Company Plans to Resubmit Twirla® NDA in
Second Quarter of 2019
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today reported financial results for the three months
ended March 31, 2019 and provided a corporate update.
First quarter 2019 and other recent
corporate developments:
Twirla® Update
- Comparative Wear Trial Completed: On February 11, 2019, the
Company announced topline results of a comparative wear study of
Twirla® and Xulane®, which demonstrated that Twirla was
statistically non-inferior to Xulane, a product the U.S. Food and
Drug Administration (FDA) considers to have adequate
adhesion. The Company had previously reported that in its
December 2018 meeting with FDA’s Division of Bone, Reproductive and
Urologic Products, (DBRUP), DBRUP agreed that Twirla would show
adequate adhesion if it demonstrated statistical non-inferiority to
Xulane in this study.
- In Vivo Adhesion Data from Two Phase 1 Studies Presented: An
abstract presenting data from two Phase 1 in vivo wear studies on
the adhesion of Twirla was selected for a poster presentation
during the 2nd Annual Formulation & Drug Delivery USA
Congress. The poster, titled “Results of Two Phase 1 Clinical
Trials on the Adhesion Profile of AG200-15, An Investigational
Transdermal Contraceptive Delivery System,” was presented by lead
author Terrance Ocheltree, PhD, a former FDA Reviewer and Director
of the Division of New Drug Quality Assessment II at the FDA.
- New Drug Application (NDA) Resubmission Plans: The Company
plans to resubmit its Twirla NDA in the second quarter of 2019 and
seek approval of the NDA in the fourth quarter of 2019. The
planned resubmission is intended to be a complete response to the
complete response letter the Company received from the FDA in
December 2017 (2017 CRL) and will include the results from the
comparative wear study, additional information on the Company’s
manufacturing process, and other analyses responding to the 2017
CRL.
Financing Update
- On March 4, 2019, the Company completed the sale of
approximately 8.4 million shares of common stock at $0.93 per share
to an institutional accredited investor through a private
placement, resulting in net proceeds of approximately $7.8
million.
“We are pleased with the progress we made on our
business plan during the first quarter of 2019,” said Al Altomari,
Chairman and Chief Executive Officer of Agile. “Between the
successful completion of the comparative wear study requested by
the FDA and funds raised through our private placement of common
stock, we believe we can execute our regulatory strategy to seek
the approval of Twirla. We continue to believe that Twirla, if
approved, will provide women with an important contraception option
they do not currently have – a once-weekly contraceptive patch
designed to deliver a low dose of estrogen.”
First Quarter Financial
Results
- Cash and cash
equivalents: As of March 31, 2019, Agile had $11.6
million of cash and cash equivalents compared to $7.8 million of
cash and cash equivalents as of December 31, 2018. The
Company believes its cash and cash equivalents as of March 31, 2019
will be sufficient to meet its projected operating requirements
into the fourth quarter of 2019. The Company will require
additional capital to fund operating needs for the remainder of the
fourth quarter of 2019 and beyond, which will include, among other
items, the completion of its commercial plan for Twirla, if
approved, which primarily includes validation of the commercial
manufacturing process and the commercial launch, and advancing the
development of its other potential product candidates.
- Research and development
(R&D) expenses: R&D expenses were $2.9
million for the quarter ended March 31, 2019, compared to $4.0
million for the comparable period in 2018. The decrease in R&D
expenses was primarily due to a decrease in manufacturing and
commercialization expenses reflecting reduced activity associated
with the scale-up process and the on-going qualification process of
the commercial manufacturing equipment primarily as a result of the
receipt of the 2017 CRL offset, in part, by the cost of the
comparative wear study that was initiated and completed in the
first quarter of 2019.
- General and administrative
(G&A) expenses: G&A expenses were $1.8
million for the quarter ended March 31, 2019, compared to $3.1
million for the comparable period in 2018. The decrease in
G&A expenses was primarily due to the suspension of
pre-commercialization activities as well as decreased personnel
costs as a result of the receipt of the 2017 CRL.
- Net loss:
Net loss was $4.7 million, or $0.13 per share, for the quarter
ended March 31, 2019, compared to a net loss of $6.8 million, or
$0.20 per share, for the quarter ended March 31, 2018.
- Shares
Outstanding: At March 31, 2019, Agile had 43,615,257
shares of common stock outstanding.
About Twirla® (AG200-15)Twirla
(ethinyl estradiol and levonorgestrel transdermal system) or
AG200-15 is an investigational low-dose, once-weekly combined
hormonal contraceptive (CHC) patch that contains the active
ingredients ethinyl estradiol (EE), a type of estrogen, and
levonorgestrel (LNG), a type of progestin. Twirla is designed to be
applied once weekly for three weeks, followed by a week without a
patch. The Company has completed its Phase 3 clinical trials
of Twirla and is pursuing regulatory approval in the U.S. Agile
received the 2017 CRL from the FDA relating to the NDA for
Twirla. The Company plans to resubmit the Twirla NDA in the
second quarter of 2019.
Xulane® is a registered trademark of Mylan N.V., and Ortho Evra®
is a registered trademark of Johnson & Johnson.
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 an
investigational low-dose, non-daily prescription contraceptive.
Twirla is based on our proprietary transdermal patch technology,
called Skinfusion®, which is designed to allow drug delivery
through the skin. For more information, please visit the company
website at www.agiletherapeutics.com. The Company may occasionally
disseminate material, nonpublic information on the Company’s
website.
Forward-Looking
StatementCertain information contained in this press
release includes “forward-looking statements,” within the meaning
of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended,
related to our regulatory submissions and projected cash position.
