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Cue Biopharma Announces CEO Transition
Globenewswire· 2026-03-27 20:05
Lucinda Warren Appointed Interim President and Chief Executive Officer – Usman Azam Steps DownBOSTON, 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 ...
Cue Biopharma to Host Virtual R&D Day Event on April 7, 2026
Globenewswire· 2026-03-26 12:00
Virtual Event will feature Key Opinion Leaders (KOLs) Richard DiPaolo, PhD, and Jonathan Kay, MD, FACP, MACR Cue Biopharma management and KOLs will discuss CUE-401, the company’s lead asset for the treatment of autoimmune and inflammatory diseases BOSTON, March 26, 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 a ...
Cue Biopharma Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights
Globenewswire· 2026-03-16 20:05
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 diseasesAppointed industry veteran Lucinda Warren as Chief Financial and Business OfficerRaised net proceeds of $10.2M through an underwritten public offeringAnnounced strategic collaboration and license agreement with ImmunoScape to develop breakthrough cell therapy approach for solid tumors – Entitled to receive upfront payments tot ...
Cue Biopharma(CUE) - 2025 Q4 - Annual Results
2026-03-16 20:00
Cue Biopharma Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights BOSTON, Mass., March 16, 2026-- 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 C ...
Cue Biopharma(CUE) - 2025 Q4 - Annual Report
2026-03-16 20:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission file number: 001-38327 Cue Biopharma, Inc. (Exact name of registrant as specified in its charter) | Delaware | 47- ...
Cue Biopharma to Present New In vitro Data for CUE-401 at the 20th World Immune Regulation Meeting (WIRM) 2026
Globenewswire· 2026-03-09 12:00
Core Viewpoint - Cue Biopharma, Inc. is advancing its lead asset CUE-401, a novel bifunctional therapeutic designed to treat autoimmune and inflammatory diseases, with a poster presentation scheduled at the World Immune Regulation Meeting in March 2026, showcasing new in vitro data that supports its therapeutic potential [1][2]. Group 1: CUE-401 Presentation Details - The poster presentation will be held on March 12, 2026, by Natasha M. Girgis, Director of Translational Pharmacology, focusing on CUE-401's ability to inhibit proinflammatory immune cells through TGF-beta [2]. - The session is categorized under Autoimmunity and Innate Immunity, highlighting the significance of CUE-401 in addressing autoimmune conditions [2]. Group 2: Mechanism of Action - CUE-401 operates through three mechanisms: direct regulation of proinflammatory pathways via TGF-beta, expansion of regulatory T cells (Tregs) through IL-2, and conversion of conventional CD4+ T cells into FOXP3+ induced Tregs [4]. - The therapeutic effects of CUE-401 include suppression of proinflammatory cytokines in CD4+ T effector memory cells and prevention of activated B cells from differentiating into plasma cells, thereby limiting antibody production [3]. Group 3: Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing injectable biologics that selectively engage and modulate disease-specific T cells, aiming to harness the body's immune system without broad systemic effects [5]. - The company utilizes its proprietary Immuno-STAT® platform to create therapeutics like CUE-401, which is designed to act as a master switch for Treg differentiation and immune tolerance [5].
