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2024-05-10 10:33 Apellis Pharmaceuticals Reports First Quarter 2021 Financial Results - Apellis Pharmaceuticals , Inc. Release Details Apellis Pharmaceuticals Reports First Quarter 2021 Financial Results April 28 , 2021 Marketing application for pegcetacoplan for paroxysmal nocturnal hemoglobinuria ( PNH ) is under review by the U.S. Food and Drug Administration ( FDA ) with a PDUFA target action date of May 14 , 2021 Top - line results from the Phase 3 PRINCE study in treatment - naïve PNH patients expected in the second quarter of 2021 Top - line results from Phase 3 geographic atrophy ( GA ) studies expected in the third quarter of 2021 Three new product candidates advancing into clinical development by the end of 2022 Cash and investments of $ 723.7 million as of March 31 , 2021 support cash runway into the second half of 2022 Conference call scheduled today at 4:30 p.m. ET WALTHAM , Mass . , April 28 , 2021 ( GLOBE NEWSWIRE ) -- Apellis Pharmaceuticals , Inc. ( Nasdaq : APLS ) , a global biopharmaceutical company and leader in targeted C3 therapies , today announced its first quarter 2021 financial results and business highlights . " With a potential U.S. approval for pegcetacoplan just a couple of weeks away , we are at the beginning of a transformational year for Apellis . Our commercial team is prepared to successfully execute our first product launch and meet the needs of PNH patients , " said Cedric Francois , M.D. , Ph.D. , co - founder and chief executive officer of Apellis . " At the same time , we are focused on advancing registrational programs of pegcetacoplan across several debilitating rare diseases and delivering on our goal to become number one in the retina . Geographic atrophy is the most significant remaining unmet need in the retina , and we are excited to see top - line results from our Phase 3 studies of pegcetacoplan in GA in the third quarter of this year . " For more than a decade , our team has built the foundation for Apellis ' leadership in complement , and we look forward to seeing the results of those efforts come together this year for patients living with serious , complement - driven diseases , " Dr. Francois continued . First Quarter 2021 Business Highlights and Upcoming Milestones : Systemic Pegcetacoplan in Rare Disease In March 2021 , Apellis and Sobi announced that the New England Journal of Medicine published results from the Phase 3 PEGASUS study . The data at 16 weeks showed that pegcetacoplan , an investigational targeted C3 therapy , demonstrated statistically superior increases in mean hemoglobin levels compared with the C5 inhibitor SolirisⓇ ( eculizumab ) and provided substantial improvements in other key markers of disease in adults with PNH who had persistent anemia following treatment with Soliris . Marketing applications for pegcetacoplan for the treatment of PNH are under review by the U.S. Food and Drug Administration ( FDA ) and the European Medicines Agency ( EMA ) . The New Drug Application was granted Priority Review by the FDA with a Prescription Drug User Fee Act ( PDUFA ) target action date of May 14 , 2021. The Marketing Authorization Application has the potential for a European Commission decision in the second half of 2021 . In the second quarter of 2021 , Apellis and Sobi expect to report top - line results from the Phase 3 PRINCE study in PNH patients who are treatment naïve . In the second half of 2021 , Apellis expects to initiate a Phase 3 study in immune complex membranoproliferative glomerulonephritis ( IC - MPGN ) and C3 glomerulopathy ( C3G ) , and Sobi plans to initiate a Phase 3 study in cold agglutinin disease ( CAD ) and a potentially registrational Phase 2 study in hematopoietic stem cell transplantation- associated thrombotic microangiopathy ( HSCT - TMA ) . Intravitreal Pegcetacoplan in Ophthalmology https://investors.apellis.com/news-releases/news-release-details/apellis-pharmaceuticals-reports-first-quarter-2021-financial 15 1/5