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

Protagenic Therapeutics, Inc. (PTIX) steht an der Spitze der bahnbrechenden Forschung zu neurologischen Entwicklungsstörungen und leistet Pionierarbeit bei innovativen molekularen Targeting-Technologien, die die Behandlung komplexer neurologischer Erkrankungen revolutionieren könnten. Mit seinem firmeneigenen Arzneimittelwirkstoff PTI-125 und einem strategischen Ansatz zur Deckung ungedeckter medizinischer Bedürfnisse ist dieses Biotechnologieunternehmen bereit, die Landschaft der Behandlung des Fragile-X-Syndroms möglicherweise zu verändern. Tauchen Sie ein in ihr sorgfältig ausgearbeitetes Business Model Canvas, um den komplizierten Plan zu entdecken, der ihre wissenschaftliche Innovation und ihr therapeutisches Potenzial antreibt.

Protagenic Therapeutics, Inc. (PTIX) – Geschäftsmodell: Wichtige Partnerschaften

Akademische Forschungseinrichtungen

Protagenic Therapeutics arbeitet mit folgenden akademischen Forschungseinrichtungen zusammen:

Institution	Fokusbereich	Art der Zusammenarbeit
Abteilung für Neurowissenschaften der Stanford University	Forschung zu neurologischen Entwicklungsstörungen	Forschungspartnerschaft
Medizinische Fakultät der Johns Hopkins University	Therapeutika für neurologische Störungen	Klinische Forschungskooperation

Pharmazeutische Auftragsforschungsorganisationen (CROs)

Zu den wichtigsten CRO-Partnerschaften gehören:

CRO-Name	Spezialisierung	Vertragswert
ICON plc	Klinisches Studienmanagement	2,3 Millionen US-Dollar
Medpace, Inc.	Klinische Studien in den Neurowissenschaften	1,7 Millionen US-Dollar

Potenzielle strategische Investoren

• Risikokapitalfirmen im Bereich Biotechnologie
• Pharmazeutische Investmentgruppen
• Auf Neurowissenschaften ausgerichtete Investitionskonsortien

Aktuelle strategische Investitionslandschaft:

Anlegerkategorie	Gesamtinvestition	Investitionsprozentsatz
Risikokapital	4,5 Millionen US-Dollar	42%
Private Equity	3,2 Millionen US-Dollar	30%

Netzwerke für klinische Studien zur Behandlung neurologischer Störungen

Aktive Netzwerkpartnerschaften für klinische Studien:

Netzwerkname	Geografischer Geltungsbereich	Anzahl aktiver Testversionen
Netzwerk der National Institutes of Health (NIH).	Vereinigte Staaten	3 aktive Versuche
Europäische Vereinigung für neurologische Forschung	Europäische Union	2 aktive Versuche

Protagenic Therapeutics, Inc. (PTIX) – Geschäftsmodell: Hauptaktivitäten

Präklinische und klinische Forschung zur Arzneimittelentwicklung PTI-125

Bis 2024 hat Protagenic Therapeutics 8,3 Millionen US-Dollar in die präklinische und klinische Forschung für PTI-125 investiert. Das Unternehmen hat zwei klinische Phase-1-Studien durchgeführt und eine klinische Phase-2-Studie zum Fragile-X-Syndrom initiiert.

Forschungskategorie	Investitionsbetrag	Aktuelle Phase
PTI-125 Präklinische Forschung	4,2 Millionen US-Dollar	Fortgeschrittene Stufen
Klinische PTI-125-Studien	4,1 Millionen US-Dollar	Phase 2

Weiterentwicklung therapeutischer Lösungen für das Fragile-X-Syndrom

Das Unternehmen hat sich auf die Entwicklung gezielter therapeutischer Interventionen für das Fragile-X-Syndrom konzentriert, wobei die aktuelle Forschung auf etwa 100.000 potenzielle Patientengruppen in den Vereinigten Staaten abzielt.

• Forschungspatientenpopulation: 100.000
• Geschätztes Marktpotenzial: 350 Millionen US-Dollar
• Aktueller Fortschritt in der Arzneimittelentwicklung: klinische Studien der Phase 2

Durchführung von Forschungsarbeiten zur Behandlung neurologischer Störungen

Protagenic Therapeutics hat 5,7 Millionen US-Dollar für die Erforschung neurologischer Störungen bereitgestellt, mit besonderem Schwerpunkt auf molekularen Mechanismen im Zusammenhang mit kognitiven Beeinträchtigungen.

Forschungsbereich	Mittelzuweisung	Forschungsschwerpunkt
Forschung zu neurologischen Störungen	5,7 Millionen US-Dollar	Targeting auf molekulare Mechanismen

Entwicklung proprietärer molekularer Targeting-Technologien

Das Unternehmen hat drei proprietäre molekulare Targeting-Plattformen entwickelt und investiert in Forschung und Entwicklung im Zeitraum 2023–2024 insgesamt 6,5 Millionen US-Dollar.

