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

Are you defintely tracking Cue Biopharma, Inc. (CUE), a small-cap biotech that's punching well above its weight in the immunotherapy space? This is a clinical-stage company with a market capitalization of only about $51.3 million, but its proprietary Immuno-STAT® platform is delivering clinical data that fundamentally challenges the standard of care for head and neck cancer, showing a confirmed Overall Response Rate of 50% in its CUE-101 trial, which is a massive jump from the 19% historical rate for the current frontline therapy alone. You need to understand how a company with Q3 2025 collaboration revenue of just $2.1 million can secure two major deals this year, including a $15 million upfront payment and a 40% equity stake in a partner company, ImmunoScape, because that's where the real valuation story is.

Honestly, the clinical results and the strategic partnerships with giants like Boehringer Ingelheim-which includes up to $345 million in potential milestones-are the only things that matter right now, not the $7.45 million quarterly net loss. How does their Immuno-STAT technology actually work to selectively target T cells, and can their lead autoimmune asset, CUE-401, replicate the success of their oncology programs?

Cue Biopharma, Inc. (CUE) History

You're looking for the foundational story of Cue Biopharma, Inc., and the core takeaway is this: it's a company born from a breakthrough platform technology, the Immuno-STAT™ (Selective Targeting and Alteration of T cells), that has had to make sharp, strategic pivots-most recently in 2025-to survive and advance its clinical pipeline.

The company started with a focus on cancer but has strategically shifted its primary focus to autoimmune disease, a clear sign of a trend-aware realist management team. This pivot, coupled with key partnerships, has been critical to extending its financial runway.

Given Company's Founding Timeline

Year established

The company was initially incorporated in Delaware as Torus Bioscience, Inc. on December 31, 2014. It officially changed its name to Cue Biopharma, Inc. in 2016.

Original location

Cue Biopharma established its headquarters and primary operations in Cambridge, Massachusetts, a key hub in the US biotechnology landscape.

Founding team members

The company was built on the scientific work of researchers like Steven Almo, Ph.D., at the Albert Einstein College of Medicine. Early leadership and scientific founders included:

• Steven Almo, Ph.D. (Scientific Founder)
• Daniel Passeri, M.Sc., J.D. (Early President and CEO)
• Anish Suri (Chief Scientific Officer)
• Rodolfo J. Chaparro, Ph.D. (Co-founder and Co-inventor)
• Ronald Seidel, Ph.D. (Co-founder and Co-inventor)

Initial capital/funding

Early funding was crucial for validating the Immuno-STAT™ platform. The company secured initial seed funding of $10 million in 2015, followed by a Series A financing. By early 2017, the total invested private capital stood at approximately $26 million.

Given Company's Evolution Milestones

Given Company's Transformative Moments

The company's trajectory has been defined by a few high-stakes decisions, particularly in 2025, that fundamentally reshaped its financial and clinical focus. The biggest shift was leveraging the Immuno-STAT™ technology (a biologic designed for selective T cell modulation) to target autoimmune diseases, not just cancer.

Here's the quick math on the recent financial moves: The Q3 2025 collaboration revenue was $2.1 million, but the key was the $12 million upfront payment from Boehringer Ingelheim in Q2 2025 and the $10 million cash component of the ImmunoScape upfront payment expected in Q4 2025. That non-dilutive funding is a defintely a lifeline.

• Pioneering the Immuno-STAT™ Platform: This core scientific innovation, allowing for precise, selective T cell modulation, is the single most important asset, differentiating the company from broader, less-specific immunotherapies.
• The 2025 Strategic Pivot: The company made a hard turn to prioritize its lead autoimmune asset, CUE-401, which is designed to re-establish immune tolerance. This was coupled with a 25% workforce reduction in July 2024 to manage the burn rate and extend the cash runway into mid-year 2025.
• CEO Transition in September 2025: The appointment of Usman Azam, M.D., a veteran with deep experience in cell and gene therapies from companies like Novartis, signaled a clear intent to execute on the new autoimmune-focused strategy and the novel cell therapy collaboration with ImmunoScape.

