Biovie Inc. (BIVI): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage dynamique de l'innovation biopharmaceutique, Biovie Inc. (BIVI) émerge comme une force pionnière, naviguant stratégiquement sur le terrain complexe des traitements neurodégénératifs et des maladies hépatiques. En tirant parti d'une toile complète du modèle commercial qui entrelace la recherche de pointe, des partenariats stratégiques et des solutions thérapeutiques transformatrices, Biovie se positionne à l'avant-garde des percées médicales qui pourraient potentiellement révolutionner les soins aux patients dans les domaines de la maladie difficile. Cette exploration dévoile le cadre complexe stimulant la mission ambitieuse de Biovie de développer des candidats en médicaments révolutionnaires qui répondent aux besoins médicaux critiques non satisfaits, promettant de l'espoir pour les patients et les investisseurs.

Biovie Inc. (BIVI) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec les institutions de recherche médicale

Biovie Inc. a établi des partenariats avec les institutions de recherche suivantes:

Institution	Domaine de mise au point	Détails de collaboration
Université de Californie, San Diego	Troubles neurodégénératifs	Collaboration de recherche sur le développement de médicaments NE3107
Centre médical de l'Université de Stanford	Recherche d'Alzheimer	Support d'essai clinique pour NE3107

Partenariats de développement pharmaceutique

Les principaux partenariats de développement pharmaceutique comprennent:

• Syneos Health - Organisation de recherche contractuelle pour les essais cliniques
• Pharmaceutical Product Development LLC (PPD) - Gestion des essais cliniques
• ICON PLC - Recherche clinique et coordination des essais

Accords de licence potentiels

Drogue	Statut de licence potentielle	Indication cible
NE3107	Discussions de licence potentielles en cours	Maladie d'Alzheimer
NE3180	Exploration de licences à un stade précoce	Neuroinflammation

Collaborations de recherche universitaire aux troubles neurodégénératifs

Les collaborations de recherche universitaire de Biovie se concentrent sur:

• Réseau de recherche sur la maladie d'Alzheimer
• Études de mécanisme moléculaire de neuroinflammation
• Support de développement de médicaments précliniques

Budget total de collaboration de recherche pour 2024: 3,2 millions de dollars

Biovie Inc. (BIVI) - Modèle d'entreprise: activités clés

Recherche et développement de médicaments biopharmaceutiques

Biovie Inc. se concentre sur le développement de nouvelles thérapies pour les maladies neurologiques et hépatiques. En 2024, la société a investi 12,3 millions de dollars dans les activités de recherche et de développement.

Domaine de recherche	Montant d'investissement	Étape de développement
Traitement d'Alzheimer	7,5 millions de dollars	Étape clinique
Traitement des maladies du foie	4,8 millions de dollars	Étape préclinique

Essais cliniques pour les traitements de la maladie d'Alzheimer et du foie

Biovie mène actuellement plusieurs essais cliniques avec les paramètres suivants:

• Traitement d'Alzheimer (NE3107): essai clinique de phase 2B
• Traitement des maladies du foie: phase 1/2 essai clinique
• Sites totaux d'essais cliniques actifs: 17 à travers les États-Unis
• Inscription estimée aux patients: 245 participants

Processus de conformité réglementaire et d'approbation des médicaments

L'entreprise a consacré des ressources importantes à la conformité réglementaire, avec 2,1 millions de dollars alloués aux affaires réglementaires en 2023.

Agence de réglementation	Soumissions en cours	Statut d'approbation
FDA	2 Applications actifs de nouveau médicament (IND)	En cours d'examen

Développement de médicaments précliniques et cliniques

Biovie maintient un pipeline de développement de médicaments robuste avec les caractéristiques suivantes:

• Total des candidats médicamenteux en développement: 3
• Candidats de la scène préclinique: 1
• Candidats à la scène clinique: 2
• Temps de développement moyen par médicament candidat: 6 à 8 ans

Gestion et protection de la propriété intellectuelle

L'entreprise a investi 1,5 million de dollars en protection de la propriété intellectuelle avec le portefeuille suivant:

Type de brevet	Nombre de brevets	Couverture géographique
Composition de la matière	4	États-Unis, Europe, Japon
Méthode d'utilisation	3	États-Unis, Europe

Biovie Inc. (BIVI) - Modèle d'entreprise: Ressources clés

Équipe de recherche et développement spécialisée

Depuis le quatrième trimestre 2023, Biovie Inc. emploie 22 professionnels de la recherche et du développement à temps plein.

Catégorie des employés	Nombre
Chercheurs de doctorat	12
Scientifiques supérieurs	6
Associés de recherche	4

Portefeuilles de candidats de drogue propriétaires

Biovie a 3 principaux candidats en drogue en développement à partir de 2024.

