Cue Biopharma Reports Third Quarter 2025 Financial Results and Recent Business Highlights

Announced strategic collaboration and license agreement with ImmunoScape to develop breakthrough cell therapy approach for solid tumors – Company is entitled to receive upfront payments totaling $15M Announced strategic transition in leadership to further enable next stage of growth with disruptive autoimmune therapeutic candidates, most notably CUE-401, the Company's lead autoimmune asset BOSTON, Nov. 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 third quarter 2025. “During the third quarter of 2025 and early in the fourth quarter, the Company made tremendous progress from having successfully implemented a plan of optionality and laying the necessary groundwork for future growth,” said Usman Azam, M.D.

GlobeNewsWire • Nov 12, 2025

Cue Biopharma, Inc. (CUE) Reports Q3 Loss, Lags Revenue Estimates

Cue Biopharma, Inc. (CUE) came out with a quarterly loss of $0.07 per share versus the Zacks Consensus Estimate of a loss of $0.1. This compares to a loss of $0.17 per share a year ago.

Zacks Investment Research • Nov 12, 2025

Cue Biopharma and ImmunoScape Announce Strategic Collaboration to Develop Breakthrough Cell Therapy Approach for Solid Tumors

Exclusive collaboration and license agreement focuses on advancing novel T cell therapy “Seed-and-Boost” approach exploiting the mechanism of the CUE-100 series of Immuno-STATs® Novel therapeutic approach is designed to enable in vivo expansion and activation of infused T cell receptor engineered T cells (TCR-Ts) to provide durability, tolerability and enhanced clinical benefit while reducing manufacturing complexity Compelling data generated in preclinical models of multiple solid tumors, including pancreatic and ovarian, demonstrates the clinical potential of this novel immunotherapy approach with IND-enabling studies on track for 2027 submission BOSTON and SINGAPORE, Nov. 06, 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, and ImmunoScape, Pte. Ltd, a biotechnology company developing next-generation T cell receptor (TCR)-based therapies in oncology, today announced that they have entered into a collaboration and license agreement to advance a novel in vivo approach to cell therapy for the treatment of solid tumors.

GlobeNewsWire • Nov 6, 2025

Cue Biopharma Announces Strategic Transition in Leadership to Further Enable Next Stage of Growth with Disruptive Autoimmune Therapeutic Candidates

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.

GlobeNewsWire • Sep 29, 2025

Cue Biopharma to Participate in Fireside Chat at the Cantor Global Healthcare Conference

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.

GlobeNewsWire • Aug 21, 2025

Cue Biopharma Announces Initiation of Investigator Sponsored Trial of CUE-102 in Recurrent Glioblastoma Multiforme

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.

GlobeNewsWire • Aug 13, 2025

Cue Biopharma Reports Second Quarter 2025 Financial Results and Recent Business Highlights

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.

GlobeNewsWire • Aug 12, 2025

Cue Biopharma, Inc. (CUE) Reports Q2 Loss, Tops Revenue Estimates

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.

Zacks Investment Research • Aug 12, 2025

Cue Biopharma Reports New Complete Response and Confirmed 50% Overall Response Rate in Ongoing Phase 1 Trial of CUE-101 and Pembrolizumab in Recurrent/Metastatic HPV+ Head and Neck Cancer

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.

GlobeNewsWire • Jul 16, 2025

Cue Biopharma Provides Update on Most Advanced Clinical Stage Asset, CUE-101, Presented by Dr. Dimitrios Colevas at the DAVA 4th Hawaii Global Summit on Thoracic Malignancies

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

GlobeNewsWire • Jul 1, 2025