Tiziana Life Sciences Announces FDA Allowance for Additional Twenty Patients to be Enrolled in the Intranasal Foralumab Multiple Sclerosis Expanded Access Program

Tiziana Life Sciences Announces FDA Allowance

for Additional Twenty Patients to be Enrolled in the Intranasal Foralumab Multiple Sclerosis Expanded Access Program

NEW YORK, April 23, 2024 - Tiziana Life Sciences, Ltd. (Nasdaq:

TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies

via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has allowed its intranasal foralumab

non-active Secondary Progressive Multiple Sclerosis (na-SPMS) Expanded Access (EA) Program to expand from 10 patients to a total of 30

To date, of the 10 participating patients, two patients have been dosed

for more than one year and eight additional patients have been dosed for six months, all without serious side effects. All patients have

either stabilized or improved on treatment with foralumab, and no patients have declined in key clinical measures. Additionally, 70% of

these patients have seen a measurable improvement in fatigue. These data are the first to combine PET imaging with a novel ligand, immune-biomarkers,

clinical measures and comprehensive safety data endpoints in patients receiving long-term intranasal foralumab. In November 2023 Tiziana

initiated a Phase 2a trial in na-SPMS. Patients not eligible for the Phase 2a trial may now be considered for this expanded EA program.

The September 2023 release of FDA guidance entitled "Guidance

on Substantial and Confirmatory Evidence of Efficacy and Safety" addresses the use of EA programs to be considered as part of confirmatory

evidence. As per FDA guidance, "Expanded access refers to the use of an investigational drug when the primary purpose is to diagnose,

monitor, or treat a patient's disease or condition rather than to obtain the kind of information about the drug that is generally

derived from clinical trials."

Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life

Sciences commented, "Tiziana is glad to provide patients with na-SPMS who do not qualify to be enrolled on our Phase 2 trial (NCT06292923)

the possibility to receive open-label treatment with our intranasal fully human anti-CD3 monoclonal-antibody, foralumab. As there are

no FDA approved treatments for na-SPMS, an EA program gives these patients access to this novel drug."

"I am grateful to be allowed to dose 20 additional patients that

do not meet the inclusion criteria for the ongoing intranasal foralumab Phase 2a, randomized, double-blind placebo-controlled, multicenter

dose-ranging study multiple sclerosis trial potential access to this treatment," stated Dr. Tanuja Chitnis, M.D., Professor of Neurology

at Harvard Medical School and senior neurologist at Brigham and Women's Hospital, a founding member of Mass General Brigham Healthcare

System. "The EA program has allowed us to obtain important information about dosing, and drug use, including patient feedback which

was critical for the design of the current Phase 2a trial."

Activated T cells play an important role in the inflammatory process.

Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating

T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients

with COVID and with multiple sclerosis, as well as in healthy normal subjects. The na-SPMS intranasal foralumab Phase 2 trial began screening

patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for 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 nasal 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, 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.

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, 2022, 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

LifeSci Advisors, LLC