Tiziana foralumab meets both Phase 2a MS trial goals

The presentation lists Phase 2 topline data expected in Q1 2027 for mild Alzheimer's disease and Q2 2027 for multiple system atrophy.

Available on EDGAR 11/09/2026 - 01:35 PM EST Accepted by SEC EDGAR 11/09/2026 - 01:34 PM EST Learn about SEC filing dates

Rhea-AI Filing Summary

Tiziana Life Sciences Ltd reported positive topline results from its placebo-controlled, double-blind Phase 2a INFORM-MS trial of intranasal foralumab in non-active secondary progressive multiple sclerosis. The trial met both primary endpoints, TSPO-PET neuroinflammation and safety.

At 50 μg, TSPO-PET signal was significantly reduced versus placebo (p=0.0168); the exploratory 100 μg arm showed no significant PET change, and the presentation notes fewer patients were enrolled in that arm. The secondary MFIS fatigue measure improved within both active-dose groups from baseline to week 12 (−6.17 at 50 μg; −7.18 at 100 μg), but these were within-arm tests, not treatment-versus-placebo comparisons. All 48 participants completed 12-week treatment, with no study-drug-related serious adverse events reported.

The open-label expanded-access program has dosed 14 patients; the company reports improvement or stability within six months in all. The presentation cautions that open-label, uncontrolled and individual-patient observations do not establish efficacy. Foralumab remains investigational and is not approved for commercial use.

1 point · 1 major

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Positive

• Major pointINFORM-MS met both primary endpoints in its 12-week Phase 2a trial.

Negative

• None.

Filing Explained

The accompanying presentation adds two future clinical milestones: it lists Phase 2 topline data as expected in Q1 2027 for mild Alzheimer’s and Q2 2027 for MSA, making these expected readouts rather than completed results.

Key Figures

INFORM-MS randomized participants: 48 participants TSPO-PET p-value (50 μg vs placebo): 0.0168 MFIS change (50 μg): −6.17 MFIS score change +4 more

7 metrics

INFORM-MS randomized participants 48 participants Placebo-controlled Phase 2a trial

TSPO-PET p-value (50 μg vs placebo) 0.0168 12-week INFORM-MS result; reported reduction in PET signal

MFIS change (50 μg) −6.17 MFIS score change Baseline to week 12; within-arm result

MFIS change (100 μg) −7.18 MFIS score change Baseline to week 12; within-arm result

Expanded-access patients dosed 14 patients Ongoing open-label program

Reduced TSPO-PET signal 8 of 10 patients Expanded-access cohort after three months of treatment

EDSS stabilization 10 of 10 patients Expanded-access cohort after six months of treatment

Key Terms

TSPO-PET, MFIS, EDSS, expanded access program, +2 more

6 terms

TSPO-PET medical

"TSPO-PET Neuroinflammation"

TSPO-PET is a medical imaging technique that uses a radioactive tracer and a PET scanner to highlight the translocator protein (TSPO), a marker that tends to increase where inflammation or immune activity is present in the brain or other tissues. For investors, TSPO-PET matters because it can serve as an objective readout of whether a drug changes disease-related inflammation, like a thermometer showing if a treatment is cooling a fever, and thus can de‑risk clinical development, support regulatory claims, and influence trial enrollment and valuation.

MFIS medical

"Modified Fatigue Impact Scores"

EDSS medical

"EDSS 10 / 10 Patients Stabilized"

EDSS (Expanded Disability Status Scale) is a clinical scale used to quantify disability in people with multiple sclerosis. It runs from 0 (normal neurological exam) to 10 (death from MS) in 0.5-point steps and is based chiefly on neurological examination findings and walking ability; higher scores indicate greater disability. The scale is more sensitive to changes in mobility and ambulation than to cognitive, visual, or fatigue-related impairments, so small score changes do not reflect all kinds of clinical change equally.

