Verona Pharma
plc
("Verona Pharma" or the
"Company")
Interim results
for the six months ended 30 June
2016
Significant
clinical progress and strong balance sheet bodes well for future of
RPL554
13 September 2016, Cardiff – Verona Pharma plc (AIM: VRP.L),
the drug development company focused on first-in-class medicines to
treat respiratory diseases, today announces its interim results for
the six months ended 30 June
2016.
OPERATIONAL HIGHLIGHTS
· Reported positive results from
“add-on” Phase 2 study with RPL554 in COPD patients. Data continues
to suggest drug could be a meaningful new addition, alone or in
combination, for the treatment of COPD
o Primary objective of study met; RPL554 produced a highly
significant (P<0.001) and a clinically meaningful additional
(>50%) bronchodilation on top of the administered standard of
care bronchodilators, salbutamol or ipratropium bromide
o The bronchodilator effects seen with the combinations
were significantly (P<0.001) larger than those of either
salbutamol or ipratropium bromide alone, which were in turn all
significantly greater than placebo
o Secondary objectives also met; the combination of RPL554
with salbutamol or ipratropium bromide caused a significant
reduction (p=0.0002 and p=0.004 respectively) in trapped air in the
lung (residual volume) as compared to salbutamol or ipratropium
bromide alone, suggesting that RPL554 treatment may reduce dyspnea,
a major debilitating symptom of COPD1
o Consistent with previous studies, RPL554 was well
tolerated both alone and in combination
- No effect on vital signs or ECG parameters
- No gastro-intestinal adverse events recorded
· Reported positive results from
dose finding study with RPL554 in asthmatic patients
o Primary objective of study met; nebulized RPL554
demonstrated a dose-dependent bronchodilator response in asthma
patients; the response was highly statistically significant
(p<0.0001) at all doses tested
o The maximum bronchodilator effect of RPL554 in this
study was comparable to the effect observed with the supramaximal
dose (7.5mg) of nebulized salbutamol used in the study
o Large dose range (0.4 to 24mg) examined; suggests RPL554
potentially has a large safety margin
o RPL554 did not elicit any serious adverse events or
adverse events of concern at any dose
- Fewer adverse events recorded with RPL554 than with nebulized
salbutamol
- No gastro-intestinal adverse events or cardiovascular events
of concern
· Data from first Phase 1 study
with RPL554 supporting the Company’s view that RPL554 could become
an important, novel and complementary inhaled medicine for the
treatment of respiratory diseases such as COPD, asthma and cystic
fibrosis presented at American Thoracic Society (ATS) 2016
International Conference in USA:
o Studies continue to demonstrate the excellent
bronchodilator properties of RPL554
o Formulation is much better tolerated than the earlier
solution formulation prototype, with no maximum tolerated dose
observed even at 16 times the active bronchodilator dose
o New formulation is suitable for twice daily dosing
o Formulation provides for a longer pulmonary residence
time, lower peak plasma exposure and longer half-life in blood than
the earlier formulation suggesting a more pronounced effect locally
in the lung and comparatively less effects in other organs in the
body
FINANCIAL HIGHLIGHTS
· Loss after tax for the period of
£1.60 million (2015: £3.69 million) or 0.16
pence (2015: 0.37 pence) per
ordinary share, reflecting a tight control over costs.
· Net cash outflows from operating
activities during the six month period of £2.23 million (2015:
£3.92 million), with cash and cash equivalents as at 30 June 2016
of £1.21million (2015: £6.09 million) with spending focused on
RPL554 clinical trials and related activities.
POST PERIOD AND OTHER EVENTS
· Fundraising completed in July
2016 to raise gross proceeds of £44.7 million (approximately
US$63.3 million at the exchange rate
of 17 June 2016) by way of a placing to issue 1,555,796,345 placing
shares at a price of 2.873 pence per
share (each placing share includes one warrant to subscribe for 0.4
of a placing share)
o The net proceeds of the Placing of £41.9 million will
predominantly be used to progress RPL554 through a Phase 2b
clinical trial in COPD patients, and to fund additional clinical
Phase 2 studies in COPD and cystic fibrosis as well as further
supportive pre-clinical work
o The cornerstone investors in the Placing are specialist
healthcare focused funds Vivo Capital, OrbiMed and Edmond de
Rothschild Investment Partners
o Other new investors include New Enterprise Associates,
Novo A/S, Abingworth and Aisling Capital with participation of
existing investors including Arix Bioscience, Hargreave Hale and
Polar Capital
· On 29 July 2016, three
additional Non-Executive Directors joined the Verona Pharma Board
as representatives of certain of the investors in the Placing:
Mahendra Shah (Vivo Capital),
Rishi Gupta (Orbimed) and
Andrew Sinclair (Abingworth)
· On 12 September 2016,
Vikas Sinha joined the Verona Pharma
Board as an independent Non-Executive Director
· Clinical data from Phase 2a “add
on” study with RPL554 presented at the European Respiratory Society
(ERS) 2016 International Conference in London
Dr. Jan-Anders Karlsson, CEO of
Verona Pharma commented: “We have continued to make excellent
progress with the clinical development of RPL554. The headline data
reported from the two clinical trials during the period continues
to support our belief that this first-in-class drug could be a
meaningful new treatment for COPD patients.
