Cue Biopharma, Inc. (CUE)

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 BOSTON, Mass., Feb. 17, 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 announced preclinical safety and tolerability data that further supports the preclinical profile of CUE-401, the Company's lead autoimmune asset.

BOSTON, Feb. 12, 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 announced that Lucinda Warren, who has served as Cue Biopharma's chief business officer (CBO) since September 2024, has been appointed chief financial and business officer (CFBO) effective February 9, 2026. “The combination of Lucinda's financial and business acumen together with her extensive background makes the CFBO a key strategic partner in helping drive business growth and Company success, particularly as we aim to move CUE-401, our lead autoimmune asset, toward the clinic,” said Usman Azam, M.D.

Cue Biopharma, Inc. (NASDAQ: CUE - Get Free Report)'s stock price shot up 34.8% during mid-day trading on Friday. The company traded as high as $0.3324 and last traded at $0.3248. 7,086,842 shares changed hands during trading, an increase of 888% from the average session volume of 716,938 shares. The stock had previously closed at

BOSTON, Dec. 19, 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, today announced the pricing of an underwritten public offering of 35,714,286 shares of its common stock (or pre-funded warrants to purchase shares of common stock in lieu thereof) and accompanying common stock warrants to purchase an aggregate of 17,857,143 shares of common stock. Each share of common stock (or pre-funded warrant to purchase shares of common stock in lieu thereof) and accompanying common stock warrant are being sold together at a combined public offering price of $0.28 (or $0.279, in the case of pre-funded warrants to purchase shares of common stock). The aggregate gross proceeds of the offering are expected to be approximately $10 million, before deducting underwriting discounts and commissions and other offering expenses. Each common stock warrant will have an exercise price of $0.30 per share, will be exercisable immediately and will expire five years from the date of issuance. The offering is expected to close on or about December 22, 2025, subject to satisfaction of customary closing conditions. In addition, Cue Biopharma has granted the underwriters an option for a period of 30 days to purchase up to an additional 5,357,140 shares of its common stock and/or warrants to purchase up to 2,678,570 shares of common stock at the public offering price, less underwriting discounts and commissions. All of the securities are being offered by Cue Biopharma.

BOSTON, Dec. 18, 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, today announced that it is commencing an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and accompanying warrants to purchase shares of common stock. In addition, Cue Biopharma intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15% of the shares of its common stock and/or warrants to purchase shares of common stock offered in the public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the securities are being offered by Cue Biopharma.

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.

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.

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.

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