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Will Second Time Prove A Charm For Evofem?

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Shares of Evofem Biosciences Inc. (EVFM) are up 22 percent year-to-date while the iShares Nasdaq Biotechnology ETF (IBB), a bellwether of investor sentiment, has gained only 2.5 percent for the same period.

Evofem Biosciences is a clinical-stage biopharmaceutical company developing innovative products to address unmet needs in women's sexual and reproductive health.

The Company's lead product candidate is Amphora, a Multipurpose Vaginal pH Regulator, for the prevention of pregnancy and vaginal lubrication. Amphora was refused approval by the FDA in 2016 due to matters relating to certain data from patients in Russia.

To address the concerns raised by the FDA, the Company successfully conducted its second pivotal, phase III trial of Amphora in preventing pregnancy, dubbed AMPOWER, and reported the results last December. The New Drug Application for Amphora is expected to be resubmitted to the FDA this quarter (Q4, 2019).

Amphora is a non-hormonal vaginal gel that is designed to maintain the pH of the vagina to inhibit sperm motility and to form a layer of gel over the vagina and cervix, preventing sperm from reaching an egg.

Besides contraception, Amphora is also being tested for the prevention of urogenital Chlamydia trachomatis infection, or chlamydia, in women, and for the prevention of urogenital Neisseria gonorrhoeae infection, or gonorrhea, in women.

A phase IIb trial evaluating Amphora in the above two indications (chlamydia and gonorrhea in women), dubbed AMPREVENCE, has been completed, with top-line data expected next month (November).

The Multipurpose Vaginal pH Regulator is also being tested for the prevention of recurrent bacterial vaginosis, or BV.

BV is caused by an imbalance of a woman's vaginal bacteria, and is characterized by unpleasant odor and abnormal vaginal discharge. The current standard of care for BV involves a prolonged course of antibiotic treatment, and currently, there is no FDA approved drug for its prevention.

A phase I dose-finding study of the Multipurpose Vaginal pH Regulator for the prevention of recurrent bacterial vaginosis has been completed.

The Company ended the second quarter of 2019, with unrestricted cash of $50.7 million.

Given the fact that a couple of events are expected this quarter, it may be worth keeping an eye on Evofem.

Privately-held Evofem completed a reverse merger with Neothetics Inc. on January 17, 2018, and the stock of the combined company "Evofem Biosciences Inc" began trading on the Nasdaq Capital Market under the ticker symbol "EVFM".

EVFM has traded in a range of $3.16 to $7.24 in the last 1 year. The stock closed yesterday's (Oct.3, 2019) trading at $5.13, up 1.18%.

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