Clinical Trials and Drug Development - As of June 30, 2024, the overall response rate (ORR) for IMM01 combined with Azacitidine as a first-line treatment for Chronic Myelomonocytic Leukemia (CMML) reached 72.7% (16/22), with a complete response rate (CRR) of 27.3% (6/22) among evaluable patients [3]. - For patients treated for at least 4 months, the ORR for IMM01 combined with Azacitidine in higher-risk Myelodysplastic Syndromes (MDS) was 85.3% (29/34), with a CRR of 50.0% (17/34) as of June 30, 2024 [3]. - The company received approval for the Phase III clinical trial of IMM01 combined with Pembrolizumab for PD-(L)1 refractory classical Hodgkin Lymphoma (cHL) in April 2024, with the first patient dosed on July 1, 2024 [4]. - The company initiated the Phase I clinical trial for IMM2510 in September 2023, enrolling 33 patients with advanced/metastatic solid tumors, showing promising anti-tumor activity [5]. - As of June 30, 2024, the ORR for IMM0306 combined with Lenalidomide in R/R CD20 positive B-cell Non-Hodgkin Lymphoma (B-NHL) was 90.9% (10/11), with a CRR of 27.3% (3/11) [4]. - The company completed patient recruitment for the Phase I trial of IMM27M in September 2023, with initial data indicating good safety and tolerability [5]. - The company reported that among patients treated for at least 6 months with IMM01 in higher-risk MDS, the ORR was 89.7% (26/29) and the CRR was 58.6% (17/29) as of June 30, 2024 [3]. - The company has initiated the Phase I trial for IMM2520 in multiple advanced solid tumors, with 24 patients enrolled as of June 30, 2024, showing initial safety and tolerability [5]. - The company plans to complete the IMM2520 trial by the end of 2024, with preliminary data showing one partial response and two stable disease cases [5]. - The company has made significant progress in its drug pipeline, with multiple clinical trials ongoing and new product developments expected in the near future [2]. - The company has initiated Phase II trials for the CD47xCD20 bispecific antibody starting in Q2 2023 [9]. - The company has received IND approval for IMM47 (CD24 monoclonal antibody) in October and December 2023 in China and the US, with Phase I trials commencing in September 2023 in Australia [9]. - The company has completed patient recruitment for the Phase II clinical trial of IMM01 combined with Azacitidine, enrolling 57 patients [12]. - The company has initiated a Phase II trial for IMM2510 in combination with chemotherapy for solid tumors, with IND approval received in November 2023 [48]. - IMM0306, a bispecific molecule targeting CD47 and CD20, has recruited 48 patients with no dose-limiting toxicities observed, achieving a CR in 5 patients and a PR in 5 patients [27]. - The company has observed preliminary efficacy in mouse models for IMC-003, a next-generation ACTRIIA fusion protein, with expectations to submit an IND application within a year [56]. - IMM2902 is currently in the dose escalation phase of clinical trials for advanced HER2-positive and HER2-low expressing solid tumors, with the 8th cohort at a dose of 5.0 mg/kg [52]. Financial Performance - Loss for the six months ended June 30, 2024, was RMB 165.8 million, a decrease of RMB 5.0 million compared to RMB 170.8 million for the six months ended June 30, 2023, mainly due to the reduction in R&D expenses [7]. - Adjusted loss increased by RMB 4.9 million to RMB 120.7 million for the six months ended June 30, 2024, compared to RMB 115.8 million for the six months ended June 30, 2023, primarily due to an increase in administrative expenses [7]. - Revenue for the six months ended June 30, 2024, was RMB 77,000, a decrease of 10.5% from RMB 86,000 for the same period in 2023 [61]. - Other income decreased from RMB 6,359,000 in the six months ended June 30, 2023, to RMB 4,277,000 in the same period in 2024, primarily due to a reduction in bank interest income by RMB 1,644,000 [62]. - Research and development expenses decreased by 7.0% from RMB 128.1 million for the six months ended June 30, 2023, to RMB 119.1 million for the six months ended June 30, 2024, primarily due to a reduction in clinical trial expenses by RMB 11.7 million and a decrease in share-based payment expenses by RMB 9.0 million [7]. - The company recorded a significant impairment loss of RMB 27,398,000 on property and equipment during the six months ended June 30, 2024 [63]. - The company’s total equity as of June 30, 2024, was RMB 600,238,000 (thousand), down from RMB 748,287,000 (thousand) at the end of 2023 [91]. - The total comprehensive loss for the period was RMB 165,750,000 (thousand), compared to RMB 170,748,000 (thousand) in the previous year, indicating a decrease of 2.92% [90]. - Basic and diluted loss per share was RMB 0.44, an improvement from RMB 0.48 in the same period of the previous year [90]. - The company did not recommend the payment of an interim dividend for the six months ending June 30, 2024, consistent with the previous year [87]. Strategic Initiatives and Collaborations - The company entered into a licensing and collaboration agreement with SynBioTx Inc. on August 1, 2024, for the global rights (excluding Greater China) to its proprietary PD-L1xVEGF bispecific molecule IMM2510 and a next-generation anti-CTLA-4 antibody (ADCC+) IMM27M, receiving an upfront payment of $10 million [6]. - The potential near-term payments from the agreement with SynBioTx could exceed $40 million, along with potential additional development, regulatory, and commercial milestone payments of up to $2.1 billion [6]. - The company plans to explore the therapeutic potential of IMM01 in additional indications and seek collaboration opportunities [11]. - The company aims to expand its market presence through strategic initiatives and potential mergers and acquisitions [112]. - The company plans to expand its overseas footprint and accelerate clinical research in China to leverage market opportunities [60]. - The company aims to enhance its pipeline by evaluating innovative therapies targeting other innate immune checkpoints [60]. Corporate Governance and Compliance - The company has confirmed compliance with the corporate governance code, although the roles of Chairman and CEO are held by the same individual, Dr. Tian [79]. - The audit committee has reviewed the interim financial performance for the six months ending June 30, 2024, and discussed financial reporting matters with management [85]. - The company is committed to enhancing its corporate governance practices to ensure compliance with applicable codes [80]. - The company operates under the International Financial Reporting Standards, ensuring compliance and transparency in financial reporting [112]. - The company has established a standard code for securities trading among its directors, promoting ethical practices [112]. - The board of directors includes a diverse team with both executive and independent non-executive members, ensuring a balanced governance structure [113]. Assets and Liabilities - As of June 30, 2024, the company's cash and cash equivalents totaled RMB 513.0 million, down from RMB 608.6 million as of December 31, 2023, primarily due to cash outflows for daily operations and R&D activities [71]. - The company's total current assets as of June 30, 2024, amounted to RMB 582.6 million, which includes financial assets at fair value of RMB 266.2 million and cash and cash equivalents of RMB 246.8 million [71]. - The company's debt-to-asset ratio increased to 19.2% as of June 30, 2024, from 14.4% as of December 31, 2023, mainly due to an increase in bank borrowings of RMB 26.0 million [73]. - As of June 30, 2024, the company had unutilized bank loan facilities of approximately RMB 90.0 million [72]. - The company has no contingent liabilities or pledged assets as of June 30, 2024 [76]. - The company has a single operating segment, and no further analysis of this segment is provided in the report [100].
宜明昂科-B(01541) - 2024 - 中期业绩