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Tiziana Life Sciences plc ("Tiziana" or "the Company") Interim Results for the Six Months Ended 30 June 2021 Advancing pipeline of next generation therapeutics and diagnostics for oncology and immune diseases of high unm

Key Takeaway: Results for the Six Months Ended 30 June 2021 pipeline of next generation therapeutics and diagnostics for oncology and immune diseases of high unmet need 24 September 2021 - Tiziana Life Sciences plc ("Tiziana", LSE: TILS, NASDAQ: TLSA), a biotechnology company a biotechnology

Full Press Release Details

Results for the Six Months Ended 30 June 2021
pipeline of next generation therapeutics and diagnostics for oncology and immune diseases of high unmet need
24 September 2021 - Tiziana Life Sciences plc ("Tiziana", LSE: TILS, NASDAQ: TLSA), a biotechnology company a biotechnology
company focused on innovative therapeutics for oncology, inflammation, and infectious diseases today announces its interim results for
the six months ended 30 June 2021.
Company continues to carefully manage its working capital position and continues the process, as referred to below, to evaluate opportunities
to raise further funds through the issue of additional equity capital.
view the complete Interim Accounts click here: https://ir.tizianalifesciences.com/financial-
information/interim-reports
Tiziana Life Sciences
Life Sciences plc is a dual listed (NASDAQ:TLSA, UK LSE: TILS) biotechnology company that focuses on the discovery and development of
novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to Milciclib, the Company will
be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive
multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody ("mAb") in clinical development in the world.
This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple
sclerosis, type-1 diabetes ("T1D"), inflammatory bowel disease ("IBD"), psoriasis and rheumatoid arthritis, where
modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor ("IL6R")
mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.
CHAIRMAN'S STATEMENT
am pleased to report on the Group's financial results for the six months ended 30 June 2021. We have made strong progress advancing
our pipeline in the first half of the year.
are set to start a Phase 2 clinical trial in Brazil, , treating hospitalized, severe COVID-19 patients with intranasal foralumab, a fully
human anti-CD3 monoclonal antibody. This study, conducted in collaboration with FHI Clinical, will begin enrolling patients in November
2021. This randomized, placebo-controlled, double- blind, proof-of-concept study is designed to expand on the preliminary findings of
safety, tolerability and efficacy of intranasal administration of foralumab observed in mild to moderate non-hospitalized COVID-19 patient
trial that was completed earlier this year.
on positive results from treatment of an Expanded Access (EA) progressive MS patient with intranasal foralumab for three months at Brigham
and Women's Hospital, Boston, MA, we plan to enroll additional EA patients. We are also in discussions with VU Medical Center,
Amsterdam to conduct a Phase 1b, double blind, randomized, placebo-controlled study of intranasal foralumab in primary and secondary
progressive MS subjects.
successful completion of a Phase I trial in healthy volunteers using our novel oral enteric-coated capsule formulation of Foralumab,
Tiziana is collaborating with Parexel CRO to conduct a Phase 1b clinical trial in moderate to severe Crohn's disease patients.
to prepare and has submitted an IND to FDA. The multicenter trial will enroll subjects at US and EU clinical sites in Q4 2021.
are preparing a preIND meeting briefing package to submit to FDA for its anti-Interleukin-6-Receptor (TZLS-501), a fully human monoclonal
antibody, for the treatment of Interstitial lung disease associated with systemic sclerosis (SSc-ILD). We are planning tol submit an
IND by the end of 2021. If approved, we anticipate to initiate a Phase 1a, single ascending dose study to evaluate the safety and pharmacokinetics
of TZLS-501 in healthy volunteers in Q1 2022.
ahead, Tiziana is confident that it is well positioned to advance these programs to their next respective value inflection points.
