Protagenic Therapeutics, Inc. (PTIX): Modelo de Negócios Canvas [Jan-2025 Atualizado]

A Protagenic Therapeutics, Inc. (PTIX) fica na vanguarda da pesquisa inovadora de transtornos neurológicos, pioneiros tecnologias inovadoras de direcionamento molecular que podem revolucionar o tratamento para condições neurológicas complexas. Com seu composto de medicamentos PTI-125 proprietário e uma abordagem estratégica para atender às necessidades médicas não atendidas, esta empresa de biotecnologia está pronta para potencialmente transformar a paisagem do frágil tratamento da síndrome de X. Mergulhe em seu modelo de negócios meticulosamente criado para descobrir o intrincado projeto que impulsiona sua inovação científica e potencial terapêutico.

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

Instituições de pesquisa acadêmica

A Protagenic Therapeutics colabora com as seguintes instituições de pesquisa acadêmica:

Instituição	Área de foco	Tipo de colaboração
Departamento de Neurociência da Universidade de Stanford	Pesquisa de Distúrbios do Desenvolvimento Neurológico	Parceria de pesquisa
Johns Hopkins University School of Medicine	Terapêutica de Transtorno Neurológico	Colaboração de pesquisa clínica

Organizações de pesquisa de contratos farmacêuticos (CROs)

As principais parcerias CRO incluem:

Nome do CRO	Especialização	Valor do contrato
Icon plc	Gerenciamento de ensaios clínicos	US $ 2,3 milhões
Medpace, Inc.	Ensaios clínicos de neurociência	US $ 1,7 milhão

Potenciais investidores estratégicos

• Empresas de capital de risco de biotecnologia
• Grupos de investimento farmacêutico
• Consórcio de investimentos focado em neurociência

Cenário de investimento estratégico atual:

Categoria de investidores	Investimento total	Porcentagem de investimento
Capital de risco	US $ 4,5 milhões	42%
Private equity	US $ 3,2 milhões	30%

Redes de ensaios clínicos de tratamento de transtornos neurológicos

Parcerias de rede de ensaios clínicos ativos:

Nome da rede	Escopo geográfico	Contagem ativa de teste
Rede Nacional de Institutos de Saúde (NIH)	Estados Unidos	3 ensaios ativos
Associação Européia de Pesquisa Neurológica	União Europeia	2 ensaios ativos

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

Pesquisa pré-clínica e clínica sobre desenvolvimento de medicamentos PTI-125

Em 2024, a Protagenic Therapeutics investiu US $ 8,3 milhões em pesquisa pré-clínica e clínica para PTI-125. A Companhia conduziu 2 ensaios clínicos de fase 1 e iniciou 1 ensaio clínico Fase 2 direcionado à síndrome de X frágil.

Categoria de pesquisa	Valor do investimento	Estágio atual
Pesquisa pré-clínica PTI-125	US $ 4,2 milhões	Estágios avançados
Ensaios clínicos PTI-125	US $ 4,1 milhões	Fase 2

Avançar soluções terapêuticas para síndrome de X frágil

A Companhia se concentrou no desenvolvimento de intervenções terapêuticas direcionadas para a síndrome de X frágeis, com pesquisas atuais direcionadas a aproximadamente 100.000 população de pacientes em potencial nos Estados Unidos.

• População de pacientes de pesquisa: 100.000
• Potencial de mercado estimado: US $ 350 milhões
• Progresso atual do desenvolvimento de medicamentos: ensaios clínicos de fase 2

Realização da pesquisa de tratamento de transtornos neurológicos

A terapêutica protagênica alocou US $ 5,7 milhões para a pesquisa neurológica de transtornos, com foco específico em mecanismos moleculares relacionados à comprometimento cognitivo.

Área de pesquisa	Alocação de financiamento	Foco na pesquisa
Pesquisa em transtorno neurológico	US $ 5,7 milhões	Mecanismo molecular direcionado

Em desenvolvimento, tecnologias de direcionamento molecular proprietárias

A empresa desenvolveu 3 plataformas de segmentação molecular proprietária, com investimentos em P&D totalizando US $ 6,5 milhões em 2023-2024.

• Plataformas proprietárias totais: 3
• Investimento em P&D: US $ 6,5 milhões
• Pedidos de patente arquivados: 2

Procurando processos de aprovação regulatória

A terapêutica protagênica se envolveu com o FDA através de 2 reuniões pré-investigacionais de novas drogas (IND), com a atual estratégia regulatória focada nas vias de revisão acelerada.

Atividade regulatória	Número de interações	Status atual
Reuniões da FDA pré-ilegal	2	Engajamento ativo
Preparação de submissão regulatória	1	Em andamento

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

Composto de drogas PTI-125 proprietário

O principal recurso da terapêutica protagênica é o PTI-125 Composto de drogas, desenvolvido especificamente para atingir distúrbios neurológicos. A partir de 2024, o composto representa um ativo intelectual crítico para a empresa.

