Neothetics, Inc. (NASDAQ:NEOT) and Evofem Biosciences, Inc. today
announced they have entered into a definitive agreement under which
privately-held Evofem Biosciences will merge with a wholly-owned
subsidiary of Neothetics in an all-stock transaction. The merger
will position the combined company with an opportunity to become a
leading women’s health company that develops and commercializes
novel products. Upon closing of the transaction, Neothetics will be
renamed Evofem Biosciences, Inc., and will be under the leadership
of Evofem Biosciences’ Chief Executive Officer, Saundra Pelletier.
An affiliate of an existing Evofem Biosciences’
investor, Invesco Asset Management Ltd., has entered into a
securities purchase agreement to acquire an additional $20 million
of common stock in the combined company immediately following the
completion of the merger.
“Following an extensive and thorough review of
strategic alternatives, we believe the proposed merger with Evofem
Biosciences provides the best opportunity to maximize value for
Neothetics’ shareholders,” said Martha Demski, a member of
Neothetics Strategic Transaction Committee and Board of
Directors. “We believe the strength of the leadership team,
coupled with the completion of its pregnancy prevention trial, will
enable Amphora® to reach significant value inflection points in the
near term.”
“This merger and concurrent financing provides
continued funding for Evofem Biosciences’ ongoing Phase III study
of Amphora® as a vaginal contraceptive – AMPOWER. We expect
to close the study database and file for FDA review in the second
quarter of 2019,” said Saundra Pelletier, Chief Executive Officer
of Evofem Biosciences. “In addition, we have expanded our
Amphora® clinical development platform with potential supplemental
indications which would further strengthen its position as a
cornerstone therapy in hormone-free birth control and as a
preventative option for certain sexually transmitted
infections.”
Amphora® is an on-demand non-hormonal, woman
controlled, surfactant-free investigational new drug being
developed as a vaginal contraceptive and for the prevention of
certain sexually transmitted infections. Amphora® is also
designated as a Qualified Infectious Disease Product (QIDP) by the
U.S. Food & Drug Administration for two separate indications:
the prevention of urogenital gonorrhea infection in women, and for
the reduction of reoccurrence of bacterial vaginosis. These two
QIDP designations could potentially offer a significant advancement
in Evofem Biosciences’ efforts to make this drug available to women
at risk of infection.
The AMPOWER trial is a single-arm, Phase III,
open-label, multicenter, study in women aged 18-35 years of the
contraceptive efficacy and safety of Amphora® contraceptive vaginal
gel. The trial is expected to enroll approximately 1,350
women at risk of pregnancy at over 100 centers in the United
States. The primary endpoint is the contraceptive efficacy of
Amphora® over seven cycles of use.
“Evofem Biosciences is positioned to become a
leading provider of women’s healthcare solutions with a much needed
and truly differentiated offering,” said Mr. Thomas Lynch, Evofem
Biosciences’ Chairman. “This merger with Neothetics creates an even
stronger platform for the advancement of Evofem initiatives which
will continue to create value for shareholders.”
Details of the Proposed Transaction
The parties determined the exchange ratio in the
merger agreement by assuming $171,400,000 in value of Neothetics
common stock will be issued to the Evofem Biosciences stockholders
in the merger with $28,600,000 in value of common stock being
retained by the Neothetics stockholders, in each case immediately
prior to the Invesco financing. On a pro forma basis after
giving effect to both the number of shares of Neothetics common
stock issued in the merger and the number of shares of Neothetics
common stock issued to Invesco in the Invesco financing, current
Neothetics stockholders will own approximately 13% of the combined
company and current Evofem Biosciences stockholders, including
Invesco, will own approximately 87% of the combined company. The
transactions have been approved by the board of directors of both
companies. The merger is expected to close in January 2018, subject
to the approval of the stockholders of each company as well as
other customary conditions.
Neothetics financial advisor in the transaction
is Oppenheimer & Co, Inc. RBC Capital Markets is serving
as financial advisor to Evofem Biosciences. DLA Piper LLP
(US) is serving as legal counsel to Neothetics and Mintz, Levin,
Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel
to Evofem Biosciences.
