Tiziana Life Sci PLC - Half-year Report
("Tiziana" or "the Company")
Interim Results for the Six Months Ended
Advancing pipeline of next generation therapeutics and diagnostics for oncology and immune diseases of high unmet need
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
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 multiple sclerosis, 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
An enteric-coated capsule formulation has been developed for oral administration of Foralumab. cGMP manufacturing of clinical trial materials for a Phase 1 study has been completed. The Phase 1 clinical trial for Foralumab in healthy volunteers was a single-center, single-arm, ascending dose study in which low doses (1.25, 2.5 and 5.0 mg/dose) of Foralumab and placebo were orally administered. The primary endpoint of the Phase 1 study was safety and tolerability of oral Foralumab in humans. The Phase 1 trial was initiated on
Anti IL-6R mAb
TZLS-501, formerly NI-1201
TZLS-501 is a fully human engineered mAb targeting the interleukin-6 receptor (IL-6R).
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.).
On
The treatment utilizes a novel mode of administrationusing hand-held nebulizer to deliver aerosolized anti-IL6R mAb solution to inflamed tissue of deep lung. On
Work at
In
In
ITR Laboratories Canada specializes in inhalation toxicology studies in primates and will start inhalation safety toxicology studies in Cynomolgous monkeys in
The Company is actively evaluating alternative, non-parenteral routes of monoclonal antibody (mAb) administration, namely oral, nasal and inhalation routes, to facilitate topical or local therapeutic action.
Milciclib
TZLS-201
Milciclib, Tiziana's lead small molecule drug, was exclusively licenced in
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.
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. 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
The Phase 2a trial was completed in
On
StemPrintER™
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.
On
Intellectual Property
· On April 24.2020 the Company announced that it has acquired all of the intellectual property relating to a nanoparticle-based formulation of Actinomycin D (Act D; a.k.a. Dactinomycin), from Rasna Therapeutics, Inc for potential use as a treatment for Coronavirus infection.
· On
· Three US Patent Applications filed in the reporting period:
o IL-6 Antibodies for the treatment of Coronavirus (COVID-19; No. 62/987,837 filed
o IL-6/IL-6R Antibodies to treat Coronavirus (No. 63/006,612 filed
o Composition of IL-6/IL-6R antibodies and Dactinomycin and methods of use thereof (No. 63/014,800 filed
Highlights post period:
· Three US Patents were issued in
o Patent No. 10,759,858 B2: Use and methods of treatment of Crohn's disease with Foralumab (Tiziana Press Release
o Patent No. 10,758,541 B2: Use of Milciclib in Combination with Tyrosine Kinase Inhibitors for Treatment of Hepatocellular Carcinoma and other Cancers (Tiziana Press Release
o Patent No. 10,759,862 B2: Methods and Use of Anti-IL-6/IL-6 receptor mAbs as Prophylactic and Therapeutic Interventions for Covid-19 and other pulmonary diseases (Tiziana Press Release
· Two US Patent Applications were filed:
o CD-3 Antibodies for the treatment of Coronavirus (No. 63/058,978 filed
o Composition and methods for augmenting chimeric antigen receptor (CAR) T cell therapies (No. 63/058,783 filed
· On
FINANCIAL
· For the six months to
· The Group ended the period with
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.
Contacts:
|
+44 (0)20 7495 2379 |
|
+44 (0)20 7213 0880 |
|
+44 (0)20 3981 4173 |
About
EXECUTIVE CHAIRMAN'S STATEMENT
I am pleased to report on the Group's financial results for the six months ended
Background
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.
Financial summary
The Group has made a loss for the six months to
The Group ended the period with
Fund raising
During the six months to
The Company also successfully raised
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
Research is planned to extend the intellectual property on our innovative lyophilized foralumab antibody powder in enteric-coated capsule platform technology to other anti-TNF monoclonal antibodies, namely adalimumab (Humira®) and infliximab (Remicade®), as well as anti-IL6R mAb (TZLS-501).
Additionally, lyophilized antibody powder of adalimumab will be tested for efficacy in a validated mouse IBD model.
A pre-clinical study highlighting synergistic anti-HCC effect of milciclib in combination with tyrosine kinase inhibitor such as sorafenib was submitted and accepted for publication in the
COVID-19
We remain cognisant of the potential impact of coronavirus (COVID-19) on our operations and have taken the steps necessary to maintain the integrity of the Company's assets and the health and wellbeing of our employees. The Company is well financed, resilient and well positioned to weather any financial downturn occurring as a result of the outbreak. Indeed, the Company has raised additional funds of
We are also aware of the responsibility we have as a member of the global healthcare community and are developing investigational new technology to treat COVID-19 infections.
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.
