永泰生物(06978) - 2025 - 中期业绩

Interim Performance Summary Financial Summary The company experienced significant other income growth but a substantial increase in loss and total comprehensive expense due to fair value losses on other financial liabilities, expanding loss per share Financial Performance Highlights (RMB thousands) | Metric | 2025 (RMB thousands) | 2024 (RMB thousands) | Change (%) | | :--- | :--- | :--- | :--- | | Other income | 13,036 | 6,526 | 99.8 | | Net other gains and losses | (51,045) | 19,836 | (357.3) | | Administrative expenses | (19,643) | (23,048) | (14.8) | | Research and development expenses | (67,449) | (91,118) | (26.0) | | Finance costs | (3,350) | (3,851) | (13.0) | | Other expenses | (579) | (901) | (35.7) | | Loss before tax | (129,030) | (92,556) | 39.4 | | Loss and total comprehensive expense for the period | (129,032) | (92,556) | 39.4 | | Loss attributable to owners of the Company | (129,103) | (92,515) | 39.5 | | Basic and diluted loss per share | (0.25) | (0.18) | - | Financial Position Highlights (RMB thousands) | Metric | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | Change (%) | | :--- | :--- | :--- | :--- | | Non-current assets | 448,136 | 476,548 | (6.0) | | Current assets | 40,763 | 87,494 | (53.4) | | Current liabilities | (496,539) | (430,206) | 15.4 | | Net current liabilities | (455,776) | (342,712) | 33.0 | | Non-current liabilities | (137,845) | (150,289) | (8.3) | | Net liabilities | (145,485) | (16,453) | 784.2 | Company Overview Overview Yongtai Biological Pharmaceutical Co Ltd is a leading T-cell immunotherapy biopharmaceutical company in China, with nearly 18 years of R&D and commercialization experience - The company is a leading cell immunotherapy biopharmaceutical company in China, focusing on T-cell immunotherapy R&D and commercialization for nearly 18 years[5] - The conditional NDA for the core pipeline product EAL® is currently under review by the CDE of NMPA[6] - The product pipeline covers non-genetically modified and genetically modified products, with key pipeline products including EAL®, 6B11, CAR-T cell series, and TCR-T cell series[6] Management Discussion and Analysis Business Review The Group advanced multiple cell immunotherapy pipeline products' clinical trials, including EAL®'s NDA review, 6B11-OCIK Injection's Phase I completion, and CAR-T-19 Injection's Phase II enrollment and breakthrough therapy designation, while also developing R&D and production centers with stringent quality assurance - The conditional NDA for the core candidate product EAL® is under review by the CDE of NMPA and was included in China's priority review and approval list in March 2025[6][11] - CAR-T-19 Injection completed Phase II clinical trial enrollment for 52 target patients and received breakthrough therapy designation from the CDE, which will accelerate clinical development[14][15] - The Group plans to build R&D and production centers in Beijing, Shaoxing, and Shanghai to support pipeline product clinical R&D and future commercialization needs, with an estimated annual production capacity exceeding 200,000 batches[21][22] R&D of Pipeline Products The Group's pipeline covers non-genetically modified products (e.g., EAL®, 6B11) and genetically modified products (e.g., CAR-T, TCR-T series), targeting various solid tumors, hematological malignancies, and post-transplant infections, with several products in clinical trial stages Pipeline Products Overview | Product Category | Product Code | Therapeutic Area | Indication | Clinical Stage | | :--- | :--- | :--- | :--- | :--- | | Non-genetically modified products | EAL® | Solid tumors | Post-operative hepatocellular carcinoma, post-operative gastric cancer | NDA under review | | Non-genetically modified products | 6B11 | Platinum-resistant ovarian cancer (OC) | Platinum-resistant ovarian cancer (OC) | Phase I enrollment completed | | Genetically modified products | CAR-T-19 | Hematological malignancies | Relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in patients under 25 | Phase II enrollment completed | | Genetically modified products | Dinolunsa Injection | Hematological malignancies | Relapsed or refractory diffuse large B-cell lymphoma | Phase I enrollment completed | | Genetically modified products | YT003 | Post-transplant infection | CMV infection after hematopoietic stem cell transplantation | Preclinical research | | Genetically modified products | YT007 | Solid tumors | Clear cell renal cell carcinoma (ccRCC) | Preclinical research largely completed | - The company cautions that its pipeline products, including core pipeline products, may not ultimately be successfully developed and commercialized[9] EAL® EAL®, a broad-spectrum anti-tumor cell immunotherapy product, has over a decade of clinical application experience in cancer treatment, completed Phase II enrollment for 430 patients, received CDE approval for conditional NDA submission, and was granted priority review in China, with NDA currently under review - EAL® is a broad-spectrum anti-tumor cell immunotherapy product with over ten years of clinical application experience in cancer treatment[10] - Enrollment for 430 target patients in the Phase II clinical trial has been completed[11] - The CDE has approved the submission of EAL®'s conditional approval application, included it in China's priority review and approval list, and the NDA is currently under review[11] 6B11-OCIK Injection 6B11-OCIK Injection, an autologous cytotoxic T lymphocyte injection for ovarian cancer, has completed Phase I enrollment for six target subjects, with preliminary analysis and interim results underway, and Phase II clinical trials planned for an opportune time - 6B11-OCIK Injection is an autologous cytotoxic T lymphocyte injection for ovarian cancer, utilizing 6B11 to induce specific anti-ovarian cancer immune responses[12] - Enrollment for six target subjects in the Phase I clinical trial has been completed, with preliminary analysis and interim results currently underway[12] - The Group plans to initiate Phase II clinical trials at an appropriate time based on business arrangements[12] CAR-T Cell Product Pipeline The CAR-T cell product pipeline, centered on the CAR-T-19 series, includes CAR-T-19 Injection, which received breakthrough therapy designation and completed Phase II enrollment for 52 patients, while Dinolunsa Injection and aT19 Injection