TIDMSALV
RNS Number : 8244S
SalvaRx Group plc
28 June 2018
SalvaRx Group PLC
Final Results
Chairman's Statement
I am pleased to present the audited final results for SalvaRx
Group PLC ("SalvaRx", "the Company" or "the Group"), for the year
ended 31 December 2017.
Over the past year, the team has executed upon its strategy to
grow a pipeline of novel treatments for cancer and now has ten
products in development including one which is in human trials.
SalvaRx has continued to deliver on its mission of helping
patients with cancer by advancing its products into the clinic and
acquiring exciting additional products in the immunotherapy sector.
The Group has reviewed hundreds of opportunities and has now
invested in five exciting platform companies where it is actively
helping to drive strategy and execution.
The loss for the year ended 31 December 2017 was GBP2,234,000
(2016: GBP2,445,000). This reflects growth in the pipeline and
continued investment in research and development of GBP1,185,000
(2016: GBP693,000).
Since February of 2017, and including the loan announced on 26
June 2018, the SalvaRx Group companies have raised US$6m in various
debt instruments, of which $4m has come from Greg Bailey and
myself. This additional funding will help us to support our current
business. It is our intention to provide further financial support
if required.
The investor community continues to be enthusiastic about
advances being made in biotechnology companies. Value is being
generated by careful development of innovative products. The
SalvaRx team has assembled a broad pipeline of potential first in
class products from top notch scientists/Universities. The early
human data with Intensity's treatment is quite encouraging. I look
forward to seeing the progress over the next year as more is
learned about our products.
Jim Mellon
Non-executive Chairman
27 June 2018
SalvaRx Group plc
Ian Walters (Chief Executive) Tel: +1 203 441 5451
Northland Capital Partners Limited Tel: +44 (0) 20 3861
Nominated Adviser and Broker 6625
Matthew Johnson / Edward Hutton (Corporate
Finance)
John Howes (Corporate Broking)
Peterhouse Corporate Finance Limited Tel: +44 (0) 20 7469
Joint Broker 0932
Lucy Williams / Duncan Vasey
A copy of the Annual Report and Accounts will be available to
download from the Company's website www.salvarx.io today. Hard
copies of the Annual Report and Accounts will be posted to
shareholders who have requested them on 29 June 2018.
CEO's Strategic Report
In its third year of operations, SalvaRx has continued to
execute on its strategy to grow its pipeline of products and help
develop innovative medicines for the treatment of cancer. We have
now formed five investments, and have built a pipeline of ten
compounds. Intensity Therapeutics, in which we have an 8.5%
interest, has its first programme in the clinic and iOx is poised
to enter the clinic soon with its lead compound. These represent
major milestones that de-risk the programs. A huge amount of effort
by the various teams has enabled us to progress our projects to
this point.
iOx Therapeutics Limited (56.95% subsidiary undertaking)
iOx Therapeutics Limited ("iOx") has been progressing its two
products through preclinical development and manufacturing. IMM60,
which is the lead program, is preparing to enter the clinic soon.
To enable this initiation of human testing, iOx needs to satisfy
the regulators that it can manufacture the product to specification
and has the ability to qualify the batches produced to ensure
consistency across each dose. Much work has been done to inspect
the contract manufacturing facilities that make the active
ingredient and the drug product. The team has developed the
analytical methods to test the batches of drug that are coming off
the production line and it has successfully scaled the
manufacturing process. The iOx team believes all the required
information will be in place shortly to allow for a regulatory
submission this year. This also includes the animal safety study
agreed upon by the Medicines and Health Regulatory Agency to enable
determination of a safe dose for humans.
In parallel, the PRECIOUS team, a consortium of academic experts
from five leading European universities, continues to make progress
in the development of our second product, IMM65. IMM65 starts with
the above mentioned active ingredient in IMM60 which gets
co-formulated with a tumor vaccine (NY-ESO). We have established a
process to manufacture these particles for human use and the team
is actively managing the workflow to also enable a clinical trial
to start next year.
iOx continues to prosecute and progress its patent applications
in major markets. Additional patents covering liposomal formulation
of its iNKT agonist (US patent 15/253,307, EU patent 2654779) have
been issued. After the year end, iOx announced the placement of
US$950,000 in the form of a convertible loan in order to fund the
near term R&D activities. iOx is actively seeking partners and
license opportunities.
Intensity Therapeutics Inc. ($2million investment, representing
8.5% equity)
Intensity Therapeutics Inc. ("Intensity") has been working
diligently to find suitable patients in order to test the safety of
its lead product, INT230-6 in humans with refractory solid tumors.
Intensity announced on 28 February 2018 that it had demonstrated
the safety of INT230-6 in the first six patients with ovarian, head
and neck, skin, and thyroid cancers who have received INT230-6
injected into tumors which are superficially palpable. This has
enabled the study to recruit and treat patients who can receive
injections to deep tumors via image guidance. Indeed, the first
patient with cholangiocarcinoma has been treated. The study is
designed to further examine the safety and utility in a variety of
tumor types.
Nekonal Oncology Ltd (EUR300K investment representing 31.07%
equity and a EUR300K option to invest in another subsidiary of the
parent company)
Nekonal Oncology Ltd ("Nekonal Oncology") was formed last year
based on the work of a former Harvard professor Nalan Utku, MD. The
team has been making the prototype drugs (monoclonal antibodies)
and testing their potency in various systems. Its goal is to refine
the lead programs in order to prioritize the testing going
forward.
Rift Biotherapeutics Inc. ($1.44million investment for approx.
37% equity)
Our initial investment in Rift Biotherapeutics Inc. ("Rift") was
$1.09 million for an interest of approximately 30% in Rift. This
enabled Rift to begin testing its lead drug alone and in
combination with other standard of care drugs in animal models. The
preliminary data was encouraging and the Group advanced another
$350K in December 2017 to expand upon this work. The scientists at
Rift continue to build a case on how their lead product can
reprogram the tumor microenvironment to enable a more productive
inflammatory response against the cancer. They have also begun to
test their second compound. The Group has the option to invest an
additional $1.15 million at the same valuation and to acquire all
the outstanding shares of Rift for new shares in the Group on the
same basis
Saugatuck Therapeutics Ltd ($300K initial investment, subsidiary
undertaking)
Saugatuck Therapeutics Ltd ("Saugatuck") was formed near the end
of the year as a three way collaboration between Yale University,
SalvaRx Limited and The Sunnybrook Research Institute in Toronto.
The technology platform allows Saugatuck to co-formulate two drugs
into a single package (nanolipogel). This technology allows drugs
with very different physical and chemical properties to be
transported to, and released, at the disease site in a coordinated
manner. Initial work to start formulating a PD1 binding aptamer is
underway.
Group Structure
On 17 March 2017, the Company announced the Directors decision
to streamline the Group structure such that all investments would
be held, and a new loan facility would be issued, by SalvaRx
Limited, the Group's wholly owned BVI subsidiary.
Financing
At 31 December 2017, the Group had cash and cash equivalent of
approximately GBP0.6 million. Subsequently, on 8 March 2018, IOX
Therapeutics raised $1m through the issue of a convertible loan and
on 26 June 2018 it was announced that a $1m loan was secured by the
Company. The group continues to enjoy the support of its principal
shareholders and further details relating to going concern are set
out in the Directors Report.
Outlook
The main objective when we started this Company was to identify
drugs/products that had interesting science behind them and that
could benefit from our drug development and commercialization
expertise. We have now been successful in sourcing a wide range of
products from around the globe. Each has specific needs and
challenges that our extended team has been focused on resolving.
Not everything will go as planned, but the team has many years of
experience in overcoming challenges, and finding creative solutions
to push the programs forward.
The real reward is trying to help give hope to cancer patients
for whom the available drugs have failed and are in need of new
options. I am reminded of how challenging this is as one of our
investigators writes to me about a woman in her 30s with no other
options who is eager to get into one of our trials. The investor
community is also optimistic about this sector with record amounts
of venture money flowing into startups this past year. In fact, in
February 2018, BMS recorded the largest upfront payment for a
license in history. They paid US$3.6 billion for 35% of the profits
on Nektar's immunotherapy after seeing data on approximately 40
patients.
At the SalvaRx corporate level, we continue to identify
potential investments or acquisitions. We expect to grow further by
acquisition, investment or licensing arrangements as we identify
novel cancer immunotherapies. Not all of our projects will
progress, as we are continually prioritizing those with the highest
probability of success.
Dr lan Walters
Chief Executive Officer
27 June 2018
Directors' Report
Introduction
The Directors present their report and financial statements of
SalvaRx Group plc ('the Group') for the year ended 31 December
2017.
Principal activity
The Group's principal activity is that of drug discovery and
development, focused on immune-oncology.
Business and financial review and future developments
The plans for the future are set out in the Chairman's Statement
and CEO's Strategic Report.
Results and dividends
The Group's loss for the year after taxation was GBP2.23 million
(2016: loss of GBP2.45 million). The Directors do not recommend the
payment of a dividend for the year.
Directors
The Directors of the Group that served during the year and
subsequently were as follows:
Jim Mellon, Non-Executive Chairman
Dr Ian Walters, Chief Executive Officer
Kam Shah, Chief Financial Officer
Dr Greg Bailey, Non-Executive Director
Richard Armstrong, Non-Executive Director
Colin Weinberg, Non-Executive Director
Biographical details of serving Directors can be found in the
Board of Directors section.
Annual General Meeting and re-election of Directors
The date of the Annual General Meeting will be announced in due
course.
Directors' Interests
The table below sets out the Directors interests in the
Company's Ordinary Shares, including their connected persons,
together with details of options held by the directors over New
Ordinary Shares of the Company:
Director Number of Ordinary shares Percentage of issued share capital Number of Options Exercise Price
J Mellon 13,320,291 36.53% 86,230 23.2p
G Bailey 13,320,291 36.53% 86,230 23.2p
I Walters - - 428,786 35.5p
K Shah - - 364,666 35.5p
R Armstrong 64,635 0.18% 86,230 23.2p
R Armstrong 91,166 35.5p
C Weinberg 43,103 0.12% 86,230 23.2p
C Weinberg 91,166 35.5p
_________ _________
26,748,320 1,320,704
_________ _________
Note: options with an exercise price of 23.2p are exercisable at
any time until 16 February 2021. Options with an exercise price of
35.5p are exercisable in three equal annual tranches from 22 March
2017, except such options granted to Richard Armstrong and Colin
Weinberg which are exercisable in event that they step down from
the Board in due course on the appointment of new non-executive
directors.
In addition to the above, J Mellon and G Bailey hold options
over shares in SalvaRx Limited relating to warrants issued on the
non-convertible loan notes in the year. Details of the terms of
these loans are included in note 19.
I Walters and K Shan both hold 389 and 130 options respectively
over shares in iOx Therapuetics Limited, a subsidiary in which the
Group holds 56.95% equity.
The interests of Jim Mellon in the table above include Ordinary
Shares in the Company held by Port Erin Biopharma Investments
Limited and Galloway Limited. Jim Mellon holds controlling
interests in these companies.
Directors' insurance and indemnity provisions
Subject to the conditions set out in the Isle of Man Companies
Act 2006 and the Company's Articles of Association, the Company has
arranged appropriate Directors' insurance to indemnify the
Directors against liability in respect of proceedings brought by
third parties. The annual cost of the cover is not material to the
Group.