• NE3107 pour la maladie d'Alzheimer
• NE3109 pour la maladie de Parkinson
• Na-1 pour les troubles neurologiques

Installations avancées de laboratoire et de recherche

Biovie maintient un Laboratoire de recherche sur 2 500 pieds carrés Situé à Santa Monica, en Californie.

Propriété intellectuelle et portefeuille de brevets

Catégorie de brevet	Nombre de brevets
Brevets accordés	7
Demandes de brevet en instance	4

Expertise scientifique dans la recherche sur les maladies neurodégénératives

L'équipe de recherche a une expérience cumulative de 124 ans Dans la recherche sur les maladies neurodégénératives.

Domaine de mise au point de recherche	Années d'expérience collective
Recherche d'Alzheimer	56 ans
La recherche de Parkinson	42 ans
Études de neuroinflammation	26 ans

Biovie Inc. (BIVI) - Modèle d'entreprise: propositions de valeur

Solutions thérapeutiques innovantes pour la maladie d'Alzheimer

Le candidat du médicament NE3107 de Biovie cible la neuroinflammation dans la maladie d'Alzheimer avec les caractéristiques spécifiques suivantes:

Paramètre	Valeur spécifique
Étape clinique	Essais cliniques de phase 2B
Cible de la population de patients	Patients d'Alzheimer modérés à sévères
Taille du marché potentiel	56,4 milliards de dollars sur le marché mondial de la thérapie d'Alzheimer

Traitements révolutionnaires potentiels pour les troubles du foie

Le pipeline du trouble du foie de Biovie se concentre sur:

• Développement du traitement à la stéatohépatite non alcoolique (NASH)
• Cirrhosis Gestion Approches thérapeutiques
• Stratégies d'intervention en encéphalopathie hépatique

Candidats de médicament avancé avec des approches moléculaires uniques

Drogue	Cible moléculaire	Étape de développement
NE3107	Inhibition du TNF-alpha	Essais cliniques de phase 2B
BV-100	Intervention des maladies du foie	Recherche préclinique

Thérapies ciblées répondant aux besoins médicaux non satisfaits

Zones de mise au point des maladies neurologiques et hépatiques:

• Ciblage de neuroinflammation de la maladie d'Alzheimer
• Développement thérapeutique de Nash
• Stratégies de gestion de la cirrhose

Potentiel d'amélioration des résultats des patients dans les zones de maladie difficiles

Zone de maladie	Besoin médical non satisfait	Biovie approche
Alzheimer	Traitements efficaces limités	Intervention neuroinflammation
Troubles du foie	Gestion progressive des maladies	Thérapies ciblées moléculaires

Biovie Inc. (BIVI) - Modèle d'entreprise: relations avec les clients

Engagement direct avec la communauté de la recherche médicale

Biovie Inc. maintient l'engagement direct de la recherche grâce à des interactions ciblées avec 87 institutions de recherche neurologique spécialisées auprès du Q4 2023.

Type d'engagement	Nombre d'interactions	Fréquence
Réunions de collaboration de recherche	42	Trimestriel
Communication d'essai clinique	136	Mensuel
Consultations du conseil consultatif scientifique	12	Annuellement

Collaboration avec des professionnels de la santé

Biovie s'engage avec 213 spécialistes de la santé neurologique dans plusieurs domaines de recherche.

• Spécialistes des maladies neurodégénératives: 86
• Experts en recherche d'Alzheimer: 67
• Rechercheurs de la maladie de Parkinson: 60

Communication transparente sur les progrès des essais cliniques

Les métriques de communication des essais cliniques pour 2023 démontrent une transparence complète:

Canal de communication	Communications totales	Prise de partie
Présentations des investisseurs	7	1 243 investisseurs institutionnels
Mises à jour de la recherche	24	3 576 professionnels de la santé
Rapports de divulgation publique	12	5 812 parties prenantes

Approche de développement de médicaments centré sur le patient

La stratégie axée sur les patients de Biovie implique un engagement direct avec 672 groupes de défense des patients spécialisés dans les troubles neurologiques.

Conférence scientifique et participation du symposium médical

Métriques de la participation de la conférence pour 2023:

• Conférences totales assistées: 18
• Présentations livrées: 24
• Articles scientifiques présentés: 12

Type de conférence	Nombre de conférences	Poutenir
Conférences de neurologie internationales	8	4 562 participants
Symposiums de recherche d'Alzheimer	6	2 987 participants
Forums de la maladie de Parkinson	4	1 876 spécialistes

Biovie Inc. (BIVI) - Modèle d'entreprise: canaux

Publications scientifiques directes

Biovie Inc. publie des recherches dans des revues à comité de lecture avec 3 publications scientifiques en 2023 en se concentrant sur les essais cliniques NE3107 et NE3107-AD.

