LeonaBio
LeonaBio is a clinical-stage biopharmaceutical company developing novel small-molecule therapeutics, with lead Phase 3 program lasofoxifene for ESR1-mutant metastatic breast cancer and Phase 2-ready ATH-1105 for ALS, targeting oncology and neurodegenerative indications with high unmet need.
- Company typePublic
- Founded2019
- HeadquartersBothell, United States
- Headcount51–100
- GTM typeB2B
- OfferingHardware or Manufacturing
What LeonaBio does
LeonaBio is a clinical-stage biopharmaceutical company headquartered in Bothell, Washington, developing novel small-molecule therapeutics for diseases with high unmet medical need. Its pipeline is anchored by two differentiated mechanisms: lasofoxifene, a selective estrogen receptor modulator (SERM) with a unique binding profile active against both wild-type and clinically significant ESR1-mutant estrogen receptors, currently in the registrational ELAINE-3 Phase 3 trial for ER+/HER2- metastatic breast cancer in combination with abemaciclib; and ATH-1105, an orally available, brain-penetrant positive modulator of the neurotrophic hepatocyte growth factor (HGF) system, with Phase 1 data demonstrating favorable safety, dose-proportional pharmacokinetics, and CNS penetration, and a Phase 2 proof-of-concept trial in ALS planned for the second half of 2026. Earlier-stage pipeline includes ATH-1020 (preclinical/Phase 1 complete in diabetic neuropathy) and fosgonimeton (previously evaluated in Alzheimer's/Parkinson's trials).
The company was originally founded as M3 Biotechnology, rebranded to Athira Pharma in 2019, and renamed LeonaBio, Inc. in January 2026 following the December 2025 acquisition of exclusive global development and commercialization rights to lasofoxifene from Sermonix Pharmaceuticals (excluding Asia and certain Middle Eastern countries). The transaction marked a deliberate strategic pivot from a pure neurodegeneration focus toward an oncology-led pipeline, supported by a $90 million private placement co-led by Commodore Capital, Perceptive Advisors, and TCGX that provides cash runway into 2028.
As a clinical-stage biotech, LeonaBio currently has no product revenue and no commercial pricing in place; future economics would come from FDA-approved drug commercialization through standard pharmaceutical and specialty-pharmacy channels, supplemented by potential licensing or partnership income for geographies excluded from the Sermonix agreement. The company engages its eventual physician audience (oncologists and neurologists) through medical-affairs channels, scientific publications in journals such as Annals of Oncology and Frontiers in Neurology, and participation in major medical meetings (AACR, BIO International Convention, ALS Drug Development Summit). Its institutional investor base is concentrated in life-sciences-specialist funds, with Perceptive Advisors also represented on the board following a May 2026 governance refresh.
LeonaBio firmographics
Firmographics- Name
- LeonaBio
- Legal name
- LeonaBio, Inc.
- Website
- https://leonabio.com
- Company type
- Public
- Founded year
- 2019
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- LeonaBio is a clinical-stage biopharmaceutical company developing novel small-molecule therapeutics, with lead Phase 3 program lasofoxifene for ESR1-mutant metastatic breast cancer and Phase 2-ready ATH-1105 for ALS, targeting oncology and neurodegenerative indications with high unmet need.
- Ownership category
- akta.pro rank
LeonaBio industry classification
Industry- Product category
- Clinical-stage Biopharmaceuticals / Oncology and Neurology Therapeutics
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)
- SIC
- Services-Commercial Physical & Biological Research (8731), Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Target Identification & Validation Platforms (omics-driven, chemoproteomics, genetic validation) (HLAAAIAI)
- akta.pro secondary industry
- Lead Optimization & Preclinical Candidate Selection (HLAIALAB)
Keywords
Where LeonaBio is headquartered
LocationHeadquarters
- HQ city
- Bothell
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
LeonaBio business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales
Revenue model
- Pharmaceutical Drug Sales: As a clinical-stage biopharmaceutical company, LeonaBio currently has no product revenue. The company is developing lasofoxifene (Phase 3) for ER+/HER2-/ESR1-mutant metastatic breast cancer and ATH-1105 (Phase 2 planned) for ALS. Future revenue would come from commercializing FDA-approved drugs through standard pharmaceutical distribution channels.
