Full Press Release Details
Tiziana Life Sciences Ltd
("Tiziana" or "the Company")
Update and Interim Results for the Six Months
MA, October 3, 2025 - Tiziana Life Sciences, Ltd. (Nasdaq: TLSA)
("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies with
its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today filed its interim financial results
for the six months ended June 30, 2025, and provided a corporate update on its lead programs in development.
EXECUTIVE CHAIRMAN'S STATEMENT
We are pleased to present to you the interim results
for Tiziana Life Sciences for the six months ended June 30, 2025. Over this period, we have made significant progress across our pipeline,
advanced key clinical programs, and strengthened our strategic foundation, all while staying focused on our mission to deliver transformative
treatments for patients with unmet medical needs.
Strategic Progress and Clinical Advancements
The past six months have marked important milestones
in the development of our innovative therapeutic candidates. Our lead asset, foralumab, continues to demonstrate encouraging clinical
activity in neurodegenerative and autoimmune diseases. In particular, our expanded access program for multiple sclerosis (MS) has provided
further evidence supporting its potential to reshape treatment paradigms in this area.
We have made substantial progress in enrolling
our Phase 2 trial of intranasal foralumab for non-active (non-relapsing) Secondary Progressive Multiple Sclerosis. Positive early data
from our MS expanded access studies highlight the promise of our intranasal delivery approach, which may offer patients improved efficacy
with a more favourable safety and tolerability profile compared to conventional therapies. In addition, dosing has commenced in our Phase
2 clinical trial for Multiple System Atrophy (MSA), and our expanded access program for moderate Alzheimer's disease is ongoing.
Importantly, the FDA's previous Fast Track
designation for intranasal foralumab underscores its potential as a therapy addressing serious conditions with unmet medical need. This
designation provides us with an accelerated regulatory pathway and increased engagement with the FDA, enhancing our ability to bring innovative
treatments to patients more efficiently.
Expansion to Boston, Massachusetts
In line with our strategy to strengthen our U.S.
presence, we are delighted to announce the opening of our new office in Boston, Massachusetts. Boston is one of the world's most
vibrant biotechnology hubs, offering access to a thriving ecosystem of research, innovation, and talent. Our office is located in close
proximity to Brigham and Women's Hospital, a key research site for our intranasal foralumab program. This strategic location will
enable us to deepen our collaborations, facilitate clinical trial execution, and further embed Tiziana within a community that is driving
advances in neuroscience and immunology.
We have continued to exercise disciplined financial
management while prioritizing investment in our most promising programs. The non-dilutive funding secured during this reporting period
has strengthened our balance sheet and provides us with the resources to advance our pipeline and expand our R&D capabilities. At
the same time, we remain focused on operational efficiency and sustainability in light of the broader economic environment. Strategic
partnerships and collaborations remain a key part of our growth strategy, enabling us to unlock additional value and accelerate development.
First Half Financial Results (Unaudited)
six months ended June 30, 2025 Tiziana reported a total comprehensive loss of $5.3 million compared to $4.7 million for the same period
had $7.3 million in cash as of the six months ended 30 June 2025 as compared to $3.7 million on 31 December 2024. Additionally, Tiziana
had $5.3 million of other receivables as of the six months ended 30 June 2025 as compared to $3.8 million on 31 December 2024. Post the
period end, the Company has raised an additional $2m from the sale of investment shares and ATM issuances.
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 website at: https://ir.tizianalifesciences.com/financial-information/annual-reports.
Foralumab - First Half 2025 Key Developments
Image Source: Singhal T et al. Dampening of Microglial
Activation with Nasal Foralumab Administration in Moderate Alzheimer's Disease Dementia. Clinical Nuclear Medicine 2025 May 13.
doi: 10.1097/RLU.0000000000005955. Online ahead of print.
By mid-2025, Tiziana advanced Foralumab's clinical footprint
across MS, AD, ALS, TBI, and SCI, with major regulatory progress (IND submission for ALS, FDA EA program expansion) and multiple high-profile
peer-reviewed publications (Nature Reviews Neurology, Nature Neuroscience, Clinical Nuclear Medicine).
Post period end clinical highlights (July-September 2025)
Reflecting on our achievements so far in 2025,
we are energized by the progress we have made and the opportunities that lie ahead. The clinical advancements with foralumab, combined
with our strategic expansion into Boston, reinforce our confidence in the strength of our platform and our ability to deliver meaningful
therapies to patients.
