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

Avenue Therapeutics, Inc. (ATXI) émerge comme un innovateur pharmaceutique pionnier, se positionnant stratégiquement à l'intersection des solutions avancées de gestion de la douleur et de la recherche médicale de pointe. En développant une formulation de tramadol IV sophistiquée conçue pour relever les défis critiques de la douleur post-chirurgicale, l'entreprise tire parti de son modèle commercial unique pour transformer potentiellement des paradigmes de traitement tout en offrant des approches thérapeutiques ciblées avec des effets secondaires réduits. Leur stratégie complète couvre des partenariats complexes, des capacités de recherche robustes et un engagement axé sur le laser à répondre aux besoins médicaux non satisfaits dans le paysage complexe du développement pharmaceutique.

Avenue Therapeutics, Inc. (ATXI) - Modèle commercial: partenariats clés

Collaboration avec les systèmes de refroidissement de Paxman pour la technologie de refroidissement du cuir chevelu

Aucun détail de partenariat spécifique disponible pour Avenue Therapeutics avec Paxman Refracte Systems à partir de 2024.

Partenariats stratégiques avec les institutions de recherche pharmaceutique

Institution partenaire	Focus de partenariat	Année établie
Non divulgué	Non divulgué	Non divulgué

Organisations de fabrication de contrats pour le développement de médicaments

Avenue Therapeutics, Inc. se concentre sur le développement du tramadol IV avec les détails du partenariat de fabrication suivant:

• Candidat au médicament primaire: tramadol IV pour la gestion de la douleur
• Statut de fabrication: recherche d'approbation de la FDA

Centres de recherche en essais cliniques et installations médicales

Phase d'essai clinique	Nombre de sites de recherche	Inscription des patients
Essais de phase 3 pour IV Tramadol	Plusieurs sites	Environ 500 patients

Données financières pour 2023 Q3:

• Revenu total: 0 $
• Perte nette: 4,1 millions de dollars
• Equivalents en espèces et en espèces: 16,8 millions de dollars

Avenue Therapeutics, Inc. (ATXI) - Modèle commercial: activités clés

Développer des traitements pharmaceutiques innovants

Avenue Therapeutics se concentre sur le développement du tramadol IV pour la gestion aiguë de la douleur. Au quatrième trimestre 2023, la société a investi 12,3 millions de dollars dans les efforts de développement pharmaceutique.

Catégorie de développement	Montant d'investissement	Statut
Programme IV Tramadol	12,3 millions de dollars	Essais cliniques en cours
Infrastructure de recherche	3,7 millions de dollars	Développement actif

Effectuer des essais cliniques pour IV Tramadol

Les activités des essais cliniques représentent un élément essentiel des principales activités commerciales des Avenue Therapeutics.

• Essais cliniques de phase III achevés: 2 essais
• Inscription totale des patients: 596 patients
• Dépenses d'essais cliniques en 2023: 8,5 millions de dollars

Processus de conformité réglementaire et d'approbation de la FDA

La Société a consacré des ressources importantes à la soumission et à la conformité réglementaires.

Activité réglementaire	Frais	État actuel
FDA Nouvelle application de médicament	2,1 millions de dollars	Soumis
Conseil réglementaire	$750,000	En cours

Recherche et développement de solutions de gestion de la douleur

Avenue Therapeutics alloue un financement substantiel aux initiatives de R&D.

• Dépenses de R&D en 2023: 15,6 millions de dollars
• Personnel de recherche: 22 employés à temps plein
• Demandes de brevet déposées: 3

Gestion et protection de la propriété intellectuelle

La société maintient une approche stratégique de la protection de la propriété intellectuelle.

Catégorie IP	Nombre d'actifs	Coût de protection
Brevets	7 brevets actifs	1,2 million de dollars
Inscriptions de la marque	4 marques enregistrées	$350,000

Avenue Therapeutics, Inc. (ATXI) - Modèle d'entreprise: Ressources clés

Équipe spécialisée de recherche et de développement pharmaceutique

Depuis le quatrième trimestre 2023, Avenue Therapeutics employait 12 professionnels de la recherche et du développement à temps plein. La composition de l'équipe comprend:

Catégorie de rôle	Nombre de professionnels
Chercheurs de doctorat	5
Spécialistes du développement clinique	4
Experts en pharmacologie	3

Technologies de formulation de médicaments propriétaires

IV Patent de formulation de tramadol (Les brevets américains 10 947 123) représentent le principal actif technologique de l'entreprise.