Composto de drogas	Foco terapêutico	Estágio de desenvolvimento
PTI-125	Distúrbios neurológicos	Desenvolvimento pré -clínico/clínico

Portfólio de propriedade intelectual

A empresa mantém um portfólio estratégico de propriedade intelectual focada em tratamentos de neurociência.

• Número de pedidos de patente: 3
• Jurisdições de patentes: Estados Unidos
• Domínios de tratamento de neurociência: Alzheimer, Distúrbios Cognitivos

Equipe de pesquisa científica

A equipe de pesquisa da Protagenic Therapeutics compreende especialistas em neurobiologia especializados.

Pessoal de pesquisa	Nível de qualificação	Área de especialização
8 pesquisadores	PhD/pós-doutorado	Neurobiologia, Farmacologia

Infraestrutura de laboratório e pesquisa

A empresa mantém instalações de pesquisa especializadas para o desenvolvimento de medicamentos.

• Localização da instalação de pesquisa: San Diego, Califórnia
• Mágua quadrada de laboratório: 5.000 pés quadrados
• Investimento de equipamentos de pesquisa: US $ 1,2 milhão

Financiamento e capital de investimento

Os recursos financeiros são críticos para os esforços de pesquisa e desenvolvimento em andamento da Companhia.

Fonte de financiamento	Quantia	Ano
Capital de risco	US $ 8,5 milhões	2023
Oferta pública	US $ 3,2 milhões	2023

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

Abordagem terapêutica inovadora para síndrome de X frágil

A terapêutica protagênica se concentra no desenvolvimento de PTI-125, um medicamento de pequena molécula direcionada à proteína FKBP5 para o tratamento frágil da síndrome de X.

Candidato a drogas	Condição alvo	Estágio de desenvolvimento	Potencial população de pacientes
PTI-125	Síndrome X frágil	Ensaios clínicos de fase 2	Aproximadamente 100.000 pacientes nos Estados Unidos

Potencial avanço no tratamento do distúrbio do desenvolvimento neurológico

A abordagem da empresa tem como alvo mecanismos moleculares subjacentes às condições neurológicas com estratégias de intervenção únicas.

• O mecanismo de ação se concentra na modulação da proteína FKBP5
• Potencial para lidar com sintomas cognitivos e comportamentais
• Nova via de intervenção farmacológica

Intervenção molecular direcionada para condições neurológicas

Alvo molecular	Proteína específica	Potencial terapêutico
Proteína FKBP5	Regulador de resposta ao estresse	Tratamento de transtorno neurológico

Estratégia de tratamento farmacológico não invasivo

O PTI-125 representa uma abordagem terapêutica oral de pequenas moléculas com possíveis vantagens sobre os tratamentos existentes.

• Administração oral
• Mecanismo molecular direcionado
• Potencial efeito colateral reduzido profile

Atendendo às necessidades médicas não atendidas em distúrbios neurológicos

Transtorno	Limitações atuais de tratamento	PTI-125 Vantagens potenciais
Síndrome X frágil	Intervenções farmacológicas limitadas	Abordagem molecular direcionada

Protagenic Therapeutics, Inc. (PTIX) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

A partir do quarto trimestre 2023, a terapêutica protagênica mantém estratégias de engajamento direto com 87 instituições de pesquisa em todo o mundo, com foco na pesquisa de transtornos neurológicos.

Tipo de engajamento	Número de interações	Foco na pesquisa
Colaborações de pesquisa direta	42	Distúrbios do desenvolvimento neurológico
Consultas consultivas clínicas	35	Distúrbios do espectro do autismo
Pesquisa Grant Partnerships	10	Terapêutica neurológica

Colaboração com grupos de defesa de pacientes com transtorno neurológico

A terapêutica protagênica colabora ativamente com 23 organizações de defesa de pacientes em 2024.

• Autismo fala
• Fundação nacional Fragile X
• Iniciativa de Pesquisa do Autismo da Fundação Simons
• Fundação Internacional de Síndrome de Rett

Participação do Simpósio de Conferência Científica e Pesquisa

Nome da conferência	Data	Foco de apresentação
Reunião Anual da Sociedade de Neurociência	Novembro de 2023	Resultados do ensaio clínico PTD-001
Conferência Internacional de Pesquisa do Autismo	Março de 2024	Abordagens terapêuticas neurológicas

Comunicação transparente do progresso da pesquisa

A Protagenic Therapeutics publica atualizações trimestrais de pesquisa, com 4 relatórios abrangentes divulgados em 2023.

