TIDMMTFB
RNS Number : 1811J
Motif Bio PLC
02 April 2015
2 April 2015
Motif Bio plc
("Motif", the "Company" or with its subsidiary the "Group")
First Day of Dealings
Clinical stage biopharmaceutical company developing new
antibiotics admitted to AIM
Motif Bio plc, a clinical stage biopharmaceutical company
specialising in the development of antibiotics, is pleased to
announce that admission and trading of its Ordinary Shares
commences today on AIM with the ticker MTFB.
KEY POINTS:
-- The Company has a lead antibiotic candidate, iclaprim, in
clinical development. The directors anticipate that iclaprim could
be ready for commercialisation within approximately 36 months.
-- The Company is seeking to confirm in meetings with the FDA
and EMA in the first half of 2015, that the clinical development
plan for iclaprim meets regulatory guidelines and that two Phase
III trials can be conducted. A Type C meeting is scheduled with the
FDA for 14 April 2015.
-- Resistance to antibiotics is a major global public health
threat. The world's pipeline of novel antibiotics has not kept pace
with the ability of certain bacteria to resist treatment with
existing products. The Group has a clinical stage antibiotic,
iclaprim, which has been designed to be effective against
multi-drug resistant bacteria.
-- On Admission the Company will have 64,238,442 Ordinary Shares
in issue and a market capitalisation of approximately GBP12.8
million. The Company will have raised GBP2.8 million (before
expenses) by the issue of 12,490,000 Placing Shares at the Placing
Price, and 1,696,140 Subscription Shares at the Subscription
Price.
-- The net proceeds of the Placing and Subscription will be used
to complete preparations to enter Phase III trials with iclaprim
and to provide working capital.
-- The Company comprises an Executive Management Team,
Non-Executive Directors, a Scientific Advisory Board and a team of
scientific consultants covering all of the required drug
development intellectual property and regulatory disciplines needed
to successfully pursue the Group's drug development programmes.
Graham Lumsden, CEO of Motif, commented:
"I am delighted that we have today successfully listed Motif as
planned. Our overriding objectives in becoming a public company
have been to close the merger transaction with Nuprim, granting
Motif exclusive worldwide rights to develop and commercialise
iclaprim, and to raise sufficient funds to complete preparations to
enter Phase III trials with iclaprim. I am pleased to confirm that
we have achieved both objectives.
"We are also pleased to announce that a meeting with the FDA has
been scheduled for 14 April 2015 to discuss the phase III programme
for iclaprim.
"With a new antibiotic at this stage of readiness, Motif is well
placed to benefit from the looming public health crisis by
developing novel antibiotics designed to be effective against
multi-drug resistant bacteria. We are looking forward to keeping
our new shareholders and other investors updated with progress as
we take iclaprim through the various stages of testing and
approvals and onward to commercial success."
Unless the context otherwise requires, defined terms shall have
the meaning ascribed to them in the Admission Document available on
the Group's website: www.motifbio.com
Enquiries:
Motif Bio plc
Graham Lumsden (Chief Executive Officer)
Robert Bertoldi (Chief Financial Officer)
www.motifbio.com
Plumtree Capital (FINANCIAL ADVISER) +44 (0) 207 183
Stephen Austin 5860
+44 (0) 20 7148
Cairn Financial Advisers (NOMINATED ADVISER) 7900
Tony Rawlinson/Liam Murray
+44 (0) 207 382
Northland Capital Partners Limited (BROKER) 1100
Gerry Beaney/David Hignell
John Howes/Mark Treharne
Yellow Jersey PR Limited (FINANCIAL PR)
Dominic Barretto/Philip Ranger/Fiona +44 (0) 7768
Walker 537 739
KEY STATISTICS
Placing Price and Subscription Price (per 20 pence
share)
Existing Ordinary Shares* 50,052,302
Placing Shares 12,490,000
Subscription Shares 1,696,140
Enlarged Share Capital 64,238,442
Placing Shares as a percentage of the Enlarged 19.44 per cent.
Share Capital
Subscription Shares as a percentage of the 2.64 per cent.
Englarged Share Capital
Gross proceeds of the Placing and Subscription GBP2,837,228
Number of Ordinary Shares under Option, Warrant 39,702,610
or convertible pursuant to the CPNs following the Placing,
Subscription and
Admission
Number of Ordinary Shares on a fully diluted 103,941,052
basis following the Placing,
Subscription and
Admission**
Market capitalisation of the Company at Admission GBP12,847,688
at the Placing and Subscription Price
ISIN Code for the Ordinary Shares GB00BVVT4H71
AIM Symbol MTFB
*This number assumes all share issues triggered by Admission
other than the Placing and Subscription will have taken place prior
to Admission.
