Cue Biopharma, Inc. (CUE) Cue Biopharma, Inc. is a clinical-stage biopharmaceutical enterprise focused on creating biological therapies. Its central objective is the precise manipulation of the human immune system to address a spectrum of severe conditions, such as various cancers, chronic infectious diseases, and autoimmune disorders. The company's leading investigational therapeutic is CUE-101, a specialized fusion protein biologic. This candidate is currently advancing through Phase 1b clinical trials, engineered to specifically identify and activate antigen-specific T cells involved in cancers originating from human papillomavirus. Beyond its flagship program, Cue Biopharma is also developing a range of other innovative platforms: CUE-102, another fusion protein biologic designed to stimulate specific T cells to combat cancer; CUE-103, an Immuno-STAT from the CUE-100 series, which is developed to target the KRAS G12V mutation relevant in diseases like colorectal, lung, and pancreatic cancers; CUE-200, which concentrates on cell surface receptors such as CD80 and/or 4-1BBL to counteract T cell exhaustion often seen in chronic infections; and the CUE-300 and CUE-400 frameworks, conceptual platforms aimed at treating diverse autoimmune conditions. Cue Biopharma maintains key strategic alliances, including collaborations with Merck Sharp & Dohme Corp. for the research and development of its unique biologics targeting autoimmune indications, with LG Chem Life Sciences for advancing Immuno-STATs in the field of oncology, and with the Albert Einstein College of Medicine. The company, founded in 2014, was initially known as Imagen Biopharma, Inc. before adopting its current name, Cue Biopharma, Inc., in October 2016. It is headquartered in Cambridge, Massachusetts.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Cue Biopharma, Inc. NASDAQ:CUE Healthcare · Biotechnology
Mkt Cap $151.61M
Vol 0
$ Vol 0
RVOL 0
Earnings 0
Press Release ● Critical ⚠ 5
Cue Biopharma Announces Positive Topline Results from CUE-221 Phase 2 Study in Chronic Spontaneous Urticaria
Cue Biopharma reported positive topline results from its Phase 2 trial of lead asset CUE-221 (UB-221) in chronic spontaneous urticaria, a 145-patient study run by Genesis Life Sciences in China with a 16-week treatment period.
At week 12, 54% of patients on the 4 mg/kg dose achieved complete resolution of hives (HSS7=0) versus 11% on placebo and 41% on omalizumab, with all dose levels meeting statistical significance; the key secondary endpoint (UAS7=0) hit significance at the highest dose at 46% versus 29% for omalizumab.
Durability appears differentiated: at week 28, 12 weeks after the last dose, 60% of 4 mg/kg patients maintained complete resolution versus 24% on omalizumab — a statistically significant post hoc delta of 36 points — with no treatment-related serious adverse events or hypersensitivity cases reported.
Management plans rapid initiation of a Phase 2b/3 study in CSU and a Phase 2 food-allergy study, with a conference call scheduled for September 21 at 8:00 a.m. EDT.
• 1mo ago AI analysis › Press Release ⚠ 2
Cue Biopharma Reports Second Quarter 2026 Financial Results and Recent Business Highlights
Cue Biopharma reported Q2 2026 revenue of $7.9 million, up from $3.0 million in the prior year, driven by a milestone payment from the Boehringer Ingelheim collaboration.
The company recorded a net loss of $153.1 million, largely due to one-time non-cash charges of approximately $63.1 million and significant expenses related to the CUE-221 license agreement.
With cash at $17.4 million at quarter-end, Cue subsequently closed a $50 million private placement to fund clinical development and submitted an IND for CUE-221, while appointing a new Chief Medical Officer and CFO.
• 2mo ago AI analysis › Press Release ⚠ 1
Cue Biopharma Announces Appointment of James M. Ahlers as Chief Financial Officer and CUE-221 Investigational New Drug Submission
Cue Biopharma appointed James M. Ahlers as its new Chief Financial Officer, bringing 25 years of financial leadership and capital markets expertise to the company.
