20-F: Tiziana Life Sciences Reports Full Year 2023 Results and Provides Business Update

Sentiment:

Annual Report 10 May 2024 5:00 PM

📋All filings for Tiziana Life Sciences LTD

Tiziana Life Sciences Ltd reports its financial results for the year ended December 31, 2023, and provides an update on its clinical development programs, focusing on intranasal foralumab for neurodegenerative diseases.

Capital raiseThe company states that it will need to continue to rely on additional financing to achieve its business objectives.The company states that adequate additional financing may not be available to it on acceptable terms, if at all.The company states that if it is unable to obtain adequate funding on a timely basis, it may be required to significantly curtail, delay or discontinue its R&D programs of its product candidates or any future commercialization efforts.

Worse than expectedThe company's net losses increased from $15.4 million in 2022 to $17.8 million in 2023.The company's cash and cash equivalents decreased from $18.1 million in 2022 to $1.2 million in 2023.

Summary

Tiziana Life Sciences Ltd, a biotechnology company, reported its financial results for the year ended December 31, 2023.
The company is focused on developing therapies for neurodegenerative and lung diseases, with a clinical pipeline including drug assets for Secondary Progressive Multiple Sclerosis (SPMS), ALS, and Alzheimers.
A key focus is the development of intranasal foralumab for treatment of neurodegenerative diseases, especially SPMS.
The company incurred net losses of $17.8 million in 2023, $15.4 million in 2022, and $23.4 million in 2021.
As of December 31, 2023, the company had cash and cash equivalents of $1.2 million.
Research and development expenses were $8.1 million in 2023, compared to $12.9 million in 2022.
The company is planning a Phase 2 trial for intranasal foralumab in SPMS patients and has received FDA clearance for an IND for intranasal foralumab in Alzheimers disease.
The company is also investigating intranasal foralumab for the treatment of Long COVID.
The company has completed a 26 week toxicology study for intranasal foralumab on February 15, 2024.
The company has a material weakness in internal control over financial reporting related to the timely development and communication of an employee handbook.

Sentiment

Score: 5

Explanation: The document presents a mixed picture. While there are positive clinical developments, the company's financial situation is concerning, and there are significant risks associated with its business operations. The sentiment is neutral as the positive clinical developments are offset by the negative financial results and risks.

Positives

Positive clinical data from an Expanded Access program in SPMS patients treated with intranasal foralumab.
FDA clearance of the IND application for intranasal foralumab to be studied in Alzheimers disease.
Initiation of a Phase 2a multicenter clinical trial for treatment of non-active SPMS patients with intranasal foralumab.
Completion of a 26 week toxicology study for intranasal foralumab on February 15, 2024.

Negatives

The company incurred net losses of $17.8 million in 2023, $15.4 million in 2022, and $23.4 million in 2021.
As of December 31, 2023, the company had cash and cash equivalents of $1.2 million.
The company has a material weakness in internal control over financial reporting related to the timely development and communication of an employee handbook.

Risks

The company's limited cash resources raise concerns about its ability to continue as a going concern.
The success of clinical trials is uncertain, and delays or failures could negatively impact the company's prospects.
The company faces competition from other pharmaceutical and biotechnology companies.
Regulatory approvals are not guaranteed and may be delayed or denied.
The company relies on third parties for manufacturing and clinical trials, which could lead to delays or disruptions.
The company's intellectual property rights may be challenged or infringed.
The company is subject to various government regulations, including those related to privacy, data protection, and anti-corruption.
The company may face product liability lawsuits.
The company's common shares may be delisted from The Nasdaq Capital Market if it fails to comply with continued listing standards.
The company may be unable to use net operating loss and tax credit carryforwards and certain built-in losses to reduce future tax payments or benefit from favorable U.K. tax legislation.

Future Outlook

The company expects to continue to incur significant expenses for the foreseeable future as it advances its product candidates through preclinical and clinical development and seeks regulatory approval and pursues commercialization of any approved product candidates.

Industry Context

The biotechnology and pharmaceutical industries are characterized by rapid technological change, significant competition, and a strong emphasis on intellectual property. Tiziana faces competition from many different sources, including large and specialty pharmaceutical and biotechnology companies, academic research institutions, government agencies and public and private research institutions.

