Immutep Ltd · ASX:IMM
Immutep — Investor Presentation (October 2025)
37 slides from Immutep's investor presentation, October 2025
Slide 1: Immutep Corporate Presentation
Immutep Corporate Presentation October 2025 (IMM:ASX, IMMP:NASDAQ) Empowering the immune system to fight cancer and autoimmune disease
Slide 2: Forward Looking Statements
Forward Looking Statements 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 clarificati
Slide 3: Immutep Highlights
Immutep Highlights Four clinical-stage assets designed to safely empower patients’ immune systems to fight cancer A leader in LAG-3 and autoimmune diseases through the MHC Class II & LAG-3 pathways, including first-in-class immunotherapy immunotherapies eftilagimod alfa (efti) and IMP761. Registrati
Slide 4: Deep Clinical Pipeline in Oncology & Autoimmune Diseases
Deep Clinical Pipeline in Oncology & Autoimmune Diseases Information current as of October 2025. 1. Investigator-initiated trial that Immutep has no control over. 2. Three trials for IMP731 were conducted by GSK (two Phase I studies in healthy volunteers and psoriasis and a Phase II study in ulcerat
Slide 5: Oncology
Oncology Eftilagimod Alfa (Efti): Only immunotherapy in clinical development that activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) directly via the MHC Class II pathway to fight cancer Efti: A soluble fusion protein with four extracellular domains of LAG-3 fused to human
Slide 6: Activating a Broad Anti-Cancer Immune Response with Efti
Activating a Broad Anti-Cancer Immune Response with Efti Efti and immature Efti directly activates iDCs by binding to MHC Class II. Then, dendritic cell (iDC) these more mature DCs initiate a broad anti-cancer immune response, including priming & activating cytotoxic T cells as well as generating im
Slide 7: Efti’s Key Attributes and Encouraging KOL Feedback
Efti’s Key Attributes and Encouraging KOL Feedback Efti Key Attributes KOL Feedback on Efti & 1L NSCLC Phase III1,2,3 Ø Real innovation – Efti is a first-in-class asset unlike any Ø Robust fundament in NSCLC – Positive on efti driving in the immunotherapy landscape higher responses & survival in pre
Slide 8: Advantages of Subcutaneous Delivery
Advantages of Subcutaneous Delivery Subcutaneous administration of efti positions it well in current & future cancer treatment landscape Efti’s subcutaneous delivery: • Generates systemic anti-cancer immune response • Improves patient experience vs. intravenous (IV) administration used with other th
Slide 9: Immutep’s Key Value Driver
Immutep’s Key Value Driver First Line Non-Small Cell Lung Cancer (1L NSCLC) • Lung cancer is the leading cause of cancer death and non-small cell lung cancer (NSCLC) comprises 80 to 85% of all lung cancers1,2 • ~2.0 million NSCLC diagnoses annually • Total addressable NSCLC drug market expected to r
Slide 10: High Unmet Need in 1L NSCLC
High Unmet Need in 1L NSCLC Need for IO-combination therapies that maximize the immune system’s ability to fight cancer Evolution of Immunotherapy (IO) in 1L NSCLC Immune Checkpoint Next-generation IO + ICIs + Chemotherapy Inhibitors (ICI) alone ICIs + Chemotherapy ICIs as monotherapies ICIs + chemo
Slide 11: TACTI-002/KEYNOTE-798: Strong Efficacy with Efti + KEYTRUDA
TACTI-002/KEYNOTE-798: Strong Efficacy with Efti + KEYTRUDA In collaboration with Tumour Response by PD-L1 Expression Level1 • Results offer strong evidence of efti’s complementary TPS <1% TPS 1-49% TPS ≥50% effect with PD-1 inhibitors and its unique stimulation of N=32 N=38 N=20 patients’ anti-canc
Slide 12: TACTI-002: Benchmarking Efti + KEYTRUDA to KEYTRUDA Alone
TACTI-002: Benchmarking Efti + KEYTRUDA to KEYTRUDA Alone Objective Response Rate Progression Free Survival Overall Survival Compelling efficacy from efti + KEYTRUDA across all PD-L1 levels including 1L NSCLC patients with negative & low PD-L1, for whom KEYTRUDA monotherapy works sub-optimally* * KE
Slide 13: TACTI-002: Favourable Safety Profile
TACTI-002: Favourable Safety Profile Differentiated overall survival from Efti + KEYTRUDA achieved without foregoing safety Comparison of data is from different clinical trials. 1. Ipilimumab + Nivolumab approved in US for 1L NSCLC PD-L1 TPS >1% but not in EU; Pembro mono not approved in Europe for
