TIDMMTFB
RNS Number : 5092W
Motif Bio PLC
15 November 2017
The information contained within this announcement is deemed by
Motif Bio plc 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
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio secures up to US$20 million debt financing
London and New York, Motif Bio plc (AIM/NASDAQ: MTFB), a
clinical stage biopharmaceutical company specialising in developing
novel antibiotics, announced today that the Company has entered
into an agreement for up to US$20 million in debt financing with
Hercules Capital, Inc. (NYSE: HTGC), a leader in customised debt
financing for companies in life sciences and technology-related
markets. The funds will be used to fund pre-commercialisation
activities and other corporate activities in preparation for the
anticipated US launch of iclaprim in 2019.
The first tranche of US$15 million will be drawn down
immediately, with the remaining US$5 million available upon the
achievement of certain milestones anticipated in 2018, or at the
lender's discretion. The terms are typical for facilities of this
type and include an initial interest-only period of 15 months,
extendable to 21 months on the achievement of certain milestones; a
30-month capital and interest repayment period thereafter; an
interest rate of 10% tied to the US prime rate and customary
security over all assets of the Company, except for intellectual
property where there is a negative pledge. Under the agreement, the
Company shall issue Hercules warrants to purchase up to 73,452 of
its American Depository Shares (ADSs) (each representing 20
ordinary shares) at an exercise price of US$9.53 per ADS,
representing 3.5% of the loan. Hercules also has the right, in its
discretion, to participate in any subsequent financing, such as an
equity offering, in an amount up to US$1 million.
The Company expects to submit a New Drug Application (NDA) for
iclaprim for the treatment of acute bacterial skin and skin
structure infections (ABSSSI) to the US Food and Drug
Administration (FDA) by the end of the first quarter of 2018 and,
if accepted, a decision on approval to market is anticipated in the
fourth quarter of 2018. The Company is also progressing a Marketing
Authorisation Application in parallel and expects to make a
submission to the European Medicines Agency during the second
quarter of 2018.
Robert Dickey, IV, Chief Financial Officer of Motif Bio
commented, "The financing we have secured provides us additional
flexibility as we pursue our corporate objectives, including
submitting a NDA for iclaprim in the first quarter of 2018 and
continuing our pre-commercialisation activities."
Scott Bluestein, Chief Investment Officer at Hercules Capital
commented, "Hercules is pleased to enter into this financing
partnership with Motif Bio as the Company moves its differentiated
antibiotic through NDA filing and, hopefully, to commercialisation.
This investment provides another example of our ability to finance
life sciences companies developing drugs for unmet needs."
The person responsible for the release of this announcement on
behalf of Motif Bio plc is Robert Dickey IV, Chief Financial
Officer.
For further information, please contact:
Motif Bio plc info@motifbio.com
Graham Lumsden (Chief Executive
Officer)
Robert Dickey IV (Chief Financial
Officer)
Peel Hunt LLP (NOMAD & BROKER)
Dr Christopher Golden
Oliver Jackson + 44 (0)20 7418 8900
Northland Capital Partners Limited
(BROKER) Patrick Claridge/ David
Hignell
John Howes/ Rob Rees (Broking) +44 (0)203 861 6625
Walbrook PR Ltd. (UK FINANCIAL +44 (0) 20 7933 8780 / motifbio@walbrookpr.com
PR & IR)
Paul McManus Mob: +44 (0)7980 541 893
Mike Wort Mob: +44 (0)7900 608 002
MC Services AG (EUROPEAN IR) +49 (0)89 210 2280
Raimund Gabriel raimund.gabriel@mc-services.eu
The Trout Group (US IR) +1 (646 )378-29363
Meggie Purcell mpurcell@troutgroup.com
Lazar Partners (US PR) motiflp@lazarpartners.com
Chantal Beaudry +1 (646) 871-8480
Amy Wheeler +1 (646) 871-8486
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 acute bacterial
skin and skin structure infections (ABSSSI), one of the most common
bacterial infections, with 3.6 million patients hospitalised
annually in the US. 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 chronic pulmonary MRSA infection which mimics
the pathophysiology observed in patients with cystic fibrosis.
Results from this study were presented at IDWeek 2017(TM) on 6
October 2017 in San Diego, CA. 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 U.S. 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 plc'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 plc
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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November 15, 2017 02:00 ET (07:00 GMT)
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