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Prelude Therapeutics(PRLD) - 2024 Q2 - Quarterly Report

Financial Performance - The company reported a net loss of 66.2millionforthesixmonthsendedJune30,2024,comparedtoanetlossof66.2 million for the six months ended June 30, 2024, compared to a net loss of 58.1 million for the same period in 2023, resulting in an accumulated deficit of 522.6millionasofJune30,2024[70].NetlossforthethreemonthsendedJune30,2024was522.6 million as of June 30, 2024[70]. - Net loss for the three months ended June 30, 2024 was 34.740 million, compared to a net loss of 30.431millionforthesameperiodin2023,reflectinga14.030.431 million for the same period in 2023, reflecting a 14.0% increase in losses[79]. - Total operating expenses for the six months ended June 30, 2024 were 71.507 million, up from 61.513millioninthesameperiodof2023,markinga16.061.513 million in the same period of 2023, marking a 16.0% increase[85]. - Research and development expenses increased from 24.966 million in Q2 2023 to 29.509millioninQ22024,representinga18.129.509 million in Q2 2024, representing a 18.1% increase[79]. - General and administrative expenses rose from 7.432 million in Q2 2023 to 7.655millioninQ22024,a3.07.655 million in Q2 2024, a 3.0% increase[79]. - Research and development expenses for the six months ended June 30, 2024 totaled 56.918 million, up from 46.800millioninthesameperiodof2023,a21.646.800 million in the same period of 2023, a 21.6% increase[86]. - The company has incurred recurring losses primarily due to research and development activities and negative cash flows from operations[70]. - The company plans to continue incurring significant expenses and operating losses for the foreseeable future as it seeks regulatory approval for its product candidates[70]. 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[71]. - The company has not yet commercialized any product and does not expect to generate revenue from product sales for several years[90]. Research and Development - The company is advancing its first-in-class SMARCA2 degrader, PRT3789, which is currently in Phase 1 clinical development, with expectations to conclude monotherapy dose escalation in 2024[67]. - PRT2527, a selective CDK9 inhibitor, has completed a Phase 1 multi-dose escalation study, showing high levels of target inhibition and a favorable safety profile, with further development planned in hematologic malignancies[68]. - The company expects to present interim Phase 1 data for PRT3789 at the European Society of Medical Oncology (ESMO) Congress 2024 on September 13, 2024[67]. - The company has received IND clearance for its lead oral molecule, PRT7732, which is expected to enter Phase 1 clinical development in the second half of 2024[68]. - The company anticipates significant increases in research and development expenses as it advances its product candidates through clinical trials and prepares for regulatory filings[74]. Cash Flow and Financing - As of June 30, 2024, the company had 179.8 million in cash, cash equivalents, and marketable securities, expected to fund operations into 2026[92]. - The company reported a net cash used in operating activities of 54.848millionforthesixmonthsendedJune30,2024,comparedto54.848 million for the six months ended June 30, 2024, compared to 57.802 million for the same period in 2023[98]. - Cash used in operating activities for the six months ended June 30, 2024, was 54.8million,comparedto54.8 million, compared to 57.8 million for the same period in 2023, reflecting a net loss of 66.2millionin2024and66.2 million in 2024 and 58.1 million in 2023[99]. - Net cash provided by investing activities for the six months ended June 30, 2024, was 57.3million,primarilyfrom57.3 million, primarily from 71.4 million in proceeds from maturities of marketable securities, while net cash used in investing activities in 2023 was 57.4million[100].NetcashprovidedbyfinancingactivitiesforthesixmonthsendedJune30,2024,wasprimarilyfromproceedsreceivedfromtheissuanceofcommonstockundertheemployeestockpurchaseplan,whilein2023itwas57.4 million[100]. - Net cash provided by financing activities for the six months ended June 30, 2024, was primarily from proceeds received from the issuance of common stock under the employee stock purchase plan, while in 2023 it was 111.1 million from the sale of common stock and pre-funded warrants[101]. - The company plans to raise up to 400millionthroughashelfregistrationstatementfiledinMay2024tosupportongoingoperationsandgrowthstrategies[95].AccountingandReportingThecompanyenteredintoalicenseagreementwithPathosAI,Inc.inMay2024,grantinganexclusive,sublicensable,worldwidelicenseforitsPRMT5inhibitor,PRT811,whichwillbeaccountedforunderASC606[102].Thecompanyrecognizesrevenuewhenthecustomerobtainscontrolofpromisedgoodsorservices,reflectingtheconsiderationexpectedinexchangeforthosegoodsorservices[102].ThecompanyhaselectedtotakeadvantageofexemptionsundertheJOBSAct,allowingittodelaytheadoptionofcertainaccountingstandardsuntiltheyapplytoprivatecompanies[104].Thecompanyisclassifiedasa"smallerreportingcompany,"withamarketvalueofstockheldbynonaffiliateslessthan400 million through a shelf registration statement filed in May 2024 to support ongoing operations and growth strategies[95]. Accounting and Reporting - The company entered into a license agreement with Pathos AI, Inc. in May 2024, granting an exclusive, sublicensable, worldwide license for its PRMT5 inhibitor, PRT811, which will be accounted for under ASC 606[102]. - The company recognizes revenue when the customer obtains control of promised goods or services, reflecting the consideration expected in exchange for those goods or services[102]. - The company has elected to take advantage of exemptions under the JOBS Act, allowing it to delay the adoption of certain accounting standards until they apply to private companies[104]. - The company is classified as a "smaller reporting company," with a market value of stock held by non-affiliates less than 700 million and annual revenue below $100 million[106]. - The company may continue to rely on exemptions from certain disclosure requirements as a smaller reporting company, including presenting only the two most recent fiscal years of audited financial statements[106]. - There were no material changes to the company's critical accounting policies and estimates during the three months ended June 30, 2024[103]. - The company is not required to provide quantitative and qualitative disclosures about market risk for the period ending June 30, 2024, as a smaller reporting company[107].