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

Dans le paysage complexe des thérapies pulmonaires, la thérapeutique aérovale émerge comme un phare d'innovation, transformant les défis respiratoires complexes en traitements percés potentiels. En tirant stratégiquement sa toile de modèle commercial unique, cette entreprise de biotechnologie pionnière redéfinit la façon dont les troubles pulmonaires sont rares, combinant des recherches de pointe avec des solutions thérapeutiques ciblées qui promettent de révolutionner les soins aux patients. Leur approche audacieuse s'étend sur des essais cliniques avancés, une infrastructure de recherche spécialisée et un engagement axé sur le laser à répondre aux besoins médicaux non satisfaits en médecine respiratoire, en positionnant l'aérovat comme un changeur de jeu potentiel dans le monde difficile des interventions rares de la maladie pulmonaire.

Aerovate Therapeutics, Inc. (AVTE) - Modèle d'entreprise: partenariats clés

Collaboration avec les établissements de recherche et les centres médicaux universitaires

Aerovate Therapeutics a établi des partenariats stratégiques avec les institutions de recherche suivantes:

Institution	Focus de la collaboration	Année établie
École de médecine de Harvard	Recherche de maladies pulmonaires	2022
Hôpital général du Massachusetts	Soutien en essai clinique	2021

Partenariats stratégiques avec les entreprises de développement pharmaceutique

Aerovate a développé des partenariats critiques de développement pharmaceutique:

• Icon PLC - Services de gestion des essais cliniques
• Parexel International - Collaboration de développement des médicaments
• IQVIA Holdings Inc. - Support de recherche et commercialisation clinique

Accords de licence potentiels avec des spécialistes du traitement des maladies pulmonaires

Partenaire	Statut de licence	Focus potentiel du médicament
Boehringer Ingelheim	Évaluation en attente	Thérapie hypertension pulmonaire
Belite Bio, Inc.	En négociation	Traitements de maladies pulmonaires rares

Engagement avec les sites d'essais cliniques et les réseaux de recherche

Le réseau d'essais cliniques d'Aerovate comprend:

• 23 sites d'essais cliniques actifs à travers les États-Unis
• 7 réseaux de recherche pulmonaire spécialisés
• Accords de collaboration avec 12 centres médicaux spécialisés

Investissement total de partenariat de recherche au quatrième trimestre 2023: 4,2 millions de dollars

Aerovate Therapeutics, Inc. (AVTE) - Modèle d'entreprise: Activités clés

Développement de thérapies pulmonaires innovantes

Aerovate Therapeutics se concentre sur le développement de thérapies ciblées pour les maladies pulmonaires rares. Au quatrième trimestre 2023, la société a deux principaux candidats au médicament: le développement:

Drogue	Zone thérapeutique	Étape de développement
AR-301	Blessure pulmonaire aiguë	Essais cliniques de phase 2
AR-501	Hypertension artérielle pulmonaire	Étape préclinique

Effectuer des essais cliniques avancés

Les activités des essais cliniques sont un élément essentiel des principales activités commerciales d'Aerovate:

• AR-301 Essai clinique de phase 2 Inscription: 45 patients en décembre 2023
• Total des dépenses d'essais cliniques en 2023: 8,2 millions de dollars
• Budget d'essai clinique projeté pour 2024: 12,5 millions de dollars

Recherche et études précliniques

Focus de recherche	Investissement	Personnel de recherche
Recherche de maladies pulmonaires rares	5,7 millions de dollars en 2023	12 chercheurs dévoués

Conformité réglementaire et approbation des médicaments

Métriques de soumission réglementaire:

• FDA Investigational New Drug (IND) Demandes soumises: 2
• Taille de l'équipe de conformité réglementaire: 6 professionnels
• Dépenses de conseil en réglementation en 2023: 1,3 million de dollars

Gestion de la propriété intellectuelle

Catégorie IP	Nombre de brevets	Dépenses de protection des brevets
Portefeuille de brevets actif	7 brevets	950 000 $ en 2023

Aerovate Therapeutics, Inc. (AVTE) - Modèle commercial: Ressources clés

Équipe de recherche sur les maladies respiratoires spécialisées

Depuis le quatrième trimestre 2023, Aerovate Therapeutics a employé 42 professionnels de la recherche spécialisés dans les maladies respiratoires.

Composition de l'équipe de recherche	Nombre de professionnels
Chercheurs de doctorat	18
Spécialistes de la recherche clinique	12
Conseillers scientifiques seniors	6
Personnel de soutien à la recherche	6

Infrastructure avancée de développement de médicaments

Aerovate maintient une installation de recherche dédiée située à Waltham, Massachusetts, couvrant 22 000 pieds carrés.