expanded access program medical

"open-label intermediate sized Expanded Access (EA) Program"

A program that allows patients with serious or life‑threatening conditions to receive an experimental drug or therapy before it is fully approved by regulators, when they cannot join clinical trials. Investors care because expanded access can change a treatment’s market perception, create early real‑world safety or demand signals, and affect regulatory timelines and potential revenue — like a pre‑order system that also reveals how the product performs outside controlled testing.

progression independent of relapse activity (PIRA) medical

"progression independent of relapse activity (PIRA)"

anti-drug antibodies medical

"No anti-drug antibodies detected in serum"

Anti-drug antibodies are immune system proteins that form in patients in response to a biological therapy, such as a therapeutic protein or antibody, and can bind to the medicine. They matter to investors because they can reduce or eliminate a drug’s effectiveness, create safety problems, force higher dosing or additional testing, and influence regulatory approval and commercial success — like delivery guards accidentally intercepting and stopping a needed package.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did TLSA's Phase 2a INFORM-MS trial find?

Tiziana reported that INFORM-MS met both primary endpoints: TSPO-PET neuroinflammation and safety. In the 50 μg arm, PET signal was significantly reduced versus placebo (p=0.0168); the exploratory 100 μg arm showed no significant PET change. MFIS scores improved within active-dose arms, but the presentation says no treatment-versus-placebo comparison is implied.

How many patients were in the TLSA INFORM-MS trial, and did they complete it?

The study randomized 48 participants: 18 to placebo, 19 to 50 μg foralumab and 11 to 100 μg foralumab. All 48 completed the 12-week treatment period, and no study-drug-related serious adverse events were reported.

What did the foralumab expanded-access program report?

The company said 14 patients had been dosed and all showed improvement or stability within six months. In a 10-patient cohort, 8 of 10 had reduced neuroinflammation on TSPO-PET after three months; 7 of 10 had improved fatigue and 10 of 10 had stabilized EDSS after six months. The presentation cautions that open-label, uncontrolled observations do not establish efficacy.

When are other TLSA foralumab Phase 2 topline results expected?

The presentation lists expected topline data in Q1 2027 for mild Alzheimer's disease and Q2 2027 for multiple system atrophy. It also says the first patients in the ALS Phase 2 study were dosed in September 2026.

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

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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

November 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 November 9, 2026, Tiziana Life Sciences LTD (the “Company”) issued this 6K announcing, additional context on the positive topline results from its Phase 2a INFORM-MS trial, building on the highly engaged Key Opinion Leader (KOL) investor call held on Monday, November 9, 2026. The November 9 call, featuring principal investigator, Tanuja Chitnis, M.D., Tarun Singhal, MBBS, M.D., M.B.A., and Howard L. Weiner, M.D., reviewed the dual primary endpoint success of INFORM-MS and generated strong participation from the investment and scientific communities.

The Announcement and presentation is furnished herewith as Exhibit 99.1 and 99.2 to this Report on Form 6-K. The information in the attached Exhibits 99.1 and 99.2 are 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.

1

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: November 9, 2026	By:	/s/ Keeren Shah
		Name:	Keeren Shah
		Title:	Chief Financial Officer

2

EXHIBIT INDEX

Exhibit No.		Description
99.1		Tiziana Life Sciences LTD Press Release, dated November 9, 2026
99.2		Tiziana Life Sciences LTD Presentation, dated November 9, 2026

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Exhibit 99.1

Tiziana KOL Call Highlights Consistency Between Positive Phase 2a INFORM-MS Topline Results and Longer-Term Clinical Benefits Observed in Expanded Access Program for Patients with Non-Active Secondary Progressive Multiple Sclerosis Treated with Intranasal Foralumab

BOSTON, MA, November 9, 2026 – 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 provided additional context on the positive topline results from its Phase 2a INFORM-MS trial, building on the Key Opinion Leader (KOL) investor call held on Monday, November 9, 2026.

