Telix Pharmaceuticals Limited · ASX:TLX
Telix Pharmaceuticals — Jefferies Healthcare Conference 2019
28 slides from Telix Pharmaceuticals's conference presentation, Jun 4, 2019
Slide 1: Jefferies Healthcare Conference
For personal use only ASX:TLX Jefferies Healthcare Conference New York 4th June 2019
Slide 2: Notices
Notices For personal use only The information contained in the presentation is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Telix Pharmaceuticals Limited (“Telix”) in any jurisdiction, including the United States. No representation or warranty,
Slide 3: Company Snapshot
Melbourne Company Snapshot For personal use only • Founded in 2015 by Dr. Chris Behrenbruch and Dr. Andreas Kluge, experienced nuclear medicine executives • Board : Kevin McCann (ex-Chairman, Macquarie Bank), Mark Nelson (Caledonia), Jann Skinner (ex-PwC Partner) and Oliver Buck (ITM Group) Kyoto •
Slide 4: Financial Snapshot
Financial Snapshot $1.06 (31 May 2019) For personal use only (YTD) Mkt. Cap: ~A$230m (USD $160m) Disease Focus Oncology Clinical Stage Phase I - III Shares on Issue 218.4m Options on Issue 11.1m IPO Price: $0.65 Cash on Hand ~AUD $25m ASX Ticker TLX • Nov 2017 – $50m IPO on the Australian Securities
Slide 5: Our Approach: Molecularly-Targeted Radiation (MTR)
Our Approach : Molecularly-Targeted Radiation (MTR) For personal use only MTR works by chemically “linking” radioactive isotopes to targeting molecules that are very specific for cancer cells. At low doses, this enables the location of the cancer cells to be pinpointed using PET imaging. At high dos
Slide 6: Positron Emission Tomography – PET
Positron Emission Tomography – “PET” See it, Treat it… For personal use only • Telix develops drugs that deliver targeted radiation directly to cancer. At low radiation dose (or using diagnostic nuclides), the patient can be imaged The use of molecular imaging with PET enables a precision medicine a
Slide 7: Why is MTR so therapeutically effective?
Why is MTR so therapeutically effective? For personal use only CONVENTIONAL TARGETED MOLECULARLY TARGETED RADIATION Non-Radioactive Drugs MTR Therapy 7
Slide 8: Clinical Pipeline
Clinical Pipeline Commercial For personal use only Isotope Target Agent Phase I Phase II Phase III 177Lu CA-IX Antibody TLX250 (Girentuximab) Therapy Renal 89Zr CA-IX Antibody TLX250-Cdx (Girentuximab) Imaging Prostate 177Lu PSMA Antibody TLX591 TLX591 Therapy 68Ga Small Imaging PSMA TLX591-Cdx (PSM
Slide 9: Telix's Pipeline is a Multi-$Bn Opportunity
Telix’s Pipeline is a Multi-$Bn Opportunity * For personal use only TLX101: The treatment of GBM is TLX591: Metastatic prostate cancer a $300m market opportunity with radionuclide therapy is $2Bn few beneficial options for patients opportunity in late-stage disease alone TLX250-CDx: Renal cancer pat
Slide 10: TLX591-CDx (PCa Imaging)
▪ PSMA11 is the most widely used TLX591-CDx (PCa Imaging) PSMA prostate cancer agent ▪ In over 150 publications, PSMA11 For personal use only 68Ga-HBED- Prostate-Specific has demonstrated excellent Membrane detection of prostate cancer from CC-PSMA11 Antigen (PSMA) high-risk pre-prostatectomy patien
Slide 11: Early TLX591-CDx Adoption is Growing Fast
Early TLX591-CDx Adoption is Growing Fast For personal use only 1 ✓ >100 sites around the world use the product routinely or 49 5 in clinical trials ✓ Mostly large cancer centres that are capable of doing 3 10-15 pts a week (upon 55 product approval) 8 2 8 1 1 ✓ Sales on track to deliver 7 3 between
Slide 12: TLX591 (PCa Therapy)
Retrospective cross-trial comparison between TLX591 (PCa Therapy) 177Lu-PSMA-617 and 177Lu-huJ591 (TLX591) Median overall For personal use only survival (OS) is >40 months (hu591) vs 15 177Lu-DOTA- Prostate-Specific months Membrane huJ591 Antigen (PSMA) 6 Ph I/II trials Phase III >200 patients ▪ Ant
Slide 13: Fractionation Addresses Hematologic Toxicity
Fractionation Addresses Hematologic Toxicity For personal use only Single dose 70 mCi/m2 Traditionally, antibody (mAb)- directed radiotherapies were considered to have an unacceptable hematologic toxicity profile because of the long circulation time However, fractionated dosing – as is done with sma
Slide 14: Objective PSA Response
Objective PSA Response* For personal use only 45 mCi/m2 ×2 40 mCi/m2 ×2 Time in months from treatment PSA waterfall plot showing each patient’s best PSA response. Patients treated with lower doses of 177Lu-J591 (20-35 mCi/m2 ×2) are indicated in light gray; patients who received recommend phase 2 do
