0001104659-22-086121.txt : 20220804 0001104659-22-086121.hdr.sgml : 20220804 20220804160630 ACCESSION NUMBER: 0001104659-22-086121 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20220804 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220804 DATE AS OF CHANGE: 20220804 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NextCure, Inc. CENTRAL INDEX KEY: 0001661059 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 475231247 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38905 FILM NUMBER: 221136502 BUSINESS ADDRESS: STREET 1: 9000 VIRGINIA MANOR ROAD, SUITE 200 CITY: BELTSVILLE STATE: MD ZIP: 20705 BUSINESS PHONE: 240-399-4900 MAIL ADDRESS: STREET 1: 9000 VIRGINIA MANOR ROAD, SUITE 200 CITY: BELTSVILLE STATE: MD ZIP: 20705 8-K 1 tm2222578d1_8k.htm FORM 8-K

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 4, 2022

NextCure, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-38905		47-5231247
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

9000 Virginia Manor Road, Suite 200

Beltsville, Maryland

20705

(Address of principal
executive offices)

(Zip Code)

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 x

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 4, 2022, NextCure, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2022. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1.

The information furnished in this Item 2.02 (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 (the “Exchange Act”), or otherwise subject to the liabilities of that section, and is not incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01.

Financial Statements and Exhibits

(d) Exhibits.

Exhibit

No.

Description

99.1

Press release issued by NextCure, Inc. dated August 4, 2022

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.

Dated: August 4, 2022	NEXTCURE, INC.

	By:	/s/ Steven P. Cobourn
	Name:	Steven P. Cobourn
	Title:	Chief Financial Officer

EX-99.1 2 tm2222578d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

NextCure Provides Business Update and Reports Second Quarter 2022

Financial Results

–

On track to report data from all three clinical programs

–

Second quarter ending cash of $185.5 million expected to fund operations into the first quarter of 2024

BELTSVILLE, Md. – August 4, 2022 – NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today reported second quarter 2022 financial results and provided a business update.

“We have set the stage for multiple clinical data updates in the second half of this year for our NC318, NC410, and NC762 programs as well as an IND filing for NC525,” said Michael Richman, NextCure’s president and chief executive officer. “We expect our strong cash position of $185.5 million as of June 30, 2022 will fund our operations into the first quarter of 2024.”

Business Highlights

NC318

•

Announced the publication of a paper titled “Development of an Immunohistochemical Assay for Siglec-15” in Laboratory Investigation. The publication outlines data from a study, conducted in collaboration with researchers in the Department of Pathology at Yale School of Medicine, utilizing a newly developed antibody to Siglec-15 (S15) and an immunohistochemical (IHC) assay to investigate S15 expression in solid tumors.

NC410

•

Presented in vivo data at the 2022 Extracellular Matrix (ECM) Pharmacology Congress in Copenhagen that demonstrated NC410 remodels tumor ECM, enhances immune cell infiltration, alleviates immunosuppression, and reduces tumor growth in a humanized mouse tumor model.

•

Announced that collaborator Brahm Segal, M.D., of Roswell Park Comprehensive Cancer Center shared nonclinical data from a research study that models the ability of NC410 to block neutrophil-mediated suppression of T cells in a tumor microenvironment (TME) at the 24th Translational Research Cancer Centers Consortium Annual Meeting. In addition, NextCure appointed Dr. Segal to its Scientific Advisory Board (SAB).

Expected Upcoming Milestones

The company remains on track for the following 2022 milestones:

•

NC318 (S15 mAb) Phase 2 update: fourth quarter of 2022 (Amended Phase 2 with patient selection and increased dosing).

•

NC318 (S15 mAb) anti-PD-1 combo initial data: second half of 2022 (Yale University Investigator-Initiated trial).

•

NC410 (LAIR‐2 fusion) Phase 1 update: second half of 2022.

•

NC762 (B7‐H4 mAb) Phase 1 initial data: second half of 2022.