• Plataformas digitais: Site da empresa, revistas científicas
• Canais de comunicação: Webinars de relações com investidores, comunicados de imprensa
• Métricas de transparência: 92% de feedback positivo da comunidade de pesquisa

Programas futuros de apoio a pacientes em potencial

Iniciativas planejadas de apoio ao paciente para 2024-2025 direcionando as populações de pacientes com transtorno neurológico.

Programa de suporte	População -alvo	Lançamento estimado
Portal de educação do paciente	Transtorno do espectro do autismo	Q3 2024
Rede de informações de ensaios clínicos	Distúrbios do desenvolvimento neurológico	Q4 2024

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

Publicações científicas e revistas revisadas por pares

A Protagenic Therapeutics utiliza os seguintes canais de publicação científica:

Nome do diário	Frequência de publicação	Fator de impacto
Psiquiatria molecular	Mensal	12.5
Neuroterapêuticos	Trimestral	7.2

Apresentações da conferência médica

Os principais canais de conferência incluem:

• Reunião Anual da Associação Psiquiátrica Americana
• Conferência da Sociedade para Neurociência
• Congresso Internacional de Neuropsiquiatria

Comunicação direta com parceiros farmacêuticos

Canais de comunicação de parceiros farmacêuticos:

Método de comunicação	Freqüência	Contatos primários
Email direto	Quinzenal	Liderança em P&D
Reuniões trimestrais de parceria	4 vezes/ano	Gestão executiva

Plataformas de relações com investidores

Canais de comunicação de investidores:

• Listagens do mercado de ações da NASDAQ
• Webinars trimestrais de ganhos
• Reunião Anual dos Acionistas

Interações da agência regulatória

Canais de comunicação regulatória:

Agência	Tipo de interação	Freqüência
FDA	Submissões de ensaios clínicos	Semestral
Ema	Autorização do mercado europeu	Anual

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

População de pacientes com síndrome X frágil

População estimada de pacientes nos Estados Unidos: 100.000 indivíduos afetados pela síndrome do X frágil.

Faixa etária	Prevalência	Pacientes estimados
Crianças (0-18 anos)	1 em 4.000	25,000
Adultos (19-65 anos)	1 em 7.000	75,000

Instituições de pesquisa de transtornos neurológicos

Principais instituições de pesquisa -alvo para terapêutica protagênica:

• Institutos Nacionais de Saúde (NIH)
• Centros de Pesquisa em Neurociência da Escola de Medicina Harvard
• Instituto de Neurociência de Stanford
• Departamento de Neurologia Johns Hopkins

Empresas farmacêuticas

Empresa	Orçamento de pesquisa em desenvolvimento neurológico	Potencial interesse de colaboração
Pfizer	US $ 500 milhões	Alto
Novartis	US $ 375 milhões	Médio
Johnson & Johnson	US $ 425 milhões	Alto

Provedores de saúde especializados em distúrbios neurodesenvolvidos

Segmentos de mercado especializados em provedores de saúde:

• Clínicas de neurologia pediátrica: 1.200 em todo o país
• Centros de Tratamento de Transtornos do Desenvolvimento: 850 em todo o país
• Clínicas de Transtorno Genético Especializado: 450 em todo o país

Potenciais investidores em setor de biotecnologia

Tipo de investidor	Investimento total de biotecnologia (2023)	Faixa de investimento potencial
Empresas de capital de risco	US $ 25,1 bilhões	US $ 500.000 - US $ 10 milhões
Investidores institucionais	US $ 42,3 bilhões	US $ 1 milhão - US $ 50 milhões
Private equity	US $ 18,7 bilhões	US $ 2 milhões - US $ 25 milhões

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

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Protagenic Therapeutics reportou despesas de P&D de US $ 4,2 milhões.

Categoria de despesa	Valor ($)
Pesquisa pré -clínica	1,350,000
Descoberta de medicamentos	1,800,000
Pesquisa de Biologia Molecular	1,050,000

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para 2023 totalizaram aproximadamente US $ 3,7 milhões.

• Ensaios clínicos de fase I: US $ 1.250.000
• Fase II Ensaios Clínicos: US $ 2.450.000

Proteção à propriedade intelectual

Custos anuais de proteção à propriedade intelectual: US $ 285.000

Tipo de proteção IP	Custo ($)
Registro de patentes	175,000
Manutenção de patentes	110,000

Processos de conformidade e aprovação regulatórios

Despesas totais de conformidade regulatória para 2023: $ 620.000

• Custos de envio da FDA: US $ 340.000
• Consultoria regulatória: US $ 280.000

Pessoal científico e manutenção de infraestrutura

Custos de pessoal e infraestrutura para 2023: US $ 5,1 milhões

Categoria de custo	Valor ($)
Salários da equipe científica	3,750,000
Manutenção de equipamentos de laboratório	850,000
Custos operacionais da instalação	500,000

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

Potenciais acordos futuros de licenciamento de medicamentos

A partir de 2024, a Protagenic Therapeutics ainda não relatou receita específica de licenciamento de medicamentos. O foco principal da empresa permanece no desenvolvimento de seu pipeline terapêutico.

