agle-8k_20191106.htm

 

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): November 6, 2019

 

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.)

 

901 S. MoPac Expressway

Barton Oaks Plaza One

Suite 250

Austin, TX

78746

(Address of principal executive offices)

(Zip Code)

 

(512) 942-2935

(Registrant’s telephone number, including area code)

(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 Stock Market LLC

(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 November 6, 2019, Aeglea BioTherapeutics, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2019. 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 September 30, 2019, dated November 6, 2019.

 


2


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

 

AEGLEA BIOTHERAPEUTICS, INC.

 

 

 

 

 

 

 

Date: November 6, 2019

 

 

 

By:

 

/s/ Charles N. York II

 

 

 

 

 

 

Charles N. York II

 

 

 

 

 

 

Chief Financial Officer

 

 

3

agle-ex991_6.htm

Exhibit 99.1

 

Aeglea BioTherapeutics Reports Third Quarter 2019 Financial Results and Corporate Highlights

 

 

Austin, Texas, November 6, 2019 - Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that engineers next-generation human enzymes to provide solutions for diseases with unmet medical need, today reported financial results for the third quarter ended September 30, 2019 and corporate highlights.

“We are excited about our pivotal Phase 3 PEACE trial in Arginase 1 Deficiency (ARG1-D), given the positive 20-dose data from our completed Phase 1/2 trial and ongoing Phase 2 open-label extension trial for pegzilarginase in patients with ARG1-D,” said Anthony G. Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. “Additionally, we are delighted to welcome Dr. Ravi Rao as chief medical officer and Mike Hanley as chief commercial officer, key executive leadership team additions who will help shape our future and continue the momentum of our ARG1-D, homocystinuria and cystinuria programs.”

Recent Highlights

 

Aeglea presented positive 20-dose data on 14 patients from the Company’s completed Phase 1/2 trial and ongoing Phase 2 open-label extension (OLE) trial for pegzilarginase in patients with ARG1-D at the 2019 Symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM). All patients achieved a substantial reduction in plasma arginine with the median reduction of 274 µm from baseline to 20 doses. Aeglea reported 79% (11 of 14) of patients were clinical responders, using mobility assessment components that correspond with the PEACE trial’s secondary endpoint. Pegzilarginase was well tolerated and the rates of treatment-related adverse events decreased over time.

 

Data from 10 patients dosed subcutaneously (sc) with pegzilarginase in the ongoing OLE trial for ARG1-D demonstrated that sc administration of pegzilarginase controls plasma arginine levels. All 10 patients remain on pegzilarginase sc with no patient discontinuations.

 

Mike Hanley joined Aeglea as Chief Commercial Officer in October 2019. Mr. Hanley was previously Vice President and U.S. Chief Commercial Officer for Esteve Pharmaceuticals. He also served as Group Vice President and General Manager, Orphan Business Unit for Horizon Therapeutics. Mr. Hanley has 20 years of commercial leadership experience in the life sciences industry.

 

Dr. Ravi Rao joined the Company as Chief Medical Officer in November 2019. Dr. Rao comes to Aeglea from GlaxoSmithKline, where he served as Vice President, Global Medical Affairs Head, Immunology and Specialty Franchise, leading programs across a number of emerging disease areas. Dr. Rao completed his residency training in London and is a Member of the Royal College of Physicians, London. He received his MB. BChir from Cambridge University and his Ph.D. in vascular biology from Imperial College, London in the United Kingdom and completed a postdoctoral fellowship at Harvard Medical School.


Upcoming Events

Aeglea will be attending the following investor conferences, with details regarding the date and time of the presentations and webcasts to be announced prior to the events.

 

Jefferies 2019 London Healthcare Conference, November 20-21, London, UK

 

Evercore ISI HealthCONx, December 3, Boston, MA

 

Piper Jaffray Healthcare Conference, December 4-5, New York, NY

Aeglea will present a poster presentation titled “Impact of Enzymatic Degradation of Plasma Cystine in a Mouse Model of Cystinuria Under Dehydration Challenge” on Thursday, November 7th from 10:00 a.m. - 12:00 p.m. ET at the American Society of Nephrology Kidney Week annual meeting being held November 5 – 10 at the Walter E. Washington Convention Center in Washington, DC.

The Company expects to discuss the trial design for the AEB4104 program for homocystinuria during the investor conferences in the fourth quarter of 2019, prior to its filing of an IND or CTA in the first quarter of 2020.

Third Quarter 2019 Financial Results

As of September 30, 2019, Aeglea had available cash, cash equivalents, marketable securities and restricted cash of $90.2 million. Based on Aeglea’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations through the first quarter of 2021.


Research and development expenses totaled $17.8 million for the third quarter of 2019, compared with $8.9 million for the third quarter of 2018. The increase was primarily due to investing in manufacturing and pre-commercial activities for Aeglea’s lead product candidate, pegzilarginase, a ramp-up in toxicology, IND-enabling studies, and manufacturing activities for the Company’s AEB4104 program for homocystinuria, and expanded clinical development activity and personnel-related expenses.

General and administrative expenses totaled $4.3 million for the third quarter of 2019, compared with $3.3 million for the third quarter of 2018. This increase was primarily due to additional employee headcount, compensation, and facilities to support company growth.

