TIDMTILS
RNS Number : 0328O
Tiziana Life Sciences PLC
30 September 2019
Tiziana Life Sciences plc
("Tiziana" or "the Company")
Interim Results for the Six Months Ended 30 June 2019
Advancing pipeline of next generation therapeutics and
diagnostics for oncology and immune diseases of high unmet need
London, 30 September 2019 - Tiziana Life Sciences plc
("Tiziana", AIM: TILS, NASDAQ: TLSA), 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 2019.
Highlights during the period:
RESEARCH & DEVELOPMENT
CLINICAL PROGRAMMES
Foralumab
TZLS-401
Foralumab is a fully human engineered anti-CD3 monoclonal
antibody (mAB). It was in-licensed in December 2014 from Novimmune.
In January 2016, Tiziana outlined its clinical development plan for
Foralumab with initial plans to evaluate the drug in two clinical
indications: non-alcoholic steatohepatitis (NASH) and inflammatory
bowel disease (IBD).
As the only fully human engineered human anti-CD3 mAB in
clinical development, Foralumab has significant potential
advantages such as a shorter treatment duration and reduced
immunogenicity. With completion of the intravenous dosing for our
Phase 2a trial in Crohn's Disease, Foralumab's ability to modulate
T-cell response enables potential extension into a wide range of
other autoimmune and inflammatory diseases, such as GvHD,
ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D),
inflammatory bowel disease (IBD), psoriasis and rheumatoid
arthritis.
Foralumab is being developed as both an immunosuppressive and
immunomodulatory agent, with therapeutic benefits of rendering
T-cells unable to orchestrate an immune response and induction of
immune tolerance via maintenance of regulatory T-cells. There is
further potential for Foralumab to be combined with the Company's
TZLS-501, a fully human anti-IL-6R mAB in development to target
autoimmune and inflammatory diseases.
On 16 April, 2018, the Group entered into an exclusive license
agreement with The Brigham and Women's Hospital, Inc. relating to a
novel formulation of Foralumab dosed in a medical device for nasal
administration. An investigational new drug application (IND) for
the first-in-human evaluation of the nasal administration of
Foralumab in healthy volunteers was filed in the second quarter of
2018, and a Phase 1 trial to evaluate biomarkers of
immunomodulation of clinical responses was initiated in November
2018. The study was completed in September 2019 and Phase 1
clinical data demonstrated that nasally administered Foralumab, was
well-tolerated at all doses. Importantly, the treatment showed
significant positive effects on the biomarkers for activation of
mucosal immunity, which is capable of inducing site-targeted
immunomodulation to elicit anti-inflammatory effects.
Milciclib
TZLS-201
Milciclib, Tiziana's lead small molecule drug, was exclusively
licenced in January 2015 from Nerviano Medical Sciences. Milciclib
is an orally bioavailable, broad spectrum inhibitor of Cyclin
Dependent Kinases (CDKs): 1, 2, 4, 5 and 7 and Src family kinases.
Cyclin dependent kinases are a family of highly conserved enzymes
that are involved in regulating the cell cycle. Src family kinases
regulate cell growth and potential transformation of normal cells
to cancer cells. A unique feature of Milciclib is its ability to
reduce microRNAs, miR- 221 and miR-222, which silence gene
expression. miR-221 and miR-222 promote the formation of blood
vessels (angiogenesis) that are important for the spread of cancer
cells (metastasis). Levels of these microRNAs are consistently
increased in HCC patients and may contribute towards resistance to
treatment with Sorafenib. As a result, the Group are investigating
Milciclib both as a monotherapy and as a combination treatment with
Sorafenib.
To date, Milciclib has been studied in a total of eight
completed and ongoing Phase 1 and 2 clinical trials in 316
patients. In these trials, Milciclib was observed to be
well-tolerated and showed initial signals of anti-tumour action.
Prior to in-licensing, Milciclib was granted orphan designation by
the European Commission and by the U.S. Food and Drug
Administration ("FDA") for the treatment of malignant thymoma and
an aggressive form of thymic carcinoma in patients previously
treated with chemotherapy. In two Phase 2a trials, CDKO-125a-006
and CDKO125a-007, Milciclib showed signs of slowing disease
progression and acceptable safety.
The Group initiated a Phase 2a trial (CDKO-125a-010) of
Milciclib safety and tolerability as a single therapy in
Sorafenib-resistant patients with HCC in the first half of 2017. In
May 2018, the Independent Data Monitor committee (IDMC) completed
an interim analysis of tolerability data from the first eleven
treated patients and recommended expansion of the initial cohort to
an additional 20 patients to complete the trial enrolment, which
was completed in December 2018. Top-line data is expected in the
third quarter of 2019. This trial is conducted in
Sorafenib-resistant HCC patients. Typically, this population of
patients have an advanced form of the disease with poor prognosis
and an average overall survival expectancy of 3-5 months.
In March 2019, the IDMC reviewed safety data from patients as of
February 26, 2019 and concluded that the administration of
Milciclib to patients with advanced HCC was not associated with
unexpected signs or signals of toxicity. 28 out of 31 treated
patients were evaluable, 14 completed the 6-month duration study.
The most frequent adverse events such as diarrhea, ascites, nausea,
fatigue, asthenia, fever, ataxia, headache, and rash were
manageable. No drug-related deaths were recorded.
As per the study protocol, data collection was limited to
6-months. Thus, clinical data were not collected from patients
under compassionate use treatment. The clinical activity assessment
in evaluable patients was based on the investigators' review using
the modified Response Evaluation Criteria in Solid Tumors
(mRECIST).
-- 9 out of 14 patients (64.2%) were approved by their
respective ethical committees to continue the treatment.
-- 5 of the 9 patients on compassionate use had received
Milciclib for a total of 9, 9, 11, 13 and 16 months.
-- As of 1 September 2019, the remaining 4 patients continuing
the treatment are in their 10th, 11th, 11th and 12th months.
-- Both median TTP and PFS were 5.9 months (95% Confidence
Interval ("CI") 1.5-6.7 months) out of the 6-months duration of the
trial.
-- 17 of 28 (60.7%) evaluable patients showed 'Stable Disease'
(SD; met at least once in an 8-week interval).
-- One patient (3.6%) showed 'Partial Response' (PR, unconfirmed).
-- 18 of 28 (64.3%) evaluable patients showed 'Clinical Benefit
Rate' defined as CBR=CR+PR+SD (with CR representing Complete
Remission).
