Form 8-K - Current report

 

 

 

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):
December 16, 2024

 

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)

 

[phone] 

(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 x

 

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 7.01 Regulation FD Disclosure.

 

On December 16, 2024, Edgewise Therapeutics, Inc. (the “Company”) issued a press release announcing positive topline results from the Phase 2 CANYON trial of sevasemten in individuals with Becker muscular dystrophy. The press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

On December 16, 2024, the Company also posted a presentation to its Investor Relations website (https://investors.edgewisetx.com). A copy of the presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information in this Item 7.01, including Exhibits 99.1 and 99.2 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.

 

Item 8.01 Other Events.

 

On December 16, 2024, the Company announced positive topline results from the Phase 2 CANYON trial of sevasemten in individuals with Becker muscular dystrophy.

 

Overview of CANYON and Clinical Results

 

CANYON, the largest interventional Becker muscular dystrophy trial, is a Phase 2, double-blind, randomized, placebo-controlled study to investigate the effect of sevasemten on the safety, pharmacokinetics, biomarkers, and functional measures of participants (NCT05291091). The trial was not powered for the functional endpoints. Forty adults and 29 adolescents with Becker muscular dystrophy were enrolled. This study had a 4-week screening period, a 12-month treatment period, followed by a 4-week follow-up period. The adult participants were randomized to sevasemten or placebo in a 3:1 ratio. The adolescent participants were randomized in a 2:1 ratio to sevasemten or placebo and were assessed for safety and tolerability. The data analysis included the complete adult safety population of 40 individuals. There was a notable imbalance between adult participants in the sevasemten and placebo groups with the sevasemten group having more advanced disease at baseline based on all functional measures and MRI.

 

Primary Endpoint: The primary endpoint to assess the efficacy of sevasemten compared to placebo was change from baseline in creatine kinase (“CK”) over the treatment period for adults. The results demonstrated a significant change from baseline in CK in the sevasemten-treated group (difference vs. placebo, 28% average decrease over months 6 through 12; p=0.02).

 

Key Secondary Endpoint: The key secondary endpoint was the change from baseline in NSAA total score in adults at month 12. North Star Ambulatory Assessment (“NSAA”) is a scale commonly used to rate motor function. The between-group difference was 1.1 points, favoring sevasemten; p=0.16 across all adult participants. NSAA remained stable over time in the sevasemten treatment group, similar to the observations in the ARCH study. Further, while the placebo group was small in number (n=12), NSAA declined similarly to that observed in previous natural history studies.^1,2,3

 

Other Secondary Endpoints: Plasma fast skeletal muscle troponin I (“TNNI2”) decreased 77% from baseline in the sevasemten-treated group compared to placebo, averaged over months 6 through 12 in adults; p<0.001.

 

The 10-meter walk/run, 4-stair climb and 100-meter timed test showed trends towards improvement, compared to placebo. The Company continues to evaluate additional secondary and exploratory endpoints.

 

Safety and Tolerability: Sevasemten was well-tolerated, and no new safety concerns were identified.

 

 

 

 

CANYON Implications to GRAND CANYON: The functional observations from the CANYON study support that the GRAND CANYON pivotal cohort’s primary endpoint is powered at >95% to demonstrate a statistically significant NSAA difference at 18 months.

 

References

 

[1] Bello L, et al. Functional changes in Becker muscular dystrophy: implications for clinical trials in dystrophinopathies. Sci Rep. 2016;6:32439. doi:10.1038/srep32439.

 

[2] van de Velde NM, et al. Selection approach to identify the optimal biomarker using quantitative muscle MRI and functional assessments in Becker muscular dystrophy. Neurology. 2021;97(5):e513-e522. doi: 10.1212/WNL.0000000000012233.

 

[3] De Wel B, et al. Lessons for future clinical trials in adults with Becker muscular dystrophy: disease progression detected by muscle magnetic resonance imaging, clinical and patient-reported outcome measures. Eur J Neurol. 2024:e16282. doi:10.1111/ene.16282. Online ahead of print.

 

Cautionary Note Regarding Forward-Looking Statements

 

This Form 8-K 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 Form 8-K that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding Edgewise’s cash runway; the potential of, and expectations regarding Edgewise’s expectations relating to its clinical trials and clinical development of sevasemten (EDG-5506), including statements regarding the number of individuals to be recruited, timing of completion of recruitment and over-enrollment of the GRAND CANYON trial; statements regarding the potential of, and expectations regarding, Edgewise’s product candidates and programs, including sevasemten and EDG-7500; statements regarding Edgewise’s milestones; statements regarding whether data from the GRAND CANYON trial could support a marketing application; statements regarding the Company’s plans to engage the FDA and European Medicines Agency; statements about sevasemten being the potential first treatment for Becker; statements about the submission of results of the CANYON trial for publication at a future medical congress; and statements by Edgewise’s chief executive officer and chief medical officer and Craig M. McDonald, M.D. 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 the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company, including the potential for Edgewise’s product candidates to cause serious adverse events; Edgewise’s ability to develop, initiate or complete clinical trials for, obtain approvals for and commercialize any of its product candidates; Edgewise’s ability to take advantage of potential benefits associated with designations granted by FDA and/or to maintain qualifications for applicable designations over time; the timing, progress and results of clinical trials for sevasemten and EDG-7500; Edgewise’s ability to enroll and maintain patients in clinical trials; Edgewise’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; the timing, scope and likelihood of regulatory filings and approvals; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results, including that the primary endpoint of the GRAND CANYON trial (change from baseline in NSAA) will be met even though it was not met as a secondary endpoint in the CANYON trial; the potential that the outcome of preclinical testing and early clinical trials, including the results from the CANYON trial, may not be predictive of the success of later clinical trials, including that the trends from the CANYON trial will also be seen, and will be statistically significant, in the GRAND CANYON trial; Edgewise may gain further insights from its analysis of the CANYON trial results over time, including Edgewise’s ongoing evaluation of additional secondary and exploratory endpoints; Edgewise’s ability to develop a proprietary drug discovery platform to build a pipeline of product candidates; Edgewise’s manufacturing, commercialization and marketing capabilities and strategy; the size of the market opportunity for Edgewise’s product candidates; the loss of key scientific or management personnel; competition in the industry in which Edgewise operates; Edgewise’s reliance on third parties; Edgewise’s ability to obtain and maintain intellectual property protection for its product candidates; 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 Form 8-K, 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.

