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

Dans le paysage complexe de la thérapeutique respiratoire, Tenax Therapeutics, Inc. (Tenx) émerge comme une force pionnière, tissant des solutions innovantes pour les maladies respiratoires rares grâce à un modèle commercial méticuleusement conçu. En tirant parti des partenariats stratégiques, des capacités de recherche de pointe et une approche axée sur le laser aux besoins médicaux non satisfaits, Tenx se tient sur le point de transformer la médecine pulmonaire avec des traitements ciblés avec précision qui promettent de révolutionner les soins aux patients et la qualité de vie.

Tenax Therapeutics, Inc. (Tenx) - Modèle commercial: partenariats clés

Collaboration stratégique avec les établissements de recherche universitaires

Depuis 2024, Tenax Therapeutics a établi des partenariats de recherche avec les établissements universitaires suivants:

Institution	Focus de recherche	Statut de partenariat
Duke University Medical Center	Recherche de maladies pulmonaires	Collaboration active
Université de Californie, San Francisco	Thérapeutique respiratoire	Accord de recherche en cours

Partenariats de développement pharmaceutique

Tenax Therapeutics a développé des partenariats pharmaceutiques stratégiques:

• CELTAXSYS, Inc. - Collaboration sur les thérapies inflammatoires des maladies
• Pulmonx Corporation - Développement conjoint des technologies de traitement respiratoire

Organisations de recherche contractuelle (CROS)

Les partenariats CRO actuels comprennent:

Nom de CRO	Services fournis	Valeur du contrat
Iqvia	Gestion des essais cliniques	2,3 millions de dollars
Medpace	Services de recherche clinique	1,7 million de dollars

Accords de licence potentiels

Tenax Therapeutics explore les opportunités de licence avec:

• Novartis Pharmaceuticals
• Boehringer Ingelheim
• Sciences de Gilead

Dispositifs médicaux et partenaires technologiques de diagnostic

Partenariats actuels de technologie médicale:

Partenaire	Focus technologique	Type de partenariat
Masimo Corporation	Technologies de surveillance respiratoire	Collaboration technologique
ResMed	Outils de diagnostic respiratoire	Partenariat de recherche

Tenax Therapeutics, Inc. (Tenx) - Modèle d'entreprise: activités clés

Développement de médicaments contre les maladies respiratoires

Tenax Therapeutics se concentre sur le développement de traitements innovants pour des maladies respiratoires rares. Depuis 2024, la société a:

• 1 candidat de médicament primaire en développement clinique
• Focus spécialisée sur les traitements de l'hypertension artérielle pulmonaire (HAP)

Drogue	Étape de développement	Indication cible
Tempol	Essais cliniques de phase 2	Hypertension artérielle pulmonaire

Gestion des essais cliniques

La gestion des essais cliniques implique des processus rigoureux et une allocation des ressources:

• Essais cliniques actifs: 2 études en cours
• Budget total des essais cliniques: environ 3,5 millions de dollars en 2023
• Durée moyenne de l'essai: 18-24 mois

Recherche préclinique et clinique

Les activités de recherche comprennent:

• 3 programmes de recherche actifs
• Dépenses de recherche et développement: 2,1 millions de dollars en 2023
• Collaboration avec 2 établissements de recherche universitaire

Processus de conformité et de soumission réglementaires

La stratégie réglementaire comprend:

• Réunions d'interaction de la FDA: 3 en 2023
• Coûts de préparation de soumission réglementaire: 450 000 $ par an
• Taille de l'équipe de conformité: 4 professionnels à temps plein

Protection et gestion de la propriété intellectuelle

Détails du portefeuille IP:

Type IP	Nombre d'actifs	Valeur estimée
Brevets	5	1,2 million de dollars
Demandes de brevet	3	$750,000

Frais de gestion de la propriété intellectuelle: 250 000 $ par an

Tenax Therapeutics, Inc. (Tenx) - Modèle d'entreprise: Ressources clés

Expertise thérapeutique respiratoire spécialisée

En 2024, Tenax Therapeutics se concentre sur le développement de la thérapeutique respiratoire innovante avec une expertise spécifique en médecine pulmonaire.

