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 first quarter ended 30
April 2016.
Mr Glyn Edwards, Chief Executive Officer
of Summit commented: “Our programmes in DMD and CDI both
have the potential to significantly improve the current standards
of care and are making good progress towards the patients who could
benefit from their unique mechanisms of action. With the IND
clearance for the expansion of PhaseOut DMD into the US, we are on
track to announce initial data that could potentially demonstrate
the mechanism of ezutromid and utrophin modulation in patients with
DMD in January 2017.
“In CDI, data from our Phase 2 CoDIFy trial
continue to support ridinilazole as a novel, highly selective
antibiotic that could greatly reduce recurrent disease. As this
programme advances to Phase 3, we are exploring potential
partnerships to leverage the most value for patients, shareholders
and our Company.”
HIGHLIGHTS
Utrophin Modulation Programme for DMD
Ezutromid (formerly SMT C1100) Highlights
- 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
- IND cleared by FDA allowing expansion of PhaseOut DMD with
enrolment of patients into US sites expected in Q3 2016
- Positive interim data reported from Phase 1 clinical trial
testing new formulation of ezutromid
Utrophin Modulator Pipeline: Future Generation Development
- Publication on the development of biomarkers to quantify
utrophin protein and regeneration of muscle fibres
Utrophin R&D Day
- Event featuring three key opinion leaders in DMD, to be held on
15 June 2016 in New York City
CDI Programme
Ridinilazole (formerly SMT19969) Highlights
- Ridinilazole markedly reduced recurrence rates and had a
statistically superior rate of sustained clinical response (‘SCR’)
in CoDIFy Phase 2 clinical trial compared to vancomycin
- Gut microbiome preserved in ridinilazole treated patients while
vancomycin inflicted substantial and long-lasting damage in CoDIFy
Phase 2 clinical trial
- Ridinilazole being prepared to enter Phase 3 clinical
trials
- Grant of key patent in the US protecting ridinilazole
Financial Highlights
- Cash and cash equivalents at 30 April 2016 of £10.0 million
compared to £16.3 million at 31 January 2016
- Loss for the three months ended 30 April 2016 of £5.2 million
compared to a loss of £3.4 million for the three months ended 30
April 2015
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:
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 |
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, including our Annual Report on Form 20-F for the fiscal
year ended 31 January 2016. 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.
OPERATIONAL REVIEW
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’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.
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 markedly reduced recurrence rates and had a
statistically superior rate of sustained clinical response (‘SCR’)
compared to vancomycin. Ridinilazole is now being prepared for
Phase 3 clinical trials. Ridinilazole has received Qualified
Infectious Disease Product, or QIDP, designation and has been
granted Fast Track designation by the US Food and Drug
Administration (‘FDA’).
Duchenne Muscular Dystrophy: Utrophin
Modulation Programme
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. In late April 2016, the FDA
cleared the investigational new drug application for ezutromid and
enrolment into PhaseOut DMD at trial sites in the United States is
expected to start 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 heathy 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.
Utrophin Modulator Pipeline and Biomarker
DevelopmentAs 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 molecules are structurally
related to ezutromid, but are designed to have more favourable
pharmaceutical properties to achieve higher plasma levels of drug.
Future generation molecules will likely be structurally distinct
from ezutromid and second-generation molecules.
In March 2016, research was published in the
peer reviewed journal PLoS ONE on the development of imaging
techniques designed to quantify utrophin protein and muscle fibre
regeneration in muscle biopsies from patients with DMD and Becker
muscular dystrophy (‘BMD’), a milder form of muscular dystrophy.
The developed assays allowed the absolute quantification of
regenerating muscle fibres within a biopsy section and, for the
first time, the researchers observed a correlation between the
percentage of regenerating muscle fibres with differences in
clinical severity between patients with DMD and BMD from whom the
biopsy was taken.
Utrophin R&D DaySummit will host a Utrophin
R&D Day on 15 June 2016 in New York City. The event is open to
analysts, institutional investors and members of the press and will
feature presentations from three key opinion leaders in DMD
alongside management. For more information, email
investors@summitplc.com.
C. difficile Infection
Programme
Phase 2 CoDIFy Clinical TrialDuring the first
quarter of the fiscal year, further data were reported from a Phase
2 proof of concept clinical trial of ridinilazole called 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 showed 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. Additional
data from this trial are to be reported at the 2016 ASM Microbe
conference which will be held June 16-20 in Boston, US.
In light of these positive data from CoDIFy, the
Company is exploring 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 Europe and the US. The results from this open label
trial are expected to help inform the design of future Phase 3
clinical trials and the commercial positioning of ridinilazole.
