Form 8-K

8-K — Edgewise Therapeutics, Inc.

Accession: 0001104659-26-056783

Filed: 2026-05-07

Period: 2026-05-07

CIK: 0001710072

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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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):

May 7, 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 May 7, 2026, Edgewise

Therapeutics, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 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 May 7, 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: May 7, 2026

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2613489d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

News Release

Edgewise Therapeutics Reports First Quarter

2026 Financial Results and Advances Clinical Programs in Muscular Dystrophy and Cardiovascular Indications

– Announced positive long-term sevasemten

data demonstrating sustained functional stabilization in Becker muscular dystrophy (Becker) up to 3.5 years of follow-up –

– CIRRUS-HCM 12-week data of EDG-7500

in obstructive and nonobstructive hypertrophic cardiomyopathy (HCM) expected in Q2 2026 –

– Pivotal GRAND CANYON results for sevasemten

in Becker expected in Q4 2026 –

Boulder, Colo., (May 7, 2026) — Edgewise Therapeutics, Inc.

(Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the first quarter of 2026 and

recent business highlights.

“For the first time with an investigational agent, we have generated

long-term data showing that people with Becker remain stable despite a disease that typically leads to significant functional decline,”

said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. “We remain on track to report pivotal top-line data from

GRAND CANYON evaluating sevasemten, which has the potential to support our first marketing application in Becker. We also anticipate results

this quarter from CIRRUS-HCM 12-week Part D evaluating EDG-7500 in HCM, which will help refine our Phase 3 strategy. With multiple

near-term catalysts and a highly focused team, we are well positioned to advance our programs and deliver potentially transformative therapeutic

options for patients facing serious muscle diseases facing high unmet need.”

Recent Highlights

Muscular Dystrophy Program

MESA open-label extension trial in adults with Becker:

MESA is an open-label extension study evaluating sevasemten long-term

safety, tolerability, and efficacy in adults and adolescents with Becker previously treated in sevasemten clinical trials. Nearly all

eligible participants (99%) from prior sevasemten studies (including ARCH, DUNE and CANYON/GRAND CANYON) chose to enroll in the MESA open-label

extension study.

At the 2026

MDA Clinical and Scientific Conference, the Company presented long-term data from MESA showing participants on sevasemten experienced

stabilization of function up to 3.5 years in marked contrast to the functional decline expected from Becker natural history data. The

data reinforce prior clinical findings of sevasemten in Becker, a rare disease with no approved treatments. The results can be found

here. The Company also presented a poster with new analysis from the CANYON study showing sevasemten had a well-tolerated cardiac

profile over 12 months, with no adverse effects on left ventricular ejection fraction (LVEF) or NT-proBNP and evidence of LVEF improvement

in certain subgroups, with positive trends observed across all adult participants versus placebo. The poster can be viewed here.

To learn more about MESA or CANYON, go to clinicaltrials.gov (MESA: NCT06066580, CANYON

(NCT05291091).

GRAND CANYON, a global pivotal placebo-controlled cohort in Becker:

GRAND CANYON is designed to assess the efficacy and safety of sevasemten over an 18-month period, with North Star Ambulatory Assessment

(NSAA) as the primary endpoint. The study is highly powered to be able to show a statistically significant difference in NSAA versus

placebo over 18 months. The Company expects to report top-line data in the fourth quarter of 2026 and is continuing preparations for

a potential marketing application to seek approval as the first targeted therapy for this underserved population, planned for the first

half of 2027. To learn more about GRAND CANYON, go to clinicaltrials.gov (NCT05291091).

LYNX and FOX Phase 2 placebo-controlled trials in boys with Duchenne:

LYNX is designed to evaluate the effect of sevasemten on safety, biomarkers of muscle damage and function in boys with Duchenne in

a placebo-controlled dose ranging study, followed by an open-label extension period. FOX is designed to evaluate the effect of sevasemten

on safety, biomarkers of muscle damage and function in children and adolescents with Duchenne who have been previously treated with gene

therapy. The Company continues to collect longer-term data in the open-label extension portion of these Phase 2 programs to inform the

future clinical studies in Duchenne. For more information, go to clinicaltrials.gov to learn more about LYNX (NCT05540860) and

FOX (NCT06100887).