What this estimate hides is the Q3 2025 net loss of $7.4 million, which shows the ongoing challenge of funding a clinical-stage biotech. For a deeper dive into how they manage this, you should read Breaking Down Cue Biopharma, Inc. (CUE) Financial Health: Key Insights for Investors.

Cue Biopharma, Inc. (CUE) Ownership Structure

Cue Biopharma, Inc. operates as a publicly traded company on the NASDAQ, but its ownership is highly concentrated among institutional and retail investors, with a very small insider stake. This structure means strategic decisions are largely influenced by the institutional block and the collective sentiment of the broader market.

Cue Biopharma, Inc.'s Current Status

Cue Biopharma, Inc. is a clinical-stage biopharmaceutical company trading on the NASDAQ Stock Market under the ticker symbol CUE. It completed its Initial Public Offering (IPO) in January 2018. As of November 2025, the company's market capitalization stands at approximately $49.6 million, reflecting its position as a smaller, high-risk, high-reward biotech play focused on its Immuno-STAT platform. The company reported a net loss of $7.45 million in the third quarter of 2025, with collaboration revenue of $2.1 million, showing the financial challenges typical of a pre-commercial clinical-stage firm. If you want a deeper dive into the numbers, you can check out Breaking Down Cue Biopharma, Inc. (CUE) Financial Health: Key Insights for Investors.

Cue Biopharma, Inc.'s Ownership Breakdown

Looking at the shareholder data as of November 2025, the vast majority of the company is held by the public and institutional funds, which is typical for a small-cap biotech. Here's the quick math on who controls the shares:

The institutional ownership of 22.62% is significant because those large funds can defintely influence key votes, but the high retail ownership means stock price volatility is a constant risk.

Cue Biopharma, Inc.'s Leadership

The company's strategic direction is being steered by a new leadership team focused on advancing the autoimmune disease pipeline, particularly the CUE-401 candidate. A key transition occurred in late 2025.

• Usman 'Oz' Azam, M.D.: Appointed President and Chief Executive Officer (CEO) on September 29, 2025. He's tasked with driving the CUE-401 program toward clinical development.
• Daniel Passeri: Transitioned from CEO to Strategic Advisor, effective September 29, 2025, providing ongoing support.
• Pasha Sarraf, M.D., Ph.D.: Serves as the Chairman of the Board.

This leadership change, which occurred just two months before our November 2025 cutoff, signals a pivot toward prioritizing the autoimmune therapeutic candidates, a strategic move the Board believes will unlock long-term value. The new CEO brings over 25 years of drug development experience, so that's a positive sign for clinical execution.

Cue Biopharma, Inc. (CUE) Mission and Values

Cue Biopharma, Inc. is driven by a singular, ambitious goal: to fundamentally change how we treat cancer and autoimmune diseases by precisely reprogramming the body's own immune system. Their core purpose is to develop a new class of injectable biologics that offer patients dramatically improved therapeutic outcomes over current, less-targeted treatments.

Cue Biopharma, Inc.'s Core Purpose

You need to know what a company is trying to build, not just what it's earning. For Cue Biopharma, Inc., their cultural DNA is rooted in precision immunology-the idea that you can selectively target and alter disease-specific T cells without the systemic chaos of broad immune modulation. It's a high-risk, high-reward model, but the potential payoff is massive, both for patients and investors.

Here's the quick math on the capital markets' validation: In 2025 alone, the company secured an upfront payment of $12 million from a collaboration with Boehringer Ingelheim, plus another $15 million in upfront payments from a strategic deal with ImmunoScape, which is a significant injection of non-dilutive capital.

Official Mission Statement

The company's mission centers on the development of a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells directly within the patient's body. This isn't just about making another drug; it's about making a smarter one. Their commitment is to dramatically improve therapeutic outcomes for patients suffering from cancer and autoimmune disorders.

• Develop injectable biologics to selectively modulate disease-specific T cells.
• Provide patients with dramatically improved therapeutic outcomes.
• Harness the curative potential of the body's intrinsic immune system.

