Zenas BioPharma, Inc.(ZBIO) - 2025 Q2 - Quarterly Results

Company Overview and Recent Developments This section provides an overview of Zenas BioPharma, its strategic focus on autoimmune diseases, and recent progress in its obexelimab clinical development program Company Profile Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases, leveraging an experienced leadership team and a disciplined product candidate acquisition approach - Zenas BioPharma is a clinical-stage global biopharmaceutical company specializing in transformative therapies for autoimmune diseases[8] - The company's strategy involves an experienced leadership team and a disciplined approach to acquiring and developing product candidates globally[8] Key Highlights and CEO Commentary Zenas BioPharma reported Q2 2025 financial results and corporate updates, highlighting rapid advancement of its obexelimab program, including Phase 2 MoonStone enrollment completion and anticipated Phase 3 INDIGO topline results, with cash runway into Q4 2026 - Topline results from the pivotal Phase 3 INDIGO trial in Immunoglobulin G4-Related Disease are expected around year-end 2025[1] - Enrollment for the Phase 2 MoonStone trial in Relapsing Multiple Sclerosis has been completed, with results expected early in the fourth quarter of 2025[1] - Cash, cash equivalents, and investments totaled $274.9 million as of June 30, 2025, providing a cash runway into the fourth quarter of 2026[1] - CEO Lonnie Moulder expressed satisfaction with the rapid advancement of the obexelimab program and highlighted the differentiated profile of obexelimab and the company's capabilities to address autoimmune diseases[2] Obexelimab Clinical Development Updates Zenas BioPharma updated on obexelimab, its lead bifunctional monoclonal antibody, advancing multiple Phase 2 and Phase 3 trials for autoimmune diseases with key milestones expected through mid-2026 - Obexelimab is a bifunctional monoclonal antibody that binds CD19 and FcγRIIb to inhibit B cell activity without depleting them, offering a unique mechanism of action for autoimmune diseases[6][8] - Obexelimab has been evaluated in five completed clinical trials involving 198 subjects, demonstrating good tolerability and pharmacologic activity, providing initial clinical proof of concept[7] - Zenas is currently conducting multiple Phase 2 and Phase 3 trials for obexelimab in autoimmune diseases including IgG4-RD, RMS, and SLE[7] - Obexelimab's self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease[6][8] Immunoglobulin G4-Related Disease (IgG4-RD) - INDIGO Trial The global Phase 3 INDIGO trial for obexelimab in IgG4-RD, the largest to date, concluded enrollment in November 2024, with topline results expected around year-end 2025 - The Phase 3 INDIGO trial for obexelimab in IgG4-RD is a global, registration-directed, multicenter, randomized, double-blind, placebo-controlled trial[3] - Target enrollment for the INDIGO trial concluded in November 2024[3] - Topline results from the INDIGO trial are expected around year-end 2025[1][3] - The INDIGO trial is the largest clinical trial conducted in patients living with IgG4-RD to date[3] Relapsing Multiple Sclerosis (RMS) - MoonStone Trial Enrollment for the Phase 2 MoonStone trial of obexelimab in Relapsing Multiple Sclerosis has been completed, and Zenas expects to report results, including the 12-week primary endpoint, early in the fourth quarter of 2025 - Enrollment for the Phase 2 MoonStone trial in Relapsing Multiple Sclerosis has been completed[1][3] - Results from the MoonStone trial, including the 12-week primary endpoint, are expected early in the fourth quarter of 2025[1][3] - The MoonStone trial is a multicenter, randomized, double-blind, placebo-controlled trial evaluating obexelimab's efficacy and safety in RMS patients[3] Systemic Lupus Erythematosus (SLE) - SunStone Trial Enrollment for the Phase 2 SunStone trial of obexelimab in Systemic Lupus Erythematosus is ongoing and is expected to be completed by year-end 2025, with topline results anticipated in mid-2026 - Enrollment for the Phase 2 SunStone trial in Systemic Lupus Erythematosus is expected to be completed by year-end 2025[1][4] - Topline results from the SunStone trial are expected in mid-2026[1][4] - The SunStone trial is a multicenter, randomized, double-blind, placebo-controlled trial evaluating obexelimab's efficacy and safety in SLE patients[4] Second Quarter 2025 Financial Results This section details Zenas BioPharma's financial performance for Q2 2025, including net loss, operating expenses, and cash position, highlighting increased R&D and G&A expenses