20-F/A: Tiziana Life Sciences Amends 20-F, Highlights Clinical Program and Corrects Exhibit Numbers

Sentiment:

20-F/A Filing 8 May 2025 5:00 PM

📋All filings for Tiziana Life Sciences LTD

Tiziana Life Sciences files an amendment to its 20-F report to include recent clinical program updates and correct exhibit numbers.

Delay expectedTiziana has recently received a clinical hold letter from the FDA which was primarily focused on amendments to the proposed ALS study trial design, including the addition of a placebo arm.

Capital raiseThe company needs substantial additional funding to complete the development of its product candidates, which may not be available on acceptable terms, if at all.If we are unable to obtain adequate funding on a timely basis, we may be required to significantly curtail, delay or discontinue our R&D programs of our product candidates or any future commercialization efforts, be unable to expand our operations or be unable to otherwise capitalize on our business opportunities, as desired, which could harm our business and potentially cause us to discontinue operations.

Worse than expectedThe company's net losses were $12.0 million, $17.8 million and $15.4 million for the years ended December 31, 2024, 2023 and 2022, respectively.As of December 31, 2024, the company had an accumulated loss of $146 million.

Summary

Tiziana Life Sciences Ltd filed Amendment No. 1 to its annual report on Form 20-F for the fiscal year ended December 31, 2024, to include recent information regarding its clinical program and to correct Exhibit numbers 12.1 and 13.1.
The amendment includes an update in Item 3 Key Information and certifications from the company's principal executive officer and principal financial officer.
The company's net losses were $12.0 million, $17.8 million and $15.4 million for the years ended December 31, 2024, 2023 and 2022, respectively.
As of December 31, 2024, the company had an accumulated loss of $146 million.
The company is focusing on the clinical development of intranasally-administered Foralumab for treatment of neurodegenerative diseases, particularly SPMS.
The company is also continuing development of TZLS-501, a fully human mAb targeting the IL-6 receptor, for treatment of inflammatory and oncology indications, especially SSc-ILD.
The company is seeking orphan drug, fast track or breakthrough designation for its product candidates where warranted.
The company is subject to diverse laws and regulations relating to data privacy and security in the UK and EU, including the EU and UK GDPR.
The company is also subject to the U.K. Bribery Act, the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as export control laws, import and customs laws, trade and economic sanctions laws and other laws governing our operations.

Sentiment

Score: 4

Explanation: The document presents a mixed sentiment. While there are positive developments in the clinical program, the company's financial losses and need for additional funding raise concerns.

Positives

The company is focusing on the clinical development of intranasally-administered Foralumab for treatment of neurodegenerative diseases, particularly SPMS.
The company is also continuing development of TZLS-501, a fully human mAb targeting the IL-6 receptor, for treatment of inflammatory and oncology indications, especially SSc-ILD.
The company is seeking orphan drug, fast track or breakthrough designation for its product candidates where warranted.

Negatives

The company's net losses were $12.0 million, $17.8 million and $15.4 million for the years ended December 31, 2024, 2023 and 2022, respectively.
As of December 31, 2024, the company had an accumulated loss of $146 million.

