29 Sep 2017 07:00
Tiziana Life Sciences plc
("Tiziana" or "the Company")
Interim Results for the Six Months Ended 30 June 2017
Advancing pipeline of next generation therapeutics and diagnostics for oncology and immune diseases of high unmet need
London, 29 September 2017 - Tiziana Life Sciences plc ("Tiziana", AIM: TILS), the research and clinical stage biotechnology company focussing on proprietary drug candidates to treat cancer and autoimmune diseases, today announces its interim results for the six months ended 30 June 2017.
Highlights during the period:
LEADERSHIP
· The Company significantly enhanced its commercial and clinical development strength with the addition of highly experienced executives to its senior leadership team and Scientific Advisory Board
- Dr. Kunwar Shailubhai joined as Chief Executive Officer and Chief Scientific Officer.
- Dr Arun Sanyal joined as a member of the Scientific Advisory Board.
RESEARCH & DEVELOPMENT
· Milciclib
- Approval in Israel of a phase II clinical trial protocol for testing milciclib in patients with refractory hepatocellular carcinoma (HCC) who fail to respond, or are intolerant to, existing standard of care treatment.
- A similar clinical trial protocol submitted for approval in Italy, Turkey and Greece.
· Anti IL-6R mAb (TZLS-501, formerly NI-1201)
- Acquired exclusive world-wide license for NI-1201, a fully human anti-interleukin-6 receptor (IL-6R) monoclonal antibody from Novimmune SA.
- NI-1201's unique mechanism has the potential to increase anti-inflammatory activity as well as complementing the Company's foralumab programme.
FINANCIAL
· £0.57m (gross) raised through conversion of warrants in March 2017.
· For the six months to 30 June 2017 the consolidated Group made a loss of £3.87m (six months to 30 June 2016: £2.11m).
· The Group ended the period with £2m cash as at 30 June 2017 (31 Dec 2016: £4.7m).
POST PERIOD
· Foralumab
- Publication of a research article in the prestigious journal Clinical Immunology demonstrating the potential of oral therapy with foralumab for inflammatory diseases such as non-alcoholic steatohepatitis (NASH).
- Preparation underway for first study to determine the safety and efficacy of oral foralumab in patients with NASH and type 2 diabetes.
· Milciclib
- Enrolment of the first patient in its phase IIa clinical trial with milciclib in patients with refractory HCC.
- Top line data from this trial, being conducted in Italy, Israel, Greece and Turkey is expected in Q4 2018.
· The holders of the Company's Convertible Loan Note and the Company's Warrant Holders passed the resolutions to convert all of the loan notes and vary the terms of the warrants substantially prior to the intended deadline for consent. The full £12,969,219 (at par value) of the CLNs have been converted into ordinary shares resulting in the issue of 27,645,013 new ordinary shares in the Company.
Gabriele Cerrone, chairman and founder, commented: "We are pleased to report another busy six months for the Company. We have strengthened our senior leadership team and Scientific Advisory Board, and continued to progress our pipeline of drugs to treat rare cancers and difficult to treat autoimmune inflammatory diseases. Our clinical programmes for foralumab and milciclib are progressing well and we were pleased to acquire an exclusive world-wide license for NI-1201, a fully human anti-interleukin-6 receptor monoclonal antibody from Novimmune SA. We are confident of being well positioned to progress these programmes to their next respective value inflection points and we look forward to keeping the market informed of our progress."
Contacts:
Tiziana Life Sciences plc Gabriele Cerrone, Chairman and founder
| +44 (0)20 7493 2853 |
Cairn Financial Advisers LLP (Nominated adviser) Liam Murray / Jo Turner
| +44 (0)20 7213 0880 |
Beaufort Securities Limited (Broker) Zoe Alexander
| +44 (0)20 7382 8300 |
FTI Consulting Simon Conway / Natalie Garland-Collins | +44 (0)20 3727 1000 |
About Tiziana Life Sciences
Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules that treat human disease in oncology and immunology. The Company is focused on its lead compound, milciclib, a molecule which blocks the action of specific enzymes called cyclin-dependent kinases (CDK) involved in cell division as well as a number of other protein kinases. Milciclib is currently completing phase II clinical trials for epithelial thymic carcinoma and/or thymoma in patients previously treated with chemotherapy and has filed an IND to enroll patients in an exploratory trial in Hepatic Cellular Carcinoma (HCC). The Company is also in clinical development of foralumab. Foralumab is the only fully human engineered anti-human CD3 antibody in clinical development. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.
