Motif Bio secures up to US$20 million debt financing
15 November 2017 - 6:00PM
Motif Bio plc (AIM:MTFB) (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) |
|
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Peel Hunt LLP (NOMAD & BROKER)Dr
Christopher GoldenOliver Jackson |
+ 44 (0)20
7418 8900 |
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Northland Capital Partners Limited (BROKER)
Patrick Claridge/ David Hignell John Howes/ Rob Rees
(Broking) |
+44 (0)203 861 6625 |
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Walbrook PR Ltd. (UK FINANCIAL PR & IR) |
+44 (0) 20 7933 8780 / motifbio@walbrookpr.com |
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:MTFB)
(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™ 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 StatementsThis
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.
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