Preclinical data presented at the AASLD meeting in November
2018, demonstrated significant tumour reduction in an orthotopic
mouse model of HCC following five weeks of treatment with Milciclib
(-20% reduction, 30mg/kg/day)), Sorafenib (-20% reduction, 20
mg/kg/day) and the combination of Milciclib and Sorafenib (-38%
reduction) relative to vehicle control.
PRE-CLINICAL PROGRAMMES
Anti IL-6R mAb
TZLS-501, formerly NI-1201
TZLS-501 is a fully human engineered mAb targeting the
interleukin-6 receptor (IL-6R). Tiziana Life Sciences licensed the
intellectual property from Novimmune in January 2017. This fully
human mAb has a unique mechanism of action that binds to both the
membrane-bound and soluble forms of the IL-6R resulting in lowering
of circulating levels of IL-6 in the blood. Excessive production of
IL-6 is regarded as a key driver of chronic inflammation,
associated with autoimmune diseases such as multiple myeloma,
oncology indications and rheumatoid arthritis, and the Group
believes that TZLS-501 may have potential therapeutic value for
these indications.
In preclinical studies, TZLS-501 demonstrated the potential to
overcome limitations of other IL-6 blocking pathway drugs. Compared
to tocilizumab and sarilumab, while binding to the membrane-bound
IL-6R complex TZLS-501 has shown a higher affinity for the soluble
IL-6 receptor as seen from the antibody binding studies conducted
in cell culture. TZLS-501 also demonstrated the potential to block
or reduce IL-6 signalling in mouse models of inflammation. The
soluble form of IL-6 has been implicated to have a larger role in
disease progression compared to the membrane-bound form. (Kallen,
K.J. (2002). "The role of transsignalling via the agonistic soluble
IL-6 receptor in human diseases". Biochimica et Biophysica Acta.
1592 (3): 323-343.).
StemPrintER(TM)
StemPrintER is a multi-gene signature assay intended for use in
patients diagnosed with estrogen-receptor positive ER+/HER2
negative breast cancers. The Group believes this in-vitro
prognostic test will be used in conjunction with clinical
evaluation to identify those patients at increased risk for early
and/or late metastasis.
FINANCIAL
-- For the six months to 30 June 2019 the consolidated Group
made a loss of GBP3.63m (six months to 30 June 2018: GBP3.94m).
-- The Group ended the period with GBP0.4m cash as at 30 June
2019 (31 December 2018: GBP4.1m).
The Company continues to carefully manage its working capital
position and continues the process, as referred to below, to seek
to raise further funds through the issue of ADSs through a United
States Offering as well as through private placements.
Highlights post period:
-- On 22 July, 2019, the Group announced the preliminary topline
clinical data from a Phase 2a trial of Milciclib as a monotherapy
in patients with advanced hepatocellular carcinoma (HCC), the most
common form of liver cancer. The primary endpoint of the study was
overall safety. Under compassionate use, a few patients continued
with total treatment for up to 16 months. Overall, treatment with
Milciclib was well-tolerated and no drug-related deaths were
recorded. Secondary endpoints of efficacy including
progression-free survival (PFS) and time to progression (TTP) are
currently being evaluated and will subsequently be reported.
-- On 6 August 2019, the Company announced the commencement of
an underwritten public offering in the United States of American
Depositary Shares ("ADSs"), representing ordinary shares of nominal
value GBP0.03 each in the capital of the Company ("Ordinary
Shares") on the NASDAQ Global Market (the "Offering"). There can be
no assurance as to whether or when the Offering may be completed,
or as to the actual size or terms of the Offering. The price for
the Offering has not yet been determined.
-- On 4 September 2019 the Group announced additional positive
Phase 2a clinical data exhibiting impressive clinical activity of
Milciclib monotherapy in patients with advanced Sorafenib-resistant
or -intolerant patients with unresectable or metastatic
hepatocellular carcinoma (HCC).
-- On 16 September 2019 the Group announced that the U.S. Food
and Drug Administration (FDA) has allowed the initiation of a Phase
I clinical trial in healthy volunteers using a novel oral
enteric-coated capsule formulation of Foralumab, a fully human
monoclonal antibody (mAb), in collaboration with the Brigham and
Women's Hospital (BWH), Harvard Medical School, Boston, MA. This is
the first clinical trial in which Foralumab will be administered
orally to healthy subjects. The objective is to develop orally
administered Foralumab for treatment of autoimmune and inflammatory
diseases.
Contacts:
Tiziana Life Sciences plc
Gabriele Cerrone, Chairman and founder +44 (0)20 7495 2379
Cairn Financial Advisers LLP (Nominated
adviser)
Liam Murray / Jo Turner +44 (0)20 7213 0880
Shore Capital (Broker)
Antonio Bossi / Fiona Conroy +44 (0)20 7408 4050
About Tiziana Life Sciences
Tiziana Life Sciences plc is a UK biotechnology company that
focuses on the discovery and development of novel molecules that
treat human disease in oncology and immunology.
The Company is focused on its lead compound, milciclib, a
molecule 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
completing phase II clinical trials for epithelial thymic carcinoma
and/or thymoma in patients previously treated with chemotherapy and
has filed an IND to enroll patients in an exploratory trial in
Hepatocellular Carcinoma (HCC) in EU.
The Company is also in clinical development of foralumab. We
believe foralumab is the only fully human anti-human CD3 antibody
in clinical development in the world. This compound has potential
application in a wide range of autoimmune and inflammatory
diseases, such as NASH, primary biliary cholangitis (PBS),
ulcerative colitis, MS, type-1 diabetes (T1D), inflammatory bowel
disease (IBD), psoriasis and rheumatoid arthritis, where modulation
of a T-cell response is desirable 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 2019.
Background
Tiziana Life Sciences plc is a publicly-listed (NASDAQ: TLSA;
AIM: TILS) biotechnology company focused on the discovery and
clinical development of innovative therapeutics for cancers,
autoimmune and inflammatory diseases. The Group combines
field-leading medical scientists, providing deep knowledge and
novel insights into disease mechanisms, together with a highly
experienced clinical development team. Since its foundation in
2013, Tiziana Life Sciences has expanded its pipeline of assets to
include clinical stage development therapeutic candidates in both
oncology and immunology, as well as a pre-clinical drug discovery
pipeline of small molecule New Chemical Entities.
