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 third quarter ended 31
October 2015.
Mr Glyn Edwards, Chief Executive Officer
of Summit commented: “We have recently announced positive
clinical trial results for both our lead programmes in DMD and CDI,
enabling us to advance these promising candidates to the next stage
of clinical development. In DMD, our lead utrophin modulator, SMT
C1100, is poised to enter a Phase 2 proof of concept trial after
demonstrating the ability to achieve exposure levels in patients
that we believe may be able to sustain utrophin production and
result in clinical benefit. Utrophin modulation has significant
promise as a disease-modifying therapy for all patients living with
DMD.
We also recently reported that in our Phase 2
trial in CDI that ridinilazole (SMT19969) achieved statistical
superiority over vancomycin in sustained clinical response in CDI,
a significant global healthcare threat. Ridinilazole has shown
great potential to address recurrent disease, the key clinical
issue in the treatment of CDI, and we look forward to evaluating
our options for advancing this novel class antibiotic into Phase 3
trials as quickly as possible.”
RECENT OPERATIONAL
HIGHLIGHTS
Utrophin Modulation Programme for
DMD:
SMT C1100 Highlights
- Phase 1b clinical trial in patients with DMD met primary
objective with dietary guidance increasing SMT C1100 absorption to
levels that may be able to sustain utrophin protein expression in
all patients
- SMT C1100 to progress into Phase 2 proof of concept clinical
trial
Utrophin Modulation Pipeline
- Nomination of multiple series of future generation utrophin
modulators for progression into lead optimisation studies as part
of exclusive strategic alliance with the University of Oxford
- Extension of strategic alliance with the University of Oxford
to support and accelerate the development of future generation
utrophin modulators
- New potential optimised formulations of SMT C1100 being
evaluated in a Phase 1 trial in healthy volunteers and patients
with DMD
CDI Programme:
Ridinilazole (SMT19969) Highlights
- Statistical superiority over vancomycin achieved in Phase 2
proof of concept clinical trial
- Primary endpoint met with sustained clinical response rate of
66.7% for ridinilazole compared to 42.4% for vancomycin
- Ridinilazole to advance into Phase 3 clinical development
Operational:
- Appointment of Dr Ralf Rosskamp as Chief Medical Officer in
September 2015
FINANCIAL HIGHLIGHTS
- Cash and cash equivalents at 31 October 2015 of £22.2 million
compared to £11.3 million at 31 January 2015
- Loss for the nine months ended 31 October 2015 of £12.1 million
compared to a loss of £8.4 million for the nine months ended 31
October 2014
For more information, please
contact:
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 / Tom Smale |
Tel: +44 (0)20 7496
3000 |
MacDougall
Biomedical Communications(US media contact)Chris
Erdman |
Tel: +1 781 235 3060
cerdman@macbiocom.com |
Peckwater
PR (Financial public relations, UK)Tarquin Edwards |
Tel: +44 (0)7879 458 364
tarquin.edwards@peckwaterpr.co.uk |
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SUMMIT OVERVIEW
Summit is seeking to treat all boys and young
men affected with the fatal disorder Duchenne muscular dystrophy
(‘DMD’) using its 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. This approach
therefore 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 robust pipeline of
first-, second- and future-generation product candidates. Summit is
preparing to advance its lead utrophin modulator, SMT C1100, into a
Phase 2 proof of concept clinical trial following the successful
completion of a Phase 1b modified diet clinical trial in patients
with DMD.
Summit’s CDI therapy is ridinilazole (SMT19969),
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 advancing into Phase 3
clinical development.
Duchenne Muscular Dystrophy: Utrophin
Modulation Programme
Summit’s most advanced utrophin modulator is SMT
C1100. It is an orally administered small molecule that is being
evaluated in patient clinical trials. SMT C1100 has received orphan
drug designation in the United States and Europe.
