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Agile Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results
Cash Expected to
Company plans to resubmit Twirla NDA in second quarter of 2019
Fourth quarter 2018 and other recent corporate developments:
- Formal Dispute Resolution Ended: As previously announced, in
October 2018, the U.S. Food and Drug Administration’s ( FDA) Office of New Drugs(OND) formally denied the Company’s formal dispute resolution (FDR) appeal and provided an alternative path forward for resubmission of the new drug application (NDA) for Twirla, the Company’s lead product candidate. In its FDR decision, the OND recommended that the Company conduct a comparative wear study to evaluate whether Twirla demonstrates a generally similar adhesion performance to Xulane®, the generic version of the previously marketed Ortho Evra® contraceptive patch, a product the FDAconsiders to have acceptable adhesion.
- 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. The Company had previously reported that in its December 2018meeting 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.
- NDA Resubmission Plans: The Company plans to resubmit its Twirla NDA in the second quarter of 2019. The planned resubmission is intended to be a complete response to the complete response letter the Company received from the
FDAin 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.
March 4, 2019, the Company completed the sale of approximately 8.4 million shares of common stock at $0.93per share to an institutional accredited investor through a private placement, resulting in gross proceeds of approximately $7.8 million.
“We are pleased to have completed our private placement and appreciate the support from our new investor,” said
Fourth Quarter Financial Results
- Cash and cash equivalents: As of
December 31, 2018, Agile had $7.8 millionof cash and cash equivalents compared to $35.9 millionof cash and cash equivalents as of December 31, 2017. The Company believes its cash and cash equivalents as of December 31, 2018along with the proceeds from its private placement completed in March 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
$1.9 millionfor the quarter ended December 31, 2018and $9.8 millionfor the year ended December 31, 2018, compared to $2.7 millionand $14.4 millionfor the comparable periods in 2017. 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.
- General and administrative (G&A) expenses: G&A expenses were
$1.6 millionfor the quarter ended December 31, 2018and $8.7 millionfor the year ended December 31, 2018, compared to $3.3 millionand $12.4 millionfor the comparable periods in 2017. The decrease in G&A expenses was primarily due to the suspension of pre-commercialization activities as a result of the receipt of the 2017 CRL.
- Net loss: Net loss was
$3.8 million, or $0.11per share, for the quarter ended December 31, 2018, compared to a net loss of $6.2 million, or $0.18per share, for the quarter ended December 31, 2017. Net loss for the year ended December 31, 2018was $19.8 million, or $0.58per share, compared to a net loss of $28.3 millionor $0.91per share for the year ended December 31, 2017.
- Shares Outstanding: At
December 31, 2018, Agile had 34,377,329 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 a complete response letter (“CRL”) from the
Xulane® is a registered trademark of
Certain 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 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
Contact: Investor Relations -- 609-683-1880
Condensed Balance Sheets
|Cash and cash equivalents||$7,851||35,952|
|Total current assets||8,458||36,714|
|Property and equipment, net||13,916||13,863|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$2,218||3,636|
|Loan payable, current portion||-||10,607|
|Additional paid‑in capital||261,722||258,092|
|Total stockholders’ equity||20,174||36,323|
|Total liabilities and stockholders’ equity||$22,392||$50,595|
Agile Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except share and per share amounts)
| Three Months Ended
| Year Ended
|Research and development||$1,856||$2,734||$9,777||$14,428|
|General and administrative||1,567||3,254||8,739||12,383|
|Total operating expenses||3,727||5,988||19,535||26,811|
|Loss from operations||(3,727||)||(5,988||)||(19,535||)||(26,811||)|
|Other income (expense)|
|Change in fair value of warrants||—||62||29||143|
|Loss before benefit from income taxes||(3,810||)||(6,240||)||(20,256||)||(28,304||)|
|Benefit from income taxes||-||-||477||-|
|Net loss per share - basic and diluted||$(0.11||)||$(0.18||)||$(0.58||)||$(0.91||)|
|Weighted‑average shares outstanding|
|–basic and diluted||34,377,329||34,183,772||34,315,931||30,940,831|
Source: Agile Therapeutics, Inc.