(Nasdaq: TLSA) Profile

October 14, 2023

OUR NEW PROFILE IS:

(NASDAQ: TLSA)

READ THE INVESTOR PRESENTATION HERE

Great News Today: Tiziana Announces Positive Qualitative Six-Month PET Scan Results With Intranasal Foralumab Treating Multiple Sclerosis Patients Diagnosed With Non-Active Secondary Progressive MS #MSMilan2023 @ECTRIMS @ACTRIMS $TLSA #MultipleSclerosis https://t.co/Bw3Vc7vCWY pic.twitter.com/ESQyGU6jL9
— TizianaLifeSciences (@TizianaLS) October 13, 2023

HELLO EVERYONE,

We have a new profile for Monday’s session.

This is another company that we have never looked at before on this newsletter before.

Pull up TLSA right away.

Historically, monoclonal antibodies, such as blockbuster drug, Humira®, have performed as the best selling drugs in the world. Targeting across multi-indications such as autoimmune disorders and degenerative diseases, these drugs have multi-billion dollar blockbuster potential.

To this day, there is no drug on the market that is a fully human, anti-CD3 monoclonal antibody…and Tiziana Life Sciences (NASDAQ: TLSA) is developing the potential to treat patients in need that suffer from secondary progressive multiple sclerosis.

Tiziana Life Sciences (NASDAQ: TLSA) is a clinical stage biotechnology company that specializes in developing transformative therapies for neurodegenerative and lung diseases. The Company’s clinical pipeline includes drug assets for Secondary Progressive Multiple Sclerosis, ALS, Alzheimer’s, Crohn’s Disease and KRAS+ NSCLC.

Tiziana is led by a team of highly qualified executives with extensive drug development and commercialization experience.The Company is developing transformational formulation technologies, enabling it to switch from traditional routes to alternative routes of immunotherapy to facilitate local sites of action.

INVESTMENT HIGHLIGHTS:

A revolutionary platform: TLSA is first in class, switching from uncomfortable antibody injections to revolutionary nasal and oral methods of delivery. The benefits of switching to this unique methodology are increased patient compliance, minimized side effects, and anticipated lower cost of goods and administration.

Multiple Indications: TLSA’s focus is across multiple indications such as neurodegenerative diseases like Multiple Sclerosis as well as lung diseases. Similar monoclonal antibody drugs, such as Humira®, have performed extraordinarily well with approximately $200 billion dollars in revenue.

Monoclonal Antibodies: Recently, Provention Bio, a competitor for TLSA, was acquired by Sanofi SA (NASDAQ: SNY) for $2.9 billion. Tiziana stands out from the competition as their drug, foralumab, is administered nasally and is fully human.

Foralumab: Tiziana’s clinical drug, foralumab, a fully human anti-CD3 monoclonal antibody for the treatment of neurodegenerative diseases, works with novel technology to be delivered nasally. This allows the drug to bypass and potentially prevent the toxicities that may be present with non-fully human antibodies making it a revolutionary and very exciting clinical development.

Market Potential: Neurodegenerative diseases are rising which contributes to a growing market market projected to reach USD 53 Billion by 2030 and grow steadily at a CAGR of 3.2%. Beyond that, competitors are catching the attention of big pharma.

Unmet Need: TLSA is dedicated to developing drugs to service diseases that currently have no cure. The company’s clinical trial is across multiple neurodegenerative disease, autoimmune, and lung disease indications.

FORALUMAB (TZLS-401)

Foralumab is a fully human anti-CD3 monoclonal antibody (mAb) for the treatment of Crohn’ s and neurodegenerative diseases. We have completed two Phase 1 clinical trials: one for progressive MS indication with nasal administration and the other for Crohn’s disease indication, with enteric coated capsules administered orally. We also completed a Phase 2 trial treating mild to moderate non-hospitalized COVID-19 patients in Brazil with intranasal foralumab with positive results (Moreira et al., 2021)*. Currently, two secondary progressive MS patients are being treated at Brigham and Women’s Hospital, Boston MA, with intranasal foralumab under Expanded Access INDs with signs of clinical benefit, we are expecting 12-month data from EA#1 and 6-month data from EA#2 in 4Q-2022. Patient enrolment for the Intermediate-size patient population expanded program has begun. Foralumab has demonstrated ability to activate regulatory T cells that systemically circulate to elicit targeted immunomodulation providing therapeutic benefit to patients.

