IMMUTEP LIMITED — Investor Presentation 2021

Sep 26, 2021

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The global leader in developing LAG-3 therapeutics Corporate Presentation September 2021

(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.

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.

This presentation was authorised for release by the CEO, Marc Voigt.

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Overview

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Immutep

is an innovative biotechnology company developing novel immunotherapies for cancer and autoimmune disease

Globally active

Leadership position in LAG-3

with 4 product candidates in immuno-oncology and autoimmune disease

Clinical Potential

Immutep’s product candidates have demonstrated clinical potential in a range of indications with high unmet need

Collaborating with industry leaders

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LAG-3 Pioneer

French immunologist

Prof. Frédéric Triebel, Immutep CMO & CSO

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LAG-3 Overview - The most promising immune checkpoint -

Agonist	Agonist	Agonist	Agonist	Agonist	Agonist	Agonist	Agonist	Agonist
	Company	Program	Preclinical	Phase I	Phase II	Phase III	Total Trials	Patients
		Eftilagimod Alpha(5)		10	4		14	967
	BMS	Relatlimab		7	32	2	41	9,706
		Ieramilimab		1	4	~~PDUFA i~~	5	960
Antagonist Agonist Depleting AB Autoimmune Oncology
	Merck & Co. Inc.	Favezelimab		1	5	~~meetng~~ March 19, 2022	6	1066
	Macrogenics	Tebotelimab		3	3		6	1422
	H-L Roche	RO7247669		1	2		3	538
	B.I.	BI754111		4	1		5	649
	Regeneron(1)	Fianlimab		1	1		2	836
	Tesaro(3)	TSR-033		1	1		2	139
	Incyte	INCAGN02385		1	1		2	74
	Symphogen(2)	SYM022		3			3	169
	F-star	FS-118		2			2	102
	Innovent	IBI110		1			1	268
	Xencor	XmAb-22841		1			1	242
		IMP761					--	--
	(4)	GSK2831781 (IMP731)		2	1		3	207

5

Sources: GlobalData, Company websites, clinicaltrials.gov, and sec.gov, as of September 2021. The green bars above represent programs conducted by Immutep &/or its partners. Total trials includes all active, completed &/or inactive trials. Patient totals are based on estimated total enrolled &/or to be enrolled. Not a complete list of currently existing LAG-3 products.

• 1) As of January 7, 2019 Regeneron is in full control of program and continuing development (https://www.sec.gov/Archives/edgar/data/872589/000110465919000977/a19-1325_18k.htm)

• 4) Includes two completed Phase I studies and one discontinued Phase 2 study

• 5) Including IITs, two planned trials (MBC trial by EOC and HNSCC trial) and the EAT COVID trial

• 2) On 3 Apr. 2020 Les Laboratoires Servier acquired Symphogen

• 6) RELATIVITY-047 (https://investors.bms.com/iframes/press-releases/press-release-details/2021/Bristol-Myers-Squibb-Announces-RELATIVITY047-a-Trial-Evaluating-Anti-LAG-3-Antibody-Relatlimab-and-Opdivo-nivolumab-in-Patients-with-Previously-Untreated-Metastatic-or-UnresectableMelanoma-Meets-Primary-Endpoint-of-Progression-Free-Survival/default.aspx)

• 3) Tesaro was acquired by and is now part of GSK (www.gsk.com/en-gb/media/press-releases/gsk-completes-acquisition-oftesaro-an-oncology-focused-biopharmaceutical-company/ )

MHC II / LAG-3 Interaction is Clinically Validated as a Therapeutic Target

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LAG-3, an immune checkpoint, is widely expressed on tumor infiltrating lymphocytes (TILs) and cytotoxic T cells, and interacts with MHC class II molecules on antigen presenting cells (APCs)

→ Prime target for immune therapy

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LAG-3 / MHC Class II Interaction
T Cell
APC
LAG-3
MHCII
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Positive regulation of antigen presenting cells ( APCs ) via MHC II transferred activating signals → increase in antigen presentation to cytotoxic CD8[+ ] T cells

Negative regulation of LAG-3[+] T Cells

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• Relatlimab + 15 more products in clinical development

• Clinical validation at ASCO/ESMO 2021 (RELATIVITY-047 - relatlimab + nivolumab in melanoma)

• PDUFA target action date is March 19, 2021*

MHC II (APC) / LAG-3 (T cell) interaction is important for tumor immunology

• This APC / T cell interaction is now a validated target since ASCO 2021 → 3[rd] validated checkpoint in immunooncology

*The PDUFA date refers to the date the Food and Drug Administration (FDA) are expected to deliver their decision whether or not a approve a companies New Drug Application (NDA) or Biologics License Application (BLA).

