Form 8-K

8-K — NextCure, Inc.

Accession: 0001104659-26-068604

Filed: 2026-06-01

Period: 2026-06-01

CIK: 0001661059

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — nxtc-20260601x8k.htm (Primary)

EX-99.1 (nxtc-20260601xex99d1.htm)

EX-99.2 (nxtc-20260601xex99d2.htm)

EX-99.3 (nxtc-20260601xex99d3.htm)

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8-K

8-K (Primary)

Filename: nxtc-20260601x8k.htm · Sequence: 1

NextCure, Inc._June 1, 2026

0001661059false00016610592026-06-012026-06-01

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 1, 2026

NextCure, Inc.

(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction of incorporation)

001-38905

(Commission File Number)

47-5231247

(IRS Employer Identification No.)

9000 Virginia Manor Road, Suite 200

Beltsville, Maryland

20705

(Address of principal

(Zip Code)

executive offices)

Registrant's telephone number, including area code: (240) 399-4900

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value per share

NXTC

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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 (%)

16 (27.1%)

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.

November

Dated: June 1, 2026

NEXTCURE, INC.

By:

/s/ Steven P. Cobourn

Name:

Steven P. Cobourn

Title:

Chief Financial Officer

EX-99.1

Filename: nxtc-20260601xex99d1.htm · Sequence: 2

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 (%)

16 (27.1%)

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)

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

All trademarks are the property of their respective owners.

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

EX-99.2

Filename: nxtc-20260601xex99d2.htm · Sequence: 3

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).

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)

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)

EX-99.3

Filename: nxtc-20260601xex99d3.htm · Sequence: 4

Exhibit 99.3

Corporate Presentation

J U N E 2026

N A S D A Q : N X T C

Forward-Looking Statements

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.

In the Fight Against Cancer

Harnessing the Power of Targeted Therapy

ADC Pipeline Progress

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)

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

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

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

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)

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)

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

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

13.6

15.3

16.9

22.0

23.7

25.4

28.8

33.9

35.6

37.3

47.5

47.4

50.8

50.9

52.5

62.8

0.0

3.4

0.0

5.1

1.7

0.0

5.1

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

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

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

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

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

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

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

Weeks on Treatment

Ovarian Cancer (4.8 – 8.0 mg/kg)

• 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)

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

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)

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 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

CDH6 ADC

ONGOING DOSE

OPTIMIZATION TRIAL

IN US & CHINA

UPDATE DOSE

OPTIMIZATION 1Q 2027

SIM0505

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

MMAE DAR 4

Improves targeted release and

safety

Antibody Linker Payload

STRUCTURAL DIFFERENTIATION

LNCB74 Uses Differentiating Glucuronidase Linker Designed

for Improved Safety & Increased Efficacy

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

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

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

500

1000

1500

2000

No Treatment LNCB74 (6 mg/kg)

100% CRs

0 7 14 21 28 35 42

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

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

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

Product Life Cycle Management: Options to Address Resistance

LNCB74

B7-H4

Tubulin inhibitor

SIM0505

CDH6

Topoisomerase 1 inhibitor

CONCURRENT ADMINISTRATION

COMBO

SEQUENCED ADMINISTRATION

LNCB74 SIM0505

LNCB74

SIM0505

SIM0505 LNCB74

DESIGNED TO IMPROVE

SAFETY & INCREASE

EFFICACY

Opportunity to Develop Differentiated B7-H4 ADC Therapeutic

B7-H4 ADC

UNMET NEED IN BREAST &

GYNECOLOGICAL CANCERS

PATIENT SELECTION

STRATEGY

Programs Available for Partnering

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

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

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