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Evofem (NASDAQ: EVFM) 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’s lead product candidate, Amphora®, is a Multipurpose Vaginal pH Regulator (MVP-R)TM designed to regulate vaginal pH to 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.

On December 17, 2018, Evofem reported positive top-line results of AMPOWER, a Phase 3 clinical trial of Amphora for prevention of pregnancy. The top-line data met the pre-specified primary endpoint of this trial, and no serious treatment-related adverse events were reported. The Company expects:

  • To re-submit the Amphora New Drug Application (NDA) in H2 2019;
  • FDA decision on NDA in based on six-month review;
  • To commercialize Amphora in 2020 as the first and only hormone-free, woman-controlled, ‘only when she needs it’ birth control method (assuming approval). 

The Company plans to report top-line data in Q4 2019 from a double-blinded placebo-controlled Phase 2b clinical trial (AMPREVENCE) evaluating Amphora to prevent urogenital acquisition of Chlamydia trachomatis (primary endpoint) and Neisseria gonorrhea (secondary endpoint) in women. This clinical trial enrolled approximately 850 women at approximately 50 centers in the United States for a four-month interventional period and subsequent one-month follow-up period.

The CDC reported in August 2018 that rates of syphilis, gonorrhea and chlamydia climbed for the fourth consecutive year in the United States.  Nearly 2.3 million U.S. cases of these STDs were diagnosed in 2017 (preliminary data), an increase of over 200,000 cases over the prior year.1 

Evofem’s second product candidate is a MVP-RTM to reduce the recurrence of bacterial vaginosis (BV), which is caused by an imbalance of a woman’s vaginal bacteria, leading to unpleasant odor and abnormal vaginal discharge.  The Company recently completed a Phase 1 trial, and is currently designing a Phase 2b trial for this indication.

1Centers for Disease Control and Prevention (2018): STD Preliminary Data Accessed August 2018.

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PRESS RELEASES
Aug 26, 2019

Evofem Biosciences, Inc., (NASDAQ: EVFM) ("Evofem" or the "Company") today announced the last patient has completed her last visit in AMPREVENCE, the Phase 2b clinical trial evaluating the...

Aug 22, 2019

Evofem Biosciences, Inc., (NASDAQ: EVFM), a clinical-stage biopharmaceutical company, is set to present at two healthcare equity conferences in early September. Chief Executive Officer Saundra...

Aug 5, 2019

Evofem Biosciences, Inc., (NASDAQ: EVFM) ("Evofem" or the "Company"), a clinical stage biopharmaceutical company, today reported financial results for the three- and six- month period ended June...

Aug 5, 2019

Evofem Biosciences, Inc. (NASDAQ: EVFM) (Evofem), a clinical-stage biopharmaceutical company, today reported additional data from its Phase 3 'AMPOWER' clinical trial of Amphora® for the...

Jul 30, 2019

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: Date Tuesday...

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