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Aeglea Biotherapeutics, Inc. (AGLE) SEC Filing 10-Q Quarterly Report for the period ending Thursday, March 31, 2022

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AGLE Quarterly Reports

Aeglea Biotherapeutics, Inc.

CIK: 1636282 Ticker: AGLE

Exhibit 99.1

Aeglea BioTherapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Program Updates

 

Pegzilarginase BLA preparation on track to enable a second quarter 2022 submission to the FDA

 

Accelerating Phase 1/2 trial of AGLE-177 for Homocystinuria; clinical data announcement expected in the second half of 2022

 

$95 million of cash as of December 31, 2021, which is expected to fund operations into the first quarter of 2023

 

 

Austin, Texas, March 8, 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 fourth quarter and full year 2021, and provided program updates.

 

“2021 moved us closer to our goal of delivering life-changing medicines to people with rare metabolic diseases with positive topline data from our pivotal Phase 3 trial of pegzilarginase for Arginase 1 Deficiency and the dosing of the first patients in our Phase 1/2 trial of AGLE-177 for Homocystinuria. We enter 2022 well positioned to capitalize on the momentum we’ve built,” said Anthony Quinn, M.B., Ch.B., Ph. D., president and chief executive officer of Aeglea. “We are excited about the opportunities in 2022 for a transformative year. With a strong portfolio of human enzyme therapies for rare metabolic diseases, we are looking forward to advancing all our programs, including sharing clinical data from our AGLE-177 program, progressing AGLE-325 for Cystinuria through IND-enabling studies and working with the FDA throughout the regulatory process for pegzilarginase.”

 

Program Updates

 

Pegzilarginase in Arginase 1 Deficiency

 

Announced the PEACE Phase 3 clinical trial met its primary endpoint with an 80% plasma arginine reduction, and an accompanying positive trend in a secondary endpoint assessing mobility. Additionally, 90.5% of patients achieved normal plasma arginine levels. Pegzilarginase was well-tolerated, and no patients discontinued the trial due to adverse events.

 

Highlighted 104-week data from the GMFM-E and 6-Minute Walk Test assessments from the Phase 1/2 open-label extension, which underscores the sustained, long-term impact of pegzilarginase treatment on mobility.

 

Plan to present additional data from PEACE Phase 3 clinical trial at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting in April 2022.

 

Hosted a Key Opinion Leader and Patient Caregiver event to provide insights and perspectives on treating and living with Arginase 1 Deficiency.

 

Met with U.S. Food and Drug Administration (FDA) in late February to discuss data from the pegzilarginase program and the path towards Biologic License Application (BLA) submission.

 

BLA preparation on track to enable a second quarter 2022 submission.

 

AGLE-177 in Homocystinuria

 

Completed dosing in the 0.15 mg/kg intravenous cohort in the Phase 1/2 clinical trial. AGLE-177 was well tolerated with no safety concerns and data from this first cohort showed reductions in total homocysteine in all patients.

 

The encouraging results from the first cohort allowed the Company to advance directly to the 0.45 mg/kg subcutaneous dose, accelerating the generation of dose response data. This second cohort is currently being dosed.

 

Filed an Investigational New Drug (IND) application with the FDA. Acceptance of the IND would allow the Company to open clinical trial sites in the U.S. for the Phase 1/2 clinical trial and a potential pivotal Phase 3 trial.

 

Expect to announce Phase 1/2 clinical data in the second half of 2022.

 

AGLE-325 in Cystinuria


The following information was filed by Aeglea Biotherapeutics, Inc. (AGLE) on Tuesday, March 8, 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)
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)

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: 0001564590-22-018006
Submitted to the SEC: Thu May 05 2022 6:40:52 AM EST
Accepted by the SEC: Thu May 05 2022
Period: Thursday, March 31, 2022
Industry: Pharmaceutical Preparations

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