Risks

The company may fail to demonstrate the safety and therapeutic utility of its product candidates to the satisfaction of applicable regulatory authorities, which would prevent or delay regulatory approval and commercialization.
The company depends on enrollment of patients in its clinical trials for its product candidates and may find it difficult to enroll patients in its clinical trials, which could delay or prevent the company from proceeding with clinical trials.
The company needs substantial additional funding to complete the development of its product candidates, which may not be available on acceptable terms, if at all.
The company relies, and expects to continue to rely, on third parties to conduct its preclinical studies and clinical trials.
The company faces significant competition in an environment of rapid technological change and the possibility that its competitors may achieve regulatory approval before the company or develop therapies that are more advanced or effective than the company's.
The company is subject to governmental regulation and other legal obligations related to privacy, data protection and data security.
The company is subject to the U.K. Bribery Act, the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as export control laws, import and customs laws, trade and economic sanctions laws and other laws governing the company's operations.
The company's relationships with customers, physicians and third-party payors will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws and other healthcare laws and regulations.
The company may not be successful in its efforts to identify or discover additional product candidates and may fail to capitalize on programs or product candidates that may be a greater commercial opportunity or for which there is a greater likelihood of success.
The company's future success depends on its ability to retain key employees, consultants and advisors and to recruit, retain and motivate qualified personnel.
If the company is unable to manage expected growth in the scale and complexity of its operations, its performance may suffer.
The company's employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading, which could have a material adverse impact on its business.
Product liability lawsuits against the company could cause the company to incur substantial liabilities and could limit commercialization of any product candidate that the company may develop.
Geopolitical conflicts, terrorist attacks and international instability could disrupt global markets, supply chains and the company's operations.
The integration of Artificial Intelligence (AI) in the company's operations and products presents regulatory, cyber security, liability and competitive risks that could adversely affect the company's business, financial condition and results of operations.
The company relies on secure communication and information systems and are subject to evolving privacy and data security laws.
The prices of the company's common shares may be volatile and fluctuate substantially, which could result in substantial losses for holders of the company's common shares.
The company's common shares may be delisted from The Nasdaq Capital Market if the company fails to comply with continued listing standards.
Because the company is a foreign corporation, you may not have the same rights as a shareholder in a U.S. corporation.
U.S. persons who own the company's securities may have more difficulty in protecting their interests than U.S. persons who are shareholders of a U.S. corporation.
Certain common shares previously sold under the company's Sales Agreement with respect to its At-the-Market Offering may have been sold in violation of federal and state securities laws and may be subject to rescission rights and other penalties, requiring the company to repurchase shares sold thereunder.
If the company engages in future acquisitions or strategic partnerships, this may increase the company's capital requirements, dilute its shareholders, cause the company to incur debt or assume contingent liabilities and subject the company to other risks.
As an FPI, the company is exempt from a number of rules under the U.S. securities laws and are permitted to file less information with the SEC than U.S. public companies.
As an FPI, the company will file an annual report on Form 20-F within four months of the close of each fiscal year ended December 31 and reports on Form 6-K relating to certain material events promptly after the company publicly announces these events.
The company may lose its FPI status, which would then require the company to comply with the Exchange Acts domestic reporting regime and cause the company to incur significant legal, accounting and other expenses.
If the company fails to establish and maintain proper internal controls, its ability to produce accurate financial statements or comply with applicable regulations could be impaired.
The company's 10% or more stockholders and management own a significant percentage of the company's stock and are able to exercise significant influence over matters subject to stockholder approval.
Claims of U.S. civil liabilities may not be enforceable against the company.
If the company is a passive foreign investment company, there could be adverse U.S. federal income tax consequences to U.S. holders.
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.
Changes and uncertainties in the tax system in the countries in which the company has operations could materially adversely affect the company's financial condition and results of operations, and reduce net returns to its shareholders.

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, seeks regulatory approval, and pursues commercialization of any approved product candidates.

Industry Context

The document highlights Tiziana's focus on developing therapies for neurodegenerative and neuroinflammatory diseases, which aligns with the increasing attention and investment in this therapeutic area within the biotechnology industry.

Comparison to Industry Standards

The document mentions competitors in the biotechnology and pharmaceutical industries, but does not provide specific comparisons to industry standards or benchmarks.
The document does not provide specific comparisons to industry standards or benchmarks.

Related Party Transactions

Rasna Therapeutics Inc is a related party as the entity is controlled by a person that has significant influence over the Group.
OKYO Pharma Ltd is a related party as the entity is controlled by a person that has significant influence over the Group.
Accustem Sciences Inc is a related party as the entity is controlled by a person that has significant influence over the Group.

Stakeholder Impact

Shareholders may experience dilution if the company raises additional capital through equity offerings.
Employees may be affected by potential cost reductions or changes in R&D programs if the company is unable to secure additional funding.
Patients may benefit from the continued development of the company's product candidates, but there is no guarantee of regulatory approval or commercial success.

