TIDMVRP
Nebulized ensifentrine as add-on to dual bronchodilator therapy for COPD
demonstrated additional increase in lung function on top of maximum
current therapy in three-day Phase 2 clinical trial
Single dose of ensifentrine dry powder inhaler formulation showed
statistically significant, dose-dependent and clinically meaningful
increases in lung function in first part of two-part Phase 2 clinical
trial
LONDON, May 07, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP)
(Nasdaq: VRNA) ("Verona Pharma" or the "Company"), a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for respiratory diseases, announces today an
operational update and financial results for the three months ended
March 31, 2019.
The Company's product candidate, ensifentrine (RPL554), has the
potential to be the first novel class of bronchodilator in over 40 years,
and the first therapy for the treatment of respiratory diseases that
combines bronchodilator and anti-inflammatory activities in one
compound. Verona Pharma is conducting its final Phase 2 clinical study
with nebulized ensifentrine for the treatment of chronic obstructive
pulmonary disease ("COPD") before the end of Phase 2 meeting with the
U.S. Food and Drug Administration (FDA). The Company is planning its
Phase 3 clinical program in this indication, which it expects to
commence in 2020 following the completion of the end of Phase 2 meeting.
Verona Pharma is also developing ensifentrine for other respiratory
diseases including cystic fibrosis ("CF") and asthma.
OPERATIONAL AND DEVELOPMENT HIGHLIGHTS
Positive clinical progress with ensifentrine demonstrating additional
bronchodilation and positive safety data in Phase 2 trials in COPD.
-- Reported top-line data from three-day Phase 2 trial which enrolled 79
patients to investigate the efficacy and safety of two different doses
(1.5 mg and 6.0 mg, twice daily) of nebulized ensifentrine on top of an
inhaled LAMA/LABA therapy, tiotropium/olodaterol (Stiolto(R) Respimat(R))
for COPD maintenance treatment.
-- Ensifentrine demonstrated additional bronchodilation in patients
already receiving maximum standard-of-care dual bronchodilation
therapy with an inhaled LAMA/LABA therapy.
-- Although the primary endpoint of statistically significant
improvement in peak forced expiratory volume in one second
("FEV1") following the morning dose when added on top of LAMA/LABA
compared to placebo was not met, the average FEV1 of 50 ml during
the first 4 hours of dosing with 1.5 mg was statistically
significant (p=0.039).
-- Statistically significant improvements in evening peak FEV1 on the
third day of dosing, and significant reductions in lung volume
after the evening dose of ensifentrine were observed with both the
1.5 mg (P<0.001) and 6 mg (P=0.002) dose groups, compared to
placebo, when administered on top of LAMA/LABA.
-- This improvement in FEV1 with the 1.5 mg (P<0.05) dose was
maintained throughout the 24-hour period as measured on day 3.
-- Ensifentrine was observed to be well tolerated in this study.
-- Reported positive interim bronchodilation and safety data from part one
of a two-part Phase 2 clinical trial of a dry powder inhaler ("DPI")
formulation of ensifentrine in 37 patients with moderate-to-severe COPD
that received a single dose of one (out of five) dosage strengths of
ensifentrine (150 ug, 500 ug, 1500 ug, 3000 ug, or 6000 ug) or placebo.
-- Interim data showed a statistically significant and clinically
meaningful increase in lung function as measured by FEV1, compared
to placebo.
-- Peak FEV1 increased from baseline in a dose-dependent manner
(ranging from 68 mL to 333 mL, p<0.05 for doses 1500 ug and
above).
-- Average FEV1 0-12 hours also showed a dose response and
demonstrated durability of effect over the dosing interval
(average FEV1 0-12h: ranging from 54 mL to 254 mL, p<0.05 for
doses 1500 ug and above) supporting twice-daily dosing.
-- Ensifentrine DPI formulation was observed to be well tolerated at
each dose with an adverse event profile similar to placebo.
-- The data supported initiation of the second part of the Phase 2
trial to evaluate the ensifentrine DPI formulation in patients
with moderate-to-severe COPD over one week of twice-daily
treatment. Top-line data from this study is now expected in the
third quarter of 2019, sooner than previously indicated.
-- Strengthened the management team through the additions of Kathleen
Rickard, MD, as Chief Medical Officer, and Tara Rheault, PhD, MPH, as
Vice President of Research and Development Operations and Global Project
Management.
Post-period end, the Company:
-- Initiated a Phase 2b dose ranging study evaluating nebulized ensifentrine
as an add-on to treatment with a long acting bronchodilator in patients
with moderate-to-severe COPD. The Company anticipates completing patient
dosing by the end of 2019.
-- The four-week, randomized, double-blind, placebo-controlled
dose-ranging trial is designed to evaluate the safety and efficacy
of nebulized ensifentrine as an add-on to inhaled tiotropium, a
LAMA commonly used to treat COPD, and to establish the dosing
regimen for a potential Phase 3 program in COPD.
-- The study will enroll approximately 400 patients with COPD at a
number of sites in the US.
-- The primary endpoint of this study is improvement in lung function
with ensifentrine, as measured by FEV1 from 0 to 3 hours, a
standard measure of exhaled breath volume. Key additional
endpoints include measurements of respiratory symptoms and quality
of life via different patient reported outcome tools.
-- Deepened the expertise on the Board through the appointment of Dr Martin
Edwards as an independent Non-executive Director.
-- Granted a key EU patent that provides intellectual property protection
throughout Europe out to 2035 for a suspension formulation of
ensifentrine suitable for nebulized administration. A corresponding
patent has already issued in the US.
-- Plans to host an "Investor and Analyst R&D Forum" on May 8, 2019 in
London, to provide insights into the unmet medical need and challenges of
treating COPD, as well as an update of the most recent clinical data on
ensifentrine. The forum will feature a panel of Key Opinion Leaders in
the field of COPD to provide the clinicians' perspective, as well as a
COPD patient to provide a patient's perspective and a webcast will be
available for a period of 30 days following the event
at:http://investors.veronapharma.com.
FINANCIAL HIGHLIGHTS
-- Net cash, cash equivalents and short term investments at March 31, 2019
amounted to GBP54.0 million (December 31, 2018: GBP64.7 million).
-- For the three months ended March 31, 2019, reported operating loss of
GBP7.8 million (three months ended March 31, 2018: GBP5.9 million) and
reported loss after tax of GBP5.4 million (three months ended March 31,
2018: GBP15.3 million). Operating expenses increased due to an expansion
of research and development activity. The decrease in net loss for the
three months ended March 31, 2019 included within finance income an
amount of GBP1.6 million relating to a reduction in the fair value of the
liability representing the outstanding warrants to purchase Verona Pharma
shares. This compared to the three months ended March 31, 2018 when the
fair value of the warrants increased by GBP9.0 million, which was
recorded within finance expense. These movements in the fair value of the
warrant liability were non-cash items.
