Tiziana Life Sciences presented an overview of their transformational immunotherapy platform enabling alternative routes of administration. Their proprietary technologies allow for oral, nasal, and inhalation delivery of antibodies, which currently require IV administration. They highlighted clinical progress including trials of their lead asset foralumab administered intranasally for progressive MS and COVID-19. Results demonstrated safety and positive clinical responses. Tiziana is also developing other pipeline assets and expanding their management team and scientific advisory board.

1. NASDAQ: TLSA
www.tizianalifesciences.com
Corporate Presentation
October 2021
Transformational Platform Enabling Alternative Routes for Immunotherapy

2. 2
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3. 3
Tiziana Platform Enables Oral, Nasal and Inhalation
Administration of Antibodies
Most Antibodies Require IV
Administration Currently
• Costly and burdensome
• Systemic treatment requires
higher doses causing toxicity
To facilitate
local action
To maximize
efficacy/
toxicity ratio
To improve
patient
compliance
To reduce
cost
Proprietary Technologies
platform enables…
Oral
Nasal
Inhalation
• Phase 1b trial with ‘Take Home’ capsules of
foralumab for Crohn’s Disease
• Trial to begin shortly in US and EU
• Initiated Phase 1b under individual access program
(IPA) in MS patient with nasal administration of
foralumab
• Completed exploratory trial with nasally administered
foralumab in Covid-19 patients showing encouraging
results to move forward to the next trial
• Phase 2 trial in COVID-19 to begin shortly
• Developed proprietary formulation technology for
inhalation delivery of anti-IL-6 receptor mAb
• Completed safety/toxicity study in monkeys. Results
demonstrate treatments were well-tolerated
Most Antibodies Require IV
Administration Currently

4. 4
Major Updates
• Clinical stage biotechnology company developing allogeneic CAR-T for treatment of cancers
with its novel proprietary ARCUS® genome editing technologies
• The collaboration is to evaluate foralumab in conjunction with allogeneic CAR-T cells to
improve safety and long-term success
Collaboration
with Precision
Biosciences
Clinical
Updates
Intellectual
Property
• Dr. Neil Graham, MBBS, MD, MPH. CMO
• Dr. Kevin Schutz, Pharm D. VP Regulatory Affairs
• Dr. Venkat Renukuntla, MBBS. Assoc Director
Expansion of
Management
Team
• Five patents were granted in 2020/21
• Several patent applications are pending
• Completed 4 clinical studies with positive clinical results:
‒ Two Phase 1 trials with oral and nasal administration of Foralumab
‒ Phase 2 trial with Milciclib in sorafenib-resistant HCC (Liver cancer)
‒ Exploratory trial with nasal administration of foralumab in COVID-19 patients in Brazil
• Ongoing/next clinical studies
‒ The IPA Multiple Sclerosis trial ongoing. Patient completed 3 months of dosing with nasally administered
foralumab without any apparent symptoms of toxicity. Next study to start in Q1, 2022
‒ Phase 2 trial with nasal administration of foralumab in hospitalized COVID-19 patients in Brazil to start
in Q1, 2022

5. 5
Pre-clinical IND Phase 1 Phase 2 Phase 3
Foralumab
(TZLS-401)
fully human
anti-CD3 mAb
Lung Disease
Milciclib + Gemcitabine in Relapse/Refractory Solid Tumors
KRAS+ NSCLC (Milciclib + Gemcitabine)
Intranasal for Progressive Multiple Sclerosis (IPA)
Enteric Coated Oral Capsules for Crohn’s Disease
Intranasal for COVID-19
TZLS-501
fully human
anti-IL-6
receptor mAb
Milciclib
(TZLS-201)
pan-CDK
inhibitor
Ongoing
TBD
Completed
(Initiating next Phase 2 trial shortly)
IND submission 4Q, 2021
Completed
HCC monotherapy in Sorafenib Resistant Patients Completed
Initiation of Phase 2a trial
Q1 2022
Pipeline

