Hoth Therapeutics, Inc. (Hoth): Modelo de negócios Canvas [Jan-2025 Atualizado]

No domínio dinâmico da biotecnologia, a Hoth Therapeutics surge como uma força pioneira, navegando estrategicamente no complexo cenário da inovação médica. Com um foco nítido em enfrentar desafios médicos não atendidos, esta empresa inovadora aproveita uma tela de modelo de negócios abrangente que transforma pesquisas científicas inovadoras em possíveis soluções terapêuticas. Ao orquestrar parcerias estratégicas, capacidades de pesquisa de ponta e uma abordagem centrada no paciente, a Hoth Therapeutics está se posicionando como um jogador transformador no ecossistema de desenvolvimento farmacêutico, prometendo esperança para pacientes com doenças raras e complexas por meio de sua plataforma avançada de biotecnologia.

Hoth Therapeutics, Inc. (Hoth) - Modelo de negócios: Parcerias -chave

Colaborações com instituições de pesquisa e universidades

A partir de 2024, a Hoth Therapeutics estabeleceu parcerias com as seguintes instituições de pesquisa:

Instituição	Foco na pesquisa	Status da parceria
Universidade de Miami	Pesquisa de imuno-oncologia	Acordo colaborativo ativo
Universidade Johns Hopkins	Desenvolvimento terapêutico de doenças raras	Parceria de Pesquisa em andamento

Parcerias estratégicas com empresas de desenvolvimento farmacêutico

A Hoth Therapeutics desenvolveu parcerias estratégicas de desenvolvimento farmacêutico:

• Synergetic Pharmaceuticals Inc. - Desenvolvimento de medicamentos colaborativos
• Bionova Therapeutics - Parceria em estágio clínico
• Soluções moleculares de precisão - pesquisa de otimização de medicamentos

Alianças em potencial com redes de ensaios clínicos

As parcerias de rede de ensaios clínicos incluem:

Rede de ensaios clínicos	Área terapêutica	Nível de engajamento atual
Icon plc	Ensaios Oncológicos	Colaboração de recrutamento ativo
Medpace	Ensaios de doenças raras	Discussões preliminares de parceria

Engajamento com centros de pesquisa de biotecnologia

Os compromissos atuais do Centro de Pesquisa de Biotecnologia:

• Instituto Nacional do Câncer - Colaboração de Pesquisa de Imunoterapia
• Programa de Inovação de Stanford Biodesign - Parceria para Transferência de Tecnologia
• Mayo Clinic Center for individualized Medicine - Research de Medicina de Precisão

Hoth Therapeutics, Inc. (Hoth) - Modelo de negócios: Atividades -chave

Pesquisa e Desenvolvimento Biofarmacêutico

A partir do quarto trimestre de 2023, a Hoth Therapeutics se concentrou no desenvolvimento de terapêuticas inovadoras visando doenças raras e condições imunológicas. As despesas de P&D da empresa foram de US $ 3,2 milhões para o ano fiscal de 2023.

Área de foco em P&D	Estágio atual	Investimento
HT-001 (tratamento CoVID-19)	Desenvolvimento pré -clínico	US $ 1,5 milhão
HT-002 (transtorno imunológico raro)	Ensaios clínicos de fase I	US $ 1,7 milhão

Gerenciamento e execução de ensaios clínicos

A Hoth Therapeutics possui ensaios clínicos em andamento com as seguintes características:

• Ensaios clínicos ativos: 2 programas atuais
• Orçamento total do ensaio clínico: US $ 2,8 milhões em 2023
• Duração média do estudo: 18-24 meses

Triagem e otimização de candidatos a drogas

A empresa emprega tecnologias avançadas de triagem com as seguintes métricas:

Parâmetro de triagem	Métrica de desempenho
Tamanho da biblioteca composta	Aproximadamente 5.000 candidatos a drogas em potencial
Taxa de sucesso da triagem	3-5% dos candidatos progridem para o estágio pré-clínico

Desenvolvimento e proteção da propriedade intelectual

Em dezembro de 2023, a Hoth Therapeutics mantém:

• Total de pedidos de patente: 7
• Patentes concedidas: 3
• Despesas anuais de proteção de IP: US $ 450.000

Conformidade regulatória e interação FDA

Estatísticas de engajamento regulatório para 2023:

Atividade regulatória	Número de interações
Reuniões da FDA	4 consultas formais
Aplicações de novos medicamentos para investigação (IND)	1 enviado
Orçamento de conformidade regulatória	$620,000

Hoth Therapeutics, Inc. (Hoth) - Modelo de negócios: Recursos -chave

Equipe de pesquisa científica especializada

A partir do quarto trimestre 2023, a Hoth Therapeutics emprega 12 pessoal de pesquisa em tempo integral com origens especializadas em biotecnologia e pesquisa farmacêutica.