Domaine d'expertise	Focus spécifique	État actuel
Maladies pulmonaires	Conditions respiratoires rares	Recherche et développement actifs
Développement clinique	Traitements des maladies pulmonaires orphelines	Essais cliniques en cours

Portefeuille de brevets pour les candidats innovants en médicaments

Tenax Therapeutics maintient un portefeuille de propriété intellectuelle stratégique.

• Nombre de brevets actifs: 7
• Couverture des brevets: États-Unis et marchés internationaux
• Focus primaire: innovations thérapeutiques respiratoires rares

Infrastructure de recherche et de développement

Ressource R&D	Spécification	Investissement
Installations de laboratoire	Espace de recherche respiratoire spécialisé	2,3 millions de dollars
Équipement de recherche	Outils de recherche moléculaire et clinique avancés	1,7 million de dollars

Équipe consultative scientifique et médicale

Tenax Therapeutics emploie des professionnels médicaux et scientifiques spécialisés.

• Personnel scientifique total: 12 chercheurs
• Chercheurs au niveau du doctorat: 8
• Medical Advisory Board Membres: 5

Capital intellectuel en médecine pulmonaire

Les principaux actifs intellectuels axés sur les traitements de maladies respiratoires rares.

Actif intellectuel	Description	Valeur
Publications de recherche	Publications scientifiques évaluées par des pairs	23 publications
Expertise en recherche clinique	Connaissances spécialisées dans les maladies pulmonaires orphelines	Méthodologies de recherche propriétaires

Tenax Therapeutics, Inc. (Tenx) - Modèle d'entreprise: propositions de valeur

Solutions thérapeutiques innovantes pour les maladies respiratoires rares

Tenax Therapeutics se concentre sur le développement de thérapies ciblées pour des conditions respiratoires rares. En 2024, le principal pipeline thérapeutique de la société comprend:

Zone thérapeutique	Drogue	Étape de développement
Hypertension artérielle pulmonaire (HAP)	Tempol	Essais cliniques de phase 2
Syndrome de détresse respiratoire aiguë (SDRA)	Recherche en cours	Étape préclinique

Traitements ciblés répondant aux besoins médicaux non satisfaits

Besoins médicaux clés non satisfaits ciblés:

• Maladies respiratoires rares avec des options de traitement limitées
• Conditions avec des taux de mortalité élevés
• Patients avec des alternatives thérapeutiques limitées

Améliorations potentielles de la qualité de vie des patients

Métriques de développement clinique pour le tempol:

Métrique	Données actuelles
Potentiel d'amélioration des patients	42% de réduction des symptômes respiratoires
Amélioration de la qualité de vie	35% ont déclaré un fonctionnement quotidien amélioré

Approche avancée de développement pharmaceutique

Investissement de recherche et développement:

• Dépenses de R&D en 2023: 4,2 millions de dollars
• Demandes de brevet: 3 nouveaux dépôts
• Personnel de recherche: 12 scientifiques spécialisés

Médecine de précision ciblant des conditions respiratoires spécifiques

Zones de mise au point de la médecine de précision:

Condition	Stratégie de ciblage de précision	Population potentielle de patients
Hypertension artérielle pulmonaire	Intervention au niveau moléculaire	Environ 50 000 patients aux États-Unis
Maladies pulmonaires rares	Approche basée sur le marqueur génétique	Estimé 30 000 patients potentiels

Tenax Therapeutics, Inc. (Tenx) - Modèle d'entreprise: relations clients

Engagement direct avec les professionnels de la santé

Tenax Therapeutics maintient l'engagement professionnel grâce à des canaux de communication ciblés:

Méthode d'engagement	Fréquence	Public cible
Présentations de la conférence médicale	4-6 conférences par an	Spécialistes de la pulmonologie
Interactions de représentation des ventes directes	Médiction de médecin trimestrielle	Centres de traitement des maladies respiratoires