 

 

 

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.		Description
99.1		Press Release, dated December 16, 2024.
99.2		Presentation, dated December 16, 2024.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

 

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/ Behrad Derakhshan, Ph.D.
	Behrad Derakhshan, Ph.D.
	Chief Business Officer

 

Date: December 16, 2024

 

 

 

 

Exhibit 99.1

 

 

News Release

 

Edgewise Therapeutics Announces Positive Topline Results from the CANYON Phase 2 Trial of Sevasemten in Individuals with Becker Muscular Dystrophy (Becker)

 

– Trial met primary endpoint of reduction in circulating levels of creatine kinase (CK), a biomarker associated with skeletal muscle damage, in the largest Becker interventional trial to date –

 

– On the key secondary endpoint, sevasemten-treated patients showed stabilization of North Star Ambulatory Assessment (NSAA) with a trend towards improvement at 12 months compared to placebo –

 

– Sevasemten was well-tolerated and no new safety concerns were observed –

 

– Edgewise leadership to discuss CANYON findings on Monday, December 16 at 8:30 a.m. Eastern Time at a virtual investor event –

 

Boulder, Colo., (December 16, 2024) – Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced positive topline results from the Phase 2 CANYON trial of sevasemten in individuals with Becker muscular dystrophy. Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor designed to protect muscle against contraction-induced damage in muscular dystrophies. The trial met its primary endpoint of change from baseline in CK. CANYON is the largest interventional trial to date in Becker and the first to achieve its primary endpoint.

 

NSAA, the key secondary endpoint of function, showed a trend towards improvement over time in the sevasemten-treated group. Plasma fast skeletal muscle troponin I (TNNI2), a target-specific biomarker of fast skeletal muscle damage, showed a significant reduction, compared to placebo. Additional functional measures, including the 10-meter walk/run, 4-stair climb and 100-meter timed test, showed trends towards improvement compared to placebo. Notably, the treatment population had more advanced disease than placebo.

 

Sevasemten was well-tolerated, and no new safety concerns were observed in either the adult or adolescent patient populations. Ninety-nine percent of eligible participants from CANYON and other sevasemten trials in Becker have enrolled in MESA, the ongoing open label extension trial.

 

“Becker muscular dystrophy is a devastating neuromuscular disease characterized by rapid progression once functional decline begins. This landmark study presents compelling biomarker data and promising signals that suggest the potential for functional stabilization with administration of sevasemten,” said Craig M. McDonald, M.D., Distinguished Professor and Chair at the UC Davis Health Department of Physical Medicine and Rehabilitation, and a Principal Investigator in CANYON and GRAND CANYON. “Becker has no approved therapies. I look forward to the results of the GRAND CANYON pivotal cohort with the hope of bringing the first treatment option to this patient population.”

 

 

 

 

“We are very encouraged by the CANYON results in Becker and the potential of this novel muscle-targeted therapeutic,” said Joanne Donovan, Ph.D., M.D., Chief Medical Officer, Edgewise. “This confirmed our previous observations in the ARCH study of significant decreases in biomarkers of muscle damage and similarly we are seeing evidence of preservation of function in Becker patients.”

 

The Company is on track to complete recruitment in the GRAND CANYON cohort by the first quarter of 2025. Based on these positive Phase 2 results, the Company plans to engage the U.S. Food and Drug Administration (FDA) and European Medicines Agency about marketing authorization filing strategies for sevasemten in Becker.

 

The Company intends to submit the complete results of the CANYON study for publication at a future medical congress.

 

Overview of CANYON and Clinical Results

 

CANYON, the largest interventional Becker trial, is a Phase 2, double-blind, randomized, placebo-controlled study to investigate the effect of sevasemten on the safety, pharmacokinetics, biomarkers, and functional measures of participants (NCT05291091). The trial was not powered for the functional endpoints. Forty adults and 29 adolescents with Becker muscular dystrophy were enrolled. This study had a 4-week screening period, a 12-month treatment period, followed by a 4-week follow-up period. The adult participants were randomized to sevasemten or placebo in a 3:1 ratio. The adolescent participants were randomized in a 2:1 ratio to sevasemten or placebo and were assessed for safety and tolerability. The data analysis included the complete adult safety population of 40 individuals. There was a notable imbalance between adult participants in the sevasemten and placebo groups with the sevasemten group having more advanced disease at baseline based on all functional measures and MRI.

 

Primary Endpoint: The primary endpoint to assess the efficacy of sevasemten compared to placebo was change from baseline in CK over the treatment period for adults. The results demonstrated a significant change from baseline in CK in the sevasemten-treated group (difference vs. placebo, 28% average decrease over months 6 through 12; p=0.02).

