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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 23, 2026

 

 

Fulcrum Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

001-38978

47-4839948

(State or other jurisdiction
of incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

26 Landsdowne Street

 

Cambridge, Massachusetts

 

02139

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (617) 651-8851

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common stock, par value $0.001 per share

 

FULC

 

Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 


Item 1.02 Termination of a Material Definitive Agreement.

On April 23, 2026, Fulcrum Therapeutics, Inc., or Fulcrum, provided written notice to CAMP4 Therapeutics Corp., or CAMP4, of termination of the License Agreement dated July 5, 2023, between Fulcrum and CAMP4, or the CAMP4 License, which termination will be effective in accordance with the terms of such agreement.

Under the CAMP4 License, Fulcrum received a worldwide exclusive license (including the right to sublicense) from CAMP4 to rights under its Diamond-Blackfan anemia program, including certain small molecule compounds, composition of matter and method of use patent rights, and know-how for Fulcrum to research, develop, manufacture, use, commercialize or otherwise exploit therapeutic products in any indication, including the grant of a sublicense under certain intellectual property rights that CAMP4 under an agreement with Children’s Medical Center Corporation, or CMCC.

Fulcrum made an undisclosed upfront non-refundable, non-creditable payment to CAMP4. Additionally, if Fulcrum had succeeded in developing and commercializing licensed products, CAMP4 would have been eligible to receive (i) up to $35.0 million in development and regulatory milestone payments and (ii) up to $35.0 million in sales milestone payments. CAMP4 also would have been eligible for royalty payments under the CAMP4 License.

The foregoing description of the terms of the CAMP4 License is qualified in its entirety by reference to the full text of the agreement, a copy of which was filed with the Securities and Exchange Commission as Exhibit 10.1 to Fulcrum’s Quarterly Report on Form 10-Q on November 7, 2023.

Item 2.02 Results of Operations and Financial Condition.

On April 27, 2026, Fulcrum announced its financial results for the quarter ended March 31, 2026. The full text of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Item 2.02, including Exhibit 99.1 attached hereto, shall not be deemed “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, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Appointment of Director

 

On April 23, 2026, the board of directors, or the Board, of Fulcrum, upon the recommendation of the Nominating and Corporate Governance Committee of the Board, appointed Josh Lehrer as a member of the Board, with immediate effect. Mr. Lehrer will serve as a Class III director with a term expiring at Fulcrum’s 2028 annual meeting of stockholders and thereafter until his successor has been duly elected and qualified or until his earlier death, resignation or removal. Mr. Lehrer was appointed to serve on the Science & Technology Committee. The Board has determined that Mr. Lehrer is “independent” as contemplated by the Nasdaq Stock Market and other governing laws and applicable regulations.

There are no arrangements or understandings between Mr. Lehrer and any other persons pursuant to which he was appointed as director. There are no transactions in which Mr. Lehrer has an interest requiring disclosure under Item 404(a) of Regulation S-K of the Securities Act of 1933, as amended.

Mr. Lehrer will receive compensation for his services as a non-employee director and for any committee service in accordance with Fulcrum’s non-employee director compensation policy, a summary of which was filed as Exhibit 10.16 to Fulcrum’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed with the Securities and Exchange Commission, or SEC, on February 24, 2026, including the automatic grant of a one-time nonqualified stock option under Fulcrum’s 2019 Stock Incentive Plan to purchase 64,000 shares of Fulcrum’s common stock, $0.001 par value per share at an exercise price per share equal to $8.08 per share, the closing price on the Nasdaq Global Market on April 23, 2026, the effective date of his appointment to the Board.

In connection with his appointment, Mr. Lehrer entered into Fulcrum’s standard form of indemnification agreement, a copy of which was filed as Exhibit 10.15 to Fulcrum’s Registration Statement on Form S-1 (File No. 333-232260) filed with the SEC on June 21, 2019. Pursuant to the terms of the indemnification agreement, Fulcrum may be required, among other things, to indemnify Mr. Lehrer for certain expenses (including attorneys’ fees), judgments, fines and settlement amounts actually and reasonably incurred by him in any action or proceeding arising out of his service as a member of the Board.