aim to address CAR-T treatment durability and recurrence issues, with Dinolunsa completing Phase I enrollment and aT19 receiving Phase I IND approval - CAR-T-19 Injection is indicated for B-ALL patients under 25 years old and has been granted breakthrough therapy designation by the CDE, which will accelerate its clinical development[14] - Enrollment for 52 target patients in the CAR-T-19 Injection Phase II clinical trial has been completed[15] - Dinolunsa Injection and aT19 Injection aim to address the challenges of insufficient durability, suboptimal efficacy, and tumor recurrence in CAR-T cell therapy; Dinolunsa has received implied clinical approval and completed Phase I enrollment, while aT19 has received Phase I IND approval[16][18] TCR-T Cell Product Pipeline The Group's TCR-T cell product pipeline focuses on tumor antigen-specific T cell adoptive immunotherapy, having established a single-cell sequencing platform, with multiple TCR-T pipeline products in preclinical research for clear cell renal cell carcinoma, CMV, and EBV infections, including TCR-T-CMV Injection completing preclinical communication and YT007 Injection largely completing preclinical research - TCR-T cell therapy is an immunotherapy based on tumor antigen-specific T cell adoptive transfer, and the Group has established a technology platform centered on single-cell sequencing[19] - Multiple TCR-T cell pipeline products are currently undergoing preclinical research, targeting clear cell renal cell carcinoma, CMV, and EBV viral infections[19] - TCR-T-CMV Injection for refractory CMV infection after hematopoietic stem cell transplantation completed preclinical communication in April 2025, and YT007 Injection for advanced clear cell renal cell carcinoma has largely completed preclinical research[19][20] Group Facilities The Group operates an R&D and production center in Beijing spanning approximately 27,604 square meters and plans to establish new R&D and production centers in North China (Beijing) and East China (Shaoxing, Shanghai) to expand EAL®'s distribution radius, accelerate clinical trials, and meet future commercialization needs, with a total estimated investment of RMB 2.2 billion - The Group's R&D and production center in Beijing, China, covers approximately 27,604 square meters, supporting preclinical and clinical R&D, as well as early-stage production needs for pipeline products[21] - Plans include investing approximately RMB 1.2 billion in North China (Beijing) to build an R&D and industrialization base, with an estimated annual production capacity exceeding 200,000 batches[21] - The Group plans to establish an EAL® R&D and production center in East China (Shaoxing, Shanghai), with an expected total investment of approximately RMB 1 billion, and construction of the Shaoxing production center has commenced[21][22] Quality Assurance The Group has developed quality management documents in accordance with GMP standards, covering the entire production process to ensure product compliance with relevant laws, regulations, and GMP requirements, with EAL® production standardized and quality issues recorded for senior management review, supported by a 43-member quality department reporting directly to the CEO - The Group has developed quality management documents in accordance with GMP, covering production process procedures, product quality standards, equipment and facility operating procedures, to ensure full compliance with relevant laws, regulations, and GMP requirements[23] - EAL® production has been standardized, and comprehensive production process standards have been established to ensure consistent product quality[23] - The quality department comprises 43 employees who report directly to the Chief Executive Officer, with two sub-teams for quality assurance and quality control[24] Future and Outlook The Group plans to accelerate EAL®'s commercialization, advance post-listing preparations, continue investing in preclinical research for CAR-T and TCR-T pipelines, enhance its technology platform to enrich the product pipeline, develop viral vector production and CDMO services, and expand strategic collaborations and explore M&A opportunities based on organic growth - Plans include fully advancing EAL®'s post-listing commercialization preparations, encompassing government affairs, hospital access, marketing, medical, and sales-related work[25] - The Group will continue to invest in preclinical research for CAR-T and TCR-T cell product pipelines, particularly for treating viral infections such as CMV[26] - The company is committed to enhancing its technology platform, establishing a TCR gene database targeting tumor neoantigens, and developing GMP-compliant viral vector production and CDMO services[27][28] - Building on organic growth, the Group plans to expand strategic collaborations, seek sales, technology transfer, and strategic partnerships for existing and pipeline products, and explore M&A opportunities[29] Financial Information Financial Review For the six months ended June 30, 2025, the Group reported a loss before tax of RMB 129.0 million, a 39.4% increase year-on-year, driven by a 99.8% rise in other income due to government grants but offset by a swing from gain to loss in net other gains and losses due to fair value losses on financial liabilities, while administrative and R&D expenses decreased, finance costs reduced, and income tax expense remained minimal due to a 15% preferential tax rate for high-tech subsidiaries in China Financial Performance Summary (RMB thousands) | Metric | 2025 (RMB thousands) | 2024 (RMB thousands) | Change (%) | | :--- | :--- | :--- | :--- | | Other income | 13,036 | 6,526 | 99.8 | | Net other gains and losses | (51,045) | 19,836 | (357.3) | | Administrative expenses | (19,643) | (23,048) | (14.8) | | Research and development expenses | (67,449) | (91,118) | (26.0) | | Finance costs | (3,350) | (3,851) | (13.0) | | Loss before tax | (129,030) | (92,556) | 39.4 | | Loss and total comprehensive expense for the period | (129,032) | (92,556) | 39.4 | - Other income increased by 99.8% to RMB 13.0 million, primarily due to increased government grants for subscription funds incentives[32] - Net other gains and losses swung from a gain of RMB 19.8 million to a loss of RMB 51.0 million, mainly due to fair value losses on other financial liabilities[34] - Research and development expenses