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Targeting LAG-3 / MHC II:

Immutep has multiple therapeutics in numerous diseases

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IMMUNOSTIMULATION IMMUNOSUPPRESSION
Efti IMP761
APC Agonistic
activator mAb
APC Partnered with
LAG-3
MHC II
GSK’781
Partnered with Depleting
mAb T Cell
LAG525
Antagonistic
LAG-3
mAb
L AG-3
T Cell
RELEVANT Immuno-oncology Viral RELEVANT Rheumatoid IBD Multiple
DISEASES Combination Infections DISEASES Arthritis Sclerosis
Therapies
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• ✓ Immutep is the only company with four LAG-3 related compounds, each with a different mechanism of action for treatment of numerous diseases

• ✓ Two major partnerships with pharma and two products under own development

Notes:

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• APC: antigen presenting cell

Immutep’s LAG-3 Trial Pipeline*

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Oncology Autoimm. Inf. Dis.	Program	Preclinical	Phase I	Phase II	Late Stage(5)	Commercial Rights	Market Size(6)
	Eftilagimod Alpha (efti or IMP321) APC activating soluble LAG-3 protein	Metastatic Breast Cancer (C AIPAC	hemo – IO)			Global Rights	US$29.9 billion
		Head and Neck Squamous TACTI-003	Cell Carcinoma (IO – IO)(1b)				US$1.9 billion
		Head and Neck Squamous TACTI-002	Cell Carcinoma (IO – IO)(1)
		Non-Small-Cell Lung Carci TACTI-002	noma (IO – IO)(1)				US$22.6 billion
		Solid Tumors (IO – IO)(2), (3 INSIGHT-004	a)
		Solid Tumors (IO – IO)(2), (3 INSIGHT-005	b)		§
		Solid Tumors (IO – IO – ch INSIGHT-003	emo)(2)
		Solid Tumors (Cancer Vacc YNP01 / YCP02 / CRESCE	ine)(4a) NT 1
		Metastatic Breast Cancer (C	hemo – IO)(4b)		§	Chinese Rights	US$2.3 billion
	Efti	COVID-19 disease (Monoth EAT-COVID	erapy)(7)		~~§~~	Global Rights(8)
	IMP761 (Agonist AB)				~~§~~	Global Rights	US$149.4 billion (2025)
Notes
*

• Information in pipeline chart current as at September 2021

• (1) In combination with KEYTRUDA® (pembrolizumab) (1b) Planned new trial for 1[st] line HNSCC patients

Late stage refers to Phase IIb clinical trials or more clinically advanced clinical trials GlobalData Market Size forecast for US, JP, EU5, Urban China and Australia; KBV Research: https://www.kbvresearch.com/autoimmune-disease-therapeutics-market/)

• (5)

• (2) INSIGHT Investigator Initiated Trial (“IIT”) is controlled by lead investigator and therefore Immutep has no control over this clinical trial

(6)

• (3) a) In combination with BAVENCIO® (avelumab); b) in combination with Bintrafusp alfa

(7) IIT conducted by University Hospital Pilsen. Immutep has no control over this trial. Ex China

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Immutep Out-Licensed Immunotherapy Pipeline*

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Commercial
Program Preclinical Phase I Phase II Late Stage [(1)] Updates
Rights/Partners
Solid Tumors + Blood Cancer (IO-IO Combo)
Triple Negative Breast Cancer (Chemo-IO Combo)
Novartis currently has five
Global Rights clinical trials ongoing for
LAG525
Melanoma (IO-IO-Small Molecule Combo) LAG525 in multiple cancer
(Antagonist AB)
§ indications for approx. 1,000
patients [(4)]
Solid Tumors (IO-IO Combo)
Triple Negative Breast Cancer
(Chemo-IO-Small Molecule Combo)
Ulcerative ColitisUlcerative Colitis [(6)]
Two successful Phase I
Global Rights studies. Phase II clinical
GSK‘781
Healthy Japanese and Caucasian Subjects [(2)]
study in up to 242 ulcerative
(Depleting AB)
§ colitis patients was
discontinued.
Psoriasis [(3)]
Oncology
Autoimmune
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Notes

9 * Information in pipeline chart current as at September 2021 9 (1)

(1) Late stage refers to Phase IIb clinical trials or more clinically advanced clinical trials (2) Reflects completed Phase I study in healthy volunteers

(4)

(5)

https://clinicaltrials.gov/ct2/results?cond=&term=LAG525&cntry=&state=&city=&dist= https://clinicaltrials.gov/ct2/results?cond=&term=GSK2831781&cntry=&state=&city=&dist= and https://www.gsk.com/media/5957/q1-2020-results-slides.pdf Discontinued in Jan 2021

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Eftilagimod Alpha (efti or IMP321)

Efti: an Innovative LAG-3 I-O Product Candidate

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

• Potentially synergistic with other therapeutic agents e.g. immuno-oncology (I-O) agents & 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 (blocking) antibodies: Immune checkpoint inhibitor

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

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Efti: Potential Pipeline in a Product Potential for use in various combination settings

