宜明昂科(01541) - 2025 - 中期财报

Company Information Board of Directors and Committees This section lists the company's executive, non-executive, and independent non-executive directors, along with the composition of the Audit, Remuneration, and Nomination Committees - The Board of Directors includes Executive Directors Dr. Tian Wenzhi (Chairman, CEO, and CSO), Mr. Li Song, Ms. Guan Mei, Mr. Zhang Ruliang; Non-Executive Directors Dr. Xu Cong, Ms. Fu Dawei; and Independent Non-Executive Directors Dr. Zhu Zhenping, Dr. Kendall Arthur Smith, Mr. Yang Zhida[3] - Mr. Yang Zhida chairs the Audit Committee, Dr. Zhu Zhenping chairs the Remuneration Committee, and Dr. Tian Wenzhi chairs the Nomination Committee[3] Supervisory Board and Company Secretary This section provides the list of Supervisory Board members, including Chairperson Ms. Tian Miao, and information on Joint Company Secretaries and Authorized Representatives - The Supervisory Board is chaired by Ms. Tian Miao, with members including Mr. Zhao Zimeng and Ms. Zhang Wei[3] - The Joint Company Secretaries are Ms. Guan Mei and Mr. Li Jianwei, and the Authorized Representatives are Dr. Tian Wenzhi and Mr. Li Jianwei[3] Contact and Listing Information This section lists the company's principal bankers, registered office, headquarters, Hong Kong principal place of business, auditor, stock code, website, and listing date - The company's principal bankers include Industrial and Commercial Bank of China and China Merchants Bank[4] - The company's registered office, headquarters, and principal place of business in China are located in Pudong New Area, Shanghai, China; its principal place of business in Hong Kong is in Causeway Bay, Hong Kong[4][6] - The auditor is Deloitte Touche Tohmatsu, the stock code is 1541, and the listing date was September 5, 2023[6] Business Highlights Oncology Product Progress Significant progress in oncology pipeline, with core product IMM01 showing encouraging efficacy and good tolerability in Phase II trials for MDS, CMML, and cHL, and approved for Phase III - IMM01 achieved positive results in Phase II clinical trials for MDS, CMML, and cHL, and has been approved for Phase III clinical trials[9] - IMM2510 monotherapy for advanced squamous NSCLC achieved an ORR of 35.3% and a median PFS of 9.4 months[14] - IMM0306 combined with lenalidomide for R/R FL and MZL achieved ORR and CRR of 88.2% and 52.9% respectively[14] Core Product Progress - IMM01 IMM01 (Tidapaxicab) met primary endpoints in Phase II trials for higher-risk MDS and CMML, showing high ORR and CR rates with good tolerability, and is approved for Phase III trials - IMM01 combined with Azacitidine for higher-risk MDS in Phase II clinical trial showed an ORR of 64.7% and a CR rate of 33.3%[9] - IMM01 combined with Azacitidine for CMML in Phase II clinical trial achieved an ORR of 72.7% and a CR rate of 27.3%[9] - IMM01 combined with Tislelizumab for R/R cHL in Phase II clinical trial showed an ORR of 69.7%, a CR rate of 24.2%, a median DoR of 21.2 months, and a median PFS of 14.7 months[9] Progress of Other Selected Products IMM2510 monotherapy for advanced squamous NSCLC showed an ORR of 35.3% and median PFS of 9.4 months, while IMM0306 combined with lenalidomide for R/R FL and MZL in Phase IIa achieved ORR and CRR of 88.2% and 52.9% respectively - IMM2510 monotherapy for advanced squamous NSCLC achieved an ORR of 35.3%, DCR of 76.5%, and median PFS of 9.4 months[14] - IMM2510 combined with chemotherapy for first-line NSCLC in Phase II study showed an ORR of 61.9% in evaluable patients, with 80.0% in squamous NSCLC patients[14] - IMM0306 combined with lenalidomide for R/R FL and MZL in Phase IIa clinical trial achieved an ORR of 88.2% and a CRR of 52.9%[14] Non-Oncology Product Progress The company made progress in non-oncology areas, with IMM0306 showing good tolerability and efficacy in SLE Phase Ib trials and receiving IND approval for LN Phase II - IMM0306 for SLE in Phase Ib trial showed 85.7% and 87.5% of patients in 0.8 mg/kg and 1.2 mg/kg groups, respectively, achieved a ≥4-point reduction in SLEDAI-2000 score[18] - IMM0306 for NMOSD in Phase Ib trial completed patient enrollment for all three dose groups[18] - IMM0306 received IND approval for Lupus Nephritis (LN) Phase II trial[18] Business Development The company received a total of $15 million in payments from Axion Bio, bringing the total payments under the license and collaboration agreement to $30 million - Received a second near-term payment of $5 million and a milestone payment of $10 million from Axion Bio, Inc[17] - Total payments received under the license and collaboration agreement with Axion Bio reached $30 million[17] Financial Highlights Revenue and R&D Expenses Overview For the six months ended June 30, 2025, revenue significantly increased to RMB 38.0 million, primarily due to collaboration payments, while R&D expenses rose by 41.0% to RMB 168.0 million - Revenue: RMB 38.0 million for the six months ended June 30, 2025, an increase of RMB 37.9 million compared to RMB 0.1 million in the same period of 2024[20] - R&D expenses: RMB 168.0 million for the six months ended June 30, 2025, an increase of 41.0% compared to RMB 119.1 million in the same period of 2024[20] - Increase in R&D expenses primarily attributed to an increase of RMB 43.4 million in preclinical and CMC expenses, RMB 8.3 million in clinical trial expenses, and RMB 4.9 million in salaries and related benefits[20] Management Discussion