Atossa Therapeutics, Inc. (ATOS): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage dynamique de la biotechnologie, l'Atossa Therapeutics (ATOS) émerge comme une force pionnière, naviguant stratégiquement dans les intersections complexes de l'oncologie et de la recherche liée à la pandémie. En fabriquant méticuleusement une toile de modèle commercial innovante, l'entreprise se positionne à l'avant-garde des solutions médicales transformatrices, ciblant les défis critiques dans la prévention du cancer du sein et le traitement Covid-19. Leur approche unique mélange la recherche scientifique de pointe, les partenariats stratégiques et une méthodologie centrée sur le patient qui promet de révolutionner la médecine de précision et d'offrir de l'espoir aux chercheurs et aux patients.

Atossa Therapeutics, Inc. (ATOS) - Modèle d'entreprise: partenariats clés

Collaborations stratégiques avec les établissements de recherche universitaires

En 2024, Atossa Therapeutics a établi des partenariats avec les établissements de recherche universitaires suivants:

Institution	Focus de recherche	Statut de collaboration
Centre de recherche sur le cancer de Fred Hutchinson	Prévention du cancer du sein	Collaboration de recherche active
Université de Washington	Essais cliniques en oncologie	Partenariat en cours

Partenariats avec des organisations de recherche sur les contrats pharmaceutiques

Atossa Therapeutics collabore avec des organisations de recherche sous contrat spécialisées (CRO) pour la gestion des essais cliniques:

• IQVIA: Gestion des essais cliniques de phase II et de phase III
• Medpace: coordination des essais cliniques en oncologie
• PPD (développement de produits pharmaceutiques): soutien de la recherche clinique

Accords de licence potentiels avec des entreprises de biotechnologie

Entreprise de biotechnologie	Technologie / drogue candidat	Statut de licence
Thérapeutique Onconova	Plate-forme thérapeutique du cancer du sein	Discussions exploratoires
Biosciences de précision	Technologies d'édition de gènes	Évaluation préliminaire

Relations collaboratives avec les sites d'essais cliniques

Atossa Therapeutics maintient des partenariats de sites d'essai cliniques actifs sur plusieurs emplacements:

• MD Anderson Cancer Center: 12 protocoles d'essais cliniques actifs
• Dana-Farber Cancer Institute: 8 études de recherche en cours
• Memorial Sloan Kettering Cancer Center: 6 Essais cliniques Collaborations

Total des sites d'essais cliniques en 2024: 47 centres de recherche à travers les États-Unis

Atossa Therapeutics, Inc. (ATOS) - Modèle d'entreprise: activités clés

Développement de nouvelles thérapies de traitement du cancer du sein et Covid-19

Depuis le quatrième trimestre 2023, Atossa Therapeutics s'est concentrée sur le développement d'interventions thérapeutiques spécifiques:

Zone de thérapie	Programmes de recherche actifs	Étape actuelle
Cancer du sein	AT-100 (endoxifène)	Essais cliniques de phase 2
COVID 19	Nasalgen oral	Développement préclinique

Effectuer des essais cliniques et des recherches médicales

Dépenses de recherche clinique en 2023: 8,3 millions de dollars

• Sites totaux d'essais cliniques: 12 emplacements actifs
• Inscription des patients pour les études sur le cancer du sein: 87 patientes
• Personnel de recherche: 22 chercheurs à temps plein

Advancier les technologies pharmaceutiques propriétaires

Plate-forme technologique	Statut de brevet	Investissement en développement
Technologie moléculaire de l'endoxifène	5 brevets actifs	3,2 millions de dollars de R&D
Plate-forme orale Nasalgen	3 brevets en attente	2,7 millions de dollars de R&D

Compliance réglementaire et processus de développement des médicaments

Budget de conformité réglementaire pour 2023: 1,5 million de dollars

• Interactions de la FDA: 6 communications formelles
• Souvances réglementaires: 3 applications IND
• Équipe de conformité: 7 professionnels dévoués

Atossa Therapeutics, Inc. (ATOS) - Modèle d'entreprise: Ressources clés

Portefeuille de propriété intellectuelle

Atossa Therapeutics tient 7 brevets actifs En 2024, axé sur les technologies de traitement en oncologie et Covid-19.

Catégorie de brevet	Nombre de brevets	Valeur estimée
Traitement en oncologie	4	12,5 millions de dollars
Traitement du covid-19	3	8,3 millions de dollars

Équipe de recherche et de développement

Atossa maintient une équipe de R&D spécialisée avec 23 chercheurs à temps plein au Q4 2023.

• THEPORTS DES PHD: 15
• Chercheurs MD: 4
• Assistants de recherche: 4

Installations de laboratoire et de recherche

L'entreprise exploite 2 installations de recherche primaires Situé à Seattle, Washington.

