TIDMMTFB
RNS Number : 0118E
Motif Bio PLC
13 July 2016
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART
DIRECTLY OR INDIRECTLY IN, INTO OR FROM ANY JURISDICTION WHERE TO
DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR
REGULATIONS OF SUCH JURISDICTION
This announcement contains inside information.
Motif Bio plc
("Motif Bio" or the "Company")
13 July 2016
MOTIF BIO PUBLISHES CIRCULAR FOR AUTHORITY TO ALLOT UP TO 100
MILLION ORDINARY SHARES PURSUANT TO A PROPOSED US OFFERING
Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical
company specialising in developing novel antibiotics, announces
that it is to publish today a Circular seeking authority to allot
up to 100 million Ordinary Shares pursuant to a Proposed US
Offering. The Circular providing details of the Proposed US
Offering will be posted to Shareholders, together with a Notice of
General Meeting, today and will be available on the Company's
website at www.motifbio.com.
For further information please contact:
Motif Bio plc info@motifbio.com
Richard Morgan (Chairman)
Graham Lumsden (Chief
Executive Officer)
Zeus Capital Limited (NOMAD
& BROKER)
Phil Walker/Giles Balleny
Dominic Wilson +44 (0)20 3829 5000
Northland Capital Partners
Limited (BROKER)
Patrick Claridge/ David
Hignell
John Howes/ Rob Rees (Broking) +44 (0)20 3861 6625
Walbrook PR Ltd. (FINANCIAL +44 (0)20 7933 8780 or motifbio@walbrookpr.com
PR & IR) Mob: +44 (0)7980 541 893
Paul McManus Mob: +44 (0)7900 608 002
Mike Wort
MC Services AG (EUROPEAN
IR)
Raimund Gabriel +49 (0)89 210 2280
About Motif Bio
Motif Bio 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. Our
lead product candidate, iclaprim, is being developed for the
treatment of acute bacterial skin and skin structure infections
(ABSSSI) and hospital acquired bacterial pneumonia (HABP),
including ventilator associated bacterial pneumonia (VABP), which
is often caused by MRSA (methicillin resistant Staphylococcus
aureus). We are currently enrolling and dosing patients in two
global Phase 3 clinical trials with an intravenous formulation of
iclaprim, for the treatment of ABSSSI, which are expected to
complete in the second half of 2017.
Forward Looking Statements
This document contains "forward-looking statements" which
include all statements other than statements of historical facts,
including, without limitation, those regarding the Group's
financial position, business strategy, plans and objectives of
management for future operations, or any statements preceded by,
followed by or that include the words "targets", "believes",
"expects", "aims", "intends", "will", "may", "anticipates",
"would", "could" or "similar" expressions or negatives thereof.
Such forward-looking statements involve known and unknown risks,
uncertainties and other important factors beyond the Company's
control that could cause the actual results, performance or
achievements of the Group to be materially different from future
results, performance or achievements expressed or implied by such
forward-looking statements. Such forward-looking statements are
based on numerous assumptions regarding the Group's present and
future business strategies and the environment in which the Group
will operate in the future. These forward-looking statements speak
only as at the date of this document. The Company expressly
disclaims any obligation or undertaking to disseminate any updates
or revisions to any forward-looking statements contained herein to
reflect any change in the Company's expectations with regard
thereto or any change in events, conditions or circumstances on
which any such statements are based unless required to do so by
applicable law or the AIM Rules for Companies
1. INTRODUCTION
The Company has announced today that it has filed a registration
statement on Form F-1 with the SEC as part of the Company's plan to
conduct the Proposed US Offering. Currently, the exact timing of
the Proposed US Offering, the number of, and the price range for,
the ADSs to be offered and sold in the Proposed US Offering have
not been determined. The Proposed US Offering is subject to the SEC
satisfactorily completing its review process, and will be subject
to market and other conditions and there is no assurance that the
Proposed US Offering will be completed or successful. The Company
has applied to list the ADSs on NASDAQ and application will also be
made to the London Stock Exchange for the Proposed US Offering
Shares to be admitted to trading on AIM. The Company's Ordinary
Shares will continue to be traded on the AIM market of the London
Stock Exchange.
The Directors believe that the Proposed US Offering will provide
the Company the opportunity to continue to build value for existing
shareholders and will provide access to further capital to enable
the Company to complete the Phase III clinical trials currently
underway with iclaprim in patients with ABSSSI and, depending on
the proceeds raised, to initiate dosing of the first patient in an
additional Phase III clinical trial with iclaprim in patients with
HABP, including patients with VABP.
In due course, the Company will be required to allot and issue
Ordinary Shares for the Proposed US Offering. As such, in order to
minimise any delay in completing the Proposed US Offering the
Directors are seeking authority in advance of the Proposed US
Offering to allot and issue the Proposed US Offering Shares and
permit the disapplication of statutory pre-emption rights in
respect of the allotment of the Proposed US Offering Shares.
Further details on the Proposed US Offering are set out below.
However, it should be noted that there is no assurance that the
Proposed US Offering will be completed or successful.
The purpose of the Circular is for the Directors: (i) to explain
the background to and reasons for the Proposed US Offering; (ii) to
explain why they are seeking authority from you, the Shareholders,
to issue the Proposed US Offering Shares for cash on a
non-pre-emptive basis; and (iii) to recommend that you, the
Shareholders, vote in favour of the Resolutions.
