Tiziana: 50-microgram foralumab meets MS trial goals
Tiziana intends to complete the data analysis, present detailed results at a scientific congress and engage the FDA on next clinical steps.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Tiziana Life Sciences Ltd (TLSA) announced it will host a conference call and webcast on November 9, 2026, to discuss topline results from its Phase 2a INFORM-MS trial of intranasal foralumab in non-active secondary progressive multiple sclerosis.
The 50 μg arm met the trial’s dual primary endpoints of safety/tolerability and reduction in microglial activation on TSPO PET imaging. MFIS Total Score changes were -6.17 points in the 50 μg arm and -7.18 points in the 100 μg arm, statistically significant versus each arm’s baseline; the placebo change was -3.12 points and was not significant. All 48 participants completed 12 weeks of treatment, with no study-drug-related serious adverse events reported.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Major point50 μg arm met both Phase 2a primary endpoints.
Negative
- None.
Filing Explained
Tiziana says it intends to complete the full trial-data analysis, present detailed results at a future scientific congress, and engage the FDA on next steps for foralumab in na-SPMS; these are plans, not completed milestones.
Key Figures
Key Terms
TSPO PET imaging medical
MFIS Total Score medical
microglial activation medical
Expanded Access (EA) Program medical
anti-CD3 monoclonal antibody medical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were the TLSA INFORM-MS fatigue results?
Did the TLSA INFORM-MS trial meet its primary endpoints?
When is the TLSA INFORM-MS investor call?
AI-generated analysis. How Rhea-AI works. Not financial advice.
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)
9th 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 ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On November 5, 2026, Tiziana Life Sciences LTD (the “Company”) issued this 6K announcing, that it will host a conference call and webcast with Key Opinion Leaders (KOLs) to discuss the positive topline results from its Phase 2a INFORM-MS trial of intranasal foralumab in non-active secondary progressive multiple sclerosis (na-SPMS). In this multi-center, randomized, double-blind, placebo-controlled Phase 2a trial, the 50μg dose of nasal foralumab delivered a clear and statistically significant immunomodulatory effect, producing a meaningful reduction in neuroinflammation as measured by TSPO PET imaging. Despite the short treatment duration of only 12 weeks, patients in both foralumab dose arms experienced clinically significant and statistically significant improvements in fatigue, a common and debilitating symptom of progressive MS. This exceeded the established threshold for clinical relevance and with greater improvements than placebo. These compelling dual outcomes in a population with no FDA-approved disease-modifying therapies represent a major step forward and support advancement to a pivotal trial.
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. This report on Form 6-K is hereby incorporated by reference into the Company’s Registration Statement on Form F-3 (Reg. No. 333-286064) and Form S-8 (Reg. No. 333-293620).
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 5, 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 5, 2026 |
3
Exhibit 99.1
Tiziana to Host Investor Call with Key Opinion Leaders to Discuss Positive Phase 2a INFORM-MS Topline Results
| ● | Trial met primary endpoint with a statistically significant reduction in microglial activation on TSPO PET (p=0.0168) |
| ● | Intranasal foralumab is the first non-invasive anti-CD3 therapy that has shown a favorable safety and tolerability profile at both doses studied |
| ● | Clinically meaningful and statistically significant fatigue improvements in both dose arms after only 12 weeks underscore the strong therapeutic potential of nasal foralumab in a population with no FDA-approved therapies for na-SPMS |
BOSTON, MA, November 5, 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 announced that it will host a conference call and webcast with Key Opinion Leaders (KOLs) to discuss the positive topline results from its Phase 2a INFORM-MS trial of intranasal foralumab in non-active secondary progressive multiple sclerosis (na-SPMS).
