Life-saving immunomodulating cell therapies

November 2019

FORWARD-LOOKING STATEMENTS

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These slides and the accompanying oral presentation contain forward-looking statements and information. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may”, “might”, “will”, “should”, “could”, “expect”, “plan”, “anticipate”, “believe”, “estimate”, “project”, “intend”, “future”, “potential” or “continue”, and other similar expressions are intended to identify forward looking statements. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for ourproduct candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results todiffer materially from those that we expected. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. This presentation is not, and nothing in it should be construed as, an offer, invitation or recommendation in respect of our securities, or an offer, invitation or recommendation to sell, or a solicitation of an offer to buy, any of our securities in any jurisdiction. Neither this presentation nor anything in it shall form the basis of any contract or commitment. This presentation is not intended to be relied upon as advice to investors or potential investors and does not take into account the investment objectives, financial situation or needs of any investor.

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We develop intelligent immunomodulating cell therapies to rebalance life-threatening hyperimmune responses,

in indications previously considered untreatable.

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Enlivex, Executive Summary

Paradigm shifting

immunotherapy

Multi-billion dollar

underserved markets

Advanced

clinical-stage pipeline

Short regulatory

approval pathwayCash balanceStrong leadership

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For complex, life-threatening

indications without therapies

Bone-Marrow Transplantations

Sepsis | Solid Tumors

with promising Phase IIa results,

initiating Phase II/III studies

Specialized

life-threatening regulation in

Europe potentially enabling post-

Phase II/III marketing approval;

FDA & EU orphan designations

$35 Million invested; Cash

balance supporting

multiple clinical milestone

within 12-18 months

Previously founded and

managed PROLOR Biotech, a

$560M exit event; Signed

partnership with Pfizer, $295

Million down payment

Ticker: ENLV

Fundamentals

$10.1MM shares outstanding

Market cap: ~$75MM

Stock price: ~$7.5

Immune System Fundamentals

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And release signals to recruit special forcesMacrophage & dendritic cells activated

Macrophages & dendritic cells

“eat” the dying cells

The more dying cells they “eat”,

the less alert signals they release

Immune system triggered

Immune system

relaxed

Immune system

relaxing

Alert & relax signalingthe role of macrophages and dendritic cells

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A normal immune response

7

Bacterial or viral

invasionIntrusion is detected Immune system triggered

Kill infected cells

Bacteria infects cells

Special forces arriveDying cells are cleared

from the body

Immune system relaxed

Signals to recruit special

forces are stopped

Signals released to

recruit special forces

Immune system relaxed

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Immune system

out-of-control

Immune-triggered organ failures result in increased morbidity & mortality during sepsis and BMTfailure of macrophages and dendritic cells to relax triggers attacks of immune cells on healthy organs, and may result in organ damage, failure and mortality

Macrophages & dendritic cells release

signals to recruit special forces

They keep on

releasing alert signals

(cytokines)

More special

forces arrive

Start killing

healthy cells and organs

Immune system

triggeredKill infected cellsSpecial forces arrive

Macrophages & dendritic cells

“Eat” the dying cells, but thatis not enough to relax them

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Immune System Fundamentals

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ALLOCETRATM

A challenge to current therapeutic paradigms

Cytokine storms involve:

An acute multifactor problem cannot be overcome with a single drug for a single target…Requires a major shift in therapeutic approach

Dozens of cytokine types Multiple biological processes

Allocetra™

Billions of semi-apoptotic (dying)

ALLOCETRA cells

ready to be infused

Matched or unmatched

(off-the-shelf) donor

blood

Selection of

mononuclear cells ONLY

B cells | T cells | NK cells

Chemically inducing

programmed cell death

of the selected cells

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Rebalancing the immune responses

Cytokine Storm1 Allocetra™ infusion2 Macrophage feeding3 Alert signals decrease4 Normal immune state 5

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Corporate Overview

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Therapeutic product pipeline of live-saving therapies for out-of-control immune indications

