NextCure(NXTC) - 2025 Q3 - Quarterly Report

Financial Performance - The company reported a net loss of $8.6 million for the three months ended September 30, 2025, compared to a net loss of $11.5 million for the same period in 2024, indicating a 25.2% improvement in quarterly losses [92]. - For the nine months ended September 30, 2025, the net loss was $46.4 million, slightly higher than the $44.1 million loss for the same period in 2024, reflecting a 5.2% increase in losses year-over-year [92]. - As of September 30, 2025, the company had an accumulated deficit of $426.5 million, primarily due to research and development and general administrative expenses [92]. - Net loss for the three months ended September 30, 2025 was $8.6 million, a decrease of $2.9 million from the net loss of $11.5 million in the same period in 2024 [106]. - General and administrative expenses for the nine months ended September 30, 2025 decreased by $2.4 million to $9.7 million compared to the same period in 2024 [112]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $42.0 million, compared to $33.8 million for the same period in 2024 [123]. - Total external research and development expenses for the nine months ended September 30, 2025 increased by $7.6 million to $27.6 million compared to the same period in 2024 [107]. - Net cash provided by investing activities for the nine months ended September 30, 2025 was $19.6 million, down from $48.3 million in the same period in 2024 [124]. - There were no restructuring and asset impairment charges for the three and nine months ended September 30, 2025, compared to $2.5 million in the same periods in 2024 [113]. Funding and Cash Position - The company raised approximately $425 million in gross proceeds from equity instruments since inception through September 30, 2025, with an additional $25 million received from a former collaboration partner [92]. - The company has cash, cash equivalents, and marketable securities totaling $29.1 million as of September 30, 2025, which is insufficient to fund planned operations for the next year [93][94]. - As of September 30, 2025, the company had cash and cash equivalents of $29.1 million, which may not be sufficient to fund operations for the next year [117]. - The company entered into a sales agreement to sell up to $75 million of common stock, but no shares were sold in the three months ended September 30, 2025 [116]. Research and Development - The company is advancing its product candidate SIM0505, which is currently in Phase 1 dose escalation studies in China for treating solid tumors, with proof of concept data expected in the first half of 2026 [87]. - The FDA accepted an IND application for the company's product candidate LNCB74 in December 2024, with the first patient dosed in January 2025 and proof of concept data also expected in the first half of 2026 [89]. - The company plans to incur substantial expenditures in the foreseeable future to advance SIM0505 and LNCB74 through clinical development and regulatory approval processes [95]. - Research and development expenses for the three months ended September 30, 2025 decreased by $2.6 million to $6.1 million compared to the same period in 2024 [106]. Operational Changes - The company has paused internal manufacturing operations and reduced its workforce as part of a restructuring effort to align with its focused pipeline [90]. - The company does not expect to generate product revenue until it obtains marketing approval for its product candidates, with significant doubt about its ability to continue as a going concern [94][96]. Accounting and Reporting - Recent accounting pronouncements may impact the company's financial position and results of operations [134]. - As a "smaller reporting company," the company is not required to provide certain market risk disclosures [135].