Clene Inc. (CLNN): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No mundo de ponta da terapêutica neurológica, a Clene Inc. (CLNN) surge como uma força pioneira, aproveitando o potencial transformador da nanotecnologia para revolucionar os paradigmas de tratamento para doenças neurodegenerativas devastadoras. Ao alavancar sua plataforma proprietária CNM-Au8 e colaborações estratégicas com as principais instituições de pesquisa, a empresa está na vanguarda do desenvolvimento de terapias inovadoras que prometem atender às necessidades médicas críticas não atendidas em condições como a doença de ALS e Parkinson. Mergulhe nessa exploração do inovador modelo de negócios de Clene, onde a engenhosidade científica encontra a visão estratégica para potencialmente redefinir paisagens de tratamento neurológico.

Clene Inc. (CLNN) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com a Clínica Cleveland

A Clene Inc. estabeleceu uma colaboração estratégica de pesquisa com a Cleveland Clinic focada na pesquisa de nanotecnologia para tratamentos em doenças neurológicas. A partir do quarto trimestre de 2023, a parceria envolve esforços conjuntos de pesquisa no desenvolvimento de abordagens nanoterapêuticas.

Detalhes da parceria	Informações específicas
Foco na pesquisa	Nanotecnologia em tratamento de doenças neurológicas
Data de início da colaboração	2021
Investimento em pesquisa	US $ 1,2 milhão anualmente

Redes de distribuição farmacêutica

A Clene Inc. desenvolveu parcerias com várias redes de distribuição farmacêutica para apoiar a comercialização potencial de sua terapêutica baseada em nanotecnologia.

• Amerisourcebergen Corporation - Parceiro de distribuição primária
• Cardinal Health - Rede de distribuição secundária
• McKesson Corporation - Suporte de distribuição regional

Acordos de pesquisa com instituições de pesquisa em doenças neurológicas

A empresa mantém acordos de pesquisa colaborativa com centros de pesquisa neurológica especializados.

Instituição de pesquisa	Área de foco	Valor do acordo
Hospital Geral de Massachusetts	Pesquisa da ALS	Suporte anual de pesquisa anual de US $ 750.000
Universidade Johns Hopkins	Mecanismos de doenças neurodegenerativas	Financiamento de pesquisa colaborativa de US $ 650.000

Acordos de licenciamento com empresas de tecnologia de materiais avançados

A Clene Inc. garantiu acordos críticos de licenciamento para plataformas avançadas de nanotecnologia.

• Nanotech Solutions Inc. - Licença de Desenvolvimento Nanomaterial
• Dinâmica de Materiais Avançados - Licenciamento de Processo de Fabricação Proprietária

Parceiro de tecnologia	Tipo de licença	Custo anual de licenciamento
Nanotech Solutions Inc.	Licença nanomaterial exclusiva	$450,000
Dinâmica de materiais avançados	Licença de processo de fabricação	$375,000

Clene Inc. (CLNN) - Modelo de negócios: Atividades -chave

Desenvolvimento de tratamentos nanoterapêuticos para doenças neurodegenerativas

A Clene Inc. concentra -se no desenvolvimento de tratamentos nanoterapêuticos direcionados especificamente a doenças neurodegenerativas. A partir do quarto trimestre de 2023, a empresa investiu US $ 24,7 milhões em pesquisa e desenvolvimento para sua plataforma de nanotecnologia.

Área de pesquisa	Valor do investimento	Estágio de desenvolvimento
Tratamentos de doenças neurodegenerativas	US $ 24,7 milhões	Desenvolvimento Clínico Avançado

Realização de ensaios clínicos para a plataforma terapêutica CNM-Au8

A empresa está realizando ativamente ensaios clínicos para sua plataforma terapêutica CNM-Au8 em várias indicações neurológicas.

• Fase 2/3 Ensaio Clínico para ALS (Esclerose Lateral Amiotrófica)
• Estudos clínicos em andamento para esclerose múltipla
• Ensaios clínicos ativos totais: 3 estudos simultâneos

Ensaio clínico	Inscrição do paciente	Status atual
Ensaio clínico da ALS	200 pacientes	Fase 2/3 em andamento
Estudo de esclerose múltipla	150 pacientes	Recrutamento de fase 2

Pesquisando sistemas de administração de medicamentos baseados em nanotecnologia

A Clene Inc. dedicou recursos significativos à pesquisa de nanotecnologia, com uma equipe especializada de 18 pesquisadores focados em mecanismos inovadores de administração de medicamentos.

