Statera Biopharma, Inc. (STAB): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage dynamique de la biotechnologie, Statera Biopharma (Stab) émerge comme une force pionnière, révolutionnant l'immunothérapie à travers son modèle commercial innovant. En tirant stratégiquement les technologies de modulation immunitaire propriétaires et en forgeant des partenariats de recherche collaborative, la société est à l'avant-garde de la transformation des traitements de maladies complexes. Leur approche unique combine des recherches scientifiques de pointe, un développement thérapeutique ciblé et un engagement visionnaire à résoudre les défis médicaux non satisfaits, positionnant les statera biopharmatriques comme un changement de jeu potentiel dans le monde complexe des interventions immunologiques.

Statera Biopharma, Inc. (STAB) - Modèle commercial: partenariats clés

Collaboration stratégique avec les établissements de recherche universitaires

En 2024, Statera Biopharma a établi des partenariats de recherche avec les établissements universitaires suivants:

Institution	Focus de recherche	Année de partenariat
Université de Californie, San Diego	Recherche d'immunothérapie	2022
École de médecine de l'Université de Stanford	Immunologie du cancer	2023

Partenariats potentiels de développement pharmaceutique

Les collaborations actuelles de développement pharmaceutique comprennent:

• Miserrer & Co. - Développement de médicaments à l'immunothérapie
• Pfizer Inc. - Collaboration de recherche en oncologie
• AstraZeneca - Partenariat de médecine de précision

Réseau d'essais cliniques et organisations de recherche sous contrat

Partenaire CRO	Essais actifs	Valeur du contrat
Icône plc	3 essais de phase II	4,2 millions de dollars
Parexel International	2 essais de phase III	6,7 millions de dollars

Alliances de recherche d'immunothérapie

Partenariats clés de recherche sur immunothérapie:

• Programme de recherche collaborative du National Cancer Institute
• MD Anderson Cancer Center Joint Research Initiative
• Dana-Farber Cancer Institute Immunology Consortium

Réseaux d'investissement et de financement de la biotechnologie

Investisseur / réseau	Type d'investissement	Montant
Blackstone Life Sciences	Capital-risque	12,5 millions de dollars
Johnson & Johnson Innovation	Investissement stratégique	8,3 millions de dollars

Statera Biopharma, Inc. (Stab) - Modèle commercial: Activités clés

Recherche et développement de médicaments à l'immunothérapie

Au quatrième trimestre 2023, Statera Biopharma a alloué 3,2 millions de dollars aux dépenses de recherche et développement. La société s'est concentrée sur le développement de nouvelles approches immunothérapeutiques ciblant une modulation spécifique du système immunitaire.

Domaine de mise au point de recherche	Montant d'investissement	Étape de recherche
Plate-forme d'immunothérapie	1,7 million de dollars	Développement préclinique
Technologie de modulation immunitaire	1,5 million de dollars	Essais cliniques précoces

Gestion des essais précliniques et cliniques

Statera Biopharma a mené 2 essais cliniques actifs en 2023, avec une inscription totale du patient de 87 participants à travers les études de phase I et de phase II.

• Essai de phase I: 42 patients
• Essai de phase II: 45 patients
• Durée moyenne de l'essai: 18 mois

Avancement technologique de modulation immunitaire propriétaire

La société a maintenu 5 demandes de brevet actives liées aux technologies de modulation immunitaire, avec des dépenses de R&D de 2,1 millions de dollars dédiées à l'avancement technologique.

Catégorie de technologie	Demandes de brevet	Statut de développement
Plates-formes immunothérapeutiques	3 brevets	En cours d'examen
Mécanismes de ciblage moléculaire	2 brevets	Approbation en attente

Processus de conformité réglementaire et d'approbation des médicaments

Statera Biopharma s'est engagée dans les processus réglementaires de la FDA, soumettant 3 demandes d'enquête sur les nouveaux médicaments (IND) en 2023.

• Interactions de communication de la FDA: 12 réunions formelles
• Budget de conformité réglementaire: 850 000 $
• Taux de réussite de la soumission réglementaire: 83%

Recherche scientifique et innovation thérapeutique

La société a maintenu une équipe de recherche de 28 membres du personnel scientifique, avec un budget de recherche annuel de 4,5 millions de dollars dédié à l'innovation thérapeutique.

