0000950170-22-016633.txt : 20220811 0000950170-22-016633.hdr.sgml : 20220811 20220811070208 ACCESSION NUMBER: 0000950170-22-016633 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20220811 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Cost Associated with Exit or Disposal Activities ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220811 DATE AS OF CHANGE: 20220811 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Fulcrum Therapeutics, Inc. CENTRAL INDEX KEY: 0001680581 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 474839948 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38978 FILM NUMBER: 221153617 BUSINESS ADDRESS: STREET 1: 26 LANDSDOWNE STREET CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 617-651-8851 MAIL ADDRESS: STREET 1: 26 LANDSDOWNE STREET CITY: CAMBRIDGE STATE: MA ZIP: 02139 8-K 1 fulc-20220811.htm 8-K 8-K
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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): August 11, 2022

 

 

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

 

Not applicable

(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 2.02 Results of Operations and Financial Condition.

On August 11, 2022, Fulcrum Therapeutics, Inc., or Fulcrum, announced its financial results for the quarter ended June 30, 2022. 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, 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 2.05 Costs Associated with Exit or Disposal Activities

On August 11, 2022, Fulcrum also announced the approval by its board of directors of a plan to strategically realign its operations and implement cost reduction measures to prioritize its two clinical programs. Fulcrum plans to streamline its research and development activities and redeploy resources to focus on its two development-stage programs that are expected to drive near-term value. The realignment plan will result in a reduction of 18 positions primarily in the areas of discovery, research and general and administrative. Fulcrum expects to complete the workforce reduction in August 2022.

The realignment plan is expected to result in savings in operating expenses of approximately $40-$50 million, which is expected to be fully realized by mid-2024. Fulcrum currently estimates that it will incur cash charges of approximately $0.4-$0.5 million related to the realignment plan consisting of one-time termination benefits. The charges Fulcrum expects to incur in connection with this reduction in force are subject to a number of assumptions, risks and uncertainties, and actual results may materially differ. Fulcrum may also incur other material charges not currently contemplated due to events that may occur as a result of, or associated with, these actions.

 

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 facts, contained in this report are forward-looking statements, including statements regarding the strategic operational realignment, estimated cost savings, estimated charges and Fulcrum’s 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 realize the cost savings from the realignment; continue to advance its product candidates in clinical trials; initiate and enroll clinical trials on the timeline expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; 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; 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 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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

The following exhibit is furnished herewith:

 

99.1

Press Release issued August 11, 2022

104

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

 

 

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 thereunto duly authorized.

 

 

 

FULCRUM THERAPEUTICS, INC.

 

 

 

 

Date:

August 11, 2022

By:

/s/ Bryan Stuart

 

 

 

Name: Bryan Stuart
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 Second Quarter 2022 Financial Results

and Business Update

 

– Presented initial data from Phase 1b trial in sickle cell disease (SCD), which demonstrate rapid and robust increases in hemoglobin F (HbF); supports proof-of-concept that FTX-6058 is a novel oral HbF inducer –

– Announced enrollment of first patient in Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD); first ever Phase 3 trial in this disease –

– Announced strategic realignment to reduce operating expenses by $40-50M, prioritize clinical execution, and extend cash runway into mid-2024 –

– Conference call scheduled for 8:00 a.m. ET today –

 

CAMBRIDGE, Mass. – August 11, 2022 – Fulcrum Therapeutics, Inc.® (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today reported financial results for the second quarter of 2022 and announced a strategic plan to realign internal resources to support the two clinical programs that are expected to be the key drivers of near-term value and extend cash runway.

 

“In the second quarter, we achieved major milestones in both of our clinical programs,” said Bryan Stuart, Chief Executive Officer of Fulcrum Therapeutics. “We demonstrated compelling proof of concept data for 6058 and initiated the first registrational trial for FSHD. Our strategic refocus will better position us to continue to advance our exciting pipeline and deliver on our unwavering commitment to patients with genetically defined rare diseases.”

 

Key Business Updates

 

FTX-6058

•
Announced data from initial patients in first cohort of Phase 1b trial of FTX-6058 in SCD; achieved HbF increases of up to 6.3% over baseline, showing proof-of-concept for FTX-6058 as an oral HbF inducer.
•
Enrolling new patients in 6mg and 2mg dose cohorts of Phase 1b SCD trial, including patients both on and off hydroxyurea.
•
Planning to initiate additional cohort at higher dose; expect to complete enrollment in three dose cohorts by end of 2022.
•
Planning to initiate registrational trial in 2023.
•
Delaying initiation of Phase 1b trial in non-SCD hemoglobinopathies, including beta-thalassemia.

 

Losmapimod

•
Enrolled first patient in REACH pivotal Phase 3 trial in FSHD.
•
Registrational trial will include over 30 sites in the U.S., EU, U.K., and Canada.

 

Preclinical Pipeline

•
Planning to submit next Investigational New Drug application (IND) in 2023.

 

Organizational Changes

•
Announced strategic plan to realign internal investments and operations to prioritize the two clinical programs that are expected to be the key drivers of near-term value and extend cash runway into mid-2024.
•
Business realignment will streamline research and discovery efforts, expected to result in savings of $40-50M into mid-2024.
•
Announced workforce reduction of 25% of planned headcount, primarily in discovery, research, and general & administrative (G&A).
•
Announced the promotion of Mel Hayes to the role of Chief Operating Officer. Mel will assume responsibility for corporate operations, in addition to his current commercial responsibilities. Mel joined Fulcrum in September 2021 as Chief Commercial Officer.
•
Announced the promotion of Curt Oltmans to the role of Chief Legal Officer. Curt previously served as Fulcrum's Senior Vice President and General Counsel. Curt joined Fulcrum in November 2020.

