Strong SIM0505 Phase 1 gynecologic cancer data for NextCure (Nasdaq: NXTC)
Rhea-AI Filing Summary
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.
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Insights
Early SIM0505 data show notable responses with manageable safety in heavily pre-treated gynecologic cancers.
NextCure released Phase 1 dose escalation data for SIM0505, an anti-CDH6 antibody-drug conjugate, in 59 patients with advanced solid tumors. In therapeutic dose cohorts of 4.8–8.0 mg/kg, gynecologic cancer patients showed double‑digit objective response rates under RECIST 1.1 criteria.
For gynecologic cancers overall, the objective response rate was 55% (11/20), including 52.9% (9/17) in ovarian cancer and 66.7% (2/3) in uterine serous carcinoma, all in heavily pre-treated populations. Safety findings were largely hematologic and characterized as manageable without primary prophylaxis, though some higher‑grade events led to dose reductions and discontinuations at higher doses.
The U.S. FDA has granted Fast Track Designation to SIM0505 for platinum-resistant ovarian cancer, which can facilitate future regulatory interactions. The company also indicated its cash, cash equivalents and marketable securities are expected to support planned operations into Q1 2027, providing a defined runway to advance the ongoing Phase 1 dose optimization segment and further data readouts.
8-K Event Classification
Key Figures
Key Terms
objective response rate medical
RECIST 1.1 medical
treatment emergent adverse events medical
antibody drug conjugate medical
Fast Track Designation regulatory
platinum-resistant ovarian cancer medical
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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Item 7.01Regulation 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 8.01Other 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.
Item 9.01Financial Statements and Exhibits
(d) Exhibits
Exhibit No. Description
99.1 Press Release issued by NextCure, Inc. dated June 1, 2026
99.2 ASCO 2026 Poster dated June 1, 2026
99.3 NextCure, Inc. Presentation dated June 1, 2026
104 Cover Page Interactive Data File (formatted as inline XBRL).
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: June 1, 2026 | NEXTCURE, INC. | |
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| By: | /s/ Steven P. Cobourn |
| Name: | Steven P. Cobourn |
| Title: | Chief Financial Officer |
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 |
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). SIM0505 is an investigational antibody drug conjugate (ADC) targeting Cadherin-6 (CDH6) with a proprietary topoisomerase 1 inhibitor (TOPOi) payload. NextCure plans to host a virtual KOL Event on Tuesday, June 2, 2026 (register here) to review these data.
Platinum-resistant ovarian cancer (PROC) and uterine serous carcinoma (USC) represent two of the most challenging gynecologic malignancies. In PROC, once platinum resistance develops, response rates to available therapies drop to as low as 10–25%, with a median overall survival of approximately 11 months. USC, while accounting for only 10% of uterine cancers, is responsible for about 40% of uterine cancer deaths, with 5-year survival falling to 33% in advanced-stage disease. Taken together, these two cancers represent a persistent and significant unmet need for more effective treatment options.1-3
The Phase 1 dose escalation study (NCT06792552) evaluated SIM0505 in 59 heavily pre-treated cancer patients, with 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, regardless of CDH6 expression.
Positive efficacy data were observed, with an objective response rate (ORR) of:
| ● | 55% (11/20) for gynecologic cancers (ovarian cancer and USC) |
| ● | 52.9% (9/17) for ovarian cancer |
| ● | 66.7% (2/3) for USC |
| ● | Responses were observed across a range of CDH6 expression |
ORRs, above, are reported for patients within therapeutic dose cohorts of 4.8 – 8.0 mg/kg who had a minimum 12 weeks of follow-up at the data cut-off, and were determined by best response according to RECIST 1.1 criteria. Of the nine (9) ovarian patients with partial response (PR), there was one unconfirmed PR and one PR pending confirmation at next follow-up scan.
“Positive Phase 1 data presented at ASCO 2026 validate our conviction in SIM0505 as a potential best-in-class CDH6-directed therapy for gynecologic cancers. Meaningful response rates at 12 weeks, alongside a manageable safety profile, give us strong confidence in this program and reinforce our enthusiasm for the ongoing dose optimization study. We believe SIM0505 has broad potential in gynecologic cancers and beyond, and these data put us on a solid track toward pivotal studies and our goal of bringing this treatment to patients," said Michael Richman, President and CEO of NextCure.
“Data presented at ASCO 2026 underscore the promise of our ADC platform and SIM0505, purpose-designed to deliver better efficacy, safety and tolerability, combining a carefully selected EC1 CDH6 epitope with our proprietary CPT116 topoisomerase payload. These results validate the science behind the SIM0505 construct and the accelerating pace of the global development program. Together with our partner, we remain deeply committed to advancing innovative medicines for patients facing hard-to-treat cancers,” said Renhong Tang, PhD, CEO of Simcere Zaiming.
“Treatment of gynecologic cancers has advanced meaningfully in recent years, yet the need for safer and more effective treatments remains real. CDH6 is an attractive target given its expression across ovarian, uterine, and other solid tumors. ADCs directed at this target have the potential to deliver the deeper, more durable responses these patients need. The early response rates observed for SIM0505 at ASCO 2026 are encouraging, and I believe the safety profile is manageable in routine clinical practice. I am enthusiastic about this program and its potential to advance the standard of care in gynecologic cancers,” said Udayan Guha, MD, PhD, Chief Medical Officer of NextCure.
ASCO Poster Overview: “Phase 1, multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 (CDH6) antibody-drug-conjugate (ADC) in patients with advanced solid tumors”
Table 1: Study Subject Overview:
| |
| 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) |
Table 2: Efficacy Overview:
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. | |
Overall safety: Favorable overall data, potentially manageable in routine practice setting (n=59):
| ● | Grade 1 and 2 treatment emergent adverse events (TEAEs) predominantly hematological, nausea and vomiting |
| ● | Grade 3 and 4 TEAEs predominantly hematological and manageable without primary prophylaxis for hematological toxicities |
| ● | Treatment related adverse events (TRAEs) requiring dose discontinuation: n=3 |
A full copy of the poster will be available on the NextCure website under the Investor Relations “Events & Presentations” tab following the presentation.
