Immutep Ltd · ASX:IMM
Immutep — Investor Presentation (June 2024)
66 slides from Immutep's investor presentation, Jun 3, 2024
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 Unlocking the power of the immune system to fight cancer and autoimmune disease I Capital Raising Investor Presentation – June 2024 (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 Capital Raising
Immutep Capital Raising Investor Presentation Phase III in First Line NSCLC in Collaboration with MSD
Slide 7: Immutep Investment Highlights
Immutep Investment Highlights Leader in LAG-3 First-in-Class Validation through Global presence; strong Large opportunity & immunotherapy Lead Candidate partnerships IP/balance sheet multiple catalysts ahead LAG-3 pure play with three Eftilagimod alpha (efti), a Multiple partnerships Global presence
Slide 8: Executive Summary
Executive Summary Pivotal Phase III in first line NSCLC in collaboration with MSD and $100m underwritten capital raise Pivotal Phase III in • Immutep and MSD (Merck & Co., Inc., Rahway, NJ, USA) enter a collaboration for Immutep’s TACTI-004 pivotal Phase III trial in first line non-small cell lung c
Slide 9: Pivotal Phase III in Collaboration with MSD
Pivotal Phase III in Collaboration with MSD Significant commitment from MSD – robust trial design IMM Collaboration with MSD Immutep has entered into a significant clinical trial collaboration and supply agreement (CTCSA) with MSD to evaluate efti in combination with KEYTRUDA and chemotherapy for tr
Slide 10: Immutep & MSD to Undertake Phase III Trial in NSCLC
Immutep & MSD to Undertake Phase III Trial in NSCLC Opportunity to set a new standard of care across entire NSCLC population regardless of PD-L1 expression MSD Collaboration & Phase III Design • TACTI-004 will be a 1:1 randomised, double-blind, multinational, controlled clinical study to evaluate Im
Slide 11: KEYTRUDA, the World's Top Selling Drug with >US$25 Bn in Sales
KEYTRUDA, the World’s Top Selling Drug with >US$25 Bn in Sales Non-Small Cell Lung Cancer represents KEYTRUDA’s largest indication Substantial commercial opportunity for efti with • KEYTRUDA contributed ~42% of MSD’s overall revenue in 2023; patent expiry in 2028 Immune Checkpoint Inhibitors (ICIs)
Slide 12: Well Positioned for Partnering with Large Pharma Companies
Well Positioned for Partnering with Large Pharma Companies Significant Commercial Potential with ICIs in, and beyond, 1L NSCLC Global Checkpoint Inhibitor Sales (in US$ Million) KEYTRUDA Sales in the US (in US$ Billions) NSCLC HNSCC Melanoma Other • Efti’s favorable safety profile and encouraging cl
Slide 13: Positive Phase II Data in Efti/KEYTRUDA Combo in 1L NSCLC
Positive Phase II Data in Efti/KEYTRUDA® Combo in 1L NSCLC Underpins Confidence for TACTI-004 Phase III trial More than double Overall Survival More than double Progression Free Survival Double the Overall Response Rate of KEYTRUDA® (anti-PD-1) monotherapy and well above of KEYTRUDA® monotherapy in
Slide 14: Chemotherapy is Additive to KEYTRUDA's Efficacy in 1L NSCLC
Chemotherapy is Additive to KEYTRUDA’s Efficacy in 1L NSCLC Results from INSIGHT-003 support same additive benefit from chemo to Efti + KEYTRUDA in 1L NSCLC ORR mPFS mOS ORR ORR (TPS >1%) (TPS >1%) (TPS >1%) (TPS 0-100%) (TPS <50%) 71.4 • Without chemo… 70.6 25 Efti + pembro has 23.3 higher ORR, PFS
Slide 15: Targeting Entire 1L NSCLC Population Regardless of PD-L1 Status
Targeting Entire 1L NSCLC Population Regardless of PD-L1 Status Strength of clinical data in high, and particularly negative & low PD-L1 expressing patients, positions efti in combination with KEYTRUDA & chemotherapy to potentially establish a new standard of care in NSCLC, one of the largest indica
Slide 16: Late-Stage Pipeline with Positive Clinical Data & Near-Term Catalysts
Late-Stage Pipeline with Positive Clinical Data & N-Term Catalysts Efti’s three late-stage oncology programs are focused on: Lung, Head and Neck, and Breast Cancer Non-Small Cell Lung Cancer (NSCLC) Head & Neck Squamous Cell Carcinoma (HNSCC) Breast Cancer Epidemiology ~2.5 million new lung cancer d
Slide 17: Clinical Trials Target Large Addressable Markets