Tiziana has recently submitted a patent application on potential use of Foralumab, to improve success of chimeric antigen receptor T cells (CAR-T) therapy for cancer and other human diseases. The patent application covers inventions related to improving CAR-T expansion and/or survival. Foralumab administered alone or co-administered in combination with co-stimulatory molecules, such as an anti-IL-6 receptor monoclonal antibody, an anti-CD28 monoclonal antibody or specific inhibitors of signalling pathways of phosphatidylinositol 3-kinase (PI3K), protein kinase B (AKT), or mammalian target to improve success of CAR-T therapy.

* Moreira, T. G., et al. (2021) Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study. Front Immunol 12, 709861

MILCICLIB (TZLS-201)

Milciclib is a potent, small molecule inhibitor of multiple cyclin-dependent kinases (CDKs), tropomycinreceptor kinases and Src family kinases controlling cell growth and malignant progression of cancer. Milciclib has demonstrated safety and tolerability in 316 patients with advanced solid cancers in Phase 1 and 2 studies and also exhibited positive clinical responses. In two, successfully completed, Phase 2 thymic cancer trials, Milciclib successfully increased overall survival and met both primary and secondary endpoints.

In July and September 2019, we reported positive Phase 2a safety, tolerability and efficacy data of Milciclib as a monotherapy in 28 patients with advanced HCC. The results, presented at ASCO2020, warrants further clinical development. Strong genetic and pharmacological evidence suggests that pan-CDKs inhibitors might have potential to suppress the multiple tumorigenic pathways that are activated due to activation of KRAS gene. Clinical data from a Phase I dose-escalation study with combination of milciclib with gemcitabine showed significant disease stabilization and suggested that milciclib can reverse gemcitabine-resistance in NSCLC refractory solid tumors. The clinical response in the NSCLC patient was particularly very promising. Company is exploring the combination of milciclib and gemcitabine in NSCLC subjects with pan KRAS-positive mutations.

TZLS-501

Tiziana’s Anti IL-6R mAb (TZLS-501), a fully human mAb binds to both membrane-bound and soluble forms of IL-6R, an inflammatory cytokine driving chronic inflammation associated with autoimmune disease and cancer, reducing circulating levels of the IL-6 cytokine. Anti-IL-6R antibody can potentially be used in combination with Foralumab or other anti-inflammatory and anti-infective agents as therapy for idiopathic pulmonary fibrosis (IPF), acute respiratory distress syndrome (ARDS), multiple myeloma, arthritis, lupus and oncology indications. Excessive production of IL-6 is regarded as a key driver of chronic inflammation and is believed to be associated with severe lung damage and chronic fibrosis observed with acute and chronic respiratory illness.

The Company is scaling GMP manufacturing of its anti-IL-6R mAb concurrently with developing a hand-held nebulizer technology for direct delivery of the antibody into the for treatment of patients with IPF, a rare disease indication.

TIZIANA ANNOUNCES POSITIVE QUALITATIVE SIX-MONTH PET SCAN RESULTS WITH INTRANASAL FORALUMAB TREATING MULTIPLE SCLEROSIS PATIENTS DIAGNOSED WITH NON-ACTIVE SECONDARY PROGRESSIVE MS (NA-SPMS)

OCT 13, 2023 7:00AM EDT

Five out of six patients in FDA authorized Expanded Access Program are showing a qualitative reduction in microglia activation (a key biomarker being observed)
Foralumab to advance into Phase 2 human clinical trials using the world’s only fully human intranasal anti-CD3 monoclonal antibody
Phase 2 trial screening for na-SPMS to begin in November 2023

NEW YORK, Oct. 13, 2023 (GLOBE NEWSWIRE) — 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 a reduction in activated microglia, as seen in six-month Positron Emission Tomography (PET) scans, has now been observed in a total of five of the six patients with non-active secondary-progressive multiple sclerosis (na-SPMS) treated with intranasal foralumab in its Expanded Access Program (EAP). Activated microglia are believed to play a prominent role in the pathogenesis of neuroinflammatory and neurodegenerative diseases including multiple sclerosis, Alzheimer’s disease, and amyotrophic lateral sclerosis, or ALS.

Tarun Singhal, M.B.B.S., M.D., Director of the PET Imaging Program in Neurologic Diseases, associate neurologist and nuclear medicine physician at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, and Assistant Professor of Neurology at Harvard Medical School, commented, “Upon review of the baseline and six-month PET scans of the latest cohort of four Expanded Access patients, three out of the four scans suggested a qualitative reduction in the microglial PET signal. When combined with my assessment of the first two Expanded Access patients at six-months, five of the six suggested a reduction in qualitative microglial PET signal. An example of this can be seen in the graphic below, titled, “Figure 1”, showing the deactivation of this signal in patient EA6. This is promising from an imaging standpoint, and further studies are needed to confirm these findings using additional quantitative approaches.”