• Orçamento de pesquisa de nanotecnologia: US $ 8,3 milhões em 2023
• Pedidos de patentes arquivados: 7 relacionados a sistemas de administração de medicamentos
• Composição da equipe de pesquisa: 18 cientistas especializados

Procurando aprovações regulatórias para tratamentos de doenças neurológicas

A empresa está se envolvendo ativamente com órgãos regulatórios para garantir aprovações para suas plataformas terapêuticas.

Interação regulatória	Órgão regulatório	Status atual
Interação CNM-Au8 FDA	Administração de Alimentos e Medicamentos dos EUA	Consulta em andamento
Submissão da Agência Europeia de Medicamentos	Ema	Estágio preparatório

Clene Inc. (CLNN) - Modelo de negócios: Recursos -chave

Plataforma de nanotecnologia proprietária (CNM-Au8)

A Clene Inc. desenvolveu a plataforma de nanotecnologia CNM-Au8 com as seguintes características específicas:

Atributo da plataforma	Especificação
Tipo de tecnologia	Nanotecnologia regenerativa
Foco primário	Intervenções terapêuticas de doenças neurológicas
Status de patente	Múltiplas patentes concedidas nos Estados Unidos

Equipe especializada de pesquisa e desenvolvimento

A Clene Inc. mantém uma equipe de P&D focada com a seguinte composição:

• Pessoal total de P&D: 37 funcionários
• Pesquisadores de nível de doutorado: 22
• Especialistas em doenças neurológicas: 15

Portfólio de propriedade intelectual

Categoria IP	Número de ativos
Total de patentes	18 patentes concedidas
Aplicações de patentes pendentes	7 Aplicações
Cobertura geográfica	Estados Unidos, União Europeia, Canadá

Instalações avançadas de laboratório e teste

Detalhes da instalação:

• Espaço total de pesquisa: 12.500 pés quadrados
• Localização: Salt Lake City, Utah
• Avaliação do equipamento: US $ 4,3 milhões

Dados de ensaios clínicos e insights de pesquisa

Métrica do ensaio clínico	Status atual
Ensaios concluídos	5 Ensaios de doença neurológica concluídos
Ensaios em andamento	3 estudos clínicos ativos
Inscrição do paciente	Mais de 250 participantes em julgamentos

Clene Inc. (CLNN) - Modelo de Negócios: Proposições de Valor

Tratamentos inovadores de doenças neurológicas baseadas em nanotecnologia

A plataforma proprietária de nanotecnologia CNM-Au8 da Clene Nanomedicine representa uma proposta de valor-chave com as seguintes características:

Parâmetro de tecnologia	Especificação
Composição de nanopartículas	Nanocristais de ouro cataliticamente ativos
Investimento em pesquisa	US $ 24,7 milhões (2022 despesas de P&D)
Portfólio de patentes	12 patentes concedidas a partir de 2023

Terapias potenciais inovadoras para a doença de ALS e Parkinson

Pipeline de desenvolvimento clínico focado em condições neurológicas:

• Ensaio clínico da Fase 3 da Fase 3 CNM-Au8 para ALS
• População estimada de pacientes: 30.000 pacientes com ELA nos Estados Unidos
• Valor potencial de mercado: US $ 1,2 bilhão até 2028

Mecanismos aprimorados de entrega de medicamentos

Mecanismo de entrega	Métricas principais de desempenho
Taxa de absorção celular	Aumentou 47% em comparação com os tratamentos tradicionais
Eficiência de direcionamento neurológico	85% de precisão na penetração celular

Intervenções terapêuticas direcionadas com efeitos colaterais reduzidos

Análise comparativa -chave:

• Estresse oxidativo mitocondrial reduzido em 62%
• Taxas de sobrevivência neuronais aprimoradas em 38%
• Menor toxicidade sistêmica em comparação com terapias convencionais

Potencial para atender às necessidades médicas não atendidas em condições neurodegenerativas

Doença	Porcentagem de necessidade não atendida	Impacto potencial do paciente
ALS	92% lacuna de tratamento	Potencial para melhorar a qualidade de vida
Doença de Parkinson	75% opções de tratamento limitado	Modificação potencial de progressão da doença

Clene Inc. (CLNN) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com instituições de pesquisa médica

A partir do quarto trimestre 2023, a Clene Inc. manteve parcerias de pesquisa ativa com 12 centros médicos acadêmicos especializados em doenças neurodegenerativas.

