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Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights
TNXPTonix Pharmaceuticals (TNXP) Newsfilter·2025-03-18 20:30

Core Insights - Tonix Pharmaceuticals is preparing for the potential launch of TNX-102 SL for fibromyalgia management, with a PDUFA goal date set for August 15, 2025, marking the first new drug for this condition in over 15 years [1][2][5] - The company reported a cash position of approximately 98.8millionasofDecember31,2024,whichisexpectedtofundoperationsthroughtheanticipatedlaunchofTNX−102SL[1][20]−PositivetoplineresultsfromaPhase1studyofTNX−1500,ananti−CD40Lmonoclonalantibody,wereannounced,supportingitsadvancementtoaPhase2trial[1][13][8]FinancialHighlights−Forthefourthquarterof2024,netproductrevenuewasapproximately98.8 million as of December 31, 2024, which is expected to fund operations through the anticipated launch of TNX-102 SL [1][20] - Positive topline results from a Phase 1 study of TNX-1500, an anti-CD40L monoclonal antibody, were announced, supporting its advancement to a Phase 2 trial [1][13][8] Financial Highlights - For the fourth quarter of 2024, net product revenue was approximately 2.6 million, a decrease from 3.8millioninthesameperiodin2023[22]−Researchanddevelopmentexpensesforthefourthquarterof2024wereapproximately3.8 million in the same period in 2023 [22] - Research and development expenses for the fourth quarter of 2024 were approximately 8.3 million, down from 17.1millioninthepreviousyear,attributedtofewerclinicaltrials[23]−Thenetlossavailabletocommonstockholdersforthefourthquarterof2024was17.1 million in the previous year, attributed to fewer clinical trials [23] - The net loss available to common stockholders for the fourth quarter of 2024 was 22.1 million, compared to a net loss of 27.3millioninthesamequarterof2023[25]ProductDevelopmentandPipeline−TNX−102SLisasublingualformulationofcyclobenzaprinedesignedforthemanagementoffibromyalgia,showingstatisticallysignificantpainreductioninPhase3studies[5][9]−TNX−1500isbeingdevelopedforthepreventionofkidneytransplantrejectionandtreatmentofautoimmunediseases,withafavorablesafetyprofiledemonstratedinPhase1trials[8][13]−TNX−801,apotentialvaccineformpoxandsmallpox,hasshownpromisingresultsinnon−humanprimatesandisadvancingtowardsclinicaltesting[11][30]CorporateDevelopments−Thecompanyisnowdebt−freefollowingtherepaymentofamortgageinFebruary2025[19]−Tonixhasexpandeditsleadershipteamwithkeyappointmentstoenhanceitscommercialandtechnicalcapabilities[18]−ThecompanyreceivedacontractfromtheU.S.DepartmentofDefenseforthedevelopmentofbroad−spectrumantiviraldrugs,withpotentialfundingofupto27.3 million in the same quarter of 2023 [25] Product Development and Pipeline - TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for the management of fibromyalgia, showing statistically significant pain reduction in Phase 3 studies [5][9] - TNX-1500 is being developed for the prevention of kidney transplant rejection and treatment of autoimmune diseases, with a favorable safety profile demonstrated in Phase 1 trials [8][13] - TNX-801, a potential vaccine for mpox and smallpox, has shown promising results in non-human primates and is advancing towards clinical testing [11][30] Corporate Developments - The company is now debt-free following the repayment of a mortgage in February 2025 [19] - Tonix has expanded its leadership team with key appointments to enhance its commercial and technical capabilities [18] - The company received a contract from the U.S. Department of Defense for the development of broad-spectrum antiviral drugs, with potential funding of up to 34 million over five years [1][30]