Summit Therapeutics plc (AIM:SUMM) (NASDAQ:SMMT), the drug
discovery and development company advancing therapies for Duchenne
muscular dystrophy (‘DMD’) and C. difficile infection (‘CDI’),
today reports its financial results for the fourth quarter and
fiscal year ended 31 January 2016.
Mr Glyn Edwards, Chief Executive Officer
of Summit commented: “Summit’s substantial clinical
accomplishments over the past year have contributed to great
momentum in both our DMD and CDI programmes. Notably, the
successful completion of a Phase 1b trial in DMD will enable
ezutromid to advance into a Phase 2 proof of concept trial and a
Phase 2 trial in CDI demonstrated statistical superiority of
ridinilazole over standard of care, positioning ridinilazole as a
highly promising asset in the treatment of CDI. We now look forward
to what could be a pivotal year ahead with the first look at
potential proof of mechanism for ezutromid in DMD boys, and
exploring a potential partnership for ridinilazole.”
HIGHLIGHTS
Utrophin Modulation Programme for DMD
Ezutromid (formerly SMT C1100) Highlights
- Primary objective achieved in Phase 1b clinical trial in DMD
patients with dietary guidance increasing ezutromid absorption to
levels with potential to sustain utrophin production
- PhaseOut DMD Phase 2 clinical trial of ezutromid expected to
enrol first patients in Q2 2016 with reporting of 24 week biopsy
data from initial group of patients expected in January 2017
- Positive interim data reported from Phase 1 clinical trial
testing new formulation of ezutromid
- Strengthening of patent estate protecting ezutromid with grant
of patent in Europe
Utrophin Modulator Pipeline: Future Generation Development
- Achieved milestone in strategic alliance with the University of
Oxford with nomination of two series of future generation utrophin
modulators for progression into lead optimisation studies
- Extended strategic alliance with the University of Oxford to
support and accelerate the development of future generation
utrophin modulators
CDI Programme
Ridinilazole (formerly SMT19969) Highlights
- Ridinilazole showed substantial clinical benefit over standard
of care CDI antibiotic vancomycin in CoDIFy Phase 2 clinical trial
with a sustained clinical response rate of 66.7% versus 42.4%
driven by a large numerical difference in recurrent disease
- Demonstrated preservation of the gut microbiome in patients
with CDI treated with ridinilazole in Phase 2 while vancomycin
inflicted substantial and long-lasting damage
- Ridinilazole being prepared to enter Phase 3 clinical
trials
- US Food and Drug Administration grant of Fast Track designation
for ridinilazole
- Grant of key patents in the US and Europe protecting
ridinilazole for the treatment of CDI
Operational
- Dr Ralf Rosskamp appointed Chief Medical Officer in September
2015
- Mr David Wurzer joined as a Non-Executive Director in
February 2015
Financial Highlights
- Cash and cash equivalents at 31 January 2016 of £16.3 million
compared to £11.3 million at 31 January 2015
- Loss for the 12 months ended 31 January 2016 of £17.1 million
compared to a loss of £11.3 million for the 12 months ended 31
January 2015
- Completion in March 2015 of initial public offering of American
Depositary Shares on the NASDAQ Global Market that raised gross
proceeds of $39.3 million
Conference Call and Webcast
InformationSummit will host a conference call and webcast
to review the financial results for the fiscal year ended 31
January 2016 today at 1:00pm BST / 8:00am EST. To participate
in the conference call please dial +44 (0)20 3427 1916 (UK and
international participants) or +1 718 354 1152 (US local number)
and use the conference confirmation code 2246763. Investors
may also access a live audio webcast of the call via the investors
section of the Company’s website www.summitplc.com. A replay
of the webcast will be available shortly after the presentation
finishes.
About Summit TherapeuticsSummit
is a biopharmaceutical company focused on the discovery,
development and commercialization of novel medicines for
indications for which there are no existing or only inadequate
therapies. Summit is conducting clinical programs focused on the
genetic disease Duchenne muscular dystrophy and the infectious
disease C. difficile infection. Further information is
available at www.summitplc.com and Summit can be followed on
Twitter (@summitplc).
For more information, please
contact:
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Summit
Therapeutics Glyn Edwards / Richard Pye
(UK office)Erik Ostrowski / Michelle Avery (US office) |
Tel: +44 (0)1235 443
951 +1 617 225 4455 |
Cairn Financial
Advisers LLP (Nominated Adviser)Liam Murray / Tony
Rawlinson |
Tel: +44 (0)20 7148
7900 |
N+1
Singer (Broker)Aubrey Powell / Jen Boorer |
Tel: +44 (0)20 7496
3000 |
MacDougall
Biomedical Communications(US media contact)Chris Erdman /
Karen Sharma |
Tel: +1 781 235 3060
cerdman@macbiocom.com / ksharma@macbiocom.com |
Consilium
Strategic Communications (Financial public relations,
UK)Mary-Jane Elliott / Sue Stuart / Jessica Hodgson / Lindsey
Neville |
Tel: +44 (0)20 3709
5700summit@consilium-comms.com |
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Forward Looking StatementsAny
statements in this press release about our future expectations,
plans and prospects, including statements about clinical
development and commercialisation of our product candidates, the
timing of clinical results, potential third-party collaborations
and expectations regarding the sufficiency of our cash balance to
fund operating expenses and capital expenditures, and other
statements containing the words "anticipate," "believe,"
"continue," "could," "estimate," "expect," "intend," "may," "plan,"
"potential," "predict," "project," "should," "target," "would," and
similar expressions, constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including: the uncertainties inherent in the initiation of
future clinical trials, availability and timing of data from
ongoing and future clinical trials and the results of such trials,
whether preliminary results from a clinical trial will be
predictive of the final results of that trial or whether results of
early clinical trials will be indicative of the results of later
clinical trials, expectations for regulatory approvals,
availability of funding sufficient for our foreseeable and
unforeseeable operating expenses and capital expenditure
requirements and other factors discussed in the "Risk Factors"
section of filings that we make with the Securities and Exchange
Commission. In addition, any forward-looking statements included in
this press release represent our views only as of the date of this
release and should not be relied upon as representing our views as
of any subsequent date. We specifically disclaim any obligation to
update any forward-looking statements included in this press
release.
