Protagenic Therapeutics, Inc. (PTIX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Protagenic Therapeutics, Inc. (PTIX) se encuentra a la vanguardia de la innovadora investigación de trastornos neurosgráficos, pionero en tecnologías de orientación molecular innovadora que podrían revolucionar el tratamiento para afecciones neurológicas complejas. Con su compuesto de medicamento PTI-125 patentado y un enfoque estratégico para abordar las necesidades médicas no satisfechas, esta compañía de biotecnología está preparada para transformar potencialmente el panorama del tratamiento de síndrome X frágil. Sumerja su lienzo de modelo de negocio meticulosamente elaborado para descubrir el intrincado plan que impulsa su innovación científica y su potencial terapéutico.

Protagenic Therapeutics, Inc. (PTIX) - Modelo de negocio: asociaciones clave

Instituciones de investigación académica

La terapéutica protagénica colabora con las siguientes instituciones de investigación académica:

Institución	Área de enfoque	Tipo de colaboración
Departamento de Neurociencia de la Universidad de Stanford	Investigación de trastornos del desarrollo neurológico	Asociación de investigación
Facultad de Medicina de la Universidad Johns Hopkins	Terapéutica del trastorno neurológico	Colaboración de investigación clínica

Organizaciones de investigación de contratos farmacéuticos (CRO)

Las asociaciones clave de CRO incluyen:

Nombre de Cro	Especialización	Valor de contrato
Ícono plc	Gestión de ensayos clínicos	$ 2.3 millones
Medpace, Inc.	Ensayos clínicos de neurociencia	$ 1.7 millones

Inversores estratégicos potenciales

• Empresas de capital de riesgo de biotecnología
• Grupos de inversión farmacéutica
• Consorcios de inversión centrados en la neurociencia

Panario de inversión estratégica actual:

Categoría de inversionista	Inversión total	Porcentaje de inversión
Capital de riesgo	$ 4.5 millones	42%
Capital privado	$ 3.2 millones	30%

Tratamiento de trastorno neurológico Redes de ensayos clínicos

Asociaciones de red de ensayos clínicos activos:

Nombre de red	Alcance geográfico	Recuento de prueba activo
Red de los Institutos Nacionales de Salud (NIH)	Estados Unidos	3 pruebas activas
Asociación Europea de Investigación Neurológica	unión Europea	2 pruebas activas

Protagenic Therapeutics, Inc. (PTIX) - Modelo de negocio: actividades clave

Investigación preclínica y clínica sobre el desarrollo de fármacos PTI-125

A partir de 2024, Protagenic Therapeutics ha invertido $ 8.3 millones en investigación preclínica y clínica para PTI-125. La compañía ha realizado 2 ensayos clínicos de fase 1 e inició 1 fase 2 ensayo clínico dirigido al síndrome de X frágil.

Categoría de investigación	Monto de la inversión	Etapa actual
PTI-125 Investigación preclínica	$ 4.2 millones	Etapas avanzadas
PTI-125 ensayos clínicos	$ 4.1 millones	Fase 2

Avance de soluciones terapéuticas para el síndrome de X frágil

La compañía se ha centrado en el desarrollo de intervenciones terapéuticas dirigidas para el síndrome de X frágil, con una investigación actual dirigida a aproximadamente 100,000 posibles población de pacientes en los Estados Unidos.

• Investigue la población de pacientes: 100,000
• Potencial de mercado estimado: $ 350 millones
• Progreso actual del desarrollo del fármaco: ensayos clínicos de fase 2

Realización de la investigación del tratamiento del trastorno neurológico

La terapéutica protagénica ha asignado $ 5.7 millones para la investigación del trastorno neurológico, con un enfoque específico en mecanismos moleculares relacionados con el deterioro cognitivo.

Área de investigación	Asignación de financiación	Enfoque de investigación
Investigación del trastorno neurológico	$ 5.7 millones	Mecanismo molecular objetivo

Desarrollo de tecnologías de orientación molecular patentada

La compañía ha desarrollado 3 plataformas de orientación molecular patentada, con inversiones de I + D por un total de $ 6.5 millones en 2023-2024.

