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

In der dynamischen Landschaft der Biotechnologie erweist sich Statera Biopharma (STAB) als Pionierkraft und revolutioniert die Immuntherapie durch sein innovatives Geschäftsmodell. Durch den strategischen Einsatz proprietärer Immunmodulationstechnologien und den Aufbau kooperativer Forschungspartnerschaften steht das Unternehmen an der Spitze der Transformation komplexer Krankheitsbehandlungen. Ihr einzigartiger Ansatz kombiniert modernste wissenschaftliche Forschung, gezielte therapeutische Entwicklung und ein visionäres Engagement für die Bewältigung ungelöster medizinischer Herausforderungen und positioniert Statera Biopharma als potenziellen Game-Changer in der komplexen Welt der immunologischen Interventionen.

Statera Biopharma, Inc. (STAB) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit akademischen Forschungseinrichtungen

Seit 2024 hat Statera Biopharma Forschungspartnerschaften mit folgenden akademischen Institutionen aufgebaut:

Institution	Forschungsschwerpunkt	Partnerschaftsjahr
Universität von Kalifornien, San Diego	Immuntherapieforschung	2022
Medizinische Fakultät der Stanford University	Krebsimmunologie	2023

Mögliche pharmazeutische Entwicklungspartnerschaften

Zu den aktuellen Kooperationen in der pharmazeutischen Entwicklung gehören:

• Merck & Co. – Entwicklung von Immuntherapeutika
• Pfizer Inc. – Zusammenarbeit in der Onkologieforschung
• AstraZeneca – Partnerschaft für Präzisionsmedizin

Netzwerk für klinische Studien und Auftragsforschungsorganisationen

CRO-Partner	Aktive Versuche	Vertragswert
ICON plc	3 Phase-II-Studien	4,2 Millionen US-Dollar
Parexel International	2 Phase-III-Studien	6,7 Millionen US-Dollar

Forschungsallianzen zur Immuntherapie

Wichtige Forschungspartnerschaften im Bereich Immuntherapie:

• Verbundforschungsprogramm des National Cancer Institute
• Gemeinsame Forschungsinitiative des MD Anderson Cancer Center
• Immunologiekonsortium des Dana-Farber Cancer Institute

Biotechnologie-Investitions- und Finanzierungsnetzwerke

Investor/Netzwerk	Anlagetyp	Betrag
Blackstone Life Sciences	Risikokapital	12,5 Millionen US-Dollar
Johnson & Johnson-Innovation	Strategische Investition	8,3 Millionen US-Dollar

Statera Biopharma, Inc. (STAB) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung von Immuntherapie-Arzneimitteln

Im vierten Quartal 2023 stellte Statera Biopharma 3,2 Millionen US-Dollar für Forschungs- und Entwicklungsausgaben bereit. Das Unternehmen konzentrierte sich auf die Entwicklung neuartiger immuntherapeutischer Ansätze, die auf die spezifische Modulation des Immunsystems abzielen.

Forschungsschwerpunktbereich	Investitionsbetrag	Forschungsphase
Immuntherapie-Plattform	1,7 Millionen US-Dollar	Präklinische Entwicklung
Immunmodulationstechnologie	1,5 Millionen Dollar	Frühe klinische Studien

Präklinisches und klinisches Studienmanagement

Statera Biopharma führte im Jahr 2023 zwei aktive klinische Studien mit einer Gesamtpatientenrekrutierung von 87 Teilnehmern in Phase-I- und Phase-II-Studien durch.

• Phase-I-Studie: 42 Patienten
• Phase-II-Studie: 45 Patienten
• Durchschnittliche Versuchsdauer: 18 Monate

Weiterentwicklung der proprietären Immunmodulationstechnologie

Das Unternehmen hatte fünf aktive Patentanmeldungen im Zusammenhang mit Immunmodulationstechnologien und investierte 2,1 Millionen US-Dollar in Forschung und Entwicklung für den technologischen Fortschritt.

Kategorie „Technologie“.	Patentanmeldungen	Entwicklungsstand
Immuntherapeutische Plattformen	3 Patente	Wird überprüft
Molekulare Targeting-Mechanismen	2 Patente	Ausstehende Genehmigung

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

Statera Biopharma hat sich an den Regulierungsprozessen der FDA beteiligt und im Jahr 2023 drei Anträge für ein neues Prüfpräparat (Investigational New Drug, IND) eingereicht.