SMT C1100: Phase 1b Modified Diet Clinical Trial
In September 2015, Summit reported positive data from its Phase 1b
modified diet clinical trial of SMT C1100 in patients with DMD. The
clinical trial was designed to monitor the impact on absorption of
SMT C1100 in patients who followed a recommended diet with balanced
proportions of fat, proteins and carbohydrates, and combined 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 SMT C1100. All twelve
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.
SMT C1100: Phase 2 Proof of Concept TrialSMT
C1100 is now progressing into an open label Phase 2 proof of
concept clinical trial. This trial is expected to enrol up to 40
boys with DMD between the ages of five and ten years old at sites
in Europe and the United States. Planned endpoints are expected to
include changes in the fat content of muscle and in muscle
inflammation as measured by magnetic resonance imaging (‘MRI’) of
the leg muscles, and measurements of utrophin protein and muscle
fibre regeneration from muscle biopsies. It is planned that each
patient will have two muscle biopsies: one baseline biopsy and a
second biopsy either after 24- or 48-weeks of treatment. Functional
measures such as the six minute walk test and the North Star
Ambulatory Assessment will also be assessed throughout the
trial.
Summit has applied to the UK Medicines and
Healthcare Regulatory Authority for regulatory approval, and in
parallel is seeking consent from the UK Ethics Review Committee. It
is anticipated that the first patients will be enrolled and dosed
in early 2016. An investigational new drug (‘IND’) application is
also expected to be submitted to the US Food and Drug
Administration (‘FDA’) to enable the trial to enrol patients in the
United States.
Summit expects to report data from the first
group of patients enrolled in the trial periodically from the
second half of 2016 onwards, with the first set of 24-week muscle
biopsy data expected to be available before the end of 2016.
Utrophin Modulation Pipeline 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 SMT C1100 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. The data showed it increased
utrophin expression along the entire fibre length of slow- and
fast-twitch muscles to increase muscle stability, which resulted in
reduced regeneration and necrosis.
Summit also reported promising 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 to SMT C1100, for progression into lead
optimisation studies. This represented 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.
In addition to the current clinical development
of SMT C1100, Summit is working to identify a potential optimised
formulation of this drug. The Company is working with leading
formulation companies and two potential formulations are in a Phase
1 clinical trial. Each formulation has been evaluated in healthy
volunteers and the Company has selected one to be evaluated in
patients with DMD.
C. difficile Infection
Programme
CDI is a major healthcare threat with between
450,000 and 700,000 annual cases in the United States alone.
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 (SMT19969) is a novel
class antibiotic that has the potential to treat the initial
infection and to reduce the high rates of recurrent disease.
Ridinilazole has received Qualified Infectious Disease Product, or
QIDP, designation and has been granted Fast Track status from the
FDA.
Phase 2 Clinical ProgrammeIn November 2015,
Summit announced that ridinilazole displayed 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.
The Phase 2 trial 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 statistical superiority in SCR with ridinilazole was
driven by a large numerical reduction in recurrent disease compared
to vancomycin.
Ridinilazole was generally well tolerated and
the overall adverse event profiles of the two antibiotics 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. It is expected that
more detailed findings from this Phase 2 trial will be reported
during the first half of 2016.
An exploratory Phase 2 clinical trial evaluating
ridinilazole against the antibiotic fidaxomicin is currently
on-going 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 are
expected during the first half of 2016.
The development of ridinilazole has been
financially supported through to completion of this Phase 2
clinical trial milestone by Seeding Drug Discovery and
Translational Awards from the Wellcome Trust.
FINANCIAL REVIEW
Other Operating IncomeOther
operating income for the three months ended 31 October 2015 was
£0.4 million compared to £0.5 million for the three months ended 31
October 2014. Other operating income for the nine months ended 31
October 2015 was £1.2 million compared to £1.6 million for the nine
months ended 31 October 2014. Income recognised as part of the
Wellcome Trust Translational Award was lower in both the three
months ended 31 October 2015 and the nine months ended 31 October
2015 as a result of a lower contribution rate ascribed to Phase 2
clinical trial activities as compared to Phase 1 clinical trial
activities under the terms of the funding agreement. The Company
has received £3.9 million out of the £4.0 million awarded by the
Wellcome Trust to date. Income recognised as part of funding from
Innovate UK for the DMD programme was lower in the three months
ended 31 October 2105 and the nine months ended 31 October 2015, in
line with the achievement of milestones to date under the terms of
the funding agreement. The Company was awarded up to £2.4 million
in funding from Innovate UK and has received £1.6 million to
date.
