Cue Biopharma (CUE) Q1 2026 earnings summary

Executive summary

• Lead asset CUE-221, a novel anti-IgE antibody, is in Phase 2 for allergic diseases with an exclusive license agreement signed in April 2026.

• CUE-401, a bifunctional IL-2 and TGF-B program for autoimmune disease, is IND-ready with Phase 1 planned by end of 2026.

• CUE-501 is partnered with Boehringer Ingelheim (BI) for B cell depletion in autoimmune diseases.

• Appointed Shao-Lee Lin, M.D., Ph.D., as President, CEO, and Board Director in April 2026 to drive clinical-stage growth.

• Substantial doubt exists about ability to continue as a going concern beyond Q1 2027 without additional capital.

Financial highlights

• Collaboration revenue for Q1 2026 was $5.7M, up from $0.4M in Q1 2025, mainly from the Boehringer Ingelheim collaboration.

• Net loss for Q1 2026 was $5.2M, a significant improvement from $12.3M loss in Q1 2025.

• Cash and cash equivalents at March 31, 2026 were $16.4M, with an additional $30M raised and $7.5M milestone received post-quarter.

• Operating expenses decreased to $11.0M in Q1 2026 from $12.7M in Q1 2025, mainly due to lower R&D costs.

• Research and development expenses decreased to $6.9M from $8.5M year-over-year.

Outlook and guidance

• Cash runway, including recent financing and BI milestone, expected to fund operations into Q1 2027.

• IND amendment for CUE-221 in food allergy planned for H2 2026; Phase 2b trial to follow pending China study results.

• Results from China Phase 2 study in Chronic Spontaneous Urticaria expected in H2 2026.

• IND submission for CUE-401 expected in H2 2026, with Phase 1 study initiation by year-end 2026.

• Additional capital will be needed to continue operations and development programs beyond this period.