Corporate PresentationTransformational Core Technologies Enabling Alternative Routes for Immunotherapy

November 2021

www.tizianalifesciences.com NASDAQ: TLSA

Disclaimer and Forward Looking Statement

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The content of this presentation has been prepared for the purpose of providing general information about, and an overview of, the Company and its business. It is not intended to be a complete review of all matters concerning the Company and nor has it been independently verified.Whilst the presentation has been prepared in good faith and the Company has taken all reasonable care to ensure the information and facts contained in this presentation are accurate and up-to-date, it does not make any representation or warranty, express or implied, as to the accuracy or completeness of any information included in this presentation. Neither the Company nor any of its directors, officers, employees or agents shall be liable for any loss arising directly or indirectly from the use of or reliance upon this presentation or in relation to the adequacy, accuracy, completeness or reasonableness of the information it contains. All and any such liability is expressly excluded to the fullest extent permitted by law. The information in this presentation is subject to updating, completion, revision, further verification and amendment without notice.

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Foralumab (T1 Diabetes)Submission of IND and initiation of Phase 1a trial in healthy volunteers

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Near Term Milestones

1Q-2022 Foralumab (nasal)Clinical data with nasally administered foralumab in secondary progressive multiple sclerosis (SPMS) under the individual patient access (IPA) program

1Q-2022 Milciclib 2Q-2022 Foralumab (nasal)Initiation of Phase 2 trial in KRAS+ NSCLC patients with combination of Milciclib with Gemcitabine

Phase 2 Clinical data with nasally administered foralumab in hospitalized COVID-19 patients in Brazil

1Q-2022 Foralumab (oral)Initiation of Phase 1b trial with orally administered foralumab in patients with Crohn’s disease

2Q-2022

Executive TeamManagement Team Has Proven Track Record in Independently Bringing 4 Drugs to Market

Co-founder, EVP & CSO of Synergy Pharmaceuticals, NASDAQ: SGYPInventor of antibody oral formulation technology. Pioneer of GC-C agonist technologyInventor of approved drug TRULANCE®. Dolcantide successfully completed Phase 2 trialPrior experience at Callisto Pharmaceuticals (NASDAQ: CLSP) and Monsanto

Founder and chairman of two biotech companies with market cap over $2BInhibitex sale for $2.5BPrior experience at Synergy, Trovagene, Gensignia, Rasna, Contravir, and Siga TechnologiesCo-founded NASDAQ: HEPH, CLSP, RASP, CRDF

Over 35 years experience inpharma/biotech/medical companiesLed the development of onvansertib, fortreatment of KRAS-mutated metastaticcolorectal cancer (mCRC)Prior Experience at Cardiff Oncology, Hepion Pharmaceuticals, Clearbrige Biophotonics and Synergy.

Kunwar Shailubhai PhD, MBACEO & CSOExecutive Director

GabrieleCerroneMBAExecutive Chairman

Tom AdamsPhDExecutive Director

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Career as an executive in the banking and corporate finance sector and director of publicly listed companiesKredietbank N.V., Citibank, Generale Bank NL, CEO of Fortis Investment ManagementChairman of Bank Oyens & van Eeghen, Partner at Redi & Partners

Over 35 years financial experience in pharma/biotech/medical devices with over 15 years experience with multiple public companiesManagement and SEC reportingPrivate and public fundraising experience

Expert in Medicines development and Infectious Diseases EpidemiologistGlobal Development Expertise in Clinical Development and in Medical AffairsPrior experience at Regeneron, Vertex, Trimeris Inc, XTL Biopharmaceuticals,Glaxo Welcome

Willy SimonNon-Executive Director

John BrancaccioNon-Executive Director

Neil GrahamMDChief Medical Officer

Scientific Advisory Committee

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World renowned scientists with proven track records in drug discovery and development

Foralumab / MS

Foralumab Foralumab / MS

Foralumab / T1D Foralumab / HCC & CD

Inhalation

Intranasal

FORALUMABFully Human anti-CD3 mAb

Systemic Administration Traditional for antibody treatments

are costly and burdensome

Systemic treatment requires higher doses causing toxicity

Drug level in blood is high during the first few hours after dosing

Localized ActionLower Required Dose Cost effectiveAnticipated Lower Tox & Superior EfficacySuperior patient’s compliance

Pioneering approach to switch from intravenous to potentially transformational alternative routes of immunotherapies

Oral

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ForalumabFully human Anti-CD3 mAb

