Full Press Release Details
Tiziana Life Sciences Ltd
("Tiziana" or "the Company")
Updated Interim Results for the Six Months Ended
NEW YORK, December 29, 2023 - Tiziana Life Sciences, Ltd. (Nasdaq:
TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies
via novel routes of drug delivery, today announced interim financial results for the six months ended June 30, 2023, and provided a corporate
update on its lead programs in development.
Gabriele Cerrone, Executive Chairman, founder
and interim Chief Executive Officer of Tiziana, commented, "After announcing our focus on the development of intranasal foralumab
in CNS-mediated inflammatory diseases at the end of last year, we began 2023 with a stream of continuous, positive developments in these
programs. Intranasal foralumab's unique action on regulatory T-cells, along with its potential
to treat multiple inflammatory-driven diseases, has been published in major medical journals and recognized in the media on multiple occasions.
In September, we also recently announced intranasal foralumab's progress in Alzheimer's disease with study data published
in the Proceedings of the National Academy of Sciences and clearance to proceed with clinical testing in this indication following
Cerrone continued, "Our near-term strategic focus is to prioritize resources for the clinical development of this unique
therapeutic candidate, beginning with CNS focused indications, to maximize shareholder value, while still maintaining optionality for
our other research programs, including milciclib in oncology. We remain steadfast towards our goal to become a leading company pioneering
intranasal therapies for inflammatory diseases."
First Half 2023 Developments Related to Foralumab
a publication in the preeminent1, peer-reviewed journal, Proceedings of the National Academy of Sciences (PNAS),
that illustrates the immunological basis of the mechanism of action (MoA) for intranasal foralumab. The publication highlights
that the immunological basis of the MoA for intranasal foralumab is based on increasing production of na ve-like T cells and Tregs,
while simultaneously decreasing the production of effector T cells. Further, the publication demonstrates that intranasal foralumab has
similar immune gene expression effects in COVID patients, MS patients and in heathy volunteers. The study concludes that immunomodulation
by nasal anti-CD3 mAb represents a novel avenue for treatment of inflammatory human diseases. The
publication can be found at https://www.pnas.org/doi/10.1073/pnas.2220272120.
2023 First Half of Year Operational Updates
In June, the Company announced
the appointment of its Chief Medical Officer (CMO), Matthew Davis, M.D., R.Ph., to
Chief Operating Officer (COO). In this additional role, Dr. Davis will further drive
the Company's growth and strategic initiatives. As COO, Dr. Davis now reports to Gabriele Cerrone,
Executive Chairman, Founder, and Acting Chief Executive Officer of Tiziana.
In August, the Company announced
the appointment of William A. Clementi, Pharm.D., FCP as Chief Development Officer (CDO), effective September 1, 2023. In this role,
Dr. Clementi is responsible for overseeing the Company's development strategies and advancing its portfolio of therapeutic candidates.
2023 Recent Clinical Program Updates
2023 First Half Financial Results
Tiziana's Interim Report
can be accessed by visiting the Investors section of the Company's website at https://ir.tizianalifesciences.com/financial-information/interim-reports.
Tiziana's Annual Report
on Form 20-F can be accessed by visiting either the SEC's website at www.sec.gov or the Investors section of the Company's
Activated T cells play an important role in the inflammatory process.
Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating
T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients
with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial
began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory
and neurodegenerative human diseases.[1],[2]
About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company
developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana's
innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous
(IV) delivery. Tiziana's lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favorable
safety profile and clinical response in patients in studies to date. Tiziana's technology for alternative routes of immunotherapy
has been patented with several applications pending and is expected to allow for broad pipeline applications.
For further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
LifeSci Advisors, LLC
EXECUTIVE CHAIRMAN'S STATEMENT
I am pleased to report on the Group's financial
results for the six months ended 30 June 2023.
We have made strong progress advancing our pipeline
in the first half of the year.
After announcing our focus on the development
of intranasal foralumab in CNS-mediated inflammatory diseases at the end of last year, we began 2023 with a stream of continuous, positive
developments in these programs. Intranasal foralumab's unique action on regulatory T-cells, along with its potential to treat multiple
inflammatory-driven diseases, has been published in major medical journals and recognized in the media on multiple occasions. In September,
we also recently announced intranasal foralumab's progress in Alzheimer's disease with study data published in the Proceedings
of the National Academy of Sciences and clearance to proceed with clinical testing in this indication following an IND submission .
Our near-term strategic focus is to prioritize
resources for the clinical development of this unique therapeutic candidate, beginning with CNS focused indications, to maximize shareholder
value, while still maintaining optionality for our other research programs, including milciclib in oncology.
