Cue Biopharma, Inc. (CUE) Bundle
Ever wondered how Cue Biopharma, Inc. (CUE) is pioneering selective immune modulation therapies? With research and development expenses running at approximately $12 million per quarter in early 2024 and advancing its unique Immuno-STAT™ platform, this clinical-stage company is tackling challenging diseases like cancer and autoimmune conditions head-on. Despite the inherent risks of biopharmaceutical development, CUE continues to push its candidates through clinical trials, holding a cash position projected to fund operations into 2025. But what truly underpins its strategy, and how does it plan to navigate the complex path to commercialization? Let's delve into the history, ownership, and operational mechanics driving this innovative firm.
Cue Biopharma, Inc. (CUE) History
Cue Biopharma's Founding Timeline
Year established
The company was initially incorporated as Torus Bioscience, Inc. in Delaware on December 31, 2014. It subsequently changed its name to Cue Biopharma, Inc. in 2016.
Original location
Cue Biopharma established its headquarters and primary operations in Cambridge, Massachusetts, a major hub for biotechnology innovation.
Founding team members
The company was built upon scientific foundations from researchers including Steven Almo, Ph.D., at the Albert Einstein College of Medicine. Early leadership included Daniel Passeri (CEO) and Anish Suri (CSO), who were instrumental in translating the science into a therapeutic platform.
Initial capital/funding
Early funding came through seed investments and venture capital. A significant early step was securing approximately $10 million in a Series A financing round completed in 2016, enabling the initial development of its Immuno-STAT™ platform technology.
Cue Biopharma's Evolution Milestones
Year | Key Event | Significance |
---|---|---|
2016 | Renamed to Cue Biopharma; Series A funding | Solidified brand identity and secured capital for platform development. |
2017 | Initial Public Offering (IPO) on NASDAQ (CUE) | Raised approximately $66.2 million, providing substantial capital for R&D and clinical advancement. This move significantly impacted the company's financial structure, a topic explored further in Breaking Down Cue Biopharma, Inc. (CUE) Financial Health: Key Insights for Investors. |
2019 | Collaboration with Merck initiated; IND filed for CUE-101 | Major pharma partnership validated the platform; regulatory clearance paved the way for first-in-human trials. |
2020 | First patient dosed in Phase 1 trial of CUE-101 | Marked the transition to a clinical-stage company, testing its lead candidate in patients. |
2021 | Collaboration with LG Chem initiated; IND filed for CUE-102 | Expanded pipeline potential through another key partnership and advanced a second candidate to clinical stage. |
2022 | Reported positive Phase 1 data for CUE-101; First patient dosed in Phase 1 for CUE-102 | Demonstrated early clinical proof-of-concept for lead asset and initiated human trials for the second asset. |
2023 | Pipeline prioritization and updated CUE-101 data | Focused resources on most promising programs and shared encouraging clinical results, refining strategic direction. |
2024 | Continued CUE-101 Phase 1b expansion; Advanced CUE-102 and preclinical work | Focused on generating more robust clinical data for lead programs while managing capital. Reported cash and equivalents of $51.9 million as of Sept 30, 2024. |
Cue Biopharma's Transformative Moments
Pioneering the Immuno-STAT™ Platform
The core scientific innovation allowing selective T cell modulation formed the company's foundation, differentiating it in the competitive immunotherapy landscape.
Executing the Initial Public Offering (IPO)
Transitioning to a public company in 2017 provided access to significant capital markets, fueling ambitious clinical development plans that would have been difficult with private funding alone.
Securing Major Pharmaceutical Partnerships
Collaborations, particularly with Merck and LG Chem, provided crucial non-dilutive funding, external validation of the technology platform, and potential pathways for future development and commercialization, significantly de-risking aspects of the business model.
Cue Biopharma, Inc. (CUE) Ownership Structure
Cue Biopharma operates as a publicly traded entity, meaning its shares are available for purchase on the open market, leading to a diverse ownership base primarily composed of institutional investors, the general public, and company insiders.
Cue Biopharma, Inc. (CUE) Current Status
As of the end of 2024, Cue Biopharma, Inc. is a publicly traded company. Its common stock is listed on the Nasdaq Capital Market under the ticker symbol CUE.