and Analysis Overview The company, established in 2015, is a research-driven biotechnology company focused on developing innovative immuno-oncology therapies, leveraging its R&D platform and "Drug-by-Design" philosophy - Company established in 2015, focusing on developing innovative immuno-oncology therapies[21] - Possesses a pipeline of over ten innovative drug candidates and 12 ongoing clinical programs[21] Business Review Significant progress was made in developing core product IMM01 and other oncology and non-oncology pipeline products, with IMM01 advancing to Phase III after strong Phase II results - IMM01 achieved positive results in Phase II clinical trials for MDS, CMML, and cHL, and has been approved for Phase III clinical trials[24][27][36] - IMM2510 monotherapy for advanced squamous NSCLC achieved an ORR of 35.3% and a median PFS of 9.4 months[43] - IMM0306 combined with lenalidomide for R/R FL and MZL in Phase IIa clinical trial achieved an ORR of 88.2% and a CRR of 52.9%[46] Candidate Product - IMM01 (Tidapaxicab) (SIRPα-Fc Fusion Protein) IMM01, a core product, met primary endpoints in Phase II trials for higher-risk MDS and CMML, showing high ORR and CR rates, and is approved for Phase III trials - IMM01 combined with Azacitidine for higher-risk MDS in Phase II clinical trial showed an ORR of 64.7% and a CR rate of 33.3%, with ORR reaching 89.7% and CR rate 58.6% in patients treated for ≥6 months[24] - IMM01 combined with Tislelizumab for R/R cHL in Phase II clinical trial showed an ORR of 69.7%, a CR rate of 24.2%, a median DoR of 21.2 months, a median PFS of 14.7 months, and an 18-month OS rate of 91.6%[36] - IND preparation for IMM01 in the treatment of atherosclerosis is underway[40] Candidate Product - IMM2510 (Pervilafusp α) (VEGF×PD-L1) IMM2510, a bispecific molecule targeting VEGF and PD-L1, showed an ORR of 35.3% and a median PFS of 9.4 months in advanced squamous NSCLC monotherapy - IMM2510 monotherapy for advanced squamous NSCLC achieved an ORR of 35.3%, DCR of 76.5%, and median PFS of 9.4 months[43] - In the Phase II study of IMM2510 combined with chemotherapy for first-line NSCLC, the ORR for 21 evaluable efficacy patients was 61.9%, with 80.0% for squamous NSCLC patients[43] - The safety run-in phase for the TNBC cohort in the IMM2510-003 study started on June 10, 2025, with 2 confirmed PRs and 1 SD observed[43] Candidate Product - IMM27M (Taizesubaimab) (CTLA-4 ADCC-Enhanced Monoclonal Antibody) IMM27M, a next-generation CTLA-4 antibody with enhanced ADCC activity, completed Phase I dose-escalation with good tolerability and two confirmed PRs - IMM27M is a next-generation CTLA-4 antibody with enhanced ADCC activity[43] - Phase I dose-escalation study completed patient enrollment, showing safety and good tolerability, no dose-limiting toxicities, and RP2D determined[46] - Two confirmed PRs were observed in the Phase I dose-escalation study[46] Candidate Product - IMM0306 (Amurevup α) (CD47×CD20) IMM0306, the world's first clinical-stage CD47 and CD20 bispecific molecule, showed strong anti-tumor activity and good tolerability in R/R FL and MZL trials - IMM0306 is the world's first clinical-stage CD47 and CD20 bispecific molecule[46] - IMM0306 combined with lenalidomide for R/R FL and MZL in Phase Ib trial showed good tolerability and strong preliminary anti-tumor activity[46] - In the Phase IIa dose-expansion clinical trial, the ORR for 34 evaluable efficacy patients was 88.2%, and the CRR was 52.9%[46] Candidate Product - IMM2520 (CD47×PD-L1) IMM2520, a CD47 and PD-L1 bispecific molecule for solid tumors, has a unique structure that avoids red blood cell binding and activates macrophages, with its Phase I study ongoing - IMM2520 is a CD47 and PD-L1 bispecific molecule for treating solid tumors[55] - Its unique structure avoids binding to red blood cells and fully activates macrophages[55] - Phase I study started in March 2023, with 26 patients enrolled as of July 2, 2025[55] Candidate Products - Non-Oncology Therapeutic Areas The company expanded R&D into non-oncology, with IMM0306 showing good tolerability and efficacy in SLE Phase Ib trials and receiving IND approval for LN Phase II - IMM0306 for SLE in Phase Ib trial showed 85.7%-87.5% of patients achieved a ≥4-point reduction in SLEDAI-2000 score[55] - IMM0306 received IND approval for Lupus Nephritis (LN) Phase II trial[55] - IMM72/IMC-003 received IND approval in June 2025 and initiated healthy volunteer recruitment in August[54] Business Development The company received a total of $15 million in payments from Axion Bio, bringing the total payments under the license and collaboration agreement to $30 million - Received a second near-term payment of $5 million and a milestone payment of $10 million from Axion Bio[57] - Total payments received under the license and collaboration agreement with Axion Bio reached $30 million[57] Future and Outlook For the second half of 2025, the company plans to continue advancing candidate drug development, expanding clinical applications, and exploring overseas markets - Company plans to continue advancing candidate drug development and expanding clinical applications in the second half of 2025[58] - Plans to expand into overseas markets and leverage Chinese clinical data to accelerate global clinical progress[58] - Will continue to screen and evaluate other innate immune checkpoints to enrich its pipeline[58] Financial Review For the six months ended June 30, 2025, revenue