 

Key Secondary Endpoint: The key secondary endpoint was the change from baseline in NSAA total score in adults at month 12. NSAA is a scale commonly used to rate motor function. The between-group difference was 1.1 points, favoring sevasemten; p=0.16 across all adult participants. NSAA remained stable over time in the sevasemten treatment group, similar to the observations in the ARCH study. Further, while the placebo group was small in number (n=12), NSAA declined similarly to that observed in previous natural history studies.^1,2,3

 

Other Secondary Endpoints: Plasma TNNI2 decreased 77% from baseline in the sevasemten-treated group compared to placebo, averaged over months 6 through 12 in adults; p<0.001.

 

The 10-meter walk/run, 4-stair climb and 100-meter timed test showed trends towards improvement, compared to placebo. The Company continues to evaluate additional secondary and exploratory endpoints.

 

Safety and Tolerability: Sevasemten was well-tolerated, and no new safety concerns were identified.

 

CANYON Implications to GRAND CANYON: The functional observations from the CANYON study support that the GRAND CANYON pivotal cohort’s primary endpoint is powered at >95% to demonstrate a statistically significant NSAA difference at 18 months.

 

 

 

 

MESA, open label extension trial in adults with Becker: The Company is advancing MESA, an open-label extension trial to assess the long-term effect of sevasemten in individuals with Becker. MESA provides continued access to sevasemten to participants who were previously enrolled in ARCH, or completed CANYON, GRAND CANYON, or DUNE. To date, 99% of eligible participants completing these trials have enrolled in MESA.

 

GRAND CANYON, a global pivotal cohort in Becker: GRAND CANYON, an expansion of the CANYON placebo-controlled trial, is a multi-center, randomized, double-blind, placebo-controlled cohort to evaluate the safety and efficacy of sevasemten in adults with Becker. The primary endpoint of GRAND CANYON is change from baseline in NSAA at 18 months. In addition, other functional assessments, biomarkers of muscle damage, MRI, patient-reported outcomes and safety will be assessed. GRAND CANYON is an 18-month cohort anticipated to recruit approximately 120 individuals with Becker. Data from GRAND CANYON, if positive, could support a marketing application. To learn more, go to clinicaltrials.gov (NCT05291091).

 

Sevasemten has achieved notable regulatory milestones by securing FDA Orphan Drug Designation for the treatment of Becker and Duchenne, Rare Pediatric Disease Designation (RPDD) for the treatment of Duchenne, and Fast Track designations for the treatment of Becker and Duchenne. Further, sevasemten secured the EMA Orphan Drug Designations for the treatment of Becker and Duchenne.

 

Upcoming CANYON Data Presentations:

 

Virtual Investor Event

 

Members of the Edgewise management team will hold a live webcast on Monday, December 16, at 8:30 a.m. ET to discuss the CANYON data, and will be joined by Dr. McDonald, who will share his perspective of sevasemten and Becker. An accompanying slide presentation will also be available. To register for the live webcast and replay, please visit the Edgewise events page.

 

Patient Community Webinar

 

Members of Edgewise management will hold a community webinar on Wednesday, December 18, 2024, at 1 p.m. ET to discuss these data and the GRAND CANYON pivotal study. To register for the community webinar, please click here.

 

About Becker Muscular Dystrophy

 

Becker is a rare, genetic, life-shortening, debilitating and degenerative neuromuscular disorder. The disease predominantly affects males and imposes significant physical, emotional, financial, and social impacts on the individual and their caregivers. Individuals with Becker experience contraction-induced muscle damage, which is the primary driver of muscle loss and impaired motor function in muscular dystrophies. Functional decline can begin at any age, and once that muscle loss occurs, the decline in function is irreversible and continues throughout the individual’s life. Some individuals living with Becker experience heart failure from cardiomyopathy, which may result in heart transplantation or early death. Currently, there is no cure for Becker; early and long-term multidisciplinary care is critical for optimized disease management. There is a great need for more Becker-specific scientific research, clinical programs, and treatment guidelines to improve management of this disease. To learn more about Becker, go to https://beckermusculardystrophy.com/

 

 

 

 

About Sevasemten (EDG-5506) for Becker and Duchenne Muscular Dystrophies

 

Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor designed to protect muscle against contraction-induced muscle damage in muscular dystrophies including Becker and Duchenne.

 

Sevasemten presents a novel mechanism of action designed to selectively limit the exaggerated muscle damage caused by the absence or loss of functional dystrophin. By minimizing the progressive muscle damage that leads to functional impairment, sevasemten has the potential to benefit a broad range of patients suffering from debilitating neuromuscular disorders. Its unique mechanism of action provides the potential to establish sevasemten as a foundational therapy in dystrophinopathies, either as a single agent therapy or in combination with available therapies and those in development.

 

Sevasemten is being studied in the Phase 2 CANYON study with a pivotal cohort GRAND CANYON in adults and adolescents with Becker muscular dystrophy. Sevasemten is also being studied in the ongoing Phase 2 trials, LYNX and FOX, in children and adolescents with Duchenne muscular dystrophy.

 

For more information on Edgewise’s clinical trials https://edgewisetx.com/clinical-trials.

 

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 hypertrophic cardiomyopathy and other diseases of diastolic dysfunction, currently in Phase 2 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: www.edgewisetx.com or follow us on LinkedIn , X, Facebook and Instagram.

 

References

 

[1] Bello L, et al. Functional changes in Becker muscular dystrophy: implications for clinical trials in dystrophinopathies. Sci Rep. 2016;6:32439. doi:10.1038/srep32439.

 

[2] van de Velde NM, et al. Selection approach to identify the optimal biomarker using quantitative muscle MRI and functional assessments in Becker muscular dystrophy. Neurology. 2021;97(5):e513-e522. doi: 10.1212/WNL.0000000000012233.