Slide 14: INSIGHT-003: High Response Rates Across All PD-L1 Levels
INSIGHT-003: High Response Rates Across All PD-L1 Levels Benchmarking Efti + KEYTRUDA + Chemo Objective Response Rate to KEYTRUDA + Chemo 75.0 75 70 68.0 • Promising efficacy from efti + KEYTRUDA + chemo 65 62.1 in non-squamous 1L NSCLC across all PD-L1 levels 60 54.5 • 61.7% ORR in TPS <50% (N=47)
Slide 15: INSIGHT-003 Case Study: Patient with PD-L1 TPS 0%
INSIGHT-003 Case Study: Patient with PD-L1 TPS 0% Baseline After 1 Year of Therapy September 2024 September 2025 Case study of a 75-year-old male TL1 TL1 with partial response (PR): Lung: Lung: 27 mm 7 mm • PD-L1 TPS 0%, no actionable genetic alterations • TTF1 pos. Adeno-Carcinoma, G3 • ECOG PS 1 •
Slide 16: INSIGHT-003: Excellent PFS & Overall Survival
INSIGHT-003: Excellent PFS & Overall Survival Complementary effect from the combination of Efti + KEYTRUDA + Chemo Overall Survival Progression Free Survival TPS 0-100% TPS 0-100% 35 32.9 14 12.7 • Excellent OS & PFS in patients with a minimum 30 12 follow-up of 22 months (N=21), well above historic
Slide 17: Efti with KEYTRUDA Expands ORR & Enhances PFS/OS
Efti with KEYTRUDA Expands ORR & Enhances PFS/OS Efti + KEYTRUDA without chemo and with chemo has safely led to compelling ORR, PFS, and OS well above KEYTRUDA +/- chemo in two 1L NSCLC trials that together have enrolled >165 patients Addition of chemo enhances strong efficacy achieved in TACTI-002
Slide 18: TACTI-004/KEYNOTE-F91 Phase III Trial in 1L NSCLC
TACTI-004/KEYNOTE-F91 Phase III Trial in 1L NSCLC In collaboration with • Third collaboration & supply agreement with MSD - who jointly designed registrational TACTI-004 trial with Immutep - announced in June 2024. • 1:1 randomized, double-blind, global trial enrolling ~756 patients in +150 sites ac
Slide 19: TACTI-004 Milestones and Multiple Potential Paths to Success
TACTI-004 Milestones and Multiple Potential Paths to Success TACTI-004/KN-F91 Milestones 1st Patient in: Futility Interim 25 March 2025 Analysis Analysis: PFS* Q2’25 Q3’25 YE’25 Q1’26 Q2’26 Q3’26 YE’26 Q1’27 Q2’27 * Potential filing if positive Dual Primary Endpoints: • Progression-free Survival TAC
Slide 20: Global Phase III Landscape for Advanced/Metastatic 1L NSCLC
Global Phase III Landscape for Advanced/Metastatic 1L NSCLC Companies that have a CTCSA with MSD for No PD-L1 Low PD-L1 High PD-L1 Non- % of 1L NSCLC Squamous Phase III trials in advanced/metastatic 1L NSCLC1 TPS <1% TPS 1-49% TPS >50% Squamous Population % of 1L NSCLC patient population by segment2
Slide 21: Potential Blockbuster Commercial Opportunity
Potential Blockbuster Commercial Opportunity If TACTI-004 is successful it presents a potential multi-billion US$ opportunity 1L NSCLC for efti as it will be a safe add-on to KEYTRUDA & chemo in 1L NSCLC: • KEYTRUDA has revolutionized treatment landscape and MSD captures 7 to 8 of every 10 metastati
Slide 22: Efti’s Potential to Extend IP for PD-1 Inhibitors
Efti’s Potential to Extend IP for PD-1 Inhibitors 2024 Sales of Anti-PD-(L)1 Therapies ($ Billions) 30 29.5 25 • Efti’s comprehensive patent portfolio provides an opportunity to enhance and substantially extend 20 established or new PD-(L)1 franchises 15 • Two leading PD-1 inhibitors, KEYTRUDA & OPD
Slide 23: Additional Oncology Indications
Additional Oncology Indications Efti’s favorable safety profile & unique activation of immune system allows for multiple combinations in various cancers • Metastatic Settings: • Head and Neck Cancer: Efti + Anti-PD-1 • Breast Cancer: Efti + Chemotherapy • Urothelial Carcinoma: Efti + Anti-PD-L1 • Ne
Slide 24: TACTI-003: Strong Chemo-Free Results in 1L HNSCC w/ CPS <1
TACTI-003: Strong Chemo-Free Results in 1L HNSCC w/ CPS <1 In collaboration with Benchmarking to Efti + KEYTRUDA to KEYTRUDA with/without chemo in PD-L1 expression below 1 (CPS <1) 24 Comparison of data is from different clinical trials with pembrolizumab monotherapy and with chemotherapy from KN-04
Slide 25: Limited Competition in 1L HNSCC CPS <1: A Valuable Market