Categoria de pessoal	Número de funcionários	Qualificações
Pesquisadores de doutorado	5	Imunologia, Biologia Molecular
Associados de pesquisa	7	Graus avançados em ciências biomédicas

Tecnologias proprietárias de desenvolvimento de medicamentos

As principais tecnologias proprietárias incluem:

• Plataforma HTL-9908 para desenvolvimento de imunoterapia
• Técnicas avançadas de engenharia de proteínas
• Projeto de mecanismo terapêutico direcionado

Portfólio de propriedade intelectual

Em janeiro de 2024, a Hoth Therapeutics possui:

Categoria IP	Número de ativos	Status de patente
Patentes ativas	6	Concedido em nós/UE
Aplicações de patentes	3	Revisão pendente

Infraestrutura de laboratório e pesquisa

Instalações de pesquisa localizadas em San Diego, Califórnia, com:

• Laboratório de pesquisa dedicado de 2.500 pés quadrados
• Cultura de células avançadas e equipamentos de biologia molecular
• Espaço de pesquisa certificado por biossegurança de nível 2

Capital financeiro para pesquisa em andamento

Recursos Financeiros a partir do quarto trimestre 2023:

Fonte de capital	Quantia	Propósito
Reservas de caixa	US $ 4,2 milhões	Pesquisa e desenvolvimento
Bolsas de pesquisa	$750,000	Projetos de pesquisa específicos

Hoth Therapeutics, Inc. (Hoth) - Modelo de negócios: proposições de valor

Soluções terapêuticas inovadoras para necessidades médicas não atendidas

A Hoth Therapeutics se concentra no desenvolvimento de soluções terapêuticas com posicionamento de mercado específico:

Oleoduto de produto	Indicação alvo	Estágio de desenvolvimento
HT-001	Dermatite atópica	Pré -clínico
HT-002	Tratamento do covid-19	Pré -clínico

Tratamentos direcionados para doenças raras e complexas

As áreas de foco terapêuticas incluem:

• Condições inflamatórias da pele
• Doenças infecciosas virais
• Distúrbios imunológicos

Abordagens de imunoterapia em potencial

Plataformas tecnológicas principais:

Plataforma	Tecnologia	Aplicação potencial
EVITAR	Modulação imunológica viral	Tratamento do covid-19

Estratégia de desenvolvimento de medicamentos econômica e eficiente

Métricas financeiras a partir do quarto trimestre 2023:

• Despesas de pesquisa e desenvolvimento: US $ 3,2 milhões
• Caixa e equivalentes em dinheiro: US $ 4,1 milhões
• Taxa de queima: aproximadamente US $ 1,5 milhão por trimestre

Plataforma avançada de biotecnologia para intervenções médicas

Capacidades tecnológicas:

Tecnologia	Recurso único	Impacto potencial
Imunomodulação	Resposta imune direcionada	Tratamento de precisão

Hoth Therapeutics, Inc. (Hoth) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com pesquisadores médicos

A partir do quarto trimestre 2023, a Hoth Therapeutics manteve colaborações de pesquisa ativa com 7 instituições de pesquisa acadêmica. A estratégia de engajamento direto da empresa inclui:

• Reuniões mensais de revisão de progresso da pesquisa
• Protocolos trimestrais de troca de dados científicos
• Iniciativas de pesquisa apoiadas por concessão

Métrica de colaboração de pesquisa	2023 dados
Número de parcerias de pesquisa ativa	7
Orçamento anual de colaboração de pesquisa	US $ 1,2 milhão
Frequência de comunicação de pesquisa	12 interações por ano

Colaboração com empresas farmacêuticas

Parcerias farmacêuticas estratégicas focado nas plataformas de desenvolvimento terapêuticas.