Operating Expenses
Research and Development ExpensesResearch and
development expenses increased by £1.9 million to £4.5 million for
the three months ended 31 October 2015 from £2.6 million for the
three months ended 31 October 2014. Research and development
expenses increased by £4.2 million to £11.8 million for the nine
months ended 31 October 2015 from £7.6 million for the nine months
ended 31 October 2014. These increases reflected increased
expenditure related to the Company’s CDI and DMD programme
activities as well as an increase in staff related costs.
General and Administration ExpensesGeneral and
administration expenses increased by £0.7 million to £1.3 million
for the three months ended 31 October 2015 from £0.6 million for
the three months ended 31 October 2014. General and administration
expenses increased by £0.3 million to £3.4 million for the nine
months ended 31 October 2015 from £3.1 million for the nine months
ended 31 October 2014. The increases in both the three months ended
31 October 2015 and the nine months ended 31 October 2015 were
driven by costs associated with being a publicly traded company in
the US following the Company’s NASDAQ listing, as well as expenses
associated with maintaining the Company’s US office which opened in
2014. General and administration expenses in the nine months ended
31 October 2014 included a provision of £0.7 million for milestone
payments paid to two US DMD patient groups as part of funding
agreements recognised in July 2014.
Cash Flows
Operating Activities Net cash outflow from
operating activities increased by £3.6 million to £11.2 million for
the nine months ended 31 October 2015 compared to a net cash
outflow of £7.6 million for the nine months ended 31 October 2014.
The increase in net cash outflow was driven by an increase in
operating expenses and working capital requirements, offset by the
receipt of a research and development tax credit that increased by
£0.7 million to £1.4 million for the nine months ended 31 October
2015 from £0.7 million for the nine months ended 31 October
2014.
Investing Activities Net cash outflow from
investing activities for the nine months ended 31 October 2015 and
net cash inflow for the nine months ended 31 October 2014 includes
the net amount of bank interest received on cash deposits less
amounts paid to acquire property and equipment.
Financing Activities Net cash inflow from
financing activities for the nine months ended 31 October 2015 and
the nine months ended 31 October 2014 relate to proceeds received
from the sale of the Company’s equity securities and exercise of
share options, net of expenses. We received net proceeds of £22.1
million during the nine months ended 31 October 2015 compared with
net proceeds of £20.5 million during the nine months ended 31
October 2014.
|
|
|
|
|
Glyn
Edwards |
Erik Ostrowski |
|
|
Chief
Executive Officer |
Chief Financial Officer |
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16 December 2015
About Summit TherapeuticsSummit
is a biopharmaceutical company focused on the discovery,
development and commercialisation 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).
Forward Looking StatementsAny
statements in this press release about Summit’s future
expectations, plans and prospects, including but not limited to,
statements about the clinical and preclinical development of
Summit’s product candidates, the therapeutic potential of Summit’s
product candidates, the timing of initiation, completion and
availability of data from clinical trials and expectations
regarding the sufficiency of Summit’s 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
on-going 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 or preclinical studies will be indicative of
the results of later clinical trials, expectations for regulatory
approvals, availability of funding sufficient for Summit’s
foreseeable and unforeseeable operating expenses and capital
expenditure requirements and other factors discussed in the "Risk
Factors" section of filings that Summit makes with the Securities
and Exchange Commission including Summit’s Annual Report on Form
20-F for the fiscal year ended January 31, 2015. Accordingly
readers should not place undue reliance on forward looking
statements or information. In addition, any forward looking
statements included in this press release represent Summit’s views
only as of the date of this release and should not be relied upon
as representing Summit’s views as of any subsequent date. Summit
specifically disclaims any obligation to update any forward-looking
statements included in this press release.
