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

Fatigue improved at both doses, while the exploratory higher-dose arm enrolled fewer patients to meet study timelines.

Rhea-AI Summary

Tiziana Life Sciences (TLSA) reported additional Phase 2a INFORM-MS findings supporting intranasal foralumab in non-active secondary progressive multiple sclerosis. The placebo-controlled, 12-week study reported dual primary endpoint success. The 50 μg arm reduced microglial activation, a measure of brain immune-cell activity, versus placebo on PET imaging (p=0.0168). Fatigue scores improved from baseline by 6.17 points at 50 μg and 7.18 points at 100 μg; the study was not powered for this endpoint.

The 100 μg arm was exploratory, with 11 patients versus 19 at 50 μg. In a published, open-label expanded access cohort, all 10 patients stabilized on a disability scale, and three of four treated continuously for 12 months improved. No drug-related serious adverse events occurred over more than 37.4 patient-years of exposure. The ongoing expanded access program includes 14 patients, some treated for up to three years.

13 points · 1 major

PositiveiHow this balance works

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0 major · 4 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointINFORM-MS reported dual primary endpoint success in a placebo-controlled, 12-week Phase 2a study.
• Minor point50 μg foralumab reduced PET-measured microglial activation versus placebo (p=0.0168).
• Minor pointFatigue scores improved from baseline: 50 μg, –6.17 points (p=0.035); 100 μg, –7.18 points (p=0.040).
• Minor pointBoth INFORM-MS doses showed a favorable safety and tolerability profile.
• Minor pointPublished expanded access data showed all 10 patients stabilized on the Expanded Disability Status Scale.

8 minor points

• Minor pointThree of four patients treated continuously for 12 months improved on the disability scale.
• Minor pointSeven of ten patients improved on the fatigue scale after six months of expanded access treatment.
• Minor pointNo drug-related serious adverse events occurred over more than 37.4 patient-years of cumulative exposure.
• Minor pointExpanded access PET signals declined over six months (p < 0.05), consistent with reduced microglial activation.
• Minor pointExpanded access testing showed increased TGFβ expression, a regulatory immune response, across multiple cell subsets.
• Minor pointNo anti-drug antibodies were detected in evaluated serum samples, including through 15–17 months in the longest-treated patients.
• Minor pointUpdated 14-patient expanded access data showed favorable tolerability and trends toward disability stabilization and clinically meaningful fatigue improvement.
• Minor point. Forward-looking: it has not happened yet and may not happen.Tiziana plans detailed INFORM-MS presentation at an upcoming scientific meeting and FDA discussions on next steps.

Negative

• Minor pointFatigue endpoint improvements came from a study not powered to test that endpoint.
• Minor point100 μg arm was exploratory; 11 patients enrolled to meet timelines, versus 19 at 50 μg.
• Minor pointExpanded access evidence is open-label; the published cohort included ten patients.
• Minor pointFull INFORM-MS dataset analysis remains to be completed.

Key Figures

Microglial activation p-value: p=0.0168 MFIS change: −6.17 points; p=0.035 MFIS change: −7.18 points; p=0.040 +5 more

Microglial activation p-value

p=0.0168

50 μg dose versus placebo in INFORM-MS

MFIS change

−6.17 points; p=0.035

50 μg arm after 12 weeks

MFIS change

−7.18 points; p=0.040

100 μg arm after 12 weeks

EDSS stabilization

10 of 10 patients

Expanded access program

EDSS improvement

3 of 4 patients

Continuous treatment for 12 months

Fatigue improvement

7 of 10 patients

MFIS after 6 months of foralumab treatment

Cumulative exposure

More than 37.4 patient-years

No study-drug-related serious adverse events reported

Expanded access enrollment

14 patients; some treated for up to 3 years

Ongoing intermediate-size program

Previous Clinical trial Reports

1 past event · Latest: Nov 02

Same Type 1 event

1. Nov 02

   clinical trial

   24h Move

   -16.3%

   Reported INFORM-MS dual primary endpoint success, establishing the trial findings discussed in this follow-up call.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

anti-CD3 monoclonal antibody, microglial activation, progression independent of relapse activity, modified fatigue impact scale, +2 more

