8-K
Spyre Therapeutics, Inc. (SYRE)
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
| Date of Report (Date of earliest event reported): May 11, 2023 |
|---|
AEGLEA BIOTHERAPEUTICS, INC.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 001-37722 | 46-4312787 |
|---|---|---|
| (State or Other Jurisdiction<br>of Incorporation) | (Commission File Number) | (IRS Employer<br>Identification No.) |
| 805 Las Cimas Parkway<br><br>Suite 100 | ||
| Austin, Texas | 78746 | |
| (Address of Principal Executive Offices) | (Zip Code) | |
| Registrant’s Telephone Number, Including Area Code: (512) 942-2935 | ||
| --- |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br>Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, $0.0001 Par Value Per Share | AGLE | The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 11, 2023, Aeglea BioTherapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2023. A copy of the press release is attached as Exhibit 99.1 to this report.
The information in this Item 2.02, including Exhibit 99.1 to this report, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description |
|---|---|
| 99.1 | Press release issued by Aeglea BioTherapeutics, Inc. regarding its financial results for the quarter ended March 31, 2023 dated May 11, 2023. |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AEGLEA BIOTHERAPEUTICS, INC. | |||
|---|---|---|---|
| Date: | May 11, 2023 | By: | /s/ Jonathan Alspaugh |
| Jonathan Alspaugh<br>Chief Financial Officer |
EX-99
Exhibit 99.1
Aeglea BioTherapeutics Reports First Quarter 2023 Financial Results
$39.8 million of cash and cash equivalents, marketable securities, and restricted cash as of March 31, 2023
Austin, Texas, May 11, 2023 - Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE) today announced financial results for the first quarter 2023.
First Quarter 2023 Financial Results
As of March 31, 2023, Aeglea had available cash and cash equivalents, marketable securities and restricted cash of $39.8 million.
Aeglea recognized development fee and royalty revenues of $0.2 million in the first quarter of 2023, as a result of its license and supply agreement with Immedica Pharma AB for the commercial rights to pegzilarginase in Europe and several countries in the Middle East (License and Supply Agreement). The revenues recorded in the first quarter of 2023 are related to the PEACE Phase 3 trial and royalties from an early access program in France. Aeglea recognized $1.4 million for the first quarter of 2022 in development fee revenues.
Research and development expenses totaled $13.8 million for the first quarter of 2023 and $17.0 million for the first quarter of 2022. The decrease was primarily related to a decrease in activities related to the PEACE Phase 3 trial and Biologics License Application for pegzilarginase.
General and administrative expenses totaled $5.2 million for the first quarter of 2023 and $8.8 million for the first quarter of 2022. This decrease was primarily due to a reduction in headcount and related expenses and decrease in commercialization activities for pegzilarginase.
Net loss totaled $18.4 million and $24.4 million for the first quarter of 2023 and 2022, respectively, which includes non-cash stock compensation expense of $1.7 million and $2.1 million for the first quarter of 2023 and 2022, respectively.
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 has investigated pegtarviliase in a Phase 1/2 clinical trial for the treatment of Classical Homocystinuria. Aeglea’s other clinical program, pegzilarginase, 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. Aeglea 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. For more information, please visit http://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: "believe," “continue,” "goal," "expect," "may," “intend,” “potential,” "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 the Company expects. Examples of forward-looking statements include, among others, statements the Company makes regarding its ability to consummate any strategic alternatives and the timing thereof, including updates concerning the process to explore strategic alternatives, and other statements that are not historical fact. Actual results may differ materially from those indicated by such forward-looking statements. Factors that could cause actual results to differ include, but are not limited to, risks that the Company may not execute its planned exploration and evaluation of strategic alternatives; the availability of suitable third parties with which to conduct contemplated strategic transactions; the risk that the Company’s reduction in force efforts may not generate their intended benefits to the extent or as quickly as anticipated; and the risk that the Company’s reduction in force efforts may negatively impact the Company’s business operations and reputation. Additional risks and uncertainties regarding the Company’s business can be found in the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, as supplemented by the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, each filed with the United States Securities and Exchange Commission (“SEC”), and future filings and reports that the Company makes from time to time with the SEC. The information contained in this press release is as of the date of this release, and the Company undertakes no duty to update forward-looking statements contained in this press release except as required by applicable laws.
