TIDMMTFB
RNS Number : 2361H
Motif Bio PLC
16 August 2016
August 16 2016
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART
DIRECTLY OR INDIRECTLY IN, INTO OR FROM ANY JURISDICTION WHERE TO
DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR
REGULATIONS OF SUCH JURISDICTION
This announcement contains inside information
Motif Bio plc
("Motif Bio", or "the Company")
Interim Results
Second Quarter and Half-Year 2016 Financial Results and
Operational Progress
Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical
company specialising in developing novel antibiotics, announces
financial results for the second quarter and half-year ended June
30, 2016.
Business Update
-- On March 2, 2016 we announced the dosing of the first patient
in our two REVIVE (Randomized Evaluation IntraVenous Iclaprim
Vancomycin trEatment) Phase 3 clinical trials in Acute Bacterial
Skin and Skin Structure Infections (ABSSSI). We are enrolling and
dosing patients in two global Phase 3 clinical trials with an
intravenous (IV) formulation of iclaprim, for the treatment of
ABSSSI. Data from the two trials are expected in the second half of
2017.
-- In March 2016, we announced that we had appointed The Fulford
Group Ltd to assist Motif Bio in developing and implementing
strategies to commercialise iclaprim in territories outside of the
United States.
-- We plan to complete preparations for our INSPIRE (Iclaprim
for NoSocomial PneumonIa gRam- positive pathogEns) Phase 3 clinical
trial with iclaprim in patients with Hospital Acquired Bacterial
Pneumonia (HABP), including patients with Ventilator Associated
Bacterial Pneumonia (VABP), by the end of 2016.
-- In addition to our clinical programmes, we have a preclinical
development programme underway to identify a formulation of
iclaprim suitable for adolescent and pediatric patients.
-- We are also developing IV and oral formulations of MTF-101, a
diaminopyrimidine that may be suitable for testing in clinical
trials to demonstrate safety and efficacy in patients with
osteomyelitis and patients with prosthetic joint infections.
Financial Highlights
-- At June 30, 2016 and December 31, 2015, we had cash and cash
equivalents of approximately US$19.5 million and US$28.6 million,
respectively.
-- Net cash used in operating activities was US$8.9 million in
the six months ended June 30, 2016, which reflects the continuation
of the clinical development of iclaprim. Net cash used in operating
activities was US$1.2 million for the six months ended June 30,
2015, reflecting the commencement of clinical development of
iclaprim.
-- General and administrative expenses increased by US$0.8
million, to US$1.9 million, in the six months ended June 30, 2016
from US$ 1.1 million in the six months ended June 30, 2015. This
increase was primarily attributable to: (i) an increase in
personnel related expenses; (ii) the costs associated with being a
public company in the United Kingdom; and (iii) increases in the
costs of outside professional services, including commercial
evaluation and strategy services, investor relations and other
consulting services.
-- Research and development expenses increased by US$11.4
million to US$12.0 million in the six months ended June 30, 2016
from US$0.6 million in six months ended June 30, 2015. This
increase was primarily attributable to the commencement of iclaprim
clinical development. For the six months ended June 30, 2016,
US$10.1 million was spent in relation to contract research
organization expenses, US$1.0 million in relation to clinical
operations and US$0.9 million in relation to chemistry and
manufacturing development and other non-clinical development.
Post period highlights
-- Motif Bio has deferred pricing of its proposed public
offering of American Depositary Shares ("ADSs") and listing of ADSs
on the NASDAQ Global Market. The Company remains in registration
with the Securities and Exchange Commission and is continuing to
engage with investors.
"We are very pleased that our lead product candidate, iclaprim,
is now in the final stage of development following the dosing of
the first patient in March of this year in our two REVIVE Phase 3
clinical trials in ABSSSI. This is a significant milestone for the
company and we expect the data read-out from these two trials in
the second half of 2017. We are encouraged to see that patient
enrollment to date is ahead of our projections," commented Dr.
Graham Lumsden, Motif Bio's Chief Executive Officer. "We believe
that iclaprim, a novel antibiotic with an under-utilized mechanism
of action, if approved, could offer advantages compared to the
current standard of care for high-risk, seriously ill patients
hospitalised with ABSSSI and who also have renal impairment or
diabetes," added Dr. Lumsden.
A registration statement relating to these securities has been
filed with the SEC, but has not yet become effective. These
securities may not be sold, nor may offers to buy these securities
be accepted, prior to the time the registration statement becomes
effective. This press release shall not constitute an offer to sell
or a solicitation of an offer to buy any securities, nor shall
there be any sale of these securities in any state or jurisdiction
in which such offer, solicitation or sale would be unlawful prior
to registration or qualification under the securities laws of any
such state or jurisdiction.
For further information please contact:
Motif Bio plc info@motifbio.com
Graham Lumsden (Chief Executive
Officer)
Zeus Capital Limited (NOMAD
& BROKER) +44 (0)20 3829 5000
Phil Walker/Giles Balleny
Dominic Wilson
Northland Capital Partners
Limited (BROKER) +44 (0)203 861 6625
Patrick Claridge/ David Hignell
John Howes/ Rob Rees (Broking)
Walbrook PR Ltd. (FINANCIAL +44 (0) 20 7933 8780 or motifbio@walbrookpr.com
PR & IR)
Paul McManus Mob: +44 (0)7980 541 893
Mike Wort Mob: +44 (0)7900 608 002
MC Services AG (EUROPEAN IR) +49 (0)89 210 2280
Raimund Gabriel
About Motif Bio
Motif Bio plc is a clinical stage biopharmaceutical company
engaged in the research and development of novel antibiotics
designed to be effective against serious and life-threatening
infections in hospitalised patients caused by multi-drug resistant
bacteria. The discovery of new antibiotics has not kept pace with
the increasing incidence of resistant, difficult-to-treat bacteria.
One of the biggest threats of antibiotic resistance is from MRSA
(methicillin resistant Staphylococcus aureus), a leading cause of
hospital-acquired infections and a growing cause of infections in
healthy people in the general community. In 2013, the Centers of
Disease Control (CDC) reported that at least two million people
became infected with antibiotic-resistant bacteria and at least
23,000 Americans died as a direct result of these infections. Our
lead product candidate, iclaprim, is being developed for the
treatment of acute bacterial skin and skin structure infections
(ABSSSI) and hospital acquired bacterial pneumonia (HABP),
including ventilator associated bacterial pneumonia (VABP),
infections which are often caused by MRSA. We are currently
enrolling and dosing patients in two global Phase 3 clinical trials
with an IV formulation of iclaprim, for the treatment of
ABSSSI.
