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 year ended 31 January
2015.
Dr Frank Armstrong, Non-Executive Chairman of Summit
commented: "It has been a year of substantial progress
that has seen Summit's lead product candidates for the treatment of
DMD and CDI progress into clinical trials in patients, expansion of
our operations into the United States and receipt of strong
financial backing from new and existing investors that culminated
in the successful offering on NASDAQ. It is my belief that Summit
is well placed to achieve a number of key clinical milestones in
the coming year as we seek to establish the potential of our two
programmes as potential life-changing treatments."
HIGHLIGHTS
DUCHENNE MUSCULAR DYSTROPHY PROGRAMME
- Completion of first DMD patient Phase 1b clinical trial of a
utrophin modulator therapy with SMT C1100 shown to be well
tolerated at all doses tested.
- Potential SMT C1100 activity in Phase 1b clinical trial with
statistically significant reduction observed in the levels of three
enzymes associated with muscle damage.
- Initiation of new Phase 1b clinical trial of SMT C1100 to
evaluate impact of modified diet in DMD patients; all patients
enrolled and dosing on-going with top-line data expected to be
reported in Q3 2015.
- Plan to initiate Phase 2 open label clinical trial of SMT C1100
in H2 2015 and randomised placebo controlled Phase 2 clinical trial
of SMT C1100 in early 2016.
C. DIFFICILE INFECTION PROGRAMME
- Phase 2 proof of concept clinical trial on-going in US and
Canada with enrolment and dosing of patients underway; top line
data expected in H2 2015.
- SMT19969 designated as a Qualified Infectious Disease Product
('QIDP') by the US Food and Drug Administration.
- £1.9 million milestone payment received as part of the Wellcome
Trust Translational Award.
OPERATIONAL HIGHLIGHTS
- Strengthening of Board of Directors and Executive Management,
including the appointment of Mr Erik Ostrowski as Chief Financial
Officer.
- US operations established through opening of Cambridge,
Massachusetts office.
- Change of registered name to Summit Therapeutics plc in
February 2015.
FINANCIAL HIGHLIGHTS
- Cash and cash equivalents at 31 January 2015 of £11.3 million
compared to £2.0 million at 31 January 2014.
- £22.0 million (£20.5 million net of costs) financing through
issue of new Ordinary Shares completed in March 2014.
- Loss for the year ended 31 January 2015 of £11.3 million
compared to £6.1 million for the year ended 31 January 2014.
NASDAQ INITIAL PUBLIC OFFERING
- Initial public offering of American Depositary Shares in the
United States and listing on the NASDAQ Global Market completed in
March 2015 (post period end).
- Gross proceeds of $39.3 million (£25.8 million) raised.
Conference Call and Webcast Information
Summit will host a conference call and webcast to review the
financial results for the fiscal year ended 31 January 2015 today
at 1:00pm BST / 8:00am EDT. To participate in the conference call,
please dial +44 (0)20 7136 2055 (UK and international participants)
or +1 718 354 1158 (US local number) and use the conference
confirmation code 5108710. 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 Therapeutics
Summit 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:
Summit Therapeutics Glyn
Edwards / Richard Pye (UK office) Erik Ostrowski
(US office) |
Tel: +44 (0)1235 443 951
+1 617 294 6607 |
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Cairn Financial Advisers LLP
(Nominated Adviser) Liam Murray / Tony Rawlinson |
Tel: +44 (0)20 7148 7900 |
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N+1 Singer (Broker) Aubrey
Powell / Jen Boorer |
Tel: +44 (0)20
7496 3000 |
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MacDougall Biomedical
Communications (US media contact) Michelle Avery |
Tel: +1 781 235 3060
mavery@macbiocom.com |
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Peckwater PR (Financial
public relations, UK) Tarquin Edwards |
Tel: +44 (0)7879 458 364
tarquin.edwards@peckwaterpr.co.uk |
Forward Looking Statements
Any statements in this press release about our future
expectations, plans and prospects, including statements about
clinical development of our product candidates, the timing of
clinical results 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
I am pleased to report that it has been a year of substantial
progress that has seen Summit's lead product candidates progress
into clinical trials in patients, expansion of our operations into
the United States and receipt of strong financial backing from
investors that culminated in the successful NASDAQ initial public
offering.
It is my belief that Summit is in a strong position to achieve a
number of key clinical milestones in the coming year that have the
potential to benefit patients and their families, along with our
shareholders.
Programmes
Our novel utrophin modulation programme for the treatment of
Duchenne muscular dystrophy ('DMD') provides Summit with the
opportunity to treat all patients with this devastating muscle
wasting condition. Utrophin modulation is a scientific approach
that has the potential to slow or even stop progression of DMD and
would be applicable to all DMD patients, regardless of the
underlying genetic faults. It would also potentially be
complementary to other disease modifying approaches in development
that only target small sub-sets of DMD patients.