Top-line results from this trial are expected in the second half of
2016.
Preclinical ActivitiesIn 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.
Patent GrantA composition of matter patent
covering ridinilazole was granted by the United States Patent and
Trademark Office in April 2016. The patent (United States Patent
9,314,456) is entitled ‘Antibacterial Compounds’ and provides a
period of exclusivity for ridinilazole in the United States until
at least 1 December 2029, with the possibility of patent term
extension.
The development of ridinilazole has been
financially supported by Seeding Drug Discovery and Translational
Awards from the Wellcome Trust.
FINANCIAL REVIEW
Other Operating Income
Other operating income for the three months
ended 30 April 2016 was £0.06 million compared to £0.4 million for
the three months ended 30 April 2015. Income recognised as part of
the Wellcome Trust Translational Award decreased by £0.2 million to
£650 for the three months ended 30 April 2016 from £0.2 million for
the three months ended 30 April 2015. As of 30 April 2016, we had
an accrued income balance of £0.1 million related to cash due to be
received from the Wellcome Trust, which we expect to receive within
the next twelve months upon achievement of the final milestone of
the Wellcome Trust Award when we deliver final reports related to
the grant. Income recognized as part of the funding from Innovate
UK for the DMD programme decreased by £0.1 million to
£0.06 million for the three months ended 30 April 2016 from
£0.2 million for the three months ended 30 April 2015. The
decrease in income is in line with the achievement of milestones to
date under the funding agreement.
Operating Expenses
Research and Development ExpensesResearch and
development expenses increased by £1.7 million to £4.8 million for
the three months ended 30 April 2016 from £3.1 million for the
three months ended 30 April 2015. This increase was primarily due
to increased investment in our DMD programme which increased by
£1.1 million to £2.3 million from £1.2 million for the three months
ended 30 April 2015, and a £0.6 million increase in research and
development related staffing costs driven by an increase in
headcount.
General and Administration ExpensesGeneral and
administration expenses increased by £0.3 million to £1.4 million
for the three months ended 30 April 2016 from £1.1 million for the
three months ended 30 April 2015. This increase was primarily due
to additional corporate costs of £0.3 million associated with being
a publicly traded company in the United States as well as in the
United Kingdom and a £0.2 million increase in staff related costs
offset by a £0.2 million favourable exchange rate variance.
Cash Flows
Operating ActivitiesNet cash used by operating
activities increased by £2.5 million to £6.4 million for the three
months ended 30 April 2016 compared to £3.9 million for the three
months ended 30 April 2015. This increase was driven by an increase
in research and development expenditure and an increase in working
capital requirements of £0.3 million.
Investing ActivitiesNet cash used in investing
activities for the three months ended 30 April 2016 and the three
months ended 30 April 2015 includes the net amount of bank interest
received on cash deposits less amounts paid to acquire property,
plant and equipment.
Financing ActivitiesNet cash inflow from
financing activities for the three months ended 30 April 2016
relates to proceeds of £0.1 million received following the exercise
of warrants on 14 April 2016. For the three months ended 30 April
2015 the Company received net proceeds of £22.0 million from the
sale of equity securities.
Headcount
Average headcount for the three months ended 30
April 2016 was 37 (30 April 2015: 25).