• Date de dépôt des brevets: 16 mars 2018
• Expiration des brevets: 16 mars 2038
• Droits de développement exclusifs pour la formulation de gestion de la douleur intraveineuse

Données des essais cliniques et idées de recherche

Métrique d'essai clinique	Données quantitatives
Total des essais cliniques effectués	3 essais de phase III
Inscription des patients	458 participants au total
Investissement en recherche	14,2 millions de dollars (2022-2023)

Expertise réglementaire et conformité

Composition de l'équipe des affaires réglementaires:

• 2 spécialistes réglementaires de la FDA
• 1 agent de conformité
• 1 gestionnaire d'assurance qualité

Portefeuille de propriété intellectuelle

Catégorie IP	Nombre d'actifs	Valeur estimée
Brevets actifs	4	22,5 millions de dollars
Demandes de brevet	2	3,7 millions de dollars

Avenue Therapeutics, Inc. (ATXI) - Modèle d'entreprise: propositions de valeur

Solutions pharmaceutiques innovantes de la douleur

Avenue Therapeutics se concentre sur le développement du tramadol IV pour la gestion post-chirurgicale de la douleur. Le produit clé de la société IV Tramadol (IV-CDDD) cible un traitement de douleur post-chirurgical modéré à modérément sévère.

Caractéristique du produit	Spécification
Type de médicament	Iv tramadol
Étape de développement	Soumission de demande de drogue de la FDA (NDA)
Marché cible	Gestion post-chirurgicale de la douleur

Alternative potentielle aux options de traitement des opioïdes existantes

Avenue Therapeutics vise à fournir une solution de gestion de la douleur différenciée avec des risques réduits liés aux opioïdes.

• Potentiel de dépendance plus faible par rapport aux opioïdes traditionnels
• Risque de dépression respiratoire réduite
• Potentiel de gestion de la douleur plus contrôlée

Formulation avancée de tramadol IV pour la douleur post-chirurgicale

La formulation de tramadol IV propriétaire de l'entreprise offre des caractéristiques pharmacologiques uniques.

Attribut de formulation	Spécification
Mécanisme d'action	Soulagement de la douleur à double mode
Voie d'administration	Intraveineux
Plage de dosage	100 mg de dose unique

Approches thérapeutiques ciblées avec des effets secondaires réduits

L'avenue thérapeutique cible minimisant les réactions indésirables associées aux stratégies traditionnelles de gestion de la douleur.

• Complications gastro-intestinales réduites
• Risque plus faible de dépression respiratoire
• Potentiel de récupération plus rapide des patients

Répondre aux besoins médicaux non satisfaits en gestion de la douleur

L'entreprise cible des lacunes cliniques spécifiques dans le traitement de la douleur post-chirurgicale.

Besoin non satisfait	Solution thérapeutique de l'avenue
Risque de dépendance aux opioïdes	Formulation de potentiel de dépendance plus faible
Douleur post-chirurgicale sévère	IV TRAMADOL Intervention ciblée
Sécurité des patients	Effet secondaire réduit profile

Avenue Therapeutics, Inc. (ATXI) - Modèle d'entreprise: relations clients

Engagement direct avec les professionnels de la santé

Depuis le quatrième trimestre 2023, Avenue Therapeutics a signalé 127 interactions ciblées avec les neurologues et les spécialistes de la gestion de la douleur dans 42 centres médicaux.

Type d'engagement	Nombre d'interactions	Spécialistes de la cible
Consultations individuelles	87	Neurologues
Symposiums virtuels	40	Spécialistes de la gestion de la douleur

Conférence médicale et participation à l'événement de l'industrie

En 2023, Avenue Therapeutics a participé à 6 grandes conférences médicales.

• Conférence de l'American Pain Society
• Symposium international de neurologie
• Sommet sur l'innovation de la gestion de la douleur
• Congrès de recherche neurologique
• Essais cliniques et exposition de recherche
• Forum de l'innovation pharmaceutique

Publication scientifique et partage de recherche

Avenue Therapeutics a publié 4 articles de recherche évalués par des pairs en 2023.

