GlobeNewswire Inc | Sep 8, 2021 07:00AM EDT

September 08, 2021

CAMBRIDGE, Mass., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.(Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced the appointment of Mel Hayes as Chief Commercial Officer, effective September 7, 2021. Mr. Hayes will be responsible for delivering an integrated global strategy that fully maximizes the potential of Fulcrums transformative therapies.

We are very excited to welcome Mel to Fulcrum as we plan for important milestones with our development programs and FulcrumSeek, said Bryan Stuart, president and chief executive officer. Mel brings broad experience in building commercial organizations and launching products in markets around the world. His expertise positions Fulcrum well to build the commercial capabilities required to deliver transformative therapies that treat the root cause of genetically defined rare diseases.

With Fulcrums recent progress with losmapimod and FTX-6058, the company is ideally positioned to transition from a research and development-stage organization to a commercial-stage organization, said Mr. Hayes. I look forward to working with the experienced leadership team at Fulcrum, leveraging my extensive knowledge of commercialization strategies for therapies to treat rare diseases. Im excited about the great work already in motion as we aim to bring new and innovative treatmentsto patients around the world.

Mr. Hayes is an industry leader with more than 25 years of Global and U.S. experience in all areas of product commercialization including marketing, sales, new product planning, pricing and reimbursement, advocacy and patient engagement. Prior to Fulcrum, Mr. Hayes most recently served as Global Head Commercial, Vice President, Rare Blood Disorders at Sanofi-Genzyme where he led the global commercial organization for hemophilia and complement assets. He also served as U.S. Vice President Hemophilia and Global Head, Hematology Rare Blood Disorders at Bioverativ (acquired by Sanofi-Genzyme). Prior to Bioverativ, he served as Global Vice President, Head of Global Marketing and Launch Excellence at Shire and at Baxalta (acquired by Shire) as Global Vice President Hemophilia. Prior to Baxalta, Mr. Hayes spent 10 years and nine years at Bayer and Bristol Myers Squibb respectively in progressive commercial leadership roles where he was responsible for launching products in Diabetes, Cardiovascular Disease, Neurology, Rheumatology, Multiple Sclerosis and Parkinsons Disease.

Mr. Hayes earned dual bachelors degrees in Business and Communications from Southern Methodist University and an MBA from Columbia University.

About Fulcrum Therapeutics

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrums proprietary product engine, FulcrumSeek, identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The Company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD). Fulcrum has also advanced FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and beta-thalassemia, into Phase 1 clinical development.Please visit www.fulcrumtx.com.

Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the development status of the Companys product candidates, the potential advantages and therapeutic potential of Fulcrums product candidates and the Companys ability to transition from a research and development-stage organization to a commercial organization. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Companys strategy, future operations, future financial position, prospects, plans and objectives of management, are forward-looking statements. The words anticipate, believe, continue, could, estimate, expect, intend, may, plan, potential, predict, project, should, target, will, would and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with Fulcrums ability to obtain and maintain necessary approvals from the FDA and other regulatory authorities; continue to advance its product candidates in clinical trials; initiate and enroll clinical trials on the timeline expected or at all; correctly estimate the potential patient population and/or market for the Companys product candidates; replicate in clinical trials positive results found in preclinical studies and/or earlier-stage clinical trials of losmapimod, FTX-6058 and its other product candidates; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; obtain, maintain or protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Companys actual results to differ from those contained in the forward-looking statements, see the Risk Factors section, as well as discussions of potential risks, uncertainties and other important factors, in the Companys most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Companys views as of the date hereof and should not be relied upon as representing the Companys views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Companys views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

Contact:

Investors:Christi Waarich Director, Investor Relations and Corporate Communications617-651-8664cwaarich@fulcrumtx.com

Stephanie Ascher Stern Investor Relations, Inc.stephanie.ascher@sternir.com212-362-1200

Media:Kaitlin GallagherBerry & Company Public Relationskgallagher@berrypr.com212-253-8881