6. 6
Willy Simon
Non-Executive Director
• Co-founder, EVP & CSO of Synergy Pharmaceuticals,
NASDAQ: SGYP
• Inventor of antibody oral formulation technology and pioneer
of GC-C agonist technology
• Inventor of TRULANCE® approved for Chronic constipation
and IBS-C. Dolcantide successfully completed Phase 2 trial
• Prior experience at Callisto Pharmaceuticals and Monsanto
Kunwar Shailubhai
PhD, MBA
CEO & CSO
Executive Director
Gabriele Cerrone
MBA
Executive Chairman
Neil Graham
MBBS, MD, MPH
CMO
Tom Adams
PhD
Executive Director
Executive Team
Management Team Has Proven Industry Leadership and Successful Track Record in Independently Bringing 4 Drugs to Market
• Expert in Medicines development and Infectious Diseases
Epidemiologist
• Global Development Expertise in Clinical Development and
in Medical Affairs
• Prior experience at Regeneron, Vertex, Trimeris Inc, XTL
Biopharmaceuticals, Glaxo Welcome.
• Over 35 years experience in pharma/biotech/
medical companies
• Led the development of onvansertib, for treatment of
KRAS-mutated metastatic colorectal cancer (mCRC)
• Prior Experience at Cardiff Oncology, Hepion
Pharmaceuticals, Clearbrige Biophotonics and Synergy.
• Founder and chairman of two biotech companies with
market cap over $2B
• Inhibitex sale for $2.5B
• Prior experience at Synergy, Trovagene, Gensignia, Rasna,
Contravir, and Siga Technologies
• MBA, Stern School of Business, NY, US.
• Career as an executive in the banking and corporate
finance sector and director of publicly listed companies
• Kredietbank N.V., Citibank, Generale Bank NL,
CEO of Fortis Investment Management
• Chairman 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 companies
• Management and SEC reporting
• Private and public fundraising experience
John Brancaccio
Non-Executive Director

7. 7
Kevan Herold
MD
Tanuja Chitnis
MD
• Professor of Neurology at Harvard Med
• Director and Founder of the Partners MS Center and
Co-Director of the Ann Romney Center for
Neurologic Diseases
• Pioneered investigation of the mucosal immune system
for the treatment of autoimmune and other diseases
Howard Weiner
MD
Chairman, SAC
Napoleone Ferrara
MD
Arun Sanyal
MD
Scientific Advisory Committee
• Professor of Immunobiology and Medicine and Deputy
Director, Yale Center for Clinical Investigation
• Director of the Yale Diabetes Center and Director of the
TrialNet Center at Yale
• Expert in autoimmune diseases and anti-CD3 monoclonal
antibody therapies
• Charles Caravati Distinguished Professor and Chair,
Division of Gastroenterology, Hepatology and Nutrition at
Virginia Commonwealth University School of Medicine
• Leader in the field of liver diseases
• Inventor of Avastin® ($6.67Bn/yr)*; 2010 Lasker Award
• Senior Deputy Director Basic Sciences,
Moores Cancer Center, UC San Diego
• Distinguished Prof of Pathology, School of Medicine,
UC San Diego
World renowned scientists with proven track records in drug discovery and development
• Professor of Neurology at Harvard Medical School.
• Senior Scientist at the Ann Romney Center for Neurologic
Diseases at Brigham and Women’s Hospital (BWH)
• Board-certified neurologist specializing in multiple sclerosis
(MS) related neuro-immunological disorders and leads
several research studies and clinical trials in these areas