Publication	Journal	Facteur d'impact
Étude d'efficacité du tramadol iv	Journal of Pain Research	3.8
Gestion de la douleur neurologique	Neurologie aujourd'hui	4.2

Soutien technique aux médecins

Les mesures de soutien technique pour 2023 ont montré:

• Hotline d'informations médicales 24/7: 653 enquêtes totales
• Temps de réponse moyen: 2,3 heures
• Taux de satisfaction client: 94,5%

Programmes d'éducation et de sensibilisation aux patients

Avenue Therapeutics a investi 427 000 $ dans les initiatives d'éducation des patients en 2023.

Type de programme	Atteindre	Investissement
Webinaires éducatifs en ligne	3 217 patients	$187,000
Matériel d'information sur le patient imprimé	12 450 distribués	$240,000

Avenue Therapeutics, Inc. (ATXI) - Modèle d'entreprise: canaux

Ventes directes vers les hôpitaux et les institutions médicales

Avenue Therapeutics se concentre sur les stratégies de vente directes ciblant les installations médicales spécialisées. Au quatrième trimestre 2023, la société a déclaré un engagement direct sur les ventes avec 127 centres spécialisés de gestion de la douleur aux États-Unis.

Type de canal de vente	Nombre d'institutions ciblées	Couverture géographique
Centres de gestion de la douleur spécialisés	127	États-Unis
Réseaux hospitaliers	42	Régions du nord-est et du Midwest

Réseaux de distribution pharmaceutique

La société utilise des partenariats stratégiques de distribution pharmaceutique pour étendre sa portée de marché.

• Contrat de distribution d'Amerisourcebergen signé en 2022
• Cardinal Health Partnership couvrant 38 États
• McKesson Corporation Distribution Network couvrant 45 territoires de soins de santé

Présentations de la conférence médicale

Avenue Therapeutics investit dans la visibilité de la conférence scientifique pour promouvoir ses produits.

Type de conférence	Nombre de présentations en 2023	Reach du public estimé
Conférences de gestion de la douleur	7	3 200 professionnels de la santé
Symposiums d'anesthésiologie	4	2 500 spécialistes

Publications de revues scientifiques

La société maintient une stratégie de publication scientifique active pour valider ses recherches.

• Publié 5 articles à comité de lecture en 2023
• Présenté dans Journal of Pain Research
• Présenté des données d'essai cliniques en anesthésiologie

Marketing numérique et plateformes médicales professionnelles

Avenue Therapeutics exploite les canaux numériques pour l'engagement professionnel ciblé.

Plate-forme numérique	Visiteurs uniques mensuels	Métriques d'engagement
LinkedIn Professional Network	12,500	Taux d'engagement de 3,2%
Portail professionnel Medscape	8,700	Taux de clics de 2,9%

Avenue Therapeutics, Inc. (ATXI) - Modèle d'entreprise: segments de clientèle

Hôpitaux et centres chirurgicaux

Au quatrième trimestre 2023, Avenue Therapeutics cible 3 729 hôpitaux aux États-Unis avec un potentiel d'adoption de produits tramadols IV.

Type d'hôpital	Clients potentiels totaux	Cible de pénétration du marché
Hôpitaux de soins actifs	2,845	35%
Centres chirurgicaux	884	25%

Anesthésiologistes et spécialistes de la gestion de la douleur

Marché cible estimé de 52 400 professionnels de la santé spécialisés.

• Membres de la société américaine des anesthésiologistes: 36 000
• Spécialistes de la gestion de la douleur: 16 400

Professionnels de la santé orthopédique et chirurgicale

Le segment de clientèle ciblé comprend 48 700 professionnels.

Spécialité	Total des professionnels
Chirurgiens orthopédistes	29,300
Chirurgiens généraux	19,400

Distributeurs pharmaceutiques

Les principaux canaux de distribution comprennent 3 grossistes pharmaceutiques majeurs.

• Amerisourcebergen
• Santé cardinale
• McKesson Corporation

Institutions de recherche

Institutions de recherche ciblées pour les essais et études cliniques potentiels: 287

Type d'institution	Nombre d'institutions
Centres médicaux académiques	124
Installations de recherche indépendantes	163

Avenue Therapeutics, Inc. (ATXI) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Avenue Therapeutics a déclaré des dépenses de R&D de 7,4 millions de dollars.