I would like to extend my gratitude to our shareholders for their ongoing
support, to our scientific advisors for their invaluable guidance, and most importantly, to the Tiziana team for their dedication and
commitment to our mission. Together, we are building momentum toward our vision of transforming treatment options for patients living
with neurodegenerative and autoimmune diseases.
Thank you for your continued trust and support.
Executive Chairman and Founder
Tiziana Life Sciences
For more information about Tiziana Life Sciences and its innovative
pipeline of therapies, please visit www.tizianalifesciences.com.
Forward-Looking Statements
Certain statements made in this filing are forward-looking statements.
These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections
about its industry, its beliefs, and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,'
and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance
and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult
to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements.
The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements,
which reflect the view of the Company only as of the date of this filing. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and
other factors described more fully in the section entitled Risk Factors' in Tiziana's Annual Report on Form 20-F for
the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. The forward-looking statements
made in this filing relate only to events as of the date on which the statements are made. The Company will not undertake any obligation
to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events
occurring after the date of this filing except as required by law or by any appropriate regulatory authority.
Consolidated Statement of Comprehensive Income
for the six months ended 30 June 2025
| 6 months | 6 months | |||||||||||||||
| to 30 June | to 30 June | 12 months | ||||||||||||||
| 2025 | 2024 | to 31 Dec | ||||||||||||||
| $'000 | $'000 | 2024 | ||||||||||||||
| Notes | (Unaudited) | (Unaudited) | $'000 | |||||||||||||
| Research and development | (3,243 | ) | (2,576 | ) | (5,229 | ) | ||||||||||
| Operating expenses | (5,943 | ) | (3,931 | ) | (10,565 | ) | ||||||||||
| Operating loss | (9,186 | ) | (6,507 | ) | (15,794 | ) | ||||||||||
| Interest income | 5 | 112 | 814 | |||||||||||||
| Other income | 521 | - | - | |||||||||||||
| FV Gain/(Loss) on Investment | 8 | 3,028 | (1,585 | ) | (1,766 | ) | ||||||||||
| Total Other income/expense | 3,554 | (1,473 | ) | (952 | ) | |||||||||||
| Operating loss before taxation | (5,632 | ) | (7,980 | ) | (16,746 | ) | ||||||||||
| Taxation | - | 3,326 | 4,883 | |||||||||||||
| Loss for the period | (5,632 | ) | (4,654 | ) | (11,863 | ) | ||||||||||
| Net loss for the period attributable to equity owners | (5,632 | ) | (4,654 | ) | (11,863 | ) | ||||||||||
| Other comprehensive income for the period | - | - | - | |||||||||||||
| Items that may be reclassified to profit or loss | ||||||||||||||||
| Translation of foreign operations | 339 | (72 | ) | (72 | ) | |||||||||||
| Total comprehensive loss attributable to equity owners | (5,293 | ) | (4,726 | ) | (11,935 | ) | ||||||||||
| Earnings per share | ||||||||||||||||
| Basic and diluted loss per share on continuing operations | $ | (0.05 | ) | $ | (0.04 | ) | $ | (0.11 | ) |
Consolidated Statement of Financial Position
| 30 June | 30 June | |||||||||||||||
| 2025 | 2024 | 31 Dec | ||||||||||||||
| $'000 | $'000 | 2024 | ||||||||||||||
| Notes | (unaudited) | (unaudited) | $'000 | |||||||||||||
| Assets | ||||||||||||||||
| Non-Current assets: Property, plant and equipment, net | 18 | 16 | 16 | |||||||||||||
