Motif Bio PLC Amendment Agreement with Hercules Capital (3265Q)
18 Febbraio 2019 - 8:00AM
UK Regulatory
TIDMMTFB
RNS Number : 3265Q
Motif Bio PLC
18 February 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.
Motif Bio plc
("Motif Bio" or the "Company")
Motif BioSciences Enters into Amendment Agreement with Hercules
Capital
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced that Motif BioSciences Inc. (a wholly
owned subsidiary) has entered into an amendment agreement with its
lender Hercules Capital, Inc (NYSE:HTGC) ("Hercules") in relation
to the loan agreement as notified on 15 November 2017.
Pursuant to the amendment, Motif BioSciences Inc. will make an
immediate early repayment of $7 million and will make a further
repayment of $0.5 million on the earlier of 90 days, being 18 May
2019, or receipt of funds from an equity raise of $2 million or
greater. There will be a three-month interest-only period on the
remaining loan, and Hercules has waived any applicable prepayment
charges. As a result, future interest and amortisation payments
will be substantially lower than before. Though the Company remains
in compliance with the terms of its loan agreement, it has agreed
to this amendment in order to avoid unilateral action by Hercules
based upon any position that Hercules may take that the Company is
in default.
Following the $7 million repayment, Motif Bio will have cash of
approximately $3 million and $7.7 million of outstanding debt drawn
from the Hercules loan facility. Following this amendment, the
Company intends to manage the funds available to it aggressively
and will need to raise capital in the near term.
Following receipt of a Complete Response Letter (CRL) from the
U.S. Food & Drug Administration (FDA), as notified to the
market on 14 February 2019, the Company has been consulting with
its internal and external experts and is preparing the required
information package to request a meeting with the FDA as soon as
possible to discuss the CRL. As previously stated, once requested,
the FDA typically grants a meeting within 30-45 days. However,
there can be no guarantee as to the date of a meeting with the FDA
and no certainty that the funds available to the Company, without
an additional capital raise, will enable it to reach this date. The
Company is currently assessing the options available to it to raise
sufficient capital to provide cash runway to enable it to meet the
FDA and discuss options to advance iclaprim towards approval.
The Company plans to hold a conference call this week to discuss
recent events and the Company's plans and will provide the details
in due course.
The person who arranged for the release of this announcement on
behalf of Motif Bio plc was Jon Gold, Interim Chief Financial
Officer.
For further information please contact:
Motif Bio plc ir@motifbio.com
Graham Lumsden (Chief Executive Officer)
Peel Hunt LLP (NOMAD & BROKER) + 44 (0)20 7418 8900
Dr Christopher Golden
Oliver Jackson
Walbrook PR Ltd. (UK FINANCIAL PR
& IR) +44 (0)20 7933 8780
Paul McManus/Helen Cresswell/Lianne motifbio@walbrookpr.com
Cawthorne
MC Services AG (EUROPEAN IR) +49 (0) 89 210 2280
Raimund Gabriel raimund.gabriel@mc-services.eu
Russo Partners (U.S. PR) +1 (858) 717-2310 or +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 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 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, (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
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