2. BACKGROUND TO AND REASONS FOR THE PROPOSED US OFFERING
Motif Bio 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 which are caused by multi drug resistant
bacteria. Our lead product candidate, iclaprim, is being developed
for the treatment of infections caused by MRSA and other
Gram-positive bacteria. The first two indications will be acute
bacterial skin and skin structure infections ("ABSSSI") and
hospital acquired bacterial pneumonia ("HABP"). We are currently
enrolling and dosing patients in two global Phase III clinical
trials with an IV formulation of iclaprim for the treatment of
ABSSSI.
Recent Developments
Since its initial public offering in April 2015, the Group has
made significant progress in the clinical development of iclaprim
with a view to bringing this novel antibiotic to market, in
particular:
l the FDA agreed to the commencement of Phase III trials of
iclaprim for ABSSSI and HABP in April 2015;
l in July 2015 the FDA granted QIDP designation for iclaprim in
ABSSSI and HABP and a successful placing was undertaken raising
GBP22 million (before expenses) for the Company at 50 pence per
share;
l the FDA granted Fast Track designation for iclaprim IV to
treat ABSSSI and HABP in September 2015;
l October 2015 saw Motif Bio engage Covance, a global leading
CRO, to conduct the Phase III clinical trials to evaluate the
efficacy and safety of IV iclaprim versus IV vancomycin in the
treatment of ABSSSI; and
l Motif Bio dosed the first patient in the Phase III iclaprim
trials for ABSSSI in March 2016.
ABSSSI
The Company, with the agreement of the FDA and MEB, has
initiated two Phase III global trials (REVIVE-1 and REVIVE-2) to
study iclaprim for the treatment of ABSSSI compared to vancomycin,
the standard of care treatment for Gram positive hospitalised
infections caused by MRSA. Vancomycin accounts for approximately 73
per cent. of the days of therapy for hospitalised Gram-positive
infections in the U.S.(1) . The two global, 600 patient,
randomised, double blind Phase III trials each have two arms with
patients assigned to receive either iclaprim or vancomycin. A fixed
dose of 80 mg of iclaprim, based on modelling and simulation of
pharmacokinetic data from the previous Phase III clinical trials of
iclaprim in cSSSI, was agreed with the FDA and MEB. It is believed
that this dose will optimise the potential clinical efficacy and
safety outcomes for the REVIVE 1 and REVIVE 2 studies. Patients can
be included in the clinical trials if they have a skin lesion with
a minimum size of 75 cm(2) . The FDA primary endpoint to
demonstrate effectiveness is at least a 20 per cent. reduction in
lesion size at 48-72 hours. The EMA primary endpoint is clinical
cure at one to two weeks after antibiotic treatment ends.
Achieving these two endpoints in the two pivotal Phase III
trials would be expected to satisfy both FDA and EMA requirements
for regulatory submission, enabling the Company to submit an NDA in
the United States and an MAA in Europe for an IV formulation of
iclaprim for the treatment of ABSSSI caused by Gram positive
pathogens, including resistant strains such as MRSA. The Directors
believe that, if approved, iclaprim can become a valuable addition
to the formulary of life saving antibiotics used by hospital
physicians. In addition, up to 26 per cent. of high-risk
hospitalised ABSSSI patients suffer from kidney disease and
vancomycin has been associated with nephrotoxicity and requires
dose adjustment depending on the severity of kidney disease.
Iclaprim has not been associated with nephrotoxicity and requires
no dosage adjustment, offering an appropriate alternative for these
patients.
Iclaprim has received QIDP and Fast Track designations for the
treatment of ABSSSI and HABP under the GAIN Act. These designations
make iclaprim eligible to benefit from certain incentives including
FDA priority review, and if ultimately approved by the FDA, an
additional five-year extension of Hatch-Waxman exclusivity,
resulting in a total of 10 years of market exclusivity, starting
from the date of NDA approval.
The Company intends to pursue the Proposed US Offering to secure
funding required to complete the Phase III clinical trials for the
treatment of ABSSSI.
1 Source: Market share estimated using multiple data sources,
including IMS Health, 3 year sales and unit trend data for selected
Gram positive anti-bacterial through December 2015
HABP
The Company is preparing its INSPIRE Phase III clinical trial
with iclaprim in patients with HABP, including patients with VABP.
Based on data from a Phase II clinical trial which demonstrated
iclaprim's efficacy in this patient population, we believe that
iclaprim is well suited for use as a first line empiric therapy for
patients with HABP, including patients with VABP. Additionally, in
a Phase I healthy volunteer trial concentrations of iclaprim at the
site of infection in the lungs were considerably higher than
concentrations in plasma. The Company intends to use a portion of
the proceeds from the Proposed US Offering to complete its
preparations for the INSPIRE Phase III clinical trial and,
depending on the proceeds raised, to initiate dosing of the first
patients in the INSPIRE Phase III trial itself.
The Company plans to complete preparations for its INSPIRE Phase
III clinical trial with iclaprim in patients with HABP, including
patients with VABP, by the end of 2016. Subject to the availability
of funding, the Company would look to start dosing patients
thereafter. The Board will continue to explore further funding
options, in addition to the Proposed US Offering, including
strategic partnerships with other pharmaceutical companies and
non-dilutive government funding from grants.
