Every 8-K that LeonaBio, Inc. (LONA) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow LONA and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full LONA filings page.
LeonaBio, Inc. (LONA) reported enrollment of the 500th subject in its ongoing Phase 3 ELAINE-3 clinical trial of lasofoxifene in combination with abemaciclib for ER-positive, HER2-negative, ESR1-mutated metastatic breast cancer after progression on aromatase inhibitors and CDK4/6 inhibitors.
LeonaBio previously issued 23,031,494 Series A Common Warrants in a December 2025 private placement, each with an exercise price of $6.35 per share, generally payable in cash unless a resale registration statement is unavailable, in which case they may be exercised on a cashless net basis. The warrants become exercisable at each holder’s option after the earlier of (1) the latest of June 30, 2026, the publicly announced ELAINE-3 Enrollment Date, and specified FDA action on Eli Lilly’s imlunestrant plus abemaciclib application, and (2) October 31, 2026, and remain exercisable for 30 days, no later than November 30, 2026. If exercised in full for cash, they would provide approximately $146.2 million of additional capital.
LeonaBio reported results for the quarter ended June 30, 2026 and highlighted progress across its oncology and neurodegeneration pipeline. The company’s lead program, lasofoxifene, is being evaluated in the Phase 3 ELAINE-3 trial in ER-positive, HER2-negative, ESR1‑mutated metastatic breast cancer in combination with abemaciclib. Enrollment has reached 495 patients, and LeonaBio expects to complete enrollment of approximately 600 participants in 4Q 2026, with topline data expected in the second half of 2027.
Lasofoxifene previously showed encouraging activity in the Phase 2 ELAINE‑1 and ELAINE‑2 studies, and LeonaBio is investing in CMC, regulatory and commercial readiness ahead of potential approval. The company also advanced brelgometon (ATH‑1105), which completed a first‑in‑human Phase 1 trial in 80 healthy volunteers, demonstrating favorable safety, tolerability and CNS penetration, supporting a planned Phase 2 proof‑of‑concept trial in ALS.
Cash, cash equivalents and investments were $51.1 million as of June 30, 2026. Net cash used in operations was $37.9 million for the quarter. Research and development expenses rose to $12.9 million, general and administrative expenses to $6.6 million, and net loss to $19.0 million, or $0.80 per share. The company points to up to an additional $146 million in potential proceeds from cash‑exercisable warrants issued in its December 2025 financing as a key funding source for upcoming milestones.
LeonaBio, Inc. reported the results of its 2026 Annual Meeting of Stockholders. Of 9,393,514 common shares outstanding as of May 1, 2026, 7,908,604 shares were present or represented by proxy, representing approximately 84.19% of shares entitled to vote, which was enough to conduct business.
Stockholders elected three Class III directors—Kelly A. Romano, James A. Johnson and Natalie Holles—to terms running until the 2029 annual meeting, with strong majorities of votes cast in favor. They also ratified the appointment of Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026.
In advisory votes, stockholders approved the compensation of LeonaBio’s named executive officers and indicated a preference to hold future advisory votes on executive pay every three years. The company and its board plan to follow a three-year frequency until the next required vote on this question.
LeonaBio, Inc. reported first quarter 2026 results and highlighted progress in its oncology and neurodegeneration pipeline. The company is running the Phase 3 ELAINE‑3 trial of lasofoxifene in ER‑positive, HER2‑negative, ESR1‑mutated metastatic breast cancer, plans to increase enrollment to up to 600 patients, expects to complete enrollment in 4Q 2026 and to report topline data in the second half of 2027.
ATH‑1105, an oral, brain‑penetrant candidate for ALS, showed favorable safety, pharmacokinetics and CNS penetration in a Phase 1 trial, and LeonaBio aims to start a Phase 2 proof‑of‑concept study in ALS patients in the second half of 2026. Cash, cash equivalents and investments were $67.7 million as of March 31, 2026, compared with $88.3 million as of December 31, 2025, reflecting higher operating spend.
Research and development expenses rose to $11.3 million for the quarter from $4.3 million a year earlier, mainly from the ELAINE‑3 trial, while general and administrative expenses increased to $6.9 million from $5.2 million. Net loss widened to $32.9 million, or $1.73 per share, from $9.1 million, or $2.34 per share, driven in part by a non‑cash $16.3 million change in fair value of a Sermonix pre‑funded warrant.
LeonaBio, Inc. filed a second amendment to an earlier report to align with SEC guidance treating its Sermonix transaction as an acquisition of a business. The company obtained a waiver from certain financial statement requirements in exchange for providing expanded qualitative and cash expenditure disclosures.
The amendment details historical unaudited cash spending on the ELAINE-3 Study, including about $14 million, $12 million and $5 million by Sermonix in 2023, 2024 and part of 2025, and approximately $11 million by LeonaBio from December 18 through December 31, 2025. LeonaBio now expects to spend about $45 million in 2026 and $30 million in 2027 as it broadens the study scope.
The company has increased the ELAINE-3 Study intensity, expanded the contract research organization’s responsibilities, and plans to raise the sample size from 500 to up to 600 participants. It currently expects to complete enrollment in the fourth quarter of 2026 and release topline data in the second half of 2027.
LeonaBio, Inc. reported full-year 2025 results and highlighted a major strategic shift toward oncology and neurodegeneration. For the year ended December 31, 2025, cash, cash equivalents and investments rose to $88.3 million from $51.3 million, helped by a $90 million private placement of common stock and warrants that could bring in up to an additional $146 million if fully exercised.
Research and development expenses increased to $85.6 million, mainly from $68.1 million of acquired in‑process R&D tied to the lasofoxifene license, while general and administrative expenses fell to $16.7 million. Net loss widened modestly to $105.6 million, or $24.70 per share, compared with $96.9 million, or $25.19 per share, in 2024.
The company acquired an exclusive global license (excluding Asia and certain Middle East countries) to late‑stage breast cancer drug candidate lasofoxifene and is running the Phase 3 ELAINE‑3 trial, expecting enrollment completion in 4Q 2026 and topline data in 2H 2027. Its ALS candidate ATH‑1105 showed favorable Phase 1 safety and CNS penetration, with a Phase 2 proof‑of‑concept study in ALS planned to start in the second half of 2026.
LeonaBio, Inc. reported results of a special stockholder meeting where several major equity actions were approved. Stockholders adopted a new 2026 Equity Incentive Plan allowing issuance of up to 5,700,000 shares, plus up to 1,300,000 additional shares recycled from certain expired or forfeited awards under the prior 2020 plan, and an annual increase tied to up to 5% of outstanding common stock and pre-funded warrants.
Stockholders also approved potential issuances of common stock upon exercise of a Sermonix pre-funded warrant for 5,502,402 shares and additional warrant exercises by Perceptive Advisors that could raise their beneficial ownership above 19.99%, consistent with Nasdaq Rules 5635(a)(2) and 5635(b). In a major capital structure change, authorized common stock increased from 90,000,000 to 400,000,000 shares and total authorized capital stock from 190,000,000 to 500,000,000 shares via a certificate of amendment filed on March 18, 2026.