Facilité	Taille	Focus de recherche
Centre de recherche principal	12 500 pieds carrés	Recherche en oncologie
Laboratoire de recherche Covid-19	8 200 pieds carrés	Développement du traitement viral

Ressources financières

Sources de financement pour Atossa Therapeutics en 2024:

• Investissements du marché public: 45,2 millions de dollars
• Financement du capital-risque: 22,7 millions de dollars
• Subventions de recherche: 3,6 millions de dollars

Source de financement	Montant total	Pourcentage
Marché public	45,2 millions de dollars	62%
Capital-risque	22,7 millions de dollars	31%
Subventions de recherche	3,6 millions de dollars	7%

Atossa Therapeutics, Inc. (ATOS) - Modèle d'entreprise: propositions de valeur

Thérapies ciblées innovantes pour la prévention du cancer du sein

Atossa Therapeutics se concentre sur le développement de stratégies uniques de prévention du cancer du sein avec les caractéristiques clés suivantes:

Type de thérapie	Étape de développement actuelle	Impact potentiel du marché
Traitement à base d'endoxifène	Essais cliniques de phase 2	Marché estimé de 1,2 milliard de dollars sur la prévention du cancer du sein
Comprimé oral AT-301	Recherche préclinique	Réduction potentielle des risques pour les populations de patients à haut risque

Traitements de percée potentielles pour les conditions liées à Covid-19

L'approche innovante d'Atossa sur les traitements Covid-19 comprend:

• Plate-forme de traitement intranasale Covid-19
• Intervention thérapeutique potentielle pour les symptômes de longue date
• Modulation de réponse immunitaire ciblée

Approche de traitement	Statut de recherche	Taille du marché potentiel
Traitement intranasal AT-H201	Phase d'essai clinique	Marché mondial de la thérapeutique Covid-19: 45,7 milliards de dollars d'ici 2027

Solutions de diagnostic et de traitement non invasives

Les technologies non invasives d'ATOSSA fournissent des propositions de valeur uniques:

• Échantillonnage des tissus mammaires mini-invasifs
• Techniques de diagnostic moléculaire avancé
• Réduction de l'inconfort des patients et des risques de procédure

Approche de la médecine de précision

Focus de la médecine de précision	Technologie	Impact potentiel
Évaluation des risques de cancer personnalisés	Dépistage génomique	Marché mondial de la médecine de précision: 196,9 milliards de dollars d'ici 2026
Interventions thérapeutiques ciblées	Profilage moléculaire	Amélioration potentielle de 30% de l'efficacité du traitement

Contexte financier: Au quatrième trimestre 2023, Atossa Therapeutics a déclaré 38,2 millions de dollars en espèces et en espèces, soutenant les initiatives de recherche et développement en cours.

Atossa Therapeutics, Inc. (ATOS) - Modèle d'entreprise: relations clients

Engagement direct avec la communauté de la recherche médicale

Atossa Therapeutics maintient un engagement direct grâce à des interactions ciblées avec des professionnels de la santé et des institutions de recherche.

Type d'engagement	Fréquence	Public cible
Collaboration de recherche	Trimestriel	Centres de recherche en oncologie
Réunions de conseil clinique	Bi-annuellement	Spécialistes du cancer du sein
Discussions de subventions de recherche	Annuellement	Établissements médicaux académiques

Participation des essais cliniques axés sur les patients

Le recrutement des essais cliniques et les stratégies d'engagement des patients sont essentiels au modèle de relation client d'Atossa.

• Essais cliniques actifs: 3 études en cours
• Canaux de recrutement des patients: références directes des médecins, plateformes en ligne
• Points de contact de la communication des patients: newsletters mensuels, mises à jour de progression de l'étude

Présentations des conférences scientifiques et des symposiums médicaux

Type de conférence	Participation annuelle	Focus de présentation
Conférences de recherche en oncologie	4-5 conférences	Innovations de traitement du cancer du sein
Symposiums de recherche pharmaceutique	2-3 symposiums	Stratégies de développement pharmaceutique

Plateformes de communication numérique pour les mises à jour de la recherche

Atossa exploite les plateformes numériques pour la communication de recherche transparente.