CHAIRMAN’S STATEMENT
The past year has been one of substantial
momentum for Summit in which a number of important milestones
across the business have been achieved. This commenced with
our successful NASDAQ initial public offering, was followed by
positive clinical data in our Duchenne muscular dystrophy (‘DMD’)
programme that has enabled it to progress into Phase 2 trials, and
culminated in the reporting of proof of concept Phase 2 clinical
data for our novel C. difficile infection (‘CDI’) antibiotic.
These milestones pave the way for another
exciting year to come, which is expected to feature our much
anticipated first look at proof of mechanism data in DMD and
selecting a partner for Phase 3 clinical development and
commercialisation to maximise the potential of our CDI antibiotic.
I believe that the coming period could be a transformational year
for Summit, the patients and families affected by these two serious
diseases, and our shareholders.
Programmes
In DMD, we aim to treat all patients with our
unique orally administered utrophin modulation approach. Utrophin
is a naturally occurring protein that is structurally and
functionally similar to dystrophin, the protein which is lacking in
those with DMD. Utrophin modulation has the potential to slow or
stop the progression of DMD for the entire patient population,
which distinguishes it from many other treatments in development
for this muscle wasting condition.
The roots of the utrophin modulation programme
lie with our co-founder, Prof Kay Davies, at the University of
Oxford, who discovered utrophin and conducted the seminal work to
unlock the potential of utrophin modulation as a universal
treatment of DMD. Summit is focused on maintaining the
Company’s leadership position in utrophin modulation, and
accordingly we are committed to building a strong pipeline of
utrophin modulators.
Our lead utrophin modulator, ezutromid,
successfully completed a Phase 1b clinical trial in boys with DMD
in 2015. Based on the positive results from this trial, we are
poised to start a Phase 2 proof of concept trial called PhaseOut
DMD. This trial aims to assess the effect of ezutromid on
muscle health, function and utrophin levels and we look forward to
reporting data as this trial progresses.
Simultaneously, we continue to develop our
utrophin modulator pipeline, as we seek to maximise the therapeutic
promise of utrophin modulation over the long term. As such, we
recently strengthened our strategic alliance with the University of
Oxford by extending the term of the alliance until at least
November 2019. Supportive of the extension of this collaboration,
we achieved the first research milestone in December 2015 by
selecting two series of utrophin molecules to move into lead
optimisation studies.
We are very excited about the progress made in
2015 in our utrophin modulator programme and are equally excited
about our activities related to its future development. Our
strategy is focussed on independently developing these utrophin
modulators through clinical trials, and if successful,
commercialising them ourselves in Europe and in the United States.
We believe this is achievable as DMD is an orphan disease with a
concentrated network of physicians and patient groups that gives us
the ability to retain the commercial value of this promising
therapeutic approach.
In CDI, our novel antibiotic, ridinilazole,
continues to impress. We were pleased to report excellent top-line
Phase 2 clinical trial results, which have enhanced our belief in
the promise of ridinilazole as a new therapeutic approach capable
of not only treating the initial CDI infection, but also reducing
the high rates of recurrent disease experienced in CDI. In this
trial, ridinilazole demonstrated a large numerical reduction in
rates of recurrent disease over the standard of care, vancomycin.
We believe this was a result of this highly selective antibiotic’s
ability to preserve a patient’s gut microbiome which plays a vital
role in protecting against CDI.
With these data, we believe ridinilazole offers
a clear advantage over conventional broad spectrum antibiotics used
to treat CDI. While continuing to explore all options, our
preferred path forward for ridinilazole is to seek a partner for
Phase 3 development and commercialisation. We will consider a
number of factors as we seek to select a partner who we believe
will maximise ridinilazole’s potential for patients and our
shareholders.
Operational
Operationally, we strengthened our business
across several fronts. We achieved a major milestone in March 2015,
when we successfully completed our NASDAQ initial public offering,
which strengthened our cash position and broadened our access to a
wider network of specialist healthcare investors. This
listing complements our existing listing on AIM, a market of the
London Stock Exchange.
We are also building on and strengthening our
team as clinical programmes continue to progress. This
included the appointment of rare disease drug development expert
and paediatrician, Dr Ralf Rosskamp, as our Chief Medical Officer
in September. His expertise brings great value to our team as we
embark on mid-stage clinical trials with our utrophin modulator
programme. In addition, we have added valued members to our teams
to support our clinical and preclinical activities. I believe these
additions will help Summit to succeed in reaching its planned
milestones.
Board Update
We were pleased to welcome Mr David Wurzer, who
is a seasoned biotechnology and pharmaceutical executive, to our
Board as a Non-Executive Director in February 2015. David’s
financial background is helping to ensure the board has the right
composition to fulfil its regulatory obligations as a dual-listed
company.
Summary & Outlook
In summary, Summit’s strong progress in 2015 has
brought us one step closer to being able to make a meaningful
impact on the lives of patients and families affected by DMD and
CDI. We have entered another potentially pivotal year, where we
hope to see the first signs of proof of mechanism for ezutromid and
utrophin modulation.
