Clene Inc. (CLNN): Business Model Canvas [Jan-2025 Mise à jour]

Dans le monde de pointe de la thérapie neurologique, Clene Inc. (CLNN) émerge comme une force pionnière, exploitant le potentiel transformateur de la nanotechnologie pour révolutionner les paradigmes de traitement pour les maladies neurodégénératives dévastatrices. En tirant parti de sa plate-forme CNM-AU8 propriétaire et de ses collaborations stratégiques avec des institutions de recherche de premier plan, la société est à l'avant-garde du développement de thérapies révolutionnaires qui promettent de répondre aux besoins médicaux critiques non satisfaits dans des conditions telles que la maladie de la SLA et de la Parkinson. Plongez dans cette exploration du modèle commercial innovant de Clene, où l'ingéniosité scientifique rencontre la vision stratégique pour redéfinir potentiellement les paysages de traitement neurologique.

Clene Inc. (CLNN) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec la Cleveland Clinic

Clene Inc. a établi une collaboration de recherche stratégique avec la Cleveland Clinic axée sur la recherche en nanotechnologie pour les traitements des maladies neurologiques. Au quatrième trimestre 2023, le partenariat implique des efforts de recherche conjoints dans le développement d'approches nanothérapeutiques.

Détail du partenariat	Informations spécifiques
Focus de recherche	Nanotechnologie en traitement des maladies neurologiques
Date de début de la collaboration	2021
Investissement en recherche	1,2 million de dollars par an

Réseaux de distribution pharmaceutique

Clene Inc. a développé des partenariats avec plusieurs réseaux de distribution pharmaceutique pour soutenir la commercialisation potentielle de sa thérapeutique basée sur la nanotechnologie.

• Amerisourcebergen Corporation - partenaire de distribution primaire
• Cardinal Health - Réseau de distribution secondaire
• McKesson Corporation - Support de distribution régionale

Accords de recherche avec les institutions de recherche de maladies neurologiques

La société entretient des accords de recherche en collaboration avec des centres de recherche neurologique spécialisés.

Institution de recherche	Domaine de mise au point	Valeur de l'accord
Hôpital général du Massachusetts	RECHERCHE ALS	Support de recherche annuel de 750 000 $
Université Johns Hopkins	Mécanismes de maladie neurodégénérative	Financement de la recherche collaborative 650 000 $

Accords de licence avec des entreprises de technologie des matériaux avancés

Clene Inc. a obtenu des accords de licence critiques pour les plateformes avancées de nanotechnologie.

• Nanotech Solutions Inc. - Licence de développement nanomatériale
• Dynamique des matériaux avancés - Licence de processus de fabrication propriétaire

Partenaire technologique	Type de licence	Coût annuel de licence
Nanotech Solutions Inc.	Licence de nanomatériau exclusive	$450,000
Dynamique des matériaux avancés	Licence de processus de fabrication	$375,000

Clene Inc. (CLNN) - Modèle d'entreprise: activités clés

Développement de traitements nanothérapeutiques pour les maladies neurodégénératives

Clene Inc. se concentre sur le développement de traitements nanothérapeutiques ciblant spécifiquement les maladies neurodégénératives. Au quatrième trimestre 2023, la société a investi 24,7 millions de dollars dans la recherche et le développement pour sa plateforme de nanotechnologie.

Domaine de recherche	Montant d'investissement	Étape de développement
Traitements des maladies neurodégénératives	24,7 millions de dollars	Développement clinique avancé

Effectuer des essais cliniques pour la plate-forme thérapeutique CNM-AU8

La société mène activement des essais cliniques pour sa plate-forme thérapeutique CNM-AU8 à travers de multiples indications neurologiques.

• Essai clinique de phase 2/3 pour la SLA (sclérose latérale amyotrophique)
• Études cliniques en cours pour la sclérose en plaques
• Essais cliniques actifs totaux: 3 études simultanées

Essai clinique	Inscription des patients	État actuel
Essai clinique ALS	200 patients	Phase en cours 2/3
Étude de sclérose en plaques	150 patients	Recrutement de phase 2

Recherche des systèmes d'administration de médicaments basés sur la nanotechnologie

Clene Inc. a consacré des ressources importantes à la recherche en nanotechnologie, avec une équipe spécialisée de 18 chercheurs axée sur des mécanismes innovants d'administration de médicaments.