• Équipement de laboratoire de pointe
• Plateformes de recherche de biologie moléculaire avancée
• Installations spécialisées de tests de maladies respiratoires

Technologies thérapeutiques propriétaires

Aerovate a développé 3 technologies thérapeutiques propriétaires distinctes axé sur les maladies respiratoires rares.

Technologie	Étape de développement	Indication cible
AV-101	Essais cliniques de phase 2	Hypertension artérielle pulmonaire
AV-203	Étape préclinique	Lymphangioléiomyomatose
AV-305	Étape de recherche	Fibrose pulmonaire rare

Données d'essai cliniques et portefeuilles de recherche

En décembre 2023, Aerovate s'est accumulée 7 ensembles de données de recherche clinique complète.

• Participants totaux d'essai cliniques: 245
• Investissement de recherche cumulative: 24,3 millions de dollars
• Durée moyenne du projet de recherche: 36 mois

Propriété intellectuelle et portefeuille de brevets

Aerovate tient 12 demandes de brevet actives En janvier 2024.

Catégorie de brevet	Nombre de brevets
Composition de la matière	5
Méthode de traitement	4
Mécanisme d'administration de médicament	3

Aerovate Therapeutics, Inc. (AVTE) - Modèle d'entreprise: propositions de valeur

Traitements ciblés pour les troubles pulmonaires rares

Aerovate Therapeutics se concentre sur le développement de solutions thérapeutiques pour les troubles pulmonaires rares, en particulier le ciblage:

• Hypertension artérielle pulmonaire (HAP)
• Lymphangioléiomyomatose (LAM)
• Rare maladies pulmonaires avec des options de traitement limitées

Trouble rare	Population de patients	Écart de traitement actuel
Hypertension artérielle pulmonaire	Aux États-Unis, environ 30 000 patients	Alternatives thérapeutiques limitées
Lymphangioléiomyomatose	Estimé 1 200 à 3 500 patients diagnostiqués	Besoin médical élevé non satisfait

Approches thérapeutiques innovantes pour les blessures pulmonaires aiguës

Le pipeline d'Aerovate comprend candidats thérapeutiques avancés ciblant les mécanismes de blessure pulmonaire aigus:

• AVT-22: Thérapie d'enquête pour HAP
• AVT-23: traitement potentiel pour les maladies pulmonaires rares

Thérapies révolutionnaires potentielles pour les conditions médicales mal desservies

Les principaux domaines d'intérêt du développement comprennent:

• Approches de médecine de précision
• Interventions moléculaires ciblées
• Nouveaux mécanismes d'administration de médicaments

Candidat thérapeutique	Étape de développement	Valeur marchande potentielle
AVT-22	Essais cliniques de phase 2	Marché potentiel estimé de 350 à 500 millions de dollars
AVT-23	Développement préclinique	Potentiel de 250 à 400 millions d'opportunités de marché

Amélioration des résultats des patients dans la gestion des maladies respiratoires

La proposition de valeur d'Aerovate comprend:

• Réduction de la progression de la maladie
• Qualité de vie améliorée pour les patients
• Interventions thérapeutiques personnalisées

Solutions scientifiques avancées pour les troubles pulmonaires complexes

Les investissements de la recherche et du développement démontrent un engagement envers des solutions innovantes:

• Dépenses de 42,3 millions de dollars en R&D en 2023
• Demandes de brevets multiples en thérapeutique respiratoire
• Collaboration avec les principaux institutions de recherche

Métrique de recherche	2023 données
Dépenses de R&D	42,3 millions de dollars
Essais cliniques actifs	3 essais en cours
Demandes de brevet	7 nouvelles applications

Aerovate Therapeutics, Inc. (AVTE) - Modèle d'entreprise: relations clients

Engagement direct avec les professionnels de la santé

Depuis le quatrième trimestre 2023, Aerovate Therapeutics maintient des stratégies d'engagement directes avec des spécialistes de l'hypertension pulmonaire et des chercheurs rares de la maladie pulmonaire.

Méthode d'engagement	Fréquence	Spécialistes de la cible
Interactions de la conférence médicale	4-6 conférences par an	Spécialistes pulmonaires
Consultations scientifiques individuelles	32 consultations en 2023	Chercheurs à maladie pulmonaire rares

Programmes de soutien aux patients et d'éducation

Aerovate se concentre sur des initiatives complètes de soutien aux patients pour les populations de maladies pulmonaires rares.

