Agile Therapeutics,Inc. (NASDAQ:AGRX) Files An 8-K Other Events

BMI (39.4% of subjects had a normal baseline weight (BMI of
under 25 kg/m2), 25.3% of subjects were overweight (BMI of at
least 25 kg/m2but less than 30 kg/m2), and 35.3% were obese
(BMI 30 kg/m2or more). When classified as obese (BMI 30 kg/m2or
more) or non-obese (BMI less than 30 kg/m2), 35.3% of subjects
were obese and 64.7% were non-obese).

Both new and experienced hormonal contraceptive users were
enrolled (9.4% of subjects were new users).

51.4% of subjects discontinued prematurely from the study and
the loss to follow-up rate was 11.3%, which is in line with
loss to follow-up rates observed in previous clinical trials of
combined hormonal products and substantially better than the
20% loss to follow-up rate observed in the Companys previous
Phase 3 trial.

The Pearl Index for the overall intent to treat population of
subjects 35 years of age and under was 4.80 with an upper-bound
of the 95% confidence interval of 6.06. As with all hormonal
contraceptive trials, the number of pregnancies included in the
Companys calculation of the Pearl Index is subject to review by
the FDA as part of its overall review of the NDA for Twirla.

Consistent with other recent hormonal contraceptive clinical
trials, including Ortho Evra and Quartette, and the FDAs 2015
meta-analysis on the effect of obesity on the effectiveness of
hormonal contraceptives, a relationship between obesity and
efficacy was observed among subjects 35 years of age and under:

*In its 2015 meta-analysis, the FDA examined the effect of
obesity on two populations: non-obese ( 30 kg/m2) and obese (
30 kg/m2). Non-obese includes subjects in the normal and
overweight categories.

The highest Pearl Index for a hormonal contraceptive product
approved by the FDA was 3.19 with an upper-bound of the 95%
confidence interval of 5.03. As with all products, ultimate
approvability of a hormonal contraceptive is based on a
risk/benefit assessment of the overall safety and efficacy
profile of a product, not only a specific Pearl Index. For
hormonal contraceptive trials, the FDA generally evaluates
efficacy results of each individual study in the unique context
of the study population and trial design.

Twirla was generally well tolerated and had an overall
favorable safety profile, consistent with publicly available
information relating to other low-dose combined hormonal
products. The most frequent hormone-related adverse events,
none of which were experienced by more than 5% of subjects,
were generally in line with those events observed in other low
dose combined hormonal products and included:

The percent of subjects reporting bleeding-related adverse
events was low, 1.8%, and only 1.4% of women discontinued for
bleeding issues.

Serious adverse events were observed in 1.7% of subjects. The
most common serious adverse events included deep vein
thrombosis, pulmonary embolism, gallbladder disease, ectopic
pregnancy and depression.

Overall, patch-related irritation and itching rates were low.
Of reported patches worn, 83% had no patch site irritation and
65% had no itching. Generally, reported irritation and itching
was mild. Severe itching or irritation were observed in 2.3%
and 1.5% of patches worn, respectively.

The patch adhesion profile was favorable with a low rate of
detachment. Of reported patches worn, the range of detachments
was 10% in cycle 1 and reduced to 2% by cycle 13.

The Company will also host a conference call to discuss the
top-line results from the SECURE clinical trial on January3,
2017.

Copies of the Companys press release and the conference call
presentation materials are attached hereto as Exhibits 99.1 and
99.2, respectively, and are hereby incorporated by reference
herein.

Risks Related to the Reported Results of
SECURE

The reported results of SECURE are based on
top-line data and may ultimately differ from actual results
once additional data are received and fully
evaluated.

