Agile Therapeutics Reports Third Quarter Financial Results
10 11월 2015 - 6:10AM
Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's health specialty
pharmaceutical company focused on the development and
commercialization of new prescription contraceptive products, today
reported financial results for the three and nine months ended
September 30, 2015 and provided a corporate update for the third
quarter 2015.
Third quarter 2015 and other recent
corporate developments include:
- In July 2015, the Company received notice that the U.S. Patent
and Trademark Office issued Notices of Allowance for four patent
applications with claims directed to novel transdermal
contraceptive dosing regimens. The allowances of these patent
applications provides the Company with an additional proprietary
platform for the development of new products based on the Company’s
lead product candidate Twirla® (AG200-15).
- In October 2015, the Company announced completion of subject
enrollment in its Phase 3 SECURE Clinical Trial for Twirla, its
investigational combined hormonal contraceptive patch. The
Company reported that the subject demographics enrolled are
consistent with the Company’s goal of a broadly representative
subject population including fewer than twenty percent of subjects
who are naïve to hormonal contraceptive products.
“We made significant progress in advancing our
SECURE clinical trial during the third quarter of 2015 through the
completion of subject enrollment,” said Al Altomari, Chief
Executive Officer and President of Agile. “As we continue to
execute on our core strategy, we will have a strong focus on the
continued execution of the SECURE trial while planning to manage
our financial resources in order to achieve our objectives.”
Third Quarter Financial
Results
- Cash and cash equivalents: As of
September 30, 2015, Agile had $39.4 million of cash and cash
equivalents compared to $40.2 million of cash and cash equivalents
as of December 31, 2014. Based on the current business plan, the
Company believes its cash and cash equivalents will be sufficient
to meet its operating requirements through the end of 2016.
In addition to its existing cash and cash equivalents, upon the
achievement of certain clinical milestones, the Company would be
eligible to draw an additional tranche of $8.5 million under the
terms of the loan and security agreement with Hercules Technology
Growth Capital, Inc.
- Research and development (R&D)
expenses: R&D expenses were $7.2 million for the
quarter ended September 30, 2015, compared to $4.6 million for the
comparable period in 2014. The increase in R&D expense of
$2.6 million was primarily due to clinical research organization
costs associated with the ongoing Phase 3 clinical trial for
Twirla.
- General and administrative (G&A)
expenses: G&A expenses were $1.8 million for the
quarter ended September 30, 2015, compared to $1.4 million for the
comparable period in 2014. The increase in G&A expenses
of $0.4 million was primarily due to increased stock-based
compensation expense associated with 2015 stock option
grants.
- Net loss: Net loss was $9.4 million, or
$0.42 per basic share for the quarter ended September 30, 2015,
compared to a net loss of $6.4 million, or $0.34 per basic share
for the quarter ended September 30, 2014.
- Shares Outstanding: At September 30,
2015, Agile had 22,292,167 shares of common stock outstanding.
About Agile Therapeutics,
Inc.Agile Therapeutics is a women's health specialty
pharmaceutical company focused on the development and
commercialization of new prescription contraceptive products. Our
product candidates are designed to provide women with contraceptive
options that offer greater convenience and facilitate compliance.
Our lead product candidate, Twirla®, (ethinyl estradiol and
levonorgestrel transdermal system), also known as AG200-15, is a
once-weekly prescription contraceptive patch currently in Phase 3
clinical development. Twirla is based on our proprietary
transdermal patch technology, called Skinfusion®, which is designed
to provide advantages over currently available patches and is
intended to optimize patch adherence and patient acceptability. For
more information, please visit the company website at
www.agiletherapeutics.com. The company may occasionally disseminate
material, nonpublic information on the company website.
Forward-Looking
StatementCertain information contained in this press
release includes "forward-looking statements" related to the
Company's, projected cash position, timeline for clinical trials
and potential market opportunity for its product candidates. We
may, in some cases use terms such as "predicts," "believes,"
"potential," "continue," "anticipates", "estimates," "expects,"
"plans," "intends," "may," "could," 'might," "will," "should" or
other words that convey uncertainty of the future events or
outcomes to identify these forward-looking statements. Our
forward-looking statements are based on current expectations that
involve risks, potential changes in circumstances, assumptions and
uncertainties. Any or all of the forward-looking statements may
turn out to be wrong, or be affected by inaccurate assumptions we
might make or by known or unknown risks and uncertainties. For
example, our statements about our projected cash position could be
affected by market factors, the inherent risks in our business, our
ability to execute the Company’s operational and budget plans, and
unforeseen events in our clinical and manufacturing development
plans; our statements about the timing and conduct of our clinical
trial could be affected by the potential that we identify serious
side effects or other safety issues, we do not have clinical supply
of our product candidate that is adequate in amount and quality and
supplied in a timely fashion, and the inherent risks of clinical
development; our statements about the potential commercial
opportunity could be affected by the potential that our product
does not receive regulatory approval, does not receive
reimbursement by third party payors, or a commercial market for the
product does not develop because of any of the risks inherent in
the commercialization of contraceptive products. For all these
reasons, actual results and developments could be materially
different from those expressed in or implied by our forward-looking
statements. All forward looking statements are subject to risks
detailed in our filings with the U.S. Securities and Exchange
Commission, including the Company's Annual Report on Form 10-K and
our Quarterly Reports on Form 10-Q. You are cautioned not to place
undue reliance on these forward-looking statements, which are made
only as of the date of this press release. We undertake no
obligation to publicly update such forward-looking statements to
reflect subsequent events or
circumstances.