We remain steadfast towards our goal to become
a leading company pioneering intranasal therapies for inflammatory diseases.
Consolidated Statement of Comprehensive Income
for the six months ended 30 June 2023
| 6 months to | 6 months to | 12 months to | ||||||||||||||
| 30 June | 30 June | 31 Dec | ||||||||||||||
| Notes | 2023 | 2022 | 2022 | |||||||||||||
| $'000 | $'000 | $'000 | ||||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Research and development | (3,287 | ) | (7,463 | ) | (12,955 | ) | ||||||||||
| Operating expenses | 4 | (5,405 | ) | 2,950 | (1,631 | ) | ||||||||||
| Operating loss | (8,692 | ) | (4,513 | ) | (14,586 | ) | ||||||||||
| Finance expense | (5 | ) | - | (7 | ) | |||||||||||
| Other income/(losses) | 8 | 80 | - | (804 | ) | |||||||||||
| Total Other income/expense | 75 | - | (811 | ) | ||||||||||||
| Operating loss before taxation | (8,617 | ) | (4,513 | ) | (15,397 | ) | ||||||||||
| Taxation | - | - | - | |||||||||||||
| Loss for the period | (8,617 | ) | (4,513 | ) | (15,397 | ) | ||||||||||
| Net loss for the period attributable to equity owners | (8,617 | ) | (4,513 | ) | (15,397 | ) | ||||||||||
| Other comprehensive income for the period Items that may be reclassified to profit or loss | ||||||||||||||||
| Translation of foreign operations | 1,697 | (3,767 | ) | (3,582 | ) | |||||||||||
| Total comprehensive loss attributable to equity owners | (6,920 | ) | (8,280 | ) | (18,979 | ) | ||||||||||
| Earnings per share | ||||||||||||||||
| Basic and diluted loss per share on continuing operations | $ | (0.08 | ) | $ | (0.05 | ) | $ | (0.15 | ) |
Consolidated Statement of Financial Position
| 30 June | 30 June | 31 Dec | ||||||||||||||
| Notes | 2023 | 2022 | 2022 | |||||||||||||
| $'000 | $'000 | $'000 | ||||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
| Assets | ||||||||||||||||
| Non-Current assets: | ||||||||||||||||
| Property, plant and equipment, net | 13 | 13 | 17 | |||||||||||||
| Intangible asset | - | 118 | - | |||||||||||||
| Investment in related party | 8 | 1,886 | 2,676 | 1,806 | ||||||||||||
| Right-of-use assets | 9 | 338 | - | 372 | ||||||||||||
| Total Non-current assets | 2,237 | 2,807 | 2,195 | |||||||||||||
| Currents assets: | ||||||||||||||||
| Prepayments and Other receivable | 691 | 871 | 300 | |||||||||||||
| Related party receivables | 3,647 | 608 | 1,614 | |||||||||||||
| Taxation receivable | 4,246 | 4,296 | 4,246 | |||||||||||||
| Cash and cash equivalents | 6,597 | 26,543 | 18,122 | |||||||||||||
| Total current assets | 15,181 | 32,318 | 24,282 | |||||||||||||
| Total assets | 17,418 | 35,125 | 26,477 | |||||||||||||
| Equity and liabilities | ||||||||||||||||
| Shareholder's equity: | ||||||||||||||||
| Called up share capital (102,272,614 shares are issued and outstanding) | 102 | 102 | 102 | |||||||||||||
| Share premium | 15,596 | 15,596 | 15,596 | |||||||||||||
| Share based payment reserve - options | 6,088 | 11,453 | 5,190 | |||||||||||||
| Shares based payment reserve - Warrants | 697 | 697 | 697 | |||||||||||||
| Merger relief reserve | 118,697 | 118,697 | 118,697 | |||||||||||||
| Treasury shares | (1,574 | ) | (808 | ) | (1,320 | ) | ||||||||||
| Translation reserve | (1,431 | ) | (3,316 | ) | (3,128 | ) | ||||||||||
| Retained earnings | (124,880 | ) | (112,574 | ) | (116,263 | ) | ||||||||||
| Equity attributed to the owners of the Company | 13,295 | 29,847 | 19,571 | |||||||||||||
| Current liabilities: | ||||||||||||||||
| Accounts payable and accrued expenses | 3,764 | 5,270 | 6,532 | |||||||||||||
| Lease liability | 9 | 170 | - | 122 | ||||||||||||
| Other liabilities | 6 | 8 | 9 | |||||||||||||
| 3,940 | 5,278 | 6,663 | ||||||||||||||
