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Aeglea BioTherapeutics Provides Corporate Update and Reports Second Quarter 2017 Financial Results

AUSTIN, Texas, Aug. 09, 2017 (GLOBE NEWSWIRE) -- Aeglea BioTherapeutics, Inc., (NASDAQ:AGLE) a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat rare genetic diseases and cancer, today provided a corporate update and reported financial results for the second quarter ended June 30, 2017.

“With our newly expanded and strengthened management team, we are well positioned to advance our clinical development strategy for AEB1102 for both our rare genetic diseases and cancer programs,” said Anthony Quinn, M.B Ch.B, Ph.D., interim chief executive officer of Aeglea. “Additionally, given the progress we have made in our dose escalation trials, we look forward to initiating our solid tumor expansion arms either in the fourth quarter of 2017 or the first quarter of 2018.”      

Corporate Update

• Selected three single agent solid tumor expansion arms for Phase 1 clinical trial of AEB1102 in cutaneous melanoma, uveal melanoma and small cell lung cancer, all of which have demonstrated a dependence on arginine in published literature and preclinical studies. Each expansion arm will enroll up to 12 patients and are planned to initiate in the fourth quarter of 2017 or first quarter of 2018, following completion of the dose escalation phase.

• Named Anthony Quinn, M.B Ch.B, Ph.D., as interim chief executive officer while the company conducts a comprehensive search for a permanent CEO. Dr. Quinn is a member of Aeglea’s board of directors. He previously led R&D at Synageva and served as Aeglea’s interim chief medical officer earlier this year.

• Strengthened management team with two key hires:

  • James Wooldridge, MD was named chief medical officer and brings a wealth of clinical development experience to the team. Dr. Wooldridge previously served as chief scientific officer for immuno-oncology clinical development at Eli Lilly & Company.

  • Aaron Schuchart was named chief business officer and will oversee business development activities and facilitate corporate strategy. Mr. Schuchart joined Aeglea from Coherus Biosciences, where he served as senior vice president of business development and strategic alliances.

Upcoming Events

• Dr. Quinn and Charles York, chief financial officer of Aeglea, will present a corporate update at the Wells Fargo Healthcare Conference being held September 6 – 7 in Boston, MA.

Second Quarter 2017 Financial Results

On June 30, 2017, Aeglea had available cash, cash equivalents and marketable securities of $63.4 million, which includes approximately $11.4 million in net proceeds from a follow-on public offering closed in June 2017. Based on Aeglea’s current operating plan, management believes that it has sufficient capital resources to fund anticipated operations through the third quarter of 2019.

Aeglea recognized grant revenues of $1.5 million in the second quarter of 2017, compared with $1.4 million in the second quarter of 2016. The grant revenues are the result of a $19.8 million research grant received from the Cancer Prevention and Research Institute of Texas (CPRIT). The increase was primarily due to additional qualifying expenditures associated with the clinical trials for AEB1102 in patients with advanced solid tumors and the hematological malignancies acute myeloid leukemia and myelodysplastic syndrome.

Research and development expenses totaled $5.8 million for the second quarter of 2017, compared with $4.4 million for the second quarter of 2016. The increase was primarily associated with hiring additional personnel to expand Aeglea’s internal regulatory, laboratory, and clinical development capabilities, as well as manufacturing activities for AEB1102 and other pipeline programs. 

General and administrative expenses totaled $2.4 million for the second quarter of 2017 and were consistent with $2.4 million for the second quarter of 2016.

Net loss totaled $6.6 million and $5.4 million for the second quarter of 2017 and 2016, respectively.

About Aeglea BioTherapeutics

Aeglea is a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat rare genetic diseases and cancer. The company’s engineered human enzymes are designed to modulate the extremes of amino acid metabolism in the blood to reduce toxic levels of amino acids in inborn errors of metabolism or target tumor metabolism for cancer treatment. AEB1102, Aeglea’s lead product candidate, is currently being studied in two ongoing Phase 1 clinical trials in patients with advanced solid tumors and acute myeloid leukemia/myelodysplastic syndrome (AML/MDS). Additionally, Aeglea is recruiting patients into its ongoing Phase 1/2 trial of AEB1102 for the treatment of patients with Arginase 1 Deficiency. The company is building a pipeline of additional product candidates targeting key amino acids, including AEB4104, which degrades homocystine, a target for an inborn error of metabolism, as well as two potential treatments for cancer, AEB3103, which degrades cysteine, and its oxidized form cystine, and AEB2109, which degrades methionine. 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, 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 June 30, 2017 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.


Aeglea BioTherapeutics, Inc.
Condensed Consolidated Balance Sheets
 
 (In thousands, except share and per share amounts)
             
     June 30,     December 31,  
    2017     2016  
ASSETS                
CURRENT ASSETS                
Cash and cash equivalents   $ 26,934     $ 47,748  
Marketable securities     36,459       15,754  
Accounts receivable - grant     1,213       1,215  
Prepaid expenses and other current assets     1,597       1,707  
Total current assets     66,203       66,424  
Property and equipment, net     802       599  
Other non-current assets     139       40  
TOTAL ASSETS   $ 67,144     $ 67,063  
                 
LIABILITIES AND STOCKHOLDERS EQUITY                
CURRENT LIABILITIES                
Accounts payable   $ 634     $ 168  
Deferred revenue     71       71  
Accrued and other current liabilities     3,713       3,726  
Total current liabilities     4,418       3,965  
Other non-current liabilities     122       132  
TOTAL LIABILITIES     4,540       4,097  
                 
STOCKHOLDERS’ EQUITY                
Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of
  June 30, 2017 and December 31, 2016; no shares issued and
  outstanding as of June 30, 2017 and December 31, 2016
           
Common stock, $0.0001 par value; 500,000,000 shares authorized as of
  June 30, 2017 and December 31, 2016; 16,452,260 shares and
  13,430,833 shares issued and outstanding as of June 30, 2017 and
  December 31, 2016, respectively
    2       1  
Additional paid-in capital     120,787       108,246  
Accumulated other comprehensive loss     (29 )     (4 )
Accumulated deficit     (58,156 )     (45,277 )
TOTAL STOCKHOLDERS’ EQUITY     62,604       62,966  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY   $ 67,144     $ 67,063  


Aeglea BioTherapeutics, Inc.
Condensed Consolidated Statements of Operations
 
(In thousands, except share and per share amounts)
 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2017     2016     2017     2016  
Revenues:                                
Grant   $ 1,479     $ 1,373     $ 2,462     $ 2,232  
                                 
Operating expenses:                                
Research and development     5,835       4,420       10,784       8,017  
General and administrative     2,364       2,448       4,729       4,277  
Total operating expenses     8,199       6,868       15,513       12,294  
Loss from operations     (6,720 )     (5,495 )     (13,051 )     (10,062 )
                                 
Other income (expense):                                
Interest income     100       74       195       100  
Other expense, net     (12 )     (9 )     (23 )     (15 )
Total other income     88       65       172       85  
Net loss   $ (6,632 )   $ (5,430 )   $ (12,879 )   $ (9,977 )
                                 
Net loss per share, basic and diluted   $ (0.47 )   $ (0.46 )   $ (0.94 )   $ (1.61 )
Weighted-average common shares outstanding, basic and diluted     14,114,101       11,776,058       13,742,029       6,208,379  


Media Contact:
Kelly Boothe, Ph.D.
Pure Communications
415.946.1076
media@aegleabio.com

Investor Contact:
Charles N. York II
Chief Financial Officer
Aeglea BioTherapeutics
investors@aegleabio.com

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