 

[3] De Wel B, et al. Lessons for future clinical trials in adults with Becker muscular dystrophy: disease progression detected by muscle magnetic resonance imaging, clinical and patient-reported outcome measures. Eur J Neurol. 2024:e16282. doi:10.1111/ene.16282. Online ahead of print.

 

 

 

 

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 expectations relating to its clinical trials and clinical development of sevasemten, including statements regarding the number of individuals to be recruited, timing of completion of recruitment and over-enrollment of the GRAND CANYON trial; statements regarding the potential of, and expectations regarding, Edgewise’s product candidates and programs, including sevasemten (EDG-5506) and EDG-7500; statements regarding Edgewise’s milestones; statements regarding whether data from the GRAND CANYON trial could support a marketing application; statements regarding the Company’s plans to engage the FDA and European Medicines Agency; statements about the submission of results of the CANYON trial for publication at a future medical congress; and statements by Edgewise’s chief medical officer and Craig M. McDonald, M.D. 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 the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company, including the potential for Edgewise’s product candidates to cause serious adverse events; Edgewise’s ability to develop, initiate or complete clinical trials for, obtain approvals for and commercialize any of its product candidates; Edgewise’s ability to take advantage of potential benefits associated with designations granted by FDA and/or to maintain qualifications for applicable designations over time; the timing, progress and results of clinical trials for sevasemten and EDG-7500; Edgewise’s ability to enroll and maintain patients in clinical trials; Edgewise’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; the timing, scope and likelihood of regulatory filings and approvals; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results, including that the primary endpoint of the GRAND CANYON trial (change from baseline in NSAA) will be met even though it was not met as a secondary endpoint in the CANYON trial; the potential that the outcome of preclinical testing and early clinical trials, including the results from the CANYON trial, may not be predictive of the success of later clinical trials, including that the trends from the CANYON trial will also be seen, and will be statistically significant, in the GRAND CANYON trial; Edgewise may gain further insights from its analysis of the CANYON trial results over time, including Edgewise’s ongoing evaluation of additional secondary and exploratory endpoints; Edgewise’s ability to develop a proprietary drug discovery platform to build a pipeline of product candidates; Edgewise’s manufacturing, commercialization and marketing capabilities and strategy; the size of the market opportunity for Edgewise’s product candidates; the loss of key scientific or management personnel; competition in the industry in which Edgewise operates; Edgewise’s reliance on third parties; Edgewise’s ability to obtain and maintain intellectual property protection for its product candidates; 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.

 

###

 

Edgewise Contacts
Investors:
Behrad Derakhshan, Ph.D., Chief Business Officer
[e-mail]

 

Media:
Maureen Franco, VP Corporate Communications
[e-mail]

 

 

 

Exhibit 99.2

1 ©2024 Edgewise Therapeutics. All rights reserved. Sevasemten: Topline Results from the CANYON Phase 2 Trial in Becker December 16, 2024

2 This presentation 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 presentation 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 cash runway, Edgewise’s expectations relating to its clinical trials and clinical development of sevasemten (EDG-5506) and EDG-7500, including statements regarding the number of individuals to be recruited, timing of completion of recruitment and over-enrollment of the GRAND CANYON trial; statements regarding the potential of, and expectations regarding, Edgewise’s product candidates and programs, including sevasemten and EDG-7500; statements regarding Edgewise’s milestones; statements regarding whether data from the GRAND CANYON trial could support a marketing application; statements regarding the Company’s plans to engage the FDA and European Medicines Agency; statements about sevasemten being the potential first treatment for Becker; and statements by Edgewise’s chief executive officer and chief medical officer and Craig M. McDonald, M.D. 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 the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company, including the potential for Edgewise’s product candidates to cause serious adverse events; Edgewise’s ability to develop, initiate or complete clinical trials for, obtain approvals for and commercialize any of its product candidates; Edgewise’s ability to take advantage of potential benefits associated with designations granted by FDA and/or to maintain qualifications for applicable designations over time; the timing, progress and results of clinical trials for sevasemten and EDG-7500; Edgewise’s ability to enroll and maintain patients in clinical trials; Edgewise’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; the timing, scope and likelihood of regulatory filings and approvals; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results, including that the primary endpoint of the GRAND CANYON trial (change from baseline in NSAA) will be met even though it was not met as a secondary endpoint in the CANYON trial; the potential that the outcome of preclinical testing and early clinical trials, including the results from the CANYON trial, may not be predictive of the success of later clinical trials, including that the trends from the CANYON trial will also be seen, and will be statistically significant, in the GRAND CANYON trial; Edgewise may gain further insights from its analysis of the CANYON trial results over time, including Edgewise’s ongoing evaluation of additional secondary and exploratory endpoints; Edgewise’s ability to develop a proprietary drug discovery platform to build a pipeline of product candidates; Edgewise’s manufacturing, commercialization and marketing capabilities and strategy; the size of the market opportunity for Edgewise’s product candidates; the loss of key scientific or management personnel; competition in the industry in which Edgewise operates; Edgewise’s reliance on third parties; Edgewise’s ability to obtain and maintain intellectual property protection for its product candidates; 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 presentation, 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. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products. Forward Looking Statement

Agenda 1. Introduction 2. Becker muscular dystrophy and sevasemten 3. Topline results: Phase 2 CANYON trial in Becker 4. Sevasemten future development plans 5. Clinical perspectives on the results 6. Closing remarks 7. Q & A Distinguished Professor and Chair at the UC Davis Health Department of Physical Medicine and Rehabilitation Dr. Kevin Koch Dr. Craig M. McDonald Chief Executive Officer Dr. Joanne Donovan Chief Medical Officer

