Apellis Pharma : Scaling New Highs

(RTTNews) - Shares of Apellis Pharmaceuticals Inc. (APLS), which touched an all-time high of $30.25 in intraday trading yesterday, are up 132 percent year-to-date.

Apellis Pharma is a clinical-stage pharma company developing drugs for autoimmune and inflammatory diseases.

The Company's lead product candidate is APL-2 that is designed to target Complement C3 , a protein of the immune system. This compound is being tested for various indications like Paroxysmal Nocturnal Hemoglobinuria, Geographic Atrophy, Autoimmune hemolytic anemia, and Complement-dependent nephropathies.

A phase III trial comparing APL-2 against Alexion Pharmaceuticals' Soliris' in patients with paroxysmal nocturnal hemoglobinuria, dubbed PEGASUS, is underway. Top-line data from this trial is expected to be released in December 2019. PNH is a rare disease in which red blood cells break down earlier than they should.

A phase II study of APL-2 in patients with autoimmune hemolytic anemia (AIHA), including cold agglutinin disease (CAD) and warm antibody autoimmune hemolytic anemia (wAIHA), dubbed PLAUDIT, is ongoing. In June of this year, the company announced updated data from the PLAUDIT study, which demonstrated improvement both in important hematologic measures and in quality of life scores, particularly in CAD patients treated with APL-2.

APL-2 is expected to move into phase III trial in cold agglutinin disease in early 2020. Cold agglutinin is an auto immune disease in which the body's immune system attacks and destroys its own red blood cells leading to anemia.

Two phase III trials of APL-2 in patients with Geographic Atrophy (GA) are underway, and the trials are expected to be fully enrolled by the end of the first quarter of 2020.

Geographic Atrophy is an age-related degeneration of the centre of the retina that can result in loss of sight over a period of time.

A phase II monotherapy trial of APL-2 in four types of complement-dependent nephropathies (IgA nephropathy, C3 glomerulopathy, primary membranous nephropathy and lupus nephritis) is ongoing, with data expected to be presented in November.

Also in the pipeline is APL-9, a PEGylated peptide, which inhibits the Complement C3, and has the potential to treat a range of complement-mediated conditions.

In a phase I trial of APL-9 in healthy volunteers, the compound was well tolerated with no serious adverse events reported.

Key Numbers:

The company had an accumulated deficit of $398.43 million as of the second quarter of 2019. Cash and cash equivalents totaled $289.13 million at the end of June 30, 2019.