Imagine a "precision immunotherapy lab" focused on designing smart biologic drugs to specifically activate your immune system's T-cells to fight diseases. Cue Biopharma is building this next generation of targeted immune therapies, much like a specialized, early-stage Genentech or Amgen.

Think of Cue Biopharma as a company developing highly specific "on-switches" for your immune system. They're creating novel biologic drugs to precisely instruct T-cells to attack cancers and other serious illnesses, similar to how a more targeted Merck might evolve its immunotherapy approach beyond broad checkpoint inhibitors.

• CUE-101: A fusion protein biologic in Phase 1b clinical trial designed to activate T cells for human papilloma virus-driven cancers.
• CUE-102: A fusion protein biologic designed to target and activate antigen-specific T cells to fight cancers.
• CUE-103: A CUE-100 series Immuno-STAT targeting the KRAS G12V mutation for various cancers including colorectal, lung, and pancreatic.
• CUE-200: A drug framework that focuses on cell surface receptors to address T cell exhaustion associated with chronic infections.
• CUE-300 framework: A drug framework developed to target various autoimmune diseases.
• CUE-400 framework: A drug framework developed to target various autoimmune diseases.

Cue Biopharma (CUE) is a clinical-stage biopharmaceutical company focused on the research and development of biologic drugs. As such, it does not currently sell drugs directly to individuals or through traditional distribution channels. Its revenue primarily stems from collaboration agreements and partnerships with other companies and research institutions.

Based on the provided information, Cue Biopharma's major customers and partners include:

• Merck Sharp & Dohme Corp. (Symbol: MRK)
• LG Chem Life Sciences (part of LG Chem, Symbol: 051910.KS)
• Albert Einstein College of Medicine

Usman “Oz” Azam, M.D. President and Chief Executive Officer

Dr. Azam brings over 25 years of leadership experience in drug discovery, development, and operations to Cue Biopharma. He previously served as Chief Executive Officer of Inspirna, Inc., a privately held clinical-stage biopharmaceutical company, and Empyrean Neuroscience, a genetic engineering company. He was also the President and CEO of Tmunity Therapeutics, which developed genetically engineered CAR-T cell therapies. Prior to these roles, Dr. Azam was the Global Head of the Cell and Gene Therapies unit at Novartis, where he played a key role in the launch of the first-ever FDA-approved CAR-T cell therapy. His career also includes leadership positions at Pfizer Pharmaceuticals, Aspreva Pharmaceuticals, Johnson & Johnson, and GlaxoSmithKline (GSK).

Lucinda Warren Chief Financial Officer and Business Officer

Ms. Warren has over 30 years of global experience in the pharmaceutical and biotechnology sectors. Before joining Cue Biopharma, she was the Vice President of Business Development for Neuroscience and Japan Regionally at Johnson & Johnson from 2014 to 2024. In this role, she was responsible for end-to-end business development, including licensing, mergers and acquisitions, and alliance management. Ms. Warren has also held leadership positions at Janssen Cilag Australia and Janssen Biologics.

Anish Suri, Ph.D. Chief Scientific Officer

Dr. Suri serves as the President and Chief Scientific Officer at Cue Biopharma Inc. He previously held the position of Senior Vice President and Chief Scientific Officer at the company and served as an Assistant Professor of Pathology & Immunology at Washington University.

Colin Sandercock, M.S.E., J.D. Senior Vice President and General Counsel

Mr. Sandercock has over 30 years of experience providing legal counsel to life sciences companies on a wide range of matters, including domestic and international patent litigation, compliance, procurement, and licensing. Before joining Cue Biopharma, he was a Partner at Perkins Coie, a position he held since 2009.

Daniel Baker, M.D. Interim Chief Development Officer

Dr. Baker is the Interim Chief Development Officer at Cue Biopharma.

Here are the key risks to Cue Biopharma's business:

1. Financial Health and Going Concern: Cue Biopharma is a clinical-stage biopharmaceutical company with a history of significant operating losses and negative cash flows, and it has not yet generated commercial revenue from product sales. The company's recurring losses raise substantial doubt about its ability to continue as a going concern, as indicated by its Altman Z-Score which places it in a distress zone. Its survival is heavily dependent on its ability to secure consistent, non-dilutive funding, often through strategic partnerships or future capital raises, to cover its significant research and development expenses and sustain operations.
2. Clinical Trial and Regulatory Risk: The success of Cue Biopharma is fundamentally reliant on the successful development, clinical testing, and regulatory approval of its drug candidates, such as CUE-101 and CUE-401. As a company with only a few drug candidates currently in clinical trials, any setbacks, delays, or failures in these trials, or an inability to obtain necessary regulatory approvals from agencies like the FDA, would have a material adverse impact on its business, financial condition, and future growth prospects.
3. Dependence on Collaborations and External Funding: Cue Biopharma's revenue stream is primarily derived from collaboration agreements with third parties, rather than product sales. The continuation and success of these partnerships are critical, as the company depends on upfront payments and milestone recognition from these agreements to fund its operations and pipeline development. The termination or reduction of any key collaboration agreements could significantly impact its financial stability and ability to advance its drug candidates.

