Aeglea Biotherapeutics, Inc. (AGLE) 10-K Annual Report February 2020

Company Expects to Complete Enrollment in Phase 3 Trial for Patients with Arginase 1 Deficiency in Third Quarter of 2020, with Topline Data Expected in First Quarter of 2021

Phase 1/2 Trial for Patients with Homocystinuria to Initiate in Second Quarter of 2020

Austin, Texas, February 24, 2020 -

Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing next-generation human enzyme therapeutics as solutions for diseases with high unmet medical need, today reported its fourth-quarter and full-year 2019 financial results, and provided recent corporate and program highlights.

“Our accomplishments this past year illustrate how we are working to reimagine the potential of human enzymes as transformative solutions for challenging rare genetic disorders,” said Anthony Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. “In addition to delivering compelling Phase 1/2 data from our lead program for Arginase 1 Deficiency, we’ve made solid progress with our pivotal trial enrollment and started laying the groundwork for the commercial launch. We have also continued to make significant progress in our pipeline, further demonstrating the effectiveness of our platform in advancing programs in multiple therapeutic areas.”

“We begin 2020 with a clear vision and heightened conviction of the impact for patients we can create with human enzyme therapeutics. We believe that we are well positioned to achieve a number of important milestones this year, armed with a strong leadership team with deep discovery, development and commercial expertise and driven by our collective goal to address the needs of the communities we serve,” concluded Dr Quinn.

Recent Highlights

Pegzilarginase in Arginase 1 Deficiency

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The Company expects to complete enrollment of its global, pivotal Phase 3 Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints (PEACE) trial in the third quarter of 2020 and to provide topline data in the first quarter of 2021.

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Based on a recent genetic prevalence analysis of Arginase 1 Deficiency (ARG1-D), and with more than 200 patients already identified worldwide, the Company now estimates an addressable patient population of greater than 2,500, up from an estimate of 1,000 patients based solely on initial insights using newborn screening data.

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The Company’s patient-identification strategy, informed by critical insights from disease analysis and trial experience, has already identified more than 100 patients in the United States, representing a 40% penetration into the genetic prevalent population.

ACN00177 in Homocystinuria

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In January, Aeglea announced the filing of its Clinical Trial Application (CTA) with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for ACN00177, a novel engineered human enzyme therapy designed to treat homocystinuria, a serious metabolic disorder that results in elevated levels of plasma homocysteine.

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The Company expects to initiate a Phase 1/2 trial for ACN00177 in the second quarter of 2020, with initial human proof of concept in the first quarter of 2021.

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The Company estimates an addressable homocystinuria patient population of greater than 5,000.

Upcoming Events

Aeglea will be attending the following investor conferences in the coming quarter. Details of the presentations and webcasts will be announced prior to the events.

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19th Annual Needham Healthcare Conference, April 14-15, New York City

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H.C. Wainwright 2020 Global Life Sciences Conference, April 20-21, London, United Kingdom

Further, Aeglea leadership looks forward to participating in dialogue about our enzyme therapeutics platform during the following industry events, with additional details forthcoming.

The following information was filed by Aeglea Biotherapeutics, Inc. (AGLE) on Monday, February 24, 2020 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 Aeglea Biotherapeutics, Inc.'s 10-K Annual Report:

Financial - Expense Highlight
The change in operating assets and liabilities of $7.2 million was primarily related to a $4.2 million increase in accrued and other liabilities due to additional research and development costs associated with the clinical trials for pegzilarginase in patients with Arginase 1 Deficiency and cancer, as well as a $3.1 million decrease in grants accounts receivable due to concluding the grant contract and collecting the remaining proceeds.

Revenue - Product Highlight
Additionally, we filed a new shelf registration statement on Form S-3 that was declared effective in February 2019 by the SEC for the potential offering, issuance and sale by us of up to $200.0 million, or the 2019 Registration Statement, of our common stock, preferred stock, debt securities, warrants to purchase common stock, preferred stock and debt securities, subscription rights to purchase common stock and units consisting of all or some of these securities.
Financial - Expense Highlight
The amendments in the update require an entity in a hosting arrangement that is a service contract to follow the guidance in Subtopic 350-40 to determine which implementation costs to capitalize as an asset related to the service contract and which costs to expense.
Other - Other Highlight
Our purpose-driven and patient focused approach to the selection and development of novel assets into clinical evaluation is guided by defined strategic considerations: - Clear, urgent unmet medical need - Rigorous preclinical data and strong scientific rationale - Mechanistic opportunity to create or enhance enzymatic activity through novel engineering - Meaningful and sustainable commercial opportunities - Potential to be first in class or best in class, with little competition Our lead product candidate, pegzilarginase, is engineered to degrade the amino acid arginine and is being developed to lower arginine levels in patients with Arginase 1 Deficiency, a rare genetic progressive disease, presenting in early childhood that results in severe complications and early mortality.
Financial - Expense Highlight
These increases will likely include higher costs related to the hiring of additional personnel and fees to outside consultants, lawyers and accountants, among other expenses.
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Our research and development expenses...Read more
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In August 2018, the FASB...Read more
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Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

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

Exhibit 4.5: Instruments Defining The Rights Of Security Holders, Including Indentures

Exhibit 21.1: Subsidaries Of The Registrant

Exhibit 23.1: Consents Of Experts And Counsel

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-K Annual Report
Accession Number: 0001564590-20-005888
Submitted to the SEC: Mon Feb 24 2020 7:34:23 AM EST
Accepted by the SEC: Mon Feb 24 2020
Period: Tuesday, December 31, 2019
Industry: Pharmaceutical Preparations

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Aeglea Biotherapeutics, Inc. (AGLE) SEC Filing 10-K Annual report for the fiscal year ending Tuesday, December 31, 2019

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