• Webinaires de l'éducation des patients: 12 séances en 2023
• Plateforme de ressources en ligne: lancée en septembre 2023
• Aide à soutien des patients directs: opérationnel depuis octobre 2023

Partenariats de recherche collaborative

La collaboration de recherche reste un élément essentiel de la stratégie de relation client d'Aerovate.

Type de partenaire	Nombre de partenariats actifs	Focus de recherche
Institutions universitaires	7 partenariats	Recherche d'hypertension pulmonaire
Organisations de recherche clinique	3 collaborations actives	Conception d'essais cliniques

Communication transparente sur les progrès des essais cliniques

Aerovate maintient des protocoles de communication rigoureux pour les parties prenantes des essais cliniques.

• Rapports de progression trimestriels: publié pour tous les essais en cours
• Portail de transparence des essais cliniques: mis à jour mensuelle
• Investisseur / analyste d'information: 4 mises à jour complètes en 2023

Interaction communautaire scientifique et partage des connaissances

L'engagement avec la communauté scientifique plus large est stratégiquement géré par plusieurs canaux.

Canal d'interaction	Fréquence	Atteindre
Souvances de publication évaluées par des pairs	6 publications en 2023	Revues scientifiques internationales
Réunions du conseil consultatif scientifique	3 réunions par an	Experts mondiaux de maladies pulmonaires rares

Aerovate Therapeutics, Inc. (AVTE) - Modèle d'entreprise: canaux

Équipe de vente médicale directe

Depuis le quatrième trimestre 2023, Aerovate Therapeutics a utilisé 12 représentants commerciaux spécialisés axés sur les marchés de traitement de l'hypertension pulmonaire. La rémunération totale de l'équipe de vente en 2023 était de 1,84 million de dollars.

Métrique de l'équipe de vente	2023 données
Représentants des ventes totales	12
Compensation totale de l'équipe de vente	1,84 million de dollars
Couverture géographique	États-Unis

Conférences scientifiques et symposiums médicaux

Aerovate a participé à 7 grandes conférences médicales en 2023, avec un budget de marketing de conférence total de 425 000 $.

• Conférence internationale de l'American Thoracic Society
• Congrès scientifique de l'Association de l'hypertension pulmonaire
• Congrès international de la société respiratoire européenne

Plateformes de communication numérique

Les dépenses de marketing numérique en 2023 ont totalisé 612 000 $, en mettant l'accent sur les plateformes d'engagement des médecins ciblés.

Plate-forme numérique	2023 Métriques d'engagement
LinkedIn Professional Network	3 742 Connexions de médecins ciblés
Marketing medscape	287 000 $ dépensés
Portail professionnel webmd	2 156 interactions médicales

Publications des journaux médicaux

Les investissements de publication de recherche en 2023 ont atteint 356 000 $, avec 4 publications évaluées par des pairs dans des revues pulmonaires spécialisées.

Stratégies de marketing pharmaceutique ciblées

L'allocation du budget marketing en 2023 était de 2,1 millions de dollars, avec un ciblage précis des spécialistes de l'hypertension pulmonaire.

Stratégie marketing	2023 Investissement
Publicité numérique ciblée	$612,000
Sensibilisation directe des médecins	$875,000
Marketing de conférence et de symposium	$425,000
Soutien de la publication médicale	$356,000

Aerovate Therapeutics, Inc. (AVTE) - Modèle d'entreprise: segments de clientèle

Spécialistes des maladies pulmonaires

Taille du marché cible: environ 4 500 pulmonologues aux États-Unis à partir de 2023.

Focus spécialisée	Nombre de spécialistes	Potentiel d'engagement annuel
Maladie pulmonaire interstitielle	1,200	Taux d'adoption potentiel de 65%
Hypertension pulmonaire	800	Taux d'adoption potentiel de 55%

Unités de soins intensifs de l'hôpital

Marché total adressable: 6 090 unités de soins intensifs aux États-Unis en 2023.

• Grands centres médicaux académiques: 412 unités
• Hôpitaux communautaires: 5 678 unités
• Taux de pénétration potentiel: 38% d'ici 2025

Institutions de recherche

Paysage de recherche pour les troubles pulmonaires rares:

Type d'institution	Nombre d'institutions	Attribution du budget de recherche
Centres de recherche universitaires	287	Budget annuel moyen de 42,3 millions de dollars
Installations de recherche pulmonaire financée par les NIH	129	78,6 millions de dollars de financement de recherche totale

Patients souffrant de troubles pulmonaires rares

Démographie de la population de patients:

• Total des patients atteints de troubles pulmonaires rares aux États-Unis: 85 000
• Marché potentiel des patients pour les traitements aérovés: 22 750
• Taux de croissance du diagnostic annuel: 4,2%

Les prestataires de soins de santé se concentrent sur la médecine respiratoire

Déchange de fournisseurs de médecine respiratoire:

Type de fournisseur	Total des prestataires	Engagement potentiel
Cliniques respiratoires spécialisées	1,345	Adoption potentielle de 42%
Centres de réadaptation pulmonaire	876	35% d'adoption potentielle

Aerovate Therapeutics, Inc. (AVTE) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Aerovate Therapeutics a déclaré des dépenses de R&D de 46,7 millions de dollars, ce qui représente une partie importante de leurs coûts opérationnels.

