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 pioneering targeted immunotherapies through its innovative Immuno-STAT platform. This page serves as the definitive source for official company announcements, research developments, and strategic updates.
Investors and industry observers will find curated press releases covering clinical trial progress, regulatory milestones, and partnership announcements. Our collection includes updates on CUE-100 series candidates for oncology applications and autoimmune disease programs, along with financial reporting and executive commentary.
All content is sourced directly from company filings and authorized communications, ensuring reliability for those monitoring advancements in T cell-modulating therapies. Key focus areas include phase 1/2 trial results, platform technology enhancements, and collaboration updates with leading research institutions.
Bookmark this page for streamlined access to Cue Biopharma's latest scientific achievements and corporate developments in the competitive immunotherapy landscape. Check regularly for real-time updates on this innovative biologics developer.
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.
Cue Biopharma (Nasdaq: CUE) announced updated clinical data for CUE-101, its lead therapeutic candidate, in combination with KEYTRUDA® for treating HPV+ head and neck squamous cell carcinoma (HNSCC). The Phase 1 trial demonstrated significant efficacy improvements compared to historical data.
Key results include an overall response rate (ORR) of 50% in treatment-naïve patients with CPS >1, and notably, the same ORR in patients with low CPS scores (1-19). This substantially exceeds the historical 19% ORR observed with pembrolizumab monotherapy in the KEYNOTE 048 trial.
The trial showed remarkable survival metrics, with a 12-month overall survival rate of 88% and a median overall survival of 32 months. These results represent a significant reduction in death risk (HR 0.23) compared to historical data. The company is now pursuing strategic alternatives, including potential partnering opportunities.
Cue Biopharma (Nasdaq: CUE) has received positive Pre-IND feedback from the FDA regarding CUE-401, their lead autoimmune asset. CUE-401 is a first-in-class bispecific fusion protein designed to induce and expand regulatory T cells (Tregs) through the combined activity of TGF-β and modified IL-2.
The FDA reviewed the company's first-in-human trial design, including dose escalation plans, proposed populations, and safety monitoring protocols. Based on this feedback, Cue Biopharma plans to proceed with an IND filing once final enabling studies are completed.
The company believes CUE-401's novel mechanism, combining TGF-β and IL-2 activities, could provide durable immune rebalancing and tolerance across multiple disease indications, potentially disrupting the current Treg-directed therapy landscape.
Cue Biopharma (NASDAQ: CUE) reported its Q1 2025 financial results and business highlights. The company secured a strategic collaboration with Boehringer Ingelheim for CUE-501, receiving a $12 million upfront payment with potential milestone payments of ~$345 million. The company also raised ~$20 million through a follow-on offering.
Q1 2025 financial results showed revenue of $0.4 million, down from $1.7 million in Q1 2024. R&D expenses decreased to $8.5 million from $10.2 million, while G&A expenses remained stable at $4.2 million. As of March 31, 2025, cash and equivalents stood at $13.1 million, with an additional $30 million received in April from the public offering and Boehringer Ingelheim partnership.
The company regained worldwide rights for CUE-401, its lead autoimmune program, and plans a virtual event on May 15, 2025, featuring key opinion leaders to discuss their immunology pipeline.
Cue Biopharma (Nasdaq: CUE) announced a virtual investor event scheduled for May 15, 2025, at 11:00 AM ET. The event will feature key opinion leaders Richard DiPaolo, PhD from Saint Louis University and Andrew Cope, MD, PhD from King's College London. They will discuss the company's biologics platform that selectively activates disease-relevant T cells, supported by Phase 1 clinical trial data from CUE-101 and CUE-102.
The presentation will include new preclinical proof-of-concept data for CUE-401, their lead candidate for autoimmune diseases, and an overview of the CUE-500 program, including CUE-501, which was recently partnered with Boehringer Ingelheim. Updates on the CUE-100 series clinical oncology programs will also be provided. The event will conclude with a Q&A session, and a webcast will be available for 30 days on the company's website.
Cue Biopharma (Nasdaq: CUE) announced its participation in a fireside chat at the Citizens Life Sciences Conference in New York on May 8, 2025. CEO Daniel Passeri will present from 11:00 AM to 11:25 AM EDT, discussing progress on the company's Immuno-STAT™ platform programs, including the CUE-100 series, CUE-401, and CUE-501. The presentation will highlight their recent partnership with Boehringer Ingelheim for CUE-501, focusing on T cell mediated targeted depletion of specific B cells for treating autoimmune and inflammatory diseases. A live webcast will be available, and the recording will be archived for 30 days on the company's website.
Cue Biopharma (Nasdaq: CUE) has announced the pricing of a public offering expected to raise approximately $20 million in gross proceeds. The offering includes:
- 13,530,780 shares of common stock with warrants to purchase 3,382,695 additional shares
- Pre-funded warrants to purchase 11,469,216 shares with warrants to purchase 2,867,304 additional shares
The common stock and accompanying warrants are priced at $0.79 per combined unit, while pre-funded warrants and accompanying warrants are priced at $0.789. Common stock warrants have a 5-year term with an exercise price of $0.79, while pre-funded warrants have a $0.001 exercise price. The offering is expected to close around April 16, 2025, with Oppenheimer & Co. Inc. acting as sole book-running manager.
Cue Biopharma (Nasdaq: CUE), a clinical-stage biopharmaceutical company, has announced plans for an underwritten public offering of common stock shares and accompanying warrants. The company, which develops therapeutic biologics for cancer and autoimmune disease treatment, will also offer pre-funded warrants to purchase common stock as an alternative.
The offering will be managed by Oppenheimer & Co. Inc. as the sole book-running manager, with Newbridge Securities serving as co-manager. The offering's completion, size, and terms are subject to market conditions and cannot be guaranteed.
The securities will be offered under a shelf registration statement on Form S-3 (File No. 333-271786) that was filed with the SEC on May 9, 2023, and became effective on May 26, 2023. A preliminary prospectus supplement will be filed with the SEC.
FAQ
What is the current stock price of Cue Biopharma (CUE)?
What is the market cap of Cue Biopharma (CUE)?
