On November 7, 2024 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, reported a business update and announced third-quarter 2024 financial results (Press release, NextCure, NOV 7, 2024, View Source [SID1234647939]).

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"The November SITC (Free SITC Whitepaper) presentation of LNCB74 preclinical data will highlight the differentiation of our B7-H4 ADC from other ADC’s that also target B7-H4. We plan to file an IND in the fourth quarter of this year and advance into Phase 1, shortly following receipt of an FDA safe-to-proceed letter," said Michael Richman, NextCure’s president and CEO. "Additionally, while the NC410 combo has shown encouraging Phase 1b clinical activity in both ovarian cancer and CRC patients, we plan to conclude the current trial and seek a partner to advance the program, allowing us to focus our resources on advancing the development of LNCB74."

Business Highlights and Near-Term Milestones

LNCB74 (B7-H4 ADC)

● Leveraging LigaChem Biosciences, Inc. glucuronidase cleavable site-specific linkage as part of a collaboration agreement that includes a 50-50 cost sharing of external development expenses and certain internal cost sharing associated with the development of the antibody- drug conjugate (ADC) program.
● Preclinical data from LNCB74 (B7-H4 ADC) will be presented at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in November.
● Planned submission of an Investigational New Drug (IND) application in the fourth quarter of this year.

NC410 (LAIR-2 fusion)

● Additional colorectal cancer (CRC) patient Phase 1b clinical data along with biomarker data supporting mechanism of action to be presented at SITC (Free SITC Whitepaper) annual meeting in November.
● As of October 14, 2024 (the cut-off date), 11 patients (4 with ovarian cancer and 7 with CRC) remain in the Phase 1b study evaluating NC410 in combination with pembrolizumab and will continue to be monitored while the study concludes.
● As of the cut-off date, the response rate for the ovarian cancer patients that were immune checkpoint inhibitor (ICI) naïve was 25% based on 5 out of 20 patients, which consisted of 2 partial responses (PRs) at 200 mg, and 3 PRs at 100mg in ICI naïve.
● As of the cut-off date, the 100 mg cohort CRC response rate was 8.3% based on 3 out of 36 patients, which consisted of 3 PRs in ICI naïve, MSS/microsatellite instability-low with a disease control rate (DCR) of 47% (17/36), median disease control (mDC) duration of 8.5 months, and median duration of response of 15.2 months. A 200 mg CRC cohort of 7 showed no clinical responses with a DCR of 86% (6/7) and a mDC duration of 8.3 months.
● Will seek a partner or pursue third party financing to advance NC410 in further clinical trials.

Preclinical Non-Oncology Programs Seeking a Partner or Third Party Financing

● NC181 (ApoE4), a humanized antibody for the treatment of Alzheimer’s disease (AD). In preclinical AD animal models, NC181 has demonstrated amyloid clearance, prevention of amyloid deposition, plaque clearance and reduced neuroinflammation.
● NC605 (Siglec-15), a humanized antibody for the treatment of osteogenesis Imperfecta (OI). Preclinical data reported that NC605 treatment reduced bone loss and enhanced bone quality in mice with OI.
● Both programs could lead to IND filings within 12 to 18 months if financial support from a partner or third parties is secured.

Financial Results for Quarter Ended September 30, 2024

● Cash, cash equivalents, and marketable securities as of September 30, 2024 were $75.3 million as compared to $108.3 million as of December 31, 2023. The decrease of $33.0 million was primarily due to cash used to fund operations. NextCure expects financial resources to fund operating expenses and capital expenditures into the second half of 2026.
● Research and development expenses were $8.8 million for the three months ended September 30, 2024, as compared to $11.0 million for the three months ended September 30, 2023. Net costs on the LNCB74 program were more than offset by lower costs on other programs and preclinical development and lower personnel-related costs.
● General and administrative expenses were $3.7 million for the three months ended September 30, 2024, as compared to $4.6 million for the three months ended September 30, 2023. The decrease of $0.9 million was primarily related to lower payroll, lower stock compensation expense and lower insurance costs.
● Net loss was $11.5 million for the three months ended September 30, 2024, as compared to a net loss of $14.3 million for the three months ended September 30, 2023.