decreased by 26.0% to RMB 67.4 million, primarily due to lower contract costs, staff costs, and R&D project material costs[36] - Beijing Yongtai and Yongtai Ruike, as high-tech enterprises, enjoyed a preferential corporate income tax rate of 15% during the reporting period[41][73] Liquidity and Capital Resources The Group's bank balances and cash decreased from RMB 47.0 million at the end of 2024 to RMB 21.1 million as of June 30, 2025, primarily due to daily operating expenses, with lease liabilities of approximately RMB 111.7 million and no other significant outstanding debt or contingent liabilities, though convertible bonds are secured by asset and share mortgages - Bank balances and cash decreased from RMB 47.0 million as of December 31, 2024, to RMB 21.1 million as of June 30, 2025, primarily due to daily operating expenses[42] - As of June 30, 2025, lease liabilities were approximately RMB 111.7 million, secured by lease deposits and unsecured[43] - Convertible bonds are secured by land use rights, other pledged assets (including certain equipment and financial assets at fair value through profit or loss), and shares held by Tan Zheng Ltd and Tan Yue Yue Ltd[44] Share Capital Structure The Company's shares were listed on the Main Board of the Stock Exchange on July 10, 2020, with 100,000,000 shares issued through a global offering; as of June 30, 2025, total issued share capital was USD 514,584, divided into 514,584,000 shares, reflecting a significant increase in net liabilities and a deteriorating debt-to-equity ratio - Shares were listed on the Main Board of the Stock Exchange on July 10, 2020, with 100,000,000 shares issued through a global offering[46] - As of June 30, 2025, the Company's total issued share capital was USD 514,584, divided into 514,584,000 shares[46] Debt-to-Equity Ratio | Metric | June 30, 2025 | June 30, 2024 | | :--- | :--- | :--- | | Debt | 129.0% | 89.1% | | Equity | -29.0% | 10.9% | Issuance of Convertible Bonds under Specific Mandate In February 2023, the Company issued convertible bonds with a principal amount of RMB 300.0 million to Tasly for pipeline operations, R&D, and product commercialization; as of June 30, 2025, all proceeds were fully utilized, primarily for EAL® clinical trials and new R&D and production center construction, with the bonds transferred to an independent third party on July 15, 2025 - On February 20, 2023, the Company issued convertible bonds with a total principal amount of RMB 300.0 million to Tasly, with an initial conversion price of RMB 4.38 per share[47] - The issuance of convertible bonds aimed to raise funds for pipeline operations, R&D, and product commercialization, as well as to enhance working capital and financial position[48] Use of Proceeds from Convertible Bonds (RMB millions) | Use of Proceeds | Allocated Amount (RMB millions) | Amount Utilized as of June 30, 2025 (RMB millions) | | :--- | :--- | :--- | | EAL® clinical trials | 102.3 | 102.3 | | Construction costs for new R&D and production centers | 197.7 | 197.7 | | Total | 300.0 | 300.0 | - As of June 27, 2025, all preconditions for the transfer of the convertible bonds were met, and the transfer was completed on July 15, 2025[50] Foreign Exchange The Group primarily operates in China, facing foreign exchange risk from Renminbi fluctuations against other currencies, mainly Hong Kong Dollars, and manages this risk by closely monitoring and minimizing net foreign exchange positions, without engaging in any currency hedging transactions during the reporting period - The Group primarily operates in China and faces foreign exchange risk arising from various currency exposures, mainly from Hong Kong Dollars[51] - The Group seeks to limit its foreign exchange risk exposure by closely monitoring and minimizing net foreign exchange positions[51] - During the reporting period, the Group did not enter into any currency hedging transactions[51] Selected Financial Ratios The Group's current and quick ratios significantly decreased from the end of 2024 to June 30, 2025, primarily due to a reduction in financial assets at fair value through profit or loss and an increase in other financial liabilities, while the debt-to-asset ratio changed from zero at the end of 2024 to 0.14 as of June 30, 2025, reflecting increased liabilities Key Financial Ratios | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Current Ratio | 0.08 | 0.20 | | Quick Ratio | 0.07 | 0.19 | | Debt-to-Asset Ratio | 0.14 | – | - The decrease in current and quick ratios was primarily due to a reduction in financial assets at fair value through profit or loss from RMB 10.5 million to zero, and an increase in other financial liabilities from RMB 268.1 million to RMB 318.6 million[54] Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income This section presents the condensed consolidated statement of profit or loss and other comprehensive income for the six months ended June 30, 2025, and the corresponding period in 2024, detailing the Group's revenue, various expenses, loss before tax, income tax expense, and total comprehensive expense for the period, disaggregated by owners of the Company and non-controlling interests - For the six months ended June 30, 2025, the loss for the period attributable to owners of the Company was RMB 129,103 thousand, an increase from RMB 92,515 thousand in the corresponding period of 2024[55] - Both basic and diluted loss per share were RMB (0.25), higher than RMB (0.18) in the corresponding period of 2024[55] Condensed Consolidated Statement of Financial Position This section provides the condensed consolidated statement of financial position as of June 30, 2025, and December 31, 2024, detailing the Group's non-current assets, current assets, current liabilities, non-current liabilities, net liabilities, and capital and reserves, reflecting a trend of deteriorating liquidity and increasing liabilities - As of June 30, 2025, the Group recorded net current liabilities of RMB 455,776 thousand, a significant increase from RMB 342,712 thousand as of December 31, 2024[56] - As of June 30, 2025, the Group's net liabilities were RMB 145,485 thousand, compared to RMB 16,453 thousand as of December 31, 2024, indicating a significant deterioration in its liability position[57] - The deficit attributable to owners of the Company significantly expanded to RMB 142,399 thousand as of June 30, 