Cue Biopharma(CUE) - 2024 Q1 - Quarterly Results

About Cue Biopharma Cue Biopharma is a clinical-stage biopharmaceutical company developing novel injectable biologics via its Immuno-STAT™ platform Company Overview and Platform Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of injectable biologics using its proprietary Immuno-STAT™ platform - Cue Biopharma is a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells[6][15] - The company's proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells), is designed to harness the body's intrinsic immune system through selective modulation of disease-specific T cells[6] - Headquartered in Boston, Massachusetts, the company is led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology[12] Recent Business Highlights The company advanced clinical programs, expanded its pipeline, and secured multiple conference presentations Clinical Program Advancements Cue Biopharma made significant progress in its clinical programs, advancing CUE-101 and CUE-102 trials - Significant progress made in advancing the CUE-101 clinical trial, including a meeting with the FDA to define a registrational path forward[8] - Continued advancement of the Phase 1 clinical trial for CUE-102[8] Pipeline Expansion and Collaborations The company expanded its pipeline with the preclinical CUE-500 series and advanced the CUE-401 program with Ono Pharmaceutical - Expanded pipeline to include the preclinical CUE-500 series for the treatment of autoimmune and inflammatory diseases via T cell-mediated B cell depletion[2][8] - Advanced preclinical CUE-401 program, in collaboration with Ono Pharmaceutical, with potential for broad application across multiple autoimmune and inflammatory diseases[7][8] Conference Presentations Multiple abstracts related to CUE-101, CUE-102, and the Immuno-STAT™ platform were accepted for upcoming scientific conferences - CUE-101 abstract accepted for an oral presentation and poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (May 31-June 4, 2024)[1] - CUE-102 abstract accepted for a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (May 31-June 4, 2024)[16] - Immuno-STAT™ platform posters for oncology and autoimmune diseases accepted for presentation at PEGS Boston Summit 2024 (May 13-14)[17] First Quarter 2024 Financial Results First quarter 2024 financial results detail cash position, operational performance, and balance sheet changes Cash and Cash Equivalents As of March 31, 2024, Cue Biopharma reported $41.0 million in cash and cash equivalents, projected to fund operations into Q1 2025 - As of March 31, 2024, the Company had $41.0 million in cash and cash equivalents[4] - Current cash and cash equivalents are expected to fund operations into the first quarter of 2025[4][23] Condensed Consolidated Statements of Operations and Comprehensive Loss For Q1 2024, collaboration revenue significantly increased, R&D expenses rose, and the net loss was $12.3 million Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited, In thousands) | Metric | Q1 2024 ($) | Q1 2023 ($) | Change ($) | Change (%) | | :----------------------------------------- | :---------- | :---------- | :--------- | :--------- | | Collaboration revenue | 1,717 | 187 | 1,530 | 818.18% | | General and administrative expenses | 4,186 | 4,176 | 10 | 0.24% | | Research and development expenses | 10,199 | 9,391 | 808 | 8.60% | | Total operating expenses | 14,385 | 13,567 | 818 | 6.03% | | Loss from operations | (12,668) | (13,380) | 712 | -5.32% | | Net loss | (12,347) | (13,109) | 762 | -5.81% | | Net loss per common share – basic and diluted | (0.25) | (0.29) | 0.04 | -13.79% | | Weighted average common shares outstanding | 49,466,711 | 44,652,353 | 4,814,358 | 10.78% | - Collaboration revenue increased to $1.7 million in Q1 2024 from $0.2 million in Q1 2023, primarily due to revenue earned from the Collaboration and Option Agreement with Ono Pharmaceutical[18][19] - Research and development expenses increased to $10.2 million in Q1 2024 from $9.4 million in Q1 2023, primarily due to an increase in clinical trial expenses[18][19] Condensed Consolidated Balance Sheets As of March 31, 2024, total assets decreased to $53.95 million, driven by a reduction in cash and cash equivalents Condensed Consolidated Balance Sheets (Unaudited, In thousands) | Metric | March 31, 2024 ($) | December 31, 2023 ($) | Change ($) | Change (%) | | :----------------------------------- | :----------------- | :-------------------- | :--------- | :--------- | | Cash and cash equivalents | 41,029 | 48,514 | (7,485) | -15.43% | | Other assets | 12,922 | 13,016 | (94) | -0.72% | | Total assets | 53,951 | 61,530 | (7,579) | -12.32% | | Liabilities | 23,913 | 24,445 | (532) | -2.18% | | Stockholders' equity | 30,038 | 37,085 | (7,047) | -19.00% | | Total Liabilities and stockholders' equity | 53,951 | 61,530 | (7,579) | -12.32% | Forward-Looking Statements This section outlines forward-looking statements, associated risks, and the company's disclaimer regarding updates Disclaimer and Risk Factors This section contains forward-looking statements and highlights various factors that could cause actual results to differ materially - The press release contains forward-looking statements regarding the company's strategies, prospects, financial condition, operations, costs, plans, and objectives[14][23] - Important factors that could cause actual results to differ materially include limited operating history, ability to achieve profitability, potential setbacks in R&D efforts, challenges in securing regulatory approvals, reliance on collaborators, ability to obtain adequate financing, and competitive factors[14] - The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time[14] Contact Information This section provides essential contact details for investor relations and media inquiries Investor and Media Contacts Contact information is provided for investor relations and media inquiries - Investor Contact: Marie Campinell, Senior Director, Corporate Communications, mcampinell@cuebio.com[14] - Media Contact: Jonathan Pappas, LifeSci Communications, jpappas@lifescicomms.com[24]