Virtual KOL Event
NextCure will host a virtual KOL Event to discuss the ASCO 2026 data.
| ● | Date: June 2, 2026 |
| ● | Time: 8:00 AM ET |
| ● | Registration Link: Click here |
A replay of the webinar will be accessible on the Events page of the NextCure website for 90 days.
About SIM0505
SIM0505 is a novel ADC directed to CDH6, featuring a proprietary TOPOi payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study (NCT06792552) for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on PROC. The U.S. Food and Drug Administration granted Fast Track Designation to SIM0505 for the treatment of PROC. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming.
About the Phase 1 Trial of SIM0505
SIM0505 is being evaluated in a global Phase 1 open-label, multicenter study (NCT06792552) with sites in the U.S. and China. The Phase 1 dose escalation segment has evaluated SIM0505, at dose levels from 1.6 mg/kg to 9.6 mg/kg, in heavily pre-treated cancer patients with solid tumors including gynecologic cancers and renal cell carcinoma. As of the April 7, 2026 data cutoff, 59 patients were enrolled without preselection for CDH6 expression. Follow-up is ongoing.
In May 2026, NextCure initiated a Phase 1 dose optimization segment in gynecologic cancers, initially focusing on patients with PROC. The global study is expected to enroll up to 120 patients, with initial doses of 5.6, 6.4 and 7.2 mg/kg, at sites in the U.S., Canada, the EU and China.
About Ovarian Cancer4-8
Ovarian cancer is the fifth leading cause of cancer-related death among women. It is characterized by vague, easily overlooked symptoms like bloating, pelvic pain, and frequent urination that often go undetected until late stage. Risk factors include age, family history, BRCA1/2 mutations, and hormone therapy use. The median age at diagnosis is 63, and the overall 5-year relative survival rate is 51.6% — though early-stage diagnosis carries a 5-year survival rate of 91.7%. As of 2022, an estimated 244,000 women were living with ovarian cancer in the United States.
About Uterine Serous Cancer2
Uterine serous carcinoma is a rare but highly aggressive subtype of endometrial cancer, accounting for approximately 10% of uterine cancers and about 40% of uterine cancer deaths. It typically arises in postmenopausal women, with abnormal or postmenopausal bleeding as the most common presenting symptom. Risk factors include advancing age, a history of breast cancer, tamoxifen use, and hereditary breast-ovarian cancer syndrome. More than half of patients present with stage III or IV disease at diagnosis, contributing to its disproportionate mortality burden.
About NextCure, Inc.
NextCure is a clinical-stage biopharmaceutical company focused on advancing innovative medicines to treat cancer patients through the use of targeted therapies including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells within and beyond the tumor microenvironment, and the role each interaction plays in a biologic response.
About Simcere Zaiming
Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, "Simcere"). Founded in 2023, Simcere Zaiming is dedicated to developing groundbreaking therapies to address the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including COSELA®, Enweida®, Endostar®, and Enlituo®. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners.
Sources:
| 1. | Based on Lheureux S, Braunstein M, Oza AM. CA Cancer J Clin. 2019;69(4):280–304. PMID: 31099893, DOI: 10.3322/caac.21559 |
| 2. | Based on Ferriss JS, Erickson BK, Shih IM, Fader AN. Int J Gynecol Cancer. 2021;31(8):1165–1174. PMID: 34210768, DOI: 10.1136/ijgc-2021-002753 |
| 3. | Based on Hamilton CA, Cheung MK, Osann K, et al. Br J Cancer. 2006;94(5):642–646. PMID: 16495918, DOI: 10.1038/sj.bjc.6603012 |
| 4. | Based on Cabarca S, Ili C, Vanegas C, Gil L, Vertel-Morrinson M, Brebi P. Drug resistance biomarkers in ovarian cancer: a bibliometric study from 2017 to 2022. Front Oncol. 2024 Nov 11;14:1450675. doi: 10.3389/fonc.2024.1450675. PMID: 39588300; PMCID: PMC11586235. |
| 5. | National Cancer Institute SEER Program |
| 6. | Ovarian Cancer Research Alliance (OCRA) |
| 7. | American Cancer Society |
| 8. | American Cancer Society / NCI SEER |
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Forward-Looking Statements
Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, our expected cash runway, objectives 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”, “towards”, “forward”, “later”, “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: our expectations regarding the timing, progress and results of preclinical studies and clinical trials for SIM0505, LNCB74 and any other product candidates we develop; our estimates regarding our expenses, future revenues, capital requirements, needs for or ability to obtain additional financing and the period over which we expect our current cash, cash equivalents and marketable securities to be sufficient to fund our operations, market and other conditions; the timing or likelihood of regulatory filings for SIM0505, LNCB74 and any other product candidates we develop and our ability to obtain and maintain regulatory approvals for such product candidates for any indication; the identification, analysis and use of biomarkers and biomarker data; our drug product sourcing and manufacturing strategy, including the scalability of our methods and processes; our expectations regarding the potential benefits, activity, effectiveness and safety of SIM0505, LNCB74 and any other product candidates we develop; our intentions and ability to successfully commercialize, including through partnering, our product candidates; our expectations regarding the nature of the biological pathways we are targeting; our expectations regarding our ability to discover and advance product candidates using our technologies; the potential benefits of and our ability to maintain our relationship with LigaChem Biosciences, Inc., Simcere Zaiming Pharmaceutical Co., Ltd., and other third-party vendors and collaborators; our ability to retain key personnel; our intended reliance on and the performance of third parties, including collaborators, contract research organizations and third-party manufacturers; changes in international relations, tariffs, and other trade regulations between the U.S. and China; our ability to protect and enforce our intellectual property protection and the scope and duration of such protection; developments and
projections relating to our competitors and our industry, including competing therapies; and the impact of current and future laws and regulations.
More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and 10-Q and in NextCure’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 NextCure assumes no obligation to update any forward-looking statements, even if expectations change.
Investor Inquiries
Timothy Mayer, PhD
NextCure, Inc.
