RBC Capital Markets Healthcare Conference February 23, … · and MDSC function in the TME ... 6001 3010 0008 4001 0019 4005 7009 1006 5008 6006 0004 0004 0003 1007 0011 5009 7002

RBC Capital Markets Healthcare Conference

February 23, 2016

Forward Looking Statements

Advaxis, Inc. (the “Company”) has filed a registration statement (including a prospectus)

and will file a preliminary prospectus supplement with the Securities and Exchange

Commission (“SEC”) for the offering to which this presentation relates. Before you

invest, you should read the prospectus and the preliminary prospectus supplement in

that registration statement and other documents the Company has filed with the SEC for

more complete information about the Company and the offering.

This presentation contains forward-looking statements, including, but not limited to:

statements regarding Advaxis' ability to develop the next generation of cancer

immunotherapies; and the safety and efficacy of Advaxis' proprietary immunotherapy,

axalimogene filolisbac. These forward-looking statements are subject to a number of

risks, including the risk factors set forth from time to time in Advaxis's SEC filings,

including but not limited to its report on Form 10-K for the fiscal year ended October 31,

2015, which is available at http://www.sec.gov.

Advaxis undertakes no obligation to publicly release the result of any revision to these

forward-looking statements, which may be made to reflect the events or circumstances

after the date hereof or to reflect the occurrence of unanticipated events, except as

required by law. You are cautioned not to place undue reliance on any forward-looking

statements.

2

Advaxis Overview

Background

• Core technology – live attenuated Listeria monocytogenes (Lm) bacterial vector

stimulates the immune system to view tumor cells as bacterial infected cells and

subsequently targets them for elimination

• Alters tumor microenvironment by increasing tumor fighting cells and decreasing

tumor protecting cells

• ~50 employees with lab, office, manufacturing facilities, and vivarium located in

Princeton, NJ

Financial Snapshot

• Raised ~$165M since October 2013

• Cash: ~$112M as of October 2015

Summary of Strengths

• Extremely versatile platform technology can be used to treat any type of cancer

through targeting driver mutations and/or neoepitopes

• Existing collaborations with Merck & Co., Inc. and AstraZeneca/MedImmune, LLC

• Straightforward and scalable manufacturing process with low COG

• Highly proprietary technology (80+ patents) with low royalty obligation (2.5%)

3

Key Value Drivers

Lm Technology™ Candidates in Development

• Axalimogene filolisbac (AXAL) – Comprehensive clinical development program in early and

late stage HPV-associated cancers

• ADXS-HER2 – Clinical development program in multiple HER2 expressing solid tumors

AT-014 for canine osteosarcoma anticipated launch in 2016 (licensed to Aratana/NASDAQ: PETX)

• ADXS-PSA – Clinical development program in metastatic castration-resistant prostate

cancer (mCRPC) as monotherapy and in combination with KEYTRUDA®

• Orphan Drug Designations for invasive cervical cancer, head and neck cancer, anal cancer,

and osteosarcoma

Preclinical Pipeline

• ADXS-NEO – Neoepitope-based immunotherapy targeting mutations identified in an

individual patient’s tumor using massive parallel sequencing; IND anticipated 2016

• ADXS-TNBC – Triple negative breast cancer; IND anticipated 2016

Combination with Other Cancer Therapies

• Synergistic response with checkpoint inhibitors (PD-1 and PD-L1) and costimulatory

molecules (OX40 and GITR) in preclinical models

• Enhanced response in combination with radiation in preclinical prostate cancer models

KEYTRUDA is a registered trademark of Merck & Co., Inc.

4

Lm Technology™ Overview: Harnessing Unique Life Cycle of Lm in APCs

Lm-LLO is

phagocytosed

by APC

Some Lm-LLO

escapes the

phagolysosome

and enters the

cytosol

Some Lm-LLO is killed

and degraded within the

phagolysosome

tLLO-TAA fusion

protein is degraded

by proteasomes into

peptides for

presentation to the

MHC class I pathway

Peptide-MHC

complexes on

the APC

simulate CD4+

(MHC II) and

CD8+ (MHC I)

T-cells

APC, antigen presenting cell; Lm, Listeria monocytogenes; MHC, major histocompatibility complex; TAA, tumor-associated antigen; tLLO, truncated listeriolysin O

