Protagenic Therapeutics, Inc. (PTIX): Business Model Canvas [Jan-2025 Mis à jour]

Protagenic Therapeutics, Inc. (PTIX) est à l'avant-garde de la recherche révolutionnaire des troubles neurodéveloppementaux, des technologies de ciblage moléculaire innovantes pionnières qui pourraient révolutionner le traitement des conditions neurologiques complexes. Avec leur composé de médicament PTI-125 propriétaire et une approche stratégique pour répondre aux besoins médicaux non satisfaits, cette entreprise de biotechnologie est en vue de transformer potentiellement le paysage du traitement fragile du syndrome X. Plongez dans leur toile de modèle commercial méticuleusement conçu pour découvrir le plan complexe à l'origine de leur innovation scientifique et de leur potentiel thérapeutique.

Protagenic Therapeutics, Inc. (PTIX) - Modèle commercial: partenariats clés

Établissements de recherche universitaire

Protagenic Therapeutics collabore avec les établissements de recherche académiques suivants:

Institution	Domaine de mise au point	Type de collaboration
Département des neurosciences de l'Université de Stanford	Recherche des troubles neurodéveloppementaux	Partenariat de recherche
École de médecine de l'Université Johns Hopkins	Thérapeutique des troubles neurologiques	Collaboration de recherche clinique

Organisations de recherche sur les contrats pharmaceutiques (CRO)

Les principaux partenariats CRO comprennent:

Nom de CRO	Spécialisation	Valeur du contrat
Icône plc	Gestion des essais cliniques	2,3 millions de dollars
Medpace, Inc.	Essais cliniques en neurosciences	1,7 million de dollars

Investisseurs stratégiques potentiels

• Sociétés de capital-risque de biotechnologie
• Groupes d'investissement pharmaceutique
• Consortiums d'investissement axés sur les neurosciences

Paysage d'investissement stratégique actuel:

Catégorie d'investisseurs	Investissement total	Pourcentage d'investissement
Capital-risque	4,5 millions de dollars	42%
Capital-investissement	3,2 millions de dollars	30%

Traitement des troubles neurologiques Réseaux d'essais cliniques

Partenariats actifs du réseau d'essais cliniques:

Nom de réseau	Portée géographique	Compte d'essai actif
Réseau national des instituts de santé (NIH)	États-Unis	3 essais actifs
Association européenne de recherche neurologique	Union européenne	2 essais actifs

Protagenic Therapeutics, Inc. (PTIX) - Modèle d'entreprise: activités clés

Recherche préclinique et clinique sur le développement de médicaments PTI-125

En 2024, Protagenic Therapeutics a investi 8,3 millions de dollars dans la recherche préclinique et clinique pour le PTI-125. La société a mené 2 essais cliniques de phase 1 et a lancé 1 essai clinique de phase 2 ciblant le syndrome X fragile.

Catégorie de recherche	Montant d'investissement	Étape actuelle
PTI-125 Recherche préclinique	4,2 millions de dollars	Étapes avancées
Essais cliniques PTI-125	4,1 millions de dollars	Phase 2

Solutions thérapeutiques avancées pour le syndrome X fragile

La société s'est concentrée sur le développement d'interventions thérapeutiques ciblées pour le syndrome du X fragile, les recherches actuelles ciblant environ 100 000 populations de patients potentielles aux États-Unis.

• Recherche Population de patients: 100 000
• Potentiel du marché estimé: 350 millions de dollars
• Progrès actuel de développement des médicaments: phase 2 essais cliniques

Recherche de traitement des troubles neurologiques

Protagenic Therapeutics a alloué 5,7 millions de dollars à la recherche sur les troubles neurologiques, avec un accent spécifique sur les mécanismes moléculaires liés à la déficience cognitive.

Domaine de recherche	Allocation de financement	Focus de recherche
Recherche de troubles neurologiques	5,7 millions de dollars	Mécanisme moléculaire ciblant

Développer des technologies de ciblage moléculaire propriétaire

La société a développé 3 plateformes de ciblage moléculaire propriétaires, avec des investissements en R&D totalisant 6,5 millions de dollars en 2023-2024.