Chief Operating Officer
(240) 762-6486
IR@nextcure.com
Mike Moyer
Managing Director,
LifeSci Advisors, LLC
Phone: (617) 308-4306
mmoyer@lifesciadvisors.com
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 I, Multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 antibody-drug-conjugate (ADC) in patients with advanced solid tumors. • TEAEs leading to Dose Reduced (n=12): Predominantly hematological (4.8 – 9.6mg/kg), with majority at 8.0mg/kg. Non-hematological events: fatigue, dyspnoea, and nausea/vomiting (n=1 each) • TRAEs leading to Dose Discontinued (n=3): Grade (Gr) 2 Interstitial Lung Disease (ILD) and Gr3 fungal pneumonia at 6.4mg/kg, Gr4 thrombocytopenia at 9.6mg/kg • Adverse Events of Special Interest (AESI): Pneumonitis (n=1, Gr 1 at 5.6mg/kg), ILD (n=1, Gr 2 at 6.4mg/kg) • No primary prophylaxis for hematological toxicities used Methods Demographics Safety Summary Results • SIM0505 demonstrated manageable safety and tolerability profile, including at higher dose levels, and showed encouraging antitumor efficacy in OC and USC, supported by a favorable PK profile • In patients with gynecological cancers (OC, USC, other endometrial) treated at 4.8 – 8.0mg/kg with at least 12 weeks of follow up ORR was 55% using best response (11/20 PR, 1 unconfirmed, 1 pending follow up) • Data supports Part 2 dose optimization in PROC at 5.6, 6.4, and 7.2mg/kg, currently underway Research Sponsors: Shanghai Simcere Zaiming Biotechnology Co., Ltd. (China) and NextCure, Inc. (US). The authors thank the patients, investigators, and site staff for their participation in this study. Conclusion Acknowledgements TEAE: Treatment-emergent adverse event, TRAE: Treatment-related adverse event 1 DLT: 9.6mg/kg- Gr 4 thrombocytopenia, Gr 4 febrile neutropenia and Gr 3 Gastrointestinal (GI) hemorrhage in same patient), 8.0mg/kg- Gr 3 febrile neutropenia, 7.2mg/kg-Gr 2 febrile neutropenia; * Gr 5: Dyspnoea from disease progression # Gr 5 Urinary tract infection; both unrelated to SIM0505 • SIM0505 (ADC) / Total Antibody (TAb) exposures had similar and dose proportional increase • No to minimal accumulation of SIM0505 (Rac AUC ~1.3- 1.8) or CPT116 (Rac AUC ~ 0.4-1.3) • Half life of SIM0505: ~6.6-9.5 days and CPT116: ~4.1-6.0 days Figure 3. Pharmacokinetic (PK) Profile of SIM0505 SIM0505 / TAb CPT116 Table 3. Grade ≥ 3* TEAEs Occurring in ≥ 5% of Patients Table 2. Overall Safety Summary Biomarkers and Pharmacokinetic Profile Background Preliminary Efficacy Figure 7. Decrease in Target Lesions Change from Baseline between 4.8 – 8.0 mg/kg Ovarian Cancer Uterine Serous Carcinoma *9 prior treatment regimens including Elahere * Figure 4. Best % Change in Target Lesion by CDH6 Membrane H-Score (N=35) All Tumor Types, All Doses • Reduction of tumor lesion was observed across a range of membrane CDH6 expression *Gr 3-4 only Overview of Adverse Events 1.6 mg/kg (n = 3) n (%) 3.2 mg/kg (n = 7) n (%) 4.8 mg/kg (n = 6) n (%) 5.6 mg/kg (n = 6) n (%) 6.4 mg/kg (n = 13) n (%) 7.2 mg/kg (n = 10) n (%) 8.0 mg/kg (n = 10) n (%) 9.6 mg/kg (n = 4) n (%) Total (n = 59) n (%) Treatment-emergent adverse events (TEAEs) (%) 3 (100.0) 7 (100.0) 6 (100.0) 6 (100.0) 13 (100.0) 10 (100.0) 10 (100.0) 4 (100.0) 59 (100) ≥Grade 3 TEAEs (%) 1 (33.3) 1 (14.3) 5 (83.3) 1 (16.7) 6 (46.2) 6 (60.0) 9 (90.0) 3 (75.0) 32 (54.2) TEAEs related to study drug (TRAEs) (%) 3 (100.0) 7 (100.0) 6 (100.0) 6 (100.0) 12 (92.3) 9 (90.0) 10 (100.0) 4 (100.0) 57 (96.6) ≥Grade 3 TRAEs (%) 0 0 4 (66.7) 1 (16.7) 6 (46.2) 5 (50.0) 9 (90.0) 3 (75.0) 28 (47.5) Serious adverse events (SAEs) (%) 1 (33.3) 1 (14.3) 1 (16.7) 0 3 (23.1) 3 (30.0) 5 (50.0) 2 (50.0) 16 (27.1) SAEs related to study drug (%) 0 0 0 0 3 (23.1) 2 (20.0) 3 (30.0) 2 (50.0) 10 (16.9) TEAEs leading to dose interruption (%) 1 (33.3) 0 4 (66.7) 0 6 (46.2) 1 (10.0) 5 (50.0) 3 (75.0) 20 (33.9) TRAEs leading to dose interruption (%) 0 0 3 (50.0) 0 3 (23.1) 0 5 (50.0) 3 (75.0) 14 (23.7) TEAEs leading to dose reduced (%) 0 0 2 (33.3) 0 2 (15.4) 1 (10.0) 6 (60.0) 1 (25.0) 12 (20.3) TRAEs leading to dose reduced (%) 0 0 2 (33.3) 0 2 (15.4) 1 (10.0) 5 (50.0) 1 (25.0) 11 (18.6) TEAEs leading to dose discontinued (%) 0 0 0 0 2 (15.4) 1 (10.0) 0 1 (25.0) 4 (6.8) TRAEs leading to dose discontinued (%) 0 0 0 0 2 (15.4) 0 0 1 (25.0) 3 (5.1) TEAEs leading to death (%) 0 0 0 0 0 1 (10.0)* 1 (10.0) # 0 2 (3.4) Adverse Event of Special Interest (AESI) 1 0 0 0 1 (16.7) 1 (7.7) 0 0 0 2 (3.4) Dose limiting toxicity (DLT) (%) 2 0 0 0 0 0 1 (10.0) 1 (10.0) 1 (25.0) 3 (5.1) Prior Regimens of therapy Median (Range) 6 (2-10) 4 (3-11) 4 (1-9) 6.5 (5-11) 4 (1-10) 