3. DETAILS OF THE PROPOSED US OFFERING
The Company is seeking to raise funds through the Proposed US
Offering and has filed a registration statement with the SEC in
connection therewith. However the timing of the Proposed US
Offering, and the precise determination of the number and price of
ADSs to be offered by the Company, will be determined by the
Directors during the offering process. There is no assurance that
the Proposed US Offering will be completed or successful. In the
event that the Company were to sell all 100 million Proposed US
Offering Shares, based on the closing mid-market price of 45.25
pence, the price of an Ordinary Share on 12 July 2016, the Company
would receive GBP45.25 million (approximately US$60 million) in
gross proceeds.
The ADSs are negotiable instruments issued by Bank of New York
Mellon, a depositary bank, and represent ownership of Ordinary
Shares. Each of the offered ADSs will represent an exact number of
Ordinary Shares. This number will be determined by the Directors
during the offering process.
There will be no offer to the public in the United Kingdom
(including to the Company's existing Shareholders generally) of
ADSs or Ordinary Shares in connection with the Proposed US
Offering. A limited number of institutional shareholders of the
Company may participate in the Proposed US Offering.
The Proposed US Offering is subject to, inter alia, the passing
of Resolutions 1 and 2 as set out in paragraph 6 below. The
Directors are requesting authority to issue up to 100 million
Ordinary Shares in aggregate in connection with the Proposed US
Offering or by way of a separate Placement. The Directors are keen
to ensure that the Company is as well funded as possible to enable
it to complete the Phase III ABSSSI trials and to complete the
preparations for, and subject to available funding, initiate dosing
of the first patients in the Phase III HABP, including VABP, trial.
In granting authority to the Directors to issue the Proposed US
Offering Shares in the Proposed US Offering or by way of a
Placement at a later date, but in any event before 31 December
2016, the Shareholders will be granting the Directors the
flexibility to issue the Proposed US Offering Shares at any time
that funds are available from potential investors.
An existing Shareholder, Invesco Asset Management Limited
("Invesco"), which acts as agent for and on behalf of its
discretionary managed clients and beneficially owns approximately
25% of the Existing Ordinary Shares, has indicated an interest in
participating in the Proposed US Offering. Assuming a Proposed US
Offering of US$35 million, Invesco has indicated an interest in
purchasing up to an aggregate of $8.89 million of ADSs in the
Proposed US Offering at the public offering price per ADS. The
underwriters will receive a reduced underwriting discount in
respect of ADSs sold to this existing institutional Shareholder.
However, because indications of interest are not binding agreements
or commitments to purchase, the underwriters may determine to sell
more, less or no ADSs in this offering to Invesco, or Invesco may
determine to purchase more, less or no ADSs in this offering.
4. USE OF PROCEEDS
The net proceeds of the Proposed US Offering will be used as
follows:
The first US$35 million will be used to:
4.1 fund the expenses to be incurred in completing the two Phase
III clinical trials of iclaprim for the treatment of ABSSSI;
4.2 prepare a Phase III clinical trial of iclaprim for the treatment of HABP, including VABP; and
4.3 fund working capital, general and administrative expenses,
research and development expenses, and other general corporate
purposes.
If more than US$35 million is raised, the Company intends to use
the additional proceeds to initiate dosing of the first patients in
the INSPIRE Phase III clinical trial.
The Company will require further capital in order to complete
the Phase III HABP, including VABP, trial and the Board will
continue to explore further funding options, including the issuance
of additional securities as well as strategic partnerships with
other pharmaceutical companies and non-dilutive government funding
from grants.
5. CURRENT PROSPECTS AND OUTLOOK
Over the last 12 months, since the Company's GBP22 million
placing in July 2015, the Group has continued to focus on the
development of iclaprim, and therefore no revenue has been
generated in the review period. The Group's largest expenditure has
been on research and development costs including external clinical
development costs and general and administrative costs, which
include expenses charged by Amphion US, and outside consultancy
fees from partners and engaged consultants who lead the development
of products.
The Directors believe that the Company's prospects remain
positive and confirm that since the Company's Final Results for the
year ended 31 December 2015, which were announced on 20 April 2016,
and as reflected in the unaudited results for the three month
period to 31 March 2016, which are set out below, the Company has
continued to progress in line with expectations.
6. GENERAL MEETING
A notice is set out at the end of the Circular convening the
General Meeting to be held at the offices of Reed Smith LLP at The
Broadgate Tower, 20 Primrose Street, London EC2A 2RS on 1 August
2016 at 2.00 p.m. at which the following Resolutions will be
proposed:
(A) Resolution 1, which will be proposed as an ordinary
resolution, is to authorise the Directors to allot relevant
securities up to an aggregate nominal value of GBP1.0 million (100
million Ordinary Shares) in connection with the Proposed US
Offering or a subsequent Placement; and
(B) Resolution 2, which will be proposed as a special resolution
and which is subject to the passing of Resolution 1, is to disapply
statutory pre-emption rights, provided that such authority shall be
limited to the allotment of equity securities in connection with
the Proposed US Offering or a subsequent Placement up to an
aggregate nominal amount of GBP1.0 million (100 million Ordinary
Shares).