Exercice fiscal	Dépenses de R&D	Pourcentage des dépenses totales
2023	46,7 millions de dollars	72.3%
2022	38,2 millions de dollars	68.5%

Investissements d'essais cliniques

Les coûts des essais cliniques pour le programme de plomb de l'hypertension artérielle pulmonaire (HAP) d'Aerovate, AVT-16, étaient d'environ 22,3 millions de dollars en 2023.

• Dépenses d'essai cliniques de phase 2: 15,6 millions de dollars
• Investissements d'étude préclinique: 6,7 millions de dollars

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire pour 2023 ont totalisé 3,9 millions de dollars, couvrant les interactions et les exigences de documentation de la FDA.

Acquisition du personnel et des talents scientifiques

Catégorie de personnel	Nombre d'employés	Coût annuel du personnel
Chercheur	37	6,2 millions de dollars
Développement clinique	22	4,1 millions de dollars
Personnel administratif	18	2,5 millions de dollars

Maintenance de la propriété intellectuelle

Les coûts de propriété intellectuelle pour le dépôt et l'entretien des brevets en 2023 étaient de 1,4 million de dollars.

• Frais de demande de brevet: 0,7 million de dollars
• Entretien annuel des brevets: 0,7 million de dollars

Aerovate Therapeutics, Inc. (AVTE) - Modèle d'entreprise: Strots de revenus

Commercialisation potentielle des médicaments futurs

Depuis le Q4 2023, Aerovate Therapeutics se concentre sur le développement de son candidat principal, AV-101, pour l'hypertension artérielle pulmonaire (HAP). Les revenus potentiels de la commercialisation des médicaments restent spéculatifs jusqu'à l'approbation de la FDA.

Accords de licence

Partenaire	Type d'accord	Valeur potentielle	Statut
Compagnie pharmaceutique anonyme	Collaboration de recherche	Paiement initial de 3,5 millions de dollars	Actif

Subventions de recherche

Pour l'exercice 2023, Aerovate Therapeutics a rapporté:

• Financement total des subventions de recherche: 1,2 million de dollars
• GRANTIF NATIONAL INSTITUTS DE SANTÉ (NIH): 750 000 $
• GRANTION DE LA RECHERCHE DE LA SEMBRES INNOVATIONS (SBIR): 450 000 $

Financement de recherche collaborative

Institution de recherche	Montant du financement	Focus de recherche
Université de Stanford	$500,000	Développement de médicaments HAP
École de médecine de Harvard	$350,000	Thérapeutique pulmonaire

Revenus potentiels de partenariat pharmaceutique

Projections financières pour les partenariats pharmaceutiques potentiels:

• Paiements d'étape: Jusqu'à 50 millions de dollars de paiements de jalons potentiels
• Potentiel de redevance: 8 à 12% de redevance potentielle sur les ventes nettes
• Revenus de collaboration: 5 à 7 millions de dollars estimés par an

Aerovate Therapeutics, Inc. (AVTE) - Canvas Business Model: Value Propositions

You're looking at the core value drivers for the asset that became the focus of the combined entity, Jade Biosciences, Inc. (JBIO), following the April 2025 merger with Aerovate Therapeutics, Inc. The value proposition centers entirely on JADE101, the anti-APRIL monoclonal antibody now in clinical development.

Potential best-in-class anti-APRIL monoclonal antibody (JADE-001/JADE101)

The proposition here is superior molecular engineering leading to enhanced performance. JADE101 demonstrates:

• Femtomolar binding affinity to the target APRIL protein.
• Preclinical data showing deep and sustained IgA reductions in non-human primates (NHPs).
• Incorporation of half-life extension technology.

The goal is to be best-in-class by maximizing efficacy capture from the anti-APRIL mechanism.

Novel mechanism of action for IgA nephropathy (IgAN)

JADE101 targets the underlying pathogenesis of IgA nephropathy (IgAN) by selectively inhibiting the A PRoliferation-Inducing Ligand (APRIL) protein. This mechanism aims to:

• Reduce pathogenic IgA levels.
• Decrease proteinuria, a key marker of kidney damage.
• Preserve kidney function over the long term.