Second Quarter 2022 Financial Results

•
Cash Position: As of June 30, 2022, cash, cash equivalents, and marketable securities were $169.0 million, as compared to $218.2 million as of December 31, 2021. Based on current operating plans, including successful implementation of the operational realignment, Fulcrum expects that its existing cash, cash equivalents, and marketable securities will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into mid-2024.
•
Collaboration Revenue: Collaboration revenue was $1.9 million for the second quarter of 2022, as compared to $4.4 million for the second quarter of 2021. The decrease of $2.5 million was primarily due to the winding down of Fulcrum's collaboration agreement with Acceleron Pharma Inc., a wholly owned subsidiary of Merck & Co., Inc.
•
R&D Expenses: R&D expenses were $25.0 million for the second quarter of 2022, as compared to $17.4 million for the second quarter of 2021. The increase of $7.6 million was primarily due to a $5.0 million milestone payable to GlaxoSmithKline plc, upon the initiation of the Phase 3 REACH trial under the pre-existing right of reference and license agreement.
•
G&A Expenses: G&A expenses were $11.1 million for the second quarter of 2022, as compared to $6.7 million for the second quarter of 2021. The increase of $4.4 million was primarily due to increased employee-related costs to support the growth of the organization and increased professional services due to increased use of consulting services and preparatory commercial activities.
•
Net Loss: Net loss was $34.1 million for the second quarter of 2022, as compared to a net loss of $19.6 million for the second quarter of 2021.

 

Conference Call and Webcast

Fulcrum Therapeutics, Inc. will host a conference call and webcast today at 8:00 a.m. ET to discuss its second quarter 2022 recent business highlights and financial results. The webcast will be accessible through the Investor Relations section of Fulcrum’s website at www.fulcrumtx.com. Following the live webcast, an archived replay will also be available for 90 days.

Dial-in Number

U.S./Canada Dial-in Number: 1-833-634-2546
International Dial-in Number: 1-412-902-4190
Conference ID: 7096297

 

Replay Dial-in Number: 1-877-344-7529
Replay International Dial-in Number: 1-412-317-0088
Conference ID: 7096297

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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. Fulcrum’s two lead programs in clinical development are losmapimod, a small molecule for the treatment of facioscapulohumeral muscular dystrophy (FSHD), and FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies, including beta-thalassemia. Fulcrum’s proprietary product engine, FulcrumSeek™, identifies drug targets that can modulate gene expression to treat the known root cause of gene mis-expression. For more information, visit www.fulcrumtx.com and follow us on Twitter @FulcrumTx and LinkedIn.

 

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 statements regarding the strategic operational realignment and impact on operating expenses, research and discovery efforts, cost savings, Fulcrum’s cash runway, and ability to achieve near term objectives and deliver on its long-term vision; completion of enrollment in the Phase 1b SCD trial of FTX-6058, as well as enrollment in three dose cohorts; timing of registration trial of FTX-6058 in SCD as well as timing for Phase 1b trial in other hemoglobinopathies; the REACH trial; timing of submission of next IND; 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 its product candidates in clinical trials; initiate and enroll clinical trials on the timeline expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; 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; obtain, maintain or protect intellectual property rights related to its product candidates; manage expenses; realize the anticipated benefits of the strategic realignment; 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 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)

 

 

 

June 30,
2022

 

 

December 31,
2021

 

Cash, cash equivalents, and marketable securities

 

$

168,973

 

 

$

218,162

 

Working capital(1)

 

 

152,126

 

 

 

206,799

 

Total assets

 

 

195,233

 

 

 

235,000

 

Total stockholders’ equity

 

 

160,755

 

 

 

211,539

 

(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
June 30,

 

 

Six Months Ended
June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Collaboration revenue

 

$

1,882

 

 

$

4,381

 

 

$

4,474

 

 

$

9,170

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

25,019

 

 

 

17,378

 

 

 

42,850

 

 

 

33,712

 

General and administrative

 

 

11,098

 

 

 

6,685

 

 

 

21,857

 

 

 

12,183

 

Total operating expenses

 

 

36,117

 

 

 

24,063

 

 

 

64,707

 

 

 

45,895

 

Loss from operations

 

 

(34,235

)

 

 

(19,682

)

 

 

(60,233

)

 

 

(36,725

)

Other income, net

 

 

165

 

 

 

34

 

 

 

235

 

 

 

78

 

Net loss

 

$

(34,070

)

 

$

(19,648

)

 

$

(59,998

)

 

$

(36,647

)

Net loss per share, basic and diluted

 

$

(0.83

)

 

$

(0.60

)

 

$

(1.47

)

 

$

(1.14

)

Weighted-average common shares outstanding, basic and diluted

 

 

40,890

 

 

 

32,636

 

 

 

40,768

 

 

 

32,076

 

 

Contact:

Investors:

Stephanie Ascher

Stern Investor Relations, Inc.

stephanie.ascher@sternir.com

212-362-1200

 

Media:

Dee Smith

Executive Director, Corporate Communications

Fulcrum Therapeutics, Inc.

dsmith@fulcrumtx.com

202-746-1324

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Entity Tax Identification Number 47-4839948
Entity Address, Address Line One 26 Landsdowne Street
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Trading Symbol FULC
Security Exchange Name NASDAQ
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