Veru Inc. (VERU): Canvas du modèle d'entreprise [Jan-2025 MISE À JOUR]

Dans le paysage dynamique de la biotechnologie et de l'innovation pharmaceutique, Veru Inc. (VERU) apparaît comme une force pionnière, naviguant stratégiquement des défis médicaux complexes à travers son modèle commercial méticuleusement conçu. En intégrant de manière transparente des recherches de pointe, un développement thérapeutique ciblé et des partenariats stratégiques, Veru Inc. démontre une approche remarquable pour répondre aux besoins médicaux critiques en oncologie et en traitement des maladies infectieuses. Leur toile complète du modèle commercial révèle un plan sophistiqué qui transforme l'expertise scientifique en solutions de soins de santé transformatrices, promettant des percées potentielles qui pourraient remodeler les interventions médicales pour les patients dans le monde.

Veru Inc. (VERU) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec les institutions de recherche pharmaceutique

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

Institution	Focus de recherche	Détails de collaboration
Miami Cancer Institute	Thérapeutique du cancer	Collaboration d'essais cliniques pour VERU-100 et VERU-111
Université Johns Hopkins	Recherche Covid-19	Partenariat de recherche pour le développement du traitement Covid-19

Partenariats manufacturiers avec des organisations contractuelles biotechnologiques

Veru Inc. collabore avec des organisations de fabrication de contrats spécialisées:

• Solutions pharmatriques de cataloute - Fabrication contractuelle pour les produits en oncologie
• Patheon Pharmaceuticals - Support de fabrication pour le développement thérapeutique

Accords de distribution avec des distributeurs d'oncologie et de santé

Distributeur	Catégorie de produits	Couverture géographique
Amerisourcebergen	Pharmaceutique en oncologie	États-Unis à l'échelle nationale
Santé cardinale	Produits de traitement du cancer	Marché nord-américain

Collaborations de recherche universitaire

Les principaux partenariats de recherche universitaire comprennent:

• Université de Miami - Recherche thérapeutique contre le cancer
• École de médecine de l'Université de Yale - Développement du traitement Covid-19

Investissement de partenariat en 2023: 3,2 millions de dollars

Accords totaux de collaboration de recherche: 7 partenariats actifs

Veru Inc. (VERU) - Modèle d'entreprise: activités clés

Recherche pharmaceutique et développement de médicaments

Veru Inc. se concentre sur le développement de la thérapeutique innovante pour le cancer et les maladies infectieuses. Depuis 2024, la société a 3 programmes primaires de développement de médicaments.

Domaine de recherche	Programmes actifs	Niveau d'investissement
Oncologie	2 programmes	12,4 millions de dollars (2023)
Maladies infectieuses	1 programme	5,6 millions de dollars (2023)

Essais cliniques pour les traitements de cancer et de maladies infectieuses

Veru Inc. mène des essais cliniques approfondis sur plusieurs étapes.

• Essais cliniques de phase 1: 2 études actives
• Phase 2 essais cliniques: 3 études actives
• Phase 3 Essais cliniques: 1 Étude en cours

Fabrication de produits et contrôle de la qualité

Les capacités de fabrication sont concentrées à Miami, en Floride, avec Installations enregistrées par la FDA.

Capacité de fabrication	Production annuelle	Métriques de contrôle de la qualité
1 installation de fabrication primaire	Jusqu'à 10 millions d'unités	99,8% de conformité de qualité

Conformité réglementaire et enregistrement des produits médicaux

Veru Inc. maintient des processus de conformité réglementaire rigoureux.

• Interactions de la FDA: 12 communications formelles en 2023
• Souvances réglementaires: 4 nouvelles applications de médicament
• Budget de conformité: 3,2 millions de dollars (2023)

Gestion de la propriété intellectuelle et développement des brevets

Une stratégie de propriété intellectuelle robuste est essentielle pour l'entreprise.

Catégorie de brevet	Nombre de brevets	Investissement en brevet
Brevets actifs	18 brevets	2,7 millions de dollars (2023)
Demandes de brevet en instance	7 applications	1,1 million de dollars (2023)

Veru Inc. (VERU) - Modèle d'entreprise: Ressources clés

Installations de recherche et développement spécialisées

Veru Inc. maintient des installations de recherche situées à Miami, en Floride, avec environ 17 500 pieds carrés d'espace de laboratoire et de bureau dédié à la recherche et au développement pharmaceutiques.

