TIDMTILS

RNS Number : 9690M

Tiziana Life Sciences PLC

24 September 2021

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 unmet need

London, 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.

Highlights during the period:

CLINICAL PROGRAMMES

Foralumab

TZLS-401

-- Announced an update on further analysis of lymphocyte subsets from blood samples from a Phase 1 study with nasally administered Foralumab in healthy volunteers. Results exhibiting statistically significant immunomodulatory effects on CD8 cytotoxic T-lymphocytes and other inflammatory biomarkers were observed. Systemic levels of Foralumab were below the lower quantitation limit of 8 ng/mL suggesting that nasally administered Foralumab appears to exert its effects via nasal epithelium utilizing local and lymphatic immune systems directly . These data support other clinical and pre-clinical studies showing that this route of administration is capable of inducing site-targeted immunomodulation and anti-inflammatory effects. Furthermore these pharmacodynamic data point to a clinical dose range that Tiziana intends to test in further clinical development among MS patients.

-- Announced positive data from the exploratory clinical study in Brazil investigating nasally administered Foralumab, its proprietary anti-CD3 human monoclonal antibody, either alone or in combination with orally administered dexamethasone ("Dexa") in COVID-19 patients. The clinical study was completed in collaboration with scientific teams at the Harvard Medical School (Boston, USA), and INTRIALS, a full-service Latin American CRO based in São Paulo, Brazil . T he objectives of the trial were to assess safety of the treatment and to evaluate if progression of the diseases is delayed with nasally administered 100mcg/day Foralumab (50mcg/nostril). This study enrolled 39 patients randomized in three cohorts: cohort 1, control with no treatment (n=16); cohort 2; nasally administered Foralumab plus 3 days of priming with orally administered 6 mg Dexamethasone (n=11) and cohort 3; nasally administered Foralumab (n=12). The Foralumab treatment regimen was once a day dosing for 10 consecutive days There were no significant differences between cohort 2 and 3. All treatments were well-tolerated. There were no grade 3 or 4 severe adverse events ("SAEs") in any of the cohorts. The CT scans of the lungs showed the improvement was approximately double that shown in patients treated with Foralumab as compared to those in the control group. The results of the study were published in the peer-reviewed journal, Frontiers in Immunology entitled "Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung In ammation and Blood In ammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study" in August 2021.

-- Signed an agreement with FHI CRO to conduct a follow-up, "proof of concept" Phase 2 study in hospitalized patients with severe COVID-19 and lung inflammation that is planned to begin in Q4 2021. Foralumab will be delivered intranasally using a metered dose delivery device.

-- Announced that the first patient with secondary progressive multiple sclerosis (SPMS) was dosed with nasally administered Foralumab at the Brigham and Women's Hospital (BWH), Harvard Medical School, Boston, MA. Nasal Foralumab 50 mcg (25 mcg/nostril) was administered in 3-week cycles, with 3 times/week dosing for the first 2 weeks followed by 1 week of rest period. This first-ever clinical study in SPMS patients, under an Individual Patient Expanded Access IND, will continue for six months to evaluate routine safety, tolerability, and neurological behaviors. The study will also examine microglial activation, by positron emission tomography ( PET), immunological and neurodegenerative markers to assess clinical responses following the treatment regimen.

Anti IL-6R mAb

TZLS-501, formerly NI-1201

-- Working with Sciarra Laboratories to evaluate two hand-held nebulizer devices for use in the study and characterizing physical/performance characteristics. Once a device has been selected, a few candidate formulations of anti-IL6R mAb, from formulation development studies at STC Biologics, will be manufactured at small scale and evaluated using the devices.

-- Engaged ITR Laboratories in Canada to complete inhalation safety toxicology studies in Cynomolgous monkeys using the purified, characterized anti-IL6R mAb test item. Results from the study will be used to establish dosing fora Phase 1 study in healthy volunteers. Additional parenteral administration safety toxicology studies are in progress at ITR Laboratories to support clinical studies for treatment of autoimmune and inflammatory diseases.

Milciclib

TZLS-201

-- A nnounced that it had executed an agreement with Takanawa Japan K.K, Pharma Team, (Takanawa) for a strategic business development plan to Identify a clinical partner in Japan and other Asian countries for further clinical development of Milciclib for treatment in advanced hepatocellular carcinoma (HCC) patients. HCC is the most common type of liver cancer and affects approximately 200,000 people per year.