• Plataformas de propiedad total: 3
• Inversión de I + D: $ 6.5 millones
• Solicitudes de patentes presentadas: 2

Perseguir procesos de aprobación regulatoria

Protagenic Therapeutics se ha involucrado con la FDA a través de 2 reuniones de nuevas drogas pre-investigadoras (IND), con una estrategia regulatoria actual centrada en las vías de revisión aceleradas.

Actividad regulatoria	Número de interacciones	Estado actual
Reuniones previas a la India de la FDA	2	Compromiso activo
Preparación de presentación regulatoria	1	En curso

Protagenic Therapeutics, Inc. (PTIX) - Modelo de negocio: recursos clave

Compuesto de drogas PTI-125 patentado

El recurso clave de la terapéutica protagénica es el Compuesto de drogas PTI-125, desarrollado específicamente para atacar trastornos neurológicos. A partir de 2024, el compuesto representa un activo intelectual crítico para la empresa.

Compuesto de drogas	Enfoque terapéutico	Etapa de desarrollo
PTI-125	Trastornos neurológicos	Desarrollo preclínico/clínico

Cartera de propiedades intelectuales

La compañía mantiene una cartera estratégica de propiedad intelectual centrada en los tratamientos de neurociencia.

• Número de solicitudes de patentes: 3
• Jurisdicciones de patentes: Estados Unidos
• Dominios de tratamiento de neurociencia: Alzheimer, trastornos cognitivos

Equipo de investigación científica

El equipo de investigación de Protagenic Therapeutics comprende expertos en neurobiología especializados.

Personal de investigación	Nivel de calificación	Área de experiencia
8 investigadores	Doctorado/postdoctoral	Neurobiología, Farmacología

Infraestructura de laboratorio e investigación

La compañía mantiene instalaciones de investigación especializadas para el desarrollo de medicamentos.

• Ubicación de la instalación de investigación: San Diego, California
• Laboratorio de pies cuadrados: 5,000 pies cuadrados
• Inversión en equipos de investigación: $ 1.2 millones

Capital de financiación e inversión

Los recursos financieros son críticos para los continuos esfuerzos de investigación y desarrollo de la Compañía.

Fuente de financiación	Cantidad	Año
Capital de riesgo	$ 8.5 millones	2023
Ofrenda pública	$ 3.2 millones	2023

Protagenic Therapeutics, Inc. (PTIX) - Modelo de negocio: propuestas de valor

Enfoque terapéutico innovador para el síndrome de X frágil

La terapéutica protagénica se centra en el desarrollo de PTI-125, un fármaco de molécula pequeña dirigida a la proteína FKBP5 para el tratamiento frágil del síndrome X.

Candidato a la droga	Condición objetivo	Etapa de desarrollo	Potencial de población de pacientes
PTI-125	Síndrome de X frágil	Ensayos clínicos de fase 2	Aproximadamente 100,000 pacientes en Estados Unidos

Posible avance en el tratamiento del trastorno del neurodesarrollo

El enfoque de la Compañía se dirige a los mecanismos moleculares subyacentes a las condiciones neurológicas con estrategias de intervención únicas.

• El mecanismo de acción se centra en la modulación de la proteína FKBP5
• Potencial para abordar los síntomas cognitivos y conductuales
• Nueva vía de intervención farmacológica

Intervención molecular dirigida para condiciones neurológicas

Objetivo molecular	Proteína específica	Potencial terapéutico
Proteína FKBP5	Regulador de respuesta al estrés	Tratamiento de trastorno neurológico

Estrategia de tratamiento farmacológico no invasivo

PTI-125 representa un enfoque terapéutico oral de molécula pequeña con posibles ventajas sobre los tratamientos existentes.

