Company Overview - Zenas BioPharma, Inc. is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [2] - The company's lead product candidate, obexelimab, is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb to inhibit the activity of B cells involved in autoimmune diseases without depleting them [2] - Zenas aims to leverage its experienced leadership and disciplined product acquisition strategy to identify and develop candidates that provide superior clinical benefits for patients [2] Upcoming Events - Zenas will present at the Citi's 2025 Biopharma Back to School Conference on September 2, 2025, at 1:00 p.m. ET [3] - The company will also participate in the Cantor Global Healthcare Conference 2025 on September 3, 2025, at 8:35 a.m. ET [3] - Additionally, Zenas is scheduled to present at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 10, 2025, at 7:45 a.m. ET [3]

Core Insights - Zenas BioPharma is advancing its obexelimab development program, with key clinical trials ongoing for autoimmune diseases, including the Phase 3 INDIGO trial for Immunoglobulin G4-Related Disease (IgG4-RD) and the Phase 2 MoonStone trial for Relapsing Multiple Sclerosis (RMS) [1][2][4] Clinical Trials - The Phase 3 INDIGO trial for IgG4-RD is the largest clinical trial conducted for this condition, with topline results expected around year-end 2025 [1][4] - Enrollment for the Phase 2 MoonStone trial in RMS has been completed, with results anticipated in early Q4 2025 [1][4] - The Phase 2 SunStone trial for Systemic Lupus Erythematosus (SLE) is expected to complete enrollment by year-end 2025, with topline results projected for mid-2026 [1][4] Financial Overview - As of June 30, 2025, Zenas BioPharma reported cash, cash equivalents, and investments totaling $274.9 million, which is expected to fund operations into Q4 2026 [1][4][16] - Research and development (R&D) expenses for Q2 2025 were $43.0 million, an increase from $33.8 million in Q2 2024, primarily due to higher clinical development costs for obexelimab [4][9] - General and administrative (G&A) expenses rose to $12.1 million in Q2 2025 from $5.9 million in Q2 2024, attributed to increased personnel costs and pre-commercialization activities [9][14] Product Information - Obexelimab is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, designed to inhibit B cell function without depleting them, potentially addressing chronic autoimmune diseases effectively [5][7] - The drug has shown pharmacologic activity in five completed clinical trials involving 198 subjects, indicating its potential as a potent B cell inhibitor [6]

Company Overview - Zenas BioPharma, Inc. is a clinical-stage global biopharmaceutical company focused on developing and commercializing therapies for autoimmune diseases [3] - The company's lead product candidate, obexelimab, is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, aimed at inhibiting the activity of B cells involved in autoimmune diseases without depleting them [3] - Zenas aims to leverage its experienced leadership and disciplined product acquisition strategy to identify and develop candidates that provide superior clinical benefits for patients with autoimmune diseases [3] Stock Option Grant - On June 16, 2025, Zenas granted a non-qualified stock option to purchase 112,000 shares of common stock to a newly hired employee as an inducement for employment [1] - The stock option has a ten-year term with an exercise price of $9.97, equal to the closing price on the grant date [2] - The option will vest over four years, with 25% vesting on the one-year anniversary of employment and the remainder vesting in 36 equal monthly installments, contingent on the employee's continued service [2]

Core Insights - Zenas BioPharma is advancing its obexelimab program through multiple clinical trials, with topline results expected in late 2025 for Immunoglobulin G4-Related Disease and early Q4 2025 for Relapsing Multiple Sclerosis [1][2][4] Clinical Trials - The Phase 3 INDIGO trial for Immunoglobulin G4-Related Disease is the largest clinical trial conducted for this condition, with topline results anticipated around year-end 2025 [1][4] - The Phase 2 MoonStone trial for Relapsing Multiple Sclerosis is concluding enrollment, with topline results expected early in Q4 2025 [1][4] - The Phase 2 SunStone trial for Systemic Lupus Erythematosus is expected to complete enrollment by year-end 2025, with topline results anticipated in mid-2026 [1][4] Leadership Changes - The company has strengthened its 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][4] Financial Position - As of March 31, 2025, Zenas BioPharma reported cash, cash equivalents, and investments totaling $314.2 million, which is expected to fund operations into Q4 2026 [1][11] - License and collaboration revenue for Q1 2025 was $10 million, attributed to a sublicense agreement with Zai Lab [11] - Research and development expenses increased to $34.9 million in Q1 2025 from $22.6 million in Q1 2024, primarily due to clinical development costs for obexelimab [11] - General and administrative expenses rose to $12.4 million in Q1 2025 from $4.9 million in Q1 2024, driven by increased personnel costs and pre-commercialization activities [11] Product Overview - Obexelimab is a bifunctional monoclonal antibody designed to inhibit B cell function without depleting them, targeting autoimmune diseases [3][7][9] - The drug has shown clinical activity in five completed trials involving 198 patients, providing initial proof of concept for its efficacy [8]