Intellectual Property

-- As of September 2021, the Company has a total of 306 granted patents, 281 foreign and 25 US patents.

New appointments

-- Appointed Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer, Dr Thoma Adams Ph.D. as Head of Drug Development and an executive director and r. Kevin Schutz, PharmD, as Vice-President of Regulatory Affairs.

Highlights post period end:

-- On September 2, 2021, Tiziana and Precision Biosciences announced an exclusive license agreement to explore Tiziana's foralumab as an agent to induce tolerance of allogeneic CAR T cells to potentially improve the clinical outcome of CAR T cell therapy. Precision's approach to manufacturing produces CAR T cells that are virtually CD3-negative. Foralumab will be used as a lymphodepletion or tolerizing agent, either alone or in combination with other co-stimulatory molecules, to improve the long-term survival of CAR T cells in cancer treatment.

-- Tiziana has formally commenced its strategic plan to change its corporate structure by establishing Tiziana Life Sciences Ltd, a Bermuda-incorporated company, as the ultimate parent company of the of the Tiziana Group. The reorganisation will be achieved by a scheme of arrangement under Part 26 of the Companies Act 2006.

FIINANCIAL

-- For the six months to 30 June 2020 the consolidated Group made a loss of GBP12.59m (six months to 30 June 2020: GBP3.9m).

-- The Group ended the period with GBP38.6m cash as at 30 June 2021 (31 December 2020: GBP48.2m).

-- Research and development (R&D) expenses increased to GBP12.6m compared to GBP3.9m in the first half of 2020. The increase is primarily expenses related to the advancement of our proprietary programs, TZLS-401 and TZLS-501.

-- The Company cancelled the admission of its Ordinary Shares to trading on AIM and admitted its shares to trading on the main market for listed securities (of London Stock Exchange plc in Jnaiary 2021.

The 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 addtional equity capital.

Contacts:

 
Tiziana Life Sciences plc 
 Gabriele Cerrone, Chairman and founder   +44 (0)20 7495 2379 
 
 
 

About Tiziana Life Sciences

Tiziana 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.

EXECUTIVE CHAIRMAN'S STATEMENT

I 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.

We 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.

Based 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.

Upon 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.

We 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.

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 2021

 
                                                    6 months          6 months        12 months 
                                                    to 30           to 30 June         To 31 Dec 
                                                     June 
                                                        2021              2020              2020 
                                                     GBP'000           GBP'000           GBP'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

as at 30 June 2021

 
 
                                         30 June       30 June    31 Dec 
                                            2021          2020       2020 
                                         GBP'000       GBP'000    GBP'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

for the 6 months ended 30 June 2021

 
 
                                              6 months   6months to     12 months 
                                                    to                         to 
                                               30 June      30 June   31 December 
                                                  2021         2020          2020 
                                               GBP'000      GBP'000       GBP'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                        -        (190)             - 
  conversion) 
 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                       54            -             - 
  use asset 
 
 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

 
                                             Share    Warrants    CLN Reserve      Capital    Shares 
                                             Based                                Reduction    to be     Translation 
                        Share      Share    Payment                                Reserve    issued       Reserve       Other     Retained     Total 
     (Unaudited)       Capital    Premium   Reserve                                           Reserve                   Reserve    Earnings     Equity 
                      GBP'000    GBP'000    GBP'000   GBP'000       GBP'000        GBP'000    GBP'000     GBP'000      GBP'000     GBP'000    GBP'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

 
                                                        Share                Warrants             CLN Reserve 
                                                        Based                                                           Capital       Translation 
                     Share      Share                 Payment                                                         Reduction           Reserve                      Other          Retained                    Total 
   (Unaudited)     Capital    Premium                 Reserve                                                           Reserve                                      Reserve          Earnings                   Equity 
                   GBP'000    GBP'000          GBP'000                      GBP'000            GBP'000                  GBP'000           GBP'000                    GBP'000           GBP'000                  GBP'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 -

for the year ending 31 Decmber 2020

 
                           Share     Share     Capital      Share       Share      Convertible    Other     Shares    Translation   Retained    Total 
                          Capital   Premium   Reduction     Based       Based       Loan Note     Reserve    to be      Reserve     Earnings    Equity 
                                               Reserve     Payment     Payment       Reserve                issued 
                                                           Reserve     Reserve                              Reserve 
                                                          (options)   (warrants) 
                          GBP'000   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 
  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 
                         --------  --------  ----------  ----------  -----------  ------------  ---------  --------  ------------  ---------  --------- 
 

Notes to the Interim Financial Statements

for the six month period to 30 June 2021

   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 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 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.

