TLSA (Tiziana Life Sciences Ltd.) stock: $0.69, $87.7M market cap, $3.7M cash, $84.3M EV, $69.8M fully diluted market cap. Lead program: Foralumab TZLS-401 100 µg (Non-Active Secondary Progressive Multiple Sclerosis), Phase 2. Data from Fully Diluted's biotech stocks database.
What they do
We subsequently changed our name to Tiziana Life Sciences plc in April 2014 as a result of the acquisition of Tiziana Pharma Limited in April 2014. On August 20, 2021 we announced that we had formally commenced a strategic plan to change our corporate structure by establishing Tiziana Life Sciences Ltd, a Bermuda-incorporated company, to become the ultimate parent company of the Tiziana Group.
Primary: Safety/tolerability and change from baseline in microglial activation measured by [18F]PBR06 TSPO PET imaging (Phase 2a INFORM-MS, 12 weeks of intranasal foralumab in non-active secondary progressive multiple sclerosis) — Trial met its dual primary endpoints: globally normalized white matter SUVR adjusted treatment difference -0.0231 (95% CI -0.0416 to -0.0046) at the 50 ug dose versus placebo, p=0.0168; no statistically significant PET difference at the 100 ug dose
· Modified Fatigue Impact Scale total score mean change -6.17 in the 50 ug arm (p=0.035 vs own baseline) and -7.18 in the 100 ug arm (p=0.040), compared with -3.12 in the placebo arm
· 48 participants randomized: placebo n=18, foralumab 50 ug n=19, foralumab 100 ug n=11; PET-analyzable n=40
· No changes seen in the EDSS secondary endpoint over the 3-month treatment duration
· Treatment-emergent adverse events in 15/18 (83.3%) of placebo patients and 23/30 (76.7%) of foralumab-treated patients; most common were headache, fall, nasal congestion, and rhinorrhea
· All 48 participants completed treatment
Safety: Well tolerated at both doses; no deaths, no discontinuations due to adverse events, and no study-drug related serious adverse events
ALS (Amyotrophic Lateral Sclerosis); ALS - Amyotrophic Lateral Sclerosis; ALS
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Estimated readout windows: registry primary-completion date + 6-12 weeks. Windows already open are shown from "Now". Drug names link to ClinicalTrials.gov.
Dementia; Alzheimers Disease; Mild Cognitive Impairment Due to Alzheimer's Disease
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Sponsor-matched active trials from ClinicalTrials.gov (4 as sponsor, 1 as collaborator); "Sponsor" = company is the lead sponsor, "Collaborator" = company is a collaborator. The BP column flags big-pharma involvement as lead sponsor or collaborator (excluding the company itself). The Mgmt guide column shows what management guided for readout timing when a guided program matches the trial (hover for the quote, click for the source). Trial listings are not a company pipeline slide.