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Aeglea Biotherapeutics, Inc. (AGLE) SEC Filing 10-Q Quarterly Report for the period ending Thursday, September 30, 2021

Aeglea Biotherapeutics, Inc.

CIK: 1636282 Ticker: AGLE

Exhibit 99.1

Aeglea BioTherapeutics Reports Second Quarter 2021 Financial Results and Corporate Highlights

 

Initiated Dosing in Phase 1/2 Clinical Trial of AGLE-177 in Homocystinuria

 

Strengthened Leadership Team with Key Appointments, Including Jonathan Alspaugh as Chief Financial Officer

 

Austin, Texas, August 5, 2021 -

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 second quarter ended June 30, 2021, and reviewed recent corporate updates and program highlights.

 

“2021 is proving to be a pivotal year for Aeglea. In the second quarter, we achieved a significant milestone in our second clinical development program. With the initiation of dosing in our Phase 1/2 clinical trial of AGLE-177, Aeglea is making progress for patients who suffer from Homocystinuria, a rare and progressive disease which currently has limited treatment options,” said Anthony Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. “Additionally, with the strengthening of our leadership team, deepening relationship with the rare disease community and advancing our scientific communications platform, we continue to prepare for the data readout for our Phase 3 clinical trial of pegzilarginase in Arginase 1 Deficiency in the fourth quarter as well as lay the groundwork for potential approval and commercialization.”

 

Second Quarter and Recent Highlights and Updates

AGLE-177 in Homocystinuria

 

Initiated dosing with AGLE-177 in a Phase 1/2 clinical trial in people with Homocystinuria. The trial is anticipated to enroll 16–20 patients at sites located in the United Kingdom and Australia. Aeglea expects to provide a clinical update prior to the end of 2021.

 

Pegzilarginase in Arginase 1 Deficiency

 

Published 20-week data from a Phase 1/2 and open-label extension studies of pegzilarginase in the Journal of Inherited Metabolic Disease. The article, titled “Clinical Effect and Safety Profile of Pegzilarginase In Patients with Arginase 1 Deficiency,” is available in the July issue.

 

Corporate

 

Strengthened the leadership team with appointment of Jonathan Alspaugh as chief financial officer and Jim Kastenmayer as general counsel.

 

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Mr. Alspaugh joined Aeglea from Evercore, where he most recently served as a managing director in the firm's corporate advisory business.

 

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Mr. Kastenmayer joined Aeglea from Viela Bio, where he provided strategic guidance and legal advice, including advising Viela in connection with the FDA approval and launch of its first commercial product. 

 

Expanded the board of directors with the appointment of Marcio Souza. Mr. Souza serves as the president & chief executive officer of Praxis Precision Medicines.

 

Participated in Rare Disease Awareness Week on Capitol Hill 2021, meeting with patient advocates and law makers to raise awareness and discuss the specific needs facing the rare disease community.

 

Supported the launch of the Rare Disease Company Coalition, a unified voice of life science companies committed to discovering, developing and delivering rare disease treatments, of which Aeglea is a founding member.

 

Upcoming Investor Events

 

 

Wells Fargo 2021 Virtual Healthcare Conference, September 9–10

 

HC Wainwright 23rd Annual Global Investment Conference, September 13–15

 

2021 Cantor Virtual Healthcare Conference, September 27–30

 

Second Quarter 2021 Financial Results

 

As of June 30, 2021, Aeglea had available cash, cash equivalents, marketable securities and restricted cash of $130.4 million inclusive of the $21.5 million upfront cash payment received from Immedica Pharma AB pursuant to the March 2021 license and supply agreement. The Company expects its cash, cash equivalents and investments will enable it to fund its operating expenses and capital


The following information was filed by Aeglea Biotherapeutics, Inc. (AGLE) on Thursday, August 5, 2021 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 - Additional Information (Details)
Fair Value Measurements - Financial Assets And Liabilities Measured At Fair Value On Recurring Basis (Details)
License And Development Agreement
License And Development Agreement (Tables)
License And Development Agreement - Additional Information (Details)
License And Development Agreement - Summary Of Changes In Contract Liabilities (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)
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: 0001564590-21-054228
Submitted to the SEC: Thu Nov 04 2021 7:04:07 AM EST
Accepted by the SEC: Thu Nov 04 2021
Period: Thursday, September 30, 2021
Industry: Pharmaceutical Preparations

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