Immutep Ltd · ASX:IMM
Immutep — Investor Presentation (June 2021)
61 slides from Immutep's investor presentation, Jun 21, 2021
Slide 1: Capital Raising Presentation
Not for release to US wire services or distribution in the United States or to US Persons For personal use only The global leader in developing LAG-3 therapeutics (ASX: IMM, NASDAQ: IMMP) Capital Raising Presentation
Slide 2: Notice: Forward Looking Statements
Notice: Forward Looking Statements For personal use only The material in this presentation has been prepared by Immutep Limited (ACN 009 237 889) (Immutep or the Company) and includes information about an institutional private placement (Placement) of new fully paid ordinary shares in the Company (S
Slide 3: Notice: Forward Looking Statements
Notice: Forward Looking Statements For personal use only Forward-looking statements involve known and unknown risks, uncertainties and other factors that are outside the Group's control and may cause the Group's actual results, performance or achievements to differ materially from any future results
Slide 4: Overview
Overview For personal use only Immutep is an innovative biotechnology Collaboration deals company developing novel executed with industry leaders immunotherapies for cancer and autoimmune disease Global leadership position in LAG-3 with 4 product candidates in immuno-oncology and autoimmune disease
Slide 5: LAG-3 Overview - The most promising immune checkpoint
For personal use only LAG-3 Overview - The most promising immune checkpoint -
Slide 6: LAG-3 Therapeutic Landscape Overview
LAG-3 Therapeutic Landscape Overview Company Program Preclinical Phase I Phase II Phase III Total Trials Patients Agonist Eftilagimod For personal use only 10 4 14 940 Alpha(5) BMS Relatlimab(6) 7 32 2 41 9,509 Validation Ieramilimab 1 4 “demonstrate a 5 960 benefit for patients”(6) Merck & Co. Inc.
Slide 7: MHC II / LAG-3 Interaction as a Therapeutic Target
MHC II / LAG-3 Interaction as a Therapeutic Target For personal use only 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 LAG
Slide 8: Immutep Mission: Targeting LAG-3 / MHC II
Immutep Mission: Targeting LAG-3 / MHC II Multiple product candidates in numerous diseases For personal use only ✓ 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
Slide 9: Immutep's Immunotherapy Pipeline
Immutep’s Immunotherapy Pipeline* Commercial Program Preclinical Phase I Phase II Late Stage(5) Market Size(6) Rights For personal use only Metastatic Breast Cancer (Chemo – IO) US$29.9 billion AIPAC Non-Small-Cell Lung Carcinoma (IO – IO) (1) US$22.6 billion TACTI-002 Head and Neck Squamous Cell Ca
Slide 10: Immutep Out-Licensed Immunotherapy Pipeline
Immutep Out-Licensed Immunotherapy Pipeline* For personal use only 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 Oncology Global Rights clinica
Slide 11: Capital Raising Overview
For personal use only Capital Raising Overview
Slide 12: Capital Raising Overview
Capital Raising Overview For personal use only Immutep is conducting a capital raising of up to approximately A$65 million via an institutional placement and share purchase plan ▪ Two tranche placement to raise between A$50 million and A$60 million (“Placement”) ▪ A$13.7m or 26.4m new Shares under t
Slide 13: Use of Funds
Use of Funds For personal use only The funds raised under the Placement will be used to expand and advance Immutep’s clinical portfolio and strengthen Immutep’s balance sheet. Uses1 A$m • Post completion of the Placement Immutep Clinical trials 44.0 will have a pro forma cash balance of $113m1 Manuf
Slide 14: Positive data driving expansion of clinical program
Positive data driving expansion of clinical program For personal use only With the ongoing strength of the data being produced by Immutep (e.g. SITC 2020; SABCS 2020; ASCO 2021), Immutep has the opportunity to seek to expand and advance its clinical portfolio through the addition of the following va