The business employs a lean and virtual business model using
highly experienced teams of experts for each business function to
maximize value accretion and focus capital on the drug development
and discovery processes.
In January 2017 the Company established its own R&D
facilities at Doylestown Pennsylvania, employing resources with
long standing and high qualified experience in the industry.
Financial summary
The Group has made a loss for the six months to 30 June 2019 of
GBP3.63m (six months to 30 June 2018: GBP3.94m). The loss is
detailed in the consolidated statement of comprehensive income.
The Group ended the period with GBP0.4m cash as at 30 June 2019
(31 Dec 2018: GBP4.1m).
Fund raising
During the six months to 30 June 2019, Tiziana has not engaged
in any fundraising, but it signed an agreement with an underwriter
on 25 June 2019 with a view to raise funds in the near future.
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
On 4 September 2019, Tiziana Life Sciences announced additional
positive Phase 2a clinical data exhibiting impressive clinical
activity of Milciclib monotherapy in patients with advanced
Sorafenib-resistant or intolerant patients with unresectable or
metastatic hepatocellular carcinoma (HCC). This Phase 2a
multi-center, single-arm, repeated-dose (100 mg once daily; 4 days
on/3 days off for 4 weeks; defining each cycle) and 6-month
duration study was conducted to evaluate the safety, tolerability
and anti-tumor activity of Milciclib in Sorafenib-resistant
patients with unresectable or metastatic advanced HCC. The trial
enrolled 31 patients in Italy, Greece and Israel, of which 28
patients were evaluable. While the primary endpoint of this study
was overall safety, secondary endpoints were also evaluated. As
previously announced on 22 July 2019, the clinical data from the
Phase 2a trial indicated that Milciclib was well tolerated with
manageable toxicities and no recorded drug related deaths, thereby
meeting the trial's primary endpoint. The Group expects to initiate
a Phase 2b trial dosing Milciclib in combination with Sorafenib
(the standard of care) in patients with HCC in the second half of
2019.
On 16 April 2018, the Group entered into an exclusive license
agreement with The Brigham and Women's Hospital, Inc. relating to a
novel formulation of Foralumab dosed in a medical device for nasal
administration. An investigational new drug application (IND) for
the first-in-human evaluation of the nasal administration of
Foralumab in healthy volunteers was filed in the second quarter of
2018, and a Phase 1 trial to evaluate biomarkers of
immunomodulation of clinical responses was initiated in November
2018. The study was completed in September 2019 and Phase 1
clinical data demonstrated that nasally administered Foralumab, was
well-tolerated at all doses. Importantly, the treatment showed
significant positive effects on the biomarkers for activation of
mucosal immunity, which is capable of inducing site-targeted
immunomodulation to elicit anti-inflammatory effects.
Outlook
It has been a busy six months for the Company as we continue to
progress our pipeline of drugs to treat rare cancers and difficult
to treat autoimmune inflammatory diseases.
Milciclib met the primary endpoint and secondary endpoints in
two phase IIa multi-centered single arm, repeated dose clinical
trials in thymic carcinoma (TC) and Thymoma (B3T) patients Based on
satisfying results from the completion of a 6 month trial with 14
sorafenib-resistant HCC patients, which demonstrated that
toxicities of the miclicib treatment is manageable, the Group
expects to initiate a Phase 2b trial (TZLS (201)-125a-011) dosing
Milciclib in combination with Sorafenib (the standard of care) in
patients with HCC. This is due to commence in the second half of
2019.
Following the approval of our Investigational New Drug ("IND")
application to the U.S. Food and Drug Administration, phase 1
Clinical Trials with nasally administered Foralumab in healthy
volunteers were successfully completed. The trials showed a
positive trend in biomarkers of immunmodulation and anti
inflammation. We expect to commence a phase 2 study in the
forthcoming months.
The U.S. Food and Drug Administration (FDA) has allowed the
initiation of a Phase I clinical trial in healthy volunteers using
a novel oral enteric-coated capsule formulation of Foralumab, a
fully human monoclonal antibody (mAb), in collaboration with the
Brigham and Women's Hospital (BWH), Harvard Medical School, Boston,
MA. This is the first clinical trial in which Foralumab will be
administered orally to healthy subjects. Our objective is to
develop orally administered Foralumab for treatment of autoimmune
and inflammatory diseases.
Looking ahead, Tiziana is confident that it is well positioned
to advance these programs to their next respective value inflection
points.
Gabriele Cerrone
Executive Chairman
Consolidated Statement of Comprehensive
Income
for the six months ended 30 June 2019
6 months 6 months 12 months
to 30 June to 30 June to 31 Dec
2019 2018 2018
GBP'000 GBP'000 GBP'000
Notes (unaudited) (unaudited)
------------ ------------ -----------
Research and development (1,507) (2,281) (4,132)
Operating expenses (2,202) (1,575) (3,313)
Operating loss (3,709) (3,856) (7,445)
Financial income -- -- --
Financial expense (5) (4) (9)
Operating loss before taxation 5 (3,714) (3,860) (7,454)
Taxation 27 -- 1,459
Operating loss after taxation (3,687) (3,860) (5,995)
Net loss for the period attributable
to equity owners (3,687) (3,860) (5,995)
Other comprehensive income
for the period 52 (77) (113)
Total comprehensive loss
attributable to equity owners (3,635) (3,937) (6,108)
============ ============ ===========
Basic and diluted loss per
share (pence)
Basic and diluted loss per
share on continuing operations 6 (2.9p) (3.1p) (4.7p)
============ ============ ===========
Total basic and diluted loss
per share (2.9p) (3.1p) (4.7p)
============ ============ ===========
Consolidated Statement of Financial
Position
as at 30 June 2019
30 June 30 June 31 Dec
2019 2018 2018
GBP'000 GBP'000 GBP'000
Notes (unaudited) (unaudited)
------------ ------------ -----------
Assets
Non-Current assets:
Property, plant and equipment 7 5 12 6
Right-of-use assets 4 358 -- --
Other non-current assets 217 217 217
Total Non-current assets 580 229 223
Current assets:
Trade and other receivables 8 245 53 248
Taxation receivable 827 965 800
Cash and cash equivalents 445 66 4,165
------------ ------------ -----------
Total current assets 1,517 1,084 5,213
Total assets 2,097 1,313 5,436
============ ============ ===========
Equity and liabilities
Shareholders' equity
Called up share capital 4,094 3,806 4,094
