IMMUTEP LIMITED — AGM Information 2024

Nov 21, 2024

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Immutep AGM 2024 Presentation 22 November 2024 (ASX: IMM; NASDAQ: IMMP)

Unlocking the power of the immune system to fight cancer and autoimmune disease

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 is authorised for release by the CEO of Immutep Limited.

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Agenda
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Overview of Immutep Highlights & Outlook Efti Program & Strategy IMP761 Program Summary

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Overview of Immutep

Company Overview

• Multiple LAG-3 Programs – Four clinical-stage assets and one preclinical program

Pure-play LAG-3 company with deep pipeline in oncology & autoimmune diseases:

• Upcoming Milestones – Multiple data updates from clinical programs

• First-in-class MOA – As unique MHC Class II agonist, efti activates innate and adaptive anti-tumor immunity

Lead candidate Efti addressing therapeutic gaps across the solid tumor treatment landscape:

• Activity across PD-L1 spectrum – Activity in hot/tepid/cold tumors addressing high unmet needs

• Consistent Outcomes – Improved survival across multiple indications with mature data

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Efti-IO Efti-Chemo Combination Combination

• Favourable Safety – Well-tolerated profile with standard-of-care IO and/or chemotherapy

Strong IP/Balance Sheet:

• Manufacturing – Achieved 2000L commercial scale production; authorization for clinical trial use granted in Sept ’23

• Intellectual Property – Comprehensive IP portfolio; innovative biologics also potentially entitled to test data exclusivity (e.g., up to 12 years in US)

Efti-IO-Chemo Combination

• Well-Financed – Cash, cash equivalent and term deposit position totalling ~A$172.3 million[1] providing expected runway to end of 2026

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1. As at 30 September 2024

Deep LAG-3 Pipeline in Oncology & Autoimmune Diseases

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		Program	Indication	Preclinical	Phase I	Phase II	Late Stage#	Collaborations	Commercial Rights
		Global Rights TACTI - 003	Efti + Pembrolizumab a TACTI - 002	Efti + Pembrolizumab a EFTISARC - NEO	Efti + Pembro + Radiotherapy § AIPAC - 003	Efti + Paclitaxel Efti + Paclitaxel and Efti + Pembrolizumab ## Efti China Rights Solid Tumors & Blood Cancer Triple Negative Breast Cancer Melanoma Triple Negative Breast Cancer Solid Tumors Global Rights Undisclosed Ulcerative Colitis Psoriasis Healthy Subjects Undisclosed Urothelial Cancer Metastatic Breast Cancer & Solid Tumors Soft Tissue Sarcoma INSIGHT - 003	Efti + Pembrolizumab + Chemo § 1L Non-Squamous NSCLC HR+/HER2-Metastatic Breast Cancer & TNBC 1L NSCLC, 2L HNSCC, PD-X Refractory 2L NSCLC 1L Head & Neck Squamous Cell Carcinoma (HNSCC) Eftilagimod Alfa Soluble LAG-3 Protein & MHC Class II agonist LAG525 Anti-LAG-3 Antibody IMP731 Depleting LAG-3 Antibody IMP761*** Agonist LAG-3 Antibody Anti-LAG-3 Small Molecule Global Rights ex-China INSIGHT - 005	Efti + Avelumab § , b TACTI - 004	Efti + Pembrolizumab + Chemo a 1L Non-Small Cell Lung Cancer (NSCLC) Global Rights
ONCOLOGY
AUTOIMMUNE DISEASE

Information current as of September 2024. For EOC’s China rights, Immutep may receive undisclosed milestones plus royalties; LAG525 (ieramilimab)- ClinicalTrials.gov (for Novartis’ global rights, Immutep may receive milestones plus royalties); Immutep has no control over 6 the trials.[§] Investigator Initiated Trials controlled by lead investigator & therefore Immutep has no control over these clinical trials.[a] In combination with KEYTRUDA[®] .[b] In combination with BAVENCIO[®] . # Late stage refers to active Phase IIb clinical trials or more clinically advanced clinical trials. ## Conducted by EOC in China.* IMP731 - The clinical-stage asset GSK’781 is being transitioned back to Immutep as the licensing agreement has been terminated with an effective date of 30 May 2024. ** IMP761 – Phase I study to launch mid-CY2024.

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Pioneering LAG-3 Immunotherapy Portfolio

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LAG-3
-
Antigen presenting
cells (APC)
MHC
Class II
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Immutep has designed multiple first-in-class therapeutics targeting either MHC Class II molecules on antigen-presenting cells (APC) or LAG-3 on T-cells to fight cancer & autoimmune disease

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-
Targeting MHC Class II on APCs Targeting LAG 3 on T cells
Efti LAG525 [] Anti-LAG-3 IMP731 [] IMP761
Soluble LAG-3 Blocking LAG-3 small molecule Depleting LAG-3 Agonist LAG-3
fusion protein antibody antibody antibody
Oncology Oncology Autoimmune Disease
Immune Stimulation Immune Stimulation Immune Suppression
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MHC Class II = Major Histocompatibility Complex Class II. * LAG525 (leramilimab) is out-licensed to Novartis. The clinical-stage asset GSK’781 (IMP731) is being transitioned back to Immutep as the licensing agreement has been terminated with an effective date of 30 May 2024.

