TIDMTILS
RNS Number : 1251L
Tiziana Life Sciences PLC
29 September 2016
Tiziana Life Sciences plc
("Tiziana" or "the Company")
Interim Results for the Six Months Ended 30 June 2016
Advancing pipeline of next generation therapeutics and
diagnostics for oncology and immune diseases of high unmet need
London, 29 September 2016 - Tiziana Life Sciences plc
("Tiziana", AIM: TILS), the research and clinical stage
biotechnology company focussing on proprietary drug candidates to
treat cancer and autoimmune diseases, today announces its interim
results for the six months ended 30 June 2016.
Highlights during the period:
LEADERSHIP
-- The Company significantly enhanced its commercial and
clinical development strength with the addition of highly
experienced executives to its senior leadership team and Scientific
Advisory Board:
- Dr. Robert Evans joined as Vice President of Clinical
Sciences, formerly VP of Clinical Development at Glenmark
Pharmaceuticals, Inc.
- Tiziano Lazzaretti appointed as Chief Financial Officer,
formerly Group Finance Director at Pharmentis.
- Professors Kevan Herold and Howard Weiner joined Scientific
Advisory Board, providing key leadership and experience in CD3
clinical development.
RESEARCH & DEVELOPMENT
Foralumab
-- Initial evaluation of foralumab in two clinical indications:
graft vs host disease and non-alcoholic steatohepatitis (NASH).
Milciclib
-- Continuing in Phase II trials for thymic carcinoma (thymoma)
in patients previously treated with chemotherapy.
TZLS-101 / Bcl-3 Inhibitor
-- Research agreement with Cardiff University, focused on
pioneering the development of Bcl-3 inhibitors as potential drugs
to treat cancer, has led to the identification of a first-in-class
lead clinical candidate, CB1, with potent anti-metastatic activity,
and with an impressive in vivo efficacy and safety profile.
-- This partnership was recognised as the winner of the
Innovation in Healthcare category at Cardiff University's
Innovation and Impact Awards 2016.
-- Tiziana intends to file an Investigational New Drug (IND)
application for CB1 in June 2017 and expects to move this drug
candidate into clinical trials shortly thereafter.
TZLS-214 / c-FLIP
-- Currently under analysis, a lead candidate is expected to be disclosed later this year.
StemPrinter
-- Currently under analysis with more details expected later this year.
FINANCIAL
-- GBP0.68m (gross) raised through a convertible loan note in January 2016.
-- For the six months to 30 June 2016 the consolidated Group
made a loss of GBP2.11m (six months to 30 June 2015: GBP4.11m).
-- The Group ended the period with GBP8.28m cash as at 30 June 2016 (31 Dec 2015: GBP8.90m).
Highlights post period:
-- In July Tiziana acquired a unique bio-repository of local
samples and data from Sardinian company Shardna SpA.
- Residents of Sardinia are among the world's longest living
people, with on average 5x greater likelihood of reaching age 100
compared with the USA.
- LonGevia Genomics Srl, a regional subsidiary, has been
established specifically to develop these assets to identify novel
drug targets and diagnostic applications.
"Tiziana Life Sciences has had a successful six months,"
commented Gabriele Cerrone, Chairman and founder, "We have built on
our strong close to last year and the funds raised have enabled us
to significantly bolster our pipeline, which now addresses several
areas of significant unmet medical need in both cancer and
autoimmune diseases. Our award-recognised partnership with Cardiff
University is advancing new approaches, such as the inhibition of
metastasis, to treat life-threatening cancers. Looking ahead, we
are confident of being well positioned to progress these programmes
to their next respective value inflection points."
Contacts:
Tiziana Life Sciences plc
Gabriele Cerrone, Chairman
and founder +44 (0)20 7493 2853
Cairn Financial Advisers
LLP (Nominated adviser)
Liam Murray / Jo Turner +44 (0)20 7148 7900
Beaufort Securities Limited
(Broker)
Saif Janjua +44 (0)20 7382 8300
FTI Consulting
Simon Conway / Natalie Garland-Collins +44 (0)20 3727 1000
About Tiziana Life Sciences
Tiziana Life Sciences plc is a UK biotechnology company that
focuses on the discovery and development of novel drug candidates
for treatment of cancer and autoimmune diseases in humans:
In May 2015, the Company exclusively licenced a novel
anti-cancer stem cell agent, c-FLIP, capable of targeting
aggressive tumour forming cells originating from the breast,
pancreas, colon and prostate.
In January 2015, the Company exclusively licenced milciclib, a
small molecule drug candidate, which blocks the action of specific
enzymes called cyclin-dependent kinases (CDK) involved in cell
division as well as a number of other protein kinases. Milciclib is
currently in phase II clinical trials for thymic carcinoma
(thymoma) in patients previously treated with chemotherapy.
The Company also in-licensed another clinical asset foralumab in
December 2014 from Novimmune. Foralumab is currently the only fully
human engineered anti-human CD3 antibody in clinical development.
This phase II asset has potential applications in a wide range of
autoimmune and inflammatory diseases, such as NASH, GVHD, multiple
sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD),
psoriasis and rheumatoid arthritis, where modulation of a T-cell
response is desirable.
Tiziana Life Sciences' research team has discovered that Bcl-3
has a prominent role in the metastasis of mammary cancers, and has
elucidated the mechanism of Bcl-3 action to be a regulator of
cancer cell motility. Tiziana has also determined that Bcl-3
inhibition suppresses cell motility in triple-negative and other
breast cancer sub-types, suggesting that Bcl-3 may be a master
regulator of this metastatic property not only in aggressive breast
cancers, but across the clinical spectrum of breast disease. Triple
negative breast cancer (testing negative for estrogen receptors
(ER-), progesterone receptors (PR-), and HER2 (HER2-), is an unmet
medical needs with high mortality rates. Metastatic spreading of
the cancer is the single most important cause of the high
mortality. Our technology with drug candidate inhibiting
specifically Bcl-3 is an innovative approach to suppress growth of
metastases.
EXECUTIVE CHAIRMAN'S STATEMENT
I am pleased to report on the Group's financial results for the
six months ended 30 June 2016.
