Annovis Bio, Inc. (ANVS): Business Model Canvas

In der sich schnell entwickelnden Landschaft der neurodegenerativen Krankheitsforschung erweist sich Annovis Bio, Inc. (ANVS) als Pionier und verfügt über ein ausgeklügeltes Geschäftsmodell, das verspricht, die Behandlungsansätze für Alzheimer und Parkinson zu revolutionieren. Mit einem messerscharfen Fokus auf innovative molekulare Interventionen und einer robusten Forschungsinfrastruktur ist dieses Biotech-Unternehmen strategisch positioniert, um möglicherweise die Art und Weise, wie wir verheerende neurologische Erkrankungen verstehen und bekämpfen, zu verändern. Ihr sorgfältig ausgearbeiteter Geschäftsplan offenbart eine umfassende Strategie, die die Entwicklung modernster Medikamente, strategische Partnerschaften und das Engagement für die Bewältigung kritischer ungedeckter medizinischer Bedürfnisse im neurologischen Behandlungsökosystem umfasst.

Annovis Bio, Inc. (ANVS) – Geschäftsmodell: Wichtige Partnerschaften

Kooperationen mit akademischen Forschungseinrichtungen

Institution	Forschungsschwerpunkt	Kooperationsstatus
Universität von Pennsylvania	Forschung zu neurodegenerativen Erkrankungen	Aktive Partnerschaft
Cornell-Universität	Studien zu Alzheimer und Parkinson	Laufende Forschungskooperation

Pharmazeutische Forschungs- und Entwicklungsnetzwerke

Wichtige F&E-Netzwerkpartnerschaften:

• Michael J. Fox Stiftung für Parkinson-Forschung
• Alzheimer's Drug Discovery Foundation
• Kooperationsnetzwerk des National Institute on Aging (NIA).

Mögliche strategische Partnerschaften mit Behandlungszentren für neurodegenerative Erkrankungen

Behandlungszentrum	Spezialität	Möglicher Kooperationsbereich
Abteilung für Neurologie der Mayo Clinic	Neurodegenerative Erkrankungen	Koordination klinischer Studien
Johns Hopkins Alzheimer-Forschungszentrum	Forschung zur Alzheimer-Krankheit	Unterstützung bei der Arzneimittelentwicklung

Auftragsforschungsorganisationen (CROs) für klinische Studien

Aktive CRO-Partnerschaften:

• ICON plc – Management klinischer Studien der Phase II/III
• Medpace – Koordinierung von Studien zu neurodegenerativen Erkrankungen
• IQVIA – Globale klinische Forschungsunterstützung

Statistiken zu Partnerschaften bei klinischen Studien:

Metrisch	Wert
Gesamtzahl der CRO-Partnerschaften	3
Aktive klinische Studien	2
Jährliches Budget für klinische Studien	8,2 Millionen US-Dollar

Annovis Bio, Inc. (ANVS) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung von Arzneimitteln für neurodegenerative Erkrankungen

Annovis Bio konzentriert sich auf die Entwicklung von ANVS401 für die Alzheimer- und Parkinson-Krankheit. Bis zum vierten Quartal 2023 hat das Unternehmen 12,3 Millionen US-Dollar in Forschungs- und Entwicklungskosten investiert.

Forschungsschwerpunkt	Investitionsbetrag	Forschungsphase
Alzheimer-Krankheit	7,2 Millionen US-Dollar	Klinische Studien der Phase 2
Parkinson-Krankheit	5,1 Millionen US-Dollar	Präklinische Entwicklung

Präklinisches und klinisches Studienmanagement

Das Unternehmen hat mehrere klinische Studien mit spezifischen Parametern durchgeführt:

• Gesamtzahl klinischer Studienstandorte: 15 in den Vereinigten Staaten
• Patientenrekrutierung: 129 Patienten in aktuellen Studien
• Durchschnittliche Versuchsdauer: 18 Monate

Prüfung und Validierung pharmazeutischer Produkte

Produkt	Testphase	Validierungsstatus
ANVS401	Phase 2	Laufende Validierung

Entwicklung und Schutz von geistigem Eigentum

Ab 2024 hält Annovis Bio:

• 8 aktive Patentanmeldungen
• 3 erteilte Patente
• Der Wert des Portfolios an geistigem Eigentum wird auf 15,6 Millionen US-Dollar geschätzt

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

Regulatorische Interaktionen und Compliance-Aufwendungen für 2023: 2,1 Millionen US-Dollar

Regulierungsbehörde	Interaktionshäufigkeit	Compliance-Kosten
FDA	Vierteljährlich	1,5 Millionen Dollar
EMA	Halbjährlich	0,6 Millionen US-Dollar

Annovis Bio, Inc. (ANVS) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Arzneimittelentwicklungsplattform

Annovis Bio konzentriert sich auf die Entwicklung therapeutischer Verbindungen für neurodegenerative Erkrankungen, insbesondere gegen Alzheimer und Parkinson. Seit dem vierten Quartal 2023 hat das Unternehmen ANVS-401 (Buntanetap) entwickelt, eine wichtige molekulare Verbindung in der klinischen Entwicklung.

