NextCure(NXTC)

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NextCure(NXTC) - 2025 Q1 - Quarterly Report
2025-05-01 20:25
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-38905 NextCure, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of ...
NextCure(NXTC) - 2025 Q1 - Quarterly Results
2025-05-01 20:15
Exhibit 99.1 NextCure Provides Business Update and Reports First Quarter 2025 Financial Results BELTSVILLE, Md. – May 1, 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, 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 plan ...
NextCure Provides Business Update and Reports First Quarter 2025 Financial Results
GlobeNewswire· 2025-05-01 20:05
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 2025Plan to provide a proof of concept data readout in the first half of 2026Cash 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-clas ...
NextCure to Present at 24th Annual Needham Virtual Healthcare Conference
Newsfilter· 2025-04-04 11:00
Core Insights - NextCure, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer patients who do not respond to existing treatments [3] - The company will present at the 24th Annual Needham Virtual Healthcare Conference on April 10, 2025, at 8:45 am ET [1] Company Overview - NextCure specializes in creating first-in-class and best-in-class therapies using differentiated mechanisms of action, including antibody-drug conjugates [3] - The company aims to advance treatments by leveraging its expertise in biological pathways, biomarkers, and cell interactions within the tumor microenvironment [3] Event Details - A live audio webcast of the conference presentation will be available on the company's website, with a replay accessible for 30 days post-event [2]
NextCure(NXTC) - 2024 Q4 - Annual Report
2025-03-06 21:26
Financial Position - The company reported significant losses and has never generated revenue from product sales, indicating a challenging financial position [23] - The company anticipates requiring substantial additional financing to pursue its business objectives, which may not be available on acceptable terms [23] - The company has a history of significant losses and has never generated revenue from product sales, indicating a need for substantial additional financing to pursue business objectives [23] - The company has limited operating history and may never achieve or maintain profitability, which poses a risk to investors [23] Regulatory Risks - The regulatory approval processes for product candidates are lengthy and inherently unpredictable, posing risks to commercialization [23] - The company is studying product candidates in combination with other therapies, exposing it to additional regulatory risks [23] - Clinical development involves a lengthy and expensive process with uncertain outcomes, and the company has limited experience in designing and implementing clinical trials [23] Compliance and Listing Standards - The company is currently not in compliance with the continued listing standards of the Nasdaq Global Select Market, risking delisting [30] - The company is currently not in compliance with the continued listing standards of the Nasdaq Global Select Market, which could lead to delisting if compliance is not regained [30] Competitive Position - The company has filed patent applications but has obtained only a small number of patents, which may affect its competitive position [30] - The company faces significant competition from other biotechnology and pharmaceutical companies, which may impact its market position [30] - The company has filed patent applications for its product candidates but has obtained only a small number of patents to date, which may affect its ability to compete [30] Operational Challenges - The company relies on third-party suppliers for key materials, and any disruption could harm its business operations [25] - The company relies on third-party suppliers for key materials in its manufacturing process, and any loss of these suppliers could harm its business [25] - The company may encounter difficulties in enrolling patients for clinical trials due to external factors, affecting its development timelines [23] - The company may face difficulties in enrolling patients in clinical trials due to external factors such as pandemics [23] - The company is dependent on its ability to advance product candidates through preclinical studies and clinical trials, which is uncertain [23]
NextCure(NXTC) - 2024 Q4 - Annual Results
2025-03-06 21:15
Financial Performance - Full year 2024 net loss was $55.7 million, a decrease from a net loss of $62.7 million in 2023, representing a reduction of approximately 11%[10] - Loss from operations for 2024 was $59.7 million, compared to $67.6 million in 2023, indicating an improvement of approximately 11%[13] - General and administrative expenses decreased to $15.7 million in 2024 from $19.7 million in 2023, a reduction of about 20%[10] - Research and development expenses for 2024 were $41.5 million, down from $47.9 million in 2023, reflecting a decrease of about 13%[10] Cash and Assets - Cash, cash equivalents, and marketable securities as of December 31, 2024, were $68.6 million, down from $108.3 million as of December 31, 2023, a decrease of approximately 36.7%[10] - Total assets as of December 31, 2024, were $80.9 million, down from $128.0 million as of December 31, 2023[15] Clinical Development - The company completed cohort 1 of the Phase 1 trial of LNCB74 (B7-H4 ADC) in February 2025 and plans to initiate backfill cohorts in the second half of 2025[6] - The U.S. FDA accepted an Investigational New Drug (IND) application for LNCB74 in December 2024, with the first patient dosed in January 2025[7] Future Plans - The company aims to secure financial support for preclinical programs NC181 and NC605, potentially leading to IND filings within 12 to 18 months[10] - The company expects current financial resources to fund operations into the second half of 2026[6]