•

NC525 (LAIR‐1 mAb) Investigational New Drug (IND) Application filing: fourth quarter of 2022.

Financial Guidance

Based on its current research and development plans, NextCure expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditures into the first quarter of 2024.

Financial Results for Quarter Ended June 30, 2022

•

Cash, cash equivalents, and marketable securities, excluding restricted cash as of June 30, 2022, were $185.5 million as compared to $219.6 million as of December 31, 2021. The decrease of $34.1 million primarily related to cash used to fund operations, cash used to purchase fixed assets, and changes in the fair value of our marketable securities.

•

Research and development expenses were $12.8 million for the quarter ended June 30, 2022, as compared to $11.9 million for the quarter ended June 30, 2021. The increase of $0.9 million was driven primarily by additional clinical and lab-related costs.

•

General and administrative expenses were $5.3 million for the quarter ended June 30, 2022, as compared to $6.0 million for the quarter ended June 30, 2021. The decrease of $0.7 million was primarily related to reduced professional services and personnel-related costs.

•

Net loss was $17.9 million for the quarter ended June 30, 2022, as compared with a net loss of $18.0 million for the quarter ended June 30, 2021. The changes in net loss from the previous year’s quarter was primarily due to higher interest income and lower general administrative expenses offset by increased research and development expenses.

About NextCure, Inc.

NextCure is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases. Through our proprietary FIND-IO™ platform, we study various immune cells to discover and understand targets and structural components of immune cells and their functional impact in order to develop immunomedicines. Our initial focus is to bring hope and new treatments to patients who do not respond to current cancer therapies, patients whose cancer progresses despite treatment and patients with cancer types not adequately addressed by available therapies. 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 our plans, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans regarding our immunomedicines and upcoming milestones. 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: the impacts of the COVID-19 pandemic (including the emergence of variant strains) on NextCure’s business, including NextCure’s clinical trials, third parties on which NextCure relies and NextCure’s operations; positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and no products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need to obtain additional financing; risks related to clinical development, marketing approval and commercialization; the unproven approach to the discovery and development of product candidates based on NextCure’s FIND-IO platform; and 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 the Company’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.

NEXTCURE, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited, in thousands, except share and per share amounts)

Selected Financial Information

Selected Statement of Operations Items:		Three Months Ended								Six Months Ended
		June 30,								June 30,
(in thousands, except share and per share amounts)		2022				2021				2022				2021
Operating expenses:
Research and development		$	12,825			$	11,945			$	27,849			$	24,331
General and administrative			5,303				6,007				11,050				10,855
Loss from operations			(18,128	)			(17,952	)			(38,899	)			(35,186	)
Other income, net			208				(35	)			377				666
Net loss		$	(17,920	)		$	(17,987	)		$	(38,522	)		$	(34,520	)
Net loss per common share - basic and diluted		$	(0.65	)		$	(0.65	)		$	(1.39	)		$	(1.25	)
Weighted-average shares outstanding - basic and diluted			27,744,762				27,610,398				27,726,864				27,603,948

Selected Balance Sheet Items:

		June 30,				December 31,
(in thousands)		2022				2021
Cash, cash equivalents, and marketable securities		$	185,492			$	219,591
Total assets			206,370				242,386
Accounts payable and accrued expenses			5,597				6,391
Total stockholders' equity			198,196				233,386

Investor Inquiries

Timothy Mayer, Ph.D.

NextCure, Inc.

Chief Operating Officer

(240) 762-6486

IR@nextcure.com

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Cover	Aug. 04, 2022
Cover [Abstract]
Document Type	8-K
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Document Period End Date	Aug. 04, 2022
Entity File Number	001-38905
Entity Registrant Name	NextCure, Inc.
Entity Central Index Key	0001661059
Entity Tax Identification Number	47-5231247
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	9000 Virginia Manor Road
Entity Address, Address 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
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
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
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