Tiziana Reports Reduced Brain Inflammation in Multiple System Atrophy Patients Treated with Intranasal Foralumab

Rhea-AI Summary

Tiziana Life Sciences (Nasdaq: TLSA) reported initial Phase 2 PET imaging data for intranasal foralumab in Multiple System Atrophy (MSA).

In the first two MSA patients, PET scans showed up to ~35% reduction in SUV and ~24% reduction in SUVR in disease-relevant brain regions, suggesting reduced neuroinflammatory activity.

This is the third indication with observed PET inflammation reduction for intranasal foralumab, following non-active secondary progressive multiple sclerosis and moderate Alzheimer’s disease.

AI-generated analysis. Not financial advice.

Positive

• Up to ~35% reduction in brain SUV and ~24% SUVR in first two MSA patients
• Quantitative PET reductions in basal ganglia and cerebellar white matter, regions implicated in MSA
• Third indication with PET evidence of reduced inflammation for intranasal foralumab
• Targeting MSA, a disease with no approved disease-modifying treatments

Negative

• Data currently limited to only two MSA patients in an ongoing Phase 2 trial
• No clinical outcome or functional efficacy results reported alongside imaging findings

News Market Reaction – TLSA

-3.33%

2 alerts

-3.33% News Effect

-$6M Valuation Impact

$181.98M Market Cap

0.4x Rel. Volume

On the day this news was published, TLSA declined 3.33%, reflecting a moderate negative market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $6M from the company's valuation, bringing the market cap to $181.98M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

SUV reduction: up to 35% reduction SUVR reduction: 24% reduction MSA patients: 2 patients +5 more

8 metrics

SUV reduction up to 35% reduction Standardized uptake value decrease in affected MSA brain regions (first two patients)

SUVR reduction 24% reduction Standardized uptake value ratio decrease in affected MSA brain regions

MSA patients 2 patients Initial Phase 2 intranasal foralumab PET imaging analysis in MSA

Net loss $18.4 million Year ended Dec 31, 2025 (Form 20-F)

Operating expenses $21.1 million Year ended Dec 31, 2025 (Form 20-F)

Cash and equivalents $4.0 million As of Dec 31, 2025 (Form 20-F)

Equity raise $8.6 million Equity financing in January 2026 (Form 20-F)

Share offering size 8,800,000 shares at $1.25 Primary offering with warrants (POS AM / 424B5, Jan 2026)

Market Reality Check

Price: $1.3700 Vol: Volume 278,261 is 1.78x t...

high vol

$1.3700 Last Close

Volume Volume 278,261 is 1.78x the 20-day average of 156,250, indicating elevated trading interest pre-news. high

Technical Shares at $1.50 are trading below the 200-day MA of $1.65 and sit 42.31% under the 52-week high.

Peers on Argus

TLSA was down 3.85% while key biotech peers like TRDA, KYTX, SLS, and VYGR showe...

1 Up

TLSA was down 3.85% while key biotech peers like TRDA, KYTX, SLS, and VYGR showed gains between 0.97% and 4.76%. Only one momentum-scanner peer (ACRS) appeared, moving up 3.88%, reinforcing this as stock-specific rather than a sector-wide move.

Historical Context

5 past events · Latest: Apr 16 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Apr 16	Preclinical Long COVID data	Positive	+0.8%	Mouse Long COVID model showed reduced neuroinflammation and improved cognition with foralumab.
Apr 14	MSA poster acceptance	Positive	+12.2%	Late-breaking Phase 2a MSA poster accepted for World Parkinson Congress presentation.
Apr 01	Aging cognition preclinical	Positive	+6.8%	Preclinical data showed nasal anti-CD3 reversed brain aging markers and improved cognition.
Feb 25	na-SPMS biomarker data	Positive	+4.5%	Biomarkers linked nasal foralumab to reduced CSF inflammation and PET microglial activation.
Jan 20	na-SPMS study publication	Positive	-6.0%	Peer-reviewed na-SPMS study publication with positive safety, PET, and clinical findings.

Pattern Detected

Recent neuroinflammation and foralumab updates have generally coincided with positive price reactions, with one notable negative move on a detailed clinical publication.

Recent Company History

Over the last several months, Tiziana has repeatedly highlighted intranasal foralumab’s potential across neuroinflammatory conditions. Events included peer‑reviewed publication of na‑SPMS data on Jan 20, 2026, new biomarker data on Feb 25, 2026, and aging-related preclinical findings on Apr 1, 2026. Long COVID preclinical data followed on Apr 16, 2026. Most of these announcements saw modest to strong gains, suggesting investor interest in mechanistic and clinical validation of foralumab, which today’s MSA PET findings further extend.

Market Pulse Summary

This announcement adds early quantitative PET support for intranasal foralumab in MSA, showing up to...