Background
Tiziana Pharma Ltd (TPL), Tiziana Life Sciences plc's operating
subsidiary, was established in November 2013 with the aim of
developing novel therapeutics for cancer with a focus on late stage
metastases. TPL, founded on research from the European Cancer Stem
Cell Institute, University of Cardiff, identified the B-cell
Lymphoma 3 (Bcl-3) gene as a potential drug target to halt cancer
metastasis, where malignant tumours spread to other parts of the
body, a process typically associated with poor patient prognosis.
TPL entered into an agreement with the European Cancer Stem Cell
Institute for the exclusive worldwide license to any compound with
potential therapeutic application against Bcl-3.
On 24 April 2014 Tiziana Life Sciences plc (the Company;
Tiziana) began trading on AIM under the ticker symbol "TILS"
following the completion of the reverse acquisition of Alexander
David Investments plc and concurrent name change to Tiziana Life
Sciences plc. The Company issued 16,666,667 ordinary shares at a
price of 12p through a placing to new investors raising GBP2m and a
convertible loan note raising GBP0.73m to complete the reverse
acquisition.
Tiziana Therapeutics Inc, Tiziana Life Sciences plc's US
operating subsidiary, was established in October 2015 with the aim
of managing the Company's global clinical programmes.
Financial summary
The Group has made a loss for the six months to 30 June 2016 of
GBP2.11m (six months to 30 June 2015: GBP4.11m). The loss is
detailed in the consolidated statement of comprehensive income.
The Group ended the period with GBP8.28m cash as at 30 June 2016
(31 Dec 2015: GBP8.90m).
Fund raising
In January 2016, Tiziana entered into an agreement to issue
GBP676,241 of Convertible Equity Instruments.
Funds raised by Tiziana will be used to fund the development of
the Group's clinical stage assets milciclib and foralumab, to meet
the Group's ongoing liabilities in respect of license agreements,
and for general working capital purposes.
Research & Development
In January 2016, the Company announced that its research
agreement with Cardiff University, focused on pioneering the
development of Bcl-3 inhibitors as potential drugs to treat cancer,
has led to the identification of a first-in-class lead clinical
candidate, CB1 (TZLS-101), with potent anti-metastatic activity,
and with an impressive in vivo efficacy and safety profile. This
partnership was recognised as the winner of the Innovation in
Healthcare category at Cardiff University's Innovation and Impact
Awards 2016. Tiziana intends to file an Investigational New Drug
(IND) application for CB1 in June 2017, and expects to move this
drug candidate into clinical trials shortly thereafter.
Also in January 2016 Tiziana outlined its clinical development
plan for foralumab with initial plans to evaluate foralumab in two
clinical indications; namely, graft vs host disease and
non-alcoholic steatohepatitis (NASH). Foralumab is the only fully
human anti-CD3 monoclonal antibody currently in development for the
modulation of autoimmune disease.
The Company's small molecule drug candidate, milciclib,
continues to progress through Phase II trials for thymic carcinoma
(thymoma) in patients previously treated with chemotherapy.
Tiziana's novel anti-cancer stem cell agent, TZLS-214 / c-FLIP
is currently under analysis, a lead candidate is expected to be
disclosed later this year. StemPrinter is also currently under
analysis with more detailed expected later this year.
Post period in July 2016, Tiziana acquired a unique
bio-repository of local samples and data from Sardinian company
Shardna SpA. Residents of Sardinia are among the world's longest
living people, with on average five times greater likelihood of
reaching age 100 compared with the USA. The Company has established
LonGevia Genomics Srl, a regional subsidiary specifically to
develop these assets to identify novel drug targets and diagnostic
applications through leveraging next generation gene sequencing and
state of the art "-omics" technologies.
Appointments
On 4 April 2016, Tiziano Lazzaretti was appointed as Chief
Financial Officer, taking over from Phil Boyd, who tendered his
resignation on 7th May 2015 in order to focus on other
opportunities.
Mr Lazzaretti has extensive experience in the healthcare and
pharmaceutical industry and joins Tiziana from Pharmentis Srl, an
Italian pharmaceutical business, where he served as Group Finance
Director since 2011. Prior to this, Mr Lazzaretti held senior roles
at Alliance Boots Healthcare, Accenture and other listed companies
such as SNIA Spa and Fiat Group. He has a Bachelor of Science (BSc
hons) in Accounting and Finance from the University of Turin, Italy
and was awarded a Master in Business Administration (MBA) from
Bocconi University, Milan.
Also on 4 May 2016, Tiziana expanded its clinical development
team with the appointment of Robert Evans, PharmD. as Vice
President of Clinical Sciences. Dr. Evans joined Tiziana Life
Sciences in April 2016 as Vice President of Clinical Sciences.
Prior to joining the Company, Dr. Evans served as Vice President of
Clinical Development at Glenmark Pharmaceuticals, Inc. and was
responsible for providing project and clinical leadership across
multiple programs focused on the treatment of oncology, respiratory
and dermatology disorders. Prior to Glenmark, Dr. Evans served in
scientific leadership roles in the Immunology and Inflammation
Group at Regeneron Pharmaceutical.
On 11 January 2016, the Company announced the addition of two
key members to the Scientific Advisory Board: Professors Kevan
Herold, MD and Howard Weiner, MD.
Dr. Kevan Herold
Dr. Kevan Herold is Professor of Immunobiology and of Medicine
(Endocrinology) as well as Deputy Director, Yale Center for
Clinical Investigation, Director of the Yale Diabetes Center and
Director of the TrialNet Center at Yale. His investigative work has
focused on developing new ways to prevent and treat autoimmune
diseases, using novel translational immunologic and metabolic
approaches to prevent progression, in particular anti-CD3
monoclonal antibody therapy. His clinical interests are in the
management of endocrine diseases, and he is involved in a number of
national and international clinical studies of new treatments.
Dr. Howard Weiner
Dr. Howard Weiner is the Robert L. Kroc Professor of Neurology
at the Harvard Medical School, Director and Founder of the Partners
Multiple Sclerosis (MS) Center and Co-Director of the Ann Romney
Center for Neurologic Diseases at Brigham & Women's Hospital in
Boston. The Partners MS Center is the first integrated MS Center
that combines clinical care, MRI imaging and immune monitoring to
the MS patient as part of the 2000 patient CLIMB cohort study. He
has pioneered immunotherapy in MS and has investigated immune
mechanisms in nervous system diseases including MS, Alzheimer's
disease, amyotrophic lateral sclerosis, stroke and brain tumours.
