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Aeglea Biotherapeutics, Inc. (AGLE) SEC Filing 10-Q Quarterly report for the period ending Monday, September 30, 2019

Aeglea Biotherapeutics, Inc.

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CIK: 1636282 Ticker: AGLE

Exhibit 99.1

 

Aeglea BioTherapeutics Reports Third Quarter 2019 Financial Results and Corporate Highlights

 

 

Austin, Texas, November 6, 2019 -

Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that engineers next-generation human enzymes to provide solutions for diseases with unmet medical need, today reported financial results for the third quarter ended September 30, 2019 and corporate highlights.

“We are excited about our pivotal Phase 3 PEACE trial in Arginase 1 Deficiency (ARG1-D), given the positive 20-dose data from our completed Phase 1/2 trial and ongoing Phase 2 open-label extension trial for pegzilarginase in patients with ARG1-D,” said Anthony G. Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. “Additionally, we are delighted to welcome Dr. Ravi Rao as chief medical officer and Mike Hanley as chief commercial officer, key executive leadership team additions who will help shape our future and continue the momentum of our ARG1-D, homocystinuria and cystinuria programs.”

Recent Highlights

 

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Aeglea presented positive 20-dose data on 14 patients from the Company’s completed Phase 1/2 trial and ongoing Phase 2 open-label extension (OLE) trial for pegzilarginase in patients with ARG1-D at the 2019 Symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM). All patients achieved a substantial reduction in plasma arginine with the median reduction of 274 µm from baseline to 20 doses. Aeglea reported 79% (11 of 14) of patients were clinical responders, using mobility assessment components that correspond with the PEACE trial’s secondary endpoint. Pegzilarginase was well tolerated and the rates of treatment-related adverse events decreased over time.

 

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Data from 10 patients dosed subcutaneously (sc) with pegzilarginase in the ongoing OLE trial for ARG1-D demonstrated that sc administration of pegzilarginase controls plasma arginine levels. All 10 patients remain on pegzilarginase sc with no patient discontinuations.

 

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Mike Hanley joined Aeglea as Chief Commercial Officer in October 2019. Mr. Hanley was previously Vice President and U.S. Chief Commercial Officer for Esteve Pharmaceuticals. He also served as Group Vice President and General Manager, Orphan Business Unit for Horizon Therapeutics. Mr. Hanley has 20 years of commercial leadership experience in the life sciences industry.

 

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Dr. Ravi Rao joined the Company as Chief Medical Officer in November 2019. Dr. Rao comes to Aeglea from GlaxoSmithKline, where he served as Vice President, Global Medical Affairs Head, Immunology and Specialty Franchise, leading programs across a number of emerging disease areas. Dr. Rao completed his residency training in London and is a Member of the Royal College of Physicians, London. He received his MB. BChir from Cambridge University and his Ph.D. in vascular biology from Imperial College, London in the United Kingdom and completed a postdoctoral fellowship at Harvard Medical School.


Upcoming Events

Aeglea will be attending the following investor conferences, with details regarding the date and time of the presentations and webcasts to be announced prior to the events.

 

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Jefferies 2019 London Healthcare Conference, November 20-21, London, UK

 

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Evercore ISI HealthCONx, December 3, Boston, MA

 

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Piper Jaffray Healthcare Conference, December 4-5, New York, NY

Aeglea will present a poster presentation titled “Impact of Enzymatic Degradation of Plasma Cystine in a Mouse Model of Cystinuria Under Dehydration Challenge” on Thursday, November 7th from 10:00 a.m. - 12:00 p.m. ET at the American Society of Nephrology Kidney Week annual meeting being held November 5 – 10 at the Walter E. Washington Convention Center in Washington, DC.

The Company expects to discuss the trial design for the AEB4104 program for homocystinuria during the investor conferences in the fourth quarter of 2019, prior to its filing of an IND or CTA in the first quarter of 2020.

Third Quarter 2019 Financial Results

As of September 30, 2019, Aeglea had available cash, cash equivalents, marketable securities and restricted cash of $90.2 million. Based on Aeglea’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations through the first quarter of 2021.

The following information was filed by Aeglea Biotherapeutics, Inc. (AGLE) on Wednesday, November 6, 2019 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 - 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)
Grant Revenues
Grant Revenues - Additional Information (Details)
Leases
Leases (Tables)
Leases - Additional Information (Details)
Leases - Schedule Of Maturities Of Operating And Finance Lease Liabilities (Details)
Leases - Schedule Of Operating And Financing Leases Presented In Balance Sheet (Details)
Leases - Summary Of Future Annual Minimum Lease Payments Due Under Non-Cancellable Operating Leases (Details)
Leases - Summary Of Weighted-Average Remaining Lease Term And Discount Rates For Operating And Finance Leases (Details)
License Agreements
License Agreements - Additional Information (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 Estimate Fair Value Of Stock Options Granted (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 Impact Of The Adoption Of Topic 842 (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

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification
Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification
Exhibit 32.1: Section 1350 Certification
Exhibit 32.2: Section 1350 Certification
Ticker: AGLE
CIK: 1636282
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-19-040692
Submitted to the SEC: Wed Nov 06 2019 3:34:37 AM EST
Accepted by the SEC: Wed Nov 06 2019
Period: Monday, September 30, 2019
Industry: Pharmaceutical Preparations

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