Atossa Therapeutics
- Company typePublic
- Founded2009
- HeadquartersSeattle, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
Atossa Therapeutics firmographics
Firmographics- Name
- Atossa Therapeutics
- Legal name
- Atossa Therapeutics, Inc.
- Website
- https://atossatherapeutics.com
- Company type
- Public
- Founded year
- 2009
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Ownership category
- akta.pro rank
Atossa Therapeutics industry classification
Industry- Product category
- Oncology Pharmaceuticals
- NAICS
- Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Oncology & Hematology Pharmaceuticals (HLAIAAAC)
- akta.pro secondary industry
- Oncology Specialty Pharmaceuticals (HLAIACAA)
Keywords
Where Atossa Therapeutics is headquartered
LocationHeadquarters
- HQ city
- Seattle
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Atossa Therapeutics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Others
Revenue model
- No Commercial Revenue: Atossa Therapeutics is a clinical-stage biopharmaceutical company with no current commercial products or sustainable revenue. The company is focused entirely on R&D investment to advance (Z)-endoxifen through clinical development toward regulatory approval. No revenue is generated from product sales.
- Potential Future Product Revenue: Upon regulatory approval, the company plans to commercialize (Z)-endoxifen for breast cancer and rare disease indications. Analysts project potential positive profits of $48M in 2028 if clinical development succeeds.
- Priority Review Voucher (PRV): FDA Rare Pediatric Disease designation for (Z)-endoxifen in DMD and McCune-Albright Syndrome qualifies the company for a Priority Review Voucher upon approval, which can be sold for approximately $100-205 million based on recent market transactions.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | — | No commercial products available for pricing |
Go-to-market motion2 records
Distribution channels1 record
Marketing channels5 records
Atossa Therapeutics product offering
Product offeringCore offering
Atossa Therapeutics is a clinical-stage biopharmaceutical company developing (Z)-endoxifen, a proprietary oral selective estrogen receptor modulator and degrader (SERM/SERD) formulated in an enteric capsule. The drug is being advanced through multiple Phase 2 clinical trials for breast cancer (metastatic, neoadjuvant, ductal carcinoma in situ, and breast density reduction) and rare diseases (Duchenne Muscular Dystrophy, McCune-Albright Syndrome, and potentially glioblastoma). All candidates are investigational, with no approved products or commercial revenue.
Product overview
Atossa Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines in oncology with a current focus on breast cancer. The company's primary product candidate is (Z)-endoxifen, a potent selective estrogen receptor modulator (SERM) that is nearly 100 times more potent than other SERMs. (Z)-endoxifen is being advanced across multiple clinical development programs including the EVANGELINE Phase 2 trial for neoadjuvant treatment of ER+/HER2- breast cancer, the KARISMA-Endoxifen trial for mammographic breast density reduction, the I-SPY 2 trial for neoadjuvant therapy, and the RECAST DCIS study for ductal carcinoma in situ. The company is also pursuing development for rare diseases including Duchenne Muscular Dystrophy and McCune-Albright Syndrome, having received FDA Orphan Drug Designation and Rare Pediatric Disease designation for these indications.
Differentiator
Problem solved
Functional benefit
Products and services
- (Z)-endoxifen (Z)-endoxifen is Atossa's proprietary oral selective estrogen receptor modulator (SERM) and degrader (SERD), developed to be approximately 100 times more potent than other SERMs with a potentially improved tolerability profile. It is formulated in an enteric capsule that bypasses stomach acidity, requires no liver metabolism for activation, and targets Protein Kinase C beta 1 (PKCβ1) in addition to estrogen receptor inhibition. The candidate is being advanced through multiple Phase 2 trials in breast cancer and rare diseases.
Quantifiable outcome
- 92% reduction in Ki-67 after 24 weeks with 40mg (Z)-endoxifen in EVANGELINE Phase 2 study
- +7 more outcomes
Companies that use Atossa Therapeutics
Customer profileNamed customers1 record
Segments4 records
Ideal customer profiles2 records
Atossa Therapeutics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability2 records
Feature5 records
Atossa Therapeutics partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered core.
- PSI (Contract Research Organization)corePSI serves as the contract research organization (CRO) for Atossa's pivotal dose-ranging study for metastatic breast cancer. PSI supports clinical trial execution, site management, and data collection for the Phase 2/3 development of (Z)-endoxifen in this indication.
- Insilico MedicinecoreJoint study published in Nature Scientific Reports using AI-driven analysis to identify (Z)-endoxifen as a potential treatment for glioblastoma multiforme (GBM). Insilico Medicine applied its AI platform to screen cancer indications and validate endoxifen's efficacy against GBM cells in vitro and in vivo.
- Quantum Leap Healthcare CollaborativecoreOngoing collaboration on multiple clinical trials: (Z)-endoxifen is being evaluated in the I-SPY 2 Endocrine Optimization Pilot Protocol (EOP), including a new study arm evaluating (Z)-endoxifen in combination with abemaciclib (VERZENIO). Also collaborating on the RECAST DCIS platform study for ductal carcinoma in situ.
- Weill Cornell MedicinecoreResearch agreement to study the potential of inducing estrogen receptor (ER) expression in triple-negative breast cancer (TNBC). The goal is to determine if treating TNBC with extracellular vesicles carrying the ER will convert the tumor to ER+ and render it sensitive to treatment with SERMs including Atossa's proprietary (Z)-endoxifen.