Contact Information:
Jonathan Alspaugh, Chief Financial Officer
investors@aeglea.com
Financials
Aeglea BioTherapeutics, Inc.
Consolidated Balance Sheets
(Unaudited, in thousands, except share and per share amounts)
| December 31, | |||||
|---|---|---|---|---|---|
| 2022 | |||||
| ASSETS | |||||
| CURRENT ASSETS | |||||
| Cash and cash equivalents | 35,243 | $ | 34,863 | ||
| Marketable securities | 3,235 | 20,848 | |||
| Development receivables | 330 | 375 | |||
| Prepaid expenses and other current assets | 5,567 | 6,172 | |||
| Total current assets | 44,375 | 62,258 | |||
| Restricted cash | 1,310 | 1,553 | |||
| Property and equipment, net | 3,424 | 3,220 | |||
| Operating lease right-of-use assets | 3,266 | 3,430 | |||
| Other non-current assets | 78 | 683 | |||
| TOTAL ASSETS | 52,453 | $ | 71,144 | ||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
| CURRENT LIABILITIES | |||||
| Accounts payable | 2,062 | $ | 677 | ||
| Operating lease liabilities | 608 | 625 | |||
| Deferred revenue | 302 | 517 | |||
| Accrued and other current liabilities | 9,665 | 12,837 | |||
| Total current liabilities | 12,637 | 14,656 | |||
| Non-current operating lease liabilities | 3,823 | 4,004 | |||
| Deferred revenue, net of current portion | 2,341 | 2,179 | |||
| TOTAL LIABILITIES | 18,801 | 20,839 | |||
| Commitments and Contingencies (Note 7) | |||||
| STOCKHOLDERS’ EQUITY | |||||
| Preferred stock, 0.0001 par value; 10,000,000 shares authorized as of March 31, 2023 and December 31, 2022; no shares issued and outstanding as of March 31, 2023 and December 31, 2022 | — | — | |||
| Common stock, 0.0001 par value; 500,000,000 shares authorized as of March 31, 2023 and December 31, 2022; 65,395,159 shares and 65,350,343 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 6 | 6 | |||
| Additional paid-in capital | 477,698 | 475,971 | |||
| Accumulated other comprehensive loss | (6 | ) | (48 | ) | |
| Accumulated deficit | (444,046 | ) | (425,624 | ) | |
| TOTAL STOCKHOLDERS’ EQUITY | 33,652 | 50,305 | |||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | 52,453 | $ | 71,144 |
All values are in US Dollars.
Aeglea BioTherapeutics, Inc.
Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share amounts)
| Three Months Ended | ||||||
|---|---|---|---|---|---|---|
| March 31, | ||||||
| 2023 | 2022 | |||||
| Revenue: | ||||||
| Development fee and royalty | $ | 198 | $ | 1,362 | ||
| Total revenue | 198 | 1,362 | ||||
| Operating expenses: | ||||||
| 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 | ) | ||
| Other income (expense): | ||||||
| Interest income | 420 | 35 | ||||
| Other income (expense), net | (72 | ) | (30 | ) | ||
| Total other income (expense) | 348 | 5 | ||||
| Loss before income tax expense | (18,458 | ) | (24,436 | ) | ||
| Income tax benefit (expense) | 36 | — | ||||
| Net loss | $ | (18,422 | ) | $ | (24,436 | ) |
| Net loss per share, basic and diluted | $ | (0.20 | ) | $ | (0.37 | ) |
| Weighted-average common shares outstanding, <br> basic and diluted | 94,262,660 | 65,996,161 |