Statera Biopharma, Inc. (STAB): History, Ownership, Mission, How It Works & Makes Money

When you look at a clinical-stage biopharma like Statera Biopharma, Inc. (STAB), how do you assess the value of a company whose mission is restoring immune health? This company, which develops novel immunotherapies using its Advanced Immunomodulating Multi-Component System (AIMS) platform, is currently valued at a market capitalization of roughly $7.26 million, a figure that starkly contrasts with its trailing twelve-month (TTM) net loss of approximately $91.83 million. The story of Statera Biopharma is a classic biotech challenge: a small team of 46 employees is chasing multi-billion dollar markets like Crohn's disease and hematology with candidates like Entolimod, but its TTM revenue is just $3.69 million, so you need to understand exactly how their pipeline is structured to generate future cash flow.

Statera Biopharma, Inc. (STAB) History

Statera Biopharma, Inc. is a clinical-stage biopharmaceutical company with a complex, multi-stage history. Its current form is the result of a significant merger, but its roots trace back over two decades to a focus on biodefense and oncology. The company's trajectory has been marked by ambitious drug development programs, key government contracts, and recent, dramatic shifts in corporate strategy, including the divestiture of its most advanced asset and an attempted merger with a diagnostics company.

Given Company's Founding Timeline

Year established

The company was originally established in 2003 as Cleveland BioLabs, Inc..

Original location

Cleveland, Ohio, in partnership with the Cleveland Clinic.

Founding team members

The original founding team included Andrei V. Gudkov and Yakov Kogan. Mr. Kogan later served as CEO during the company's evolution.

Initial capital/funding

The initial capital came from its founding in partnership with the Cleveland Clinic. Over its history, the precursor company, Cleveland BioLabs, raised substantial capital, including a large Post IPO round of $30 million in March 2007. By March 31, 2021, the company had raised a total of $160.6 million in net equity capital.

Given Company's Evolution Milestones

Given Company's Transformative Moments

The company's history is defintely a story of reinvention, driven by the need to find a sustainable path after years of clinical-stage losses. The two most transformative moments stand out.

• The 2021 Merger and Rebranding: The combination of Cleveland BioLabs and Cytocom, Inc. to form Statera Biopharma was a full reset. It shifted the primary focus from radiation countermeasures and niche oncology to a broader platform of Toll-like Receptor (TLR) agonists, which are compounds designed to rebalance the body's immune system (homeostasis). This move was an attempt to create a more diversified and commercially viable pipeline.
• The 2025 Entolimod Divestiture: Selling the rights to Entolimod, their flagship Phase III drug, to Tivic Health for $1.5 million was a clear signal of financial strain and a strategic decision to monetize a key asset. This move, happening in 2025, essentially cleared the deck for the company to pursue a new direction, notably the proposed merger with Worksite Labs, a diagnostics company that reported over $50 million in revenue in 2022.

For the 2025 fiscal year, the financial reality is stark: the company had Last Twelve Months (LTM) revenue of only $3.69 million against a net loss of -$91.83 million. This massive loss and a market capitalization of just $7,258 as of November 2025 underscore the urgency of the Worksite Labs merger, which, to be fair, is still a non-binding Letter of Intent. The company is currently trading on the OTC Pink Sheets, with a stock price of $0.0001 as of November 21, 2025. You can find more details on the strategic direction in the Mission Statement, Vision, & Core Values of Statera Biopharma, Inc. (STAB).

Statera Biopharma, Inc. (STAB) Ownership Structure

The ownership structure of Statera Biopharma, Inc. is highly fragmented and dominated by retail investors, a common characteristic for companies trading on the Over-The-Counter Pink Sheets (OTCPK) market, especially those in financial distress.

As of November 2025, the company's tiny market capitalization of approximately $7,258.00 reflects its precarious financial position, with virtually no institutional investment interest remaining. The decision-making power rests largely with the remaining strategic holders and the collective, but often uncoordinated, general public.

Given Company's Current Status

Statera Biopharma, Inc. (STAB) is a publicly traded, clinical-stage biopharmaceutical company, but its stock trades on the OTCPK (Over-The-Counter Pink Sheets) Expert Market, not a major exchange like NASDAQ or NYSE. This is a crucial detail for investors, as it signals significant financial and regulatory risk, including a history of filing delinquencies with the SEC.

