Core Insights - Checkpoint Therapeutics is awaiting a decision from the U.S. FDA on its Biologics License Application (BLA) resubmission for cosibelimab, with a PDUFA goal date set for December 28, 2024 [2][3] - The company has strengthened its financial position with 9.2millionincashproceedsfromwarrantexercises,allowingittoextendoperationsbeyondthePDUFAdateinto2025[2][3]−Checkpointisfocusedonpreparingforthepotentialapprovalofcosibelimab,whichisaimedattreatingadvancedcutaneoussquamouscellcarcinoma(cSCC)[2][3]RecentCorporateUpdates−TheFDAacceptedtheresubmissionoftheBLAforcosibelimabinJuly2024,addressingissuesfromapreviouscompleteresponseletterissuedinDecember2023[3]−AcollaborationwasannouncedinJuly2024toexplorethecombinedtherapeuticpotentialofcosibelimabwithGCCell′sImmuncell−LC[3]−CheckpointcompletedadirectofferingandprivateplacementinJuly2024,raisingapproximately12.0 million [3] - Longer-term data from a pivotal trial of cosibelimab was presented at the ESMO Congress 2024, showing improved response rates over time [3] - The company received 9.2millionincashproceedsfromwarrantexercisesinNovember2024[3]FinancialResults−AsofSeptember30,2024,Checkpoint′scashandcashequivalentstotaled4.7 million, a decrease from 5.0millionatJune30,2024[4]−ResearchanddevelopmentexpensesforQ32024were6.4 million, up from 5.5millioninQ32023[4]−GeneralandadministrativeexpensesforQ32024were3.4 million, compared to 2.2millioninQ32023[4]−ThenetlossforQ32024was9.7 million, or 0.23pershare,comparedtoanetlossof5.7 million, or $0.29 per share, in Q3 2023 [4][10]