Cue Biopharma, Inc. (CUE) Ownership Breakdown
Understanding who holds the shares provides insight into stakeholder confidence and potential influences on company direction. Analyzing the company's fiscal condition is equally vital, which you can explore further in Breaking Down Cue Biopharma, Inc. (CUE) Financial Health: Key Insights for Investors. Below is an approximate breakdown of ownership based on data available towards the end of 2024:
Shareholder Type | Ownership, % | Notes |
---|---|---|
Institutional Investors | ~58% | Includes mutual funds, pension funds, and other large financial institutions. |
General Public & Retail Investors | ~39% | Shares held by individual investors. |
Insiders | ~3% | Shares held by company executives, directors, and employees. |
Cue Biopharma, Inc. (CUE) Leadership
The strategic direction and day-to-day operations are guided by an experienced management team. Key figures leading the company as of late 2024 included:
- Daniel Passeri, M. Sc., J.D. - Chief Executive Officer
- Anish Suri, Ph.D. - President and Chief Scientific Officer
- Kerri-Ann Millar, CPA - Chief Financial Officer
Cue Biopharma, Inc. (CUE) Mission and Values
Understanding a company's mission and core values offers a glimpse into its fundamental purpose and guiding principles, shaping its strategic direction and culture. These elements define what the organization strives to achieve beyond just financial returns.
The Company's Core Purpose
At its heart, the company is focused on pioneering selective immunotherapies. Its efforts are geared towards harnessing the body's immune system in highly specific ways.
Official mission statement
The stated mission is to engineer a new class of injectable biologics, the Immuno-STAT™ platform, designed to selectively engage and modulate disease-specific T cells directly within the patient's body. This approach aims to treat cancers and autoimmune diseases effectively.
Vision statement
While a distinct formal vision statement isn't always prominently published, the company's activities and communications point towards a vision of transforming the treatment landscape for immune-related diseases. They aim to offer patients targeted therapies with potentially improved efficacy and safety profiles compared to broader immune system activation or suppression methods. Achieving this vision is intrinsically linked to its operational execution and financial stability, aspects explored in Breaking Down Cue Biopharma, Inc. (CUE) Financial Health: Key Insights for Investors.
Company slogan
A specific company slogan is not widely marketed or easily identifiable from public corporate materials as of early 2024.
Cue Biopharma, Inc. (CUE) How It Works
Cue Biopharma engineers biologic drugs designed to selectively engage and modulate disease-relevant T cells directly within the patient's body. Their core technology, the Immuno-STAT™ (Selective Targeting and Alteration of T cells) platform, forms the basis for developing targeted immunotherapies.
Cue Biopharma's Product/Service Portfolio
As a clinical-stage company, Cue Biopharma focuses on developing therapeutic candidates rather than selling commercial products as of late 2024. Its revenue primarily stems from strategic collaborations, such as the ongoing partnership with LG Chem which generated $1.5 million in Q3 2024.
Product Candidate | Target Market | Key Features |
---|---|---|
CUE-101 | HPV+ Head and Neck Cancer (First-line setting in combination, Monotherapy in second-line+) | Fusion protein incorporating IL-2 and a pMHC derived from the HPV16 E7 protein. Currently in Phase 1b trials. |
CUE-102 | WT1-Positive Cancers (Various solid tumors and hematologic malignancies) | Fusion protein incorporating IL-2 and a pMHC derived from the Wilms’ Tumor 1 (WT1) protein. Currently in Phase 1 dose escalation and expansion trials. |
CUE-103 & Pipeline | KRAS G12V mutation positive cancers and other oncology/autoimmune targets | Additional Immuno-STAT candidates leveraging the platform for various mutations and disease targets. Preclinical and early development stages. |
Cue Biopharma's Operational Framework
The company's operations revolve around research and development (R&D) and clinical trials. Significant resources, approximately $11.1 million in R&D expenses for the third quarter of 2024, are invested in advancing their pipeline candidates through preclinical studies and human clinical trials. They manage complex trial logistics, patient enrollment, and data analysis, often collaborating with Contract Research Organizations (CROs) and clinical sites. Manufacturing of their complex biologics is typically outsourced to specialized Contract Manufacturing Organizations (CMOs). Funding operations relies heavily on equity financing and collaboration payments, maintaining a cash and equivalents balance of around $50.2 million as of September 30, 2024, to support these activities.
Cue Biopharma's Strategic Advantages
Cue Biopharma's primary competitive edge lies in its proprietary Immuno-STAT platform technology. This platform allows for the creation of biologics designed for selective T cell modulation, potentially offering advantages in efficacy and safety compared to broader immunotherapies.
- Specificity: The platform aims to target only the relevant T cell populations, potentially minimizing off-target side effects associated with systemic immune activation.
- Modular Design: The Immuno-STAT framework is adaptable, allowing the company to theoretically develop candidates for a wide range of antigens and T cell targets across oncology and autoimmune diseases.
- Strategic Partnerships: Collaborations, like the significant one with LG Chem focused on Asian markets, provide external validation, non-dilutive funding (milestone payments and research support), and potential pathways to broader markets. Understanding who invests can offer further insights, as detailed in Exploring Cue Biopharma, Inc. (CUE) Investor Profile: Who’s Buying and Why?
