TIDMMTFB
RNS Number : 7135V
Motif Bio PLC
20 April 2016
20 April 2016
Motif Bio plc
("Motif" or the "Company")
Final Results for the year ended 31 December 2015
Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical
company specialising in developing novel antibiotics, announces its
maiden full year audited financial results as an AIM-listed
company.
Corporate/operational highlights:
-- AIM listing raising GBP2.8 million (before expenses) at 20 pence per share on 2 April 2015;
-- The U.S. Food and Drug Administration (FDA) agreed to Phase III trials of iclaprim;
-- QIDP designation granted by the FDA for iclaprim in ABSSSI and HABP in July 2015;
-- Independent tests by JMI Laboratories showed iclaprim to be
effective in vitro against a range of Gram-positive bacteria and 16
times more potent than trimethoprim; and
-- Motif contracted with Covance, a global leading CRO for Phase
III clinical trials of iclaprim
Financial Highlights:
-- Successful placing on 22 July 2015 raising GBP22 million
(before expenses) at 50 pence per share;
-- Cash and cash equivalents as at 31 December 2015 of US $28.6 million (31 December 2014: nil)
Since Period End:
-- Began dosing the first patient in the Phase III iclaprim trials in March 2016;
-- Named MTS Health Partners as U.S. Corporate Financial Advisor;
-- Appointed The Fulford Group Ltd. as specialist advisor; and
-- Appointed Pete A. Meyers as CFO, Rajesh B. Shukla as Vice
President Clinical Operations, and named Jon Gold as strategic
financial consultant
The Annual Report will be posted to shareholders and made
available on the Company's website www.motifbio.com by 30 April
2016 and will contain a notice of the Company's forthcoming Annual
General Meeting which will be held in London on 2 June 2016.
Graham Lumsden, CEO of Motif Bio plc said: "2015 was a
transformational year for Motif Bio, with admission to AIM in
April, securing capital of GBP23 million (net of expenses) through
two equity fundraisings, and achieving a number of key milestones
that provides the Company with a platform for further progress in
2016.
Motif Bio is now well-positioned as an antibiotic development
company with a lead compound, iclaprim, in Phase III clinical
trials targeting serious and life threatening infections and with
commercialisation anticipated for 2018. We are in the rare position
of already having data from more than 500 patients establishing
safety and efficacy of iclaprim, including activity against
multi-drug resistant bacteria such as MRSA."
For further information please contact:
Motif Bio plc info@motifbio.com
Graham Lumsden (Chief
Executive Officer)
David Huang (Chief Medical
Officer)
Zeus Capital Limited (NOMAD
& BROKER)
Phil Walker/Dan Bate
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
Chairman's Statement
All successful pharmaceutical companies depend, in the first
place, on addressing an unmet medical need with a new or a better
therapy. It is quite clear that the onset of multidrug resistance
in the current families of antibiotics is creating a looming crisis
in healthcare. Almost all modern medical procedures depend on the
availability of effective antibiotics. It is gratifying that
governments and regulators are now taking steps to encourage the
development of novel antibiotics to address this growing medical
emergency.
Motif's lead compound, iclaprim, is just such an antibiotic,
with an underutilised mechanism of action targeted at killing
bacteria rather than limiting growth. While a good molecule and an
unmet medical need are necessary, they are not the only factors
required for success. In Motif's case, iclaprim has an established
safety and efficacy profile based on previous trials but it is
still necessary for an emerging specialty pharma company like Motif
to be able to access the capital markets to fund the additional
development programmes and clinical tests required by regulators
such as the U.S. Food and Drug Administration (FDA) and the
European Medicines Agency (EMA). Success further depends on the
skill and hard work of the team to execute well on the clinical
development programmes and to support a compelling
pharmaco-economic proposition to target customers which, in the
case of iclaprim, are the hospital formularies. Even a good
molecule will not fulfill its potential if it is not backed up by
high quality data supporting its therapeutic value. Motif is in the
unusual position of being able to access a huge amount of data
accumulated in the earlier clinical development of iclaprim and
this has defined the design and administration of the additional
trials required by the regulators.
Over the last year, Motif has managed to complete the
acquisition of the iclaprim assets, list on the AIM market via a
successful IPO raising GBP2.8 million, conclude a satisfactory
review meeting with the FDA, raise an additional GBP22 million from
blue chip institutional investors, receive Qualified Infectious
Disease Product (QIDP) designation from the FDA and, most important
of all, design and initiate the Phase III clinical trials that the
regulatory agencies want to see completed before they will grant
marketing approval. Providing Motif can successfully raise
additional development capital these new Phase III trials are
expected to be completed within 18 months and, if all goes well,
Motif should have an application submitted to the FDA by the end of
2017.
In parallel, over the last year Motif has made progress in
building the leadership team and has added specialist advisory
groups to assist in two key areas. Motif has recently appointed Mr.
Pete Meyers as Chief Financial Officer and Dr. Rajesh Shukla as
Vice President Clinical Operations. I would like to welcome them
both to the Motif team and I would like to thank Robert Bertoldi
for his invaluable contribution as CFO through the AIM listing and
since. In addition, we now have one firm helping the Company to
explore strategic financing options including the possibility of a
listing on the NASDAQ stock market in the US. And a second firm is
actively soliciting interest in the potential of a partnership for
the distribution of iclaprim outside the United States. There is
still a lot to do and your board and management team are committed
to maintaining an intense focus on good execution. We look forward
to the opportunity to report further progress towards bringing this
important new therapy to patients in hospitals around the world who
are facing the need to deal with increasingly resistant and, in
some cases, potentially life threatening infections.
Richard C.E. Morgan
Chairman
20 April 2016
Chief Executive Officer's Statement
2015 was a transformational year for Motif Bio, with admission
to AIM in April, securing capital of GBP23 million (net of
expenses) through two equity fundraisings, and achieving a number
of key milestones that provide the Company with a platform for
further progress in 2016.
Motif Bio is now well-positioned as an antibiotic development
company with a lead compound, iclaprim, in Phase III clinical
trials targeting serious and life threatening infections and with
commercialisation anticipated for 2018. We are in the rare position
of already having data in more than 500 patients establishing the
safety and efficacy of iclaprim, including activity against
multi-drug resistant bacteria such as MRSA.
Iclaprim - a novel antibiotic targeting multi-drug resistant
bacteria that cause serious and life-threatening infections
Through our merger with Nuprim Inc., which closed in April upon
admission to AIM, we acquired the exclusive worldwide rights to
develop and commercialise iclaprim, a novel antibiotic that targets
the multi-drug resistant Gram-positive bacteria that cause serious
and life-threatening hospital acquired infections.
Iclaprim kills bacteria using an underutilised mechanism of
action (dihydrofolate reductase inhibition), meaning that iclaprim
can kill bacteria that have developed resistance to other
antibiotics that work by different mechanisms. Iclaprim has
completed a comprehensive development programme demonstrating
safety and efficacy in more than 500 patients with complicated skin
and skin structure infections. In 2009, the previous developer of
iclaprim received a "Complete Response Letter" from the US Food and
Drug Administration (FDA) requesting an additional study to
demonstrate effectiveness. The European Marketing Authorisation
Approval was then withdrawn. Iclaprim was one of four antibiotics
that did not gain approval around this time, shortly after another
newly approved antibiotic had been found to be associated with
severe liver injury and fraudulent safety data, negatively
impacting the regulatory environment. The regulatory environment
has subsequently become more favourable, with approval in 2014 of
two of the other antibiotics that had similar requests for
additional data. The Generating Antibiotic Incentives Now Act (the
GAIN Act) was passed as a new law in the United States in 2012,
providing several incentives for new antibiotics, including
extended market exclusivity, accelerated review of the application
for regulatory approval, and fast track submission of data. The
previous successful development programme has meant that we were
able to learn from the existing data and make several key
improvements for
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our Phase III trials.
To have a much-needed antibiotic so close to approval and
commercialisation presents a significant opportunity for the
Company and our shareholders.
Iclaprim - an attractive target market
Resistance to antibiotics is a major global health threat, with
so-called "superbugs" developing resistance more quickly than new
effective antibiotics are being developed. Iclaprim will initially
focus on two serious and life-threatening infections.
The first is Acute Bacterial Skin and Skin Structure Infections
(ABSSSI), a common serious infectious disease often caused by
multi-drug resistant bacteria, such as MRSA. Around 2.3 million
patients in the US are affected by ABSSSI every year. Our first
Phase III trials, currently underway, are in patients with
ABSSSI.
The second is for Hospital Acquired Bacterial Pneumonia (HABP),
one of the most common hospital acquired infections in the
intensive care setting, estimated to affect 1.1 million patients in
the US annually with a mortality rate of between 20% to 50%
depending on how quickly and effectively it is treated. Phase II
trials have already demonstrated the efficacy of iclaprim for
patients with HABP and we expect to start trials for this
indication in the second half of 2016. This trial is likely to take
three years to complete.
Providing we can raise sufficient additional development
capital, our current Phase III trials for ABSSSI are expected to
conclude in 2017, and if approved iclaprim will be particularly
suitable for patients with ABSSSI who also suffer from renal
impairment or kidney disease. The current standard of care for
treating ABSSSI is vancomycin. However, around 26% of high-risk
hospitalised ABSSSI patients suffer from kidney disease and
vancomycin is well known to be nephrotoxic (kidney damaging) and
requires dose adjustment depending on the severity of kidney
disease, therefore vancomycin is not a good option. Iclaprim is not
nephrotoxic and requires no dosage adjustment, offering an
appropriate alternative in these patients.
2015 - a transformational year
As part of our listing on AIM in April 2015, we raised
approximately GBP2.5 million in net funds and concluded a further
placing in July 2015 raising GBP20.75 million in net funds. This
provided us with the funding needed to complete the preparations
and start the Phase III trials that began with the first patient
dosed in March 2016.
Our clinical trials are being run by Covance, our CRO. The two
trials are global, multicentre, randomised, double-blind studies
evaluating a total of 1,200 adult patients hospitalised with
ABSSSI. Covance has considerable experience running antibiotic
trials and we are confident that they are the best CRO for our
programme which includes 160 clinical trial sites across the US,
Europe, and Latin America.
The primary endpoint for the studies will be at least a 20%
reduction in lesion size at 48 to 72 hours after initiation of
antibiotic treatment. The key secondary endpoint is clinical cure
at one to two weeks after antibiotic treatment ends. The successful
completion of these two pivotal Phase III trials would satisfy both
FDA and EMA requirements for regulatory approval.
Iclaprim has been designated as a Qualified Infectious Disease
Product (QIDP) for the treatment of ABSSSI and HABP. The QIDP
designation will make iclaprim eligible to benefit from certain
incentives as provided under the GAIN Act. These incentives include
FDA priority review, eligibility for fast-track status, and if
ultimately approved by the FDA, iclaprim would be eligible for an
additional five-year extension of Hatch-Waxman exclusivity, for a
total of 10 years of market exclusivity, starting from the date of
New Drug Application (NDA) approval.
Additional supportive clinical data
Two important posters were accepted and presented at ID Week in
San Diego, CA in October 2015. One summarised the Phase II data
from trials in patients with Hospital Acquired Bacterial Pneumonia
where iclaprim demonstrated safety and efficacy. The second poster
described the efficacy of iclaprim at 72 hours after starting
treatment in the prior Phase III complicated Skin and Skin
Structure trials. Iclaprim was compared with another antibiotic,
linezolid, and was shown to effectively halt the spread of skin
lesions at 72 hours. This was important to show because in the
current Phase III trials, the efficacy of iclaprim is being judged
by measuring the size of the skin lesions at 48 to 72 hours after
initiating treatment.
In addition, we announced in August 2015 that topline results of
a laboratory study confirmed that iclaprim is active and highly
potent against target bacteria, including Staphylococcus aureus,
collected between 2012 and 2014 from patients around the world with
serious, life-threatening hospital infections.
2016 - the year ahead
The main achievement for 2016 so far has been the commencement
of our first Phase III studies and the first dosing of patients. In
addition, in the first quarter of 2016 we also announced the
appointment of two strategic advisers, which herald two
developments in the Company's progress that we believe will help us
to deliver significant value to shareholders.
