Aeglea BioTherapeutics Reports Third Quarter 2020 Financial Results and Corporate Highlights

 

AUSTIN, Texas, Nov. 5, 2020 /PRNewswire/ -- Aeglea Biotherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare and other high-burden diseases, today reported its third quarter 2020 financial results, and provided recent corporate and program highlights.

"Although it's been a challenging environment for biotech with the global pandemic, we have continued to be productive in our Arginase 1 Deficiency patient identification and engagement efforts. I am pleased with the progress we are making overall as well as specifically at our PEACE trial sites," said Anthony Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. "I am also excited by the momentum we are building in our Homocystinuria program with the recent granting of U.S. Orphan Drug Designation and a positive opinion for EU Orphan Drug Designation for ACN00177."

Recent Highlights and Updates

Pegzilarginase in Arginase 1 Deficiency

  • In September, Aeglea announced the PEACE Phase 3 pivotal trial was more than 50% enrolled with nearly twice the number of patients needed to complete enrollment identified at active trial sites. Enrollment for the trial is anticipated to be completed in January 2021.
  • As of September, Aeglea has identified over 250 Arginase 1 Deficiency patients in addressable markets, a 25% increase relative to the prior year. The number of currently identified patients represents more than 50% and 30% of the estimated genetic prevalence populations in the U.S. and EU5, respectively.

ACN00177 in Homocystinuria

  • In October, Aeglea announced the U.S. Food and Drug Administration granted Orphan Drug Designation to ACN00177 for the treatment of Homocystinuria.
  • Additionally, the European Medicines Agency Committee for Orphan Medicinal Products issued a positive opinion recommending Orphan Drug Designation for ACN00177 for the treatment of Homocystinuria in the European Union.

Corporate

  • In October, the Company strengthened its financial position with proceeds from shares of common stock sold under its ATM program, resulting in gross proceeds of $25 million, extending its cash runway into 2023.

Upcoming Events

Aeglea will be attending the following virtual investor conferences in the fourth quarter:

  • Piper Sandler 32nd Annual Virtual Healthcare Conference, December 1-3
  • 3rd Annual Evercore ISI HealthCONx Conference, December 1-3

Third Quarter 2020 Financial Results

As of September 30, 2020, Aeglea had available cash, cash equivalents, marketable securities and restricted cash of $141.5 million. In addition, in October 2020 the Company raised approximately $24.6 million in net proceeds from shares of common stock sold under its ATM program. Based on Aeglea's current operating plan, and taking into account the net offering proceeds, management believes it has sufficient capital resources to fund anticipated operations into 2023.

Research and development expenses totaled $12.5 million for the third quarter of 2020 and $17.8 million for the third quarter of 2019. The decrease was primarily associated with completing certain manufacturing and pre-commercial activities for Aeglea's lead product candidate, pegzilarginase, completing a Phase 1/2 clinical trial in patients with Arginase 1 Deficiency and closing cancer trials; offset by a ramp-up in manufacturing for ACN00177 in Homocystinuria and higher personnel-related expenses. 

General and administrative expenses totaled $5.7 million for the third quarter of 2020 and $4.3 million for the third quarter of 2019. This increase was primarily due to ramping-up commercial capabilities and additional facilities to support company growth.

Net loss totaled $18.0 million and $21.6 million for the third quarter of 2020 and 2019, respectively, with non-cash stock compensation expense of $1.7 million and $1.4 million for the third quarter of 2020 and 2019, respectively.

About Pegzilarginase in Arginase 1 Deficiency

Pegzilarginase is an enhanced human arginase that enzymatically lowers levels of the amino acid arginine. Aeglea is developing pegzilarginase for the treatment of patients with Arginase 1 Deficiency (ARG1-D), a rare debilitating, progressive disease presenting in childhood with persistent hyperargininemia, spasticity, developmental delay, intellectual disability, seizures and early mortality. Pegzilarginase is intended for use as an enzyme therapy to reduce elevated blood arginine levels in patients with ARG1-D. Aeglea's Phase 1/2 and Phase 2 open-label extension data for pegzilarginase in patients with ARG1-D demonstrated clinical improvements and sustained lowering of plasma arginine. The Company's single, global pivotal Phase 3 PEACE trial is designed to assess the effects of treatment with pegzilarginase versus placebo over 24 weeks with a primary endpoint of plasma arginine reduction.

About ACN00177 in Homocystinuria

Aeglea is developing ACN00177 for the treatment of patients with cystathionine beta synthase (CBS) deficiency, also known as Classical Homocystinuria. Homocysteine accumulation plays a key role in multiple progressive and serious disease-related complications, including thromboembolic vascular events, skeletal abnormalities including severe osteoporosis, developmental delay, intellectual disability, lens dislocation and severe near-sightedness. ACN00177 has been designed as a novel recombinant human enzyme, which degrades the amino acid homocysteine and its related homocystine dimer. With this mechanism, ACN00177 is intended to lower the abnormally high blood levels of homocysteine in patients with Homocystinuria. Preclinical data demonstrated that ACN00177 improved important disease-related abnormalities and survival in a mouse model of Homocystinuria. The Company initiated a Phase 1/2 trial in the second quarter of 2020 and continues patient identification and administrative activities. The timing of first patient dosing in this Phase 1/2 trial will depend on determinations by individual sites as they adjust to impacts from COVID-19. ACN00177 has been granted Orphan Drug Designation by the U.S. FDA and received a positive opinion on Orphan Drug Designation from the European Medicines Agency.

