Aeglea BioTherapeutics Announces Update to Corporate Structure to Increase Operational Efficiency

Streamlining of organization to focus on near-term deliverables for pegtarviliase in Homocystinuria and long-term value creation

Cortney Caudill, M.B.A., has been promoted to the newly created role of chief product officer to increase focus and efficiency in the advancement of clinical programs

AUSTIN, Texas, Jan. 6, 2023 /PRNewswire/ -- 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 an update to its corporate structure. These changes are in addition to the restructuring process that was initiated in August 2022 and are intended to further streamline the organization, create operational efficiencies to support near- and long-term objectives and maximize the value of the company's two clinical programs.

As part of these additional changes, the workforce of the company has been further reduced by approximately 15%. Aeglea is also halting the preclinical work on the Cystinuria and other unnamed pipeline programs. The company will evaluate potential strategic options for these programs in order to maximize value.

In conjunction with these announcements, Cortney Caudill has been promoted from senior vice president of technical operations to chief product officer, effective January 6, 2023. In this expanded role, Ms. Caudill will be a strategic leader, team supervisor, and internal advocate for Aeglea's clinical programs, helping the company focus on key deliverables and resource allocation for both Homocystinuria and Arginase 1 Deficiency programs. In addition, Leslie Sloan, Ph.D., will be departing from her role as chief operating officer.

"Since joining as CEO, my focus has been on reviewing all aspects of the pipeline and determining the needs for achieving our short-term objectives and enabling long-term value creation. I believe the streamlining of the organization, the continued focus on pegtarviliase and the promotion of Cortney into a newly created product leadership role will help us achieve our goals in 2023 and set us up for future success," said Jeffrey Goldberg, president and chief executive officer of Aeglea. "This is a critical moment of change for the company. It is unfortunate that a group of talented and respected employees have been impacted. We value their important contributions to the company and are committed to provide support as they work through this transition. While this is a difficult decision, we believe it is in the best path to serving our most important stakeholder – the patients and their families."

Ms. Caudill joined Aeglea in 2019 and has served as a valued leader of the company's manufacturing, technical operations and pegtarviliase program teams. She has over 25 years of experience in the biotechnology and healthcare industry including leadership roles in manufacturing, site build and startup, quality, program management and business development. Prior to joining Aeglea, she was the head of Baxalta's Global Drug Product External Manufacturing Network and she was located in Zurich, Switzerland with responsibility for over 20 commercial and pipeline products. Ms. Caudill has held various roles of increasing responsibility at Cambrex, Vaxgen, Genentech, Vetter Pharma and Samsung Biologics, and started her career in the U.S. Air Force. She holds a B.S. in Biology and a B.A. in Psychology from The University of Texas as well as an M.B.A from Fordham University.

"I am excited to take on this new role as we continue to focus our efforts on enrolling the Homocystinuria trial for pegtarviliase and advancing pegzilarginase through the regulatory process," said Ms. Caudill. "I'm confident in the experience and knowledge of our teams and our ability to execute in delivering on the potential of these important programs for patients and their families."

About Pegtarviliase in Homocystinuria

Pegtarviliase is a novel recombinant human enzyme, which is engineered to degrade the amino acid homocysteine and its dimer. Pegtarviliase is currently being studied in a Phase 1/2 clinical trial for the treatment of patients with Classical Homocystinuria, a rare inherited disorder of methionine metabolism that results in elevated levels of total homocysteine. Homocysteine accumulation plays a key role in multiple progressive and serious disease-related complications, including thromboembolic vascular events, skeletal abnormalities (including severe osteoporosis), developmental delay, intellectual disability, lens dislocation and severe near sightedness. In preclinical studies, pegtarviliase improved important disease-related abnormalities and survival in a mouse model of Homocystinuria. Pegtarviliase has received both U.S. and EU Orphan Drug Designation as well as U.S. Rare Pediatric Disease Designation.

About Pegzilarginase in Arginase 1 Deficiency

Pegzilarginase is a novel recombinant human enzyme engineered to degrade the amino acid arginine and has been shown to rapidly and sustainably lower levels of the amino acid arginine in plasma. Aeglea is developing pegzilarginase for the treatment of people with Arginase 1 Deficiency (ARG1-D), a rare debilitating and progressive disease characterized by the accumulation of arginine. ARG1-D presents in early childhood and patients experience spasticity, seizures, developmental delay, intellectual disability and early mortality. The PEACE Phase 3 clinical trial met its primary endpoint with a 76.7% reduction in mean plasma arginine compared to placebo. Additionally, 90.5% of pegzilarginase treated patients achieved normal plasma arginine levels. The arginine lowering was accompanied by a positive trend in Gross Motor Function Measure Part E, a measure of patient mobility.

About Aeglea BioTherapeutics

Aeglea BioTherapeutics is a clinical-stage biotechnology company redefining the potential of human enzyme therapeutics to benefit people with rare metabolic diseases with limited treatment options. Aeglea is investigating pegtarviliase in an ongoing Phase 1/2 clinical trial for the treatment of Classical Homocystinuria. Pegtarviliase has been granted Rare Pediatric Disease Designation. Aeglea's other clinical program, pegzilarginase, achieved the primary endpoint of arginine reduction in the PEACE Phase 3 clinical trial and has received both Rare Pediatric Disease and Breakthrough Therapy Designations. The Marketing Authorization Application for pegzilarginase is currently under review with the European Medicines Agency. For more information, please visit https://aeglea.com.

Safe Harbor / Forward Looking Statements

This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, statements we make regarding our ability to achieve further cost-savings, the timing of announcements and updates relating to our clinical trials and related data, including the clinical data for our Phase 1/2 trial of pegtarviliase in Classical Homocystinuria, the timing and success of our clinical trials and related data, the timing and expectations for regulatory submissions and approvals, including the MAA for pegzilarginase in Europe, our ability to obtain regulatory approval for, and commercialize, pegzilarginase, recognize milestone and royalty payments from our agreement with Immedica, our ability to enroll patients into our clinical trials, the expected impact of the COVID-19 pandemic on our operations and clinical trials, success in our collaborations, the length of time that we believe our existing cash resources will fund operations, the potential addressable markets of our product candidates and the potential therapeutic benefits and economic value of our lead product candidate or other product candidates. Further information on potential risk factors that could affect our business and its financial results are detailed in our most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 filed with the Securities and Exchange Commission (SEC), and our other reports as filed with the SEC. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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SOURCE Aeglea BioTherapeutics, Inc.