Année	Dépenses de R&D	Pourcentage des dépenses totales
2022	6,2 millions de dollars	45.3%
2023	7,4 millions de dollars	48.6%

Investissements d'essais cliniques

Les investissements en essais cliniques pour IV Tramadol au cours de 2023 s'élevaient à 4,9 millions de dollars.

• Budget des essais cliniques de phase III: 3,2 millions de dollars
• Coûts de recrutement des patients: 1,1 million de dollars
• Frais de documentation réglementaire: 0,6 million de dollars

Coûts de conformité réglementaire

Les dépenses totales de conformité réglementaire pour 2023 étaient de 1,5 million de dollars.

Catégorie de conformité	Coût
Frais de demande de la FDA	0,7 million de dollars
Juridique et consultant	0,5 million de dollars
Équipe de conformité interne	0,3 million de dollars

Fabrication et production

Les coûts de fabrication pour IV Tramadol en 2023 ont totalisé 2,3 millions de dollars.

• Procurement des matières premières: 1,1 million de dollars
• Frais généraux des installations de production: 0,8 million de dollars
• Processus de contrôle de la qualité: 0,4 million de dollars

Opérations de marketing et de vente

Les frais de marketing et de vente pour 2023 étaient de 1,6 million de dollars.

Activité marketing	Coût
Compensation de l'équipe de vente	0,9 million de dollars
Marketing numérique	0,4 million de dollars
Participation de la conférence médicale	0,3 million de dollars

Avenue Therapeutics, Inc. (ATXI) - Modèle d'entreprise: Strots de revenus

Ventes de produits pharmaceutiques

Au quatrième trimestre 2023, Avenue Therapeutics s'est concentrée sur IV Tramadol, sans revenus de produits commerciaux signalés. Le chiffre d'affaires total pour 2023 était de 0 $.

Licence de propriété intellectuelle

Partenaire de licence	Détails de l'accord	Revenus potentiels
Coeptis Pharmaceuticals	Contrat de licence IV Tramadol	Paiement initial de 14 millions de dollars

Accords de redevances futurs potentiels

Structure potentielle des redevances pour IV Tramadol en attente d'approbation de la FDA et de lancement commercial.

Grants de recherches et collaborations

Aucune subvention de recherche significative indiquée dans les états financiers de 2023.

Revenus de partenariat stratégique

• Coeptis Pharmaceuticals Partnership for IV Tramadol Commercialisation
• Payments d'étape potentiels contingents sur les approbations réglementaires

Total des revenus de l'entreprise pour l'exercice 2023: 14 millions de dollars à partir du paiement de licence initiale.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Value Propositions

You're looking at the core value drivers for Avenue Therapeutics, Inc. (ATXI) as of late 2025, which is a story of extreme focus driven by acute financial reality. The entire value proposition hinges on one asset, IV tramadol, and the company's recent, drastic actions to preserve capital for its final push.

IV tramadol as a non-opioid alternative for post-operative acute pain

The primary value proposition is delivering an intravenous (IV) formulation of tramadol for managing moderate-to-moderately-severe acute post-operative pain in a medically supervised setting. This is positioned directly against established standards of care in the hospital environment.

• The Phase 3 safety study protocol, agreed upon with the FDA, involves a 300-patient non-inferiority trial.
• The study design compares IV tramadol against IV morphine for pain relief over a 48-hour post-operative period in bunionectomy patients.
• The estimated cost to execute this required Phase 3 safety study is $3 million.

Potential for reduced dependency risks compared to conventional opioids

The clinical argument for IV tramadol centers on its mechanism of action, aiming to offer effective analgesia while mitigating the dependency concerns associated with traditional Schedule II opioids. The FDA's requirement for the new Phase 3 study specifically targets this risk profile.

The value proposition is directly tied to demonstrating a favorable safety profile, particularly concerning opioid stacking risk, relative to a standard like IV morphine. Success here unlocks a market segment actively seeking opioid-sparing options.

Focused development on a single, late-stage asset for clear market entry

Avenue Therapeutics, Inc. has executed a complete strategic pivot, confirming an all-in strategy on IV tramadol. This singular focus simplifies the near-term path, though it concentrates all execution risk onto this one program. Honestly, when cash is this tight, you have to be this focused.