Go-to-market motion2 records
Distribution channels1 record
Marketing channels4 records
LeonaBio product offering
Product offeringCore offering
LeonaBio is a late-clinical-stage biopharmaceutical company developing novel small molecule therapeutics for diseases with high unmet medical needs. Its lead asset, lasofoxifene, is a selective estrogen receptor modulator (SERM) in Phase 3 development for ER+/HER2-/ESR1-mutated metastatic breast cancer. Its second lead program, ATH-1105, is an orally available, brain-penetrant small molecule targeting the neurotrophic HGF system for ALS, with a Phase 2 proof-of-concept trial planned for H2 2026.
Product overview
LeonaBio is a late-clinical stage biopharmaceutical company developing novel small molecule therapeutics for diseases with high unmet medical needs. The company's lead drug candidates include lasofoxifene (a SERM in Phase 3 for ER+/HER2-/ESR1-mutated metastatic breast cancer) and ATH-1105 (a HGF positive modulator in Phase 2 planning for ALS). Additional pipeline candidates include ATH-1020 (diabetic neuropathy) and fosgonimeton (Alzheimer's/Parkinson's). The company also maintains early-stage compounds in preclinical discovery for neurodegenerative diseases.
Differentiator
Problem solved
Functional benefit
Products and services
- Lasofoxifene A novel, nonsteroidal selective estrogen receptor modulator (SERM) with a unique binding profile designed to confer potent activity against both wild-type and mutant estrogen receptors, including clinically significant ESR1 mutations commonly associated with resistance to endocrine therapy in metastatic breast cancer. Currently in Phase 3 (ELAINE-3 trial) for ER+/HER2-/ESR1-mutated metastatic breast cancer in combination with abemaciclib after CDK4/6 inhibitor progression.
- ATH-1105 A novel, orally available, brain-penetrant, next-generation small molecule drug candidate designed to positively modulate the neurotrophic HGF system for potential treatment of neurodegenerative diseases, including ALS. Phase 2 proof-of-concept trial in ALS patients planned for H2 2026.
- ATH-1020 A novel, orally available, next-generation small molecule drug candidate designed to positively modulate the neurotrophic HGF system. In preclinical models, ATH-1020 reduced measures of pain in models of diabetic neuropathy. Phase 1 completed; company to evaluate options for advancement.
- Fosgonimeton (ATH-1017)
Quantifiable outcome
- Phase 3 data for lasofoxifene expected mid-2027
- +4 more outcomes
Companies that use LeonaBio
Customer profileNamed customers1 record
Segments3 records
Ideal customer profiles3 records
LeonaBio technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
LeonaBio partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered supporting and core.
- Virginia Commonwealth University Massey Comprehensive Cancer CentersupportingIndependent researchers at VCU's Massey Comprehensive Cancer Center presented nonclinical data on lasofoxifene at AACR26 annual meeting, showing the drug protected against hormone withdrawal-induced bone loss while maintaining anti-tumor response in ER+ breast cancer models.
- Sermonix PharmaceuticalscoreLeonaBio entered into an exclusive global license agreement (excluding Asia and certain Middle Eastern countries) with Sermonix Pharmaceuticals to develop and commercialize lasofoxifene, a Phase 3 SERM asset for metastatic breast cancer. LeonaBio paid approximately $34.9 million in equity plus monthly payments and up to $100 million in potential milestones.
Scale indicators10 records
Recent moves7 records
Expansion highlights6 records
LeonaBio competitors and assessment
Company assessmentDirect peers
- Arvinas: Clinical-stage biotech developing targeted protein degraders (PROTAC) including vepdegestrant in partnership with Pfizer for ER+/HER2- metastatic breast cancer, including ESR1-mutant populations. Overlapping breast cancer franchise targeting resistance mechanisms after endocrine therapy.
- Sermonix Pharmaceuticals: Originating developer of lasofoxifene and direct licensor to LeonaBio (December 2025 exclusive global license excluding Asia/ME). Sermonix retains rights in excluded territories and continues SERD/SERM development in metastatic breast cancer, making it the most directly comparable peer.