| Investment in related party | 8 | 3,731 | 2,969 | 3,589 | ||||||||||||
| Right-of-use assets | 9 | 132 | 229 | 171 | ||||||||||||
| Total non-current assets | 3,881 | 3,214 | 3,776 | |||||||||||||
| Currents assets: | ||||||||||||||||
| Prepayments and Other receivable | 517 | 355 | 145 | |||||||||||||
| Related party receivables | 4,876 | 2,850 | 3,607 | |||||||||||||
| Taxation receivable | 72 | 3,415 | 32 | |||||||||||||
| Cash and cash equivalents | 7,251 | 1,130 | 3,724 | |||||||||||||
| Total current assets | 12,716 | 7,750 | 7,508 | |||||||||||||
| Total assets | 16,597 | 10,964 | 11,284 | |||||||||||||
| Equity and liabilities | ||||||||||||||||
| Shareholder's equity: | ||||||||||||||||
| Called up share capital (118,824,007) shares are issued and outstanding) | 119 | 104 | 111 | |||||||||||||
| Share premium | 31,788 | 16,914 | 23,105 | |||||||||||||
| Share based payment reserve - options | 8,248 | 7,694 | 7,626 | |||||||||||||
| Shares based payment reserve - warrants | 86 | - | 25 | |||||||||||||
| Merger relief reserve | 118,698 | 118,698 | 118,697 | |||||||||||||
| Treasury shares | - | (1,573 | ) | - | ||||||||||||
| RSU Reserve | 2,094 | - | 910 | |||||||||||||
| Translation reserve | (1,370 | ) | (1,711 | ) | (1,707 | ) | ||||||||||
| Retained earnings | (150,463 | ) | (138,271 | ) | (144,831 | ) | ||||||||||
| Equity attributed to the owners of the Company | 9,200 | 1,855 | 3,936 | |||||||||||||
| Current liabilities: | ||||||||||||||||
| Accounts payable and accrued expenses | 7 | 7,177 | 8,922 | 7,230 | ||||||||||||
| Lease liability | 9 | 107 | 142 | 106 | ||||||||||||
| Tax Liability | 104 | - | - | |||||||||||||
| Other liabilities | 9 | 8 | 12 | |||||||||||||
| 7,397 | 9,072 | 7,348 | ||||||||||||||
| Long term liabilities: | ||||||||||||||||
| Lease Liability | 9 | - | 37 | - | ||||||||||||
| Total Liabilities | 7,397 | 9,109 | 7,348 | |||||||||||||
| Total Equity and Liabilities | 16,597 | 10,964 | 11,284 |
Consolidated Statement of Cash Flows
for the six months ended 30 June 2025
| 6 months to | 6months to | |||||||||||||||
| 30 June | 30 June | 12 months to | ||||||||||||||
| 2025 | 2024 | 31 December | ||||||||||||||
| $'000 | $'000 | 2024 | ||||||||||||||
| (unaudited) | (unaudited) | $'000 | ||||||||||||||
| Cash flows from operating activities | ||||||||||||||||
| Operating loss for the period before tax | (5,632 | ) | (7,980 | ) | (16,746 | ) | ||||||||||
| Share Issuance in lieu of fees and bonus | 1,344 | 199 | 1,613 | |||||||||||||
| Shares issued in lieu of consultancy fees | - | - | 1,788 | |||||||||||||
| Share based payment - restricted stock units | 1,185 | - | 910 | |||||||||||||
| Share based payment - options | 623 | 885 | 1,656 | |||||||||||||
| Options forfeited during the year | (1 | ) | (36 | ) | (227 | ) | ||||||||||
| Depreciation | 5 | 8 | 12 | |||||||||||||
| FV movement on investment | 8 | (2,613 | ) | 1,585 | 1,760 | |||||||||||
| (Gain)/Loss on foreign exchange | 230 | 64 | 158 | |||||||||||||
| (Gain)/loss on disposal of assets | (415 | ) | - | 1 | ||||||||||||
| Depreciation of right of use asset | 83 | 54 | 112 | |||||||||||||
| Cash inflow from taxation | 64 | 3,937 | 8,784 | |||||||||||||
| Net (increase) in related party receivables | (1,269 | ) | (713 | ) | (1,469 | ) | ||||||||||
| Interest on related party loan conversion | - | - | (795 | ) | ||||||||||||
| Net (increase)/decrease in operating assets/other receivables | (372 | ) | (131 | ) | 78 | |||||||||||
| Net (decrease)/ increase in operating liabilities/other liabilities | (55 | ) | 2,528 | 839 | ||||||||||||
