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NextCure Provides Business Update 

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NextCure (NASDAQ: NXTC) provided a business update on Jan 23, 2026, reporting clinical progress for two ADC programs and a preliminary year-end cash position.

SIM0505 (CDH6 ADC): Phase 1 dose-escalation data from U.S. and China cohorts are expected in Q2 2026; company is adding sites and increasing drug supply to start dose optimization in H1 2026. LNCB74 (B7-H4 ADC): dose escalation expanded into higher cohorts with prioritization of high B7-H4 breast and gynecological cancer patients; proof-of-concept timing delayed to a trial update in 2H 2026. Financials: preliminary cash and equivalents approx $41.8M, expected to fund operations into 1H 2027.

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Positive

  • SIM0505 Phase 1 data expected in Q2 2026
  • Increased SIM0505 clinical supply and added sites for H1 2026 dosing
  • Preliminary cash position of $41.8M funding into 1H 2027

Negative

  • LNCB74 proof-of-concept delayed to a trial update in 2H 2026
  • Preliminary cash of $41.8M may limit runway beyond 1H 2027

Key Figures

Year-end 2025 cash: $41.8 million Cash runway: into first half of 2027 SIM0505 Phase 1 data timing: Q2 2026 +5 more
8 metrics
Year-end 2025 cash $41.8 million Preliminary cash, cash equivalents and marketable securities as of 12/31/2025
Cash runway into first half of 2027 Company guidance on funding planned operating expenses and capex
SIM0505 Phase 1 data timing Q2 2026 Phase 1 dose escalation data expected for SIM0505 (CDH6 ADC)
SIM0505 dose optimization start first half of 2026 Planned initiation of dose optimization after dose escalation
LNCB74 proof-of-concept timing second half of 2026 Proof-of-concept data timing delayed; trial progress update expected instead
LNCB74 trial phase Phase 1 dose escalation Ongoing open-label study in higher dose cohorts
Key target cancers breast, gynecological, adenoid cystic carcinoma type 1 High B7-H4 expression prioritized in LNCB74 cohorts
Gynecologic focus platinum resistant ovarian cancer Primary focus indication in SIM0505 advanced solid tumor study

Market Reality Check

Price: $12.65 Vol: Volume 28,269 is slightly...
normal vol
$12.65 Last Close
Volume Volume 28,269 is slightly below 20-day average 31,387 with relative volume at 0.9. normal
Technical Shares at $12.65 are trading above the 200-day MA of $7.48 and 19.63% below the 52-week high.

Peers on Argus

NXTC was down 2.62% while peers were mixed: APLM -5.1%, PRTG -10.39% versus BCTX...

NXTC was down 2.62% while peers were mixed: APLM -5.1%, PRTG -10.39% versus BCTX +3.52%, BIVI +2.62%, CARM +10.48%, suggesting a stock-specific reaction.

Historical Context

5 past events · Latest: Nov 20 (Neutral)
Pattern 5 events
Date Event Sentiment Move Catalyst
Nov 20 Conference participation Neutral -1.6% Announcement of participation in Piper Sandler healthcare conference fireside chat.
Nov 17 PIPE financing Positive +2.7% Closed $21.5M PIPE to extend cash runway beyond planned 2026 ADC data.
Nov 12 Private placement Positive +9.0% Announced $21.5M private placement to support ADC programs and extend runway.
Nov 05 Earnings and update Negative -0.1% Q3 loss, cash decline, going‑concern language with ADC progress milestones.
Oct 16 Clinical trial update Positive +27.8% SIM0505 Phase 1 expansion into U.S. with early responses and favorable safety.
Pattern Detected

News-driven moves have generally aligned with headline tone, with clinical and financing updates often prompting positive price reactions.

Recent Company History

Over the last few months, NextCure has focused on advancing its ADC pipeline and shoring up its balance sheet. An October 2025-10-16 SIM0505 trial expansion into the U.S. coincided with a 27.75% move, while November private placement and PIPE financings totaling about $21.5M each supported cash runway into H1 2027 and drew positive reactions. Today’s update reiterates ADC timelines, introduces an LNCB74 proof‑of‑concept delay, and refines cash runway expectations in line with prior financing disclosures.

Regulatory & Risk Context

Active S-3 Shelf · $21.5 million
Shelf Active
Active S-3 Shelf Registration 2025-11-26
$21.5 million registered capacity

An S-3 shelf filed on 2025-11-26 registers 2,523,477 shares for resale from a prior private placement. NextCure already received approximately $21.5 million in gross proceeds from that financing and will not receive additional proceeds from resales, aside from about $1,815 if all pre-funded warrants at $0.001 are exercised.

Market Pulse Summary

This announcement updates timelines for NextCure’s SIM0505 and LNCB74 ADC programs while providing a...
Analysis

This announcement updates timelines for NextCure’s SIM0505 and LNCB74 ADC programs while providing an unaudited year-end $41.8M cash figure and runway into H1 2027. SIM0505 Phase 1 data are targeted for Q2 2026, whereas LNCB74 proof‑of‑concept has shifted to a later update in 2H 2026. In light of prior going‑concern language and recent financings, investors may watch upcoming trial readouts, cash usage trends, and any further regulatory or financing developments.

