Business Context and Reporting Period
Company: LeonaBio, Inc. (formerly Athira Pharma, Inc.)
Filing Type: Form 10-K (Annual Report)
Period Ended: December 31, 2025
Business Overview: LeonaBio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for treatment-resistant metastatic breast cancer and amyotrophic lateral sclerosis (ALS). In December 2025, the company rebranded and acquired exclusive global rights (excluding Asia and certain Middle Eastern countries) to lasofoxifene, a late-stage asset for breast cancer, from Sermonix Pharmaceuticals. The company also continues development of its internal asset, ATH-1105, for ALS.
Key Financial Metrics
| Metric | 2025 (in millions) | 2024 (in millions) |
|---|---|---|
| Revenue | $0.0 | $0.0 |
| Net Loss | $(105.6) | $(96.9) |
| Operating Expenses | $102.3 | $100.9 |
| Cash, Cash Equivalents & Investments | $88.3 | $51.3 |
| Accumulated Deficit | $(511.8) | $(406.1) |
| Net Cash Used in Operating Activities | $(45.7) | $(97.2) |
| Net Cash Provided by Financing Activities | $82.5 | $0.2 |
Note: The company has no revenue and operates at a loss. The 2025 net loss includes a significant non-cash charge of $68.1 million for acquired in-process research and development (IPR&D) related to the lasofoxifene license.
Material Changes vs. Prior Period
- Strategic Acquisition: In December 2025, LeonaBio in-licensed lasofoxifene for the treatment of ESR1-mutated metastatic breast cancer. This resulted in a one-time $68.1 million IPR&D expense and the assumption of approximately $16.8 million in third-party liabilities.
- Capital Raise: The company completed a private placement (PIPE) in December 2025, raising approximately $90 million in gross proceeds. This significantly improved liquidity compared to the prior year.
- Workforce Reduction: Following a 70% workforce reduction in late 2024, General and Administrative (G&A) expenses decreased by 36% in 2025 to $16.7 million.
- Legal Expenses: Legal expenses dropped to zero in 2025 from $4.1 million in 2024, as the DOJ investigation and related litigation were resolved in the prior year.
- Stock Split: A 1-for-10 reverse stock split was effected in September 2025 to regain compliance with Nasdaq listing standards.
Guidance, Outlook, and Risks
Outlook and Guidance:
- Liquidity: Management estimates that existing cash, cash equivalents, and investments ($88.3 million) are sufficient to fund operations for at least the next 12 months following the report date.
- Clinical Milestones:
- Lasofoxifene: The pivotal Phase 3 ELAINE-3 trial is underway with over 50% recruitment completed as of December 2025. Topline data is expected in the second half of 2027.
- ATH-1105: Planning for a Phase 2 proof-of-concept trial for ALS is underway, with an anticipated start in 2026.
Key Risks and Contingencies:
- Form S-3 Ineligibility: Due to a failure to timely file a Form 8-K, the company is ineligible to use Form S-3 for capital raises until December 2026, potentially impairing its ability to raise capital expeditiously.
- Development Risk: As a clinical-stage company with no marketed products, success depends entirely on the successful completion of clinical trials and regulatory approval, which is uncertain.
- Financial Obligations: The company has contingent milestone payment obligations to Sermonix (up to $100 million) and Ligand (up to $14.75 million) upon commercialization, as well as ongoing royalty obligations.
- Stockholder Approval: Stockholder approval for the Sermonix pre-funded warrant exercise was obtained in March 2026, terminating the redemption right associated with the warrant.
Investor Verification Checklist
- Cash Runway: Verify the sufficiency of the $88.3 million cash balance against the projected burn rate for the ELAINE-3 trial and ATH-1105 Phase 2 development.
- Form S-3 Status: Confirm the timeline for regaining Form S-3 eligibility and the impact on future fundraising flexibility.
- ELAINE-3 Trial Progress: Monitor recruitment rates and any protocol amendments for the lasofoxifene Phase 3 trial, as this is the primary value driver.
- Related Party Transactions: Review the terms of the Sermonix license and the PIPE financing, noting that Perceptive Advisors (affiliated with a board member) participated in the PIPE and holds a significant stake in Sermonix.
- Warrant Liabilities: Track the fair value changes of the Sermonix pre-funded warrant and milestone liabilities, which are recorded as liabilities and remeasured quarterly, impacting net income.