TIDMMTFB
RNS Number : 9556T
Motif Bio PLC
26 March 2019
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the Market Abuse Regulation (EU) No. 596/2014. Upon the publication
of this announcement via the Regulatory Information Service, this
inside information is now considered to be in the public
domain.
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR
INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES,
AUSTRALIA, CANADA, JAPAN OR THE REPUBLIC OF SOUTH AFRICA OR ANY
OTHER JURISDICTION IN WHICH THE SAME WOULD BE UNLAWFUL.
THIS ANNOUNCEMENT DOES NOT CONSTITUTE AN OFFERING OF ANY
SECURITIES. ANY OFFERING OF SECURITIES BY THE COMPANY IS NOT
ADDRESSED TO ANY PERSON WITH A REGISTERED ADDRESS IN, OR WHO IS
RESIDENT IN, THE UNITED STATES OR ANY U.S. PERSON, AND NO SUCH
PERSONS ARE ENTITLED TO PARTICIPATE IN ANY SUCH OFFERING.
This announcement does not constitute an offer to buy, acquire
or subscribe for (or the solicitation of an offer to buy, acquire
or subscribe for) ordinary shares 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.
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Raises GBP2.7m (US$3.55m)
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, announces it has raised GBP2.7 million (US$3.55
million), before expenses by way of a placing (the "Placing") via
the issue of 45,000,000 ordinary shares in the capital of the
Company with new and existing investors (the "Placing Shares") at
an issue price of 6p per Placing Share, to provide Motif with
additional working capital.
As announced by the Company on 20 March 2019, a Type A meeting
with the U.S. Food and Drug Administration ("FDA") has been
scheduled for 3 May 2019 to discuss the points raised in the
Complete Response Letter received in respect of the Company's New
Drug Application (NDA) for iclaprim for the treatment of acute
bacterial skin and skin structure infections. The Company expects
to be able to provide guidance regarding the path forward for
iclaprim upon receipt of the minutes from this meeting, which would
typically be within 30 days from the meeting date.
The net proceeds from the Placing, when taken together with the
Company's existing cash resources, are expected to be sufficient to
fund the business beyond the expected receipt of the FDA meeting
minutes in June.
Assuming a viable route to approval, it is expected that further
additional funds will be required to resubmit an NDA and reach a
new approval date.
Graham Lumsden, Chief Executive Officer of Motif Bio, said:
"We are encouraged by the support shown by both new and existing
investors as we strengthen our balance sheet. The Company now
expects to be funded through completion of the FDA meeting and
receipt of the minutes, which should provide guidance regarding the
path forward for iclaprim."
Details of the Placing
The Placing Shares will rank pari passu with the existing
ordinary shares of 1 pence each in the capital of the Company (the
"Ordinary Shares") and application has been made for the Placing
Shares to be admitted to trading on AIM ("Admission"). The Placing
is conditional, inter alia, on Admission, and dealings are expected
to commence at 8.00am on 29 March 2019.
The Placing, which utilises the Company's existing authorities
to issue Ordinary Shares, was undertaken by SP Angel Corporate
Finance LLP ("SP Angel") who acted as bookrunner to the Company. SP
Angel has also been appointed as the Company's Joint Broker with
immediate effect.
Total Voting Rights
Following Admission, the Company's enlarged issued share capital
will comprise 342,491,023 Ordinary Shares with voting rights. This
figure may therefore be used by shareholders in the Company as the
denominator for the calculations by which they will determine if
they are required to notify their interest in, or a change in their
interest in, the share capital of the Company under the FCA's
Disclosure Guidance and Transparency Rules.
The person responsible for the release of this announcement on
behalf of Motif Bio plc is Jonathan Gold, Interim Chief Financial
Officer.
A copy of this announcement has been posted on the Company's
website at www.motifbio.com.
For further information please contact:
Motif Bio plc info@motifbio.com
Graham Lumsden (Chief Executive
Officer)
Peel Hunt LLP (NOMAD & JOINT
BROKER) + 44 (0)20 7418 8900
Dr Christopher Golden
Oliver Jackson
SP ANGEL CORPORATE FINANCE LLP
(BOOKRUNNER & JOINT BROKER) +44 (0)20 3470 0470
David Hignell
Vadim Alexandre
Rob Rees
Walbrook PR Ltd. (UK FINANCIAL
PR & IR) +44 (0) 20 7933 8780
Paul McManus/Helen Cresswell/
Lianne Cawthorne
MC Services AG (EUROPEAN IR) +49 (0)89 210 2280
Raimund Gabriel raimund.gabriel@mc-services.eu
Note to Editors
Motif Bio plc (AIM/NASDAQ: MTFB) is a clinical-stage
biopharmaceutical company focused on developing novel antibiotics
designed to be effective against serious and life-threatening
infections caused by multi-drug resistant Gram-positive bacteria,
including MRSA. The Company's lead product candidate is iclaprim.
Motif Bio is seeking approval of iclaprim from the U.S. Food &
Drug Administration (FDA) for the treatment of acute bacterial skin
and skin structure infections (ABSSSI). More than 3.6 million
patients with ABSSSI are hospitalised annually in the U.S. It is
estimated that up to 26% of hospitalized ABSSSI patients have renal
impairment.
The Company also has 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 in
patients with HABP has been successfully completed and a Phase 3
trial is being planned. Additionally, iclaprim has been granted
orphan drug designation by the FDA for the treatment of
Staphylococcus aureus lung infections in patients with cystic
fibrosis and is in preclinical development for this indication.
Iclaprim has received Qualified Infectious Disease Product
(QIDP) designation from the FDA together with Fast Track status for
the ABSSSI indication. If approved for the ABSSSI indication as a
New Chemical Entity, iclaprim will be eligible for 10 years of
market exclusivity in the U.S. from the date of first approval,
under the Generating Antibiotic Incentives Now Act (the GAIN Act).
In Europe, 10 years of market exclusivity is anticipated. Motif is
also building a patent estate to provide additional protection for
iclaprim and has two U.S. method of use patents issued that will
expire in 2037.
Forward-Looking Statements
This 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, (x) Motif Bio's ability to
raise additional capital to sustain its operations and pursue its
strategy and (xi) the factors discussed in the section entitled
"Risk Factors" in Motif Bio's Annual Report on Form 20-F filed with
the SEC on April 10, 2018, 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 news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
IOEPGUBCWUPBPPA
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March 26, 2019 03:01 ET (07:01 GMT)
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