PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements) Aeglea BioTherapeutics reported a **$18.4 million** net loss for Q1 2023, total assets at **$52.5 million**, and a 'going concern' warning [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$52.5 million** from **$71.1 million** at year-end 2022, driven by reduced marketable securities and cash used in operations Condensed Consolidated Balance Sheet Highlights | Balance Sheet Item | March 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $35,243 | $34,863 | | Marketable securities | $3,235 | $20,848 | | Total current assets | $44,375 | $62,258 | | **Total Assets** | **$52,453** | **$71,144** | | **Liabilities & Equity** | | | | Total current liabilities | $12,637 | $14,656 | | **Total Liabilities** | **$18,801** | **$20,839** | | **Total Stockholders' Equity** | **$33,652** | **$50,305** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2023 revenue decreased to **$0.2 million**, operating expenses fell to **$19.0 million**, narrowing the net loss to **$18.4 million** from **$24.4 million** year-over-year Condensed Consolidated Statements of Operations | Line Item | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :--- | :--- | :--- | | Total revenue | $198 | $1,362 | | Research and development | $13,776 | $16,978 | | General and administrative | $5,228 | $8,825 | | Total operating expenses | $19,004 | $25,803 | | Loss from operations | ($18,806) | ($24,441) | | **Net loss** | **($18,422)** | **($24,436)** | | Net loss per share, basic and diluted | ($0.20) | ($0.37) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations decreased to **$17.6 million**, with **$17.8 million** provided by investing activities, ending the quarter with **$36.6 million** in cash and equivalents Cash Flow Summary | Cash Flow Activity | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($17,634) | ($26,263) | | Net cash provided by investing activities | $17,750 | $25,759 | | Net cash provided by financing activities | $10 | $12 | | **Net increase (decrease) in cash** | **$137** | **($515)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's strategic alternatives, **83%** workforce reduction, 'going concern' doubt, Immedica agreement, and pre-funded warrants - The company has substantial doubt about its ability to continue as a going concern within one year, citing its accumulated deficit of **$444.0 million** and the need for additional financing[30](index=30&type=chunk)[33](index=33&type=chunk) - In April 2023, the company initiated a process to explore strategic alternatives and approved a restructuring plan to reduce its workforce by approximately **83%**[29](index=29&type=chunk)[32](index=32&type=chunk) - As of March 31, 2023, the company had **28,891,578** pre-funded warrants outstanding, each with an exercise price of **$0.0001**[47](index=47&type=chunk) - Subsequent to the quarter end, the company announced a restructuring plan estimated to incur **$6.2 million** in charges, primarily related to employee severance, with the majority expected in Q2 2023[67](index=67&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the shift to strategic alternatives, **83%** workforce reduction, paused clinical programs, reduced operating expenses, and reiterates 'going concern' doubt [Overview and Recent Developments](index=17&type=section&id=Overview%20and%20Recent%20Developments) Aeglea is exploring strategic alternatives and implemented an **83%** workforce reduction and clinical trial pause after inconclusive pegtarviliase results - The company's current focus is to explore strategic alternatives, including possible business combinations or divestiture of its clinical programs, to maximize stockholder value[71](index=71&type=chunk)[74](index=74&type=chunk) - In April 2023, the company initiated a restructuring plan, reducing its workforce by approximately **83%** to about **10** employees to support the evaluation of strategic alternatives[74](index=74&type=chunk)[84](index=84&type=chunk) [Pipeline of Product Candidates](index=19&type=section&id=Pipeline%20of%20Product%20Candidates) Clinical development is paused; pegtarviliase showed inconclusive results, while pegzilarginase faces an FDA Refusal to File despite EMA review - Interim results from the Phase 1/2 trial of pegtarviliase showed that participants in the third cohort (**1.35 mg/kg**) developed anti-drug antibodies, which may have reduced the drug's effect. Clinical development for this program is paused[86](index=86&type=chunk) - The FDA has placed the pegtarviliase trial on a partial clinical hold for the enrollment of patients under **18** years of age in the U.S., citing a lack of evidence for direct clinical benefit in pediatric patients[89](index=89&type=chunk) - The EMA validated the MAA for pegzilarginase, with a potential decision in late 2023. However, the FDA issued a Refusal to File (RTF) letter for the BLA, requesting additional data to support effectiveness[94](index=94&type=chunk)[95](index=95&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Q1 2023 revenue decreased to **$0.2 million**, while R&D and G&A expenses fell by **19%** and **41%** respectively, leading to a net loss of **$18.4 million** Comparison of Results of Operations | Line Item | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :--- | :--- | :--- | | Total revenue | $198 | $1,362 | | Research and development | $13,776 | $16,978 | | General and administrative | $5,228 | $8,825 | | **Net loss** | **($18,422)** | **($24,436)** | - R&D