Significant shareholders
Other than the Directors' interests shown above, the Company had
been notified that the following is a holder of 3% or more of the
Company's issued Ordinary Share capital:
Number of Shares %
Yongxiong Zheny 2,318,676 6.35
Notes:
Except for the holding of Ordinary Shares listed above, the
Directors are not aware of any person holding 3% or more of the
issued share capital at the date of this report.
Share capital
Details of the issued share capital, together with details of
the movement in issued share capital during the year, are shown in
note 22 to the financial statements.
Principal risks and uncertainties
The principal risks faced by the Company and the actions taken
to mitigate them, are shown in the table below:
Risk/Description Principal mitigation
Intellectual property:
In common with other companies The Company and its partners
engaged in pharmaceutical development, actively manage all intellectual
the Company faces the risk property (IP) rights, engaging
that intellectual property with specialists to apply for
rights necessary to exploit and defend IP rights in appropriate
its research and development territories.
efforts may not be adequately
secured or defended. The Group's
intellectual property may also
become obsolete, preventing
commercial exploitation.
--------------------------------------
Risk/Description Principal mitigation
Research and development:
The Company may not generate The lead product candidate has
further attractive drug candidates successfully completed a comprehensive
and candidates already in development preclinical development programme
may fail clinical trials because and the safety and efficacy profile
of lack of efficacy, unacceptable is well understood. The clinical
side effects, or insurmountable trials will be designed based
challenges in conducting studies on the data from the development
adequate to support regulatory programme completed to date.
approvals. Practical issues,
such as inability to devise
acceptable formulations for
products or inability to manufacture
products at acceptable cost,
may also lead to failure of
candidates in development.
-----------------------------------------
Regulatory:
Drug development is a highly The Company's and its partners'
regulated activity governed drug development teams include
by different regulatory authorities specialists in regulatory affairs
in different jurisdictions. who consult with other experts
It can be difficult to predict to ensure that internal control
the exact requirements of different processes and clinical trial
regulatory bodies. Decisions design meet current regulatory
by regulators may lead to delays requirements. The Company also
in development and approval engages directly with regulatory
of drugs or lack of marketing authorities when appropriate
authorisations in some or all
territories.
-----------------------------------------
Financial:
The successful development To date the Group has raised
of the Company's assets requires the capital necessary to fund
financial investment which its development through a mixture
can come from revenues, commercial of debt and equity funding. The
partners, or investors. Failure Board continuously monitor the
to generate additional funding ongoing funding requirement and
from these sources may compromise take action as appropriate.
the Company's ability to execute
its business plans or to continue The Group also operates robust
in business. controls over expenditures including
budgeting and authorisation of
individual expenditures.
-----------------------------------------
Commercial and economic:
The Company may be unable to The Company consults with commercial,
effectively commercialise or clinical, and scientific experts
license its products to partners to assess the payer and prescriber
or may not be able to execute environment and the potential
licensing deals that provide impact of competing products
significant revenues. Development or changes in the economic landscape
of alternative technologies pertaining to hospital infections.
or products may undermine the The management actively monitors
Company's capacity to generate performance of key competitors
revenue flowing from commercialisation in terms of pricing, market share,
of its assets. If the Company's and prescribing behaviour.
drugs are commercialised, they
may not generate significant
revenues if their use and sale
is restricted by regulators
or by failure of healthcare
payors to provide adequate
reimbursement of drug costs.
-----------------------------------------
Operational:
The Company may not be able The Company's recruitment processes
to recruit and retain appropriately are tailored to identify and
qualified staff. Facilities attract the best candidates for
and other resources may become specific roles. The Company aims
unavailable. to provide competitive rewards
and incentives to staff and directors,
and informally benchmarks the
level of benefits provided to
its people against similar companies.
-----------------------------------------
Key Performance Indicators
At this stage, the success of the Group is dependent upon the
success of future clinical trials. When the outcomes of these
trials are known, if and when the Company moves into production,
financial, operational, health and safety and environmental KPIs
will become relevant and be measured and reported accordingly.
Political donations
There were no political donations made by the Group in the
current or prior year.
Charitable donations
There were no charitable donations made by the Group in the
current or prior year.
Going concern
At 31 December 2017, the Group had cash and cash equivalent of
approximately GBP0.6 million. Subsequently, on 8 March 2018, IOX
Therapeutics raised $1m through the issue of a convertible loan and
on 26 June 2018 it was announced that a $1m loan was secured by the
Company.
The Board has prepared cash flow forecasts for the period
through to June 2019. The forecasts indicate that further funding
will be required over and above existing resources and this
includes repayment of the $1m loan issued on 26 June 2018 which is
repayable within one year. However, the Directors have prepared
these financial statements on the basis that Jim Mellon and Dr Greg
Bailey will continue to provide financial support necessary for the
group to meet its liabilities as they fall due.
The Group continues to incur losses and transition to
profitability is dependent upon achieving a level of revenues
adequate to support the Group's cost structure and until doing so,
intends to fund future operations through additional debt or equity
offerings. Because additional financing is not committed at the
date of approval of these financial statements, these circumstances
represent a material uncertainty as to the Group's ability to
continue as a going concern. Should the Group be unable to obtain
further finance such that the going concern basis of preparation
were no longer appropriate, adjustments would be required including
to reduce balance sheet values of assets to their recoverable
amounts, to provide for further liabilities that might arise and to
reclassify non-current assets as current assets.
Payment of suppliers
It is the Group's policy that payments to suppliers are made in
accordance with terms and conditions agreed between the Group and
its suppliers. The average payment period for creditors for the
year was 45 days (2016: 40 days).
Post balance sheet events
Events after the balance sheet date have been disclosed in note
26 to the financial statements.
Statement as to disclosure of information to the auditor
Each Director in office at the date of this report has
confirmed, as far as he is aware, that there is no relevant audit
information of which the auditor is unaware. Each such Director has
confirmed that he has taken all the steps that he ought to have
taken as a Director in order to make himself aware of any relevant
audit information and to establish that the auditor is aware of
that information.
Auditor
A resolution to reappoint RSM UK Audit LLP as auditor, at a fee
to be agreed, will be proposed by the Board.
The Directors' Report was approved by the Board of Directors and
signed on its behalf by:
Kam Shah
Chief Financial Officer
27 June 2018
Board of Directors
Jim Mellon, Non-Executive Chairman
Jim Mellon is an investor with interests in several industries.
After leaving Oxford University, where he studied PPE, he worked in
Asia and the United States in two fund management companies, GT and
Thornton, before establishing his own business in 1991. This now
has two components: a listed fund management company, Charlemagne
Capital Limited and an Asian investment group, Regent Pacific Group
Limited. In addition, Jim is a controlling shareholder and a
director of Manx Financial Group, an Isle of Man based bank and a
controlling shareholder of Webis Holdings plc. He is also a
co-founder of Uramin and Red Dragon Resources, both mining groups.
Burnbrae, his private company, is a substantial landlord in Germany
and in the Isle of Man, and it owns outright the hotel chain,
Sleepwell Hotels Limited. Jim is the co-chairman of FastForward
Innovations Limited and a director of Portage Biotech Inc.. His
book 'Cracking the Code', which was published in 2012, focused on
investment opportunities in the life sciences sector. Jim is an
honorary fellow of Oriel College, Oxford University.
Dr Ian Walters, Chief Executive Officer
Ian Walters, M.D., M.B.A., is the Entrepreneur in Residence at
Mediqventures and is part-time CMO of Intensity Therapeutics, Inc.
Over his 19 year career, he has demonstrated both leadership and
expertise in drug development, including the advancement of
multiple cancer compounds from research stages through approval.
Ian specialises in the evaluation, prioritisation, and the
innovative development of new therapies for the treatment of severe
diseases. He has worked at PDL BioPharma, Inc., Millenium
Pharmaceuticals, Inc., and Sorrento Therapeutics, Inc., leading
corporate development, translational medicine, clinical development
and medical affairs. Ian spent seven years at Bristol-Myers Squibb
between 2007 and 2014, where he managed physicians overseeing the
international development of more than eight oncology compounds
(including Nivolimab (anti-PD-1), Ipilimumab (anti-CTLA-4),
brivanib (anti VEGF/FGF), anti-IGF/IR, VEGFR2 biologic, Elotuzimab
(antiCS1), as well as biomarker and companion diagnostic work. He
was a core member of Bristol-Myers Squibb's Strategic Transactions
Group evaluating and executing licensing agreements, mergers and
acquisitions, clinical collaborations, and the company's
immuno-oncology strategy. Before entering the private sector, Ian
was a lead investigator at the Rockefeller University and initiated
advanced immunology research to understand the mechanism of action
of several compounds. Ian received his MD from the Albert Einstein
College of Medicine and an MBA from the Wharton School of The
University of Pennsylvania.
Kam Shah CA, CPA (Canada), CPA (US), CGMA(US), Chief Financial
Officer
Kam Shah is a senior finance executive with over 25 years of
financial and management experience across a range of industries
and companies with significant operating scale and complexity. Kam
is a Certified Public Accountant and Chartered Global Management
Accountant of the American Institute of CPAs and a Chartered
Professional Accountant of the Canadian Institute of CPAs. He has
experience in all aspects of corporate finance, including audits,
SEC/OSC reporting, forecasting, and business plan development. Over
the past 15 years, Kam has served as the Chief Financial Officer
and Corporate Secretary of Portage Biotech, Inc., a publicly listed
group of companies engaged in biotechnology and oil and gas
exploration.
Dr Greg Bailey, Non-Executive Director
Greg Bailey, M.D., is chairman of Portage Biotech, Inc. and was
previously managing partner of Palantir Group, Inc., a merchant
bank specialising in biotech and intellectual property. He has over
15 years' experience in investment banking and has founded several
companies. Along with comprehensive experience in healthcare,
finance and medicine, Greg brings to the Board an extensive
involvement in corporate governance. He has served on multiple
public company boards of directors, was a practicing physician for
ten years and holds a M.D. degree from the University of Western
Ontario.
Richard Armstrong, Non-Executive Director
Richard Armstrong is a former equity analyst and corporate
broker. He has extensive experience in reconstructing and raising
capital for turnaround situations, especially in the quoted
microcap sector, for example Weatherly International plc, K P
Renewables plc (now IGas Energy plc), Future Internet Technologies
plc (now Artilium plc) and Mobilefuture plc. In most cases, he has
joined the board of these companies and has played a major role in
helping them to acquire or establish operating businesses.
Colin Weinberg, Non-Executive Director
Colin Weinberg is a former stockbroker with some 40 years'
experience with a range of firms including Durlacher plc and Walker
Crips Weddle Beck plc. He is a former director of Peckham Building
Society and is currently a director of Associated British
Engineering plc, a listed company.
Corporate Governance Statement
The Directors intend to comply with the Corporate Governance
Code published by the Quoted Companies Alliance in 2018, to the
extent that they consider it appropriate and having regard to the
Company's size, board structure, stage of development and resources
with particular emphasis on management effectiveness and
independence and transparency.
The Directors hold regular board meetings which are responsible
for formulating, reviewing and approving the Company's strategy,
budget and major items of capital expenditure. An audit committee,
a remuneration committee and a nomination committee have been
established with formally delegated rules and responsibilities.
Each of these committees meets as and when appropriate.