Clinical Trials Target Large Addressable Markets *Efti has FDA Fast Track designation in 1L NSCLC and 1L HNSCC 17 Market size estimates are based on intelligence data from GlobalData (estimations 2024 for 8MM: FR, DE, IT, JP, ES, UK, US, China), and Nature Reviews Drug Discovery 22, 264-265 (23 Jan
Slide 18: Capital Raise will Fund Expansion of Program and Extension of Funding to end of CY2026
Capital Raise will Fund Expansion of Program and Extension of Funding to end of CY2026 with Key Catalysts Ahead Post raise Immutep will have a pro forma cash balance of $A195m providing funding to end of CY2026. Recent Milestones Post Transaction - Funded to end of CY2026 ✔ TACTI-004: Trial collabor
Slide 19: Efti
Efti A proprietary soluble LAG-3 protein and first-in-class MHC Class II agonist
Slide 20: Pioneering LAG-3 Immunotherapy Portfolio
Pioneering LAG-3 Immunotherapy Portfolio Immutep has multiple first-in-class therapeutics designed LAG-3 around the interaction of MHC Class II molecules on Antigen-presenting T Cell cells (APC) antigen-presenting cells (APC) and LAG-3 on T-cells to fight cancer & autoimmune disease MHC Class II Tar
Slide 21: Deep LAG-3 Pipeline in Oncology & Autoimmune Diseases
Deep LAG-3 Pipeline in Oncology & Autoimmune Diseases Program Indication Preclinical Phase I Phase II Late Stage# Collaborations Commercial Rights 1L Non-Small Cell Lung Cancer (NSCLC) TACTI-004 | Efti + Pembrolizumab + Chemo a 1L Head & Neck Squamous Cell Carcinoma (HNSCC) TACTI-003 | Efti + Pembro
Slide 22: IMM Lead Indication: Efti + Keytruda in First Line NSCLC
IMM Lead Indication Efti + Keytruda in First Line Non-Small Cell Lung Cancer (NSCLC)
Slide 23: NSCLC Overview
NSCLC Overview • Lung cancer is a leading cause of cancer death1,2 • 80 - 85% of lung cancers are non-small cell lung cancer (NSCLC) • There are ~2.0 million NSCLC diagnoses worldwide annually • Only ~20% of patients respond to immune checkpoint inhibitor (ICI) monotherapy • Despite treatment advanc
Slide 24: Evolution of Efti + KEYTRUDA in Clinical Trials
Evolution of Efti + KEYTRUDA® in Clinical Trials Growing collaborative effort with MSD over time with positive clinical outcomes across multiple cancers TACTI-mel TACTI-002 TACTI-002 Expansion TACTI-003 TACTI-004 Phase I Phase II Phase II Phase IIb Phase III • First in human study of efti in • First
Slide 25: TACTI-002 / KN-798 Trial Overview and Baseline Characteristics
TACTI-002 / KN-798 Trial Overview and Baseline Characteristics Part A: Large Phase II trial (N=114) in metastatic first Line non-small cell lung cancer (1L NSCLC) TACTI-002 (Part A) in 1L NSCLC • Phase II, open label, Simon’s two stage design • 114 patients enrolled across six countries (US, UK, ES,
Slide 26: Strong Efficacy Data across all PD-L1 Expression Levels in 1L NSCLC
Strong Efficacy Data across all PD-L1 Expression Levels in 1L NSCLC Tumor Response by PD-L1 Expression Level1 All-Comer Negative PD-L1 Low PD-L1 High PD-L1 Any PD-L1 • Strong efficacy across all patients, including negative & low expressors (~75% of patients in TACTI-002), TPS 0-100% TPS <1% TPS 1-4
Slide 27: Favorable Safety Coupled with Differentiated OS
Favorable Safety Coupled with Differentiated OS Differentiated OS from Efti + Pembrolizumab achieved with a favorable safety profile given complementary IO approaches targeting two different immune cells as well as no use of chemotherapy Drug-related Adverse Therapy in 1L NSCLC TPS >1% Events Leadin
Slide 28: Registration Strategy in First line NSCLC
Registration Strategy in First line Non-Small Cell Lung Cancer (1L NSCLC)
Slide 29: Treatment Landscape in 1L NSCLC (US/EU)
Treatment Landscape in 1L NSCLC (US/EU) KEYTRUDA (pembrolizumab) and chemotherapy utilized across entire 1L NSCLC landscape, regardless of PD-L1 expression, which is the same patient population the efti + pembrolizumab + chemotherapy combination will be evaluated in (1) Simplified based on ESMO and
Slide 30: Pivotal Phase III in 1L NSCLC
Pivotal Phase III in 1L NSCLC TACTI-004, a double-blinded, randomized Phase III trial in patients with advanced/metastatic non-small cell lung cancer (NSCLC) receiving eftilagimod alpha (MHC class II agonist) in combination with pembrolizumab (PD-1 antagonist) and chemotherapy. TACTI-004 Trial Desig
