Financial Performance - The net loss for Q3 2024 was $38.6 million, compared to a net income of $35.6 million in Q3 2023, which was influenced by collaboration revenue from Bristol-Myers Squibb[13]. - Research and development (R&D) expenses for Q3 2024 were $33.5 million, a significant increase from $9.4 million in Q3 2023, primarily due to higher costs associated with obexelimab[11]. - General and administrative (G&A) expenses totaled $7.5 million in Q3 2024, up from $5.0 million in Q3 2023, driven by increased personnel and operational costs[12]. - Total operating expenses for Q3 2024 were $41.0 million, compared to $14.4 million in Q3 2023, reflecting the company's investment in growth and clinical trials[17]. Clinical Development - The company achieved targeted enrollment for the Phase 3 INDIGO trial, the largest clinical trial for Immunoglobulin G4-Related Disease (IgG4-RD), with topline results expected by the end of 2025[2][4]. - The company initiated the Phase 2 MoonStone trial for obexelimab in Relapsing Multiple Sclerosis, with primary endpoint results anticipated by Q3 2025[5]. Funding and Growth Strategy - Zenas BioPharma completed its initial public offering, raising approximately $258.7 million in gross proceeds to fund the clinical development of obexelimab and support its growth strategy[1][8]. - As of September 30, 2024, the company's cash balance was $386.8 million, including net proceeds of $234.4 million from the IPO, expected to fund operations into Q4 2026[14]. Leadership Changes - The company appointed Orlando Oliveira as Chief Commercial Officer and Jeff Held as Chief Legal Officer to strengthen its leadership team[9]. Licensing and Partnerships - Zenas BioPharma out-licensed ZB005, a human IgG4 monoclonal antibody, for a non-refundable upfront payment and potential milestone payments[10].

Core Insights - Zenas BioPharma completed its initial public offering, raising $258.7 million to support the clinical development of its lead product candidate, obexelimab, and its growth strategy [1][7] - The company has achieved targeted enrollment for the Phase 3 INDIGO trial, which is the largest clinical trial for Immunoglobulin G4-Related Disease (IgG4-RD), with topline results expected by the end of 2025 [2][4] Clinical Development - Obexelimab is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, designed to inhibit the activity of B cells involved in autoimmune diseases without depleting them [3][14] - The Phase 2 MoonStone trial has been initiated to evaluate obexelimab's efficacy and safety in patients with Relapsing Multiple Sclerosis (RMS), with primary endpoint results expected by Q3 2025 [5] - The Phase 2 SunStone trial is also underway to assess obexelimab in patients with Systemic Lupus Erythematosus (SLE), with topline results anticipated in the first half of 2026 [6] - Enrollment continues in the Phase 2 SApHiAre trial for warm Autoimmune Hemolytic Anemia (wAIHA), with initial data expected later this year [7] Financial Performance - For Q3 2024, research and development expenses were $33.5 million, a significant increase from $9.4 million in Q3 2023, primarily due to costs associated with obexelimab's clinical development [10] - General and administrative expenses rose to $7.5 million from $5.0 million in the same period last year, attributed to increased personnel and operational costs [11] - The net loss for Q3 2024 was $38.6 million, compared to a net income of $35.6 million in Q3 2023, which was influenced by collaboration revenue from Bristol-Myers Squibb [12][16] Cash Position - As of September 30, 2024, the company's cash balance was $386.8 million, including net proceeds of $234.4 million from the IPO, expected to fund operations into Q4 2026 [13][17]

Core Insights - Zenas BioPharma has completed targeted enrollment for the Phase 3 INDIGO trial, the largest clinical trial for patients with IgG4-RD, and expects topline results by the end of 2025 [1][2] Company Overview - Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing and commercializing immunology-based therapies [9] - The company's lead product candidate, obexelimab, is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb to inhibit B cell activity without depleting them [9] INDIGO Trial Details - The Phase 3 INDIGO trial is a global, double-blind, placebo-controlled study involving approximately 190 patients across 100 sites in 20 countries [3] - Patients are randomized to receive either 250 mg of obexelimab or placebo weekly for 52 weeks, followed by an open-label extension period [3] - The primary efficacy endpoint is the time to first IgG4-RD flare, with secondary endpoints including annualized flare rate and complete remission rates [4] Obexelimab Clinical Background - Obexelimab has been evaluated in five completed clinical trials with a total of 198 patients, demonstrating good tolerance and clinical activity [5] - The drug is currently being tested in multiple Phase 2 and Phase 3 trials for various autoimmune diseases, including IgG4-RD, Multiple Sclerosis, and Systemic Lupus Erythematosus [5] IgG4-RD Overview - IgG4-RD is a chronic fibro-inflammatory disease affecting multiple organ systems, with an estimated 20,000 diagnosed patients in the U.S. [6] - There are currently no approved therapies for IgG4-RD, and the standard treatment involves glucocorticoids, which can lead to complications and relapses [7] Therapeutic Landscape - B cell-targeted therapies are suggested to provide benefits for IgG4-RD, although existing agents like rituximab are not approved for this indication and carry risks of infections [8]

WALTHAM, Mass, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. ("Zenas" or the "Company") (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative immunology-based therapies, today announced the Company's participation at the following healthcare investor conferences: Guggenheim's Inaugural Healthcare Innovation Conference on November 12, 2024, in Boston, MA Jefferies London Healthcare Conference on Novem ...