Welcome to our dedicated page for Nextcure SEC filings (Ticker: NXTC), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
NextCure, Inc. filings document a clinical-stage oncology issuer's financial reporting, governance, capital structure, and material-event disclosures. Recent Form 8-K reports furnish quarterly and annual results, business update exhibits, Regulation FD materials on ADC programs, officer transition disclosure, a completed private placement of common stock and pre-funded warrants, and an effected reverse stock split.
The company's proxy materials cover annual meeting matters including director elections, auditor ratification, say-on-pay, board governance, and executive compensation for a Delaware corporation with Nasdaq-listed common stock.
NextCure, Inc. reported Phase 1 dose escalation data for its investigational ADC SIM0505 in advanced solid tumors, with a focus on gynecologic cancers. The study enrolled 59 heavily pre-treated patients in the U.S. and China at doses from 1.6 mg/kg to 9.6 mg/kg without CDH6 preselection.
Among 20 gynecologic cancer patients in therapeutic dose cohorts of 4.8–8.0 mg/kg with at least 12 weeks of follow-up, the objective response rate was 55% (11/20). Ovarian cancer patients (n=17) had a 52.9% ORR (9/17), and uterine serous carcinoma patients (n=3) had a 66.7% ORR (2/3), based on RECIST 1.1.
In 59 patients, treatment-emergent adverse events were mainly hematologic, nausea and vomiting; grade 3–4 events were predominantly hematologic and described as manageable without primary prophylaxis. Dose discontinuations were linked to interstitial lung disease, fungal pneumonia and thrombocytopenia at higher doses. NextCure stated that its existing cash, cash equivalents and marketable securities are expected to fund planned operations into the first quarter of 2027.
NextCure, Inc. reporting persons SilverArc Capital Management, LLC and Devesh Gandhi each disclose beneficial ownership of 176,057 shares of Class A Common Stock, representing 4.94% of the class. The filing shows shared voting and shared dispositive power over those shares. The filing is signed on 05/13/2026.
NextCure, Inc. reported a net loss of $9.8 million for the quarter ended March 31, 2026, modestly improved from $11.0 million a year earlier, as both research and development and general and administrative expenses declined.
Operating expenses fell to $10.1 million, driven by lower spending on deprioritized programs and reduced stock-based compensation, partly offset by new costs for SIM0505, an antibody-drug conjugate licensed in 2025. Other income decreased as interest earnings declined with a smaller cash balance.
Cash, cash equivalents and marketable securities totaled $29.7 million, and operating activities used $13.4 million of cash in the quarter. The company disclosed that this cash is not sufficient to fund operations for 12 months after issuance of the financial statements, raising substantial doubt about its ability to continue as a going concern unless additional capital is secured. NextCure continues Phase 1 trials for SIM0505 and LNCB74 and raised about $1.2 million through at-the-market stock sales during the quarter.
NextCure, Inc. reported first quarter 2026 results and highlighted pipeline progress. The FDA granted Fast Track designation to SIM0505 for platinum-resistant ovarian cancer, and initial Phase 1 dose escalation data are expected in Q2 2026, with a planned ASCO 2026 presentation.
Management is expanding SIM0505 development by increasing U.S. trial sites and moving into Canada and Europe, while Phase 1 enrollment continues for the LNCB74 B7-H4 antibody-drug conjugate. For the quarter ended March 31, 2026, research and development expense was $6.8M and general and administrative expense was $3.3M.
Net loss was $9.8M, or $1.87 per share, compared with a $11.0M loss, or $4.70 per share, a year earlier. Cash, cash equivalents and marketable securities totaled $29.7M as of March 31, 2026.
NextCure, Inc. Schedule 13G/A Amendment discloses that a group of related Simcere entities and two individuals report beneficial interests totaling 338,636 shares of NextCure common stock, representing 9.4% of the class, based on 3,607,555 shares outstanding as of April 22, 2026. The filing is a joint amendment by Simcere Zaiming, Inc.; Jiangsu Simcere Zaiming Pharmaceutical Co., Ltd.; Simcere Zaiming Pharmaceutical Co., Ltd.; Simcere Pharmaceutical Group Limited; and Messrs. Ren and Tang, and includes a standard disclaimer that each Reporting Person disclaims beneficial ownership except for pecuniary interest.