Slide 31: TACTI-004 General Study Design and Background
TACTI-004 General Study Design and Background Developed based on: Collaboration: • Outstanding clinical data with efti + Keytruda in all PD-L1 • Study design was developed in collaboration with MSD strata with or without chemotherapy in TACTI-002 and • MSD has entered into very limited number of Pha
Slide 32: Timeline, Objectives and Statistical Overview
Timeline, Objectives and Statistical Overview Objectives & Statistical Overview • Study powered for Overall Survival as primary objective and/or with PFS as dual endpoint • Sample size: ~750 patients expected • Enrollment Duration: Expected to be ~18 months based on initial feasibility • Futility An
Slide 33: Efti + Anti-PD-1 in Head & Neck Cancer
Efti + Anti-PD-1 in Head & Neck Cancer
Slide 34: TACTI-003 - Randomised Phase IIb in First Line HNSCC
TACTI-003 - Randomised Phase IIb in First Line HNSCC Efti + anti-PD-1 therapy has FDA Fast Track designation in first line recurrent or metastatic HNSCC TACTI-003/KEYNOTE-PNC-34: First Line Recurrent or Metastatic Head & Neck Squamous Cell Carcinoma (1L HNSCC) TACTI-003 Trial Design • Randomised, mu
Slide 35: Positive Preliminary Topline Results in PD-L1 Negative Patients
Positive Preliminary Topline Results in PD-L1 Negative Patients TACTI-003/KEYNOTE-PNC-34 (Cohort B): First Line Recurrent or Metastatic Head & Neck Squamous Cell Carcinoma with Negative PD-L1 Expression (CPS <1) TACTI-003, Cohort B (CPS <1) Overall Response Rate Disease Control Rate ✔ Primary endpoi
Slide 36: Efti + Chemotherapy in Metastatic Breast Cancer
Efti + Chemotherapy in Metastatic Breast Cancer
Slide 37: AIPAC-001 - Efti + Chemo in Randomized Phase IIb in MBC
AIPAC-001 - Efti + Chemo in Randomized Phase IIb in MBC AIPAC was conducted in 34 sites AIPAC-001 across: Belgium, France, Hungary, Study Design Poland, Netherlands, United Kingdom, and Germany Initial OS Data Late Breaking Abstract Final Results from AIPAC Paclitaxel Efti + paclitaxel CD8+ T cell c
Slide 38: AIPAC-003 Phase II/III Trial Underway in Metastatic Breast Cancer
AIPAC-003 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) • Trial design incorporates feedback from FDA & EMA and provides risk-balanced approach • Pa
Slide 39: Encouraging Safety and Early Efficacy in AIPAC-003
Encouraging Safety and Early Efficacy in AIPAC-003 50% Response Rate, 100% DCR, and a Confirmed Complete Response at Higher 90 mg Efti Dosing AIPAC-003: Active Immunotherapy (Eftilagimod Alpha) and PAClitaxel Case Study of 35-year-old Woman with Confirmed CR that Continues with Efti Monotherapy • Ef
Slide 40: Additional Studies & Manufacturing
Additional Studies & Manufacturing
Slide 41: Efti + Anti-PD-L1 (Avelumab) in Metastatic Urothelial Cancer
Efti + Anti-PD-L1 (Avelumab) in Metastatic Urothelial Cancer INSIGHT-004 – Promising efficacy signals in Phase I dose INSIGHT-005 – Ongoing Phase I study in metastatic escalation study in advanced solid tumors* urothelial cancer • Efti in combination with avelumab (BAVENCIO®) safe • Investigator-ini
Slide 42: 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 Phase II Trial Design* Screening Study trea tment Fol low up • First trial studying efti in neoadjuvant, non-metastatic cancer settin
Slide 43: Novel Small Molecule Anti-LAG-3 Preclinical Program
Novel Small Molecule Anti-LAG-3 Preclinical Program • Commercial opportunity for a “blocking” anti-LAG-3 small molecule is potentially significant. • To date, over a dozen companies have initiated clinical trials investigating antagonist anti-LAG-3 antibodies including Bristol “We are delighted to c
Slide 44: IMP761: First-in-Class LAG-3 Agonist is a Potential Game-Changer
IMP761: First-in-Class LAG-3 Agonist is a Potential Game-Changer IMP761 is the world’s first immunosuppressive LAG-3 agonist antibody that is designed to address the underlying cause of many autoimmune diseases. This potential game-changer in the treatment landscape is expected to enter the clinic b