Consolidated Statement of Comprehensive Income
months ended 30 June 2021
6 months 6 months 12 months
to 30 June to 30 June To 31 Dec
2021 2020 2020
'000 '000 '000
(Unaudited) (Unaudited)
Research and development (4,355 ) (760 ) (4,667 )
Operating expenses (8,214 ) (3,169 ) (8,724 )
Realisation bonus - - (10,290 )
Impairment of asset - - (217 )
Gain on disposal of Intellectual Property - - 2,074
Operating loss (12,569 ) (3,929 ) (21,824 )
Financial income - - -
Finance expense (18 ) (5 ) (243 )
Operating loss before taxation (12,587 ) (3,934 ) (22,067 )
Taxation - - 1,719
Operating loss after taxation (12,587 ) (3,934 ) (20,348 )
Net loss for the period attributable to equity owners (12,587 ) (3,934 ) (20,348 )
Other comprehensive income for the period (6 ) 23 186
Total comprehensive loss attributable to equity owners (12,593 ) (3,911 ) (20,162 )
Basic and diluted loss per share (pence)
Basic and diluted loss per share on continuing operations (7.4p ) (2.6p ) (12.0p )
Total basic and diluted loss per share (7.4p ) (2.6p ) (12.0p )
Consolidated Statement of Financial Position
30 June 30 June 31 Dec
2021 2020 2020
'000 '000 '000
(unaudited) (unaudited)
Assets
Non-Current assets:
Property, plant and equipment 15 5 1
Purchase of Act D 97 - 97
Finance lease receivable - - -
Right-of-use assets 406 308 262
Other non-current assets - 217 -
Total Non-current assets 518 530 360
Currents assets:
Prepayments 804 393 276
Finance lease recievable 43 236 111
Related Party Receivable 337 610 270
Other Receivable 372 1,010 300
Taxation receivable 1,250 513 2,232
Cash and cash equivalents 38,605 7,200 48,217
Total current assets 41,411 9,962 51,406
Total assets 41,929 10,492 51,766
Equity and liabilities
Shareholder's equity:
Called up share capital 5,838 4,992 5,838
Share premium 81,227 38,390 81,227
Share based payment reserve 8,484 4,806 6,319
Shares to be issued reserve 474 1,265 475
Capital reduction reserve 31,957 31,183 31,958
Shares to be issued 10,290 - 10,290
Other reserve (28,286 ) (28,286 ) (28,286 )
Translation reserve 208 (78 ) 201
Retained earnings (74,901 ) (47,330 ) (62,313
Equity attributed to the owners of the Company 35,291 4,942 45,709
Current liabilities:
Trade and other payables 4,964 4,597 4,095
Lease liabilities 168 322 195
Related party payable 1,142 323 1,493
Other liabilities 60 - 62
6,334 5,242 5,845
Long term liabilities:
Lease Liabilities - non-current 304 308 212
Total Liabilities 6,638 5,550 6,057
Total Equity and Liabilities 41,929 10,492 51,766
Consolidated Statement of Cash Flows
6 months to 6months to 12 months to
30 June 30 June 31 December
2021 2020 2020
'000 '000 '000
(unaudited) (unaudited )
Cash flows from operating activities
Total comprehensive loss for the period before tax (12,587 ) (3,934 ) (22,067 )
Convertible loan interest - 215 216
Loss on disposal of right of use asset - - -
Amorisation of right of use asset - 21 -
Shares issued in lieu of fees - - 360
Share based payment - options 2,164 979 3,740
Share based payment - warrants - - 20
Options forfeited/cancelled in the year - - (26 )
Bonus to be settled in equity - - 10,290
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 801 (1,894 ) (364 )
Net increase / (decrease) in operating liabilities
-Trade / other liabilities (886 ) (445 ) 135
Depreciation 2 2 4
Depreciation of right of use asset - - 67
Impairment of SharDNA - - 217
Gain from disposalof intellectual property - - (2,074 )
(Gain)/Loss on foreign exchange 6 (105 ) 185
Finance Lease 66 - -
Loss on disposal of right of use asset 54 - -
Net cash used in operating activities (10,380 ) (5,068 ) (9,297 )
Cash inflow from taxation 981 - -
Net cash used in operating activities (9,399 ) (5,064 ) (11,806 )
Cash flow from financing activities
Proceeds from issuance of ordinary shares - 10,899 57,283
Proceeds from issuance of warrants - 1,940 2,682
Proceeds from issuance of options - 91 727
Proceeds from issuance of convertible loan notes - - 120
Cost of fundraising - (824 ) (3,136 )
Repayment of lease liabilities - 7 (216 )
Right of use asset (198 ) - -
Net cash generated from financing activities (198 ) 12,113 57,460
Cash flows from investing activites
Acquisition of property, plant and equipment (15 ) (2 ) (2 )
Acquisition of intangible asset - - (97 )
Net cash outflow from investing activities (15 ) (2 ) (99 )
Net increase / (decrease) in cash and cash equivalents (9,612 ) 7,047 48,064
Cash and cash equivalents at beginning of period 48,217 153 153
Cash and cash equivalents at end of period 38,605 7,200 48,217
Consolidated Statement of Changes in Equity -
for the six months ending 30 June 2021 and 30 June 2020
(Unaudited) Share Capital Share Premium Share Based Payment Reserve Warrants CLN Reserve Capital Reduction Reserve Shares to be issued Reserve Translation Reserve Other Reserve Retained Earnings Total Equity
'000 '000 '000 '000 '000 '000 '000 '000 '000 '000 '000