2025, from RMB 13,296 thousand as of December 31, 2024[57] Notes to the Condensed Consolidated Financial Statements This section provides detailed notes to the condensed consolidated financial statements, covering the company's general information, basis of preparation (including going concern assessment and related uncertainties), accounting policies, segment information, composition of various income and expenses, loss per share calculation, prepayments, financial assets, payables, government grants, other financial liabilities (convertible bonds), and specific disclosures on other borrowings - For the six months ended June 30, 2025, the Group incurred a loss of RMB 129,032,000 and net cash outflows from operating activities of RMB 45,169,000, along with net current liabilities of RMB 455,776,000 and net liabilities of RMB 145,485,000, raising significant doubts about its ability to continue as a going concern[61] - The company has formulated several plans to improve liquidity, including equity financing, convertible bond extension, additional financial support from shareholders, management payment schedules, bank borrowings, and government subsidies, but the success of these plans remains subject to significant uncertainties[61][62][65][66] - The fair value of convertible bonds within other financial liabilities changed from RMB 268,097 thousand as of January 1, 2025, to RMB 318,590 thousand as of June 30, 2025, resulting in a fair value change loss of RMB 50,493 thousand[88] General Information Yongtai Biological Pharmaceutical Co Ltd, incorporated in the Cayman Islands, had its ordinary shares listed on the Main Board of the Stock Exchange of Hong Kong since July 10, 2020, with its principal business being investment holding and its subsidiaries primarily engaged in the R&D, manufacturing, and commercialization of cancer cell immunotherapy products in China, and the condensed consolidated financial statements are presented in Renminbi - The Company was incorporated in the Cayman Islands on April 11, 2018, and its ordinary shares have been listed on the Main Board of the Stock Exchange of Hong Kong since July 10, 2020[58] - The principal business is investment holding, with subsidiaries primarily engaged in the research and development, manufacturing, and commercialization of cancer cell immunotherapy products in China[58] Basis of Preparation The condensed consolidated financial statements are prepared in accordance with IAS 34 and the Listing Rules, but the company faces significant going concern uncertainties due to losses, net operating cash outflows, net current liabilities, and net liabilities; while management has developed plans (e.g., equity financing, bond extension, shareholder support, payment management, bank borrowings, government subsidies) to improve liquidity, the success of these plans is highly uncertain, though directors deem the going concern assumption appropriate - The Group incurred a loss of RMB 129,032,000 and net cash outflows from operating activities of RMB 45,169,000 for the six months ended June 30, 2025[61] - As of that date, the Group had net current liabilities of RMB 455,776,000, net liabilities of RMB 145,485,000, and bank balances and cash of RMB 21,053,000, raising significant doubts about its ability to continue as a going concern[61] - The company has formulated several plans and measures to improve liquidity, including equity financing, convertible bond extension, additional financial support from shareholders, management payment schedules, bank borrowings, and government subsidies, but their success remains subject to significant uncertainties[61][62][65][66] Accounting Policies The condensed consolidated financial statements are prepared on a historical cost basis, except for certain financial instruments measured at fair value, with accounting policies and calculation methods applied in this interim period consistent with the 2024 annual consolidated financial statements, and the application of IFRS amendments having no significant impact on financial position or performance - The condensed consolidated financial statements have been prepared on a historical cost basis, except for certain financial instruments measured at fair value at the end of the reporting period[64] - The accounting policies and methods of computation applied in this interim period are consistent with those presented in the Group's annual consolidated financial statements for the year ended December 31, 2024[64] - The application of amendments to IFRS accounting standards had no significant impact on the Group's financial position and performance during this period and prior periods[67] Segment Information The Group operates as a single operating and reportable segment, thus no further segment analysis is presented; all non-current assets are located in China, and no revenue was recorded during the reporting period - The Group has only one operating and reportable segment, and no further analysis of this single segment is presented[68] - The Group did not record any revenue for the six months ended June 30, 2025[69] - All of the Group's non-current assets (excluding financial instruments) are located in China, amounting to RMB 445,028,000 as of June 30, 2025[69] Other Income The Group's other income increased by 99.8% from approximately RMB 6.5 million in the corresponding period of 2024 to RMB 13.0 million in 2025, primarily due to a significant increase in government grants for subscription funds incentives Other Income (RMB thousands) | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Income from providing cell cryopreservation services | 365 | 355 | | Income from providing technical services | 610 | 832 | | Interest income from bank balances and deposits | 283 | 381 | | Interest income from lease deposits | 99 | 97 | | Rental income from leased land | – | 229 | | Government grants - subscription funds incentives | 6,770 | – | | Government grants - machinery | 4,691 | 4,128 | | Government grants - R&D activities | 46 | 428 | | Government grants - others | 172 | 76 | | Total | 13,036 | 6,526 | - Government grants for subscription funds incentives increased from zero in 2024 to RMB 6,770 thousand in 2025, being the primary reason for the growth in other income[70] Net Other Gains and Losses The Group recorded a net other loss of RMB 51.0 million for the six months ended June 30, 