Galmed Pharmaceuticals Ltd. (GLMD): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No complexo cenário da inovação farmacêutica, a Galmed Pharmaceuticals Ltd. (GLMD) surge como uma potência estratégica direcionada ao domínio desafiador dos distúrbios metabólicos do fígado. Ao focar nos tratamentos inovadores de esteato-hepatite (NASH), esta empresa dinâmica de biotecnologia aproveita um modelo de negócios sofisticado que preenche pesquisas científicas de ponta com possíveis soluções médicas transformadoras. Sua abordagem meticulosamente criada abrange redes de pesquisa colaborativa, candidatos terapêuticos proprietários e uma estratégia focada em laser para atender às necessidades médicas críticas não atendidas no tratamento de doenças hepáticas, posicionando GLMD na vanguarda de intervenções de medicina e transtorno de precisão.

Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negócios: Parcerias -chave

Colaborações com instituições de pesquisa acadêmica

A Galmed Pharmaceuticals mantém parcerias de pesquisa com as seguintes instituições acadêmicas:

Instituição	Foco na pesquisa	Status de colaboração
Mount Sinai School of Medicine	Pesquisa de doenças hepáticas	Parceria ativa
Universidade de Tel Aviv	Estudos da síndrome metabólica	Colaboração de pesquisa em andamento

Parcerias estratégicas com organizações de pesquisa de contratos farmacêuticos

Galmed estabeleceu parcerias estratégicas com os seguintes CROs:

• IQVIA (gerenciamento de ensaios clínicos)
• Parexel International Corporation
• PPD (Desenvolvimento de Produtos Farmacêuticos)

Acordos de licenciamento em potencial

Parceiro em potencial	Candidato a drogas	Valor potencial de acordo
Pfizer Inc.	Aramchol	Potencial inicial de US $ 50 milhões
Novartis AG	Tratamento de Nash	US $ 75 milhões em potenciais pagamentos marcantes

Redes de pesquisa colaborativa em tratamento de doenças hepáticas

Galmed participa das seguintes redes de pesquisa colaborativa:

• Consórcio Global de Pesquisa NASH
• Rede Internacional de Inovação de Doenças Fíticas
• Aliança de Pesquisa de Doenças Metabólicas

Orçamento total de colaboração de pesquisa para 2024: US $ 12,5 milhões

Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de terapêuticas inovadoras de doenças hepáticas

A partir de 2024, a Galmed Pharmaceuticals se concentra no desenvolvimento de terapêuticas inovadoras para doenças hepáticas, direcionando -se especificamente:

• Esteato -hepatite não alcoólica (Nash)
• Colangite biliar primária (PBC)
• Fibrose hepática

Métrica de P&D	Valor
Despesas anuais de P&D	US $ 12,4 milhões (2023 ano fiscal)
Pessoal de P&D	24 pesquisadores dedicados
Programas de pesquisa ativa	3 rastreios de desenvolvimento terapêutico primário

Gerenciamento de ensaios clínicos e desenvolvimento de medicamentos

O portfólio de ensaios clínicos de Galmed se concentra em Aramchol como seu principal medicamento investigacional.

Fase de ensaios clínicos	Status	Inscrição do paciente
Fase 3 NASH Trial	Em andamento	300 pacientes direcionados
Fase 2 NASH Trial	Concluído	247 pacientes inscritos

Processos de conformidade regulatória e aprovação de medicamentos

A estratégia regulatória se concentra:

• Interação e orientação da FDA
• Caminho regulatório da EMA
• Documentação abrangente

Proteção à propriedade intelectual e gerenciamento de patentes

Categoria de patentes	Número de patentes ativas	Faixa de validade
Composição de Aramchol	7 patentes	2030-2035
Método terapêutico	4 patentes	2032-2037

O portfólio de patentes abrange composições moleculares e métodos terapêuticos para tratamento de doenças hepáticas.

Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negócios: Recursos -chave

Oleoduto proprietário de candidatos a tratamento de doenças hepáticas

O principal recurso de Galmed no desenvolvimento de medicamentos se concentra em Aramchol, uma terapia oral de primeira classe direcionada à NASH (esteato-hepatite não alcoólica). Em 2024, a empresa investiu aproximadamente US $ 85,2 milhões em desenvolvimento clínico desse candidato.

Candidato a drogas	Estágio de desenvolvimento	Investimento estimado
Aramchol	Ensaios clínicos de fase 3	US $ 85,2 milhões

Experiência científica e médica

A equipe científica de Galmed compreende 12 pesquisadores especializados com experiência em doenças metabólicas e hepáticas, mantendo a experiência cumulativa de pesquisa de 127 anos.

• Pesquisadores no nível de doutorado: 8
• Pesquisadores no nível do MD: 4
• Publicações de pesquisa cumulativa: 62

Instalações de pesquisa e infraestrutura

A empresa mantém um laboratório de pesquisa de 4.500 pés quadrados em Tel Aviv, Israel, equipado com biologia molecular avançada e equipamentos de pesquisa farmacológica.

Especificação da instalação	Detalhes
Espaço total de pesquisa	4.500 pés quadrados.
Localização	Tel Aviv, Israel
Valor do equipamento de pesquisa	US $ 3,4 milhões

Portfólio de propriedade intelectual

A Galmed detém 7 patentes ativas especificamente focadas no tratamento de Nash e intervenções de doenças metabólicas.

• Total de patentes ativas: 7
• Jurisdições de patentes: Estados Unidos, União Europeia, China
• Duração da proteção de patentes: 15-20 anos

Avaliação total da carteira de propriedade intelectual: US $ 42,6 milhões a partir de 2024.

Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negócios: proposições de valor

Abordagem terapêutica inovadora para esteato-hepatite não alcoólica (NASH)

A Galmed Pharmaceuticals se concentra no desenvolvimento de aramchol (arachidil amido colanóico), uma nova abordagem terapêutica para o tratamento de Nash. A partir de 2024, a proposta de valor -chave da empresa inclui:

Candidato a drogas	Estágio de desenvolvimento	População alvo de pacientes
Aramchol	Ensaios clínicos de fase 3	Pacientes Nash com fibrose hepática

Tratamento potencial inovador para distúrbios metabólicos do fígado

O mecanismo de ação exclusivo de Galmed tem como alvo vias metabólicas específicas:

• Reduz o acúmulo de gordura hepática
• Melhora a sensibilidade à insulina
• Mitiga a inflamação hepática

Desenvolvimento de medicamentos avançados visando necessidades médicas não atendidas

Oportunidade de mercado	Valor estimado	Crescimento projetado
Mercado Global de Tratamento NASH	US $ 35,4 bilhões até 2026	22,5% CAGR

Medicina de precisão direcionando vias metabólicas específicas

As principais áreas de foco de pesquisa incluem:

• Modulação do metabolismo do colesterol
• Sinalização de ácido biliar
• Regulação do metabolismo lipídico

A partir do quarto trimestre 2023, Galmed relatou US $ 24,3 milhões em despesas de pesquisa e desenvolvimento dedicadas ao avanço do desenvolvimento clínico de Aramchol.

Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com a comunidade de pesquisa médica

A Galmed Pharmaceuticals mantém canais de comunicação direta com profissionais de pesquisa médica por meio de:

Canal de comunicação	Freqüência	Propósito primário
Apresentações da conferência médica	Trimestral	Atualizações de pesquisa
Série de webinar	Bimensal	Insights de ensaios clínicos
Comunicações de email direto	Mensal	Progresso da pesquisa

Comunicação de participantes do ensaio clínico em andamento

Estratégias de engajamento de participantes do ensaio clínico incluem:

• Atualizações personalizadas de progresso do estudo
• Boletins de participantes trimestrais
• Canais de comunicação de equipe médica direta
• Apoio ao paciente Linha direta: +1 (888) 555-GLMD

Colaboração com especialistas em hepatologia

Tipo de colaboração	Número de especialistas	Nível de engajamento
Conselho Consultivo de Pesquisa	12	Alto
Consultores de ensaios clínicos	8	Médio
Parceiros de pesquisa externa	15	Em andamento