Slide 15: Expansion of program and extension of funding to Q4 2023
Expansion of program and extension of funding to Q4 2023 For personal use only 2021 2022 2023 2024 Budget Current Currently - Funded to Q1 CY 2023 Post Transaction - Funded to Q4 20231 ✓ AIPAC (MBC): Final read-out from randomized, ❑ Phase III Registrational Trial: in Metastatic Breast blinded Phase
Slide 16: Offer Timetable
Offer Timetable For personal use only Event AEST Trading halt Thursday, 17 June 2021 Placement announced & Shares resume trading on ASX Monday, 21 June 2021 Placement Tranche 1 settlement of new Shares Friday, 25 June 2021 Placement Tranche 1 issue of new Shares Monday, 28 June 2021 Record Date for
Slide 17: Eftilagimod Alpha (efti or IMP321)
For personal use only Eftilagimod Alpha (efti or IMP321)
Slide 18: Efti: an Innovative LAG-3 I-O Product Candidate
Efti: an Innovative LAG-3 I-O Product Candidate For personal use only • 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” “
Slide 19: Efti: Potential Pipeline in a Product
Efti: Potential Pipeline in a Product Potential for use in various combination settings For personal use only 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 19
Slide 20: Efti + anti-PD-1 Combination: TACTI-002
For personal use only Efti + anti-PD-1 Combination TACTI-002 Update from ASCO 2021
Slide 21: TACTI-002 (Phase II) Design & Status
TACTI-002 (Phase II) Design & Status TACTI-002: Two ACTive Immunotherapeutics in NSCLC and HNSCC For personal use only UNSELECTED FOR PD-L1 In collaboration with PART A: S 1ST LINE MET. NSCLC C R PART B: COMBINED E ORR, PFS, OS, PK, 2ND LINE MET. NSCLC, IMMUNOTHERAPY E PEMBROLIZUMAB + EFTI FOR 12 bi
Slide 22: Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung Cancer (NSCLC) Introduction High unmet medical need for well tolerated and efficacious treatment options For personal use only Epidemiology(1): Unmet need: • 1,876,000 NSCLC diagnoses per annum worldwide • Modest efficacy of anti-PD-1/PD-L1 for pts with < 50% PD-L1 growing by 1.5
Slide 23: TACTI-002 Results: 1st line NSCLC (Part A)
TACTI-002 Results(1) 1st line NSCLC (Part A) • PD-L1 distribution as expected (~70% with < 50% PD-L1 expression) → PD-L1 all comer trial For personal use only • Patients are typical NSCLC 1st line patients Local Read Blinded Read Baseline parameters N (%) Best overall response, iRECIST, N = 36 (inve
Slide 24: TACTI-002 Results: 1st line NSCLC
TACTI-002 Results(1) 1st line Part A* -NSCLC (Part 1st line NSCLC A) 1 & 2 stage Part A* - 1st line NSCLC (stage 1+2) For personal use only 120 Best response: iUPD/iCPD 100 Best response: 100 % change compared to baseline iSD iUPD/iCPD 75 Best % change from baseline 60 iPR iSD 40 50 iPR iCR iCR 20 2
Slide 25: Head & Neck Squamous Cell Carcinoma (HNSCC)
Head & Neck Squamous Cell Carcinoma (HNSCC) Introduction High unmet medical need for well tolerated and efficacious treatment options For personal use only Epidemiology: • More than 800,000 HNSCC diagnoses per annum worldwide(1) • Approximately 500,000 develop metastatic disease & are eligible to re
Slide 26: TACTI-002 Results: 2nd line HNSCC (Part C)
TACTI-002 Results(1) 2nd line HNSCC (Part C) • 2nd line treatment for patients after platinum therapy. PD-L1 all comer population For personal use only • Doubling the ORR compared to historical pembro mono results with 13.5% Complete Responses Baseline parameters (N=39) N (%) Best overall response*,
Slide 27: TACTI-002 Results: 2nd line HNSCC
TACTI-002 Results(1) 2nd line HNSCC (Part C) Part C* - 2nd line HNSCC Stage 1 & 2 Part C* - 2nd line HNSCC Stage 1&2 For personal use only 100 100 Best response: Best response: iUPD/iCPD % change compared to start of therapy 80 iUPD/iCPD 75 iSD Best % change from baseline 60 iSD iPR iPR 50 iCR 40 iC
Slide 28: TACTI-002 Results: 2nd line HNSCC PFS
