Statera Biopharma, Inc. (STAB): Business Model Canvas [Dec-2025 Updated]

You're looking at a company, Statera Biopharma, Inc. (STAB), whose late-2025 business model is definitely less about immediate drug sales and more about corporate maneuvering to survive. Honestly, when you see cash on hand hovering near just \$506,098 while facing a trailing twelve-month net loss of -\$91.83 million, the primary value proposition shifts: it's about being a strategic public shell for the Worksite Labs merger, even as they push STAT-201 forward. This canvas distills exactly how Statera Biopharma is managing that tightrope-balancing crucial clinical work with securing non-dilutive revenue of about \$3.69 million-so you can see the precise assets and risks involved in this high-stakes play below.

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

The Key Partnerships component of the Business Model Canvas for Statera Biopharma, Inc. centers on strategic alliances for asset development, licensing, and operational support, reflecting a shift toward maximizing the value of its immunotherapy platform.

The relationship with Tivic Health Systems, Inc. is a significant licensing agreement for the Toll-like Receptor 5 (TLR5) agonist, Entolimod. Tivic Health acquired worldwide exclusive license rights from Statera Biopharma for Entolimod to treat acute radiation syndrome (ARS). This agreement, initially announced in February 2025, included an initial payment to Statera Biopharma of $1,200,000 in equity consideration and $300,000 cash for the ARS indication. The Entolimod program has been the subject of more than forty animal and human trials, with prior investment totaling $140 million.

Tivic Health exercised its licensing option for a second indication, Neutropenia, on March 28, 2025. Tivic Health also holds an exclusive option to license five additional indications, three of which are specified as Lymphocyte exhaustion, Immunosenescence, and chronic radiation syndrome. In August 2025, Statera Biopharma transferred two Investigational New Drug applications (INDs) to Tivic Health, covering ARS and advanced cancers. The global market for ARS was estimated at USD 5.2 billion in 2024, with a projected Compound Annual Growth Rate (CAGR) of five percent through 2031, while the global Neutropenia market is estimated to exceed $20 billion by 2029.

Statera Biopharma signed a non-binding letter of intent on March 15, 2023, to merge with the diagnostics company Worksite Labs, Inc. The entities emerging from the potential transaction were expected to continue the business of Worksite Labs, which generated revenues of over $50 million in 2022. This proposed transaction was subject to conditions including due diligence and the negotiation of definitive agreements.

An earlier strategic agreement was established with Immune Therapeutics Inc. concerning Low Dose Naltrexone (LDN). Under the anticipated terms of the April 2022 agreement, Statera Biopharma was set to sell its rights to any LDN product to Immune Therapeutics. Statera Biopharma was slated to receive an initial $2 million upfront payment and 5% of Immune Therapeutics' issued and outstanding stock. This transaction had the potential to generate over $400 million in non-dilutive payments through milestones, royalties, and approvals across indications like Crohn's disease, COVID-19, asthma, multiple sclerosis, HIV, and chemotherapy-related conditions.

The need for external Clinical Research Organizations (CROs) is underscored by the broader industry environment. The global clinical trials services market size was valued at USD 76.70 billion in 2024. In the second quarter of 2025, leading CROs reported significant revenues, with Thermo Fisher Scientific (PPD Division) at $6 billion and IQVIA at $4.02 billion. The North American pharmaceutical CRO market is projected to reach $13.73 billion by 2030, growing at a CAGR of 5.6% between 2025 and 2030.

Statera Biopharma also has a partnership framework with Lay Sciences Inc., announced in May 2022, for an option to license manufacturing rights to certain Lay Sciences IgY products. This involves an option for Statera Biopharma to license products for respiratory & gastrointestinal disorders. Lay Sciences was to receive an upfront payment comprised of equity and cash, with potential for royalties and milestones related to development in gastrointestinal and upper respiratory indications.

Key Partnership Financial and Status Overview:

Statera Biopharma, Inc. relies on these external entities for specific development stages and potential revenue streams:

• Tivic Health Systems, Inc. for late-stage clinical advancement and commercialization of Entolimod.
• Worksite Labs, Inc. for a potential business combination to enhance diagnostic capabilities.
• Immune Therapeutics Inc. for realizing value from the LDN asset portfolio.
• Clinical research organizations (CROs) for managing the execution of ongoing clinical trials.
• Lay Sciences Inc. for manufacturing rights to IgY products for respiratory & gastrointestinal disorders.

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

You're managing a company where the primary focus is on executing complex transactions and advancing a lead asset, so every dollar spent on overhead matters immensely. Here's the quick math on the key activities Statera Biopharma, Inc. (STAB) is driving right now, based on the latest figures we have access to.

