TIZIANA LIFE SCIENCES LTD Tiziana Life Sciences Ltd
("Tiziana" or "the Company")
Updated Interim Results for the Six Months Ended 30 June 2023
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 theseprograms. Intranasal foralumab's unique action on regulatory T-cells,along with its potential to treat multiple inflammatory-drivendiseases, 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."
Mr. Cerrone continued, "Our near-term strategic focus is to prioritize resources for the clinical development ofthis 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
In January:
- Tiziana announced that the second patient ("EA2") in its Expanded Access trial receiving intranasal foralumab to treat non-active secondary progressive multiple sclerosis (na-SPMS) showed additional clinical improvements since the patient's last reported improvement inSeptember 2022. The improvements were measured by the Expanded Disability Status Scale (EDSS), aU.S. Food and Drug Administration (FDA) - recognized standard clinical outcome assessment.
In March:
Tiziana announced 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 naïve-likeT 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-CD3mAb represents a novel avenue for treatment of inflammatory human diseases. The publication can be found athttps://www.pnas.org/doi/10.1073/pnas.2220272120.
- As a result of this publication, Dr. Tanuja Chitnis, M.D., Professor of Neurology at Brigham Women's Hospital, a founding member ofMass General Brigham Healthcare System, and lead investigator of the study, noted that foralumab also "makes a promising therapeutic candidate for several rare Orphan pediatric neuroinflammatory diseases, which currently remain untreated."
- Tiziana announced its intention to start a Phase 2a study in the third quarter of 2023 in patients with na- SPMS employing intranasal foralumab, which it then began in September with the initiation of its first clinical site. Tiziana expects to conduct the Phase 2a study at six to ten clinical sites and dosed its first patient in December..
- Tiziana announced data from a pre-clinical study on the effects of intranasal foralumab in Alzheimer's disease which were presented on April 1, 2023, at the International Conference on Alzheimer's and Parkinson's Disease and Related Neurological Disorders by Dr. Howard Weiner, M.D., Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women's Hospital. The data showed reduction of microglia activation and improvement in behavior in animal models of Alzheimer's disease. In September, these data were published in the journal, Proceedings of the National Academy of Sciences (PNAS). The publication can be found at https://www.pnas.org/doi/10.1073/pnas.2309221120.
- Additionally, Tiziana's foralumab was highlighted in aForbesmagazine articleentitled "New T Cell Antibody Treatment Improves Outcomes for Covid Patients" authored by contributing author, thought leader and pioneer in genomic sciences, William A. Haseltine, who stated "Foralumab induces many factors that impact improved tissue remodeling, induction of immune cells, and restriction of effector function, improving disease outcomes while fighting the virus to full strength. These benefits are not limited to COVID-19patients, as similar results were observed in patients with multiple sclerosis."
In April:
- Tiziana announced data from a pre-clinical study on the effects of intranasal foralumab in intracerebral hemorrhage (hemorrhagic stroke) that demonstrated one-month behavioral outcomes improvement and modulation of neuroinflammation. These data were presented in a podium presentation by Dr. Saef Izzy, M.D., MBCHB, Assistant Professor of Neurology at Harvard Medical School on April 23, 2023, at the American Academy of Neurology (AAN) annual meeting.
- Tiziana plans to investigate intranasal foralumab for the treatment of Long COVID. The work is supported by foralumab's well-established role in de-activating microglia cells, a key component in the pathogenesis of this disease.
In June:
- The Company announced a reduction in microglial activation as seen in three-month Positron Emission Tomography (PET) scans - in a total of five of the six patients with non-activesecondary-progressive multiple sclerosis (na-SPMS) treated with intranasal foralumab in its Expanded Access program (EAP). Microglial activation is believed to play a prominent role in the pathogenesis of neuroinflammatory diseases - including multiple sclerosis, Alzheimer's disease and amyotrophic lateral sclerosis (ALS). In na-SPMS, microglia serve as the brain's immune cells, and their activation causes inflammation, which, in turn drives the neurodegeneration of brain cells. Specifically, during the inflammatory process associated with na-SPMS, activated microglia are involved in the destruction of myelin, the protective sheath covering of nerve fibers, and contribute to the formation of MS lesions.
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 toGabriele 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
In August:
- Tiziana announced that the FDA has cleared the Investigational New Drug (IND) application for intranasal foralumab to be studied in Alzheimer's disease. A Phase 2 trial is expected to begin in 2024.
In October:
- Tiziana announced that a reduction in activated microglia, as seen in six-month Positron Emission Tomography (PET) scans, has now been observed in a total of five of the six patients with non-activesecondary-progressive multiple sclerosis (na-SPMS) treated with intranasal foralumab in its EAP. Activated microglia are believed to play a prominent role in the pathogenesis of neuroinflammatory and neurodegenerative diseases including multiple sclerosis, Alzheimer's disease, and amyotrophic lateral sclerosis, or ALS.
- Tiziana announced six-month data showing positive clinical improvements related to Modified Fatigue Impact Scale (MFIS) scores and similar important clinical measures of physical function in foralumab-treated,non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients participating in its EAP. This result follows the previously announced positive six-month PET scan data which was presented at the 39th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2023.
- Tiziana announced patients in the multiple sclerosis intermediate-size patient population (EAP) may now take home and self-administer intranasal foralumab as part of the at-home dosing initiative. Patients will be trained in the use of the nasal device in accordance with FDA instructions. Delivery Device Training materials have been developed and refined in collaboration with the FDA. Tiziana considers this a significant milestone since the allowance of at-home dosing could improve compliance and patient outcomes for those participating in the program.
