Drug Development Progress - Laekna, Inc. achieved significant progress in clinical and preclinical drug development, with key milestones reached by December 31, 2023[2]. - The company advanced the clinical trial of Afuresertib combined with Fulvestrant for HR+/HER2- breast cancer, with promising efficacy and safety data presented at the 2023 SABCS[3]. - A Phase II clinical trial for Afuresertib combined with LAE001 and Prednisone in mCRPC patients was completed in March 2023, showing potential for good therapeutic outcomes[4]. - The company plans to initiate a Phase III trial for Afuresertib combined with Paclitaxel in PROC patients, with data lock scheduled for December 2023[4]. - The company advanced seven PCC candidates in its independent R&D platform as of December 31, 2023[5]. - The company has initiated six clinical trials targeting Afuresertib (LAE002), LAE001, and LAE005 to address unmet medical needs in oncology[44]. - The company has a robust pipeline with a total of 14 internally discovered candidates and has initiated six clinical trials since its establishment in 2016[45]. - Afuresertib is one of only two AKT inhibitors globally in key clinical development stages, demonstrating superior efficacy and safety compared to other AKT inhibitors[45]. - The company plans to submit IND applications for LAE102 for obesity indications to CDE and FDA in Q1 2024[46]. - LAE102 has received IND approval from the FDA in May 2023, with further submissions planned for additional indications[46]. - The company is actively seeking strategic partners to accelerate the development and commercialization of LAE102 for significant unmet medical needs beyond oncology[46]. - The company is developing innovative candidate drugs, including small molecule drugs and bispecific antibodies, to address unmet medical needs in obesity and metabolic diseases[84]. - The company aims to introduce one candidate drug into clinical stages each year as part of its drug development strategy[84]. Financial Performance - The company reported a net loss of RMB 368.8 million for the year, down from RMB 781.6 million in 2022[8]. - Total comprehensive loss for the year was RMB 458.7 million, compared to RMB 902.2 million in 2022[8]. - R&D expenses decreased by 26.4% from RMB 313.4 million in 2022 to RMB 230.5 million in 2023[6]. - Administrative expenses reduced by 5.4% from RMB 80.2 million in 2022 to RMB 75.9 million in 2023[7]. - The fair value change of financial instruments issued to investors was RMB 71.2 million in 2023, down from RMB 387.1 million in 2022[6]. - Total assets decreased from RMB 1,145,586 thousand in 2022 to RMB 812,541 thousand in 2023, a decline of approximately 29%[9]. - Current liabilities increased significantly from RMB 97,509 thousand in 2022 to RMB 119,762 thousand in 2023, representing a growth of about 23%[9]. - Cash and cash equivalents increased from RMB 323,070 thousand at the beginning of the year to RMB 440,815 thousand at year-end, a net increase of RMB 117,210 thousand[12]. - The company reported a net asset value of RMB 803,972 thousand in 2023, recovering from a net loss of RMB (1,905,086) thousand in 2022[9]. - The company’s total liabilities decreased from RMB 2,287,441 thousand in 2022 to RMB 8,569 thousand in 2023, a significant reduction of about 99.6%[9]. - The company’s total equity improved to RMB 803,972 thousand in 2023 from a negative equity position in 2022, reflecting a positive turnaround in financial health[9]. - The company reported a revenue of HKD 1.2 billion for the fiscal year ending December 31, 2023, representing a year-over-year increase of 25%[94]. - The company expects revenue growth of 20% for the next fiscal year, projecting a target of HKD 1.44 billion[94]. - Other income increased by RMB 11.9 million or 247.9% to RMB 16.7 million in 2023, primarily due to increased interest income from bank deposits[65]. - The company reported a significant reduction in operational costs by 10% due to improved efficiency measures implemented in Q4 2023[94]. Clinical Trial Results - The confirmed objective response rate (ORR) for the treatment is 30%, with a disease control rate of 80% and a median progression-free survival (PFS) of 7.3 months[54]. - Among 11 PIK3CA/AKT1/PTEN positive subjects, the confirmed ORR is 45.4%, indicating a strong efficacy in this subgroup[54]. - The confirmed ORR for 17 Chinese patients is 29.4%, with a disease control rate of 82.4%[54]. - The median rPFS for mCRPC patients treated with afuresertib in a Phase II trial is 7.9 months, significantly improved compared to the historical median of 2 to 4 months[57]. - In the Phase II PROFECTA-II trial, afuresertib combined with paclitaxel showed a median PFS of 5.4 months in the biomarker-positive subgroup, compared to 2.9 months for paclitaxel alone[59]. - The company has initiated a Phase III pivotal trial for afuresertib combined with fulvestrant in HR+/HER2- breast cancer patients[55]. - The ongoing I/II study with XinDa Biopharmaceuticals aims to explore a combination therapy with PD-1/PD-L1 inhibitors for solid tumor patients previously treated with chemotherapy[60]. - The safety profile of afuresertib in combination therapies remains manageable and consistent with known safety characteristics[59]. - The company has observed a higher response rate in cervical and endometrial cancer patients after receiving prior PD-1 therapy and/or chemotherapy[60]. Corporate Governance and Compliance - The company has adhered to corporate governance principles and has confirmed compliance with all relevant rules since its listing date[85]. - The board will continue to review the effectiveness of the corporate governance structure to assess the need for separating the roles of Chairman and CEO[86]. - The company has established an Audit Committee in accordance with Listing Rule 3.21, consisting of two independent non-executive directors and one non-executive director[89]. - The Audit Committee has reviewed the accounting principles and policies adopted by the group and discussed internal controls and financial reporting matters, including the consolidated financial statements for the year ending December 31, 2023[89]. - The auditors will verify the financial figures in the preliminary announcement for the year ending December 31, 2023, but will not provide any assurance or opinion on the preliminary announcement[90]. - There have been no significant events occurring after the reporting period, except for changes in independent non-executive directors and company secretary roles effective from January 15, 2024, and February 2, 2024, respectively[91]. - The company has not declared a final dividend for the reporting period[91]. Strategic Partnerships and Market Expansion - The company is actively exploring combination therapy opportunities with existing approved drugs and traditional therapies, particularly for HR+/HER2- breast cancer patients, which represents a significant unmet medical need and market potential[83]. - The company has initiated a strategic partnership with Novartis to enhance its pipeline of PD-1 inhibitors, potentially increasing market competitiveness[94]. - A recent acquisition of a biotech firm is expected to enhance the company's capabilities in mCRPC therapies, with an estimated contribution of HKD 200 million to revenue[95]. - The company is expanding its market presence in Southeast Asia, aiming for a 15% market share by 2025[95].
来凯医药-B(02105) - 2023 - 年度业绩