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Prelude Therapeutics(PRLD) - 2024 Q3 - Quarterly Report
PRLDPrelude Therapeutics(PRLD)2024-11-06 21:27

Financial Performance - The company reported a net loss of 98.4millionfortheninemonthsendedSeptember30,2024,comparedtoanetlossof98.4 million for the nine months ended September 30, 2024, compared to a net loss of 88.8 million for the same period in 2023, with an accumulated deficit of 554.8millionasofSeptember30,2024[81].−NetlossforthethreemonthsendedSeptember30,2024,was554.8 million as of September 30, 2024[81]. - Net loss for the three months ended September 30, 2024, was 32.3 million, compared to a net loss of 30.6millioninthesameperiodof2023[93].−Thecompanyused30.6 million in the same period of 2023[93]. - The company used 82.1 million in cash for operating activities during the nine months ended September 30, 2024, reflecting a net loss of 98.4million[116].−CashusedinoperatingactivitiesfortheninemonthsendedSeptember30,2023,was98.4 million[116]. - Cash used in operating activities for the nine months ended September 30, 2023, was 83.5 million, with a net loss of 88.8million[117].−Thecompanyhadanetcashdecreaseof88.8 million[117]. - The company had a net cash decrease of 14.2 million for the nine months ended September 30, 2024[115]. Revenue Generation - The company has not recognized any revenue from product sales to date and does not expect to generate revenue in the foreseeable future[82]. - Revenue for the three months ended September 30, 2024, was 3.0millionfromalicenseagreement,arecognitionofperformanceobligationsrelatedtotheexclusivelicense[94].−ThecompanyrecognizesrevenueunderASC606,reflectingtheconsiderationexpectedtobereceivedforgoodsorservices[120].ResearchandDevelopment−PRT3789,afirst−in−classSMARCA2degrader,iscurrentlyinPhase1clinicaldevelopment,withinitialdatashowingpartialresponsesin4outof26evaluablepatientswithadvancedNSCLCoresophagealcancers[78].−ThecompanyinitiatedaPhase2clinicaltrialforPRT3789incombinationwithKEYTRUDA®inpatientswithSMARCA4−mutatedcancers[78].−PRT2527,aselectiveCDK9inhibitor,hasshownhighlevelsoftargetinhibitionandafavorablesafetyprofileinaPhase1multi−doseescalationstudy[80].−ThecompanyexpectstocompletethemonotherapydoseescalationforPRT2527inB−cellmalignanciesin2024,withinterimdatatobepresentedattheAmericanSocietyofHematologyAnnualMeetinginDecember2024[80].−Thecompanyanticipatessignificantincreasesinresearchanddevelopmentexpensesinthecomingyearsasitconductsclinicaltrialsandpreparesregulatoryfilings[88].−Researchanddevelopmentexpensesincreasedfrom3.0 million from a license agreement, a recognition of performance obligations related to the exclusive license[94]. - The company recognizes revenue under ASC 606, reflecting the consideration expected to be received for goods or services[120]. Research and Development - PRT3789, a first-in-class SMARCA2 degrader, is currently in Phase 1 clinical development, with initial data showing partial responses in 4 out of 26 evaluable patients with advanced NSCLC or esophageal cancers[78]. - The company initiated a Phase 2 clinical trial for PRT3789 in combination with KEYTRUDA® in patients with SMARCA4-mutated cancers[78]. - PRT2527, a selective CDK9 inhibitor, has shown high levels of target inhibition and a favorable safety profile in a Phase 1 multi-dose escalation study[80]. - The company expects to complete the monotherapy dose escalation for PRT2527 in B-cell malignancies in 2024, with interim data to be presented at the American Society of Hematology Annual Meeting in December 2024[80]. - The company anticipates significant increases in research and development expenses in the coming years as it conducts clinical trials and prepares regulatory filings[88]. - Research and development expenses increased from 26.3 million in Q3 2023 to 29.5millioninQ32024,primarilyduetoincreasedchemistry,manufacturing,andcontrolscosts[95].−FortheninemonthsendedSeptember30,2024,researchanddevelopmentexpensestotaled29.5 million in Q3 2024, primarily due to increased chemistry, manufacturing, and controls costs[95]. - For the nine months ended September 30, 2024, research and development expenses totaled 86.4 million, up from 73.1millioninthesameperiodof2023,anincreaseof73.1 million in the same period of 2023, an increase of 13.3 million[102]. Operating Expenses - Total operating expenses for Q3 2024 were 37.4million,upfrom37.4 million, up from 33.4 million in Q3 2023, reflecting an increase of 3.99million[93].−Generalandadministrativeexpensesrosefrom3.99 million[93]. - General and administrative expenses rose from 7.1 million in Q3 2023 to 7.9millioninQ32024,drivenbyhigherprofessionalfees[97].−GeneralandadministrativeexpensesfortheninemonthsendedSeptember30,2024,were7.9 million in Q3 2024, driven by higher professional fees[97]. - General and administrative expenses for the nine months ended September 30, 2024, were 22.5 million, compared to 21.8millioninthesameperiodof2023[105].CashandFinancing−AsofSeptember30,2024,thecompanyhad21.8 million in the same period of 2023[105]. Cash and Financing - As of September 30, 2024, the company had 153.6 million in cash, cash equivalents, and marketable securities, expected to fund operations into 2026[109]. - The company had 400millionremainingunderthe2024ShelfRegistrationStatementasofSeptember30,2024,whichwasdeclaredeffectiveonJune10,2024[112].−AsofSeptember30,2024,therewas400 million remaining under the 2024 Shelf Registration Statement as of September 30, 2024, which was declared effective on June 10, 2024[112]. - As of September 30, 2024, there was 187 million remaining under the 2021 Shelf Registration Statement, which expires on November 24, 2024[113]. - The company expects to finance operations through equity offerings, debt financings, collaborations, and strategic alliances until substantial product revenue is generated[114]. - Net cash provided by investing activities was 68.1millionfortheninemonthsendedSeptember30,2024,primarilyfrom68.1 million for the nine months ended September 30, 2024, primarily from 114.2 million in proceeds from maturities of marketable securities[118]. - Net cash used in financing activities for the nine months ended September 30, 2024, was primarily for principal payments on finance leases and offering costs related to the shelf registration statement[119]. - The company may need to relinquish valuable rights to technologies or future revenue streams if additional funds are raised through collaborations or strategic alliances[114]. Partnerships and Collaborations - A license agreement with Pathos AI, Inc. was established, granting an exclusive license for the PRMT5 inhibitor, PRT811, resulting in a 3.0millionupfrontpaymentandpotentialmilestonepaymentstotalingupto3.0 million upfront payment and potential milestone payments totaling up to 137 million[83]. - The partnership with AbCellera aims to develop precision antibody drug conjugates, with the first preclinical data demonstrating potent activity in various cancer models[78]. - The company has a diverse pipeline targeting high unmet medical needs, including multiple distinct programs such as kinases and precision antibody drug conjugates[76].