Key Terms

antibody drug conjugate, adc, pre-funded warrants, phase 1, +2 more
6 terms
antibody drug conjugate medical
"provided updates for its two antibody drug conjugate (ADC) programs"
An antibody drug conjugate is a targeted medical treatment that combines a special antibody with a powerful drug, allowing precise delivery of the medicine directly to cancer cells or other harmful cells in the body. For investors, it represents a sophisticated approach to therapy that could improve treatment effectiveness and reduce side effects, potentially leading to significant growth opportunities in the biotech and pharmaceutical sectors.
adc medical
"two antibody drug conjugate (ADC) programs and reported a preliminary"
An antibody-drug conjugate (ADC) is a targeted cancer medicine that pairs an antibody that recognizes specific markers on tumor cells with a potent cell-killing drug, connected so the toxic payload is delivered directly to the cancer. For investors, ADCs matter because successful ADCs can improve patient outcomes and reduce side effects compared with traditional chemotherapy, shaping clinical trial success, regulatory approval chances, commercial demand, and a company’s valuation much like a guided missile versus a general bomb.
pre-funded warrants financial
"pre-funded warrants to purchase up to 1,815,049 shares at $8.519"
Pre-funded warrants are financial instruments that give investors the right to purchase a company's stock at a set price, but with most or all of the purchase price paid upfront. They function like a coupon or gift card for stock, allowing investors to buy shares later at a fixed price, which can be beneficial if they want to avoid future price increases. This makes them important for investors seeking flexibility and certainty in their investment plans.
phase 1 medical
"Phase 1 dose escalation data update anticipated in Q2 2026"
Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.
dose escalation medical
"Phase 1 dose escalation expanded into higher dose cohorts"
Dose escalation is the process of gradually increasing the amount of a treatment or substance over time. In finance, it can refer to slowly raising investments or commitments to manage risk and assess performance. For investors, understanding dose escalation helps gauge how companies or strategies adjust their approaches, which can impact future growth or stability.
open-label medical
"open-label dose escalation study are anticipated to be presented"
Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

AI-generated analysis. Not financial advice.

  • SIM0505 (CDH6 ADC) Phase 1 dose escalation data update anticipated in Q2 2026
  • LNCB74 (B7-H4 ADC) Phase 1 dose escalation expanded into higher dose cohorts

BELTSVILLE, Md., Jan. 23, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to developing novel therapies to treat cancer, today provided updates for its two antibody drug conjugate (ADC) programs and reported a preliminary year-end 2025 cash position.

SIM0505 (CDH6 ADC): Phase 1 dose escalation data expected in Q2 2026
SIM0505 is a novel ADC directed to cadherin-6 (CDH6 ADC), which is overexpressed in several cancers 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.

  • Data from the 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 study (NCT06792552) is evaluating SIM0505 in 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.

LNCB74 (B7-H4 ADC): Ongoing 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.

  • Dosing has commenced in higher dose cohorts for the ongoing open-label Phase 1 dose escalation 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 first half of 2026, is delayed to accommodate enrollment; NextCure now expects to provide a trial progress update in second half of 2026.

Financial Position (unaudited) and Cash Runway

  • As of December 31, 2025, NextCure is reporting preliminary cash, cash equivalents and marketable securities of approximately $41.8 million. These preliminary selected financial results are unaudited and subject to adjustment.
  • The Company expects current financial resources to be sufficient to fund planned operating expenses and capital expenditures into the first half of 2027.

About SIM0505

SIM0505 is a novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (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 for the potential treatment of advanced solid tumors. NextCure has global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming.

About LNCB74

LNCB74 is novel antibody drug conjugate (ADC) directed to B7-H4, featuring a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload. LNCB74 is being evaluated in an open-label, Phase 1 study for the potential treatment of advanced solid tumors. NextCure shares global co-development rights with LigaChem Biosciences Inc through a 50-50 cost share arrangement.

About NextCure, Inc.

NextCure is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients who do not respond to, or have disease progression on, current therapies, 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.

Please visit "http://www.nextcure.com" for more information.

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 statements related to our cash runway 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,” “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: market and other conditions, positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and not having any products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization, including risks associated with reliance upon our collaborative partners and international vendors; NextCure’s ability to maintain listing of its common stock on the Nasdaq Global Select Market; and NextCure’s dependence on key personnel. 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 for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, 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, Ph.D.
NextCure, Inc.
Chief Operating Officer
(240) 762-6486
IR@nextcure.com


FAQ

When will NextCure (NXTC) report SIM0505 (CDH6 ADC) Phase 1 data?

NextCure expects to present SIM0505 Phase 1 dose-escalation data in Q2 2026.

What change occurred to LNCB74 (B7-H4 ADC) timing for NextCure (NXTC)?

LNCB74 proof-of-concept timing was delayed; NextCure now expects a trial progress update in 2H 2026.

How much cash did NextCure (NXTC) report as of December 31, 2025?

NextCure reported preliminary cash, cash equivalents and marketable securities of approximately $41.8 million.

Does NextCure (NXTC) have funding runway and until when?

The company expects current financial resources to fund planned operations into the first half of 2027.

Will NextCure (NXTC) expand SIM0505 dosing in 2026?

Yes; NextCure is adding clinical sites and increasing SIM0505 supply to initiate dose optimization in H1 2026.

Which patient groups are prioritized in higher LNCB74 dose cohorts for NXTC?

Higher LNCB74 dose cohorts will prioritize patients with high B7-H4 expression in breast and gynecological cancers and include adenoid cystic carcinoma type 1.
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BELTSVILLE