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Aeglea Biotherapeutics, Inc. (AGLE) SEC Filing 10-Q Quarterly report for the period ending Friday, March 31, 2017

Aeglea Biotherapeutics, Inc.

CIK: 1636282 Ticker: AGLE

Exhibit 99.1

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

Austin, Texas, May 9, 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 first quarter ended March 31, 2017.

“AEB1102 remains the primary focus of our clinical and preclinical work across rare genetic diseases and cancer,” said David G. Lowe, Ph.D., chief executive officer of Aeglea. “We are especially pleased with recent preclinical data which demonstrated that AEB1102 was not immunosuppressive in combination with anti-PD-1 immune checkpoint inhibitors. We believe this opens a unique opportunity at the intersection of tumor metabolism and existing or emerging therapies in immuno-oncology.”   

Recent Highlights

 

Presented preclinical data at the 2017 American Association of Cancer Research (AACR) Annual Meeting demonstrating that reducing systemic arginine with AEB1102 did not suppress the immune response induced by anti-PD-1 and anti-PD-L1, and exerted an additive anti-tumor and synergistic survival benefit.

 

Expanded research and development capabilities with the opening of an internal laboratory at Aeglea in Austin, TX.

Upcoming Events

 

David G. Lowe, Ph.D., chief executive officer of Aeglea, will present a corporate update at the UBS 2017 Global Healthcare Conference being held May 22 – 24, 2017 in New York City.

First Quarter 2017 Financial Results

At March 31, 2017, Aeglea had available cash, cash equivalents and marketable securities of $57.9 million. Based on Aeglea’s current operating plan, management believes that it has sufficient capital resources to fund anticipated operations through March 31, 2019.

Aeglea recognized grant revenues of $1.0 million in the first quarter of 2017, compared with $0.9 million in the first 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 higher qualifying expenditures associated with AEB1102 for grant-related clinical trials.

Research and development expenses totaled $4.9 million for the first quarter of 2017, compared with $3.6 million for the first quarter of 2016. The increase was primarily associated with hiring additional personnel to expand Aeglea’s internal regulatory, laboratory, and clinical development capabilities.  

General and administrative expenses totaled $2.3 million for the first quarter of 2017, compared to $1.8 million in the first quarter of 2016. This increase was primarily due to additional compensation and personnel costs, and increased costs associated with operating as a public company.

Net loss totaled $6.2 million and $4.5 million for the first quarter of 2017 and 2016, respectively.

About Aeglea BioTherapeutics

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, 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 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.

Safe Harbor / Forward Looking Statements

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


The following information was filed by Aeglea Biotherapeutics, Inc. (AGLE) on Tuesday, May 9, 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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Document And Entity Information
Condensed Consolidated Balance Sheets (unaudited)
Condensed Consolidated Balance Sheets (unaudited) (parenthetical)
Condensed Consolidated Statements Of Cash Flows (unaudited)
Condensed Consolidated Statements Of Comprehensive Loss (unaudited)
Condensed Consolidated Statements Of Operations (unaudited)
Accrued And Other Current Liabilities
Accrued And Other Current Liabilities (details)
Accrued And Other Current Liabilities (tables)
Cash Equivalents And Marketable Securities
Cash Equivalents And Marketable Securities (tables)
Cash Equivalents And Marketable Securities - Additional Information (details)
Cash Equivalents And Marketable Securities - Schedule Of Estimated Fair Value Of Cash Equivalents And Marketable Securities (details)
Cash Equivalents And Marketable Securities - Summary Of Contractual Maturities Of Marketable Securities At Estimated Fair Value (details)
Commitments And Contingencies
Commitments And Contingencies (tables)
Commitments And Contingencies - Additional Information (details)
Commitments And Contingencies - Summary Of Future Minimum Commitments For Operating Leases (details)
Fair Value Measurement (tables)
Fair Value Measurements
Fair Value Measurements - Additional Information (details)
Fair Value Measurements - Financial Assets And Liabilities Measured At Fair Value On Recurring Basis (details)
Grant Revenues
Grant Revenues - Additional Information (details)
Net Loss Per Share Attributable To Common Stockholders
Net Loss Per Share Attributable To Common Stockholders (tables)
Net Loss Per Share Attributable To Common Stockholders - Weighted-average Equity Instruments Excluded From Calculation Of Diluted Net Loss Per Share (details)
Related Party Transactions
Related Party Transactions - Additional Information (details)
Research And License Agreements
Research And License Agreements - Additional Information (detail)
Stock-based Compensation
Stock-based Compensation (tables)
Stock-based Compensation - Additional Information (details)
Stock-based Compensation - Schedule Of Estimate Fair Value Of Stock Options Granted (details)
Stock-based Compensation - Summary Of Stock-based Compensation Expense (details)
Subsequent Events
Subsequent Events - Additional Information (details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (policies)
Summary Of Significant Accounting Policies (tables)
Summary Of Significant Accounting Policies - Additional Information (details)
Summary Of Significant Accounting Policies - Summary Of Useful Lives Of Property And Equipment (details)
The Company And Basis Of Presentation
The Company And Basis Of Presentation - Additional Information (details)
Ticker: AGLE
CIK: 1636282
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-17-009615
Submitted to the SEC: Tue May 09 2017 8:02:55 AM EST
Accepted by the SEC: Tue May 09 2017
Period: Friday, March 31, 2017
Industry: Pharmaceutical Preparations

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