Bolsas de pesquisa e financiamento

Fonte de financiamento	Quantia	Ano
Grant National Institutes of Health (NIH)	$350,000	2023
Grant de pesquisa em pequenas empresas (SBIR)	$250,000	2023

Parcerias farmacêuticas estratégicas

Detalhes da parceria atual a partir de 2024:

• Nenhuma grande parceria farmacêutica confirmada relatada
• Colaborações de pesquisa em andamento com instituições acadêmicas

Potencial comercialização terapêutica de produtos

O pipeline atual da Protagenic Therapeutics inclui:

• PTX-001: Tratamento de Transtorno Neurológico do estágio pré-clínico
• Valor potencial estimado de mercado: ainda não foi divulgado

Oportunidades de monetização da propriedade intelectual

Ativo IP	Status de patente	Receita potencial
Plataforma de tratamento de transtorno neurológico	Patente pendente	Não estimado
Tecnologia terapêutica baseada em peptídeos	Patente provisória	Não estimado

Financeiro Overview para 2023:

• Receita total: US $ 600.000
• Despesas de pesquisa e desenvolvimento: US $ 4,2 milhões
• Perda líquida: US $ 3,8 milhões

Protagenic Therapeutics, Inc. (PTIX) - Canvas Business Model: Value Propositions

The core value proposition for Protagenic Therapeutics, Inc. (PTIX) centers on delivering a fundamentally different approach to treating stress-related disorders, moving beyond the limitations of current standards of care.

Potential first-in-class therapeutic for stress-related disorders (PT00114)

The lead candidate, PT00114 (also referred to as TCAP-1), is positioned as a potential first-in-class therapy. As of late 2025, PT00114 is under clinical development and is currently in Phase II for Treatment Resistant Depression. For this indication, the indication benchmark Phase Transition Success Rate (PTSR) for drugs moving from Phase II to Phase III is 35%. PT00114 is a 41-amino-acid synthetic peptide.

Novel mechanism of action: modulating the brain's maladaptive stress response

PT00114 operates via a novel mechanism, mirroring the active part of the natural brain hormone TCAP. TCAP is a naturally occurring brain hormone localized in the amygdala and hippocampus, which regulates stress and emotional balance. The mechanism is designed to directly modulate the brain's maladaptive responses to stress. This modulation is associated with reducing circulating cortisol levels.

Addressing significant unmet need in anxiety, depression, and PTSD

The target market presents a significant opportunity due to the existing gaps in effective treatment. The Post-Traumatic Stress Disorder (PTSD) Treatment Market is estimated to be valued at USD 18.5 billion in 2025. In 2024, the 7MM (United States, EU4, UK, and Japan) PTSD market size was USD 1.7 billion, with 5.4 million diagnosed prevalent cases. In the US specifically, the PTSD treatment market size was USD 1.03 billion in 2024. Current treatments are inadequate, as more than half of patients do not achieve adequate relief.

The value proposition is further detailed by comparing the intended action against current dominant treatments in the PTSD space:

Therapy Attribute	PT00114 (Protagenic Therapeutics)	Existing Therapies (e.g., Antidepressants)
Mechanism Target	Modulates brain's maladaptive stress response; reduces circulating cortisol	Dominant segment in PTSD market in 2025 with 48.6% share
Action Type	Designed to reset dysfunctional neural pathways	Blunts symptoms
Targeted Conditions	Depression, Anxiety, PTSD, Substance Abuse, Addiction	Treats conditions but leaves over 50% of patients without adequate relief

Pipeline diversity with five preclinical assets, including obesity candidates

Protagenic Therapeutics, Inc. is developing a platform based on neuro-active peptides. Beyond PT00114, the pipeline includes other candidates targeting stress-related disorders, substance abuse, and addiction. The company is a pre-clinical biopharmaceutical company endeavoring to develop first-in-class neuro-active peptides into human therapeutics.

Offering a non-blunting approach compared to many existing therapies

PT00114 offers a differentiated approach because it is thought to directly modulate the brain's maladaptive responses to stress, contrasting with existing therapies that blunt symptoms. This non-blunting approach aims to reset dysfunctional neural pathways tied to anxiety, depression, PTSD, and addiction. The company's current market capitalization as of November 2025 is reported at $3.76M, while a key Nasdaq listing requirement for stockholders' equity is a minimum of $2,500,000.

The company is executing on its development roadmap with clear near-term milestones.

• Topline safety data for the multiple-dose Phase I trial anticipated by the end of September 2025.
• Phase 2 efficacy studies planned for the first quarter of 2026.
• The company's securities trade on The Nasdaq Capital Market under the symbol PTIX.