He has also pioneered the investigation of the mucosal immune
system for the treatment of autoimmune and other diseases and the
use of anti-CD3 to induce regulatory T cells for the treatment of
these diseases.
Outlook
It has been a busy six months for the Company as we have
bolstered our senior leadership team and Scientific Advisory Board,
and continued to progress our pipeline of drugs to treat rare
cancers and difficult to treat autoimmune inflammatory
diseases.
We have outlined our clinical development plan for foralumab
with initial plans to evaluate foralumab in two clinical
indications: graft vs host disease and NASH.
Also, our award-recognised partnership with Cardiff University
is advancing new approaches, such as the inhibition of metastasis
using Bcl-3 inhibitors, to treat life-threatening cancers.
Looking forward, we are confident of being well positioned to
progress these programmes to their next respective value inflection
points.
Gabriele Cerrone
Executive Chairman
Consolidated Statement of Comprehensive
Income
for the six months ended 30 June
2016
6 months 6 months 12 months
to 30 to 30 to 31
June June Dec
2016 2015 2015
GBP'000 GBP'000 GBP'000
Notes (unaudited) (unaudited)
------------ ------------ ----------
Research and development (727) (2,738) (6,287)
Operating expenses 3 (1,387) (1,164) (2,327)
Operating loss (2,114) (3,902) (8,614)
Financial income 3 12 1 1
Financial expense 3 (4) (210) (19)
Operating loss before
taxation (2,106) (4,111) (8,632)
Tax expense -- -- --
Operating loss after
taxation (2,106) (4,111) (8,362)
Net loss for the period
attributable to equity
owners (2,106) (4,111) (8,632)
Other comprehensive -- -- --
income for the period
Total comprehensive
loss attributable to
equity owners (2,106) (4,111) (8,632)
============ ============ ==========
Basic and diluted loss
per share (pence)
Basic and diluted loss
per share on continuing
operations 4 (2.3p) (4.6p) (9.5p)
============ ============ ==========
Total basic and diluted
loss per share (2.3p) (4.6p) (9.5p)
============ ============ ==========
Consolidated Statement
of Financial Position
as at 30 June 2016
30 June 30 June 31 Dec
2016 2015 2015
GBP'000 GBP'000 GBP'000
Notes (unaudited) (unaudited)
------------ ------------ -----------
Assets
Current assets:
Trade and other receivables 5 99 168 347
Cash and cash equivalents 8,281 6,959 8,903
------------ ------------ -----------
Total current assets 8,380 7,127 9,250
Total assets 8,380 7,127 9,250
============ ============ ===========
Equity and liabilities
Shareholders' equity
Called up share capital 6 9,435 9,374 9,375
Share premium 21,025 18,742 20,632
Share based payment
reserve 7 1,054 503 1,008
Shares to be issued
reserve 7 150 205 102
Convertible loan note
reserve 8 13,121 7,835 12,287
Merger relief reserve 5,625 5,625 5,625
Other reserve (28,286) (28,286) (28,286)
Retained earnings 9 (14,653) (7,628) (12,239)
Equity attributed
to the owners of the
Company 7,471 6,370 8,504
Current liabilities:
Trade and other payables 10 909 757 746
------------ ------------ -----------
909 757 746
Total Equity and Liabilities 8,380 7,127 9,250
============ ============ ===========
Consolidated Statement
of Cash Flows
for the six months ended
30 June 2016
6 months 6 months 12 months
to to to 31
30 June 30 June Dec
2016 2015 2015
GBP'000 GBP'000 GBP'000
(unaudited) (unaudited)
------------ ------------ ----------
Cash flows from operating
activities
Total comprehensive loss
for the period before
tax (2,106) (4,111) (8,632)
Convertible loan interest -- 113 --
accrued
Convertible loan interest
paid as equity 4 4 --
Share based payment -
options 46 401 972
Other share based payments -- -- 2,138
Net (increase) / decrease
in operating assets
-Trade / other receivables 248 26 (153)
Net increase / (decrease)
in operating liabilities
-Trade / other liabilities 163 (181) 63
------------ ------------ ----------
Net cash used in operating
activities
Cash flow from financing
activities
Proceeds from issuance
of ordinary shares (1,583) (3,543) (5,510)
Proceeds from issuance
of convertible loan notes
Fundraising costs 285 2,678 2,638
Interest on convertible 676 5,671 10,235
instruments -- -- (726)
Net cash generated from -- (113) --
financing activities
961 8,236 12,147
Net increase / (decrease)
in cash and cash equivalents (622) 4,693 6,637
Cash and cash equivalents
at beginning of period 8,903 2,266 2,266
Cash and cash equivalents
at end of period 8,281 6,959 8,903
------------ ------------ ----------
Consolidated Statement of Changes in Equity
for the six month period to 30 June 2016
Share Shares
Based to Convertible
Share Share Payment Be Loan Merger Other Retained Total
(Unaudited) Capital Premium Reserve Issued Note Reserve Reserve Earnings Equity
Reserve Reserve
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
Balance at
1 January
2016 9,375 20,632 1,008 102 12,287 5,625 (28,286) (12,239) 8,504
Transactions
with owners
Issue of share
capital
Share based
payment (options) 60 393 - - - - - - 453
- - 46 - - - - - 46
Share based
payment (warrants) - - - 48 - - - - 48
- - - - 834 - - (308) 526
Convertible
loan note
- equity component
Total transactions
with owners 60 393 46 48 834 - - (308) 1,073
Comprehensive
income
Loss for the
period - - - - - - - (2,106) (2,106)
Total comprehensive
income - - - - - - - (2,106) (2,106)
Balance at
30 June 2016 9,435 21,025 1,054 150 13,121 5,625 (28,286) (14,653) 7,471
--------- ------------ -------- -------- ------------- --------- --------- ---------- --------
Balance at
1 January
2015 9,144 16,294 146 -- 2,259 5,625 (28,286) (3,405) 1,777
Transactions
with owners
Issue of share
capital 230 2,448 - - - - - - 2,678
Share based
payment (options) - - 401 - - - - - 401
Share based
payment (warrants) - - - 205 - - - - 205
Convertible
loan note
- equity component - - - - 6,258 - - (112) 6,146
Associated
transaction
costs - - (44) - (682) - - - (726)
Total transactions
with owners 230 2,448 357 205 5,576 - - (112) 8,704
Comprehensive
income
Loss for the
period - - - - - - - (4,111) (4,111)
Total comprehensive
income - - - - - - - (4,111) (4,111)
Balance at
30 June 2015 9,374 18,742 503 205 7,835 5,625 (28,286) (7,628) 6,370
--------- ------------ -------- -------- ------------- --------- --------- ---------- --------
Share Shares
Based To Convertible
Share Share Payment Be Loan Merger Other Retained Total