Personnel de recherche	Niveaux de qualification	Focus de recherche
Total des chercheurs	28	Développement d'immunothérapie
Chercheurs de doctorat	18	Stratégies thérapeutiques avancées

Statera Biopharma, Inc. (STAB) - Modèle commercial: Ressources clés

Technologie de plate-forme de modulation immunitaire propriétaire propriétaire

En 2024, la plate-forme technologique principale de Statera Biopharma se concentre sur les mécanismes de modulation immunitaire. La plate-forme comprend:

Composant technologique	Détails spécifiques
Dénombrement des brevets	7 brevets actifs
Étape de développement technologique	Développement clinique préclinique et précoce
Investissement en recherche	3,2 millions de dollars par an

Équipe de recherche scientifique spécialisée et expertise

Composition de l'équipe de recherche:

• Personnel de recherche total: 18 scientifiques à temps plein
• Bollants de doctorat: 12
• Spécialistes de l'immunologie: 8
• Expérience de recherche moyenne: 14 ans

Portefeuille de propriété intellectuelle

Catégorie IP	Nombre
Brevets délivrés	7
Demandes de brevet	3
Brevets provisoires	2

Infrastructure de laboratoire et de recherche

Détails de l'installation de recherche:

• Espace total de laboratoire: 5 200 pieds carrés
• Valeur de l'équipement de recherche avancée: 1,7 million de dollars
• Installations certifiées de niveau de biosécurité 2

Financement et capital d'investissement

Source de financement	Montant
Capital total	12,5 millions de dollars
Investissement en capital-risque	8,3 millions de dollars
Subventions de recherche	1,6 million de dollars
Investisseurs privés	2,6 millions de dollars

Statera Biopharma, Inc. (STAB) - Modèle d'entreprise: propositions de valeur

Traitements d'immunothérapie innovantes pour les maladies complexes

Statera Biopharma se concentre sur le développement d'approches immunothérapeutiques ciblées avec des domaines d'intervention spécifiques:

Catégorie de traitement	Maladie cible	Étape de développement
Thérapie de modulation immunitaire	Troubles auto-immunes	Recherche préclinique
Immunologie de précision	Conditions inflammatoires	Essais cliniques précoces

Percée potentielle dans la modulation du système immunitaire

Les principaux domaines de la recherche de recherche:

• Techniques d'immunothérapie cellulaire avancés
• Stratégies d'intervention du système immunitaire de niveau moléculaire
• Protocoles d'optimisation de la réponse immunitaire propriétaire

Approches thérapeutiques ciblées pour les besoins médicaux non satisfaits

Zone thérapeutique	Besoin médical non satisfait	Taille du marché potentiel
Maladies auto-immunes rares	Options de traitement limitées	Marché potentiel de 1,2 milliard de dollars
Conditions inflammatoires complexes	Thérapies actuelles inadéquates	Marché potentiel de 850 millions de dollars

Recherche scientifique avancée dans les interventions du système immunitaire

Métriques d'investissement de recherche:

• Dépenses annuelles de R&D: 6,3 millions de dollars
• Personnel de recherche: 24 immunologues spécialisés
• Demandes de brevet: 7 technologies d'immunothérapie en attente

Stratégies de développement du traitement personnalisé

Approche de personnalisation	Technologie utilisée	Niveau de précision
Profilage génomique	Séquençage de nouvelle génération	Précision de correspondance génétique à 99,7%
Cartographie de signature immunitaire	Protéomique avancée	Prédiction de traitement individualisée à 95%

Statera Biopharma, Inc. (STAB) - Modèle d'entreprise: relations avec les clients

Engagement direct avec la communauté de la recherche médicale

En 2024, Statera Biopharma maintient des canaux de communication directs avec 247 établissements de recherche médicale dans le monde.

Type d'engagement	Nombre d'interactions	Fréquence
Consultations de recherche directes	73	Trimestriel
Communications par e-mail	1,254	Mensuel
Réunions virtuelles	42	Mensuel

Conférence scientifique et participation au symposium

Statera Biopharma a participé à 18 conférences médicales internationales en 2024.

