Apellis trims staff, shrinks R&D plans to save money in face of looming competition in ophthalmology

Apellis Pharmaceuticals is in cash-saving mode as it looks to ward off a newly-minted competitor in treating a leading cause of blindness.

The drugmaker said Monday morning it will lay off about 225 employees — accounting for 25% of its current workforce — shrink external expenses and slim down its R&D. The Boston-area biotech expects to save $300 million through next year, and it characterized the trimmings as a path to securing Apellis’ “long-term success.”

Cedric Francois

“As a more focused organization, we believe these initiatives put Apellis in a stronger position to create value for shareholders and continue delivering on our mission for patients now and in the future,” co-founder and CEO Cedric Francois said in a statement.

The company will place emphasis on the US commercialization of its retinal treatment Syfovre, which reeled in $85.7 million in net product revenues in the first half of the year and is due for an EU regulatory decision early in 2024. Reviews of Syfovre (intravitreal pegcetacoplan) in Canada, Australia, the UK and Switzerland are expected to wrap up in the first half of next year as well.

Apellis was set for a solid year with the first-ever FDA approval for a geographic atrophy treatment in February, but rare inflammatory side effects found during the rollout — later deemed likely related to the injection kit and not the drug — dented the biotech’s stock over the summer. Then came the approval of Izervay, a competing drug from Astellas’ Iveric Bio in early August.

As part of the reductions, Apellis will limit expenses on the systemic version of pegcetacoplan, marketed as Empaveli for paroxysmal nocturnal hemoglobinuria, a rare blood disease. The medicine generated $42.7 million in net revenues in the US last year, with more than 230 people on the commercial drug at the end of June, Apellis said.

The company will limit further research of systemic pegcetacoplan and zoom in on two, rare kidney diseases: immune complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G). Apellis anticipates topline data from a Phase III study, dubbed VALIANT, in those indications next year.

Systemic pegcetacoplan was also being studied in trials for amyotrophic lateral sclerosis and cold agglutinin disease, as well as transplant-associated thrombotic microangiopathy (TA-TMA) after patients received a hematopoietic stem cell transplantation. The discontinuation in ALS was disclosed in May, after the drug failed to help patients with the fatal neurodegenerative disease in a Phase II trial.

Apellis also said it’s focusing research on retinal and CNS diseases. Certain programs will be deprioritized, including preclinical neurology asset APL-1030, ophthalmology-focused APL-2006 and combining siRNA with systemic pegcetacoplan. Its Beam Therapeutics collaboration will remain in place as the duo tries applying base editing to new treatments for complement-driven diseases, Apellis said.

therapeutics
pharmaceuticals
biotech
fda
research