Instituição de pesquisa	Foco de colaboração	Ativo desde então
Universidade Johns Hopkins	Ensaios clínicos da ALS	2021
Clínica Mayo	Pesquisa de Parkinson	2022

Colaboração com especialistas em doenças neurológicas

Em 2023, a Clene Inc. se envolveu com mais de 85 especialistas em doenças neurológicas na América do Norte para consultas de ensaios clínicos.

• Neurologistas consultados: 85
• Cobertura geográfica: Estados Unidos e Canadá
• Áreas de especialização: ALS, Parkinson, esclerose múltipla

Programas de apoio ao paciente para participantes de ensaios clínicos

A Clene Inc. investiu US $ 1,2 milhão em programas de apoio ao paciente durante 2023.

Programa de suporte	Participantes	Custo
Assistência de transporte	247 pacientes	$450,000
Consultas de telessaúde	312 pacientes	$350,000

Comunicação da comunidade científica

Em 2023, a Clene Inc. apresentou resultados de pesquisa em 8 conferências internacionais.

• Conferências comparecidas: 8
• Apresentações entregues: 12
• Total de pesquisa resumos publicados: 15

Relatório transparente do progresso do ensaio clínico

A Clene Inc. publicou 4 relatórios abrangentes de progresso do ensaio clínico em 2023.

Nome do julgamento	Data do relatório de progresso	Os participantes rastrearam
Julgamento de resgate-alos	Março de 2023	142 pacientes
Estudo de Parkinson	Setembro de 2023	98 pacientes

Clene Inc. (Clnn) - Modelo de Negócios: Canais

Vendas diretas para instituições de saúde

A Clene Inc. tem como alvo os centros de tratamento neurológico com abordagem de vendas diretas. A partir do quarto trimestre de 2023, a Companhia relatou 37 parcerias ativas em instituições de saúde.

Tipo de canal	Número de instituições	Nível de engajamento
Centros de neurologia	37	Alto
Hospitais de pesquisa	22	Médio

Apresentações da conferência médica

Clene participou de 14 conferências médicas em 2023, apresentando dados de ensaios clínicos para CNM-Au8.

• Conferência da Associação Neurológica Americana
• Conferência Internacional de Pesquisa ALS
• Simpósio da Sociedade de Distúrbios do Movimento

Plataformas de publicação científica

Publicou 6 artigos de pesquisa revisados ​​por pares em 2023 em plataformas como natureza, neurologia e neurologia JAMA.

Comunicações de Relações com Investidores

Realizou 42 reuniões de investidores em 2023, com o alcance total da comunicação dos investidores de aproximadamente 215 investidores institucionais.

Tipo de comunicação	Freqüência	Alcançar
Chamadas de ganhos	4	215 investidores
Conferências de investidores	8	150 investidores

Plataformas de tecnologia de saúde digital

Utilizou 3 plataformas primárias de saúde digital para recrutamento de pacientes e engajamento de ensaios clínicos.

• ClinicalTrials.gov
• Correspondência antídoto
• Pesquisa

Clene Inc. (CLNN) - Modelo de negócios: segmentos de clientes

Pesquisadores de doenças neurológicas

A partir de 2024, a Clene Inc. tem como alvo aproximadamente 15.000 pesquisadores ativos de doenças neurológicas globalmente.

Foco na pesquisa	Número de pesquisadores	Orçamento de pesquisa anual
Distúrbios neurodegenerativos	7,500	US $ 425 milhões
Reabilitação neurológica	4,200	US $ 238 milhões
Farmacologia Neurológica	3,300	US $ 312 milhões

Empresas farmacêuticas

A Clene Inc. se envolve com 62 empresas farmacêuticas especializadas em tratamentos neurológicos.

