LeonaBio (LONA) Q1 2026 earnings summary

Executive summary

• Focused on developing novel therapeutics for metastatic breast cancer and ALS, with lead assets lasofoxifene (Phase 3) and ATH-1105 (Phase 2 ready), and advanced the ELAINE-3 trial with enrollment completion expected in 4Q 2026 and topline data in 2H 2027.

• Initiated preparations for Phase 2 proof-of-concept study of ATH-1105 in ALS, targeting patient dosing in 2H 2026.

• Acquired rights to lasofoxifene in December 2025, diversifying the pipeline and leveraging late-stage clinical development expertise.

• Strengthened leadership with three new board appointments and hosted a virtual KOL event highlighting lasofoxifene's potential.

• No approved products or commercial revenue to date; operations funded primarily through equity financings.

Financial highlights

• Net loss for Q1 2026 was $32.9 million ($1.73 per share), up from $9.1 million ($2.34 per share) in Q1 2025, driven by increased R&D and a $16.3 million non-cash warrant revaluation.

• Operating expenses rose to $17.2 million from $9.5 million year-over-year, with R&D expenses increasing to $10.3 million, mainly due to ELAINE-3 trial costs.

• G&A expenses increased to $6.9 million in Q1 2026 from $5.2 million in Q1 2025, primarily from higher professional service fees.

• Cash, cash equivalents, and investments totaled $67.7 million as of March 31, 2026, down from $88.3 million at December 31, 2025.

• Cash used in operations was $20.9 million for Q1 2026, compared to $14.7 million in Q1 2025.

Outlook and guidance

• Current cash and investments expected to fund operations for at least 12 months from the reporting date.

• Substantial additional funding will be required to advance clinical programs and support ongoing operations.

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

• Phase 2 proof-of-concept trial for ATH-1105 in ALS patients on track to begin dosing in 2H 2026.

• Sufficient capital resources projected to advance both oncology and neurodegeneration programs.