The Audit Committee comprises Richard Armstrong (Chairman), Jim
Mellon and Dr Greg Bailey
The Remuneration Committee comprises Jim Mellon (Chairman),
Richard Armstrong, Dr Greg Bailey and Colin Weinberg.
The Nomination Committee comprises Colin Weinberg (Chairman),
Jim Mellon and Richard Armstrong.
Jim Mellon
Non-executive Chairman
27 June 2018
Statement of Directors' Responsibilities
The directors are responsible for preparing the Directors'
Report and the financial statements in accordance with applicable
law and regulations.
Isle of Man company law requires the directors to prepare group
financial statements in accordance with generally accepted
accounting principles. The directors are required by the AIM Rules
of the London Stock Exchange to prepare group financial statements
in accordance with International Financial Reporting Standards
("IFRS") as adopted by the European Union ("EU").
The financial statements of the group are required by law to
give a true and fair view of the state of the group's affairs at
the end of the financial period and of the profit or loss of the
group for that period and are required by IFRS as adopted by the EU
to present fairly the financial position of the group and the
financial performance of the group.
In preparing the financial statements, the directors should:
-- select suitable accounting policies and then apply them consistently;
-- make judgements and accounting estimates that are reasonable and prudent;
-- state whether they have been prepared in accordance with IFRS adopted by the EU; and
-- prepare the financial statements on the going concern basis
unless it is inappropriate to presume that the group will continue
in business.
The directors are responsible for keeping reliable accounting
records which correctly explain the group's transactions and enable
them to determine, with reasonable accuracy, the financial position
of the group at any time and allow financial statements to be
prepared. They are also responsible for safeguarding the assets of
the group and hence for taking reasonable steps for the prevention
and detection of fraud and other irregularities.
The directors are responsible for the maintenance and integrity
of the corporate and financial information included on the SalvaRx
Group PLC website. Legislation in Isle of Man governing the
preparation and dissemination of financial statements may differ
from legislation in other jurisdictions.
Independent Auditor's Report to the Members of SalvaRx Group
plc
Opinion
We have audited the financial statements of SalvaRx Group plc
and its subsidiaries (the 'group') for the year ended 31 December
2017 which comprise the consolidated statement of profit and loss
and other comprehensive income, the consolidated balance sheet, the
consolidated cash flow statement, the consolidated statement of
changes of equity and notes to the financial statements, including
a summary of significant accounting policies. The financial
reporting framework that has been applied in their preparation is
applicable law and International Financial Reporting Standards
(IFRSs) as adopted by the European Union.
In our opinion the financial statements:
-- give a true and fair view of the state of the group's affairs
as at 31 December 2017 and of the group's loss for the year then
ended;
-- have been properly prepared in accordance with IFRSs as adopted by the European Union;
-- have been properly prepared in accordance with the
requirements of the Isle of Man Companies Act 2006.
Basis for opinion
We conducted our audit in accordance with International
Standards on Auditing (UK) (ISAs (UK)) and applicable law. Our
responsibilities under those standards are further described in the
Auditor's responsibilities for the audit of the financial
statements section of our report. We are independent of the group
in accordance with the ethical requirements that are relevant to
our audit of the financial statements in the UK, including the
FRC's Ethical Standard as applied to SME listed entities and we
have fulfilled our other ethical responsibilities in accordance
with these requirements. We believe that the audit evidence we have
obtained is sufficient and appropriate to provide a basis for our
opinion.
Material uncertainty related to going concern
We draw attention to note 3 in the financial statements which
indicates that the group's ability to continue as a going concern
is dependent upon the continued financial support of Mr J Mellon
and Dr G Bailey who are the majority shareholders and Directors of
the Group. Whilst Mr J Mellon and Dr G Bailey have indicated that
they intend to continue to provide that support, the group does not
have committed funding sufficient to cover the cash outflow
anticipated by latest management forecasts. As stated in note 3,
these events or conditions, along with the other matters set forth
in note 3, indicate that a material uncertainty exists that may
cast significant doubt on the Group's ability to continue as a
going concern. Our opinion is not modified in respect of this
matter.
Key audit matters
Key audit matters are those matters that, in our professional
judgment, were of most significance in our audit of the financial
statements of the current period and include the most significant
assessed risks of material misstatement (whether or not due to
fraud) we identified, including those which had the greatest effect
on the overall audit strategy, the allocation of resources in the
audit and directing the efforts of the engagement team. These
matters were addressed in the context of our audit of the financial
statements as a whole, and in forming our opinion thereon, and we
do not provide a separate opinion on these matters. In addition to
the matter described in the Material uncertainty related to going
concern section we have determined the matter described below to be
the key audit matter to be communicated in our report.
Accounting for the loan note instrument constituted on 2 March
2017
As detailed in note 19, on 2 March 2017 the group announced the
constitution and offer of a US$5 million loan note of which
US$3,940,000 was subscribed by 31 December 2017 (the "Instrument").
The terms of the loan note are set out in detail in note 19,
however a key accounting matter arises as the Instrument comprises
the loan and also a warrant to subscribe for shares in SalvaRx
Limited.
IFRS requires management to determine separate fair values for
the loan and for the warrant and this is subject to both judgement
and estimation both at inception and at the 31 December 2017 as
explained in note 4. At 31 December 2017, the loan balance held at
amortised cost is GBP2,603,000 and the warrant liability is
GBP361,000. Due to the significance of these liabilities, and the
judgements and estimates involved, we considered this to be one of
the most significant risks of material misstatement.
Management provided us with an accounting paper detailing their
proposed treatment for the Instrument. We reviewed the paper in
conjunction with a valuation specialist and considered the
appropriateness of the proposed accounting judgements, challenging
management where relevant.
Management also provided us with their calculations of the fair
values attributable to the loan and to the warrant on subscription.
We subjected these calculations to arithmetical checking. We also
assessed the estimates within these calculations and consulted with
valuation specialists on the key inputs where necessary.
At 31 December 2017 we:
-- Checked the calculation of amortised cost for the loan
element of the Instrument, with reference to the imputed rate of
interest calculated at subscription,
-- Considered whether there was any evidence to suggest a
material change in the valuation of the warrant liability, and
-- Checked the treatment of foreign exchange differences arising on the Instrument.
In light of our work, we also considered the adequacy of
disclosures relating to the instrument set out in notes 4 and 19 to
the financial statements.
We aggregated the factual differences that our work identified
and considered these within the context of our overall audit.
Our application of materiality
When establishing our overall audit strategy, we set certain
thresholds which help us to determine the nature, timing and extent
of our audit procedures and to evaluate the effects of
misstatements, both individually and on the financial statements as
a whole. During planning we determined a magnitude of uncorrected
misstatements that we judge would be material for the financial
statements as a whole (FSM). During planning FSM was calculated as
GBP153,000, which was not changed during the course of our audit.
We agreed with the Audit Committee that we would report to them all
unadjusted differences in excess of GBP5,000 as well as differences
below those thresholds that, in our view, warranted reporting on
qualitative grounds.
An overview of the scope of our audit
Our audit approach covered 100% of group loss and total group
assets and liabilities. It was performed to the materiality levels
set out above.
Other information
The directors are responsible for the other information. The
other information comprises the information included in the annual
report, other than the financial statements and our auditor's
report thereon. Our opinion on the financial statements does not
cover the other information and, except to the extent otherwise
explicitly stated in our report, we do not express any form of
assurance conclusion thereon.
In connection with our audit of the financial statements, our
responsibility is to read the other information and, in doing so,
consider whether the other information is materially inconsistent
with the financial statements or our knowledge obtained in the
audit or otherwise appears to be materially misstated. If we
identify such material inconsistencies or apparent material
misstatements, we are required to determine whether there is a
material misstatement in the financial statements or a material
misstatement of the other information. If, based on the work we
have performed, we conclude that there is a material misstatement
of this other information, we are required to report that fact. We
have nothing to report in this regard.
Responsibilities of directors
As explained more fully in the directors' responsibilities
statement set out on page 14, the directors are responsible for the
preparation of the financial statements and for being satisfied
that they give a true and fair view, and for such internal control
as the directors determine is necessary to enable the preparation
of financial statements that are free from material misstatement,
whether due to fraud or error.
In preparing the financial statements, the directors are
responsible for assessing the group's ability to continue as a
going concern, disclosing, as applicable, matters related to going
concern and using the going concern basis of accounting unless the
directors either intend to liquidate the group or to cease
operations, or have no realistic alternative but to do so.
Auditor's responsibilities for the audit of the financial
statements
Our objectives are to obtain reasonable assurance about whether
the financial statements as a whole are free from material
misstatement, whether due to fraud or error, and to issue an
auditor's report that includes our opinion. Reasonable assurance is
a high level of assurance, but is not a guarantee that an audit
conducted in accordance with ISAs (UK) will always detect a
material misstatement when it exists. Misstatements can arise from
fraud or error and are considered material if, individually or in
the aggregate, they could reasonably be expected to influence the
economic decisions of users taken on the basis of these financial
statements.
A further description of our responsibilities for the audit of
the financial statements is included in the Appendix at the end of
this auditor's report. This description, which is located on page
18, forms part of our auditor's report.
Use of our report
This report is made solely in accordance with Section 80C of the
Isle of Man Companies Act 2006. Our audit work has been undertaken
so that we might state to the company's members those matters we
are required to state to them in an auditor's report and for no
other purpose. To the fullest extent permitted by law, we do not
accept or assume responsibility to anyone other than the company
and the company's members as a body, for our audit work, for this
report, or for the opinions we have formed.
RSM UK AUDIT LLP, Statutory Auditor
Chartered Accountants
Central Square
Fifth Floor
29 Wellington Street
Leeds
LS1 4DL
27 June 2018
Appendix: Auditor's responsibilities for the audit of the
financial Statements
As part of an audit in accordance with ISAs (UK), we exercise
professional judgment and maintain professional scepticism
throughout the audit. We also:
-- Identify and assess the risks of material misstatement of the
financial statements, whether due to fraud or error, design and
perform audit procedures responsive to those risks, and obtain
audit evidence that is sufficient and appropriate to provide a
basis for our opinion. The risk of not detecting a material
misstatement resulting from fraud is higher than for one resulting
from error as fraud may involve collusion, forgery, intentional
omissions, misrepresentations, or the override of internal
control.
-- Obtain an understanding of internal control relevant to the
audit in order to design audit procedures that are appropriate in
the circumstances, but not for the purpose of expressing an opinion
on the effectiveness of the group's internal control.
-- Evaluate the appropriateness of accounting policies used and
the reasonableness of accounting estimates and related disclosures
made by the directors.
-- Conclude on the appropriateness of the directors' use of the
going concern basis of accounting and, based on the audit evidence
obtained, whether a material uncertainty exists related to events
or conditions that may cast significant doubt on the group's or the
parent company's ability to continue as a going concern. If we
conclude that a material uncertainty exists, we are required to
draw attention in our auditor's report to the related disclosures
in the financial statements or, if such disclosures are inadequate,
to modify our opinion. Our conclusions are based on the audit
evidence obtained up to the date of our auditor's report. However,
future events or conditions may cause the group or the parent
company to cease to continue as a going concern.
-- Evaluate the overall presentation, structure and content of
the financial statements, including the disclosures, and whether
the financial statements represent the underlying transactions and
events in a manner that achieves fair presentation.
