Yang Chun-yao, Chief Operating Officer of Taiwan Bio Therapeutics Co., Ltd., stated on the 28th that this year, the CDMO business in cellular therapy has the opportunity to add clients from Europe, Japan, and other regions, driving continuous revenue growth. Furthermore, the company will vigorously advance clinical trials for new drugs targeting gene-modified cells for lower limb ischemia, knee osteoarthritis, and anti-organ rejection, aiming to submit an IPO application by the end of this year to facilitate subsequent international business expansion.
Taiwan Bio Therapeutics held a board meeting on the 28th to address plans for listing and to reserve operational development funds. Resolutions included conducting a public offering of new shares during a rights issue, where existing shareholders will relinquish all preferential subscription rights. Additionally, the date of the shareholders' meeting will be brought forward for a comprehensive election of directors, and several important proposals, including the issuance of private placement common shares, were approved. During the shareholders' meeting scheduled for June 19th, Taiwan Bio Therapeutics will conduct an early election for all seven director seats, with three of them being independent directors.
Taiwan Bio Therapeutics achieved a record high consolidated revenue of NT$854.7 million last year, representing a year-on-year increase of 91%, primarily driven by significant growth in CDMO orders from international clients. Overseas revenue accounted for more than 50% of the total. However, due to the company's new drug products still being in the clinical development stage, it incurred a net loss of NT$217.51 million last year, with a loss per share of NT$3.81.
Looking ahead to this year, Yang Chun-yao stated that in addition to the potential addition of clients from Europe, Japan, and other regions in the CDMO business, which will drive continued revenue growth, the company will also focus on advancing clinical trials for new products targeting lower limb ischemia gene-modified cells, knee osteoarthritis, and anti-organ rejection. These development projects are being jointly developed with top research institutions in Taiwan and the United States. For example, the gene-modified cell therapy for lower limb ischemia, MSC-VEGF, developed in collaboration with the University of California, Davis (UC Davis), is expected to submit Phase I clinical trial applications to the FDA and TFDA in the second quarter.
Additionally, the anti-organ rejection drug TregCel (TRK-001), developed in partnership with U.S. partner TRACT Therapeutics, will jointly announce the design of Phase II clinical trials at the American Transplant Congress (ATC) in early June. Recruitment for trials in Taiwan and the United States is expected to begin in the third quarter, with a total of 34 patients enrolled. Analysis of major efficacy indicators will be conducted one year after the last patient is enrolled. TRK-001 has obtained orphan drug designation for solid organ transplantation rejection from the FDA, allowing it to accelerate market entry through the orphan drug regulatory pathway in the future.
To expand clinical trial recruitment and international market expansion, the board passed a resolution to issue new shares through private placement within a quota of 30 million shares and will seek authorization from the shareholders' meeting for the board to proceed based on market conditions and company operations.
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