Cue Biopharma, Inc. is a biopharmaceutical company developing precision immunotherapies for cancer and autoimmune diseases utilizing its proprietary Immuno-STAT™ platform.

# Company Summary: Cue Biopharma, Inc.

## Business Overview
- **Industry:** Biopharmaceuticals / Immunotherapy  
- **Focus:** Developing precision immunotherapies targeting cancer and autoimmune diseases using a proprietary platform called **Immuno-STAT™**.

## Core Technologies and Programs
- **Immuno-STAT™ Platform:** A modular, injectable biologic designed to selectively modulate disease-relevant T cells by mimicking natural "command and control" immune signals.
- **Key Programs:**
  - **CUE-100 Series (Oncology):**  
    - Targets tumor-specific T cells.  
    - Lead candidates include **CUE-101** (for HPV+ cancers) and **CUE-102** (for WT1-expressing cancers).  
    - Clinical trials: Ongoing Phase 1b for CUE-101 and CUE-102.
  - **CUE-400 Series (Autoimmune Diseases):**  
    - Designed to enhance regulatory T cells (**Tregs**) to restore immune balance.  
    - Lead candidate: **CUE-401** (demonstrated preclinical activity, IND-enabling studies underway).
  - **CUE-500 Series (Targeted Cell Depletion):**  
    - Redirects virus-specific T cells to deplete pathogenic cells, such as B cells in autoimmune diseases.  
    - Lead candidate: **CUE-501** (preclinical stage, seeking third-party partnership).

## Scientific Approach
- Uses peptide-HLA complexes to engage specific TCRs, delivering signals like IL-2 and TGF-β to selectively activate or generate immune cells.
- Differentiates from broad immune activation therapies by targeting disease-relevant T cell populations, thus minimizing off-target effects.
- Aims for therapies to become new standards in cancer and autoimmune treatment by restoring immune balance.

## Current Operational Status
- **Employees:** 41 full-time (as of December 31, 2024).  
- **Location:** Mainly based in Massachusetts, USA.  
- **Customers & Revenue:**  
  - No current revenue or commercialized products.  
  - No information provided about customer numbers or sales figures.
- **Financials (as of December 31, 2024):**  
  - **Cash and Cash Equivalents:** $22.5 million.  
  - **Accumulated Deficit:** $340.9 million.  
  - **Market Capitalization (most recent):** Approximately $59.9 million (as of June 28, 2024, based on stock closing price of $1.24/share).  
  - **Outstanding Shares:** 61,819,101 shares (as of March 27, 2025).

## Development & Regulatory Status
- Currently conducting Phase 1b clinical trials for CUE-101 and CUE-102.
- CUE-401 is in IND-enabling preclinical studies with plans for IND submission in Q3 2026.
- CUE-501 is in preclinical development, seeking third-party collaboration.
- License agreements include rights from Albert Einstein College of Medicine, with milestone payments up to $1.85 million per product and indication, totaling potential aggregate milestone payments of $5.75 million.

## Intellectual Property
- Maintains a broad patent portfolio: 145 issued patents (including 30 in the U.S.), and 379 pending applications (including 79 in the U.S.).
- Owns or has licensed key patents related to their platform and biologic candidates.

## Business Strategy
- Focus on advancing CUE-401 and CUE-501 toward clinical and partnership opportunities.
- Seek third-party collaborations for research, development, and commercialization.
- Leverage unique mechanism of action for strategic partnerships and potential high-impact therapeutics.

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*Note:* No actual commercial revenue, profit, or customer numbers have been provided in the documents. The firm is purely in the development stage, with ongoing clinical trials and preclinical studies.

A clinical-stage biopharmaceutical company developing a novel class of injectable therapeutics to modulate disease-relevant T cells for cancer and autoimmune diseases.

## Company Overview

### Business Description
We are a clinical-stage biopharmaceutical company focused on engineering a novel class of injectable therapeutics. Our primary goal is to selectively engage and modulate disease-relevant T cells directly within the patient’s body. Our proprietary platform, **Immuno-STAT™ (Selective Targeting and Alteration of T Cells)**, enables the modulation of targeted T cells to treat major diseases such as cancer and autoimmune diseases.

### Key Highlights
- **Therapeutic Approach**: We aim to enhance the patient’s immune system capacity to combat diseases while avoiding the harmful side effects associated with broad immune activation (in cancer) or immune suppression (in autoimmune diseases).
- **Core Products**:
  - **CUE-101**: Designed to target HPV+ head and neck squamous cell carcinoma.
  - **CUE-102**: Targets Wilms' Tumor 1 protein (WT1), known to be over-expressed in over 20 different cancers.
- We are also developing drug candidates targeting autoimmune diseases in collaboration with partners like **Ono Pharmaceutical Co., Ltd.**

### Operations and Workforce
- **Employees**: As of December 31, 2023, the company has **53 full-time employees**.
- **Clinical Trials**: Currently conducting Phase 1 trials for CUE-101 and CUE-102.
  
### Market Context
- **Clinical Coverage**: Approximately **20 million new cancer diagnoses** globally each year, with **2 million in the U.S.** alone.
- **Autoimmune Diseases**: Affect around **4% of the world’s population**, resulting in about **24 million cases in the U.S.**.

### Financial Summary
- **Current Revenue**: The company **does not currently generate commercial revenue** and has not yet commercialized any products.
- **Operating Losses**: As of December 31, 2023, the accumulated deficit stands at approximately **$301.1 million**.
  
### Collaboration and Licensing
- Engaged in **strategic collaborations** to support product development, including partnerships for funding and joint research efforts with prestigious entities and organizations.

### Future Prospects
The company plans to continue advancing its **CUE-100 series** while exploring additional therapeutic opportunities, relying significantly on external partnerships to support its expansive research and development agenda.

Cue Biopharma, Inc.

10-K / March 31, 2025

10-K / March 28, 2024

10-K / March 31, 2025

Company Summary: Cue Biopharma, Inc.

Business Overview

Core Technologies and Programs

Scientific Approach

Current Operational Status

Development & Regulatory Status

Intellectual Property

Business Strategy