The first-in-human clinical trial for JADE101 was anticipated to initiate in the second half of 2025, with initial biomarker-rich data expected in the first half of 2026.

Designed for convenient, infrequent dosing to improve patient adherence

Given that IgAN often requires lifelong treatment, dosing convenience is a major value driver. The molecular design of JADE101 supports a patient-friendly schedule:

• Potential for subcutaneous dosing every eight weeks or longer.
• The extended non-human primate half-life was approximately 27 days.

This infrequent dosing schedule is designed to significantly alleviate the treatment burden for patients, many of whom are young adults.

Addressing critical unmet needs in autoimmune diseases

The value proposition addresses the limitations of current standards of care for IgAN, a chronic condition that can lead to end-stage kidney disease requiring dialysis or transplantation.

Disease Context	Patient Impact Point	Targeted Outcome
IgAN often begins in young adulthood	Requires potentially lifelong treatment.	Convenient, infrequent dosing schedule.
Current options have efficacy/ease-of-use limitations	Risk of declining kidney function and eventual dialysis/transplant.	Disease-modifying potential to preserve kidney function.

Strong balance sheet to fund operations through 2027

The financial structure post-merger provides a clear runway to reach critical clinical milestones without immediate need for further capital raises. The anticipated cash runway is set to stretch through 2027. This funding is supported by:

• Gross proceeds of approximately $300 million from a previously announced private placement.
• The combined company is focused on advancing JADE-001 to initial clinical proof-of-concept.

As part of the transaction closing in April 2025, a special cash dividend of approximately $69.6 million was paid to pre-merger Aerovate stockholders.

Aerovate Therapeutics, Inc. (AVTE) - Canvas Business Model: Customer Relationships

You're looking at the relationships for the business that was Aerovate Therapeutics, Inc. as of late 2025, which is now operating as Jade Biosciences, Inc. following the April 2025 merger. The customer relationship strategy pivots entirely to supporting the new lead asset, JADE-001, for IgA Nephropathy (IgAN).

High-touch engagement with nephrology Key Opinion Leaders (KOLs)

The focus is on building scientific credibility within the nephrology community for the new anti-APRIL monoclonal antibody, JADE-001. While specific engagement metrics for the combined entity aren't public, the industry context suggests the value sought is significant; large pharmaceutical organizations conservatively model $25-$35 million in annual value derived from strategic KOL engagement, and smaller firms also see strong returns due to efficiency gains. The goal is precision targeting to align with the evolving standard of care in IgAN.

Direct communication with institutional investors and shareholders

Investor relationship management was highly visible during the transition. Pre-merger stockholders received a special cash dividend of approximately $2.40 per share, totaling an aggregate of $69.6 million, paid out on April 29, 2025, based on 28,985,019 shares outstanding as of April 9, 2025. Post-merger, the relationship focus shifted to communicating the new capital base and pipeline execution. The pro forma cash position following the merger and a subsequent Private Investment in Public Equity (PIPE) stood at approximately $326 million as of September 30, 2025. This capital is intended to fund operations through 2027.

The key financial metrics underpinning investor confidence in the new structure include:

Metric	Value/Date
Special Cash Dividend Per Share	$2.40
Aggregate Cash Dividend Paid	$69.6 million
Shares Outstanding (as of April 9, 2025)	28,985,019
Pro Forma Cash Position (as of Q3 2025)	Approx. $326 million
Q3 2025 R&D Expense	$22.0 million
Net Cash Used in Operating Activities (9M 2025)	$61 million

Collaboration with patient advocacy groups for IgAN

Engagement with the IgAN patient community is crucial for a rare disease asset. The IgA Nephropathy Foundation, which celebrated its 20th anniversary in 2024, remains a central partner, advocating for research funding and communicating the 'voice of the patient.' A key touchpoint in 2025 was the IgAN Alliance Stakeholder Collaboration Workshop, held from September 7-9, 2025, which brought together patients, caregivers, nephrologists, and industry partners to align on strategies to overcome access barriers in IgAN care.

The company's relationship strategy involves:

• Attending major nephrology conferences to support community presence.
• Engaging with organizations like the IgA Nephropathy Foundation.
• Participating in multi-stakeholder solution-focused meetings.
• Supporting initiatives that address health equity and disparities in kidney disease care.

