Pegcetacoplan

Luxa Biotechnology said Thursday that its stem cell therapy helped improve vision in a handful of people with a common form of an age-related eye condition. In its lowest dose cohort, the Phase 1/2a study enrolled six participants with dry age-related macular degeneration, or dry AMD, which leads to blurred vision or worse central vision. The six people each received a suspension of 50,000 adult retinal pigment epithelial stem cells, which are cells found in the eye. The cells were implanted under the macula, the part of the eye that’s responsible for central vision, or seeing what’s directly in front of you. The six participants also received immune suppression for the first six months after receiving the stem cells. These patients were divided into two groups: a worse-seeing group and a better-seeing group. In the data shared this week, the three participants in the worse-seeing group were followed for 12 months, showing an average gain of +21.67 letters on an ETDRS chart, a vision test that measures how well a person can see. The three participants in the better-seeing group saw a +3.3-letter improvement at three months. Some of the participants were close to legal blindness, according to Luxa CEO Keith Dionne. “It was heartening to know that the worse-seeing subjects are the subjects most in need of vision improvement, and it was good to find that they had the largest improvement,” Luxa CMO Jeffrey Stern said in an interview. “With magnification, they can read, possibly drive with daytime driving, restricted driving. But importantly, it reverses the disease progression, which is inexorable, gradual loss.” Stern said that there were no significant safety events to date. The data were presented Thursday at the annual Wills Eye Conference in Philadelphia. Luxa is a joint venture operated by the Korean tech company Y2 Solution and the Neural Stem Cell Institute, an organization based in Albany, NY that was founded by stem cell pioneer Sally Temple and Stern. (The two are married.) Temple also serves as the biotech’s chief scientist. In recent years, two new treatments — Astellas’ Izervay and Apellis’ Syfovre — have been approved for geographic atrophy, the advanced form of dry AMD. Dry AMD accounts for around 80% of cases of age-related macular degeneration, which is one of the leading causes of blindness in the elderly. Luxa is also studying higher dose groups, which includes six participants at 150,000 cells and six at 250,000 cells. The biotech hopes to have initial results from the mid-dose cohort of 150,000 cells later this year, Stern said.

Reported $781.4 million in full year 2024 revenues, representing 97% year-over-year growth SYFOVRE® (pegcetacoplan injection) full year 2024 net product revenue of $611.9 million EMPAVELI® (pegcetacoplan) full year 2024 net product revenue of $98.1 million Submitted a supplemental new drug application (sNDA) for approval of EMPAVELI for C3G and primary IC-MPGN; U.S. launch anticipated in 2H 2025, if approved On track to initiate two Phase 3 trials of EMPAVELI in focal segmental glomerulosclerosis (FSGS) and in delayed graft function (DGF) in 2H 2025 Cash and cash equivalents of $411.3 million as of December 31, 2024; projected revenues and cash expected to be sufficient to fund operations to profitability Management to host conference call today at 8:30 a.m. ET SYFOVRE® (pegcetacoplan injection) full year 2024 net product revenue of $611.9 million EMPAVELI® (pegcetacoplan) full year 2024 net product revenue of $98.1 million WALTHAM, Mass., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), today announced its fourth quarter and full year 2024 financial results and business highlights. “Apellis made significant strides in 2024, highlighted by the continued growth of SYFOVRE and the unprecedented phase 3 results for EMPAVELI in C3G and IC-MPGN,” said Cedric Francois, M.D., Ph.D., chief executive officer at Apellis. “With two potential blockbuster products, a promising pipeline to fuel long-term growth, and a strong financial foundation, we are well positioned for continued growth in 2025 and beyond.” Fourth Quarter and Full Year 2024 Business Highlights and Upcoming Milestones Transforming the treatment of geographic atrophy (GA) secondary to age-related macular degeneration SYFOVRE: Reported $167.8 million and $611.9 million in SYFOVRE U.S. net product revenue for the fourth quarter and full year 2024, respectively. Delivered approximately 94,000 SYFOVRE doses to physician practices in the fourth quarter, including approximately 89,000 commercial vials and 4,600 samples. More than 510,000 SYFOVRE injections are estimated to have been administered since launch through December 2024, including clinical trials. Presented 48-month data from the GALE extension study at The Macula Society Annual Meeting in February 2025 demonstrating that early treatment with SYFOVRE leads to preservation of retinal tissue at magnitudes of approximately 1.5 disc areas, which is equivalent to the size of 2 foveal areas, in nonsubfoveal patients dosed monthly. Received approval in Australia from Therapeutic Goods Administration (TGA) for every-other-month treatment of adult patients with GA with an intact fovea and when central vision is threatened by GA lesion growth. APL-3007 (siRNA) + SYFOVRE Expect initiation of a Phase 2 multi-dose study of APL-3007 + SYFOVRE in 2Q 2025; potential next generation treatment aimed at comprehensively blocking complement activity in the retina and choroid. Reported $167.8 million and $611.9 million in SYFOVRE U.S. net product revenue for the fourth quarter and full year 2024, respectively. Delivered approximately 94,000 SYFOVRE doses to physician