Next Steps

Continue the clinical development of intranasally-administered Foralumab for treatment of neurodegenerative diseases, particularly SPMS.
Continue development of TZLS-501, a fully human mAb targeting the IL-6 receptor, for treatment of inflammatory and oncology indications, especially SSc-ILD.
Seek orphan drug, fast track or breakthrough designation for product candidates where warranted.

Key Dates

Date	Description
1966	Enactment of the Exempted Undertakings Tax Protection Act in Bermuda.
February 11, 1998	Original incorporation of the company under the laws of England and Wales.
November 29, 2000	Date before which patent applications may remain confidential until patents issue.
March 16, 2013	Effective date of the first-to-file provisions of the Leahy-Smith Act.
May 2013	Inception of Tiziana Life Sciences.
April 2014	Name change to Tiziana Life Sciences plc following the acquisition of Tiziana Pharma Limited.
December 2014	Entry into a license and sublicense agreement with Novimmune for CD3 (NI-0401).
January 2015	Entry into an agreement with Nerviano for Milciclib.
June 9, 2016	Entry into an agreement with Executive Chairman, Gabriele Cerrone.
June 30, 2016	Shareholders approved the Tiziana Life Sciences plc Employee Share Option Plan.
December 2016	Entry into a license and sublicense agreement with Novimmune for IL-6r (NI-1201).
July 2017	Publication of a research article in Clinical Immunology regarding oral treatment with Foralumab.
April 16, 2018	Entry into an exclusive license agreement with The Brigham and Women's Hospital, Inc. for nasal administration of Foralumab.
November 2018	Initiation of a Phase 1 trial with nasally administered Foralumab.
March 2019	Submission of an IND for oral Foralumab.
September 9, 2019	FDA approval to initiate a Phase 1 clinical trial for oral Foralumab.
September 2019	Completion of Phase 1 clinical data demonstrated that nasally administered Foralumab, was well-tolerated and no drug-related safety issues were reported at any of the doses.
December 2019	Completion of Phase 1 clinical trial to evaluate the safety and pharmacokinetics of oral Foralumab.
November 2, 2020	Initiation of a collaborative clinical study investigating nasally administered Foralumab in COVID-19 patients in Brazil.
January 2021	Completion of the clinical trial on nasal administration of Foralumab for treatment of COVID-19.
August 20, 2021	Announcement of a strategic plan to change the corporate structure by establishing Tiziana Life Sciences Ltd, a Bermuda-incorporated company.
October 20, 2021	Effective date of the reorganization, with Tiziana Life Sciences Ltd becoming the ultimate parent company.
January 20, 2022	FDA allowed enrollment of a second EA SPMS patient for treatment with intranasal foralumab.
March 10, 2022	Report of positive clinical data in the first SPMS EA patient following completion of six months of treatment with intranasally administered foralumab.
April 5, 2022	Tiziana announced that FDA granted permission to enroll up to eight additional (SPMS) Intermediate Size Patient Population EAP with intranasal foralumab.
June 2, 2022	Presentation of data from a Secondary Progressive Multiple Sclerosis patient treated with intranasal foralumab at the consortium of multiple sclerosis centers (CMSC) 2022 annual meeting.
June 8, 2022	Announcement of positive clinical results for the second patient (EA2) in the non-active SPMS Expanded Access (EA) Program following three months of dosing with intranasal foralumab.
June 14, 2022	Receipt of a written notice from Nasdaq stating non-compliance with Nasdaq Listing Rule 5550(a)(2).
September 20, 2022	Announcement that the second patient (EA2) with non-active secondary progressive multiple sclerosis (SPMS) receiving intranasal foralumab had shown additional clinical improvements.
October 12, 2022	Announcement of plans to submit an Investigational New Drug Application (IND) for a Phase 1 Trial of intranasal foralumab in Alzheimers disease patients.
November 2, 2022	Announcement of the completion of enrollment of the first patient cohort in its Intermediate Size Patient Population Expanded Access Program to evaluate foralumab in non-active SPMS patients.
