Tiziana Life Sciences Announces New Biomarker Data Showing Nasal Foralumab Downregulates CSF Inflammation, Upregulates Neuroprotective Pathways, and Correlates with Reduced Microglial Activation on PET Scans in na-SPMS Patients with PIRA

Rhea-AI Summary

Tiziana Life Sciences (Nasdaq: TLSA) reported biomarker results showing intranasal foralumab reduced PET-measured microglial activation and shifted CSF proteomics toward decreased inflammation and increased neuroprotection in na-SPMS patients with PIRA.

Findings from 10 patients (14 paired evaluations) showed significant PET m-GALP z-score reductions (p<0.05 at 3 months+), strong correlations between PET and CSF proteins (r up to 0.896 and -0.931, p<0.05), clinical stabilization/improvement, and no serious treatment-related adverse events. Phase 2a top-line data expected H1 2026.

Positive

• Significant PET microglial reduction (p<0.05 at 3 months)
• CSF inflammatory proteins downregulated (e.g., IFNAR1, LY86)
• CSF neuroprotective proteins upregulated (e.g., MEG10)
• Strong PET–CSF correlations (r up to 0.896 and -0.931)
• Clinical stabilization/improvement with no serious treatment-related AEs
• Phase 2a randomized trial ongoing; top-line data expected H1 2026

Negative

• Small sample size of 10 patients limits statistical power
• Open-label expanded-access design lacks randomized placebo control

Key Figures

Patients in poster study: 10 patients Paired evaluations: 14 paired evaluations Treatment duration: up to 6 months +5 more

8 metrics

Patients in poster study 10 patients na-SPMS with PIRA treated with nasal foralumab in expanded-access program

Paired evaluations 14 paired evaluations [F-18]PBR06-PET scans and CSF proteomics at baseline and during treatment

Treatment duration up to 6 months Nasal foralumab treatment period for biomarker and PET assessment

PET significance p<0.05 Reduced voxel-wise average PET m-GALP z-scores at 3 months and later follow-up

Max positive correlation r up to 0.896 Correlation between PET m-GALP z-scores and inflammatory CSF proteins

Max negative correlation r up to -0.931 Correlation between PET m-GALP z-scores and neuroprotective CSF proteins

Phase Phase 2a Randomized, double-blind, placebo-controlled trial in na-SPMS (NCT06292923)

Top-line data timing first half of 2026 Expected top-line readout for Phase 2a na-SPMS trial

Market Reality Check

Price: $1.34 Vol: Volume 76,359 is below th...

low vol

$1.34 Last Close

Volume Volume 76,359 is below the 20-day average of 153,138, indicating a lighter participation on a 7.2% move. low

Technical Shares at $1.34 are trading below the 200-day moving average of $1.70 and remain 48.46% under the 52-week high.

Peers on Argus

TLSA gained 7.2% on positive na‑SPMS biomarker data while only one scanned peer ...

1 Down

TLSA gained 7.2% on positive na‑SPMS biomarker data while only one scanned peer (KYTX) showed downside momentum and several other biotech peers had mixed, mostly smaller moves. This points to a stock-specific reaction rather than a broad sector rotation.

Historical Context

5 past events · Latest: Jan 20 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 20	Clinical publication	Positive	-6.0%	Peer-reviewed na‑SPMS intranasal foralumab study with imaging and biomarker data.
Jan 16	Financing close	Positive	+15.9%	Closing oversubscribed $8.8M registered direct offering with attached warrants.
Jan 16	Financing pricing	Positive	+15.9%	Pricing of $8.0M registered direct offering with additional warrant proceeds potential.
Jan 09	Conference presentation	Positive	-3.4%	Announcement of CEO presentation at Neuroscience Innovation Forum highlighting foralumab.
Dec 29	Safety update	Positive	+4.7%	Annual FDA safety report showing 37.4 patient-years with no serious drug-related events.

Pattern Detected

Recent history shows positive clinical and financing news often met with mixed price reactions, including selloffs on strong scientific updates but rallies on insider-led financings.

