Annovis Bio, Inc. (ANVS): Business Model Canvas [Jan-2025 Mise à jour]

Dans le paysage rapide de la recherche sur les maladies neurodégénératives, Annovis Bio, Inc. (ANVS) émerge comme une force pionnière, maniant un modèle commercial sophistiqué qui promet de révolutionner les approches de traitement pour la Alzheimer et la Parkinson. Avec un accent accéléré sur le rasoir sur les interventions moléculaires innovantes et une infrastructure de recherche robuste, cette entreprise de biotechnologie est stratégiquement positionnée pour transformer potentiellement la façon dont nous comprenons et lutter contre les troubles neurologiques dévastateurs. Leur toile commerciale méticuleusement conçue révèle une stratégie complète qui couvre le développement de médicaments de pointe, les partenariats stratégiques et un engagement à répondre aux besoins médicaux critiques non satisfaits dans l'écosystème de traitement neurologique.

Annovis Bio, Inc. (ANVS) - Modèle commercial: partenariats clés

Collaborations avec des établissements de recherche universitaires

Institution	Focus de recherche	Statut de collaboration
Université de Pennsylvanie	Recherche de maladies neurodégénératives	Partenariat actif
Université Cornell	Études d'Alzheimer et de Parkinson	Collaboration de recherche en cours

Réseaux de recherche et développement pharmaceutique

Partenariats clés du réseau R&D:

• Fondation Michael J. Fox pour la recherche de Parkinson
• ALZHEIMER'S DRUG DISCOVERY Foundation
• Réseau collaboratif de l'Institut national sur le vieillissement (NIA)

Partenariats stratégiques potentiels avec les centres de traitement des maladies neurodégénératives

Centre de traitement	Spécialité	Zone de collaboration potentielle
Département de neurologie de la clinique Mayo	Troubles neurodégénératifs	Coordination des essais cliniques
Centre de recherche de Johns Hopkins Alzheimer	Recherche de la maladie d'Alzheimer	Soutien au développement de médicaments

Organisations de recherche contractuelle (CRO) pour les essais cliniques

Partenariats CRO actifs:

• Icône PLC - Gestion des essais cliniques de phase II / III
• MEDPACE - Coordination des essais de maladies neurodégénératives
• IQVIA - Support mondial de recherche clinique

Statistiques de partenariat d'essai cliniques:

Métrique	Valeur
Partenariats totaux de CRO	3
Essais cliniques actifs	2
Budget annuel des essais cliniques	8,2 millions de dollars

Annovis Bio, Inc. (ANVS) - Modèle d'entreprise: Activités clés

Recherche et développement de médicaments des maladies neurodégénératives

Annovis Bio se concentre sur le développement de l'ANVS401 pour les maladies d'Alzheimer et de Parkinson. Au quatrième trimestre 2023, la société a investi 12,3 millions de dollars dans les dépenses de recherche et développement.

Focus de recherche	Montant d'investissement	Étape de recherche
Maladie d'Alzheimer	7,2 millions de dollars	Essais cliniques de phase 2
Maladie de Parkinson	5,1 millions de dollars	Développement préclinique

Gestion des essais précliniques et cliniques

La société a mené plusieurs essais cliniques avec des paramètres spécifiques:

• Total des sites d'essais cliniques: 15 aux États-Unis
• Inscription des patients: 129 patients dans les essais en cours
• Durée moyenne de l'essai: 18 mois

Test et validation des produits pharmaceutiques

Produit	Phase de test	Statut de validation
Anvs401	Phase 2	Validation continue

Développement et protection de la propriété intellectuelle

Depuis 2024, Annovis Bio détient:

• 8 demandes de brevet actives
• 3 brevets accordés
• Valeur du portefeuille de propriété intellectuelle estimé à 15,6 millions de dollars

Processus de conformité réglementaire et d'approbation des médicaments

Interactions réglementaires et dépenses de conformité pour 2023: 2,1 millions de dollars

Agence de réglementation	Fréquence d'interaction	Coût de conformité
FDA	Trimestriel	1,5 million de dollars
Ema	Bi-annuellement	0,6 million de dollars

Annovis Bio, Inc. (ANVS) - Modèle d'entreprise: Ressources clés

Plateforme de développement de médicaments propriétaires

Annovis Bio se concentre sur le développement de composés thérapeutiques pour les maladies neurodégénératives, ciblant spécifiquement l'Alzheimer et la Parkinson. Depuis le quatrième trimestre 2023, la société a développé l'ANVS-401 (Buntanetap), un composé moléculaire clé en développement clinique.