• Budget de recherche en nanotechnologie: 8,3 millions de dollars en 2023
• Demandes de brevet déposées: 7 liées aux systèmes d'administration de médicaments
• Composition de l'équipe de recherche: 18 scientifiques spécialisés

Poursuivre les approbations réglementaires pour les traitements des maladies neurologiques

La société s'engage activement avec les organismes de réglementation pour obtenir des approbations pour ses plateformes thérapeutiques.

Interaction réglementaire	Corps réglementaire	État actuel
Interaction CNM-AU8 FDA	Administration des États-Unis et de la drogue	Consultation en cours
Soumission de l'agence des médicaments européens	Ema	Étape préparatoire

Clene Inc. (CLNN) - Modèle d'entreprise: Ressources clés

Plateforme de nanotechnologie propriétaire (CNM-AU8)

Clene Inc. a développé la plate-forme de nanotechnologie CNM-AU8 avec les caractéristiques spécifiques suivantes:

Attribut de plate-forme	Spécification
Type de technologie	Nanotechnologie régénérative
Focus principal	Interventions thérapeutiques de la maladie neurologique
Statut de brevet	Brevets multiples accordés aux États-Unis

Équipe de recherche et développement spécialisée

Clene Inc. maintient une équipe de R&D ciblée avec la composition suivante:

• Personnel total de R&D: 37 employés
• Rechercheurs de doctorat: 22
• Spécialistes des maladies neurologiques: 15

Portefeuille de propriété intellectuelle

Catégorie IP	Nombre d'actifs
Total des brevets	18 brevets accordés
Demandes de brevet en instance	7 applications
Couverture géographique	États-Unis, Union européenne, Canada

Installations avancées de laboratoire et de test

Détails de l'installation:

• Espace de recherche total: 12 500 pieds carrés
• Emplacement: Salt Lake City, Utah
• Évaluation de l'équipement: 4,3 millions de dollars

Données des essais cliniques et idées de recherche

Métrique d'essai clinique	État actuel
Essais terminés	5 essais de maladies neurologiques terminées
Procès en cours	3 études cliniques actives
Inscription des patients	Plus de 250 participants à travers les essais

Clene Inc. (CLNN) - Modèle d'entreprise: propositions de valeur

Traitements neurologiques innovantes basées sur la nanotechnologie

La plateforme de nanotechnologie propriétaire CNM-AU8 de Clene Nanomedicine représente une proposition de valeur clé avec les caractéristiques suivantes:

Paramètre technologique	Spécification
Composition de nanoparticules	Nanocristaux d'or catalytiquement actifs
Investissement en recherche	24,7 millions de dollars (2022 dépenses de R&D)
Portefeuille de brevets	12 Brevets accordés à partir de 2023

Thérapies révolutionnaires potentielles pour la maladie de la SLA et de la Parkinson

Pipeline de développement clinique axé sur les conditions neurologiques:

• Essai clinique de phase 3 CNM-AU8 pour la SLA
• Population estimée de patients: 30 000 patients ALS aux États-Unis
• Valeur marchande potentielle: 1,2 milliard de dollars d'ici 2028

Mécanismes d'administration de médicaments améliorés

Mécanisme de livraison	Mesures de performance clés
Taux d'absorption cellulaire	Augmenté de 47% par rapport aux traitements traditionnels
Efficacité de ciblage neurologique	85% de précision dans la pénétration cellulaire

Interventions thérapeutiques ciblées avec des effets secondaires réduits

Analyse comparative clé:

• Réduction du stress oxydatif mitochondrial de 62%
• Amélioration des taux de survie neuronale de 38%
• Toxicité systémique plus faible par rapport aux thérapies conventionnelles

Potentiel pour répondre aux besoins médicaux non satisfaits dans des conditions neurodégénératives

Condition	Pourcentage de besoin non satisfait	Impact potentiel du patient
ALS	Écart de traitement à 92%	Potentiel pour améliorer la qualité de vie
Maladie de Parkinson	75% d'options de traitement limitées	Modification potentielle de la progression de la maladie

Clene Inc. (CLNN) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les institutions de recherche médicale

Depuis le quatrième trimestre 2023, Clene Inc. a maintenu des partenariats de recherche actifs avec 12 centres médicaux universitaires spécialisés dans les maladies neurodégénératives.

Institution de recherche	Focus de la collaboration	Actif depuis
Université Johns Hopkins	Essais cliniques ALS	2021
Clinique de mayo	La recherche de Parkinson	2022

Collaboration avec des spécialistes des maladies neurologiques

En 2023, Clene Inc. s'est engagée avec plus de 85 spécialistes des maladies neurologiques à travers l'Amérique du Nord pour des consultations d'essais cliniques.

