Agile Therapeutics Reports First Quarter 2017 Financial Results
09 5월 2017 - 5:11AM
Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's healthcare
company today reported financial results for the three months ended
March 31, 2017, and provided a corporate update for the first
quarter 2017.
First quarter 2017 and other recent
corporate developments include:
- Twirla® Update – In January 2017, the
Company announced positive top-line results from its Phase 3 SECURE
clinical trial of Twirla®, its investigational low-dose combined
hormonal contraceptive patch. SECURE was a multicenter,
single-arm, open-label, 13 cycle trial that evaluated the safety,
efficacy and tolerability of Twirla in 2,032 healthy women, aged 18
and over, at 102 experienced investigative sites across the United
States. In April 2017, the Company announced it had received the
final meeting minutes from its recent New Drug Application (NDA)
pre-submission meeting with the U.S. Food and Drug Administration
(FDA) for Twirla. Based on the feedback from the FDA, the
Company believes it has the necessary information needed to
complete the resubmission of its NDA, which is expected to be
submitted by the end of the second quarter of 2017.
- Medical Congress Updates – In March 2017,
the Company announced a poster presentation of data from the Phase
3 SECURE clinical trial for Twirla. The poster, titled “The
SECURE Study, a Real-World Trial of a Low-Dose Contraceptive
Patch: Addressing the Changing U.S. Population,” was
presented at the Contraceptive Technology Conferences in San
Francisco, CA and Boston, MA. The first author is Anita
Nelson, MD, one of the co-primary investigators for the SECURE
trial. On April 29, 2017, Dr. Anita Nelson presented “An Update on
Hormonal Contraception and The Changing U.S. Population” at the
Academy of Women’s Health, and on May 6, 2017, the Company also
presented an interactive ePoster session during the 2017 Annual
Clinical and Scientific Meeting of the American Congress of
Obstetricians and Gynecologists. The ePoster included
efficacy and safety findings for the overall population and
pre-specified body mass index categories in the SECURE clinical
trial. The ePoster also included results on the bleeding
profile of subjects in the SECURE trial that have not previously
been reported.
- Hercules Loan and Security Agreement Amendment
– In May 2017, the Company amended its loan and security agreement
with Hercules Capital, Inc. (Hercules) to extend the period during
which the Company may draw an additional tranche of $8.5 million
until January 31, 2018 subject to the consent of Hercules.
“During the first quarter, we continued to
advance towards our goal of receiving regulatory approval for
Twirla, participated in a productive pre-submission meeting with
the FDA and continued to prepare our NDA for
resubmission. Additionally we have had multiple scientific
opportunities to discuss our Phase 3 SECURE trial results at
medical conferences. We continue to expect to submit our NDA
by the end of the second quarter of 2017,” said Al Altomari,
Chairman and Chief Executive Officer of Agile. “Additionally, we
continue to focus on developing our commercialization plans in
coordination with the prudent management of our capital
resources. We believe that the flexibility built into our
business plan can enable us to fund our operations into the second
quarter of 2018.”
First Quarter Financial
Results
- Cash and cash equivalents: As of March
31, 2017, Agile had $41.7 million of cash and cash equivalents
compared to $48.8 million of cash and cash equivalents as of
December 31, 2016. Based on the Company’s current
business plan, the Company believes its cash and cash equivalents
as of March 31, 2017, will be sufficient to meet its operating
requirements into the second quarter of 2018. The Company’s
current business plan assumes resubmission of the NDA for Twirla by
the end of the second quarter of 2017, a six month FDA review of
the Company’s resubmission, initiation of pre-commercial activities
and initiation of validation of its commercial manufacturing
process in coordination with the commercialization of Twirla. The
Company will require additional capital for the commercial launch
of Twirla, if approved, as well as advancing the development of its
other product candidates. In the event of unforeseen changes to its
planned timelines, the Company has the ability to postpone certain
commercial and validation spending that the Company believes will
allow it to continue the funding of its operations into the second
quarter of 2018.
- Research and development (R&D)
expenses: R&D expenses were $4.7 million for the
quarter ended March 31, 2017, compared to $4.9 million for the
comparable period in 2016. The decrease in R&D expense
was primarily due to decreased clinical development expenses as the
Company’s Phase 3 SECURE clinical trial for Twirla moved into the
close-out phase. The decreased clinical development expenses
were offset, in part, by expenses associated with commercial
manufacturing scale-up activities.
- General and administrative (G&A)
expenses: G&A expenses were $2.4 million for the
quarter ended March 31, 2017, compared to $2.1 million for the
comparable period in 2016. The increase in G&A expenses
was primarily due to increased pre-commercialization
activities.