I would like to thank all of our shareholders
for their continued support. I also want to extend my sincerest
gratitude to our patients and their families, and the nurses and
doctors who have been involved in our clinical trials. We would not
be where we are without their commitment. Finally, I would like to
thank the Summit team for the hard work and dedication over the
past year that has brought us to this exciting stage in Summit’s
development.
We look forward to updating you on our quest to
advance the current state of care in DMD and CDI.
Frank Armstrong, FRCPE,
FFPMNon-Executive Chairman10 May 2016
OPERATIONAL REVIEW
The period under review has shown significant
progress across all areas of the business. Summit’s utrophin
modulation programme for the treatment of Duchenne muscular
dystrophy (‘DMD’) and novel antibiotic for the treatment of C.
difficile infection (‘CDI’) have each successfully completed
patient clinical trials. The Company also achieved a significant
milestone following the completion of a United States (‘US’)
initial public offering (‘IPO’) of shares on NASDAQ.
Summit Overview
Summit is seeking to treat all patients affected
with the fatal disorder DMD using its utrophin modulation
technology. Summit is also advancing a highly selective antibiotic
to treat CDI.
Summit’s DMD utrophin modulation programme is a
treatment approach independent of the underlying mutations in the
dystrophin gene that cause the disease. Therefore, this approach
has the potential to benefit the entire patient population. Summit
has established a leadership position in the field of utrophin
modulation and is developing a pipeline of first-, second- and
future-generation product candidates. Summit expects to commence
enrolment of patients into a Phase 2 proof of concept trial
evaluating its lead utrophin modulator, ezutromid during the second
quarter of 2016 following the successful completion of a Phase 1b
modified diet clinical trial in patients with DMD.
Summit’s CDI therapy is ridinilazole, a novel
class antibiotic that has the potential to treat the initial
infection and reduce recurrent disease, the key clinical issue in
CDI. In the recent Phase 2 proof of concept clinical trial,
ridinilazole achieved statistical superiority in sustained clinical
response over the antibiotic vancomycin, the current standard of
care in CDI. Ridinilazole is now being prepared for Phase 3
clinical trials.
Duchenne Muscular Dystrophy: Utrophin
Modulation Programme
Background
DMD is the most common and most severe form of
muscular dystrophy. The disease predominately affects males and
results in the progressive wasting of muscles throughout the body.
DMD typically results in death by the time patients reach their
late twenties. Patients with DMD are unable to produce dystrophin,
a protein essential for maintaining healthy muscle function.
Utrophin is a naturally occurring protein that is functionally and
structurally similar to dystrophin, and plays an active role in the
development of new muscle fibres, both in foetal development and in
the repair of damaged muscle fibres. Utrophin production is
switched off in mature muscle fibres, and in the case of a healthy
individual, replaced by the production of dystrophin. Utrophin
modulation has the potential to maintain the production of utrophin
in all skeletal muscles, including the diaphragm and the heart, to
compensate for the absence of functional dystrophin in patients
with DMD and so restore and maintain healthy muscle function. A key
benefit of utrophin modulation is that it is independent of the
underlying genetic fault in the dystrophin gene and so has the
potential to treat the entire patient population.
Summit’s most advanced utrophin modulator is
ezutromid. It is an orally administered small molecule that is
being evaluated in patient clinical trials. Ezutromid has received
orphan drug designation in the United States and Europe.
Ezutromid Clinical Trial
Activities
Ezutromid: Phase 1b Modified Diet Clinical Trial
In September 2015, Summit reported positive data from its Phase 1b
modified diet clinical trial of ezutromid in patients with DMD. The
clinical trial was designed to monitor the impact on absorption of
ezutromid in patients who followed a recommended diet with balanced
proportions of fat, proteins and carbohydrates, and combined that
with consuming a small glass of full fat milk at the time of
dosing.
The detailed analysis presented at the 20th
World Muscle Society Congress showed that the modified diet had a
positive impact on blood plasma levels of ezutromid. All 12
patients in the trial achieved plasma levels that Summit believes
may be able to sustain utrophin protein expression based on in
vitro data generated in myoblast cells from DMD patients and human
myotubes.
Ezutromid: Phase 2 Proof of Concept
TrialEzutromid is progressing into an open label Phase 2 proof of
concept clinical trial. The 48-week open-label trial, called
PhaseOut DMD, is expected to enrol up to 40 boys ranging in age
from their fifth to their tenth birthdays. PhaseOut DMD aims to
provide proof of concept for ezutromid and utrophin modulation
through measurements of muscle fat infiltration, as well as through
measurements of utrophin protein and muscle fibre regeneration in
muscle biopsies. A primary endpoint of the trial is the change from
baseline in magnetic resonance imaging parameters related to fat
infiltration and inflammation of the leg muscles. Functional
endpoints, including the six-minute walk test, North Star
Ambulatory Assessment and patient reported outcomes, are also being
explored.
Summit expects to commence enrolment and dosing
of patients in PhaseOut DMD at trial sites in the United Kingdom
during the second quarter of 2016 and at trial sites in the United
States during the third quarter of 2016. The Company anticipates
reporting data periodically during this trial with 24-week muscle
biopsy data from the first group of patients enrolled expected to
be reported in January 2017.
Ezutromid: Phase 1 New Formulation TrialIn
addition to the current clinical development of ezutromid, Summit
is conducting a Phase 1 clinical trial in healthy volunteers and
patients with DMD to evaluate two potential optimised formulations
of ezutromid. Interim data from this trial were reported in
March 2016.
