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 second quarter and half
year ended 31 July 2016.
Mr Glyn Edwards, Chief Executive Officer
of Summit commented: “During the first half of the year,
our DMD programme has continued to gain momentum. We initiated our
Phase 2 proof of concept clinical trial, PhaseOut DMD, of ezutromid
and are actively enrolling patients in the UK. This trial
represents the first long-term clinical trial of a utrophin
modulator, a potential disease-modifying therapy applicable to all
patients with DMD. We look forward to receiving data from the first
group of 24-week biopsies in Q2/Q3 2017.
“We also announced results from a Phase 1 trial
in DMD patients that showed a new formulation of ezutromid achieved
over a six-fold increase in maximum plasma levels but with a
reduced oral dose compared to the current formulation. With these
results, we plan to incorporate the new formulation, subject to
regulatory approval, into PhaseOut DMD alongside the current
formulation. Including both formulations allows us to further
explore the potential therapeutic effect of ezutromid with an
expanded range of blood concentrations.
“In our CDI programme, additional results from
our Phase 2 CoDIFy clinical trial support ridinilazole as a highly
selective, microbiome-sparing antibiotic that has great promise in
both the treatment of the initial infection and in reducing CDI
recurrences, the key issue in the treatment of CDI. We continue to
evaluate our options for advancing ridinilazole into Phase 3
clinical trials.”
HIGHLIGHTS
Utrophin Modulation Programme for DMD
Ezutromid Highlights
- Commenced patient enrolment in PhaseOut DMD, a Phase 2 clinical
trial of ezutromid; 24-week biopsy data from initial group of
patients expected in Q2/Q3 2017
- Reported positive data from Phase 1 clinical trial showing new
F6 formulation of ezutromid achieved over a six-fold increase in
maximum plasma levels in patients with a reduced oral dose compared
to current F3 formulation; data support incorporation of new F6
formulation into PhaseOut DMD trial to further explore potential
therapeutic effect of ezutromid, subject to regulatory
approval
- Outlined route to market strategy that includes placebo
controlled trial designed with potential to support accelerated and
conditional regulatory approvals in the US and EU respectively
Utrophin R&D Day
- Hosted event featuring three key opinion leaders in DMD in New
York City
CDI Programme
Ridinilazole Highlights
- Reported further data from Phase 2 CoDIFy clinical trial
showing ridinilazole outperformed the standard of care antibiotic
vancomycin in preserving microbiome during treatment of C.
difficile infection; microbiome sparing action of ridinilazole
associated with superiority over vancomycin in sustained clinical
response rate in CoDIFy
Financial Highlights
- Cash and cash equivalents at 31 July 2016 of £7.0 million
compared to £16.3 million at 31 January 2016
- Loss for the six months ended 31 July 2016 of £11.5 million
compared to a loss of £7.4 million for the six months ended 31 July
2015
Conference Call and Webcast
InformationSummit will host a conference call and webcast
to review the financial results for the second quarter ended 31
July 2016 today at 1:00pm BST / 8:00am EDT. To participate in the
conference call, please dial +44(0)20 3427 1911 (UK and
international participants) or +1 646 254 3367 (US local number)
and use the conference confirmation code 9792163. Investors may
also access a live audio webcast of the call via the investors
section of the Company’s website www.summitplc.com. A replay of the
webcast will be available shortly after the presentation
finishes.
About Summit TherapeuticsSummit
is a biopharmaceutical company focused on the discovery,
development and commercialization of novel medicines for
indications for which there are no existing or only inadequate
therapies. Summit is conducting clinical programs focused on the
genetic disease Duchenne muscular dystrophy and the infectious
disease C. difficile infection. Further information is available at
www.summitplc.com and Summit can be followed on Twitter
(@summitplc).