Lm-LLO and Tumor Associated

Antigen (TAA) presented and

taken up by dendritic cells

(antigen presenting cells or

APCs)

Dendritic cells activated to

generate an immune response

through both the MHC I and

MHC II pathways

Robust T-cell response

generated toward antigen

secreted by Lm-LLO and

redirected against tumors

expressing the same TAA

"Perceived" acute infection

stimulates a strong innate

immune response through

multiple pathways

(e.g. STING)

Over-rides checkpoint

inhibitors and negative

regulators of cellular immunity

1

2

3

4

5

5

T-cells target TAA on

tumor cells and tLLO

causes inhibition of Treg

and MDSC function in

the TME, reducing the

tumor’s protective shield

TAA activates cytotoxic

T-cells targeted against the

tumor

Attenuated Lm trigger a

robust immune response

and bioengineered

plasmids generate a

fusion protein, tLLO-TAA

...so that cancer can be recognized ...and killed

APC, antigen presenting cell; Lm, Listeria monocytogenes; MHC, major histocompatibility complex; TCR, T-cell receptor; MDSC, myeloid-derived

suppressor cells; TAA, tumor-associated antigen; tLLO, truncated listeriolysin O; Treg, regulatory T cell; TME, tumor microenvironment

Lm Technology™ stimulates a tumor-targeted immune response

The Intelligent Immune Response

6

Active or Planned Clinical TrialsAxalimogene filolisbac, ADXS-PSA, and ADXS-HER2

PRODUCT INDICATION PHASE 1 PHASE 2 PHASE 3 Partner

Axalimogene

filolisbac

CERVICAL CANCER*

M

AIM2CERV – Adjuvant Randomized vs Placebo Phase 3

Metastatic – GOG 0265 Phase 2

Metastatic – Single Arm High Dose Phase 1/2

C Metastatic – Combo with durvalumab Phase 1/2

HEAD AND NECK CANCER*

M Neoadjuvant – Window of Opportunity - Mount Sinai Phase 2

ANAL CANCER*

M

RTOG – Adjuvant Randomized vs Control Phase 2/3

Adjuvant – Single Arm High Risk – Brown University (BrUOG) Phase 1/2

Metastatic (FAWCETT) Phase 2

ADXS-PSA

PROSTATE CANCER

C Metastatic – Combo with KEYTRUDA® (pembrolizumab) Phase 1/2

ADXS-HER2

HER2-POSITIVE SOLID TUMORS (INCLUDING OSTEOSARCOMA*)

M

Metastatic – Single Arm Phase 1

Osteosarcoma Phase 2

C Combination M Monotherapy Active Planned* Orphan Drug Designation

All trademarks and logos are the property of their respective owners.

7

Axalimogene Filolisbac: Open Label 2-Stage Phase 2 Study In Recurrent Cervical Cancer (GOG 0265)

AXAL Monotherapy

1x109 colony forming units (cfu) x 3

doses q 28 days (month 1, 2, 3) as an

80 ml infusion over 15 min

N = ~67 (Stage 1 and 2)

• Persistent or recurrent metastatic

cervical cancer (PRmCC)

• ≥ 1 prior chemotherapy regimen

for PRmCC, excluding that

received as a component of

primary treatment

• GOG PS 0/1

• Measurable disease ≥ 1 target

lesion (RECIST 1.1)

PRIMARY EFFICACY ENDPOINT: 12-MONTH SURVIVAL

Tewari KS, Monk BJ. CurrOncolRep. 2005; 7(6):419-34; GOG, Gynecologic Oncology Group

https://www.clinicaltrials.gov/ct2/show/NCT01266460

MONTH 1 MONTH 2 MONTH 3

Axalimogene

filolisbac

Day 0

Axalimogene

filolisbac

Day 28

Axalimogene

filolisbac

Day 56

8

Axalimogene Filolisbac: Open Label 2-Stage Phase 2 Study In Recurrent Cervical Cancer (GOG 0265)

• Study exceeded required 20.0% efficacy threshold and predetermined safety criteria

and has proceeded to Stage 2 with additional enrollment of 37 patients

• No approved therapy following failure of first-line treatment with historical survival only

4-7 months1

Safety Summary:

• Axalimogene filolisbac was well-tolerated, with Grade 1-2 fatigue, chills, and fever the

most commonly reported AEs; six patients experienced a treatment-related Grade 3 or

Grade 4 AE, which was considered possibly-related to axalimogene filolisbac. The

adverse events observed in the first stage of the study have been consistent with

those reported in other clinical trials with axalimogene filolisbac.