Pipeline

MilciclibPan-CDK Inhibitor

Inhalation

Intranasal

Intranasal

Oral

Oral

Oral

Oral

PC IND Phase 1 Phase 2 Phase 3

Progressive Multiple Sclerosis (expanded program)

Covid-19

Enteric Coated Oral Capsules for Crohn’s Disease

TZLS-501Fully human Anti-IL-6 mAb

Lung Disease4Q, 2021IND submission

Completed

Completed

1Q-2022IND Submission

Ongoing

Phase 2 trial soon to start Following ANVISA approval

Completed (next trial being planned)

Milciclib + Gemcitabine in Refractory Solid Tumors

KRAS+ NSCLC (Milciclib + Gemcitabine)

HCC monotherapy in Sorafenib Resistant Patients

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Major Updates

Clinical Progress IP Progress

Five patents were granted in 2020/21

Several patent applications are pendingForalumab: Phase 1 oral

and nasal trials completed

Foralumab: Phase 1 trial with nasal administration in COVID-19 patients in Brazil completed

Milciclib: Phase 2 trial in sorafenib-resistant HCC (Liver cancer) completed

Ongoing clinical Studies

Foralumab: The individual access expanded program (IAP) trial with nasal administration in multiple sclerosis is ongoing.First patient completed 3 out of 6 months of dosing with nasally administered foralumab. No apparent toxicity symptoms.Data on clinical responses will be available in 2Q-2022

Foralumab: Phase 2 trial with nasal administration in hospitalized COVID-19 patients in Brazil to start by 1Q-2022

Tech Validation

Precision Bio Licensing (NASDAQ: DTIL)

Clinical stage biotechnology company dedicated to improving life with its novel proprietary ARCUS® genome editing company

Use of foralumab in conjunction with allogeneic CAR-T to improve long term success

Multiple milestone payments during the clinical development and royalties after commercialization

4 clinical studies completed. All with positive data

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ForalumabThe only fully human anti-CD3 monoclonal antibody in clinical studies

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OKT3Muromonab*

IgG2a

ChAglyCD3Otelixizumab

IgG1N297/A

(Ala-Ala)hOKT3γ1Teplizumab

IgG2L234/A, L235A

NuvionVisilizumab

IgG2L234/A, V237/A

Foralumab

IgG1L234/A, V335E

Fully MouseChimeric & Humanized Humanized Humanized Fully Human

10First Ever Patent Granted for Oral Immunotherapy

Adapted from: Kuhn, Chantal, and Howard L. Weiner. "Therapeutic anti-CD3 monoclonal antibodies: from bench to bedside." Immunotherapy 8.8 (2016): 889-906.

Oral Formulation Patent Granted in 2020 Nasal and SC Formulation Pending

Rodent Origin

*Approved by the FDA for solid organ transplantation

immuno-suppression

NASH

RA

Lupus

CAR-T

Psoriasis

CD3-specific Monoclonal Antibodies in Clinical Development

Market Opportunities

MSIBD T1D

Foralumab is the Only Fully Human Anti-CD3 mAb in Clinical Trials

Human Origin * Point Mutation

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Collaboration with Precision Biosciences on use of Foralumab in Conjunction with their CAR-T Candidates for Cancer Treatment

• Recurrence rates of cancer in patients treated with CAR-T without lymphodepletion is very high due to poor survival of CAR-T cells

• Currently, CAR-T is conducted with pre-conditioning with lymphodepletion agents (Cy/Flu) to improve survival of CAR-T cells in patients

• Cy/Flu treatment is highly toxic resulting in deaths of patients

• Foralumab is the only fully human anti-CD3 mAb that may have the potential to be used as safe lymphodepleting agent.

• TLSA patented the use of foralumab in conjunction withCAR-T to enhance long-term success of CAR-T for cancertreatment

TLSA executed an agreement with PrecisionBio (NASDAQ:DTIL) for use of foralumab inconjunction with their allogeneic CAR-T forcancer treatment of cancer.