The appointment comes at a pivotal time as the company recently submitted an IND for CUE-221 in food allergy and anticipates a Phase 2 data readout by the end of the quarter.
As an inducement for his employment, Mr. Ahlers received options to purchase 51,000 shares and 25,500 restricted stock units, both vesting over four years.
• 2mo ago AI analysis › Press Release ⚠ 2
Cue Biopharma Appoints Dominic Borie, M.D., Ph.D., as Chief Medical Officer and Head of Research & Development
Cue Biopharma appointed Dominic Borie, M.D., Ph.D., as Chief Medical Officer and Head of Research & Development, leveraging his two decades of experience at Amgen, Genentech and Kyverna.
The appointment aligns with upcoming catalysts, including Phase 2 CSU data readout for CUE-221 expected by the end of Q3 and the initiation of a Phase 1 trial for CUE-401 by the end of Q4.
Dr. Borie received inducement awards of 63,000 stock options and 31,500 restricted stock units, vesting over four years.
• 3mo ago AI analysis › Press Release ⚠ 1
Cue Biopharma Announces $50.0 Million Private Placement
Cue Biopharma secured approximately $50 million in gross proceeds through a private placement led by Cormorant Asset Management, selling 1.4 million shares at $33.21 per share and pre-funded warrants.
Net proceeds are intended to fund clinical development and general corporate purposes as the company advances its portfolio of immunological disorder therapies.
Management highlighted upcoming milestones, including Phase 2 data from Ascendant Health's CSU study in China expected by the end of Q3 2026.
• 3mo ago AI analysis › Press Release ⚠ 2
Cue Biopharma Announces Board Transition and Addition of New Directors with Continued Company Evolution
Cue Biopharma announced a board transition effective May 29, 2026, with four independent directors—Jill Broadfoot, Peter Kiener, Frank Morich, and Patrick Verheyen—resigning from the board.
The company simultaneously appointed Daniel Camardo, a former CEO with extensive commercial launch experience, and Viola Meehan, a former CFO with deep strategic finance expertise, to fill the vacancies.
Management stated the changes are intended to support the company’s evolution into a late-stage clinical organization, adding specific skills in commercial scaling and financial governance.
• 4mo ago AI analysis › Press Release
Cue Biopharma to Present at the 2026 Jefferies Global Healthcare Conference
Cue Biopharma announced that CEO Shao-Lee Lin will present at the Jefferies Global Healthcare Conference on June 3, 2026.
The presentation is scheduled for 3:10 p.m. EDT in New York City and will be available via live audio webcast.
The release includes standard boilerplate descriptions of the company's pipeline, including its lead anti-IgE antibody and CUE-401, but contains no new operational or financial data.
• 5mo ago AI analysis › Press Release ⚠ 3
Cue Biopharma Reports First Quarter 2026 Financial Results and Recent Strategic Developments
Cue Biopharma reported Q1 2026 revenue of $5.7 million, a massive increase from $0.4 million in the prior year, driven by a collaboration with Boehringer Ingelheim. The company narrowed its net loss to $5.2 million from $12.3 million, aided by lower R&D spend and a gain on lease termination.
The company appointed Shao-Lee Lin as President and CEO, bringing 25 years of immunology experience to lead the transition into a clinical-stage company. Lin highlighted that the recent financing extends the cash runway to support key clinical milestones for assets CUE-221 and CUE-401 in the second half of 2026.
Cue completed a $30 million private placement and received a $7.5 million milestone payment, bolstering its balance sheet. The financials reflect a 1-for-30 reverse stock split effective April 23, 2026, which restated share counts and per-share metrics.
• 5mo ago AI analysis › Press Release
Cue Biopharma Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Cue Biopharma granted inducement equity awards to seven new employees, including its newly appointed CEO, Shao-Lee Lin, as part of its 2026 Inducement Stock Incentive Plan.