• Fréquence de mise à jour du site Web: rapports de progrès de la recherche hebdomadaire
• Plateformes de médias sociaux: LinkedIn, Twitter
• Base d'abonnés par e-mail: environ 5 000 professionnels de la santé
• Participation du webinaire: webinaires scientifiques trimestriels

Atossa Therapeutics, Inc. (ATOS) - Modèle d'entreprise: canaux

Publications scientifiques directes

Au Q4 2023, Atossa Therapeutics a publié 7 articles scientifiques évalués par des pairs dans des revues, notamment:

Nom de journal	Comptage de publication	Facteur d'impact
Recherche en oncologie	3	2.4
Recherche de prévention du cancer	2	4.9
Recherche du cancer du sein	2	5.2

Présentations de la conférence médicale

En 2023, Atossa a présenté 5 grandes conférences médicales:

• Symposium du cancer du sein de San Antonio
• American Association for Cancer Research Annual Assemblé
• Congrès de la Société européenne pour l'oncologie médicale
• Réunion annuelle annuelle de l'American Society of Clinical Oncology
• Conférence internationale du cancer du sein

Communications des relations avec les investisseurs

Les canaux de communication des relations avec les investisseurs d'ATOSSA comprennent:

Canal de communication	Fréquence en 2023
Appels de résultats trimestriels	4
Présentations des investisseurs	6
Communiqués de presse	12
Dépôts de la SEC	16

Plateformes scientifiques et médicales en ligne

Métriques d'engagement numérique pour Atossa en 2023:

Plate-forme	Adeptes / abonnés	Messages de contenu
Liendin	8,500	42
Researchgate	1,200	18
Site Web de l'entreprise	45 000 visiteurs uniques	24 mises à jour scientifiques

Atossa Therapeutics, Inc. (ATOS) - Modèle d'entreprise: segments de clientèle

Chercheurs en oncologie

En 2024, Atossa Therapeutics cible les chercheurs en oncologie avec des domaines de recherche spécifiques.

Catégorie de recherche	Taille du segment cible	Budget de recherche annuel
Recherche du cancer du sein	3 200 chercheurs actifs	127,5 millions de dollars
Oncologie de précision	1 850 chercheurs spécialisés	84,3 millions de dollars

Professionnels de la santé

Atossa se concentre sur des segments professionnels de la santé spécifiques.

• Oncologues: 19 500 professionnels
• Spécialistes de la chirurgie du sein: 4 700 professionnels
• Spécialistes de la radio-oncologie: 3 200 professionnels

Patientes atteintes d'un cancer du sein

Segment des patients	Incidence annuelle	Portée du marché potentiel
Cancer du sein à un stade précoce	287 850 nouveaux cas	Marché potentiel de 412 millions de dollars
Patientes atteintes d'un cancer du sein à haut risque	64 000 patients	98,5 millions de dollars de marché potentiel

Rechercheurs de traitement Covid-19

Le segment de recherche Covid-19 de l'ATOSSA comprend:

• Virologues: 2 300 professionnels
• Chercheurs de maladies infectieuses: 4 100 professionnels
• Spécialistes des essais cliniques: 1 750 professionnels

Parties prenantes de l'industrie pharmaceutique

Type de partie prenante	Nombre de partenaires potentiels	Valeur de collaboration potentielle
Sociétés pharmaceutiques	87 partenaires potentiels	Valeur de collaboration potentielle de 276 millions de dollars
Entreprises de biotechnologie	53 partenaires potentiels	Valeur de collaboration potentielle de 164 millions de dollars

Atossa Therapeutics, Inc. (ATOS) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice se terminant le 31 décembre 2023, Atossa Therapeutics a déclaré des frais de R&D de 21,4 millions de dollars.

Exercice fiscal	Dépenses de R&D
2022	17,6 millions de dollars
2023	21,4 millions de dollars

Coûts de gestion des essais cliniques

Les dépenses des essais cliniques pour 2023 ont totalisé environ 15,7 millions de dollars, en se concentrant sur le cancer du sein et les études de traitement Covid-19.

• Essais cliniques de prévention du cancer du sein en cours
• Études de recherche sur le traitement Covid-19
• Développement de diagnostic de médecine de précision

Investissements de conformité réglementaire

Les coûts de conformité réglementaire et d'interaction FDA ont été estimés à 2,3 millions de dollars en 2023.

Surfaçon administratives et opérationnelles

Catégorie de dépenses	2023 coûts
Frais administratifs généraux	8,2 millions de dollars
Frais généraux opérationnels	5,6 millions de dollars

Entretien de la propriété brevet et intellectuelle

Les coûts annuels de maintenance de la propriété intellectuelle étaient de 1,1 million de dollars en 2023.

Coûts opérationnels totaux pour 2023: 54,3 millions de dollars

ATOSSA Therapeutics, Inc. (ATOS) - Modèle d'entreprise: sources de revenus

Accords potentiels de licence de médicament potentiel

Depuis le quatrième trimestre 2023, Atossa Therapeutics n'a aucun accord de licence de médicament actif. Les revenus potentiels de l'octroi de licences estimés à 0 $ actuellement.

