PRINCETON, N.J., March 08, 2017 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's health specialty pharmaceutical company today reported financial results for the three months and year ended December 31, 2016 and provided a corporate update for the fourth quarter 2016.
Fourth quarter 2016 and other recent corporate developments include:
"We made significant progress during 2016 with the successful completion of our SECURE Phase 3 clinical trial, which we believe achieved positive top-line results. We continue to advance our plans to file our NDA resubmission for Twirla in the first half of this year. Once filed, we expect the FDA to complete its review within six months, with a potential approval by the end of 2017." said Al Altomari, Chairman and Chief Executive Officer of Agile. "Our priority moving forward is clear, give precedence to our Twirla development activities and prepare for a potential U.S. launch of Twirla. If approved, we look forward to providing women with a new contraceptive option that is designed to offer greater convenience and flexibility for women's busy lives."
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 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.
Certain 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, 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|
|Cash and cash equivalents||$||48,750||$||34,395|
|Total current assets||51,518||38,085|
|Property and equipment, net||12,330||12,318|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||5,402||$||5,040|
|Loan payable, current portion||5,104||2,336|
|Total current liabilities||10,678||7,782|
|Loan payable, long‑term||10,899||12,896|
|Additional paid‑in capital||235,754||194,468|
|Total stockholders' equity||42,289||29,743|
|Total liabilities and stockholders' equity||$||63,866||$||50,421|
|Agile Therapeutics, Inc.|
|Condensed Statements of Operations|
|(in thousands, except share and per share amounts)|
|Three Months Ended December 31,||Year Ended December 31,|
|Research and development||$||5,514||$||6,914||$||20,929||$||25,622|
|General and administrative||2,295||2,251||8,792||7,467|
|Total operating expenses||7,809||9,165||29,721||33,089|
Loss from operations
|Interest expense, net||(533||)||(551||)||(2,329||)||(2,072||)|
|Change in fair value of warrants||66||(155||)||234||(110||)|
|Loss on extinguishment of debt||--||--||--||(1,036||)|
|Loss before benefit from income taxes||(8,276||)||(9,871||)||(31,816||)||(36,307||)|
|Benefit from income taxes||3,075||5,972||3,075||5,972|
|Net loss per common share:|
|Basic and Diluted||$||(0.18||)||$||(0.17||)||$||(1.02||)||$||(1.38||)|
|Weighted-average shares outstanding:|
|Basic and Diluted||28,758,025||22,296,638||28,273,331||22,017,229|
Contact: Mary Coleman -- 609-356-1921