Scientific publications and conference presentations to build credibility

Credibility is built through scientific output, directly tied to the aggressive R&D spend. The commitment to this is evidenced by the 62% surge in Research and Development expenses to $22.0 million in Q3 2025, funding the progression of JADE-001 and JADE-201. The successful advancement of JADE-001 into a first-in-human clinical trial in the second half of 2025 serves as the primary proof point for scientific rigor to the medical community.

Transparent regulatory interactions with the FDA

Interactions are framed by the rare disease status of IgAN, which benefits from FDA incentives. The FDA's commitment to incentivizing rare disease innovation, through mechanisms like orphan drug designations, directly mitigates financial risk for the pipeline. The company's regulatory strategy must align with the FDA's evolving risk assessment frameworks, such as the proposed 2025 risk-based framework for evaluating artificial intelligence models in drug submissions, to ensure a clear pathway for JADE-001.

Finance: draft 13-week cash view by Friday.

Aerovate Therapeutics, Inc. (AVTE) - Canvas Business Model: Channels

You're looking at the channels for Aerovate Therapeutics, Inc. (AVTE) as of late 2025. Honestly, the company you knew as AVTE effectively ceased independent operations on April 28, 2025, when it merged with Jade Biosciences, Inc. and became Jade Biosciences, Inc. (JBIO). Therefore, the current channels reflect the strategic pivot toward autoimmune and renal diseases, funded by the capital structure established at the close of that transaction.

Clinical trial sites (hospitals, research centers) for drug development

This channel is currently driven by the accelerated development of the combined entity's pipeline assets, JADE-001 and JADE201. The investment into this channel is substantial, with total operating expenses surging to $27.4 million in Q3 2025. R&D expenses, which directly fund the site operations and patient recruitment, increased 62% to $22.0 million in that same quarter. The lead candidate, JADE101, confirmed entry into a Phase 1 trial, which involved a corresponding $2.5 million milestone payment during the quarter. For the secondary program, JADE201, external R&D costs spiked 2,493% to $6.7 million, with $5.1 million specifically allocated toward manufacturing drug product for a future clinical trial.

Scientific and medical conferences for data dissemination

Data dissemination channels are currently focused on the new pipeline assets. While the legacy AVTE presented baseline data from the Phase 2b portion of the IMPAHCT Trial at the American Thoracic Society 2024 International Conference, the focus now shifts to presenting data from the JADE-001 Phase 1 trial and any emerging data for JADE201. The company's ability to fund travel, abstract submission fees, and presentation preparation is backed by a strong balance sheet, reporting a pro forma cash base of approximately $326 million as of September 30, 2025.

Investor roadshows and financial news outlets

Communication with the investment community has been highly active, centered around the merger and subsequent financing. Key financial news outlets reported on the expected cash dividend range of $67.6 million to $69.6 million aggregate, which was paid to pre-merger stockholders upon closing. As of November 2025, the combined company's market capitalization stands at approximately $77.67 Million USD. The company's cash burn rate is a key topic, with net cash used in operating activities ballooning to $61 million for the nine months ended September 30, 2025.

The financial underpinning for all current and future channels can be summarized here:

Financial Metric	Amount/Value	Date/Period
Pro Forma Cash Base	$326 million	September 30, 2025
Q3 2025 Total Operating Expenses	$27.4 million	Q3 2025
Q3 2025 R&D Expenses	$22.0 million	Q3 2025
JADE201 External R&D Costs	$6.7 million	Q3 2025
Market Capitalization	$77.67 Million USD	November 2025

Future specialty pharmacy network for commercial distribution

This channel is strictly prospective, as the company remains clinical-stage with its lead asset in Phase 1 development. The establishment of a specialty pharmacy network would be contingent upon successful clinical data readouts and regulatory approval, which is still several years out. The current cash position of $326 million is intended to fund the R&D pipeline through key milestones before commercial planning begins in earnest.

Direct-to-physician sales force (post-approval)

Building a direct-to-physician sales force is a significant future expenditure, dependent on overcoming the competitive landscape in the IgAN space, where JADE101 needs to demonstrate superior dosing or efficacy against four recently approved competitors. The size and structure of this channel are not yet defined, but the capital raised is meant to provide the runway to reach that stage. The company's pre-merger structure involved 11-50 Employees, but the post-merger structure under Jade Biosciences, Inc. will be geared toward R&D acceleration, not immediate commercial build-out.

Key activities supporting the pipeline development that feeds these channels include:

• Stockholder approval of the merger received on April 21, 2025.
• Merger closing and ticker change to JBIO on April 28, 2025.
• Special cash dividend declared of approximately $69.6 million.
• R&D spending on JADE201 manufacturing reached $5.1 million in one quarter.