-- Reported loss per share of 5.1 pence for the three months ended March 31,
2019 (three months ended March 31, 2018: 14.5 pence).
-- Net cash used in operating activities for the three months ended March
31, 2019 was GBP9.9 million (three months ended March 31, 2018: GBP6.2
million) reflecting increased clinical activities and the timing of
supplier payments.
"The Phase 2b clinical trial with nebulized ensifentrine for COPD has
begun as planned and we anticipate completing patient dosing in this
study by the end of 2019. We then plan to advance into our Phase 3
clinical trial program, which we expect to commence in 2020 following
the completion of the end of Phase 2 meeting with the FDA," commented
Jan-Anders Karlsson, PhD, CEO of Verona Pharma.
"We reported positive interim data from our first inhaler study which
opens an opportunity to provide an ensifentrine inhaler to the millions
of COPD patients who prefer to use a handheld inhaler device. We believe
this is a very attractive commercial opportunity."
Conference Call and Webcast Information
Verona Pharma will host an investment community conference call at 8:00
a.m. Eastern Daylight Time (1:00 pm British Summer Time) on Tuesday, May
7, 2019. Analysts and investors may participate in the conference call
by utilizing the conference ID: 13689539 and dialing the following
numbers:
-- 877-423-9813 or 201-689-8573 for callers in the United States
-- 0800 756 3429 for callers in the United Kingdom
-- 0800 182 0040 for callers in Germany
Those interested in listening to the conference call live via the
internet may do so by visiting the "Investors" page of Verona Pharma's
website at www.veronapharma.com and clicking on the webcast link. A
webcast replay of the conference call [audio] will be available for 30
days by visiting the "Investors" page of Verona Pharma's website at
www.veronapharma.com and clicking on the "Events and presentations"
link.
An electronic copy of the interim results will be made available today
on the Company's website (www.veronapharma.com). This press release does
not constitute an offer to sell or the solicitation of an offer to buy
any of the Company's securities, and shall not constitute an offer,
solicitation or sale in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of that jurisdiction.
This press release contains inside information for the purposes of
Article 7 Regulation (EU) No. 596/2014.
About COPD
COPD is a progressive and life-threatening respiratory disease without a
cure. The World Health Organization estimates that it will become the
third leading cause of death worldwide by 2030. The condition damages
the airways and the lungs, leading to debilitating breathlessness that
has a devastating impact on performing basic daily activities such as
getting out of bed, showering, eating and walking. In the United States
alone, the 2010 total annual medical costs related to COPD were
estimated to be $32 billion and are projected to rise to $49 billion in
2020. About 800,000 US COPD patients on dual/triple inhaled therapy
(LAMA/LABA +/- ICS) remain uncontrolled, experiencing symptoms that
impair quality of life. These patients urgently need better treatments.
About Verona Pharma plc
Verona Pharma is a clinical-stage biopharmaceutical company focused on
developing and commercializing innovative therapies for the treatment of
respiratory diseases with significant unmet medical needs. Verona
Pharma's product candidate, ensifentrine (RPL554), is a first-in-class,
inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that
has been shown to act as both a bronchodilator and an anti-inflammatory
agent in a single compound. Ensifentrine is currently in Phase 2b
clinical development for the maintenance treatment of COPD and is
planned to enter Phase 3 trials for this indication in 2020. Verona
Pharma is also developing ensifentrine for the treatment of cystic
fibrosis and asthma.
Forward Looking Statements
This press release, operational review, outlook and financial review
contain forward-looking statements. All statements contained in this
press release, operational review, outlook and financial review that do
not relate to matters of historical fact should be considered
forward-looking statements, including, but not limited to, statements
regarding ensifentrine as a first-in-class product candidate, the timing
of clinical trials of ensifentrine and trial results, the Company's
"Investor and Analyst R&D Forum," the market opportunity for an
ensifentrine inhaler, ensifentrine as the first novel class of
bronchodilator in over 40 years and the first therapy for the treatment
of respiratory diseases that combines bronchodilator and
anti-inflammatory activities in one compound, the treatment potential of
ensifentrine, improvements in air trapping on top of dual bronchodilator
treatment translating into further symptom improvement in patients
already on maximum standard-of-care therapy, the market potential for
ensifentrine in a handheld inhaler formulation, the value of
ensifentrine for COPD patients who remain symptomatic and uncontrolled
despite treatment with currently available medicine, the number of COPD
patients who use inhalers for maintenance therapy, the expansion of the
market for ensifentrine in a DPI or pMDI formulation and the size of
such market, our goal to become a leading biopharmaceutical company, our
review of, and the data from, our next dose ranging Phase 2b study to
facilitating and de-risking dose selection for our Phase 3 program and
further enhancing ensifentrine's commercial positioning, the treatment
potential for ensifentrine in other respiratory disease, strategic
collaborations and their value, and in-licensing additional product
candidates.
These forward-looking statements are based on management's current
expectations. These statements are neither promises nor guarantees, but
involve known and unknown risks, uncertainties and other important
factors that may cause our actual results, performance or achievements
to be materially different from our expectations expressed or implied by
the forward-looking statements, including, but not limited to, the
following: our limited operating history; our need for additional
funding to complete development and commercialization of ensifentrine,
which may not be available and which may force us to delay, reduce or
eliminate our development or commercialization efforts; the reliance of
our business on the success of ensifentrine, our only product candidate
under development; economic, political, regulatory and other risks
involved with international operations; the lengthy and expensive
process of clinical drug development, which has an uncertain outcome;
serious adverse, undesirable or unacceptable side effects associated
with ensifentrine, which could adversely affect our ability to develop
or commercialize ensifentrine; potential delays in enrolling patients,
which could adversely affect our research and development efforts; we
may not be successful in developing ensifentrine for multiple
indications; our ability to obtain approval for and commercialize
ensifentrine in multiple major pharmaceutical markets; misconduct or
other improper activities by our employees, consultants, principal
investigators, and third-party service providers; the loss of any key
personnel and our ability to recruit replacement personnel, material
differences between our "top-line" data and final data; our reliance on
third parties, including clinical investigators, manufacturers and
suppliers, and the risks related to these parties' ability to
successfully develop and commercialize ensifentrine; and lawsuits
related to patents covering ensifentrine and the potential for our
patents to be found invalid or unenforceable.
These and other important factors under the caption "Risk Factors" in
our Annual Report on Form 20-F filed with the Securities and Exchange
Commission ("SEC") on March 19, 2019, and our other reports filed with
the SEC, could cause actual results to differ materially from those
indicated by the forward-looking statements made in this press release,
operational review, outlook and financial review. Any such
forward-looking statements represent management's estimates as of the
date of this press release and operational and financial review. While
we may elect to update such forward-looking statements at some point in
the future, we disclaim any obligation to do so, even if subsequent
events cause our views to change. These forward-looking statements
should not be relied upon as representing our views as of any date
subsequent to the date of this press release, operational review,
outlook and financial review.