We are seeking to capitalise on this opportunity by developing a
pipeline of utrophin modulator drugs. Summit has an established
leadership position in this field of research, strengthened through
our strategic alliance with the University of Oxford. This includes
the research team of co-founder and scientific adviser Professor
Kay Davies who pioneered utrophin modulation as a DMD treatment
approach.
Our strategic ambition for the DMD programme is to independently
develop a utrophin modulator drug through clinical trials and, if
successful, commercialise it ourselves in the United States and
Europe. We believe this is achievable as DMD is an orphan disease
with a concentrated network of clinicians and patient advocacy
groups that gives us the ability to retain the commercial value of
this promising therapeutic approach.
Our lead utrophin modulator, SMT C1100, progressed into clinical
trials in patients during 2014. Further clinical data is
anticipated during 2015 as we work towards commencing a Phase 2
proof of concept efficacy trial that will seek to validate the
potential of utrophin modulation as a new treatment paradigm for
all DMD patients. Our earlier-stage pipeline continues to advance
in parallel as we seek to identify second and future generation
utrophin based therapies in order to maintain our leadership
position in this research field.
Our novel antibiotic SMT19969 for the treatment of C. difficile
infection ('CDI') has the potential to address another healthcare
threat that is poorly served by current treatments. In 2014 an
investigational new drug application ('IND') in the US was opened
for SMT19969. SMT19969 has progressed into a Phase 2 proof of
concept trial and with enrolment and dosing on-going, top-line data
is expected to be reported in the second half of 2015. In addition,
a separate open label Phase 2 trial is being undertaken that we
anticipate will inform our future clinical development plans for
this novel antibiotic.
Our strategic objective with SMT19969 is to maximise its
commercial potential either independently or through establishing
collaboration partnerships. The board of directors will continue to
evaluate the relative merits of these options and seek to provide
the greatest value for patients and our shareholders.
Operational
We were pleased to complete our NASDAQ initial public offering
in March 2015. The offering has provided the Company with
additional funds and increased access to a wider network of
specialist healthcare investors. This new capital has enhanced our
immediate ability to advance the development of our two product
candidates and our earlier stage pipeline of utrophin modulators.
The NASDAQ listing also complements our listing on AIM, a market of
the London Stock Exchange.
The Company expanded during the year to support the progression
of our two clinical programmes. We now have operations in the
United States through our office in Cambridge, Massachusetts. This
physical presence in the United States will support greater
interactions with academic, clinical and business leaders in our
two areas of therapeutic development. The operations team in the UK
and US continues to be strengthened to support our efforts of
reaching key inflection points in our two programmes. In February
2015, the Company changed its name to Summit Therapeutics plc. This
new name directly references our sector of business and I believe
will help increase our profile and marketability with investors and
the wider life sciences industry.
Board Update
I was pleased to welcome a number of new faces to the Board of
Directors with Mr Leopoldo Zambeletti, Ms Valerie Andrews and Mr
David Wurzer joining as Non-Executive Directors. They each have a
wealth of experience in the global life sciences industry and will
be of great assistance as we pursue our business strategy. In
addition, Mr Jim Mellon stepped down from the Board, and I would
like to thank him for his efforts during his time as a
Non-Executive Director.
Summary & Outlook
The Company has made good progress and is well positioned to
achieve a number of important clinical milestones over the coming
year. I would like to thank all our shareholders for their
continued support, which has been essential in the advancement of
our two programmes. I would also like to thank all the patients and
their families, and the doctors and nurses, who have been involved
in our various clinical trials. Finally, I would like to thank all
our staff for their continued dedication and commitment that has
enabled the Company to progress over the last year. We are all
excited about our future prospects as we look to meet the needs of
patients and their families affected by two serious diseases.
Frank Armstrong, FRCPE, FFPM
Non-Executive Chairman 6 May 2015
OPERATIONAL OVERVIEW
It has been a period of 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 advanced into patient clinical trials. The Company also
achieved a significant milestone following the completion of a US
initial public offering ('IPO') of shares on NASDAQ. This IPO has
strengthened the financial resources of the Company and will
support its future clinical development plans as Summit seeks to
exploit the promise of its DMD and CDI programmes.
Summit Overview
Summit is seeking to treat all boys afflicted with the fatal
disease Duchenne muscular dystrophy ('DMD') using its pioneering
utrophin modulation technology. Summit is also advancing a highly
selective antibiotic to treat Clostridium difficile infection
('CDI').
Summit's DMD utrophin modulation programme is a treatment
approach that is independent of the underlying mutations in the
dystrophin gene that cause the disease and so has the potential to
address the entire population of DMD patients. Summit has
established a leadership position in the field of utrophin
modulation. Summit is currently evaluating its most advanced
product candidate, SMT C1100, in clinical trials in DMD patients
and, in parallel, Summit is also developing an earlier stage
pipeline of second and future generation utrophin modulators.
Summit's CDI therapy in clinical development is SMT19969, an
orally administered small molecule antibiotic. SMT19969 is designed
to selectively target Clostridium difficile bacteria without
causing collateral damage to the gut flora of patients, and thereby
reduce CDI recurrence rates, the key clinical issue in this
disease.