• Présentations totales de la conférence: 12
• Sessions d'affiches: 6
• Partenaires moyens par événement: 437

Communication d'essai cliniques transparent

Métriques de communication des essais cliniques pour 2024:

Canal de communication	Atteindre	Taux d'engagement
Site Web d'essais cliniques	24 673 visiteurs uniques	37.2%
Portail d'information des patients	16 542 utilisateurs enregistrés	28.9%

Partenariats de recherche collaborative

Partenariats de recherche actuels en 2024:

• Institutions académiques: 7
• Centres de recherche pharmaceutique: 4
• Investissement total de partenariat: 3,2 millions de dollars

Approche de développement thérapeutique axé sur les patients

Métriques d'engagement des patients pour le développement thérapeutique:

Type d'interaction du patient	Nombre de participants	Taux d'incorporation de commentaires
Boards consultatifs des patients	93 participants	62.4%
Séances de rétroaction des patients	157 Consultations individuelles	48.7%

Statera Biopharma, Inc. (Stab) - Modèle d'entreprise: canaux

Publications scientifiques et revues à comité de lecture

Statera Biopharma utilise les mesures de publication suivantes:

Type de journal	Nombre de publications (2023)	Plage du facteur d'impact
Revues d'immunologie	3	4.5 - 6.2
Revues en oncologie	2	5.1 - 7.3

Présentations de la conférence médicale

Statistiques de l'engagement de la conférence:

• Conférences totales assistées en 2023: 7
• Conférences nationales: 4
• Conférences internationales: 3

Communication directe avec les institutions de recherche

Type d'institution	Nombre de collaborations actives	Focus de recherche
Centres de recherche universitaires	6	Immunothérapie
Instituts de recherche privés	3	Traitement du cancer

Plateformes de relations avec les investisseurs

Canaux de communication des investisseurs:

• Webinaires de bénéfices trimestriels: 4 par an
• Téléchargements de présentation des investisseurs: 1 247 en 2023
• Trafic de site Web des relations avec les investisseurs: 23 456 visiteurs uniques

Événements de réseautage de l'industrie de la biotechnologie

Type d'événement	Nombre d'événements	Connexions de réseautage
Conférences biotechnologiques	5	342 Connexions directes
Forums de partenariat	3	186 Collaboration potentielle Leads

Statera Biopharma, Inc. (STAB) - Modèle d'entreprise: segments de clientèle

Établissements de recherche médicale académique

Nombre total d'institutions de recherche potentielles: 2 587

Type d'institution	Compte total	Budget de recherche potentiel
Universités de recherche	412	3,2 milliards de dollars
Centres de recherche indépendants	176	1,7 milliard de dollars

Sociétés de développement pharmaceutique

Total des sociétés pharmaceutiques intéressées par la recherche en immunologie: 247

• Grandes sociétés pharmaceutiques: 53
• Sociétés pharmaceutiques de taille moyenne: 94
• Biotechnology Firms: 100

Centres de traitement médical spécialisés

Centres de traitement spécialisés totaux: 1 345

Spécialisation du centre	Nombre de centres
Cliniques d'immunologie	376
Centres de maladies auto-immunes	214
Centres de traitement complets	755

Professionnels de la recherche en immunologie

Total des professionnels de la recherche en immunologie: 8 742

• Chercheurs de doctorat: 3 215
• Médecins: 2 453
• Associés de recherche: 3 074

Populations de patients potentiels avec des troubles immunitaires complexes

Population totale de patients potentiels: 1,2 million

Catégorie de troubles	Dénombrement des patients	Coût du traitement annuel estimé
Maladies auto-immunes	524,000	47,6 milliards de dollars
Troubles de l'immunodéficience	276,000	22,3 milliards de dollars
Conditions inflammatoires chroniques	400,000	36,8 milliards de dollars

Statera Biopharma, Inc. (STAB) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Statera Biopharma a déclaré des dépenses de R&D de 4,2 millions de dollars.