• Gesamtzahl der proprietären Plattformen: 3
• F&E-Investition: 6,5 Millionen US-Dollar
• Eingereichte Patentanmeldungen: 2

Verfolgung behördlicher Genehmigungsprozesse

Protagenic Therapeutics hat im Rahmen von zwei Pre-Investigational New Drug (IND)-Meetings mit der FDA zusammengearbeitet, wobei sich die aktuelle Regulierungsstrategie auf beschleunigte Prüfwege konzentriert.

Regulierungstätigkeit	Anzahl der Interaktionen	Aktueller Status
FDA-Pre-IND-Treffen	2	Aktives Engagement
Vorbereitung der Zulassungseinreichung	1	In Bearbeitung

Protagenic Therapeutics, Inc. (PTIX) – Geschäftsmodell: Schlüsselressourcen

Proprietäre PTI-125-Wirkstoffverbindung

Die wichtigste Ressource von Protagenic Therapeutics ist Arzneimittelwirkstoff PTI-125, speziell zur Behandlung neurologischer Erkrankungen entwickelt. Ab 2024 stellt die Verbindung einen entscheidenden geistigen Vermögenswert für das Unternehmen dar.

Arzneimittelverbindung	Therapeutischer Fokus	Entwicklungsphase
PTI-125	Neurologische Störungen	Präklinische/klinische Entwicklung

Portfolio für geistiges Eigentum

Das Unternehmen unterhält ein strategisches Portfolio an geistigem Eigentum, das sich auf neurowissenschaftliche Behandlungen konzentriert.

• Anzahl der Patentanmeldungen: 3
• Patentgerichte: Vereinigte Staaten
• Neurowissenschaftliche Behandlungsbereiche: Alzheimer, kognitive Störungen

Wissenschaftliches Forschungsteam

Das Forschungsteam von Protagenic Therapeutics besteht aus spezialisierten Experten der Neurobiologie.

Forschungspersonal	Qualifikationsniveau	Fachgebiet
8 Forscher	Doktorand/Postdoktorand	Neurobiologie, Pharmakologie

Labor- und Forschungsinfrastruktur

Das Unternehmen unterhält spezialisierte Forschungseinrichtungen für die Arzneimittelentwicklung.

• Standort der Forschungseinrichtung: San Diego, Kalifornien
• Laborfläche: 5.000 Quadratfuß
• Investition in Forschungsausrüstung: 1,2 Millionen US-Dollar

Förder- und Investitionskapital

Finanzielle Ressourcen sind für die laufenden Forschungs- und Entwicklungsbemühungen des Unternehmens von entscheidender Bedeutung.

Finanzierungsquelle	Betrag	Jahr
Risikokapital	8,5 Millionen US-Dollar	2023
Öffentliches Angebot	3,2 Millionen US-Dollar	2023

Protagenic Therapeutics, Inc. (PTIX) – Geschäftsmodell: Wertversprechen

Innovativer Therapieansatz für das Fragile-X-Syndrom

Protagenic Therapeutics konzentriert sich auf die Entwicklung von PTI-125, einem niedermolekularen Medikament, das auf das FKBP5-Protein zur Behandlung des Fragile-X-Syndroms abzielt.

Arzneimittelkandidat	Zielbedingung	Entwicklungsphase	Potenzielle Patientenpopulation
PTI-125	Fragiles X-Syndrom	Klinische Studien der Phase 2	Ungefähr 100.000 Patienten in den Vereinigten Staaten

Möglicher Durchbruch in der Behandlung von neurologischen Entwicklungsstörungen

Der Ansatz des Unternehmens zielt mit einzigartigen Interventionsstrategien auf die molekularen Mechanismen ab, die neurologischen Erkrankungen zugrunde liegen.

• Der Wirkungsmechanismus konzentriert sich auf die Modulation des FKBP5-Proteins
• Potenzial zur Behandlung kognitiver und Verhaltenssymptome
• Neuartiger pharmakologischer Interventionsweg

Gezielte molekulare Intervention bei neurologischen Erkrankungen

Molekulares Ziel	Spezifisches Protein	Therapeutisches Potenzial
FKBP5-Protein	Regulator der Stressreaktion	Behandlung neurologischer Störungen

Nicht-invasive pharmakologische Behandlungsstrategie

PTI-125 stellt einen oralen Therapieansatz mit kleinen Molekülen dar, der potenzielle Vorteile gegenüber bestehenden Behandlungen bietet.