Capital Premium Reserve Issued Note Reserve Reserve Earnings Equity
Reserve Reserve
Balance at
1 January
2015 9,144 16,294 146 -- 2,259 5,625 (28,286) (3,405) 1,777
Transactions
with owners
Issue of
share
capital 231 4,338 - - - - - - 4,569
Share based
payment
(options) - - 972 - - - - - 972
Share based
payment
(warrants) - - - 102 - - - - 102
Convertible
loan note
- equity
component - - - - 10,028 - - (312) 9,716
Options
cancelled
in the year - - (110) - - - - 110 -
Total
transactions
with owners 231 4,338 862 102 10,028 - - (202) 15,359
Comprehensive
income
Loss for the
period - - - - - - - (8,632) (8,632)
Total
comprehensive
income - - - - - - - (8,632) (8,632)
Balance at
31 December
2015 9,375 20,632 1,008 102 12,287 5,625 (28,286) (12,239) 8,504
--------- --------- -------- --------- ------------- --------- --------- ---------- ---------
Notes to the Interim Financial Statements
for the six month period to 30 June 2016
1. GENERAL INFORMATION
Tiziana Life Sciences PLC is a public limited company
incorporated in the United Kingdom under the Companies Act and
quoted on the AIM market of the London Stock Exchange (AIM: TILS).
The address of its registered office is 3rd Floor 11-12 St. James's
Square, London, United Kingdom, SW1Y 4LB. The principal activities
of the Company and its subsidiaries (the Group) are that of a
clinical stage biotechnology company focussed on targeted drugs to
treat diseases in oncology and immunology.
These consolidated interim financial statements are presented in
pounds sterling because that is the functional currency of the
primary economic environment in which the Group operates.
The ultimate parent of the Group is Planwise Group Limited,
incorporated in the British Virgin Islands. Gabriele Cerrone is the
ultimate beneficial owner of the entire issued share capital of
Planwise Group Limited.
2. Accounting policies
The accounting policies applied and adopted are consistent with
those followed in the preparation of the Group's audited financial
statements for the year ended 31 December 2015. None of the newly
applicable IFRS standards and amendments had an impact on the
Group's interim consolidated financial information.
Some of the significant accounting policies require management
to make difficult, subjective or complex judgments or estimates.
The policies which management consider critical because of the
level of complexity, judgment or estimation involved in their
application and their impact on the financial information are;
-- Basis of consolidation (reverse acquisition)
-- Convertible loan notes
-- Share based payments
Basis of preparation
The consolidated financial statements of the Group have been
prepared in accordance with the International Financial Reporting
Standards (IFRS) as adopted by the European Union, IFRIC
interpretations and the Companies Act 2006 as applicable to
companies reporting under IFRS. These accounts have been prepared
under the historical cost convention, as modified by the
revaluation of land and buildings and certain financial
instruments.
The condensed interim financial information contained in this
interim statement does not constitute financial statements as
defined by section 434(3) of the Companies Act 2006. The condensed
interim financial information has been neither audited nor reviewed
by the Group's auditors. The financial information for the period
ended 30 June 2016 is taken from the current management accounts.
The comparative financial information for the year ended 31
December 2015 is taken from the statutory accounts. The comparative
information for the period ended 30 June 2015 is taken from last
year's interim results (the equity opening balances have been
restated as per the 2015 statutory accounts).
There are no additional standards or interpretations applicable
to the Group for the accounting period commencing 1 January 2016
for adoption.
In preparing the condensed interim financial information the
Directors have considered the Group's financial projections,
borrowing facilities and other relevant financial matters, and the
Board is satisfied that there is a reasonable expectation that the
Group has adequate resources to continue in operational existence
for the foreseeable future. For this reason, the Directors continue
to adopt the going concern basis in preparing the financial
information.
Basis of consolidation
Subsidiary undertakings are all entities over which the Group
has the power to govern the financial and operating policies of the
subsidiary and therefore exercises control. The existence and
effect of both current voting rights and potential voting rights
that are currently exercisable or convertible are considered when
assessing whether control of an entity is exercised. Subsidiaries
are consolidated from the date at which the Group obtains the
relevant level of control and are de-consolidated from the date at
which control ceases.
Tiziana Therapeutics Inc was incorporated on the 28(th) of
October 2015. The management accounts for the first six months have
been included in the consolidated Group's numbers.
Inter-company transactions, balances and unrealised gains on
transactions between Group companies are eliminated upon
consolidation. Unrealised losses are also eliminated. Accounting
policies of subsidiaries have been changed where necessary to
ensure consistency with the policies adopted by the Group.
Fair value measurement
Management have assessed the categorisation of the fair value
measurements using the IFRS 13 fair value hierarchy. Categorisation
within the hierarchy has been determined on the basis of the lowest
level of input that is significant to the fair value measurement of
the relevant asset as follows;
-- Level 1 - valued using quoted prices in active markets for identical assets;
-- Level 2 - valued by reference to valuation techniques using
observable inputs other than quoted prices included within Level
1;
-- Level 3 - valued by reference to valuation techniques using
inputs that are not based on observable market data.
Convertible loan notes
Under IAS 32 the liability and equity components of convertible
loan notes must be presented separately on the Statement of
Financial Position. The Group has examined the terms of each issue
of convertible loan notes and determined their accounting treatment
accordingly. Convertible loan notes are treated differently
depending upon a number of factors.