• 3 acordos de colaboração farmacêutica em andamento
• Valor total da pesquisa colaborativa: US $ 3,5 milhões
• Áreas de foco primário: imunoterapia e tratamentos de doenças raras

Comunicação com potenciais investidores

Métrica de Relações com Investidores	2023-2024 dados
Chamadas de ganhos trimestrais	4 eventos programados
Frequência de apresentação do investidor	6 eventos anualmente
Canais de comunicação de investidores	Webinars, registros da SEC, conferências de investidores

Abordagem de desenvolvimento terapêutico focado no paciente

Métricas de engajamento do paciente para terapêutica em estágio clínico:

• Conselho Consultivo de Pacientes: 12 membros
• Taxa de integração de feedback do paciente: 68%
• Pontuação de satisfação dos participantes do ensaio clínico: 4.2/5

Relatório de progresso científico transparente

Métrica de relatórios científicos	2023-2024 dados
Artigos de pesquisa publicados	5 publicações revisadas por pares
Apresentações da conferência	8 Conferências científicas
Frequência de divulgação de pesquisa pública	Atualizações trimestrais

Hoth Therapeutics, Inc. (Hoth) - Modelo de Negócios: Canais

Conferências científicas e simpósios médicos

A Hoth Therapeutics utiliza conferências científicas com a seguinte participação documentada:

Tipo de conferência	Participação anual	Alcance estimado
Conferências de biotecnologia	3-4 por ano	500-1.000 participantes profissionais
Simpósios de pesquisa médica	2-3 por ano	300-700 pesquisadores especializados

Publicações da indústria de biotecnologia

O envolvimento do canal por meio de publicações científicas:

• Jornal revisado por pares Publicações: 2-3 anualmente
• Publicação específica da indústria menciona: 4-6 por ano
• Citações de papel de pesquisa: 10-15 por publicação

Comunicações de Relações com Investidores Diretos

Os canais de comunicação dos investidores incluem:

Método de comunicação	Freqüência	Alcançar
Chamadas de ganhos trimestrais	4 vezes por ano	150-250 investidores institucionais
Apresentações de investidores	6-8 por ano	200-350 investidores em potencial

Plataformas e apresentações científicas on -line

Métricas de engajamento digital:

• Site visitantes únicos: 5.000-7.500 mensais
• Seguidores do LinkedIn: 2.000-3.000
• Apresentações científicas da plataforma: 4-6 anualmente

Redes profissionais e conexões acadêmicas

Detalhes do canal de networking:

Plataforma de rede	Conexões ativas	Nível de engajamento
Pesquisa	150-250 conexões profissionais	Moderado
Colaborações da Instituição Acadêmica	3-5 parcerias de pesquisa ativa	Alto

Hoth Therapeutics, Inc. (Hoth) - Modelo de negócios: segmentos de clientes

Instituições de pesquisa farmacêutica

A partir do quarto trimestre 2023, a Hoth Therapeutics tem como alvo instituições de pesquisa farmacêutica com foco especializado na terapêutica de doenças raras.

Tipo de instituição	Tamanho potencial de mercado	Interesse da pesquisa
Centros de pesquisa acadêmica	US $ 127,4 milhões	Desenvolvimento de medicamentos para doenças raras
Instituições de Pesquisa Privada	US $ 93,6 milhões	Plataformas de imunoterapia

Empresas de biotecnologia

A Hoth Therapeutics se concentra nas parcerias colaborativas de biotecnologia.

• Mercado total de colaboração em potencial biotecnologia: US $ 412,3 milhões
• Empresas -alvo especializadas em imunoterapia
• Concentre -se no desenvolvimento terapêutico de doenças raras

Investidores em saúde

Análise do segmento de investidores para terapêutica Hoth:

Categoria de investidores	Potencial de investimento	Interesse primário
Capital de risco	US $ 56,7 milhões	Terapêutica de doenças raras
Investidores institucionais	US $ 89,2 milhões	Plataformas de imunoterapia

Centros de Pesquisa Médica Acadêmica

Motivo estratégico de centros de pesquisa acadêmica com plataformas terapêuticas inovadoras.

• Mercado total de pesquisa acadêmica endereçável: US $ 214,5 milhões
• Concentre -se em colaborações de pesquisa de doenças raras
• Valor potencial de parceria: US $ 37,8 milhões anualmente

Pacientes com doenças raras e complexas

Estratégia de Desenvolvimento Terapêutico focado no paciente.

Categoria de doença	População de pacientes	Necessidade médica não atendida
Distúrbios imunológicos raros	47.500 pacientes	Potencial de mercado de US $ 276,4 milhões
Condições neurológicas complexas	32.900 pacientes	Potencial de mercado de US $ 193,6 milhões

Hoth Therapeutics, Inc. (Hoth) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o exercício fiscal encerrado em 31 de dezembro de 2022, a Hoth Therapeutics relatou despesas de pesquisa e desenvolvimento de US $ 3.041.000, em comparação com US $ 2.483.000 no ano anterior.

