Agile Therapeutics,Inc. (NASDAQ:AGRX) Files An 8-K Results of Operations and Financial Condition
Item 8.01 Results of Operations and Financial Condition.
As discussed below, in connection with its participation in the 37thAnnual J.P. Morgan Healthcare Conference in San Francisco, California beginning on January7, 2019, Agile Therapeutics,Inc. (the “Company”) updated its corporate presentation to include disclosure that the Company had $7.8 million of cash and cash equivalents (unaudited) as of December31, 2018.
Because the Company’s financial statements for the year ended December31, 2018 have not yet been finalized or audited, the preliminary statement of the Company’s cash and cash equivalents as of December31, 2018 in this Item 8.01 is subject to change, and the Company’s actual cash and cash equivalents as of the end of this period may differ materially from this preliminary estimate. Accordingly, you should not place undue reliance on this preliminary estimate.
Item 8.01.Other Events
Beginning on January7, 2019, the Company will participate in the 37thAnnual J.P. Morgan Healthcare Conference in San Francisco, California. The Company has updated its corporate presentation that it intends to use in connection with its presentation at the Biotech Showcase 2019 on Tuesday January8, 2019 at 10:00 a.m.Pacific Time and in meetings with investors. The updates primarily include disclosure regarding the Company’s cash and cash equivalents as of December31, 2018 and an update regarding the Company’s regulatory path forward for Twirla®, including planned timelines for completion of a comparative wear study with Xulane®, resubmission of the Twirla NDA, a likely U.S. Food and Drug Administration advisory committee on Twirla’s efficacy and benefit/risk profile, and for Twirla’s potential approval.
A copy of the Company’s corporate presentation is attached hereto as Exhibit99.1 and is hereby incorporated by reference herein.
Xulane®is a registered trademark of Mylan N.V.
Item 8.01. Financial Statements and Exhibits.
Agile Therapeutics,Inc. Presentation
AGILE THERAPEUTICS INC Exhibit
EX-99.1 2 a19-1052_2ex99d1.htm EX-99.1 Exhibit 99.1 Low-dose,…
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About Agile Therapeutics,Inc. (NASDAQ:AGRX)
Agile Therapeutics, Inc. is a women’s health specialty pharmaceutical company. The Company is focused in the development and commercialization of prescription contraceptive products. The Company has developed a transdermal patch technology, called Skinfusion. The Company’s lead product candidate is Twirla, also known as AG200-15, is a combined hormonal contraceptive (CHC) patch. In addition to Twirla, the Company is developing a pipeline of other new transdermal contraceptive products, including AG200-ER, which is a regimen designed to allow a woman to extend the length of her cycle; AG200-SP, which is a regimen designed to provide a shortened hormone-free interval, and AG890, which is a progestin-only contraceptive patch intended for use by women who are unable or unwilling to take estrogen. Each of its product candidates utilizes its Skinfusion technology designed to deliver contraceptive-levels of hormones to the blood stream through the skin over a seven-day period.