6 terms

anti-CD3 monoclonal antibody medical

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

A lab-made antibody engineered to attach to CD3, a protein found on T cells, so it can change how those immune cells behave. Investors care because these drugs can act like a targeted brake on an overactive immune system—useful for autoimmune disease, transplant rejection or as part of cancer therapies—but they also carry clinical trial, safety and regulatory risks that determine commercial success.

microglial activation medical

"Statistically significant reduction in microglial activation"

Microglial activation is when the brain’s resident immune cells — microglia — switch from a resting, maintenance role into an alert, defensive state, similar to a neighborhood cleanup crew suddenly racing to douse a small fire. For investors, this matters because persistent or excessive activation is a hallmark of many neurological diseases, affects how drugs perform in trials, and can drive regulatory and market reactions to therapies aimed at calming or harnessing this response.

progression independent of relapse activity medical

"progression independent of relapse activity (PIRA)"

Progression independent of relapse activity (PIRA) is a measure used in multiple sclerosis clinical research to describe a sustained increase in neurological disability that occurs without an intervening clinical relapse. It is identified when a patient shows confirmed worsening on a standardized disability scale (for example, a lasting increase in Expanded Disability Status Scale score or another pre-specified clinical test) that is not preceded or accompanied by a relapse within the trial’s defined time window, so the worsening is attributed to underlying, non-relapse disease activity rather than an acute attack. How PIRA is counted depends on the study’s specific definitions of ‘‘relapse’’ and the required confirmation period, so comparisons across studies require attention to those criteria.

modified fatigue impact scale medical

"Modified Fatigue Impact Scale (MFIS) scores from baseline"

A standardized questionnaire that measures how fatigue affects a person’s day-to-day functioning across physical, cognitive and social areas. Investors use it as an outcome measure in clinical trials and patient studies to judge whether a therapy or intervention produces meaningful improvement—think of it like a customer satisfaction score that quantifies whether a treatment actually helps people feel and function better. Results can influence regulatory decisions, market expectations and commercial value.

expanded disability status scale medical

"Expanded Disability Status Scale (EDSS) scores"

A clinical scale used by doctors to rate a person's level of physical disability, especially for tracking progression of long-term neurological conditions. It assigns a score based on mobility, coordination and daily function—like a report card for how well someone can move and care for themselves—and is widely used in medical trials to show whether a treatment slows or reverses decline. Investors watch these scores because changes can signal a drug’s effectiveness, regulatory outcomes, market approval prospects and future sales.

anti-drug antibodies medical

"No anti-drug antibodies (ADAs) were detected"

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.

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BOSTON, Nov. 09, 2026 (GLOBE NEWSWIRE) -- 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, where we have seen 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.

“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.

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.

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

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

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

FAQ

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

What did Tiziana's INFORM-MS trial show at the 50 μg dose?

The 50 μg dose significantly reduced microglial activation versus placebo on PET imaging after 12 weeks (p=0.0168). This arm enrolled 19 patients and was powered for statistical significance on that imaging endpoint.

How much did fatigue improve in Tiziana's INFORM-MS trial?

Fatigue scores improved from baseline by 6.17 points at 50 μg (p=0.035) and 7.18 points at 100 μg (p=0.040) after 12 weeks. The improvements exceeded the threshold for clinical relevance, although the study was not powered for the fatigue endpoint.

Why was the 100 μg dose exploratory in Tiziana's INFORM-MS trial?

The 100 μg arm explored immune-modulating effects because earlier Phase 1 observations showed less immune modulation at higher doses, such as 250 μg, relative to 50 μg. Fewer patients enrolled in this arm to meet study timelines.

What are Tiziana's next steps for intranasal foralumab after INFORM-MS?

Tiziana plans to complete the full INFORM-MS analysis, discuss next steps with the FDA and present detailed findings at an upcoming scientific meeting. The company continues to evaluate development in progressive multiple sclerosis and other neurodegenerative indications.