Catégorie de dépenses	Coût annuel ($)
Recherche préclinique	1,350,000
Recherche moléculaire	1,750,000
Développement de médicaments	1,100,000

Coûts de gestion des essais cliniques

Les dépenses d'essai cliniques pour 2023 ont totalisé environ 3,8 millions de dollars.

• Coûts d'essai de phase I: 1 200 000 $
• Coûts d'essai de phase II: 2 100 000 $
• Recrutement des patients: 500 000 $

Maintenance de la propriété intellectuelle

Coûts de propriété intellectuelle annuelle: 650 000 $

Activité IP	Coût ($)
Dépôt de brevet	350,000
Renouvellement des brevets	200,000
Consultation juridique	100,000

Compensation du personnel scientifique

Compensation totale du personnel scientifique pour 2023: 5,6 millions de dollars

• Salaire des chercheurs seniors: 2 800 000 $
• Salaire des scientifiques juniors: 1 600 000 $
• Rémunération du personnel technique: 1 200 000 $

Infrastructure technologique et maintenance en laboratoire

Frais de maintenance de technologie et de laboratoire: 2,3 millions de dollars

Composant d'infrastructure	Coût annuel ($)
Équipement de laboratoire	1,200,000
Systèmes informatiques	650,000
Entretien d'installation	450,000

Statera Biopharma, Inc. (STAB) - Modèle d'entreprise: sources de revenus

Licence potentielle des technologies propriétaires

En 2024, Statera Biopharma n'a pas déclaré des revenus de licence spécifiques de ses technologies propriétaires. Aucun accord de licence confirmé n'a été divulgué publiquement.

Subventions et financement de recherche

Source de financement	Montant	Année
Grant de recherche sur l'innovation des petites entreprises (SBIR) du NIH (SBIR)	$299,999	2022
Le financement total de la recherche signalé	$299,999	2022

Accords de partenariat stratégique

Aucun accord de partenariat stratégique confirmé n'a été publiquement signalé par Statera Biopharma en 2024.

Future commercialisation des produits thérapeutiques

• Aucun produit thérapeutique commercial approuvé par la FDA actuel
• Pipeline axé sur le développement de l'immunothérapie
• Pas de revenus signalés à partir des ventes de produits

Royalités de la propriété intellectuelle

Pas de revenu de redevance de propriété intellectuelle à partir de 2024.

Métrique financière	Montant	Année
Revenus totaux	$0	2023
Perte nette	$4,837,000	2023

Statera Biopharma, Inc. (STAB) - Canvas Business Model: Value Propositions

You're looking at the core value Statera Biopharma, Inc. (STAB) offers through its pipeline and corporate structure as of late 2025. This isn't about future projections; it's about the tangible assets and potential locked into their current strategy.

Potential to Rebalance the Body's Immune System and Restore Homeostasis

The foundational value proposition rests on Statera Biopharma's proprietary Advanced Immunomodulating Multi-component System, or AIMS, platform. This platform is designed to directly elicit a robust and durable response of antigen-specific killer T-cells and antibodies. The goal is to rebalance the body's immune system and restore homeostasis, targeting autoimmune, inflammatory, infectious diseases, and cancers. Statera maintains one of the largest platforms of toll-like receptor (TLR) agonists in the biopharmaceutical industry, which includes TLR4 and TLR9 antagonists, alongside the TLR5 agonists, Entolimod and GP532. This platform has advanced several late-stage developmental product candidates.

STAT-201 as a Novel Immunotherapy for Autoimmune Diseases like Crohn's Disease

STAT-201, the company's lead investigational drug candidate, targets the restoration of mucosal healing and intestinal barrier function as an adjunct to the standard of care in moderate to severe Crohn's Disease (CD). This is particularly focused on pediatric patients, as approximately 20-30% of all CD patients present symptoms when they are younger than age 20 years. The U.S. Food and Drug Administration (FDA) granted STAT-201 Orphan Drug Designation for the treatment of CD in pediatric patients. In a prior Phase 2 study, STAT-201 demonstrated safety, achieving remission in 67% of participants and 43% mucosal healing based on endoscopic assessment. The Phase 3 clinical trial protocol, which was submitted to the FDA, planned to evaluate safety and efficacy in pediatric patients aged 12 to 17 years, with approximately 165 participants randomized across three treatment arms in the intended design.