Financial Summary and Cash Runway Zenas BioPharma reported a Q2 2025 net loss of $52.2 million, an increase from Q2 2024, due to higher R&D and G&A expenses, while maintaining a $274.9 million cash position with runway into Q4 2026 Cash, Cash Equivalents and Investments | Metric | As of June 30, 2025 | | :--- | :--- | | Cash, cash equivalents and investments | $274.9 million | - The company expects its cash, cash equivalents, and investments as of June 30, 2025, to fund operating expenses and capital expenditure requirements into the fourth quarter of 2026[1][9] Net Loss (Q2 2025 vs Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Net Loss | $(52.2) million | $(38.0) million | $(14.2) million | Research and Development (R&D) Expenses (Q2 2025 vs Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | R&D Expenses | $43.0 million | $33.8 million | $9.2 million | - The increase in R&D expenses was primarily due to increased costs related to the clinical development of obexelimab and higher personnel costs, partially offset by a decrease in partnered programs[9] General and Administrative (G&A) Expenses (Q2 2025 vs Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | G&A Expenses | $12.1 million | $5.9 million | $6.2 million | - The increase in G&A expenses was driven by higher personnel costs (including stock-based compensation), pre-commercialization activities, and other expenses associated with operating as a public company[9] Condensed Consolidated Statements of Operations For the three months ended June 30, 2025, Zenas BioPharma reported no revenue, total operating expenses of $55.2 million, and a net loss of $52.2 million, compared to a net loss of $38.0 million in the prior year period Condensed Consolidated Statements of Operations (Three Months Ended June 30) | Metric (in million) | June 30, 2025 | June 30, 2024 | | :--- | :--- | :--- | | License and collaboration revenue | $— | $— | | Total revenue | $— | $— | | Research and development | $43.0 | $33.8 | | General and administrative | $12.1 | $5.9 | | Total operating expenses | $55.2 | $39.7 | | Loss from operations | $(55.2) | $(39.7) | | Other income, net | $3.0 | $1.7 | | Income tax (provision) benefit | $(0.0) | $— | | Net loss to common stockholders | $(52.2) | $(38.0) | | Net loss per share - basic and diluted | $(1.25) | $(24.23) | | Weighted-average common stock outstanding - basic and diluted | 41,865,400 | 1,567,269 | Selected Consolidated Balance Sheet Data As of June 30, 2025, Zenas BioPharma reported cash, cash equivalents, and investments of $274.9 million, total assets of $293.1 million, and total stockholders' equity of $239.6 million Selected Consolidated Balance Sheet Data (As of June 30, 2025) | Metric (in million) | June 30, 2025 | | :--- | :--- | | Cash, cash equivalents and investments | $274.9 | | Working capital | $225.4 | | Total assets | $293.1 | | Accumulated deficit | $(473.2) | | Total stockholders' equity | $239.6 | Forward-Looking Statements and Disclaimers This section contains standard forward-looking statements regarding future events, clinical trial timings, growth strategy, and cash runway guidance, subject to risks and uncertainties that could cause actual results to differ materially, with no public update commitment Forward-Looking Statements This section contains standard forward-looking statements regarding future events, clinical trial timings, growth strategy, and cash runway guidance, subject to risks and uncertainties that could cause actual results to differ materially, with no public update commitment - The press release contains forward-looking statements concerning the timing and results of ongoing and future clinical trials, the ability to impact autoimmune disease treatment, growth strategy, and cash runway guidance[10] - These statements involve risks, uncertainties, and contingencies that may cause actual results to differ materially from anticipated outcomes[10] - Key risks include limited operating history, need for additional financing, uncertainty of clinical development, potential competition, regulatory approval challenges, and reliance on third parties[10] - The company does not undertake to publicly update or revise any forward-looking statements unless required by applicable law[10] Trademarks and Contact Information This section provides information on Zenas BioPharma's trademarks and investor/media contact details - The Zenas BioPharma word mark, logo mark, and the 'lightning bolt' design are trademarks of Zenas BioPharma, Inc. or its affiliated companies[11] - Investor and Media Contact information is provided via Argot Partners[15]