OREANDA-NEWS. Aeglea BioTherapeutics, Inc., a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat inborn errors of metabolism and cancer, today reported financial results for the quarter ended March 31, 2016.

“The proceeds resulting from our April initial public offering will support our capital needs through the first quarter of 2018, allowing the Company to focus on clinical development activities of our lead product candidate AEB1102, in the rare disease Arginase I deficiency and in cancer, both of which are areas where we believe AEB1102 has the potential to transform the lives of these patients,” said David G. Lowe, PhD, co-founder, president and chief executive officer of Aeglea. “Our Phase 1 clinical trial with AEB1102 in patients with advanced solid tumors has provided clinical proof of mechanism on arginine depletion. We look to begin additional clinical trials for AEB1102 in mid-2016 in patients with either the hematological malignancy acute myelogenous leukemia (AML), or myelodysplastic syndrome (MDS), and separately, those with Arginase I deficiency, ultimately creating the opportunity to provide a clinical update in late 2016.” 

Recent Highlights

  • Completed an initial public offering (IPO) in April 2016 raising approximately $47.3 million in net proceeds.
  • Strengthened the leadership team in May 2016 with the appointment of Dr. Sandra Rojas-Caro to the position of chief medical officer.
  • Announced an effective investigational new drug application (IND) in January 2016 for AEB1102 in patients with Arginase I deficiency. Aeglea intends to initiate a Phase 1 dose escalation trial in effected patients in the first half of 2016.
  • Announced an effective IND in March 2016 for AEB1102 for the treatment of hematological malignancies in patients with relapsed and refractory AML and MDS. Aeglea intends to begin the Phase 1 dose escalation trial in the first half of 2016.

First Quarter 2016 Financial Results

At March 31, 2016, Aeglea had available cash, cash equivalents and marketable securities of $29.1 million, which does not include approximately $47.3 million in net proceeds from the April IPO. Management believes that Aeglea has sufficient capital resources to fund anticipated operations through the first quarter of 2018.

Grant revenue of $0.9 million was recognized in the first quarter of 2016 and is recorded as qualifying expenses are incurred. The grant revenue is the result of a $19.8 million research grant from the Cancer Prevention and Research Institute of Texas (CPRIT) that runs through May 31, 2017. There was no grant revenue in the first quarter of 2015, as the grant agreement was executed in the second quarter of 2015. 

Research and development expenses totaled $3.6 million for the first quarter of 2016, compared with $1.6 million for the first quarter of 2015. The increase was primarily associated with the increased nonclinical and clinical activity for Aeglea’s lead product candidate AEB1102, as Aeglea continued a Phase 1 dose escalation trial in patients with advanced solid tumors and prepared for Phase 1 clinical trials for AEB1102 in hematological malignancies and Arginase I deficiency. 

General and administrative expenses totaled $1.8 million for the first quarter of 2016, compared to $0.8 million in the first quarter of 2015. This increase was primarily due to increased employee compensation and the costs associated with preparing to be a public company.

Net loss totaled $4.5 million and $2.5 million for the first quarters 2016 and 2015, respectively.