The November 9 call, featuring principal investigator, Tanuja Chitnis, M.D., Tarun Singhal, MBBS, M.D., M.B.A., and Howard L. Weiner, M.D., reviewed the dual primary endpoint success of INFORM-MS with the investment and scientific communities.

Key points emphasized during the discussion included:

● INFORM-MS placebo-controlled 12-week findings confirmed longer-term real-world data trends seen in patients treated for up to 3 years in the foralumab expanded access (EA) program, including EDSS stabilization and improvement in patients with treatment-refractory na-SPMS progressing via PIRA.

● Statistically significant reduction in microglial activation on [¹⁸F]PBR06 TSPO PET imaging with the 50 μg dose versus placebo (p=0.0168)—the dose for which this arm was powered for statistical significance.

● The positive signals in the 50 μg dose (n=19) supporting a potential effect on the chronic neuroinflammation underlying progression independent of relapse activity (PIRA).

● 100 μg dose was exploratory to assess immunomodulatory effects as previous Phase 1 observations showed that higher doses (e.g., 250 μg) had less immunomodulatory effects relative to 50 μg. Fewer patients (n=11) were enrolled in this arm to meet study timelines.

● Favorable safety and tolerability profile of intranasal foralumab as the first non-invasive anti-CD3 therapy at both doses studied.

● Clinically meaningful and statistically significant improvements in Modified Fatigue Impact Scale (MFIS) scores from baseline in both dose arms after only 12 weeks (50 μg: –6.17 points, p=0.035; 100 μg: –7.18 points, p=0.040), an endpoint for which the study was not powered, yet which exceeded the threshold for clinical relevance.

These early signals closely mirror the biological and clinical effects previously observed in the Company’s open-label expanded access program. In the peer-reviewed paper “Nasal Foralumab for the Treatment of Progression Independent of Relapses in Patients With Nonactive Secondary Progressive Multiple Sclerosis” (Chitnis et al., Neurol Neuroimmunol Neuroinflamm 2026;13:e200543), ten patients with treatment-refractory na-SPMS who continued to progress despite B-cell therapy received nasal foralumab for a minimum of six months.

Key findings in the expanded access program included:

● All 10 patients stabilized on Expanded Disability Status Scale (EDSS) scores.

● Three of four patients treated continuously for 12 months demonstrated improvement on EDSS.

● Seven of ten patients showed improvement in fatigue on the MFIS scale after 6 months of foralumab treatment.

● No study drug related serious adverse events have been seen in more than 37.4 patient-years of cumulative exposure.

● Reduction in TSPO-PET signal over six months (p < 0.05), consistent with dampened microglial activation.

● Induction of regulatory immune responses, including increased TGFβ expression across multiple cell subsets.

● No anti-drug antibodies (ADAs) were detected in any serum samples evaluated from patients at multiple time points (baseline through 15–17 months for the longest-treated patients, and through 6 months for others).

Updated data from the ongoing intermediate-size EA program (now encompassing 14 patients, with some treated for up to three years) continues to show favorable tolerability over extended treatment durations, with trends toward disability stabilization and clinically meaningful fatigue improvements, further reinforcing the absence of immunogenicity concerns.

2

“The primary imaging endpoint on TSPO PET in the 50 μg nasal foralumab treatment arm from the INFORM-MS study closely mirrors the reductions in microglial activation we previously published in our expanded access program, providing important corroboration in a placebo-controlled study,” said Tanuja Chitnis, M.D., Principal Investigator of INFORM-MS and Professor of Neurology at Harvard Medical School and Brigham and Women’s Hospital. “Equally encouraging is the clinically significant improvement in fatigue as measured by MFIS, despite the short 12-week treatment duration in the Phase 2 trial. These findings, together with the complete absence of anti-drug antibodies even with prolonged dosing, the longer-duration clinical stabilization and improvement seen in the expanded access patients, underscore the therapeutic potential of nasal foralumab in a population with no FDA-approved therapies specifically indicated for na-SPMS.”

