Full Press Release Details
Edgewise Therapeutics Announces Appointment
of Michael Nofi as Chief Financial Officer, and the Retirement of Current CFO, R. Michael Carruthers
Boulder, Colo., (November 10, 2025) - Edgewise
Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company developing novel therapeutics for muscular
dystrophies and serious cardiac conditions, today announced the appointment of Michael Nofi, as Chief Financial Officer (CFO), effective
November 10, 2025. Mr. Nofi joins Edgewise after serving as Chief Accounting Officer (CAO) at SpringWorks Therapeutics, Inc.
Mr. Nofi will succeed Edgewise CFO, R. Michael Carruthers, who is retiring.
"As we enter a pivotal stage in our Company's evolution,
we are thrilled to welcome Michael Nofi to the Edgewise team," said Kevin Koch, Ph.D., President and Chief Executive Officer, Edgewise
Therapeutics. "Mr. Nofi brings extensive financial leadership experience in the biotech sector, with proven expertise driving
financial readiness for commercialization, which will be instrumental as we advance our late-stage development programs. I also want to
extend our sincere gratitude to Mr. Carruthers for his exceptional leadership and many contributions over the past five years, including
guiding Edgewise through our successful IPO and subsequent financings. We are deeply appreciative of his support during this transition
and wish him all the best in his well-deserved retirement."
Mr. Nofi brings over 30 years of leadership experience in finance
and accounting across public and private companies primarily in the life sciences sector, with extensive experience in scaling finance
operations, and supporting organizations through strategic growth, including commercialization. This comes at an important time as Edgewise
advances its late-stage clinical development while preparing for commercialization. Prior to joining Edgewise, Mr. Nofi served as
CAO of SpringWorks Therapeutics for six years where he directed financial operations, ensuring compliance, accurate reporting, and strategic
financial planning to support the business growth from an R&D organization to a global commercial company. Prior to SpringWorks, Mr. Nofi
was CAO and Vice President of Global Accounting and Corporate FP&A at The Nature's Bounty Co. Mr. Nofi also held senior
finance roles at Acorda Therapeutics, Allergan plc, and Forest Laboratories. Mr. Nofi holds a B.S. in accounting and an M.B.A. from
Villanova University and is a Certified Public Accountant.
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.
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
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 and EDG-15400; statements regarding Edgewise's ability to advance its late-stage clinical development programs
and commercialize its product candidates; 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; 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.
Behrad Derakhshan, Ph.D., Chief Operating Officer
Maureen Franco, VP Corporate Communications