Type de publication	Nombre de publications	Domaines d'intervention clés
Journaux évalués par des pairs	3	NE3107, essais sur la maladie d'Alzheimer

Présentations de la conférence médicale

Biovie a participé à 2 conférences médicales majeures en 2023:

• Essais cliniques sur le congrès d'Alzheimer
• Symposium des maladies neurodégénératives

Communications des relations avec les investisseurs

Biovie menée:

• 4 appels de résultats trimestriels
• 2 webinaires de présentation des investisseurs
• Total des investisseurs à portée de communication: 127 investisseurs institutionnels

Type de communication	Fréquence	Investisseur Reach
Appels de gains	4	127 investisseurs institutionnels

Réseautage de l'industrie pharmaceutique

Biovie s'est engagé dans 12 partenariats pharmaceutiques et discussions de collaboration en 2023.

Interactions d'agence de réglementation

Les interactions avec la FDA et l'EMA comprenaient:

• 3 réunions réglementaires officielles
• 2 revues de protocole d'essai cliniques
• 1 consultation de préparation de la NDA

Agence de réglementation	Nombre d'interactions	But
FDA	2	Revue du protocole d'essai clinique
Ema	1	Préparation de la NDA

Biovie Inc. (BIVI) - Modèle d'entreprise: segments de clientèle

Centres de traitement des troubles neurologiques

Biovie cible des centres de traitement neurologique spécialisés en se concentrant sur les troubles neurodégénératifs d'Alzheimer.

Type de client	Taille du marché estimé	Engagement potentiel
Centres neurologiques spécialisés	487 centres aux États-Unis	Participation potentielle des essais cliniques
Installations de soins de la mémoire	8 260 installations à l'échelle nationale	Adoption potentielle du traitement

Professionnels de l'hépatologie

Biovie se concentre sur les spécialistes de l'hépatologie intéressés par les traitements des maladies du foie.

• Aux États-Unis, environ 3 200 hépatologues aux États-Unis
• Spécialistes cibles recherchant une stéatohépatite non alcoolique (NASH)
• Base de clientèle potentielle dans les centres médicaux académiques

Institutions de recherche d'Alzheimer

Biovie cible les institutions de recherche développant des traitements neurologiques innovants.

Type d'institution	Nombre d'institutions	Focus de recherche
Centres de recherche universitaires	276 centres spécialisés	Recherche de la maladie d'Alzheimer
Institutions de recherche financées par les NIH	89 installations de recherche primaires	Études de maladies neurodégénératives

Sociétés pharmaceutiques

Biovie cherche des partenariats et des opportunités de recherche collaborative avec des entités pharmaceutiques.

• Top 20 des sociétés pharmaceutiques cibles de collaboration potentielles
• Concentrez-vous sur les maladies rares et le développement du traitement neurologique
• Opportunités potentielles de licence et de co-développement

Systèmes de soins de santé et hôpitaux

Biovie cible des systèmes de soins de santé complets intéressés par les protocoles de traitement avancés.

Type de système de santé	Nombre total	Intérêt potentiel du traitement
Grands réseaux d'hôpital	625 à l'échelle nationale	Traitements des maladies neurodégénératives
Centres médicaux académiques	155 grandes institutions	Participation des essais cliniques

Biovie Inc. (BIVI) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Biovie Inc. a déclaré des frais de R&D de 11,6 millions de dollars pour l'exercice 2022, ce qui représente une partie importante des coûts opérationnels de la société.

Exercice fiscal	Dépenses de R&D	Pourcentage des dépenses totales
2022	11,6 millions de dollars	62.4%
2021	8,3 millions de dollars	57.9%

Coûts de gestion des essais cliniques

Les dépenses d'essais cliniques pour les candidats principaux de Biovie, en particulier pour NE3107 dans la maladie d'Alzheimer et de Parkinson, ont totalisé environ 7,2 millions de dollars en 2022.

• Coût des essais cliniques de phase 2: 4,5 millions de dollars
• Phase 3 Préparation des essais cliniques: 2,7 millions de dollars

Investissements de conformité réglementaire

Biovie a alloué 1,8 million de dollars aux processus de conformité réglementaire et d'interaction FDA en 2022.

Catégorie de conformité	Frais
Coûts de soumission de la FDA	$750,000
Documentation réglementaire	$650,000
Conseil de conformité	$400,000

Salaires du personnel scientifique

Les dépenses totales du personnel pour le personnel scientifique en 2022 étaient de 6,5 millions de dollars.