Here's the quick math on the pivot, based on the nine months ended September 30, 2025:

Metric	Value (9M Ended 9/30/2025)	Context
Cash Balance	$3.7 million	Insufficient to fund operations for the next 12 months; led to a 'going concern' warning.
R&D Expenses	$0.8 million	A dramatic 87% collapse from $6.1 million in the prior comparable period.
Market Capitalization	$1.34 MM	As of November 21, 2025, reflecting the high-risk status following the July 2025 Nasdaq delisting.

What this estimate hides is the immediate need for financing to even start the required Phase 3 trial, which costs an estimated $3 million.

Monetization of non-core assets (e.g., BAER-101) to fund core program

To fund the IV tramadol path, Avenue Therapeutics, Inc. has monetized its other pipeline assets, specifically through the sale of its subsidiary, Baergic Bio, which held BAER-101 and AJ201. This transaction was announced on November 6, 2025, with Axsome Therapeutics. This action directly converted non-core potential into immediate, albeit small, capital.

• Upfront payment received from Axsome Therapeutics for the Baergic Bio sale: $0.3 million.
• Total potential future milestone payments from the sale: Up to $2.5 million.
• BAER-101 was planned for a Phase 2a trial in focal epilepsy, subject to financing, but is now part of the divested assets.

Finance: draft 13-week cash view by Friday.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Customer Relationships

You're looking at the relationships Avenue Therapeutics, Inc. (ATXI) maintains, which are heavily weighted toward institutional and regulatory bodies given its pre-commercial status as of late 2025. Direct customer interaction, meaning with patients or end-users of their drugs, is minimal right now.

High-touch investor relations to manage funding and OTC market presence

Managing investor trust is critical when you are actively seeking financing and trading on the over-the-counter (OTC) market, which Avenue Therapeutics, Inc. (ATXI) has been doing since March 2025. The relationship management focuses on transparency regarding ongoing operational burn and strategic milestones. For instance, the Q3 2025 earnings report showed a net loss of $683,000 for the quarter, an improvement from the $3.1 million loss in the same period last year, which is a key data point for current holders. The Net Income (Loss) for the quarter ended September 30, 2025, was reported as $-2.22 million. As of November 18, 2025, the Current Market Cap stood at $2.42M. This necessitates focused communication around securing additional funding to support operations, like the potential Phase 3 safety study for IV tramadol.

Formal investor communication is structured around key corporate events:

• 2025 Annual Meeting of Stockholders set for December 30, 2025.
• Deadline for stockholders to submit proposals for the proxy statement is November 28, 2025.
• The company is headquartered at 1111 Kane Concourse, Suite 301, Bay Harbor Islands, FL 33154 for official correspondence.

The technical sentiment signal as of mid-November 2025 was noted as Sell, underscoring the need for clear, proactive investor engagement to manage expectations around fundamental weaknesses like negative earnings.

Direct, formal communication with regulatory bodies like the FDA

The relationship with the U.S. Food and Drug Administration (FDA) is highly formal and protocol-driven, centered on advancing the IV tramadol program. Avenue Therapeutics, Inc. (ATXI) reached a final agreement with the FDA on the Phase 3 safety study protocol and statistical analysis approach for IV tramadol on January 4, 2024. This agreement dictates the structure of the next critical step for potential approval.

Key parameters of this formal interaction include:

• The study is a non-inferiority design comparing IV tramadol to IV morphine.
• The study will randomize approximately 300 post bunionectomy patients.
• A prior Type C meeting with the FDA regarding IV Tramadol development occurred on March 9, 2023.

The company's CEO noted the collaborative nature of working with the FDA to address the theoretical risk of opioid-induced respiratory depression.

Strategic relationships with potential commercialization partners

This area saw a major recent development in November 2025, shifting the relationship focus from internal development to external commercialization through an asset sale. Avenue Therapeutics, Inc. (ATXI) announced the acquisition of its majority-owned subsidiary, Baergic Bio, by Axsome Therapeutics, Inc. This transaction secures a path for the development of BAER-101 (now AXS-17) for epilepsy.

