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Immutep TACTI-002 Clinical Results & Update Global Webcast Slides

Immutep will present these slides as part of its global webcast, as follows:

Date & Time: Wednesday, February 26, 2020, 8:00 am Australian Eastern Daylight Time / Tuesday, February 25, 2020, 4:00 pm US Eastern Standard Time

Register: Interested parties can join the webcast by registering via FNN.

A replay of the webcast will also be available at www.immutep.com from the day after the event.

(ASX: IMM, NASDAQ: IMMP)

Notice: Forward Looking Statements

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The purpose of the presentation is to provide an update of the business of Immutep Limited ACN 009 237 889 (ASX:IMM; NASDAQ:IMMP). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Accordingly, these slides and the information they contain should be read in conjunction with past and future announcements made by Immutep and should not be relied upon as an independent source of information. Please refer to the Company's website and/or the Company’s filings to the ASX and SEC for further information.

The views expressed in this presentation contain information derived from publicly available sources that have not been independently verified. No representation or warranty is made as to the accuracy, completeness or reliability of the information. Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside Immutep’s control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this presentation include known and unknown risks. Because actual results could differ materially to assumptions made and Immutep’s current intentions, plans, expectations and beliefs about the future, you are urged to view all forward looking statements contained in this presentation with caution.

Additionally, the INSIGHT investigator sponsored clinical trial described in this presentation is controlled by the lead investigator and therefore Immutep has no control over this clinical trial. This presentation should not be relied on as a recommendation or forecast by Immutep. Nothing in this presentation should be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.

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Eftilagimod Alpha (efti or IMP321)

Targeting LAG-3 / MHC II may lead to multiple therapeutics in numerous indications

IMMUNOSTIMULATION

IMMUNOSUPPRESSION

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APC Efti
Activator
Agonistic IMP761
mAb
APC
LAG-3
Depleting
mAb
MHCII GSK’781 T Cell
Antagonistic Partnered with
mAb
LAG525
Partnered with LAG-3
T Cell
Rheumatoid IBD Multiple
Arthritis Sclerosis
Immuno-oncology Viral Infections
Combination Therapies
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Immutep Controlled Immunotherapy Pipeline (Oncology)*

Notes

(1) In combination with KEYTRUDA® (pembrolizumab) in non-small cell lung carcinoma (“NSCLC”) or head and neck carcinoma (“HNSCC”) (2) INSIGHT Investigator Initiated Trial (“IIT”) is controlled by lead investigator and therefore Immutep has no control over this clinical trial

(3) In combination with BAVENCIO® (avelumab) (4) Late stage refers to Phase IIb clinical trials or more clinically advanced clinical trials

• Information in pipeline chart current as at 25 February 2020

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Efti: an innovative LAG-3 I-O product candidate

• Efti is a soluble LAG-3 protein targeting a subset of MHC class II on APC

• Potentially synergistic with other therapeutic agents, e.g. I-O agents or chemotherapies

“PUSHING THE ACCELERATOR ON IMMUNE RESPONSES”

“RELEASING THE BRAKE ON THE T CELL”

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Efti is an MHC II agonist: APC activator

• boost and sustain the CD8[+] T cell responses

• activate multiple immune cell subsets

LAG-3 antagonist , or blocking, antibodies: Immune checkpoint inhibitor

• increase cytotoxicity of the pre-existing CD8 T cell response

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Efti: a pipeline in a product

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Trafficking of T cells to
Efti has disruptive potential for oncology. tumors (CTLs)
Priming and activation 4
✓ First-in-Class MHCII agonist (APCs & T cells)
✓ good safety profile Efti (APC activator) 3
✓ unique protective IP positioning (unlike Infiltration of T cells
5 into tumors
ICI mAbs) (CTLs, endothelial cells)
✓ encouraging efficacy data
Cancer antigen
✓ low cost of goods presentation
(dentritic cells/APCs)
✓
potential for use in various Efti (APC activator) 2 6
Recognition of cancer
combination settings –> cells by T cells
(CTLs, cancer cells)
efti is a “pipeline in a product”
Chemotherapy 1 7 PD-1/PD-L1
Release of cancer Killing of cancer
cell antigens cells (Immune and
(cancer cell death) cancer cells)
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AIPAC update

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Efti: Clinical Development AIPAC (Phase IIb)

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AIPAC: Active Immunotherapy PAClitaxel in HER2[-] / HR[+] metastatic breast cancer (MBC)

