Exhibit 99.1

Aeglea BioTherapeutics Provides Corporate Update and Reports Third Quarter 2017 Financial Results

Austin, Texas, November 7, 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 third quarter ended September 30, 2017.

“I am very pleased with the forward momentum and progress of the team at Aeglea over the last few months. Initiation of repeat dosing in Part 2 of our Phase 1/2 clinical trial for the treatment of Arginase 1 Deficiency is an important milestone and we look forward to the first insights on the effects of longer term dosing with AEB1102 in adults with Arginase 1 Deficiency,” said Anthony Quinn, M.B Ch.B, Ph.D., interim chief executive officer of Aeglea. “Additionally, our clinical collaboration with Merck on the effects of AEB1102 in combination with pembrolizumab in small cell lung cancer allows us to accelerate our profiling of the anti-cancer activity of AEB1102 beyond monotherapy in cancers with characteristics suggestive of arginine dependence.”    

Corporate Update

Arginase 1 Deficiency:

 

Dosed two adults in Part 2 (repeat dose) of our Phase 1/2 clinical trial of AEB1102 (pegzilarginase), which is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of weekly treatment in patients with Arginase 1 Deficiency

 

Initiated site selection and regulatory activities in Europe and site readiness in Canada to support our ex-US strategy for completion of the Phase 1/2 clinical trial

 

Continued dialogue with FDA about the inclusion of pediatric patients in the Phase 1/2 clinical trial

Cancer:

 

Announced a clinical collaboration to evaluate the combination of AEB1102 with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for the treatment of patients with small cell lung cancer. The multicenter Phase 1/2 trial will evaluate objective response rates in patients with extensive small cell lung cancer who have relapsed or progressed after receiving platinum-based chemotherapy. Enrollment is expected to begin in the first quarter of 2018.

Upcoming Events

 

Aeglea will deliver a poster presentation describing the effects of combining AEB1102 with anti-PD-L1 in a preclinical tumor model at the 2017 Society for Immunotherapy of Cancer Annual Meeting taking place November 8 – 12 in National Harbor, Maryland

 

Aeglea will present a corporate update at the BMO Capital Markets 2017 Prescription for Success Healthcare Conference on December 14 in New York

Third Quarter 2017 Financial Results

On September 30, 2017, Aeglea had available cash, cash equivalents and marketable securities of $55.7 million. Based on Aeglea’s current operating plan, management believes that it has sufficient capital resources to fund anticipated operations through the third quarter of 2019.

Aeglea recognized grant revenues of $1.3 million in the third quarter of 2017, compared with $1.2 million in the third quarter of 2016. 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 increase was primarily due to additional qualifying expenditures associated with the clinical trials for AEB1102 in patients with advanced solid tumors and the hematological malignancies acute myeloid leukemia and myelodysplastic syndrome.

Research and development expenses totaled $6.2 million for the third quarter of 2017, compared with $5.4 million for the third quarter of 2016. The increase was primarily associated with hiring additional personnel to expand Aeglea’s internal regulatory, laboratory, and clinical development capabilities, as well as manufacturing activities for AEB1102 and other pipeline programs.  

General and administrative expenses totaled $3.0 million for the third quarter of 2017, compared with $2.1 million for the third quarter of 2016. The increase was primarily due to an increase in employee compensation and facilities costs.

Net loss totaled $7.9 million and $6.2 million for the third quarter of 2017 and 2016, respectively.

About Aeglea BioTherapeutics


The following information was filed by Aeglea Biotherapeutics, Inc. (AGLE) on Tuesday, November 7, 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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