   2.     ACCOUNTING POLICIES 

The 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.

Basis of preparation

These 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.

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 assets 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 2021

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.

Several 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 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 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 are issued by the Group in return for services and as part of a financing transaction. Warrants issued in return for services. Warrants issued in return for services fall within scope of IFRS 2. The financial liability component is measured at fair value and charged to the Consolidated Statement of Income. There is no remeasurement of fair value. Warrants issued as part of a financing transaction. Warrants issued as part of a financing transaction fall outside the scope of IFRS 2. These are classified as equity instruments because a fixed amount of cash is exchanged for a fixed amount of equity. The fair value is recognised within equity and 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

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.

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-ofuse assets in a consistent manner to its property, plant and equipment (see Note 13).

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.

Measurement and recognition of leases as a lessee

At lease commencement date, the Group recognises a right-of-use asset and a lease liability in its consolidated statement of financial position. The right-of-use asset is measured at cost, which is made up of the initial measurement of the lease liability, any initial direct costs incurred by the Group, an estimate of any costs to dismantle and remove the asset at the end of the lease, and any lease payments made in advance of the lease commencement date (net of any incentives received).

The Group depreciates the right-of-use asset on a straight-line basis from the lease commencement date to the earlier of the end of the useful life of the right-of-use asset or the end of the lease term. The Group also assesses the right-of-use asset for impairment when such indicators exist.

At the commencement date, the Group measures the lease liability at the present value of the lease payments unpaid at that date, discounted using the Group's incremental borrowing rate because as the lease contracts are negotiated with third parties it is not possible to determine the interest rate that is implicit in the lease. The incremental borrowing rate is the estimated rate that the Group would have to pay to borrow the same amount over a similar term, and with similar security to obtain an asset of equivalent value. This rate is adjusted should the lessee entity have a different risk profile to that of the Group.

Lease payments included in the measurement of the lease liability are made up of fixed payments (including in substance fixed), variable payments based on an index or rate, amounts expected to be payable under a residual value guarantee and payments arising from options reasonably certain to be exercised.

Subsequent to initial measurement, the liability will be reduced by lease payments that are allocated between repayments of principal and finance costs. The finance cost is the amount that produces a constant periodic rate of interest on the remaining balance of the lease liability.

The Group as a lessor

As a lessor the Group classifies its leases as either operating or finance leases. A lease is classified as a finance lease if it transfers substantially all the risks and rewards incidental to ownership of the underlying asset and classified as an operating lease if it does not.

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 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.

The following are considered to be critical accounting estimates:

Share-based payments

The Group accounts for share-based payment transactions for employees in accordance with IFRS 2 Share-based Payment, which requires the measurement of the cost of employee services received in exchange for the options on our ordinary shares, based on the fair value of the award on the grant date.

The Directors selected the Black-Scholes-Merton option pricing model as the most appropriate method for determining the estimated fair value of our share-based awards without market conditions. For performance-based options that include vesting conditions relating to the market performance of our ordinary shares, a Monte Carlo pricing model was used in order to reflect the valuation impact of price hurdles that have to be met as conditions to vesting.

The resulting cost of an equity incentive award is recognised as expense over the requisite service period of the award, which is usually the vesting period. Compensation expense is recognised over the vesting period using the straight-line method and classified in the consolidated statements of comprehensive income.

The assumptions used for estimating fair value for share-based payment transactions are disclosed in note 27 to our consolidated financial statements.

The following are considered to be critical accounting judgments:

Income taxes

Deferred tax assets are recognised for unused tax losses to the extent that it is probable that taxable profit will be available against which the losses can be utilised. Significant management judgment is required to determine the amount of deferred tax assets that can be recognised based upon the likely timing and the level of future taxable profits together with future tax planning strategies.

