Nuvalent Inc

Latest Results (14.05.2026):

Nuvalent, Inc. reported fourth quarter 2025 financial results: cash, cash equivalents and marketable securities of $1.372 billion as of December 31, 2025; Q4 R&D expense $67.8 million (FY 2025 $307.0 million); Q4 G&A expense $34.4 million (FY 2025 $107.3 million); net loss $118.7 million for Q4 2025 (FY 2025 net loss $425.4 million) and basic/diluted net loss per share of $1.58 for Q4 2025 ($5.85 for FY 2025). The company reiterated a cash runway into 2029 and highlighted regulatory and clinical milestones, including an FDA acceptance of the zidesamtinib NDA with a PDUFA date of September 18, 2026.

Cash & Runway

Cash, cash equivalents and marketable securities totaled $1,371.95 million at December 31, 2025; management expects existing cash to fund operations into 2029.

R&D and G&A

Research & development expense was $67.8 million in Q4 2025 and $306.97 million for FY 2025. General & administrative expense was $34.4 million in Q4 2025 and $107.34 million for FY 2025, reflecting increased operating costs year‑over‑year.

Net Loss & EPS

Nuvalent reported a Q4 2025 net loss of $118.705 million (FY 2025 net loss $425.377 million). Net loss per share was $(1.58) for Q4 2025 and $(5.85) for FY 2025; weighted average diluted shares outstanding were ~75.12 million for the quarter.

Regulatory Progress

The FDA accepted the NDA for zidesamtinib for ROS1-positive NSCLC in TKI pre-treated patients and set a PDUFA action date of September 18, 2026; Nuvalent anticipates a potential U.S. launch in 2026 pending approval.

Planned Submissions & Trials

Nuvalent plans an NDA submission for neladalkib in ALK‑positive, TKI pre‑treated NSCLC in H1 2026 after a completed pre‑NDA meeting; Phase 3 ALKAZAR (TKI‑naïve) and HEROEX‑1 (HER2 program) enrollment remain ongoing through 2026.

Financing

Nuvalent completed an underwritten public offering on November 20, 2025, raising approximately $500.0 million in gross proceeds from the sale of 4.95 million shares at $101.00 per share.

Balance Sheet Snapshot

Selected year‑end 2025 balance sheet items: working capital $1,301.26 million; total assets $1,412.71 million; total liabilities $164.37 million; total stockholders' equity $1,248.34 million.

Non‑operating Items

Total other expense, net reflected a Q4 2025 charge driven in part by a $27.94 million decrease in the fair value of a related party revenue share liability; total other expense, net was $(16.33) million for Q4 2025 and $(10.49) million for FY 2025.