**On the basis that all Options, Warrants and CPNs in existence
on Admission have been exercised
Introduction
The Company is a clinical stage biopharmaceutical company which
specialises in developing novel antibiotics designed to be
effective against serious and life-threatening infections caused by
multi-drug resistant bacteria. The Company will, on Admission, have
a lead antibiotic candidate, iclaprim, in clinical development and
MTF-001, a preclinical stage programme, to design a best-in-class
DHFRi. Discussions and negotiations with academic institutions and
pharmaceutical companies are under way to build a portfolio of
antibiotic candidates through licensing. The Group's main area of
operation is the US.
The Company is seeking to confirm in meetings with the FDA and
EMA in the first half of 2015, that the clinical development plan
for iclaprim meets regulatory guidelines and that two Phase III
trials can be conducted. A Type C meeting has been scheduled with
the FDA for 14 April 2015. Upon confirmation of the clinical
development plan and subject to funding being available, the two
Phase III trials are planned to be initiated in the second half of
2015.
Subject to funding being available, the Directors anticipate
that iclaprim could be ready for commercialisation within
approximately 36 months.
The Company has built a team of scientists and experts with
extensive drug development experience and is raising approximately
GBP2.1 million net of expenses through the Placing and Subscription
to provide the Group with capital to complete preparations to
commence Phase III trials with iclaprim and to provide the Group
with additional working capital. Additional funding will be needed
to carry out the two Phase III clinical trials on iclaprim and to
progress the Group's other drug development programmes.
Group Structure and History
Originally founded as a population genetics company, Motif, Inc.
has, since 2009, focused on drug discovery and development. A team
of expert scientists was assembled in 2009/2010 with the goal of
identifying first-in-class pharmaceutical compounds with
significant flaws or deficits that could be fixed using tractable
synthetic chemistry. Medicinal chemistry plans and research
operating plans were completed for three development programmes -
an antibiotic, a product to treat rheumatoid arthritis and a drug
for overactive bladder. In each case, a strategy to develop a
best-in-class compound was mapped out with the aim of identifying
patentable lead compounds within approximately 18 months. On 13
June 2012, a collaboration agreement was executed with Jubilant,
pursuant to which Jubilant provides laboratory facilities and
personnel to Motif, Inc. to assist in developing one of the three
best-in-class compounds (MTF-001): a DHFRi designed to be effective
against MRSA and multi-drug resistant bacteria. In late 2013, it
was decided that Motif, Inc. should focus exclusively on
antibiotics.
In December 2014 Motif, Inc. began its evolution from a
preclinical stage company to a late stage clinical company by
entering into the Nuprim Merger Agreement. Pursuant to the Nuprim
Merger Agreement, Motif, Inc. conditionally agreed to merge with
Nuprim, a Maryland corporation owning the exclusive worldwide
rights to a potential novel antibiotic called iclaprim, into Motif,
Inc. The completion of this merger is subject to Admission.
Iclaprim completed clinical development and in 2008 a NDA and a MAA
were submitted seeking approval to market in the US and EU,
respectively. In 2009 the FDA declined to approve iclaprim based on
the data submitted and subsequently the MAA was withdrawn in
Europe. The scientific experts at Motif, Inc. have reviewed the
data package for iclaprim and have concluded that by addressing
certain def iciencies in the original development programme,
iclaprim can be returned to clinical development and re-submitted
for review by the FDA and by the EMA. Providing funding is
available to complete the Phase III trials and regulatory approval
is granted, the Directors anticipate that iclaprim could be
marketed within approximately 36 months.
Business and Investment Opportunity
The net proceeds of the Placing and Subscription will be used to
complete preparations to enter Phase III trials with iclaprim and
to provide working capital. An additional fundraising or a
strategic partnership with another pharmaceutical company is
planned for later in 2015 in order to raise additional capital and
fund the Phase III trials with iclaprim.
Resistance to antibiotics is a major global public health
threat. The world's pipeline of novel antibiotics has not kept pace
with the ability of certain bacteria to resist treatment with
existing products. The Group has a clinical stage antibiotic,
iclaprim, which has been designed to be effective against
multi-drug resistant bacteria.