For further information please contact:
Verona Pharma plc Tel: +44 (0)20 3283 4200
Jan-Anders Karlsson, Chief Executive Officer info@veronapharma.com
Victoria Stewart, Director of Communications
N+1 Singer Tel: +44 (0)20 3283 4200
(Nominated Adviser and UK Broker)
Aubrey Powell / Jen Boorer / Iqra Amin (Corporate
Finance)
Mia Gardner (Corporate Broking)
Optimum Strategic Communications Tel: +44 (0)20 3922 0891
(European Media and Investor Enquiries) verona@optimumcomms.com
Mary Clark / Anne Marieke Ezendam / Hollie Vile
Westwicke, an ICR Company
(US Media and Investor enquiries)
Darcie Robinson Tel: +1 203-919-7905
Darcie.Robinson@icrinc.com
Stephanie Carrington Tel: +1 646 277 1282
Stephanie.Carrington@icrinc
.com
OPERATIONAL REVIEW
Company overview
Verona Pharma is a clinical-stage biopharmaceutical company focused on
developing and commercializing innovative therapies for the treatment of
respiratory diseases with significant unmet medical needs. Verona
Pharma's product candidate, ensifentrine, is an investigational
potential first-in-class, inhaled, dual inhibitor of the enzymes
phosphodiesterase 3 and 4 that has been demonstrated to have both
bronchodilator and anti-inflammatory effects in a single compound. We
believe ensifentrine has the potential to be the first novel class of
bronchodilator in over 40 years, and the first therapy for the treatment
of respiratory diseases that combines bronchodilator and
anti-inflammatory activities in one compound. Verona Pharma is
developing ensifentrine for the treatment of COPD, CF, and asthma and
potentially other respiratory diseases.
In clinical trials, the nebulized formulation of ensifentrine has been
observed to result in bronchodilator effects when used alone or as an
add-on treatment to other COPD bronchodilators. It has shown clinically
meaningful and statistically significant improvements in lung function
when administered in addition to frequently used short- and long-acting
bronchodilators, such as tiotropium (Spiriva(R) ), compared with such
bronchodilators administered as a single agent. Ensifentrine improved
FEV(1) over four weeks in patients with moderate-to-severe COPD when
compared to placebo and improved COPD symptoms and quality of life in a
Phase 2b multicenter European study performed in 403 patients. In
addition, ensifentrine has shown anti-inflammatory effects in a standard
challenge model producing COPD-like inflammation in human subjects. In a
recent three day clinical pharmacology study, ensifentrine was observed
to significantly increase bronchodilation, compared to placebo, even in
patients already on background treatment of LAMA/LABA dual
bronchodilator therapy, with or without inhaled steroids. The
improvement in lung function following a 1.5 mg dose of ensifentrine was
statistically significant over a number of time points, including over
the first 4 hours after the morning dose, over 24 hours and after the
evening dose, despite the primary endpoint of improvement at morning
peak not having been met. Importantly, ensifentrine produced clinically
relevant and statistically significant improvements in air trapping
(residual volume) on top of dual bronchodilator treatment, which we
believe may translate into further symptom improvement in these patients
already on maximum standard-of-care therapy. Ensifentrine has been
observed to be well tolerated in these studies, having been administered
to more than 800 subjects in 13 clinical trials.
Verona Pharma is also developing formulations of ensifentrine suitable
for handheld inhaler devices, in both dry powder inhaler ("DPI") and
pressurized metered-dose inhaler ("pMDI") formats. We recently announced
data from Part 1 of our DPI study (administering a single ascending dose
of ensifentrine in moderate-to-severe COPD patients), showing clear dose
dependent and statistically significant improvements in bronchodilation
compared to placebo, while observed to be well tolerated. We now expect
to announce further data from Part 2 of this study sooner than
previously indicated, in the third quarter of 2019. In the current
quarter we also expect to commence a pMDI study in moderate-to-severe
COPD patients, with single dose data from Part 1 of this study expected
in the second half of 2019 and final data expected in the first quarter
of 2020. We believe the availability of a handheld inhaler will greatly
expand the market potential for ensifentrine to the millions of COPD
patients who prefer to use handheld devices.
Despite treatment with currently approved therapies, many patients with
COPD experience daily symptoms impairing their quality of life. Airway
obstruction and air trapping due to narrow air passages are major causes
of debilitating breathlessness (dyspnoea), reducing physical ability and
causing anxiety and depression. Of the patients treated with dual
bronchodilator (LAMA/LABA) and triple therapy (LAMA/LABA/ICS), research
suggests that up to 40% (approximately 800,000 patients in the US alone)
are uncontrolled, remaining symptomatic and at an increased risk of
exacerbations.
We believe ensifentrine has demonstrated improvement in lung function,
as measured by FEV(1) , and symptoms (which commonly are a precursor to
exacerbations) in clinical trials, and may therefore be an attractive
additional treatment for these uncontrolled patients. Furthermore, in
COPD patients, novel anti-inflammatory therapies are required as current
treatments such as ICS and PDE4 inhibitors are either effective only in
specific subsets of exacerbating COPD patients or are associated with
distressing side effects which can reduce treatment compliance. We have
already observed that ensifentrine improves lung function, as measured
by FEV(1) and/or Residual Volume, when used either as a stand-alone
treatment or as an addition to single or dual bronchodilators and we
believe it is well placed to potentially meet the need for an effective
and well tolerated additional treatment for those COPD patients who
remain symptomatic and uncontrolled despite using currently available
COPD medications.
Operational performance in the first quarter
On January 14, 2019, we announced top-line data from an exploratory
Phase 2a double blind, placebo-controlled, three way cross-over trial in
79 subjects with COPD, which included two different doses of
ensifentrine, 1.5 mg and 6 mg, or placebo, dosed twice-daily for three
days, in addition to a dual bronchodilator therapy comprising tiotropium
and olodaterol, a commonly used LAMA/LABA, dosed once daily. This
clinical trial evaluated the efficacy and safety of ensifentrine dosed
on top of LAMA/LABA and LAMA/LABA/ICS, a high hurdle as patients already
on maximum bronchodilator treatment have very few treatment
alternatives. It was conducted in the United States and United Kingdom.
We reported top-line data from this trial earlier than expected, in
January 2019. The data from this Phase 2a trial demonstrated significant
improvements in lung function with the 1.5 mg dose over periods of 0-4
hours, 0-12 hours and 0-24 hours following the morning dose, and on peak
effect following the evening dose, when ensifentrine was added to
tiotropium and olodaterol in patients with moderate-to-severe COPD,
despite not meeting the primary endpoint of an improvement in the
morning peak lung function.
