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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.”

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.

Aeglea is a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat rare genetic diseases and cancer. The company’s engineered human enzymes are designed to modulate the extremes of amino acid metabolism in the blood to reduce toxic levels of amino acids in inborn errors of metabolism or target tumor metabolism for cancer treatment. AEB1102 (pegzilarginase), Aeglea’s lead product candidate, is currently being studied in two ongoing Phase 1 clinical trials in patients with advanced solid tumors and acute myeloid leukemia/myelodysplastic syndrome (AML/MDS). Additionally, Aeglea is recruiting patients into its ongoing Phase 1/2 trial of AEB1102 for the treatment of patients with Arginase 1 Deficiency. The company is building a pipeline of additional product candidates targeting key amino acids, including AEB4104, which degrades homocysteine and its oxidized form homocystine, a target for an inborn error of metabolism, as well as two potential treatments for cancer, AEB3103, which degrades cysteine, and its oxidized form cystine, and AEB2109, which degrades methionine. For more information, please visit http://aegleabio.com.

This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, statements we make regarding our cash forecasts, the timing and success of our clinical trials and related data, success in our collaborations and the potential therapeutic benefits and economic value of our lead product candidate or other product candidates. Further information on potential risk factors that could affect our business and its financial results are detailed in our most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 filed with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

	September 30,			December 31,
	2017			2016
ASSETS
CURRENT ASSETS
Cash and cash equivalents	$	13,162		$	47,748
Marketable securities		42,587			15,754
Accounts receivable - grant		2,452			1,215
Prepaid expenses and other current assets		1,318			1,707
Total current assets		59,519			66,424
Property and equipment, net		844			599
Other non-current assets		139			40
TOTAL ASSETS	$	60,502		$	67,063

LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable	$	615		$	168
Deferred revenue		50			71
Accrued and other current liabilities		4,212			3,726
Total current liabilities		4,877			3,965
Other non-current liabilities		117			132
TOTAL LIABILITIES		4,994			4,097

STOCKHOLDERS’ EQUITY
Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of September 30, 2017 and December 31, 2016; no shares issued and outstanding as of September 30, 2017 and December 31, 2016		—			—
Common stock, $0.0001 par value; 500,000,000 shares authorized as of September 30, 2017 and December 31, 2016; 16,472,831 shares and 13,430,833 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively		2			1
Additional paid-in capital		121,568			108,246
Accumulated other comprehensive loss		(32	)		(4	)
Accumulated deficit		(66,030	)		(45,277	)
TOTAL STOCKHOLDERS’ EQUITY		55,508			62,966
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	60,502		$	67,063

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2017			2016			2017			2016
Revenues:
Grant	$	1,261		$	1,149		$	3,723		$	3,381

Operating expenses:
Research and development		6,239			5,385			17,024			13,402
General and administrative		3,020			2,065			7,749			6,342
Total operating expenses		9,259			7,450			24,773			19,744
Loss from operations		(7,998	)		(6,301	)		(21,050	)		(16,363	)

Other income (expense):
Interest income		136			72			332			172
Other expense		(12	)		(9	)		(35	)		(24	)
Total other income		124			63			297			148
Net loss	$	(7,874	)	$	(6,238	)	$	(20,753	)	$	(16,215	)

Net loss per share, basic and diluted	$	(0.48	)	$	(0.47	)	$	(1.42	)	$	(1.89	)
Weighted-average common shares outstanding, basic and diluted		16,409,871			13,326,093			14,641,082			8,598,268