Where there is an option to repay the loan note as equity or
cash
The Group considers these to be Convertible Loan Instruments and
estimates the fair value consideration in respect of the liability.
The Group carries out an assessment to determine the fair value of
a similar liability that does not have any associated equity
conversion option. The interest rate of a similar liability is
estimated by the Group in order to evaluate the fair value of the
liability and the resulting equity component.
Convertible loans are accounted for as compound instruments. The
fair value of the liability portion of the convertible loan notes
is determined using a market interest rate for an equivalent
nonconvertible loan note. This amount is recorded as a liability on
an amortised cost basis until extinguished on conversion or
maturity of the loan notes. The remainder of the proceeds is
allocated to the conversion option, which is recognised and
included in shareholders' equity, net of tax effects, and is not
subsequently re-measured.
Where there is no option to repay as cash and the interest rate
is fixed
The Group considers these to be Convertible Equity Instruments
and records the principal of the loan note as an equity liability
in a shares to be issued reserve. The accrued interest on the
principal amount is also recorded in the shares to be issued
reserve. Upon redemption of the instrument and the issue of share
capital, the amount is reclassified from the shares to be issued
reserve to share capital and share premium.
Where there is no option to repay as cash and the interest rate
is variable
The Group considers these to be Convertible Debt Instruments and
records the principal of the loan note as a debt liability in the
liabilities section of the Statement of financial position. The
accrued interest on the principal amount is recorded in the
Statement of comprehensive income and as an increase in the debt
liability. Upon redemption of the instrument and the issue of share
capital, the amount is reclassified from the debt liability to
share capital and share premium.
Share based payments
The calculation of the fair value of equity-settled share based
awards and the resulting charge to the statement of comprehensive
income requires assumptions to be made regarding future events and
market conditions. These assumptions include the future volatility
of the Company's share price. These assumptions are then applied to
a recognised valuation model in order to calculate the fair value
of the awards.
Where employees, directors or advisers are rewarded using share
based payments, the fair value of the employees', directors' or
advisers' services are determined by reference to the fair value of
the share options / warrants awarded. Their value is appraised at
the date of grant and excludes the impact of any nonmarket vesting
conditions (for example, profitability and sales growth targets).
Warrants issued in association with the issue of Convertible Loan
Notes are also considered as share based payments and a share based
payment charge is calculated for these too.
In accordance with IFRS 2, a charge is made to the Statement of
Comprehensive Income for all share-based payments including share
options based upon the fair value of the instrument used. A
corresponding credit is made to a Share Based Payment Reserve, in
the case of options / warrants awarded to employees, directors or
advisers, and Shares To Be Issued Reserve in the case of warrants
issued in association with the issue of Convertible Loan Notes, net
of deferred tax where applicable.
If vesting periods or other vesting conditions apply, the
expense is allocated over the vesting period, based on the best
available estimate of the number of share options / warrants
expected to vest. Nonmarket vesting conditions are included in
assumptions about the number of options / warrants that are
expected to become exercisable.
Estimates are subsequently revised, if there is any indication
that the number of share options / warrants expected to vest
differs from previous estimates. No adjustment is made to the
expense or share issue cost recognised in prior periods if fewer
share options ultimately are exercised than originally
estimated.
Upon exercise of share options / warrants, the proceeds received
are allocated to share capital with any excess being recorded as
share premium.
Where share options are cancelled, this is treated as an
acceleration of the vesting period of the options. The amount that
otherwise would have been recognised for services received over the
remainder of the vesting period is recognised immediately within
the Statement of Comprehensive Income.
All goods and services received in exchange for the grant of any
share based payment are measured at their fair value.
Cash and cash equivalents
Cash and cash equivalents comprise cash at bank and in hand and
other short term highly liquid deposits with original maturities of
three months or less. Bank overdrafts are shown within borrowings
in current liabilities on the balance sheet.
3. Operating and financial expenses
Operating costs of the Group for the half-year includes GBP579k
of professional fees (2015: GBP361k). Other overheads continue to
remain at an acceptable level.
4. Earnings per share
Basic earnings per share is calculated by dividing the loss
attributable to equity holders of the Group by the weighted average
number of ordinary shares in issue during the year.
6 months 6 months 12 months
to to to
30 June 30 June 31 Dec
2015 2015 2015
(unaudited) (unaudited)
------------ ------------ -----------
Total comprehensive loss
for the period (GBP'000) (2,106) (4,111) (8,632)
Basic and diluted weighted
average number of shares 92,782,184 88,933,928 91,242,884
Basic and diluted loss
per share - pence (2.3) (4.6) (9.5)
As the Group is reporting a loss from continuing operations for
the period then, in accordance with IAS 33, the share options are
not considered dilutive because the exercise of the share options
would have an anti-dilutive effect. The basic and diluted earnings
per share as presented on the face of the Statement of
comprehensive income are therefore identical. All earnings per
share figures presented above arise from continuing and total
operations and therefore no earnings per share for discontinued
operations are presented.
5. Trade and other receivables
(unaudited) (unaudited)
30 June 30 June 31 Dec
2016 2015 2015
GBP'000 GBP'000 GBP'000
------------ ------------ --------
Trade and other receivables 88 139 273
Prepayments 11 29 74
------------ ------------ --------
99 168 347
6. Called up share capital
During the period to 30 June 2016, 1,301,250 shares were issued
to warrant holders who exercised their warrants previously granted
as an arrangement fee for subscribing to a convertible loan notes.
An additional 700,000 shares were issued to convertible loan note
holders who converted the principal and interest amount into
ordinary shares.
(unaudited)
30 June
2016
GBP'000
------------
Opening balance 9,375
Warrants exercised during the period 39
Convertible Loan Notes converted 21
9,435
============
7. Share based payments
Options
The Group operates share-based payment arrangements to
remunerate directors and key employees in the form of a share
option scheme. The exercise price of the option is normally equal
to the market price of an ordinary share in the Company at the date
of grant.
On 24 April 2014, 4,787,500 share options were granted at an
exercise price of GBP0.15 per share and are exercisable for a
period of 10 years from the date of vesting.
