Our Key Product AN1004 (pelareorep), with fast track designation from the FDA, is a registrational trial-stage, potential first-in-class intravenously delivered oncolytic virus for treating HR+/HER2- mBC.

AN1004 is also the clinically most advanced intravenous oncolytic virus that has completed a Phase II clinical trial and its safety profile has been proven in clinical trials with over 1,000 patients.

Phase II studies have shown an approximate doubling of OS in HR+/HER2-mBC patients who received AN1004. We received the approval from the NMPA in February 2019 for our initiation of an open-label, randomized, multi-center, Phase III clinical trial for AN1004 in combination with paclitaxel in patients with HR+/HER2-mBC. We initiated a bridging trial in China in March 2021 to assess the safety and tolerability of AN1004 in combination with paclitaxel for the Chinese patient population with HR+/HER2- mBC. We plan to initiate Phase III clinical trials in China in the first half of 2022.