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Highlights & Outlook

2024 Clinical Milestones

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Head and neck squamous cell carcinoma

Non-small cell lung cancer

TACTI-004

TACTI-003

Phase III TACTI-004 trial (KEYNOTE-PNC-91) tests efti in combination with KEYTRUDA® and chemotherapy in ~750 first-line metastatic NSCLC patients regardless of PDL1 expression

Phase IIb TACTI-003 trial evaluating efti in combination with KEYTRUDA® in first-line recurrent/metastatic HNSCC, with 171 patients enrolled across 30 countries

• Achieved a 34.5% ORR across all patients, with PD-L1 and strong DOR and DCR, and a 35.5% ORR in PD-L1-negative patients— outperforming anti-PD-1 monotherapy

• Advanced preparations for the trial, including productive interactions with regulatory agencies and other stakeholders

• Signed third clinical trial collaboration with MSD, receiving its key drug KEYTRUDA at no cost, while retaining commercial rights to efti

• Data presented at ESMO Virtual Plenary session and ESMO annual conference

• FDA Fast Track designation in 1L HNSCC

• Study start in late CY2024 or Q1 CY2025

INSIGHT-003

• Very encouraging mOS data (32.8 m) released from first 21 patients

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Metastatic breast cancer

AIPAC-003

AIPAC-003 is an integrated Phase II/III trial evaluating efti in combination with chemotherapy (paclitaxel) for metastatic HER2-neg/low breast cancer and triplenegative breast cancer, which account for ~78% of breast cancer cases

• Encouraging efficacy, safety, and pharmacodynamic data reported from the six patients in the safety lead-in phase

• Patient recruitment finished in the randomised Phase II part

• Data collection and cleaning ongoing with the main task to identify the OBD

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Soft tissue sarcoma

EFTISARC-NEO

Phase II, open-label trial, examining the combination of efti, radiotherapy and KEYTRUDA in up to 40 patients with soft tissue sarcoma (STS) in the neoadjuvant setting (before surgery)

• Initial efficacy data very encouraging and presented at a conference (first 21 patients)

• Recruitment ongoing

Autoimmune disease

IMP761

First-in-human Phase I clinical trial of IMP761 in healthy volunteers

• 55% ORR from 40 patients

• Recruitment ongoing

• Toxicology trial completed

• Dosed first patient, recruitment ongoing

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TACTI-004 Trial: Immutep & MSD Phase III Trial in NSCLC

Opportunity to set a new standard of care across entire NSCLC population regardless of PD-L1 expression

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Trial Overview:

• TACTI-004 will be a 1:1 randomized, double-blind, multinational, controlled clinical study with ~750 patients

• Trial will enroll first line squamous and non-squamous NSCLC patients who are unselected for PD-L1 expression

• Dual primary endpoints will be Progression-Free and Overall Survival with both being adequately powered

Key Milestones:

• Study start expected in Q4 2024 / Q1 2025

• Futility analysis expected in late 2025 / early 2026 and interim analysis in late 2026 till mid-2027 (event driven)

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• Timelines are indicative and subject to change

INSIGHT-003: Excellent Mature Survival Data

Promising efficacy & safety from first-in-human study evaluating Efti + KEYTRUDA + doublet chemo

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• Investigator-initiated Phase I study in first line metastatic non-squamous NSCLC regardless of PD-L1 (TPS 0-100)

• Multi-centre trial led by the Frankfurt Institute of Clinical Cancer Research (IKF)

• Completion of patient enrollment expected in Q1’2025

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Progression Free Survival Overall Survival
>5050 TPS 0-100 TPS 0-100
75.0 14 35 32.9
12.7
12 30
62.1
10 25
9.0 22.0
8 20
6 15
4 10
2 5
0 0
Efti + Pembrolizumab + chemo Pembrolizumab + chemo
Time (months) Time (months)
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Objective Response Rate
`. TPS <1 TPS 1-49 TPS >5050
80 75.0
70
62.1
58.8
60
49.2
50 47.4
40
32.3
30
20
10
0
Response Rate (%)
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1. Shirish Gadgeel et al., Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non–Small-Cell Lung Cancer. JCO 38, 1505-1517(2020). DOI:10.1200/JCO.19.03136. 2. Data cut-off date is 15 October 2024 for INSIGHT-003. 3. Of note, INSIGHT-003 has ~19% patients with high PD-L1 (who typically respond better to anti-PD-1) vs ~32% patients in historical control.