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Unique MHC II agonist

Excellent safety profile

Encouraging efficacy data

Low cost of goods

Unique protective IP positioning (unlike ICI mAbs)

Chemo-IO combo

IO-IO combo

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Efti + anti-PD-1 Combination TACTI-002 Update from ASCO 2021

TACTI-002 (Phase II)

Design & Status

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TACTI-002: Two ACTive Immunotherapeutics in NSCLC and HNSCC

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UNSELECTED FOR PD-L1
PART A:
S
1 [ST] LINE MET. NSCLC
C
R
PART B: COMBINED
E
2 [ND] LINE MET. NSCLC, IMMUNOTHERAPY
E
PEMBROLIZUMAB + EFTI FOR 12
N REFRACTORY TO PD-1/PD-L1 MONTHS + 12 MONTHS
TARGETING THERAPY PEMBROLIZUMAB MONO
I
N
PART C:
G
2 [ND] LINE MET. HNSCC AFTER Recruitment Status Report
PLATINUM THERAPY
✓ Fully approved in all countries
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In collaboration with

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ORR, PFS, OS, PK, biomarker, safety and tolerability

Sites in Europe / US / Australia

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• ✓ Up to 183 patients in three indications

30 mg efti (IMP321) s.c. Treatment 200 mg pembrolizumab (Keytruda[] ) i.v.

• Part A (N=36) completed; extension cohort (N=74 recruiting)

• ✓ Part C (N=39) completed

• ✓ Part B (N=36); completed

Notes:

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

TACTI-002 Results[(1)]

1[st] line NSCLC (Part A)

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• -

• PD-L1 distribution as expected (~70% with < 50% PD-L1 expression) → PD L1 all comer trial

• Patients are typical NSCLC 1[st] line pts

Baseline parameters	N (%)
Age (years), median (range)	68.5 (53-84)
Female Male	11 (30.6) 25 (69.4)
ECOG 0 ECOG 1	15 (41.7) 21 (58.3)
Current / Ex-smokers Non-smokers	34 (94.4) 2 (5.6)
Squamous pathology Non-squamous pathology	15 (41.7) 21 (58.3)
Patients with liver metastasis	14 (38.9)

Best overall response, iRECIST, N = 36	Local Read (investigator) N(%)	Blinded Read (BICR) N(%)
Complete Response	2 (5.6)	2 (5.6)
Partial Response	11 (30.6)	13 (36.1)
Stable Disease	11 (30.6)	10 (27.8)
Progression	8 (22.2)	6 (16.7)
Not Evaluable**	4 (11.1)	5 (13.9)
Disease Control Rate	24 (66.7)	25 (69.4)
Overall Response Rate [95% CI interval]*	13 (36.1) [20.8-53.8]	15 (41.7) [25.5-59.2]
Overall Response Rate – Evaluable pts *[95% CI interval]	13(40.6) [23.7-59.4]	15(48.4) [30.1-60.9]

• - All patients stage 1 and 2 (N=36) with ≥ 1 treatment

• ** - dropped off prior to first staging or were not evaluable post-baseline for any reason

• *** - Evaluable for efficacy meaning ≥ 1 treatment and ≥ 1 post baseline tumor staging

Notes:

(1) Preliminary data, cut-off Apr 16, 2021 15 ECOG… Eastern Cooperative Oncology Group iRECIST… Immune Response Evaluation Criteria In Solid Tumors BICR… Blinded Independent Central Review

TACTI-002 Results[(1)] 1[st] line NSCLC (Part A)

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120 Best response:
iUPD/iCPD 100 Best response:
100
iSD iUPD/iCPD
75
60 iSD
iPR
iPR
40 iCR 50
iCR
20
25
0
0
-20
-25
-40
-60 -50
-80
-75
cut-off 16-Apr 2021; n= 33
-100 N=33; ** LN as target lesion; *** - pt had SD but < 6 wks --> BOR =
NE; NY not yet; NE not evaluable
0 12 24 36 48 60 72 84 96 108 120 -100
PD-L1 TPS
% change compared to baseline
Best % change from baseline

50 % 80 % 50 % 15 % 3 % 15 % 80 % 0 % 50 % 70 % 10 % 10 % 10 % 1 % 100 % 0 % 50 % 75 % 90 % 90 % 75 % 100 % 0 %
25 % 0 % 1 % 2 % 40 % <1 % 0 % <1 % 15 % 35 %

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weeks … patients still under therapy
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Duration of response (DoR)

• 92% responses confirmed

• 58% confirmed responses ongoing with 6+ months

• 42% of confirmed responses progressed after 6.5-13.8 months

• Responses at all PD-L1 levels including 1 Complete Response with TPS of 0%

• At data cut-off, 7 pts still under therapy and 1 patient completed the 2 years of therapy

