SAN DIEGO, Sept. 18, 2018 /PRNewswire/ -- Evofem Biosciences, Inc., (NASDAQ: EVFM) ("Evofem" or the "Company"), a clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health, announced today that the Company will present at the Cantor Fitzgerald 20th Annual Global Investment Conference as follows:
Wednesday, October 3, 2018
10:20 a.m. EDT
InterContinental New York Barclay Hotel, New York City
Additionally, the Company will participate in the Oppenheimer Fall Summit in New York City on Wednesday September 26, 2018. This event is focused on Specialty Pharma & Rare Disease companies, and will consist entirely of 1x1 and small group meetings.
Top-line data are expected by year-end 2018 from the second Phase 3 clinical trial of Amphora® (L-lactic acid, citric acid, and potassium bitartrate) for prevention of pregnancy. This Multipurpose Vaginal pH Regulator (MVP-R) candidate is expected to be Evofem's first commercial product. Assuming positive results, the Company plans to re-submit the Amphora New Drug Application (NDA) in the second quarter of 2019. If approved by the FDA, Evofem will commercialize Amphora in early 2020 as the first and only hormone-free, on-demand, woman-controlled birth control drug.
A Phase 2b double-blinded placebo-controlled efficacy trial (AMPREVENCE) is underway to evaluate of Amphora for the prevention of urogenital acquisition of Chlamydia trachomatis (primary endpoint) and Neisseria gonorrhea (secondary endpoint) in women. This clinical trial is actively enrolling up to 844 women at approximately 50 centers in the United States for a four-month interventional period and subsequent one-month follow-up period.
Earlier this year, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Amphora for the prevention of urogenital chlamydia in women. Fast Track designation is designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs. There are currently no FDA-approved products for the prevention of chlamydia in women.
The CDC recently reported that rates of syphilis, gonorrhea and chlamydia have climbed for the fourth consecutive year in the United States. Last year, nearly 2.3 million U.S. cases of these STDs were diagnosed, according to preliminary data, an increase of over 200,000 cases as compared with 2016.1
Institutional investors who would like to schedule a one-on-one meeting with Evofem's management team but who are not attending the Oppenheimer or Cantor conferences should contact Amy Raskopf at email@example.com.
Amphora® is an investigational non-hormonal gel designed to regulate vaginal pH to within the normal range of 3.5 to 4.5 even in the presence of semen. 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 is being evaluated in a single-arm, open-label Phase 3 clinical trial (AMP002) for the prevention of pregnancy and a double-blinded placebo-controlled Phase 2b clinical trial (AMPREVENCE) for prevention of urogenital acquisition of Chlamydia trachomatis (primary endpoint) and Neisseria gonorrhea (secondary endpoint) in women.
About Evofem Biosciences
Evofem Biosciences, Inc. (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 pipeline includes two proprietary Multipurpose Vaginal pH Regulator (MVP-R) product candidates. The Company expects to report top-line Phase 3 data on its lead MVP-R drug candidate, Amphora®, for prevention of pregnancy by year-end 2018. For more information regarding Evofem, please visit www.evofem.com.
Statements in this press release about Evofem's future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the Company's control. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in the Company's filings with the Securities and Exchange Commission (SEC), including its Quarterly Report for the period ended March 31, 2018, as filed with the SEC on Form 10-Q on May 14, 2018, and include but are not limited to the following: objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the Company intends, expects, projects, believes or anticipates will or may occur in the future; risks and uncertainties associated with market conditions; statements about the anticipated results of the Phase 3 clinical trial evaluating Amphora as a contraceptive and the Phase 2b clinical trial of Amphora to prevent urogenital acquisition of Chlamydia trachomatis and Neisseria gonorrhea in women, and any expected completion dates or general timing for these clinical trials; the Company's reliance on third parties to conduct its clinical trials, research and development and manufacturing; the availability of reimbursement from government authorities and health insurance companies for the Company's products; the impact of potential product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the Company's common stock, and the concentration of power in its stock ownership. Forward-looking statements in this press release are made as of the date of this press release, and the Company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Evofem's views as of any date subsequent to the date hereof. We have included certain information from government publications which was obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. We have not independently verified market and industry data from any third-party sources.
1Centers for Disease Control and Prevention (2018): STD Preliminary Data Accessed August 2018.
Amphora® is a registered trademark of Evofem Biosciences, Inc.
Evofem Biosciences, Inc.
O: 858-550-1900 x167
O: (646) 599-8630
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SOURCE Evofem Biosciences, Inc.