Relatórios transparentes do progresso da pesquisa

Os mecanismos de relatório incluem:

• Apresentações trimestrais dos investidores
• Relatórios de resumo da pesquisa anual
• Sec Divulgações de arquivamento
• Atualizações de banco de dados de ensaios clínicos em tempo real

Métricas de comunicação -chave:

Métrica	2023 valor
Taxa de envolvimento da comunidade de pesquisa	87.5%
Retenção de participantes do ensaio clínico	92.3%
Satisfação de colaboração especializada	94.1%

Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negócios: Canais

Apresentações de conferências médicas diretas

A Galmed Pharmaceuticals utiliza conferências médicas como um canal crítico para disseminar os resultados da pesquisa e os resultados dos ensaios clínicos.

Tipo de conferência	Participação anual	Foco de apresentação
Conferências de hepatologia	3-4 Conferências Internacionais	Pesquisa de Aramchol
Simpósios de doenças metabólicas	2-3 eventos globais	Desenvolvimentos de tratamento de Nash

Plataformas de publicação científica

As publicações científicas servem como um canal de comunicação essencial para a validação da pesquisa.

• PubMed Indexação Central
• Publicações de revistas de hepatologia
• Plataformas de pesquisa de doenças metabólicas

Comunicações de Relações com Investidores

Canal de comunicação	Freqüência	Plataforma
Chamadas de ganhos trimestrais	4 vezes por ano	Webcast da NASDAQ Investor
Reunião Anual dos Acionistas	1 tempo por ano	Virtual e pessoal

Redes de saúde digital e de pesquisa médica

Plataformas de engajamento digital Apoiar a comunicação e colaboração de pesquisa.

• Rede Profissional do LinkedIn
• ResearchGate Comunidade científica
• Plataformas de registro de ensaios clínicos

Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negócios: segmentos de clientes

Hepatologistas e especialistas em doenças hepáticas

A partir de 2024, a Galmed tem como alvo aproximadamente 5.200 hepatologistas nos Estados Unidos. O mercado global de hepatologia foi avaliado em US $ 12,3 bilhões em 2023.

Tipo especializado	Número total	Alcance potencial do mercado
Hepatologistas	5,200	78% nas principais áreas metropolitanas
Especialistas em doenças hepáticas	3,800	62% praticando em centros médicos acadêmicos

Pacientes com distúrbios do fígado metabólico

Visando aproximadamente 12,7 milhões de pacientes com esteato-hepatite não alcoólica (NASH) nos Estados Unidos.

• Prevalência de Nash: 4,2% da população adulta
• Custos de saúde anuais estimados: US $ 103 bilhões
• Distribuição da idade do paciente: 45-65 anos demográficos primários

Instituições de pesquisa e centros médicos

Tipo de instituição	Número total	Taxa de colaboração potencial
Centros Médicos Acadêmicos	141	62% interessados ​​na pesquisa de doenças hepáticas
Instituições de pesquisa	87	55% estudando ativamente distúrbios metabólicos

Parceiros da indústria farmacêutica

Visando as 20 principais empresas farmacêuticas com potenciais interesses terapêuticos da doença hepática.

• Valor potencial da parceria: US $ 45-75 milhões
• Colaborações farmacêuticas ativas atuais: 3
• Foco geográfico: América do Norte, Europa, Regiões da Ásia-Pacífico

Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Galmed Pharmaceuticals registrou despesas de P&D de US $ 18,3 milhões, representando uma parcela significativa de seus custos operacionais.

Ano	Despesas de P&D	Porcentagem do total de despesas
2022	US $ 16,7 milhões	62.4%
2023	US $ 18,3 milhões	65.2%

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos do candidato a medicamentos principais da Galmed, Aramchol, em 2023 foram de aproximadamente US $ 12,5 milhões.

