**LeonaBio, Inc. Announces Year-End Financial Results and Provides Business Update**
LeonaBio, Inc., a clinical-stage biopharmaceutical company, reported its financial results for the year ended December 31, 2025, showcasing a net loss of $105.6 million, compared to a net loss of $96.9 million in 2024. The increased loss was primarily attributed to a $68.1 million expense related to acquired in-process research and development (IPR&D) following the in-licensing of lasofoxifene, a selective estrogen receptor modulator (SERM) being evaluated in a Phase 3 trial for metastatic breast cancer with ESR1 mutations. This was partially offset by decreased spending on other research and development programs, most notably a $39.2 million reduction in expenses related to fosgonimeton (ATH-1017) after the Phase 2/3 LIFT-AD clinical trial did not meet its primary or key secondary endpoints.
The company's research and development expenses totaled $85.6 million for 2025, up from $70.7 million in the prior year. This increase reflects the strategic shift towards oncology with the lasofoxifene program, as well as continued investment in ATH-1105, a small-molecule positive modulator of the neurotrophic HGF system in Phase 2 development for ALS. General and administrative expenses decreased to $16.7 million in 2025 from $26.1 million in 2024, primarily due to a reduction in professional services and personnel-related expenses following a workforce reduction. Other income, net, decreased by $2.7 million, from $4.0 million for the year ended December 31, 2024 to $1.2 million for the year ended December 31, 2025 due to lower income from accretion of discounts on debt securities purchased below par value and lower interest income earned on available-for-sale securities.
Key operational developments included the December 2025 in-licensing of lasofoxifene, a late-stage asset for ESR1-mutated metastatic breast cancer, and the ongoing registrational Phase 3 ELAINE-3 trial. LeonaBio is amending the ELAINE-3 trial protocol to increase the sample size from 500 to up to 600 participants to ensure an appropriate number of disease progression events. The company also completed a Phase 1 trial for ATH-1105 in healthy volunteers, with planning underway for a Phase 2 clinical trial in ALS patients anticipated to start in 2026. As of December 31, 2025, LeonaBio had 19 full-time employees, with 10 dedicated to research and development activities.
Looking ahead, LeonaBio anticipates that its existing cash, cash equivalents, and investments of $88.3 million as of December 31, 2025, will be sufficient to fund operating expenses and capital expenditure requirements for at least the next 12 months. The company expects to continue to incur significant operating losses and will require substantial additional funding to advance its clinical programs and commercialization efforts. LeonaBio may seek additional capital through equity offerings, debt financings, collaborations, or other strategic arrangements. The company is currently ineligible to file registration statements on Form S-3, which may impair its ability to raise capital on favorable terms.
About Athira Pharma, Inc.
Athira Pharma, Inc. is a clinical-stage biopharmaceutical company developing orally available small molecule therapeutics that modulate the neurotrophic hepatocyte growth factor (HGF) system to restore neuronal health and slow neurodegeneration. Its lead candidate, ATH-1105, targets neurodegenerative diseases like ALS by promoting neuroprotection, reducing inflammation, and enhancing nerve function. Athira leverages proprietary drug discovery, third-party manufacturing, and aims to address unmet needs in central and peripheral nervous system disorders.
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