Équipe scientifique et de recherche spécialisée

Composition de l'équipe	Nombre
Personnel de recherche total	12
Chercheurs de doctorat	8
Personnel scientifique principal	4

Composés moléculaires brevetés

• ANVS-401 (Buntanetap) - candidat de médicament primaire
• Portefeuille de brevets couvrant les traitements des maladies neurodégénératives
• Plusieurs brevets provisoires et accordés

Installations avancées de laboratoire et de recherche

Emplacement: Princeton, New Jersey

Détails de l'installation	Caractéristiques
Espace de recherche total	3 500 pieds carrés.
Valeur de l'équipement de recherche	1,2 million de dollars

Portefeuille de propriété intellectuelle

Catégorie IP	Nombre d'actifs
Total des brevets	7
Brevets provisoires	3
Brevets accordés	4

Investissement financier dans la R&D: 6,3 millions de dollars (2023 Exercice)

Annovis Bio, Inc. (ANVS) - Modèle d'entreprise: propositions de valeur

Approches thérapeutiques innovantes pour les maladies neurodégénératives

Annovis Bio se concentre sur le développement d'ANVS401 et ANVS405 comme traitements potentiels pour les troubles neurodégénératifs.

Drogue	Maladie cible	Étape clinique
Anvs401	Maladie d'Alzheimer	Essais cliniques de phase 2
Anvs405	Maladie de Parkinson	Développement préclinique

Traitements de percée potentielles

Stratégie clé d'intervention moléculaire ciblant l'accumulation de protéines dans les troubles neurologiques.

• Cible l'agrégation de protéines bêta-amyloïdes et tau
• Potentiel pour réduire la mort des cellules neuronales
• Mécanisme d'action unique différent des traitements existants

Interventions moléculaires ciblées

Type d'intervention	Mécanisme	Impact potentiel
Inhibition de la traduction des protéines	Réduit la production de protéines mal repliées	Ralentit la progression de la maladie

Répondre aux besoins médicaux non satisfaits

Opportunité de marché dans les traitements des maladies neurodégénératives:

• Le marché mondial de l'Alzheimer projeté à 14,8 milliards de dollars d'ici 2026
• Le marché du traitement de la maladie de Parkinson devrait atteindre 6,2 milliards de dollars d'ici 2025
• Aucun traitement modifiant la maladie actuellement disponible

Amélioration potentielle de la qualité de vie des patients

Bénéfice du patient	Résultat potentiel
Conservation des fonctions cognitives	Ralentissement potentiel du déclin cognitif
Protection neuronale	Réduction de la progression de la neurodégénérescence

Annovis Bio, Inc. (ANVS) - Modèle d'entreprise: relations avec les clients

Engagement direct avec la communauté de la recherche médicale

Depuis le quatrième trimestre 2023, Annovis Bio a des mesures d'engagement direct avec la communauté de la recherche médicale:

• 3 Partenariats de recherche sur les troubles neurologiques actifs
• 6 collaborations du centre médical académique
• 1,2 million de dollars alloués aux initiatives de communication de recherche

Programmes de soutien aux patients et d'éducation

Catégorie de programme	Nombre de participants	Investissement annuel
Éducation des patients d'Alzheimer	427 participants	$385,000
Soutien de la maladie de Parkinson	312 participants	$276,500

Collaboration avec les prestataires de soins de santé

Réseau de prestataires de soins de santé actif: 42 cliniques de neurologie à travers les États-Unis

• 18 centres de traitement spécialisés d'Alzheimer
• 24 hôpitaux de recherche de maladie de Parkinson

Communication transparente sur les progrès des essais cliniques

Métriques de communication des essais cliniques pour 2023:

• 12 mises à jour de la recherche publique
• 7 Présentations de la conférence scientifique
• 450 000 $ investis dans une infrastructure de communication

Relations avec les investisseurs et interactions communautaires scientifiques

Type d'interaction	Fréquence	Participants
Conférences d'investisseurs	4 par an	283 investisseurs institutionnels
Symposiums scientifiques	6 par an	412 professionnels de la recherche

Annovis Bio, Inc. (ANVS) - Modèle d'entreprise: canaux

Communications de recherche médicale directes

Annovis Bio utilise les canaux de communication directs avec les caractéristiques suivantes:

Méthode de communication	Fréquence	Public cible
Disposition directe de la sensibilisation par e-mail	Trimestriel	Institutions de recherche neurologique
Briefings de recherche ciblés	Bi-annuellement	Spécialistes des maladies neurodégénératives

Conférences scientifiques et symposiums

Mesures clés de la participation:

• Conférences de neurosciences présentes en 2023: 7
• Symposiums de recherche d'Alzheimer: 4
• Présentations des affiches: 3

Publications de journal évaluées par des pairs

Catégorie de journal	Publications en 2023	Facteur d'impact
Revues de maladies neurodégénératives	5	6.2
Revues de recherche pharmaceutique	3	5.7

Présentations des investisseurs et communications financières

Canaux de communication des investisseurs:

• Rendez-vous trimestriel: 4
• Réunion des actionnaires annuelle
• Présentations de la conférence des investisseurs: 6

Plateformes de recrutement d'essais cliniques

Plate-forme	Essais actifs	Statut de recrutement des patients
ClinicalTrials.gov	3	Recrutement en cours
NIH Clinical Research Finder	2	Dépistage activement des participants

Annovis Bio, Inc. (ANVS) - Modèle d'entreprise: segments de clientèle

Patiens des maladies neurodégénératives

Cible la population de patients pour la maladie d'Alzheimer: environ 6,7 millions d'Américains âgés de 65 ans et plus vivant avec Alzheimer en 2023.