Forward-looking statements
This news release contains forward-looking statements that
reflect Motif Bio's current expectations regarding future events,
including statements regarding financial performance, the timing of
clinical trials, the relevance of Motif Bio's product candidates,
and the clinical benefits, safety profile, and commercial potential
of iclaprim. Forward-looking statements involve risks and
uncertainties. Actual events could differ materially from those
projected herein and depend on a number of factors, including
(inter alia), the success of Motif Bio's clinical development
strategies, the successful and timely completion of uncertainties
related to the regulatory process, and the acceptance of iclaprim
and other products by consumer and medical professionals. A further
list and description of risks and uncertainties associated with an
investment in Motif Bio can be found in Motif Bio's filings with
the U.S. Securities and Exchange Commission. Existing and
prospective investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof. Motif Bio undertakes no obligation to update or revise the
information contained in this press release, whether as a result of
new information, future events or circumstances or otherwise.
Motif Bio Overview
We are a clinical stage biopharmaceutical company engaged in the
research and development of novel antibiotics designed to be
effective against serious and life-threatening infections in
hospitalised patients caused by multi-drug resistant bacteria. The
discovery of new antibiotics has not kept pace with the increasing
incidence of resistant, difficult-to-treat bacteria. One of the
biggest threats of antibiotic resistance is from Methicillin
Resistant Staphylococcus aureus (MRSA), a leading cause of
hospital-acquired infections and a growing cause of infections in
healthy people in the general community. In 2013, the Centers of
Disease Control (CDC) reported that at least two million people
became infected with antibiotic-resistant bacteria and at least
23,000 Americans died as a direct result of these infections. Our
lead product candidate, iclaprim, is being developed for the
treatment of ABSSSI and HABP, including VABP, infections which are
often caused by MRSA. We are enrolling and dosing patients in our
two REVIVE Phase 3 clinical trials with an IV, formulation of
iclaprim,
for the treatment of ABSSSI.
Iclaprim is a novel diaminopyrimidine antibiotic that inhibits
an essential bacterial enzyme called "dihydrofolate reductase"
(DHFR). Diaminopyrimidines are a class of chemical compounds that
inhibit different enzymes in the production of tetrahydrofolate, a
form of folic acid, which is required for the production of
bacterial DNA and RNA. The inhibition of DHFR represents a
differentiated and under-utilised mechanism of action compared with
other antibiotics. We acquired iclaprim from Nuprim Inc., or
Nuprim, following the completion of our merger with the company on
1 2015. Arpida AG, or Arpida, one of the previous owners of
iclaprim, completed a comprehensive development programme for
iclaprim, including two Phase 3 trials in complicated skin and skin
structure infections (cSSSI). Iclaprim has been administered to
more than 600 patients and healthy volunteers in Phase 1, 2 and 3
clinical trials and in contrast to vancomycin, a standard of care
antibiotic in hospitalised patients with "Gram-positive"
infections, no evidence of nephrotoxicity (i.e., damage to the
kidneys caused by exposure to a toxic chemical, toxin or
medication) has been observed with iclaprim, and, therefore,
therapeutic monitoring or dosage adjustment in patients with renal
impairment is not required with iclaprim. "Gram-positive" or
"Gram-negative" refer to how bacteria react to the Gram stain test
based on the outer casing of the bacteria, and the bacteria's cell
wall structure. Each type of bacteria may be associated with
different diseases. Iclaprim has also demonstrated rapid
bactericidal activity and a low propensity for resistance
development in vitro.
We believe that iclaprim is an attractive potential candidate
for use as a first-line empiric monotherapy, the initial therapy
administered prior to the identification of the pathogen, in
severely ill patients who are hospitalised with ABSSSI caused by
MRSA and have comorbidities, or also suffer from other health
issues, such as diabetes or renal impairment. Renal impairment
affects up to an estimated 936,000 of the approximately 3.6 million
patients hospitalised with ABSSSI annually in the United States. On
2 March 2016, we announced the dosing of the first patient in our
two REVIVE (Randomized Evaluation intraVenous Iclaprim Vancomycin
trEatment) Phase 3 clinical trials in ABSSSI. Data from the two
trials are expected in the second half of 2017. If successful, we
believe the data from the two REVIVE trials will satisfy the
requirements to submit a New Drug Application (NDA) in the United
States and a Marketing Authorisation Application (MAA) in Europe to
obtain marketing approval for an IV formulation of iclaprim in the
treatment of ABSSSI caused by Gram-positive pathogens, including
resistant strains such as MRSA. If approved, we believe that
iclaprim can become a valuable addition to the formulary of
life-saving antibiotics used by hospital physicians.
We plan to complete preparations for our INSPIRE (Iclaprim for
NoSocomial PneumonIa gRam- positive pathogEns) Phase 3 clinical
trial with iclaprim in patients with HABP, including patients with
VABP, by the end of 2016. Subject to the availability of funding,
we would look to start dosing patients thereafter. There are
approximately 1.4 million patients hospitalised annually in the
United States with HABP, including patients with VABP. We believe
that iclaprim is well suited for use as a first-line empiric
therapy for patients with HABP, including patients with VABP, based
on data from a Phase 2 clinical trial, which demonstrated
iclaprim's efficacy in this patient population. Additionally, in a
Phase 1 healthy volunteer trial, concentrations of iclaprim at the
site of infection in the lungs were considerably higher than
concentrations in plasma.
In July 2015, the FDA, designated the IV formulation of iclaprim
as a Qualified Infectious Disease Product (QIDP) for ABSSSI and
HABP. QIDP status grants iclaprim regulatory Fast Track
designation, Priority Review and, if approved, a five-year
extension to the statutory market exclusivity period in the United
States, resulting in 10 years of market exclusivity from the date
of approval. If approved by the European Medicines Agency, or EMA,
we expect that iclaprim will qualify for eight years of data
exclusivity and an additional two years of market exclusivity in
the EU. If approved by the Pharmaceuticals and Medical Devices
Agency (PDMA) in Japan, we expect that iclaprim will qualify for
eight years of data exclusivity (which may be extended to ten years
for orphan or pediatric indications) and an additional two years of
market exclusivity in Japan.
