On August 12, 2025 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 autoimmune disease and cancer, reported a business and financial update for the second quarter 2025 (Press release, Cue Biopharma, AUG 12, 2025, View Source [SID1234655132]).
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"We made significant progress during the second quarter with highly encouraging clinical data from our ongoing Phase 1b clinical trial, supporting our belief that CUE-101, representative of the CUE-100 series, has the potential to establish a new standard of care for HPV+ HNSCC patients," said Daniel Passeri, chief executive officer of Cue Biopharma. "These maturing data, together with the continued advancements of our lead autoimmune programs, reinforces our commitment to provide patients with more effective and well tolerated therapies to treat serious disease."
Business Highlights
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Received FDA feedback on Pre-IND Briefing Document reinforcing Company’s intention to advance IND submission for CUE-401 to address unmet need in the treatment of autoimmune disease.
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Announced strategic research collaboration and license agreement with Boehringer Ingelheim to develop and commercialize CUE-501, a differentiated B cell depletion therapy for autoimmune and inflammatory diseases.
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Upfront payment of $12 million and ~$345 million in potential milestone payments
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Raised approximately $20 million through a public offering.
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Hosted virtual investor event, Mobilizing the Immune System: Cue Biopharma’s Novel Biologics Portfolio, featuring key opinion leaders, Richard DiPaolo, PhD, and Andrew Cope, MD PhD.
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Poster presentation delivered by Dana-Farber Cancer Institute at the American Society of Gene & Cell Therapy Annual Meeting presented proof-of-concept data on CUE-101 and its potential to control CAR-T cell expansion and persistence in vivo.
Reported new complete response and confirmed 50% overall response rate (ORR) in ongoing Phase 1 trial of CUE-101 and pembrolizumab (KEYTRUDA) in recurrent/metastatic HPV+ head and neck cancer. Data observed included 12-month overall survival of 88% and median overall survival (mOS) of 32 months.
Second Quarter 2025 Financial Results
The Company reported collaboration revenue of $3.0 million and $2.7 million for the three months ended June 30, 2025 and 2024, respectively. The increase was due to the timing of revenue earned from the collaboration and license agreement with Boehringer Ingelheim International GmbH (BI).
Research and development expenses were $7.9 million and $9.5 million for the three months ended June 30, 2025 and 2024, respectively. The decrease was primarily due to decreases in clinical trials costs and employee compensation.
General and administrative expenses were $3.7 million and $3.5 million for the three months ended June 30, 2025 and 2024, respectively. The increase was primarily due to an increase in professional fees.