Management and
Organization
Following the merger, the company will be led by
Saundra Pelletier as Chief Executive Officer. The board of
directors of the combined company is anticipated to be comprised of
seven representatives, one of whom will be designated by Neothetics
and the remaining six of whom will be designated by Evofem
Biosciences, including, Ms. Pelletier and Mr. Lynch, Evofem
Biosciences’ Chairman.
About Neothetics, Inc.
Neothetics is a San Diego based
clinical-stage specialty pharmaceutical company that has been
focused on developing therapeutics for the aesthetic market. For
more information on Neothetics, please
visit www.neothetics.com. Neothetics, LIPO-202, LIPO-102
and the Neothetics logo are trademarks or registered
trademarks of Neothetics. For more information on Neothetics,
please visit www.neothetics.com
About Evofem Biosciences, Inc.
Evofem Biosciences develops and anticipates
commercializing innovative products that support and promote women
as the primary healthcare consumer. Evofem Biosciences is currently
identifying and developing new and novel products that specifically
address unmet needs in the areas of sexual and reproductive health,
the prevention of acquisition of sexually transmitted infections
and products that address or promote general health and wellbeing.
For more information on Evofem Biosciences, please visit
www.evofem.com.
Additional Information about the Proposed Merger and
Where to Find It
In connection with the proposed merger,
Neothetics intends to file relevant materials with the Securities
and Exchange Commission, or the SEC, including a registration
statement on Form S‑4 that will contain a prospectus and a proxy
statement/information statement. Investors and security
holders of Neothetics and Evofem Biosciences are urged to read
these materials when they become available because they will
contain important information about Neothetics, Evofem Biosciences
and the proposed merger. The proxy statement/information statement,
prospectus and other relevant materials (when they become
available), and any other documents filed by Neothetics with the
SEC, may be obtained free of charge at the SEC web site at
www.sec.gov. In addition, investors and security holders may obtain
free copies of the documents filed with the SEC by Neothetics by
directing a written request to: Neothetics Inc., 9171 Towne Centre
Drive, Ste. 250, San Diego, CA 92122, Attn: Investor Relations.
Investors and security holders are urged to read the joint proxy
statement, prospectus and the other relevant materials when they
become available before making any voting or investment decision
with respect to the proposed merger.
This communication shall not constitute an offer
to sell or the solicitation of an offer to sell or the solicitation
of an offer to buy any securities, nor shall there be any sale of
securities in any jurisdiction in which such offer, solicitation or
sale would be unlawful prior to registration or qualification under
the securities laws of any such jurisdiction. No offering of
securities in connection with the proposed merger shall be made
except by means of a prospectus meeting the requirements of
Section 10 of the Securities Act of 1933, as amended.
Participants in the Solicitation
Neothetics and its directors and executive
officers and Evofem Biosciences and its directors and executive
officers may be deemed to be participants in the solicitation of
proxies from the stockholders of Neothetics and Evofem Biosciences
in connection with the proposed transaction. Information regarding
the special interests of these directors and executive officers in
the proposed merger will be included in the proxy
statement/information statement/prospectus referred to above.
Additional information regarding the directors and executive
officers of Neothetics is also included in Neothetics Annual Report
on Form 10-K for the year ended December 31, 2016 and the proxy
statement for Neothetics 2017 Annual Meeting of Stockholders. These
documents are available free of charge at the SEC web site
(www.sec.gov) and from Investor Relations at Neothetics at the
address described above.
Cautionary Note Regarding Forward-Looking
Statements
Certain statements in this communication
regarding the proposed merger and other contemplated transactions
(including statements relating to satisfaction of the conditions to
and consummation of the proposed merger, the expected ownership of
the combined company, the alternatives to the proposed merger, and
the ability of the combined company to raise additional capital to
complete its clinical programs) constitute "forward-looking
statements" within the meaning of Section 27A of the Securities Act
and Section 21E of the Securities Exchange Act and are usually
identified by the use of words such as "anticipates," "believes,"
"estimates," "expects," "intends," "may," "plans," "projects,"
"seeks," "should," "will," and variations of such words or similar
expressions. We intend these forward-looking statements to be
covered by the safe harbor provisions for forward-looking
statements contained in Section 27A of the Securities Act and
Section 21E of the Securities Exchange Act and are making this
statement for purposes of complying with those safe harbor
provisions. These forward-looking statements reflect our current
views about our plans, intentions, expectations, strategies and
prospects, which are based on the information currently available
to us and on assumptions we have made. Although we believe that our
plans, intentions, expectations, strategies and prospects as
reflected in or suggested by those forward-looking statements are
reasonable, we can give no assurance that the plans, intentions,
expectations or strategies will be attained or achieved.
