Clinical Trials and Drug Development - IMM01 achieved an overall response rate (ORR) of 64.7% (33/51) and a complete response rate (CRR) of 29.4% (15/51) in a Phase II clinical trial for high-risk myelodysplastic syndromes (MDS) as of December 31, 2023[2]. - In the same trial, patients treated for ≥6 months showed an ORR of 89.3% (25/28) and a CRR of 53.6% (15/28), indicating improved efficacy with longer treatment duration[2]. - The company completed patient recruitment for the Phase II trial of IMM01 in chronic myelomonocytic leukemia (CMML), achieving an ORR of 72.7% (16/22) and a CRR of 27.3% (6/22) as of December 31, 2023[3]. - The FDA granted orphan drug designation for IMM01 in combination with azacitidine for the treatment of CMML in November 2023[3]. - The company initiated a Phase II clinical trial for IMM2510 in soft tissue sarcoma (STS) in November 2023, with a recommended Phase II dose (RP2D) established at 20 mg/kg[4]. - As of December 31, 2023, preliminary data from the IMM2510 trial showed 3 patients achieved partial response (PR) and 7 patients had stable disease (SD)[4]. - IMM0306 demonstrated an overall response rate (ORR) of 71.4% and a disease control rate (DCR) of 85.7% in an ongoing Phase Ib/IIa trial for relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma (B-NHL)[3]. - The company received IND approval for IMM2510 in combination with chemotherapy for NSCLC or triple-negative breast cancer (TNBC) in November 2023[4]. - As of December 31, 2023, the company has recruited and dosed a total of 12 patients in the Phase I study of IMM2520, with preliminary data indicating safety and tolerability[4]. - The company is conducting dose escalation studies for IMM2902 (CD47 × HER2) in China, currently in the seventh cohort at a dose of 4.0 mg/kg[5]. - The first patient in the IMM47 Phase I clinical trial was dosed in Australia in September 2023, with IND approvals received from the National Medical Products Administration and the FDA for treating advanced malignancies[5]. - The company plans to submit an IND application for IMC-002 (IMM0306) for autoimmune indications to the National Medical Products Administration by March 2024[5]. - The company has completed efficacy studies in a mouse model for pulmonary arterial hypertension (PAH) and observed preliminary effectiveness in skeletal muscle increase[5]. - The company has completed candidate drug screening and concept validation studies for IMM7211 (ACTRIIA × undisclosed target bispecific molecule) and is currently developing cell lines[5]. - The company has over ten innovative drug candidates and eight ongoing clinical projects, reflecting a strong pipeline based on innate immunity[7]. - The Phase II clinical trial for IMM01 combined with Azacitidine in high-risk MDS patients recruited 57 patients, achieving an overall response rate (ORR) of 64.7%[11]. - In the same trial, for patients treated for at least 6 months, the ORR increased to 89.3%[11]. - The Phase II trial for IMM01 combined with Azacitidine in CMML patients recruited 24 patients, with an ORR of 72.7%[14]. - For patients treated for at least 6 months in the CMML trial, the ORR was 84.6%[14]. - The combination of IMM01 and Tislelizumab in R/R cHL patients showed an ORR of 66.7% with a complete response rate (CRR) of 24.2%[17]. - The company plans to complete the Phase II trial for IMM01 and Tislelizumab by 2024 and has submitted an application for a Phase III trial[17]. - IMM0306, a bispecific molecule targeting CD47 and CD20, has recruited 48 patients with no dose-limiting toxicities observed[24]. - The recommended phase 2 dose (RP2D) for IMM0306 was determined to be 2.0 mg/kg, with 5 complete responses (CR) and 5 partial responses (PR) observed[24]. - In the ongoing Ib/IIa clinical trial of IMM0306 combined with lenalidomide, 8 patients were recruited, showing an overall response rate (ORR) of 71.4% and a disease control rate (DCR) of 85.7%[29]. - The recommended Phase II dose (RP2D) for IMM2510 has been established at 20 mg/kg, with promising anti-tumor activity observed in patients with R/R NSCLC and thymic squamous cell carcinoma[37]. - As of December 31, 2023, three confirmed partial responses (PR) were observed in patients treated with IMM2510, with tumor reductions of 46%, 32%, and over 53%[38]. - The IND application for IMM2510 combined with chemotherapy for NSCLC or TNBC has been approved, with trials expected to start in Q2 2024[44]. - The Phase I trial of IMM27M has shown safety and tolerability up to 7.5 mg/kg, with a recommended Phase II dose of 5 mg/kg[46]. - In the IMM27M trial, a patient with hormone receptor-positive breast cancer showed a tumor reduction of 62.5% at a dose of 3 mg/kg, with a duration of response exceeding 9 months[46]. - The Phase I trial of IMM2520 has recruited 12 patients, with preliminary data indicating safety and tolerability up to 2.0 mg/kg[52]. - Among 10 evaluable patients in the IMM2520 trial, three achieved stable disease (SD) with tumor reductions exceeding 10%[53]. - The company plans to complete the IMM2520 trial by 2024 and is considering potential collaboration opportunities in the U.S.