In this multi-center, randomized, double-blind, placebo-controlled Phase 2a trial, the 50μg dose of nasal foralumab delivered a clear and statistically significant immunomodulatory effect, producing a meaningful reduction in neuroinflammation as measured by TSPO PET imaging. Despite the short treatment duration of only 12 weeks, patients in both foralumab dose arms experienced clinically significant and statistically significant improvements in fatigue, a common and debilitating symptom of progressive MS. This exceeded the established threshold for clinical relevance and with greater improvements than placebo. These compelling dual outcomes in a population with no FDA-approved disease-modifying therapies represent a major step forward and support advancement to a pivotal trial.
The call will feature:
| ● | Tanuja Chitnis, M.D., Principal Investigator of the INFORM-MS trial and Professor of Neurology at Harvard Medical School / Brigham and Women’s Hospital |
| ● | Tarun Singhal, MBBS, M.D., M.B.A., Founding Director, NeuroPET Program, Ann Romney Center for Neurologic Diseases, Brigham and Women’s Hospital, Mass General Brigham, and Associate Professor of Neurology at Harvard Medical School |
| ● | Howard L. Weiner, M.D., Chairman of Tiziana’s Scientific Advisory Board, Robert L. Kroc Professor of Neurology at Harvard Medical School, Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, and whose laboratory discoveries form the scientific foundation for the development of intranasal foralumab |
Drs. Chitnis, Singhal and Weiner will review the trial’s dual primary endpoint results and secondary clinical findings. Key topics will include:
| ● | The primary endpoint reaching a statistically significant reduction in microglial activation measured by [¹⁸F]PBR06 TSPO PET imaging in the 50 μg nasal foralumab arm versus placebo (p=0.0168), the dose for which we enrolled a sufficient number of patients for this study to be powered for statistical significance |
| ● | Interpretation of the observed variance in PET outcomes between the 50 μg dose and the exploratory 100 μg dose (our previous Phase 1 study demonstrated that 250 μg had minimal immunomodulatory effects compared to the 50 μg dose) |
| ● | Clinically meaningful and statistically significant improvements in Modified Fatigue Impact Scale (MFIS) scores from baseline in both foralumab treatment arms after only 12 weeks of therapy, an endpoint for which this study was not powered for statistical significance |
| ● | The overall favorable safety and tolerability profile across both doses |
In the INFORM-MS trial, foralumab-treated subjects showed statistically significant improvements in MFIS Total Score compared with their own baseline: a –6.17 point decrease in the 50 μg arm (p=0.035) and a –7.18 point decrease in the 100 μg arm (p=0.040). No significant change was observed in the placebo group (–3.12 points). These reductions exceed the threshold for clinical significance and align with previously reported findings from the Company’s expanded access program in na-SPMS, in which patients have been dosed with foralumab for up to three years.
Conference Call Details
Date: November 9th 2026
Time: 12:00pm ET / 17:00pm GMT
Webcast link: https://edge.media-server.com/mmc/p/7ox8odig
A replay of the call will be available on the Investors section of the Company’s website following the live event.
“Following our strong Phase 2 results, we are pleased to provide the investor and scientific community with the opportunity to hear directly from the leading investigators who guided INFORM-MS,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. “Drs. Chitnis, Singhal and Weiner will offer important perspectives on the PET imaging results, including the differences observed across dose groups, as well as the clinically significant MFIS improvements seen at both dose levels. These data further support the biological and clinical activity of intranasal foralumab in a patient population with significant unmet need.”
2
As previously announced, the randomized, double-blind, placebo-controlled INFORM-MS trial met its dual primary endpoints of safety/tolerability and reduction in microglial activation on TSPO PET imaging in the 50 μg arm. Both the 50 μg and 100 μg doses were well tolerated, with all 48 participants completing treatment and no study-drug related serious adverse events reported.
Tiziana intends to complete the full analysis of the INFORM-MS data set, present detailed results at an upcoming scientific congress, and engage with the U.S. Food and Drug Administration regarding next steps in the clinical development of intranasal foralumab for na-SPMS.
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 |
3
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
4