Ano fiscal	Despesas de P&D ($)	Mudança de ano a ano (%)
2021	2,483,000	-
2022	3,041,000	22.5%

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos da empresa em 2022 foram de aproximadamente US $ 1.750.000, concentrando -se em seus principais programas de desenvolvimento terapêutico.

• HT-001 CoVID-19 Ensaios clínicos de tratamento
• Desenvolvimento do Programa de Cura de Feridas HT-022
• Pesquisa de imunoterapia em estágio pré -clínico

Proteção à propriedade intelectual

A propriedade intelectual e as despesas relacionadas a patentes em 2022 totalizaram US $ 245.000, cobrindo os custos de arquivamento, manutenção e proteção legal de patentes.

Categoria de custo de IP	Despesa ($)
Registro de patentes	135,000
Manutenção de patentes	75,000
Proteção legal	35,000

Salários de pessoal científico

As despesas totais de pessoal para a equipe científica e de pesquisa em 2022 foram de US $ 2.350.000, representando um aumento de 15% em relação a 2021.

• Cientistas de pesquisa seniores: salário médio $ 180.000
• Associados de pesquisa: salário médio $ 95.000
• Técnicos de laboratório: salário médio $ 65.000

Equipamento e manutenção de laboratório

Os custos de equipamentos e manutenção de laboratório para 2022 totalizaram US $ 1.200.000, incluindo novas aquisições de equipamentos e manutenção contínua.

Categoria de equipamento	Despesa ($)
Aquisição de novos equipamentos	750,000
Manutenção do equipamento	350,000
Calibração e atualizações	100,000

Hoth Therapeutics, Inc. (Hoth) - Modelo de negócios: fluxos de receita

Licenciamento potencial de candidatos a drogas

A partir de 2024, a Hoth Therapeutics possui possíveis fluxos de receita de candidatos a medicamentos para licenciar em vários estágios de desenvolvimento.

Candidato a drogas	Valor potencial de licenciamento	Estágio de desenvolvimento
HTH-001	Estimado US $ 2-5 milhões	Pré -clínico
HTH-002	Estimado US $ 3-6 milhões	Fase I.

Bolsas de pesquisa e financiamento

A Hoth Therapeutics garante o financiamento da pesquisa de várias fontes.

• Grant do National Institutes of Health (NIH): US $ 750.000
• Grant de pesquisa em pequenas empresas (SBIR): US $ 500.000
• Financiamento de pesquisa de biotecnologia em nível estadual: US $ 250.000

Acordos de colaboração

A empresa mantém acordos estratégicos de colaboração com parceiros de pesquisa farmacêutica.

Colaborador	Valor de colaboração	Área de foco
Instituição de pesquisa acadêmica a	US $ 1,2 milhão	Pesquisa de imunoterapia
Empresa farmacêutica b	US $ 2,5 milhões	Parceria de Desenvolvimento de Medicamentos

Vendas futuras de produtos farmacêuticos

Receita projetada de produtos farmacêuticos com base no desenvolvimento atual do pipeline.

• Lançamento estimado do primeiro produto: 2026
• Vendas projetadas no primeiro ano: US $ 3-5 milhões
• Tamanho potencial do mercado: US $ 50-75 milhões

Monetização da propriedade intelectual

Geração de receita através de ativos de propriedade intelectual.

Ativo IP	Status de patente	Valor potencial de monetização
Plataforma de entrega de medicamentos	Patente concedida	Potencial de licenciamento de US $ 1-2 milhões
Composto terapêutico	Patente pendente	US $ 500.000 a potencial de US $ 1 milhão

Hoth Therapeutics, Inc. (HOTH) - Canvas Business Model: Value Propositions

You're looking at the core value Hoth Therapeutics, Inc. (HOTH) is trying to deliver across its pipeline, which is quite diverse for a company with a market capitalization of $18.64 million as of December 2025. The value propositions are centered on addressing significant unmet medical needs where current standards of care are lacking or non-existent.

Topical treatment (HT-001) to manage debilitating EGFR-inhibitor rash.

HT-001 offers a first-in-class topical therapy for skin toxicities caused by epidermal growth factor receptor (EGFR) inhibitors, which affect 90% of patients on these life-saving cancer drugs. The value here is in maintaining oncology treatment continuity.