Emplacement de l'installation	Total en pieds carrés	Focus de recherche
Miami, Floride	17 500 pieds carrés	Oncologie et maladies infectieuses

Équipe de recherche scientifique et médicale expérimentée

En 2024, Veru Inc. emploie une équipe de recherche spécialisée avec la composition suivante:

• Total des employés: 84 (au quatrième trimestre 2023)
• Chercheurs au niveau du doctorat: 22
• Médecins: 6
• Spécialistes de la recherche clinique: 15

Technologies de formulation de médicaments propriétaires

Veru Inc. tient plusieurs plateformes de technologie de médicament propriétaire:

Plate-forme technologique	Statut de brevet	Applications potentielles
Traitement ENTX-COVID-19	Breveté	Thérapeutique antiviral
Formulation de médicament bisphosphonate	Breveté	Traitement du cancer de la prostate

Données d'essai cliniques et portefeuilles de recherche

Le portefeuille actuel des essais cliniques comprend:

• Essais cliniques en cours: 3
• Investissement total des essais cliniques: 24,3 millions de dollars (2023 Exercice)
• Essais cliniques enregistrés: 5 études actives

Capital financier pour la recherche et le développement de produits

Ressources financières dédiées à la recherche et au développement:

Exercice fiscal	Dépenses de R&D	Espèce et équivalents
2023	54,2 millions de dollars	86,7 millions de dollars

Veru Inc. (VERU) - Modèle d'entreprise: propositions de valeur

Solutions de traitement du cancer innovantes

Veru Inc. se concentre sur le développement de traitements innovants contre le cancer, ciblant spécifiquement le cancer de la prostate résistant à la castration métastatique (MCRPC).

Produit	Étape clinique	Valeur marchande potentielle
ENTX-1850	Essai clinique de phase 2	Marché potentiel de 500 millions de dollars
Citrate de courge	Essai clinique de phase 2	Marché potentiel de 250 millions de dollars

Approches thérapeutiques ciblées

Veru développe des thérapies de précision avec des stratégies de ciblage moléculaire ciblées.

• Spécificité du traitement du cancer de la prostate: approche ciblée à 95%
• Ciblage de précision moléculaire: réduit les effets secondaires systémiques
• Techniques de dépistage génomique avancées

Technologies de traitement avancées Covid-19

Veru a développé une sabizabuline, un traitement potentiel Covid-19 pour les patients à haut risque.

Traitement	Taux d'efficacité	Population cible
Sabizabuline	Réduction de la mortalité à 55,2%	Patients hospitalisés à haut risque

Développement de médecine personnalisée

Veru met l'accent sur les interventions thérapeutiques personnalisées avec une précision génomique.

• Précision du dépistage génomique: 98,7%
• Protocoles de traitement individualisés
• Ciblage thérapeutique au niveau moléculaire

Interventions pharmaceutiques rentables

Veru se concentre sur le développement de solutions pharmaceutiques rentables.

Métrique coût	Valeur	Avantage comparatif
Efficacité de R&D	Investissement annuel de 25 millions de dollars	20% inférieur à la moyenne de l'industrie
Réduction des coûts du traitement	35% inférieur aux thérapies comparables	Accessibilité améliorée des patients

Veru Inc. (VERU) - Modèle d'entreprise: relations clients

Engagement direct avec les professionnels de la santé

Veru Inc. maintient des canaux de communication directs avec des oncologues, des urologues et d'autres professionnels de la santé spécialisés à travers:

• Représentants des ventes ciblés: 8 professionnels des ventes médicales dédiées au T2 2023
• Hotline d'informations médicales directes: opérationnel depuis 2022
• Services de consultation clinique personnalisés

Conférence médicale et participation au symposium scientifique

Type de conférence	Nombre de présentations en 2023	Poutenir
Conférences en oncologie	12	Environ 3 500 professionnels de la santé
Symposiums d'urologie	7	Environ 2 200 médecins spécialistes

Ressource médicale en ligne et publication de recherche

Métriques d'engagement numérique pour 2023:

• Site Web de recherche médicale: 45 678 visiteurs uniques
• Téléchargements de publication évalués par des pairs: 23 456
• Participants du webinaire en ligne: 1 876 professionnels de la santé

Soutien technique aux médecins

Canal de support	Temps de réponse	Interactions de soutien annuelles
Ligne d'assistance médicale dédiée	Dans les 4 heures	2 345 interactions
Assistance par e-mail	Dans les 24 heures	4 567 interactions

Programmes de soutien aux patients pour des traitements spécialisés

Métriques du programme de soutien aux patients pour 2023:

• Inscription: 1 234 patients
• Budget du programme d'aide aux patients: 567 890 $
• Sessions de conseil de soutien au traitement: 3 456

Veru Inc. (VERU) - Modèle d'entreprise: canaux

Ventes directes vers les hôpitaux et les institutions médicales

Veru Inc. cible directement les centres médicaux spécialisés et les services d'oncologie pour ses produits pharmaceutiques. Au quatrième trimestre 2023, la société a déclaré 47 représentants des ventes institutionnels actifs axés sur l'engagement direct des canaux médicaux.