For more information go to http://www.tizianalifesciences.com
EXECUTIVE CHAIRMAN'S STATEMENT
I am pleased to report on the Group's financial results for the six months ended 30 June 2017.
Background
Tiziana Life Sciences plc is a UK AIM-listed biotechnology company (AIM:TILS) focused on developing next generation therapeutics and diagnostics for cancers and immune diseases. Our mission is to discover and develop novel molecules that impact serious human diseases in the area of oncology and immunology. The Company has expanded its pipeline of assets to include lead clinical stage development therapeutic candidates in both oncology and immunology and a drug discovery pipeline of small molecule New Chemical Entities.
The business employs a lean and virtual R&D business model using highly experienced teams of experts for each business function to maximize value accretion and focus capital on the drug development and discovery processes.
In January 2017 the Company established its own R&D facilities at Doylestown Pennsylvania, employing resources with long standing and high qualified experience in the industry.
Clinical programmes
Foralumab
TZLS-401
Foralumab is the only fully human monoclonal anti-CD3 monoclonal antibody (mAb) in clinical development in contrast to the previous non-human or humanized anti-CD3 mAbs. Recent data from studies conducted in the laboratories of Prof. Howard Weiner (Harvard University) and Prof. Kevan Herold (Yale University) suggest that oral administration of foralumab has the potential to improve efficacy while minimizing toxicity in the treatment of inflammatory diseases such as NASH (non-alcoholic steatohepatitis), PBS (primary biliary cholangitis) and other autoimmune and inflammatory diseases.
Results from a previous phase I evaluation of foralumab administered via intravenous injection in patients with Crohn's disease demonstrated foralumab's immunomodulatory activity in humans. Recent clinical studies conducted by Prof. Yaron Ilan with oral administration of anti-CD3 (OKT3; murine mAb) in hepatitis C virus infected patients and in NASH patients suggested that the treatment was well-tolerated and produced immunologic effects consistent with potential clinical benefits.
Our strategy is to build on these exciting findings to develop foralumab for treatment of NASH, PBC and other liver diseases. Foralumab may also be combined TZLS-501, a fully human anti-IL-6R mAb, for treatment of rheumatoid arthritis and other diseases.
Milciclib
TZLS-201
The Company's lead compound, acquired from Nerviano Medical Sciences, is an orally bioavailable, small molecule pan-inhibitor of cyclin-dependent kinases (CDK: 1, 2, 4, 5, and 7) as well as Src family kinases.
The compound was well tolerated by patients with thymoma in phase I and phase II clinical trials. Interim data analysis from the phase II trial indicated that the treatment was well-tolerated and it produced encouraging clinical responses. In another study, milciclib in combination with gemcitabine was found to be well tolerated, and the treatment improved clinical outcomes in patients with refractory solid tumours.
A unique feature of milciclib is its ability to reduce microRNAs miR-221 and miR-222. These microRNAs are consistently upregulated in hepatocellular carcinoma (HCC) patients and might contribute towards resistance to treatment with sorafenib. Thus, we believe milciclib has potential to be developed as a drug candidate for treatment of HCC either as a monotherapy or in combination with sorafenib.
Our strategy is to first initiate clinical studies as a phase IIa monotherapy with milciclib, which will be followed immediately by a phase IIb clinical study in combination with sorafenib.
Pre-clinical programmes
Anti IL-6R mAb
TZLS-501, formerly NI-1201
Recently acquired anti IL-6R mAb is a fully human monoclonal antibody targeting the interleukin-6 receptor (IL-6R). Anti IL-6R mAb offers a unique mechanism of action in which, it binds to both the membrane-bound and soluble forms of the IL-6R and depletes circulating levels of the IL-6 in the blood. An excessive production of IL-6 is regarded as a key driver of chronic inflammation, associated with autoimmune diseases such as multiple myeloma and rheumatoid arthritis.