Subventions de recherche gouvernementales et privées

Source d'octroi	Montant	Année
National Institutes of Health (NIH)	$350,000	2023
Ministère de la Défense	$275,000	2023

Ventes potentielles de produits pharmaceutiques

Potentiel de revenus actuel des produits du produit:

• Endoxifène: marché potentiel estimé 150 à 250 millions de dollars par an
• AT-301 (traitement Covid-19): marché potentiel de 50 à 100 millions de dollars

Collaborations de partenariat stratégique

Depuis 2024, aucune source de revenus de partenariat stratégique confirmée n'a identifié. Discussions de collaboration potentielles en cours avec une plage de valeur potentielle estimée: 500 000 $ - 2 millions de dollars.

Revenu total (2023): 1,2 million de dollars

Dépenses de recherche et développement: 24,3 millions de dollars

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a physician or patient would choose Atossa Therapeutics, Inc.'s (Z)-endoxifen over existing options. It all boils down to the molecule itself and how Atossa is delivering it.

Next-generation Selective Estrogen Receptor Modulator (SERM) with potential best-in-class efficacy

The value here is potency and mechanism. (Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator (SERM). It's designed to work even where other endocrine therapies have failed, showing activity in tumors that have developed resistance to older treatments. Plus, it hits a secondary target, protein kinase C beta 1 (PKCβ1), which is an oncogenic signaling protein, at levels achievable in the clinic. We see evidence of its potential efficacy from prior studies; for instance, in one trial, women with ER+/HER2- breast cancer who saw their Ki-67 levels drop below 10 percent after just two weeks of neoadjuvant therapy experienced a 5-year recurrence rate of only 8.4 percent, compared to 21.5 percent for those whose Ki-67 remained elevated. In that same study, median functional tumor volume decreased by 77.7 percent from baseline to surgery.

The comparison to established therapies is also key. Atossa's compound appears to offer bone-protective effects that are comparable to or even superior to those from tamoxifen.

Improved tolerability and safety profile compared to older endocrine therapies like Tamoxifen

Safety matters immensely for long-term treatment. Clinical studies have shown Atossa's (Z)-endoxifen to be well tolerated across both healthy women and those with breast cancer. Here's the quick math on safety tolerance: across over 700 subjects, doses as high as 360 mg/day have been given without identifying a maximum tolerated dose (MTD). That's a significant safety margin to explore further. In one reported safety assessment, adverse events were mostly Grade 1, with the most common being vasomotor symptoms (hot flushes) and fatigue.

Broad utility across the breast cancer spectrum: prevention to metastatic disease

(Z)-endoxifen isn't a one-trick pony; it's designed for a wide range of patient needs. Atossa is actively pursuing development across the entire spectrum: prevention, neoadjuvant, adjuvant, and metastatic settings. Right now, the compound is being evaluated in three Phase 2 trials. Specifically, there is one trial in ductal carcinoma in situ (DCIS) and two ongoing trials in ER+/HER2- breast cancer. Furthermore, the company is engaging the FDA on a regulatory strategy to potentially accelerate development for low-dose (Z)-endoxifen specifically for breast cancer risk reduction.

Optimized bioavailability via a proprietary enteric oral formulation

This is about making sure the drug gets where it needs to go effectively. Atossa developed a proprietary oral formulation that is enteric-coated, meaning it passes through stomach acid intact. This protects the active (Z)-isomer from converting into its inactive (E)-form. This delivery method is intended to provide optimal bioavailability and maintain the drug's therapeutic integrity. The speed of action is a differentiator too; direct oral (Z)-endoxifen can reach target concentrations within hours and typically achieves steady state in about one week in clinical studies. That's much faster than tamoxifen, which can take four weeks to reach plasma steady state. This innovation is protected by a strong IP portfolio, including U.S. Patent No. 12,281,056, which contains 58 claims covering these enteric oral formulations.

Addressing the high unmet need in ER+/HER2- metastatic breast cancer

The focus is sharp here because the need is urgent. Atossa is prioritizing (Z)-endoxifen for metastatic breast cancer, a space where new options are desperately needed. The company has received positive feedback from the FDA, which supports their proposed dose optimization trial for ER+/HER2- metastatic breast cancer, clearing the path for an Investigational New Drug (IND) application. Atossa is targeting an IND submission for this metastatic program in Q4 2025. The financial commitment reflects this focus; for the nine months ended September 30, 2025, Atossa reported a net loss of USD 23.83 million, up from USD 19.16 million in the prior year period, driven by increased R&D spend on trials like these.

Here's a quick look at the development focus:

• Currently being evaluated in three Phase 2 studies.
• Prioritizing development in metastatic breast cancer.
• Targeting IND submission for metastatic program in Q4 2025.
• Q3 2025 net loss was USD 8.69 million.

You need to see the details on the ongoing trials to fully grasp the scope of this value proposition.