The two new formulations were tested in healthy
volunteers with one of these achieving an over ten-fold increase in
blood plasma levels compared to the current formulation of
ezutromid. This formulation is now being evaluated in
patients with DMD. Data from the initial dosing period showed
all patients achieved drug levels within the range believed to be
necessary for potential therapeutic benefit. The initial dose
tested was one tenth of that required with the current formulation
to achieve similar drug concentration levels as those observed in
the Phase 1b modified diet clinical trial. The Phase 1 new
formulation trial is now testing a higher dose of the new
formulation and firm decisions on the further development of this
new formulation will await full data from the trial which are
expected in the third quarter of 2016.
Second and Future Generation Utrophin
Modulators
As part of the Company’s strategy to maintain
its leadership position in the field of utrophin modulation, Summit
is advancing a pipeline of second- and future-generation utrophin
modulators.
The second generation utrophin modulators are
structurally related to ezutromid but are designed to have more
favourable pharmaceutical properties. In July 2015, positive
preclinical efficacy data were published in the peer reviewed
journal Human Molecular Genetics on one of Summit’s second
generation utrophin modulators.
Summit also reported progress in the development
of future generation utrophin modulators as part of its strategic
alliance with research teams at the University of Oxford. In
December, Summit announced the nomination of two series of utrophin
modulators, including one with a mechanism that is potentially
distinct from ezutromid, for progression into lead optimisation
studies. This represented the achievement of the first research
milestone as part of the alliance. Summit also announced it has
extended its exclusive strategic alliance with the University of
Oxford until November 2019, with an option to extend it by a
further 12 months. As part of the extension, Summit has committed
to increased funding of the sponsored research programme to £0.83
million a year starting in November 2015.
Patent Grant
Summit was granted a key composition of matter
patent for ezutromid by the European Patent Office in July 2015.
The patent protects ezutromid and its use in the treatment of DMD
in Europe, a major commercial market. The patent (European patent
number 1986633) is entitled “Treatment of Duchenne Muscular
Dystrophy” and will provide a period of exclusivity for ezutromid
through until 2027, with the possibility of a longer effective term
subject to obtaining a Supplementary Protection Certificate on
marketing approval.
C. difficile Infection
Programme
CDI is a major healthcare threat with over one
million annual cases estimated in the United States and Europe.
Mainstay treatments are dominated by broad spectrum antibiotics,
the use of which is associated with high rates of recurrent
disease. With each episode typically being more severe and
associated with increased risk of mortality, recurrent disease is
the key clinical issue in CDI.
Ridinilazole is a novel class antibiotic that
has the potential both to treat the initial infection as well as to
reduce the high rates of recurrent disease experienced in CDI.
Ridinilazole has received Qualified Infectious Disease Product, or
QIDP, designation and has been granted Fast Track status by the US
Food and Drug Administration (‘FDA’).
Ridinilazole Clinical Trial
Activities
Phase 2 Clinical ProgrammeIn November 2015,
Summit announced that ridinilazole showed statistical superiority
in sustained clinical response (‘SCR’) over vancomycin in a Phase 2
proof of concept clinical trial named CoDIFy.
CoDIFy was a double-blind, randomised
active-control trial evaluating the efficacy of ridinilazole
against the current standard of care, the antibiotic vancomycin.
CoDIFy enrolled 100 patients with half the patients receiving ten
days of dosing with ridinilazole (200mg, twice a day), and half the
patients receiving ten days of dosing with vancomycin (125mg, four
times a day). The trial was conducted in the United States and
Canada.
CoDIFy met its primary endpoint with
ridinilazole achieving a SCR rate of 66.7% compared to 42.4% for
vancomycin (non-inferiority margin of 15%, p=0.0004). This also
represented statistical superiority of ridinilazole over vancomycin
using the pre-specified 90% confidence interval. SCR was defined as
clinical cure based on the resolution of diarrhoea at the end of
treatment and no recurrence of CDI within 30 days after the end of
treatment. The difference in SCR was driven by a reduction in
disease recurrence with ridinilazole having a recurrence rate of
14.3% compared to 34.8% with vancomycin. Cure rates at the end of
treatment were 77.8% for ridinilazole compared to 69.7% for
vancomycin.
In addition, preliminary analysis of microbiome
data from CoDIFy shows ridinilazole to be highly preserving of the
gut microbiome. Patients treated with ridinilazole in CoDIFy
exhibited no further damage to their microbiome during therapy with
a proportion of patients showing initial evidence of recovery of
key bacterial groups that play a role in protecting from CDI. In
contrast, patients treated with vancomycin suffered substantial
damage to their gut microbiome during treatment and this persisted
in many patients during the 30-day post treatment period.
In CoDIFy, ridinilazole was generally well
tolerated and the overall adverse event profiles of ridinilazole
and vancomycin were comparable. This primary analysis was conducted
on the modified intent-to-treat, or mITT, population that comprised
patients with CDI confirmed by the presence of free toxin and these
results were consistent across all treatment groups.
In light of these positive Phase 2 data, the
Company is exploring the options for the future development of
ridinilazole, although the preference is to find a partner to
advance ridinilazole to Phase 3 through commercialisation.
An exploratory Phase 2 clinical trial evaluating
ridinilazole against the antibiotic fidaxomicin is currently
ongoing in the UK. The results from this open label trial are
expected to help inform the design of the planned Phase 3 trials
and commercial positioning of ridinilazole. Top-line results from
this trial are expected in the second half of 2016.
Preclinical Activities
Additional preclinical data supporting
ridinilazole as a novel antibiotic for the treatment of CDI with
the potential to reduce the high rates of recurrent disease were
reported at ICAAC in 2015. In these results, ridinilazole was shown
to have high potency against 107 clinical isolates of C. difficile
selected to maximise the diversity of their resistance to common
classes of antibiotics, and ridinilazole continued to display a low
resistance development profile.