Tiziana is set to sponsor a Phase II nasal foralumab trial in Secondary Progressive MS Patients treated with Ocrevus (ocrelizumab). Clinical protocol for Phase 2 nasal clinical trial has been finalized and submitted to the FDA along with the Briefing package on
The Company is working with investigators in Brazil who will conduct a clinical trial in COVID-19 patients with nasally-administered Foralumab to evaluate its ability to suppress inflammation in the nasal and respiratory tract, the primary sites of Covid-19 induced inflamation. In view of the importance and urgency to develop an effective therapy for COVID-19 immediately, the Company, scientists at the
Upon successful completion of Phase I trial in healthy volunteers using our novel oral enteric-coated capsule formulation of Foralumab, Tiziana is in discussion with CROs to design and conduct a Phase II clinical trial in moderate to severe Crohn's disease patients with orally administered foralumab.
Tiziana has expedited its clinical development plan for its anti-Interleukin-6-Receptor (TZLS-501), a fully human monoclonal antibody, for the treatment of COVID-19 patients. Since
Looking ahead, Tiziana is confident that it is well positioned to advance these programs to their next respective value inflection points.
Executive Chairman
Consolidated Statement of Comprehensive Income for the six months ended
|
|
|
|||
|
|
6 months to 30 June |
Restated 6 months to 30 June |
12 months to 31 Dec |
|
|
|
2020 |
2019 |
2019 |
|
|
|
£'000 |
£'000 |
£'000 |
|
|
Notes |
(unaudited) |
(unaudited) |
|
|
|
|
|
|
|
|
Research and development |
|
(760) |
(1,507) |
(2,910) |
|
Operating expenses |
|
(3,169) |
(2,138) |
(4,864) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(3,929) |
(3,645) |
(7,774) |
|
|
|
|
|
|
|
Financial income |
12 |
- |
- |
1 |
|
Finance expense |
12 |
(5) |
(5) |
(73) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss before taxation |
5 |
(3,934) |
(3,650) |
(7,846) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Taxation |
|
- |
27 |
540 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss after taxation |
|
(3,934) |
(3,623) |
(7,306) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the period attributable to equity owners |
|
(3,934) |
(3,623) |
(7,306) |
|
|
|
|
|
|
|
Other comprehensive income for the period |
|
23 |
52 |
129 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss attributable to equity owners
|
|
(3,911) |
(3,571) |
(7,177) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share (pence) |
|
|
|
|
|
Basic and diluted loss per share on continuing operations |
6 |
(2.6p) |
(2.6p) |
(5.4p) |
|
Total basic and diluted loss per share |
|
(2.6p) |
(2.6p) |
(5.4p) |
|
Consolidated Statement of Financial Position as at
|
|
|
|
|||
|
|
30 June |
Restated 30 June |
31 Dec |
||
|
|
2020 |
2019 |
2019 |
||
|
|
£'000 |
£'000 |
£'000 |
||
|
Notes |
(unaudited) |
(unaudited) |
|
||
|
|
|
|
|
||
Assets |
|
|
|
|
||
Non-Current assets: Property, plant and equipment |
7 |
5 |
5 |
5 |
||
Finance lease receivable |
|
236 |
- |
113 |
||
Right-of-use assets |
|
308 |
358 |
329 |
||
Other non-current assets |
|
217 |
217 |
217 |
||
Total Non-current assets |
|
766 |
580 |
664 |
||
|
|
|
|
|
||
Current assets: |
|
|
|
|
||
Trade and other receivables |
8 |
2,013 |
245 |
478 |
||
Taxation receivable |
|
513 |
827 |
513 |
||
Cash and cash equivalents |
|
7,200 |
445 |
153 |
||
Total current assets |
|
9,726 |
1,517 |
1,144 |
||
|
|
|
|
|
||
|
|
|
|
|
||
Total assets |
|
10,492 |
2,097 |
1,808 |
||
|
|
|
|
|
||
Equity and liabilities |
|
|
|
|
||
|
9
|
4,992 38,390 4,806 1,265 31,183 (28,286) (78) (47,330)
|
4,094 25,120 3,021 1,398 31,183 (28,286) (61) (39,463)
|
4,099 25,194 5,662 1,099 31,183 (28,286) 15 (43,146)
|
||
Equity attributed to the owners of the Company
|
|
4,942 |
(2,994) |
(4,180) |
||
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
||
Trade and other payables |
11 |
4,597 |
4,727 |
4,851 |
||
Lease liabilities |
|
322 |
87 |
212 |
||
Related party payable |
|
323 |
- |
451 |
||
Other liabilities |
|
- |
- |
63 |
||
|
|
5,242 |
4,814 |
5,577 |
||
Long term liabilities: |
|
|
|
|
||
Lease Liabilities - non-current |
|
308 |
277 |
411 |
||
|
|
|
|
|
||
Total Liabilities |
|
5,550 |
5,091 |
5,988 |
||
|
|
|
|
|
Total Equity and Liabilities |
|
10,492 |
2,097 |
1,808 |