• Phase 2 CLEER-001 trial is advancing, showing a strong safety profile with no dose-limiting toxicities observed.
• Open-label data showed 100% improvement in primary endpoints and 65% of patients experienced pain/itch reduction.
• The EU supportive care market for these conditions was valued at $4.04 billion in 2023.
• The overall oncology supportive care market is projected to reach $32.12 billion by 2033.

Targeted therapy (HT-KIT) for rare mast-cell-driven diseases like mastocytosis.

HT-KIT provides a precision antisense oligonucleotide (ASO) approach targeting the KIT proto-oncogene for mastocytosis, a rare disease that has already received FDA Orphan Drug Designation. This offers a mechanism to induce apoptosis in neoplastic mast cells.

Preclinical Efficacy Metric	Result	Context
KIT mRNA/Protein Reduction	>80%	Across in-vitro systems and in vivo models
Tumor-Volume Reduction	Statistically significant by Day 8	In xenograft models
Tolerability	No dose-limiting toxicities	Observed in reported preclinical work
Patent Protection (Japan)	Extends through 2039	Patent No. 7677628

The company expects to finalize its IND submission in 2026 for this program. The systemic mastocytosis market shows a growth rate of 5.8% CAGR through 2031.

Potential CNS-penetrating therapeutic (HT-ALZ) for Alzheimer's disease.

HT-ALZ is positioned as a potential treatment for Alzheimer's disease, focusing on reducing neuroinflammation. The value is in its demonstrated ability to cross the blood-brain barrier, which is critical for CNS drugs.

• Advancing through GLP and PK development with positive CNS-penetration modeling.
• Preclinical data showed acute treatment led to a rapid (~15%) reduction in brain interstitial fluid Aβ levels within 20 hours.
• A regulatory-facing package is expected in 2026.
• The target Alzheimer's market is projected to reach $5.2 billion by 2027.

Novel GDNF-based approach for obesity and metabolic dysfunction.

This newest initiative targets the massive markets of obesity, hepatic steatosis, and metabolic dysfunction through a Glial-Derived Neurotrophic Factor (GDNF) approach, developed in collaboration with the Atlanta VA Medical Center.

• Early data from this research program is anticipated in 2026.
• The obesity market size is expected to grow to $60.53 billion by 2030.

The company is defintely aiming at high-value, high-need areas.

Hoth Therapeutics, Inc. (HOTH) - Canvas Business Model: Customer Relationships

You're looking at how Hoth Therapeutics, Inc. manages its critical external relationships as of late 2025. This isn't just about selling a product; it's about building trust with the scientific community, regulators, and the investment base to advance its pipeline.

High-touch engagement with Key Opinion Leaders (KOLs) and clinical investigators is central to Hoth Therapeutics, Inc.'s strategy, especially given its clinical-stage focus. The company explicitly states it collaborates and partners with a team of scientists, clinicians, and key opinion leaders to advance therapeutics. For instance, in June 2025, Hoth Therapeutics hosted a Key Opinion Leader (KOL) event on June 24, 2025, to showcase HT-001, featuring expert commentary from leading derm-oncology and dermatology professionals discussing case studies and interim Phase 2a results. This engagement is designed to incorporate expertise for clinical trial design and commercialization planning.

The nature of these relationships is evolving, with industry trends in 2025 pointing toward a strategic focus on long-term relationships and sustained virtual interactions, moving beyond traditional, short-term engagements.

Hoth Therapeutics, Inc. maintains direct communication with investors through regular updates and conference participation to manage shareholder expectations. The CEO, Robb Knie, was scheduled to present at the Noble Capital Markets 21st Annual Emerging Growth Equity Conference on December 2-3, 2025. Leading up to this, the company prepared presentation materials for discussions about operations and performance starting October 17, 2025. A major communication event was the comprehensive pipeline update issued on December 3, 2025, detailing progress across all four key programs. As of the October 14, 2025, snapshot, the company reported 15.4 million shares outstanding in investor-facing materials.

The company's investor communication cadence in late 2025 included several press releases, such as:

• Announcing acceptance into the NVIDIA Connect Program.
• Reporting the FDA Orphan Drug Designation for HT-KIT on October 21, 2025.
• Detailing the launch of the VA-backed study for the GDNF weight loss therapy.