Research and development costs

Research and development costs are charged to expense as incurred and are typically made up of clinical and preclinical activities, drug development and manufacturing costs, and third-party service fees, including for clinical research organizations and investigative sites. When entering into agreements with third parties which provide the rights to conduct research into specific biological processes the Group accounts 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.

Leases

IFRS 16 defines the lease term as the non-cancellable period of a lease together with the options to extend or terminate a lease, if the lessee were reasonably certain to exercise that option. This will take into account the length of time remaining before the option is exercisable, current trading, future trading forecasts as to the ongoing profitability of the organisation and the level and type of planned future capital investment. The judgement is reassessed at each reporting period. A reassessment of the remaining life of the lease could result in a recalculation of the lease liability and a material adjustment to the associated balances.

   4.     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 December 
                                             2021          2020            2021 
                                      (Unaudited)   (Unaudited)     (Unaudited) 
                                          GBP'000       GBP'000         GBP'000 
 
 License Fees                                   -             -           (550) 
 Realisation Bonus                              -             -        (10,290) 
 Depreciation of Property, Plant 
  and                                         (2)           (2)             (4) 
 Depreciation (Right-of-use asset)           (54)          (33)            (66) 
 Foreign exchange losses                  (2,709)          (30)           (186) 
                                     ------------  ------------  -------------- 
                                          (2,765)          (65)        (11,096) 
                                     ============  ============  ============== 
 
   5.     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 
                                              2021          2020          2020 
 
                                       (unaudited)   (unaudited) 
                                      ------------  ------------  ------------ 
 
 Total comprehensive loss for 
  the period (GBP'000)                    (12,594)       (3,911)      (20,162) 
 
 Basic and diluted weighted average 
  number of shares                     150,224,119   150,224,119   169,065,390 
 
 Basic and diluted loss per share 
  - pence                                    (7.4)         (2.6)        (12.0) 
 
 

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.

   6.     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 2021                         24              6           30 
 Additions                                  4              11          15 
 Disposals                                  -              -            - 
 
 At 30 June 2021                           28              17          45 
 
 Depreciation 
 At 1 January 2021                        (23)            (6)         (29) 
 Charge in period                           -             (2)          (2) 
 
 At 30 June 2021                          (23)            (8)         (31) 
 
 Net book value as at 30 June 
  2021                                      5              7           14 
                                     ==============  =============  ======== 
 
 Net book value as at 30 June 
  2020                                      2              3            5 
                                     ==============  =============  ======== 
 
 Net book value as at 31 December 
  2020                                      1              -            1 
                                     ==============  =============  ======== 
 
   7.     Share based payments 

Options

The Company 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.

 
                                June 2021                            June 2020 
                    Options ('000)       Weighted        Options ('000)       Weighted 
                                      Average exercise                     Average exercise 
                                       price (pence)                        price (pence) 
 
 Outstanding at 
  1 January                 17,024                  49           16,379                  86 
 Granted                     4,750                 136            2,370                  35 
 Forfeited                                                         (50)               (160) 
 Exercised                                                        (420)                (23) 
 Cancelled                                                            -                   - 
 
 Outstanding at 
  30 June                   21,774                 108           18,279                  59 
                   ===============  ==================  ===============  ================== 
 
 Exercisable at 
  31 December                6,249                  41            5,521                  32 
                   ===============  ==================  ===============  ================== 
 

During the year to 30 June 2021, zero options were exercised. No options were exercised in the year to 31 December 2020.

The total outstanding fair value charge of the share option instruments is deemed to be approximately GBP9,992k (2020: GBP5,161k).

Share options outstanding at the end of June 2021 have the following expiry dates and exercise prices:

 
 Grant Date         Expiry Date        Exercise Price    Share Options 
                                                          as at 30 June 
                                                           2021 ('000) 
 26 June 2014       26 June 2024       GBP0.35               1,831 
 30 April 2018      30 April 2028      GBP0.8175             1,300 
 6 May 2020         5 May 2028         GBP0.35               12,393 
 23 July 2020       26 July 2030       GBP1.575              1,000 
 25 August 2020     24 August 2030     GBP1.475               500 
 2 February 2021    2 February 2025    GBP1.02               1,250 
 2 February 2021    2 February 2025    GBP1.49               3,500 
                                                        --------------- 
 Total                                                       21,774 
 
 
 

Fair value of options granted

The Directors have used the Black-Scholes option pricing model to estimate the fair value of most of the options granted during the year to June 30, 2021 applying the assumptions below.

