On August 1, 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 provided second-quarter 2024 financial results (Press release, NextCure, AUG 1, 2024, View Source [SID1234645267]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Following the release of Phase 1b data for the combination of NC410 and pembrolizumab at ASCO (Free ASCO Whitepaper), we have completed enrollment of additional ovarian cancer patients, and we look forward to sharing results from the expanded ovarian cohort later this year," said Michael Richman, president and CEO of NextCure. "We also continue to make important progress with our promising B7-H4 antibody-drug conjugate program, LNCB74, including the completion of GLP toxicology studies in July. We remain on track to submit an IND filing by year-end and rapidly advance into clinical development. NextCure is well capitalized to continue executing on our strategic priorities, with cash reserves expected to fund operations into the second half of 2026."

Business Highlights and Near-Term Milestones

NC410 (LAIR-2 fusion)

● Completed enrollment in June 2024 of an additional 16 ovarian cancer patients among the 100 mg and 200 mg cohorts of the Phase 1b portion of a Phase 1b/2 study evaluating NC410 in combination with pembrolizumab (pembro) in colorectal cancer (CRC) and ovarian cancer patients.
● Clinical data from the Phase 1b portion of the trial was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2024.
● On track to present data from ongoing ovarian cancer cohort expansion along with an update on the CRC data in the fourth quarter of 2024.

LNCB74 (B7-H4 ADC)

● Recently completed GLP toxicology studies.
● Presented a poster highlighting strong safety and pharmacokinetic profiles for LNCB74 at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
● Planned submission of an Investigational New Drug (IND) application by year-end.
NC181 (APOE4)

● Presented "NC181: First-in-class Approach to Treat Alzheimer’s Disease" at the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference.
● Initiated manufacturing of material for toxicology studies.
● Seeking partnering or other funding sources with the potential to file an IND mid-2025.

NC605 (Siglec-15)

● Conducted FDA pre-IND meeting related to treating osteogenesis imperfecta.
● Toxicology studies are ongoing; seeking partnering or other funding sources with the potential to file an IND in the second half of 2025.

Financial Results for Quarter Ended June 30, 2024

● Cash, cash equivalents, and marketable securities as of June 30, 2024 were $86.4 million as compared to $108.3 million as of December 31, 2023. The decrease of $21.9 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 $12.4 million for the three months ended June 30, 2024, as compared to $13.4 million for the three months ended June 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 $4.1 million for the three months ended June 30, 2024, as compared to $5.7 million for the three months ended June 30, 2023. The decrease of $1.6 million was primarily related to payroll, lower stock compensation expense, lower professional fees and lower insurance costs.
● Net loss was $15.4 million for the three months ended June 30, 2024, as compared to a net loss of $17.9 million for the three months ended June 30, 2023.