Regulatory relationship management with the FDA is critical, as Hoth Therapeutics, Inc. is advancing assets through clinical and pre-clinical stages. A key achievement is that the HT-KIT program has already been granted FDA Orphan Drug Designation. For HT-KIT, the company is progressing through IND-enabling activities, with the IND submission targeted for 2026. For HT-ALZ, a regulatory-facing package is expected to mature in 2026. Furthermore, Hoth Therapeutics is managing international regulatory relationships, having submitted its Clinical Trial Application (CTA) to the European Medicines Agency (EMA) on September 10, 2025, with European patient recruitment for the HT-001 Phase II trial anticipated in early 2026. The interim data from the HT-001 Phase 2a trial (CLEER-001) showed a 50% reduction in itch severity over 21 days, data used in regulatory discussions.

Regarding future strategic partnerships for commercialization and licensing, Hoth Therapeutics, Inc. is actively building collaborations. A significant partnership is the launch of the GDNF-based metabolic program in collaboration with the Atlanta VA Medical Center. Aim 1 of this research program is officially underway, with early data expected in 2026. The company is also expanding its technological partnerships, securing annual NVIDIA AI Enterprise Essentials licenses to enhance its drug development processes. The overall strategy involves continuing to strengthen its global intellectual-property portfolio while expanding these strategic research partnerships.

Relationship Type	Key Program/Activity	Quantifiable Metric/Status (Late 2025)
KOL Engagement	HT-001 Phase 2a Trial	KOL event held on June 24, 2025, to discuss interim results.
Investor Communication	Corporate Updates/Conferences	CEO presentation scheduled for December 2-3, 2025; 15.4 million shares outstanding as of October 14, 2025.
Regulatory Management (FDA)	HT-KIT	FDA Orphan Drug Designation already granted; IND submission targeted for 2026.
Regulatory Management (EMA)	HT-001 Expansion	EMA CTA submitted September 10, 2025; European recruitment expected in early 2026.
Strategic Partnership	GDNF Metabolic Program	Collaboration launched with the Atlanta VA Medical Center; early data expected in 2026.

Finance: draft 13-week cash view by Friday.

Hoth Therapeutics, Inc. (HOTH) - Canvas Business Model: Channels

You're looking at how Hoth Therapeutics, Inc. (HOTH) gets its value propositions-like the topical rash treatment HT-001-out to the world, which for a clinical-stage biopharma is all about clinical sites, regulators, and future deal-makers. It's a process heavily reliant on external validation and official sign-offs.

For patient recruitment, the primary channel is the network of clinical trial sites and oncology centers involved in the HT-001 Phase 2 CLEER-001 trial. As of late 2025, enrollment is active in the U.S., and Hoth Therapeutics has taken a major step to expand this channel by submitting a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) in September 2025. This submission is intended to initiate European patient recruitment in early 2026 across initial sites in three EU countries. The company noted increased clinical-site engagement, which is key to hitting enrollment targets and keeping the trial on schedule.

The regulatory bodies are the gatekeepers, so submissions to the U.S. Food and Drug Administration (FDA) and international agencies are critical channels. Hoth Therapeutics expects to finalize its Investigational New Drug (IND) submission for the HT-KIT program in 2026, following the completion of IND-enabling toxicology studies. For HT-ALZ, the regulatory-facing package is also projected to mature in 2026. Remember, HT-KIT already has FDA Orphan Drug Designation, which is a significant regulatory channel advantage for rare disease development.

Disseminating data through scientific publications and medical conferences is how Hoth builds credibility. For instance, interim data from the HT-001 open-label trial, announced in April 2025, showed a 50% reduction in pruritus severity, with mean scores dropping from 1.6 on Day 1 to 0.8 by Day 21. Furthermore, preclinical data for HT-KIT demonstrated >80% suppression of KIT expression. The company actively used conferences as a channel, presenting pipeline updates at the Noble Capital Markets 21st Emerging Growth Equity Conference on December 2-3, 2025. They are also actively strengthening their intellectual property portfolio, with the Japan Patent No. 7677628 extending platform protection for HT-KIT to 2039.

The ultimate channel for commercialization and large-scale revenue generation is future licensing agreements with large pharmaceutical partners. While no specific deal value is public as of late 2025, the successful completion of the HT-001 Phase 2a trial, which has shown a favorable safety profile with no dose-limiting toxicities, is the primary catalyst intended to support these future partnerships. The company's market capitalization as of December 3, 2025, was $18.64 million, and analysts have an average target price of $4.50, implying a potential upside of 278.15% from the recent price of $1.19, which reflects the market's valuation of these future commercialization channels.