For more information, please
contact:
Summit
Therapeutics |
|
Glyn Edwards
/ Richard Pye (UK office) |
Tel: +44 (0)1235 443
951 |
Erik Ostrowski /
Michelle Avery (US office) |
+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) |
Tel: +1 781 235
3060 |
Chris Erdman / Karen
Sharma |
cerdman@macbiocom.com |
|
ksharma@macbiocom.com |
|
|
Consilium
Strategic Communications |
|
(Financial public
relations, UK) |
Tel: +44 (0)20 3709
5700 |
Mary-Jane Elliott / Sue
Stuart / |
summit@consilium-comms.com |
Jessica Hodgson /
Lindsey Neville |
|
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 develop a treatment for 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 orally administered
small molecule utrophin modulator product candidates. Summit’s most
advanced utrophin modulator is ezutromid which is currently being
evaluated in a Phase 2 proof of concept trial. 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. Ridinilazole markedly reduced recurrence rates and had a
statistically superior rate of sustained clinical response (‘SCR’)
compared to vancomycin in a Phase 2 proof of concept trial. Summit
is currently evaluating its options for advancing ridinilazole into
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
TrialPhaseOut DMD is a Phase 2 proof of concept clinical trial
evaluating ezutromid in patients with DMD. The 48-week open-label
trial 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 and North Star
Ambulatory Assessment, and patient reported outcomes, are also
being explored.
Enrolment and dosing of patients into PhaseOut
DMD at sites in the United Kingdom is now underway, with patients
expected to be enrolled into sites in the United States shortly.
The Company anticipates reporting data periodically during this
trial with 24-week muscle biopsy data from the first group of
patients expected to be reported in Q2/Q3 2017.
Ezutromid: Phase 1 New Formulation TrialSummit
announced in August 2016 the top-line data from a Phase 1 clinical
trial testing a new formulation of ezutromid, referred to as F6, in
patients with DMD. The trial evaluated the pharmacokinetics and
safety of three fixed doses (250mg, 500mg and 1,000mg twice a day)
of the F6 formulation in patients aged between five and nine years
who followed a modified diet. At the highest dose, the five
evaluable patients achieved an average maximum concentration of
390ng/mL on day 7, the final day of dosing. This represented a
greater than six-fold increase in maximum plasma levels but with a
reduced oral dose compared to the current clinical formulation of
ezutromid referred to as F3. In an earlier Phase 1 trial of the F3
formulation in patients who followed the same modified diet, an
average maximum plasma concentration of 63ng/mL (2,500mg, twice a
day) on the final day of dosing (day 14) was achieved.
Subject to regulatory approval, Summit now plans
to incorporate the F6 formulation into the ongoing PhaseOut DMD
proof of concept trial. Summit anticipates testing up to ten of the
40 patients expected to be enrolled on F6 to compare the safety and
efficacy of both formulations of ezutromid. This will help to
determine which formulation to use in future clinical trials. These
two formulations of ezutromid are expected to modulate utrophin and
with a wider range in blood plasma exposure, are expected to allow
Summit to further explore the potential therapeutic effect of
ezutromid in patients with DMD.
Ezutromid: Commercialisation StrategyInformed by
the clinical findings from the Phase 1 trial evaluating the F6
formulation of ezutromid, Summit outlined in August 2016 its
strategy for the future development of ezutromid. The Company plans
to conduct a randomised, placebo controlled trial designed with the
potential to support accelerated and conditional regulatory
approvals in the United States and Europe respectively. It is
anticipated that this trial would start in the second half of 2017
(assuming positive interim data from PhaseOut DMD), with data
available for potential regulatory filings in 2019. A separate
confirmatory clinical trial designed to support full product
approvals in major territories is also expected to be
conducted.
Summit holds exclusive, worldwide
commercialisation rights for ezutromid and its pipeline of utrophin
modulators. The Company’s existing strategy is to market ezutromid
on its own in the United States and Europe should ezutromid receive
marketing approval. The Company may however opportunistically
evaluate alternative marketing approaches including potential
collaboration, distribution and other marketing arrangements with
third parties.
Utrophin Modulator Pipeline UpdateAs part of the
Company’s strategy to maintain its leadership position in the field
of utrophin modulation, Summit has 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.
The substantial increase in ezutromid plasma levels achieved with
the F6 formulation in the recently completed Phase 1 trial
fulfilled the key objective for the second generation utrophin
modulator programme. In light of this progress, Summit has put the
development of the second generation on hold and will switch focus
to its pipeline of future generation utrophin modulators. This
research is aiming to build on the promise of ezutromid to identify
new, structurally distinct molecules, including ones that may have
possible new utrophin related mechanisms. This research is being
conducted as part of the strategic alliance with the University of
Oxford.
