Exhibit 99.1

Aeglea BioTherapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2016 Financial Results

-- Topline Results Presented Today of Phase 1 Open-Label Study of AEB1102 Enzyme Replacement Therapy in Adult Patients with Arginase I Deficiency --

 

-- Conference Call Today at 4:30 p.m. ET to Provide Corporate Update and Review Arginase I Deficiency Clinical Results --

Austin, Texas, March 23, 2017 -

Aeglea BioTherapeutics, Inc., (NASDAQ: AGLE) a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat rare genetic diseases and cancer, today provided a corporate update and reported financial results for the fiscal fourth quarter and year ended December 31, 2016.

“In 2016, Aeglea made significant progress advancing our AEB1102 program, including encouraging data from our Phase 1 clinical trial in Arginase I deficiency showing that treatment with AEB1102 was well tolerated and effective at reducing levels of arginine in blood. We also advanced our oncology programs, continuing our dose escalation studies in both solid tumors and hematological malignancies as well as presenting preclinical studies that lay the foundation for a possible combination strategy of AEB1102 with immune checkpoint inhibitors,” said David G. Lowe, Ph.D., chief executive officer of Aeglea. “We believe we are well positioned to carry this momentum into 2017. We look forward to continuing to advance our Arginase I deficiency program with today’s topline data presentation at the American College of Medical Genetics and Genomics Annual Clinical Genetics Meeting and the recent protocol amendment which expands our clinical trial from a Phase 1 to a Phase 1/2.”   

Recent Highlights

 

Presented topline data from the Phase 1 clinical trial of AEB1102 in two adult patients with Arginase I deficiency at the 2017 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting on March 23, demonstrating that AEB1102 was well tolerated and effective at reducing arginine levels in the blood of both patients. Treatment with AEB1102 resulted in a dose-proportional decrease in plasma arginine levels of between 25 and 49 percent of pre-dose levels one week after dosing.

 

Amended Arginase I deficiency protocol to a Phase 1/2 clinical trial of AEB1102, which will provide the opportunity to complete weekly repeat dosing (for up to eight weeks) in up to 10 patients.  

 

Enrolling cohort 8 at 0.40 mg/kg in Phase 1 clinical trial of AEB1102 for the treatment of patients with advanced solid tumors.

 

Enrolling cohort 3 at 0.48 mg/kg in Phase 1 clinical trial of AEB1102 for the treatment of patients with the hematological malignancies acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

 

Presented preclinical studies that demonstrated arginine depletion with AEB1102 enhances efficacy when used in combination with immune checkpoint inhibitors.

 

Research data on newborn screening protocols demonstrated that Arginase I deficiency can be screened with very high efficiency, which underscores the company’s belief that it is a potential candidate for future addition to the neonatal Recommended Uniform Screening Panel (RUSP). Additional data will be presented at the ACMG Annual Clinical Genetics Meeting on March 24, 2017.

 

Strengthened the leadership team in February 2017 with the appointment of Suzanne L. Bruhn, Ph.D. to the Board of Directors.

Fourth Quarter and Full Year 2016 Financial Results

At December 31, 2016, Aeglea had available cash, cash equivalents and marketable securities of $63.5 million. Based on Aeglea’s current operating plan, management believes that it has sufficient capital resources to fund anticipated operations through the first quarter of 2019.

Aeglea recognized grant revenues of $1.2 million in the fourth quarter of 2016, compared with $1.6 million in the fourth quarter of 2015. The grant revenues are the result of a $19.8 million research grant received from the Cancer Prevention and Research Institute of Texas (CPRIT). The decrease was primarily due to lower qualifying expenditures associated with AEB1102 for grant-related clinical trials.

Grant revenues of $4.6 million were recognized in the year ended December 31, 2016 compared with $6.1 million in the year ended December 31, 2015. The decrease was primarily due to grant revenues recognized in connection with the execution of the CPRIT grant agreement in June 2015. Upon execution of the agreement, all accumulated qualified expenditures paid and incurred during the


The following information was filed by Aeglea Biotherapeutics, Inc. (AGLE) on Thursday, March 23, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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