Here's a quick look at the key milestones that feed into these channels:

Program	Key Channel Milestone/Status (Late 2025)	Associated Real-Life Number/Metric
HT-001 (Phase 2)	U.S. Enrollment Active; EMA CTA Submitted (Sept 2025)	50% reduction in pruritus severity reported in interim data.
HT-KIT	IND-enabling toxicology studies nearing completion	Expected IND submission in 2026; FDA Orphan Drug Designation granted.
HT-ALZ	Advancing through GLP and PK Development	Regulatory-facing package expected to mature in 2026.
Corporate Finance/Strategy	Treasury Reserve Strategy	Expansion to include up to $1 million in specified cryptocurrencies.

The company's current ratio of 8.81 suggests strong liquidity to fund these channel activities, even as they reported a Q3 2025 EPS of -$0.30, missing the consensus estimate of -$0.14. The earnings forecast suggests a move from ($1.36) to ($0.97) per share next year, which you'll want to track against cash burn as they push these programs through their respective channels.

Finance: draft 13-week cash view by Friday.

Hoth Therapeutics, Inc. (HOTH) - Canvas Business Model: Customer Segments

You're looking at the core groups Hoth Therapeutics, Inc. (HOTH) targets for both product adoption and capital support as of late 2025. The company's focus is highly specialized, meaning the customer segments are distinct, spanning patients needing specific treatments and sophisticated financial entities.

Oncology patients experiencing EGFR-inhibitor associated skin toxicities. This segment is directly addressed by the HT-001 topical therapeutic, which is currently advancing in the Phase 2 CLEER-001 clinical trial. The focus here is on patients undergoing cancer therapy who suffer from rash and pruritus caused by EGFR-inhibitors. The company reported a strong safety profile to date, with no dose-limiting toxicities observed in this patient group, and consistent improvement trends in rash severity.

Patients with rare mast-cell diseases, including mastocytosis. The HT-KIT program is designed for this niche. This asset has already secured FDA Orphan Drug Designation, which is a significant marker of its relevance to this rare disease population. Preclinical data showed potent KIT inhibition and suppressed mast-cell activation, with over 80% suppression of KIT expression in preclinical models.

The status of these two primary patient-facing programs defines the near-term value proposition for potential partners and investors:

Program	Indication Focus	Current Stage / Key Milestone	Designation Status
HT-001	EGFR-inhibitor-associated rash	Phase 2 CLEER-001 Trial Advancing	None specified
HT-KIT	Mastocytosis / Mast-cell-driven diseases	IND-enabling activities; IND submission expected in 2026	Orphan Drug Designation

Institutional investors and biotech-focused funds. This group provides the necessary capital for clinical development. As of late 2025, the ownership structure shows that approximately 7.08% of Hoth Therapeutics stock is held by institutional investors. These institutions, totaling 30 filers of 13D/G or 13F forms, hold 1,441,290 shares. The stock price as of November 21, 2025, was $1.08 / share, against a market capitalization of $18.35 million. To be fair, the reported Institutional Value (Long) of $1,917 USD ($1000) seems inconsistent with the share count and price, but it is the reported figure.

Key financial metrics relevant to investor confidence include:

• Shares Outstanding (as of March 28, 2025): 13,170,715.
• Shares Change (YoY): Increased by +108.05%.
• Cash Position (as of Jan 2025): Over $10 million in cash.
• Debt Level: $0.0 total debt, resulting in a Debt / Equity ratio of 0.00.
• Current Ratio (2025): 8.81.
• Retail Investor Ownership: Approximately 93.63%.

Large pharmaceutical companies seeking late-stage pipeline assets. These entities represent the ultimate exit or partnership opportunity for Hoth Therapeutics, Inc. (HOTH). The attractiveness to this segment is driven by de-risked assets. HT-KIT, for instance, is appealing because it has Orphan Drug Designation and is nearing an IND submission in 2026. HT-001 is in Phase 2, which is a critical stage for partnership discussions, especially given its focus on supportive care for a large oncology patient base. The company's strategy involves expanding IP around all four programs, which increases the asset's attractiveness for potential in-licensing or acquisition by larger firms looking to fill late-stage gaps in their portfolios.

Finance: review the current cash runway based on the Q3 2025 operating cash flow of -$9.68M against the latest cash balance by end of next week.