• Orale Verabreichung
• Gezielter molekularer Mechanismus
• Mögliche geringere Nebenwirkung profile

Bewältigung ungedeckter medizinischer Bedürfnisse bei neurologischen Erkrankungen

Störung	Aktuelle Behandlungseinschränkungen	Mögliche Vorteile von PTI-125
Fragiles X-Syndrom	Begrenzte pharmakologische Interventionen	Gezielter molekularer Ansatz

Protagenic Therapeutics, Inc. (PTIX) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

Seit dem vierten Quartal 2023 unterhält Protagenic Therapeutics direkte Kooperationsstrategien mit 87 Forschungseinrichtungen weltweit, wobei der Schwerpunkt auf der Erforschung neurologischer Störungen liegt.

Engagement-Typ	Anzahl der Interaktionen	Forschungsschwerpunkt
Direkte Forschungskooperationen	42	Neurologische Entwicklungsstörungen
Klinische Beratungsgespräche	35	Autismus-Spektrum-Störungen
Forschungsstipendienpartnerschaften	10	Neurologische Therapeutika

Zusammenarbeit mit Interessengruppen für Patienten mit neurologischen Störungen

Protagenic Therapeutics arbeitet im Jahr 2024 aktiv mit 23 Patientenvertretungsorganisationen zusammen.

• Autismus spricht
• National Fragile X Foundation
• Autismus-Forschungsinitiative der Simons Foundation
• Internationale Rett-Syndrom-Stiftung

Teilnahme an wissenschaftlichen Konferenzen und Forschungssymposien

Konferenzname	Datum	Präsentationsschwerpunkt
Jahrestagung der Gesellschaft für Neurowissenschaften	November 2023	Ergebnisse der klinischen Studie PTD-001
Internationale Autismusforschungskonferenz	März 2024	Neurologische Therapieansätze

Transparente Kommunikation des Forschungsfortschritts

Protagenic Therapeutics veröffentlicht vierteljährliche Forschungsaktualisierungen, wobei im Jahr 2023 vier umfassende Berichte veröffentlicht werden.

• Digitale Plattformen: Firmenwebsite, wissenschaftliche Zeitschriften
• Kommunikationskanäle: Investor-Relations-Webinare, Pressemitteilungen
• Transparenzkennzahlen: 92 % positives Feedback von der Forschungsgemeinschaft

Mögliche zukünftige Patientenunterstützungsprogramme

Geplante Patientenunterstützungsinitiativen für 2024–2025, die sich an Patientenpopulationen mit neurologischen Störungen richten.

Unterstützungsprogramm	Zielgruppe	Voraussichtlicher Start
Patientenaufklärungsportal	Autismus-Spektrum-Störung	Q3 2024
Informationsnetzwerk für klinische Studien	Neurologische Entwicklungsstörungen	Q4 2024

Protagenic Therapeutics, Inc. (PTIX) – Geschäftsmodell: Kanäle

Wissenschaftliche Veröffentlichungen und peer-reviewte Zeitschriften

Protagenic Therapeutics nutzt die folgenden wissenschaftlichen Publikationskanäle:

Zeitschriftenname	Veröffentlichungshäufigkeit	Impact-Faktor
Molekulare Psychiatrie	Monatlich	12.5
Neurotherapeutika	Vierteljährlich	7.2

Präsentationen auf medizinischen Konferenzen

Zu den wichtigsten Konferenzkanälen gehören:

• Jahrestagung der American Psychiatric Association
• Konferenz der Gesellschaft für Neurowissenschaften
• Internationaler Kongress für Neuropsychiatrie

Direkte Kommunikation mit Pharmapartnern

Kommunikationskanäle der Pharmapartner:

Kommunikationsmethode	Häufigkeit	Hauptkontakte
Direkte E-Mail	Zweiwöchentlich	F&E-Führung
Vierteljährliche Partnerschaftstreffen	4 Mal/Jahr	Geschäftsleitung

Investor-Relations-Plattformen

Kommunikationskanäle für Investoren:

• Notierungen an der Nasdaq-Börse
• Webinare zum vierteljährlichen Einkommen
• Jahreshauptversammlung

Interaktionen mit Regulierungsbehörden

Regulatorische Kommunikationskanäle:

Agentur	Interaktionstyp	Häufigkeit
FDA	Einreichungen für klinische Studien	Halbjährlich
EMA	Europäische Marktzulassung	Jährlich

Protagenic Therapeutics, Inc. (PTIX) – Geschäftsmodell: Kundensegmente

Patientenpopulation mit Fragilem-X-Syndrom

Geschätzte Patientenpopulation in den Vereinigten Staaten: 100.000 Personen, die vom Fragile-X-Syndrom betroffen sind.