“The recent fund raise is a
significant milestone in the Company’s history which allows us to
continue development in later stage Phase 2 trials. The fundraising
has also brought a number of specialist healthcare investors as new
shareholders. Several of them have now joined our Board and we look
forward to benefiting from their multi-faceted experience in the
sector.”
This announcement contains inside information.
-ENDS-
About Verona Pharma
Verona Pharma plc is a UK-based clinical stage biotech company
focused on the development of innovative prescription medicines to
treat respiratory diseases with significant unmet medical needs,
such as chronic obstructive pulmonary disease (COPD), asthma and
cystic fibrosis.
Verona Pharma's lead drug, RPL554, is a first-in-class drug
currently in Phase 2 trials as a nebulized maintenance treatment
for COPD patients with moderate to severe disease and possibly as a
treatment of acute exacerbations of COPD in the hospital setting.
The drug is a dual phosphodiesterase (PDE) 3/4 inhibitor and
therefore has both bronchodilator and anti-inflammatory effects,
which are essential to the improvement of patients with COPD and
asthma.
Verona Pharma is also building a broader portfolio of
RPL554-containing products to maximize its benefit to patients and
its value. This includes the very significant markets for COPD and
asthma maintenance therapy. The Company is also exploring the
potential of the drug in different diseases, such as cystic
fibrosis, where it is in pre-clinical testing and has received a
Venture and Innovation Award from the Cystic Fibrosis Trust.
For further information, please
contact:
Verona Pharma plc |
Tel: +44 (0)20 3283 4200 |
Jan-Anders Karlsson, CEO |
|
N+1 Singer |
Tel: +44 (0)20 7496 3000 |
Aubrey Powell / Jen
Boorer |
|
FTI Consulting |
Tel: +44 (0)20 3727 1000 |
Simon Conway /
Stephanie Cuthbert /
Natalie Garland-Collins |
|
CHAIRMAN AND CHIEF EXECUTIVE OFFICER’S
JOINT STATEMENT
INTRODUCTION
Verona Pharma is a UK-based clinical
stage biotech company focused on the development of innovative
prescription medicines to treat respiratory diseases with
significant unmet medical needs such as chronic obstructive
pulmonary disease (COPD) and cystic fibrosis. The Company’s lead
product, RPL554, is a first-in-class, inhaled dual
phosphodiesterase PDE3/PDE4 inhibitor that is ready to start Phase
2b as a nebulized formulation for treatment of patients with COPD.
The drug has already demonstrated clinically relevant
bronchodilator and anti-inflammatory effects which are essential to
the improvement of symptoms in patients with COPD.
The Board believes that broadening the development strategy for
RPL554, to include new indications and combination products,
together with strengthening the IP coverage around the program, has
the potential to add significant value to the Company. To enable
this larger development program and to broaden the investor base,
to include healthcare focused funds based in the US as well as in
the UK and Europe, the Company
raised gross proceeds of £44.7 million via a placing post period
(the Placing). The cornerstone investors in the Placing were the
specialist healthcare focused funds Vivo Capital, OrbiMed and
Edmond de Rothschild Investment Partners, with other new investors
including New Enterprise Associates, Novo A/S, Abingworth and
Aisling Capital and participation of the existing investors Arix
Bioscience, Hargreave Hale and Polar Capital.
The net proceeds of the Placing of approximately £41.9 million
will be used predominantly to progress the Company’s lead product,
RPL554, through a Phase 2b clinical trial in COPD patients, to fund
additional clinical Phase 2 studies in COPD and cystic fibrosis,
and to fund further supportive pre-clinical work, including the
development of a dry powder inhaler (DPI) or metered dose inhaler
(MDI). The Board believes that this funding provides a strong
platform to accelerate the development of RPL554 for subsequent
commercial use in multi-billion dollar markets and creates greater
strategic flexibility to maximize future value for Shareholders.