Risks and UncertaintiesA
detailed analysis of the risks faced by Summit is set out in the
Company’s Annual Report on Form 20-F that was filed with the
Securities and Exchange Commission on 7 May 2015.
FINANCIAL STATEMENTS
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
(unaudited) For the three months ended 31 October 2015
|
|
Three months ended 31 October 2015 |
Three months ended 31 October 2015 |
Three months ended 31 October 2014 |
|
|
|
|
|
|
Note |
$000s |
£000s |
£000s |
|
|
|
|
|
Other operating
income |
|
|
576 |
|
|
373 |
|
|
460 |
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
Research and
development |
|
|
(6,953 |
) |
|
(4,502 |
) |
|
(2,596 |
) |
General and administration |
|
|
(2,009 |
) |
|
(1,301 |
) |
|
(639 |
) |
Total operating
expenses |
|
|
(8,962 |
) |
|
(5,803 |
) |
|
(3,235 |
) |
|
|
|
|
|
Operating
loss |
|
|
(8,386 |
) |
|
(5,430 |
) |
|
(2,775 |
) |
|
|
|
|
|
Finance
income |
|
|
12 |
|
|
8 |
|
|
16 |
|
|
|
|
|
|
Loss before
income tax |
|
|
(8,374 |
) |
|
(5,422 |
) |
|
(2,759 |
) |
|
|
|
|
|
Income tax |
|
|
1,175 |
|
|
761 |
|
|
312 |
|
Loss for the
period |
|
|
(7,199 |
) |
|
(4,661 |
) |
|
(2,447 |
) |
|
|
|
|
|
Loss for the period |
|
|
(7,199 |
) |
|
(4,661 |
) |
|
(2,447 |
) |
|
|
|
|
|
Other
comprehensive gains and losses |
|
|
|
|
Exchange differences on translating foreign operations |
|
|
(8 |
) |
|
(5 |
) |
|
11 |
|
Total comprehensive loss for the period |
|
|
(7,207 |
) |
|
(4,666 |
) |
|
(2,436 |
) |
Basic and diluted loss per ordinary share from continuing
operations (post consolidation and subdivision) |
2 |
(12)cents |
(8)pence |
(6)pence |
FINANCIAL STATEMENTS
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
(unaudited) For the nine months ended 31 October 2015
|
|
Nine months ended 31 October 2015 |
Nine months ended 31 October 2015 |
Nine months ended 31 October 2014 |
|
|
|
|
|
|
Note |
$000s |
£000s |
£000s |
|
|
|
|
|
Other operating
income |
|
|
1,866 |
|
|
1,208 |
|
|
1,604 |
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
Research and
development |
|
|
(18,316 |
) |
|
(11,859 |
) |
|
(7,642 |
) |
General and administration |
|
|
(5,217 |
) |
|
(3,378 |
) |
|
(3,134 |
) |
Total operating
expenses |
|
|
(23,533 |
) |
|
(15,237 |
) |
|
(10,776 |
) |
|
|
|
|
|
Operating
loss |
|
|
(21,667 |
) |
|
(14,029 |
) |
|
(9,172 |
) |
|
|
|
|
|
Finance
income |
|
|
37 |
|
|
24 |
|
|
41 |
|
|
|
|
|
|
Loss before
income tax |
|
|
(21,630 |
) |
|
(14,005 |
) |
|
(9,131 |
) |
|
|
|
|
|
Income tax |
|
|
3,004 |
|
|
1,945 |
|
|
778 |
|
Loss for the
period |
|
|
(18,626 |
) |
|
(12,060 |
) |
|
(8,353 |
) |
|
|
|
|
|
Loss for the period |
|
|
(18,626 |
) |
|
(12,060 |
) |
|
(8,353 |
) |
|
|
|
|
|
Other
comprehensive gains and losses |
|
|
|
|
Exchange differences on translating foreign operations |
|
|
(3 |
) |
|
(2 |
) |
|
8 |
|
Total comprehensive loss for the period |
|
|
(18,629 |
) |
|
(12,062 |
) |
|
(8,345 |
) |
Basic and diluted loss per ordinary share from continuing
