LeonaBio reports Q2 2026 results, enrollment nears completion for ELAINE-3 trial

LeonaBio, Inc. reported financial results for the quarter ended June 30, 2026, on August 14, 2026, alongside a pipeline update on its lead breast cancer candidate lasofoxifene.

CEO Mark Litton said the company has enrolled 495 patients and remains on track to complete enrollment of ELAINE-3 in the fourth quarter of 2026, with topline data expected in the second half of 2027.¹ The trial is testing lasofoxifene in combination with abemaciclib, a CDK4/6 inhibitor, as a targeted therapy for patients with estrogen receptor-positive, HER2-negative, ESR1-mutated metastatic breast cancer who have progressed after treatment with aromatase inhibitors and CDK4/6 inhibitors.¹ The primary endpoint is a statistically significant improvement in progression free survival, as assessed by blinded, independent central review.¹ Overall, the company expects to complete enrollment of roughly 600 participants in ELAINE-3 during the fourth quarter of 2026, with topline data anticipated in the second half of 2027.¹

On the balance sheet, cash, cash equivalents and investments totaled $51.1 million as of June 30, 2026, down from $88.3 million at the end of 2025.¹ Net cash used in operations rose to $37.9 million for the quarter, compared with $21.7 million in the same period a year earlier.¹ R&D expenses climbed to $12.9 million from $3.7 million a year prior, driven largely by ELAINE-3 trial costs.¹ G&A expenses rose to $6.6 million from $3.6 million.¹ Net loss for the quarter was $19.0 million, or $0.80 per share, compared with a $7.0 million loss, or $1.78 per share, a year earlier.¹

The company also noted board changes, with three new directors joining in May 2026 and longtime board member John Fluke, Jr. retiring.