Core Insights - Cue Biopharma presented promising clinical data for its lead oncology asset CUE-101 in combination with KEYTRUDA® for treating HPV+ recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients, showing an objective response rate (ORR) of 46% and a 12-month overall survival (OS) of 91.3% [1][3] - The company also reported a 67% overall disease control rate (DCR) for its second clinical asset CUE-102 in late-stage pancreatic cancer patients, indicating significant anti-tumor activity [1][5] CUE-101 Clinical Trial Data - CUE-101 demonstrated an ORR of 46% and a DCR of 75% in first-line HPV+ R/M HNSCC patients, significantly outperforming the historical ORR of 19% with pembrolizumab alone [3] - The median overall survival (mOS) for patients treated with CUE-101 was 21.8 months, compared to 12.3 months in historical trials [4] - In patients with low PD-L1 expression (CPS 1-19), the ORR reached 50% [1][3] CUE-102 Clinical Trial Data - CUE-102 showed a 67% overall DCR in late-stage pancreatic cancer patients, including an unconfirmed partial response with a 40% decrease in tumor burden [1][5] - Evidence of selective expansion of WT1-specific T cells was observed, with no dose-limiting toxicities reported during the trial [6][10] Mechanism of Action - The CUE-100 series, including CUE-101 and CUE-102, utilizes a novel mechanism to selectively engage and modulate disease-specific T cells, enhancing the immune response against tumors [8][11] - CUE-101 is designed to activate HPV16 tumor-specific T cells, while CUE-102 targets WT1-specific T cells, both aiming to improve patient outcomes in various cancers [9][10] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a new class of therapeutic biologics to modulate T cells for cancer and autoimmune diseases [11][12] - The company’s proprietary Immuno-STAT platform aims to harness the body's immune system while minimizing adverse effects associated with traditional therapies [11]

Core Viewpoint - Cue Biopharma, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $12.0 million before expenses [1]. Group 1: Offering Details - The offering includes 11,564,401 shares of common stock and warrants for 2,891,100 shares, as well as pre-funded warrants for 12,435,599 shares and accompanying warrants for 3,108,900 shares [1]. - The combined public offering price for each common stock and warrant is $0.50, while the pre-funded warrants are priced at $0.499 [1]. - The offering is expected to close around September 30, 2024, pending customary closing conditions [1]. Group 2: Management and Structure - Oppenheimer & Co. Inc. is the sole book-running manager, with Newbridge Securities Corporation acting as co-manager for the offering [2]. - Cue Biopharma is led by an experienced management team and independent Board of Directors with expertise in immunology and immuno-oncology [6]. Group 3: Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of injectable biologics to engage and modulate disease-specific T cells [5]. - The company's proprietary platform, Immuno-STAT™, aims to harness the immune system's potential without broad systemic immune modulation [5].

Core Viewpoint - Cue Biopharma, Inc. is initiating an underwritten public offering of its common stock and accompanying warrants, subject to market conditions and uncertainties regarding the offering's completion and terms [1] Group 1: Offering Details - The public offering includes shares of common stock or pre-funded warrants to purchase common stock, along with accompanying warrants [1] - Oppenheimer & Co. is the sole book-running manager, while Newbridge Securities Corporation is acting as co-manager for the offering [2] - A shelf registration statement related to the offering was filed with the SEC on May 9, 2023, and declared effective on May 26, 2023 [3] Group 2: Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of injectable biologics that selectively engage and modulate disease-specific T cells [5] - The company's proprietary platform, Immuno-STAT™, aims to harness the immune system's potential without broad systemic immune modulation [5] - The company is headquartered in Boston, Massachusetts, and is led by a management team with expertise in immunology and immuno-oncology [6]

Core Insights - Cue Biopharma, Inc. has appointed Lucinda Warren as Chief Business Officer to enhance corporate development initiatives following a recent business restructuring and prioritization of autoimmune programs [1][2][3] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of injectable biologics that selectively engage and modulate disease-specific T cells [4] - The company's proprietary platform, Immuno-STAT™, aims to harness the body's immune system for targeted therapeutic effects without broad systemic immune modulation [4] Leadership and Experience - Lucinda Warren brings over 30 years of experience in the pharmaceutical and biotechnology sectors, having held significant roles at Johnson & Johnson and Janssen [2][3] - Her most recent position was Vice President of Business Development for Neuroscience and Japan Region at Johnson & Johnson, where she managed end-to-end business development including licensing and mergers [3] - Warren's leadership has been pivotal in optimizing resources and fostering high-performing teams, contributing to successful strategic transactions [3] Strategic Focus - The company aims to align with third-party partnerships and collaborations to develop its immunotherapy platform, with a commitment to maximizing value for shareholders and patients [3] - Warren's appointment is seen as a strategic move to enhance the company's ability to capitalize on opportunities in a timely manner [3]

Cue Biopharma, Inc. (NASDAQ:CUE) Q2 2024 Earnings Conference Call August 19, 2024 4:30 PM ET Company Participants Daniel Passeri - CEO Anish Suri - President & Chief Scientific Officer Matteo Levisetti - Chief Medical Officer Conference Call Participants Stephen Willey - Stifel Ren Benjamin - Citizens JMP Maury Raycroft - Jefferies Leland Gershell - Oppenheimer Edward Tenthoff - Piper Sandler Operator Good day, and welcome to the Cue Biopharma Second Quarter 2024 Earnings Call. All participants will be in a ...

Cue Biopharma, Inc. Q2 Earnings & Business Update Nasdaq: CUE August 19, 2024 Forward-Looking Statements Disclaimer This presentation has been prepared by Cue Biopharma, Inc. ("we," "us," "our," "Cue" or the "Company") and is made for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities, nor shall there be any sale of any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or ...

BOSTON, Aug. 19, 2024 (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, provided a business and financial update for the second quarter 2024. Recent Business Highlights Delivered oral presentation on updated data from ongoing Phase 1(b) trial of CUE-101 as a first line (1L) therapy in human papillomavirus positive (HPV+) recurrent/metastatic head and ...

Cue Biopharma, Inc. (CUE) came out with a quarterly loss of $0.20 per share versus the Zacks Consensus Estimate of a loss of $0.29. This compares to loss of $0.29 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 31.03%. A quarter ago, it was expected that this company would post a loss of $0.30 per share when it actually produced a loss of $0.25, delivering a surprise of 16.67%. Over the last four quarters, the company has sur ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share CUE Nasdaq Capital Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commissio ...

BOSTON, June 03, 2024 (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, today announced that it will participate in two investor conferences this June, the Jefferies Global Healthcare Conference, to be held in New York, NY, June 4-6 and the Oppenheimer Novel Targets and Immunology Summit, to be held in New York, NY on June 24. Cue Biopharma will discus ...