Aeglea BioTherapeutics Prepares for IPO

Aeglea BioTherapeutics has filed an amended S-1 form with the U.S. Securities and Exchange Commission (SEC) regarding its initial public offering (IPO). No pricing terms were given in the filing. The company intends to file on the Nasdaq Global Market under the symbol AGLE.

The underwriters for the offering are UBS Investment Bank, BMO Capital Markets and Wedbush PacGrow.

This biopharmaceutical company is committed to developing enzyme-based therapeutics in the field of amino acid metabolism that it believes will transform the lives of patients with inborn errors of metabolism and cancer. Its engineered human enzymes are designed to degrade specific amino acids in the blood. In inborn errors of metabolism (IEM), a subset of rare genetic metabolic diseases, Aeglea is seeking to reduce toxic levels of amino acids in patients. In oncology, it is seeking to reduce amino acid blood levels below the normal range, where the company believes it will be able to exploit the dependence of certain cancers on specific amino acids.
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The lead product candidate, AEB1102, is engineered to degrade the amino acid arginine and is being developed to treat two extremes of arginine metabolism, including arginine excess in patients with Arginase I deficiency, an IEM, as well as some cancers that have been shown to have a metabolic dependence on arginine. Arginine is an amino acid involved in many biochemical functions in the body. AEB1102 has demonstrated the ability to reduce blood arginine levels in nonclinical studies, supporting its potential use as a treatment of both Arginase I deficiency and cancer.

Aeglea has an accepted investigational new drug application (IND), with the U.S. Food and Drug Administration (FDA) for AEB1102 for the treatment of solid tumors. In the fourth quarter of 2015, the company initiated a Phase 1 dose escalation trial in patients with advanced solid tumors. In 2016, it plans to initiate expansion trials in patients with solid tumors and a Phase 1 dose escalation trial in patients with hematological malignancies. Also the company plans to initiate an additional Phase 1 trial in combination with standards of care in one or more solid tumor types in 2017.

In the filing the company said:

We are also building a pipeline of additional product candidates targeting key amino acids formed in or necessary for metabolism, or metabolites. These targets include the amino acid homocystine, a target for another IEM, as well as the amino acids cysteine/cystine and the amino acid methionine in oncology. Our current product candidates have been in-licensed from the University of Texas at Austin or assigned to us from one of our founders. We retain global commercialization rights for all of our product candidates.

The company intends to use the proceeds from this offering to further develop its pipeline, as well as for funding working capital and general corporate purposes.