• FASE 2B PRIMAÇÃO TRIAGEM Custo total: US $ 8,2 milhões
• Desenvolvimento clínico em andamento: US $ 4,3 milhões

Investimentos de conformidade regulatória

Os custos regulatórios e de conformidade de 2023 totalizaram US $ 2,1 milhões, cobrindo os processos de envio da FDA e da EMA.

Categoria de conformidade	Despesa
Custos de envio da FDA	US $ 1,3 milhão
Taxas regulatórias da EMA	US $ 0,8 milhão

Manutenção da propriedade intelectual

As despesas anuais de manutenção da propriedade intelectual foram de US $ 1,5 milhão em 2023.

• Custos de arquivamento de patentes e renovação: US $ 0,9 milhão
• Despesas de proteção legal: US $ 0,6 milhão

Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negócios: fluxos de receita

Potenciais acordos futuros de licenciamento de medicamentos

A partir de 2024, a Galmed Pharmaceuticals possui uma receita potencial de licenciamento associada ao seu candidato a medicamentos Aramchol para Nash (esteato-hepatite não alcoólica).

Potencial parceiro de licenciamento	Pagamentos potenciais estimados em potencial	Faixa de royalties potenciais
Empresa farmacêutica não divulgada	US $ 50 milhões - US $ 100 milhões	7% - 12% das vendas líquidas

Financiamento de pesquisa colaborativa

Galmed garantiu financiamento de colaboração de pesquisa de várias fontes.

Fonte de financiamento	Quantidade total de financiamento	Foco na pesquisa
Institutos Nacionais de Saúde (NIH)	US $ 2,3 milhões	Nash Research

Potenciais receitas de parceria farmacêutica

As receitas potenciais de parceria são estruturadas em torno do desenvolvimento da Aramchol.

• Podendo o pagamento da parceria inicial: US $ 25 milhões - US $ 40 milhões
• Possibilidade de desenvolvimento potencial de desenvolvimento: até US $ 250 milhões
• Possibilidades comerciais em potencial: até US $ 300 milhões

Futura comercialização terapêutica de produtos

Receita projetada flui de potencial comercialização da Aramchol.

Segmento de mercado	Potencial estimado de receita anual	Projeção de penetração no mercado
NASH MERCADO DE TRATAMENTO	US $ 150 milhões - US $ 250 milhões	2% - 5% participação de mercado até 2026

Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Value Propositions

You're looking at the core value Galmed Pharmaceuticals Ltd. (GLMD) offers to patients and the healthcare system, centered around its lead compound, Aramchol, and its next-generation formulation, Aramchol Meglumine.

Offering a potential first-in-class oral therapy for MASH (Metabolic dysfunction-associated Steatohepatitis).

Galmed Pharmaceuticals Ltd. is positioning Aramchol as a leading candidate in the MASH space, building on a deep clinical history. The original Aramchol acid has already been advanced through six clinical trials, including a Phase 3 study, enrolling 661 patients, which established its safety and efficacy for treating NASH (MASH) under the IND 505(b)1 regulatory pathway. Furthermore, Galmed Pharmaceuticals Ltd. secured a new Use Patent in South Korea for a combination therapy involving Aramchol and Madrigal Pharmaceuticals' Rezdiffra for MASH and liver fibrosis, extending protection worldwide until July 2042.

Providing a safe, well-tolerated drug candidate ideal for MASH combination therapies.

A key value component is the established safety profile. Aramchol successfully demonstrated overall excellent tolerability and safety across those prior trials. This profile is critical because Galmed Pharmaceuticals Ltd. believes the optimum treatment for MASH will be combination therapy. The company is actively pursuing combination studies, underscored by the recent patent grant covering Aramchol's combination with Rezdiffra for MASH treatment.

Developing a multi-system therapeutic with potential for cardiometabolic and oncology applications.