• Plates-formes propriétaires totales: 3
• Investissement en R&D: 6,5 millions de dollars
• Demandes de brevet déposées: 2

Poursuivre les processus d'approbation réglementaire

Protagenic Therapeutics s'est engagé avec la FDA grâce à 2 réunions pré-investigationnelles de médicaments sur les nouveaux médicaments (IND), avec une stratégie réglementaire actuelle axée sur les voies d'examen accélérées.

Activité réglementaire	Nombre d'interactions	État actuel
Réunions pré-ind de la FDA	2	Engagement actif
Préparation de soumission réglementaire	1	En cours

Protagenic Therapeutics, Inc. (PTIX) - Modèle commercial: Ressources clés

Composé de médicament PTI-125 propriétaire

La ressource clé de Protagenic Therapeutics est la PTI-125 composé de médicament, spécifiquement développé pour cibler les troubles neurologiques. En 2024, le composé représente un atout intellectuel critique pour la société.

Composé de médicaments	Focus thérapeutique	Étape de développement
PTI-125	Troubles neurologiques	Développement préclinique / clinique

Portefeuille de propriété intellectuelle

La société maintient un portefeuille de propriété intellectuelle stratégique axé sur les traitements des neurosciences.

• Nombre de demandes de brevet: 3
• Juridictions de brevet: États-Unis
• Domaines de traitement des neurosciences: Alzheimer, troubles cognitifs

Équipe de recherche scientifique

L'équipe de recherche de Protagenic Therapeutics comprend des experts en neurobiologie spécialisés.

Personnel de recherche	Niveau de qualification	Domaine d'expertise
8 chercheurs	PhD / post-doctoral	Neurobiologie, pharmacologie

Infrastructure de laboratoire et de recherche

La société maintient des installations de recherche spécialisées pour le développement de médicaments.

• Emplacement de l'installation de recherche: San Diego, Californie
• Travail de laboratoire en pieds carrés: 5 000 pieds carrés
• Investissement d'équipement de recherche: 1,2 million de dollars

Financement et capital d'investissement

Les ressources financières sont essentielles pour les efforts de recherche et développement en cours de l'entreprise.

Source de financement	Montant	Année
Capital-risque	8,5 millions de dollars	2023
Offre publique	3,2 millions de dollars	2023

Protagenic Therapeutics, Inc. (PTIX) - Modèle d'entreprise: propositions de valeur

Approche thérapeutique innovante pour le syndrome X fragile

Protagenic Therapeutics se concentre sur le développement de PTI-125, un médicament à petites molécules ciblant la protéine FKBP5 pour le traitement fragile du syndrome X.

Drogue	Condition cible	Étape de développement	Population potentielle de patients
PTI-125	Syndrome X fragile	Essais cliniques de phase 2	Environ 100 000 patients aux États-Unis

Percée potentielle dans le traitement des troubles neurodéveloppementaux

L'approche de l'entreprise cible les mécanismes moléculaires sous-jacents aux conditions neurologiques avec des stratégies d'intervention uniques.

• Le mécanisme d'action se concentre sur la modulation des protéines FKBP5
• Potentiel pour lutter contre les symptômes cognitifs et comportementaux
• Nouvelle voie d'intervention pharmacologique

Intervention moléculaire ciblée pour les conditions neurologiques

Cible moléculaire	Protéine spécifique	Potentiel thérapeutique
Protéine FKBP5	Régulateur de réponse au stress	Traitement des troubles neurologiques

Stratégie de traitement pharmacologique non invasive

Le PTI-125 représente une approche thérapeutique orale de petites molécules avec des avantages potentiels par rapport aux traitements existants.

• Administration orale
• Mécanisme moléculaire ciblé
• Effet secondaire réduit potentiel profile

Répondre aux besoins médicaux non satisfaits dans les troubles neurologiques

Trouble	Limites de traitement actuelles	PTI-125 Avantages potentiels
Syndrome X fragile	Interventions pharmacologiques limitées	Approche moléculaire ciblée

Protagenic Therapeutics, Inc. (PTIX) - Modèle d'entreprise: relations avec les clients

Engagement direct avec la communauté de la recherche médicale

Depuis le quatrième trimestre 2023, la thérapeutique protagénique maintient des stratégies d'engagement directes avec 87 institutions de recherche dans le monde, en se concentrant sur la recherche sur les troubles neurologiques.

