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Athira Pharma Status Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Status Update summary18 Dec, 2025
Strategic transformation, licensing, and pipeline expansion
Secured exclusive global license (excluding Asia and select Middle East countries) for lasofoxifene, a selective estrogen receptor modulator, targeting metastatic breast cancer with ESR1 mutations, diversifying the pipeline with a late-stage oncology program.
Continued advancement of ATH-1105 for ALS, a CNS-penetrant HGF modulator, with Phase 2 proof-of-concept study planned for early 2026 and topline results expected in 2027.
Plans to rebrand to reflect a broader mission focused on leadership, resilience, and innovation in transformative therapies.
Leadership team brings deep expertise in drug development, regulatory strategy, and commercialization, supported by blue-chip investors.
Strategy aims to deliver life-changing therapies and generate enduring shareholder value.
Lasofoxifene clinical and commercial opportunity
Lasofoxifene targets ER-positive, HER2-negative metastatic breast cancer with ESR1 mutations, addressing a growing market projected to reach $41.7 billion by 2030.
Demonstrated 13 months median progression-free survival in Phase 2 combination trial (ELAINE-2) and superior tolerability profile.
ELAINE-3 Phase 3 trial is over 50% enrolled, comparing lasofoxifene + abemaciclib to fulvestrant + abemaciclib, with topline data expected mid-2027.
Unique tissue-selective pharmacology offers quality-of-life benefits, including improvements in urogenital symptoms and bone health.
Commercial potential validated by comparable drugs, with peak annual U.S. sales for lasofoxifene estimated near $1 billion if approved.
ATH-1105 ALS program update
ATH-1105 is an orally available, CNS-penetrant small molecule modulating the HGF/Met pathway, showing robust neuroprotection in preclinical ALS models.
Demonstrated preservation of motor function, reduced neurodegeneration, and significant reduction in plasma NfL biomarker in animal studies.
Phase 1 study in healthy volunteers showed favorable safety, PK, CNS penetration, and target engagement consistent with preclinical efficacy.
Phase 2 proof-of-concept trial in ALS patients is being planned to assess safety, efficacy, and biomarker validation, with topline results expected in 2027.
Potential for broader application in other neurodegenerative diseases based on HGF modulation biology.
Lasofoxifene differentiation in MBC market
Quantify potential dilution from financing warrants
Impact on ATH-1105 development timeline
Lasofoxifene's QoL benefits vs. competitors?
ATH-1105 Phase II de-risking strategy?
Lasofoxifene's post-ELAINE-3 expansion?
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Next Athira Pharma earnings date
Q4 202520 Feb, 2026
Next Athira Pharma earnings date
Q4 202520 Feb, 2026
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Frequently asked questions
Athira Pharma Inc., also known as Athira Pharma, is a late clinical-stage biopharmaceutical company focused on developing small molecules aimed at restoring neuronal health and slowing neurodegeneration. The company's leading product candidate, ATH-1017 (Fosgonimeton), is designed to enhance the activity of the hepatocyte growth factor (HGF) and its receptor, MET. The company is headquartered in Bothell, Washington, and its shares are listed on the NASDAQ.
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