In February 2016, data published in the Journal
of Antimicrobial Chemotherapy reported that ridinilazole
outperformed the current standards of care, vancomycin and
metronidazole, in preclinical studies by having a robust killing
effect on C. difficile that significantly reduced the level of
toxins produced by the bacteria that play a major role in driving
the symptoms and severity of the disease.
Fast Track Designation
Ridinilazole was granted Fast Track designation
by the FDA in July 2015. Fast Track designation is awarded to
expedite the development and regulatory review of drugs intended to
treat serious or life-threatening conditions and that demonstrate
the potential to address unmet medical needs.
Patent Grant
In April 2016, a composition of matter patent
covering ridinilazole was granted by the United States Patent and
Trademark Office while in January 2016 a patent covering its use
for the treatment of infections caused by the bacterium Clostridium
difficile was granted by the European Patent Office.
The patents (United States Patent 9,314,456 and European Patent
EP2373631) are entitled ‘Antibacterial Compounds’ and provide a
period of exclusivity for ridinilazole in the United States and
Europe until at least 1 December 2029, with the possibility of
patent term extension in both territories.
The development of ridinilazole has been
financially supported by Seeding Drug Discovery and Translational
Awards from the Wellcome Trust.
Operational Update
In February 2015, the Company changed its
registered name from Summit Corporation plc to Summit Therapeutics
plc with shareholder approval.
In September 2015, Summit appointed Dr Ralf
Rosskamp as Chief Medical Officer based in the Cambridge,
Massachusetts office. Dr Rosskamp was most recently Vice President,
Global Clinical Development, at NPS Pharmaceuticals Inc., where he
oversaw the development of several rare disease drug candidates
from early clinical stage through to regulatory approval. His
expertise in rare and paediatric diseases brings great value to our
team as we embark on mid-stage clinical trials with our utrophin
modulator programme. In addition, we have added valued members to
our teams in the UK and US to support our clinical and preclinical
activities.
Board Changes
In February 2015, Mr David Wurzer was appointed
to the Board as a Non-Executive Director and brings extensive
experience in financial and business matters related to the
pharmaceutical and biotechnology industries having held a number of
senior executive and board level positions. Mr Wurzer is based in
the US.
Financial Review
Other Operating Income
Other operating income decreased by 32.5%, to
£1.4 million during the year ended 31 January 2016 from £2.1
million for the year ended January 31, 2015. Income recognised as
part of the Wellcome Trust Translational Award decreased by £0.4
million to £0.8 million for the year ended 31 January 2016 from
£1.2 million for the year ended 31 January 2015. This change
was a result of a lower contribution rate ascribed to Phase 2
activities as compared to Phase 1 activities under the terms of the
funding agreement. Income recognised as part of the funding from
Innovate UK for the DMD programme decreased by £0.3 million to £0.6
million for the year ended 31 January 2016 from £0.9 million for
the year ended 31 January 2015. The decrease in income is in line
with the achievement of milestones to date under the funding
agreement.
There were no new sources of other operating
income during the year.
Research and Development Expenditure
Research and development expenses increased by
£6.4 million, or 61.8%, to £16.8 million for the year ended 31
January 2016 from £10.4 million for the year ended 31 January 2015.
This was primarily due to investment in the DMD programme, which
increased by £2.8 million to £7.5 million from £4.7 million for the
year ended 31 January 2015, and investment in the CDI programme
which increased by £2.3 million to £5.5 million from £3.2 million
for the year ended 31 January 2015. Other research and development
expenses increased by £1.3 million during the period which is
primarily attributable to an increase in headcount within the DMD
and CDI project teams.
General and Administration Expenditure
General and administration expenses increased by
£0.3 million, or 7.4%, to £4.7 million for the year ended 31
January 2016 from £4.4 million for the year ended 31 January 2015.
This increase included an £0.7 million increase in legal and
professional expenses and other costs associated with being a
publicly traded company in the United States as well as in the
United Kingdom, an increase of £0.4 million in staff related costs,
an increase of £0.2 million in overhead and facility related costs
and an increase of £0.1 million in share based payment expense
offset by £0.7 million in cash infusion milestone payments made to
two US DMD patient groups as part of funding agreements recognised
in July 2014 and £0.4 million recognized as a favourable exchange
rate variance.
Taxation
Our income tax credit increased by £1.8 million,
or 135.8%, to £3.1 million for the year ended 31 January 2016 from
£1.3 million for the year ended 31 January 2015. This was as a
result of increased expenditure on research and development and a
related increase in our research and development tax credit.
Losses
Losses before interest, tax, depreciation and
amortisation were £20.2 million (2014/15: £12.7 million) for the
year. Net loss for the year was £17.1 million (2014/15: £11.4
million) and 0.29 pence per share (2014/15: 0.29 pence per
share).
Cash Flows
The Group had a net cash inflow of £4.9 million for the year
ended 31 January 2016 as compared to a net cash inflow of £9.2
million for the previous year.
Net cash used by operating activities increased
by £5.9 million to £17.2 million for the year ended 31 January 2016
compared to £11.3 million for the year ended 31 January 2015. This
was driven by an increase in research and development expenditure.
Research and development tax credits received during the year
increased by £0.7 million to £1.4 million.
Net cash inflow from financing activities, which
relates to proceeds received from sales of equity securities, was
£22.1 million for the year ended 31 January 2016 compared to £20.5
million for the year ended 31 January 2015.
