Cue Biopharma Inc Stock Price, News & Analysis

Cue Biopharma (Nasdaq: CUE) and Boehringer Ingelheim have announced a strategic research collaboration and license agreement to develop CUE-501, a novel B cell depletion therapy for autoimmune diseases. The partnership focuses on developing a first-in-class bispecific compound that targets specific B cells through T cell mediated depletion.

The preclinical candidate molecule works by binding to B cell specific membrane proteins while engaging virus-specific memory killer T cells, potentially offering improved benefits and safety compared to existing B cell targeting approaches. Under the agreement terms, Cue Biopharma will receive:

• $12 million upfront payment plus research support
• Up to $345 million in potential milestone payments
• Royalty payments on net sales

This collaboration aims to expand Boehringer's autoimmune and inflammatory disease pipeline, targeting earlier treatment intervention and long-term disease control.

Cue Biopharma (Nasdaq: CUE) reported its Q4 and full year 2024 financial results. The company's collaboration revenue for Q4 2024 was $1.6 million, down from $1.8 million in Q4 2023. Full-year collaboration revenue increased to $9.3 million from $5.5 million in 2023, driven by the Ono Pharmaceutical partnership.

R&D expenses decreased to $7.2 million in Q4 2024 from $10.9 million in Q4 2023, while G&A expenses reduced to $4.0 million from $4.6 million. For the full year, R&D expenses were $36.3 million (down from $40.8 million) and G&A expenses were $14.6 million (down from $16.7 million).

The company appointed new leadership including Lucinda Warren as Chief Business Officer and Daniel Baker as Interim Chief Development Officer. Cue regained worldwide rights for CUE-401, their lead autoimmune program, and advanced CUE-501 development. Cash position stood at $22.5 million as of December 31, 2024.

Cue Biopharma (Nasdaq: CUE) has granted an inducement option award to its newly appointed interim chief development officer, Daniel Baker, M.D. The award consists of options to purchase 200,000 shares of company common stock at $1.06 per share, based on the closing price on November 25, 2024. The options will vest over two years in four equal installments, starting six months from the grant date, contingent on continued employment.

Cue Biopharma (Nasdaq: CUE), a clinical-stage biopharmaceutical company, announced its participation in a fireside discussion at the Piper Sandler 36th Annual Healthcare Conference in New York, NY, from December 3-5, 2024. The company will present updates on clinical and preclinical programs, along with strategic business and partnering objectives.

The presentation will be delivered by CEO Daniel Passeri on Wednesday, December 4, 2024, from 9:00 AM to 9:25 AM EST. A live webcast will be available, and the recording will be archived for 30 days on the company's website.

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.