Atossa Q2 operating expenses $9M; FDA clears IND path for (Z)-endoxifen in metastatic breast cancer

ATOSSA THERAPEUTICS, INC.

2025-Q2 EPS reported -$0.12

Total operating expenses $9.0M in Q2 2025, up 27% YoY from $7.1M; R&D spend rose 55% to $5.5M.
FDA feedback July 2025: no additional toxicity studies needed; Atossa plans IND submission in Q4 2025 for (Z)-endoxifen in metastatic breast cancer.
I-SPY2 pilot (20 patients): 95% completed ≥75% dosing; median Ki-67 dropped from 10.5% to 5%; functional tumor volume decreased 77.7% by MRI.
Issued U.S. Patent 12,281,056 with 58 claims covering (Z)-endoxifen enteric formulations; two other patents under post-grant challenge.

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