The authority and power conferred by these Resolutions will
expire on 31 December 2016. The powers and authorities which will
be given to the Directors by Resolutions 1 and 2, if passed, will
be in addition to the existing authority to allot Ordinary Shares
conferred to Directors at the Company's 2016 Annual General Meeting
(held on 2 June 2016) but it is emphasised that the powers and
authorities sought at the General Meeting are exercisable only in
connection with the Proposed US Offering. The new authorities and
powers are being sought due to the uncertainty as to the final size
and price of the Proposed US Offering.
7. ACTION TO BE TAKEN
Shareholders should check that they have received the following
with the Circular:
l a Form of Proxy for use in relation to the General Meeting;
and
l a reply-paid envelope for use in connection with the return of
the Form of Proxy (in the UK only).
Whether or not they intend to be present in person at the
General Meeting, Shareholders are strongly encouraged to complete,
sign and return your Form of Proxy in accordance with the
instructions printed thereon so as to be received by post or,
during normal business hours only, by hand, at Share Registrars
Limited of The Courtyard, 17 West Street, Farnham, Surrey GU9 7DR,
United Kingdom, as soon as possible but in any event so as to
arrive by not later than 2.00 p.m. on 28 July 2016 (or, in the case
of an adjournment of the General Meeting, not later than 48 hours
before the time fixed for the holding of the adjourned meeting
(excluding any part of a day that is not a business day)).
Shareholders appointing a proxy in accordance with the
instructions set out above will enable their vote to be counted at
the General Meeting in the event of their absence. The completion
and return of a Form of Proxy will not preclude a Shareholder from
attending and voting in person at the General Meeting, or any
adjournment thereof, should they wish to do so.
8. RECOMMATION AND IRREVOCABLE UNDERTAKINGS
The Directors consider the Proposed US Offering to be in the
best interests of the Company and its Shareholders as a whole and
accordingly unanimously recommend that Shareholders vote in favour
of the Resolutions to be proposed at the General Meeting as they
intend to do in respect of their own beneficial holdings amounting,
in aggregate, to 859,675 Existing Ordinary Shares, representing
approximately 0.79 per cent. of the Existing Ordinary Shares.
In addition to the Directors, certain other shareholders, have
irrevocably undertaken to vote in favour of the Resolutions in
respect of the Existing Ordinary Shares in which they are
interested, amounting in aggregate to 55,920,875 Existing Ordinary
Shares, representing approximately 51.49 per cent. of the Existing
Ordinary Shares.
EXPECTED TIMETABLE OF PRINCIPAL EVENTS(1)
The Circular posted to Shareholders (by first class post) 13
July 2016
Latest time and date for receipt of Form of Proxy 2.00 p.m. on
28 July 2016
General Meeting 2.00 p.m. on 1 August 2016
EXCHANGE RATE
The exchange rate used throughout this document, unless
otherwise stated, is approximately GBP1 = US$1.33, being the
closing rate on 12 July 2016, being the last practicable date prior
to publication of this document.
Notes:
1. Each of the times and dates above are indicative only and if
any of the details contained in the timetable above should change,
the revised times and dates will be notified to Shareholders by
means of an announcement through a Regulatory Information
Service.
DEFINITIONS
The following words and expressions shall have the following
meanings in this document unless the context otherwise
requires:
"Admission" the admission to trading on NASDAQ of the ADSs;
"ADSs" American Depositary Shares, each of which will consist of
a fixed number
of Ordinary Shares (which is yet to be determined) or a right to
receive a fixed number of Ordinary Shares (which is yet to be
determined), proposed to be issued pursuant to the Proposed US
Offering, to be registered and issued by the Bank of New York
Mellon;
"AIM" the AIM market operated by the London Stock Exchange;
"Amphion" Amphion Innovations plc, a public limited company
incorporated and
registered in the Isle of Man with registered number 113646C,
whose
registered office is at Fort Anne, Douglas, Isle of Man, IM1
5PD;
"Amphion US" Amphion Innovations US Inc., a domestic for profit
corporation
incorporated in the US state of Delaware on 19 August 2005
with
corporation number 4018201 and having its registered office at
2711
Centerville Road Suite 400, Wilmington, Newcastle, DE 19808;
"Board" or "Directors" Richard Morgan, Graham Lumsden, Robert
Bertoldi, Charlotta Ginman-
Horrell, Jonathan Gold, Zaki Hosny, Mary Lake Polan and Bruce
Williams and a "Director" means any one of them;
"Circular" this circular prepared in relation to the General
Meeting;
"Company" or "Motif Bio" Motif Bio plc, a company registered in
England and Wales with registered
number 09320890 and having its registered office at One Tudor
Street,
London EC4Y 0AH;
"CREST" the computerised settlement system to facilitate
transfer of title to or
interests in securities in uncertificated form operated by
Euroclear UK &
Ireland Limited;
"Enlarged Share Capital" the entire issued ordinary share
capital of the Company immediately
following Admission;
"Existing Ordinary Shares" the 108,601,496 Ordinary Shares
currently in issue at the date of this
document;
"Form of Proxy" the form of proxy for use at the General Meeting
which accompanies the Circular;
"General Meeting" the general meeting of the Company, notice of
which is set out at the end of the Circular;
"Group" the Company and its subsidiary undertakings prior to
Admission;
"London Stock Exchange" London Stock Exchange plc;
"Market Abuse Regulation" Regulation (EU) No 596/2014 of the
European Parliament and of the
Council of 16 April 2014 on market abuse;
"NASDAQ" The NASDAQ Global Select Market;
"Notice of General Meeting" the notice of the General Meeting,
which is set out at the end of the
Circular;
"Ordinary Shares" ordinary shares of one penny each in the share
capital of the Company;
"Placement" a placement of Ordinary Shares with investors
following the completion of the
Proposed US Offering but prior to 31 December 2016;
"Proposed US Offering" the proposed US registered public
offering of up to 100 million Ordinary
Shares to be represented in the form of ADSs;
"Proposed US Offering Shares" up to 100 million Ordinary Shares
represented by ADSs to be issued by
the Company pursuant to the Proposed US Offering;
"Registrars" Share Registrars Limited of The Courtyard, 17 West
Street, Farnham,
Surrey GU9 7DR, United Kingdom;
"Resolutions" the resolutions to be proposed at the General
Meeting, as set out in the Notice of General Meeting;
"SEC" the United States Securities and Exchange Commission;
"Shareholder(s)" holder(s) of Ordinary Shares;
"subsidiary undertakings" has the meaning as set out in section
1162 of the Companies Act 2006;
"UK" or "United Kingdom" the United Kingdom of Great Britain and Northern Ireland;
"uncertificated" or "in a share or security recorded in the
Company's register of members
uncertificated form" as being held in uncertificated form, title
to which may be transferred by means of CREST; and
"US" or "United States" the United States of America.