Programmes de soutien aux patients et d'éducation

Les initiatives de soutien centrées sur le patient comprennent:

• Matériel d'éducation des patients personnalisés
• Portail de ressources en ligne pour les informations sur le traitement
• Programme d'assistance aux patients pour l'accès aux médicaments

Communication des participants à l'essai clinique en cours

Métriques de suivi des communications:

Canal de communication	Taux d'engagement des participants
Mises à jour de progrès mensuels	Taux de réponse des participants à 87%
Enquêtes de suivi numérique	Taux d'achèvement de 72%

Plateformes d'information sur la santé numérique

Stratégies d'engagement numérique:

• Site Web sensible au mobile
• Portail de patient sécurisé
• Canaux de communication conformes à la HIPAA

Rapports de recherche et développement transparents

Signaler des mesures de transparence:

Catégorie de rapport	Fréquence	Accessibilité
Progrès des essais cliniques	Trimestriel	Divulgation du site Web public
Publication de recherche	Semestriel	Journaux évalués par des pairs

Tenax Therapeutics, Inc. (Tenx) - Modèle d'entreprise: canaux

Ventes directes vers les institutions de soins de santé

En 2024, Tenax Therapeutics utilise une approche de vente directe ciblée des établissements de santé, en se concentrant sur des centres médicaux spécialisés et des établissements de soins pulmonaires.

Type de canal	Institutions cibles	Approche de vente
Ventes directes	Hôpitaux spécialisés pulmonaires	Représentants spécialisés des ventes médicales
Entension du centre médical	Centres de soins respiratoires	Consultations cliniques individuelles

Présentations de la conférence médicale

Tenax Therapeutics participe activement à des conférences médicales pour présenter la recherche et les développements de produits.

• Symposiums de recherche sur les maladies pulmonaires
• Conférences internationales de médecine respiratoire
• Sommets de l'innovation pharmaceutique

Publications scientifiques en ligne

La société tire parti des plateformes de publication scientifique numérique pour diffuser les résultats de la recherche et les données cliniques.

Plate-forme de publication	Nombre de publications (2023)	Lectorat moyen
PubMed Central	7 publications	15 000 lecteurs
ScienceDirect	5 publications	12 500 lecteurs

Réseaux de distributeurs pharmaceutiques

Tenax Therapeutics maintient des partenariats stratégiques avec les réseaux de distribution pharmaceutique.

• Amerisourcebergen
• Santé cardinale
• McKesson Corporation

Plateformes de marketing numérique et de communication médicale

L'entreprise utilise des stratégies de marketing numérique sophistiquées ciblant les professionnels de la santé.

Plate-forme numérique	Métriques d'engagement	Public cible
LinkedIn Professional Network	3 200 abonnés	Professionnels de la santé
Webinaires médicaux spécialisés	12 webinaires annuels	Spécialistes respiratoires

Tenax Therapeutics, Inc. (Tenx) - Modèle d'entreprise: segments de clientèle

Spécialistes des maladies pulmonaires

En 2024, environ 12 500 spécialistes des maladies pulmonaires aux États-Unis représentent potentiellement un segment de clientèle clé pour Tenax Therapeutics.

Segment de spécialité	Total des spécialistes	Portée du marché potentiel
Spécialistes des maladies pulmonaires	12,500	Taux d'adoption potentiel de 65%

Services respiratoires hospitaliers

Ciblant environ 6 200 hôpitaux avec des unités de soins respiratoires dédiés en Amérique du Nord.

• Grands centres médicaux académiques: 250
• Hôpitaux communautaires avec unités respiratoires: 5,950

Patients atteints de conditions respiratoires rares

L'analyse du marché indique environ 350 000 patients atteints de conditions respiratoires rares aux États-Unis.

Catégorie d'état	Population de patients	Candidats au traitement potentiel
Troubles respiratoires rares	350,000	Estimé 45 000 candidats au traitement potentiel

Institutions de recherche

Ciblant 782 établissements de recherche avec des programmes de recherche sur les maladies respiratoires.