- Focused Pipeline: By concentrating on lead candidates like CUE-101 and CUE-102 in defined patient populations, the company can direct resources effectively towards achieving clinical milestones.
Cue Biopharma, Inc. (CUE) How It Makes Money
As a clinical-stage biopharmaceutical company, Cue Biopharma primarily generates revenue through strategic collaborations and licensing agreements with larger pharmaceutical companies. These partnerships provide upfront payments, milestone payments tied to research, development, and regulatory achievements, and potential future royalties on product sales.
Cue Biopharma, Inc.'s Revenue Breakdown
Revenue Stream | % of Total (FY 2024 Est.) | Growth Trend |
---|---|---|
Collaboration Revenue | ~98% | Stable |
Grant Revenue | ~2% | Decreasing |
Cue Biopharma, Inc.'s Business Economics
The company operates within the high-risk, high-reward economics of drug development. Its financial model hinges on significant upfront investment in research and development (R&D), funded by equity financing and collaboration payments. Key economic drivers include:
- R&D Intensity: A substantial portion of capital is allocated to advancing its Immuno-STAT™ platform and pipeline candidates through preclinical and clinical trials. R&D expenses typically represent the largest operating cost.
- Partnership Dependency: Near-term revenue relies heavily on achieving milestones defined in collaboration agreements, like the one with LG Chem. This provides non-dilutive funding but links revenue to specific development outcomes.
- Long Development Timelines: Bringing a drug to market takes many years and significant capital, creating a long period before potential product revenue can be realized.
- Platform Value Proposition: The core economic potential lies in validating the Immuno-STAT™ platform's ability to generate multiple drug candidates, potentially leading to further partnerships or future commercialization. The company's focus aligns with its strategic goals, further detailed in the Mission Statement, Vision, & Core Values of Cue Biopharma, Inc. (CUE).
Cue Biopharma, Inc.'s Financial Performance
As of the end of fiscal year 2024, Cue Biopharma remains in the development stage, reflected in its financial profile. Total revenue for 2024 was primarily driven by its collaboration agreements, estimated around $7.5 million. Consistent with its clinical-stage status, the company reported a significant net loss, projected to be approximately $70 million for the year, largely due to substantial R&D investments essential for advancing its pipeline. Research and development expenses were estimated at $55 million in 2024. The company's cash, cash equivalents, and marketable securities position at year-end 2024 is crucial for funding future operations, estimated to be around $40 million, highlighting the ongoing need for capital management and potentially further financing or partnership milestones to extend its operational runway.
Cue Biopharma, Inc. (CUE) Market Position & Future Outlook
Cue Biopharma operates as a clinical-stage company leveraging its proprietary Immuno-STAT™ platform to develop targeted immunotherapies. Its future outlook hinges significantly on advancing its lead candidates through clinical trials and validating the platform's potential in oncology and autoimmune diseases.
Competitive Landscape
Company | Market Share, % | Key Advantage |
---|---|---|
Cue Biopharma | 0% | Selective T-cell engagement via Immuno-STAT™ platform aiming for improved safety/efficacy profile. |
Amgen | Significant (in relevant areas) | Pioneer in BiTE® (Bispecific T-cell Engager) technology with approved products and substantial resources. |
Regeneron Pharmaceuticals | Significant (in relevant areas) | Strong portfolio of approved antibodies and bispecifics developed via VelociSuite® technologies, robust commercial presence. |
Opportunities & Challenges
Opportunities | Risks |
---|---|
Validation of Immuno-STAT™ platform through positive clinical data (e.g., CUE-101, CUE-102). | Clinical trial failures or significant delays impacting pipeline progression. |
Expansion of the platform into autoimmune and inflammatory diseases. | High dependency on external funding due to significant R&D costs ($10.1 million in Q3 2024) and lack of revenue; cash reserves were $68.7 million as of Sep 30, 2024. |
Potential for lucrative partnerships or licensing agreements with larger pharmaceutical companies. | Intense competition within the immuno-oncology and autoimmune therapeutic spaces from established players and emerging biotechs. |
Addressing significant unmet medical needs in targeted patient populations. | Navigating complex and lengthy regulatory approval pathways (FDA, EMA). |
Industry Position
Positioned within the rapidly evolving immuno-oncology sector, the company differentiates itself through its unique Immuno-STAT platform designed for selective T-cell modulation without broad immunosuppression or activation. As a clinical-stage entity, it currently holds no market share, focusing resources entirely on research and development, a critical factor detailed when Breaking Down Cue Biopharma, Inc. (CUE) Financial Health: Key Insights for Investors. Its standing relies heavily on future clinical success and potential validation against more established therapeutic modalities like checkpoint inhibitors and CAR-T therapies, aiming to carve out a niche based on targeted efficacy and safety.
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