IMM01 Clinical Trial Results - IMM01 combined with azacitidine achieved an ORR of 72.7% (16/22) and CRR of 27.3% (6/22) in CMML patients, with ORR increasing to 87.5% (14/16) and CRR to 37.5% (6/16) in patients treated for ≥4 months[5] - IMM01 combined with azacitidine achieved an ORR of 64.7% (33/51) and CRR of 33.3% (17/51) in HR MDS patients, with ORR increasing to 85.3% (29/34) and CRR to 50.0% (17/34) in patients treated for ≥4 months[5] - IMM01 combined with tislelizumab achieved an ORR of 66.7% and CRR of 24.2% in R/R cHL patients, with 8 CRs and 14 PRs observed in 33 evaluable patients[5] - IMM01 combined with azacitidine demonstrated an ORR of 85.3% (29/34) in MDS patients treated for ≥4 months, with 50.0% (17/34) achieving CR[19] - IMM01 combined with azacitidine demonstrated an ORR of 87.5% (14/16) in CMML patients treated for ≥4 months, with 37.5% (6/16) achieving CR[21] - IMM01 combined with azacitidine demonstrated an ORR of 89.7% (26/29) in MDS patients treated for ≥6 months, with 58.6% (17/29) achieving CR[19] - IMM01 combined with azacitidine demonstrated an ORR of 84.6% (11/13) in CMML patients treated for ≥6 months, with 46.2% (6/13) achieving CR[21] - IMM01 combined with tislelizumab showed no treatment-related adverse events leading to drug discontinuation or death in R/R cHL patients[23] IMM0306 Clinical Trial Results - IMM0306 combined with lenalidomide achieved an ORR of 90.9% and CRR of 27.3% in R/R B-NHL patients, with 3 CRs and 7 PRs observed in 11 evaluable patients[7] - IMM0306 monotherapy showed 5 CRs, 5 PRs, and 11 SDs in 48 patients who had previously received anti-CD20 therapy[27] - IMM0306 combined with lenalidomide showed an ORR of 90.9% and CRR of 27.3% in Ib phase trials, with 3 CR and 7 PR cases observed[30] - IMM0306 combined with lenalidomide in IIa phase trials showed an ORR of 100% and CRR of 66.7% in R/R FL patients[30] - IMM0306 monotherapy determined the RP2D to be 2.0 mg/kg with no dose-limiting toxicities observed[27] IMM2510 Clinical Trial Results - IMM2510 demonstrated promising anti-tumor activity with 3 confirmed PRs and 7 SDs, including 4 patients with tumor shrinkage >15%, in 33 advanced/metastatic solid tumor patients[8] - IMM2510 Phase I trial recruited 33 patients with no dose-limiting toxicity observed, and 3 confirmed PR cases were reported as of June 30, 2024[34] - IMM2510 combined with chemotherapy received IND approval for Phase II trials in November 2023[37] IMM27M Clinical Trial Results - IMM27M showed safety and tolerability in heavily pretreated advanced solid tumor patients, with 2 confirmed PRs observed[9] - IMM27M Phase I trial completed patient recruitment in September 2023, with 2 confirmed PR cases and 3 SD cases with tumor shrinkage observed[38] IMM2520 Clinical Trial Results - IMM2520 demonstrated safety and tolerability in 24 advanced solid tumor patients, with 1 PR and 2 SDs with tumor shrinkage >10% observed[10] - IMM2520 Phase I trial recruited 24 patients as of June 30, 2024, with 1 PR and 2 SD cases with tumor shrinkage over 10% observed[40] IMC Series Development - IMC-002 received IND approvals for treating systemic lupus erythematosus (SLE) and neuromyelitis optica spectrum disorder (NMOSD) in June 2024[11] - IMC-001 is currently in IND preparation for treating atherosclerosis[11] - IMC-003 (ACTRIIA fusion protein) completed efficacy studies in a pulmonary arterial hypertension (PAH) mouse model, showing preliminary efficacy in increasing skeletal muscle[12] - IMC-004 (ACTRIIA × undisclosed target bispecific molecule) is undergoing in vivo efficacy studies and cell line development[13] - IMC-002 (IMM0306), a bispecific molecule targeting CD47 and CD20, received IND approvals for the treatment of systemic lupus erythematosus (SLE) and neuromyelitis optica spectrum disorder (NMOSD) in June 2024[43] - IMC-001 (IMM01), the first SIRPα-Fc fusion protein to enter clinical trials in China, is preparing for IND submission for the treatment of atherosclerosis[44] - IMC-003 (ACTRIIA fusion protein) has completed CMC development and is expected to submit an IND application within one year[45] - IMC-004, a bispecific molecule targeting ACTRIIA and an undisclosed target, is undergoing in vivo efficacy studies and cell line development for the treatment of osteoporosis and muscle mass increase[46] Licensing and Collaboration Agreements - The company entered a licensing and collaboration agreement with SynBioTx Inc. in August 2024, receiving an upfront payment of 2.1 billion, plus royalties on net sales outside Greater China[13] - The company signed an exclusive licensing and collaboration agreement with SynBioTx Inc. on August 1, 2024, granting rights for research, development, and commercialization of certain PD-L1 and VEGF bispecific antibodies (including IMM2510) and CTLA-4 monoclonal antibodies (including IMM27M) outside Greater China[152] - The company will retain development and