operations (post consolidation and subdivision) |
2 |
(32)cents |
(21)pence |
(21)pence |
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
(unaudited)As at 31 October 2015
|
|
31 October 2015 |
31
October 2015 |
31 January 2015 |
|
Note |
$000s |
£000s |
£000s |
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
Goodwill |
|
|
1,026 |
|
|
664 |
|
|
664 |
|
Intangible assets |
|
|
5,369 |
|
|
3,476 |
|
|
3,483 |
|
Property,
plant and equipment |
|
|
128 |
|
|
83 |
|
|
55 |
|
|
|
|
6,523 |
|
|
4,223 |
|
|
4,202 |
|
Current
assets |
|
|
|
|
Prepayments and other
receivables |
|
|
1,767 |
|
|
1,143 |
|
|
2,630 |
|
Current tax |
|
|
2,910 |
|
|
1,884 |
|
|
1,299 |
|
Cash and
cash equivalents |
|
|
34,272 |
|
|
22,190 |
|
|
11,265 |
|
|
|
|
38,949 |
|
|
25,217 |
|
|
15,194 |
|
|
|
|
|
|
Total assets |
|
|
45,472 |
|
|
29,440 |
|
|
19,396 |
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
Non-current liabilities |
|
|
|
|
Deferred
tax |
|
|
(1,026 |
) |
|
(664 |
) |
|
(664 |
) |
|
|
|
(1,026 |
) |
|
(664 |
) |
|
(664 |
) |
Current liabilities |
|
|
|
|
Trade and other
payables |
|
|
(4,321 |
) |
|
(2,799 |
) |
|
(3,721 |
) |
Provisions for other liabilities and charges |
|
|
(102 |
) |
|
(66 |
) |
|
(45 |
) |
|
|
|
(4,423 |
) |
|
(2,865 |
) |
|
(3,766 |
) |
|
|
|
|
|
Total liabilities |
|
|
(5,449 |
) |
|
(3,529 |
) |
|
(4,430 |
) |
|
|
|
|
|
Net assets |
|
|
40,023 |
|
|
25,911 |
|
|
14,966 |
|
|
|
|
|
|
EQUITY |
|
|
|
|
Share capital |
3 |
|
947 |
|
|
613 |
|
|
411 |
|
Share premium
account |
3 |
|
71,101 |
|
|
46,035 |
|
|
24,101 |
|
Share-based payment
reserve |
|
|
5,356 |
|
|
3,468 |
|
|
2,597 |
|
Merger reserve |
|
|
(3,001 |
) |
|
(1,943 |
) |
|
(1,943 |
) |
Special reserve |
|
|
30,879 |
|
|
19,993 |
|
|
19,993 |
|
Currency translation
reserve |
|
|
93 |
|
|
60 |
|
|
62 |
|
Accumulated losses reserve |
|
|
(65,352 |
) |
|
(42,315 |
) |
|
(30,255 |
) |
Total equity attributable to the equity shareholders of the
Parent |
|
|
40,023 |
|
|
25,911 |
|
|
14,966 |
|
CONSOLIDATED STATEMENT OF CASH FLOWS
(unaudited) For the nine months ended 31 October 2015
|
|
Nine months ended 31 October 2015 |
Nine months ended 31 October 2015 |
Nine months ended 31 October 2014 |
|
|
$000s |
£000s |
£000s |
Cash flows from
operating activities |
|
|
|
|
Loss before income
tax |
|
|
(21,630 |
) |
|
(14,005 |
) |
|
(9,131 |
) |
|
|
|
(21,630 |
) |
|
(14,005 |
) |
|
(9,131 |
) |
|
|
|
|
|
Adjusted for: |
|
|
|
|
Finance income |
|
|
(37 |
) |
|
(24 |
) |
|
(41 |
) |
Foreign exchange (gain)
/ loss |
|
|
(15 |
) |
|
(10 |
) |
|
21 |
|
Depreciation |
|
|
42 |
|
|
27 |
|
|
16 |
|
Amortisation of
intangible fixed assets |
|
|
11 |
|
|
7 |
|
|
7 |
|
Movement in
provisions |
|
|
32 |
|
|
21 |
|
|
453 |
|
Research and
development expenditure credit |
|
|
(40 |
) |
|
(26 |
) |
|
(28 |
) |
Share-based payment expense |
|
|
1,347 |
|
|
871 |
|
|
701 |
|
Adjusted loss from
operations before changes in working capital |