Share premium 25,896 20,271 25,894
Share based payment reserve 3,021 3,017 2,857
Shares to be issued reserve 612 485 548
Convertible loan note reserve -- -- --
Merger relief reserve -- -- --
Capital reduction reserve 31,183 31,183 31,183
Other reserve (28,286) (28,286) (28,286)
Translation reserve (61) - (113)
Retained earnings 9 (39,453) (33,692) (35,766)
------------ ------------ -----------
Equity attributed to the
owners of the Company (2,994) (3,216) 411
Current liabilities:
Trade and other payables 11 4,727 4,131 5,025
------------ ------------ -----------
Lease Liabilities - current 87
------------ ------------ -----------
4,814 4,131 5,025
Long term liabilities:
Fixed term loans -- 398 --
Lease Liabilities - non-current 4 277
Total Liabilities 5,091 4,529 5,025
Total Equity and Liabilities 2,097 1,313 5,436
============ ============ ===========
Consolidated Statement of Cash Flows
for the 6 months ended 30 June 2019
6 months 6 months 12 months
to to to 31 Dec
30 June 30 June
2019 2018 2018
GBP'000 GBP'000 GBP'000
(unaudited) (unaudited)
------------ ------------ -----------
Cash flows from operating activities
Total comprehensive loss for the
period before tax (3,714) (3,860) (7,454)
Convertible loan interest accrued -- -- 9
Convertible loan interest paid as
equity 5 4 16
Shares issued in lieu of fees - - 41
Share based payment - options 164 663 504
Cancellation of options -- -- -
Share based payment - warrants 64 66 128
Net (increase) / decrease in operating
assets
-Trade / other receivables 3 590 (135)
Net increase / (decrease) in operating
liabilities
-Trade / other liabilities (307) 617 1,592
Depreciation 1 6 12
Loss on foreign exchange 56 (144) (222)
Lease adjustment 6 3 3
------------ ------------ -----------
Net cash used in operating activities
Cash inflow from taxation
(3,722) (2,055) (5,506)
Net cash used in operating activities
-- -- 2,093
Cash flow from financing activities
Proceeds from issuance of ordinary -- -- (3,413)
shares
Proceeds from issuance of convertible
loan notes
Proceeds from issuance of loans 2 1,675 7,437
Fundraising costs -- -- --
Net cash generated from financing -- 398 1,132
activities -- -- (1,039)
Cash flows from investing activites 2 2,073 7,530
Acquisition of property, plant and
equipment
Acquisitionof other investments -- -- -
Net cash generated from investing -- -- -
activities
-- -- -
Net increase / (decrease) in cash
and cash equivalents (3,720) 18 4,117
Cash and cash equivalents at beginning
of period 4,165 48 48
Cash and cash equivalents at end
of period 445 66 4,165
------------ ------------ -----------
Consolidated Statement of Changes in Equity
for the six months ending 30 June 2019 and 30 June 2018
Share Shares
Based to Be Capital Translation
Share Share Payment Issued Reduction Reserve Other Retained Total
(Unaudited) Capital Premium Reserve Reserve Reserve Reserve Earnings Equity
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
Balance at 1
January 2019 4,094 25,894 2,857 548 31,183 (113) (28,286) (35,766) 411
Transactions
with owners
Issue of share
capital - 2 - - - - - - 2
Share based
payments
(options) - - 662 - - - - - 662
Forfeiture of
options (498) (498)
Share based
payments
(warrants) - - - 64 - - - - 64
Total
transactions
with owners - 2 164 64 - - - - 641
Comprehensive
income
Loss for the
period - - - - - - - (3,687) (3,687)
Foreign
currency
translation - - - - - 52 - - 52
Total
comprehensive
income - - - - - 52 - (3,687) (3,635)
Balance at 30
June 2019 4,094 25,896 3,021 612 31,183 (61) (28,286) (39,453) (2,994)
--------- --------- -------- -------- ----------- ------------- --------- ---------- --------
Balance at 1
January 2018 3,752 18,650 2,354 419 31,183 - (28,286) (29,755) (1,683)
Transactions
with owners
Issue of share
capital 54 1,621 - - - - - - 1,675
Share based
payments
(options) - - 663 - - - - - 663
Share based
payments
(warrants) - - - 66 - - - - 66
-
--------- --------- -------- -------- ----------- ------------- --------- ---------- --------
Total
transactions
with owners 54 1,621 663 66 - - - - 2,404
Comprehensive
income
Loss for the
period - - - - - - - (3,860) (3,860)
--------- --------- -------- -------- ----------- ------------- --------- ---------- --------
Foreign
currency
translation - - - - - - - (77) (77)
Total
comprehensive
income - - - - - - - (3,937) (3,937)
Balance at 30
June 2018 3,806 20,271 3,017 485 31,183 - (28,286) (33,692) (3,216)
--------- --------- -------- -------- ----------- ------------- --------- ---------- --------
Share Share Capital Share Shares Convertible Other Translation Retained Total
Capital Premium Reduction Based to Be Loan Note reserve reserve Earnings Equity
Reserve Payment Issued Reserve
Reserve Reserve
(warrants)
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
Balance as at 1
January 2018 3,752 18,650 31,183 2,354 419 - (28,286) - (29,755) (1,683)
Transactions with
owners
Issue of share
capital
(private placement
and IPO) 232 4,864 - - - - - - - 5,096
Issue of share
capital
(warrants) 44 1,085 - - - - 1,129
Issue of share
capital
(loan conversion) 64 1,240 - - - - - - - 1,304
Share based payment
(options) - - - 503 - - - - - 503
Issue of share
capital
in lieu of fees 1 40 - - - - - - - 41
Convertible loan
note interest 1 15 - - - - - - (16) -
Share based payment
(warrants) - - - - 129 - - - - 129
-------- --------- ---------- -------- ----------- ------------ ----------- ------------ ----------- --------
Total transactions
with owners 342 7,244 - 503 129 - - - (16) 8,202
Comprehensive
income
Exchange
differences
on translating
foreign
operations - - - - - - - (113) - (113)
Loss for the year - - - - - - - (5,995) (5,995)
---------- -------- -----------
Total comprehensive
income - - - - - - - (113) (5,995) (6,108)
-
-------- --------- ---------- -------- ----------- ------------ ----------- ------------ ----------- --------
Balance as at 31
December 2018 4,094 25,894 31,183 2,857 548 - (28,286) (113) (35,766) 411
======== ========= ========== ======== =========== ============ =========== ============ =========== ========
Notes to the Interim Financial Statements
for the six month period to 30 June 2019
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)
and on the NASDAQ Capital Market (NDAQ: TLSA). 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 financial statements are presented in thousands of pounds
sterling (GBP'000) which is the functional currency of the primary
economic environment in which the Company 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 principal accounting policies applied in the preparation of
these consolidated financial statements are set out below. These
policies have been applied consistently to all the years presented
unless otherwise stated.
