Motif BioSciences Enters into Amendment Agreement with Hercules Capital
February 18 2019 - 02:00AM
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 Cawthorne |
motifbio@walbrookpr.com |
|
|
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.
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