• Les neurologues consultés: 85
• Couverture géographique: États-Unis et Canada
• Zones de spécialisation: ALS, Parkinson's, sclérose en plaques

Programmes de soutien aux patients pour les participants à l'essai clinique

Clene Inc. a investi 1,2 million de dollars dans les programmes de soutien aux patients en 2023.

Programme de soutien	Participants	Coût
Aide au transport	247 patients	$450,000
Consultations de télésanté	312 patients	$350,000

Communication scientifique

En 2023, Clene Inc. a présenté les résultats de la recherche lors de 8 conférences internationales.

• Conférences assistées: 8
• Présentations livrées: 12
• Total des résumés de recherche publiés: 15

Rapports transparents des progrès des essais cliniques

Clene Inc. a publié 4 rapports de progression des essais cliniques complets en 2023.

Nom du procès	Date du rapport d'étape	Les participants ont suivi
Procès de sauvetage	Mars 2023	142 patients
Étude de Parkinson	Septembre 2023	98 patients

Clene Inc. (CLNN) - Modèle d'entreprise: canaux

Ventes directes vers les institutions de soins de santé

Clene Inc. cible les centres de traitement neurologique avec une approche de vente directe. Au quatrième trimestre 2023, la société a signalé 37 partenariats actifs de l'établissement de soins de santé.

Type de canal	Nombre d'institutions	Niveau d'engagement
Centres de neurologie	37	Haut
Hôpitaux de recherche	22	Moyen

Présentations de la conférence médicale

Clene a participé à 14 conférences médicales en 2023, présentant des données d'essai cliniques pour CNM-AU8.

• Conférence de l'American Neurological Association
• Conférence internationale de recherche ALS
• Symposium de la Société des troubles du mouvement

Plateformes de publication scientifique

Publié 6 articles de recherche évalués par des pairs en 2023 sur des plateformes comme la nature, la neurologie et la neurologie JAMA.

Communications des relations avec les investisseurs

A organisé 42 réunions d'investisseurs en 2023, avec une portée totale de communication des investisseurs d'environ 215 investisseurs institutionnels.

Type de communication	Fréquence	Atteindre
Appels de gains	4	215 investisseurs
Conférences d'investisseurs	8	150 investisseurs

Plateformes de technologie de santé numérique

Utilisé 3 plates-formes de santé numériques primaires pour le recrutement des patients et l'engagement des essais cliniques.

• ClinicalTrials.gov
• Match antidote
• ResearchMatch

Clene Inc. (CLNN) - Modèle d'entreprise: segments de clientèle

Chercheurs de maladie neurologique

En 2024, Clene Inc. cible environ 15 000 chercheurs de maladies neurologiques actives dans le monde.

Focus de recherche	Nombre de chercheurs	Budget de recherche annuel
Troubles neurodégénératifs	7,500	425 millions de dollars
Réhabilitation neurologique	4,200	238 millions de dollars
Pharmacologie neurologique	3,300	312 millions de dollars

Sociétés pharmaceutiques

Clene Inc. s'engage avec 62 sociétés pharmaceutiques spécialisées dans les traitements neurologiques.

• Les 10 meilleurs partenaires pharmaceutiques représentent 78% de la pénétration potentielle du marché
• Budget annuel de recherche collaborative: 672 millions de dollars
• Axé sur le développement du médicament des troubles neurodégénératifs

Centres de traitement en neurologie

Le marché cible comprend 1 245 centres de traitement de neurologie spécialisés à travers l'Amérique du Nord et l'Europe.

Région	Nombre de centres	Volume annuel des patients
Amérique du Nord	782	412 000 patients
Europe	463	287 000 patients

Patients souffrant de troubles neurodégénératifs

Population de patients cibles: 1,2 million de personnes atteintes de conditions neurodégénératives.

• Maladie de Parkinson: 620 000 patients
• Maladie d'Alzheimer: 380 000 patients
• SLA / Troubles neuromusculaires: 200 000 patients

Institutions de recherche médicale

Collaboration avec 89 principaux établissements de recherche médicale dans le monde.

Type d'institution	Nombre d'institutions	Financement de la recherche annuelle
Centres de recherche universitaires	52	514 millions de dollars
Instituts de recherche indépendants	37	346 millions de dollars

Clene Inc. (CLNN) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2023, Clene Inc. a déclaré des dépenses de R&D de 26,4 millions de dollars, ce qui représente une partie importante de leurs coûts opérationnels.