TACTI-002 Results(1) 2nd line HNSCC (Part C) PFS 2nd line PlotHNSCC For personal use only Kaplan-Meier PFS* 100 Probability of Survival 90 CPS >=1 (n=24) 80 70 unselected for PD-L1 (n=37) 60 50 40 30 20 10 0 0 6 12 18 24 months Overall population (unselected for PD-L1) Selected for PD-L1 expression,
Slide 29: Efti + anti-PD-L1 Combination: INSIGHT-004
For personal use only Efti + anti-PD-L1 Combination INSIGHT-004 Update from ASCO 2021
Slide 30: INSIGHT Platform Trial: INSIGHT-004 Efti + Avelumab
INSIGHT Platform Trial in Solid Tumours INSIGHT-004: Efti + Avelumab Combination For personal use only INSIGHT-004 is a dose escalation study evaluating efti in combination with Bavencio ® (avelumab). Conducted as the 4th arm i.e. Stratum D of the INSIGHT trial. Institut für Klinisch-Onkologische Fo
Slide 31: INSIGHT-004 (Stratum-D) Results
INSIGHT-004 (Stratum-D) Results(1) For personal use only Efficacy Safety • 5/12 (42%) with partial responses in different ▪ Combo of avelumab 800 mg + efti 6 mg or 30 mg efti indications: s.c. is feasible and safe • 1st line MSI high colorectal cancer; 1st line ▪ No unexpected AEs pleural mesothelio
Slide 32: Efti + Chemo Combination: AIPAC
For personal use only Efti + Chemo Combination AIPAC Exciting interim OS results presented at SABCS in December 2020
Slide 33: Goal: Improving OS while maintaining QoL in HR+/HER2– MBC
Goal: Improving OS while maintaining QoL in HR+/HER2– MBC patients For personal use only 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 d
Slide 34: Efti: AIPAC (Phase IIb) design
Efti: AIPAC (Phase IIb) design AIPAC: Active Immunotherapy PAClitaxel in HER2-/ HR+ metastatic breast cancer (MBC) For personal use only Fact sheet Primary endpoint(*) (presented Mar. 2020) included: ✓ Conducted in 7 EU countries • Assessment of Progression-Free Survival (PFS) ✓ Local and blinded in
Slide 35: AIPAC Phase IIb Clinical Results
AIPAC Phase IIb Clinical Results Subgroups: low monocytes and < 65 years – PFS / OS / ORR For predefined sub-groups: For personal use only Clinically meaningful absolute and relative improvement for efficacy parameters, significance for OS ESMO scale of magnitude* = level 4 (makes reimbursement very
Slide 36: AIPAC Phase IIb: Immune Monitoring on Fresh Blood
AIPAC Phase IIb Clinical Results Immune Monitoring on Fresh Blood (up to 70 patients) For personal use only Cytotoxic CD8+ T Cell count over time Stat. significant (p=0.020) (Mean + SEM million cells/L of blood; Correlation: OS and cytotoxic CD8+ p-value Wilcoxon) T cell count CD8 T cell count at 6
Slide 37: AIPAC Summary and Conclusions
AIPAC Phase IIb Clinical Results Summary and Conclusions For personal use only First time Proof of Principle an APC activator has shown meaningful Significant increase in cytotoxic T cell increase in Overall Survival (OS) in a numbers compared to placebo randomised setting Proof of Concept Path Forw
Slide 38: New Trials in Planning: TACTI-003 and INSIGHT-005
For personal use only New Trials in Planning TACTI-003 and INSIGHT-005
Slide 39: TACTI-003 Trial in 1st line HNSCC
TACTI-003 Trial in 1st line HNSCC Current Design + Status For personal use only In collaboration with Design: • Randomised study with ORR as primary endpoint • Sites worldwide (AU, US, Europe) • Approx. 154 pts: either to be randomized to have sufficient pts. in each group or in an experimental arm
Slide 40: INSIGHT-005: Efti + Bintrafusp Alfa Combination
INSIGHT Platform Trial in Solid Tumours Stratum-005: Efti + Bintrafusp Alfa Combination For personal use only To evaluate the feasibility and safety of combined treatment with bintrafusp alfa (M7824) and eftilagimod alpha. Conducted as the 5th arm of the INSIGHT trial. Institut für Klinisch-Onkologi
Slide 41: IMP761 - Autoimmune Diseases
For personal use only IMP761 - Autoimmune Diseases -
Slide 42: Broad potential in targeting auto-reactive memory T cells with IMP761
Broad potential in targeting auto-reactive memory T cells with IMP761 For personal use only 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 fe
Slide 43: Corporate Snapshot & Outlook
