.3 million or $0.53

per share for the second quarter of 2026, compared to $36.1 million or $0.34 per share for the same period in 2025.

About Edgewise Therapeutics

Edgewise Therapeutics is a leading biopharmaceutical company focused

on novel, muscle-targeted therapeutics. Leveraging its expertise in muscle biology and small molecule drug development, Edgewise is advancing

a cardiovascular pipeline targeting significant unmet needs, including hypertrophic cardiomyopathy, heart failure and other serious cardiovascular

and cardiometabolic conditions. To learn more, go to edgewisetx.com or follow Edgewise on LinkedIn, X, Facebook and Instagram.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as that term

is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in

this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other

things, statements regarding the potential of, and expectations regarding, Edgewise’s product candidates and programs, including

EDG-7500, EDG-15400 and its cardiovascular programs; statements regarding Edgewise’s expectations relating to its clinical trials;

statements regarding timing of Edgewise’s initiation of a Phase 3 trial of EDG-7500 in HCM and a Phase 2 trial of EDG-15400 in participants

with HFpEF; statements regarding Edgewise’s ability to advance a differentiated pipeline for patients with serious cardiovascular

disease; statements regarding the sale of sevasemten and muscular dystrophy business to Servier (Transaction), including potential payments

which may become owing to Edgewise; and statements by Edgewise’s President and Chief Executive Officer. Words such as “believes,”

“anticipates,” “plans,” “expects,” “intends,” “will,” “goal,”

“potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained

herein are based upon Edgewise’s current expectations and involve assumptions that may never materialize or may prove to be incorrect.

Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties,

including but not limited to: risks associated with Edgewise’s limited operating history, its products being early in development

and not having products approved for commercial sale; risks associated with Edgewise not having generated any revenue to date; Edgewise’s

ability to achieve objectives relating to the discovery, development and commercialization of its product candidates, if approved; Edgewise’s

potential need for substantial additional capital to finance its operations; Edgewise’s substantial dependence on the success of

EDG-7500; Edgewise’s ability to develop and commercialize EDG-7500 and EDG-15400, and discover, develop and commercialize product

candidates in its cardiovascular, cardiometabolic and future programs; risks related to Edgewise’s clinical trials of its product

candidates not demonstrating safety and efficacy; risks related to Edgewise’s product candidates causing serious adverse events,

toxicities or other undesirable side effects; the outcome of preclinical testing and early clinical trials not being predictive of the

success of later clinical trials and the risks related to the results of Edgewise’s clinical trials not satisfying the requirements

of regulatory authorities; delays or difficulties in the enrollment and/or maintenance of patients in clinical trials; risks related to

failure to capitalize on other indications or product candidates; risks related to competition; risks relating to interim, top-line and

preliminary data from Edgewise’s clinical trials changing as more patient data becomes available; risks related to failure to develop

a proprietary drug discovery platform; risks related to production of drugs by Edgewise’s third-party manufacturers; risks related

to changes in methods of product candidate manufacturing or formulation; risks related to not achieving adequate market acceptance; risks

related to the regulatory approval processes of domestic and foreign authorities being lengthy, time consuming and inherently unpredictable;

risks relating to disruptions at the FDA, the SEC and other government agencies; risks relating to Edgewise’s ability to attract

and retain highly skilled executive officers and employees; Edgewise’s ability to obtain and maintain intellectual property protection

for its product candidates; Edgewise’s reliance on third parties; risks related to future acquisitions or strategic partnerships;

risks related to Edgewise’s future operations following the sale of sevasemten; risks relating to Edgewise not receiving milestone

payments related to the Transaction; risks related to general economic and market conditions; and other risks. Information regarding the

foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Edgewise files from time

to time with the U.S. Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release,

and Edgewise assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ

from those projected in the forward-looking statements, except as required by law.

This press release contains hyperlinks to information that is not deemed

to be incorporated by reference into this press release.

Edgewise Therapeutics, Inc.

Condensed Statement of Operations

(in thousands except share and per share amounts, unaudited)

Three months ended

June 30, 2026

June 30, 2025

Operating expenses:

Research and development

$ 47,548

$ 33,558

General and administrative

14,395

9,052

Total operating expenses

61,943

42,610

Loss from operations

(61,943 )

(42,610 )

Interest income

4,616

6,495

Net loss

$ (57,327 )

$ (36,115 )

Net loss per share - basic and diluted

$ (0.53 )

$ (0.34 )

Weighted-average shares outstanding, basic and diluted

107,669,774

104,940,493

Edgewise Therapeutics,

Inc.

Condensed Balance Sheet

Data

(in thousands, unaudited)

June 30,

December 31,

2026

2025

Assets

Cash, cash equivalents and marketable securities

$ 460,709

$ 530,109

Other assets

18,979

22,494

Total assets

$ 479,688

$ 552,603

Liabilities and stockholders' equity

Liabilities

31,611

30,346

Stockholders' equity

448,077

522,257

Total liabilities and stockholders' equity

$ 479,688

$ 552,603

###

Edgewise Contacts

Investors:

Behrad Derakhshan, Ph.D., Chief Operating Officer

ir@edgewisetx.com

Media:

Maureen Franco, Vice President, Corporate Communications

media@edgewisetx.com

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