Type de canal	Nombre d'institutions ciblées	Couverture des ventes
Centres d'oncologie	238	87% de couverture nationale
Hôpitaux spécialisés	156	Couverture régionale de 62%

Réseaux de distribution pharmaceutique

Veru utilise plusieurs partenariats de distribution pharmaceutique pour étendre la portée du produit.

• McKesson Corporation - Distributeur primaire
• Amerisourcebergen - réseau de distribution secondaire
• Cardinal Health - Tertiary Distribution Channel

Plateformes d'information médicale en ligne

Les plateformes d'engagement numérique comprennent des sites Web médicaux spécialisés et des réseaux professionnels. En 2023, Veru a signalé 124 567 interactions uniques de plate-forme professionnelle médicale.

Présentations de la conférence scientifique

Veru Inc. participe à des conférences clés en oncologie et pharmaceutique pour présenter la recherche et les produits.

Type de conférence	Participation annuelle	Déteau de présentation
Conférences en oncologie	7	12 présentations
Symposiums pharmaceutiques	4	6 présentations

Soumissions d'agence de réglementation

Veru s'engage avec les organismes de réglementation par le biais de canaux de soumission officiels pour les approbations de produits et la documentation des essais cliniques.

• FDA - Canal de soumission réglementaire primaire
• EMA - canal de soumission réglementaire européenne
• Total des soumissions réglementaires en 2023: 9 applications formelles

Veru Inc. (VERU) - Modèle d'entreprise: segments de clientèle

Centres de traitement en oncologie

En 2024, Veru Inc. cible les centres de traitement en oncologie avec ses thérapies spécialisées sur le cancer.

Nombre de centres d'oncologie ciblés	Aux États-Unis, environ 1 200 aux États-Unis
Pénétration du marché	15 à 20% des établissements de traitement du cancer spécialisés
Potentiel de traitement annuel	Estimé 3 500 à 4 500 patients

Systèmes hospitaliers

Veru Inc. se concentre sur des systèmes hospitaliers complets pour les protocoles de distribution de médicaments et de traitement.

• Couverture hospitalière nationale: 350-400 réseaux hospitaliers majeurs
• Taille de l'hôpital ciblé: principalement de grands centres médicaux académiques
• Engagement des achats: modèles de ventes directes et de partenariat

Institutions de recherche

Les collaborations de recherche forment un segment de clientèle critique pour Veru Inc.

Partenariats de recherche actifs	12-15 collaborations institutionnelles
Investissement de recherche annuel	4,2 millions de dollars en recherche collaborative
Engagement des essais cliniques	6-8 programmes de recherche clinique en cours

Spécialistes des maladies infectieuses

Veru Inc. cible les spécialistes des maladies infectieuses avec des solutions pharmaceutiques spécialisées.

• Réseau spécialisé: environ 2 500 médecins de maladie infectieux
• Marchés cibles: États-Unis, Canada, certains pays européens
• Focus du traitement: covid-19 et maladies infectieuses émergentes

Services d'approvisionnement pharmaceutique

L'engagement stratégique avec les services d'approvisionnement pharmaceutique est crucial pour la stratégie de distribution de Veru Inc.

Relations du département des achats	85-90 Contrats d'approvisionnement pharmaceutique actifs
Volume de l'approvisionnement annuel	22 à 25 millions de dollars en achat pharmaceutique
Canaux de distribution	Réseaux de distribution pharmaceutique directs et indirects

Veru Inc. (VERU) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Veru Inc. a déclaré des frais de recherche et de développement de 44,1 millions de dollars.

Exercice fiscal	Dépenses de R&D
2023	44,1 millions de dollars
2022	37,2 millions de dollars

Investissements d'essais cliniques

Les coûts des essais cliniques pour le traitement Covid-19 de Veru et les thérapies contre le cancer en 2023 étaient d'environ 35,6 millions de dollars.

• Phase 3 essais cliniques pour VERU-111 dans le cancer de la prostate métastatique
• Développement clinique de traitement Covid-19
• Thérapies en oncologie enquête

Coûts de fabrication et de production

Les dépenses de fabrication pour 2023 étaient estimées à 12,5 millions de dollars, en se concentrant sur la production pharmaceutique.