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented: “The industry and scientific community interest in our November 9 KOL call underscores the significance of these data. The consistency between the placebo-controlled 12-week Phase 2a results and the real-world, longer-term experience in our expanded access program strengthens our conviction in intranasal foralumab. Early biological activity on PET and clinically meaningful fatigue improvements after only three months align with the clinical benefits, including EDSS stabilization and improvement, observed with sustained dosing beyond six and twelve months. We look forward to completing the full analysis of the INFORM-MS dataset, discussing next steps with the FDA, and advancing this program for patients who currently have limited options.”

Non-active secondary progressive multiple sclerosis (na-SPMS) is defined by the gradual accumulation of disability independent of clinical relapses or new inflammatory MRI activity—a process known as progression independent of relapse activity (PIRA).

PIRA is now recognized as the predominant driver of long-term disability accumulation across the MS spectrum. In treated relapsing-remitting MS, PIRA accounts for the large majority (approximately 70–90%) of confirmed disability worsening events, even when relapses and new lesions are effectively controlled by high-efficacy disease-modifying therapies. In the progressive phase, PIRA becomes the defining clinical feature.

Unlike relapse-associated worsening, which is driven by focal inflammatory demyelination, PIRA is thought to reflect chronic, compartmentalized (“smoldering”) neuroinflammation within the central nervous system, involving persistent microglial activation, gradual axonal injury, and loss of neural reserve. Current disease-modifying therapies, which primarily target peripheral adaptive immunity and acute inflammatory activity, have shown limited ability to halt or reverse PIRA. As a result, many patients continue to experience irreversible disability progression, worsening fatigue, and functional decline despite optimal control of relapses and MRI activity.

3

There are currently no FDA-approved therapies specifically indicated for na-SPMS or for the treatment of PIRA. This represents one of the most significant remaining unmet needs in multiple sclerosis. Patients with non-active secondary progressive disease have limited therapeutic options once they transition beyond the relapsing phase, and existing agents approved for progressive MS have demonstrated only modest benefits, primarily in patients with residual inflammatory activity.

Tiziana plans to present detailed findings from INFORM-MS at an upcoming scientific meeting and continues to evaluate the broader development path for intranasal foralumab in progressive MS and other neurodegenerative indications.

About Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 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. Intranasal foralumab is also currently being studied in additional Phase 2 trials in AD, ALS, and MSA.

Intranasal 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]

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 intranasal 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 Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.

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

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

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Forward-Looking Statements

Statements in this press release may be “forward-looking statements” within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the 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 forward-looking statements reflect the current beliefs and expectations of Tiziana’s management and statements regarding completion of the INFORM-MS data analysis, presentation of detailed results, engagement with the FDA and potential further clinical development of intranasal foralumab. 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 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, 2025, and other periodic reports filed with the SEC from time to time. The forward-looking statements made in this announcement 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 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

5

Exhibit 99.2

INFORMS-MS A Phase 2 Placebo Controlled, Double Blind Trial of Intranasal Foralumab Non-active Secondary Progressive Multiple Sclerosis (na-SPMS) KOL Call November 9th 2026 Nasdaq: TLSA