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Indication Global Market

Size

Pre Clinical

Phase Ib Phase II/III EU Conditional Marketing Approval

Post EU Marketing US Phase 3

Prevention of post-Bone Marrow Transplantations (BMT)complications

$3B

Adjunctive treatment for prevention of cytokine storms and organ dysfunction in Sepsis

$33B

Treatment of post-BMT complications for steroid refractory patients

$1.3B

Solid tumor “immune checkpoint” microenvironment modulation

$4BSeekingPartner

IIa CompletedII/III Initiation

Q1 2020

Phase II/III InitiationQ1 2020

Phase II InitiationQ2 2021

Phase IbCompleted Recruitmen

t

Preventing & Treating Complications Post Bone-Marrow

Transplantations

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Preventing & treating

complications post bone-marrow transplantations

Bone marrow transplants (BMT) are susceptible to GvHD and other material complications that may lead to non-relapse mortality

Graft-vs-host disease (GvHD), a hyperimmune response,

occurs when the donor T-cells register the host body's

tissues and organs as foreign antigens and initiate an

attack. Other complications such as Hepatic veno-

occlusive disease, Severe endothelial leakage syndrome,

Pneumonitis and Hepato-renal failure are also highly

correlated with cytokine storms (Schots et al Leukemia 2003)

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POST TRANSPLANTATION ALL CAUSE MORTALITY

Complications43%

Primary Cancer

57%

40%

27%

22%

11%

0ther Infection Organ Failure GvHD

Phase IIa clinical data – prevention of complications Preventing GvHD, leading to expedited hospital discharge overall improved outcomes

Hadassah Hospital BMT unit Low Doses of Allocetra, n=7Cohorts 1+2 low doses 35-70mm cells/kg

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High Doses of Allocetra, n=6Cohorts 3+4 high doses 140-210mm cells/kg

50%

43%

0%0%

10%

20%

30%

40%

50%

60%

AC

UTE

GV

HD

GR

AD

E II

-IV

(%

)

0%

GvHD

grade

II-IV

4139

22

0

10

20

30

40

50

60

DAY

S TO

DIS

CH

AR

GE

50%

time to

hospital

discharge28%

16%

0%0%

10%

20%

30%

40%

50%

60%

NO

N R

ELPA

SEM

OR

TALI

TY 2

00 D

AYS

0%

deaths

due to

transplant

complications

TNFR

I Rat

io

IL-6

co

nce

ntr

atio

n (

pg/

ml)

Days

Upper-threshold of

“normal” range

Days

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

5

-2 18 38

TNFRI Ratio in patientswho received HIGH DOSE(210mm cells/kg) ofAllocetra

TNFRI Ratio in patientswho received MEDIUMDOSE (140mm cells/kg) ofAllocetra

TNFRI Ratio in patientswho received LOW DOSE(35mm - 70mm cells/kg)of Allocetra

0

50

100

150

200

250

300

-2 18 38

IL-6 levels in patients who receivedLOW Dose (35mm - 70mmcells/kg) of Allocetra

IL-6 levels in patients who receivedMEDIUM DOSE (140mm cells/kg)of Allocetra

IL-6 levels in patients who receivedHIGH DOSE (210mm cells/kg) ofAllocetra

Cytokine profile post bone-marrow transplantation in 7

patients with ALL, 5 with AML, 1 with CML

UNCONTROLLED

UNCONTROLLED

Phase IIa clinical data - immune activityPreventing uncontrolled signaling levels (cytokine storm)

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Phase II/III endpoints vs Phase IIa data

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Endpoints 30-Day Engraftment6-Months GvHD-Free Survival

(GFS)

Historical averages1 94.4% 30%

Phase IIa(study results2)

100% 100% (n=6)

Phase II/III (required to show statistical significance3)

>=95%

>= 50% (n=54)>= 60% (n=25)>= 70% (n=15)= 100% (n=8)

1 Al-Kadhimi et al., 2014; Gooley et al., 2010, matched related/unrelated donor population; O. Ringden et al. 2013, matched and unmatched donor population

2 Data in matched-related donor population3 Study in matched-unrelated donor population. GFS rates and the number of patients to show statistical significance.