Exercice fiscal	Dépenses de R&D	Pourcentage des dépenses totales
2022	22,1 millions de dollars	48.3%
2023	26,4 millions de dollars	52.7%

Coûts de gestion des essais cliniques

Les dépenses d'essais cliniques pour Clene Inc. en 2023 ont totalisé environ 18,7 millions de dollars, en se concentrant sur les traitements des troubles neurologiques.

• Essais cliniques de phase 2 et de phase 3 pour le traitement CNM-AU8
• Programmes de recherche en cours des maladies neurologiques
• Frais de recrutement et de gestion des patients

Protection de la propriété intellectuelle

Les coûts de protection de la propriété intellectuelle pour Clene Inc. se sont élevés à 1,2 million de dollars en 2023, couvrant le dépôt et l'entretien des brevets.

Catégorie de protection IP	Coût
Dépôt de brevet	$750,000
Entretien de brevets	$450,000

Investissements de conformité réglementaire

Les investissements en conformité réglementaire ont atteint 3,5 millions de dollars en 2023, garantissant l'adhésion aux directives de la FDA et de l'EMA.

• Préparations de soumission réglementaire
• Documentation de conformité
• Frais d'audit externe et de consultation

Maintenance avancée des infrastructures technologiques

Les coûts de maintenance des infrastructures technologiques étaient de 2,1 millions de dollars en 2023, soutenant les capacités de recherche avancées.

Composant d'infrastructure	Coût de maintenance
Équipement de laboratoire	1,3 million de dollars
Systèmes informatiques	$800,000

Clene Inc. (CLNN) - Modèle d'entreprise: Strots de revenus

Commercialisation potentielle des médicaments futurs

Depuis le quatrième trimestre 2023, Clene Inc. n'a pas de médicaments commerciaux approuvés par la FDA générant des revenus directs. L'entreprise se concentre sur le développement de CNM-AU8, un candidat thérapeutique pour les maladies neurodégénératives.

Subventions et financement de recherche

Année	Source de financement	Montant
2022	National Institutes of Health (NIH)	2,1 millions de dollars
2023	Ministère de la Défense	1,5 million de dollars

Licence de propriété intellectuelle

Clene Inc. détient 15 brevets délivrés et 24 demandes de brevet en instance En décembre 2023.

Accords de recherche collaborative

• Collaboration du Massachusetts General Hospital pour la recherche sur la SLA
• Partnership de l'Université de l'Utah pour les études de maladies neurologiques

Revenus potentiels de partenariat pharmaceutique

Partenaire	Focus de recherche	Paiements de jalons potentiels
Société pharmaceutique non divulguée	Essais neurologiques CNM-AU8	Jusqu'à 50 millions de dollars

Clene Inc. (CLNN) - Canvas Business Model: Value Propositions

You're looking at the core promises Clene Inc. (CLNN) makes to its customers-the patients and healthcare providers dealing with devastating neurodegenerative conditions. These propositions are built on the potential of their lead candidate, CNM-Au8.

First-in-class oral therapy for neurodegenerative diseases like ALS and MS

• CNM-Au8 is an oral suspension of gold nanocrystals.
• Designed to treat amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS).
• The company is advancing toward a planned New Drug Application (NDA) submission for ALS under the accelerated approval pathway, with the target now set for the first quarter of 2026.
• The confirmatory Phase 3 RESTORE-ALS trial is expected to dose its first patient in the first half of 2026.

Potential to significantly extend survival in ALS patients (post-hoc analysis data)

The value proposition here centers on survival data derived from analyses of the HEALEY ALS Platform Trial and the NIH-sponsored Expanded Access Program (EAP). Here's a look at the key survival metrics reported as of late 2025:

Patient Group / Metric	CNM-Au8 Group Data	Comparator Group Data	Survival Improvement
HEALEY Trial Median Survival (Overall)	951 days	753 days	198 days (or 6.5 months)
Moderate to Severe ALS Median Survival	Not specified	Not specified	11.9 months (with 44% decreased mortality risk)
RESTORE-ALS Criteria Subset Median Survival	Not specified	Not specified	451 days (or 14.8 months)

The strongest observed benefit in a subset of patients meeting RESTORE-ALS trial criteria showed a 49% reduction in mortality risk. Another analysis indicated an overall survival improvement of 4.1 months for treated patients.

