LeonaBio, Inc.
Key statistics
from XBRL data in SEC filingsAI briefing
from the latest 10-K, 10-Q and 8-K eventsLeonaBio, Inc. is a clinical-stage biopharmaceutical company advancing late-stage drug candidates for treatment-resistant metastatic breast cancer and ALS.
What they do
LeonaBio is developing lasofoxifene, a selective estrogen receptor modulator (SERM), in a registrational Phase 3 trial (ELAINE-3) for ESR1-mutated metastatic breast cancer, and ATH-1105, a small-molecule HGF system modulator, in Phase 2-ready development for ALS. The company also explores ATH-1020 and early discovery programs targeting neurological diseases.
Revenue drivers
- Lasofoxifene — Potential treatment for ESR1-mutated metastatic breast cancer; not yet commercialized, no revenue, but represents a multi-billion-dollar opportunity per management.
- ATH-1105 — Phase 2-ready candidate for ALS; not yet commercialized, no revenue, but in-licensed and internally developed pipeline.
Recent performance
Net losses have been persistent: $-106.0M in 2025, $-97.0M in 2024, and $-117.7M in 2023. Diluted EPS improved from $-25.19 in 2024 to $-24.7 in 2025. Operating cash flow improved to $-45.7M in 2025 from $-97.2M in 2024. As of June 30, 2026, cash and equivalents stood at $32.3M against total assets of $56.9M and equity of $33.6M.
Strategy
LeonaBio is focused on advancing lasofoxifene through the Phase 3 ELAINE-3 trial and preparing ATH-1105 for a Phase 2 proof-of-concept study in ALS. Management is pursuing disciplined clinical execution, including a planned protocol amendment to increase ELAINE-3 sample size from 500 to up to 600 participants. The company is leveraging its December 2025 financing of $90 million, with potential additional $146 million from warrant exercises, to fund milestones.
Risks
- Clinical trial failure risk — Lasofoxifene and ATH-1105 have limited clinical data, and future trials may not show safety or efficacy.
- Financing risk — Company has no revenue and has incurred annual net losses exceeding $90M for the last five years, requiring additional funding.
- Regulatory and approval risk — Lasofoxifene is not approved in any market, and regulatory approval in the U.S. is uncertain.
- Competition risk — Competing therapies for breast cancer and ALS may become available and reduce market opportunity.
Outlook
Management expects to complete enrollment in the Phase 3 ELAINE-3 trial in Q4 2026, with topline data in 2H 2027. ATH-1105 is on track to initiate a Phase 2 proof-of-concept study in ALS patients in 2H 2026. The company also expects to benefit from recent board appointments and nonclinical data supporting lasofoxifene's bone protective profile.