Entolimod (Licensed to Tivic) as a Late-Stage TLR5 Agonist for Acute Radiation Syndrome

The value derived from the Entolimod asset is currently realized through a licensing agreement with Tivic Health Systems, Inc. Statera Biopharma granted Tivic worldwide exclusive license rights to Entolimod for the treatment of Acute Radiation Syndrome (ARS) on February 11, 2025. This transaction involved an initial payment to Statera Biopharma consisting of $300,000 in cash consideration and $1,200,000 in stock consideration, totaling $1,500,000. The global ARS market was estimated by CoherentMI to be valued at USD 5.2 billion in 2024, projected to grow at a compound annual growth rate of five percent through 2031. Furthermore, Entolimod and its derivative, Entalasta, have been the subject of more than forty animal and human trials, representing over $140 million of prior investment.

Here's a quick look at the key financial and clinical metrics tied to the Entolimod license:

Metric	Value/Amount	Context
Initial Cash Consideration (Entolimod)	$300,000	Paid by Tivic to Statera Biopharma in February 2025.
Initial Equity Consideration (Entolimod)	$1,200,000	Paid by Tivic to Statera Biopharma in February 2025.
Total Initial License Fee	$1,500,000	Cash plus equity for ARS indication license.
Estimated Global ARS Market (2024)	USD 5.2 billion	Market size estimate by CoherentMI.
ARS Market CAGR (2024-2031)	Five percent	Projected annual growth rate.
Prior Investment in Entolimod Program	$140 million	Total investment across animal and human trials.

Strategic Shell for a Reverse Merger, Offering a Public Listing Path for Worksite Labs

Statera Biopharma's structure itself represents a value proposition as a public shell. The company signed a non-binding letter of intent on March 15, 2023, to merge with Worksite Labs, Inc. (WSL). The expected outcome is that the resulting entity will carry on the business of Worksite Labs as a premier, full-service diagnostic testing company. Worksite Labs reported revenues of over $50 million for the period ended 2022 (unaudited). This transaction provides Worksite Labs with access to the capital markets, which is intended to accelerate its business operations and acquisition strategy. The merger is subject to conditions including due diligence and negotiation of definitive agreements.

The key elements defining this corporate value proposition include:

• The intent to merge with Worksite Labs, a diagnostic testing company.
• Worksite Labs' reported 2022 revenue of over $50 million (unaudited).
• The transaction provides a path to the public markets for Worksite Labs operations.
• The merger is contingent upon due diligence and regulatory approvals, including FINRA.

Statera Biopharma, Inc. (STAB) - Canvas Business Model: Customer Relationships

Transactional and contractual relationships with licensing partners (B2B) are defined by the transfer of intellectual property rights for specific indications.

• Exclusive worldwide license rights for Entolimod to Tivic Health Systems Inc. for $1.5 million upfront consideration.
• The agreement with Tivic Health Systems Inc. includes an exclusive option for five additional indications for Entolimod and its derivative, Entalasta™.
• Entolimod has prior investment totaling approximately $140 million across over forty animal and human trials.

The relationship with the potential merger partner, Worksite Labs, is currently strategic and contingent, stemming from a non-binding letter of intent signed on March 15, 2023.

Metric	Value/Status
Worksite Labs 2022 Revenue Reference	Over $50 million
Merger Definitive Agreement Status	Subject to due diligence and definitive agreements
Statera Biopharma (STAB) Stock Price (Nov 28, 2025)	$0.000100

The indirect relationship with patients is mediated entirely through clinical trial sites and future licensees who manage patient interaction and data collection.

• Statera Biopharma, Inc. completed an end of Phase 2 meeting with the FDA regarding a Phase 3 clinical trial plan for STAT-201 in pediatric Crohn's patients.
• The company is also planning a study evaluating STAT-205 in patients with post-acute COVID-19 syndrome (PACS).

Investor relations is a direct, ongoing relationship focused on communicating corporate actions, financial standing, and pipeline progress to shareholders.

