Tiziana Life Sciences Announces the Peer-Reviewed Publication of Clinical Study Results for Intranasal Foralumab

Rhea-AI Summary

Tiziana Life Sciences (Nasdaq: TLSA) announced peer-reviewed publication of an open-label study of intranasal foralumab in non-active secondary progressive multiple sclerosis (na-SPMS) in Neurology Neuroimmunology & Neuroinflammation on Jan 20, 2026. The 10-patient study reported no serious treatment-related adverse events, stabilization of EDSS in all patients with improvement in 3 of 4 treated 12 months, MFIS fatigue improvement in 6 of 10, no new T2 MRI lesions, reduced microglial activation by TSPO-PET (p<0.05), and single-cell RNA-seq showing increased Tregs and TGFβ. A randomized double-blind Phase 2 in na-SPMS is ongoing with top-line data expected in 1H 2026.

Positive

• No serious treatment-related adverse events reported in 10 na-SPMS patients
• Clinical stabilization of EDSS in all patients; 3 of 4 treated 12 months showed improvement
• Biomarker evidence: TSPO-PET microglial activation reduced at 3 and 6 months (p<0.05)

Negative

• Small open-label cohort of 10 patients limits statistical generalizability
• Evidence pre‑registrational: randomized double-blind Phase 2 still ongoing, top-line data pending 1H 2026

News Market Reaction

-5.95%

5 alerts

-5.95% News Effect

-5.1% Trough in 23 hr 32 min

-$13M Valuation Impact

$205M Market Cap

0.9x Rel. Volume

On the day this news was published, TLSA declined 5.95%, reflecting a notable negative market reaction. Argus tracked a trough of -5.1% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $13M from the company's valuation, bringing the market cap to $205M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Patients treated: 10 patients Treatment duration: ≥6 months 12-month subgroup: 3 of 4 improved +5 more

8 metrics

Patients treated 10 patients na-SPMS open-label intranasal foralumab study

Treatment duration ≥6 months Minimum intranasal foralumab exposure in na-SPMS study

12-month subgroup 3 of 4 improved EDSS improvement among patients treated 12 months

Fatigue improvement 6 of 10 patients MFIS-measured fatigue improvement in na-SPMS cohort

MRI lesions 0 new T2 lesions Brain MRI findings during intranasal foralumab treatment

TSPO-PET significance p<0.05 Reduced microglial activation at 3 and 6 months

Trial phase Phase 2 Ongoing randomized na-SPMS trial of intranasal foralumab

Top-line timing 1H 2026 Expected readout from randomized Phase 2 na-SPMS trial

Market Reality Check

Price: $1.39 Vol: Volume 1,504,600 is about...

high vol

$1.39 Last Close

Volume Volume 1,504,600 is about 5.3x the 20-day average of 283,743, indicating unusually high interest ahead of this clinical update. high

Technical Price $1.68 is trading slightly above the 200-day MA of $1.66 and is 35.38% below the 52-week high and 166.58% above the 52-week low.

Peers on Argus

TLSA gained 15.86% with strong volume, while momentum scanners only flagged two ...

2 Up

TLSA gained 15.86% with strong volume, while momentum scanners only flagged two other biotech names (VOR up 11.11%, ACRS up 34.16%) that lack related news. Core higher-affinity peers (TRDA, KYTX, SLS, THRD, VYGR) show mixed, stock-specific moves, pointing to a TLSA-specific reaction.

Historical Context

5 past events · Latest: Jan 16 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 16	Equity financing	Neutral	+15.9%	Closing of insider-participated $8.8M registered direct with attached warrants.
Jan 16	Equity financing	Neutral	+15.9%	Pricing of registered direct offering to raise up to $17.6M gross proceeds.
Jan 09	Conference presentation	Positive	-3.4%	Neuroscience forum presentation focused on intranasal foralumab program.
Dec 29	Safety update	Positive	+4.7%	Annual FDA safety report showing 37.4 patient-years with no serious events.
Dec 19	Insider share purchase	Positive	+5.6%	Executive Chairman increased holdings to over 43M common shares.