Managing the complex due diligence and negotiation for the Worksite Labs merger.

The due diligence and negotiation process centers around integrating the Worksite Labs business, which reported revenues of over $50 million for the period ended 2022. The transaction, initially announced via a non-binding letter of intent in March 2023, requires meticulous management to ensure the resulting entity aligns with Statera Biopharma, Inc. (STAB)'s strategic goals for patient diagnosis and treatment identification.

Maintaining and protecting the core intellectual property (IP) portfolio.

Protecting the AIMS platform and STAT-200 series assets is paramount. While the exact number of active patents as of late 2025 isn't public, past activities show a reliance on licensing revenue streams tied to IP rights.

Advancing the clinical development of STAT-201 for Crohn's disease.

STAT-201, targeting pediatric Crohn's disease, has secured Orphan Drug Designation from the U.S. Food and Drug Administration (FDA). The clinical plan involved completing an end-of-Phase 2 meeting with the FDA regarding a Phase 3 trial, which Statera Biopharma, Inc. (STAB) planned to initiate in 2022. The focus remains on restoration of mucosal healing and intestinal barrier function as an adjunct to the standard of care.

Securing non-dilutive financing through asset licensing and collaboration payments.

Non-dilutive capital generation is a critical activity to extend the cash runway. A concrete example of this mechanism is the February 2023 transaction where Tivic Health Systems, Inc. acquired exclusive worldwide license rights to the TLR5 agonist Entolimod from Statera Biopharma, Inc. (STAB) for $1.5 million. This sets the precedent for value extraction from pipeline assets.

Ensuring minimal general and administrative (G&A) overhead to preserve capital.

With a market valuation under pressure, controlling burn rate is a daily focus. The stock price as of 2025-11-14 was $0.000100 per share, reflecting the imperative to keep fixed costs low. The market capitalization as of February 2023 stood at $1.72 million, underscoring the need for lean operations.

Here are the key financial and statistical anchors related to these activities:

The clinical development plan for STAT-201 specifically targets pediatric patients with Crohn's disease.

• FDA granted STAT-201 Orphan Drug Designation.
• Phase 3 trial planning followed an end-of-Phase 2 meeting.
• The drug focuses on mucosal healing and intestinal barrier function.

Statera Biopharma, Inc. (STAB) is also advancing other candidates through its AIMS platform, including STAT-400 and STAT-600 programs.

Finance: draft 13-week cash view by Friday.

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

You're looking at the core assets Statera Biopharma, Inc. relies on to drive its pipeline forward, which is a mix of proprietary science and lean operational finance. Honestly, for a clinical-stage company, the IP and the cash runway are everything right now.

The foundation is the proprietary immune restoration and homeostasis platform technology, known as AIMS (ADVANCED IMMUNOMODULATING MULTI-COMPONENT SYSTEM). This platform is designed to engage multiple components of the immune system to resolve disease and elicit homeostasis, moving beyond single-target approaches. The technology is based on leveraging complex pleiotropic beneficial effects, similar to natural analogs, to activate essential immune defenses against autoimmune, inflammatory, infectious diseases, and cancers.

Intellectual property centers around this platform and its resulting candidates. For the lead candidate, STAT-201, which targets mucosal healing in pediatric Crohn's disease, Statera Biopharma has secured Orphan Drug Designation from the U.S. Food and Drug Administration (FDA). The company completed a productive end of Phase 2 meeting with the FDA regarding the clinical development plan for a Phase 3 trial for STAT-201 in pediatric Crohn's patients.

Financially, the immediate resource is the capital available to fund ongoing operations and development milestones. As of late 2025, the cash on hand is approximately $506,098.

The operational structure is lean, reflecting a focus on outsourcing non-core functions. The team size is reported at 22 total employees, primarily specialized in clinical and corporate development functions.

Statera Biopharma also maintains existing licensing agreements that provide non-product revenue streams, which are critical for supplementing operational cash. For context on this revenue type, in the third quarter of 2021, the company reported revenues of $236,000, all derived from research services provided by its subsidiary, ImQuest, to its customers.

Here's a quick look at the tangible and intangible assets supporting the business:

The specialized resources can be further broken down by their focus areas:

• Proprietary Platform: Immune restoration and homeostasis science.
• Intellectual Property: Patents and filings covering STAT-201 and others.
• Financial Runway: Cash balance supporting near-term milestones.
• Team Expertise: Focus on clinical trial execution and corporate strategy.
• External Funding: Revenue from existing research and development alliances.

To be fair, the reliance on a small team means that any key personnel departure presents a defintely higher risk to execution timelines.

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:

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.

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.

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.

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:

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.

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):

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.