Utrophin R&D DaySummit hosted a Utrophin
R&D Day on 15 June 2016 in New York City. The event was
attended by analysts, institutional investors and members of the
DMD community and featured presentations from three key opinion
leaders in DMD alongside management. A replay of the event is
available on the Company website:
www.summitplc.com/investors/presentations.
C. difficile Infection
Programme
Phase 2 CoDIFy Clinical Trial: Presentation of
Additional Microbiome DataIn April 2016 at ECCMID and June 2016 at
ASM Microbe, additional data were reported from CoDIFy, the Phase 2
proof of concept clinical trial of ridinilazole. CoDIFy was a
double-blind, randomised active-control trial evaluating the
efficacy of ridinilazole against the current standard of care, the
antibiotic vancomycin. The trial 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.
In CoDIFy, ridinilazole demonstrated substantial
clinical benefit over vancomycin, including a large numerical
reduction in rates of recurrent disease. Recurrence of CDI, and the
failure to subsequently achieve a sustained clinical response after
treatment, is a major issue in the management of the disease, as
collateral damage to the gut microbiome by antibiotics such as
vancomycin leaves patients vulnerable to disease
recurrence.
The additional CoDIFy data from June also showed
ridinilazole outperformed vancomycin in the preservation of the gut
microbiome of patients. Stool samples from patients were analysed
for five specific bacterial groups associated with a healthy gut
microbiome (Bacteriodes, Prevotella, Enterbactericeae, C. coccoides
and C. leptum) and total bacteria present. Treatment with
vancomycin resulted in a significant decrease (p<0.001) in four
of the five bacterial groups and also resulted in a significant
decrease in total bacteria. In contrast, patients treated with
ridinilazole did not experience a decrease in these specific
bacterial groups, nor in total bacteria. In summary, these results
show ridinilazole may have advantages compared to vancomycin in
preserving a healthy gut microbiome during treatment for
CDI.
Summit believes these comprehensive data from
CoDIFy support the positioning of ridinilazole as a selective
antibiotic with potential to eradicate the C. difficile bacteria
while simultaneously preserving the microbiome to protect against
disease recurrence.
Separately, an exploratory Phase 2 clinical
trial evaluating ridinilazole against the antibiotic fidaxomicin is
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.
The development of ridinilazole has been
financially supported by Seeding Drug Discovery and Translational
Awards from the Wellcome Trust.
The Company continues to explore options to
support the future development of ridinilazole through Phase 3
trials as it seeks to maximise the potential commercial value of
this antibiotic. Summit’s preference remains finding a third party
collaborator although the Company continues to evaluate other
potential options including funding from government and non-profit
organisations.
FINANCIAL REVIEW
Other Operating Income
Other operating income for the three months
ended 31 July 2016 was £0.02 million compared to £0.4 million for
the three months ended 31 July 2015. Other operating income for the
six months ended 31 July 2016 was £0.08 million compared to £0.8
million for the six months ended 31 July 2015. Income recognised as
part of the Wellcome Trust Translational Award was lower in both
the three months ended 31 July 2016 and the six months ended 31
July 2016 as a result of a lower contribution rate ascribed to
Phase 2 clinical trial activities compared to Phase 1 activities
under the terms of the funding agreement. As of 31 July 2016, all
monies and income receivable from the Wellcome Trust have now been
received and accounted for with the completion of our CoDIFy Phase
2 clinical trial of ridinilazole. Income recognised as part of the
funding from Innovate UK for the DMD programme was also lower in
both the three months ended 31 July 2016 and the six months ended
31 July 2016. The decrease in income is in line with the
achievement of milestones to date under the funding agreement. In
September 2016, the Company elected to withdraw from the Innovate
UK funding agreement in order to enable the Company to take
advantage of more tax efficient opportunities related to research
and development expenditure.
Operating Expenses
Research and Development ExpensesResearch and development
expenses increased by £1.2 million to £5.4 million for the three
months ended 31 July 2016 from £4.2 million for the three months
ended 31 July 2015. Research and development expenses increased by
£2.8 million to £10.2 million for the six months ended 31 July 2016
from £7.4 million for the six months ended 31 July 2015. These
increases reflected the increased investment in the DMD programme
and an increase in research and development related staffing costs
driven by an increase in research and development related
headcount.