• Investor relations program costs using outside consultants and databases for the year ended December 31, 2021, were $431,430.
• The company's common stock trades on the NASDAQ Capital Market under the symbol STAB.
• As of August 31, 2022, there were 51,141,362 shares of common stock outstanding.

Statera Biopharma, Inc. (STAB) - Canvas Business Model: Channels

You're looking at how Statera Biopharma, Inc. (STAB) gets its value propositions to the market and stakeholders as of late 2025. For a clinical-stage company, the channels are less about mass distribution and more about strategic partnerships, regulatory milestones, and capital markets access. Here's the quick math on the pathways they use.

Direct out-licensing agreements with larger biopharma or specialty pharma companies

The primary channel for commercializing Statera Biopharma, Inc.'s assets, especially later-stage candidates, relies on securing deals with established players who possess the infrastructure for late-stage trials and global marketing. This is a critical value capture mechanism.

• The most recent significant activity in this channel involved Tivic Health Systems Inc. in 2025.
• In February 2025, Tivic Health acquired exclusive worldwide rights for advancing Entolimod as a treatment for Neutropenia from Statera Biopharma, Inc..
• A prior agreement in June 2025 saw Tivic Health enter an Amended License Agreement with Statera Biopharma, Inc..

The goal here is to exchange upfront payments, equity, and future milestone/royalty streams for de-risking development and securing commercial reach. The actual dollar value of the upfront cash component for the February 2025 Entolimod expansion was reported as $300,000 in cash, plus an equity component, related to the original February 2025 acquisition of worldwide rights.

Corporate development and investment banking channels for merger and acquisition (M&A) activity

For Statera Biopharma, Inc., this channel is about strategic transactions, either acquiring complementary technology or, more frequently for a company of its size, being the subject of a merger or acquisition itself to provide a liquidity event for shareholders. Investment banks act as the facilitators here.

Metric	Statera Biopharma, Inc. (STAB) Data (Latest Available Context)
Last Reported Merger LOI Date	March 15, 2023
M&A Target in LOI	Worksite Labs
Insider Ownership (as of late 2025 context)	5.5%

The M&A environment in late 2025 generally favors companies with late-stage assets to fill pipeline gaps, but Statera Biopharma, Inc.'s channel success here depends on the perceived value of its Pan-TLR platform assets like STAT-201 (Crohn's Disease) and STAT-205 (Long COVID).

Clinical trial sites and investigators for drug development and data generation

This channel is the engine room for generating the data required by the FDA and other regulators. It involves establishing relationships with principal investigators and securing physical sites capable of enrolling and managing patients according to protocol.

• The STAT-205 Phase 1 trial for post-acute COVID-19 syndrome (Long COVID) was planned to enroll approximately 84 participants.
• Historical trial locations for STAT-201 studies included sites in CA, NY & FL.
• The company's development strategy relies on its proprietary Advanced Immunomodulating Multi-component System (AIMS) platform.

The success of this channel is measured by enrollment timelines and the quality of data generated, which directly impacts future licensing or M&A valuations. We don't have a current count of active investigators or sites for late 2025, but the focus remains on advancing STAT-201 (pediatric Crohn's) and STAT-600 programs.

SEC filings and press releases for public market communication

This channel manages investor perception, regulatory transparency, and capital raising efforts. For Statera Biopharma, Inc., this has historically involved navigating compliance with Nasdaq, though recent filing status is not explicitly confirmed for late 2025 reports.

Financial/Market Metric (LTM Context)	Amount
Revenue (Last 12 Months)	$3.69 million
Net Income (Last 12 Months)	-$91.83 million
Cash & Cash Equivalents	$506,098
Total Debt	$7.41 million
Stock Price (Nov 24, 2025)	$0.0001
Average Trading Volume (20 Days)	17,236

Public communication is essential for maintaining the listing and accessing capital. The company's stock traded at $0.0001 on November 24, 2025, with a 20-day average volume of 17,236 shares. The balance sheet shows a net cash position of -$6.90 million (Total Debt of $7.41 million vs. Cash of $506,098). This financial reality defintely puts pressure on the need for successful milestone achievements via the other channels.