StemPrintER™
StemPrintER™ is a multi-gene signature assay intended for use in patients diagnosed with estrogen-receptor positive ER+/HER2 negative breast cancers. This in-vitro prognostic test will be used in conjunction with clinical evaluation to identify those patients at increased risk for early and/or late metastasis.
Our diagnostic has a unique biological basis, being based on the detection of cancer stem cell markers, uses a reliable platform (qRT-PCR, FFPE), and has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2400 patients with breast cancer. The development team is preparing for a retrospective validation study using an independent cohort and has discussed submission plans with the FDA.
Financial summary
The Group has made a loss for the six months to 30 June 2017 of £3.87m (six months to 30 June 2016: £2.11m). The loss is detailed in the consolidated statement of comprehensive income.
The Group ended the period with £2m cash as at 30 June 2017 (31 Dec 2016: £4.7m).
Fund raising
In March 2017, warrant holders exercised warrants over 1,789,524 ordinary shares in the Company providing gross proceeds of £572,648.
Funds raised by Tiziana will be used to fund the development of the Group's clinical stage assets milciclib and foralumab, to meet the Group's ongoing liabilities in respect of license agreements, and for general working capital purposes.
Research & development update
In January 2017, Tiziana finalised the acquisition of an exclusive world-wide license for NI-1201, a fully human anti-interleukin-6 receptor (IL-6R) monoclonal antibody (mAb), from Novimmune SA. In exchange for the exclusive license from Novimmune the Company agreed to an upfront cash payment, milestone payments, and a royalty on future sales.
Monoclonal antibodies against IL-6R have been explored as potential drugs to treat inflammation in the past. NI-1201's unique mechanism, however, has the potential to considerably increase anti-inflammatory activity as well as complementing the Company's programme on foralumab (NI-0401), a fully human oral anti-CD3 mAb.
The acquisition of NI-1201 strengthens the Company's business strategy of developing novel fully human mAbs to treat life-threatening inflammatory diseases such as NASH and rheumatoid arthritis. In addition, it represents an opportunity to expand the current research with foralumab, the oral anti-CD3 mAb, to treat autoimmune and inflammatory diseases.
In April, 2017, the Company announced the approval in Israel of a phase II clinical trial protocol for testing milciclib, a novel inhibitor of cell cycle dependent kinases (CDKs), in patients with HCC. A similar clinical trial protocol has been submitted for approval in Italy, Turkey and Greece. The primary objective of these multi-centered, multi-country and dose-ranging phase IIa clinical studies is to evaluate the safety of milciclib in HCC patients who fail to respond or are intolerant to the existing standard of care treatment. In July 2017, it followed announcement of the enrolment of the first patient. Top line data from this trial is expected by Q4 2018. The primary objective of this multi-centre, multi-country and dose-ranging phase IIa clinical study is to evaluate the safety of milciclib in HCC patients who fail to respond to or are intolerant to the existing standard of care treatment.
In June 2017, the Company resolved to discontinue funding of its pre-clinical programme Bcl-3 inhibitors as potential cancer therapeutics, which includes the potential candidate CB1 (TZLS-101), to refocus efforts on other promising candidates in the Company's pipeline, which Tiziana believes have greater near-term potential to deliver value for shareholders. The Company retains all of the intellectual property relating to the Bcl-3 programme and will work with scientists at Cardiff University in examining the potential to develop the programme further with grant funding.
In July 2017, the Company announces publication of a research article in a prestigious journal, Clinical Immunology, entitled: "Oral treatment with foralumab, a fully human anti-CD3 monoclonal antibody, prevents skin xenograft rejection in humanized mice". This is the first-ever published report demonstrating the potential of oral therapy with foralumab for inflammatory diseases such as NASH. Tiziana's foralumab is the only fully human engineered anti-CD3 mAb in clinical development to date.