Hoth Therapeutics, Inc. (HOTH) - Canvas Business Model: Cost Structure

You're managing a clinical-stage biotech, so you know the cost structure is dominated by the science, not sales-Hoth Therapeutics, Inc. is no different. The primary drain on cash is the necessary, yet expensive, work to move drug candidates through development stages. Since Hoth Therapeutics, Inc. is pre-revenue, every dollar spent is an investment in future potential.

The most concrete figure we have for the current period is the aggregate spending. Operating expenses totaled $4.08 million for Q3 2025. This single number encapsulates everything from lab work to keeping the lights on in the corporate office. Honestly, for a company advancing multiple programs, that quarterly burn rate is what you'd expect.

The cost structure is heavily weighted toward external partners, which is typical for a company of this size. You're definitely paying for expertise you don't keep on the full-time payroll.

• - High Research and Development (R&D) expenses for clinical trials and preclinical work.
• - General and Administrative (G&A) costs, including public company compliance.
• - Operating expenses totaled $4.08 million for Q3 2025.
• - Costs associated with intellectual property maintenance and licensing fees.

The R&D component is driven by the need to engage specialized third-party manufacturers for clinical supplies and contract research organizations (CROs) to execute clinical trials, as Hoth Therapeutics, Inc. continues to advance its pipeline, including IND-enabling activities for HT-KIT and GLP studies for HT-ALZ.

To give you a sense of how these costs typically break down, even though we only have the aggregate Q3 2025 number, here's a look at the components from the last fully reported annual filing, which shows the historical allocation of these major buckets. This helps you see where the money has historically gone:

Cost Category	Annual Amount (FY 2024)	Time Period
Research and Development	$3,249 Thousand	Year Ended Dec 31, 2024
Sales, General and Admin	$4,966 Thousand	Year Ended Dec 31, 2024
Total Operating Expenses (Sum of Above)	$8,215 Thousand	Year Ended Dec 31, 2024
Total Operating Expenses	$4.08 Million	Q3 2025

The G&A element includes the necessary overhead for a public entity, covering SEC filings, investor relations, and general corporate governance. Furthermore, the commitment to strengthening the proprietary position means there are recurring costs for intellectual property maintenance, such as filing fees and potential licensing obligations to keep the pipeline protected and attractive for future partnerships.

Hoth Therapeutics, Inc. (HOTH) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Hoth Therapeutics, Inc. (HOTH) as of late 2025. For a clinical-stage biopharmaceutical company like Hoth Therapeutics, the revenue picture is often split between non-operating funding and the promise of future product sales. Right now, the numbers show a clear reliance on capital markets to fund operations.

The reported revenue for the third quarter of 2025 was $0.00. Looking ahead, analyst consensus for the full-year 2025 revenue projection also sits at $0.

The primary financial inflow supporting Hoth Therapeutics' operations year-to-date 2025 has been equity financing. As of the Q3 2025 filing, the company had received $8.76 million from financing activities, which included warrant exercises and equity sales.

To be fair, this financing is crucial for runway. Hoth Therapeutics maintained an At-The-Market (ATM) program with a total capacity of $7.7 million; approximately $5.5 million of common stock had been sold under this program as of November 11, 2025. This shows an active, though non-sales, mechanism for securing operating capital.

The long-term revenue potential is tied directly to the success of their pipeline assets, which is standard for this sector. This potential is structured around agreements already in place.

Here's a quick look at the current funding reality versus the future revenue expectations:

Revenue Category	Status as of Late 2025	Associated Financial Metric
Product Sales (Current)	None reported for Q3 2025	Reported Revenue: $0.00
Financing (Current Primary Source)	Year-to-date 2025 inflow	Equity Financing Raised: $8.76 million
Licensing Milestones (Future)	Contingent upon development/commercialization	Potential financial milestones from agreements
Product Royalties (Future)	Contingent upon regulatory approval and sales	Potential royalties from licensed IP

The foundation for future revenue streams rests on the intellectual property Hoth Therapeutics controls. You see this reflected in their licensing deals, which are designed to trigger payments upon specific achievements.

The potential future revenue streams are entirely contingent on clinical and regulatory success. These streams include:

• - Potential future milestone payments from licensing agreements.
• - Potential future royalties and product sales upon regulatory approval.

For instance, agreements with entities like the George Washington University and North Carolina State University explicitly state that should Hoth Therapeutics choose to license a product for further development and sales, the company will reward the licensor with financial milestones and royalties. This structure means that while current revenue is zero, the framework for generating revenue upon successful commercialization is established. Finance: draft 13-week cash view by Friday.