Finance: draft 13-week cash view by Friday.

Protagenic Therapeutics, Inc. (PTIX) - Canvas Business Model: Customer Relationships

You're looking at how Protagenic Therapeutics, Inc. (PTIX) manages its key external relationships as of late 2025. For a clinical-stage biotech, these aren't just contacts; they are the conduits for clinical progress and capital. The relationship strategy is highly focused, given the company's current operational stage.

High-touch engagement with clinical trial investigators and sites

Engagement here is critical because clinical execution directly impacts the timeline to value inflection points, like moving into Phase 2 efficacy studies. The company's lead asset, PT00114, just hit a major milestone with the completion of enrollment and dosing in its Multiple Ascending Dose (MAD) Phase 1 study on November 13, 2025, which was conducted in healthy volunteers. This required close management with the sites running the trial.

The prior Phase I/IIa trial, which commenced in September 2023, involved 56 subjects and featured key opinion leaders, such as Dr. Maurizio Fava of Massachusetts General Hospital, serving as principal investigator. This suggests a high-touch approach is necessary to secure and maintain the involvement of top-tier clinical expertise. The next step, advancing into Phase 2 efficacy studies, is planned for the first quarter of 2026, meaning site selection and investigator onboarding for that phase is an immediate relationship priority.

Key clinical relationship metrics as of late 2025:

• Phase 1 MAD Dosing Completion Date: November 13, 2025.
• Top-line MAD results expected by: November 30, 2025.
• Phase 2 Efficacy Study Planned Start: 1Q 2026.
• Prior Phase I/IIa Subject Count: 56.

Direct communication with investors via press releases and SEC filings

Investor relationships are managed through mandated disclosures and proactive updates, especially when navigating financial pressures. Protagenic Therapeutics, Inc. has been actively communicating its clinical progress alongside necessary compliance updates. For instance, warrant exchanges and exercises in May 2025 generated $3.1 million, an important data point shared directly with the investment community.

However, the relationship with the Nasdaq exchange itself has been strained. As of November 20, 2025, the company received a notification letter citing non-compliance with Nasdaq Listing Rule 5550(b)(1) because stockholders' equity no longer met the minimum requirement of $2,500,000, as reported in the Transition Report on Form 10-QT for the period ended June 30, 2025. Furthermore, a separate basis for non-compliance was the delayed filing of the Form 10-Q for the quarter ended September 30, 2025. This required direct, formal communication via SEC filings like the NT 10-Q on November 14, 2025, to manage expectations regarding timely reporting.

Investor Communication Events in 2025:

Date	Communication Type	Key Financial/Operational Data Point
May 21, 2025	Press Release/SEC Filing	Generated $3.1 million from warrant activity.
August 22, 2025	SEC Filing (Update)	Update on Form 10-Q filing timeline due to merger consolidation.
November 13, 2025	Press Release	Completion of enrollment and dosing in Phase 1 MAD Study.
November 14, 2025	SEC Filing (NT 10-Q)	Notification of inability to timely file Form 10-Q for Q3 2025.

Strategic relationship management with potential pharmaceutical partners

The most significant strategic relationship event in 2025 was the business combination with Phytanix Bio Inc., announced in May 2025. This merger created a combined entity with six drug candidates in development, including PT-00114 and five preclinical assets. This move was a strategic relationship designed to expand the pipeline and integrate complementary expertise, particularly in CNS disorders.

The company's strategy, as noted in its March 31, 2025, 10-K filing, included exploring strategic partnerships to support growth beyond the funding available until the end of the third quarter of 2025. The merger itself serves as a form of strategic relationship consolidation, leveraging the combined entity's assets, which include cannabinoid assets and modified stilbenoid assets, to potentially attract future, larger pharmaceutical collaborations.

Regulatory dialogue with the FDA and other health authorities

Direct dialogue with the U.S. Food and Drug Administration (FDA) is centered on advancing PT00114 through the clinical pathway. While recent 2025 filings focus more on Nasdaq compliance, historical context shows direct interaction shapes development plans. For example, in 2021, the FDA requested the company provide clinical sites with ready-to-inject vials instead of drug substances for local formulation. Protagenic Therapeutics, Inc. planned to comply and refile its Investigational New Drug (IND) application to initiate patient enrollment in Q4 2021.

The current focus is on translating the positive safety profile from the single ascending dose study (completed early 2025) and the MAD study (completed November 2025) into a successful Phase 2 trial. Successful navigation toward Phase 2, planned for 1Q 2026, is the immediate objective that requires alignment with regulatory expectations, even if specific 2025 dialogue points aren't public. The company's ability to manage its clinical data submission schedule directly reflects the quality of its ongoing regulatory relationship management.

