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Opthea Reports Half Year Results and Business Updates
OPTOpthea(OPT) Newsfilter·2025-02-28 12:00

Core Viewpoint - Opthea Limited is progressing towards delivering innovative therapies for wet age-related macular degeneration (wet AMD), with significant advancements expected in its clinical trials and financial management [2][3]. Financial Results and Highlights - For the six months ended December 31, 2024, Opthea reported a net loss of US131.9million,anincreasefromUS131.9 million, an increase from US101.7 million in the same period of 2023, primarily due to fair value losses on investor options and interest expenses [5][23]. - Cash and cash equivalents stood at US131.9millionasofDecember31,2024,withacashrunwayexpectedtoextendthroughtheanticipatedtoplinedatareadoutsofthePhase3trialsCOASTandShORe[2][5].−NetcashflowsusedinoperatingactivitieswereUS131.9 million as of December 31, 2024, with a cash runway expected to extend through the anticipated topline data readouts of the Phase 3 trials COAST and ShORe [2][5]. - Net cash flows used in operating activities were US72.6 million, compared to US69.4millionintheprioryear[5].ClinicalDevelopmentProgram−OptheaisconductingtwopivotalPhase3clinicaltrials,COASTandShORe,aimedatevaluatingtheefficacyofsoziniberceptincombinationwithstandardanti−VEGF−AtherapiesforwetAMD[9][14].−ToplineresultsfromtheCOASTtrialareexpectedinearlyQ2CY2025,whileresultsfromtheShORetrialareanticipatedinmid−CY2025[6][9].−SozinibercepthasreceivedFastTrackDesignationfromtheUSFDA,indicatingitspotentialtoaddresssignificantunmetmedicalneedsinwetAMD[9].ProductOverview−Soziniberceptisafirst−in−classVEGF−C/D′trap′inhibitordesignedtoimprovevisioninwetAMDpatients,potentiallybecomingthefirsttherapyinnearly20yearstodemonstratesuperiorvisualoutcomes[8][14].−ThedrugtargetstheinhibitionofVEGF−CandVEGF−D,whichareknowntocontributetoretinaldiseases,therebypreventingbloodvesselgrowthandvascularleakage[8].CorporateHighlights−RecentcorporatedevelopmentsincludetheappointmentofnewexecutivesandthecompletionofasignificantcapitalraisinginitiativetotalingapproximatelyA69.4 million in the prior year [5]. Clinical Development Program - Opthea is conducting two pivotal Phase 3 clinical trials, COAST and ShORe, aimed at evaluating the efficacy of sozinibercept in combination with standard anti-VEGF-A therapies for wet AMD [9][14]. - Topline results from the COAST trial are expected in early Q2 CY2025, while results from the ShORe trial are anticipated in mid-CY2025 [6][9]. - Sozinibercept has received Fast Track Designation from the US FDA, indicating its potential to address significant unmet medical needs in wet AMD [9]. Product Overview - Sozinibercept is a first-in-class VEGF-C/D 'trap' inhibitor designed to improve vision in wet AMD patients, potentially becoming the first therapy in nearly 20 years to demonstrate superior visual outcomes [8][14]. - The drug targets the inhibition of VEGF-C and VEGF-D, which are known to contribute to retinal diseases, thereby preventing blood vessel growth and vascular leakage [8]. Corporate Highlights - Recent corporate developments include the appointment of new executives and the completion of a significant capital raising initiative totaling approximately A227.3 million (US$150 million) [6][9]. - Opthea joined the S&P/ASX 300 Index in September 2024, reflecting its growing market presence [6].