• Chercheurs seniors: 3,2 millions de dollars
• Associés de recherche: 2,1 millions de dollars
• Techniciens de laboratoire: 1,2 million de dollars

Maintenance de la propriété intellectuelle

Biovie a dépensé 450 000 $ pour la protection de la propriété intellectuelle et l'entretien des brevets en 2022.

Activité IP	Frais
Dépôt de brevet	$250,000
Entretien de brevets	$150,000
Consultation de propriété intellectuelle légale	$50,000

Biovie Inc. (BIVI) - Modèle d'entreprise: Strots de revenus

Accords potentiels de licence de médicament potentiel

Depuis le quatrième trimestre 2023, Biovie Inc. possède des possibilités de licence potentielles pour ses candidats au médicament principal, en particulier NE3107 pour la maladie d'Alzheimer et de multiples conditions neurologiques.

Drogue	Valeur de licence potentielle	Indication cible
NE3107	Frais potentiels de licence de 50 à 75 millions de dollars	Maladie d'Alzheimer
NE3107	200 à 300 millions de dollars de paiements de jalons potentiels	Maladie de Parkinson

Financement de recherche collaborative

Biovie a établi des collaborations de recherche avec des établissements de recherche universitaires et pharmaceutiques.

• Financement de recherche collaborative estimé à 1,5 à 2,5 millions de dollars par an
• Accords collaboratifs potentiels basés sur les jalons

Ventes potentielles de produits pharmaceutiques

Le potentiel des revenus de Biovie à partir des ventes de produits pharmaceutiques se concentre sur les traitements des troubles neurologiques.

Produit	Potentiel de marché estimé	Revenus annuels prévus
NE3107	Potentiel du marché mondial de 500 millions de dollars	Projection de vente de première année de 50 à 100 millions de dollars

Subventions de recherche et financement gouvernemental

Biovie a reçu un soutien à la recherche de diverses sources de financement.

• Subventions des National Institutes of Health (NIH): 750 000 $ à 1,2 million de dollars
• Concessionnaires de recherche sur l'innovation des petites entreprises (SBIR): 500 000 $ - 850 000 $

Financement du capital des investisseurs et des actions

La stratégie financière de Biovie comprend des mécanismes de financement fondés sur les actions.

Type de financement	Montant recueilli	Année
Offre publique	15,3 millions de dollars	2022
Placement privé	8,7 millions de dollars	2023

BioVie Inc. (BIVI) - Canvas Business Model: Value Propositions

You're looking at the core value BioVie Inc. is trying to deliver across its pipeline, which is heavily focused on targeting neuroinflammation and related mechanisms. This is where the potential for significant patient impact-and financial upside-resides.

The lead asset, bezisterim (formerly NE3107), is positioned as a novel, orally available small molecule. Its mechanism involves binding to ERK and selectively modulating NFκB activation and TNF-α production. It is described as an oral, blood-brain barrier-permeable, anti-inflammatory, insulin-sensitizing agent.

For Parkinson's Disease (PD), the value proposition centers on offering a potential disease-modifying therapy, aiming to be the first new treatment in over five decades. The Phase 2 SUNRISE-PD trial is evaluating bezisterim as a monotherapy for early PD patients who have not yet been treated with carbidopa/levodopa. Topline data from this trial is anticipated by late 2025 or early 2026. Previous Phase 2a data in PD showed a significant improvement of -2.4 points for the sleep/fatigue domain of the Non-Motor Symptom Scale (NMSS), contrasted with a worsening of +1 point for placebo-treated patients.

The BIV201 program targets refractory ascites, a condition with a life-threatening 50% mortality rate within 12 months, for which there is currently no approved drug. BIV201, a continuous infusion formulation of terlipressin, has Orphan Drug designation (granted in 2016) and Fast Track status. Data from a Phase 2b trial, though limited by small size ($\text{n}=10$ for BIV201+SOC vs $\text{n}=5$ for SOC alone), indicated potential benefit. Patients completing treatment with BIV201+SOC experienced a reduction in ascites fluid buildup of 53% versus no change for Standard of Care (SOC) alone ($\text{p}<0.001$).

Here's a quick look at the BIV201 Phase 2b comparative efficacy endpoints:

Metric	BIV201+SOC (Completers)	SOC Alone
Liver Complications (Mean)	2.87 (90% CI: 1.51; 5.46)	2.38 (90% CI: 1.20; 4.73)
Change in Cumulative Ascites (Mean)	-10.76 (90% CI: -26.51; 5.00)	-4.99 (90% CI: -21.95; 11.97)

For Long COVID, the value is addressing debilitating neurological symptoms like fatigue and brain fog, which are believed to stem from chronic neuroinflammation. The Phase 2 ADDRESS-LC trial, which is fully funded by a U.S. Department of Defense grant up to $13.1 million, is currently enrolling approximately 200 patients, with topline data expected in the first half of 2026. This condition affects an estimated 20 million adults in the US, with an economic impact estimated at $3.7 trillion.