Cy/Flu: cyclophosphamide/fludarabine

Upfront payments

Multiple milestone payments for success

Royalty for commercialized product

Separate royalties for subsequent CAR-T products

Intranasal

Treatment with nasally-administered foralumab for treatment of neurodegenerative diseases

Fully HumanAnti-CD3 mAb

BBBBlood-Brain-BarrierSite targeted immunomodulation

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Nasal administration with foralumab for neurodegenerative diseasesAn innovative approach to overcome blood brain barrier (BBB) inaccessibility

Fully HumanAnti-CD3 mAb

Cervical Lymph Node

BBBBlood-Brain-Barrier

Systemic Circulation Of Tregs

Cervical Lymph NodeDendritic Cell

Site targeted immunomodulation

Tregs

IgA+ B cellsCD4+ T cells

Mcells

Nasal Epithelium

Mucosa

IntranasalSingle Dose

BBB

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Mechanism of action validated in animal studies with nasally administered foralumab

Effective in suppressing symptoms of MS in animal studies

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40

20

150

100

50

0000

IC aCD3IC aCD3

No. of LesionsNasal IC

Progressive EAE Naive

Nasal aCD3 Time on RotarodDrug Collects in

lymph node

Work completed by Prof. Howard WeinerMayo, Lior, et al. "IL-10-dependent Tr1 cells attenuate astrocyte activation and ameliorate chronic central nervous system inflammation." Brain 139.7 (2016): 1939-1957.

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Downregulation Cytotoxic CD8 cells IFN-gamma

SafetyClinical Response

No Systemic Absorption Well-tolerated

Upregulation IL-10 TregsTregs are capable of crossing Blood Brain Barrier to elicit site targeted immunomodulation.This approach has the potential for the treatment of neurodegenerative diseases, such as; MS, Alzheimer's and ALS.

Phase 1 clinical trial with nasally administered foralumab showed no apparent toxicity symptoms

Healthy Subjects(6 active and 3 placebo patients in each dose level)

Treated for 5 consecutive days using a hand-held spray device

Dose-ranging double-blind

placebo-controlled

10µg

5 Days1 3 42

50µg

250µg

First clinical trial with nasally administered foralumab in COVID-19 patients in Brazil is completed.Phase 2 trial in hospitalized COVID-19 patients in Brazil to startby the end of 2021.

This is the firstclinical validation that nasally administered foralumab may act through normalizing the immune system.

Individual expanded access program ongoing and the first patienthas safely completed 3 months of dosing.

Dataare being analysed for safety tolerability,PK and clinical responses. Complete data will be available in Q2, 2022.

The next step for a dose ranging trial in secondary progressive multiple sclerosis (SPMS) patients is being planned.

A similar clinical study with nasally administered foralumab in Europe is being explored.

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Ongoing multiple sclerosis trial with nasally administered foralumab under the individual access program

Intranasal

Treatment of COVID-19 patients with nasally-administered foralumab

COVID-19

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Fully HumanAnti-CD3 mAb

The First Validation That Nasally Administered Foralumab is Well-tolerated and the Treatment Provides Clinical Benefits

CT Scan of Patients’ Lungs*EligibilityConfirmation

ResultsCohort Lung CT Scan Cytokine IL-6 C-Reactive

ProteinEvaluable patients % Improvement % Reduction % Reduction

Control, n=14 43 37 40Foralumab + Dexa, n=12 75 41 55

Foralumab, n=10 80 69 85

Nasal Administration of Foralumab: Mild to Moderate COVID-19

-2 DaysHospital Visit Dexa

Blood and Swab Collection Medical Exam *CT Scan

Blood Collection

Blood Collection

10 DaysEND of Treatment

13Hospital Visit Medical Exam*CT Scan

0 1 3 5

Foralumab treatment + Patient reported outcome

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Treatment with orally-administered foralumab for treatment of gastrointestinal diseases

Oral ‘Take Home’ capsulesForalumab, a fully human anti-CD3 mAb

Oral

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Oral

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Capsule taken orally

FORALUMABFully HumanAnti-CD3 mAb

Orally Administered Foralumab in Phase 1a in healthy volunteers

Clinical results

Single ascending dose, double-blind, placebo-controlled study in healthy subjects

Foralumab administered at 1.25, 2.5 and 5.0 mg/dose in enteric-coated capsules

Well-tolerated at all doses tested and no drug-related safety issues observed, including toxicities associated with IV administration of anti-CD3 mAb.

No systemic absorption of orally administered foralumab

* Boden, E. K., Canavan, J. B., Moran, C. J., McCann, K., Dunn, W. A., Farraye, F. A., Ananthakrishnan, A. N., Yajnik, V., Gandhi, R., Nguyen, D. D., Bhan, Aantibodies. K., Weiner, H. L., Korzenik, J. R., Snapper, S. B. Immunologic alterations associated with oral delivery of anti-CD3 (OKT3) monoclonal in patients with moderate-to-severe ulcerative colitis. Crohn's & Colitis 360 (2019). 183: 240-246.