Consolidated Statement of Cash Flows for the 6 months ended 30 June 2020
|
|
|
|
|
6 months to 30 June |
Restated 6 months to 30 June |
12 months to 31 Dec |
|
2020 |
2019 |
2019 |
|
£'000 |
£'000 |
£'000 |
|
(unaudited) |
(unaudited) |
|
|
|
|
|
Cash flows from operating activities |
|
|
|
|
|
|
|
Total comprehensive loss for the period before tax |
(3,934) |
(3,650) |
(7,846) |
Convertible loan interest |
215 |
5 |
39 |
Loss on disposal of right of use asset |
- |
- |
56 |
Amorisation of right of use asset |
21 |
- |
- |
Shares issued in lieu of fees |
- |
- |
82 |
Share based payment - options |
979 |
164 |
992 |
Issue of share capital (Loan conversion) |
(190) |
- |
- |
Cancellation of options |
(23) |
- |
- |
Share based payment - warrants |
310 |
- |
- |
Net (increase) / decrease in operating assets -Trade / other receivables |
(1,894) |
3 |
(100) |
Net increase / (decrease) in operating liabilities -Trade / other liabilities Depreciation Loss on foreign exchange
|
(445) 2 (105)
|
(307) 7 56 |
325 198 129
|
Net cash used in operating activities
Cash inflow from taxation
Net cash used in operating activities
Cash flow from financing activities Proceeds from issuance of ordinary shares Proceeds from issuance of warrants Proceeds from issuance of options Cost of fundraising Repayment of leasing liabilities Net cash generated from financing activities
Cash flows from investing activites Acquisition of property, plant and equipment Acquisition of other investments Net cash outflow from investing activities
Net increase / (decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period |
(5,068)
-
(5,064)
10,899 1,940 91 (824) 7 12,113
(2) - (2)
7,047
153
7,200 |
(3,722)
-
(3,722)
2 - -
- 2
- - -
(3,720)
4,165
445 |
(6,125)
800
(5,325)
- 1,473 -
(157) 1,316
(3)
(3)
(4,012)
4,165
153 |
Consolidated Statement of Changes in Equity
for the six months ending 30 June 2020 and restated 30 June 2019
(Unaudited) |
Share Capital
|
Share Premium |
Share Based Payment Reserve |
Warrants |
CLN Reserve |
Capital Reduction Reserve |
Translation Reserve |
Other Reserve |
Retained Earnings |
Total Equity |
|
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
|
|
|
|
|
|
|
||||
Balance at 1 January 2020 |
4,099 |
25,194 |
3,850 |
1,812 |
1,099 |
31,183 |
15 |
(28,286) |
(43,146) |
(4,180) |
Transactions with owners |
|
|
|
|
|
|
|
|
|
|
Issue of share capital (Fundraise & ATM)
|
598 |
10,301 |
- |
- |
- |
- |
- |
- |
- |
10,899 |
Cost of fundraising |
- |
(824) |
|
|
|
|
|
|
|
(824) |
Issue of share capital (Warrants)
|
150 |
2,503 |
- |
- |
- |
- |
- |
- |
- |
2,653 |
Issue of share capital (Loan conversion) |
132 |
1,137 |
-
|
- |
(1,459) |
- |
- |
- |
- |
(190) |
Issue of share capital (Options) |
13 |
78 |
- |
- |
- |
- |
- |
- |
- |
90 |
Converitble loan note interest |
- |
- |
- |
- |
216 |
- |
- |
- |
(216) |
- |
Share based payments (options)
|
- |
- |
979 |
- |
- |
- |
- |
- |
- |
979 |
Share based payments (warrants)
|
- |
- |
- |
(473) |
70 |
- |
- |
- |
- |
(402) |
Forfeiture of options |
- |
- |
(22) |
- |
- |
- |
- |
- |
- |
(22) |
|
|
|
|
|
|
|
|
|
|
|
Total transactions with owners |
893 |
13,196 |
956 |
(473) |
(1,173) |
- |
- |
- |
(216) |
13,183 |
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
Loss for the period |
- |
- |
- |
- |
- |
- |
- |
- |
(3,934) |
(3,934) |
Foreign currency translation |
- |
- |
- |
- |
- |
- |
(105) |
- |
- |
(105) |
Loss on disposal of asset |
- |
- |
- |
- |
- |
- |
- |
- |
(34) |
(34) |
OCI-FX |
- |
- |
- |
- |
- |
- |
12 |
- |
- |
12 |
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income |
- |
- |
- |
- |
- |
- |
(93) |
- |
(4,184) |
(4,061)
|
Balance at 30 June 2020 |
4,992 |
38,390 |
4,806 |
1,339 |
(74) |
31,183 |
(78) |
(28,286) |
(47,330) |
4,942 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
Share Capital
|
Share Premium |
Capital Reduction Reserve |
Share Based Payment Reserve |
Shares to Be Issued Reserve (warrants |
Other Reserve |
Translation Reserve |
Retained Earnings |
Total Equity |
|
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
|
|
|
|
|
|
|
|||
Balance as at 1 January 2019 |
4,094 |
25,894 |
31,183 |
2,857 |
548 |
(28,286) |
(113) |
(35,766) |
411 |
|
|
|
|
|
|
|
|
|
|
Prioer period adjustment |
- |
(777) |
- |
- |
851 |
- |
- |
(74) |
- |
|
|
|
|
|
|
|
|
|
|
Restated balance at 1 January 2019 |
4,094 |