29 E

NR

OL

LE

D

3 did not

receive therapy

10 patients achieved required 12-month survival

12-month survival rate = 38.5% 26 treated

Stage 1 Data Presented at American Gynecological & Obstetrical Society (AGOS) 2015

1Monk BJ, et al. J Clin Oncol. 2009;27(7):1069-74.

9Presented by Thomas Herzog, MD, at AGOS 2015

GOG 0265: Stage 1 Final Data—Overall Survival

Among 18 (69%) patients who received all 3

per-protocol doses, median OS exceeded 1 year

(12.1 months) and 12-month survival was 55.6%

10

Presented by Thomas Herzog, MD, at AGOS 2015

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1-3

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11

Historical Perspective of 12-month Survival in GOG P2 Trials for Recurrent/Metastatic Cervical Cancer

GOG conducted numerous Phase 2,

single-arm, two stage studies in

recurrent persistent recurrent/metastatic

cervical cancer

The 12-month OS rate has never

exceeded 30%

38.5% of patients (n=10) treated with

AXAL achieved12-month survival,

exceeding historical rates in this

difficult to treat population

Avastin met the predefined criteria to

progress to the second stage of

enrollment (median OS = 7.3 mo and

12-mo OS = 30%)

GOG 0265 included a more heavily pre-

treated population than previous trials

and included post-progression CT and

Avastin patients

AXALAxalimogene

filolisbac

Presented by Thomas Herzog, MD, at AGOS 2015

Axalimogene Filolisbac: Randomized Phase 2 StudyTumor Response Data

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ADXS

ADXS/CIS

N=66 response-evaluable patients

LTS – Long Term Survivor

PD – Partial Disease

SD – Stable Disease

PR – Partial Response

CR – Complete Response

PD

PD

PDSD

SDSD SD SD SDSDSD SD SD SD PR PR

CR

CR

CR CR

LTS = alive > 18 months from randomization

Axalimogene filolisbac showed activity against

recurrent cervical cancer with and without

standard chemotherapy

3 doses of axalimogene filolisbac as

monotherapy produced CRs in a difficult to treat

patient population with few treatment options

12

Axalimogene Filolisbac: Next StepsPhase 3 AIM2CERV Study Schema

Patient characteristics:

High risk, locally advanced

cervical cancer

• FIGO stage I-II with

positive pelvic nodes

• FIGO stage III-IV

• Any FIGO stage with

para-aortic nodes

RANDOMIZATION 1:2 BETWEEN REFERENCE AND TREATMENT GROUPS

Cisplatin (at least 4 wks exposure) and

Radiation (minimum 40 Gy external beam radiation therapy)

Reference Group

Placebo IV Up to 1 yr

RANDOMIZE

Treatment Group

AXAL

(1 x 109 cfu) Up to 1 yr

Primary Endpoint: Progression Free Survival

13

Axalimogene Filolisbac + Mitomycin, 5-FU, & Radiation Open Label Phase 1/2 Study Anal Cancer (BrUOG*)

PRIMARY EFFICACY ENDPOINT: 6-MONTH CR-RATE

Axalimogene Filolisbac

1x109 cfu x 4 (1 prior to

chemoRT and 3 post, q 28

days) as a 500 ml infusion

over 30 min

• N = 25

• Primary stage II-III anal

cancer

• High risk of recurrence

• HPV-positive

6 WEEKS 28 DAYS 28 DAYS

Axalimogene

filolisbac #1

Day -10 to 14

6 weeks IMRT

Axalimogene

filolisbac #2

Day +10 post IMRT

Axalimogene

filolisbac #3

Axalimogene

filolisbac #4

BIOPSY BIOPSY

Follow

up

*BrUOG, Brown University Oncology Group; Perez K et al. IANS 2015; Abstract 23


Primary efficacy endpoint is 6-month CR-Rate, defined as the rate of clinical complete

response as determined by evaluation by proctoscopy at 6-months post-treatment

14

Axalimogene Filolisbac + Mitomycin, 5-FU, & Radiation Phase 1/2 Anal Cancer Study (BrUOG) Preliminary Data

