Full Press Release Details
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."
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
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
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
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
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