November 10, 2022	Announcement of its near-term focus on developing intranasal foralumab for inflammatory diseases of the Central Nervous System (CNS) such as non-active SPMS, Alzheimers disease and amyotrophic lateral sclerosis (ALS).
November 23, 2022	Announcement of publication of a scientific article in the peer-reviewed journal Frontiers in Immunology entitled Nasal administration of anti-CD3 monoclonal antibody modulates effector CD8+ T cell function and induces a regulatory response in T cells in human subjects.
December 13, 2022	Nasdaq notified the company that it was eligible for an additional 180 calendar day period, or until June 12, 2023, to regain compliance.
January 3, 2023	Announcement that the second patient (EA2) with na-SPMS receiving intranasal foralumab exhibited additional clinical improvements since their last reported improvement in September 2022.
January 2023	The IND was withdrawn in January 2023 to refocus clinical activities on use of foralumab for treatment of neurodegenerative diseases.
March 8, 2023	Announcement of a publication in the preeminent journal, Proceedings of the National Academy of Sciences (PNAS), that illustrates the immunological basis of the mechanism of action (MoA) for intranasal foralumab.
March 14, 2023	Tiziana hosted a virtual Key Opinion Leader (KOL) event entitled Foralumab Clinical Update in Multiple Sclerosis; A Landmark Study with Intranasal Immunotherapy.
March 28, 2023	Announcement it has received feedback based on the U.S. Food and Drug Administration (FDA) Type C meeting minutes related to the Phase 2 clinical trial of intranasal foralumab in patients with na-SPMS.
April 4, 2023	Announcement of pre-clinical data on the effects of intranasal anti-CD3 monoclonal antibody in a model of intracerebral hemorrhage (hemorrhagic stroke) demonstrating a behavioral outcome improvement at one month.
April 13, 2023	Announcement of its plans to investigate intranasal foralumab for the treatment of Long COVID.
April 20, 2023	Announcement of its plan to submit an IND for intranasal foralumab in patients with mild to moderate Alzheimers Disease in Q2 2023.
April 21, 2023	Received notice from Nasdaq that it had regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market.
April 23, 2023	Dr. Saef Izzy presented this data from the podium on April 23, 2023 at the Neurocritical Care Scientific Platform Session at the prestigious Annual American Academy of Neurology (AAN) conference in Boston, MA.
June 5, 2023	Announcement of 3-month PET scan results from the first patient cohort in its Intermediate Size Patient Population Expanded Access Program.
July 19, 2023	Received a written notice from Nasdaq notifying us that were not in compliance with the Rule, as the minimum bid price of the Companys common shares has been below $1.00 per share for 30 consecutive business days.
August 15, 2023	Announcement 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.
August 21-24, 2023	Announcement of an oral presentation by Howard Weiner, MD entitled Nasal anti-CD3 mAb induces Tregs that dampen microglial activation and treat neuroinflammatory diseases including MS, AD and ALS at the 16th International Society of Neuroimmunology (ISNI) Congress in Quebec City, Canada.
September 6, 2023	Announcement acceptance of a publication entitled, Nasal Administration of anti-CD3 monoclonal antibody (mAb) ameliorates disease in a mouse model of Alzheimers disease, in the journal, Proceedings of the National Academy of Sciences (PNAS).
September 26, 2023	Announcement initiation of the Phase 2a multicenter clinical trial for treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients with intranasal foralumab.
October 11-13, 2023	Announcement of a late breaking poster entitled, Treatment Of Six Non-Active Secondary Progressive MS With Nasal Anti-CD3 Monoclonal Antibody (Foralumab): Safety, Biomarker, And Disability Outcomes, that was presented at the 39th Congress of the European Committee for Treatment and Research of Multiple Sclerosis (ECTRIMS) held in Milan, Italy.
October 13, 2023	Announcement that a reduction in activated microglia, as seen in six-month Positron Emission Tomography (PET) scans, was observed in a total of five of the six patients with non-active secondary-progressive multiple sclerosis treated with intranasal foralumab in its Expanded Access Program (EAP).