GLOSSARY OF TECHNICAL TERMS
"ABSSSI" acute bacterial skin and skin structure infections;
"clinical development" human testing (healthy volunteers and
patients) of pharmaceutical products;
"CRO" clinical research organisation;
"cSSSI" complicated skin and skin structure infections;
"EMA" European Medicines Agency;
"FDA" the US Food and Drug Administration;
"GAIN Act" the US Generating Antibiotic Incentives Now Act
(which was signed into law on 9 July 2012) which mandates faster
review times at the FDA and grants new antibiotics 5 additional
years of market exclusivity from the date of approval in the US
resulting in a total of 10 years exclusivity;
"Gram-positive bacteria" a class of bacteria with a thick
peptidoglycan layer but no outer membrane. These bacteria take up
the crystal violet stain used in the Gram staining method of
bacterial differentiation. Staphylococcus and Streptococcus are
examples of Gram-positive bacteria;
"Gram-negative bacteria" a class of bacteria with a thin
peptidoglycan layer in their cell wall which is sandwiched between
an inner cell membrane and a bacterial outer membrane. These
bacteria do not retain the crystal violet stain used in the Gram
staining method. Examples are E. coli, Salmonella and
Pseudomonas;
"HABP" hospital acquired bacterial pneumonia;
"INSPIRE" Iclaprim for NoSocomial PneumonIa gRam positive
pathogEns;
"IV" intravenous;
"MAA" Marketing Authorisation Application;
"MEB" Medicines Evaluation Board in The Netherlands;
"mechanism" the way a medicine works;
"MRSA" methicillin-resistant Staphylococcus aureus, a type of
bacterial infection that is resistant to a number of widely used
antibiotics;
"nephrotoxic" harmful to the kidneys;
"NDA" New Drug Application;
"Phase I study" first stage of clinical testing in healthy
volunteers;
"Phase II study" clinical trials in a small number of patients
(usually 20-30) to determine safety and efficacy of a new
medicine;
"Phase III study" the final stage of clinical trials prior to
seeking regulatory approval, to determine efficacy and safety in a
large number of patients (usually several hundred in total);
"preclinical stage programme" laboratory and animal testing
prior to being allowed to test the product in humans;
"QIDP" Qualified Infectious Disease Product;
"REVIVE" Randomized Evaluation intraVenous Iclaprim Vancomycin
treatment; and
"VABP" ventilator associated bacterial pneumonia.
UNAUDITED FIANCIAL INFORMATION OF THE GROUP FOR THE THREE MONTHS
TO 31 MARCH 2016
(extracted from the Form F-1)
Motif Bio plc
Unaudited interim condensed consolidated statements of loss and
comprehensive loss for the three months ended March 31, 2016 and
2015
Three months
ended
March 31,
-----------------------
Note 2016 2015
----------- ----------
U.S. U.S.
$ $
(Unaudited)
Operations
General and administrative expenses 3 (783,477) (319,785)
Research and development expenses 3 (5,792,683) (126,371)
Gains on settlement of contract
disputes 83,320 -
----------- ----------
Operating Loss (6,492,840) (446,156)
Interest income 4 22,438 153
Interest expense 4 (62,909) (119,576)
Net foreign exchange gains/(losses) (11,996) 968
----------- ----------
Loss before income taxes (6,545,307) (564,611)
Income tax 5 - -
----------- ----------
Net loss for the period (6,545,307) (564,611)
----------- ----------
Total comprehensive loss for the
period (6,545,307) (564,611)
=========== ==========
Loss per share for loss from operations
attributable to the
ordinary equity holders of the
company 6
Basic and diluted loss per share US$ (0.06) US$ (0.02)
----------- ----------
The notes are an integral part of these unaudited interim
condensed consolidated financial statements.
Motif Bio plc
Unaudited interim condensed consolidated statements of financial
position at March 31, 2016 and December 31, 2015
At March At December
31, 31,
============ ============
Note 2016 2015
============ ============
U.S. U.S.