We believe that iclaprim is well suited for use as a first-line
empiric monotherapy in patients with ABSSSI who are comorbid with
renal impairment for the following reasons:
-- iclaprim achieved high cure rates against the common
Gram-positive causal organisms, including MRSA, in patients with
cSSSI in completed Phase 2 and 3 trials;
-- iclaprim exhibited safety and tolerability comparable to
vancomycin and linezolid in over 600 patients and healthy
volunteers in completed Phase 1, 2 and 3 trials;
-- iclaprim has demonstrated no nephrotoxicity, eliminating the
requirement for therapeutic monitoring or dosage adjustment in
renally impaired patients;
-- no cases of symptomatic hypoglycemia have been reported in
iclaprim-treated patients with diabetes mellitus receiving insulin
or oral hypoglycemic agents;
-- iclaprim has demonstrated no clinically significant drug-drug
interactions (DDIs) with selective serotonin reuptake inhibitors
(SSRIs), or vasopressors; and
-- no cases of myopathy or rhabdomyolysis have been reported in
iclaprim-treated patients who received recent prior or concomitant
therapy with an HMG-CoA reductase inhibitor or in whom elevations
in CPK occur during treatment.
We also believe that iclaprim is well positioned as a first-line
empiric therapy for patients with HABP, including patients with
VABP, for the following reasons:
-- iclaprim achieved high cure rates against the common
Gram-positive causal organisms, including MRSA, in patients with
HABP, including patients with VABP, in a completed Phase 2
trial;
-- iclaprim has demonstrated high and sustained concentrations
in epithelial lining fluid (ELF) and alveolar macrophages which
were 20-30 times the plasma concentration, respectively, throughout
an entire 7-hour sampling period; and
-- iclaprim has demonstrated no clinically significant DDIs with
commonly used antibiotics in patients with combined Gram-positive
and Gram-negative infections.
In addition to our clinical programmes, we have a preclinical
development programme underway to identify a formulation of
iclaprim suitable for adolescent and pediatric patients. We are
also developing IV and oral formulations of MTF-101, a
diaminopyrimidine that may be suitable for testing in clinical
trials to demonstrate safety and efficacy in patients with
osteomyelitis and patients with prosthetic joint infections.
Management's Discussion and Analysis of Financial Condition and
Results of Operations
Overview
We are currently enrolling and dosing patients in our two REVIVE
global Phase 3 clinical trials with an IV formulation of iclaprim,
for the treatment of ABSSSI. Data from the two trials are expected
in the second half of 2017. If successful, we expect the data from
the two REVIVE trials will satisfy the requirements to submit an
NDA in the U.S. and a MAA in Europe to obtain marketing approval
for an IV formulation of iclaprim in the treatment of ABSSSI caused
by Gram-positive pathogens, including resistant strains such as
MRSA. If approved, we believe that iclaprim can become a valuable
addition to the formulary of life-saving antibiotics used by
hospital physicians.
Based on our current plans, we do not expect to generate
significant revenue unless and until we obtain marketing approval
for, and commercialise, iclaprim. We do not expect to obtain
marketing approval before 2018, if at all. Accordingly, we will
need to obtain additional funding in connection with our continuing
operations, including completion of the two REVIVE trials and our
plans to conduct our INSPIRE Phase 3 clinical trial of iclaprim in
HABP, including VABP, patients. Adequate additional financing may
not be available to us on acceptable terms, or at all. If we are
unable to raise capital when needed or on attractive terms, we
could be forced to delay, reduce or eliminate our research and
development programs or any future commercialisation effort.
We expect to continue to incur significant expenses and
increasing operating losses for at least the next several years. We
expect our expenses to increase substantially in connection with
our ongoing activities, particularly as we continue the development
of and seek marketing approval for iclaprim and, possibly, other
product candidates and continue our research activities. Our
expenses will increase if we suffer any delays in our Phase 3
clinical programmes for iclaprim. If we obtain marketing approval
for iclaprim or any other product candidate that we develop, we
expect to incur significant commercialisation expenses related to
product sales, marketing, distribution and manufacturing.
Furthermore, as previously announced on July 13, 2016, we have
filed a registration statement on Form F-1 with the U.S. Securities
and Exchange Commission relating to a proposed U.S. public offering
of American Depositary Shares; if such offering were consummated,
we expect to incur additional costs associated with operating as a
public company in the United States.
Financial Operations Overview
The following discussion sets forth certain components of our
statements of operations as well as factors that impact those
items.
Revenues
To date, we have not generated any revenues from product sales
and we do not expect to recognise any revenue from the sale of
products, even if approved, for the next few years. Our success
depends primarily on the successful development and regulatory
approval of our product candidates and our ability to finance
operations. If our development efforts result in clinical success
and regulatory approval, or we enter into collaboration agreements
with third parties for our product candidates, we may generate
revenue from those product candidates. Our ability to generate
product revenue and become profitable depends upon our ability to
obtain regulatory approval for and to successfully commercialise
our product candidates.
General and Administrative Expenses
General and administrative expenses include personnel costs,
costs for outside professional services and other allocated
expenses. Personnel costs consist of salaries, bonuses, benefits,
travel and share-based compensation. Outside professional services
consist of legal, accounting and audit services, commercial
evaluation and strategy services, and other consulting services. We
expect general and administrative expenses to increase in the near
future with the expansion of our staff and management team to
include new personnel responsible for finance, legal, information
technology and later, sales and business development functions. In
the event the US offering were consummated, we also expect to incur
additional general and administrative costs as a result of
operating as a US public company, including expenses related to
compliance with the rules and regulations of the SEC and those of
any national securities exchange on which our securities are
traded, additional insurance expense, investor relations activities
and other administrative and professional services. We also expect
to incur additional expenses related to in-licenses, acquisitions
or similar transactions that we may pursue as part of our strategy,
including legal, accounting and audit services and other consulting
fees.
Research and Development Expenses
Our research and development expenses consist primarily of costs
incurred in connection with the development of our product
candidates, including:
-- personnel-related costs, such as salaries, bonuses, benefits,
travel and other related expenses, including share-based
compensation;
-- expenses incurred under our agreements with CROs, clinical
sites, contract laboratories, medical institutions and consultants
that plan and conduct our preclinical studies and clinical trials,
including, in the case of consultants, share-based
compensation;
-- costs associated with regulatory filings;
-- upfront and milestone payments under agreements with third parties;
-- costs of acquiring preclinical study and clinical trial
materials, and costs associated with preclinical development
formulation and process development; and
-- depreciation, maintenance and other facility-related expenses.