significantly increased to RMB 38.0 million, R&D expenses rose by 41.0%, and loss for the period narrowed to RMB 152.7 million - Loss for the period: RMB 152.7 million for the six months ended June 30, 2025, a decrease from RMB 165.8 million in the same period of 2024[72] - Adjusted net loss: RMB 144.4 million for the six months ended June 30, 2025, compared to RMB 120.7 million in the same period of 2024[74] Revenue For the six months ended June 30, 2025, the company's revenue was RMB 38.0 million, a significant increase from RMB 0.1 million in the same period of 2024, primarily due to collaboration payments Revenue Composition | Indicator | For the six months ended June 30, 2025 (RMB in thousands) | For the six months ended June 30, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Revenue from collaboration development | 37,995 | — | | Sales of cell lines and other products | 32 | 49 | | Revenue from testing services | — | 28 | | Total | 38,027 | 77 | Other Income For the six months ended June 30, 2025, other income increased to RMB 9.7 million, up from RMB 4.3 million in the same period of 2024, mainly due to an increase in government grants Other Income Composition | Indicator | For the six months ended June 30, 2025 (RMB in thousands) | For the six months ended June 30, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Government grants | 5,987 | 642 | | Bank interest income | 3,706 | 3,635 | | Total | 9,693 | 4,277 | Net Other Gains and Losses For the six months ended June 30, 2025, net other gains and losses shifted from a loss of RMB 19.5 million in 2024 to a loss of RMB 2.7 million, primarily due to reduced impairment loss on property and equipment Net Other Gains and Losses | Indicator | For the six months ended June 30, 2025 (RMB in thousands) | For the six months ended June 30, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Net exchange (losses) / gains | (2,354) | 1,378 | | (Losses) / gains from fair value changes of financial assets measured at fair value | (340) | 6,540 | | Impairment loss on property and equipment | — | (27,398) | | Others | (5) | (7) | | Total | (2,699) | (19,487) | Research and Development Expenses For the six months ended June 30, 2025, R&D expenses increased by 41.0% year-on-year to RMB 168.0 million, mainly due to increased preclinical, CMC, and clinical trial expenses R&D Expenses Composition | Indicator | For the six months ended June 30, 2025 (RMB in thousands) | For the six months ended June 30, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Preclinical and CMC expenses | 60,858 | 17,495 | | Clinical trial expenses | 49,831 | 41,499 | | Salaries and related benefits | 38,135 | 33,272 | | Cost of materials and consumables | 7,563 | 7,810 | | Share-based payments | 2,450 | 9,182 | | Depreciation expenses | 6,051 | 6,877 | | Others | 3,156 | 3,003 | | Total | 168,044 | 119,138 | Administrative Expenses For the six months ended June 30, 2025, administrative expenses decreased by 9.3% year-on-year to RMB 27.3 million, primarily due to a reduction in non-cash share-based payments - Administrative expenses: RMB 27.3 million for the six months ended June 30, 2025, a 9.3% decrease from RMB 30.1 million in the same period of 2024[67] - Decrease primarily attributed to a reduction in non-cash share-based payments[67] Finance Costs For the six months ended June 30, 2025, finance costs increased to RMB 2.4 million, up from RMB 1.4 million in the same period of 2024, mainly due to increased interest on borrowings - Finance costs: RMB 2.4 million for the six months ended June 30, 2025, an increase from RMB 1.4 million in the same period of 2024[70] - Increase primarily due to increased interest on borrowings[70] Income Tax Expense For the six months ended June 30, 2024 and 2025, the company incurred no income tax expense as neither the company nor its subsidiaries had taxable profits - No income tax expense incurred for the six months ended June 30, 2024 and 2025[71] Loss for the Period For the six months ended June 30, 2025, the company's loss for the period was RMB 152.7 million, a decrease from RMB 165.8 million in the same period of 2024 - Loss for the period: RMB 152.7 million for the six months ended June 30, 2025, a decrease from RMB 165.8 million in the same period of 2024[72] Non-IFRS Measures The company uses adjusted net loss as a non-IFRS measure to assess operating performance, which was RMB 144.4 million for the six months ended June 30, 2025 Reconciliation of Loss to Adjusted Loss | Indicator | For the six months ended June 30, 2025 (RMB in thousands) | For the six months ended June 30, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Loss for the period | (152,725) | (165,760) | | Add: Share-based payment expenses | 8,302 | 17,701 | | Add: Impairment loss on property and equipment | — | 27,398 | | Adjusted loss for the period | (144,423) | (120,661) | Material Acquisitions and Disposals The company disposed of 100% equity in Shanghai Zhangtou Yaoxin Technology Development Co., Ltd. for a maximum consideration of RMB 98.19 million, with the equity transfer completed on February 21, 2025 - Company disposed of 100% equity in Shanghai Zhangtou Yaoxin Technology Development Co., Ltd. for a maximum consideration of RMB 98,188,983.55[75] - Equity transfer completed on February 21, 2025, with the company receiving the first two installments totaling RMB 66,178,983.55[75] Capital Structure, Liquidity, and Financial Resources As of June 30, 