-- Obtain sufficient appropriate audit evidence regarding the
financial information of the entities or business activities within
the group to express an opinion on the consolidated financial
statements. We are responsible for the direction, supervision and
performance of the group audit. We remain solely responsible for
our audit opinion.
We communicate with those charged with governance regarding,
among other matters, the planned scope and timing of the audit and
significant audit findings, including any significant deficiencies
in internal control that we identify during our audit.
We also provide those charged with governance with a statement
that we have complied with relevant ethical requirements regarding
independence, including the FRC's Ethical Standard, and communicate
with them all relationships and other matters that may reasonably
be thought to bear on our independence, and where applicable,
related safeguards.
From the matters communicated with those charged with
governance, we determine those matters that were of most
significance in the audit of the consolidated financial statements
of the current period and are therefore the key audit matters. We
describe these matters in our auditor's report unless law or
regulation precludes public disclosure about the matter or when, in
extremely rare circumstances, we determine that a matter should not
be communicated in our report because the adverse consequences of
doing so would reasonably be expected to outweigh the public
interest benefits of such communication.
Consolidated Statement of Profit and Loss and Other
Comprehensive Income
For the year ended 31 December 2017
2017 2016
Notes GBP'000 GBP'000
Research and development 7 (1,185) (693)
Exceptional items 6 - (871)
Other operating costs 7 (1,422) (913)
Operating loss 7 (2,607) (2,477)
Share of loss in associates 15 (309) -
Net finance income 8 109 1
Loss before tax (2,807) (2,476)
Tax 11 573 31
Net loss for the period (2,234) (2,445)
Net loss for the period attributable
to:
Equity holders of the parent (1,744) (2,038)
Non-controlling interest (490) (407)
___________ ___________
(2,234) (2,445)
Other comprehensive income
Exchange differences on translating (47) -
foreign operations
Total comprehensive loss for the period (2,281) (2,445)
Comprehensive loss attributable to:
Equity holders of the parent (1,791) (2,038)
Non-controlling interest (490) (407)
___________ ___________
(2,281) (2,445)
Loss per ordinary share
Basic and diluted, pence per share 12 (0.05p) (0.06p)
Consolidated Balance Sheet
As at 31 December 2017
2017 2016
Notes GBP'000 GBP'000
Assets
Non-current assets
Investments 13 1,480 1,431
Intangible assets 14 1,002 1,184
Investments in associates 15 1,297 -
Prepayment 16 259 -
4,038 2,615
Current assets
Trade and other receivables 17 598 34
Cash and cash equivalents 18 570 967
1,168 1,001
Total assets 5,206 3,616
Liabilities
Current liabilities
Trade and other payables 20 (1,106) (295)
(1,106) (295)
Non-current liabilities
Loan notes 19 (2,603) (616)
Equity derivatives 19 (361) (78)
Deferred tax liabilities 11 (170) (201)
________ ________
(3,134) (895)
________ ________
Total liabilities (4,240) (1,190)
Net assets 966 2,426
Equity
Share capital 22 911 911
Reverse acquisition reserve 23 3,065 3,065
Own shares (215) (215)
Share-based payment reserves 573 382
Accumulated deficit (3,752) (2,364)
Equity attributable to equity holders
of the parent 582 1,779
Non-controlling interests 26 384 647
_________ _________
Total equity 966 2,426
The financial statements of SalvaRX Group plc were approved by
the Board of Directors and authorised for issue on
27 June 2018. They were signed on its behalf by:
Kam Shah
Chief Financial Officer
27 June 2018
Notes 1 to 28 form part of these financial statements.
Consolidated Cash Flow Statement
For the year ended 31 December 2017
2017 2016
GBP'000 GBP'000
Loss for the year (2,281) (2,445)
Adjustments for:
Taxation credit (573) (31)
Amortisation of intangible assets 182 182
Share-based payments 191 357
Finance cost 118 (1)
Share of loss in associate 309 -
Foreign exchange differences (249) -
Non-cash exceptional items - 563
________ ________
Operating cash flows before movements in working capital (2,303) (1,375)
(Increase)/decrease in receivables (76) 202
Increase/(decrease) in payables 434 (332)
________ ________
Cash used in operations (1,945) (1,505)
Taxation received 54 -
________ ________
Net cash outflow from operating activities (1,891) (1,505)
Investing activities
Cash acquired through reverse acquisition - 2,564
Purchase of trading investments - (1,431)
Investments in associates (1,413) -
Prepaid equity option (note 16) (259) -
________ ________
Net cash used in/obtained from investing activities (1,672) 1,133
________ ________
Financing activities
Proceeds on issue of loan notes 3,119 760
________ ________
Net cash from financing activities 3,119 760
________ ________
Net (decrease)/increase in cash and cash equivalents (444) 388
Cash and cash equivalents at beginning of year 967 567
Effect of exchange rate on cashflow 47 12
________ ________
Cash and cash equivalents at end of year 570 967
Consolidated Statement of Changes in Equity
For the year ended 31 December 2016
Equity attributable to equity holders of the parent
Share-
Reverse based
acquisition payment Non-
Share capital Share reserve reserves Accumulated controlling Total
(note 22) Premium (note 23) Own shares (note deficit Total interest equity
24)
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
At 1 January 1,693
2016 155 52,533 (51,748) - 25 (326) 639 1,054
Net loss of (2,445)
the year - - - - - (2,038) (2,038) (407)
------------------ ------------- ---------------- ----------------- ------------- --------------------- ------------ -------------------- --------------
Total
comprehensive
income - - - - - (2,038) (2,038) (407) (2,445)
------------------ ------------- ---------------- ----------------- ------------- --------------------- ------------ -------------------- --------------
Transactions
with owners
in their
capacity
as owners:
- Issue of
equity for
cash 136 1,813 (1,949) - - - - - -
- Cost of
share issue - (173) 173 - - - - - -
- Reverse
acquisition 620 8,180 (5,764) (215) - - 2,821 - 2,821
Cancellation
of share
premium
account - (62,353) 62,353 - - - - -
Share based
payment 357
charge - - - 357 - 357 -
------------------ ------------- ---------------- ----------------- ------------- --------------------- ------------ -------------------- --------------
Total
transactions
with
owners in
their
capacity as
owners 756 (52,533) 54,813 (215) 357 - 3,178 - 3,178
------------------ ------------- ---------------- ----------------- ------------- --------------------- ------------ -------------------- --------------
At 31 December
2016 911 - 3,065 (215) 382 (2,364) 1,779 647 2,426
------------------ ------------- ---------------- ----------------- ------------- --------------------- ------------ -------------------- --------------
Consolidated Statement of Changes
in Equity
For the year ended 31 December 2017
Share-
Reverse based
acquisition payment Non-
Share capital reserve reserves Accumulated controlling Total
(note 22) (note 23) Own shares (note deficit Total interest equity
24)
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
At 1 January
2017 911 3,065 (215) 382 (2,364) 1,779 647 2,426
Net loss of
the year - - - - (1,744) (1,744) (490) (2,234)
Foreign
exchange gain
on
retranslation
of foreign
subsidiaries - - - - (47) (47) - (47)
Total
comprehensive
income - - - - (1,791) (1,791) (490) (2,281)
------------------ --------------- ----------------- ------------- --------------------- ----------- -------------------- --------------
Transactions
with owners
in their
capacity
as owners:
- Conversion
of 2016 loan
notes (note
26) - - - - 482 482 148 630
- Equity
contribution to
non-controlling
shareholders
(note 26) - - - - (79) (79) 79 -
- Share based
payment
charge - - - 191 - 191 - 191
------------------ --------------- ----------------- ------------- --------------------- ----------- -------------------- --------------
Total
transactions
with
owners in their
capacity as
owners - - - 191 403 594 227 821
------------------ --------------- ----------------- ------------- --------------------- ----------- -------------------- --------------
At 31 December
2017 911 3,065 (215) 573 (3,752) 582 384 966
------------------ --------------- ----------------- ------------- --------------------- ----------- -------------------- --------------
Notes to the financial statements
For the year ended 31 December 2017
1 General information
SalvaRx Group plc (the 'Company' and, together with its
subsidiaries, the 'Group') is incorporated in the Isle of Man,
British Isles under the Isle of Man Companies Act 2006. The address
of the registered office is Commerce House, 1 Bowring Road, Ramsey,
Isle of Man, British Isles, IM8 2LQ.
The principal activity of the Group is drug development,
pre-clinical development with particular focus on developing a
series of compounds for cancer immunotherapy.
These financial statements are presented in pounds sterling,
which is the Group's functional and presentational currency, and
all values are rounded to the nearest thousands (GBP000) except
loss per ordinary share and certain figures in the notes.
2 Adoption of new and revised Standards
Interpretations of Standards
There are no new standards or amendments to standards which are
mandatory for the first time for the year ended 31 December 2017
which have a significant impact on the Group. The potential impacts
of IFRS 15, Revenue from contracts with customers, IFRS 9,
Financial Instruments and IFRS 16 Leases, are being assessed by
management. The Board do not expect that the adoption of these
Standards in future periods will have a material impact on the
financial statements of the company.
3 Summary of significant accounting policies
Basis of accounting
The financial statements have been prepared in accordance with
International Financial Reporting Standards ("IFRSs") as issued by
the International Accounting Standards Board ("IASB") and as
adopted by the European Union ("EU"), and therefore the Group
financial statements comply with Article 4 of the EU IAS
Regulation.
The financial statements have been prepared on the historical
cost convention basis except for the valuation of certain financial
instruments held at fair value through profit or loss. Historic
cost is generally based on the fair value of the consideration
given in exchange for the assets. The principal accounting policies
adopted are set out below.
Going concern
The Group's business activities, together with the factors
likely to affect its future development and position, are set out
in the Directors' Report.
The consolidated financial statements of the group have been
prepared on a basis which assumes that the Group will continue as a
going concern, which contemplates the realisation of assets and
satisfaction of liabilities and commitments in the normal course of
business.
At 31 December 2017, the Group had cash and cash equivalent of
approximately GBP0.6 million. Subsequently, on 8 March 2018, IOX
Therapeutics raised $1m through the issue of a convertible loan and
on 26 June 2018 it was announced that a $1m loan was secured by the
Company.
The Board has prepared cash flow forecasts for the period
through to June 2019. The forecasts indicate that further funding
will be required over and above existing resources and this
includes repayment of the $1m loan issued on 26 June 2018 which is
repayable within one year. However, the Directors have prepared
these financial statements on the basis that Jim Mellon and Dr Greg
Bailey will continue to provide financial support necessary for the
group to meet its liabilities as they fall due.
The Group continues to incur losses and transition to
profitability is dependent upon achieving a level of revenues
adequate to support the Group's cost structure and until doing so,
intends to fund future operations through additional debt or equity
offerings. Because additional financing is not committed at the
date of approval of these financial statements, these circumstances
represent a material uncertainty as to the Group's ability to
continue as a going concern. Should the Group be unable to obtain
further finance such that the going concern basis of preparation
were no longer appropriate, adjustments would be required including
to reduce balance sheet values of assets to their recoverable
amounts, to provide for further liabilities that might arise and to
reclassify non-current assets as current assets.
Basis of consolidation
The consolidated financial statements incorporate the financial
statements of the Company and entities controlled by the Company
(its subsidiaries) made up to 31 December each year. Control is
achieved where the Company has the power to govern the financial
and operating policies of an investee entity so as to obtain
benefits from its activities.