2025, a swing from a gain of RMB 19.8 million in the corresponding period of 2024, primarily due to fair value losses on other financial liabilities, with the 2024 period also including a loss on termination of an intangible asset and impairment loss on prepayments Net Other Gains and Losses (RMB thousands) | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Fair value gains on financial assets at fair value through profit or loss | 65 | 3,323 | | Fair value (losses) gains on other financial liabilities | (50,493) | 41,048 | | Loss on termination of an intangible asset | – | (19,316) | | Impairment loss on prepayments to a supplier | – | (5,183) | | Exchange (losses) gains, net | (32) | 11 | | Gains (losses) on disposal of property, plant and equipment | 11 | (41) | | Others | (596) | (6) | | Total | (51,045) | 19,836 | - The fair value of other financial liabilities swung from a gain of RMB 41,048 thousand in 2024 to a loss of RMB 50,493 thousand in 2025, which was the main reason for the net loss[71] - The corresponding period in 2024 recorded a loss on termination of an intangible asset of RMB 19,316 thousand and an impairment loss on prepayments made to T-Cure of RMB 5,183 thousand[71] Income Tax Expense The Group's income tax expense for the six months ended June 30, 2025, was RMB 2 thousand, with Chinese subsidiaries Beijing Yongtai and Yongtai Ruike benefiting from a 15% preferential corporate income tax rate as high-tech enterprises, while the Hong Kong subsidiary had no tax provision due to no estimated taxable profits; the Group holds substantial unused tax losses but has not recognized deferred tax assets due to unpredictable future profit streams Income Tax Expense (RMB thousands) | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Current China corporate income tax | 2 | – | - Beijing Yongtai and Yongtai Ruike, as high-tech enterprises, enjoy a reduced corporate income tax rate of 15%[73] - As of June 30, 2025, the Group's estimated unused tax losses were approximately RMB 2,051,015,000, but no deferred tax assets were recognized[74] Loss for the Period This section details the composition of the loss for the period for the six months ended June 30, 2025, and the corresponding period in 2024, including staff costs, depreciation of property, plant and equipment, amortization of intangible assets, and raw materials and subcontracting costs included in R&D expenses Loss for the Period Components (RMB thousands) | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Total staff costs | 25,996 | 36,641 | | Depreciation of property, plant and equipment | 27,638 | 29,067 | | Amortization of intangible assets | 1,273 | 1,311 | | Cost of raw materials and other consumables included in R&D expenses | 2,925 | 9,829 | | Subcontracting costs included in R&D expenses | 15,430 | 25,664 | - Total staff costs decreased from RMB 36,641 thousand in 2024 to RMB 25,996 thousand in 2025[75] - Costs of raw materials and other consumables, as well as subcontracting costs included in R&D expenses, both significantly decreased[75] Dividends The Company's directors have decided not to declare any dividends for the interim period ended June 30, 2025 - No dividends were paid, declared, or proposed during the period[76] - The directors have decided not to pay any dividends for the interim period[76] Loss Per Share The calculation of basic and diluted loss per share attributable to owners of the Company is based on the loss for the period and the number of shares outstanding; no dilutive effect was included as the inclusion of share options and convertible bond conversions would result in a reduction in loss per share Loss Per Share (RMB thousands, except per share amount) | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Loss for the period attributable to owners of the Company | (129,103) | (92,515) | | Number of shares (thousands) | 514,584 | 514,584 | | Basic and diluted loss per share (RMB) | (0.25) | (0.18) | - For the purpose of calculating diluted loss per share, the conversion of share options and unexercised convertible bonds was not included, as their inclusion would result in a reduction in loss per share[78] Prepayments, Deposits and Other Receivables The Group's total prepayments, deposits, and other receivables decreased from RMB 23,708 thousand as of December 31, 2024, to RMB 19,060 thousand as of June 30, 2025, primarily comprising prepayments to suppliers and service providers, recoverable VAT, and lease deposits Prepayments, Deposits and Other Receivables (RMB'000) | Item | June 30, 2025 (RMB'000) | December 31, 2024 (RMB'000) | | :--- | :--- | :--- | | Prepayments to suppliers and service providers | 8,782 | 13,411 | | Recoverable VAT | 2,958 | 3,939 | | Prepayments for acquisition of property, plant and equipment | 1,035 | 1,029 | | Advances to employees | 1,539 | 706 | | Lease deposits | 3,474 | 3,375 | | Other deposits | 1,126 | 1,140 | | Others | 146 | 108 | | Total | 19,060 | 23,708 | - Prepayments to suppliers and service providers decreased from RMB 13,411 thousand to RMB 8,782 thousand[79] Financial Assets at Fair Value Through Profit or Loss The Group's financial assets at fair value through profit or loss were zero as of June 30, 2025, a significant decrease from RMB 10,536 thousand as of December 31, 2024, mainly due to the write-off of investments in certificates of deposit and the fair value of investments in Tasly Fund and Shaoxing Fund approaching zero due to target companies ceasing clinical research or convertible bonds being overdue Financial Assets at Fair Value Through Profit or Loss (RMB'000) | Item | June 30, 2025 (RMB'000) | December 31, 2024 (RMB'000) | | :--- | :--- | :--- | | Investment in Tasly Fund | – | – | | Investment in Shaoxing Fund | – | – | | Investment in certificates of deposit | – | 10,536 | | Total | – | 10,536 | - Investment in certificates of deposit was reduced to zero as of June 30, 2025, from RMB 10,536 thousand as of December 31, 2024[80] - The investment in Tasly Fund had its fair value approach zero due to the target company ceasing clinical research; the investment in Shaoxing Fund also had a fair value of zero due to overdue convertible bonds and the target company's poor financial condition[81][82] Trade and Other Payables The Group's total trade and other payables decreased from RMB 131,925 thousand as of December 31, 2024, to RMB 126,205 