Zenas BioPharma, Inc.(ZBIO) - 2024 Q4 - Annual Results

Financial Position - The company has approximately $350 million in cash, cash equivalents, and short-term investments as of December 31, 2024, expected to fund operations into Q4 2026[2] - The company completed an upsized Series C and IPO, raising approximately$458.7 million in gross proceeds to support obexelimab and growth strategy[5] Clinical Trials - Topline results from the Phase 2 MoonStone trial in Relapsing Multiple Sclerosis are anticipated in Q3 2025[1] - Topline results from the pivotal Phase 3 INDIGO trial in Immunoglobulin G4-Related Disease are expected by year-end 2025[1] - The Phase 3 INDIGO trial is the largest clinical trial ever conducted in patients with IgG4-RD, involving approximately 190 patients across 100 sites in 20 countries[14] - The Phase 2 SunStone trial in Systemic Lupus Erythematosus is expected to complete enrollment in 2025, with topline results projected in the first half of 2026[13] - Obexelimab has been evaluated in five completed clinical trials involving a total of 198 patients, demonstrating clinical activity and tolerability[4] - The primary endpoint of the Phase 2 MoonStone trial is the change in the cumulative number of gadolinium-enhancing lesions on MRI after 12 weeks[10] Strategic Partnerships - The company out-licensed its anti-IGF-1R Thyroid Eye Disease programs to Zai Lab, receiving an upfront fee and potential future milestone payments[5] Operational Risks - The Company relies on WuXi Biologics (Hong Kong) Limited for drug substance and drug product manufacturing, which is located in China[18] - The Company acknowledges risks related to operations of suppliers located outside the United States[18] Forward-Looking Statements - Forward-looking statements made by the Company are inherently uncertain and may prove incorrect[18] - The Company does not guarantee future events based on forward-looking statements due to potential risks and uncertainties[18] - Management cannot predict all emerging risks and uncertainties in the evolving environment[18] Research and Development Focus - The company aims to leverage obexelimab's unique mechanism of action to address the pathogenic role of B cells in chronic autoimmune diseases[15]