Focused on muscle science ● Global leader in muscle disease therapeutic development ● Deep knowledge of integrated muscle physiology ● Novel & holistic therapeutic approach to protect muscle Rapidly advancing portfolio ● Sevasemten pivotal program in muscular dystrophies including potential first treatment for Becker ● Advancing EDG-7500 in oHCM, nHCM, and other potential indications ● Novel cardiometabolic targets in discovery Unwavering patient commitment ● Mission-driven focus on unmet needs in severe muscle conditions ● Patients & families are critical voices in all development programs Abbreviations: oHCM, obstructive hypertrophic cardiomyopathy, nHCM, non-obstructive hypertrophic cardiomyopathy

5 The Evolution of Edgewise 2017 2020 2022 2023 2025 Founded as a muscle platform company targeting genetically driven muscle diseases EWTX completes IPO, expands development programs First program targeting muscular dystrophies Sevasemten, a fast skeletal myosin inhibitor, enters P1 in HVs and Becker MUSCULAR DYSTROPHY PROGRAM MILESTONES Sevasemten enters P2 in Duchenne Initiated GRAND CANYON pivotal cohort sevasemten in Becker 2021 2024 EDG-7500 identified as lead molecule with unique characteristics EDG-7500 characterized as a selective cardiac sarcomere modulator EDG-7500 enters the clinic; continued research on novel cardiometabolic targets Initiated CIRRUS-HCM, EDG-7500 P2 program in oHCM and nHCM CARDIOVASCULAR PROGRAM MILESTONES Identified a differentiated set of CV molecules as part of skeletal muscle counter-screen CV program initiated Sevasemten ARCH open label 24-month results in Becker Sevasemten, P2 CANYON 12-month results in Becker 2019 Initiated Becker ARCH open label study with sevasemten Abbreviations: HVs, healthy volunteers, CV, cardiovascular, oHCM, obstructive hypertrophic cardiomyopathy, nHCM, non-obstructive hypertrophic cardiomyopathy

6 ARCH, CANYON and the Evolution to GRAND CANYON Expedited the Development Timeline for Sevasemten in Becker​ • The Phase 2 CANYON study was originally designed as a dose-finding study to evaluate the effect of sevasemten on safety, pharmacokinetics, biomarkers, and function in individuals with Becker • 12-month data from the ARCH study supported the hypothesis that a reduction in contraction-induced muscle damage has the potential to preserve and improve muscle function while preventing disease progression • ARCH identified key factors, including the dose of sevasemten, to allow expansion of CANYON to include the GRAND CANYON cohort as a potentially registrational cohort with NSAA as the primary endpoint • GRAND CANYON is the first pivotal cohort of an investigational therapy for Becker. Data from GRAND CANYON, if positive, could support a marketing application 10 mg PO daily 15 mg PO daily Placebo 20 mg PO daily PIVOTAL Cohort 10 mg PO daily (18 mos.) Placebo 10 mg PO daily (12 mos.) Placebo N=40 Original CANYON Design Expanded CANYON/GRAND CANYON Design N=120 This strategic pivot significantly reduced development timelines to support a potential approval of sevasemten for individuals living with Becker

Becker Muscular Dystrophy and Sevasemten Dr. Joanne Donovan

8 I was told, ‘You’re lucky you don’t have Duchenne.’ It’s frustrating that you live longer, but you are constantly going downhill” – Individual living with Becker Our goal is to positively impact the course of Becker muscular dystrophy ● Becker is a rare, genetic, life-shortening, debilitating and degenerative neuromuscular disorder ● The disease predominately affects males and imposes significant physical, emotional, financial and social impacts on the individuals and their caregivers ● Individuals with Becker lose mobility, function and independence in the prime of their lives ● There is currently no treatment for Becker

9 Sevasemten is an investigational therapy that has not been approved for use in muscular dystrophies by any regulatory agency, as its safety and effectiveness have not been established for the treatment of these diseases. Abbreviations: CK, creatine kinase Sevasemten: A First-in-Class Fast Myofiber (Type II) Myosin Inhibitor Designed to Protect Against Contraction-Induced Muscle Injury Collapsed sarcomere Protected sarcomere Progressive disease pathology Contraction-induced muscle injury Sevasemten Prevention of contraction-induced muscle injury Excessive contraction induced muscle damage Duchenne Becker Sevasemten Therapeutic Hypothesis

Abbreviations: CK, Creatine Kinase; TNNI2, Fast Skeletal Muscle Troponin I 10 Elevated Circulating Levels of Muscle Injury Biomarkers, including CK and TNNI2, Indicate Ongoing Muscle Damage in Muscular Dystrophies Contraction-Induced Muscle Injury in Muscular Dystrophies Contraction induced muscle damage causes excessive degeneration Fast fibers are subsequently injured leading to release of muscle injury biomarkers into the circulation CK CK CK TNNI2 TNNI2 TNNI2 Circulating Levels of Muscle Injury Biomarkers Can be Measured to Determine Ongoing Muscle Damage in Muscular Dystrophies

11 PK, biomarkers and longer-term safety OLE Complete Function (NSAA), PK, biomarkers and longer-term safety OLE Recruiting GRASP Recruiting -01-002 24-Month, observational study Abbreviations: LGMD, limb-girdle muscular dystrophy; NSAA, North Star ambulatory assessment; PK, pharmacokinetics Our Commitment to Becker: Completed and Ongoing Clinical Trials Phase 2 Becker Pivotal Cohort Becker (NCT05291091) Becker Natural History Study (NCT05257473) Exercise challenge study OLE Complete Phase 2 Becker, LGMD2i, & McArdle Phase 1 Becker Open-label, safety, PK, function OLE Complete Open-label long-term safety, biomarkers and functional measures Enrolling by invitation Becker Open Label Extension Study (NCT06066580)