thousand as of June 30, 2025, with trade payables increasing while payables for property, plant and equipment acquisition and accrued salaries and other allowances decreased Trade and Other Payables (RMB'000) | Item | June 30, 2025 (RMB'000) | December 31, 2024 (RMB'000) | | :--- | :--- | :--- | | Trade payables | 40,354 | 33,609 | | Payables for acquisition of property, plant and equipment | 66,383 | 74,932 | | Accrued salaries and other allowances | 4,175 | 8,797 | | Payables for acquisition of intangible assets | 1,995 | 1,947 | | Payables for service expenses | 12,824 | 12,207 | | Others | 474 | 433 | | Total | 126,205 | 131,925 | - Trade payables increased from RMB 33,609 thousand to RMB 40,354 thousand, with trade payables aged over 3 years amounting to RMB 4,731 thousand[83] - Payables for acquisition of property, plant and equipment decreased from RMB 74,932 thousand to RMB 66,383 thousand[83] Deferred Government Grants The Group's total deferred government grants decreased from RMB 60,507 thousand as of December 31, 2024, to RMB 55,770 thousand as of June 30, 2025, primarily due to the release of grants related to machinery and R&D activities Deferred Government Grants (RMB'000) | Item | June 30, 2025 (RMB'000) | December 31, 2024 (RMB'000) | | :--- | :--- | :--- | | Current | – | 46 | | Non-current | 55,770 | 60,461 | | Total | 55,770 | 60,507 | Movement in Deferred Government Grants (RMB'000) | Item | Machinery (RMB'000) | R&D Activities (RMB'000) | Total (RMB'000) | | :--- | :--- | :--- | :--- | | As at January 1, 2025 | 60,461 | 46 | 60,507 | | Release of deferred government grants | (4,691) | (46) | (4,737) | | As at June 30, 2025 | 55,770 | – | 55,770 | Other Financial Liabilities The Group's other financial liabilities primarily consist of convertible bonds, whose fair value increased from RMB 268,097 thousand as of January 1, 2025, to RMB 318,590 thousand as of June 30, 2025, resulting in a fair value change loss of RMB 50,493 thousand; these bonds are secured by assets and were transferred after the reporting period Other Financial Liabilities (RMB'000) | Item | June 30, 2025 (RMB'000) | December 31, 2024 (RMB'000) | | :--- | :--- | :--- | | Convertible bonds | 318,590 | 268,097 | - The convertible bonds were issued in February 2023 with a principal of RMB 300 million, an annual interest rate of 6%, maturing within 3 years, and an initial conversion price of RMB 4.38 per share[87] - The convertible bonds are secured by certain property, plant and equipment, and financial assets at fair value through profit or loss of the Group, along with ordinary shares of the Company provided by Mr Tan Zheng and his close relatives[87] - The fair value of the convertible bonds was valued by an independent valuer using a binomial model, with a bond maturity of 0.64 years, volatility of 97.27%, and the Company's share price of RMB 2.56 as of June 30, 2025[89] Other Borrowings The Group incurred new other borrowings of RMB 20,038 thousand during the reporting period, including RMB 10 million from Ms Wei, a family member of Mr Tan Zheng, and RMB 10 million from an indirect shareholder of Tasly; these loans bear interest at an annual rate of 4.5% and are due one year after their respective receipt dates or upon completion of equity financing, whichever is earlier Other Borrowings (RMB'000) | Item | June 30, 2025 (RMB'000) | December 31, 2024 (RMB'000) | | :--- | :--- | :--- | | Other borrowings | 20,038 | – | - The Group borrowed RMB 10 million from Ms Wei, a family member of Mr Tan Zheng, on June 9, 2025, and RMB 10 million from an indirect shareholder of Tasly on June 20, 2025[92] - These loans bear interest at an annual rate of 4.5% and are due one year after their respective receipt dates or upon the completion date of equity financing, whichever is earlier[92] Other Information Interim Dividends The Company neither paid, declared, nor proposed any interim dividends during the reporting period - No dividends were paid, declared, or proposed during the reporting period[93] Use of Net Proceeds from Listing and Over-allotment Option The Company's net proceeds from the global offering and over-allotment option totaled approximately HKD 1,127.8 million, with approximately HKD 1,124.8 million utilized as of June 30, 2025, primarily for EAL® clinical trials and commercialization, CAR-T-19 and TCR-T series clinical trials, expanded EAL® R&D for other clinical indications, other pipeline product development, and working capital; the remaining proceeds are expected to be depleted by the end of 2025 - The net proceeds from the global offering and over-allotment option were approximately HKD 1,127.8 million[95] - As of June 30, 2025, the Company had utilized total proceeds of approximately HKD 1,124.8 million[95] Use of Net Proceeds (HKD millions) | Use of Proceeds | Allocation Percentage (%) | Amount Utilized as of June 30, 2025 (HKD millions) | | :--- | :--- | :--- | | Investment in EAL® clinical trials and commercialization | 34.2 | 385.6 | | R&D expenses for expanding EAL®'s other clinical indications | 18.9 | 212.5 | | Investment in CAR-T-19 and TCR-T series clinical trials | 33.2 | 374.5 | | Development of other pipeline products and construction of new R&D/production centers | 8.7 | 95.8 | | Working capital and other general corporate purposes | 5.0 | 56.4 | | Total | 100.0 | 1,124.8 | - The Company expects the net proceeds to be fully utilized by the end of 2025[97] Material Investments, Acquisitions and Disposals As of the date of this announcement, the Group held no material investments and had no future plans regarding material investments or capital assets - As of the date of this announcement, the Group held no material investments, nor did it have any future plans regarding material investments or capital assets[98] Employees and Remuneration Policy As of June 30, 2025, the Group had 173 employees in China, with total remuneration of approximately RMB 26.0 million, a decrease from the prior year; the company maintains an evaluation system for salary increases, bonuses, and promotions, provides training programs, and contributes to social insurance and housing provident funds for employees - As of June 30, 2025, the Group had 173 employees in China[99] Employee Headcount by Function | Function | Number of Employees | | :--- | :--- | | General Management and Administration | 18 | | Research and