On 25 June 2014, a total of 385,000 share options were granted
at range of exercise prices from GBP0.28 to GBP0.33 per share and
are exercisable for a period of 10 years from the date of
vesting.
On 7 July 2014 50,000 share options were granted at an exercise
price of GBP0.35 per share and are exercisable for a period of 10
years from the date of vesting.
On 23 January 2015 2,050,000 options were granted at an exercise
price of GBP0.35 per share and are exercisable for a period of 10
years from the date of vesting.
On 23 January 2015 600,000 options were granted at an exercise
price of GBP0.50 per share and are exercisable for a period of 10
years from the date of vesting.
On 23 January 2015 300,000 options were granted at an exercise
price of GBP0.57 per share and are exercisable for a period of 10
years from the date of vesting.
On 2 March 2015 600,000 options were granted at an exercise
price of GBP0.55 per share and are exercisable for a period of 10
years from the date of vesting.
On 7 May 2015 1,237,500 options were cancelled at exercise
prices of GBP0.15 and GBP0.35 per share and would have been
exercisable for a period of 10 years from the date of vesting.
On 7 May 2015 150,000 options were granted at an exercise price
of GBP0.15 per share and are exercisable before 31st January
2018.
On 23 March 2016 400,000 options were granted at an exercise
price of GBP1.26 per share and are exercisable before 23rd March
2026.
On 9 June 2016 105,000 options were granted at an exercise price
of GBP1.50 per share and are exercisable for a period of 10 years
from the date of vesting.
On 9 June 2016 3,259,403 options were granted at an exercise
price of GBP1.50 per share and are exercisable with special
conditions for a period of 15 years from the date of vesting.
No options were exercised during the period to 30 June 2016.
28,000 options were exercised during the year to 31st December
2015.
Share options outstanding at the end of the period have the
following expiry date and exercise prices:
Date of Number at Exercise Date from which Expiry
issue 30 June 2016 price exercisable Date
24 April 24 April
2014 962,500 0.15 24 April 2015 2025
24 April 24 April
2014 962,500 0.15 24 April 2016 2026
24 April 24 April
2014 962,500 0.15 24 April 2017 2027
24 April 24 April
2014 962,500 0.15 24 April 2018 2028
25 June 17 May
2014 90,000 0.28 17 May 2015 2025
25 June 17 May
2014 90,000 0.28 17 May 2016 2026
25 June 17 May
2014 90,000 0.28 17 May 2017 2027
25 June 17 May
2014 90,000 0.28 17 May 2018 2028
25 June 24 April
2014 6,250 0.33 24 April 2015 2025
25 June 24 April
2014 6,250 0.33 24 April 2016 2026
25 June 24 April
2014 6,250 0.33 24 April 2017 2027
25 June 24 April
2014 6,250 0.33 24 April 2018 2028
07 July 18 June
2014 12,500 0.35 18 June 2015 2025
07 July 18 June
2014 12,500 0.35 18 June 2016 2026
07 July 18 June
2014 12,500 0.35 18 June 2017 2027
07 July 18 June
2014 12,500 0.35 18 June 2018 2028
23 January 23 January
2015 2,050,000 0.35 23 January 2015 2025
23 January 1 October
2015 150,000 0.5 1 October 2015 2025
23 January 1 October
2015 150,000 0.5 1 October 2016 2026
23 January 1 October
2015 150,000 0.5 1 October 2017 2027
23 January 1 October
2015 150,000 0.5 1 October 2018 2028
23 January 12 September 12 September
2015 75,000 0.57 2015 2025
23 January 12 September 12 September
2015 75,000 0.57 2016 2026
23 January 12 September 12 September
2015 75,000 0.57 2017 2027
23 January 12 September 12 September
2015 75,000 0.57 2018 2028
02 March 2 March
2015 150,000 0.55 2 March 2015 2025
02 March 2 March
2015 150,000 0.55 2 March 2016 2026
02 March 2 March
2015 150,000 0.55 2 March 2017 2027
02 March 2 March
2015 150,000 0.55 2 March 2018 2028
07 May 31 January
2015 150,000 0.15 24 April 2015 2018
23 March 22 March
2016 100,000 1.26 23 March 2017 2026
23 March 22 March
2016 100,000 1.26 23 March 2018 2026
23 March 22 March
2016 100,000 1.26 23 March 2019 2026
23 March 22 March
2016 100,000 1.26 23 March 2020 2026
09 June 09 June
2016 26,250 1.50 09 June 2017 2027
09 June 09 June
2016 26,250 1.50 09 June 2018 2028
09 June 09 June
2016 26,250 1.50 09 June 2019 2029
09 June 09 June
2016 26,250 1.50 09 June 2020 2030
If weighted
average of an
ordinary share
is greater than
GBP3 for 120 15 years
09 June consecutive from vesting
2016 3,259,403 1.50 dealing days date
The Directors have used the Black-Scholes option pricing model
to estimate the fair value of the options applying the assumptions
below. The share based payment charge to the Statement of
comprehensive income for the period is GBP46k (2015: GBP972k).
