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 StatementsThis
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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