Cash Expected to Fund Operations into Q2 2018
FDA Assigns Prescription Drug User Fee Act (PDUFA) Goal Date of December 26, 2017
PRINCETON, N.J., July 28, 2017 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq:AGRX), a women’s healthcare company today reported financial results for the three and six months ended June 30, 2017, and provided a corporate update for the second quarter 2017.
Second quarter 2017 and other recent corporate developments include:
- Twirla® Update – On June 27, 2017, the Company announced that it had resubmitted to the U.S. Food and Drug Administration (FDA) the New Drug Application (NDA) for Twirla, its investigational low-dose combined hormonal contraceptive patch (AG200-15). The Company resubmitted the NDA in response to a February 2013 Complete Response Letter (CRL) from the FDA. On July 27, 2017, the Company announced that the FDA had acknowledged the resubmitted NDA for Twirla as a complete response to the CRL, and provided a target Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2017.
- Securities Litigation – On July 13, 2017, the previously-disclosed complaints that were filed in January 2017 in the United States District Court for the District of New Jersey on behalf of a putative class of investors who purchased Company stock from March 9, 2016 through January 3, 2017 was dismissed with prejudice as to all defendants. The complaints alleged violations of the federal securities laws based on public statements made regarding the Company’s Phase 3 SECURE clinical trial and sought as damages an unspecified amount to be determined at trial. The Company has denied all allegations in the complaints. Following consolidation of the lawsuits and appointment of a lead plaintiff for the putative class, in June 2017, the lead plaintiff agreed to dismiss the consolidated case with prejudice voluntarily, without payment of any consideration and with each side bearing its own attorney fees and costs.
“We made excellent progress during the second quarter of 2017, most notably, with the successful submission and acceptance of the NDA resubmission for Twirla to the FDA. We are pleased with the assigned target PDUFA goal date of December 26, 2017. These accomplishments have set the stage for what we expect will be an important year for the company as we move closer to potentially commercializing our novel low-dose contraceptive patch and providing an important new contraceptive option for women,” said Al Altomari, Chairman and CEO of Agile. “We look forward to working with the FDA in moving Twirla through the regulatory review process and will continue to prudently manage our capital resources as we execute our business plan, which we expect will allow us to fund operations into the second quarter of 2018.”
Second Quarter Financial Results
- Cash and cash equivalents: As of June 30, 2017, Agile had $33.9 million of cash and cash equivalents compared to $48.8 million of cash and cash equivalents as of December 31, 2016. Based on the Company’s current business plan, the Company believes its cash and cash equivalents as of June 30, 2017, will be sufficient to meet its operating requirements into the second quarter of 2018. The Company’s current business plan assumes the FDA review of the Company’s resubmission of the Twirla NDA will be completed on the target PDUFA action date, and that pre-commercial activities and initiation of validation of its commercial manufacturing process will be coordinated with the timing of commercialization of Twirla, if approved. The Company will require additional capital for the commercial launch of Twirla, if approved, and for the development of its other product candidates. In the event of unforeseen changes to its planned timelines and business plan assumptions, as stated above, the Company still believes it has the ability to continue funding its operations into the second quarter of 2018 by postponing certain planned commercial and validation spending.