Cardiovascular Programs

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

Company is advancing CIRRUS-HCM, a multi-part, open-label trial, in participants with HCM at over 20 clinical sites in the U.S. Part A

of the trial evaluated the safety and tolerability of a single oral dose of EDG-7500 in participants with obstructive HCM (oHCM). Parts

B and C evaluated fixed doses of EDG-7500 over 28 days in oHCM and nonobstructive HCM (nHCM), respectively. The results can be found

here. Part D is a 12-week study with an open-label extension including participants with oHCM and nHCM designed to explore

dose response and optimization. The Company plans to report 12-week Part D data (oHCM and nHCM) in the second quarter of 2026 and

initiate Phase 3 in the second half 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, targeted for the treatment of heart failure and other diseases of diastolic dysfunction. EDG-15400 is currently

being evaluated in healthy adults in a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study

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).

First Quarter 2026 Financial Results

Cash, cash equivalents and marketable securities were approximately

$499.6 million as of March 31, 2026.

Research and development (R&D) expenses were $42.7

million for the first quarter of 2026, compared to $36.8 million for the same period in 2025. The increase was primarily driven by increased

clinical development activity related to EDG-7500 and EDG-15400, as well as higher internal personnel-related costs to support the advancement

of the Company’s clinical-stage programs. These increases were partially offset by lower sevasemten clinical program expenses due

to timing of activity in the GRAND CANYON study and patient rollover into the MESA open-label extension study.

General and Administrative (G&A) expenses were $11.5

million for the first quarter of 2026, compared to $9.2 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 $49.0 million or $0.46

per share for the first quarter of 2026, compared to $40.8 million or $0.43 per share for the same period in 2025.

About Edgewise Therapeutics

Edgewise Therapeutics is a leading muscle disease biopharmaceutical

company developing novel therapeutics for muscular dystrophies and serious cardiac conditions. The Company's deep expertise in muscle

physiology is driving a new generation of novel therapeutics. Sevasemten is an orally administered first-in-class fast skeletal myosin

inhibitor in late-stage clinical trials in Becker and Duchenne muscular dystrophies. EDG-7500 is a novel cardiac sarcomere modulator

for the treatment of symptomatic hypertrophic cardiomyopathy, currently in Phase 2 clinical development. EDG-15400 is a novel cardiac

sarcomere modulator for the treatment of heart failure, currently in Phase 1 clinical development. The entire team at Edgewise is dedicated

to our mission: changing the lives of patients and families affected by serious muscle diseases.To learn more, go to edgewisetx.com or

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

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

trials, including timing of reporting data (including 12-week data on the CIRRUS-HCM trial, and the data from the GRAND CANYON trial;

statements regarding Edgewise’s potential marketing application in Becker; statements regarding sevasemten potentially being the

first approved therapy for Becker; statements regarding the potential results of Edgewise’s GRAND CANYON trial; statements regarding

Edgewise’s market opportunity; statements regarding Edgewise’s plans to continue to collect longer-term open-label extension

data for its LYNX and FOX Phase 2 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 its pipeline;

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

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

and EDG-7500; Edgewise’s ability to develop and commercialize sevasemten, 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, topline 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 exposure to additional risk if we develop sevasemten and potential other programs

in connection with other therapies; 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 patient population for our product candidates having a small patient population; 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 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

March 31, 2026

March 31, 2025

Operating expenses:

Research and development

$ 42,651

$ 36,757

General and administrative

11,464

9,202

Total operating expenses

54,115

45,959

Loss from operations

(54,115 )

(45,959 )

Interest income

5,102

5,161

Net loss

$ (49,013 )

$ (40,798 )

Net loss per share - basic and diluted

$ (0.46 )

$ (0.43 )

Weighted-average shares outstanding, basic and diluted

107,116,709

95,130,053

Edgewise Therapeutics, Inc.

Condensed Balance Sheet Data

(in thousands, unaudited)

March 31,

December 31,

2026

2025

Assets

Cash, cash equivalents and marketable securities

$ 499,562

$ 530,109

Other assets

18,960

22,494

Total assets

$ 518,522

$ 552,603

Liabilities and stockholders' equity

Liabilities

25,319

30,346

Stockholders' equity

493,203

522,257

Total liabilities and stockholders' equity

$ 518,522

$ 552,603

###

Edgewise Contacts

Investors:

Behrad Derakhshan, Ph.D., Chief Operating Officer

ir@edgewisetx.com

Media:

Maureen Franco, VP Corporate Communications

media@edgewisetx.com

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