Development | 13 | | Senior Management | 5 | | Production, Purification, Equipment, Safety and Supply Chain | 78 | | Quality | 43 | | Clinical Support and Business Development | 16 | | Total | 173 | - For the six months ended June 30, 2025, the Group's total employee remuneration was approximately RMB 26.0 million, a decrease from approximately RMB 36.6 million in the corresponding period of 2024[99] Financing and Treasury Policy The Group adopts a sound and conservative financing and treasury policy aimed at maintaining optimal financial health, minimizing financial costs, and mitigating risks, with cash and cash equivalents held in financial institutions with low credit risk, and financing needs regularly reviewed to support operations, R&D, and future expansion - The Group adopts a stable and conservative financing and treasury policy, aiming to maintain an optimal financial position, the most economical finance costs, and the lowest financial risks[103] - Cash and cash equivalents are typically held in financial institutions that the Group considers to have low credit risk[103] - The Group regularly reviews its financing needs to maintain sufficient financial resources to support its business operations and R&D, future investments, and expansion plans[103] Share Option Schemes The Company has both a Pre-IPO Share Option Scheme and a Post-IPO Share Option Scheme to reward and incentivize participants; as of June 30, 2025, 35,930,000 share options remained unexercised under the Pre-IPO scheme, representing approximately 6.98% of total issued shares, while no options have been granted under the Post-IPO scheme since its adoption - The Company adopted the Pre-IPO Share Option Scheme on December 31, 2019, and the Post-IPO Share Option Scheme on June 6, 2020[104] - As of June 30, 2025, 35,930,000 share options remained unexercised under the Pre-IPO Share Option Scheme, representing approximately 6.98% of the total issued shares[105][109] - No share options have been granted, exercised, cancelled, or lapsed under the Post-IPO Share Option Scheme from the listing date up to the date of this announcement[110] Pre-IPO Share Option Scheme As of June 30, 2025, 35,930,000 share options remained unexercised under the Pre-IPO Share Option Scheme, primarily granted to Mr Tan Zheng (Chairman and Executive Director), Ms Wang Yu (resigned Executive Director), and other employees, with an exercise price of HKD 5.5 per share Unexercised Share Options under Pre-IPO Scheme | Name of Grantee | Number of Unexercised Share Options as at June 30, 2025 | | :--- | :--- | | Tan Zheng (Chairman and Executive Director) | 5,000,000 | | Wang Yu (Executive Director, CEO and CTO, resigned) | 23,450,000 | | Employees (Total) | 7,480,000 | | Total | 35,930,000 | - All unexercised share options were granted on December 31, 2019, with an exercise period from December 31, 2019, to December 30, 2026, and an exercise price of HKD 5.5 per share[107] Post-IPO Share Option Scheme The Post-IPO Share Option Scheme became effective from its adoption date for a maximum period of 10 years, and as of the date of this announcement, no share options have been granted, exercised, cancelled, or lapsed under this scheme - The Post-IPO Share Option Scheme became effective from its adoption date for a maximum period of 10 years[110] - No share options have been granted, exercised, cancelled, or lapsed under the Post-IPO Share Option Scheme from the listing date up to the date of this announcement[110] Compliance with Corporate Governance Code The Group is committed to maintaining high standards of corporate governance and has adopted the Corporate Governance Code set out in Appendix C1 of the Listing Rules; the Board believes the Company has complied with all applicable code provisions throughout the six months ended June 30, 2025 - The Group is committed to maintaining a high level of corporate governance and has adopted the Corporate Governance Code set out in Appendix C1 of the Listing Rules[112] - The Board believes that the Company has complied with all applicable code provisions of the Corporate Governance Code throughout the six months ended June 30, 2025[112] Compliance with Model Code for Securities Transactions The Company has adopted the Model Code set out in Appendix C3 of the Listing Rules to regulate securities transactions by directors and relevant employees; all directors confirmed compliance with the Model Code during the reporting period, and the company is unaware of any breaches by relevant employees - The Company has adopted the Model Code set out in Appendix C3 of the Listing Rules to regulate all transactions in the Company's securities by directors and relevant employees[113] - All directors have confirmed their compliance with the applicable standards set out in the Model Code for the six months ended June 30, 2025[113] Directors' Interests in Contracts During the reporting period and up to the date of this announcement, no director held any direct or indirect material interest in any contract entered into by the Company, its subsidiaries, or fellow subsidiaries that was significant to the Group's business - During the reporting period and up to the date of this announcement, no director held any direct or indirect material interest in any contract entered into by the Company, its subsidiaries, or fellow subsidiaries that was significant to the Group's business[114] Purchase, Sale and Redemption of Listed Securities As of June 30, 2025, the Company held no treasury shares, and neither the Company nor any of its subsidiaries purchased, sold, or redeemed any of the Company's shares during the reporting period - As of June 30, 2025, the Company held no treasury shares[115] - For the six months ended June 30, 2025, neither the Company nor any of its subsidiaries purchased, sold, or redeemed any of the Company's shares[115] Audit Committee and Review of Financial Report The Company's Audit Committee reviewed the unaudited consolidated interim results for the six months ended June 30, 2025, confirming compliance with applicable accounting principles and adequate disclosure; the interim results were reviewed by the auditor in accordance with Hong Kong Standard on Review Engagements 2410 - The Audit Committee comprises three members, including two independent non-executive directors (Mr Wu Zhijie as Chairman) and one non-executive