Business Overview and History
NextCure, Inc. (NASDAQ:NXTC) is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer. The company has a diverse pipeline of product candidates, including its lead asset LNCB74, an antibody-drug conjugate (ADC) targeting the B7-H4 protein.
NextCure was founded in 2015 and is headquartered in Beltsville, Maryland. The company's mission is to advance innovative medicines that treat cancer patients who do not respond to or have disease progression on current therapies. Since its inception, NextCure has devoted substantial resources to research and development, identifying business development opportunities, raising capital, and securing intellectual property rights related to its product candidates.
The company has financed its operations primarily through public offerings of its common stock, private placements of preferred stock, and upfront fees received under a former research and development collaboration agreement. In May 2019, NextCure closed its initial public offering, raising approximately $77 million in net proceeds. This was followed by an underwritten public offering in November 2019, which raised an additional $160.9 million in net proceeds.
In its early years, NextCure focused on building and optimizing its manufacturing capabilities, including establishing a purpose-built, dedicated, state-of-the-art cGMP manufacturing facility. The company also developed a proprietary FIND platform to identify targets and develop therapies. NextCure's initial product candidates included NC318, NC410, NC525, and LNCB74.
However, the company faced a significant setback in 2022 when it decided to discontinue its Phase 2 clinical trial for NC318 monotherapy based on then-current efficacy data. This led to a reevaluation of its pipeline and resources, resulting in a restructuring and prioritization announced in March 2024. As part of this restructuring, NextCure paused its internal manufacturing operations and reduced its workforce by approximately 37%.
The company's lead program, LNCB74, is a B7-H4-targeting ADC being developed in partnership with LigaChem Biosciences. B7-H4 is a clinically validated target expressed on multiple tumor types, including breast, ovarian, and endometrial cancers. Preclinical studies have demonstrated LNCB74's potent tumor-killing activity and favorable safety profile. In December 2024, NextCure announced that the FDA accepted the Investigational New Drug (IND) application for LNCB74, clearing the way for the initiation of a Phase 1 clinical trial to evaluate the ADC in patients with various B7-H4-expressing cancers.
In addition to LNCB74, NextCure has two other clinical-stage oncology programs - NC410 and NC525 - as well as preclinical non-oncology programs targeting Siglec-15 (NC605) and ApoE4 (NC181) for the treatment of chronic bone diseases and Alzheimer's disease, respectively. The company is actively seeking partners or third-party financing to advance these non-core programs.
Financials and Liquidity
As of December 31, 2024, NextCure had cash, cash equivalents, and marketable securities of $68.6 million, which the company expects will fund its operations into the second half of 2026. For the full year 2024, the company reported no revenue and a net loss of $55.7 million, compared to a net loss of $62.7 million in 2023.
NextCure's cash burn has been significant as it advances its pipeline, with annual operating cash outflows of $40.8 million in 2024 and $53.0 million in 2023. The company's free cash flow was negative $41.3 million in 2024 and negative $53.8 million in 2023. To bolster its liquidity, NextCure entered into an at-the-market (ATM) sales agreement in August 2023, under which it sold 17,150 shares for net proceeds of approximately $39,000 during 2024.
The company's research and development expenses decreased from $47.9 million in 2023 to $41.5 million in 2024, while general and administrative expenses also declined from $19.7 million to $15.7 million over the same period. These reductions reflect the company's efforts to streamline operations and focus resources on its lead programs.
NextCure's financial position remains relatively strong, with a debt-to-equity ratio of 0.09 and both current and quick ratios of 7.50 as of December 31, 2024. The company operates exclusively in the United States and does not have any disclosed available credit lines.
Risks and Challenges
As a clinical-stage biopharmaceutical company, NextCure faces several risks and challenges common to the industry. These include the inherent uncertainty of drug development, the potential for delays or failures in clinical trials, the need for substantial additional financing to fund operations, and intense competition from other biotechnology and pharmaceutical companies.
Specifically, the success of NextCure's lead program, LNCB74, will be critical to the company's future. Failure to successfully develop and obtain regulatory approval for LNCB74 could significantly impair NextCure's prospects. Additionally, the company's reliance on partnerships and collaborations, such as the agreement with LigaChem Biosciences, introduces risks related to the execution and success of these arrangements.
Furthermore, NextCure's limited operating history, lack of revenue-generating products, and history of significant losses raise substantial doubt about the company's ability to continue as a going concern. The company's ability to access additional capital on favorable terms, if needed, will be crucial to its long-term survival and success.
Product Segments and Pipeline
NextCure's product pipeline is divided into two main segments: oncology and non-oncology.
Oncology Segment The oncology segment is NextCure's primary focus, with LNCB74 as the lead product candidate. LNCB74 is a state-of-the-art antibody-drug conjugate targeting the B7-H4 protein, which is expressed on multiple tumor types, including breast, ovarian, and endometrial cancers. This represents a significant market opportunity for the company.
In January 2025, NextCure began dosing patients in the Phase 1 clinical trial for LNCB74. The company is currently in cohort 2 of the dose escalation portion, enrolling patients with various tumor types. NextCure plans to initiate backfill cohorts for the Phase 1 trial in the second half of 2025.
Other clinical-stage oncology programs include NC410, a fusion protein designed to block immune suppression mediated by the LAIR-1 protein, and NC525, a novel LAIR-1 antibody that selectively targets acute myeloid leukemia (AML) blast cells and leukemic stem cells. NextCure is seeking partners to advance these programs.
Non-Oncology Segment The non-oncology pipeline consists of two preclinical programs: NC181 and NC605. NC181 is a humanized antibody targeting ApoE4 for the treatment of Alzheimer's disease, while NC605 is an antibody targeting Siglec-15 for the treatment of osteogenesis imperfecta and other chronic bone diseases. NextCure is pursuing partnerships or third-party financing to advance these preclinical non-oncology programs.
Outlook and Catalysts
In 2024, NextCure prioritized the development of LNCB74, pausing its internal manufacturing operations and reducing its workforce to conserve resources. The company expects its current cash position to fund operations into the second half of 2026.
Key upcoming milestones for NextCure include:
- Completion of the Phase 1 dose escalation study for LNCB74 and initiation of expansion cohorts in the second half of 2025 - Presentation of additional data from the Phase 1b study of NC410 in combination with pembrolizumab at upcoming medical conferences - Securing partnerships or third-party financing to advance the company's non-core programs, including NC605 and NC181
The successful advancement of LNCB74 through clinical development and regulatory approval would be a significant catalyst for NextCure, as the B7-H4-targeting ADC represents a substantial market opportunity in multiple solid tumor indications. However, the inherent risks and uncertainties of drug development, as well as the company's limited financial resources, pose significant challenges that NextCure must navigate in the coming years.
Conclusion
NextCure is a clinical-stage biopharmaceutical company focused on developing innovative cancer therapies, with its lead asset LNCB74, a B7-H4-targeting ADC, currently in Phase 1 clinical trials. The company's diverse pipeline and collaborative partnerships demonstrate its commitment to advancing novel treatments for cancer patients. However, NextCure faces substantial risks and financial constraints that will require careful navigation and execution to achieve long-term success. Investors should closely monitor the company's progress with LNCB74 and its ability to secure the necessary resources to advance its broader pipeline.