commercialization rights for the licensed products within Greater China, including Mainland China, Hong Kong SAR, Macau SAR, and Taiwan[152] - The company will receive upfront payments, potential near-term payments, and milestone payments for commercial, development, and regulatory achievements, along with single-digit to low double-digit percentage royalties on net sales outside Greater China[153] - Royalty payments will continue on a product-by-product and country-by-country basis until the later of 10 years after first commercial sale, patent expiration, or regulatory exclusivity expiration[153] Financial Performance - R&D expenses decreased by 7.0% to RMB 119.1 million in the first half of 2024, primarily due to reduced clinical trial costs and lower share-based payments[14] - Net loss for the first half of 2024 was RMB 165.8 million, a decrease of RMB 5.0 million compared to the same period in 2023, mainly due to reduced R&D expenses[14] - Adjusted net loss increased by RMB 4.9 million to RMB 120.7 million in the first half of 2024, driven by higher administrative expenses[15] - Total revenue for the six months ended June 30, 2024, was RMB 77,000, compared to RMB 86,000 for the same period in 2023[50] - Other income decreased from RMB 6.4 million for the six months ended June 30, 2023, to RMB 4.3 million for the same period in 2024, primarily due to a decrease in bank interest income of RMB 1.6 million and a decrease in government grants of RMB 0.4 million[51] - R&D expenses decreased by 7.0% from RMB 128.1 million in the first half of 2023 to RMB 119.1 million in the first half of 2024, primarily due to reduced clinical trial expenses and lower share-based payments[54] - Clinical trial expenses decreased by RMB 11.7 million, mainly due to cost savings and increased utilization of internal resources[54] - Share-based payments decreased by RMB 9.0 million, driven by lower recognized expenses under IFRS[54] - Salaries and related benefits increased by RMB 7.2 million due to the expansion of the clinical team[54] - Preclinical and CMC expenses increased by RMB 4.6 million, driven by the advancement of R&D activities for IMM0306 and IMM2510[54] - Administrative expenses decreased by 27.1% from RMB 41.3 million in the first half of 2023 to RMB 30.1 million in the first half of 2024, mainly due to reduced share-based payments[55] - The company's cash and cash equivalents, term deposits, and financial assets at fair value totaled RMB 513.0 million as of June 30, 2024, down from RMB 608.6 million as of December 31, 2023[60] - The company's asset-to-liability ratio increased to 19.2% as of June 30, 2024, up from 14.4% as of December 31, 2023, primarily due to an increase in bank borrowings[61] - The company's net cash used in operating activities decreased by RMB 9.4 million to RMB 123.0 million in the first half of 2024, mainly due to reduced R&D payments[60] - The company's unsecured bank loans increased to RMB 86.0 million as of June 30, 2024, up from RMB 60.0 million as of December 31, 2023, with fixed interest rates ranging from 3.00% to 3.60%[62] - Lease liabilities remained relatively stable at RMB 11.7 million as of June 30, 2024, compared to RMB 14.8 million as of December 31, 2023[62] - Capital commitments for property and equipment purchases decreased significantly to RMB 0.2 million as of June 30, 2024, from RMB 6.0 million as of December 31, 2023[63] - The company held four redeemable structured note financial products with a total fair value of RMB 266.2 million as of June 30, 2024, representing over 5% of the company's total assets[65] - The company recorded fair value gains of RMB 2.6 million, RMB 826,000, RMB 956,000, and RMB 930,000 on its financial products during the reporting period[65] - The company's total employee count was 150 as of June 30, 2024, with total compensation costs decreasing to RMB 60.8 million for the six months ended June 30, 2024, from RMB 80.1 million for the same period in 2023[66] - Revenue for the six months ended June 30, 2024, was RMB 77 thousand, compared to RMB 86 thousand in the same period in 2023[111] - Net loss for the six months ended June 30, 2024, was RMB 165.76 million, compared to RMB 170.83 million in the same period in 2023[111] - R&D expenses for the six months ended June 30, 2024, were RMB 119.14 million, a decrease from RMB 128.09 million in the same period in 2023[111] - Administrative expenses for the six months ended June 30, 2024, were RMB 30.06 million, down from RMB 41.26 million in the same period in 2023[111] - Basic and diluted loss per share for the six months ended June 30, 2024, was RMB 0.44, compared to RMB 0.48 in the same period in 2023[111] - The company did not recommend the payment of an interim dividend for the six months ended June 30, 2024, consistent with the same period in 2023[107] - The Audit Committee reviewed the unaudited interim financial results for the six months