Tiziana Life Sciences To File Alzheimer's IND For Intranasal Foralumab In Q2 2023

• Application for $3M of non-dilutive funding for Phase 2a Alzheimer’s trial will be submitted in Q2 2023
• Tiziana guided by FDA Type “B” meeting comments on its scheduled Q2 2023 intranasal foralumab Alzheimer’s IND filing
• Alzheimer’s patients will be administered 3-months of intranasal foralumab to study effects on neuroinflammation caused microglia activation

Tiziana Life Sciences Ltd. (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced its plan to submit an IND for intranasal foralumab in patients with mild to moderate Alzheimer’s Disease in Q2 2023.

“Following the FDA feedback from our protocol and development plans from the August 2022 type “B” Pre-IND meeting, Tiziana plans submit its intranasal foralumab protocol and IND for mild to moderate Alzheimer’s disease in Q2 2023,” stated Gabriele Cerrone, Executive Chairman, Founder and interim Chief Executive Officer of Tiziana. “Tiziana is also seeking $3,000,000 in non-dilutive funding from a prestigious Alzheimer’s foundation to support the Phase 2a trial. It is my expectation that this funding application will be submitted Q2 2023 with a response expected Q3 2023.”

“There are no FDA approved treatments for Alzheimer’s disease specific to the neuroinflammation caused microglia activation triggered by amyloid beta plaque,” commented Matthew W. Davis, M.D., RPh, Chief Medical Officer of Tiziana. “We plan to study 3-months administration of intranasal foralumab in Alzheimer’s disease patients to see if neuroinflammatory activated microglia will return to the baseline homeostatic state.”