2025, cash and cash equivalents and financial assets measured at fair value totaled RMB 703.7 million, a decrease from December 31, 2024, primarily due to cash outflows from operations and R&D - Total cash and cash equivalents and financial assets measured at fair value: RMB 703.7 million as of June 30, 2025, compared to RMB 752.1 million as of December 31, 2024[77] - Net cash used in operating activities: RMB 131.1 million for the period ended June 30, 2025, an increase of RMB 8.1 million from the same period of 2024[77] - Company has unutilized bank loan facilities of approximately RMB 90 million[79] Gearing Ratio As of June 30, 2025, the company's gearing ratio was 30.8%, an increase of 4.4% from December 31, 2024, primarily due to a decrease in total assets - Gearing ratio: 30.8% as of June 30, 2025, an increase of 4.4% from 26.4% as of December 31, 2024[80] - Increase primarily due to a decrease of RMB 80.2 million in assets classified as held for sale and RMB 72.2 million in cash and cash equivalents, respectively[80] Indebtedness As of June 30, 2025, the company had unsecured bank borrowings of RMB 137.0 million, primarily denominated in RMB, with interest rates ranging from 2.8% to 3.6% - Unsecured bank borrowings: RMB 137.0 million as of June 30, 2025, an increase from RMB 115.4 million as of December 31, 2024[81] - All bank borrowings bear fixed interest rates ranging from 2.8% to 3.6% per annum[81] - Lease liabilities: Decreased from RMB 21.0 million to RMB 16.7 million[82] Capital Commitments As of June 30, 2025, the company had contracted but unprovided capital commitments of RMB 0.4 million, primarily for the purchase of property and equipment - Contracted but unprovided capital commitments: RMB 0.4 million as of June 30, 2025[83] Contingent Liabilities As of June 30, 2025, the company had no contingent liabilities - No contingent liabilities as of June 30, 2025[84] Charges on Assets As of June 30, 2025, the company had no charged assets - No charged assets as of June 30, 2025[85] Foreign Exchange Risk The company faces foreign exchange risk as some financial assets and liabilities are denominated in foreign currencies, with management monitoring the risk without a current hedging policy - Company faces foreign exchange risk due to some financial assets and liabilities denominated in foreign currencies[86] - Currently has no foreign currency hedging policy, but management monitors the risk[86] Material Investments Held As of June 30, 2025, the company held three redeemable structured note wealth management products with a total fair value of RMB 275.389 million, denominated in HKD, which recorded fair value losses due to HKD depreciation - As of June 30, 2025, company held three redeemable structured note wealth management products with fair values of RMB 47.855 million, RMB 40.488 million, and RMB 187.046 million respectively[87] - Wealth management products denominated in HKD recorded fair value change losses during the reporting period, primarily due to the depreciation of HKD against RMB[87] Future Plans for Material Investments or Capital Assets As of June 30, 2025, the company had no detailed future plans regarding material investments or capital assets - No detailed future plans regarding material investments or capital assets as of June 30, 2025[89] Employees and Remuneration Policy As of June 30, 2025, the company had 195 employees, with total remuneration costs decreasing to RMB 58.6 million due to reduced non-cash share-based payments - Company had 195 employees as of June 30, 2025[90] - Total remuneration costs: RMB 58.6 million for the six months ended June 30, 2025, a decrease from RMB 60.8 million in the same period of 2024[90] - Decrease in total remuneration primarily due to a reduction in non-cash share-based payments[90] Corporate Governance and Other Information Disclosure of Interests This section discloses the interests and short positions of directors, supervisors, chief executives, and substantial shareholders in the company's shares and its associated corporations as of June 30, 2025 - Dr. Tian (Chairman, CEO, CSO, and Executive Director) directly and indirectly held approximately 38.49% of the company's total share capital[92][93][94][96] - Mr. Yu Xiaoyong held approximately 8.95% of the company's shares through controlled corporate interests[96][101] - Zhangke Lingyi Shengfan beneficially owned approximately 4.88% of the company's H shares[96] Employee Shareholding Platforms The company established domestic and overseas employee shareholding platforms to incentivize employees, with 30,356,955 shares granted to 29 eligible grantees prior to listing - Company established domestic employee shareholding platforms (Jiaxing Changxian, Jiaxing Changyu) and an overseas employee shareholding platform (Halo Investment II)[100] - Prior to listing, a total of 30,356,955 shares were granted to 29 eligible grantees[107] - No new shares will be granted under the employee incentive plan after listing[107] Use of Proceeds The company disclosed the use of proceeds from the global offering and placing, with funds primarily allocated to clinical trials, R&D, and working capital - Net proceeds from global offering: approximately HKD 251.3 million, with HKD 206.4 million utilized as of June 30, 2025, and HKD 44.9 million remaining for use by end of 2026[122] - Net proceeds from placing: approximately HKD 229.7 million, with HKD 48.1 million utilized as of June 30, 2025, and HKD 179.8 