|
|
(20,290 |
) |
|
(13,139 |
) |
|
(8,002 |
) |
|
|
|
|
|
Decrease / (Increase)
in prepayments and other receivables |
|
|
2,293 |
|
|
1,487 |
|
|
(907 |
) |
(Decrease) / Increase in trade and other payables |
|
|
(1,429 |
) |
|
(925 |
) |
|
672 |
|
Cash used by
operations |
|
|
(19,426 |
) |
|
(12,577 |
) |
|
(8,237 |
) |
|
|
|
|
|
Taxation
received |
|
|
2,164 |
|
|
1,401 |
|
|
658 |
|
Net cash used in operating activities |
|
|
(17,262 |
) |
|
(11,176 |
) |
|
(7,579 |
) |
|
|
|
|
|
|
|
|
|
|
Investing
activities |
|
|
|
|
Purchase of property, plant and equipment |
|
|
(91 |
) |
|
(59 |
) |
|
(23 |
) |
Interest received |
|
|
37 |
|
|
24 |
|
|
41 |
|
Net cash (used in) / generated by investing
activities |
|
|
(54 |
) |
|
(35 |
) |
|
18 |
|
|
|
|
|
|
Financing
activities |
|
|
|
|
Proceeds from issue of
share capital |
|
|
40,315 |
|
|
26,101 |
|
|
22,000 |
|
Transaction costs on
share capital issued |
|
|
(6,467 |
) |
|
(4,187 |
) |
|
(1,482 |
) |
Exercise of share
options |
|
|
341 |
|
|
222 |
|
|
26 |
|
Net cash generated from financing activities |
|
|
34,189 |
|
|
22,136 |
|
|
20,544 |
|
|
|
|
|
|
Increase in
cash and cash equivalents |
|
|
16,873 |
|
|
10,925 |
|
|
12,983 |
|
|
|
|
|
|
Cash and cash
equivalents at beginning of period |
|
|
17,399 |
|
|
11,265 |
|
|
2,030 |
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
|
34,272 |
|
|
22,190 |
|
|
15,013 |
|
CONSOLIDATED STATEMENT OF CHANGES IN
EQUITY (unaudited)
Nine months ended 31 October 2015
Group |
|
Share capital £000s |
Share premium account£000s |
Share-based payment reserve£000s |
Merger reserve£000s |
Special reserve £000s |
Currencytranslationadjustment£000s |
Accumulated losses£000s |
Total £000s |
At 1 February 2015 |
|
411 |
|
24,101 |
|
2,597 |
|
(1,943 |
) |
19,993 |
|
62 |
|
|
(30,255 |
) |
|
14,966 |
|
Loss for the period from continuing
operations |
|
- |
|
- |
|
- |
|
- |
|
- |
|
- |
|
|
(12,060 |
) |
|
(12,060 |
) |
Currency translation
adjustment |
|
- |
|
- |
|
- |
|
- |
|
- |
|
(2 |
) |
|
- |
|
|
(2 |
) |
Total comprehensive loss for the period |
|
- |
|
- |
|
- |
|
- |
|
- |
|
(2 |
) |
|
(12,060 |
) |
|
(12,062 |
) |
New share capital issued |
|
198 |
|
25,903 |
|
- |
|
- |
|
- |
|
- |
|
|
- |
|
|
26,101 |
|
Transaction costs on share capital issued |
|
- |
|
(4,187 |
) |
- |
|
- |
|
- |
|
- |
|
|
- |
|
|
(4,187 |
) |
Share options exercised |
|
4 |
|
218 |
|
- |
|
- |
|
- |
|
- |
|
|
- |
|
|
222 |
|
Share-based payment |
|
- |
|
- |
|
871 |
|
- |
|
- |
|
- |
|
|
- |
|
|
871 |
|
At 31 October 2015 |
|
613 |
|
46,035 |
|
3,468 |
|
(1,943 |
) |
19,993 |
|
60 |
|
|
(42,315 |
) |
|
25,911 |
|
Year ended 31 January 2015
Group |
|
Share capital £000s |
Share premium account£000s |
Share-based payment reserve£000s |
Merger reserve£000s |
Special reserve £000s |
Currencytranslationadjustment£000s |
Accumulated losses£000s |
Total £000s |
At 1 February 2014 |
|
|
10,075 |
|
|
40,177 |
|
1,636 |
|
(1,943 |
) |
|
- |
|
- |
|