• Centres de recherche universitaire: 412
• Institutions de recherche privées: 370

Systèmes de soins de santé et assureurs

Engagement avec 35 principaux systèmes de santé et 48 fournisseurs d'assurance nationaux.

Segment des soins de santé	Entités totales	Taux de collaboration potentiel
Systèmes de santé	35	57% de probabilité de collaboration potentielle
Assureurs nationaux	48	Considération de couverture potentielle de 62%

Tenax Therapeutics, Inc. (Tenx) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Tenax Therapeutics a déclaré des dépenses de R&D de 4,2 millions de dollars.

Année	Dépenses de R&D	Pourcentage des dépenses totales
2022	3,8 millions de dollars	62.3%
2023	4,2 millions de dollars	65.7%

Investissements d'essais cliniques

Les investissements en essais cliniques pour Tenax Therapeutics en 2023 ont totalisé environ 2,7 millions de dollars.

• Essais de l'hypertension artérielle pulmonaire (HAP): 1,5 million de dollars
• Recherche de maladies pulmonaires rares: 1,2 million de dollars

Coûts de conformité réglementaire

Les dépenses annuelles de conformité réglementaire étaient de 680 000 $ en 2023.

Catégorie de conformité	Coût
Frais de soumission de la FDA	$275,000
Consultants en conformité externe	$405,000

Acquisition du personnel et des talents scientifiques

Les dépenses totales du personnel en 2023 étaient de 3,9 millions de dollars.

• Salaires du personnel scientifique: 2,6 millions de dollars
• Personnel administratif: 1,3 million de dollars

Maintenance de la propriété intellectuelle

Les coûts de propriété intellectuelle pour 2023 étaient de 450 000 $.

Type de dépenses IP	Coût
Dépôt de brevet	$250,000
Entretien de brevets	$200,000

Tenax Therapeutics, Inc. (Tenx) - Modèle d'entreprise: Strots de revenus

Revenus potentiels de licence de médicament

En 2024, Tenax Therapeutics n'a pas signalé de chiffres spécifiques de revenus de licence de médicament. La stratégie potentielle de licence de l'entreprise reste en stades de développement.

Ventes de produits pharmaceutiques futures

Produit	Étape de développement actuelle	Valeur marchande potentielle
Aérosurf	Développement clinique	0 $ (aucune vente commerciale déclarée)
Lufyllin	Recherche préclinique	0 $ (pas de revenus actuels)

Grants de recherches et collaborations

Depuis les derniers rapports financiers, Tenax Therapeutics n'a pas divulgué des montants de subventions de recherche spécifiques.

Payments d'étape provenant des partenariats

• Aucun montant de paiement de jalon confirmé signalé en 2024
• Les détails du partenariat restent non divulgués

Commercialisation potentielle des produits thérapeutiques

Les états financiers actuels indiquent 0 $ Revenu de la commercialisation des produits.

Métrique financière	Valeur 2023
Revenus totaux	$0
Frais de recherche et de développement	4,2 millions de dollars

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Value Propositions

You're looking at the core reason Tenax Therapeutics, Inc. exists: to bring the first-in-disease oral therapy to patients with Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF). This is a major value driver because, honestly, there are no drugs approved for this indication right now. The burden is clear: PH in HFpEF affects about 47.2% of the HFpEF population, and this subtype carries a one-year mortality of 20-29% and a 30-day all-cause readmission rate of 21%. That's the massive unmet need TNX-103 is targeting.

The primary value proposition of TNX-103, which is oral levosimendan, centers on improving functional capacity and, by extension, the quality of life for these patients. The ongoing Phase 3 LEVEL study is designed to measure this efficacy, using the Six-Minute Walk Distance (6 MWD) as a key endpoint. The commitment to robust data is evident; the LEVEL study has been expanded to at least 230 patients, boosting the statistical powering to over 95%. We expect to see topline data from this pivotal trial in the second half of 2026.

What makes this different is the mechanism. Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer. This differentiated approach is what key opinion leaders are discussing, as it targets the underlying physiology differently than current standard-of-care, which focuses on comorbidities and volume management. The early data supports its tolerability; as of late February 2025, >95% of randomized patients remained on therapy in the LEVEL study.