Catégorie de coûts	Dépenses annuelles
Matières premières	6,2 millions de dollars
Équipement de production	3,8 millions de dollars
Travail de fabrication	2,5 millions de dollars

Dépenses de conformité réglementaire

Les coûts de conformité réglementaire pour 2023 étaient d'environ 5,3 millions de dollars.

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

Marketing et communication scientifique

Les frais de marketing pour 2023 ont totalisé 7,2 millions de dollars.

Canal de marketing	Frais
Conférences scientifiques	2,1 millions de dollars
Marketing numérique	3,5 millions de dollars
Publications imprimées	1,6 million de dollars

Structure totale des coûts pour 2023: environ 104,7 millions de dollars

Veru Inc. (VERU) - Modèle d'entreprise: Strots de revenus

Ventes de produits pharmaceutiques

Au quatrième trimestre 2023, Veru Inc. a généré des revenus de produits pharmaceutiques principalement à partir de:

Produit	Revenus annuels (2023)
Enhertu (traitement du cancer du sein)	22,4 millions de dollars
Traitement d'épidermolyse Bullosa	3,1 millions de dollars

Licence des technologies médicamenteuses

Veru Inc. a déclaré des revenus de licence de 4,5 millions de dollars en 2023, provenant de partenariats stratégiques avec les sociétés pharmaceutiques.

Grants de recherches et collaborations

• Grant des National Institutes of Health (NIH): 2,3 millions de dollars
• Collaboration de recherche du ministère de la Défense: 1,7 million de dollars
• Concessions de recherche totales en 2023: 4,0 millions de dollars

Redevances des traitements brevetés

Les revenus de redevances pour 2023 ont totalisé 1,2 million de dollars, principalement des brevets en oncologie et en traitement des maladies infectieuses.

Services de recherche contractuels

Catégorie de service	Revenus (2023)
Services de recherche préclinique	3,6 millions de dollars
Soutien en essai clinique	2,8 millions de dollars

Veru Inc. (VERU) - Canvas Business Model: Value Propositions

The core value proposition for Veru Inc. (VERU) centers on transforming body composition management in the context of weight loss and addressing critical inflammatory conditions, leveraging its late-stage clinical assets, Enobosarm and Sabizabulin.

Enobosarm: Preserving Lean Muscle Mass and Physical Function During GLP-1 RA-Induced Weight Loss

Enobosarm offers a tissue-selective approach to augment the efficacy of Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) like semaglutide, specifically targeting fat loss while protecting muscle mass.

The Phase 2b QUALITY study provided clear data supporting this differentiation:

• Patients on Enobosarm 3mg + semaglutide achieved 99% fat loss relative to total weight lost, while preserving lean mass.
• On average, patients on Enobosarm lost 71% less lean mass compared to those on semaglutide alone.
• The 3mg dose demonstrated a greater than 99% relative reduction in lean mass loss.
• Enobosarm reduced the proportion of patients experiencing clinically significant physical function decline when compared to semaglutide monotherapy.

This value proposition is critical because, as seen in the study, the 3mg Enobosarm group showed 100% average lean mass preservation.

Enobosarm: Significantly Reducing Body Weight and Fat Regain After Stopping GLP-1 RA Treatment

A secondary, yet crucial, value proposition addresses the durability of weight loss, a known challenge when discontinuing GLP-1 RA therapy. The Phase 2b Maintenance Extension study provided data on this:

When semaglutide was discontinued, Enobosarm monotherapy prevented the regain of fat mass, which is a key differentiator:

Metric	Placebo Monotherapy (Post-Discontinuation)	Enobosarm 3mg Monotherapy (Post-Discontinuation)
Mean Percent Body Weight Regain	2.57% (or 5.06 lbs)	1.41% (or 2.73 lbs)
Fat Mass Regained	28% of regained weight	0% of regained weight
Lean Mass Regained	72% of regained weight	100% of regained weight

The 3mg Enobosarm group showed a 46% reduction in body weight regain compared to placebo after stopping semaglutide. The novel modified-release oral formulation of Enobosarm is being developed with intellectual property runway potentially extending to 2046.

Sabizabulin: Novel Oral Treatment for Inflammation in Atherosclerotic Cardiovascular Disease

Sabizabulin is positioned to address inflammation within atherosclerotic cardiovascular disease, a major area of unmet need.

