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:
Date:
|
Wednesday, October 3,
2018
|
Time:
|
10:20 a.m.
EDT
|
Location:
|
InterContinental New
York Barclay Hotel, New York City
|
Webcast
(live and archive):
|
www.evofem.com in the "Investors" section under
"Events and Presentations"
|
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 ir@evofem.com.
About Amphora
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.
Forward-Looking Statements
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.
Investor Contact
Amy
Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
O: 858-550-1900 x167
Media Contact
Sophia
Ononye
RXMD
evofem@rxmedyn.com
O: (646) 599-8630
M: (917) 557-1909
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SOURCE Evofem Biosciences, Inc.