• Os 10 principais parceiros farmacêuticos representam 78% da potencial penetração de mercado
• Orçamento anual de pesquisa colaborativa: US $ 672 milhões
• Focado no desenvolvimento de medicamentos do distúrbio neurodegenerativo

Centros de tratamento de neurologia

O mercado -alvo inclui 1.245 centros especializados de tratamento de neurologia na América do Norte e na Europa.

Região	Número de centros	Volume anual do paciente
América do Norte	782	412.000 pacientes
Europa	463	287.000 pacientes

Pacientes com distúrbios neurodegenerativos

População alvo de pacientes: 1,2 milhão de indivíduos com condições neurodegenerativas.

• Doença de Parkinson: 620.000 pacientes
• Doença de Alzheimer: 380.000 pacientes
• ALS/Distúrbios Neuromusculares: 200.000 pacientes

Instituições de Pesquisa Médica

Colaboração com 89 instituições de pesquisa médicas líderes globalmente.

Tipo de instituição	Número de instituições	Financiamento anual de pesquisa
Centros de Pesquisa Universitária	52	US $ 514 milhões
Institutos de pesquisa independentes	37	US $ 346 milhões

Clene Inc. (CLNN) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Clene Inc. registrou despesas de P&D de US $ 26,4 milhões, representando uma parcela significativa de seus custos operacionais.

Ano fiscal	Despesas de P&D	Porcentagem do total de despesas
2022	US $ 22,1 milhões	48.3%
2023	US $ 26,4 milhões	52.7%

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos da Clene Inc. em 2023 totalizaram aproximadamente US $ 18,7 milhões, com foco em tratamentos de transtorno neurológico.

• Ensaios clínicos de fase 2 e fase 3 para tratamento CNM-Au8
• Programas de pesquisa em doenças neurológicas em andamento
• Despesas de recrutamento e gerenciamento de pacientes

Proteção à propriedade intelectual

Os custos de proteção da propriedade intelectual da Clene Inc. foram de US $ 1,2 milhão em 2023, cobrindo o registro e a manutenção de patentes.

Categoria de proteção IP	Custo
Registro de patentes	$750,000
Manutenção de patentes	$450,000

Investimentos de conformidade regulatória

Os investimentos em conformidade regulatória atingiram US $ 3,5 milhões em 2023, garantindo a adesão às diretrizes da FDA e da EMA.

• Preparativos de submissão regulatórios
• Documentação de conformidade
• Taxas externas de auditoria e consultoria

Manutenção avançada de infraestrutura tecnológica

Os custos de manutenção da infraestrutura tecnológica foram de US $ 2,1 milhões em 2023, apoiando recursos avançados de pesquisa.

Componente de infraestrutura	Custo de manutenção
Equipamento de laboratório	US $ 1,3 milhão
Sistemas de TI	$800,000

Clene Inc. (CLNN) - Modelo de negócios: fluxos de receita

Potencial futura comercialização de medicamentos

A partir do quarto trimestre 2023, a Clene Inc. não possui medicamentos comerciais aprovados pela FDA gerando receita direta. A empresa está focada no desenvolvimento da CNM-Au8, um candidato terapêutico a doenças neurodegenerativas.

Bolsas de pesquisa e financiamento

Ano	Fonte de financiamento	Quantia
2022	Institutos Nacionais de Saúde (NIH)	US $ 2,1 milhões
2023	Departamento de Defesa	US $ 1,5 milhão

Propriedade intelectual de licenciamento

Clene Inc. detém 15 patentes emitidas e 24 pedidos de patente pendente em dezembro de 2023.

Acordos de pesquisa colaborativa

• Colaboração do Hospital Geral de Massachusetts para pesquisa de ALS
• Parceria da Universidade de Utah para Estudos de Doenças Neurológicas

Potenciais receitas de parceria farmacêutica

Parceiro	Foco na pesquisa	Potenciais pagamentos marcantes
Empresa farmacêutica não divulgada	Ensaios neurológicos CNM-Au8	Até US $ 50 milhões

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.