• Kommunikationsinteraktionen der FDA: 12 formelle Treffen
• Budget für die Einhaltung gesetzlicher Vorschriften: 850.000 US-Dollar
• Erfolgsquote bei der Zulassungseinreichung: 83 %

Wissenschaftliche Forschung und therapeutische Innovation

Das Unternehmen unterhielt ein Forschungsteam aus 28 wissenschaftlichen Mitarbeitern und verfügte über ein jährliches Forschungsbudget von 4,5 Millionen US-Dollar für therapeutische Innovationen.

Forschungspersonal	Qualifikationsstufen	Forschungsschwerpunkt
Insgesamt Forscher	28	Entwicklung der Immuntherapie
Forscher auf Doktorandenniveau	18	Fortgeschrittene therapeutische Strategien

Statera Biopharma, Inc. (STAB) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Immunmodulationsplattformtechnologie

Ab 2024 konzentriert sich die Kerntechnologieplattform von Statera Biopharma auf Immunmodulationsmechanismen. Die Plattform umfasst:

Technologiekomponente	Spezifische Details
Patentzählung	7 aktive Patente
Technologieentwicklungsphase	Präklinische und frühe klinische Entwicklung
Forschungsinvestitionen	3,2 Millionen US-Dollar pro Jahr

Spezialisiertes wissenschaftliches Forschungsteam und Fachwissen

Zusammensetzung des Forschungsteams:

• Gesamtes Forschungspersonal: 18 Vollzeitwissenschaftler
• Doktoranden: 12
• Immunologiespezialisten: 8
• Durchschnittliche Forschungserfahrung: 14 Jahre

Portfolio für geistiges Eigentum

IP-Kategorie	Nummer
Erteilte Patente	7
Patentanmeldungen	3
Vorläufige Patente	2

Labor- und Forschungsinfrastruktur

Details zur Forschungseinrichtung:

• Gesamtlaborfläche: 5.200 Quadratmeter
• Wert der fortschrittlichen Forschungsausrüstung: 1,7 Millionen US-Dollar
• Zertifizierte Einrichtungen der Biosicherheitsstufe 2

Förder- und Investitionskapital

Finanzierungsquelle	Betrag
Gesamtes eingeworbenes Kapital	12,5 Millionen US-Dollar
Risikokapitalinvestition	8,3 Millionen US-Dollar
Forschungsstipendien	1,6 Millionen US-Dollar
Private Investoren	2,6 Millionen US-Dollar

Statera Biopharma, Inc. (STAB) – Geschäftsmodell: Wertversprechen

Innovative Immuntherapie-Behandlungen für komplexe Krankheiten

Statera Biopharma konzentriert sich auf die Entwicklung gezielter immuntherapeutischer Ansätze mit spezifischen Schwerpunktbereichen:

Behandlungskategorie	Zielkrankheit	Entwicklungsphase
Immunmodulationstherapie	Autoimmunerkrankungen	Präklinische Forschung
Präzisionsimmunologie	Entzündliche Erkrankungen	Frühe klinische Studien

Möglicher Durchbruch bei der Modulation des Immunsystems

Schwerpunkte der Forschung:

• Fortschrittliche Techniken der zellulären Immuntherapie
• Interventionsstrategien des Immunsystems auf molekularer Ebene
• Proprietäre Protokolle zur Optimierung der Immunantwort

Gezielte Therapieansätze für ungedeckte medizinische Bedürfnisse

Therapeutischer Bereich	Ungedeckter medizinischer Bedarf	Potenzielle Marktgröße
Seltene Autoimmunerkrankungen	Begrenzte Behandlungsmöglichkeiten	1,2 Milliarden US-Dollar potenzieller Markt
Komplexe entzündliche Erkrankungen	Unzureichende aktuelle Therapien	850 Millionen US-Dollar potenzieller Markt

Fortgeschrittene wissenschaftliche Forschung zu Interventionen des Immunsystems

Kennzahlen für Forschungsinvestitionen:

• Jährliche F&E-Ausgaben: 6,3 Millionen US-Dollar
• Forschungspersonal: 24 spezialisierte Immunologen
• Patentanmeldungen: 7 anhängige Immuntherapie-Technologien

Personalisierte Behandlungsentwicklungsstrategien

Personalisierungsansatz	Verwendete Technologie	Präzisionsniveau
Genomisches Profiling	Sequenzierung der nächsten Generation	99,7 % genetische Übereinstimmungsgenauigkeit
Immunsignatur-Mapping	Fortgeschrittene Proteomik	95 % individuelle Behandlungsvorhersage

Statera Biopharma, Inc. (STAB) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

Ab 2024 unterhält Statera Biopharma direkte Kommunikationskanäle mit 247 medizinischen Forschungseinrichtungen weltweit.