The reported results of SECURE that we have publicly disclosed,
and that are discussed herein, consist of top-line data.
Top-line data are based on a preliminary analysis of currently
available efficacy and safety data, and therefore the reported
results, findings and conclusions related to SECURE are subject
to change following a comprehensive review of the more
extensive data that

we expect to receive related to SECURE. Top-line data are based
on important assumptions, estimations, calculations and
information currently available to us, and we have not received
or had an opportunity to fully and carefully evaluate all of
the data related to SECURE. As a result, the top-line results
of SECURE that we have reported may differ from future results,
or different conclusions or considerations may qualify such
results, once additional data have been received and fully
evaluated. In addition, third parties, including regulatory
agencies, may not accept or agree with our assumptions,
estimations, calculations or analyses or may interpret or weigh
the importance of data differently, which could impact the
potential for approval of Twirla, or if approved, the labeling
and commercial value of Twirla and our business in general. If
the top-line data that we have reported related to SECURE
differ from actual results, our ability to obtain approval for,
and commercialize, our products may be harmed, which could harm
our business, financial condition, operating results or
prospects.

The FDA may disagree with our interpretation of
clinical results obtained from SECURE, our results do not
guarantee support for a resubmission of our NDA or for
regulatory approval, and, even if the SECURE data are deemed to
be positive by the FDA, the FDA may disagree with other aspects
of the SECURE study and decline to approve Twirla for the
proposed indication.

We have reported positive top-line data from SECURE. However,
even if we believe that the data from SECURE are positive, the
FDA could determine that the data from SECURE were negative or
inconclusive or could reach a different conclusion than we did
on that same data. Negative or inconclusive results of a
clinical trial or difference of opinion could cause the FDA to
decline to approve our application or require us to repeat the
trial or conduct additional clinical trials prior to obtaining
approval for commercialization, and there is no guarantee that
additional trials would achieve positive results to the
satisfaction of the FDA or that the FDA will agree with our
interpretation of the results. Any such determination by the
FDA would delay the timing of our commercialization plan for
Twirla or prevent its further development, or the further
development of our other product candidates, and adversely
affect our business operations. Additionally, the FDA may
provide review commentary at any time during the resubmission
and review process which could delay the review timeline,
adversely affect the review process, or even prevent the
approval of Twirla, any of which would adversely affect our
business. We may not be able to appropriately remedy issues
that the FDA may raise in its review of our NDA resubmission,
and we may not have sufficient time or financial resources to
conduct future activities to remediate issues raised by the
FDA.

There is no guarantee that the data obtained from SECURE will
be supportive of, or guarantee, an NDA resubmission, or result
in our successfully obtaining FDA approval of Twirla in a
timely fashion and for a commercially viable indication, if at
all. For example, the FDA could determine that the trial did
not meet its objectives or the FDA could still have concerns
regarding the conduct of the SECURE study, including regarding
discontinuance of subjects from the trial. At any future point
in time, the FDA could require us to complete further clinical
or preclinical trials, or take other actions which could delay
or preclude any NDA resubmission or approval of the NDA and
could require us to obtain significant additional funding.
There is no guarantee such funding would be available to us on
favorable terms, if at all, nor is there any guarantee that FDA
would consider any additional information complete or
sufficient to support approval. If the Twirla NDA is
resubmitted, the FDA may hold an advisory committee meeting to
obtain committee input on the

safety and efficacy of Twirla. Typically, advisory committees
will provide responses to specific questions asked by the FDA,
including the committees view on the approvability of the
product candidate under review. Advisory committee decisions
are not binding but an adverse decision at the advisory
committee may have a negative impact on the regulatory review
of Twirla. Additionally, we may choose to engage in the dispute
resolution process with the FDA if we do not receive approval,
which could extend the timeline for any potential approval.

