Intranasal foralumab shows SPMS safety and fatigue gains at Tiziana (Nasdaq: TLSA)
Rhea-AI Filing Summary
Tiziana Life Sciences reported updated clinical data from its Expanded Access program testing intranasal foralumab in 14 patients with non-active secondary progressive multiple sclerosis. Over roughly one year of follow-up, the therapy remained extremely well tolerated during extended treatment.
Patients showed trends toward stabilization of disability on the Expanded Disability Status Scale and meaningful fatigue improvements on the Modified Fatigue Impact Scale, with 64% achieving a clinically important MFIS score gain. The company notes these findings are based on a small open-label cohort and are not statistically significant, but believes the longer-term trends support continued development of intranasal foralumab in progressive multiple sclerosis.
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Insights
Early Expanded Access data suggest tolerability and symptomatic benefits but remain non-definitive.
Tiziana shared longer-term data from 14 non-active SPMS patients receiving intranasal foralumab under Expanded Access. The company highlights continued excellent tolerability over extended dosing, which is important for a chronic neuroinflammatory condition where long-term safety can limit use.
Clinical signals include disability stabilization on the EDSS and fatigue improvements on the MFIS, with 9 of 14 patients achieving at least a 4‑point MFIS benefit. However, the company explicitly describes these as trend-level outcomes without statistical significance, reflecting the small, open-label cohort.
The data primarily support the biological plausibility and safety profile of intranasal foralumab while the more rigorous Phase 2a randomized, double-blind, placebo-controlled trial in non-active SPMS progresses. Subsequent results from that study will be key to determining whether these trends translate into confirmatory evidence.
Key Figures
Key Terms
Expanded Access Program regulatory
Expanded Disability Status Scale (EDSS) medical
Modified Fatigue Impact Scale (MFIS) medical
non-active Secondary Progressive Multiple Sclerosis (na-SPMS) medical
Phase 2a, randomized, double-blind, placebo-controlled trial medical
fully human anti-CD3 monoclonal antibody medical
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
May 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 ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On May 19, 2026, Tiziana Life Sciences LTD (the “Company”) issued this 6-K announcing, updated clinical data from its ongoing Expanded Access (“EA”) Program evaluating intranasal foralumab in 14 patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The data, updated from March 2025 to as of March 2026, demonstrate that intranasal foralumab continues to be extremely well tolerated over extended treatment durations. Patients showed encouraging trends in stabilization of disability as measured by the Expanded Disability Status Scale (EDSS) and meaningful improvements in fatigue as measured by the Modified Fatigue Impact Scale (MFIS).
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.
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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: May 19, 2026 | By: | /s/ Keeren Shah | |
| Name: | Keeren Shah | ||
| Title: | Chief Financial Officer | ||
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EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Tiziana Life Sciences LTD Press Release, dated May 19, 2026 |
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Exhibit 99.1
Tiziana Announces New Positive Clinical Data for Intranasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis
| ● | Favourable trends seen in stability of disability and clinically meaningful improvements in fatigue. |
BOSTON, MA, May 19, 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 updated clinical data from its ongoing Expanded Access (“EA”) Program evaluating intranasal foralumab in 14 patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The data, updated from March 2025 to as of March 2026, demonstrate that intranasal foralumab continues to be extremely well tolerated over extended treatment durations. Patients showed encouraging trends in stabilization of disability as measured by the Expanded Disability Status Scale (EDSS) and meaningful improvements in fatigue as measured by the Modified Fatigue Impact Scale (MFIS).
Study Highlights:
| ● | Safety: Foralumab was well tolerated with no new safety signals identified. |
| ● | EDSS Stabilization: We observed a favorable trend toward disease stabilization (i.e., reduced Confirmed Disability Progression (CDP). |
| ● | Fatigue Improvement: 64% of patients achieved a clinically meaningful improvement of ≥4 points in their MFIS score. |
Figure 1. Foralumab Expanded Access Program vs. HERCULES Reference Arms
The graph titled “Foralumab Expanded Access Program vs Hercules Reference Arms” compares the cumulative incidence of disability progression events in the foralumab EA cohort against the placebo and tolebrutinib arms from the Phase 3 HERCULES non-relapsing SPMS trial (DOI: 10.1056/NEJMoa2415988). The foralumab line shows only a single event, indicating strong stabilization in the majority of treated patients. An “event” is defined per the Sanofi (Nasdaq: SNY) NEJM publication as a sustained increase in EDSS of ≥1.0 point if baseline EDSS <5.0, or ≥0.5 points if baseline EDSS ≥5.0.
Figure 2. Modified Fatigue Impact Scale (MFIS) Score
The graph titled “Modified Fatigue Impact Scale (MFIS) Score” shows 9 out of 14 participants (64%) achieved a clinically meaningful improvement of ≥4 points on the MFIS, consistent with criteria established by Rooney et al. (DOI: 10.1016/j.msard.2019.07.028).
Due to the small sample size in the Expanded Access Program, foralumab data shown in Figs 1 and 2 are not statistically significant and represent a trend analysis only.
Dr. Howard L. Weiner, Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, and Chair of the Scientific Advisory Board of Tiziana Life Sciences, commented: “These longer-term results from the Expanded Access SPMS Program continue to support the potential of intranasal foralumab as a novel, immunomodulatory therapy for patients with non-active SPMS. The excellent tolerability profile combined with trends toward disability stabilization and fatigue improvement is highly encouraging and warrants further investigation.”
Ivor Elrifi, CEO of Tiziana Life Sciences, added: “We are pleased with the continued positive safety and clinical trend data from our Expanded Access Program. Intranasal foralumab’s unique mechanism, which reduces neuroinflammation, positions it as a potential new treatment paradigm for progressive forms of multiple sclerosis where treatment options remain limited. We look forward to advancing this program to approval.”
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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]
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, 2025, 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
[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
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