Investment Rating - The report on ImmuneOnco is classified as NOT RATED [2][10]. Core Insights - ImmuneOnco has successfully established an overseas licensing partnership with SynBioTx for its PD-L1xVEGF bispecific molecule IMM2510 and anti-CTLA-4 antibody IMM27M, which could yield up to US$50 million in near-term payments and over US$2.1 billion in potential milestone payments, along with royalties on global ex-China net sales [2]. - The Phase 1 clinical trial data for IMM2510 indicates promising antitumor activity, particularly in treating relapsed/refractory non-small cell lung cancer (R/R NSCLC) and thymus adeno-squamous carcinoma, with three patients achieving confirmed partial responses (PR) and seven achieving stable disease (SD) [3]. - Early pre-clinical studies of IMM27M show it has significantly stronger anti-tumor activity compared to ipilimumab, with two patients achieving confirmed PR in a Phase 1 trial for HR+ breast cancer [4]. - The company’s key asset, timdarpacept (IMM01), is advancing through clinical trials with favorable efficacy and safety profiles demonstrated in Phase 2 studies for higher risk myelodysplastic syndromes (MDS) and relapsed/refractory classical Hodgkin lymphoma (cHL) [5]. Financial Summary - For the fiscal year ending December 31, 2023, ImmuneOnco reported revenues of RMB 0 million, R&D expenses of RMB -292 million, administrative expenses of RMB -80 million, and a net loss of RMB -379 million [6]. - The year-end cash balance for 2023 was RMB 609 million [6]. Stock Data - The current market capitalization of ImmuneOnco is HK$ 4,714 million, with a current stock price of HK$ 12.60 [7]. - The stock has shown a 1-month performance increase of 17.7% and a 3-month increase of 6.1%, but a decline of 33.1% over the past 6 months [7].

Investment Rating - The report does not provide a specific investment rating for ImmuneOnco, indicating it is currently "NOT RATED" [5]. Core Insights - ImmuneOnco is a clinical-stage biotech company focusing on innate immune systems with a differentiated CD47-based portfolio and a rich pipeline of 8 drug candidates in clinical studies [2]. - The key product asset, Timdarpacept (IMM01), has shown promising results in Phase 2 studies and has moved to Phase 3 studies for various indications [2]. - The company has received approvals to conduct Phase 3 clinical trials for IMM01 in high-risk myelodysplastic syndromes (MDS) and classical Hodgkin lymphoma (cHL) [2]. Financial Summary - Revenue for FY21 was RMB 5 million, FY22 was RMB 1 million, and FY23 was RMB 0 million [3]. - R&D expenses increased from RMB 176 million in FY21 to RMB 292 million in FY23 [3]. - The net loss for FY23 was RMB 379 million, with a year-end cash balance of RMB 609 million [3]. Clinical Trial Results - In the Phase 2 trial of IMM01 combined with azacitidine for high-risk MDS, the overall response rate (ORR) was 64.7%, with a complete response (CR) rate of 33.3% among 51 evaluable patients [2]. - For patients who received initial treatment for 4 months or more, the ORR increased to 85.3%, with a CR rate of 50.0% [2]. - In the Phase 2 trial of IMM01 combined with tislelizumab for anti-PD-1 failed cHL, the ORR was 66.7%, with a CR rate of 24.2% among 33 evaluable patients [2]. Market Data - The market capitalization of ImmuneOnco is HK$ 5,403 million [4]. - The stock has shown a 1-month absolute performance of 4.3% and a 6-month performance decline of 52.2% [5].

Investment Rating - The report does not provide a specific investment rating for ImmuneOnco [1] Core Insights - ImmuneOnco is a clinical-stage biotechnology company focused on the innate immune system, with a differentiated product portfolio based on CD47, demonstrating good safety and efficacy [2] - The company has a robust pipeline with eight drug candidates in clinical research, including its lead asset Timdarpacept (IMM01), which has advanced to Phase 3 studies [2] - Recent promising results from the ASCO conference highlighted the efficacy of IMM01 in combination with azacitidine for high-risk myelodysplastic syndromes (MDS) and with tislelizumab for classical Hodgkin lymphoma (cHL) [2] Summary by Sections Company Overview - ImmuneOnco specializes in developing therapies targeting the innate immune system, particularly through CD47-based products [2] Clinical Trials and Results - IMM01 combined with azacitidine showed an overall response rate (ORR) of 64.7% in 51 evaluable MDS patients, with a complete response (CR) rate of 33.3% [2] - In patients receiving initial treatment for at least 4 months, the ORR increased to 85.3%, and for those treated for at least 6 months, it reached 89.7% [2] - The combination of IMM01 and tislelizumab in cHL patients demonstrated an ORR of 66.7% and a CR rate of 24.2% [2] Future Prospects - The promising efficacy and safety profile observed in Phase 2 trials support the initiation of Phase 3 studies for IMM01 [2] - The company has received approval from the CDE to conduct Phase 3 clinical trials for IMM01 in high-risk MDS, PD-1 failed cHL, and in combination with azacitidine for chronic myelomonocytic leukemia (CMML) [2] - A Biologics License Application (BLA) for IMM01 is expected to be submitted in 2026, potentially making it the first CD47-targeted therapy in China [2] Financial Overview - The company reported revenues of 5 million RMB in FY21, which decreased to 1 million RMB in FY22 and 0 in FY23 [3] - Research and development expenses increased from 176 million RMB in FY21 to 292 million RMB in FY23 [3] - The year-end cash balance decreased from 676 million RMB in FY21 to 609 million RMB in FY23 [3]

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.

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].

Financial Results - ImmuneOnco Biopharmaceuticals reported its interim financial results for the six months ended June 30, 2023, in accordance with International Accounting Standard 34[1] - The company will not publish an independent interim report or summary report for the six months ended June 30, 2023, as it is included in the prospectus dated August 24, 2023[2] Board of Directors - The board of directors consists of three executive directors, three non-executive directors, and three independent non-executive directors[2]