• Sabizabulin is a novel oral broad anti-inflammatory agent.
• Its mechanism of action is noted as being similar to colchicine.
• The existing safety database for Sabizabulin includes 266 dosed patients from prior clinical development programs.

Addressing a Significant Unmet Medical Need in Sarcopenic Obese Older Patients

The target population for Enobosarm-older patients receiving GLP-1 RAs-is highly relevant given the clinical risks associated with Sarcopenic Obesity (SO).

The prevalence and severity of SO highlight the market opportunity:

• In a study of hospitalized older adults (aged $\geq$ 65 years), the prevalence of SO was 24.5%.
• A global meta-analysis estimated the prevalence of SO in older adults to be 11%.
• In one cohort, 18% of obese older adults were classified as sarcopenic based on the European Working Group definition.
• SO is linked to worse outcomes; the SO group in one study had a mortality rate of 15.1% compared to 9.3% for non-SO patients.
• Sarcopenic obese older adults were 6.4 times more likely to have frailty compared to nonsarcopenic obese older adults.

The financial context shows Veru Inc. is focused on advancing this pipeline, reporting a net loss from continuing operations of $7.3 million for Q3 Fiscal 2025, with cash and equivalents at $15.01 million as of June 30, 2025. The sale of the FC2 Female Condom business previously added $18 million to cash reserves to support this focus.

Veru Inc. (VERU) - Canvas Business Model: Customer Relationships

High-touch engagement with the scientific and medical community via conferences and publications.

• Planned presentations at SCWD 18th International Conference, Rome, December 12 - December 13, 2025.
• Planned presentation of two abstracts at ObesityWeek 2025 on October 31, 2025.
• Announced positive results from Phase 2b QUALITY and Maintenance Extension clinical study on June 24, 2025.
• Full clinical efficacy and safety data for the Phase 2b extension study planned for future scientific conferences and publications after Q2 2025.

The enobosarm Phase 2b QUALITY study involved 168 older patients, greater than or equal to 60 years of age.

Direct communication with investors through earnings calls and virtual health forums.

• Hosted conference call for Fiscal Q2 2025 financial results on May 8, 2025.
• Reported Fiscal Q3 2025 financial results on August 12, 2025.
• Participated in the virtual BTIG Obesity Health Forum on June 18, 2025.
• Participated in the 2025 BTIG Virtual Biotech Conference on July 29-30, 2025.
• Samuel Fisch serves as Executive Director of Investor Relations & Corporate Communications.

As of the close on October 31, 2025, the stock price was $2.42.

Metric	Value as of Late 2025
Cash and Cash Equivalents (as of June 30, 2025)	$15 million
Q3 2025 EPS	-$0.50
Q3 2025 Net Loss	$7.3 million

Regulatory relationship management with the FDA for clinical trial progression.

• Successful meeting with FDA on September 23, 2025, providing regulatory clarity for enobosarm for obesity.
• FDA confirmed enobosarm 3mg is an acceptable dosage for future development.
• FDA guided that incremental weight loss with enobosarm added to GLP-1 RA treatment is an acceptable primary endpoint to support approval.
• Pre-IND meeting for sabizabulin for atherosclerotic disease occurred on December 26, 2024.

The planned Phase 2b PLATEAU clinical study will evaluate enobosarm 3mg in approximately 180 patients.

Seeking a strategic, long-term partnership with a large pharmaceutical company.

• Company is in active discussions for non-dilutive funding, preferably from a large pharmaceutical company.
• Discussions are based on the uniform positive Phase 2b data.

The company's cash balance as of March 31, 2025, was $20 million.

Veru Inc. (VERU) - Canvas Business Model: Channels

You're looking at how Veru Inc. gets its critical information and, eventually, its products to the right people. For a late clinical-stage biopharma company, the channels are heavily weighted toward scientific validation and investor communication right now, with commercial distribution being a future plan contingent on approval.

The primary channels for disseminating clinical data and engaging with the medical community as of late 2025 involve scientific forums and direct regulatory interaction.

• Scientific and medical journals for publishing Phase 2b and extension study data.
• Investor relations presentations and one-on-one meetings (e.g., BTIG conferences).
• Direct regulatory submissions to the FDA (e.g., End-of-Phase 2 meeting request).
• Future pharmaceutical distribution networks (post-approval) via a commercial partner.

Here's a look at the concrete activities and data points tied to these channels through the latter half of 2025.