Financial Position
As at 31 January 2016, total cash and cash equivalents held were
£16.3 million (2015: £11.3 million)
Headcount
Average headcount of the Group for the year was
37 (2015: 23). The increase in headcount is attributable to the
increased activities within the DMD and CDI programmes and the
continued growth of the US operations.
Share Capital
On 5 March 2015 the Company announced a US
initial public offering on the NASDAQ Global Market issuing
3,450,000 American Depositary Shares (‘ADSs’) at a price of $9.90
per ADS. On 18 March 2015, the underwriters exercised in full
their over-allotment option to purchase an additional 517,500 ADSs
on the same terms. Gross proceeds of $39.3 million (£26.1 million)
were raised. Each ADS represents five ordinary shares, thus
19,837,500 Ordinary Shares were issued, which increased the issued
share capital to 60,955,197 Ordinary Shares of 1p value.
During the year 335,543 share options were
exercised raising net proceeds of £0.22 million. Following the
exercise of these share options, the number of Ordinary Shares in
issue was 61,290,740.
Glyn Edwards,
Erik
Ostrowski, Chief Executive Officer
Chief Financial Officer
10 May 2016
FINANCIAL STATEMENTS
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
(audited) For the year ended 31 January 2016
|
|
Year ended 31 January 2016 |
Year ended 31 January 2016 |
Year ended 31 January 2015 |
|
Note |
$000s |
£000s |
£000s |
|
|
|
|
|
Other operating
income |
2 |
|
2,058 |
|
|
1,451 |
|
|
2,148 |
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
Research and
development |
2 |
|
(23,908 |
) |
|
(16,856 |
) |
|
(10,417 |
) |
General and administration |
2 |
|
(6,767 |
) |
|
(4,771 |
) |
|
(4,442 |
) |
Total operating
expenses |
|
|
(30,675 |
) |
|
(21,627 |
) |
|
(14,859 |
) |
|
|
|
|
|
Operating
loss |
|
|
(28,617 |
) |
|
(20,176 |
) |
|
(12,711 |
) |
|
|
|
|
|
Finance
income |
|
|
42 |
|
|
30 |
|
|
51 |
|
|
|
|
|
|
Loss before
income tax |
|
|
(28,575 |
) |
|
(20,146 |
) |
|
(12,660 |
) |
|
|
|
|
|
Income tax |
|
|
4,337 |
|
|
3,058 |
|
|
1,297 |
|
|
|
|
|
|
Loss for the year |
|
|
(24,238 |
) |
|
(17,088 |
) |
|
(11,363 |
) |
|
|
|
|
|
Other
comprehensive (losses) / income |
|
|
|
|
Exchange differences on translating foreign operations |
|
|
(58 |
) |
|
(41 |
) |
|
62 |
|
|
|
|
|
|
Total comprehensive loss for the year |
|
|
(24,296 |
) |
|
(17,129 |
) |
|
(11,301 |
) |
Basic and diluted loss per Ordinary Share from continuing
operations |
3 |
(41)cents |
(29)pence |
(29)pence |
|
|
|
|
|
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
(unaudited) For the three months ended 31 January 2016
|
|
Three months ended 31 January 2016 |
Three months ended 31 January 2016 |
Three months ended 31 January 2015 |
|
|
$000s |
£000s |
£000s |
|
|
|
|
|
Other operating
income |
|
|
344 |
|
|
243 |
|
|
544 |
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
Research and
development |
|
|
(7,087 |
) |
|
(4,997 |
) |
|
(2,775 |
) |
General and administration |
|
|
(1,975 |
) |
|
(1,393 |
) |
|
(1,308 |
) |
Total operating
expenses |
|
|
(9,062 |
) |
|
(6,390 |
) |
|
(4,083 |
) |
|
|
|
|
|
Operating
loss |
|
|
(8,718 |
) |
|
(6,147 |
) |
|
(3,539 |
) |
|
|
|
|
|
Finance
income |
|
|
8 |
|
|
6 |
|
|
10 |
|
|
|
|
|
|
Loss before
income tax |
|
|
(8,710 |
) |
|
(6,141 |
) |
|
(3,529 |
) |
|
|
|
|
|
Income tax |
|
|
1,578 |
|
|
1,113 |
|
|
519 |
|
|
|
|
|
|
Loss for the period |
|
|
(7,132 |
) |
|
(5,028 |
) |
|
(3,010 |
) |
|
|
|
|
|
Other
comprehensive (losses) / income |
|
|
|
|
Exchange differences on translating foreign operations |
|
|
(55 |
) |
|
(39 |
) |
|
54 |
|
|
|
|
|
|
Total comprehensive loss for the period |
|
|
(7,187 |
) |
|
(5,067 |
) |
|
(2,956 |
) |
Basic and diluted loss per Ordinary Share from continuing
operations |
3 |
(11)cents |
(8)pence |
(8)pence |
|
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
(audited)As at 31 January 2016
|
|
|
|
|
|
|
31 January 2016 |
31 January 2016 |
31 January 2015 |
|
|
$000s |
£000s |
£000s |
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
Goodwill |
|
|
941 |
|
|
664 |
|
|
664 |
|
Intangible assets |
|
|
4,926 |
|
|
3,473 |
|
|
3,483 |
|
Property,
plant and equipment |
|
|
117 |
|
|
83 |
|
|
55 |
|
|
|
|
5,984 |
|
|
4,220 |
|
|
4,202 |
|
Current
assets |
|
|
|
|
Prepayments and other
receivables |
|
|
2,181 |
|
|
1,538 |
|
|
2,630 |
|
Current tax |
|
|
4,275 |
|
|
3,014 |
|
|
1,299 |
|
Cash and
cash equivalents |
|
|
23,125 |
|
|
16,304 |
|
|
11,265 |
|
|
|
|
29,581 |
|
|
20,856 |
|
|
15,194 |
|
|
|
|
|
|
Total assets |
|
|
35,565 |