NextCure, Inc. is asking stockholders to vote at its virtual 2026 annual meeting on June 18, 2026 at 11:00 a.m. Eastern Time. Holders of 3,607,555 common shares as of April 22, 2026 can participate and vote online.
Stockholders are asked to elect two Class I directors, Anne Borgman, M.D., and John G. Houston, Ph.D., to terms ending in 2029, ratify Ernst & Young LLP as independent auditor for 2026, and approve an advisory “Say‑on‑Pay” vote on executive compensation. They are also asked to approve an amended and restated 2019 Omnibus Incentive Plan that increases shares of common stock authorized for equity awards.
The proxy highlights NextCure’s focus as a clinical‑stage cancer biotech developing antibody‑drug conjugates and other biologics, including SIM0505 and LNCB74, with Phase 1 data updates expected in 2026. It also details board structure, director pay, and 2025 compensation for key executives.
NextCure, Inc. is a clinical-stage biopharmaceutical company focused on antibody-drug conjugates to treat cancers that do not respond to current therapies. Its two lead candidates are SIM0505, a CDH6-targeted ADC licensed from Zaiming, and LNCB74, a B7-H4-targeted ADC co-developed with LigaChem.
SIM0505 and LNCB74 are both in Phase 1 trials, with early data updates planned in 2026. NextCure restructured operations in March 2024, pausing internal manufacturing and reducing its workforce to align with this focused pipeline. The company reported a net loss of $55.8 million in 2025, an accumulated deficit of $436.0 million, a non‑affiliate market value of about $12.6 million as of mid‑2025, and states it will need substantial additional capital. It holds an intellectual property portfolio expected to provide patent protection for LNCB74 and SIM0505 into 2039 and 2044, respectively.
NextCure reported full year 2025 results and highlighted progress on its antibody-drug conjugate pipeline. The company is preparing to present Phase 1 dose escalation data for SIM0505 in Q2 2026 and plans to begin enrolling platinum-resistant ovarian cancer patients into a Phase 1 dose optimization study, while doubling U.S. trial sites and expanding into additional countries.
For the year ended December 31, 2025, research and development expenses were 44,923 (in thousands) and general and administrative expenses were 12,693 (in thousands), with no restructuring and asset impairment charges compared to 2,542 (in thousands) in 2024. Net loss was 55,844 (in thousands), or 19.65 per basic and diluted share, versus 23.88 in 2024 (restated for a reverse stock split. Cash, cash equivalents, and marketable securities were 41,818 (in thousands) as of December 31, 2025, down from 68,621 (in thousands) a year earlier, and total stockholders’ equity declined to 34,943 (in thousands) from 65,472 (in thousands).
NextCure, Inc. major shareholder Sofinnova Venture Partners IX, L.P. filed Amendment No. 2 to its Schedule 13D reporting beneficial ownership of 222,654 shares of common stock, equal to 7.1% of the company. This percentage is based on 3,122,143 shares outstanding as of December 19, 2025.
The amendment explains that the ownership percentage declined by at least one percentage point due to dilution from NextCure’s additional sales of common stock reported in a recent prospectus supplement. Sofinnova, its general partner Sofinnova Management IX, L.L.C., and managing member Dr. James I. Healy hold the position for investment purposes and may buy, sell, or distribute shares over time depending on market conditions and their evaluation of NextCure, but report no transactions in the last 60 days.
Ikarian Capital, LLC and Neil Shahrestani reported beneficial ownership of 363,035 shares of NextCure, Inc. common stock, representing 9.99% of the class. The position is held through Ikarian Healthcare Master Fund, L.P. and certain separate managed accounts advised by Ikarian Capital.
The total includes 124,732 shares that may be acquired within 60 days via warrants, which are subject to a 9.99% beneficial ownership cap on exercise. The ownership is reported on a passive basis and the securities are stated as acquired and held in the ordinary course of business.