practices in the fourth quarter, including approximately 89,000 commercial vials and 4,600 samples. More than 510,000 SYFOVRE injections are estimated to have been administered since launch through December 2024, including clinical trials. Presented 48-month data from the GALE extension study at The Macula Society Annual Meeting in February 2025 demonstrating that early treatment with SYFOVRE leads to preservation of retinal tissue at magnitudes of approximately 1.5 disc areas, which is equivalent to the size of 2 foveal areas, in nonsubfoveal patients dosed monthly. Received approval in Australia from Therapeutic Goods Administration (TGA) for every-other-month treatment of adult patients with GA with an intact fovea and when central vision is threatened by GA lesion growth. More than 510,000 SYFOVRE injections are estimated to have been administered since launch through December 2024, including clinical trials. Expect initiation of a Phase 2 multi-dose study of APL-3007 + SYFOVRE in 2Q 2025; potential next generation treatment aimed at comprehensively blocking complement activity in the retina and choroid. Maximizing EMPAVELI impact in rare diseases Paroxysmal nocturnal hemoglobinuria (PNH): Recorded $23.4 million and $98.1 million in EMPAVELI U.S. net product revenue for the fourth quarter and full year 2024, respectively. Continued high patient compliance rates of 97%. C3 glomerulopathy (C3G) and primary immune complex glomerulonephritis (IC-MPGN): Submitted a sNDA for approval of EMPAVELI based on positive Phase 3 VALIANT results at six months; if approved, U.S. launch expected in 2H 2025. Sobi received validation from the European Medicines Agency for its indication extension application for Aspaveli® (pegcetacoplan). Focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF) Expect initiation of two Phase 3 studies in 2H 2025, one in FSGS and one in DGF, two rare kidney diseases in which the complement pathway plays a significant role and there are no approved therapies. Recorded $23.4 million and $98.1 million in EMPAVELI U.S. net product revenue for the fourth quarter and full year 2024, respectively. Continued high patient compliance rates of 97%. Submitted a sNDA for approval of EMPAVELI based on positive Phase 3 VALIANT results at six months; if approved, U.S. launch expected in 2H 2025. Sobi received validation from the European Medicines Agency for its indication extension application for Aspaveli® (pegcetacoplan). Expect initiation of two Phase 3 studies in 2H 2025, one in FSGS and one in DGF, two rare kidney diseases in which the complement pathway plays a significant role and there are no approved therapies. Advancing innovative pipeline, leveraging complement expertise Advancing investigational pre-clinical research for one-time neonatal Fc receptor (FcRn) treatment using gene editing technology from Beam Therapeutics. Organizational Updates David Acheson, previously the North America senior vice president of commercial, is now serving as the executive vice president of commercial following the recent departure of Adam Townsend, chief operating officer. Mr. Acheson joined Apellis in 2019 and has led the successful U.S. launches of EMPAVELI and SYFOVRE. Keli Walbert was recently appointed to the Apellis Board of Directors. Ms. Walbert brings more than two decades of biopharmaceutical commercial leadership experience to the Board. She most recently served as executive vice president, U.S. commercial, at Horizon Therapeutics, where she was responsible for driving commercial strategy and organizational development. Fourth Quarter and Full Year 2024 Financial Results Total Revenue. Total revenue was $212.5 million for the fourth quarter of 2024, which consisted of $167.8 million in U.S. net product revenue of SYFOVRE, $23.4 million in U.S. net product revenue of EMPAVELI and $21.4 million in licensing and other revenue associated with the Sobi collaboration. Total revenue was $146.4 million for the fourth quarter of 2023, which consisted of $114.3 million in U.S. net product revenue of SYFOVRE, $24.4 million in U.S. net product revenue of EMPAVELI and $7.7 million in licensing and other revenue associated with the Sobi collaboration. For the full year 2024, total revenue was $781.4 million, which consisted of $611.8 million in U.S. net product revenue of SYFOVRE, $98.1 million in U.S. net product revenue of EMPAVELI and $71.4 million in licensing and other revenue associated with the Sobi collaboration. For the full year 2023, total revenue was $396.6 million, which consisted of $275.2 million in U.S. net product revenue of SYFOVRE, $91.0 million in U.S. net product revenue of EMPAVELI and $30.3 million in licensing and other revenue associated with the Sobi collaboration. Total revenue was $146.4 million for the fourth quarter of 2023, which consisted of $114.3 million in U.S. net product revenue of SYFOVRE, $24.4 million in U.S. net product revenue of EMPAVELI and $7.7 million in licensing and other revenue associated with the Sobi collaboration. For the full year 2023, total revenue was $396.6 million, which consisted of $275.2 million in U.S. net product revenue of SYFOVRE, $91.0 million in U.S. net product revenue of EMPAVELI and $30.3 million in licensing and other revenue associated with the Sobi collaboration. Cost of Sales. Cost of sales was $40.9 million for the fourth quarter of 2024, compared to $19.9 million for the fourth quarter of 2023. For the full year 2024, cost of sales was $117.7 million as compared to $58.5 million for the full year 2023. Cost of sales consists primarily of costs associated with the manufacturing of SYFOVRE and EMPAVELI, royalties owed to our licensor for such