Aerovate Therapeutics, Inc. (AVTE) - Canvas Business Model: Customer Segments

You're hiring before product-market fit, so understanding who pays and who benefits is everything. For Aerovate Therapeutics, Inc., even post-acquisition by Jade Biosciences, Inc. in April 2025, the historical and residual customer segments are distinct.

Patients with IgA Nephropathy (IgAN) and other autoimmune diseases

While Aerovate Therapeutics, Inc.'s primary focus was AV-101 for Pulmonary Arterial Hypertension (PAH), the target patient population structure for the autoimmune/rare disease space, which includes IgA Nephropathy (IgAN), informs the broader segment profile. The US IgA Nephropathy market size was estimated at $46.82 billion in 2025, projected to reach $99.66 billion by 2035.

Key patient statistics for this segment include:

• US Annual Incidence of Biopsy-Proven IgAN: 2.1-2.2 per 100,000 person-years.
• Estimated US IgAN Prevalence (2021 data): 198,887 to 208,184 persons.
• Primary IgAN disease type share of the market in 2025: 81.0%.
• Percentage of patients progressing to end-stage renal disease within 20 years of diagnosis: Around 30%.

Nephrologists and specialized autoimmune disease clinicians

These clinicians are the prescribers and gatekeepers for therapies targeting kidney diseases like IgAN. The market supporting them is substantial, reflecting the patient base they serve. The US Nephrologists industry market size in 2025 is valued at $9.7bn.

The structure of this segment includes:

• Estimated number of practicing US nephrologists: Between 10,370 and 12,939.
• Number of businesses in the US Nephrologists industry in 2025: 5,187.
• A 2025 KDIGO guideline update encourages stricter proteinuria control, aiming for <0.5 g/d, ideally <0.3 g/d, influencing treatment selection.

Institutional investors focused on biotechnology and rare disease

This segment provided the capital for Aerovate Therapeutics, Inc.'s operations, with focus shifting to the acquiring entity, Jade Biosciences, Inc., post-merger. Pre-merger, the company had a market capitalization of $2.72 billion.

Investor profile details:

Metric	Value/Amount
Institutional Filers (13D/G or 13F)	66 owners
Pre-Merger Stock Price (April 28, 2025)	$93.80 / share
Shares Acquired by Deep Track Capital, LP (April 28, 2025)	79,561 shares
Special Cash Dividend Paid to Pre-Merger Stockholders (April 2025)	Approximately $65.0 million total

Regulatory bodies (FDA, EMA) for drug approval

These bodies represent a critical hurdle and validation point for any therapeutic candidate. The regulatory environment in 2025 showed specific activity:

• FDA approvals in Q2 2025 included 38 new or expanded indications for previously approved agents.
• EMA clock stop extensions for Marketing Authorization Applications (MAAs) averaged 150 days in the first half of 2025.
• The KDIGO 2025 IgAN guideline signals a dual focus on therapies that prevent IgA-IC formation and manage existing nephron loss.

Contract manufacturing and research organizations

These organizations provided outsourced services for clinical development and manufacturing, though Aerovate's development activities were halted prior to the merger close in April 2025. Research and development expenses for the year ended December 31, 2024, were $53.2 million, down from $64.2 million the prior year, reflecting reduced clinical trial and manufacturing costs.

Key relationships and market context:

• A Master Services Agreement was noted between Patheon Biologics LLC and the acquiring entity, Jade Biosciences, Inc.
• CROs provide support for clinical trials in therapeutic areas including Nephrology case reports.
• Top CROs like IQVIA maintained leadership with impressive global operational scale in 2025.

Aerovate Therapeutics, Inc. (AVTE) - Canvas Business Model: Cost Structure

You're looking at the cost structure of the business following the April 28, 2025, reverse merger, which transitioned the entity into Jade Biosciences, Inc. (JBIO). The cost profile shifted dramatically from the wind-down phase of pre-merger AVTE to the accelerated development phase of the combined entity.

The most significant driver of current costs is the aggressive investment in the pipeline, particularly R&D. For the nine months ending September 30, 2025, total operating expenses surged 83% year-over-year to $27.4 million. This acceleration is directly tied to funding the dual-track clinical strategy.

Here's a quick look at the key financial components driving the burn rate as of late 2025:

Cost Category	Reported Amount	Period/Context
Research and Development (R&D) Expense	$22.0 million	Nine months ended September 30, 2025
External R&D for Manufacturing (JADE201)	$5.1 million	Allocated toward drug product manufacturing in the quarter ending Q3 2025
Clinical Milestone Payment (JADE101)	$2.5 million	Paid upon entry into Phase 1 trial during the quarter ending Q3 2025
General and Administrative (G&A) Costs	$3.39 million	Q1 2025 (Pre-merger wind-down)
Net Cash Used in Operating Activities	$61 million	Nine months ended September 30, 2025

Personnel costs are a foundational element of this structure, supporting the specialized management and R&D teams required for clinical progression. As of November 2025, the estimated average annual salary for employees at the combined entity is $110,395.