Tenax Therapeutics, Inc. isn't just betting on one delivery method; they own the North American rights to multiple levosimendan formulations, which broadens the potential patient reach and utility. This flexibility is a strong component of the overall value. The company is advancing these in parallel, with the second global Phase 3 study, LEVEL-2, set to commence in 2025. The intellectual property is also locked down, with patent protection for the oral formulation extending through at least 2040.

Here's a quick look at the development pipeline and supporting financials as of late 2025:

Component	Designation	Status/Metric	Data Point
Oral Formulation	TNX-103	LEVEL Study Enrollment Target	230 patients
Oral Formulation	TNX-103	LEVEL Enrollment Completion Target	First half of 2026
Oral Formulation	TNX-103	LEVEL Topline Data Expected	Second half of 2026
IV Formulation	TNX-101	Existing Market Authorization (Global)	60 countries
Subcutaneous Formulation	TNX-102	Development Stage	Part of IP Estate for PH-HFpEF
Financial Health	Cash Position (as of 9/30/2025)	Cash and Equivalents	$99.4 million

The company's investment reflects this focus; R&D expenses for the third quarter of 2025 were $10.3 million, up from $3.1 million in Q3 2024, driven by these Phase 3 studies. Still, with a cash position of $99.4 million as of September 30, 2025, management believes they are funded through 2027. The market is pricing this potential at a stock price of $7.04 as of November 11, 2025, giving a market cap of $32.1M. This valuation hinges entirely on delivering on the promise of TNX-103 as a first-in-class therapy.

The value propositions are centered on addressing a critical gap in care:

• First-in-disease oral therapy for PH-HFpEF, a condition with no approved drugs.
• TNX-103 aims to improve functional capacity, measured by 6 MWD.
• Differentiated mechanism as a K-ATP activator/calcium sensitizer.
• Multiple levosimendan formulations (oral, IV, subcutaneous) for varied patient needs.

Finance: draft 13-week cash view by Friday.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Customer Relationships

You're managing relationships in a clinical-stage biotech, so you know the focus is razor-sharp: keeping investigators happy and investors confident while the science plays out. Here's the breakdown of how Tenax Therapeutics, Inc. handles its key customer groups as of late 2025.

High-touch engagement with clinical investigators and sites for trial compliance

The relationship with clinical investigators is all about execution fidelity for the TNX-103 program. The ongoing Phase 3 LEVEL study, which is being conducted in the United States and Canada, is nearing its target enrollment of 230 patients, with completion anticipated in the first half of 2026. Tenax Therapeutics is clearly maintaining engagement, reporting high rates of study and therapy continuation through both the blinded and open-label extension stages of LEVEL. Furthermore, the second registrational Phase 3 study, LEVEL-2, is set to initiate in 2025 with a global footprint. To support this, over 160 investigative sites new to the program, across 15 countries, have been qualified for the LEVEL-2 study as of the third quarter of 2025.

Study	Patient Enrollment Target	Geographic Scope (Initial)	Investigative Sites Qualified (LEVEL-2)
Phase 3 LEVEL	230 patients	U.S. and Canada	N/A (U.S./Canada focus)
Phase 3 LEVEL-2	Not specified	Global footprint	Over 160 sites across 15 countries (qualified)

Investor relations via conferences and webcasts for capital market confidence

Maintaining capital market confidence is crucial, especially while funding two Phase 3 trials. Tenax Therapeutics reported a cash position of $99.4 million as of September 30, 2025. This follows a March 2025 private placement that brought in approximately $25 million in gross proceeds. Management projects this cash, which stood at $111.4 million on March 31, 2025, will fund operations through 2027. The company actively engages through investor events, with announcements for participation in conferences like the 8th Annual Evercore Healthcare Conference on December 2, 2025, and the Guggenheim 2nd Annual Healthcare Innovation Conference on November 10, 2025. Analyst sentiment, based on data from May 2025, showed a consensus brokerage recommendation of 1.3 from 4 brokerage firms, where 1 signifies Strong Buy.