sales, costs associated with Sobi revenue, and certain period costs. Cost of sales consists primarily of costs associated with the manufacturing of SYFOVRE and EMPAVELI, royalties owed to our licensor for such sales, costs associated with Sobi revenue, and certain period costs. R&D Expenses. R&D expenses were $76.4 million for the fourth quarter of 2024, compared to $69.3 million for the fourth quarter in 2023. For the full year 2024, R&D expenses were $327.6 million compared to $354.4 million for the full year 2023. The decrease in R&D expenses for the full year ended December 31, 2024, was primarily attributable to a decrease in compensation and related personnel costs, which was partially offset by an increase in program specific external costs. The decrease in R&D expenses for the full year ended December 31, 2024, was primarily attributable to a decrease in compensation and related personnel costs, which was partially offset by an increase in program specific external costs. Selling, General and Administrative (SG&A) Expenses. SG&A expenses were $121.5 million for the fourth quarter of 2024, compared to $141.7 million for the fourth quarter in 2023. For the full year 2024, G&A expenses were $501.1 million compared to $500.8 million for the full year 2023. The increase was primarily attributable to an increase in office expenses, an increase in factoring fees, an increase in travel expenses, and an increase in insurance expenses, which were partially offset by a decrease in professional and consulting fees and a decrease in personnel-related costs. The increase was primarily attributable to an increase in office expenses, an increase in factoring fees, an increase in travel expenses, and an increase in insurance expenses, which were partially offset by a decrease in professional and consulting fees and a decrease in personnel-related costs. Net Loss. Apellis reported a net loss of $36.4 million and $197.9 million for the fourth quarter and full year 2024, respectively, compared to a net loss of $88.5 million and $528.6 million for the same periods in 2023. Cash. As of December 31, 2024, Apellis had $411.3 million in cash and cash equivalents, compared to $351.2 million in cash and cash equivalents as of December 31, 2023. Apellis anticipates its cash, combined with expected product revenues, will be sufficient to fund its projected operating expenses and capital expenditures to profitability. Conference Call and WebcastApellis will host a conference call and webcast to discuss its fourth quarter and full year 2024 financial results and business highlights today, February 28, 2025, at 8:30 a.m. ET. To access the live call by phone, please pre-register for the call here. A live audio webcast of the event and accompanying slides may also be accessed through the “Events and Presentations” page of the “Investors and Media” section of the company’s website. A replay of the webcast will be available for 30 days following the event. About SYFOVRE® (pegcetacoplan injection)SYFOVRE® (pegcetacoplan injection) is the first-ever approved therapy for geographic atrophy (GA). By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. SYFOVRE is approved in the United States and Australia. About EMPAVELI®/Aspaveli® (pegcetacoplan)EMPAVELI®/Aspaveli® (pegcetacoplan) is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. It is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in the United States, European Union, and other countries globally. The therapy is also under investigation for several other rare diseases across hematology and nephrology. U.S. Important Safety Information for SYFOVRE® (pegcetacoplan injection) CONTRAINDICATIONS SYFOVRE is contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation, and in patients with hypersensitivity to pegcetacoplan or any of the excipients in SYFOVRE. Systemic hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria) have occurred. WARNINGS AND PRECAUTIONS Endophthalmitis and Retinal Detachments Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Retinal Vasculitis and/or Retinal Vascular Occlusion Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay. Neovascular AMD In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration. Intraocular Inflammation In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE. Increased Intraocular Pressure Acute increase in IOP may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed. Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay. In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration. In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE. Acute increase in IOP may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed. ADVERSE REACTIONS Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage. Please see accompanying full Prescribing Information for more information. U.S. Important Safety Information for EMPAVELI® (pegcetacoplan) BOXED WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, unless the risks of delaying therapy with EMPAVELI outweigh the risks of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. Patients receiving EMPAVELI are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected. Because of the risk of serious infections caused by encapsulated bacteria, EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS. CONTRAINDICATIONS Hypersensitivity to pegcetacoplan or to any of the excipients For initiation in patients with unresolved serious infection caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B WARNINGS AND PRECAUTIONS Serious Infections Caused by Encapsulated Bacteria EMPAVELI, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis (caused by any serogroup, including non-groupable strains), and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of EMPAVELI treatment is contraindicated in patients with unresolved serious infection caused by encapsulated bacteria. Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of EMPAVELI, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI. Note that, ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. The benefits and risks of treatment with EMPAVELI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria. Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of EMPAVELI in patients who are undergoing treatment for serious infections. EMPAVELI is available only through a restricted program under a REMS. EMPAVELI REMS EMPAVELI is available only through a restricted program under a REMS called EMPAVELI REMS, because of the risk of serious infections caused by encapsulated bacteria. Notable requirements of the EMPAVELI REMS include the following: Under the EMPAVELI REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risks, signs, and symptoms of serious infections caused by encapsulated bacteria, provide patients with the REMS educational materials, ensure patients are vaccinated against encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, prescribe antibacterial drug prophylaxis if patients’ vaccine status is not up to date and treatment must be started urgently, and provide instructions to always carry the Patient Safety Card both during treatment, as well as for 2 months following last dose of EMPAVELI. Pharmacies that dispense EMPAVELI must be certified in the EMPAVELI REMS and must verify prescribers are certified. Further information is available at www.empavelirems.com or 1-888-343-7073. Infusion-Related Reactions Systemic hypersensitivity reactions (e.g., facial swelling, rash, urticaria) have occurred in patients treated with EMPAVELI. One patient (less than 1% in clinical studies) experienced a serious allergic reaction which resolved after treatment with antihistamines. If a severe hypersensitivity reaction (including anaphylaxis) occurs, discontinue EMPAVELI infusion immediately, institute appropriate treatment, per standard of care, and monitor until signs and symptoms are resolved. Monitoring PNH Manifestations after Discontinuation of EMPAVELI After discontinuing treatment with EMPAVELI, closely monitor for signs and symptoms of hemolysis, identified by elevated LDH levels along with sudden decrease in PNH clone size or hemoglobin, or reappearance of symptoms such as fatigue, hemoglobinuria, abdominal pain, dyspnea, major adverse vascular events (including thrombosis), dysphagia, or erectile dysfunction. Monitor any patient who discontinues EMPAVELI for at least 8 weeks to detect hemolysis and other reactions. If hemolysis, including elevated LDH, occurs after discontinuation of EMPAVELI, consider restarting treatment with EMPAVELI. Interference with Laboratory Tests There may be interference between silica reagents in coagulation panels and EMPAVELI that results in artificially prolonged activated partial thromboplastin time (aPTT); therefore, avoid the use of silica reagents in coagulation panels. ADVERSE REACTIONS Most common adverse reactions in patients with PNH (incidence ≥10%) were injection site reactions, infections, diarrhea, abdominal pain, respiratory tract infection, pain in extremity, hypokalemia, fatigue, viral infection, cough, arthralgia, dizziness, headache, and rash. USE IN SPECIFIC POPULATIONS Females of Reproductive Potential EMPAVELI may cause embryo-fetal harm when administered to pregnant women. Pregnancy testing is recommended for females of reproductive potential prior to treatment with EMPAVELI. Advise female patients of reproductive potential to use effective contraception during treatment with EMPAVELI and for 40 days after the last dose. Please see full Prescribing Information, including Boxed WARNING regarding serious infections caused by encapsulated bacteria, and Medication Guide. About ApellisApellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first-ever therapy for geographic atrophy, a leading cause of blindness around the world. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit http://apellis.com or follow us on X (formerly Twitter) and LinkedIn. Apellis Forward-Looking StatementStatements in this press release 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,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the results of the Company’s clinical trials for EMPAVELI, SYFOVRE, or any of its future products will warrant regulatory submissions to the FDA or equivalent foreign regulatory agencies; whether systemic pegcetacoplan will receive approval from the FDA or equivalent foreign regulatory agencies for C3G and IC-MPGN or any other indication when expected or at all; rate and degree of market acceptance and clinical utility of EMPAVELI, SYFOVRE and any future products for which we receive marketing approval will impact our commercialization efforts; whether SYFOVRE will receive approval from foreign regulatory agencies for GA when expected or at all; whether the Company’s clinical trials will be completed when anticipated; whether results obtained in clinical trials will be indicative of results that will be generated in future clinical trials or in the real world setting; whether the period for which the Company believes that its cash resources will be sufficient to fund its operations; and other factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the Securities and Exchange Commission on February 28, 2025 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Media Contact:Lissa Pavlukmedia@apellis.com617.977.6764 Investor Contact:Meredith Kayameredith.kaya@apellis.com617.599.8178