NextCure, Inc. Provides Business Update and Reports Full Year 2025 Financial Results

Key Highlights for Investors

• Upcoming Clinical Milestones: NextCure anticipates key data readouts and trial expansions in 2026 for its lead programs:
• SIM0505 (CDH6 ADC): Phase 1 dose escalation data expected in Q2 2026, with initiation of dose optimization for platinum resistant ovarian cancer (PROC) also slated for Q2 2026.
• LNCB74 (B7-H4 ADC): Ongoing Phase 1 dose escalation enrollment; trial update planned for second half of 2026.
• Strategic Expansion: NextCure plans to double the number of U.S. trial sites and expand into Canada and Europe in the second half of 2026, with further study site additions expected in 2027.
• Financial Position:
• Cash, cash equivalents, and marketable securities were \$41.8 million as of December 31, 2025, down from \$68.6 million at the end of 2024.
• The decrease was mainly due to \$49.6 million used for operations, including \$13.5 million in upfront license fees and milestone payments to Simcere Zaiming Pharmaceutical Co., Ltd. for SIM0505 rights, offset by \$22.3 million from equity sales, including a \$21.5 million private placement in November 2025.
• NextCure expects current financial resources to fund operations and capital expenditures into the first half of 2027, including through proof-of-concept for SIM0505.
• Operational Metrics:
• Research and development expenses for 2025 increased to \$44.9 million (up \$3.4 million from 2024), mostly due to license fees and milestone payments for SIM0505.
• General and administrative expenses dropped to \$12.7 million (down \$3.0 million from 2024), primarily due to lower personnel costs.
• Net loss for 2025 was \$55.8 million, nearly unchanged from 2024 (\$55.7 million).
• Net loss per share improved to \$19.65, compared to \$23.88 in 2024 (restated for the one-for-twelve reverse stock split conducted July 14, 2025).
• Weighted average shares outstanding increased to 2,842,448 from 2,330,386 in 2024.
• Total assets fell to \$50.2 million (from \$80.9 million), and total stockholders’ equity decreased to \$34.9 million (from \$65.5 million).

Program Details

• SIM0505 (CDH6 ADC):
  • A novel antibody-drug conjugate targeting cadherin-6, which is overexpressed in several cancers (notably ovarian cancer) and minimally expressed in healthy tissues.
  • Features a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, rapid systemic clearance, and improved safety profile.
  • NextCure acquired SIM0505 in June 2025 from Simcere Zaiming Pharmaceutical Co., Ltd., retaining exclusive global rights except for China, Hong Kong, Macau, and Taiwan.
  • Phase 1 trial (NCT06792552) is ongoing in advanced solid tumors, with an emphasis on platinum resistant ovarian cancer. Study sites include the U.S. and China, with planned expansion to Canada and Europe.
• LNCB74 (B7-H4 ADC):
  • Targets B7-H4, overexpressed in several cancers with limited expression in healthy tissues.
  • Features a proprietary tumor-selective cleavable linker and MMAE payload.
  • Currently in a Phase 1 dose escalation trial (NCT06774963). The protocol was amended in November 2025 to prioritize patients with high B7-H4 expression, focusing on breast and gynecological cancers, and including adenoid cystic carcinoma type 1.
  • NextCure shares global co-development rights with LigaChem Biosciences, Inc. on a 50-50 cost share basis.

Important Shareholder Information & Potential Price Sensitivity

• Clinical Data Readouts and Trial Expansions: The anticipated release of Phase 1 SIM0505 data in Q2 2026 and expansion into new geographies and patient populations are major potential catalysts for share price movement. Positive results or swift enrollment could increase investor confidence.
• Financial Position and Capital Resource Outlook: NextCure’s current financial resources are expected to last until the first half of 2027, covering proof-of-concept for SIM0505. Any changes in funding or unexpected trial costs could be impactful for shareholders.
• Recent Equity Raises: The \$21.5 million private placement in November 2025 and overall \$22.3 million equity sales highlight active capital raising, which can affect dilution and share pricing.
• Reverse Stock Split: The one-for-twelve reverse split on July 14, 2025 affects per-share metrics and could influence share price perception.
• Risks & Uncertainties: NextCure emphasizes substantial risks related to clinical development, regulatory approval, commercialization, and financial sustainability. Shareholders should be aware that positive preclinical results may not translate to clinical success, and the company has not yet achieved commercial sales.

Selected Financial Information (Year Ended December 31, 2025 and 2024)

Contact Information

• Timothy Mayer, Ph.D., Chief Operating Officer, NextCure, Inc. ([email protected], (240) 762-6486)
• Mike Moyer, Managing Director, LifeSci Advisors, LLC ([email protected], (617) 308-4306)

Disclaimer

This article contains forward-looking statements based on NextCure, Inc.’s latest disclosures and financial updates. Actual results may differ materially due to risks and uncertainties, including but not limited to clinical trial outcomes, regulatory decisions, market conditions, and the company’s ability to secure additional funding. Investors are encouraged to review NextCure’s SEC filings for more detailed risk information. This article is for informational purposes only and does not constitute investment advice. Please consult a financial advisor before making any investment decisions.

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