来凯医药(02105) - 2025 - 中期业绩

Business Summary The company achieved significant clinical progress with its core products and anticipates key milestones in the latter half of 2025 Clinical Trial Progress The company achieved significant clinical progress during the reporting period, advancing core products LAE102 (obesity) and LAE002 (afuresertib) in various clinical trials, alongside preclinical candidates - The self-developed obesity drug LAE102 (an ActRIIA-targeting monoclonal antibody) successfully completed its Phase I SAD study in China, demonstrating good tolerability, no serious adverse events, and sustained pathway blockade, laying the foundation for further development[4][5] - The company entered a clinical collaboration with Eli Lilly to accelerate LAE102's global development, with Lilly responsible for and bearing the costs of the US Phase I clinical trial, where the first subject was dosed in May 2025[7] - The Phase III clinical trial AFFIRM–205 of LAE002 (afuresertib) combined with fulvestrant for HR+/HER2- breast cancer is ongoing in China, with patient enrollment planned for completion by Q4 2025 and an NDA submission targeted for H1 2026[11] - The company has established a comprehensive ActRII product portfolio, including LAE103 (ActRIIB selective antibody) and LAE123 (ActRIIA/IIB dual antagonist antibody) in addition to LAE102, actively advancing their clinical research for muscle and other diseases[8][10] LAE102 for Obesity, Phase I - In the China Phase I SAD study, LAE102 demonstrated good tolerability after intravenous (IV) and subcutaneous (SC) administration, with no serious adverse events or treatment-discontinuing adverse events reported[5] - The Phase I multiple ascending dose (MAD) study was initiated in China in March 2025, and the first subject was dosed in the US Phase I clinical trial in collaboration with Eli Lilly in May 2025[6][7] LAE002 (afuresertib) + Fulvestrant for HR+/HER2– Breast Cancer, Phase III - The AFFIRM–205 Phase III clinical trial was initiated in China in May 2024, with ongoing recruitment targeting completion by Q4 2025[11] LAE002 (afuresertib) + LAE001/Prednisone for mCRPC, Phase II - The international multi-center Phase II clinical trial completed in 2024 showed a median radiographic progression-free survival (rPFS) of 8.1 months, a significant improvement over the 2-4 months for standard therapy, with the combination therapy being well-tolerated[12] - The company has received US FDA approval for the Phase III clinical trial protocol for this indication and plans to seek strategic partners to accelerate development and commercialization[13] Preclinical Candidate Drugs (PCC) - The IND application for LAE103 was submitted to the US FDA in June 2025, with a Phase I clinical study planned for initiation in H2 2025; LAE123 is projected to advance to Phase I clinical trials in 2026[14] - In oncology, the USP1 inhibitor LAE120 received FDA approval for clinical trials in February 2025, and the WRN inhibitor LAE122 completed PCC confirmation in March 2025[14] Expected Milestones in H2 2025 The company anticipates key milestones in H2 2025, including announcing LAE102 Phase I results, completing AFFIRM–205 patient enrollment, and initiating LAE103 Phase I clinical studies - LAE102: Expected to announce topline results from the China Phase I MAD study and US Phase I clinical trial[15] - AFFIRM–205: Expected to complete subject enrollment for the China Phase III trial[16] - Other ActRII-targeted drugs: Expected to initiate LAE103 Phase I clinical study[17] Financial Summary and Statements This section details the company's financial performance, position, and cash flows for the reporting period, highlighting key changes in expenses and liquidity Financial Summary For the six months ended June 30, 2025, R&D expenses decreased by 16.6% to RMB 105.2 million due to prior-period milestone payments, while administrative expenses increased by 39.1% to RMB 42.3 million, narrowing the period's loss to RMB 129.6 million Financial Summary (For the six months ended June 30) | Metric | 2025 (RMB '000) | 2024 (RMB '000) | Y-o-Y Change | | :--- | :--- | :--- | :--- | | R&D Expenses | 105,192 | 126,148 | -16.6% | | Administrative Expenses | 42,321 | 30,380 | +39.1% | | Loss for the Period | 129,637 | 143,706 | -9.8% | | Total