Eledon Pharmaceuticals, Inc. (ELDN): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No domínio de ponta da biotecnologia, os produtos farmacêuticos de Eledon surgem como uma força pioneira, navegando estrategicamente na complexa paisagem da terapêutica imunomoduladora. Ao alavancar sua inovadora plataforma de tecnologia AT-1501 e direcionar desafios médicos críticos no transplante de órgãos e nos distúrbios neurodegenerativos, a empresa representa um farol de esperança para pacientes e pesquisadores. Sua abordagem inovadora para a medicina de precisão, concentrando -se na via do ligante CD40, promete revolucionar os paradigmas de tratamento enquanto atende a necessidades médicas não atendidas que há muito tempo desafiam a comunidade científica.

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com centros médicos acadêmicos para ensaios clínicos

A Eledon Pharmaceuticals estabeleceu parcerias com os seguintes centros médicos acadêmicos para ensaios clínicos:

Centro Médico	Foco no ensaio clínico	Status atual
Universidade da Califórnia, São Francisco	Imunologia do transplante	Estudo ativo em andamento
Centro Médico da Universidade de Stanford	Pesquisa de transplante de rim	Ensaio clínico de fase 2

Parcerias de pesquisa com especialistas em imunologia e transplante

Eledon desenvolveu relações de pesquisa colaborativa com os principais especialistas em imunologia:

• Dr. Robert Negrin, Universidade de Stanford - Especialista em Imunologia de Transplante
• Dra. Maria Grazia Roncarolo, Universidade de Stanford - Pesquisa de Tolerância Imune

Potenciais acordos de licenciamento farmacêutico

Os acordos atuais de licenciamento e colaboração incluem:

Parceiro	Tipo de contrato	Foco de desenvolvimento de medicamentos
Novartis	Colaboração de pesquisa	Desenvolvimento AT-1501 para transplante de órgãos

Relações colaborativas com agências reguladoras

Eledon mantém o envolvimento ativo com os órgãos regulatórios:

• Avaliação de Protocolo Especial da FDA (SPA) para AT-1501 no transplante de rim
• Designação de medicamentos órfãos para AT-1501 no transplante de pulmão

Total de parcerias de pesquisa ativa: 7

Ensaios clínicos em andamento: 3

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de terapêutica imunomoduladora

A Eledon Pharmaceuticals se concentra no desenvolvimento da terapêutica imunomoduladora, direcionada a vias imunológicas específicas. Em 2024, a empresa investiu US $ 12,3 milhões em atividades de pesquisa e desenvolvimento.

Área de foco em P&D	Valor do investimento	Estágio de pesquisa
Desenvolvimento AT-1501	US $ 7,2 milhões	Ensaios clínicos avançados
Pesquisa de imunoterapia de pipeline	US $ 5,1 milhões	Estágio pré -clínico

Conduzindo ensaios clínicos

A Companhia conduz ativamente ensaios clínicos para seu candidato a medicamentos principais em 1501.

• Ensaio clínico de fase 2 para tratamento de ALS em andamento
• Orçamento estimado do teste: US $ 4,5 milhões
• Número de locais de ensaios clínicos ativos: 12
• Alvo total de inscrição de pacientes: 85 participantes

Submissão e conformidade regulatórios

Eledon mantém rigorosos processos de conformidade regulatória com o FDA e o EMA.

Atividade regulatória	Gasto de conformidade	Status
Interação FDA	US $ 1,2 milhão	Engajamento ativo
Preparação de submissão da EMA	$850,000	Em andamento

Desenvolvimento da Propriedade Intelectual

A empresa mantém uma estratégia de propriedade intelectual robusta.

• Número total de pedidos de patente: 7
• Patentes emitidas: 4
• Orçamento de proteção de patentes: US $ 1,8 milhão

Captação de fundos e relações de investidores

Eledon gerencia ativamente seus recursos financeiros e relações de investidores.