Analysis

This announcement adds early quantitative PET support for intranasal foralumab in MSA, showing up to 35% SUV and 24% SUVR reductions in key brain regions for 2 patients. It extends a series of neuroinflammation-focused updates across na‑SPMS, aging, and Long COVID. At the same time, Tiziana remains a clinical-stage company with a $18.4 million 2025 net loss and modest $4.0 million cash, making future capital raises and the scale of forthcoming MSA and na‑SPMS data important metrics to watch.

Key Terms

multiple system atrophy, standardized uptake value, standardized uptake value ratio, pet imaging, +4 more

8 terms

multiple system atrophy medical

"clinical trials for patients with Multiple System Atrophy"

A progressive neurological disorder that damages multiple areas of the nervous system, causing problems with movement, balance and involuntary functions like blood pressure and bladder control; think of it as critical wiring in the body slowly failing. Investors care because the condition defines the size and urgency of the market for treatments, influences clinical trial difficulty and regulatory risk, and can lead to high per-patient pricing but also greater development uncertainty.

standardized uptake value medical

"up to approximately 35% reduction in standardized uptake value (SUV)"

Standardized uptake value (SUV) is a single-number measure from a PET scan that shows how much of a radioactive tracer a specific area of the body absorbs, adjusted for the amount of tracer given and the patient’s size. Think of it like a brightness setting on a heat map that is normalized so different scans can be compared; higher or changing SUV values can indicate disease activity, treatment response, or drug effect, making it a useful metric for investors assessing clinical results or healthcare technologies.

standardized uptake value ratio medical

"and approximately 24% reduction in standardized uptake value ratio (SUVR)"

A standardized uptake value ratio (SUVr) is a number from a PET scan that compares how much of a radioactive tracer collects in a target area (like a tumor or brain region) versus a reference area of the body. Think of it as measuring how much brighter one spot is compared with normal background lighting. Investors care because SUVr provides an objective, repeatable signal of disease activity or drug effect, and changes in SUVr often drive clinical decisions, trial endpoints, regulatory reviews and market adoption for diagnostics and therapies.

pet imaging medical

"announces initial quantitative PET imaging results from the first two patients"

PET imaging is a noninvasive medical scan that works like a molecular camera, using tiny radioactive tracers to reveal biological activity inside the body—for example metabolism, blood flow, or the presence of specific proteins. It matters to investors because PET results guide diagnosis, show whether a drug reaches its intended target and how patients respond, and therefore affect clinical trial success, regulatory approval, reimbursement decisions and demand for scanners, tracers and related services.

monoclonal antibody medical

"foralumab, a fully human, anti-CD3 monoclonal antibody, announces initial"

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.

neurodegenerative medical

"involved in the neurodegenerative processes underlying MSA"

Neurodegenerative describes diseases where nerve cells in the brain or spinal cord progressively lose function and die, causing worsening movement, memory or other mental abilities over time. For investors this matters because such conditions create large, long-term needs for therapies and caregiving; developing treatments often requires lengthy, expensive research and regulatory testing but can lead to substantial, sustained market opportunities if a therapy proves effective — like fixing the wiring in a whole neighborhood rather than a single house.

neuroinflammation medical

"potential of our therapy to meaningfully address neuroinflammation across multiple"

Neuroinflammation is the brain or spinal cord’s immune reaction to injury, infection, or abnormalities, where cells and molecules become active to protect or repair nervous tissue. It matters to investors because it underlies many neurological diseases and is a common target for drugs and diagnostic tools; positive or negative trial results, safety signals, or new therapies can change a company’s value much like a major repair plan or recall would affect a carmaker’s prospects.

cerebellar ataxia medical

"disorder characterized by autonomic dysfunction, parkinsonism, and cerebellar ataxia."

A neurological condition caused by dysfunction of the cerebellum, the brain area that coordinates balance, walking, eye movements and fine motor skills; it leads to unsteady gait, poor hand coordination and speech problems. Investors watch cerebellar ataxia because it creates demand for therapies, medical devices and support services, influences clinical trial design and approval timelines, and can affect treatment costs—think of it as a vehicle’s steering system losing precision, prompting market activity around fixes.

AI-generated analysis. Not financial advice.

Foralumab is the first intranasal immune modulator in clinical trials for patients with Multiple System Atrophy

BOSTON, May 14, 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 initial quantitative PET imaging results from the first two patients with Multiple System Atrophy (MSA) in the Phase 2 clinical trial treated with intranasal foralumab. This is the third indication that has shown a marked reduction in inflammation on PET scans following treatment with intranasal foralumab.

Quantitative analysis of PET scans demonstrated reductions in inflammatory activity in clinically relevant brain regions known to be affected in MSA following treatment with intranasal foralumab. In the first two treated patients, investigators observed up to approximately 35% reduction in standardized uptake value (SUV) and approximately 24% reduction in standardized uptake value ratio (SUVR) in affected areas of the brain.

