Fulcrum Therapeutics, Inc.

Fulcrum Therapeutics, Inc. approved cash retention payments for its nine remaining full-time employees, including key executives Alex C. Sapir (President and CEO), Curtis Oltmans (Chief Legal Officer), and Alan Musso (CFO), following a previously disclosed restructuring plan. These payments are contingent upon a Change in Control or termination without Cause, provided transitional duties are met. Additionally, the company extended "Change in Control" benefits to all remaining employees at the Vice President level and above. Separately, Greg Tourangeau, Vice President, Finance, and principal accounting officer, will depart from his position by mutual agreement.

Fulcrum Therapeutics, Inc. announced a significant restructuring plan, approved on May 31, 2026, to reduce operating expenses and preserve capital following the discontinuation of pociredir development for sickle cell disease. The plan involves an approximately 85% reduction in its workforce, from 57 to 9 full-time employees, and is expected to incur charges of about $4.2 million. Concurrently, Fulcrum has initiated a comprehensive review of strategic alternatives, including potential mergers, acquisitions, or asset sales, and has engaged Leerink Partners LLC as its financial advisor.

Fulcrum Therapeutics announced the discontinuation of its pociredir program for sickle cell disease following FDA feedback on potential malignancy risks, linking it to the global withdrawal of Tazverik®. The FDA concluded that all PRC2 complex inhibitors carry equivalent malignancy risk, leaving no viable regulatory path for pociredir. Consequently, Fulcrum has initiated a comprehensive review of strategic alternatives to maximize stockholder value and will significantly reduce operating expenses.

Fulcrum Therapeutics announced the discontinuation of its pociredir program for sickle cell disease (SCD) following FDA feedback. The FDA raised concerns about potential malignancy risk associated with PRC2 complex inhibition, citing issues with Tazverik®, another PRC2 inhibitor that was globally withdrawn. Despite pociredir showing robust elevations in fetal hemoglobin and being well-tolerated, the FDA's stance left no viable regulatory path. Consequently, Fulcrum will explore strategic alternatives to maximize stockholder value and is reducing operating expenses.

Fulcrum Therapeutics, Inc. granted 55,500 non-statutory stock options to two new employees as an inducement to employment, in accordance with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $7.02 per share, matching the closing price on the May 4, 2026 grant date. These options vest over four years, with 25% vesting on the first anniversary and the remainder in equal quarterly installments over the subsequent three years, subject to continued service.

Fulcrum Therapeutics, Inc. announced its 2026 Annual Meeting of Stockholders will be held virtually on June 24, 2026. Stockholders of record as of April 27, 2026, are eligible to vote on the election of three Class I directors, a non-binding advisory vote on executive compensation, and the ratification of Ernst & Young LLP as the independent auditor for 2026. The board of directors recommends voting in favor of all proposals.

Fulcrum Therapeutics reported a net loss of $(18.9) million for Q1 2026, an increase from $(17.7) million in Q1 2025, bringing its accumulated deficit to $(613.2) million. The company continues to incur significant losses and expects this trend to persist, necessitating substantial additional funding to support its clinical development of pociredir and other product candidates. Cash, cash equivalents, and marketable securities are projected to fund operations for at least 12 months.

Fulcrum Therapeutics reported Q1 2026 financial results, ending the quarter with $333.3 million in cash, cash equivalents, and marketable securities, providing a cash runway into 2029. The company presented positive clinical data for pociredir in sickle cell disease, showing robust fetal hemoglobin induction and improvements in hemolysis and anemia markers, with plans to initiate a potential registration-enabling trial in H2 2026. Additionally, Fulcrum terminated its license agreement with CAMP4 Therapeutics for the Diamond-Blackfan anemia program and announced the retirement of CFO Alan Musso later this year, while appointing Josh Lehrer to the Board of Directors.

Fulcrum Therapeutics reported positive clinical data for pociredir in sickle cell disease, showing robust fetal hemoglobin induction and improvements in hemolysis and anemia markers, with encouraging trends in VOC reduction. The company plans to initiate a potential registration-enabling trial in the second half of 2026 and has dosed the first patient in a long-term safety trial. Additionally, Josh Lehrer, M.D., was appointed to the Board, and CFO Alan Musso announced his retirement. Fulcrum ended Q1 2026 with $333.3 million in cash, extending its cash runway into 2029.

Fulcrum Therapeutics, Inc. announced the appointment of Josh Lehrer, M.D., M.Phil., FACC, as an independent director to its Board of Directors. Dr. Lehrer brings over two decades of clinical development experience, including leadership in the development and approval of Oxbryta for sickle cell disease. His expertise in rare disease drug development is expected to be invaluable as Fulcrum advances its lead program, pociredir, for sickle cell disease.