Fulcrum Therapeutics Files 8-K

Ticker: FULC · Form: 8-K · Filed: Dec 8, 2025 · CIK: 1680581

Fulcrum Therapeutics, INC. 8-K Filing Summary
FieldDetail
CompanyFulcrum Therapeutics, INC. (FULC)
Form Type8-K
Filed DateDec 8, 2025
Risk Levellow
Pages6
Reading Time7 min
Key Dollar Amounts$0.001
Sentimentneutral

Sentiment: neutral

Topics: 8-K, disclosure, financials

TL;DR

Fulcrum Therapeutics filed an 8-K on 12/8/25 covering financial statements and other events.

AI Summary

Fulcrum Therapeutics, Inc. filed an 8-K on December 8, 2025, reporting on various events. The filing includes information related to financial statements and exhibits, as well as other events and a Regulation FD disclosure. The company is incorporated in Delaware and headquartered in Cambridge, Massachusetts.

Why It Matters

This 8-K filing provides an update on Fulcrum Therapeutics' corporate activities and disclosures, which is important for investors to monitor the company's compliance and operational status.

Risk Assessment

Risk Level: low — This filing is a routine corporate disclosure and does not appear to contain significant negative news or events.

Key Numbers

Key Players & Entities

FAQ

What specific events are being reported under 'Other Events' in this 8-K filing?

The provided text does not detail the specific events categorized under 'Other Events'.

Are there any financial statements included with this 8-K filing?

Yes, the filing explicitly lists 'Financial Statements and Exhibits' as an item of information.

What is the primary business of Fulcrum Therapeutics, Inc. according to the SIC code?

The Standard Industrial Classification (SIC) code provided is 2834, which corresponds to 'PHARMACEUTICAL PREPARATIONS'.

When was the earliest event reported in this 8-K filing?

The earliest event reported is dated December 08, 2025.

Where are Fulcrum Therapeutics, Inc.'s principal executive offices located?

The principal executive offices are located at 26 Landsdowne Street, Cambridge, Massachusetts, 02139.

Filing Stats: 1,738 words · 7 min read · ~6 pages · Grade level 12.9 · Accepted 2025-12-08 06:32:47

Key Financial Figures

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure On December 6, 2025, Fulcrum Therapeutics, Inc., or Fulcrum, issued a press release announcing initial results of the 20 mg dose cohort of the Phase 1b PIONEER trial of pociredir in sickle cell disease, or SCD, in connection with a presentation at the 67th American Society of Hematology Annual Meeting. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K. The information furnished in this Item 7.01, including Exhibit 99.1, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended, or the Securities Act. The information contained in this Item 7.01 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.

01 Other Events

Item 8.01 Other Events. On December 7, 2025, Fulcrum published a presentation announcing initial results of the 20 mg dose cohort of the Phase 1b PIONEER trial of pociredir in SCD in connection with a presentation at the 67th American Society of Hematology Annual Meeting. Results are as follows: Mean absolute fetal hemoglobin, or HbF, increased by 9.9% at 6 weeks of treatment with pociredir (vs. 5.6% at Week 6 and 8.6% at Week 12 in the 12 mg cohort), increasing from a baseline of 7.1% to 16.9%. As of the November 11, 2025 data cutoff, 7 of 12 patients (58%) achieved absolute HbF levels 20% at Week 6, and all patients demonstrated a robust HbF increase. HbF levels of 20% are associated with ~90% of patients experiencing zero vaso occlusive crisis, or VOCs, per year, based on real-world data presented by Fulcrum at the 20th Annual Sickle Cell & Thalassemia Conference in October 2025. A clear dose-response was observed, with a >3.75-fold mean induction of HbF at Week 12 among patients who reached the Week 12 visit as of the November 11, 2025 data cutoff (n=6), compared to a 2.4-fold mean induction at Week 12 in the 12 mg cohort. The average baseline for these six patients is 5.0% as compared to 7.1% for the full cohort. Fold induction accounts for differences in baseline HbF levels and enables a normalized comparison of dose-response. The proportion of F-cells (HbF-containing red blood cells) increased from a mean of 31% at baseline to 58% at Week 6 (n=9), indicating early progression toward pan-cellular HbF induction (evenly distributed across red blood cells). F-cells are resistant to sickling and hemolysis because of HbF-mediated inhibition of sickle hemoglobin (HbS) polymerization. Consequently, higher proportions of F-cells are associated with improved red blood cell health. Markers of hemolysis and erythropoiesis improved at Week 6: o Indirect bilirubin decreased by 37% (vs. 37% at Week 12 in the 12 mg cohort) o Lactate dehydrogenase decreased by 3

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this Current Report on Form 8-K are forward-looking statements, including, without limitation, express or implied statements regarding: the significance of initial results from the 20 mg cohort; Fulcrum's goals for pociredir; pociredir's best-in-class potential for the treatment of SCD; pociredir's ability to induce HbF, the durability or clinical relevance of early HbF and hemolysis improvements; VOCs during the 12-week treatment period; and Fulcrum's plans to submit an investigational new drug application; among others. Express or implied statements regarding Fulcrum's 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 management's 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 completing the 20mg cohort in the PIONEER clinical trial; achieving the same results in the full cohort as observed in a limited number of patients after six weeks; Fulcrum's ability to continue to advance pociredir and its other product candidates in clinical trials, including enrollment

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits 99.1+ Press Release issued December 6, 2025, announcing initial results from the 20 mg Dose Cohort of the Phase 1b PIONEER Trial of Pociredir in Sickle Cell Disease 99.2* Presentation issued December 7, 2025, announcing initial results from the 20 mg Dose Cohort of the Phase 1b PIONEER Trial of Pociredir in Sickle Cell Disease 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) + Furnished herewith. * Filed herewith.

SIGNATURES

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. FULCRUM THERAPEUTICS, INC. Date: December 8, 2025 By: /s/ Alex C. Sapir Name: Alex C. Sapir Title: President and Chief Executive Officer

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