Basis of preparation
These interim consolidated financial statements have been
prepared using accounting policies based on International Financial
Reporting Standards (IFRS and IFRIC Interpretations) issued by the
International Accounting Standards Board ("IASB") as adopted for
use in the EU. They do not include all disclosures that would
otherwise be required in a complete set of financial statements and
should be read in conjunction with the 31 December 2018 Annual
Report and Financial Statements. The financial information has not
been prepared (and is not required to be prepared) in accordance
with IAS 34 Interim Financial Reporting. The annual consolidated
financial statements of the group are prepared in accordance with
IFRS as adopted by the European Union. The comparative financial
information for the year ended 31 December 2018 included within
this report does not constitute the full statutory Annual Report
for that period.
The Group has applied the same accounting policies and methods
of computation in its interim consolidated financial statements as
in its 2018 annual financial statements, as set out in Note 2 of
that document, except for the adoption of IFRS 16.
Going Concern
The Group incurred losses during the year and has net
liabilities at the year end.
The Group is in the early stages of developing its business
focusing on the discovery and development of novel molecules that
treat human disease in oncology and immunology. The Directors
expect the company to incur further losses and to require
significant capital expenditure in continuing to develop clinical
stage development therapeutic candidates in both oncology and
immunology. The company has successfully funded clinical trials to
date and is in the process of securing additional investment for
purposes of continuing to fund their clinical trials moving
forward.
The Directors have prepared cash flow projections that include
the costs associated with the continued clinical trials and
additional investment to fund that operation. On the basis of those
projections, the Directors conclude that the company will be able
to meet its liabilities as they fall due for the foreseeable
future, and therefore that it is appropriate to prepare the
financial statements under the going concern basis of
preparation.
However, until and unless the Group secures sufficient
investment to fund their clinical trials, there is a material
uncertainty about the Group's ability to continue as a going
concern, and therefore about the applicability of the going concern
basis of preparation. The financial statements do not include the
adjustments that would be required if the going concern basis of
preparation was considered inappropriate.
New and Revised Standards
Standards in effect in 2019
IFRS 16 'Leases' has come into effect from 1 January 2019 and
has been adopted by the Group. The impact of the adoption of the
leasing standard is disclosed in Note 4 below.
IFRS in issue but not applied in the current financial
statements
The Directors do not expect that the adoption of new IFRS
Standards, Interpretations and Amendments that have been issued but
are not yet effective will have a material impact on the financial
statements of the Group in future periods.
Beyond the information above, it is not practicable to provide a
reasonable estimate of the effect of these standards until a
detailed review has been completed.
A number of IFRS and IFRIC interpretations are also currently in
issue which are not relevant for the Group's activities and which
have not therefore been adopted in preparing these financial
statements.
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 control
and are de-consolidated from the date at which control ceases.
Business combination
The consolidated position of the Group is as a result of the
reverse acquisition of Alexander David Investments plc by Tiziana
Pharma Ltd and the subsequent listing of the Company as Tiziana
Life Sciences plc on 24 April 2014. Reverse acquisition for the
business combination in the year as detailed below:
On 24 April 2014, the Company (Alexander David Investments plc,
(ADI)) acquired via a share for share exchange the entire issued
share capital of Tiziana Pharma Limited, whose principal activity
is that of a clinical stage biotechnology company focussed on
targeted drugs to treat diseases in oncology and immunology.
Due to the relative values of the companies, the former Tiziana
Pharma Limited shareholders became majority shareholders with 96.1%
of the enlarged share capital in ADI which was renamed Tiziana Life
Sciences plc, and hence hold the majority of the voting rights.
Furthermore, the executive management of Tiziana Pharma Limited
became the executive management of Tiziana Life Sciences plc. A
qualitative and quantitative analysis of these factors led the
Directors to conclude that in this transaction Tiziana Pharma
Limited has the controlling interest and should be treated as the
accounting acquirer.
In determining the appropriate accounting treatment for the
reverse acquisition, the Directors considered the Application
Supplement to IFRS 3, Business combinations. However, they
concluded that this transaction fell outside the scope of IFRS 3
since Tiziana Life Sciences plc, whose activity prior to the
acquisition was purely the maintenance of the AIM listing, did not
constitute a business. It was therefore determined that the
transaction should be accounted for in a manner that was similar to
the reverse acquisition accounting as described in IFRS 3, but
without recognising goodwill.
The following accounting treatment has been applied in respect
of the reverse acquisition;
-- The assets and liabilities of the legal subsidiary, Tiziana
Pharma Limited are recognised and measured in the consolidated
financial statements at their pre-combination carrying amounts,
without restatement to their fair value.
-- The retained reserves recognised in the consolidated
financial statements reflect the retained reserves of Tiziana
Pharma Limited to the date of acquisition.
-- In applying IFRS 3 by analogy, the equity structure appearing
in the consolidated financial statements reflects the equity
structure of the legal parent Tiziana Life Sciences plc, including
the equity instruments issued under the share exchange to effect
the business combination.
-- A reverse acquisition reserve has been created to enable the
presentation of a consolidated balance sheet which combines the
equity structure of the legal parent with the non-statutory
reserves of the legal subsidiary.
-- Comparative numbers are based upon the consolidated financial
statements of the legal subsidiary, Tiziana Pharma Limited for the
year ended 31 December 2013 apart from the equity structure which
reflects that of the parent.
Tiziana Pharma Limited was incorporated on 4 November 2013 and
prepared its first set of financial statements to 31 December 2014.
Therefore, the parent and subsidiary had the same reporting date
but Tiziana Pharma Limited had a long period of account. No
adjustment was made in the consolidated financial statements for
the difference in length of reporting period because the only
transaction in Tiziana Pharma Limited at 31 December 2013 was the
issue of ordinary share capital of GBP1.
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.
