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Aeglea Biotherapeutics, Inc. (AGLE) SEC Filing 10-K Annual report for the fiscal year ending Saturday, December 31, 2016

Aeglea Biotherapeutics, Inc.

CIK: 1636282 Ticker: AGLE

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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Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Changes In Convertible Preferred Shares/stock And Members'/stockholders' Equity (deficit)
Consolidated Statements Of Changes In Convertible Preferred Shares/stock And Members'/stockholders' Equity (deficit) (parenthetical)
Consolidated Statements Of Comprehensive Loss
Consolidated Statements Of Operations
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)
Commitments And Contingencies
Commitments And Contingencies (tables)
Commitments And Contingencies - Additional Information (details)
Commitments And Contingencies - Summary Of Future Annual Minimum Lease Payments Due Under Non-cancellable Operating Leases (details)
Common Stock
Common Stock - Additional Information (details)
Convertible Preferred Stock
Convertible Preferred Stock (tables)
Convertible Preferred Stock - Additional Information (details)
Convertible Preferred Stock - Schedule Of Convertible Preferred Stock (details)
Defined Contribution Plan
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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)
Income Taxes
Income Taxes (tables)
Income Taxes - Additional Information (details)
Income Taxes - Components Of Deferred Tax Assets And Liabilities (details)
Income Taxes - Difference Between Provision For Income Taxes And Amounts Computed By Applying Statutory Federal Income Tax Rate To Income Before Income Taxes (details)
Net Loss Per Share Attributable To Common Shareholders And Stockholders
Net Loss Per Share Attributable To Common Shareholders And Stockholders (tables)
Net Loss Per Share Attributable To Common Shareholders And Stockholders - Weighted-average Equity Instruments Excluded From Calculation Of Diluted Net Loss Per Share (details)
Property And Equipment, Net
Property And Equipment, Net (tables)
Property And Equipment, Net - Additional Information (details)
Property And Equipment, Net - Schedule Of Property And Equipment Net (details)
Related Party Transactions
Related Party Transactions - Additional Information (details)
Research And License Agreements
Research And License Agreements - Additional Information (detail)
Selected Quarterly Financial Data (unaudited)
Selected Quarterly Financial Data (unaudited) (tables)
Selected Quarterly Financial Data (unaudited) - Schedule Of Selected Quarterly Results From Operations (details)
Share/stock-based Compensation
Share/stock-based Compensation (tables)
Share/stock-based Compensation - Additional Information (details)
Share/stock-based Compensation - Summary Of Employee And Non-employee Restricted Stock Activity (details)
Share/stock-based Compensation - Summary Of Employee And Nonemployee Stock Option Activity (details)
Share/stock-based Compensation - Summary Of Share/stock-based Compensation Expense (details)
Share/stock-based Compensation - Summary Of Weighted-average Assumptions Used In Calculating Fair Value Of Awards (details)
Subsequent Events
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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-K Annual Report
Accession Number: 0001564590-17-005137
Submitted to the SEC: Thu Mar 23 2017 4:07:59 PM EST
Accepted by the SEC: Thu Mar 23 2017
Period: Saturday, December 31, 2016
Industry: Pharmaceutical Preparations

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