BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (NASDAQ:CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, today reported fourth quarter and full year 2023 financial results. Presented additional positive data from the ongoing Phase 1 trials of CUE-101 in first line (1L) human papillomavirus positive (HPV+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in combination with standard of care (SOC) checkpoint inhibitor (CPI) KEYTRUDA® (pembrolizumab) and as a monotherapy in second line and beyond (2L+) HPV+ R/M HNSCC, as well as CUE-102 in Wilms' Tumor 1 (WT1) positive cancers at the Society for Immunotherapy of Cancer's (SITC) 38th Annual Meeting in November 2023. Completed enrollment of 25 patients in the 1L Phase 1b dose expansion trial of CUE-101 in combination with SOC CPI pembrolizumab. Presented notable updates from the ongoing Phase 1 clinical trials of CUE-101 and CUE-102 at the 2024 Oppenheimer Annual Healthcare Life Sciences Conference in February: CUE-101 monotherapy in 2L HPV+ R/M HNSCC demonstrated median overall survival (mOS) of 20.8 months vs. historical third-party mOS of 7.5 and 8.4 months with two different CPIs: OPDIVO® (nivolumab) and pembrolizumab, respectively CUE-101 in combination with pembrolizumab in 1L R/M HNSCC showed an overall response rate (ORR) of 46% vs. 19% with pembrolizumab alone in a third-party trial and median progression free survival (mPFS) of 8.3 months vs. 3.2 months with pembrolizumab alone in a third-party trial CUE-101 continued to demonstrate favorable tolerability in the monotherapy and combination trials CUE-102 monotherapy in late-stage refractory metastatic cancers demonstrated tumor reductions and stable disease in multiple patients in the dose escalation Phase 1 trial Concluded Type B meeting with FDA receiving guidance for potential paths for CUE-101 registrational trials in both monotherapy and combination settings. Advanced preclinical program CUE-401 in collaboration with Ono Pharmaceutical for the treatment of autoimmune and inflammatory diseases. Preclinical activity demonstrated in disease models supported moving toward selection of an Investigational New Drug (IND) candidate. Deployed the Immuno-STAT™ platform to develop a therapeutic biologics candidate, CUE-501, a bispecific Immuno-STAT that is designed to direct selective memory T cells to deplete B cells, to address autoimmune and inflammatory diseases. "Cue Biopharma continues to make measurable progress advancing its clinical oncology programs CUE-101 and CUE-102, as well as its lead preclinical autoimmune and inflammatory disease candidate CUE-401, partnered with Ono Pharmaceutical," said Daniel Passeri, chief executive officer of Cue Biopharma. "We also accomplished an important milestone earlier this year with guidance received from the FDA for potential CUE-101 registrational trials both in the monotherapy and combination settings providing further risk-reduction and defined resource requirements for achieving the next phase of our strategic corporate objectives. I believe that these key milestones, including progress addressing additional therapeutic approaches for the treatment of autoimmune and inflammatory diseases with CUE-401 and CUE-501, bolster our competitive positioning in securing value for our shareholders and most importantly, patients suffering from these debilitating and life-threatening diseases." Fourth Quarter 2023 Financial Results The Company reported collaboration revenue of approximately $1.8 million and $0.15 million for the three months ended December 31, 2023 and 2022, respectively. The increase was due to revenue earned from the strategic collaboration agreement entered into with Ono Pharmaceutical in the first quarter of 2023. Research and development expenses were $10.9 million and $11.3 million for the three months ended December 31, 2023 and 2022, respectively. The decrease was primarily due to drug substance manufacturing projects for CUE-101 and CUE-102 completed in 2022. General and administrative expenses were $4.6 million and $3.7 million for the three months ended December 31, 2023 and 2022, respectively. The increase was primarily due to an increase in professional and consulting fees.        Full Year 2023 Financial Results The Company reported collaboration revenue of approximately $5.5 million and $1.2 million for the years ended December 31, 2023 and 2022, respectively. The increase was due to revenue earned from our strategic collaboration agreement entered into with Ono Pharmaceutical in the first quarter of 2023. Research and development expenses were approximately $40.8 million and $38.6 million for the years ended December 31, 2023 and 2022, respectively. The increase was primarily due to increases in clinical development costs and research and laboratory expenses, offset by decreases in employee costs and rent expense. General and administrative expenses were approximately $16.7 million and $16.2 million for the years ended December 31, 2023 and 2022, respectively. The increase was primarily due to an increase in professional and consulting fees. As of December 31, 2023, the Company had approximately $48.5 million in cash, cash equivalents and marketable securities compared with $76.3 million as of December 31, 2022.  We expect our current cash, cash equivalents, and marketable securities to fund operations into the first quarter of 2025.   Cue Biopharma, Inc. Consolidated Statements of Operations and Comprehensive Loss (In thousands, except per share information)       Three Months EndedDecember 31,   Year EndedDecember 31,     2023     2022     2023     2022   Collaboration revenue $ 1,821   $ 151   $ 5,490   $ 1,245   Operating expenses (income):                 General and administrative   4,609     3,704     16,680     16,169   Research and development   10,887     11,332