Fulcrum Therapeutics Inc. (FULC) Provides Business Update, 2023 Outlook

Fulcrum Therapeutics, Inc.^® (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today outlined its recent accomplishments and expected 2023 milestones.

“We are entering 2023 with a tremendous amount of momentum and expect it to be a productive year for our two clinical programs: FTX-6058 for SCD, and losmapimod for FSHD,” said Robert J. Gould, Ph.D., Fulcrum’s interim president and chief executive officer. “FTX-6058 is a potential best-in-class oral HbF inducer candidate that could address critical gaps in the SCD treatment landscape. We are excited by the levels of HbF induction in our initial doses and look forward to further broadening our understanding of its effect at a higher dose. Meanwhile, the Phase 3 REACH trial with losmapimod, a potential first-to-market therapy in FSHD, is expected to complete enrollment in the second half of the year.”

“We are encouraged by the new FTX-6058 data at 6 mg that show clinically relevant HbF increases, up to 9.5% from baseline with hemolysis and anemia improvement, suggesting its potential for best-in-class therapy for people living with sickle cell disease,” said Santiago Arroyo, M.D., Ph.D., Fulcrum’s chief medical officer.

Key Business Updates and Upcoming Milestones

FTX-6058

• Received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of SCD in December 2022
• Phase 1b data from Cohort 1 subjects in the 6 mg cohort (n=10) showed up to 9.5% absolute HbF increases from baseline; data suggest no difference in response in subjects on (n=3) and off (n=7) background hydroxyurea
• Improved biomarkers of hemolysis in evaluable patients dosed at 6 mg
• In the Phase 1b trial, FTX-6058 appears to have dose dependent and clinically relevant increases in HbF; all subjects adherent to dosing regimen showed a response
• Generally well tolerated with no drug-related treatment emergent serious adverse events and no discontinuations due to treatment emergent adverse events to date
• Enrolling 12 mg dose cohort of the Phase 1b trial
• Next data update planned during the fourth quarter of 2023

Losmapimod

• Enrollment ongoing in the REACH Phase 3 pivotal trial at sites in the U.S., Canada, and Europe
• Plan to complete enrollment in the second half of 2023

Financial Guidance

• Fulcrum maintains its cash runway guidance and expects its existing cash, cash equivalents, and marketable securities will be sufficient to fund its currently planned operating expenses and capital expenditure requirements into late 2024

Corporate

• Fulcrum announced CEO transition today; Robert J. Gould, Ph.D., former president and founding chief executive officer of Fulcrum has been appointed as interim CEO as Bryan Stuart departs to pursue other opportunities

J.P. Morgan Conference Webcast

• A live audio webcast of Fulcrum’s presentation at the 41st Annual J.P. Morgan Healthcare Conference will be available through the Investor Relations section of the Fulcrum website at https://ir.fulcrumtx.com/events-and-presentations. An archived replay will be available on Fulcrum’s website for 30 days.

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