Iclaprim is being designed to be administered in hospitals as an
intravenous infusion. The Directors believe the most urgent need
for novel antibiotics effective against multi-drug resistant
bacteria is in the hospital setting where patients often succumb to
serious, life-threatening infections that require immediate
treatment with the best available antibiotic. In the case of HABP,
mortality rates for infected patients are currently between 20 per
cent. and 50 per cent. Extended hospital stays pose a burden to
healthcare systems and can increase hospital costs by an average of
approximately GBP26,000 per patient. In the Directors' experience,
commercialisation of hospital products is relatively easy and can
be done with fewer resources than commercialisation in the
community because there are fewer hospital healthcare professionals
to communicate with, compared to launching and educating the larger
number of primary care and general practitioners in most
countries.
Assuming that Motif, Inc. receives regulatory approval to start
Phase III testing in the second half of 2015, the Directors believe
that iclaprim offers a rapid path to commercialisation, which could
be expected to occur in 2018 subject to funding or a strategic
partnership with a pharmaceutical company. A follow-on pipeline of
preclinical antibiotics is being built to follow iclaprim as
additional funding becomes available. Should the FDA approval be
delayed or rejected, the Directors would consider alternative plans
to progress iclaprim and would also focus on progressing the
Company's other pre-clinical drug programmes.
Recent mergers and acquisitions demonstrate the increased
activity within the antibiotic field. Paratek listed on Nasdaq in
2014, raising approximately US$100 million to develop a
tetracycline antibiotic called omadacycline, whose Phase III
studies are set to re-start in the first half of 2015. Paratek's
market cap increased to approximately US$574 million following the
acquisition in January 2015 of Cubist by Merck & Co., Inc. for
US$9.5 billion. Durata Therapeutics Inc. (NASDAQ: DRTX) was
acquired by Actavis (NYSE: ACT) in October 2014 for US$675 million
plus contingent value rights, following the approval for its first
antibiotic in May 2014.
The Directors believe, assuming that iclaprim successfully
completes Phase III trials, that the Company should be an
attractive candidate for a strategic partnership with a large
pharmaceutical company with commercialisation expertise and
capabilities.
Scientific and Market Background
Resistance to antibiotics is a major global health threat.
So-called "superbugs" are developing resistance to currently
available antibiotics faster than new, effective antibiotics are
being developed. In June 2013, Dr Margaret Chan, Director-General
of the World Health Organisation stated that, "a post-antibiotic
era means, in effect, an end to modern medicine as we know it.
Things as common as strep throat or a child's scratched knee could
once again kill. Some sophisticated interventions, like hip
replacements, organ transplants, cancer chemotherapy, and care of
preterm infants, would become far more difficult or even too
dangerous to undertake."
The worldwide antibacterial market was valued at US$43.9 billion
in 2010. There are many antibiotics in the market today and two
have annual sales of more than US$1 billion, Zyvox (linezolid,
Pfizer) and Cubicin (daptomycin, Merck & Co.). Since iclaprim
was designed to be effective against bacteria resistant to
trimethoprim, the only other commonly used antibiotic with the same
mechanism, iclaprim should be well positioned to compete in this
commercially attractive market. The GAIN Act, which was signed into
law on 9 July 2012, mandates faster review times at the FDA and
grants new antibiotics an additional 5 years on top of the 5 years
of "Hatch-Waxman" exclusivity giving a total of 10 years of market
exclusivity from the date of approval in the US.
Product Portfolio
The Group is committed to helping resolve the looming public
health crisis by developing novel antibiotics designed to be
effective against multi-drug resistant bacteria. The initial focus
of the Group's team is on the development of iclaprim.
Information on iclaprim
Iclaprim is a potential novel antibiotic, designed to be
effective against bacteria that have developed resistance to other
antibiotics, including trimethoprim, the only other commonly used
antibiotic that shares the same mechanism. Iclaprim is bactericidal
and has a low risk for resistance development. Originally
discovered by F. Hoffman-La Roche Ltd, iclaprim is a DHFRi.
Iclaprim was licensed to and developed by Arpida AG ("Arpida") and
in 2008, a request to the FDA and the EMA was submitted for
approval to market the compound. On the basis of the submitted
data, iclaprim was not approved and ceased to be developed.