The results of subsidiaries acquired or disposed of during the
year are included in the consolidated income statement from the
effective date of acquisition or up to the effective date of
disposal, as appropriate. Where necessary, adjustments are made to
the financial statements of subsidiaries to bring accounting
policies used into line with those used by the Group. All
intra-Group transactions, balances, income and expenses are
eliminated on consolidation.
These consolidated financial statements include the accounts of
the Company and the following subsidiary undertakings:
i) SalvaRx Limited, ("SalvaRx") incorporated on 6 May 2015 in
the British Virgin Islands. SalvaRx Group plc owns 94.15% of the
Company.
ii) IOX Therapeutics Limited ("IOX") incorporated in the U.K. as
a private company (Company Number 9430782) under the Companies Act
2006 on 10 February 2015. SalvaRx Group plc holds 56.95% equity in
IOX.
iii) Saugatuck Therapeutics Limited incorporated in the British
Virgin Islands. SalvaRx Limited holds 70% equity in the
company.
Significant accounting policies
Research and Development Expenses
(i) Research and development
Expenditure on research activities, undertaken with the prospect
of gaining new scientific or technical knowledge and understanding,
is recognized in profit or loss as incurred.
Development activities involve a plan or design for the
production of new or substantially improved products and processes.
Development expenditures are capitalized only if development costs
can be measured reliably, the product or process is technically and
commercially feasible, future economic benefits are probable, and
the Company intends to and has sufficient resources to complete
development and to use or sell the asset. No development costs have
been capitalized to date.
Research and development expenses include all direct and
indirect operating expenses supporting the products in
development.
(ii) Subsequent expenditure
Subsequent expenditure is capitalized only when it increases the
future economic benefits embodied in the specific asset to which it
relates. All other expenditures are recognized in profit or loss as
incurred.
(iii) Clinical trial expenses
Clinical trial expenses are a component of the Company's
research and development costs. These expenses include fees paid to
contract research organizations, clinical sites, and other
organizations who conduct development activities on the Company's
behalf. The amount of clinical trial expenses recognized in a
period related to clinical agreements are based on estimates of the
work performed using an accrual basis of accounting. These
estimates incorporate factors such as patient enrolment, services
provided, contractual terms, and prior experience with similar
contracts.
(iv) Government grants
Government grants relate to the financial grants from
governments, public authorities, and similar local, national or
international bodies. These are recognised when there is a
reasonable assurance that the Company will comply with the
conditions attaching to them, and that the grant will be received.
Government grants relating to research and development are off-set
against the relevant costs.
Business Combinations
The Company applies the acquisition method to account for all
acquired businesses, whereby the identifiable assets acquired and
the liabilities assumed are measured at their acquisition-date fair
values.
The consideration transferred in a business combination is
measured at fair value, which is calculated as the sum of the
acquisition-date fair values of the assets transferred, the
liabilities incurred and the equity interests issued by the
Company.
Acquisition-related costs (e.g. finder's fees, consulting fees,
administrative costs, etc.) are recognized as expenses in the
periods in which the costs are incurred and the services are
received. On acquisition date, goodwill is measured as the excess
of the aggregate of consideration transferred, any non-controlling
interests in the acquiree, and acquisition-date fair value of the
Company's previously held equity interest in the acquiree (if
business combination achieved in stages) over the net of the
acquisition-date amounts of the identifiable assets acquired and
the liabilities assumed.
At acquisition date, non-controlling interests in the acquiree
that are present ownership interests and entitle their holders to a
proportionate share of the entity's net assets in the event of
liquidation are measured at either fair value or the present
ownership instruments' proportionate share in the recognized
amounts of the acquiree's identifiable net assets. This choice of
measurement is made separately for each business combination. Other
components of non-controlling interests are measured at their
acquisition-date fair values, unless otherwise required by
IFRS.
Impairment of intangible assets other than goodwill
At the end of each reporting period, the Group reviews the
carrying amounts of its intangible assets to determine whether
there is any indication that those assets have suffered an
impairment loss. If any such indication exists, the recoverable
amount of the asset is estimated in order to determine the extent
of the impairment loss (if any). When it is not possible to
estimate the recoverable amount of any individual asset, the Group
estimates the recoverable amount of the cash-generating unit to
which the asset belongs. When a reasonable and consistent basis of
allocation can be identified, corporate assets are also allocated
to individual cash-generating units, or otherwise they are
allocated to the smallest group of cash-generating units for which
a reasonable and consistent allocation basis can be identified.
Intangible assets with indefinite useful lives and intangible
assets not yet available for use are tested for impairment at lease
annually, and wherever there is an indication that the assets may
be impaired.
Recoverable amount is the higher of fair value less costs of
disposal and value in use. In assessing value in use, the estimated
future cash flows are discounted to their present value using a
pre-tax discount rate that reflects current market assessments of
the time value of money and the risks specific to the asset for
which the estimates of future cash flows have not been
adjusted.
Investments in associates
An associate is an entity over which the Group has significant
influence. Significant influence is the power to participate in the
financial and operating policy decisions of the investee but is not
control or joint control over those policies.
The results and assets and liabilities of associates are
incorporated in these consolidated financial statements using the
equity method of accounting, except when the investment, or a
portion thereof, is classified as held for sale, in which case it
is accounted for in accordance with IFRS 5. Under the equity
method, an investment in an associate is initially recognised in
the consolidated statements of financial position at cost and
adjusted thereafter to recognise the Group's share of the profit or
loss and other comprehensive income of the associate. When the
Group's share of losses of an associate exceeds the Group's
interest in that associate (which includes any long-term interest
that, in substance, form part of the Group's net investment in the
associate), the Group discontinues recognising its share of further
losses. Additional losses are recognised only to the extent that
the Group has incurred legal or constructive obligations or made
payments on behalf of the associate.
Intangible Assets Acquired in business combinations
Intangible assets acquired in a business combination and
recognised separately from goodwill are initially recognised at
their fair value at the acquisition date (which is regarded as
their cost).
Subsequent to initial recognition, intangible assets acquired in
a business combination are reported at cost less accumulated
amortisation and accumulated impairment losses, on the same basis
as intangible assets that are acquired separately.
Foreign currencies
The individual financial statements of each Group company are
presented in the currency of the primary economic environment in
which it operates (its functional currency).
For the purpose of the consolidated financial statements, the
results and financial position of each Group company are expressed
in pounds sterling, which is the functional currency of the
Company, and the presentation currency for the consolidated
financial statements.
In preparing the financial statements of the individual
companies, transactions in currencies other than the functional
currency of each Group company ("foreign currencies") are recorded
in the functional currency at the rates of exchange prevailing on
the dates of the transactions. At each balance sheet date, monetary
assets and liabilities that are denominated in foreign currencies
are retranslated into the functional currency at the rates
prevailing on the balance sheet date. Non-monetary assets and
liabilities carried at fair value that are denominated in foreign
currencies are translated at the rates prevailing at the date when
the fair value was determined. Non-monetary items that are measured
in terms of historical cost in a foreign currency are not
retranslated.
For the purpose of presenting consolidated financial statements,
the assets and liabilities of the group's foreign operations are
translated at exchange rates prevailing on the balance sheet date.
Income and expense items are translated at the average exchange
rates for the period, unless exchange rates fluctuate significantly
during the period, in which case the exchange rates at the date of
transactions are used. Exchange differences arising, if any, are
recognised in other comprehensive income and accumulated in equity
(attributed to non-controlling interest as appropriate).
Taxation
The tax expense represents the sum of the tax currently payable
and deferred tax.
The tax currently payable is based on taxable profit for the
year. Taxable profit differs from net profit as reported in the
income statement because it excludes items of income or expense
that are taxable or deductible in other years, and it further
excludes items that are never taxable or deductible. The Group's
liability for current tax is calculated using tax rates that have
been enacted or substantively enacted by the balance sheet
date.
Deferred tax is the tax expected to be payable or recoverable on
differences between the carrying amounts of assets and liabilities
in the financial statements and the corresponding tax bases used in
the computation of taxable profit, and is accounted for using the
balance sheet liability method. Deferred tax liabilities are
generally recognised for all taxable temporary differences, and
deferred tax assets are recognised to the extent that it is
probable that taxable profits will be available against which
deductible temporary differences can be utilised. Such assets and
liabilities are not recognised if the temporary difference arises
from the initial recognition of goodwill, or from the initial
recognition (other than in a business combination) of other assets
and liabilities in a transaction that affects neither the tax
profit nor the accounting profit.
Deferred tax liabilities are recognised for taxable temporary
differences arising on investments in subsidiaries and associates,
and interests in joint ventures, except where the Group is able to
control the reversal of the temporary difference and it is probable
that the temporary difference will not reverse in the foreseeable
future.
The carrying amount of deferred tax assets is reviewed at each
balance sheet date and reduced to the extent that it is no longer
probable that sufficient taxable profits will be available to allow
all or part of the asset to be recovered.
Deferred tax is calculated at the tax rates that are expected to
apply in the period when the liability is settled or the asset is
realised. Deferred tax is charged or credited in the income
statement, except when it relates to items charged or credited
directly to equity, in which case the deferred tax is also dealt
with in equity.
Deferred tax assets and liabilities are offset when there is a
legally enforceable right to set off current tax assets against
current tax liabilities and when they relate to income taxes levied
by the same taxation authority and the Group intends to settle its
current tax assets and liabilities on a net basis.
Financial instruments
Recognition of financial assets and financial liabilities
Financial assets and financial liabilities are recognised on the
Group's balance sheet when the Group becomes a party to the
contractual provisions of the instrument.
Derecognition of financial assets and financial liabilities
The Group derecognises a financial asset only when the
contractual rights to cash flows from the asset expire, or it
transfers the financial asset and substantially all the risks and
rewards of ownership of the asset to another entity. If the Group
neither transfers nor retains substantially all the risks and
rewards of ownership and continues to control the transferred
asset, the Group recognises its retained interest in the asset and
an associated liability for the amount it may have to pay.
The Group derecognises financial liabilities when the Group's
obligations are discharged, cancelled or expired.
Financial assets
a) Investments - Available for sale financial assets
AFS financial assets are non-derivatives that are not classified
as loans and receivables, held-to-maturity investments or financial
assets at fair value through profit or loss. The Group's AFS
investment does not have a quoted market price in an active market
and given their nature the Directors are of the opinion that fair
value cannot be reliably be measured. The investment is therefore
measured at cost, less any identified impairment loss.
b) Loans and receivables
Trade and other receivables
Trade and other receivables are measured at initial recognition
at fair value and are subsequently measured at amortised cost less
any
provision for impairment.
Cash and cash equivalents
Cash and cash equivalents comprise cash in hand and on-demand
deposits, and other short-term highly liquid investments that are
readily convertible to a known amount of cash with three months or
less remaining to maturity and are subject to an insignificant risk
of changes in value.
Derivative financial assets
Derivative financial assets comprise an option contract to
acquire the remaining ordinary share capital of an entity related
to an associate of the group. Derivative financial assets are
carried at fair value, with gains and losses arising from changes
in fair value taken directly to the Statement of Comprehensive
Income. Fair values of derivatives are determined using valuation
techniques, including discounted cash flow models and option
pricing models as appropriate.
Financial liabilities
Trade and other payables
Trade payables are initially measured at fair value, and are
subsequently measured at amortised cost, using the effective
interest rate method.