Comparison to Industry Standards

The report mentions FDA-approved drugs like TYSABRI, MAYZENT, and ZEPOSIA, which suppress microglial activation and exert neuroprotective effects in the central nervous system (CNS) in animal studies, but lack longitudinal assessment of drug effects on microglial activation in exclusive cohorts of SPMS patients.
This highlights a potential competitive advantage for Tiziana's foralumab if it can demonstrate sustained clinical benefits and microglial activation reduction in SPMS patients.
The report also mentions teplizumab (Provention Bio), a humanized Fc-mutated anti-CD3 monoclonal antibody, as a competitor in the Type 1 Diabetes (T1D) space.
Tiziana believes that Foralumab, a fully human anti-CD3 mAb, would have a better safety profile and clinical benefit than Teplizumab based on Foralumabs fully human protein sequence and binding affinity for CD3e compared to Teplizumab.

Corporate Governance

Change Type	Description	Effective Date	Impact Assessment
Internal Control	The company did not maintain an effective control environment due to the lack of a timely developed and communicated employee handbook.	December 31, 2023	This material weakness could result in a material misstatement of the company's annual or interim consolidated financial statements.

Related Party Transactions

The company has entered into shared services agreements with Rasna Therapeutics Inc and OKYO Pharma Ltd, entities controlled by a person with significant influence over the Group.
The company has an investment in Accustem Sciences Inc, a related party, and recognized a fair value loss on this investment.
The company acquired 2.1m shares of Okyo Pharma Ltd. on October 23, 2023 which is a 15.57% ownership.

Stakeholder Impact

Shareholders face the risk of dilution if the company raises additional capital through equity offerings.
Employees may be affected by potential cost-cutting measures or changes in R&D programs.
Patients with neurodegenerative and lung diseases could benefit from successful development and commercialization of the company's product candidates.
Suppliers and creditors may be impacted by the company's financial condition and ability to meet its obligations.

Next Steps

Continue the Phase 2a multicenter clinical trial for treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients with intranasal foralumab.
Investigate intranasal foralumab for the treatment of Long COVID.
Submit an IND for intranasal foralumab in patients with mild to moderate Alzheimers Disease in Q2 2023.
Continue to supply foralumab for intranasal treatment of up to 10 EA patients at Brigham and Womens Hospital.

Key Dates

Date	Description
February 11, 1998	Original incorporation of the company in England and Wales.
December 2014	Tiziana entered into a license and sublicense agreement with Novimmune for Foralumab.
January 2015	Tiziana entered into an agreement with Nerviano for Milciclib.
January 2017	Tiziana licensed the intellectual property for TZLS-501 from Novimmune.
April 16, 2018	Tiziana entered into an exclusive license agreement with The Brigham and Womens Hospital, Inc. relating to a novel formulation of Foralumab dosed in a medical device for nasal administration.
September 9, 2019	The FDA granted approval to initiate the Phase 1 clinical trials to evaluate the safety and pharmacokinetics of a novel enteric-coated capsule formulation of oral Foralumab.
August 18, 2020	The USPTO granted Tiziana a patent on use and methods of treatment of Crohns disease with Foralumab.
October 20, 2021	Tiziana Life Sciences Ltd, a Bermuda-incorporated company, became the ultimate parent company of the Tiziana Group.
May 25, 2021	The first expanded access (EA) patient with secondary progressive multiple sclerosis (SPMS) was dosed with nasally administered Foralumab at the Brigham and Womens Hospital (BWH), Harvard Medical School, Boston, MA.
March 10, 2022	Tiziana reported positive clinical data in the first EA SPMS patient following completion of six months of treatment with intranasally administered foralumab, at the Brigham and Womens Hospital (BWH), Harvard University, Boston, MA.
August 15, 2023	Tiziana announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for intranasal foralumab to be studied in Alzheimers disease.
September 26, 2023	Tiziana announced initiation of the Phase 2a multicenter clinical trial for treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients with intranasal foralumab.
December 19, 2023	Tiziana announced first patient dosed in its Phase 2a study comparing two doses of intranasal foralumab and placebo in patients with non-active secondary-progressive multiple sclerosis.
February 15, 2024	The 26 week toxicology study was completed.

Keywords

Foralumab, Milciclib, SPMS, Alzheimers, ALS, Neurodegenerative diseases, Clinical trials, Biotechnology, Pharmaceutical, Immunology

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