[53]. - IMM2902 is currently in the dose escalation phase of a clinical trial for advanced HER2-positive and HER2-low expressing solid tumors, with the 7th cohort at a dose of 4.0 mg/kg, expected to complete by the end of 2024[54]. - IMM47 received IND approvals from the National Medical Products Administration and the FDA for treating advanced malignancies and R/R B-NHL, with the first patient dosed in Australia in September 2023[55][56]. Financial Performance - Total revenue for the year ended December 31, 2023, was RMB 0.4 million, a decrease of 20% from RMB 0.5 million in 2022, primarily from cell line sales and testing services[60]. - Other income increased from RMB 14.7 million in 2022 to RMB 18.2 million in 2023, driven by a RMB 2.2 million increase in government grants and a RMB 1.3 million increase in bank interest income[61]. - The company reported a net gain of RMB 1.8 million for the year ended December 31, 2023, compared to a loss of RMB 29.4 million in 2022, mainly due to a reduction in losses from financial liabilities measured at fair value[62]. - R&D expenses increased by 5.3% from RMB 277.3 million in 2022 to RMB 291.9 million in 2023, primarily due to an increase in clinical trial expenses by RMB 24.9 million and salary-related costs by RMB 12.2 million[64]. - Clinical trial expenses rose to RMB 120.6 million in 2023 from RMB 95.7 million in 2022, reflecting progress in clinical candidates[64]. - Administrative expenses decreased by 13.3% from RMB 92.8 million in 2022 to RMB 80.4 million in 2023, mainly due to a reduction in share-based payments[65]. - The net loss for the year decreased from RMB 402.9 million in 2022 to RMB 379.5 million in 2023[67]. - Cash and cash equivalents totaled RMB 608.6 million as of December 31, 2023, down from RMB 635.2 million in 2022, primarily due to cash outflows from operations and R&D activities[70]. - Net cash used in operating activities increased to RMB 367.6 million in 2023 from RMB 238.7 million in 2022, driven by business expansion and progress in clinical trials[70]. - Cash used in investing activities rose significantly to RMB 294.8 million in 2023 from RMB 49,000 in 2022, mainly due to purchases of financial assets[71]. - Financing activities generated net cash of RMB 331.0 million in 2023, an increase from RMB 179.4 million in 2022, primarily due to proceeds from a global offering and unsecured bank loans[71]. - The company had approximately RMB 80.0 million in undrawn bank loan facilities as of December 31, 2023[71]. - No significant acquisitions or disposals of subsidiaries, associates, or joint ventures occurred during the year ended December 31, 2023[70]. - As of December 31, 2023, the company's debt-to-asset ratio increased to 14.4%, up from 7.2% as of December 31, 2022, primarily due to an increase in bank borrowings of RMB 60.0 million[72]. - The company has unsecured bank borrowings of RMB 60.0 million as of December 31, 2023, with interest rates ranging from 3.0% to 3.4%[73]. - Total employee compensation for the year ended December 31, 2023, was RMB 155.7 million, a decrease from RMB 173.1 million for the year ended December 31, 2022, mainly due to a reduction in restricted shares[76]. - The company has capital commitments of RMB 6.0 million as of December 31, 2023, compared to RMB 5.7 million as of December 31, 2022, reflecting capital expenditures for property and equipment[74]. - The company recorded fair value gains from structured financial products totaling RMB 1,329,000, RMB 462,000, RMB 554,000, and RMB 175,000 during the reporting period[78]. - The net proceeds from the issuance of 17,147,200 H-shares at HKD 18.60 per share amounted to approximately HKD 251.3 million after deducting underwriting commissions and related costs[83]. - The company has no contingent liabilities or pledged assets as of December 31, 2023[75]. - The company maintains a stable lease liability of RMB 14.8 million as of December 31, 2023, compared to RMB 14.6 