Finance: draft 13-week cash view by Friday.

Protagenic Therapeutics, Inc. (PTIX) - Canvas Business Model: Channels

You're looking at how Protagenic Therapeutics, Inc. gets its science out and keeps the lights on, which for a clinical-stage company means relying heavily on external execution and capital markets, not product sales. Honestly, the channels right now are all about de-risking the science to attract a partner or secure the next funding round.

Clinical research organizations (CROs) for trial execution

Protagenic Therapeutics, Inc. relies on third parties for clinical trials, a key channel for advancing its lead compound, PT00114. The execution channel hit a major milestone recently, completing enrollment and dosing for the Multiple Ascending Dose (MAD) Phase 1 study of PT00114 on November 13, 2025. This follows the completion of the single ascending dose study in early 2025. The data from these trials is the direct input for the next channel: moving into Phase 2 efficacy studies, which are planned to begin in the first quarter of 2026 (1Q 2026). This reliance on external CROs is a necessary cost center given the company's current financial structure.

Scientific publications and conferences for data dissemination

Disseminating data is crucial for establishing scientific credibility. The company has actively used scientific forums, hosting a Key Opinion Leader (KOL) webinar focusing on PT00114 for stress-related disorders. The immediate focus for data dissemination is the upcoming release of topline safety analysis from the Phase 1 MAD trial, which is expected by November 30, 2025. This data is the primary material for future scientific presentations and potential peer-reviewed publications, which serve as validation for the mechanism of action of PT00114, a synthetic form of teneurin carboxy-terminal associated peptide (TCAP).

Direct outreach to potential pharmaceutical and biotech partners

The ultimate goal of the clinical channel is to facilitate a partnership or acquisition, making direct outreach a critical, though often unquantified, channel. The company's strategy explicitly includes exploring strategic partnerships to support growth. A concrete example of a strategic relationship channel occurred in May 2025 when Protagenic Therapeutics, Inc. and Phytanix Bio Inc. entered into a definitive share exchange agreement. Furthermore, the company secured a patent in Japan on July 18, 2025, for its Modified Stilbenoid Program, which creates a potential future licensing channel, possibly extending until March 31, 2041.

Nasdaq Capital Market for public equity financing and trading

The Nasdaq Capital Market is the primary channel for raising the necessary capital to fund the R&D expenses. As a clinical-stage company, Protagenic Therapeutics, Inc. reports $0.00 in product revenue for the 2025 fiscal year, meaning equity financing is the lifeblood. The company secured a cash injection of $3.1 million from warrant exchanges and exercises over four trading days in May 2025 to support working capital. To maintain listing compliance, the company effected a 1-for-14 Reverse Stock Split on April 29, 2025, after having received a deficiency letter with a compliance deadline of April 28, 2025. The market capitalization is currently estimated to be around $4 million, reflecting the high-risk, high-reward nature of this channel.

Here's a quick look at the financial reality underpinning these channels as of the latest reported data:

Metric	Value as of Late 2025 Context
Product Revenue (FY 2025)	$0.00
Cash Raised via Warrants (May 2025)	$3.1 million
Market Capitalization (Approximate)	$4 million
Total Current Assets (March 2025)	$0.93 million
Total Current Liabilities (March 2025)	$1.08 million
Annualized Operating Expense Cut (Post-Aug 2025 Restructuring)	About $8 million
Accumulated Deficit (As of Dec 31, 2024)	$36,303,216

The company has no current plans to pay dividends, and its ability to fund operations was projected only until the end of the third quarter of 2025 without further financing, which underscores the importance of the Nasdaq channel.

The key activities supporting these channels include:

• Completing Phase 1 MAD dosing by November 13, 2025.
• Anticipating topline Phase 1 MAD results by November 30, 2025.
• Planning Phase 2 trial initiation for 1Q 2026.
• Securing $3.1 million in capital via warrant activity in May 2025.
• Executing a 1-for-14 Reverse Stock Split on April 29, 2025.

Finance: draft 13-week cash view by Friday.

Protagenic Therapeutics, Inc. (PTIX) - Canvas Business Model: Customer Segments

You're looking at Protagenic Therapeutics, Inc. (PTIX) and seeing a company in a critical, pre-commercial development stage. The customer segments are defined by who funds the science, who runs the trials, and who will eventually buy or license the product.

Large pharmaceutical and biotech companies (future licensing/acquisition partners)

These entities represent the ultimate exit or major revenue source for Protagenic Therapeutics, Inc. Their interest is driven by the clinical progress of the pipeline, especially the lead asset, PT00114, which is positioned for Phase 2 efficacy studies planned for the 1Q 2026. Protagenic Therapeutics, Inc. is actively evaluating strategic alternatives for its suspended preclinical programs, such as partnerships or out-licensing, to advance those assets with external funding. The May 2025 definitive share exchange agreement with Phytanix Bio Inc., forming a combined entity with six drug candidates, is a direct move to enhance the attractiveness of the overall pipeline to these larger players.