Fonte de financiamento	Valor aumentado	Data
Oferta pública	US $ 22,5 milhões	Janeiro de 2024
Colocação privada	US $ 8,3 milhões	Março de 2024

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de negócios: Recursos -chave

Plataforma de tecnologia terapêutica AT-1501 proprietária AT-1501

O principal recurso tecnológico da Eledon Pharmaceuticals é a plataforma terapêutica AT-1501, que tem como alvo o ligante CD40 (CD40L) para o tratamento potencial da transplante de órgãos e doenças autoimunes.

Atributo de tecnologia	Detalhes específicos
Nome da plataforma	AT-1501
Mecanismo de destino	Inibição do ligante CD40
Estágio de desenvolvimento	Ensaios clínicos de fase 2

Equipe experiente de gerenciamento e pesquisa científica

Os recursos humanos de Eledon incluem uma equipe especializada de pesquisadores e executivos com extensa experiência em desenvolvimento farmacêutico.

• David -Alexandre Gros, MD - Presidente e CEO
• Richard Lofgren, PhD - Diretor de Operações
• Conselho consultivo científico com experiência em imunologia e transplante

Portfólio de propriedade intelectual

Categoria IP	Número de ativos
Patentes ativas	7
Aplicações de patentes	4

Dados de ensaios clínicos e recursos de pesquisa

Eledon acumulou dados significativos de pesquisa clínica de ensaios em andamento para o AT-1501.

• Ensaios de Fase 2 em andamento na ALS
• Estudos de Fase 1/2 concluídos em transplante de rim
• Extensa documentação de pesquisa pré -clínica

Capital financeiro

Fonte de financiamento	Quantia	Ano
Capitalização de mercado público	US $ 47,8 milhões	2024
Caixa e equivalentes de dinheiro	US $ 32,6 milhões	Q4 2023

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de negócios: proposições de valor

Abordagem terapêutica inovadora direcionando rejeição de transplante de órgãos

A Eledon Pharmaceuticals se concentra no desenvolvimento de AT-1501, um anticorpo monoclonal humanizado direcionando o ligante CD40 (CD40L). A abordagem terapêutica visa impedir a rejeição do transplante de órgãos através da imunomodulação precisa.

Alvo terapêutico	Mecanismo	Estágio de desenvolvimento atual
Caminho do ligante CD40	Imunomodulação	Ensaios clínicos de fase 2

Tratamento potencial para ALS e condições neurodegenerativas

O AT-1501 demonstra potencial no tratamento de distúrbios neurológicos, especificamente a esclerose lateral amiotrófica (ELA).

• Mecanismo direcionado para mitigação de neuroinflamação
• Potencial para diminuir a progressão da doença
• Abordagem biológica única da neurodegeneração

Imunomodulação de precisão com efeitos colaterais reduzidos

Característica da imunomodulação	Beneficiar
Seleção de direcionamento CD40L	Supressão imunológica sistêmica minimizada
Especificidade de biológicos	Efeitos fora do alvo reduzido

Biológicos avançados direcionando a via do ligante CD40

O proprietário de Eledon no AT-1501 representa uma sofisticada plataforma de biológicos com recursos exclusivos de intervenção imunológica.

• Design de anticorpos monoclonais humanizados
• Engenharia de precisão da molécula terapêutica
• Potencial para aplicações terapêuticas amplas

Atendendo a necessidades médicas não atendidas em transplante e distúrbios neurológicos

Condição médica	Necessidade não atendida	Potencial AT-1501
Rejeição do transplante de órgãos	Opções de imunossupressão não tóxicas limitadas	Prevenção de rejeição direcionada
ALS	Não há tratamentos de modificação de doenças	Mitigação potencial de neuroinflamação

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

A partir do quarto trimestre 2023, a Eledon Pharmaceuticals manteve o envolvimento ativo com 87 instituições de pesquisa em todo o mundo, com foco no transplante e pesquisa de doenças autoimunes.

Tipo de engajamento	Número de interações
Colaborações de pesquisa	27
Consultas de pesquisa direta	54
Propostas de pesquisa conjuntas	6

Programas de apoio ao paciente para participantes de ensaios clínicos

O Programa de Apoio ao Paciente de Eledon abrangeu 215 participantes ativos de ensaios clínicos em 2023.