2 INFORM-MS KOL Call: Forward-Looking Statements and Important Information Forward-Looking Statements. This presentation may contain forward-looking statements within the meaning of applicable U.S. federal securities laws, including Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These include statements regarding the interpretation and potential implications of INFORM-MS findings, the therapeutic potential of intranasal foralumab, completion and presentation of additional analyses, dose selection, future trial designs, development timelines and planned regulatory discussions. Forward-looking statements reflect current expectations and assumptions, are not guarantees of future performance and involve risks and uncertainties that could cause actual results to differ materially. These include unsuccessful or inconclusive clinical results; differences between preliminary and final analyses; unexpected safety findings; delays in trial initiation, enrollment or completion; regulatory requirements or decisions; inability to obtain sufficient financing; manufacturing and supply constraints; reliance on third parties; intellectual-property risks; and competition. These risks are not exhaustive, and new risks may emerge. The Company cannot predict all risks or assess the impact of every factor, or combination of factors, on its business. Additional risks are described under "Risk Factors" in the Company's most recent Annual Report on Form 20-F and subsequent SEC filings. You should not place undue reliance on forward- looking statements. All forward-looking statements are qualified by these cautionary statements and speak only as of the date of this presentation. Except as required by applicable law, the Company undertakes no obligation to publicly update or revise them, whether as a result of new information, future events or otherwise. Continued availability of this presentation on the Company's website does not mean that its contents remain current. Intranasal foralumab is investigational and is not approved for commercial use. Preliminary, early-stage and expanded-access findings may not predict results in larger or later-stage controlled trials. Any topline findings remain subject to completion of the full analysis. Open-label, uncontrolled and individual-patient observations do not establish efficacy. Cross-trial comparisons are subject to differences in study design, populations, endpoints and follow-up and do not establish comparative safety or efficacy. No assurance can be given that any product candidate will receive regulatory approval. Other Information. Market and industry estimates are subject to assumptions and limitations and do not represent projected Company revenue. This presentation is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities, or investment or medical advice. It should be read together with the Company's SEC filings. Purpose and Speaker Disclosures. This Company-sponsored presentation is for investor information and scientific discussion, not treatment guidance or an offer or solicitation involving securities. Scientific opinions expressed by individual speakers are their own; institutional affiliations do not imply institutional endorsement.

3 INFORM-MS Virtual KOL Call: Meet the Presenters Tanuja Chitnis, M.D. Principal Investigator of the INFORM-MS trial Professor of Neurology, Harvard Medical School / Brigham and Women's Hospital Tarun Singhal, M.B.B.S, M.D., M.B.A. Founding Director, NeuroPET Program Ann Romney Center for Neurologic Diseases, Brigham and Women's Hospital, Mass General Brigham Associate Professor of Neurology, Harvard Medical School Howard L. Weiner, M.D. Chairman of Tiziana's Scientific Advisory Board Robert L. Kroc Professor of Neurology, Harvard Medical School Co-Director, Ann Romney Center for Neurologic Diseases, BWH Ivor Elrifi, Ph.D. Chief Executive Officer & Executive Director Tiziana Life Sciences

4 INFORM-MS: Major Unmet Need in Non-Active SPMS • No FDA-approved therapies specifically indicated for non-active SPMS • Patients with progression independent of relapses (PIRA) remain in need of effective therapy • ~25% of RRMS patients progress to SPMS; substantial portion become non-active • Fatigue is a major symptom impacting quality of life and daily function • Current treatments primarily target active/relapsing disease (e.g., ocrelizumab) • Intranasal foralumab uniquely targets microglial- driven neuroinflammation

CD4+ FoxP3+ Treg Patient inhales the antibody intranasally Binding of foralumab to the T-cell receptor complex in cervical lymph node Tregs are then created and activated These created Tregs then cross the blood brain barrier and regulate the activated innate immune system (microglia). Intranasal Single dose Foralumab Nasal Membrane Uptake BBB Blood-Brain-Barrier Binding T cell CD3/TCR complex 1 2 3 4 Foralumab: Mechanism of Action1,2 1 https://www.pnas.org/doi/10.1073/pnas.2220272120 2 https://www.pnas.org/doi/10.1073/pnas.2309221120

EXPANDED ACCESS TRIAL Intranasal Foralumab Non-active Secondary Progressive Multiple Sclerosis (na-SPMS)

