Cue Biopharma Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights

Cue Biopharma, Inc.

Mon, March 16, 2026 at 4:05 PM EDT 9 min read

• Advanced research and development of CUE-401 for IND (Investigational New Drug) readiness –
  CUE-401 is the Company’s lead asset for the treatment of autoimmune and inflammatory diseases

• Appointed industry veteran Lucinda Warren as Chief Financial and Business Officer

• Raised net proceeds of $10.2M through an underwritten public offering

• Announced strategic collaboration and license agreement with ImmunoScape to develop breakthrough cell therapy approach for solid tumors – Entitled to receive upfront payments totaling $15M

BOSTON, March 16, 2026 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune and inflammatory diseases, today reported fourth quarter and full year 2025 financial results.

“During the fourth quarter and throughout the full year 2025, the Company successfully met its strategic development goals and objectives that demonstrated significant progress towards establishing potential first-in-class and best-in-class assets for patients suffering with autoimmune diseases,” said Usman Azam, M.D., president and chief executive officer of Cue Biopharma. “With these strategic deliverables and continued progress to date, we believe we are well positioned to further advance our differentiating Immuno-STAT® platform and lead autoimmune asset, CUE-401, toward the clinic to address major unmet needs in autoimmune disease treatment.”

Business Highlights

• Advanced research and development of CUE-401 for IND (Investigational New Drug) readiness

  • Conducted toxicology and pharmacology studies and announced preclinical safety and tolerability data

    • In two non-GLP studies, CUE-401 was well tolerated with no adverse events observed

    • Proof-of concept studies reinforce promising preclinical profile and therapeutic potential of CUE-401

  • Presented in vivo and in vitro data that demonstrate the therapeutic potential of CUE-401 to restore immune balance for the treatment of autoimmune and inflammatory diseases at the World Immune Regulation Meeting (WIRM) held March 11-14, 2026

• Announced strategic collaboration and license agreement with ImmunoScape to develop breakthrough cell therapy approach for solid tumors

  • Entitled to upfront payments totaling $15 million. Of these payments, received $9.5 million, net of withholding taxes in the fourth quarter of 2025, and entitled to receive an additional $5 million in November 2026

  • Received a 40% equity stake in ImmunoScape, and the Company is eligible for high-single digit royalties

• Company plans to announce Virtual R&D Day event highlighting CUE-401, the company’s lead autoimmune asset, within the next couple of weeks. CUE-401 is designed to act mechanistically both as a regulator of proinflammatory mechanisms and as a master switch for regulatory T cell (Treg) differentiation to induce tolerance.