The Company is currently preparing clinical trials to show the efficacy of oral foralumab in patients, and the first study will determine the safety and efficacy of foralumab in patients with NASH and type 2 diabetes. Foralumab could potentially be an ideal option for patients with NASH in all stages of disease progression, as it targets a pathogenic mechanism which is common to all disease stages.
Appointments
On 14 March 2017, the Company announced the appointment of Dr. Arun Sanyal as a new member of its Scientific Advisory Board.
Dr. Arun Sanyal
Arun Sanyal, MD is the Professor of Medicine, Physiology and Molecular Pathology, Division of Gastroenterology, Hepatology and Nutrition at the Virginia Commonwealth University (VCU) School of Medicine. Dr. Sanyal is special Council Board Member of NIAAA (National Institute on Alcohol Abuse and Alcoholism) and has been a past President of the AASLD (American Association for the Study of Liver Diseases). He has chaired committees at the NIDDK NASH clinical research network and the NIH hepatobiliary study section. Dr. Sanyal was instrumental in establishing the international Liver Forum for NASH and continues to serve as a Chair of this organization comprising industry, academia and regulatory bodies from the USA and EU. Dr. Sanyal is also leading several major drug trials for the treatment of NASH. He has published over 300 papers in leading medical journals and periodicals throughout his career.
On 12 June 2017, the Company announced the appointment of Dr Kunwar Shailubhai (Shailu) as Chief Executive Officer and Chief Scientific Officer. Shailu was previously a Non-Executive Director at the Company.
Dr. Kunwar Shailubhai (Shailu)
Shailu has extensive experience within the sector, drawing on 30 years of experience in research and development of drug candidates for treatment of gastrointestinal disorders, inflammatory diseases and cancers. His appointment follows many years working at Synergy Pharmaceuticals Inc (SGYP: NASDAQ), which he co-founded and where he served as chief scientific officer since 2008.
His pioneering research programme culminated in the development of the drug Trulance™ (plecanatide) which received FDA approval in January, 2017 for the treatment of adults with chronic idiopathic constipation. A supplemental new drug application has been submitted for FDA review of Trulance for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). Prior to joining Tiziana Life Sciences and Synergy Life Sciences, he worked at Callisto Pharmaceuticals, Monsanto Company and as a senior staff fellow at the National Institutes of Health (NIH).
Outlook
It has been a busy six months for the Company as we have bolstered our senior leadership team and Scientific Advisory Board, and continued to progress our pipeline of drugs to treat rare cancers and difficult to treat autoimmune inflammatory diseases.
We have outlined our clinical development plan for foralumab with initial plans to evaluate foralumab in two clinical indications: graft vs host disease and NASH.
Looking forward, we are confident of being well positioned to progress these programmes to their next respective value inflection points.
Gabriele Cerrone
Executive Chairma
Consolidated Statement of Comprehensive Income for the six months ended 30 June 2017
| |||||
6 months to 30 June | 6 months to 30 June | 12 months to 31 Dec | |||
2017 | 2016 | 2016 | |||
£'000 | £'000 | £'000 | |||
Notes | (unaudited) | (unaudited) | |||
Research and development | (2,380) | (727) | (2,956) | ||
Operating expenses | (1,489) | (1,387) | (4,332) | ||
Operating loss | (3,869) | (2,114) | (7,288) | ||
