Material Event (Form 8-K)

Other Events.

The Phase 1b portion of the Phase 1b/2a study (NCT07043946) is evaluating three ascending doses (250 mg, 500 mg and 1000 mg) of intravenous budoprutug, administered in two doses 14 days apart, in adults with primary ITP who have received at least one prior therapy.

As of June 1, 2026, 15 patients had been enrolled across the 250 mg (n=6) and 500 mg (n=9) dose cohorts, median follow-up was 38 weeks and 12 weeks for the 250 mg and 500 mg cohorts, respectively.

Patients enrolled were heavily pretreated, with a median of 6 to 7.5 prior lines of therapy and disease duration ranging from 0.5 to 40 years.

Budoprutug was generally well tolerated at both the 250 mg and 500 mg dose levels, with no serious adverse events, no treatment discontinuations due to adverse events, and no infusion related reactions; all adverse events were Grade 1 to Grade 2.

In the 250 mg dose cohort, B-cell levels were depleted by an average of over 90% by Week 4 and mean platelet count increased by 111,000 platelets/µL at Week 24.

Durable platelet responses were achieved in four out of six patients in the 250 mg dose cohort, with two out of six patients experiencing platelet levels ≥100 x 10³/µL for over 24 weeks.

Of the four patients who had previously been treated with rituximab, three responded to treatment with budoprutug, two with durable and complete responses.

Results to date support continued clinical evaluation of budoprutug in ITP; enrollment in the 1000 mg cohort is ongoing.