Immutep AGM 2021 - CEOs Presentation
The global leader in developing LAG - 3 therapeutics 2021 AGM Presentation Marc Voigt, CEO 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 was authorised for release by the CEO, Marc Voigt . Notice: Forward - Looking Statements Global leadership position in LAG - 3 with 4 LAG - 3 related product candidates in immuno - oncology and autoimmune disease Exciting potential of lead product candidate efti as a combination therapy following c ompelling clinical data & strong rationale to combine with multiple FDA approved treatments Strengthened partnerships & collaborations with large pharma industry leaders General Overview FY21 saw Immutep transform into a late - stage biotech with more trials, partners and industry momentum than ever LAG - 3 Pioneer: French immunologist Prof Frédéric Triebel, Immutep CMO & CSO Existing approved immuno - oncology therapies target: LAG - 3 is a validated immune checkpoint PD - 1 & PD - L1 e.g. CTLA - 4 e.g. LAG - 3 was validated by BMS in a Phase III trial (ASCO 2021) Immutep is positioned to lead in LAG - 3 with more LAG - 3 related programs than any other pharma or biotech 6 LAG - 3 Therapeutic Landscape Overview Company Program Preclinical Phase I Phase II Phase III Total Trials Patients Eftilagimod Alpha (5) 14 967 BMS Relatlimab (6) 41 9,775 Merck & Co. Inc. Favezelimab 6 1066 Ieramilimab 5 952 Macrogenics Tebotelimab 6 1422 H - L Roche RO7247669 3 538 B.I. BI754111 5 649 Regeneron (1) Fianlimab 2 836 Innovent IBI110 2 328 Tesaro (3) TSR - 033 2 139 Incyte INCAGN02385 2 74 Symphogen (2) SYM022 3 169 F - star FS - 118 2 102 Xencor XmAb - 22841 1 242 IMP761 -- -- GSK2831781 (IMP731) 3 207 Antagonist Agonist Agonist Depleting AB Autoimmune Oncology 10 4 1 4 2 1 7 32 2 3 4 1 3 3 2 1 5 (4) 1 1 1 1 2 1 1 Sources: GlobalData, Company websites, clinicaltrials.gov, and sec.gov, as of 25th October 2021. The green bars above represent programs conducted by Immutep &/or its partners. Total trials includes all active, completed &/or inactive trials. Patient totals are based on estimated total enrolled &/or to be e nro lled. Not a complete list of currently existing LAG - 3 products. 1) As of January 7, 2019 Regeneron is in full control of program and continuing development ( https://www.sec.gov/Archives/edgar/data/872589/000110465919000977/a19 - 1325_18k.htm ) 2) On 3 Apr. 2020 Les Laboratoires Servier acquired Symphogen 3) Tesaro was acquired by and is now part of GSK (www.gsk.com/en - gb/media/press - releases/gsk - completes - acquisition - of - tesaro - an - oncology - focused - biopharmaceutical - company/ ) 4) Includes two completed Phase I studies and one discontinued Phase 2 study 5) Including IITs, one planned trials (MBC trial by EOC) 6) RELATIVITY - 047 (https://investors.bms.com/iframes/press - releases/press - release - details/2021/Bristol - Myers - Squibb - Announces - RELATIVITY - 047 - a - Trial - Evaluating - Anti - LAG - 3 - Antibody - Relatlimab - and - Opdivo - nivolumab - in - Patients - with - Previously - Untreated - Metastatic - or - U nresectable - Melanoma - Meets - Primary - Endpoint - of - Progression - Free - Survival/default.aspx) 1 1 PDUFA: 19 March 2022 & submitted to EMA 1 1 Exposure to two very large and growing pharmaceutical markets US$222.38 billion by 2027 growing at 7.4% CAGR Autoimmune 1 Oncology 2 1 https://www.reportlinker.com/p06050561/Global - Autoimmune - Disease - Therapeutics - Industry.html 2 https://www.alliedmarketresearch.com/oncology - cancer - drugs - market US$139.40 billion by 2027 growing at 2.8% CAGR Efti: Potential Pipeline in a Product Potential for use in various combination settings Excellent safety profile Unique MHC II agonist Encouraging efficacy data Low cost of goods Unique protective IP positioning (unlike ICI mAbs) Chemo - IO combo IO - IO combo Immutep Pipeline Update TACTI - 002 phase II trial in head and neck cancer (Part C) AIPAC phase IIb trial in breast cancer TACTI - 002 phase II trial in lung cancer (Part A) Clinical data building efti’s intrinsic value in FY21 • Final Overall Survival (OS) data supports Phase III clinical development • OS benefit trend in total population, with median survival benefit of +2.9 months from efti plus chemotherapy, compared to chemotherapy plus placebo • Statistically significant and clinically meaningful OS benefit pre - specified patient subgroups of: • +7.5 months in patients under 65 years • +19.6 months in patients with low monocytes • +4.2 months in patients with luminal B • Very favourable overall response rate (ORR) of 41.7% with favourable duration and depth of responses in 1st line NSCLC • 2 patients with Complete Responses (complete disappearance of all