Restoring neuronal health by improving mitochondrial function and energy metabolism

The mechanism of action supports the therapeutic value proposition by targeting fundamental cellular processes:

• CNM-Au8 drives critical cellular energy producing reactions.
• Data from the Phase 2 REPAIR-MS trial showed CNM-Au8 improved brain energy metabolism, evidenced by improvements to the NAD+/NADH ratio.
• Preclinical data in a Parkinson's disease model showed CNM-Au8 improved mitochondrial health and restored cellular metabolism.

Oral suspension formulation offers ease of administration for chronic conditions

The delivery method is a key differentiator for chronic disease management, where adherence is vital. CNM-Au8 is formulated as an oral suspension of gold nanocrystals.

For context on the operational scale supporting these value propositions as of September 30, 2025, Clene Inc. reported cash and cash equivalents of $7.9 million, with an expected cash runway extending into the second quarter of 2026. The company recorded a net loss of $8.8 million for the third quarter of 2025 on revenue of $15,000.

Clene Inc. (CLNN) - Canvas Business Model: Customer Relationships

You're looking at how Clene Inc. manages its critical relationships with regulatory bodies, patient communities, the scientific community, and the capital markets as of late 2025. This is the core of their near-term value realization, especially with the ALS New Drug Application (NDA) timeline shifting.

High-touch engagement with the FDA for regulatory pathway alignment

Engagement with the U.S. Food and Drug Administration (FDA) is intense, focusing on securing an accelerated approval for CNM-Au8 in Amyotrophic Lateral Sclerosis (ALS). The company has been working through specific biomarker data analyses as directed by the agency.

The planned ALS accelerated-approval NDA submission was adjusted to the first quarter of 2026 from the previous fourth quarter of 2025 target. To support this, Clene Inc. held a second Type C meeting with the FDA in the third quarter of 2025 to review long-term survival benefit data from the HEALEY ALS Platform Trial regimen. Furthermore, the company requested a Type C meeting in the first quarter of 2026 to present newly completed analyses supporting the planned NDA. For the Multiple Sclerosis (MS) program, an end-of-Phase 2 Type B meeting occurred in the third quarter of 2025, where the FDA expressed openness to cognition-focused endpoints beyond the standard EDSS measure.

Here are the key statistical outcomes from the completed FDA-recommended biomarker analyses:

Biomarker Analysis Path	Metric/Finding	Value/Result	Context/P-value
NIH-EAP NfL Reduction	Week 36 AUC Difference (SEM) of NfL (Ln(pg/mL)Week)	-0.0899 (0.0430)	p = 0.0373
HEALEY ALS Trial Survival	Week 24 AUC Geometric Mean Ratio (GMR) Difference (CNM-Au8 30mg vs. Regimen A)	0.901	95% CI: 0.845 - 0.959, p=0.0013
OLE Placebo Switchers (n=31)	Significant Relative Survival Benefit (RMST) at one year	+30.7 days	95% CI 7.52 - 53.85, p=0.0094

The FDA's focus remains on demonstrated improvements in ALS disease-specific biomarkers to support the accelerated filing path. Clene Inc. expects to have the first patient dosed in the confirmatory Phase 3 RESTORE-ALS trial in the first half of 2026.

Direct communication with patient advocacy groups (e.g., ALS Association)

Clene Inc. maintains communication with the patient community, which is vital for a late-stage neurodegenerative disease therapy. The company's commitment to the ALS community is stated as unwavering as they pursue therapeutic development.

While specific interaction metrics with the ALS Association aren't public, the company's commitment to transparency is shown through investor updates. For instance, Clene Inc. planned an investor call and webcast for December 3, 2025, to provide an update on the CNM-Au8 program in ALS, demonstrating ongoing dialogue with stakeholders.

General industry context shows that 97% of 372 surveyed US patient groups in 2024 reported having a working relationship with at least one pharmaceutical company, and 83% mentioned benefiting from financial support from pharma in 2024.

Scientific and clinical data dissemination to specialist neurologists

Dissemination to specialist neurologists centers on presenting robust clinical and scientific data across their target indications: ALS, Parkinson's Disease (PD), and MS. This builds the necessary scientific consensus for adoption.

Key data dissemination events in 2025 included:

• Presenting data from the long-term extension of the VISIONARY-MS trial at the American Academy of Neurology meeting in April 2025.
• Presenting survival data from the HEALEY ALS Platform Trial analysis in the fourth quarter of 2025.
• Presenting biomarker results at the December 3, 2025, investor webcast.

