Immutep Ltd · ASX:IMM
Immutep — Investor Presentation (May 2023)
63 slides from Immutep's investor presentation, May 31, 2023
Slide 1: Unlocking the power of the immune system to fight cancer and autoimmune disease
Not for release to US wire services or distribution in the United States For personal use only Unlocking the power of the immune system to fight cancer and autoimmune disease. I Investor Presentation – May 2023 (ASX: IMM, NASDAQ: IMMP)
Slide 2: Disclaimer and Important Notice
Disclaimer and Important Notice The following notice and disclaimer applies to this investor presentation (Presentation) and you are therefore advised to read this carefully before reading or making any other use of this Presentation or any information contained in this Presentation. By accepting th
Slide 3: Disclaimer and Important Notice
Disclaimer and Important Notice Not an offer This Presentation is for information purposes only and is not a prospectus, disclosure document, product disclosure statement or other offering document under Australian law or any other law (and will not be lodged with the Australian Securities and Inves
Slide 4: Disclaimer and Important Notice
Disclaimer and Important Notice Investment risk An investment in New Shares is subject to known and unknown risks, some of which are beyond the control of the Company, including possible delays in repayment and loss of principal and income invested. The Company does not guarantee any particular rate
Slide 5: Forward Looking Statements and Forecasts
Forward Looking Statements and Forecasts This Presentation contains certain "forward-looking statements" that are based on management's beliefs, assumptions and expectations and on information currently available to management. Forward- looking statements can generally be identified by the use of fo
Slide 6: Immutep Highlights
Immutep Highlights For personal use only IMM science and Compelling Validation through Capital raising to Substantial market Key catalysts advanced pipeline clinical data partnerships fund late-stage trials opportunity ahead Pioneering LAG-3 Eftilagimod alpha (efti) Multiple partnerships & Undertaki
Slide 7: Deep Pipeline
Deep Pipeline Immutep’s pipeline comprises multiple platforms, pursuing a range of indications with significant milestones anticipated in the next 12 months Program Indication Preclinical Phase I Phase II Late Stage* Collaborations Commercial Rights For personal use only 1L Head & Neck Squamous Cell
Slide 8: Progressing Towards Three Registration Stage Clinical Trials in Large Oncology Indications
Progressing Towards Three Registration Stage Clinical Trials in Large Oncology Indications Immutep has 3 main clinical programs with lead asset Eftilagimod Alpha (“Efti”) progressing into late/registrational stage trials in large oncology indications (NSCLC, HNSCC, MBC) For personal use only Anticip
Slide 9: Well Positioned for Partnering with Large Pharmaceutical Companies
Well Positioned for Partnering with Large Pharmaceutical Companies With compelling safety and efficacy data, strong IP and easy route of administration, Immutep believes it is well positioned to partner with large pharmaceutical companies* For personal use only Pharmaceutical company criteria Commen
Slide 10: Immuno-Oncology (IO) Landscape
Immuno-Oncology (IO) Landscape LAG-3 is one of three Immune Checkpoints with Regulatory Approvals Timeline of Immune Checkpoint Discovery* Evolution of Immuno-Oncology Therapies** For personal use only OPDIVO & KEYTRUDA OPDIVO & Yervoy & chemo Relatlimab (anti-LAG-3) Yervoy OPDIVO (anti-CTLA-4) (ant