2016 Convertible loan notes
The component parts of compound instruments (convertible loan
notes) issued by the Group in 2016 are classified separately
between the loan and equity option elements. The Group had one
convertible loan note in issue which was denominated in a currency
different to the currency of the equity option and accordingly at
inception the equity option is treated as an embedded derivative
and recorded at fair value as a financial liability (the "equity
option") and the fair value of the instrument as a whole less the
value of the equity option is recorded as a financial liability
(the "loan element"). At subsequent balance sheet dates the fair
value of the equity option is remeasured with movements in fair
value being recorded in the income statement. The loan element is
recorded at amortised cost and is subject to a notional interest
charge in each reporting period which is recorded in the income
statement.
During the year the 2016 convertible loan notes were converted
into shares in SalvaRx Limited, the group's subsidiary undertaking.
As the equity was issued by a subsidiary undertaking, the equity
credit has been allocated to reserves between the parent company
shareholders and the non-controlling interest.
2017 loan notes
As detailed in note 19, the 2017 loan notes comprise a loan and
a warrant over shares in SalvaRx Limited. At inception the loan
element and the warrant are recorded at their respective fair
values. The fair value of the loan is calculated by determining an
effective rate of interest determined by reference to the interest
rate applicable to comparable instruments with no warrant. The fair
value of the warrant is determined as the difference between the
fair value of the instrument issue price and the fair value of the
loan.
At subsequent balance sheet dates the loan is measured at
amortised cost and the warrant is measured at fair value.
Share-based payments
The Group has applied the requirements of IFRS 2 Share-based
Payment for all grants of equity instruments.
The Group operates an equity-settled share option plan to
certain shareholders. The fair value of the service received in
exchange for the grant of options and warrants is recognised as an
expense. Equity-settled share-based payments are measured at fair
value (excluding the effect of non-market based vesting conditions)
at the date of grant. The fair value determined at the grant date
of equity-settled share-based payment is expensed on a graded
vesting basis over the vesting period, based on the Group's
estimate of shares that will eventually vest and adjusted for the
effect of non-market based vesting conditions.
Fair value is measured by use of the Black-Scholes model. The
expected life used in the models has been adjusted, based on
management's best estimate, for the effects of non-transferability,
exercise restrictions, and behavioural considerations.
Segmental reporting
Operating segments are reported in a manner consistent with the
internal reporting provided to the chief operating decision maker.
The chief operating decision maker, who is responsible for
allocating resources and assessing performance of the operating
segments and making strategic decision, has been identified as the
Board of Directors.
4 Critical accounting judgements and key sources of estimation and uncertainty
In the application of the Group's accounting policies, which are
described in note 3, the Directors are required to make judgements,
estimates and assumptions about the carrying amounts of the assets
and liabilities that are not readily apparent from other sources.
The estimates and associated assumptions are based on historical
experience and other factors that are considered to be relevant.
Actual results may differ from these estimates.
The estimates and underlying assumptions are reviewed on an
ongoing basis. Revisions to accounting estimates are recognised in
the period in which the estimate is revised if the revision affects
only that period or in the period of the revision and future
periods if the revision affects both the current and future
periods.
The following are the critical judgements and estimations that
the Directors have made in the process of applying the Group's
accounting policies and that have the most significant effect on
the amounts recognised in the financial statements:
2017 loan notes (note 19)
The 2017 loan notes include a warrant over shares in SalvaRx
Limited and IFRS requires the instrument to be separated at
inception into the fair value of the loan and the fair value of the
warrant. IFRS's default position is that the warrant should be fair
valued, however the Directors have concluded that it is not
possible to ascertain the fair value of the warrant using normal
option pricing models due to the complexity of the option exercise
mechanism. The Directors have therefore adopted the permitted
alternative method of calculating the fair value of the loan at
inception, with the balance between the issue price of the
instrument and the fair value of the loan being deemed to be the
fair value of the warrant.
Accordingly, the fair value of the loan has been calculated by
discounting future cash flows using rates of interest applicable to
similar instruments with no warrant. The directors have used an
interest rate of 11%. The selection of comparable instruments is a
matter of judgement, and changes in the rate used in the
discounting calculation would have a material impact on the split
between the loan and warrant fair values.
At the year end the loan is stated at amortised cost based on
the imputed rate of interest. The warrant is stated at fair value
which the Directors have determined has not changed from when the
instruments were issued given that the instrument was issued
throughout the year on the same terms.
Adoption of cost for available for sale assets (note 13)
Available for sale investments comprises an investment in
Intensity Therapeutics Inc. of GBP1,480,000 at 31 December 2017.
The Directors' have exercised judgement in determining that the
investment should be recorded at cost in accordance with paragraph
46 c) of IAS 39 as they have concluded that it is not possible to
ascertain a reliable fair value for the investment.
This conclusion reflects the reality that the speculative nature
of the group's investment results in a very wide potential range of
values (supported by a recently commissioned valuation report) and
the adoption of fair value would likely result in the reliability
of the overall financial statements being undermined.
5 Business and geographical segments
Throughout the year, the Directors consider there to be only one
business and operating segment from continuing operations, namely
research and development.
6 Exceptional items
Year ended Year ended
31 December 31 December
2017 2016
GBP'000 GBP'000
Excess of deemed cost over fair value of
assets acquired under reverse takeover transaction - 563
Legal and other professional fees relating
to reverse takeover transaction - 308
- 871
7 Operating loss
The operating loss has been arrived at after 2017 2016
(crediting)/charging: GBP'000 GBP'000
Research and development costs 1,185 693
Amortisation of intangible assets 182 182
Staff costs (note 10) 287 203
Other consulting fees 429 143
Legal and professional fees 230 77
Share-based payments (note 24) 191 357
Audit fees (note 9) 38 37
Net foreign exchange gains (47) (95)
8 Net finance (income)
2017 2016
GBP'000 GBP'000
Movement in fair value of equity option on
2016 loan notes (note 19) (78) (133)
Loan note interest 196 46
Foreign exchange (gains)/losses on all loan
notes (note 19) (227) 86
(109) (1)
The loan note interest charge of 11% from the date of issue
includes cash interest of GBP110,000 (at 7% coupon and included
within accruals) and notional interest of GBP86,000 which is
included at note 19.
9 Auditor's Remuneration
Amounts payable to RSM UK Audit LLP and its associates in
respect of both audit and non-audit services:
2017 2016
GBP'000 GBP'000
Audit fees
Fees payable to the Group's auditor for the
statutory audit of the Group's annual accounts 30 29
Fees payable to the Group's auditor for the
statutory audit of subsidiary undertakings 8 8
Total audit fees 38 37
Non-audit fees
Tax services 4 2
Other services 9 -
Total non-audit fees 13 2
10 Staff costs
The average monthly number of employees and senior management
(including Executive Directors) was:
2017 2016
GBP'000 GBP'000
Non-executive Directors 4 4
Executive Directors of Group companies 2 2
6 6
2017 2016
Their aggregate remuneration comprised: GBP'000 GBP'000
Salaries and consulting fee 287 203
Share-based payments 71 138
Non-executive directors fees 40 52
398 393
Directors remuneration (all representing fees) and share based
payments
2017 2016
GBP'000 GBP'000
J Mellon (from 22 March 2016) 10 8
G Bailey (from 22 March 2016) 10 8
R Armstrong (from 22 March 2016) 17 26
C Weinberg (from 22 March 2016) 17 26
I Walters (from 1 January 2016) 229 220
K Shah (from 22 March 2016) 116 105
399 393
Details of shares and options held by the Directors are
disclosed in the Directors' report.
11 Tax
UK income tax recognised in profit and loss
2017 2016
GBP'000 GBP'000
Current tax
Current year (300) -
Adjustment in respect of prior years (242) -
(542) -
Deferred tax
Current year (31) (31)
(31) (31)
Total taxation credit (573) (31)
The tax assessed for the year is at the standard rate of
corporation tax in the Isle of Man of 0%
(2016: 0%) and is calculated as follows:
2017 2016
GBP'000 GBP'000
Loss on ordinary activities before tax (2,854) (2,476)
Loss on ordinary activities by the standard - -
rate of tax
Foreign tax - -
Release of deferred tax related to subsidiaries
operating in other jurisdictions (31) (31)
Research and development tax credits (542) -
Tax credit for the year (573) (31)
The Company's subsidiary, iOx Therapeutics ltd ("iOx") is
subject to tax in the UK. There is no tax charge for the reporting
periods due to losses.
iOx has potential research and development cash credits of
approximately GBP300,000 for 2017. The tax credits have been
recognised in these financial statements. The tax credit in respect
of prior years relates to GBP54,000 for 2015 and GBP188,000 for
2016. The GBP54,000 relating to 2015 was received during the year
as shown in the consolidated cash flow statement.
Deferred Taxation
As at 31December 2017, iOx tax losses were approximately
GBP785,000 (2016: GBP1,045,000). Tax losses will be carried forward
and are potentially available for utilisation against taxable
profits in future years. The Group has not recognised a deferred
tax asset in respect of these tax losses as there is insufficient
evidence of suitable future profit being available against which
these losses can be offset. The asset will be recognised in future
periods when its recovery (against appropriate taxable profits) is
considered probable.
At 31December 2017 the Group had a deferred tax liability of
GBP170,000 (2016: GBP201,000) recognised in respect of intangible
assets arising on the acquisition of iOx. The intangible asset
relates to in process research residing in the UK and therefore
deferred tax has been recorded at 17% being the rate applicable in
that country. The Group has no other provided or unprovided
deferred tax liabilities. The reduction in the liability in the
year of GBP31,000 (2016: GBP31,000) has been recorded in full in
the income statement.
12 Loss per Ordinary Share
Basic loss per Ordinary Share is calculated by dividing the net
loss for the year attributable to Ordinary equity holders of the
parent by the weighted average number of Ordinary Shares
outstanding during the year. The calculation of the basic and
diluted loss per Ordinary Share is based on the following data:
2017 2016
GBP'000 GBP'000
Losses
Loss for the purposes of basic loss per share
being net loss attributable to equity holders
of the parent 1,744 2,038
Number of shares Number Number
Weighted average number of Ordinary Shares
for the purposes of basic loss per share 36,467,123 34,561,950
2017 2016
GBP GBP
Loss per Ordinary Share
Basic and diluted, pence per share (0.05p) (0.06p)
------------- _________
Dilutive loss per Ordinary Share equals basic loss per Ordinary
Share as, due to the losses incurred in 2017 and 2016, there is no
dilutive effect from the subsisting share options.
13 Investments
2017 2016
GBP'000 GBP'000
Available for sale-investments held at cost
Investment in Intensity 1,480 1,395
Loan receivable at amortised cost
RIFT loan (note 15) - 36
1,480 1,431
On 22 April 2016, the Group acquired 1 million Series A
preferred stock in Intensity Therapeutics Inc., a Delaware
corporation ("Intensity") for US$2m in cash. All Series A Preferred
stock is convertible into equal number of common shares in
Intensity. The Company's holdings represent less than 10% of the
equity of Intensity. During the current year the company
transferred its investment to its subsidiary SalvaRx Limited.
As at 31 December 2017, the Group has determined that there was
no evidence of any impairment in the carrying value of
investments.