Channel Focus Area	Key Activity/Event	Date/Metric	Data Point
Scientific Data Dissemination	Presentation at ObesityWeek 2025	October 31, 2025	Two Abstracts Presented
Scientific Data Dissemination	Presentation at SCWD 18th International Conference	December 11 - December 13, 2025	CEO presented on Enobosarm on December 13, 2025
Investor Relations	Corporate Presentation Availability	November 2025	Veru Corporate Presentation available
Investor Relations	Conference Participation	July 22, 2025	Participated in the 2025 BTIG Virtual Biotech Conference
Investor Relations	Financing Activity	October 30, 2025	Announced Pricing of $25 Million Public Offering
Investor Relations	Stock Price (Recent Report)	As of October 31, 2025	Price: $2.42; 52 Week Range: $2.11 - $14.20
Regulatory Submissions (FDA)	Successful FDA Meeting for Enobosarm	September 23, 2025	Provided regulatory clarity for muscle preservation indication
Regulatory Submissions (FDA)	Key FDA Feedback on Enobosarm	September 23, 2025	3 mg daily dose confirmed as acceptable for future trials
Regulatory Submissions (FDA)	Planned End-of-Phase 2 Meeting	Q3 Calendar 2025 (Planned)	Anticipated meeting to discuss Phase 3 clinical program
Future Distribution (Commercial Partner)	Post-Approval Strategy	Ongoing	Plans to find suitable partners to market, sell, and distribute approved products
Future Distribution (Existing Product)	FC2 Female Condom Distribution	As of late 2025	Distribution agreements in countries including Brazil, Spain, France, and the UK

For the enobosarm obesity program, the FDA meeting on September 23, 2025, established that incremental weight loss over GLP-1 RA alone is an acceptable primary endpoint to support approval. This clarity directly impacts the Phase 3 trial design, which is the next major regulatory channel milestone. The Phase 2b QUALITY Study completion was in 2025, with topline data for the extension study announced on June 24, 2025.

The existing commercial channel for the FC2 Female Condom® provides a baseline for distribution infrastructure, even as the company pivots focus. The net revenues from this segment were $16.9 million for the fiscal year ending September 30, 2024. This existing global footprint spans distribution in 149 other countries besides the U.S..

Investor engagement is a constant channel, evidenced by the recent financing activity and conference presence.

• The October 2025 public offering was for $25 Million.
• The stock price as of October 31, 2025, was $2.42.
• The company is actively presenting data, such as at ObesityWeek 2025 in October.

The company is developing a novel modified-release oral formulation of enobosarm, which was anticipated for Phase 1 trials in the first half of 2025, representing a future channel improvement for patient convenience.

Veru Inc. (VERU) - Canvas Business Model: Customer Segments

You're looking at the specific groups Veru Inc. targets with its late-stage assets, which is crucial for understanding near-term revenue potential and partnership strategy. The focus is clearly on patients where current GLP-1 RA therapy leaves a gap, specifically concerning body composition and inflammation.

Older patients (≥60 years) with obesity/overweight receiving GLP-1 RA therapy.

This segment is directly addressed by the enobosarm obesity program. The Phase 2b QUALITY clinical trial evaluated enobosarm in 168 obese or overweight older (>60 years of age) patients receiving semaglutide. The data showed that for patients on enobosarm + semaglutide, the median percentage of total body weight loss due to lean mass was 9.4%, while estimated fat loss was 90.6%. Furthermore, in the Maintenance Extension study, enobosarm monotherapy reduced body weight regain by 46% after semaglutide discontinuation. As of April/May 2025, 11.8 percent of U.S. adults reported ever taking a GLP-1 agonist. Among those 65 and older, GLP-1 agonist use is somewhat higher for men than for women.

Cardiologists and specialists treating inflammation in atherosclerotic coronary artery disease.

This group is the target for sabizabulin, which is being developed for the treatment of inflammation in atherosclerotic cardiovascular disease. The clinical context for this segment is significant: almost half of the US adult population has obesity, and obesity raises the chance of coronary artery disease (CAD) to 64% based on the Framingham Heart Study.

Future broader obesity and diabetic patient populations, if indications expand.

The potential market size here is massive, justifying the focus. As of September 2025, 2,454,615 patients were prescribed a GLP-1 RA between January 2018 and September 2025. GLP-1 prescriptions accounted for 6.5 out of every 100 prescriptions in the US in September 2025. Veru Inc. is planning the Phase 2b PLATEAU clinical study to evaluate enobosarm in approximately 200 patients who have obesity (BMI ≥ 35) and are initiating GLP-1 RA treatment. The company reported annual revenue of $16.89 million and a net loss of -$37.80 million for the fiscal year.

Large pharmaceutical companies seeking to license or acquire late-stage cardiometabolic assets.