Slide 11: Immutep's Pioneering Immunotherapies
Immutep’s Pioneering Immunotherapies Only company with four different therapeutic approaches around LAG-3 and MHC Class II interaction Targeting MHC Class II on APCs Targeting LAG-3 on T cells For personal use only Antigen- with Eftilagimod Alpha (Efti) Presenting T-cell with Agonist/Antagonist Anti
Slide 12: Substantial Commercial Opportunity
Substantial Commercial Opportunity Immutep believes Efti’s ability to safely improve clinical outcomes of anti-PD-(L)1 therapies across the For personal use only entire PD-L1 spectrum in multiple solid tumors* drives substantial commercial opportunity. Efti + Anti-PD-(L)1 Anti-PD-11 Anti-PD-L11 • Do
Slide 13: Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung Cancer (NSCLC) For personal use only SITC 2022 – Dr. Wade Iams presenting 1L NSCLC data from ASCO 2022 - Dr. Enriqueta Felip presenting 1L NSCLC TACTI-002/KN-798 in Late Breaking Abstract Oral Presentation data from TACTI-002/KN-798 in Oral Presentation
Slide 14: 1st line Non-Small Cell Lung Cancer Epidemiology & Unmet Need
1st line Non-Small Cell Lung Cancer Epidemiology & Unmet Need 1L NSCLC Epidemiology1,2 • Lung cancer is one of the leading causes of cancer death • For personal use only About 80% to 85% of lung cancers are non-small cell lung cancer (NSCLC) • Total addressable market (TAM) of NSCLC drug market is e
Slide 15: TACTI-002 Trial Overview and Baseline Characteristics
In collaboration with 1st line Non-Small Cell Lung Cancer TACTI-002 Trial Overview and Baseline Characteristics Trial Design • Phase II For personal use only • Six countries (US, UK, ES, PL, UA, AU) • Open label • 114 patients enrolled with 1L NSCLC (Part A) Baseline characteristics (1L NSCLC) Basel
Slide 16: Encouraging Overall Response Rate in PD-L1 all comer population
1st line Non-Small Cell Lung Cancer (Part A, TACTI-002) Encouraging Overall Response Rate in PD-L1 all comer (TPS 0 – 100%) population For personal use only ORR – PD-L1 all comer (PD-L1 TPS 0 – 100%) Response iRECIST4 n (%) • 40.4% ORR exceeded Primary Objective (ORR > 35%) Complete Response 1 (0.9)
Slide 17: Deep and Durable Responses Translating Into Excellent Overall Survival
1st line Non-Small Cell Lung Cancer (Part A, TACTI-002) Deep and Durable Responses Translating Into Excellent Overall Survival PD-L1 TPS 0 – 100% Key takeaways Deep and durable responses across all PD-L1 levels1 Interim Median Duration of Response (DoR)2,3 120 100 For personal use only Response (%)(
Slide 18: Safety (Part A, TACTI-002)
Safety (Part A, TACTI-002) General overview of AEs For personal use only • Treatment with efti plus pembrolizumab is safe and very well-tolerated • Rate of discontinuation due to drug related adverse events less than 10% and comparable to pembrolizumab monotherapy Frequent AEs (incidence ≥10%) relat
Slide 19: Development Strategy in 1st Line NSCLC: Benchmarking to Pembrolizumab Monotherapy
Development Strategy in 1st Line NSCLC (Part A, TACTI-002) Benchmarking to Pembrolizumab Monotherapy Pembro mono Efti + pembro For personal use only mOS ORR mPFS (TPS ≥1%) (TPS ≥1%) (TPS ≥1%) PD-L1 TPS ≥1% Efti + Pembro Pembro mono Median Overall Survival 25.0 months 16.4 months (mOS) Overall Respon
Slide 20: Strong Initial Overall Survival Benefit (Part A, TACTI-002)
Strong Initial Overall Survival Benefit (Part A, TACTI-002) Efficacy of efti + pembro vs. selected Standard-of-Care in patients with 1st line NSCLC and TPS ≥1% Response Rate Progression Free Survival Duration of response AEs leading For personal use only Therapy Median OS2 (RR) (mPFS) (DOR) to disc.
