SAN DIEGO, July 30, 2019 /PRNewswire/ -- Evofem Biosciences, Inc., (NASDAQ: EVFM) will hold a conference call to discuss financial results and business highlights for the second quarter ended June 30, 2019, as follows:
Tuesday August 6, 2019
11:00 a.m. EDT
(866) 503-5561 (U.S. toll-free) or (253) 336-2965
Webcast (live and archived)
If participating by phone, please dial in approximately 10 minutes prior to the start of the call.
A slide presentation related to the call will be available via the aforementioned webcast link on the Evofem website https://evofem.investorroom.com/investors-home. Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.
A replay of the teleconference will be available approximately two hours after completion through Sunday, August 11, 2019, at (855) 859-2056 (U.S.) or (404) 537-3406 (International). The replay access code is 1953988. The archived webcast will be available via the aforementioned URLs for one year.
About Evofem Biosciences
Evofem Biosciences, Inc., is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health. Evofem Biosciences aims to advance the lives of women by developing innovative solutions, such as woman-controlled contraception and potential protection from certain sexually transmitted infections ("STIs"). The Company is leveraging its proprietary Multipurpose Vaginal pH Regulator (MVP-R™) platform to develop Amphora® (L-lactic acid, citric acid and potassium bitartrate) for birth control and prevention of urogenital acquisition of certain STIs. For more information, please visit www.evofem.com.
Amphora is an investigational MVP-R™ designed to regulate vaginal pH within the normal range of 3.5 to 4.5. This maintains an acidic environment which is inhospitable to sperm as well as certain viral and bacterial pathogens associated with sexually transmitted infections but is integral to the survival of healthy bacteria in the vagina. Amphora met the pre-specified primary endpoint of AMPOWER, the Phase 3 clinical trial evaluating this MVP-R for the prevention of pregnancy in approximately 1,400 women at 112 centers in the United States. In this clinical trial, Amphora had a favorable safety profile and was well tolerated. The Company plans to re-submit the Amphora New Drug Application (NDA) in the fourth quarter of 2019.
The Company expects to report top-line data in the fourth quarter of 2019 from AMPREVENCE, the double-blinded placebo-controlled Phase 2b clinical trial of Amphora to prevent urogenital acquisition of Chlamydia trachomatis (primary endpoint) and Neisseria gonorrhea (secondary endpoint) in women. This study enrolled approximately 850 women at approximately 50 centers in the United States. There are currently no therapeutics approved for the prevention of either STI.
Amphora® is a registered trademark and MVP-R™ is a trademark of Evofem Biosciences, Inc.
This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements related to the timing of the planned NDA Amphora re-submission for prevention of pregnancy, potential FDA approval of Amphora, and the potential commercial launch of Amphora, the anticipated results of the Phase 2b clinical trial of Amphora to prevent urogenital acquisition of Chlamydia trachomatis and Neisseria gonorrhea in women, and any expected completion date or general timing for this clinical trial. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. Important factors that could impair the value of Evofem Biosciences' assets and business are disclosed in the risk factors contained in its Annual Report on Form 10-K filed with the Securities and Exchange Commission and subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. Evofem Biosciences does not undertake any duty to update any forward-looking statement except as required by law.
Evofem Biosciences, Inc.
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SOURCE Evofem Biosciences, Inc.