The Board further believes that the Company’s strong balance sheet
increases both Verona Pharma’s flexibility in negotiating
attractive commercial collaborations and its ability to expand
patent protection for the emerging franchise.
Industry Background
The Company is initially developing RPL554 as a treatment for
patients with COPD. These patients are commonly treated with
bronchodilators to dilate the airways and thereby ease breathing
and reduce breathlessness, a major symptom in these patients, and
with glucocorticosteroids to reduce the chronic inflammation of the
airways. For more severe patients that are not well controlled, an
oral formulation of an anti-inflammatory PDE4 inhibitor is added.
Despite the recently introduced novel maintenance treatments for
COPD, many patients experience acute worsening with cough, sputum
production and breathlessness, and become hospitalized. For many of
these patients, a better and more effective maintenance treatment
is required, that can control their symptoms and reduce the risk of
exacerbations. For those patients that end up in hospital, older,
short-acting nebulized bronchodilators are still used on hospital
wards and there is clearly a need for effective treatments in this
acute hospital setting. We believe RPL554 can become an attractive
add-on therapy to provide extra clinical benefit in patients with
acute exacerbations of COPD. There is little innovation in the form
of novel classes of bronchodilator or anti-inflammatory drugs for
these acutely ill patients, or for the maintenance treatment of
COPD patients, and the Board therefore believes that these are very
attractive commercial opportunities for Verona Pharma.
An increasing awareness of the problem of COPD patients
returning for hospital treatment within 30 days of discharge has
triggered a strong interest from industry, regulators and
healthcare administrators and payers in optimizing treatment of
acute COPD exacerbations and beyond, when patients are discharged
from hospital. This provides an opportunity for RPL554 that we
intend to explore in further Phase 2 clinical studies.
Almost 10% of COPD patients, most likely the more severely ill
patients, prefer treatment with a nebulizer instead of using an MDI
or DPI. Normal breathing through a mouthpiece or facemask is
convenient and comforting when the patient is anxious about
receiving the treatment. A nebulizer is both convenient and
effective in delivering a large and effective dose. About 9% of
COPD patients in the US prefer treatment with a nebulizer over a
hand-held device MDI/DPI, while up to 30% of these patients use a
nebulizer more intermittently. We are initially developing RPL554
as a nebulized treatment for more severe patients, at home or after
they have been admitted to hospital. Importantly, the development
and regulatory paths of a nebulized treatment is different from
that of an MDI or DPI. Based on initial experiments, we have
demonstrated that RPL554 can be used in a range of both jet and
mesh nebulizers.
Positive data with RPL554 in Phase 2a
clinical studies in 2015
As a nebulized treatment, RPL554 successfully completed a number
of early clinical Phase 1 and Phase 2 studies. These single and
multiple dose studies demonstrate that RPL554, when inhaled across
a range of doses, is an effective bronchodilator in patients with
COPD and asthma. RPL554 has a rapid onset of action and the
magnitude of the bronchodilator effect seems to be at least as
profound as that of other commonly used bronchodilator
drugs.2
RPL554 has also been demonstrated to have a potent
anti-inflammatory effect in a clinical trial. This property is
unique to RPL554 and is not shown by other bronchodilator drugs of
the beta2 agonists or anti-muscarinic classes. RPL554 showed a
broad inhibitory effect on inflammatory cells in the airways,
including a significant reduction in the number of neutrophils, a
cell type thought to be involved in COPD (and cystic fibrosis).
This effect sets RPL554 apart from steroids as this class of drugs
seem to have little effect on neutrophils and increasingly the use
of inhaled steroids in COPD patients is being questioned as they
seem to have limited beneficial effects. Therefore, RPL554 as a
combined bronchodilator and anti-inflammatory agent offers unique
benefits to COPD patients, both as a novel type of bronchodilator,
and as an anti-inflammatory compound offering additional benefits
over and above those of steroids.
