On August 7, 2025 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, reported a business update and announced second quarter 2025 financial results (Press release, NextCure, AUG 7, 2025, View Source [SID1234654992]).

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"Our recent strategic acquisition of the global rights, excluding greater China, for SIM0505 targeting CDH6 (cadherin-6 or K-cadherin) positions us uniquely within the antibody-drug conjugate ("ADC") field. We now are developing ADCs against two clinically validated targets leveraging two distinct payloads, a Topoisomerase 1 Inhibitor (SIM0505) and a Tubulin Inhibitor (LNCB74)," said Michael Richman, NextCure’s president and CEO. "We are on track to dose our first SIM0505 patient in the United States this quarter and plan to provide program updates on both SIM0505 and LNCB74 by the fourth quarter of 2025, along with proof of concept data readouts in the first half of 2026."

Business Highlights and Near-Term Milestones

LNCB74 (B7-H4 ADC)

● First patient dosed in January 2025 in the Phase 1 trial, cleared cohort 3 in June 2025.
● Currently treating patients in cohort 4.
● Plan to initiate backfill cohorts in the second half of 2025.
● Plan to provide a program update by the fourth quarter of 2025 and proof of concept data readout in the first half of 2026.

SIM0505 (CDH6 ADC)

● Acquired global rights, excluding greater China, where Simcere Zaiming will retain rights.
● Phase 1 clinical trial ongoing in China with initial data as of April 16, 2025 reporting clinical activity in cohort 1 with a partial response based on a six-week assessment.
● Investigational New Drug application transferred to NextCure in June 2025, with anticipated first patient dosed in the US within the third quarter of 2025.
● Plan to provide a program update by the fourth quarter of 2025 and a proof of concept data readout, including data from Simcere Zaiming’s ongoing Phase 1 trial, in the first half of 2026.

Assets For Which We Are Seeking Partners

● Clinical programs NC410 (LAIR-2 fusion) and NC525 (LAIR-1 antibody).
● Preclinical data for NC181 (ApoE4), a humanized antibody for the treatment of Alzheimer’s disease, have demonstrated amyloid clearance, prevention of amyloid deposition, plaque clearance and reduced neuroinflammation.
● Preclinical data for NC605 (Siglec-15), a humanized antibody for the treatment of osteogenesis Imperfecta (OI), have demonstrated that NC605 treatment reduced bone loss and enhanced bone quality in mice with OI.

Other

● Simcere Zaiming US affiliate $2.0 million equity investment in NextCure in June 2025.
● Regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing.
Financial Results for Quarter Ended June 30, 2025

● Cash, cash equivalents, and marketable securities as of June 30, 2025 were $35.3 million as compared to $68.6 million as of December 31, 2024. The decrease of $33.3 million was primarily due to cash used to fund operations. We expect current financial resources to be sufficient to fund operating expenses and capital expenditures into mid-2026.
● Research and development expenses were $24.1 million for the three months ended June 30, 2025, as compared to $12.4 million for the three months ended June 30, 2024. The increase of $11.7 million was due to $17.0 million of up-front license fees incurred in connection with the licensing agreement announced June 16, 2025. This fee was partially offset by lower costs related to other programs, lower preclinical development costs and lower personnel-related costs.
● General and administrative expenses were $3.2 million for the three months ended June 30, 2025, as compared to $4.1 million for the three months ended June 30, 2024. The decrease of $0.9 million was primarily related to lower personnel costs and lower insurance costs.
● Net loss was $26.8 million for the three months ended June 30, 2025, as compared to a net loss of $15.4 million for the three months ended June 30, 2024 as the $17.0 million up-front license fee was partially offset by lower other research and development costs and lower general and administrative costs as described above.