Item 2.02Results 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 7.01Regulation 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 8.01Other 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 first half of 2026. |
| ● | 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 to provide a trial progress update in the second half of 2026. |
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,”