7 Positive Results With Nasal Foralumab in Expanded Access Program No Toxicities No treatment-related toxicities observed No anti-drug antibodies detected in serum TSPO PET 8 / 10 Patients Showed Reduced Neuroinflammation After 3 Months Treatment Fatigue 7 / 10 Patients Improved After 6 Months Treatment EDSS 10 / 10 Patients Stabilized After 6 Months Treatment 3 / 4 Patients Improved After 12 Months Treatment Neurol Neuroimmunol Neuroinflamm 2026;13:e200543. doi:10.1212/NXI.0000000000200543

8 Nasal Foralumab Reduced Neuroinflammation in Expanded Access Program Neurol Neuroimmunol Neuroinflamm 2026;13:e200543. doi:10.1212/NXI.0000000000200543 Reduced TSPO-PET signal after nasal foralumab treatment. Individualized pGALP z-score maps for patients EA6 (A) and EA1 (B) superimposed on respective patient's T1-weighted MRI demonstrate decreased PET signal after treatment at 3 months (middle row) and 6 months (bottom row) as compared with baseline (top row). Hotter colors represent a higher z-score value and cooler colors represent a lower z-score value as determined by the GALP 2.0 pipeline. (C and D) White matter and global PET scores at baseline and on treatment. Decreased voxel-wise average [F-18] PBR06-PET mGALP z-scores (GALP 3.0) in white matter (C) and global (D) regions of interest after nasal foralumab treatment for 3 months and 7.5 months (mean duration of treatment at last available PET follow-up visit). GALP = Glial activity load on PET.

9 Nasal Foralumab Modulates Immune Function Molecular & Cellular Effects in Blood & CSF of na-SPMS Patients Treated with Nasal Foralumab Results after 6 months nasal foralumab treatment Increase in regulatory T cells (Tregs) Decrease in cytotoxic T cells Reduced inflammation in spinal fluid

INFORMS-MS TOPLINE DATA Phase 2 Placebo Controlled, Double Blind Trial of Intranasal Foralumab Confirms Results of EA Program Non-active Secondary Progressive Multiple Sclerosis (na-SPMS)

11 INFORM-MS: Participant Flow and Evaluable Data 67 screened 48 randomized Placebo 18 randomized Safety 18 of 18 PET scan pair 15 of 18 MFIS total 17 of 18 EDSS 18 of 18 Foralumab 50 µg 19 randomized Safety 19 of 19 PET scan pair 15 of 19 MFIS total 18 of 19 EDSS 18 of 19 Foralumab 100 µg 11 randomized Safety 11 of 11 PET scan pair 10 of 11 MFIS total 11 of 11 EDSS 11 of 11 All participants (48) Safety 48 · PET scan pair 40 · MFIS total 46 · EDSS 47

12 INFORM-MS: Topline Results Overview Both primary endpoints (TSPO-PET Neuroinflammation and safety) were met. Secondary MFIS endpoint also met. PET Microglial Activation 50 μg vs Placebo p = 0.0168 Statistically significant reduction in TSPO-PET signal demonstrating decreased microglial activation. In an exploratory dose arm (100 μg) no significant change in PET signal. Fewer patients enrolled in this arm. Prior data with 250 μg also showed less immunomodulatory effects than the 50 μg dose. FATIGUE (MFIS) Clinically Meaningful Change from baseline → Week 12 –6.17 / –7.18 50 μg (p=0.035) · 100 μg (p=0.040) Within-arm paired improvements at both doses. Fatigue is a key driver of quality of life in progressive MS. SAFETY Clean Profile Both doses No Drug Related SAEs The first non-invasive anti-CD3 therapy shown to be safe and well tolerated No study-drug related serious adverse events. All 48 participants completed treatment No discontinuations due to AEs. All 48 participants completed the 12-week treatment period · Both doses safe and well-tolerated · Supports advancement toward registrational path

13 INFORM-MS: Neuroinflammation Was Statistically Significantly Reduced On ANCOVA analysis, [¹⁸F]PBR06-TSPO PET demonstrated a significant reduction in globally normalized White Matter SUVR (p=0.0168) after 12 weeks of treatment between the 50 ug nasal foralumab treatment arm and placebo. Examples of individualized patient mGALP z-score maps following treatment with 50mcg of nasal foralumab and with placebo

