8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, 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 of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
805 Las Cimas Parkway 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 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 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)

	March 31,			December 31,
	2023			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

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,    basic and diluted		94,262,660			65,996,161

XML

Document And Entity Information	May 11, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 11, 2023
Entity Registrant Name	AEGLEA BIOTHERAPEUTICS, INC.
Entity Central Index Key	0001636282
Entity Emerging Growth Company	false
Securities Act File Number	001-37722
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	46-4312787
Entity Address, Address Line One	805 Las Cimas Parkway
Entity Address, Address Line Three	Suite 100
Entity Address, City or Town	Austin
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	78746
City Area Code	(512)
Local Phone Number	942-2935
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.0001 Par Value Per Share
Trading Symbol	AGLE
Security Exchange Name	NASDAQ