Recent Company History

Over the past two months, TLSA has repeatedly highlighted intranasal foralumab in na‑SPMS. A Dec 29 annual FDA safety report cited 37.4 patient-years of exposure with no drug-related serious adverse events, followed by a Jan 9 JPM-week forum presentation and a Jan 20 peer-reviewed publication integrating TSPO-PET, proteomics, and clinical data. Capital raises on Jan 16 totaling gross proceeds of about $8.8M supported Phase 2 na‑SPMS and MSA trials. Today’s new biomarker/imaging data further builds the mechanistic package around foralumab in progressive MS.

Market Pulse Summary

This announcement adds detailed biomarker and PET imaging evidence that nasal foralumab reduced micr...

Analysis

This announcement adds detailed biomarker and PET imaging evidence that nasal foralumab reduced microglial activation and shifted CSF proteins toward a more neuroprotective profile in 10 na‑SPMS patients over up to 6 months. Together with prior safety data and the ongoing Phase 2a trial, it strengthens the mechanistic case without yet providing pivotal outcomes. Investors may watch for larger controlled datasets, durability of effect, regulatory interactions, and future capital plans as key next checkpoints.

Key Terms

cerebrospinal fluid, microglial activation, monoclonal antibody, anti-cd3, +2 more

6 terms

cerebrospinal fluid medical

"In multiple sclerosis (MS)... Cerebrospinal fluid (CSF) plays a crucial role in diagnosis"

A clear fluid that surrounds and cushions the brain and spinal cord, acting like a protective bath and cleanup system that removes waste and helps circulate nutrients. For investors, cerebrospinal fluid matters because it is a common source of diagnostic markers and a route for delivering or testing neurological drugs; changes in its composition can signal disease or affect a therapy’s development, approval prospects, and market value.

microglial activation medical

"[F-18]PBR06-PET scans (measuring microglial activation via m-GALP z-scores)"

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.

monoclonal antibody medical

"intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces positive new biomarker data"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

anti-cd3 medical

"intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces positive new biomarker data"

An anti‑CD3 is an antibody drug that binds to the CD3 protein on T cells, the immune system’s frontline soldiers, to change how those cells behave. Think of it like attaching a remote control to specific immune cells to dial their activity up, down or redirect them; for investors, anti‑CD3 therapies signal a drug class with significant promise in autoimmune diseases, transplant protection and certain cancer strategies, but also carry clinical, regulatory and safety risks that strongly influence valuation and trial outcomes.

tsop-pet medical

"first na-SPMS study to integrate TSPO-PET imaging, proteomics, and clinical assessments"

TSPO-PET is a type of medical imaging that uses a radioactive tracer to visualize the translocator protein (TSPO), which becomes more abundant when immune cells in the brain or other organs are activated. Think of it like a dye that lights up areas of inflammation, providing a measurable biomarker that drug developers and investors use to track disease activity, judge whether a treatment is hitting its target, and de‑risk clinical trials or diagnostics development.

phase 2a medical

"ongoing randomized, double-blind, placebo-controlled Phase 2a trial (NCT06292923) in na-SPMS"

Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.

AI-generated analysis. Not financial advice.

BOSTON, Feb. 25, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana”), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces positive new biomarker data from a late-breaking poster titled “Nasal foralumab downregulates CSF inflammation and upregulates CSF neuroprotective proteomic pathways which correlate with [F-18]PBR06-PET imaging in na-SPMS with PIRA,” which was presented by investigators from Brigham and Women’s Hospital, Boston, MA.

In multiple sclerosis (MS), an autoimmune disease involving inflammation, demyelination, and neurodegeneration in the CNS, Cerebrospinal fluid (CSF) plays a crucial role in diagnosis, understanding disease mechanisms, and monitoring progression, especially in progressive forms like non-active secondary progressive MS (na-SPMS) with progression independent of relapse activity (PIRA). CSF analysis, typically obtained via lumbar puncture, provides direct insight into CNS-specific processes because it reflects the local environment around the brain and spinal cord, unlike blood which can be influenced by systemic factors.