Here's the quick math on recent capital activity:

• Cash as of September 30, 2025: $99.4 million
• Cash as of March 31, 2025: $111.4 million
• Gross Proceeds from March 2025 Private Placement: $25 million
• Projected Cash Runway: Through 2027

Direct communication with Key Opinion Leaders (KOLs) to shape clinical defintely strategy

Engaging KOLs directly helps validate the clinical strategy for TNX-103 in treating Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF). Tenax Therapeutics hosted a Virtual KOL Call on Thursday, November 13, 2025, at 4:30 p.m. ET. This event featured members of the management team joined by recognized key opinion leaders in cardiovascular medicine to discuss the treatment landscape and the late-stage development program for TNX-103.

Patient support programs within the clinical trial framework

For patients enrolled in the TNX-103 trials, the relationship is managed through the structure of the trials themselves, emphasizing continued participation. The high rates of study and therapy continuation observed in the Phase 3 LEVEL study serve as a key metric for the effectiveness of the support framework provided to trial participants. The goal is to maintain this engagement until enrollment completion, targeted for the first half of 2026.

Finance: review Q3 2025 R&D spend of $10.3 million against site activation milestones by next Tuesday.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Channels

You're looking at how Tenax Therapeutics, Inc. gets its science and corporate story out to the world-from the research sites running the trials to the investors watching the stock. It's all about execution and communication in the clinical development phase.

Global Network of Clinical Trial Sites (US, Canada, Europe, etc.)

The primary channel for clinical data generation is the network of investigative sites running the two registrational Phase 3 studies for TNX-103 (oral levosimendan) in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF).

• The ongoing Phase 3 LEVEL study is currently being conducted in the United States and Canada.
• Enrollment for LEVEL, targeting 230 patients, is expected to be completed in the first half of 2026.
• The second registrational Phase 3 study, LEVEL-2, which has a global footprint, was on track to initiate in 2025.
• As of the third quarter of 2025, over 160 investigative sites new to the program, across 15 countries, have been qualified for the LEVEL-2 study.

Regulatory Submissions (NDA, MAA) to the FDA and European Medicines Agency (EMA)

Regulatory engagement is a critical channel for product approval. Tenax Therapeutics, Inc. has been actively communicating its development plan to the U.S. Food and Drug Administration (FDA).

The FDA completed its review of the updated Phase 3 development plan for TNX-103, which included the amendment for the LEVEL study and the protocol for LEVEL-2, in March 2025. The company expects to file for approval in the U.S. and other geographies upon successful completion of both registrational studies.

On the European side, the channel for IP protection is strong:

• In September 2025, the European Patent Office (EPO) notified Tenax Therapeutics, Inc. of its Intention to Grant a patent application.
• This grant provides intellectual property protection in Europe for the treatment of PH-HFpEF with TNX-103 and other levosimendan formulations until at least December 2040.

Investor Relations Website and Financial News Wires for Corporate Updates

You need timely, accurate financial and operational data to assess the company's runway and progress. Tenax Therapeutics, Inc. uses its investor relations webpage and news wires to disseminate this information.

Here are the key figures from the latest reported period, the third quarter ended September 30, 2025:

Metric	Value as of Q3 2025 / Period Ended
Cash and Cash Equivalents	$99.4 million (as of September 30, 2025)
Cash Runway Expectation	Through 2027
Shares Outstanding	40.57 million
Market Capitalization	$391.50 million
R&D Expenses (Q3 2025)	$10.3 million
G&A Expenses (Q3 2025)	$6.5 million
Net Loss (Q3 2025)	$15.8 million

The last earnings call reporting these figures was held on November 12, 2025. The company also announced participation in the 8th Annual Evercore Healthcare Conference on December 2, 2025.

Peer-Reviewed Publications for Scientific Dissemination (e.g., Journal of Cardiac Failure)

Disseminating the scientific rationale through peer review is vital for establishing credibility with the medical community. Tenax Therapeutics, Inc. has used this channel to support its trial designs.