25,117 |
31,183 |
2,857 |
1,399 |
(28,286) |
(113) |
(35,840) |
411 |
Transactions with owners |
|
|
|
|
|
|
|
|
|
Issue of share capital |
- |
3 |
- |
- |
- |
- |
- |
- |
3 |
Share based payments (options) |
- |
- |
- |
662
|
- |
- |
- |
- |
662 |
Forfeiture of options |
|
|
|
(498) |
- |
|
|
|
(498) |
Share based payments (warrants) |
- |
- |
- |
- |
(1) |
- |
- |
- |
(1) |
|
|
|
|
|
|
|
|
|
|
Total transactions with owners |
- |
3 |
- |
164 |
(1) |
- |
- |
- |
166 |
Comprehensive income |
|
|
|
|
|
|
|
|
|
Loss for the period |
- |
- |
- |
- |
- |
- |
- |
(3,623) |
(3,623) |
Foreign currency translation |
- |
- |
- |
- |
- |
- |
52 |
- |
52 |
|
|
|
|
|
|
|
|
|
|
Total comprehensive income |
- |
- |
- |
- |
- |
- |
52 |
(3,623) |
(3,571)
|
Balance at 30 June 2019 |
4,094 |
25,120 |
31,183 |
3,021 |
1,398 |
(28,286) |
(61) |
(39,463) |
(2,994) |
|
Share Capital |
Share Premium |
Capital Reduction Reserve |
Share Based Payment Reserve |
Shares to Be Issued Reserve (warrants) |
Convertible Loan Note Reserve |
Other reserve |
Translation reserve |
Retained Earnings |
Total Equity |
|
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
£'000 |
|
|
|
|
|
|
|
|
|
|
|
Balance as at 1 January 2019 |
4,094 |
25,894 |
31,183 |
2,857 |
548 |
- |
(28,286) |
(113) |
(35,766) |
411 |
|
|
|
|
|
|
|
|
|
|
|
Prioer period adjustment |
- |
(777) |
- |
- |
851 |
- |
- |
- |
(74) |
- |
|
|
|
|
|
|
|
|
|
|
|
Restated balance as at 1 January 2019 |
4,094 |
25,117 |
31,183 |
2,857 |
1,399 |
- |
(28,286) |
(113) |
(35,840) |
411 |
Transactions with owners |
|
|
|
|
|
|
|
|
|
|
Issue of share capital in lieu of fees |
5 |
77 |
- |
- |
- |
- |
- |
- |
- |
82 |
Convertible loan notes issued |
- |
- |
- |
- |
- |
1,473 |
- |
- |
- |
1,473 |
Convertible loan note interest |
- |
- |
- |
- |
- |
39 |
- |
- |
- |
39 |
Share based payment (options) |
- |
- |
- |
993 |
- |
- |
- |
- |
- |
993 |
Issuance of warrants |
- |
- |
- |
- |
413 |
(413) |
- |
- |
- |
- |
Total transactions with owners |
5 |
77 |
- |
993 |
413 |
1,099 |
- |
- |
- |
2,587 |
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
Exchange differences on translating foreign operations |
- |
- |
- |
- |
- |
- |
- |
128 |
- |
128 |
Loss for the year |
- |
- |
- |
- |
- |
- |
- |
- |
(7,306) |
(7,306) |
Total comprehensive income |
- |
- |
- |
- |
- |
- |
- |
128 |
(7,306) |
(7,178) |
|
- |
|
|
|
|
|
|
|
|
|
Balance as at 31 December 2019 |
4,099 |
25,194 |
31,183 |
3,850 |
1,812 |
1,099 |
(28,286) |
15 |
(43,146) |
(4,180) |
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 (£'000) which is the functional currency of the primary economic environment in which the Company operates.
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 2019 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 2019 included within this report does not constitute the full statutory Annual Report for that period.
As permitted by section 408 of the Companies Act 2006, a separate profit and loss account for the Company has not been presented in these financial statements.
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 2020
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. 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 £1.
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 bases of assets and liabilities and their carrying amounts in the consolidated financial statements. Deferred tax is determined using tax rates (and laws) that have been enacted or substantially enacted by the balance sheet date and expected to apply when the related deferred tax is realized, or the deferred liability is settled. Deferred tax assets are recognized to the extent that it is probable that the future taxable profit will be available against which the temporary differences can be utilized.
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.
License fees
Payments related to the acquisition of rights to a product or technology are capitalised as intangible assets if it is probable that future economic benefits from the asset will flow to the entity and the cost of the asset can be reliably measured.
Payments made which provide the right to perform research are carefully evaluated to determine whether such payments are to fund research or acquire an asset. Licence fees expenses are recognised as incurred.
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.