4.5 (2-12) 4.5 (2-7) 6 (5-8) 5 (1-12) Baseline Characteristic All Patients (n = 59) Age, years Median (range) 58 (42-78) Sex, n (%) Male 2 (3.4%) Female 57 (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%) Uterine Serous Carcinoma/Other Endometrial 10 (16.9%) Renal Cell Carcinoma 3 (5.1%) ECOG performance status, n (%) 0 16 (27.1%) 1 43 (72.9%) Prior systemic anti-cancer regimens Median (range) 5 (1-12) Prior Therapies in Ovarian Cancer, n (%) Prior Exposure to Bevacizumab 36 (78.3%) Prior Exposure to PARP 30 (65.2%) Prior Exposure to Mirvetuximab soravtansine 11 (23.9%) FIGO stage (for gynecologic cancers), n (%) Stage II 2 (3.6%) Stage III 12 (21.8%) Stage IV 42 (75.0%) Overview of Adverse Events 1.6 mg/kg (n = 3) n (%) 3.2 mg/kg (n = 7) n (%) 4.8 mg/kg (n = 6) n (%) 5.6 mg/kg (n = 6) n (%) 6.4 mg/kg (n = 13) n (%) 7.2 mg/kg (n = 10) n (%) 8.0 mg/kg (n = 10) n (%) 9.6 mg/kg (n = 4) n (%) Total (n = 59) n (%) With at least one ≥G3 TEAE 1 (33.3) 1 (14.3) 5 (83.3) 1 (16.7) 6 (46.2) 6 (60.0) 9 (90.0) 3 (75.0) 32 (54.2) Platelet count decreased 0 0 3 (50.0) 0 4 (30.8) 0 5 (50.0) 2 (50.0) 14 (23.7) Neutrophil count decreased 0 0 1 (16.7) 0 2 (15.4) 3 (30.0) 6 (60.0) 2 (50.0) 14 (23.7) White blood cell count decreased 0 0 3 (50.0) 0 1 (7.7) 0 3 (30.0) 3 (75.0) 10 (16.9) Anemia 0 0 0 0 2 (15.4) 0 3 (30.0) 3 (75.0) 8 (13.6) Hypokalemia 0 0 0 0 1 (7.7) 1 (10.0) 2 (20.0) 0 4 (6.8) Gamma-glutamyltransferase increased 0 0 1 (16.7) 0 2 (15.4) 0 0 0 3 (5.1) Febrile neutropenia 0 0 0 0 0 1 (10.0) 1 (10.0) 1 (25.0) 3 (5.1) Lymphocyte count decreased 0 0 0 1 (16.7) 2 (15.4) 0 0 0 3 (5.1) Figure 6. Best Overall Response • Two intermediate dose levels (5.6 and 7.2 mg/kg) were initiated after evaluation of the highest dose level (9.6 mg/kg). • Median duration of follow-up was 1.51 months (range 1.1- 2.8) for 5.6 mg/kg and 1.18 months (range 0.3 -2.8) for 7.2 mg/kg. • At data cutoff, median DoR was not estimatable – NE (2.46, NE); follow-up is ongoing. All Patients, All Doses Figure 5. Treatment Duration and Response All Patients, All Doses #R- Number of prior regimens ORR**: 52.9% (9/17) ORR**: 66.7% (2/3) **ORR based on at least 12 weeks of follow-up and best response (confirmed and unconfirmed) |
Exhibit 99.3
| Corporate Presentation J U N E 2026 N A S D A Q : N X T C |
| 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, activity, effectiveness and safety of our research stage, preclinical stage, and clinical stage therapeutic candidates, NextCure’s financial guidance, expected upcoming milestones, and NextCure’s plans, objectives and intentions with respect to the discovery and development of therapeutic products. 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: positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and no products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need to obtain additional financing; risks related to clinical development, marketing approval and commercialization; the unproven approach to the discovery and development of product candidates based on NextCure’s discovery platform; and dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described in NextCure’s filings with the Securities and Exchange Commission (the “SEC”), including in Item 1A of NextCure’s most recent Form 10-K, subsequent Forms 10-Q and elsewhere in the Company’s filings with the SEC. 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 NextCure assumes no obligation to update any forward-looking statements, except as required by law, even if expectations change. |
| 3 In the Fight Against Cancer Harnessing the Power of Targeted Therapy 3 |
| ADC Pipeline Progress 4 PROGRAMS TARGET PAYLOAD PRECLINICAL PHASE 1 PHASE 2 NEXT MILESTONE SIM0505 CDH6 TOPO 1Q 2027 Dose Optimization Update 4Q 2026 Initiate Dose Optimization LNCB74 B7-H4 MMAE 2H 2026 Trial Progress Co-development with Breast, Ovarian, Endometrial , ACC-1 Ovarian Cancer Uterine Serous Carcinoma (USC) |
| 5 Accelerating Toward Pivotal Study ✓ Global exclusive license (ex China) from Simcere Zaiming ✓ Combine US and China data for fast & definitive POC ✓ US, China, Canada and Europe site expansion ✓ CDMO tech transfer initiated PRODUCT DEVELOPMENT SIM0505 ✓ 55% ORR in gynecologic cancers ✓ Completed dose escalation ✓ Initiated dose optimization ✓ Fast track granted for PROC CDH6 ADC |
| SIM0505 is a Differentiated CDH6 TOPOi ADC 6 Payload CPT116 (TOPO) GGFG Linker CDH6 mAb DAR 8.0 Cysteine conjugation Gly-Gly-Phe-Gly Provides Tumor-Specific Cleavage Unique Binding Epitope with Increased Affinity High Systemic Clearance for Reduced Toxicity Linker Potent Cytotoxicity with Anticipated Safety Improvement VALIDATED TARGET WITH PROPRIETARY TOPOi PAYLOAD |