To date, we have expensed all research and development costs as
incurred. Clinical development expenses for our product candidates
are a significant component of our current research and development
expenses as we progress our product candidates into and through
clinical trials. Product candidates in later stage clinical
development generally have higher research and development costs
than those in earlier stages of development, primarily due to
increased size and duration of the clinical trials. We recognise
costs for each grant project, preclinical study or clinical trial
that we conduct based on our evaluation of the progress to
completion, using information and data provided to us by our
research and development vendors and clinical sites.
If we meet the following conditions, we would be able to
capitalise expenditures on drug development activities:
-- 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. At this time we do
not meet all conditions and therefore, development costs are
recorded as expense in the period in which the cost is
incurred.
We incurred research and development expenses of US$12.0 million
and US$0.6 million for the six months ended June 30, 2016 and 2015,
respectively; US$6.2 million and US$0.5 million for the three
months ended June 3, 2016 and 2015, respectively; and US$4.7
million and US$0.0 million for the years ended December 31, 2015
and 2014, respectively. Our activities in 2014 were comprised of
building medicinal chemistry plans, seeking new capital, pursuing
additional in-licensing opportunities and searching for assets and
optimisation activities.
We expect our research and development expenses to increase over
the next few years as a result of our ongoing and anticipated Phase
3 clinical trials and as we prepare for commercial launch of our
products, if approved. The process of conducting the necessary
clinical research to obtain regulatory approval of a product
candidate is costly and time consuming. We will require additional
funding to fund our continuing operations, including our plans to
conduct our INSPIRE Phase 3 clinical trial of iclaprim in HABP,
including VABP, patients. The probability that any of our product
candidates receives regulatory approval and eventually is able to
generate revenue depends on a variety of factors, including the
quality of our product candidates, early clinical data, investment
in our clinical programme, competition, manufacturing capability
and commercial viability. As a result of these uncertainties, we
are unable to determine the duration and completion costs of our
research and development projects or if, when and to what extent we
will generate revenue from the commercialisation and sale of any of
our product candidates, if approved. We may never succeed in
achieving regulatory approval for any of our product
candidates.
We do not allocate personnel-related research and development
costs, including share-based compensation or other indirect costs,
to specific programs, as they are deployed across multiple projects
under development.
Other Income (Expense), Net
Other income (expense), net, consists of interest income
generated from our cash and cash equivalents and foreign exchange
gains and losses.
Items included in our audited consolidated financial statements
are measured using the currency of the primary economic environment
in which we operate ("the functional currency"). The audited
consolidated financial statements are presented in United States
Dollars (US$), which is our functional and presentation
currency.
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.
Historically, our cash and cash equivalents have been held
primarily in US dollars, in the United Kingdom and most of our
expenses have been US dollar-denominated.
Comparison of the three months ended 30 June 2016 and 30 June
2015
General and Administrative Expense
General and administrative expenses increased by US$0.4 million,
or 50%, to US$1.1 million in the three months ended 30 June 2016
from US$ 0.8 million in the three months ended 30 June 2015. This
increase was primarily attributable to (i) an increase in personnel
related expenses; and (ii) increases in the costs of outside
professional services, including commercial evaluation and strategy
services, investor relations and other consulting services.
Research and Development Expense
Research and development expenses increased by US$5.7 million to
US$6.2 million in the three months ended 30 June 2016 from US$0.5
million in three months ended 30 June 2015. This increase was
primarily attributable to the commencement of iclaprim clinical
development. For the three months ended 30 June 2016, US$5.1
million was spent in relation to contract research organisation
expenses, US$0.5 million in relation to clinical operations and
US$0.6 million in relation to chemistry and manufacturing
development and other non-clinical development.
Comparison of the six months ended 30 June 2016 and 30 June
2015
General and Administrative Expense
General and administrative expenses increased by US$0.8 million,
or 78%, to US$1.9 million in the six months ended 30 June 2016 from
US$ 1.1 million in the six months ended 30 June 2015. This increase
was primarily attributable to (i) an increase in personnel related
expenses; (ii) the costs associated with being a public company in
the United Kingdom; and (iii) increases in the costs of outside
professional services, including commercial evaluation and strategy
services, investor relations, and other consulting services.
Research and Development Expense
Research and development expenses increased by US$11.4 million
to US$12.0 million in the six months ended 30 June 2016 from US$0.6
million in six months ended 30 June 2015. This increase was
primarily attributable to the commencement of iclaprim clinical
development. For the six months ended 30 June 2016, US$10.1 million
was spent in relation to contract research organisation expenses,
US$1.0 million in relation to clinical operations and US$0.9
million in relation to chemistry and manufacturing development and
other non-clinical development.
Net Foreign Exchange Gain/ (loss)
The net foreign exchange (loss) for the six months ended 30 June
2016 was US$198,000, as compared to a gain of US$968 in the six
months ended 30 June 2015. In both periods the gain/loss recognised
relates to the re-measurement of the Company's Sterling denominated
cash deposits to US dollars at the closing US dollar to Sterling
exchange rate. Sterling denominated cash deposits totaled
GBP1,120,530 at 30 June 2016 and GBP1,774,741 at 31
December2015.
Liquidity and Capital Resources
At 30 June 2016 and 31 December 2015, we had cash and cash
equivalents of approximately US$19.5 million and US$28.6 million,
respectively. We do not expect to generate significant revenue from
product sales unless and until we obtain regulatory approval for
and commercialise our current or any future product candidates. We
anticipate that we will continue to generate losses for the
foreseeable future, and we expect our losses to increase as we
continue the development of and seek regulatory approvals for our
product candidates and begin to commercialise any approved
products. We are subject to all of the risks applicable to the
development of new products, and we may encounter unforeseen
expenses, difficulties, complications, delays and other unknown
factors that may harm our business.
Our operations have been financed primarily by net proceeds from
the issuance of ordinary shares on AIM and convertible promissory
notes issued to related parties. Our primary uses of capital are,
and we expect will continue, at least in the short term, to be,
third-party expenses associated with the planning and conduct of
preclinical and clinical trials, costs of process development
services and manufacturing of our product candidates, and
compensation-related expenses. We also expect our cash needs to
increase to fund potential in-licenses, acquisitions or similar
transactions as we pursue our strategy.