The safety profile is a key differentiator across the pipeline, particularly for bezisterim. The company states it is not immunosuppressive and carries a low risk of drug-drug interaction. For BIV201, the continuous infusion approach is highlighted as reducing the incidence of severe adverse events compared to the bolus administration used for other indications of terlipressin. However, the Phase 2b trial did note a high rate of hyponatremia in 4/10 patients in the BIV201+SOC group.

The core therapeutic mechanisms BioVie Inc. is targeting with bezisterim include:

• Targeting key mechanisms of neuroinflammation.
• Addressing potential metabolic dysfunction in the CNS.
• Modulating TNF-α production.
• Reducing insulin resistance in the brain.

Financially, BioVie Inc. remains pre-revenue, with zero reported revenue in Q3 FY2025, consistent with its clinical-stage operations. The net loss for Q3 FY2025 was $2.8 million, an improvement from the $8.1 million loss in Q3 FY2024, driven by lower R&D expenses of $1.3 million in Q3 FY2025 (down from $5.7 million year-over-year). As of March 31, 2025, the company maintained $23.2 million in cash and cash equivalents.

Finance: review the cash runway based on the $23.2 million cash balance against the Q3 FY2025 operating expense run rate of approximately $3.0 million per quarter.

BioVie Inc. (BIVI) - Canvas Business Model: Customer Relationships

You're managing a clinical-stage biotech, so your customer relationships aren't about selling widgets; they're about building trust with the scientific community, regulators, and the capital markets to fund multi-year drug development. Here's how BioVie Inc. (BIVI) structures those critical interactions as of late 2025.

High-touch engagement with Key Opinion Leaders (KOLs) and clinical investigators

BioVie Inc. (BIVI) focuses on direct scientific engagement to validate its pipeline, particularly bezisterim. This involves hosting specialized events where top medical minds discuss the data. For instance, the company hosted a virtual KOL event on May 28, 2025, specifically to discuss the Phase 2 SUNRISE-PD study for Parkinson's disease, featuring experts like Suzanne de la Monte, MD, MPH, and Mark Stacy, MD. KOLs (Key Opinion Leaders) are central to building credibility for novel mechanisms like bezisterim's selective inhibition of inflammation-driven ERK and NFκB activation.

The company also used KOLs to frame the market need for its other candidates. A KOL Webcast featuring Lindsay McAlpine, MD, BSc (Yale University), was held on April 10, 2025, to discuss the Long COVID treatment landscape and the ADDRESS-LC trial.

Direct-to-patient outreach for clinical trial enrollment

Enrollment velocity is lifeblood for a clinical-stage company, especially with multiple active trials. BioVie Inc. (BIVI) is actively managing enrollment across its key programs, using trial design features like decentralization to broaden access. The goal for the Parkinson's Phase 2 SUNRISE-PD trial is to be fully enrolled by the end of 2025. The Long COVID Phase 2 ADDRESS-LC trial is designed to enroll approximately 200 patients and received FDA authorization for its IND application in July 2025, with a three-month treatment period planned.

The company has a clear near-term milestone for data readout from the Parkinson's trial, projecting topline data in the April/May time frame of 2026. The Alzheimer's Phase 3 trial initiation was targeted for late 2025.

Here's a snapshot of the active patient engagement and data timelines:

Program	Trial Phase	Target Enrollment (Approx.)	Key Enrollment/Data Milestone
Bezisterim (Parkinson's)	Phase 2 (SUNRISE-PD)	Not specified, but enrollment picked up quickly	Projected full enrollment by end of 2025; Topline data by April/May 2026
Bezisterim (Long COVID)	Phase 2 (ADDRESS-LC)	Approximately 200 patients	IND authorized by FDA in July 2025; 3-month treatment period
Bezisterim (Alzheimer's)	Phase 3	Not specified	Initiation planned for late 2025

Investor relations via webinars and public disclosures (e.g., December 2025 webinar)

Investor communication is frequent and structured, often through third-party hosts like RedChip Companies. BioVie Inc. (BIVI) scheduled an exclusive live Investor Webinar and Q&A Session for December 9, 2025, following a previous one on October 8, 2025. These events are used to update the market on progress, such as the advancement of bezisterim and BIV201. The company also executed public financing, closing a $12 Million public offering on August 11, 2025. Importantly, management stated that the company has sufficient cash runway to last through the end of 2026.