Financial income | -- | 12 | -- | ||
Financial expense | (4) | (4) | (9) | ||
Operating loss before taxation | 2 | (3,873) | (2,106) | (7,297) | |
Tax expense | -- | -- | 89 | ||
Operating loss after taxation | (3,873) | (2,106) | (7,208) | ||
Net loss for the period attributable to equity owners | (3,873) | (2,106) | (7,208) | ||
Other comprehensive income for the period | -- | -- | -- | ||
Total comprehensive loss attributable to equity owners | (3,873) | (2,106) | (7,208) | ||
Basic and diluted loss per share (pence) | |||||
Basic and diluted loss per share on continuing operations | 3 | (4.1p) | (2.3p) | (7.7p) | |
Total basic and diluted loss per share | (4.1p) | (2.3p) | (7.7p) | ||
Consolidated Statement of Financial Position as at 31 December 2017
| ||||||
30 June | 30 June | 31 Dec | ||||
2017 | 2016 | 2016 | ||||
£'000 | £'000 | £'000 | ||||
(unaudited) | (unaudited) | |||||
Assets | ||||||
Non-Current assets: Property, plant and equipment Total Non-current assets
|
21 21 |
-- -- |
28 28
| |||
Current assets: | ||||||
Trade and other receivables | 112 | 99 | 103 | |||
Other current assets Cash and cash equivalents | 217 2,008 | -- 8,281 | 217 4,703 | |||
Total current assets | 2,337 | 8,380 | 5,023 | |||
Total assets | 2,358 | 8,380 | 5,051 | |||
Equity and liabilities | ||||||
|
2,885 2,589 1,943 221 13,858 -- (28,286) 6,849
|
9,435 21,025 1,054 150 13,121 5,625 (28,286) (14,653) |
2,832 2,071 1,935 191 13,535 -- (28,286) (11,036)
| |||
Equity attributed to the owners of the Company | 61 | 7,471 | 3,314 | |||
Current liabilities: | ||||||
Trade and other payables | 2,297 | 909 | 1,737 | |||
2,297 | 909 | 1,737 | ||||
Total Equity and Liabilities | 2,358 | 8,380 | 5,051 | |||
Consolidated Statement of Cash Flows for the year ended 31 December 2016
| |||
6 months to 30 June | 6 months to 30 June | 12 months to 31 Dec | |
2017 | 2016 | 2016 | |
£'000 | £'000 | £'000 | |
(unaudited) | (unaudited) | ||
Cash flows from operating activities | |||
Total comprehensive loss for the period before tax | (3,873) | (2,106) | (7,208) |
Convertible loan interest accrued | -- | -- | 9 |
Convertible loan interest paid as equity | 4 | 4 | -- |
Share based payment - options | 8 | 46 | 927 |
Share based payment - warrants Other share based payments | 30 -- | -- -- | 89 -- |
Net (increase) / decrease in operating assets -Trade / other receivables |
(10) |
248 |
-- |
Net increase / (decrease) in operating liabilities -Trade / other liabilities Depreciation Loss on foreign exchange Lease adjustment |
558 5 5 5 |
163 -- -- -- |
866 8 158 41 |
Net cash used in operating activities
Cash flow from financing activities Proceeds from issuance of ordinary shares Proceeds from issuance of convertible loan notes Fundraising costs Interest on convertible instruments Net cash generated from financing activities
Cash flows from investing activites Acquisition of property, plant and equipment Acquisition of other investments Net cash generated from investing activities
Net increase / (decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period | (3,268)
573 -- -- -- 573
-- -- --
(2,695)
4,703
2,008 | (1,583)
285 676 -- -- 961
-- -- --
(622)
8,903
8,281 | (5,110)
453 709 -- -- 1,162
(35) (217) (252)
(4,200)
8,903
4,703 |
Consolidated Statement of Changes in Equity
for the year ended 31 December 2016
(Unaudited) |
Share Capital
|
Share Premium | Share Based Payment Reserve | Shares to Be Issued Reserve |
Convertible Loan Note Reserve |
Merger Reserve |
Other Reserve |
Retained Earnings |
Total Equity | ||||
£'000 | £'000 | £'000 | £'000 | £'000 | £'000 | £'000 | £'000 | £'000 | |||||
