GlobeNewswire Inc | Nov 13, 2020 10:40AM EST

November 13, 2020

-- Verana Health analysis of American Academy of Ophthalmology IRIS Registry presented in a late-breaking oral session -- Real-world clinical data show significant disease progression over a two-year period in more than 69,000 patients with GA, highlighting the urgent need for treatment -- Patients were nearly three times more likely to develop new onsetwet age-related macular degeneration(AMD) in an eye with GA when wet AMD had already been detected in the contralateral eye

WALTHAM, Mass., Nov. 13, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced findings from the largest retrospective database study in geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The analysis of the American Academy of Ophthalmology (AAO) IRIS (Intelligent Research in Sight) Registry, the nation's first comprehensive clinical registry for eye disease, was conducted in partnership with Verana Health, the worlds leading data analysis group in retinal diseases. The study highlights the significant impact of GA progression on vision, underscoring the high unmet need for GA treatment in clinical practice. The data were presented today in a late-breaking oral session as part of the Retina Subspecialty Day at AAO 2020 Virtual.

The retrospectivestudyincludedmore than 69,000patients diagnosed with GA and analyzedchanges invisual acuity and disease progression for over two years, as well as the occurrence of concurrent wet AMD.GA is a complement-driven eye disease1,2that can lead to significant vision loss andaffects approximately five million peoplearound the world.3,4

There is no approved therapy for GA and with new agents under development, it is essential to have a detailed understanding of disease progression in real-world clinical practice, said EhsanRahimy, M.D., lead study author and surgicalandmedical vitreoretinal specialist at the Palo Alto Medical Foundation. The data show that GA patients at their first encounter have useful vision that may be preserved if an effective treatment were available. The progressive loss of visual acuity observed in this study over a two-year period underscores the urgent need for a therapy to slow disease progression.

Key findings from the real-world clinical datashow:

-- Progression from GA to new onset wet AMD was observed in 4.7% of patients with bilateral GA (GA in both eyes) and 13.3% of patients with wet AMD in the contralateral eye during the first 12 months. The rate at 24 months was 8.2% and 21.6% in bilateral GA and wet AMD in the contralateral eye, respectively. -- At the firststudy visit, patientspresented with relatively preserved vision,especially in eyes with extrafoveal GA lesions (lesions outside the fovea, which is the central portion of the retina). However,patients with extrafovealand fovealGAlesionsprogressively lost visionover time at a rate of approximately five letters per year. -- A large proportion of GA patientsdidnot return for a follow-up visit after two years.Of the GA patients potentially eligible for inclusion in the analysis, only 40% had a follow-up visitaftertwoyears and were ultimately included in the study.

As we work to develop the first potentialmedicine for people withGA, we are committed toimprovingunderstandingofthedisease. Our collaboration with Verana Health and the AAO IRISRegistry showsthat wet AMD is not a rare occurrence in GA patients, and there is an opportunity to preserve vision if new treatments become available,said Federico Grossi, M.D., Ph.D., chief medical officer of Apellis.These resultshighlightthesignificantunmet need in GA, and we are working urgently to advancepegcetacoplan, a targeted C3 therapy, in twoongoingPhase 3GAstudies.

About the IRISRegistryThe American Academy of Ophthalmology IRIS(Intelligent Research in Sight) Registry is the nation's first electronic health record-based comprehensive eye disease and condition registry. As of September 2020, the registry features over 59.99 million unique patients and includes 16,030 clinicians. It is a centralized data repository and reporting tool that can analyze patient data to produce easy-to-interpret national and inter-practice benchmark reports and provide scientific information to improve public health. The reports can validate the quality of care ophthalmologists provide and pinpoint opportunities for improvement.

About Verana HealthVerana Health, Inc. partners with leading medical associations to transform clinical data into actionable real-world evidence. These partnerships enable Verana Health to harness the comprehensive data found in qualified clinical data registries and other specialty data sources to accelerate medical research and enhance patient care. Learn more at veranahealth.com.

About Geographic Atrophy (GA)GA is an advanced form of age-related macular degeneration (AMD), a leading cause of blindness. Excessive complement activation drives irreversible lesion growth in GA,5and C3 is the only target to precisely control complement overactivation.Pegcetacoplan, studied in early and late-stage trials comprising a total of approximately 1,500 patients, is the only targeted C3 inhibitor being evaluated in late-stage trials to control lesion growth in GA.6

GA lesions affect the central portion of the retina, known as the macula, which is responsible for central vision. GA is progressive and irreversible, leading to central visual impairment and permanent loss of vision. Based on published studies, approximately one million people have GA inthe United States and five million people have GA globally.2,7There are currently noapproved treatments for GA.

AboutPegcetacoplan(APL-2)Pegcetacoplanis an investigational, targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the bodys immune system, which can lead to the onset and progression of many serious diseases.Pegcetacoplanis a synthetic cyclic peptide conjugated to a polyethylene glycol polymer that binds specifically to C3 and C3b.Apellis is evaluatingpegcetacoplanin several clinical studies across hematology, ophthalmology, nephrology, and neurology.Pegcetacoplanwas granted Fast Track designation by the U.S. Food and Drug Administration (FDA) forthe treatment of paroxysmal nocturnal hemoglobinuria (PNH) and the treatment of geographicatrophy, andreceived orphan drug designation for the treatment of C3 glomerulopathy (C3G) by the FDA and European Medicines Agency. For additional information regarding our clinical trials,visit https://apellis.com/our-science/clinical-trials.

About ApellisApellis Pharmaceuticals, Inc. is a global biopharmaceutical company that is committed to leveraging courageous science, creativity, and compassion to deliver life-changing therapies. Leaders in targeted C3 therapies, we aim to develop transformative therapies for a broad range of debilitating diseases that are driven by excessive activation of the complement cascade, including those within hematology, ophthalmology, nephrology, and neurology. For more information, pleasevisit http://apellis.com.

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. These statements include, but are not limited to, statements relating to the implications of preliminary clinical data. 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 companys clinical trials will be fully enrolled and completed when anticipated; whether preliminary or interim results from a clinical trial will be predictive of the final results of the trial; whether results obtained in preclinical studies and clinical trials will be indicative of results that will be generated in future clinical trials; whetherpegcetacoplanwill successfully advance through the clinical trial process on a timely basis, or at all; whether the results of the companys clinical trials will warrant regulatory submissions and whetherpegcetacoplanwill receive approval from the FDA or equivalent foreign regulatory agencies for GA, PNH, CAD, C3G, IC-MPGN, ALS or any other indication when expected or at all; whether, if Apellis products receive approval, they will be successfully distributed and marketed; and other factors discussed in the Risk Factors section of Apellis Quarterly Report on Form 10-Q filed with theSecurities and Exchange Commissionon November 2, 2020and the risks described in other filings that Apellis may make with theSecurities 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.

MediaContact:Mark Dolemedia@apellis.com+1617997 3484

InvestorContact:Argot Partnersapellis@argotpartners.com+1212600 1902

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