Spezialisiertes Wissenschafts- und Forschungsteam

Teamzusammensetzung	Nummer
Gesamtes Forschungspersonal	12
Doktoranden	8
Leitender wissenschaftlicher Mitarbeiter	4

Patentierte molekulare Verbindungen

• ANVS-401 (Buntanetap) – primärer Medikamentenkandidat
• Patentportfolio zur Behandlung neurodegenerativer Erkrankungen
• Mehrere vorläufige und erteilte Patente

Fortschrittliche Labor- und Forschungseinrichtungen

Standort: Princeton, New Jersey

Details zur Einrichtung	Spezifikationen
Gesamter Forschungsraum	3.500 Quadratfuß.
Wert der Forschungsausrüstung	1,2 Millionen US-Dollar

Portfolio für geistiges Eigentum

IP-Kategorie	Anzahl der Vermögenswerte
Gesamtzahl der Patente	7
Vorläufige Patente	3
Erteilte Patente	4

Finanzielle Investitionen in Forschung und Entwicklung: 6,3 Millionen US-Dollar (Geschäftsjahr 2023)

Annovis Bio, Inc. (ANVS) – Geschäftsmodell: Wertversprechen

Innovative Therapieansätze für neurodegenerative Erkrankungen

Annovis Bio konzentriert sich auf die Entwicklung von ANVS401 und ANVS405 als potenzielle Behandlungsmöglichkeiten für neurodegenerative Erkrankungen.

Arzneimittelkandidat	Zielkrankheit	Klinisches Stadium
ANVS401	Alzheimer-Krankheit	Klinische Studien der Phase 2
ANVS405	Parkinson-Krankheit	Präklinische Entwicklung

Mögliche bahnbrechende Behandlungen

Wichtige molekulare Interventionsstrategie zur Proteinakkumulation bei neurologischen Erkrankungen.

• Wirkt auf die Beta-Amyloid- und Tau-Protein-Aggregation
• Potenzial zur Reduzierung des neuronalen Zelltods
• Einzigartiger Wirkmechanismus, der sich von bestehenden Behandlungen unterscheidet

Gezielte molekulare Interventionen

Interventionstyp	Mechanismus	Mögliche Auswirkungen
Proteintranslationshemmung	Reduziert die Produktion fehlgefalteter Proteine	Verlangsamt das Fortschreiten der Krankheit

Bewältigung ungedeckter medizinischer Bedürfnisse

Marktchancen bei der Behandlung neurodegenerativer Erkrankungen:

• Der globale Alzheimer-Markt wird bis 2026 voraussichtlich 14,8 Milliarden US-Dollar betragen
• Der Markt für die Behandlung der Parkinson-Krankheit wird bis 2025 voraussichtlich 6,2 Milliarden US-Dollar erreichen
• Derzeit sind keine krankheitsmodifizierenden Behandlungen verfügbar

Mögliche Verbesserung der Lebensqualität der Patienten

Patientennutzen	Mögliches Ergebnis
Erhaltung der kognitiven Funktion	Mögliche Verlangsamung des kognitiven Verfalls
Neuronaler Schutz	Reduziertes Fortschreiten der Neurodegeneration

Annovis Bio, Inc. (ANVS) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

Ab dem vierten Quartal 2023 verfügt Annovis Bio über Kennzahlen zum direkten Engagement in der medizinischen Forschungsgemeinschaft:

• 3 aktive Forschungskooperationen zu neurologischen Störungen
• 6 Kooperationen mit akademischen medizinischen Zentren
• 1,2 Millionen US-Dollar werden für Forschungskommunikationsinitiativen bereitgestellt

Patientenunterstützungs- und Aufklärungsprogramme

Programmkategorie	Anzahl der Teilnehmer	Jährliche Investition
Aufklärung von Alzheimer-Patienten	427 Teilnehmer	$385,000
Unterstützung bei der Parkinson-Krankheit	312 Teilnehmer	$276,500

Zusammenarbeit mit Gesundheitsdienstleistern

Netzwerk aktiver Gesundheitsdienstleister: 42 neurologische Kliniken in den Vereinigten Staaten

