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 pioneering clinical-stage biopharmaceutical company located in Boston, Massachusetts. The company focuses on developing a novel class of injectable biologics designed to selectively engage and modulate disease-specific T cells directly within the patient's body. Cue Biopharma’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells), aims to harness the body’s intrinsic immune system as T cell engagers, minimizing the need for ex vivo manipulation and broad systemic immune modulation.
The company's leading clinical programs include CUE-101 and CUE-102. CUE-101 is being evaluated for the treatment of recurrent/metastatic HPV16+ head and neck squamous cell carcinoma both as a monotherapy and in combination with pembrolizumab (KEYTRUDA®). Recent data from Phase 1 trials have shown promising results, including prolonged overall survival and enhanced clinical activity when combined with pembrolizumab.
CUE-102 targets Wilms' Tumor 1 (WT1)-expressing cancers such as colorectal, gastric, and pancreatic cancers. Early Phase 1 trial data for CUE-102 has demonstrated expansion of WT1-specific T cells and favorable tolerability, pointing to potential therapeutic benefits for cancers resistant to traditional treatments.
Additionally, Cue Biopharma is advancing its preclinical program CUE-401 for autoimmune and inflammatory diseases in collaboration with Ono Pharmaceutical. This program aims to redirect virus-specific T cells to deplete B cells in autoimmune conditions.
Financially, Cue Biopharma reported increased collaboration revenue due to its strategic agreement with Ono Pharmaceutical. Despite higher research and development expenses, the company maintains a strong cash position, with approximately $41 million in cash and equivalents expected to fund operations into the first quarter of 2025. The management team, led by CEO Daniel Passeri, continues to focus on strategic corporate objectives, including potential registrational trials for CUE-101 and advancing other therapeutic candidates.
With an experienced leadership and independent Board of Directors, Cue Biopharma is well-positioned to make significant strides in the fields of oncology and autoimmune disease treatment, aiming to deliver transformative therapies for patients while creating value for its shareholders.
Cue Biopharma reported Q3 2024 financial results and clinical progress. The company's Phase 1 trial of CUE-101 with KEYTRUDA showed 46% objective response rate and 91.3% 12-month survival in HPV+ head and neck cancer patients. CUE-102 demonstrated 67% disease control rate in pancreatic cancer. Financially, collaboration revenue increased to $3.3M from $2.1M year-over-year, while R&D expenses decreased to $9.4M from $9.9M. The company ended Q3 with $32.4M in cash, expected to fund operations into Q4 2025.
Cue Biopharma (Nasdaq: CUE) announced key organizational changes with Daniel Baker, M.D., joining as interim chief development officer (CDO) effective November 25, 2024. Dr. Anish Suri will transition from president & chief scientific officer to principal research and immunology advisor. Dr. Baker brings over 20 years of pharmaceutical industry experience, notably serving as Vice President of Immunology R&D at Johnson & Johnson, where he oversaw multiple successful drug developments leading to 15+ regulatory approvals. The transition aims to enhance the company's pipeline development in oncology and autoimmunity.
Cue Biopharma (Nasdaq: CUE) announced its participation in a fireside chat at the Stifel 2024 Healthcare Conference in New York, scheduled for November 18-19, 2024. The company will present updates on its oncology and autoimmune disease programs, including recent data from Phase 1 clinical trials of CUE-101 and CUE-102 previously presented at SITC 2024.
CEO Daniel Passeri will lead the presentation on Tuesday, November 19, from 1:15-1:45 p.m. EST. The fireside chat will be accessible via webcast and archived for 30 days on the company's website.
Cue Biopharma presented updated Phase 1 trial data for CUE-101 and CUE-102 at SITC 2024. CUE-101 combined with KEYTRUDA showed impressive results in head and neck cancer patients, achieving a 46% objective response rate and 91.3% 12-month overall survival. The median overall survival reached 21.8 months, significantly higher than historical data. For CUE-102, results showed a 67% disease control rate in late-stage pancreatic cancer patients, including a partial response with 40% tumor reduction. Both treatments demonstrated favorable safety profiles with no significant toxicity concerns.