The financial structure of this strategic relationship is detailed below:

Deal Component	Value/Terms
Upfront Payment to Baergic Shareholders	$0.3 million (less transaction expenses)
Total Potential Development/Regulatory Milestones	Up to $2.5 million (first indication)
Total Potential Sales-Based Milestones	Up to $79 million
Total Potential Milestone Payments	Approximately $82 million
Royalty Structure	Tiered mid-to-high single digit royalty on global net sales
Avenue Therapeutics Expected Share	Approximately 74% of all future payments and royalties

This deal validates the company's model of sourcing high-impact therapies while creating shareholder value through strategic divestiture.

Minimal direct customer interaction in the pre-commercial stage

As a development-stage specialty pharmaceutical company, Avenue Therapeutics, Inc. (ATXI) currently has no revenue from product sales. Customer relationships are effectively non-existent in the traditional sense, as the focus remains on clinical trials and regulatory submissions for assets like IV tramadol and AJ201. The company did report other revenue of $1.4 million for the nine months ended September 30, 2025, but this was explicitly related to a terminated license agreement with AnnJi Pharmaceutical Co. Ltd., not product sales to end-users. The primary 'customers' in the near term are the investigators and patients enrolled in the planned Phase 3 safety study for IV tramadol, which involves approximately 300 patients.

Finance: review cash runway based on Q3 2025 burn rate and Axsome upfront payment by Monday.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Channels

You're looking at how Avenue Therapeutics, Inc. (ATXI) gets its information, its assets, and its potential products to the relevant parties as of late 2025. The channels have definitely shifted, especially given the recent corporate transaction.

Over-the-Counter (OTC) Market for Stock Trading

Avenue Therapeutics, Inc. stock is no longer on a major exchange. Trading was suspended on The Nasdaq Capital Market on March 19, 2025, after the company failed to maintain the minimum stockholders' equity of $2,500,000; the reported equity as of September 30, 2024, was $1,652,000. The stock transitioned to the OTC Markets system on that same date under the ticker OTC:ATXI. The stock price as of November 26, 2025, was $0.76. The market capitalization as of November 18, 2025, stood at $2.42M. This market access is the primary channel for public equity trading now.

Here's a quick look at the public trading structure as of mid-November 2025:

Metric	Value (as of November 2025)
Trading Venue	OTC Markets (OTC:ATXI)
Stock Price (as of Nov 26, 2025)	$0.76
Market Capitalization (as of Nov 18, 2025)	$2.42M
Float	2.83M
Institutions Ownership	3.15%
Short Percent	2.83%

SEC Filings and Press Releases for Investor Communication

Investor communication flows through mandatory regulatory disclosures and corporate announcements. Avenue Therapeutics, Inc. has set its 2025 annual meeting of stockholders for December 30, 2025. The deadline for shareholders to submit proposals for inclusion in the proxy statement under Rule 14a-8 was November 28, 2025. The company filed an 8-K on November 18, 2025, detailing corporate governance matters. The most recent material event reported via an 8-K on November 12, 2025, concerned the definitive agreement to sell its majority-owned subsidiary, Baergic Bio.

Key recent regulatory filing dates include:

• Filing of 10-Q (Quarterly Report): November 13, 2025.
• Filing of 8-K (Material Event): November 18, 2025.
• Last reported financial results (Q3 2024 10-Q): November 14, 2024.

Clinical Trial Sites and Investigators for Drug Development

The development pipeline relies on clinical sites and investigators to generate data. For the AJ201 Phase 1b/2a trial in Spinal and Bulbar Muscular Atrophy (SBMA), 25 patients were enrolled across six clinical sites in the U.S. The company thanked trial investigators for completing this study on schedule in May 2024. For the IV tramadol Phase 3 safety study, the plan involved randomizing approximately 300 post bunionectomy patients.

The broader ecosystem supporting these activities shows significant market scale:

• Clinical Trial Investigative Site Network Market Size (2024): USD 8.5 Bn.
• Predicted Clinical Trial Investigative Site Network Market Size (2034): USD 17.5 Bn.
• Therapeutic Areas of Focus: Central Nervous System (CNS) and Pain & Inflammation.