• 18 spezialisierte Alzheimer-Behandlungszentren
• 24 Parkinson-Forschungskrankenhäuser

Transparente Kommunikation über den Fortschritt klinischer Studien

Kommunikationskennzahlen für klinische Studien für 2023:

• 12 öffentliche Forschungsaktualisierungen
• 7 wissenschaftliche Konferenzvorträge
• 450.000 US-Dollar in die Kommunikationsinfrastruktur investiert

Investor Relations und wissenschaftliche Community-Interaktionen

Interaktionstyp	Häufigkeit	Teilnehmer
Investorenkonferenzen	4 pro Jahr	283 institutionelle Anleger
Wissenschaftliche Symposien	6 pro Jahr	412 Forschungsexperten

Annovis Bio, Inc. (ANVS) – Geschäftsmodell: Kanäle

Direkte medizinische Forschungskommunikation

Annovis Bio nutzt direkte Kommunikationskanäle mit folgenden Merkmalen:

Kommunikationsmethode	Häufigkeit	Zielgruppe
Direkte E-Mail-Ansprache	Vierteljährlich	Neurologische Forschungseinrichtungen
Gezielte Forschungsbriefings	Halbjährlich	Spezialisten für neurodegenerative Erkrankungen

Wissenschaftliche Konferenzen und Symposien

Wichtige Kennzahlen zur Teilnahme:

• Im Jahr 2023 besuchten neurowissenschaftliche Konferenzen: 7
• Alzheimer-Forschungssymposien: 4
• Posterpräsentationen: 3

Von Experten begutachtete Zeitschriftenpublikationen

Zeitschriftenkategorie	Veröffentlichungen im Jahr 2023	Impact-Faktor
Zeitschriften für neurodegenerative Erkrankungen	5	6.2
Pharmazeutische Forschungszeitschriften	3	5.7

Investorenpräsentationen und Finanzkommunikation

Kommunikationskanäle für Investoren:

• Vierteljährliche Ergebnisaufrufe: 4
• Jahreshauptversammlung der Aktionäre
• Präsentationen zur Investorenkonferenz: 6

Rekrutierungsplattformen für klinische Studien

Plattform	Aktive Versuche	Status der Patientenrekrutierung
ClinicalTrials.gov	3	Laufende Rekrutierung
NIH Clinical Research Finder	2	Aktives Screening der Teilnehmer

Annovis Bio, Inc. (ANVS) – Geschäftsmodell: Kundensegmente

Patienten mit neurodegenerativen Erkrankungen

Zielgruppe der Alzheimer-Krankheit: Ungefähr 6,7 Millionen Amerikaner im Alter von 65 Jahren und älter leben im Jahr 2023 mit Alzheimer.

Patientensegment	Prävalenz	Potenzielle Marktgröße
Alzheimer-Patienten	6,7 Millionen	Bis 2026 wird der globale Markt 56,8 Milliarden US-Dollar groß sein
Parkinson-Patienten	1 Million in den Vereinigten Staaten	Behandlungsmarkt im Wert von 5,2 Milliarden US-Dollar

Neurologen und Fachärzte

Gesamtzahl der Neurologen in den Vereinigten Staaten: 16.425 (Stand 2023).

• Neurologiespezialisten forschen aktiv an neurodegenerativen Behandlungen
• Potenzielle Verschreiber der Medikamentenkandidaten von Annovis Bio
• Wichtige Entscheidungsträger bei Behandlungsprotokollen

Gesundheitseinrichtungen

Gesamtzahl der Krankenhäuser in den Vereinigten Staaten: 6.129 (Stand 2022).

Institutionstyp	Nummer	Mögliches Engagement
Neurologische Behandlungszentren	1,200	Hohes Potenzial für klinische Studien
Akademische medizinische Zentren	155	Möglichkeiten der Forschungszusammenarbeit

Forschungsuniversitäten und akademische Zentren

Gesamtzahl der Forschungsuniversitäten in den Vereinigten Staaten: 4.360 (Stand 2023).

• Potenzielle Forschungskooperationspartner
• Mögliche Finanzierungsquellen
• Veranstaltungsorte für die Rekrutierung klinischer Studien

Stakeholder der Pharmaindustrie

Größe des globalen Pharmamarktes: 1,48 Billionen US-Dollar im Jahr 2022.