• Median DoR estimated 13+ months

(1) Preliminary data, cut-off Apr 16, 2021 Graphs represent all patients with at least one post baseline assessment. One patient has no official RECIST assessment as this was done < 6 weeks and this does not qualify according to RECIST. Per local investigator assessment. iRECIST… Immune Response Evaluation Criteria In Solid Tumors

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TACTI-002 Results[(1)]

1[st] line NSCLC (Part A) - Benchmarking

	PD-L1 (TPS)	Pembro alone (NSQ+SQ)**	Pembro + Efti *(NSQ+SQ)
ORR (%)	≥ 50	39.5	53.8*
	≥ 1	27.3	44.0*
	< 50	--	31.6*
PFS (mths)	Overall pop.	--	8.2
	≥ 50	7.1	11.8
DoR (mths)	Overall pop.	20.2	NR (currently 13+)
Toxicity		Well tolerated	No significant add. toxicity

• Pts with PD-L1 results available and ≥ 1 post baseline RECIST assessments (32/36); ** Data for pembro derived from KN042, KN189, KN-407[(2)(3)(4)] ; *** According to investigator read

• Increased ORR & median PFS

• Responses in PD-L1 low expressors

• Comparable safety profile

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ORR

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Data for pembro derived from KN042 and KN001[(2)(5)]

(1) Preliminary data, cut-off 16 Apr 2021 for TACTI-002 (4) (2) KEYNOTE-042: TSK Mok et al, The Lancet 2019, http://dx.doi.org/10.1016/S0140-6736(18)32409-7 (5) (3) KEYNOTE-189: S Gadgeel et al, J Clin Oncol 2020, https://doi.org/10.1200/JCO.19.03136

(4) KEYNOTE-407: L Paz-Ares et al, N Engl J Med 2018;379:2040-51. DOI: 10.1056/NEJMoa1810865 (5) KEYNOTE-001: NB Leighl et al, The Lancet 2019, http://dx.doi.org/10.1016/S2213-2600(18)30500-9

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TACTI-002 Results[(1)]

2[nd] line HNSCC (Part C)

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• 2[nd] line treatment for patients after platinum therapy. PD-L1 all comer population

• Doubling the ORR compared to historical pembro mono results with 13.5% Complete Responses

Baseline parameters (N=39)	N (%)
Age, median (years)	62 (37-84)
Female Male	4 (10.3) 35 (89.7)
ECOG 0 ECOG 1	13 (33.3) 26 (66.7)
Current / Ex-smokers Non-smokers	33 (84.6) 6 (15.4)
Previous chemotherapy	39 (100)
Previous cetuximab	16 (41.0)
Lung lesions Liver lesions	19 (48.7) 6 (17.6)

Primary tumor location (N=39)	N (%)
Oral cavity	12 (30.8)
Oropharynx	14 (35.9)
Hypopharynx	7 (17.9)
Larynx	6 (15.4)

Best overall response*, iRECIST	Investigator assessment N (%)
Complete Response	5 (13.5)
Partial Response	6 (16.2)
Stable Disease	3 (8.1)
Progression	17 (45.9)
Not Evaluable**	6 (16.2)
Disease Control Rate	14 (37.8)
Overall Response Rate [95% CI interval]	11 (29.7) [15.9-47.0]
Overall Response Rate – Evaluable pts *[95% CI interval]	11 (35.5) [19.2-54.6]

• - All patients (N=37) with ≥ 1 treatment and no death due to COVID-19 prior to first post-baseline staging ** - dropped off prior to first staging or were not evaluable post-baseline for any reason

• *** - evaluable patients (N=31): ≥ 1 treatment and ≥ 1 post baseline tumor staging

All four pathologies enrolled

Note:

(1) Preliminary data, cut-off 16 Apr 2021

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TACTI-002 Results[(1)] 2[nd] line HNSCC (Part C)

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Best response:
100
iUPD/iCPD
75 iSD
iPR
50
iCR
25
PD-L1 CPS
0
-25
-50
-75
n = 31
-100
- NE - not evaluable; NY - not yet evaluated ** LN as target lesion; *** target
lesion decrease at PD due to NL


8 4 NE NY 1 100 2 7 0 5 5 5 0 7 5 2 5 <5 4 0 4 1 8 5
0 0 0 1 1 1 0 NE 2 8 NY 0 NE 0 4 1 1 NY 0 NY
Best % change from baseline
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100
Best response:
80
iUPD/iCPD
60 iSD
iPR
40
iCR
20
0
-20
-40
-60
-80
-100
0 12 24 36 48 60 72 84 96
cut-off 16-Apr 2021, n=31
weeks
… patients still under therapy
% change compared to start of therapy
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Figure 3: Duration of response (DOR) for confirmed responders

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100
50
DoR HNSCC
N=10
0
0 6 12 18
months
Probability of Survival
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Deep responses with 5 Complete Responses Duration of response (DoR)

