Agile Therapeutics Reports Fourth Quarter and Full Year 2017 Financial Results

Current Business Plan Expected to Enable Cash to Fund Operations through the end of 2018

PRINCETON, N.J., March 12, 2018 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's healthcare company, today reported financial results for the three months and year ended December 31, 2017 and provided a corporate update.

Fourth quarter 2017 and other recent corporate developments include:

"We are focused on preparing for our upcoming meeting with the FDA to discuss the points identified in the CRL and a potential path forward for the approval of Twirla," stated Al Altomari, Chairman and Chief Executive Officer of Agile.  "We believe that Twirla, if approved, will provide women with a new contraceptive option in the form of a patch that is designed to deliver a low dose of estrogen and offer greater convenience for women."

Fourth Quarter Financial Results

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 has 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 We may occasionally disseminate material, nonpublic information on the company website.

Forward-Looking Statement
Certain information contained in this press release includes "forward-looking statements" 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," "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 our ability to adequately and timely respond to the deficiencies in the CRL issued by the FDA in December 2017 may be affected by whether any such response will be accepted by the FDA, our ability to resubmit and the timing of our resubmission of the NDA for Twirla, FDA acceptance and approval of the resubmitted NDA, the possibility that the FDA may require additional studies to address the concerns raised in the CRL (for example, if it is determined that the product adhesion concerns raised in the CRL are due to the design or formulation of the drug product, the FDA may recommend that we design a new transdermal system and conduct another clinical trial with the new transdermal system in a U.S. population, or even if the FDA agrees with our position regarding the relationship between the in vivo adhesion properties of Twirla and the efficacy and safety results from our SECURE clinical trial, the FDA may still determine that the need for a convenient, contraceptive patch and the demonstrated efficacy of Twirla, including the pearl index from our SECURE clinical trial, do not outweigh the potential risks associated with the product, and therefore are not sufficient to support the approval of Twirla), or whether other issues will arise that will negatively impact acceptance, review, and approval of Twirla by the FDA; our statements about the results of our clinical trial could be affected by the potential that there are changes in the interpretation of the data by the FDA (for example, the FDA continues to question the number of pregnancies included in our results and it may adjudicate additional pregnancies); our statements about our projected cash position could be affected by market factors, the inherent risks in our business, our ability to execute our operational and budget plans, if the FDA requires us to perform additional work or conduct additional studies prior to our resubmission of the NDA for Twirla, the fact that our existing cash and cash equivalents will not be sufficient to fund our current and planned operations beyond 2018, 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, and unforeseen events in our clinical and manufacturing development plans; our statements about the potential commercial opportunity could be affected by potential labeling restrictions, 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 our 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.

Source:  Agile Therapeutics

Contact:  Mary Coleman -- 609-356-1921

Agile Therapeutics, Inc.
Condensed Balance Sheets
(in thousands)
 December 31,

 December 31,

Current assets:  
Cash and cash equivalents$35,952  $48,750 
Prepaid expenses 762   2,768 
Total current assets 36,714   51,518 
Property and equipment, net 13,863   12,330 
Other assets 18   18 
Total assets$50,595  $63,866 
Liabilities and stockholders' equity       
Current liabilities:       
Accounts payable and accrued expenses$3,636  $5,694 
Loan payable, current portion 10,607   5,104 
Warrant liability 29   172 
Total current liabilities 14,272   10,970 
Loan payable, long‑term --   10,607 
Total liabilities 14,272   21,577 
Stockholders' equity  
Common stock 3   3 
Additional paid‑in capital 258,092   235,754 
Accumulated deficit (221,772)  (193,468)
Total stockholders' equity 36,323   42,289 
Total liabilities and stockholders' equity$50,595  $63,866 

Agile Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except share and per share amounts)
 Three Months Ended
December 31,
 Year Ended
 December 31,
  2017   2016   2017   2016 
Operating expenses:                 
Research and development$2,734  $5,514  $14,428  $20,929 
General and administrative 3,254   2,295   12,383   8,792 
Total operating expenses 5,988   7,809   26,811   29,721 
Loss from operations (5,988)  (7,809)  (26,811)  (29,721)
Other income (expense)    
Interest expense, net (314)  (533)  (1,636)  (2,329)
Change in fair value of warrants 62   66   143   234 
Loss before benefit from income taxes (6,240)  (8,276)  (28,304)  (31,816)
Benefit from income taxes    3,075      3,075 
Net loss$(6,240) $(5,201) $(28,304) $(28,741)
Net loss per share - basic and diluted$(0.18) $(0.18) $(0.91) $(1.02)
Weighted‑average shares outstanding — basic and diluted 34,183,772   28,758,025   30,940,831   28,273,331