{"url_path":"/sec/nxtc/8-k/2026-06-01/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 ****Other Events**","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-01","source_url":"https://www.sec.gov/Archives/edgar/data/1661059/0001104659-26-068604-index.html","accession_number":"0001104659-26-068604","cik":"0001661059","ticker":"NXTC","issuer_name":"NextCure, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1661059/0001104659-26-068604-index.html","primary_entity_key":"0001661059","primary_entity_name":"NextCure, Inc."},"word_count":528,"has_tables":true,"body_markdown":"**Item 8.01****Other Events**\n\n​\n\nOn June 1, 2026, Company announced data from its Phase 1 dose escalation study (NCT06792552) evaluating SIM0505 in a multicenter, first in human global study in patients with advanced solid tumors. The reported data were from 59 cancer patients applying a data cutoff of April 07, 2026. Patients in the U.S. (n=25) and China (n=34) received SIM0505 at doses ranging from 1.6 mg/kg to 9.6 mg/kg and were enrolled without preselection for CDH6 expression.\n\n​\n\nSIM0505 efficacy data for gynecologic cancer patients (consisting of ovarian cancer patients and uterine serous carcinoma (“USC”) patients) in dose cohorts in the range of 4.8 – 8.0 mg/kg and who have had a minimum 12 weeks of follow-up as of the April 7, 2026 data cut off (n=20) are reported in the table below.  All percentages reflect objective response rate (“ORR”) as determined using best response according to RECIST v1.1 criteria.\n\n​\n\n​\n\n​\n\nPatient Group\n\nORR*\n\nAll gynecologic patients (n=20)\n\n55% (11/20)\n\n• Ovarian cancer (n=17)\n\n52.9% (9/17)\n\n• USC (n=3)\n\n66.7% (2/3)\n\n*Reported for patients within therapeutic SIM0505 dose cohorts of 4.8 - 8.0 mg/kg who had a minimum 12 weeks of follow-up at the April 7, 2026 data cut-off, and were determined by best response according to RECIST 1.1 criteria. Of the nine (9) ovarian patients with PR, there was one unconfirmed PR and one PR pending confirmation at next follow-up scan.\n\n​\n\nSIM0505 safety data for all patients (n=59) were as follows. No primary prophylaxis for hematological toxicities was used. The observed Grade 1 and Grade 2 treatment emergent adverse events (“TEAEs”) were predominantly hematological, nausea and vomiting. TEAEs leading to dose reduction (n=12) were predominantly hematological (4.8 – 9.6 mg/kg) and the majority occurring at 8.0 mg/kg, with nonhematological events including fatigue, dyspnoea, and nausea/vomiting (n=1 each). Observed Grade 3 and 4 TEAEs were predominantly hematological and manageable without primary prophylaxis for hematological toxicities. Treatment related adverse events (“TRAEs”) requiring dose discontinuation (n=3) were Grade 2 interstitial lung disease (“ILD”) and Grade 3 fungal pneumonia (both at 6.4 mg/kg), and Grade 4 thrombocytopenia (at 9.6 mg/kg). Adverse Events of Special Interest (“AESI”) were pneumonitis (n=1, Grade 1 at 5.6 mg/kg), and ILD (n=1, Grade 2 at 6.4 mg/kg).  \n\n​\n\n​\n\nPatient demographics data for all patients (n=59) were as reported in the table below:\n\n​\n\n​\n\n​\n\n​\n\n​\n\n​\n\nAll Patients\n\nBaseline Characteristics\n\n(n=59)\n\nAge, years: median (range)\n\n58 (42-78)\n\nSex, %: Male/Female\n\n3.4%/96.6%\n\nRace, n (%)\n\n​\n\nAsian\n\n34 (57.6%)\n\nBlack or African American\n\n3 (5.1%)\n\nWhite\n\n20 (33.9%)\n\nOther\n\n2 (3.4%)\n\nTumor Type, n (%)\n\n​\n\nOvarian\n\n46 (78.0%)\n\nUSC/other endometrial\n\n10 (16.9%)\n\nRenal cell carcinoma (RCC)\n\n3 (5.1%)\n\nECOG performance status, n (%)\n\n​\n\n0\n\n16 (27.1%)\n\n1\n\n43 (72.9%)\n\nPrior systemic anti-cancer regimen: median (range)\n\n5 (1-12)\n\n​\n\nOn June 1, 2026, Company announced that it believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into the first quarter of 2027. Company based this estimate on assumptions that may prove to be incorrect, and it could exhaust its available capital resources sooner than it currently expects.\n\n​\n\n​\n\n​"}