Vision Statement

The long-term vision is to establish a new standard of care for serious diseases that cause human suffering and mortality. They see a future where immune balance is restored through precision engineering, and they are putting their cash-which was $11.7 million as of September 30, 2025-behind that vision.

Their lead autoimmune asset, CUE-401, is a defintely a key part of this vision, designed to act as a master switch for regulatory T cell (Treg) differentiation and tolerance induction, which could address a major unmet need in autoimmune disease treatment.

• Establish a new standard of care for cancer and autoimmune diseases.
• Selectively modulate the immune system to restore function and re-establish immune balance.
• Leverage the proprietary Immuno-STAT™ platform to enhance a patient's immune system.

For a detailed look at how these ambitious goals translate into the company's financial standing, you should review Breaking Down Cue Biopharma, Inc. (CUE) Financial Health: Key Insights for Investors.

Cue Biopharma, Inc. Slogan/Tagline

While the company doesn't use a short, catchy slogan in their official communications, their technology platform's name acts as their de facto tagline, encapsulating their entire approach to medicine.

• Immuno-STAT®: Selective Targeting and Alteration of T cells.

This is their promise: highly targeted action. It's a crucial differentiator in the crowded biotech space, and the clinical data is starting to back it up, like the confirmed 50% Overall Response Rate (ORR) reported in the Phase 1 trial for CUE-101 in HPV+ head and neck cancer.

Cue Biopharma, Inc. (CUE) How It Works

Cue Biopharma is a clinical-stage biopharmaceutical company that designs injectable protein biologics to precisely reprogram the body's T cells, which are the immune system's specialized soldiers. Their approach, called $\text{Immuno-STAT}^{\text{TM}}$ (Selective Targeting and Alteration of T cells), delivers two specific signals directly to disease-specific T cells, essentially acting as a highly targeted immune system conductor for treating cancer and autoimmune disease.

You're looking for a clear picture of how this company makes money and drives value, and honestly, it's all about the platform technology and the strategic partnerships it enables. The value is in the intellectual property and the clinical progress, not commercial product sales yet.

Cue Biopharma's Product/Service Portfolio

The company's value is currently concentrated in its clinical pipeline, which is built on the modular $\text{Immuno-STAT}^{\text{TM}}$ platform. This platform allows for rapid development of different therapeutic candidates by swapping out the tumor- or disease-specific antigen (Signal 1) while keeping the engineered immune-modulating protein (Signal 2) consistent.

Cue Biopharma's Operational Framework

The company operates as a clinical-stage research and development (R&D) engine, meaning its core process is discovery, preclinical testing, and managing clinical trials. It's a lean, asset-focused model. Here's the quick math on their operations: For the nine months ended September 30, 2025, total R&D expenses were approximately $21.2 million ($8.5M in Q1, $7.9M in Q2, $4.8M in Q3), which is the primary driver of their cash burn.

• Platform-Centric Discovery: They use the $\text{Immuno-STAT}^{\text{TM}}$ platform to rapidly generate new drug candidates by simply changing the peptide-MHC (pMHC) component to target a different T-cell receptor (TCR) specificity.
• Strategic Partnering for Funding and Scale: Cue Biopharma generates revenue primarily through collaboration and license agreements, which also de-risk the pipeline. For example, the strategic collaboration with Boehringer Ingelheim for CUE-501 included a $12 million upfront payment in April 2025 and potential milestone payments of up to $345 million.
• Resource Optimization: The company announced a strategic realignment in 2024 to prioritize autoimmune programs and reduce its workforce by approximately 25% to cut operating expenses. This move projected an annual cash burn of about $30 million for fiscal year 2025.

The business model is simple: build a validated platform, generate promising clinical data, and then partner the assets for large, non-dilutive capital infusions to fund the next wave of R&D. Exploring Cue Biopharma, Inc. (CUE) Investor Profile: Who's Buying and Why?

Cue Biopharma's Strategic Advantages

Cue Biopharma's competitive edge is defintely rooted in the precision of its technology, which aims to solve the core problem of systemic toxicity in immunotherapy. They are not just another biotech; they are focusing on a differentiated mechanism of action.