Financial Position
As at 30 April 2016, total cash and cash equivalents held were
£10.0 million (31 January 2016: £16.3 million)
Glyn Edwards, |
Erik
Ostrowski, |
Chief Executive Officer |
Chief Financial Officer |
FINANCIAL STATEMENTS
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
(unaudited) For the three months ended 30 April 2016
|
|
Threemonths ended 30 April 2016 |
Threemonths ended 30 April 2016 |
Threemonths ended 30 April 2015 |
|
Note |
$000s |
£000s |
£000s |
|
|
|
|
|
Other operating
income |
|
|
87 |
|
|
59 |
|
|
408 |
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
Research and
development |
|
|
(7,048 |
) |
|
(4,806 |
) |
|
(3,133 |
) |
General and administration |
|
|
(2,100 |
) |
|
(1,432 |
) |
|
(1,075 |
) |
Total operating
expenses |
|
|
(9,148 |
) |
|
(6,238 |
) |
|
(4,208 |
) |
|
|
|
|
|
Operating
loss |
|
|
(9,061 |
) |
|
(6,179 |
) |
|
(3,800 |
) |
|
|
|
|
|
Finance
income |
|
|
5 |
|
|
3 |
|
|
7 |
|
|
|
|
|
|
Loss before
income tax |
|
|
(9,056 |
) |
|
(6,176 |
) |
|
(3,793 |
) |
|
|
|
|
|
Income tax |
|
|
1,372 |
|
|
935 |
|
|
427 |
|
Loss for the
period |
|
|
(7,684 |
) |
|
(5,241 |
) |
|
(3,366 |
) |
|
|
|
|
|
Loss for the period |
|
|
(7,684 |
) |
|
(5,241 |
) |
|
(3,366 |
) |
|
|
|
|
|
Other
comprehensive (losses) / income |
|
|
|
|
Exchange differences on translating foreign operations |
|
|
(8 |
) |
|
(5 |
) |
|
15 |
|
Total comprehensive loss for the period |
|
|
(7,692 |
) |
|
(5,246 |
) |
|
(3,351 |
) |
Basic and diluted loss per Ordinary Share from continuing
operations |
2 |
(13)cents |
(9)pence |
(6)pence |
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
(unaudited) As at 30 April 2016
|
|
30 April2016 |
30
April 2016 |
31 January2016 |
|
|
$000s |
£000s |
£000s |
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
Goodwill |
|
|
974 |
|
|
664 |
|
|
664 |
|
Intangible assets |
|
|
5,096 |
|
|
3,475 |
|
|
3,473 |
|
Property,
plant and equipment |
|
|
114 |
|
|
78 |
|
|
83 |
|
|
|
|
6,184 |
|
|
4,217 |
|
|
4,220 |
|
Current
assets |
|
|
|
|
Prepayments and other
receivables |
|
|
2,998 |
|
|
2,044 |
|
|
1,538 |
|
Current tax |
|
|
5,796 |
|
|
3,952 |
|
|
3,014 |
|
Cash and
cash equivalents |
|
|
14,650 |
|
|
9,989 |
|
|
16,304 |
|
|
|
|
23,444 |
|
|
15,985 |
|
|
20,856 |
|
|
|
|
|
|
Total assets |
|
|
29,628 |
|
|
20,202 |
|
|
25,076 |
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
Non-current
liabilities |
|
|
|
|
Provisions for other
liabilities and charges |
|
|
(117 |
) |
|
(80 |
) |
|
(73 |
) |
Deferred tax
liability |
|
|
(973 |
) |
|
(664 |
) |
|
(664 |
) |
|
|
|
(1,090 |
) |
|
(744 |
) |
|
(737 |
) |
Current liabilities |
|
|
|
|
Trade and other
payables |
|
|
(4,588 |
) |
|
(3,128 |
) |
|
(3,206 |
) |
|
|
|
(4,588 |
) |
|
(3,128 |
) |
|
(3,206 |
) |
|
|
|
|
|
Total liabilities |
|
|
(5,678 |
) |
|
(3,872 |
) |
|
(3,943 |
) |
|
|
|
|
|
Net assets |
|
|
23,950 |
|
|
16,330 |
|
|
21,133 |
|
|
|
|
|
|
EQUITY |
|
|
|
|
Share capital |
|
|
901 |
|
|
615 |
|
|
613 |
|
Share premium
account |
|
|
67,668 |
|
|
46,140 |
|
|
46,035 |
|
Share-based payment
reserve |
|
|
6,002 |
|
|
4,093 |
|
|
3,757 |
|
Merger reserve |
|
|
(2,849 |
) |
|
(1,943 |
) |
|
(1,943 |
) |
Special reserve |
|
|
29,322 |
|
|
19,993 |
|
|
19,993 |
|
Currency translation
reserve |
|
|
24 |
|
|
16 |
|
|
21 |
|
Accumulated losses reserve |
|
|
(77,118 |
) |
|
(52,584 |
) |
|
(47,343 |
) |
Total
equity |
|
|
23,950 |
|
|
16,330 |
|
|
21,133 |
|
CONSOLIDATED STATEMENT OF CASH FLOWS
(unaudited) For the three months ended 30 April 2016
|
|
Threemonthsended April 2016 |
Threemonthsended April 2016 |
Threemonthsended April 2015 |
|
|
$000s |
£000s |
£000s |
Cash flows from