• 91% confirmed responses

• 80% confirmed responses ongoing (censoring at 4-20 months)

• No progression prior to 6 months DOR

• Median duration of response cannot be estimated yet

Note:

(1) Preliminary data, cut-off 16 Apr 2021 ** >= 1 post baseline tumor staging (N=31)

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TACTI-002 Results[(1)]

2[nd] line HNSCC (Part C)

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Kaplan-Meier Plot PFS*

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100
90
CPS >=1 (n=24)
80
unselected for PD-L1 (n=37)
70
60
50
40
30
20
10
0
0 6 12 18 24
Probability of Survival
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months

Overall population (unselected for PD-L1)

Selected for PD-L1 expression, CPS ≥ 1 *

• Median PFS 2.1 mths

• 30+% progression free at 6 mths

Median OS (58% events) 12.6 mths Median PFS (71% events) 4.1 mths (45% prog. free at 6 mths) ORR iRECIST (95% CI) 45.8% (25.6-67.2)

Note:

(1) Preliminary data, cut-off 16 Apr 2021 (2) * ≥ 1 treatment and no death due to COVID-19 prior to first post-baseline staging (N=37)

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ORR CR

TACTI-002 Results[(1)]

2[nd] line HNSCC (Part C) – Benchmarking

	PD-L1 (CPS)	Pembro alone**	TACTI-002
ORR (%)	≥ 1	17.3 (2% CR)	45.8 (20.8% CR)
	Overall pop.	14.6	35.5#
mPFS (mths)	≥ 1	2.2 28.7% PFS rate at 6 mths	4.1* 45% PFS rate at 6 mths
	Overall pop.	2.1 25.6% PFS rate at 6 mths	2.1§ 30+% PFS rate at 6 mths
mOS (mths)	≥ 1	8.7 40% alive at 12 mths	12.6* 54% alive at 12 mths
	Overall pop.	8.4 37% alive at 12 mths	12.6§ 50+% alive at 12 mths

• • only patients evaluated where PD-L1 results available (N=24);[#] - only evaluable patients (N=31);

• § - total pop. (N=37) ; ** Data for pembro derived from KN040(2)

• ORR of pembro mono generally low → increase to 22% (≥ 20 CPS) and 28% (≥ 50 CPS)[(3)]

• Duration of response drops dramatically if you add chemo[(4) ] – not the case with efti

• ORR is clearly higher with high rates of CRs; duration of response very promising (only 1 pt. with PR discontinued in TACTI-002 so far)

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TACTI-002 Part C - Historical comparison of ORRs and CRs in metastatic HNSCC for patients who has a PD-L1 CPS of ≥1. ORR for Pembrolizumab monotherapy was taken from KEYNOTE-040.

Notes:

(1) Preliminary data, cut-off 16 Apr 2021 (2) Keynote-040 results: EEW Cohen et al., The Lancet 2018; http://dx.doi.org/10.1016/S0140-6736(18)31999-8 (3) E Cohen et al; Annals of Oncology 2019; Volume 30 | Supplement 5 | September 2019

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Efti + anti-PD-L1 Combination INSIGHT-004 Update from ASCO 2021

INSIGHT Platform Trial in Solid Tumours

INSIGHT-004: Efti + Avelumab Combination

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INSIGHT-004 is a dose escalation study evaluating efti in combination with Bavencio ® (avelumab). Conducted as the 4[th] arm i.e. Stratum D of the INSIGHT trial.

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In collaboration with

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Institut für Klinisch-Onkologische Forschung

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Phase I 12 Open label trial Patients: 2 cohorts of 6 patients each

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6 months One site Combination treatment, Germany then 6 months avelumab monotherapy

Inclusion

Treatment

Results

Solid tumors

• histologically confirmed locally advanced or metastatic

• received ≤ 3 prior lines of therapy

• no selection for immunogenic markers (e.g. PD-L1 expression levels, msi high or tmb)

• 1) Avelumab + Efti (6 mg - 30 mg) s.c. qw 2 for a maximum of 6 months

• 2) Avelumab monotherapy (maintenance) qw 2 for a maximum of further 6 months

RP2D, Safety, ORR, PFS, PK, PD

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INSIGHT-004 (Stratum-D) Results[(1)]

Activity

• 5/12 (42%) with partial responses in different indications:

• 1st line MSI high colorectal cancer; 1st line pleural mesothelioma; after radiochemo in squamous anal cell; pre-treated squamous cervical cancer (PD-L1 TPS < 1%) carcinoma; 3[rd] line gastroesophageal junction

• 75% (n=9) are still alive → 66.7% (n=4) of cohort 1 and 83.3% (n=5) of cohort 2

Best overall response (RECIST 1.1)

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Safety

• Combo of avelumab 800 mg + efti 6 mg or 30 mg efti s.c. is feasible and safe

• No unexpected AEs

Conclusion

• Treatment with efti + avelumab safe, with promising signals of efficacy

• Efti + avelumab seems to be a potent combination for enhancing PD-L1 directed therapy and needs further evaluation in new trials

