Zenas BioPharma, Inc.(ZBIO) - 2025 Q1 - Quarterly Results

Zenas BioPharma Q1 2025 Corporate and Financial Update Corporate Updates and Pipeline Progress Zenas BioPharma advanced its obexelimab clinical programs with key trial enrollments and data readouts, while also strengthening its leadership and securing a regional licensing agreement Obexelimab Program Updates Key clinical trials for obexelimab, including Phase 3 INDIGO and Phase 2 MoonStone and SunStone, are progressing with anticipated data readouts - The pivotal Phase 3 INDIGO trial for Immunoglobulin G4-Related Disease (IgG4-RD) has completed enrollment, with topline results expected around year-end 2025[1][3] - Enrollment for the Phase 2 MoonStone trial in Relapsing Multiple Sclerosis (RMS) is concluding, and topline results are anticipated in the early fourth quarter of 2025[1][5] - The Phase 2 SunStone trial in Systemic Lupus Erythematosus (SLE) is expected to complete enrollment by year-end 2025, with topline results projected for mid-2026[1][5] Other Corporate Highlights Zenas BioPharma strengthened its leadership team with key appointments and secured a regional licensing deal for its thyroid eye disease program - Strengthened the leadership team with the appointments of Lisa von Moltke, M.D., as Head of Research and Development and Chief Medical Officer, and Haley Laken, Ph.D., as Chief Scientific Officer[1][5] - Out-licensed regional rights in Greater China for its thyroid eye disease program (ZB001) to Zai Lab. Zenas received an upfront payment and is eligible for future milestone payments and royalties[5] First Quarter 2025 Financial Results For Q1 2025, Zenas BioPharma reported $10.0 million in licensing revenue, an increased net loss of $33.6 million due to higher operating expenses, and maintained a strong cash position of $314.2 million, providing a financial runway into Q4 2026 - As of March 31, 2025, cash, cash equivalents, and investments totaled $314.2 million[1][5] - The current cash position is expected to fund operating expenses and capital expenditure requirements into the fourth quarter of 2026[1][5] Q1 2025 vs Q1 2024 Financial Performance (in millions) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | License and collaboration revenue | $10.0 | $0.0 | +$10.0 | | Research and development (R&D) expenses | $34.9 | $22.6 | +$12.3 | | General and administrative (G&A) expenses | $12.4 | $4.9 | +$7.5 | | Net loss | $33.6 | $27.8 | +$5.8 | | Net loss per share | ($0.80) | ($17.89) | N/A | Detailed Financial Statements This section presents the unaudited condensed consolidated statements of operations for the three months ended March 31, 2025, and selected consolidated balance sheet data as of March 31, 2025 Condensed Consolidated Statements of Operations This table provides the unaudited condensed consolidated statements of operations for the three months ended March 31, 2025 and 2024 Condensed Consolidated Statements of Operations (Unaudited, in thousands) | | Three Months Ended March 31, | | | :--- | :--- | :--- | | | 2025 | 2024 | | Revenue: | | | | License and collaboration revenue | $10,000 | $— | | Total revenue | $10,000 | $— | | Operating expenses: | | | | Research and development | $34,915 | $22,645 | | General and administrative | $12,415 | $4,933 | | Total operating expenses | $47,330 | $27,578 | | Loss from operations | ($37,330) | ($27,578) | | Other income (expense), net | $3,552 | ($222) | | Income tax benefit | $205 | $— | | Net loss to common stockholders | ($33,573) | ($27,800) | | Net loss per share - basic and diluted | ($0.80) | ($17.89) | | Weighted-average common stock outstanding | 41,800,802 | 1,554,087 | Selected Consolidated Balance Sheet Data This table presents selected unaudited consolidated balance sheet data as of March 31, 2025 Selected Consolidated Balance Sheet Data (Unaudited, in thousands) | | March 31, 2025 | | :--- | :--- | | Cash, cash equivalents and investments | $314,214 | | Working capital | $268,675 | | Total assets | $333,766 | | Accumulated deficit | ($420,964) | | Total stockholders' equity | $284,317 | Company and Product Information Zenas BioPharma is a clinical-stage biopharmaceutical company focused on developing therapies for autoimmune diseases, with its lead product obexelimab designed as a bifunctional antibody to inhibit B cell activity without depletion About Obexelimab Obexelimab is a bifunctional monoclonal antibody designed to inhibit B cell activity without depletion, showing promising clinical activity and tolerability - Obexelimab is a bifunctional monoclonal antibody that binds to both CD19 and FcγRIIb on B cells to inhibit their activity without depleting them[6] - The drug has been evaluated in five completed clinical trials involving 198 patients, where it was well tolerated and showed clinical activity, providing initial proof of concept[7] About Zenas BioPharma, Inc. Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on acquiring and developing product candidates for autoimmune diseases - Zenas is a clinical-stage global biopharmaceutical company focused on developing and commercializing therapies for autoimmune diseases[8] - The company's core strategy involves acquiring and developing product candidates with the potential to offer superior clinical benefits to patients with autoimmune diseases[8]