In January 2016, we appointed US healthcare investment bank MTS
Health Partners (MTS) to advise on potential future financing
options within the US market. A NASDAQ listing continues to be an
option for us. Not only would it open up additional avenues of
funding but it would also help to align us with a number of our US
listed peer companies. Initial feedback has been positive from an
investor audience that is well versed in the pharmaceutical
development space and recognises the advantageous position that we
are currently in with a candidate at such an advanced stage and
with the unusual position of having a safety database comprised of
500 patients already treated with iclaprim.
In March, we appointed Fulford Group Ltd. as a specialist
adviser to identify the most appropriate strategic partner(s) for
the commercialisation of iclaprim in geographies outside of the US.
We intend to commercialise iclaprim in the US ourselves. Whether
these partners are large companies spanning multiple geographies or
individual partners for specific regions, such deals can provide
the Company with additional development capital in the form of
upfront payments, milestone payments, and ongoing royalty fees. We
expect to be able to update shareholders on progress in this area
over the course of 2016.
We also expect to be able to provide updates to our Phase III
programme for our second indication, HABP, which we expect to begin
in the second half of 2016.
We anticipate making progress with our oral formulation
development programme for iclaprim. This has advantages when
treating bone or joint infections, which often require a longer
period of treatment (six weeks or more). In addition, we plan to
seek additional antibiotic assets and if possible we intend to
acquire such assets through in-licensing arrangements that should
build incremental value for shareholders.
In recent weeks, we appointed Pete A. Meyers as Chief Financial
Officer and Rajesh B. Shukla, Ph.D. as Vice President Clinical
Operations. Pete's experience in capital markets, M&A, and
financial operations combined with Rajesh's depth of knowledge in
clinical operations will ensure strong leadership in these critical
functions. I am pleased to welcome them both to the Motif team.
I would like to offer my thanks to our shareholders for their
continued support and to my colleagues who continue to work with me
to build value for our shareholders.
Graham Lumsden
Chief Executive Officer
20 April 2016
Strategic Report
Strategy and Business Model
The Group's business strategy is to develop novel antibiotics
that are designed to be effective against serious and
life-threatening infections caused by multi-drug resistant
bacteria. With an initial focus on hospital infections (rather than
infections handled by office-based physicians), the intention is,
to commercialise directly in the United States and to partner with
other companies for commercialisation in other countries. The
Company expects to generate revenues from sales of its
pharmaceutical products, once they are approved. In addition, the
Company expects to be able to enter into distribution and marketing
agreements in one or more territories outside the US, which could
result in cash payments from partners in the form of upfront
payments, progress-based milestone payments, and royalties on
sales. This strategy is expected to result in continuing losses
until revenues from these sources exceed operating costs, including
investment in R&D and marketing expenses. The Board expects to
be able to support its discovery and development plans for the
foreseeable future and to raise sufficient capital to be able to
launch and sell its products in the United States.
The Company's lead product candidate, iclaprim, is being
developed for the treatment of the most common and serious
bacterial infections such as acute bacterial skin and skin
structure infections (ABSSSI) and hospital acquired bacterial
pneumonia (HABP), including those caused by resistant strains such
as MRSA (methicillin-resistant Staphylococcus aureus). Two pivotal
Phase III ABSSSI clinical trials, designed to meet regulatory
requirements for approval in the United States and Europe, are on
track to be completed in 2017 and if approved, iclaprim could be
ready for commercialisation in 2018. A Phase III clinical trial to
determine the efficacy of iclaprim in HABP is planned to start in
2016.
In addition, the Company is in discussions with pharmaceutical
companies and universities to build a pipeline of innovative
antibiotics targeting Gram-positive and Gram-negative bacteria.
Principle Risks and Uncertainties
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The principle risks faced by the Group, and the actions taken to
mitigate them, are shown in the table below:
Risk Description Principle mitigation
-------------- ----------------------------- --------------------------------
Intellectual In common with other The Group actively manages
property companies engaged its intellectual property
in pharmaceutical (IP), engaging with
development, the specialists to apply
Group faces the for and defend IP rights
risk that intellectual in appropriate territories.
property rights As the Group has no
necessary to exploit iclaprim patents, it
its research and will depend on the already
development efforts granted QIDP (Qualified
may not be adequately Infectious Disease Product)
secured or defended. designation under the
The Group's intellectual GAIN (Generating Antibiotic
property may also Incentives Now) Act
become obsolete, to provide market exclusivity
preventing commercial within the US. Outside
exploitation. the US, the Group will
depend on similar provisions
from regulatory agencies
in different territories
and on the distribution
partners it is able
to attract.
-------------- ----------------------------- --------------------------------
Research and The Group may not The lead product candidate,
Development generate further iclaprim, has successfully
attractive drug completed a comprehensive
candidates and candidates preclinical and clinical
already in development development programme
may fail preclinical and the safety and efficacy
testing or clinical profile is well understood.
trials because of The Phase III trials
lack of efficacy, that are underway have
unacceptable side been designed based
effects, or insurmountable on the data from the
challenges in conducting development programme
studies adequate completed to date.
to support regulatory
approvals. Practical
issues, such as
inability to devise
acceptable formulations
for products or
inability to manufacture
products at acceptable
cost, may also lead
to failure of candidates
in development.
-------------- ----------------------------- --------------------------------
Regulatory Drug development The Group's drug development
is a highly regulated team includes specialists
activity governed in regulatory affairs
by different regulatory who consult with other
authorities in different experts to ensure that
jurisdictions. It internal control processes
can be difficult and clinical trial design
to predict the exact meet current regulatory
requirements of requirements. The Group
different regulatory also engages directly
bodies. Decisions with regulatory authorities
by regulators may when appropriate.
lead to delays in
development and
approval of drugs
or lack of marketing
authorisations in
some or all territories.
-------------- ----------------------------- --------------------------------
Risk Description Principle mitigation
-------------- ----------------------------- --------------------------------
Commercial The Group may be The Group consults with
and economic unable to effectively commercial, clinical,
commercialise or and scientific experts
license its products to assess the payer
to partners or may and prescriber environment
not be able to execute and the potential impact
licensing deals of competing products
that provide significant or changes in the economic
revenues. Development landscape pertaining
of alternative technologies to hospital infections.
or products may The Group actively monitors
undermine the Group's performance of key competitors
capacity to generate in terms of pricing,
revenue flowing market share, and prescribing
from commercialisation behavior.
of its assets. If
the Group's drugs
are commercialised,
they may not generate
significant revenues
if their use and
sale is restricted
by regulators or
by failure of healthcare
payors to provide
adequate reimbursement
of drug costs.
-------------- ----------------------------- --------------------------------
Financial The successful development The Group has successfully
of the Group's assets engaged with investors
requires financial to generate significant
investment which cash resources which,
can come from revenues, providing we can raise
commercial partners, sufficient additional
or investors. Failure development capital,
to generate additional are considered sufficient
funding from these to fund current plans
sources may compromise for the clinical development
the Group's ability of the Group's lead
to execute its business antibiotic, iclaprim.
plans or to continue The Group operates robust
in business. controls over expenditures
including budgeting
and authorisation of
individual expenditures.
-------------- ----------------------------- --------------------------------
Operational The Group may not The Group's recruitment
be able to recruit processes are tailored
and retain appropriately to identify and attract
qualified staff. the best candidates
Facilities and other for specific roles.
resources may become The Group aims to provide
unavailable. competitive rewards
and incentives to staff
and directors, and informally
benchmarks the level
of benefits provided
to its people against
similar companies.
-------------- ----------------------------- --------------------------------
Business review
The Group's results for the year are set out in the consolidated
income statement on page 19. A review of the Group's performance
during the year, together with its position at the end of the year,
is given in the CEO's Statement on page 2.
Selected peer companies developing antibiotics, including
Allergan, Cempra, Nabriva, Paratek, and Tetraphase, are regularly
followed and studied as benchmarks for clinical development
timelines, product pricing, capital requirements, financial
metrics, and market positioning. Qualitative and quantitative
market research is used to identify and assess market opportunities
for novel antibiotics.
Going concern basis
Information on the Group's business activities and financial
position, together with the factors most likely to affect its
future development, performance, and position, is set out above. In
addition, note 3 to the financial statements includes the Group's
objectives, policies, and processes for managing its capital, its
financial risk management objectives, and its exposure to credit
risk and liquidity risk.
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During the year, the Group met its day-to-day working capital
requirements through cash reserves obtained through fundraising.
The Directors consider that the current position of the Group is
not unusual for a drug discovery and development company.
The Group has prepared detailed financial forecasts extending at
least 12 months from the date of approval. These forecasts assume
no sales and the continuation of costs associated with drug
discovery and development. The forecasts show that the Group should
be able to operate for at least the next 12 months from the date of
these financial statements. The Directors acknowledge that
uncertainty remains over the ability of the Group to have the
resources to fully support the iclaprim trials. However, the
Directors believe the Group will be able to secure financing
through public markets, private financing, and partnering
opportunities. In addition, since the majority of costs are
associated with the clinical trials of iclaprim, the Directors
believe the trials could be, if necessary, slowed or stopped.
Although these measures would have an adverse effect on the
commercialisation of iclaprim, the cost savings would extend the
Group's ability to maintain itself as a going concern.
Approved by the Board and signed on its behalf by:
Richard C.E. Morgan
Chairman
20 April 2016
Motif Bio plc
Consolidated statement
of comprehensive
(loss)/income
For the year ended
31 December 2015
Restated
12 months 12 months
ended ended
31 December 31 December
2015 2014
Note US $ US $
--------------------------- ----- --- ------------------------------ --- -------------------------------------
Operations
General and administrative
expenses 4 (3,577,180) (1,096,116)
Research and development
expenses 4 (4,680,940) -
Operating loss (8,258,120) (1,096,116)
Interest income 4 15,028 78
Interest expense 4 (268,216) (449,036)
Net foreign exchange
gains/(losses) (9,644) -
Other income 4 5,027 360,060
Loss before income
taxes (8,515,925) (1,185,014)
Income tax 7 (774) (876)
Net loss for the year (8,516,699) (1,185,890)
------------------------------ -------------------------------------
Total comprehensive
loss for the year (8,516,699) (1,185,890)
------------------------------ -------------------------------------
Loss per share for loss
from operations 8
attributable to the
ordinary
equity holders of the
company:
Basic and diluted * US $ (0.14) US $ (0.18)
------------------------------ -------------------------------------
* In accordance with IAS33 "Earnings per share", where
the entity has reported a loss for the period, the
shares are not diluted.
The notes are an integral part of these consolidated financial
statements.
Motif Bio plc
Consolidated statement
of financial position
As at 31 December 2015
Restated
31 December 31 December
2015 2014
Note US $ US $
------------------------------- ----- ---------------------------- ---------------------------------
ASSETS
Non-current assets
Intangible assets 9 6,195,748 -
Total non-current assets 6,195,748 -
---------------------------- ---------------------------------
Current assets
Notes receivable - 12,000
Prepaid expenses and other
receivables 10 167,657 210,661
Cash 11 28,594,347 3,281
Total current assets 28,762,004 225,942
---------------------------- ---------------------------------
Total assets 34,957,752 225,942
---------------------------- ---------------------------------
LIABILITIES
Non-current liabilities
Payable on completion
of clinical trial 9 500,000 -
---------------------------- ---------------------------------
Total non-current liabilities 500,000 -
---------------------------- ---------------------------------
Current liabilities
Trade and other payables 12 987,083 2,393,616
Other interest-bearing
loans and borrowings 13 3,747,961 8,750,784
Total current liabilities 4,735,044 11,144,400
---------------------------- ---------------------------------
Total liabilities 5,235,044 11,144,400
---------------------------- ---------------------------------
Net assets/(liabilities) 29,722,708 (10,918,458)
---------------------------- ---------------------------------
EQUITY
Share capital 15 1,645,291 1,110
Share premium 38,534,280 3,964,455
Group reorganisation reserve 15 9,938,362 -
Accumulated deficit (20,395,225) (14,884,023)
Total equity 29,722,708 (10,918,458)
---------------------------- ---------------------------------
The financial statements were approved by the
Board of Directors and authorised for issue on
20 April 2016. They were
signed on its behalf by:
Director
Richard C.E. Morgan
The notes are an integral part of these consolidated financial
statements.