Slide 21: Treatment Landscape 1st line NSCLC for TPS ≥1%
Treatment Landscape 1st line NSCLC for TPS ≥1% IO-based approaches based on ESMO / NCCN (1) Stage IV NSCLC: Molecular Test Negative (ALK/BRAF/EGFR/ROS1), PS 0-1 For personal use only Treatment decision usually based on PD-L1 expression PD-L1 ≥ 50% PD-L1 ≥1-49% anti-PD-1/PD-L1 anti-PD-1/PD-L1 anti-PD
Slide 22: TACTI-004 Phase III Registration Study – 1st line NSCLC
TACTI-004 Phase 3 REGISTRATION Study – 1st line NSCLC Design based on FDA feedback* Design Details • 2 : 1 randomized, multi-national, open label Phase 3 Patients with PD-L1 TPS ≥1% For personal use only with futility analysis stratified by 1-49% / ≥50% and NSQ / SQ • Sample size app. 630 pts • Prim
Slide 23: IO-IO-Chemo Combination Trial (INSIGHT-003) in 1L NSCLC
IO-IO-Chemo Combination Trial (INSIGHT-003) in 1L NSCLC Promising initial efficacy & safety from first-in-human study evaluating efti + anti-PD-1 + doublet chemo1 INSIGHT-003: Phase I in 1st line Non-Small Cell Lung Cancer INSIGHT-003 - Third arm (Stratum C) of investigator-initiated study For perso
Slide 24: Head and Neck Cancer
For personal use only Head and Neck Cancer - Data presented at ASCO 2023 -
Slide 25: 2nd Line Head & Neck Squamous Cell Carcinoma
2nd Line Head & Neck Squamous Cell Carcinoma Strong, Long-Lasting Efficacy with Favorable Safety Profile. Positive Benchmarking to Pembro mono. TACTI-002/KEYNOTE-798: 2nd Line Head & Neck Squamous Cell Carcinoma (Part C) For personal use only Deep, durable responses from efti + pembro across More th
Slide 26: Efficacy Endpoints Across PD-L1 Subgroups in 2nd line HNSCC
Efficacy Endpoints Across PD-L1 Subgroups in 2nd line HNSCC Encouraging Overall Survival, Progression-Free Survival, and Duration of Response TACTI-002/KEYNOTE-798: 2nd Line Head & Neck Squamous Cell Carcinoma (Part C) For personal use only Efti + Pembro Efti + Pembro Efti + Pembro Pembro Mono** Ove
Slide 27: Ongoing Phase IIb Trial in 1st Line Head & Neck Squamous Cell Carcinoma
Ongoing Phase IIb Trial in 1st Line Head & Neck Squamous Cell Carcinoma (with Fast Track Designation) TACTI-003: Phase IIb in 1st Line Head and Neck Squamous Cell Carcinoma (1L HNSCC) TACTI-003 - Randomized Phase IIb Trial in 1L HNSCC patients utilizing For personal use only Efti + pembrolizumab ver
Slide 28: Metastatic Breast Cancer
For personal use only Metastatic Breast Cancer
Slide 29: Efti Well Positioned to Enhance Standard-of-Care Chemotherapy in Metastatic Breast Cancer
Efti Well Positioned to Enhance Standard-of-Care Chemotherapy in Metastatic Breast Cancer AIPAC Phase IIb: Active Immunotherapy (Eftilagimod Alpha) and PAClitaxel (double blind, 1: 1 randomized study with 226 patients) The broad immune response driven by efti’s activation of antigen-presenting cells
Slide 30: Phase II/III Trial Underway in Metastatic Breast Cancer
Phase II/III Trial Underway in Metastatic Breast Cancer AIPAC-003: Active Immunotherapy (Eftilagimod Alpha) and PAClitaxel AIPAC-003: Integrated Phase II/III trial in Metastatic Breast Cancer (MBC) initiated in March 2023 For personal use only • Builds on positive results from AIPAC Phase IIb trial
Slide 31: Other Oncology Indications
For personal use only Other Oncology Indications
Slide 32: Efti + Anti-PD-L1 (Avelumab) in Urothelial Cancer & Advanced Solid Tumors
Efti + Anti-PD-L1 (Avelumab) in Urothelial Cancer & Advanced Solid Tumors INSIGHT-004: Phase I in Various Advanced Solid Tumors & INSIGHT-005: Phase I in Metastatic Urothelial Cancer For personal use only INSIGHT-004 – Phase I dose escalation study in advanced INSIGHT-005 - Phase I study in metastat
Slide 33: Soft Tissue Sarcoma: Orphan Disease with High Unmet Need
Soft Tissue Sarcoma: Orphan Disease with High Unmet Need Investigator-Initiated Trial Studying Novel Triple Combination of Efti + Radiotherapy + KEYTRUDA EFTISARC-NEO: Open-label Phase II trial in Soft Tissue Sarcoma (STS) For personal use only • Novel triple combination of efti with radiotherapy an
Slide 34: Preclinical Programs
For personal use only Preclinical Programs
Slide 35: Novel Small Molecule Anti-LAG-3 Collaboration