Cash used to fund operating expenses is affected by the timing
of when we pay expenses, as reflected in the change in our
outstanding accounts payable and accrued expenses.
Our future funding requirements will depend on many factors,
including the following:
-- the scope, rate of progress, results and cost of our
preclinical studies and clinical trials and other related
activities;
-- the cost of formulation, development, manufacturing of
clinical supplies and establishing commercial supplies of our
product candidates and any other product candidates that we may
develop, in-license or acquire;
-- the cost, timing and outcomes of pursuing regulatory approvals;
-- the cost and timing of establishing administrative, sales,
marketing and distribution capabilities;
-- the terms and timing of any collaborative, licensing and
other arrangements that we may establish, including any required
milestone and royalty payments thereunder; and
-- the emergence of competing technologies and their achieving
commercial success before we do or other adverse market
developments.
We expect to continue to incur losses. Our ability to achieve
and maintain profitability depends upon the successful development,
regulatory approval and commercialisation of our product candidates
and achieving a level of revenues adequate to support our cost
structure. We may never achieve profitability, and unless and until
we do, we will continue to need to raise additional capital. If we
need to raise additional capital to fund our operations and
complete our ongoing and planned clinical trials, funding may not
be available to us on acceptable terms, or at all.
We plan to continue to fund our operations and capital funding
needs through equity or debt financings. The sale of additional
equity would result in additional dilution to our shareholders. The
incurrence of debt financing would result in debt service
obligations and the instruments governing such debt could provide
for operating and financing covenants that would restrict our
operations. If we are not able to secure adequate additional
funding, we may be forced to make reductions in spending, extend
payment terms with suppliers, sell assets where possible or suspend
or curtail planned programs. In addition, lack of funding would
limit any strategic initiatives to in-license or acquire additional
product candidates or programs.
Cash Flows
Six months ended
-------------------------------
June 30, 2016 30 June, 2015
--------------- --------------
US $'000 US $'000
Net cash (used in) / provided by:
Operating activities (8,889) (1,152)
Financing activities (1) 3,930
Effect of exchange rate changes on
cash and cash equivalents (198) 1
(9,088) 2,779
=============== ==============
Operating Activities
Net cash used in operating activities was US$8.9 million in the
six months ended June 30, 2016, which reflects the continuation of
the clinical development of iclaprim. Net cash used in operating
activities was US$1.2 million for the six months ended June 30,
2015, reflecting the commencement of clinical development of
iclaprim.
Financing Activities
Net cash used in financing activities amounted to $0 in the six
months ended June 30, 2016. Net cash provided by financing
activities was US$3.9 million in the six months ended June 30, 2015
resulting from the issuance of promissory notes, as well as the
Company's initial public offering on AIM, pursuant to which we
issued 14,186,140 of our ordinary shares at a price of GBP0.20
(US$0.30) per share.
Trade and other payables
Current trade and other payables at June 30, 2016 increased by
US$5.3 million to US$6.3 million from US$1.0 million at December
31, 2015. This increase reflects an increase in trade payables and
accruals as a result of the continued expansion of Motif funded
clinical trials.
Risks Associated With Our Business
Our business is subject to a number of risks of which you should
be aware before making an investment decision. These risks include,
but are not limited to, the following:
-- We are a development-stage biopharmaceutical company that has
not yet demonstrated an ability to complete a large-scale, pivotal
clinical trial successfully, obtain regulatory approval or
manufacture and commercialise a product candidate. We have a
limited operating history on which to assess our business, have
incurred significant losses over the last several years, and
anticipate that we will continue to incur losses until after
iclaprim receives approval for marketing.
-- We have never generated any revenue from product sales and
may never be profitable. Our net loss for the six months ended June
30, 2016 was US$14.0 million, and as of June 30, 2016, we had an
accumulated deficit of US$34.5 million.
-- We will need substantial additional funding before we can
expect to complete the development of our product candidates and
become profitable from sales of our approved products if any.
-- We depend entirely on the success of a limited number of
product candidates, which are still in preclinical or clinical
development. If we do not obtain regulatory approval for, and
successfully commercialise, one or more of our product candidates,
or we experience significant delays in doing so, we may never
become profitable.
-- Clinical trials are very expensive, time consuming, difficult
to design and implement, and involve uncertain outcomes.
Furthermore, results of earlier studies and trials may not be
predictive of results of future trials.
-- Even if one or more of our product candidates obtains
regulatory approval, we will be subject to ongoing obligations and
continued regulatory requirements, which may result in significant
additional expense.
-- We have never commercialised a product candidate and we may
lack the necessary expertise, personnel and resources to
successfully commercialise any of our products that receive
regulatory approval on our own or together with suitable
partners.
-- If we acquire other businesses or in-license or acquire other
product candidates and are unable to integrate them successfully,
our financial performance could suffer.
-- We operate in a highly competitive and rapidly changing
industry, which may result in our competitors discovering,
developing or commercialising competing products before or more
successfully than we do, or our entering a market in which a
competitor has commercialised an established competing product, and
we may not be successful in competing with them.
-- We may not be successful in executing our growth strategy or
our growth strategy may not deliver the anticipated results.
-- We are highly dependent on our key personnel, including our
chief executive officer and chief financial officer, and on our
ability to recruit, retain and motivate additional qualified
personnel.
-- If we or our licensors are unable to obtain and maintain
effective IP rights for our technologies, product candidates or any
future product candidates, or if the scope of the IP rights
obtained is not sufficiently broad, we may not be able to compete
effectively in our markets.
The financial statements of the Company are presented in the
currency of the primary economic environment in which it operates
(its functional currency). For the purpose of the consolidated
financial statements, the results and financial position of the
Company are expressed in US. Dollars. However, during the reporting
period the Company had exposure to Sterling and Euros.
The Company requires significant additional funds in order to
complete its two Phase 3 REVIVE clinical trials and to commence the
HABP phase 3 clinical trial. If such additional funding were not
forthcoming in the near term, the Company has the option under its
contract with the Clinical Research Organisation to reduce or
suspend clinical trial activities until appropriate levels of
funding can be obtained, and also the ability to delay commencement
of the HABP trial. The directors continually monitor the cash
requirements of the group and will leave sufficient funds to
continue as a going concern for at least 12 months from the date of
these interim financial statements by reducing or suspending
clinical trial activity in the absence of further funding.