Slide 45: Clinical Development of IMP761
Clinical Development of IMP761 Leading World-Call Research Institute Appointed to Conduct First-in-Human Study Key aspects: • Placebo-controlled, double-blind Phase I (N = 49) • Centre for Human Drug Research (CHDR) has been selected for conduct • World-class institute in Leiden, the Netherlands spe
Slide 46: Commercial Scale Manufacturing of Efti
Commercial Scale Manufacturing of Efti Eftilagimod alpha (efti) Key Highlights A first-in-class soluble LAG-3 fusion protein with high affinity for a subset of MHC Class II • Efti is a fusion protein of soluble LAG-3 and Fc part of human IgG1, not an antibody molecules on antigen-presenting cells (A
Slide 47: Corporate Snapshot & Offer Overview
Corporate Snapshot & Offer Overview
Slide 48: Corporate Snapshot
Corporate Snapshot Tickers Shares on issue1,2,5 Board IMM (ASX) 1,189m IMMP (NASDAQ) Russell Howard (Ph.D.) Marc Voigt Lis Boyce Non-Executive Chairman Executive Director & CEO Non-Executive Director Market capitalisation 3 Cash at Bank4 A$535m A$95.4m ~US$62.2m Pete Meyers Frédéric Triebel (M.D., P
Slide 49: Offer Overview
Offer Overview Immutep is conducting the Offer, which is a fully underwritten 1 capital raising of up to approximately A$100 million comprising an institutional placement and a pro rata accelerated non-renounceable entitlement offer A fully underwritten Offer of approximately A$100.2 million which c
Slide 50: Use of Funds
Use of Funds The funds raised under the Offer will be used to expand and advance Immutep’s clinical portfolio, develop commercial scale Efti manufacturing and strengthen Immutep’s balance sheet Use of funds A$ Million • Post completion of the Offer, Clinical trials Immutep will have a pro forma cash
Slide 51: Offer Timetable
Offer Timetable Event AEST* Trading halt and announcement of underwritten offer Monday, 3 June 2024 Placement & Institutional Entitlement Offer Opens Monday, 3 June 2024 Announcement of results of Placement and Institutional Entitlement Offer and recommence trading of shares on ASX Wednesday, 5 June
Slide 52: Risk Factors & International Selling Restrictions
Risk Factors & International Selling Restrictions
Slide 53: 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 54: 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 55: 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 56: 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 57: 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 58: 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 59: 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 60: 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 61: International Selling Restrictions
International Selling Restrictions New Zealand This document has not been registered, filed with or approved by any New Zealand regulatory authority under the Financial Markets Conduct Act 2013 (FMC Act). The New Shares are not being offered to the public within New Zealand other than to existing sh
Slide 62: Summary of Underwriting Arrangements
Summary of Underwriting Arrangements
Slide 63: Summary of Underwriting Arrangements
Summary of Underwriting Arrangements Bell Potter Securities Limited ACN 006 390 772 (Underwriter) will be the sole underwriter of the Offer and the Underwriter, Canaccord Genuity (Australia) Limited ACN 075 071 466 and Wilsons Corporate Finance Limited ACN 057 547 323 (each a JLM, and together the J
Slide 64: Summary of Underwriting Arrangements
Summary of Underwriting Arrangements • any regulatory body conducts any new material inquiry or public action against a member of the Group or makes, or communicates any intention to make, any materially adverse finding, ruling, order or determination against any member of the Group; • there is a ma
Slide 65: Summary of Underwriting Arrangements
Summary of Underwriting Arrangements • a representation or warranty made or given by the Company under the Underwriting Agreement proves to be, or has been, or becomes, untrue or incorrect; • any other adverse change or disruption occurs to the political or economic conditions or financial markets o
Slide 66: Thank You
: =) Immutep Thank You