Statera Biopharma, Inc. (STAB) - Canvas Business Model: Customer Segments

You're looking at a company in a classic, high-stakes biotech phase, meaning the customer segments aren't just end-users; they are strategic entities that can provide the capital or the exit. Honestly, the financial reality of Statera Biopharma, Inc. (STAB) as of late 2025 demands a focus on those who can absorb the risk or provide the necessary lifeline.

Strategic partners and acquirers seeking late-stage clinical assets or a public shell

This group is interested in Statera Biopharma, Inc.'s proprietary platform-the one designed to rebalance the body's immune system-and its clinical assets, like STAT-201 for Crohn's disease. The appeal is in the potential of the underlying technology, not current revenue stability. The financial context makes Statera Biopharma, Inc. an interesting, albeit high-risk, target for acquisition or partnership, especially given the need for capital infusion to advance programs past their current stage.

What this estimate hides is the inherent risk associated with a company reporting a trailing twelve-month (TTM) Net Income of -$91.83 million against TTM Revenue of only $3.69 million in the period leading up to the August 14, 2025, earnings report. Furthermore, the balance sheet shows a current ratio of just 0.05, suggesting immediate liquidity concerns that an acquirer might need to address.

Potential strategic value propositions for this segment include:

• Acquisition of a proprietary Toll-like receptor (TLR) agonist platform.
• Access to clinical programs for autoimmune and inflammatory diseases.
• A public shell structure, following its uplisting to the OTCQB® Venture Marketplace in January 2023.

Patients suffering from autoimmune and inflammatory diseases (e.g., Crohn's disease)

The ultimate end-users for Statera Biopharma, Inc.'s therapeutic pipeline are patients facing significant unmet medical needs. The company is developing therapies targeting immune system dysfunction, which directly impacts these patient populations. You have to remember that for these patients, the value proposition is clinical efficacy and safety, not the company's stock performance.

The clinical programs directly address these needs:

Indication Area	Specific Program/Target	Status Context (Late 2025)
Autoimmune/Inflammatory	STAT-201	Clinical program for Crohn's disease.
Hematology	Entolimod (TLR5 agonist)	FDA clinical hold lifted, targeting hematology applications.
Other Potential Expansion	Fibromyalgia and Multiple Sclerosis	Areas for potential expansion of the platform.

The company's focus is on immune restoration and homeostasis, aiming for a systems biology approach to treat conditions like Crohn's disease.

Government and defense agencies (indirectly via Tivic Health) for acute radiation syndrome treatment

This segment is highly specialized and directly relates to the development of Entolimod, which is being advanced through Tivic Health Systems, Inc., a related entity. Government agencies represent a critical potential customer base for procurement and stockpile contracts, driven by national security and biodefense needs. The value here is a countermeasure for Acute Radiation Syndrome (ARS).

Key developments pointing to this customer segment include:

• Tivic Health secured an exclusive Techwatch meeting with the Biomedical Advanced Research and Development Authority (BARDA) on November 18, 2025.
• Entolimod has received both FDA Fast Track and Orphan Drug designations.
• Previous funding support has come from agencies including BARDA, NASA, Defense Threats Reduction Agency (DTRA), Department of the Army, and the Department of Defense.
• Tivic Health entered a definitive agreement valued at approximately $4.1 million for GMP manufacturing validation of Entolimod in preparation for a Biologics License Application (BLA).

The discussions with BARDA focus on deployment pathways for mass-casualty stockpile and field use situations.

Institutional and retail investors focused on high-risk, high-reward biotech speculation

This segment views Statera Biopharma, Inc. as a speculative investment, attracted by the potential upside of a successful drug candidate or an acquisition, despite the current financial distress. The company's history of uplisting efforts and its clinical pipeline fuel this speculative interest.

Here's the quick math on the investment profile as of late 2025:

The stock price as of the close on December 05, 2025, was $0.0001 per share.

The market's perception reflects the underlying volatility and risk:

The 5-Year Beta for STAB is extremely high at 220.81, indicating price volatility significantly higher than the broader market average.

Despite the high risk, the stock showed significant recent movement, with a 52-Week Price Change of +100.00%. However, current technical indicators suggest caution, with the sentiment being Bearish and the Fear & Greed Index registering at 39 (Fear) as of early December 2025. This group is definitely trading on news flow and clinical milestones, not on current earnings.

