Clinical Trial Results - IMM01 combined with azacitidine achieved an ORR of 64.7% (33/51) and a CRR of 29.4% (15/51) in a Phase II clinical trial for high-risk MDS, with ORR increasing to 89.3% (25/28) and CRR to 53.6% (15/28) in patients treated for ≥6 months[6] - IMM01 combined with azacitidine achieved an ORR of 72.7% (16/22) and a CRR of 27.3% (6/22) in a Phase II clinical trial for CMML, with ORR increasing to 84.6% (11/13) and CRR to 46.2% (6/13) in patients treated for ≥6 months[6] - IMM01 combined with tislelizumab achieved an ORR of 66.7% and a CRR of 24.2% in a Phase II clinical trial for R/R cHL, with 8 CRs and 14 PRs observed in 33 evaluable patients[6] - IMM0306 combined with lenalidomide achieved an ORR of 71.4% and a DCR of 85.7% in an ongoing Ib/IIa clinical trial for R/R CD20-positive B-NHL, with 1 CR, 4 PRs, and 1 SD observed in 7 evaluable patients[8] - 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 trial for high-risk myelodysplastic syndrome (MDS) as of December 31, 2023[10] - IMM01 demonstrated an ORR of 72.7% (16/22) and a CRR of 27.3% (6/22) in a Phase II trial for chronic myelomonocytic leukemia (CMML) as of December 31, 2023[10] - IMM01 combined with tislelizumab showed an ORR of 66.7% and a CRR of 24.2% in a Phase II trial for relapsed/refractory classical Hodgkin lymphoma (cHL) as of March 1, 2024[10] - IMM0306 combined with lenalidomide achieved an ORR of 71.4% and a disease control rate (DCR) of 85.7% in a Phase Ib/IIa trial for relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma (B-NHL) as of January 5, 2024[12] - IMM2510 showed promising anti-tumor activity in a Phase I trial, with 3 confirmed partial responses (PR) and 7 stable disease (SD) cases, including tumor shrinkage of over 15% in 4 patients as of December 31, 2023[14] - IMM27M demonstrated safety and tolerability up to 7.5 mg/kg, with 2 confirmed PR cases in heavily pretreated advanced hormone receptor-positive breast cancer patients[15] - IMM2520 showed tumor shrinkage of over 10% in 3 patients, including a 26.3% reduction in a small cell lung cancer (SCLC) patient after 4 treatment cycles as of January 2024[16] - IMM01 combined with azacitidine achieved an ORR of 64.7% (33/51) in high-risk MDS patients, with 29.4% (15/51) achieving CR and 15.7% achieving mCR+HI[26] - In CMML patients, IMM01 combined with azacitidine showed an ORR of 72.7% (16/22), with 27.3% (6/22) achieving CR and 13.6% achieving mCR+HI[27] - IMM01 combined with tislelizumab achieved an ORR of 66.7% (22/33) in R/R cHL patients, with 24.2% (8/33) achieving CR[29] - IMM0306, a CD47×CD20 bispecific molecule, showed 5 CRs and 5 PRs in 48 patients treated with doses between 0.8 mg/kg to 2 mg/kg[33] - IMM01 combined with azacitidine demonstrated an ORR of 85.3% (29/34) in high-risk MDS patients treated for ≥4 months, with a CRR of 44.1% (15/34)[26] - In CMML patients treated for ≥4 months, IMM01 combined with azacitidine achieved an ORR of 87.5% (14/16) and a CRR of 37.5% (6/16)[27] - IMM0306 combined with lenalidomide showed an ORR of 71.4% and a DCR of 85.7% in R/R FL and MZL patients at a dose of 1.6 mg/kg, with 1 CR, 4 PR, and 1 SD observed in 7 evaluable patients[36] - IMM2510 monotherapy demonstrated promising anti-tumor activity with 3 confirmed PRs and 7 SDs, including tumor shrinkage of 46%, 32%, and 53% in NSCLC and thymic squamous carcinoma patients[40] - IMM27M showed 2 confirmed PRs with tumor shrinkage of 62.5% and 41.0% in hormone receptor-positive breast cancer patients, and 3 SDs with tumor shrinkage of 22.9%, 18.5%, and 10.3%[44] - IMM2520 (CD47 × PD-L1) demonstrated safety and tolerability up to 2.0 mg/kg, with tumor shrinkage observed in 3 out of 10 evaluable patients, including a 21.1% shrinkage in a cervical cancer patient at 0.1 mg/kg and a 26.3% shrinkage in a SCLC patient at 2.0 mg/kg[47] Drug Development and IND Applications - The company plans to submit IND applications for IMM01 in atherosclerosis and IMM0306 in autoimmune diseases, including SLE, LN, and NMOSD, within the year[8] - The company has developed a new candidate drug, IMM72 (ACTRIIA fusion protein), currently in the preclinical stage for weight loss while maintaining muscle mass and treating PAH, with plans to submit a pre-IND application within the year[8] - The company has further developed a bispecific molecule, IMM7211b, for treating osteoporosis and increasing muscle mass, currently in the preclinical development stage[8] - IMM01 (IMM01) is in IND preparation for the treatment of atherosclerosis[20] - IMM72 (ACTRIIA fusion protein) showed preliminary efficacy in increasing skeletal muscle in PAH mouse models[20] - IMM7211b (ACTRIIA×undisclosed target bispecific molecule) completed candidate screening and proof-of-concept studies[20] - IMM01 + azacitidine received approval for Phase III clinical trials in China for MDS, AML, and CMML[24] - IMM0306 monotherapy entered Phase II trials in 2023 for R/R FL and MZL[24] - IMC-002 (IMM0306) submitted IND application to NMPA in March 2024 for SLE, LN, MN, NMOSD, and