Further, if we are able to resubmit an NDA for Twirla with the
clinical data from SECURE, there is no guarantee that such data
will be deemed sufficient by the FDA. While we designed the
protocols for SECURE to address the issues raised in the CRL,
there is no guarantee that the FDA will deem such protocols or
results from the study sufficient to address those issues when
they are formally reviewed as a part of an NDA resubmission or
to demonstrate safety and efficacy to the satisfaction of the
FDA. The FDA has significant discretion in the review process,
and we cannot predict whether the FDA will agree with our
conclusions regarding the results of the SECURE trial,
including whether our data are reliable and generalizable. For
example, the FDA may disagree with our calculations relating to
the number of pregnancies occurring on study, or may view the
SECURE data as insufficient to demonstrate a favorable
benefit/risk profile for approval for the proposed indication.
In addition, based on top-line data, the Pearl Index for the
overall intent to treat population of subjects 35 years of age
and under was 4.80 with an upper-bound of the 95% confidence
interval of 6.06, but in the obese subpopulation of subjects 35
years of age and under, the Pearl Index was 6.42 with an
upper-bound of the 95% confidence interval of 8.88. If we were
to exclude the top-line data on the obese subpopulation, our
Pearl Index for non-obese patients was 3.94 with an upper-bound
of the 95% confidence interval of 5.35. The highest Pearl Index
for a hormonal contraceptive product approved by the FDA was
3.19 with an upper-bound of the 95% confidence interval of
5.03. Although ultimate approvability of a hormonal
contraceptive is based on a risk/benefit assessment of the
overall safety and efficacy profile of a product, not only a
specific Pearl Index, the FDA could conclude that our Pearl
Index for either the overall study population or only the
non-obese study population is too high to demonstrate efficacy
and an adequate risk/benefit profile, and as such, the FDA
could decline to approve Twirla on this or any other basis.
Further, the FDA may not agree with our analysis of the
relationship between obesity and efficacy for Twirla and the
FDA may interpret our overall data differently than we do and
may decline to approve Twirla on this or any other basis.

Moreover, even if we obtain approval of Twirla, any such
approval might significantly limit the approved indications for
use, including by limiting the approved label for use by more
limited patient populations than we propose, require that
precautions, contraindications or warnings be included on the
product labeling, including black box warnings, require
expensive and time-consuming post-approval clinical studies,
risk evaluation and mitigation strategies, or REMS, or
surveillance as conditions of approval, or, through the product
label, the approval may limit the claims that we may make,
which may impede the successful commercialization of Twirla.
For example, the FDA may deem the higher Pearl Index in the
obese subpopulation to warrant a labeling limitation or warning
for such subpopulation, which could limit the commercial
potential of the product, if approved. Moreover, because we did
not conduct any head-to-head studies of Twirla against Ortho
Evra, we will not be able to make direct comparative claims
regarding the safety, efficacy or pharmacokinetics of Twirla
and Ortho Evra or its generic version, Xulane.

We are substantially dependent on the commercial
success of Twirla.

If we obtain FDA approval of Twirla, Twirla will be the first
product that we commercialize. The rest of our pipeline of
products are in earlier stages of clinical development and will
require additional clinical and product development and funding
in order to advance towards commercialization, which could take
considerable time. If Twirla is not approved, our ability to
advance our pipeline would be significantly adversely affected.
Our ability to generate revenues

and become profitable will depend in large part on the
commercial success of Twirla. If Twirla or any other product
that we commercialize in the future does not gain an adequate
level of acceptance among physicians, patients and third
parties, we may not generate significant product revenues or
become profitable. Market acceptance of Twirla, and any other
product that we commercialize, by physicians, patients and
third party payors will depend on a number of factors, some of
which are beyond our control, including:

Efficacy, safety and other potential advantages of our product
candidates in relation to alternative treatments;

Relative convenience and ease of administration of our product
candidates;

Availability of adequate coverage or reimbursement of our
product candidates by third parties, such as insurance
companies and other payors, and by government healthcare
programs, including Medicare, Medicaid and state health
insurance exchanges;

Prevalence and severity of adverse events associated with our
product candidates;

Cost of our product candidates in relation to alternative
treatments, including generic products;

Extent and strength of our third-party manufacturer and
supplier support;

Extent and strength of our marketing and distribution support;

Limitations or warnings contained in our products FDA approved
labeling; and

Distribution and use restrictions imposed by the FDA or to
which we agree as part of a mandatory REMS or voluntary risk
management plan.

For example, if Twirla is approved by the FDA, physicians and
patients may not be immediately receptive to a transdermal
contraceptive system, as opposed to a pill or any other method,
and may be slow to adopt it as an accepted treatment for the
prevention of pregnancy. In addition, even though we believe
Twirla has the potential to offer significant advantages over
other treatment options, because no head-to-head trials
comparing Twirla to the competing approved patch product have
been conducted, the prescribing information approved by the FDA
may not contain claims that Twirla is safer or more effective
than the currently approved patch product, or other claims that
may be necessary for successful marketing of Twirla.
Accordingly, we will not be permitted to promote Twirla, if
approved, for any comparative advantages to the currently
marketed contraceptive patch. The availability of numerous
inexpensive generic forms of contraceptive products may also
limit acceptance of Twirla among physicians, patients and third
party payors. If Twirla does not achieve an adequate level of
acceptance among physicians, patients and third party payors,
we may not generate significant product revenues or become
profitable.