Nasdaq Listing And Equity Offering
Summit successfully completed a US initial public offering on
the NASDAQ Global Market issuing 3,967,500 American Depositary
Shares ('ADSs') at an offering price of $9.90 per ADS in March
2015. Total gross proceeds were $39.3 million (£25.8 million). Each
ADS represents five Ordinary Shares of 1 pence each in the capital
of the Company. The ADSs trade on NASDAQ under the symbol 'SMMT'
and this listing complements the listing of the Company's Ordinary
Shares on AIM, a market of the London Stock Exchange, that trade
under the symbol 'SUMM'.
The NASDAQ listing was an important strategic event for Summit.
The Company believes that it will provide greater access to the
large number of specialist healthcare investors in the US, as well
as increase liquidity in the trading of its shares.
The funds raised in the US IPO have strengthened the financial
position of the Company and will support the on-going clinical
development of its lead product candidates, SMT C1100 and SMT19969.
The additional funds will also support the parallel development of
its pipeline of future generation utrophin modulators as the
Company seeks to maintain its leadership position in this field of
DMD research.
Duchenne Muscular Dystrophy 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. Utrophin 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 replaced by
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 DMD patients 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.
SMT C1100 Clinical Trial Activities
Initial Phase 1b Clinical Trial in DMD Patients
SMT C1100 is an orally administered small molecule. In 2014, the
Company completed a Phase 1b trial of SMT C1100 which was the first
trial of a utrophin modulator to be conducted in DMD patients. This
Phase 1b trial achieved its primary endpoint with SMT C1100 shown
to be well tolerated at all doses tested. In addition, there was an
excellent rate of patient compliance.
The Phase 1b was a non-placebo controlled trial that reported
results that the Company believe are encouraging about the
disease-modifying potential of SMT C1100. The trial enrolled a
total of 12 boys with DMD who were between the ages of 5 and 11
years old. After 10 days of dosing, a reduction was observed in the
enzymes creatine kinase ('CK'), asparate aminotransferase ('AST')
and alanine aminotransferase ('ALT'). The levels of these three
enzymes are typically low in healthy people but elevated in DMD
patients due to the disease weakening their muscle cells and leads
to the accumulation of the enzymes in the blood. When dosed with
SMT C1100, there was a reduction in CK (10/11 patients), AST (11/12
patients) and ALT (12/12 patients). After dosing, the enzyme levels
increased towards pre-dose levels. Summit believes that the lower
levels of CK, AST and ALT compared to baseline potentially indicate
a reduction in muscle damage and may be evidence of SMT C1100
activity.
These encouraging enzyme data on SMT C1100 were achieved with
levels of drug uptake in the majority of patients that we believe
can be improved on. In a Phase 1 healthy volunteer trial completed
in 2012, higher blood plasma levels of SMT C1100 were achieved when
the drug was dosed with food. In the Phase 1b trial, despite being
administered with food, there was variability between patients with
the majority having plasma levels that were similar to those of a
fasted healthy volunteer. Initial evidence suggests that this may
be due to the difference in diet of DMD patients and other disease
related factors.
Phase 1b Modified Diet Clinical Trial
In December 2014, Summit received approval from the UK
regulatory and ethics committee to initiate a new Phase 1b clinical
trial in DMD patients. This new trial is a randomised, placebo
controlled study that aims to increase the blood plasma levels of
SMT C1100 compared to those observed in the previous open label
Phase 1b trial by providing patients with specific dietary guidance
recommending balanced proportions of fat, protein and
carbohydrates. The trial is also evaluating the potential impact of
SMT C1100 on enzyme biomarkers that are related to muscle health,
and further evaluating the safety and tolerability of the drug.
The trial is now fully enrolled with 12 DMD patients between the
ages of 5 and 13 years divided equally into three cohorts. The
trial comprises three randomised 14-day treatment periods during
which each patient will receive two different doses of SMT C1100
and a placebo control. There is a wash-out period of at least 14
days between each of the three treatment periods.
Summit expects to report top-line data from this trial in the
third quarter of 2015.
Future Clinical Trial Plans
If the Phase 1b modified diet trial is successful, Summit plans
to initiate a Phase 2 open label trial in DMD patients designed to
evaluate the longer-term effects of SMT C1100 on muscle health,
function and safety. The Company's objective is to obtain
regulatory approval for the Phase 2 open label trial in parallel
with the on-going Phase 1b trial to minimise the time between
completion and commencement of the two studies. Summit also plans
to conduct a larger, multinational Phase 2 placebo controlled trial
that is expected to include sites in the United States and
Europe.
Second and Future Generation Utrophin
Modulators
Summit is also developing a pipeline of second and future
generation utrophin modulators as part of the Company's strategy to
maintain its leadership position in the field of utrophin research.
The second generation molecules are structurally related to SMT
C1100, but are designed to have more favourable pharmacokinetic
properties to achieve higher drug uptake. At the 19th World Muscle
Society Congress, new preclinical data was unveiled on the second
generation molecules, which demonstrated that they had a positive
benefit on utrophin protein expression and muscle function and
health.
