NXTC

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 BELTSVILLE, Md., May 07, 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." Business Highlights and Near-Term Milestones 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...

Data readout for SIM0505/CDH6 ADC Phase 1 dose escalation study and initiation of dose optimization in ovarian cancer are both anticipated in Q2 2026 LNCB74 Phase 1 dose escalation trial update planned in second half of 2026 BELTSVILLE, Md., March 05, 2026 (GLOBE NEWSWIRE) -- 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, today provided a business update and reported full year 2025 financial results. “2026 is on track to be transformational for NextCure, as we set the stage to present clinical dose escalation data from the Phase 1 trial for SIM0505, in development for multiple cancers,” said Michael Richman, President and CEO of NextCure. “Since acquiring the program in June of 2025, we have made rapid clinical and regulatory progress and soon expect to begin enrolling platinum resistant ovarian cancer patients in the Phase 1 dose optimization study. To accelerate the program, we plan to double the number of U.S. trial sites and expand our footprint into multiple other countries.” Business Highlights and Near-Term Milestones 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. Data from the Phase 1 open-label dose escalation study is expected 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 (PROC). Initiation of Phase 1 dose optimization study in ovarian cancer expected in the second quarter of 2026 with a continued focus on PROC. The Company anticipates doubling 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. LNCB74 (B7-H4 ADC): Ongoing enrollment in Phase 1 dose escalation LNCB74 is a novel ADC directed to B7-H4, overexpressed in several ca...

BELTSVILLE, Md., Nov. 05, 2025 (GLOBE NEWSWIRE) -- 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, today provided a business update and reported third quarter 2025 financial results. “We have made significant progress advancing our promising ADC programs,” said Michael Richman, NextCure’s president and CEO. “We recently began U.S. enrollment in the Phase 1 trial for SIM0505, our CDH6 ADC, initiating at a mid-tier dose range where multiple clinical responses were observed in China by our partner Simcere Zaiming. We expect to advance into higher-dose cohorts in the US shortly, as is currently occurring in China. We believe the ability to dose at levels that match or exceed competitor CDH6-targeting ADCs should demonstrate the promise of this program. We also received FDA clearance for our LNCB74 protocol amendment, giving us the ability to add higher dose escalation cohorts. We plan to provide proof of concept data readouts on SIM0505 and LNCB74 in the first half of 2026.” Business Highlights and Near-Term Milestones SIM0505 (CDH6 ADC) A novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. Acquired global rights in June 2025, excluding greater China where Simcere Zaiming retained rights. First U.S. patient dosed in October 2025 at a mid-tier dose level where multiple responses have been observed along with good tolerability in the ongoing Chinese trial. Proof of concept data readout, including data from Simcere Zaiming’s ongoing Phase 1 trial, in the first half of 2026. LNCB74 (B7-H4 ADC) A novel ADC directed to B7-H4, featuring a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload. Co-developed with LigaChem Biosciences Inc. in a 50-50 cost share arrangement. Received Food and Drug Administration (FDA) acceptance of a protocol amendment giving us the ability to add higher dose escalation cohorts. Proof of concept data readout in the first half of 2026. Financial Results for Quarter Ended September 30, 2025 Cash, cash equivalents, and marketable securities as of September 30, 2025 w...

Announced strategic partnership with Simcere Zaiming for Phase 1 program SIM0505 (CDH6 ADC) with plans to dose the first SIM0505 patient in the United States this quarter Currently in cohort 4 of the Phase 1 trial of LNCB74 (B7-H4 ADC) in multiple cancers Plan to provide SIM0505 and LNCB74 program updates by the fourth quarter of 2025, along with proof of concept data readouts in the first half of 2026 BELTSVILLE, Md., Aug. 07, 2025 (GLOBE NEWSWIRE) -- 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, today provided a business update and reported second quarter 2025 financial results. “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 firs...

Dosing cohort 3 of the Phase 1 trial of LNCB74 (B7-H4 ADC) in multiple cancers and plan to initiate backfill cohorts in the second half of 2025 Plan to provide a proof of concept data readout in the first half of 2026 Cash of approximately $55.9 million expected to fund operations into the second half of 2026 BELTSVILLE, Md., May 01, 2025 (GLOBE NEWSWIRE) -- 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, today provided a business update and reported first quarter 2025 financial results. “With our LNCB74 antibody-drug conjugate (“ADC”) program completing cohort 2 in April 2025, we are progressing as planned through the dose escalation portion of the Phase 1 study. We expect to be in a position to initiate backfill cohorts in the second half of the year with 10 active investigator sites, and an additional 3 sites projected to be onboard in May 2025. We plan to provide a proof of concept data readout in the first half of 2026,” said Michael Richman, NextCure’s president and CEO. Business Highlights and Near-Term Milestones LNCB74 (B7-H4 ADC) Dosed our first patient in January 2025 in the Phase 1 trial, cleared cohort 2 in April 2025 and currently dosing cohort 3. Expanded clinical footprint for the LNCB74 study with a total of 10 active trial sites. Plan to initiate backfill cohorts in the second half of 2025. Plan to provide a proof of concept data readout in the first half of 2026. Preclinical Non-Oncology Programs Seeking Partnering Preclinical data for NC181 (ApoE4), a humanized antibody for the treatment of Alzheimer’s disease, has 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), has demonstrated that NC605 treatment reduced bone loss and enhanced bone quality in mice with OI. Both programs could lead to investigational new drug (IND) filings within 12 to 18 months if financial support from partners or third parties is secured. Financial Results for Quarter Ended March 31, 2025 Cash, cash equivalents, and marketable securities as of March 31, 2025 were $55.9 million as compared to $68.6 million as of December 31, 2024. The decrease of $12.8 million w...