Warrants
Warrants issued by the Group to investors as part of a share subscription are compound financial instruments
where the warrant meets the definition of a financial liability.
The financial liability component is initially measured at fair value in the Consolidated Statement of Financial
Position. Equity is measured at the residual between the subscription price for the entire instrument and the
liability component. The financial liability component is remeasured depending on its classification. Equity is not remeasured.
Investments
Investments are held as non-current assets and comprise investments in subsidiary undertakings and are stated at cost less provision for any impairment.
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.
(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.
Fixtures and fittings 5 years
IT and equipment 3 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 £833k and a lease liability of £833k 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 - options, in the case of options/warrants awarded to employees, directors, advisers and other consultants.
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 non- 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
Where there is no option to repay in cash or the Company has the choice of settlement, 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, for which there is no obligation to settle in cash, 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 the above conditions are not met
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 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.
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.
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. Accounting for Warrants - Prior period adjustment
During the year, the Group reviewed its accounting treatment for warrants. The Group has warrants that had been issued in lieu of fees and warrants that had been issued as an additional incentive for investors to enter into a Convertible Loan Note agreement.
Warrants issued in lieu of fees
In prior years the fair value at date of grant had been expensed to the Statement of Income based on the vesting period of the warrant. The Group recognises that the fair value at the date of grant should be recognised over the life of the service for which the warrant was provided.
Warrants issued as incentive
In prior years the fair value at date of grant had been expensed to the Statement of Income based on the vesting period of the warrant. The Group recognises that the fair value of the warrants should be recognised as a cost of fundraising and fully recognised at the date of issuance of the Convertible Loan Note.
The adjustments have impacted the prior period and earlier periods and the impact on the financial statements is as follows:
|
1 January 2019 |
Adjustment |
1 January 2019 |
|
Consolidated Balance Sheet (Extract) |
£'000 |
£'000 |
£'000 (Restated) |
|
|
|
|
|
|
Share Premium |
25,894 |
(777) |
25,117 |
|
Share based payment reserve (warrants)
|
548 |
851 |
1,399 |
|
Retained Earnings
|
(35,766) |
(74) |
(35,840) |
|
|
|
|
|
|
Total Equity |
411 |
- |
411 |
|
|
|
|
|
|
|
30 June 2019 |
Adjustment |
30 June 2019 |
|
Consolidated Balance Sheet (Extract) |
£'000 |
£'000 |
£'000 (Restated) |
|
|
|
|
|
|
Share Premium |
25,897 |
(777) |
25,120 |
|
Share based payment reserve (warrants)
|
611 |
787 |
1,398 |
|
Retained Earnings
|
(39,453) |
(10) |
(39,463) |
|
|
|
|
|
|
Share Total Equity |
(2,993) |
- |
(2,993) |
|
|
|
|
|
|
|
30 June 2019 |
Adjustment |
30 June 2019 |
|
Consolidated Statement of Comprehensive Income (Extract) |
£'000 |
£'000 |
£'000 (Restated) |
|
|
|
|
|
|
Operating Expenses |
(2,201) |
63
|
(2,138) |
|
|
|
|
|
|
Loss before taxation |
(3,713) |
63 |
(3,650) |
|
5. OPERATING LOSS
The Group's operating loss for the year is stated after charging the following:
|
6 months to 30 June 2020 |
Restated 6 months to 30 June 2019 |
12 months to 31 Dec 2019 |
|
(Unaudited) |
(Unaudited) |
|
|
£'000 |
£'000 |
£'000 |
|
|
|
|
License Fees |
- |
- |
433 |
Depreciation of Property, Plant and Equipment |
2 |
7 |
4 |
Depreciation (Right-of-use asset) |
33 |
194 |
192 |
Foreign exchange losses |
(128) |
(136) |
129 |
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 to 30 June |
Restated 6 months to 30 June |
12 months to 31 Dec |
|
2020 |
2019 |
2019 |
|
|
|
|
|
(unaudited) |
(unaudited) |
|
|
|
|
|
Total comprehensive loss for the period (£'000) |
(3,911) |
(3,623) |
(7,306) |
|
|
|
|
Basic and diluted weighted average number of shares |
150,224,119 |
136,463,818 |
136,482,627 |
|
|
|
|
Basic and diluted loss per share - pence |
(2.6) |
(2.6) |
(5.4) |
|
|
|
|
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 and fixtures |
|
|
IT equipment |
|
Total |
|
|
£'000 |
|
|
£'000 |
|
£'000 |
Cost |
|
|
|
|
|
|
|
At 1 January 2020 |
|
12 |
|
|
28 |
|
40 |
Additions |
|
1 |
|
|
2 |
|
3 |
Disposals |
|
- |
|
|
- |
|
- |
|
|
|
|
|
|
|
|
At 30 June 2020 |
|
13 |
|
|
30 |
|
43 |
|
|
|
|
|
|
|
|
Depreciation |
|
|
|
|
|
|
|
At 1 January 2020 |
|
9 |
|
|
26 |
|
35 |
Charge in period |
|
2 |
|
|
1 |
|
3 |
|
|
|
|
|
|
|
|
At 30 June 2020 |
|
11 |
|
|
27 |
|
39 |
|
|
|
|
|
|
|
|
Net book value as at 30 June 2020 |
|
2 |
|
|
3 |
|
5 |
|
|
|
|
|
|
|
|
Net book value as at 30 June 2019 |
|
4 |
|
|
1 |
|
5 |
|
|
|
|
|
|
|
|
Net book value as at 31 December 2019 |
|
3 |
|
|
2 |
|
5 |
|
|
|
|
|
|
|
|
8. Trade and other receivables
|
(unaudited) 30 June 2019 |
Restated (unaudited) 30 June 2019 |
31 Dec 2019 |
|
£'000 |
£'000 |
£'000 |
|
|
|
|
Trade and other receivables |
1,011 |
84 |
212 |
Related party receivable |
609 |
150 |
245 |
Prepayments |
393 |
11 |
21 |
|
2,013 |
245 |
478 |
|
|
|
|
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.