| Net cash generated by/(used in) operating activities | (6,823 | ) | 400 | (1.526 | ) | |||||||||||
| Cash flow from financing activities | ||||||||||||||||
| Proceeds from issuance of ordinary shares, net | 7,408 | - | 4,571 | |||||||||||||
| Proceeds from exercise of options | - | - | 75 | |||||||||||||
| Repayment of leasing liabilities | (48 | ) | (69 | ) | (141 | ) | ||||||||||
| Net cash generated by /(used in) financing activities | 7,360 | (69 | ) | 4,505 | ||||||||||||
| Cash flows from investing activities | ||||||||||||||||
| Purchase of PPE | (6 | ) | (14 | ) | (19 | ) | ||||||||||
| Proceeds on sale of investment shares, net | 8 | 2,886 | - | - | ||||||||||||
| Purchase of Treasury Shares | - | - | (52 | ) | ||||||||||||
| Net cash generated by/ (used in) investing activities | 2,880 | (14 | ) | (71 | ) | |||||||||||
| Net increase in cash and cash equivalents | 3,417 | 317 | 2,908 | |||||||||||||
| Cash and cash equivalents at beginning of period | 3,724 | 1,183 | 1,183 | |||||||||||||
| Exchange difference | 110 | (370 | ) | (367 | ) | |||||||||||
| Cash and cash equivalents at end of period | 7,251 | 1,130 | 3,724 |
Consolidated Statement of Changes in Equity -
for the six months ended 30 June 2025
| Share Capital | Share Premium | Share Based Payment Reserve (Options) | Shares Based Payment Reserve (Warrants) | Merger Reserve | RSU Reserve | Translation Reserve | Retained Earnings | Total Equity | ||||||||||||||||||||||||||||
| (Unaudited) | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | |||||||||||||||||||||||||||
| Balance at 1 January 2025 | 111 | 23,105 | 7,626 | 25 | 118,698 | 910 | (1,708 | ) | (144,831 | ) | 3,936 | |||||||||||||||||||||||||
| Share based payments charge (options) | - | - | 623 | - | - | - | - | - | 623 | |||||||||||||||||||||||||||
| Options forfeited in the year | - | - | (1 | ) | - | - | - | - | - | (1 | ) | |||||||||||||||||||||||||
| Warrants Charged in the Year | - | (61 | ) | - | 61 | - | - | - | - | - | ||||||||||||||||||||||||||
| Proceeds from issuance of ordinary shares - Fundraise, net | 7 | 7,401 | - | - | - | - | - | - | 7,408 | |||||||||||||||||||||||||||
| Shares issued in lieu of directors' bonus | 1 | 1,343 | - | - | - | - | - | - | 1,344 | |||||||||||||||||||||||||||
| RSU Reserve | - | - | - | - | - | 1,184 | - | - | 1,184 | |||||||||||||||||||||||||||
| Total transactions with owners | 8 | 8,683 | 622 | 61 | - | 1,184 | - | - | 10,588 | |||||||||||||||||||||||||||
| Comprehensive income | ||||||||||||||||||||||||||||||||||||
| Loss for the period | - | - | - | - | - | - | - | (5,632 | ) | (5,632 | ) | |||||||||||||||||||||||||
| Foreign currency translation | - | - | - | - | - | - | 338 | - | 338 | |||||||||||||||||||||||||||
| Total comprehensive income | - | - | - | - | - | - | 338 | (5,632 | ) | (5,294 | ) | |||||||||||||||||||||||||
| Balance at 30 June 2025 | 119 | 31,788 | 8,248 | 86 | 118,698 | 2,094 | (1,370 | ) | (150,463 | ) | 9,200 |
Consolidated Statement of Changes in Equity -
for the six months ended 30 June 2024
| Share Capital | Share Premium | Share Based Payment Reserve (Options) | Share Based Payment Reserve (Warrants) | Merger Reserve | Treasury Shares | Translation Reserve | Shares to be issued Reserve | Retained Earnings | Total Equity | |||||||||||||||||||||||||||||||
| (Unaudited) | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | ||||||||||||||||||||||||||||||
| Balance at 1 January 2024 | 103 | 16,492 | 6,905 | - | 118,698 | (1,574 | ) | (1,636 | ) | 225 | (133,676 | ) | 5,536 | |||||||||||||||||||||||||||
| Purchase of Treasury Shares | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||
