Cue Biopharma, Inc.
Key statistics
from XBRL data in SEC filingsAI briefing
from the latest 10-K, 10-Q and 8-K eventsCue Biopharma is a clinical-stage biopharmaceutical company advancing a pipeline of immunology therapeutics, including a lead asset in Phase 2 for allergic diseases and a preclinical autoimmune candidate.
What they do
Cue Biopharma develops injectable therapeutics aimed at modulating the immune system. Its lead asset, CUE-221, is a humanized anti-IgE monoclonal antibody with a dual mechanism of action, currently in Phase 2 development for chronic spontaneous urticaria and intended for food allergy. The company also develops the Immuno-STAT platform, which includes CUE-401 for autoimmune diseases and partnered programs such as CUE-501 (licensed to Boehringer Ingelheim) and CUE-101/CUE-102 (licensed to ImmunoScape).
Revenue drivers
- Licensing and collaboration agreements — Revenue is primarily derived from upfront payments, milestones, and royalties under partnerships; the largest recent quarterly revenue of $21.9M (Q4 2025) likely reflects a significant deal or milestone.
- CUE-221 license to Ascendant Health — On April 30, 2026, the company licensed exclusive rights to develop and commercialize CUE-221 to Ascendant Health, which may include upfront and milestone payments.
- Boehringer Ingelheim collaboration — CUE-501 is under a collaboration and license agreement with BI; this program contributes to potential revenue through milestones and royalties.
- ImmunoScape licensing — CUE-101 and CUE-102 for oncology are licensed to ImmunoScape; this agreement provides potential revenue streams.
Recent performance
Annual revenue for 2025 was $27.5M, up from $9.3M in 2024, driven largely by a $21.9M quarter in Q4 2025. Net loss improved to $-26.6M in 2025 from $-40.7M in 2024, and operating cash flow improved to $-21.7M from $-36.3M. In Q1 2026, revenue was $5.7M and cash stood at $16.4M as of March 31, 2026.
Strategy
Cue Biopharma is prioritizing the clinical development of CUE-221, with plans to expand into food allergy and advance a global Phase 2b trial. The company is also advancing CUE-401 toward an IND submission and Phase 1 study by end of 2026. It relies on strategic partnerships, such as the Ascendant Health license for CUE-221, to fund development and broaden its pipeline. Management emphasizes the potential of its Immuno-STAT platform and CUE-221's differentiated mechanism to address unmet needs in autoimmune and allergic diseases.
Risks
- Clinical development risk — CUE-221 is in Phase 2 for CSU and has not yet been tested in food allergy; failure to show efficacy or safety could halt development.
- Dependence on partners — The company relies on partners like Ascendant Health, Boehringer Ingelheim, and ImmunoScape for development and commercialization; partner decisions could impact revenue and program progress.
- Limited cash runway — With $16.4M in cash as of Q1 2026 and ongoing operating losses, the company may require additional financing to fund operations and clinical trials.
- Regulatory and IND risk — CUE-401 is IND-ready but has not yet been submitted; delays or issues with FDA submission could affect the timeline.
Outlook
Management expects to submit an IND amendment for CUE-221 in food allergy in the second half of 2026 and to initiate a global Phase 2b trial after the Ascendant Phase 2 study. For CUE-401, they anticipate IND submission and Phase 1 start by the end of 2026. The company is also evaluating results from the CSU Phase 2 trial in China, expected in the second half of 2026.