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Cue Biopharma, Inc. reports developments in clinical-stage immunology therapeutics and immune-modulating biologics. Company updates center on its Immuno-STAT platform, the autoimmune and inflammatory disease candidate CUE-401, a clinical-stage dual-mechanism anti-IgE antibody for allergic diseases, and collaboration activity involving B cell depletion programs such as CUE-501.
Recurring news also covers leadership changes, inducement equity awards, shareholder-approved capital actions, research presentations, milestone payments, licensing activity, and other corporate matters tied to Cue Biopharma's Nasdaq-listed common stock and clinical-stage operating model.
Cue Biopharma (Nasdaq: CUE) will present new preclinical data on lead candidate CUE-401 at IMMUNOLOGY2026 in Boston, April 15-19, 2026. The poster describes a bifunctional TGF-beta/IL-2 fusion that promotes antigen-specific FOXP3+ iTreg expansion, supporting potential to restore immune homeostasis.
Cue Biopharma (Nasdaq: CUE) will receive a $7.5 million preclinical milestone payment from its collaboration and license agreement with Boehringer Ingelheim after selection and approval of the first compound for lead optimization. The company expects the payment in May 2026. The multi-year collaboration could yield up to $337.5 million in additional milestone payments plus royalties and allows expansion into B cell-targeting bispecifics. Cue is advancing its lead autoimmune asset, CUE-401, toward the clinic while Boehringer Ingelheim will further develop CUE-501 under the agreement.
Cue Biopharma (Nasdaq: CUE) appointed Lucinda Warren as interim president and chief executive officer, effective March 27, 2026, after Usman Azam stepped down effective March 26, 2026. The board credited Ms. Warren with recent deal execution, including recovery of CUE-401 rights and collaborations with Boehringer Ingelheim and ImmunoScape.
Ms. Warren said she will focus on advancing CUE-401 into the clinic by the second half of 2026; she has 30+ years of global pharma and biotech experience and prior business development leadership at Johnson & Johnson.
Cue Biopharma (Nasdaq: CUE) will host a virtual R&D Day on April 7, 2026 at 10:00 AM EDT to present research on its lead asset, CUE-401, aimed at regulating proinflammatory mechanisms and promoting Treg differentiation for autoimmune and inflammatory diseases.
Key Opinion Leaders Richard DiPaolo, PhD, and Jonathan Kay, MD, will join company management for presentations, followed by a live Q&A. A live and archived webcast will be available on the company website and will be archived for 30 days.
Cue Biopharma (Nasdaq: CUE) reported Q4 and full-year 2025 results on March 16, 2026, highlighting a strategic collaboration with ImmunoScape, progress on lead autoimmune candidate CUE-401, and financing actions.
Key metrics: Q4 collaboration revenue of $21.9M, full-year collaboration revenue of $27.5M, cash and equivalents of $27.1M at year-end, net loss for 2025 of $26.6M, and net proceeds of $10.2M from a public offering. The company received $9.5M of a $15M upfront payment and obtained a 40% equity stake in ImmunoScape.
Cue Biopharma (Nasdaq: CUE) will present new in vitro data for lead asset CUE-401 at the World Immune Regulation Meeting (WIRM) in Davos, March 11–14, 2026.
The poster (Session P5) on March 12, 2026 highlights CUE-401’s TGF-β/IL-2 bifunctional design, reporting TGF-β–dependent suppression of proinflammatory cells, prevention of B cell plasma differentiation, NK cell modulation, and expansion of regulatory T cells.
Cue Biopharma (Nasdaq: CUE) reported preclinical safety and tolerability data for lead candidate CUE-401 on Feb 17, 2026. Two non-GLP studies in mice (n=24) and non-human primates (n=6) used step-up IV dosing; all core dose levels were well tolerated with no adverse events observed.
Follow-up NHP repeat dosing showed better tolerability at 1 mg/kg versus 3 mg/kg. Management said an IND filing for CUE-401 is planned in upcoming months.
Cue Biopharma (Nasdaq: CUE) appointed Lucinda Warren as Chief Financial and Business Officer, effective Feb 9, 2026. Ms. Warren has served as Cue’s chief business officer since Sept 2024 and brings 30+ years of global pharma and biotech experience.
Management expects Warren to help advance CUE-401, the company’s lead autoimmune asset, toward clinical development while overseeing financial and business strategy.
Cue Biopharma (Nasdaq: CUE) announced the pricing of an underwritten public offering to raise approximately $10 million in gross proceeds.
The offering consists of 35,714,286 shares of common stock (or pre-funded warrants in lieu) sold together with accompanying common stock warrants to purchase 17,857,143 shares at a combined public offering price of $0.28 per unit (pre-funded warrant units at $0.279). Each warrant has a $0.30 exercise price, is exercisable immediately, and expires five years from issuance.
The offering is expected to close on or about December 22, 2025, subject to customary closing conditions, and underwriters have a 30-day option to purchase up to an additional 5,357,140 shares and/or warrants to purchase 2,678,570 shares.
Cue Biopharma (Nasdaq: CUE) announced on December 18, 2025 that it is commencing an underwritten public offering of its common stock (or pre-funded warrants) together with accompanying warrants to purchase common stock.
The company said it will grant underwriters a 30-day option to purchase up to an additional 15% of the shares and/or warrants. The offering is subject to market and other conditions and will be made by a prospectus supplement to the company’s effective Form S-3 registration statement (File No. 333-271786).