|
|
25,076 |
|
|
19,396 |
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
Non-current
liabilities |
|
|
|
|
Provisions for other
liabilities and charges |
|
|
(103 |
) |
|
(73 |
) |
|
(45 |
) |
Deferred tax
liability |
|
|
(941 |
) |
|
(664 |
) |
|
(664 |
) |
|
|
|
(1,044 |
) |
|
(737 |
) |
|
(709 |
) |
Current liabilities |
|
|
|
|
Trade and other
payables |
|
|
(4,547 |
) |
|
(3,206 |
) |
|
(3,721 |
) |
|
|
|
(4,547 |
) |
|
(3,206 |
) |
|
(3,721 |
) |
|
|
|
|
|
Total liabilities |
|
|
(5,591 |
) |
|
(3,943 |
) |
|
(4,430 |
) |
|
|
|
|
|
Net assets |
|
|
29,974 |
|
|
21,133 |
|
|
14,966 |
|
|
|
|
|
|
EQUITY |
|
|
|
|
Share capital |
|
|
869 |
|
|
613 |
|
|
411 |
|
Share premium
account |
|
|
65,296 |
|
|
46,035 |
|
|
24,101 |
|
Share-based payment
reserve |
|
|
5,328 |
|
|
3,757 |
|
|
2,597 |
|
Merger reserve |
|
|
(2,755 |
) |
|
(1,943 |
) |
|
(1,943 |
) |
Special reserve |
|
|
28,358 |
|
|
19,993 |
|
|
19,993 |
|
Currency translation
reserve |
|
|
29 |
|
|
21 |
|
|
62 |
|
Accumulated losses reserve |
|
|
(67,151 |
) |
|
(47,343 |
) |
|
(30,255 |
) |
Total equity |
|
|
29,974 |
|
|
21,133 |
|
|
14,966 |
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENT OF CASH FLOWS (audited)
For the year ended 31 January 2016
|
|
|
|
|
|
|
Year ended 31 January 2016 |
Year ended 31 January 2016 |
Year ended 31 January 2015 |
|
|
$000s |
£000s |
£000s |
Cash flows from
operating activities |
|
|
|
|
Loss before income
tax |
|
|
(28,575 |
) |
|
(20,146 |
) |
|
(12,660 |
) |
|
|
|
(28,575 |
) |
|
(20,146 |
) |
|
(12,660 |
) |
|
|
|
|
|
Adjusted for: |
|
|
|
|
Finance income |
|
|
(42 |
) |
|
(30 |
) |
|
(51 |
) |
Foreign exchange
(gain)/loss |
|
|
(239 |
) |
|
(169 |
) |
|
78 |
|
Depreciation |
|
|
53 |
|
|
38 |
|
|
23 |
|
Amortisation of
intangible fixed assets |
|
|
14 |
|
|
10 |
|
|
10 |
|
Movement in
provisions |
|
|
39 |
|
|
28 |
|
|
28 |
|
Research and
development expenditure credit |
|
|
(62 |
) |
|
(44 |
) |
|
(39 |
) |
Share-based payment |
|
|
1,645 |
|
|
1,160 |
|
|
961 |
|
Adjusted loss
from operations before changes in working capital |
|
|
(27,167 |
) |
|
(19,153 |
) |
|
(11,650 |
) |
|
|
|
|
|
Decrease/(Increase) in
prepayments and other receivables |
|
|
1,568 |
|
|
1,106 |
|
|
(2,200 |
) |
(Decrease)/Increase in trade and other payables |
|
|
(760 |
) |
|
(536 |
) |
|
1,867 |
|
Cash used by
operations |
|
|
(26,359 |
) |
|
(18,583 |
) |
|
(11,983 |
) |
|
|
|
|
|
Taxation
received |
|
|
1,987 |
|
|
1,401 |
|
|
658 |
|
Net cash used in operating activities |
|
|
(24,372 |
) |
|
(17,182 |
) |
|
(11,325 |
) |
|
|
|
|
|
|
|
|
|
|
Investing
activities |
|
|
|
|
Purchase of property, plant and equipment |
|
|
(93 |
) |
|
(66 |
) |
|
(35 |
) |
Interest received |
|
|
42 |
|
|
30 |
|
|
51 |
|
Net cash (used)/generated by investing
activities |
|
|
(51 |
) |
|
(36 |
) |
|
16 |
|
|
|
|
|
|
Financing
activities |
|
|
|
|
Proceeds from issue of
share capital |
|
|
37,021 |
|
|
26,101 |
|
|
22,000 |
|
Transaction costs on
share capital issued |
|
|
(5,938 |
) |
|
(4,187 |
) |
|
(1,482 |
) |
Exercise of share
options |
|
|
314 |
|
|
222 |
|
|
26 |
|
Net cash generated from financing activities |
|
|
31,397 |
|
|
22,136 |
|
|
20,544 |
|
|
|
|
|
|
Increase in
cash and cash equivalents |
|
|
6,974 |
|
|
4,918 |
|
|
9,235 |
|
|
|
|
|
|
Effect of
exchange rates in cash and cash equivalents |
|
|
173 |
|
|
121 |
|
|
- |
|
|
|
|
|
|
Cash and cash
equivalents at beginning of year |
|
|
15,978 |
|
|
11,265 |
|
|
2,030 |
|
|
|
|
|
|
Cash and cash equivalents at end of year |
|
|
23,125 |
|
|
16,304 |
|
|
11,265 |
|
|
|
|
|
|
|
|
|
|
|
|
NOTES TO THE FINANCIAL STATEMENTSFor the year
ended 31 January 2016
1. Basis of accounting
This financial information for the years ended
31 January 2016 and 31 January 2015 does not constitute the
statutory financial statements for the respective years and is an
extract from the financial statements. It is based on, and is
consistent with, the Group’s statutory accounts for the year ended
31 January 2016 and those financial statements will be delivered to
the Registrar of Companies following the Company’s 2016 Annual
General Meeting. Financial statements for the year ended 31
January 2015 have been delivered to the Registrar of Companies. The
financial statements for the years ended 31 January 2016 and 2015
contain an unqualified report from the Company’s auditors. The
financial statements for the year to 31 January 2016 also contain a
statement from the auditors drawing shareholders’ attention to the
Group’s need to raise additional capital as noted below.