The late-breaking poster reports results from 10 patients with non-active secondary progressive multiple sclerosis (na-SPMS) and progression independent of relapse activity (PIRA) treated with nasal foralumab in an open-label expanded-access program. Patients underwent 14 paired evaluations of [F-18]PBR06-PET scans (measuring microglial activation via m-GALP z-scores) and untargeted data-independent acquisition CSF proteomics at baseline and during up to 6 months of treatment.

Key findings include:

• Nasal foralumab treatment significantly reduced voxel-wise average [F-18]PBR06-PET m-GALP z-scores in white matter and global brain regions (p<0.05 at 3 months and later follow-up), confirming decreased microglial activation.
• CSF proteomics showed downregulation of inflammatory biomarkers (e.g., IFNAR1 in the interferon pathway and LY86 in the NF-κB pathway) and upregulation of neuroprotective proteins (e.g., MEG10).
• Strong positive correlations were observed between PET m-GALP z-scores and inflammatory CSF proteins (e.g., IFNAR1 in high-affinity TSPO binders across whole brain, cortex, and cerebellum; r values up to 0.896, p<0.05). Negative correlations were seen with neuroprotective proteins (e.g., MEG10 and COBA1 in fibrosis-related pathways; r values up to -0.931, p<0.05).
• These biomarker changes occurred alongside clinical stabilization or improvement, with no serious treatment-related adverse events.

“This late-breaking poster provides the first direct link between reduced microglial PET signal and favorable CSF proteomic shifts during nasal foralumab treatment in na-SPMS with PIRA,” said Tarun Singhal, M.D., lead author and neurologist at Brigham and Women’s Hospital. “The correlations demonstrate that [F-18]PBR06-PET is biologically tied to the inflammatory and neurodegenerative processes driving progression in SPMS, and that CSF proteomics can serve as a practical biomarker of therapeutic response.”

Howard L. Weiner, M.D., Chairman of Tiziana’s Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, added: “Nasal foralumab continues to show a unique ability to dampen smoldering CNS inflammation while promoting neuroprotection. These integrated imaging and proteomic results strengthen the mechanistic rationale for our ongoing Phase 2 program and offer new tools to monitor disease modification in progressive MS.”

Tiziana is advancing intranasal foralumab in an ongoing randomized, double-blind, placebo-controlled Phase 2a trial (NCT06292923) in na-SPMS, with top-line data expected in the first half of 2026. Nasal foralumab's innovative intranasal delivery modulates the immune system to suppress microglial-driven neuroinflammation without broad systemic immunosuppression, distinguishing it from existing MS therapies. The Company is also evaluating the therapy in additional neuroinflammatory indications such as MSA, Alzheimer’s and ALS.

The poster can be found here: https://www.tizianalifesciences.com/publications/

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, 2024, 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

FAQ

What did Tiziana (TLSA) report about nasal foralumab effects on PET in na-SPMS on Feb 25, 2026?

Nasal foralumab significantly reduced PET m-GALP z-scores in white matter and global brain regions (p<0.05). According to Tiziana, reductions were seen at three months and later, indicating decreased microglial activation in treated na-SPMS patients.

How did CSF proteomics change after nasal foralumab treatment in TLSA’s na-SPMS patients?

CSF proteomics showed downregulation of inflammatory markers and upregulation of neuroprotective proteins. According to Tiziana, examples include decreased IFNAR1 and LY86 and increased MEG10, reflecting reduced inflammation and enhanced neuroprotection.

Do PET and CSF biomarkers correlate in TLSA’s nasal foralumab data for na-SPMS with PIRA?

Yes — strong positive and negative correlations were observed between PET and CSF proteins (r up to 0.896 and -0.931). According to Tiziana, these correlations link PET microglial signals to inflammatory and neuroprotective CSF pathways.

Were there safety or clinical outcome signals reported for TLSA’s intranasal foralumab in na-SPMS?

No serious treatment-related adverse events were reported, and patients showed stabilization or improvement clinically. According to Tiziana, biomarker changes occurred alongside clinical stabilization or improvement in the treated cohort.

What are the next clinical milestones for TLSA’s nasal foralumab in na-SPMS?

Top-line data from the randomized, double-blind Phase 2a (NCT06292923) are expected in the first half of 2026. According to Tiziana, the ongoing trial will provide controlled data to validate these biomarker and clinical signals.