Phase 2a MS trial fully enrolled at Tiziana Life Sciences (NASDAQ: TLSA)
Rhea-AI Filing Summary
Tiziana Life Sciences reports that it has fully enrolled its randomized, double-blind, placebo-controlled Phase 2a clinical trial of intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The INFORM-MS study has enrolled 48 patients at U.S. sites to receive one of two doses of intranasal foralumab or placebo over a 12-week treatment period.
Topline data are expected in late Q3 2026 and are planned to be presented at the 10th joint ACTRIMS/ECTRIMS meeting in Toronto in October 2026. After the blinded phase, all participants, including prior placebo recipients, may receive intranasal foralumab in a six-month open-label extension to assess long-term safety and sustained benefit.
The company highlights foralumab as the only fully human anti-CD3 monoclonal antibody currently in clinical development and notes an open-label Expanded Access program in 14 na-SPMS patients, where improvement or disease stability within six months has been observed.
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Insights
Enrollment completion de-risks execution of Tiziana’s Phase 2a MS trial, but data in late Q3 2026 remain the key catalyst.
The company has fully enrolled 48 na-SPMS patients in INFORM-MS, a randomized, double-blind, placebo-controlled Phase 2a trial of intranasal foralumab. Completing enrollment reduces operational risk and locks in a clear timeline, with a 12-week blinded treatment phase followed by a six-month open-label extension.
INFORM-MS is described as the first Phase 2 placebo-controlled study of intranasal foralumab, using PET imaging, MRI, clinical evaluations, and biomarkers. The filing also notes 14 Expanded Access patients with improvement or stability at six months, but these are open-label observations rather than controlled data.
The most tangible near-term inflection point is the planned topline readout in late Q3 2026 and its presentation at the ACTRIMS/ECTRIMS meeting in October 2026. Until those results are available, this development mainly confirms trial progress rather than demonstrating efficacy or changing the overall risk profile.
Key Figures
Key Terms
Phase 2a clinical trial medical
non-active Secondary Progressive Multiple Sclerosis (na-SPMS) medical
open label extension (OLE) medical
Expanded Access (EA) Program medical
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 21, 2026, Tiziana Life Sciences LTD (the “Company”) issued this 6K announcing, that patient enrollment has been completed in its randomized, double-blind, placebo-controlled Phase 2a clinical trial evaluating intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). Topline data is expected in late Q3 of 2026, and will also to be presented at the 10th joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and ECTRIMS meeting in Toronto, Canada in October 2026.
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.
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: May 21, 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 May 21, 2026 |
3
Exhibit 99.1
Tiziana Fully Enrolls its Phase 2 Placebo Controlled Multiple Sclerosis Trial
BOSTON, MA, May 21, 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 patient enrollment has been completed in its randomized, double-blind, placebo-controlled Phase 2a clinical trial evaluating intranasal foralumab in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). Topline data is expected in late Q3 of 2026, and will also to be presented at the 10th joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and ECTRIMS meeting in Toronto, Canada in October 2026.
The trial (NCT06292923), known as INFORM-MS, is the first Phase 2 placebo-controlled study of intranasal foralumab, marking a significant milestone in the clinical development of this novel anti-CD3 monoclonal antibody for neurodegenerative and neuroinflammatory diseases. The multicenter study has enrolled 48 patients across multiple leading U.S. sites to receive one of two doses of intranasal foralumab or placebo over a 12-week treatment period, with assessments including PET imaging for microglial activation, MRI, clinical evaluations, and biomarkers. Following the completion of the blinded phase, all participants including those who initially received placebo will have the opportunity to receive intranasal foralumab during a six-month open label extension (OLE) phase. The OLE is designed to assess long term safety and sustained benefit of foralumab in the na-SPMS patient population.
“This completion of enrollment in our Phase 2a trial represents a pivotal moment for Tiziana Life Sciences and for patients suffering from na-SPMS, a condition with limited treatment options,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. “As the first placebo-controlled trial of intranasal foralumab, this study underscores our commitment to rigorously evaluating this innovative therapy’s potential to modulate the immune system and address neuroinflammation. We are grateful for the dedication of our clinical partners and look forward to sharing topline results that could pave the way for a new treatment paradigm.”
Gabriele Cerrone, Executive Chairman and Founder of Tiziana Life Sciences, added: “Reaching full enrollment in this landmark study is a testament to the strong belief in foralumab’s potential and the urgent need for effective therapies in secondary progressive MS. Intranasal delivery offers a novel, non-invasive route that targets the brain’s immune mechanisms directly. This achievement highlights the progress of our pipeline and brings us closer to delivering transformative benefits to patients.”
The Company extends its sincere gratitude to the Principal Investigator, Dr. Tanuja Chitnis, Senior Neurologist at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system along with the entire team of investigators and clinical sites for their exceptional commitment and expertise in advancing this important trial.
For more information on the trial, please visit ClinicalTrials.gov (NCT06292923).
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, 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