MatchedRelated/Unrelated

Haploidentical

US - -

EU -Zalmoxis(revoked)

Regulatory Approvals

Zalmoxis Reimbursed Pricing

BMT Market

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- $180,000

CompanyRisk Of Cancer

RelapseNon-Relapse

Mortality

Estimated Pricing & TAM

$150,000 x 20,000 Patients PA (global)

=$3.0 Billion TAM

!

!

!

!

! !

!

Phase II/III: prevention of post BMT complications

Addressable global market $3 Billion

Type Open-label, compared to historical controls

Patients 40-60 (Phase II/III, EU Submission)

Duration 1 year / patient

Recruitment 18 months

End-points2 endpoints: (i) 30-day engraftment; (ii) 6-Months GFS (GvHD Free Survival)

Secondary Duration of hospitalization, various others

Study initiation Q1/2020

Prevention of BMT complications Phase II/III Planning

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AllocetraTM

Adjunctive therapy for the Prevention of multiple organ failure & mortality in Sepsis

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AllocetraTM

Adjunctive therapy for the prevention of sepsis-related cytokine storms & organ dysfunction

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50%50% Organ Damage

Mortality

Severe25%

Mild orModerate

75%

OUTCOME

SEPSIS CATEGORIES

Sepsis is the 3rd leading cause of death in the U.S.#1 Cardiovascular #2 Cancer

SEPSIS is a body’s overwhelming, life-threatening response to infection, involving hyper activity

of the immune system. It can lead to tissue damage, organ failure, and death.

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Sepsis severity & cytokine storm

Viral/Bacterial Problem Zone

Cytokine Storm Problem Zone

Magnitude

Time

TreatmentAnti-Viral/AntibioticsFluids, Vasopressors

TreatmentUnmet medical needOrgan

Failure Zone

Recovery Zone

Death Zone

Pro-inflammatory cytokines Anti-inflammatory cytokines

The only pharmacologic treatments currently used, without success, for sepsis

are antibiotic agents, fluids, and vasopressors.

an adjunctive therapy for preventing cytokine storms and organ dysfunction in Sepsis, in combination with existing antibiotics agents.

Designed to offer a true paradigm shift in the quest to solve a complex healthcare challenge.

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Allocetra™

1 Ertapenem (an antibiotic drug by Merck) is a highly effective antibiotic agent commonly used for the treatment of severe or high-risk bacterial infections.This drug is usually reserved for known or suspected multidrug-resistant (MDR) bacterial infections. It is standard of care for Sepsis identified from urinary or abdominal infections.

The CLP model is a highly aggressive sepsis model causing widespread infection that results in 90%-100% mortality within 100 hours

Post induction survival, severe sepsis model (pre-clinical)

0

20

40

60

80

100

0 25 50 75 100 125 150 175 200

% S

urv

ival

Hours post CLP (Sepsis Induction)

CLP (cecum ligation and puncture) only

CLP + Ertapenem + vehicle

CLP + Ertapenem + Allocetra-OTS

n= 16

n= 20 p< 0.001

n= 15

Survival rate 10X higherthan antibiotics alone

60%Survival

6%Survival

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Low clinical score, severe sepsis model (pre-clinical)

0.0

2.0

4.0

6.0

8.0

10.0

12.0

14.0

16.0

18.0

20.0

0 3 23 30 32 48 51 55 73 97 120 126 145 168

Clin

ica

l Sco

re

Hours post CLP

Cecal ligation and puncture (CLP) only

CLP + Ertapenem + Hartmann

CLP + Ertapenem + Allocetra-OTS

High Clinical Score

Means Clinical

Deterioration

Clinical Score Correlates to Survival in CLP-induced Sepsis Models

60%SURVIVAL

6%SURVIVAL

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Immune activity profile, severe sepsis model (pre-clinical)

1,284

20

1,167

366

0

200

400

600

800

1,000

1,200

1,400

1,600

pre-CLP 24h

TNFα

(pg/

ml)

TNFα

5,469

50

4,649

247

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

pre-CLP 24h

IL-6

(p

g/m

l)