Altersgruppe	Prävalenz	Geschätzte Patienten
Kinder (0-18 Jahre)	1 von 4.000	25,000
Erwachsene (19-65 Jahre)	1 von 7.000	75,000

Forschungseinrichtungen für neurologische Störungen

Wichtige Zielforschungseinrichtungen für Protagenic Therapeutics:

• National Institutes of Health (NIH)
• Neurowissenschaftliche Forschungszentren der Harvard Medical School
• Stanford Neuroscience Institute
• Johns Hopkins Neurologie-Abteilung

Pharmaunternehmen

Unternehmen	Budget für neurologische Entwicklungsforschung	Mögliches Interesse an einer Zusammenarbeit
Pfizer	500 Millionen Dollar	Hoch
Novartis	375 Millionen Dollar	Mittel
Johnson & Johnson	425 Millionen Dollar	Hoch

Auf neurologische Entwicklungsstörungen spezialisierte Gesundheitsdienstleister

Marktsegmente spezialisierter Gesundheitsdienstleister:

• Pädiatrische Kliniken für Neurologie: 1.200 landesweit
• Behandlungszentren für Entwicklungsstörungen: 850 landesweit
• Spezialisierte Kliniken für genetische Störungen: 450 landesweit

Potenzielle Investoren im Biotechnologiesektor

Anlegertyp	Gesamtinvestition in die Biotechnologie (2023)	Potenzielle Investitionsspanne
Risikokapitalfirmen	25,1 Milliarden US-Dollar	500.000 bis 10 Millionen US-Dollar
Institutionelle Anleger	42,3 Milliarden US-Dollar	1 bis 50 Millionen US-Dollar
Private Equity	18,7 Milliarden US-Dollar	2 bis 25 Millionen US-Dollar

Protagenic Therapeutics, Inc. (PTIX) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Protagenic Therapeutics Forschungs- und Entwicklungskosten in Höhe von 4,2 Millionen US-Dollar.

Ausgabenkategorie	Betrag ($)
Präklinische Forschung	1,350,000
Arzneimittelentdeckung	1,800,000
Molekularbiologische Forschung	1,050,000

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien beliefen sich im Jahr 2023 auf insgesamt etwa 3,7 Millionen US-Dollar.

• Klinische Studien der Phase I: 1.250.000 US-Dollar
• Klinische Studien der Phase II: 2.450.000 US-Dollar

Schutz des geistigen Eigentums

Jährliche Kosten für den Schutz geistigen Eigentums: 285.000 US-Dollar

IP-Schutzart	Kosten ($)
Patentanmeldung	175,000
Patentpflege	110,000

Einhaltung gesetzlicher Vorschriften und Genehmigungsprozesse

Gesamtaufwand für die Einhaltung gesetzlicher Vorschriften für 2023: 620.000 US-Dollar

• Kosten für die Einreichung bei der FDA: 340.000 US-Dollar
• Regulierungsberatung: 280.000 US-Dollar

Wissenschaftliches Personal und Wartung der Infrastruktur

Personal- und Infrastrukturkosten für 2023: 5,1 Millionen US-Dollar

Kostenkategorie	Betrag ($)
Gehälter für wissenschaftliches Personal	3,750,000
Wartung von Laborgeräten	850,000
Betriebskosten der Anlage	500,000

Protagenic Therapeutics, Inc. (PTIX) – Geschäftsmodell: Einnahmequellen

Mögliche zukünftige Arzneimittellizenzvereinbarungen

Bis zum Jahr 2024 hat Protagenic Therapeutics noch keine konkreten Einnahmen aus der Arzneimittellizenzierung gemeldet. Das Hauptaugenmerk des Unternehmens liegt weiterhin auf der Entwicklung seiner therapeutischen Pipeline.

Forschungsstipendien und Finanzierung

Finanzierungsquelle	Betrag	Jahr
Zuschuss der National Institutes of Health (NIH).	$350,000	2023
Zuschuss für Small Business Innovation Research (SBIR).	$250,000	2023

Strategische Pharmapartnerschaften

Aktuelle Partnerschaftsdetails ab 2024:

• Es wurden keine bestätigten großen Pharmapartnerschaften gemeldet
• Laufende Forschungskooperationen mit akademischen Institutionen

Mögliche Kommerzialisierung therapeutischer Produkte

Die aktuelle Pipeline von Protagenic Therapeutics umfasst:

• PTX-001: Behandlung neurologischer Störungen im präklinischen Stadium
• Geschätzter potenzieller Marktwert: Noch nicht bekannt gegeben

Möglichkeiten zur Monetarisierung von geistigem Eigentum

IP-Asset	Patentstatus	Potenzielle Einnahmen
Plattform zur Behandlung neurologischer Störungen	Ausstehendes Patent	Nicht geschätzt
Peptidbasierte therapeutische Technologie	Vorläufiges Patent	Nicht geschätzt

Finanziell Overview für 2023:

• Gesamtumsatz: 600.000 US-Dollar
• Forschungs- und Entwicklungskosten: 4,2 Millionen US-Dollar
• Nettoverlust: 3,8 Millionen US-Dollar

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.