Zenas BioPharma (ZBIO) investor relations material

Key clinical results and product profile

• Obexelimab showed a 56% risk reduction in time to disease flare for IgG4-RD, with 75% of patients flare-free and strong durability at six months in the open-label extension, where 92% remained flare-free.

• All key secondary endpoints were met with high statistical significance, and safety outcomes were comparable to placebo, including low rates of serious adverse events and infections.

• Subcutaneous administration was well tolerated, with injection site reactions similar to placebo, supporting at-home use.

• Market research with physicians indicated a strong preference for the inhibitory approach due to safety and convenience, with 64% likely to prescribe and a projected 47% market share for obexelimab.

• Patient preference studies showed 75% favored subcutaneous administration over IV, reinforcing the product’s convenience.

Commercial outlook and launch plans

• Estimated 20,000 diagnosed and managed IgG4-RD patients in the US, with a potential $3–$4 billion market opportunity based on current pricing.

• Obexelimab is expected to achieve over $1 billion in US sales, with a launch strategy including prefilled syringes and an autoinjector within a year.

• The US sales force will comprise about 70 people, targeting rheumatologists and gastroenterologists; European launch will start in Germany, expanding to Italy and France over three years.

• Medicare patients represent 40–45% of the target population, and pricing is expected to be competitive with existing therapies.

• Regulatory filings are planned for Q2 in the US and the second half of the year in Europe, with the autoinjector submission following initial approval.

Pipeline and future development

• The lupus (SLE) Sunstone study will report top-line results in Q4, focusing on the BICLA endpoint and a gene-based biomarker, with strict screening to ensure robust data.

• The BTK inhibitor orelibrutinib is in a PPMS trial, with a non-active SPMS study starting soon, aiming for strong CNS penetration and once-daily dosing.

• Oral IL-17 (ZB021) will enter the clinic mid-year, with rapid progression to patient studies in psoriasis and data expected next year; TYK2 brain-penetrant will start phase 1 at year-end.

• The pipeline is described as extensive and fast-moving, with multiple programs advancing in parallel.