Motif Bio plc
Unaudited interim condensed consolidated statements
of loss and comprehensive loss
For the three months For the six months
ended ended
June 30, June 30,
------------------------------------------ ---------------------------------------
Note 2016 2015 2016 2015
---------- ---------------------- ----------------- ------------------- -----------------
US $ US $ US $ US $
Operations
General and administrative
expenses 3 (1,143,957) (763,300) (1,927,434) (1,083,085)
Research and development
expenses 3 (6,234,038) (512,730) (12,026,721) (639,101)
Gains on settlement of
contract
disputes 3 - 5,027 83,320 5,027
Operating loss (7,377,995) (1,271,003) (13,870,835) (1,717,159)
Interest income 4 20,434 107 42,872 260
Interest expense 4 (62,829) (21,601) (125,738) (141,177)
Net foreign exchange
(losses)/gains 4 (185,818) - (197,814) 968
Loss before income taxes (7,606,208) (1,292,497) (14,151,515) (1,857,108)
Income tax 5 - - - -
Net loss for the period (7,606,208) (1,292,497) (14,151,515) (1,857,108)
---------------------- ----------------- ------------------- -----------------
Total comprehensive loss
for
the period (7,606,208) (1,292,497) (14,151,515) (1,857,108)
====================== ================= =================== =================
Loss per share for loss from
operations attributable
to the ordinary equity
holders
of the company: 6
Basic and diluted loss per
share (0.07) (0.02) (0.13) (0.04)
---------------------- ----------------- ------------------- -----------------
The accompanying footnotes are an integral part of these
condensed consolidated interim financial statements.
Motif Bio plc
Unaudited interim condensed consolidated statements
of financial position
At June 30, 2016 and December 31,
2015
At June 30, At December 31,
Note 2016 2015
----- ----------------------- -------------------------------
US $ US $
ASSETS
Non-current assets
Intangible assets 6,195,748 6,195,748
Total non-current assets 6,195,748 6,195,748
----------------------- -------------------------------
Current assets
Prepaid expenses and other receivables 7 110,857 167,657
Cash 19,507,214 28,594,347
Total current assets 19,618,071 28,762,004
----------------------- -------------------------------
Total assets 25,813,819 34,957,752
======================= ===============================
LIABILITIES
Non-current liabilities
Payable on completion of clinical
trial 500,000 500,000
Total non-current liabilities 500,000 500,000
----------------------- -------------------------------
Current liabilities
Trade and other payables 8 6,319,715 987,083
Other interest-bearing loans and
borrowings 9 3,872,929 3,747,961
Total current liabilities 10,192,644 4,735,044
----------------------- -------------------------------
Total liabilities 10,692,644 5,235,044
======================= ===============================
Net assets 15,121,175 29,722,708
======================= ===============================
EQUITY
Share capital 10 1,645,291 1,645,291
Share premium 10 38,076,964 38,534,280
Group reorganization reserve 10 9,938,362 9,938,362
Accumulated deficit 10 (34,539,442) (20,395,225)
Total equity 15,121,175 29,722,708
======================= ===============================
The accompanying footnotes are an integral part of these
condensed consolidated interim financial statements.
Motif Bio plc
Unaudited interim condensed consolidated statements
of changes in equity
For the six months ended June
30, 2016 and 2015
Group
Share Share reorganization Accumulated
capital premium reserve deficit Total
US $ US $ US $ US $ US $
-------------------- ------------------- ------------------------ --------------------- ----------------
Balance at December 31,
2014 1,110 3,964,455 - (14,884,023) (10,918,458)
Loss for the period - - - (1,857,108) (1,857,108)
-------------------- ------------------- ------------------------ --------------------- ----------------
Total comprehensive
loss
for the period - - - (1,857,108) (1,857,108)
Conversion of
promissory
notes 3,573 6,275,213 - - 6,278,786
Group reorganization 539,267 (10,239,668) 9,938,362 - 237,961
Issue of share capital 409,625 7,711,420 - - 8,121,045
Cost of issuance - (942,164) - - (942,164)
Issue of warrants to
acquire
assets - - - 2,340,373 2,340,373
Share-based payments - - - 398,880 398,880
-------------------- ------------------- ------------------------ --------------------- ----------------
Balance at June 30,
2015 953,575 6,769,256 9,938,362 (14,001,878) 3,659,315
==================== =================== ======================== ===================== ================
Balance at December 31,
2015 1,645,291 38,534,280 9,938,362 (20,395,225) 29,722,708
Loss for the period - - - (14,151,515) (14,151,515)
-------------------- ------------------- ------------------------ --------------------- ----------------
Total comprehensive
loss
for the period - - - (14,151,515) (14,151,515)
Cost of issuance - (457,316) - - (457,316)
Share-based payments - - - 7,298 7,298
-------------------- ------------------- ------------------------ --------------------- ----------------
Balance at June 30,
2016 1,645,291 38,076,964 9,938,362 (34,539,442) 15,121,175
==================== =================== ======================== ===================== ================
The accompanying footnotes are an integral part of these
condensed consolidated interim financial statements.
The conversion of promissory notes in 2015 is the settlement of
loan notes held by Amphion Innovations plc in exchange for share
capital. The remaining entries through equity in 2015 are a result
of the group reorganization and AIM listing. Further details of
each can be found in the 2015 year-end financial statements.
Motif Bio plc
Unaudited interim condensed consolidated statements
of cash flows
For the six months June 30, 2016 and
2015
Six months ended
June 30,
---------------------------------------------------------
2016 2015
---------------------------- ---------------------------
US $ US $
Operating activities
Operating loss for the period (13,870,835) (1,717,159)
Adjustments to reconcile net loss to
net cash used in activities:
Share-based payments 7,298 398,880
Gains on settlement of contract disputes (83,320) (5,027)
Interest received 42,872 260
Changes in operating assets and liabilities:
Prepaid expenses, notes receivable and
accounts receivable 56,799 (47,222)
Accounts payable and other accrued liabilities 4,958,637 218,608
---------------------------- ---------------------------
Net cash used in operating activities (8,888,549) (1,151,660)
---------------------------- ---------------------------
Financing activities
Proceeds from issue of promissory notes - 704,210
Proceeds from issue of share capital - 4,309,576
Costs of issuance - (942,164)
Interest paid (770) (141,177)
---------------------------- ---------------------------
Net cash (used in) provided by financing
activities (770) 3,930,445
---------------------------- ---------------------------
Net change in cash (8,889,319) 2,778,785
Cash beginning of the period 28,594,347 3,281
Effect of foreign exchange rate changes (197,814) 968
---------------------------- ---------------------------
Cash, end of the period 19,507,214 2,783,034
============================ ===========================
The accompanying footnotes are an integral part of these
condensed consolidated interim financial statements.