Motif Bio plc
Company statement of financial
position
At 31 December 2015
31 December
2015
Note US $
-------------------------------- ----- ----------------------------
ASSETS
Non-current assets
Investment 18 11,663,308
Total non-current assets 11,663,308
----------------------------
Current assets
Prepaid expenses and other
receivables 10 438,072
Cash 11 28,543,181
Total current assets 28,981,253
----------------------------
Total assets 40,644,561
----------------------------
LIABILITIES
Current liabilities
Trade and other payables 12 57,488
Total current liabilities 57,488
----------------------------
Total liabilities 57,488
----------------------------
Net assets 40,587,073
----------------------------
EQUITY
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Share capital 15 1,645,291
Share premium 38,534,280
Reorganisation reserve 15 (544,378)
Accumulated earnings 951,880
Total equity 40,587,073
----------------------------
The notes are an integral part of these consolidated financial
statements.
Motif Bio plc
Consolidated
statement
of changes in
equity
For the year
ended
31 December
2015
Group
Share Share reorganisation Accumulated
capital premium reserve deficit Total
Note US $ US $ US $ US $ US $
---------------- ----- ------------------ -------------------- -------------------------- ---------------------- ----------------
Balance at 1
January
2014 844 3,692,207 - (13,969,350) (10,276,299)
Loss for the
year - - - (1,185,890) (1,185,890)
------------------ -------------------- -------------------------- ---------------------- ----------------
Total
comprehensive
loss for the
year - - - (1,185,890) (1,185,890)
Issue of share
capital 211 210,373 - - 210,584
Exercise of
share
options 55 61,875 - (28,930) 33,000
Stock based
payments 14 - - - 300,147 300,147
------------------ -------------------- -------------------------- ---------------------- ----------------
Balance at 31
December
2014 1,110 3,964,455 - (14,884,023) (10,918,458)
------------------ -------------------- -------------------------- ---------------------- ----------------
Loss for the
year - - - (8,516,699) (8,516,699)
------------------ -------------------- -------------------------- ---------------------- ----------------
Total
comprehensive
income for the
year - - - (8,516,699) (8,516,699)
Conversion of
promissory
notes 3,573 6,275,213 - - 6,278,786
Group
reorganisation 15 539,267 (10,239,668) 9,938,362 - 237,961
Issue of share
capital 15 1,095,805 41,334,240 - - 42,430,045
Cost of
issuance - (2,898,693) - - (2,898,693)
Exercise of
share
options and
warrants 5,536 98,733 - - 104,269
Issue of
warrants
to acquire
assets 9 - - - 2,340,373 2,340,373
Share-based
payments 14 - - - 665,124 665,124
------------------ -------------------- -------------------------- ---------------------- ----------------
Balance at 31
December
2015 1,645,291 38,534,280 9,938,362 (20,395,225) 29,722,708
------------------ -------------------- -------------------------- ---------------------- ----------------
The notes are an integral part of these consolidated financial
statements.
Motif Bio plc
Company statement of
changes in equity
For the period from 20 November 2014 (date
of incorporation) to 31 December 2015
Share Share Reorganisation Accumulated
capital premium reserve earnings Total
Note US $ US $ US $ US $ US $
---------------- ----- --------------- ------------------- ---------------------------- ----------------------- --------------------
Balance at 20 -
November
2014 - - - -
Loss for the
period - - - (1,757,475) (1,757,475)
--------------- ------------------- ---------------------------- ----------------------- --------------------
Total
comprehensive
loss for the
period - - (1,757,475) (1,757,475)
Group
reorganisation 15 544,378 - (544,378) - -
Issue of share
capital 15 1,095,377 41,334,240 - - 42,429,617
Cost of
issuance - (2,898,693) - - (2,898,693)
Exercise of
share
options and
warrants 5,536 98,733 - - 104,269
Issue of
warrants
to acquire
assets 9 - - - 2,340,373 2,340,373
Share-based
payments 14 - - - 368,982 368,982
--------------- ------------------- ---------------------------- ----------------------- --------------------
Balance at 31
December
2015 1,645,291 38,534,280 (544,378) 951,880 40,587,073
--------------- ------------------- ---------------------------- ----------------------- --------------------
The notes are an integral part of these consolidated financial
statements.
Motif Bio plc
Consolidated statement of cash
flows
For the year ended 31 December
2015
Restated
12 months 12 months
ended ended
31 December 31 December
2015 2014
Note US $ US $
----------------------------------------- ----- ------------------------------- ---------------------------------
Operating activities
Operating loss for the year (8,258,120) (1,096,116)
Adjustments to reconcile net
loss to net cash used in activities:
Share-based payments 14 325,908 300,147
Interest received 15,028 78
Other income 4 5,995 360,060
Taxation paid (774) (876)
Changes in operating assets
and liabilities:
Prepaid expenses, notes receivable,
and accounts receivable (155,578) (222,661)
Accounts payable and other
accrued liabilities 69,857 657,693
------------------------------- ---------------------------------
Net cash used in operating activities (7,997,684) (1,675)
------------------------------- ---------------------------------
Financing activities
Proceeds from issuance of promissory
notes 704,210 210,364
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Proceeds from issue of share
capital 15 38,660,106 210,584
Costs of issuance (2,559,477) -
Proceeds from exercise of options 62,739 33,000
Interest paid (268,216) (449,036)
------------------------------- ---------------------------------
Net cash provided by financing
activities 36,599,362 4,912
------------------------------- ---------------------------------
Net change in cash 28,601,678 3,237
Cash, beginning of the year 3,281 44
Effect of foreign exchange rate
changes (10,612) -
------------------------------- ---------------------------------
Cash, end of the year 28,594,347 3,281
------------------------------- ---------------------------------
Non-cash investment activity
Acquisition of intangible asset
with equity issuances 6,195,748 -
The notes are an integral part of these consolidated financial
statements.
Motif Bio plc
Company statement of cash flows
For the period from 20 November 2014 (date of
incorporation) to 31 December 2015
Period ended
31 December
2015
Note US $
------------------------------------------- ----- -------------------------------
Operating activities
Operating loss for the period (1,761,623)
Adjustments to reconcile net loss
to net cash used in activities:
Share-based payments 14 29,766
Interest received 14,760
Changes in operating assets and
liabilities:
Prepaid expenses, notes receivable,
and accounts receivable (438,072)
Accounts payable and other accrued
liabilities 57,488
-------------------------------
Net cash used in operating activities (2,097,681)
-------------------------------
Investing activities
Capital contributions to subsidiary,
after acquisition (5,511,894)
Net cash used in investing activities (5,511,894)
-------------------------------
Financing activities
Proceeds from issue of share capital 15 38,660,106
Costs of issuance (2,559,477)
Proceeds from exercise of options 62,739
-------------------------------
Net cash provided by financing activities 36,163,368
-------------------------------
Net change in cash 28,553,793
Cash, beginning of the period -
Effect of foreign exchange rate
changes (10,612)
-------------------------------
Cash, end of the period 28,543,181
-------------------------------
The notes are an integral part of these consolidated financial
statements.
Notes to the consolidated financial statements of Motif Bio
plc
For the year ended 31 December 2015
1. General information
Motif Bio Limited ("the Company") was incorporated in England
and Wales on 20 November 2014 with company registration number
09320890. The Company's registered office is at One Tudor Street,
London, EC4Y 0AH, UK. On 1 April 2015 the Company was re-registered
as a public company limited by shares and changed its name to Motif
Bio plc. Motif BioSciences Inc. was incorporated in the US State of
Delaware on 2 December 2003 and has its registered office at 160
Greentree Drive, Suite 101, Dover, Delaware, 19904. On 1 April
2015, Motif BioSciences Inc. became a wholly owned subsidiary of
the Company by way of a group reorganisation by plan of merger. The
principal place of business is 125 Park Avenue, 25(th) Floor, New
York, NY, 10017, USA. The Company's country of domicile is the
UK.
Motif Bio plc 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 consolidated financial
statements include the accounts of Motif Bio plc and its wholly
owned subsidiary, Motif BioSciences Inc. ("the Group").
The financial statements were approved by the Board of Directors
on 20 April 2016.
Significant events
Nuprim merger
On 31 December 2014, Motif BioSciences Inc. entered into the
Nuprim Merger agreement with Nuprim Inc. and the former Nuprim
shareholders pursuant to which Nuprim Inc. would merge with and
into Motif BioSciences Inc., which would be the surviving
corporation. Under the terms of the Nuprim merger procedure Motif
BioSciences Inc. obtained the exclusive worldwide rights to the
assets owned by Nuprim, including the iclaprim assets, and the
rights to acquire certain ancillary materials over a period ending
31 December 2017. Motif BioSciences Inc. issued 1,513,040 (post
reverse stock split) shares of common stock to the shareholders of
Nuprim Inc. that were held in escrow until the closing of the
reorganisation. These shares of common stock in Motif BioSciences
Inc. were converted into ordinary shares in Motif Bio plc upon
admission to the AIM market of the London Stock Exchange on 2 April
2015 (admission). Upon admission, 9,805,400 ordinary shares of
Motif Bio plc and 9,432,033 warrants were issued to the former
Nuprim shareholders (note 9).
Group reorganisation by plan of merger and initial public
offering
On 18 February 2015, Motif Bio Limited incorporated a Delaware
subsidiary, Motif Acquisition Sub, Inc. On 27 March 2015 Motif
BioSciences Inc., Motif Bio Limited, and Motif Acquisition Sub,
Inc. entered into a plan of merger where, upon admission, Motif
Acquisition Sub, Inc. merged with and into Motif BioSciences Inc.
and Motif BioSciences Inc. continued as the surviving entity and
became a wholly owned subsidiary of Motif Bio plc. Prior to the
merger, Motif BioSciences Inc. completed a reverse stock split in
order to increase the share price of Motif BioSciences Inc. so that
it was closer to the Motif Bio plc admission price. The former
Motif BioSciences Inc. shareholders were issued with 36,726,242
ordinary shares in Motif Bio plc in a share-for-share exchange for
their common stock in Motif BioSciences Inc. so that immediately
following the merger the former Motif BioSciences Inc. shareholders
owned an equivalent number of ordinary shares in Motif Bio plc as
the number of shares of common stock that they had previously owned
in Motif BioSciences Inc. All outstanding, unexercised, and vested
stock options over shares of common stock in Motif BioSciences Inc.
were converted into options over ordinary shares in Motif Bio plc
(note 17).
Although the share-for-share exchange resulted in a change of
legal ownership, this was a common control transaction and
therefore outside the scope of IFRS 3. The transaction has
therefore been accounted for as a group reorganisation, and not a
business combination. By applying merger or pooling principles, as
opposed to acquisition accounting, the Group is presented as if
Motif Bio Plc has always owned Motif BioSciences Inc. The
comparatives presented in these financial statements therefore
represent the results and capital structure of Motif Biosciences
Inc. The reserve on consolidation represents the difference between
the nominal value of the shares in Motif Bio plc issued to the
former shareholders of Motif BioSciences Inc. and the share capital
and share premium of Motif BioSciences Inc at the date of the
transaction. As stated, the nominal value of the Motif Bio plc
shares were used in the calculation of the reorganisation reserve.
This is due to the application of merger relief, a relief under
section 612 of the Companies Act 2006, which relieves the
requirement to transfer the difference between the nominal and fair
value of the issued shares to a share premium account.
The consolidated statement of changes in equity on page 22 and
the additional disclosures in note 15 explain the accounting for
the share-for-share exchange in more detail.
2. Significant accounting policies
a. Basis of preparation
On 2 April 2015, the Company was admitted to AIM, a market
operated by the London Stock Exchange, and issued 14,436,140 of its
ordinary shares at a price of GBP0.20 per share.
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On 21 July 2015, the Company had a subsequent placing of
44,000,000 ordinary shares at a price of GBP0.50 per share.
The accounting policies set out below have, unless otherwise
stated, been applied consistently to all periods presented in this
financial information.
