Item 7.01 Regulation FD Disclosure On June 1, 2026, NextCure, Inc. (“Company”) issued a press release announcing the presentation of a poster containing Phase 1 dose escalation data for its investigational drug candidate SIM0505, such presentation occurring at the American Society for Clinical Oncology 2026 conference (“ASCO 2026”) in Chicago, IL, on June 1, 2026.…
Filed Jun 1, 2026Accepted Jun 1, 2026, 8:10 AM EDTCIK 1661059Accession 0001104659-26-068604
NextCure is a biopharmaceutical company focused on managing its legacy clinical and intellectual property assets, pursuing opportunities to maximize those legacy assets, fulfilling ongoing obligations under its existing collaboration and licensing agreements and advancing completion of the Merger with Avere.
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Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01
Regulation FD Disclosure
On June 1, 2026, NextCure, Inc. (“Company”) issued a press release announcing the presentation of a poster containing Phase 1 dose escalation data for its investigational drug candidate SIM0505, such presentation occurring at the American Society for Clinical Oncology 2026 conference (“ASCO 2026”) in Chicago, IL, on June 1, 2026.
A copy of the Company press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K, and a copy of the ASCO 2026 poster is furnished as Exhibit 99.2 to this Current Report on Form 8-K.
On June 1, 2026, Company updated its corporate presentation to reflect pipeline updates and interim phase 1 data from its ongoing clinical trial for SIM0505. Beginning on June 1, 2026, Company will be engaging with members of the investment community, which may reference these presentation materials.
A copy of the Company presentation materials is furnished as Exhibit 99.3 to this Current Report on Form 8-K.
The information contained in this Item 7.01, including Exhibits 99.1, 99.2, and 99.3, 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, nor shall it be deemed incorporated by reference into any of the Company’s filings under the Exchange Act or the Securities Act, regardless of any general incorporation language in such filing.
Item 8.01Item 8.01 - Other Events
Item 8.01
Other Events
On 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.
SIM0505 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.
Patient Group ORR*
All gynecologic patients (n=20) 55% (11/20)
• Ovarian cancer (n=17) 52.9% (9/17)
• USC (n=3) 66.7% (2/3)
*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.
SIM0505 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).
Patient demographics data for all patients (n=59) were as reported in the table below:
All Patients
Baseline Characteristics (n=59)
Age, years: median (range) 58 (42-78)
Sex, %: Male/Female 3.4%/96.6%
Race, n (%)
Asian 34 (57.6%)
Black or African American 3 (5.1%)
White 20 (33.9%)
Other 2 (3.4%)
Tumor Type, n (%)
Ovarian 46 (78.0%)
USC/other endometrial 10 (16.9%)
Renal cell carcinoma (RCC) 3 (5.1%)
ECOG performance status, n (%)
0 16 (27.1%)
1 43 (72.9%)
Prior systemic anti-cancer regimen: median (range) 5 (1-12)
On 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.
Filed exhibits (2)
EX-99.1 (by filename) nxtc-20260601xex99d1.htm
EX-99.1
2
nxtc-20260601xex99d1.htm
EX-99.1
Exhibit 99.1
NextCure Presents Positive SIM0505 Phase 1 Dose Escalation Data in Patients with Gynecologic Cancers at ASCO 2026
55% ORR in gynecologic cancers with 52.9% in ovarian and 66.7% in USC at 12 weeks by best response per RECIST 1.1 within the therapeutic dose range (4.8 – 8.0 mg/kg)
Favorable safety and tolerability in heavily pretreated population supports ongoing Phase 1 dose-optimization with emphasis on PROC
NextCure to host virtual Key Opinion Leader (KOL) Event June 2, 2026 at 8 AM ET
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BELTSVILLE, MD - June 1, 2026 (GLOBE NEWSWIRE) - NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies to treat cancer, and Simcere Zaiming Pharmaceutical Co., Ltd., (Simcere Zaiming) an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced the presentation of positive Phase 1 dose escalation data for SIM0505 at the American Society for Clinical Oncology (ASCO 2026) in Chicago, IL (poster #246). SIM05…
Open exhibit ↗EX-99.2 (by filename) nxtc-20260601xex99d2.htm
EX-99.2
3
nxtc-20260601xex99d2.htm
EX-99.2
Exhibit 99.2
Cadherin 6 (CDH6) is a transmembrane glycoprotein overexpressed in multiple
cancers, including ovarian cancer (OC) and endometrial cancer (EC). SIM0505 is an
ADC comprised of an anti-CDH6 humanized IgG1 monoclonal antibody, a stable linker
cleaved within tumor cells, and a novel topoisomerase I inhibitor, CPT116. Here, we
report initial results from a global FIH study of SIM0505 (NCT06792552).
This is a Phase 1 study using a Bayesian Optimal
Interval (BOIN) dose escalation design to evaluate the
safety, tolerability, pharmacokinetics, and preliminary
anti-tumor activity of SIM0505 in patients (pts) with
advanced solid tumors regardless of CDH6
expression. SIM0505 was administered IV every 21
days.
As of 7 Apr 2026, 59 pts were enrolled without
preselection for CDH6 expression (46 OC, 10 EC, 3
renal cell cancer) in the dose-escalation (1.6 mg/kg to
9.6 mg/kg). The median duration of follow-up was 5.22
months (range 0.1-10.6)...
*9
Figure 1. Study Design (Dose Escalation)
Table 1. Study Patient Demographics Figure 2. TEAEs ≥10% Any Grade
Safety By Dose Levels
Abstract 5580: Phase …