The Group has completed due diligence, including a review of the
preclinical and clinical data plus the US and European regulatory
correspondence, and the Directors believe that iclaprim can be
rapidly returned to late stage clinical testing with some
improvements to the original development programme. The final
clinical development plan will be confirmed in meetings with the
FDA and the EMA, which are expected to take place within 6 months
of Admission. The Group has a copy of the "Complete Response
Letter" received by Arpida in January 2009 which confirms the
reasons that iclaprim was not approved by the FDA based on the data
submitted in 2008. This confidential information, together with the
improved regulatory environment and the need for novel antibiotics
that are effective against multi-drug resistant bacteria, support
the Group's plan for a rapid return to clinical development for
iclaprim.
Assuming that funds can be raised (or a partnership be entered
into) to carry out clinical development and that the clinical
trials are successful, the Directors believe that it is feasible to
achieve approval to market within 36 months.
Regulatory background
Iclaprim completed clinical development and marketing
applications to the FDA and the EMA were submitted in 2008. At that
time and based on the data submitted, iclaprim failed to gain
approval from the FDA or the EMA. Three other new antibiotics also
failed to gain approval for commercialisation around this time:
dalbavancin, oritavancin and omadacycline. Additional clinical
trials were completed with dalbavancin and oritavancin and they
were both approved by the FDA in May and August 2014 respectively.
Omadacycline is expected to re-enter the Phase III trials in the
first half of 2015.
In 2007, telithromycin (Ketek) was approved as a novel
antibiotic, and then associated with severe liver injury and
fraudulent safety data which resulted in two of three Ketek
indications being withdrawn and the Directors believed this led to
a slowdown in new drug approvals. In recent years, the Directors
believe that the regulatory environment for antibiotics has become
more favourable to the approval of potential antibiotic compounds.
The urgent need for novel antibiotics is well recognised, with the
passing in 2012 of the GAIN Act, which mandates accelerated
approval times and extended market exclusivity in the US, and the
publication by the FDA of revised, clear clinical trial guidelines.
The Directors believe this development is a major improvement
compared to the situation at the time of the earlier antibiotic
submissions in 2008 and that this greatly enhances the likelihood
of approval, assuming that the clinical trials are completed
successfully.
Next steps
Iclaprim: Motif, Inc. has developed a clinical and regulatory
strategy which the Directors believe addresses the def iciencies in
the original development programme, with the intention of
re-entering clinical testing with an i/v formulation for use in
hospitals. The Company is seeking to confirm in meetings with the
FDA and the EMA in the first half of 2015 that the clinical
development plan for iclaprim meets regulatory guidelines and that
two Phase III trials can be conducted as proposed. A Type C meeting
has been scheduled with the FDA for the 14 April 2015. Similar
discussions are planned to take place with the EMA in the first
half of 2015.
The two initially proposed indications are:
-- ABSSSI, a common serious infectious disease involving
multi-drug resistant bacteria. Within the US hospitalised patients,
skin and soft tissue infections were estimated to have increased by
176 per cent. from 1997 to 2009. The two Phase III trials with
iclaprim, completed in 2008, demonstrated efficacy and safety in
patients with cSSSI; and
-- HABP, a serious infection with a mortality rate between 20
per cent. and 50 per cent. and can lead to an increase hospital
costs by an average of approximately GBP26,000 per patient.
Iclaprim's Phase II trial demonstrated excellent efficacy in
patients with HABP and iclaprim was more effective and led to fewer
drug-related adverse events than those treated with vancomycin.
The two trial protocols have been developed to be consistent
with the latest published FDA and EMA guidelines.
Upon confirmation of the clinical development plan, the first of
the two Phase III trials is planned to be initiated in the second
half of 2015. The existing API is being re-qualified to ensure
adherence to current global regulations for characterisation of
compounds for clinical use. Assuming that this existing material
can be used to manufacture clinical trial supplies, the Phase III
programme will be ready to start before the end of 2015. Once the
clinical development plan is finalised following the FDA and EMA
meetings, including the number of patients required to be included,
and negotiations with CROs have been completed, the final clinical
costs will be confirmed.
The Company is intending to seek to raise additional capital or
enter into a strategic partnership with another pharmaceutical
company in order to fund the Phase III trials. Several development
programmes and indications will be undertaken with the iclaprim
assets and the Directors' ambition is to have other new
indications, formulations and combinations in clinical development
by the end of 2016.
Reasons for Placing, Subscription and Admission
The net proceeds of the Placing and Subscription will assist the
Group in its development by providing funding to advance iclaprim
to be ready to re-enter Phase III trials and to provide working
capital. The two Phase III clinical trials for iclaprim (as
described above, in this Part I) will be funded following Admission
and possibly through a strategic partnership with another
pharmaceutical company.