Limited Competition in 1L HNSCC CPS <1: A Valuable Market Next Steps in 1L HNSCC CPS <1 In August 2025, Immutep announced positive FDA feedback on late-stage Standard-of-Care (SOC) Ongoing Clinical Trials clinical development of efti in 1L HNSCC Therapies include Chemo without Chemo patients with CP
Slide 26: Primary Endpoint Met in Phase II Trial in Soft Tissue Sarcoma
Primary Endpoint Met in Phase II Trial in Soft Tissue Sarcoma ESMO Congress 2025 – Proffered Paper Oral Presentation Neoadjuvant efti + KEYTRUDA + radiotherapy met primary endpoint with median 51.5% Hyalinization/Fibrosis Viable Tumour Cells tumour hyalinization/fibrosis (p<0.001)1 in patients with
Slide 27: AIPAC-003 Trial in Metastatic Breast Cancer
AIPAC-003 Trial in Metastatic Breast Cancer • HR+/- HER2-negative/low and triple negative metastatic breast cancer (MBC) patients represent ~78% breast cancer cases1 • Patients receive efti + paclitaxel on same day; IO-chemo treatment can continue until disease progression • Trial design incorporate
Slide 28: Neoadjuvant Efti in HR+/HER2-neg Breast Cancer Phase II Trial
Neoadjuvant Efti in HR+/HER2-neg Breast Cancer Phase II Trial Phase II: Overview & Trial Design • George Washington (GW) Cancer Center initiating Phase II evaluating neoadjuvant efti as monotherapy and with chemo prior to surgery in HR+/HER2-neg breast cancer patients • Study primarily funded by gra
Slide 29: Efti + Anti-PD-L1 (Avelumab) in Metastatic Urothelial Cancer
Efti + Anti-PD-L1 (Avelumab) in Metastatic Urothelial Cancer • INSIGHT-005 evaluating safety & efficacy of efti and avelumab (BAVENCIO®), In collaboration with which has previously shown promising efficacy in solid tumours in Phase I trial • Jointly funded by Immutep & Merck KGaA, Darmstadt, Germany
Slide 30: Autoimmune Diseases
Autoimmune Diseases IMP761: First-in-class immunotherapy is a LAG-3 agonist antibody designed to target the root cause of many autoimmune disorders IMP761: A LAG-3 agonist antibody
Slide 31: Targeting Autoimmune Diseases with a LAG-3 Checkpoint Agonist
Targeting Autoimmune Diseases with a LAG-3 Checkpoint Agonist New paradigm to treat the cause - as opposed to the symptoms - of autoimmune disorders “Findings further support the potential clinical benefits of a LAG-3 agonist in Unique advantages of LAG-3 allow for a more the treatment of human auto
Slide 32: IMP761: First-in-Class LAG-3 Agonist a Potential Game-Changer
IMP761: First-in-Class LAG-3 Agonist a Potential Game-Changer IMP761 increases “brake” function of the LAG-3 immune checkpoint and its natural down-regulation of auto-reactive memory IMP761 T cells, which represent the root cause of LAG-3 Suppress many disorders. LAG-3 proliferation, Antigen- activa
Slide 33: IMP761: Strong Inhibition of TCR Signalling & T Cell Activation
IMP761: Strong Inhibition of TCR Signalling & T Cell Activation • Unlike 100+ inhibitory receptors including PD-1, LAG-3 has no tyrosine-based ITIM motif in its cytoplasmic domain1 • Inhibitory motifs unique to LAG-3 explain in part clear & rapid inhibition of T cell receptor (TCR) signalling induce
Slide 34: First-in-Human Phase I Trial of IMP761
First-in-Human Phase I Trial of IMP761 World-class research institute, CHDR, appointed to conduct first-in-human study Overview / Key Milestones: • Placebo-controlled, double-blind Phase I (N = 49) • Centre for Human Drug Research (CHDR) in Leiden, the Netherlands, conducting study in healthy volunt
Slide 35: Upcoming Milestones
Upcoming Milestones • Non-Small Cell Lung Cancer – TACTI-004 futility analysis in Q1 2026 • Soft Tissue Sarcoma – Update from EFTISARC-NEO Phase II in November at CTOS 2025 • Head and Neck Squamous Cell Carcinoma – Ongoing evaluation of potential options for collaborative clinical development & path
Slide 36: Summary
Summary • Immutep is a leader in immunotherapy with substantial opportunity in both oncology & autoimmune disease Phase III in 1L NSCLC with • Efti is the only immunotherapy that directly activates APCs via MHC Class II multi-billion US$ pathway and has significant potential to redefine cancer treat
Slide 37: Thank You
Thank You Empowering the Immune System