Cue Biopharma(CUE) - 2025 Q2 - Quarterly Results

Business Highlights Cue Biopharma achieved positive clinical data for CUE-101, advanced its autoimmune pipeline, secured a $12 million collaboration, and raised $20 million - Reported encouraging clinical data from the Phase 1b trial of CUE-101 for HPV+ HNSCC, with a new complete response and a confirmed 50% overall response rate (ORR). The 12-month overall survival was 88% and median overall survival (mOS) reached 32 months[3][7] - Received positive FDA feedback on the Pre-IND Briefing Document for CUE-401, supporting the planned IND submission for treating autoimmune diseases[5][6] - Announced a strategic research collaboration and license agreement with Boehringer Ingelheim to develop CUE-501 for autoimmune diseases, which includes a $12 million upfront payment and up to approximately $345 million in potential milestone payments[5][6] - Successfully raised approximately $20 million through a public offering to support operations[5][6] Financial Performance Collaboration revenue increased to $3.0 million, operating expenses decreased, leading to a reduced net loss of $8.5 million, and cash improved to $27.5 million Second Quarter 2025 Financial Results Q2 2025 collaboration revenue rose to $3.0 million, R&D expenses decreased to $7.9 million, and G&A expenses slightly increased to $3.7 million Q2 2025 vs Q2 2024 Financial Summary | Financial Metric | Q2 2025 | Q2 2024 | Change Driver | | :--- | :--- | :--- | :--- | | Collaboration Revenue | $3.0 million | $2.7 million | Timing of revenue from BI collaboration | | R&D Expenses | $7.9 million | $9.5 million | Decreases in clinical trials costs and employee compensation | | G&A Expenses | $3.7 million | $3.5 million | Increase in professional fees | Condensed Consolidated Statements of Operations Net loss for Q2 2025 narrowed to $8.5 million (or $0.09 per share), and for the six months, it improved to $20.7 million Statement of Operations Highlights (Three Months Ended June 30, in thousands) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Collaboration revenue | $2,954 | $2,658 | | Total operating expenses | $11,589 | $13,041 | | Loss from operations | $(8,635) | $(10,383) | | Net loss | $(8,482) | $(10,171) | | Net loss per share | $(0.09) | $(0.20) | Statement of Operations Highlights (Six Months Ended June 30, in thousands) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Collaboration revenue | $3,374 | $4,375 | | Total operating expenses | $24,309 | $27,426 | | Loss from operations | $(20,935) | $(23,051) | | Net loss | $(20,739) | $(22,518) | | Net loss per share | $(0.24) | $(0.45) | Condensed Consolidated Balance Sheets Cash and cash equivalents increased to $27.5 million, total assets grew to $40.7 million, and stockholders' equity remained stable at $18.2 million Balance Sheet Summary (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $27,492 | $22,459 | | Total assets | $40,707 | $32,191 | | Liabilities | $22,548 | $14,692 | | Stockholders' equity | $18,159 | $17,499 | Corporate Information and Forward-Looking Statements Cue Biopharma, a clinical-stage biopharmaceutical company, develops injectable biologics using its Immuno-STAT® platform, with forward-looking statements subject to various risks About Cue Biopharma Cue Biopharma is a clinical-stage company developing injectable biologics using its proprietary Immuno-STAT® platform to selectively modulate disease-specific T cells - The company's core technology is the proprietary Immuno-STAT® (Selective Targeting and Alteration of T cells) platform[14] - The company's focus is on developing injectable biologics to selectively modulate disease-specific T cells for treating cancer and autoimmune diseases[14] Forward-Looking Statements This section details risks and uncertainties for forward-looking statements, including CUE-101 potential, IND submissions, and milestone payments, citing operational and financial challenges - Forward-looking statements in the release cover the potential of CUE-101, plans for an IND submission for CUE-401, and potential future milestone payments[16] - Key risks identified include a limited operating history, history of losses, ability to obtain adequate financing, potential for negative clinical trial results, and securing FDA approvals[16][17]