Financial Performance - Laekna, Inc. reported a revenue of 10millionforthefirsthalfof2024,representinga251 million for the first half of 2024, a reduction from a 1.5millionlossinthesameperiodlastyear[5].−ThetotalcomprehensivelossforthesixmonthsendedJune30,2024,wasRMB138.5million,adecreasefromRMB285.8millioninthesameperiodof2023[19].−BasicanddilutedlosspershareforthesixmonthsendedJune30,2024,wasRMB0.40,significantlyimprovedfromRMB2.63inthesameperiodof2023[104].−ThelossfromoperationsforthesixmonthsendedJune30,2024,wasRMB142.4million,aslightimprovementfromalossofRMB145.0millioninthesameperiodof2023[104].ResearchandDevelopment−Thecompanyhasallocated2 million for research and development of new therapies in the next fiscal year[5]. - R&D expenses increased by 23.3% to RMB 126.1 million for the six months ended June 30, 2024, primarily due to clinical trial milestones related to the Phase III trial[19]. - The company achieved significant progress in clinical and preclinical development of candidate drug assets as of June 30, 2024[11]. - The company has initiated seven clinical trials targeting unmet medical needs in obesity and cancer as of June 30, 2024[21]. - The company is actively pursuing strategic partnerships to accelerate the development and commercialization of its drug candidates[15]. Product Development and Clinical Trials - The company has initiated clinical trials for its new drug candidate Afuresertib, targeting a market with an estimated value of 5billion[4].−Laeknahasreceivedregulatoryapprovalfortwonewdrugs,whichareexpectedtolaunchinQ42024[2].−LAE102,amonoclonalantibodytargetingActRIIAforobesity,receivedINDapprovalfromCDEandFDAinQ22024,withPhaseIclinicaltrialsstartinginJune2024[12].−ThePhaseItrialforLAE102aimstocompletethesingleascendingdoseportionbyQ42024,focusingonsafety,tolerability,andpharmacokinetics[12].−ThePhaseIIIclinicaltrialAFFIRM−205forLAE002(afuresertib)combinedwithfulvestrantinHR+/HER2−breastcancerpatientswasinitiatedinMay2024,aheadofschedule[13].−ThecompanyplanstopresentclinicaldatafromthePhaseIstudyofLAE002attheESMOconferenceinSeptember2024[13].MarketExpansionandStrategy−LaeknaisplanningtoexpanditsmarketpresenceinEurope,aimingfora1550,000, divided into 5,000,000,000 ordinary shares with a par value of $0.00001 each[139]. - The total number of stock options granted to employees, directors, and consultants is 33,618,520, with 20% expected to vest after 12 months from the grant date[136]. Governance and Compliance - The company has adopted the corporate governance code as its own, ensuring compliance with all relevant provisions during the reporting period, except for the deviation regarding the separation of the roles of Chairman and CEO[97]. - The audit committee, consisting of two independent non-executive directors and one non-executive director, has reviewed the interim financial report and discussed internal controls and financial reporting matters[99]. - The independent auditor, KPMG, conducted a review of the interim financial report and found no issues that would lead to a belief that the report was not prepared in accordance with the relevant standards[103].