IL-6

CLP CLP + Ertapenem CLP + Ertapenem + OTS-ALLOCETRA

5XINCREASE

110XINCREASE 64X

INCREASE

18XINCREASE

ALLOCETRA™ prevents uncontrolled signaling levels (cytokine storm) post sepsis induction, leading to increased survival

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AllocetraTM

Adjunctive therapy for the Prevention of multiple organ failure & mortality in Sepsis

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AllocetraTM

Phase Ib Clinical TrialInterim Results

Severe Sepsis PatientsOff-The-Shelf Universal Product

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Time 0Sepsis diagnosis

Prevention of Sepsis-related Organ DysFunction with Allocetra-OTS (P-SOFA-1) Clinical Trial

Main Inclusion Criterion• Meet Sepsis 3 criteria: the

presence of organ dysfunction as identified by a presence of SOFA score > 2 over baseline

Day 1Allocetra Infusion140mm cells/kg

6 Patients

Cohort 1

Day 1Allocetra Infusion140mm cells/kg

4 Patients

Cohort 2

Day 3Allocetra Infusion140mm cells/kg

+

10 Patients

Total

Primary endpointSafety at 28 days

Open-label, compared to matched historical controls at the same hospital

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High Degree of Matching• Age distribution• Gender matching• SOFA score at admission• Source of Sepsis• Admission years: 2016-2019

Treated

Non-Treated

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50-60 61-70 71-80 81-90

ALL Patients, Age Distribution

Patients Characteristics – Matched Controls, All Cases 2016-2019, Hadassa Hospital, Jerusalem, Israel

0%

10%

20%

30%

40%

50%

60%

1 2 3 4 5 6 7 8 9

Per

cen

t o

f P

atie

nts

SOFA Score At Admission

ALL Patients, SOFA at Admission

0%

20%

40%

60%

80%

100%

Treated (n=6) Matched Controls (n=37)

Pneumonia

MRSA

UTI

All Patients, Source of Sepsis

Comparative Interim Data: SOFA At Admission & Sepsis-Associated Mortality

For The Matched-Controls Group, Mortality Associated Mostly With Low SOFA Scores At Admission

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9%

0%

27%

45%

0%

18%

0% 0% 0%0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

1 2 3 4 5 6 7 8 >=9

Pe

rce

nt

of

Tota

l Mo

rtal

itie

s

SOFA At Admission

All Patient Mortalities Within Matched Controls Group As Function Of SOFA at Admission

Non-Treated Mortality DistributionAcross Initial SOFA

Comparative Interim Data: Recovery From Sepsis

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0%

20%

40%

60%

80%

100%

0 1 2 3 4 5 6 8 10 12 14 21 23 25 27

Days To Sespis Cure

Non-Treated (n=37) Treated (n=6)

ALLOCETRA is highly effective in treatment of Sepsis Swiftly After Admission

All Subjects, % Patients With Complete Organ Failure Recovery By Days From Admission

49%

100%

0%

20%

40%

60%

80%

100%

120%

Non-Treated (n=37) Treated (n=6)

ALL Subjects, % Patients With Complete Organ Failure Recovery During 28 days

Comparative Top-Line Data: Recovery From Sepsis, Mortality, ICU Hospitalization

ALLOCETRA is highly effective in prevention of Sepsis-associated mortality

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After 6 Days, Only 43% Of ALL Matched Controls Released From ICU

Compared With 100% Of Treated

0%

20%

40%

60%

80%

100%

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30

Days In ICU

ALL Patients, % Still In ICU Post Admission

Matched Controls (n=37)

Treated (n=6)

ALLOCETRA is highly effective in expediting recovery

0% No Mortality

29%

23%

0%

5%

10%

15%

20%

25%

30%

35%

Treated (n=6) Non-Treated Literature

ALL Subjects, % Patients Mortality

Comparative Interim Data: Organ Dysfunction & Failure

ALLOCETRA prevents organ dysfunction and failure

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4.50 4.503.97

8.11

0.00

2.00

4.00

6.00

8.00

10.00

12.00

14.00

Avg Baseline SOFA Avg MAX SOFA

ALL Subjects, Avg Baseline SOFA & Maximum SOFA

Treated (n=6)Matched Controls (n=37)