| SIM0505 Structural and Functional Differentiation by Design • Unique distal EC1 epitope on CDH6 • Ovarian, uterine, RCC, NSCLC • High affinity & internalization • PK proportionality 7 Membrane EC1 EC2 EC3 EC4 EC5 SIM0505 •Designed for better tolerability & safety •Hydrophilic & high systemic clearance •Good permeability & bystander effect •Less aggregation than hydrophobic Hydrophilic vs Hydrophobic SIM0505 CPT116 (PAYLOAD) |
| •ORR (RECIST 1.1) •PFS SIM0505 Development Plan 8 9.6 mg/kg (n = 4) COMPLETED DOSE ESCALATION 2Q 2026 INITIATED DOSE OPTIMIZATION 2Q 2026 PLANNING PIVOTAL TRIAL •Generating recommended pivotal trial dose *TPC: treatment of physician’s choice PROC & USC PROC Q3W 8.0 mg/kg (n = 10) 6.4 mg/kg (n = 13) 4.8 mg/kg (n = 6) 3.2 mg/kg (n = 7) 1.6 mg/kg (n = 3) n = 59 (US = 25 & China = 34) Up to n = 120 Up to n = 430 7.2 mg/kg (n = 20-40) 6.4 mg/kg (n = 20-40) R 1:1 SIM0505 (n = 215) TPC* (n = 215) Dose Escalation Intermediate Doses + 7.2 mg/kg (n = 10) 5.6 mg/kg (n = 6) 5.6 mg/kg (n = 20-40) Q3W Q3W Ovarian, USC, RCC, EC |
| SIM0505 Patient Demographics Baseline Characteristic US Patients (n = 25) China Patients (n = 34) All Patients (n = 59) Age, years Median (range) 63 (49-78) 56 (42-72) 58 (42-78) Sex, n (%) Male 0 (0.0) 2 (5.9) 2 (3.4) Female 25 (100) 32 (94.1) 57 (96.6) Tumor Type, n (%) Ovarian 19 (76.0) 27 (79.4) 46 (78.0) USC/other endometrial 6 (24.0) 4 (11.8) 10 (16.9) RCC 0 (0.0) 3 (8.8) 3 (5.1) ECOG performance status, n (%) 0 8 (32.0) 8 (23.5) 16 (27.1) 1 17 (68.0) 26 (76.5) 43 (72.9) Prior systemic anti-cancer regimens Median (range) 3 (1-9) 5 (1-12) 5 (1-12) 9 Data cut 07Apr26 Patient Population • Poor performance status ̶~73% ECOG 1 • Heavily pretreated • ~75% of ovarian / USC patients had FIGO Stage IV metastatic tumor burden FIGO: International Federation of Gynecology and Obstetrics |
| 10 SIM0505 Has Shown a Well Manageable Safety Profile Overview of Adverse Events 1.6 – 9.6 mg/kg (n = 59) n (%) Treatment-emergent adverse events (TEAEs) (%) 59 (100) Grade ≥3 32 (54.2) Grade 5 a 2 (3.4) TEAEs related to study drug (TRAEs) (%) 57 (96.6) Grade ≥3 28 (47.5) Grade 5 0 Any Serious adverse events (SAEs) (%) 16 (27.1) Treatment related SAE, n (%) 10 (16.9) TRAE Dose modifications, n (%) Dose interruption 14 (23.7) Dose reduced 11 (18.6) Dose discontinued 3 (5.1) Interstitial Lung Disease (ILD) / Pneumonitis b 2 (3.3) Grade ≥3 0 (0) a. 1 Gr5 at 7.2 mg/kg related to disease progression, 1 Gr5 at 8.0 mg/kg complicated UTI (not related) b. 1 Gr1 ILD at 5.6mg/kg and 1 Gr2 ILD at 6.4mg/kg Data cut 07Apr26 |
| 0 10 20 30 40 50 60 70 Alopecia Asthenia Dyspnoea Hypomagnesaemia Blood bilirubin increased Lymphocyte count decreased Abdominal distension Amylase increased Gamma-glutamyltransferase increased Proteinuria Pyrexia Dizziness Hypertriglyceridaemia Weight decreased Hypoalbuminaemia Alanine aminotransferase increased Constipation Decreased appetite Fatigue Aspartate aminotransferase increased Hyponatraemia Hypokalaemia Nausea White blood cell count decreased Neutrophil count decreased Vomiting Platelet count decreased Anemia 10.2 10.2 10.2 10.2 13.6 13.6 15.3 15.3 15.3 15.3 15.3 16.9 16.9 16.9 22.0 23.7 25.4 28.8 28.8 33.9 35.6 37.3 47.5 47.4 50.8 50.9 52.5 62.8 0.0 0.0 3.4 0.0 0.0 5.1 1.7 0.0 5.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3.4 0.0 1.7 6.8 1.7 16.9 23.7 1.7 23.7 13.6 Patients, % Grade 3/4 Any Grade 11 n = 59 (AE’s shown as % of total) Most Common TEAEs (≥10%) •MTD not reached •No primary prophylaxis required for neutropenia & thrombocytopenia •Grades 1 & 2 TEAEs were predominantly hematological, nausea & vomiting •Grades 3 & 4 TEAEs were hematological and manageable |
| 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 5101016 - HGSOC - 7R 5103005 - HGSOC - 6R 5105006 - HGSOC - 5R 5102008 - RCC - 5R 5104004 - HGSOC - 4R 5208001 - HGSOC - 1R 5105004 - HGSOC - 3R 5203004 - HGSOC - 3R 5206001 - HGSOC - 5R 5103004 - HGSOC - 4R 5201002 - HGEOC - 3R 5203001 - USC - 4R 5103003 - HGSOC - 3R 5105003 - HGSOC - 2R 5205007 - HGSOC - 2R 5103006 - HGSOC - 4R 5206005 - HGSOC - 2R 5201004 - HGSOC - 6R 5205004 - HGEOC - 5R 5207001 - HGSOC - 4R 5201006 - USC - 3R 5201005 - USC- 2R 5206002 - HGSOC - 2R 5206003 - USC - 3R 5204004 - HGSOC - 2R 5205006 - USC - 2R 5205005 - HGSOC - 2R 5103001 - HGSOC - 3R 5202002 - HGSOC - 4R 5101014 - HGSOC - 7R 5104006 - HGSOC - 7R 5204001 - HGSOC - 3R 5104007 - HGSOC - 2R 5202001 - HGSOC - 9R 5105001 - HGSOC - 2R 5201001 - USC - 1R 5102006 - HGSOC - 5R 5101020 - HGSOC - 7R 5208002 - HGSOC - 6R 5205003 - HGSOC - 6R 5205001 - HGSOC - 9R 5206004 - HGSOC - 5R 5102009 - HGSOC - 5R 5101010 - HGSOC - 4R 5102005 - RCC - 1R 5101009 - LGSOC - 2R 5101011 - HGSOC - 3R 5105005 - HGSOC - 9R 5102003 - RCC - 2R 5104002 - HGSOC - 4R 5102002 - EC - 11R 5101007 - EC - 4R 5103002 - HGSOC - 6R 5101006 - USC - 4R 5104003 - HGSOC - 3R 5101005 - HGSOC -12R 5101003 - HGSOC - 6R 5101001 - HGSOC - 10R 5101002 - USC - 2R Swimmer Plot All Patients at All Doses 12 EC: endometrial cancer; HGSOC: high-grade serous ovarian cancer; HGEOC: high-grade endometroid cancer; LGSOC: low-grade serous ovarian cancer; RCC: renal cell carcinoma; USC: uterine serous carcinoma •6 dose cohorts + 2 intermediate dose cohorts •Prior systemic anti-cancer regimens: Median 5 (1-12) Weeks on Treatment On treatment Bold – US patients PATIENTS ENROLLED Total TOTAL 59 Ovarian Cancer 46 Uterine Serous Carcinoma (USC) 8 Renal Cell Carcinoma (RCC) 3 Dose Levels Other Endometrial Cancer 2 1.6 mg/kg 3.2 mg/kg 4.8 mg/kg 5.6 mg/kg 6.4 mg/kg 7.2 mg/kg 8.0 mg/kg 9.6 mg/kg cPR uPR SD RECIST PD cPR: confirmed partial response; uPR: unconfirmed partial response Data cut 07Apr26 |
| ORR at 4.8 – 8.0 mg/kg: ≥12 Weeks and Best Response 13 Tumor type Evaluable (n) PRs (n) ORR Gynecologic Cancers (OC + USC) 20 11 55.0% (11/20) Ovarian Cancer (OC) 17 9 52.9% (9/17) Uterine Serous Carcinoma (USC) 3 2 66.7% (2/3) |
| 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 5104004 - HGSOC - 4R 5208001 - HGSOC - 1R 5105004 - HGSOC - 3R 5203004 - HGSOC - 3R 5206001 - HGSOC - 5R 5103004 - HGSOC - 4R 5201002 - HGEOC - 3R 5203001 - USC - 4R 5103003 - HGSOC - 3R 5105003 - HGSOC - 2R 5205007 - HGSOC - 2R 5103006 - HGSOC - 4R 5206005 - HGSOC - 2R 5201004 - HGSOC - 6R 5205004 - HGEOC - 5R 5207001 - HGSOC - 4R 5201006 - USC - 3R 5201005 - USC- 2R 5206002 - HGSOC - 2R 5206003 - USC - 3R 5204004 - HGSOC - 2R 5205006 - USC - 2R 5205005 - HGSOC - 2R 5103001 - HGSOC - 3R 5202002 - HGSOC - 4R 5101014 - HGSOC - 7R 5104006 - HGSOC - 7R 5204001 - HGSOC - 3R 5104007 - HGSOC - 2R 5202001 - HGSOC - 9R 5105001 - HGSOC - 2R 5201001 - USC - 1R 5102006 - HGSOC - 5R 5101020 - HGSOC - 7R 5208002 - HGSOC - 6R 5205003 - HGSOC - 6R 5205001 - HGSOC - 9R 5206004 - HGSOC - 5R 5102009 - HGSOC - 5R 5101010 - HGSOC - 4R 5101009 - LGSOC - 2R 5101011 - HGSOC - 3R 5105005 - HGSOC - 9R Gynecologic Cancers at Therapeutic Doses ( 14 4.8 – 8.0 mg/kg) HGSOC: high-grade serous ovarian cancer; HGEOC: high-grade endometroid cancer; LGSOC: low-grade serous ovarian cancer; USC: uterine serous carcinoma Weeks on Treatment • n = 43 enrolled • Gynecologic cancers include ovarian and USC • Patients with at least ≥12 weeks follow-up • PRs demonstrate durability • 4 of 11 PRs from US • Other: ̶ 1 PR (USC) 1.6 mg/kg ̶ 1 PR (ovarian) 9.6 mg/kg ̶ 1 PR (USC) 7.2 mg/kg (has not reached 12 weeks) On treatment Evaluable PR ORR n = 20 11 55.0% Dose Levels 4.8 mg/kg 5.6 mg/kg 6.4 mg/kg 7.2 mg/kg 8.0 mg/kg cPR uPR SD RECIST PD cPR: confirmed partial response; uPR: unconfirmed partial response Data cut 07Apr26 |
| • n = 37 ovarian cancer patients • Patients with at least ≥12 weeks follow-up • Other: 1 PR 9.6 mg/kg Ovarian Cancer at Therapeutics Doses (4.8 – 8.0 mg/kg) 15 Weeks on Treatment HGSOC: high-grade serous ovarian cancer; HGEOC: high-grade endometroid cancer; LGSOC: low-grade serous ovarian cancer On treatment 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 5104004 - HGSOC - 4R 5208001 - HGSOC - 1R 5105004 - HGSOC - 3R 5203004 - HGSOC - 3R 5206001 - HGSOC - 5R 5103004 - HGSOC - 4R 5201002 - HGEOC - 3R 5103003 - HGSOC - 3R 5105003 - HGSOC - 2R 5205007 - HGSOC - 2R 5103006 - HGSOC - 4R 5206005 - HGSOC - 2R 5201004 - HGSOC - 6R 5205004 - HGEOC - 5R 5207001 - HGSOC - 4R 5206002 - HGSOC - 2R 5204004 - HGSOC - 2R 5205005 - HGSOC - 2R 5103001 - HGSOC - 3R 5202002 - HGSOC - 4R 5101014 - HGSOC - 7R 5104006 - HGSOC - 7R 5204001 - HGSOC - 3R 5104007 - HGSOC - 2R 5202001 - HGSOC - 9R 5105001 - HGSOC - 2R 5102006 - HGSOC - 5R 5101020 - HGSOC - 7R 5208002 - HGSOC - 6R 5205003 - HGSOC - 6R 5205001 - HGSOC - 9R 5206004 - HGSOC - 5R 5102009 - HGSOC - 5R 5101010 - HGSOC - 4R 5101009 - LGSOC - 2R 5101011 - HGSOC - 3R 5105005 - HGSOC - 9R Evaluable PR ORR n = 17 9 52.9% Dose Levels 4.8 mg/kg 5.6 mg/kg 6.4 mg/kg 7.2 mg/kg 8.0 mg/kg cPR uPR SD RECIST PD cPR: confirmed partial response; uPR: unconfirmed partial response Data cut 07Apr26 |