- Net loss: Net loss was $7.5 million, or
$0.26 per basic share for the quarter ended March 31, 2017,
compared to a net loss of $7.3 million, or $0.27 per basic share
for the quarter ended March 31, 2016.
- Shares Outstanding: At March 31, 2017,
Agile had 28,776,398 shares of common stock outstanding.
About Agile Therapeutics,
Inc.Agile Therapeutics is a forward-thinking women's
healthcare company dedicated to fulfilling the unmet health needs
of today’s women. Our product candidates are designed to
provide women with contraceptive options that offer freedom from
taking a daily pill, without committing to a longer-acting method.
Our lead product candidate, Twirla®, (ethinyl estradiol and
levonorgestrel transdermal system), also known as AG200-15, is a
once-weekly prescription contraceptive patch that recently
completed Phase 3 trials. 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 adhesion and patient wearability. 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 clinical trials, regulatory submissions, projected cash
position 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 beliefs and
expectations of our management team 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. Our statements about the results
and conduct of our clinical trial could be affected by the
potential that there are changes in the data or interpretation of
the data by the FDA (for example, the FDA may include additional
pregnancies in its calculation of the Pearl Index, which would
increase the Pearl Index), whether the results will be deemed
satisfactory by the FDA (for example, we describe the results of
the SECURE trial as positive, the FDA may disagree with that
characterization), and whether additional studies will be required
or other issues will arise that will delay resubmission of our NDA
or negatively impact acceptance, review and approval of Twirla by
the FDA; 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, the
FDA does not approve Twirla, the FDA’s timeline for review is not
completed within six months, our ability to timely complete the
qualification and validation of our commercial manufacturing
process, and unforeseen events in our clinical and manufacturing
development plans; 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) |
|
|
March 31, 2017 |
|
December 31, 2016 |
Assets |
|
|
|
|
|
Current assets: |
|
|
Cash and
cash equivalents |
$41,744 |
|
|
$48,750 |
|
Prepaid
expenses |
|
2,525 |
|
|
|
2,768 |
|
Total current
assets |
|
44,269 |
|
|
|
51,518 |
|
Property and equipment,
net |
|
12,330 |
|
|
|
12,330 |
|
Other assets |
|
18 |
|
|
|
18 |
|
Total assets |
$56,617 |
|
|
$63,866 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
Current
liabilities: |
|
|
Accounts
payable and accrued expenses |
$5,749 |
|
|
$5,402 |
|
Loan
payable, current portion |
|
5,780 |
|
|
|
5,104 |
|
Warrant
liability |
|
63 |
|
|
|
172 |
|
Total current
liabilities |
|
11,592 |
|
|
|
10,678 |
|
Loan payable,
long‑term |
|
9,416 |
|
|
|
10,899 |
|
|
|
|
Stockholders’
equity |
|
|
Common stock |
|
3 |
|
|
|
3 |
|
Additional paid‑in capital |
|
236,590 |
|
|
|
235,754 |
|
Accumulated deficit |
|
(200,984 |
) |
|
|
(193,468 |
) |
Total stockholders’
equity |
|
35,609 |
|
|
|
42,289 |
|
Total liabilities and
stockholders’ equity |
$56,617 |
|
|
$63,866 |
|
Agile Therapeutics, Inc. |
Condensed Statements of
Operations |
|
|
(in thousands, except share and per share
amounts) |
(Unaudited) |
|
|
|
Three Months Ended March 31, |
|
|
2017 |
|
|
|
2016 |
|
Operating
expenses: |
|
|
|
|
|
Research
and development |
$4,721 |
|
|
$4,927 |
|
General
and administrative |
|
2,405 |
|
|
|
2,053 |
|
Total operating
expenses |
|
7,126 |
|
|
|
6,980 |
|
Loss from
operations |
|
(7,126 |
) |
|
|
(6,980 |
) |
Other income
(expense) |
|
|
Interest
expense, net |
|
(499 |
) |
|
|
(531 |
) |
Change in
fair value of warrants |
|
109 |
|
|
|
193 |
|
Loss before benefit
from income taxes |
|
(7,516 |
) |
|
|
(7,318 |
) |
Benefit from income
taxes |
|
— |
|
|
|
— |
|
Net (loss) income |
$(7,516 |
) |
|
$(7,318 |
) |
Net loss per share –
basic and diluted |
$(0.26 |
) |
|
$(0.27 |
) |
|
|
|
|
|
|
|
|
Weighted‑average shares
outstanding – basic and diluted |
|
28,769,361 |
|
|
|
26,826,223 |
|
Contact: Mary Coleman -- 609-356-1921
Agile Therapeutics (NASDAQ:AGRX)
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