NextCure Provides Business Update and Reports Full Year 2024 Financial Results
GlobeNewswire· 2025-03-06 21:05
Core Insights - NextCure, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer treatment, reporting a business update and full-year financial results for 2024 [1][6]. Business Highlights and Near-Term Milestones - The company has reprioritized resources to advance its antibody-drug conjugate (ADC) program, specifically LNCB74, and completed cohort 1 of the Phase 1 study for multiple cancers [2][3]. - Plans to initiate backfill cohorts for LNCB74 in the second half of 2025 [2][8]. - Preclinical data for LNCB74 was presented at the Society of Immunotherapy of Cancer annual meeting in November 2024, showcasing its potential for multiple solid tumor indications [8]. Financial Results for Full Year Ended December 31, 2024 - Cash, cash equivalents, and marketable securities decreased to approximately $68.6 million from $108.3 million in 2023, primarily due to operational funding [7][13]. - Research and development expenses were $41.5 million, down from $47.9 million in 2023, while general and administrative expenses decreased to $15.7 million from $19.7 million [8][11]. - The net loss for 2024 was $55.7 million, an improvement from a net loss of $62.7 million in 2023, with a net loss per share of $1.99 compared to $2.25 in the previous year [11][12].
NextCure Announces First Patient Dosed in the Phase 1 Study of LNCB74 (B7-H4 ADC) as Therapeutic for Treating Multiple Cancers
GlobeNewswire· 2025-01-10 13:05
Core Insights - NextCure, Inc. has initiated the first patient dosing in its Phase 1 study of LNCB74, a B7-H4-targeting antibody-drug conjugate aimed at treating multiple cancers [1][2] - The company views this milestone as significant for advancing its B7-H4 ADC program and aims to establish the safety, tolerability, and preliminary anti-tumor activity of LNCB74 [2] - The U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug application for LNCB74 in December 2024, facilitating the commencement of this clinical trial [2] Company Overview - NextCure is a clinical-stage biopharmaceutical company focused on developing innovative cancer therapies for patients who do not respond to existing treatments [3] - The company employs differentiated mechanisms of action, including antibody-drug conjugates, antibodies, and proteins, to advance its therapeutic offerings [3] - NextCure collaborates with LigaChem Biosciences, Inc. for the development of LNCB74 under a co-development agreement [3]
NextCure to Participate in the 36th Annual Piper Sandler Healthcare Conference
GlobeNewswire News Room· 2024-11-26 12:00
Core Insights - NextCure, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer patients who do not respond to existing treatments or experience disease progression [3] Company Participation - NextCure will participate in a fireside chat at the 36th Annual Piper Sandler Healthcare Conference in New York City on December 5 at 12:00 pm ET [1] Webcast Information - A live audio webcast of the event will be available on the company's website, with a replay accessible for 30 days post-event [2] Company Overview - NextCure specializes in advancing therapies using differentiated mechanisms, including antibody-drug conjugates, antibodies, and proteins, targeting biological pathways and biomarkers relevant to cancer treatment [3]
Preclinical Data Demonstrates Anti-Siglec-15 Treatment Enhanced Generation of Quality Bone with Better Mechanical Properties in Mice with Moderate-to-Severe Osteogenesis Imperfecta
GlobeNewswire News Room· 2024-11-19 13:05
Core Insights - NextCure, Inc. presented preclinical data showing that NC605, an anti-Siglec-15 antibody, enhances bone quality and mechanical properties in a model of Osteogenesis Imperfecta (OI) [1][4] Group 1: Company Overview - NextCure is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer patients who do not respond to existing treatments [5] - The company utilizes differentiated mechanisms of action, including antibody-drug conjugates and proteins, to advance its therapeutic candidates [5] Group 2: Osteogenesis Imperfecta (OI) Insights - OI is characterized by high bone turnover, abnormal bone formation, and increased fragility, with no current cure available [2] - Existing treatments primarily inhibit bone loss but result in poor bone quality, whereas NC605 enhances osteoblast recruitment and improves bone quality [2] Group 3: Preclinical Data Findings - In a study with OI mice, 90% of treated male and 80% of treated female mice had no fractures, compared to 85% and 55% in control groups, respectively [3] - Treated mice exhibited increased trabecular and cortical tissue mineral density, leading to enhanced overall bone quality [3] - Specifically, treated male mice showed increased trabecular bone volume fraction and cortical thickness, resulting in improved mechanical strength measures [3][4]