Figure 1. 2nd MSA patient on nasal foralumab

Significant reduction in basal ganglia and thalamic uptake following nasal foralumab

Figure 2. 2nd MSA patient on nasal foralumab

Marked reduction in Cerebellar white matter uptake following nasal foralumab

Figure 3. 1^st MSA patient on nasal foralumab

Marked reduction in basal ganglia uptake following nasal foralumab

The reductions were observed in regions including the basal ganglia and cerebellar white matter, which are known to be involved in the neurodegenerative processes underlying MSA.

“These early PET imaging findings provide quantitative evidence supporting the biological activity of intranasal foralumab in patients with MSA,” said Tarun Singhal, MBBS, M.D., Founding Director, NeuroPET Program, Ann Romney Center for Neurologic Diseases, Brigham and Women’s Hospital, Mass General Brigham. “In the first two MSA patients we evaluated, we observed up to approximately 35% reduction in standardized uptake value and a 24% reduction in SUV ratio in the affected brain regions. We focused on the most severely affected, clinically relevant areas known to be involved in MSA. Based on the available data, these appear to be robust quantitative findings and are comparable to results previously observed in patients with multiple sclerosis treated with intranasal foralumab, although there are methodological differences.”

“This is the third indication that we have seen a marked reduction in inflammation on PET scans following treatment with intranasal foralumab,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. “Building on the encouraging results previously reported in non-active secondary progressive multiple sclerosis and moderate Alzheimer’s disease, these initial MSA data further highlight the potential of our therapy to meaningfully address neuroinflammation across multiple neurodegenerative conditions with high unmet need.”

PET imaging comparisons conducted before and after treatment demonstrated marked reductions in radiotracer uptake across several disease-relevant brain regions. These findings suggest a reduction in neuroinflammatory activity following administration of intranasal foralumab.

Intranasal foralumab is a fully human anti-CD3 monoclonal antibody designed to modulate the immune system through mucosal tolerance mechanisms and reduce inflammation without the systemic toxicities associated with traditional anti-CD3 therapies.

MSA is a rare, progressive neurodegenerative disorder characterized by autonomic dysfunction, parkinsonism, and cerebellar ataxia. There are currently no approved disease-modifying treatments for the condition.

Tiziana plans to continue evaluating intranasal foralumab in additional patients to further validate these early findings and better characterize the therapy’s potential to reduce neuroinflammation in MSA.

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

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/99d6ad08-520b-4053-84a7-6a378f6a1aca
https://www.globenewswire.com/NewsRoom/AttachmentNg/83d9b57c-86b4-4051-9cb7-ebf80d6722d3
https://www.globenewswire.com/NewsRoom/AttachmentNg/82c2bf70-ed4a-4ea3-859b-65f97f65bad2

FAQ

What did Tiziana (TLSA) announce on May 14, 2026 about intranasal foralumab in MSA?

Tiziana announced initial Phase 2 PET imaging data showing reduced brain inflammation markers in two Multiple System Atrophy patients treated with intranasal foralumab. According to Tiziana, PET scans indicated measurable declines in radiotracer uptake in several disease-relevant brain regions after treatment.

How much did brain inflammation markers decrease in TLSA’s Phase 2 MSA trial with intranasal foralumab?

In the first two MSA patients, investigators observed up to approximately 35% reduction in standardized uptake value and about 24% reduction in SUV ratio. According to Tiziana, these quantitative PET changes occurred in clinically relevant brain regions affected by Multiple System Atrophy.

Which brain regions showed PET signal reductions in Tiziana’s intranasal foralumab MSA study?

PET imaging showed reductions in inflammatory activity in regions including the basal ganglia and cerebellar white matter. According to Tiziana, these areas are known to be involved in the neurodegenerative processes underlying Multiple System Atrophy and were a focus of the quantitative analysis.

Why are the intranasal foralumab MSA results important for TLSA investors?

The results provide early quantitative imaging evidence of reduced neuroinflammatory activity in MSA, a disease with no approved disease-modifying treatments. According to Tiziana, this is the third indication where intranasal foralumab has shown PET inflammation reductions, potentially broadening its neurodegenerative disease opportunity.

How do the MSA PET findings compare to prior intranasal foralumab data in multiple sclerosis and Alzheimer’s?

The MSA PET changes are described as comparable to earlier multiple sclerosis results, acknowledging methodological differences. According to Tiziana, intranasal foralumab has now shown marked PET inflammation reductions in non-active secondary progressive multiple sclerosis, moderate Alzheimer’s disease, and Multiple System Atrophy.

What are the next steps for TLSA’s intranasal foralumab program in Multiple System Atrophy?

Tiziana plans to continue enrolling and evaluating additional MSA patients in the ongoing Phase 2 trial. According to Tiziana, further data will help validate these early PET findings and better define intranasal foralumab’s potential to reduce neuroinflammation in Multiple System Atrophy.

What is intranasal foralumab and how is it intended to work in MSA?

Intranasal foralumab is a fully human anti-CD3 monoclonal antibody designed as an immune modulator. According to Tiziana, it aims to induce mucosal tolerance and reduce inflammation without the systemic toxicities typically associated with traditional anti-CD3 therapies in neurodegenerative conditions like Multiple System Atrophy.