Retirement of Chief Financial Officer

On April 23, 2026, Alan Musso notified Fulcrum of his intent to retire as chief financial officer and treasurer (and as principal financial officer). Mr. Musso will remain in his current role until a successor is named and has agreed to serve as a consultant thereafter to assist with an orderly transition. Fulcrum intends to conduct an executive search to identify a replacement for Mr. Musso.

In recognition of Mr. Musso’s service and agreement to remain in his current role while his successor is identified and to be available to advise Fulcrum to ensure a smooth transition, Mr. Musso’s retirement will be treated as an ending pursuant to Section 7(b) of his employment agreement dated August 7, 2023, or the Employment Agreement. Accordingly, in connection with his retirement, Fulcrum and Mr. Musso entered into a Transition Agreement, or the Transition Agreement, effective April 27, 2026, providing for transition benefits outside of the change in control period as described in the summary of the Employment Agreement included in Fulcrum’s definitive proxy statement on Schedule 14A filed with the SEC on April 30, 2025, which description is incorporated herein by reference. Mr. Musso also agreed to be available to provide consulting services through February 2027. In addition, Fulcrum agreed to extend the post-termination exercise period for vested stock options by twelve months following the end of his consulting services. Mr. Musso’s departure is not related to any disagreement between the parties as to the management of Fulcrum or as to any matter relating to its operations, policies or practices.

The foregoing description of the Transition Agreement does not purport to be a complete description of the rights and obligations of the parties thereunder and is qualified in its entirety by reference to the full text of the Transition Agreement, a copy of which Fulcrum intends to file with the SEC as an exhibit to its Quarterly Report on Form 10-Q for the quarter ending June 30, 2026.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

The following exhibit is furnished herewith:

 

10.1†

License Agreement, effective as of July 5, 2023, by and between CAMP4 Therapeutics Corp. and Fulcrum Therapeutics, Inc. (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 2023).

99.1

Press Release issued April 27, 2026, announcing financial results for the quarter ended March 31, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

† Certain portions of this exhibit have been omitted because the registrant has determined that they are both not material and is the type of information that the registrant treats as private or confidential.

+ Furnished herewith.

 


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:

April 27, 2026

By:

/s/ Alex C. Sapir

 

 

 

Name: Alex C. Sapir
Title: President and Chief Executive Officer

 


EX-99.1 2 fulc-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

 

img189780767_0.jpg

 

 

Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results

for First Quarter 2026

― Presented positive clinical data for pociredir, demonstrating robust and rapid fetal hemoglobin (HbF) induction, improvements in markers of hemolysis and anemia, and encouraging trends in vaso-occlusive crisis (VOC) reduction ―

― Fulcrum plans to initiate a potential registration-enabling trial in the second half of 2026 ―

― Dosed first patient in an open-label, long-term dosing trial evaluating the long-term safety and durability of response to pociredir in participants previously enrolled in the PIONEER trial ―

 

― Appointed Josh Lehrer, M.D., M.Phil., FACC, an experienced leader in sickle cell disease drug development, to the Board of Directors ―

 

― Chief Financial Officer, Alan Musso plans to retire later this year and will continue in his role until a successor is named ―

 

― Ended the first quarter of 2026 with $333.3 million in cash, cash equivalents, and marketable securities; cash runway into 2029 ―

CAMBRIDGE, Mass., – April 27, 2026 – Fulcrum Therapeutics, Inc.® (Fulcrum) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules that improve the lives of patients with rare hematological disorders, today reported financial results for the first quarter of 2026 and provided a business update.

“The strength of the clinical data presented in the first quarter further reinforce our conviction in pociredir’s potential to address the underlying biology of sickle cell disease,” said Alex C. Sapir, Fulcrum’s President and Chief Executive Officer. “The magnitude of HbF induction and improvements in markers of hemolysis and anemia observed to date support our upcoming discussions with the FDA as we prepare for a potential registration-enabling study in the second half of 2026. With a strong balance sheet extending our cash runway into 2029, we are well positioned to advance pociredir through the next phase of clinical development.”

