LeonaBio reports second quarter 2026 results and ELAINE-3 update

LeonaBio, Inc. (NASDAQ: LONA) reported financial results for the quarter ended June 30, 2026 in a release dated August 14, 2026, and provided a business update. Chief Executive Officer Mark Litton, Ph.D., said the company has enrolled 495 patients in its Phase 3 ELAINE-3 trial and expects to complete enrollment in the fourth quarter of 2026, with topline data expected in the second half of 2027.

Lasofoxifene and ELAINE-3

The release describes lasofoxifene as a third generation, nonsteroidal selective estrogen receptor modulator with a binding profile designed to act against both wild-type and mutant estrogen receptors. In December 2025, LeonaBio acquired an exclusive global license to develop and commercialize the drug from Sermonix Pharmaceuticals, Inc., excluding Asia and certain countries in the Middle East.

ELAINE-3 is a Phase 3 trial in combination with abemaciclib, a CDK4/6 inhibitor. The primary endpoint is a statistically significant improvement in progression-free survival as determined by blinded, independent central review. The company expects to complete enrollment of about 600 participants in the fourth quarter of 2026.

The company recalled two earlier Phase 2 studies. In ELAINE-1, an open-label randomized trial comparing lasofoxifene with fulvestrant, median progression-free survival was 5.6 months against 3.7 months, and the objective response rate was 13.3% against 2.9%. The trial was not powered, but one complete response has lasted more than 2.5 years. In ELAINE-2, an open-label study of lasofoxifene with abemaciclib in heavily pretreated patients, median progression-free survival was approximately 13 months, the objective response rate was 56%, and the clinical benefit rate was 65.5%.

Brelgometon and the board

The company's other clinical program is brelgometon, also known as ATH-1105. The release describes it as an orally available, brain-penetrant small molecule designed to positively modulate the neurotrophic HGF system, for potential treatment of ALS, Alzheimer's disease and Parkinson's disease. Its first-in-human Phase 1 trial enrolled 80 healthy volunteers and showed a favorable safety and tolerability profile, dose-proportional pharmacokinetics and CNS penetration. The company will update the timing of a proposed Phase 2 proof-of-concept trial after enrollment in ELAINE-3 is complete.

LeonaBio also appointed Fred Callori, J.D., Natalie Holles and Peter B. Silverman, J.D. to its board of directors, effective May 5, 2026. John Fluke, Jr., who had served on the board since 2014, retired effective May 4, 2026.

Financial position

Cash, cash equivalents and investments were $51.1 million at June 30, 2026, compared with $88.3 million at December 31, 2025. Net cash used in operations was $37.9 million for the quarter, compared with $21.7 million for the second quarter of 2025. Research and development expenses were $12.9 million for the quarter, compared with $3.7 million a year earlier, driven primarily by clinical trial spending on ELAINE-3. General and administrative expenses were $6.6 million, compared with $3.6 million, driven primarily by personnel-related expenses, including stock-based compensation.

The release recalls a $90 million private placement of common stock and warrants completed in December 2025, and says the Series A warrants could provide up to an additional $146 million if exercised in full. The annual report figures in SEC XBRL data show research and development expense of $17.5 million for 2025 and a net loss of $105.6 million for the same year.

What the data do not show

The efficacy figures are from earlier studies, not from ELAINE-3. ELAINE-1 was open-label and, as the release itself says, not powered, and the release gives no p-values for the comparison with fulvestrant. ELAINE-2 was an open-label study of heavily pretreated patients with no comparison arm in the release, so its 13-month median progression-free survival says little about benefit over standard care. Topline data from ELAINE-3 are not expected until the second half of 2027.

Brelgometon has only Phase 1 data from healthy volunteers, with no efficacy reported, and no Phase 2 start date is given because timing will be updated only after ELAINE-3 enrollment is complete. On money, cash, cash equivalents and investments fell to $51.1 million at June 30, 2026 from $88.3 million at December 31, 2025, and operations used $37.9 million in the quarter alone. The warrant proceeds of up to $146 million depend on holders exercising, and exercise would add shares.

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