LeonaBio beats Q2 loss forecast as Phase 3 ELAINE-3 trial advances

LeonaBio beats Q2 loss forecast as Phase 3 ELAINE-3 trial advances

Fiona Craig

Mon, August 17, 2026 at 3:26 PM GMT+3 2 min read

• LONA +1.21%

LeonaBio, Inc. (NASDAQ:LONA) reported a smaller-than-expected second-quarter loss on Monday as the clinical-stage biopharmaceutical company continued to advance its pivotal Phase 3 ELAINE-3 study of lasofoxifene.

The company posted a loss of $0.80 per share for the quarter, outperforming analyst expectations for a loss of $1.12 per share. LeonaBio shares were unchanged in after-hours trading following the results.

Net loss nevertheless widened substantially to $19.0 million for the three months ended June 30, 2026, compared with $7.0 million in the corresponding quarter last year.

ELAINE-3 enrolment approaches 600-patient target

LeonaBio remains on schedule to complete enrolment of approximately 600 participants in its Phase 3 ELAINE-3 clinical trial during the fourth quarter of 2026.

As of the end of the second quarter, 495 patients had joined the study, with topline results expected during the second half of 2027.

ELAINE-3 is evaluating lasofoxifene in combination with abemaciclib as a potential treatment for patients with estrogen receptor-positive, HER2-negative, ESR1-mutated metastatic breast cancer.

"We enter the second half of 2026 with a clear focus on executing our Phase 3 ELAINE-3 trial and advancing lasofoxifene toward what we believe could be a transformative treatment option for patients with ESR1-mutated metastatic breast cancer," said Mark Litton, Ph.D., President and Chief Executive Officer of LeonaBio.

Clinical trial spending drives R&D expenses higher

Investment in ELAINE-3 contributed to a sharp increase in LeonaBio's research and development expenditure during the quarter.

R&D expenses climbed to $12.9 million from $3.7 million in the second quarter of 2025, with the increase primarily reflecting spending associated with the Phase 3 trial.

General and administrative expenses also increased, reaching $6.6 million compared with $3.6 million a year earlier. The company attributed the rise to higher personnel costs and professional service fees.

The heavier investment in clinical development and administration contributed to the year-on-year widening of LeonaBio's net loss.

Cash position declines as development spending accelerates

LeonaBio ended June with $51.1 million in cash, cash equivalents and investments, down from $88.3 million at the end of 2025.

Net cash used in operations reached $37.9 million during the quarter, compared with $21.7 million in the second quarter of last year.

With ELAINE-3 progressing towards completion of enrolment, investors are likely to focus on the company's remaining cash resources alongside execution of the trial. The next major clinical milestones include completing patient recruitment in the fourth quarter and reaching the anticipated topline data readout in the second half of 2027.

LeonaBio stock price