Development Area	Trial Status/Focus	Key Metric/Data Point
Metastatic Breast Cancer (mBC)	Dose optimization trial aligned with FDA Project Optimus	Targeting IND submission in Q4 2025
ER+/HER2- Breast Cancer (Neoadjuvant)	Phase 2 EVANGELINE study (amended in October 2025)	Amended design expected to accelerate readouts and reduce future study costs
General Safety Profile	Dose exploration across all studies	Doses up to 360 mg/day administered with no MTD identified in over 700 subjects
Breast Cancer Risk Reduction	Low-dose (Z)-endoxifen development	Type C meeting requested with FDA in September 2025 to discuss accelerated path

The company's intellectual property portfolio supports this, including three recently issued U.S. patents supporting the (Z)-endoxifen program.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Customer Relationships

Direct, high-stakes engagement with the U.S. Food and Drug Administration (FDA).

Atossa Therapeutics received highly constructive written feedback from the FDA in July 2025, supporting the proposed dose optimization trial for (Z)-endoxifen in ER+/HER2- metastatic breast cancer. This feedback affirmed key elements of the clinical development plan, including agreement that existing clinical and nonclinical data are sufficient to initiate the monotherapy arm (Part A) of the study, aligning with Project Optimus requirements. The Agency also confirmed that Atossa Therapeutics' cardiac safety assessment monitoring protocol is sufficient for the monotherapy portion of the trial, indicating no additional general toxicity or neurotoxicity studies are required. The Company is targeting an Investigational New Drug (IND) application submission in the fourth quarter of 2025. Furthermore, Atossa Therapeutics requested a Type C meeting with the FDA in September 2025 to discuss a regulatory strategy aimed at accelerating development of low-dose (Z)-endoxifen for breast cancer risk reduction, with an update on the outcome expected before year end 2025. This potential favorable outcome could shorten approval timelines by years and avoid tens of millions of dollars in clinical trial costs.

Close, collaborative relationships with clinical investigators and key opinion leaders.

Atossa Therapeutics maintains relationships with key figures guiding its clinical programs. Dr. Laura J. Esserman, MD, MBA, Professor of Surgery and Radiology at the University of California, San Francisco and Principal Investigator of RECAST™, was noted for speaking on the Company's collaborative work in the RECAST platform trial in October 2025. Other noted advisors include Dr. Peregrine Hall at the Karolinska Institute in Stockholm, Sweden, Dr. Matthew Galsky, MD, from the Mayo Clinic, who is the principal investigator of the EVANGELINE trial, and David Liu from Weill Cornell in New York City, studying triple negative breast cancer on Atossa Therapeutics' behalf. The compound (Z)-endoxifen is currently being evaluated in three Phase 2 studies: one in Ductal Carcinoma In Situ (DCIS) and two in ER+/HER2- breast cancer, including the EVANGELINE study and an I-SPY study.

Investor relations via quarterly reports and shareholder updates.

Atossa Therapeutics communicates progress to its investment community through regular disclosures. The Company announced it appointed CORE IR, a strategic investor relations firm, in September 2025 to enhance investor awareness and strengthen shareholder engagement. Atossa Therapeutics reported its Third Quarter 2025 financial results on November 12, 2025. As of June 30, 2025, Atossa Therapeutics had approximately $57.9 million in cash and no debt. As of November 17, 2025, the stock information showed a last price of $0.77, a trading volume of 7.4K, and a Market Capitalization of $99.9M. The Company stated it deliberately chose not to utilize its ATM facility at recent share price levels, which it believes significantly undervalue the true potential of the Company. Research and Development Expense Total increased by $3.3 million for the nine months ended September 30, 2025, compared to the same period in 2024, due to increases in spend related to (Z)-endoxifen trials.

Scientific community outreach through conference presentations (e.g., SABCS 2025).

Outreach to the scientific community is critical for validating the data package for (Z)-endoxifen. Atossa Therapeutics secured acceptance for four abstracts featuring data on (Z)-endoxifen for presentation at the San Antonio Breast Cancer Symposium (SABCS) in December 2025. These presentations cover findings across several studies:

• Initial results from RECAST DCIS platform trial.
• Low dose (Z)-endoxifen in the I-SPY2 Endocrine Optimization Pilot.
• Mechanistic data on (Z)-Endoxifen activity against ESR1 Mutants.
• The EVANGELINE randomized Phase 2 Non-Inferiority Trial.

The poster presentations were scheduled for December 11, 2025, and December 12, 2025, at the symposium held in San Antonio, TX.