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Arm 1 , 113 patients :
Phase IIb,
Patients with paclitaxel + efti Primary: PFS
multinational,
HR+/HER2- Secondary: OS, safety,
randomized,
MBC Arm 2 , 113 patients : ORR, QoL
double-blind
paclitaxel + placebo
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Primary endpoint will include:

• median PFS including confidence intervals, and

• Hazard Ratio: relative risk of progression compared to placebo; e.g. HR = 0.75 → risk of progression in a group is 25% lower compared to the other group

Status Report

• ✓ Fully recruited in 7 EU countries (227 pts)

• PFS & ORR data expected by end of March 2020

Key features:

1. double blinded potentially pivotal trial in MBC patients → conditional marketing authorization in the EU depending on data

2. broader perspective: validation of Antigen Presenting Cell activators → a new class of active I-O products after the Immune Checkpoint Inhibitors

Notes:

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ORR – overall response rate, DCR – disease control rate, PFS – progression free survival, OS – overall survival, QoL – Quality of life

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Efti positioning in HR[+] /HER2[-] MBC

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Epidemiology:

• 812,500 HR[+] / HER2[-] diagnoses per annum worldwide[(1)]

• approximately 250,000 develop metastatic disease and are eligible to receive chemotherapy

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Diagnosis of
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Diagnosis of Start of chemotherapy
metastatic disease
Endocrine therapy Endocrine therapy ~40% Weekly paclitaxel
Chemo 2 Chemo 3
+/- CD4/6 inhibitors +/- CD4/6 inhibitors SOC in the EU
~45%
~15%
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Current Status:

Typical Patient Population in MBC:

• despite all changes for early treatment lines → no improvement for patients receiving first-line chemotherapy

• number of pre-treatments have increased over recent years → patients receive chemo at a later stage → shortened expected benefit

• taxane monotherapy widely used in first line chemotherapy setting

• no active IO approved / or in late stage trials

• expected that most patients starting with chemotherapy have: • visceral disease

• usually 1 or 2 previous anti-cancer therapies

Efti will be a differentiator for chemotherapies → combination will likely be used more than single-agent paclitaxel right now

Notes (1) Source: GlobalData 2019

MBC – metastatic breast cancer BC – breast Cancer

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Recent MBC approvals and late stage approaches: Selected PFS results and Hazard Ratios

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Notes

(1) Source: FDA and EMA, published data

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Combining efti and anti-PD-1:

TACTI-002

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Rationale for combining efti with PD-1 antagonists

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Efti increases monocyte number in cancer patients

Melanoma

N=51

Source: Krieg et al., Nat. Med. 24, 2018.

• → baseline innate immunity status seems to be important for the response (OS) to pembrolizumab

• → data suggests that low monocyte numbers at baseline are associated with poor efficacy of anti-PD-1 therapy in melanoma patients

• → data shows that the APC activator, efti, boosts innate immunity

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Efti: Clinical Development TACTI-002 (Phase II)

Trial Design + Introduction

• → Phase II, multi-national, open label, Simon`s 2 stage design; PD L1 all comer

• → In collaboration with Merck Sharp & Dohme (MSD)

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  - Eligiblity Part A:

  - 1[st] line met. NSCLC

• Available tumor tissue

• ECOG 0-1

• Adequate organ functions

• PD-L1 all

comer

Part B:

• 2[nd] line met. NSCLC,

• refractory for PD1/PD-L1

30 mg efti SC + 200 mg pembrolizumab IV Up to 12 months then pembrolizumab alone for another 12 months

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Primary endpoint: iORR
(iRECIST)
Secondary endpoints: PFS,
OS, PK, biomarker, PD, safety
and tolerability
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Part C:

• 2[nd] line met. HNSCC

after platinum

Notes:

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NSCLC – non-small-cell lung cancer, HNSCC – head and neck squamous cell cancer, ORR – overall response rate, PFS – progression free survival, OS – overall survival, PK –pharmacokinetics, PD-X – any PD-1 or PD-L1 treatment *as of Feb 20th 2020

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Efti: Clinical Development TACTI-002 - Safety

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TACTI-002: Preliminary results – Safety, all parts

Summary

• In total 48 pts were enrolled between Mar 2019 and Jan 2020[(1)] . Pts received median 7 (range 1-20) IMP321 injections and median of 5 (range 1-16) pembrolizumab (Keytruda[] ) infusions.