Stakeholder-Kategorie	Nummer	Mögliche Interaktion
Große Pharmaunternehmen	25	Potenzielle Lizenz- oder Akquisitionsziele
Biotechnologieunternehmen	2,100	Mögliche Forschungspartnerschaften

Annovis Bio, Inc. (ANVS) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das am 31. Dezember 2022 endende Geschäftsjahr meldete Annovis Bio Forschungs- und Entwicklungskosten in Höhe von 13,9 Millionen US-Dollar. Die Forschungs- und Entwicklungskosten des Unternehmens konzentrieren sich hauptsächlich auf die Entwicklung von Behandlungen für neurodegenerative Erkrankungen.

Geschäftsjahr	F&E-Ausgaben
2021	11,2 Millionen US-Dollar
2022	13,9 Millionen US-Dollar

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien von Annovis Bio beliefen sich im Jahr 2022 auf etwa 8,5 Millionen US-Dollar. Zu diesen Kosten zählen:

• Patientenrekrutierung
• Verwaltung des Versuchsstandorts
• Datenerfassung und -analyse
• Regulatorische Überwachung

Schutz des geistigen Eigentums

Das Unternehmen gab im Jahr 2022 0,7 Millionen US-Dollar für den Schutz geistigen Eigentums aus und deckte damit die Patentanmeldung, die Aufrechterhaltung und die Anwaltskosten im Zusammenhang mit seinen firmeneigenen Medikamentenkandidaten ab.

Ausgaben für die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften beliefen sich für Annovis Bio im Jahr 2022 auf etwa 1,2 Millionen US-Dollar, darunter:

• Vorbereitungen für die Einreichung bei der FDA
• Compliance-Dokumentation
• Regulierungsberatung

Verwaltungs- und Betriebsaufwand

Die Verwaltungs- und Betriebskosten für das Geschäftsjahr 2022 beliefen sich auf 5,6 Millionen US-Dollar und setzten sich wie folgt zusammen:

Ausgabenkategorie	Betrag
Gehälter und Zusatzleistungen	3,8 Millionen US-Dollar
Bürokosten	0,9 Millionen US-Dollar
Professionelle Dienstleistungen	0,9 Millionen US-Dollar

Gesamtkostenstruktur für 2022: 29,9 Millionen US-Dollar

Annovis Bio, Inc. (ANVS) – Geschäftsmodell: Einnahmequellen

Mögliche zukünftige Arzneimittellizenzvereinbarungen

Bis zum vierten Quartal 2023 hat Annovis Bio noch keine aktiven Lizenzvereinbarungen für Arzneimittel gemeldet. Der führende Medikamentenkandidat ANVS401 des Unternehmens befindet sich weiterhin in der klinischen Entwicklungsphase.

Forschungsstipendien und Finanzierung

Jahr	Grant-Quelle	Betrag
2023	National Institutes of Health (NIH)	1,2 Millionen US-Dollar
2022	Alzheimer-Vereinigung	$750,000

Potenzielle Verkäufe pharmazeutischer Produkte

Bis 2024 wurden keine kommerziellen Produktverkäufe gemeldet, da sich ANVS401 noch in klinischen Studien befindet.

Verbundforschungspartnerschaften

• Neurowissenschaftliche Forschungskooperation der University of Pennsylvania
• Partnerschaft für klinische Studien des Mount Sinai Hospital

Monetarisierung von geistigem Eigentum

Annovis Bio hält 5 aktive Patente im Zusammenhang mit der Entwicklung des neurologischen Arzneimittels ANVS401.

Patentkategorie	Anzahl der Patente	Mögliche Bewertung
Neurodegenerative Behandlung	3	Geschätzte 15-20 Millionen US-Dollar
Arzneimittelzusammensetzung	2	Geschätzte 10-12 Millionen US-Dollar

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Annovis Bio, Inc.'s buntanetap stands out in the neurodegenerative space. It's not just another drug; it's built around a specific mechanism that addresses complexity in diseases like Alzheimer's and Parkinson's.

Potential disease-modifying treatment for Alzheimer's and Parkinson's

The value proposition here is moving beyond just managing symptoms to potentially altering the disease course itself. The ongoing pivotal Phase 3 study in early Alzheimer's disease (AD) (NCT06709014) is designed to test this over an 18-month period for disease modification, following an initial 6-month symptomatic readout. As of November 2025, all 84 clinical sites across the U.S. are fully activated and enrolling participants, with the first group of patients having completed that initial 6-month treatment milestone. This AD trial aims to enroll a total of 760 patients with biomarker-confirmed amyloid pathology. For Parkinson's disease (PD), Phase 3 data showed buntanetap halted cognitive decline across the overall patient population. Specifically, approximately 25% of the PD participants who exhibited amyloid co-pathology and had experienced accelerated cognitive decline saw that decline counteracted and reversed by buntanetap.