C. difficile Infection Programme
SMT19969 is a novel antibiotic being evaluated in patient
clinical trials for the treatment of infections caused by the
bacteria Clostridium difficile. SMT19969 is a novel class of
antibiotic and is designed to selectively target C. difficile
bacteria without causing collateral damage to the gut flora and
thereby reduce CDI recurrence rates.
SMT19969 Clinical Trial Activities
In 2014, Summit opened an investigational new drug application
and commenced a Phase 2 proof of concept clinical trial. This
trial, named CoDIFy, is a double-blind, randomised active control
trial evaluating the efficacy of SMT19969 against the current
standard of care, the antibiotic vancomycin. CoDIFy is being
conducted in the US and Canada and will enrol up to 100 patients
with half the patients receiving ten days of dosing with SMT19969,
and the remaining patients receiving ten days of dosing with
vancomycin.
The primary endpoint of the trial is sustained clinical response
that is defined as clinical cure based on the resolution of
diarrhoea at the test of cure visit on day 12 and no recurrence of
CDI within 30 days after the end of treatment. The trial will
examine a number of secondary endpoints including the safety and
tolerability of SMT19969, and the impact of the antibiotic on the
gut flora of patients. Top-line results from this trial are
expected to be reported in the second half of 2015.
In addition to the Phase 2 proof of concept trial, Summit has
commenced dosing in an exploratory, open-label Phase 2 clinical
trial that is evaluating SMT19969 against the recently launched
antibiotic fidaxomicin. This trial, being conducted in the UK, will
generate further data intended to inform the design of future Phase
3 clinical trials of SMT19969. It is expected that top-line data
from this trial will be reported in the first half of 2016.
QIDP Status
In July 2014 SMT19969 was designated by the US Food and Drug
Administration ('FDA') as a qualified infectious disease product
('QIDP'). This status recognises the serious threat posed by
specific life-threatening pathogens, including C. difficile, and
will confer a number of advantages that are intended to accelerate
the development of new antibiotics. These include eligibility of
Priority Review and Fast Track status and, if SMT19969 receives
marketing approval from the FDA, a five year extension of market
exclusivity. The QIDP incentives are provided under the Generating
Antibiotics Incentives Now Act ('GAIN Act') that was signed into
law by the US Government in 2012.
Preclinical Activities
Positive data from a series of preclinical in vivo and in vitro
efficacy studies were presented at the 54th ICAAC Conference in
September 2014. The results show that SMT19969 demonstrated
superiority over vancomycin by providing increased survival rates
and prevention of recurrent disease, displaying superior C.
difficile killing, and reduced toxin production.
Commenting on the data and profile of SMT19969, infectious
disease expert and hospital epidemiologist Dale Gerding MD,
Professor of Medicine at Loyola University Stritch School of
Medicine, said, "C. difficile infection is associated with high
levels of recurrent disease and, to reduce this, it is imperative
that antibiotics which minimise impact on the natural bacterial
flora of the gut are used. The gut flora and its protective role
are typically disrupted in CDI patients. Antibiotics that have a
targeted spectrum of activity, such as SMT19969, could allow
restoration of the protective flora to happen sooner and so reduce
disease recurrence. The results on SMT19969 are encouraging, and it
warrants further evaluation in patient clinical trials."
The development of SMT19969 continues to be supported by a £4.0
million Wellcome Trust Translational Award through to completion of
the Phase 2 proof of concept clinical trial.
Operational Update
In June 2014 Summit established US operations with the opening
of an office in Cambridge, Massachusetts. This expansion is
intended to help support both clinical programmes, as each will
have a significant proportion of their development undertaken in
North America.
The operational and clinical development team has also been
strengthened. Notably, Mr Erik Ostrowski was appointed the
Company's Chief Financial Officer in June 2014. Prior to joining
Summit, Erik held a senior management position with the
biotechnology company Organogenesis. He also had a successful
career in healthcare investment banking, most recently with Leerink
Partners. Erik works out of the Company's US office.
In February 2015, the Company received authority from
shareholders to enable a change of registered name from Summit
Corporation plc to Summit Therapeutics plc. The new identity
directly references the Company's area of business and the Company
believes will help increase the marketability of the Company
amongst specialist healthcare investors and improve its visibility
within the wider life sciences industry.
Board Changes
There have also been a number of changes to the Board of
Directors. Mr Leopoldo Zambeletti was appointed as a Non-Executive
Director in May 2014. He is a highly respected and experienced
investment banker and brings expertise in a range of areas,
including mergers and acquisitions, equity financings, and product
out-licensing. Ms Valerie Andrews joined the Board in September
2014 as a Non-Executive Director. She brings a broad set of
commercial and legal skills from a career in the healthcare and
life sciences industry that included most recently serving as
General Counsel for the NASDAQ listed company Vertex
Pharmaceuticals Inc. 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. Ms Andrews
and Mr Wurzer are both based in the US. Mr Jim Mellon stepped down
as a Non-Executive Director in December 2014 due to the pressure of
his other work responsibilities.