Historical volatility is based on the historical volatility of the Company itself.

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.

The model inputs for options granted during the year to 30 June 2021 valued under the Black Scholes Valuation model included:

 
                               2 February       2 February 
 Grant date share price              1.59             1.59 
 Exercise share price                1.02             1.49 
 Risk free rate            0.02% to 0.10%   0.02% to 0.10% 
 Expected Volatility         188% to 283%     188% to 283% 
 Option life                      5 years          5 years 
 Weighted average share           GBP0.14          GBP1.02 
  price 
 Weighted average fair            GBP0.56          GBP1.49 
  value share option 
 
 

Warrants

For each set of warrants, the charge has been expensed over the service period. A share-based payment charge for the year of GBPnil (202;0 GBPnil) has been expensed in the statement of comprehensive income.

 
 
                                   6 months to      6 months to     12 months to 
                                  30 June 2021     30 June 2020           31 Dec 
                                   (Unaudited)      (Unaudited)             2020 
 GBP000 
 Outstanding at 1 January                  474            1,812            1,812 
 Granted                                     -                -              259 
 Transfer to share premium 
  on exercise of warrants                    -            (473)          (1,597) 
                               ---------------  ---------------  --------------- 
 Outstanding at 31 Decemeber               474            1.339              474 
                               ---------------  ---------------  --------------- 
 
   8.     Convertible loan notes 

Planwise Convertible Loan Notes 2016

From the date of the reverse acquisition a convertible loan note of GBP200,000 was in existence as detailed in the Admission Document dated 31 March 2014. Proceeds of the subscriptions for the notes are to be used exclusively to finance the Group's ongoing working capital requirements. The terms of the loan note are that the loan notes, plus accrued interest at a rate of 4 per cent above Bank of England base rate per annum, will convert into ordinary shares in the Company at a price of GBP0.10 per share at the election of Planwise any time after the second anniversary of the re-admission to AIM on 24 April 2014.

Accounting for the convertible debt instrument

The net proceeds received from the issue of the Planwise Convertible Loan Note 2016 has been recorded as a debt liability in the Statement of financial position and the accrued interest charged to the Statement of comprehensive income and the debt liability. The liability for the convertible debt instrument at 30 June 2021 is;

 
 
 
 
                                       Planwise       Planwise Convertible 
                                      Convertible          Loan Note 
                                       Loan Note              2020 
                                         2021 
                                       GBP000               GBP000 
                                   --------------  ----------------------- 
 
   Convertible loan notes issued          200                 200 
 Accrued interest                        64                   52 
                                   --------------  ----------------------- 
 
                                         264                 252 
                                   ==============  ======================= 
 
   9.     Trade and other payables 
 
 
                                     (unaudited)    (unaudited) 
                                         30 June        30 June    31 December 
                                            2021           2020           2020 
                                         GBP'000        GBP'000        GBP'000 
                                   -------------  -------------  ------------- 
 
 Convertible loan note liability             264            252            252 
 Fixed Term Unsecured Loan                    95              -             94 
 Trade payables                            2,764          2,598          2,456 
 Other payables                               34              6             11 
 Accruals                                  1,807          1,741          1,628 
                                   -------------  -------------  ------------- 
                                           4,964          4,596          4,441 
                                   =============  =============  ============= 
 

10. Finance income and costs

 
 
                                       (unaudited)             (unaudited) 
                                           30 June                 30 June    31 December 
                                              2021                    2020           2020 
                                           GBP'000                 GBP'000        GBP'000 
                              --------------------  ----------------------  ------------- 
 
 Finance Income 
 Finance income received on 
  net investment in lease                        -                       -              6 
                              --------------------  ----------------------  ------------- 
                                                 -                       - 
 
   Finance Expenses 
 Finance charge accrued on 
  convertible loan notes                        13                       -            236 
 Interest expense on lease 
  liabilities                                    5                      5              13 
                              --------------------  ----------------------  ------------- 
                                                18                      5             249 
                                                18                      5             243 
 
 

11. FINANCE LEASE RECEIVABLES

In Jan 2021, the Group entered into two new leases for lab and office space.

In November 2019, the Group subleased one of its leased office spaces. The sublease has been classified as a finance lease receivable.

