Aeglea Biotherapeutics, Inc. (AGLE) SEC Filing 10-Q Quarterly Report for the period ending Friday, September 30, 2022

Aeglea Biotherapeutics, Inc.

CIK: 1636282 Ticker: AGLE

Exhibit 99.1


Aeglea BioTherapeutics Reports Third Quarter 2022 Financial Results and Provides Program Updates


Interim Clinical Data from Phase 1/2 Trial of Pegtarviliase Expected in Fourth Quarter of 2022; Currently Dosing Cohort 3 at 1.35 mg/kg


MAA for Pegzilarginase for the Treatment of Arginase 1 Deficiency Accepted for Review by the EMA


$75.2 Million of Cash as of September 30, 2022; Runway into Fourth Quarter of 2023


Austin, Texas, November 3, 2022 - Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced financial results for the third quarter ended September 30, 2022 and provided program updates.


“With our recent corporate restructuring we have prioritized our pegtarviliase program to optimize our resources and maximize Aeglea’s success. We continue to advance our Phase 1/2 trial of pegtarviliase for Classical Homocystinuria with the ongoing enrollment of cohort 3 and look forward to sharing interim data from this trial before the end of the year,” said Jim Kastenmayer, Ph. D., J.D., interim chief executive officer and general counsel of Aeglea. “While our primary focus is pegtarviliase, we are a multi-program company and are pleased that the Marketing Authorization Application for pegzilarginase for Arginase 1 Deficiency submitted by our valued partner Immedica is currently under review by the EMA for a potential approval next year. We view the progress in our portfolio as validation of what can be accomplished through our innovative human enzyme engineering platform and its potential to transform the lives of patients and families living with rare metabolic diseases.”


Program and Corporate Updates


Pegtarviliase in Homocystinuria

Currently dosing Classical Homocystinuria patients in cohort 3 at 1.35 mg/kg once weekly via subcutaneous injection in the Phase 1/2 clinical trial.
Plan to announce interim Phase 1/2 clinical data, including data from cohort 3, in the fourth quarter of 2022.
Received a letter from the U.S. Food and Drug Administration (FDA) responding to a protocol amendment stating that patients aged younger than 18 years cannot currently be enrolled in the Phase 1/2 trial. The company believes the letter will have no impact on the timeline for the trial.
Hosted a Key Opinion Leader (KOL) webinar discussing Classical Homocystinuria and providing an overview of the pegtarviliase program.


Pegzilarginase in Arginase 1 Deficiency

Marketing Authorization Application (MAA) was submitted by Immedica, Aeglea’s commercialization partner in Europe and certain countries in the Middle East, and validated by the European Medicines Agency (EMA). The MAA is currently under review by the EMA.
Actively engaged with the FDA to identify a viable regulatory approach and path to the resubmission of the Biologics License Application (BLA).
Presented efficacy and safety data from the PEACE Phase 3 clinical trial at the Society for the Study of Inborn
Errors of Metabolism (SSIEM).


The following information was filed by Aeglea Biotherapeutics, Inc. (AGLE) on Thursday, November 3, 2022 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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Inside Aeglea Biotherapeutics, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

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 Changes In Stockholders' Equity (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 - Schedule Of Gross Unrealized Losses And Fair Value By Investment Category And Age (Details)
Cash Equivalents And Marketable Securities - Summary Of Contractual Maturities Of Marketable Securities At Estimated Fair Value (Details)
Fair Value Measurement (Tables)
Fair Value Measurements
Fair Value Measurements - Financial Assets And Liabilities Measured At Fair Value On Recurring Basis (Details)
Net Loss Per Share
Net Loss Per Share (Tables)
Net Loss Per Share - Weighted-Average Equity Instruments Excluded From Calculation Of Diluted Net Loss Per Share (Details)
Stockholders' Equity
Stockholders' Equity (Tables)
Stockholders' Equity - Additional Information (Details)
Stockholders' Equity - Schedule Of Company's Stock Awards Granted (Details)
Stockholders' Equity - Schedule Of Estimate Fair Value Of Stock Options Granted (Details)
Stockholders' Equity - Summary Of Pre-Funded Warrants For Common Stock Issued And Outstanding (Details)
Stockholders' Equity - Summary Of Stock-Based Compensation Expense (Details)
Strategic License Agreements
Strategic License Agreements (Tables)
Strategic License Agreements - Additional Information (Details)
Strategic License Agreements - Summary Of Changes In Contract Liabilities (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
The Company And Basis Of Presentation
The Company And Basis Of Presentation - Additional Information (Details)

Material Contracts, Statements, Certifications & more

Aeglea Biotherapeutics, Inc. provided additional information to their SEC Filing as exhibits

Ticker: AGLE
CIK: 1636282
Form Type: 10-Q Quarterly Report
Accession Number: 0000950170-22-021529
Submitted to the SEC: Thu Nov 03 2022 7:05:08 AM EST
Accepted by the SEC: Thu Nov 03 2022
Period: Friday, September 30, 2022
Industry: Pharmaceutical Preparations

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