(45,183 |
) |
|
4,762 |
|
Loss for the year from continuing
operations |
|
|
- |
|
|
- |
|
- |
|
- |
|
|
- |
|
- |
|
(11,363 |
) |
|
(11,363 |
) |
Currency translation
adjustment |
|
|
- |
|
|
- |
|
- |
|
- |
|
|
- |
|
62 |
|
- |
|
|
62 |
|
Total comprehensive loss for the year |
|
|
- |
|
|
- |
|
- |
|
- |
|
|
- |
|
62 |
|
(11,363 |
) |
|
(11,301 |
) |
New share capital issued |
|
|
3,384 |
|
|
18,616 |
|
- |
|
- |
|
|
- |
|
- |
|
- |
|
|
22,000 |
|
Transaction costs on share capital issued |
|
|
- |
|
|
(1,482 |
) |
- |
|
- |
|
|
- |
|
- |
|
- |
|
|
(1,482 |
) |
Cancellation of deferred shares |
|
|
(13,048 |
) |
|
- |
|
- |
|
- |
|
|
13,048 |
|
- |
|
- |
|
|
- |
|
Reduction of share premium account |
|
|
- |
|
|
(33,236 |
) |
- |
|
- |
|
|
33,236 |
|
- |
|
- |
|
|
- |
|
Elimination of losses |
|
|
- |
|
|
- |
|
- |
|
- |
|
|
(26,291 |
) |
- |
|
26,291 |
|
|
- |
|
Share options exercised |
|
|
- |
|
|
26 |
|
- |
|
- |
|
|
- |
|
- |
|
- |
|
|
26 |
|
Share-based payment |
|
|
- |
|
|
- |
|
961 |
|
- |
|
|
- |
|
- |
|
- |
|
|
961 |
|
At 31 January 2015 |
|
|
411 |
|
|
24,101 |
|
2,597 |
|
(1,943 |
) |
|
19,993 |
|
62 |
|
(30,255 |
) |
|
14,966 |
|
Nine months ended 31 October 2014
Group |
|
Share capital £000s |
Share premium account£000s |
Share-based payment reserve£000s |
Merger reserve£000s |
Special reserve £000s |
Currencytranslationadjustment£000s |
Accumulated losses£000s |
Total £000s |
At 1 February 2014 |
|
|
10,075 |
|
|
40,177 |
|
1,636 |
|
(1,943 |
) |
|
- |
|
- |
|
(45,183 |
) |
|
4,762 |
|
Loss for the year from continuing operations |
|
|
- |
|
|
- |
|
- |
|
- |
|
|
- |
|
- |
|
(8,353 |
) |
|
(8,353 |
) |
Currency translation
adjustment |
|
|
- |
|
|
- |
|
- |
|
- |
|
|
- |
|
8 |
|
- |
|
|
8 |
|
Total comprehensive loss for the year |
|
|
- |
|
|
- |
|
- |
|
- |
|
|
- |
|
8 |
|
(8,353 |
) |
|
(8,345 |
) |
New share capital issued |
|
|
3,384 |
|
|
18,616 |
|
- |
|
- |
|
|
- |
|
- |
|
- |
|
|
22,000 |
|
Transaction costs on share capital issued |
|
|
- |
|
|
(1,482 |
) |
- |
|
- |
|
|
- |
|
- |
|
- |
|
|
(1,482 |
) |
Cancellation of deferred shares |
|
|
(13,048 |
) |
|
- |
|
- |
|
- |
|
|
13,048 |
|
- |
|
- |
|
|
- |
|
Reduction of share premium account |
|
|
- |
|
|
(33,236 |
) |
- |
|
- |
|
|
33,236 |
|
- |
|
- |
|
|
- |
|
Elimination of losses |
|
|
- |
|
|
- |
|
- |
|
- |
|
|
(26,291 |
) |
- |
|
26,291 |
|
|
- |
|
Share options exercised |
|
|
- |
|
|
26 |
|
- |
|
- |
|
|
- |
|
- |
|
- |
|
|
26 |
|
Share-based payment |
|
|
- |
|
|
- |
|
701 |
|
- |
|
|
- |
|
- |
|
- |
|
|
701 |
|
At 31 October 2014 |
|
|
411 |
|
|
24,101 |
|
2,337 |
|
(1,943 |
) |
|
19,993 |
|
8 |
|
(27,245 |
) |
|
17,662 |
|
NOTES TO THE FINANCIAL STATEMENTSFor the three
and nine months ended 31 October 2015
1. Basis of accounting
The unaudited consolidated interim financial
statements of Summit and its subsidiaries (the ‘Group’) for the
three months and nine months ended 31 October 2015 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 including those
