Business
Apellis Pharmaceuticals Reports Third Quarter 2019 Business Update and Financial Results
Dosed First Patient in Phase 3 Study of APL-2 for Treatment-Naïve Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Completed $220 Million Offering of
About this update from Apellis Pharmaceuticals, Inc.
[{"type":"text","content":"Dosed First Patient in Phase 3 Study of APL-2 for Treatment-Naïve Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)\n Completed $220 Million Offering of Convertible Senior Notes Due 2026 Cash Position of $434.0 Million at Quarter-End WALTHAM Mass., and CRESTWOOD, Ky., Nov. 05, 2019 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, today announced its third quarter 2019 financial results and business highlights. “Apellis made continued clinical and business progress in the third quarter of 2019, highlighted by dosing the first patient in the Phase 3 PRINCE study for treatment-naïve patients with PNH and significantly extending our cash runway through a convertible senior notes offering,” said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer of Apellis. “We look forward to presenting preliminary data on APL-2 in C3 glomerulopathy at the American Society of Nephrology Kidney Week later this week and releasing topline data from our Phase 3 PEGASUS trial of APL-2 in patients with PNH in January 2020.” Business Highlights and Upcoming Milestones: APL-2 in Systemic Indications In October 2019, Apellis announced it will present preliminary clinical data on APL-2 (pegcetacoplan) in C3 glomerulopathy (C3G) at the American Society of Nephrology Kidney Week 2019 in Washington D.C. from Nov. 5-10. Data from eight patients in the C3G cohort of the Phase 2 DISCOVERY trial of APL-2 will be presented through study day 84 (12 weeks).In September 2019, Apellis announced the dosing of the first patient in the Phase 3 clinical study, PRINCE (APL2-308), evaluating the efficacy and safety of APL-2 for treatment-naïve patients with PNH. The PRINCE study is a randomized, multicenter, open-label, controlled study that aims to enroll 54 treatment-naïve adult patients with PNH.Apellis met with regulatory authorities this fall to discuss the program in cold agglutinin disease (CAD). The company will update plans and timing for further clinical development of APL-2 for patients with CAD in early 2020. APL-2 in Geographic Atrophy In September 2019, details about the company’s Phase 2 FILLY study investigating intravitreal APL-2 for the treatment of geogr...