14 Intangible assets
In process
research
GBP'000
Cost
At 31 December 2015, 2016 and 2017 1,457
Amortisation
At 1 January 2016 (91)
Charge for the year (182)
At 31 December 2016 (273)
Charge for the year (182)
At 31 December 2017 (455)
Carrying amounts
At 31 December 2015 1,366
At 31 December 2016 1,184
At 31 December 2017 1,002
On 1 July 2015, iOx Therapeutics Limited ("iOx") entered into an
Investment Agreement with The University of Oxford, ISIS, the
Ludwig Institute, and Professor Cerundolo. As part of this
agreement, iOx also entered into a Clinical Trials Sponsorship
agreement with The University of Oxford and entered into a licence
agreement with the Ludwig Institute to access intellectual property
rights and know-how relating to cell agonists. The Directors
determined that the excess of consideration over identifiable
assets and liabilities arising on the acquisition of iOx on that
date related entirely to this in-process research asset.
The asset is being amortised over 8 years, being the Directors
assessment of the period over which the technologies are likely to
be developed and at the end of which commercial products will
hopefully be available for sale. The remaining life of the
intangible asset is 5.5 years. In the opinion of the Directors, the
progress of iOx is satisfactory and there is therefore no
indication of impairment.
15 Investments in associates
Rift Nekonal Total
Biotherapeutics Oncology GBP'000
Inc Limited
GBP'000 GBP'000
At 1 January 2017 - - -
Transfer from investments 36 - 36
Additions to investment 1,155 525 1,680
Exchange gains and losses (110) - (110)
1,081 525 1,606
Share of loss in associates (266) (43) (309)
At 31 December 2017 815 482 1,297
Details of the Group's material associates at the end of the
reporting period are as follows:
Voting rights held by
the Group
31 December 31 December
Place of incorporation 2017 2016
Principal and principal
Name of associate activity place of business
RIFT Biotherapeutics Biotechnology Delaware -
Inc. USA San Diego 34.99% -
Nekonal Oncology British Virgin
Limited Oncology research Islands 31.07% -
All of the above associates are accounted for using the equity
method in these consolidated financial statements.
Rift Biotherapeutics Inc. ("RIFT")
On 13 December 2016, SalvaRx Limited, a wholly owned subsidiary
of the Company, invested US$45,000 in cash in convertible
promissory note issued by Rift Biotherapeutics Inc., a Delaware
corporation ('RIFT").
On 9 February 2017, SalvaRx Limited advanced a further US$45,000
and on 20 March 2017, SalvaRx invested US$ 1 million in RIFT. The
total investment of US$1,090,000 in RIFT was converted into a 33%
equity holding.
On 6 December 2017, SalvaRx Limited acquired a further 251,798
of Series A preferred stock for a total consideration of
US$349,999. This increased the Group's interest to 34.99%.
Subject to RIFT achieving certain development milestones,
SalvaRx Limited has an obligation to acquire a further 467,626 of
Series A preferred stock for a total consideration of US$650,000.
As the directors currently consider the achievement of the
development milestones to be possible but not certain this
obligation has been accounted for as a contingent liability, see
note 28.
In addition, SalvaRx Limited also has the option to invest up to
an additional US$500,000 at the same value of its original
investment. SalvaRx Limited has also entered an option to acquire
all outstanding shares of RIFT in exchange for new shares in
SalvaRx Limited on the same basis within 90 days of the milestone
investment referred to above being achieved.
Nekonal Oncology Limited ("Nekonal Oncology")
SalvaRx Limited, a subsidiary of the Group, has entered into an
agreement to invest in and form a collaboration with Nekonal SARL
("Nekonal"), a Luxembourg-based company holding intellectual
property rights for therapeutics and diagnostics in the field of
autoimmune disorders and oncology. As part of the agreement,
SalvaRx and Nekonal have formed Nekonal Oncology, which will
utilise SalvaRx's management and drug development expertise to
exclusively explore the applications of Nekonal's technology in
cancer immunotherapy.
SalvaRx Limited has made a nominal equity investment and a
capital contribution of EUR300,000 in Nekonal Oncology. Nekonal
Oncology has been treated as an associate company by the Group as
the equity interest is 33%.
SalvaRx Limited has an obligation to make a further capital
contribution of EUR300,000 once certain development milestones have
been achieved, as the milestones were expected to be achieved when
the investment was made this obligation of GBP267,000 has been
included in other creditors see note 20.
SalvaRx Limited also has acquired an option from Nekonal SARL
for a one-time fee of EUR300,000 that gives SalvaRx the right to
acquire option shares in any qualifying subsidiary of Nekonal.
Further disclosure is provided in note 16.
Summarised financial information in respect of each of the
associates is set out below.
2017
RIFT Biotherapeutics GBP'000
Current assets 158
Non current assets 35
Current liabilities (32)
161
2017
GBP'000
Revenue -
Profit/(loss) for the year (907)
Reconciliation of the above summarised financial information to
the carrying amount of the interest in RIFT:
2017
GBP'000
Net assets of the associate 161
Proportion of the groups ownership
interest (34.99%) 56
Goodwill 759
Carrying amount of groups interest 815
2017
Nekonal Oncology Limited GBP'000
Current assets 502
Non current assets -
Current liabilities (130)
372
2017
GBP'000
Revenue -
Profit/(loss) for the year (139)
Reconciliation of the above summarised financial information to
the carrying amount of the interest in Nekonal Oncology
Limited:
2017
GBP'000
Net assets of the associate 372
Proportion of the Groups ownership
interest (31.07%) 116
Goodwill 366
Carrying amount of Groups interest 482
16 Prepayment - non current
2017 2016
GBP'000 GBP'000
Prepayment (note 15) 259 -
259 -
SalvaRx Limited has acquired an option from Nekonal SARL for a
one-time fee of EUR300,000 that gives SalvaRx the right to acquire
option shares in any qualifying subsidiary of Nekonal for EUR50 per
share subject to SalvaRx having made a total of EUR600,000 of
capital contributions to Nekonal Oncology Limited. As at 31
December 2017 SalvaRx has made EUR300,000 of capital contributions
and has an obligation to make a further capital contribution of
EUR300,000 once certain development milestones have been achieved.
This obligation of GBP267,000 has been included in other creditors.
Subject to this further investment the option is exercisable at any
time within four years of the option agreement dated 27 February
2017.
17 Trade and other receivables
2017 2016
GBP'000 GBP'000
Amount due from associates 21 -
VAT and corporation tax recoverable 498 5
Prepayments 79 29
598 34
18 Cash and cash equivalents
Cash and cash equivalents as at 31 December 2017 of
approximately GBP0.57 million (As at 31 December 2016: GBP0.97
million) comprise cash held by the Group. The Directors consider
that the carrying amount of these assets approximates to their fair
value.
19 Loan Notes
Convertible Equity option 2017 Warrants Total
loan on convertible Loan on 2017 GBP'000
notes 2016 2016 loan notes loan notes
GBP'000 GBP'000 GBP'000 GBP'000
At 31 December 2016 616 78 - - 694
New loans in the year - - 2,734 385 3,119
Imputed interest 13 - 73 - 86
Change in fair value - (78) - - (78)
Equity contribution
on conversion (630) - - - (630)
Exchange gains and
losses 1 - (204) (24) (227)
31 December 2017 - - 2,603 361 2,964
On 2 March 2017, the liability on the 2016 convertible loan
notes was transferred to SalvaRx Limited and the note holders
immediately converted their loan notes into shares in SalvaRx
Limited at a price of US $250 per share. This gave rise to a 5.85%
equity non-controlling interest in SalvaRx Limited and a credit of
GBP630,000 has been recorded in equity.
On 2 March 2017, the Company announced an offering by its
subsidiary SalvRx Limited of unsecured loan notes of up to US $5
million, carrying a coupon of 7% and repayable in four years. The
loan notes were subscribed in tranches during the year. The holders
of the loan notes were issued US $7,500 of warrant in respect of
each US $10,000 loan note. The warrants vest in the event of a
qualifying transaction and are exercisable at a price of the higher
of US $250 per share and a price reflecting discount to the implied
valuation of SalvaRx Limited. SalvaRx Limited raised US $3,940,000
in unsecured loan notes from the offering reflecting a sterling
value of GBP3,119,000 on issue.
The coupon interest of 7% arising on the 2017 loan notes is
included within accruals as it is payable within one year.
20 Trade and other payables
2017 2016
GBP'000 GBP'000
Trade payables 488 224
Other creditors (note 15) 267 -
Accruals 162 71
Directors loan account (note 25) 189 -
1,106 295
Trade payables and accruals principally comprise amounts
outstanding for trade purchases and on-going costs. The average
credit period taken for trade purchases is 45 days (2016: 40 days).
The Group has financial risk management policies to ensure that all
payables are paid within the credit timeframe. The Directors
consider that the carrying amount of trade and other payables
approximates to their fair value. No interest is generally charged
on balances outstanding.
Other creditors comprising funding obligations to Nekonal
Oncology Limited, as disclosed in note 15.
21 Financial instruments
Capital risk management
The Group manages its capital resources so as to ensure that
entities in the Group will be able to continue as a going concern,
while maximising the return to shareholders. Until it achieves
positive cash-flow, the Group expects to fund its operations
through a combination of equity capital raised from the market and,
where appropriate, debt finance.
The capital resources of the Group consist of cash and cash
equivalents arising from equity attributable to equity holders of
the parent, comprising issued capital, reserves and retained
earnings as disclosed in the Consolidated Statement of Changes in
Equity.
Externally imposed capital requirement
The Group is not subject to externally imposed capital
requirements.
2017 2016
Categories of financial instruments GBP'000 GBP'000
Financial assets: Available for sale held
at cost
Investments 1,480 1,395
Financial assets: Loans and Receivables
Investments - 36
Cash and cash equivalents 570 967
Amounts due from associates 21 -
2,071 2,398
Financial liabilities: At amortised cost
Trade and other payables 1,106 295
Loan notes 2,603 616
Financial liabilities: At fair value through
profit and loss
Equity derivatives 361 78
4,070 989
Financial risk management objectives
Management provides services to the business, co-ordinates
access to domestic and international financial markets, and
monitors and manages the financial risks relating to the operations
of the Group. These risks include foreign currency risk, credit
risk and liquidity risk. The Group does not enter into or trade
financial instruments, including derivative financial instruments,
for speculative purposes and any currency hedging transactions.
In order to effectively manage these risks, the Board of
Directors has approved strategies for the management of financial
risks, which are in line with corporate objectives. These
strategies set up guidelines for the short term and long term
objectives and action to be taken in order to manage the financial
risks that the Group faces.
The major guidelines are the following:
-- Maximise the use of "natural hedge" favouring as much as
possible the natural off-setting of costs, payables and receivables
denominated in the same currency.
-- All financial risk management activities are carried out and
monitored at a central level and discussed at
Board level.
-- The Group will not invest temporary excess liquidity in
shares or similar instruments unless authorised by the Board of
Directors.
Foreign exchange risk and foreign currency risk management
The Group is exposed to currency risk given it trades in
sterling, US dollars and Euros. While the Group aims to minimise
exposure to foreign exchange risk by matching the currency of
income and related expenditure flows where possible, fluctuations
in the exchange rate between these two currencies can have
significant effect.