million remaining for use by mid-2027[126] Future Plans for Material Investments and Capital Assets As of June 30, 2025, the company had no existing plans for acquiring other material investments or capital assets - No existing plans for acquiring other material investments or capital assets as of June 30, 2025[127] Changes in Information of Directors, Supervisors, and Senior Management During the reporting period, the company made several appointments to senior management and the Board, including a Chief Business Officer, Chief Medical Officer, and new Executive and Non-Executive Directors - Dr. Weihai He appointed Chief Business Officer, effective May 5, 2025[128] - Dr. Zhuli Wu appointed Chief Medical Officer, effective June 9, 2025[129] - Mr. Zhang Ruliang appointed Executive Director and Ms. Fu Dawei appointed Non-Executive Director of the second Board of Directors, both effective May 28, 2025[130][131] Other Corporate Changes The company completed the full circulation of H shares, converting 14,114,006 unlisted shares into H shares, which were listed and traded on the Stock Exchange on May 15, 2025 - Company completed full circulation of H shares, converting 14,114,006 unlisted shares into H shares[133] - Converted H shares commenced trading on the Stock Exchange at 9:00 a.m. on May 15, 2025[133] Material Events After Reporting Period As of the date of this interim report, there were no other material events after the end of the reporting period, except as disclosed herein - No other material events after the end of the reporting period as of the date of this interim report[134] Compliance with Corporate Governance Code The company complied with most applicable code provisions of the Corporate Governance Code, with a deviation regarding the Chairman and CEO roles, which the Board believes ensures consistent leadership - Company complied with all applicable code provisions of the Corporate Governance Code during the reporting period, except for deviation from code provision C.2.1 (separation of Chairman and CEO roles)[135] - Board believes Dr. Tian's dual role ensures consistent leadership and efficient decision-making for the Group[135] - Appointments to the Nomination Committee aim to enhance the efficiency and diversity of the Board and Nomination Committee, improving corporate governance[136] Compliance with Standard Securities Dealing Code The company adopted a code of conduct for securities transactions no less exacting than the Model Code, and all directors and supervisors confirmed compliance during the reporting period - Company adopted a code of conduct for securities transactions no less exacting than the Model Code in Appendix C3 of the Listing Rules[139] - All directors and supervisors confirmed compliance with the code during the reporting period[139] Review of Interim Results The Audit Committee reviewed the unaudited interim financial results for the six months ended June 30, 2025, and deemed them compliant with applicable accounting standards, rules, and regulations - Audit Committee reviewed the unaudited interim financial results for the six months ended June 30, 2025[141] - Audit Committee deemed the results compliant with applicable accounting standards, rules, and regulations, and properly disclosed[141] Purchase, Sale, or Redemption of the Company's Listed Securities During the reporting period, neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities, and no treasury shares were held as of June 30, 2025 - Neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities during the reporting period[142] - Company held no treasury shares as of June 30, 2025[142] Continuing Disclosure Obligations under Listing Rules As of June 30, 2025, the directors were unaware of any circumstances requiring disclosure obligations under Listing Rules 13.20, 13.21, and 13.22 - Directors were unaware of any circumstances requiring disclosure obligations under Listing Rules 13.20, 13.21, and 13.22 as of June 30, 2025[143] Interim Dividend The Board of Directors resolved not to recommend the payment of an interim dividend for the six months ended June 30, 2025 - Board resolved not to recommend the payment of an interim dividend for the six months ended June 30, 2025[144] Independent Review Report Review Conclusion Deloitte Touche Tohmatsu reviewed the company's condensed consolidated financial statements for the six months ended June 30, 2025, and found no material issues regarding their preparation in accordance with IAS 34 - Deloitte Touche Tohmatsu reviewed the company's condensed consolidated financial statements[146] - Review conducted under Hong Kong Standard on Review Engagements 2410, with a scope less than an audit, thus no audit opinion expressed[147] - Conclusion: nothing came to attention suggesting financial statements are not prepared, in all material respects, in accordance with International Accounting Standard 34[148] Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income Profit or Loss and Comprehensive Income Overview For the six months ended June 30, 2025, the company recorded revenue of RMB 38,027 thousand and other income of RMB 9,693 thousand, with a narrowed loss for the period of RMB 152,725 thousand Summary of Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income | Indicator | For the six months ended June 30, 2025 (RMB in thousands) | For the six months ended June 30, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Revenue | 38,027 | 77 | | Other