8. Foralumab
The only fully human anti-CD3
monoclonal antibody in clinical studies

9. 9
OKT3
Muromonab*
ChAglyCD3
Otelixizumab
hOKT3γ1
(Ala-Ala)
Teplizumab
Nuvion
Visilizumab
Foralumab
IgG2a
IgG1
N297/A
IgG2
L234/A, L235A
IgG2
L234/A, V237/A
IgG1
L234/A, V335E
Fully Mouse
Chimeric &
Humanized
Humanized Humanized Fully Human
Oral and Nasal Administration
Market Opportunities
Foralumab is the Only Fully Human Anti-CD3 mAb
in Clinical Trials
CD3-specific Monoclonal Antibodies in Clinical Development
Adapted from: Kuhn, Chantal, and Howard L. Weiner. "Therapeutic anti-CD3 monoclonal antibodies: from bench to bedside." Immunotherapy 8.8 (2016): 889-906.
*Approved by the FDA for
solid organ transplantation
immuno-suppression
First Ever Patent Granted for Oral Immunotherapy
Oral Formulation Patent Granted in 2020
Nasal and SC Formulation Pending
Current Focus
IBD
MS
Current
Focus
CAR-T
NASH
RA
PSORIASIS
LUPUS

10. 10
Collaboration with Precision Biosciences on use of Foralumab in
Conjunction with their CAR-T Candidates for Cancer Treatment
Cy/Flu: cyclophosphamide/fludarabine
• 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 with CAR-T to enhance long-term
success in cancer treatment
• TLSA executed an agreement with Precision Bio (NASDAQ:DTIL) for use of foralumab in
conjunction with their allogeneic CAR-T for cancer treatment of cancer
- Upfront payments
- Multiple milestone payments for success
- Royalty for commercialized product
- Separate royalties for subsequent CAR-T products

11. Nasally
administered
foralumab is safe
and elicits clinical
responses

12. 12
Blood Brain Barrier
Tregs
Intranasal Administration of Foralumab Can Suppress
Inflammatory Signaling in the Brain
Nasal delivery of anti-CD3 activates mucosal immunity, stimulating Tregs that can cross BBB
Mucosal Immunity
Activation
Cervical
Lymph Node
Systemic
Circulation
Anti-inflammation
Stimulated Tregs can pass through the BBB to suppress the inflammatory signaling that drives
neurodegenerative diseases such as MS, Alzheimer's and ALS
Conventional Administration
(IV/Oral/SC)
Nasal Administration of Foralumab
Site targeted
immunomodulation
Lamina
propria
of
nasal
mucosa
Tregs
Tregs go
through lymph
node

13. 13
Nasally Administered Anti-CD3 mAb Effective in the Suppression
of MS in Animal Studies
Work completed by Prof. Howard Weiner
Mayo, Lior, et al. "IL-10-dependent Tr1 cells attenuate astrocyte activation and ameliorate chronic central nervous system inflammation." Brain 139.7 (2016): 1939-1957.
Progressive EAE Naive
60
40
20
0
IC aCD3
150
100
50
0
IC aCD3
Lesions Number Time on Rotarod
Nasal IC Nasal aCD3
Nasally administered
anti-CD3 stimulates
mucosal immunity
in cervical lymph node
Nasal IC Nasal aCD3
Spinal cords
Immunomodulation in nasal mucosa/cervical lymph node leads to
suppression of inflammation in spinal cords of EAE mice

14. 14
Phase I Trial with Nasally Administered Foralumab Completed
Demonstrating Safety and Positive Clinical Responses
Treated for 5 consecutive days using a
hand-held spray device
(6 active and 3 placebo patients in each dose level)
Dose-ranging,
double-blind,
placebo-controlled
study in healthy
subjects
10µg
50µg
250µg
0 1 2 3 4 5
• Treatment well tolerated
• No systemic absorption
• Data indicated positive clinical responses
• Downregulation of cytotoxic
CD8 cells and IFN-gamma.
• Upregulation of Tregs
1
2

15. 15
Individual Patient Expanded Access (IPA) Clinical Study in MS
The first patient has safely completed 3 months of dosing; No apparent
safety issues so far
Collected data are being analysed for safety tolerability and PK of nasally
administered foralumab. Clinical responses are encouraging.
The next follow up trial is being planned
A similar clinical study with nasally administered foralumab in Europe is
being explored
FDA allowed us to conduct a trial under individual access program to
evaluate nasally administered foralumab with dosing regimen (3 times/wk
for 3 months).