operating activities |
|
|
|
|
Loss before income
tax |
|
|
(9,056 |
) |
|
(6,176 |
) |
|
(3,793 |
) |
|
|
|
(9,056 |
) |
|
(6,176 |
) |
|
(3,793 |
) |
|
|
|
|
|
Adjusted for: |
|
|
|
|
Finance income |
|
|
(4 |
) |
|
(3 |
) |
|
(7 |
) |
Foreign exchange
loss |
|
|
66 |
|
|
45 |
|
|
2 |
|
Depreciation |
|
|
16 |
|
|
11 |
|
|
9 |
|
Amortisation of
intangible fixed assets |
|
|
3 |
|
|
2 |
|
|
2 |
|
Movement in
provisions |
|
|
10 |
|
|
7 |
|
|
6 |
|
Research and
development expenditure credit |
|
|
(4 |
) |
|
(3 |
) |
|
(16 |
) |
Share-based payment |
|
|
493 |
|
|
336 |
|
|
236 |
|
Adjusted loss from
operations before changes in working capital |
|
|
(8,478 |
) |
|
(5,781 |
) |
|
(3,561 |
) |
|
|
|
|
|
(Increase) / decrease
in trade and other receivables |
|
|
(746 |
) |
|
(509 |
) |
|
712 |
|
Decrease
in trade and other payables |
|
|
(114 |
) |
|
(78 |
) |
|
(1,015 |
) |
Cash used by
operations |
|
|
(9,338 |
) |
|
(6,368 |
) |
|
(3,864 |
) |
Taxation
received |
|
|
- |
|
|
- |
|
|
- |
|
Net cash used in operating activities |
|
|
(9,338 |
) |
|
(6,368 |
) |
|
(3,864 |
) |
|
|
|
|
|
|
|
|
|
|
Investing
activities |
|
|
|
|
Purchase of property, plant and equipment |
|
|
(10 |
) |
|
(7 |
) |
|
(17 |
) |
Interest received |
|
|
4 |
|
|
3 |
|
|
7 |
|
Net cash used in investing activities |
|
|
(6 |
) |
|
(4 |
) |
|
(10 |
) |
|
|
|
|
|
Financing
activities |
|
|
|
|
Proceeds from issue of
share capital |
|
|
157 |
|
|
107 |
|
|
26,102 |
|
Transaction costs on
share capital issued |
|
|
- |
|
|
- |
|
|
(4,092 |
) |
Exercise of share
options |
|
|
- |
|
|
- |
|
|
13 |
|
Net cash generated from financing activities |
|
|
157 |
|
|
107 |
|
|
22,023 |
|
|
|
|
|
|
(Decrease) /
increase in cash and cash equivalents |
|
|
(9,187 |
) |
|
(6,265 |
) |
|
18,149 |
|
|
|
|
|
|
Effect of
exchange rates in cash and cash equivalents |
|
|
(74 |
) |
|
(50 |
) |
|
- |
|
|
|
|
|
|
Cash and cash
equivalents at beginning of the period |
|
|
23,911 |
|
|
16,304 |
|
|
11,265 |
|
|
|
|
|
|
Cash and cash equivalents at end of the
period |
|
|
14,650 |
|
|
9,989 |
|
|
29,414 |
|
CONSOLIDATED STATEMENT OF CHANGES IN
EQUITY (unaudited)
Three months ended 30 April 2016
Group |
|
Sharecapital£000s |
Sharepremiumaccount£000s |
Share-basedpaymentreserve£000s |
Mergerreserve£000s |
Specialreserve£000s |
Currencytranslationreserve£000s |
Accumulatedlossesreserve£000s |
Total £000s |
At 1 February 2016 |
|
613 |
46,035 |
3,757 |
|
(1,943 |
) |
19,993 |
|
21 |
|
|
(47,343 |
) |
|
21,133 |
|
Loss for the period from continuing
operations |
|
- |
- |
- |
|
- |
|
- |
|
- |
|
|
(5,241 |
) |
|
(5,241 |
) |
Currency translation
adjustment |
|
- |
- |
- |
|
- |
|
- |
|
(5 |
) |
|
- |
|
|
(5 |
) |
Total comprehensive loss for the period |
|
- |
- |
- |
|
- |
|
- |
|
(5 |
) |
|
(5,241 |
) |
|
(5,246 |
) |
New share capital issued |
|
2 |
105 |
- |
|
- |
|
- |
|
- |
|
|
- |
|
|
107 |
|
Share-based payment |
|
- |
- |
336 |
|
- |
|
- |
|
- |
|
|
- |
|
|
336 |
|
At 30 April 2016 |
|
615 |
46,140 |
4,093 |
|
(1,943 |
) |
19,993 |
|
16 |
|
|
(52,584 |
) |
|
16,330 |
|
Year ended 31 January 2016
Group |
|
Sharecapital£000s |
Sharepremiumaccount£000s |
Share-basedpaymentreserve£000s |
Mergerreserve£000s |
Specialreserve£000s |
Currencytranslationadjustment£000s |
Accumulatedlossesreserve£000s |
Total £000s |
At 1 February 2015 |
|
411 |
|
24,101 |
|
2,597 |
|
(1,943 |
) |
19,993 |
|
62 |
|
|
(30,255 |
) |
|
14,966 |
|
Loss for the year from continuing operations |
|
- |
|
- |
|
- |
|
- |
|
- |
|
- |
|
|
(17,088 |
) |
|
(17,088 |
) |
Currency translation
adjustment |
|
- |
|
- |
|
- |
|
- |
|
- |
|
(41 |
) |
|
- |
|
|
(41 |
) |