The company's financial health is severely challenged, reporting total revenue of only $3.69 million against a staggering net loss of -$91.83 million over the last twelve months ending in August 2025. This massive loss-to-revenue ratio shows the capital burn associated with a clinical-stage biotech that has sold off key assets, like the exclusive worldwide rights to its Phase III asset, Entolimod, to Tivic Health in February 2025. You can dig deeper into the company's financial metrics in Breaking Down Statera Biopharma, Inc. (STAB) Financial Health: Key Insights for Investors.

Given Company's Ownership Breakdown

The ownership breakdown reflects the company's distressed status, with institutional investors having completely exited the stock. This leaves the float largely in the hands of individual investors and a few remaining strategic or insider holders who may have acquired shares at much higher valuations or through debt-to-equity conversions.

Here's the quick math: with institutional ownership at a clear zero, the remaining 100% is split between the people running the company and the retail investors. That's a lot of small-time investors holding the bag.

Given Company's Leadership

The leadership structure of Statera Biopharma is difficult to confirm definitively in its current state, as public records are not consistently updated following the delisting and financial turmoil. The most recently named executive is Michael K. Handley, who has served as the President and Chief Executive Officer.

The Board of Directors, which provides governance and oversight, is considered experienced with an average tenure of 3.4 years. Still, the lack of a clear, recently confirmed executive team is a major red flag for corporate governance.

• President & CEO: Michael K. Handley, MBA (Note: Some 2025 data suggests the CEO position is vacant or unconfirmed, highlighting the company's instability).
• Board of Directors: Includes members like Satish Chandran, Ph.D., who joined in 2022 and has a background in drug, biologicals, and medical device development.
• Employee Count: The company operates with a minimal team of approximately 16 employees, underscoring its focus on managing its remaining assets and corporate structure.

The company's strategy is currently steered by this small team, focusing on potential mergers, asset sales, and managing its intellectual property (IP) like its toll-like receptor (TLR) agonists platform.

Statera Biopharma, Inc. (STAB) Mission and Values

Statera Biopharma, Inc.'s purpose extends beyond its current micro-cap valuation of approximately $7,258 as of late November 2025; its cultural DNA is rooted in the complex science of immune system balance, or what they call 'homeostasis.' The company's core mission is to develop next-generation immune therapies that restore this balance, targeting diseases where the immune system is dysfunctional, like autoimmune disorders and cancers.

Given Company's Core Purpose

You're looking at a company that is trying to tackle some of the hardest diseases, but their financial reality is tough-they reported a net loss of over $95.43 million on just $3.69 million in revenue over the last twelve months. Still, the core purpose remains focused on the science, which is what matters for a clinical-stage biopharma company, defintely more than the day-to-day stock price of $0.0001.

Official mission statement

The company's mission is centered on leveraging its proprietary platform to create immunotherapies that rebalance the body's immune system. This is a complex, multi-component approach, not a simple one-target drug. To be fair, this is a much more comprehensive goal than most biotechs state.

• Develop novel immunotherapies for autoimmune, infectious diseases, and cancers.
• Utilize the proprietary Advanced Immunomodulating Multi-Component System (AIMS) platform.
• Restore immune system homeostasis (balance) through pleiotropic (multi-effect) drug effects.

Vision statement

Statera Biopharma's long-term aspiration is to fundamentally shift how the medical community and patients view immunotherapy. They want their platform to be the gold standard for immune restoration, not just immune suppression or stimulation.

• Change the way people think about immunotherapy.
• Harmonize the 'immune orchestra' to treat disease and resolve inflammation.
• Achieve therapeutic benefits not possible with single-target immunotherapies.

Given Company slogan/tagline

Their most consistent, plain-English tagline cuts straight to the point of their scientific focus. It's a clean one-liner that summarizes the entire platform.

• Restoring Immune Health.

This commitment to rebalancing the immune system is the lens through which you must view their pipeline, which includes clinical programs like STAT-201 for Crohn's disease. If you want a deeper dive into the numbers supporting this mission, you should check out Breaking Down Statera Biopharma, Inc. (STAB) Financial Health: Key Insights for Investors. Finance: Assess the cash burn rate against the next clinical milestone announcement to see if the mission can survive the current financial strain.

Statera Biopharma, Inc. (STAB) How It Works

Statera Biopharma, Inc. operates as a clinical-stage biopharmaceutical company, creating novel immunotherapies by focusing on rebalancing the body's immune system, a process called immune restoration and homeostasis. The company generates revenue primarily through strategic out-licensing of its most advanced drug candidates, like the 2025 deal for Entolimod, while continuing to develop its remaining pipeline of Toll-like Receptor (TLR) agonists and antagonists.