16. 16
Nasal Administration of Foralumab in Mild to Moderate COVID-19
The First Validation That Nasally Administered Foralumab
is Well-tolerated and the Treatment Provides Clinical Benefits
Cohort
(evaluable patients)
Lung CT Scan
(% Improvement)
Cytokine IL-6
(% Reduction)
C-Reactive Protein
(% Reduction)
Control (n=14) 43 37 40
Foralumab + Dexa (n=12) 75 41 55
Foralumab (n=10) 80 69 85
Hospital Visit
-2 0 1 3 5 13
10
*Eligibility
Confirmation Foralumab treatment + PRO survey
Dexa
Consent
Randomization
Blood Collection
Swab Collection Medical
Exam* CT Scan
Blood Collection Blood Collection
Hospital Visit
Medical Exam*
CT Scan
Day
End of
Treatment
Results
CT Scan of Patients Lungs

17. Orally administered
anti-CD3 mAb is safe
and produces clinical
responses
Oral formulation of foralumab to facilitate local action

18. 18
Orally Administered Anti-CD3 mAbs Have Been Clinically
Validated in Ulcerative Colitis
* 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, A. K., Weiner, H. L., Korzenik, J. R., Snapper, S. B. Immunologic alterations associated with oral delivery of anti-CD3
(OKT3) monoclonal antibodies in patients with moderate-to-severe ulcerative colitis. Crohn's & Colitis 360 (2019). 183: 240-246.
Biologic 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
1
2
3
• Oral administration of anti-CD3 mAbs has been clinically
validated in patients with inflammatory bowel disease
• Investigator initiated trial by Dr. Scott Snapper at Harvard
• Patients with moderate-to-severe ulcerative colitis received oral OKT3
Key Findings

19. 19
Orally Administered Foralumab in Phase 1b for Crohn’s Disease
Next Clinical Trial
• Phase 1b trial with ‘Take Home’ oral capsules in patients with Crohn’s Disease
• Open label adaptive design with dosing of 0.5, 1.25. 2.5 and 5.0 mg for 14 days.
• Primary endpoint: Safety and tolerability
• Secondary end points: mucosal healing, PK, ADA and biomarkers for assessment of clinical responses and MOA
• If treatment is well-tolerated then start Phase 2 trial
Intravenous
vs. Capsule

20. Milciclib
A Pan-CDK Inhibitor
(Most Potent for CDK2 (nM)
Milciclib
Src
Family
Kinases
CDK7
CDK2 CDK4
CDK5
CDK1

21. 21
Milciclib (TZLS-201) is an orally-bioavailable small molecule pan-CDK inhibitor in Phase II
development for solid tumor indications, including HCC and NSCLC
The treatment was well-tolerated in a total of 316 patients with solid cancers
• Improved toxicity profile over the current standard of care
Demonstrated clinical responses in patients with following cancers
• Phase 2 trials in Thymoma and Thymic Carcinoma.
• Refractory solid malignancies (NSCLC, prostate, pancreatic etc.).
• Sorafenib resistant advanced patients with HCC.
Complex heterogeneity in HCC and NSCLC due to multiple etiological agents;
Need for broad-spectrum approach
• Strong positive clinical responses in HCC
Milciclib well-tolerated with manageable side effects in patients with refractory solid tumors
An Oral Drug Candidate with Remarkable Safety and Clinical
Responses in Cancer Patients

22. 22
22
Small Molecule PAN-CDK Inhibitor
Milciclib May Be Used to Treat Heterogenous Cancers
CDKs
Milciclib
IC50 (nM)
Palbociclib
IC50 (nM)
CDK2 45 >10,000
CDK4 160 9–11
CDK5 265 >10,000
CDK6 ND 16
CDK7 150 ND
Overexpression of CDK2 is Often the Escape Pathway for Development of Chemoresistance
• Complex heterogeneity in HCC and NSCLC due to multiple
etiological agents; Need for broad-spectrum approach
• Milciclib is more potent inhibitor of CDK2, an essential
enzyme for cell cycle regulation and often a target for
development of chemoresistance
• Inhibits multiple signaling pathways that are underlying
hepatocarcinogenesis. Specifically downregulates
miR-221/miR-222 pair and c-myc
• The treatment was well-tolerated in a total of 316 patients
with solid cancers
• Improved toxicity profile over the current standard of care