| 17.4 2.6 0.0 -9.1 -14.0 -14.9 -15.0 -27.2 -34.0 -41.6 -47.1 -50.2 -52.2 -53.7 -62.0 -68.4 -70.0 -75 -60 -45 -30 -15 0 15 30 5103004 / HGSOC / 5R 5204001 / HGSOC-FT / 3R 5201002 / HGEOC / 4R 5203004 / HGSOC / 4R 5104007 / HGSOC / 4R 5102009 / HGSOC / 5R 5101009 / LGSOC / 3R 5104006 / HGSOC / 10R 5103003 / HGSOC / 3R 5206001 / HGSOC / 4R 5105005 / HGSOC / 9R 5105003 / HGSOC / 4R 5101011 / HGSOC / 5R 5105004 / HGSOC / 5R 5202001 / HGSOC / 9R 5102006 / HGSOC / 6R 5105001 / HGSOC / 3R Ovarian Cancer (4.8 – 8.0 mg/kg) 16 •Defined therapeutic range •Greatest tumor shrinkage at 6.4 & 8.0 mg/kg •Up to 70% tumor shrinkage On treatment Tumor Percent Change from Baseline 4.8 mg/kg 5.6 mg/kg 6.4 mg/kg 8.0 mg/kg Dose Levels Data cut 07Apr26 |
| 0 6 12 18 24 30 36 -75 -60 -45 -30 -15 0 15 30 45 Weeks on Treatment Ovarian Cancer (4.8 – 8.0 mg/kg) 17 • Most patients (15/17) had tumor shrinkage • Increasing tumor shrinkage with continued treatment • The greatest tumor shrinkage and durability occurred at 6.4mg/kg Tumor Percent Change from Baseline Data cut 07Apr26 4.8 mg/kg 5.6 mg/kg 6.4 mg/kg 8.0 mg/kg Dose Levels |
| • n = 6 USC patients enrolled • Patients with at least ≥12 weeks follow-up • Other: ̶1 PR 1.6 mg/kg ̶1 PR 7.2 mg/kg (has not reached 12 weeks) 18 Uterine Serous Carcinoma (4.8 – 8.0 mg/kg) On treatment Evaluable PR ORR n = 3 2 66.7% 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 5203001 - USC - 4R 5201006 - USC - 3R 5201005 - USC- 2R 5206003 - USC - 3R 5205006 - USC - 2R 5201001 - USC - 1R 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 Weeks on Treatment Data cut 07Apr26 • Rare and highly aggressive form of endometrial cancer • Accounts for ~10% of uterine cancer, but causes ~40% of uterine cancer deaths • Rapid progression and poor clinical outcomes • Treated with platinum-based chemotherapy cPR uPR SD RECIST PD cPR: confirmed partial response; uPR: unconfirmed partial response Data cut 07Apr26 Dose Levels 6.4 mg/kg 7.2 mg/kg 8.0 mg/kg |
| •ORR (RECIST 1.1) •PFS SIM0505 Development Plan: Dose Optimization 19 9.6 mg/kg (n = 4) COMPLETED DOSE ESCALATION INITIATED DOSE OPTIMIZATION PLANNING PIVOTAL TRIAL •Generating recommended pivotal trial dose *TPC: treatment of physician’s choice PROC & USC PROC Q3W 8.0 mg/kg (n = 10) 6.4 mg/kg (n = 13) 4.8 mg/kg (n = 6) 3.2 mg/kg (n = 7) 1.6 mg/kg (n = 3) n = 59 (US = 25 & China = 34) Up to n = 120 Up to n = 430 7.2 mg/kg (n = 20-40) 6.4 mg/kg (n = 20-40) R 1:1 SIM0505 (n = 215) TPC* (n = 215) Dose Escalation Intermediate Doses + 7.2 mg/kg (n = 10) 5.6 mg/kg (n = 6) 5.6 mg/kg (n = 20-40) Q3W Q3W Ovarian, USC, RCC, EC |
| 20 SIM0505 Roadmap to Potential Best-in-Class CDH6 ADC ✓ Initiated dose optimization (5.6, 6.4 & 7.2 mg/kg) ✓ Additional sites in US, China, Canada & 4 European countries ✓ Securing supply chain & preparing for pivotal study ✓ RCC and NSCLC potential near-term development expansions PRODUCT DEVELOPMENT SIM0505 ✓ 55% ORR in gynecologic cancers ✓ Therapeutic window defined ✓ Observed to be well-tolerated ✓ Fast track granted for PROC |
| POTENTIAL FOR IMPROVED SAFETY & EFFICACY Opportunity to Develop Differentiated CDH6 ADC Therapeutic 21 CDH6 ADC ONGOING DOSE OPTIMIZATION TRIAL IN US & CHINA UPDATE DOSE OPTIMIZATION 1Q 2027 SIM0505 |
| 22 LNCB74 – B7-H4 ADC for Ovarian Cancer ONGOING DOSE ESCALATION • Differentiated ADC with unique linker • Trial ongoing in US • CLIA validated IHC assay for patient selection PLANNING DOSE OPTIMIZATION • 2 doses • 80 patients • Defining recommended Ph2 dose |
| LNCB74 is a Differentiated Anti-B7-H4 MMAE ADC Fc Modification Protects immune cells Tumor Selectivity Glucuronidase cleavable linker provides improved safety & increased efficacy 23 MMAE DAR 4 Improves targeted release and safety Antibody Linker Payload STRUCTURAL DIFFERENTIATION |
| LNCB74 Uses Differentiating Glucuronidase Linker Designed for Improved Safety & Increased Efficacy 24 Bloodstream Tissues Cancer Cell Bystander Effect Linker Glucuronidase cleavable Payload Tubulin inhibitor Conjugation Site Specific DAR 4 •Efficient release of toxin •Higher concentration Stable Potent Solution Reduced Toxicity + + Transfer to albumin Released by platelets & neutrophils Unstable Toxicity •Inefficient release of toxin •Lower concentration Less potent Limitation Linker Protease or esterase cleavable Payload Tubulin or Topo-1 inhibitors Conjugation Site Specific or non-specific cysteine DAR ~4, 6, 8 Val-cit Linkers Glucuronidase Linker |