1. General information and basis of preparation
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.
On April 1, 2015 Motif Bio Limited was re-registered as a public
company limited by shares and changed its name to Motif Bio plc. On
the same date, Motif BioSciences Inc. became a wholly-owned
subsidiary of the Company by way of a group reorganisation by plan
of merger. Therefore, Motif BioSciences Inc. is considered the
predecessor of the Company prior to the reorganisation.
These interim condensed consolidated financial statements at
June 30, 2016 together with the notes thereto (the "Interim
Condensed Consolidated Financial Statements") of Motif Bio Plc (the
"Company" and together with its subsidiaries the "Group") were
approved for issuance by the Board of Directors on August 15, 2016,
and have been prepared in accordance with IAS 34 - "Interim
financial reporting". The interim condensed consolidated financial
statements do not include all disclosures required for a full
presentation and do not constitute statutory financial statements.
Management does believe, however, that the interim condensed
consolidated financial statements do provide a fair statement of
the financial information. The audited Motif Bio plc annual
consolidated financial statements for the preceding year have been
filed with Companies House.
The Interim Condensed Consolidated Financial Statements should
be read in conjunction with the Motif Bio Plc annual consolidated
financial statements for the years ended December 31, 2015 and
2014, which have been prepared in conformity with International
Financial Reporting Standards as issued by the International
Accounting Standards Board and in conformity with International
Financial Reporting Standards as adopted by the European Union
("IFRS").
The preparation of financial statements in conformity with IFRS
requires the use of estimates and assumptions that affect the
reported amounts of assets and liabilities at the date of the
financial information and the reported amounts of revenue and
expenses during the period. Although these estimates are based on
management's best knowledge of the amount, event or actions, actual
results ultimately may differ from those estimates. Reference
should be made to the section "Critical accounting estimates and
judgements" in the Annual Consolidated Financial Statements for the
years ended December 31, 2015 and 2014, for a detailed description
of the more significant valuation procedures used by the Group. The
accounting policies adopted in the preparation of these financial
statements are consistent with those presented in the prior period
financial statements. These financial statements have been reviewed
and not audited.
The chief operating decision-maker is considered to be the Board
of Directors of Motif Bio plc. The chief operating decision maker
allocates resources and assesses performance of the business and
other activities at the operating segment level. In addition, they
review the interim condensed consolidated financial statements.
The chief operating decision-maker has determined that the Group
has one operating segment-the development and commercialization of
pharmaceutical formulations. All activities take place in the
United States.
2. New standards and amendments
a. New standards and amendments effective from January 1, 2016
There are no new standards and amendments that have been applied
from January 1, 2016, which have had an impact on the Group's
financial statements.
b. New standards and amendments not yet effective
Certain new accounting standards and interpretations have been
published that are not mandatory for the reporting periods covered
by these unaudited interim condensed consolidated financial
statements and have not been early adopted by the Group.
The expected effective date of IFRS 9-"Financial Instruments"
and IFRS 15-"Revenue from Contracts with Customers" is January 1,
2018 and for IFRS 16-"Leases", is January 1, 2019. Management has
not yet assessed the potential impact of these new standards. These
changes could have a substantial impact on the Group's financial
statements in the coming years.
3. Breakdown of expenses by nature
Three months Three months Six months Six months
ended ended ended ended
June 30, June 30, June 30, June 30,
2016 2015 2016 2015
---------------------- ------------------ ------------- --------------
US $ US $ US $ US $
General and administrative
expenses
Employee benefits expenses 238,562 121,150 422,667 151,150
Directors' fees 111,317 75,200 217,914 75,200
Advisory fees 30,000 45,000 60,000 105,000
Legal and professional
fees 672,530 424,248 1,044,282 588,737
Other expenses 91,548 97,702 182,571 162,998
1,143,957 763,300 1,927,434 1,083,085
---------------------- ------------------ ------------- --------------
Research and developments
costs 6,234,038 512,730 12,026,721 639,101
---------------------- ------------------ ------------- --------------
Gains on settlement of
contract disputes - (5,027) (83,320) (5,027)
---------------------- ------------------ ------------- --------------
The increase in research and development costs were primarily
attributed to the commencement of iclaprim clinical development in
early 2016. The trial has continued to progress in Q2 2016 with
further costs incurred as patients are enrolled.
The increase in legal and professional fees is primarily
attributed to the additional legal and professional costs
associated with being a public company in the UK and advisory costs
incurred in the preparation of the registration statement on Form
F-1 for filing with the U.S. Securities and Exchange Commission
relating to a proposed U.S. public offering of American Depositary
Shares
Gains on settlement of contract disputes relates to the
settlement of a dispute with a contractor in the first quarter of
2016.
4. Finance income and costs
Three months Three months Six months Six months
ended ended ended ended
June 30, June 30, June 30, June 30,
2016 2015 2016 2015
--------------- ------------------ ------------- --------------
US $ US $ US $ US $
Finance income
Interest from financial
assets 20,434 107 42,872 260
20,434 107 42,872 260
--------------- ------------------ ------------- --------------
Finance costs
Interest paid/payable for
financial liabilities (62,829) (21,601) (125,738) (141,177)
(62,829) (21,601) (125,738) (141,177)
--------------- ------------------ ------------- --------------
Interest income and interest payable are recognized in the
income statement as they accrue, using the effective interest
method. Interest income in the six months ended June 30 2016
increased due to an increase in cash balances. Interest expense in
the six months ended June 30, 2016 decreased due to a reduction in
debt outstanding relative to the corresponding period in the prior
year.