Segment reporting
Operating segments are reported in a manner consistent with the
internal reporting provided to the Board. The Board allocates
resources to and assess the performance of the segments. The Board
considers there to be only one operating segment being the research
and development of biotechnological and pharmaceutical
products.
Taxation
The tax expense for the year represents the total of current
taxation and deferred taxation. The charge in respect of current
taxation is based on the estimated taxable profit for the year.
Taxable profit for the year is based on the profit as shown in the
income statement, as adjusted for items of income or expenditure
which are not deductible or chargeable for tax purposes. The
current tax liability for the year is calculated using tax rates
which have either been enacted or substantively enacted at the
balance sheet date.
Deferred tax is provided in full, using the liability method on
temporary differences arising between the tax base of assets and
liabilities and their carrying values in the financial statements.
The deferred tax is not accounted for if it arises from initial
recognition of an asset or liability in a transaction other than a
business combination that at the time of the transaction affects
neither accounting nor taxable profit or loss. Deferred tax is
determined using tax rates which have been enacted or substantively
enacted at the balance sheet date and are expected to apply when
the related deferred tax asset is realised or the deferred income
tax liability is settled.
Deferred tax assets are recognised to the extent that it is
probable that future taxable profits will be available against
which the temporary differences can be utilised.
Deferred tax is provided on temporary differences arising on
investments in subsidiaries and associates, except where the timing
of the reversal of the temporary difference is controlled by the
group and it is probable that the temporary difference will not
reverse in the foreseeable future.
Foreign currency translation
Foreign currency transactions are translated using the rate of
exchange applicable at the date of the transaction. Foreign
exchange gains and losses resulting from the settlement of such
transactions and from the re-translation at the year end of
monetary assets and liabilities denominated in foreign currencies
are recognised in the income statement.
On consolidation, the assets and liabilities of foreign
subsidiaries are translated into Pound Sterling at the rate of
exchange prevailing at the reporting date and their statements of
comprehensive income are translated at exchange rates prevailing at
the dates of the transactions. The exchange differences arising on
translation for consolidation are recognised in other comprehensive
income. On disposal of a foreign subsidiary, the component of other
comprehensive income relating to that particular foreign subsidiary
is recognised in profit or loss.
Research and development
All on-going research and development expenditure is currently
expensed in the period in which it is incurred. Due to the
regulatory environment inherent in the development of the Group's
products, the criteria for development costs to be recognised as an
asset, as set out in IAS 38 'Intangible Assets', are not met until
a product has been granted regulatory approval and it is probable
that future economic benefit will flow to the Group. The Group
currently has no qualifying expenditure.
Financial instruments
The Group classifies a financial instrument, or its component
parts, as a financial liability, a financial asset or an equity
instrument in accordance with the substance of the contractual
arrangement and the definitions of a financial liability, a
financial asset and an equity instrument.
The Group evaluates the terms of the financial instrument to
determine whether it contains an asset, a liability or an equity
component. Such components shall be classified separately as
financial assets, financial liabilities or equity instruments.
A financial instrument is any contract that gives rise to a
financial asset of one entity and a financial liability or
equity instrument of another entity.
(a) Financial assets, initial recognition and measurement and
subsequent measurement
All financial assets not recorded at fair value through profit
or loss, such as receivables and deposits, are
recognized initially at fair value plus transaction costs.
Financial assets carried at fair value through profit or loss are
initially recognized at fair value, and transaction costs are
expensed in the income statement.
The measurement of financial assets depends on their
classification. Financial assets such as receivables and deposits
are subsequently measured at amortized cost using the effective
interest method, less loss allowance. The Group does not hold any
financial assets at fair value through profit or loss or fair value
through other comprehensive income.
(b) Financial liabilities, initial recognition and measurement
and subsequent measurement
Financial liabilities are classified as measured at amortized
cost or FVTPL.
A financial liability is classified as at FVTPL if it is a
derivative. Financial liabilities at FVTPL are measured at fair
value and net gains and losses, including any interest expense, are
recognized in profit or loss.
Other financial liabilities are subsequently measured at
amortized cost using the effective interest method.
Interest expense and foreign exchange gains and losses are
recognized in profit or loss. Any gain or loss on
derecognition is also recognized in profit or loss.
The Group's financial liabilities include trade and other
payables.
Share capital
Ordinary shares of the company are classified as equity.
Property, plant and equipment
(i) Recognition and measurement
Items of property, plant and equipment are measured at cost less
accumulated depreciation and accumulated impairment losses. Costs
include expenditures that are directly attributable to the
acquisition of the asset. Purchased software that is integral to
the functionality of the related equipment is capitalised as part
of that equipment.
When parts of an item of property, plant and equipment have
different useful lives, they are accounted for as separate items
(major components) of property, plant and equipment.
Gains and losses on disposal of an item of property, plant and
equipment are determined by comparing the proceeds from disposal
with the carrying amount of property, plant and equipment, and are
recognised in profit or loss. When revalued assets are sold, the
amounts included in the revaluation reserve are transferred to
retained earnings.
(ii) Depreciation
Depreciation is calculated on the depreciable amount, which is
the cost of an asset, or other amount substituted for cost, less
its residual value.
Depreciation is recognised in profit or loss on a straight-line
basis over the estimated useful life of each part of an item of
property, plant and equipment. Leased assets are depreciated over
the shorter of the lease term and their useful lives unless it is
reasonably certain that the Company will obtain ownership by the
end of the lease term.
The estimated useful lives for the current period and the
comparative period are as follows.
IT and equipment 3 years
Fixtures and fittings 5 years
Depreciation methods, useful lives and residual values are
reviewed at each reporting date. Depreciation is allocated to the
operating expenses line of the income statement.
Impairment
Impairment of financial assets measured at amortised cost
At each reporting date the Group recognises a loss allowance for
expected credit losses on financial assets measured at amortised
cost.
In establishing the appropriate amount of loss allowance to be
recognised, the Group applies either the general approach or the
simplified approach, depending on the nature of the underlying
group of financial assets.
General approach
The general approach is applied to the impairment assessment of
refundable lease deposits and other refundable lease contributions,
restricted cash and cash and cash equivalents.
Under the general approach the Group recognises a loss allowance
for a financial asset at an amount equal to the 12-month expected
credit losses, unless the credit risk on the financial asset has
increased significantly since initial recognition, in which case a
loss allowance is recognised at an amount equal to the lifetime
expected credit losses.
