Bioage Labs, Inc.(BIOA) - 2024 Q4 - Annual Results

Business Highlights and Pipeline Update BioAge provides updates on its APJ agonist and NLRP3 inhibitor programs, alongside new strategic collaborations APJ Agonists Program Update BioAge discontinued its azelaprag Phase 2 trial for obesity due to liver transaminitis, but is developing new APJ agonists - The STRIDES Phase 2 clinical trial for azelaprag in combination with tirzepatide for obesity was discontinued in December 2024[3] - The discontinuation was due to observations of unexpected liver transaminitis in patients, a risk not predicted by prior Phase 1 or toxicology studies[3][4] - BioAge is continuing to develop next-generation APJ agonists for obesity that are structurally different from azelaprag[4] NLRP3 Inhibitor Program: BGE-102 BioAge nominated BGE-102, a brain-penetrant NLRP3 inhibitor, as a candidate for neuroinflammation, with Phase 1 data expected 2H25 - BGE-102, an oral small-molecule NLRP3 inhibitor with high brain penetration, was nominated as a development candidate in January 2025[8] - Preclinical models show BGE-102 can induce weight loss both as a monotherapy and in combination with a GLP-1 receptor agonist[8] - Clinical timeline: Phase 1 SAD data is expected in 2H25, followed by MAD data in 1H26[8] Platform and Strategic Collaborations BioAge established strategic collaborations with Novartis and Lilly to discover drug targets and therapeutic antibodies for age-related diseases - Established a multi-year collaboration with Novartis in December 2024 to discover novel drug targets for age-related diseases[8] - The Novartis deal includes up to $20 million in upfront payments and research funding, with potential for an additional $530 million in future milestones[8] - Announced a strategic collaboration with Lilly in January 2025 to discover two therapeutic antibodies for metabolic aging targets[8] Full Year 2024 Financial Performance BioAge reports a $71.1 million net loss for FY2024, with increased R&D expenses and a strong $354.3 million cash position Financial Results Summary BioAge reported a $71.1 million net loss in FY2024, driven by increased R&D, ending with $354.3 million cash FY 2024 vs FY 2023 Financial Highlights | Metric | FY 2024 | FY 2023 | | :--- | :--- | :--- | | R&D Expenses | $59.0 million | $33.9 million | | G&A Expenses | $19.2 million | $14.5 million | | Net Loss | $71.1 million | $63.9 million | | Net Loss per Share | $6.63 | $38.17 | | Cash & Equivalents (EOY) | $354.3 million | $21.6 million | - The $25.1 million increase in R&D expenses was primarily due to a $22.8 million increase in costs related to the development and manufacturing of azelaprag for its Phase 2 trial[7] - The company's cash and cash equivalents of $354.3 million are expected to fund operations and capital expenses through 2029[11] Unaudited Consolidated Statements of Operations and Comprehensive Loss Total operating expenses increased to $78.2 million in 2024, resulting in a net loss of $71.1 million or $6.63 per share Consolidated Statements of Operations (in thousands) | Line Item | 2024 | 2023 | | :--- | :--- | :--- | | Research and development | $59,036 | $33,886 | | General and administrative | $19,158 | $14,514 | | Total operating expenses | $78,194 | $48,400 | | Loss from operations | $(78,194) | $(48,400) | | Total other income (expense), net | $7,085 | $(15,454) | | Net loss | $(71,109) | $(63,854) | | Net loss per share | $(6.63) | $(38.17) | Unaudited Consolidated Balance Sheets Cash and equivalents surged to $354.3 million by Dec 31, 2024, significantly strengthening the balance sheet Consolidated Balance Sheet Highlights (in thousands) | Line Item | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $354,349 | $21,644 | | Total assets | $358,234 | $25,924 | | Liabilities & Equity | | | | Total liabilities | $35,107 | $66,598 | | Total stockholders' equity (deficit) | $323,127 | $(173,396) | Company and Legal Information This section provides an overview of BioAge's focus and important disclaimers regarding forward-looking statements About BioAge Labs, Inc. BioAge is a clinical-stage biopharmaceutical company developing metabolic disease treatments by targeting aging biology - BioAge is a clinical-stage company focused on developing therapies for metabolic diseases by targeting the biology of aging[12] - The company's pipeline includes NLRP3 inhibitors, APJ agonists, and other preclinical programs based on its human longevity data platform[12] Forward-looking Statements The report contains forward-looking statements on clinical plans and financial outlook, subject to risks detailed in SEC filings - The report contains forward-looking statements regarding clinical development timelines (e.g., BGE-102), potential benefits of product candidates, collaboration outcomes, and cash runway sufficiency[13] - These statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations[13] - Investors are advised to review the "Risk Factors" section in the company's Form 10-K and other SEC filings for a comprehensive understanding of potential risks[14]