Clinical Trials and Efficacy - As of December 31, 2024, the clinical follow-up median time for IMM01 combined with Azacitidine as first-line treatment for high-risk Myelodysplastic Syndromes (MDS) reached 26.0 months, with an overall response rate (ORR) of 64.7%[12] - In the Phase II clinical trial for Chronic Myelomonocytic Leukemia (CMML), the median follow-up time was 21.0 months, achieving an ORR of 72.7%[13] - The Phase II trial for IMM01 combined with Tislelizumab in relapsed/refractory classical Hodgkin Lymphoma (cHL) reported an ORR of 69.7% and a complete response rate (CRR) of 24.2%[14] - The company has recruited a total of 107 patients for the clinical trial of IMM2510, showing promising efficacy and good safety profile[15] - As of December 31, 2024, the clinical trial of Amurivap α in combination with lenalidomide for R/R follicular lymphoma (FL) and marginal zone lymphoma (MZL) showed an overall response rate (ORR) of 90.9% and a complete response rate (CRR) of 27.3% among 11 evaluable patients[16] - The Phase II trial of IMM01 in combination with azacitidine for chronic myelomonocytic leukemia (CMML) reported an ORR of 72.7% among 22 evaluable patients, with results selected for presentation at ESMO 2024[22] - The company has initiated a Phase III clinical trial for IMM01 in combination with Tislelizumab for relapsed or refractory classical Hodgkin lymphoma (cHL), with 33 evaluable patients showing an ORR of 69.7%[22] - The company has initiated the IMM2510-002 study, combining IMM2510 with IMM27M for the treatment of relapsed/refractory solid tumors, with the first patient dosed in July 2024[26] - The company has received IND approval for the lupus nephritis (LN) Phase II trial and is preparing to submit an IND application for systemic lupus erythematosus (SLE) expected in the second half of 2025[32] - The company has initiated the first patient dosing in the Phase II trial for neuromyelitis optica spectrum disorder (NMOSD) as of December 2024[32] - The company has observed promising anti-tumor activity and manageable safety in the ongoing clinical trials, with detailed data expected to be disclosed at an international oncology conference in 2025[32] Business Development and Collaborations - The company achieved significant business development breakthroughs, including large international collaborations in 2024[11] - A licensing and collaboration agreement was reached with Axion Bio, Inc., allowing the introduction of proprietary PD-L1xVEGF bispecific molecule Amurivap α in Greater China, with potential payments up to $2.1 billion in development and commercial milestones, plus royalties on global sales[18] - The company is actively pursuing partnerships to expand its global market presence while continuing internal drug development efforts[19] - The company has established a collaboration agreement with Axion Bio, Inc., which includes potential payments of up to $50 million and additional milestone payments of up to $2.1 billion[30] Financial Performance - The company reported revenue of RMB 741 million for the year ending December 31, 2024, an increase of RMB 737 million compared to RMB 4 million for the year ending December 31, 2023, primarily due to upfront and milestone payments from the collaboration agreement with Axion Bio, Inc.[33] - 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 previous year, primarily driven by licensing fees from the agreement with Axion Bio, Inc.[87] - The company reported a net loss of RMB 316.6 million for the year ended December 31, 2024, down from a loss of RMB 379.5 million in 2023[97] - Research and development expenses increased by 10.6% to RMB 322.8 million for the year ending December 31, 2024, compared to RMB 291.9 million for the previous year, mainly due to increased preclinical and CMC expenses[93] - Administrative expenses decreased by 19.4% from RMB 80.4 million in 2023 to RMB 64.8 million in 2024, attributed to a reduction in share-based payments[94] - The net cash used in operating activities for the year ended December 31, 2024, was RMB 128.0 million, a significant decrease from RMB 367.6 million in 2023[107] - The company's debt-to-asset ratio increased to 26.4% as of December 31, 2024, up from 14.4% in 2023, primarily due to an increase in bank borrowings of RMB 55.4 million[109] Product Pipeline and Development - The company has a pipeline of over ten innovative drug candidates and eleven ongoing clinical projects, reflecting its deep understanding of cutting-edge tumor biology and immunology[5] - The company is focused on developing innovative tumor immunotherapies and has made substantial progress in its pipeline products in 2024[11] - The new candidate drug IMM72/IMC-003 for pulmonary arterial hypertension (PAH) has received IND acceptance, with further development of the bispecific molecule IMM7220/IMC-010 for weight loss and muscle gain currently in animal testing[17] - The product pipeline includes several candidates in different stages, with a focus on innovative therapies targeting immune and metabolic diseases[36] - The company is actively exploring the therapeutic potential of IMM01 in other indications and seeking collaboration opportunities[38] Management and Governance - The company has appointed several experienced professionals to its board, enhancing its governance and strategic oversight capabilities[129] - The board includes independent directors who provide independent advice and oversight, ensuring compliance and strategic direction[129] - The company aims to leverage its leadership team's extensive experience to drive innovation and market expansion in the biopharmaceutical industry[130] - The company has a supervisory board consisting of three members, with Ms. Tian serving as the chair since September 2024[138] Future Plans and Strategic Focus - The company plans to advance its core product, IMM01 (Tidepacitib), into Phase III clinical trials in 2025, with a median follow-up of 26 months showing an ORR of 64.7% in high-risk myelodysplastic syndromes (MDS)[22] - The company anticipates rapid progress in 2025, including the disclosure of interim data for several ongoing clinical trials in both oncology and non-oncology areas[19] - The company plans to optimize its strategic asset portfolio and enhance cash flow through the recent sale, aligning with its future development needs[102] - The company plans to expand its overseas footprint and develop tumor immunotherapy to capture significant market opportunities[85] Use of Proceeds from Global Offering - 40% of the net proceeds (HKD 100.5 million) is allocated to fund the core product IMM01, specifically for ongoing and planned clinical trials in China[189] - 28% of the net proceeds (HKD 70.4 million) is designated for funding core products IMM0306, IMM2902, and IMM2520, with specific trials planned in China and the US[189] - The company plans to allocate 10% of the net proceeds (HKD 25.1 million) for clinical trials of IMM47[189] - The remaining balance of unutilized net proceeds is HKD 66.6 million as of December 31, 2024[189] - The board believes that the proposed changes in the use of proceeds will enhance the company's R&D capabilities and align with shareholder interests[197]
宜明昂科-B(01541) - 2024 - 年度财报