income | 9,693 | 4,277 | | Net other gains and losses | (2,699) | (19,487) | | Research and development expenses | (168,044) | (119,138) | | Administrative expenses | (27,257) | (30,063) | | Finance costs | (2,445) | (1,426) | | Loss for the period | (152,725) | (165,760) | | Loss per share (RMB) | (0.37) | (0.44) | Condensed Consolidated Statement of Financial Position Financial Position Overview As of June 30, 2025, the company's total assets less current liabilities were RMB 553,221 thousand, with net assets of RMB 533,881 thousand, and current assets including RMB 298,303 thousand in financial assets and RMB 405,395 thousand in cash Summary of Condensed Consolidated Statement of Financial Position | Indicator | As of June 30, 2025 (RMB in thousands) | As of December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Non-current assets | 45,500 | 54,058 | | Current assets | 725,744 | 867,938 | | Assets classified as held for sale | — | 80,196 | | Current liabilities | 218,023 | 214,642 | | Non-current liabilities | 19,340 | 29,049 | | Net assets | 533,881 | 678,305 | Condensed Consolidated Statement of Changes in Equity Equity Changes Overview For the six months ended June 30, 2025, total equity attributable to owners of the company decreased to RMB 534,615 thousand, primarily due to a loss for the period, partially offset by an increase in share-based payments Summary of Condensed Consolidated Statement of Changes in Equity | Indicator | As of June 30, 2025 (RMB in thousands) | As of January 1, 2025 (RMB in thousands) | | :--- | :--- | :--- | | Share capital | 407,308 | 407,308 | | Share premium | 1,092,578 | 1,092,578 | | Share-based payment reserve | 213,630 | 205,328 | | Translation reserve | (115) | (114) | | Accumulated losses | (1,178,786) | (1,026,200) | | Subtotal equity attributable to owners of the company | 534,615 | 678,900 | | Non-controlling interests | (734) | (595) | | Total equity | 533,881 | 678,305 | Condensed Consolidated Statement of Cash Flows Cash Flow Overview For the six months ended June 30, 2025, net cash used in operating activities was RMB 131,117 thousand, with net cash from investing activities of RMB 45,201 thousand and financing activities of RMB 16,064 thousand Summary of Condensed Consolidated Statement of Cash Flows | Indicator | For the six months ended June 30, 2025 (RMB in thousands) | For the six months ended June 30, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | (131,117) | (123,017) | | Net cash from investing activities | 45,201 | 40,266 | | Net cash from financing activities | 16,064 | 21,508 | | Net decrease in cash and cash equivalents | (69,852) | (61,243) | | Cash and cash equivalents at end of period | 405,395 | 246,848 | Notes to the Condensed Consolidated Financial Information General Information and Basis of Preparation Immuno Cure BioTech (Shanghai) Co., Ltd. was incorporated in China on June 18, 2015, and listed on the HKEX on September 5, 2023, with its principal business being R&D of immuno-oncology therapies - Company incorporated in China on June 18, 2015, and listed on HKEX on September 5, 2023[157] - Principal business is R&D of immuno-oncology therapies[158] - Condensed consolidated financial statements prepared in accordance with IAS 34 and Listing Rules, using the going concern basis[159] Principal Accounting Policies The condensed consolidated financial statements are prepared on a historical cost basis, with accounting policies consistent with the prior annual statements, and IFRS amendments had no material impact - Condensed consolidated financial statements prepared on a historical cost basis, with some financial instruments measured at fair value[160] - Accounting policies consistent with annual consolidated financial statements for the year ended December 31, 2024[160] - Application of IFRS amendments had no material impact on financial position and performance[161] Revenue and Segment Information For the six months ended June 30, 2025, the company's revenue was RMB 38,027 thousand, primarily from collaboration development with Axion Bio, and it operates in a single segment with all non-current assets in China Disaggregation of Revenue from Contracts with Customers | Type of goods or services | For the six months ended June 30, 2025 (RMB in thousands) | For the six months ended June 30, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Collaboration development | 37,995 | — | | Sales of cell lines and other products | 32 | 49 | | Testing services | — | 28 | | Total | 38,027 | 77 | - Collaboration development revenue primarily from license and collaboration agreement with Axion Bio, recognized over time[163][164] - Company has a single operating segment, with all non-current assets located in China[168][169] Other Income For the six months ended June 30, 2025, the company's other income was RMB 9,693 thousand, mainly comprising government grants and bank interest income Other Income Composition | Indicator | For the six months ended June 30, 2025 (RMB in thousands) | For the six months ended June 30, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Government grants | 5,987 | 642 | | Bank interest income | 3,706 | 3,635 | | Total | 9,693 | 4,277 | Net Other Gains and Losses For the six months ended June 30, 2025, the company's net other gains and losses resulted in a loss of RMB 2,699 thousand, primarily due to exchange loss and fair value change loss of financial assets Net Other Gains and Losses | Indicator | For