• Administración oral
• Mecanismo molecular objetivo
• Efecto secundario reducido potencial profile

Abordar las necesidades médicas no satisfechas en los trastornos neurológicos

Trastorno	Limitaciones de tratamiento actuales	PTI-125 Ventajas potenciales
Síndrome de X frágil	Intervenciones farmacológicas limitadas	Enfoque molecular dirigido

Protagenic Therapeutics, Inc. (PTIX) - Modelo de negocios: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir del cuarto trimestre de 2023, la terapéutica protagénica mantiene estrategias de participación directa con 87 instituciones de investigación a nivel mundial, centrándose en la investigación de trastornos neurológicos.

Tipo de compromiso	Número de interacciones	Enfoque de investigación
Colaboraciones de investigación directa	42	Trastornos del desarrollo neurológico
Consultas de asesoramiento clínico	35	Trastornos del espectro autista
Asociaciones de subvenciones de investigación	10	Terapéutica neurológica

Colaboración con trastorno neurológico Grupos de defensa del paciente

La terapéutica protagénica colabora activamente con 23 organizaciones de defensa del paciente en 2024.

• El autismo habla
• Fundación Nacional Fragile X
• Iniciativa de investigación de autismo de Simons Foundation
• Fundación Internacional de Síndrome Rett

Conferencia científica e participación en el simposio de investigación

Nombre de conferencia	Fecha	Enfoque de presentación
Reunión anual de la Sociedad de Neurociencia	Noviembre de 2023	Resultados del ensayo clínico PTD-001
Conferencia Internacional de Investigación del Autismo	Marzo de 2024	Enfoques terapéuticos neurológicos

Comunicación transparente del progreso de la investigación

Protagenic Therapeutics publica actualizaciones de investigación trimestrales, con 4 informes completos publicados en 2023.

• Plataformas digitales: Sitio web de la empresa, revistas científicas
• Canales de comunicación: Seminarios web de relaciones con los inversores, comunicados de prensa
• Métricas de transparencia: 92% Comentarios positivos de la comunidad de investigación

Programas potenciales de apoyo para futuros de los pacientes

Iniciativas de apoyo al paciente planificadas para 2024-2025 dirigidos a las poblaciones de pacientes con desorden neurológico.

Programa de apoyo	Población objetivo	Lanzamiento estimado
Portal de educación del paciente	Trastorno del espectro autista	P3 2024
Red de información de ensayos clínicos	Trastornos del desarrollo neurológico	P4 2024

Protagenic Therapeutics, Inc. (PTIX) - Modelo de negocios: canales

Publicaciones científicas y revistas revisadas por pares

Protagenic Therapeutics utiliza los siguientes canales de publicación científica:

Nombre del diario	Frecuencia de publicación	Factor de impacto
Psiquiatría molecular	Mensual	12.5
Neuroterapia	Trimestral	7.2

Presentaciones de conferencia médica

Los canales de conferencia clave incluyen:

• Reunión anual de la Asociación Americana de Asociación Psiquiátrica
• Conferencia de la Sociedad de Neurociencia
• Congreso Internacional de Neuropsiquiatría

Comunicación directa con socios farmacéuticos

Canales de comunicación de pareja farmacéutica:

Método de comunicación	Frecuencia	Contactos principales
Correo electrónico directo	Quincenal	Liderazgo de I + D
Reuniones de asociación trimestral	4 veces/año	Gestión ejecutiva

Plataformas de relaciones con los inversores

Canales de comunicación de inversores:

• Listados del mercado de valores de NASDAQ
• Seminarios web de ganancias trimestrales
• Reunión anual de accionistas

Interacciones de la agencia reguladora

Canales de comunicación regulatoria:

Agencia	Tipo de interacción	Frecuencia
FDA	Envíos de ensayos clínicos	Semestral
EMA	Autorización del mercado europeo	Anual

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

Población de pacientes de síndrome x frágil x

Población de pacientes estimada en los Estados Unidos: 100,000 personas afectadas por el síndrome de X frágil.

