• After a scheduled interim analysis of the severe babesiosis study on October 1, 2026, the DSMB recommended completing the study with the originally planned number of patients (N=33); the study remains blinded
  • As of the same date, the Company had enrolled 30 patients
  • Given the limited incremental statistical power from enrolling three additional patients and the seasonal nature of babesiosis, which would otherwise delay unblinding until fall 2027, the Company has decided to conclude enrollment and proceed with unblinding. Primary and secondary endpoint results are expected in January 2027
  • No safety signals were identified in the study
  • Published case reports and the Company’s prospective expanded access study support the potential of tafenoquine-containing regimens in treatment-refractory, relapsing babesiosis, and additional data will be disclosed from this study in early November 2026
  • Company sees a viable regulatory pathway for severe and/or treatment-refractory disease and will request a pre-sNDA meeting with FDA in January 2027 to discuss data requirements, patient population, regulatory pathway, and post-marketing requirements