MG[24] - IMM67 (recombinant human hyaluronidase) is expected to be registered with NMPA by the end of 2024[24] - IMM01 received orphan drug designation from the FDA for CMML treatment in combination with azacitidine in November 2023[26] - IMM01 combined with tislelizumab completed Phase II recruitment for R/R cHL with 33 patients enrolled, and Phase III trial approval was obtained in April 2024[29] - IMM0306 completed Phase I patient recruitment and initiated Phase II trials in Q2 2023[35] - IMM01 is being explored for potential use in treating atherosclerosis through blocking the CD47/SIRPα signaling pathway[32] - IMM2510 combined with IMM27M received IND approval for Phase I clinical trials in advanced solid tumors, with trials expected to begin in Q2 2024[43] - IMM2510 combined with chemotherapy received IND approval for Phase II clinical trials as first-line treatment for NSCLC or TNBC[43] - IMM0306 is being developed for autoimmune diseases, with an IND application submitted to the NMPA in March 2024[38] - IMM2510 Phase I dose escalation study completed with 33 patients, showing no dose-limiting toxicities and an RP2D of 20 mg/kg every two weeks[40] - IMM2510 Phase II clinical trial for R/R STS in China began patient dosing in November 2023[42] - IMM27M Phase I dose escalation study completed with no dose-limiting toxicities observed up to 7.5 mg/kg, and an RP2D of 5 mg/kg every three weeks[44] - IMM2902 (CD47 × HER2) is in dose escalation at 4.0 mg/kg in China, with the dose escalation expected to be completed by the end of 2024[48] - IMM47 (CD24 monoclonal antibody) received IND approvals from both the Chinese NMPA and the US FDA for the treatment of advanced solid tumors and R/R B-NHL in 2023[49] - IMM72 (ACTRIIA fusion protein) showed preliminary efficacy in increasing skeletal muscle in a PAH mouse model, with IND expected to be filed in 2024[50] - IMM7211b (ACTRIIA × undisclosed target) completed candidate drug screening and proof-of-concept studies, with cell line development ongoing[51] - IMM67 (recombinant human hyaluronidase) completed development as a pharmaceutical excipient in small-scale bioreactors, with pilot-scale production expected to be completed by the end of 2024[52] Financial Performance - R&D expenses increased by 5.3% from RMB 277.3 million in 2022 to RMB 291.9 million in 2023, driven by clinical trial expenses and salary-related costs[21] - Net loss for 2023 decreased to RMB 379.5 million from RMB 402.9 million in 2022, primarily due to reduced losses from financial liabilities[21] - Adjusted net loss for 2023 increased to RMB 281.8 million from RMB 225.8 million in 2022, reflecting continued investment in R&D[22] - The company's total revenue for 2023 was RMB 386 thousand, a decrease from RMB 538 thousand in 2022, primarily from the sale of cell lines and testing services[54][55] - 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 subsidies and a RMB 1.3 million increase in bank interest income[56] - Other gains and losses turned from a loss of RMB 29.4 million in 2022 to a gain of RMB 1.8 million in 2023, primarily due to a RMB 55.5 million decrease in losses from financial liabilities and a RMB 26.0 million decrease in foreign exchange gains[57] - Administrative expenses decreased by 13.3% from RMB 92.8 million in 2022 to RMB 80.4 million in 2023, primarily due to a reduction in share-based payments[61] - Listing expenses amounted to RMB 26.0 million during the reporting period[62] - Financial costs increased from RMB 0.8 million in 2022 to RMB 1.5 million in 2023, mainly due to higher interest on borrowings[63] - The company reported a net loss of RMB 379.5 million in 2023, down from RMB 402.9 million in 2022[64] - Adjusted net loss for 2023 was RMB 281.8 million, compared to RMB 225.8 million in 2022, after excluding certain non-cash items and listing expenses[66] - Cash and cash equivalents decreased to RMB 608.6 million as of December 31, 2023, from RMB 635.2 million in 2022, primarily due to cash outflows for daily business operations and R&D activities[68] - Current assets totaled RMB 686.7 million as of December 31, 2023, including RMB 307.0 million in cash and cash equivalents, RMB 42.5 million in time deposits, and RMB 259.1 million in financial assets at fair value[68] - Net cash used in operating activities increased to RMB 367.6 million in 2023, up from RMB 238.7 million in 2022, driven by business expansion and clinical trial progress[68] - Net cash used in investing activities rose to RMB 294.8 million in 2023, compared to a net cash inflow of RMB 49,000 in 2022, mainly due to the purchase of financial assets at fair value[68] - Net cash from financing activities increased to RMB 331.0 million in 2023, up from RMB 179.4 million in 2022, primarily due to proceeds from global offerings and unsecured bank borrowings[68] - The company's asset-liability ratio increased to 14.4% as of December 31, 2023, from 7.2% in 2022, mainly due to an increase in bank borrowings of RMB 60.0 million[70] - The company holds