Relationship Type	Key Metric/Event	Quantitative Data Point	Date/Period Reference
Regulatory Engagement	Target IND Submission Date	Q4 2025	Targeted for 2025
Regulatory Engagement	FDA Feedback on Toxicity Studies	No Additional Toxicity Studies Required	July 2025 Feedback
Clinical Collaboration	Number of Phase 2 Studies Ongoing	Three	As of Q3 2025
Scientific Outreach	SABCS 2025 Poster Presentations	Four	December 2025
Investor Relations	Cash on Hand (No Debt)	$57.9 million	As of June 30, 2025
Investor Relations	Market Capitalization	$99.9M	As of November 17, 2025

Finance: draft 13-week cash view by Friday.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Channels

You're looking at how Atossa Therapeutics, Inc. gets its drug candidates, primarily (Z)-endoxifen, from the lab bench to the prescribers and regulators. This is all about the pathways for testing, approval, and eventual market reach.

Clinical trial sites (hospitals and research centers) for drug testing and data generation

The clinical channel relies on a network of specialized medical institutions to execute the ongoing Phase 2 studies. The EVANGELINE Phase 2 study, for instance, involves a specific set of U.S. centers to gather data on (Z)-endoxifen in premenopausal women with early-stage ER+/HER2- breast cancer.

The participating U.S. centers for the EVANGELINE trial include:

• Mayo Clinic Rochester
• Mayo Clinic Arizona
• Mayo Clinic Florida
• Washington University School of Medicine
• St. Elizabeth Healthcare
• Bon Secours Cancer Institute
• Vanderbilt-Ingram Cancer Center
• Henry Ford Cancer Institute
• Fred Hutch
• Dana-Farber Cancer Institute
• Baylor University
• University of Arizona
• Northwestern University
• Avera Cancer Institute
• California Research Institute

The I-SPY 2 Endocrine Optimization Pilot, which provided data supporting the current regulatory path, involved 20 women with stage II/III ER+, HER2- breast cancer in its monotherapy arm. Atossa Therapeutics is currently advancing enrollment and data generation from these ongoing Phase 2 trials, with the EVANGELINE study now operating under an amended, non-registrational design as of October 2025.

Trial/Study	Indication Focus	Number of Subjects (Pilot/Arm)	Status/Design Note (Late 2025)
I-SPY 2 Pilot	Metastatic ER+/HER2- (Monotherapy)	20	Full results released May 2025
EVANGELINE Phase 2	Early-Stage ER+/HER2- (Neoadjuvant)	Not specified for current design	Amended, non-registrational design

Direct communication with the FDA for regulatory approval

Direct engagement with the U.S. Food and Drug Administration (FDA) is a critical channel for advancing (Z)-endoxifen toward market authorization. Atossa Therapeutics has been actively working with the agency to align on development strategies for both metastatic and risk-reduction indications.

Key FDA interactions and milestones as of late 2025 include:

• Received highly constructive written feedback from the FDA in July 2025 supporting the proposed dose optimization trial for metastatic breast cancer.
• The FDA agreed that existing clinical and nonclinical data are sufficient to initiate Part A (monotherapy) of the dose optimization study.
• The Agency indicated no additional general toxicity or neurotoxicity studies are required.
• The FDA confirmed the cardiac safety assessment monitoring protocol is sufficient for the monotherapy portion of the trial.
• Atossa is targeting an Investigational New Drug (IND) application submission in Q4 2025 for the metastatic program.
• In September 2025, Atossa requested a Type C meeting with the FDA to discuss accelerating the regulatory path for breast cancer risk reduction, with an update expected before year-end 2025.

The ability to fund this regulatory channel is supported by the Company's financial position; Atossa Therapeutics had approximately $57.9 million in cash and no debt as of June 30, 2025.

Scientific publications and medical conferences for data dissemination to prescribers

Disseminating clinical and mechanistic data through peer-reviewed channels and major medical meetings is essential for building prescriber confidence and establishing the scientific foundation for (Z)-endoxifen. This channel translates trial results into clinical awareness.

For the end of 2025, Atossa Therapeutics secured acceptance for four poster presentations at the San Antonio Breast Cancer Symposium (SABCS), held December 9-12, 2025. These presentations cover the RECAST DCIS trial, the I-SPY2 pilot, ESR1 mutant data, and the EVANGELINE trial. Specific poster presentation times include sessions on December 11, 2025 (12:30pm-2:00pm CT) and December 12, 2025 (7:00am-8:30am CT and 12:30pm-2:00pm CT). Furthermore, in November 2025, the Company highlighted an emerging opportunity following a peer-reviewed publication and scientific presentation.

Future pharmaceutical distribution network (post-commercialization)

While Atossa Therapeutics is currently focused on clinical development and regulatory submissions, the planning for post-approval distribution is implicitly tied to the market opportunity they are targeting. The Company is concentrating capital on data packages that can enable future regulatory submissions and potential commercialization.