 

“I am also pleased to welcome Dr. Josh Lehrer to Fulcrum’s Board of Directors. Josh’s track record advancing transformative therapies for patients with sickle cell disease, most notably his experience with the development and approval of Oxbryta®, will be invaluable as we advance pociredir into the next phase of development. I would also like to thank Alan Musso, who will be retiring as CFO this year, for his years of dedication and unwavering commitment to Fulcrum’s success. During his tenure, he not only strengthened Fulcrum’s balance sheet through our recent financing, but also provided important strategic perspectives and instilled strong financial discipline across the organization.”

Recent Business Highlights

Presented positive clinical data from the 20 mg dose cohort of the Phase 1b PIONEER trial of pociredir in sickle cell disease (SCD) during the first quarter of 2026, demonstrating robust and rapid HbF induction, progression toward pan-cellular distribution, improvements in markers of hemolysis and anemia, and encouraging trends in VOC reduction. Pociredir continues to be generally well-tolerated, with no treatment-related serious adverse events reported to date.
Fulcrum expects to provide an update on the design of its next trial in the second quarter of 2026 following receipt of meeting minutes from its End-of-Phase meeting with the U.S. Food and Drug Administration (FDA). Pending feedback from the FDA, Fulcrum plans to initiate a potential registration-enabling trial in the second half of 2026.
Dosed first patient in an open-label, long-term dosing trial designed to evaluate the long-term safety and durability of response to pociredir in participants previously enrolled in the Phase 1b PIONEER trial.
An abstract from the Phase 1b PIONEER trial of pociredir in sickle cell disease has been accepted for oral presentation at the Foundation for Sickle Cell Disease Research Symposium 2026, to be held in June 2026, featuring previously disclosed clinical data.

Announced a patient-focused collaboration with MedicAlert Foundation and the Sickle Cell Disease Association of America to help improve access to patient-specific care information in emergency department settings for individuals living with sickle cell disease.
Chief Financial Officer Alan Musso plans to retire later this year to spend more time with his family and other outside interests. Mr. Musso will remain in his role until a successor is named and has agreed to serve as a consultant thereafter to support a seamless transition. Fulcrum will initiate a search to identify a successor.

First Quarter 2026 Financial Results

Cash Position: As of March 31, 2026, cash, cash equivalents, and marketable securities were $333.3 million, compared to $352.3 million as of December 31, 2025. The decrease of $19.0 million was primarily due to cash used to fund operating activities in 2026.
R&D Expenses: Research and development expenses were $14.1 million for the three months ended March 31, 2026, compared to $13.4 million for the three months ended March 31, 2025. The increase of $0.7 million was primarily due to higher employee compensation costs, including $0.4 million of increased stock-based compensation expense.
G&A Expenses: General and administrative expenses were $8.1 million for the three months ended March 31, 2026, compared to $7.0 million for three months ended March 31, 2025. The increase of $1.1 million was primarily driven by higher employee compensation costs, including $0.3 million of increased stock-based compensation expense, as well as higher professional services costs.
Net Loss: Net loss was $18.9 million for the three months ended March 31, 2026, compared to a net loss of $17.7 million for the three months ended March 31, 2025.

 

Cash Runway Guidance

Based on its current operating plans, Fulcrum expects that its current cash, cash equivalents, and marketable securities will be sufficient to fund its operating requirements into 2029.

 

About Fulcrum Therapeutics
Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecules that improve the lives of people with rare hematological disorders. The company’s lead clinical program is pociredir, a small molecule designed to increase expression of fetal hemoglobin (HbF) for the treatment of sickle cell disease (SCD). Fulcrum uses proprietary technology to identify drug targets that can modulate gene expression to treat the known root cause of genetically defined diseases. For more information, visit www.fulcrumtx.com and follow us on X (@FulcrumTx) and LinkedIn.

