Top-Line Data Expected in Early January 2017; Resubmission Planned for First Half 2017 Cash Expected to Fund Operations Through the End of 2017 PRINCETON, N.J., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's health specialty pharmaceutical company, today announced completion of all final subject visits for its Twirla ® Phase 3 SECURE clinical trial, reported financial results for the three and nine months ended September 30, 2016, and provided a corporate update for the third quarter 2016. "Completion of all subject visits in our SECURE clinical trial is a significant milestone in the development of Twirla," said Elizabeth Garner, M.D., M.P.H., Chief Medical Officer of Agile. "We can now move forward with data verification and database lock activities, which we anticipate being completed by the end of December 2016. We will then proceed with initial data analysis and expect to announce top-line data in early January 2017. We believe we have conducted a well-run trial focused on quality and the key metrics the U.S. Food and Drug Administration (FDA) has indicated would be most important in their assessment of SECURE. We look forward to submitting a comprehensive package of reliable data that we believe can respond to the FDA's questions as well as establish the safety and efficacy profile for Twirla. We would like to thank our investigators and their staff, our partners and, most importantly, the women who participated in SECURE for helping us conduct such a rigorous study." SECURE is a multicenter, single-arm, open-label Phase 3 clinical trial evaluating the safety, efficacy and tolerability of Twirla in 2032 healthy women aged 18 and over at 102 experienced investigative sites across the United States. The clinical trial was designed in consultation with the FDA in response to their 2013 complete response letter (CRL). The FDA recommended that the Company conduct a clinical trial that would address prior conduct and quality issues and demonstrate efficacy as measured by an acceptable pearl index and related confidence interval in a representative sample of U.S. women with respect to key demographic criteria including contraceptive user status, age, race, ethnicity, and body mass index (BMI). Twirla contains the active ingredients ethinyl estradiol and levonorgestrel, both of which have an established history of efficacy and safety in currently marketed low-dose combination oral contraceptives. The patch is intended to be applied once weekly for three weeks followed by a patch-free week, and is designed to promote user compliance.
Third quarter 2016 and other recent corporate developments include:
- In August 2016, the Company amended its loan agreement with Hercules Capital, Inc. The amendment, among other things, extends the period during which the Company can draw the second tranche of $8.5 million of its term loan until March 31, 2017 and also extends the interest-only payment period on its first tranche of the term loan to January 31, 2017.
- In October 2016, the Company's Board of Directors appointed Al Altomari, the Company's President and Chief Executive Officer, as Chairman of the Board and Abhijeet Lele as the Lead Independent Director of the Board.
- Cash and cash equivalents: As of September 30, 2016, Agile had $51.7 million of cash and cash equivalents compared to $34.4 million of cash and cash equivalents as of December 31, 2015. Based on its current business plan, Agile believes its cash and cash equivalents will be sufficient to meet its operating requirements through the end of 2017.
- Research and development (R&D) expenses: R&D expenses were $4.9 million for the quarter ended September 30, 2016, compared to $7.2 million for the comparable period in 2015. The decrease in R&D expense was primarily due to decreased investigator and clinical site costs associated with the ongoing Phase 3 clinical trial for Twirla.
- General and administrative (G&A) expenses: G&A expenses were $2.2 million for the quarter ended September 30, 2016, compared to $1.8 million for the comparable period in 2015. The increase in G&A expenses was primarily due to increased stock-based compensation expense associated with 2016 stock option grants as well as increased legal costs, search fees and consulting expense.
- Net loss: Net loss was $7.8 million, or $0.27 per basic share for the quarter ended September 30, 2016, compared to a net loss of $9.4 million, or $0.42 per basic share for the quarter ended September 30, 2015.
- Shares Outstanding: At September 30, 2016, Agile had 28,757,719 shares of common stock outstanding.
|Agile Therapeutics, Inc.|
|Condensed Balance Sheets|
|September 30, 2016||December 31, 2015|
|Cash and cash equivalents||$||51,670||$||34,395|
|Total current assets||54,764||38,085|
|Property and equipment, net||12,330||12,318|
|Other assets, long-term||18||18|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||4,644||$||5,040|
|Loan payable, current portion||3,486||2,336|
|Total current liabilities||8,368||7,782|
|Loan payable, long-term||12,077||12,896|
|Additional paid-in capital||234,931||194,468|
|Total stockholders' equity||46,667||29,743|
|Total liabilities and stockholders' equity||$||67,112||$||50,421|
|Agile Therapeutics, Inc.|
|Condensed Statements of Operations|
|(in thousands, except share and per share amounts)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||$||4,911||$||7,162||$||15,415||$||18,709|
|General and administrative||2,180||1,803||6,497||5,215|
|Total operating expenses||7,091||8,965||21,912||23,924|
|Loss from operations||(7,091||)||(8,965||)||(21,912||)||(23,924||)|
|Interest expense, net||(751||)||(550||)||(1,796||)||(1,521||)|
|Change in fair value of warrants||38||104||168||45|
|Loss on extinguishment of debt||--||--||--||(1,036||)|
|Loss before benefit from income taxes||(7,804||)||(9,411||)||(23,540||)||(26,436||)|
|Benefit from income taxes||--||--||--||--|
|Net loss per common share:|
|Basic and Diluted||$||(0.27||)||$||(0.42||)||$||(0.84||)||$||(1.21||)|
|Weighted-average shares outstanding:|
|Basic and Diluted||28,754,458||22,272,777||28,110,587||21,923,070|
Contact: Mary Coleman -- 609-356-1921