General and Administration ExpensesGeneral and
administration expenses increased by £0.9 million to £1.9 million
for the three months ended 31 July 2016 from £1.0 million for the
three months ended 31 July 2015. General and administration
expenses increased by £1.2 million to £3.3 million for the six
months ended 31 July 2016 from £2.1 million for the six months
ended 31 July 2015. These increases were primarily due to
continuing additional corporate costs associated with being a
publicly traded company in the United States as well as in the
United Kingdom and an increase in staff related costs offset by a
favourable exchange rate variance for both the three months ended
31 July 2016 and the six months ended 31 July 2016.
Cash Flows
Operating ActivitiesNet cash used by operating
activities increased by £2.4 million to £9.4 million for the six
months ended 31 July 2016 compared to £7.0 million for the six
months ended 31 July 2015. This increase is due to an increase in
research and development expenditure and general and administrative
expenditure offset by a £1.6 million increase in the amount of
research and development tax credit received during the six months
ended 31 July 2016 which totalled £3.0 million.
Investing ActivitiesNet cash used in investing
activities for the six months ended 31 July 2016 and the six months
ended 31 July 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 six months ended 31 July 2016 relates
to proceeds of £0.1 million received following the exercise of
warrants on 14 April 2016 and the exercise of share options on 28
June 2016. For the six months ended 31 July 2015 the Company
received net proceeds of £22.0 million from the sale of equity
securities.
Financial position
As at 31 July 2016, total cash and cash
equivalents held were £7.0 million (31 January 2016: £16.3
million).
OUTLOOK
Strong progress has been made in the clinical
development of ezutromid. With two promising formulations of
ezutromid in clinical development, Summit is focused on the
efficient evaluation of the efficacy and safety of this utrophin
modulator which has orphan drug status in the US and Europe. The
Company’s plans are designed to support early submissions for
accelerated and conditional approvals while continuing to build a
broad and robust body of clinical evidence and working towards
obtaining regulatory approval of ezutromid and making it available
to all patients with DMD. Given the potential benefit of ezutromid
for all patients with DMD, the Company believes that it represents
a very compelling product candidate with the potential to generate
value for shareholders.
The Company further believes that the
comprehensive data from the CoDIFy clinical trial support the
positioning of ridinilazole as a selective antibiotic with the
potential to treat C. difficile infection, while simultaneously
preserving the microbiome to help protect against recurrent
disease. The additional data recently reported underline the
commercial opportunity for ridinilazole, and the Company’s
preference is to partner with a third-party collaborator on the
development and commercialisation of the product candidate.
FINANCIAL STATEMENTS
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
(unaudited) For the three months ended 31 July 2016
|
|
Three months ended 31 July 2016 |
Three months ended 31 July 2016 |
Three months ended 31 July 2015 |
|
Note |
$000s |
£000s |
£000s |
|
|
|
|
|
Other operating
income |
|
|
22 |
|
|
17 |
|
|
427 |
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
Research and development |