Furthermore, actual results may differ materially from those
described in the forward-looking statements and will be affected by
a variety of risks and factors that are beyond our control.
Risks and uncertainties for Neothetics and
Evofem Biosciences and of the combined company include, but are not
limited to: inability to complete the proposed merger and other
contemplated transactions in connection with the merger; liquidity
and trading market for shares prior to and following the
consummation of the proposed merger and proposed financing; costs
and potential litigation associated with the proposed merger; the
inability to raise the additional capital necessary to complete
current and anticipated clinical trials; failure or delay in
obtaining required approvals by the SEC or any other governmental
or quasi-governmental entity necessary to consummate the proposed
merger, including our ability to file an effective proxy
statement/information statement/prospectus in connection with the
proposed merger and other contemplated transactions in connection
with the merger, which may also result in unexpected additional
transaction expenses and operating cash expenditures on the
parties; an inability or delay in obtaining required regulatory
approvals for product candidates, which may result in unexpected
cost expenditures; risks inherent in drug development in general;
uncertainties in obtaining successful clinical results for product
candidates and unexpected costs that may result therefrom; failure
to realize any value of certain product candidates developed and
being developed in light of inherent risks and difficulties
involved in successfully bringing product candidates to market;
inability to develop new product candidates and support existing
products; the approval by the FDA and EMA and any other similar
foreign regulatory authorities of other competing or superior
products brought to market; risks resulting from unforeseen side
effects; risk that the market for the combined company's products
may not be as large as expected; inability to obtain, maintain and
enforce patents and other intellectual property rights or the
unexpected costs associated with such enforcement or litigation;
inability to obtain and maintain commercial manufacturing
arrangements with third party manufacturers or establish commercial
scale manufacturing capabilities; loss of or diminished demand from
one or more key customers or distributors; unexpected cost
increases and pricing pressures; failure to obtain the necessary
stockholder approvals or to satisfy other conditions to the closing
of the proposed merger and the other contemplated transactions; a
superior proposal being submitted to either party; uncertainties of
cash flows and inability to meet working capital needs; and risks
associated with the possible failure to realize certain benefits of
the proposed merger, including future financial, tax, accounting
treatment, and operating results. Many of these factors that will
determine actual results are beyond Neothetics, Evofem Biosciences,
or the combined company's ability to control or predict.
Other risks and uncertainties are more fully
described in periodic filings with the Securities and Exchange
Commission (the "SEC"), including the risk factor disclosure
set forth in the reports and other documents the company files with
the SEC available at www.sec.gov, including without
limitation, Neothetics’ Form 10-K for the year ended December
31, 2016 and subsequent Quarterly Reports on Form 10-Q and in
other filings that Neothetics makes and will make with the SEC in
connection with the proposed transactions, including the proxy
statement described above "Important Information and Where to Find
It." Existing and prospective investors are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date hereof. The statements made in this press
release speak only as of the date stated herein, and subsequent
events and developments may cause our expectations and beliefs to
change. Unless otherwise required by applicable securities laws, we
do not intend, nor do we undertake any obligation, to update or
revise any forward-looking statements contained in this news
release to reflect subsequent information, events, results or
circumstances or otherwise. While we may elect to update these
forward-looking statements publicly at some point in the future, we
specifically disclaim any obligation to do so, whether as a result
of new information, future events or otherwise, except as required
by law.
Neothetics Contact: Susan A.
Knudson Chief Financial Officer (858) 500-7780
sknudson@neothetics.com or ir@neothetics.com
Evofem Biosciences’ Contact: Ellen Thomas VP,
Global Governance and Communications (718) 490-3248
ethomas@evofem.com
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