Statera Biopharma's Product/Service Portfolio

As of late 2025, Statera Biopharma's value proposition is split between its remaining clinical-stage assets and the potential milestone payments from its licensed programs. The company's focus is on the Advanced Immunomodulating Multi-component System (AIMS) platform, which yields candidates like the STAT-200 series.

Statera Biopharma's Operational Framework

The company's operational model is lean, centered on the research and development (R&D) of its proprietary platform, then seeking non-dilutive capital through strategic partnerships and out-licensing. With a market capitalization of approximately $7.14 thousand and a trailing 12-month net loss of $91.83 million as of late 2025, the model is built on monetizing intellectual property (IP) to fund the next stage of R&D.

• IP-Centric R&D: The core operation is the Advanced Immunomodulating Multi-component System (AIMS) platform, which uses a multi-target approach, rather than a single factor, to harmonize the immune system.
• Strategic Out-Licensing: The February 2025 deal with Tivic Health Systems, Inc. for Entolimod is the clearest example, providing an initial $1.5 million in cash and equity consideration to Statera Biopharma for the exclusive worldwide rights. This is how they make money right now.
• Pipeline Advancement: Operations include managing ongoing clinical trials for the STAT-200 series (STAT-201, STAT-205) and seeking further partnerships for these programs, which is a key stated goal.
• Minimal Overhead: The company maintains a small operational footprint, with a reported 46 total employees in the last 12 months, keeping fixed costs low for a clinical-stage biopharma. That's a small team for a multi-program pipeline.

Statera Biopharma's Strategic Advantages

Statera Biopharma's competitive edge comes from its unique scientific approach and its recent, decisive financial maneuver to secure funding and advance its lead asset through a partner.

• Pan-TLR Platform Differentiation: The proprietary platform targets multiple Toll-like Receptors (TLRs) and intracellular pathways simultaneously, a 'Pan-TLR' approach, which aims to restore immune balance (homeostasis) rather than just blunting or exaggerating a single immune factor. This multi-pronged attack is defintely a scientific advantage in complex diseases.
• De-risked Asset Advancement: The licensing of Entolimod to Tivic Health Systems, Inc. in 2025 shifts the substantial cost and execution risk of late-stage development (Phase 3 and BLA filing) to the partner. Statera Biopharma retains the potential for future milestone and royalty payments without the immediate financial burden.
• Orphan Drug Status: The Orphan Drug Designation for STAT-201 in pediatric Crohn's Disease provides market exclusivity (seven years post-approval) and tax credits, which is a significant commercial advantage for a niche market.

For a deeper dive into the company's long-term vision, you should review the Mission Statement, Vision, & Core Values of Statera Biopharma, Inc. (STAB).

Statera Biopharma, Inc. (STAB) How It Makes Money

Statera Biopharma, Inc. is a clinical-stage biopharmaceutical company, meaning it does not sell commercialized drugs; instead, it generates revenue primarily by monetizing its intellectual property (IP) through licensing agreements and strategic collaborations with other pharmaceutical companies.

The company's financial engine is built on upfront payments, milestone achievements, and potential future royalties tied to the development of its proprietary immunotherapies, like the Toll-like Receptor (TLR) agonists, which are designed to rebalance the body's immune system and restore homeostasis. It's a classic biotech model: sell the rights to a promising drug candidate to fund the rest of your pipeline. That's the quick math.

Statera Biopharma's Revenue Breakdown

As of the trailing twelve months (TTM) ending in mid-2025, Statera Biopharma's total revenue was approximately $3.69 million. This revenue is almost entirely non-recurring and tied to strategic transactions, most notably the licensing of its lead drug candidate.

The vast majority of the TTM revenue is attributed to Licensing/Collaboration Revenue, specifically following the February 2025 deal where Tivic Health acquired exclusive worldwide rights to the Phase III TLR5 Agonist, Entolimod. This single event drives the 'Increasing' growth trend for this stream, but it's a one-time injection of cash, not a sustainable sales stream.

Business Economics

The economics of Statera Biopharma are typical of a pre-commercial, clinical-stage biotech, characterized by high operating burn and a non-existent or highly volatile gross margin. The company's core value is its intellectual property (IP) and its pipeline of drug candidates for conditions like Crohn's disease (STAT-201) and hematology (Entolimod).