Balance at 1 January 2020 5,838 81,227 6,319 474 - 31,957 10,290 202 (28,286 ) (62,314 ) 45,708
Issue of share capital (Fundraise & ATM) - - - - - - - - - - -
Cost of fundraising - - - - - - - - - - -
Issue of share capital (Warrants) - - - - - - - - - - -
Issue of share capital (Loan conversion) - - - - - - - - - - -
Issue of share capital (Options) - - - - - - - - - - -
Converitble loan note interest - - - - - - - - - - -
Share based payments (options) - - 2,164 - - - - - - - 2,164
Share based payments (warrants) - - - - - - - - - - -
Forfeiture of options - - - - - - - - - - -
Total transactions with owners - - 2,164 - - - - - - - 2,164
Comprehensive income
Loss for the period - - - - - - - - - (12,587 ) (12,587 )
Foreign currency translation - - - - - - - - - - -
Loss on disposal of asset - - - - - - - - - - -
OCI-FX - - - - - - - 6 - - 6
Total comprehensive income - - - - - - - 6 - (12,587 ) (12,581 )
Balance at 30 June 2021 5,838 81,227 8,484 474 - 31,957 10,290 208 (28,286 ) (74,901 ) 35,291
Consolidated Statement of Changes in Equity -
for the six months ending 30 June 2021 and 30 June 2020
(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 )
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
Consolidated Statement of Changes in Equity -
ending 31 Decmber 2020
Share Capital Share Premium Capital Reduction Reserve Share Based Payment Reserve (options) Share Based Payment Reserve (warrants) Convertible Loan Note Reserve Other Reserve Shares to be issued Reserve Translation Reserve Retained Earnings Total Equity
'000 '000 '000 '000 '000 '000 '000 '000 '000 '000 '000
Balance as at 1 January 2020 4,099 25,194 31,183 3,850 1,812 1,099 (28,286 ) - 15 (43,146 ) (4,180 )
Issue of share capital (Fundraise & ATM) 1,319 56,964 - - - - - - - - 58,283
Issue of share capital (Warrants) 191 2,491 - - - - - - - - 2,682
Issue of share capital (in lieu of fees) 9 351 - - - - - - - - 360
Issue of share capital (exercise of options) 88 640 - - - - - - - - 728
Issue of share capital (Loan conversion) 132 1,716 - - - (1,848 ) - - - - -
Cost of fundraise - (3,136 ) - - - - - - - - (3,136 )
Convertible loan notes issued - - - - - 120 - - - - 120
Convertible loan note interest - - - - - 216 - - - - 216
Share based payments charge (warrants) - - - 259 (240 ) - - - - 19
Share based payment charge (options) - - - 3,740 - - - - - - 3,740
Options forfeited/cancelled in the year - - (26 ) - - - - - - (26 )
Exercise of options - 64 (1,245 ) - - - - - 1,181 -
Exercise of warrants - 943 (1,596 ) 653 - - - - -
Shares issued in lieu of cash for realisation bonus - - - - - - - 10,290 - - 10,290
Reduction in share capital - (4,000 ) 4,000 - - - - - - - -
Capital distribution - (3,225 ) - - - - - - - (3,225 )
Total 1,739 56,033 775 2,469 (1,337 ) (1,099 ) - 10,290 - 1,181 70,051
Comprehensive loss (Items that will be reclassified to the Statement of Income in future periods)
Exchange differences on translating foreign operations - - - - - - - - 186 - 186
Net loss for the year - - - - - - - - - (20,348 ) (20,348 )
Total Comprehensive loss for the year - - - - - - - 186 (20,348 ) (20,162 )
Balance as at 31 December 2020 5,838 81,227 31,958 6,319 475 - (28,286 ) 10,290 201 (62,313 ) 45,709
to the Interim Financial Statements
for the six month period to 30 June 2021
Life Sciences PLC is a public limited company incorporated in the United Kingdom under the Companies Act and quoted on the main market
of the London Stock Exchange (LSE: 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
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.
principal accounting policies applied in the preparation of these consolidated interim financial statements are set out below. These
policies have been applied consistently to all the years presented unless otherwise stated.
interim consolidated financial statements of the Group and Company have been prepared in accordance with international accounting standards
in conformity with the requirements of the Companies Act 2006. These accounts have been prepared under the historical cost convention.
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.
Group incurred losses during the year and has net assets at the year end.
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.
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.
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.
and Revised Standards
Standards in effect in 2021
in issue but not applied in the current financial statements
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.
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.
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.
to the Interim Financial Statements
for the six month period to 30 June 2021
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.
transactions, balances and unrealised gains on transactions between group companies are eliminated upon consolidation. Unrealised losses
Last updated: Feb 22, 2022