Three months Three months Six months Six months
ended ended ended ended
June 30, June 30, June 30, June 30,
2016 2015 2016 2015
------------- ------------- ----------- -----------
US $ US $ US $ US $
Foreign exchange (loss)
/ gain (185,818) - (197,814) 968
(185,818) - (197,814) 986
------------- ------------- ----------- -----------
The increase in exchange losses stems from the translation of a
Sterling bank account subsequent to the perturbation in the
sterling / dollar exchange rate precipitated by the Brexit vote in
the U.K.
5. Income tax expense
Income tax expense is recognized based on management's estimate
of the annual income tax expected for the period.
6. Loss per share
Basic loss per share is calculated by dividing the loss
attributable to equity holders of the Company by the weighted
average number of shares in issue during the period. In accordance
with IAS 33, where the Group has reported a loss for the period,
the shares are anti-dilutive.
Three months Three months Six months Six months
ended ended ended ended
June 30, June 30, June 30, June 30,
2016 2015 2016 2015
-------------- --------------- -------------- ---------------
US $ US $ US $ US $
Loss after taxation (7,606,208) (1,292,497) (14,151,515) (1,857,108)
Basic and diluted weighted
average shares
in issue 108,601,496 63,938,957 108,601,496 50,407,823
--------------- ---------------
Basic and diluted loss per
share (0.07) (0.02) (0.13) (0.04)
============== =============== ============== ===============
The following potentially dilutive securities outstanding at
June 30, 2016 and 2015 have been excluded from the computation of
diluted weighted average shares outstanding, as they would be
antidilutive.
Three months Three months Six months Six months
ended ended ended ended
June 30, June 30, June 30, June 30,
2016 2015 2016 2015
-------------- ------------- ------------- -----------
US $ US $ US $ US $
Convertible promissory notes 14,510,770 14,510,770 14,510,770 14,510,770
Warrants 5,932,675 5,876,907 5,932,675 5,876,907
Share options 7,352,232 6,717,883 7,352,232 6,717,883
27,795,677 27,105,560 27,795,677 27,105,560
============== ============= ============= ===========
7. Prepaid expenses and other receivables
At June 30, At December
2016 31, 2015
------------------------------- -------------------------------
US $ US $
Other receivables and prepayments 110,857 167,657
=============================== ===============================
8. Trade and other payables
At June 30, At December
2016 31, 2015
----------------------------------- ---------------------------------
US $ US $
Trade payables 1,330,070 108,247
Accrued expenses 4,989,624 877,238
Amounts due to shareholders 21 1,598
6,319,715 987,083
=================================== =================================
From December 31, 2015 to June 30, 2016, trade payables and
accrued expenses increased principally as a result of an increase
in the amounts due to a contract research organization
9. Other interest bearing loans and borrowings
At June 30, At December
2016 31, 2015
------------------------------- -------------------------------
US $ US $
Notes payable to shareholders 3,550,786 3,550,786
Accrued interest expense 322,143 197,175
3,872,929 3,747,961
=============================== ===============================
Amounts due to shareholders in respect of accrued interest on
loan notes (see note 11) and other liabilities as follows:
At June 30, At December
2016 31, 2015
------------------------------- --------------------------------
US $ US $
Amounts due to Amphion Innovations
plc 130,205 78,409
Amounts due to Amphion Innovations
US Inc. 183,941 110,769
314,146 189,178
=============================== ================================
The amounts due to Amphion increased due to the accrual of
interest at a rate of 7% per annum for 181 days.
10. Equity
Allotted, called up, and fully paid: Number US $
--------------------------- ------------------------------
In issue at December 31, 2015 108,601,496 1,645,291
In issue at June 30, 2016 108,601,496 1,645,291
Share premium represents the excess over nominal value of the
fair value consideration received for equity shares net of expenses
of the share issue.
Retained deficit represents accumulated losses.
The group reorganisation reserve arose when Motif Bio plc became
the parent of the Group. The transaction, falling as it does
outside the scope of IFRS3, has been accounted for as a group
reorganization and not a business combination. The reorganisation
reserve can be derived by calculating the difference between the
nominal value of the shares in Motif Bio plc issued to the former
shareholders in Motif BioSciences Inc. and the share capital and
share premium of Motif BioSciences Inc. at the date of the
merger.
11. Related party transactions
Transactions with Amphion Innovations plc and Amphion
Innovations US, Inc.
At June 30, 2016 Amphion Innovations plc owned 26.08% of the
issued ordinary shares in Motif Bio plc. In addition, the Amphion
Group has provided funding for the activities of Motif BioSciences
Inc. through the issue of convertible interest bearing loan notes.
Richard Morgan and Robert Bertoldi were directors of both the
Company and Amphion Innovations plc in the period. Transactions
between the Group and the Amphion Group are disclosed below:
At December
At June 30, 2016 31, 2015
------------------------------------ ---------------------------------
US $ US $
Amounts due to Amphion Innovations
US, Inc. 21 1,599
Notes payable to Amphion Innovations
plc 1,471,700 1,471,700
Notes payable to Amphion Innovations
US, Inc. 2,079,086 2,079,086
11. Related party transactions (continued)
Six months ended June 30,
------------------------------------------------------------------
2016 2015
------------------------------- ---------------------------------
US $ US $
Accrued and unpaid interest on
loan notes 314,146 70,136
Interest expense 124,968 141,177
12. Post balance sheet events
In July 2016, Motif Bio plc filed a registration statement on
Form F-1 with the U.S. Securities and Exchange Commission relating
to a proposed U.S. public offering of American Depositary Shares.
The ADSs have been approved for listing on the NASDAQ Global Market
under the ticker symbol "MTFB".
In a referendum held in the United Kingdom on June 23, 2016, a
majority of those voting voted for the United Kingdom to leave the
EU. For now, the United Kingdom remains a member of the EU and
there will not be any immediate change in either EU or U.K. law as
a consequence of the "leave" vote.
The ultimate impact of the "leave" vote will depend on the terms
that are negotiated in relation to the United Kingdom's future
relationship with the EU. Although the timetable for U.K.
withdrawal is not at all clear at this stage, it is likely that the
withdrawal of the United Kingdom from the EU will take at least two
years to be negotiated and conclude. The period of negotiations
will result in continued uncertainty and this, along with any
direct effects of the U.K.'s withdrawal, could adversely affect our
business, business opportunities, results of operations, financial
condition and cash flows.
This information is provided by RNS
The company news service from the London Stock Exchange
END
IR EADPSFDFKEAF
(END) Dow Jones Newswires
August 16, 2016 02:01 ET (06:01 GMT)
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