|
|
(7,163 |
) |
|
(5,398 |
) |
|
(4,224 |
) |
General and
administration |
|
|
(2,534 |
) |
|
(1,910 |
) |
|
(1,002 |
) |
Total operating
expenses |
|
|
(9,697 |
) |
|
(7,308 |
) |
|
(5,226 |
) |
|
|
|
|
|
Operating
loss |
|
|
(9,675 |
) |
|
(7,291 |
) |
|
(4,799 |
) |
|
|
|
|
|
Finance
income |
|
|
3 |
|
|
2 |
|
|
9 |
|
|
|
|
|
|
Loss before
income tax |
|
|
(9,672 |
) |
|
(7,289 |
) |
|
(4,790 |
) |
|
|
|
|
|
Income
tax |
|
|
1,428 |
|
|
1,076 |
|
|
757 |
|
|
|
|
|
|
Loss for the
period |
|
|
(8,244 |
) |
|
(6,213 |
) |
|
(4,033 |
) |
|
|
|
|
|
Other
comprehensive income / (losses) |
|
|
|
|
Exchange differences on translating foreign operations |
|
|
28 |
|
|
21 |
|
|
(12 |
) |
Total comprehensive loss for the period |
|
|
(8,216 |
) |
|
(6,192 |
) |
|
(4,045 |
) |
Basic and diluted loss per Ordinary Share from
operations |
2 |
(13)cents |
(10)pence |
(7)pence |
FINANCIAL STATEMENTS
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
(unaudited) For the six months ended 31 July 2016
|
|
Six months ended 31 July 2016 |
Six months ended 31 July 2016 |
Six months ended 31 July 2015 |
|
Note |
$000s |
£000s |
£000s |
|
|
|
|
|
Other operating
income |
|
|
100 |
|
|
76 |
|
|
835 |
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
Research and development |
|
|
(13,541 |
) |
|
(10,204 |
) |
|
(7,357 |
) |
General and
administration |
|
|
(4,434 |
) |
|
(3,342 |
) |
|
(2,077 |
) |
Total operating
expenses |
|
|
(17,975 |
) |
|
(13,546 |
) |
|
(9,434 |
) |
|
|
|
|
|
Operating
loss |
|
|
(17,875 |
) |
|
(13,470 |
) |
|
(8,599 |
) |
|
|
|
|
|
Finance
income |
|
|
7 |
|
|
5 |
|
|
16 |
|
|
|
|
|
|
Loss before
income tax |
|
|
(17,868 |
) |
|
(13,465 |
) |
|
(8,583 |
) |
|
|
|
|
|
Income
tax |
|
|
2,669 |
|
|
2,011 |
|
|
1,184 |
|
|
|
|
|
|
Loss for the
period |
|
|
(15,199 |
) |
|
(11,454 |
) |
|
(7,399 |
) |
|
|
|
|
|
Other
comprehensive income |
|
|
|
|
Exchange differences on translating foreign operations |
|
|
21 |
|
|
16 |
|
|
3 |
|
Total comprehensive loss for the period |
|
|
(15,178 |
) |
|
(11,438 |
) |
|
(7,396 |
) |
Basic and diluted loss per Ordinary Share from
operations |
2 |
(25)cents |
(19)pence |
(13)pence |
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
(unaudited)As at 31 July 2016
|
|
31 July2016 |
31
July 2016 |
31 January 2016 |
|
|
$000s |
£000s |
£000s |
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
Goodwill |
|
|
881 |
|
|
664 |
|
|
664 |
|
Intangible assets |
|
|
4,612 |
|
|
3,476 |
|
|
3,473 |
|
Property,
plant and equipment |
|
|
117 |
|
|
88 |
|
|
83 |
|
|
|
|
5,610 |
|
|
4,228 |
|
|
4,220 |
|
Current
assets |
|
|
|
|
Prepayments and other
receivables |
|
|
1,837 |
|
|
1,384 |
|
|
1,538 |
|
Current tax
receivable |
|
|
2,683 |
|
|
2,022 |
|
|
3,014 |
|
Cash and
cash equivalents |
|
|
9,283 |
|
|
6,996 |
|
|
16,304 |
|
|
|
|
13,803 |
|
|
10,402 |
|
|
20,856 |
|
|
|
|
|
|
Total assets |
|
|
19,413 |
|
|
14,630 |
|
|
25,076 |
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
Non-current
liabilities |
|
|
|
|
Provisions for other
liabilities and charges |
|
|
(113 |
) |
|
(85 |
) |
|
(73 |
) |
Deferred tax
liability |
|
|
(881 |
) |
|
(664 |
) |
|
(664 |
) |
|
|
|
(994 |
) |
|
(749 |
) |
|
(737 |
) |
Current liabilities |
|
|
|
|
Trade and other
payables |
|
|
(4,395 |
) |
|
(3,312 |
) |
|
(3,206 |
) |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
(5,389 |
) |
|
(4,061 |
) |
|
(3,943 |
) |
|
|
|
|
|
Net assets |
|
|
14,024 |
|
|
10,569 |
|
|
21,133 |
|
|
|
|
|
|
EQUITY |
|
|
|
|
Share capital |
|
|
816 |
|
|
615 |
|
|
613 |
|
Share premium