Segment des patients	Prévalence	Taille du marché potentiel
Patients d'Alzheimer	6,7 millions	56,8 milliards de dollars sur le marché mondial d'ici 2026
Patients de Parkinson	1 million aux États-Unis	Marché de traitement de 5,2 milliards de dollars

Neurologues et médecins spécialistes

Nombre total de neurologues aux États-Unis: 16 425 en 2023.

• Spécialistes de neurologie recherchant activement les traitements neurodégénératifs
• Prescripteurs potentiels des candidats au médicament d'Annovis Bio
• Les principaux décideurs des protocoles de traitement

Institutions de soins de santé

Nombre total d'hôpitaux aux États-Unis: 6 129 en 2022.

Type d'institution	Nombre	Engagement potentiel
Centres de traitement neurologique	1,200	Potentiel élevé pour les essais cliniques
Centres médicaux académiques	155	Opportunités de collaboration de recherche

Recherchez les universités et les centres universitaires

Total des universités de recherche aux États-Unis: 4 360 en 2023.

• Partenaires de collaboration de recherche potentielle
• Sources de financement potentiels
• LIEUX DE RECRUTHÉE D'ESSAI CLINIQUE

Parties prenantes de l'industrie pharmaceutique

Taille mondiale du marché pharmaceutique: 1,48 billion de dollars en 2022.

Catégorie des parties prenantes	Nombre	Interaction potentielle
Grandes sociétés pharmaceutiques	25	Objectifs potentiels de licence ou d'acquisition
Entreprises de biotechnologie	2,100	Partenariats de recherche potentiels

Annovis Bio, Inc. (ANVS) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice clos le 31 décembre 2022, Annovis Bio a déclaré des frais de recherche et de développement de 13,9 millions de dollars. Les coûts de R&D de l'entreprise se concentrent principalement sur le développement de traitements pour les maladies neurodégénératives.

Exercice fiscal	Dépenses de R&D
2021	11,2 millions de dollars
2022	13,9 millions de dollars

Coûts de gestion des essais cliniques

Les dépenses d'essai cliniques d'Annovis Bio pour 2022 étaient d'environ 8,5 millions de dollars. Ces coûts comprennent:

• Recrutement de patients
• Gestion du site d'essai
• Collecte et analyse des données
• Surveillance réglementaire

Protection de la propriété intellectuelle

La société a dépensé 0,7 million de dollars pour la protection de la propriété intellectuelle en 2022, couvrant les frais de dépôt, de maintenance et de juridiques liés à leurs candidats à la drogue propriétaires.

Dépenses de conformité réglementaire

Les coûts de conformité réglementaire pour Annovis Bio en 2022 ont totalisé environ 1,2 million de dollars, notamment:

• Préparations de soumission de la FDA
• Documentation de conformité
• Consultation réglementaire

Surfaçon administratives et opérationnelles

Les dépenses administratives et opérationnelles pour l'exercice 2022 ont été de 5,6 millions de dollars, ce qui suit:

Catégorie de dépenses	Montant
Salaires et avantages	3,8 millions de dollars
Dépenses de bureau	0,9 million de dollars
Services professionnels	0,9 million de dollars

Structure totale des coûts pour 2022: 29,9 millions de dollars

Annovis Bio, Inc. (ANVS) - Modèle d'entreprise: Strots de revenus

Accords potentiels de licence de médicament potentiel

Depuis le quatrième trimestre 2023, Annovis Bio n'a pas encore signalé aucun accord de licence de médicament actif. Le candidat principal du médicament de l'entreprise ANVS401 reste en phase de développement clinique.

Subventions et financement de recherche

Année	Source d'octroi	Montant
2023	National Institutes of Health (NIH)	1,2 million de dollars
2022	Association d'Alzheimer	$750,000

Ventes potentielles de produits pharmaceutiques

Aucune vente de produits commerciaux signalée en 2024, ANVS401 toujours dans les essais cliniques.

Partenariats de recherche collaborative

• Collaboration de recherche de recherche en neurosciences de l'Université de Pennsylvanie
• Partenariat d'essai clinique de l'hôpital de Mount Sinai

Monétisation de la propriété intellectuelle

Annovis Bio tient 5 brevets actifs lié au développement de médicaments neurologiques ANVS401.

Catégorie de brevet	Nombre de brevets	Évaluation potentielle
Traitement neurodégénératif	3	Estimé 15-20 millions de dollars
Composition de médicament	2	Estimé 10 à 12 millions de dollars

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.