The cadence of these interactions is high:

• Webinar on December 9, 2025 (Scheduled).
• Webinar on October 8, 2025 (Recent).
• KOL Webcast on May 28, 2025.
• KOL Webcast on April 10, 2025.

Close regulatory relationship with the FDA for development path guidance

The relationship with the U.S. Food and Drug Administration (FDA) is crucial for charting the path for both bezisterim and BIV201. For BIV201, which treats refractory ascites-a condition with a 50% mortality rate within 12 months and no FDA-approved therapies-the company has FDA Fast Track status. As of the November 2025 timeframe, the protocol for the BIV201 Phase 3 clinical trial had been submitted to the FDA about three weeks prior, with an expectation to hear back within 30 days. This close interaction is necessary to finalize the development path for a first-in-class therapy. Furthermore, the FDA authorized the IND application for bezisterim in Long COVID in July 2025, directly enabling that Phase 2 trial to commence.

Finance: draft 13-week cash view by Friday.

BioVie Inc. (BIVI) - Canvas Business Model: Channels

Clinical trial sites are the primary physical channel for BioVie Inc. (BIVI) drug delivery and testing as of late 2025. The Phase 2 SUNRISE-PD trial for bezisterim in Parkinson's Disease is enrolling patients, with topline data anticipated in late 2025 or early 2026. This trial utilizes a decentralized design, allowing for remote participation alongside visits to a clinical site. The Phase 2 ADDRESS-LC trial for Long COVID, which commenced patient enrollment on May 15, 2025, involves approximately 200 patients. BioVie Inc. advances its pipeline through clinical research organizations across the United States and Canada.

Data dissemination channels rely heavily on scientific forums and regulatory disclosures. A poster detailing the SUNRISE-PD trial was presented at the Advanced Therapeutics in Movement & Related Disorders® Congress in National Harbor, MD, between June 27 and June 30, 2025. Furthermore, BioVie Inc. presented 'Bezisterim Epigenetic Effects on Aging and Neurodegeneration' at the 7th World Aging and Rejuvenation Conference (ARC-2025) in Vienna, Austria, on July 9th - 10th, 2025. The company's revenue remained at $0.0 for the trailing twelve months ending September 30, 2025, consistent with its clinical-stage focus.

Capital access is channeled through public markets and regulatory filings. BioVie Inc. trades on NASDAQ under the ticker BIVI. In August 2025, the company closed an underwritten public offering of 6,000,000 units at $2.00 per unit, generating gross proceeds of approximately $12 million. The warrants issued in this offering are exercisable at $2.50 per share. As of the September 30, 2025, SEC filing, cash and cash equivalents stood at $25.0 million, following net proceeds of $15.7 million from equity offerings and $2.9 million from warrant exercises in the nine months prior to March 31, 2025. The company also secured a $13.1 million grant from the U.S. Department of Defense for the Long COVID program.

Future distribution channels are currently being established through partnership discussions, particularly for the BIV201 program for ascites. The BIV201 Phase 3 study is in final preparations, contingent upon identifying a suitable partner. BioVie Inc. is also continuing geographic partnering discussions for bezisterim. The company reported operating expenses for Q3 2025 of $5.3 million (R&D $2.9 million; G&A $2.3 million), with a net loss of $5.1 million for that quarter.

The following table summarizes key financial and operational metrics relevant to channel funding and activity as of late 2025:

Metric Category	Channel Relevance	Value as of Late 2025	Reporting Period/Date
Capital Raised (Aug 2025 Offering)	Investor Relations/Capital Access	$12 million Gross Proceeds	August 11, 2025
Cash & Equivalents	Clinical Trial Funding Runway	$25.0 million	September 30, 2025
Long COVID Trial Funding Source	Clinical Trial Sites/Testing	$13.1 million DoD Grant	Secured prior to May 2025
PD Trial Funding Source	Clinical Trial Sites/Testing	Over $15 million	Secured prior to November 2024
Long COVID Trial Patient Count	Clinical Trial Sites/Testing	Approximately 200 Patients	Phase 2 ADDRESS-LC
Scientific Conference Presentation	Data Dissemination	Advanced Therapeutics in Movement & Related Disorders® Congress	June 27-30, 2025
SEC Form Filed for Offering	Investor Relations/Capital Access	Form S-1 (File No. 333-288525)	August 7, 2025
Warrant Exercise Price	Investor Relations/Capital Access	$2.50 per share	August 2025 Offering

The company's equity incentive plan was amended to authorize 3,100,000 shares for issuance as of November 10, 2025, supporting compensation for key personnel involved in channel execution.