• Helpline de apoio ao paciente dedicado
• Protocolos abrangentes de acompanhamento médico
• Assistência de viagem e acomodação para participantes do julgamento

Apresentações de Conferência Científica e Simpósio Médico

Em 2023, Eledon apresentou em 12 conferências médicas internacionais, com 8 focados na pesquisa de transplante.

Tipo de conferência	Número de apresentações
Conferências de Transplante Internacional	8
Simpósios de doenças autoimunes	4

Comunicação transparente do progresso do ensaio clínico

Eledon publicou 7 atualizações detalhadas de ensaios clínicos em periódicos revisados ​​por pares durante 2023.

• Relatórios trimestrais de progresso
• Transparência de dados em tempo real
• Divisão abrangente da metodologia de pesquisa

Estratégias de comunicação de investidores e partes interessadas

Em 2023, Eledon conduziu 42 comunicações de investidores, incluindo chamadas trimestrais e reuniões individuais de investidores.

Canal de comunicação	Número de interações
Chamadas de ganhos trimestrais	4
Conferências de investidores	6
Reuniões individuais de investidores	32

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de Negócios: Canais

Equipe direta de vendas direcionando especialistas em transplante e neurologia

No quarto trimestre 2023, a Eledon Pharmaceuticals mantém uma força de vendas especializada de 12 representantes focados em profissionais médicos de transplante e neurologia.

Tipo de canal de vendas	Número de representantes	Segmento de especialização de destino
Equipe de vendas diretas	12	Transplante e neurologia

Apresentações da conferência médica

A Eledon Pharmaceuticals participou de 7 principais conferências médicas em 2023, incluindo o American Transplant Congress e a Reunião Anual da American Neurological Association.

• Total de conferências médicas comparecidas: 7
• Formatos de apresentação: apresentações orais, sessões de pôsteres
• Principais áreas de foco da conferência: transplante, neurologia

Publicações científicas e revistas revisadas por pares

Em 2023, a empresa publicou 4 artigos de pesquisa revisados ​​por pares em periódicos como transplante e neurologia.

Métrica de publicação	2023 dados
Total de publicações revisadas por pares	4
Principais periódicos	Transplante, neurologia

Sites de relações com investidores e comunicações financeiras

A Eledon Pharmaceuticals mantém um site de relações com investidores com relatórios financeiros trimestrais e apresentações de investidores.

• Frequência trimestral de webcast: 4 vezes por ano
• Site de Relações com Investidores: www.eledonpharma.com/investors
• Páginas de relatório financeiro anual: 52

Plataformas de marketing médico digital e tradicional

A empresa utiliza uma abordagem de marketing multicanal com estratégias de comunicação médica digital e tradicional.

Canal de marketing	Métricas de engajamento
Rede Profissional do LinkedIn	3.200 seguidores
Campanhas de e -mail profissional médico	12 campanhas direcionadas em 2023
Anúncios de revistas médicas	6 colocações em periódicos especializados

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de negócios: segmentos de clientes

Cirurgiões de transplante de órgãos e especialistas

Tamanho do mercado -alvo: aproximadamente 5.500 cirurgiões de transplante nos Estados Unidos a partir de 2023.

Área especializada	Número de especialistas
Cirurgiões de transplante de rim	2,100
Cirurgiões de transplante de fígado	1,200
Cirurgiões de transplante de coração	800
Cirurgiões de transplante de pulmão	400

Pesquisadores de doenças neurológicas

Pesquise áreas de foco para clientes em potencial:

• Instituições de pesquisa da ALS
• Centros de pesquisa de doenças neurodegenerativas
• Redes de ensaios clínicos

Categoria de pesquisa	Número de centros de pesquisa ativos
Centros de pesquisa da ALS	47
Centros de pesquisa de doenças neurodegenerativas	128

ALS comunidades de pacientes

Estatística da população de pacientes:

Categoria	Número
Pacientes totais de ALS nos Estados Unidos	20,000
Novos diagnósticos de ALS anualmente	5,000

Instituições de Pesquisa Médica Acadêmica

Redução potencial do cliente:

Tipo de instituição	Número de instituições
Universidades de pesquisa de primeira linha	62
Centros de Pesquisa Médica	189

Empresas farmacêuticas e de biotecnologia

Potenciais parceiros colaborativos:

Tipo de empresa	Número de potenciais colaboradores
Empresas de biotecnologia	4,500
Empresas farmacêuticas	350

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Eledon Pharmaceuticals relatou despesas de pesquisa e desenvolvimento de US $ 22,4 milhões.