At the General Meeting held on May 6th, 2020, a resolution was passed to reprice existing share options to employees and directors. The Remuneration Committee, comprising the two independent non-executive directors were asked by the Board to review the current awards outstanding and make recommendations to the Board. The Company's share price has seen some significant spikes reflecting investor reaction to the work of the staff and executive team in identifying new opportunities and the Remuneration Committee was keen that, given the original timing of its remit, that it was able to take the "undisturbed" share price into account in reaching a fair result.
The conclusions of the Remuneration Committee were that the only sensible way in which to address the situation was that (i) all existing options held by the relevant individuals (including all non-managerial staff staff members) be surrendered and new options be granted; (ii) the new options to reflect an immediate vesting percentage equal to the vested element of the old awards; but (iii) the new options to be subject to strict criteria on any sale of shares arising from awards for two years post the relevant vesting dates; and (iv) all vested element of such awards to be subject to claw-back in the event that the recipient ceased to be a director or employee within two years of the award being made. The same terms to be applied to all directors and employees holding option awards. The Remuneration Committee selected an exercise price of 35p per share (which was above the average prevailing share price in January 2020, February 2020 and early March 2020 and above the actual share price in late March following the fundraise. 11,409,403 options were repriced and these have all been treated as option modifictions.
|
|
June 2020 |
|
June 2019 |
||||
|
|
Options ('000) |
|
Weighted Average exercise price (pence) |
|
Options ('000) |
|
Weighted Average exercise price (pence) |
|
|
|
|
|
|
|
|
|
Outstanding at 1 January |
|
16,379 |
|
86 |
|
18,617 |
|
84 |
Granted |
|
2,370 |
|
35 |
|
- |
|
- |
Forfeited |
|
(50) |
|
(160) |
|
(1,480) |
|
(46) |
Exercised |
|
(420) |
|
(23) |
|
|
|
|
Cancelled |
|
- |
|
- |
|
- |
|
- |
|
|
|
|
|
|
|
|
|
Outstanding at 31 December |
|
18,279 |
|
59 |
|
17,137 |
|
88 |
|
|
|
|
|
|
|
|
|
Exercisable at 31 December |
|
5,521 |
|
32 |
|
5,236 |
|
39 |
420,000 options were exercised during the period to June 30 2020.
The total outstanding fair value charge of the share option instruments is deemed to be approximately £4,755k (2019: £4,484k).
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 2nd March 2015, warrants were granted over 600,000 shares at an exercise price of £0.50 per share in lieu of the issue of options. The warrants are exercisable until 31 December 2021.
On 31st May 2015, warrants were granted over 292,500 shares at an exercise price of £0.66 per share in lieu of fundraising fees. The warrants are exercisable until 31 May 2022.
On 11th November 2017, warrants were granted over 100,000 shares at an exercise price of £1.60 per share in conjunction with a Convertible Loan Note. The warrants are exercisable until 20 November 2022.
On 11th December 2017, warrants were granted over 183,333 shares at an exercise price of £1.60 per share in conjunction with a Convertible Loan Note. The warrants are exercisable until 11 December 2023.
On 15th December 2017, warrants were granted over 196,667 shares at an exercise price of £1.60 per share in conjunction with a Convertible Loan Note. The warrants are exercisable until 15 December 2023.
On 16th January 2018, warrants were granted over 63,334 shares at an exercise price of £1.60 per share in lieu of fundraising fees. The warrants are exercisable until 15 January 2024.
On 22nd January 2018, warrants were granted over 133,333 shares at an exercise price of £1.60 per share in conjunction with a Convertible Loan Note. The warrants are exercisable until 22 January 2024.
On 5th March 2018, warrants were granted over 78,000 shares at an exercise price of £1.60 per share in lieu of fundraising fees. The warrants are exercisable until 5 March 2024.
On 19th April 2018, warrants were granted over 51,563 shares at an exercise price of £0.8 per share in lieu of fundraising fees. The warrants are exercisable until 19 April 2024.