Pattern Detected

Recent TLSA headlines, including financings and clinical/visibility milestones, often coincided with positive or mixed price moves, suggesting investors have been responsive to both capital-raising and pipeline progress updates.

Recent Company History

Over the last few months, TLSA combined insider-led financings and steady clinical progress for intranasal foralumab. On Dec 19, 2025, the Executive Chairman increased his stake, followed by an FDA safety update with 37.4 patient-years of exposure and no serious events. January 2026 brought conference visibility and an insider-participated registered direct offering that lifted the stock 15.86%. Today’s peer-reviewed Phase 2 na‑SPMS data publication reinforces this pattern of advancing the foralumab franchise across neuro indications.

Market Pulse Summary

The stock moved -6.0% in the session following this news. A negative reaction despite peer-reviewed ...

Analysis

The stock moved -6.0% in the session following this news. A negative reaction despite peer-reviewed na‑SPMS data would have contrasted with TLSA’s history of generally constructive responses to clinical milestones and safety updates. Past clinical-trial headlines around foralumab produced average moves of about 7.12%, often positive. Any sharp downside would have highlighted concerns about data interpretation, prior financings, or trial risk, and might have signaled increased sensitivity to future readouts or funding developments.

Key Terms

tsop-pet, proteomics, expanded disability status scale, modified fatigue impact scale, +4 more

8 terms

tsop-pet medical

"This marks the first study to integrate TSPO-PET imaging, proteomics, and"

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.

proteomics medical

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

Proteomics is the large-scale study of all the proteins produced by a cell, tissue or organism, like taking a full inventory and watching how the workforce and machines inside a factory behave. For investors, proteomics matters because it helps identify drug targets, disease indicators and responses to treatments—information that can speed development, reduce risk, guide partnerships and reveal new commercial opportunities in biotech and diagnostics.

expanded disability status scale medical

"All patients showed stabilization of 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.

modified fatigue impact scale medical

"Fatigue improved in six out of ten patients, as measured by the Modified Fatigue Impact Scale"

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.

regulatory t cells medical

"RNA sequencing demonstrated sustained increases in regulatory T cells (Tregs) and TGFβ"

Regulatory T cells are a specialized type of immune cell that act like a brake on the body’s defense system, preventing it from attacking healthy tissue or causing chronic inflammation. They matter to investors because drugs that increase or block these cells can change treatment success and safety in areas such as autoimmune disease, organ transplants, and cancer immunotherapy, affecting clinical trial results, approval chances, and commercial value.

tgfβ medical

"sustained increases in regulatory T cells (Tregs) and TGFβ expression, supporting"

TGFβ (transforming growth factor beta) is a small signaling protein that helps control how cells grow, divide, heal wounds and respond to inflammation; think of it as a cellular thermostat and traffic cop that directs biological behavior. It matters to investors because drugs or therapies that change TGFβ activity can affect disease progression, safety and regulatory outcomes in areas like cancer, fibrosis and immune disorders, and thus influence clinical trial success and a company’s valuation.

microglial activation medical

"TSPO-PET imaging revealed significant reductions in microglial activation at three"

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.

double-blind, placebo-controlled medical

"advancing intranasal foralumab in an ongoing randomized, double-blind, placebo-controlled Phase 2 trial"

A clinical trial design in which participants are randomly assigned to receive either the experimental treatment or an inactive substitute (a placebo), and neither the participants nor the researchers know who is receiving which. This setup limits bias and makes it far easier to tell whether a drug or intervention truly works, similar to a blind taste test, so results carry more weight for regulatory decisions and for investors assessing a product’s commercial prospects.

AI-generated analysis. Not financial advice.