As the original proof of concept formulation could not be
commercialized, a novel nebulized proprietary suspension
formulation of RPL554 was developed which is stable, scalable and
suitable for commercial use. The first Phase 1/2a study with the
new nebulized formulation was a Single Ascending Dose (SAD) and
Multiple Ascending Dose (MAD, 5 days, twice daily dosing) study in
80 healthy subjects and a 5 day MAD study in 32 COPD patients
completed in 2015. The new formulation was well tolerated as 16
times the previously used bronchodilator dose (with the old
formulation) could be administered without reaching a maximum
tolerated dose. Pharmacokinetic analysis revealed a significantly
longer pulmonary residence time, a substantially lower peak plasma
concentration and a longer plasma half-life than the previously
used formulation, suggesting longer exposure of the target organ
(lung) to RPL554, less systemic activity and that twice daily
dosing most likely could be achieved. The study also demonstrated
the excellent bronchodilator properties of RPL554 indicating that
it is able to produce large improvements in lung function in
healthy subjects as well as patients with mild, moderate or severe
lung disease.
Successful Phase 2a and add-on study
for RPL554 in interim period
A single-dose, 7-way cross over Phase 2a dose-finding study with
the new formulation was conducted in 29 asthma patients in 2016.
The study was performed in asthma patients because typically a dose
response relationship to bronchodilators can be more accurately
established in this group of patients with highly reversible
airways obstruction compared to patients with COPD. A wide range of
RPL554 doses were compared to two different doses of salbutamol, a
standard bronchodilator used in both asthma and COPD patients, and
placebo. The primary objective of the study was met as nebulized
RPL554 demonstrated a highly statistically significant and
dose-dependent bronchodilator response in asthma patients. The
maximum bronchodilator effect of RPL554 in this study was
comparable to the effect observed with the supramaximal dose of
nebulized salbutamol used in the study. RPL554 did not elicit any
serious adverse events or adverse events of concern at any dose,
suggesting that RPL554 potentially has a very large safety margin.
There were also fewer adverse events recorded with RPL554 than with
nebulized salbutamol and no gastro-intestinal adverse events or
cardiovascular events of concern.
In a second Phase 2a study in COPD patients, RPL554 produced a
highly significant (P<0.001) and a clinically meaningful
additional (>60%) bronchodilation when administered on top of
standard of care bronchodilators, salbutamol or ipratropium
bromide. The bronchodilator effects seen with the combinations were
significantly (P?0.001) larger than those of either salbutamol or
ipratropium bromide alone, which were in turn all significantly
greater than placebo. In addition, the combination of RPL554 with
salbutamol or ipratropium bromide caused a significant reduction
(p=0.0002 and p=0.004 respectively) of trapped air in the lung
(residual volume) as compared to salbutamol or ipratropium bromide
alone suggesting that RPL554 treatment may reduce dyspnea, a major
debilitating symptom of COPD. Consistent with previous studies,
RPL554 was well tolerated both alone and in combination. No effect
on vital signs or ECG parameters or gastro-intestinal adverse
events were recorded.
We have investigated RPL554 as a combination product with an
anti-muscarinic drug, such as glycopyrrolate, a class of drugs that
is widely used in treating COPD patients. We have been strongly
encouraged by data showing a synergistic effect of RPL554 in
combination with anti-muscarinic drugs in isolated human airway
smooth muscle. Such a combination product could have significant
advantages over the many dual long-acting agonists/long
acting-muscarinic antagonists (LABA/LAMA) bronchodilator inhalers
available to COPD patients and could be used both in acute hospital
care and in long-term maintenance treatment.
In addition to treatment of acute exacerbations, RPL554 clearly
has potential as a chronic maintenance therapy in patients with
COPD. Both the bronchodilator and the anti-inflammatory properties
would be beneficial to these out-patients and it is a larger market
opportunity. The new nebulized formulation could be developed into
an attractive maintenance treatment for those moderate to severe
COPD patients that prefer to use a nebulizer. There is an even
larger market for COPD patients that are routinely treated with a
DPI or pressurized metered dose inhaler (pMDI) and we have
previously demonstrated that RPL554 can be formulated for use in
both a DPI and a pMDI.
RPL554 shows promise as a treatment of
cystic fibrosis
Additional pre-clinical data continue to demonstrate the
potential usefulness of RPL554 as a treatment of cystic fibrosis.
RPL554 is an activator of the cystic fibrosis transmembrane
conductance regulator (CFTR) that is dysfunctional in cells of
cystic fibrosis patients (because of different types of gene
mutations). A direct effect on the CFTR, an anti-inflammatory
effect on many of the key inflammatory cells in the lungs of cystic
fibrosis patients and a direct bronchodilator effect may
collectively improve mucociliary clearance (reduce phlegm in the
airways), reduce symptoms of chronic inflammation and ease
breathing. This adds a further dimension to the potential utility
of the drug. Further studies exploring the potential of RPL554 in
cystic fibrosis are being planned.
