EMPAVELI Launch and PNH Market - EMPAVELI (pegcetacoplan)获得美国FDA批准，成为首个获批的靶向C3疗法，用于治疗成人阵发性睡眠性血红蛋白尿症(PNH)[4, 5] - 美国现有约1500名接受补体治疗的PNH患者，每年新增约150名符合条件的PNH患者[10] - EMPAVELI上市初期反馈积极，医生已注册REMS项目，处方到首剂给药的平均时间为12天[9, 14] - 约75%从C5抑制剂转换到EMPAVELI的患者来自Ultomiris[14] PRINCE Trial Results - PRINCE试验在第26周达到主要终点，EMPAVELI组86%的患者实现血红蛋白稳定，而标准治疗组(SOC)为0%(p<0.0001)[20] - EMPAVELI组乳酸脱氢酶(LDH)降低90%，SOC组为14%(p<0.0001)[20] - EMPAVELI组9%的患者出现严重不良事件(SAE)，SOC组为17%[21] Pipeline Expansion - Apellis正在推进多种疾病的治疗方案，包括IC-MPGN/C3G、ALS、CAD和HSCT-TMA，预计在2021年下半年启动多项3期临床试验[23] - Apellis计划在2022年提交siRNA + EMPAVELI的IND申请，用于现有和新的适应症[33] Geographic Atrophy (GA) Program - DERBY和OAKS是两项针对GA患者的3期临床试验，共有1258名患者参与，预计9月份公布顶线结果[25] - Apellis计划在2022年启动一项针对中间期AMD的关键研究，前提是DERBY和OAKS的月度治疗组达到主要疗效终点[31] Financial Results - 2021年第二季度，净产品收入和总收入均为60万美元[32] - 研发费用为9590万美元，研究合作成本为5000万美元，一般及行政管理费用为4900万美元[32] - 净亏损为2.192亿美元[32] - 截至2021年6月30日，Apellis的现金为5.99亿美元，预计可为公司目前的运营计划提供资金至2022年下半年[32]

Leaders in Complement January 2022 Forward-looking statements Statements in this presentation about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "wo ...