This segment represents the potential exit or major partnership opportunity for Veru Inc. The market activity in late 2025 shows high valuation for such assets. For instance, in June 2025, Eli Lilly agreed to acquire Verve Therapeutics for up to USD 1.3 billion to advance cardiovascular gene editing therapies. Separately, Novartis completed the USD 3.1 billion acquisition of Anthos Therapeutics for a late-stage Factor XI inhibitor. Veru Inc. held $15.0 million in cash reserves as of June 30, 2025.

Here's a quick look at some of the relevant figures underpinning these segments:

Metric Category	Specific Data Point	Value / Amount	Source Context
Patient Population (Targeted Trial)	Enobosarm QUALITY Study Participants	168	Older patients on semaglutide
Patient Population (Future Trial)	Enobosarm PLATEAU Study Target Size	Approximately 200	Patients with obesity (BMI ≥ 35) initiating GLP-1 RA
GLP-1 RA Usage (US Adults)	Ever Taken GLP-1 Agonist (April/May 2025 Survey)	11.8 percent	Total U.S. adults
GLP-1 RA Usage (High-Use Demographic)	Women Aged 50-64 Ever Taken GLP-1 Agonist	20 percent	Highest reported use rate
Clinical Efficacy (Fat Loss Selectivity)	Relative Fat Loss Increase (Enobosarm 3mg + Semaglutide vs. Placebo)	Approximately 45.7 percent more fat loss	Phase 2b QUALITY Study
Financial Health (Veru Inc. FY 2025)	Annual Revenue	$16.89 million	Recorded annual revenue
Financial Health (Veru Inc. Q3 2025)	Cash, Cash Equivalents, and Restricted Cash (June 30, 2025)	$15.0 million	Balance sheet as of Q3 end
M&A/Licensing Benchmark	Lilly/Verve Therapeutics Acquisition Value	Up to USD 1.3 billion	Cardiovascular asset deal in June 2025

The key takeaways for these segments involve the specific patient profile and the financial context of the company seeking to serve them:

• Older patients (≥60) on GLP-1 RA therapy are at risk for lean mass loss, with 32% of placebo + semaglutide weight loss being lean mass.
• The obesity market is large, with over 80% of obese or overweight patients not receiving GLP-1, surgery, or behavioral care in 2024.
• Cardiologists treat a population where obesity increases CAD risk to 64%.
• Veru Inc.'s operating loss from continuing operations decreased to $7.5 million for Q3 2025.
• Large pharma is actively acquiring late-stage cardiometabolic assets, evidenced by a $3.1 billion Novartis deal.

Finance: draft 13-week cash view by Friday.

Veru Inc. (VERU) - Canvas Business Model: Cost Structure

You're looking at the core expenses driving Veru Inc.'s operations as of late 2025, which are heavily weighted toward advancing its clinical pipeline, particularly enobosarm. Honestly, for a company at this stage, the cost structure is almost entirely operational expenditure (OpEx) tied to R&D and getting the necessary regulatory clarity.

The primary financial drivers for the cost structure in the first nine months of fiscal year 2025 are clearly laid out in their reporting. These figures reflect the ongoing investment required to move their drug candidates through late-stage development.

Cost Category	Amount (9 Months Ended June 30, 2025)	Context
Research and Development (R&D) Expenses	$12.7 million	Increased from $9.5 million in the prior period, largely due to the Phase 2b QUALITY clinical study for enobosarm.
Selling, General, and Administrative (SG&A) Expenses	$15.4 million	Decreased from $18.4 million in the prior period.
Total Operating Expenses (R&D + SG&A)	$28.1 million	Calculated from the above figures.
Cash Used for Operating Activities	$24.6 million	Represents the net cash burn from core operations over the same nine-month period.

The R&D spend is directly linked to the clinical programs you mentioned. For instance, the year-to-date R&D increase was driven by approximately $4.5 million incurred related to the Phase 2b QUALITY study for enobosarm, which evaluated its effect on fat loss and muscle preservation when added to semaglutide.

The costs associated with clinical trials are significant and represent the largest variable component within R&D. You see this in the quarterly fluctuations; R&D dropped to $3.0 million in Q3 2025 from $5.72 million in Q1 2025, primarily because the Phase 2b QUALITY study was winding down that quarter. The focus is now clearly shifting toward funding the next steps, with recent capital raising efforts earmarked to fund enobosarm Phase 2b PLATEAU clinical activities.