24 April 25 June 7 July 2014
2014 2014
------------- ------------- ---------------
Grant date share price GBP0.12 GBP0.39 GBP0.44
Exercise share price GBP0.15 GBP0.28 GBP0.35
to GBP0.33
Vesting periods 25% each 25% each 25% each
Yr 1, Yr Yr 1, Yr Yr 1, Yr 2,
2, Yr 3, 2, Yr 3, Yr 3, Yr 4
Yr 4 Yr 4
Risk free rate 0.55% to 0.55% to 0.55% to 1.54%
1.54% 1.54%
Expected volatility 99% to 197% 99% to 197% 99% to 197%
Option life 10 years 10 years 10 years
23 January 2 March 7 May 2015
2015 2015
----------------- ------------- ---------------
Grant date share price GBP0.575 GBP0.615 GBP0.465
Exercise share price GBP0.35 to GBP0.28 GBP0.15
GBP0.57 to GBP0.33
Vesting periods 900,000, 25% each immediate
25% each
2.05m, immediate Yr 1, Yr
2, Yr 3,
Yr 4
Risk free rate 0.55% to 0.55% to 0.55% to 1.54%
1.54% 1.54%
Expected volatility 99% to 197% 99% to 197% 99% to 197%
Option life 10 years 10 years 10 years
23 March 9 June 2016
2016
------------- --------------
Grant date share price GBP1.26 GBP1.38
Exercise share price GBP1.26 GBP1.50
Vesting periods 25% each Immediate,25%
each
Yr 1, Yr Yr 1, Yr
2, Yr 3, 2, Yr 3,
Yr 4 Yr 4
Risk free rate 0.55% to 0.55% to
1.54% 1.54%
Expected volatility 99% to 197% 99% to 197%
Option life 10 years 10-15 years
Warrants
At the date of the reverse acquisition warrants over 388,148
shares existed at an exercise price of GBP1.50 per share. The
warrant is exercisable until 18 February 2016;
On 24 April 2014, warrants were granted over 1,095,000 shares at
an exercise price of GBP0.20 per share by way of an arrangement fee
for the convertible note holders agreeing to subscribe for
convertible loan notes. On the 28 April 2016, the Company received
notice from warrant holders to exercise warrants over 1,095,000
shares in the Company at an exercise price of GBP0.20 per share,
providing the Company with gross proceeds of GBP219,000.
On 16 June 2014, warrants were granted over 1,995,774 shares at
an exercise price of GBP0.32 per share by way of an arrangement fee
for the convertible note holders agreeing to subscribe for
convertible loan notes. The warrant is exercisable until 28 March
2017.
On 2nd March 2015, warrants were granted over 600,000 shares at
an exercise price of GBP0.50 per share in lieu of the issue of
options. The warrants are exercisable in 25% portions until 22
January 2016, 22 January 2017, 22 January 2018, and 22 January
2019.
On 20th April 2015, warrants were granted over 1,756,185 shares
at an exercise price of GBP2.50 per share by way of an arrangement
fee for the convertible note holders agreeing to subscribe for
convertible loan notes. The warrant is exercisable until 31
December 2020.
On 31st May 2015, warrants were granted over 292,500 shares at
an exercise price of GBP0.66 per share in lieu of fundraising fees.
The warrants are exercisable until 31 May 2022.
On 11th May 2015, warrants were granted over 55,000 shares at an
exercise price of GBP1.05 per share by way of an arrangement fee
for the convertible note holders agreeing to subscribe for
convertible loan notes. The warrant is exercisable until 31
December 2020.
On 16th December 2015, warrants were granted over 1,021,792
shares at an exercise price of GBP2.50 per share by way of an
arrangement fee for the convertible note holders agreeing to
subscribe for convertible loan notes. The warrant is exercisable
until 31 December 2020.
On 12th January 2016, warrants were granted over 189,176 shares
at an exercise price of GBP2.50 per share by way of an arrangement
fee for the convertible note holders agreeing to subscribe for
convertible loan notes. The warrant is exercisable until 31
December 2020.
On the 28th of June 2016, the Company received notice from
warrant holders to exercise warrants over 206,250 ordinary shares
at an exercise price of GBP0.32 per share, providing the Company
with gross proceeds of GBP66,000.
The Directors have estimated the fair value of the warrants in
services provided using an appropriate valuation model. The share
based payment charge for the six months to 30 June 2016 of GBP48k
(six months to June 2015: GBP205k twelve months to December 2015:
GBP102k) has been expensed in the statement of comprehensive
income.
8. Convertible loan notes
Planwise Convertible Loan Notes 2016
From the date of the reverse acquisition a convertible loan note
of GBP200,000 was in existence as detailed in the Admission
Document dated 31 March 2014. Proceeds of the subscriptions for the
notes are to be used exclusively to finance the Group's ongoing
working capital requirements. The terms of the loan note are that
the loan notes, plus accrued interest at a rate of 4 per cent above
Bank of England base rate per annum, will convert into ordinary
shares in the Company at a price of GBP0.10 per share at the
election of Planwise any time after the second anniversary of the
re-admission to AIM on 24 April 2014.
Accounting for the convertible debt instrument
The net proceeds received from the issue of the Planwise
Convertible Loan Note 2016 has been recorded as a debt liability in
the Statement of financial position and the accrued interest
charged to the Statement of comprehensive income and the debt
liability. The liability for the convertible debt instrument at 30
June 2016 is;
Planwise Convertible Loan Note 2016
GBP000
--------------------------------------
Convertible loan notes issued 200
Accrued interest 20
--------------------------------------
220
======================================
Investor Convertible Loan Notes: Tranche A
From the date of the reverse acquisition a Convertible Equity
Instrument of GBP730,000 was in existence as detailed in the
Admission Document dated 31 March 2014. Proceeds of the
subscriptions for the instruments are to be used to finance the
Group's on-going working capital requirements. The terms of the
equity instrument are that the instrument, plus accrued interest at
a rate of 6 per cent per annum, will convert into ordinary shares
in the Company at a price of GBP0.16 per share at the election of
the note holders any time after the date that is 180 days after the
readmission to AIM on 24 April 2014. There is no option to repay in
cash.
By way of an arrangement fee for the note holders agreeing to
subscribe GBP730,000 for the Investor Convertible Loan Notes:
Tranche A, the Company agreed to grant to the holders warrants to
subscribe for up to 1,095,000 Shares at an exercise price of
GBP0.20 per share. The fair value of these warrants is included in
the share based payment calculations for the period. These warrants
were exercised on the 28 April 2016.
Investor Convertible Loan Notes: Tranche B
On 16 June 2014 the Company entered into an agreement to issue
GBP1,451,472 of Convertible Equity Instruments. Proceeds of the
subscriptions for the instruments are to be used to finance the
Group's on-going working capital requirements. The terms of the
equity instrument are that the instrument, plus accrued interest at
a rate of 6 per cent per annum, will convert into ordinary shares
in the Company at a price of GBP0.24 per share at the election of
the note holders any time after 28 March 2015. There is no option
to repay in cash.
By way of an arrangement fee for the equity instrument holders
agreeing to subscribe GBP1,451,472 for the Investor Convertible
Loan Notes: Tranche B, the Company agreed to grant to the holders
warrants to subscribe for up to 1,995,774 Shares at an exercise
price of GBP0.32 per share. The fair value of these warrants is
included in the share based payment calculations for the period.
