Tiziana Life Sciences Doses First Patient in Phase 2 Alzheimer’s Clinical Trial

Rhea-AI Summary

Tiziana Life Sciences (Nasdaq: TLSA) announced that the first patient was dosed on December 17, 2025 in its randomized, placebo-controlled Phase 2 trial of intranasal foralumab for early Alzheimer’s disease.

The trial will evaluate foralumab as monotherapy and combined with FDA-approved anti-amyloid therapies lecanemab (Leqembi) or donanemab, and is supported by TSPO-PET imaging data showing persistent microglial activation after amyloid reduction. The program tests an immunomodulatory approach targeting residual neuroinflammation with intranasal anti-CD3 foralumab; enrollment will continue and clinical outcomes are pending.

Positive

• First Phase 2 patient dosed on December 17, 2025
• Trial tests foralumab alone and with lecanemab/donanemab
• TSPO-PET data supports target: persistent microglial activation

Negative

• No efficacy or safety results available; outcomes pending
• Phase 2 readouts required before commercial or regulatory impact

Key Figures

Trial phase Phase 2 Randomized, placebo-controlled early Alzheimer’s trial

First patient 1 patient dosed Initial dosing in Phase 2 Alzheimer’s trial

Anti-amyloid backbones 2 therapies Combination arms with lecanemab or donanemab

Announcement date Dec 17, 2025 Press release publication date

Market Reality Check

$1.60 Last Close

Volume Volume 252,306 is about 0.6x the 20-day average of 418,075 ahead of this news. low

Technical Shares at $1.55 are trading below the 200-day MA of $1.64 and 40.38% under the 52-week high.

Peers on Argus 1 Up 1 Down

Peer moves are mixed: KYTX in scanner down 17.48%, VOR up 4.93%, while watchlist peers like SLS (+8.37%) and TRDA (+2.9%) show no clear sector-wide pattern.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 15	Insider share purchase	Positive	-10.7%	CEO increased open‑market holdings by <b>163,400</b> TLSA shares.
Dec 15	Financing decision	Neutral	-10.7%	Company withdrew proposed public offering citing market conditions.
Dec 12	Alzheimer’s trial start	Positive	+3.5%	Enrollment began for Phase 2 early Alzheimer’s trial of intranasal foralumab.
Dec 02	Asset spinout plan	Neutral	+0.0%	Plan to spin out IL‑6 asset TZLS‑501 into a separate listed company.
Nov 25	ALS trial program	Positive	+5.2%	ALS Phase 2 foralumab trial accepted into Healey ALS MyMatch Program.

Pattern Detected

Clinical-trial updates for foralumab have often coincided with positive single-day moves, while recent corporate/financing news saw weakness.

Recent Company History

Over the last few months, Tiziana has repeatedly highlighted progress for intranasal foralumab. Clinical updates on multiple sclerosis, ALS, and early Alzheimer’s, including TSPO-PET imaging results, were followed by single-day gains up to 12.93%. In contrast, a CEO open‑market share purchase and withdrawal of a proposed offering on Dec 15, 2025 coincided with a -10.67% move. Today’s first‑patient dosing in the Alzheimer’s Phase 2 trial continues this clinical‑execution narrative.

Market Pulse Summary

The stock moved -5.8% in the session following this news. A negative reaction despite a clear clinical milestone would fit prior instances where corporate or financing headlines overshadowed fundamentals, as seen on Dec 15, 2025 with a -10.67% move. While historical clinical-trial news averaged moves near 8.54%, setbacks in capital markets or risk appetite can dominate. Sustainability of any decline may depend on future Alzheimer’s data flow and overall biotech sector tone.

Key Terms

intranasal medical

"First Patient Dosed with Intranasal Foralumab in Randomized..."

Administration or delivery of a drug or vaccine through the nose, typically via a spray or drops that are absorbed by the nasal tissues. For investors, intranasal products can matter because they often offer easier, needle-free use, faster onset of effect, and potential cost or compliance advantages that can widen a product’s market and affect regulatory review, manufacturing complexity, and commercial prospects — similar to how a convenient app can outsell a clunky desktop program.

foralumab medical

"its lead development candidate, intranasal foralumab, a fully human..."

Foralumab is an experimental biologic drug that targets a specific protein on immune T cells to dial down excessive immune responses; think of it like a thermostat that calms an overactive immune system. It has been tested by inhaled or nasal delivery in studies for autoimmune and inflammatory neurological conditions, and matters to investors because clinical trial results, safety profile, and regulatory progress determine its potential market value and licensing or partnership opportunities.

monoclonal antibody medical

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

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.

TSPO-PET medical

"The trial is supported by TSPO-PET imaging data demonstrating..."