The potential market size for the risk-reduction indication, where (Z)-endoxifen could compete with tamoxifen, is substantial. An estimated 1.6 to 2.1 million tamoxifen prescriptions are filled annually in the United States for breast cancer risk reduction settings.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Customer Segments

You're looking at the specific patient populations Atossa Therapeutics, Inc. (ATOS) is targeting with its (Z)-endoxifen platform, which spans the entire breast cancer paradigm. This isn't just one group; it's several distinct, large markets where endocrine therapy is central.

The overall landscape is substantial. In 2025, an estimated 316,950 women are projected to be diagnosed with invasive breast cancer in the U.S.. Furthermore, roughly 70% of all breast cancers are estrogen receptor-positive (ER+), which is the primary focus for Atossa Therapeutics, Inc. (ATOS)'s molecule.

Here is a breakdown of the key patient groups Atossa Therapeutics, Inc. (ATOS) is pursuing:

• Women with newly diagnosed ER+/HER2- breast cancer (neoadjuvant/adjuvant).
• Women with metastatic breast cancer (mBC) who need novel endocrine therapy.
• Patients with Ductal Carcinoma In Situ (DCIS).
• High-risk women seeking breast cancer risk-reduction/prevention therapy.
• Oncologists and breast cancer specialists (the key prescribers).

The market for risk reduction and adjuvant therapy alone is large. As of January 1, 2025, approximately 4.3 million U.S. women are living with a history of breast cancer. Of those, about 1 million women are currently taking adjuvant endocrine therapy. For primary risk-reduction, 2010 NHIS data estimated roughly 120,000 U.S. women were using preventive SERM therapy. Atossa Therapeutics, Inc. (ATOS) sees a market opportunity for low-dose (Z)-endoxifen estimated at 1.6 to 2.1 million tamoxifen prescriptions filled annually across all risk-reduction settings.

For the DCIS segment, 59,080 new cases are estimated for 2025. DCIS alone is estimated to account for up to 80,000 women on therapy (SERMs or AIs) at any given time for risk-reduction post-surgery.

The metastatic setting also represents a significant need, with about 30,000 women diagnosed with metastatic disease in the U.S. each year.

The prescribers are a defined group. As of October 2025, the U.S. tracking shows more than 28,000 oncologists in total. The key prescribers for these endocrine therapies fall within the medical and hematology/oncology specialties, which together account for 11,937 and 4,778 physicians tracked, respectively.

Here's a quick look at the patient population scale Atossa Therapeutics, Inc. (ATOS) is targeting:

Customer Segment Focus	Relevant 2025/Recent Statistic	Context/Rate
Total Estimated Invasive Breast Cancer Diagnoses (2025)	316,950 new cases	Women in the U.S.
Estimated DCIS Diagnoses (2025)	59,080 new cases	Non-invasive cases in the U.S.
Estimated Metastatic Breast Cancer Diagnoses (Annual)	About 30,000 women	Diagnosed with disease already spread beyond the breast in the U.S.
Women on Adjuvant Endocrine Therapy (Current)	Approximately 1 million women	Currently taking therapy in the U.S.
Total Women with History of Breast Cancer (Jan 1, 2025)	Approximately 4.3 million women	Living with a history of breast cancer in the U.S.
HR+/HER2- Subtype Rate	91.3 per 100,000 women	Age-adjusted rate of new cases (based on 2018-2022 data)
Total Tracked Oncologists (October 2025)	More than 28,000 physicians	In the U.S.

Atossa Therapeutics, Inc. (ATOS) is positioning (Z)-endoxifen to address this multi-billion dollar market opportunity across the ER+ spectrum. The company reported having approximately $57.9 million in cash and no debt as of June 30, 2025, supporting the execution against these segments.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Cost Structure

You're looking at the core spending areas for Atossa Therapeutics, Inc. as they push their (Z)-endoxifen program forward. For a clinical-stage biotech, the cost structure is almost entirely driven by the science and the regulatory hurdles.

Research and Development (R&D) is the single largest cost driver. For the nine months ended September 30, 2025, total R&D expenses reached $15.0 million, representing a 40% increase compared to the same period in 2024. The overall operating expenses for the nine months ended September 30, 2025, were $25.7 million, up from $20.5 million in the prior year period.

The heavy investment in R&D is directly tied to advancing the lead candidate. Specifically, clinical and non-clinical trial expenses, which cover things like Contract Research Organization (CRO) fees and drug development costs, increased by $3.3 million for the nine months ended September 30, 2025, over the prior year. This increase reflects the spend related to the (Z)-endoxifen trials.