23. 23
Phase 1 Study of Milciclib + Gemcitabine
in Refractory Solid Tumors
Swimmerplot showing treatment duration. 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
• Milciclib was well-tolerated with manageable
side effects
• Overall response rate was 36%
• Clinical activity was observed in patients who
were non-responders to all standard therapy
• Recommended Phase 2 dose (RPD) found
to be 80mg/m2/day
Results
• 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)
Trial Design Activity in NSCLC
Next Trial in KRAS+ NSCLC Patients is Being Planned

24. 24
Milciclib Phase 2a Trial in Sorafenib-resistant HCC
The Phase 2 Clinical Data with Milciclib in Sorafenib Resistant HCC Patients Were Presented At ASCO 2020
PFS – progression free survival
ORR – Objective response rate
TTP – Time to progression
• Dosing: Oral 100 mg/day,
consecutive 4 days a week
in a 4-week cycle for
6 months
Trial Design
• Population: 30 sorafenib-resistant
HCC patients
• Primary end point: Safety
• Secondary end points:
PFS, ORR & TTP
• Exploratory: AFP and miRNA profiling
Next trial with combination of Milciclib with a
TKI patients in Asian countries is being explored
Combo patent granted in 2020
(full freedom to use milciclib in combination
with other drugs including immunotherapies)
Status: Complete with 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
Major Clinical Endpoints
Treatment was
well-tolerated and
adverse events were
manageable with
no drug related
deaths in the trial
Median time
to progression
was
5.9 months
Stabilized
Disease
(SD):
57%
Clinical
Benefit
Response:
61%

25. 25
• HCC is a complex and heterogenous cancer
associated with multiple etiological factors that
may benefit from a broad-spectrum approach
A Combination Approach Inhibiting Multiple Pathways Might Be
Essential to Efficiently Treat HCC and NSCLC
Hepatocellular Carcinoma: Etiology and Current and Future Drugs
Jindal A., Palejwala V., and Shailubhai, K.
Hepatitis C
Hepatitis B
NASH
(Non-alcoholic steatohepatitis)
• NSCLC is a complex and heterogenous cancer with
multiple genetic mutations
• K-RAS and EGFR mutations predominate in NSCLC
Cirrhosis
(any etiology)
Alcohol
Anabolic Steroids
Aflatoxins Hemochromatosis
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%
G12C
G12V
G12D
G12A
J. Clin. Exp. Hepatol. (2019) 9 (2) 221-232

26. 26
Upcoming Milestones and Catalysts
• Submission of IND and initiation of phase 1a trial with TZLS-501 Q1, 2022
in healthy volunteers
• Initiation of Phase 2 trial in KRAS+ NSCLC patients with combination Q1, 2022
of Milciclib with Gemcitabine
• Initiation of Phase 1b trial with orally administered foralumab in Q1, 2022
patients with Crohn’s disease
• Clinical data with nasally administered foralumab in MS patient Q2, 2022
under the IPA programClinical data from
• Phase 2 Clinical data with nasally administered foralumab in Q2, 2022
hospitalized COVID-19 patients in Brazil

27. US Headquarters
Tiziana Therapeutics Inc
3805 Old Easton RD
Doylestown, PA 18902-8400
+ 1 (267) 982 9785
mpreiss@tizianalifesciences.com
UK Headquarters
Tiziana Life Sciences plc
55 Park Lane
London W1K 1NA
United Kingdom
+44 7769 88 4020
hmalik@tizianalifesciences.com
Contact Us