Balance at 1 January 2017 | 2,832 | 2,071 | 1,935 | 191 | 13,535 | - | (28,286) | 11,036 | 3,314 | ||||
Transactions with owners | |||||||||||||
Issue of share capital | 53 | 518 | - | - | - | - | - | - | 571 | ||||
Share based payments (options) | - | - | 8 | - | - | - | - | - | 8 | ||||
Share based payments (warrants) | - | - | - | 30 | - | - | - | - | 30 | ||||
Convertible loan note - equity component | - | - | - | - | 323 | - | - | (314) | 9 | ||||
Total transactions with owners | 53 | 518 | 8 | 30 | 323 | - | - | (314) | 618 | ||||
Comprehensive income | |||||||||||||
Loss for the period | - | - | - | - | - | - | - | (3,873) | (3,873)
| ||||
Total comprehensive income | - | - | - | - | - | - | - | (3,873) | (3,873)
| ||||
Balance at 30 June 2017 | 2,886 | 2,589 | 1,943 | 221 | 13,858 | - | (28,286) | 6,849 | 61 | ||||
Balance at 1 January 2016 | 9,375 | 20,632 | 1,008 | 102 | 12,287 | 5,625 | (28,286) | (12,239) | 8,504 | ||||
Transactions with owners | |||||||||||||
Issue of share capital | 60 | 393 | - | - | - | - | - | - | 453 | ||||
Share based payment (options) Share based payment (warrants) Convertible loan note - equity component | - - - | - - - | 46 - - | - 48 - | - - 834 | - - - | - - - | - - (308) | 46 48 526 | ||||
Associated transaction costs | - | - | - | - | - | - | - | - | - | ||||
Total transactions with owners | 60 | 393 | 46 | 48 | 834 | - | - | (308) | 1,073 | ||||
Comprehensive income | |||||||||||||
Loss for the period | - | - | - | - | - | - | - | (2,106) | (2,106) | ||||
Total comprehensive income | - | - | - | - | - | - | - | (2,106) | (2,106) | ||||
Balance at 30 June 2016 | 9,435 | 20,025 | 1,054 | 150 | 13,121 | 5,625 | (28,286) | (14,653) | 7,471 | ||||
| |||||||||||||
(Unaudited) |
Share Capital
|
Share Premium | Share Based Payment Reserve | Shares to Be Issued Reserve |
Convertible Loan Note Reserve |
Merger Reserve |
Other Reserve |
Retained Earnings |
Total Equity |
| |||
£'000 | £'000 | £'000 | £'000 | £'000 | £'000 | £'000 | £'000 | £'000 |
| ||||
| |||||||||||||
Balance at 1 January 2016 | 9,375 | 20,632 | 1,008 | 102 | 12,287 | 5,625 | (28,286) | (12,239) | 8,504 |
| |||
Transactions with owners |
| ||||||||||||
Issue of share capital Share based payment (options) |
61 - |
393 - |
- 927 |
- - |
- - |
- - |
- - |
- - |
454 927 |
| |||
Share based payment (warrants) Convertible loan note - equity component Cancellation of deferred shares Capital reduction Prior year adjustments
| - -
(6,604) - - | - -
- (18,954) - | - -
- - - | 89 -
- - - | - 1,248
- - - | - -
- (5,625) - | - -
- - - | - (690)
- 31,183 (10)
| 89 558
- - (10)
|
| |||
Total transactions with owners | (6,543)
| (18,561)
| 927 | 89 | 1,248
| (5,625)
| - | 30,483
| 2,018 |
| |||
Comprehensive income |
| ||||||||||||
Loss for the period | - | - | - | - | - | - | - | (7,208) | (7,208) |
| |||
| |||||||||||||
Total comprehensive income | - | - | - | - | - | - | - | (7,208) | (7,208) |
| |||
| |||||||||||||
Balance as at 31 December 2016 | 2,832 | 2,071 | 1,935 | 191 | 13,535 | - | (28,286) | 11,036 | 3,314 |
| |||
| |||||||||||||
| |||||||||||||
Notes to the Interim Financial Statements for the six month period to 30 June 2017
1. GENERAL INFORMATION
Tiziana Life Sciences PLC is a public limited company incorporated in the United Kingdom under the Companies Act and quoted on the AIM market of the London Stock Exchange (AIM: TILS). The address of its registered office is given on page 1. The principal activities of the Company and its subsidiaries (the Group) are that of a clinical stage biotechnology company focussed on targeted drugs to treat diseases in oncology and immunology.