Agile Therapeutics, Inc. |
Condensed Balance Sheets |
|
(in thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
September 30,
2015 |
|
|
|
December 31,
2014 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
39,404 |
|
|
$ |
40,182 |
|
Prepaid expenses |
|
1,261 |
|
|
|
804 |
|
Total current assets |
|
40,665 |
|
|
|
40,986 |
|
Property and equipment,
net . |
|
12,320 |
|
|
|
12,046 |
|
Other assets,
long-term |
|
2,100 |
|
|
|
1,794 |
|
Total assets |
$ |
55,085 |
|
|
$ |
54,826 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
Accounts payable and accrued
expenses |
$ |
6,698 |
|
|
$ |
3,693 |
|
Loan payable, current portion |
|
-- |
|
|
|
5,003 |
|
Warrant liability |
|
251 |
|
|
|
296 |
|
Total current
liabilities |
|
6,949 |
|
|
|
8,992 |
|
Loan payable,
long‑term |
|
15,390 |
|
|
|
9,828 |
|
|
|
|
Stockholders’
equity |
|
|
Common stock |
|
2 |
|
|
|
2 |
|
Additional paid‑in capital |
|
193,572 |
|
|
|
170,396 |
|
Accumulated deficit |
|
(160,828 |
) |
|
|
(134,392 |
) |
Total stockholders’
equity |
|
32,746 |
|
|
|
36,006 |
|
Total liabilities and
stockholders’ equity |
$ |
55,085 |
|
|
$ |
54,826 |
|
Agile
Therapeutics, Inc. |
Condensed
Statements of Operations |
|
(in thousands,
except share and per share amounts) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September
30, |
|
|
|
|
Nine Months Ended September
30, |
|
|
2015 |
|
|
|
2014 |
|
|
|
2015 |
|
|
2014 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
7,162 |
|
|
$ |
4,603 |
|
|
$ |
|
18,709 |
|
|
$ |
|
8,388 |
|
General and administrative |
|
1,803 |
|
|
|
1,446 |
|
|
|
5,215 |
|
|
3,603 |
|
Total operating
expenses |
|
8,966 |
|
|
|
6,049 |
|
|
|
23,924 |
|
|
11,991 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(8,966 |
) |
|
|
(6,049 |
) |
|
|
(23,924 |
) |
|
(11,991 |
) |
|
|
|
|
|
|
|
Interest expense, net |
|
(550 |
) |
|
|
(391 |
) |
|
|
(1,521 |
) |
|
(1,172 |
) |
Change in fair value of
warrants |
|
104 |
|
|
|
86 |
|
|
|
45 |
|
|
279 |
|
Loss on extinguishment of debt |
|
-- |
|
|
|
-- |
|
|
|
(1,036 |
) |
|
|
|
-- |
|
Loss before benefit from
income taxes |
|
(9,411 |
) |
|
|
(6,353 |
) |
|
|
(26,436 |
) |
|
(12,885 |
) |
Benefit from income
taxes |
|
-- |
|
|
|
-- |
|
|
|
|
|
-- |
|
|
3,652 |
|
Net
loss |
$ |
(9,411 |
) |
|
$ |
(6,353 |
) |
|
$ |
|
(26,436 |
) |
|
$ |
|
(9,232 |
) |
Net loss per
common share:Basic and Diluted |
$ |
(0.42 |
) |
|
$ |
(0.34 |
) |
|
$ |
|
(1.21 |
) |
|
$ |
|
(1.03 |
) |
Weighted-average
shares outstanding:Basic and Diluted |
|
22,272,777 |
|
|
|
18,592,968 |
|
|
|
21,923,070 |
|
|
8,967,324 |
|
Mary Coleman -- 609-356-1921
Agile Therapeutics (NASDAQ:AGRX)
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