Grupo de edad	Predominio	Pacientes estimados
Niños (0-18 años)	1 en 4,000	25,000
Adultos (19-65 años)	1 en 7,000	75,000

Instituciones de investigación de trastorno neurológico

Instituciones de investigación objetivo clave para la terapéutica protagénica:

• Institutos Nacionales de Salud (NIH)
• Centros de investigación de neurociencia de la escuela de medicina de Harvard
• Instituto de Neurociencia de Stanford
• Departamento de Neurología de Johns Hopkins

Compañías farmacéuticas

Compañía	Presupuesto de investigación en neurodesarrollo	Interés potencial de colaboración
Pfizer	$ 500 millones	Alto
Novartis	$ 375 millones	Medio
Johnson & Johnson	$ 425 millones	Alto

Proveedores de atención médica especializados en trastornos del neurodesarrollo

Segmentos de mercado de proveedores de atención médica especializados:

• Clínicas de neurología pediátrica: 1.200 en todo el país
• Centros de tratamiento de trastorno del desarrollo: 850 en todo el país
• Clínicas de trastorno genético especializado: 450 en todo el país

Posibles inversores en sector de biotecnología

Tipo de inversor	Inversión total en biotecnología (2023)	Rango de inversión potencial
Empresas de capital de riesgo	$ 25.1 mil millones	$ 500,000 - $ 10 millones
Inversores institucionales	$ 42.3 mil millones	$ 1 millón - $ 50 millones
Capital privado	$ 18.7 mil millones	$ 2 millones - $ 25 millones

Protagenic Therapeutics, Inc. (PTIX) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Protagenic Therapeutics reportó gastos de I + D de $ 4.2 millones.

Categoría de gastos	Monto ($)
Investigación preclínica	1,350,000
Descubrimiento de drogas	1,800,000
Investigación de biología molecular	1,050,000

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para 2023 totalizaron aproximadamente $ 3.7 millones.

• Ensayos clínicos de fase I: $ 1,250,000
• Ensayos clínicos de fase II: $ 2,450,000

Protección de propiedad intelectual

Costos anuales de protección de propiedad intelectual: $ 285,000

Tipo de protección de IP	Costo ($)
Presentación de patentes	175,000
Mantenimiento de patentes	110,000

Procesos de cumplimiento y aprobación regulatoria

Gastos de cumplimiento regulatorio total para 2023: $ 620,000

• Costos de envío de la FDA: $ 340,000
• Consultoría regulatoria: $ 280,000

Personal científico e infraestructura

Costos de personal e infraestructura para 2023: $ 5.1 millones

Categoría de costos	Monto ($)
Salarios de personal científico	3,750,000
Mantenimiento de equipos de laboratorio	850,000
Costos operativos de la instalación	500,000

Protagenic Therapeutics, Inc. (PTIX) - Modelo de negocios: flujos de ingresos

Acuerdos potenciales de licencia de medicamentos futuros

A partir de 2024, la Terapéutica Protagenic aún no ha informado ingresos específicos de licencia de medicamentos. El enfoque principal de la compañía permanece en desarrollar su tubería terapéutica.

Subvenciones de investigación y financiación

Fuente de financiación	Cantidad	Año
Subvención de los Institutos Nacionales de Salud (NIH)	$350,000	2023
Subvención de Investigación de Innovación de Pequeñas Empresas (SBIR)	$250,000	2023

Asociaciones farmacéuticas estratégicas

Detalles de la asociación actual a partir de 2024:

• No se informaron las principales asociaciones farmacéuticas confirmadas
• Colaboraciones de investigación continuas con instituciones académicas

Comercialización potencial de productos terapéuticos

La tubería actual de Protagenic Therapeutics incluye:

• PTX-001: tratamiento de trastorno neurológico de estadio preclínico
• Valor de mercado potencial estimado: aún no se divulgó

Oportunidades de monetización de propiedad intelectual

Activo IP	Estado de patente	Ingresos potenciales
Plataforma de tratamiento de trastorno neurológico	Patente pendiente	No estimado
Tecnología terapéutica basada en péptidos	Patente provisional	No estimado

Financiero Overview para 2023:

• Ingresos totales: $ 600,000
• Gastos de investigación y desarrollo: $ 4.2 millones
• Pérdida neta: $ 3.8 millones

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.