| Share based payments charge (options) | - | - | 885 | - | - | - | - | - | - | 885 | ||||||||||||||||||||||||||||||
| Options forfeited in the year | - | - | (95 | ) | - | - | - | - | - | 59 | (36 | ) | ||||||||||||||||||||||||||||
| Shares issued in lieu of directors fee and cash bonus | 1 | 326 | - | - | - | - | - | (225 | ) | - | 102 | |||||||||||||||||||||||||||||
| Shares issued in lieu of consultancy fees | - | 97 | - | - | - | - | - | - | - | 97 | ||||||||||||||||||||||||||||||
| Total transactions with owners | 1 | 423 | 790 | - | - | - | - | (225 | ) | 59 | 1,048 | |||||||||||||||||||||||||||||
| Comprehensive income | ||||||||||||||||||||||||||||||||||||||||
| Loss for the period | - | - | - | - | - | - | - | - | (4,654 | ) | (4,654 | ) | ||||||||||||||||||||||||||||
| Foreign currency translation | - | - | - | - | - | - | (72 | ) | - | - | (72 | ) | ||||||||||||||||||||||||||||
| Total comprehensive income | - | - | - | - | - | - | (72 | ) | - | (4,654 | ) | (4,726 | ) | |||||||||||||||||||||||||||
| Balance at 30 June 2024 | 104 | 16,915 | 7,695 | - | 118,698 | (1,574 | ) | (1,708 | ) | - | (138,271 | ) | 1,858 |
Consolidated Statement of Changes in Equity -
for the year ended 31 December 2024
| Share Capital | Share Premium | Share Based Payment Reserve (Options) | Share Based Payment Reserve (Warrants) | Merger Reserve | Treasury Shares | RSU | Translation Reserve | Shares to be issued Reserve | Retained Earnings | Total Equity | ||||||||||||||||||||||||||||||||||
| $'000 | $'000 | $'000 | $'000 | $'000 | $'000 | Reserve | $'000 | $'000 | $'000 | $'000 | ||||||||||||||||||||||||||||||||||
| Balance as at 31 December 2023 | 103 | 16,492 | 6,905 | - | 118,698 | (1,574 | ) | - | (1,636 | ) | 225 | (133,676 | ) | 5,536 | ||||||||||||||||||||||||||||||
| Share based payment charge (options) | - | - | 1,656 | - | - | 1,656 | ||||||||||||||||||||||||||||||||||||||
| Options forfeited/cancelled in the year | - | - | (875 | ) | - | - | - | - | - | - | 708 | (167 | ) | |||||||||||||||||||||||||||||||
| Options exercised in the year | - | 75 | (60 | ) | - | - | - | - | - | - | - | 15 | ||||||||||||||||||||||||||||||||
| Warrants charge | - | (25 | ) | - | 25 | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||
| Buyback and cancellation of Treasury Shares | (2 | ) | (1,623 | ) | - | - | - | 1,574 | - | - | - | - | (51 | |||||||||||||||||||||||||||||||
| Shares issued in lieu of directors fees, bonus and Expenses | 3 | 1,835 | - | - | - | - | - | - | (225 | ) | - | 1,613 | ||||||||||||||||||||||||||||||||
| Shares issued in lieu of Consultancy Fees | 2 | 1,785 | - | - | - | - | - | - | - | - | 1,787 | |||||||||||||||||||||||||||||||||
| Net Shares issued for ATM | - | 124 | - | - | - | - | - | - | - | - | 124 | |||||||||||||||||||||||||||||||||
| Net Shares issued for fundraising | 5 | 4,442 | - | - | - | - | - | - | - | - | 4,447 | |||||||||||||||||||||||||||||||||
| Restricted Shares | - | - | - | - | - | - | 910 | - | 910 | |||||||||||||||||||||||||||||||||||
| Total transactions with owners | 8 | 6,613 | 721 | 25 | - | 1,574 | 910 | - | (225 | ) | 708 | 10,334 | ||||||||||||||||||||||||||||||||
| Loss for Period | - | - | - | - | - | - | - | - | - | (11,863 | ) | (11,863 | ) | |||||||||||||||||||||||||||||||
| Translation | - | - | - | - | - | - | - | (72 | ) | - | - | (72 | ) | |||||||||||||||||||||||||||||||
| Total comprehensive loss | - | - | - | - | - | - | - | (72 | ) | - | (11,863 | ) | (11,935 | ) | ||||||||||||||||||||||||||||||
| Balance as at 31 December 2024 | 111 | 23,105 | 7,626 | 25 | 118,698 | - | 910 | (1,708 | ) | - | (144,831 | ) | 3,936 |
Notes to the Interim Financial Statements
for the six month period to 30 June 2025