account |
|
|
61,231 |
|
|
46,143 |
|
|
46,035 |
|
Share-based payment
reserve |
|
|
5,999 |
|
|
4,521 |
|
|
3,757 |
|
Merger reserve |
|
|
(2,578 |
) |
|
(1,943 |
) |
|
(1,943 |
) |
Special reserve |
|
|
26,531 |
|
|
19,993 |
|
|
19,993 |
|
Currency translation
reserve |
|
|
49 |
|
|
37 |
|
|
21 |
|
Accumulated losses reserve |
|
|
(78,024 |
) |
|
(58,797 |
) |
|
(47,343 |
) |
Total equity |
|
|
14,024 |
|
|
10,569 |
|
|
21,133 |
|
CONSOLIDATED STATEMENT OF CASH FLOWS
(unaudited) For the six months ended 31 July 2016
|
|
Six months ended 31 July
2016 |
Six months ended 31 July
2016 |
Six months ended31 July 2015 |
|
|
$000s |
£000s |
£000s |
Cash flows from
operating activities |
|
|
|
|
Loss before income
tax |
|
|
(17,868 |
) |
|
(13,465 |
) |
|
(8,583 |
) |
|
|
|
(17,868 |
) |
|
(13,465 |
) |
|
(8,583 |
) |
|
|
|
|
|
Adjusted for: |
|
|
|
|
Finance income |
|
|
(7 |
) |
|
(5 |
) |
|
(16 |
) |
Foreign exchange
gain |
|
|
(80 |
) |
|
(60 |
) |
|
(9 |
) |
Depreciation |
|
|
31 |
|
|
23 |
|
|
17 |
|
Amortisation of
intangible fixed assets |
|
|
7 |
|
|
5 |
|
|
5 |
|
Increase in
provisions |
|
|
16 |
|
|
12 |
|
|
14 |
|
Research and
development expenditure credit |
|
|
(4 |
) |
|
(3 |
) |
|
(21 |
) |
Share-based payment |
|
|
1,014 |
|
|
764 |
|
|
510 |
|
Adjusted loss from
operations before changes in working capital |
|
|
(16,891 |
) |
|
(12,729 |
) |
|
(8,083 |
) |
|
|
|
|
|
Decrease in prepayments
and other receivables |
|
|
204 |
|
|
154 |
|
|
781 |
|
Increase
/(decrease) in trade and other payables |
|
|
162 |
|
|
122 |
|
|
(1,057 |
) |
Cash used by
operations |
|
|
(16,525 |
) |
|
(12,453 |
) |
|
(8,359 |
) |
Taxation
received |
|
|
3,988 |
|
|
3,005 |
|
|
1,401 |
|
Net cash used in operating activities |
|
|
(12,537 |
) |
|
(9,448 |
) |
|
(6,958 |
) |
|
|
|
|
|
|
|
|
|
|
Investing
activities |
|
|
|
|
Purchase of property, plant and equipment |
|
|
(37 |
) |
|
(28 |
) |
|
(24 |
) |
Interest received |
|
|
7 |
|
|
5 |
|
|
16 |
|
Net cash used in investing activities |
|
|
(30 |
) |
|
(23 |
) |
|
(8 |
) |
|
|
|
|
|
Financing
activities |
|
|
|
|
Proceeds from issue of
share capital |
|
|
- |
|
|
- |
|
|
26,101 |
|
Transaction costs on
share capital issued |
|
|
- |
|
|
- |
|
|
(4,187 |
) |
Proceeds from exercise
of warrants |
|
|
142 |
|
|
107 |
|
|
- |
|
Exercise of share
options |
|
|
4 |
|
|
3 |
|
|
222 |
|
Net cash generated from financing activities |
|
|
146 |
|
|
110 |
|
|
22,136 |
|
|
|
|
|
|
(Decrease) /
increase in cash and cash equivalents |
|
|
(12,421 |
) |
|
(9,361 |
) |
|
15,170 |
|
|
|
|
|
|
Effect of
exchange rates in cash and cash equivalents |
|
|
69 |
|
|
53 |
|
|
- |
|
|
|
|
|
|
Cash and cash
equivalents at beginning of the period |
|
|
21,635 |
|
|
16,304 |
|
|
11,265 |
|
|
|
|
|
|
Cash and cash equivalents at end of the
period |
|
|
9,283 |
|
|
6,996 |
|
|
26,435 |
|
CONSOLIDATED STATEMENT OF CHANGES IN
EQUITY (unaudited)
Six months ended 31 July 2016
Group |
|
Share capital £000s |
Share premium account£000s |
Share-based payment reserve£000s |
Merger reserve£000s |
Special reserve £000s |
Currencytranslationreserve£000s |
Accumulated losses reserve£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 |
|
- |
- |
- |
|
- |
|
- |
- |
|
(11,454 |
) |
|
(11,454 |
) |
Currency translation
adjustment |
|
- |
- |
- |
|
- |
|
- |
16 |
|
- |
|
|
16 |
|
Total comprehensive loss for the period |
|
- |
- |
- |
|
- |
|
- |
16 |
|
(11,454 |
) |
|
(11,438 |
) |
New share capital issued from exercise of
warrants |
|
2 |
105 |
- |
|
- |
|
- |
- |
|
- |
|
|
107 |
|
Share options exercised |