| Long term liabilities: | ||||||||||||||||
| Lease Liability | 9 | 183 | - | 243 | ||||||||||||
| Total Liabilities | 4,123 | 5,278 | 6,906 | |||||||||||||
| Total Equity and Liabilities | 17,418 | 35,125 | 26,477 |
Consolidated Statement of Cash Flows
for the 6 months ended 30 June 2023
| 6 months to | 6months to | 12 months to | ||||||||||
| 30 June | 30 June | 31 December | ||||||||||
| 2023 | 2022 | 2022 | ||||||||||
| $'000 | $'000 | $'000 | ||||||||||
| (unaudited) | (unaudited) | |||||||||||
| Cash flows from operating activities | ||||||||||||
| Operating loss for the period before tax | (8,617 | ) | (4,513 | ) | (15,397 | ) | ||||||
| Share based payment - options | 917 | (2,344 | ) | 1,811 | ||||||||
| Depreciation | 4 | 5 | 1 | |||||||||
| FV movement on investment | (80 | ) | - | 869 | ||||||||
| (Gain)/Loss on foreign exchange | 1,540 | (3,681 | ) | (3,183 | ) | |||||||
| Depreciation of right of use asset | 51 | - | 50 | |||||||||
| Options forfeited during the year | (19 | ) | - | (3,221 | ) | |||||||
| Loss on disposal of asset | - | - | 129 | |||||||||
| Cash inflow from taxation | - | 440 | 490 | |||||||||
| Net (increase) in related party receivables | (2,033 | ) | (153 | ) | (1,158 | ) | ||||||
| Net (decrease)/increase in related party payables | - | (1,355 | ) | (1,355 | ) | |||||||
| Net (increase)/decrease in operating assets/other receivables | (389 | ) | 603 | 1,002 | ||||||||
| Net (decrease)/ increase in operating liabilities/other liabilities | (2,766 | ) | (915 | ) | 347 | |||||||
| Net cash used in operating activities | (11,392 | ) | (11,913 | ) | (19,615 | ) | ||||||
| Cash flow from financing activities | ||||||||||||
| Repayment of leasing liabilities | (37 | ) | - | (55 | ) | |||||||
| Net cash used in financing activities | (37 | ) | - | (55 | ) | |||||||
| Cash flows from investing activities | ||||||||||||
| Investment in Related Party | - | (2,675 | ) | (2,676 | ) | |||||||
| Purchase of Treasury Shares | (254 | ) | (808 | ) | (1,320 | ) | ||||||
| Net cash (outflow)/inflow from investing activities | (254 | ) | (3,483 | ) | 3,996 | |||||||
| Net decrease in cash and cash equivalents | (11,683 | ) | (15,643 | ) | (23,666 | ) | ||||||
| Cash and cash equivalents at beginning of period | 18,122 | 42,186 | 42,186 | |||||||||
| Exchange difference | 158 | 247 | (398 | ) | ||||||||
| Cash and cash equivalents at end of period | 6,597 | 26,543 | 18,122 |
Consolidated Statement of Changes in Equity -
for the six months ended 30 June 2023
| (Unaudited) | Share Capital | Share Premium | Share Based Payment Reserve (Options) | Share Based Payment Reserve (Warrants) | Merger Reserve | Treasury Shares | Translation Reserve | Retained Earnings | Total Equity | |||||||||||||||||||||||||||
| $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | ||||||||||||||||||||||||||||
| Balance at 1 January 2023 | 102 | 15,596 | 5,190 | 697 | 118,697 | (1,320 | ) | (3,128 | ) | (116,263 | ) | 19,571 | ||||||||||||||||||||||||
| Purchase of Treasury Shares | - | - | - | - | - | (254 | ) | - | - | (254 | ) | |||||||||||||||||||||||||
| Share based payments charge (options) | - | - | 917 | - | - | - | - | - | 917 | |||||||||||||||||||||||||||
| Options forfeited in the year | - | - | (19 | ) | - | - | - | - | - | (19 | ) | |||||||||||||||||||||||||
| Total transactions with owners | - | - | 898 | - | - | (254 | ) | - | - | 644 | ||||||||||||||||||||||||||
| Comprehensive income | ||||||||||||||||||||||||||||||||||||
| Loss for the period | - | - | - | - | - | - | - | (8,617 | ) | (8,617 | ) | |||||||||||||||||||||||||
| Foreign currency translation | - | - | - | - | - | - | 1,697 | - | 1,697 | |||||||||||||||||||||||||||
