Tiziana Life Sciences (TLSA) highlights Phase 2a intranasal foralumab MSA trial at World Parkinson Congress

(Neutral)

Form Type

6-K

Rhea-AI Filing Summary

Tiziana Life Sciences Ltd has reported that a late-breaking poster on its Phase 2a study of intranasal foralumab in Multiple System Atrophy (MSA) has been accepted for presentation at the 7th World Parkinson Congress in Phoenix, Arizona, taking place May 24-27, 2026.

The poster will describe the ongoing TILS-025 trial, the first clinical investigation of intranasal anti-CD3 therapy in MSA, an aggressive neurodegenerative disorder with no approved disease-modifying treatments. The open-label study enrolls up to 10 subjects aged 30–85 who receive intranasal foralumab 50 μg per dose for 6 months.

Key measures include changes in microglial activation via [F-18]PBR06 TSPO PET imaging and MDS-UMSARS scores, along with MRI-based brain atrophy, autonomic function, quality-of-life outcomes, and blood and CSF immune biomarkers. The company also highlights ongoing intranasal foralumab programs in non-active secondary progressive multiple sclerosis and prior evidence of reduced neuroinflammation in other neurological conditions.

Key Figures

Congress dates: May 24-27, 2026 TILS-025 enrollment: Up to 10 subjects Foralumab dose: 50 μg per dose +3 more

6 metrics

Congress dates May 24-27, 2026 7th World Parkinson Congress presentation window

TILS-025 enrollment Up to 10 subjects Phase 2a open-label MSA trial size

Foralumab dose 50 μg per dose Intranasal dosing regimen for six months in TILS-025

Treatment duration 6 months Intranasal foralumab treatment period in TILS-025

Expanded access patients 14 patients Non-active secondary progressive multiple sclerosis EA program

Age range 30–85 years Eligibility criteria for MSA subjects in TILS-025

Key Terms

Multiple System Atrophy, intranasal foralumab, TSPO PET imaging, MDS-UMSARS scores, +2 more

6 terms

Multiple System Atrophy medical

"Multiple System Atrophy is a rapidly progressive neurodegenerative disorder characterized by autonomic dysfunction, parkinsonism, and cerebellar impairment"

A progressive neurological disorder that damages multiple areas of the nervous system, causing problems with movement, balance and involuntary functions like blood pressure and bladder control; think of it as critical wiring in the body slowly failing. Investors care because the condition defines the size and urgency of the market for treatments, influences clinical trial difficulty and regulatory risk, and can lead to high per-patient pricing but also greater development uncertainty.

intranasal foralumab medical

"a Phase 2a study of intranasal foralumab in Multiple System Atrophy"

Intranasal foralumab is an experimental antibody medication given as a spray or drops into the nose that aims to change how the immune system behaves rather than attack a virus directly. Investors care because results from trials, safety findings, and regulatory decisions determine whether this approach can become a marketed therapy, affecting a company’s future sales, development costs and competitive position — similar to betting on a new product that could reshape a company’s revenue stream.

TSPO PET imaging medical

"Primary endpoints include changes in microglial activation measured by [F-18]PBR06 TSPO PET imaging"

MDS-UMSARS scores medical

"Primary endpoints include changes in microglial activation ... and changes in MDS-UMSARS scores"

Expanded Access (EA) Program regulatory

"have been dosed in an open-label intermediate sized Expanded Access (EA) Program"

monoclonal antibody medical

"intranasal foralumab, a fully human, anti-CD3 monoclonal antibody"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Form 6-K: How Foreign Companies Report to the SEC →

Accepted by SEC EDGAR 04/14/2026 - 07:00 AM

FAQ

What did Tiziana Life Sciences (TLSA) announce in this Form 6-K?

Tiziana Life Sciences announced that a late-breaking poster on its Phase 2a intranasal foralumab study in Multiple System Atrophy was accepted for presentation at the 7th World Parkinson Congress in Phoenix, highlighting the design and rationale of its ongoing TILS-025 clinical trial.

What is the TILS-025 Phase 2a trial of intranasal foralumab in MSA?

TILS-025 is an open-label Phase 2a trial evaluating intranasal foralumab in up to 10 patients with clinically established or probable Multiple System Atrophy. Participants receive 50 μg intranasal doses for six months, with primary endpoints focused on microglial activation and MDS-UMSARS clinical scores.

What are the primary and secondary endpoints in Tiziana’s MSA study?

Primary endpoints include changes in microglial activation measured by [F-18]PBR06 TSPO PET imaging and changes in MDS-UMSARS scores. Secondary endpoints cover regional brain atrophy on volumetric MRI, autonomic function, quality-of-life measures, and immune biomarkers in blood and cerebrospinal fluid.

How has intranasal foralumab performed in other Tiziana Life Sciences studies?

Intranasal foralumab has previously shown reduction of neuroinflammation in clinical studies for multiple sclerosis and Alzheimer’s disease. In an expanded access program, 14 non-active secondary progressive multiple sclerosis patients showed either improvement or stability of disease within six months after treatment.