Study open: April 2013

Accrual: N = 10 / 25 enrolled

Efficacy Summary:

• All patients who have completed

treatment achieved CR (N = 9)

• No evidence of recurrence

• Historical 3-year recurrence rate

in similar patient population =

~45%

• Follow-up duration:

0.5 months – 33 months

Safety Summary:

• Did not worsen the toxicity profile

of standard chemoradiation

• Chills, occasional rigors and flu-

like symptoms resolved prior to

leaving clinic (~2 hours)

Perez K et al. IANS 2015; Abstract 23.

TNM stage

0 200 400 600 800 1000 1200

T3N3 2

T2N2 3

T4N0 4

T3N3 5

T4N0 6

T2N0 7

T3N3 8

T3N0 9

T3N0 10

T4N3 11

Relapse Free Survival (Days)*

Relapse Free Survival (RFS)Follow-up duration 0.5—33 months

N = 10 treatment patients

On ADXS11-001 RFS

Patient expired unrelated to study treatment

Patient progressed systemically

*As of Jan 6, 2016

Note: Patient #1 enrolled but was never treated on study

Hx 3-yr RFS in

stage-matched

population

~45%

15

WEEK 1 WEEK 4 WEEK 7 WEEK 9REPEAT Q 12

WEEK CYCLES

• Persistent/recurrent, loco-regional or metastatic anal

cancer or HPV+ squamous cell carcinoma of the rectum

that are either treatment naïve in the metastatic setting or

have progressed/become intolerant to platinum therapy

• Axalimogene filolisbac monotherapy in Stage 1 at 1x1010

cfu in a “3+3” dose escalation design with interim analysis

• Axalimogene filolisbac + PD-L1 or PD-1 inhibitor in Stage

2 vs. SOC arm

• Proceed to Stage 2 if response rate >10% by either

RECIST 1.1 or irRECIST, or if 6-month progression free

survival (PFS) rate >25%

• Primary endpoints: Overall response rate, 6-month PFS,

and safety & tolerability

• Secondary endpoints: Duration of response, PFS, and

overall survival

Stage 1Axalimogene filolisbacDose level: Dose escalation to 1x1010 cfu

d1 wk 1,4,7,9 (1 cycle)

Cycles 2+ up to 2 years

N = 20

WEEK 1 WEEK 4 WEEK 7 WEEK 9REPEAT Q 12

WEEK CYCLES

AXAL AXALAXAL

Up to PD

or 2 years

Axalimogene Filolisbac + PD-L1/PD-1Initial Phase 2/3 Study in Anal Cancer: FAWCETT

Stage 2Axalimogene filolisbac + PD-L1/PD-1Dose level: 1x1010 cfu d1 wk 1,4,7,9 (1 cycle)

PD-L1/PD-1 d1 q 2wks

N = 40

AXAL Interim

Analysis

AXAL AXALAXAL AXAL Final Analysis

RR>10% or 6-month PFS>25%

1616

PD-L1/PD-1

Up to PD

or 2 years

SOC ArmCisplatin + 5-FU +/- radiationCisplatin 100 mg/m2 IV day 2

Continuous infusion 5-FU 1000 mg/m2/d IV days 1-5 (q 4 weeks)

N = 40

PD-L1/PD-1 PD-L1/PD-1 PD-L1/PD-1

Preclinical Rationale for Checkpoint Combination Trials AXAL + PD-1

Lm immunotherapy is synergistic with checkpoint inhibitors

HPV Tumor Model

Pe

rcen

t S

urv

iva

l

Days after tumor implantation

TC-1 tumor

implantation Tx 1 Tx 2

0 8

Days

15

Treatments:

Lm-LLO-E7: 5x106 cfu

CT-011 mAb: 50 μg

Data published in Journal for ImmunoTherapy of Cancer 2013, 1:15 doi:10.1186/2051-1426-1-15

17

Combination with anti-PD-L1 (durvalumab)Metastatic Cervical Cancer or Head & Neck Cancer

• HPV+ SCCHN or metastatic cervical cancer patients with

measurable disease and ECOG status 0-1

• Phase 1: dose confirmation safety run-in with 6 to 12 patients

receiving combination of AXAL fixed dose + durvalumab “3+3”

safety design; progress to expansion with 20 patients (HNSCC)