million as of December 31, 2022[73]. - The company has adopted a code of conduct for securities trading by directors and employees, confirming compliance from the listing date to December 31, 2023[80]. - For the core product IMM01, 40.0% of the funds raised (HKD 100.5 million) is allocated, with HKD 22.8 million utilized and HKD 77.7 million remaining as of December 31, 2023[84]. - For core products IMM0306, IMM2902, and IMM2520, 28.0% of the funds raised (HKD 70.4 million) is allocated, with HKD 21.6 million utilized and HKD 48.8 million remaining[85]. - The company plans to utilize the remaining funds from the global offering by the end of 2025, with HKD 59.4 million already utilized as of December 31, 2023[86]. - The total revenue for the year ended December 31, 2023, was RMB 386.538 million, compared to RMB 386.538 million in 2022[95]. - The net loss for the year ended December 31, 2023, was RMB 379.459 million, a slight improvement from a net loss of RMB 402.894 million in 2022[95]. - Research and development expenses for the year were RMB 291.944 million, compared to RMB 277.346 million in 2022, indicating an increase in investment in R&D[95]. - The company reported a basic and diluted loss per share of RMB 1.05 for the year ended December 31, 2023, compared to RMB 1.21 in 2022[95]. - The company has not recommended a final dividend for the year ended December 31, 2023, consistent with the previous year[93]. - The audit committee has reviewed the financial performance for the year ended December 31, 2023, ensuring compliance with relevant accounting standards[87]. - The company plans to expand its clinical trials for various products, including IMM0306 and IMM2902, targeting specific cancers in China and the US[85]. - Total revenue for the year ended December 31, 2023, was RMB 386,000, a decrease of 28.3% compared to RMB 538,000 in 2022[100]. - The company reported a net loss attributable to owners of RMB 379,459,000 for the year ended December 31, 2023, compared to a loss of RMB 402,894,000 in 2022[109]. - Cash and cash equivalents decreased to RMB 306,983,000 as of December 31, 2023, down from RMB 635,212,000 in 2022, representing a decline of 51.7%[96]. - Non-current assets totaled RMB 187,890,000 as of December 31, 2023, slightly down from RMB 188,107,000 in 2022[96]. - The company received government grants amounting to RMB 7,309,000 in 2023, an increase of 41.8% from RMB 5,152,000 in 2022[105]. - The company’s total assets less current liabilities were RMB 758,682,000 as of December 31, 2023, compared to RMB 788,241,000 in 2022, indicating a decrease of 3.8%[96]. - The company’s equity totaled RMB 748,287,000 as of December 31, 2023, down from RMB 779,221,000 in 2022, reflecting a decline of 4.0%[96]. - Depreciation expenses for property and equipment and right-of-use assets amounted to RMB 22,583,000 in 2023, an increase from RMB 17,617,000 in 2022[107]. - The company’s trade and other payables increased to RMB 51,530,000 in 2023 from RMB 46,138,000 in 2022, representing an increase of 11.0%[96]. - The company plans to continue its focus on research and development in tumor immunotherapy, leveraging government support for R&D activities[97]. - The company reported a basic and diluted loss per share of RMB (1.05) for the year ended December 31, 2023, compared to RMB (1.21) for the previous year[110]. - No dividends were declared or paid to ordinary shareholders for 2023, consistent with 2022[112]. - Trade receivables aged analysis shows RMB 35,111 thousand within 30 days and RMB 2,627 thousand between 31 to 60 days as of December 31, 2023[113]. - Other receivables include RMB 909 thousand in interest receivable and RMB 76,769 thousand for procurement and R&D services as of December 31, 2023[114]. - Trade and other payables totaled RMB 51,530 thousand as of December 31, 2023, an increase from RMB 46,138 thousand in 2022[115]. - The average credit period for procurement of goods/services is 45 days[115]. - Trade payables aged analysis indicates RMB 10,746 thousand within 30 days and RMB 42 thousand between 31 to 90 days as of December 31, 2023[116]. - The company had no issued potential dilutive ordinary shares during the year, thus no adjustments were made to the basic earnings per share for the year ended December 31, 2023[111]. - The company has not proposed any dividend payments since its listing on September 5, 2023[118]. - The company underwent a capital restructuring on June 14, 2022, issuing 356,092,695 shares with a par value of RMB 1 each[110].
宜明昂科-B(01541) - 2023 - 年度业绩