Cue Biopharma (Nasdaq: CUE) announced two presentations at the Society for Immunotherapy of Cancer's 39th Annual Meeting (SITC 2024) in Houston, Texas, from November 6-10, 2024. The presentations will focus on their clinical assets CUE-101 and CUE-102, part of the CUE-100 series.
An oral presentation by Dr. Christine Chung will discuss a phase 1 study of CUE-101 as monotherapy and in combination with pembrolizumab for HPV16+ head and neck squamous cell cancer. A poster presentation by Dr. Dae Won Kim will cover a phase 1 trial of CUE-102 for WT1-positive recurrent/metastatic cancers in HLA-A*0201 positive patients.
The oral presentation is scheduled for November 8, 2024, and the poster will be displayed on November 9, 2024. Both presentations will be available as virtual e-posters from November 7, 2024, to January 7, 2025, and on the company's website from November 8, 2024.
Cue Biopharma (Nasdaq: CUE) has announced the pricing of a $12.0 million public offering. The offering includes 11,564,401 shares of common stock with warrants to purchase 2,891,100 additional shares, and pre-funded warrants to purchase 12,435,599 shares with warrants for 3,108,900 more shares. Each common stock share and warrant combination is priced at $0.50, while the pre-funded warrant and common stock warrant combination is priced at $0.499.
The offering is expected to close around September 30, 2024. Oppenheimer & Co. Inc. is the sole book-running manager, with Newbridge Securities as co-manager. The securities are being offered under a shelf registration statement filed with the SEC. This announcement does not constitute an offer to sell or a solicitation of an offer to buy these securities.
Cue Biopharma (Nasdaq: CUE), a clinical-stage biopharmaceutical company, has announced a proposed public offering of common stock shares and accompanying warrants. The offering includes the option for pre-funded warrants to purchase common stock. Oppenheimer & Co is acting as the sole book-running manager, with Newbridge Securities as co-manager.
The offering is subject to market conditions, and details regarding size and terms are not yet finalized. A shelf registration statement for this offering has been filed with the SEC and declared effective. The company will make the offering available through a prospectus supplement and accompanying prospectus.
Cue Biopharma (Nasdaq: CUE) has appointed Lucinda Warren as Chief Business Officer (CBO). With over 30 years of experience in the pharmaceutical and biotechnology sectors, Warren brings extensive expertise in strategic transactions, portfolio optimization, and alliance management. Her appointment follows Cue Biopharma's recent business restructuring and autoimmune program prioritization.
Warren's role will be important in advancing the company's core corporate objectives, particularly in aligning with third-party partnerships and collaborations to develop their platform of potential breakthrough immunotherapies. Her background includes significant roles at Johnson & Johnson and Janssen, where she was responsible for end-to-end business development, including licensing, mergers and acquisitions, and alliance management.
Cue Biopharma (Nasdaq: CUE) is set to present at The Promise of Interleukin-2 Therapy Conference in Paris, France, from September 4-7, 2024. Two key presentations are scheduled:
1. On September 6, Dr. Steven Quayle will present preclinical data on CUE-401, a novel bispecific fusion protein that induces and expands regulatory T cells through co-delivery of IL-2 and TGF-β.
2. On September 7, Dr. Matteo Levisetti will discuss the clinical safety and efficacy of the company's lead oncology programs CUE-101 and CUE-102, which selectively target IL-2 to tumor-specific T cells for enhanced efficacy and safety profiles.
These presentations highlight Cue Biopharma's innovative approach in developing therapeutic biologics to modulate disease-specific T cells.
Cue Biopharma (Nasdaq: CUE) reported Q2 2024 financial results and recent business highlights. Key points include:
1. CUE-101 showed promising results in HPV+ R/M HNSCC, with 46% ORR in 1L therapy and 20.8 months mOS in 2L+ monotherapy.
2. CUE-102 demonstrated dose-dependent T cell activation and anti-tumor activity in refractory metastatic cancers.
3. Q2 2024 collaboration revenue increased to $2.7 million from $1.4 million in Q2 2023.
4. R&D expenses decreased to $9.5 million in Q2 2024 from $10.7 million in Q2 2023.
5. Cash and cash equivalents were $30.0 million as of June 30, 2024, expected to fund operations through Q2 2025.
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