NextCure, Inc. (NASDAQ: NXTC) is a clinical-stage biopharmaceutical company dedicated to developing innovative medicines that treat cancer patients who do not respond to or have disease progression on current therapies. The company's focus is on leveraging its core strengths in understanding biological pathways, cell interactions, and the tumor microenvironment to advance differentiated mechanisms of action, including antibody-drug conjugates (ADCs), antibodies, and proteins.
Business Overview
NextCure's lead product candidate, NC410, is a fusion protein designed to block immune suppression mediated by LAIR-1, a receptor expressed on T cells. Early preclinical work suggests NC410 has the potential to remodel the tumor's extracellular matrix, removing a physical barrier to enhance T cell tumor killing. The company is currently conducting a Phase 1b/2 clinical trial evaluating NC410 in combination with Merck's anti-PD-1 therapy, KEYTRUDA, in immune checkpoint inhibitor (ICI) naïve ovarian and colorectal cancer patients.
The company's second clinical-stage asset, LNCB74, is a B7-H4 targeted ADC being developed in collaboration with LigaChem Biosciences. B7-H4 is a clinically validated target expressed on multiple tumor types, including breast, ovarian, and endometrial cancers. LNCB74 is positioned as a promising B7-H4 ADC with improved safety and efficacy profiles. NextCure and LigaChem are currently conducting preclinical activities, including GLP toxicology studies and GMP manufacturing, with plans to file an Investigational New Drug (IND) application in the fourth quarter of 2024.
In addition to its clinical programs, NextCure has several preclinical assets targeting chronic bone diseases and Alzheimer's disease that it is seeking to partner.
Financials
NextCure has not generated any revenue to date, as the company's product candidates are still in clinical development. For the fiscal year ended December 31, 2023, the company reported a net loss of $62.7 million, with no revenue and an annual operating cash flow of -$52.9 million and annual free cash flow of -$53.8 million.
For the first quarter of 2024, NextCure reported a net loss of $17.1 million, with no revenue. The company's research and development expenses for the quarter were $11.4 million, while general and administrative expenses were $4.4 million. Additionally, the company incurred $2.5 million in restructuring and asset impairment charges related to a prioritization and restructuring of its operations.
As of March 31, 2024, NextCure had cash, cash equivalents, and marketable securities of $96.0 million, which the company believes will be sufficient to fund its planned operations into the second half of 2026.
Liquidity
NextCure has financed its operations primarily through public offerings of its common stock, private placements of preferred stock, and an upfront payment from a former collaboration partner. The company has not generated any revenue from product sales to date, and it expects to continue to incur significant expenses as it advances its product candidates through clinical development and regulatory approval.
As of March 31, 2024, NextCure had $96.0 million in cash, cash equivalents, and marketable securities, which the company believes will be sufficient to fund its planned operations into the second half of 2026. The company may seek to raise additional capital through the sale of equity, debt financings, strategic alliances, and licensing arrangements to support its ongoing research and development activities and general operations.
Risks and Challenges
NextCure faces several risks and challenges common to clinical-stage biopharmaceutical companies, including the uncertainty of clinical trial outcomes, the potential for regulatory delays or denials, and the need to secure additional funding to support its operations and development programs. Specifically, the company's success will depend on its ability to demonstrate the safety and efficacy of its product candidates, obtain necessary regulatory approvals, and successfully commercialize any approved products, either independently or through partnerships.
Additionally, the company's reliance on third-party manufacturers and contract research organizations introduces risks related to the availability and quality of its drug supply and the timely execution of its clinical trials. NextCure also faces competition from other companies developing therapies that target the same or similar biological pathways, which could impact the commercial potential of its product candidates.
Outlook
In March 2024, NextCure announced a prioritization and restructuring of its operations to align with its focused pipeline. The company paused its internal manufacturing operations and reduced its workforce by approximately 37%. These actions are expected to extend the company's cash runway into the second half of 2026.
Regarding its clinical programs, NextCure expects to present data from the colorectal cancer cohort of the NC410 Phase 1b/2 trial at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2024, and data from the ovarian cancer cohort in the second half of 2024. The company also plans to file an IND for LNCB74 in the fourth quarter of 2024.
For its preclinical programs, NextCure is seeking to partner its assets targeting chronic bone diseases and Alzheimer's disease to allow the company to focus its resources on its core oncology pipeline.
Conclusion
NextCure is a clinical-stage biopharmaceutical company with a differentiated approach to cancer therapy development. The company's lead product candidates, NC410 and LNCB74, target important biological pathways and have the potential to address unmet needs for cancer patients. While the company faces the typical risks and challenges associated with drug development, its focused pipeline, recent restructuring, and cash runway into the second half of 2026 position it to continue advancing its innovative therapies. Investors should closely monitor NextCure's progress as it works to bring these promising candidates through clinical development and regulatory approval.