• T-Cell Selectivity: The $\text{Immuno-STAT}^{\text{TM}}$ platform is designed to deliver both the antigen-specificity signal (Signal 1) and the T-cell activation signal (Signal 2) simultaneously, ensuring that the potent Interleukin-2 (IL-2) cytokine only activates the desired, disease-specific T cells. This avoids the severe, non-specific toxicity associated with older, systemic IL-2 therapies.
• Modular and Rapid Pipeline Expansion: The platform's plug-and-play nature means that once the core $\text{Immuno-STAT}^{\text{TM}}$ structure is validated, new candidates targeting different antigens can be developed more quickly and efficiently. This is a huge advantage in a field where drug discovery is often slow and expensive.
• High-Value Partnerships: Securing collaborations with major pharmaceutical players like Boehringer Ingelheim for CUE-501 and the recent November 2025 collaboration with ImmunoScape for the CUE-100 series validate the technology. The ImmunoScape deal, which includes an upfront payment of $10 million in Q4 2025 and a 40% equity stake in the partner company, provides both immediate capital and long-term upside.

What this estimate hides is the inherent risk of a clinical-stage company; one trial failure can wipe out years of progress. Still, the data on CUE-101's mOS of 32.7 months is a concrete, encouraging signal that the platform is working as designed in the clinic.

Cue Biopharma, Inc. (CUE) How It Makes Money

Cue Biopharma, Inc. is a clinical-stage biopharmaceutical company, so it generates 100% of its current revenue not from selling drugs, but from strategic research collaboration and licensing agreements with larger pharmaceutical partners, essentially monetizing its Immuno-STAT (Selective Targeting and Alteration of T cells) platform technology before commercialization.

This model is typical for a biotech firm still in clinical trials; they bring in non-dilutive capital-money that doesn't require issuing more shares-by having partners fund the development of specific drug candidates and pay for the rights to future sales. Honestly, until a drug is approved and on the market, these partnership payments are the entire financial engine.

Cue Biopharma's Revenue Breakdown

For a pre-commercial business like this, the revenue is a single stream, but it's crucial to see the trend. The Q3 2025 data shows a clear picture of where the money comes from and how it's flowing.

The total collaboration revenue for the third quarter of 2025 was $2.1 million. This is a 35.6% decline from the $3.3 million reported in the third quarter of 2024. The decrease is due to the timing of revenue recognition from different agreements, specifically the Boehringer Ingelheim International GmbH (BI) agreement in 2025 versus the Ono Collaboration and Option Agreement in 2024, which was terminated in March 2025. Still, the new ImmunoScape collaboration announced in November 2025, which includes a $15 million upfront package, will hit the books in Q4 2025, with $10 million scheduled for that quarter, which will immediately reverse this near-term decline.

Business Economics

The economics of Cue Biopharma are less about pricing a product and more about valuing the intellectual property (IP) and the clinical-stage risk. The core value lies in the Immuno-STAT platform, which is a novel class of therapeutic biologics designed to selectively modulate disease-specific T cells for cancer and autoimmune diseases.

Here's the quick math on how they structure value:

• Upfront Cash Payments: This is immediate, non-dilutive capital to fund R&D. For example, the Boehringer Ingelheim agreement for CUE-501 included a $12 million upfront payment. The ImmunoScape deal added another $15 million total upfront package.
• Milestone Payments: These are conditional payments tied to achieving specific clinical, regulatory, or commercial goals. The Boehringer Ingelheim deal, for instance, has potential milestone payments totaling approximately $345 million. This is the long-term, high-value component of the business model.
• Equity Stakes: The recent ImmunoScape collaboration included a 40% equity stake in ImmunoScape, giving Cue Biopharma a strategic, non-cash asset and exposure to a cell-therapy program.
• Cost Structure: The primary cost is Research and Development (R&D). In Q3 2025, R&D expenses were $4.8 million, which was actually a significant reduction from $9.4 million in Q3 2024, driven by lower clinical trial costs for the CUE-100 series. This cost control is defintely a key to extending their cash runway.