The Directors believe that Admission will assist the Group in
its development by:
-- enabling the Group to complete development work prior to
initiation of the first Phase III trial with iclaprim, subject to
regulatory approval;
-- raising its profile in the sector in which it operates;
-- increasing access to capital required to fund further product
development and clinical trials; and
-- providing a market on which the Ordinary Shares can be
traded, which will give increased liquidity and potentially a
market valuation for the Company's equity which, in conjunction
with the employee option schemes, will assist the Group in
attracting, retaining and incentivising high calibre employees.
Details of the Placing and Subscription
On Admission the Company will have 64,238,442 Ordinary Shares in
issue and a market capitalisation of approximately GBP12.8 million.
The Company will have raised GBP2.8 million (before expenses) by
the issue of 12,490,000 Placing Shares at the Placing Price, and
1,696,140 Subscription Shares at the Subscription Price.
Directors and Key Management
The Company's Board is comprised as follows. Further details on
the Directors are set out in the Admission Document.
Richard Cecil Eversfield Morgan, Non-Executive Chairman (aged
70)
Richard Morgan is Chairman of the Company and is also Chief
Executive Officer of Amphion. Amphion is the successor firm to
VennWorks LLC and Amphion Capital Partners LLC, which Mr Morgan
also co-founded. Over the course of his career, Mr Morgan has been
directly involved in the start-up and development of more than 30
companies in the information technology, healthcare and
biotechnology industries. These include MediSense, Sequus
Pharmaceuticals, Celgene, Quidel and Vortech Data. Prior to this Mr
Morgan spent 15 years with Schroders plc as a board member and head
of the Schroders Strategy Group, which he founded. Mr Morgan was a
co-founder of Celgene Corporation, and held a board position with
the company from 1987 to 2008. Mr Morgan currently serves as
Chairman of four other Amphion Partner Companies (Axcess, FireStar,
Private Markets and WellGen) and is also a director of
DataTern.
Graham George Lumsden, Chief Executive Officer (aged 55)
Graham Lumsden, Chief Executive Officer of the Company, is
responsible for all aspects of the strategy, management, and
operations of the Company. Prior to joining the Company, Mr Lumsden
was a senior executive at Merck & Co., Inc. where he held
commercial leadership positions in multi-billion dollar worldwide
businesses. Mr Lumsden has a proven record of success leading
change and delivering results in subsidiary and global leadership
positions, including new product launches, pre-clinical and
clinical development, regulatory strategy, IP strategy and
litigation, and strategic sales and marketing. Mr Lumsden is a
member of the Royal College of Veterinary Surgeons (MRCVS), holds a
postgraduate diploma from the Chartered Institute of Marketing
(MCIM) and is a dual citizen of the UK and US.
Robert ("Bob") Joseph Bertoldi, Chief Financial Officer (aged
60)
Bob Bertoldi is Chief Financial Officer of the Company. He is
also Chief Financial Officer of Amphion and was a founder President
and continues to be the Chief Financial Officer of Amphion Capital
Partners LLC (the predecessor of Amphion) and VennWorks LLC. Mr
Bertoldi is also a general partner of Amphion Partners LLC
(formerly known as Wolfensohn Partners, LP). Prior to that, Mr
Bertoldi served as Chief Financial Officer for James D. Wolfensohn,
Inc. and Hambro America Inc. Mr Bertoldi currently serves as a
director of three other Amphion Partner Companies, m2m, WellGen and
Axcess and is also a director of DataTern. Mr Bertoldi began his
career at KPMG and left as a manager in the investment services
department. Mr Bertoldi obtained a B.A. in Accounting and Economics
from Queens College, New York in 1976 and became a Certified Public
Accountant in 1978. He is a member of the AICPA and NYSCPA.
-- Bruce Andrew Williams, Non-Executive Director (aged 60)
-- Dr Mary Lake Polan, Non-Executive Director (aged 71)
-- Dr John Wilbur Stakes III, Non-Executive Director (aged 65)
-- Zaki Hosny, Non-Executive Director (aged 66)
-- Charlotta Ginman-Jones, Non-Executive Director (aged 49)
-- Jonathan Gold, Non-Executive Director (aged 42)
-- Dr David Huang, Chief Medical Officer (aged 40)
Scientific Advisory Board
The Scientific Advisory Board consists, at the time of
Admission, of four qualified experts, three of whom are experienced
anti-infective clinicians. The Scientific Advisory Board provides
independent expert advice and guidance to the Company.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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