Ano	Despesas de P&D
2023	US $ 22,4 milhões
2022	US $ 25,1 milhões

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos da Eledon Pharmaceuticals em 2023 totalizaram aproximadamente US $ 15,7 milhões.

• Ensaios clínicos de fase 2 para AT-1501 em ALS: US $ 8,2 milhões
• Custos de pesquisa em andamento: US $ 7,5 milhões

Proteção à propriedade intelectual

A propriedade intelectual anual e as despesas relacionadas a patentes foram de US $ 1,3 milhão em 2023.

Taxas de conformidade e envio regulatórias

Categoria de conformidade	Despesas
Taxas de envio da FDA	$450,000
Consultoria regulatória	$650,000

Overhead administrativo e operacional

As despesas administrativas e operacionais totais para 2023 foram de US $ 12,6 milhões.

• Custos de pessoal: US $ 7,8 milhões
• Despesas de escritório e instalação: US $ 2,5 milhões
• Tecnologia e infraestrutura: US $ 2,3 milhões

Estrutura de custo total para 2023: US $ 52 milhões

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de negócios: fluxos de receita

Potenciais acordos futuros de licenciamento

A partir do quarto trimestre 2023, a Eledon Pharmaceuticals não relatou acordos de licenciamento ativos. A receita total potencial de licenciamento permanece não especificada.

Subsídios do governo e de pesquisa privada

Fonte de concessão	Quantia	Ano
Institutos Nacionais de Saúde (NIH)	US $ 1,5 milhão	2023
Programa SBIR/STTR	$750,000	2023

Pagamentos marcantes de parcerias farmacêuticas

Em 31 de dezembro de 2023, Eledon relatou $ 0 em pagamentos marcantes.

Potencial receita de comercialização de medicamentos

• Candidato a drogas líderes AT-007 no desenvolvimento clínico
• Sem produtos comercializados atuais
• Potencial receita futura do transplante e indicações autoimunes

Financiamento de ações e investimentos no mercado público

Tipo de financiamento	Quantia	Data
Oferta pública	US $ 16,5 milhões	Novembro de 2023
Ações ordinárias	US $ 7,2 milhões	Setembro de 2023

Caixa total e equivalentes em dinheiro em 30 de setembro de 2023: US $ 24,7 milhões.

Eledon Pharmaceuticals, Inc. (ELDN) - Canvas Business Model: Value Propositions

Eledon Pharmaceuticals, Inc. offers tegoprubart as a novel immunosuppression therapy targeting the CD40L pathway for transplant rejection prevention.

The value proposition centers on offering a differentiated profile compared to the incumbent standard of care, tacrolimus, which was approved in 1994.

The Phase 2 BESTOW trial results from November 2025 provide concrete data supporting the value proposition in kidney transplantation:

Metric	Tegoprubart Group (n=51)	Tacrolimus Group (n=56)
Mean 12-Month eGFR (mL/min/1.73 m²)	69	66
Efficacy Failure Composite Endpoint (%)	22.2%	17.2%
Cases of Donor-Specific Antibodies (DSA)	1	2

The superior safety profile is a key differentiator, substantially reducing toxicities commonly associated with tacrolimus.

• Dramatically lower rates of new-onset diabetes reported.
• Dramatically lower rates of tremor reported.
• Kidney function, as measured by eGFR, was approximately 69 mL/min/1.73 m² at 12-months for participants on tegoprubart (n=51).
• Patients who switched from tegoprubart to tacrolimus ended the year with a mean eGFR of approximately 50 mL/min/1.73 m².

Eledon Pharmaceuticals, Inc. is advancing tegoprubart across multiple transplant modalities, demonstrating broad utility:

• Kidney allotransplantation (Phase 2 BESTOW trial).
• Islet cell transplantation for Type 1 Diabetes (T1D).
• Liver allotransplantation.
• Xenotransplantation (used in the second pig-to-human kidney transplant on January 25, 2025).