TSPO-PET is a medical imaging technique that uses a radioactive tracer and a PET scanner to highlight the translocator protein (TSPO), a marker that tends to increase where inflammation or immune activity is present in the brain or other tissues. For investors, TSPO-PET matters because it can serve as an objective readout of whether a drug changes disease-related inflammation, like a thermometer showing if a treatment is cooling a fever, and thus can de‑risk clinical development, support regulatory claims, and influence trial enrollment and valuation.

microglial activation medical

"data demonstrating persistent and widespread microglial activation—a hallmark..."

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.

neuroinflammation medical

"a hallmark of neuroinflammation—in Alzheimer’s patients, even after..."

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.

anti-amyloid therapies medical

"in combination with FDA-approved anti-amyloid therapies, lecanemab..."

Anti-amyloid therapies are drugs or medical treatments designed to reduce, remove, or prevent buildup of abnormal amyloid protein in the brain, a hallmark of conditions like Alzheimer’s disease. Investors watch them because successful therapies can reshape markets and company valuations—think of clearing plaque from a pipe to restore function—while trial results, safety findings, regulatory approval, and insurance coverage determine commercial success and financial risk.

biomarkers medical

"Baseline cognitive testing, fluid biomarkers and TSPO-PET imaging..."

Biomarkers are measurable indicators found in the body, such as substances in blood or tissues, that reveal information about health or disease. For investors, they can signal how well a medical treatment is working or whether a disease is developing, helping to assess the potential success or risks of healthcare companies or innovations. Think of biomarkers as biological signals that provide clues about a person’s health status.

AI-generated analysis. Not financial advice.

• First Patient Dosed with Intranasal Foralumab in Randomized, Placebo-Controlled Phase 2 Trial
• Builds on Recent Evidence of Persistent Neuroinflammation in Alzheimer’s Patients Treated with Anti-Amyloid Therapies

BOSTON, Dec. 17, 2025 (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, announces that the first patient has been dosed with intranasal foralumab in its Phase 2 randomized, placebo-controlled clinical trial in patients with early Alzheimer’s disease (AD). This milestone follows the Company’s December 12, 2025 announcement that enrolment had begun and the first patient was expected to be dosed imminently. The Phase 2 trial evaluates intranasal foralumab both as monotherapy and in combination with FDA-approved anti-amyloid therapies, lecanemab (Leqembi®) or donanemab, in patients with early AD.

The trial is supported by TSPO-PET imaging data demonstrating persistent and widespread microglial activation—a hallmark of neuroinflammation—in Alzheimer’s patients, even after amyloid plaque reduction with lecanemab. This evidence underscores the need for therapies targeting residual neuroinflammation, which intranasal foralumab is designed to address by modulating immune responses and calming activated microglia.

Gabriele Cerrone, Chairman & Founder of Tiziana Life Sciences stated, “Dosing the first patient marks a pivotal moment in exploring a novel immunomodulatory approach to Alzheimer’s disease. Our prior TSPO-PET data in multiple sclerosis patients showed that intranasal foralumab can significantly reduce microglial activation, and we are eager to evaluate its potential impact—alone or combined with anti-amyloid treatments—in slowing disease progression in early AD.”

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented, “We are thrilled to have rapidly advanced from enrolment to first patient dosing in this important Phase 2 trial. This achievement reflects the dedication of our team and clinical sites, as well as the urgent need for new treatment strategies that go beyond amyloid clearance to target chronic neuroinflammation. We look forward to continuing enrolment and generating data that could redefine disease modification in Alzheimer’s disease.”

About the Phase 2 Trial

The Phase 2 study is a randomized, placebo-controlled trial assessing the safety, tolerability, and potential efficacy of intranasal foralumab as monotherapy and in combination with lecanemab or donanemab in early/mild Alzheimer’s disease. Primary endpoints include neuroinflammation measured by TSPO-PET imaging, cognitive function, and changes in amyloid and tau biomarkers. Interim data are anticipated in 2026, with results intended to guide future development and potentially establish neuroimmune modulation as a key pillar in AD therapy.

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. 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 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

Certain statements made in this announcement are 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 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, 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. 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

What did Tiziana (TLSA) announce on December 17, 2025?

Tiziana announced the first patient dosing in its Phase 2 intranasal foralumab trial for early Alzheimer’s disease.

How is the TLSA Phase 2 trial foralumab designed?

The randomized, placebo-controlled Phase 2 trial tests intranasal foralumab as monotherapy and combined with lecanemab or donanemab in early AD.

Why is Tiziana combining foralumab with Leqembi or donanemab in TLSA’s trial?

The combination addresses residual neuroinflammation shown by TSPO-PET evidence of persistent microglial activation after amyloid reduction.

What immediate impact does the TLSA first-patient dosing have for investors?

First-patient dosing advances the program into active Phase 2 execution, but no clinical efficacy or safety data are yet available.

When will investors expect results from Tiziana’s (TLSA) Phase 2 foralumab trial?

The company stated enrolment will continue; specific timing for readouts was not provided and outcomes remain pending.