FINANCIAL REVIEW
Other Operating Income
Other operating income increased by 16.5%, to £2.1 million
during the year ended 31 January 2015 from £1.8 million for the
year ended 31 January 2014. The £2.1 million in other operating
income was comprised of £1.2 million in respect of income
recognised from the Wellcome Trust in support of the CDI clinical
programme and £0.9 million recognised in respect of funding
received from Innovate UK (formerly the Technology Strategy Board)
to support the development of our lead utrophin modulator SMT
C1100.
There were no new sources of other operating income during the
year.
Research and Development Expenditure
Research and development expenses increased by £3.8 million, or
57.6%, to £10.4 million for the year ended 31 January 2015 from
£6.6 million for the year ended 31 January 2014. This was primarily
due to investment in the DMD programme, which increased by £1.8
million to £4.7 million from £2.9 million for the year ended 31
January 2014, and investment in the CDI programme which increased
by £1.1 million to £3.2 million from £2.1 million for the year
ended 31 January 2014. Other research and development expenses
increased by £0.9 million during the period which is attributable
to an increase in headcount within the DMD and CDI project
teams.
General and Administration Expenditure
General and administration expenses increased by £2.5 million,
or 128.7%, to £4.4 million for the year ended January 31, 2015 from
£1.9 million for the year ended 31 January 2014. This increase
included £0.7 million in milestone payments made to two US DMD
patient groups as part of funding agreements entered into with
these patient groups, an increase in staff related costs of £1.0
million, an increase of £0.5 million in share-based payment expense
and a £0.3 million increase in legal and professional expenses.
Taxation
Our research and development tax credit increased by £0.7
million, or 113.7%, to £1.3 million for the year ended 31 January
2015 from £0.6 million for the year ended 31 January 2014. This was
as a result of increased expenditure on research and development
and a related increase in our research and development tax
credit.
Losses
Loss before income tax was £12.7 million (2013/14: £6.7
million). Net loss for the year was £11.3 million (2013/14: £6.1
million) and 29 pence per share (2013/14: 30 pence per share)
(adjusted for the share consolidation).
Cash Flows
The Group had a net cash inflow of £9.2 million for the year
ended 31 January 2015 as compared to a net cash outflow of £1.3
million for the previous year.
Net cash used by operating activities increased by £5.4 million
to £11.3 million for the year ended 31 January 2015 compared to
£5.9 million for the year ended 31 January 2014. This was driven by
an increase in research and development investment, as well as an
overall increase in general and administration costs. Research and
development tax credits received during the year increased by £0.3
million to £0.6 million.
Net cash inflow from financing activities increased by £16.0
million to £20.5 million for the year ended 31 January 2015 due to
the receipt of net proceeds of £20.5 million from an equity placing
completed in March 2014.
Financial Position
As at 31 January 2015, total cash and cash equivalents held were
£11.3 million (2014: £2.0 million).
Headcount
Average headcount of the Group for the year was 23 (2014: 17).
The increase in headcount is attributable to the increased
activities within the DMD and CDI programmes and the establishment
of the US office.
Share Capital
On 4 March 2014 the number of Ordinary Shares in issue increased
to 821,228,226 following the placing of 338,461,560 1p Ordinary
Shares. The equity placing raised net proceeds of £20.5
million.
During the period the Company completed a share capital
reorganisation. This reduced the number of Ordinary Shares in issue
through a 20 for 1 consolidation, a capital reduction with the
cancellation of all Deferred Shares, and the reduction of the
Company's share premium account. On 3 July 2014, prior to the share
consolidation, 14 new Ordinary Shares of 1p value were issued to
ensure that the number of shares in issue was exactly divisible by
20. The share consolidation took place on 3 July 2014 and resulted
in the issued ordinary share capital totalling 41,061,412 shares of
1p each.
On 28 October 2014, the number of Ordinary Shares in issue
increased to 41,117,697 following the exercise of 56,285 share
options. The exercise of options raised net proceeds of £0.03
million.
Post Period Events
The Company's financial position was significantly strengthened
post the period under review. 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. Total gross proceeds of $39.3 million (£25.8 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.
SUMMARY
This has been an important period that leaves the Company well
positioned to deliver a number of key clinical development
milestones. Looking forward Summit expects to report top-line data
from our Phase 1b Modified Diet clinical trial of SMT C1100 in DMD
patients in the third quarter of 2015, and top-line data from the
Phase 2 proof of concept trial of SMT19969 in CDI in the second
half of 2015.