The financial statements have been prepared in accordance with
the Companies Act 2006 as applicable to companies under IFRS and
the requirements of the AIM Rules for Companies and in accordance
with this basis of preparation. This basis of preparation describes
how the financial statements have been prepared in accordance with
International Financial Reporting Standards as adopted by the
European Union (IFRSs as adopted by the EU). The financial
statements have been prepared under the historical cost convention.
A summary of the more important company accounting policies is set
out below.
The comparative information for the year ended 31 December 2014
has been extracted from the audited non-statutory financial
statements of Motif BioSciences Inc. for the year then ended. The
auditors' report on these financial statements, from Motif
BioSciences Inc.'s former auditors, was unqualified.
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.
The Group's business activities, together with factors likely to
affect its future development, performance, and financial position
are set out in the Chairman's Statement, the CEO's Statement and
the Strategic Report on pages 2-7.
Going Concern
These consolidated financial statements of the Group are
prepared on a going concern basis taking into account the
successful completion of its admission to AIM on 2 April 2015
generating net proceeds of GBP2.5 million and a subsequent placing
on 21 July 2015 generating net proceeds of GBP20.7 million.
The Directors have prepared cash flow forecasts extending at
least 12 months from the date of approval. These forecasts assume
no sales and the continuation of costs associated with drug
discovery and development. The forecasts show that the Group should
be able to operate for at least the next 12 months from the date of
these financial statements. The Directors acknowledge that
uncertainty remains over the ability of the Group to have the
resources to fully support the iclaprim trials. However, the
Directors believe the Group will be able to secure financing
through public markets, private financing, and partnering
opportunities. In addition, since the majority of costs are
associated with the clinical trials of iclaprim, the Directors
believe the trials could be, if necessary, slowed or stopped.
Although these measures would have an adverse effect on the
commercialisation of iclaprim, the cost savings would extend the
Group's ability to maintain itself as a going concern.
In the event that we do not have adequate capital to maintain or
develop our business, additional capital may not be available to us
on a timely basis, on favorable terms, or if at all, which could
have a material and negative impact on our business and results of
operations.
2. Significant accounting policies, continued
New and amended standards adopted by the group
The Group has applied the following standards and amendments for
the first time for their annual reporting period commencing 1
January 2015:
-- Annual Improvements to IFRSs - 2010-2012 Cycle and 2011-2013 Cycle
The Group also elected to adopt the following two amendments
early:
-- Annual Improvements to IFRSs 2012-2014 Cycle, and
-- Disclosure Initiative: Amendments to IAS 1.
As these amendments merely clarify the existing requirements,
they do not affect the Group's accounting policies or any of the
disclosures.
New standards and interpretations not yet adopted
Certain new accounting standards and interpretations have been
published that are not mandatory for 31 December 2015 reporting
periods 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 and IFRS 15 is 1 January
2018 and for IFRS 16, it is 1 January 2019. The standards have not
yet been endorsed by the EU and the effective date for the Group
would actually depend on the EU endorsement effective date.
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.
Principles of consolidation
Subsidiaries are all entities (including structured entities)
over which the Group has control. The Group controls an entity when
the Group is exposed to, or has rights to, variable returns from
its involvement with the entity and has the ability to affect those
returns through its power to direct the activities of the entity.
Subsidiaries are fully consolidated from the date on which control
is transferred to the Group. They are deconsolidated from the date
that control ceases.
Intercompany transactions, balances, and unrealised gains on
transactions between Group companies are eliminated. Unrealised
losses are also eliminated unless the transaction provides evidence
of an impairment of the transferred asset. Accounting policies of
subsidiaries have been changed where necessary to ensure
consistency with the policies adopted by the Group.
When the Group ceases to consolidate because of a loss of
control, any retained interest in the entity is remeasured to its
fair value with the change in carrying amount recognised in profit
or loss. This fair value becomes the initial carrying amount for
the purposes of subsequently accounting for the retained interest
as an associate, joint venture, or financial asset.
b. Segment reporting
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 IRFS consolidated financial statements.
The chief operating decision-maker has determined that Motif has
one operating segment - the development and commercialisation of
pharmaceutical formulations. All activities take place in the
USA.
2. Significant accounting policies, continued
c. Foreign currency translation
(a) Functional and Presentation Currency
Items included in the financial statements of each of the
Group's entities are measured using the currency of the primary
economic environment in which the entity operates ("the functional
currency"). The consolidated financial statements are presented in
United States Dollars (US $), which is Motif Bio plc's functional
and presentation currency.
(b) Transactions and balances
Foreign currency transactions are translated into the functional
currency using the exchange rates at the dates of the transactions.
Foreign exchange gains and losses resulting from the settlement of
such transactions and from the translation of monetary assets and
liabilities denominated in foreign currencies at year end exchange
rates are generally recognised in profit or loss. They are deferred
in equity if they relate to qualifying cash flow hedges and
qualifying net investment hedges or are attributable to part of the
net investment in a foreign operation.
Foreign exchange gains and losses that relate to borrowings are
presented in the statement of profit or loss, within finance costs.
All other foreign exchange gains and losses are presented in the
statement of profit or loss on a net basis within other income or
other expenses.
Non-monetary items that are measured at fair value in a foreign
currency are translated using the exchange rates at the date when
the fair value was determined. Translation differences on assets
and liabilities carried at fair value are reported as part of the
fair value gain or loss. For example, translation differences on
non-monetary assets and liabilities such as equities held at fair
value through profit or loss are recognised in profit or loss as
part of the fair value gain or loss and translation differences on
non-monetary assets such as equities classified as
available-for-sale financial assets are recognised in other
comprehensive income.
d. Research and development costs
Expenditure on drug development activities is capitalised only
if all of the following conditions are met:
-- it is probable that the asset will create future economic benefits;
-- the development costs can be measured reliably;
-- technical feasibility of completing the intangible asset can be demonstrated;
-- there is the intention to complete the asset and use or sell it;
-- there is the ability to use or sell the asset; and
-- adequate technical, financial, and other resources to
complete the development and to use or sell the asset are
available.
These conditions are generally met when a filing is made for
regulatory approval for commercial production. Otherwise, costs on
research activities are recognised as an expense in the period in
which they are incurred.
At this time Motif does not meet all conditions and therefore
development costs are recorded as expense in the period in which
the cost is incurred.
e. Intangible assets
Intangible assets are stated at cost, net of any amortisation
and any provision for impairment. Where a finite useful life of the
acquired intangible asset cannot be determined, the asset is not
subject to amortisation but is tested for impairment annually
2. Significant accounting policies, continued
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or more frequently whenever events or changes in circumstances
indicate that the carrying amount may not be recoverable.
f. Impairment of non-financial assets
Assets that have an indefinite useful life are not subject to
amortisation and are tested annually for impairment, or more
frequently if events or changes in circumstances indicate that they
might be impaired. Other assets are tested for impairment whenever
events or changes in circumstances indicate that the carrying
amount may not be recoverable. An impairment loss is recognised for
the amount by which the asset's carrying amount exceeds its
recoverable amount. The recoverable amount is the higher of an
asset's fair value less costs of disposal and value in use. For the
purposes of assessing impairment, assets are grouped at the lowest
levels for which there are separately identifiable cash inflows
which are largely independent of the cash inflows from other assets
or groups of assets (cash-generating units). Non-financial assets
other than goodwill that suffered an impairment are reviewed for
possible reversal of the impairment at the end of each reporting
period. In the year ended 31 December 2015, management reviewed the
carrying amount of these assets and determined that no adjustments
to carrying values were required.
g. Financial instruments-initial recognition and subsequent measurement
A financial instrument is any contract that gives rise to a
financial asset of one entity and a financial liability or equity
instrument of another entity.
a) Financial assets, initial recognition and measurement
All financial assets, such as receivables and deposits, are
recognised initially at fair value plus, in the case of financial
assets not recorded at fair value through profit or loss,
transaction costs that are attributable to the acquisition of the
financial asset.
The Company assesses, at each reporting date, whether there is
objective evidence that a financial asset or a company of financial
assets is impaired. An impairment exists if one or more events that
has occurred since the initial recognition of the asset (an
incurred "loss event"), has an impact on the estimated future cash
flows of the financial asset or the group of financial assets that
can be reliably estimated.
b) Financial liabilities, initial recognition and
measurement
Financial liabilities are classified, at initial recognition, as
financial liabilities at fair value through profit or loss, loans
and borrowings, and payables, as appropriate. All financial
liabilities are recognised initially at fair value and, in the case
of loans and borrowings and payables, net of directly attributable
transaction costs.
The Company's financial liabilities include trade and other
payables and loans and borrowings.
c) Subsequent measurement
The measurement of financial liabilities depends on their
classification. Financial liabilities at fair value through profit
or loss include financial liabilities held for trading and
financial liabilities designated upon initial recognition as at
fair value through profit or loss. Financial assets at fair value
through profit or loss are subsequently carried at fair value.
Loans and receivables are subsequently carried at amortised cost
using the effective interest method.
h. Financial assets and liabilities
Financial assets and financial liabilities are included in the
Group's balance sheet when the Group becomes a party to the
contractual provisions of the instrument. Financial assets are
derecognised when the rights to receive cash flows from the
investments have expired or have been transferred and the Company
has transferred substantially all risks and rewards of
ownership.
2. Significant accounting policies, continued
Non-derivative financial instruments
Cash and cash equivalents
Cash and cash equivalents include bank balances, demand
deposits, and other short-term, highly liquid investments (with
less than three months to maturity) that are readily convertible
into a known amount of cash and are subject to an insignificant
risk of fluctuations in value.
Financial liabilities and equity
The Group classifies an instrument, or its component parts, on
initial recognition as a financial liability or an equity
instrument in accordance with the substance of the contractual
arrangement and the definitions of a financial liability and an
equity instrument.
An instrument is classified as a financial liability when it is
either (i) a contractual obligation to deliver cash or another
financial asset to another entity; or (ii) a contract that will or
may be settled in the Group's own equity instruments and is a
non-derivative for which the Group is, or may be, obliged to
deliver a variable number of the Group's own equity instruments or
a derivative that will, or may be, settled other than by the
exchange of a fixed amount of cash or another financial asset for a
fixed number of the Group's own equity instruments.
Incremental costs directly attributable to the issue of new
ordinary shares or options are shown in equity as a deduction, net
of tax, from the proceeds.
An equity instrument is defined as any contract that evidences a
residual interest in the assets of an entity after deducting all of
its liabilities. An instrument is an equity instrument only if the
issuer has an unconditional right to avoid settlement in cash or
another financial asset.
Trade payables
Trade payables are obligations to pay for goods or services that
have been acquired in the ordinary course of business from
suppliers. Trade payables are classified as current liabilities if
payment is due within one year or less (or in the normal operating
cycle of the business if longer). If not, they are presented as
non-current liabilities.
Trade payables are initially measured at fair value, and are
subsequently measured at amortised cost, using the effective
interest rate method.
Equity instruments
Equity instruments issued by the Company are recorded at the
proceeds received. Direct issuance costs are processed as a
deduction on equity.
Derivative financial instruments
The Group does not have a policy of engaging in speculative
transactions, nor does it issue or hold financial instruments for
trading purposes.
The Group has entered into various financing arrangements with
its investors, including convertible loans. These convertible loans
each include embedded financial derivative elements (being the
right to acquire equity in the Group at a future date for a
pre-determined price). Therefore, while the Group does not engage
in speculative trading of derivative financial instruments, it may
hold such instruments from time to time as part of its financing
arrangements.
2. Significant accounting policies, continued
Derivatives are initially recognised at fair value on the date a
derivative contract is entered into and are subsequently
re-measured at their fair value. The resulting gain or loss is
recognised in the consolidated income statement, as the Group
currently does not apply hedge accounting.
Impairment of financial assets
The Group assesses at the end of each reporting period whether
there is objective evidence that a financial asset or group of
financial assets is impaired. A financial asset or a group of
financial assets is impaired and impairment losses are incurred
only if there is objective evidence of impairment as a result of
one or more events that occurred after the initial recognition of
the asset (a "loss event") and that loss event (or events) has an
impact on the estimated future cash flows of the financial asset or
group of financial assets that can be reliably estimated.