We may, in some cases use terms such as “predicts,” “believes,”
“potential,” “continue,” “anticipates,” “estimates,” “expects,”
“plans,” “intends,” “may,” “could,” “might,” “likely,” “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, including
statements regarding the fact that our existing cash and cash
equivalents likely will not be sufficient to fund our current and
planned operations beyond the fourth quarter of 2019, which raises
substantial doubt about our ability to continue as a going concern,
and which, in turn, may create negative reactions to the price of
our common stock, making it more difficult to obtain financing in
the future, our expectations about Twirla and its NDA, and the use
of the net proceeds of our recently completed private
placement. 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. These
forward looking statements are subject to risks and uncertainties
including risks related to our available cash and our ability to
obtain additional funding to fund our business plan without delay
and to continue as a going concern, our ability to adequately and
timely respond to the deficiencies in the second Twirla CRL issued
by the FDA on December 21, 2017, the potential that the FDA
determines that our data do not support resubmission or approval of
Twirla NDA and requires us to conduct additional studies or
reformulate Twirla to address the concerns raised in the 2017 CRL,
our ability to resubmit the Twirla NDA and obtain and maintain
regulatory approval of our product candidates, and the labeling
under any approval we may obtain, our ability to obtain a favorable
Advisory Committee vote in the likely event the FDA requires an
Advisory Committee to review the benefit and risk profile of
Twirla, the accuracy of our estimates regarding expenses, future
revenues, capital requirements and needs for additional financing,
our third-party manufacturer, Corium International, Inc.’s (Corium)
inability to complete any work or provide any data and other
information necessary to support the resubmission and approval of
our Twirla NDA, our ability along with Corium to complete
successfully the scale-up of the commercial manufacturing process
for Twirla, including the qualification and validation of equipment
related to the expansion of Corium's manufacturing facility and to
pass a likely FDA pre-approval inspection, the performance and
financial condition of Corium or any of the suppliers to our
third-party manufacturer, the success and timing of our clinical
trials or other studies, our ability to retain key employees,
regulatory and legislative developments in the United States and
foreign countries, which could include, among other things, a
government shutdown, our plans to commercialize Twirla and develop
our other potential product candidates, the size and growth of the
potential markets for our product candidates and our ability to
serve those markets, the rate and degree of market acceptance of
any of our product candidates, our ability to obtain and maintain
intellectual property protection for our product candidates, the
successful development of our sales and marketing capabilities, our
inability to timely obtain from our third-party manufacturer,
Corium, sufficient quantities or quality of our product candidates
or other materials required for a clinical trial or other tests and
studies, our ability to successfully implement our strategy and the
other risks set forth in our filings with the U.S. Securities and
Exchange Commission, including our Annual Report on Form 10-K and
our Quarterly Reports on Form 10-Q. For all these reasons,
actual results and developments could be materially different from
those expressed in or implied by our forward-looking statements.
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.
Source: Agile Therapeutics
Contact: Investor Relations --
609-683-1880
Agile Therapeutics,
Inc.Condensed Balance Sheets
(in
thousands) (Unaudited)
|
March 31,2019 |
|
December 31, 2018 |
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$11,560 |
|
|
$7,851 |
|
Prepaid expenses |
|
378 |
|
|
|
607 |
|
Total current assets |
|
11,938 |
|
|
|
8,458 |
|
Property and equipment, net |
|
13,911 |
|
|
|
13,916 |
|
Right of use and other assets |
|
284 |
|
|
|
18 |
|
Total assets |
$26,133 |
|
|
$22,392 |
|
Liabilities and stockholders’
equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
Accounts payable and accrued
expenses |
$1,183 |
|
|
$2,218 |
|
Lease liability, current
portion |
|
157 |
|
|
|
- |
|
Total current liabilities |
|
1,340 |
|
|
|
2,218 |
|
Lease liability, long-term |
|
128 |
|
|
|
- |
|
|
|
|
Stockholders’ equity |
|
|
Common stock |
|
4 |
|
|
|
3 |
|
Additional paid‑in capital |
|
271,094 |
|
|
|
261,722 |
|
Accumulated deficit |
|
(246,433 |
) |
|
|
(241,551 |
) |
Total stockholders’ equity |
|
24,665 |
|
|
|
20,174 |
|
Total liabilities and stockholders’ equity |
$26,133 |
|
|
$22,392 |
|
|
|
|
|
|
|
|
|
Agile
Therapeutics, Inc.Condensed Statements of
Operations
(in thousands, except share and per share
amounts) (Unaudited)
|
Three Months Ended March
31, |
|
2019 |
|
2018 |
Operating expenses: |
|
|
|
|
|
Research and development |
$2,881 |
|
|
$3,960 |
|
General and
administrative |
|
1,826 |
|
|
|
3,086 |
|
Total operating expenses |
|
4,707 |
|
|
|
7,046 |
|
Loss from operations |
|
(4,707 |
) |
|
|
(7,046 |
) |
Other income (expense) |
|
|
Interest expense |
|
— |
|
|
|
(368 |
) |
Interest income |
|
38 |
|
|
|
97 |
|
Change in fair value of
warrants |
|
— |
|
|
|
7 |
|
Loss before benefit from income taxes |
|
(4,669 |
) |
|
|
(7,310 |
) |
Benefit from income taxes |
|
— |
|
|
|
477 |
|
Net loss |
$(4,669 |
) |
|
$(6,833 |
) |
Net loss per share - basic and diluted |
$(0.13 |
) |
|
$(0.20 |
) |
|
|
|
|
|
|
|
|
Weighted‑average shares outstanding –basic and
diluted |
|
37,308,232 |
|
|
|
34,229,162 |
|
|
|
|
|
|
|
|
|
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