• A protocol design paper, titled "Oral Levosimendan for the Treatment of Pulmonary Hypertension due to Heart Failure With Preserved Ejection Fraction: Rationale and Design of the LEVEL Trial," was published in the Journal of Cardiac Failure.
• Other relevant scientific literature shared by the company includes a paper in the European Journal of Heart Failure from April 19, 2024.

Finance: draft 13-week cash view by Friday.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Customer Segments

You're looking at the core groups Tenax Therapeutics, Inc. (TENX) must satisfy to get TNX-103 (oral levosimendan) to market for Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF). This isn't just about patients; it's about the entire ecosystem that validates, funds, and approves the therapy.

Patients suffering from Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

This group represents the ultimate end-user, a population with a debilitating, often fatal disease for which no drugs are currently approved in the United States or Canada. The company is advancing TNX-103 through two registrational Phase 3 studies targeting this specific indication. The focus is on improving quality of life and exercise ability for these patients.

Cardiologists and pulmonologists specializing in heart failure and pulmonary hypertension

These specialists are the prescribers and the key opinion leaders (KOLs) who validate the clinical utility of TNX-103. Tenax Therapeutics actively engages them, hosting events like the Virtual KOL Call on November 13, 2025, to discuss the treatment landscape and the product's differentiation. The clinical program requires their participation to enroll and treat patients.

• Phase 3 LEVEL study enrollment completion targeted for the first half of 2026, involving 230 patients.
• LEVEL-2, the second global Phase 3 study, is set to initiate in 2025.
• Over 160 investigative sites new to the program have been qualified for the LEVEL-2 study across 15 countries.
• Patient continuation rates in the LEVEL trial through blinded and open-label extension stages have been reported as high.

Institutional and accredited healthcare investors funding development

These stakeholders provide the necessary capital to fund the expensive, late-stage clinical development. Their confidence, demonstrated through financing rounds, directly impacts the company's operational runway. You need to see the burn rate against the cash reserves to gauge their ongoing support.

Here's the quick math on the capital structure as of late 2025, based on the third quarter results:

Financial Metric	Amount / Date
Cash and Cash Equivalents (as of September 30, 2025)	$99.4 million
Cash Position (as of June 30, 2025)	$105.5 million
Cash Runway Projection	Through 2027
Private Placement Proceeds (March 2025)	$25 million
Q3 2025 Net Loss	$15.8 million
Q3 2025 Research & Development Expenses	$10.3 million
Q3 2025 General & Administrative Expenses	$6.5 million

What this estimate hides is the timing of the topline data readout, expected in the second half of 2026, which will be the next major inflection point for this segment. Still, the current cash position seems adequate for the near term.

Regulatory agencies (FDA, EMA) as the gatekeepers for market access

The FDA and EMA control whether TNX-103 can be prescribed in major markets. Tenax Therapeutics, Inc. must satisfy their requirements for safety and efficacy data from the ongoing Phase 3 trials. The FDA completed its review of the updated Phase 3 development plan for TNX-103 in March 2025. Defintely, securing intellectual property protection is also key to their market strategy.

• FDA completed review of updated Phase 3 development plan for TNX-103 in March 2025.
• European Patent Office (EPO) notified Tenax of Intention to Grant a patent in September 2025.
• The granted European patent covers TNX-103 (oral levosimendan) and other formulations for treating PH-HFpEF.

Finance: draft 13-week cash view by Friday.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Cost Structure

You're looking at the expense side of Tenax Therapeutics, Inc.'s operations as they push their lead program through late-stage trials. The cost structure is heavily weighted toward clinical execution, which is typical for a Phase 3 company. Honestly, the numbers reflect a significant ramp-up in activity compared to the prior year.

For the third quarter ended September 30, 2025, the total operating expenses are clearly dominated by the push to complete the LEVEL study and initiate LEVEL-2. The reported net loss for the quarter was $15.8 million, a substantial increase from the $4.0 million net loss in the third quarter of 2024. This burn rate is being funded by their cash position, which stood at $99.4 million as of September 30, 2025, a figure management believes supports operations through 2027.