unsecured bank borrowings of RMB 60.0 million as of December 31, 2023, with interest rates ranging from 3.0% to 3.4%[71] - The company invested in four redeemable structured note financial products with expected annualized returns of 1.5% to 4.5%, totaling RMB 123.0 million, RMB 45.8 million, RMB 45.2 million, and RMB 45.1 million as of December 31, 2023[73] - Total employee compensation costs decreased to RMB 155.7 million in 2023, down from RMB 173.1 million in 2022, primarily due to a reduction in non-cash share-based payments[75] Corporate Governance and Leadership - The company's board consists of 8 directors, including 2 executive directors, 3 non-executive directors, and 3 independent non-executive directors[76] - Dr. Tian Wenzhi, the founder and CEO, has over 30 years of experience in the biomedical industry and holds 28 authorized patents[76] - Dr. Tian Wenzhi was appointed as an executive director on June 14, 2022, and oversees the company's strategic planning, business management, and R&D activities[76] - Li Song, appointed as an executive director on June 14, 2022, leads the company's preclinical R&D efforts and has over 10 years of experience in the biopharmaceutical industry[77] - Song Ziyi, the CFO and executive director, will resign on March 2, 2024, to focus on other business endeavors[77] - Dr. Xu Cong, a non-executive director since June 14, 2022, provides advice on the company's business plans, major decisions, and investment activities[78] - Dr. Xu Cong has approximately 10 years of experience in the biomedical and finance industries and serves as a director for multiple biotech companies[78] - The company's R&D efforts are driven by a strong focus on innovation, with Dr. Tian Wenzhi playing a key role in research-oriented development[76] - The company has established subsidiaries, including Yiming Tanke, Yiming Angke Shanghai, Macroimmune, ImmuneOnco Hong Kong, and Yiming Kaier, under Dr. Tian Wenzhi's leadership[76] - The company's leadership team combines extensive industry experience with a strong academic background, contributing to its strategic growth and innovation[76][77][78] - The company's board of supervisors consists of three members, with Mr. Gu Jiefeng serving as the chairman since March 1, 2016[84] - Mr. Gu Jiefeng has over 10 years of experience in investment and financing, and currently serves as the rotating general manager of Shanghai Zhangke Herun Venture Capital Co., Ltd since August 2021[84] - Ms. Tian Miao, aged 32, was appointed as a supervisor in July 2017 and currently serves as the supervisor of the company's subsidiary, Yiming Tanke[85] - Mr. Zhao Zimeng, aged 33, was appointed as the employee representative supervisor in January 2022 and currently serves as the supervisor of the company's subsidiary, Yiming Angke Shanghai[85] - Mr. Zhang Ruliang, aged 40, was appointed as the company's senior vice president in January 2023, responsible for CMC and global clinical registration[86] - Dr. Lu Qiying, aged 50, was appointed as the company's chief medical officer and senior vice president in March 2022, responsible for clinical strategy and direct clinical development[87] - Dr. Xiong Zikai, aged 44, was appointed as the company's senior vice president in March 2022, responsible for business development[88] - Dr. Xiong Zikai has over 14 years of experience in business development and other key functions in the biomedical and pharmaceutical industries[88] - The company did not recommend paying a final dividend for the fiscal year ending December 31, 2023 (2022: none)[94] - The company has no distributable reserves as of December 31, 2023[95] - The company faces intense competition in drug development and commercialization, which could delay or hinder its progress[97] - The company relies heavily on the success of its clinical-stage and preclinical-stage drug candidates, and failure in development or regulatory approval could severely impact its business[97] - Delays in recruiting clinical trial participants could adversely affect the company's clinical development activities[97] - Regulatory approval processes for drug candidates are lengthy, costly, and unpredictable, which could harm the company's business if approvals are delayed or denied[98] - The company may seek accelerated approval pathways for its drug candidates, but failure to utilize these could result in additional trials and increased costs[98] - Non-compliance with regulatory standards or adverse actions by regulatory bodies could negatively impact the company's reputation and business[98] - The company's business is focused on developing tumor immunotherapy, with no significant changes in its primary business nature since its listing[93] - The company's financial performance and operational metrics for the fiscal year ending December 31, 2023, are detailed in the "Management Discussion and Analysis" section of the annual report[96] - Top five suppliers accounted for 38.9% of the company's total procurement in 2023, up from 30.
宜明昂科-B(01541) - 2023 - 年度财报