director[116] - The Audit Committee reviewed the Company's unaudited consolidated interim results for the six months ended June 30, 2025, and confirmed compliance with applicable accounting principles, standards, and requirements, as well as adequate disclosure[117] - The interim results for the six months ended June 30, 2025, are unaudited but have been reviewed by the auditor in accordance with Hong Kong Standard on Review Engagements 2410[117] Review Report on Condensed Consolidated Financial Statements The independent auditor issued a disclaimer of conclusion on the Group's condensed consolidated financial statements for the six months ended June 30, 2025, primarily due to significant going concern uncertainties and the auditor's inability to obtain sufficient appropriate evidence to evaluate management's material assumptions in cash flow forecasts and the success probability of the company's liquidity improvement plans - The independent auditor issued a disclaimer of conclusion on the condensed consolidated financial statements[123] - The basis for the disclaimer of conclusion is the significant uncertainty regarding the Group's ability to continue as a going concern, including losses for the period, net cash outflows from operating activities, net current liabilities, and net liabilities[118] - The auditor was unable to obtain sufficient appropriate evidence to evaluate the relevant material assumptions and estimates in management's cash flow forecasts, as well as the probability of success of the Group's plans and measures (such as equity financing, bond extension, shareholder support, etc)[119][120] Changes in Directors During the reporting period, the Company's Board of Directors underwent several changes, including the appointments of Ms Yu Xiaohui, Mr Yang Xin, and Mr Liu Rui as non-executive directors, and Mr Zhang Guoguang as an independent non-executive director; concurrently, Mr Tao Ran resigned as a non-executive director, and Dr Wang Yu resigned as an executive director, CEO, and CTO - Ms Yu Xiaohui was appointed as a non-executive director and a member of the Audit Committee, effective April 25, 2025[124] - Dr Wang Yu resigned as an executive director and the Group's Chief Executive Officer and Chief Technology Officer, effective June 25, 2025[124] - Mr Yang Xin and Mr Liu Rui were appointed as non-executive directors, and Mr Zhang Guoguang was appointed as an independent non-executive director, all effective June 26, 2025[124] Changes in Directors' Information Except for the disclosed changes in directors, no changes in directors' biographical details requiring disclosure under Rule 13.51B(1) of the Listing Rules occurred from the publication date of the Group's 2024 annual report up to August 20, 2025 - Except as disclosed, no changes in directors' biographical details requiring disclosure under Rule 13.51B(1) of the Listing Rules occurred from the publication date of the Group's 2024 annual report up to August 20, 2025[126] Directors' Rights to Acquire Shares or Debentures Excluding the share option schemes, neither the Company nor its subsidiaries entered into any arrangements during or at the end of the reporting period that would enable directors to benefit from acquiring shares or debentures of the Company or any other body corporate, and no director, their spouse, or children under 18 were granted or exercised any rights to subscribe for equity or debt securities of the Company or any other body corporate - Except for the Pre-IPO Share Option Scheme and the Post-IPO Share Option Scheme, neither the Company nor its subsidiaries entered into any arrangements during or at the end of the reporting period that would enable directors to benefit from acquiring shares or debentures of the Company or any other body corporate[127] - No director, their spouse, or children under 18 years old were granted any rights to subscribe for equity or debt securities of the Company or any other body corporate, nor had they exercised any such rights[127] Publication of Interim Results and 2025 Interim Report This interim results announcement has been published on the Stock Exchange and the Company's websites, and the Company's interim report for the six months ended June 30, 2025, will be made available to shareholders and published in due course; the company encourages shareholders to view company communications online for environmental support - This interim results announcement is published on the Stock Exchange website (www.hkexnews.hk) and the Company's website (www.eaal.net)[128](index=128&type=chunk) - The Company's interim report for the six months ended June 30, 2025, will be made available to shareholders and published on the Stock Exchange and the Company's websites, respectively, in due course[128] - The Company encourages shareholders to view the Company's corporate communications via the Stock Exchange and the Company's websites instead of receiving printed copies[129] Events After Reporting Period Except as disclosed, to the best of the Company's knowledge, no significant events affecting the Group have occurred after the end of the reporting period up to the date of this announcement - Except as disclosed, to the best of the Company's knowledge, no significant events affecting the Group have occurred after the end of the reporting period up to the date of this announcement[130] Definitions and Glossary of Technical Terms Glossary This section defines key terms and technical vocabulary used in the report, covering product codes (e.g., 6B11, EAL®), company entities (e.g., Beijing Yongtai, Yongtai Ruike), therapeutic technologies (e.g., CAR-T cells, TCR-T cells), regulatory bodies (e.g., CDE), and financial and legal terms, to aid reader comprehension - Provides key product codes used in the report, such as "6B11" referring to ovarian cancer-related antibodies, and "EAL®" referring to the core multi-target cell immunotherapy pipeline product[5][131][132] - Explains cell immunotherapy-related technical terms, such as "CAR-T cell" referring to Chimeric Antigen Receptor T-cell, and "TCR" referring to T-cell receptor[131][132][135][136] - Defines regulatory and financial terms, such as "CDE" referring to the Center for Drug Evaluation of the NMPA, "GMP" referring to Good Manufacturing Practice, and "Convertible Bonds" referring to the secured convertible bonds issued by the Company[131][133][136]