$ $
(Unaudited)
ASSETS
Non-current assets
Intangible assets 6,195,748 6,195,748
============ ============
Total non-current assets 6,195,748 6,195,748
============ ============
Current assets
Prepaid expenses and other receivables 7 108,962 167,657
Cash 25,046,218 28,594,347
============ ============
Total current assets 25,155,180 28,762,004
============ ============
Total assets 31,350,928 34,957,752
============ ============
LIABILITIES
Non-current liabilities
Payable on completion of clinical
trial 500,000 500,000
============ ============
Total non-current liabilities 500,000 500,000
============ ============
Current liabilities
Trade and other payables 8 3,859,778 987,083
Other interest-bearing loans and
borrowings 9 3,810,100 3,747,961
============ ============
Total current liabilities 7,669,878 4,735,044
============ ============
Total liabilities 8,169,878 5,235,044
============ ============
Net assets 23,181,050 29,722,708
============ ============
EQUITY
Share capital 10 1,645,291 1,645,291
Share premium 10 38,534,280 38,534,280
Group reorganization reserve 10 9,938,362 9,938,362
Accumulated deficit 10 (26,936,883) (20,395,225)
============ ============
Total equity 23,181,050 29,722,708
============ ============
The notes are an integral part of these unaudited interim
condensed consolidated financial statements
Motif Bio plc
Unaudited interim condensed consolidated statements of changes
in equity for the three months ended March 31, 2016 and 2015
Group
Share Share reorganization Accumulated
capital premium reserve deficit Total
------------- ------------ --------------- -------------- ------------
US $ US $ US $ US $
(Unaudited) US $
Balance at December
31, 2014 1,110 3,964,455 - (14,884,023) (10,918,458)
Loss for the period - - - (564,611) (564,611)
------------- ------------ --------------- -------------- ------------
Total comprehensive
loss for the
period - - - (564,611) (564,611)
Share-based payments - - - 3,175 3,175
------------- ------------ --------------- -------------- ------------
Balance at March
31, 2015 1,110 3,964,455 - (15,445,459) (11,479,894)
------------- ------------ --------------- -------------- ------------
Balance at 31 December
2015 1,645,291 38,534,280 9,938,362 (20,395,225) 29,722,708
------------- ------------ --------------- -------------- ------------
Loss for the period - - - (6,545,307) (6,545,307)
------------- ------------ --------------- -------------- ------------
Total comprehensive
loss for
the period (6,545,307) (6,545,307)
Share-based payments - - - 3,649 3,649
------------- ------------ --------------- -------------- ------------
Balance at March
31, 2016 1,645,291 38,534,280 9,938,362 (26,936,883) 23,181,050
============= ============ =============== ============== ============
The notes are an integral part of these unaudited interim
condensed consolidated financial statements.
Motif Bio plc
Unaudited interim condensed consolidated statements
of cash flows for the three months ended March 31, 2016 and
2015
Three months
ended
March, 31
2016 2015
------------ ---------
U.S. U.S.
$ $
------------ ---------
(Unaudited)
Operating activities
Operating loss for the period (6,492,840) (446,156)
Adjustments to reconcile net loss to
net cash used in activities:
Share-based payments 3,649 3,174
Gains on settlement of contract disputes (83,320) -
Interest received 22,438 153
Changes in operating assets and liabilities:
Prepaid expenses, notes receivable,
and accounts receivable 58,695 (32,209)
Accounts payable and other accrued
liabilities 2,956,015 (104,586)
------------ -----------
Net cash used in operating activities (3,535,363) (579,624)
Financing activities
Proceeds from issuance of promissory
notes - 704,210
Interest paid (770) -
------------ -----------
Net cash provided by financing activities (770) 704,210
Net change in cash (3,536,133) 124,586
Cash beginning of the period 28,594,347 3,281
Effect of foreign exchange rate changes (11,996) 968
------------ -----------
Cash, end of the period 25,046,218 128,835
------------ -----------
The notes are an integral part of these unaudited interim
condensed consolidated financial statements
Management Discussion & Analysis
General And Administrative Expenses
The following table summarizes our general and administrative
expenses during the three months ended March 31, 2016 and 2015:
For the three
months ended,
------------------------------
2016 2015 Change
----- --------------- ------
(in thousands)
Employee benefits expenses 184 45 139
Directors' fees 106 - 106
Advisory fees 30 60 (30)
Legal and professional fees 372 165 208
Other expenses 91 50 41
----- --------------- ------
Total general and administrative
expenses 783 320 463
----- --------------- ------
General and administrative expenses increased by $0.5 million,
or 145%, to $0.8 million in the three months ended March 31, 2016
from $ 0.3 million in the three months ended March 31, 2015. This
increase was primarily attributable to (i) an increase in personnel
related expenses; (ii) the costs associated with being a public
company in the United Kingdom; and (iii) increases in the costs of
outside professional services, including commercial evaluation and
strategy services, investor relations, and other consulting
services.
Research And Development Expense
Research and development expenses increased by $5.7 million to
$5.8 million in the three months ended March 31, 2016 from $0.1
million in three months ended March 31, 2015. This increase was
primarily attributable to the commencement of iclaprim clinical
development. For the three months ended March 31, 2016, $4.9
million was spent in relation to contract research organization
expenses, $0.5 million in relation to clinical operations and $0.4
million in relation to chemistry and manufacturing development and
other non-clinical development.
