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Aeglea BioTherapeutics Inc

Announcement: AGLE 8-K Special Filing

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Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Announcement: AGLE 10-Q Quarterly Report

Aeglea BioTherapeutics reported its first quarter 2023 financial results, which showed the company had cash and cash equivalents, marketable securities, and restricted cash of $39.8 million as of March 31, 2023. The company recognized development fee and royalty revenues of $0.2 million, compared to $1.4 million in the same period last year. The decrease in revenues was primarily related to a decrease in activities related to the PEACE Phase 3 trial and Biologics License Application for pegzilarginase. The company's research and development expenses decreased to $13.8 million from the previous year's $17.0 million. Similarly, Aeglea's general and administrative expenses decreased to $5.2 million from the previous year's $8.8 million. The company reported a net loss of $18.4 million, compared to a net loss of $24.4 million during the same period last year. 

Aeglea BioTherapeutics is a clinical-stage biotechnology company that specializes in developing human enzyme therapeutics for treating rare metabolic diseases with limited treatment options. The company's primary clinical program is focused on pegzilarginase, which has achieved the primary endpoint of arginine reduction in the PEACE Phase 3 clinical trial. The Marketing Authorization Application for pegzilarginase is currently under review with the European Medicines Agency. The company has also developed a pipeline of engineered human enzymes that have been explored in preclinical testing, the most advanced of which is for the potential treatment of Cystinuria. 

Given the company's focus on rare metabolic diseases and promising clinical programs, its financial report is encouraging, despite a decrease in revenues recorded in the first quarter of 2023. However, investors should be mindful of the risks and uncertainties outlined in the company's Safe Harbor/Forward Looking Statements section, which notes that actual results may differ materially from what the company expects due to numerous risks and uncertainties.

Form 8-K - Current report - Item 2.02 Item 9.01

$AGLE Reports Q1 2023 Financial Results with $39.8 Million in Cash and Promising Clinical Programs

Form 8-K - Current report - Item 2.02 Item 7.01 Item 9.01

Form 8-K - Current report - Item 2.05 Item 5.02 Item 8.01 Item 9.01