Thor Medical (TRMED) PARADIGME Update summary

PARADIGME trial

• Phase 2b PARADIGME discontinued after independent data review; no further patients will be enrolled, following 109 total enrollments.

• Betalutin at 40/15 dose retained an attractive safety profile and showed efficacy in some patients, but only one in three responded, with average response duration of ~6 months.

• Board judged the profile insufficient to meet trial objectives or support commercially viable development in 3L relapsed and refractory follicular lymphoma.

• Trial wind-down to be structured to maintain the best possible patient care.

Betalutin development options

• Potential future development would target a different patient population and treatment line; partnership opportunities will be explored and FDA advice sought on alternative settings.

• Betalutin’s safety profile, promising efficacy in earlier treatment lines and one-time-dose administration were cited as potential advantages.

Pipeline and restructuring

• Development focus shifts to Humalutin, Alpha37, fully humanized anti-CD37 antibodies and a CD37 DOTA CAR-T opportunity developed with the University of Pennsylvania.

• Alpha37 is being explored with OranoMed for relapsed/refractory chronic lymphocytic leukaemia.

• Immediate restructuring planned to reduce costs and support essential pipeline-development activities.