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Cue Biopharma, Inc., a clinical-stage biopharmaceutical company, develops biologic drugs for the selective modulation of the human immune system to treat a range of cancers, chronic infectious diseases, and autoimmune disorders.
Its lead drug candidate is CUE-101, a fusion protein biologic that is in Phase 1b clinical trial designed to target and activate antigen-specific T cells for human papilloma virus-driven cancers. The company offers CUE-102, a fusion protein biologic to target and activate antigen-specific T cells to fight cancers; CUE-103 a CUE-100 series Immuno-STAT targeting the KRAS G12V mutation, including colorectal carcinoma, lung cancer, and pancreatic cancer; CUE-200 that focuses on cell surface receptors, including CD80 and/or 4-1BBL to address T cell exhaustion associated with chronic infections; and CUE-300 and CUE-400 framework to target various autoimmune diseases. Cue Biopharma, Inc. has collaboration agreements with Merck Sharp & Dohme Corp. for the research and development of its proprietary biologics that target various autoimmune disease indications; LG Chem Life Sciences for the development of Immuno-STATs focused on the field of oncology; and Albert Einstein College of Medicine. The company was formerly known as Imagen Biopharma, Inc. and changed its name to Cue Biopharma, Inc. in October 2016.
Cue Biopharma, Inc. was incorporated in 2014 and is headquartered in Cambridge, Massachusetts.
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The biopharmaceutical company is developing injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient's body.
Preclinical milestone for selection and approval of first compound for lead optimization has been achieved Further development validates the potential intended mechanistic effect of CUE-501 for T cell-mediated targeted depletion of specific B cells to address autoimmune and inflammatory diseases BOSTON, April 08, 2026 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage memory T cell subsets to deplete pathogenic B cells for the potential treatment of autoimmune and inflammatory diseases, today announced that it will receive a $7.5 million preclinical milestone payment under its collaboration and license agreement with Boehringer Ingelheim following Boehringer Ingelheim's selection and approval of its first compound for lead optimization. The Company expects to receive the payment in May 2026.
Cue Biopharma, Inc. (CUE) Discusses CUE-401 R&D Progress and Mechanism for Autoimmune and Inflammatory Diseases Transcript
BOSTON, March 27, 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, an industry veteran who has served as Cue Biopharma's chief financial and business officer since February 2026 and previously as Cue Biopharma's chief business officer from September 2024 until February 2026, has been appointed interim president and chief executive officer (CEO). Usman Azam has stepped down as president and CEO and as a director, effective March 26, 2026.
Virtual Event will feature Key Opinion Leaders (KOLs) Richard DiPaolo, PhD, and Jonathan Kay, MD, FACP, MACR
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.
BOSTON, March 09, 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 it will deliver a poster presentation on the company's lead asset, CUE-401, at the World Immune Regulation Meeting (WIRM) being held March 11-14, 2026 in Davos, Switzerland. The presentation will include new in vitro data that demonstrate the therapeutic potential of CUE-401 to restore immune balance for the treatment of autoimmune and inflammatory diseases.
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.
