Tiziana Life Sciences Ltd (NASDAQ: TLSA) began enrolling participants in a Phase 2, randomized, placebo‑controlled trial of intranasal foralumab for early Alzheimer’s disease on December 12, 2025. The study will assess foralumab alone and in combination with FDA‑approved anti‑amyloid agents lecanemab or donanemab.
Baseline assessments—including cognitive testing, fluid biomarkers, and TSPO‑PET imaging—have been completed for the first screened participants, and the company expects the first patient to receive the first dose next week. The trial’s primary endpoints focus on neuroinflammation reduction, cognitive outcomes, and amyloid‑ and tau‑related biomarkers.
This enrollment milestone could provide the data needed to advance foralumab toward regulatory approval and open partnership opportunities. It also validates Tiziana’s intranasal delivery platform, a unique differentiator that may improve efficacy and tolerability compared with intravenous delivery.
Tiziana remains a clinical‑stage biotech with a history of net losses: a half‑year 2024 net loss of $4.65 million versus $8.62 million a year earlier, and a full‑year 2024 loss of $11.9 million. No new financial guidance was issued, underscoring the company’s focus on R&D investment and milestone‑driven funding.
Dr. Howard Weiner, Chairman of Tiziana’s Scientific Advisory Board, said the trial “demonstrates the platform’s potential to address the persistent neuroinflammation that remains after amyloid clearance, a key driver of disease progression.”
On the day of the announcement, TLSA’s stock gained 3.49 % (and 1.74 % in a second report), reflecting investor enthusiasm for the de‑risking event. Analysts noted the trial as a significant step toward a broader therapeutic portfolio and potential commercial partnerships.
Several analysts have upgraded the stock to a “Buy” rating, citing the trial’s potential to unlock a new therapeutic pathway and the company’s strong intranasal delivery technology. The $8.00 price target reflects expectations of future growth once clinical data are available.
The Phase 2 enrollment marks a pivotal moment for Tiziana Life Sciences. Investors will closely monitor the trial’s safety, tolerability, and efficacy data, which could reshape the company’s trajectory and open new avenues for collaboration and commercialization.
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