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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): December 10, 2024

 

NextCure, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware
(State or other jurisdiction of incorporation)

 

001-38905
(Commission File Number)

 

47-5231247
(IRS Employer Identification No.)

 

 

9000 Virginia Manor Road, Suite 200

Beltsville, Maryland

 

20705

(Address of principal

 

(Zip Code)

executive offices)

 

 

 

Registrant's telephone number, including area code: (240) 399-4900

  

(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, $0.001 par value per share

NXTC

Nasdaq Global Select 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 8.01 Other Events

On December 10, 2024, NextCure, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration accepted an Investigational New Drug application for initiation of a Phase 1 clinical trial to evaluate LNCB74, a B7-H4-targeting antibody-drug conjugate as a therapeutic for treating multiple cancers.

A copy of this press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01Financial Statements and Exhibits

(d) Exhibits.

Exhibit

No.

Description

99.1

Press Release dated December 10, 2024

104

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

SIGNATURE

 

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.

 

 

November

Dated: December 10, 2024

NEXTCURE, INC.

 

 

 

 

By:

/s/ Steven P. Cobourn

 

Name:

Steven P. Cobourn

 

Title:

Chief Financial Officer

Exhibit 99.1

Graphic

NextCure Announces Acceptance of IND Application for LNCB74

LNCB74 is a B7-H4-targeting antibody-drug conjugate being developed for multiple cancers in partnership with LigaChem Biosciences

BELTSVILLE, Md. – December 10 , 2024 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) application for initiation of a Phase 1 clinical trial to evaluate LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers.

“Acceptance of the IND application for LNCB74 represents an important milestone for NextCure as we focus our resources on advancing our ADC program,” said Michael Richman, NextCure’s president and CEO. “The IND application leverages LNCB74 preclinical data that highlights the differentiation of our B7-H4 ADC from other ADCs targeting B7-H4. We believe LNCB74 has the potential to transform treatment for patients and we look forward to advancing LNCB74 into clinical development.”

An IND is a request submitted to the regulatory authorities seeking permission to test a new drug or therapeutic substance in humans. The IND includes detailed information about the drug, its composition, pharmacology, toxicology, data from preclinical studies, proposed clinical trial protocols, and information on manufacturing and quality control. With the IND application acceptance now complete, NextCure can proceed with the Phase I trial.

LNCB74 is being developed in partnership with LigaChem Biosciences, Inc. as part of a collaboration and co-development agreement.

About NextCure, Inc.

NextCure is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or have disease progression on, current therapies, through the use of differentiated mechanisms of actions including antibody-drug conjugates, antibodies and proteins. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. www.nextcure.com


Forward-Looking Statements

Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “continue,” “could,” “should,” “due,” “estimate,” “expect,” “intend,” “hope,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “target,” “towards,” “forward,” “later,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language.

Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and not having any products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and in NextCure’s other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change.

Investor Inquiries

Timothy Mayer, Ph.D.

NextCure, Inc.

Chief Operating Officer

(240) 762-6486

IR@nextcure.com


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Document and Entity Information
Dec. 10, 2024
Document and Entity Information [Abstract]  
Document Type 8-K
Document Period End Date Dec. 10, 2024
Entity Registrant Name NextCure, Inc.
Entity Incorporation, State or Country Code DE
Entity File Number 001-38905
Entity Tax Identification Number 47-5231247
Entity Address, Address Line One 9000 Virginia Manor Road
Entity Address, Adress Line Two Suite 200
Entity Address, City or Town Beltsville
Entity Address State Or Province MD
Entity Address, Postal Zip Code 20705
City Area Code 240
Local Phone Number 399-4900
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Soliciting Material false
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Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.001 par value per share
Trading Symbol NXTC
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period false
Entity Central Index Key 0001661059
Amendment Flag false

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