Median values similar to averages:Treated baseline: 4.5 Treated Max: 4.5Non-Treated baseline: 4 Non-Treated Max: 8

0%

78%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

Treated (n=6) Non-Treated (n=37)

ALL Subjects, % Patients With SOFA Increase From Time Of Admission

Comparative Interim Data: Organ Dysfunction & Failure

Prevention of SOFA increase by 4 or more points is critical to prevent mortality

ALLOCETRA prevents SOFA increase by 4 or more points

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57%

0%

10%

20%

30%

40%

50%

60%

Treated (n=6) Non-Treated (n=37)

% of Patients With SOFA Increase >= 4

Treated (n=6) Non-Treated (n=37)

52%

0%

10%

20%

30%

40%

50%

60%

Treated (n=6) Non-Treated (n=37)

% Mortality of Patients With SOFA Increase >= 4

Treated (n=6) Non-Treated (n=37)

0% No Increase

0% No Mortality

Sepsis Phase II/III

Addressable global market $33 Billion market (severe Sepsis only)

Type Controlled, randomized

Patients 60 (40 treated, 20 control)

Duration 28 days / patient

Recruitment 12 Months

End-points Composite organ damage/failure (SOFA) score max vs baseline in 28 days

Secondary Mortality

First patient dosed Q1/2020

Sepsis- Phase II/III clinical plan

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Solid Tumor Treatment

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Solid Tumor Treatment

Solid tumors’ micro-environment modulation

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Enlivex discovered a proprietary

“immune checkpoint” pathway

for solid tumors, which is

activated by the engulfment of

Allocetra™ by tumor-associated

macrophages, rendering the solid

tumor microenvironment

“tumor negative”

TUMOR

80% 20%

BLOOD CANCERS SOLID CANCERS

OVERALL RESPONSE TO THERAPY

SCID-Bg mice were injected intra-peritoneally with human HeLa-CD19-luciferase cells, followed by CD19-CAR T cells, with or without apoptotic cells (Allocetra-OTS), or opsonized apoptotic cells (D89E_Allocetra-OTS).

Opsonized apoptotic cells are NOT engulfed by resident macrophages, while Allocetra-OTS is engulfed by resident macrophages surrounding the tumor

0

10

20

30

40

50

60

70

80

90

100

110

0 20 40 60 80 100 120 140 160

% S

urv

ival

Days To Mortality

HeLaCD19

HeLa-CD19 + CAR-T

HeLa-CD19 + CAR-T + Allocetra-OTS

HeLa-CD19 + CAR-T + D89E_Allocetra-OTS

Substantial increase in complete remission & survival, solid tumor model (pre-clinical)

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ALLOCETRA™ has received FDA & EU orphan drug designations for GVHD

USA conditional approval (RMAT)

Phase II

Open-label

Single arm

Small # of patients

Initiate post-marketing phase III

Initiate USA sales

Accelerated regulatory pathways for life-saving, unmet medical need indications

EU conditional approval

Phase II

Open-label

Single arm

Small # of patients

Initiate post-marketing phase III

Initiate EU sales

Q1/19 Q2/19 Q3/19 Q4/19 Q1/20 Q2/20 Q3/20 Q4/20 Q1/21 Q2/21 Q3/21 Q4/21 Q1/22 Q2/22 Q3/22 Q4/22

Phase Ibstudy initiation (ISR)

Phase II/III initiation

Phase II/III full data

EU conditional marketing application filed

Phase II/III study initiation (EU/ISR)

EU conditional marketing application granted

Full 6-months GCFS efficacy data

Full 12-months mortality data

Prevention of GvHD & Transplant Complications

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Clinical milestones planned timeline

Prevention of organ failure & mortality in Sepsis

Phase II interim30 patients clinical data

10 Sepsis patients clinical data

# Patients:patients’ interim clinical data30-Day engraftment & 6M GFS endpoints

173 4030

Full 30-day engraftment efficacy endpoint data

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Thank You

www.enlivex.com

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