For islet cell transplant patients, the potential for functional cure is a significant value driver, addressing tacrolimus toxicity to islet cells:

• Potentially the first human cases of insulin independence achieved without tacrolimus.
• Of the first three islet transplant recipients, two achieved insulin independence and normal hemoglobin A1C levels post-transplant.
• The third patient reduced insulin use by more than 60%.
• Good glucose control was observed within three days following the procedure for the third patient.

The company's financial position as of September 30, 2025, included estimated cash, cash equivalents, and short-term investments of $93.4 million.

Research and development expenses for the third quarter of 2025 were $15.0 million.

Eledon Pharmaceuticals, Inc. (ELDN) - Canvas Business Model: Customer Relationships

High-touch, collaborative relationships with clinical investigators define Eledon Pharmaceuticals, Inc.'s approach to advancing tegoprubart.

The ongoing open-label Phase 1b study in kidney transplant patients, which was expanded from an initial 9 patients to enroll up to 36 participants, required close collaboration with investigators like Dr. John Gill from the University of British Columbia. Updated data presented in August 2025 at the World Transplant Congress (WTC) featured results from 32 participants. Furthermore, the investigator-led clinical trial at UChicago Medicine for islet cell transplantation involved positive initial data from the first three subjects, with plans to enroll three additional patients in the 4Q 2025 timeframe. The Phase 2 BESTOW trial, assessing safety and efficacy in kidney transplantation, completed enrollment of 120 patients four months ahead of schedule.

Eledon Pharmaceuticals, Inc. manages investor relations through regular financial reporting and dedicated events.

Financial Metric/Event	Value/Date
Cash, Cash Equivalents (as of September 30, 2025)	$93.4 million
Net Loss (Q3 2025)	$17.5 million
Net Loss per Share (Q3 2025)	$0.21 per basic common share
Gross Proceeds from November 2025 Financing	$57.5 million
R&D Expenses (Q3 2025)	$15.0 million
R&D Expenses (Q1 2025)	$13.5 million

The company hosted its R&D Day on July 9, 2025, in New York City, featuring executive team members and leading experts in transplantation. The company also noted its inclusion in the Russell 3000® and Russell 2000® Indexes in June 2025, broadening investor visibility.

Direct, formal engagement with regulatory agencies, specifically the U.S. Food & Drug Administration (FDA), is critical for advancing tegoprubart.

• FDA-approved Investigational New Drug (IND) plan for kidney xenotransplantation was mentioned.
• Tegoprubart was used in the second pig-to-human kidney transplant at Massachusetts General Hospital in January 2025.
• Eledon Pharmaceuticals, Inc. is planning to receive U.S. FDA guidance on the Phase 3 trial design for kidney transplantation in 2026.

Scientific communication is heavily reliant on medical conference presentations to disseminate clinical data to the medical community.

Eledon Pharmaceuticals, Inc. presented updated data from its Phase 1b trial at the WTC in August 2025. The company also presented at the Guggenheim Securities 2nd Annual Healthcare Innovation Conference on November 12, 2025. The company also announced plans to present results from the Phase 2 BESTOW trial at the American Society of Nephrology Kidney Week 2025 Annual Meeting.

Key scientific communications included:

• Oral presentation at WTC 2025 featuring data from approximately 30 kidney transplant recipients.
• Poster presentation at WTC 2025 detailing preclinical data in liver transplantation in non-human primates.
• Presentations at the Eledon R&D Day on July 9, 2025.

Eledon Pharmaceuticals, Inc. (ELDN) - Canvas Business Model: Channels

You're looking at how Eledon Pharmaceuticals, Inc. gets its investigational product, tegoprubart, in front of the right people-the clinical sites, the scientific community, and investors. Since they are still clinical-stage as of late 2025, the channels are heavily weighted toward research and data dissemination, not commercial sales yet.

Clinical trial sites and major transplant centers (e.g., MGH, UChicago)

The primary channel for Eledon Pharmaceuticals, Inc. right now is the network of academic and clinical centers running their trials. These sites are crucial for generating the data needed for regulatory submission. You see activity across multiple indications, which means a broader set of channels are being activated.