• Pricing Strategy: The company does not have a conventional product pricing strategy. Its 'price' is the valuation of its IP, which is realized through non-dilutive financing mechanisms like licensing deals, collaboration agreements, and milestone payments.
• Cost Structure: The cost of goods sold (COGS) is minimal or non-existent, but operating expenses are dominated by Research and Development (R&D) and General and Administrative (G&A) costs. R&D costs are the engine, funding clinical trials and drug discovery.
• Economic Fundamentals: The business operates at a significant net loss, which is expected for a company in the development phase. The primary financial risk is the need for continuous capital to fund clinical trials, which often comes from equity raises, further diluting shareholders.

To be fair, the company's long-term viability hinges entirely on the successful development and commercialization of one of its drug candidates, or securing a major acquisition. You can read more about their focus here: Mission Statement, Vision, & Core Values of Statera Biopharma, Inc. (STAB).

Statera Biopharma's Financial Performance

The financial metrics as of November 2025 paint a clear picture of a company facing severe liquidity and operational challenges, which is defintely a high-risk scenario for investors.

• Total Revenue (TTM): Approximately $3.69 million. This is a crucial, but non-recurring, lifeline.
• Net Loss (TTM): The company reported a substantial net loss in the trailing twelve months, ranging from approximately -$91.83 million to -$95.43 million. This shows the massive cost of running a clinical-stage biopharma pipeline.
• Market Capitalization: The market valuation is extremely low, sitting around $7.14 thousand to $7,258.00 as of November 2025. This tiny market cap reflects the significant risk and the stock's low price point of $0.0001 per share.
• Cash Position: Cash and cash equivalents are critically low, at approximately $506,098. This cash position suggests a very short runway, underscoring the immediate need for new financing or a further strategic asset sale.
• Return on Equity (ROE): The ROE is deeply negative, at approximately -286.94%, indicating that the company is destroying shareholder value at a rapid pace to fund its operations.

Here's the quick math: with a TTM net loss over $91 million and only about $506K in cash, the company's ability to continue as a going concern is highly questionable without immediate, substantial capital infusion.

Statera Biopharma, Inc. (STAB) Market Position & Future Outlook

Statera Biopharma, Inc. is a micro-cap, clinical-stage biopharmaceutical company with a market position defined by its proprietary Advanced Immunomodulating Multi-component System (AIMS) platform, but its future hinges on the success of licensed assets and the progression of its internal pipeline, particularly STAT-201. The company's financial profile as of November 2025 shows extreme capital constraints, with a market capitalization of just over $7 thousand and a net loss of $91.83 million over the last twelve months, making it a high-risk, high-reward proposition.

You can get a deeper dive into the financials here: Breaking Down Statera Biopharma, Inc. (STAB) Financial Health: Key Insights for Investors.

Competitive Landscape

In the small-cap biopharma space, Statera Biopharma competes for investor capital and clinical pipeline success, not commercial market share yet. Their competitive standing is best gauged by relative market size and the promise of their core technology, the Toll-Like Receptor (TLR) agonists and antagonists.

Here's the quick math: I'm using the relative market capitalization of these three micro-cap peers as a proxy for market share in the investment landscape, as none have significant commercial revenue. Scopus BioPharma and Syros Pharmaceuticals are simply bigger targets for now.

Opportunities & Challenges

The company's near-term trajectory is a classic biotech gamble, balancing potential blockbuster development with chronic capital needs. They need a Phase 3 win, defintely.

Industry Position

Statera Biopharma is positioned as a high-risk, micro-cap player focused on immune system modulation, an area of high scientific interest. Its strength lies in its portfolio of Toll-Like Receptor (TLR) agonists and antagonists, which target the innate immune system to treat complex diseases like cancer, autoimmune disorders, and infectious diseases.

• Platform Focus: The AIMS platform is a core differentiator, giving the company a technology-driven edge over competitors with single-asset pipelines.
• Strategic Pivot: The licensing of Entolimod was a crucial strategic move in 2025, shifting the financial burden and risk of its most advanced asset to a partner, Tivic Health Systems, while retaining a potential upside via milestones.
• Valuation Reality: Despite the promising pipeline, the market values Statera Biopharma at a minuscule $7.258 thousand market cap as of November 2025, reflecting the overwhelming risk associated with its poor balance sheet and the long, costly road to drug commercialization.