-- Improvement in average FEV1 (additional bronchodilation) following
morning dose on the third day with 1.5 mg of ensifentrine was
statistically significant when added on top of Stiolto(R) (tiotropium
plus olodaterol or LAMA/LABA) compared to placebo over 0 - 4 hours
(p=0.039), and 0 - 24 hours (p=0.02);
-- Ensifentrine, compared to placebo, produced a statistically significant
improvement in evening peak FEV1 on the third day of dosing (additional
bronchodilation) when administered on top of the standard bronchodilator
tiotropium plus olodaterol (Stiolto(R)) (1.5 mg, p<0.001; 6 mg p=0.002);
and
-- Ensifentrine, compared to placebo, produced a statistically significant
improvement in residual volume on the third day of dosing when
administered on top of the standard bronchodilator tiotropium plus
olodaterol (Stiolto(R)) following the morning dose (1.5 mg, p=0.037, 6 mg
N/S) and the evening dose (1.5 mg, p<0.002; 6 mg p<0.036).
In addition to our nebulized formulation of ensifentrine, we are also
developing ensifentrine in both DPI and pMDI formulations for the
maintenance treatment of COPD patients who prefer to use a handheld
inhaler device. We estimate that, in the US, approximately 90% of the
3.7 million mild/moderate COPD patients and 80% of the 2.7 million
severe/very severe COPD patients use inhalers for maintenance therapy.
We believe that the successful development of a DPI or pMDI formulation
of ensifentrine for moderate disease would greatly expand the
addressable market for the drug and represents a multi-billion dollar
potential opportunity.
On March 4, 2019 we announced interim data from Part 1 of our DPI study
(administering a single ascending dose of ensifentrine in
moderate-to-severe COPD patients) showing a clear dose response with
statistically significant improvements in bronchodilation compared to
placebo at the higher doses studies. We now expect to announce further
data from Part 2 of this study sooner than previously indicated, in the
third quarter of 2019. The study is designed in two parts: in Part 1, 37
patients were randomized and given a single dose of ensifentrine, in
doses ranging from 150 - 6,000 ug.
-- Peak FEV1 increased from baseline in a dose-dependent manner (ranging
from 68 mL to 333 mL, p<0.05 for doses 1500 ug and above);
-- Average FEV1 0-4 hours and 0-12 hours also showed a dose response and
demonstrated durability of effect over the dosing interval (average
FEV10-4h: ranging from 68 mL to 296 mL, p<0.05 for doses 500 ug and
above; average FEV1 0-12h: ranging from 54 mL to 254 mL, p<0.05 for doses
1500 ug and above, supporting twice-daily dosing).
-- Ensifentrine DPI formulation has been observed to be well tolerated at
each dose with an adverse event profile similar to placebo.
In the current quarter we expect to commence a pMDI study in moderate to
severe COPD patients, with single dose data from Part 1 of this study
expected in the second half of 2019 and final data expected in the first
quarter of 2020.
Opportunities also exist to explore the development of ensifentrine in
DPI and/or pMDI formulations for the treatment of asthma and other
respiratory diseases.
OUTLOOK
We intend to become a leading biopharmaceutical company focused on the
treatment of respiratory diseases with significant unmet medical needs.
We recognize that our proposed strategy for achieving this goal depends
on the totality of the data from all clinical trials conducted with
ensifentrine, future interactions with regulatory authorities and our
commercial assessment of different development options for ensifentrine.
Key elements of this strategy include:
-- A strong focus on bringing nebulized ensifentrine into Phase 3 clinical
trials for the maintenance treatment of COPD, which requires us to deploy
our financial and other resources on nebulized and inhaled formulations
of ensifentrine as a maintenance treatment for COPD in the short term.
-- Identifying compelling market opportunities such as patients with COPD
that continue to experience daily symptoms impairing their quality of
life, despite treatment with currently available medicines. In our
clinical trials, we have observed that ensifentrine improves lung
function in COPD patients when used either as a stand-alone treatment or
as an add-on to treatment with single and dual bronchodilators. We
believe that adding nebulized ensifentrine to symptomatic COPD patients
already treated with standard-of-care medicines represents a very
significant market opportunity.
-- Ongoing review of our ensifentrine development strategy in the context of
additional data generated, including from clinical trials, regulatory
interactions and market research, to identify opportunities to enhance
and de-risk our late-stage development and commercialization of
ensifentrine. We believe this review and data from our next dose ranging
Phase 2b study to generate additional data to facilitate and de-risk dose
selection for our Phase 3 program will further enhance ensifentrine's
potential commercial positioning. We continue to expect to complete
patient dosing in our Phase 2 study by the end of 2019 and to progress
into pivotal Phase 3 trials in 2020.
-- For the treatment of COPD patients who may prefer administration using a
handheld inhaler device, we are developing ensifentrine in inhaler
formulations. We are progressing Part 2 of our clinical trial in COPD
patients with multiple doses of our DPI formulation and now expect final
data sooner than previously indicated, in the third quarter of 2019. We
expect to commence a clinical trial with the pMDI formulation this
quarter, with interim data from the single dose Part 1 expected in the
third quarter of 2019 and final data expected in the first quarter of
2020.
-- Advance the development of nebulized ensifentrine for the treatment of
acute exacerbations of COPD. We are developing ensifentrine as an add-on
therapy to short acting bronchodilators and other commonly used therapies
for the treatment of hospitalized patients with acute exacerbations of
COPD. The timing for future studies in this indication remains subject to
our decision to move more rapidly towards Phase 3 clinical trials with
nebulized ensifentrine for the maintenance treatment of COPD.
-- Develop ensifentrine for the treatment of CF. The timing for future
studies in this indication remains subject to our decision to move more
rapidly towards Phase 3 clinical trials with nebulized ensifentrine for
the maintenance treatment of COPD.
-- Pursue development of ensifentrine for other respiratory diseases. We
believe that ensifentrine's properties as an inhaled, dual inhibitor of
PDE3 and PDE4 give it broad potential applicability in the treatment of
other respiratory diseases, such as severe asthma. We may explore
development of ensifentrine to treat other forms of respiratory disease
following development of ensifentrine for the treatment of COPD and CF.
-- We may seek strategic collaborations with market leading
biopharmaceutical companies to develop and commercialize ensifentrine. We
believe any such collaborations could provide significant funding to
advance the development of ensifentrine while allowing us to benefit from
the development or commercialization expertise of our collaborators.
-- We may acquire or in-license product candidates for the treatment of
respiratory diseases. We plan to leverage our respiratory disease
expertise to identify and in-license or acquire additional clinical stage
product candidates that we believe have the potential to become novel
treatments for respiratory diseases with significant unmet medical needs.