Net loss totaled $21.6 million and $11.9 million for the third quarter of 2019 and 2018, respectively, with non-cash stock compensation expense of $1.4 million and $1.1 million for the third quarter of 2019 and 2018, respectively.

About Pegzilarginase in Arginase 1 Deficiency

Pegzilarginase is an enhanced human arginase that enzymatically depletes the amino acid arginine. Aeglea is developing pegzilarginase for the treatment of patients with Arginase 1 Deficiency, a rare debilitating disease presenting in childhood with persistent hyperargininemia, severe progressive neurological abnormalities and early mortality. Pegzilarginase is intended for use as an enzyme replacement therapy in patients to reduce elevated blood arginine levels. Aeglea’s Phase 1/2 and Phase 2 OLE data for pegzilarginase in patients with Arginase 1 Deficiency 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 Aeglea BioTherapeutics
Aeglea is a clinical-stage biotechnology company that engineers next-generation human enzymes with enhanced properties and novel activity to provide solutions for diseases with unmet medical need. Aeglea is developing pegzilarginase, its lead product candidate, for the treatment of Arginase 1 Deficiency which has received both Rare Pediatric Disease and Breakthrough Therapy Designation. Aeglea has two programs in IND-enabling studies for Homocystinuria and Cystinuria and an active discovery pipeline. 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 potential for expeditated development and review of pegzilarginase as of a result of the Breakthrough Therapy designation, the timing of announcements and updates relating to our clinical trials and related data, our ability to enroll patients into our clinical trials, success in our collaborations 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, 2019 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.



Media Contact:
David Calusdian

Sharon Merrill Associates

617.542.5300

AGLE@investorrelations.com

 

Investor Contact:
Joey Perrone

Director, Finance & Investor Relations

Aeglea BioTherapeutics
investors@aegleabio.com



Financials

Aeglea BioTherapeutics, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands, except share and per share amounts)

 

 

 

September 30,

 

 

December 31,

 

 

 

2019

 

 

2018

 

ASSETS

 

 

 

 

 

 

 

 

CURRENT ASSETS

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

24,545

 

 

$

22,461

 

Marketable securities

 

 

64,155

 

 

 

52,052

 

Prepaid expenses and other current assets

 

 

3,930

 

 

 

2,158

 

Total current assets

 

 

92,630

 

 

 

76,671

 

Restricted cash

 

 

1,500

 

 

 

 

Property and equipment, net

 

 

980

 

 

 

1,018

 

Operating lease right-of-use assets

 

 

4,872

 

 

 

 

Other non-current assets

 

 

114

 

 

 

50

 

TOTAL ASSETS

 

$

100,096

 

 

$

77,739

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,431

 

 

$

663

 

Operating lease liabilities

 

 

289

 

 

 

 

Accrued and other current liabilities

 

 

12,676

 

 

 

9,576

 

Total current liabilities

 

 

15,396

 

 

 

10,239

 

Non-current operating lease liabilities

 

 

4,867

 

 

 

 

Other non-current liabilities

 

 

38

 

 

 

72

 

TOTAL LIABILITIES

 

 

20,301

 

 

 

10,311

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized

as of September 30, 2019 and December 31, 2018; no shares issued

and outstanding as of September 30, 2019 and December 31, 2018

 

 

 

 

 

 

Common stock, $0.0001 par value; 500,000,000 shares authorized

as of September 30, 2019 and December 31, 2018; 28,923,241 shares

and 24,140,097 shares issued and outstanding as of September 30, 2019

and December 31, 2018, respectively

 

 

3

 

 

 

2

 

Additional paid-in capital

 

 

253,334

 

 

 

184,314

 

Accumulated other comprehensive income (loss)

 

 

78

 

 

 

(27

)

Accumulated deficit

 

 

(173,620

)

 

 

(116,861

)

TOTAL STOCKHOLDERS’ EQUITY

 

 

79,795

 

 

 

67,428

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

100,096

 

 

$

77,739

 

 

 


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,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant

 

$

 

 

$

 

 

$

 

 

$

3,888

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

17,839

 

 

 

8,929

 

 

 

47,034

 

 

 

24,921

 

General and administrative

 

 

4,307

 

 

 

3,314

 

 

 

11,391

 

 

 

9,125

 

Total operating expenses

 

 

22,146

 

 

 

12,243

 

 

 

58,425

 

 

 

34,046

 

Loss from operations

 

 

(22,146

)

 

 

(12,243

)

 

 

(58,425

)

 

 

(30,158

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

585

 

 

 

339

 

 

 

1,711

 

 

 

745

 

Other expense, net

 

 

(12

)

 

 

(13

)

 

 

(45

)

 

 

(37

)

Total other income

 

 

573

 

 

 

326

 

 

 

1,666

 

 

 

708

 

Net loss

 

$

(21,573

)

 

$

(11,917

)

 

$

(56,759

)

 

$

(29,450

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.66

)

 

$

(0.54

)

 

$

(1.80

)

 

$

(1.49

)

Weighted-average common shares outstanding, basic and

   diluted

 

 

32,894,205

 

 

 

21,986,989

 

 

 

31,596,321

 

 

 

19,772,077