These financial statements have been prepared
assuming the Group will continue on a going-concern basis.
Based on management forecasts, the Group’s existing cash and
cash equivalents will be sufficient to enable the Group to fund the
operating expenses and capital expenditure requirements for its
major programmes up until 31 January 2017. The Group
therefore needs to raise additional capital to continue to fund its
future operations, which may come from a public or private fund
raising, though there can be no assurance that the Group will be
able to generate funds in this manner, on terms acceptable to the
Group, on a timely basis or at all, which would impact the Group’s
ability to continue as a going concern.
The financial information in this report does
not constitute statutory financial statement within the meaning of
Sections 434-436 of the Companies Act 2006.
The consolidated financial statements have been
prepared in accordance with International Financial Reporting
Standards (‘IFRS’) as issued by the International Accounting
Standards Board (‘IASB’) and as adopted by the European Union, IFRS
Interpretations Committee (‘IFRIC’) Interpretations and the
Companies Act 2006 applicable to companies reporting under IFRS.
The Consolidated Financial Statements have been prepared on a going
concern basis and under the historical cost convention. Whilst the
financial information included in this preliminary announcement has
been prepared in accordance with IFRSs adopted for use in the
European Union and as issued by the International Accounting
Standards Board, this announcement does not itself contain
sufficient information to comply with IFRSs.
This announcement is available from the Company
Secretary and is on the Company’s website.
The financial information for the three-month
periods ended 31 January 2016 and 2015 is unaudited.
Solely for the convenience of the reader, unless
otherwise indicated, all pound sterling amounts stated in the
Consolidated Balance Sheet as at 31 January 2016 and in the
Consolidated Income Statement and Consolidated Cash Flow Statement
for the year and 3 months ended 31 January 2016 have been
translated into US dollars at the rate on 29 January 2016 of
$1.4184 to £1.00. These translations should not be considered
representations that any such amounts have been, could have been or
could be converted into US dollars at that or any other exchange
rate as at that or any other date.
The Board of Directors of the Company approved
this statement on 10 May 2016.
2. Loss before income tax
|
|
|
|
|
Year ended 31 January 2016
£000s |
|
Year ended 31 January 2015 £000s |
Other operating income |
|
|
|
Income
recognised in respect of the Wellcome Trust |
|
762 |
|
|
|
1,169 |
|
Grant
income (a) |
|
645 |
|
|
|
860 |
|
Other
income (a) |
|
- |
|
|
|
79 |
|
Research and development expenditure credit |
|
44 |
|
|
|
40 |
|
|
|
1,451 |
|
|
|
2,148 |
|
Research and development |
|
|
|
Employee
benefit expense |
|
2,848 |
|
|
|
1,690 |
|
Share-based payment expense |
|
356 |
|
|
|
256 |
|
Programme related costs |
|
13,093 |
|
|
|
7,869 |
|
Amortisation of intangible assets |
|
10 |
|
|
|
10 |
|
Other research and development costs |
|
549 |
|
|
|
592 |
|
|
|
16,856 |
|
|
|
10,417 |
|
General and administration |
|
|
|
Employee
benefit expense |
|
1,365 |
|
|
|
1,382 |
|
Share-based payment expense |
|
804 |
|
|
|
705 |
|
Foreign
exchange (gain)/loss |
|
(501 |
) |
|
|
(91 |
) |
Depreciation of property, plant and equipment |
|
38 |
|
|
|
23 |
|
Operating lease rentals |
|
131 |
|
|
|
73 |
|
Other general and administration costs |
|
2,934 |
|
|
|
2,350 |
|
|
|
4,771 |
|
|
|
4,442 |
|
|
|
|
|
|
|
|
|
(a) Included in other income are amounts recognised from the
arrangements with philanthropic, non-government and not for profit
organisations and patient advocacy groups, in support of the DMD
programme. Grant income includes amounts received from Innovate UK.
The Group has complied with all the conditions attached to these
awards.
3. Loss per share
The loss per Ordinary Share has been calculated
using the loss for the year of £17,088,000 and for the three month
period to 31 January 2016, the loss of £5,028,000 (year ended 31
January 2015: loss of £11,363,000, three month period ended 31
January 2015: £3,010,000) and dividing this by the weighted average
number of Ordinary Shares in issue during the year to 31 January
2016: 59,102,292 and during the three month period to 31 January
2016: 61,290,740 (year ended 31 January 2015: 39,599,222, the three
month period ended 31 January 2015: 39,057,313).
Since the Group has reported a net loss from
continuing activities, diluted loss per share is equal to basic
loss per share.
4. Subsequent Events
On 14 April 2016, the number of Ordinary Shares
increased to 61,467,785 following the exercise of warrants over
177,045 Ordinary Shares at an exercise price of 60 pence per share.
The issue of new shares raised net proceeds of £106,227.
- END -
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