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Note:

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(1) ASCO 2021: J Clin Oncol 39, 2021 (suppl 15; abstr 2518); DOI 10.1200/JCO.2021.39.15_suppl.2518

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Efti + Chemo Combination AIPAC

Exciting interim OS results presented at SABCS in December 2020 Final OS results to be presented at SITC, 10-14 November 2021

Goal: Improving OS while maintaining QoL in HR[+] /HER2[–] MBC patients

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Epidemiology:

• More than 2 million breast cancer (~70% HR[+] /HER2[--] ) diagnoses per annum worldwide. 1.5 million of which are under the age of 65[(1)]

• Highest incidence rate among cancers: ~25% of all new cancer diagnoses among women and ~12% in the total population, including men.[(1)]

• Up to 350,000 patients younger than 65 develop metastatic disease and are eligible to receive chemotherapy[(1) (2)]

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Market Size:
~USD30 billion [(3)]
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High Unmet Medical Need

Paclitaxel

Lack of Innovation

efti addresses high unmet medical need with a good safety profile

Weekly paclitaxel well established SOC

No innovation in decades & no significant innovations in the pipeline for pts receiving chemo

Notes

MBC – metastatic breast cancer BC – breast Cancer

(1) Source: WHO Global Cancer Observatory 2020 and Informa Intelligence October 2020 (2) Wang et al. BMC Cancer (2019) 19:1091

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Efti: AIPAC (Phase IIb) design

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

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Fact sheet

Primary endpoint[(] *[)] (presented Mar. 2020) included:

• ✓ Conducted in 7 EU countries

• Assessment of Progression-Free Survival (PFS)

Secondary endpoints[(] *[)] (presented Dec. 2020) included:

• ✓ Local and blinded independent central read

• ✓ Last Patient In enrolled Jun. 2019

• Overall Survival (OS)

• Safety and tolerability

• ✓ Primary analysis PFS (immature OS) Mar. 2020

• Overall Response Rate (ORR) and other efficacy parameters

• Biomarker and Immune Monitoring

• ✓ Follow-up 1 analysis OS Sep. 2020 (SABCS Dec. 2020) – ~60% OS events

• ❖ 2[nd] OS follow-up analysis at SITC 2021

Notes:

• No hypothesis testing ORR – overall response rate, DCR – disease control rate, PFS – progression free survival, OS – overall survival, QoL – Quality of life

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AIPAC Phase IIb Clinical Interim OS Results*

Subgroups: low monocytes and < 65 years – PFS / OS / ORR

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For predefined sub-groups:

Clinically meaningful absolute and relative improvement for efficacy parameters, significance for OS ESMO scale of magnitude = level 4 (makes reimbursement very likely)**

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Prior CDK 4/6

Quality of Life (QLQ-C30)

have negative impact on OS in placebo group (median reduced from 20.0 to 14.9 months), but not in the efti group (median OS 20.9 vs. 20.4 months)

Significant deterioration of overall QoL in the placebo group at week 25, which was not observed in the efti group Very important for reimbursement → favorably for efti

CDK4/6 are now standard, and most patients will have received it in future studies / real world → favorably for efti

Notes:

** used for reimbursement in Europe: https://www.esmo.org/guidelines/esmo-mcbs/scale-evaluation-forms-v1.0-v1.1

• These results were presented at SABCS 2020. Data cut-off for interim overall survival results was 24 September 2020.

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AIPAC Phase IIb Clinical Results

Immune Monitoring on Fresh Blood (up to 70 patients)

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Cytotoxic CD8[+] T Cell count over time (Mean + SEM million cells/L of blood; p-value Wilcoxon)

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Number of T cells increased in efti group, especially cytotoxic CD8[+] → Proof of Principle.

Stat. significant (p=0.020) Correlation: OS and cytotoxic CD8[+] T cell count Overall survival (months)

Increased number of cytotoxic CD8[+] T Cells correlated with improved OS in the efti arm → Proof of Concept.

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AIPAC Phase IIb Clinical Results

Summary and Conclusions

First time

an APC activator has shown meaningful increase in Overall Survival (OS) in a randomised setting

Proof of Concept

Prolonged OS in the overall population and clearly linked to pharmacodynamic effect (increase in CD8 T cells)

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Proof of Principle

Significant increase in cytotoxic T cell numbers compared to placebo

Path Forward

Regulatory (FDA and EMA) discussions are prioritised now

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Other Efti Partnerships

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• EOC, an Eddingpharm spin-off holding the Chinese rights for efti, Phase I study in MBC completed with a Phase II trial in preparation

• Milestone and royalty bearing partnership

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• Spin off from NEC, Japan: aims to develop cancer drugs discovered by artificial intelligence → mainly cancer vaccines