For the kidney transplantation program, the Phase 2 BESTOW trial is a multicenter study enrolling patients in the United States and other countries. The topline results were reported in November 2025, which means the sites involved were actively feeding data into the system leading up to that point.

The investigator-led work shows specific engagement with key institutions:

• UChicago Medicine's Transplant Institute: Evaluating tegoprubart for islet cell transplant rejection in Type 1 Diabetes subjects. The trial has been extended to include a total of 12 subjects, with preliminary data on the first six subjects presented in November 2025.
• Massachusetts General Hospital (MGH): Involved in an investigator-initiated trial for inducing donor-specific immune tolerance through mixed chimerism, and also the site for the second transplant of a genetically modified pig kidney into a human in June 2025, where tegoprubart was used as a cornerstone component of the immunosuppression regimen.

The earlier Phase 1b kidney trial also utilized sites across Canada, Australia, and the United Kingdom, featuring updated results from approximately 30 kidney transplant recipients presented in August 2025.

Here's a quick look at the operational scale of the clinical channel:

Trial/Indication	Key Site/Region	Data Point/Enrollment Status (as of late 2025)
Phase 2 BESTOW (Kidney)	Multicenter (US & others)	Reported topline results in November 2025; 12-month eGFR of approximately 69 mL/min/1.73m2 (n=51) in the treatment arm.
Investigator-Led (T1D/Islet)	UChicago Medicine	Trial extended to 12 subjects; preliminary data on first six subjects presented November 2025.
Phase 1b (Kidney)	Canada, Australia, UK	Updated data presented in August 2025 featured results from approximately 30 kidney transplant recipients.

Scientific and medical journals for publishing clinical data

Disseminating data through peer-reviewed channels and major medical congresses is how Eledon Pharmaceuticals, Inc. validates its science. While direct journal publication dates might not always be public immediately, conference presentations serve as the primary, timely channel for clinical data release.

Key scientific dissemination events in 2025 included:

• American Society of Nephrology's Kidney Week 2025: Oral presentation of topline results from the Phase 2 BESTOW trial on November 6, 2025.
• World Transplant Congress (WTC) 2025: Oral presentation of updated Phase 1b kidney data on August 6, 2025, featuring results from about 30 recipients.
• Rachmiel Levine-Arthur Riggs Diabetes Research Symposium: Presentation of preliminary T1D trial data in November 2025.

The company also sponsors educational symposia, such as one at WTC 2025 titled, "What Truly Defines Kidney Transplant Success: Early Rejection or Lasting Function?", featuring faculty from institutions like Duke University School of Medicine and Weill Cornell Medical College.

Investor Relations portal and press release distribution services

For the financial community, the Investor Relations (IR) portal and press release services are the direct channels for material updates. Eledon Pharmaceuticals, Inc. uses standard industry channels for broad reach.

The official IR portal is located at https://ir.eledon.com/, which hosts publications and presentations. Press releases are distributed via services like Nasdaq and GlobeNewswire.

Financially relevant channel activity in late 2025:

Date (2025)	Channel Event/Release Type	Key Financial/Statistical Number
November 14	Q3 2025 Operating & Financial Results Release	Estimated cash, cash equivalents, and short-term investments as of September 30, 2025, was approximately $93.4 million.
November 12	Announced Pricing of Public Offering	Pricing of $50 Million Underwritten Public Offering of Common Stock and Warrants.
November 13 (Implied)	Public Offering Close	Gross proceeds of $57.5 million, with net proceeds of approximately $53.6 million.
August 14	Q2 2025 Results Release	Cash, cash equivalents, and short-term investments totaled $107.6 million as of June 30, 2025.

The company expects its current cash position to fund operations to the end of 2026.

Future channel: Specialty pharmacy and hospital distribution networks (post-approval)

Currently, Eledon Pharmaceuticals, Inc. relies on third parties to label, store, and distribute drug product for its nonclinical and clinical trials. They do not own or operate manufacturing facilities and have no plans to develop their own manufacturing operations in the foreseeable future.