Topline Results

13 A Phase 2 Multi-Center Study to Assess Sevasemten Safety and Effect on Biomarkers in Adults with Becker * Adolescents were not selected based on NSAA Reference: NCT05160415 Abbreviations: CK, creatine kinase 5 mg or 12.5 mg PO daily Study design - 12 months Key Secondary: North Star Ambulatory Assessment (NSAA); change from baseline at month 12 Additional Endpoints: Safety, PK, biomarkers, timed function tests, MRI Month Placebo 10 mg PO daily Placebo 0 1 3 6 9 12 ADULTS ADOLESCENTS (ages 12-17) ADULT PRIMARY EFFICACY ENDPOINT Change from baseline in CK averaged across Months 6, 9 and 12 KEY INCLUSION CRITERIA Ambulatory males aged 12 to 50 years with a dystrophin mutation and a Becker phenotype, not on corticosteroids, with a NSAA between 5-32* PATIENTS ENROLLED Adults: 40 Adolescents: 29

14 Summary of Key Study Metrics * Trial sites in the US, UK and the Netherlands 16 sites 3 countries Enrollment: Largest Becker study to date Total of 80 patients screened and 69 patients enrolled: • Adults: 40 • Adolescents: 29 Low discontinuation rate • 4% overall • 2.5% in adult cohort (1 out of 40 enrolled) 99% of eligible participants enrolled in MESA open-label extension • Approximately, 85 Becker patients currently enrolled in MESA *

15 Becker Mutation Overview: Slow Progressor Genotypes were Largely Excluded with Functional Cut-Off Criteria Mutation type Adults (N=40) Adolescents (N=29) Becker mutations associated with progression 39 26 45-x 20 11 Other 19 15 None/very slow progression Becker mutations 1 3 X-51 1 (sevasemten) 2 (sevasemten) Del 48 0 0 45-55 (associates with late myopathy) 0 1 (sevasemten) Reference: Bello L., et. al., Sci Rep., 2016

16 Overview of Baseline Function in Safety Population *At baseline, 1 placebo and 9 sevasemten treated participants were unable to rise from floor Functional test Adults Sevasemten (n=28) Adults Placebo (n=12) ARCH (N=12) Mean total NSAA score, points (SD) 18.4 (7.66) 24.2 (8.19) 15.1 (8.4) Mean 4SC velocity, 1/seconds (SD) 0.22 (0.128) 0.34 (0.173) 0.19 (0.164) Mean RFF velocity, 1/seconds (SD)* 0.14 (0.114) 0.21 (0.128) 0.16 (0.196) Mean 10MWR velocity, meters/second (SD) 1.52 (0.731) 2.00 (0.884) 1.15 (0.521) Mean 100MTT velocity, meters/second (SD) 1.50 (0.856) 1.78 (0.782) 1.08 (0.496) Abbreviations: NSAA, North Star Ambulatory Assessment

17 Functional Measures Not Well Matched at Baseline; Patients in Sevasemten Group had Lower Baseline NSAA *At baseline, 1 placebo and 9 sevasemten treated participants were unable to rise from floor Functional test Adults Sevasemten (n=28) Adults Placebo (n=12) Difference (from placebo) P-value vs. Placebo Mean total NSAA score, points (SD) 18.4 (7.66) 24.2 (8.19) -5.8 0.04 Mean 4SC velocity, 1/seconds (SD) 0.22 (0.128) 0.34 (0.173) -0.12 0.02 Mean RFF velocity, 1/seconds (SD)* 0.14 (0.114) 0.21 (0.128) -0.07 0.09 Mean 10MWR velocity, meters/second (SD) 1.52 (0.731) 2.00 (0.884) -0.48 0.08 Mean 100MTT velocity, meters/second (SD) 1.50 (0.856) 1.78 (0.782) -0.28 0.32 The baseline imbalance observed is a direct consequence of a small study and should resolve in the larger GRAND CANYON cohort (n=120) Abbreviations: NSAA, North Star Ambulatory Assessment

18 Sevasemten was Well Tolerated: Overview of Treatment Emergent Adverse Events (TEAE) * A treatment emergent adverse event (TEAE) is any adverse event (AE) that starts during or after the first dose of investigational product through the end of the safety follow-up period Functional test Sevasemten (n=28) n (%) Placebo (n=12) n (%) Total (N=40) n (%) Any TEAE* 26 (92.9) 10 (83.3) 36 (90) Severe TEAE 0 (0) 0 (0) 0 (0) Serious Adverse Events 1 (3.6) 0 (0) 1 (2.5) Any drug related TEAE 16 (57.1) 5 (41.7) 21 (52.5) Discontinuation due to TEAE 1 (3.6) 0 (0) 1 (2.5) Deaths 0 (0) 0 (0) 0 (0)