Novel Small Molecule Anti-LAG-3 Collaboration For personal use only Collaboration established in 2019 combining Immutep’s deep LAG-3 biology experience and expertise of world leading scientists at Cardiff University “We are delighted to collaborate with Immutep on this important project to develop a
Slide 36: Targeting the Causes of Autoimmune Diseases
Targeting the Causes of Autoimmune Diseases For personal use only * Present Approaches Target Symptoms of Autoimmune Diseases Inhibitory receptor agonists: the future of Corticoids, methotrexate, TNF & interleukin autoimmune disease therapeutics? inhibitors (anti-TNF-α,-IL-6, -IL-17, -IL-23 mAbs) Fu
Slide 37: IMP761: First-in-Class LAG-3 Agonist is a Potential Game-Changer
IMP761: First-in-Class LAG-3 Agonist is a Potential Game-Changer For personal use only As the world’s first immunosuppressive agonist antibody to LAG-3 acting upstream on activated T cells, IMP761 targets the root cause of many autoimmune diseases and represents a potential game-changer in the treat
Slide 38: Offer Overview
For personal use only Offer Overview
Slide 39: Offer Overview
Offer Overview Immutep is conducting a fully underwritten1 capital raising of up to approximately A$80 million comprising an institutional placement and a pro rata accelerated non-renounceable entitlement offer (together, the ‘Offer’) For personal use only A fully underwritten capital raising of app
Slide 40: Offer Timetable
Offer Timetable Event AEST Trading halt and announcement of underwritten offer Wednesday, 31 May 2023 For personal use only Placement & Institutional Entitlement Offer Opens Wednesday, 31 May 2023 Announcement of results of Placement and Institutional Entitlement Offer and recommence trading of shar
Slide 41: Use of Funds
Use of Funds The funds raised under the Offer will be used to expand and advance Immutep’s clinical portfolio and strengthen Immutep’s balance sheet For personal use only Uses1 A$m • Post completion of the Offer Immutep will have a pro forma cash balance of Clinical trials 54.8 $135.2m1 Manufacturin
Slide 42: Capital raise will fund expansion of program and extension of funding into Q1 2026
Capital raise will fund expansion of program and extension of funding into Q1 2026* 2023 2024 2025 2026 Budget For personal use only Currently - Funded to Q2 2024 Post Transaction - Funded to Q1 2026 ✓ TACTI-003: Randomized Phase IIb with 154 patients. Topline ❑ TACTI-004: Registrational PIII trial
Slide 43: Thank you!
For personal use only Thank you!
Slide 44: Appendix
For personal use only Appendix
Slide 45: Board and Management
Board and Management For personal use only Dr Russel Howard Pete Meyers Lis Boyce Marc Voigt Prof. Frédéric Triebel, MD, PhD Deanne Miller Non-Executive Chairman Deputy Chairman Non-Executive Director Executive Director & CEO Executive Director, CSO COO, General Counsel Dr Howard has over 45 years’
Slide 46: Summary of Acronyms
Appendix Summary of Acronyms MSD Merck Sharp and Dohme NCCN National Comprehensive Cancer Network For personal use only AIPAC Active Immunotherapy and PAClitaxel NK cell Natural Killer cell APC Antigen presenting cell NSCLC Non-small cell lung cancer CPS Combined positive score NSQ Non-squamous CR C
Slide 47: LAG-3 Therapeutic Landscape Overview
LAG-3 Therapeutic Landscape Overview Company Program Preclinical Phase I Phase II Phase III Total Trials7 Patients8 Agonist Eftilagimod 10 4 1 15 1,741 Alpha(5) For personal use only BMS Relatlimab 10 43 5 58 12,419 Merck & Co. Inc. Favezelimab 1 10 3 14 2,286 Regeneron(1) Fianlimab 1 1 2 4 3,932 H-
Slide 48: Development Strategy in 1st Line NSCLC: Benchmarking to Chemo-containing Regimens
Development Strategy in 1st Line NSCLC (Part A, TACTI-002) Benchmarking to Chemo-containing Treatment Regimens Chemotherapy-containing vs. Chemotherapy-Free IO + IO + doublet chemo Efti + pembrolizumab For personal use only IO + doublet chemo Key takeaways ORR mDoR mOS (TPS >1%) (TPS >0%) (TPS >1%)
Slide 49: Efti Brings A Complementary Approach to IO-IO Combinations
Efti Brings A Complementary Approach to IO-IO Combinations For personal use only Many IO-IO combinations focus on the same Immutep's complementary IO-IO approach focuses on immune cell (e.g. T cell), yet target different targeting different immune cells, e.g. T cells & APC (via efti), immune checkpo