About Pociredir
Pociredir is an investigational oral small-molecule inhibitor of Embryonic Ectoderm Development (EED) that was discovered using Fulcrum’s proprietary discovery technology. Inhibition of EED leads to potent downregulation of key fetal globin repressors, including BCL11A, thereby causing an increase in HbF. Pociredir is being developed for the treatment of SCD. In the PIONEER Phase 1b clinical trial in people with SCD, pociredir has demonstrated dose-dependent increases in HbF, pan-cellular HbF induction, and improvements in markers of hemolysis and anemia. Across the 12 mg and 20 mg dose cohorts, pociredir has been generally well-tolerated with up to three months of exposure, with no treatment-related serious adverse events reported through the December 23, 2025 data cutoff date. Pociredir has been granted Fast Track and Orphan Drug Designation from the FDA for the treatment of SCD. To learn more about clinical trials of pociredir please visit ClinicalTrials.gov.

About Sickle Cell Disease
SCD is a genetic disorder of the red blood cells caused by a mutation in the HBB gene. This gene encodes a protein that is a key component of hemoglobin, a protein complex whose function is to transport oxygen in the body. The result of the mutation is less efficient oxygen transport and the formation of red blood cells that have a sickle shape. These sickle shaped cells are much less flexible than healthy cells and can block blood vessels or rupture cells. People with SCD typically suffer from serious clinical consequences, which may include anemia, pain, infections, stroke, heart disease, pulmonary hypertension, kidney failure, liver disease, and reduced life expectancy.


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. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, including express or implied statements regarding Fulcrum’s clinical development of pociredir, including the open-label extension trial, discussions with and receipt of feedback from regulators on trial design, and commencing a registrational trial; the potential of pociredir to increase HbF to levels that could ameliorate symptoms of SCD and transform the standard of care and Fulcrum’s projected cash runway, among others. 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 Fulcrum’s ability to continue to advance pociredir and any other product candidates in clinical trials, including progressing early stage candidates into the clinic; initiating and enrolling clinical trials on the timeline expected or at all; including receiving feedback from, and obtaining and maintaining necessary approvals from the FDA and other regulatory authorities; replicating in clinical trials positive results found in preclinical studies and/or earlier-stage clinical trials; obtaining, maintaining or protecting intellectual property rights related to its product candidates; managing expenses; and raising the substantial additional capital needed to achieve its business objectives, among others. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Fulcrum’s 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 Fulcrum’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Fulcrum’s views as of the date hereof and should not be relied upon as representing Fulcrum’s views as of any date subsequent to the date hereof. Fulcrum anticipates that subsequent events and developments will cause Fulcrum’s views to change. However, while Fulcrum may elect to update these forward-looking statements at some point in the future, Fulcrum specifically disclaims any obligation to do so.

 

 

 


Fulcrum Therapeutics, Inc.

Selected Consolidated Balance Sheet Data

(In thousands)

(Unaudited)

 

 

 

March 31,
2026

 

 

December 31,
2025

 

Cash, cash equivalents, and marketable securities

 

$

333,316

 

 

$

352,306

 

Working capital(1)

 

 

328,805

 

 

 

344,432

 

Total assets

 

 

346,770

 

 

 

366,284

 

Total stockholders’ equity

 

 

333,303

 

 

 

349,000

 

(1) Fulcrum defines working capital as current assets minus current liabilities.


Fulcrum Therapeutics, Inc.

Consolidated Statements of Operations

(In thousands, except per share data)

(Unaudited)

 

 

 

Three Months Ended
March 31,

 

 

 

2026

 

 

2025

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

 

14,084

 

 

 

13,404

 

General and administrative

 

 

8,102

 

 

 

6,999

 

Total operating expenses

 

 

22,186

 

 

 

20,403

 

Loss from operations

 

 

(22,186

)

 

 

(20,403

)

Other income, net

 

 

3,295

 

 

 

2,748

 

Net loss

 

$

(18,891

)

 

$

(17,655

)

Net loss per share, basic and diluted

 

$

(0.25

)

 

$

(0.28

)

Weighted-average common shares outstanding, basic and diluted

 

 

76,215

 

 

 

62,479

 

 

Contact:


Kevin Gardner

LifeSci Advisors, LLC

kgardner@lifesciadvisors.com

617-283-2856