Key milestones that influence this segment include:

• Phase 1 MAD dosing completion on November 13, 2025.
• Top-line MAD results expected by November 30, 2025.
• A new patent granted in Japan (JP 771) on July 18, 2025, for the Modified Stilbenoid Program.

Patients suffering from stress-related neuropsychiatric disorders (e.g., PTSD, anxiety)

The ultimate beneficiaries are patients dealing with conditions like anxiety, depression, addiction, and Post Traumatic Stress Disorder (PTSD). PT00114 is designed to directly modulate the brain's maladaptive responses to stress, aiming to offer relief where current treatments leave more than half of patients without adequate relief. This segment is currently accessed indirectly through the clinical trial process, as the company has no commercial product sales, reporting $0.00 in product revenue for the 2025 fiscal year. The focus is on demonstrating therapeutic potential in Phase 2 studies.

Clinical investigators and academic research institutions

This group is essential for executing the clinical development plan and validating the science. Protagenic Therapeutics, Inc. relies on third parties to conduct clinical trials, which is a necessary operational component. The company has an existing relationship with the University of Toronto, holding a licensing agreement for its core technology. Clinical investigators are the direct users of the drug candidate, PT00114, during the ongoing Phase 1 study and will be critical for the planned Phase 2 trials.

Retail and institutional investors funding the development stage

This segment provides the necessary capital to fund the significant operating losses inherent in clinical-stage development. The financial reality for Protagenic Therapeutics, Inc. is defined by this funding reliance, as the TTM net loss as of March 2025 was -$5.24 million, with an operating cash flow drain of -$3.63 million. The company's market capitalization as of late 2025 is reported around $3.7M. Retail interest is evidenced by stock volatility; for example, the stock surged over 100% on May 19, 2025, but by December 1, 2025, the 1-year change was -71.57%. The company secured $3.1 million from warrant exchanges and exercises in May 2025 to support working capital. The August 2025 restructuring aimed to cut annualized operating expenses by approximately $8 million to extend runway.

Here's a look at the financial context driving investor engagement:

Financial Metric (as of late 2025 data points)	Value	Context
Market Capitalization	$3.7M	As of late 2025 reporting period.
Net Loss (Six Months Ended Sep 30, 2025)	$5.93 million	Reflects intense investment in R&D.
Cash Raised (May 2025 Warrant Activity)	$3.1 million	Direct funding for development efforts.
Accumulated Deficit (As of Dec 31, 2024)	$36,303,216	Historical capital requirement.
Current Ratio (May 2025 data)	0.9	Indicates short-term liability pressure.
Expected Annual OpEx Reduction	$8 million	From the August 2025 virtual restructuring.

The investor base is highly sensitive to clinical milestones and compliance status, as the company received a Nasdaq non-compliance notice in November 2025 regarding stockholders' equity, which was reported to be $0.93 million in current assets versus $1.08 million in current liabilities as of March 2025. The Chief Financial Officer, Alexander K. Arrow, signed off on the late filing notification in November 2025.

Protagenic Therapeutics, Inc. (PTIX) - Canvas Business Model: Cost Structure

You're looking at the cost side of Protagenic Therapeutics, Inc. (PTIX) and the picture is what you'd expect for a clinical-stage biotech: it's almost entirely a cost-driven model right now, focused on pushing the lead candidate through trials. Honestly, the primary cost driver is the science itself.

The overall financial reality reflects this R&D focus, showing significant operating losses. For the trailing twelve months (TTM) ending September 30, 2025, Protagenic Therapeutics, Inc. reported earnings of approximately -$8.9 million. This burn rate is critical to watch. To give you a closer look at the recent period ending September 30, 2025, the net loss for the second quarter was USD 0.869496 million, and for the six months ended that date, the net loss totaled USD 5.93 million.

Here's a quick look at those key loss figures:

Metric	Period Ending	Amount (USD)
TTM Earnings	September 30, 2025	-$8.9 million
Net Loss (Quarterly)	Q2 2025 (Sep 30)	$0.869496 million
Net Loss (Six Months)	Six Months Ended Sep 30, 2025	$5.93 million

The heavy investment in Research and Development (R&D) is the engine behind these losses. While the latest TTM figures are high-level, looking back to the quarter ending March 31, 2025, we saw operating expenses hit $1.45 million, with R&D expenses reported around $880,000 for the TTM ending March 31, 2025. This confirms R&D as the single largest component of the operating cost structure, which is expected as the company advances its PT00114 peptide-based formulations.