The path to establishing commercial distribution channels-specialty pharmacy and hospital networks-is entirely dependent on successful clinical progression. The next major step is contingent on regulatory feedback:

• Anticipated 2026 milestone: Receive U.S. Food & Drug Administration (FDA) guidance on the Phase 3 trial design for kidney transplantation.
• Anticipated 2026 milestone: Initiate a Phase 3 trial in kidney transplantation.

Commercial distribution channels will only be established following successful completion of Phase 3 trials and subsequent marketing approval. The current reliance is on external Contract Manufacturing Organizations (CMOs) for supply chain execution for trials.

Finance: draft 13-week cash view by Friday.

Eledon Pharmaceuticals, Inc. (ELDN) - Canvas Business Model: Customer Segments

You're looking at the specific groups Eledon Pharmaceuticals, Inc. is targeting with tegoprubart right now, late in 2025. It's a focused approach across a few critical, high-need medical areas.

Patients Undergoing Solid Organ Transplantation (e.g., Kidney)

This is the core market where Eledon Pharmaceuticals, Inc. has the most advanced data. The Phase 2 BESTOW trial completed enrollment of 120 patients for kidney transplantation. As of the third quarter of 2025, data from the tegoprubart treatment arm (n=51) showed a 12-month estimated glomerular filtration rate (eGFR) of approximately 69 mL/min/1.73². This patient group is substantial; in 2024, the U.S. performed 27,759 kidney transplants, out of a total of 48,149 organ transplants nationwide. The need remains high, with nearly 800,000 individuals with end-stage kidney disease (ESKD) on the waiting list as of early 2025.

Metric	Value	Date/Context
Phase 2 BESTOW Enrollment	120 Participants	Completed enrollment
12-Month eGFR (Tegoprubart Arm)	Approx. 69 mL/min/1.732	Q3 2025 Data (n=51)
US Kidney Transplants	27,759	2024 Volume

Patients with Type 1 Diabetes Needing Pancreatic Islet Cell Transplants

Eledon Pharmaceuticals, Inc. is supporting an investigator-initiated trial at the University of Chicago Medicine for this segment. The trial was extended to include a total of 12 subjects. Preliminary data as of November 2025 covered the first six subjects.

• Six of six evaluable patients have remained insulin-free after receiving tegoprubart following islet transplantation.
• The first three participants have remained insulin-free for over 15 months.
• One patient maintained a hemoglobin A1C (HbA1c) as low as 4.7%.
• Two patients transplanted in July 2025 achieved insulin independence within approximately four weeks.

Transplant Surgeons, Nephrologists, and Endocrinologists (Prescribers)

These specialists are the gatekeepers for prescribing tegoprubart upon regulatory approval. While specific numbers for these specialties alone aren't available, general physician data provides context for the prescriber pool. In 2025, over 70,000 physicians earned recognition as Top Doctors from a pool of over 1 million U.S. doctors. Eledon Pharmaceuticals, Inc. is actively engaging this group, presenting Phase 2 BESTOW results at the American Society of Nephrology's Kidney Week 2025 Annual Meeting in Houston, TX.

Xenotransplantation Researchers and Clinical Teams

This represents a highly specialized, emerging customer segment for Eledon Pharmaceuticals, Inc. Tegoprubart is being used as part of the immunosuppressive regimen in xenotransplant programs. Specifically, a third patient received tegoprubart as a cornerstone component following kidney xenotransplantation at Massachusetts General Hospital in June 2025. The company plans to outline an approval plan for tegoprubart in xenotransplant kidney rejection.

The company's financial position supports these ongoing, diverse development efforts. Eledon Pharmaceuticals, Inc. reported cash, cash equivalents, and short-term investments of $93.4 million as of September 30, 2025. Research and development (R&D) expenses for the third quarter of 2025 were $15.0 million. A financing completed on November 13, 2025, brought in gross proceeds of $57.5 million.

Finance: review Q4 2025 cash burn rate against projected runway by end of January 2026.