BOSTON, Jan. 20, 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 the peer-reviewed publication of its open-label study in patients with non-active secondary progressive multiple sclerosis (na-SPMS) in Neurology Neuroimmunology & Neuroinflammation, a prestigious journal of the American Academy of Neurology.

The publication, titled “Nasal Foralumab for the Treatment of Progression Independent of Relapses in Patients with Non-active Secondary Progressive Multiple Sclerosis,” details the comprehensive positive results previously announced by the Company on May 6, 2025. This marks the first study to integrate TSPO-PET imaging, proteomics, and clinical assessments in na-SPMS, highlighting nasal foralumab's novel mechanism in addressing progression independent of relapse activity (PIRA)—a critical unmet need in multiple sclerosis (MS) treatment.

Key Study Highlights:

• Ten patients with na-SPMS, progressing despite prior B-cell therapies, received nasal foralumab for at least six months.
• No serious or severe treatment-related adverse events occurred.
• All patients showed stabilization of Expanded Disability Status Scale (EDSS) scores; three of four treated for 12 months demonstrated improvement.
• Fatigue improved in six out of ten patients, as measured by the Modified Fatigue Impact Scale (MFIS)—a vital quality-of-life measure for MS patients.
• No new T2 lesions appeared on MRI.
• TSPO-PET imaging revealed significant reductions in microglial activation at three and six months (p<0.05).
• Single-cell RNA sequencing demonstrated sustained increases in regulatory T cells (Tregs) and TGFβ expression, supporting induction of regulatory immunity.
  
  

“This peer-reviewed publication in a leading neurology journal represents a major milestone and external validation of intranasal foralumab's therapeutic potential in secondary progressive MS,” said Tanuja Chitnis, M.D., Principal Investigator and Senior neurologist at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system. “The integration of advanced imaging, immune profiling, and clinical outcomes underscores how nasal foralumab uniquely targets CNS inflammation through mucosal tolerance, offering hope for patients with limited options.”

Dr. Howard L. Weiner, M.D., Chairman of Tiziana’s Scientific Advisory Board, co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system, noted: “The observed clinical stabilization and microglial PET findings are supported by these new biomarker discoveries, providing compelling evidence of nasal foralumab's biological effects in addressing PIRA in na-SPMS.”

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.

Tiziana is advancing intranasal foralumab in an ongoing randomized, double-blind, placebo-controlled Phase 2 trial in na-SPMS, with top-line data expected in 1H of 2026.

“We are thrilled that these groundbreaking results have now been peer-reviewed and published, reinforcing our confidence in intranasal foralumab as a potential paradigm-shifting therapy for progressive MS and beyond,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences.

The full publication can be found here: https://www.neurology.org/doi/10.1212/NXI.0000000000200543

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]

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

FAQ

What did Tiziana (TLSA) publish on Jan 20, 2026 about intranasal foralumab?

A peer-reviewed open-label study in na-SPMS reporting safety, EDSS stabilization, MFIS fatigue improvements, no new T2 lesions, TSPO-PET microglial reductions (p<0.05), and immune biomarker changes.

How many patients were in the intranasal foralumab na-SPMS study reported by TLSA?

Ten patients with non-active secondary progressive MS were treated for at least six months in the published study.

What clinical and biomarker results did TLSA report for nasal foralumab in na-SPMS?

Stabilized EDSS in all patients, EDSS improvement in 3 of 4 at 12 months, MFIS fatigue improvement in 6 of 10, no new T2 lesions, and reduced microglial activation by TSPO-PET.

Does the published TLSA study prove efficacy of foralumab in progressive MS?

The publication shows promising safety, clinical stabilization, and biomarker changes but is from a small open-label cohort; confirmatory Phase 2 randomized data are pending.

When will TLSA report randomized Phase 2 top-line results for intranasal foralumab (TLSA)?

Tiziana expects top-line data from the ongoing randomized double-blind Phase 2 in na-SPMS in 1H 2026.