Investment Rating - The report assigns a "Buy" rating for the company [6]. Core Insights - The company is developing the world's first SIRPα-Fc fusion protein targeting CD47, which is expected to achieve breakthroughs in cancer treatment [3][11]. - The core product, IMM01, has shown promising results in clinical trials, with a peak sales potential estimated at 1.05 billion yuan [2][6]. - The company has multiple clinical-stage assets, including dual-specific antibodies, with a long-term sales peak potential of 3.17 billion yuan [3]. Company Overview - The company, established in June 2015, focuses on developing cancer immunotherapy and has received 29 IND approvals from NMPA and FDA, with 8 products currently in clinical trials [11][14]. - The major revenue source is from licensing fees, with a significant R&D expenditure of 1.19 billion yuan in the first half of 2024 [20]. Industry Situation - Cancer immunotherapy has emerged as a revolutionary treatment, with a global market size reaching 50.2 billion USD in 2022 [27]. - The report highlights the limitations of existing therapies, particularly those targeting T-cell immune checkpoints, and emphasizes the potential of innate immune cell-targeted therapies [23][26].

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 $15 million and potential milestone payments up to $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] -

Investment Rating - The report suggests a positive outlook on the company, recommending active attention due to its strong clinical data and rich pipeline reserves [1]. Core Insights - The company is one of the few biotechnology firms globally capable of systematically utilizing both innate and adaptive immune systems [1]. - The core product, IMM01, has shown excellent clinical data and possesses a unique mechanism of action, indicating a broad market potential [1]. - The company has reduced R&D expenses in the first half of 2024, primarily due to decreased clinical trial costs and reduced share-based payments [1]. Summary by Sections Financial Performance - For the six months ending June 30, 2024, the company reported a narrowed loss attributable to shareholders of 166 million yuan, compared to a loss of 171 million yuan in the same period last year; total revenue was 77,000 yuan, a decrease of 10.47% year-on-year; net asset value per share was 1.6042 yuan [1]. Product Development - IMM01 is the first clinical-stage SIRP α-Fc fusion protein in China, designed to activate macrophages through a dual mechanism while avoiding binding to human red blood cells [1]. - The product has received orphan drug designation from the FDA for use in combination with azacitidine for treating CMML, with an overall response rate (ORR) of 72.7% in 22 evaluable patients [1]. - In a Phase II clinical trial for high-risk myelodysplastic syndromes, the overall response rate was 64.7% among 51 evaluable patients, with improved efficacy observed with longer treatment durations [1].

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].

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]