Apellis Pharmaceuticals Inc.'s (APLS:NASDAQ) immediate focus is on getting its C3 inhibitor Empaveli (pegcetacoplan) approved in the U.S. and the European Union for geographic atrophy, reported Oppenheimer analyst Justin Kim in a March 9 research note.
Oppenheimer and Kim "stay bullish," he wrote.
Geographic atrophy, an advanced form of atrophic age-related macular degeneration, is a severe late-stage disease for which there are no current treatments, noted Kim. The leading cause of blindness, geographic atrophy affects 5 million people globally.
As for the timeline regarding approval in this indication, Apellis intends to submit a new drug application to the U.S. Food and Drug Administration (FDA) in Q2/22. In that filing, it will include the pending 18-month data from two Phase 3 studies: DERBY and OAKS. Subsequently, in H2/22, the U.S.-based biopharma plans to submit a marketing authorization application to the European Medicines Agency.
"We believe the opportunity set for the drug in the eye could rival (and potentially exceed) those of Eylea (aflibercept), which also faces branded (ranibizumab) and 'generic' (compounded avastin) competition," Kim wrote.
The analyst pointed out that Empaveli already is FDA approved for paroxysmal nocturnal hemoglobinuria, and the commercial rollout in that indication continues. The drug generated $15.1 million in revenues in 2021.
"How C3 inhibition expands, as opportunities such as coronary artery disease potentially fly under the radar, could drive the long-term commercial potential for Empaveli," highlighted Kim.
Also noteworthy, Kim noted, the next one to two years are expected to be catalyst rich with the company achieving numerous clinical milestones in various complement-mediated diseases. They include amyotrophic lateral sclerosis, or ALS (neurology); coronary artery disease and immune complex membranoproliferative glomerulonephritis, or IC-MPGN (hematology); and complement 3 glomerulopathy, or C3G (nephrology).
Specific potential stock moving events for Apellis in H1/22 alone include the starts of two Phase 3 Empaveli clinical trials: one in IC-MPGN, the other in C3G. Completion of enrollment for the Phase 2 ALS study is also expected then. Several additional catalysts are anticipated in H2/22.
Apellis, having ended 2021 with $700.6 million in cash, cash equivalents, and investments, is adequately funded to get it well into Q3/22, Kim wrote.
Oppenheimer has an Outperform rating and a $65 per share price target on Apellis. Its stock is currently trading at around $42.50 per share.
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