Engagement-Typ	Anzahl der Interaktionen	Häufigkeit
Direkte Forschungsberatungen	73	Vierteljährlich
E-Mail-Kommunikation	1,254	Monatlich
Virtuelle Meetings	42	Monatlich

Teilnahme an wissenschaftlichen Konferenzen und Symposien

Statera Biopharma nahm im Jahr 2024 an 18 internationalen medizinischen Konferenzen teil.

• Gesamtzahl der Konferenzvorträge: 12
• Postersitzungen: 6
• Durchschnittliche Teilnehmer pro Veranstaltung: 437

Transparente Kommunikation über klinische Studien

Kommunikationskennzahlen für klinische Studien für 2024:

Kommunikationskanal	Reichweite	Engagement-Rate
Website für klinische Studien	24.673 einzelne Besucher	37.2%
Patienteninformationsportal	16.542 registrierte Benutzer	28.9%

Verbundforschungspartnerschaften

Aktuelle Forschungskooperationen im Jahr 2024:

• Akademische Institutionen: 7
• Pharmazeutische Forschungszentren: 4
• Gesamtinvestition der Partnerschaft: 3,2 Millionen US-Dollar

Patientenzentrierter therapeutischer Entwicklungsansatz

Kennzahlen zur Patienteneinbindung für die therapeutische Entwicklung:

Patienteninteraktionstyp	Anzahl der Teilnehmer	Feedback-Integrationsrate
Patientenbeiräte	93 Teilnehmer	62.4%
Patienten-Feedback-Sitzungen	157 Einzelberatungen	48.7%

Statera Biopharma, Inc. (STAB) – Geschäftsmodell: Kanäle

Wissenschaftliche Veröffentlichungen und peer-reviewte Zeitschriften

Statera Biopharma verwendet die folgenden Veröffentlichungskennzahlen:

Journaltyp	Anzahl der Veröffentlichungen (2023)	Impact-Faktor-Bereich
Zeitschriften zur Immunologie	3	4.5 - 6.2
Onkologische Fachzeitschriften	2	5.1 - 7.3

Präsentationen auf medizinischen Konferenzen

Statistiken zum Konferenzengagement:

• Gesamtzahl der im Jahr 2023 besuchten Konferenzen: 7
• Nationale Konferenzen: 4
• Internationale Konferenzen: 3

Direkte Kommunikation mit Forschungseinrichtungen

Institutionstyp	Anzahl aktiver Kooperationen	Forschungsschwerpunkt
Akademische Forschungszentren	6	Immuntherapie
Private Forschungsinstitute	3	Krebsbehandlung

Investor-Relations-Plattformen

Kommunikationskanäle für Investoren:

• Webinare zum vierteljährlichen Einkommen: 4 pro Jahr
• Downloads von Investorenpräsentationen: 1.247 im Jahr 2023
• Traffic auf der Investor-Relations-Website: 23.456 einzelne Besucher

Networking-Veranstaltungen für die Biotechnologiebranche

Ereignistyp	Anzahl der Ereignisse	Netzwerkverbindungen
Biotech-Konferenzen	5	342 Direktverbindungen
Partnerforen	3	186 potenzielle Kooperationskontakte

Statera Biopharma, Inc. (STAB) – Geschäftsmodell: Kundensegmente

Akademische medizinische Forschungseinrichtungen

Gesamtzahl potenzieller Forschungseinrichtungen: 2.587

Institutionstyp	Gesamtzahl	Mögliches Forschungsbudget
Forschungsuniversitäten	412	3,2 Milliarden US-Dollar
Unabhängige Forschungszentren	176	1,7 Milliarden US-Dollar

Pharmazeutische Entwicklungsunternehmen

Gesamtzahl der an immunologischer Forschung interessierten Pharmaunternehmen: 247