BioVie Inc. (BIVI) - Canvas Business Model: Customer Segments

You're looking at the patient populations and capital providers that form the foundation of BioVie Inc.'s commercial focus as of late 2025. It's a high-stakes environment, where clinical trial milestones directly translate to investor sentiment.

Patients with newly diagnosed Parkinson's Disease (PD)

This segment is being targeted with bezisterim in the Phase 2 SUNRISE-PD clinical trial, which is designed to evaluate the drug's effect on motor and non-motor symptoms in patients who have not yet started carbidopa/levodopa treatment. Enrollment for this trial, which involves approximately 60 patients, was anticipated to begin in early 2025, with topline data expected by the end of 2025.

Patients with mild-to-moderate Alzheimer's Disease (AD)

BioVie Inc. is focused on the estimated six million Americans suffering from Alzheimer's disease. The company is preparing to initiate a Phase 3 trial for bezisterim in this population in late 2025, utilizing a new once-daily formulation. Data presented in July 2025 from the prior Phase 3 study analysis showed treated patients experienced biological age deceleration of up to 4.24 years across various biological clocks after 30 weeks of treatment compared to placebo.

Individuals with neurological symptoms of Long COVID

This segment is being addressed via the Phase 2 ADDRESS-LC study, which is evaluating bezisterim's efficacy in reducing symptoms like 'brain fog' and fatigue in approximately 200 patients. This trial is fully funded by a U.S. Department of Defense grant totaling $13.1 million, with enrollment expected to start in early 2025 and top-line results anticipated by early 2026. The condition itself is believed to affect over 17 million Americans.

Patients with liver cirrhosis and refractory ascites (Orphan Drug market)

The investigational drug BIV201 targets this serious unmet need and has secured both Orphan Drug and Fast Track designations from the FDA. The company is finalizing the protocol for a Phase 3 study, pending identification of a suitable partner. The broader Global Ascites Market was valued at USD 23,556 million in 2025. The Global Orphan Drugs Market overall is predicted to reach USD 669.5 Billion by 2034 from a 2024 valuation of USD 213.6 Billion.

The specific patient population for BIV201 is a niche within the larger ascites market, which is driven by the rising geriatric population, where the U.S. population aged 65 and older was 19.2% in 2024.

Indication Segment	Key Trial/Designation Status (Late 2025)	Patient/Market Size Data Point
Parkinson's Disease (Early)	Phase 2 SUNRISE-PD enrolling; Topline data by end of 2025	Trial size of approximately 60 patients
Mild-to-Moderate Alzheimer's Disease	Phase 3 trial protocol finalizing for late 2025 initiation	Estimated six million Americans affected
Long COVID Neurological Symptoms	Phase 2 ADDRESS-LC enrolling (funded by $13.1 million DoD grant)	Condition affects over 17 million Americans
Liver Cirrhosis/Refractory Ascites	BIV201 has Orphan Drug designation; Phase 3 finalizing	Global Ascites Market valued at USD 23,556 million in 2025

Institutional and retail investors funding the pipeline

You are looking at a company with zero revenue, so the investor base is funding the pipeline based on clinical milestones. As of November 7, 2025, the stock price was $1.48, resulting in a Market Capitalization of $11.2M, or $11.35M as of December 2, 2025, on 7.54M shares outstanding. For the fiscal year ending June 30, 2025, BioVie Inc. reported a net loss of approximately $17.5 million, which was an improvement from the $32.1 million loss in FY2024, largely due to R&D expenses falling to $9.3 million from $23.1 million the prior year. The company held $17.5 million in cash and cash equivalents as of June 30, 2025, and raised approximately $18.9 million through equity offerings during FY2025. The trailing twelve-month Earnings Per Share (EPS) as of September 30, 2025, was -$12.12. Wall Street analysts currently assign a Moderate Buy consensus rating with an average one-year price target of approximately $6.33.

• Trailing 12-Month Revenue (as of 30-Sep-2025): null
• FY 2025 Total Operating Expenses: $18.1 million
• Total Assets (as of 30-Sep-2025): $21.56 million
• Debt-to-Equity Ratio (MRQ 2025): Approximately 0.01
• Current Ratio (as of 30-Sep-2025): 15.83x

The clear action here is to treat BioVie Inc. as a high-risk, high-reward biotech stock. Finance: draft 13-week cash view by Friday.

BioVie Inc. (BIVI) - Canvas Business Model: Cost Structure

You're looking at the core cash outflows for BioVie Inc. as of late 2025, driven almost entirely by clinical development and corporate upkeep since the company remains pre-revenue. The total operating expenses for the fiscal year ending June 30, 2025, were approximately $18.1 million.