Key FindingsBiologic response of increased proliferation and anti-inflammatory gene expression profile in peripheral blood mononuclear cells

3 of 6 patients had a clinical response including one patient in clinical remission

Treatment was well-tolerated with no serious treatment-related adverse events

Oral administration of anti-CD3 mAbs has been clinically validated in patients with inflammatory bowel diseaseInvestigator initiated trial by Dr. Scott Snapper at Harvard Medical SchoolPatients with moderate-to-severe ulcerative colitis received oral OKT3 once daily for 30 days

Orally Administered Anti-CD3 mAbs Have Been Clinically Validated in Ulcerative Colitis

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CDK5

Broad-Spectrum inhibitory activities of milciclib towards CDKs is well positioned for treatment of NSCLC and HCC

Milciclib

CDK2Inhibition

CDK1Inhibition

CDK5Inhibition

CDK4Inhibition

CDK7Inhibition

M

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Specifically downregulates miR-221/miR-222 pair and c-myc.

Cytoplasm

Milciclib Targets Multiple Pathways in HCC and NSCLC

HCC is a complex and heterogenous cancer associated with multiple etiological factors that may benefit from a broad-spectrum approach

Noha E. Ibrahim, Wael M. Aboulthana, Ram Kumar Sahu. Hepatocellular Carcinoma: Causes and Prevention. UKJPB. 2018; 6(5): 48-55.

Sholl, Lynette M., et al. "Multi-institutional oncogenic driver mutation analysis in lung adenocarcinoma: the lung cancer mutation consortium experience." Journal of thoracic oncology 10.5 (2015): 768-777.

• NSCLC is a complex and heterogenous cancer with multiple genetic mutations

• K-RAS and EGFR mutations predominate in NSCLC

KRAS Mutations: 30% of NSCLC

KRAS mutations correlated with:• Higher exonic mutation rate• Smoking genomic signature• STK11 mutation• P53 mutation

10 to 100-fold higher mutation rate than EGFR-mutated or KRAS wild-type tumours

42%21%

17%7%

G12CG12VG12DG12A

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Phase 1 Study of Milciclib + Gemcitabine in Refractory Solid Tumors

Trial Design

16 Patients with refractory solid tumors

Treated with oral milciclib at three dose levels(45, 60, and 80 mg/m2/day)

With a fixed dose of IV gemcitabine(1000 mg/m2/day)

ResultsMilciclib was well-tolerated with manageable side effects

Overall response rate was 36%Clinical activity was observed in patients with variety of solid cancers who were non-responders to all existing chemotherapy

Recommended Phase 2 dose (RPD) found to be 80mg/m2/daySwimmer plot showing treatmentduration. Tumor type was indicated for patients having a prolonged stable disease or a partial response. M Milciclib; G gemcitabine.

Cancer Chemotherapy and Pharmacology, June 2017, 79(6), 1257-1265

Phase 2 study with the same combination and dosing regimen in KRAS+ NSCLC will be initiated shortly

Phase 2 with milciclib in sorafenib-resistant hepatocellular demonstrated safety and clinical benefits of treatment

Next trial with combination of Milciclib with a TKI patients in Asian countries is being explored

DosingOral 100 mg/day, consecutive 4 days a week in a 4-week cycle for 6 months

Population30 sorafenib-resistant HCC patients

StatusCompleted. Data from 28 out of 31 evaluable

14 patients completed treatment as per protocol

Nine patients were approved for compassionate use.

Seven patients extended treatment until 9, 9, 10, 11, 13,13 and 16 months

Two patients completed 20 months

Tx Well ToleratedTreatment was well-tolerated and adverse events were manageable with no drug related deaths in the trial

TTP 5.9 monthsMedian Time-to-Progression

SD 61%Patients with stabilized disease

CBR 64%Patients showed clinical benefit response

The Phase 2 Clinical Data Were Presented At ASCO 2020

Trial Design Data, n = 31 Clinical Endpoints

Safety

Secondary PFS, ORR & TTPPFS – progression free survivalORR – Objective response rate TTP – Time

to progression

ExploratoryAFP and miRNA profiling

Primary

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Contact Us

US Headquarters Tiziana Life Sciences 3805 Old Easton RDDoylestown, PA18902-8400+ 1 (267) 982 9785

UK Headquarters Tiziana Life Sciences 55 Park Lane London W1K 1NA United Kingdom+44 7769 88 4020hmalik@tizianalifesciences.com

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