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Marker Therapeutics(MRKR) - 2024 Q3 - Quarterly Report

Revenue Generation - The company did not generate any revenue during the three months ended September 30, 2024 and 2023 from the sales or licensing of its product candidates [110]. - The company recognized 0.9millionand0.9 million and 0.2 million of revenue during the three months ended September 30, 2024 and 2023, respectively, associated with a 13.1milliongrantfromtheCancerPreventionandResearchInstituteofTexas(CPRIT)[111].Thecompanyrecognized13.1 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) [111]. - The company recognized 0.02 million of revenue during the three months ended September 30, 2024 and 2023, respectively, associated with a 2.0milliongrantfromtheFDAsOrphanProductsGrantprogram[112].Thecompanyrecognized2.0 million grant from the FDA's Orphan Products Grant program [112]. - The company recognized 0.3 million of revenue during the three months ended September 30, 2024, associated with a 2.0milliongrantfromtheNationalInstitutesofHealthSBIRprogram,whilenorevenuewasrecognizedinthesameperiodof2023[113].GrantincomeforthethreemonthsendedSeptember30,2024,was2.0 million grant from the National Institutes of Health SBIR program, while no revenue was recognized in the same period of 2023 [113]. - Grant income for the three months ended September 30, 2024, was 1,926,000, a 647% increase from 258,000inthesameperiodof2023[114].TotalrevenuesforthethreemonthsendedSeptember30,2024,were258,000 in the same period of 2023 [114]. - Total revenues for the three months ended September 30, 2024, were 1,926,000, reflecting a 647% increase compared to 258,000intheprioryear[114].GrantincomefortheninemonthsendedSeptember30,2024,was258,000 in the prior year [114]. - Grant income for the nine months ended September 30, 2024, was 4,339,000, a 92% increase from 2,255,000inthesameperiodof2023[130].Thecompanyrecorded2,255,000 in the same period of 2023 [130]. - The company recorded 0.9 million and 2.4millionofgrantincomerelatedtotheCPRITgrantasrevenueduringthethreeandninemonthsendedSeptember30,2024,respectively[146].ExpensesandLossesThecompanyincurred2.4 million of grant income related to the CPRIT grant as revenue during the three and nine months ended September 30, 2024, respectively [146]. Expenses and Losses - The company incurred 1.2 million and 3.1millioninexpensesrelatedtoservicesandmanufacturingcostsforthethreeandninemonthsendedSeptember30,2024,respectively[101].Researchanddevelopmentexpensesincreasedby703.1 million in expenses related to services and manufacturing costs for the three and nine months ended September 30, 2024, respectively [101]. - Research and development expenses increased by 70% to 3,471,000 for the three months ended September 30, 2024, up from 2,045,000inthesameperiodof2023[117].Generalandadministrativeexpensesdecreasedby392,045,000 in the same period of 2023 [117]. - General and administrative expenses decreased by 39% to 855,000 for the three months ended September 30, 2024, compared to 1,413,000inthesameperiodof2023[119].TotaloperatingexpensesforthethreemonthsendedSeptember30,2024,were1,413,000 in the same period of 2023 [119]. - Total operating expenses for the three months ended September 30, 2024, were 4,326,000, a 25% increase from 3,458,000inthesameperiodof2023[114].LossfromoperationsforthethreemonthsendedSeptember30,2024,was3,458,000 in the same period of 2023 [114]. - Loss from operations for the three months ended September 30, 2024, was (2,400,000), a 25% improvement from (3,200,000)inthesameperiodof2023[114].TotaloperatingexpensesfortheninemonthsendedSeptember30,2024,were(3,200,000) in the same period of 2023 [114]. - Total operating expenses for the nine months ended September 30, 2024, were 11,597,000, a 17% decrease from 13,898,000inthesameperiodof2023[130].NetlossfromcontinuingoperationsfortheninemonthsendedSeptember30,2024,was13,898,000 in the same period of 2023 [130]. - Net loss from continuing operations for the nine months ended September 30, 2024, was (6,895,000), a 39% improvement from (11,305,000)inthesameperiodof2023[130].OperatingexpensesforthethreeandninemonthsendedSeptember30,2024,were(11,305,000) in the same period of 2023 [130]. - Operating expenses for the three and nine months ended September 30, 2024, were 4.3 million and 11.6million,respectively,comparedto11.6 million, respectively, compared to 3.5 million and 13.9millionintheprioryearperiods[152].GrantsandFundingThecompanyreceiveda13.9 million in the prior year periods [152]. Grants and Funding - The company received a 2.0 million grant from the National Institutes of Health SBIR Program in August 2024 to support the advancement of MT-601 in patients with pancreatic cancer [107]. - The company received notice of a 2.0milliongrantfromtheNationalInstitutesofHealthSBIRProgramtosupporttheclinicalinvestigationofMT601inpatientswithnonHodgkinslymphomawhohaverelapsedfollowingantiCD19CARTcelltherapy[108].Thecompanyreceiveda2.0 million grant from the National Institutes of Health SBIR Program to support the clinical investigation of MT-601 in patients with non-Hodgkin's lymphoma who have relapsed following anti-CD19 CAR T cell therapy [108]. - The company received a 2.0 million grant from the FDA's Orphan Products Grant program for the clinical investigation of MT-401, with 1.0millionreceivedtodate[147].Thecompanyhasreceivedatotalofapproximately1.0 million received to date [147]. - The company has received a total of approximately 13.1 million from the CPRIT grant, with 9.7millionreceivedtodate[146].FinancialPositionCashandcashequivalentsasofSeptember30,2024,were9.7 million received to date [146]. Financial Position - Cash and cash equivalents as of September 30, 2024, were 9,000,000, down from 15,111,000asofDecember31,2023[137].AsofSeptember30,2024,thecompanyhadworkingcapitalof15,111,000 as of December 31, 2023 [137]. - As of September 30, 2024, the company had working capital of 7.4 million, down from 14.1millionasofDecember31,2023[152].Thecompanyanticipatesneedingsubstantialadditionalfundingforongoingoperationsandmayneedtoraisecapitalsoonerthanplanned[152].ThecompanyhasenteredintoanATMAgreementallowingforthesaleofupto14.1 million as of December 31, 2023 [152]. - The company anticipates needing substantial additional funding for ongoing operations and may need to raise capital sooner than planned [152]. - The company has entered into an ATM Agreement allowing for the sale of up to 75.0 million in common stock, with net proceeds of approximately $37,000 from sales during the nine months ended September 30, 2024 [156]. Organizational Changes - The company implemented organizational changes in 2023, including a reduction in headcount and the appointment of Dr. Juan Vera as President and CEO [103]. - The company executed a one-for-ten reverse stock split on January 26, 2023, reducing the total number of authorized shares from 300 million to 30 million [106]. Market Conditions - High inflation and economic recession concerns have resulted in capital market volatility, potentially affecting the company's liquidity [155]. - The company plans to continue funding operations through equity and/or debt financing, which may dilute existing stockholders' interests [154].