Evidence of impairment may include indications that the debtors
or a group of debtors is experiencing significant financial
difficulty, default or delinquency in interest or principal
payments, the probability that they will enter bankruptcy or other
financial reorganisation, and where observable data indicate that
there is a measurable decrease in the estimated future cash flows,
such as changes in arrears or economic conditions that correlate
with defaults.
For loans and receivables category, the amount of the loss is
measured as the difference between the asset's carrying amount and
the present value of estimated future cash flows (excluding future
credit losses that have not been incurred) discounted at the
financial asset's original effective interest rate. The carrying
amount of the asset is reduced and the amount of the loss is
recognised in the consolidated income statement. If a loan or
held-to-maturity investment has a variable interest rate, the
discount rate for measuring any impairment loss is the current
effective interest rate determined under the contract. As a
practical expedient, the Group may measure impairment on the basis
of an instrument's fair value using an observable market price.
If, in a subsequent period, the amount of the impairment loss
decreases and the decrease can be related objectively to an event
occurring after the impairment was recognised (such as an
improvement in the debtor's credit rating), the reversal of the
previously recognised impairment loss is recognised in the
consolidated income statement.
i. Offsetting financial instruments
Financial assets and liabilities are offset and the net amount
is reported in the balance sheet when there is a legally
enforceable right to offset the recognised amounts and there is an
intention to settle on a net basis, or realise the asset and settle
the liability simultaneously. The legally enforceable right must
not be contingent on future events and must be enforceable in the
normal course of business and in the event of default, insolvency,
or bankruptcy of the Company or the counterparty.
j. Share-based payment transactions
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The fair value of options and warrants granted to employees,
directors, and consultants is normally recognised as an expense,
with a corresponding increase in equity, over the period in which
the option and warrant holders become unconditionally entitled to
the options and warrants unless incremental and directly
attributable to an equity transaction in which case it is deducted
from equity. The fair value of the options and warrants granted is
measured using an option valuation model, taking into account the
terms and conditions upon which the options were granted. The
amount recognised as an expense is adjusted to reflect the actual
number of share options and warrants that vest except where
forfeiture is due only to share prices not achieving the threshold
for vesting.
Where a third party has provided goods or services in exchange
for a compound financial instrument, such as a convertible
promissory note, and where the fair value of the goods of services
is measured directly, the fair value of the equity component is
measured as the differences between the fair value of the goods or
services received and the fair value of the debt component.
k. Financial income and expenses
Financial income comprises interest receivable on funds
invested. Financial expenses comprise interest payable.
2. Significant accounting policies, continued
Interest income and interest payable are recognised in the
income statement as they accrue, using the effective interest
method.
l. Taxation
Tax on the profit or loss for the year comprises current and
deferred tax. Tax is recognised in the income statement except to
the extent that it relates to items recognised directly in equity,
in which case it is recognised in equity.
Current tax is the expected tax payable on the taxable income
for the period, using tax rates enacted or substantively enacted at
the balance sheet date and any adjustment to tax payable in respect
of previous years.
Deferred tax is provided on temporary differences between the
carrying amounts of assets and liabilities for financial reporting
purposes and the amounts used for taxation purposes. The following
temporary differences are not provided for: the initial recognition
of goodwill; the initial recognition of assets or liabilities that
affect neither accounting nor taxable profit other than in a
business combination; and differences relating to investments in
subsidiaries to the extent that they will probably not reverse in
the foreseeable future. The amount of deferred tax provided is
based on the expected manner of realisation or settlement of the
carrying amount of assets and liabilities, using tax rates enacted
or substantively enacted at the balance sheet date.
A deferred tax asset is recognised only to the extent that it is
probable that future taxable profits will be available against
which the temporary difference can be utilised.
m. Earnings per share
The Company presents basic and diluted earnings per share (EPS)
data for its shares. Basic EPS is calculated by dividing the profit
or loss attributable to shares of the Company by the weighted
average number of shares outstanding during the period. Diluted EPS
is determined by adjusting the profit or loss attributable to
shareholders and the weighted average number of shares outstanding
for the effects of all dilutive potential shares, which comprise
share options and warrants granted to employees and non-employees.
Where the Company makes a loss, diluted EPS equates to basic
EPS.
n. Borrowings
Borrowings are recognised initially at fair value, net of
transaction costs incurred. Borrowings are subsequently measured at
amortised cost. Any difference between the proceeds (net of
transaction costs) and the redemption amount is recognised in
profit or loss over the period of the borrowings using the
effective interest method.
Debt issuance costs on loan facilities are recognised as
transaction costs of the loan to the extent that it is probable
that some or all of the facility will be drawn down. In this case,
the fee is deferred until the draw-down occurs. To the extent there
is no evidence that it is probable that some or all of the facility
will be drawn down, the fee is capitalised as a pre-payment for
liquidity services and amortised over the period of the facility to
which it relates.
o. Equity
The Company classifies an instrument, or its component parts, on
initial recognition as a financial liability or an equity
instrument in accordance with the substance of the contractual
arrangement and the definitions of a financial liability and an
equity instrument.
An instrument is classified as a financial liability when it is
either (i) a contractual obligation to deliver cash or another
financial asset to another entity; or (ii) a contract that will, or
may be, settled in the Company's own equity instruments and is a
non-derivative for which the Company is, or may be, obliged to
deliver a variable number of the Company's own equity instruments
or a derivative that will or may be settled other than by the
exchange of a fixed amount of cash or another financial asset for a
fixed number of the Company's own equity instruments.
2. Significant accounting policies, continued
Incremental costs directly attributable to the issue of new
ordinary shares or options are shown in equity as a deduction, net
of tax, from the proceeds.
An equity instrument is defined as any contract that evidences a
residual interest in the assets of an entity after deducting all of
its liabilities. An instrument is an equity instrument only if the
issuer has an unconditional right to avoid settlement in cash or
another financial asset.
Ordinary Shares
Ordinary shares are classified as equity. Incremental costs
directly attributable to the issue of new shares or options are
shown in equity as a deduction from the proceeds, net of tax.
p. Critical accounting estimates and judgements
In preparing the financial information, the Directors have to
make judgments on how to apply the Company's accounting policies
and make estimates about the future. The critical judgments that
have been made in arriving at the amounts recognised in the
financial information and the key sources of estimation uncertainty
that have a significant risk of causing a material adjustment to
the carrying value of assets and liabilities in the next financial
year, are discussed below:
Acquisition and valuation of the iclaprim assets
The directors, on assessing if the acquisition of the Nuprim
iclaprim assets was of a business or of a group of assets,
considered:
-- the identified elements of the acquired group;
-- the capability of the acquired group to produce outputs; and
-- the impact that any missing elements have on a market
participant's ability to produce outputs with the acquired
group.
As the acquired group was not accompanied by any associated
processes and because the acquired assets do not have planned
principal activities, or a plan to produce outputs, the Directors
considered the acquisition to be of a group of assets, not a
business.
The Directors use their judgement to identify the separate
intangible assets and then determine a fair value for each based
upon the consideration paid, the nature of the asset, industry
statistics, future potential, and other relevant factors. These
fair values are tested for impairment annually.
Research and development expenditures
Research expenditures are currently not capitalised because the
criteria for capitalisation are not met. At each balance sheet
date, the Group estimates the level of service performed by the
vendors and the associated costs incurred for the services
performed.
Although we do not expect the estimates to be materially
different from amounts actually incurred, the understanding of the
status and timing of services performed relative to the actual
status and timing of services performed may vary and could result
in reporting amounts that are too high or too low in any particular
period.
Share based payments
The Directors have to make judgments when deciding on the
variables to apply in arriving at an appropriate valuation of share
based compensation and similar awards including appropriate factors
for volatility, risk free interest rate, and applicable future
performance conditions and exercise patterns.
2. Significant accounting policies, continued
q. Investments in subsidiaries
Investments in subsidiaries are shown in the Company balance
sheet at cost and are reviewed annually for impairment.
3. Financial risk management
This note explains the Group's exposure to financial risks and
how these risks could affect the Group's future financial
performance.
a. Credit risk
Credit risk arises from cash and cash equivalents, deposits with
banks and financial institutions, and if a counterparty will
default on its contractual obligations resulting in financial loss
to the Group.
The credit risk on liquid funds is limited because cash balances
are held with bank and financial institutions with credit-ratings
assigned by international credit-rating agencies. All deposits are
held with banks with S&P ratings of A-2 and AA- for short term
deposits.
At 31 December 2015, no current asset receivables were aged over
three months. No receivables were impaired.
b. Liquidity risk
Liquidity risk is the risk that the Group will not be able to
meet its financial obligations as they fall due. The principal risk
to which the Group is exposed is liquidity risk.
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The Group finances its operations using cash raised through the
issue of equity. The Group manages its liquidity risk by monitoring
cash flows against forecast requirements based on an 18 month cash
forecast. The Directors acknowledge that uncertainty remains over
the ability of the Group to have the resources to fully support the
iclaprim trials. However, the Directors believe the Group will be
able to secure financing through public markets, private financing,
and partnering opportunities. In addition, since the majority of
costs are associated with the clinical trials of iclaprim, the
Directors believe the trials can be slowed or stopped. Although
these measures would have an adverse effect on the
commercialisation of iclaprim, the cost savings would extend the
Group's ability to maintain itself as a going concern.
The Group would also like to begin clinical trials of iclaprim
in other disease indications. In order to commence these trials,
the Group would need to obtain additional financing. A delay in
beginning these additional trials could lead to a decrease in the
Group's prospects for the commercialisation of iclaprim. In order
to continue the current clinical trials of iclaprim and commence
new clinical trials the Group is heavily dependent on the public
markets both in the UK and US. A downturn in the public markets,
especially in biotech, may make it difficult for the Group to
obtain sufficient funds to continue its clinical trials and the
commercialisation of iclaprim. The current clinical trials of
iclaprim have just commenced and the outcome of the trials will not
be known until the third quarter of 2017. Should the clinical trial
results be unfavorable, the Group's ability to raise additional
funds and the commercialisation of iclaprim would be severely
diminished.
In the event that we do not have adequate capital to maintain or
develop our business, additional capital may not be available to us
on a timely basis, on favorable terms, or at all, which could have
a material and negative impact on our business and results of
operations.
3. Financial risk management, continued
Contractual maturities of financial liabilities:
Between Between
1 2
and 2 and 5 Over 5
< 1 year years years years
At 31 December
2015 US $ US $ US $ US $ Total
------------------ ----------------- --------------------- -------- ------- -------------------------
Trade and other
payables 987,083 - - - 987,083
Accrued interest
payable 197,175 - - - 197,175
Payable on
completion
of clinical
trial - 500,000 - - 500,000
Other interest
bearing
loans and
borrowings 3,550,786 - - - 3,550,786
4,735,044 500,000 - - 5,235,044
----------------- --------------------- -------- ------- -------------------------
Between Between
1 2
and 2 and 5 Over 5
< 1 year years years years
At 31 December
2014 US $ US $ US $ US $ Total
------------------ ----------------- --------------------- -------- ------- -------------------------
Trade and other
payables 2,393,616 - - - 2,393,616
Accrued interest
payable 1,769,330 - - - 1,769,330
Other interest
bearing
loans and
borrowings 6,981,454 - - - 6,981,454
11,144,400 - - - 11,144,400
----------------- --------------------- -------- ------- -------------------------
c. Market risk
Foreign currency risk
The Group undertakes certain transactions denominated in foreign
currencies. Hence, exposures to exchange rate fluctuations arise.
Exchange rate exposures are managed by minimising the balance of
foreign currencies to cover expected cash flows during periods
where there is strengthening in the value of the foreign currency.
The Group holds part of its cash resources in US dollars and
British pound sterling. The valuation of the cash fluctuates along
with the US dollar/sterling exchange rate. No hedging of this risk
is undertaken.
The carrying amounts of foreign currency denominated monetary
net assets at the reporting date are as follows:
2015 2014
US $ US $
---------------- ---------- ----------------------------
Sterling - Cash 2,617,033 -
At 31 December 2015, if pounds sterling had
weakened/strengthened by 5% against the US dollar with all other
variables held constant, the loss for the year would have been US
$131,000 (2014: US $0) higher/lower.