About Aeglea BioTherapeutics

Aeglea BioTherapeutics is a clinical-stage biotechnology company redefining the potential of human enzyme therapeutics to benefit people with rare and other high burden diseases. Aeglea's lead product candidate, pegzilarginase, is in a pivotal Phase 3 trial for the treatment of Arginase 1 Deficiency and has received both Rare Pediatric Disease and Breakthrough Therapy Designations. The Company initiated a Phase 1/2 clinical trial of ACN00177 for the treatment of Homocystinuria in the second quarter of 2020. Aeglea has an active discovery platform, with the most advanced program for Cystinuria. For more information, please visit http://aegleabio.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: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "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 we expect. Examples of forward-looking statements include, among others, statements we make regarding our cash forecasts, the timing and success of our clinical trials and related data, the timing and expectations for regulatory submissions and approvals, timing and results of meetings with regulators, the timing of announcements and updates relating to our clinical trials and related data, our ability to enroll patients into our clinical trials, the expected impact of the COVID-19 pandemic on our operations and clinical trials, success in our collaborations, the potential addressable markets of the our product candidates and the potential therapeutic benefits and economic value of our lead product candidate or other product candidates. Further information on potential risk factors that could affect our business and its financial results are detailed in our most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

 

Financials

Aeglea BioTherapeutics, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

 

(In thousands, except share and per share amounts)

 
   

September 30,

   

December 31,

 
   

2020

   

2019

 

ASSETS

               

CURRENT ASSETS

               

Cash and cash equivalents

 

$

54,223

   

$

19,253

 

Marketable securities

   

85,753

     

52,696

 

Prepaid expenses and other current assets

   

4,423

     

2,556

 

Total current assets

   

144,399

     

74,505

 

Restricted cash

   

1,500

     

1,500

 

Property and equipment, net

   

5,216

     

2,385

 

Operating lease right-of-use assets

   

4,394

     

4,726

 

Other non-current assets

   

122

     

67

 

TOTAL ASSETS

 

$

155,631

   

$

83,183

 
                 

LIABILITIES AND STOCKHOLDERS' EQUITY

               

CURRENT LIABILITIES

               

Accounts payable

 

$

2,295

   

$

3,154

 

Operating lease liabilities

   

341

     

351

 

Accrued and other current liabilities

   

11,713

     

14,854

 

Total current liabilities

   

14,349

     

18,359

 

Non-current operating lease liabilities

   

4,947

     

4,712

 

Other non-current liabilities

   

61

     

31

 

TOTAL LIABILITIES

   

19,357

     

23,102

 
                 

STOCKHOLDERS' EQUITY

               

Preferred stock, $0.0001 par value; 10,000,000 shares authorized
as of September 30, 2020 and December 31, 2019; no shares issued and
outstanding as of September 30, 2020 and December 31, 2019

   

     

 

Common stock, $0.0001 par value; 500,000,000 shares authorized
 as of September 30, 2020 and December 31, 2019; 44,692,030 shares and
 29,084,437 shares issued and outstanding as of September 30, 2020
 and December 31, 2019, respectively

   

5

     

3

 

Additional paid-in capital

   

389,543

     

255,142

 

Accumulated other comprehensive income

   

20

     

51

 

Accumulated deficit

   

(253,294)

     

(195,115)

 

TOTAL STOCKHOLDERS' EQUITY

   

136,274

     

60,081

 

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

 

$

155,631

   

$

83,183

 

 

 

Aeglea BioTherapeutics, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

 

 (In thousands, except share and per share amounts)

 
   

Three Months Ended

September 30,

   

Nine Months Ended

September 30,

 
   

2020

   

2019

   

2020

   

2019

 

Operating expenses:

                               

Research and development

   

12,451

     

17,839

     

43,882

     

47,034

 

General and administrative

   

5,672

     

4,307

     

14,823

     

11,391

 

Total operating expenses

   

18,123

     

22,146

     

58,705

     

58,425

 

Loss from operations

   

(18,123)

     

(22,146)

     

(58,705)

     

(58,425)

 
                                 

Other income (expense):

                               

Interest income

   

88

     

585

     

549

     

1,711

 

Other income (expense), net

   

2

     

(12)

     

(23)

     

(45)

 

Total other income

   

90

     

573

     

526

     

1,666

 

Net loss

 

$

(18,033)

   

$

(21,573)

   

$

(58,179)

   

$

(56,759)

 
                                 

Net loss per share, basic and diluted

 

$

(0.29)

   

$

(0.66)

   

$

(1.18)

   

$

(1.80)

 

Weighted-average common shares outstanding, basic and

   diluted

   

62,240,412

     

32,894,205

     

49,473,350

     

31,596,321

 

 

 

(PRNewsfoto/Aeglea BioTherapeutics, Inc.)

 

 

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SOURCE Aeglea BioTherapeutics, Inc.

 
 
Company Codes: NASDAQ-NMS:AGLE
 

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