lesions) • Tumor responses seen in all PD - L1 subgroups, including patients typically less responsive to anti - PD - 1 therapy • Encouraging ORR of 29.7% in 2nd line HNSCC patients • Very favourable duration and depth of responses, with 5 Complete Responses and a minimum duration of response extended to > 9 months across all responding patients • Responses continue to be seen across all PD - L1 subgroups INSIGHT - 004 trial in solid cancers • 41.7% of patients showed a Partial Response • Encouraging anti - tumour activity signals in difficult to treat cancers Expanded Trial Pipeline Registrational Phase III Trial Planning commenced for a new Phase III trial evaluating efti in metastatic breast cancer. Positive EMA scientific advice received post FY21. TACTI - 003 Phase IIb New study evaluating efti in the commercially more relevant 1 st line recurrent or metastatic HNSCC in a randomized setting INSIGHT - 003 (Stratum C) First triple combination therapy study of efti in various solid tumours INSIGHT - 005 (Stratum E) New study of efti in combination with bintrafusp alfa in patients with various solid tumours in collaboration with* *subject to further review by Immutep based on bintrafusp alfa performance 12 Immutep’s LAG - 3 Trial Pipeline* Program Preclinical Phase I Phase II Late Stage ( 5) Commercial Rights Market Size (6) Eftilagimod Alpha (efti or IMP321) APC activating soluble LAG - 3 protein US$29.9 billion US$1.9 billion US$22.6 billion US$2.3 billion Efti Oncology Non - Small - Cell Lung Carcinoma (IO – IO) (1) TACTI - 002 Head and Neck Squamous Cell Carcinoma (IO – IO) (1) TACTI - 002 Solid Tumors (IO – IO) (2), (3a) INSIGHT - 004 Solid Tumors (IO – IO – chemo) (2) INSIGHT - 003 Metastatic Breast Cancer (Chemo – IO) AIPAC Global Rights Notes * Information in pipeline chart current as at Novemberr 2021 Metastatic Breast Cancer (Chemo – IO) (4b) Chinese Rights IMP761 (Agonist AB) US$149.4 billion (2025) Autoimm. Global Rights (1) In combination with KEYTRUDA® (pembrolizumab) (1b) Planned new trial for 1 st line HNSCC patients (2) INSIGHT Investigator Initiated Trial (“IIT”) is controlled by lead investigator and therefore Immutep has no control over thi s clinical trial (3) a ) In combination with BAVENCIO® (avelumab); b) in combination with Bintrafusp alfa (4) a) Conducted by CYTLIMIC in Japan; b) Conducted by EOC in China. Immutep has no control over either of these trials. (5) Late stage refers to Phase IIb clinical trials or more clinically advanced clinical trials (6) GlobalData Market Size forecast for US, JP, EU5, Urban China and Australia; KBV Research : https://www.kbvresearch.com/autoimmune - disease - therapeutics - market/ ) (7) IIT conducted by University Hospital Pilsen. Immutep has no control over this trial. (8) Ex China § § Solid Tumors (Cancer Vaccine) (4a) YNP01 / YCP02 / CRESCENT 1 Inf. Dis. COVID - 19 disease (Monotherapy) (7) EAT - COVID Global Rights (8) § Head and Neck Squamous Cell Carcinoma (IO – IO) (1b) TACTI - 003 § Solid Tumors (IO – IO) (2), (3b) INSIGHT - 005 13 Immutep Out - Licensed Immunotherapy Pipeline* Program Preclinical Phase I Phase II Late Stage (1) Commercial Rights/Partners Updates LAG525 (Antagonist AB) Novartis currently has five clinical trials for LAG525 in multiple cancer indications for approx. 1,000 patients. (4) GSK‘781 (Depleting AB) Two successful Phase I studies. Phase II clinical study in up to 242 ulcerative colitis patients was discontinued. (5) Solid Tumors + Blood Cancer ( IO - IO Combo) Oncology Autoimmune Triple Negative B reast C ancer (Chemo - IO Combo) M elanoma ( IO - IO - Small Molecule Combo) S olid T umors (IO - IO Combo) Triple Negative B reast C ancer (Chemo - IO - Small Molecule Combo) Ulcerative Colitis Psoriasis (3) Global Rights Global Rights Notes * Information in pipeline chart current as at Nov ember 2021 (1) Late stage refers to Phase IIb clinical trials or more clinically advanced clinical trials (2) Reflects completed Phase I study in healthy volunteers (3) Reflects completed Phase I study in healthy volunteers and in patients with plaque psoriasis (4) https://clinicaltrials.gov/ct2/results?cond=&term=LAG525&cntry=&state=&city=&dist= (5) https://clinicaltrials.gov/ct2/results?cond=&term=GSK2831781&cntry=&state=&city=&dist= and https://www.gsk.com/media/5957/q1 - 2020 - results - slides.pdf (6) Discontinued in Jan 2021 Healthy Japanese and Caucasian Subjects (2) § § Ulcerative Colitis (6) Treating general inflammation : corticoids, methotrexate, anti - TNF - a, - IL - 6, - IL - 17, - IL - 23 mAbs Treating the disease process : silencing the few autoimmune memory T cells accumulating at the disease site with IMP761 THE PRESENT: FIGHTING THE SYMPTOMS THE