Slide 15: Off-Target Irradiation – Quality of Life Matters
Off-Target Irradiation – Quality of Life Matters For personal use only Lacrimal, Parotid, Small molecule-based Submandibular approaches such as (salivary) glands PSMA-617 (Endocyte / Novartis) are able to hit Liver endogenous PSMA (preferred expression whereas clearance antibodies are only Spleen, L
Slide 16: TLX250-CDx (Renal Ca Imaging)
TLX250-CDx (Renal Ca Imaging) Benign For personal use only 89Zr-DFO- Carbonic Anhydrase IX girentuximab (CAIX) Malignant >300 patients imaged with Phase III ccRCC 124I, 89Zr (Confirmatory) ▪ Prior Ph III trial with 124I NCT03849118 ▪ ZIRDOSE 124I to 89Zr bridging ▪ 252 patient global phase III study
Slide 17: TLX250 (Renal Ca Therapy)
TLX250 (Renal Ca Therapy) ▪ Average tumor increase (RECIST) in For personal use only 177Lu-DOTA- Carbonic the 3 months prior to Anhydrase IX treatment was 40.4% girentuximab (CAIX) ▪ In the 3 months after 37 patients treatment it was 5.5% with 177Lu Phase II ▪ >10 months PFS in heavily pre-treated S
Slide 18: TLX101 (Glioblastoma Therapy)
Image-based evaluations with MRI and PET are invaluable for measuring treatment TLX101 (Glioblastoma Therapy) response in GBM patients For personal use only Case Study: LAT-1 131I-IPA • Treatment: 2GBq TLX101 single dose I.V. (Large Amino Acid Baseline F/U month 4 • Safety: no acute, sub-acute or de
Slide 19: Multiple Milestones and Readouts in 2019
Multiple Milestones and Readouts in 2019 For personal use only Q1 Q2 Q3 Q4 US/JP2 IND Filed Enrolment Complete Imaging Cancer Renal (Phase III) Therapy (Phase I/II) Mfg completed US IND Filed FPI Update Interim Results Info Package to FDA Pre-NDA meeting NDA Go/No Go Prostate Cancer Imaging NDA1 (US
Slide 20: Extensive Supply Chain and Production Network Established
Extensive Supply Chain and Production Network Established For personal use only ✓ Key partners in place ✓ For clinical trials and early commercial product roll-out ✓ Discussion ongoing with partners for MENA, Asia and LATAM Backup 20
Slide 21: Competitive Landscape
Competitive Landscape For personal use only ▪ Very few companies in the radiopharmaceutical / MTR space with a late-stage product pipeline. Telix is a unique company ▪ Moderate competition in prostate and GBM, zero meaningful competition in renal cancer for our drug class ▪ Novartis (Endocyte / AAA)
Slide 22: Valuation Benchmarks: Plenty of Sector Activity
Valuation Benchmarks : Plenty of Sector Activity For personal use only ▪ Competing PhIII prostate ▪ Privately held UK program company, majority held ▪ Sold to Novartis in Dec by Syncona LIC. 2018 for USD $2.1Bn ▪ Est market cap of (AUD $2.9Bn) ~£200m (AUD $370m) ▪ Telix is successfully ▪ Limited pip
Slide 23: Management Team
Management Team For personal use only Dr. Christian Behrenbruch (Co-Founder, MD and CEO) Dr. Jyoti Arora (Director of Manufacturing Operations) Chris has 20 years of healthcare executive experience as CEO, Mirada Solutions, CTI Jyoti has extensive experience in project management, operations and GMP
Slide 24: Board of Directors
Board of Directors For personal use only Mr. H. Kevin McCann AM Ms. Jann Skinner Chairman Non-executive Director Kevin is currently Chairman of Citadel Group and former Chairman Ms. Skinner, B Com, FCA, FAICD has extensive experience in audit, accounting and in of Dixon Hospitality, Macquarie Bank L
Slide 25: International Operations
International Operations For personal use only Dr. Shintaro Nishimura (President, Telix Japan) Shintaro is a highly-experienced drug development and commercialization professional, with particular emphasis on the use of molecular imaging in drug development. Prior to Telix, Shintaro held senior posi
Slide 26: Scientific Advisory Board
Scientific Advisory Board For personal use only Dr. Rodney Hicks Dr. Neil Bander Chair of Urology at Weill Cornell Medical Centre (NY, USA). First led the Chief of Nuclear Medicine and Radiology, Peter MacCallum Cancer Centre development of PSMA-targeting radiopharmaceuticals for prostate (Melbourne
Slide 27: Near-Term Catalysts
Near-Term Catalysts For personal use only ✓ End-June : report outcome on pre-Phase III IND meeting with FDA for ZIRCON (renal imaging) ✓ End-July : report outcome on FDA pre-NDA meeting with FDA for illumetTM (prostate imaging) ✓ End-July : Commercial / collaboration update for renal therapy program
Slide 28: www.telixpharma.com
For personal use only www.telixpharma.com
Telix Pharmaceuticals — Jefferies Healthcare Conference 2019 on 6ix