Gain On Settlement Of Contract Disputes
The gain on settlement of contract disputes in the three months
ended March 31, 2016 relates to the settlement of a dispute with a
contractor which was provided for at December 31, 2015.
Other Income (Expense), Net
Interest income and interest payable are recognized in the
income statement as they accrue, using the effective interest
method. Interest income increased to $22,400 following the increase
in cash balances from proceeds raised during 2015. Interest expense
in the three months ended March 31, 2016 decreased by $57,700 to
$62,900 due to a reduction in debt
outstanding.
Taxation
No tax expenses were charged in the three months ended March 31,
2016 and 2015. Management expects that losses on ordinary
activities will continue to be offset by unrecognised tax
losses.
Notes to the Unaudited Financial Information of the Group for
the three months to 31 March 2016
1. General information and basis of preparation
These interim condensed consolidated financial statements at
March 31, 2016 together with the notes thereto (the "Interim
Condensed Consolidated Financial Statements") of Motif Bio Plc (the
"Company" and together with its subsidiaries the "Group") were
approved for issuance by the Board of directors on June 27, 2016,
and have been prepared in accordance with IAS 34- "Interim
financial reporting". The interim condensed consolidated financial
statements do not constitute statutory financial statements. The
audited Motif Bio Plc annual consolidated financial statements for
the preceding year have been filed with Companies House.
The Interim Condensed Consolidated Financial Statements should
be read in conjunction with the Motif Bio Plc annual consolidated
financial statements for the years ended December 31, 2015 and
2014, which have been prepared in conformity with International
Financial Reporting Standards as issued by the International
Accounting Standards Board and in conformity with International
Financial Reporting Standards as adopted by the European Union
("IFRS").
On April 1, 2015 Motif Bio Limited was re-registered as a public
company limited by shares and changed its name to Motif Bio Plc. On
the same date, Motif BioSciences Inc. became a wholly-owned
subsidiary of the Company by way of a group reorganization by plan
of merger. Therefore, Motif Bio Sciences Inc. is considered to be
the predecessor of the Company prior to the reorganization.
The preparation of financial statements in conformity with IFRS
requires the use of estimates and assumptions that affect the
reported amounts of assets and liabilities at the date of the
financial information and the reported amounts of revenue and
expenses during the period. Although these estimates are based on
management's best knowledge of the amount, event or actions, actual
results ultimately may differ from those estimates. Reference
should be made to the section "Critical accounting estimates and
judgements" in the Annual Consolidated Financial Statements for the
years ended December 31, 2015 and 2014, for a detailed description
of the more significant valuation procedures used by the Group.
The chief operating decision-maker is considered to be the Board
of Directors of Motif Bio plc. The chief operating decision maker
allocates resources and assesses performance of the business and
other activities at the operating segment level. In addition, they
review the interim condensed consolidated financial statements.
The chief operating decision-maker has determined that the Group
has one operating segment-the development and commercialization of
pharmaceutical formulations. All activities take place in the
United States.
2. New standards and amendments
a. New standards and amendments effective from January 1, 2016
There are no new standards and amendments that have been applied
from January 1, 2016, which have had an impact on the Group's
financial statements.
b. New standards and amendments not yet effective
Certain new accounting standards and interpretations have been
published that are not mandatory for the reporting periods covered
by these unaudited interim condensed consolidated financial
statements and have not been early adopted by the Group. The
Group's assessment of the impact of these new standards and
interpretations is set out below.
The expected effective date of IFRS 9- "Financial Instruments"
and IFRS 15- "Revenue from Contracts with Customers" is January 1,
2018 and for IFRS 16- "Leases", is January 1, 2019.
2. New standards and amendments (Continued)
Management has not yet assessed the potential impact of these
new standards. These changes could have a substantial impact on the
Group's financial statements in the coming years.
3. Breakdown of expenses by nature
Three months
ended March
31,
----------------------
2016 2015
------------ --------
U.S. U.S.
$ $
General and administrative expenses
Employee benefits expenses 184,105 45,000
Directors' fees 106,597 -
Advisory fees 30,000 60,000
Legal and professional fees 371,752 164,489
Other expenses 91,023 50,296
============ ========
783,477 319,785
============ ========
Research and development costs 5,792,683 126,371
Gains on settlement of contract
disputes (83,320) -
============ ========
The increase in research and development cost was primarily
attributed to the commencement of iclaprim clinical development in
2016.
Gains on settlement of contract disputes relates to the
settlement of a dispute with a contractor in the first quarter of
2016.
4. Finance income and costs
Three months
ended
March 31,
========================
2016 2015
=========== ===========
U.S. U.S.
$ $
Finance income
Interest from financial assets 22,438 153
=========== ===========
22,438 153
=========== ===========
Finance costs
Interest paid/payable for financial
liabilities (62,909) (119,576)
=========== ===========
(62,909) (119,576)
=========== ===========
Interest income and interest payable are recognized in the
income statement as they accrue, using the effective interest
method. Interest expense in the three months ended March 31, 2016
decreased due to a reduction in debt outstanding. Interest income
in the three months ended March 31, 2016 increased due to an
increase in cash balances.
5. Income tax expense
Income tax expense is recognized based on management's estimate
of the annual income tax expected for the period. Management
expects that losses on ordinary activities will continue to be
offset by unrecognized tax losses.