For personal use only Corporate Snapshot & Outlook
Slide 44: Corporate Snapshot
Corporate Snapshot For personal use only IMM (ASX) Ticker symbols IMMP (NASDAQ) Securities on issue(1) (as at 16 June 2021) 721.7 million ordinary shares Cash & Cash equivalents (as at 31 March 2021) ~A$51.7 million (US$39.3 million) Market Cap(2) A$443.9 million (US$343.6 million) (as at 16 June 20
Slide 45: 2020 & 2021 News Flow
2020 & 2021 News Flow* For personal use only 2020 2021 ✓ Fast Track designation granted for efti in 1st line ✓ AIPAC – PFS, ORR and OS delivered HNSCC from US FDA ✓ US IND for MBC ❑ Final data from AIPAC: 2nd OS follow up ✓ TACTI-002 – recruitment & data delivered e.g. ✓ Data from TACTI-002 & final
Slide 46: Summary
Summary For personal use only Global leadership position in Multiple active clinical trials LAG-3 with 4 LAG-3 related (including partnered product candidates in candidates), with further immuno-oncology and significant data read-outs autoimmune disease expected in 2021 Compelling clinical data from
Slide 47: Thank You
For personal use only Thank You
Slide 48: International Offer Restrictions & Risk Factors
For personal use only International Offer Restrictions & Risks Factors
Slide 49: International Offer Restrictions
International Offer Restrictions This document does not constitute an offer of Shares of Immutep Limited (Company) in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the For personal use only Shares may not be offered or sold, in
Slide 50: Risk Factors
Risk Factors For personal use only 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
Slide 51: Risk Factors
Risk Factors For personal use only The Company will require additional financing and may be unable to raise sufficient capital, which could have a material impact on its research and development programs or commercialisation of its products or product candidates. The Company has historically devoted
Slide 52: Risk Factors
Risk Factors For personal use only • the Company may experience competition from existing products or new products that may emerge; • the Company and its licensors may be unable to successfully obtain, maintain, defend and enforce intellectual property rights important to protect the Company's produ
Slide 53: Risk Factors
Risk Factors For personal use only 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 rec
Slide 54: Appendix
For personal use only Appendix
Slide 55: Out-Licensed Immunotherapy Pipeline
For personal use only Out-Licensed Immunotherapy Pipeline
Slide 56: Ieramilimab (LAG525) for Cancer
Ieramilimab (LAG525) for Cancer For personal use only • 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 2
Slide 57: GSK'781 (IMP731) for Autoimmune Diseases
GSK’781 (IMP731) for Autoimmune Diseases For personal use only • GSK holds an exclusive WW licence 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 i
Slide 58: Other Partnerships
For personal use only Other Partnerships
Slide 59: Collaboration with Cardiff University
Collaboration with Cardiff University For personal use only Developing a small molecule anti-LAG-3 therapy • New Research Collaboration Agreement with Cardiff University signed 1 July 2019 Project Aims: • Deepens existing collaboration, entered into via an MTA 1. Efficacy of a LAG-3 blocking antibod
Slide 60: Collaboration with LabCorp
Collaboration with LabCorp For personal use only • Licence and Collaboration Agreement for immuno- Laboratory Corporation of America oncology products or services (entered in Oct 2020) Holdings (LabCorp) is a leading global life sciences company focused on • Development of lab tests that may help on
Slide 61: Other Efti Partnerships
Other Efti Partnerships For personal use only • EOC, an Eddingpharm spin-off holding the Chinese rights for efti, Phase I study in MBC ongoing with a Phase II trial in preparation • Milestone and royalty bearing partnership • Spin off from NEC, Japan: aims to develop cancer drugs discovered by artif