The value proposition extends beyond the liver. Biomarker analysis from the Phase 3 ARMOR study, using a 70-Protein Pharmacodynamic (PD) Signature identified in collaboration with Proteas Health, pointed to multi-system effects. Specifically, this analysis showed a validated decrease in ANP (Atrial Natriuretic Peptide), a key clinical marker for heart failure, highlighting expansion potential into broader cardiometabolic markets. Also, Galmed Pharmaceuticals Ltd. is actively seeking to advance Aramchol for oncological indications outside of MASH and fibrosis. On November 17, 2025, Galmed Pharmaceuticals Ltd. announced that a 3-drug combination of Aramchol, Stivarga®, and Metformin significantly enhanced gastrointestinal tumor cell killing in-vivo and in-vitro.

Improving patient adherence with a new, considerably higher bioavailability, once-daily regimen.

The transition to Aramchol Meglumine, a New Chemical Entity (NCE) patented until 2035, delivers a major patient benefit through improved pharmacokinetics. The Phase 1 AM-001 bioavailability study compared the new granules to the old 300 mg tablets. This enhanced formulation is expected to improve long-term adherence by supporting a once-daily regimen. The data from the 30 healthy volunteers in the AM-001 study clearly supports this shift:

Aramchol Meglumine Dose	Relative Bioavailability vs. Aramchol Free Acid 300 mg Tablets
400 mg Granules	Approximately 5-fold greater
200 mg Granules	Approximately 3-fold greater

This improved exposure profile also carries a financial value proposition, as Galmed Pharmaceuticals Ltd. projects the new formulation could reduce the drug cost of goods by approximately ~50%.

Targeting high-unmet-need diseases like advanced liver fibrosis and GI cancers.

The focus is squarely on areas with significant unmet need. For MASH, the Phase 3 ARMOR open-label results showed fibrosis improvement at week 48 in 65% of paired subjects and 100% using AI analysis. In oncology, the target is reversing drug resistance in GI cancers, such as advanced colorectal and liver cancers, where most patients receiving tyrosine kinase inhibitors (TKIs) develop resistance within 6 months of treatment. Galmed Pharmaceuticals Ltd. plans to advance Aramchol Meglumine into upcoming oncology Phase 2 studies by H1 2026.

Financially, the company is managing development with discipline; as of September 30, 2025, cash and equivalents totaled approximately $19.2 million, following approximately $9.3 million raised during 2025.

Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Customer Relationships

You're hiring before product-market fit, so your relationships with key scientific and financial stakeholders are everything right now. Galmed Pharmaceuticals Ltd. focuses its customer relationship strategy on three core groups: the clinical/academic community, the investment base, and potential future commercial partners.

High-touch, direct engagement with key opinion leaders and clinical investigators

Galmed Pharmaceuticals Ltd. maintains direct relationships to validate its lead compound, Aramchol, across its expanding indications. This engagement is critical for advancing its oncology pipeline, which is a newer focus area outside of liver disease.

• Planned Phase 1/2 oncology trial with VCU Massey Comprehensive Cancer Center targeted for early 2026.
• Preclinical data showed Aramchol enhanced Bayer's Stivarga® effect in GI cancer models, announced November 17, 2025.
• The company is developing Amilo-5MER through a research collaboration with the Hebrew University of Jerusalem, where its first-in-human Phase 1 trial assessing safety, tolerability, and pharmacokinetics is ongoing.

Investor relations and communication to maintain confidence during the clinical-stage phase

Maintaining investor confidence is paramount for a clinical-stage company. Communication centers on financial runway, clinical progress, and intellectual property protection. The company filed its Annual Report on Form 20-F for the fiscal year ended December 31, 2024, on April 2, 2025.

Here's the quick math on the current financial position as of late 2025:

Metric	Amount/Value	Date/Period
Cash Position (Q3 2025)	Approximately $19.2 million	September 30, 2025
Quarterly Operating Burn Rate	Approximately $1.5 million per quarter	Year-to-date 2025
Net Loss (Q3 2025)	Approximately $2.0 million	Three months ended September 30, 2025
R&D Expenses (Q3 2025)	Approximately $1.1 million	Three months ended September 30, 2025
Market Capitalization	$5.86 million	As of latest close (early December 2025)
Share Price (Latest Close)	$1.07	As of latest close (early December 2025)

The Annual General Meeting of Shareholders was held on October 28, 2025. What this estimate hides is the dependency on future financing events to extend the runway past the current cash position less the burn rate.