the six months ended June 30, 2025 (RMB in thousands) | For the six months ended June 30, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Net exchange (losses) / gains | (2,354) | 1,378 | | (Losses) / gains from fair value changes of financial assets measured at fair value | (340) | 6,540 | | Impairment loss on property and equipment | — | (27,398) | | Others | (5) | (7) | | Total | (2,699) | (19,487) | Loss for the Period For the six months ended June 30, 2025, the company's loss for the period was RMB 152,725 thousand, with loss before tax deducted by total depreciation, directors' and supervisors' emoluments, and other staff costs Components of Loss for the Period | Indicator | For the six months ended June 30, 2025 (RMB in thousands) | For the six months ended June 30, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Depreciation of property and equipment | 4,254 | 5,777 | | Depreciation of right-of-use assets | 3,095 | 5,147 | | Total depreciation | 7,349 | 10,924 | | Directors' and supervisors' emoluments | 11,544 | 13,415 | | Total other staff costs | 47,093 | 47,431 | Income Tax Expense For the six months ended June 30, 2024 and 2025, no provision for income tax expense was made as neither the company nor its subsidiaries had taxable profits - No provision for income tax expense made for the six months ended June 30, 2024 and 2025[174] Loss Per Share For the six months ended June 30, 2025, basic and diluted loss per share attributable to owners of the company was RMB 0.37, a narrowing from RMB 0.44 in the same period of 2024 Loss Per Share Calculation | Indicator | For the six months ended June 30, 2025 | For the six months ended June 30, 2024 | | :--- | :--- | :--- | | Loss for the purpose of calculating basic loss per share (RMB in thousands) | (152,586) | (165,760) | | Weighted average number of ordinary shares for the purpose of calculating basic loss per share (in thousands) | 407,308 | 374,158 | | Basic and diluted loss per share (RMB) | (0.37) | (0.44) | Dividends During the interim period, no dividends were paid, declared, or proposed by the company, and the Board resolved not to pay dividends for the interim period - No dividends paid, declared, or proposed by the company during the interim period[176] Property and Equipment and Right-of-Use Assets During this interim period, the company incurred approximately RMB 420,000 for the purchase of property and equipment, and no new lease agreements were entered into for the six months ended June 30, 2025 - Company incurred approximately RMB 420,000 for the purchase of property and equipment during this interim period[177] - No new lease agreements entered into for the six months ended June 30, 2025[178] Trade Receivables As of June 30, 2025, the company's trade receivables totaled RMB 10 thousand, a decrease from RMB 16 thousand as of December 31, 2024, with a typical credit period of 30 days Ageing Analysis of Trade Receivables | Ageing | As of June 30, 2025 (RMB in thousands) | As of December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Within 30 days | — | 6 | | 31 to 60 days | 4 | 7 | | 61 to 120 days | — | — | | 121 to 180 days | — | 3 | | Over 180 days | 6 | — | | Total | 10 | 16 | Prepayments and Other Receivables As of June 30, 2025, the company's prepayments and other receivables totaled RMB 22,036 thousand, a decrease from RMB 35,604 thousand as of December 31, 2024 Composition of Prepayments and Other Receivables | Indicator | As of June 30, 2025 (RMB in thousands) | As of December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Deposits for plant construction | — | 9,851 | | Receivables from disposal of a subsidiary | 14,017 | — | | Other receivables | 133 | 168 | | Prepayments for purchases of goods and R&D services | 7,883 | 24,543 | | Other prepayments | 3 | 1,042 | | Total | 22,036 | 35,604 | Financial Assets Measured at Fair Value Through Profit or Loss As of June 30, 2025, the company's financial assets measured at fair value were RMB 298,303 thousand, primarily wealth management products classified as Level 2 fair value hierarchy and valued using the income approach Financial Assets Measured at Fair Value | Indicator | As of June 30, 2025 (RMB in thousands) | As of December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Wealth management products | 298,303 | 274,521 | - Wealth management products are not guaranteed by related financial institutions, classified as Level 2 fair value hierarchy, and valued using the income approach[182][199] Cash and Cash Equivalents As of June 30, 2025, the company's bank balances were RMB 405,395 thousand, bearing interest at market rates ranging from 0.01% to 4.20% Cash and Cash Equivalents | Indicator | As of June 30, 2025 (RMB in thousands) | As of December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Bank balances | 405,395 | 477,601 | - Bank balances bear interest at market rates ranging from 0.01% to 4.20% per annum[183] - At period-end, bank balances denominated in USD were RMB 107,361 thousand, and in HKD were RMB 157,049 thousand[184] Assets Classified as Held for Sale In December 2024, the company agreed to dispose of its subsidiary, Shanghai Zhangtou Yaoxin Technology Development Co., Ltd., which primarily held land use rights and construction in progress, with the equity transfer completed in Q1 2025 - Company disposed of subsidiary Shanghai Zhangtou Yaoxin Technology Development Co., Ltd., which primarily held land use rights and construction