Even if we obtain marketing approval for Twirla or
other product candidates, we will be subject to ongoing
obligations and continued regulatory review, which may result
in significant additional expense. Additionally, Twirla or
other product candidates could be subject to labeling and other
restrictions, including withdrawal from the market, and we may
be subject to penalties if we fail to comply with regulatory
requirements or if we experience unanticipated
problems.

Even if we obtain U.S. regulatory approval of Twirla or other
product candidates, the FDA may still impose significant
restrictions on their indicated uses, including more limited
patient populations, require that precautions,
contraindications, or warnings be included on the product
labeling, including black box warnings, or impose ongoing
requirements for potentially costly and time-consuming
post-approval studies, including Phase 4 clinical trials, and
post-market surveillance to monitor safety and efficacy. Claims
that we may make may also be restricted through our approved
labeling. For example, based on the SECURE top-line data, the
Pearl Index for the overall intent to treat population of
subjects 35 years of age and under was 4.80 with an upper-bound
of the 95% confidence interval of 6.06, but in the obese
subpopulation of subjects 35 years of age and under, the Pearl
Index was 6.42 with an upper-bound of the 95% confidence
interval of 8.88. The highest Pearl Index for a hormonal
contraceptive product approved by the FDA was 3.19 with an
upper-bound of the 95% confidence interval of 5.03. Although
ultimate approvability of a hormonal contraceptive is based on
a risk/benefit assessment of the overall safety and efficacy
profile of a product, not only a specific Pearl Index, the FDA
could conclude that the Pearl Index in the obese subpopulation
is too high to demonstrate efficacy and an adequate
risk/benefit profile. As such, even if we receive approval of
Twirla, the FDA could impose restrictions on use by the obese
subpopulation or otherwise require labeling limitations or
warnings for such subpopulation, which could limit the
commercial potential of the product, if approved.

If approved, Twirla and our other product candidates will also
be subject to ongoing regulatory requirements governing the
manufacturing, labeling, packaging, storage, distribution,
import, export, safety surveillance, advertising, marketing
promotion, recordkeeping, reporting of adverse events and other
post-market information, and further development. These
requirements include registration with the FDA, listing of our
drug products, payment of annual fees, as well as continued
compliance with current Good Clinical Practices (cGCPs) for any
clinical trials that we conduct post approval. Application
holders must notify the FDA, and depending on the nature of the
change, obtain FDA pre-approval for product manufacturing
changes. In addition, manufacturers of drug products and their
facilities are subject to continual review and periodic
inspections by the FDA and other regulatory authorities for
compliance with current Good Manufacturing Practices (cGMP)
requirements relating to quality control, quality assurance and
corresponding maintenance of records and documents. If we are
found to be noncompliant with applicable requirements, the FDA
and other government authorities may issue a Warning Letter or
Untitled Letter, or take other regulatory action such as a
product seizure and detention, withdrawal of product approval,
request for a recall, refusal to allow the import or export of
the product, criminal or civil penalties, injunction against or
restriction of manufacture or distribution, consent decrees,
disgorgement, restitution, clinical holds or terminations,
exclusion from federal healthcare programs, corporate integrity
agreements, or imprisonment.

Forward-Looking Statements

This Current Report contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this Current Report that do
not relate to matters of historical fact should be considered
forward-looking statements, including without limitation,
expectations regarding the clinical significance and regulatory
review of top-line data from our Phase 3 SECURE study and the
timing of resubmission of our NDA for Twirla.

The Company 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 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 Companys
Annual Report on Form10-K and our Quarterly Reports on
Form10-Q. You are cautioned not to place undue reliance on
these forward-looking statements, which are made only as of the
date of this Current Report on Form8-K. We undertake no
obligation to publicly update such forward-looking statements
to reflect subsequent events or circumstances.

Item 9.01. Financial Statements and
Exhibits.

(d) Exhibits.