Type d'engagement	Nombre d'interactions	Focus de recherche
Collaborations de recherche directes	42	Troubles neurodéveloppementaux
Consultations de conseil clinique	35	Troubles du spectre autistique
Partenariats de subvention de recherche	10	Thérapeutique neurologique

Collaboration avec des groupes de défense des patients en troubles neurologiques

Protagenic Therapeutics collabore activement avec 23 organisations de défense des patients en 2024.

• L'autisme parle
• Fondation nationale fragile X
• Initiative de recherche sur l'autisme de la Simons Foundation
• Fondation internationale du syndrome de Rett

Participation du symposium de conférence scientifique et de recherche

Nom de conférence	Date	Focus de présentation
Réunion annuelle de la Société des Neurosciences	Novembre 2023	Résultats des essais cliniques PTD-001
Conférence internationale de recherche sur l'autisme	Mars 2024	Approches thérapeutiques neurologiques

Communication transparente des progrès de la recherche

Protagenic Therapeutics publie des mises à jour trimestrielles de recherche, avec 4 rapports complets publiés en 2023.

• Plates-formes numériques: Site Web de l'entreprise, revues scientifiques
• Canaux de communication: Webinaires des relations avec les investisseurs, communiqués de presse
• Métriques de transparence: 92% de commentaires positifs de la communauté de la recherche

Programmes potentiels de soutien aux patients

Initiatives de soutien aux patients prévus pour 2024-2025 Ciblage des populations de patients des troubles neurologiques.

Programme de soutien	Population cible	Lancement estimé
Portail de formation des patients	Trouble du spectre d'autisme	Q3 2024
Réseau d'information des essais cliniques	Troubles neurodéveloppementaux	Q4 2024

Protagenic Therapeutics, Inc. (PTIX) - Modèle d'entreprise: canaux

Publications scientifiques et revues à comité de lecture

Protagenic Therapeutics utilise les canaux de publication scientifique suivants:

Nom de journal	Fréquence de publication	Facteur d'impact
Psychiatrie moléculaire	Mensuel	12.5
Neurothérapie	Trimestriel	7.2

Présentations de la conférence médicale

Les canaux clés de la conférence comprennent:

• Réunion annuelle de l'American Psychiatric Association
• Conférence de la Société pour les neurosciences
• Congrès international de neuropsychiatrie

Communication directe avec les partenaires pharmaceutiques

Canaux de communication des partenaires pharmaceutiques:

Méthode de communication	Fréquence	Contacts primaires
E-mail direct	Bihebdomadaire	Leadership de la R&D
Réunions de partenariat trimestriel	4 fois / an	Direction

Plateformes de relations avec les investisseurs

Canaux de communication des investisseurs:

• Listes de marchés boursiers du NASDAQ
• Webinaires de résultats trimestriels
• Réunion des actionnaires annuelle

Interactions d'agence de réglementation

Canaux de communication réglementaires:

Agence	Type d'interaction	Fréquence
FDA	Soumissions d'essais cliniques	Semestriel
Ema	Autorisation du marché européen	Annuel

Protagenic Therapeutics, Inc. (PTIX) - Modèle d'entreprise: segments de clientèle

Population de patients du syndrome X fragile

Population estimée des patients aux États-Unis: 100 000 personnes touchées par le syndrome X fragile.

