BELTSVILLE, Md., Nov. 20, 2025 (GLOBE NEWSWIRE) -- 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 announced that it will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference in New York City on Wednesday, December 3rd, at 11:00 am ET. A live audio webcast will be available through the Investors section of the company’s website at www.nex ...

Core Points - NextCure, Inc. has successfully closed a private placement in public equity (PIPE) with total gross proceeds of approximately $21.5 million [1][8] - The PIPE was led by Ikarian Capital, Squadron Capital Management, Affinity Healthcare Fund, LP, and Exome Asset Management, with participation from other healthcare-focused funds [1][8] - NextCure sold 708,428 shares of common stock at a market price of $8.52 per share and pre-funded warrants to purchase up to 1,815,049 shares at a price of $8.519 per warrant [2] - The net proceeds from the offering will be used for general working capital needs, extending the company's cash runway into the first half of 2027, beyond the planned first half of 2026 [3][8] - H.C. Wainwright & Co. acted as the exclusive placement agent for the offering [3] Company Overview - NextCure is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer patients who do not respond to or have disease progression on current therapies [6] - The company specializes in targeted therapies, including antibody-drug conjugates, leveraging its strengths in understanding biological pathways and biomarkers [6]

Core Points - NextCure, Inc. has entered into definitive agreements for a private placement of 2,523,477 shares of common stock at a price of $8.52 per share, expected to close on or about November 13, 2025 [1][3] - The gross proceeds from the offering are anticipated to be approximately $21.5 million, which will extend the company's cash runway into the first half of 2027 [3] - The net proceeds will be used for general working capital needs and to support proof of concept data readouts for two antibody drug conjugate programs, SIM0505 and LNCB74 [3][6] Company Overview - NextCure is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer patients who do not respond to existing treatments [6] - The company specializes in targeted therapies, including antibody-drug conjugates, leveraging its expertise in biological pathways and biomarkers [6]

Core Viewpoint - NextCure, Inc. (NXTC) has seen a significant stock price increase of 33.9% over the past four weeks, closing at $8.5, with analysts suggesting a potential upside based on price targets, indicating a mean estimate of $17.67, which represents a 107.9% upside potential [1][11]. Price Targets and Analyst Estimates - The mean estimate for NXTC comprises three short-term price targets with a standard deviation of $2.52, where the lowest estimate of $15.00 suggests a 76.5% increase, and the highest estimate of $20.00 indicates a 135.3% increase from the current price [2][9]. - A low standard deviation among price targets suggests a strong agreement among analysts regarding the stock's price movement direction, which can serve as a starting point for further research [9][10]. Earnings Estimates and Analyst Sentiment - Analysts have shown increasing optimism about NXTC's earnings prospects, as evidenced by a strong consensus in revising EPS estimates higher, which correlates with potential stock price movements [11][12]. - The Zacks Consensus Estimate for NXTC's current year has increased by 1.5% over the past month, with no negative revisions, indicating positive sentiment among analysts [12][13]. Zacks Rank and Investment Potential - NXTC holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, which further supports the stock's potential upside in the near term [13][14].

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].

Financial Performance - NextCure reported a net loss of $8.6 million for Q3 2025, a decrease from a net loss of $11.5 million in Q3 2024, reflecting lower research and development and general administrative costs[9]. - Research and development expenses were $6.1 million for Q3 2025, down from $8.8 million in Q3 2024, primarily due to reduced costs related to deprioritized programs[9]. - General and administrative expenses were $2.8 million for Q3 2025, down from $3.7 million in Q3 2024, mainly due to lower personnel costs[9]. Cash and Assets - Cash, cash equivalents, and marketable securities decreased to $29.1 million as of September 30, 2025, from $68.6 million as of December 31, 2024, a decline of $39.5 million[9]. - Total assets decreased to $39.6 million as of September 30, 2025, from $80.9 million as of December 31, 2024[14]. - Total stockholders' equity fell to $23.6 million as of September 30, 2025, compared to $65.5 million as of December 31, 2024[14]. Future Outlook - The company expects its current financial resources to be sufficient to fund operations into mid-2026[9]. - Proof of concept data readouts for SIM0505 and LNCB74 are expected in the first half of 2026[2]. Clinical Development - NextCure initiated U.S. enrollment in the Phase 1 trial for SIM0505 in October 2025, with plans to advance into higher-dose cohorts shortly[2]. - The FDA accepted a protocol amendment for LNCB74, allowing the addition of higher dose escalation cohorts[9].

