Financial Performance - Other income increased from approximately RMB 10.5 million for the year ended December 31, 2023, to approximately RMB 33.8 million for the year ended December 31, 2024, representing a growth of about 220.4%[3]. - Net loss from other gains and losses decreased from approximately RMB 106.5 million for the year ended December 31, 2023, to approximately RMB 11.8 million for the year ended December 31, 2024, a reduction of about 88.9%[3]. - Loss before tax decreased from approximately RMB 335.5 million for the year ended December 31, 2023, to approximately RMB 186.4 million for the year ended December 31, 2024, a decrease of about 44.4%[3]. - Total loss and comprehensive expenses decreased from approximately RMB 335.5 million for the year ended December 31, 2023, to approximately RMB 187.3 million for the year ended December 31, 2024, a reduction of about 44.2%[4]. - The total loss for the year ended December 31, 2024, was RMB 187.3 million, compared to RMB 335.5 million for the year ended December 31, 2023[38]. - The company reported a net loss of RMB 187,343,000 for the year ending December 31, 2024, compared to a net loss of RMB 335,479,000 in the previous year, indicating an improvement[97]. - The group reported a net loss attributable to shareholders of RMB 186,912,000 for the year ended December 31, 2024, compared to a loss of RMB 334,819,000 in 2023, indicating an improvement of approximately 44%[129]. Research and Development - R&D expenses decreased from approximately RMB 177.3 million for the year ended December 31, 2023, to approximately RMB 154.2 million for the year ended December 31, 2024, a decline of about 13.0%[3]. - The company has completed the enrollment of 430 target patients for the Phase II clinical trial of EAL®, with the application for conditional approval submitted to the NMPA[5]. - The company has completed the enrollment of six target patients for the Phase I clinical trial of 6B11-OCIK injection and is conducting preliminary analysis of the trial results[6]. - CAR-T-19 injection has received breakthrough therapy designation for the treatment of patients aged 25 and under with relapsed/refractory B-ALL, expediting its clinical development[8]. - The company has completed the enrollment of 12 target patients for the Phase I clinical trial of Dinolones injection[9]. - The company has multiple TCR-T cell products in preclinical research targeting indications such as renal cell carcinoma and viral infections like CMV and EBV[12]. - The YT007 injection for treating advanced renal cell carcinoma has completed preclinical research[13]. - The core candidate product EAL® has received acceptance for its NDA from the NMPA, with a focus on preventing postoperative recurrence of liver cancer[14][19]. - The company has established a technical platform necessary for the development of cell immunotherapy products[15]. - The company has established a virus vector production system that meets GMP standards, enabling large-scale production of viral vectors for CAR-T cell enterprises[36]. - The company aims to continue investing in CAR-T and TCR-T cell product pipelines, targeting CMV infections in patients post-transplant[34]. - The company is focused on the research and development of new drugs, particularly in the field of immune cell therapy[151]. Financial Management - Cash and bank balances decreased from approximately RMB 52.2 million as of December 31, 2023, to RMB 47.0 million as of December 31, 2024, primarily due to cash used in R&D[52]. - The liquidity ratios showed a decline, with the current ratio decreasing from 0.40 in 2023 to 0.20 in 2024, and the quick ratio decreasing from 0.39 to 0.19 during the same period[63]. - The company has no interest-bearing debt as of December 31, 2024, making the debt-to-equity ratio not applicable[67]. - The company aims to enhance its operational capital and financial condition through the issuance of convertible bonds, despite potential dilution effects on existing shareholders[58]. - The company has significant uncertainties regarding its ability to continue as a going concern due to ongoing losses and cash flow issues[94]. - The group has significant uncertainty regarding its ability to continue as a going concern, dependent on the successful implementation of its plans and measures[113]. - The company has received recognition as a "High-tech Enterprise," allowing it to benefit from a reduced corporate income tax rate of 15%[122]. Employee and Operational Costs - Employee compensation for the year totaled approximately RMB 70.1 million, down from RMB 77.0 million in 2023[75]. - Total employee costs for 2024 are RMB 70,053,000, down from RMB 77,034,000 in 2023, reflecting a decrease of approximately 9.5%[127]. - The company employed a total of 154 employees as of December 31, 2024[76]. - The quality department had 39 employees as of December 31, 2024, and reports directly to the CEO[32]. Capital and Investment - The company issued convertible bonds totaling RMB 300 million on February 20, 2023, with an initial conversion price of HKD 4.81 per share[57]. - The company raised a total of RMB 300 million through the issuance of convertible bonds, with RMB 102.3 million allocated for EAL® clinical trials and RMB 197.7 million for the construction of a new R&D and production center[60]. - As of December 31, 2024, the company utilized approximately RMB 240.2 million of the funds raised from the convertible bonds, with RMB 102.3 million fully used for EAL® clinical trials and RMB 154.3 million used for the new R&D center[61]. - The company plans to invest approximately RMB 1.2 billion in the Beijing production center, expected to produce over 200,000 batches of cell drugs annually[30]. - A project in the East China region is expected to have a total investment of around RMB 1 billion, with the first phase of the EAL® R&D and production center to be completed within 48 months after obtaining land ownership[30]. Compliance and Governance - The audit committee has confirmed compliance with applicable accounting principles and standards for the financial year ending December 31, 2024[90]. - Deloitte has agreed that the preliminary announcement figures align with the audited consolidated financial statements to be approved on March 31, 2025[91]. - The company has adopted the standards set forth in the listing rules to regulate securities trading by directors and related employees[86]. - The company is focused on ensuring compliance with the listing rules of the Hong Kong Stock Exchange[151]. Future Outlook - The company plans to accelerate the commercialization of EAL® and is focusing on government affairs, hospital admissions, market, medical, and sales-related work[33]. - The company is actively seeking equity financing and applying for applicable government subsidies[112]. - The company is exploring market expansion opportunities in the biopharmaceutical sector[152]. - The company plans to fully utilize the net proceeds by 2025[72].
永泰生物-B(06978) - 2024 - 年度业绩