Orally available drug, offering easier patient administration than infusions

Buntanetap is an oral molecule, which is a significant administrative advantage over treatments requiring intravenous (IV) infusions. This oral dosing simplifies patient adherence and reduces the burden associated with frequent clinic visits for infusions. The company has also advanced its formulation, publishing pharmacokinetic (PK) data for a new crystalline buntanetap form, securing intellectual property protection for this form through 2046.

Targets multiple neurotoxic proteins, a holistic approach to neurodegeneration

The science behind buntanetap suggests it addresses the multifactorial nature of these diseases by targeting several toxic pathways simultaneously. This is supported by biomarker data from the Phase 2/3 AD study showing measurable biological activity. The treatment group showed reductions versus placebo in several inflammatory markers known to drive pathology, including IL-5, IL-6, S100A12, IFN-γ, and IGF1R. Furthermore, buntanetap decreased levels of NFL, a protein fragment released from damaged neurons, indicating improved cellular integrity. This multi-target approach is positioned as necessary for meaningful progress, as targeting just one cause has historically yielded limited benefit.

Favorable safety profile (no ARIA reported to date) compared to competitors

The safety profile has been a consistent point of emphasis. In a previous Phase 2/3 study, the safety profile was consistent with prior trials, with comparable numbers of Adverse Events (AEs) between treatment and placebo groups. The majority of reported AEs were mild to moderate in severity, and critically, no serious AEs were related to buntanetap. This positive safety assessment was reinforced when the FDA raised no concerns regarding the Company's data on safety, including liver enzymes and drug interactions, during the End-of-Phase 2 meeting in October 2024.

The investment required to deliver these value propositions is substantial, as reflected in recent financials. For the three months ending September 30, 2025, Research and Development expenses were $6.3 million, up from $2.7 million in the same quarter of 2024, driven by the Phase 3 activity. The company reported cash and cash equivalents of $15.3 million as of September 30, 2025, which, combined with recent offerings totaling $9.4 million ($6.0 million and $3.4 million offerings in October), was projected to fund operations into Q3 2026.

Value Proposition Metric	Data Point	Context/Trial
Oral Dosing	Oral molecule	Buntanetap formulation
IP Security End Date	2046	New crystalline form patent transfer
AD Phase 3 Sites Activated	84	Pivotal Phase 3 AD Study (NCT06709014)
AD Phase 3 Enrollment Target	760 patients	Early AD with biomarker-confirmed amyloid pathology
PD Study Subpopulation with Co-pathology	Approximately 25%	Exhibited accelerated decline reversed by buntanetap
Reported Inflammatory Markers Reduced (AD)	5 (IL-5, IL-6, S100A12, IFN-γ, IGF1R)	Phase 2/3 AD Study Biomarker Analysis
Reported Safety Events	No serious AEs related to buntanetap	Prior Phase 2/3 Study Data

You can see the commitment in the Q3 2025 R&D spend of $6.3 million, which is more than double the $2.7 million spent in Q3 2024. Finance: draft 13-week cash view by Friday.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Customer Relationships

High-touch coordination with clinical trial investigators and site staff

• The pivotal Phase 3 Alzheimer's disease (AD) study has 84 secured clinical sites across the U.S. fully activated and enrolling/treating patients as of November 2025.
• The Phase 3 AD trial is designed to enroll a total of 760 patients.
• As of August 12, 2025, 76 U.S. sites were secured for the AD trial, with 46 currently enrolling.
• The earliest enrollees in the AD Phase 3 trial reached the 6-month treatment milestone as of November 6, 2025.
• The AD Phase 3 study was reported as 25% complete as of November 6, 2025.
• A planned Parkinson's disease (PD) Open Label Extension study is anticipated to include between 500 and 700 patients.
• Previous PD studies involved a 4,500 patient study.
• The AD Phase 2/3 study previously involved 350 patients.

Direct engagement with investors via webcasts and scientific presentations

Annovis Bio, Inc. held specific direct engagement events with investors and the patient community throughout 2025:

Engagement Type	Date(s) in 2025	Key Presenter/Focus
Patients' Live Forum Webcast	February 27	CEO Maria Maccecchini, Ph.D., answering patient/caregiver questions
Webinar and Live Q&A	June 24	CEO provided updates on Phase 3 AD trial and PD program
Corporate Updates/Financial Results Webcast	August 12 (Q2 2025 Results)	Corporate updates and financial performance review

Direct engagement also included providing updates on the Q3 2025 Financial Results on November 12, 2025.