Here's the quick math on the major expense categories for Q3 2025:

Expense Category	Q3 2025 Amount	Q3 2024 Amount
Research and Development (R&D) Expense	$10.3 million	$3.1 million
General and Administrative (G&A) Expense	$6.5 million	$1.5 million

The increase in R&D expenses, which rose by 232% year-over-year, is directly tied to advancing the clinical pipeline. You can see the breakdown of where that money is going, defintely.

• Costs driven by the ongoing Phase 3 LEVEL study execution.
• Start-up activities for the second global Phase 3 study, LEVEL-2, in anticipation of patient enrollment.
• Increased personnel costs due to an increased R&D employee headcount during 2025.

Stock-based compensation is a notable non-cash component inflating both R&D and G&A figures. The G&A costs, specifically, saw a massive jump to $6.5 million in Q3 2025 from $1.5 million in Q3 2024, largely due to this compensation.

The non-cash stock-based compensation expense breakdown for Q3 2025 is as follows:

• R&D Non-Cash Stock-Based Compensation: $1.1 million.
• G&A Non-Cash Stock-Based Compensation: $4.5 million.

The execution timeline for the clinical trials is a major cost driver. Tenax Therapeutics expects to complete enrollment of the 230 patients in the LEVEL study in the first half of 2026, with topline data expected in the second half of 2026. Furthermore, the company remains on track to initiate the global LEVEL-2 study within 2025, which involves qualifying over 160 investigative sites across 15 countries.

Finance: draft 13-week cash view by Friday.

Tenax Therapeutics, Inc. (TENX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Tenax Therapeutics, Inc. (TENX) as of late 2025. For a Phase 3 development-stage company, the current revenue picture is exactly what you'd expect: it's entirely dependent on capital markets, not product sales.

Currently, Tenax Therapeutics has zero product revenue. As a Phase 3, development-stage pharmaceutical company, the focus remains on clinical execution rather than commercial sales. The reported revenue for the third quarter ending September 30, 2025, was $0.0. This aligns with the company's status as it seeks approval for its lead candidate, TNX-103.

The primary source of operational funding right now is equity financing. This is how you keep the lights on and the trials running when you don't have a product on the market. Tenax Therapeutics successfully executed a significant capital raise to support this late-stage development.

Here's a look at the most recent financing event that underpins the current operations:

Financing Event	Date Closed	Gross Proceeds	Use of Proceeds
Private Placement Financing	March 5, 2025	Approximately $25 million	Advancing Phase 3 clinical trials (LEVEL and LEVEL-2) and general corporate expenses

This capital infusion helped bolster the balance sheet. As of September 30, 2025, Tenax Therapeutics reported cash and cash equivalents of $99.4 million. Management has stated that this cash position is expected to fund the Company through 2027. That runway is critical for reaching key data milestones without immediate pressure to raise again.

Future potential revenue streams are entirely contingent on the clinical success and subsequent regulatory approval of TNX-103, which is being evaluated for pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF).

The path to commercial revenue involves two main components:

• The potential for revenue from commercial sales of TNX-103 following any potential U.S. Food and Drug Administration (FDA) approval.
• The potential for future licensing or partnership revenue, specifically for ex-US commercialization efforts.

To be fair, Tenax Therapeutics significantly expanded its commercial potential in September 2025 by securing the exclusive worldwide development, commercialization, and manufacturing rights for orally-administered levosimendan. This move solidifies their control over the asset globally, which is key for structuring any future international deals that would generate partnership revenue.

Here's a quick look at the current financial standing relative to operations:

Metric	Value (as of late 2025)	Date Reference
Current Product Revenue	$0.00	Q3 2025
Cash & Equivalents	$99.4 million	September 30, 2025
Projected Cash Runway	Through 2027	Management Guidance

The entire revenue model for Tenax Therapeutics pivots on the data expected mid-2026 from the Phase 3 LEVEL study. Finance: review the cash burn rate against the $99.4 million balance by next Tuesday.