| 25 LNCB74 Showed Potent Anti-Tumor Activity in CDX and PDX Models OVARIAN (OVCAR-3-B7-H4-OE) Days from Treatment Initiation Mean Volume (mm3) +/- SEM TNBC (CTG-0012) Mean Volume (mm3) +/- SEM Days from Treatment Initiation BREAST (ZR-75-1) Days from Treatment Initiation Mean Tumor Volume (mm3) +/- SEM CDX PDX Q7D x 3 8 mice / group 1.5 mg/kg: Q7D x 3 4.5 mg/kg: single dose 8 mice / group Single dose 5 mice / group 0 7 14 21 28 35 0 500 1000 1500 2000 No Treatment LNCB74 (6 mg/kg) LNCB74 (3 mg/kg) LNCB74 (1 mg/kg) 0 7 14 21 28 35 42 49 0 500 1000 1500 2000 No Treatment LNCB74 (6 mg/kg) 100% CRs 0 7 14 21 28 35 42 0 500 1000 1500 2000 No Treatment LNCB74 (1.5 mg/kg) LNCB74 (4.5 mg/kg) |
| LNCB74 Development Plan 26 Cohort 6 ONGOING DOSE ESCALATION PLANNING DOSE OPTIMIZATION • Recommended pivotal trial dose Q3W Breast, Ovarian, Endometrial, ACC-1 Cohort 5 Cohort 4 Cohort 3 Cohort 2 Cohort 1 TOTAL n = 54 TOTAL n = 80 Dose Level X Dose Level Y 2 Tumor Types ACC-1: Adenoid Cystic Carcinoma type 1 |
| Advancing LNCB74 Development Cohort 1 Cohort 2 Cohort 3 Cohort 4 Backfill Cohorts 27 Dose Expansion • 6 dose cohorts • Regimen Q3W • n = 54 subjects • 2 dose cohorts • 2 tumor types • n = 80 subjects • Pre & on treatment biopsies Patient selection strategy Patient selection strategy Dose Escalation Dose Expansion Cohort 5 Cohort 6 BREAST OVARIAN ENDOMETRIAL Ph1 Dose Escalation Study Initiated January 2025 Protocol Amendment Readout: Scans every 6 weeks Endpoint: Safety & ORR |
| 28 Product Life Cycle Management: Options to Address Resistance LNCB74 B7-H4 Tubulin inhibitor SIM0505 CDH6 Topoisomerase 1 inhibitor CONCURRENT ADMINISTRATION COMBO SEQUENCED ADMINISTRATION OR LNCB74 SIM0505 LNCB74 SIM0505 SIM0505 LNCB74 OR |
| DESIGNED TO IMPROVE SAFETY & INCREASE EFFICACY Opportunity to Develop Differentiated B7-H4 ADC Therapeutic 29 B7-H4 ADC UNMET NEED IN BREAST & GYNECOLOGICAL CANCERS PATIENT SELECTION STRATEGY |
| Programs Available for Partnering 30 PROGRAMS TARGET CELLS DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NC410 Combo LAIR-2 Extracellular Matrix NC525 LAIR-1 Leukemia NC605 S15 Osteoclasts NC181 APOE4 Microglia & Neurons Alzheimer’s Disease Osteogenesis Imperfecta Acute Myeloid Leukemia Colorectal (CRC) Ovarian |
| 31 Expected Milestones & Deliverables • SIM0505 (CDH6) update dose optimization in PROC 1Q 2027 and initiate dose optimization in USC 4Q 2026 • LNCB74 (B7-H4) trial progress update in 2H 2026 (Breast, Ovarian, Endometrial and ACC-1) 2026 UPDATES PHASE 1 CLINICAL ASSETS • SIM0505 and B7-H4 ADCs • Differentiated ADCs RUNWAY • $29.7M as of March 31, 2026 • Into 1Q 2027 |
FAQ
What Phase 1 SIM0505 results did NextCure (NXTC) report in gynecologic cancers?
NextCure reported encouraging Phase 1 dose escalation data for SIM0505 in gynecologic cancers. Among 20 patients in therapeutic dose cohorts with at least 12 weeks of follow-up, the objective response rate was 55% (11/20) by RECIST 1.1, in heavily pre-treated ovarian and uterine serous carcinoma patients.
What were the SIM0505 objective response rates in ovarian and uterine serous carcinoma patients?
In the Phase 1 study, ovarian cancer patients (n=17) treated with SIM0505 at 4.8–8.0 mg/kg had a 52.9% objective response rate (9/17). Uterine serous carcinoma patients (n=3) showed a 66.7% objective response rate (2/3), all assessed using RECIST 1.1 criteria.
How many patients were included in the SIM0505 Phase 1 dose escalation study for NextCure (NXTC)?
The SIM0505 Phase 1 dose escalation study enrolled 59 heavily pre-treated patients with advanced solid tumors. Patients were treated in the U.S. (n=25) and China (n=34) at doses ranging from 1.6 mg/kg to 9.6 mg/kg, without preselection for CDH6 expression, as of the April 7, 2026 data cutoff.
What safety profile did NextCure report for SIM0505 in the Phase 1 trial?
NextCure reported that SIM0505 safety data in 59 patients showed predominantly hematologic treatment-emergent adverse events, plus nausea and vomiting. Grade 3 and 4 events were mostly hematologic and described as manageable without primary prophylaxis, though some higher-dose patients required dose reductions or treatment discontinuation.
How long does NextCure (NXTC) expect its cash to fund operations after the SIM0505 update?
NextCure stated that its existing cash, cash equivalents and marketable securities are expected to fund planned operations into the first quarter of 2027. This estimate is based on internal assumptions and could change if the company’s capital needs or operating plans evolve.
What regulatory status does SIM0505 have and what cancer types is it targeting?
SIM0505 is an investigational antibody-drug conjugate directed to CDH6 and is being studied in advanced solid tumors, including gynecologic cancers and renal cell carcinoma. The U.S. Food and Drug Administration has granted Fast Track Designation for SIM0505 in platinum-resistant ovarian cancer.