October 16, 2023	Announcement 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 patients participating in an Expanded Access (EA) Program.
October 18, 2023	Announcement that the U.S. Food and Drug Administration (FDA) had allowed multiple sclerosis patients to take home and self-administer Intranasal Foralumab.
November 20, 2023	Announcement that the company had successfully enrolled and dosed four new patients with non-active secondary progressive multiple sclerosis in the Brigham and Womens Hospitals Expanded Access pgrogam.
December 19, 2023	Announcement 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.
January 5, 2024	Announcement the filing of a new patent application relating to composition and methods for combining GLP-1ra and foralumab, a fully human anti-CD3 antibody, to achieve further reductions in systemic and vascular inflammation associated with Type 2 Diabetes (T2D) and also in a separate population of patients with non T2D obesity.
January 8, 2024	Announcement that positive findings had been seen in a total of six out of eight Intermediate Size Patient Population Expanded Access (EA) patients.
January 22, 2024	Nasdaq notified the company that it was eligible for an additional 180 calendar day period, or until July 15, 2024, to regain compliance.
March 13, 2025	Received notice from Nasdaq that it had regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market.
April 18, 2024	Announcement a platform presentation titled, Treatment of PIRA with Nasal Foralumab Dampens Microglial Activation and Stabilizes Clinical Progression in Non-Active Secondary Progressive MS at the Annual Meeting of the American Academy of Neurology in Denver, Colorado.
April 22, 2024	Announcement additional positive clinical results from its intermediate sized Expanded Access Program (EAP) for non-active secondary progressive multiple sclerosis (na-SPMS) patients.
April 23, 2024	Announcement that the U.S. Food and Drug Administration (FDA) had allowed its intranasal foralumab non-active Secondary Progressive Multiple Sclerosis (na-SPMS) Expanded Access (EA) Program to expand from 10 patients to a total of 30 patients.
April 25, 2024	Announcement for the first time, quantitative data showing improvement in White Matter Z-scores measured from PET images taken at 3 months in nasal foralumab treated patients with non-active secondary progressive multiple sclerosis (na-SPMS).
June 6, 2024	Announcement the qualitative results for all 10 non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients enrolled in the intermediate-size patient population Expanded Access (EA) Program receiving foralumab for at least six months.
June 2024	Tiziana announced that the U.S. Food and Drug Administration (FDA) had allowed intranasal foralumab to be used under an Expanded Access (EA) IND in its first patient with moderate Alzheimers disease.
July 24, 2024	Tiziana announced the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for its intranasal formulation of foralumab, a fully human anti-CD3 monoclonal antibody, for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS).
October 30, 2024	Tiziana announced positive results demonstrating the anti-inflammatory potential of our anti-CD3 antibody (foralumab) in combination with semaglutide, a GLP-1 agonist marketed by Novo Nordisk (NYSE: NVO) under the brand names Ozempic and Wegovy.
November 19, 2024	Tiziana announced that its grant application to the ALS Association has been approved for funding.
December 4, 2024	Tiziana announced the expansion of our Phase 2 clinical trial evaluating intranasal foralumab for non-active secondary progressive multiple sclerosis (SPMS).
December 17, 2024	Tiziana announced a significant milestone in our clinical development program for Alzheimers disease. We successfully dosed the first patient with moderate Alzheimers disease using intranasal foralumab at Brigham and Womens Hospital in Boston, Massachusetts following on from their baseline PET scan.
May 8, 2025	Date of certifications by the Principal Executive Officer and Principal Financial Officer.

Keywords

Foralumab, TZLS-501, clinical trials, SPMS, neurodegenerative diseases, financial results, Tiziana Life Sciences, biotechnology, R&D, FDA, regulatory approval, patent, intellectual property, clinical program, financial statements

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