Welcome to our dedicated page for Cue Biopharma news (Ticker: CUE), a resource for investors and traders seeking the latest updates and insights on Cue Biopharma stock.
Cue Biopharma, Inc. (Nasdaq: CUE) is a clinical-stage biopharmaceutical company headquartered in Boston, Massachusetts and focused on developing injectable biologics that selectively engage disease-specific T cells. News about Cue Biopharma often centers on its Immuno-STAT platform, clinical data from its CUE-100 series programs, and progress in autoimmune disease and oncology.
Investors and followers of CUE stock can use this page to review company press releases and third-party coverage related to Cue Biopharma’s pipeline. Typical updates include clinical trial readouts for CUE-101 in HPV16+ head and neck cancer and CUE-102 in WT1-expressing tumors, as well as developments around CUE-401, the company’s lead autoimmune asset designed to promote regulatory T cell–mediated tolerance.
News flow also highlights Cue Biopharma’s strategic collaborations and corporate milestones. Examples include agreements with Boehringer Ingelheim for CUE-501, a differentiated B cell depletion therapy for autoimmune and inflammatory diseases, and a collaboration and license agreement with ImmunoScape to advance a Seed-and-Boost cell therapy approach for solid tumors using the CUE-100 series. Financial updates, such as quarterly results, collaboration revenue disclosures and public equity offerings under the company’s shelf registration statement, are also common topics.
By following this CUE news feed, readers can track regulatory interactions, investigator-sponsored trials, leadership transitions, licensing deals and financing activities that may influence Cue Biopharma’s development trajectory. Bookmark this page to quickly access the latest headlines and historical announcements related to Cue Biopharma and its Immuno-STAT-based biologics.
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).
ImmunoScape (CUE) announced an exclusive in-licensing deal with Cue Biopharma (Nasdaq: CUE) on November 13, 2025 to combine Cue's clinical-stage Immuno-STAT® molecules with ImmunoScape’s precision TCR therapy in a novel "Seed-and-Boost" approach for solid tumors.
The program targets the WT1 antigen across multiple solid tumors and hematologic malignancies, has compelling preclinical efficacy, and plans IND-enabling studies to enable clinical trials by 2027. Leadership updates include board appointments of Usman Azam and Adrian Bot, and SAB appointment of Pamela Munster. The platform aims to enable in vivo expansion of tumor-targeting T cells while limiting systemic IL-2 toxicity.
Cue Biopharma (Nasdaq: CUE) reported Q3 2025 results and business highlights on November 12, 2025. Key items: a strategic collaboration and license with ImmunoScape including $15M upfront cash (scheduled $10M in Q4 2025, $5M in Nov 2026) plus a 40% equity stake; leadership transition naming Usman Azam CEO effective Sept 29; clinical update reporting a confirmed 50% ORR and new complete response in the Phase 1 CUE-101 + pembrolizumab trial, with 12‑month OS 88% and median OS 32.7 months.
Quarterly finance highlights: collaboration revenue $2.1M, R&D $4.8M (down from $9.4M), G&A $4.9M (up from $2.9M), net loss $7.45M, and cash and equivalents $11.7M as of Sept 30, 2025.
Cue Biopharma (Nasdaq: CUE) and ImmunoScape announced a collaboration and license to co-develop a novel “Seed-and-Boost” T cell therapy for solid tumors using Cue’s CUE-100 Immuno-STAT molecules paired with ImmunoScape’s proprietary TCRs.
Key terms: Cue is entitled to $15 million upfront ($10M in Q4 2025, $5M in Nov 2026) and a 40% equity stake in ImmunoScape plus eligible high-single-digit royalties. IND-enabling studies are on track for a 2027 IND submission. Preclinical data show activity in pancreatic and ovarian tumor models; CUE-100 Phase 1 datasets reported clinical activity without significant IL-2 toxicities.
Cue Biopharma (Nasdaq: CUE) announced a strategic leadership transition, appointing Dr. Usman "Oz" Azam as President and CEO effective September 29, 2025. Current CEO Daniel Passeri will transition to Strategic Advisor.
Dr. Azam brings over 25 years of drug development leadership experience, including notable roles at Inspirna, Empyrean Neuroscience, Tmunity Therapeutics, and Novartis, where he helped secure the first FDA approval for CAR-T cell therapy. The transition aligns with Cue Biopharma's strategic focus on autoimmune disease, particularly advancing their first-in-class tolerogenic biologic CUE-401, which aims to restore immune homeostasis and potentially revolutionize autoimmune disease treatment.
Cue Biopharma (Nasdaq: CUE), a clinical-stage biopharmaceutical company, will participate in a fireside chat at the Cantor Global Healthcare Conference in New York from September 3-5, 2025. The company's CEO, Daniel Passeri, will present on September 5, 2025, at 8:00 a.m. EDT.
During the presentation, the company will discuss updates on their Immuno-STAT® platform and the development progress of CUE-401, their primary autoimmune treatment candidate. The presentation will be available via webcast and archived for 30 days on the company's website.
Cue Biopharma (Nasdaq: CUE) has initiated an investigator sponsored trial (IST) of CUE-102 for recurrent glioblastoma multiforme (rGBM) at Dana-Farber Cancer Institute. The Phase 1b open-label study has dosed its first patient, focusing on evaluating CUE-102's tolerability and clinical activity in GBM patients at first recurrence.
The trial, led by Dr. David A. Reardon, Clinical Director of DFCI's Center for Neuro-Oncology, targets Wilms' Tumor 1 protein (WT1) expressing cancers. CUE-102 is designed to activate WT1-specific T cells against glioblastoma, which typically presents challenges for standard immunotherapies due to its immunologically 'cold' tumor nature but exhibits high levels of WT1 protein.
[ "Initiation of new Phase 1b trial for CUE-102 in glioblastoma treatment", "Partnership with prestigious Dana-Farber Cancer Institute", "Trial targets WT1 protein which is highly expressed in glioblastoma", "Encouraging clinical data from CUE-100 series to date" ]Cue Biopharma (NASDAQ: CUE) reported Q2 2025 financial results and significant business developments. The company secured a strategic collaboration with Boehringer Ingelheim for CUE-501 development, receiving a $12 million upfront payment with potential milestone payments of ~$345 million.
Key highlights include positive FDA feedback on CUE-401's Pre-IND submission for autoimmune disease treatment, and impressive clinical results from the Phase 1 trial of CUE-101 in HPV+ head and neck cancer, showing a 50% overall response rate and 32-month median overall survival. The company strengthened its financial position by raising $20 million through a public offering.
Q2 2025 financial results showed collaboration revenue of $3.0 million, with reduced R&D expenses of $7.9 million compared to $9.5 million in Q2 2024. The company reported a net loss of $8.5 million, an improvement from the $10.2 million loss in Q2 2024.
Cue Biopharma (Nasdaq: CUE) reported significant progress in its Phase 1 trial of CUE-101 combined with pembrolizumab for treating recurrent/metastatic HPV+ head and neck cancer. The trial achieved a 50% overall response rate (ORR) in patients with Combined Positive Score (CPS) ≥1, including those with low CPS scores.
Key highlights include an additional complete response (CR) in a patient with multiple tumors, 12-month overall survival of 88% compared to 57% with pembrolizumab alone, and a median overall survival (mOS) of 32 months versus 12.3 months in the historical KEYNOTE-048 trial. The results demonstrate a significant reduction in death risk (HR 0.23) compared to historical data.
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