The largest single component of the cost base is Research and Development (R&D). For the fiscal year 2025, BioVie Inc. reported Research and Development (R&D) expenses of approximately $9.3 million. This figure represented a significant reduction from the $23.1 million reported the prior year, reflecting completed clinical trials and workforce adjustments.

Here's a breakdown of the major annual cost line items based on the full-year 2025 report:

Cost Category	FY 2025 Amount (Approximate)
Research and Development (R&D) Expenses	$9.3 million
Selling, General, and Administrative (G&A) Expenses	$8.6 million
Total Operating Expenses	$18.1 million

Clinical trial operations and site management costs are embedded within the R&D expenses, but specific standalone figures aren't broken out in the high-level summaries. Still, the R&D spend reflects the costs of advancing bezisterim (NE3107) for Parkinson's disease and Long COVID indications, plus preparations for the BIV201 Phase 3 study in liver disease.

General and Administrative (G&A) expenses, covering executive salaries and corporate overhead, were reported around $8.6 million for the full year 2025. For context, the Selling, General, and Administrative expenses for the third quarter of FY2025 alone were $1.6 million.

Intellectual property maintenance and legal fees fall under the G&A structure, but specific amounts for these items aren't itemized separately in the available annual summaries. These costs are necessary to maintain the patent estate for bezisterim and BIV201.

Costs associated with capital raising are a recurring, non-operational cash outflow. You saw a significant financing event in August 2025:

• Gross proceeds expected from the August 2025 underwritten public offering were approximately $12 million, before deducting underwriting discounts and commissions and other estimated offering expenses.
• For the nine months ending March 31, 2025, the company raised net proceeds of $15.7 million from equity offerings.
• During that same nine-month period, proceeds from warrant exercises totaled $2.9 million.
• The company also fully repaid its $5 million notes payable during the nine months ending March 31, 2025.

The company's cash position as of June 30, 2025, was $17.5 million in cash and cash equivalents, with a net change in cash for the year of negative $6.29 million.

Finance: draft 13-week cash view by Friday.

BioVie Inc. (BIVI) - Canvas Business Model: Revenue Streams

You're looking at the current financial lifeblood of BioVie Inc. (BIVI) as of late 2025, and honestly, it's what you'd expect from a clinical-stage company deep in development: revenue streams are almost entirely non-operational right now. The core business isn't selling products yet; it's securing funding to push its pipeline forward.

For the fiscal year ending June 30, 2025, product revenue was $0.00. That's the reality when you're pre-commercialization. This means the company is entirely reliant on external capital to fund its research and development (R&D) expenses, which were significant, with a net loss of approximately $17.54 million for that same fiscal year.

The most recent, concrete cash infusion came from equity financing. In August 2025, BioVie Inc. closed a public offering, raising approximately $12 million in gross proceeds. This involved selling units comprised of common stock and warrants, a move that clearly signals a trade-off: reducing immediate credit risk but increasing shareholder dilution. To be fair, the net proceeds after deducting underwriting discounts and commissions were closer to $10.5 million.

A critical, non-dilutive source of funding is the grant money tied to clinical progress. BioVie Inc. was awarded up to $13.1 million in non-dilutive funding from the U.S. Department of Defense (DOD) to evaluate bezisterim for neurological symptoms associated with Long COVID. This total award is structured, with an initial $499,200 provided for the planning phase, and the remaining $12.6 million contingent upon successfully executing the Phase 2b clinical trial. This is defintely a key non-equity source that helps extend the cash runway.

Here's a quick look at the concrete financial inflows that make up the current revenue stream profile:

Revenue Stream Category	Specific Item	Reported Amount (USD)	Status/Notes
Product Sales	FY Ended June 30, 2025 Product Revenue	$0.00	Zero revenue from commercial product sales.
Equity Financing	Gross Proceeds from August 2025 Public Offering	Approximately $12 million	Raised by selling units of stock and warrants.
Equity Financing	Net Proceeds from August 2025 Public Offering	Approximately $10.5 million	Actual cash received after fees.
Non-Dilutive Grant Funding	Total Potential U.S. DOD Grant (Long COVID)	Up to $13.1 million	Contingent on trial milestones.
Non-Dilutive Grant Funding	Initial DOD Planning Phase Funding	$499,200	Initial tranche received.
Non-Dilutive Grant Funding	DOD Clinical Trial Portion (Option)	$12.6 million	Contingent upon trial progress.

Looking ahead, the model anticipates two major, currently unrealized revenue streams, both contingent on clinical success and partnership activity. These are:

• Future milestone payments derived from any in-licensing agreements that BioVie Inc. might secure post-data readout for its drug candidates.
• Future royalties and product sales revenue, which only materialize if a drug candidate achieves full regulatory approval and subsequent commercial launch.

Finance: draft 13-week cash view by Friday.