Cue Biopharma Announces Preclinical Safety and Tolerability Data for CUE-401 for the Treatment of Autoimmune and Inflammatory Diseases
Globenewswire· 2026-02-17 13:00
Core Insights - Cue Biopharma, Inc. announced promising preclinical safety and tolerability data for CUE-401, its lead autoimmune asset, indicating no adverse events were observed in two non-GLP studies [1][2] - The company is optimistic about CUE-401's potential as a first-in-class bifunctional tolerogenic agent for autoimmune diseases and plans to file an investigational new drug (IND) application in the coming months [2] Study Design and Key Data Highlights - Two non-GLP studies were conducted in mice (n=24) and non-human primates (NHPs) (n=6) to assess the safety and tolerability of CUE-401 using a step-up dosing schedule [3] - CUE-401 was administered intravenously with escalating doses of 1 mg/kg, 3 mg/kg, and 10 mg/kg, all of which were well tolerated [6] - In the core study, animals received escalating doses of 0.1 mg/kg, 0.3 mg/kg, and 1 mg/kg, with no adverse observations reported [6] About CUE-401 - CUE-401 is a novel bifunctional therapeutic that combines a TGF-beta breathing-mask moiety with a clinically validated interleukin 2 (IL-2) mutein, designed to promote immune regulation and tolerance through multiple mechanisms [4][5] - The therapeutic aims to regulate proinflammatory mechanisms, expand existing Tregs, and convert conventional CD4+ T cells into FOXP3+ induced Tregs [4] About Cue Biopharma - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing injectable biologics to selectively engage and modulate disease-specific T cells [5] - The company's proprietary platform, Immuno-STAT™, aims to harness the body's immune system without broad systemic immune modulation [5]
Cue Biopharma Appoints Industry Veteran Lucinda Warren as Chief Financial and Business Officer
Globenewswire· 2026-02-12 13:00
Core Viewpoint - Cue Biopharma has appointed Lucinda Warren as Chief Financial and Business Officer, a strategic move aimed at driving business growth and advancing its lead autoimmune asset, CUE-401, toward clinical development [1][2]. Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of therapeutic biologics that selectively engage and modulate disease-specific T cells for treating autoimmune and inflammatory diseases [1][4]. - The company's proprietary platform, Immuno-STAT™, is designed to harness the body's immune system without the adverse effects of broad systemic immune modulation [4]. Leadership and Experience - Lucinda Warren has over 30 years of experience in the pharmaceutical and biotechnology sectors, previously serving as Vice President of Business Development at Johnson & Johnson [3]. - Warren's leadership has been pivotal in business development, including licensing, mergers and acquisitions, and alliance management [3]. Product Development - CUE-401, the lead autoimmune asset, is designed to regulate proinflammatory mechanisms and induce tolerance through a bifunctional molecule combining TGF-beta and interleukin 2 (IL-2) [4].
Biotech Sector Sees Broad After-Hours Gains Amid Quiet News Flow
RTTNews· 2026-01-23 04:42
Group 1 - Biotech stocks experienced significant gains in after-hours trading, with several companies showing strong percentage increases despite no new company-specific news [1][2][3][4] - Coherus Oncology, Inc. (CHRS) rose by 9.09% to close at $1.73, adding $0.14 in extended trading [1] - Sensei Biotherapeutics, Inc. (SNSE) surged 10.06% to finish at $12.47, gaining $1.14 [1] - Cue Biopharma, Inc. (CUE) advanced 9.37% to $0.40, increasing by $0.034 [1] - Alpha Tau Medical Ltd. (DRTS) increased by 3.35% to $7.41, up $0.24, with recent focus on new leadership [2] - Cingulate Inc. (CING) edged up 1.49% to close at $5.45, gaining $0.08 [3] - uniQure N.V. (QURE) posted a notable 9.96% jump to $24.95, adding $2.26 in after-hours trading [3] - IO Biotech, Inc. (IOBT) gained 4.19% to $0.50, up $0.020, while exploring strategic alternatives including mergers and asset sales [4]
Biotech Stocks Surge After Hours: IO Biotech Jumps 19%, Cue Biopharma And Cabaletta Bio Follow
RTTNews· 2026-01-22 04:12
Core Insights - Biotech and healthcare sectors experienced notable movements in after-hours trading, particularly among small-cap companies, with several posting significant gains [1] Company Summaries - IO Biotech, Inc. (IOBT) saw a surge of 19.36% to $0.25 after announcing plans to explore various strategic alternatives to maximize stockholder value, including potential mergers, asset sales, or liquidation. The company is also considering further reductions in workforce and operational costs [2] - Cue Biopharma, Inc. (CUE) advanced 10.67% to $0.42, with gains attributed to speculative trading despite no specific news from the company [3] - InfuSystem Holdings, Inc. (INFU) climbed 7.19% to $9.24, continuing a trend of strength in the medical services sector without any new corporate updates [3] - Cabaletta Bio, Inc. (CABA) added 7.68% to $2.52, with investors likely reacting to the company's January 12 update on its 2026 strategic priorities, including plans for the development of rese-cel and advancements in automated manufacturing [4] - Iterum Therapeutics plc (ITRM) gained 3.60% to $0.3284, driven by modest buying interest despite the absence of fresh news [5] - BioCardia, Inc. (BCDA) rose 3.91% to $1.33, attracting buyers in after-hours trading without any new updates [5]