in progress[185] - Company received the first two installments totaling RMB 66,179,000 and completed the equity transfer in the first quarter of 2025[185] Trade and Other Payables As of June 30, 2025, the company's trade and other payables totaled RMB 52,722 thousand, a decrease from December 31, 2024, including trade payables for R&D expenses and accrued outsourced R&D expenses Composition of Trade and Other Payables | Indicator | As of June 30, 2025 (RMB in thousands) | As of December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Trade payables for research and development expenses | 14,346 | 43,244 | | Accrued outsourced research and development expenses | 16,989 | 10,985 | | Accrued staff costs and benefits | 13,388 | 15,903 | | Accrued research and development materials and consumables | 5,282 | 1,149 | | Others | 2,717 | 3,150 | | Total | 52,722 | 74,431 | - Company's average credit period for purchases of goods/services is 45 days[186] Contract Liabilities As of June 30, 2025, the company's contract liabilities were RMB 30,920 thousand, primarily from collaboration development, and are presented as current liabilities Contract Liabilities | Indicator | As of June 30, 2025 (RMB in thousands) | As of December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Collaboration development | 30,920 | 32,900 | - Contract liabilities are presented as current liabilities in the condensed consolidated statement of financial position[187] Borrowings As of June 30, 2025, the company's total fixed-rate borrowings were RMB 136,990 thousand, with bank borrowing interest rates ranging from 2.80% to 3.60% per annum Composition of Borrowings | Indicator | As of June 30, 2025 (RMB in thousands) | As of December 31, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Fixed-rate borrowings measured at amortized cost | 136,990 | 115,390 | | Of which: repayable within one year | 127,990 | 100,890 | | Repayable within one year but not exceeding two years | 9,000 | 14,500 | - Bank borrowing interest rates range from 2.80% to 3.60% per annum[188] Share Capital As of June 30, 2025, the company's total authorized and issued ordinary shares were 407,307,695, with a share capital of RMB 407,308 thousand, following an H share issuance in November 2024 Share Capital Information | Indicator | As of June 30, 2025 (Number of shares) | As of June 30, 2025 (RMB in thousands) | | :--- | :--- | :--- | | Authorized and issued ordinary shares | 407,307,695 | 407,308 | - On November 28, 2024, company issued 33,150,000 H shares, raising gross proceeds of approximately HKD 233,708,000[189] Share-Based Payment Transactions The company implements restricted share schemes through employee shareholding platforms to incentivize eligible personnel, with 6,480 thousand unvested restricted shares as of June 30, 2025, and RMB 8,302 thousand in share-based payment expenses recognized Restricted Share Movements | Indicator | Unvested as of June 30, 2025 (in thousands) | Unvested as of December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Unvested restricted shares | 6,480 | 14,220 | | Weighted average grant date fair value (RMB) | 8.29 | 8.16 | - For the six months ended June 30, 2025, company recognized share-based payment expenses of RMB 8,302 thousand[194] Related Party Transactions This section discloses transactions with related parties, including restricted share payment expenses for Dr. Yumei Ding and total remuneration for key management personnel - Restricted share payment expenses for Dr. Yumei Ding (spouse of Dr. Tian Wenzhi) were RMB 250 thousand[195] Key Management Personnel Remuneration | Indicator | For the six months ended June 30, 2025 (RMB in thousands) | For the six months ended June 30, 2024 (RMB in thousands) | | :--- | :--- | :--- | | Salaries and other benefits | 6,876 | 6,428 | | Contributions to retirement benefit plans | 281 | 420 | | Discretionary bonuses | 1,125 | 1,139 | | Share-based payments | 6,771 | 18,699 | | Total | 15,053 | 26,686 | Fair Value Measurement of Financial Instruments The company's financial assets are measured at fair value at the end of the reporting period, primarily wealth management products classified as Level 2 fair value hierarchy and valued using the income approach Financial Assets Measured at Fair Value on a Recurring Basis | Indicator | As of June 30, 2025 (RMB in thousands) | As of December 31, 2024 (RMB in thousands) | Fair Value Level | Valuation Techniques and Key Inputs | | :--- | :--- | :--- | :--- | :--- | | Financial assets measured at fair value | 298,303 | 274,521 | Level 2 | Income approach — using discounted cash flow method to estimate the returns of the relevant assets | - Carrying amounts of financial assets and liabilities recognized at amortized cost approximate their fair values[201] Events After the Reporting Period On July 30, 2025, the company received a milestone payment of USD 10,000,000 from Instil under the license and collaboration agreement - On July 30, 2025, company received a milestone payment of USD 10,000,000 from Instil[202] Definitions and Glossary Definitions of Key Terms This section provides definitions for key terms and vocabulary used in the report, covering professional terminology in corporate governance, finance, product development, and regulation - Provides definitions for key terms and vocabulary used in the report[203] - Includes important definitions such as "Core Product," "Corporate Governance Code," and "NMPA"[203][204]