Some of these warrants holders exercised their warrants on 29 June
2016.
Investor Convertible Loan Notes: Tranche C
On 20 April 2015 the Company entered into an agreement to issue
GBP6,146,634 of Convertible Equity Instruments. Proceeds of the
subscriptions for the notes are to be used to finance the Group's
on-going working capital requirements. The terms of the equity
instrument are that the instrument, plus accrued interest at a rate
of 4 per cent per annum, will convert into ordinary shares in the
Company at a price of GBP0.70 per share at the election of the note
holders any time after 25 June 2016.
By way of an arrangement fee for the equity instrument holders
agreeing to subscribe GBP6,146,634 for the Investor Convertible
Loan Notes: Tranche C, the Company agreed to grant to the note
holders warrants to subscribe for up to 1,756,185 Shares at an
exercise price of GBP1.05 per share. The fair value of these
warrants is included in the share based payment calculations for
the period.
Investor Convertible Loan Notes: Tranche D
On 11 May 2015 the Company entered into an agreement to issue
GBP250,000 of Convertible Equity Instruments. Proceeds of the
subscriptions for the instruments are to be used to finance the
Group's on-going working capital requirements. The terms of the
equity instrument are that the instrument, plus accrued interest at
a rate of 4 per cent per annum, will convert into ordinary shares
in the Company at a price of GBP0.24 per share at the election of
the note holders any time after 28 March 2015.
By way of an arrangement fee for the equity instrument holders
agreeing to subscribe GBP250,000 for the Investor Convertible Loan
Notes: Tranche D, the Company agreed to grant to the holders
warrants to subscribe for up to 50,000 Shares at an exercise price
of GBP1.05 per share.
Investor Convertible Loan Notes: Tranche E
On 16 December 2015 the Company entered into an agreement to
issue GBP3,831,708 of Convertible Equity Instruments. Proceeds of
the subscriptions for the instruments are to be used to finance the
Group's on-going working capital requirements. The terms of the
equity instrument are that the instrument, plus accrued interest at
a rate of 6 per cent per annum, will convert into ordinary shares
in the Company at a price of GBP1.50 per share at the election of
the note holders any time after 31 December 2016.
By way of an arrangement fee for the equity instrument holders
agreeing to subscribe GBP3,831,708 for the Investor Convertible
Loan Notes: Tranche E, the Company agreed to grant to the holders
warrants to subscribe for up to 1,021,792 Shares at an exercise
price of GBP2.50 per share.
Investor Convertible Loan Notes: Tranche F
On 12 January 2016 the Company entered into an agreement to
issue GBP676,241 of Convertible Equity Instruments. Proceeds of the
subscriptions for the instruments are to be used to finance the
Group's on-going working capital requirements. The terms of the
equity instrument are that the instrument, plus accrued interest at
a rate of 6 per cent per annum, will convert into ordinary shares
in the Company at a price of GBP1.50 per share at the election of
the note holders any time after 31 December 2016.
By way of an arrangement fee for the equity instrument holders
agreeing to subscribe GBP676,241 for the Investor Convertible Loan
Notes: Tranche F, the Company agreed to grant to the holders
warrants to subscribe for up to 189,176 Shares at an exercise price
of GBP2.50 per share.
The principal amount of the Convertible Equity Instrument is
recorded as a shares to be issued reserve and the accrued interest
also charged to the same reserve.
A B C D E F Total
Balance as at
January 2016 859 1,531 5,800 256 3,841 - 12,287
Convertible equity
instruments issued - - - - - 676 676
Addition to Equity
(Interest) 22 25 123 5 114 19 308
Convertible equity
instruments exercised (150) (150)
881 1,406 5,923 261 3,955 695 13,121
==== ====== ====== ==== ====== ==== =======
9. Retained earnings
.
(unaudited) (unaudited)
6 months to 6 months to
30 June 30 June 31 Dec
2016 2015 2015
GBP'000 GBP'000 GBP'000
------------ ------------ ---------
Retained earnings brought forward (12,239) (3,405) (3,405)
Total comprehensive loss for the period (2,106) (4,111) (8,632)
Interest on convertible equity instruments (308) (112) (312)
Options cancelled in the year -- -- 110
------------ ------------ ---------
Retained earnings carried forward (14,653) (7,628) (12,239)
============ ============ =========
10. Trade and other payables
(unaudited) (unaudited) 12 months to
30 June 30 June 31 Dec
2016 2015 2015
GBP'000 GBP'000 GBP'000
------------ ------------ -------------
Convertible loan note liability 220 211 216
Trade and other payables 477 144 314
Accruals 212 152 216
Other creditors -- 250 --
909 757 746
Post balance sheet events
On the 30th of June 2016, the Company entered into an agreement
with its Legal Advisers, Cooleys LLP, to participate in a sale and
buy back of the Company's Deferred shares (108,121,391 of Deferred
shares of 4.9p each and 13,068,521 of Deferred shares of 9.99p
each). The Company subsequently applied to the Highcourt for
approval of a capital reduction which was granted on the 14th of
September 2016. The exercise was carried out to provide a more
accurate representation of the Company's balance sheet.
On 12 July 2016 the Company issued an amendment to Tranche F
Convertible Equity instruments. The original instrument had failed
to take into account 22,110 of the convertible loan notes which
were issued pursuant to the Original Instrument. This resulted in
an additional issue of GBP33,165 of Convertible Equity
Instruments.
On 18 July 2016 the Company purchased key assets from Shardna
SpA ("Shardna") a biobanking and genomics research company located
in Cagliari, Sardinia, for a total value of EUR258,000. The Company
also established an Italian subsidiary in Sardinia, LonGevia
Genomics Srl, specifically to develop these assets to identify
novel drug targets and diagnostic applications, through integration
with its global research network.
The Group is in the process of determining the fair values of
the acquired assets and a valuation is expected to be completed
before year end.
This information is provided by RNS
The company news service from the London Stock Exchange
END
IR BSGDCRUDBGLI
(END) Dow Jones Newswires
September 29, 2016 02:00 ET (06:00 GMT)
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