applicable to accounting periods ending 31 January 2016 and the
accounting policies set out in Summit’s consolidated financial
statements. They do not include all the statements required for
full annual financial statements, and should be read in conjunction
with the consolidated financial statements of the Group as at 31
January 2015. The interim financial statements are prepared in
accordance with the historical cost convention. Whilst the
financial information included in this 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.
The interim financial statements have been
prepared on a going concern basis. Management, having reviewed the
future operating costs of the business in conjunction with the cash
held at 31 October 2015, believes the Group has sufficient funds to
continue as a going concern for the foreseeable future.
The financial information for the three month
and nine month periods ended 31 October 2015 and 2014 is
unaudited.
The interim financial statements are not the
Company’s statutory accounts. The Company’s statutory accounts for
the year ended 31 January 2015 in which the Company’s auditors made
an unqualified report have been filed with the Registrar of
Companies England and Wales.
Solely for the convenience of the reader, unless
otherwise indicated, all pound sterling amounts stated in the
Consolidated Balance Sheet as at 31 October 2015, in the
Consolidated Income Statement for the three and nine months ended
31 October 2015 and in the Consolidated Cash Flow Statement for the
nine months ended 31 October 2015 have been translated into US
dollars at the rate on 31 October 2015 of $1.5445 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 16 December 2015.
2. Loss per ordinary share
calculation
The loss per ordinary share has been calculated
by dividing the loss for the period by the weighted average number
of ordinary shares in issue during the nine month period to 31
October 2015: 58,354,036 and during the three month period to 31
October 2015: 61,290,740 (for the nine month period to 31 October
2014: 39,510,817, for the three month period to 31 October 2014:
40,412,841).
Since the Group has reported a net loss, diluted
loss per ordinary share is equal to basic loss per ordinary
share.
3. Issue of share capital
In March 2015, 3,967,500 American Depository
Shares (‘ADSs’) were issued at a price of $9.90 per ADS as part of
the Company’s initial public offering on the NASDAQ Global Market.
Each ADS represents five ordinary shares of 1 penny each in the
capital of the Company.
During the nine months ended 31 October 2015,
335,543 new ordinary shares were issued following various exercises
of share options which generated gross proceeds of £0.2
million.
The number of ordinary shares in issue at the
end of the period was 61,290,740. All new ordinary shares rank pari
passu with existing ordinary shares.
- END -
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