SAN DIEGO, Oct. 15, 2020 /PRNewswire/ -- Evofem Biosciences,
Inc., (NASDAQ: EVFM) announced today that it has sold $25 million of unsecured convertible promissory
notes to funds affiliated with Adjuvant Capital, LP ("Adjuvant
Capital"). The notes are convertible into shares of Evofem common
stock at a conversion price of $3.65
per share. Proceeds from the sale of the notes will be used to
support EVOGUARD, Evofem's planned Phase 3 clinical trial of EVO100
for the prevention of urogenital chlamydia and gonorrhea in women,
and to expand global market access for Phexxi™ (lactic acid, citric
acid, potassium bitartrate) vaginal contraceptive gel.
"Adjuvant's goal is to accelerate the availability of the most
impactful healthcare technologies through strategic investments in
innovative companies with strong management teams. Our cornerstone
women's health investment in Evofem is strongly aligned with our
vision to expand access to contraceptives globally," said
Jenny Yip, Managing Partner at
Adjuvant Capital. "We are excited to forge this unique alliance
with Evofem Biosciences, an emerging leader in women's health that
is developing and commercializing products with potential to
address pressing unmet global health needs."
"Our success will be measured by our ability to execute," said
Saundra Pelletier, Evofem's Chief
Executive Officer. "This is strengthened through committed
partnerships with investors like Adjuvant who understand that
Evofem Biosciences, Phexxi, and our mission to deliver innovation
to women are unique, necessary, and have the potential to transform
women's health in the United
States and around the world."
Phexxi, a non-hormonal vaginal contraceptive gel, was approved
in May 2020 by the U.S. Food and
Drug Administration (FDA). The Company launched Phexxi in
the United States on September 8, 2020, and intends to commercialize
Phexxi outside the United States
(subject to the requisite regulatory approvals) with global
biopharmaceutical partners.
Evofem is on track to initiate the pivotal Phase 3 clinical
trial EVOGUARD in the fourth quarter of 2020 to evaluate the safety
and efficacy of EVO100 for the prevention of
urogenital Chlamydia
trachomatis and Neisseria gonorrhea in women.
EVOGUARD builds on the positive and statistically significant
outcomes of AMPREVENCE, Evofem's double-blinded, placebo-controlled
Phase 2b clinical trial of EVO100 completed in 2019.
Rates of infection for Chlamydia trachomatis and
Neisseria gonorrhea climbed in 2018 for the fifth
consecutive year in the United
States.1 Globally, an estimated 95 million women
are likely to contract chlamydia or gonorrhea by 2025.2
Gonorrhea is increasingly becoming antibiotic resistant, making it
much harder, or sometimes impossible, to treat.3 There
are no FDA-approved prescription products for the prevention of
either of these dangerous infections.
EVO100 has been granted Fast Track Designation for the
prevention of chlamydia in women by the FDA, and is an
FDA-designated Qualified Infectious Disease Product (QIDP) for the
prevention of gonorrhea in women.
About Adjuvant Capital
Adjuvant is a New York-
and San Francisco-based life sciences investor built to
accelerate the development of new technologies for the world's most
pressing public health challenges. Backed by prominent healthcare
investors such as Novartis, Merck, the International Finance
Corporation, and the Bill & Melinda Gates Foundation, Adjuvant
draws upon its global network of scientists, public health experts,
biopharmaceutical industry veterans, and development finance
professionals to identify new investment opportunities. Adjuvant
invests in companies developing promising new vaccines,
therapeutics, diagnostics and medical devices for historically
overlooked indications such as malaria, cholera, Lassa fever, and
postpartum hemorrhage, with a commitment to make these
interventions accessible to those who need them most in low- and
middle-income countries. For more information,
visit www.adjuvantcapital.com.
About Evofem Biosciences
Evofem Biosciences, Inc.,
(NASDAQ: EVFM) is a commercial-stage biopharmaceutical company
committed to developing and commercializing innovative products to
address unmet needs in women's sexual and reproductive health,
including hormone-free, woman-controlled contraception and
protection from certain sexually transmitted infections (STIs). The
Company's first commercial product, Phexxi™ (lactic acid, citric
acid and potassium bitartrate), is the first and only hormone-free,
prescription vaginal gel approved in the United
States for the prevention of pregnancy. The Company is also
advancing EVO100 into a Phase 3 clinical trial for the prevention
of urogenital transmission of both Chlamydia
trachomatis and Neisseria gonorrhoeae in
women. For more information, please
visit www.evofem.com.
Phexxi™ is a trademark of Evofem Biosciences, Inc.
Forward-Looking Statements
This press release
includes "forward-looking statements," within the meaning of the
safe harbor for forward-looking statements provided by Section 21E
of the Securities Exchange Act of 1934, as amended; and the Private
Securities Litigation Reform Act of 1995, including, without
limitation, statements related to the potential commercial success
and impact of Phexxi and EVO100, Evofem's plans to commercialize
Phexxi or to commercialize and develop any of its product
candidates and Evofem's ability to progress EVO100 through clinical
development and the timing of these activities.. Various factors
could cause actual results to differ materially from those
discussed or implied in the forward-looking statements, and you are
cautioned not to place undue reliance on these forward-looking
statements, which are current only as of the date of this press
release. Each of these forward-looking statements involves risks
and uncertainties. Important factors that could cause actual
results to differ materially from those discussed or implied in the
forward-looking statements, or that could impair the value of
Evofem Biosciences' assets and business, are disclosed in Evofem's
SEC filings, including its Annual Report on Form 10-K for the year
ended December 31, 2019 filed with the SEC on March
12, 2020, its Quarterly Report on Form 10-Q for the quarter
ended March 31 filed with the SEC on May 6,
2020 and August 4, 2020, and its Current Report on Form
8-K filed with the SEC on June 2, 2020. All forward-looking
statements are expressly qualified in their entirety by such
factors. Evofem does not undertake any duty to update any
forward-looking statement except as required by law. The
information contained in this release from third party sources has
been obtained from sources Evofem believes to be reliable, but the
accuracy and completeness of this information is not guaranteed.
Evofem has not independently verified any of the data from
third-party sources.
References
1 Centers for Disease
Control and Prevention (2019): 2018
STD Surveillance Report.
2 Chlamydia, gonorrhea, trichomonas and syphilis:
global prevalence and incidence estimates. June 6, 2019.
3 Centers for Disease Control and Prevention
(2018): Antibiotic-Resistant Gonorrhea Basic Information.
Investor Relations Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Office: (858) 550-1900 x167
Mobile: (917) 673-5775
Media Contact
Ellen
Thomas
Evofem Biosciences, Inc.
ethomas@evofem.com
Mobile: (718) 490.3248
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SOURCE Evofem Biosciences, Inc.