Collaborative research relationships with academic centers for pre-clinical and clinical studies

Galmed Pharmaceuticals Ltd. actively partners with academic institutions to leverage specialized research capabilities and accelerate development methodologies, including AI data mining and proprietary systems. These relationships are key to expanding Aramchol's utility.

• Collaboration with Virginia Commonwealth University (VCU) announced results on November 17, 2025, regarding Aramchol overcoming drug resistance in GI cancers.
• The company is also collaborating with the Hebrew University on the development of Amilo-5MER.
• The Phase 3 ARMOR open-label study showed fibrosis improvement at week 48: 65% (paired) and 100% (AI).

Future commercial licensing negotiations with major pharmaceutical companies

The strategy involves securing IP protection and demonstrating synergistic effects to attract major partners for commercialization, especially for combination therapies. The company is exploring opportunities to expand and diversify its product pipeline.

Key data points related to potential future commercial relationships include:

• New Use Patent granted in South Korea on December 4, 2025, for Aramchol in combination with Madrigal Pharmaceuticals' Rezdiffra (resmetirom) for MASH and fibrosis.
• This patent extends protection for the combination therapy until July 2042.
• The combination with Stivarga® is expected to enter phase 1b clinical trials early 2026.
• A previously announced binding term sheet for a SEDDS formulation license with Entomus s.r.o. was terminated in August 2025.

Finance: draft 13-week cash view by Friday.

Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Channels

You're looking at how Galmed Pharmaceuticals Ltd. gets its science and potential products to the next stage, which right now is heavily weighted toward research execution and securing capital to fund that execution. The channels aren't about selling pills yet; they are about running trials and raising money.

Global network of Contract Research Organizations (CROs) for clinical trial execution

Galmed Pharmaceuticals Ltd. relies on Contract Research Organizations (CROs) to manage the execution of its clinical trials, tailoring the choice of CRO based on the specific requirements of the drug candidate in development, such as Aramchol or Amilo-5MER.

When clinical research is overseen by these CROs, compliance with federal regulations is a key operational channel requirement. This includes adherence to:

• 21 C.F.R. parts 50 (Informed Consent)
• 21 C.F.R. parts 54 (Financial Conflicts of Interest by Investigators)
• 21 C.F.R. parts 56 (Institutional Review Boards or IRBs)
• 21 C.F.R. parts 58 (Good Laboratory Practices)
• 21 C.F.R. part 312 (Investigational New Drug Applications)

Academic and institutional research centers (e.g., VCU) for early-stage discovery and trials

The connection to academic centers is a vital channel for advancing early-stage data, particularly in novel indications like oncology. Galmed Pharmaceuticals Ltd. actively uses these collaborations to generate proof-of-concept data to support future development pathways.

Key activity with Virginia Commonwealth University (VCU) in 2025 included:

Event/Agreement	Date Reference	Financial/Statistical Data Point
Sponsored Project Agreement Launch	April 17, 2025	Evaluation of Aramchol\'s effect on overcoming drug resistance in GI Cancers
Top-Line Results Announcement (Joint Research)	November 17, 2025	Showed a 3-drug combination of Aramchol, Stivarga®, and Metformin significantly enhanced gastrointestinal tumor cells killing in-vivo and in-vitro
Future Clinical Trial Plan (Early 2026)	As of December 2025 Letter	Phase 1/2 trial for metastatic colorectal cancer (CRC), hepatocellular carcinoma (HCC), and cholangiocarcinoma planned in collaboration with VCU Massey Comprehensive Cancer Center

The Research and development expenses for Galmed Pharmaceuticals Ltd. in the third quarter ended September 30, 2025, were approximately $1.1 million, an increase from approximately $0.7 million for the same period in 2024, primarily resulting from clinical and pre-clinical studies expenses.

Future out-licensing agreements with pharmaceutical partners for commercialization and distribution

While Galmed Pharmaceuticals Ltd. is currently focused on advancing Aramchol for oncological indications outside of NASH and fibrosis, the path to commercialization channels involves potential out-licensing. However, recent activity shows a modification of a planned deal structure.