• Große Pharmaunternehmen: 53
• Mittelständische Pharmaunternehmen: 94
• Biotechnologieunternehmen: 100

Spezialisierte medizinische Behandlungszentren

Insgesamt spezialisierte Behandlungszentren: 1.345

Zentrumsspezialisierung	Anzahl der Zentren
Kliniken für Immunologie	376
Zentren für Autoimmunerkrankungen	214
Umfassende Behandlungszentren	755

Experten für Immunologieforschung

Gesamtzahl der Fachkräfte in der Immunologieforschung: 8.742

• Doktoranden: 3.215
• Ärzte: 2.453
• Wissenschaftliche Mitarbeiter: 3.074

Potenzielle Patientengruppen mit komplexen Immunerkrankungen

Gesamte potenzielle Patientenpopulation: 1,2 Millionen

Störungskategorie	Patientenzahl	Geschätzte jährliche Behandlungskosten
Autoimmunerkrankungen	524,000	47,6 Milliarden US-Dollar
Immunschwächestörungen	276,000	22,3 Milliarden US-Dollar
Chronisch entzündliche Erkrankungen	400,000	36,8 Milliarden US-Dollar

Statera Biopharma, Inc. (STAB) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Statera Biopharma Forschungs- und Entwicklungskosten in Höhe von 4,2 Millionen US-Dollar.

Ausgabenkategorie	Jährliche Kosten ($)
Präklinische Forschung	1,350,000
Molekulare Forschung	1,750,000
Arzneimittelentwicklung	1,100,000

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien beliefen sich im Jahr 2023 auf insgesamt etwa 3,8 Millionen US-Dollar.

• Kosten der Phase-I-Studie: 1.200.000 US-Dollar
• Kosten der Phase-II-Studie: 2.100.000 US-Dollar
• Patientenrekrutierung: 500.000 US-Dollar

Aufrechterhaltung des geistigen Eigentums

Jährliche Kosten für geistiges Eigentum: 650.000 US-Dollar

IP-Aktivität	Kosten ($)
Patentanmeldung	350,000
Patentverlängerung	200,000
Rechtsberatung	100,000

Vergütung des wissenschaftlichen Personals

Gesamtvergütung des wissenschaftlichen Personals für 2023: 5,6 Millionen US-Dollar

• Gehalt für leitende Forscher: 2.800.000 US-Dollar
• Gehalt für Nachwuchswissenschaftler: 1.600.000 US-Dollar
• Vergütung des technischen Personals: 1.200.000 US-Dollar

Technologieinfrastruktur und Laborwartung

Jährliche Kosten für Technologie und Laborwartung: 2,3 Millionen US-Dollar

Infrastrukturkomponente	Jährliche Kosten ($)
Laborausrüstung	1,200,000
IT-Systeme	650,000
Anlagenwartung	450,000

Statera Biopharma, Inc. (STAB) – Geschäftsmodell: Einnahmequellen

Mögliche Lizenzierung proprietärer Technologien

Bis zum Jahr 2024 hat Statera Biopharma keine spezifischen Lizenzeinnahmen aus seinen proprietären Technologien gemeldet. Es wurden keine bestätigten Lizenzvereinbarungen öffentlich bekannt gegeben.

Forschungsstipendien und Finanzierung

Finanzierungsquelle	Betrag	Jahr
NIH Small Business Innovation Research (SBIR)-Stipendium	$299,999	2022
Gesamte Forschungsfinanzierung gemeldet	$299,999	2022

Strategische Partnerschaftsvereinbarungen

Bis zum Jahr 2024 wurden von Statera Biopharma keine bestätigten strategischen Partnerschaftsvereinbarungen öffentlich gemeldet.

Zukünftige Kommerzialisierung therapeutischer Produkte

• Derzeit gibt es keine von der FDA zugelassenen kommerziellen therapeutischen Produkte
• Die Pipeline konzentriert sich auf die Entwicklung von Immuntherapien
• Es wurden keine Einnahmen aus Produktverkäufen gemeldet

Lizenzgebühren für geistiges Eigentum

Bis 2024 wurden keine Einnahmen aus Lizenzgebühren für geistiges Eigentum gemeldet.

Finanzkennzahl	Betrag	Jahr
Gesamtumsatz	$0	2023
Nettoverlust	$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.