TaiMed Biologics Inc. submitted a revised clinical study protocol to the U.S. FDA in early October 2023 to evaluate the safety and efficacy of the TMB-365/380 combination in 40 patients core group of the Phase 2 clinical study. The FDA did not raise any concern within the mandatory 30-day calendar review period, and TaiMed issued the press release for the event. The company recently received a letter from the U.S. FDA providing valuable suggestions regarding the company's plan to conduct the aforementioned clinical trials.

To ensure the success of the effectiveness of Phase III clinical trials in the future, the company has decided to adopt the opinions of the US FDA after evaluation. TaiMed plans to adjust to prioritize the implementation of a 20 patients core group of the 2a clinical trial (24 weeks), all of which will be administered bi-monthly dosing, and then conduct a 2b clinical trial (48 weeks) with an appropriate number of patients. The TMB-365/380 combination phase 2a clinical trial will be accelerated and is expected to be completed by the end of 2024, and the phase 2b clinical trial will continue.

The interim analysis results will be used to evaluate whether there is an opportunity to start the phase 3 clinical trial early in the second half of 2026. The Phase II revised clinical trial design will not affect the current TaiMed fundraising (total funds, funding sources, plan projects), the 2024 company budget, financial revenues and expenditures. Only the estimated fundraising utilization progress and the expected benefits related to the period from 2025 Second Quarter to 2026 fourth quarter will be slightly revised in line with the revised clinical plan.