- Helixmith: Clinical-stage biotech developing neurotrophic factor-based therapies for peripheral neuropathy and ALS, with direct overlap to LeonaBio's HGF-MET approach. Comparable mechanism class targeting neuronal regeneration in neurodegenerative disease.
- Ionis Pharmaceuticals: Clinical-stage RNA-targeted biotech developing tofersen (Qalsody) for SOD1-mutant ALS, a leading approved ALS therapy. Comparable specialty biotech with CNS-penetrant mechanism for neurodegenerative disease, sharing patient enrollment challenges in ALS trials.
- Cytokinetics: Late-clinical stage biotech developing tirasemtiv and reldesemtiv for ALS, with deep experience in ALS drug development. Directly comparable neuro-targeting biotech with similar clinical-stage risk profile and pipeline focus on motor neuron diseases.
- Anavex Life Sciences: Clinical-stage biotech developing ANAVEX 2-73 (blarcamesine) for Alzheimer's, Rett syndrome and other neurodegenerative diseases including ALS. Similar small molecule CNS-penetrant approach to treating neuro indications with high unmet need.
- Olema Oncology: Clinical-stage oncology company developing targeted endocrine therapies for ER+/HER2- metastatic breast cancer, including ESR1-targeted candidates. Direct competitor to LeonaBio in the same patient population with a similar strategic focus on post-CDK4/6 resistance.
Broad incumbents
- Genentech (Roche): Major oncology incumbent developing giredestrant (oral SERD) for ER+/HER2- metastatic breast cancer including ESR1-mutant populations. Broad pharma with deep breast cancer franchise that competes directly with LeonaBio's target population and pricing environment.
- Eli Lilly: Largest oncology incumbent in ER+/HER2- breast cancer via Verzenio (abemaciclib) — the very CDK4/6 inhibitor LeonaBio's ELAINE-3 combines lasofoxifene with. Broad incumbent with overlap in metastatic breast cancer but operates across many therapeutic areas.
- Biogen: Large biopharmaceutical company with established ALS franchise (Spinraza, Qalsody) and broad neurodegenerative pipeline. Broader incumbent operating across multiple therapeutic areas, but its ALS neurology focus makes it a relevant competitive reference for ATH-1105's market entry.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks5 records
Key highlights7 records
Customer concentration
LeonaBio social profiles
Digital presenceLeonaBio financial estimates
Financial estimateRevenue estimate
Valuation estimate
LeonaBio leadership team
Management profileNumber of profiles
Profiles1 record
LeonaBio funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
LeonaBio M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about LeonaBio
What does LeonaBio do?
LeonaBio is a late-clinical-stage biopharmaceutical company developing novel small molecule therapeutics for diseases with high unmet medical needs. Its lead asset, lasofoxifene, is a selective estrogen receptor modulator (SERM) in Phase 3 development for ER+/HER2-/ESR1-mutated metastatic breast cancer. Its second lead program, ATH-1105, is an orally available, brain-penetrant small molecule targeting the neurotrophic HGF system for ALS, with a Phase 2 proof-of-concept trial planned for H2 2026.
Is LeonaBio a public or private company?
LeonaBio is a public company. It is classified as public and is currently operating.
When was LeonaBio founded?
LeonaBio was founded in 2019. It employs 51 to 100 people.
Where is LeonaBio based?
LeonaBio is headquartered in Bothell, United States, in the North America region.
How does LeonaBio make money?
One revenue line is on record: pharmaceutical Drug Sales.
Who are LeonaBio's main competitors?
Direct peers on record are Arvinas, Sermonix Pharmaceuticals, Helixmith, Ionis Pharmaceuticals, Cytokinetics, Anavex Life Sciences and Olema Oncology. Broad incumbents are Genentech (Roche), Eli Lilly and Biogen.
Does LeonaBio have an API?
No public API is recorded for LeonaBio.
What industry is LeonaBio in?
LeonaBio's product category is Clinical-stage Biopharmaceuticals / Oncology and Neurology Therapeutics. Its primary akta.pro industry code is HLAAAIAI, Target Identification & Validation Platforms (omics-driven, chemoproteomics, genetic validation), with a secondary code of HLAIALAB, Lead Optimization & Preclinical Candidate Selection. Its NAICS code is 541714 and its SIC code is 8731.