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]

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]

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]

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].

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]

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]

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]

Financial Position - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities of $75.3 million, expected to fund operations into the second half of 2026[73]. - The accumulated deficit as of September 30, 2024, was $368.5 million, primarily due to research and development and general administrative expenses[75]. - Net cash used in operating activities was $33.8 million for the nine months ended September 30, 2024, compared to $42.3 million for the same period in 2023[103]. - Net cash provided by investing activities for the nine months ended September 30, 2024 was $48.3 million, primarily from sales and maturities of marketable securities[104]. - The company sold 17,151 shares of common stock for net proceeds of approximately $39,000 during the nine months ended September 30, 2024[100]. Loss and Expenses - The net loss for the three months ended September 30, 2024, was $11.5 million, compared to a net loss of $14.3 million for the same period in 2023, reflecting a decrease of $2.8 million[75]. - The net loss for the nine months ended September 30, 2024, was $44.1 million, compared to $48.3 million for the same period in 2023, a decrease of $4.2 million[88]. - Research and development expenses for the three months ended September 30, 2024, were $8.77 million, down from $11.01 million in 2023, a reduction of $2.24 million[88]. - Research and development expenses for the three months ended September 30, 2024 decreased by $2.2 million to $8.77 million compared to the same period in 2023[91]. - Total external research and development expenses for the nine months ended September 30, 2024 increased by $1.8 million to $20.01 million compared to the same period in 2023[92]. - General and administrative expenses for the three months ended September 30, 2024 decreased by $0.9 million to $X million compared to the same period in 2023[93]. - Restructuring and asset impairment charges were $2.5 million for the nine months ended September 30, 2024, including $0.7 million in severance charges and $1.8 million in asset impairment[94]. - Other income, net for the three months ended September 30, 2024 decreased by $0.4 million due to lower interest income[95]. Strategic Plans - The company plans to file an IND application for LNCB74 by year-end 2024 and advance into Phase 1 trials[70]. - The company is seeking partnerships for clinical programs NC525 and NC318, as well as for preclinical non-oncology programs, with potential IND filings within 12 to 18 months if funding is secured[72]. - Restructuring actions included pausing internal manufacturing operations and reducing workforce, aimed at aligning with a focused pipeline[73]. - The company expects to incur substantial expenditures in the foreseeable future as it advances LNCB74 through clinical development and regulatory approval[77]. - The company may seek to raise additional capital through equity sales, debt financings, and strategic alliances[102]. Capital Raised - The company raised approximately $423 million in gross proceeds from equity instruments since inception through September 30, 2024[75].

Financial Performance - As of September 30, 2024, cash, cash equivalents, and marketable securities totaled $75.3 million, down from $108.3 million at the end of 2023, reflecting a decrease of $33.0 million[7] - Research and development expenses for Q3 2024 were $8.8 million, a decrease from $11.0 million in Q3 2023, primarily due to lower costs on other programs[7] - General and administrative expenses decreased to $3.7 million in Q3 2024 from $4.6 million in Q3 2023, attributed to lower payroll and stock compensation expenses[7] - The net loss for Q3 2024 was $11.5 million, compared to a net loss of $14.3 million in Q3 2023, indicating an improvement in financial performance[7] - NextCure expects to fund operations into the second half of 2026 with current cash reserves[1] Clinical Development - NextCure plans to prioritize resources on LNCB74 (B7-H4 ADC) with an IND submission expected by year-end 2024[1] - The response rate for ICI naïve ovarian cancer patients in the NC410 study was 25%, with 5 out of 20 patients showing partial responses[5] - The disease control rate (DCR) for the 100 mg CRC cohort was 47% based on 36 patients, with a median disease control duration of 8.5 months[5] - NextCure is seeking a partner to advance the NC410 program following the conclusion of the current trial[2] - Preclinical data for LNCB74 will be presented at the SITC annual meeting in November 2024[3]

Core Insights - NextCure, Inc. reports promising preclinical data for LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC), and plans to file an Investigational New Drug (IND) application by year-end [1][2] - The company also presents biomarker data from the NC410 combination study with pembrolizumab for colorectal cancer patients [1] Preclinical Data on LNCB74 - LNCB74 is designed with a drug-to-antibody ratio of 4 (DAR4) and utilizes LigaChem Biosciences' ConjuAllTM technology for improved stability and selective payload release in tumor cells [2] - The ADC shows specific binding to B7-H4 expressing tumor cells, mediates potent cytotoxicity with sub-nanomolar to low nanomolar EC50 values, and demonstrates strong anti-tumor activity in various tumor models [3] - A single dose of 3 mg/kg resulted in durable tumor regression, indicating comparable or superior activity to existing B7-H4 targeting ADCs [3] - LNCB74 has favorable pharmacokinetics and stability in rodents and was well tolerated in cynomolgus monkeys at doses up to 10 mg/kg [3] Phase 1b Study of NC410 - The Phase 1b study evaluates NC410, a LAIR-2 fusion protein, in combination with pembrolizumab for ovarian cancer and ICI-naïve MSS/MSI-L colorectal cancer [4] - The combination shows clinical activity against MSS/MSI-L CRC, with subjects achieving partial responses or stable disease demonstrating meaningful durability [4] - Among 43 evaluable ICI-naïve MSS/MSI-L CRC patients, there were 3 partial responses, with disease control rates of 86% and 47% for 200 mg and 100 mg NC410 doses, respectively [5] Biomarker Data for NC410 - Biomarker data supports the proposed mechanism of action for NC410, indicating tumor microenvironment remodeling and enhanced immune infiltration [6] - Treatment with NC410 was well tolerated [6] Presentation Details - NextCure will present findings on LNCB74 and NC410 at the Society for Immunotherapy of Cancer (SITC) annual meeting on November 8 and 9, 2024 [7] Company Overview - NextCure is a clinical-stage biopharmaceutical company focused on developing innovative cancer therapies that target patients unresponsive to current treatments, utilizing differentiated mechanisms including ADCs and proteins [8]