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 /PRNewswire/ -- 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.

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

 

 

(PRNewsfoto/Aeglea BioTherapeutics, Inc.)

 

 

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SOURCE Aeglea BioTherapeutics, Inc.

 
 
Company Codes: NASDAQ-NMS:AGLE
 

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