Groupe d'âge	Prévalence	Patients estimés
Enfants (0-18 ans)	1 sur 4 000	25,000
Adultes (19-65 ans)	1 sur 7 000	75,000

Institutions de recherche sur les troubles neurologiques

Institutions de recherche cibles clés pour la thérapeutique protagénique:

• National Institutes of Health (NIH)
• Centres de recherche en neurosciences de la Harvard Medical School
• Stanford Neuroscience Institute
• Département de neurologie Johns Hopkins

Sociétés pharmaceutiques

Entreprise	Budget de recherche neurodéveloppementale	Intérêt potentiel de collaboration
Pfizer	500 millions de dollars	Haut
Novartis	375 millions de dollars	Moyen
Johnson & Johnson	425 millions de dollars	Haut

Fournisseurs de soins de santé spécialisés dans les troubles neurodéveloppementaux

Segments de marché spécialisés des fournisseurs de soins de santé:

• Cliniques de neurologie pédiatrique: 1 200 à l'échelle nationale
• Centres de traitement des troubles du développement: 850 à l'échelle nationale
• Cliniques spécialisées des troubles génétiques: 450 à l'échelle nationale

Investisseurs potentiels dans le secteur de la biotechnologie

Type d'investisseur	Investissement total de biotechnologie (2023)	Gamme d'investissement potentielle
Sociétés de capital-risque	25,1 milliards de dollars	500 000 $ - 10 millions de dollars
Investisseurs institutionnels	42,3 milliards de dollars	1 million de dollars - 50 millions de dollars
Capital-investissement	18,7 milliards de dollars	2 millions de dollars - 25 millions de dollars

Protagenic Therapeutics, Inc. (PTIX) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Protagenic Therapeutics a déclaré des dépenses de R&D de 4,2 millions de dollars.

Catégorie de dépenses	Montant ($)
Recherche préclinique	1,350,000
Découverte de médicaments	1,800,000
Recherche de biologie moléculaire	1,050,000

Coûts de gestion des essais cliniques

Les dépenses d'essai cliniques pour 2023 ont totalisé environ 3,7 millions de dollars.

• Essais cliniques de phase I: 1 250 000 $
• Essais cliniques de phase II: 2 450 000 $

Protection de la propriété intellectuelle

Frais de protection de la propriété intellectuelle annuelle: 285 000 $

Type de protection IP	Coût ($)
Dépôt de brevet	175,000
Entretien de brevets	110,000

Processus de conformité et d'approbation réglementaires

Total des frais de conformité réglementaire pour 2023: 620 000 $

• Coûts de soumission de la FDA: 340 000 $
• Conseil réglementaire: 280 000 $

Maintenance scientifique du personnel et des infrastructures

Coûts de personnel et d'infrastructure pour 2023: 5,1 millions de dollars

Catégorie de coûts	Montant ($)
Salaires du personnel scientifique	3,750,000
Entretien de l'équipement de laboratoire	850,000
Coûts opérationnels de l'installation	500,000

Protagenic Therapeutics, Inc. (PTIX) - Modèle d'entreprise: Strots de revenus

Accords potentiels de licence de médicament potentiel

En 2024, Protagenic Therapeutics n'a pas encore déclaré de revenus spécifiques de licence de médicament. L'objectif principal de l'entreprise reste sur le développement de son pipeline thérapeutique.

Subventions et financement de recherche

Source de financement	Montant	Année
Subvention des National Institutes of Health (NIH)	$350,000	2023
Grant de recherche sur l'innovation des petites entreprises (SBIR)	$250,000	2023

Partenariats pharmaceutiques stratégiques

Détails du partenariat actuel à partir de 2024:

• Aucun partenariat pharmaceutique confirmé signalé
• Collaborations de recherche en cours avec des établissements universitaires

Commercialisation potentielle des produits thérapeutiques

Le pipeline actuel de Protagenic Therapeutics comprend:

• PTX-001: Traitement des troubles neurologiques du stade préclinique
• Valeur marchande potentielle estimée: non encore divulguée

Opportunités de monétisation de la propriété intellectuelle

Actif IP	Statut de brevet	Revenus potentiels
Plate-forme de traitement des troubles neurologiques	Brevet en attente	Non estimé
Technologie thérapeutique à base de peptides	Brevet provisoire	Non estimé

Financier Overview pour 2023:

• Revenu total: 600 000 $
• Dépenses de recherche et de développement: 4,2 millions de dollars
• Perte nette: 3,8 millions de dollars

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.