FINANCIAL REVIEW
Financial review of the three month period ended March 31, 2019
The operating loss for the three months ended March 31, 2019, was GBP7.8
million (March 31, 2018: GBP5.9 million) and the loss after tax for the
three months ended March 31, 2019, was GBP5.4 million (March 31, 2018:
GBP15.2 million).
Research and Development Costs
Research and development costs were GBP5.9 million for the three months
ended March 31, 2019, as compared to GBP4.4 million for the three months
ended March 31, 2018, an increase of GBP1.5 million. The increase was
predominantly attributable to a GBP1.3 million increase in clinical
trial expenses relating to four clinical trials (ongoing or in
preparation) of ensifentrine in the three months ended March 31, 2019
compared to one trial in the three months ended March 31, 2018. In
addition, spend on pre-clinical development increased by GBP0.2 million.
General and Administrative Costs
General and administrative costs were GBP1.8 million for the three
months ended March 31, 2019, as compared to GBP1.5 million for the three
months ended March 31, 2018, an increase of GBP0.3 million. The increase
was primarily attributable to a GBP0.3 million increase in professional
fees.
Finance Income and Expense
Finance income was GBP1.9 million for the three months ended March 31,
2019, and GBP0.2 million for the three months ended March 31, 2018. The
increase in finance income was primarily due to a decrease in the fair
value of the warrant liability of GBP1.6 million during the three months
ended March 31, 2019 compared to an increase in the warrant liability
during the three months ended March 31, 2018, (which is recorded as a
finance expense).
Finance expense was GBP0.8 million for the three months ended March 31,
2019, compared to GBP10.3 million for the three months ended March 31,
2018. The decrease was due to a decrease in the fair value of the
warrant liability (recorded in finance income) compared to an increase
in the value of the warrant liability during the three months ended
March 31, 2018 of GBP9.0 million. In addition, there was a foreign
exchange loss on cash and short term investments of GBP0.8 million
(three months end March 31, 2018: loss of GBP1.3 million).
Taxation
Taxation for the three months ended March 31, 2019, amounted to a credit
of GBP1.3 million compared to a credit of GBP0.8 million for the three
months ended March 31, 2018, an increase of GBP0.5 million. The credits
are obtained at a rate of 14.5% of 230% of our qualifying research and
development expenditure and the increase in the credit amount was
attributable to our increased expenditure on research and development,
compared to the prior period.
Cash Flows
Net cash used in operating activities increased to GBP9.9 million for
the three months ended March 31, 2019, from GBP6.2 million for the three
months ended March 31, 2018. This was due to an increase in operating
costs driven by higher research and development costs, as well as
differences in the timing of supplier payments.
Net cash generated from investing activities predominantly reflects the
net movement of cash being placed on deposit for more than three months
and such deposits maturing, because deposits of more than three months
are disclosed as short term investments, separately from cash. The
increase in net cash generated in investing activities to GBP9.0 million
for the three months ended March 31, 2019, from GBP4.5 million for the
three months ended March 31, 2018, was due to the net movement of funds
from short term investments to cash being greater during the three
months ended March 31, 2019.
Cash, cash equivalents and short-term investments
Cash, cash equivalents and short-term investments at March 31, 2019,
decreased to GBP54.0 million from GBP64.7 million at December 31, 2018
due to the utilization of cash in the ordinary operating activities and
the effect of the GBP exchange rate strengthening on our USD cash and
cash equivalents and short term investments.
Net assets
Net assets decreased to GBP58.1 million in the three month period ended
March 31, 2019, from GBP62.9 million at December 31, 2018. This decrease
was primarily due to the operating activities of the Company.
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
AS OF MARCH 31, 2019 AND DECEMBER 31, 2018 (UNAUDITED)
As of As of
March 31, December
Notes 2019 31, 2018
---------- -----------
GBP'000s GBP'000s
ASSETS
Non-current assets:
Goodwill 441 441
Intangible assets 2,171 2,134
Property, plant and equipment 270 21
Total non-current assets 2,882 2,596
--------- --------
Current assets:
Prepayments and other receivables 2,476 2,463
Current tax receivable 5,808 4,499
Short term investments 10 35,309 44,919
Cash and cash equivalents 18,726 19,784
Total current assets 62,319 71,665
--------- --------
Total assets 65,201 74,261
========= ========
EQUITY AND LIABILITIES
Capital and reserves attributable to
equity holders:
Share capital 5,266 5,266
Share premium 118,862 118,862
Share-based payment reserve 8,543 7,923
Accumulated loss (74,556) (69,117)
--------- --------
Total equity 58,115 62,934
--------- --------
Current liabilities:
Derivative financial instrument 11 882 2,492
Finance lease liabilities 241 --
Trade and other payables 4,850 7,733
Total current liabilities 5,973 10,225
--------- --------
Non-current liabilities:
Assumed contingent obligation 12 1,018 996
Deferred income 95 106
Total non-current liabilities 1,113 1,102
--------- --------
Total equity and liabilities 65,201 74,261
========= ========
The accompanying notes form an integral part of these consolidated
financial statements.
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME
FOR THE THREE MONTHSED MARCH 31, 2019 AND MARCH 31, 2018 (UNAUDITED)
Three Months Three Months
Ended March Ended March
Notes 31, 2019 31, 2018
-------------- --------------
GBP'000s GBP'000s
Research and development costs (5,928) (4,421)
General and administrative costs (1,831) (1,458)
-------- --- ---------
Operating loss (7,759) (5,879)
Finance income 7 1,860 160
Finance expense 7 (820) (10,324)
-------- --- ---------
Loss before taxation (6,719) (16,043)
Taxation -- credit 8 1,313 820
-------- ---- --------- ---
Loss for the year (5,406) (15,223)
Other comprehensive loss:
Items that might be subsequently reclassified to profit
or loss
-------------- --------------
Exchange differences on translating foreign operations (13) (27)
-------- --- ---------
Total comprehensive loss attributable to owners of
the Company (5,419) (15,250)
======== === =========
Loss per ordinary share -- basic and diluted (pence) 9 (5.1) (14.5)
The accompanying notes form an integral part of these consolidated
financial statements.