19 Sevasemten was Well Tolerated: TEAEs Occurring in ≥5% of Total System Organ Class/Preferred Term Sevasemten (n=28) n (%) Placebo (n=12) n (%) Total (N=40) n (%) Any TEAE 26 (92.9%) 10 (83.3%) 36 (90%) Eye disorders Vision blurred 1 (3.6%) 2 (17%) 3 (8%) Gastrointestinal disorders Abdominal pain 1 (4%) 1 (8%) 2 (5.%) Vomiting 2 (7%) 0 (0%) 2 (5.%) General disorders and administration site conditions Fatigue 5 (18%) 3 (25%) 8 (20%) Chest discomfort 2 (7%) 0 (0%) 2 (5%) Influenza like illness 2 (7%) 0 (0%) 2 (5%) Infections and infestations COVID-19 6 (21%) 2 (17%) 8 (20%) Nasopharyngitis 6 (21%) 2 (17%) 8 (20.%) Upper respiratory tract infection 5 (18%) 2 (17%) 7 (18%) Influenza 4 (14%) 1 (8%) 5 (13%) Injury, poisoning and procedural complications Fall 8 (29%) 2 (17%) 10 (25%) Back injury 1 (4%) 1 (8%) 2 (5%) Investigations Ejection fraction decreased 0 (0%) 2 (17%) 2 (5%) Musculoskeletal and connective tissue disorders Arthralgia 2 (7%) 1 (8%) 3 (8%) Back pain 3 (11%) 0 (0%) 3 (8%) Osteopenia 2 (7%) 0 (0%) 2 (5%) Tendonitis 2 (7%) 0 (0%) 2 (5%) Nervous system disorders Headache 9 (32%) 2 (17%) 11 (28%) Dizziness 9 (32%) 0 (0%) 9 (23%) Somnolence 5 (18%) 1 (8%) 6 (15%) Migraine 3 (11%) 1 (8%) 4 (10%) Dizziness postural 2 (7%) 1 (8%) 3 (8%) Respiratory, thoracic and mediastinal disorders Oropharyngeal pain 4 (14%) 0 (0%) 4 (10%) Cough 3 (11%) 0 (0%) 3 (8%) Nasal congestion 2 (7%) 0 (0%) 2 (5%)

20 Statistically Significant Decrease in the Primary Endpoint of CK: 28% Reduction vs Placebo Note: CK values are log-transformed. LS (least squares) means, LS mean differences and CIs were back-transformed to percent scale Abbreviations: CFB, change from baseline, CI, confidence interval, CK, creatine kinase CK between-group difference LSMean: -28% (95% CI -44% to -6%); p-value = 0.02 Placebo Sevasemten -40 -20 0 20 40 % CFB CK (Avg 6-12 mo) 0 3 6 9 12 -50 0 50 100 Time (months) % CFB in CK Average 6 -12 months Sevasemten Placebo CK showed rapid and sustained decreases with sevasemten treatment

21 TNNI2 Decreased 77% from Baseline in the Sevasemten Treatment Group vs Placebo TNNI2 between-group difference LSMean: -77% (95% CI -89% to 51%); p-value < 0.001 Average 6 -12 months Sevasemten Placebo 0 3 6 9 12 -100 0 100 200 Time (months) % CFB in TNNI2 Placebo Sevasemten -100 -50 0 50 100 150 % CFB TNNI2 (Avg 6-12 mo) Note: TNNI2 values are log-transformed. LS means, LS mean differences and CIs were back-transformed to percent scale Abbreviations: CFB, change from baseline, CI, confidence interval, TNNI2, troponin I2 TNNI2, an on-target biomarker of fast muscle fiber damage, also demonstrated rapid and sustained decreases with sevasemten treatment

22 Key Secondary Endpoint: NSAA Remained Stable Over Time in Sevasemten Group 0 3 6 9 12 -3 -2 -1 0 1 2 Time (months) CFB Total NSAA Score NSAA between-group difference LSMean: 1.12 (95% CI -0.4 to 2.7); p-value = 0.16 Sevasemten Placebo Positive trends in NSAA favoring sevasemten with placebo declining in line with natural history Abbreviations: NSAA, North Star Ambulatory Assessment

23 63% of Patients Treated with Sevasemten Showed Stable or Improved Function After 12 Months Sevasemten NSAA Responder Analysis -6 -4 -2 2 4 6 -6 -4 -2 2 4 6 Placebo (n=12) Sevasemten (n=27) 63% 33% 67% 37% Stability or Improvement Odds Ratio: 3.4 (p=0.16) Abbreviations: NSAA, North Star Ambulatory Assessment

24 Trends in Other Functional Measures Favor Sevasemten Treatment Arm -4 -2 0 2 4 RFF Velocity 4SC Velocity 100MTT Velocity 10MWR Velocity NSAA Standardized Statistics (95% CI) 1.12 0.075 0.055 0.024 -0.005 LSMean Difference * At baseline, 9 sevasemten and 1 placebo treated participants were unable to rise from floor. At Month 12, 9 sevasemten and 2 placebo treated participants were unable to rise from floor Note: For the figures, LSM differences and CIs were standardized by dividing by the SE. LSM differences presented on the right of the figure are on original scale (without SE adjustment) * Favors Placebo Favors Sevasemten Abbreviations: NSAA, North Star Ambulatory Assessment, CI, confidence interval

25 Summary of Trial Results • Sevasemten treated patients showed stabilization of NSAA with trends toward improvement • Placebo group (n=12) declined in line with natural history • Primary endpoint achieved: 28% average decrease in CK versus placebo (p=0.02) • Plasma TNNI2 decreased 77% from baseline versus placebo (p<0.001) • Well-tolerated, at all doses, in adults and adolescents • No safety concerns identified • The imbalance between groups confounded interpretation of a few endpoints (e.g., MRI); evaluation of the full data set ongoing Safety Biomarkers Function Secondary & Exploratory Abbreviations: CK, creatine kinase, NSAA, North Star Ambulatory Assessment

