Life-saving immunomodulating cell therapiesJune 2019

Shmulik Hess, PhD CEO

NASDAQ: ENLV

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.

Enlivex, Executive Summary

Paradigm shifting immunotherapy

Multi-billion dollarunderserved markets

Advanced clinical-stage pipeline

Short regulatory approval pathway Cash 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

Specializedlife-threatening regulation in

Europe potentially enabling post-Phase II marketing approval;

FDA & EU orphan designations

$35 Million invested; Cash balance supporting

multiple clinical milestone within 12-24 months

Previously founded and managed PROLOR Biotech,

sold For $560M; Signed partnership with Pfizer, $295

Million down payment

Ticker: ENLV

Fundamentals

10.1 MM shares outstandingMarket cap: ~$120MM

Stock price: ~$12

A normal immune response

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Bacterial or viralinvasion Intrusion 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

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 systemrelaxed

Immune systemrelaxing

Alert & relax signalingthe role of macrophages and dendritic cells

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Immune systemout-of-control

Cytokine stormstrigger 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 onreleasing alert signals

(cytokines)

More special forces arrive

Start killing healthy cells and organs

Immune systemtriggered Kill infected cellsSpecial forces arrive

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

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Allocetra™

Billions of semi-apoptotic(dying) ALLOCETRA cells

ready to be infused

Matched or unmatched (off-the-shelf) donor

blood

Selection ofmononuclear cells ONLYB cells | T cells | NK cells

Chemically inducing programmed cell death

of the selected cells

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Rebalancing immune responses

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

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This results in lower expression of cytokines, rebalancing the system to its normal immune stateWhile digesting the dying cells, macrophages and dendritic cells undergo a process of toleration,become less aggressive, and release fewer alert signals

Macrophages and dendritic cells, who, among other things, have the primary biological roleto clear apoptotic cells from the body, feed on the infused cells

Allocetra™, comprised of billions of densely concentrated early-apoptotic (dying) cells,is infused into the patient’s blood stream

A systemic inflammatory response in which cytokine release spirals out of control,triggering severe immune attacks on multiple healthy organs

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 therapy for resolving cytokine storms in Sepsis $33B

Treatment of post-BMT complications for steroid refractory patients

$1.3B

Solid tumor “immune checkpoint” microenvironment modulating $4B Seeking

Partner

IIa CompletedII/III Initiation

Q1 2020

Phase II InitiationQ4 2019

Phase II InitiationQ3 2020

Phase IbOngoing

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

Graft-vs-host disease (GvHD), a hyperimmune response,occurs when the donor T-cells register the host body'stissues and organs as foreign antigens and initiate anattack. Other complications such as Hepatic veno-occlusive disease, Severe endothelial leakage syndrome,Pneumonitis and Hepato-renal failure are also highlycorrelated with cytokine storms (Schots et al Leukemia 2003)

60% 40%

Grade II 25% MortalityGrade III-IV 80% Mortality

60%40%

ResponsiveNon-Responsive 90% Mortality

GvHD50%

GvHD-Free50%

POST TRANSPLANTATION GVHD PREVALENCE

GVHD SEVERITY RESPONSE TO STEROIDS

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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%

1&0%

10%

20%

30%

40%

50%

60%

ACU

TE G

VHD

GRAD

E II-

IV (%

)

0%GvHD

grade

II-IV

4139

22

0

10

20

30

40

50

60

DAYS

TO

DIS

CHAR

GE

50%time to

hospital

discharge28%

16%

0%0%

10%

20%

30%

40%

50%

60%

NO

N R

ELPA

SEM

ORT

ALIT

Y 20

0 DA

YS

0% deaths

due to

transplant

complications

TNFR

I Rat

io

IL-6

con

cent

ratio

n (p

g/m

l)

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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MatchedRelated/Unrelated

Haploidentical

US - -

EU - Zalmoxis

Regulatory Approvals

Zalmoxis Pricing

BMT Market | Adjunctive

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- $180,000

Company Risk Of Cancer Relapse

Non-Relapse Mortality

Estimated Pricing & TAM

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

$3.0 Billion TAM

!

!

!

!

! !

!

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

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

urvi

val

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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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

2470

1,000

2,000

3,000

4,000

5,000

6,000

7,000

pre-CLP 24h

IL-6

(pg/

ml)

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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RegulatoryApprovals

Number of Annual Patients

US - 1.7M

EU - 1.0M

S i g n i f i c a n t d e m a n d , n o a p p r o v e d d r u g

Severe sepsis segmentation & market size ($US)

Sepsis Market

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Company Addressable issue

Mechanism of action

Suitability across Sepsis

causes

Prevent Vascular Leakage

Increase Arterial Pressure

Severe Pneumonia

Immunemodulator

ALL Overall Immune Relaxation

$21.25B

$12.50B US

EU

* SOURCE: US Centers for Disease Control and Prevention (CDC) 2018

Estimated Pricing & TAM

$50,000 x 675,000 Patients PA (global)=

$33 Billion TAM

!

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™

TUMOR

80% 20%BLOOD CANCERS SOLID CANCERS

OVERALL RESPONSE TO CAR-T

Substantial increase in survival & remission (pre-clinical)

0

10

20

30

40

50

60

70

80

90

100

0 20 40 60 80 100 120 140 160

% S

urvi

val

Days

HeLa-CD-19 HeLa-CD19 + Mock-T HeLa-CD19 + CAR-T HeLa-CD19 + CAR-T + OTS-ALC-4K

n=40(p<0.001)

CAR-T Alone

CAR-T + ALLOCETRATM

Complete Remission 0% 20%SurvivalDuration +83% +233%

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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 (PRIME)

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 initiation

Phase II full data

EU conditional marketing application filed

Phase II study initiation (EU/ISR)

Phase II/III study initiation (EU/ISR)

Interim 28 days data

EU conditional marketing application granted

Full data

Full 6-months GCFS efficacy data

Full 12-months mortality data

EU conditional marketing application filed

US Phase III initiationInterim data

Full data

Prevention of GvHD & Transplant Complications

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Clinical milestones planned timeline

Prevention of cytokine storms in Sepsis

GvHD Treatmentof steroid refractory

Phase II interim20 patients clinical data

10 Sepsis patients clinical data

# Patients:patients’ interim clinical data30-Day CRS & 6M GCFS endpoints

173 4030

Full 30-day CRSefficacy endpoint data

Cell-therapy breakthroughs are disruptive in nature

Players

Hard to treat Recurring blood cancers Recurring blood cancers• Sepsis• Post BMT complications• Steroid Refectory GvHD

History of failure ✓✓✓>90% mortality

✓✓✓>90% mortality

✓✓✓>50% mortality (Sepsis)>50% mortality (BMT)>90% mortality (SR GvHD)

Breakthrough innovationNew immuno-therapy

mechanism of action viamodified T-cells

New immuno-therapy mechanism of action via

modified T-cells

New immuno-therapy mechanism of action viadying T, B and NK cells

Exit $12 Billion $9 Billion TBD

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Thank You

www.enlivex.com

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