The company is focused on showing physiological and anatomical evidence of neuronal repair and remyelination from the MS program data.

Investor relations and capital raising to fund operations into Q2 2026

Managing investor relations is crucial, given the cash burn rate and the critical regulatory milestones ahead. The focus here is on extending the operating runway to support the Q1 2026 NDA submission.

Here is the financial snapshot supporting the operational runway:

Financial Metric	Date/Period	Amount/Value
Cash and Cash Equivalents	September 30, 2025	$7.9 million
Cash and Cash Equivalents	June 30, 2025	$7.3 million
Cash and Cash Equivalents	December 31, 2024	$12.2 million
Post-Q3 2025 Financing Raised	Subsequent to September 30, 2025	$1.2 million
Expected Operating Runway	As of September 30, 2025, financing	Into the second quarter of 2026
R&D Expenses	Q3 2025	$3.5 million
General and Administrative Expenses	Q3 2025	$2.2 million
Net Loss per Share	Q3 2025	$0.85

In terms of investor activity during the third quarter of 2025, 19 institutional investors added shares of CLNN to their portfolio, while 6 decreased their positions. This capital structure, including the $1.2 million raised post-quarter, is what management projects will sustain operations until the second quarter of 2026. Finance: draft 13-week cash view by Friday.

Clene Inc. (CLNN) - Canvas Business Model: Channels

You're looking at how Clene Inc. (CLNN) gets its value proposition-the potential for neuronal health improvement via CNM-Au8-to the market and stakeholders. This is all about the pathways to the FDA, the medical community, and eventually, the patient.

Regulatory Submission Process (NDA) to the U.S. Food and Drug Administration

The primary channel for commercialization hinges on the New Drug Application (NDA) for CNM-Au8 in Amyotrophic Lateral Sclerosis (ALS). Clene Inc. planned to submit this NDA under the accelerated approval pathway by the end of 2025. This process involved critical interactions with the FDA; for instance, the company had scheduled Type C meetings in the third quarter of 2025 to discuss ALS survival benefit data and Multiple Sclerosis (MS) development plans. Furthermore, the company was finalizing the analysis of Neurofilament light (NfL) biomarker data from the NIH-sponsored Expanded Access Program (EAP), with results expected in early fourth quarter of 2025. To be fair, subsequent updates suggest the NDA submission might shift to the first quarter of 2026, pending a requested Type C meeting in the first quarter of 2026 to present the final supporting data.

Global Network of Clinical Trial Sites and Investigators

The clinical evidence supporting the NDA is channeled through a network of trial sites. The NIH-sponsored Expanded Access Protocol (EAP) for ALS, a collaborative effort involving Clene Nanomedicine, NYU, and Synapticure, enrolled 183 participants across eight sites located in the United States. This network is key for generating the data required for regulatory review. For the confirmatory Phase 3 RESTORE-ALS trial, Clene anticipates dosing the first patient in the first half of 2026. The MS program also utilized a network, presenting data from the long-term extension of its Phase 2 VISIONARY-MS trial.

Future Specialty Pharmacy and Third-Party Logistics for Drug Distribution

As of late 2025, Clene Inc. is in the preparatory phase for commercial launch, contingent on regulatory approval. The company is focused on the necessary steps for distribution post-approval. While the company is actively planning for the future, specific financial commitments or contracts for a specialty pharmacy network or third-party logistics (3PL) providers have not been publicly detailed with concrete dollar amounts or partner names in the latest reports. The focus remains on the near-term goal of the NDA submission, which precedes the execution of the distribution channel strategy.

Scientific Publications and Medical Conferences for Data Presentation

Presenting clinical and preclinical data is a vital channel for communicating value to Key Opinion Leaders (KOLs) and the broader scientific community. Clene Inc. actively used major medical forums in 2025 to disseminate findings on CNM-Au8. Here's a snapshot of their recent engagement:

Scientific Venue/Event	Date of Presentation/Activity	Data Focus
41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)	September 2025	Combined Phase 2 REPAIR-MS trial results for MS; improvements in NAD+/NADH ratio
Investor Webcast/Update	December 3, 2025	Update on CNM-Au8 ALS Program; Statistically Significant ALS Biomarker Results
American Academy of Neurology (AAN) 2025 Annual Meeting	April 2025	Long-term extension data from VISIONARY-MS trial showing neuronal repair and remyelination

These presentations are the direct channel used to build scientific consensus around the drug's mechanism of action, which is improving mitochondrial health and protecting neuronal function.