These financial statements are presented in thousands of pounds sterling (£'000) which is the functional currency of the primary economic environment in which the Company operates.
The ultimate parent of the group is Planwise Group Limited, incorporated in the British Virgin Islands. Gabriele Cerrone is the ultimate beneficial owner of the entire issued share capital of Planwise Group Limited.
2. OPERATING LOSS
The Group and Company's operating loss for the year is stated after charging the following:
6 months to 30 June 2017 | 6 months to 30 June | 12 months to 31 Dec 2016 | |
(Unaudited) | (Unaudited) | ||
£'000 | £'000 | £'000 | |
Depreciation | 5 | -- | 8 |
Foreign exchange losses/(Gain) | 5 | 25 | 159 |
10 | 25 | 167 | |
3. Earnings per share
Basic earnings per share is calculated by dividing the loss attributable to equity holders of the Group by the weighted average number of ordinary shares in issue during the year.
6 months to 30 June | 6 months to 30 June | 12 months to 31 Dec | |
2017 | 2016 | 2016 | |
(unaudited) | (unaudited) | ||
Total comprehensive loss for the period (£'000) | (3,873 | (2,106) | (7,208) |
Basic and diluted weighted average number of shares | 95,305,823 | 92,782,184 | 93,592,195 |
Basic and diluted loss per share - pence | (4.1) | (2.3) | (7.7) |
As the Group is reporting a loss from continuing operations for the period then, in accordance with IAS 33, the share options are not considered dilutive because the exercise of the share options would have an anti-dilutive effect. The basic and diluted earnings per share as presented on the face of the Statement of comprehensive income are therefore identical. All earnings per share figures presented above arise from continuing and total operations and therefore no earnings per share for discontinued operations are presented.
Post balance sheet events
On 12 July 2017, the Company announced a proposed restructuring of convertible loan notes ("CLN") and a proposed variation to the terms of warrants issued. The Company proposed that CLN Holders be offered an additional bonus coupon of 3 years of interest at the relevant applicable rate of return for agreeing to the immediate conversion of the CLN's into ordinary shares. If the CLN Holders agree to the proposal they will be subject to a restriction not to dispose of the relevant shares for a period of 12 months following conversion.
Furthermore, the Company has proposed to vary the terms of the warrants associated with the CLNs by extending the exercise period of these warrants to 31 December 2021. If the Warrant Holders agreement to the proposal, the ordinary shares they receive upon conversion of the warrants would also be subject to a restriction not to dispose of the relevant shares for a period of 12 months following such conversion.
On 16 August 2017, the Company announces that further to the proposals announced on 12 July 2017, the holders of the Company's Convertible Loan Note ("CLN Holders") and the Company's Warrant Holders ("Warrant Holders") have passed the resolutions that were put to them to convert all of the loan notes and vary the terms of the warrants substantially prior to the intended deadline for consent. Accordingly the full £12,969,219 (at par value) of the CLNs have now been converted into ordinary shares (including accrued interest), resulting in the issue of 27,645,013 new ordinary shares in the Company. Therefore the fully diluted issued share capital of the Company is 138,216,920 ordinary shares (assuming all options and warrants, vested and unvested, exercised and exercisable, were converted).
On 19 July 2017, the Company announced the enrolment of its first patient into the phase IIa clinical trial with milciclib.
In July 2017, the Company announces publication of a research article in a prestigious journal, Clinical Immunology, entitled: "Oral treatment with foralumab, a fully human anti-CD3 monoclonal antibody, prevents skin xenograft rejection in humanized mice". This is the first-ever published report demonstrating the potential of oral therapy with foralumab (NI-0401) for inflammatory diseases such as non-alcoholic steatohepatitis (NASH). Tiziana's foralumab is the only fully human engineered anti-CD3 monoclonal antibody (mAb) in clinical development to date.
On 11 August 2017, the Company entered into a separation agreement with James Tripp, the former COO. James's employment with the Company was terminated on 16 May 2017. The Company has committed to paying a severance payment which is equivalent to nine months of his base compensation which was in effect as of the Separation Date. This amounts to approximately £141,000.