SAN DIEGO, April 28, 2020 /PRNewswire/ -- Evofem
Biosciences, Inc. (NASDAQ: EVFM), a clinical-stage
biopharmaceutical company, today announced that it will host a
webcast and conference call to discuss the Company's financial
results for the first quarter ended March 31, 2020, and
provide a general business overview, on Wednesday, May 6, 2020 at 11:00 a.m. ET (8:00 a.m.
PT).
Key Highlights:
Regulatory
Milestones
- The Company has entered into discussions with the U.S. Food and
Drug Administration (FDA) regarding the proposed label for
Phexxi™ (L-lactic acid, citric acid, potassium bitartrate)
Vaginal Gel 1.8%/1%/0.4%, the Company's first-in-class
investigational Multipurpose Vaginal pH Regulator (MVP-R™) for the
prevention of pregnancy. While there can be no assurance
that the FDA will approve Phexxi, or that such approval
will occur by the PDUFA target action date of May 25, 2020, the Company is encouraged by the
ongoing interactions with the agency.
- The FDA has scheduled an end-of-Phase 2 meeting on Wednesday, May 6, 2020 to review results of the
AMPREVENCE trial and determine the clinical and regulatory path
forward for EVO100, the Company's MVP-R candidate for the
prevention of urogenital chlamydia and gonorrhea in women.
Update on Financing and Commercial Launch Plans
- The Company recently secured up to $25
million in strategic interim financing to support its launch
and commercialization plans for Phexxi.
- Simultaneously, the Company has taken a proactive approach to
reducing its near-term cash burn to ensure maximum flexibility for
launch execution.
- The Company will provide an update on the impact of COVID-19 on
its business operations and launch plans.
Conference Call Details
The live webcast and
presentation can be accessed on the Company's Investor page
at https://evofem.investorroom.com/events. Please connect to
the Company's website at least 15 minutes prior to the start of the
call to download any software that may be required. If
participating by phone, please dial in approximately 10 minutes
prior to the start of the call.
Date
|
Wednesday, May 6,
2020
|
Time
|
11:00 a.m. EDT (8:00
a.m. PDT)
|
Dial-in
numbers
|
(866) 503-5561 (U.S.
toll-free) or (253) 336-2965
|
Passcode
|
6295478
|
Webcast (live and
archived)
|
www.evofem.com under "Investors" or click
here
|
A telephone replay will be available approximately two hours
after the call through Monday, May 11, 2020 at (855)
859-2056 (U.S.) or (404) 537-3406 (International), access code
6295478. The webcast will be archived
at https://evofem.investorroom.com/events.
About Phexxi™
Phexxi (L-lactic acid, citric acid,
potassium bitartrate) Vaginal Gel 1.8%/1%/0.4% is an
investigational Multipurpose Vaginal pH Regulator (MVP-R™) designed
to regulate vaginal pH within the normal range of 3.5 to 4.5, even
in the presence of semen, which normally raises the vaginal pH to
7.0 to 8.0. This maintains an acidic environment that 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.
About Evofem Biosciences,
Inc.
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 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's lead
product candidate, Phexxi™, is currently being reviewed by the U.S.
Food and Drug Administration for prevention of pregnancy. The
investigational candidate EVO100 is being evaluated for prevention
of urogenital transmission of both Chlamydia
trachomatis infection (chlamydia) and Neisseria
gonorrhoeae infection (gonorrhea) in women. For more
information regarding Evofem, please visit www.evofem.com.
Phexxi™ and Multipurpose Vaginal pH Regulator (MVP-R™) are
trademarks of Evofem Biosciences, Inc.
Forward-Looking Statements
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, without limitation, statements related to the potential
FDA approval of Phexxi™, the anticipated commercial launch of
Phexxi, the timing and potential outcome of the scheduled meeting
with the FDA to discuss the AMPREVENCE trial results and the
clinical path for EVO100 for the prevention of urogenital
acquisition of Chlamydia
trachomatis and Neisseria gonorrhea in
women. Actual results may differ materially from those,
express or implied, in these forward-looking statements. Each
of these forward-looking statements involves risks and
uncertainties, including, without limitation, risks relating to the
Company's business, operations and financial condition as well as
risks relating to general industry, economic, political and market
conditions, including the impact of the novel coronavirus
(COVID-19) and the duration and severity of outbreaks
thereof. Additional important factors that could affect the
Company's business, operations and/or financial condition 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.
Contact
Investor Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
M: (917) 673-5775
Media Contact
Cara Miller
Evofem Biosciences, Inc.
cmiller@evofem.com
O: (858) 550-1900 x272
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SOURCE Evofem Biosciences, Inc.