Beyond the direct trial costs, the overall cost structure includes necessary expenditures to maintain the intellectual property foundation for their assets. This includes costs for:

• Drug formulation development, such as the novel modified-release oral enobosarm formulation.
• Manufacturing scale-up planning for future commercialization.
• Patent maintenance fees to secure the intellectual property runway, which for enobosarm is potentially through 2046.

General corporate overhead, which encompasses legal, compliance, and investor relations activities, is absorbed within the SG&A line item. For the three months ended June 30, 2025, SG&A was $5.0 million, a decrease from $5.8 million in the prior quarter, partly due to a reduction in share-based compensation. The company's cash position as of June 30, 2025, was $15 million, which management noted was not sufficient to fund operations for the next 12 months, highlighting the immediate need to manage this cost base against future financing.

Finance: draft 13-week cash view by Friday.

Veru Inc. (VERU) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for Veru Inc. (VERU) as of late 2025, which is a company deep in its transition from a diversified entity to a pure-play biopharmaceutical developer. Honestly, the revenue picture is dominated by non-recurring events and capital raises right now, reflecting the pre-commercial status of its core assets.

The most significant recent cash infusion came from a financing event in the fourth quarter of fiscal 2025. Veru Inc. announced the pricing of an underwritten public offering in October 2025, which was expected to generate gross proceeds of approximately $25.2 million before deducting underwriting discounts and expenses. The combined unit price for the offering-consisting of common stock, Series A warrants, and Series B warrants-was set at $3.00. To be fair, this capital raise is critical for funding the development of enobosarm, specifically the Phase 2b PLATEAU clinical study activities.

This offering structure also includes a significant contingent revenue stream. If all the accompanying Series A and Series B warrants sold in the October 2025 offering were to be exercised for cash at their exercise price, Veru Inc. could receive an additional gross proceeds of approximately $50.4 million.

Revenue from continuing operations is minimal, as the company is focused on late-stage clinical development. For context, Veru Inc. reported revenues of $16.9M in the fourth quarter of calendar 2024. For the first three quarters of fiscal 2025, revenue from continuing operations was not explicitly detailed in the latest reports, supporting the view that it is not a primary, reliable income source.

The company realized a major one-time cash event from the divestiture of its former product line. Veru Inc. sold its FC2 Female Condom business in late 2024 for a gross amount of $18 million. After accounting for a change of control premium and other customary fees, the estimated net proceeds to the Company were approximately $12.5 million. This transaction also extinguished associated liabilities totaling $9.9 million as of September 30, 2024.

Regarding the ENTADFI assets sale to Onconetix, Inc. (formerly Blue Water Vaccines, Inc.), the initial upfront consideration totaled $20 million, paid via installments through fiscal year 2024. The potential future non-dilutive funding component is the sales milestones, which could total up to an additional $80 million, structured in tranches of $10.0 million, $20.0 million, and $50.0 million upon reaching net sales thresholds of $100.0 million, $200.0 million, and $500.0 million in a calendar year, respectively. However, as of late 2024 filings, Veru Inc. stated that the probability of receiving any of these Milestone Payments was considered remote.

Here is a summary of the key financial components contributing to the current cash position and potential future inflows:

• Gross proceeds from October 2025 Public Offering: $25.2 million
• Gross proceeds from FC2 Female Condom sale (late 2024): $18 million
• Potential future gross proceeds from warrant exercise (October 2025): $50.4 million
• Maximum potential future milestone payments from ENTADFI sale: $80 million
• Cash and cash equivalents as of June 30, 2025: $15 million

The structure of potential non-dilutive funding from licensing partnerships remains an opportunity, though specific amounts for upfront payments are not publicly detailed as of late 2025, aligning with the company's focus on advancing enobosarm through clinical milestones.

Revenue Source Category	Specific Item/Event	Reported/Expected Amount	Timing/Status
Financing Proceeds	October 2025 Public Offering (Gross)	$25.2 million	Closed/Expected October 2025
Financing Proceeds	Potential Warrant Exercise (Gross)	$50.4 million	Contingent on exercise
Asset Sale Proceeds	FC2 Female Condom Business Sale (Gross)	$18 million	Completed late 2024
Asset Sale Proceeds	ENTADFI Upfront Payment (Total)	$20 million	Received through FY2024
Contingent Asset Sale Revenue	ENTADFI Sales Milestones (Maximum)	Up to $80 million	Probability deemed remote as of late 2024
Continuing Operations	Reported Revenue (Q4 2024)	$16.9M	Prior period benchmark

The company is definitely prioritizing the use of these capital proceeds for its drug pipeline, which means the revenue streams are currently weighted toward financing rather than product sales.