• Phase 2: Randomize 90 recurrent/metastatic cervical cancer

patients 1:1 onto durvalumab monotherapy or combination with

AXAL

• Following the completion of enrollment and the safety

evaluation of Cohort 1 in Phase 1 in 2015, the study

will complete enrollment of the expansion cohort in

the first half of 2016

• Phase 2 of the study will commence once dose

determination is made, with enrollment completed in

2016

Phase 1

AXAL + durvalumab

AXAL d1 wk 1,4,7 q12 wks + durvalumab d1 q 3wks

N = 6 to 12 with expansion to 20

Phase 2 (1:1 Randomization)

Durvalumab Monotherapy (N = 45)durvalumab d1 q 2wks

AXAL + durvalumab (N = 45)AXAL d1 wk 1,4,7 q12 wks + durvalumab RP2D

N = 90 Total

WEEK 1 WEEK 4 WEEK 7 REPEAT Q 12 WEEK CYCLES

Up to PD or 1 year

durvalumab durvalumab durvalumab

AXAL AXAL AXAL



AXAL AXAL AXAL


Up to PD or 1 year with

4 years surveillance

18






ADXS-PSA: Phase 1/2 Dose Escalation and Safety Study Alone and Combined with PD-1 (Keytruda®)

• N = 21 (Part A); N = 30 (Part B) [Total N = 51]

• Pretreated metastatic castration-resistant prostate

cancer (CRPC)

• No more than 3 prior systemic treatment regimens

with chemotherapy, hormonal, or immunotherapy

or more than 1 prior chemotherapeutic regimen in

the metastatic setting

• mTPI Design (Part A) to determine recommended Phase 2

dose

• Following the completion of enrollment and the safety

evaluation of ADXS-PSA in Part A, Part B combination arm

with Keytruda® will commence in the first half of 2016.

• Part B ADXS-PSA Dose = Part A recommended Phase 2

dose (DL-1) + Keytruda®

Part A

ADXS-PSA Monotherapy

Dose level 1: 1x109 cfu d1 wk 1,4,7 q12 wks



N = 21


ADXS-PSA ADXS-PSA ADXS-PSA

Part B

ADXS-PSA + Keytruda®

ADXS-PSA Part A Dose –DL1 d1 wk 1,4,7 q12 wks

Keytruda® 200 mg d1 q 3wks in 12 wk cycles

N = 30

https://clinicaltrials.gov/ct2/show/NCT02325557

Up to PD or

2 years


ADXS-PSA

Up to PD or

2 years

Keytruda® Keytruda® Keytruda®

ADXS-PSA ADXS-PSA

19

Checkpoint Inhibitor Market

20

1Webster RM. The immune checkpoint inhibitors: where are we now? Nature Reviews Drug Discovery 2014; 13: 883-884.2Insight Pharma Reports. Cancer Immunotherapy: immune checkpoint inhibitors, cancer vaccines, and adoptive T-cell therapies. Published 9/30/2014.

Immuno-oncology products are expected to

generate ~$9 billion across the world by 20222

The cancer therapeutic vaccines segment of

the market is expected to have sales of $1.2

billion2

Current immunotherapy products, such as the

checkpoint inhibitors, work by shutting down a

tumor’s ability to disrupt the immune system

and thereby allowing dormant T cells to

become active and attack the tumor

Rather than set up an indirect attack on cancer,

Advaxis products directly activate the immune

system to kill tumor cells

As a platform for immune activation, Advaxis’

Lm Technology is positioned to become the

“universal donor” of immuno-oncology, with

broad applicability as a combination therapy

across tumor types

# Dogs with Treatment Related Adverse Events (All toxicities reported are Grade 1) ADXS-HER2 and Overall Survival

ADXS-HER2 Dose 2x108 5x108 1x109 3x109 Total

Number of dogs recruited N=3 N=3 N=9 N=3 N=18

General Disorders

Pyrexia (>103) 2 1 5 2 10

Fatigue 1 1 7 2 11

GI Disorders

Vomiting 2 1 8 1 12

Nausea 2 1 9 2 14

Cardiovascular

Arrhythmias 0 1 1 1 3

Tachycardia 0 0 1 1 2

Hypotension 0 0 0 0 0

Hematological parameters

Thrombocytopenia 0 0 5 0 5

Biochemical parameters (increase)