Interest rate risk
The Group's exposure to interest rate risk is limited to the
cash and cash equivalent balance of US $28,594,347 and its
financing exposures that are at fixed rates of interest. Changes in
interest rates would have no significant impact on the profit or
losses of the Group.
d. Capital risk management
The Directors define capital as the total equity of the Company.
The Directors' objectives when managing capital are to safeguard
the Company's ability to continue as a going concern in order to
provide returns for shareholders and benefits for other
stakeholders and to maintain an optimal structure to reduce the
cost of capital. In order to maintain an optimal capital
3. Financial risk management, continued
structure, the Directors may adjust the amount of dividends paid
to shareholders, return capital to shareholders and issue new
shares to reduce debt.
4. Other income and expense items
This note provides a breakdown of the items included in other
income, finance income, and costs and an analysis of expenses by
nature.
a. Other income
2015 2014
US $ US $
---------------- --------------
Forgiveness of debt (note
19) 5,027 360,060
5,027 360,060
---------------- --------------
b. Breakdown of expenses by nature
2015 2014
US $ US $
----------------------------- ------------------ -------------------------
General and administrative
expenses
Employee benefits expenses 1,146,566 302,468
Directors' fees 380,969 -
Advisory fees 459,904 240,000
Legal and professional fees 1,277,552 510,143
Other expenses 312,189 43,505
------------------ -------------------------
3,577,180 1,096,116
------------------ -------------------------
Research and development
costs 4,680,940 -
------------------ -------------------------
Auditors' Remuneration 2015 2014
US $ US $
------------------------------- ------- -----
Fees payable to the Group's
auditors
- Audit of the Group's annual
accounts for 2015 and 2014 73,730 -
------------------------------- ------- -----
c. Finance income and costs
2015 2014
US $ US $
-------------------------- ----------------------------
Finance income
Interest from financial assets 15,028 78
-------------------------- ----------------------------
15,028 78
-------------------------- ----------------------------
Finance costs
Interest paid/payable for
financial liabilities (268,216) (449,036)
(268,216) (449,036)
Net finance costs (253,188) (448,958)
-------------------------- ----------------------------
5. Employee numbers and costs
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The monthly average number of persons employed by Motif
(including Executive Directors but excluding Non-executive
Directors) and key management personnel during the year, analysed
by category, was as follows:
12 months
ended 12 months
31 Dec ended 31
2015 Dec 2014
Executive Directors 2 1
Key management personnel 2 0
-------------------------- ---------- ----------
4 1
-------------------------- ---------- ----------
The aggregate payroll costs of Executive Directors and key
management personnel were as follows:
12 months 12 months
ended ended
31 Dec 31 Dec
2015 2014
US $ US $
------------------------------------ ---------- -----------------
Short term benefits:
Wages and salaries 935,081 210,000
Social security and other employer
costs 60,604 -
Share based payments 150,881 92,468
------------------------------------ ---------- -----------------
1,146,566 302,468
------------------------------------ ---------- -----------------
6. Directors' remuneration
Salaries Benefits Social 2015 2014
and fees (1) Bonuses in kind security Total Total
US $ US $ US $ US $ US $ US $
--------------- ----------------- -------------------- ------------------ --------- -------------- ---------------
Executive
Graham Lumsden 315,000 225,000 - 17,180 557,180 -
Robert
Bertoldi 55,558 75,000 - 4,568 135,126 -
Non-executive
Richard Morgan 63,372 153,700 - - 217,072 -
Charlotta
Ginman 28,741 - - 3,301 32,042 -
Jonathan Gold 25,881 - - - 25,881 -
Zaki Hosny 28,756 - - - 28,756 -
Mary Lake
Polan 25,881 - - - 25,881 -
John Stakes 28,756 - - - 28,756 -
Bruce Williams 25,881 - - - 25,881 -
--------------- ----------------- -------------------- ------------------ --------- -------------- ---------------
Total 597,826 453,700 - 25,049 1,076,575 -
--------------- ----------------- -------------------- ------------------ --------- -------------- ---------------
The highest paid director's aggregate emolument was US $557,180
for the year. The director did not exercise share options during
the year.
(1) Bonuses were awarded to Executive Directors and the Chairman
in recognition of their extraordinary service in successfully
completing the merger with Nuprim Inc., the AIM listing, a
secondary fund raising, QIDP designation from the FDA, and the
initiation of the Phase III clinical trials.
6. Directors' remuneration, continued
Directors of the Company have been awarded rights to subscribe
for shares in the Company as set out below.
1 January 31 December Exercise Grant Expiry
price
US
2015 Granted 2015 $ date date
---------------- ------------------ -------------- -------------------- --------- ------- -------
Richard 1 Jan 1 Jan
Morgan 73,215 - 73,215 $0.70 2010 2020
1 Jan 1 Jan
6,179 - 6,179 $0.70 2011 2021
4 Dec 4 Dec
502,950 - 502,950 $0.14 2014 2024
582,344 - 582,344
------------------ -------------- --------------------
Robert 1 Jan 1 Jan
Bertoldi 53,887 - 53,887 $0.70 2010 2020
4 Dec 4 Dec
251,475 - 251,475 $0.14 2014 2024
305,362 - 305,362
------------------ -------------- --------------------
Charlotta 4 Dec 4 Dec
Ginman 251,475 - 251,475 $0.14 2014 2024
251,475 - 251,475
------------------ -------------- --------------------
Jonathan 1 Jan 1 Jan
Gold 73,502 - 73,502 $0.70 2010 2020
1 Jan 1 Jan
5,964 - 5,964 $0.70 2011 2021
4 Dec 4 Dec
251,475 - 251,475 $0.14 2014 2024
330,941 - 330,941
------------------ -------------- --------------------
18 Jun 18 Jun
Zaki Hosny 53,888 - 53,888 $0.70 2009 2019
1 Jan 1 Jan
14,370 - 14,370 $0.70 2010 2020
1 Jan 1 Jan
2,587 - 2,587 $0.70 2011 2021
30 Jan 30 Jan
107,774 - 107,774 $0.14 2013 2023
4 Dec 4 Dec
251,475 - 251,475 $0.14 2014 2024
430,094 - 430,094
------------------ -------------- --------------------
Graham 25 May 25 May
Lumsden 574,800 - 574,800 $0.14 2013 2023
4 Dec 4 Dec
2,874,000 - 2,874,000 $0.14 2014 2024
3,448,800 - 3,448,800
------------------ -------------- --------------------
Mary Lake 1 Jan 1 Jan
Polan 67,036 - 67,036 $0.70 2010 2020
1 Jan 1 Jan
5,461 - 5,461 $0.70 2011 2021
4 Dec 4 Dec
251,474 - 251,474 $0.14 2014 2024
323,971 - 323,971
------------------ -------------- --------------------
1 Jan 1 Jan
John Stakes 62,366 - 62,366 $0.70 2010 2020
1 Jan 1 Jan
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2,802 - 2,802 $0.70 2011 2021
4 Dec 4 Dec
251,474 - 251,474 $0.14 2014 2024
316,642 - 316,642
------------------ -------------- --------------------
1 Jan 1 Jan
Bruce Williams 67,252 - 67,252 $0.70 2010 2020
16 Jan 16 Jan
28,740 - 28,740 $0.70 2010 2020
15 Nov 16 Jan
71,850 - 71,850 $0.70 2010 2020
1 Jan 1 Jan
2,802 - 2,802 $0.70 2011 2021
4 Dec 4 Dec
251,474 - 251,474 $0.14 2014 2024
422,118 - 422,118
------------------ -------------- --------------------
7. Income tax expense
Recognised in the income statement:
12 months 12 months
ended ended
31 Dec 31 Dec
Current tax expense 2015 2014
US $ US $
---------------------- ---------- ----------
UK Corporation taxes - -
Overseas taxes 774 876
774 876
---------------------- ---------- ----------
The main rate of UK corporation tax was reduced from 21% to 20%
from 1 April 2015 and has been reflected in these financial
statements.
The tax expense recognised for the year is lower (2014: lower)
than the standard rate of corporation tax in the UK of 20.25%
(2014: 21.5%). The differences are reconciled below:
Reconciliation of effective tax rate: 2015 2014
US $ US $
--------------------------------------------- -------------------- ----------------------
Loss on ordinary activities before taxation (8,515,925) (1,185,014)
--------------------------------------------- -------------------- ----------------------
UK Corporation tax at 20.25% (355,889) -
Overseas tax at higher rate (2,297,873) (402,905)
Effects of:
Unrecognised losses (2,652,988) (402,029)
Other adjustments-overseas taxes 774 876
--------------------------------------------- -------------------- ----------------------
Total tax charge 774 876
--------------------------------------------- -------------------- ----------------------
There is an unrecognised deferred tax asset of US $298,771,
relating to deferred tax on losses generated of US $1,757,475 in
the UK.
8. 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 year. For comparative
purposes, the weighted average number of shares in issue in the
year ended 31 December 2014 have been adjusted to reflect the
reverse stock split in the capital of Motif BioSciences Inc. on 13
March 2015. In accordance with IAS 33, where the Company has
reported a loss for the period, the shares are anti-dilutive.
12 months
12 months ended
ended 31 31 Dec
Dec 2015 2014
US $ US $
------------------------------------ ---------------- ------------
Loss after taxation (8,516,699) (1,185,890)
Basic and diluted weighted average
shares in issue 61,225,922 6,428,926
Basic and diluted loss per share (0.14) (0.18)
------------------------------------- ---------------- ------------
8. Loss per share, continued
The following potentially dilutive securities outstanding at 31
December 31, 2015 and 2014 have been excluded from the computation
of diluted weighted average shares outstanding, as they would be
antidilutive.
2015 2014
US $ US $
----------------------------- ------------- ------------------
Convertible promissory notes 14,510,770 -
Warrants 6,925,962 -
Share options 7,182,674 -
------------- ------------------
28,619,406 -
------------- ------------------
9. Intangible assets
As of 1 January 2014
Cost -
Accumulated amortisation and impairment -
Net book amount at 1 January 2014 -
Additions -
Amortisation charge -
Net book amount at 31 December 2014 -
----------------------------------------- -----------------
As of 31 December 2014
Cost -
Accumulated amortisation and impairment -
Net book amount at 31 December 2014 -
Additions 6,195,748
Amortisation charge -
Net book amount at 31 December 2015 6,195,748
----------------------------------------- -----------------
Motif BioSciences Inc., as the result of the merger agreement
with Nuprim Inc., acquired the exclusive rights to Nuprim's
iclaprim assets and the rights to acquire 600 kilograms of iclaprim
API over a period ending 31 December 2017. Iclaprim was originally
discovered by F. Hoffman-La Roche Ltd and was licensed to and
developed by Arpida AG on 1 June 2001. On 30 November 2009, Acino
Holding Ltd acquired the iclaprim business from Arpida Ltd. Acino
Phara AG sold all rights, title and interest to iclaprim to Life
Sciences Management Group, Inc. ("LSMG") on 13 September 2013. LSMG
then assigned all of its rights to iclaprim to Nuprim Inc. As part
of the transaction Motif BioSciences Inc. is responsible for costs
and expenses related to or arising from the transfer of the
iclaprim assets, including storage and delivery costs of the
physical drug supply and inventory which are due and payable after
17 October 2014 and Motif BioSciences Inc. must assume and accept
the terms and obligations arising under the Acino-LSMG agreement,
including payment obligations which principally relate to the
storage costs of the physical drug supply. Motif BioSciences Inc.
is also responsible for any third-party legal or administrative
costs incurred by Nuprim in connection with the transaction and any
obligations arising under a sale and purchase agreement between F.
Hoffmann-La Roche Ltd, Hoffmann-La Roche Inc. and Arpida Ltd.,
dated 1 June 2001 which principally relates to a royalty of 1-5%,
depending on the final drug developed upon commercialisation. Motif
BioSciences Inc. issued 1,513,040 (post reverse stock split) shares
of common stock to the shareholders of Nuprim that were held in
escrow until the closing of the reorganisation. These shares of
common stock in Motif BioSciences Inc. were converted into ordinary
shares in Motif Bio plc on admission.
