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Cue Biopharma, Inc. (CUE) Reports Q3 Loss, Tops Revenue Estimates
ZACKS· 2024-11-14 23:25
Group 1 - Cue Biopharma, Inc. reported a quarterly loss of $0.17 per share, better than the Zacks Consensus Estimate of a loss of $0.20, and an improvement from a loss of $0.24 per share a year ago, representing an earnings surprise of 15% [1] - The company posted revenues of $3.34 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 205.22%, compared to year-ago revenues of $2.1 million [2] - Cue Biopharma shares have declined approximately 43.2% since the beginning of the year, contrasting with the S&P 500's gain of 25.5% [3] Group 2 - The earnings outlook for Cue Biopharma is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The estimate revisions trend for Cue Biopharma is currently favorable, leading to a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] - The current consensus EPS estimate for the upcoming quarter is -$0.16 on revenues of $6 million, and -$0.73 on revenues of $11.48 million for the current fiscal year [7] Group 3 - The Medical - Biomedical and Genetics industry, to which Cue Biopharma belongs, is currently ranked in the top 29% of over 250 Zacks industries, suggesting a positive outlook for stocks within this sector [8]
Cue Biopharma Reports Third Quarter 2024 Financial Results and Recent Business Highlights
GlobeNewswire News Room· 2024-11-14 21:05
BOSTON, Nov. 14, 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 for the treatment of cancer and autoimmune disease, today provided a business and financial update for the third quarter of 2024. Recent Business Highlights Presented positive updated data from the Phase 1 trials of CUE-101 and CUE-102 at the Society for Immunotherapy of Cancer’s 3 ...
Cue Biopharma(CUE) - 2024 Q3 - Quarterly Report
2024-11-14 21:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 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 SEPTEMBER 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 Commission file number: 001-38327 Cue Biopharma, Inc. (Exact name of registrant as specified in its charter) Delaware 47-3324577 (State or other jurisd ...
Cue Biopharma Announces Strategic Organizational Transition
GlobeNewswire News Room· 2024-11-14 13:00
Core Insights - Cue Biopharma announces the appointment of Daniel Baker, M.D., as interim chief development officer (CDO) effective November 25, 2024, while Anish Suri, Ph.D., transitions to principal research and immunology advisor [1][2] - The organizational changes aim to enhance the company's growth and focus on advancing its drug pipeline in oncology and autoimmunity [2][3] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics designed to selectively engage and modulate disease-specific T cells for cancer and autoimmune disease treatment [1][5] - The company's proprietary platform, Immuno-STAT™, aims to harness the body's immune system without broad systemic immune modulation [5] Leadership Experience - Dr. Daniel Baker brings over 20 years of drug development experience, including significant roles at Johnson & Johnson, where he oversaw numerous Phase I-III trials leading to over 15 regulatory approvals [2][3] - Dr. Baker's previous positions include CEO and founder of Kira Therapeutics and Executive Director at Galapagos Therapeutics [2] Strategic Focus - The company aims to leverage Dr. Baker's expertise in immunotherapeutics to enhance clinical development and registrational strategies [3][4] - The transition is expected to strengthen the company's mission to deliver novel immunotherapies to patients [3]
Cue Biopharma Presents Positive Updated Data from its Phase 1 Trials of CUE-101 and CUE-102 in Head and Neck Cancer and WT1 Positive Cancers at the SITC 39th Annual Meeting
GlobeNewswire News Room· 2024-11-08 18:30
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]
Cue Biopharma Announces Pricing of $12.0 Million Public Offering
GlobeNewswire News Room· 2024-09-27 03:26
BOSTON, Sept. 26, 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 the pricing of an underwritten public offering of (i) 11,564,401 shares of its common stock and accompanying common stock warrants to purchase an aggregate of 2,891,100 shares of common stock and, (ii) to certain investors in lieu of common stock, pre-funded warra ...
Cue Biopharma Announces Proposed Public Offering
GlobeNewswire News Room· 2024-09-26 20:27
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]
Cue Biopharma Appoints Industry Veteran Lucinda Warren as Chief Business Officer
GlobeNewswire News Room· 2024-09-09 12:00
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(CUE) - 2024 Q2 - Earnings Call Transcript
2024-08-20 00:17
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(CUE) - 2024 Q2 - Earnings Call Presentation
2024-08-19 22:47
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 ...