• Clinical Trial Collaboration (up to US$5 million for Immutep); Phase I completed

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• Strategic supply partnership for the manufacture of efti

• Through WuXi, Immutep was the first company to use a Chinese manufactured biologic in a European clinical trial

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New Trials

TACTI-003, INSIGHT-003 and INSIGHT-005

TACTI-003 Trial in 1[st] line HNSCC

Design + Status

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In collaboration with

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Design:

• Randomised study with ORR as primary endpoint

• • Sites worldwide (AU, US, Europe)

• • Approx. 154 pts: either to be randomised to have sufficient pts. in each group or in an experimental arm

Status:

• First patient expected in 2H 2021

• ▪ Fast Track designation granted by FDA in April 2021

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INSIGHT Platform Trial in Solid Tumours

Stratum-003: Efti + anti-PD-1 + chemo

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To evaluate the feasibility and safety of triple combination therapy consisting of efti in conjunction with an existing approved standard of care combination of chemotherapy and anti-PD-1 therapy.

Institut für Klinisch-Onkologische Forschung

In collaboration with

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Phase I 20
Open label trial Patients with various
solid tumours First patient
Enrolled and safely dosed
August 2021
6 months
Two sites
Combination treatment,
Germany
then maintenance
monotherapy or
combination
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Inclusion

Solid tumors

• histologically confirmed locally advanced or metastatic

• received no or max. 1 prior lines of therapy

• no selection for immunogenic markers (e.g. PD-L1 expression levels, msi high or tmb)

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Treatment
1) SoC (Chemo + a-PD-1 therapy) + Efti
30 mg s.c., qw 2 for a maximum of 6 mts
2) Maintenance therapy
Dependent on SoC maintenance schedule
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Results
RP2D, Safety,
ORR, PFS, PK, PD
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INSIGHT Platform Trial in Solid Tumours

Stratum-005: Efti + Bintrafusp Alfa Combination

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To evaluate the feasibility and safety of combined treatment with bintrafusp alfa (M7824) and eftilagimod alpha. Conducted as the 5[th] arm of the INSIGHT trial.

In collaboration with

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Institut für Klinisch-Onkologische Forschung

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Bintrafusp alfa: bifunctional fusion protein that aims to block two immunosuppressive pathways: TGF-β and PD-L1

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Efti: LAG-3 fusion protein that activates antigen presenting cells (APCs) via the LAG-3 – MHC II pathway

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Phase I/IIa Open label trial

12 months

Combination treatment

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12 Patients in 3 cohorts

Two sites Germany

Inclusion Treatment

Results

Solid tumors

• histologically confirmed locally advanced or metastatic

• received ≤4 prior lines of therapy

Q2W for maximum of 12 months

• bintrafusp alfa 1.200mg i.v.

• eftilagimod alpha 30mg s.c.

RP2D, Safety, ORR, PFS, PK, PD

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IMP761 - Autoimmune Diseases -

Broad potential in targeting auto-reactive memory T cells with IMP761

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THE PRESENT: FIGHTING THE SYMPTOMS

: Treating general inflammation corticoids, methotrexate, anti-TNF-α, -IL-6, -IL-17, -IL-23 mAbs

THE FUTURE: FIGHTING THE CAUSE : Treating the disease process silencing the few autoimmune memory T cells accumulating at the disease site with IMP761

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POTENTIAL GAME CHANGER IN AUTOIMMUNE DISEASES (US $153.32 billion by 2025)[1]

Notes

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(1) Source: https://www.researchandmarkets.com/reports/4828880/autoimmune-disease-therapeuticsmarket-by-drug

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Out-Licensed Immunotherapy Pipeline & Other Collaborations

Ieramilimab (LAG525) for Cancer

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• Novartis holds an exclusive WW licence to develop and commercialise Ieramilimab (which is derived from Immutep’s antagonist antibody known as IMP701)

• 1st and 2nd milestone payments received by Immutep in August 2015 (undisclosed) and August 2017 (US$1 million)

• In 2018 Novartis cancelled 90 other R&D programs but continued to invest heavily in progressing the development of LAG525[(1)]

• Novartis currently has five clinical trials for Ieramilimab in multiple cancer indications for over 1,000 patients[(2)]

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• Ieramilimab is an anti-LAG-3 mAb that blocks LAG-3-mediated immune down-regulation

• LAG-3 is a prime target for immune checkpoint blockade as it is readily expressed at a high level in many human tumors

Notes

(1) https://www.fiercebiotech.com/biotech/novartis-dumps-20-programs-following-pipeline-review (2) For details on all trials of LAG525 conducted by Novartis see: https://www.clinicaltrials.gov/ct2/results?cond=&term=novartis+lag525&cntry=&state=&city=&dist=

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GSK’781 (IMP731) for Autoimmune Diseases