On 31 December 2014, Motif BioSciences Inc. finalised the merger
agreement. Upon admission, 9,805,400 ordinary shares of Motif Bio
plc and 9,432,033 warrants were issued to the former Nuprim
shareholders. The warrants have an exercise price of 20 pence and
expire on the date ten years from the closing date of the
transaction. In the event that Motif BioSciences Inc. fails to
advance the development of iclaprim by commencing clinical
development by 15 February 2017, the former Nuprim shareholders
have the right to acquire the iclaprim assets for a purchase price
of US $10,000. Motif BioSciences Inc. has commenced clinical
development of iclaprim. The right of the Nuprim shareholders to
acquire the iclaprim assets has therefore ended.
9. Intangible assets, continued
The Directors do not believe that the merger between Motif
BioSciences Inc. and Nuprim Inc. meets the definition of an
acquisition of a business as set out in IFRS 3 and is therefore
accounted for as an acquisition of an asset.
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The fair value of the assets acquired under the merger
arrangement represent the aggregate estimated value of:
-- 11,318,439 ordinary shares in Motif Bio plc at the placing price of 20 pence per share;
-- 9,432,033 non-assignable warrants at the placing price of 20 pence per ordinary share; and
-- a milestone payment of US $500,000 to be paid by Motif
BioSciences Inc. to Acino upon completion of the first Phase III
trial.
The value of the warrants has been estimated using the Black
Scholes option pricing model with appropriate factors for
volatility and risk free interest rate. The Directors consider the
separable value of the active pharmaceutical ingredients is
unlikely to constitute a material component of the fair value of
the assets acquired. No discount has been applied to the expected
milestone payment of US $500,000 given the commencement of the
phase III trial is deemed to have crystalised the liability that
management expect to be settled by the end of 2017.
Details of the purchase consideration and amounts attributed to
net assets acquired are as follows:
US $
--------------------
Purchase consideration:
Ordinary shares in Motif Bio
plc 3,355,375
Warrants to subscribe for
ordinary shares in Motif Bio
plc 2,340,373
Total purchase consideration 5,695,748
--------------------
Iclaprim assets 6,195,748
Milestone payment (500,000)
Net assets acquired 5,695,748
--------------------
As the asset is not yet available for commercial use, no
amortisation has been charged to date.
The Group performs an impairment test over the asset on an
annual basis. The asset, iclaprim, is a novel antibiotic drug
designed to be effective against bacteria that have developed
resistance to other antibiotics. Iclaprim is currently in two Phase
III studies in ABSSSI, a common serious infectious disease
involving multi-drug resistant bacteria. Motif has engaged Covance,
a leading clinical research organisation to manage the Phase III
studies at an approximate cost of US $50 million. Six hundred
patients will be dosed in each study over a period of approximately
18 months. The first patient was dosed in March 2016. Motif
anticipates a decision on approvability from the FDA in 2018. As
iclaprim is being actively developed in two Phase III studies and
the potential market for iclaprim is several hundred million US
dollars, there is no impairment at 31 December 2015.
10. Prepaid expenses and other receivables
Group Company
------------------------------------------ ---------------------------------------
12 months 12 months 12 months 12 months
ended ended ended ended
Amounts due within one 31 Dec 31 Dec 31 Dec 31 Dec
year 2015 2014 2015 2014
US $ US $ US $ US $
----------------------------- -------------------- -------------------- ----------------- --------------------
Other receivables and
prepayments 167,657 210,661 26,609 -
Amounts due from subsidiary - - 411,463 -
167,657 210,661 438,072 -
----------------------------- -------------------- -------------------- ----------------- --------------------
Included in other receivables at 31 December 2014 is an amount
of US $210,583 in relation to the acquisition of the iclaprim
assets. On 17 October 2014, Motif BioSciences Inc. issued 2,105,832
common shares to the shareholders of Nuprim Inc. at the execution
of an agreed upon term sheet. Under the term sheet, Motif
BioSciences Inc. merged Nuprim Inc. into Motif BioSciences Inc. and
acquired the exclusive rights to Nuprim's iclaprim assets, the
issued shares of common stock in Motif BioSciences Inc. were held
in escrow until the closing of the reorganisation. The Directors
considered the fair value of the common shares in Motif BioSciences
Inc. at the date of issue to be US $0.10 per share.
The maximum exposure to credit risk at the end of each reporting
period is the fair value of each class of receivables set out
above. The Company held no collateral as security. The Directors
estimate that the carrying value of receivables approximated their
fair value.
11. Cash and cash equivalents
Group Company
------------------------------------ --------------------------------------
31 Dec 31 Dec 31 Dec 31 Dec
2015 2014 2015 2014
US $ US $ US $ US $
-------------- ---------------- ------------------ -------------- ----------------------
Cash at bank 28,594,347 3,281 28,543,181 -
28,594,347 3,281 28,543,181 -
-------------- ---------------- ------------------ -------------- ----------------------
12. Trade and other payables
Group Company
----------------------------------------- ------------------------------------------
12 months 12 months 12 months 12 months
ended ended ended ended
Amounts due within one 31 Dec 31 Dec 31 Dec
year 2015 2014 31 Dec 2015 2014
US $ US $ US $ US $
--------------------------- ------------------ --------------------- -------------------- --------------------
Trade payables 108,247 22,243 - -
Accrued expenses 877,238 2,241,644 57,488 -
Amounts due to affiliates 1,598 129,729 - -
987,083 2,393,616 57,488 -
--------------------------- ------------------ --------------------- -------------------- --------------------
Included in trade and other payables were amounts due to
affiliates in respect of accrued interest on loan notes (see note
13) and other liabilities as follows:
Amounts due to Amphion
Innovations plc 78,409 1,513,080 - -
Amounts due to Amphion
Innovations US Inc 110,769 177,463 - -
------------------------ -------- ----------
189,178 1,690,543 - -
------------------------ -------- ----------
The Directors estimate that the carrying value of trade and
other payables approximated their fair value.
13. Other interest bearing loans and borrowings
Group Company
------------------------------------------ ------------------------------------------
12 months 12 months 12 months 12 months
ended ended ended ended
Amounts due within one 31 Dec 31 Dec 31 Dec 31 Dec
year 2015 2014 2015 2014
US $ US $ US $ US $
----------------------------- -------------------- -------------------- -------------------- --------------------
Convertible promissory
notes - 200,000 - -
Notes payable to affiliates 3,550,786 6,781,454 - -
Accrued interest expense 197,175 1,769,330
----------------------------- -------------------- -------------------- -------------------- --------------------
3,747,961 8,750,784 - -
----------------------------- -------------------- -------------------- -------------------- --------------------
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The convertible promissory notes were issued in July 2008 by
Motif BioSciences Inc. The notes accrued interest at 5% per annum
until maturity and accrued interest at 7% after maturity. In the
event Motif BioSciences Inc. received aggregate gross proceeds that
equaled or exceeded US $4,000,000 from a financing that includes
the offering of the notes including conversion of Motif BioSciences
Inc.'s existing debt, the principal amount of these notes and the
accrued but unpaid interest would automatically be converted into
shares of Motif BioSciences Inc.'s Series D preferred shares, at a
per share price equal to the lower of US $4.00 and the lowest sales
price of the Motif BioSciences Inc.'s preferred shares in relevant
prior offerings. At any time prior to the occurrence of a mandatory
conversion, the note holder could convert the principal and accrued
but unpaid interest into shares of Motif BioSciences Inc.'s Series
D preferred shares at a per share price equal to the lower of US
$4.00 and the lowest sales price of the Motif BioSciences Inc.'s
preferred stock in relevant prior offerings. On 20 January 2015,
the convertible promissory noteholders exercised the option,
conditional upon Motif Bio plc's admission on AIM, to convert US
$200,000, of convertible promissory notes and US $78,787 of accrued
interest into shares of Motif BioSciences Inc. On Admission, the
shares were converted into ordinary shares of Motif Bio plc under
the terms of the Motif Merger Agreement.
The notes payable to affiliates are demand notes from a
shareholder of the Group - Amphion Innovations plc and its
subsidiary undertaking, Amphion Innovations US Inc. At 31 December
2014, the notes accrued interest at 5% per annum. If the principal
or accrued interest remained outstanding at such time as the Motif
BioSciences Inc. concluded an equity financing that equaled or
exceeded one million US dollars, the note holder could convert all
or part of the principal balance plus accrued but unpaid interest
into the securities of Motif BioSciences Inc. issued in the
financing at a conversion rate equal to the price per security at
which the securities are issued in the financing. On 1 April 2015,
Amphion Innovations plc converted US $6,000,000 of notes and
accrued interest into shares of Motif BioSciences Inc. The shares
were converted into ordinary shares of Motif Bio plc upon Admission
under the terms of the Motif Merger Agreement. Convertible
promissory notes were issued for Amphion Innovations plc's
remaining balance of US $1,471,700 and Amphion Innovations US
Inc.'s balance of US $2,079,086 that includes unpaid accrued
interest and advisory and consultancy fees. The new notes, which
accrue interest at 7% per annum, mature on 31 December 2016 and can
be converted into ordinary shares of Motif Bio plc at the rate of
US $0.1758 per share, and have been accounted for under IFRS2.
In January 2015, Motif BioSciences Inc. entered into four
convertible promissory notes totaling US $704,210 as part of a
pre-Admission fundraising. Upon admission, the notes were converted
into 2,612,766 shares of Motif Bio plc. Motif Bio plc issued
499,570 warrants to noteholders with an exercise price of 20 pence
per share. The expiration date for 176,246 of the warrants was 31
December 2015 and 31 December 2016 for 323,324 of the warrants.
14. Share based payments
Motif BioSciences Inc. issued options and warrants to employees,
directors, consultants, and note holders. As part of the merger
between Motif Acquisition Sub, Inc. and Motif BioSciences Inc.,
described in note 17, each outstanding share option granted by
Motif BioSciences Inc. was assumed and converted by Motif Bio plc
into options to subscribe for ordinary shares in Motif Bio plc. The
number of share options and the exercise prices have been adjusted
to reflect the reverse stock split in the capital of Motif
BioSciences Inc. on 13 March 2015.
On 4 December 2014, Motif BioSciences Inc. adopted a Share
Option Plan (the "Plan") under which options can be granted to
employees, consultants, and directors. Under the Plan 9,304,575
(post reverse stock split) options were issued in 2014 that will
vest over three years and expire in ten years from the date of
grant.
Motif Bio plc adopted a Share Option Plan (the "New Plan") on 1
April 2015. This new plan replaces Motif BioSciences Inc.'s
previous share plan. There were no changes to the fair value of
share options granted under the Plan with the only change being to
grant the holders shares in Motif Bio plc rather than Motif
BioSciences Inc. upon exercising options. The exercise price for
each option will be established in the discretion of the Board
provided that the exercise price for each option shall not be less
than the nominal value of the relevant shares if the options are to
be satisfied by a new issue of shares by the Company and provided
that the exercise price per share for an option shall not be less
than the fair market value of a share on the effective date of
grant of the option. Options will be exercisable at such times or
upon such events and subject to such terms, conditions, performance
criteria, and restrictions as determined by the Board on grant
date. However, no option shall be exercisable after the expiration
of ten years after the effective date of grant of the option. In
2015, 1,000,000 options were issued under the New Plan that will
expire in ten years and vest over three years with no further
performance criteria.
Motif Bio plc issued 642,384 warrants to its nominated advisor,
642,384 warrants to its broker, and 82,321 warrants to a
fundraising advisor in part consideration for their participation
in the admission. The warrants have an exercise price of 20 pence
per share and expire on the fifth anniversary of admission.
On admission, 9,432,033 warrants were issued to the former
Nuprim shareholders with an exercise price of 20 pence per share
and expire on the tenth anniversary of admission (note 9) and
499,570 warrants were issued to the participants of the
pre-admission fundraiser with an exercise price of 20 pence per
share. The expiration date for 176,246 of the warrants was 31
December 2015 and 31 December 2016 for 323,324 of the warrants
(note 13).
For options exercised, the weighted average share price in 2015
was US $0.22 (2014: US $0.10).