Simplified approach
The simplified approach is applied to the impairment assessment
of trade receivables.
Under the simplified approach the Group always recognises a loss
allowance for a financial asset at an amount equal to the lifetime
expected credit losses.
Non-financial assets are tested for impairment whenever events
or changes in circumstances indicate that the carrying amount may
not be recoverable.
Non-financial assets are impaired when its carrying amount
exceed its recoverable amount. The recoverable amount is measured
as the higher of fair value less cost of disposal and value in use.
The value in use is calculated as being net projected cash flows
based on financial forecasts discounted back to present value.
Leases
IFRS 16 Leases was issued in January 2016 and was implemented by
the Group from 1 January 2019. The Standard replaces IAS 17 and
requires lease liabilities and 'right of use' assets to be
recognised on the balance sheet for almost all leases. The adoption
methodology of IFRS 16 is the cumulative catch-up method, and the
impact of adoption was to recognise a right of use asset of GBP435k
and a lease liability of GBP435k on 1 January, 2019.
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.
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. Non market 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.
Other non-current assets
Other current assets are currently measured at cost less
accumulated impairment. The asset is not yet being amortised since
it is not yet in the condition necessary for it to be capable of
operating in the manner intended by management.
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 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 in a
Convertible loan note reserve. The accrued interest on the
principal amount is also recorded in the Convertible loan note
reserve. Upon redemption of the instrument and the issue of share
capital, the amount is reclassified from the convertible loan note
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 balance sheet. The accrued interest on
the principal amount is recorded in the income statement 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.
3. CRITICAL ACCOUNTING ESTIMATES AND JUDGEMENTS
The preparation of financial information in accordance with
generally accepted accounting practice, in the case of the Group
being International Financial Reporting Standards ('IFRS') as
adopted by the European Union, requires the Directors to make
estimates and judgements that affect the reported amount of assets,
liabilities, income and expenditure and the disclosures made in the
financial statements. Such estimates and judgements must be
continually evaluated based on historical experience and other
factors, including expectations of future events.
When entering into agreements with third parties which provide
the rights to conduct research into specific biological processes
the group account for these agreements as an expense if the
agreements are 'milestone' in nature and relate to the Group's own
research and development costs. Such agreements involve periodic
payments and are evaluated as representing payments made to fund
research.
The only other critical accounting estimates and judgements in
the preparation of the financial statements were fair value
estimates used in the calculation of share based payments and
warrants which have been detailed above in note 2, accounting
policies, and note 8, share based payments, to the accounts.
4. CHANGES IN ACCOUTING POLICIES
The group has adopted IFRS 16 retrospectively from 1 January
2019, but has not restated comparatives for the 2018 reporting
period, as permitted under the specific transitional provisions in
the standard. The reclassifications and the adjustments arising
from the new leasing rules are therefore recognised in the opening
balance sheet on 1 January 2019.
On adoption of IFRS 16, the group recognised lease liabilities
in relation to leases which had previously been classified as
'operating leases' under the principles of IAS 17 Leases. These
liabilities were measured at the present value of the remaining
lease payments, discounted using the lessee's incremental borrowing
rate as of 1 January 2019. The weighted average lessee's
incremental borrowing rate applied to the lease liabilities on 1
January 2019 was 3.35%.
The Group assesses whether a contract is or contains a lease at
inception of the contract. The Group recognises a right-of-use
assets and corresponding lease liabilities at the lease
commencement date, except for short term leases and leases of low
value. For these leases, the lease payments are recognised as an
operating expense on a straight-line basis over the term of term of
the lease.
The right-of-use asset is initially measured at cost, which
comprises the initial amount of the lease liabilities adjusted for
any lease payments made at or before the commencement date, plus
any initial costs incurred. The right-of-use assets are
subsequently measured at cost less accumulated depreciation and
impairment losses. The right-of-use assets are from the
commencement date depreciated over the shorter period of lease term
and useful life of the underlying asset. The estimated useful lives
of right-of-use assets are determined on the same basis as those of
property and equipment. In addition, the right-of-use assets are
periodically reduced by impairment losses, if any, and adjusted for
certain remeasurements of the lease liabilities, e.g. revised
discount rate, change in the lease term or change in future lease
payments resulting from a change in an index.
The lease liabilities are initially measured at the present
value of the lease payments that are not paid at the commencement
date, discounted using the interest rate determined by the Group's
borrowing rate.
2019
GBP000
Operating lease commitments disclosed under IAS17
as at 31 December 2018 835
--------
Less low value and short term leases recognised in
a straight-line basis as an expense (42)
--------
Remaining lease commitments discounted using the
Group's incremental borrowing rate as at the date
of initial application 435
Lease Liability recognised ad at 1 January 2019 435
--------
Of which:
--------
Current lease liabilities 87
--------
Non-current lease liabilities 277
--------
The associated right-of-use assets for all leases were measured
at the amount equal to the lease liability.
The recognised right-of-use assets relate to the following types
of assets:
30 June 2019 1 January 2019
GBP000 GBP000
------------- ---------------
Properties 358 435
------------- ---------------
Total right-of-use assets 358 435
------------- ---------------
5. OPERATING LOSS
The Group's operating loss for the year is stated after charging
the following:
6 months 6 months 12 months
to to to
30 June 30 June 31 Dec
2019 2018 2018
(Unaudited) (Unaudited)
GBP'000 GBP'000 GBP'000
License Fees - 176 781
Depreciation 1 6 12
Foreign exchange losses (136) (136) (222)
6. 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
2019 2018 2018
(unaudited) (unaudited)
------------ ------------ ------------
Total comprehensive loss for
the period (GBP'000) (3,634) (3,937) (6,108)
Basic and diluted weighted average
number of shares 126,049,229 126,049,229 127,553,866
Basic and diluted loss per share
- pence (2.9) (3.1) (4.7)
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.
7. PROPERTY, PLANT AND EQUIPMENT
Details of the Groups property, plant and equipment are as
follows:
Furniture IT equipment Total
and fixtures
GBP'000 GBP'000 GBP'000
Cost
At 1 January 2019 12 25 37
Additions - - -
Disposals - - -
At 30 June 2019 12 25 37
Depreciation
At 1 January 2019 7 24 31
Charge in period 1 - 1
At 30 June 2019 8 24 32
Net book value as at 30 June
2019 4 1 5
============== ============= ========
Net book value as at 30 June
2018 8 4 12
============== ============= ========
Net book value as at 31 December
2018 5 1 6
8. Trade and other receivables
(unaudited) (unaudited)
30 June 30 June 31 Dec
2019 2018 2018
GBP'000 GBP'000 GBP'000
------------ ------------ --------
Trade and other receivables 84 33 195
Related party receivable 150 -- 20
Prepayments 11 20 33
------------ ------------ --------
245 53 248
9. 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.