FINANCIAL
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CONSOLIDATED
STATEMENT OF COMPREHENSIVE INCOME (audited) |
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For the year ended 31
January 2015 |
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Year ended 31 January
2015 |
Year ended 31 January
2015 |
Year ended 31 January 2014 |
|
Note |
$000s |
£000s |
£000s |
|
|
|
|
|
Other operating income
(a) |
3 |
3,228 |
2,148 |
1,844 |
|
|
|
|
|
Operating expenses |
|
|
|
|
Research and development
(b) |
3 |
(15,653) |
(10,417) |
(6,611) |
General and
administration (b) |
3 |
(6,675) |
(4,442) |
(1,942) |
Total operating
expenses |
|
(22,328) |
(14,859) |
(8,553) |
|
|
|
|
|
Operating loss |
|
(19,100) |
(12,711) |
(6,709) |
|
|
|
|
|
Finance income |
|
77 |
51 |
9 |
|
|
|
|
|
Loss before income tax |
3 |
(19,023) |
(12,660) |
(6,700) |
|
|
|
|
|
Income tax |
|
1,949 |
1,297 |
607 |
Loss for the year |
|
(17,074) |
(11,363) |
(6,093) |
|
|
|
|
|
Loss for the year attributable
to owners of the parent |
|
(17,074) |
(11,363) |
(6,093) |
|
|
|
|
|
Other comprehensive
losses |
|
|
|
|
Exchange differences on translating
foreign operations |
|
93 |
62 |
-- |
Total comprehensive loss for
the year attributable to owners of the parent |
|
(16,981) |
(11,301) |
(6,093) |
Basic and diluted loss per
Ordinary Share from continuing operations (post consolidation and
subdivision) (c) |
|
(44)cents |
(29)pence |
(30)pence |
|
|
|
|
|
(a) As discussed in Note 2, the Group reclassified £1,375,000
from 'revenue' to 'other operating income' for the year ended 31
January 2014. This change had no effect on the Group's operating
loss or loss for that year. |
|
|
|
|
(b) The Group has reclassified costs previously disclosed
separately on the face of the Consolidated Statement of
Comprehensive Income to 'general and administration' and 'research
and development' expense lines as appropriate. See Note 3. |
|
|
|
|
(c)
Basic and diluted loss per Ordinary Share from continuing
operations have been adjusted retrospectively to reflect the effect
of the share consolidation and subdivision on 3 July 2014 (Note
4). |
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED
STATEMENT OF COMPREHENSIVE INCOME (unaudited) |
|
|
|
For the three months
ended 31 January 2015 |
|
|
|
|
Three months ended 31 January
2015 |
Three months ended 31 January
2015 |
Three months ended 31 January 2014 |
|
$000s |
£000s |
£000s |
|
|
|
|
Other operating income |
817 |
544 |
461 |
|
|
|
|
Operating expenses |
|
|
|
Research and
development |
(4,170) |
(2,775) |
(2,245) |
General and
administration |
(1,965) |
(1,308) |
(622) |
Total operating
expenses |
(6,135) |
(4,083) |
(2,867) |
|
|
|
|
Operating loss |
(5,318) |
(3,539) |
(2,406) |
|
|
|
|
Finance income |
15 |
10 |
2 |
|
|
|
|
Loss before income tax |
(5,303) |
(3,529) |
(2,404) |
|
|
|
|
Income tax |
780 |
519 |
128 |
Loss for the period |
(4,523) |
(3,010) |
(2,276) |
|
|
|
|
Loss for the period
attributable to owners of the parent |
(4,523) |
(3,010) |
(2,276) |
|
|
|
|
Other comprehensive
losses |
|
|
|
Exchange differences on translating
foreign operations |
81 |
54 |
-- |
Total comprehensive loss for
the period attributable to owners of the parent |
(4,442) |
(2,956) |
(2,276) |
Basic and diluted loss per
Ordinary Share from continuing operations (post consolidation and
subdivision) |
(11)cents |
(7)pence |
(10)pence |
|
|
|
|
|
|
|
|
CONSOLIDATED
STATEMENT OF FINANCIAL POSITION (audited) |
|
|
|
As at 31 January
2015 |
|
|
|
|
31 January 2015 |
31 January 2015 |
31 January 2014 |
|
$000s |
£000s |
£000s |
ASSETS |
|
|
|
Non-current assets |
|
|
|
Goodwill |
998 |
664 |
664 |
Intangible assets |
5,234 |
3,483 |
3,493 |
Property, plant and equipment |
83 |
55 |
43 |
|
6,315 |
4,202 |
4,200 |
Current assets |
|
|
|
Trade and other receivables |
3,952 |
2,630 |
431 |
Current tax |
1,952 |
1,299 |
634 |
Cash and cash equivalents |
16,927 |
11,265 |
2,030 |
|
22,831 |
15,194 |
3,095 |
|
|
|
|
Total assets |
29,146 |
19,396 |
7,295 |
|
|
|
|
LIABILITIES |
|
|
|
Non-current
liabilities |
|
|
|
Deferred tax |
(998) |
(664) |
(664) |
|
(998) |
(664) |
(664) |
Current
liabilities |
|
|
|
Trade and other payables |
(5,592) |
(3,721) |
(1,852) |
Provisions for other liabilities and
charges |
(68) |
(45) |
(17) |
|
(5,660) |
(3,766) |
(1,869) |
|
|
|
|
Total liabilities |
(6,658) |
(4,430) |
(2,533) |
|
|
|
|
Net assets |
22,488 |
14,966 |
4,762 |
|
|
|
|
EQUITY |
|
|
|
Share capital |
618 |
411 |
10,075 |
Share premium account |
36,214 |
24,101 |
40,177 |
Share-based payment reserve |
3,902 |
2,597 |
1,636 |
Merger reserve |
(2,920) |
(1,943) |
(1,943) |
Special reserve |
30,041 |
19,993 |
-- |
Currency translation reserve |
