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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 3, 2023

 

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 2.02.Results of Operations and Financial Condition.

On August 3, 2023, NextCure, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2023. 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 3, 2023

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: August 3, 2023

NEXTCURE, INC.

 

 

 

 

By:

/s/ Steven P. Cobourn

 

Name:

Steven P. Cobourn

 

Title:

Chief Financial Officer

Exhibit 99.1

Graphic

NextCure Provides Business Update and Reports Second Quarter 2023 Financial Results

Phase 1b data for NC410 and further updates on other clinical programs expected in the fourth quarter of 2023
Cash of approximately $131 million expected to fund operations into mid-2025

BELTSVILLE, Md. – August 3, 2023 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 provided a business update and reported second quarter 2023 financial results.

“As we enter the remainder of 2023, we continue generating important data and are nearing updates on our clinical programs expected in the fourth quarter of this year,” said Michael Richman, NextCure’s president and chief executive officer. “We expect to continue to advance our programs while prudently managing our resources to support our financial runway into mid-2025.”

Q2 2023 Business Highlights and Near-Term Milestones

NC410 (LAIR-2 fusion)

Continued enrollment in the Phase 1b/2 clinical trial evaluating NC410 in combination with pembrolizumab in patients with immune checkpoint naive or checkpoint refractory solid tumors.
Phase 1b data are expected in the fourth quarter of 2023.

NC762 (B7-H4 mAb)

Continued enrollment in the Phase 1b dose expansion study in patients with solid tumors and high expression of B7-H4.
Phase 1b update is expected in the fourth quarter of 2023.

NC525 (LAIR-1 mAb)

Continued enrollment in the Phase 1 monotherapy dose escalation and safety study evaluating NC525 in AML patients.
Phase 1a update is expected in the fourth quarter of 2023.


NC318 (Siglec-15)

Yale Cancer Center to present in September, “NC318, an Anti-Siglec-15 Humanized mAb, Alone and in Combination with Pembrolizumab in Immunotherapy Pretreated NSCLC”, at the International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer in Singapore.

Financial Guidance

NextCure expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditures into mid-2025.

Financial Results for Quarter Ended June 30, 2023

Cash, cash equivalents, and marketable securities as of June 30, 2023, were $130.6 million as compared to $159.9 million as of December 31, 2022. The decrease of $29.3 million was primarily related to cash used to fund operations, and cash used to purchase fixed assets.
Research and development expenses were $13.4 million for the quarter ended June 30, 2023, as compared to $12.8 million for the quarter ended June 30, 2022. The increase of $0.6 million was primarily related to higher clinical costs.
General and administrative expenses were $5.7 million for the quarter ended June 30, 2023, as compared to $5.3 million for the quarter ended June 30, 2022. The increase of $0.4 million was primarily related to higher payroll and legal costs partially offset by lower stock compensation costs and lower insurance costs.
Net loss was $17.9 million for the quarter ended June 30, 2023, as compared with a net loss of $17.9 million for the quarter ended June 30, 2022. Higher research and development expenses and higher general and administrative expenses were offset by higher other income, primarily interest income.

About NextCure, Inc.

NextCure is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines and other immune related-diseases to treat cancer. 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 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 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 immunomedicines. 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; the unproven approach to the discovery and development of product candidates based on NextCure’s FIND-IO platform; 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.

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)

2023

  

2022

  

2023

  

2022

Operating expenses:

Research and development

$

13,447

$

12,825

$

25,094

$

27,849

General and administrative

5,711

5,303

11,135

11,050

Loss from operations

 

(19,158)

 

(18,128)

 

(36,229)

 

(38,899)

Other income, net

 

1,299

 

208

 

2,274

 

377

Net loss

$

(17,859)

$

(17,920)

$

(33,955)

$

(38,522)

Net loss per common share - basic and diluted

$

(0.64)

$

(0.65)

$

(1.22)

$

(1.39)

Weighted-average shares outstanding - basic and diluted

 

27,828,741

 

27,744,762

 

27,801,788

 

27,726,864

Selected Balance Sheet Items:

June 30,

December 31,

(in thousands)

 

2023

   

2022

Cash, cash equivalents, and marketable securities

$

130,623

$

159,911

Total assets

$

153,380

$

184,161

Accounts payable and accrued liabilities

$

7,820

$

9,127

Total stockholders’ equity

$

138,430

$

167,530


Investor Inquiries

Timothy Mayer, Ph.D.

NextCure, Inc.

Chief Operating Officer

(240) 762-6486

[email protected]