FINANCIALS
The loss from operations after tax for the six month period
ended 30 June 2016 (the “Period”) was
£1.60 million (2015: £3.69 million) or 0.16
pence (2015: 0.37 pence) per
ordinary share. The reported loss includes a non-cash share-based
payment charge of £0.18 million (2015: £0.26 million) and a
research and development tax credit receivable of £0.28 million
(2015: £0.74 million).
Research and development expenditure, which was expensed as
incurred, amounted to £1.24 million (2015: £3.48 million).
Development program expenditures during the period amounted to
£1.24 million for RPL554 (2015: £3.37 million), and the 2015
results include £0.11 million for VRP700 as a result of the
discontinuance of the VRP700 program.
Expenditures in RPL554 reduced by £2.13 million as a result of
the clinical trials ceasing as the Company came to the end of Phase
2a.
Administrative expenses for the period were £0.66 million (2015:
£0.99 million). The reduction of £0.33 million over the prior
period was due to a decrease in share-based payment charge and
other administrative items.
As at 30 June 2016, the Group had
approximately £1.21 million (2015: £6.09 million) in cash and cash
equivalents.
FURTHER DEVELOPMENT &
COMMERCIALIZATION STRATEGY
The Company has made significant progress since the fundraising
in March 2014 which enabled us to
advance the new commercial formulation of RPL554 through clinical
studies up to the start of Phase 2b, which is expected in the
second half of 2016. Additional pre-clinical and manufacturing work
will be performed to satisfy certain regulatory guidelines. In
parallel, we are continuing to strengthen the IP coverage to
provide comprehensive patent protection for RPL554 in its various
forms, with the intention of expanding the use of RPL554 in new
indications and in combination products.
Our focus on developing the nebulized formulation of RPL554 for
hospital use is motivated in part by the increasing concern and
intent to tackle the high rates of 30-day hospital re-admissions
for COPD. This has recently gained impetus following the
implementation by the US Government in the fourth quarter of 2014
of a new policy which penalizes hospitals with high 30-day
re-admission rates for select conditions, including COPD.
Interestingly, such a policy has already been introduced by the NHS
in the UK. In our clinical studies in hospitalized patients, we
will explore the possibility that treatment with RPL554 will reduce
such re-admission rates and so demonstrate a clear health-economic
benefit of treatment with the drug.
The Board believes that products combining RPL554 with other
classes of bronchodilators are potentially highly attractive for
the respiratory market and expand the RPL554 product franchise.
Indeed, while there has been significant interest in the novel dual
bronchodilator products containing a LABA and a LAMA recently
introduced as chronic treatments for COPD, a combination between
RPL554 and, for example, the LAMA glycopyrrolate, would contain two
different bronchodilator components, with the added benefit that
RPL554 would also provide an anti-inflammatory component to create
in essence a triple-combination product.
We further plan to expand the use of RPL554 beyond COPD, and
explore the possible use of RPL554 in the treatment of other
respiratory conditions. Pre-clinical work demonstrating a
potentiating activity on CFTR suggests that cystic fibrosis could
be a potential novel indication. We will further explore this
opportunity in pre-clinical and exploratory clinical trials. In
addition, we plan to explore the possible use of nebulized RPL554
to treat acute asthma attacks in the A&E unit. When used as an
addition to standard treatment, it is expected that RPL554 would
rapidly improve lung function, reduce symptoms and reduce the
number of hospital admissions from the A&E unit. Again, this
treatment would generate a clear health-economics benefit.
The Company recognizes that an experienced and resourceful
commercial collaborator could bring significant value to the
development of RPL554 for chronic maintenance treatment in COPD and
perhaps asthma and therefore continues to be involved in business
development discussions around the RPL554 program. However, the
Company intends to collaborate in respect of its drug candidates
only when it can extract a commercially attractive return for the
Company and its Shareholders.
BOARD CHANGES
Post period; we were pleased to announce the appointment of
Mahendra Shah, Rishi Gupta, Andrew
Sinclair and Vikas Sinha, as
Non-Executive Directors to the Board. The new Board members are
highly experienced directors and entrepreneurs with invaluable
expertise in the field of drug development, commercialization,
corporate development and financial management. We very much look
forward to working with them as we continue our focused clinical
development of the lead pipeline asset RPL554.
