On March 2, 2023 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, reported a business update and reported full year 2022 financial results (Press release, NextCure, MAR 2, 2023, View Source [SID1234628068]).
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"2023 is expected to be a significant year for NextCure as we are anticipating data updates on all three of our clinical programs, starting with NC410, which targets the extracellular matrix," said Michael Richman, NextCure’s president and chief executive officer. "Backed by a strong cash position, experienced team and integrated development capabilities, we are poised to execute on the continued advancement of our novel pipeline. With more than two years of expected financial runway, we believe we have the financial resources to deliver on our meaningful near-term milestones."
Business Highlights and Near-Term Milestones
NC410 (LAIR-2 fusion)
● Continued enrollment in the Phase 1b/2 clinical trial evaluating NC410 in combination with pembrolizumab in patients with immune checkpoint refractory or naïve solid tumors.
● Phase 1b update is expected in mid-2023.
NC762 (B7-H4 mAb)
● Continued enrollment in the Phase 1b dose expansion study in patients with solid tumors and high expression of B7-H4.
● Phase 1b update is expected in the fourth quarter of 2023.
NC525 (LAIR-1 mAb)
● Dosed first patient in a Phase 1 monotherapy dose escalation and safety study evaluating NC525 in AML patients in February 2023.
● Initial Phase 1a data is expected in the fourth quarter of 2023.
Financial Guidance
● NextCure expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditures into mid-2025.
Financial Results for Full Year Ended December 31, 2022
● Cash, cash equivalents, and marketable securities as of December 31, 2022, were $159.9 million as compared to $219.6 million as of December 31, 2021. The decrease of $59.7 million was primarily related to cash used to fund operations, cash used to purchase fixed assets, and changes in the fair value of our marketable securities.
● Research and development expenses were $54.2 million for the year ended December 31, 2022, as compared to $50.2 million for the year ended December 31, 2021. The increase of $4.0 million was primarily related to higher clinical and personnel costs, partially offset by lower research costs.
● General and administrative expenses were $21.7 million for the year ended December 31, 2022, as compared to $20.6 million for the year ended December 31, 2021. The increase of $1.1 million was primarily related to higher facility and personnel costs, partially offset by lower professional services costs.
● Net loss was $74.7 million for the year ended December 31, 2022, as compared with a net loss of $69.4 million for the year ended December 31, 2021. The change in net loss from the previous year was primarily due to higher research and development expenses.