93 |
62 |
-- |
Accumulated losses reserve |
(45,460) |
(30,255) |
(45,183) |
Total equity attributable to
the equity shareholders of the Parent |
22,488 |
14,966 |
4,762 |
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED
STATEMENT OF CASH FLOWS (audited) |
|
|
|
|
For the year ended 31
January 2015 |
|
|
|
|
|
Note |
Year ended 31 January
2015 |
Year ended 31 January
2015 |
Year ended 31 January 2014 |
|
|
$000s |
£000s |
£000s |
Cash flows from operating
activities |
|
|
|
|
Loss before income tax |
3 |
(19,023) |
(12,660) |
(6,700) |
|
|
(19,023) |
(12,660) |
(6,700) |
|
|
|
|
|
Adjusted for: |
|
|
|
|
Finance income |
|
(77) |
(51) |
(9) |
Foreign exchange loss |
|
117 |
78 |
18 |
Depreciation |
|
35 |
23 |
17 |
Amortisation of intangible fixed assets |
|
15 |
10 |
9 |
Profit on disposal of property, plant and
equipment |
|
-- |
-- |
(14) |
Movement in provisions |
|
42 |
28 |
(133) |
Research and development expenditure
credit |
|
(59) |
(39) |
(29) |
Share-based payment |
|
1,444 |
961 |
226 |
Adjusted loss from operations before changes
in working capital and provisions |
|
(17,506) |
(11,650) |
(6,615) |
|
|
|
|
|
Increase in trade and other receivables |
|
(3,306) |
(2,200) |
(65) |
Increase in trade and other
payables |
|
2,806 |
1,867 |
465 |
Cash used by operations |
|
(18,006) |
(11,983) |
(6,215) |
|
|
|
|
|
Taxation received |
|
989 |
658 |
346 |
Net cash used in operating
activities |
|
(17,017) |
(11,325) |
(5,869) |
|
|
|
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
Proceeds from disposal of property, plant and
equipment |
|
-- |
-- |
102 |
Purchase of property, plant and
equipment |
|
(53) |
(35) |
(37) |
Purchase of intangible assets |
|
-- |
-- |
(10) |
Interest received |
|
77 |
51 |
9 |
Net cash generated by / (used
in) investing activities |
|
24 |
16 |
64 |
|
|
|
|
|
Financing activities |
|
|
|
|
Proceeds from issue of share capital |
|
33,057 |
22,000 |
4,663 |
Transaction costs on share capital
issued |
|
(2,227) |
(1,482) |
(207) |
Exercise of share
options |
|
39 |
26 |
-- |
Net cash generated from
financing activities |
|
30,869 |
20,544 |
4,456 |
|
|
|
|
|
Increase / (decrease) in cash and
cash equivalents |
|
13,876 |
9,235 |
(1,349) |
|
|
|
|
|
Cash and cash equivalents at
beginning of year |
|
3,051 |
2,030 |
3,379 |
|
|
|
|
|
Cash and cash equivalents at
end of year |
|
16,927 |
11,265 |
2,030 |
NOTES TO THE FINANCIAL STATEMENTS
For the year ended 31 January 2015
1. Basis of accounting
This financial information for the years ended 31 January 2015
and 31 January 2014 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 2015 and
those financial statements will be delivered to the Registrar of
Companies following the Company's 2015 Annual General Meeting.
Financial statements for the year ended 31 January 2014 have been
delivered to the Registrar of Companies. The auditors' reports on
the financial statements for the years ended 31 January 2015 and 31
January 2014 were unqualified and did not contain statements under
Section 498 of the Companies Act 2006. 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 financial statements have been prepared in accordance with
International Financial Reporting Standards ('IFRS') and
International Financial Reporting Interpretations Committee
('IFRIC') interpretations endorsed by the European Union and as
issued by the International Accounting Standards Board and with
those parts of the Companies Act 2006 applicable to companies
reporting under IFRS. The financial statements are prepared in
accordance with 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 2015 and 2014 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 2015 and in the Consolidated Income
Statement and Consolidated Cash Flow Statement for the year and 3
months ended 31 January 2015 have been translated into US dollars
at the rate on 30 January 2015 of $1.5026 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 6 May 2015.
2. Reclassification within the consolidated financial
statements
In the preparation of the financial statements the Group
determined £1,375,000 of income received in the year ended 31
January 2014 from philanthropic, non-government and not for profit
organisations and patient advocacy groups, including income
received from the Wellcome Trust, should be reclassified from
revenue to other operating income. As described below, in our
revised accounting policy for other operating income, we consider
that such arrangements are most similar to government grants and,
accordingly, this income is recognised as other operating income in
accordance with International Accounting Standard 20, "Accounting
for Government Grants and Disclosure of Government Assistance".