FUTURE: FIGHTING THE CAUSE Broad potential in targeting auto - reactive memory T cells with IMP761 POTENTIAL GAME CHANGER IN AUTOIMMUNE DISEASES (US$139.40 billion by 2027 ) 1 1 https://www.reportlinker.com/p06050561/Global - Autoimmune - Disease - Therapeutics - Industry.html Other Highlights of FY 21 TACTI - 002 Part A expansion - 1st line non - small cell lung cancer (NSCLC) TACTI - 002 whole trial recruitment advanced Efti GMP manufacturing scale up progress to increase manufacturing to 2,000L capacity bioreactors IMP761 c ell line development completed and preparations for GMP manufacturing commenced Intellectual property position strengthened with 9 new patents in FY21 for efti, IMP761 and IMP701 ( leramilimab) Final AIPAC and interim TACTI - 002 data presented at SITC 2021 Two further Chinese patents granted TACTI - 002 1 st line and 2 nd line NSCLC fully recruited French R&D tax incentive received (A$3.4m) Post FY21 Partner & Collaborator Progress IMP701 (LAG525) 5 clinical trials in multiple cancer indications - more than 1,000 patients. Data presented at ESMO Congress in 2021. IMP731 (GSK2831781) Ulcerative colitis trial stopped; further assessment ongoing to determine next steps. Partnership remains in place. Efti as vaccine adjuvant Studies of peptide vaccine, CYT001 in advanced or metastatic solid cancer. Efti New study of efti in combination with chemotherapy in metastatic breast cancer patients in China. Diagnostic Collaboration with LabCorp (NYSE: LH) to support the development of immuno - oncology products or services. Licensing revenue decreased in FY21 mainly due to a GSK milestone payment of A$7.49M in FY20. No such milestones were recognised in FY21 Research material sales increased from A$280K for FY20 to A$313K for FY21 A$3.4m R&D tax rebate from Australian and French government were recognised in FY21 R&D and IP expenses decreased a s expected due to the decreased clinical trial activity for AIPAC & TACTI - mel Strengthened cash balance with A$29.6 million placement in November 2020 and A$67.2 million two - tranche placement and share purchase plan (tranche two completed in July 2021) Loss after tax for FY21 was higher compared to FY20 mainly due to the decrease in licencing income 17 Key Financials Revenue and other income A$ 4.0M A$ 16.5M G&A Expenses A$6.3M A$ 6.3M R&D and IP expenses A$17.2M A$22.5 M Net loss A$29.9M A$13.5M Net operating cash outflow A$17.6M A$ 10.8M Cash and cash equivalents at the end of the financial year A$60.6M A$26.3M Cash and cash equivalents at 30 September 2021 A$106.4M FY21 FY20 Outlook 19 2022 News Flow* Notes: *The actual timing of future data readouts may differ from expected timing shown above. These dates are provided on a calenda r y ear basis. H2 2022 H1 2022 • TACTI - 003 s tart & ongoing recruitment of new randomised trial in 1st line HNSCC in 2021/2022 • Further data from TACTI - 002 • Planning for AIPAC - 003 trial in MBC • Further intellectual property protection via new patents • Further updates from partnered programs (e.g. EOC Pharma, GSK, Novartis, EAT COVID, CYTLIMIC) • Manufacturing scale up to 2,000L • Ongoing regulatory engagement, including US FDA • Further data from TACTI - 002 • Further updates from TACTI - 003 • INSIGHT - 003 first interim results in 2022 • Updates from IMP761 • Further updates from partnered programs 20 Summary Global leadership position in LAG - 3 with 4 LAG - 3 product candidates in immuno - oncology and autoimmune disease, all with different mechanisms of action Multiple active clinical trials (including partnered candidates), with further significant data read - outs expected in 2022 Established collaborations with e.g. Merck (MSD), Pfizer, Merck KGaA , Novartis and GSK Compelling clinical data from efti & strong rationale to combine with multiple FDA approved treatments Corporate Snapshot (1) Currently ~30.28% of the ordinary shares are represented by ADSs listed on NASDAQ where 1 ADS represents 10 ordinary shares. Pl ease refer to latest Appendix 2A released on ASX for a detailed summary of all securities on issue. (2) Market capitalisation based on ASX share price of A$0.51 on 23 November 2021. USD equivalent of cash balance was calculated with FX rate of 0.7206 and USD equivalent of market cap was calculated wit h FX rate of 0.7221. Ticker symbols IMM (ASX) IMMP (NASDAQ) Securities on issue (1) as at 23 November 2021 ~ 853.9 million ordinary shares Cash balance as at 30 September 2021 ~ A$106.4 million (US$76.7 million) Market Cap (2) as at 23 November 2021 ~ A$435.5 million (US$314.5 million) Thank you
More from Immutep Limited
Join Listcorp to create a personalised news feed, follow your favourite companies, save useful news, and more.