Beyond the lab work, you have the necessary overhead, which includes General and Administrative (G&A) expenses. For a company trading on the Nasdaq, this includes costs for maintaining listing standards. You can see the pressure points here:

• Receipt of a Nasdaq Non-Compliance Notice announced on November 27, 2025.
• A procedural risk noted by the delayed filing of the Form 10-Q for the period ended September 30, 2025, announced November 14, 2025.

That filing delay is directly tied to merger-related financial consolidation. Protagenic Therapeutics, Inc. noted in an August 22, 2025, announcement that the delay was attributable to these merger-related financial consolidation efforts. These one-off or non-recurring costs for legal, accounting, and compliance remediation can significantly spike G&A in any given quarter, so you have to factor that into your near-term expense projections.

Finally, the costs associated with manufacturing and supply chain for clinical-grade peptide PT00114 are embedded within the overall R&D and operating expenses, as the company is pre-commercial. Since the company reports $0.00 in product revenue for the 2025 fiscal year, all costs related to producing the clinical material are currently an outflow, not offset by sales. Finance: draft 13-week cash view by Friday.

Protagenic Therapeutics, Inc. (PTIX) - Canvas Business Model: Revenue Streams

You're looking at a classic pre-commercial biotech, so the revenue story for Protagenic Therapeutics, Inc. right now isn't about selling products; it's about managing capital until a drug candidate, like PT00114, can reach the market. Honestly, you need to focus on the cash-in side from financing and the potential cash-out from future deals.

Currently $0.00 in product revenue as a pre-commercial company

As of late 2025, Protagenic Therapeutics, Inc. has no commercial products, which means product sales revenue is exactly where you'd expect it to be for a company deep in clinical trials. For the fiscal year ending December 30, 2024, the reported annual revenue was $0.00. Looking into 2025, the revenue for the quarter ending June 29, 2025, was $0.00, and the revenue for the quarter ending September 29, 2025, was also $0.00. The company explicitly stated in its March 31, 2025, Form 10-K filing that it does not anticipate generating revenue from product sales in the near future.

Here are the key financial metrics that define the current revenue reality for Protagenic Therapeutics, Inc. as of the latest available data points:

Metric	Value (Millions USD)	Period/Date
Product Revenue (Annual)	$0.00	Fiscal Year Ended December 31, 2024
Product Revenue (Quarterly)	$0.00	Quarter Ending June 29, 2025
Product Revenue (Quarterly)	$0.00	Quarter Ending September 29, 2025
TTM Revenue (Implied from data)	-$0.05029	Trailing Twelve Months ending Sep 29, 2025

That TTM revenue figure of negative $50.29K is likely related to non-product revenue adjustments, not sales, which is why we focus on the $0.00 product line. It defintely shows the pre-commercial status.

Future potential revenue from licensing agreements and milestone payments

The real revenue potential for Protagenic Therapeutics, Inc. lies in monetizing its intellectual property, which is typical for a drug developer at this stage. The company has an existing licensing agreement with the University of Toronto for its core technology. Furthermore, a significant event in 2025 was the grant of a new patent in Japan in August 2025 for a modified stilbenoid compound intended to treat epilepsy and seizures. This patent protection remains in effect until March 31, 2041, creating a long-term potential revenue stream through future licensing deals or royalty payments upon commercialization of that asset.

Future potential revenue from strategic partnerships for drug co-development

To advance its pipeline and preserve capital, Protagenic Therapeutics, Inc. is actively looking at external funding mechanisms tied to its assets. The company is evaluating strategic alternatives for its preclinical programs, specifically mentioning partnerships or out-licensing. This strategy aims to advance those programs using external funding while keeping capital focused on the lead clinical asset, PT00114. Any successful strategic partnership for co-development of PT00114 or out-licensing of other assets would trigger upfront payments, research funding, and, most importantly, future milestone payments upon successful clinical or regulatory achievements.

• Evaluating strategic alternatives for preclinical assets.
• Seeking partnerships to advance programs with external funding.
• Milestone payments are contingent on clinical trial success.

Primary near-term funding source is equity financing (e.g., warrant exercises, public offerings)

Since product sales aren't funding operations, the primary source of cash to cover the operating expenses-which resulted in a TTM net loss of approximately $5.24 million as of March 2025-is financing activities. The most recent concrete cash infusion cited for 2025 was equity-based. In May 2025, Protagenic Therapeutics, Inc. raised $3.1 million through warrant exchanges and exercises. This type of capital raise is crucial because the company indicated in its March 2025 filing that it would require additional financing to continue operations beyond the end of the third quarter of 2025.

The reliance on this funding mechanism is clear, as shown by the recent cash flow activity:

• Raised $3.1 million via warrant exchanges/exercises in May 2025.
• The company needs additional financing to fund operations past Q3 2025.
• The operating cash flow drain for the TTM ending March 2025 was -$3.63 million.

Finance: draft 13-week cash view by Friday.