Clinical Trials and Efficacy - The overall response rate (ORR) for IMM01 in high-risk myelodysplastic syndromes (MDS) was 64.7%, with a complete response (CR) rate of 33.3% as of December 31, 2024[5]. - In the II phase trial for chronic myelomonocytic leukemia (CMML), the ORR was 72.7%, including a CR rate of 27.3%[5]. - For the II phase trial of IMM01 combined with pembrolizumab in relapsed/refractory classical Hodgkin lymphoma (cHL), the ORR was 69.7%, with a CR rate of 24.2%[6]. - A total of 33 patients were recruited for the IMM2510 I phase dose escalation study, showing promising anti-tumor activity with three confirmed partial responses (PR)[7]. - As of December 31, 2024, 74 patients were recruited for the Ib/II phase trial of IMM2510, indicating good safety and preliminary efficacy[7]. - The company initiated the IMM27M I phase dose escalation study, with initial data showing safety and good tolerability in heavily pre-treated advanced solid tumor patients[8]. - In the Ib phase trial of IMM0306 combined with lenalidomide for relapsed/refractory follicular lymphoma (FL), the overall response rate (ORR) was 90.9%[8]. - The Phase II clinical trial of IMM01 combined with Azacitidine for high-risk myelodysplastic syndromes (MDS) has recruited 57 patients, achieving an overall response rate (ORR) of 64.7%[23]. - In patients treated for at least 6 months, the ORR increased to 89.7%, indicating enhanced efficacy with prolonged treatment duration[23]. - The Phase II trial for IMM01 combined with Azacitidine in chronic myelomonocytic leukemia (CMML) has recruited 24 patients, with an ORR of 72.7%[25]. - The company has observed promising anti-tumor activity and manageable safety in the ongoing clinical trials for various cancer treatments[45]. Financial Performance - As of December 31, 2024, the company reported revenue of RMB 741 million, a significant increase of RMB 737 million compared to RMB 4 million for the year ended December 31, 2023, primarily due to upfront and recent payments received from the collaboration agreement with Axion Bio, Inc.[14]. - The company recorded total revenue of RMB 74.1 million for the year ended December 31, 2024, compared to RMB 0.4 million for the year ended December 31, 2023, primarily from licensing fees and collaboration development[58]. - The company reported a pre-tax loss of RMB 316,590,000 for the year ended December 31, 2024, an improvement from a loss of RMB 379,459,000 in the previous year[127]. - The total comprehensive loss for the year was RMB 316,600,000, compared to RMB 379,631,000 in the previous year, indicating a reduction in overall losses[127]. - The company’s basic and diluted loss per share improved to RMB 0.84 in 2024 from RMB 1.05 in 2023[127]. - The net loss for the year decreased from RMB 379.5 million for the year ended December 31, 2023, to RMB 316.6 million for the year ending December 31, 2024[67]. - Adjusted net loss for the year was RMB 254.98 million for 2024, compared to RMB 281.84 million for 2023[69]. Research and Development - Research and development expenses increased by 10.6% to RMB 322.8 million for the year ended December 31, 2024, up from RMB 291.9 million for the previous year, driven by increased preclinical and CMC expenses of RMB 43.6 million and salary-related costs due to team expansion of RMB 7.4 million[14]. - The company has a robust pipeline with over ten innovative drug candidates and 11 ongoing clinical projects, reflecting its commitment to advancing cancer immunotherapy[15]. - The company is preparing IND submissions for IMM01 for atherosclerosis treatment and anticipates IND approval for IMM72/IMC-003 by June 2025[11]. - The company has initiated dosing for the first patient in the systemic lupus erythematosus (SLE) Phase II trial in October 2024, with recruitment for the second dose group expected to start in February 2025[11]. - The company received IND approval for the lupus nephritis (LN) Phase II trial in December 2024 and plans to submit an IND application to the FDA for SLE in the second half of 2025[11]. - The company has completed the IND pre-submission for IMM72/IMC-003 and anticipates receiving IND approval by June 2025[51]. Collaborations and Agreements - The company entered into a licensing and collaboration agreement with Axion Bio, Inc. on August 1, 2024, which includes potential payments of up to $50 million and additional milestone payments of up to $2.1 billion[12]. - As of December 31, 2024, the company has received upfront and recent payments totaling $15 million[13]. - The company has received IND approval for multiple clinical trials, including those for IMM2510 and IMM27M, indicating ongoing expansion of its clinical pipeline[7][8]. Corporate Governance and Compliance - The company is currently reviewing and enhancing its corporate governance practices to ensure compliance with the corporate governance code[89]. - The company has confirmed compliance with the code of conduct regarding securities trading by directors and employees during the reporting period[90]. - The board believes that the current structure of having the same individual serve as both Chairman and CEO is beneficial for leadership consistency and effective strategy execution[88]. Cash Management and Financial Position - Cash and cash equivalents increased to RMB 752.1 million as of December 31, 2024, from RMB 608.6 million as of December 31, 2023, primarily due to an increase in revenue of RMB 73.7 million[74]. - Current assets amounted to RMB 867.9 million as of December 31, 2024, including cash and cash equivalents of RMB 477.6 million[74]. - The company has unutilized tax losses amounting to RMB 1,811,969,000 as of December 31, 2024, compared to RMB 1,446,377,000 in 2023[150]. - The company has no significant acquisitions or disposals of subsidiaries, associates, or joint ventures during the reporting period, aside from the aforementioned sale[72]. - The company has implemented internal control policies and procedures for cash management to optimize the use of excess cash[77]. Share Capital and Offerings - The company has issued a total of 407,307,695 shares, increasing from 374,157,695 shares, with H shares rising from 349,013,299 to 382,163,299 shares[92]. - The net proceeds from the global offering amounted to approximately HKD 251.3 million, after deducting underwriting commissions and related costs[93]. - The company plans to convert a total of 14,114,006 unlisted shares into H shares, pending approval from the China Securities Regulatory Commission[91]. - The company has completed a placement agreement for 33,150,000 new H-shares at a price of HKD 7.05 per share, raising approximately HKD 229.7 million net of expenses[111].
宜明昂科-B(01541) - 2024 - 年度业绩