Amounts Cash and
due from cash equivalent
Investments associates GBP'000 Total
Financial assets by currency: GBP'000 GBP'000 GBP'000
Currency
British pounds - - 729 729
US dollars 1,431 - 238 1,669
Balance at 31 December 2016 1,431 - 967 2,398
Currency
British pounds - - 6 6
US dollars 1,480 21 564 2,065
Balance at 31 December 2017 1,480 21 570 2,071
Trade and
other payables
Borrowings GBP'000 Total
Financial liabilities by currency: GBP'000 GBP'000
Currency
British pounds - 78 78
US dollars 694 217 911
Balance at 31 December 2016 694 295 989
Currency
British pounds - 145 145
US dollars 2,964 694 3,658
Euros - 267 267
Balance at 31 December 2017 2,964 1,106 4,070
Credit risk management
Credit risk refers to the risk that a counterparty will default
on its contractual obligations, resulting in financial loss to the
Group. The Group has minimal trade and other receivables at the
year end.
The Group makes allowances for impairment of receivables where
there is an identified event which, based on previous experience,
is evidence of a reduction in the recoverability of cash flows.
The credit risk on liquid funds (cash) is considered to be
limited because the counterparties are financial institutions with
good credit ratings assigned by international credit-rating
agencies. The carrying amount of financial assets recorded in the
financial statements represents the Group's maximum exposure to
credit risk. There are no significant concentrations of credit
risk.
The credit risk arising in respect of investments is inevitably
higher risk. The nature of the Group's business is developing
innovative solutions for the treatment of cancer and there is no
guarantee that any individual investment will be successful. This
risk is partly mitigated through representation on its Board of
Directors and the Group's CEO monitors its progress on a regular
basis.
The maximum credit risk to which the Group is exposed is
summarised in the following table.
2017 2016
GBP'000 GBP'000
Investments 1,480 1,431
Cash and cash equivalents 570 967
Amounts due from associates 21 -
Balance at 31 December 2,071 2,398
As explained in note 18, cash and cash equivalents balances
represent bank balances.
The Group does not hold collateral for any of its
receivables
There were no past due receivables.
Investments are in the form of equity investment in private
companies in which the Group is represented on its
Board of Directors and the Group's CEO monitors its progress on
a regular basis.
Liquidity risk management
Ultimate responsibility for liquidity risk management rests with
the Board of Directors, which has built an appropriate liquidity
risk management framework for the management of the Group's short,
medium and long- term funding and liquidity management
requirements. The Group manages liquidity risk by maintaining
adequate cash reserves and by continuously monitoring forecast and
actual cash flows.
The following tables analyse financial liabilities by remaining
contractual maturity.
Trade and
other payables
Financial liabilities by contractual Borrowings GBP'000 Total
maturity GBP'000 GBP'000
Less than 1 year - 295 295
1-3 years 694 - 694
Balance at 31 December 2016 694 295 989
Less than 1 year - 1,106 1,106
3-4 years 2,964 - 2,964
Balance at 31 December 2017 2,964 1,106 4,070
The Group expects to pay all liabilities at their contractual
maturity.
As a biotech group of companies at an early stage of development
and without significant internally generated cash flows, there are
inherent liquidity risks, including the possibility that additional
financing may not be available to the Group, or that actual drug
development expenditures may exceed those planned. The current
uncertainty in global markets could have an impact on the Group's
future ability to access capital on terms that are acceptable to
the Group. There can be no assurance that required financing will
be available to the Group.
22 Share capital
Authorised and issued equity share capital
2017 2016
Number Number
'000 GBP'000 '000 GBP'000
Authorised
Ordinary Shares of 2.5p each 80,000 2,000 80,000 2,000
Issued and fully paid
Ordinary Shares of 2.5p each 36,467 911 36,467 911
The parent company has one class of Ordinary Shares, which carry
no right to fixed income.
Movements during the year:
31 December 2017 31 December 2016
Number Number
'000 GBP'000 '000 GBP'000
Balance at beginning of year 36,467 911 618,493 155
Share consolidation - - (612,308) -
Issues during the year - - 5,493 136
Issued on reverse acquisition - - 24,789 620
36,467 911 36,467 911
23 Reverse acquisition reserve
The reverse acquisition reserve of GBP3,065,000 (2016:
GBP3,065,000) arose when SalvaRx Limited completed a reverse
takeover of 3 Legs Resources plc during 2016.
24 Share-based payment reserves
Share options outstanding are as follows:
SalvaRx Group plc 2017 2016
Weighted Weighted
average average
exercise exercise
Options price Options price
GBP'000 GBP'000 GBP'000 GBP'000
Outstanding at 1 January 3,226 35.74p 474 23.2p
Granted during the year - - 2,752 37.9p
Outstanding at 31 December 3,226 35.74p 3,226 35.74p
iOx Therapeutics Limited
Outstanding at 1 January 1.3 120 0.7 120
Granted during the year - - 0.6 120
Outstanding at 31 December 1.3 120 1.3 120
The parent company and its subsidiary do not operate a formal
stock option scheme, however certain options to subscribe for the
Company's or its subsidiary's shares have been granted to selected
Directors and consultants on an ad hoc basis pursuant to individual
option agreements (the 'Non-Plan Options').
(A) iOx Therapeutics Limited
Value
based
on Black-Scholes
option Graded Graded
Option pricing vesting vesting
Date of Date of price model in 2017 in 2016
grant expiry GBP Vesting terms # of Options GBP'000 GBP'000 GBP'000
25% on grant
14 Dec 14 Dec and 25% each
15 20 120 anniversary 675 57 7 23
28 Nov 28 Nov
16 21 120 vested 649 60 - 60
1,324 117 7 83
24 Share-based payment reserves (continued)
(B) SalvaRx Group plc
Value
based
on Black-Scholes
option Graded Graded
Option pricing vesting vesting
Date of Date of price model in 2017 in 2016
grant expiry GBP Vesting terms # of Options GBP'000 GBP'000 GBP'000
Apr 2015
to July 16 Feb
2015 21 0.232 Vested 431,153 - - -
16 Feb 16 Feb
15 18 0.232 Vested 43,115 - - -
Three equal
tranches
1(st) on 22
March 2017,
2(nd) on 22
March 2018
22 Mar 22 Mar 3(rd) on 22
16 21 0.355 March 2019 2,508,777 509 184 233
22 Mar 22 Mar
16 21 0.71 Vested 182,333 31 - 31
22 Mar 22 Mar
16 19 0.355 Vested 60,563 10 - 10
3,225,941 550 184 274
The fair value of the options has been calculated using the
Black Scholes model. The significant inputs into the model for the
IFRS 2 valuation were as follows:
Grants
14 December 28 November 22 March 22 March
2015 2016 2016 2016
# of Options 675 649 2,691,110 60,563
Risk free interest
rate 1% 1% 1% 1%
Expected volatility 91.60% 106.48% 92.91% 94.33%
Expected life in days 1850 1825 1825 1095
Market price GBP 120 GBP 120 GBP 0.30 GBP 0.30
25 Related party transactions
Transactions between the parent company and its subsidiaries,
which are related parties, have been eliminated on consolidation
and are not disclosed in this note.
The Group has entered into related party transactions with its
associated entities RIFT Biotherapeutics Inc. and Nekonal Oncology
Limited. Full details of these transactions are included in notes
15 and 16.
Trade and other receivables includes amounts due from associates
of GBP21,000 (2016: GBPnil). The amount is interest free and
repayable on demand.
Included in trade and other payables is amounts owing to
directors of GBP189,000 (2016: GBPnil). This relates to consulting
fees due to the directors and GBP189,000 was the maximum balance
outstanding during the year. The loans are interest fee and
repayable on demand.
On 2 March 2017 the convertible loan note liability in SalvaRx
Group plc at 31 December 2016 was transferred to SalvaRx Limited
and the note holders, J Mellon , the non- executive chairman and G
Bailey, a Non- executive Director, agreed to accept 4,000 shares of
SalvaRx limited at a price of US $250 per share in settlement of
the loan notes, this gave them 5.85% equity in SalvaRx Limited.
On the 28 February 2017 and 19 October 2017 respectively, J
Mellon, received non-convertible loan notes of US $1,000,000 and US
$500,000 in SalvaRx Limited. Details of the terms of the loan notes
are included in note 19.
On the 2 March 2017 and 19 October 2017 respectively, G Bailey,
received non-convertible loan notes of US $1,000,000 and US
$500,000 in SalvaRx Limited. Details of the terms of the loan notes
are included in note 19.
Payments to key management personnel
The remuneration of the Non-Executive Directors, Executive
Directors and senior management, who are the key management
personnel of the Group, is set out below in aggregate for each of
the categories specified in IAS 24 Related Party Disclosures.
2017 2016
GBP'000 GBP'000
Consulting fees 469 203
Share based payments 76 138
Business expenses reimbursed 5 52
550 393
26 Non-controlling interest
The group's non-controlling interests ("NCI") at 31December 2017
were:
-- iOx Therapeutics Limited ("iOx") in which the NCI is 43.05%
-- Saugatuck Therapeutics Limited ("Saug") in which the NCI is 30%, and
-- SalvaRx Limited in which the NCI is 5.85%.
The movement in NCI during the year is as follows:
GBP'000
At 1 January 2016 1,059
Loss attributable to NCI (407)
At 31 December 2016 647
Loss attributable to NCI (490)
Conversion of 2016 loan notes 148
Equity contributed to NCI on formation
of Saug 79
At 31 December 2017 384
On 2 March 2017, the non-controlling shareholders in SalvaRx
Limited accepted 4,000 shares of SalvaRx Limited at a price of
EUR250 per share in settlement of outstanding loan notes, which
gave them 5.85% equity in SalvaRx Limited. The conversion resulted
in a GBP148,000 credit to NCI reflecting the benefit of the
conversion and the NCI gaining a 5.85% share in the net assets of
SalvaRx Limited.
Summarised financial information in respect of each material
subsidiary undertaking with a non-controlling interest and prior to
the elimination of intra-group items is set out below.
2017 2016*
SalvaRx Limited GBP'000 GBP'000
Non-current assets 5,020 -
Current assets 767 -
Current liabilities (2,098) -
Non-current liabilities (2,968) -
721 -
2017 2016*
GBP'000 GBP'000
Revenue - -
Loss for the year (814) -
* - Comparative balances have not been provided because
non-controlling interests in SalvaRx Limited of 5.85% only arose
from 2 March 2017.
2017 2016
iOx Therapeutics Limited GBP'000 GBP'000
Non-current assets - -
Current assets 534 1,189
Current liabilities (579) (417)
Non-current liabilities - -
(45) 772
2017 2016
GBP'000 GBP'000
Revenue - -
Loss for the year (865) (879)
27 Events after the balance sheet date
On 8 March 2018 iOx Therapeutics Limited issued US$1m of
unsecured convertible loan notes. The notes entitle the holder to
interest of 7% per annum and are convertible into ordinary shares
in iOx on the earlier of the first anniversary of the date of issue
of the instrument or the date in which iOx conducts a sale or
listing or it undertakes an eligible third-party fundraising of not
less than $2m.
On 26 June 2018, J Mellon and G Bailey made additional loans to
the company of US$500,000 each. Interest is payable on the loans at
7% per annum and the loans are repayable on 20 June 2019.
28 Contingent liabilities
SalavRx Limited has entered an agreement with RIFT
Biotherapeutics Inc under which it is obliged to make further
investment of $650,000 in the company subject to certain
development milestones being achieved. As the directors currently
consider the achievement of the development milestones to be
possible but not certain this obligation is considered a contingent
liability, as set out in note 15.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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