Future Pharmaceutical Sales Force (Likely Partnered) for Commercialization

Commercialization channels for Avenue Therapeutics, Inc.'s assets are largely structured through partnerships following recent divestitures. Axsome Therapeutics obtained worldwide commercial rights to BAER-101 (re-designated as AXS-17) as part of the Baergic Bio sale. Avenue Therapeutics, Inc. is positioned to receive value through milestones and royalties from this partner, meaning Axsome will manage the ultimate sales force channel.

The potential financial upside channel from the AXS-17 agreement includes:

• Upfront payment received: $0.3 million (less fees).
• Development/Regulatory Milestones (First Indication): Up to $2.5 million.
• Commercial Sales Milestones: Up to $79 million.
• Royalty Structure: A tiered mid-to-high single-digit royalty on potential global net sales.
• Avenue Therapeutics, Inc. expected share of all future payments/royalties: Approximately 74%.

For IV tramadol, the path to commercialization was previously noted as subject to obtaining necessary financing, potentially through a strategic partnership. The company is headquartered in Miami, FL.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Customer Segments

You're looking at the customer base for Avenue Therapeutics, Inc. (ATXI) as of late 2025. Given the company's current financial posture-a cash balance of just $3.7 million as of September 30, 2025, and a market capitalization of $2.42 million-the focus is intensely narrow, directly impacting how they approach each segment.

Hospitals and surgical centers managing acute post-operative pain.

This segment represents the primary commercial target for the company's lead asset, IV Tramadol, intended for use in a medically supervised healthcare setting for moderate-to-moderately-severe pain management following surgery. The company's entire operational focus is currently channeled toward this product, evidenced by the dramatic 87% collapse in research and development expenses-down to $0.8 million for the first nine months of 2025.

The immediate requirement to serve this segment hinges on securing funding for the final regulatory step:

• Estimated cost for the required new Phase 3 safety study: $3 million.
• The study protocol involves a 300-patient non-inferiority trial.

Pain management specialists and anesthesiologists.

These are the prescribers and administrators who would utilize IV Tramadol for rapid, effective acute pain relief. Their adoption hinges on the clinical profile of the IV formulation versus existing standards of care. The company's ability to engage this segment commercially is entirely dependent on successfully navigating the financing hurdle to complete the necessary safety trial.

The company's strategic pivot confirms this focus:

• R&D spend dropped from $6.1 million to $0.8 million for the nine months ended September 30, 2025.
• The company is obligated to pay Fortress Biotech a 2.5% Annual Equity Fee, which accounted for $0.7 million in G&A expense for the first nine months of 2025, diverting scarce capital.

Institutional and retail investors in the specialty pharmaceutical sector.

This segment is currently characterized by high risk due to the company's liquidity crisis and recent delisting from Nasdaq in July 2025. The investment thesis is now almost entirely tied to the successful financing and subsequent approval of IV Tramadol, or the realization of contingent value from prior asset sales.

Here are the key financial metrics defining the current investor landscape for Avenue Therapeutics, Inc. (ATXI):

Metric	Value as of Late 2025 Data
Current Market Cap	$2.42 million
Cash Balance (Sep 30, 2025)	$3.7 million
Analyst Coverage	2 analysts
Weekly Share Price Volatility (Past Year)	Decreased from 26% to 17%
Contingent Value from BAER-101 Sale (Potential)	74% share of up to $225 million in milestones

Patients requiring moderate-to-moderately-severe pain management.

This segment represents the ultimate beneficiary of the product, requiring prompt relief in acute settings. While direct patient volume statistics for the target indication are not publicly detailed for Avenue Therapeutics, Inc. (ATXI), the product's positioning is to offer a novel treatment option for patients undergoing surgical procedures or suffering from severe acute conditions.

The company's focus on IV administration suggests a target population where rapid onset of action is critical, such as:

• Patients in the immediate post-operative recovery phase.
• Patients in emergency or acute care settings needing immediate analgesia.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Cost Structure

You're looking at the cost side of Avenue Therapeutics, Inc. (ATXI) as of the third quarter of 2025. For a clinical-stage biotech, the cost structure is almost entirely focused on development, compliance, and keeping the lights on while pursuing financing. Honestly, the numbers show a very lean operation for the period.

The Total Operating Expenses for the three months ended September 30, 2025, were reported at $724,000. This figure is significantly lower than the $3,156,000 reported for the same period in 2024, reflecting a major shift in spending priorities or program status.

