Cue Biopharma

CUE

Market cap $61.2M

Usman Azam, M.D., is appointed President and Chief Executive Officer of Cue Biopharma, effective September 29, 2025 Daniel Passeri, Chief Executive Officer of Cue Biopharma, transitions to Strategic Advisor to provide ongoing support to the Company Cue Biopharma prioritizes autoimmune disease for next stage of growth with focus on advancing first-in-class tolerogenic biologic CUE-401 into the clinic BOSTON, Sept.

BOSTON, Aug. 21, 2025 (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 disease and cancer, today announced that it will participate in a fireside chat at the Cantor Global Healthcare Conference being held in New York, September 3-5, 2025.

BOSTON, Aug. 13, 2025 (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 disease and cancer, announced today the initiation of an investigator sponsored trial (IST) in rGBM at the DFCI with the first patient in the trial having been dosed with CUE-102. The trial (NCT06917885) is a Phase 1b, open-label study of adjuvant CUE-102, the Company's drug product candidate targeting Wilms' Tumor 1 protein (WT1) expressing cancers. The principal investigator of the Phase 1b trial, David A. Reardon, MD, is the Clinical Director of the Center for Neuro-Oncology at DFCI and a leader in the field of immunotherapy for the treatment of brain cancer. The goal of the study is to evaluate the tolerability and clinical activity of CUE-102 in patients with GBM at first recurrence.

Cue Biopharma, Inc. (CUE) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.13. This compares to a loss of $0.2 per share a year ago.

BOSTON, Aug. 12, 2025 (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 disease and cancer, today provided a business and financial update for the second quarter 2025.

Additional complete response (CR) observed in patient with multiple tumors Confirmed overall response rate (ORR) of 50% in patients with combined positive score (CPS) ≥1, including 50% ORR in patients with low CPS (1-19) 12-month overall survival of 88% and median overall survival (mOS) of 32 months BOSTON, July 16, 2025 (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 disease and cancer, today provided a clinical update on its most advanced asset, CUE-101, representative of the CUE-100 series. “We are excited to report an additional CR in a patient that had recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC) treated with CUE-101 in combination with pembrolizumab (KEYTRUDA®),” said Matteo Levisetti, chief medical officer at Cue Biopharma.

ORR of 50% in treatment-naïve patients with HPV+ R/M HNSCC 12-month landmark survival of 88% and mOS of 32 months

CUE-401, a first-in-class bispecific molecule designed to induce and expand Tregs in vivo through the co-activity of transforming TGF-β and a modified variant of IL-2 CUE-401, a first-in-class bispecific molecule designed to induce and expand Tregs in vivo through the co-activity of transforming TGF-β and a modified variant of IL-2

Cue Biopharma, Inc. (CUE) came out with a quarterly loss of $0.17 per share versus the Zacks Consensus Estimate of a loss of $0.14. This compares to loss of $0.25 per share a year ago.

Announced Boehringer Ingelheim strategic collaboration and license agreement for CUE-501, including an upfront payment of $12 million and ~$345 million in potential milestone payments