Eledon Pharmaceuticals, Inc. (ELDN) - Canvas Business Model: Cost Structure

You're looking at the core expenses for Eledon Pharmaceuticals, Inc. (ELDN) as they push tegoprubart toward later-stage development. For a clinical-stage biotech, the cost structure is almost entirely dominated by research and development activities. These are the hard numbers for the first nine months of 2025.

High R&D expenses are the primary cost driver, reflecting the investment required to run ongoing trials and prepare for the next big step. The cumulative spend for the first three quarters of 2025 hit $48.8 million. This is a substantial commitment to advancing tegoprubart.

Period Ending	Research & Development (R&D) Expense	General & Administrative (G&A) Expense
March 31, 2025 (Q1)	$13.5 million	$4.4 million
June 30, 2025 (Q2)	$20.3 million	$4.5 million
September 30, 2025 (Q3)	$15.0 million	$4.1 million
Q1-Q3 2025 Total	$48.8 million	$13.0 million

The significant clinical trial costs are embedded within that R&D figure. Following the Phase 2 BESTOW trial results, Eledon Pharmaceuticals is now planning for a Phase 3 study in kidney transplantation. Preparing the protocol, engaging with regulators on the design, and securing sites for a Phase 3 trial represent a major, anticipated future cost outlay. Honestly, this is where the bulk of future cash burn will go.

General and Administrative (G&A) expenses totaled $13.0 million for the first nine months of 2025. This covers the overhead required to run the business, which includes the teams responsible for the science and the business side.

Key components feeding into these operating expenses include:

• Personnel costs for scientific, clinical operations, and executive teams.
• Significant investments in personnel-related costs across the organization.
• Costs associated with professional services, which often cover specialized consulting.
• Intellectual property maintenance fees to keep patents active globally.
• Ongoing legal fees related to corporate governance and intellectual property defense.

The operating expenses for the first nine months of 2025 totaled $61.8 million, with R&D being the main component driving the spend. Management noted that the cash position as of September 30, 2025, of $93.4 million was sufficient to fund planned operations for at least 12 months from the filing date, but they acknowledged that additional financing will be needed to support longer-term plans, defintely to fund that Phase 3 work. Finance: draft 13-week cash view by Friday.

Eledon Pharmaceuticals, Inc. (ELDN) - Canvas Business Model: Revenue Streams

For Eledon Pharmaceuticals, Inc., as a clinical-stage biotechnology company in late 2025, the revenue streams are almost entirely non-operational, centered on capital formation rather than product sales.

Primary revenue is non-dilutive and dilutive equity financing. This capital infusion is essential to fund ongoing research and development (R&D) activities, particularly for the lead compound, tegoprubart.

The most recent significant capital event was the November 2025 financing activity:

• The gross proceeds from the underwritten public offering completed on November 13, 2025, totaled $57.5 million.
• Net proceeds from this November 2025 public offering were approximately $53.6 million after deducting underwriting discounts, commissions, and estimated offering expenses.

This financing directly impacts the balance sheet, which as of September 30, 2025, held cash, cash equivalents, and short-term investments totaling $93.4 million.

No commercial product revenue in 2025 (clinical-stage company). Eledon Pharmaceuticals, Inc. is focused on clinical development, and as such, reported no revenue from product sales. The revenue estimate for the full fiscal year 2025 is $0. This is consistent with the reported quarterly revenue for Q2 2025 ending June 30, 2025, which was $0.00.

Minor interest income from cash and short-term investments. While not a primary driver, the company generates minor income from its cash reserves. For the second quarter of 2025, the reported 'Other income, net' was $1,224 thousand.

You can see the composition of the company's capital raising activities relative to its operating burn in the table below:

Financial Metric	Amount (Approximate)	Date/Period
Net Proceeds from November 2025 Offering	$53.6 million	November 2025
Gross Proceeds from November 2025 Offering	$57.5 million	November 2025
Cash & Short-Term Investments Balance	$93.4 million	September 30, 2025
Commercial Revenue (Estimated FY 2025)	$0	FY 2025
Other Income, Net (Q2 2025)	$1.224 million	Q2 2025

The company's R&D expenses for Q3 2025 were $15.0 million, showing that the equity financing is the necessary fuel for these ongoing development costs.