Howard L. Weiner, M.D., Chairman of Tiziana’s Scientific Advisory Board and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital added, “With six patients now dosed in our na-SPMS EA program, I feel that Dr. Singhal’s readout of the six-month PET scans strongly supports our previously announced 3-month clinical findings.”

PUBLISHED

AUG 17, 2023

TIZIANA LIFE SCIENCES ANNOUNCES LIVE BLOOMBERG TV INTERVIEW OF RENOWNED SCIENTIST DR. HOWARD L. WEINER TO DISCUSS FDA IND CLEARANCE FOR INTRANASAL FORALUMAB IN ALZHEIMER’S DISEASE

PUBLISHED

AUG 15, 2023

TIZIANA LIFE SCIENCES GETS FDA GREEN LIGHT TO INVESTIGATE POTENTIAL ALZHEIMER’S TREATMENT

MANAGEMENT TEAM

GABRIELE CERRONE

Executive ChairmanMr Cerrone has a successful track record and extensive experience in the financing and restructuring of micro-cap biotechnology companies. He has founded nine biotechnology companies in oncology, infectious diseases and molecular diagnostics, and has taken six of these companies to the NASDAQ Market and one to the AIM Market in London. Mr Cerrone co-founded Trovagene, Inc. (NASDAQ: TROV), a molecular diagnostic company and served as its Co-Chairman; he was a co-founder and served as Chairman of both Synergy Pharmaceuticals, Inc. (NASDAQ: SGYP) and Callisto Pharmaceuticals, Inc. (OTCMKTS: CLSP), and was a Director of and led the restructuring of Siga Technologies, Inc. (NASDAQ: SIGA). Mr Cerrone also co-founded FermaVir Pharmaceuticals, Inc. and served as Chairman of the Board until its merger in September 2007 with Inhibitex, Inc. Mr Cerrone served as a director of Inhibitex, Inc. until its US$2.5bn sale to Bristol Myers Squibb Co in 2012. Mr Cerrone is the Executive Chairman and Co-Founder of Gensignia Life Sciences, Inc., a molecular diagnostics company focused on oncology using microRNA technology; Chairman and Founder of Tiziana Life Sciences plc (AIM: TILS) an oncology focused therapeutics company; Chairman and Co-Founder of Rasna Therapeutics Limited, a company focused on the development of therapeutics for leukaemias; Co-Founder of ContraVir Pharmaceuticals, Inc. (Nasdaq: CTRV); and founder of BioVitas Capital Ltd.

MATTHEW W DAVIS, MD, RPH

Chief Medical Officer and acting Chief Scientific OfficerDr. Davis has extensive experience in new drug application, or NDA, and biologic license application, or BLA, FDA approvals and device clearances. Notable approved brands that Dr. Davis has worked on include Lidoderm®, Sculptra®, Colcrys® and most recently QWO®. Dr. Davis previously served as Chief Scientific Officer and Chief Medical Officer at Endo Pharmaceuticals where he restructured the R&D department and collaborated to obtain BLA approval for QWO®. Additionally, Dr. Davis was Chief Medical Officer for Lupin Inc. and URL Pharma, Inc. where he spearheaded three NDA approvals and was the inventor on all 17 Orange Book listed patents for Colcrys®. He also was on the executive team that sold URL Pharma to Takeda Pharmaceutical Company for approximately $800M combined with over $1B in performance-based contingent earn out payments. Dr. Davis matriculated to the University of Pennsylvania as an undergraduate. He received his Pharmacy Degree from Temple University and his Medical Degree from the Medical College of Pennsylvania. Dr. Davis undertook his surgical training at Brown University and his Urology training at Washington Hospital Center

KEEREN SHAH

Chief Financial OfficerKeeren Shah serves as our Chief Financial Officer. Ms. Shah currently also serves as the Chief Financial Officer of OKYO Pharma Ltd, Accustem Sciences Limited and Rasna Therapeutics Inc., having previously served as the Group Financial Controller for all businesses from June 2016 to July 2020. Prior to joining the Company, Ms. Shah spent 10 years at Visa, Inc. as a Senior Leader in its finance team where she was responsible for key financial controller activities, financial planning and analysis, and core processes as well as leading and participating in key transformation programmes and Visa Inc.’s initial public offering. Before joining Visa, Ms. Shah also held a variety of finance positions at other leading companies including Arthur Andersen and BBC Worldwide. She holds a Bachelor of arts with honors in Economics and is a member of the Chartered Institute of Management Accountants.

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