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• Exclusive WW licence continues with GSK to develop and commercialise GSK’781 (which is derived from Immutep’s depleting antibody known as IMP731)

• Up to ₤64 million in upfront payments and milestones, plus royalties

• GSK portfolio review in 2017 -> GSK’781 continued despite cancellation of 13 clinical and 20 preclinical programs[(1)]

• March 2018: Phase I trial in psoriasis completed in 67 subjects/patients[(2)]

• September 2019: 1[st] patient dosed in Phase II trial in ulcerative colitis in 242 patients triggered a £4 million (~US$5.0 million) milestone payment to Immutep[(2)]

• Phase I clinical study completed, evaluating GSK’781 in 36 healthy Japanese and Caucasian subjects, PK/PD study[(2)]

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• Phase II in Ulcerative Colitis discontinued in January 2021

GSK’s investigational product, GSK2831781, which is derived from IMP731 antibody, aims to kill the few activated LAG-3[+] T cells that are auto-reactive in autoimmune disease leading to long term disease control without generalized immune suppression

Notes

40

(1) https://www.biopharmadive.com/news/glaxosmithkline-gsk-rd-pipeline-restructuring-cut-q2-earnings/447924/ (2) For additional information refer https://www.clinicaltrials.gov/ct2/results?cond=&term=GSK2831781&cntry=&state=&city=&dist=

Collaboration with LabCorp

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• Licence and Collaboration Agreement for immunooncology products or services (entered in Oct 2020)

• Development of lab tests that may help oncologists select the right therapeutic options for their patients

• Upfront and potential commercial milestone and service-related payments to Immutep

Laboratory Corporation of America Holdings (LabCorp) is a leading global life sciences company focused on guiding patient care that provides diagnostic, drug development and technology-enabled solutions for more than 160 million patient encounters per year.

• Immutep selected for its LAG-3 expertise

Enables Immutep to enter the immuno-oncology diagnostics market through its technology and LAG-3 expertise

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Outlook

2021/2022 News Flow*

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H1 2021 H2 2021 2022
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• ✓ Fast Track designation granted for efti in 1[st] line HNSCC from US FDA

• ✓ Data from TACTI-002 & final data from INSIGHT004 at ASCO

• ✓ Expansion of existing programs, adding:

• ✓ Second collaboration with MSD for TACTI-003

• ✓ First triple combination therapy with efti in INSIGHT-003

• ✓ New collaboration with Merck KGaA for INSIGHT-005

• ✓ Patent protection strengthened

• ✓ Financial position significantly strengthened

• ✓ Validation of LAG-3/MHC-II interaction through BMS’s Phase III results in melanoma

• ❑ Final data from AIPAC : 2[nd] OS follow up at SITC

• ❑ Start & ongoing recruitment of new randomised trial in 1st line HNSCC (TACTI-003) in Q3 2021

• ✓ Part B of TACTI-002 fully recruited

• ❑ Recruitment into Part A extension & further data from TACTI-002 in 2021 or early 2022

• ✓ INSIGHT-003 first patient enrolled in Q3 2021 and first interim results in 2022

• ❑ Manufacturing scale up to 2,000 L

• ❑ Ongoing regulatory engagement

• ❑ Updates from IMP761

• ❑ Further updates from partnered programs (e.g. GSK, Novartis, EAT COVID, CYTLIMIC and EOC Pharma)

Notes:

*The actual timing of future data readouts may differ from expected timing shown above. These dates are provided on a calendar year basis. A tick symbol indicates a completed item.

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Corporate Snapshot

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Ticker symbols

IMM (ASX) IMMP (NASDAQ)

Securities on issue[(1)]

~ 850.92 million ordinary shares

Proforma cash balance[(2)] ~ A$114 million (US$85.7 million)

Market Cap[(3)] ~ A$459.50 million (US$335.30 million)

Notes:

• (1) Currently 32.82% of the ordinary shares are represented by ADSs listed on NASDAQ where 1 ADS represents 10 ordinary shares.

• (2) Pro forma cash balance based on Immutep’s cash balance on 30 June 2021 plus the gross proceeds from the SPP and Tranche 2 share issuance as announced to the ASX on 30 July 2021. (3) Market capitalization based on ASX share price of A$0.54 on 24 September 2021 and basic ordinary shares outstanding.

US equivalent of amounts above are based on foreign exchange rate for AUD/USD of 0.7297 for market capitalization, and the US cash & cash equivalents amount was calculated using FX rate of 0.7518.

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Summary

Global leadership position in LAG-3 with 4 LAG-3 related product candidates in immuno-oncology and autoimmune disease

Compelling clinical data from efti & strong rationale to combine with multiple FDA approved treatments

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Multiple active clinical trials (including partnered candidates), with further significant data read-outs expected in 2021 and into 2022

Established collaborations with e.g. Merck (MSD), Pfizer, Merck KGaA, Novartis and GSK

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Thank You