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY
FOR THE THREE MONTHSED MARCH 31, 2018, AND MARCH 31, 2019
(UNAUDITED)
Share- Total
Share Share based Accumulated Total
Note Capital Premium Expenses Losses Equity
-------- -------- --------- -------------- ----------
GBP'000s GBP'000s GBP'000s GBP'000s GBP'000s
Balance at
January 1,
2018 5,251 118,862 5,022 (49,254) 79,881
-------- -------- --------- --------- -------
Loss for the
year -- -- -- (15,223) (15,223)
Other
comprehensive
loss for the
year:
Exchange
differences
on
translating
foreign
operations -- -- -- (27) (27)
-------- -------- --------- --------- -------
Total
comprehensive
loss for the
period -- -- -- (15,250) (15,250)
Share-based
payments -- -- 1,019 -- 1,019
-------- -------- --------- --------- --- -------
Balance at
March 31,
2018 5,251 118,862 6,041 (64,504) 65,650
======== ======== ========= ========= =======
Balance at
January 1,
2019 as
previously
reported 5,266 118,862 7,923 (69,117) 62,934
-------- -------- --------- --------- -------
Impact of
change in
accounting
policy 3 -- -- -- (20) (20)
Adjusted
balance at
January 1,
2019 5,266 118,862 7,923 (69,137) 62,914
-------- -------- --------- --------- -------
Loss for the
year -- -- -- (5,406) (5,406)
Other
comprehensive
loss for the
year:
Exchange
differences
on
translating
foreign
operations -- -- -- (13) (13)
-------- -------- --------- --------- -------
Total
comprehensive
loss for the
period -- -- -- (5,419) (5,419)
Share-based
payments -- -- 620 -- 620
-------- -------- --------- --------- --- -------
Balance at
March 31,
2019 5,266 118,862 8,543 (74,556) 58,115
======== ======== ========= ========= =======
The currency translation reserve for March 31, 2018, and March 31, 2019,
is not considered material and as such is not presented in a separate
reserve but is included in the total accumulated losses reserve.
The accompanying notes form an integral part of these consolidated
financial statements.
VERONA PHARMA PLC
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHSED MARCH 31, 2019 AND MARCH 31, 2018 (UNAUDITED)
Three Months Three Months
Ended March Ended March
31, 2019 31, 2018
-------------- --------------
GBP'000s GBP'000s
Cash used in operating activities:
Loss before taxation (6,719) (16,043)
Finance income (1,860) (160)
Finance expense 820 10,324
Share-based payment charge 620 1,019
Decrease in prepayments and other receivables 84 35
Decrease in trade and other payables (2,899) (1,434)
Depreciation of property, plant and equipment 78 2
Unrealized foreign exchange gains (11) --
Amortization of intangible assets 24 21
--------- --- --------- ---
Net cash used in operating activities (9,863) (6,236)
--------- ---------
Cash flow from investing activities:
Interest received 125 65
Purchase of plant and equipment (2) (1)
Payment for patents and computer software (61) (140)
Purchase of short term investments -- (3,858)
Maturity of short term investments 8,972 8,386
--------- --- --------- ---
Net cash generated in investing activities 9,034 4,452
--------- --- --------- ---
Cash flow from financing activities:
Repayment of finance lease liabilities (84) --
--------- --------- ---
Net cash used in financing activities (84) --
--------- --------- ---
Net decrease in cash and cash equivalents (913) (1,784)
Cash and cash equivalents at the beginning of the
period 19,784 31,443
Effect of exchange rates on cash and cash
equivalents (145) (646)
--------- ---------
Cash and cash equivalents at the end of the period 18,726 29,013
========= === ========= ===
VERONA PHARMA PLC
NOTES TO THE CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR THE THREE MONTHSED MARCH 31, 2019
1. General information
Verona Pharma plc (the "Company") and its subsidiaries are a
clinical-stage biopharmaceutical company focused on developing and
commercializing innovative therapeutics for the treatment of respiratory
diseases with significant unmet medical needs.
The Company is a public limited company, which is dual listed, with its
ordinary shares listed on the Alternative Investment Market of the
London Stock Exchange and its American Depositary Shares on the Nasdaq
Global Market. The Company is incorporated and domiciled in the United
Kingdom. The address of the registered office is 1 Central Square,
Cardiff, CF10 1FS, United Kingdom.
The Company has two subsidiaries, Verona Pharma Inc. and Rhinopharma
Limited ("Rhinopharma"), both of which are wholly owned.
2. Basis of accounting
The unaudited condensed consolidated interim financial statements of
Verona Pharma Plc and its subsidiaries, Verona Pharma, Inc., and
Rhinopharma Limited (together "the Group"), for the three months ended
March 31, 2019 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 of December 31, 2018.
The 2018 accounts, on which the Company's auditors delivered an
unqualified audit report, have been delivered to the Registrar of
Companies.
These unaudited condensed interim financial statements were authorized
for issue by the Company's board of directors (the "Directors") on May
7, 2019. There have been no changes, other than the adoption of IFRS 16,
to the accounting policies as contained in the annual consolidated
financial statements as of and for the year ended December 31, 2018,
which have been prepared in accordance with international financial
reporting standards ("IFRS") as issued by the International Accounting
Standards Board ("IASB").
The interim condensed consolidated financial statements have been
prepared on a going-concern basis. Management, having reviewed the
future operating costs of the business in conjunction with the cash held
as of March 31, 2019, believes the Group has sufficient funds to
continue as a going concern for at least 12 months from the date this
report is issued.
The Group's activities and results are not exposed to any seasonality.
The Group operates as a single operating and reportable segment.
Dividend
The Directors do not recommend the payment of a dividend for the three
months ended March 31, 2019, (three months ended March 31, 2018: GBPnil
and the year ended December 31, 2018: GBPnil).
3. Change in accounting policy: adoption of IFRS 16
IFRS 16 'Leases' is effective for accounting periods beginning on or
after January 1, 2019, and replaces IAS 17 'Leases'. It eliminates the
classification of leases as either operating leases or finance leases
and, instead, introduces a single lessee accounting model. The adoption
of IFRS 16 resulted in the Group recognizing lease liabilities within
current liabilities, and corresponding 'right-of-use' assets for the
arrangements within property plant and equipment that were previously
classified as operating leases.
The Group's principal lease arrangements are for office buildings. The
Group has adopted IFRS 16 retrospectively with the cumulative effect of
initially applying the standard as an adjustment to the opening balance
of retained earnings at January 1, 2019. The standard permits a choice
on initial adoption, on a lease-by-lease basis, to measure the
right-of-use asset at either its carrying amount as if IFRS 16 had been
applied since the commencement of the lease, or an amount equal to the
lease liability, adjusted for any accrued or prepaid lease payments. The
Group has elected to measure the right-of-use asset at its carrying
value as if IFRS 16 had been applied since the commencement of the lease,
with the result of a GBP20 thousand impact on opening retained earnings.
Initial adoption has resulted in the recognition of right-of-use assets
of GBP325 thousand and lease liabilities of GBP316 thousand and the
reclassification of prepaid lease rentals of GBP29 thousand.
