LeonaBio (LONA) Q4 2025 earnings summary

Executive summary

• Acquired exclusive global license (excluding Asia and certain Middle East countries) for lasofoxifene, a late-stage SERM targeting metastatic breast cancer with ESR1 mutations.

• Raised $90 million in private placement financing, with warrants potentially providing up to $146 million more to support clinical development.

• Transitioned from Athira Pharma to LeonaBio, reflecting a strategic shift to a focused, diversified biopharma company with two clinical-stage programs.

• Advanced lasofoxifene into a Phase 3 trial and ATH-1105 into Phase 1, with plans for a Phase 2 ALS study in 2H 2026.

Financial highlights

• Cash, cash equivalents, and investments totaled $88.3 million as of December 31, 2025, up from $51.3 million at year-end 2024.

• Net loss was $105.6 million ($24.70 per share) for 2025, compared to $96.9 million ($25.19 per share) in 2024.

• R&D expenses rose to $85.6 million in 2025 from $70.7 million in 2024, mainly due to acquired in-process R&D for lasofoxifene.

• G&A expenses decreased to $16.7 million in 2025 from $26.1 million in 2024, reflecting cost efficiencies.

• Net cash used in operations was $45.7 million in 2025, down from $97.2 million in 2024.

Outlook and guidance

• Enrollment for the Phase 3 ELAINE-3 trial of lasofoxifene expected to complete in 4Q 2026, with topline data anticipated in 2H 2027.

• Phase 2 proof-of-concept study of ATH-1105 in ALS patients planned to initiate in 2H 2026.