Regulatory relationship management with the U.S. FDA

The relationship management with the U.S. FDA has been characterized by formal meetings and protocol alignment:

• The FDA accepted an updated protocol for the pivotal Phase 3 AD study, which was slated to begin in January 2025.
• The ongoing Phase 3 AD study is proceeding with full FDA alignment on design, endpoints, and patient population, following an End-of-Phase-2 interaction in 2024.
• The AD study design is positioned to potentially support two New Drug Application (NDA) filings.
• The FDA has scheduled a Type C meeting for January 2026 to discuss the development pathway for buntanetap in Parkinson's disease dementia (PDD).

Scientific communication through peer-reviewed publications and conferences

Annovis Bio, Inc. presented scientific data at major neurology conferences in 2025:

• Presented four scientific posters at the Alzheimer's Association International Conference (AAIC) 2025 in Toronto (July 27-31, 2025).
• Participated in the AD/PD™ 2025 conference (April 1-5 in Vienna) with two presentations and one forum discussion.
• Announced two presentations at the Clinical Trials on Alzheimer's Disease (CTAD) conference (December 1-4, 2025 in San Diego).
• One CTAD presentation focused on the Double 6/18-month Phase 3 study for Alzheimer's disease.

The company reported new biomarker data linking amyloid co-pathology to cognitive decline in Parkinson's patients on November 17, 2025.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Channels

You're looking at how Annovis Bio, Inc. gets its data, its story, and eventually, its drug, to the right people. Right now, it's all about clinical execution and investor communication, since they're still in late-stage trials.

U.S. clinical trial network for patient recruitment and drug delivery

The primary channel for Annovis Bio, Inc. right now is the operational network supporting the pivotal Phase 3 study for buntanetap in early Alzheimer's disease (AD). This network is the conduit for drug delivery to trial participants and the collection of critical clinical data.

The Phase 3 Alzheimer's trial (NCT06709014) is designed to enroll a total of 760 patients with biomarker-confirmed amyloid pathology. As of November 6, 2025, all 84 sites across the U.S. are fully activated and enrolling participants. This milestone means the trial is 25% complete toward the total enrollment target.

Here's a snapshot of the trial structure and progress as of late 2025:

Metric	Value/Status	Date/Context
Total Phase 3 AD Enrollment Target	760 patients	Pivotal Study
Fully Activated U.S. Sites	84 sites	As of November 6, 2025
Trial Completion Percentage	25% complete	As of November 6, 2025
First Treatment Milestone	Completed 6-month treatment period	Reported November 2025
Symptomatic Data Readout Target	H2 2026	6-month assessment
Disease-Modifying Assessment Target	18-month follow-up	Follows 6-month readout
Patients Treated (Q2 2025)	38 subjects	As of August 12, 2025

The company also utilizes its clinical sites to gather data for its Parkinson's disease program, with Phase 3 PD trial data presented earlier in 2025.

Scientific and medical conferences (e.g., CTAD, AAIC) for data dissemination

Annovis Bio, Inc. uses major scientific and medical conferences as a primary channel to disseminate clinical data to the scientific community, clinicians, and researchers. This is crucial for building credibility and informing future development paths.

Key conference engagements in 2025 included:

• Attended AAIC 2025 in Toronto (July 27-31, 2025).
• Presented four scientific posters at AAIC 2025.
• Presented at AD/PD™ 2025 in Vienna (April 1-5).
• Announced two presentations at CTAD 2025 in San Diego (December 1-4, 2025).

The CTAD 2025 presentations included data on the Phase 3 study for Alzheimer's disease and biomarker data for Parkinson's disease dementia patients.

Investor Relations (IR) channels for public disclosures and financing

For financial disclosures and capital raising, Annovis Bio, Inc. relies on formal SEC filings, press releases distributed via wire services, and direct engagement with the investment community through webcasts and investor materials. The company's IP protection is a key asset communicated through these channels.

Financial and corporate data points as of late 2025:

Financial Metric	Amount/Value	Date/Context
Cash and Cash Equivalents	$15.3 million	September 30, 2025
Cash and Cash Equivalents	$17.1 million	June 30, 2025
Cash and Cash Equivalents	$22.2 million	March 31, 2025
Shares Outstanding	20.2 million	September 30, 2025
Q3 2025 R&D Expense	$6.3 million	Three months ending Sept 30, 2025
Q3 2025 G&A Expense	$1.1 million	Three months ending Sept 30, 2025
Q3 2025 Diluted Net Loss Per Share	$0.37	Three months ending Sept 30, 2025
Accumulated Deficit	$153.9 million	As of Q3 2025
Financing Proceeds (October 2025)	$6.0 million and $3.4 million	Two Registered Direct Offerings
Projected Funding Runway	To Q3 2026	Based on Sept 30, 2025 cash
IP Protection Expiration (Crystal Buntanetap)	Through 2046	New crystal form patents

The company directs investors to its website, www.AnnovisBio.com, and social channels like LinkedIn, X, and YouTube for updates. Email alerts are available at https://www.annovisbio.com/email-alerts.

