LeonaBio files amended 8-K on Sermonix license, provides ELAINE-3 cost and timeline update

LeonaBio, Inc.

SEC granted waiver from providing Sermonix financial statements; license deal treated as business acquisition under Regulation S-X.
Sermonix reported ELAINE-3 cash expenditures of $14M (2023), $12M (2024), $5M (2025 through Dec 18).
LeonaBio expects $45M (2026) and $30M (2027) in ELAINE-3 cash spend; made ~$11M from Dec 18–31, 2025.
ELAINE-3 protocol amended to increase sample size from 500 to up to 600; enrollment completion targeted Q4 2026, topline data H2 2027.
License agreement grants LeonaBio exclusive rights to lasofoxifene for oncology outside Retained Territory.

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