2023 First Half Financial Results
- For the six months ended June 30, 2023 Tiziana reported a loss of $6.9 million compared to $8.3 million for the same period in 2022.
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Tiziana had $6.6 million in cash as of the six months ended 30 June 2023 compared to $18.1 million on December 31, 2022. Additionally, Tiziana had $7.9 million of other receivables as of the six months ended 30 June 2023 compared to $5.9 million on December 31, 2022.
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.govor the Investors section of the Company's website at https://ir.tizianalifesciences.com/financial-information/annual-reports.
About Foralumab
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
Investors:
Irina Koffler
LifeSci Advisors, LLC 646.970.4681 ikoffler@lifesciadvisors.com
- https://www.pnas.org/doi/10.1073/pnas.2220272120
- https://www.pnas.org/doi/10.1073/pnas.2309221120
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.
Gabriele Cerrone
Consolidated Statement of Comprehensive Income for the six months ended 30 June 2023
Notes | 6 months | 6 months | 12 months | |
to 30 June | to 30 June | to 31 Dec | ||
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
Taxation
Loss for the period
Net loss for the period attributable to equity owners
Other comprehensive income for the period Items that may be reclassified to profit or loss Translation of foreign operations
(8,617) | (4,513) | (15,397) |
- | - | - |
(8,617) | (4,513) | (15,397) |
(8,617) | (4,513) | (15,397) |
1,697 (3,767) (3,582)
Total comprehensive loss attributable to | (6,920) | (8,280) | (18,979) |
equity owners |
Earnings per share | |||
Basic and diluted loss per share on | |||
continuing operations | $(0.08) | $(0.05) | $(0.15) |
Consolidated Statement of Financial Position as at 30 June 2023
Notes
Assets | |
Non-Current assets: | |
Property, plant and equipment, net | |
Intangible asset | |
Investment in related party | 8 |
Right-of-use assets | 9 |
Total Non-current assets | |
Currents assets: | |
Prepayments and Other receivable | |
Related party receivables | |
Taxation receivable | |
Cash and cash equivalents | |
Total current assets | |
Total assets | |
Equity and liabilities | |
Shareholder's equity: | |
Called up share capital (102,272,614 | |
shares are issued and outstanding) | |
Share premium | |
Share based payment reserve - options | |
Shares based payment reserve - Warrants | |
Merger relief reserve | |
Treasury shares | |
Translation reserve | |
Retained earnings | |
Equity attributed to the owners of the | |
Company | |
Current liabilities: | |
Accounts payable and accrued expenses | |
Lease liability | 9 |
Other liabilities | |
Long term liabilities: | |
Lease Liability | 9 |
Total Liabilities
Total Equity and Liabilities
30 June | 30 June | 31 Dec |
2023 | 2022 | 2022 |
$'000 | $'000 | $'000 |
(unaudited) | (unaudited) |
13 | 13 | 17 |
- | 118 | - |
1,886 | 2,676 | 1,806 |
338 | - | 372 |
2,237 | 2,807 | 2,195 |
691 | 871 | 300 |
3,647 | 608 | 1,614 |
4,246 | 4,296 | 4,246 |
6,597 | 26,543 | 18,122 |
15,181 | 32,318 | 24,282 |
17,418 | 35,125 | 26,477 |
102 | 102 | 102 |
15,596 | 15,596 | 15,596 |
6,088 | 11,453 | 5,190 |
697 | 697 | 697 |
118,697 | 118,697 | 118,697 |
(1,574)) | (808) | (1,320) |
(1,431)) | (3,316) | (3,128) |
(124,880)) | (112,574) | (116,263)) |
13,295 | 29,847 | 19,571 |
3,764 | 5,270 | 6,532 |
170 | - | 122 |
6 | 8 | 9 |
3,940 | 5,278 | 6,663 |
183 | - | 243 |
4,123 | 5,278 | 6,906 |
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 | (389) | 603 | 1,002 |
receivables | |||
Net (decrease)/ increase in operating liabilities/other | (2,766) | (915) | 347 |
liabilities | |||
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
Share | Share | Merger Reserve | Treasury Shares | ||||||
Based | Based | Translation | |||||||
Share | Share | Payment | Payment | Reserve | Retained | Total | |||
(Unaudited) | Capital | Premium | Reserve | Reserve | Earnings | Equity | |||
(Options) | (Warrants) | ||||||||
$'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 |
- | - | - | - | - | - | 1,697 | (8,617) | (6,920) | |
Total comprehensive income | |||||||||
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
Share | Share | Merger Reserve | Treasury Shares | ||||||
Based | Based | Translation | |||||||
Share | Share | Payment | Payment | Reserve | Retained | Total | |||
(Unaudited) | Capital | Premium | Reserve | Reserve | Earnings | Equity | |||
(Options) | (Warrants) | ||||||||
$'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) |
- | - | - | - | - | - | (3,767) | (4,513) | (8,280) | |
Total comprehensive income | |||||||||
Balance at 30 June 2022 | 102 | 15,596 | 11,453 | 697 | 118,697 | (808) | (3,316) | (112,574) | 29,847 |
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Tiziana Life Sciences Ltd. published this content on 29 December 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 29 December 2023 21:37:55 UTC.