γ-GT 0 2 0 0 2

Alkaline Phosphatase 1 1 4 1 7

ALT 1 1 1 0 3

AST 1 1 5 1 8

BUN 0 0 0 0 0

CREA 0 0 0 0 0

Cardiac Troponin I 0 0 1 0 1

Commercialization anticipated this year via licensee, Aratana Therapeutics

n=18

n=18p=0.011

n=18

ADXS-HER2Phase 1 Study in Canine Osteosarcoma: Safety & Efficacy

26

MST (days) 1 year survival 2 year survival

Vaccinated group 956 78% 67%

Historical control group 423 55% 28%

21

ADXS-HER2: Phase 1B Dose-Escalation Study in HER2 Expressing Solid Tumors

PRIMARY ENDPOINT: SAFETY AND RP2 DOSE

ADXS-HER2 Monotherapy

Dose level 1: 1x109 cfu q 3 wks



• N < 18 (Dose finding); N < 80

(Expansion phase) [Total N

~100]

• HER2-positive solid tumor (>1+

positivity in 1% of cells by IHC)

• Disease progressed or

intolerant to standard therapy

• ECOG PS 0-1

• 3+3 Phase I Design

PD, disease progression; RP2, Recommended phase 2

https://clinicaltrials.gov/ct2/show/NCT02386501

3 WEEKS 3 WEEKS 3 WEEKSUP TO PD

OR 2 YEARS

ADXS-HER2

Day 0

ADXS-HER2

Day 21

ADXS-HER2

Day 42If no DLT, next

Dose level initiates

Dose level 1 commenced with no DLTs to date

22

HIGHLY PERSONALIZED NEOEPITOPE-BASED CANCER IMMUNOTHERAPY

Targeting Neoepitopes Is the Next Step in the Evolution of Cancer Immunotherapy

Why does cancer develop “neoepitopes”?

• Tumors develop because of mutations in genes coding for key regulatory and functionalproteins

• Expression of mutated proteins causes aberrant cellular functions that result in malignancy,and malignant cells survive by avoiding the immune system

• Normal peptides are weakly immunogenic (central tolerance deletes high avidity clones), but mutated cancer proteins are completely different from normal cells (neoepitopes)

How can this be used to attack cancer?

• Immunotherapies work by “activating” the patient’s immune system to target epitopes in cancer cells

High avidity cytotoxic T-cells can be generated against neoepitopes

Checkpoint inhibition appears to work by enabling pre-existing T cells to respond against neoepitopes, expand, and become tumoricidal

Immunizing patients against their own neoepitopes with an attenuated live vector will generate or enhance T-cell responses against neoepitopes

• Because the T cell responses are only directed against the mutated neoepitopes, and there is no systemic blockade of tolerance, there should be no off-target toxicity and few AEs

24

Targeting Neoepitopes with Lm Technology™

Advantages for Personalized Immunotherapy

• tLLO—TAA fusion protein is a synthetic

peptide presenting multiple

neoepitopes secreted into the

cytoplasm of the APC

• 80-100 plasmid copies per bacteria

• Payload for 25-50 neoepitopes per

construct–up to ~2k+ amino acids

• Multiple constructs can be

administered for larger numbers of

neoepitopes

• Activates other immune pathways

(TLRs, PAMP, STING, DAMP, NOD1,

NOD2, CpG)

• Treatments can be given repeatedly

without neutralizing antibodies

• Generates strong innate and adaptive

T cell response, even to lower avidity

epitopes

• Decreases Tregs and MDSCs in the

tumor microenvironment

Lm Technology™ has advantages for targeting neoepitopes

Bandwidth—for example, 5 constructs can present >250 tumor neoepitopes to T-cells, obviating the need for a predictive algorithm

Feasibility—affordable and easy to manufacture in-time for patient treatment (compare to autologous therapy)

25

ADXS-NEO Start to Finish

How does it work?