• No grade 4 or 5 for the TEAEs described above

• Injection site reactions (n=18 events in 10 subjects, all grade 1) were reported for efti

TEAEs* occured in > 10% of pts (N=48 in total)

Efti has a favorable safety profile in combination with pembrolizumab - no new safety signals observed

• 2 fatal TEAE* (hemoptysis; respiratory failure) unrelated to therapy

• 2 TEAEs leading to permanent discontinuation:

• Hepatitis grade 4 – both study drugs discontinued

• Diarrhoea grade 3 – pembro discontinued

*Treatment Emergent Adverse Event

Notes:

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(1) Preliminary data, cut-off 31-Jan 2020

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Efti: Clinical Development TACTI-002 - 1[st] line NSCLC (Part A)

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TACTI-002: Preliminary[1] results 1[st] line NSCLC – part A, stage 1

→ PD-L1 distribution as expected → PD-L1 all comer trial → Patients are typical NSCLC 1[st] line pts

Notes:

(1) Preliminary data, cut-off January 31 2020 (2) % in reference to evaluable samples; 4 specimens not evaluable by central lab using standard IHC kit (3) Garon et al N Engl J Med 2015;372:2018-28

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Efti: Clinical Development TACTI-002 - 1[st] line NSCLC (Part A, Stage 1) - Results[1]

Responses and Waterfall plot

• → 47.1% iORR acc. to iRECIST in this PD L1 all comer trial

• → Responses in all PD-L1 subgroups

• Responses in all PD-L1 subgroups

• 6/8 iPR confirmed already → 7/8 pts with iPR still under therapy (none discontinued due to PD)

• 12/17 (71%) patients with target lesion decrease

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Part A - 1st line NSCLC
100 Best response:
iPD
75
iSD
iPR
50
25
0
-25
-50
-75 n = 17
cut-off 31-Jan 2020
-100
best % change from baseline
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Notes:

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(1) Preliminary data, cut-off 31-Jan 2020

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Efti: Clinical Development TACTI-002 - 1[st] line NSCLC (Part A, Stage 1) - Results[1]

Spiderplot

→ At data cut-off 10 pts (59%) still under treatment at 7+ months → median PFS not yet reached

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100100 Part A - 1st line NSCLCPart A - 1st line NSCLC PD-L1
Best response:< 1 %
8080
iPD
1-49 %
6060
iSD
>=50%
4040
iPR
N E
202 0
0 0
-20-20
-40-40
-60-60 n =17n =17
-80-80
cut-off 31-Jan 2020 cut-off 31-Jan 2020
-100-100
0 0 8 8 1616 2424 3232 4040 4848
% change compared to start of therapy % change compared to start of therapy
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Main reason for discontinuation

• Progressive disease (n=4)

• Clinical deterioration (n=1)

• Adverse events (n=2):

• G4 hepatitis (treatment related)

• G5 hemoptysis (disease related)

weeksweeks

Patients continuing treatment

Notes:

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(1) Preliminary data, cut-off 31 Jan 2020

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Efti: Clinical Development TACTI-002 - 2[nd] line HNSCC (Part C, Stage 1) - Results[1]

Responses and Waterfall plot

• → Initial iORR of 33.3% in this PD-L1 all comer HNSCC 2[nd] line patient

• Median Age of 66, mostly male (94%)

• ECOG 1 in 47%

• Different subtypes

• • dropped out prior to first restaging

• ** - not yet staged (on therapy < 9 weeks)

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Part C - 2nd line HNSCC
100 Best response:
iPD
75
iSD
50 iPR
25
0
-25
-50
-75 n = 13
cut-off 31-Jan 2020
-100
best % change from baseline
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• LPI - Dec 2019 → 3 pts with outstanding imaging

• 7 pts (39%) had a decrease in target lesions

• All pts with iSD or iPR are still under treatment (median 6.4 months)

Note:

(1) Preliminary data, cut-off 31 Jan 2020

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Comparables and Outlook

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Efti: Clinical Development TACTI-002 (Phase II)

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TACTI-002: Trial design/status details

Notes:

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(1) Preliminary data, cut-off October 2019

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Efti: a pipeline in a product

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Efti is the ideal candidate to combine with
✓ chemo and ✓ PD-1/PD-L1 antagonists
Chemotherapy Eftilagimod PD-1 / PD-L1
Alpha
Pembrolizumab
Taxanes
Nivolumab
Huge
Potential
Other Chemo
Avelumab
…
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TACTI-002 NSCLC (1st line) & HNSCC (2nd line) results are very encouraging and - if further confirmed - support further clinical development.

If AIPAC is positive: validation of Antigen Presenting Cell (APC) activators and birth of a new class of active I-O products after the Immune Checkpoint Inhibitors!

Metastatic breast cancer would be the first entry point of possibly many other indications and combinations to come.

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Thank you!