Core Insights - NextCure, Inc. is advancing its antibody-drug conjugate (ADC) programs, particularly SIM0505 and LNCB74, with significant progress in clinical trials and FDA approvals [2][3][4]. Business Highlights and Near-Term Milestones - The company has initiated U.S. enrollment in the Phase 1 trial for SIM0505, a CDH6-targeting ADC, at a mid-tier dose range where multiple clinical responses were previously observed in China [2][3]. - FDA clearance was received for a protocol amendment for LNCB74, allowing for higher dose escalation cohorts [2][4]. - Proof of concept data readouts for both SIM0505 and LNCB74 are expected in the first half of 2026 [2][4]. Financial Results for Quarter Ended September 30, 2025 - Cash, cash equivalents, and marketable securities decreased to $29.1 million from $68.6 million as of December 31, 2024, primarily due to operational funding and a $12.0 million upfront license fee to Simcere Zaiming [5][10]. - Research and development expenses were $6.1 million, down from $8.8 million in the same quarter of 2024, attributed to lower costs from deprioritized programs and reduced personnel-related costs [5][10]. - General and administrative expenses decreased to $2.8 million from $3.7 million year-over-year, mainly due to lower personnel costs [5][10]. - The net loss for the quarter was $8.6 million, an improvement from a net loss of $11.5 million in the same quarter of 2024 [5][10]. Selected Financial Information - Total assets as of September 30, 2025, were $39.6 million, down from $80.9 million as of December 31, 2024 [11]. - Total stockholders' equity decreased to $23.6 million from $65.5 million [11].

Core Insights - NextCure, Inc. and Simcere Zaiming have initiated the dosing of the first patient in the U.S. for the Phase 1 trial of SIM0505, an antibody drug conjugate targeting advanced solid tumors [1][3] Company Overview - NextCure is a clinical-stage biopharmaceutical company focused on developing innovative cancer therapies, particularly for patients who do not respond to existing treatments [4] - Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group, is dedicated to creating groundbreaking therapies for cancer patients globally, with a strong R&D pipeline [5] Product Development - SIM0505 is designed as a novel antibody drug conjugate targeting cadherin-6 (CDH6) and includes a proprietary topoisomerase 1 inhibitor payload, aiming for broad anti-tumor activity and improved therapeutic potential [2] - The ongoing Phase 1 trial has expanded to include U.S. patients, with dose escalation currently progressing in China [2] Clinical Trial Progress - The first patient in the U.S. has been dosed at a mid-tier level where clinical responses have been observed, marking a significant milestone in the global development of SIM0505 [3][7] - The trial aims to accelerate the timeline for proof-of-concept data, expected in the first half of 2026 [7]

Summary of NextCure Conference Call Company Overview - NextCure is a biotechnology company focused on oncology, particularly women's health and other tumor indications, with two key pipeline assets: B7H4 and CDH6 antibody-drug conjugates (ADCs) [1][2] Key Pipeline Assets - **B7H4 ADC**: - In collaboration with LigaChemBio, currently in phase one clinical development with initial proof-of-concept readouts expected in the first half of next year [1][2] - Targets overexpressed B7H4 in ovarian, endometrial, and breast cancers [3][4] - Utilizes a unique beta-glucuronidase linker system for greater specificity and reduced off-target toxicity [4][6] - **CDH6 ADC**: - Recently licensed from Simcere Zaiming, also in phase one clinical development with readouts expected in the first half of next year [2][14] - Targets CDH6, which is overexpressed in ovarian and endometrial cancers, providing potential synergies with the B7H4 program [14][15] Competitive Landscape - The B7H4 ADC space is competitive, with notable players including AstraZeneca and Pfizer [5][6] - AstraZeneca's recent positive data and Pfizer's discontinuation of their B7H4 ADC were discussed [5][6] - NextCure aims to differentiate through a high-affinity antibody, unique linker system, and distinct payloads [7][8] Clinical Development Strategy - The company employs immunohistochemistry to select patients with high B7H4 expression for clinical trials, aiming to maximize response rates [8][9] - Currently in the fourth dose cohort of the phase one trial, with no dose-limiting toxicities (DLTs) reported [10][11] - Plans to lock in a dose based on pharmacokinetic data and backfill patient populations for further trials [10][11] Expected Outcomes and Milestones - Aiming for a minimum overall response rate of 25% for the B7H4 ADC, with hopes for higher efficacy [12][13] - Initial phase one data updates expected before year-end, with more detailed data anticipated in the first half of 2026 [11][12] - Two significant catalysts are anticipated in the first half of next year, focusing on proof-of-concept outcomes for both ADCs [29] Collaboration and Licensing - The licensing agreement with Simcere Zaiming includes a $12 million upfront payment and shared clinical development responsibilities [17][19] - Simcere is also providing drugs free of charge for the U.S. phase one trial and has made a $2 million equity investment in NextCure [19] Future Directions - NextCure is exploring the potential for combination therapies and sequencing strategies for ADCs to combat tumor resistance [26][27] - The company has multiple prioritized targets for future development, leveraging its expertise in immuno-oncology [27][28] Conclusion - NextCure is positioned to advance its innovative ADC programs in a competitive oncology landscape, with a focus on safety and efficacy, while leveraging strategic partnerships for growth and development [29][30]

Core Insights - NextCure, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer treatment, particularly for patients who do not respond to existing therapies [3]. Company Participation - NextCure will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference in New York City on September 8 at 4:00 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 targeted therapies, including antibody-drug conjugates, and aims to advance treatments by leveraging its expertise in biological pathways and biomarkers [3].