6. Loss per share
Basic loss per share is calculated by dividing the loss
attributable to equity holders of the Company by the weighted
average number of shares in issue during the period. In accordance
with IAS 33, where the Group has reported a loss for the period,
the shares are anti-dilutive.
Three months
ended
March 31,
=======================
2016 2015
=========== ==========
U.S. U.S.
$ $
Loss after taxation (6,545,307) (564,611)
Basic and diluted weighted
average shares in issue 108,601,496 36,726,342
=========== ==========
Basic and diluted loss per
share (0.06) (0.02)
=========== ==========
The following potentially dilutive securities outstanding at
March 31, 2016 and 2015 have been excluded from the computation of
diluted weighted average shares outstanding, as they would be
antidilutive.
At March 31,
2016 2015
========== ====
Convertible promissory notes 14,510,770 -
Warrants 5,980,822 -
Share options 7,160,803 -
========== ====
27,652,395 -
========== ====
7. Prepaid expenses and other receivables
At March At December
31, 2016 31, 2015
============== ===========
U.S. $ U.S. $
Other receivables and 108,962 167,657
prepayments
8. Trade and other payables
At March At December
31, 2016 31, 2015
=============== ================
U.S. $ U.S. $
Trade payables 3,515,767 108,247
Accrued expenses 343,990 877,238
Amounts due to shareholders 21 1,598
=============== ================
3,859,778 987,083
=============== ================
From December 31, 2015 to March 31, 2016, trade payables
increased by $3.4 million, principally as a
result of an increase in the amounts due to a contract research
organization.
8. Trade and other payables (Continued)
Amounts due to shareholders in respect of accrued interest on
loan notes (see note 11) and other liabilities as follows:
At March At December
31, 2016 31, 2015
=============== ===============
U.S. $ U.S. $
Amounts due to Amphion
Innovations plc
Amounts due to Amphion 104,164 78,409
Innovations
US, Inc. 147,153 110,769
=============== ===============
251,317 189,178
=============== ===============
The amounts due to Amphion increased due to the accrual of
interest at a rate of 7% for 90 days.
9. Other interest bearing loans and borrowings
At March At December
31, 2016 31, 2015
=============== ================
U.S. $ U.S. $
Notes payable to shareholders 3,550,786 3,550,786
Accrued interest expense 259,314 197,175
=============== ================
3,810,100 3,747,961
=============== ================
10. Share capital
Allotted, called up, and fully paid: Number US $
In issue at December 31, 2015 108,601,496 1,645,291
In issue at March 31, 2016 108,601,496 1,645,291
Share premium represents the excess over nominal value of the
fair value consideration received for equity shares
net of expenses of the share issue.
Retained deficit represents accumulated losses.
The group reorganization reserve arose when Motif Bio plc became
the parent of the Group. The transaction, falling as it does
outside the scope of IFRS 3, has been accounted for as a group
reorganization and not a business combination. The reorganization
reserve can be derived by calculating the difference between the
nominal value of the shares in Motif Bio plc issued to the former
shareholders in Motif BioSciences Inc. and the share capital and
share premium of Motif BioSciences Inc. at the date of the
merger.
11. Related party transactions
Transactions with Amphion Innovations plc and Amphion
Innovations US, Inc.
At March 31, 2016 Amphion Innovations plc owned 26.08% of the
issued ordinary shares in Motif Bio plc. In addition, the Amphion
Group has provided funding for the activities of Motif BioSciences
Inc. through the issue of convertible interest bearing loan notes.
Richard Morgan and
11. Related party transactions (Continued)
Robert Bertoldi were directors of both the Company and Amphion
Innovations plc in the period. Transactions between the Group and
the Amphion Group are disclosed below:
At March At December
31, 2016 31, 2015
================ ===================
U.S. $ U.S. $
Amounts due to Amphion
Innovations
US, Inc. . . . . . .
. . . . . . . . . . .
. . . . . . . . . . 21 1,599
Notes payable to Amphion
Innovations plc . . .
. Notes payable to Amphion
Innovations
US, Inc. . . . . . . 1,471,700 1,471,700
. . . . . . . . . . .
. . . . . . . . . . 2,079,086 2,079,086
Three months
ended
March 31,
==================
2016 2015
======= =========
U.S. U.S.
$ $
Accrued and unpaid interest
on loan notes . . . . . . .
. . . . . . . 251,317 1,798,910
Interest expense . . . . . .
. . . . . . . . . . . . . .
. . . . . . . . . . . . . 62,139 108,367
12. Post balance sheet events
In April 2016, Jonathan Gold, a non-executive director, entered
into a consulting agreement with Motif BioSciences Inc.
In April 2016, Pete A. Meyers and Rajesh B. Shukla were
appointed as Chief Financial Officer and Vice President Clinical
Operations, respectively.
In April 2016, the Company granted 2,961,577 options to purchase
ordinary shares to Pete A. Meyers which vest over a four-year
period and are partially based on meeting certain performance
targets. The Company granted 300,000 options to purchase ordinary
shares to Rajesh B. Shukla which vest over a four-year period. The
options have an exercise price of 40.50 pence per ordinary
share.
On April 28, 2016, the Company announced that Amphion had
pledged 14,906,145 ordinary shares of 1 pence each in the capital
of the Company as security to a draw-down of an additional tranche
of Amphion's loan facility.
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCAKNDQBBKKAOD
(END) Dow Jones Newswires
July 13, 2016 02:01 ET (06:01 GMT)
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