Number Weighted
of average
share exercise
options price
US $
--------------------------------- ---------------------- ---------
Outstanding at 1 January 2014 5,993,793 0.727
Granted during the year 9,520,125 0.139
Forfeited during the year (468,221) 0.157
Exercised during the year (395,175) 0.084
Expired during the year (515,331) 1.218
Outstanding at 31 December 2014 14,135,191 0.349
Granted during the year 12,298,692 0.340
Forfeited during the year (915,923) 0.376
Exercised during the year (363,054) 0.216
Expired during the year (188,320) 4.175
Outstanding at 31 December 2015 24,966,586 0.316
----------------------
14. Share based payments, continued
The fair value of options and warrants has been valued using the
Black Scholes option pricing model. Volatility has been estimated
by reference to historical stock price data of the Group. The
assumptions for each option grant were as follows:
12 months 12 months
ended 31 ended 31
Dec 2015 Dec 2014
---------------------------------- ---------- ----------------
Weighted average share price (US
$) 0.53 0.14
Weighted average exercise price
(US $) 0.53 0.14
Expected volatility 79-94% 80-84%
Number of periods to exercise 10 years 10 years
2.18 - 2.15 -
Risk free rate 2.64% 2.64%
Expected dividends - -
The range of exercise prices of the options at 31 December 2015
were US $0.14-$0.87 (31 December 2014: US $0.14-$4.18). The
weighted average remaining contractual life of the outstanding
options is 7.9 years. The options will be equity settled. The share
price used for the share option plan prior to being traded on AIM
was based on management's assessment of the valuation of the Group
given the net assets and future potential of the Group at the time
of granting.
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The total expense recognised for the years arising from
stock-based payments are as follows:
12 months 12 months
ended 31 ended 31
Dec 2015 Dec 2014
US $ US $
----------------------------- ---------- ----------
Share based payment expense 325,908 300,147
------------------------------ ---------- ----------
Cost of issuance charged to
equity 339,216 -
------------------------------ ---------- ----------
15. Share capital
Allotted, called up, and fully
paid: Number US $
-------------------------------- ----------------- ----------------------
In issue at 31 December 2014 100 -
Issued:
Ordinary shares of 1p each 36,726,242 544,378
Ordinary shares of 1p each 9,805,400 145,341
Ordinary shares of 1p each 657,894 9,752
Ordinary shares of 1p each 2,612,766 38,728
Ordinary shares of 1p each 14,436,140 215,375
Ordinary shares of 1p each 82,627 1,269
Ordinary shares of 1p each 25,147 390
Ordinary shares of 1p each 44,000,000 686,180
Ordinary shares of 1p each 140,321 2,128
Ordinary shares of 1p each 53,887 825
Ordinary shares of 1p each 25,147 389
Ordinary shares of 1p each 35,925 536
108,601,496 1,645,291
----------------- ----------------------
15. Share capital, continued
Motif Bio Limited was incorporated on 20 November 2014 with 100
ordinary shares of 1 pence each, which was subscribed for unpaid.
The shares were transferred upon capitalisation.
On 2 April 2015, Motif Bio plc issued 36,726,242 ordinary shares
to the Motif BioSciences Inc. shareholders as consideration for the
transfer of the entire issued common stock of Motif BioSciences
Inc. to the Company.
On 2 April 2015, Motif Bio plc issued 9,805,400 ordinary shares
to the former Nuprim shareholders as consideration for the merger
of Motif BioSciences Inc. and Nuprim.
On 2 April 2015, Motif Bio plc issued 657,894 ordinary shares to
a creditor of Motif BioSciences Inc. in payment of the balance
due.
On 2 April 2015, Motif Bio plc issued 2,612,766 shares to the
pre-admission note holders upon conversion of the convertible
promissory notes.
On 2 April 2015, Motif Bio plc issued 14,436,140 ordinary shares
upon its admission on AIM at the price of 20 pence per share.
During 2015, 186,808 ordinary shares were issued upon the
exercise of options and 176,246 ordinary shares were issued upon
the exercise of warrants.
On 21 July 2015, Motif Bio plc placed 44,000,000 new ordinary
shares at a placing price of 50 pence per ordinary share for total
net proceeds of GBP20,737,583 (US $32,340,260).
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 re-organisation 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
re-organisation and not a business combination. The re-organisation
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.
A minor fair value adjustment is also included in the
reorganization reserve. This represents the uplift to fair value of
the initial deposit shares in Motif BioSciences Inc. issued to the
shareholders of Numprim Inc. on the execution of the agreed upon
term sheet of the Nuprim merger (note 9), which were converted to
shares in Motif Bio plc on admission to AIM.
16. Financial assets and financial liabilities
The Group holds the following financial instruments:
Group Company
---------------------------------- ----------------------------------
Financial Financial
assets assets
at amortised at amortised
cost cost
Financial assets US $ US $
------------------------------ ---------------------------------- ----------------------------------
2015
Prepaid expenses and other
receivables 167,657 26,609
Due from affiliates - 411,463
Cash and cash equivalents 28,594,347 28,543,181
28,762,004 28,981,253
---------------------------------- ----------------------------------
2014
Notes receivable 12,000 -
Prepaid expenses and other
receivables 210,661 -
Cash and cash equivalents 3,281 -
225,942 -
---------------------------------- ----------------------------------
Group Company
---------------------------------- ----------------------------------
Financial Financial
liabilities liabilities
at amortised at amortised
cost cost
Financial liabilities US $ US $
------------------------------ ---------------------------------- ----------------------------------
2015
Trade and other payables 1,184,258 57,488
Payable on completion of
clinical trial 500,000 -
Other interest bearing loans
and borrowings 3,550,786 -
5,235,044 57,488
---------------------------------- ----------------------------------
2014
Trade and other payables 4,162,946 -
Payable on completion of
clinical trial - -
Other interest bearing loans
and borrowings 6,981,454 -
11,144,400 -
---------------------------------- ----------------------------------
17. Group reorganisation by plan of merger
On 18 February 2015, Motif Bio Limited incorporated a Delaware
subsidiary, Motif Acquisition Sub, Inc. On 27 March 2015, Motif
BioSciences Inc., Motif Bio Limited, and Motif Acquisition Sub,
Inc. entered into a plan of merger where, upon admission, Motif
Acquisition Sub, Inc. merged with and into Motif BioSciences Inc.
and Motif BioSciences Inc. continued as the surviving entity and
became a wholly owned subsidiary of Motif Bio plc.
The former Motif BioSciences Inc. shareholders were issued with
36,726,242 ordinary shares in Motif Bio plc in exchange for their
common stock in Motif BioSciences Inc. so that immediately
following the merger the former Motif BioSciences Inc. shareholders
own an equivalent number of ordinary shares in Motif Bio plc as the
number of shares of common stock that they had previously owned in
Motif BioSciences Inc. All outstanding, unexercised, and vested
stock options over shares of common stock in Motif BioSciences Inc.
were converted into options over ordinary shares in Motif Bio
plc.
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The Directors consider the acquisition of the entire issued
common stock of Motif BioSciences Inc. by Motif Bio plc in exchange
for equivalent equity participation in Motif Bio plc to be a group
re-organisation and not a business combination and to fall outside
the scope of IFRS 3 given it meets the requirements of IAS27
paragraph 13. Having considered the requirements of IAS 8 and the
relevant UK and US guidance, the transaction is accounted for on a
merger or pooling of interest basis as if both entities have always
been combined, using book values, with no fair value adjustments
made nor goodwill recognised
18. Subsidiaries
Method
used
Country to account
of Percentage Percentage for
voting
Company name incorporation shareholding power investment
------------------- --------------- ------------- ----------- --------------
Motif BioSciences Delaware,
Inc. USA 100% 100% Consolidation
The principal activity of Motif BioSciences Inc. is proprietary
drug discovery research and development.
19. Related party transactions
Transactions with Amphion Innovations plc and Amphion
Innovations US Inc.
At 31 December 2015, Amphion Innovations plc owned 26.08% of the
issued ordinary shares in Motif Bio plc. In addition, Amphion
Innovations plc and its wholly owned subsidiary undertaking,
Amphion Innovations US Inc., (together the "Amphion Group") have
provided funding for the activities of Motif BioSciences Inc.
through the issue of convertible interest bearing loan notes.
Richard Morgan and Robert Bertoldi were directors of both Motif Bio
plc and Amphion Innovations plc in the period. Transactions between
the Group and the Amphion Group are disclosed below:
12 months 12 months
ended ended
31 Dec 31 Dec
2015 2014
US $ US $
-------------------------------------- ---------- ----------
Amounts due to Amphion Innovations
plc - 116,777
Amounts due to Amphion Innovations
US Inc. 1,599 12,952
Notes payable to Amphion Innovations
plc 1,471,700 5,894,746
Notes payable to Amphion Innovations
US Inc. 2,079,086 886,707
Accrued and unpaid interest on loan
notes 189,178 1,690,543
Interest expense 189,178 435,036
--------------------------------------- ---------- ----------
On 1 April 2015, Motif Bio plc entered into an Advisory and
Consultancy Agreement with Amphion Innovations US Inc. The
consideration for the services is US $120,000 per annum. In the
event that Motif Bio plc raises a minimum of GBP5,000,000 in gross
proceeds on AIM Admission or a secondary raise, a one-time payment
of US $300,000 will be paid to Amphion Innovations US Inc. This
amount was paid on 21 July 2015. The agreement is for an initial
period of twelve months and will automatically renew each year on
the anniversary date unless either party notifies the other by
giving 90 days written notice prior to expiration.
On 1 April 2015, Motif Bio plc entered into a Consultancy
Agreement with Amphion Innovations plc for Robert Bertoldi, an
employee of Amphion Innovations plc, to provide services to the
Group. The consideration for the services is US $5,000 per month.
On 1 November 2015, the consideration increased to US $180,000
annually. The agreement is for an initial period of twelve months
and will automatically renew each year on the anniversary date
unless either party notifies the other by giving 90 days written
notice prior to expiration.
Transactions with key management personnel
Other income includes US $5,027 (2014: US $284,842) from
forgiveness of debt related to a Director of the Company. This
resulted from a settlement agreement regarding salary owed to the
Director from his term as CEO.
The Directors are responsible for planning, directing, and
controlling the activities of the Company. Transactions between the
Company and its key management personnel and are disclosed in notes
5 and 6 above.
19. Related party transactions, continued
Directors' remuneration
Salaries Benefits Social 2015 2014
and fees Bonuses in kind security Total Total
US $ US $ US $ US $ US $ US $
--------------- ----------------- -------------------- ------------------ --------- -------------- ---------------
Executive
Graham Lumsden 315,000 225,000 - 17,180 557,180 -
Robert
Bertoldi 55,558 75,000 - 4,568 135,126 -
Non-executive
Richard Morgan 63,372 153,700 - - 217,072 -
Charlotta
Ginman 28,741 - - 3,301 32,042 -
Jonathan Gold 25,881 - - - 25,881 -
Zaki Hosny 28,756 - - - 28,756 -
Mary Lake
Polan 25,881 - - - 25,881 -
John Stakes 28,756 - - - 28,756 -
Bruce Williams 25,881 - - - 25,881 -
--------------- ----------------- -------------------- ------------------ --------- -------------- ---------------
Total 597,826 453,700 - 25,049 1,076,575 -
--------------- ----------------- -------------------- ------------------ --------- -------------- ---------------
20. Post balance sheet events
In January 2016, the Group appointed U.S. healthcare investment
bank MTS Health Partners to advise on its future financing options
within the U.S. market.
In February 2016, Motif BioSciences Inc. entered into an
agreement with BAL Pharma Consulting, LLC for the development and
planning of the commercialisation of iclaprim.
In March 2016, the Group initiated dosing in the iclaprim Phase
III Trials for the treatment of acute bacterial skin and skin
structure infections (ABSSSIs). These clinical trials will assess
the efficacy and safety of iclaprim compared to a standard of care
antibiotic, vancomycin, for the treatment of ABSSSIs.
In March 2016, the Group appointed specialist adviser the
Fulford Group Ltd. to assist Motif in developing and implementing
strategies to commercialise iclaprim in territories outside of the
USA.
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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