What other trials of intranasal foralumab is Tiziana Life Sciences running?

Tiziana is also conducting a Phase 2a randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial of intranasal foralumab in patients with non-active secondary progressive multiple sclerosis, in addition to the open-label expanded access program that has dosed 14 such patients so far.

Why is Multiple System Atrophy a key focus for Tiziana Life Sciences (TLSA)?

Multiple System Atrophy is a rapidly progressive neurodegenerative disorder with autonomic dysfunction, parkinsonism, and cerebellar impairment, and no approved disease-modifying therapies. Tiziana is targeting neuroinflammation and microglial activation with intranasal foralumab as a potential new treatment approach.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

April 2026

Commission File Number: 001-38723

Tiziana Life Sciences LTD

(Exact Name of Registrant as Specified in Its Charter)

9^th Floor

107 Cheapside

London

EC2V 6DN

(Address of registrant’s principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

On April 14, 2026, Tiziana Life Sciences LTD (the “Company”) issued this 6K announcing, that a late-breaking poster on its Phase 2a study of intranasal foralumab in Multiple System Atrophy (MSA) has been accepted for presentation at the 7th World Parkinson Congress, taking place May 24-27, 2026, in Phoenix, Arizona.

The Announcement is furnished herewith as Exhibit 99.1 to this Report on Form 6-K. The information in the attached Exhibits 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	TIZIANA LIFE SCIENCES LTD

Date: April 14, 2026	By:	/s/ Keeren Shah
		Name:	Keeren Shah
		Title:	Chief Financial Officer

EXHIBIT INDEX

Exhibit No.		Description

99.1		Tiziana Life Sciences LTD Press Release, dated April 14, 2026

Exhibit 99.1

Tiziana Life Sciences Announces Late Breaking Poster Accepted for Presentation at the 7^th World Parkinson Congress

BOSTON, MA, April 14, 2026 – Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana”), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces that a late-breaking poster on its Phase 2a study of intranasal foralumab in Multiple System Atrophy (MSA) has been accepted for presentation at the 7th World Parkinson Congress, taking place May 24-27, 2026, in Phoenix, Arizona.

The poster, titled “A Phase 2a Study of Intranasal Foralumab in Multiple System Atrophy,” will highlight the design and rationale of the ongoing TILS-025 trial (NCT06868628), the first clinical investigation of intranasal anti-CD3 therapy in MSA.

Multiple System Atrophy is a rapidly progressive neurodegenerative disorder characterized by autonomic dysfunction, parkinsonism, and cerebellar impairment, with no approved disease-modifying therapies. Neuroinflammation and microglial activation are recognized as key drivers of disease progression. Foralumab, delivered intranasally, has previously shown a reduction of neuroinflammation in clinical study’s for multiple sclerosis and Alzheimer’s disease. The TILS-025 study evaluates its potential to attenuate microglial activation in MSA.

This Phase 2a, open-label trial is enrolling up to 10 subjects with clinically established or clinically probable MSA (per 2022 MDS criteria), ages 30–85, in collaboration with the Mass General Brigham MyTrial-MSA and Harvard Biomarkers Study 2.0 programs. Participants receive intranasal foralumab (50 μg per dose) for 6 months, with pre-treatment observational data collected where available. Primary endpoints include changes in microglial activation measured by [F-18]PBR06 TSPO PET imaging and changes in MDS-UMSARS scores. Secondary endpoints encompass regional brain atrophy on volumetric MRI, autonomic function, quality-of-life measures, and immune biomarkers in blood and CSF.

“We are thrilled that our Phase 2a study of intranasal foralumab in Multiple System Atrophy has been selected as a late-breaking poster at the 7th World Parkinson Congress,” said Ivor Elrifi, CEO of Tiziana Life Sciences. “This acceptance underscores the growing interest in foralumab’s novel intranasal approach to modulating neuroinflammation. MSA is a devastating disease with high unmet need, and we believe foralumab’s ability to target microglial activation could represent a meaningful step forward for patients. We look forward to sharing updates from this important trial with the global Parkinson’s and MSA community in Phoenix.”

About Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biologic candidate that has been shown to stimulate T regulatory cells when dosed intranasally. Currently, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).

Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.^[1],[2],[3]

[1]	https://www.pnas.org/doi/10.1073/pnas.2220272120

[2]	https://www.pnas.org/doi/10.1073/pnas.2309221120

[3]	https://www.neurology.org/doi/10.1212/NXI.0000000000200543

About Tiziana Life Sciences

Tiziana 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 currently in clinical development, 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 more information about Tiziana and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Tiziana'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 Tiziana's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. Tiziana cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of Tiziana only as of the date of this announcement. 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 announcement relate only to events as of the date on which the statements are made. Tiziana 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 announcement except as required by law or by any appropriate regulatory authority.

For further inquiries:

Tiziana Life Sciences Ltd

Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

1 document

Press Releases

EX-99.1 TIZIANA LIFE SCIENCES LTD PRESS RELEASE, DATED APRIL 14, 2026 11.6 KB