|
- |
3 |
- |
|
- |
|
- |
- |
|
- |
|
|
3 |
|
Share-based payment |
|
- |
- |
764 |
|
- |
|
- |
- |
|
- |
|
|
764 |
|
At 31 July 2016 |
|
615 |
46,143 |
4,521 |
|
(1,943 |
) |
19,993 |
37 |
|
(58,797 |
) |
|
10,569 |
|
Year ended 31 January 2016
Group |
|
Share capital £000s |
Share premium account£000s |
Share-based payment reserve£000s |
Merger reserve£000s |
Special reserve£000s |
Currencytranslationreserve£000s |
Accumulated losses reserve£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 |
|
- |
|
- |
|
- |
|
- |
|
- |
|
- |
|
|
(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 |
|
Six months ended 31 July 2015
Group |
|
Share capital £000s |
Share premium account£000s |
Share-based payment reserve£000s |
Merger reserve£000s |
Special reserve £000s |
Currencytranslationreserve£000s |
Accumulated losses reserve£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 |
|
- |
|
- |
|
- |
|
- |
|
- |
- |
|
(7,399 |
) |
|
(7,399 |
) |
Currency translation
adjustment |
|
- |
|
- |
|
- |
|
- |
|
- |
3 |
|
- |
|
|
3 |
|
Total comprehensive loss for the period |
|
- |
|
- |
|
- |
|
- |
|
- |
3 |
|
(7,399 |
) |
|
(7,396 |
) |
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 |
|
- |
|
- |
|
510 |
|
- |
|
- |
- |
|
- |
|
|
510 |
|
At 31 July 2015 |
|
613 |
|
46,035 |
|
3,107 |
|
(1,943 |
) |
19,993 |
65 |
|
(37,654 |
) |
|
30,216 |
|
NOTES TO THE FINANCIAL STATEMENTSFor the six
months ended 31 July 2016
1. Basis of accounting
The unaudited consolidated interim financial
statements of Summit and its subsidiaries (the ‘Group’) for the six
months ended 31 July 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, have been delivered to the
Registrar 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.
The Group has incurred significant losses and negative cash
flows from operations since inception, has an accumulated deficit,
and has limited cash resources. 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, following which the Group needs to raise
additional capital to fund its future operations. The Group
is evaluating various options to finance its cash needs, including
any or a combination of equity offerings, collaborations, and debt
financings. Whilst we believe that funds would be available
in this manner before the end of December, 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 and six
month periods ended 31 July 2016 and 2015 are unaudited.
Solely for the convenience of the reader, unless
otherwise indicated, all pound sterling amounts stated in the
Consolidated Balance Sheet as at 31 July 2016, in the Consolidated
Income Statement for the three and six months ended 31 July 2016
and in the Consolidated Cash Flow Statement for the six months
ended 31 July 2016 have been translated into US dollars at the rate
on 29 July 2016 of $1.3270 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 8 September 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 six month period to 31 July 2016:
61,399,419 and during the three month period to 31 July 2016:
61,473,829 (for the six month period to 31 July 2015: 56,853,054,
for the three month period to 31 July 2015: 61,122,601).
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.
On 28 June 2016, the number of ordinary shares
increased to 61,484,452 following the share option exercise of
16,667 ordinary shares at an exercise price of 20 pence per share.
The issue of shares raised net proceeds of £3,333.
All new ordinary shares rank pari passu with
existing ordinary shares.
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