NXTC

EX-99.1

2 nxtc-20260507xex99d1.htm

EX-99.1

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Exhibit 99.1

NextCure Provides Business Update and

Reports First Quarter 2026 Financial Results

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–SIM0505/CDH6 ADC dose optimization initiated in gynecologic cancers

–SIM0505 Phase 1 dose escalation study data to be presented at ASCO 2026

–LNCB74 Phase 1 dose escalation trial update planned in second half of 2026

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BELTSVILLE, MD – May 7, 2026 (GLOBE NEWSWIRE) – NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies to treat cancer, today provided a business update and reported first quarter 2026 financial results.

"Our SIM0505 program reached critical milestones this quarter, headlined by the U.S. Food and Drug Administration (FDA) granting Fast Track designation for platinum-resistant ovarian cancer (PROC) and the upcoming presentation of initial Phase 1 data at the American Society for Clinical Oncology (ASCO 2026)," said Michael Richman, President and CEO of NextCure. "We believe Fast Track designation validates the potential of this CDH6 antibody drug conjugate (ADC) and the urgent need for new therapies. As we prepare to present our data at ASCO 2026, we are also focusing on accelerating development, with plans to increase our U.S. trial sites and expand our footprint into Canada and Europe. With the recent initiation of the dose optimization this month, we are fully committed to bringing this transformative treatment to patients."

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Business Highlights and Near-Term Milestones

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SIM0505 (CDH6 ADC): Phase 1 dose escalation data expected in Q2 2026

SIM0505 is a novel ADC directed to cadherin-6 (CDH6 ADC), overexpressed in several cancers including ovarian cancer, with limited expression in healthy tissues. SIM0505 features a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window.

●Received Fast Track designation for the treatment of women with PROC from the FDA.

●Data from the Phase 1 open-label dose escalation study in patients with advanced solid tumors with a focus on gynecological cancers and an emphasis on PROC (NCT06792552) are expected to be presented at ASCO 2026 on June 1, 2026, including results from patients in the U.S. and China.

●Announced in May 2026 the initiation of the Phase 1 dose optimization study in gynecologic cancers by dosing patients with PROC. NextCure anticipates increasing the number of trial sites in the second half of 2026, including the activation of sites in Canada and Europe, with continued study site additions in 2027.

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LNCB74 (B7-H4 ADC): Ongoing enrollment in Phase 1 dose escalation

LNCB74 is a novel ADC directed to B7-H4, overexpressed in several cancers, with limited expression in healthy tissues. LNCB74 features a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload.

●Ongoing open-label Phase 1 dose escalation study (NCT06774963) continues to prioritize patients with high B7-H4 expression in breast and gynecological cancers, as well as the inclusion of patients with adenoid cystic carcinoma type 1. NextCure intends to backfill patients to investigate particular dose levels and schedules in the expected therapeutic window.

●Trial progress update planned in the second half of 2026.

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Financial Results for the Quarter Ended March 31, 2026

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●Cash, cash equivalents, and marketable securities as of March 31, 2026 were $29.7 million as compared to $41.8 million as of December 31, 2025. The decrease of $12.1 million was primarily due to cash used to fund operations of $13.4 million, partially offset by proceeds of $1.2 million from equity sales under our existing ATM program. NextCure expects current financial resources to be sufficient to fund operating expenses and capital expenditures into the first half of 2027 through proof-of-concept for SIM0505.

●Research and development expenses were $6.8 million for the three months ended March 31, 2026, as compared to $7.9 million for the three months ended March 31, 2025. The decrease of $1.1 million was due to lower costs related to deprioritized programs which were largely offset by costs for the SIM0505 program, and lower personnel costs, primarily non-cash stock compensation costs and lower depreciation.

●General and administrative expenses were $3.3 million for the three months ended March 31, 2026, as compared to $3.7 million for the three months ended March, 2025. The decrease of $0.4 million was primarily related to lower non-cash stock compensation costs.

●Net loss was $9.8 million for the three months ended March 31, 2026, as compared to a net loss of $11.0 million for the three months ended March 31, 2025. The lower net loss for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 was driven by the lower research and development and general and administrative ex

NextCure, Inc._March 5, 2026 0001661059false00016610592026-03-052026-03-05 ​

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): March 5, 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 2.02Results of Operations and Financial Condition ​ On March 5, 2026, NextCure, Inc. (the “Company”) issued a press release announcing its financial results for the year ended December31, 2025. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1. ​ The information furnished in this Item 2.02 (including Exhibit 99.1) 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, and is not incorporated by reference into any filing under the securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. ​ ​ ​ Item 9.01Financial Statements and Exhibits ​ (d) Exhibits ​ Exhibit No. Description 99.1 Press Release issued by NextCure, Inc. dated March 5, 2026 104 Cover Page Interactive Data File (formatted as inline XBRL). ​ ​ ​ ​

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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: March 5, 2026

NEXTCURE, INC.

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By: /s/ Steven P. Cobourn

Name: Steven P. Cobourn

Title: Chief Financial Officer

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NextCure, Inc._January 23, 2026 0001661059false00016610592026-01-232026-01-23 ​

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): January 23, 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 2.02Results of Operations and Financial Condition ​ On January 23, 2026, NextCure, Inc. (the “Company”) issued a press release announcing preliminary results that as of December 31, 2025, it had approximately $41.8 million in cash, cash equivalents and marketable securities. The Company expects current financial resources to be sufficient to fund planned operating expenses and capital expenditures into the first half of 2027. ​ Because the Company’s consolidated financial statements for the year ended December 31, 2025 have not yet been finalized, the preliminary statement of the Company’s cash, cash equivalents and marketable securities as of December 31, 2025 in this Item 2.02 is unaudited and subject to adjustment. ​ Item 7.01Regulation FD Disclosure ​ A copy of the press release referenced in Item 2.02 hereof is filed as Exhibit 99.1 to this Current Report on Form 8-K and is hereby incorporated by reference into this Item 7.01. Additionally, on January 23, 2026, the Company updated its corporate presentation.  A copy of the corporate presentation is attached hereto as Exhibit 99.2 and is hereby incorporated by reference into this Item 7.01. Except to the extent described in Item 8.01 hereof, the information contained in this Item 7.01, including Exhibits 99.1 and 99.2, 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, and is not incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. ​ Item 8.01Other Events ​ The information in Item 2.02 hereof is incorporated by reference into this Item 8.01. Additionally, the press release referenced in Items 2.02 and 7.01 hereof included the following program updates for the Company’s two antibody drug conjugate (ADC) programs: ●Data from the SIM0505 Phase 1 open-label dose escalation study are anticipated to be presented in the second quarter of 2026, including results from patients in the U.S. and China.  The SIM0505 study (NCT06792552) is evaluating patients with advanced solid tumors with a focus on gynecological cancers and an emphasis on platinum resistant ovarian cancer.  The Company is adding clinical sites and increasing SIM0505 clinical drug supply in anticipation of initiating dose optimization in the first half of 2026. ​ ●Dosing of patients has commenced in higher dose cohorts for the ongoing open-label Phase 1 dose escalation LNCB74 study (NCT06774963) following the November 2025 protocol amendment announcement. Higher dose cohorts will prioritize patients with high B7-H4 expression in breast and gynecological cancers, while now including adenoid cystic carcinoma type 1.  Proof-of-concept data, previously anticipated in the firs