TIDMMTFB
RNS Number : 3299C
Motif Bio PLC
19 January 2018
A shelf registration statement has been filed with the SEC, but
has not yet become effective. Any offers, solicitations of offers
to buy, or sales of these securities will only be made once the
shelf registration statement has been declared effective by the
SEC, including any prospectuses and prospectus supplements. These
securities may not be sold, nor may offers to buy be accepted,
prior to the time that the shelf registration statement becomes
effective.
This press release shall not constitute an offer to sell or a
solicitation of an offer to buy, nor shall there be any sale of
these securities in any jurisdiction in which an offer,
solicitation or sale would be unlawful prior to registration and
qualification under the securities law of such jurisdiction.
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Announces Filing of U.S. Shelf Registration
Motif Bio(R) plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced that the Company has filed a
"universal" shelf registration statement on Form F-3 with the U.S.
Securities and Exchange Commission (the "SEC"). The filing of a
shelf registration statement, a common practice by NASDAQ-listed
companies, is intended to provide the Company with more timely and
efficient access to the U.S. capital markets.
Once declared effective by the SEC, the shelf registration,
which can remain effective for up to three years, will enable the
Company to offer, issue and sell, in one or more offerings at any
time (as long as the shelf registration statement remains
effective), up to an aggregate of $80 million of ordinary shares,
including American Depositary Shares ("ADSs", where each ADS
represents 20 ordinary shares), preference shares, warrants,
subscription rights, debt securities and a combination of such
securities, separately or as units. The Company currently has no
specific plans to issue securities under this shelf registration.
The specifics of any future offering, including the prices and
terms of any securities offered by the Company, would be determined
at the time of any such offering and would be described in detail
in a prospectus supplement filed in connection with such
offering.
A copy of the base prospectus included in the shelf registration
statement may be obtained on the SEC's website at www.sec.gov. The
filing of the shelf registration statement does not affect the
statutory pre-emption rights of shareholders in the Company.
For further information please contact:
Motif Bio plc info@motifbio.com
Graham Lumsden (Chief Executive
Officer)
Robert Dickey IV (Chief Financial
Officer)
+ 44 (0)20 7418
Peel Hunt LLP (NOMAD & BROKER) 8900
Dr Christopher Golden
Oliver Jackson
Northland Capital Partners +44 (0)203 861
Limited (BROKER) 6625
David Hignell/John Howes/Rob
Rees
Walbrook PR Ltd. (UK +44 (0) 20 7933 8780 /
FINANCIAL PR & IR) motifbio@walbrookpr.com
Paul McManus/Helen Cresswell/Lianne
Cawthorne
MC Services AG (EUROPEAN IR) +49 (0)89 210 2280
Raimund Gabriel raimund.gabriel@mc-services.eu
The Trout Group (US IR) +1 (646 )378-2963
Meggie Purcell mpurcell@troutgroup.com
+1 (858) 717-2310
Russo Partners (US PR) +1 (212)845-4272
David Schull david.schull@russopartnersllc.com
Travis Kruse, Ph.D. travis.kruse@russopartnersllc.com
Note to Editors
About Motif Bio
Motif Bio plc (AIM/NASDAQ: MTFB) is a clinical-stage
biopharmaceutical company engaged in the research and development
of novel antibiotics designed to be effective against serious and
life-threatening infections in hospitalised patients caused by
multi-drug resistant bacteria, including MRSA. The Company's lead
product candidate, iclaprim, is being developed for high-risk MRSA
patient populations. The first proposed indication, and near-term
commercial opportunity, is for the treatment of ABSSSI, one of the
most common bacterial infections, with 3.6 million patients
hospitalised annually in the U.S. The Company believes that
iclaprim may be suitable for first-line empiric therapy in ABSSSI
patients, especially those with renal impairment, with or without
diabetes. Unlike current standard of care antibiotics, in clinical
trials to date, nephrotoxicity has not been observed with iclaprim
and dosage adjustment has not been required in patients with renal
impairment.
Iclaprim has an underutilised mechanism of action compared to
other antibiotics. Clinical and microbiology data indicate iclaprim
has a targeted Gram-positive spectrum of activity, low propensity
for resistance development, fixed dose administration and
favourable tolerability profile. Additionally, data support that
the inactive metabolites of iclaprim clear through the kidneys. The
Company also plans to develop iclaprim for hospital acquired
bacterial pneumonia (HABP), including ventilator associated
bacterial pneumonia (VABP), as there is a high unmet need for new
therapies in this indication. A Phase 2 trial was conducted to
study iclaprim in patients with HABP. Iclaprim has been studied in
an animal model of pulmonary MRSA infection which mimics the
pathophysiology observed in patients with cystic fibrosis. Iclaprim
has been granted orphan drug designation by the U.S. FDA for the
treatment of Staphylococcus aureus lung infections in patients with
cystic fibrosis.
Iclaprim has received Qualified Infectious Disease Product
(QIDP) designation from the FDA together with Fast Track status.
Upon acceptance by the FDA of a New Drug Application (NDA),
iclaprim will receive Priority Review status and, if approved as a
New Chemical Entity, will be eligible for 10 years of market
exclusivity in the US from the date of first approval, under the
Generating Antibiotic Incentives Now Act (the GAIN Act). In Europe,
10 years of data exclusivity is anticipated.
Forward-Looking Statements
This press release contains forward-looking statements. Words
such as "expect," "believe," "intend," "plan," "continue," "may,"
"will," "anticipate," and similar expressions are intended to
identify forward-looking statements. Forward-looking statements
involve known and unknown risks, uncertainties and other important
factors that may cause Motif Bio's actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. Motif Bio believes that these factors
include, but are not limited to, (i) the timing, progress and the
results of clinical trials for Motif Bio's product candidates, (ii)
the timing, scope or likelihood of regulatory filings and approvals
for Motif Bio's product candidates, (iii) Motif Bio's ability to
successfully commercialise its product candidates, (iv) Motif Bio's
ability to effectively market any product candidates that receive
regulatory approval, (v) Motif Bio's commercialisation, marketing
and manufacturing capabilities and strategy, (vi) Motif Bio's
expectation regarding the safety and efficacy of its product
candidates, (vii) the potential clinical utility and benefits of
Motif Bio's product candidates, (viii) Motif Bio's ability to
advance its product candidates through various stages of
development, especially through pivotal safety and efficacy trials,
(ix) Motif Bio's estimates regarding the potential market
opportunity for its product candidates, and (x) the factors
discussed in the section entitled "Risk Factors" in Motif Bio's
Annual Report on Form 20-F filed with the SEC on May 1, 2017, which
is available on the SEC's web site, www.sec.gov. Motif Bio
undertakes no obligation to update or revise any forward-looking
statements.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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January 19, 2018 02:00 ET (07:00 GMT)
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