Total comprehensive loss for the year |
|
- |
|
- |
|
- |
|
- |
|
- |
|
(41 |
) |
|
(17,088 |
) |
|
(17,129 |
) |
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 |
|
- |
|
- |
|
1,160 |
|
- |
|
- |
|
- |
|
|
- |
|
|
1,160 |
|
At 31 January 2016 |
|
613 |
|
46,035 |
|
3,757 |
|
(1,943 |
) |
19,993 |
|
21 |
|
|
(47,343 |
) |
|
21,133 |
|
Three months ended 30 April 2015
Group |
|
Sharecapital£000s |
Sharepremiumaccount£000s |
Share-basedpaymentreserve£000s |
Mergerreserve£000s |
Specialreserve£000s |
Currencytranslationadjustment£000s |
Accumulatedlosses£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 |
|
- |
|
- |
|
- |
|
- |
|
- |
- |
|
(3,366 |
) |
|
(3,366 |
) |
Currency translation
adjustment |
|
- |
|
- |
|
- |
|
- |
|
- |
15 |
|
- |
|
|
15 |
|
Total comprehensive loss for the period |
|
- |
|
- |
|
- |
|
- |
|
- |
15 |
|
(3,366 |
) |
|
(3,351 |
) |
New share capital issued |
|
198 |
|
25,903 |
|
- |
|
- |
|
- |
- |
|
- |
|
|
26,101 |
|
Transaction costs on share capital issued |
|
- |
|
(4,092 |
) |
- |
|
- |
|
- |
- |
|
- |
|
|
(4,092 |
) |
Share options exercised |
|
- |
|
13 |
|
- |
|
- |
|
- |
- |
|
- |
|
|
13 |
|
Share-based payment |
|
- |
|
- |
|
236 |
|
- |
|
- |
- |
|
- |
|
|
236 |
|
At 30 April 2015 |
|
609 |
|
45,925 |
|
2,833 |
|
(1,943 |
) |
19,993 |
77 |
|
(33,621 |
) |
|
33,873 |
|
NOTES TO THE FINANCIAL STATEMENTS For the
three months ended 30 April 2016
1. Basis of accounting
The unaudited consolidated interim financial
statements of Summit and its subsidiaries (the ‘Group’) for the
three months ended 30 April 2016 have been prepared in accordance
with International Financial Reporting Standards (‘IFRS’) and
International Financial Reporting Interpretations Committee
(‘IFRIC’) interpretations as issued by the International Accounting
Standards Board and as adopted by the European Union and with those
parts of the Companies Act 2006 applicable to companies reporting
under IFRS including those applicable to accounting periods ending
31 January 2017 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 2016 (the ‘2016
Accounts’). The 2016 Accounts, on which the Company’s auditors
delivered an unqualified audit report will be delivered to the
Register of Companies following the 2016 Annual General Meeting.
The 2016 Accounts also contain a statement from the auditors
drawing shareholders’ attention to the Group’s need to raise
additional capital as noted below.
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 as issued by the International
Accounting Standards Board and adopted for use in the European
Union, this announcement does not itself contain sufficient
information to comply with IFRSs.
The interim 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 for the three month
periods ended 30 April 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 30 April 2016 and in the
Consolidated Income Statement and Consolidated Cash Flow Statement
for the three months ended 30 April 2016 have been translated into
US dollars at the rate on 30 April 2016 of $1.4666 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 2 June 2016.
2. Loss per share calculation
The loss per Ordinary Share has been calculated
by dividing the loss for the period by the weighted average number
of shares in issue during the three month period to 30 April 2016:
61,324,182 (for the three month period to 30 April 2015:
52,391,028).
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
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 shares raised net proceeds of £106,227. All new
Ordinary Shares rank pari passu with existing Ordinary Shares.
- END -
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