Sevasemten Future Development Plans

27 9 15 Global, Multi-Center, Placebo-Controlled Pivotal Cohort Assessing Efficacy & Safety of Sevasemten in Becker Abbreviations: PO, by mouth; NSAA, North Star Ambulatory Assessment PRIMARY ENDPOINT NSAA at 18 months KEY INCLUSION CRITERIA Adult individuals with Becker with NSAA 5-32, not taking corticosteroids ENROLLMENT >120 Study design - 18 months 10mg PO daily Screening 0 1 3 6 Additional Endpoints Timed function tests (TFTs), biomarkers of muscle damage, MRI, patient reported outcomes (PROs), safety Month POTENTIAL REGISTRATIONAL COHORT 12 POWERED AT >90% for observing a difference corresponding to the natural history NSAA decline of 1.2 points/year Placebo R 2:1 18

28 GRAND CANYON Powered at 96% to Show a 1.68 Point NSAA Difference at 18 Months p<0.05 Treatment Difference Power Calculation Assumptions: • N=120 patients with 2:1 randomization • Month 12 CANYON treatment difference = 1.12 • Assumed 50% increase in NSAA treatment effect at month 18 vs month 12 ( = 1.68) • 10% drop-out rate • Standard deviation () = 2.16 • Tipping point = 0.87 (represents point where the p-value is ~0.05 given the study size and assumed standard deviation based on t-test) Power: 96% -2 -1 0 1 2 3 4 Abbreviations: NSAA, North Star Ambulatory Assessment

29 Sevasemten for Becker Next Steps *European sites include the UK, Netherlands, Belgium, Denmark, Spain, France, Germany and Italy Increased confidence in GRAND CANYON future success based on sevasemten clinical experience to date, Becker natural history data, and internal modeling CANYON results support engagement with FDA & EMA about marketing authorization filing strategies for sevasemten in Becker GRAND CANYON is near full enrollment in 51 sites across the United States, Europe*, New Zealand, Australia and Israel; on track to over-enroll by Q1 2025 1 2 To date, 99% of eligible Becker participants who have completed ARCH, CANYON, GRAND CANYON and DUNE have enrolled in MESA 3 4

CANYON Clinical Implications and Sevasemten’s Potential Role in Becker Dr. Craig M. McDonald

31 Reference: 1. Bello L, et al. 2016. 2. De Wel B, et al. Eur J Neurol. 2024. 3. Van de Velde NM, et al. Neurology. 2021.;4. Bello L et al 2024 WMS; 95% CI shown​ Natural History Data in Becker Support that Functional Decline, Measured by NSAA, is Consistent and Predictable 0 1 2 3 4 5 -10 -8 -6 -4 -2 0 Years of Observation Change in NSAA Natural history of Becker muscular dystrophy • NSAA is utilized in muscular dystrophy natural history studies to longitudinally assess function • Multiple natural history studies in individuals with Becker demonstrate a NSAA average score decline of 1.0 to 1.8 points annually . 1,2,3 • Becker Natural history studies support that NSAA decline is consistent in Becker patients who are already progressing

32 A Clinician’s Perspective on How to Interpret a 1-point NSAA Change in Becker From using the toilet independently… …to asking for help to get up from the toilet. …to requiring assistance from another person or mobility device. …to requiring someone else’s help to get back up. From using stairs or steps… From being able to get up from a fall… For individuals living with Becker, this decline could look like: Abbreviations: NSAA, North Star Ambulatory Assessment

Closing Remarks Kevin Koch, CEO

We Aim to Change the Lives of Individuals with Becker ~12,000 PEOPLE WITH BECKER IN US, EU-5 & JAPAN ~16 AGE PEOPLE WITH BECKER CAN BECOME MOBILITY DEVICE DEPENDENT • Source: Parent Project Muscular Dystrophy: Fifteen Year Registry Report; Edgewise Therapeutics independent quantitative and qualitative market research (Bluestar BioAdvisors); Edgewise research; Emery AE, Neuromuscul. Disord., 1991; MD STARnet Data and Statistics; Duchenne muscular dystrophy. National Center for Advancing Translational Sciences; Duan D et al., Nat. Rev. Dis. Primers, 2021 0 APPROVED THERAPIES

35 Abbreviations: HV, healthy volunteers; oHCM, obstructive hypertrophic cardiomyopathy; nHCM, non-obstructive hypertrophic cardiomyopathy; CV, cardiovascular; IND, Investigational New Drug application; POC, proof of concept Edgewise Upcoming Value-Generating Milestones H2 2024 H1 2025 H2 2025 Becker Duchenne Skeletal Sevasemten Hypertrophic Cardiomyopathy Cardiac EDG-7500 Phase 2 LYNX & FOX Controlled dose-ranging data Phase 3 trial Initiation Phase 2 CANYON 1-year placebo-controlled data Phase 1/Phase 2 EDG-7500 data in HVs & oHCM Phase 2 28-day study Initiate in oHCM & nHCM Phase 2 28-day study Initial Data readout ✓ ✓ GRAND CANYON Recruitment complete (Q1) Cardiometabolic Drug In vivo POC Phase 2 12-week oHCM & nHCM ✓ EDG-CV candidate IND in HF

36 As of September 30, 2024 Well-Capitalized to Execute Important Milestones Across Both EDG-7500 & Sevasemten (1) DEBT (1) $0 CASH, CASH EQUIVALENTS & MARKETABLE SECURITIES ~$493M COMMON SHARES OUTSTANDING (NASDAQ: EWTX) ~94M CASH RUNWAY THROUGH 2027

37 Q & A

Cover	Dec. 16, 2024
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