OUTLOOK
We continue to develop the Company by exploring opportunities to
expand RPL554 across multiple disease areas and in combination with
other products to enhance our pipeline, and by recruiting
additional expertise (particularly in the development and
commercialization of respiratory products) across both our
management team and Board of Directors. The Company operates with a
strong focus and financial discipline, and with a well-financed
Balance Sheet coupled with our additional expertise we remain very
positive about progress to date in our lead drug development
program, RPL554, and the opportunities for its further development
and commercialization.
Dr. David Ebsworth |
Dr. Jan-Anders Karlsson |
Chairman |
Chief Executive Officer |
12 September 2016 |
12 September 2016 |
1 Dyspnea (shortness of breath) in COPD patients is often
associated with hyperinflation of the lungs resulting from a higher
residual volume of air
2 Pre-clinical studies in isolated airway muscle have
demonstrated that RPL554 is an effective bronchodilator also in
highly constricted airways, to some extent mimicking bronchospasm
in patients with respiratory disease, where other bronchodilators
of the currently used beta2-agonist and anti-muscarinic types are
less effective. If a similar effect is seen in patients with highly
obstructed airway muscles, RPL554 has the potential to be
advantageous compared to other types of bronchodilators.
CONDENSED CONSOLIDATED INTERIM
STATEMENT OF COMPREHENSIVE INCOME
FOR THE SIX MONTHS ENDED 30 JUNE 2016
|
|
6 months
ended |
6 months
ended |
Year ended |
|
|
30 June
2016 |
30 June
2015 |
31 December
2015 |
|
Notes |
(unaudited) |
(unaudited) |
(audited) |
|
|
£ |
£ |
£ |
|
|
|
|
|
Research and
development |
|
(1,244,715) |
(3,477,322) |
(7,268,847) |
Administration expenses |
|
(661,114) |
(987,792) |
(1,705,944) |
|
|
|
|
|
Operating loss |
|
(1,905,829) |
(4,465,114) |
(8,974,791) |
|
|
|
|
|
Finance income |
|
7,375 |
27,169 |
44,791 |
|
|
|
|
|
Loss before taxation |
|
(1,898,454) |
(4,437,945) |
(8,930,000) |
Taxation – credit |
2 |
284,977 |
743,762 |
1,509,448 |
|
|
|
|
|
Loss for the period attributable
to owners of the parent |
|
(1,613,477) |
(3,694,183) |
(7,420,552) |
Other comprehensive gains |
|
|
|
|
Exchange differences on translating
foreign operations |
|
15,866 |
5,593 |
3,784 |
|
|
|
|
|
Total Comprehensive loss for the
period attributable to owners of the parent |
|
(1,597,611) |
(3,688,590) |
(7,416,768) |
|
|
|
|
|
Loss per ordinary share – basic and
diluted (pence) |
3 |
(0.16)p |
(0.37)p |
(0.73)p |
|
|
|
|
|
CONDENSED CONSOLIDATED INTERIM
STATEMENT OF FINANCIAL POSITION
AS AT 30 JUNE
2016
|
|
As at |
As at |
As at |
|
|
30
June 2016 |
30
June 2015 |
31
December 2015 |
|
|
(unaudited) |
(unaudited) |
(audited) |
|
|
£ |
£ |
£ |
ASSETS |
|
|
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
Property, plant and equipment |
|
9,962 |
17,343 |
13,162 |
Intangible assets |
|
403,232 |
286,186 |
344,645 |
Goodwill |
|
1,469,112 |
1,469,112 |
1,469,112 |
|
|
1,882,306 |
1,772,641 |
1,826,919 |
|
|
|
|
|
Current assets |
|
|
|
|
Prepayments and other
receivables |
|
518,522 |
494,780 |
513,300 |
Current tax receivable |
|
1,824,788 |
1,385,414 |
1,534,788 |
Cash and cash equivalents |
|
1,205,724 |
6,093,913 |
3,524,387 |
|
|
3,549,034 |
7,974,107 |
5,572,475 |
|
|
|
|
|
Total assets |
|
5,431,340 |
9,746,748 |
7,399,394 |
|
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital and reserves attributable
to equity holders |
|
|
|
|
Called up share capital |
|
1,009,923 |
1,009,923 |
1,009,923 |
Share premium account |
|
26,650,098 |
26,650,098 |
26,650,098 |
Share-based payments reserve |
|
1,113,694 |
912,016 |
1,022,440 |
Retained losses |
|
(24,606,707) |
(19,396,536) |
(23,095,806) |