Ship to patient’s institution

Multiple cycles of treatment and

combination with RT, PD-1,

co-stims possible

Academic or Commercial

Massively Parallel

Sequencing

Sequencing to identify non-

synonymous mutations

Identify neoepitopes

Advaxis designs vector based on

neoepitopes

Advaxis Immunotherapies

DNA synthesis – molecular cloning

into plasmids

Transfection into personalized

vector, QA/QC – OK

Patient’s Hospital or

Treating Institution

Treat patient with personalized

immunotherapy vector based on

his/her neoepitopes

Time from biopsy to infusion administration = ~6 weeks

26

ADXS-NEO: Next Steps

• Pre-IND meeting completed

• Planning to file IND in 2016

• Continue building collaborations to drive ADXS-NEO forward as rapidly as possible

• MINE™ Collaboration with Memorial Sloan Kettering Cancer Center will focus on preclinical and clinical development of neoepitope-based Lm treatments

• Completion of in-house manufacturing facility in 2016 to enable clinical supply

27

On-Site Manufacturing

Fully integrated in-house development, manufacturing, and testing to be

constructed in 2016

• Process development suite

• Solution preparation

• Inoculum preparation

• Bulk drug substance manufacturing

• Bulk drug product manufacturing

• Packaging

• NEO manufacturing

• QC labs

• Warehouse storage & distribution

Increased manufacturing capability and capacity will allow Advaxis to

manufacture its own material and reduce reliance on CMOs, improving

supply flexibility, scalability, lead times, and costs of goods

28

Financial Summary & Leadership Accountability

Cash Summary

Cash on hand as of

October 31st$112.2M

Capital raised since

October '13~$165M

No Debt

Equity Summary

Basic Shares

Outstanding 33.6M

Warrants and

Options3.2M and 2.0M

Fully Diluted 38.8M

29

Management voluntarily purchases restricted stock directly

from the Company every two weeks at market price

Out of Pocket Funds (1) Company Incentive Awards (1)

Gross $ net shares vested unvested

Daniel J. O'Connor $694,923 155,394 124,076 66,667

Gregory T. Mayes $189,564 27,676 55,114 37,500

Robert G. Petit $137,475 29,078 50,931 49,986

Sara M. Bonstein $104,109 26,953 34,530 33,333

1) Above figures are as of January 4, 2016. Represents RSU awards & share purchases only. Does not include options and/or warrants.

Anticipated Milestones

Programs Event Timing

Axalimogene

Filolisbac

Finish SPA process & initiate enrollment of randomized Phase 3 monotherapy study in high-risk, locally-

advanced cervical cancer (AIM2CERV)Mid 2016

Complete enrollment of Stage 2 of Phase 2 monotherapy study in metastatic cervical cancer (GOG 0265) Late 2016

Complete enrollment of Phase 1 study in combination with MedImmune’s durvalumab for the treatment of

HPV-associated head and neck cancer and metastatic cervical cancer1H 2016

Commence and complete enrollment of Phase 2 study in combination with MedImmune’s durvalumab 2H 2016

Commence enrollment for Phase 2 study in HPV positive, non-squamous, non-small cell lung cancer

following first-line induction chemotherapy1H 2016

Complete enrollment of high dose expansion cohort in Phase 2 study in recurrent cervical cancer 1H 2016

Initiate Phase 2 study in metastatic anal cancer (FAWCETT) 1H 2016

Present data from Phase 1/2 window of opportunity study in HPV positive head and neck cancer 1H 2016

ADXS-HER2Complete enrollment and establish safe dosing level in preparation for expansion in Phase 1b monotherapy

study in solid tumors expressing HER21H 2016

ADXS-PSAComplete enrollment of Part A Phase 1/2 combination study with KEYTRUDA® in prostate cancer 1H 2016

Commence and complete enrollment of Part B Phase 1/2 combination arm with KEYTRUDA® 2H 2016

ADXS-NEOProgress toward filing an IND; conduct preclinical studies in collaboration with academic institutions,

including Memorial Sloan Kettering Cancer Center (MINE™)2016

ADXS-TNBC Finalize preclinical work for multiple-antigen construct with goal of filing an IND in 2016 2016

30

305 College Road East

Princeton, NJ

www.advaxis.com

[email protected]

Our Lm Technology™ utilizes the

efficiency of the entire immune system

by teaching it to recognize the tumor as

a threat, and by weakening the tumor’s

defenses. Once educated by Lm

Technology™, the immune system—

specifically, its killer T cells—are

enabled to do their job and work to

destroy the cancer.

Documents

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