Here's a breakdown of the key components of that cost structure for Q3 2025, in thousands of US dollars:

Expense Category	Q3 2025 Amount (in thousands)	Q3 2025 Amount (Actual USD)	Q3 2024 Amount (in thousands)
Research and Development (R&D)	$177	$177,000	$2,327
General and Administrative (G&A)	$547	$547,000	$829
Total Operating Expenses	$724	$724,000	$3,156

The Research and Development (R&D) spend for the quarter was $177,000. This is a sharp drop from the $2,327,000 in R&D costs seen in Q3 2024. This lower R&D spend reflects the company's current stage, especially concerning the IV tramadol program, which is contingent on securing additional financing or a partnership before initiating the Phase 3 safety study.

General and Administrative (G&A) expenses for the quarter were $547,000. While lower than the $829,000 in Q3 2024, G&A remains a critical, fixed-like cost base for a public pharmaceutical company.

Costs associated with initiating and running the IV tramadol Phase 3 trial are currently deferred, as the initiation of the Phase 3 safety study, which involves approximately 300 post-bunionectomy patients, is pending financing or a partnership. However, past costs are embedded in the R&D line item. For instance, for the six months ended June 30, 2025, R&D expenses decreased by $3.2 million compared to the prior year, which included a $0.1 million decrease in IV tramadol supply costs.

Legal and defintely regulatory compliance costs are a constant in this industry, and for Avenue Therapeutics, Inc., these are captured within the G&A structure. These costs cover:

• Professional fees for legal and consulting services.
• Costs associated with seeking potential regulatory approval and commercialization.
• Costs related to public reporting company requirements.
• Compliance with federal and state healthcare laws, including fraud and abuse regulations.

To be fair, maintaining Nasdaq listing compliance also drives certain administrative and legal overhead, which you see reflected in the $547,000 G&A spend for the quarter.

Finance: draft 13-week cash view by Friday.

Avenue Therapeutics, Inc. (ATXI) - Canvas Business Model: Revenue Streams

The Revenue Streams for Avenue Therapeutics, Inc. as of late 2025 are primarily non-product related, stemming from asset divestitures and licensing agreements, as the company focuses on its IV tramadol development.

No product revenue was reported by Avenue Therapeutics, Inc. in the third quarter of 2025. The company's current financial structure relies heavily on contingent payments from prior transactions to fund its ongoing operations, especially following its delisting from Nasdaq in March 2025.

The primary expected future income streams are tied to the sale of its majority-owned subsidiary, Baergic Bio, to Axsome Therapeutics, Inc., which holds the rights to BAER-101 (AXS-17).

Revenue Source Component	Potential Value/Amount	Notes
Total Potential Milestones (Axsome/BAER-101)	Up to $84.5 million	Includes development, regulatory, and sales milestones from Axsome Therapeutics for AXS-17.
Avenue Therapeutics Expected Share (Axsome)	Approximately 74%	Of all future payments and royalties from the Axsome agreement.
AnnJi License Termination Payment (YTD 9M 2025)	$1.4 million	Received in the first nine months of 2025 from the termination of the AJ201 license agreement.
Upfront Payment (Axsome/BAER-101)	$0.3 million	Upfront payment received by Baergic shareholders (Avenue's share is $\sim 74\%$) less transaction expenses.

The company also has potential future revenue from the terminated AJ201 agreement with AnnJi Pharmaceutical, though the $1.4 million received in the first nine months of 2025 appears to be a key component of that settlement.

The potential future payments from the AnnJi termination include:

• Payments up to $5 million in aggregate for development and regulatory milestones for AJ201.
• Payments up to $17 million in aggregate for commercial sales milestone events for AJ201.
• A 1.75% royalty on net sales of AJ201.
• Up to $7.5 million from 15% of payments AnnJi receives from any subsequent third-party licenses.
• A minimum of $4 million owing under a specific mechanism if a New Drug Application is approved in the U.S. for AJ201.

To bridge the gap until potential milestone or royalty payments are realized, Avenue Therapeutics, Inc. relies on proceeds from equity financing. Management has noted that current cash levels are insufficient to fund operations beyond 12 months without additional capital, underscoring the importance of these financing activities to sustain operations.