14 INFORM-MS: Nasal Foralumab Reduced Fatigue (Lowered Modified Fatigue Impact Scores; "MFIS") MFIS: * p < 0.05 is a within-arm paired t-test; no treatment-versus-placebo comparison is implied (n = 18, 11, 17 with a complete pair). https://www.msard-journal.com/article/S2211-0348(19)30319-0/fulltext Rooney et al. 2019 MFIS total score, baseline to Week 12

15 INFORM-MS: Topline Results Overview Both primary endpoints (TSPO-PET Neuroinflammation and safety) were met. Secondary MFIS endpoint also met. PET Microglial Activation 50 μg vs Placebo p = 0.0168 Statistically significant reduction in TSPO-PET signal demonstrating decreased microglial activation. In an exploratory dose arm (100 μg) no significant change in PET signal. Fewer patients enrolled in this arm. Prior data with 250 μg also showed less immunomodulatory effects than the 50 μg dose. FATIGUE (MFIS) Clinically Meaningful Change from baseline → Week 12 –6.17 / –7.18 50 μg (p=0.035) · 100 μg (p=0.040) Within-arm paired improvements at both doses. Fatigue is a key driver of quality of life in progressive MS. SAFETY Clean Profile Both doses No Drug Related SAEs The first non-invasive anti-CD3 therapy shown to be safe and well tolerated No study-drug related serious adverse events. All 48 participants completed treatment No discontinuations due to AEs. All 48 participants completed the 12-week treatment period · Both doses safe and well-tolerated · Supports advancement toward registrational path

16 Intranasal Foralumab Pipeline Nasdaq: TLSA Preclinical IND Phase 1 Expanded Access Program Phase 2 Phase 3 Non-Active Secondary Progressive Multiple Sclerosis Phase 2 Study Positive Topline Data November 2026 Multiple System Atrophy (MSA) Phase 2 Study Expecting Topline Data Q2 2027 Alzheimer's Disease (Mild) Phase 2 Study Expecting Topline Data Q1 2027 ALS Phase 2 Study First Patients Dosed Sept 2026 Non-Active Secondary Progressive Multiple Sclerosis (EA Program) Ongoing Expanded Access Program Moderate Alzheimer's Disease (EA Program) Ongoing Expanded Access Program

17 Nasal foralumab dampens microglial activation in Alzheimer's Disease Singhal T, Cicero S, Gale SA, Horan N, Dubey S, Marshall GA, Weiner HL. Dampening of Microglial Activation With Nasal Foralumab Administration in Moderate Alzheimer's Disease Dementia Clin Nucl Med. 2025 Aug 1;50(8):756-757

18 Nasal foralumab reduces microglial activation in Multiple System Atrophy Tiziana LifeSciences press releases Marked reduction in basal ganglia uptake following nasal foralumab PRE FORALUMAB POST FORALUMAB PRE FORALUMAB POST FORALUMAB Marked reduction in Cerebellar white matter uptake following nasal foralumab

Questions Nasdaq: TLSA

US Headquarters (Boston) Tiziana Life Sciences Ltd. 535 Boylston Street, Floor 8 Boston, MA 02116 UK Headquarters (London) Tiziana Life Sciences plc 35a Albemarle Street London W1S 4JE Investors: +44 (0)207 495 2379 info@tizianalifesciences.com Nasdaq: TLSA

Filing Exhibits & Attachments

2 documents

Press Releases

• EX-99.1 TIZIANA LIFE SCIENCES LTD PRESS RELEASE, DATED NOVEMBER 9, 2026 35.6 KB
• EX-99.2 TIZIANA LIFE SCIENCES LTD PRESENTATION, DATED NOVEMBER 9, 2026 24.1 KB