Specialty pharmacies and distributors (future commercial channel)

As Annovis Bio, Inc. remains in late-stage clinical development, the formal channel for drug distribution via specialty pharmacies and distributors is not yet active. This channel is contingent upon successful completion of the Phase 3 trials and subsequent New Drug Application (NDA) submission and approval. The symptomatic readout is targeted for H2 2026, which would precede commercial launch planning.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Customer Segments

You're looking at the core groups Annovis Bio, Inc. (ANVS) targets with buntanetap, which is a critical view before we even touch on how they plan to make money. Honestly, for a late-stage biotech, the customer segments are laser-focused on the clinical and financial gatekeepers.

Patients with early Alzheimer's Disease (AD) and biomarker-confirmed pathology

This segment represents the primary indication for the pivotal Phase 3 trial. The patient pool is substantial, though Annovis Bio, Inc. is specifically targeting the early stage, which is where their biomarker data suggests the greatest impact. The company's Phase 3 AD clinical trial is fully activated across 84 U.S. clinical sites as of late 2025. This focus is on patients whose pathology can be confirmed, likely including those with the ApoE4 carrier status mentioned in prior studies.

Here are some relevant population statistics for context:

• Americans currently living with Alzheimer's Disease: 6.9M
• Projected Americans to be diagnosed with Alzheimer's by 2060: 2X the current number
• Historical success rate for developing new Alzheimer's treatments: 2%

Patients with Parkinson's Disease (PD), especially those with cognitive decline

This segment is important because Annovis Bio, Inc. is demonstrating that PD cognitive decline often overlaps with AD pathology. The data suggests a strong response in PD patients who also have this co-pathology. The company is also preparing for a Type C meeting with the FDA in January 2026 to discuss the development pathway for Parkinson's disease dementia (PDD), a serious complication within this group.

The scope of this patient group and its complication is significant:

PD Patient Metric	Number/Percentage	Source Context
Americans living with Parkinson's Disease	1M	Current prevalence data.
Projected Americans with PD by 2030	1.2M	Near-term projection.
PD Patients developing Dementia (PDD)	Approximately 30%	Target for the PDD program.
PD Patients potentially developing Dementia (Long-term)	Up to 80%	Long-term risk profile.
PD Phase 3 Study Participants with Amyloid Co-pathology	Approximately 25%	Observed in the Phase 3 PD trial.

Neurologists and specialists treating neurodegenerative disorders

These are the prescribers and key opinion leaders (KOLs) who validate the clinical data and ultimately recommend the therapy. Their segment is reached through scientific presentations, such as those at the CTAD 2025 conference, where Annovis Bio, Inc. presented on both its AD and PD programs. The company is focused on convincing this group that buntanetap offers a disease-modifying potential by reducing neuroinflammation and neurodegeneration markers like pTau217, total tau, and brain-derived tau.

Engagement points for this segment include:

• Presentations at CTAD 2025 conference (December 1-4, 2025)
• Discussions on novel therapeutic and biomarker strategies for PD and related disorders
• Data supporting reductions in neuroinflammation and neurodegeneration markers

Institutional investors and biotech-focused venture capital firms

This group provides the necessary capital to fund the late-stage clinical trials and operations. You need to keep them informed on cash runway and R&D spend. As of September 30, 2025, Annovis Bio, Inc. reported cash and cash equivalents of $15.3M, which, along with recent offerings, was stated to fund operations through Q3 2026. Research and development expenses for Q3 2025 were $6.3M. The company had 20.2M shares of common stock outstanding as of that date.

The institutional landscape as of late 2025 shows active management:

Investor Group Metric	Value as of Q3 2025	Key Holders Mentioned
Total Institutional Owners Filing Forms	51	Vanguard Group Inc., Geode Capital Management, Llc
Total Institutional Shares Reported (13F, Q3 2025)	2,022,566	Susquehanna International Group, Llp, Citadel Advisors Llc
Stock Price (as of Nov 21, 2025)	$3.79 / share	BlackRock, Inc. held 80,675 shares as of 9/30/2025

The basic and diluted net loss per common share for the three months ending September 30, 2025, was $0.37. Finance: draft 13-week cash view by Friday.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Cost Structure

You're looking at the core spending that fuels Annovis Bio, Inc.'s late-stage development, which is heavily weighted toward clinical execution and securing the future of buntanetap. For a clinical-stage biotech, the cost structure is almost entirely operational burn, centered on the drug trials.