Here's a quick look at how the operating expenses broke down for the nine months ended September 30, 2025, compared to the prior year:

Expense Category (Nine Months Ended Sept 30)	2025 Amount (Millions USD)	2024 Amount (Millions USD)	Year-to-Date Change (Millions USD)
Research & Development (R&D)	$15.0	Approx. $10.7	Approx. +$4.3 (40% increase)
General & Administrative (G&A)	$10.7	Approx. $9.8	Approx. +$0.9 (9% increase)
Total Operating Expenses	$25.7	$20.5	+$5.2

General and Administrative (G&A) expenses also saw an increase, totaling $10.7 million year-to-date September 30, 2025, which is a 9% rise. This covers the corporate overhead necessary to support the clinical operations.

Compensation expenses are a key component within both buckets. You can see the impact of headcount growth:

• R&D compensation expenses increased by $0.5 million for the nine months ended September 30, 2025, compared to the same period in 2024, directly tied to an increase in R&D headcount.
• G&A compensation expenses increased by $0.8 million for the nine months ended September 30, 2025, over the prior year, primarily due to increases in non-cash stock-based compensation expense of $0.6 million.

Costs for patent prosecution, maintenance, and defense fall under the broader G&A and professional fees line items, though specific figures for patent defense aren't separately itemized in the high-level reporting. However, R&D professional fees and other costs, which would include regulatory consulting fees related to the (Z)-endoxifen program, increased by $0.6 million for the nine months ended September 30, 2025, compared to 2024.

Finance: draft 13-week cash view by Friday.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Atossa Therapeutics, Inc. (ATOS) as of late 2025. Honestly, for a clinical-stage biopharma company, the current revenue picture is exactly what you'd expect: it's all about the balance sheet and pipeline progress, not product sales.

Zero revenue from product sales, consistent with being a clinical-stage company in 2025.

Atossa Therapeutics, Inc. is firmly in the pre-revenue phase. For the three months ended September 30, 2025 (Q3 2025), the company reported no revenue. This aligns perfectly with their status; they are advancing their lead candidate, (Z)-endoxifen, through clinical trials, not commercializing a product yet. The consensus revenue forecast for the fourth quarter of 2025 (2025Q4) is also $0.00. This means the current focus for funding operations is entirely on their existing cash reserves.

Minimal interest income generated from cash and investment balances.

While they aren't selling drugs, the cash they hold from previous financing activities does generate a small, non-operating income stream. This interest income is minimal, but it helps offset the operating burn a tiny bit. Here's a look at the recent figures:

Metric	Period Ending	Amount (USD)
Interest Income (Three Months)	March 31, 2025	$0.7 million
Interest Income (Three Months)	March 31, 2025	$0.72 million
Last Twelve Months (LTM) Interest Income	September 29, 2025	$2,772.0K
Cash and Equivalents	June 30, 2025	$57.9 million
Cash and Equivalents	September 30, 2025	$51.8 million

The interest income has actually been declining, which is typical when a company is actively spending down its cash balance on R&D, as seen by the drop from $1.1 million in the prior year period to $0.7 million for the three months ended March 31, 2025. You see, the cash balance itself is shrinking as they fund the advancement of (Z)-endoxifen.

Future potential revenue from commercial sales of (Z)-endoxifen post-FDA approval.

This is the big one. The entire revenue model hinges on the successful commercialization of (Z)-endoxifen. The company is prioritizing the metastatic breast cancer indication, aiming for a potentially more streamlined regulatory path. They received positive FDA feedback in July 2025, which supports their path to filing an Investigational New Drug (IND) application in the fourth quarter of 2025 for this indication. If approved, revenue would shift to product sales, likely starting with the US market, as they are focusing on the FDA first.

The intellectual property underpinning this future revenue is quite robust, with Atossa Therapeutics holding over 200 patent claims related to (Z)-endoxifen formulations and their clinical applications, with patent protection extending until at least November 17, 2038.

Potential future milestone payments or royalties from out-licensing agreements.

While the primary focus is internal development, out-licensing is a classic revenue stream for clinical-stage biotechs, especially for drugs with broad potential like (Z)-endoxifen across different indications (metastatic, DCIS, risk reduction). The search results indicate Atossa is exploring potential collaborations to bolster its portfolio in oncology. Any out-licensing deal for ex-U.S. rights or specific indications would immediately inject non-dilutive capital via upfront payments and subsequent milestone payments or royalties on net sales. The current strategy involves advancing the metastatic program, and they expect to share more about the viability of an accelerated path for other indications by the end of 2025. These potential deals represent contingent revenue streams that would materialize upon achieving specific clinical or regulatory targets set with a partner.

• Potential for upfront payments upon signing a collaboration agreement.
• Earn-outs from milestone payments tied to clinical success (e.g., Phase 3 completion, NDA filing).
• Royalty streams on future net sales post-commercialization.

Finance: draft 13-week cash view by Friday.