ended June 30, 2024, and found them to comply with applicable accounting standards and regulations[105] - The company did not purchase, sell, or redeem any of its listed securities during the reporting period[106] - Total assets decreased from RMB 758,682 thousand to RMB 623,492 thousand, a decline of 17.8%[113] - Net current assets dropped from RMB 570,792 thousand to RMB 462,820 thousand, a decrease of 18.9%[113] - Cash and cash equivalents fell from RMB 306,983 thousand to RMB 246,848 thousand, a reduction of 19.6%[113] - The company reported a net loss of RMB 165,760 thousand for the six months ended June 30, 2024[114] - Operating cash outflow was RMB 123,017 thousand, slightly improved from RMB 132,356 thousand in the same period last year[115] - Investment activities generated a net cash inflow of RMB 40,266 thousand, compared to a net outflow of RMB 38,402 thousand in the previous year[115] - Financing activities resulted in a net cash inflow of RMB 21,508 thousand, down from RMB 25,630 thousand in the prior year[115] - The company's total equity decreased from RMB 748,287 thousand to RMB 600,238 thousand, a decline of 19.8%[113] - Property, plant, and equipment decreased from RMB 59,157 thousand to RMB 31,886 thousand, a reduction of 46.1%[113] - The company's accumulated losses increased to RMB 876,105 thousand as of June 30, 2024[114] - Revenue from sales of cell lines and other products decreased to RMB 49,000 in the first half of 2024, down from RMB 86,000 in the same period in 2023, representing a 43% decline[120] - Testing services revenue was RMB 28,000 in the first half of 2024, compared to no revenue in the same period in 2023[120] - Total other income decreased to RMB 4,277,000 in the first half of 2024 from RMB 6,359,000 in the same period in 2023, a 32.7% decline[125] - Government grants decreased to RMB 642,000 in the first half of 2024 from RMB 1,038,000 in the same period in 2023, a 38.1% decline[125] - Bank interest income decreased to RMB 3,635,000 in the first half of 2024 from RMB 5,279,000 in the same period in 2023, a 31.1% decline[125] - Net other gains and losses showed a loss of RMB 19,487,000 in the first half of 2024, compared to a gain of RMB 6,106,000 in the same period in 2023[126] - Property and equipment impairment loss was RMB 27,398,000 in the first half of 2024, compared to no impairment loss in the same period in 2023[126] - Total employee costs decreased to RMB 60,846,000 in the first half of 2024 from RMB 80,129,000 in the same period in 2023, a 24.1% decline[127] - Basic and diluted loss per share improved to RMB 0.44 in the first half of 2024 from RMB 0.48 in the same period in 2023[129] - Trade receivables increased to RMB 48,000 as of June 30, 2024, from RMB 39,000 as of December 31, 2023[131] - Prepayments and other receivables decreased to RMB 69,510 thousand as of June 30, 2024, compared to RMB 78,097 thousand as of December 31, 2023[132] - Financial assets at fair value through profit or loss increased to RMB 266,189 thousand as of June 30, 2024, from RMB 259,085 thousand as of December 31, 2023[132] - Cash and cash equivalents decreased to RMB 246,848 thousand as of June 30, 2024, from RMB 306,983 thousand as of December 31, 2023[132] - Trade and other payables for R&D expenses decreased to RMB 4,883 thousand as of June 30, 2024, from RMB 10,804 thousand as of December 31, 2023[135] - Unsecured bank loans increased to RMB 85,990 thousand as of June 30, 2024, from RMB 59,980 thousand as of December 31, 2023[137] - The company issued 18,065,000 ordinary shares with a face value of RMB 1 per share during the global offering and over-allotment exercise in 2023[139] - The company's bank balances were subject to market interest rates ranging from 0.01% to 5.33% as of June 30, 2024[132] - The average credit period for the company's procurement of goods/services is 45 days[135] - The company's trade payables aged 0 to 30 days decreased to RMB 4,461 thousand as of June 30, 2024, from RMB 10,746 thousand as of December 31, 2023[136] - The company's bank loan interest rates ranged from 3.00% to 3.60% per annum as of June 30, 2024[138] - The company's restricted share plan under Jiaxing Changxian Enterprise Management Center (Jiaxing Changxian) had no changes in the six months ended June 30, 2024, with a registered capital of RMB 345,000 (equivalent to RMB 15,525,000 in share capital as of June 30, 2024)[141] - The restricted share plan under Jiaxing Changyu Enterprise Management Center (Jiaxing Changyu) also had no changes in the six months ended June 30, 2024, with a registered capital of RMB 330,000 (equivalent to RMB 14,850,000 in share capital as of June 30, 2024)[141] - The company's restricted share plan under Halo Biomedical Investment II Limited (Halo Investment II) had a registered capital of RMB 400,000 (equivalent to RMB 18,000,000 in share capital as of June 30, 2024)[141] -
宜明昂科-B(01541) - 2024 - 中期财报