30 June 31 December
2019 2018
(unaudited)
Weighted Options Weighted Options
Average ('000) Average ('000)
exercise exercise
price price
(pence) (pence)
Outstanding at 1 January 84 18,617 93 10,717
Granted - - 82 9,500
Cancelled - - - -
Forfeited (46) (1,480) (172) (1,600)
Outstanding at period
end 88 17,137 84 18,617
========== ======== ========== ========
Exercisable at period
end 39 3,831 39 5,236
========== ======== ========== ========
No options were exercised during the period to 30 June 2019.
The total outstanding fair value of the share option instruments
is deemed to be approximately GBP4,483,621 as at 30 June 2019.
(2018: GBP6,486,110).
The Company has used the Black-Scholes option pricing model to
estimate the fair value of the options applying the assumptions
below.
Historical volatility relies in part on the historical
volatility of a group of peer companies that management believes is
generally comparable to the Company.
The Company has not paid any dividends on common stock since its
inception and does not anticipate paying dividends on its common
stock in the foreseeable future.
The Company has estimated a forfeiture rate of zero.
For the options issued with a market condition attached, the
Directors have used the Monte Carlo simulation to estimate the fair
value of these options, the Company uses the following methods to
determine its underlying assumptions:
-- expected volatilities are based on the historical volatilities of the market;
-- the expected term of the awards is based on managements'
assessment of when the market condition is likely to be achieved of
15 years; and
-- a range of fair value's per share were produced and
management have determined the most appropriate value based on
their knowledge of the market and vesting conditions being
fulfilled.
Warrants
On 2 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 31 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 11 November 2017, warrants were granted over 100,000 shares
at an exercise price of GBP1.60 per share in lieu of fundraising
fees. The warrants are exercisable until 20 November 2022.
On 11 December 2017, warrants were granted over 183,333 shares
at an exercise price of GBP1.60 per share in lieu of fundraising
fees. The warrants are exercisable until 11 December 2023.
On 15 December 2017, warrants were granted over 196,667 shares
at an exercise price of GBP1.60 per share in lieu of fundraising
fees. The warrants are exercisable until 15 December 2023.
On 15 January 2018, warrants were granted over 163,334 shares at
an exercise price of GBP1.60 per share in lieu of fundraising fees.
The warrants are exercisable until 15 January 2024.
On 22 January 2018, warrants were granted over 80,000 shares at
an exercise price of GBP1.60 per share in lieu of fundraising fees.
The warrants are exercisable until 22 January 2024.
On 5 March 2018, warrants were granted over 78,000 shares at an
exercise price of GBP1.60 per share in lieu of fundraising fees.
The warrants are exercisable until 5 March 2024.
On 19 April 2018, warrants were granted over 51,563 shares at an
exercise price of GBP0.8 per share in lieu of fundraising fees. The
warrants are exercisable until 19 April 2024.
The Directors have estimated the fair value of the warrants in
services provided using an appropriate valuation model. The
remaining fair value of the warrant instruments is deemed to be
approximately GBP638,000. For each set of warrants, the charge has
been expensed over the vesting period. A share based payment charge
for the six months to June 30, 2019 of GBP63k (six months to June
2018: GBP66k) has been expensed in the statement of comprehensive
income.
10. 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 2019 is;
Planwise Convertible
Loan Note
2019
GBP000
-----------------------
Convertible loan notes issued 200
Accrued interest 47
-----------------------
247
=======================
11. Trade and other payables
(unaudited) (unaudited) 12 months
to
30 June 30 June 31 Dec
2019 2018 2018
GBP'000 GBP'000 GBP'000
------------ ------------ ----------
Convertible loan note liability 247 238 243
Trade and other payables 3,286 3,400 2,859
Accruals 795 493 1,813
Related party payable 399 -- 110
Other creditors -- -- --
4,727 4,131 5,025
12. Post balance sheet events
On 22 July 2019, the Group announced the preliminary topline
clinical data from a Phase 2a trial of Milciclib as a monotherapy
in patients with advanced hepatocellular carcinoma (HCC), the most
common form of liver cancer. The primary endpoint of the study was
overall safety. Under compassionate use, a few patients continued
with total treatment for up to 16 months. Overall, treatment with
Milciclib was well-tolerated and no drug-related deaths were
recorded. Secondary endpoints of efficacy including
progression-free survival (PFS) and time to progression (TTP) are
currently being evaluated and will subsequently be reported.
On 6 August 2019, the Group announced the commencement of an
underwritten public offering in the United States of American
Depositary Shares, representing ordinary shares of nominal value
GBP0.03 each in the capital of the Company on the NASDAQ Global
Market. There can be no assurance as to whether or when the
Offering may be completed, or as to the actual size or terms of the
Offering. The price for the Offering has not yet been
determined.
On 4 September 2019, the Group announced additional positive
Phase 2a clinical data exhibiting impressive clinical activity of
Milciclib monotherapy in patients with advanced Sorafenib-resistant
or -intolerant patients with unresectable or metastatic
hepatocellular carcinoma (HCC).
On 1 September 2019, the Group reported its Phase 1 clinical
data demonstrating that nasally administered Foralumab, was
well-tolerated at all doses. Importantly, the treatment showed
significant positive effects on the biomarkers for activation of
mucosal immunity, which is capable of inducing site-targeted
immunomodulation to elicit anti-inflammatory effects.
On 16 September 2019, the Group announced that the U.S. Food and
Drug Administration (FDA) has allowed the initiation of a Phase I
clinical trial in healthy volunteers using a novel oral
enteric-coated capsule formulation of Foralumab, a fully human
monoclonal antibody (mAb), in collaboration with the Brigham and
Women's Hospital (BWH), Harvard Medical School, Boston, MA. This is
the first clinical trial in which Foralumab will be administered
orally to healthy subjects. The objective is to develop orally
administered Foralumab for treatment of autoimmune and inflammatory
diseases.
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
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of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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