Dr. Lin received a non-statutory stock option to purchase 655,074 shares at $30.42 per share and fully vested restricted stock units for 327,537 shares.
The other six employees received stock options for a total of 518,599 shares and fully vested restricted stock units for 327,534 shares, all in line with the company's standard vesting schedule.
• 5mo ago AI analysis › Press Release
Cue Biopharma Announces $30 Million Private Placement
Cue Biophama entered into a securities purchase agreement for a $30 million private placement with accredited investors.
The transaction involves the sale of pre-funded warrants for 2.7 million shares and accompanying warrants for 1.4 million shares at an effective price of $11.00 per unit.
Net proceeds are intended to advance the clinical pipeline, including the acquisition and development of Ascendant-221, and to support working capital.
• 6mo ago AI analysis › Press Release ● Major ⚠ 2
Cue Biopharma Expands Pipeline with Exclusive License from Ascendant Health Sciences Ltd. for Clinical-Stage Dual-Mechanism Anti-IgE Antibody
Cue Biopharma licensed the clinical-stage anti-IgE antibody Ascendant-221 from Ascendant Health Sciences, paying $15M upfront and committing up to $676.5M in milestones.
The deal grants Cue global rights excluding Greater China, with plans to launch a Phase 2b food allergy trial after Phase 2 data in chronic spontaneous urticaria arrives in 2H 2026.
This acquisition transforms Cue into a clinical-stage company with a robust immunology portfolio, complementing its existing CUE-401 and Immuno-STAT platform.
• 6mo ago AI analysis › Press Release ● Major ⚠ 1
Cue Biopharma Names Shao-Lee Lin M.D., Ph.D., CEO, President and Board Director to Lead Continued Growth and Transformation into a Clinical-Stage Company
Cue Biopharma appointed Shao-Lee Lin, M.D., Ph.D., as Chief Executive Officer, President and Director, succeeding interim CEO Lucinda Warren.
Dr. Lin brings over 25 years of experience, including founding ACELYRIN and leading it to an IPO, and held leadership roles at Horizon Therapeutics, AbbVie, and Amgen.
She highlighted the advancement of CUE-401 towards Phase 1 and the addition of an ongoing Phase 2 anti-IgE program, targeting a 2H2026 inflection point.
• 6mo ago AI analysis › Press Release ● Major ⚠ 2
Cue Biopharma Announces 1-for-30 Reverse Stock Split
Cue Biopharma will implement a 1-for-30 reverse stock split effective April 23, 2026, reducing outstanding shares from approximately 97.7 million to roughly 3.3 million.
The primary goal of the split is to increase the per-share price to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market.
Split-adjusted trading is expected to commence on April 24, 2026, under the existing ticker CUE with a new CUSIP number.
• 6mo ago AI analysis › Press Release
Cue Biopharma to Receive $7.5 Million Preclinical Milestone Payment from Boehringer Ingelheim Collaboration and License Agreement
globenewswire.com • 6mo ago Press Release
Cue Biopharma Announces CEO Transition
globenewswire.com • 7mo ago Press Release
Cue Biopharma to Host Virtual R&D Day Event on April 7, 2026
globenewswire.com • 7mo ago Press Release ● Major
Cue Biopharma Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights
globenewswire.com • 7mo ago Press Release
Cue Biopharma to Present New In vitro Data for CUE-401 at the 20th World Immune Regulation Meeting (WIRM) 2026
globenewswire.com • 7mo ago Press Release
Cue Biopharma Announces Preclinical Safety and Tolerability Data for CUE-401 for the Treatment of Autoimmune and Inflammatory Diseases
globenewswire.com • 8mo ago Press Release
Cue Biopharma Appoints Industry Veteran Lucinda Warren as Chief Financial and Business Officer
globenewswire.com • 8mo ago 