Cue Biopharma's main products target several significant addressable markets globally:

• CUE-101 (targeting Human Papillomavirus (HPV)-driven cancers, specifically HPV16-positive Head and Neck Squamous Cell Carcinoma (HNSCC)): The global HPV associated disorders treatment market was valued at USD 19.6 billion in 2023 and is projected to grow to USD 30.1 billion by 2032. More specifically, the HPV16-positive HNSCC market was approximately USD 810 million in 2024 across the 7MM (United States, EU4: Germany, France, Italy, Spain, United Kingdom, and Japan). Additionally, the global cervical cancer treatment market is projected to grow from an estimated US$8.6 billion in 2024 to US$11.8 billion by 2030.
• CUE-103 (targeting KRAS G12V mutation, including colorectal carcinoma, lung cancer, and pancreatic cancer):
  • Colorectal Cancer: The global colorectal cancer market size was evaluated at USD 13 billion in 2023 and is slated to reach USD 20 billion by the end of 2032. The global metastatic colorectal cancer market is projected to reach USD 19.06 billion by 2035, from USD 6.78 billion in 2024.
  • Lung Cancer: The global lung cancer market is estimated to be valued at USD 31.72 billion in 2026 and is expected to reach USD 73.70 billion by 2033.
  • Pancreatic Cancer: The global pancreatic cancer treatment market size was estimated at USD 2.92 billion in 2024 and is projected to reach USD 5.84 billion by 2030. Another estimate indicates the global pancreatic cancer industry will increase from USD 2.65 billion in 2024 to USD 9.57 billion by 2034.
• CUE-200 (focusing on T cell exhaustion associated with chronic infections): The global infectious disease therapeutics market size was estimated at USD 243,409.1 million in 2024 and is projected to reach USD 283,908.2 million by 2030.
• CUE-300 and CUE-400 (targeting various autoimmune diseases): The global autoimmune disease therapeutics market size was worth around USD 123.96 billion in 2024 and is predicted to grow to around USD 249.71 billion by 2034.

Here are 3-5 expected drivers of future revenue growth for Cue Biopharma (CUE) over the next 2-3 years:

1. Milestone and Upfront Payments from Strategic Collaborations: Cue Biopharma's revenue primarily stems from collaboration agreements as it is a clinical-stage biopharmaceutical company without commercial product sales. Significant drivers include upfront payments and potential milestone payments from existing and future partnerships. For instance, the company has a collaboration and license agreement with Boehringer Ingelheim for CUE-501, which included an upfront payment of $12 million in April 2025 and potential milestone payments totaling approximately $345 million. Another strategic collaboration with ImmunoScape, announced in November 2025, provides for $15 million in upfront payments ($10 million in Q4 2025 and $5 million in November 2026) and a 40% equity stake in ImmunoScape. The successful execution of these agreements and the initiation of new collaborations for its Immuno-STAT platform, especially in the autoimmune space, are critical for revenue growth.
2. Advancement of Clinical Pipeline Candidates: Progress in the clinical development of its lead drug candidates is a key driver for future revenue. CUE-101, a fusion protein biologic in Phase 1b clinical trials for HPV-driven cancers, has shown promising clinical data, including a confirmed 50% Overall Response Rate (ORR) in combination with pembrolizumab and a median Overall Survival (mOS) of 32.7 months. Further advancement of CUE-101 towards later-stage trials and potential regulatory approval, as well as the progression of other oncology candidates like CUE-102 and CUE-103, could lead to increased partnership interest or eventual commercialization revenue.
3. Development of Autoimmune Disease Programs: Cue Biopharma has strategically pivoted to prioritize its autoimmune disease programs, with CUE-401 being a lead candidate aiming to address high unmet medical needs. Advancing CUE-401 towards clinical trials is a significant focus, and promising preclinical data for CUE-401 was presented in March 2026. The company's CUE-500 series, including CUE-501, also targets autoimmune and inflammatory diseases and is part of the Boehringer Ingelheim collaboration. Successful development and potential partnering of these autoimmune assets represent a substantial long-term revenue opportunity.
4. Potential Royalty Streams from Commercialized Products: While not expected in the immediate 2-3 years given the clinical-stage nature of its pipeline, the long-term revenue growth could be driven by royalty payments on net sales if any of its partnered drug candidates, such as CUE-501 or products developed through the ImmunoScape collaboration, successfully reach commercialization.

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