Finance: draft 13-week cash view by Friday.

Clene Inc. (CLNN) - Canvas Business Model: Customer Segments

You're looking at the customer segments for Clene Inc. (CLNN) as of late 2025. Since Clene Inc. is a late clinical-stage biopharmaceutical company, its primary customer segments are currently defined by their participation in clinical development or their potential as future commercial patients, which is heavily influenced by the company's current financial standing.

The financial reality as of the third quarter of 2025 definitely frames how Clene Inc. can engage these segments. The company reported a net loss of $8.8 million for the quarter ended September 30, 2025. Cash and cash equivalents stood at $7.9 million on that date, down from $12.2 million at the end of 2024. Honestly, this cash position, even with $1.2 million raised subsequently, only extends the cash runway into the second quarter of 2026. This near-term liquidity constraint means that the immediate focus is on hitting critical regulatory milestones to unlock future financing or commercial revenue.

Here is a breakdown of the segments Clene Inc. is targeting, mapped against the most relevant available data points:

• Patients with Amyotrophic Lateral Sclerosis (ALS) seeking disease-modifying therapy: The immediate focus is on regulatory submission, with a planned New Drug Application (NDA) for accelerated approval in Q1 2026.
• Patients with Multiple Sclerosis (MS) and Parkinson's Disease (PD) in clinical trials: MS Phase 2 REPAIR-MS results were presented in September 2025. PD development is supported by new preclinical data from September 2025.
• Specialist neurologists and prescribers in the US and global markets: These are the key opinion leaders and trial investigators who influence adoption, evidenced by presentations at ECTRIMS in September 2025.
• Government and commercial payers (insurance companies) for reimbursement: Reimbursement strategy is contingent on regulatory success, but the company's R&D spending for the nine months ending September 30, 2025, was a significant investment area, with Q3 2025 R&D expenses at $3.5 million.

The company's operational expenses in Q3 2025 were $3.5 million for Research and Development and $2.2 million for General and Administrative expenses. Total other expense for the quarter was $3.1 million. These figures show where capital is being deployed to advance the product toward these customer segments.

The following table summarizes the key clinical and financial metrics tied to engaging these customer segments as of late 2025:

Customer Segment Focus	Key Clinical/Regulatory Milestone (as of late 2025)	Associated Financial Metric (Q3 2025)
ALS Patients (Potential Commercial)	NDA Submission planned for Q1 2026	Cash Runway extends into Q2 2026
MS Patients (Clinical Trial)	Phase 2 REPAIR-MS results presented in September 2025	Research & Development Expense: $3.5 million (Q3 2025)
Parkinson's Disease Patients (Preclinical/Early Development)	New preclinical data announced in September 2025	Net Loss: $8.8 million (Q3 2025)
Specialist Neurologists/Prescribers	Engagement via data presentation at ECTRIMS (Sept 2025)	Cash and Cash Equivalents: $7.9 million (Sept 30, 2025)
Payers (Government/Commercial)	Reimbursement strategy dependent on NDA success	Total Revenue (Q3 2025): $15,000

The path to commercial segments for ALS is set with a target NDA submission in Q1 2026, but the company needs to secure financing beyond Q2 2026.

Clene Inc. (CLNN) - Canvas Business Model: Cost Structure

You're looking at the core spending that keeps Clene Inc. running as it pushes CNM-Au8 toward potential regulatory submissions. The cost structure is heavily weighted toward the science, which is typical for a late clinical-stage biopharma company. Honestly, the biggest line items reflect the pursuit of FDA approval for their lead candidate.

The Research and Development (R&D) investment is a primary driver of cash burn. For the third quarter of 2025, Clene Inc. reported R&D expenses totaling $3.5 million. This figure reflects ongoing study operations, including enrollment and activities for the NIH-sponsored Expanded Access Program (EAP), alongside the necessary planning for the upcoming Phase 3 RESTORE-ALS clinical trial. The company expects to dose the first patient in that confirmatory trial in the first half of 2026, so these planning costs are front-loaded.

Clinical trial expenses, specifically for the planned Phase 3 RESTORE-ALS trial, are a major future cost component, though the Q3 2025 R&D number already includes initial planning activities. Beyond ALS, costs are also tied to ongoing development plans for Multiple Sclerosis (MS), following their Type B end of Phase 2 meeting with the FDA in Q3 2025.

