BUSINESS

ZENAS BIOPHARMA TARGETS KEY 2025 MILESTONES FOR OBEXELIMAB IN AUTOIMMUNE DISEASES

06/02/2025 05:28 PM

KUALA LUMPUR, Feb 6 (Bernama) -- Zenas BioPharma Inc (Zenas), a clinical-stage global biopharmaceutical company, has outlined its significant achievements in 2024 and set key business objectives for 2025.

The company also announced its preliminary unaudited cash balance at the end of 2024, which stands at approximately US$350 million, sufficient to its operating expenses and capital expenditure requirements into the fourth quarter of 2026. (US$1=RM4.41)

Zenas Founder and Chief Executive Officer, Lonnie Moulder highlighted the company’s progress across various goals in 2024, noting that it enters 2025 with major milestones in sight, especially the results from ongoing obexelimab Phase 2 and Phase 3 clinical trials.

“We are extremely proud of the accomplishments of our dedicated team as we enter the year well-financed and able to focus on execution and achievement of our key objectives for the year,” he said in a statement.

In 2024, Zenas achieved several key milestones, including the completion of patient enrolment for the Phase 3 INDIGO trial, which is the largest-ever clinical trial for Immunoglobulin G4-Related Disease (IgG4-RD).

The company also initiated the Phase 2 MoonStone and SunStone trials for obexelimab in patients with Relapsing Multiple Sclerosis (RMS) and Systemic Lupus Erythematosus (SLE), respectively, as well as provided initial data from the Phase 2 SApHiAre trial.

Additionally, Zenas completed an upsized Series C and initial public offering, raising US$458.7 million, and bolstered its leadership team by appointing Orlando Oliveira as Chief Commercial Officer and Jeff Held as Chief Legal Officer.

The company also made strategic business moves, including out-licenced ZB005 for development in Greater China and out-licenced regional rights to its thyroid eye disease programmes to Zai Lab.

Looking ahead to 2025, Zenas expects to achieve several key clinical milestones, including the release of the 12-week primary endpoint results from the Phase 2 MoonStone trial for RMS in the third quarter; topline results by year-end 2025 from the Phase 3 INDIGO trial in IgG4-RD; and to complete enrolment in the Phase 2 SunStone trial for SLE by 2025, with topline results expected in the first half of 2026.

The ongoing clinical trials underscore Zenas' commitment to advancing obexelimab as a groundbreaking treatment for multiple autoimmune diseases with a once-weekly subcutaneous injection regimen.

-- BERNAMA

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