Slide 50: Appendix B – Risk Factors & International Selling Restrictions
For personal use only Appendix B – Risk Factors & International Selling Restrictions
Slide 51: Risk Factors
Risk Factors This Section identifies some of the major risks associated with an investment in the Company. Potential investors should read the risk factors in their entirety in order to appreciate such matters and the manner in which the Company intends to operate before making any decision to inves
Slide 52: Risk Factors
Risk Factors There can be no assurance that the Company will be successful in developing any product candidate, or that the Company will be able to obtain the necessary regulatory approvals with respect to any or all of its product candidates. While a portion of the net proceeds of the Offer will be
Slide 53: Risk Factors
Risk Factors The Company is exposed to significant risks related to its ongoing research and development efforts and might not be in a position to successfully develop any product candidate. Any failure to implement its business strategy could negatively impact the Company's business, financial cond
Slide 54: Risk Factors
Risk Factors The Company's research and development efforts will be jeopardised if it is unable to retain key personnel and cultivate key academic and scientific collaborations. The Company's success depends largely on the continued services of its senior management and key scientific personnel and
Slide 55: Risk Factors
Risk Factors The Company's success depends on its ability to protect its intellectual property and its proprietary technology. The success of the Company is, to a certain degree, also dependent on its ability to obtain and maintain patent protection or, where applicable, to receive/maintain orphan d
Slide 56: Risk Factors
Risk Factors The issuance of a patent is not conclusive as to the inventorship, scope, validity or enforceability, and the Company's patents may be challenged in the courts or patent offices in the U.S., the EU, Australia and elsewhere. Such challenges may result in loss of ownership or in patent cl
Slide 57: International Selling Restrictions
International Selling Restrictions This document does not constitute an offer of New Shares of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the New Shares may not be offered or sold, in any country outside Austr
Slide 58: International Selling Restrictions
International Selling Restrictions Singapore This document and any other materials relating to the New Shares have not been, and will not be, lodged or registered as a prospectus in Singapore with the Monetary Authority of Singapore. Accordingly, this document and any other document or materials in
Slide 59: International Selling Restrictions
International Selling Restrictions United States This document does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States. The New Shares have not been registered under the US Securities Act of 1933 or the securities laws of any state or other jurisdi
Slide 60: Appendix C – Summary of Underwriting Arrangements
For personal use only Appendix C – Summary of Underwriting Arrangements
Slide 61: Summary of Underwriting Arrangements
Summary of Underwriting Arrangements Bell Potter Securities Limited ACN 006 390 772, Jefferies (Australia) Pty Ltd ACN 623 059 898, and Wilsons Corporate Finance Limited ACN 057 547 323 (each an Underwriter, and together the Underwriters) will be acting as joint underwriters, joint lead managers and
Slide 62: Summary of Underwriting Arrangements
Summary of Underwriting Arrangements • there is a material adverse change to the general affairs and business of the Company, or the success, marketing or settlement of the Offer; • a transaction is announced (including without limitation a scheme of arrangement, reconstruction or takeover bid under
Slide 63: Summary of Underwriting Arrangements
Summary of Underwriting Arrangements • any other adverse change or disruption occurs to the political or economic conditions or financial markets of certain countries or any change or development involving a prospective adverse change in national or international political, financial or economic con