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NextCure Provides Business Update and Reports Third Quarter 2025 Financial Results

Key Takeaway: NextCure, Inc. has provided a business update and reported its financial results for Q3 2025. The company is advancing its antibody-drug conjugate (ADC) programs, including the initiation of a Phase 1 trial for SIM0505 in the U.S. and receiving FDA clearance for LNCB74's protocol amendment. NextCure expects to share proof of concept data for both therapies in the first half of 2026.
Price reaction · baseline $9.63 (2025-11-05 close) · hit after-hours · clean, no other NXTC news in the window
day 0 close · peak
+2%

Market Sentiment Analysis

POSITIVE FACTORS

  • Significant progress in ADC programs.
  • U.S. enrollment in Phase 1 trial for SIM0505 has begun.
  • FDA clearance for higher dose escalation cohorts in LNCB74.

CONCERNS & RISKS

  • NextCure has a limited operating history.
  • No products approved for commercial sale yet.
  • Dependence on key personnel poses risks.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+66%
120-day peak, hindsight
Typical move
5.6%
average across 3 past catalysts
Cash runway
~6 mo
High dilution risk
Lead asset
NC318
Phase 2 · Advanced Non-small Cell Lung Cancer

Full Press Release Details

BELTSVILLE, Md., Nov. 05, 2025 (GLOBE NEWSWIRE) --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 provided a business update and reported third quarter 2025 financial results.
“We have made significant progress advancing our promising ADC programs,” said Michael Richman, NextCure’s president and CEO. “We recently began U.S. enrollment in the Phase 1 trial for SIM0505, our CDH6 ADC, initiating at a mid-tier dose range where multiple clinical responses were observed in China by our partner Simcere Zaiming. We expect to advance into higher-dose cohorts in the US shortly, as is currently occurring in China. We believe the ability to dose at levels that match or exceed competitor CDH6-targeting ADCs should demonstrate the promise of this program. We also received FDA clearance for our LNCB74 protocol amendment, giving us the ability to add higher dose escalation cohorts. We plan to provide proof of concept data readouts on SIM0505 and LNCB74 in the first half of 2026.”

Business Highlights and Near-Term Milestones

SIM0505 (CDH6 ADC)

LNCB74 (B7-H4 ADC)

Financial Results for Quarter Ended September 30, 2025

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 targeted therapies including antibody-drug conjugates. 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. Please visitwww.nextcure.comfor more information.

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; NextCure’s ability to maintain listing of its common stock on the Nasdaq Global Select Market; 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 Nine Months Ended
September 30, September 30
(in thousands, except share and per share amounts) 2025 2024 2025 2024
Operating expenses:
Research and development $ 6,136 $ 8,770 $ 38,123 $ 32,586
General and administrative 2,809 3,725 9,736 12,165
Restructuring and asset impairment 2,542
Loss from operations (8,945 ) (12,495 ) (47,859 ) (47,293 )
Other income, net 321 955 1,451 3,242
Net loss $ (8,624 ) $ (11,540 ) $ (46,408 ) $ (44,051 )
Net loss per common share - basic and diluted $ (3.22 ) $ (4.95 ) $ (18.84 ) $ (18.91 )
Weighted-average shares outstanding - basic and diluted 2,676,116 2,331,320 2,462,821 2,329,219
Selected Balance Sheet Items:
September 30, December 31,
(in thousands) 2025 2024
Cash, cash equivalents, and marketable securities $ 29,110 $ 68,621
Total assets $ 39,613 $ 80,860
Accounts payable and accrued liabilities $ 10,995 $ 9,574
Total stockholders' equity $ 23,646 $ 65,472

Investor InquiriesTimothy Mayer, Ph.D.NextCure, Inc.Chief Operating Officer(240) 762-6486IR@nextcure.com

Frequently Asked Questions

What is NextCure's recent business update about?

NextCure provided a business update and reported its Q3 2025 financial results, highlighting progress in ADC programs.

What trials has NextCure initiated recently?

NextCure has begun U.S. enrollment in the Phase 1 trial for SIM0505.

What FDA clearance did NextCure receive?

NextCure received FDA clearance for a protocol amendment for LNCB74, allowing higher dose escalation.

When will NextCure provide proof of concept data?

NextCure plans to provide proof of concept data for SIM0505 and LNCB74 in the first half of 2026.

Last updated: Nov 5, 2025