expenses decreased by **$3.2 million (19%)** primarily due to reduced costs for the pegzilarginase PEACE Phase 3 trial and BLA submission activities[106](index=106&type=chunk) - G&A expenses decreased by **$3.6 million (41%)** due to lower headcount, reduced commercial expenses for Arginase 1 Deficiency, and decreased general support activities[106](index=106&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces substantial doubt about its 'going concern' ability, with an accumulated deficit of **$444.0 million**, and is focused on a strategic transaction while minimizing expenditures - The company has determined there is substantial doubt about its ability to continue as a going concern within twelve months of the financial statement issuance date[82](index=82&type=chunk)[116](index=116&type=chunk) - The company's operational plan is to identify, assess, and execute a strategic transaction while reducing R&D and G&A expenditures[114](index=114&type=chunk) - As of March 31, 2023, the company had an accumulated deficit of **$444.0 million**[81](index=81&type=chunk)[114](index=114&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risk is interest rate sensitivity on short-term marketable securities, deemed immaterial, with minimal foreign currency exchange rate risk - The company's primary market risk is interest rate sensitivity on its marketable securities, but this exposure is not considered significant due to the short-term duration and low-risk profile of the investments[127](index=127&type=chunk) - Foreign currency exchange rate risk is minimal as most transactions are denominated in U.S. dollars[129](index=129&type=chunk) [Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of March 31, 2023, with no material changes to internal control over financial reporting - As of March 31, 2023, the company's principal executive officer and principal financial officer concluded that disclosure controls and procedures were effective[130](index=130&type=chunk) - No material changes were made to the company's internal control over financial reporting during the quarter ended March 31, 2023[131](index=131&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its financial condition or operations - Management believes there are currently no pending claims or actions that would have a material adverse effect on the company's results of operations, financial condition, or cash flows[133](index=133&type=chunk) [Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) New risks relate to strategic alternatives, including transaction failure, low asset valuation, 'going concern' doubt, restructuring impacts, and dependence on paused clinical programs [Risks Related to Strategic Alternative Process](index=27&type=section&id=Risks%20Related%20to%20Strategic%20Alternative%20Process) Risks include failure to complete a strategic transaction, potential dissolution and liquidation, and low valuation of assets by counterparties - There is no assurance that the exploration of strategic alternatives will result in a transaction. If one is not consummated, the board may decide to pursue dissolution and liquidation, likely resulting in a total loss for investors[135](index=135&type=chunk)[138](index=138&type=chunk) - The restructuring plan, which reduced the workforce by **83%**, may lead to unintended consequences such as loss of institutional knowledge and attrition beyond intended reductions, potentially harming operations[143](index=143&type=chunk) [Risks Related to Financial Position and Need for Capital](index=28&type=section&id=Risks%20Related%20to%20Financial%20Position%20and%20Need%20for%20Capital) Substantial doubt exists about the company's 'going concern' ability due to **$444.0 million** accumulated deficit and the need for significant additional funding - The company has determined there is substantial doubt about its ability to continue as a going concern within the next twelve months[146](index=146&type=chunk) - The company has incurred significant losses since inception, with a net loss of **$18.4 million** for Q1 2023 and an accumulated deficit of **$444.0 million** as of March 31, 2023[149](index=149&type=chunk) - Substantial additional funding is needed, and if the company is unable to raise capital, its business will be adversely affected[153](index=153&type=chunk) [Risks Related to Product Development and Regulatory Approval](index=30&type=section&id=Risks%20Related%20to%20Product%20Development%20and%20Regulatory%20Approval) Success depends on two product candidates, both facing setbacks; clinical programs are paused, with inconclusive pegtarviliase results and an FDA Refusal to File for pegzilarginase - The company has voluntarily paused its clinical programs since announcing its plan to explore strategic alternatives in April 2023[157](index=157&type=chunk) - The FDA issued a Refuse to File (RTF) letter for the pegzilarginase BLA, and interim results for the pegtarviliase Phase 1/2 trial were inconclusive due to the development of anti-drug antibodies in the third cohort[151](index=151&type=chunk)[152](index=152&type=chunk)[156](index=156&type=chunk) [Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO/CFO certifications and Inline XBRL documents

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-37722 AEGLEA BIOTHERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organizati ...

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37722 AEGLEA BIOTHERAPEUTICS, INC. | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | --- | ...