Comprehensive Loss for the Period | 133,399 | 138,548 | -3.7% | - The decrease in R&D expenses was primarily due to a RMB 17.8 million milestone payment related to the AFFIRM-205 Phase III clinical trial in H1 2024, with no such expenses in the current reporting period[19] - The increase in administrative expenses was mainly attributable to higher equity-settled share-based payment expenses[20] Consolidated Statement of Profit or Loss and Other Comprehensive Income During the period, other income grew 40.7% to RMB 19.91 million, operating loss narrowed to RMB 127.6 million from RMB 142.4 million, and net loss was RMB 129.6 million, with basic and diluted loss per share at RMB 0.35 Key Items from Consolidated Statement of Profit or Loss (For the six months ended June 30) | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Other Income | 19,908 | 14,149 | | Administrative Expenses | (42,321) | (30,380) | | R&D Expenses | (105,192) | (126,148) | | Loss from Operations | (127,605) | (142,383) | | Loss Before Tax | (129,637) | (143,706) | | Loss for the Period | (129,637) | (143,706) | | Basic and Diluted Loss Per Share (RMB) | (0.35) | (0.40) | Consolidated Statement of Financial Position As of June 30, 2025, the company reported total assets of RMB 913.4 million, total liabilities of RMB 200.6 million, and net assets of RMB 712.9 million, with cash and cash equivalents increasing to RMB 676.6 million Key Items from Consolidated Statement of Financial Position | Item | As of June 30, 2025 (RMB '000) | As of Dec 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Assets | | | | Non-current Assets | 151,048 | 146,636 | | Current Assets | 762,362 | 813,401 | | Of which: Cash and Cash Equivalents | 676,562 | 636,422 | | Liabilities and Equity | | | | Current Liabilities | 194,705 | 148,473 | | Non-current Liabilities | 5,849 | 6,772 | | Net Assets | 712,856 | 804,792 | | Total Equity | 712,856 | 804,792 | Condensed Consolidated Statement of Cash Flows Net cash outflow from operating activities significantly decreased to RMB 74.15 million, while investing activities generated RMB 105.9 million net cash inflow, and financing activities generated RMB 10.84 million, increasing period-end cash and cash equivalents to RMB 674.5 million Condensed Consolidated Statement of Cash Flows (For the six months ended June 30) | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | (74,149) | (143,382) | | Net Cash From Investing Activities | 105,926 | 101,835 | | Net Cash From Financing Activities | 10,841 | 5,575 | | Net Increase/(Decrease) in Cash and Cash Equivalents | 42,618 | (35,972) | | Cash and Cash Equivalents at Beginning of Period | 634,323 | 440,815 | | Cash and Cash Equivalents at End of Period | 674,542 | 407,331 | Management Discussion and Analysis This section provides an overview of the company's strategic pipeline, financial performance, liquidity, and future development plans, including the use of proceeds Overview and Pipeline Review The company is a science-driven clinical-stage biopharmaceutical firm focused on metabolic diseases, cancer, and liver fibrosis, actively advancing its ActRII product portfolio and AKT inhibitor afuresertib through clinical trials and strategic partnerships - The company has established a comprehensive ActRII product portfolio in the metabolic field, with LAE102 showing promise as a potential drug for muscle-preserving weight loss[51] - In oncology, the core product LAE002 (afuresertib) is one of only two AKT inhibitors globally in late-stage clinical development for breast and prostate cancer, with a Phase III pivotal study initiated in China[52] - The Phase II trial of LAE002 combined with LAE001 for mCRPC showed a median rPFS of 8.1 months, significantly outperforming standard therapy[68] - In the Phase I trial of LAE002 combined with LAE005 and chemotherapy for triple-negative breast cancer (TNBC), the objective response rate (ORR) was 35.7%, and the disease control rate (DCR) was 64.3%[74] Financial Review During the period, other income increased by 41.1% due to government grants, administrative expenses rose by 39.1% from equity-settled share-based payments, and R&D expenses decreased by 16.6% primarily due to the absence of prior-period milestone payments R&D Expense Breakdown (For the six months ended June 30) | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Staff Costs | 41,806 | 34,580 | | R&D Research Expenses | 30,392 | 13,140 | | Clinical Development Expenses | 28,052 | 54,417 | | Clinical Trial Milestone Payments | – | 17,758 | | Other | 4,942 | 6,253 | | Total | 105,192 | 126,148 | Liquidity and Financial Resources As of June 30, 2025, the company held RMB 743.8 million in cash and bank balances, with current assets of RMB 762.4 million and current liabilities of RMB 194.7 million, resulting in a current ratio of 3.92 and a net cash position - As of June 30, 2025, cash and cash equivalents were RMB 676.6 million, a 6.3% increase from RMB 636.4 million at the end of 2024[81] - As of June 30, 2025, the current ratio was 3.92, compared to 5.48 as of December 31, 2024[85] - The company is in a net cash position, thus the debt-to-asset ratio is not applicable[86] Use of Net Proceeds The company detailed the use of net proceeds from its global offering and placing, with HKD 489.8 million utilized from the HKD 724.4 million global offering and HKD 51.6 million from the HKD 230.4 million November 2024 placing, primarily for LAE102 and ActRII drug R&D Use of Net Proceeds from Global Offering (As of June 30, 2025) | Intended Use | Allocated Amount (HKD Million) | Cumulative Utilized (HKD Million) | Unutilized Amount (HKD Million) | | :--- | :--- | :--- | :--- | | Core Product Clinical Development | 407.8 | 269.7 | 138.1 | | Other Pipeline Product R&D | 150.7 | 144.4 | 6.3 | | Enhance Production Capacity and Manufacturing Capabilities | 71.7 | 4.9 | 66.8 | | Business Development Activities | 55.1 | 26.7 | 28.4 | | Working Capital and Other | 39.1 | 39.1 | – | Use of Net Proceeds from Placing (As of June 30, 2025) | Intended Use | Allocated Amount (HKD Million) | Cumulative Utilized (HKD Million) | Unutilized Amount (HKD Million) | | :--- | :--- | :--- | :--- | | Accelerate LAE102 and ActRII Drug R&D | 230.4 | 51.6 | 178.7 | Future Developments The company plans to expand its metabolic and oncology portfolios, focusing on ActRII product development, aiming to advance one candidate to clinical stage annually, and seeking strategic collaborations to accelerate clinical development and commercialization - The company will continue to build and expand its ActRII product portfolio to maximize the development value of ActRII receptor targeting[98] - The goal is to advance one candidate drug into clinical stage annually and continuously explore the potential for combination therapies[99][100] - Following the collaboration with Eli Lilly, the company plans to establish strategic partnerships with more global leading pharmaceutical companies to accelerate asset clinical development and commercialization[101] Corporate Governance and Other Information This section outlines the company's adherence to corporate governance principles, the Audit Committee's review, and the Board's decision regarding interim dividends Corporate Governance and Compliance The company adopted and complied with the Corporate Governance Code, with the exception of the Chairman and CEO roles being held by the same individual, Dr. Lu Xiangyang, an arrangement the Board believes benefits strategic execution - The company complied with all relevant provisions of the Corporate Governance Code during the reporting period, with one deviation[102] - The deviation is that the roles of Chairman and Chief Executive Officer are not separated, both held by founder Dr. Lu Xiangyang, an arrangement the Board believes benefits strategic execution and communication efficiency[103] Audit Committee and Interim Results Review The company's Audit Committee, comprising independent non-executive and non-executive directors, reviewed the unaudited interim financial information, which was also independently reviewed by KPMG - The Audit Committee has reviewed the Group's accounting principles, policies, and unaudited interim financial information with management[108] - Independent auditor KPMG has reviewed the interim financial information in accordance with Hong Kong Standard on Review Engagements 2410[108] Dividends The Board did not recommend the payment of any interim dividend for the six months ended June 30, 2025 - The Board does not recommend the payment of any interim dividend for the six months ended June 30, 2025[110]