Total equity |
|
4,167,008 |
9,175,501 |
5,586,655 |
|
|
|
|
|
Current liabilities |
|
|
|
|
Trade and other payables |
|
1,264,332 |
571,247 |
1,812,739 |
Total liabilities |
|
1,264,332 |
571,247 |
1,812,739 |
|
|
|
|
|
Total equity and
liabilities |
|
5,431,340 |
9,746,748 |
7,399,394 |
|
|
|
|
|
CONDENSED CONSOLIDATED INTERIM
STATEMENT OF CASH FLOWS
FOR THE SIX MONTHS ENDED 30 JUNE 2016
|
|
6 months
ended |
6 months
ended |
Year ended |
|
|
30 June
2016 |
30 June
2015 |
31 December
2015 |
|
|
(unaudited) |
(unaudited) |
(audited) |
|
|
£ |
£ |
£ |
Reconciliation of operating loss to net cash outflow from
operating activities |
|
|
|
|
Operating loss |
|
(1,905,829) |
(4,465,114) |
(8,974,791) |
Exchange differences on
translating |
|
|
|
|
foreign operations |
|
15,866 |
5,593 |
3,784 |
Share based payment expense |
|
177,962 |
259,611 |
398,943 |
Decrease/(increase) in prepayments
and other receivables |
|
(5,221) |
76,153 |
57,633 |
(Decrease)/increase in
trade and other
payables |
|
(539,372) |
46,934 |
1,274,370 |
Depreciation of plant and
equipment |
|
5,095 |
4,951 |
9,854 |
Write-off of intangible assets |
|
- |
134,533 |
134,533 |
Amortization of intangible
assets |
|
26,092 |
21,688 |
43,262 |
|
|
|
|
|
Net cash outflow from operating
activities |
|
(2,225,407) |
(3,915,651) |
(7,052,412) |
Net cash outflow from operating
activities |
|
(2,225,407) |
(3,915,651) |
(7,052,412) |
|
|
|
|
|
Cash (outflow)/inflow from
taxation |
|
(14,057) |
69,150 |
699,519 |
|
|
|
|
|
Cash flow from investing
activities |
|
|
|
|
Finance income |
|
7,375 |
32,969 |
50,591 |
Purchase of property, plant and
equipment |
|
(1,838) |
(616) |
(1,830) |
Payment for patents |
|
(84,736) |
(61,698) |
(141,240) |
Net cash outflow from investing
activities |
|
(79,199) |
(29,345) |
(92,479) |
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
(2,318,663) |
(3,875,846) |
(6,445,372) |
|
|
|
|
|
Cash and cash equivalents at the
beginning of the period |
|
3,524,387 |
9,969,759 |
9,969,759 |
|
|
|
|
|
Cash and cash equivalents at the
end of the period |
|
1,205,724 |
6,093,913 |
3,524,387 |
CONDENSED CONSOLIDATED INTERIM
STATEMENT OF CHANGES IN EQUITY
FOR THE SIX MONTHS ENDED 30 JUNE 2016
|
Share |
Share |
Share-based
payment |
Retained |
|
|
capital |
premium |
reserve |
losses |
Total |
|
£ |
£ |
£ |
£ |
£ |
|
|
|
|
|
|
Balance at 1 January
2016 |
1,009,923 |
26,650,098 |
1,022,440 |
(23,095,806) |
5,586,655 |
Loss for the period |
- |
- |
- |
(1,613,477) |
(1,613,477) |
Other comprehensive income for the
period: |
|
|
|
|
|
Exchange
differences on
translating foreign operations |
- |
- |
- |
15,866 |
15,866 |
|
1,009,923 |
26,650,098 |
1,022,440 |
(24,693,417) |
3,989,044 |
Share-based payments |
- |
- |
177,962 |
- |
177,962 |
Transfer of
previously
expensed share-based payment
charge upon lapse of options |
- |
- |
(86,708) |
86,708 |
- |
Balance at 30 June 2016
(unaudited) |
1,009,923 |
26,650,098 |
1,113,694 |
(24,606,709) |
4,167,006 |
|
|
|
|
|
|
Balance at 1 January 2015 |
1,009,923 |
26,650,098 |
677,946 |
(15,733,487) |
12,604,480 |
Loss for the period |
|
|
|
(3,694,183) |
(3,694,183) |
Other comprehensive
income for the period:
Exchange differences on
translating foreign operations |
- |
- |
- |
5,593 |
5,593 |
|
1,009,923 |
26,650,098 |
677,946 |
(19,422,077) |
8,915,890 |
|
|
|
|
|
|
Share-based payments |
- |
- |
259,611 |
- |
259,611 |
Transfer of
previously
expensed share-based payment
charge upon lapse of options |
- |
- |
(25,541) |
25,541 |
- |
Balance at 30 June 2015
(unaudited) |
1,009,923 |
26,650,098 |
912,016 |
(19,396,536) |
9,175,501 |
Balance at 1 January 2015 |
1,009,923 |
26,650,098 |
677,946 |
(15,733,487) |
12,604,480 |
Loss for the year |
- |
- |
- |
(7,420,552) |
(7,420,552) |
Other comprehensive
income for the year:
Exchange differences on
translating foreign operations |
- |
- |
- |
3,784 |
3,784 |
|
1,009,923 |
26,650,098 |
677,946 |
(23,150,255) |
5,187,712 |
|
|
|
|
|
|
Share-based payments |
- |
- |
398,943 |
- |
398,943 |
Transfer of
previously
expensed share-based payment
charge upon lapse of options |
- |
- |
(54,449) |
54,449 |
- |
Balance at 31 December 2015
(audited) |
1,009,923 |
26,650,098 |
1,022,440 |
(23,095,806) |
5,586,655 |
NOTES TO THE FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 JUNE 2016
1.
Publication of non-statutory accounts
i) This interim financial
information for the six months ended 30 June
2016 is unaudited and does not constitute statutory accounts
within the meaning of Section 434 of the Companies Act 2006. It was
approved by the Board of Directors on 12
September 2016. The figures for the year ended 31 December 2015 have been extracted from the
audited statutory accounts which have been reported on by the
Company’s auditor. The financial statements for the year ended
31 December 2015 have been delivered
to the Registrar of Companies and the auditor’s report on those
financial statements was unqualified and did not contain a
statement made under section 498(2) or section 498(3) of the
Companies Act 2006.
ii) Accounting policies
The interim financial statements for the six months ended
30 June 2016 includes the results of
Verona Pharma plc and its wholly-owned subsidiaries, Verona Pharma
Inc. and Rhinopharma Limited. The unaudited results for the period
have been prepared on the basis of accounting policies adopted in
the audited accounts for the year ended 31
December 2015 and expected to be adopted in the financial
year ending 31 December 2016.
In the opinion of the Directors, the interim financial
information for the period presents fairly the financial position
and the results from operations and cash flows for the period.
No new IFRS standards, amendments or interpretations became
effective in the six months to the 30 June
2016 which had a material effect on this interim financial
information.
iii) During the period two
restatements have been made to the primary statements as
follows:
- |
Exchange differences
arising on translating foreign operations have been reclassified
from research and development to other comprehensive gains due to
an error in the prior period amounting to £5,593 (30th June 2015)
and £3,784 (31st December 2015). |
- |
Computer software has been
reclassified from property, plant and equipment to intangible
assets amounting to £603 (30 June 2016), £169 (30 June 2015) and
£660 (31 December 2015). |
The impact of both these restatements is immaterial to the
financial statements.
iv) The directors do not recommend
the payment of a dividend (period to 30 June
2015 - £Nil; year ended 31 December
2015 - £Nil).
v) A copy of the interim report is
available on the Company’s website www.veronapharma.com.
2.
Taxation
The current period tax credit, £0.28 million, represents the
estimated research and development tax credit receivable on
qualifying expenditure incurred during the six month period ended
30 June 2016.
(period to 30 June 2015: £0.74
million; year ended 31 December 2015:
£1.51 million).
3. Loss per
share
i) The basic loss per share of
0.16p (30 June 2015: loss of 0.37p;
31 December 2015: loss of 0.73p) for
the Group is calculated by dividing the loss for the period by the
weighted average number of ordinary shares in issue of
1,009,923,481 (30 June 2015:
1,009,923,481; 31 December 2015:
1,009,923,481).
ii) Since the Group has
reported a net loss, diluted loss per ordinary share is equal to
basic loss per ordinary share.
4.
Comparatives
The comparatives include audited figures for the year ended
31 December 2015 and unaudited
figures for the six months ended 30 June
2015.