| Total comprehensive income | - | - | - | - | - | - | 1,697 | (8,617 | ) | (6,920 | ) | |||||||||||||||||||||||||
| Balance at 30 June 2023 | 102 | 15,596 | 6,088 | 697 | 118,697 | (1,574 | ) | (1,431 | ) | (124,880 | ) | 13,295 |
Consolidated Statement of Changes in Equity -
for the period ended 30 June 2022
| (Unaudited) | Share Capital | Share Premium | Share Based Payment Reserve (Options) | Share Based Payment Reserve (Warrants) | Merger Reserve | Treasury Shares | Translation Reserve | Retained Earnings | Total Equity | |||||||||||||||||||||||||||
| $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | ||||||||||||||||||||||||||||
| Balance at 1 January 2022 | 102 | 15,596 | 13,797 | 697 | 118,697 | - | 454 | (108,061 | ) | 41,280 | ||||||||||||||||||||||||||
| Purchase of Treasury Shares | - | - | - | - | - | (808 | ) | - | - | (808 | ) | |||||||||||||||||||||||||
| Share based payments charge (options) | - | - | 2,344 | - | - | - | - | - | 2,344 | |||||||||||||||||||||||||||
| Total transactions with owners | - | - | 2,344 | - | - | (808 | ) | - | - | 1,536 | ||||||||||||||||||||||||||
| Comprehensive income | ||||||||||||||||||||||||||||||||||||
| Loss for the period | - | - | - | - | - | - | - | (4,513 | ) | (4,513 | ) | |||||||||||||||||||||||||
| Foreign currency translation | - | - | - | - | - | - | (3,767 | ) | - | (3,767 | ) | |||||||||||||||||||||||||
| Total comprehensive income | - | - | - | - | - | - | (3,767 | ) | (4,513 | ) | (8,280 | ) | ||||||||||||||||||||||||
| Balance at 30 June 2022 | 102 | 15,596 | 11,453 | 697 | 118,697 | (808 | ) | (3,316 | ) | (112,574 | ) | 29,847 |
Consolidated Statement of Changes in Equity -
for the year ended 31 December 2022
| Share Capital | Share Premium | Share Based Payment Reserve (Options) | Share Based Payment Reserve (Warrants) | Merger Reserve | Treasury Shares | Translation Reserve | Retained Earnings | Total Equity | ||||||||||||||||||||||||||||
| $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | ||||||||||||||||||||||||||||
| Balance as at 31 December 2021 | 102 | 15,596 | 13,797 | 697 | 118,697 | - | 454 | (108,063 | ) | 41,280 | ||||||||||||||||||||||||||
| Issue of share capital | ||||||||||||||||||||||||||||||||||||
| Treasury Shares | - | - | - | - | - | (1,320 | ) | - | - | (1,320 | ) | |||||||||||||||||||||||||
| Share based payment charge (options) | - | - | 1,811 | - | - | - | - | - | 1,811 | |||||||||||||||||||||||||||
| Options forfeited in the year | - | - | (3,221 | ) | - | - | - | - | - | (3,221 | ) | |||||||||||||||||||||||||
| Reclass of FV for options forfeited/Cancelled | (7,197 | ) | 7,197 | - | ||||||||||||||||||||||||||||||||
| Transactions with Owners | - | (8,607 | ) | - | - | (1,320 | ) | - | 7,197 | (2,730 | ) | |||||||||||||||||||||||||
| Comprehensive lncome | ||||||||||||||||||||||||||||||||||||
| Loss of the period | - | - | - | - | - | - | - | (15,397 | ) | (15,397 | ) | |||||||||||||||||||||||||
| Foreign currency translation | - | - | - | - | - | (3,582 | ) | - | (3,582 | ) | ||||||||||||||||||||||||||
| Total comprehensive income | - | - | - | - | - | - | (3,582 | ) | (15,397 | ) | (18,979 | ) | ||||||||||||||||||||||||
| Balance as at 31 December 2022 | 102 | 15,596 | 5,190 | 697 | 118,697 | (1,320 | ) | (3,128 | ) | (116,263 | ) | 19,571 |
Notes to the Interim Financial Statements
for the six month period to 30 June 2023
Tiziana Life Sciences Ltd is a public limited
company incorporated in Bermuda and is listed on the NASDAQ Capital Market (NASDAQ: TLSA). The address of its registered office is Clarendon
House, 2 Church Street, Hamilton HM 11, Bermuda. The principal activities of the Company and its subsidiaries (the Group) are that of