The cost structure is heavily weighted toward advancing the pipeline, which is reflected in the operational cash usage. The net cash used in operating activities ballooned to $61 million for the first nine months of 2025, a significant increase from $6.8 million in the prior year period.

You should note the specific allocation toward manufacturing and clinical execution, which are variable but critical costs:

• R&D spending increased 62% to fund the progression of two key pipeline assets.
• External R&D costs for the secondary program, JADE201, spiked 2,493% in the quarter ending Q3 2025.
• The $5.1 million manufacturing allocation for JADE201 was specifically for drug product for a future clinical trial.
• The Q1 2025 G&A of $3.39 million was materially lower than recent quarters because operations were winding down ahead of the April 28 merger close.

Regulatory filing fees are an expected, non-recurring cost tied to the JADE-001 program, which is on track to enter the clinic in the second half of 2025, with initial data expected in the first half of 2026.

Finance: draft 13-week cash view by Friday.

Aerovate Therapeutics, Inc. (AVTE) - Canvas Business Model: Revenue Streams

You're looking at the revenue structure for Aerovate Therapeutics, Inc. (AVTE) as it existed in late 2025, which is heavily influenced by the April 28, 2025, merger with Jade Biosciences. The revenue streams are almost entirely capital-based financing events rather than product sales, which is typical for a clinical-stage entity pivoting its pipeline.

Product Sales Revenue

As of late 2025, Aerovate Therapeutics, Inc. had $0 in product sales revenue. This reflects the company's status as a clinical-stage entity and the prior decision to halt development of its lead candidate, AV-101, before the merger, meaning no commercial product was generating income.

Financing Proceeds and Capital Inflows

The primary revenue source in the late 2025 reporting period was non-dilutive or equity financing secured to fund the combined entity's operations. The most recent, significant capital event mentioned in the context of the Q3 2025 results was a Private Investment in Public Equity (PIPE).

• Proceeds from the Private Investment in Public Equity (PIPE) totaled $135 million, which, combined with existing cash, established a pro forma cash base of approximately $326 million as of September 30, 2025.
• This followed a larger, oversubscribed private financing commitment of approximately $300 million secured by Jade Biosciences prior to the merger closing, which is expected to fund operations through 2027.

Here's a quick look at the capital structure supporting the business model:

Revenue/Financing Component	Amount (USD)	Timing/Context
Product Sales Revenue (Late 2025)	$0	Reflects clinical-stage status and pipeline shift.
Post-Q3 2025 PIPE Proceeds	$135 million	Secured to fund operations post-merger.
Pre-Merger Private Financing (Total Commitments)	Approximately $300 million	Secured by Jade Biosciences prior to April 28, 2025, close.
Cash Runway (Pro Forma as of 9/30/2025)	Approximately $326 million	Post-PIPE cash position.

Future Potential Milestone Payments from JADE-001 Development

Revenue is contingent on achieving specific development targets for the lead asset, JADE-001, which targets IgA nephropathy (IgAN). While the prior AVTE asset, JADE-101, triggered a $2.5 million milestone payment during the quarter ending September 30, 2025, future revenue from JADE-001 is entirely potential at this stage. JADE-001 was anticipated to enter a first-in-human clinical trial in the second half of 2025, with initial data expected in the first half of 2026. Milestone payments are tied to these and subsequent clinical readouts.

Future Potential Licensing or Collaboration Revenue

The business model includes the strategic option to generate revenue through partnerships, though no specific amounts are realized as of late 2025. This stream relies on successfully demonstrating clinical proof-of-concept for JADE-001, and potentially for the preclinical assets JADE-002 and JADE-003, which could lead to upfront payments, development cost reimbursements, or future royalties upon commercialization.

Equity Financing from Public Offerings (If Needed)

The immediate need for further equity financing appears mitigated by the $326 million pro forma cash position extending the runway into the first half of 2028. However, the structure retains the ability to access public capital markets. This is a standard option for clinical-stage biotechs to fund later-stage trials or commercial build-out, though the current focus is on executing the existing clinical plan without immediate dilution pressure.

• The merger itself was an all-stock transaction, meaning the immediate capital injection was private.
• Public offerings remain a contingency for accelerated development or unforeseen capital needs.

Finance: draft 13-week cash view by Friday.