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Soft Tissue Sarcoma: Orphan Disease with High Unmet Need

Investigator-initiated trial studying novel triple combination of Efti + Radiotherapy + KEYTRUDA

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EFTISARC-NEO Phase II Trial Design[*]

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Screening Study treatment Follow up
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• First trial studying efti in neoadjuvant setting and with radiotherapy

• Importantly, study will provide access to tumor tissue prior to and after treatment, so tumor microenvironment can be assessed[**]

• Cost-efficient Phase II study funded by grant from Polish government

• Completion of patient enrollment expected in Q1’2025

Rationale for triple combination based on cancer-immune cycle[*]

Positive data from EFTISARC-NEO presented at CTOS 2024:

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• ✓ Based on preliminary analysis among 21 patients available for primary endpoint assessment, triple combination with efti demonstrates significant efficacy

• ✓ Median 50% tumour hyalinization (primary endpoint and important predictor of overall survival) is greater than 3-fold increase versus historical median 15% from radiotherapy alone

• ✓ 71.4% of patients achieved pathologic response defined as ≥35% of hyalinization/fibrosis

• ✓ 9.5% of patients achieved a complete pathologic response

• ✓ Therapy well tolerated

• *Pembrolizumab in combination with eftilagimod alpha and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas - EFTISARC-NEO trial – Trial in Progress Poster at ESMO 2023. ** Blood samples and tumor biopsies will be taken for translational studies.

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Commercial Manufacturing & Patent Protection

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Manufacturing at Commercial Scale

Robust Intellectual Property Protection

• Comparability of Drug Substance and Drug Product manufactured at 2,000L scale achieved

• Regulatory authorisation for efti manufactured at commercial 2,000L scale

• Enables use in clinical trials across multiple European countries and the United States

• Follows successful scale up of the manufacturing process from the 200L process to 2,000L at WuXi Biologics

Efti

• Eight new patents granted in FY24:

• Protects combinations with chemotherapy or anti-PD-1 therapy in Europe, Korea and Brazil

• Patent for Immutep’s binding assay for determining MHC Class II binding activity in Brazil, Canada, India, Macao, and Russia

• Broad protection for efti across a total of 9 patent families

IMP761

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• Two new patents granted in FY24 in Australia and Mexico

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FY24 Financial Summary

• Strong cash position of approx. A$172.3 million including investment in term deposit as of 30 Sept 2024 following A$100.2 million equity raise in June 2024

• Disciplined cash management strategy with focus on the development strategy for efti and IMP761

• Total revenue and other income were A$7.8 million in FY24 compared to A$5.2 million in FY23

• Research and development and intellectual property expenses increased to A$41.5 million in FY24 due to clinical trial activity and associated expenses

• Increases in clinical trial costs drove the increase in R&D expenses and the net loss

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	FY24	FY23
Revenue and other income	A$7.8M	A$5.2M
G&A Expenses	A$8.9M	A$8.7M
R&D and IP expenses	A$41.5M	A$36.3M
Net loss	A$42.7M	A$39.9M
Net operating cash outflow	A$34.8M	A$35.4M
Cash and cash equivalents at the end of the financial year	A$181.8 M	A$123.4M
Cash and cash equivalents at 30 September	A$172.3M	A$110.1M

Strong cash runway expected to end of CY2026*

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• As reported in Immutep Quarterly Activities Report on 29 October 2024.

Outlook

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2024

• –

• Non-Small Cell Lung Cancer TACTI-004 preparations for study start in late 2024 / early 2025

• –

• Head and Neck Squamous Cell Carcinoma Update from Cohort B of TACTI-003 trial at the ESMO Immuno-Oncology Congress

• –

• Autoimmune Diseases Safety data from IMP761 first-in-human Phase I trial anticipated by year-end

2025

• Non-Small Cell Lung Cancer – Potential futility analysis in TACTI-004 Phase III trial by year end 2025; update from INSIGHT-003 trial

• –

• Metastatic Breast Cancer Update from AIPAC-003 trial

• –

• Head and Neck Squamous Cell Carcinoma Update from TACTI-003 trial

• –

• Soft Tissue Sarcoma Update from investigator-initiated EFTISARC-NEO trial

• –

• Metastatic Urothelial Carcinoma Update from investigator-initiated INSIGHT-005 trial

• –

• Autoimmune Diseases Update from IMP761 first-in-human Phase I trial

• –

• Additional Updates From ongoing clinical trials, partnered programs, and potential expansion of clinical trial pipeline

• –

• Well-Funded Cash, cash equivalent and term deposit totalling ~A$172.3 million (~US$119.1 million)[1] ; runway expected to end of CY2026

15 1. As at 30 September 2024

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Thank You