Results of Operations and Financial Condition · Regulation FD Disclosure · Other Events
Item 2.02 Results of Operations and Financial Condition On January 23, 2026, NextCure, Inc. (the “Company”) issued a press release announcing preliminary results that as of December 31, 2025, it had approximately $41.8 million in cash, cash equivalents and marketable securities.…
Filed Jan 23, 2026Accepted Jan 23, 2026, 7:20 AM ESTCIK 1661059Accession 0001104659-26-006021
NextCure is a biopharmaceutical company headquartered in Beltsville, Maryland. NextCure's retained clinical, regulatory, CMC, and finance personnel support the ongoing clinical development of LNCB74 under the Company's Transition and Continuation Agreement with LigaChem Biosciences, manage the transition of patients enrolled in the SIM0505 study, and conduct the Company's efforts to partner, license or otherwise monetize its legacy clinical and preclinical assets. NextCure has entered into a definitive merger agreement with Avere Therapeutics and, upon closing, the combined company is expected to operate as Avere Therapeutics and to be listed on Nasdaq under the ticker symbol “AVRX.”
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Item 2.02Item 2.02 - Results of Operations
Item 2.02
Results of Operations and Financial Condition
On January 23, 2026, NextCure, Inc. (the “Company”) issued a press release announcing preliminary results that as of December 31, 2025, it had approximately $41.8 million in cash, cash equivalents and marketable securities. The Company expects current financial resources to be sufficient to fund planned operating expenses and capital expenditures into the first half of 2027.
Because the Company’s consolidated financial statements for the year ended December 31, 2025 have not yet been finalized, the preliminary statement of the Company’s cash, cash equivalents and marketable securities as of December 31, 2025 in this Item 2.02 is unaudited and subject to adjustment.
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01
Regulation FD Disclosure
A copy of the press release referenced in Item 2.02 hereof is filed as Exhibit 99.1 to this Current Report on Form 8-K and is hereby incorporated by reference into this Item 7.01.
Additionally, on January 23, 2026, the Company updated its corporate presentation. A copy of the corporate presentation is attached hereto as Exhibit 99.2 and is hereby incorporated by reference into this Item 7.01.
Except to the extent described in Item 8.01 hereof, the information contained in this Item 7.01, including Exhibits 99.1 and 99.2, 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 8.01Item 8.01 - Other Events
Item 8.01
Other Events
The information in Item 2.02 hereof is incorporated by reference into this Item 8.01. Additionally, the press release referenced in Items 2.02 and 7.01 hereof included the following program updates for the Company’s two antibody drug conjugate (ADC) programs:
Data from the SIM0505 Phase 1 open-label dose escalation study are anticipated to be presented in the second quarter of 2026, including results from patients in the U.S. and China. The SIM0505 study (NCT06792552) is evaluating patients with advanced solid tumors with a focus on gynecological cancers and an emphasis on platinum resistant ovarian cancer. The Company is adding clinical sites and increasing SIM0505 clinical drug supply in anticipation of initiating dose optimization in the fi...
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Dosing of patients has commenced in higher dose cohorts for the ongoing open-label Phase 1 dose escalation LNCB74 study (NCT06774963) following the November 2025 protocol amendment announcement. Higher dose cohorts will prioritize patients with high B7-H4 expression in breast and gynecological cancers, while now including adenoid cystic carcinoma type 1. Proof-of-concept data, previously anticipated in the first half of 2026, is delayed to accommodate enrollment; the Company now expects t...
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Some of the statements contained in this Item 8.01 are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to statements related to our cash runway 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,” “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: market and other conditions, positive results in preclinical studies may not be predictive of the results of clinical trials; the Company’s limited operating history and not having any products approved for commercial sale; the Company’s history of significant losses; the Company’s need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization, including risks associated with reliance upon our collaborative partners and international vendors; the Company’s ability to maintain listing of its common stock on the Nasdaq Global Select Market; and the Company’s dependence on key personnel. More detailed information on these and additional factors that could affect the Company’s actual results are described under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, 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 the Company assumes no obligation to update any forward-looking statements, even if expectations change.
Filed exhibits (2)
EX-99.1 (by filename) nxtc-20260123xex99d1.htm
Exhibit 99.1
NextCure Provides Business Update
SIM0505 (CDH6 ADC) Phase 1 dose escalation data update anticipated in Q2 2026
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LNCB74 (B7-H4 ADC) Phase 1 dose escalation expanded into higher dose cohorts
BELTSVILLE, MD - January 23, 2026 (GLOBE NEWSWIRE) - NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to developing novel therapies to treat cancer, today provided updates for its two antibody drug conjugate (ADC) programs and reported a preliminary year-end 2025 cash position.
SIM0505 (CDH6 ADC): Phase 1 dose escalation data expected in Q2 2026
SIM0505 is a novel ADC directed to cadherin-6 (CDH6 ADC), which is overexpressed in several cancers with limited expression in healthy tissues. SIM0505 features a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window.
Data from the Phase 1 open-label dose escalation study are anticipated to be presented in the second quarter of 2026, including results from patients in the U.S. and China.
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Open exhibit ↗EX-99.2 (by filename) nxtc-20260123xex99d2.htm
Exhibit 99.2
NASDAQ: NXTC
SIM0505
LNCB74
J A N U A R Y 2 0 2 6
Corporate Presentation
Forward-Looking Statements
2
To the extent that statements contained in this presentation are not descriptions of historical facts, they may be deemed to be forward-looking
statements under the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations, forecasts, assumptions and
other information available to NextCure as of the date hereof. Forward-looking statements include statements regarding NextCure’s expectations,
beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as “may,” “will,” “potential,” “expects,”
“believes,” “intends,” “hope,” “towards,” “forward,” “later” and similar expressions. Examples of forward-looking statements in this presentation
include, among others, statements about our licensing agreement with Simcere Zaiming, statements about the development plans for our products,
statements about the progress and evaluation and expected timing of results of NextCure’s ongoing or planned clinical trials, expectations regarding
the potential benefits, acti…