Good Afternoon Market Enthusiast,

We’ve talked about Tiziana Life Sciences (NASDAQ: TLSA) before… and for good reason.

This is one of those rare biotech stories that keeps getting stronger the deeper you look! Now they’re back in the spotlight with fresh momentum, new funding, a broadened clinical pipeline, and a seat at global forums that are shaping the future of medicine.

And here’s the best part: the market still hasn’t fully caught on.

With new catalysts dropping—from a Department of Defense grant to a major scientific conference appearance to a second immunology program heating up—Tiziana isn’t just building a pipeline. They’re building a movement in neuroimmune medicine.

Let’s break down why we’re doubling down on this name… and why you might want to, too.

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🧬 1. A Breakthrough Platform That’s Showing Real Results (4)(5)(6)(7)

Tiziana’s lead program centers on intranasal foralumab, a fully human anti-CD3 monoclonal antibody delivered through the nose—a non-invasive route designed to induce immune regulation directly at the brain-immune interface. This isn’t a theoretical mechanism: it’s been tested in real patients, with results that are turning heads in the neurology space.

In a recent Expanded Access study focused on non-active Secondary Progressive Multiple Sclerosis (SPMS)—a condition with no currently approved treatments—foralumab showed zero disability progression across all participants over 6 months (100% EDSS stabilization). Even more encouraging, over half the participants reported fatigue improvement, a notoriously difficult symptom to address. PET imaging showed clear biological effects: significant reduction in microglial activation, the inflammatory footprint in the brain.

💡 No serious adverse events were reported.

A larger, double-blind Phase 2 trial is now underway, with topline data expected by the end of 2025. But Tiziana isn’t stopping there—Alzheimer’s and ALS trials using the same platform are already moving forward. The bet here is not just one condition, but a multi-disease strategy across neuroinflammation.

🧠 2. Elite Partners. Real Science. Big Backing. (4)(5)(6)(7)

The strength of Tiziana’s relationships says a lot about the science. Their SPMS trial is running at world-class institutions like Brigham & Women’s Hospital, Yale, Johns Hopkins, and UMass—centers that don’t partner lightly. These collaborations lend clinical credibility and executional firepower to the program.

The reach is expanding:
 

• The ALS Association is helping fund an upcoming ALS trial of foralumab—external capital and validation in one stroke.
• The company has also begun dosing Alzheimer’s patients under Expanded Access, while a $4 million NIH grant supports broader research into Foralumab in neurodegeneration.
• In a newly announced program, the U.S. Department of Defense has awarded a research grant to evaluate intranasal foralumab in spinal cord injury (SCI), further expanding its potential applications in neuroinflammation. (11)
   

This isn’t science in a silo—it’s a platform that’s capturing the attention of academia, regulators, advocacy groups, and now government research arms.

⚡ 3. Trials Moving Fast. FDA’s Paying Attention. (4)(5)(6)(7)

Tiziana’s programs aren’t just progressing—they’re accelerating with strong regulatory momentum and clinical clarity.

In non-active SPMS, the ongoing Phase 2a; blinded portion is targeted to complete by year-end 2025.

This follows compelling Expanded Access data showing 100% EDSS stabilization and marked reduction in neuroinflammation. The current trial includes biomarker-driven endpoints and is being run at elite medical centers, raising the stakes—and the credibility.

With IND clearance and early EA signals, Tiziana is advancing plans for a Phase 2 study. Supported by a $4 million NIH grant, this trial will evaluate foralumab in early symptomatic Alzheimer’s patients, measuring microglial activation and cognitive markers.

And for ALS, the company filed an IND in March 2025 to launch another Phase 2 trial. Funded in part by the ALS Association, the study will assess foralumab’s role in slowing disease biology over a six-month dosing window.

Most notably, foralumab received Fast Track designation from the FDA for SPMS, providing a path to faster review and increased regulatory dialogue. It’s a clear signal: agencies are aligned with the science, and doors are opening faster than usual.

Tiziana also continues to advance TZLS-501, a fully human anti-IL6R monoclonal antibody. While distinct from foralumab, it represents a second major asset in the company’s pipeline, targeting autoimmune and inflammatory diseases. (9)

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💼 4. Momentum Is Building—and Insiders Know It (4)(5)(6)(7)

TLSA shares have more than doubled year-to-date in 2025, reflecting growing recognition of what’s unfolding.

This isn’t just speculative buzz: in May, Tiziana’s Executive Chairman purchased 15,000 shares at $1.55, raising his ownership to around 37%.

🧩 That’s real alignment from someone who knows the inside story.

🔎 TL;DR — Here’s Why TLSA Deserves Your Focus Now

Tiziana Life Sciences is navigating the biotech landscape with something rare: clinical results, regulatory traction, institutional partnerships, financial prudence, and strong insider alignment.

Neuroinflammation is the common thread across some of the world’s most devastating diseases—MS, Alzheimer’s, ALS, and now spinal cord injury. If one therapeutic platform can show durable, safe, and disease-modifying effects across that spectrum, the implications are profound.

Tiziana is not chasing trends. They’re building the next chapter in neuroimmune medicine. And right now, they’re doing it with growing support, measured risk, and visible progress.

If you’re following real innovation with real stakes—keep your eyes on TLSA.

🧬

To your success,

Max Masters

Co-founder, Market Tips Newsletter

Sources:
1. https://finance.yahoo.com/quote/TLSA/
2. https://finance.yahoo.com/quote/TLSA/history/
3. https://www.tizianalifesciences.com/
4. https://www.tizianalifesciences.com/wp-content/uploads/2025/03/Tiziana-Neuro-Presentation-March-2025-Non-Confidential.pdf
5. https://www.tizianalifesciences.com/drug-pipeline/intranasal-foralumab/
6. https://bit.ly/43ZF1mS
7. https://bit.ly/43Z4mO2
8. https://www.tizianalifesciences.com/tiziana-life-sciences-invited-to-attend-life-sciences-innovation-forum-2025-in-riyadh-saudi-arabia/
9. https://www.tizianalifesciences.com/tiziana-to-advance-tzls-501-its-fully-human-il-6r-monoclonal-antibody/
10. https://www.tizianalifesciences.com/tiziana-life-sciences-announces-poster-presentation-on-intranasal-foralumab-clinical-trial-at-the-41st-ectrims-congress/
11. https://www.tizianalifesciences.com/department-of-defense-awards-grant-to-advance-tiziana-life-sciences-intranasal-anti-cd3-therapy-for-spinal-cord-injury/

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