As of
January 1,
2019
-------------
GBP'000s
Operating lease commitments (including prepayments)
disclosed as at December 31, 2018 600
Less: adjustments relating to prepaid lease payments (29)
---------
Operating lease commitments as at December 31, 2018 571
---------
Discounted using the group's incremental borrowing
rate 526
Less: short-term leases recognized on a straight-line
basis as expense (210)
Lease liability recognized as at January 1, 2019 316
=========
In applying IFRS 16 for the first time, the group has used the following
practical expedients permitted by the standard:
-- the use of a single discount rate to a portfolio of leases with
reasonably similar characteristics;
-- accounting for operating leases with a remaining lease term of less than
12 months as at January 1, 2019, as short-term leases;
-- the use of hindsight in determining the lease term where the contract
contains options to extend or terminate the lease; and
-- excluding initial direct costs from the initial measurement of the
right-of-use asset.
The Group is applying IFRS 16's low-value and short-term exemptions.
The adoption of IFRS 16 has had no impact on the Group's net cash flows,
although a presentation change has been reflected whereby cash outflows
of GBP84 thousand are now presented as financing, instead of operating.
There is a decrease of GBP9 thousand in general and administrative costs
as depreciation of the right of use asset is less than the lease costs
and a GBP9 thousand increase in finance expense from the presentation of
a portion of lease costs as interest costs. There is no significant
impact on overall loss before tax and loss per share.
4. Segmental reporting
The Group's activities are covered by one operating and reporting
segment: Drug Development. There have been no changes to management's
assessment of the operating and reporting segment of the Group during
the period.
All non-current assets are based in the United Kingdom.
5. Financial Instruments
The Group's activities expose it to a variety of financial risks: market
risk (including foreign currency risk); cash flow and fair value
interest rate risk; and credit risk and liquidity risk. The condensed
consolidated interim financial statements do not include all financial
risk management information and disclosures required in the annual
financial statements, and they should be read in conjunction with the
Group's annual financial statements for the year ended December 31,
2018.
6. Estimates
The preparation of condensed consolidated interim financial statements
require management to make judgments, estimates and assumptions that
affect the application of accounting policies and the reported amounts
of assets and liabilities, income and expenses. Actual results may
differ from those estimates.
In preparing these condensed consolidated interim financial statements,
the significant judgments made by management in applying the Group's
accounting policies and the key sources of estimation uncertainty were
the same as those applied to the consolidated financial statements for
the year ended December 31, 2018. In addition the company carried out a
value in use impairment review.
Impairment of intangible assets, goodwill and non-financial assets
The Company notes that after the reduction in the share price since
December 31, 2018, at various points in the quarter the market value of
the Company was less than its net book value. The Company has carried
out an impairment review and determined that Company's value in use
exceeds the carrying value of the Company's assets and, consequently,
that no impairment is required.
7. Finance income and expense
Three months Three months
ended March ended March
31, 2019 31, 2018
------------ --------------
Finance income: GBP'000s GBP'000s
Interest received on cash balances 250 160
Fair value adjustment on derivative financial instruments
(note 11) 1,610 --
Total finance income 1,860 160
============ ============
Three months Three months
ended March ended March
31, 2019 31, 2018
------------ --------------
Finance expense: GBP'000s GBP'000s
Fair value adjustment on derivative financial instruments
(note 11) -- 8,977
Interest on discounted lease liability 9 --
Foreign exchange loss on translating foreign currency
denominated balances 783 1,332
Unwinding of discount factor related to the assumed
contingent arrangement
(note 12) 28 15
------------ ------------
Total finance expense 820 10,324
============ ============
8. Taxation
The tax credit for the three months ended March 31, 2019, amounts to
GBP1,313 thousand, and consists of the estimated research and
development tax credit receivable on qualifying expenditure incurred
during the three months ended March 31, 2019 for an amount of GBP1,316
thousand less a tax expense of GBP3 thousand related to the US
operations (three months ended March 31, 2018: GBP820 thousand tax
credit, comprising GBP923 thousand for research and development tax
credit, less GBP103 thousand expense for tax on US operations).
9. Loss per share calculation
The basic loss per share of 5.1p (March 31, 2018: 14.5p) for the three
months ended March 31, 2019 is calculated by dividing the loss for the
three months ended March 31, 2019 by the weighted average number of
ordinary shares in issue of 105,326,637 during the three months ended
March 31, 2019 (March 31, 2018: 105,017,400). Since the Group has
reported a net loss, diluted loss per ordinary share is equal to basic
loss per ordinary share.
Each ADS represents 8 shares of the Company, so the loss per ADS is any
period is equal to 8 times the loss per share.
10. Short term investments
Short term investments as at March 31, 2019, amounted to a total of
GBP35.3 million (December 31, 2018: GBP44.9 million) and consisted of
fixed term deposits, in both US dollars and pounds sterling.
11. Derivative financial instrument
Pursuant to the July 2016 placement the Company issued 31,115,926 units
to new and existing investors at the placing price of GBP1.4365 per unit,
each of which was comprised of one ordinary share and one warrant. The
warrant holders can subscribe for 0.4 of an ordinary share at a per
share exercise price of 120% of the placing price (GBP1.7238). The
warrant holders can opt for a cashless exercise of their warrants by
choosing to exchange the warrants held for a reduced number of warrants
exercisable at nil consideration. The reduced number of warrants is
calculated based on a formula considering the share price and the
exercise price of the shares. The warrants were therefore classified as
a derivative financial liability, since their exercise might result in a
variable number of shares to be issued. The warrants expire on May 2,
2022.
At December 31, 2018, and March 31, 2019, warrants over 12,446,370
shares were in effect.
At March 31, At December
2019 31, 2018
---------------- ----------------
Shares available to be issued under
warrants 12,401,262 12,401,262
Exercise price GBP 1.7238 GBP 1.7238
Risk-free interest rate 0.63% 0.76%
Time to expiry 3.09 years 3.34 years
Annualized volatility 60.69% 60.72%
Dividend rate 0.00% 0.00%
Dilution discount 7.47% 5.66%
As at March 31, 2019, the Group updated the underlying assumptions and
calculated a fair value of these warrants, using the Black-Scholes
pricing model (including level 3 assumptions), amounting to GBP0.9
million.
The variance for the three months ended March 31, 2019, was GBP1.6
million (three months ended March 31, 2018: GBP9.0 million) and is
recorded as finance income (March 31, 2018, recorded in finance expense)
in the Consolidated Statement of Comprehensive Income.
Derivative Derivative
financial financial
instrument instrument
----------- -------------
2019 2018
----------- -------------
GBP'000s GBP'000s
At January 1, 2,492 1,273
Fair value adjustments recognized in profit or
loss (1,610) 8,977
---------- -----------
At March 31, 882 10,250
========== ===========
For the amount recognized as at March 31, 2019, the effect if volatility
were to deviate up or down is presented in the following table.
