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]

BELTSVILLE, Md., Oct. 04, 2024 (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 two presentations at the Society for Immunotherapy of Cancer (SITC) annual meeting, to be held in Houston, TX from November 6-10, 2024. NextCure will share pre-clinical data from LNCB74 (B7-H4 ADC) and biomarker data from NC410 combination study with pembrolizumab ...

Of the 20 evaluable ovarian cancer patients, there were 5 PRs Of the 43 evaluable ICI-naïve MSS/MSI-L CRC patients without liver metastasis, there were 3 PRs Biomarker data support proposed mechanism of action of NC410 BELTSVILLE, Md., Sept. 16, 2024 (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 clinical data from the Phase 1b portion ...

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 June 30, 2024 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) Delaware 47-5231247 (State or ot ...

Exhibit 99.1 Next@ure NextCure Provides Business Update and Reports Second Quarter 2024 Financial Results – LNCB74 (B7-H4 ADC) GLP tox studies completed and targeting an IND application by year-end – NC410 combo with pembrolizumab ovarian cohort enrollment completed – Cash of approximately $86.4 million expected to fund operations into second half of 2026 BELTSVILLE, Md. – August 1, 2024 – NextCure, Inc. (Nasdaq: NXTC), a clinicalstage biopharmaceutical company committed to discovering and developing novel, ...

About NextCure, Inc. Investor Inquiries Timothy Mayer, Ph.D. NextCure, Inc. Chief Operating Officer (240) 762-6486 IR@nextcure.com A recording of the webcast will be available on the conference day starting at 7 AM ET through the Investors section of the company's website at www.nextcure.com. The webcast will be available on the website for 30 days. Cautionary Statement Regarding Forward-Looking Statements BELTSVILLE, Md., June 20, 2024 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage bio ...

A recording of the webcast will be available on the conference day starting at 7 AM ET through the Investors section of the company's website at www.nextcure.com. The webcast will be available on the website for 30 days. NextCure, Inc. is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies in cancer, including NC410, a LAIR-2 fusion protein, and LNCB74, a novel ADC targeting B7-H4. The Company also has a non-oncology preclinica ...

Of the evaluable ICI-naïve MSS/MSI-L CRC patients without liver metastasis, there were 2 confirmed ongoing PRs and a disease control rate of 51% Of the 7 evaluable ovarian cancer patients, there were 3 PRs and a disease control rate of 43% Data to be presented June 1, 2024, 9:00 am-12:00 pm CT BELTSVILLE, Md., May 30, 2024 (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 ...