The company's long-term sustainability hinges on converting these collaboration revenues into future product royalties, which is the ultimate goal. You can find more details on their long-term strategy in their Mission Statement, Vision, & Core Values of Cue Biopharma, Inc. (CUE).

Cue Biopharma's Financial Performance

As of November 2025, the company's financial health is characterized by strategic capital raises and tightened operational spending, but still reflects the high-burn nature of a clinical-stage biotech.

• Net Loss: The net loss for Q3 2025 was $7.4 million, which is an improvement, narrowing by 14.0% from the $8.66 million loss in Q3 2024.
• Cash Position: Cash and cash equivalents stood at $11.7 million as of September 30, 2025. This cash on hand is quickly burned, but the Q4 2025 ImmunoScape payment will provide a critical boost.
• Operating Expenses: Total operating expenses for Q3 2025 were $9.7 million, with General and Administrative (G&A) expenses rising to $4.9 million due to a one-time employee severance accrual.
• Diluted EPS: The diluted Earnings Per Share (EPS) for the last twelve months is -$0.44, indicating the ongoing challenge of profitability.
• Valuation Metrics: The company's valuation is speculative, trading at a Price-to-Sales (P/S) Ratio of 5.43 as of November 2025. For a company with no product revenue, this ratio reflects the market's valuation of its pipeline and Immuno-STAT platform potential.

The company's ability to continue advancing its lead autoimmune asset, CUE-401, and its oncology programs depends entirely on the successful execution of these collaboration agreements and the receipt of future milestone payments.

Cue Biopharma, Inc. (CUE) Market Position & Future Outlook

Cue Biopharma, Inc. is positioned as a high-risk, high-potential clinical-stage biotech, strategically pivoting to focus its limited capital on the autoimmune space while leveraging promising early oncology data through non-dilutive partnerships. Your investment thesis here hinges entirely on the clinical success of the Immuno-STAT platform (Selective Targeting and Alteration of T cells) to deliver an injectable, off-the-shelf alternative to complex cell therapies, especially as the company navigates a challenging financial runway with a Q3 2025 net loss of $7.4 million.

Competitive Landscape

In the broader T-cell therapy market, which is projected to be around $6.5 billion in 2025, Cue Biopharma holds a negligible commercial market share due to its clinical-stage status. The company's competitive standing is measured by the potential of its Immuno-STAT platform to disrupt the established, expensive CAR T-cell therapy market dominated by large pharmaceutical players. Here's a snapshot of the landscape as of late 2025:

Opportunities & Challenges

The company's strategic shift and recent collaborations map out clear near-term opportunities, but they are shadowed by acute financial risks. The Altman Z-Score of -13.7 in late 2025 places the company in the financial distress zone, making execution on milestones absolutely defintely critical.

Industry Position

Cue Biopharma's position is that of a technology innovator in a capital-intensive, high-barrier-to-entry market. Its Immuno-STAT platform is a next-generation approach to T-cell modulation, seeking to overcome the manufacturing and toxicity issues of current CAR T-cell therapies (which require harvesting, engineering, and re-infusing a patient's own T-cells).

• The core value proposition is moving T-cell therapy from an expensive, complex ex vivo (outside the body) process to a scalable, affordable in vivo (inside the body) injectable biologic.
• The Q3 2025 collaboration revenue of $2.15 million-while a miss-underscores the importance of partnerships for non-dilutive funding, especially with a 3-year revenue growth of -29.9%.
• The strategic shift to prioritize autoimmune diseases is smart, as the Immuno-STAT platform's ability to selectively turn off T-cells (tolerogenic function) could be a breakthrough in a large market where current treatments are broadly immunosuppressive.

To understand the full financial context behind these strategic decisions, you should read Breaking Down Cue Biopharma, Inc. (CUE) Financial Health: Key Insights for Investors.

Your immediate focus should be tracking the actual receipt of the $10 million ImmunoScape payment in Q4 2025 and the clinical progress of CUE-401.