This change is considered immaterial to the Consolidated Financial
Statements taken as a whole and has no effect on the Group's
operating loss or loss for the year or for the comparative
period.
3. Loss
before income tax |
|
|
|
Year ended 31 January
2015 £000s |
Year ended 31 January
2014 Restated £000s |
Other operating income |
|
|
Income recognised in respect of the Wellcome
Trust |
1,169 |
1,375 |
Grant income (a) |
860 |
307 |
Other income (a) |
79 |
133 |
Research and development expenditure
credit |
40 |
29 |
|
2,148 |
1,844 |
Research and
development |
|
|
Employee benefit expense |
1,690 |
868 |
Share-based payment expense |
256 |
38 |
Programme related costs |
7,869 |
5,013 |
Amortisation of intangible assets |
10 |
9 |
Other research and development
costs |
592 |
683 |
|
10,417 |
6,611 |
General and
administration |
|
|
Employee benefit expense |
1,382 |
546 |
Share-based payment expense |
705 |
188 |
Foreign exchange (gain)/loss |
(91) |
18 |
Depreciation of property, plant and
equipment |
23 |
17 |
Operating lease rentals |
33 |
117 |
Other general and administration
costs |
2,390 |
1,056 |
|
4,442 |
1,942 |
(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 (formerly the Technology Strategy Board). The Group has
complied with all the conditions attached to these awards. |
|
|
|
|
|
|
|
|
4. Share capital |
|
|
|
Year ended 31 January
2015 £000s |
Year ended 31 January
2014 £000s |
Allotted, called up and fully
paid |
|
|
41,117,697 (2014: 482,766,686) Ordinary
Shares of 1p each |
411 |
4,828 |
Nil (2014: 524,702,133) Deferred Shares
of 1p each |
-- |
5,247 |
|
411 |
10,075 |
On 4 March 2014 the number or Ordinary Shares in issue increased
to 821,228,226 following the placing of 338,461,560 1p Ordinary
Shares. The equity placing raised net proceeds of £20.5
million.
On 3 July 2014, the shareholders approved a consolidation and
subdivision of the Company's share capital as part of a share
capital reorganisation. The capital reorganisation consisted of
three elements: a consolidation of every 20 existing Ordinary
Shares into one consolidated Ordinary Share followed by an
immediate subdivision of each of those Ordinary Shares into one new
Ordinary Share and 19 new Deferred Shares, and a capital reduction
to cancel the existing and new Deferred Shares together with a
reduction of the Company's Share Premium Account.
As part of the share consolidation on 3 July 2014 the number of
Ordinary Shares in issue increased to 821,228,240 following the
issue of 14 Ordinary Shares of 1p each. These new shares were
issued as part of the Capital Reorganisation to ensure the number
of shares in issue was exactly divisible by 20.
The consolidation and subdivision took place on 3 July 2014 and
resulted in the issued ordinary share capital of the Company
consisting of 41,061,412 Ordinary Shares of 1p each. The
cancellation of Deferred Shares and the reduction of the Company's
Share Premium Account took effect on 3 September 2014. At the same
time, the Company's Special Reserve was created and the Accumulated
Losses Reserve was reduced by £26.3 million which was the Company's
accumulated losses to 3 July 2014. The Special Reserve does not
represent realised profits of the Company and is treated as an
undistributable reserve under UK law. This determination might
change in future periods if and when allowed by UK law.
On 28 October 2014, the number of Ordinary Shares in issue
increased to 41,117,697 following the exercise of 56,285 share
options. The exercise of options raised net proceeds of £0.03
million.
All new Ordinary Shares issued rank pari passu with existing
Ordinary Shares.
5. Post Balance Sheet Events
Listing on the NASDAQ Global Market
A General Meeting of shareholders, held on 19 February 2015
approved the proposed US Initial Public offering of American
Depositary Shares ('ADSs') and listing on the NASDAQ Global
Market.
On 5 March 2015 the Group announced an Initial Public Offering
on the NASDAQ Global Market issuing 3,450,000 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. Each ADS represents five Ordinary Shares of 1p
each in the capital of the Company, thus 19,837,500 Ordinary Shares
were issued. Total gross proceeds of $39.3 million (£25.8 million)
were raised.
Following the US Initial Public Offering the number of Ordinary
Shares in issue was 60,955,197.
Share option exercise
On 23 March 2015, the number of Ordinary Shares in issue rose to
60,982,581 Ordinary Shares of 1p each following the exercise of
options over 27,384 shares. The issue of shares raised net proceeds
of £0.01 million.
All new Ordinary Shares rank pari passu with existing Ordinary
Shares.
Company name change
On 19 February 2015 the Company changed its name from Summit
Corporation plc to Summit Therapeutics plc.
Summit Therapeutics (NASDAQ:SMMT)
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