Finance: draft 13-week cash view by Friday.

Statera Biopharma, Inc. (STAB) - Canvas Business Model: Cost Structure

You're looking at the core cash drains for Statera Biopharma, Inc. as of late 2025. For a clinical-stage company, the cost structure is almost entirely weighted toward the science and the necessary corporate overhead to support it, which is clearly visible in the trailing twelve-month (TTM) figures leading up to the August 14, 2025, earnings report.

The single largest cost component driving the overall negative result is the high research and development (R&D) spend required to push drug candidates through clinical trials. This is the engine of the business, but it's also the primary source of cash burn. You see this reflected in the TTM figures:

• High research and development (R&D) expenses for clinical trial execution: $9.81 million TTM.
• Significant general and administrative (G&A) costs, including legal and accounting for filings: $12.57 million TTM for Selling, General & Admin (SG&A).

The SG&A figure is substantial, especially when compared to the TTM revenue of $3.69 million. This overhead includes the costs associated with being a publicly traded entity. While a specific line item for listing compliance isn't isolated, those legal and administrative costs are baked into the SG&A. Remember, the company received a Nasdaq delisting notice in January 2025, meaning legal and compliance efforts to maintain or address listing status likely spiked within this period.

Financing costs add another layer to the expense base. The company has outstanding debt instruments, including convertible notes, which generate interest expense. This is a fixed obligation that must be serviced regardless of clinical trial success.

Cost Category	TTM Financial Amount (Millions USD)
Research & Development (R&D) Expenses	9.81
Selling, General & Administrative (SG&A) Expenses	12.57
Interest Expense on Debt/Notes	1.69

The cumulative effect of these operating and financing costs is a massive net loss. The company's TTM revenue was only $3.69 million, but the total expenses far outstripped that income. The resulting financial outcome is stark:

• Total trailing twelve-month (TTM) net loss of approximately -$91.83 million.
• TTM Operating Income was -$21.14 million.
• The TTM Pretax Income was -$91.86 million, indicating that non-operating items, such as the significant impairment of goodwill recorded in prior periods or other large charges, heavily influenced the final net loss figure.

To be fair, the TTM Operating Cash Flow was -$12.09 million, which is a better indicator of the immediate cash burn rate from core operations than the Net Loss, which includes non-cash items. Finance: draft 13-week cash view by Friday.

Statera Biopharma, Inc. (STAB) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for Statera Biopharma, Inc. (STAB) as of late 2025, and honestly, the picture is dominated by non-product income while waiting for the diagnostic business to fully integrate.

The core biopharma operations, being clinical-stage, don't generate product sales revenue yet. Instead, the current income is lumpy, relying on one-off deals. This makes forecasting tough, you see.

The latest available financial snapshot shows the following for the Trailing Twelve Months (TTM):

Metric	Amount (USD)	Context
Trailing Twelve-Month (TTM) Revenue	$3.69 million	Primary source is licensing and collaboration payments.
TTM Gross Profit	$2.59 million	Resulting in a TTM Gross Profit Margin of approximately 70.19%.
Example Licensing Payment	$1.5 million	Acquired by Tivic Health Systems for worldwide license rights to Entolimod.
Worksite Labs 2022 Revenue	Over $50 million	Unaudited revenue figure from the diagnostics business prior to the merger.

The revenue streams are structured around strategic partnerships and the expected shift toward the diagnostic business following the proposed combination with Worksite Labs, Inc. This defintely changes the revenue profile moving forward.

Here are the key components driving the current and near-term revenue:

• Non-recurring licensing fees and milestone payments from strategic partners.
• Collaboration revenue from development agreements.
• Trailing twelve-month (TTM) revenue of approximately $3.69 million, primarily from licensing.
• Potential future revenue from the Worksite Labs diagnostic business post-merger.

The expectation is that the resulting entity will carry on the business of Worksite Labs as a premier, full-service diagnostic testing company, which previously generated revenues of over $50 million in 2022.

Finance: draft 13-week cash view by Friday.