 
 
                 (unaudited)    (unaudited) 
                     30 June        30 June    31 December 
                        2021           2020           2020 
                     GBP'000        GBP'000        GBP'000 
               -------------  -------------  ------------- 
 
 Current                 169             --            111 
 Non-current             304            236              - 
               -------------  -------------  ------------- 
                         473            236            111 
               =============  =============  ============= 
 

The undiscounted lease payments to be received over the next 5 years are as follows:

 
                               1 Year   2 years   3 or more 
                                                    years 
                               GBP000   GBP000     GBP000 
 
 Undiscounted lease payments     43        -          - 
  receivable 
 
 
                                 43        -          - 
                              =======  ========  ========== 
 

The undiscounted lease payments do not include a discount factor charge of GBP5k.

During the six months to June 30, 2021, the Group received GBP46k of income from its subleasing activities.

 
 Finance Lease Receivable    30 June 2021   30 June 2020 
                                GBP000        GBP'000 
 
 Finance Lease receivable 
  as at 1 Jan 2020               111            236 
 Sublease income                 (68)           (46) 
                                  43            190 
                            =============  ============= 
 

12. 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 2021, the Group entered into new lease agreements for use of additional lab and office space.

 
 Right-of-use assets            30 June   30 June   31 December 
                                  2021      2020        2020 
                                GBP000    GBP000      GBP000 
 At 1 January                     262       329         329 
 Additions                        200        -           - 
 Depreciation                    (53)      (33)        (67) 
 Foreign exchange movements       (3)       12           - 
                               --------  --------  ------------ 
                                  406       308         262 
                               ========  ========  ============ 
 
 
  Lease Liabilities               30 June   30 June   31 December 
                                     2021      2020        2020 
                                   GBP000    GBP000      GBP000 
   At 1 January                      407       623         623 
   Additions                         200        -           - 
   Interest expense                   5        10          13 
   Lease payments                   (127)     (94)        (235) 
   Foreign excahange movements      (11)        -           6 
                                     472       539         407 
                                  ========  ========  ============ 
 
 

Lease liabilities are presented in the statement of financial; position as follows:

 
                30 June   30 June   31 Dec 
                  2021      2020     2020 
                GBP000    GBP000    GBP000 
 Current          168       231      195 
 Non-current      304       308      212 
 
 
                  472       539      407 
               ========  ========  ======= 
 

The lease liabilities are secured by the related underlying assets. Future minimum lease payments as at 30 June 2021 were as follows:

 
                                    Minimum lease payment due 
                        Within 1   1-2 years   2-5 years   Over 5   Total 
                          year                              years 
 30 June 2021 
 Lease payments           212         122         182        -       516 
 Finance Charges          (44)                               -      (44) 
                       ---------  ----------  ----------  -------  ------ 
 Net Present Values       168         122         182                472 
                       =========  ==========  ==========  =======  ====== 
 

13. Post balance sheet events

On 20 August 2021, the Company announced it has formally commenced its strategic plan to change its corporate structure by establishing Tiziana Life Sciences Ltd , a Bermuda-incorporated company, as the ultimate parent company of the of the Tiziana Group. Holders of ordinary shares in Tiziana Life Sciences PLC ("Old Tiziana") will receive shares in New Tiziana in exchange for their Old Tiziana Shares (and Old Tiziana will become a wholly-owned subsidiary of New Tiziana). It is proposed that the New Tiziana Shares will be directly listed on NASDAQ following the Scheme becoming effective. At the same time the Old Tiziana Shares will be delisted from the standard segment of the official list of the Financial Conduct Authority ("FCA") and from trading on the main market of the London Stock Exchange plc in London and the ADSs (each representing two Old Tiziana Shares) will cease trading on NASDAQ. Holders of Old Tiziana Shares and ADSs will instead receive New Tiziana Shares which will only trade on NASDAQ.

On 2 September 2021, the Company announced an exclusive license agreement to explore Tiziana's foralumab, a fully human anti-CD3 monoclonal antibody (mAb), as an agent to induce tolerance of allogeneic CAR T cells to potentially improve the clinical outcome of CAR T cell therapy.

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IR BLGDCDXDDGBS

(END) Dow Jones Newswires

September 24, 2021 12:49 ET (16:49 GMT)

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