- FD/MAS AlliancecoreCollaboration with the FD/MAS Alliance (Fibrous Dysplasia/McCune-Albright Syndrome) patient advocacy group and clinical researchers at Children's Hospital of Philadelphia to advance clinical development for McCune-Albright Syndrome. Atossa participated in a research priorities workshop with clinicians, researchers, and patient advocates to define development pathways.
Scale indicators9 records
Recent moves7 records
Expansion highlights5 records
Atossa Therapeutics competitors and assessment
Company assessmentDirect peers
- Olema Oncology: Olema Oncology is developing palazestrant (OP-1250), an oral SERD for ER+ breast cancer, including in ESR1-mutated settings. Direct competitor to (Z)-endoxifen in the next-generation oral SERD/SERM space for endocrine-resistant breast cancer with similar target patient population and clinical-stage development profile.
Broad incumbents
- Eli Lilly: Eli Lilly is developing imlunestrant (LY3484356), a next-generation oral SERD for ER+ breast cancer. As a large-cap pharmaceutical incumbent, Lilly has substantially greater resources for Phase 3 development and commercialization, and imlunestrant competes directly in the ESR1-mutant setting that (Z)-endoxifen targets.
- AstraZeneca: AstraZeneca is developing camizestrant (AZD9833), a next-generation oral SERD for ER+ breast cancer, and has established leadership in the breast cancer space through fulvestrant (FASLODEX). Represents a well-capitalized competitor with overlapping clinical programs in endocrine-resistant breast cancer.
- Menarini Group: Menarini Group acquired Stemline Therapeutics and markets elacestrant (ORSERDU), the first FDA-approved oral SERD for ER+/HER2- breast cancer with ESR1 mutations. Direct competitor with already-approved product in the same ESR1-mutant segment that (Z)-endoxifen targets.
- Roche: Roche/Genentech markets fulvestrant (FASLODEX), the first-in-class SERD for ER+ breast cancer, and has a deep breast cancer portfolio. While fulvestrant is injectable (not oral), Roche represents the established incumbent in endocrine therapy with substantially greater resources for combination trials and label expansion.
Emerging players
- Arvinas: Arvinas is developing vepdegestrant (ARV-471) in partnership with Pfizer, an estrogen receptor-targeting PROTAC degrader for ER+ breast cancer. Represents next-generation ER-targeting approach with potential overlap in endocrine-resistant populations; clinical-stage peer with novel mechanism.
- Zentalis Pharmaceuticals: Zentalis Pharmaceuticals was developing ZN-c5, an oral SERD for ER+ breast cancer, before restructuring its oncology pipeline. Direct peer in the oral SERD clinical development space, though Zentalis has shifted strategic focus. Comparable clinical-stage small-cap profile.
- Puma Biotechnology: Puma Biotechnology markets neratinib (NERLYNX) for HER2-positive breast cancer and has explored expanded indications. Small-cap breast cancer-focused company with similar market cap profile to Atossa and comparable commercial-stage challenges in oncology.
- Radius Health: Radius Health previously developed elacestrant (now owned by Menarini) and has experience in SERD clinical development. Represents historical precedent in the oral SERD space and offers comparable small-cap biotech profile that eventually exited via acquisition.
- Veru Inc. Veru Inc. is a clinical-stage biopharmaceutical company with oncology programs in prostate and breast cancer, including enobosarm for AR+ ER+ breast cancer. Comparable small-cap profile with multiple oncology indications in development, though focused on different mechanism (SARM).
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Atossa Therapeutics social profiles
Digital presenceAtossa Therapeutics compliance and trust
Trust signalCompliance3 records
Atossa Therapeutics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Atossa Therapeutics leadership team
Management profileNumber of profiles
Profiles7 records
Atossa Therapeutics funding detail
Funding detailFunding overview
Funding rounds6 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Atossa Therapeutics 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 Atossa Therapeutics
What does Atossa Therapeutics do?
Atossa Therapeutics is a clinical-stage biopharmaceutical company developing (Z)-endoxifen, a proprietary oral selective estrogen receptor modulator and degrader (SERM/SERD) formulated in an enteric capsule. The drug is being advanced through multiple Phase 2 clinical trials for breast cancer (metastatic, neoadjuvant, ductal carcinoma in situ, and breast density reduction) and rare diseases (Duchenne Muscular Dystrophy, McCune-Albright Syndrome, and potentially glioblastoma). All candidates are investigational, with no approved products or commercial revenue.
Is Atossa Therapeutics a public or private company?
Atossa Therapeutics is a public company. It is classified as public and is currently operating.
When was Atossa Therapeutics founded?
Atossa Therapeutics was founded in 2009. It employs 11 to 50 people.
Where is Atossa Therapeutics based?
Atossa Therapeutics is headquartered in Seattle, United States, in the North America region.
How does Atossa Therapeutics make money?
Three revenue lines are on record. No Commercial Revenue is the primary driver. The others are potential Future Product Revenue and priority Review Voucher (PRV).
Who are Atossa Therapeutics's main competitors?
Olema Oncology is listed as a direct peer. Broad incumbents are Eli Lilly, AstraZeneca, Menarini Group and Roche. Emerging players are Arvinas, Zentalis Pharmaceuticals, Puma Biotechnology, Radius Health and Veru Inc..
Does Atossa Therapeutics have an API?
No public API is recorded for Atossa Therapeutics.
What industry is Atossa Therapeutics in?
Atossa Therapeutics's product category is Oncology Pharmaceuticals. Its primary akta.pro industry code is HLAIAAAC, Oncology & Hematology Pharmaceuticals, with a secondary code of HLAIACAA, Oncology Specialty Pharmaceuticals. Its NAICS code is 325412 and its SIC code is 2834.