The most significant cost driver is Research and Development (R&D), which reflects the intensive work of advancing the pivotal Phase 3 Alzheimer's disease trial. For the three months ended September 30, 2025, Annovis Bio, Inc. reported R&D expenses of $6.3 million. This figure is up significantly from $2.7 million in the same period in 2024, showing the ramp-up in trial activity.

General and Administrative (G&A) expenses are the next major component, covering overhead, executive salaries, and corporate functions. In Q3 2025, G&A expenses totaled $1.1 million, a decrease from $1.7 million reported in Q3 2024. This reduction in administrative spend, while R&D surged, suggests a focus on operational efficiency to preserve cash.

Here's a quick look at the key quarterly expense categories for Annovis Bio, Inc. for the third quarter of 2025:

Cost Category	Amount (Three Months Ended Sept 30, 2025)
Research and Development (R&D) Expenses	$6.3 million
General and Administrative (G&A) Expenses	$1.1 million
Total Reported Operating Expenses (R&D + G&A)	$7.4 million

Clinical trial expenses are embedded within the R&D figure, but the scale of the operation gives you a sense of the magnitude of these costs. You should know that the pivotal Phase 3 Alzheimer's disease trial has reached full activation across 84 U.S. sites as of late 2025. These sites drive costs related to site activation, patient recruitment, drug administration, and ongoing patient monitoring, all critical for generating reliable data.

Protecting the intellectual property (IP) is a non-negotiable, albeit less visible, cost. Annovis Bio, Inc. has been actively managing this, having completed the transfer of all patent families for the new crystalline form of buntanetap. This action secures global IP protection through the year 2046. These costs include:

• Patent maintenance fees for international filings.
• Legal fees associated with IP prosecution and defense.
• Costs related to the transfer and formalization of the new crystalline form patents.

The company's cash position as of September 30, 2025, stood at $15.3 million, which, following October financing activities, management indicated was sufficient to fund operations into the third quarter of 2026. The burn rate implied by the Q3 operating expenses, coupled with other non-cash items, dictates the runway you need to track closely.

Finance: draft 13-week cash view by Friday.

Annovis Bio, Inc. (ANVS) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Annovis Bio, Inc. (ANVS) as of late 2025. Since the company is deep in clinical development, the revenue profile is entirely focused on non-product sources right now, with the big money sitting in the future, contingent on regulatory success.

Current revenue is $0.00 from product sales, which is absolutely typical for a clinical-stage firm like Annovis Bio, Inc. They are not selling any commercialized drugs yet; all resources are directed toward advancing buntanetap through its pivotal trials.

The primary current cash inflow comes from financing activities, essentially selling ownership stakes to fund the expensive clinical work. You can see the recent capital raises below:

Financing Event	Date Announced/Closed	Gross Proceeds Amount	Per Share Price
Registered Direct Offering	October 2025 (Closed Oct 15, 2025)	$6.0 million	$1.50 per share
Registered Direct Offering	October 2025 (Closed Oct 28, 2025 est.)	$3.4 million	$2.05 per share
Total October 2025 Offerings	October 2025	$9.4 million	N/A
Public Offering	February 2025	$21 million	N/A

The combined gross proceeds from the October 2025 offerings totaled $9.4 million. Remember, these are gross figures; placement agent fees and expenses will reduce the net cash received. As of September 30, 2025, the cash balance was $15.3 million, which incorporated these October funds. Honestly, this cash runway is what keeps the lights on until the next data readout.

Future revenue streams are entirely potential, tied to the success of buntanetap in the clinic. These are the non-dilutive possibilities that analysts watch closely:

• Future potential milestone payments from any in-licensing or collaboration agreements that Annovis Bio, Inc. might secure.
• Royalties or product sales revenue following potential regulatory approval (NDA submission) for buntanetap in Alzheimer's disease (AD) or Parkinson's disease (PD).
• Potential payments related to the new crystalline form of buntanetap patents secured through 2046.

The near-term focus is on the pivotal Phase 3 AD trial, which is aiming for symptomatic data in the second half of 2026, the final step before an NDA submission. That readout is the trigger for any serious discussions about milestone payments or future commercialization revenue sharing.

To be fair, the specific dollar amounts for future milestone payments or royalty percentages are not public information at this stage; they are locked away in potential future agreements. What this estimate hides is the risk that these future streams never materialize if the drug fails to meet its primary endpoints.

Finance: draft 13-week cash view by Friday.