A Study of Imvotamab in Severe Systemic Lupus Erythematosus

Key Inclusion Criteria:

• Age ≥ 18 years at the time of signing ICF

• Diagnosis of SLE according to the 2019 European League Against Rheumatism/AmericanCollege of Rheumatology (ACR) Classification Criteria at least 16 weeks or moreprior to screening

• Highly active SLE disease, as demonstrated by a total systemic lupus erythematosusdisease activity index (SLEDAI-2K) total score of ≥ 10 at screening

• Active SLE disease despite treatment with at least 1 immunosuppressive or biologicstandard-of-care agent (e.g., methotrexate, azathioprine, mycophenolate mofetil,belimumab, anifrolumab) determined at the discretion of the investigator after atleast 3 months of treatment.

• It must be planned that the background standard-of-care treatment remains at astable dose throughout the Screening Period and up to Week 8.

Key Exclusion Criteria:

• Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab.

• Any lupus-associated neuropsychiatric disease.

• Active lupus nephritis with estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2, calculated according to the Chronic Kidney Disease EpidemiologyCollaboration equation, classified as World Health Organization (WHO) Class IV.

• Prednisone-equivalent > 30 mg/day, including immediate and extended-release oralformulations.

• Drug-induced lupus.

• Participants with a history of catastrophic or severe anti-phospholipid syndromewithin 12 months prior to screening.