In August 2025, Galmed Pharmaceuticals Ltd. terminated a binding term sheet with Entomus s.r.o. for an exclusive license to commercialize a Self-Emulsifying Drug Delivery System (SEDDS) formulation. Instead, a new UK-based company was established by the CEO, where Galmed Pharmaceuticals Ltd. is contemplating acquiring up to a 20% stake.

At-the-Market (ATM) and equity facilities for capital raising from investors

Financing the clinical development pipeline is a critical channel for Galmed Pharmaceuticals Ltd. The company actively uses its equity facilities to supplement its cash position.

Key capital raising metrics for 2025:

• Total raised through equity line and ATM facilities during 2025 was approximately $9.3 million (as of Q3 2025 report).
• The company raised $6.5 million since the beginning of 2025 (as of Q1 2025 report).
• As of September 30, 2025, cash and cash equivalents, short term deposits, and marketable debt securities totaled approximately $19.2 million.
• The Board approved an amendment on August 15, 2025, increasing authorized share capital from 50,000,000 ordinary shares to 900,000,000.
• Ordinary shares outstanding increased to 5,479,231 as of September 30, 2025, driven by equity issuance.

The company's burn rate was minimal, approximately $1.5M per quarter since the beginning of the year, as stated in the December 2025 Letter to Shareholders.

Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Customer Segments

Galmed Pharmaceuticals Ltd. targets distinct patient populations for its lead compound, Aramchol, and its pipeline candidates, alongside the capital providers necessary to fund its clinical-stage development.

The primary patient segment centers on those afflicted with Metabolic Dysfunction-Associated Steatohepatitis (MASH), formerly known as NASH, and associated liver fibrosis. The Phase 3 ARMOR trial was designed to enroll approximately 2,000 NASH patients with stage 2 and 3 liver fibrosis. The Open-Label Part of this study involved 150 subjects confirmed with NASH and fibrosis stages F1-F3. To date, Aramchol has been advanced through six clinical trials, including up to Phase 3, enrolling a total of 661 patients for NASH/MASH treatment.

The company also targets oncology patients, specifically those with Gastrointestinal (GI) cancers. This segment is being addressed through research collaborations, such as the one with Virginia Commonwealth University (VCU), which reported on November 17, 2025, that a 3-drug combination involving Aramchol significantly enhanced the killing of GI tumor cells in-vivo and in-vitro. Galmed Pharmaceuticals Ltd. plans to advance this program with a Phase 1/2 oncology trial with VCU in early 2026.

The Amilo-5MER program targets patients with chronic inflammatory diseases, such as ulcerative colitis. Specific patient enrollment or market size data for this program was not detailed in recent financial updates.

The final critical customer segment comprises the financial providers who sustain Galmed Pharmaceuticals Ltd.'s operations, given its clinical-stage status and lack of product revenue.

Here's a look at the capital structure and financing activity as of late 2025:

Financial Metric	Value/Percentage	Date/Period	Source Reference
Institutional Ownership Percentage	76.14%	2025
Cash and Equivalents, Deposits, Debt Securities (Current Assets)	$19.7 million	September 30, 2025
Closing Cash Position (CEO Letter)	Approx. $19.2 million	End of Q3 2025
Equity Raised (ATM/Standby Agreements)	Approx. $7.8 million	First nine months of 2025
Equity Raised (May 2025)	Additional $5.0 million	May 2025
Reported Operating Burn	Approx. $1.5M per quarter	Year-to-date 2025
Net Loss (Q3 2025)	Approx. $2.0 million	Q3 2025

The reliance on external funding is clear, as management stated significant additional capital will be needed to advance the pipeline. The company is actively managing its capital through equity issuance, which increased ordinary shares outstanding to 5,479,231 as of September 30, 2025.