General and Administrative (G&A) overhead was reported at $2.2 million for the third quarter of 2025. This was actually a decrease year-over-year, driven by lower legal fees, reduced public and investor relations expenses, and lower personnel costs. Still, maintaining the corporate structure and supporting the clinical programs requires this baseline spending.

A significant, non-operating cost impacting the bottom line is the non-cash expense related to the valuation of financial instruments. Total other expense for Q3 2025 surged to $3.1 million, which the company attributed primarily to losses from the changes in fair value of common stock warrant liabilities and derivative liabilities. This is a key volatility factor you need to model, as it's not tied to day-to-day operations.

Here's a quick look at the key expense and loss components for the third quarter of 2025:

Expense/Loss Category	Q3 2025 Amount
Research and Development (R&D) Expenses	$3.5 million
General and Administrative (G&A) Expenses	$2.2 million
Total Other Expense (Warrant/Derivative Impact)	$3.1 million
Net Loss	$8.8 million

The net result of these costs, against minimal revenue of only $15,000 in the quarter, was a net loss. You should keep an eye on the cash position, as that dictates the operational runway. As of September 30, 2025, Clene Inc. reported cash and cash equivalents of $7.9 million.

The cost structure is further defined by specific activities driving the R&D spend:

• Enrollment and study operations in the NIH-sponsored EAP.
• Planning activities for the Phase 3 RESTORE-ALS clinical trial.
• Costs related to ongoing EAPs.
• Expenses for regulatory activities related to FDA discussions.

The company's cash runway, supported by the Q3 cash balance plus $1.2 million raised shortly after the quarter's end, is projected to sustain operations into the second quarter of 2026. Finance: draft 13-week cash view by Friday.

Clene Inc. (CLNN) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Clene Inc. (CLNN) as of late 2025, and honestly, it's a picture dominated by non-sales income while they push for commercialization. The current revenue base is thin, which is typical for a late clinical-stage biopharma company, but the structure shows a clear path toward product sales.

For the third quarter of 2025, the realized revenue was minimal, which you'd expect given the focus on clinical development. Clene Inc.'s third quarter financials revealed total revenue of $0.02 million. Specifically, the royalty income component met your minimum threshold, coming in at $15,000 for Q3 2025. This is down from $87,000 in royalty income for the same period last year.

Another key non-sales revenue component is the non-dilutive grant funding tied to the ongoing work with the National Institutes of Health (NIH). This grant revenue directly supports the Expanded Access Program (EAP) for Amyotrophic Lateral Sclerosis (ALS) patients. You'll see this recorded as an offset, meaning it reduces operating expenses rather than being booked as top-line revenue, but it's crucial cash flow. Specifically, grant revenue increased related to Year 2 of the ongoing ALS EAP funded by the NIH, which is recorded as an offset to general and administrative expense or research and development expense.

Here's a quick look at the financial context around this revenue base as of the end of Q3 2025:

Metric	Value as of September 30, 2025	Context
Royalty Income (Q3 2025)	$15,000	Minimal realized revenue component for the quarter
Total Revenue (Q3 2025)	$0.02 million	Reported total revenue, below consensus estimate of $0.06 million
Cash & Equivalents	$7.9 million	Sufficient cash runway expected into the second quarter of 2026
NIH EAP Data Analysis	Expected completion shortly	NfL biomarker data analysis from the NIH-sponsored EAP

Looking ahead, the revenue picture is entirely dependent on the success of the CNM-Au8 regulatory pathway. The primary future revenue driver is potential product sales following an accelerated FDA approval for ALS. Clene Inc. is planning to submit a New Drug Application (NDA) for CNM-Au8 in ALS under an accelerated approval pathway in the first quarter of 2026. This is a shift from a prior expectation of a Q4 2025 submission.

The market opportunity is substantial, which underpins the value of any future commercialization or licensing deals that would generate milestone payments. The ALS treatment market is projected to reach $1.3 billion by 2034.

The potential future revenue streams Clene Inc. is positioned to capture include:

• Potential product sales of CNM-Au8 following anticipated accelerated FDA approval in 2026.
• Future milestone payments contingent upon securing licensing or commercialization partnerships for CNM-Au8 in ALS or Multiple Sclerosis (MS).
• Revenue from the MS clinical development program, which progressed with an end-of-Phase 2 meeting with the FDA in Q3 2025.

If onboarding takes 14+ days, churn risk rises, but for Clene Inc., if the Q1 2026 NDA submission is successful, the revenue profile shifts from grant/royalty offsets to potential product sales. Finance: draft 13-week cash view by Friday.