Highlights Summary:
TaiMed Biologics has established a comprehensive short-, medium-, and long-term innovative R&D project framework. Additionally, with the FDA inspection of the Zhubei facility with zero deficiency, CDMO revenue generation has commenced.

Short-Term:
Trogarzo has generated positive operating cash flow. The licensing in the Middle East, North Africa, Hong Kong, Macau, and Taiwan is set to drive revenue growth starting in 2025. 
In early 2024, exclusive sales and marketing agreements were signed with AcedrA, Wuzhou Drug, and OEP Group in the Middle East, North Africa, Hong Kong, Macau, and Taiwan regions, respectively. These partnerships are expected to positively impact TaiMed’s overall profitability and long-term value, with significant revenue growth anticipated from 2025 onwards. TaiMed continues to seek potential partners in additional regions to expand Trogarzo sales.

Medium-Term:
The long-acting TMB-365/380 combination is targeted as a complete regimen for frontline therapy. The research focus will extend to dosage forms for self-administration at home, increasing treatment convenience.
Phase 1b clinical results were presented at the CROI conference, drawing significant attention from major pharmaceutical companies and the medical community in the field of HIV. This project entered Phase 2a clinical research earlier this year, and all patients completed the first dosing in early May. Preliminary data is expected to be available by the end of 2024 or early 2025. If the results meet expectations, the Phase 2b clinical trial is projected to begin in 2025, with continued discussions for licensing and collaboration with major pharmaceutical companies.

HIV treatment is trending towards long-acting injection and self-administration at home. TMB-365/TMB-380 offers advantages over existing products like Cabenuva and other long-acting therapies in terms of antiviral coverage, reducing resistance risks, minimizing potential side effects, simplifying treatment, and providing greater therapeutic flexibility. Given the unique approach of TMB-365/380, in treating severe diseases and filling unmet medical needs, the US FDA granted Fast Track designation in February 2024.

Long-Term: Forward-Looking ADC Development Plan
TMB-365 has high binding specificity to CD4 cells, making it an ideal carrier for antiretroviral drugs. TaiMed's ADC (antibody-drug conjugate) is made up of a monoclonal antibody with high specificity for binding to CD4 cells and anti-HIV entry inhibitor activity. When attached to CD4 cells, the ADC is internalized and releases the antiretroviral drug payload to inhibit viral replication. Compared to ADCs used in cancer treatment, TaiMed’s ADC technology has a dual action—acting both as a carrier for the antiretroviral drug and as an effective HIV entry inhibitor.

CDMO Business: 
In 2023, CDMO revenue reached approximately NTD 30 million. Currently, discussions are ongoing with several potential customers, and more CDMO revenue is expected in 2024. TaiMed’s cGMP protein production facility in Zhubei successfully passed US FDA audits with zero deficiency in 2022 and 2023, further demonstrating our commitment to GMP quality and standards.

Latest Company Operating Performance:
The financial report for the first quarter of fiscal year 2024 shows operating revenue of NTD 179 million, a year-on-year increase of approximately 1.5 times compared to NTD 72 million last year. The net loss for this period was NTD 16.04 million, an approximate 80% reduction compared to the net loss of NTD 80.8 million last year. The net loss per share was NTD 0.06, significantly reduced from the NTD 0.32 net loss per share in the same period last year. This quarter's operations are close to breakeven. The cash flow statement for the first quarter shows a net cash inflow from operating activities of NTD 27.39 million, indicating positive operating cash flow.

To support Phase 2 research and prepare for the pivotal Phase 3, the company completed a cash capital increase in the first quarter of 2024, raising NTD 1.64 billion, increasing the net asset value per share to NTD 15.42. This move not only significantly improves the financial structure but also positions the company for future licensing negotiations.

Summary:
On the business side, combining Trogarzo sales and CDMO business expansion, revenue has steadily grown and is approaching profitability. On the R&D front, positive Phase 2 research results are expected to unlock licensing and co-development opportunities. The development of the forward-looking ADC program could revolutionize the ultimate HIV treatment and even the cure for HIV. These exciting operational achievements are poised to maximize value for TaiMed shareholders.