Key characteristics of the investor segment include:

• Institutional investors hold 76.14% of the stock.
• Recent institutional buyers included Citadel Advisors LLC (purchased $50.49K worth in last 24 months).
• The company has a stated plan to allocate up to 50% of cash reserves into cryptocurrencies like Bitcoin and Ethereum.
• The stock has a 52-week range as of early December 2025 between a low of $0.74 and a high of $3.61.
• The stock price on December 4, 2025, was $1.13.

Finance: review cash runway based on $1.5M quarterly burn against $19.2M cash by end of next week.

Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Cost Structure

The Cost Structure for Galmed Pharmaceuticals Ltd. is heavily weighted toward research and development activities, typical for a clinical-stage biopharmaceutical entity. You see this reflected in the quarterly operating expenses, which management has kept disciplined relative to the cash position.

Here's a quick look at the reported operating expenses for the third quarter ended September 30, 2025:

Expense Category	Q3 2025 Amount (USD)	Comparison to Q3 2024 (USD)
Research and Development (R&D) Expenses	$1.1 million	Increased from approximately $0.7 million
General and Administrative (G&A) Expenses	$1.0 million	Decreased from approximately $1.3 million
Net Loss (Total Operating Expense Proxy)	Approximately $2.0 million	Up from approximately $1.9 million

The company has maintained a consistent operational outlay throughout 2025, which you can track through the cash burn rate. This rate is a critical metric for managing runway.

• High cash burn rate, approximately $1.5 million per quarter year-to-date 2025.

The R&D spend is directly tied to advancing the pipeline, which is the primary cost driver. This includes significant outlay for ongoing studies of Aramchol.

• Costs associated with clinical trial operations and manufacturing of drug candidates, with the increase in Q3 2025 R&D expenses resulting primarily from clinical and pre-clinical studies expenses.

Furthermore, Galmed Pharmaceuticals Ltd. has introduced a new strategic cost consideration related to its treasury management, though these are planned investments rather than operational expenses in the traditional sense.

• Investment costs related to the new digital asset management strategy, which contemplates an initial allocation of up to $10 million, representing approximately 50% of the cash reserves at the time of the August 2025 announcement.

Finance: draft 13-week cash view by Friday.

Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Galmed Pharmaceuticals Ltd. (GLMD) as of late 2025. For a clinical-stage biotech, revenue streams are often lumpy, relying heavily on non-operational financing and future deal structures rather than product sales.

Here is a snapshot of the realized and potential revenue components based on the latest available data through the third quarter of 2025.

Revenue Source Category	Period/Status	Reported Amount
Proceeds from Equity Financing	Year-to-Date 2025	$9.3 million
Financial Income, Net	Q3 2025 (Three Months Ended September 30)	$0.2 million
Cash Reserves Balance (for context)	September 30, 2025	$19.2 million

The primary realized cash inflow during 2025 has been from capital markets activities, which is typical for a company advancing a lead asset like Aramchol through late-stage trials.

Future revenue potential is tied to the success of Aramchol and strategic treasury management.

• Future potential milestone payments and upfront fees from licensing agreements for Aramchol.
• Potential yield generation from the new digital asset treasury strategy.

Regarding the licensing potential, Galmed Pharmaceuticals Ltd. is actively pursuing opportunities to expand Aramchol's use beyond NASH and fibrosis into oncological and cardiometabolic indications. While a Term Sheet for a Semaglutide formulation was announced, definitive upfront fees or milestone payments related to Aramchol licensing were not reported as realized revenue for the period ending September 30, 2025. The company is focused on advancing Aramchol Meglumine into Phase 2 oncology studies planned for H1 2026.

The digital asset strategy, adopted in August 2025, is a forward-looking revenue/yield component. The board established a Crypto Committee to evaluate an allocation of up to 50% of the Company's cash reserves, which was approximately $10 million as of August 2025, into digital assets. However, as of the Q3 2025 reporting, no such allocation had yet been implemented, meaning the yield generation is purely potential at this point. This strategy aims to deploy capital into active management including covered call options, staking, lending, and yield-generating protocols. Finance: finalize the projected yield range based on the 50% allocation scenario by end of January 2026.