On 28th November 2018, warrants were granted over 185,000 shares at an exercise price of £0.8 per share in lieu connection with the issuance and conversion of a loan. The warrants are exercisable until 27 November 2023.
On 28th November 2018, warrants were granted over 150,000 shares at an exercise price of £0.8 per share in connection with the issuance and conversion of a loan. The warrants are exercisable until 27 November 2023.
On 31st October 2019, warrants were granted over 185,950 shares at an exercise price of £0.42 per share in in lieu of fundraising fees. The warrants are exercisable until 31 October 2024. In January 2020, an additional 256,788 warrants were granted with the same terms.
On 31st October 2019, warrants were granted over 1,289,372 shares at an exercise price of £0.42 per share in connection with the issuance of a convertible loan note. The warrants are exercisable until 31 October 2024. In January 2020, an additional 1,780,562 warrants were granted with the same terms.
On 21st January 2020, warrants were granted over 285,714 shares at an exercise price of £0.35 per share in in lieu of fundraising fees. The warrants are exercisable until 21 Janaury 2023.
As disclosed in Note 3, the Group has made an adjustment to its accounting treatment of warrants this year.
The Directors have estimated the fair value of the warrants in services provided using the Black-Scholes valuation model and assumptions above.
|
|
2020 |
2019 |
2018 |
2017 |
2015 |
|
|
|
|
|
|
|
Weighted average share price |
|
£0.35 |
£0.42 |
£0.67 |
£1.60 |
£0.55 |
For each set of warrants, the charge has been expensed over the service period. A share-based payment charge for the year of £nil (2019 restated: £nil) 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 £200,000 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 £0.10 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 2020 is;
|
Planwise Convertible Loan Note 2020 |
|
Planwise Convertible Loan Note 2019 |
|
£000 |
|
£000 |
Convertible loan notes issued |
200 |
|
200 |
Accrued interest |
52 |
|
47 |
|
|
|
|
|
252 |
|
247 |
11. Trade and other payables
|
(unaudited) 30 June 2020 |
Retsated (unaudited) 30 June 2019 |
12 months to 31 Dec 2019 |
|
£'000 |
£'000 |
£'000 |
|
|
|
|
Convertible loan note liability |
252 |
247 |
- |
Trade and other payables |
2,604 |
3,286 |
3,178 |
Accruals |
1,741 |
795 |
1,673 |
Related party payable |
-- |
399 |
451 |
|
4,597 |
4,727 |
5,302 |
|
|
|
|
12. Finance income and costs
|
(unaudited) 30 June 2020 |
Restated (unaudited) 30 June 2019 |
12 months to 31 Dec 2019 |
|
£'000 |
£'000 |
£'000 |
|
|
|
|
Finance Income
|
|
|
|
Finance income received on net investment in lease |
-- |
-- |
1 |
Finance Expenses
|
-- |
-- |
-- |
Finance charge accrued on convertible loan notes |
-- |
-- |
49 |
Interest expense on lease liabilities |
5 |
5 |
24
|
|
5 |
5 |
73
|
|
5 |
5 |
72 |
|
|
|
|
13. FINANCE LEASE RECEIVABLES
In November 2019, the Group subleased one of its leased office spaces. The sublease has been classified as a finance lease receivable.
|
(unaudited) 30 June 2020 |
Restated (unaudited) 30 June 2019 |
12 months to 31 Dec 2019 |
|
£'000 |
£'000 |
£'000 |
|
|
|
|
Current |
-- |
-- |
-- |
Non-current |
236 |
-- |
113 |
|
236 |
-- |
113 |
|
|
|
|
The undiscounted lease payments to be received over the next 5 years are as follows:
|
1 Year |
2 years |
3 or more years |
|
£000 |
£000 |
£000 |
|
|
|
|
Undiscounted lease payments receivable |
145 |
49 |
- |
|
|
|
|
|
|
|
|
|
145 |
49 |
- |
The undiscounted lease payments do not include a discount factor charge of £5k.
During the six months to June 30, 2020, the Group received £46k of income from its subleasing activities.
Finance Lease Receivable |
30 June 2020 |
|
£000 |
|
|
Finance Lease receivable as at 1 Jan 2020 |
236 |
Sublease income |
(46) |
|
|
|
|
|
190 |
14. LEASES
All leases are accounted for by recognising a right-of-use asset and a lease liability except for:
· Leases of low value assets; and
· Leases with a duration of 12 months or less.
IFRS16 was adopted 1 January 2019 without restatement of comparative figures. The following policies apply subsequent to the date of initial application, 1 January 2019.
The Group has leases for its offices. Each lease is reflected on the balance sheet as a right-of-use asset and a lease liability. The Group does not have any short-term leases or leases of low value assets. Variable lease payments which do not depend on an index or a rate (such as lease payments based on a percentage of Group sales) are excluded from the initial measurement of the lease liability and asset. The Group classifies its right-of-use assets in a consistent manner to its property, plant and equipment.