Volatility
(up / down
10 % pts)
-----------
GBP'000s
Variable up 1,323
Base case, reported fair value 882
Variable down 500
12. Assumed contingent obligation related to the business combination
The value of the assumed contingent obligation as of March 31, 2019,
amounted to GBP1,018 thousand (December 31, 2018: GBP996 thousand). The
increase in value of the assumed contingent obligation during the three
months ended March 31, 2019, amounted to GBP22 thousand (three months
ended March 31, 2018: GBP15 thousand) and the unwinding of the discount
was recorded in finance expense. Periodic re-measurement is triggered by
changes in the probability of success. The discount percentage applied
is 12%. In 2018 and the three months ended March 31, 2019, there were
no events that triggered remeasurement.
2019 2018
-------- ----------
GBP'000s GBP'000s
At January 1, 996 875
Impact of changes in foreign exchange rates (6) (9)
Unwinding of discount factor 28 24
------- ------
At March 31, 1,018 890
======= ======
There is no material difference between the fair value and carrying
value of the financial liability.
For the amount recognized as at March 31, 2019, of GBP1,018 thousand,
the effect if underlying assumptions were to deviate up or down is
presented in the following table (assuming the probability of success
does not change):
Discount
rate Revenue
(up / down (up / down
1 % pt) 10 % pts)
GBP'000s GBP'000s
Variable up 978 1,047
Base case, reported fair value 1,018 1,018
Variable down 1,061 988
13. Share option scheme
During the three months ended March 31, 2019 the Company granted no
share options and no Restricted Stock Units ("RSUs") (three months ended
March 31, 2018, the Company granted 2,090,847 share options, and 273,390
RSUs).
The movement in the number of the Company's share options is set out
below:
Weighted Weighted
average average
exercise exercise
price 2019 price 2018
--------- --------- --------- -----------
GBP GBP
Outstanding at
January 1 1.53 8,752,114 1.54 7,527,457
Granted during the
period -- -- 1.46 2,090,847
---------
Outstanding options
at March 31 1.53 8,752,114 1.52 9,618,304
========= =========
The movement in the number of the Company's RSUs is set out below:
2019 2018
------- -----------
Outstanding at January 1 862,473 1,052,236
Granted during the period -- 273,390
------- ---------
Outstanding RSUs at March 31 862,473 1,325,626
======= =========
The share--based payment expense for the three months ended March 31,
2019, was GBP620 thousand (three months ended March 31, 2018: GBP1,019
thousand).
The remuneration committee has authorized the issue of 3,903,050 options
over ordinary shares and 740,496 RSUs to be issued to employees and one
director in April 2019.
14. Related party transactions
Dr David Ebsworth, Chairman of the Company, purchased 87,600 ordinary
shares for GBP50 thousand from the market in the period.
Piers Morgan, Chief Financial Officer of the Company, purchased 54,613
ordinary shares for GBP33 thousand from the market in the period.
At December 31, 2018, there was a receivable of GBP126 thousand (2017:
nil) due from one director and two key management personnel relating to
tax due on RSUs that vested in the year ended December 31, 2018. Of this,
GBP93 thousand was repaid with interest in the quarter and GBP33
thousand relating to the Company's National Insurance obligation was
settled by the Company.
In the period a director provided consultancy services for GBP11
thousand.
Convenience translation
The Company maintains its books and records in pounds sterling and
prepares its financial statements in accordance with IFRS, as issued by
the IASB. It reports its results in pounds sterling. For the convenience
of the reader the Company has translated pound sterling amounts in the
tables below as of March 31, 2019, and for the three months ended March
31, 2019, into US dollars at the noon buying rate of the Federal Reserve
Bank of New York on March 29, 2019, which was GBP1.00 to $1.3032. 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 of that or any other date.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION AS AT
MARCH 31, 2019 AND DECEMBER 31, 2018 (UNAUDITED)
As of As of As of
March 31, March 31, December 31,
2019 2019 2018
---------- ---------- ---------------
GBP'000s $'000s GBP'000s
ASSETS
Non-current assets:
Goodwill 441 576 441
Intangible assets 2,171 2,829 2,134
Property, plant and equipment 270 352 21
Total non-current assets 2,882 3,757 2,596
--------- --------- ------------
Current assets:
Prepayments and other
receivables 2,476 3,227 2,463
Current tax receivable 5,808 7,569 4,499
Short term investments 35,309 46,015 44,919
Cash and cash equivalents 18,726 24,404 19,784
Total current assets 62,319 81,215 71,665
--------- --------- ------------
Total assets 65,201 84,972 74,261
========= ========= ============
EQUITY AND LIABILITIES
Capital and reserves
attributable to equity
holders:
Share capital 5,266 6,863 5,266
Share premium 118,862 154,901 118,862
Share-based payment reserve 8,543 11,133 7,923
Accumulated loss (74,556) (97,161) (69,117)
--------- --------- ------------
Total equity 58,115 75,736 62,934
--------- --------- ------------
Current liabilities:
Derivative financial
instrument 882 1,149 2,492
Finance lease liabilities 241 314 --
Trade and other payables 4,850 6,322 7,733
Total current liabilities 5,973 7,785 10,225
--------- --------- ------------
Non-current liabilities:
Assumed contingent obligation 1,018 1,327 996
Deferred income 95 124 106
Total non-current liabilities 1,113 1,451 1,102
--------- --------- ------------
Total equity and liabilities 65,201 84,972 74,261
========= ========= ============
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME FOR
THE THREE MONTHS ENDED MARCH 31, 2019 AND MARCH 31, 2018 (UNAUDITED)
Three months Three months Three months
ended March ended March ended March
31, 2019 31, 2019 31, 2018
-------------- -------------- --------------
GBP'000s $'000s GBP'000s
Research and development costs (5,928) (7,726) (4,421)
General and administrative costs (1,831) (2,386) (1,458)
--------- ---------- ----------
Operating loss (7,759) (10,112) (5,879)
Finance income 1,860 2,424 160
Finance expense (820) (1,069) (10,324)
--------- ---------- ----------
Loss before taxation (6,719) (8,757) (16,043)
Taxation -- credit 1,313 1,711 820
--------- --- ---------- ----------
Loss for the year (5,406) (7,046) (15,223)
Other comprehensive loss:
Items that might be subsequently reclassified to profit
or loss
-------------- --------------
Exchange differences on translating foreign operations (13) (17) (27)
--------- ---------- ----------
Total comprehensive loss attributable to owners of
the Company (5,419) (7,063) (15,250)
========= ========== ==========
Loss per ordinary share -- basic and diluted (pence) (5.1) (6.7) (14.5)
(END) Dow Jones Newswires
May 07, 2019 02:01 ET (06:01 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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