For leases over office buildings and factory premises the Group must keep those properties in a good state of repair and return the properties in their original condition at the end of the lease.
During the six months to 30 June 2020, the Group sublet one of its office spaces. This has been recognised as a writeback of the associated right of use asset and the recognition of a finance lease receivable for the value of the sublease.
Right-of-use assets |
|
30 June 2020 |
|
31Dec 2019 |
|
|
|
|
|
|
|
|
|
£000 |
|
£000 |
|
|
|
|
|
|
|
At 1 January |
|
329 |
|
833 |
|
|
|
|
|
|
|
Additions |
|
- |
|
- |
|
|
|
|
|
|
|
Depreciation |
|
(33) |
|
(194) |
|
|
|
|
|
|
|
Finance lease receivable |
|
-- |
|
(249) |
|
|
|
|
|
|
|
Loss on disposal |
|
-- |
|
(56) |
|
|
|
|
|
|
|
Foreign exchange movements |
|
12 |
|
(5) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
308 |
|
329 |
|
|
|
|
|
|
|
|
30 June 2020 |
|
31 Dec 2019 |
|
|
£'000 |
|
£'000 |
|
|
|
|
|
|
Lease Liabilities
|
|
|
|
|
At 1 January 2020 |
623 |
|
833 |
|
Interest expense |
10 |
|
24 |
|
Lease payments |
(94) |
|
(234)
|
|
|
539 |
|
623 |
|
|
|
|
|
|
Lease liabilities are presented in the statement of financial; position as follows:
|
|
30 June 2020 |
|
31 Dec 2019 |
|
|
£000 |
|
£000 |
Current |
|
231 |
|
212 |
Non-current |
|
308 |
|
411 |
|
|
|
|
|
|
|
|
|
|
|
|
539 |
|
623 |
The lease liabilities are secured by the related underlying assets. Future minimum lease payments as at 30 June 2020 were as follows:
|
|
Minimum lease payment due |
||||
|
|
Within 1 year |
1-2 years |
2-5 years |
Over 5 years |
Total |
30 June 2020 |
|
|
|
|
|
|
Lease payments |
|
245 |
134 |
190 |
- |
569 |
Finance Charges |
|
(14) |
(8) |
(8) |
- |
(30) |
Net Present Values |
|
231 |
126 |
182 |
|
539 |
15. Post balance sheet events
On 24 July 2020, the Company announced that it has allotted and issued 88,580 ordinary shares of 3 pence each credited as fully paid in respect of the exercise of 88,580 warrants at a price of 93 pence per share, yielding £82,379 in cash proceeds for the Company.
On 31 July 2020 - the Company announced that during the calendar month of July, it had issued a total of 2,043,000 ordinary shares under the Company's ATM sales agreement (announced on 15 April 2020) to meet sales of a total of 408,600 ADSs under the ATM sales agreement, totaling gross proceeds of $4,371,289.
On 5 August 2020, the Company announced the closing of its registered direct offering of American Depositary Shares ("ADSs") on the NASDAQ Global Market. As of 3 August 2020, the Company issued 11,009,615 ADSs (representing 22,019,230 new ordinary shares of nominal value £0.03 each in the capital of the Company at a price of $5.20 per ADS raising gross proceeds of approximately $57.25 million (before deducting placement agent fees and offering expenses).
On 26 August 2020, the Company, awarded 250,000 options each to Willy Simon and John Brancaccio. The options are exercisable at a price of 147.5 pence per share (being the mid-market closing price of the Company's shares traded on AIM on 25 August 2020). The options will vest over 4 years and in tranches so that each tranche would vest on a standalone or aggregated basis should the total shareholder return in each financial year be equal to, or exceed, 10%, as reported in the annual report and accounts for the Company for the relevant financial year and the first measurement period being in respect of the financial year ended 31 December 2020, with the decision as whether vesting had occurred to be taken on the business day following the publication of the relevant financial results.
On 27 August 2020, the Company, announced that it has allotted and issued 600,000 ordinary shares of 3 pence each credited as fully paid in respect of the exercise of 600,000 warrants at a price of 50 pence share, yielding £300,000 in cash proceeds for the Company.
On 16 September 2020, the Company, announced its plans for demerging its StemPrintER asset into a separate and independently listed public company, Accustem Sciences Limited. The Company will hold a shareholders meeting on October 2, 2020 to vote on the planned demerger. As part of the demerger, Tiziana will provide the new entity with $1.3M in cash. Accustem Sciences intends to list on the London Stock Exchange (LSE) in late Q4 2020, and potentially a dual listing on NASDAQ in 2021. To effect the demerger, Tiziana plans to distribute a 1:1 share dividend to its shareholders with a record date of 0700 London time on October 30, 2020.
On 21 September 2020, the Company, announced that it had allotted and issued 281,250 ordinary shares of 3 pence each credited as fully paid at a price of 128 pence per share in respect of agreements reached with scientific advisory board members concerning the commuting of cash fees into equity.
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